Systems, devices, and methods for substernal leads for applying cardiac treatment

Abstract

An implantable lead configured to be implanted in an anterior mediastinum of a patient. The implantable lead includes a generator interface and a lead body coupled to the generator interface. The generator interface is configured to couple the implantable lead to a generator of an implantable treatment device. The lead body includes a sternal portion configured to be positioned in the anterior mediastinum to engage a posterior portion of a sternum of the patient, and a heart wall portion configured to be positioned in the anterior mediastinum to engage a heart wall of a heart of the patient. At least one of the sternal portion or the heart wall portion is configured to deliver treatment energy to the heart of the patient.

Description

SYSTEMS, DEVICES, AND METHODS FOR SUBSTERNAL LEADS FOR APPLYING CARDIAC TREATMENTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 664,574, filed June 26, 2025, entitled “Systems, Devices, and Methods for Substernal Leads for Applying Cardiac Treatment,” the disclosure of which is incorporated herein by reference in its entirety.BACKGROUND

[0002] The embodiments described herein relate generally to the leads of implantable medical devices and more particularly, to systems, devices, and methods for using substernal, epicardial, and / or other extracardiac leads of an implantable monitoring, diagnostic, and / or treatment device.

[0003] The human heart is a mechanical pump for moving blood through the body and is driven by cardiac electrical activities. It therefore follows, that cardiac electrical abnormalities (cardiac electrical signals) can result in abnormalities in the function of the mechanical pump, which in turn, may hinder the ability of the heart to move blood through the body. Moreover, abnormal heart function such as sudden cardiac arrest, arrhythmias, and / or the like can lead to sudden cardiac death.

[0004] An implantable cardioverter defibrillator (ICD) is a medical device that is designed to address and / or treat cardiac tachyarrhythmias, heart failure, and other cardiac events that can lead to sudden cardiac death. In general, ICDs use cardiac signals (e.g., physiological or pathophysiological bio-signals from the heart, such as cardiac electrical signals, cardiac mechanical signals, hemodynamics, and / or the like) to make ICD therapy decisions relying on sensitive and specific parameters (e.g., data from sensors) and / or detection algorithms. One of the consistent challenges of ICDs, however, is the delivery of unnecessary and / or inappropriate ICD therapy. These therapies include a delivered shock (high-energy defibrillation shocks) or cardiac pacing (low-energy pacing shocks). Such ICD therapy can be painful or uncomfortable annoyances to a patient and reducing inappropriate shocks has been demonstrated to reduce all-cause mortality in patients using an ICD.

[0005] The Cardiac Arrhythmia Suppression Trial (CAST) demonstrated that clinical benefit evaluation needs a desirable clinical end point of related mortality (survival). As a surrogateendpoint, ventricular premature heart beats do not provide a good evaluation of clinical benefit for patient outcomes. For ICDs to make optimized therapy decisions for patient outcomes, it is desirable for ICDs to mimic clinical practice and / or base therapy decisions on high quality clinical data. In clinical practice, making an optimum decision to manage an arrhythmia focuses not only on electrocardiogram (ECG) performance and diagnosis, but also on the patient's hemodynamic status and other clinical conditions.

[0006] ICDs simulate ECG-based arrhythmia management decision-making by cardiologists or electrophysiologists using cardiac signals recorded by intravenous or extra-cardiovascular “leads” (or sensors incorporated into such leads). In addition to recording cardiac signals, leads include electrodes that are used to deliver shock therapy and / or cardiac pacing. In traditional ICD implantation procedures, leads are delivered into one or more chambers of the heart transvenously. However, the transvenous delivery of traditional ICD leads and / or the indwelling of the leads can result in lead-related complications. In an effort to mitigate such complications, some known ICDs include leads that may be subcutaneous and / or substernal. However, present leads may have inconsistent and / or undesirable placement in the substernal space which may result in inappropriate shocks. The placement of some known leads in the substernal space (e.g., the anterior mediastinum located between the anterior surface of the sternum and the heart) can result in increased cardiac pacing thresholds, which may be undesirable for certain patients. For example, the anterior mediastinum is mainly composed of loose connective tissue and leads in this space may be associated with relatively high pacing thresholds and / or may collect relatively unstable or unclear cardiac signal readings. Furthermore, current leads may prohibit or limit the ability of leads to leverage anti -tachycardia pacing to treat spontaneous ventricular tachycardia without triggering a painful, high-energy shock.

[0007] Thus, there is a need for substernal ICD leads that allow for consistent placement, reduced pacing thresholds, and / or reduced inappropriate shocks.SUMMARY

[0008] In some embodiments, an implantable lead configured to be implanted in an anterior mediastinum of a patient. The implantable lead includes a generator interface and a lead body coupled to the generator interface. The generator interface is configured to couple the implantable lead to a generator of an implantable treatment device. The lead body includes a sternal portion configured to be positioned in the anterior mediastinum to engage a posteriorportion of a sternum of the patient, and a heart wall portion configured to be positioned in the anterior mediastinum to engage a heart wall of a heart of the patient. At least one of the sternal portion or the heart wall portion is configured to deliver treatment energy to the heart of the patient.

[0009] In some embodiments, a lead for an implantable cardioverter defibrillator (ICD) is configured to be implanted in an anterior mediastinum of a patient. The lead includes a generator interface, a shock coil, and a pacing electrode. The generator interface is configured to couple the lead to a generator of the ICD. The shock coil is configured to deliver defibrillation treatment energy generated by the generator. The shock coil is disposed on a sternal portion of the lead that is configured to engage a posterior portion of a sternum of the patient when the lead is implanted in the anterior mediastinum. The pacing electrode is configured to deliver pacing treatment energy generated by the generator. The pacing electrode is disposed on a heart wall portion of the lead that is configured to substantially contact a heart wall of the patient when the lead is implanted in the anterior mediastinum.

[0010] In some embodiments, a lead for an implantable cardioverter defibrillator (ICD) is configured to be implanted in an anterior mediastinum of a patient. The lead includes a generator interface, an electrical sensor, a pressure sensor, and a treatment portion. The generator interface is configured to couple the lead to a generator of the ICD. The electrical sensor is configured to detect an electrical signal radiating from a pericardium of a heart of the patient. The pressure sensor is configured to detect a pressure in the anterior mediastinum. The treatment portion of the lead includes a shock coil and a pacing electrode. The treatment portion is configured to support the lead between a sternum of the patient and a heart wall of the patient when the lead is implanted in the anterior mediastinum.

[0011] In some embodiments, a diagnostic / treatment device is configured to be implanted in a patient. The diagnostic / treatment device includes a lead and a sensing device. The lead is configured to implanted in an anterior mediastinum of the patient. The lead includes an electrical sensor configured to detect electrical signals radiating from a pericardium of a heart of the patient and a pressure sensor configured to detect pressure signals in the anterior mediastinum. The sensing device is configured to be coupled to the lead via a lead interface. The sensing device includes a memory and a processor configured to execute instructions stored in the memory that cause the processor to (i) determine a diagnostic status based at least in part on data from the electrical sensor, (ii) confirm the diagnostic status based at least in parton data from the pressure sensor, and (iii) in response to confirming the diagnostic status, generate at least one action associated with the diagnostic status.BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1A schematically depicts a diagnostic / monitoring system engaging a patient, according to an embodiment.

[0013] FIGS. IB and 1C schematically depict embodiments of an implantable cardioverter defibrillator (ICD) engaging with a patient, according to an embodiment.

[0014] FIG. 2 schematically depicts an ICD lead engaging with a patient, according to an embodiment.

[0015] FIG. 3 depicts an ICD lead, according to an embodiment.

[0016] FIGS. 4A-4C depict various views of an ICD lead, according to an embodiment.

[0017] FIGS. 5A-5B depict various view of an ICD lead, according to another embodiment.

[0018] FIG. 6 depicts an ICD lead, according to another embodiment.

[0019] FIG. 7 depicts a packaged ICD lead, according to an embodiment.

[0020] FIG. 8 depicts graphs of sensor outputs, according to an embodiment.

[0021] FIGS. 9A-9E depict various views of an ICD lead, according to another embodiment.

[0022] FIGS. 10A-10E depict various views of an ICD lead, according to another embodiment.DETAILED DESCRIPTION

[0023] The embodiments described herein relate generally to systems, devices, and / or methods for applying cardiac treatment. In some embodiments, a cardiac treatment device (e.g., cardiac therapy device, defibrillator, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy defibrillator (CRT-D), etc.), pacemaker, etc. may be configured to deliver shock therapy and / or cardiac pacing based at least in part on one or more characteristics associated with a heart of a patient while decreasing a likelihood of delivering undesirable, incorrect, and / or inappropriate shock therapy and / or cardiac pacing. For example, the cardiac treatment device can include and / or can be in communication with any number of sensors configured to detect one or more characteristics associated with the heart. The one or more characteristics can also include characteristics that are not detected by the sensors, such as patient demographic and / or health data (e.g., age, genetic information, health records, etc.).The one or more characteristics can be correlated, corroborated, compared, and / or verified, and used to determine whether to provide treatment. In some implementations, the one or more characteristics can be used to determine the type of treatment. In some implementations, the determining the type of treatment can include determining which lead to use to apply treatment, if the cardiac treatment device includes more than one lead.

[0024] For example, the shock therapy can include a relatively high energy defibrillation shock treatment and a relatively low energy pacing treatment (e.g., anti-tachycardia pacing, antibradycardia pacing, post-shock pacing, heart failure treatment, etc.). The ICD can include a generator configured to generate treatment energy based on inputs associated with the patient (e.g., cardiac signals and / or other patient data / information) The ICD can include a lead operatively coupled to the generator that is configured to deliver both relatively high energy defibrillation shocks and relatively low energy cardiac pacing. In some embodiments, the ICD lead can include features that allow for the ICD lead to deliver the relatively high energy defibrillation shocks and the relatively low energy pacing along different portions of the lead and / or anatomy of the patient. For example, the relatively high energy defibrillation shocks can be delivered along a portion of the ICD lead that is configured to engage or substantially engage a sternal area or anterior sternal wall of the patient and the relatively low energy pacing can be delivered along a portion of the ICD that is configured to engage (e.g., contact) or substantially engage the heart wall of the patient (e.g., along the fibrous pericardium). In some embodiments, the ICD lead can include sensing electrodes configured to sense characteristics (e.g., cardiac electrical signals, cardiac mechanical signals, etc.) associated with the heart. In some embodiments, the placement of such sensors along the ICD can be based at least in part on the type of cardiac signal the sensor is configured to detect. For example, it may be desirable for a sensor configured to detect cardiac electrical signals to be in contact with or in close proximity to the fibrous pericardium of the heart. Conversely, it may be desirable for a sensor configured to detect mechanical signals such as pressure changes to be spaced apart from the heart.

[0025] The ICD lead can include a generator interface that can include one or more connections, each connection associated with one or more treatment or sensing features of the ICD lead. In some embodiments, the ICD lead can include one or more shock coils configured to deliver high energy defibrillation treatment. In some embodiments, the one or more shock coils are positioned along a portion or length of the ICD lead that is configured to engage, contact, and / or substantially contact the sternum or substemal space of the patient when implanted. In some embodiments, the portion(s) of the ICD lead can include one or moresensors configured to measure characteristics (e.g., cardiac and / or respiratory signals) associated with the patient. The ICD lead can include one or more electrodes. The electrodes can include pacing electrodes and / or sensing electrodes. In some embodiments, some or all of the electrodes can operate as both pacing electrodes and sensing electrodes. In some embodiments, the electrodes are located on a portion of the ICD lead that is configured to engage, contact, and / or substantially contact the heart wall of the patient. For example, the electrodes can be configured to engage the fibrous pericardium of the heart. In some embodiments, substantially contacting the heart wall can include being near the heart wall. In some embodiments, the ICD lead can include looped, nonlinear, or 3 -dimensional portions that allow for the electrodes to engage the heart wall while the sternal portions engage the sternum. In some embodiments, the ICD lead can include more than one looped portion to allow for more than one electrode to engage the heart wall. In some embodiments, the ICD lead can be configured to allow for slight movement, deformation, deflection, and / or reconfiguration so that the electrodes can maintain position along the heart wall while the patient is moving and / or with the movement of the heart during operation. In some embodiments, the ICD lead can include a stabilizer that is configured to stabilize and / or substantially maintain the position of at least a portion of the ICD lead in the substernal space. In some embodiments, the stabilizer may be a looped (e.g., curved, etc.) portion at the distal end or distal end portion of the ICD lead.

[0026] In some embodiments, the ICD can include an epicardial lead configured to be implanted in the epicardium of the heart. In some embodiments, the epicardial lead can be placed on the epicardium and / or otherwise in the pericardial cavity of the heart. In some embodiments, the epicardial lead is a primary lead. In some embodiments, the epicardial lead is a backup to another lead, such as a substernal lead. In such embodiments, the substernal lead can be disposed in an anterior mediastinum of the patient and in contact with the fibrous pericardium of the heart. In some embodiments, the epicardial lead, whether implemented as the primary or backup lead, can be configured to deliver relatively low-energy treatment used for cardiac pacing.

[0027] In some embodiments, including the epicardial lead can allow the ICD to provide pacing at lower pacing thresholds than, for example, a system including only a substernal lead disposed in the anterior mediastinum. In some embodiments, the ICD can be configured to allow for any type of cardiac pacing impulse (e.g., low-energy impulses used for antitachycardia pacing, heart failure treatment, cardiac resynchronization therapy (CRT), anti-bradycardia pacing, post-shock pacing, etc.) to the heart via the epicardial lead. Antitachycardia 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, for 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). In some embodiments, pacing for CRT can include pacing both the right and left ventricles to target hemodynamic function to treat heart failure.

[0028] In some embodiments, systems, devices, and / or methods described herein can be used, inter alia, to reduce undesired and / or inappropriate treatments provided by an ICD implanted in a patient. For example, the positioning of the ICD leads described herein in the substernal space can allow for desirable spacing between the heart and the shock coil and desirable contact and / or minimal spacing between the pacing and / or sensing electrodes and the heart wall. Furthermore, the ICD leads described herein are configured to be stable inside the body (e.g., the anterior mediastinum) to decrease or prevent the likelihood of additional corrective procedures as a result of the ICD lead being in an undesirable position.

[0029] 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.

[0030] 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 the exclusion of more than one such component, feature, aspect, etc. (and / or vice versa) unlessexpressly stated otherwise. The various singular / plural permutations may be expressly set forth herein for sake of clarity.

[0031] 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.

[0032] 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.”

[0033] 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.

[0034] 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 / or relationship stated may be desirable, it should be understood that some variance may occur asa 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.

[0035] 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.

[0036] As used herein, the term “cardiac signals” generally refers to signals from one or more sensors that can include physiological or pathophysiological bio-signals radiating from the heart or otherwise present in the substernal space (or anterior mediastinum). Such signals can be, for example, cardiac electrical signals or cardiac non-electrical signals. Cardiac electrical 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, 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.

[0037] As used herein, the term “cardiac pacing” generally refers to the delivery of relatively low energy shocks used to “pace” the heart in response to arrythmia. Examples of cardiac pacing can include, but are not limited to, anti-tachycardia pacing, anti-bradycardia pacing, post-shock pacing and / or the like. Anti-tachycardia pacing can include, for example, pacing shocks that provide therapy to treat ventricular tachycardia (e.g., a heartbeat that is faster than desired). Anti-bradycardia pacing can include, for example, pacing shocks that provide therapy to treat bradycardia (e.g., a heartbeat that is slower than desired). Post-shock pacing caninclude, for 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).

[0038] 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 polymer material may be biodegradable or non-biodegradable. Examples of suitable biodegradable polymers include polylactides, polyglycolides, polylactide-co-glycolides, polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones, polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes, biodegradable polyamides (nylons), and / or blends and copolymers thereof. Examples of non-biodegradable polymers include non-degradable polyamides (nylons), polyesters, polycarbonates, polyacrylates, polymers of ethylene-vinyl acetates and other acyl substituted cellulose acetates, non-degradable polyurethanes, polystyrenes, polyvinyl chloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonate polyolefins, polyethylene oxide, and / or blends and copolymers thereof.

[0039] Non-limiting examples of suitable biocompatible polymer materials can include 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, polyvinyl fluoride, 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.

[0040] 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 embodimentsmay 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.

[0041] FIG. 1A is a schematic illustration depicting a diagnostic / monitoring system 10 engaging a patient P according to an embodiment. The diagnostic / monitoring system 10 (referred to herein as “system 10”) includes a sensing device 11 having and / or in communication with a lead 14 that has a set of sensor(s) 15. In some embodiments, the sensing device 11 is configured to be implanted in the patient P. For example, the lead 14 of the sensing device 11 is configured to be placed or implanted between a heart H and / or the lungs L and a sternum S of the patient P, as depicted.

[0042] In some implementations, the sensing device 11 (or at least the lead 14) can be permanently implanted or temporarily placed between the heart H and the sternum S. For example, the sensing device 11 (or at least the lead 14) can be implanted in the anterior mediastinum. The sensing device 11 can be any suitable device configured to perform any number of diagnostic, monitoring, and / or sensing processes (or any other action(s)) based at least in part on data received from the set of sensor(s) 15 of the lead 14. In some embodiments, for example, the sensing device 11 can be configured to analyze and / or process data (including, but not limited to, data from the set of sensor(s) 15) during monitoring to determine one or more diagnosis, health event, changes in measurements over time, trends in measurements, anomaly associated with the health of the patient P, and / or one or more actions to take based on the data. The determinations and / or the detected characteristics of the sensing device 11 can be associated with, for example, the health and / or functioning of the patient’s heart H, lungs L, and / or other portions of the patient’s body. In some embodiments, the sensing device 11 may be an ambulatory device that can allow for a patient P to walk and / or complete other daily activities while having the sensing device 11 implanted in the body. For example, the sensing device 11 can be used for ambulatory monitoring that can provide monitoring of the patient P outside of a clinical and / or hospital setting. The sensing device 11 may be referred to as an “ambulatory device” as it may be implanted using minimally invasive procedures and function so as to not obstructively impact the life of the patient P.

[0043] In some embodiments, the sensing device 11 can be implemented in or as a treatment and / or therapy device such as an implantable cardioverter-defibrillator (ICD), a cardiac resynchronization therapy defibrillator (CRT-D), a pacemaker, and / or any other suitable device. For example, the sensing device 11 can be configured to analyze and / or process data (including, but not limited to, data from the sensor(s) 15) to inform and / or to make one or more decisions associated with providing treatment and / or therapy to the patient P (or to take any other suitable action). For example, in the case of an ICD, the sensing device 11 can be configured to determine whether to provide electric shock therapy (e.g., a defibrillation shock, cardiac pacing, and / or the like) to the heart H of the patient P based at least in part on data received from the set of sensor(s) 15. In some embodiments, the sensing device 11 can be configured to provide and / or perform diagnostic and / or monitoring as well as treatment functionality (e.g., via the lead). Specifically, when the sensing device 11 is implemented in or as a treatment and / or therapy device, the sensing device 11 can be configured to detect a trigger (e.g., health event, etc.) as to inform or confirm an urgent treatment decision. The lead 14 can then deliver any generated treatment or therapy energy to one or more portions of the patient (e.g., the heart H). When implemented to provide and / or perform diagnostic and / or monitoring, the sensing device 11 can monitor health characteristics associated with the patient over a period of time to determine if the dynamics (e.g., changes, etc.) of the health characteristics indicate an anomalous trend that may be indicative of a pathology, disease, congenital defect, anatomical defect, and / or the like.

[0044] The lead 14 of the sensing device 11 is configured to be implanted in and / or access various portions of the mediastinal space between any combination of the heart H, the lungs L, and the sternum S. For example, the anterior mediastinal space is a volume in the thoracic cavity between the right lung and the left lung (lungs L) and between the heart H and a posterior surface of the sternum S. As such, the functioning and / or changes in the functioning of the heart H and lungs L affect the pressure within the anterior mediastinum. The lead 14 can be configured to place the sensor(s) 15 (or treatment elements, coils, etc., not shown) in a desired location. For example, the lead 14 can be configured to position at least one of the sensor(s) 15 against the heart H to measure cardiac electrical signals and / or any other signals within the anterior mediastinum. When the sensing device 11 is implemented in or as a treatment and / or therapy device, the lead 14 includes one or more treatment elements such as shock coils, pacing electrodes, and / or the like allowing the lead 14 to deliver any generated treatment or therapy energy to one or more portions of the patient (e.g., the heart H).

[0045] The set of sensor(s) 15 included on or coupled to the lead 14 can include any number of sensors configured to detect bio-signals and / or other signals associated with a patient. For example, the set of sensor(s) 15 can include one or more sensors implanted in the body and configured to detect and / or measure one or more characteristics and / or signals associated with the cardiovascular system (e.g., heart H), the respiratory system (e.g., lungs L), and / or any other suitable system or portion of the body. In some embodiments, one or more sensors can be disposed outside of the body (e.g., included in a wearable such as a smartwatch, fitness tracker, an insulin pump, a thermometer, a pulse oximeter, a smart ring, and / or the like). In some embodiments, the set of sensor(s) 15 can include a cardiac electrical sensor configured to measure electrical signals of the heart H such as electrocardiogram (ECG) signals and / or electrogram signals. In some embodiments, the sensor(s) 15 can include sensors external to the patient P configured to measure cardiac electrical signals. The set of sensor(s) 15 can include one or more pressure sensors. For example, the pressure sensor can be configured to measure the pressure or changes in pressure within the anterior mediastinum. In some embodiments, the set of sensor(s) 15 can include additional sensors such a photoplethysmography sensor (PPG) sensor (or other optical sensor), an oxygen saturation (SpO2) sensor, an accelerometer, a temperature sensor, an acoustic sensor, an ultrasound sensor, an optical sensor, and / or the like. In some embodiments, the sensor(s) 15 can be configured to monitor and / or measure multiple characteristics associated with the patient P, which in turn, can be used to determine, define, and / or confirm one or more treatment decisions, diagnoses, diagnostic predictions, anomalies, health events, and / or the like. As described in detail herein, the data associated with and / or indicative of the multiple characteristics and sources can be correlated, aggregated, confirmed, verified, etc. to allow for more accurate and / or precise diagnostic and / or treatment decisions than a diagnostic and / or treatment decision using just one characteristic.

[0046] In some embodiments, a first sensor can be configured to detect and / or measure at least one characteristic of or associated with the heart H and a second sensor configured to detect and / or measure at least one characteristic within the anterior mediastinum that is different from the characteristic(s) measured by the first sensor. The second sensor may be configured to detect and / or measure a pressure in the space (e.g., portion of the body) in which the second sensor is placed (e.g., in the anterior mediastinum). Implanting the lead 14 with the set of sensors 15 in the desired space in the body (e.g., the anterior mediastinum) may allow the sensing device 11 to monitor, diagnose, and / or treat a patient’s health (e.g., the sensing device 11 may be a diagnostic device only, a monitoring device only, a therapeutic device only, or anysuitable combination of diagnostic device (or function), monitoring device (or function), and therapeutic device (or function)).

[0047] In some embodiments, the coordination of the data obtained from the set of sensor(s) 15 can be used to determine and / or monitor patient health information. This can be performed, for example, by selectively separating the data received from one or more sensor(s) 15 as a function of the source, characteristic, and / or bio-signal being detected. For example, any suitable amplification and filtering (either digitally or through physical circuitry) can be performed on raw sensor data to separate the data into multiple signals, vectors, modalities, characteristics, etc. In some embodiments, the sensor(s) 150 can include one or more pressure sensors that can sense and / or detect pressures and / or pressure changes in, for example, the anterior mediastinum. In such embodiments, the data can be separated based on the physiological and / or pathophysiological characteristic producing the pressure signal. For example, the pressure data can be separated (e.g., via amplification and / or filtering) into a respiratory pressure curve, a cardiac pressure curve, various cardiac pressures associated derived from the pressure measurements, and a mediastinal pressure curve. Moreover, understanding the individual pressure curves associated with the physiologic and / or pathophysiologic cause of the pressure changes can allow for improved monitoring (and / or improved specificity of the collected or measured data), which in turn, can result in meaningful health alerts and / or decisions (with reduced false positives and / or false negatives).

[0048] In some embodiments, the system 10 can be implemented in any suitable diagnostic and / or treatment device as described above. For example, FIGS. IB andlC are examples of a system (e.g., similar to or substantially the same as the system 10) with a sensing device implemented in or as an ICD. It should be understood, however, that the embodiments shown in FIGS. IB andlC can be implemented in or as other implantable diagnostic / treatment devices as described above.

[0049] FIGS. IB and 1C schematically depict an implantable cardioverter defibrillator (ICD) system 100 including an ICD 110 engaging a patient P according to an embodiment. The ICD 110 is implanted (or implantable) in the patient P. The ICD system 100 can be utilized for treating certain conditions or states of a heart H of the patient P via certain electric treatment therapies, while reducing a likelihood of providing undesired, unnecessary, and / or inappropriate treatments (e.g., “false positives” or “inappropriate shocks”). In some embodiments, the ICD 110 can be configured to provide relatively high energy defibrillation shock treatment and / or relatively low energy pacing treatment, such as anti-tachycardia pacing,anti-bradycardia pacing, post-shock pacing, heart failure treatment, etc.). The ICD 110 is configured to receive and / or process sensor signals associated with one or more characteristics of the heart H or any other portion or part of the patient P.

[0050] The ICD 110 includes an ICD generator 120, an ICD lead 140, and, in some embodiments, sensor(s) 150. In some embodiments, the ICD 110 can receive one or more signals from any number of sensors on the ICD lead 140 and / or any other sensor (e.g., the sensor(s) 150). The ICD generator 120 is configured to determine when to provide treatment and to generate treatment energy that can be sent to the heart H via the ICD lead 140. In some embodiments, the ICD generator 120 can be placed on the pectoralis major muscle of the patient P, behind the pectoralis major muscle (e.g., in a pocket below the clavicle bone), on the abdomen, along the left exterior thorax, or elsewhere on or in the body of the patient P. In some embodiments, the ICD generator 120 can be similar to and / or substantially the same as any of the ICD generators described in U.S. Patent Application No. 18 / 529,544, filed December 5, 2023, entitled “Systems, Devices, and Methods for Improving Patient Outcomes in Implantable Cardioverter Defibrillators,” (“the ‘544 application”), International Patent Application No. PCT / US2024 / 042740, filed August 16, 2024, entitled “Systems, Devices, and Methods for Improving Decision-Making of Implantable Devices Using Multiple Data Sources” (“the ‘740 PCT”), and / or International Patent Application No. PCT / US2025 / 013954, filed February 7, 2025, entitled “Systems, Devices, and Methods for Health Monitoring via Implantable Devices in the Anterior Mediastinum” (“the ‘954 PCT”), the disclosure of each of which is incorporated herein by reference in its entirety. Accordingly, certain functions, portions, and / or aspects of the ICD generator 120 are briefly provided below for context but are not described in further detail.

[0051] As shown in FIG. IB, the ICD generator 120 can include a processor 122, a memory 124, a power system 126, a communication device 128, and a lead interface 130. The processor 122 is configured to execute and / or perform the operations of the ICD generator 120. The processor 122 can be, for example, a hardware based integrated circuit (IC), or any other suitable processing device configured to run and / or execute a set of instructions or code. For example, the processor 122 can be a general-purpose processor, a central processing unit (CPU), an accelerated processing unit (APU), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), a programmable logic array (PLA), a complex programmable logic device (CPLD), a programmable logic controller (PLC), and / or the like. The processor 122 can be operatively coupled to the memory 124 through a system bus (forexample, address bus, data bus, and / or control bus). As described in further detail herein, the processor 112 is configured to execute instructions, code, modules, applications, etc. stored in the memory 114.

[0052] The memory 124 stores instructions that are executed by the processor 122. The memory 124 can be, for example, a random-access memory (RAM), a memory buffer, a hard drive, a read-only memory (ROM), an erasable programmable read-only memory (EPROM), and / or the like. In some instances, the memory 124 can store, for example, one or more software programs and / or code that can include instructions to cause the processor 122 to perform one or more processes, functions, and / or the like. In some implementations, the memory 124 can include extendable storage units that can be added and used incrementally. In some instances, the memory 124 can be remotely operatively coupled with a compute device (not shown). For example, a remote database device can serve as a memory (or at least a portion of a memory) and be operatively coupled to the compute device (e.g., via a network or the like). The memory 124 can, for example, store and / or include any suitable instructions that, when executed, can cause the processor 122 to perform one or more processes, functions, etc. associated with operating the ICD generator 120 and / or any other portions of the ICD system 100, as described in detail in the ‘544 application, the ‘740 PCT, and / or the ‘954 PCT.

[0053] The power system 126 is configured to store energy for use by the ICD and to generate treatments for delivery to the patient P. In some embodiments, the power system 126 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 126 includes a primary cell battery and a rechargeable battery. In some embodiments, the power system 126 can be configured to charge automatically (e.g., via patient P movement) or wirelessly (e.g., via inductive charging). The power system 126 can also be configured to generate a therapy signal. For example, the therapy signal can include treatment energy for at least one of cardiac pacing and / or defibrillation 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 power system 126 is controlled via the processor 122 executing instructions stored in the memory 124.

[0054] The communication device 128 is configured to allow the ICD generator 120 to communicate with one or more devices such as, for example, an external device, an implantable device, controller, server, etc. (e.g., a compute device, controller, etc. of a medical professional,the patient P, and / or the like). The communication device 128 can be configured to send information via one or more networks using any suitable communication mode (e.g., Bluetooth, Wi-Fi, near field communication (NFC), and / or the like). The communication device 128 can be configured to send information with a wired or wireless communication device. In some embodiments, the communication device 128 may be optional.

[0055] In some implementations, the communication device 128 can send information to a user and / or a compute device controlled by a user regarding the ICD 110 such as battery level, information regarding therapies delivered to the heart H of the patient P, device status, and / or the like. The communication device 128 can also send information regarding the patient P, such as real-time or substantially real-time information, data, and / or other signals associated with the heart H (e.g., data from the ICD lead 140, the sensor(s) 150, and / or any other suitable data). In some embodiments, the communication device 128 can receive signals for augmenting and / or at least partially controlling the operation of the ICD 110. For example, the communication device 128 can receive signals (e.g., from a controller or external compute device) associated with patient information and / or other operational instructions for determining when the ICD generator 120 generates a therapy, power levels associated with therapy, pacing and / or other thresholds (e.g., for anti-tachycardia pacing, bradycardia pacing, post-shock pacing, and / or any other suitable pacing therapy), and / or the like. In some embodiments, the communication device 128 can be configured to send information and / or signals to an external compute device and / or server that is / are configured to perform machine learning processes. The communication device 128 can also receive information from the external compute device and / or the server that may include instructions, firmware, updates, etc. based on an output from a machine learning model.

[0056] In some embodiments, determining therapy such as pacing can include determining a pacing threshold prior to implantation of the ICD 110. For example, pacing energy having a higher voltage than is used for pacing can be applied to the heart of the patient to pace the heart (e.g., overpace the heart at 100 beats per minute (bpm)) and then the voltage can be reduced until the heart is no longer “captured” by the pacing energy, and returns to its own rhythm. As such, the minimum pacing threshold is the minimum voltage that “captures” the heart. In some embodiments, a desired pacing threshold can be about 6 volts or less. In some embodiments, a desired pacing threshold can be about 5 volts or less. In some embodiments, a desired pacing threshold can be about 3 volts or less.

[0057] The ICD lead 140 is operatively coupled to the ICD generator 120 via a lead interface 130 and / or a generator interface 142. In some embodiments, the ICD lead 140 can extend away from the ICD generator 120 via the generator interface 142. The generator interface 142 can be a conduit that includes one or more signal / power carrying wire. The ICD lead 140 is configured to deliver treatment to the patient P and / or the heart H of the patient P.

[0058] The lead interface 130 is configured to couple (e.g., physically couple or at least operably couple) the ICD generator 120 to the ICD lead 140 to allow data signals and / or electric power (e.g., for therapy) to be transferred therebetween. In some embodiments, the lead interface 130 can be configured to format data signals and / or electric power transferred between the ICD generator 120 and the ICD lead 140 into any suitable format allowing, for example, the processing of sensor data or the like by the ICD generator 120 and / or the application of therapy by the ICD lead 140. The generator interface 142 and / or the lead interface 130 may be a flexible interface to provide flexibility for the continuous movement of the heart H and allowing the ICD lead 140 or portions thereof to be in contact with or substantially in contact with the heart H. In some embodiments, the lead interface 130 and / or the generator interface 142 can include plugs, connectors, and / or the like configured to selectively couple the ICD generator 120 to the ICD lead 140. In some embodiments, the lead interface 130 and / or the generator interface 142 include separate connections for different portions of the ICD lead 140. For example, the lead interface 130 and / or the generator interface 142 can include one or more connector for high powered energy (e.g., for defibrillation shocks), one or more connector for low powered energy (e.g., for pacing), and / or one or more connector for sensor signals. In some embodiments, the plugs, connectors, and / or the like coupling the ICD generator 120 to the ICD lead 140 can include banana plugs, DF-4 connectors, DF-1 connectors, IS-1 connectors, IS-4 connectors, and / or the like. In some embodiments, the ICD lead 140 can be coupled to the ICD generator 120 permanently and / or semi permanently and may not use such plugs, connectors, and / or the like. In some embodiments, the ICD generator 120 can send treatment to only a subset of the connectors, based on the type of treatment determined by the processor 122. For example, if the processor 122 determines that pacing treatment is desired, the ICD generator 120 can be configured to send treatment via the connectors that are associated with pacing electrodes of the ICD lead 140.

[0059] The ICD lead 140 additionally includes shock coil(s) 144, electrode(s) 146, and, in some embodiments, a stabilizer 148. The shock coil(s) and the electrode(s) 146 include shocking elements for delivering treatment (e.g., including energy from the ICD generator 120)to the heart H of the patient P. In some embodiments, the ICD lead 140 is positioned in the substernal space and / or anterior mediastinum in the patient P. In some embodiments, the ICD lead 140 or at least a portion thereof is positioned in contact with, adjacent to, and / or otherwise in close proximity to the fibrous pericardium of the heart H. In some embodiments, the ICD lead 140 and / or portion(s) thereof can be positioned endocardial, epicardial, or under the sternum.

[0060] In some embodiments, the ICD lead 140 can be designed and / or formed to use, traverse, and / or fill (or at least substantially use, traverse, and / or fill) at least a portion of the volume between the sternum and the pericardium of the heart H. For example, the ICD lead 140 can have a three-dimensional (3-D) spatial structure (e.g., an anterior mediastinum traversal structure) allowing the ICD lead 140 to traverse the anterior mediastinal space (or at least a portion of the space or volume between the sternum and the fibrous pericardium of the heart H). In general, the term “3-D spatial structure” can be and / or can refer to any structure, shape, feature, etc. configured to allow for the ICD lead 140 to be disposed in and span across (or substantially span across) the anterior mediastinum while desirably having one or more portions positioned against the sternum and one or more portions positioned against an exterior surface of the heart. In some embodiments, the 3-D spatial structure can be and / or can one or more portions that extend radially away from a central axis of the ICD lead 140. The 3-D spatial structure can be and / or can include a portion of the ICD lead 140 that is looped, zig-zagged, waved, non-linear, or non-coaxial relative to an axis extending through the ICD lead 140 (e.g., a longitudinal or central axis of the ICD lead 140, an axis extending through the shock coil portion of the ICD lead 140, and / or the like).

[0061] For example, when implanted, the longitudinal axis of the ICD lead 140 can extend through a sternal portion of the ICD lead 140 that is disposed along a posterior surface of the sternum of the patient and one or more radial extensions, loops, etc. can be configured to extend radially outwardly toward the heart H. In some embodiments, the ICD lead 140 is sized and configured so that the portions of the ICD lead 140 along the longitudinal axis are positioned at or along the sternum while the one or more radial extensions, loops, etc. contact(s) the heart H. Alternatively, the ICD lead 140 can have a longitudinal or central axis, with each of the sternal portions and the heart wall portions extending radially outwardly from the longitudinal or central axis. In some embodiments, the sternal portions of the ICD lead 140 can be and / or can include the shock coil(s) 144, while the radial extensions, loops, etc. can include the electrode(s) 146. Such an arrangement can maintain the electrode(s) 146 in contact with or inrelative close proximity to an external surface of the heart (e.g., the fibrous pericardium), which in some instances, can reduce pacing thresholds.

[0062] While the ICD lead 140 is described as having an axis that extends through a portion of the ICD lead 140 (e.g., a sternal portion) and having extensions that extend from the axis in at least one direction (e.g., radially), the ICD lead 140 can include a 3-D spatial structure that is not limited to such a form. For example, the ICD lead 140 is a relatively thin extension similar to a wire that, without being arranged to include the 3-D spatial structure, would not span the anterior mediastinal space between the posterior surface of the sternum and an exterior surface of the heart. Thus, the ICD lead 140 can be configured to include and / or form any suitable 3-D spatial structure such that one or more portions of the ICD lead 140 are in contact with or in relatively close proximity to the sternum (e.g., one or more sternal portions) and one or more portions of the ICD lead 140 are in contact with or in relatively close proximity to the exterior surface of the heart (e.g., one or more heart wall portions).

[0063] Delivery of the ICD lead 140 into a desirable location in the anatomy, such as the substernal space of the patient, is further described in International P.C.T. Patent Application No. PCT / US2025 / 013826, entitled, “Systems and Methods for Delivery of a Lead of an Implantable Cardioverter Defibrillator,” filed January 31, 2025, the disclosure of which is incorporated herein by reference in its entirety. In some embodiments, the ICD lead 140 can be reconfigurable between a configuration for delivery and a configuration for positioning the ICD lead 140 in the substernal space. For example, the ICD lead 140 can be at least partially formed of a flexible material to allow for reconfiguration.

[0064] In some embodiments, the ICD lead 140 can include one or more sternal portions configured to engage, contact, and / or otherwise be in close proximity to the posterior side of the sternum of the patient P. Engaging the sternum of the patient P allows for the ICD lead 140 to maintain stability in the substernal space. In some embodiments, the sternal portions can be linear and / or substantially linear. In some embodiments, the sternal portions can include slight curves and / or the like to match the shape of the sternum. For example, the sternal portions can be shaped, sized, and / or configured based on a patient’s specific anatomy (e.g., determined using scans, imaging, modeling, and / or the like). In some embodiments, the sternal portions can be relatively stiff to provide support for the ICD lead 140, when implanted. In some embodiments, the sternal portions can be relatively pliable or flexible to allow for motion of the ICD lead 140 during movement of patient P (e.g., during activity, cardiac activity, and / or respiration). In some embodiments, the shock coil(s) 144 can be on and / or along the sternalportions of the ICD lead 140. In some embodiments, ICD lead 140 can include more than one shock coil 144. For example, the ICD lead 140 can include a shock coil 144 on each portion of the ICD lead 140 that is separated from the heart wall by a predetermined distance. In some embodiments, the predetermined distance may be a threshold distance and / or range that is desirable to deliver defibrillation shocks.

[0065] In some embodiments, the ICD lead 140 can include one or more heart wall portions configured to engage, contact, and / or otherwise be in close proximity to the heart wall of the patient. In some embodiments, the heart wall portions are configured to engage, contact, and / or otherwise be in close proximity to the fibrous pericardium of the heart. Engaging the heart wall allows for the ICD lead to engage pacing and / or sensing in a desirable location along the heart. In some embodiments, the heart wall portions can be one or more features (e.g., loops, branches, etc.) distal to and / or between the sternal portions. In some embodiments, the heart wall portions and the sternal wall portions are linearly and / or sequentially arranged along a length of the ICD lead 140. In some embodiments, the heart wall portions and the sternal wall portions can be on separate branches and / or can be in separate planes of the ICD lead 140 (e.g., the heart wall portions and the sternal wall portions are not co-planar and / or not co-axial).

[0066] These features can be configured to provide a portion of the ICD lead 140 that can engage the heart wall while still having the sternal portions engage the sternum and provide stability and / or support for the ICD lead 140. In some embodiments, the ICD lead 140 can include features of various shapes and / or sizes to match the shape of the heart wall or the anterior mediastinal space. For example, the ICD lead 140 can have a 3-D spatial structure that allows the heart wall portions to engage (or substantially engage) the heart wall and that allows the sternal portions to engage (or substantially engage) the sternum. In some embodiments, such features can include one or more loops, helixes, curves, bends, branches, and / or any other suitable 3D structure or shape. In some embodiments, the ICD lead 140 includes a first smaller loop and a second larger loop that can at least partially correspond to the anatomy and / or constraints of the anterior mediastinum. In some embodiments, the features of the ICD lead 140 can be formed to position the ICD lead 140 (or a portion of the ICD lead 140) in a desired position. In some embodiments, the desired position of the ICD lead 140 is customized to the anatomy of the patient P. In some embodiments, the ICD lead 140 (or at least the heart wall portions thereof) can be pliable and / or flexible to allow for the heart wall portions to move with the heart H of the patient P and / or with the activity of the patient, thus allowing for the heart wall portions to maintain engagement or substantial engagement with the heart wall.Furthermore, the positioning of the ICD lead 140 allows for the ICD lead 140 to move in multiple directions and absorb and / or move with the motion of the heart H.

[0067] In some embodiments, the heart wall portions of the ICD lead 140 can include one or more electrode(s) 146. The electrodes can be positioned, for example, on the portion of the heart wall portions that directly engage the heart wall. The electrode(s) 146 can includes sensing electrodes and / or pacing electrodes. In some embodiments, the electrode(s) 146 can serve as both sensing and pacing electrodes during operation. For example, during data collection, the electrode(s) 146 can serve as sensing electrodes and during treatment, the electrode(s) 136 can serve as pacing electrodes. In some embodiments, a portion of the electrode(s) 146 can be treatment electrodes and a portion of the electrode(s) 136 can be pacing electrodes.

[0068] Sensing electrodes of the electrode(s) 146 (e.g., sensing capabilities) can be configured to sense signal associated with the heart H of the patient P. For example, the electrode(s) 146 can be configured to sense or measure cardiac electrical signals radiating from the fibrous pericardium, allowing the electrode(s) 146 and / or the processor 122 of the ICD generator 120 to determine heart rate, voltage, P wave, QRS morphology, ST segment, T wave, ECG signals, and / or the like. In some embodiments, the electrode(s) 146 can include multiple sensing electrodes that are configured to measure the same characteristic of the patient and / or can include multiple sensing electrodes that can be configured to measure more than one characteristic of the patient. In some embodiments, measuring the same characteristic using multiple sensing electrodes can provide redundancy in the event of failure or as a way to corroborate and / or verify the accuracy of the signals. The electrode(s) 146 can be calibrated based on one or more known measurement(s) of patient characteristic(s). Calibration can include calibrating the output of the electrode(s) 146 to align with known measurements of patient characteristics. For example, a cardiac electrical signal sensor can sense cardiac electrical signals radiating from the heart H, which in turn, can be used to measure and / or infer, for example, cardiac rate. In some instances, cardiac rate measurements, inferences, and / or determinations can be calibrated based on comparing and adjusting the sensor output to an external or endocardial measuring device.

[0069] Pacing electrodes of the electrode(s) 146 (e.g., pacing capabilities) can be configured to provide pacing energy (e.g., anti-tachycardia pacing, bradycardia pacing, post-shock pacing, and / or the like) to the fibrous pericardium of the heart H. The positioning of the electrode(s) 146 directly on the heart wall allows for the pacing threshold energy to be lower than leadspositioned in the anterior mediastinal space, thus allowing the ICD lead 140 to be used for more patients with high sensitivity to pacing thresholds as pacing thresholds that are higher than desired could result in inconsistent pacing, intolerable sensations to the patient during pacing, or non-use of pacing that increases probability of undesirable health events and / or undesirable shocks. During operation, since they are lower energy electrodes, the electrode(s) 146 can switch between operating as a sensing electrode and as a pacing electrode, thus reducing both complexity and bulk in the ICD lead 140, which can reduce post-operative complications after implantation. While direct contact with the heart wall is desirable, it should be understood that practical considerations and / or limitations may result in the electrodes(s) 146 being in close proximity to the heart wall, but not in direct contact. For example, the anterior mediastinum is a dynamic environment that can cause slight movement of the ICD lead 140 relative to the heart H. Thus, while it is desirable for the electrodes 146 to be in contact with the heart wall, slight relative movement is contemplated and / or understood. Moreover, the design of the ICD lead 140 is intended to minimize such movement so that the electrode(s) 146 can remain or substantially remain in contact with and / or in close proximity to the heart wall.

[0070] In some embodiments, including multiple electrodes can be beneficial for reducing pacing thresholds. For example, a pacing threshold can be determined independently for each electrode 146 and the electrode with the lowest pacing threshold can be determined by the ICD generator 120 to receive and deliver the treatment energy, while the other electrode 146, for example, acts as a return path for the energy (i.e., electrical current). Accordingly, the pacing threshold for a patient may be reduced. In some implementation, variability between the pacing thresholds for the electrodes 146 may be based, at least in part, on a relative placement of the electrode, anatomic constraints and / or features, and / or the like.

[0071] In some embodiments, the stabilizer 148 is a portion of the ICD lead 140 that can provide additional stability during operation. For example, the stabilizer 148 can be a curved portion (e.g., helix, loop, curve, hook, etc.) that is at the distal end of the ICD lead 140. The stabilizer 148 can engage the sternum at the sternal angle and provides additional stability for maintaining ICD lead 140 position in the substernal space throughout the life of the lead. In some embodiments, the stabilizer 148 can be a rib, a coiled portion, and / or the like anywhere along the length of the ICD lead 140 to provide additional stability to the ICD lead 140. In some embodiments, the stabilizer 148 is optional. For example, the sternal portions and / or the heart wall portions can include features and / or can be formed in a shape that provides adequate stability for the ICD lead 140 such that the ICD lead 140 can be maintained or substantiallymaintained in a desired position in the substemal space for a desired amount of time. As described above, such a desired position can be one in which the electrode(s) 146 and / or heart wall portion of the ICD lead 140 is in contact with or is otherwise in close proximity to the fibrous pericardium of the heart H.

[0072] In some embodiments, the stabilizer 148 and / or other portions of the ICD lead 140 can include portions with varied flexibility that can allow for the ICD lead 140 into a desired location and / or to position the ICD lead 140 in the substemal space. In some embodiments, the stabilizer 148 and / or other portions of the ICD lead 140 can be configured to substantially change the shape of and / or provide rigidity to the ICD lead 140. For example, a first configuration of the stabilizer 148 can be substantially straight for delivering the ICD lead 140 to a desired position within the patient P and a second configuration of the stabilizer 148 can be for shaping the features of the ICD lead 140 and for providing stability within the substemal space, as described above.

[0073] The sensor(s) 150 can be sensors configured to measure characteristics associated with the patient. More specifically, the sensor(s) 150 or at least a portion thereof can be sensors configured to measure characteristics associated with the heart H of the patient P. For example, the sensor(s) 150 can be configured to measure electrical signals and / or mechanical signals radiating from the heart. In some embodiments, one or more sensor(s) 150 can be configured to measure, detect, and / or sense mechanical signals within the anterior mediastinum (e.g., mechanical signals associated with respiration, hemodynamic output of the heart, and / or any other portion or function of the body of the patient P). For example, in some embodiments, the one or more sensor(s) 150 can be configured to measure, detect, and / or sense a pressure or a change in pressure in the anterior mediastinum. In some embodiments, the outputs of the sensor(s) 150 can be calibrated based on the patient P, the position in the body of the patient P, and / or the like. For example, the sensor(s) 150 can be calibrated based on one or more known measurement(s) of patient characteristic(s). Calibration can include calibrating the output of the sensor(s) 150 to align with known measurements of patient characteristics. For example, a cardiac electrical signal sensor used to measure, for example, cardiac rate can be calibrated based on comparing and adjusting the sensor output to an external cardiac rate measuring device. In some embodiments, the sensor(s) 150 can be a portion of the ICD 110. For example, the sensor(s) 150 can be additional sensors configured to communicate directly with the ICD generator 120. As another example, the sensor(s) 150 can be sensors configured to communicate with the ICD lead 140. As yet another example, the sensor(s) 150 can be a portionof the ICD lead 140. For example, the sensor(s) 150 can be coupled to the ICD lead 140 and / or be a portion of the ICD lead 140. In some embodiments, the sensor(s) 150 can be and / or can include redundant sensors for the sensors otherwise incorporated into and / or that are a part of the ICD lead 140. In some embodiments, the sensor(s) 150 can measure characteristics not sensed by the ICD lead 140. In some embodiments, such as when the ICD lead 140 includes integrated or incorporated sensors configured to measure desired characteristics, the sensor(s) 150 (e.g., separate from the ICD lead 140) are optional.

[0074] As described in detail in the ‘544 application, the ‘740 PCT, and / or the ‘954 PCT, the sensors included in and / or used in conjunction with the ICD lead 140 can be configured to sense, detect, measure, and / or otherwise collect data associated with the heart H and / or other portions or functions of the patient P. For example, one or more sensors (e.g., one or more of the electrode(s) 146 and / or any other suitable sensor) can be used to detect and / or sense cardiac electrical signals radiating from the heart H. The cardiac electrical signals can be and / or can be used as ECG signals allowing the ICD generator 120 (and / or the processor 122 thereof) to determine, detect, define, and / or infer the electrical functioning of the heart H. In some instances, the processor 122 can be configured to execute instructions (stored in the memory 124) that cause the processor 122 to analyze the cardiac electrical signals and determine a cardiac status or a suspected cardiac status based on the cardiac electrical signals.

[0075] The ICD system 100 also includes one or more additional sensors (incorporated into and / or otherwise used in conjunction with) the ICD lead 140 configured and / or used to detect and / or sense mechanical signals present in the anterior mediastinum and / or substernal space. In some instances, for example, the additional sensor(s) can be configured to detect and / or sense mechanical signals such as changes in pressure in the anterior mediastinum as a result of the beating of the heart H and / or respiration (inflation / deflation of the lungs). Alternatively, the mechanical signals can be associated with characteristic such as position, acceleration, and / or the like.

[0076] The ICD generator 120 and / or the processor 122 thereof can be configured to use the data associated with the electrical signals (e.g., radiating from the heart H) and the data associated with the mechanical signals (e.g., mechanical signals present in the anterior mediastinum) to determine a status of the heart H. As described above, in some instances, the processor 122 can be configured to determine and / or define a suspected or assumed cardiac status based on the data associated with the cardiac electrical signals. In addition, the processor 122 can be configured to confirm and / or verify the suspected and / or assumed cardiac statusbased at least in part on a correlation between the electrical signal data and the mechanical signal data. For example, a relatively high degree of correlation between the electrical signal data and the mechanical signal data can be confirmation of the suspected and / or assumed cardiac status because the mechanical functioning of the heart H corresponds to and / or is correlated with the electrical functioning of the heart H. Conversely, the processor 122 can be configured to determine that the suspected and / or assumed cardiac status based on the electrical signal data alone is not the actual cardiac status when there is a relatively low degree of correlation between the electrical signal data and the mechanical signal data. In some implementations, correlating data associated with two different signals and / or otherwise using additional data to confirm and / or verify an implied, suspected, and / or assumed cardiac state (e.g., based on a single data source like cardiac electrical signals) can reduce and / or limit inappropriate or undesired shock treatments delivered to the heart H of the patient P, as described in detail in the ‘544 application, the ‘740 PCT, and / or the ‘954 PCT.

[0077] FIG. 1C schematically depicts a treatment system 101 including an ICD 110 engaging a patient P. While the treatment system 101 is structurally and / or functionally similar to the ICD system 100 of FIG. IB, the treatment system 101 includes an ICD 110 that includes a substernal lead 140a and an epicardial lead 140bb that are functionally and / or structurally similar to the ICD lead 140.

[0078] In some embodiments, the ICD 110 can include any number of substernal leads 140a. In some embodiments, the substernal lead(s) 140a is / are positioned under the sternum in the substernal space and / or anterior mediastinum of the patient P. In some embodiments, the substernal lead 140a (referred to in the singular for simplicity) is positioned in contact with, adjacent to, and / or otherwise in close proximity to the fibrous pericardium of the heart H. In some embodiments, the substernal lead 140a can be designed and / or formed to use, traverse, and / or fill (or at least substantially use, traverse, and / or fill) at least a portion of the volume between the sternum and the pericardium of the heart H (e.g., the substernal space and / or the anterior mediastinum).

[0079] The substernal lead 140a is operatively coupled to the generator 120 via any suitable connector. In some embodiments, the substernal lead 140a can extend away from the generator 120 via a conduit that includes a signal / power carrying wire (e.g., the lead interface 130 and / or the generator interface 142). The substernal lead 140a is configured to deliver treatment to the heart H of the patient P. The substernal lead 140a can include shocking elements for delivering treatment (e.g., including energy from the generator) to the heart H of the patient P. In someembodiments, the substernal lead 140a can further include any number of sensors or the like configured to sense and / or collect cardiac signals (e.g., cardiac electrical signals and / or cardiac mechanical signals). In some embodiments, the substernal lead(s) can be similar to and / or substantially the same as the substernal leads described in the ‘544 application, the ‘740 PCT, and / or the ‘954 PCT.

[0080] The ICD 110 can include any number of epicardial leads 140b. The epicardial lead(s) 140b is / are operatively coupled to the generator 120 via any suitable connector(s) (e.g., interface, a conduit that includes a signal / power carrying wire, etc.) such as the lead interface 130 and / or the generator interface 142. The epicardial lead 140b (referred to in the singular for simplicity) is configured to deliver treatment energy at, for example, a lower pacing threshold than the substernal lead 140a. In some embodiments, the epicardial lead 140b is configured to operate as a left ventricular lead (e.g., placed in the epicardium of the left ventricle of the heart H) and / or a right ventricular lead (e.g., placed in the epicardium of the right ventricle of the heart H). In some embodiments, the epicardial lead 140b may be placed in the pericardium or pericardial cavity. The epicardial lead 140b may be placed and / or implanted in the epicardium using imaging (e.g., fluoroscopy) to deliver the lead to a desired location in the heart H. In some embodiments, the epicardial lead 140b may include one or more features for securing the lead in the epicardial tissue of the heart H. For example, the epicardial lead 140b can include a helix at the superior or distal end to maintain stability. In some embodiments, the epicardial lead 140b can include a stabilizer as described above in reference to stabilizer 148. In some embodiments, the epicardial lead 140b is configured to be biocompatible with low friction to allow for movement with the heart.

[0081] In some embodiments, the epicardial lead 140b is a primary treatment lead for the ICD 110 or at least for pacing provided by the ICD 110. In some embodiments, the epicardial lead 140b is a backup and / or secondary lead for when it is undesirable to use the substernal lead 140a. For example, in some implementations, it may be desirable to deliver treatment energy (e.g., shock therapy and / or pacing) via the substernal lead 140a and thus, the substernal lead 140a can be considered the default lead for delivering treatment energy to the heart H. In some instances, however, physiological and / or pathophysiological characteristics may be such that the pacing thresholds associated with the use of the substernal lead 140a result in discomfort and / or other adverse effects for the patient. Accordingly, in such instances, the epicardial lead 140b can be used to provide pacing at lower energy thresholds. In some embodiments, the epicardial lead 140b is configured to deliver bipolar or unipolar pacing.

[0082] The epicardial lead 140b can include electrodes for sensing characteristics and / or for applying treatment (e.g., functionally and / or structurally similar to the electrode(s) 146). The electrodes are configured to engage epicardial tissue and to deliver and / or apply treatment energy at lower energy levels than the substemal lead 140a. For example, the electrodes of the epicardial lead 140b can apply and / or deliver low-power treatment energy (received from the generator 120) used for any suitable type of cardiac pacing. The implantation of the epicardial lead 140b in the epicardial tissue can allow, for example, lower pacing thresholds than the pacing thresholds otherwise associated with using the substernal lead 140a for cardiac pacing. In some embodiments, the epicardial lead 140b is configured to be minimally invasive and thin (e.g., thinner than 4 French, etc.), which can allow for relatively easy implantation and can avoid undesirable tissue damage. Outside of the epicardium, the epicardial lead 140b can include an insulated portion that does not allow for treatment energy to applied to the pericardium or outside of the pericardium, thus protecting the patient P. The epicardial lead(s) 140, in portions with or without insulation, is / are configured to be flexible to allow for movement with the heart during the cardiac cycle.

[0083] While the embodiment shown in FIG. 1C has been described as including the epicardial lead(s) 140 configured to be implanted in epicardial tissue, it should be understood that a treatment system and / or ICD may include, for example, one or more leads configured to be implanted in other cardiac tissue such as, for example, the myocardium. In such embodiments, including myocardial leads may allow for further reductions in a size of the lead as we all further reductions in, for example, pacing thresholds. In some embodiments, a treatment system may include one or more leads configured to be implanted in, for example, pericardial cavity (e.g., below the fibrous pericardium but outside the epicardium). In some instances, leads in the pericardial cavity can allow for lower pacing thresholds (e.g., relative to leads in the substernal space or otherwise positioned outside the heart (exocardial)), while avoiding potential patient complications associated with implanting leads in the epicardium.

[0084] FIG. 2 schematically depicts an ICD lead 240 (e.g., structurally and / or functionally similar to the ICD lead 140 of FIGS. 1B-1C) engaging and / or substantially engaging with the heart H of a patient P, according to an embodiment. The ICD lead 240 is configured to receive treatment energy from a treatment generator, such as the ICD generator 120 of FIGS. 1B-1C, and / or other similar power source. The ICD lead 240 is configured to direct the treatment energy to the heart H of the patient P to provide shock treatment such as defibrillation shocks and / or cardiac pacing. As seen in FIG. 2, the ICD lead 240 is implanted in a substernal spacebetween a sternum S and a heart H of the patient P (e.g., the anterior mediastinum). The ICD lead 240 includes a generator interface 242 (e.g., structurally and / or functionally similar to the generator interface 142 of FIGS. 1B-1C), one or more shock coils 244a, 244b, 244c (e.g., each functionally and / or structurally similar to the shock coil(s) 144 of FIGS. 1B-1C), one or more electrodes 246, 246b (e.g., each functionally and / or structurally similar to the electrodes 146 of FIGS. 1B-1C), and an optional stabilizer 248 (e.g., functionally and / or structurally similar to the stabilizer 148 of FIGS. 1B-1C). In some embodiments, the ICD lead 240 can include additional or fewer shock coils 244a, 244b, 244c than shown in FIG. 2. In some embodiments, the ICD lead 240 can include additional or fewer electrodes 246a, 246b than shown in FIG. 2.

[0085] The generator interface 242 is configured to couple to a generator or other power source to allow for treatment energy to be delivered to the ICD lead 240. The generator interface 242 is operatively coupled to the shock coils 244a, 244b, 244c and to the electrodes 246a, 246b to deliver the associated energy to the desired location of the heart H. The generator interface 242 can include one connector or can include multiple connectors, each connector associated with one of the shock coils 244a, 244b, 244c or one of the electrodes 246a, 246b. For example, a first connector can be operatively coupled to the shock coil 244a, a second connector can be operatively coupled to the electrode 246a, a third connector can be operatively coupled to the shock coil 244b, a fourth connector can be operatively coupled to the electrode 246b, and a fifth connector can be operatively coupled to the shock coil 244c.

[0086] The ICD lead 240 includes one or more sternal portions configured to engage and / or substantially engage the sternum S of the patient P. The sternal portions include the shock coils 244a, 244b, 244c configured to provide defibrillation shocks to the heart H. In some embodiments, each shock coil 244a, 244b, 244c is included in a different (e.g., noncontiguous) sternal portion. As the sternal portions engage the sternum S, so do the shock coils 244b, thus establishing a spacing between the shock coils 244a, 244b, 244c and the heart H. The spacing is acceptable as the shock coils 244a, 244b, 244c are configured to provide high energy defibrillation shocks that are not dependent on a position of the shock coils 244a, 244b, 244c in the substernal space.

[0087] The ICD lead 240 includes one or more heart wall portion configured to engage and / or substantially engage the heart H at the heart wall H. The heart wall portions include the electrodes 246a, 246b, which are configured to provide pacing energy to the heart wall of the heart H and / or measure characteristics associated with the heart H. The heart wall portions engage, contact, and / or are otherwise in close proximity to the heart wall to so that theelectrodes 246a, 246b can provide desirable pacing treatment with relatively low pacing thresholds and / or can measure characteristics of the heart H with a desired degree of fidelity (e.g., low noise, etc.). In some embodiments, the electrodes 246a, 246b are sensing electrodes. In some embodiments, the electrodes 246a, 246b are pacing electrodes. In some embodiments, the electrodes 246a, 246b operate as both sensing electrodes and treatment electrodes. In some embodiments, one electrode of the electrodes 246a, 246b operates as a sensing electrode and the other electrode of the electrodes 246a, 246b operates as a pacing electrode. The sternal portions and the heart wall portions of the ICD lead 240 are arranged in series to simplify the structure and delivery of the ICD lead 240.

[0088] In the embodiment shown in the FIG. 2, the ICD lead 240 includes a first sternal portion (e.g., a proximal sternal portion) and including the shock coil 244a, a second sternal portion (e.g., a medial sternal portion) including the shock coil 244b, and a third sternal portion (e.g., a distal sternal portion) including the shock coil 244c and the stabilizer 248. In some embodiments, the second sternal portion and the third sternal portion are optional. In some embodiments, the sternal portions can be disposed and / or arranged sequentially in or along a common plane. For example, the sternal portions can be co-axial and / or substantially co-axial. In other embodiments, the sternal portions can be misaligned and / or otherwise disposed in any suitable arrangement (e.g., an arrangement based at least in part by the anterior mediastinal space).

[0089] The ICD lead 240 further includes a first heart wall portion (e.g., a proximal heart wall portion) including the electrode 246a and a second heart wall portion (e.g., a distal heart wall portion) including the electrode 246b. In some embodiments, the second heart wall portion is optional. The ICD lead 240 is configured such that the first sternal portion is proximal to the first heart wall portion; the first heart wall portion is proximal to the second sternal portion; the second sternal portion is proximal to the second heart wall portion; and the second heart wall portion is proximal to the third sternal portion. In some embodiments, the ICD lead 240 can include a different arrangement of sternal portions and heart wall portions. For example, the ICD lead 240 can include two heart wall portions proximal to a sternal portion, one heart wall portion proximal to a sternal portion, two heart wall portions between two sternal portions, and / or the like. The stabilizer 248, when included in the ICD lead 240, is at the distal end of the ICD lead 240. In some embodiments, the stabilizer 248 engages the sternum at the sternal angle to provide the ICD lead 240 with additional support in the substernal space.

[0090] As shown in FIG. 2, the heart wall portions can be at least partially misaligned relative to the sternal portions. For example, the ICD lead 240 can have and / or define a 3-D spatial structure that is based at least in part on a size and / or shape of the anterior mediastinum of the patient. In some embodiments, the ICD lead 240 can form and / or can include one or more radial extensions, loops, helixes, curves, bends, branches, and / or any other suitable 3D structure or shape that offset at least the heart wall portions in a radial direction. In some embodiments, and as shown in FIG. 2, the sternal portions may be disposed along an axis A (e.g., a longitudinal or central axis extending through the sternal portions). In some embodiments, the heart wall portions may be configured to extend radially away from the axis A. In some embodiments, the distance(s) that the heart wall portions extend away from the axis A are associated with the anatomy of the anterior mediastinum (e.g., a distance between a posterior surface of the sternum and an external surface of the heart such as the fibrous pericardium). In some embodiments, the sternal portions and the heart wall portions can extend radially from a central axis associated with the ICD lead 240 (e.g., similar to a spiral or helix structure).

[0091] Moreover, the heart wall portions can be arranged such that the electrodes 246a, 246b are disposed at or along an outer or substantially outermost position of the heart wall portions. For example, the heart wall portions can be and / or can have a 3-D shape such as a loop or helix, and the electrodes 246a, 246b can be included at a position that is spaced apart from the sternal portions (e.g., at a furthest distance or substantially furthest distance). Thus, the heart wall portions and the sternal wall portions can be on separate branches and / or can be in separate planes of the ICD lead 240 (e.g., the heart wall portions and the sternal wall portions are not co-planar and / or not co-axial). As described above with reference to the ICD lead 140, the 3- D spatial structure of the ICD lead 240 allows the lead to traverse the anterior mediastinal space such that the heart wall portions engage, contact, and / or are otherwise in close proximity to the heart wall, while the sternal portions engage, contact, and / or are otherwise in close proximity to a posterior surface of the sternum.

[0092] While the ICD lead 240 is described above as including the electrodes 246a, 246b that can be used as sensing electrodes, pacing electrodes, or both sensing and pacing electrodes, in some embodiments, the ICD lead 240 can include and / or can be coupled to any number of additional or other sensors. For example, as shown in FIG. 2, the ICD lead 240 can include and / or can be coupled to one or more sensor 250 configured to detect and / or sense mechanical signals (e.g., pressure) in the anterior mediastinum. In such embodiments, the sensing electrodes (e.g., the electrodes 246a and / or 246b, or portions thereof) can be configured todetect and / or sense electrical signals radiating from the heart H, while the sensor(s) 250 included in and / or coupled to the ICD lead 240 is / are configured to sense and / or detect mechanical signals in the anterior mediastinum such as changes in pressure as a result of the mechanical functioning (beating) of the heart H, respiration, and / or the like. Such mechanical sensor(s) 250 can be integrated into a portion of the ICD lead 240 such as, for example, the stabilizer 248 and / or any other suitable portion of the lead body 241 (e.g., a distal tip or end of the stabilizer 248). In some embodiments, such mechanical sensor(s) 250 can be remote from the ICD lead 240 and in communication with, for example, the generator interface 242. Alternatively, such mechanical sensor(s) 250 can be in communication with the ICD generator independent of the ICD lead 240.

[0093] In some embodiments, during treatment delivery, an electrical path can be formed between the shock coils 244 and / or the electrodes 246. For example, the electrical current from the ICD generated can be delivered by one or more electrode 246, pass through tissue (e.g., cardiac tissue), and then returned by one or more of the shock coils 244. As another example, electrical current can be delivered by one electrode 246, pass through tissue (e.g., cardiac tissue), and then returned by a different electrode 246. In some embodiments, the ICD lead 240 can include additional electrodes, coils, conductors, and / or the like that may be configured to return electrical current to form an electrical path during treatment (e.g., pacing treatment).

[0094] FIG. 3 depicts an ICD lead 340 (e.g., structurally and / or functionally similar to the ICD lead 140 of FIGS. 1B-1C and / or the ICD lead 240 of FIG. 2), according to an embodiment. Similar to the other ICD leads described herein, the ICD lead 340 is configured to receive energy from a generator (e.g., functionally and / or structurally similar to the ICD generator 120 of FIGS. 1B-1C) and / or other power source. The ICD lead 340 is configured to be implanted in a substernal space and / or anterior mediastinum of a patient. The ICD lead 340 is configured to, when implanted, deliver treatment energy such as defibrillation energy and / or pacing energy. The ICD lead 340 includes a generator interface 342 (e.g., structurally and / or functionally similar to the generator interface 142 of FIGS. 1B-1C and / or the generator interface 242 of FIG. 2), a lead body 341, shock coils 344, 344b, 344c (e.g., functionally and / or structurally similar to the shock coil(s) 144 of FIGS. 1B-1C and / or the shock coils 244a, 244b, 244c of FIG. 2), electrodes 346a, 346b (e.g., functionally and / or structurally similar to the electrode(s) 146 of FIGS. 1B-1C and / or the electrodes 246a, 246b of FIG. 2), and a stabilizer 348 (e.g., functionally and / or structurally similar to the stabilizer 148 of FIGS. 1B-1C and / or the stabilizer 248 of FIG. 2).

[0095] The generator interface 342 is configured to couple to a treatment generator and / or other power source to operatively couple the ICD lead 340 so that the ICD lead 340 can receive treatment energy, sensing power, and sensing input (both mechanical and electrical sensing / sensor inputs). These connectors are configured to operatively couple the generator and / or power source to a different portion of the ICD lead 340. As shown, the lead body 341 can be arranged as tube that extends distally away from the generator interface 342. The lead body 341 may be relatively flexible so that the ICD lead 340 can be delivered to the desired destination in the substernal space. Moreover, the relative flexibility of the ICD lead 340 can provide a desired amount of compliance within the substernal space allowing the ICD lead 340 to bend, flex, and / or deflect in response to the functioning (beating) of the heart, respiration, and / or movement of the patient. The lead body 341 defines sternal portions 341a (e.g., structurally and / or functionally similar to any of the sternal portions described herein) and heart wall portions 341b (e.g., functionally and / or structurally similar to any of the heart wall portions described herein). The sternal portions 341a are substantially linear portions of the ICD lead 340 configured to engage the sternum while the heart wall portions 341b include and / or form looped portions of the ICD lead 340 that are configured to engage or substantially engage the heart wall when the ICD lead 340 is implanted in the substernal space. For example, in some embodiments, a size and / or shape of the looped portions can be based at least in part on a distance between a posterior surface of the sternum and a wall of the heart. In some embodiments, the looped portions can be slightly oversized relative to the distance between the sternum and the heart wall causing the looped portions to be slightly compressed or deformed when the ICD lead 340 is in the anterior mediastinum. Such an arrangement can result in a tension along at least a portion of the looped portion that can push the sternal portions of the ICD lead 340 toward the sternum and the heart wall portions of the ICD lead 340 toward the heart wall. In some embodiments, this can aid in maintaining the heart wall portions in contact with or in close proximity to the heart wall.

[0096] A portion (e.g., between about 1% and about 100%, inclusive of all ranges and values therebetween) of the sternal portions 341a can include the shock coils 344a, 344b, 344c. In some embodiments, the shock coils 344a, 344b, 344c can be grouped into separate sections. For example, the shock coils 344a, 344b, 344c can be grouped into a distal shock coil, a medial shock coil, and a proximal shock coil which can be controlled independently by the generator and / or other power source. The heart wall portions 341b include one or more electrode 346a, 346b on each looped portion. The electrodes 346a, 346b can be positioned along parts of theheart wall portions 34 la, 34 lb that are configured to contact, substantially contact, and / or otherwise be in close proximity to the heart wall. In some embodiments, each looped portion includes an electrode that operates both as a sensing electrode and as a pacing electrode. In some embodiments, one of the electrodes (e.g., the electrode 346a) is a sensing electrode and one of the electrodes (e.g., the electrode 346b) is a pacing electrode. At the distal end portion of the lead body 341, and thus the ICD lead 340, is the stabilizer 348. The stabilizer 348 is a coil, loop, and / or any other suitable shape / configuration configured to engage the sternal angle to maintain or substantially maintain a desired placement of at least a portion of the ICD lead 340 in the substemal space during the life of the ICD lead 340. The stabilizer 348 can reduce the likelihood or prevent rotation and / or translation of the ICD lead 340 in the substernal space while allowing for slight movements of the ICD lead 340 as a result of the functioning of the heart and / or activity of the patient.

[0097] Although not shown in FIG. 3, the ICD lead 340 can include and / or can be coupled to any number of sensors configured to detect and / or sense bio-signals (e.g., electrical signals radiating from the heart, mechanical signals present in the anterior mediastinum, and / or the like). For example, the ICD lead 340 can include and / or can be coupled to one or more sensor configured to detect and / or sense mechanical signals such as pressure or changes in pressure in the anterior mediastinum as a result of the mechanical functioning (beating) of the heart H, respiration, and / or the like. The sensor(s) can be integrated into any suitable portion of the ICD lead 340 such as, for example, the stabilizer 348 and / or any other suitable portion of the lead body 341.

[0098] FIGS. 4A-4C depict various views of an ICD lead 440 (e.g., structurally and / or functionally similar to the ICD lead 140 of FIGS. 1B-1C and / or ICD lead 240 of FIG. 2 and / or the ICD lead 340 of FIG. 3), according to an embodiment. Similar to the other ICD leads described herein, the ICD lead 440 is configured to receive energy from a generator (e.g., functionally and / or structurally similar to the ICD generator 120 of FIGS. 1B-1C) and / or other power source. The ICD lead 440 is configured to be implanted in a substernal space of a patient. The ICD lead 440 is configured to, when implanted, deliver treatment energy such as defibrillation energy and / or pacing energy. The ICD lead 440 includes a generator interface 442 (e.g., structurally and / or functionally similar to the generator interface 142 of FIGS. 1B- 1C and / or the generator interface 242 of FIG. 2 and / or the generator interface 342 of FIG. 3), a lead body 441 (e.g., functionally and / or structurally similar to the lead body 341 of FIG. 3), shock coils 444, 444b, 444c (e.g., functionally and / or structurally similar to the shock coil(s)144 of FIGS. 1B-1C and / or the shock coils 244a, 244b, 244c of FIG. 2 and / or the shock coils 344a, 344b, 344c of FIG. 3), electrodes 446a, 446b (e.g., functionally and / or structurally similar to the electrode(s) 146 of FIGS. 1B-1C and / or the electrodes 246a, 246b of FIG. 2 and / or the electrodes 346a, 346b of FIG. 3), and a stabilizer 348 (e.g., functionally and / or structurally similar to the stabilizer 148 of FIGS. 1B-1C and / or the stabilizer 248 of FIG. 2 and / or the stabilizer 348 of FIG. 3).

[0099] The generator interface 442 includes any number of connectors configured to couple to a corresponding port of a generator and / or power source. For example, the generator interface 442 can include a distal electrode connector 442a, a proximal electrode connector 442b, a proximal shock coil connector 442c, and a distal shock coil connector 442d. In some embodiments, the connectors 442 can be configured to be operably coupled to one or more of the shock coils 444 or electrodes 446 described herein. In some embodiments, the connectors442 can be any combination of type of connector. For example, the connectors 442 can include keying features, be different shapes, include colors, and / or the like to differentiate which electrode or coil the connectors 442 correspond to. In some embodiments, the generator interface 442 can be a single connector or plug. The generator interface 442 includes conduits443 leading away from the connectors 442 that operatively couple the connectors 442 to the corresponding electrodes 446a, 446b and shock coils 444a, 444b, 444c. In some embodiments, the connectors 442 are operatively coupled to one or more mechanical sensor(s), one or more electrical sensor(s), and the therapy delivering shock coils 444a, 444b, 444c and electrodes 446a, 446b. In some embodiments, the length DI of the conduits 443 is between about 5 centimeters (cm) and 15 cm. In some embodiments, the length DI is about 10 cm.

[0100] The conduits 443 continue though the lead body 441 which is formed as a tube to house the conduits. In some embodiments, the length of the lead body 441 is between about 30 cm and about 75 cm. In some embodiments, the length of the lead body 441 is about 50 cm. While the lead body 441 of FIGS. 4A-4C include a break, it should be appreciated that the length of the lead body 441 may be any length sufficient for connecting the substernal ICD lead 440 to a generator. The lead body 441 includes any number of sternal portions 441a. For example, FIGS. 4A-4C show the substernal portions 441a including a first sternal portion, a second sternal portion and a third sternal portion. The lead body 441 further includes any number of heart wall portions 441b. For example, FIGS. 4A and 4B show the heart wall portions 441b including a first heart wall portion and a second heart wall portion. The heart wall portionsform or can be formed by radial extensions, loops, bends, etc. that extend radially away from a longitudinal or central axis of the ICD lead 440, as described in detail above.

[0101] The first sternal portion of the sternal portions 441a includes a first shock coil 444a covering at least a portion of the first sternal portion. In some embodiments, the first shock coil 444a is disposed on a portion of the first sternal portion. For example, the first shock coil 444a can be disposed along the first sternal portion, such as between about 5% and about 100% of the first sternal portion, inclusive of all ranges and values therebetween. In some embodiments, the length D2 of the first shock coil 444a can be between about 0.5 cm and about 5 cm. In some embodiments, the length D2 is about 2 cm.

[0102] A first heart wall portion of the heart wall portions 441b is distal to the first sternal portion. The first heart wall portion includes the lead body 441 formed in a loop (e.g., spiral, etc.) with a first electrode 446a at an outer portion of the first heart wall portion (e.g., relative to the sternal portions 441a) that is configured to engage or substantially engage the heart wall. For example, the first electrode 446a can be at a midpoint of the loop and / or at a point radially furthest away from the first shock coil 444a. In some embodiments, the diameter of the loop is between about 0.5 cm and about 1.5 cm. In some embodiments, the diameter of the loop is about 1.0 cm. In some embodiments, the diameter of the loop is based at least in part on a distance between a posterior sternal wall and a wall of the heart for a given patient. In some embodiments, the loop extends a distance along an axial direction of the heart wall portion. That is to say, the loop may traverse a distance in an axial direction and thus, does not form or circumscribe, for example, a loop or circle in a single plane. In some embodiments, the first electrode 446a is configured to operate as a sensor electrode and / or as a pacing electrode. In some embodiments, the loop can be at least semi-flexible allowing the loop to move, flex, deform, and / or reconfigure in response to, for example, movement of the heart in the anterior mediastinum (e.g., movement associated with the heart beating), movement of the sternum (e.g., in response to respiration), and / or the like.

[0103] A second sternal portion of the sternal portions 441a is distal to the first heart wall portion. The second sternal portion includes a second shock coil 444b covering at least a portion of the second sternal portion. In some embodiments, the second shock coil 444b is disposed on a portion of the second sternal portion. For example, the second shock coil 444b can be disposed along the second sternal portion, such as between about 5% and about 100% of the second sternal portion, inclusive of all ranges and values therebetween. In some embodiments, a length D3 of the second shock coil 444b can be between about 0.5 cm and about 5 cm. Insome embodiments, the length D3 is about 1.0 cm. In some embodiments, the length D3 is based at least in part on a size of the heart for a given patient.

[0104] A second heart wall portion of the heart wall portions 441b is distal to the second sternal portion. The second heart wall portion includes the lead body 441 formed in a second loop (e.g., spiral, etc.) with a second electrode 446b at an outer portion of the second heart wall portion (e.g., relative to the sternal portions 441a) that is configured to engage or substantially engage the heart wall. For example, the second electrode 446b can be at a midpoint of the loop and / or at a point radially furthest away from the second shock coil 444b. In some embodiments, the diameter of the loop is between about 1 cm and about 3 cm. In some embodiments, the diameter of the loop is about 1.5 cm. In some embodiments, the loop extends a distance along an axial direction of the heart wall portion. That is to say, the loop may traverse a distance in an axial direction and thus, does not form or circumscribe, for example, a loop or circle in a single plane. In some embodiments, the second electrode 446b is configured to operate as a sensor electrode and / or as a pacing electrode. In some embodiments, the diameter of the loop is based at least in part on a distance between a posterior sternal wall and a wall of the heart for a given patient. In some embodiments, the diameter of the loop for the second heart wall portion is greater than the diameter of the loop for the first heart wall portion. As shown in FIG. 4B, in some embodiments, the distance D5 between the first electrode 446a and the second electrode 446b is between about 0.5 cm and about 4 cm. In some embodiments, the distance D5 is between about 0.5 cm and 2.5 cm. In some embodiments, the distance D5 is based at least in part on a size of the heart for a given patient. In some embodiments, the loop can be at least semi-flexible allowing the loop to move, flex, deform, and / or reconfigure in response to, for example, movement of the heart in the anterior mediastinum (e.g., movement associated with the heart beating), movement of the sternum (e.g., in response to respiration), and / or the like.

[0105] A third sternal portion of the sternal portions 441a is distal to the second heart wall portion. The third sternal portion includes a third shock coil 444c covering at least a portion of the third sternal portion. In some embodiments, the third shock coil 444c is disposed on a portion of the third sternal portion. For example, the third shock coil 444c can be disposed along the third sternal portion, such as between about 5% and about 100% of the third sternal portion, inclusive of all ranges and values therebetween. As shown in FIG. 4A, in some embodiments, a length D4 of the third shock coil 444c can be between about 5 cm and about 12 cm. In some embodiments, the length D4 is about 6 cm.

[0106] The stabilizer 448 is distal to the third sternal portion. FIG. 4C depicts a distal portion of the ICD lead 440 and specifically shows the stabilizer 448. The stabilizer 448 is a looped portion at the distal end of the lead body 441 that extends (or curves) away from or relative to an axis B defined by and / or extending through the sternal portions 441a of the ICD lead 440. In some embodiments, the stabilizer 448 includes a cap, a backfill, and / or other feature that closes the distal tip 449 of the lead body 441. In some embodiments the diameter of the stabilizer 448 is between about 1 cm and about 4 cm. In some embodiments, the diameter of the stabilizer 448 is about 2 cm.

[0107] Although not shown in FIGS. 4A-4C, in some embodiments, the ICD lead 440 can include one or more sensors, which can be coupled to and / or integrated with any suitable portion of the lead body 441. The one or more sensors can be configured to sense or detect one or more bio-signals present in the anterior mediastinum (e.g., electrical signals and / or mechanical signals). For example, in some embodiments, the lead body 441 can include a sensor that is coupled to and / or integrated with the distal tip 449 of the stabilizer 448. In such embodiments, the sensor can be configured to sense and / or detect mechanical signals such as, for example, pressure or changes in pressure within the anterior mediastinum. Moreover, the placement of the sensor at the distal tip 449 can reduce and / or limit undesirable contact between the sensor and tissue or bone that may interfere with the ability of the sensor to detect the biosignals.

[0108] Referring generally to FIGS. 5A, 5B and FIG. 6, various alternative embodiments of ICD leads are shown. The ICD leads shown may function similarly to the other ICD leads described herein. FIGS. 5A and 5B depict various view of an ICD lead 540 (e.g., structurally and / or functionally similar to the ICD lead 140 of FIGS. 1B-1C and / or the ICD lead 240 of FIG. 2), according to another embodiment. Similar to the ICD leads described herein, the ICD lead 540 is configured to deliver defibrillation treatment via a shock coil 544 (e.g., functionally and / or structurally similar to any of the shock coils described herein such as the shock coil(s) 144 of FIGS. 1B-1C and / or the shock coils 244a, 244b, 244c of FIG. 2) and pacing treatment via an electrode 546 (e.g., functionally and / or structurally similar to the electrode(s) 146 of FIGS. 1B-1C and / or the electrodes 246a, 246b of FIG. 2). The ICD lead 540 includes a lead body 541 (e.g., structurally and / or functionally similar to the ICD lead bodies described herein) formed as a tube and configured in a helix shape with a sternal portion including the shock coil 544 and a heart wall portion including the electrode 546. The helix shape of the ICD lead 540 can allow for desirable spacing between the shock coil 544 and the heart and desirable contactbetween the electrode 546 and the heart wall as the ICD lead 540 by wedging the ICD lead 540 between the heart and the sternum of the patient. Both the sternal portion and the heart wall portion of the ICD lead 540 are or form loops which can provide a desirable amount of stiffness while allowing for the electrode 546 to maintain contact with the heart wall during cardiac activity and / or patient activity.

[0109] FIG. 6 depicts an ICD lead 640 (e.g., structurally and / or functionally similar to the ICD lead 140 of FIGS. 1B-1C and / or the ICD lead 240 of FIG. 2), according to another embodiment. Similar to the ICD leads described herein, the ICD lead 640 is configured to deliver defibrillation treatment via shock coils 644a, 644b (e.g., functionally and / or structurally similar to any of the shock coils described herein such as the shock coil(s) 144 of FIGS. 1B-1C and / or the shock coils 244a, 244b, 244c of FIG. 2) and pacing treatment via an electrode 646 (e.g., functionally and / or structurally similar to the electrode(s) 146 of FIGS. 1B-1C and / or the electrodes 246a, 246b of FIG. 2). The ICD lead 640, unlike the ICD lead 340 of FIG. 3 and the ICD lead 440 of FIGS. 4A-4C includes only one looped portion of the body. The looped portion is between a first sternal portion with a first shock coil 644a and a second sternal portion with a second shock coil 644b. The looped portion includes one or more electrode 646 in or along a portion of the loop that is configured to contact the heart wall when the ICD lead 640 is implanted. In some embodiments, the loop can be size, shaped, contoured, etc. based at least in part on a size and / or shape of the heart wall.

[0110] FIG. 7 depicts an ICD lead 740 (e.g., structurally and / or functionally similar to any of the ICD leads 140, 240, 340, 440, 540, and / or 640 described herein) disposed in a packaging and / or kit, according to an embodiment. The ICD lead 740 can be flat packaged in a sterile package 760. The sterile package 760 can include a sterility marker 762 and an identifier 764 that can be used to determine if the sterile package 760 is sterilized and what type of ICD lead is in the sterile package 760, respectively. The ICD lead 740 may be restrained by tubing 766 that is configured to prevent the ICD lead 740 from unfurling in the sterile package 760.[OHl] FIG. 8 depicts graphs of sensor outputs, according to an embodiment. The sensor outputs can be outputs from a sensor on any of the ICD leads described herein. The “Top Trace - Surface ECG” graph shows a surface (e.g., a dermal surface or otherwise not inside the body) output of an electrocardiogram sensor while the “Bottom Trace - Sensor Output” graph shows the output of an ICD lead sensor electrode (e.g., functionally and / or structurally similar to any of the electrodes described herein). As seen in FIG. 8, the ICD lead sensor electrode data clearly shows patterns that are similar to the periodic patterns in the surface ECG data. The output ofthe ICD lead sensor electrode is a mechanical signal (e.g., a pressure change in a portion of the substernal space and / or anterior mediastinum due to heart beat and / or respiration) that includes periodic patterns corresponding to those in the surface ECG data as expected, which allows for the ECG data to be correlated with, compared to, and / or corroborated or verified by the mechanical signal. Moreover, since the mechanical signals are associated with the hemodynamic output of the heart (and / or otherwise can be used to calculate, determine, infer, predict, etc., the hemodynamic output of the heart), the mechanical signal data can be used to determine if the mechanical or hemodynamic condition or state corresponds with the condition or state indicated by, predicted by, and / or otherwise expected based on the ECG data. Thus, the mechanical signal can be used corroborate, verify, and / or validate a cardiac condition indicated and / or predicted by the ECG signal, thereby adding redundancy and / or verification that can reduce undesired or inappropriate treatment.

[0112] FIGS. 9A-9E depict various views of an ICD lead 940 according to another embodiment. The ICD lead 940 and / or portions thereof can be structurally and / or functionally similar to any of the ICD leads 140, 240, 340, and / or 440 (or corresponding portions thereof). Similar to the other ICD leads described herein, the ICD lead 940 is configured to receive energy from a generator (e.g., functionally and / or structurally similar to the ICD generator 120 of FIGS. 1B-1C) and / or other power source. The ICD lead 940 is configured to be implanted in a substernal space or anterior mediastinum of a patient. The ICD lead 940 is configured, when implanted, to deliver treatment energy such as defibrillation energy and / or pacing energy. The ICD lead 940 includes a generator interface 942 (e.g., structurally and / or functionally similar to any of the generator interfaces 142, 242, 342, and / or 442), a lead body 941 (e.g., functionally and / or structurally similar to the lead body 341 and / or 441), shock coils 944a, 944b, 944c (e.g., functionally and / or structurally similar to any of the shock coil(s) 144, 244a / 244b / 244c, 344a / 344b / 344c, and / or 444a / 444b / 444c), electrodes 946a, 946b (e.g., functionally and / or structurally similar to any of the electrode(s) 146, 246a / 246b, 346a / 346b, and / or 446a / 446b), sensors 950 (e.g., functionally and / or structurally similar to the sensor(s) 15 of FIG. 1A and / or sensor(s) 150 of FIGS. 1B-1C), and a stabilizer 948 (e.g., functionally and / or structurally similar to any of the stabilizers 148, 248, 348, and / or 448).

[0113] The generator interface 942 includes connectors 942a, 942b, and 942c. Each connector of the connectors 942a, 942b, 942c can be configured to operatively couple to a different portion of the ICD lead 940 and / or a different functional output of the generator. For example, a first connector 942a can be configured to operatively couple to the shock coils 944a, 944b,944c and / or the electrodes 946a, 946b, a second connector 942b can be configured to connect to a voltage source (e.g., about 1 volts (V) - 5V, inclusive of all ranges and values therebetween, etc.), and a third connector 942c can be configured to couple to a positive and negative lead of the sensors 950. In some embodiments, the first connector 942a can be configured to couple to all of the shock coils 944a, 944b, 944c together. In some embodiments, the first connector 942a can be configured to couple to the electrodes 946a, 946b independently to allow for independent control of treatment energy delivery to each electrode 946a, 946b (e.g., can include a number of conductors and / or circuits corresponding to the number of electrodes). The generator interface 942 defines a conduit length D6 between the distal end of the connectors 942a, 942b, 942c and the proximal end of the lead body 941. In some embodiments, the length D6 is between about 3 cm and about 10 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D6 is about 5 cm. In some embodiments, the length D6 is based at least in part on patient anatomy, size, etc.

[0114] The lead body 941, as seen in FIGS. 9A-9B, includes a bend 945 that is configured to provide the lead body 941 with strain relief. The bend 945 defines an angle Al. In some embodiments, the angle Al is between about 70 degrees and about 120 degrees, inclusive of all range and values therebetween. In some embodiments, the angle Al is about 90 degrees. In some embodiments, the bend 945 can be at least semi-flexible allowing the angle Al to be adjusted and / or set based at least in part on patient anatomy and / or other practical constraints. The lead body 941 defines a length D7 between the proximal end of the lead body 941 and the proximal end of the bend 945. In some embodiments, the length D7 is between about 15 cm and about 35 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D7 is about 25 cm. In some embodiments, the length D7 is based at least in part on patient anatomy, size, etc.

[0115] The lead body 941 and the other components of the ICD lead 940 define additional dimensions. For example, the lead body 941 defines a length D8 between a distal end of the bend 945 and a distal end of the ICD lead 940. In some embodiments, the length D8 is between about 10 cm and about 25 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D8 is about 16 cm. In some embodiments, the length D8 is based at least in part on patient anatomy, size, etc. The lead body 941 also defines a length D9 between the distal end of the bend 945 and a cap 949 or end of the stabilizer 948. In some embodiments, the length D9 is between about 10 cm and about 20 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D9 about 13.5 cm. In some embodiments, thelength D9 is based at least in part on patient anatomy, size, etc. The first shock coil 944a has and / or defines a length DIO. In some embodiments, the length DIO is between about 2 cm and about 5 cm. In some embodiments, the length DIO is about 3 cm. In some embodiments, the length DIO is based at least in part on patient anatomy, size, etc. The second shock coil 944b defines a length DI 1. In some embodiments, the length DI 1 is between about 0.5 cm and about 3 cm. In some embodiments, the length Dl l is about 1 cm. In some embodiments, the length DI 1 is based at least in part on patient anatomy, size, etc. The third shock coil 944c defines a length D12. In some embodiments, the length D12 is between about 2 cm and about 5 cm. In some embodiments, the length D12 is about 3 cm. In some embodiments, the length D12 is based at least in part on patient anatomy, size, etc. In some embodiments, the length D12 can be the same as the length DIO.

[0116] The lead body 941 also defines a length or distance D13 between the first electrode 946a and the second electrode 946b. In some embodiments, the length D13 is between about 0.5 cm and about 2.5 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D13 is about 1.25 cm. In some embodiments, the length D13 is based at least in part on patient anatomy, size, etc. The lead body 941 further defines an outer diameter DI 5. In some embodiments, the diameter DI 5 is between about 0.1 cm and about 0.5 cm, inclusive of all ranges and values therebetween. In some embodiments, the diameter DI 5 is about 0.3 cm. In some embodiments, the length D15 is based at least in part on patient anatomy, size, etc. In some embodiments, the shock coils 944 coil around the lead body any increase the outer diameter of the shock lead to a second outer diameter DI 6. In some embodiments, the second outer diameter D16 is between about 0.2 cm and about 0.6 cm, inclusive of all ranges and values therebetween. In some embodiments, the second outer diameter D16 is about 0.4 cm.

[0117] As shown in FIG. 9A-9D, the lead body 941 has a 3-D spatial structure that is based at least in part on a size and / or shape of the anterior mediastinum of the patient. In some embodiments, the lead body 941 can form and / or can include one or more loops or helixes. Moreover, the electrodes 946a, 946b are disposed at or along an outer or substantially outermost position of the loops or helixes. For example, the electrodes 946a, 946b can be included in and / or disposed on the loops or helixes at positions that are spaced apart from the shock coils 944a, 944b, 944c and / or other non-looped or non-helical portion of the lead body. Similarly stated, the 3-D spatial structure of the lead body 941 is such that the shock coils 944a, 944b, 944c are not co-planar and / or are not co-axial with the electrodes 946a, 946b. Asdescribed above with reference to the ICD leads 140 and 240, the 3-D spatial structure of the lead body 941 allows the lead to traverse the anterior mediastinal space such that the electrodes 946a, 946b (or outer portions of the loop(s) or helix(es)) engage, contact, and / or are otherwise in close proximity to the heart wall, while the shock coils 944a, 944b, 944c (or non-looped or non-helical portions of the lead body 941) engage, contact, and / or are otherwise in close proximity to a posterior surface of the sternum.

[0118] The lead body 941 can include any number of sensors 950. For example, as shown in FIGS. 9C-9E, the lead body 941 can include a first sensor 950a located between the shock coil 944a and the beginning of the looped portion that includes the first electrode 946a and a second sensor 950b located proximal to the cap 949 of the stabilizer 948 and / or otherwise at an end portion of the stabilizer 948. In some embodiments, the placement of the first sensor 950a and / or the second sensor 950b can be such that the sensors 950a / 950b are directed away from and / or spaced apart from anatomic structures that may interface with the ability of the sensors 950a / 950b to detect bio-signals in the anterior mediastinum of the patient (e.g., pressure signals, electrical signals, and / or the like). For example, the first sensors 950a can be between the shock coil 944a and the beginning of the looped portion 941b and can be directed away from the sternum (e.g., on a side of the lead body 941 that is directed away from the sternum. While the lead body 941 is shown as including the first sensor 950a and the second sensor 950b, in other embodiments, the lead body 941 can include a single sensor or can include more than two sensors.

[0119] The stabilizer 948, as shown in FIG. 9E, forms a hairpin shape with a curved portion distal to the shock coil 944c and proximal to a straight portion. In some embodiments, the curved portion has a radius of curvature of between about 0.5 cm and about 1.5 cm, inclusive of all ranges and values therebetween. In some embodiments, the curved portion has a radius of curvature of about 1.0 cm. The distal end of the stabilizer 948 can include the cap 949 that is distal to the second sensor 950b. In some embodiments, the second sensor 950b is integrated into and / or is a part of the cap 949. In some embodiments, the shape and / or arrangement of the stabilizer 948 may simplify manufacturing by allowing access to the distal end of the stabilizer 948 (e.g., allowing the cap 949 and / or second sensor 950b to be coupled thereto).

[0120] While certain structures, features, and / or aspects of the ICD lead 940 are particularly shown in FIGS. 9A-9E, the ICD lead 940 can be configured to function in a manner substantially similar to any of the ICD leads 140, 240, 340, and / or 440. Accordingly, the functioning and / or use of the ICD lead 940 is not described in further detail.

[0121] FIGS. 10A-10E depict various views of an ICD lead 1040 according to another embodiment. The ICD lead 1040 and / or portions thereof can be structurally and / or functionally similar to any of the ICD leads 140, 240, 340, and / or 440 (or corresponding portions thereof). Similar to the other ICD leads described herein, the ICD lead 1040 is configured to receive energy from a generator (e.g., functionally and / or structurally similar to the ICD generator 120 of FIGS. 1B-1C) and / or other power source. The ICD lead 1040 is configured to be implanted in a substemal space or anterior mediastinum of a patient. The ICD lead 1040 is configured, when implanted, to deliver treatment energy such as defibrillation energy and / or pacing energy. The ICD lead 1040 includes a generator interface 1042 (e.g., structurally and / or functionally similar to any of the generator interfaces 142, 242, 342, and / or 442), a lead body 1041 (e.g., functionally and / or structurally similar to the lead body 341 and / or 441), shock coils 1044a, 1044b, 1044c (e.g., functionally and / or structurally similar to any of the shock coil(s) 144, 244a / 244b / 244c, 344a / 344b / 344c, and / or 444a / 444b / 444c), electrodes 1046a, 1046b (e.g., functionally and / or structurally similar to any of the electrode(s) 146, 246a / 246b, 346a / 346b, and / or 446a / 446b), sensors 1050 (e.g., functionally and / or structurally similar to the sensor(s) 150 of FIGS. 1B-1C), and a distal end 1049. In contrast to the ICD lead 940 of FIGS. 9A-9E, the ICD lead 1040 includes a substantially straight distal end 1049 instead of a stabilizer (e.g., such as the stabilizer 948). In some embodiments, to stabilize the ICD lead 1040, the ICD lead 1040 can include a stabilizer functionally and / or structurally similar to any of the stabilizers described herein.

[0122] The generator interface 1042 includes connectors 1042a, 1042b, and 1042c. Each connector of the connectors 1042a, 1042b, 1042c can be configured to operatively couple to a different portion of the ICD lead 1040 and / or a different functional output of the generator. For example, a first connector 1042a can be configured to operatively couple to the shock coils 1044a, 1044b, 1044c and / or the electrodes 1046a, 1046b, a second connector 1042b can be configured to connect to a voltage source (e.g., about IV - 5V, inclusive of all ranges and values therebetween, etc.), and a third connector 1042c can be configured to couple to a positive and negative lead of the sensors 1050. In some embodiments, the first connector 1042a can be configured to couple to all of the shock coils 1044a, 1044b, 1044c together. In some embodiments, the first connector 1042a can be configured to couple to the electrodes 1046a, 1046b independently to allow for independent control of treatment energy delivery to each electrode 1046a, 1046b (e.g., can include a number of conductors and / or circuits corresponding to the number of electrodes). The generator interface 1042 defines a conduit length D17between the distal end of the connectors 1042a, 1042b, 1042c and the proximal end of the lead body 1041. In some embodiments, the length D17 is between about 3 cm and about 10 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D17 is about 5 cm. In some embodiments, the length D17 is based at least in part on patient anatomy, size, etc.

[0123] The lead body 1041, as seen in FIGS. 10A-10B, includes a bend 1045 that is configured to provide the lead body 1041 with strain relief. The bend 1045 defines an angle A2. In some embodiments, the angle A2 is between about 70 degrees and about 120 degrees, inclusive of all range and values therebetween. In some embodiments, the angle A2 is about 90 degrees. In some embodiments, the bend 1045 can be at least semi-flexible allowing the angle Al to be adjusted and / or set based at least in part on patient anatomy and / or other practical constraints. The lead body 1041 defines a length D18 between the proximal end of the lead body 1041 and the proximal end of the bend 1045. In some embodiments, the length DI 8 is between about 15 cm and about 35 cm, inclusive of all ranges and values therebetween. In some embodiments, the length DI 8 is about 25 cm. In some embodiments, the length DI 8 is based at least in part on patient anatomy, size, etc.

[0124] The lead body 1041 and the other components of the ICD lead 1040 define additional dimensions. For example, the lead body 1041 defines a length D12 between a distal end of the bend 1045 and a distal end 1049 of the ICD lead 1040. In some embodiments, the length DI 9 is between about 10 cm and about 25 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D19 is about 15 cm. In some embodiments, the length D19 is based at least in part on patient anatomy, size, etc. The treatment portions (e.g., sternal portions and heart wall portions) of the ICD lead 1040 define a length D20 between the proximal end of the treatment portions and the distal end of the treatment portions. In some embodiments, the length D20 is between about 5 cm and about 10 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D20 is about 8.5 cm. In some embodiments, the length D20 is based at least in part on patient anatomy, size, etc. The distal end 1049 of the ICD lead 1040 define a length D21 between the proximal end of the treatment portions and the distal cap of the ICD lead 1040. In some embodiments, the length D21 is between about 0.5 cm and about 2 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D21 is about 1 cm. In some embodiments, the length D21 is based at least in part on patient anatomy, size, etc.

[0125] The first shock coil 1044a has and / or defines a length D22. In some embodiments, the length D22 is between about 2 cm and about 5 cm. In some embodiments, the length D22 is about 3 cm. In some embodiments, the length D22 is based at least in part on patient anatomy, size, etc. The second shock coil 1044b defines a length D23. In some embodiments, the length D23 is between about 0.5 cm and about 3 cm. In some embodiments, the length D23 is about 1 cm. In some embodiments, the length D23 is based at least in part on patient anatomy, size, etc. The third shock coil 1044c defines a length D24. In some embodiments, the length D24 is between about 2 cm and about 5 cm. In some embodiments, the length D24 is about 3 cm. In some embodiments, the length D24 is based at least in part on patient anatomy, size, etc. In some embodiments, the length D24 can be the same as the length D22.

[0126] The lead body 1041 also defines a length or distance D25 between the first electrode 1046a and the second electrode 1046b. In some embodiments, the length D25 is between about 0.5 cm and about 2.5 cm, inclusive of all ranges and values therebetween. In some embodiments, the length D25 is about 1.25 cm. In some embodiments, the length D25 is based at least in part on patient anatomy, size, etc. The third shock coil 1044c further defines an outer diameter. In some embodiments, the outer diameter is between about 0.1 cm and about 0.6 cm, inclusive of all ranges and values therebetween. In some embodiments, the diameter is about 0.4 cm. In some embodiments, the outer diameter is based at least in part on patient anatomy, size, etc.

[0127] As shown in FIG. 10A-10D, the lead body 1041 has a 3-D spatial structure that is based at least in part on a size and / or shape of the anterior mediastinum of the patient. In some embodiments, the lead body 1041 can form and / or can include one or more loops or helixes. Moreover, the electrodes 1046a, 1046b are disposed at or along an outer or substantially outermost position of the loops or helixes. For example, the electrodes 1046a, 1046b can be included in and / or disposed on the loops or helixes at positions that are spaced apart from the shock coils 1044a, 1044b, 1044c and / or other non-looped or non-helical portion of the lead body. Similarly stated, the 3-D spatial structure of the lead body 1041 is such that the shock coils 1044a, 1044b, 1044c are not co-planar and / or are not co-axial with the electrodes 1046a, 1046b. As described above with reference to the ICD leads 140 and 240, the 3-D spatial structure of the lead body 1041 allows the lead to traverse the anterior mediastinal space such that the electrodes 1046a, 1046b (or outer portions of the loop(s) or helix(es)) engage, contact, and / or are otherwise in close proximity to the heart wall, while the shock coils 1044a, 1044b,1044c (or non-looped or non-helical portions of the lead body 1041) engage, contact, and / or are otherwise in close proximity to a posterior surface of the sternum.

[0128] The lead body 1041 can include any number of sensors 1050. For example, as shown in FIGS. 10C-10E, the lead body 1041 can include a first sensor 1050a located between the shock coil 1044a and the beginning of the looped portion that includes the first electrode 1046a and a second sensor 1050b located proximal to the cap 1051 of the distal end 1049 and / or otherwise at an end portion of the ICD lead 1040. In some embodiments, the placement of the first sensor 1050a and / or the second sensor 1050b can be such that the sensors 1050a / 1050b are directed away from and / or spaced apart from anatomic structures that may interface with the ability of the sensors 1050a / 1050b to detect bio-signals in the anterior mediastinum of the patient (e.g., pressure signals, electrical signals, and / or the like). For example, the first sensors 1050a can be between the shock coil 1044a and the beginning of the looped portion 1041b and can be directed away from the sternum (e.g., on a side of the lead body 1041 that is directed away from the sternum. While the lead body 1041 is shown as including the first sensor 1050a and the second sensor 1050b, in other embodiments, the lead body 1041 can include a single sensor or can include more than two sensors.

[0129] While certain structures, features, and / or aspects of the ICD lead 1040 are particularly shown in FIGS. 10A-10E, the ICD lead 1040 can be configured to function in a manner substantially similar to any of the ICD leads 140, 240, 340, and / or 440. Accordingly, the functioning and / or use of the ICD lead 1040 is not described in further detail.

[0130] Some embodiments described herein relate to and / or otherwise include a computer storage product with a non-transitory computer-readable medium (also can be referred to as a non-transitory processor-readable medium) having instructions or computer code thereon for performing various computer-implemented operations. The computer-readable medium (or processor-readable medium) is non-transitory in the sense that it does not include transitory propagating signals per se (e.g., a propagating electromagnetic wave carrying information on a transmission medium such as space or a cable). The media and computer code (also can be referred to as code) may be those designed and constructed for the specific purpose or purposes. Examples of non-transitory computer-readable media include, but are not limited to, magnetic storage media such as hard disks, floppy disks, and magnetic tape; optical storage media such as Compact Disc / Digital Video Discs (CD / DVDs), Compact Disc-Read Only Memories (CD- ROMs), and holographic devices; magneto-optical storage media such as optical disks; solid state storage media such as a solid state drive (SSD) and / or a solid state hybrid drive (SSHD);carrier wave signal processing modules; and hardware devices that are specially configured to store and execute program code, such as Application-Specific Integrated Circuits (ASICs), Programmable Logic Devices (PLDs), Read-Only Memory (ROM) and Random-Access Memory (RAM) devices. Other embodiments described herein relate to a computer program product, which can include, for example, the instructions and / or computer code discussed herein.

[0131] Some embodiments and / or methods described herein can be performed by software (executed on hardware), hardware, or a combination thereof. Hardware modules may include, for example, a general-purpose processor, an FPGA, an ASIC, and / or the like. Software modules (executed on hardware) can be expressed in a variety of software languages (e.g., computer code), including C, C++, Java™, Ruby, Visual Basic™, Python™, and / or other object-oriented, procedural, or other programming language and development tools. Examples of computer code include, but are not limited to, micro-code or micro-instructions, machine instructions, such as produced by a compiler, code used to produce a web service, and files containing higher-level instructions that are executed by a computer using an interpreter. For example, embodiments may be implemented using imperative programming languages (e.g., C, Fortran, etc.), functional programming languages (Haskell, Erlang, etc.), logical programming languages (e.g., Prolog), object-oriented programming languages (e.g., Java, C++, etc.) or other suitable programming languages and / or development tools, and / or combinations thereof (e.g., Python™). Additional examples of computer code include, but are not limited to, control signals, encrypted code, and compressed code.

[0132] 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 beapparent to those skilled in the art from the foregoing descriptions and are intended to fall within the scope of the disclosure.

[0133] 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.

[0134] 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.

[0135] 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

What is claimed is:

1. An implantable lead configured to be implanted in an anterior mediastinum of a patient, the implantable lead comprising: a generator interface configured to couple the implantable lead to a generator of an implantable treatment device; and a lead body coupled to the generator interface, the lead body comprising: a sternal portion configured to be positioned in the anterior mediastinum to engage a posterior portion of a sternum of the patient, and a heart wall portion configured to be positioned in the anterior mediastinum to engage a heart wall of a heart of the patient, wherein at least one of the sternal portion or the heart wall portion is configured to deliver treatment energy to the heart.

2. The implantable lead of claim 1, wherein the lead body has a 3-D spatial structure such that at least the heart wall portion extends radially away from an axis extending through the lead body.

3. The implantable lead of claim 2, wherein the 3-D spatial structure of the lead body is based at least in part on a shape of the anterior mediastinum of the patient.

4. The implantable lead of claim 1, further comprising: an electrical sensor configured to measure an electrical signal radiating from a pericardium of the heart of the patient; and a pressure sensor configured to measure a pressure signal within the anterior mediastinum.

5. The implantable lead of claim 4, wherein a change in the pressure signal in the anterior mediastinum is associated with at least one of a cardiac cycle or a respiratory cycle.

6. The implantable lead of claim 1, further comprising: at least one stabilizer configured to reduce motion of at least a portion of the lead relative to the heart when the implantable lead is implanted in the anterior mediastinum.

7. The implantable lead of claim 6, wherein the at least one stabilizer includes a curved distal end portion of the lead.

8. The implantable lead of claim 1, further comprising: a pressure sensor configured to measure a pressure signal within the anterior mediastinum.

9. The implantable lead of claim 1, wherein the sternal portion includes at least one shock coil and the heart wall portion includes at least one pacing electrode and at least one electrical sensor.

10. The implantable lead of claim 9, wherein the heart wall portion includes at least one radial extension, the at least one radial extension extending away from an axis defined by the sternal portion.

11. The implantable lead of claim 10, wherein the at least one radial extension includes a first radial extension and a second radial extension proximal to the first radial extension, wherein the first radial extension includes a first pacing electrode and the second radial extension includes a second pacing electrode.

12. The implantable lead of claim 11, wherein the first radial extension is a first loop having a first diameter and the second radial extension is a second loop having a second diameter larger than the first diameter.

13. A lead for an implantable cardioverter defibrillator (ICD), the lead configured to be implanted in an anterior mediastinum of a patient, the lead comprising: a generator interface configured to couple the lead to a generator of the ICD; a shock coil configured to deliver defibrillation treatment energy generated by the generator, the shock coil disposed on a sternal portion of the lead that is configured to engage a posterior portion of a sternum of the patient when the lead is implanted in the anterior mediastinum; and a pacing electrode configured to deliver pacing treatment energy generated by the generator, the pacing electrode disposed on a heart wall portion of the lead that is configuredto substantially contact a heart wall of the patient when the lead is implanted in the anterior mediastinum.

14. The lead of claim 13, further comprising: at least one stabilizer configured to reduce motion of at least a portion of the lead when the lead is implanted in the anterior mediastinum.

15. The lead of claim 14, wherein the at least one stabilizer includes a curved distal end portion of the lead.

16. The lead of claim 13, further comprising: an electrical sensor configured to measure an electrical signal radiating from a pericardium of the heart of the patient.

17. The lead of claim 13, further comprising: a pressure sensor configured to measure a pressure signal within the anterior mediastinum.

18. The lead of claim 13, wherein the lead has a 3-D spatial structure that is based at least in part on a shape of the anterior mediastinum of the patient.

19. A lead for an implantable cardioverter defibrillator (ICD), the lead configured to be implanted in an anterior mediastinum of a patient, the lead comprising: a generator interface configured to couple the lead to a generator of the ICD; an electrical sensor configured to detect an electrical signal radiating from a pericardium of a heart of the patient; a pressure sensor configured to detect a pressure in the anterior mediastinum; and a treatment portion including a shock coil and a pacing electrode, the treatment portion configured to support the lead between a sternum of the patient and a heart wall of the patient when the lead is implanted in the anterior mediastinum.

20. The lead of claim 19, wherein the lead is flexible.

21. The lead of claim 19, wherein the shock coil and the pacing electrode are arranged in series along the treatment portion of the lead.

22. The lead of claim 19, wherein the pacing electrode is a first pacing electrode, the treatment portion further includes: a first radial extension and a second radial extension proximal to the first radial extension, wherein the first radial extension includes the first pacing electrode and the second radial extension includes a second pacing electrode.

23. The lead of claim 22, wherein the first radial extension is a first loop having a first diameter and the second radial extension is a second loop having a second diameter larger than the first diameter.

24. A diagnostic / treatment device configured to be implanted in a patient, the diagnostic / treatment device comprising: a lead configured to implanted in an anterior mediastinum of the patient, the lead including an electrical sensor configured to detect electrical signals radiating from a pericardium of a heart of the patient and a pressure sensor configured to detect pressure signals in the anterior mediastinum; and a sensing device configured to be coupled to the lead via a lead interface, the sensing device including a memory and a processor configured to execute instructions stored in the memory that cause the processor to: determine a diagnostic status based at least in part on data from the electrical sensor, confirm the diagnostic status based at least in part on data from the pressure sensor, and in response to confirming the diagnostic status, generate at least one action associated with the diagnostic status.

25. The diagnostic / treatment device of claim 24, wherein the at least one action associated with the diagnostic status includes: monitoring a change in the diagnostic status over a predetermined time, and sending a signal indicative of at least one characteristic associated with the change in the diagnostic status over the predetermined time.

26. The diagnostic / treatment device of claim 24, wherein the sensing device is a cardiac treatment device configured to generate treatment energy.

27. The diagnostic / treatment device of claim 26, wherein the lead further includes a shock coil configured to deliver defibrillation treatment energy and a pacing electrode configured to deliver pacing treatment energy, the at least one action includes delivering treatment energy generated by the cardiac treatment device to at least one of the shock coil or the pacing electrode based on diagnostic status.

28. The diagnostic / treatment device of claim 27, wherein the electrical sensor is formed at least in part by the pacing electrode.

29. The diagnostic / treatment device of claim 27, wherein the treatment energy is a cardiac pacing impulse.

30. The diagnostic / treatment device of claim 24, wherein the lead further includes an epicardial portion including at least one electrode, the epicardial portion configured to be implanted in pericardial cavity or epicardial tissue of a left ventricle of the heart, a right ventricle of the heart, or both the left and the right ventricles of the heart.

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