Patent ID: 12201846

DETAILED DESCRIPTION

It will be readily understood that the components of the embodiments as generally described and illustrated in the figures herein, may be arranged and designed in a wide variety of different configurations in addition to the described example embodiments. Thus, the following more detailed description of the example embodiments, as represented in the figures, is not intended to limit the scope of the embodiments, as claimed, but is merely representative of example embodiments.

FIG.1illustrates an implantable medical device (IMD)8coupled to a heart9in a patient and implemented in accordance with one embodiment. The IMD8may be a cardiac pacemaker, an implantable cardiac monitoring device (ICM), a defibrillator, an ICM coupled with a pacemaker, or the like. The IMD100is intended for subcutaneous implantation at a site near the heart9. The IMD8may be a dual-chamber stimulation device capable of treating both fast and slow arrhythmias with stimulation therapy, including cardioversion, defibrillation, and pacing stimulation, as well as capable of detecting heart failure, evaluating its severity, tracking the progression thereof, and controlling the delivery of therapy and warnings in response thereto. The IMD8may be controlled to sense atrial and ventricular waveforms of interest, discriminate between two or more ventricular waveforms of interest, deliver stimulation pulses for pacing and/or shocks, and inhibit application of a stimulation pulse to a heart based on the discrimination between the waveforms of interest and the like. Exemplary structure for the IMD8is discussed and illustrated below in connection withFIG.9.

The IMD8includes a body or housing10that is connected to at least one lead11. The leads11are cardiac leads that extend from the housing10to the heart9of the patient. A proximal end of each lead is connected to the housing10, and a distal end of each lead is in contact with patient tissue surrounding the heart9. Three leads11are shown inFIG.1, but the IMD8may include more or less than three leads in another embodiment.

The leads11measure cardiac signals of the heart9and deliver stimulation therapy to the heart9. For example, the leads11may detect intracardiac electrogram (IEGM) signals that form an electrical activity indicator of myocardial function over multiple cardiac cycles of the heart9. The leads11may include a right ventricular lead11A, a right atrial lead11B, and a coronary sinus lead11C. Each lead11includes a respective lead body12and at least one electrode13. The leads11in the illustrated embodiment have multiple electrodes13. The electrodes13may deliver electrical stimulation or pulses to the patient tissue in contact with the electrodes13. The electrode13may also sense to receive cardiac signals (e.g., IEGM signals) from the heart9. In an embodiment, a single electrode13may emit a stimulation pulse in a stimulation mode, and then may quickly switch to a monitoring mode to detect cardiac signals following the stimulation pulse.

The electrodes13may include a tip electrode13A, a ring electrode13B, a coil electrode13C, and/or the like. On the right ventricular lead11A, the tip electrode13A is located at the distal end of the lead11A, opposite the end extending from the housing10. The ring electrode13B and the coil electrode13C of the lead11A are disposed between the tip electrode13A and the housing10along the length of the lead11A, although are closer to the tip electrode13A than to the housing10. The tip electrode13A is separated from the ring electrode13B by a length of the lead body12. The ring electrode13B is separated from the coil electrode13C by another length of the lead body12.

The housing10may contain a battery, pulse generation circuitry, communication circuitry, a data storage device (e.g., memory), and/or control circuitry. The control circuitry is for receiving and analyzing electrocardiogram IEGM signals from the electrodes13. The control circuitry may include at least one processor for processing the IEGM signals in accordance with algorithms to make determinations about the state of the heart9. The memory provides storage for the cardiac signals and programmed instructions for the control circuitry. The battery powers the circuitry with the housing10. For example, the battery powers the pulse generation circuitry to generate stimulation pulses and powers the communication circuitry to communicate with an external device16. The control circuitry may generate messages to be communicated via the communication circuitry to the external device16. The messages may include the IEGM signals and/or data generated based on the IEGM signals.

The external device16may represent a portable smartphone, tablet device, bedside monitor installed in a patient's home, or the like. The external device16may be a programmer device used in the clinic to interrogate the IMD8, retrieve data and program detection criteria and other features. The external device16facilitates access by physicians to patient data as well as permits the physician to review real-time electrocardiogram (ECG) signals while being collected by the IMD8.

Although several embodiments described herein are directed to IMDs with leads, one or more of the embodiments can be applied to leadless IMDs, such as a leadless pacemaker, neurostimulation device, pressure sensor, or the like. For example, the electrodes described herein optionally may be attached to a housing or case, instead of to a lead. The electrodes may be adhesively bonded to an insulative material of the housing or case, rather than an insulative material of a lead body of a lead.

FIG.2is a side view of a portion of a lead100of an IMD according to an embodiment. The lead100may be one of the leads11shown inFIG.1. The lead100includes a lead body102and at least one electrode104. InFIG.2, the lead body102is shown in phantom, and one electrode104is depicted. The electrode104inFIG.2in an embodiment is a ring electrode, such as the ring electrode13B shown inFIG.1. The electrode104may be a different type of electrode in an alternative embodiment, such as a tip electrode.

The electrode104includes a metal substrate106and a metal coating108disposed on a portion of the metal substrate106. The metal substrate106has a first end110and a second end112. In the illustrated embodiment, the metal substrate is oriented about a length axis113from the first end110to the second end112, such that the first end110is opposite the second end112.

The metal substrate106includes an active segment114and at least one connection segment along the length of the metal substrate106. The active segment114delivers stimulation pulses and/or senses cardiac signals. The metal coating108is located along the active segment114. The metal coating108may enhance the electrical activity of the electrode104by increasing the surface area along an exposed outer surface of the electrode104at the active segment114and decreasing electrical polarization. Decreasing the electrical polarization reduces the amount of time that residual voltage remains on the electrode104, which enables the electrode104to quickly switch from a stimulation mode to a sensing mode.

The connection segment(s) attach to the lead body102to secure the electrode104to the lead body102. In the illustrated embodiment, the metal substrate106includes a first connection segment116and a second connection segment118. The active segment114is disposed between the first and second connection segments116,118along the length of the metal substrate106. For example, the first connection segment116extends from the active segment114to the first end110, and the second connection segment118extends from the active segment114to the second end112.

The first connection segment116is secured to an insulative material120of the lead body102via an adhesive. The insulative material120refers to an electrically insulative material, such as a dielectric material. The insulative material120surrounds the first connection segment116of the metal substrate106. The insulative material120does not surround the active segment114. The insulative material120may be a tube or sleeve.

In one or more embodiments, the metal coating108is disposed on the first connection segment116in addition to the active segment114. For example, the adhesive adheres to the metal coating108on the first connection segment116. As described in more detail herein, the metal coating108increases the bond strength at the interface between the first connection segment116of the metal substrate106and the insulative material120of the lead body102, relative to not applying the metal coating108on the first connection segment116.

The metal coating108on the active segment114is exposed to the external environment surrounding the lead100. When implanted, the external environment includes organic endocardial tissues and fluids of the patient surrounding the lead100. The metal coating108on the active segment114experiences physical contact with the patient tissues to establish direct and persistent electrode-tissue contact for efficient stimulation and accurate sensing. The metal coating108on the first connection segment116is covered by the insulative material120of the lead body102. As such, the metal coating108on the first connection segment116does not physically contact the patient tissue.

In the illustrated embodiment, the metal coating108is not present on the second connection segment118of the metal substrate106. The outer surface of the metal substrate106is covered with the metal coating108along the first connection segment116and the active segment114, but not the second connection segment118. The second connection segment118may be attached to a second portion of the lead body102via a different attachment mechanism than the first connection segment116. For example, the second connection segment118may be connected to the lead body102, or one or more conductors thereof, via welding.

In a first alternative embodiment, the second connection segment118is also coated with the metal coating108. The outer surface of the metal substrate106may be coated with the metal coating108along the entire length of the metal substrate106. This embodiment may be used when the second connection segment118is bonded to an insulative material of the lead body102via an adhesive, like the first connection segment116.

In a second alternative embodiment, the metal substrate106of the electrode104does not include the second connection segment118. For example, the metal substrate106may include only the connection segment116and the active segment114along the length of the metal substrate106. Both the connection segment116and the active segment114are coated with the metal coating108, as described above. This embodiment may be used when the electrode104is located at the distal end of the lead100, such as a tip electrode.

FIG.3is an isolated perspective view of the electrode104of the lead100shown inFIG.2. The metal substrate106in the illustrated embodiment has a hollow, generally cylindrical shape that defines a channel122therethrough. The channel122extends from the first end110to the second end112, and is open along both ends110,112. The channel122extends along the length axis113shown inFIG.2. The metal substrate106may be formed via a molding or casting process. The metal substrate106may have a unitary, monolithic (e.g., one-piece) body such that the segments114,116,118are integrally connected at seamless interfaces. The active segment114may have a larger outer diameter than the connection segments116,118. For example, the first connection segment116may interface with the active segment114at a first stepped edge126, and the second connection118may interface with the active segment114at a second stepped edge128.

The first connection segment116may define one or more apertures124through a thickness of the metal substrate106. When bonding the electrode104to the insulative material120of the lead body102(shown inFIG.2) during lead assembly, the one or more apertures124provide contour for mechanically anchoring the adhesive to the electrode104, as shown inFIG.7. The first connection segment116includes four apertures124in the illustrated embodiment, but other embodiments may include more or less than four apertures124. The apertures124are spaced apart along a circumference of the connection segment116.

Optionally, the second connection segment118includes a flange130that extends circumferentially along the outer surface of the metal substrate106. The flange130may be used to secure the second connection segment118to the lead body102.

FIG.4is a cross-sectional view of the electrode104taken along line4-4inFIG.3. The illustrated view shows the first connection segment118of the metal substrate106and the metal coating108. The cross-section extends across the apertures124. The metal coating108is directly disposed on an outer surface132of the metal substrate106. The metal coating108may be a thin layer that coats the outer surface132. For example, the metal coating108may be thinner than the metal substrate106at the connection segment116. The thickness of the metal coating108may be on the order of micrometers, such as between 1 and 1000 micrometers.

In one or more embodiments, the metal substrate106is composed of platinum, iridium, and/or titanium. These metals have beneficial properties for implantable electrodes. For example, these metals are inert and have relatively high corrosion resistance. For example, the metal substrate106may be a platinum alloy that includes platinum and at least one other metal. In a non-limiting example, the metal substrate106is a platinum iridium (Pt/Ir) alloy. In another example, the metal substrate106may be at least 90% platinum by weight of the metal substrate, such as at least 95% platinum by weight. Alternatively, the metal substrate106may be at least 90% by weight of titanium or iridium.

The downside of these metals is that it is difficult to form adhesive bonds between these metals and insulative materials due to the metals having generally poor bond strengths. For example, the adhesive does not strongly bond to the metal. The deposition of the metal coating108on the metal substrate106, according to the embodiments described herein, remedies this issue by increasing the adhesive bond strength between the electrode104and the insulative material120.

The metal coating108is composed of titanium nitride (TiN), platinum black, or iridium oxide. In at least one embodiment, the metal coating is TiN. In a non-limiting example, the metal coating is composed of TiN, and the metal substrate is composed of the Pt/Ir alloy or another platinum alloy. The TiN has a complex geometry with a fractal nature. The fractal nature of the TiN promotes the bonding between the metal substrate106and the adhesive used to secure the lead body insulative material120. The platinum black and iridium oxide also have complex geometries that promote bonding between the metal substrate106and the adhesive by increasing the surface area of the electrode104.

In the illustrated embodiment, the outer surface132of the metal substrate106is generally smooth. The metal substrate106is not subjected to an abrasive surface treatment to roughen the outer surface132prior to applying the metal coating108on the outer surface132. For example, the metal substrate106is not subjected to grit blasting, sand blasting, or the like. Abrasive surface treatments on the inert metal surface of the electrode is one traditional technique for increasing the surface area of the metal improve adhesion between the electrode and the lead body, relative to applying the adhesive directly on a smooth surface of the electrode. In an embodiment, depositing the metal coating108on the first connection segment116of the electrode104provides yield sufficient bond strength to eliminate the need for the abrasive surface treatment. For example, the adhesive bond strength provided by applying an adhesive on the metal coating108disposed directly on a generally smooth outer surface132of the metal substrate106may be greater than the adhesive bond strength provided by applying the same adhesive directly on an abrasive surface-treated outer surface of the metal substrate. The electrode104according one or more embodiments does not utilize an abrasive surface treatment, which can reduce costs and increase throughput during the manufacturing process.

FIG.5illustrates an exploded view of the lead100showing the lead body102poised for attachment to the first connection segment116of the electrode104according to an embodiment. In the illustrated embodiment, the insulative material120of the lead body102is a tube140that surrounds one or more conductors142of the lead100. The conductors142may be metal wires or elements that provide an electrically conductive pathway for signal and/or stimulation transmission. The insulative material120(e.g., tube140) is composed of one or more polymers. For example, the insulative material120may include silicone (e.g., silicone rubber), polyurethane, or a mixture of both. In a non-limiting example, the insulative material120is a silicone—polyurethane copolymer trademarked as Optim™. During assembly of the lead100, the conductors142may extend into the channel122of the electrode104, and the tube140is loaded onto the first connection segment116to surround the first connection segment116.

FIG.6is a cross-sectional view of the electrode104taken along line6-6inFIG.3. The metal substrate106has an inner surface150opposite the outer surface132. The inner surface150defines the channel122through the metal substrate106. Optionally, the metal coating108is disposed on both the outer surface132and the inner surface150, along at least portion of the length of the metal substrate106. For example, the metal coating108may be applied on the inner surface150along at least the first connection segment116. Applying the metal coating108along the inner surface150of the first connection segment116may enhance the bonding of the adhesive to the metal substrate106, particularly the portions of the adhesive that flow through the apertures124. In one embodiment, the metal coating108is applied to the inner surface150along just the first connection segment116to conserve the metal coating material. In a second embodiment, the metal coating108is applied to the inner surface150along both the first connection segment116and the active segment114. In a third embodiment, the metal coating108may be applied along the entire inner surface150to avoid masking the inner surface150.

FIG.7is a close-up view of a portion of the cross-sectioned electrode104shown inFIG.6with the first connection segment116bonded to the insulative material120of the lead body102according to an embodiment. To assemble the lead100, after the metal coating108is applied on the first connection segment116the adhesive152is deposited on the metal coating108and/or on an interior surface154of the insulative material120. The adhesive152may be a medical grade adhesive that is safe for use within a patient body. The adhesive152may be a silicone room temperature vulcanizing (RTV) sealant or the like. The insulative material120is then loaded onto the electrode104to surround the first connection segment116without surrounding the active segment114.

The adhesive152is disposed between the metal coating108on the first connection segment116and the interior surface154of the insulative material120. Portions of the adhesive152may flow into the apertures124and engage the inner surface150of the first connection segment116. As the adhesive152solidifies, those portions within the apertures124may mechanically anchor the adhesive152in place relative to the electrode104. The adhesive152bonds directly to the metal coating108, instead of to the metal substrate106underneath the coating108. The metal coating108provides greater bond strength than if the adhesive152is bonded to the metal substrate106, particularly when the metal substrate106is composed of platinum, iridium, and/or titanium. Applying the metal coating108along the inner surface150of the first connection segment116may enhance the anchoring of the adhesive152to the electrode104, relative to the inner surface150being uncoated.

The adhesive152may bond well to the insulative material120of the lead body102, providing a strong connection between the electrode104and the lead body102that can withstand the harsh environment within the patient body, including prolonged exposure to organic fluids and impacts and abrasive forces due to patient body movement. The adhesive152also provides a hermetic seal at the interface between the electrode104and the lead body102.

The metal coating108disclosed herein has favorable electrical properties and is applied on the surface of the active segment114of the electrode104to enhance polarization (e.g., quickly dissipate electric current from the electrode). The embodiments disclosed herein extend the coverage of the metal coating108to another segment of the electrode104and utilize the metal coating108for a different purpose. As described herein, the metal coating108is applied on the surface of the (first) connection segment116. The complex geometry of the metal coating108provides increased surface area (e.g., “grip”) to which an adhesive can adhere.

Applying the metal coating108on the connection segment116increases the adhesive bond strength between the electrode104and the insulative material120of the lead body102, relative to depositing the adhesive directly on an untreated surface of the metal substrate106. Furthermore, extending the metal coating108to the connection segment116to improve the bond strength can replace other techniques for improving the bond strength, such as performing abrasive surface treatments on the metal substrate106. The application of the metal coating108to the connection segment116may not represent an additional manufacturing step, but rather merely an extension of a pre-existing step to apply a metal coating on the active segment114for the favorable electrical properties.

Extending the coverage of the metal coating108to include both the active segment114and the connection segment116may actually improve efficiency by reducing the amount of surface area that is masked prior to depositing the metal coating108on the metal substrate106. For example, neither the active segment114nor the connection segment116gets masked before the metal coating108is applied. The masking process tends to be manual and laborious, so reducing the amount of masking can reduce costs and improve manufacturing efficiency and throughput.

FIG.8is a flow chart200of a method of providing an electrode of a lead for an implantable medical device (IMD) according to an embodiment. The method may be performed to produce the electrode104described with reference toFIGS.2through7. The method may include more steps than shown inFIG.8and/or different steps than the steps shown inFIG.8.

At202, a metal substrate is formed to include a connection segment and an active segment along a length of the metal substrate. The metal substrate is composed of platinum, iridium, and/or titanium. The connection segment is configured to be bonded to an insulative material of a lead body via an adhesive. Optionally, the connection segment is formed to define multiple apertures through a thickness of the metal substrate for anchoring the adhesive to the connection segment. Optionally, the metal substrate is formed to also include a second connection segment. The metal substrate may be a ring electrode than has a generally cylindrical hollow shape.

At204, a metal coating is applied on an outer surface of the metal substrate along the connection segment and the active segment. The metal coating is composed of titanium nitride, platinum black, or iridium oxide. The metal coating may be applied through any conventional coating technique, such as thermal spraying, electroplating, dipping, painting, cladding, vapor deposition, or the like. Optionally, the metal coating is also applied on an inner surface of the metal substrate along at least the connection segment. The inner surface defines a channel through the length of the electrode. Optionally, the metal coating is just applied to the connection segment and the active segment. The metal coating may not be disposed on other portions of the metal substrate, such as the second connection segment. Optionally, when the connection segment defines the apertures therethrough for anchoring the adhesive, the metal coating is also applied to the area of the metal substrate in and surrounding the apertures.

Optionally, the metal coating is applied to the outer surface after the metal substrate is formed without any intervening surface treatments, such as abrasive grit blasting, on the connection segment of the metal substrate. The outer surface of the metal substrate on which the metal coating is applied may be generally smooth.

The electrode produced via the method inFIG.8can be assembled with a lead body to form a lead, such as the lead100inFIG.2. The assembly process optionally includes applying an adhesive on the metal coating along the connection segment for bonding to the insulative material of the lead body. The adhesive is a medical grade adhesive. After the adhesive is applied on the metal coating, the insulative material of the lead body, such as a tube, may be loaded onto the metal substrate to surround the connection segment. The adhesive may be sandwiched between the outer surface of the connection segment and the interior surface of the insulative tube. The adhesive bonds the insulative tube of the lead body to the electrode with sufficient bond strength to withstand the harsh conditions inside the patient body for a prolonged period of time without the adhesive interface failing.

FIG.9illustrates a multi-lead IMD900implanted proximate to a patient heart912according to an embodiment. The IMD900may be a dual-chamber stimulation device capable of treating both fast and slow arrhythmias with stimulation therapy, including cardioversion, defibrillation, and pacing stimulation. To provide other atrial chamber pacing stimulation and sensing, housing901is shown in electrical communication with the heart912by way of a left atrial lead920having an atrial tip electrode922and an atrial ring electrode923implanted in the atrial appendage. The housing901is also in electrical communication with the heart by way of a right ventricular lead930having, in this embodiment, a ventricular tip electrode932, a right ventricular ring electrode934, a right ventricular (RV) coil electrode936, and a superior vena cava (SVC) coil electrode938. Typically, the right ventricular lead930is transvenously inserted into the heart so as to place the RV coil electrode936in the right ventricular apex, and the SVC coil electrode938in the superior vena cava. Accordingly, the right ventricular lead930is capable of receiving cardiac signals, and delivering stimulation in the form of pacing and shock therapy to the right ventricle.

To sense left atrial and ventricular cardiac signals and to provide left chamber pacing therapy, the housing901is coupled to a multi-pole LV lead924designed for placement in the coronary sinus (CS) region, which refers to the venous vasculature of the left ventricle, including any portion of the CS, great cardiac vein, left marginal vein, left posterior ventricular vein, middle cardiac vein, and/or small cardiac vein or any other cardiac vein accessible by the CS. Accordingly, an exemplary LV lead924is designed to receive atrial and ventricular cardiac signals and to deliver left ventricular pacing therapy using a set of four left ventricular electrodes9261(D1),9262(M2),9263(M3), and9264(P4), (thereby providing a quad-pole lead), left atrial pacing therapy using at least a left atrial ring electrode927, and shocking therapy using at least a left atrial coil electrode928. The9261LV electrode may also be referred to as a “tip” or “distal” LV electrode. The9264LV electrode may also be referred to as a “proximal” LV electrode. In other examples, more or fewer LV electrodes are provided. Although only three leads are shown inFIG.9, it should also be understood that additional leads (with one or more pacing, sensing and/or shocking electrodes) might be used and/or additional electrodes might be provided on the leads already shown, such as additional electrodes on the RV lead. Also, note that the P4electrode9264is preferably located in or near the AV groove, as discussed and described above. The details of this configuration are not necessarily shown in this particular figure.

It is noted that, in practice, electrodes926are on the “left heart lead” and depending upon where the lead is implanted, in most patients, all four electrodes can be in LV but in a substantial minority of patients the P4electrode is situated in the LA (specifically in AV groove). As noted above, the P4electrode is the electrode on which LA activation is sensed (which can also be present even if the electrode is primarily on the LV instead of LA). On present commercially-available hardware, there is often no separate electrode927. That is, the P4electrode9264and the “left atrial ring electrode”927are one and the same. Hence, it should be understood that the “left atrial ring electrode” could instead be used as the P4electrode, assuming it is suitably positioned in or near the AV groove. Both electrodes are shown for the sake of completeness and generality.

The embodiments described above with reference toFIGS.2through8may be applied to one or more of the electrodes and leads shown inFIG.9.

While the foregoing embodiments are described in connection with an electrode on a lead, it is recognized that embodiments may be implemented with a variety of other implantable medical systems.

Embodiments may be implemented in connection with one or more implantable medical devices (IMDs). Non-limiting examples of IMDs include one or more of neurostimulator devices, implantable leadless monitoring and/or therapy devices, and/or alternative implantable medical devices. For example, the IMD may represent a cardiac monitoring device, pacemaker, cardioverter, cardiac rhythm management device, defibrillator, neurostimulator, leadless monitoring device, leadless pacemaker and the like. For example, the IMD may include one or more structural and/or functional aspects of the device(s) described in U.S. Pat. No. 9,333,351 “Neurostimulation Method And System To Treat Apnea” and U.S. Pat. No. 9,044,610 “System And Methods For Providing A Distributed Virtual Stimulation Cathode For Use With An Implantable Neurostimulation System”, which are hereby incorporated by reference.

Additionally or alternatively, the IMD may be a leadless implantable medical device (LIMD) that include one or more structural and/or functional aspects of the device(s) described in U.S. Pat. No. 9,216,285 “Leadless Implantable Medical Device Having Removable And Fixed Components” and U.S. Pat. No. 8,831,747 “Leadless Neurostimulation Device And Method Including The Same”, which are hereby incorporated by reference. Additionally or alternatively, the IMD may include one or more structural and/or functional aspects of the device(s) described in U.S. Pat. No. 8,391,980 “Method And System For Identifying A Potential Lead Failure In An Implantable Medical Device” and U.S. Pat. No. 9,232,485 “System And Method For Selectively Communicating With An Implantable Medical Device”, which are hereby incorporated by reference. For example, the electrode104inFIGS.2through7may be attached via an adhesive bond to a housing or header of the LIMD according to at least one of these patents and applications.

Additionally or alternatively, the IMD may be a subcutaneous IMD that includes one or more structural and/or functional aspects of the device(s) described in U.S. application Ser. No. 15/973,195, titled “Subcutaneous Implantation Medical Device With Multiple Parasternal-Anterior Electrodes” and filed May 7, 2018; U.S. application Ser. No. 15/973,219, titled “Implantable Medical Systems And Methods Including Pulse Generators And Leads” filed May 7, 2018; U.S. application Ser. No. 15/973,249, titled “Single Site Implantation Methods For Medical Devices Having Multiple Leads”, filed May 7, 2018, which are hereby incorporated by reference in their entireties. For example, the electrode104inFIGS.2through7may be a component of a lead as described in at least one of these patents and applications. Further, one or more combinations of IMDs may be utilized from the above incorporated patents and applications in accordance with embodiments herein.

Additionally or alternatively, the IMD according to one or more embodiments may be a leadless cardiac monitor (ICM) that includes one or more structural and/or functional aspects of the device(s) described in U.S. Pat. No. 9,949,660, filed Mar. 29, 2016, entitled, “Method And System To Discriminate Rhythm Patterns In Cardiac Activity,” which is expressly incorporated herein by reference. For example, the electrode104inFIGS.2through7may be attached via an adhesive bond to a housing or header of the ICM according to this patent.

Embodiments may be implemented utilizing all or portions of the methods and systems described in U.S. application Ser. No. 16/930,791, filed Jul. 16, 2020 and titled “Methods, Devices And Systems For Holistic Integrated Healthcare Patient Management”.

Embodiments may be implemented in connection with one or more PIMDs. Non-limiting examples of PIMDs may include passive wireless sensors used by themselves, or incorporated into or used in conjunction with other IMDs such as cardiac monitoring devices, pacemakers, cardioverters, cardiac rhythm management devices, defibrillators, neurostimulators, leadless monitoring devices, leadless pacemakers, replacement valves, shunts, grafts, drug elution devices, blood glucose monitoring systems, orthopedic implants, and the like. For example, the PIMD may include one or more structural and/or functional aspects of the device(s) described in U.S. Pat. No. 9,265,428 entitled “Implantable Wireless Sensor”, U.S. Pat. No. 8,278,941 entitled “Strain Monitoring System and Apparatus”, U.S. Pat. No. 8,026,729 entitled “System and Apparatus for In-Vivo Assessment of Relative Position of an Implant”, U.S. Pat. No. 8,870,787 entitled “Ventricular Shunt System and Method”, and U.S. Pat. No. 9,653,926 entitled “Physical Property Sensor with Active Electronic Circuit and Wireless Power and Data Transmission”, which are all hereby incorporated by reference in their respective entireties. For example, the electrode104inFIGS.2through7may be attached via an adhesive bond to a housing or header of the ICM according to at least one of these patents.

The physiologic sensor may be implemented as an accelerometer and may be implemented utilizing all or portions of the structural and/or functional aspects of the methods and systems described in U.S. Pat. No. 6,937,900, titled “AC/DC Multi-Axis Accelerometer for Determining A Patient Activity and Body Position;” U.S. application Ser. No. 17/192,961, filed Mar. 5, 2021, titled “System For Verifying A Pathologic Episode Using An Accelerometer”; U.S. application Ser. No. 16/869,733, filed May 8, 2020, titled “Method And Device For Detecting Respiration Anomaly From Low Frequency Component Of Electrical Cardiac Activity Signals;” U.S. application Ser. No. 17/194,354, filed Mar. 8, 2021, titled “Method And Systems For Heart Condition Detection Using An Accelerometer,” the complete subject matter which is expressly incorporated herein by reference.

All references, including publications, patent applications and patents, cited herein are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.

It should be clearly understood that the various arrangements and processes broadly described and illustrated with respect to the figures, and/or one or more individual components or elements of such arrangements and/or one or more process operations associated of such processes, can be employed independently from or together with one or more other components, elements and/or process operations described and illustrated herein. Accordingly, while various arrangements and processes are broadly contemplated, described and illustrated herein, it should be understood that they are provided merely in illustrative and non-restrictive fashion, and furthermore can be regarded as but mere examples of possible working environments in which one or more arrangements or processes may function or operate.

Reference throughout this specification to “one embodiment” or “an embodiment” (or the like) means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” or the like in various places throughout this specification are not necessarily all referring to the same embodiment.

Furthermore, the described features, structures, or characteristics may be combined in any suitable manner in one or more embodiments. In the preceding description, numerous specific details are provided to give a thorough understanding of embodiments. One skilled in the relevant art will recognize, however, that the various embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well-known structures, materials, or operations are not shown or described in detail to avoid obfuscation. The preceding description is intended only by way of example, and simply illustrates certain example embodiments.

It is to be understood that the subject matter described herein is not limited in its application to the details of construction and the arrangement of components set forth in the description herein or illustrated in the drawings hereof. The subject matter described herein is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

Approximating language, as used herein throughout the specification and claims, may be applied to modify any representation that could permissibly vary without resulting in a change in the basic function to which it may be related. Accordingly, a term modified by “about,” “substantially,” “generally,” and “approximately,” is inclusive of conditions that permissibly vary from the stated term without resulting in a change of the basic function of the term. For example, the phrase “generally smooth” when used in reference to a surface can indicate that the surface appears smooth to the naked eye of an observer, although it is permissible and even probable that the surface under closer examination may include some imperfections and/or variations.

It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described embodiments (and/or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a particular situation or material to the teachings herein without departing from its scope. While the dimensions, types of materials and coatings described herein are intended to define various parameters, they are by no means limiting and are illustrative in nature. Many other embodiments will be apparent to those of skill in the art upon reviewing the above description. The scope of the embodiments should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects or order of execution on their acts.