Implantable medical device having two electrodes in the header

Various aspects of the present disclosure are directed toward apparatuses, systems, and methods for supporting components of an implantable medical device. The apparatuses, systems, and methods may include a first electrode and a second electrode and a scaffold assembly configured to support the first electrode and the second electrode.

TECHNICAL FIELD

Embodiments of the present disclosure relate to medical devices and systems for sensing physiological parameters and/or delivering therapy. More specifically, embodiments of the disclosure relate to devices and methods for header core fixation in an implantable medical device.

BACKGROUND

Implantable medical devices (IMDs) may be configured to sense physiological parameters and/or provide therapy and may include one or more electrodes for performing aspects of these functions. IMDs may also include antennas for communicating with other devices. Conventionally, devices such as programmers and wands have been used to cause IMDs to take various actions such as for example, marking recordings of physiological parameters, initiating communications with other devices, and the like.

SUMMARY

In Example 1, an apparatus for supporting components of an implantable medical device includes a first electrode and a second electrode; and a scaffold assembly configured to support and separate the first electrode and the second electrode relative to a longitudinal axis of the scaffold assembly.

In Example 2, further to the apparatus of Example 1, the scaffold assembly is configured to support the first electrode along a first surface of the scaffold assembly and the second electrode along a second surface of the scaffold assembly that opposes the first surface.

In Example 3, further to the apparatus of any one of Examples 1-2, the scaffold assembly is configured to arrange the first electrode parallel to the second electrode.

In Example 4, further to the apparatus of Example 3, the scaffold assembly includes a frontward facing portion and a rearward facing portion, and the first electrode is arranged on the frontward facing portion and the second electrode is arranged on the rearward facing portion.

In Example 5, further to the apparatus of any one of Examples 1-3, the apparatus also includes the implantable medical device having a header, a core assembly including integrated circuitry configured to select between the first electrode and the second electrode.

In Example 6, further to the apparatus of Example 5, the integrated circuitry is configured to measure sensing capability of the first electrode and sensing capability of the second electrode and select between the first electrode and the second electrode in response to determining a greater of the sensing capability of the first electrode and the sensing capability of the second electrode.

In Example 7, further to the apparatus of Example 6, the integrated circuitry is configured to measure impedance on a sensed signal of the first electrode and an impedance on a sensed signal of the second electrode to determine the sensing capability of the first electrode and the sensing capability of the second electrode.

In Example 8, further to the apparatus of any one of Examples 5-7, the first electrode and the second electrode are arranged at a proximal end of the core assembly and further comprising a third electrode arranged at a distal end of the core assembly.

In Example 9, further to the apparatus of Example 8, the integrated circuitry is configured to drive the third electrode and one of the first electrode and the second electrode and to sense another of the first electrode and the second electrode.

In Example 10, further to the apparatus of any one of Examples 5-9, the scaffold assembly is arranged within the header and the scaffold assembly is configured to support and position the first electrode and with a first surface of an interior portion of the header and position the second electrode and with a second surface of the interior portion of the header.

In Example 11, further to the apparatus of any one of Examples 5-10, the integrated circuitry includes a Kelvin connection to the first electrode and the second electrode.

In Example 12, further to the apparatus of any one of Examples 5-11, the apparatus also includes a first electrical connector configured to connect the first electrode to the integrated circuitry within the core assembly and a second electrical connector configured to connect the second electrode to the integrated circuitry within the core assembly.

In Example 13, further to the apparatus of any one of Examples 1-12, the apparatus also includes an antenna arranged on the scaffold and between the first electrode and the second electrode.

In Example 14, further to the apparatus of Example 13, wherein the antenna is arranged along a top portion of the scaffold assembly.

In Example 15, further to the apparatus of any one of Examples 1-14, the first electrode includes a first area and the second electrode includes a second area, and the first area is substantially equal to the first area.

In Example 16, an apparatus for supporting components of an implantable medical device includes a first electrode and a second electrode; and a scaffold assembly configured to interface with a portion of an implantable medical device and configured to support the first electrode along a first surface of the scaffold assembly and the second electrode along a second surface of the scaffold assembly that opposes the first surface.

In Example 17, further to the apparatus of Example 16, the scaffold assembly is configured to arrange the first electrode parallel to the second electrode.

In Example 18, further to the apparatus of Example 17, the scaffold assembly includes a frontward facing portion and a rearward facing portion, and the first electrode is arranged on the frontward facing portion and the second electrode is arranged on the rearward facing portion.

In Example 19, further to the apparatus of Example 16, the apparatus also includes the implantable medical device having a header, a core assembly including integrated circuitry configured to select between the first electrode and the second electrode.

In Example 20, further to the apparatus of Example 19, the integrated circuitry is configured to measure sensing capability of the first electrode and sensing capability of the second electrode and select between the first electrode and the second electrode in response to determining a greater of the sensing capability of the first electrode and the sensing capability of the second electrode.

In Example 21, further to the apparatus of Example 20, the integrated circuitry is configured to measure impedance on a sensed signal of the first electrode and an impedance on a sensed signal of the second electrode to determine the sensing capability of the first electrode and the sensing capability of the second electrode.

In Example 22, further to the apparatus of Example 19, the first electrode and the second electrode are arranged at a proximal end of the core assembly and further comprising a third electrode arranged at a distal end of the core assembly.

In Example 23, further to the apparatus of Example 22, the integrated circuitry is configured to drive the third electrode and one of the first electrode and the second electrode and to sense another of the first electrode and the second electrode.

In Example 24, further to the apparatus of Example 19, the scaffold assembly is arranged within the header and the scaffold assembly is configured to support and position the first electrode and with a first surface of an interior portion of the header and position the second electrode and with a second surface of the interior portion of the header.

In Example 25, further to the apparatus of Example 16, the apparatus also includes an antenna arranged on the scaffold and between the first electrode and the second electrode.

In Example 26, further to the apparatus of Example 19, the first electrode includes a first area and the second electrode includes a second area, and the first area is substantially equal to the first area.

In Example 27, an apparatus includes a medical device configured to be implanted within a body of a patient including: a core assembly having a proximal end and a distal end, a header coupled to the proximal end of the core assembly, a first electrode and a second electrode arranged within the header, a third electrode arranged at the distal end of the core assembly, and a scaffold assembly arranged within the header and configured to support and separate the first electrode and the second electrode relative to a longitudinal axis of the scaffold assembly.

In Example 28, further to the apparatus of Example 27, the scaffold assembly is configured to interface with a portion of the core assembly and configured to support the first electrode along a first surface of the scaffold assembly and the second electrode along a second surface of the scaffold assembly that opposes the first surface.

In Example 29, further to the apparatus of Example 27, the apparatus also includes integrated circuitry arranged within the core assembly and configured to measure sensing capability of the first electrode and sensing capability of the second electrode and select between the first electrode and the second electrode in response to determining a greater of the sensing capability of the first electrode and the sensing capability of the second electrode.

In Example 30, further to the apparatus of Example 29, the integrated circuitry is configured to measure impedance on a sensed signal of the first electrode and an impedance on a sensed signal of the second electrode to determine the sensing capability of the first electrode and the sensing capability of the second electrode.

In Example 31, further to the apparatus of Example 29, the integrated circuitry is configured to drive the third electrode and one of the first electrode and the second electrode and to sense another of the first electrode and the second electrode.

In Example 32, further to the apparatus of Example 29, the scaffold assembly is arranged within the header and the scaffold assembly is configured to support and position the first electrode and with a first surface of an interior portion of the header and position the second electrode and with a second surface of the interior portion of the header.

In Example 33, a method includes interfacing a scaffold assembly with a core assembly of an implantable medical device; arranging a first circuit component and a second circuit component on portions of the scaffold assembly, the scaffold assembly being configured to position and support the first circuit component relative to the second circuit component; and arranging a header assembly over and around the scaffold assembly and interfacing the header assembly with the core assembly.

In Example 34, further to the method of Example 33, the method also includes electrically connecting the first circuit component and the second circuit component to an integrated circuit arranged within the core assembly.

In Example 35, further to the method of Example 34, electrically connecting the first circuit component and the second circuit component comprises welding the first circuit component and the second circuit to respective electrical connectors coupled to the integrated circuit.

While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the subject matter disclosed herein. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.

While the subject matter disclosed herein is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the subject matter disclosed herein as defined by the appended claims.

Although the term “block” may be used herein to connote different elements illustratively employed, the term should not be interpreted as implying any requirement of, or particular order among or between, various steps disclosed herein unless and except when explicitly referring to the order of individual steps.

DETAILED DESCRIPTION

FIG.1is a schematic illustration of a system100including an implantable medical device (IMD)102implanted within a patient's body104and configured to communicate with a receiving device106. In embodiments, the IMD102may be implanted subcutaneously within an implantation location or pocket in the patient's chest or abdomen and may be configured to monitor (e.g., sense and/or record) physiological parameters associated with the patient's heart108. In embodiments, the IMD102may be an implantable cardiac monitor (ICM) (e.g., an implantable diagnostic monitor (IDM), an implantable loop recorder (ILR), etc.) configured to record physiological parameters such as, for example, one or more cardiac activation signals, heart sounds, blood pressure measurements, oxygen saturations, and/or the like.

In certain instances, the IMD102may be configured to monitor physiological parameters that may include one or more signals indicative of a patient's physical activity level and/or metabolic level, such as an acceleration signal. In certain instances, the IMD102may be configured to monitor physiological parameters associated with one or more other organs, systems, and/or the like. The IMD102may be configured to sense and/or record at regular intervals, continuously, and/or in response to a detected event. In certain instances, such a detected event may be detected by one or more sensors of the IMD102, another IMD (not shown), an external device (e.g., the receiving device106), and/or the like. In addition, the IMD102may be configured to detect a variety of physiological signals that may be used in connection with various diagnostic, therapeutic, and/or monitoring implementations. For example, the IMD102may include sensors or circuitry for detecting respiratory system signals, cardiac system signals, and/or signals related to patient activity. In certain instances, the IMD102may be configured to sense intrathoracic impedance, from which various respiratory parameters may be derived, including, for example, respiratory tidal volume and minute ventilation. Sensors and associated circuitry may be incorporated in connection with the IMD102for detecting one or more body movement or body posture and/or position related signals. For example, accelerometers and/or GPS devices may be employed to detect patient activity, patient location, body orientation, and/or torso position.

For purposes of illustration, and not of limitation, various embodiments of devices that may be used to record physiological parameters in accordance with the present disclosure are described herein in the context of IMDs that may be implanted under the skin in the chest region of a patient.

As shown, the IMD102may include a housing110having two electrodes112and114coupled thereto. According to certain instances, the IMD102may include any number of electrodes (and/or other types of sensors such as, e.g., thermometers, barometers, pressure sensors, optical sensors, motion sensors, and/or the like) in any number of various types of configurations, and the housing110may include any number of different shapes, sizes, and/or features. In certain instances, the IMD102may be configured to sense physiological parameters and record the physiological parameters. For example, the IMD102may be configured to activate (e.g., periodically, continuously, upon detection of an event, and/or the like), record a specified amount of data (e.g., physiological parameters) in a memory, and communicate that recorded data to a receiving device106. In the case of an IDM, for example, the IMD102may activate, record cardiac signals for a certain period of time, deactivate, and activate to communicate the recorded signals to the receiving device106.

In various instances, the receiving device106may be, for example, a programmer, controller, patient monitoring system, and/or the like. Although illustrated inFIG.1as an external device, the receiving device106may include an implantable device configured to communicate with the IMD102that may, for example, be a control device, another monitoring device, a pacemaker, an implantable defibrillator, a cardiac resynchronization therapy (CRT) device, and/or the like, and may be an implantable medical device known in the art or later developed, for providing therapy and/or diagnostic data about the patient and/or the IMD102. In certain instances, the IMD102may be a pacemaker, an implantable cardioverter defibrillator (ICD) device, or a cardiac resynchronization therapy (CRT) device. In certain instances, the IMD102may include both defibrillation and pacing/CRT capabilities (e.g., a CRT-D device).

The system100may be used to implement coordinated patient measuring and/or monitoring, diagnosis, and/or therapy in accordance with embodiments of the disclosure. The system100may include, for example, one or more patient-internal medical devices, such as an IMD102, and one or more patient-external medical devices, such as receiving device106. The receiving device106may be configured to perform monitoring, and/or diagnosis and/or therapy functions external to the patient (i.e., not invasively implanted within the patient's body). The receiving device106may be positioned on the patient, near the patient, or in any location external to the patient.

The IMD102and the receiving device106may communicate through a wireless link. For example, the IMD102and the receiving device106may be coupled through a short-range radio link, such as Bluetooth, IEEE 802.11, and/or a proprietary wireless protocol. The communications link may facilitate uni-directional and/or bi-directional communication between the IMD102and the receiving device106. Data and/or control signals may be transmitted between the IMD102and the receiving device106to coordinate the functions of the IMD102and/or the receiving device106. Patient data may be downloaded from one or more of the IMD102and the receiving device106periodically or on command. The physician and/or the patient may communicate with the IMD102and the receiving device106, for example, to acquire patient data or to initiate, terminate, or modify recording and/or therapy.

The illustrative system100shown inFIG.1is not intended to suggest any limitation as to the scope of use or functionality of embodiments of the subject matter disclosed throughout this disclosure. Neither should the illustrative system100be interpreted as having any dependency or requirement related to any single component or combination of components illustrated inFIG.1. For example, in embodiments, the illustrative system100may include additional components. Additionally, any one or more of the components depicted inFIG.1can be, in embodiments, integrated with various ones of the other components depicted therein (and/or components not illustrated). Any number of other components or combinations of components can be integrated with the illustrative system100depicted inFIG.1, all of which are considered to be within the ambit of this disclosure.

FIG.2Ais a front-facing view of a header200and scaffold assembly202. The scaffold assembly202may be an apparatus for supporting components of an implantable medical device (e.g., as shown inFIG.1andFIGS.4A-B). The scaffold assembly202may be configured to support and separate a first electrode204and a second electrode206relative to a longitudinal axis208of the scaffold assembly202.

In certain instances, the scaffold assembly202is configured to support the first electrode204along a first surface210of the scaffold assembly202and the second electrode206along a second surface212of the scaffold assembly202that opposes the first surface210. The first surface210may be a frontward facing portion and the second surface212may be a rearward facing portion of the scaffold assembly202as shown inFIG.2AandFIG.2B. In other instances, the first surface210and the second surface212may be sides of the scaffold assembly202. The scaffold assembly may be configured to arrange the first electrode202parallel to the second electrode204.

FIG.2Bis a back-facing view of the header200and the scaffold assembly202shown inFIG.2A. The header200includes an exterior surface200A that encloses an interior region200B. The header202may house various circuitry components within the interior region200B such as the first electrode204and the second electrode206. The exterior surface200A may contact a patient's bodily tissue when an IMD, that includes the header200, is subcutaneously implanted in an implantation location or pocket in the patient's chest or abdomen. The interior region200B of the header200may provide a space and house the scaffold assembly202and circuit components positioned and supported by the scaffold assembly202. In order to enable sensing of physiological parameters within the patient, the first electrode204and the second electrode206may be positioned to be flush with the interior region200B of the header200. In other instances, the first electrode204and the second electrode206may be positioned by the scaffold assembly202to form a portion of the exterior surface200A of the header202.

FIG.3Ais a front-facing view of a header300, scaffold assembly302, and core assembly314andFIG.3Bis a back-facing view of the header200and the scaffold assembly302, and the core assembly314shown inFIG.3A. The scaffold assembly302includes a first surface310and a second surface312.FIG.3Aalso shows a portion of a core assembly314. The header300, scaffold assembly302, and core assembly314may form portions of an IMD (e.g., as shown inFIG.1andFIGS.4A-B). The scaffold assembly304may form a part of an apparatus for supporting components of the IMD. As such, an end portion and a portion of an intermediate section of the core assembly314is shown inFIG.3A. Further, additional elements of the IMD may be included at the other end portion of the core assembly314(not shown). These elements may include a battery and an electrode.

The scaffold assembly302may be configured to support and position one or more circuit components. The scaffold assembly302, for example, may be configured to interface with a portion of the IMD and configured to support the first electrode304along the first surface310of the scaffold assembly302and a second electrode306along the second surface312of the scaffold assembly302. In certain instances, the second surface312of the scaffold assembly302opposes the first surface310. In addition, the scaffold assembly302may be configured to arrange the first electrode304parallel to the second electrode306.

In certain instances, the core assembly314includes integrated circuitry316. The core assembly314may include one or more conduits that provide a feedthrough for at least one electrical connector or interconnect. As shown inFIG.3B, interconnects318,320,322are provided and feed through the conduits to connect the first electrode304and the second electrode306to the integrated circuitry316. In certain instances, the scaffold assembly302may also support an antenna324. In these instances, one of the interconnects318,320,322may connect the antenna324to the integrated circuitry316.

The functionality of the first electrode304and the second electrode306may be controlled by the integrated circuitry316. For example, the integrated circuitry316may be configured to select between the first electrode304and the second electrode306. In addition, the integrated circuitry316may be configured to measure sensing capability of the first electrode304and sensing capability of the second electrode306. In certain instances, the integrated circuitry316may be configured to select between the first electrode304and the second electrode306in response to determining which of the first electrode304and the second electrode306has a greater of the sensing capability. The integrated circuitry316may be configured to measure impedance on a sensed signal of the first electrode304and an impedance on a sensed signal of the second electrode306to determine the sensing capability of the first electrode304and the sensing capability of the second electrode306.

The scaffold assembly302supporting and arranging the first electrode304and the second electrode306may reduce sensing noise when impedance is measured (as compared to a device having a single electrode in a header). In addition, the integrated circuitry316being configured to select between the first electrode304and the second electrode306may increasing sensing capabilities and signal capture as compared to a device having a single electrode within a header. As noted above The scaffold assembly304may form a part of an apparatus for supporting components of an IMD. When implanted, the IMD may turn or flip which may affect sensing capability of the IMD. The integrated circuitry316being configured to select between the first electrode304and the second electrode306allows for selecting of whichever of the first electrode304and the second electrode306has the stronger signal for sensing.

During the impedance measurement, the integrated circuitry316may be configured to drive a signal to one of the first electrode304and the second electrode306while sensing on the other of the first electrode304and the second electrode306. In these instances, the integrated circuitry316may drive the signals to the first electrode304and the second electrode306in a loop to isolate the sensed signals.

In certain instances, functionality of the circuitry components supported and arranged by the scaffold assembly302may depend on the arrangement or positioning of the circuitry components. More specifically, unintended or uncontrolled movement of one or more circuitry components, such as the first electrode304and the second electrode306, may disconnect from integrated circuitry316. In addition, the scaffold assembly302facilitates arranging the first electrode304and the second electrode306to ensure that the first electrode304and the second electrode306are arranged on opposite sides of the IMD to facilitate sensing.

In addition, the functionality of antenna324may also controlled by integrated circuitry316housed within the core assembly314. The scaffold assembly302may center the antenna324between the first electrode304and the second electrode306. In this manner, the scaffold assembly302may facilitate performance of the antenna324and avoid RF interference by keeping the antenna324from muscle tissue and closer to the skin side (e.g., exterior side of a patient's body) of the header300so there is less body tissue to transmit through.

The illustrative components shown inFIG.3AandFIG.3Bare not intended to suggest any limitation as to the scope of use or functionality of embodiments of the disclosed subject matter. Neither should the illustrative components be interpreted as having any dependency or requirement related to any single component or combination of components illustrated therein. Additionally, any one or more of the components depicted inFIG.4AandFIG.4B(discussed in further detail below) may be, in embodiments, integrated with various other components depicted therein (and/or components not illustrated), all of which are considered to be within the ambit of the disclosed subject matter.

FIG.4Ais a front-facing view of an IMD400andFIG.4Bis a back-facing view of the IMD. The IMD may be, or may be similar to, the IMD102depicted inFIG.1. The scaffold assembly402includes a first surface410and a second surface412. The scaffold assembly404may form a part of an apparatus for supporting components of the IMD. The IMD also includes a core assembly414, which may house integrated circuitry (not shown) internal to the core assembly414. The core assembly414also includes a battery426and a third electrode428.

The scaffold assembly402may be configured to support and position one or more circuit components. The scaffold assembly402is configured to interface with a portion of the core assembly414(e.g., as shown inFIGS.3A-B). The scaffold assembly402may be configured to support and separate a first electrode404and a second electrode406relative to a longitudinal axis of the scaffold assembly402. The scaffold assembly402may be configured to support the first electrode404along the first surface410of the scaffold assembly402and a second electrode406along the second surface412of the scaffold assembly402. In certain instances, the second surface412of the scaffold assembly402opposes the first surface410. In addition, the scaffold assembly402may be configured to arrange the first electrode404parallel to the second electrode406. In addition, the first electrode404may include a first area and the second electrode406includes a second area that is substantially equal to the first area.

The functionality of the first electrode404, the second electrode406, and the third electrode428may be controlled by the integrated circuitry. In certain instances, the integrated circuitry may be configured to select between the first electrode404and the second electrode406. In addition, the integrated circuitry may be configured to measure sensing capability of the first electrode404and sensing capability of the second electrode406. In certain instances, the integrated circuitry may be configured to select between the first electrode404and the second electrode406in response to determining which of the first electrode404and the second electrode406has a greater of the sensing capability.

The integrated circuitry may be configured to measure impedance on a sensed signal of the first electrode404and an impedance on a sensed signal of the second electrode406to determine the sensing capability of the first electrode404and the sensing capability of the second electrode406. In certain instances, the integrated circuitry is configured to drive the third electrode428and one of the first electrode404and the second electrode406and to sense another of the first electrode404and the second electrode406. In addition, the integrated circuitry includes a Kelvin connection to the first electrode404and the second electrode406.

In certain instances, the core assembly414may include an accelerometer to determine whether or not the IMD has turned or flipped. The accelerometer may determine periods of electrode inactivity to determine a stable signal and select between the first electrode404and the second electrode406.

The scaffold assembly402supporting and arranging the first electrode404and the second electrode406may reduce sensing noise when impedance is measured (as compared to a device having a single electrode in a header). In addition, the integrated circuitry being configured to select between the first electrode404and the second electrode406may increasing sensing capabilities and signal capture as compared to a device having a single electrode within a header. As noted above, the scaffold assembly404may form a part of an apparatus for supporting components of an IMD. When implanted, the IMD may turn or flip which may affect sensing capability of the IMD. The integrated circuitry being configured to select between the first electrode404and the second electrode406allows for selecting of whichever of the first electrode404and the second electrode406has the stronger signal for sensing.

In certain instances, the scaffold assembly402may also support an antenna424. In addition, interconnects may connect the antenna424to the integrated circuitry. The antenna424may be arranged along a top surface of the scaffold assembly402. In addition, the functionality of antenna424may also controlled by integrated circuitry housed within the core assembly414. The scaffold assembly302may center the antenna424between the first electrode404and the second electrode406. In this manner, the scaffold assembly402may facilitate performance of the antenna424and avoid RF interference by keeping the antenna324from muscle tissue and closer to the skin side (e.g., exterior side of a patient's body) of the header400so there is less body tissue to transmit through.