Patent Description:
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 be implanted subcutaneously in a patient such as, for example, in a tissue pocket of the chest region. Conventional IMDs may undergo unwanted migration within the patient after implantation. Additionally, the relatively smooth external surface of conventional IMDs can frustrate the ability to grip the IMD with a medical forceps, thus making extraction of the IMD difficult. Document <CIT> describes an implantable medical device comprising protrusions.

It relates to an implantable medical device as described in claim <NUM>, and to a method of forming an implantable medical device as described in claim <NUM>. Advantageous embodiments can be found in the dependent claims. The following examples form part of the present disclosure, and may be helpful for understanding the invention.

In an Example <NUM>, an implantable medical device comprising: a housing having an outer surface; and a plurality of protrusions extending from the outer surface, wherein the plurality of protrusions are configured to reduce at least one of rotational, translational, and lateral movement of the implantable medical device within a patient's tissue after implantation in the patient.

In an Example <NUM>, the implantable medical device of Example <NUM>, further comprising: a core assembly comprising a core assembly housing, the core assembly having a first end and a second end; and a header coupled at a first header end to the first end of the core assembly housing, the header comprising a header housing having an outer surface extending from the first header end to a second header end.

In an Example <NUM>, the implantable medical device of Example <NUM>, wherein the plurality of protrusions extends from the outer surface of the header housing.

In an Example <NUM>, the implantable medical device of Example <NUM>, wherein the outer surface of the header housing includes a first side and a second, opposite-facing, side, the plurality of protrusions comprising a plurality of rows of protrusions, each row extending at least partially across a width of the first side, wherein each of the plurality of rows of protrusions includes at least one protrusion.

In an Example <NUM>, the implantable medical device of Example <NUM>, the plurality of protrusions comprising at least one additional row of protrusions disposed on the second side.

In an Example <NUM>, the implantable medical device of either of Examples <NUM> or <NUM>, wherein each of the plurality of rows of protrusions is oriented parallel to a first axis, wherein the first axis is perpendicular to a second axis, the second axis comprising an axis of symmetry of the header, extending from the first header end to the second header end.

In an Example <NUM>, the implantable medical device of any of Examples <NUM>-<NUM>, wherein each of the plurality of rows of protrusions is arranged to be offset from an adjacent row of protrusions.

In an Example <NUM>, the implantable medical device of either of Examples <NUM> or <NUM>, further comprising an elongated protrusion oriented at an angle to the second axis.

In an Example <NUM>, the implantable medical device of any of Examples <NUM>-<NUM>, wherein at least one protrusion of the plurality of protrusions has an elongated truncated pyramid shape.

In an Example <NUM>, the implantable medical device of any of Examples <NUM>-<NUM>, wherein at least one protrusion of the plurality of protrusions has a truncated triangular prism shape.

In an Example <NUM>, the implantable medical device of any of Examples <NUM>-<NUM>, wherein the plurality of protrusions are shaped to provide a complementary fit to a plurality of teeth of a medical forceps.

In an Example <NUM>, a method of forming an implantable medical device, the method comprising: forming a core assembly comprising a core assembly housing, the core assembly having an outer surface extending between a first end and a second end; forming a header, the header comprising a header housing having an outer surface extending from a first header end to a second header end; forming a plurality of protrusions disposed on the outer surface of the header housing; and coupling the header, at a second header end, to the first end of the core assembly housing.

In an Example <NUM>, the method of Example <NUM>, wherein the outer surface of the header housing includes a first side and a second, opposite-facing, side, and wherein forming the plurality of protrusions comprises forming a plurality of rows of protrusions, each row extending at least partially across a width of the first side, wherein each of the plurality of rows of protrusions includes at least one protrusion, wherein each of the plurality of rows of protrusions is aligned parallel to a first axis, and wherein the first axis is perpendicular to a second axis, the second axis comprising an axis of symmetry of the header, extending from the first header end to the second header end.

In an Example <NUM>, the method of Example <NUM>, wherein forming the plurality of protrusions further comprises forming an elongated protrusion oriented at an angle to the second axis.

In an Example <NUM>, the method of any of Examples <NUM>-<NUM>, wherein forming the plurality of protrusions comprises shaping the plurality of protrusions to provide a complementary fit to a plurality of teeth of a standard medical forceps.

In an Example <NUM>, an implantable medical device comprising: a core assembly housing having an outer surface; a header housing coupled to the core assembly housing, the header housing having an outer surface extending from a first header end to a second header end; and a plurality of protrusions disposed on at least one of the outer surface of the header housing and the outer surface of the core assembly housing, wherein at least one of the plurality of protrusions has at least one of an elongated shape and an edge.

In an Example <NUM>, the implantable medical device of Example <NUM>, wherein each of the plurality of rows of protrusions is aligned parallel to a first axis, wherein the first axis is perpendicular to a second axis, the second axis comprising an axis of symmetry of the header, extending from the first header end to the second header end.

In an Example <NUM>, the implantable medical device of Example <NUM>, wherein each of the plurality of rows of protrusions is arranged to be offset from an adjacent row of protrusions.

In an Example <NUM>, the implantable medical device of Example <NUM>, further comprising an elongated protrusion oriented at an angle to the second axis.

In an Example <NUM>, the implantable medical device of Example <NUM>, wherein at least one protrusion of the plurality of protrusions has an elongated truncated pyramid shape.

In an Example <NUM>, the implantable medical device of Example <NUM>, wherein at least one protrusion of the plurality of protrusions has a truncated triangular prism shape.

In an Example <NUM>, the implantable medical device of Example <NUM>, wherein the plurality of protrusions are shaped to provide a complementary fit to a plurality of teeth of a medical forceps.

In an Example <NUM>, the implantable medical device of Example <NUM>, wherein the protrusions are configured to reduce at least one of rotational, translational, and lateral movement of the implantable medical device within a patient's tissue after implantation in the patient.

In an Example <NUM>, an implantable medical device comprising: a core assembly comprising a core assembly housing, the core assembly having a first end and a second end; a header coupled at a first header end to the first end of the core assembly housing, the header comprising a header housing having an outer surface extending from the first header end to a second header end; and a plurality of protrusions disposed on the outer surface of the header housing, wherein at least one of the plurality of protrusions has at least one of an elongated shape and an edge.

In an Example <NUM>, the implantable medical device of Example <NUM>, wherein the outer surface of the header housing includes a first side and a second, opposite-facing, side, the plurality of protrusions comprising a plurality of rows of protrusions, each row extending at least partially across a width of the first side, wherein each of the plurality of rows of protrusions includes at least one protrusion, wherein each of the plurality of rows of protrusions is aligned parallel to a first axis, and wherein the first axis is perpendicular to a second axis, the second axis comprising an axis of symmetry of the header, extending from the first header end to the second header end.

In an Example <NUM>, a method of forming an implantable medical device, the method comprising: forming a core assembly comprising a core assembly housing, the core assembly having an outer surface extending between a first end and a second end; forming a header, the header comprising a header housing having an outer surface extending from a first header end to a second header end; forming a plurality of protrusions disposed on the outer surface of the header housing, wherein at least one of the plurality of protrusions has at least one of an elongated shape and an edge; and coupling the header, at a first header end, to the first end of the core assembly housing.

In an Example <NUM>, the method of Example <NUM>, wherein at least one protrusion of the plurality of protrusions has at least one of an elongated truncated pyramid shape and a truncated triangular prism shape.

In an Example <NUM>, the method of Example <NUM>, wherein forming the plurality of protrusions comprises shaping the plurality of protrusions to provide a complementary fit to a plurality of teeth of a standard medical forceps.

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 disclosure.

While the disclosed subject matter 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 disclosed subject matter to the particular embodiments described. On the contrary, the disclosed subject matter is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosed subject matter as defined by the appended claims.

As the terms are used herein with respect to ranges of measurements (such as those disclosed immediately above), "about" and "approximately" may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement, but that may differ by a reasonably small amount such as will be understood, and readily ascertained, by individuals having ordinary skill in the relevant arts to be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, adjustments made to optimize performance and/or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like.

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.

<FIG> is a schematic illustration of a system <NUM> including an implantable medical device (IMD) <NUM> implanted within a patient's body <NUM> and configured to communicate with a receiving device <NUM>. In embodiments, the IMD <NUM> may 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 heart <NUM>. In some embodiments, the IMD <NUM> may 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 some embodiments, the IMD <NUM> may 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 some embodiments, the IMD <NUM> may be configured to monitor physiological parameters associated with one or more other organs, systems, and/or the like. The IMD <NUM> may be configured to sense and/or record at regular intervals, continuously, and/or in response to a detected event. In embodiments, such a detected event may be detected by one or more sensors of the IMD <NUM>, another IMD (not shown), an external device (e.g., the receiving device <NUM>), and/or the like. In addition, the IMD <NUM> may 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 IMD <NUM> may include sensors or circuitry for detecting respiratory system signals, cardiac system signals, and/or signals related to patient activity. In embodiments, the IMD <NUM> may 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 IMD <NUM> for 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. In embodiments, however, the IMD <NUM> may include any type of IMD, any number of different components of an implantable system, and/or the like having a housing and being configured to be implanted in a patient's body <NUM>. For example, the IMD <NUM> may include a control device, a monitoring device, a pacemaker, an implantable cardioverter defibrillator (ICD), 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's body and/or the IMD <NUM>. In various embodiments, the IMD <NUM> may include both defibrillation and pacing/CRT capabilities (e.g., a CRT-D device).

As shown, the IMD <NUM> may include a housing <NUM> having two electrodes <NUM> and <NUM> coupled thereto. According to embodiments, the IMD <NUM> may 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 housing <NUM> may include any number of different shapes, sizes, and/or features. In embodiments, the IMD <NUM> may be configured to sense physiological parameters and record the physiological parameters. For example, the IMD <NUM> may 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 device <NUM>. In the case of an IDM, for example, the IMD <NUM> may activate, record cardiac signals for a certain period of time, deactivate, and activate to communicate the recorded signals to the receiving device <NUM>.

In various embodiments, the receiving device <NUM> may be, for example, a programmer, controller, patient monitoring system, and/or the like. Although illustrated in <FIG> as an external device, the receiving device <NUM> may include an implantable device configured to communicate with the IMD <NUM> that 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 IMD <NUM>. In various embodiments, the IMD <NUM> may be a pacemaker, an implantable cardioverter defibrillator (ICD) device, or a cardiac resynchronization therapy (CRT) device. In various embodiments, the IMD <NUM> may include both defibrillation and pacing/CRT capabilities (e.g., a CRT-D device).

The system <NUM> may be used to implement coordinated patient measuring and/or monitoring, diagnosis, and/or therapy in accordance with embodiments of the disclosure. The system <NUM> may include, for example, one or more patient-internal medical devices, such as an IMD <NUM>, and one or more patient-external medical devices, such as receiving device <NUM>. In embodiments, the receiving device <NUM> may 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 device <NUM> may be positioned on the patient, near the patient, or in any location external to the patient.

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

The illustrative system <NUM> shown in <FIG> is 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 system <NUM> be interpreted as having any dependency or requirement related to any single component or combination of components illustrated in <FIG>. For example, in embodiments, the illustrative system <NUM> may include additional components. Additionally, any one or more of the components depicted in <FIG> can 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 system <NUM> depicted in <FIG>, all of which are considered to be within the ambit of this disclosure.

<FIG> is an upper view of an implantable medical device (IMD) <NUM>, and <FIG> is a lower perspective view of the IMD <NUM>, in accordance with embodiments of the disclosure. The IMD <NUM> may be, or may be similar to, the IMD <NUM> depicted in <FIG>. As shown in <FIG>, the IMD <NUM> has a header <NUM>, a core assembly <NUM>, a battery assembly <NUM>, and an electrode assembly <NUM>.

As shown in <FIG>, the IMD <NUM> may have an elongated shape having a first end <NUM> and a second end <NUM>. The IMD <NUM> includes a first side <NUM> and a second side <NUM>. The IMD <NUM> may include a central axis <NUM> of symmetry extending along the length of the IMD <NUM>. The IMD <NUM> includes a first surface <NUM> defined between the first end <NUM> and the second end <NUM> and between the first side <NUM> and the second side <NUM>, and a second surface <NUM> that is opposite the first surface <NUM>. In embodiments, the first surface <NUM> and/or the second surface <NUM> may be at least approximately planar, and the first surface <NUM> may be at least approximately parallel to the second surface <NUM>. That is, for example, the first surface <NUM> may be disposed in a first plane and the second surface <NUM> may be disposed in a second plane that is parallel to the first plane. In embodiments, a second axis <NUM> may be defined perpendicular to the central axis <NUM>, and disposed in a plane that is parallel to each of the first and second surfaces <NUM> and <NUM>.

As shown in <FIG>, the IMD <NUM> has a third surface <NUM> extending along the perimeter of the IMD <NUM> and oriented at least approximately perpendicularly to the first and second surfaces <NUM> and <NUM>. As shown, the third surface <NUM> includes the first and second sides <NUM> and <NUM> of the IMD <NUM>. A fourth, curved, surface <NUM> extends along the perimeter of the IMD <NUM> and between the first surface <NUM> and the third surface <NUM>. A fifth, curved, surface <NUM> extends along the perimeter of the IMD <NUM> and between the second surface <NUM> and the third surface <NUM>.

In the embodiments shown in <FIG>, the first surface <NUM> and second surface <NUM> are at least approximately planar and at least approximately rectangular, having rounded corners, and the third surface <NUM> is at least approximately planar along the first <NUM> and the second side <NUM>. In embodiments, the first surface <NUM> and/or second surface <NUM> may be at least approximately elliptical, may be curved (as opposed to planar), may have unrounded corners, or may be defined according to any number of other shapes. Similarly, in embodiments, the third surface <NUM>, fourth surface <NUM>, and/or fifth surface <NUM> may be rounded (e.g., convex or concave), at least approximately planar, or may be defined according to any number of other shapes. The first surface <NUM>, second surface <NUM>, third surface <NUM>, fourth surface <NUM>, and fifth surface <NUM>, define an outer surface <NUM> of the IMD <NUM>. In embodiments, the outer surface <NUM> of the IMD <NUM> may be defined according to any number of different shapes.

As shown in <FIG>, in embodiments, the header <NUM> (which is illustrated as being transparent) is arranged at or near the first end <NUM> of the IMD <NUM>, and includes a first end <NUM> and a second end <NUM>. The header <NUM> includes a header housing <NUM> that encloses an interior region <NUM>. As shown, an external surface <NUM> of the header housing <NUM> forms a portion of the outer surface <NUM> of the IMD <NUM>. That is, for example, a portion of one or more of the first surface <NUM>, the second surface <NUM>, the third surface <NUM>, the fourth surface <NUM>, and the fifth surface <NUM> may be provided by the external surface <NUM> of the header housing <NUM>. The header <NUM> may house various circuitry components within its interior region <NUM> (e.g., an electrode <NUM> and an antenna <NUM>) positioned and supported by a scaffold assembly <NUM>. In some embodiments, the first end <NUM> of the header <NUM> forms the first end <NUM> of the IMD <NUM>.

The core assembly <NUM> includes core circuitry enclosed within a core assembly housing <NUM>, and includes a first end <NUM> and a second end <NUM>. The first end <NUM> of the core assembly <NUM> is coupled to the second end <NUM> of the header <NUM>. In embodiments, the core assembly <NUM> may be coupled to the header <NUM> via a feed-through assembly <NUM>, which may be configured to provide a throughput for connections configured to connect the circuitry components of the header <NUM> to the core circuitry disposed within the core assembly <NUM>. As shown, an external surface <NUM> of the core assembly housing <NUM> forms a portion of the outer surface <NUM> of the IMD <NUM>. That is, for example, a portion of one or more of the first surface <NUM>, the second surface <NUM>, the third surface <NUM>, the fourth surface <NUM>, and the fifth surface <NUM> may be provided by the external surface <NUM> of the core assembly housing <NUM>. Additionally, an external surface <NUM> of the feed-through assembly <NUM> may form a portion of the outer surface <NUM> of the IMD <NUM>.

The battery assembly <NUM> (which may include one or more batteries) includes a first end <NUM> coupled to the second end <NUM> of the core assembly <NUM>, and a second end <NUM>. In embodiments, the battery assembly <NUM> may be coupled to the core assembly <NUM> via a feed-through assembly <NUM>, which may be configured to provide a throughput for connections configured to connect the circuitry components of the core assembly <NUM> to the one or more batteries disposed within the battery assembly <NUM>. The battery assembly <NUM> includes a battery assembly housing <NUM>, and, as shown, an external surface <NUM> of the battery assembly housing <NUM> forms a portion of the outer surface <NUM> of the IMD <NUM>. That is, for example, a portion of one or more of the first surface <NUM>, the second surface <NUM>, the third surface <NUM>, the fourth surface <NUM>, and the fifth surface <NUM> may be provided by the external surface <NUM> of the battery assembly housing <NUM>. Additionally, an external surface <NUM> of the feed-through assembly <NUM> may form a portion of the outer surface <NUM> of the IMD <NUM>.

As shown, the electrode assembly <NUM> may form the second end <NUM> of the IMD <NUM>, and may be coupled to the second end <NUM> of the battery assembly <NUM>. The electrode assembly <NUM> may include a first end <NUM> and a second end <NUM>. The electrode assembly <NUM> includes an electrode assembly housing <NUM>, and, as shown, an external surface <NUM> of the electrode assembly housing <NUM> forms a portion of the outer surface <NUM> of the IMD <NUM>. That is, for example, a portion of one or more of the first surface <NUM>, the second surface <NUM>, the third surface <NUM>, the fourth surface <NUM>, and the fifth surface <NUM> may be provided by the external surface <NUM> of the electrode assembly housing <NUM>. According to embodiments, the external surface <NUM> of the electrode assembly housing <NUM> may be, or include, an electrode. In embodiments, the electrode assembly <NUM> may be an electrode that is disposed over an end portion of the battery assembly housing <NUM>, which may extend to the second end <NUM> of the IMD <NUM>.

As shown in <FIG>, the outer surface <NUM> of the IMD <NUM> may incorporate or include additional features and structures such as, for example, protrusions <NUM> configured to inhibit migration of the IMD <NUM> within the patient's body, to facilitate gripping of the IMD <NUM> with a medical forceps, and/or the like. For example, the outer surface <NUM> of the IMD <NUM> may include any number of different types of protrusions <NUM> oriented in any number of different configurations, and having any number of different shapes. In the embodiments shown in <FIG>, for example, protrusions <NUM> are disposed on the first surface <NUM> and the second surface <NUM>. In embodiments, the IMD <NUM> may include one or more protrusions <NUM> at any other location or locations on the outer surface <NUM> of the IMD <NUM> such as, for example, on the first surface <NUM>, the second surface <NUM>, the third surface <NUM>, the fourth surface <NUM>, and/or the fifth surface <NUM>.

According to embodiments, the IMD <NUM> may include at least one protrusion that has an elongated shape, as described herein, or includes at least one edge. That is, for example, the IMD <NUM> may include at least one protrusion that has an irregular shape, an elliptical shape, a rectangular shape, a triangular shape, and/or the like. The edge may include any type of intersection between two surfaces that may not be rounded, and may include a dull edge, a sharp edge, a beveled edge, a stepped edge, and/or the like. The edge may be characterized by any number of different angles of intersection, and may include a round edge (e.g., an edge at the intersection of a wall and a base of a truncated conical prism).

As depicted in <FIG>, a first set 284A of protrusions <NUM> is disposed on the first surface <NUM> (on the external surface <NUM> of the header housing <NUM>), near the second end <NUM> of the header <NUM>; and a second set 284B of protrusions <NUM> is disposed on the first surface <NUM> (on the external surface <NUM> of the header housing <NUM>), near the first end <NUM> of the header <NUM>. Similarly, a third set 286A of protrusions <NUM> is disposed on the second surface <NUM> (on the external surface <NUM> of the header housing <NUM>), near the second end <NUM> of the header <NUM>; and a fourth set 286B of protrusions <NUM> is disposed on the second surface <NUM> (on the external surface <NUM> of the header housing <NUM>), near the first end <NUM> of the header <NUM>. According to embodiments, the first set 284A, second set 284B, third set 286A, and fourth set 286B of protrusions <NUM> each may include one or more protrusions <NUM> arranged in proximity to each other and oriented in any number of different configurations. Additionally, or alternatively, the IMD <NUM> may include any number of sets of protrusions (e.g., one set of protrusions, two sets of protrusions, three sets of protrusions, five sets of protrusions, etc.).

As shown, for example, the first set 284A of protrusions <NUM> includes three rows of protrusions <NUM>, each row extending at least partially across a width of the first surface <NUM>, and oriented perpendicularly to the first axis <NUM> (and, e.g., parallel to the second axis <NUM>). A first row (e.g., the row closest to the first end <NUM> of the IMD <NUM>) of the first set 284A of protrusions <NUM> includes three protrusions <NUM>, a second row (e.g., the row adjacent the first row) includes two protrusions <NUM>, and a third row (e.g., the row farthest from the first end <NUM> of the IMD <NUM>) includes three protrusions <NUM>. The second row is offset from the first and third rows. In other embodiments, the rows may not be offset, thereby forming a number of columns, which may, for example, be oriented parallel to the first axis <NUM>. In embodiments, the first set 284A of protrusions <NUM> may include any number of rows and/or columns, any number of offset rows, and/or the like. Additionally, each row and/or column of protrusions <NUM> of the first set 284A may include any number of protrusions <NUM> (e.g., one protrusion, two protrusions, three protrusions, four protrusions, etc.). Although all of the protrusions <NUM> of the first set 284A of protrusions are illustrated as having the same size, shape, and orientation, in embodiments, any one or more of the size, shape, and orientation of protrusions <NUM> within a set, row, and/or column, may include any number of variances.

The second set 284B of protrusions <NUM> includes two protrusions <NUM>, each protrusion <NUM> oriented differently than the other, and each protrusion <NUM> oriented differently than the protrusions <NUM> in the first set 284A. In embodiments, the second set 284B of protrusions <NUM> may include any number of rows and/or columns, any number of offset rows, and/or the like. Additionally, each row and/or column of protrusions <NUM> of the second set 284B may include any number of protrusions <NUM> (e.g., one protrusion, two protrusions, three protrusions, four protrusions, etc.).

As shown, for example, the third set 286A of protrusions <NUM> includes two rows of protrusions <NUM>, each row extending at least partially across a width of the second surface <NUM>, and oriented perpendicularly to the first axis <NUM> (and, e.g., parallel to the second axis <NUM>). A first row (e.g., the row closest to the first end <NUM> of the IMD <NUM>) of the third set 286A of protrusions <NUM> includes two protrusions <NUM>, and a second row (e.g., the row adjacent the first row) includes three protrusions <NUM>. The second row is offset from the first row. In other embodiments, the rows may not be offset, thereby forming a number of columns, which may, for example, be oriented parallel to the first axis <NUM>. In embodiments, the third set 286A of protrusions <NUM> may include any number of rows and/or columns, any number of offset rows, and/or the like. Additionally, each row and/or column of protrusions <NUM> of the third set 286A may include any number of protrusions <NUM> (e.g., one protrusion, two protrusions, three protrusions, four protrusions, etc.). Although all of the protrusions <NUM> of the third set 286A of protrusions are illustrated as having the same size, shape, and orientation, in embodiments, any one or more of the size, shape, and orientation of protrusions <NUM> within a set, row, and/or column, may include any number of variances.

The fourth set 286B of protrusions <NUM> includes two protrusions <NUM>, each protrusion <NUM> oriented differently than the other, and each protrusion <NUM> oriented differently than the protrusions <NUM> in the third set 286A. In embodiments, the fourth set 286B of protrusions <NUM> may include any number of rows and/or columns, any number of offset rows, and/or the like. Additionally, each row and/or column of protrusions <NUM> of the fourth set 286B may include any number of protrusions <NUM> (e.g., one protrusion, two protrusions, three protrusions, four protrusions, etc.).

According to various embodiments, protrusions may be arranged in rows that are aligned to form multiple longitudinal columns of at least two protrusions. As shown in <FIG>, the protrusions may be arranged in multiple rows, where each row is offset from an adjacent row. In embodiments, a set of protrusions may include a number of rows, with each of the rows of protrusions aligned at least approximately perpendicular to the central axis <NUM>, at least approximately parallel to the central axis <NUM>, and/or at an angle to the central axis <NUM>. Any other arrangement of protrusions, rows of protrusions, columns of protrusions, and/or the like, may be implemented in accordance with embodiments of the disclosure. The protrusions may be formed according to any number of different shapes. For example, each protrusion may have a triangular cross sectional shape, having for example a widened base attached to the outer surface <NUM> of the IMD <NUM> and a narrowed apex, truncated side, or peak. In embodiments, each protrusion may have a truncated pyramid shape, a truncated triangular prism shape, a block shape, a cylindrical shape, or any three dimensional shape. In embodiments, each protrusion may have any number of different sizes, and in embodiments, the protrusions may be sized to fit within the grip of a medical forceps, as shown, for example, in <FIG>.

<FIG> is a side view of a portion of an IMD <NUM> being gripped by a portion of a medical forceps <NUM>, in accordance with embodiments of the disclosure. The IMD <NUM> may be, be identical to, or be similar to, the IMD <NUM> depicted in <FIG> and/or the IMD <NUM> depicted in <FIG>. As shown, for example, in <FIG>, the IMD <NUM> includes a header <NUM> having a first end <NUM> and a second end <NUM>. The second end <NUM> of the header <NUM> is coupled, via a feed-through assembly <NUM> to a core assembly <NUM>. As shown in <FIG>, the IMD <NUM> includes an outer surface <NUM>, which includes a first surface <NUM> and a second, opposite and parallel, surface <NUM>.

A first set <NUM> of protrusions <NUM> is disposed on the first surface <NUM> near the second end <NUM> of the header <NUM>; a second set <NUM> of protrusions <NUM> is disposed on the first surface <NUM> near the first end <NUM> of the header; a third set <NUM> of protrusions <NUM> is disposed on the second surface <NUM> near the second end <NUM> of the header; and a fourth set <NUM> of protrusions <NUM> is disposed on the second surface <NUM> near the first end <NUM> of the header <NUM>. As shown, the protrusions <NUM>, <NUM>, <NUM>, and <NUM> are shaped and arranged to correspond to the shape and arrangement, respectively, of the teeth <NUM> of the medical forceps <NUM>. For example, the width of each protrusion may be sized to fit within each of the spaces in the grips of a medical forceps; and the height of each protrusion may be sized to be received a distance into the grip of a medical forceps. In embodiments, the protrusions <NUM>, <NUM>, <NUM>, and <NUM> may be sized with a complementary height, length, and/or width to the teeth <NUM> of a standard medical forceps, a custom medical forceps, and/or the like. In embodiments, the protrusions <NUM>, <NUM>, <NUM>, and <NUM> may be configured in different sizes so that at least one of the protrusions <NUM>, <NUM>, <NUM>, and <NUM> corresponds to one of several different styles, sizes, and/or shapes of forceps. In embodiments, for example, the protrusions maybe shaped to correspond to a medical forceps having a grid patterned grip, a checkered grip, a number of rows of teeth, and/or any suitable pattern for gripping or holding.

<FIG> is a top view of a header <NUM> of an IMD <NUM>, in accordance with embodiments of the disclosure. The IMD <NUM> may be, be identical to, or be similar to, the IMD <NUM> depicted in <FIG>, the IMD <NUM> depicted in <FIG>, and/or the IMD <NUM> depicted in <FIG>. A central axis <NUM> of symmetry extends along the length of the IMD <NUM>, from a first end <NUM> of the header <NUM> to a second end <NUM> of the header <NUM>, as shown.

A first set <NUM> of protrusions <NUM> is arranged, on a first surface <NUM> (which forms a portion of an outer surface of the IMD <NUM>), near the second end <NUM> of the header <NUM>. As shown in <FIG>, the first set <NUM> of protrusions <NUM> is arranged in three rows <NUM>, <NUM>, and <NUM>. Each row <NUM>, <NUM>, and <NUM> is oriented perpendicular to the central axis <NUM> and extends partially across a width <NUM> of the header <NUM>, defined between a first side <NUM> and a second side <NUM>. The first row <NUM> includes three protrusions <NUM>, the second row <NUM> includes two protrusions <NUM>, and the third row <NUM> includes three protrusions <NUM>. The second row <NUM> is offset from the first and third rows <NUM> and <NUM>. In other embodiments, the rows <NUM>, <NUM>, and <NUM> may not be offset, thereby forming a number of columns, which may, for example, be oriented parallel to the central axis <NUM>. In embodiments, the first set <NUM> of protrusions <NUM> may include any number of rows and/or columns, any number of offset rows, and/or the like. Additionally, each row and/or column of protrusions <NUM> of the first set <NUM> may include any number of protrusions <NUM> (e.g., one protrusion, two protrusions, three protrusions, four protrusions, etc.). Although all of the protrusions <NUM> of the first set <NUM> are illustrated as having the same size, shape, and orientation, in embodiments, any one or more of the size, shape, and orientation of protrusions <NUM> within a set, row, and/or column, may include any number of variances. For example, each of the protrusions <NUM> may have a truncated pyramid shape, a truncated triangular prism shape, a block shape, a cylindrical shape, and/or any other suitable three-dimensional shape.

In the illustrated embodiments, and as also shown in <FIG>, there may be a space <NUM> defined between the rows of each set of adjacent rows <NUM>, <NUM>, and <NUM>. The space <NUM> may be sized to receive corresponding teeth of a medical forceps. In embodiments, each row <NUM>, <NUM>, and <NUM> of protrusions <NUM> may have a space <NUM> between adjacent protrusions <NUM> within the same row. The size and shape of each space <NUM> may also be sized to receive corresponding teeth of a medical forceps.

As shown in <FIG>, the header <NUM> includes a second set <NUM> of protrusions <NUM> and <NUM>, arranged near the first end <NUM> of the header <NUM>. Each of the protrusions <NUM> and <NUM> of the second set <NUM> is oriented at an angle to the central axis <NUM> of the IMD <NUM>. As shown in <FIG>, the second set <NUM> of protrusions <NUM> and <NUM> includes two protrusions <NUM> and <NUM>, each oriented at an angle to the other. In a variant not claimed here, one or more of the protrusions <NUM> and <NUM> of the second set <NUM> may be parallel or perpendicular to the central axis <NUM> of the IMD <NUM>. In embodiments, the second set <NUM> of protrusions <NUM> and <NUM> may include any number of protrusions, arranged in any number of different orientations, rows and/or columns, any number of offset rows, and/or the like. Additionally, each row and/or column of protrusions <NUM> and <NUM> of the second set <NUM> may include any number of protrusions <NUM>, <NUM> (e.g., one protrusion, two protrusions, three protrusions, four protrusions, etc.). Although both of the protrusions <NUM> and <NUM> of the second set <NUM> are illustrated as having the same size, shape, and orientation, in embodiments, any one or more of the size, shape, and orientation of protrusions <NUM> and <NUM> within a set, row, and/or column, may include any number of variances. Additionally, in embodiments, one or more of the protrusions <NUM> and/or <NUM> may have a same, similar, or different size and/or shape as any one or more of the protrusions <NUM> of the first set <NUM>.

<FIG> is a side view of the IMD header <NUM> depicted in <FIG>, in accordance with embodiments of the disclosure. As shown in <FIG>, a second surface <NUM> of the header <NUM> may include a third set <NUM> of protrusions <NUM> and a fourth set <NUM> of protrusions <NUM>. As shown, the third set <NUM> of protrusions <NUM> may be arranged in two rows perpendicular to the central axis <NUM> and the fourth set <NUM> of protrusions <NUM> may include two protrusions <NUM>, each arranged at a different angle with respect to the central axis <NUM> (e.g., in a similar manner as the protrusions <NUM> and <NUM> are arranged). According to embodiments, the third and fourth sets <NUM> and <NUM>, respectively, may include any number of protrusions arranged in any number of ways.

<FIG> is an expanded perspective view of a portion of the IMD header <NUM> depicted in <FIG>, in accordance with embodiments of the disclosure, showing a close-up view of the first set <NUM> of protrusions <NUM>. As shown, each of the protrusions <NUM> may have a truncated triangular prism shape. For example, each protrusion <NUM> may have a first base <NUM>, having a width <NUM>, attached to the first surface <NUM> of the IMD <NUM>. Additionally, each of the protrusions <NUM> may have a narrower second base <NUM>, having a width <NUM> that is less than the width <NUM> of the first base <NUM>. In embodiments, the first base <NUM> and the second base <NUM> may each be at least approximately planar and, in embodiments, at least approximately parallel. A first pair of opposite sides <NUM> and <NUM> may extend between the first and second bases <NUM> and <NUM>, and may be slanted, as shown. A second pair of opposite sides <NUM> and <NUM> may also extend between the first and second bases <NUM> and <NUM>, and may be slanted, as shown. In embodiments, one or more of the sides <NUM>, <NUM>, <NUM>, and <NUM> may not be slanted (e.g., may be oriented at least approximately perpendicular to the first surface <NUM>), and/or may have a different angle of slant than one or more of the other sides <NUM>, <NUM>, <NUM>, and <NUM>.

The height <NUM> of each protrusion <NUM> may be sized to form a complementary fit to the teeth of a medical forceps (not shown). In embodiments, a length <NUM> of one or more protrusions <NUM> of the first set <NUM> may be less than, equal to, or greater than a length of one or more protrusions <NUM>, <NUM> of the second set <NUM>; the width of one or more of the bases <NUM> and <NUM> of one or more protrusions <NUM> of the first set <NUM> may be less than, equal to, or greater than a width of one or more of the bases of protrusions <NUM>, <NUM> of the second set <NUM>; and the height <NUM> of one or more protrusions <NUM> of the first set <NUM> may be less than, equal to, or greater than a height of one or more protrusions <NUM>, <NUM> of the second set <NUM>.

<FIG> is a top view of a header <NUM> of an IMD <NUM>, in accordance with embodiments of the disclosure. The IMD <NUM> may be, be identical to, or be similar to, the IMD <NUM> depicted in <FIG>, the IMD <NUM> depicted in <FIG>, the IMD <NUM> depicted in <FIG>, and/or the IMD <NUM> depicted in <FIG>. A central axis <NUM> of symmetry extends along the length of the IMD <NUM>, and extending from a first end <NUM> of the header <NUM> to a second end <NUM>, of the header <NUM>, as shown.

A first set <NUM> of protrusions <NUM> is arranged, on a first surface <NUM> (which forms a portion of an outer surface of the IMD <NUM>), near the second end <NUM> of the header <NUM>. As shown in <FIG>, the first set <NUM> of protrusions <NUM> is arranged in four rows <NUM>, <NUM>, <NUM>, and <NUM>. Each row <NUM>, <NUM>, <NUM>, and <NUM> includes one protrusion <NUM>, and is oriented perpendicular to the central axis <NUM> and extends partially (and, in embodiments, at least approximately entirely) across a width <NUM> of the header <NUM>, defined between a first side <NUM> and a second side <NUM>. In other embodiments, one or more of the rows <NUM>, <NUM>, <NUM>, and <NUM> may include more than one protrusion <NUM>. Additionally, the first set <NUM> of protrusions <NUM> may include any number of rows and/or columns, any number of offset rows, and/or the like. Although all of the protrusions <NUM> of the first set <NUM> are illustrated as having the same size, shape, and orientation, in embodiments, any one or more of the size, shape, and orientation of protrusions <NUM> within a set, row, and/or column, may include any number of variances. For example, each of the protrusions <NUM> may have a truncated pyramid shape, a truncated triangular prism shape, a block shape, a cylindrical shape, and/or any other suitable three-dimensional shape. In the illustrated embodiments, and as also shown in <FIG>, there may be a space <NUM> defined between the rows of each set of adjacent rows <NUM>, <NUM>, <NUM>, and <NUM>. The space <NUM> may be sized to receive corresponding teeth of a medical forceps.

As shown in <FIG>, the header <NUM> includes a second set <NUM> of protrusions <NUM>, arranged near the first end <NUM> of the header <NUM>. Each of the protrusions <NUM> of the second set <NUM> is oriented at an angle to the central axis <NUM> of the IMD <NUM>. As shown in <FIG>, the second set <NUM> of protrusions <NUM> includes two protrusions <NUM>, each oriented at an angle to the other. In a variant not claimed here, one or more of the protrusions <NUM> of the second set <NUM> may be parallel or perpendicular to the central axis <NUM> of the IMD <NUM>. In embodiments, the second set <NUM> of protrusions <NUM> may include any number of protrusions, arranged in any number of different orientations, rows and/or columns, any number of offset rows, and/or the like. Additionally, each row and/or column of protrusions <NUM> of the second set <NUM> may include any number of protrusions <NUM> (e.g., one protrusion, two protrusions, three protrusions, four protrusions, etc.). Although both of the protrusions <NUM> of the second set <NUM> are illustrated as having the same size, shape, and orientation, in embodiments, any one or more of the size, shape, and orientation of protrusions <NUM> within a set, row, and/or column, may include any number of variances. Additionally, in embodiments, one or more of the protrusions <NUM> may have a same, similar, or different size and/or shape as any one or more of the protrusions <NUM> of the first set <NUM>.

<FIG> is a side view of the IMD header <NUM> depicted in <FIG>, in accordance with embodiments of the disclosure. As shown in <FIG>, a second surface <NUM> of the header <NUM> may include a third set <NUM> of protrusions <NUM> and a fourth set <NUM> of protrusions <NUM>. As shown, the third set <NUM> of protrusions <NUM> may be arranged in two rows perpendicular to the central axis <NUM> and the fourth set <NUM> of protrusions <NUM> may include two protrusions <NUM>, each arranged at a different angle with respect to the central axis <NUM> (e.g., in a similar manner as the protrusions <NUM> are arranged). According to embodiments, the third and fourth sets <NUM> and <NUM>, respectively, may include any number of protrusions arranged in any number of ways.

<FIG> is an expanded perspective view of a portion of the IMD header <NUM> depicted in <FIG>, in accordance with embodiments of the disclosure, showing a close-up view of the first set <NUM> of protrusions <NUM>. As shown, each of the
protrusions <NUM> may have an elongated truncated pyramid shape. For example, each protrusion <NUM> may have a first base <NUM>, having a width <NUM>, that is attached to the first surface <NUM> of the IMD <NUM>. Additionally, each of the protrusions <NUM> may have a narrower second base <NUM>, having a width <NUM> that is less than the width <NUM> of the first base <NUM>. In embodiments, the first base <NUM> and the second base <NUM> may each be at least approximately planar and, in embodiments, at least approximately parallel. A pair of opposite sides <NUM> and <NUM> may extend between the first and second bases <NUM> and <NUM>, and may be slanted, as shown. A second pair of opposite sides <NUM> and <NUM> may also extend between the first and second bases <NUM> and <NUM>, and may be slanted, as shown. In embodiments, one or more of the sides <NUM>, <NUM>, <NUM>, and <NUM> may not be slanted (e.g., may be oriented at least approximately perpendicular to the first surface <NUM>), and/or may have a different angle of slant than one or more of the other sides <NUM>, <NUM>, <NUM>, and <NUM>.

The height <NUM> of each protrusion <NUM> may be sized to form a complementary fit to the teeth of a medical forceps (not shown). In embodiments, a length <NUM> of one or more protrusions <NUM> of the first set <NUM> may be less than, equal to, or greater than a length of one or more protrusions <NUM> of the second set <NUM>; the width of one or more of the bases <NUM> and <NUM> of one or more protrusions <NUM> of the first set <NUM> may be less than, equal to, or greater than a width of one or more of the bases of protrusions <NUM> of the second set <NUM>; and the height <NUM> of one or more protrusions <NUM> of the first set <NUM> may be less than, equal to, or greater than a height of one or more protrusions <NUM> of the second set <NUM>.

Embodiments of an IMD configured to be implanted within a patient's body (e.g., subcutaneously within an implantation location or pocket in the patient's chest or abdomen) and having protrusions coupled to an outer surface are described above. To reduce movement of the IMD, the protrusions placed on the outer surface of the IMD may be sized and arranged to allow a patient's tissue to be situated between the protrusions. In embodiments, the protrusions provide a structure that reduces at least one of rotational, translational, and lateral movement of the IMD within a patient's tissue after implantation in the patient. For example, having protrusions arranged at least partially across the width of an IMD may prevent longitudinal movement of the IMD within a patient's tissue, and having protrusions arranged at an angle to the central axis of the IMD may prevent the IMD from flipping or rotating within the patient's tissue. Additionally, having protrusions attached to the outer surface of the IMD may provide a structure that is complementary to the teeth of an insertion or extraction tool, giving a medical provider more control over the IMD while being held. For example, the protrusions may be sized and shaped to provide added frictional engagement with a medical forceps. The protrusions may make it easier for a heath care worker to grab the IMD with an extraction tool and remove the IMD from a patient without the IMD slipping from the extraction tool.

<FIG> is a flow diagram depicting an illustrative method <NUM> of manufacturing an IMD in accordance with embodiments of the disclosure. The IMD may be, for example, the IMD <NUM> depicted in <FIG>, the IMD <NUM> depicted in <FIG>, the IMD <NUM> depicted in <FIG>, the IMD <NUM> depicted in <FIG>, and/or the IMD <NUM> depicted in <FIG>. Embodiments of the method <NUM> include providing a core assembly (block <NUM>), which may include obtaining and/or assembling one or more portions of a core circuitry assembly such as, for example, by assembling an integrated circuit, coupling circuitry to a liner, and/or the like, and enclosing the core circuitry assembly within a core assembly housing.

The method <NUM> also may include providing a header (block <NUM>), which may include obtaining and/or assembling one or more portions of a header such as, for example, by arranging circuit components (e.g., an electrode and an antenna) on a scaffold assembly and enclosing the scaffold assembly within a header assembly housing. Protrusions are formed on the header assembly (block <NUM>). In embodiments, for example, the header assembly housing may be formed from an epoxy, polymer, and/or the like, and may be formed by injection molding. The protrusions may be formed by designing the injection molds to include protrusions such that the protrusions are integrated into the structure of the header assembly housing. In other embodiments, the protrusions may be attached to the header assembly housing by other means such as, for example, by adhesion, welding, and/or the like. According to embodiments, protrusions may additionally, or alternatively, be formed on any number of other components (e.g., the core assembly housing, the battery assembly housing, and/or the electrode assembly housing).

The method <NUM> may also include providing a battery assembly (block <NUM>) and providing feed-through assemblies (block <NUM>), which may include obtaining and/or assembling a battery assembly and/or a first and second feed-through assembly. The method <NUM> may also include providing an electrode assembly (block <NUM>), which may include forming an electrode that can be disposed on an outer surface of the battery assembly housing, forming an electrode that can be integrated within the battery assembly housing, forming an electrode assembly having a housing within which is disposed an electrode, and/or the like. As depicted in <FIG>, embodiments of the method <NUM> also include coupling the feed-through assemblies to the core assembly (block <NUM>), coupling the header to a first feed-through assembly (block <NUM>), coupling the battery assembly to a second feed-through assembly (block <NUM>), and coupling the electrode assembly to the battery assembly (block <NUM>).

Claim 1:
An implantable medical device (<NUM>) comprising:
a housing having an outer surface; (<NUM>);
a plurality of protrusions (<NUM>), wherein the plurality of protrusions (<NUM>) are configured to reduce at least one of rotational, translational, and lateral movement of the implantable medical device (<NUM>) within a patient's tissue after implantation in the patient;
a core assembly (<NUM>) comprising a core assembly housing (<NUM>), the core assembly (<NUM>) having a first end (<NUM>) and a second end (<NUM>); and
a header (<NUM>, <NUM>) coupled at a first header end (<NUM>) to the first end of the core assembly housing (<NUM>), the header (<NUM>) comprising a header housing (<NUM>) having an outer surface extending from the first header end (<NUM>, <NUM>) to a second header end (<NUM>, <NUM>),
wherein the plurality of protrusions (<NUM>) extends from the outer surface of the header housing (<NUM>), wherein the plurality of protrusions are shaped to provide a complementary fit to a plurality of teeth of a medical insertion or extraction tool,
wherein the outer surface of the header housing (<NUM>) includes a first side and a second, opposite-facing, side, the plurality of protrusions (<NUM>) comprising a plurality of rows of protrusions (<NUM>), each row extending at least partially across a width of the first side, wherein each of the plurality of rows of protrusions (<NUM>) includes at least two protrusions or at least one elongate protrusion,
wherein each of the plurality of rows of protrusions (<NUM>) is oriented parallel to a first axis (<NUM>), wherein the first axis is perpendicular to a second axis (<NUM>), the second axis (<NUM>) comprising an axis of symmetry of the header (<NUM>), extending from the first header end (<NUM>, <NUM>) to the second header end (<NUM>, <NUM>), characterized in that
the header (<NUM>, <NUM>) further comprising a second set (<NUM>) of protrusions, arranged near the first header end (<NUM>), the second set (<NUM>) of protrusions including two elongated protrusions (<NUM>, <NUM>), each oriented at an angle to the other, the two elongated protrusions (<NUM>, <NUM>) each being oriented at an angle to the second axis (<NUM>), which angle is not parallel or perpendicular to the second axis (<NUM>).