Patent Description:
Implantable medical devices are now commonly used for monitoring a patient's condition and in some cases also administering therapy to the patient. In some cases, the implantable medical device may be implanted only temporarily. In other cases, the implantable medical device may be implanted chronically over a period of years.

In general, it can be desirable to minimize the size of a device to be implanted in the body. Reduced size can boost patient comfort as well as allow for greater placement site and placement method flexibility. As a result, there is a general trend towards smaller and smaller devices over time. For example, state-of-the-art pacemakers are typically much smaller today than the pioneering devices of decades past. Reduced size has been made possible through advancements in the materials and component parts of devices as well as refinements of overall designs.

Metal structures can have residual stresses. Residual stresses are locked-in stresses within a metal object, even though the object is free of external forces. Residual stresses can be tensile or compressive. Residual stresses can reduce the longevity of structures they are included within.

<CIT> discloses a method for pulse generation in an implantable device, comprising measuring an impedance between a first electrode and a second electrode and delivering a pulse based on a pulse energy level and a pulse duration limit, comprising generating a pulse duration as a function of the pulse energy level and the impedance and selecting a capacitance value from a plurality of capacitances in a partitioned capacitor bank to deliver a pulse at the pulse energy level and wherein the pulse duration is less than the pulse duration limit.

Embodiments herein relate to implantable medical devices including a welded joint with reduced residual stress. According to the invention, an implantable medical device is included having a power subunit comprising a first biocompatible electrically conductive shell defining an open end, a closed end, and an interior volume, an anode disposed within the interior volume of the first biocompatible electrically conductive shell, a cathode disposed within the interior volume of the first biocompatible electrically conductive shell, and a lid occluding the open end of the first biocompatible electrically conductive shell. The implantable medical device can further include an electronics control subunit comprising a second biocompatible electrically conductive shell, and a control circuit disposed within the second biocompatible electrically conductive shell. The power subunit can be coupled to the electronics control subunit and the power subunit can be in electrical communication with the electronics control subunit. Both of the first and second biocompatible electrically conductive shells can include first and second opposed wide sides, first and second opposed narrow sides, wherein the narrow sides have a width less than that of the wide sides, and four rounded comers disposed at intersections between each wide side and narrow side. The first biocompatible electrically conductive shell can be welded to the lid around a perimeter of the first biocompatible electrically conductive shell forming a weld line. The weld line can have a weld line terminus, wherein the weld line terminus is positioned on a narrow side or a rounded comer.

In a second aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the weld line can include a laser weld line.

In a third aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first biocompatible electrically conductive shell and the second biocompatible electrically conductive shell can include titanium or a titanium alloy.

In a fourth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the weld line can be positioned on a rounded corner.

In a fifth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, wherein the weld line exhibits a residual stress that is less than an otherwise identical weld line with the weld line terminus positioned on a wide side.

In a sixth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, wherein the second biocompatible electrically conductive shell can be welded to the lid around the perimeter of the second biocompatible electrically conductive shell forming a second weld line.

In a seventh aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the second weld line having a second weld line terminus, wherein the second weld line terminus can be positioned on a narrow side or a rounded corner.

In an eighth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first and second biocompatible electrically conductive shells can have a thickness of <NUM> to <NUM> inches (<NUM> inch = <NUM>,<NUM>).

In a ninth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first and second opposed wide sides can be first and second opposed wide flat sides, and the first and second opposed narrow sides can be first and second opposed narrow flat sides.

In a tenth aspect, a method of making an implantable medical device is included. The method can include obtaining a biocompatible electrically conductive shell, the biocompatible electrically conductive shell defining an interior volume, and an open end and a closed end. The method can further include positioning a lid to occlude the open end of the biocompatible electrically conductive shell. The method can further include welding the biocompatible electrically conductive shell to the lid along a weld line, the weld line comprising a terminus. The biocompatible electrically conductive shell can include first and second opposed wide flat sides and first and second opposed narrow flat sides. The narrow flat sides can have a width less than that of the wide flat sides. Four rounded comers can be disposed between each wide flat side and an adjacent narrow flat side. The terminus of the weld line can be disposed on a narrow flat side or a rounded comer.

In an eleventh aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, a method can further include welding a second biocompatible electrically conductive shell to the lid along a second weld line, the second weld line including a terminus, the second biocompatible electrically conductive shell including first and second opposed wide flat sides, first and second opposed narrow flat sides. The narrow flat sides can have a width less than that of the wide flat sides and four rounded corners can be disposed between each wide flat side and an adjacent narrow flat side. The terminus of the second weld line can be disposed on a narrow flat side or a rounded corner.

In a twelfth aspect, the lid can include a central body and an extended rim surrounding the central body. The first biocompatible electrically conductive shell can be welded to the extended rim of the lid.

In a thirteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the extended perimeter rim can be separated from the central body by a relief channel.

In a fourteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the extended perimeter rim and the first biocompatible electrically conductive shell can form a butt joint.

In a fifteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the extended perimeter rim and the first biocompatible electrically conductive shell can form an overlap joint.

In a sixteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the extended perimeter rim can overlap the first biocompatible electrically conductive shell.

In a seventeenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the lid further including a second extended rim surrounding the central body, wherein the second extended rim faces in a direction opposite that of the first extended rim.

In an eighteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, wherein the first biocompatible electrically conductive shell includes, in cross-section, first and second opposed wide flat sides, and first and second opposed narrow flat sides. The narrow flat sides can have a width less than that of the wide flat sides. Four rounded comers can be disposed between each wide flat side and an adjacent narrow flat side. The first biocompatible electrically conductive shell can be welded to the lid around a perimeter thereof forming a weld line. The weld line can have a weld line terminus, wherein the weld line terminus is positioned on a narrow flat side or a rounded corner.

In a nineteenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the weld line can be a laser weld line.

In a twentieth aspect, in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, the first biocompatible electrically conductive shell can include titanium or a titanium alloy.

This summary is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the present subject matter. Further details are found in the detailed description and appended claims. Other aspects will be apparent to persons skilled in the art upon reading and understanding the following detailed description and viewing the drawings that form a part thereof, each of which is not to be taken in a limiting sense.

While embodiments are susceptible to various modifications and alternative forms, specifics thereof have been shown by way of example and drawings, and will be described in detail.

As referenced above, metal structures can have residual stresses. Residual stresses can reduce the longevity of structures they are included within. Welding operations, because of rapid thermal expansion and contraction created along a very localized area, can be a significant source of residual stress. Typically, a very high heat source is applied to a small area relative to the cooler surrounding area. The metal expands as it is brought to a molten state. As the molten weld pool solidifies along the joint, there is resistance to its shrinkage by the already solidified weld metal and the unmelted base metal adjacent to the weld. This resistance can create a tensile strain in the longitudinal and transverse directions of the weld.

Various types of implantable medical devices may include portions that are welded together, therefore creating residual stress in and around those welded portions. For example, implantable medical devices including a power subunit and an electronics control subunit may be welded together to form a unitary structure that is later implanted. The welding process creating the weld j oint(s) or weld line(s) may result in significant residual stresses.

In accordance with embodiments herein, the weld joints or weld lines can be formed to minimize residual stresses. For example, it has been identified herein that the position of the end of a weld line can significantly impact the magnitude of residual stress in the area along and adjacent to the weld line. In accordance with various embodiments herein, the end of a weld line can be positioned on or around the corner of a device shell or case. In accordance with various embodiments herein, the end of a weld line can be positioned to be disposed on or around short sides of a device shell or case that is roughly rectangular in cross-section.

In accordance with embodiments herein, the structure of components that are joined with weld joints or weld lines can be manipulated to reduce minimize residual stresses. For example, the structure of a lid or interconnecting structure that is welded to a device shell or case can be formed to reduce or minimize residual stresses.

Referring now to <FIG>, a schematic view is shown of an implantable medical device <NUM> implanted within a patient <NUM> in accordance with various embodiments herein. In various embodiments, at least a portion of the medical device system can be implantable. In some embodiments, the implantable medical device <NUM> can include an implantable loop recorder, implantable monitor device, or the like. In some embodiments, the entire implantable medical device <NUM> can be implanted within the body of a patient <NUM>. Various implant sites can be used including areas on the limbs, the upper torso, the abdominal area, and the like. In some embodiments, the implantable medical device <NUM> can be implanted subcutaneously. In some embodiments, the medical device system can include one or more additional medical devices that are communicatively coupled to one another.

Referring now to <FIG>, a schematic view of an implantable medical device <NUM> is shown in accordance with various embodiments herein. The implantable medical device <NUM> can include a power subunit <NUM>, an electronics control subunit <NUM>, and a wireless communications subunit <NUM>. The power subunit <NUM> can include components of an electrochemical cell. The power subunit <NUM> can include a first biocompatible electrically conductive shell <NUM> configured for direct contact with an in vivo environment. The electronics control subunit <NUM> can include electronic components to control operations of the device including, for example, a controller or control circuit. The electronics control subunit <NUM> can include a second biocompatible electrically conductive shell <NUM> configured for direct contact with an in vivo environment.

The power subunit <NUM> can be coupled to the electronics control subunit <NUM>. In some embodiments, the power subunit <NUM> can be welded to the electronics control subunit <NUM>. Welding can be performed using various techniques including laser welding. In various embodiments, the first biocompatible electrically conductive shell of the power subunit has about the same cross-sectional perimeter dimensions as the second biocompatible electrically conductive shell of the electronics control subunit. In various embodiments, the first biocompatible electrically conductive shell of the power subunit has cross-sectional perimeter dimensions that are less than <NUM>% different than that of the second biocompatible electrically conductive shell of the electronics control subunit.

The implantable medical device <NUM> can have various dimensions. The overall length (X axis) can be greater than or equal to <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In some embodiments, the length can be less than or equal to <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In some embodiments, the length can fall within a range of <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or can be about <NUM>.

The overall width (Y axis) can be greater than or equal to <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In some embodiments, the width can be less than or equal to <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In some embodiments, the width can fall within a range of <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or can be about <NUM>.

The overall depth (Z axis) can be greater than or equal to <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In some embodiments, the depth can be less than or equal to <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>. In some embodiments, the depth can fall within a range of <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or <NUM> to <NUM>, or can be about <NUM>.

Referring now to <FIG>, a schematic view of an implantable medical device <NUM> is shown in accordance with various embodiments herein. In this view, the electrically conductive shell <NUM> has been removed to show the components within the electronics control subunit <NUM> of the implantable medical device. The electronics control subunit <NUM> can include a circuit board <NUM> and power input connections <NUM>, <NUM> which can be in electrical communication with output pins of the power subunit <NUM>. The electronics control subunit <NUM> can further include a controller <NUM> which can form part of a control circuit. The electronics control subunit <NUM> can further circuit components <NUM> and <NUM>. It will be appreciated that many different circuit components can be included such as integrated circuits of various types, signal processing chips, ASICs (application specific integrated circuits), clock circuits, capacitors, and the like. The electronics control subunit <NUM> can also include I/O pins <NUM>. The total number of I/O pins (digital or analog) is not particularly limited. The wireless communications subunit <NUM> can include an antenna <NUM>, which can be in electrical communication with I/O pins <NUM>. In some embodiments, one of the I/O pins <NUM> can be a negative bias output pin, which can be regulated to provide a relative negative electrical potential.

Referring now to <FIG>, a power subunit <NUM> is shown in accordance with various embodiments herein. The power subunit <NUM> can include electrically conductive shell <NUM>. The electrically conductive shell can include a closed end and an open end and can define an interior volume therein. The power subunit <NUM> can further include a lid <NUM>, which can be attached (such as by welding or another technique) to the electrically conductive shell <NUM> and can occlude the open end of the electrically conductive shell. The power subunit <NUM> can further include an anode pin <NUM> and a cathode pin <NUM>. Anode pin <NUM> and cathode pin <NUM> can be formed of various conductive materials such as metals. In some embodiments, the anode pin <NUM> and/or the cathode pin <NUM> are formed of molybdenum or a molybdenum containing alloy. However, many different pin materials are contemplated herein.

In various embodiments, the implantable medical device can be configured so that the biocompatible electrically conductive shell <NUM> of the power subunit <NUM> and/or electrically conductive shell of the electronics control subunit <NUM> has a relative positive, negative, or neutral electrical potential.

Referring now to <FIG>, a cross-sectional view of the power subunit <NUM> is shown as taken along line <NUM>-<NUM>' of <FIG> in accordance with various embodiments herein. The power subunit <NUM> can include components of an electrochemical cell <NUM> including a cathode <NUM> and an anode <NUM>. Referring now to <FIG>, an enlarged view of a portion of <FIG> is shown in accordance with various embodiments herein. In this view, it can be seen that the power subunit <NUM> can include an anode pin <NUM> and a lid <NUM>. Further, an anode connection tab <NUM> can provide electrical communication between the anode <NUM> and the lid <NUM> and the shell <NUM> or case of the power subunit <NUM>, thus provide the shell <NUM> or case with a relative negative electrical potential.

Referring now to <FIG>, a cross-sectional view of the power subunit <NUM> is shown as taken along line <NUM>-<NUM>' of <FIG> in accordance with various embodiments herein. Again, the power subunit <NUM> can include components of an electrochemical cell <NUM> including a cathode <NUM> and an anode <NUM>. Referring now to <FIG>, an enlarged view of a portion of <FIG> is shown in accordance with various embodiments herein. In this view, it can be seen that the power subunit <NUM> can include a cathode pin <NUM> and a lid <NUM>. Further, cathode connection tabs <NUM> can provide electrical communication between the cathode <NUM> and the cathode pin <NUM>. A feedthrough structure <NUM> can serve to electrically isolate the cathode pin <NUM> from the shell <NUM> and case of the power subunit <NUM>. The feedthrough structure <NUM> can be formed of a non-conductive material such as a non-conductive ceramic, glass, polymer, composite, or the like.

It will be appreciated that while the embodiment shown in <FIG> provides for a relatively negative electrical potential for the biocompatible electrically conductive shell <NUM> of the power subunit <NUM>, that other configurations are contemplated herein. In specific, configurations with neutral or relatively positive electrical potentials are contemplated herein.

It has been found that residual stress can be reduced by careful placement of the end of a weld line. For example, it has been found that residual stress can be reduced by placing the end (or terminus) of a weld line in a corner or along a narrow side (such as a narrow flat side) of the shell or housing. Thus, when the weld line terminus is placed in a corner or along a narrow side, the weld line exhibits a residual stress that is less than an otherwise identical weld line with a weld line terminus positioned on a wide side (or wide flat side).

Referring now to <FIG>, a cross-sectional view of a shell <NUM> or case as taken along line <NUM>-<NUM>' of <FIG> is shown in accordance with various embodiments herein. The shell <NUM> defines an interior volume <NUM> including which various components can be placed, such as in the context of a power subunit components of an electrochemical cell. The outside <NUM> of the shell <NUM> can be an in vivo environment after the device is implanted within a subject.

The shell can include first and second opposed wide sides <NUM>, <NUM> (such as wide flat sides), first and second opposed narrow sides, <NUM>, <NUM> (such as narrow flat sides), wherein the narrow sides have a width less than that of the wide sides. The wide sides can have a width that is <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> percent or more (or an amount falling within a range between any of the foregoing) greater than that of the narrow sides. The shell <NUM> can also include four rounded corners <NUM>, <NUM>, <NUM>, and <NUM> disposed between each wide side and adjacent narrow side. The four rounded corners can be disposed at intersections between each wide side and narrow side. In some embodiments, the wide sides can be substantially flat. However, in other embodiments, the wide sides can include a degree of curvature. In some embodiments, the narrow sides can be substantially flat. However, in other embodiments, the narrow sides can include a degree of curvature.

In some embodiments, the thickness of the shell <NUM> can be greater than or equal to <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, or <NUM> inches. In some embodiments, the thickness of the shell <NUM> can be less than or equal to <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, <NUM> inches, or <NUM> inches. In some embodiments, the thickness of the shell <NUM> can fall within a range of <NUM> inches to <NUM> inches, <NUM> inches to <NUM> inches, or <NUM> inches to <NUM> inches, or <NUM> inches to <NUM> inches, or <NUM> inches to <NUM> inches, or can be about <NUM> inches on average (mean).

In some embodiments, the shell <NUM> can be deep drawn. However, deep drawing can result in a structure with higher residual stress and a greater number of surface cracks which can serve as concentration points for stress. In some embodiments, the shell <NUM> can be machined (e.g., can have machined surfaces). Machining the structure can result in reduced residual stress and fewer surface cracks. In some embodiment, the surface roughness (inside surface and/or outside surface) can be less than or equal to <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>µin Ra, or can be an amount falling within a range between any of the foregoing. Other techniques for forming the shell <NUM> can include stamping processes, additive manufacturing processes, and the like.

The shell <NUM> can be formed of various materials. In some embodiments, the shell <NUM> can include a metal. In some embodiments, the shell <NUM> can include one or more of titanium, titanium alloys, stainless steel, cobalt-chromium alloys, and the like.

Referring now to <FIG>, a schematic view is shown of a weld line on an implantable medical device in accordance with various embodiments herein. The implantable medical device can include a power subunit <NUM> and an electronics control subunit <NUM>. A lid <NUM> or interconnecting structure is shown between the power subunit <NUM> and an electronics control subunit <NUM>. An exemplary weld line <NUM> or joint can include a weld line terminus <NUM> or end. The weld line <NUM> shown can represent a weld line between the shell or case of the power subunit <NUM> and the lid <NUM>, or a weld line between the shell or case of the electronics control subunit <NUM> and the lid <NUM>, or a weld line directly between the shell or case of the power subunit <NUM> and the shell or case of the electronics control subunit <NUM>, or more than one of these (it being appreciated that the implantable medical device can include more than one weld line).

The weld line terminus <NUM> or terminus can be characterized by a circular perimeter, typically forming an unbroken circle, that results in the last area where the energy is applied to cause welding (such as the last place where laser energy is applied). In some cases, there is a slight depression <NUM> in the center of the weld line terminus <NUM> relative to a slightly raised ring <NUM> forming the perimeter of the weld line terminus <NUM>. In some embodiments, the difference in height between the depression <NUM> and the surrounding ring <NUM> can be greater than or equal to <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch. In some embodiments, the difference in height can be less than or equal to <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> thousandths of an inch. In some embodiments, the difference in height can fall within a range of <NUM> to <NUM> thousandths, or <NUM> to <NUM> thousandths, or <NUM> to <NUM> thousandths, or <NUM> to <NUM> thousandths, or <NUM> to <NUM> thousandths of an inch. Aspects of welding are described in greater detail below.

In accordance with embodiments herein, the structure of components that are joined with weld joints or weld lines can be manipulated to reduce minimize residual stresses. For example, the structure of a lid or interconnecting structure that is welded to a device shell or case can be formed to reduce or minimize residual stresses. Referring now to <FIG>, a partial cross-sectional view is shown of a joint between a shell <NUM> or case and a lid <NUM> in accordance with various embodiments herein. The lid <NUM> comprises a central body <NUM> and an extended rim <NUM> surrounding the central body <NUM>. The extended rim <NUM> can be a perimeter rim. The shell <NUM> or case can be welded to the extended rim <NUM> of the lid <NUM>. The extended rim <NUM> can be separated from the central body <NUM> by a relief channel <NUM>. The relief channel <NUM> can provide a mechanical separation between the end <NUM> of the extended rim <NUM> and the central body <NUM>. The lid <NUM> can also include a ledge <NUM> or bevel to interface with and form a joint with another shell or case, such as the shell or case of an electronics control subunit <NUM>.

In some embodiments, the relief channel <NUM> can have a width of about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>, or an amount falling within a range between any of the foregoing. The length <NUM> of the extended rim <NUM> with respect to the depth of the relief channel <NUM> can be about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more, or can be an amount falling within a range between any of the foregoing. The thickness of the extended rim <NUM> can be roughly equivalent to the thickness of the shell <NUM>. However, in some embodiments the extended rim <NUM> can be thicker or thinner than the shell <NUM>.

Many different variations for the joint between the shell or case and the lid are contemplated herein. Referring now to <FIG>, a partial cross-sectional view is shown of a joint between a shell <NUM> or case and a lid <NUM> in accordance with various embodiments herein. The embodiment of <FIG> is similar to that of <FIG>. However, in this embodiment, the interface between the shell <NUM> and the extended rim <NUM> is formed by opposed tongues <NUM>, <NUM> creating a lap joint.

However, it will be appreciated that in some embodiments, a relief channel <NUM> can be substantially reduced in size or even omitted. Referring now to <FIG>, a partial cross-sectional view is shown of a joint between a shell <NUM> or case and a lid <NUM> in accordance with various embodiments herein. In this embodiment, the interface between the shell <NUM> and the lid <NUM> is formed by opposed tongues <NUM>, <NUM> creating a lap joint.

In some embodiments, an extended perimeter rim may be formed even in the absence of a relief channel. Further, in some embodiments, an extended perimeter rim can overlap the shell or case (to the inside or to the outside). Referring now to <FIG>, a partial cross-sectional view is shown of a joint between a shell <NUM> or case and a lid <NUM> in accordance with various embodiments herein. In this embodiment, there is a neck region <NUM> between the extended rim <NUM> and the shell <NUM>. The neck region <NUM> can vary in size. In some embodiments the overlapping region can be about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or more, or can be an amount falling within a range between any of the foregoing. In some embodiments the overlapping region can be a full-thickness overlap between the extended rim <NUM> and the shell <NUM>. In other embodiments, the overlapping region can be a partial-thickness overlap.

In the context of an embodiment with an overlapping region between the extended rim <NUM> and the shell <NUM>, in some cases the shell <NUM> can fit within the rim <NUM> and therefore have a smaller outside perimeter than the rim <NUM>. In other cases, the shell <NUM> can fit over the rim <NUM> and therefore have a larger outside perimeter than the rim <NUM>. In still other cases, the shell <NUM> can be necked inward at the top thereof such that a portion of the shell <NUM> can fit within the outside perimeter of the rim <NUM>, but the remainder of the shell <NUM> can have an outside perimeter that is similar to or the same as the lid <NUM> and/or a rim <NUM> thereof.

Referring now to <FIG>, a partial cross-sectional view is shown of a joint between a shell <NUM> or case and a lid <NUM> in accordance with various embodiments herein. In this embodiment, a neck region <NUM> can be formed at the top of the shell <NUM> through an inward curvature <NUM> of the shell <NUM> in an area near where the shell <NUM> interfaces with a lid <NUM> and/or a rim <NUM> thereof. In some embodiments, the neck region <NUM> can be necked inward by a distance approximately equivalent to the thickness of the shell <NUM> and/or the thickness of a rim <NUM>.

In some embodiments, a lid can be constructed such that a relief channel is formed only on one side. For example, a lid can be constructed so that only the interface with a shell of one component (e.g., power subunit or electronics control subunit) can be separated from the main body of the lid by a relief channel. In this regard, the lid can have an asymmetrical construction from top to bottom (with respect to the orientation shown in <FIG>). However, in other embodiments, a relief channel can be formed on both sides such that both the interface between a shell of power subunit and the shell of an electronics control subunit can both be separated from the main body of the lid by relief channels.

Referring now to <FIG>, a partial cross-sectional view is shown of a joint between a shell <NUM> or case and a lid <NUM> in accordance with various embodiments herein. In this embodiment, the lid <NUM> comprises a central body <NUM> and a first extended rim <NUM> surrounding the central body <NUM>. The lid <NUM> also include a second extended rim <NUM> surrounding the central body <NUM> that is facing in a direction opposite of the first extended rim <NUM>. The first shell <NUM> or case can be welded to the first extended rim <NUM> and a second shell <NUM> or case can be welded to the second extended rim <NUM>. The first extended rim <NUM> can be separated from the central body <NUM> by a first relief channel <NUM> and the second extended rim <NUM> can be separated from the central body <NUM> by a second relief channel <NUM>. The first relief channel <NUM> can provide a mechanical separation between the end of the first extended rim <NUM> and the central body <NUM>. The second relief channel <NUM> can provide a mechanical separation between the end of the second extended rim <NUM> and the central body <NUM>. In some embodiments, the first relief channel <NUM> and the second relief channel <NUM> can be substantially identical in terms of size and shape, but in other embodiments they can be different. Similarly, in some embodiments the first extended rim <NUM> and the second extended rim <NUM> can be substantially identical in terms of size and shape, but in other embodiments they can be different.

It will be appreciated that the implantable medical device can include many different components depending on the desired functionality. Referring now to <FIG> a block diagram is shown of components of an implanted medical device in accordance with various embodiments herein. However, it will be appreciated that various specific embodiments can include a greater number of components, a lesser number of components, or different components. In this example, the implantable medical device <NUM> can include circuitry <NUM>. The circuitry <NUM> can include various electrical components, including, but not limited to a controller <NUM> (which can form part of a control circuit), a sensor <NUM> (e.g., an accelerometer, a gyroscope, a microphone, a bio-impedance sensor), a microprocessor <NUM>, therapy unit circuitry <NUM>, recorder circuitry <NUM>, and sensor interface circuitry <NUM>. Other examples of components suitable for use in the medical device systems embodied herein can include telemetry circuitry, memory circuitry (e.g., such as random access memory (RAM) and/or read only memory (ROM)), power supply circuitry (which can include, but not be limited to, one or more batteries, a capacitor, a power interface circuit, etc.), normalization circuitry, control circuitry, electrical field sensor and stimulation circuitry, display circuitry, and the like.

In some embodiments, one or more components can be integrated into the implantable medical device and in other embodiments one or more components can be separate. In some embodiments recorder circuitry can record the data produced by the sensors of the device and record time stamps regarding the same. In some embodiments, the circuitry can be hardwired to execute various functions while in other embodiments, the circuitry can be implemented as instructions executing on a controller, a microprocessor, other computation device, application specific integrated circuit (ASIC), or the like.

In some embodiments, the implantable medical device <NUM> can include a chemical sensor. In some embodiments, the chemical sensor is an optical chemical sensor. However, in other embodiments the chemical sensor can be a potentiometric chemical sensor. The chemical sensor can specifically include at least one chemical sensing element, an optical window, and an electro-optical module. The electro-optical module can be in electrical communication with the circuitry within the interior volume <NUM>. In some embodiments, the chemical sensor can be configured to measure a cellular interstitial component, a blood component, or a breath component, or any analytes thereof. In some embodiments the blood component can include blood constituents or analytes thereof, such as red blood cells; white blood cells including at least neutrophils, eosinophils, and basophils; platelets; hemoglobin; and the like.

The implantable medical device <NUM> can include a controller <NUM>. In some embodiments, the controller <NUM> can be configured to execute one or more operations described herein. The implantable medical device <NUM> can include additional components, for example, a therapy unit circuitry <NUM>. The therapy unit circuitry <NUM> can be configured to deliver a therapy to a patient and/or control or influence the delivery of a therapy provided by another device. In some embodiments, the therapy unit can be configured to provide optimum therapy to a patient depending on if they are in a recumbent, standing or sitting position. Examples of therapies can include, but are not limited to, pacing schemes such as rate-adaptive pacing, cardiac-resynchronization therapy (CRT), delivery of a neurostimulation therapy, administration of therapeutic agents, and the like. In some embodiments, the therapy unit circuitry <NUM> can be a pharmaceutical therapy unit. In some embodiments, the therapy unit circuitry <NUM> can include both an electrical therapy unit and a pharmaceutical therapy unit. In some embodiments, the therapy unit circuitry <NUM> can be directed by the controller <NUM> to deliver a therapy to a patient.

Referring now to <FIG> is a schematic diagram of components of an implantable medical device in accordance with various embodiments herein. Elements of some embodiments of a medical device system are shown in <FIG> in accordance with the embodiments herein. However, it will be appreciated that some embodiments can include additional elements beyond those shown in <FIG>. In addition, some embodiments may lack some elements shown in <FIG>. The medical device, as embodied herein, can gather information through one or more sensing channels <NUM>, <NUM>, <NUM>. A controller <NUM> can communicate with a memory <NUM> via a bidirectional data bus. The memory <NUM> can include read only memory (ROM) or random access memory (RAM) for program storage and RAM for data storage.

In some embodiments, a medical device can include one or more electric field sensors <NUM> (i.e., electrodes) and an electric field sensor channel interface <NUM> that can communicate with a port of controller <NUM>. The medical device can also include another type of sensor <NUM> and a sensor channel interface <NUM> for the same that can communicate with a port of controller <NUM>. The medical device can also include one or more chemical sensors <NUM> and a chemical sensor channel interface <NUM> that can communicate with a port of controller <NUM>. The channel interfaces <NUM>, <NUM> and <NUM> can include various components such as analog-to-digital converters for digitizing signal inputs, sensing amplifiers, registers that can be written to by the control circuitry to adjust the gain and threshold values for the sensing amplifiers, and the like. A telemetry interface <NUM> is also provided for communicating with external devices such as a programmer, a home-based unit, and/or a mobile unit (e.g. a cellular phone, laptop computer, etc.).

In some embodiments, the medical device can also include additional sensors, such as posture sensors, activity sensors, or respiration sensors integral to the medical device. In some embodiments, the medical device can also include additional sensors that are separate from medical device. In various embodiments one or more of the posture sensors, activity sensors, or respiration sensors can be within another implanted medical device communicatively coupled to the medical device via telemetry interface <NUM>. In various embodiments one or more of the additional posture sensors, activity sensors, or respiration sensors can be external to the body and are coupled to medical device via telemetry interface <NUM>.

Various welding techniques can be used. However, in many embodiments, the weld line can be formed using a laser welding technique (or laser beam welding). The laser system can be a solid-state laser system or a gas laser system. Exemplary laser systems can include, but are not limited to, ruby lasers and Nd:YAG lasers, though other laser systems are also contemplated herein. The spot size of the laser can vary. In some embodiments, the spot size can be about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM>, or can fall within a range between any of the foregoing. The power density can be about <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> MW/cm<NUM>, or an amount falling within a range between any of the foregoing. The depth of penetration can be proportional to the amount of power supplied, but also dependent on the location of the focal point. Continuous or pulsed laser beam approaches can be used. In various embodiments herein, a pulsed laser beam approach can be used. In various embodiments, the pulses can be from one to several milliseconds. In various embodiments herein, the weld line is not full thickness with respect to the materials being welded together, such as in scenarios where the weld is being applied to a butt joint. However, in other embodiments, the weld could be full thickness. In various embodiments, the weld line can penetrate <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> percent of the thickness of the materials being welded together, or an amount falling within a range between any of the foregoing.

In various embodiments herein, the electrochemical cell can be a primary lithium-manganese dioxide (Li anode/MnO<NUM> cathode) battery. However, other primary lithium battery chemistries are also contemplated herein. Other primary battery chemistries can include, but are not limited to, CFx, SVO, hybrid CFx/Mn02, hybrid CFx/SVO, and the like.

In various embodiments, the lithium battery can be constructed from a number of thin sheets of different materials that are sandwiched together to form a battery assembly. A repeating arrangement within the cell can include an anode assembly, a separator, and a cathode. The anode assembly can be formed from a sheet of lithium material that constitutes an anode and a material that constitutes a current collector. A sheet of lithium material can be laminated to a substrate, such as a current collector. The current collector can be constructed from a number of different materials. For example, the current collector can be constructed from, among other alternatives, nickel or nickel-based material, stainless steel, aluminum, titanium, or copper, or any other suitable material. The current collector can include a uniform sheet, a wire grid, or other configurations. Further details of exemplary electrochemical cell components are described in <CIT> and <CIT>.

Various electrolyte compositions can be used with electrochemical cells or batteries herein. In some embodiments, the electrolyte can be non-aqueous (e.g., organic only electrolyte solvent). In some embodiments, the electrolyte is a <NUM> LiTFSi solution in ethylene carbonate, propylene carbonate and dimethoxy ethane. Various separators can be used with electrochemical cells or batteries herein.

Embodiments herein also include various methods. By way of example, embodiments of making implantable medical devices as described herein are included. Further, embodiments of using implantable medical devices as described herein are included.

In an embodiment, a method of making an implantable medical device is included. The method can include obtaining a biocompatible electrically conductive shell, the biocompatible electrically conductive shell defining an interior volume, an open end and a closed end. The method can further include positioning a lid to occlude the open end of the biocompatible electrically conductive shell. The method can further include welding the biocompatible electrically conductive shell to the lid along a weld line, the weld line comprising a terminus. The biocompatible electrically conductive shell can include first and second opposed wide sides (or wide flat sides) and first and second opposed narrow sides (or narrow flat sides). The narrow flat sides can have a width less than that of the wide flat sides. Four rounded corners can be disposed between each wide flat side and an adjacent narrow flat side. The terminus of the weld line can be disposed on a narrow flat side or a rounded corner.

In various embodiments, the method can further include welding a second biocompatible electrically conductive shell to the lid along a second weld line, the second weld line comprising a terminus. The second biocompatible electrically conductive shell can include first and second opposed wide flat sides and first and second opposed narrow flat sides. The narrow flat sides can have a width that is less than that of the wide flat sides. The second biocompatible electrically conductive shell can further include four rounded corners disposed between each wide flat side and an adjacent narrow flat side. The terminus of the second weld line can be disposed on a narrow flat side or a rounded corner.

Other methods and method operations are also included herein as consistent with making and using embodiments of implantable medical devices as described.

All publications and patent applications in this specification are indicative of the level of ordinary skill in the art to which this invention pertains.

As used herein, the recitation of numerical ranges by endpoints shall include all numbers subsumed within that range (e.g., <NUM> to <NUM> includes <NUM>, <NUM>, <NUM>, <NUM>, etc.).

Claim 1:
An implantable medical device (<NUM>) comprising:
a power subunit (<NUM>) comprising
a first biocompatible electrically conductive shell (<NUM>) defining an open end, a closed end, and an interior volume;
an anode (<NUM>) disposed within the interior volume of the first biocompatible electrically
conductive shell (<NUM>);
a cathode (<NUM>) disposed within the interior volume of the first biocompatible electrically conductive shell; and
a lid (<NUM>) occluding the open end of the first biocompatible electrically conductive shell; and
an electronics control subunit (<NUM>) comprising
a second biocompatible electrically conductive shell (<NUM>);
a control circuit disposed within the second biocompatible electrically conductive shell (<NUM>); wherein the power subunit (<NUM>) is coupled to the electronics control subunit (<NUM>) and the power subunit is in electrical communication with the electronics control subunit; wherein both of the first and second biocompatible electrically conductive shells comprise first and second opposed wide sides (<NUM>, <NUM>);
first and second opposed narrow sides (<NUM>, <NUM>),
wherein the narrow sides have a width less than that of the wide sides; and
four rounded corners disposed at intersections between each wide side and narrow side;
wherein the first biocompatible electrically conductive shell (<NUM>) is welded to the lid (<NUM>) around a perimeter of the first biocompatible electrically conductive shell forming a weld line (<NUM>);
the weld line having a weld line terminus (<NUM>), wherein the weld line terminus is positioned on a narrow side or a rounded corner.