drilling stack tolerance

Abstract

A system and method are disclosed for absorbing a portion of a positive or negative manufacturing tolerance of at least one component of a stacked drilling assembly, the stacked drilling assembly including a first component having a distal mechanical feature and a second component having a proximal mechanical feature, the proximal mechanical feature of the second component being configured to engage the distal mechanical feature of the first component with a shoulder located on either the distal mechanical feature of the first component or the proximal mechanical feature of the second component. The shoulder may be positioned at a distance from the end of either the distal mechanical feature of the first component or the proximal mechanical feature of the second component, the distance being either shorter or longer than the length of the other.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 446,929, filed February 20, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This document generally relates to medical devices, and more specifically to systems and methods for ensuring tolerances in stacked drilled assemblies. Background Technology

[0004] Medical devices may be implanted or implantable in a patient's body, for example, to monitor the patient, including detecting or sensing physiological information from the patient, such as heart sounds, respiration (e.g., respiratory rate (RR), tidal volume (TV), etc.), impedance (e.g., chest impedance, cardiac impedance, skin impedance, etc.), pressure (e.g., blood pressure), cardiac activity (e.g., heart rate, electrocardiogram information, etc.), chemicals (e.g., electrolytes), body activity, posture, plethysmography, or one or more other physiological information of the patient, and, in some examples, to provide treatment to the patient in clinical and mobile settings. Implantable medical devices (IMDs) may include cardiac rhythm management (CRM) devices, such as pacemakers, cardiac resynchronization devices, cardioverter-defibrillators, defibrillators, drug delivery devices, or one or more other medical devices implanted or implantable in or under the skin of a patient.

[0005] Implantable medical devices typically include: an hermetically sealed housing housing the device's electronic circuitry (e.g., one or more signal processing or control circuits, telemetry circuits, therapeutic circuits, power management circuits, etc.) and a power source; and one or more drill assemblies (or lead ports, or lead connector cavities, etc.) located in a head portion outside the hermetically sealed housing to receive and connect one or more leads having one or more electrodes or other sensors located at or near the patient's heart, such as in one or more of the atria or ventricles. Separate from or in addition to the leads, or other electrodes or sensors, the implantable medical device may include one or more electrodes or other sensors (e.g., pressure sensors, accelerometers, gyroscopes, microphones, etc.) powered by a power source within the device. The leads, the implantable medical device, or a combination thereof, can be configured to detect physiological information from the patient or to provide the patient with one or more therapies or stimulations.

[0006] Drilling assemblies include various numbers and configurations of electrical contacts for transmitting electrical signals to and from implantable medical devices, such as between the electronic circuitry of the implantable medical device and one or more electrodes coupled to one or more leads, depending on the type of medical device, the function performed by the medical device, and the specific leads to be coupled. In some examples, individual drilling assemblies may include multiple independent components stacked and connected in various configurations to form multiple different stacked drills with different desired physical and electrical configurations. The inventors have recognized, among other things, the need to reduce stacking tolerances in different combinations of multi-component stacked drills to reduce the cost and complexity of manufacturing and assembling medical device drilling assemblies, medical device heads, and general medical devices. Summary of the Invention

[0007] A system and method are disclosed for absorbing a portion of a positive or negative manufacturing tolerance of at least one component of a stacked drilling assembly, the stacked drilling assembly including a first component having a distal mechanical feature and a second component having a proximal mechanical feature, the proximal mechanical feature of the second component being configured to engage the distal mechanical feature of the first component with a shoulder located on either the distal mechanical feature of the first component or the proximal mechanical feature of the second component. The shoulder may be positioned at a distance from the end of either the distal mechanical feature of the first component or the proximal mechanical feature of the second component, the distance being either shorter or longer than the length of the other.

[0008] A stacked drilling assembly may include multiple components assembled to receive leads in the bores of the stacked drilling assembly and to be electrically connected to one or more electrical contacts on the leads after the leads are inserted into and secured in the bores of the stacked drilling assembly. In one example, a distal mechanical feature of a first component may be configured to engage a proximal mechanical feature of a second component to a shoulder located on the proximal mechanical feature of the second component, wherein the shoulder is positioned at a distance from the proximal end of the second component to absorb a portion of one of a positive or negative manufacturing tolerance of at least one of the first or second components, the distance being longer than the length of the distal mechanical feature of the first component. In another example, the distal mechanical feature of the first component can be configured to engage the proximal mechanical feature of the second component to a shoulder located on the proximal mechanical feature of the second component, wherein the shoulder is positioned at a distance from the proximal end of the second component to absorb a portion of one of the positive or negative manufacturing tolerances of at least one of the first or second components, the distance being longer than the length of the distal mechanical feature of the first component.

[0009] An example of this subject matter (e.g., a system) (e.g., "Example 1") may include a stacked drilling assembly comprising a plurality of components located between a proximal end and a distal end of the stacked drilling assembly. The stacked drilling assembly is configured to receive leads in a bore of the stacked drilling assembly and, after the leads are inserted into and secured in the bore of the stacked drilling assembly, electrically connect to one or more electrical contacts on the leads. The stacked drilling assembly includes a first component having a distal mechanical feature and a second component having a proximal mechanical feature. The side mechanical feature is configured to engage a distal mechanical feature of the first component with a shoulder located on one of the distal mechanical feature of the first component or the proximal mechanical feature of the second component, wherein the shoulder is positioned at a distance from the end of one of the distal mechanical feature of the first component or the proximal mechanical feature of the second component to absorb a portion of a positive or negative manufacturing tolerance of at least one of the first component or the second component, the distance being shorter or longer than the length of the other of the distal mechanical feature of the first component or the proximal mechanical feature of the second component.

[0010] In Example 2, the subject matter of Example 1 may optionally be configured such that the stacked drilling assembly is a component of the head of an implantable medical device including a housing containing an electronic circuitry system. A first component includes a first electrical contact to connect the first electronic circuitry of the housing's electronic circuitry system to the first electrical contact of the stacked drilling assembly. A second component includes a second electrical contact to connect the second electronic circuitry of the housing's electronic circuitry system to the second electrical contact of the stacked drilling assembly. The stacked drilling assembly is configured to receive a lead including the first and second electrical contacts. The first electrical contact of the lead is configured to connect to a first electrical contact of the first component of the stacked drilling assembly when the lead is inserted into and held by the stacked drilling assembly, and the second electrical contact of the lead is configured to connect to a second electrical contact of the second component of the stacked drilling assembly when the lead is inserted into and held by the stacked drilling assembly.

[0011] In Example 3, the subject matter of any one or more of Examples 1-2 may optionally be configured such that the distal mechanical feature of the first component includes a convex mechanical feature and the proximal mechanical feature of the second component includes a concave mechanical feature, the concave mechanical feature being configured to interference fit with the convex mechanical feature to a shoulder located on one of the convex or concave mechanical features.

[0012] In Example 4, the subject matter of any one or more of Examples 1-3 may optionally be configured such that the distal mechanical feature of the first component includes a concave mechanical feature and the proximal mechanical feature of the second component includes a convex mechanical feature, the convex mechanical feature being configured to interference fit with the concave mechanical feature to a shoulder located on one of the convex or concave mechanical features.

[0013] In Example 5, the subject matter of any one or more of Examples 1-4 may optionally be configured such that the second component includes a distal mechanical feature and the stacked drilling assembly includes a third component and a fourth component, the third component including a connector having proximal and distal mechanical features, and the fourth component including a proximal mechanical feature, wherein the connector is configured to engage the distal mechanical feature of the second component and the proximal mechanical feature of the fourth component between corresponding shoulders of the second and fourth components, wherein when the fourth component is connected to the second component via the third component, the connector has a length shorter or longer than the corresponding distance between the corresponding shoulders to absorb a portion of one of the positive or negative manufacturing tolerances of at least one of the second, third, or fourth components.

[0014] In Example 6, the subject matter of any one or more of Examples 1-5 may optionally be configured such that the connector includes a conductive material configured to be electrically connected to a second electrical contact of the second component when the connector is engaged with the second component, the second component including a core component made of an insulating material, the core component including internal mechanical features to position the second electrical contact of the second component to the electrical contact of the lead when the lead is inserted into and held by the stacked drilling assembly, wherein the insulating material of the second component is configured to electrically insulate the conductive material of the connector from the first electrical contact of the first component, and the fourth component includes a core component substantially similar to the second component.

[0015] In Example 7, the subject matter of any one or more of Examples 1-6 may optionally be configured such that the first component includes an end component located at the proximal end of the stacked drilling assembly, the end component being configured to receive and retain the proximal end of the lead after the lead is inserted into the stacked drilling assembly, and the stacked drilling assembly includes a plurality of core components connected by a plurality of connectors between the distal end of the stacked drilling assembly and the end component.

[0016] In Example 8, the subject matter of any one or more of Examples 1-7 may optionally be configured such that the distal mechanical feature of the second component includes a transition portion of mechanical engagement with the proximal end of the third component, from a sliding or transitional fit with the proximal mechanical feature of the third component when the third component engages with the second component at the distal end of the distal mechanical feature to an interference fit at the proximal end of the distal mechanical feature, wherein the length of the interference fit is greater than a positive or negative manufacturing tolerance of at least one of the second or third components.

[0017] In embodiment 9, the subject matter of any one or more of embodiments 1-8 may optionally be configured such that the shoulder is positioned at a distance from the edge of the distal mechanical feature of the first component to absorb a portion of the positive manufacturing tolerance of at least one of the first or second components, the distance being shorter than the length of the proximal mechanical feature of the second component.

[0018] In Example 10, the subject matter of any one or more of Examples 1-9 may optionally be configured such that the shoulder includes a first inner shoulder on a concave mating member at the distal end of the first component and a second outer shoulder on a convex mating member at the proximal end of the second component, wherein the first inner shoulder on the concave mating member at the distal end of the first component is positioned at a distance shorter than the length of the convex mating member at the proximal end of the second component to absorb a portion of a positive or negative manufacturing tolerance of at least one of the first or second components, and the length of the convex mating member at the proximal end of the second component includes the distance from the proximal end of the second component to the second outer shoulder on the convex mating member at the proximal end of the second component.

[0019] In Example 11, the subject matter of any one or more of Examples 1-10 may optionally be configured such that the shoulder includes a first inner shoulder on a concave mating member at the distal end of the first component and a second outer shoulder on a convex mating member at the proximal end of the second component, wherein the second outer shoulder on the convex mating member at the proximal end of the second component is positioned at a distance from the proximal end of the second component (longer than the length of the concave mating member at the distal end of the first component) to absorb a portion of a positive or negative manufacturing tolerance of at least one of the first or second components, and the length of the concave mating member at the distal end of the first component includes the distance from the distal end of the first component to the first inner shoulder on the concave mating member at the distal end of the first component.

[0020] In Example 12, the subject matter of any one or more of Examples 1-11 may optionally be configured such that the distance between the position of the second outer shoulder and the proximal end of the second component includes a positive or negative manufacturing tolerance of the aggregate of at least one of the first or second components relative to the plane defined by the first or second component.

[0021] In Example 13, the subject matter of any one or more of Examples 1-12 may optionally be configured such that the distance between the position of the second outer shoulder and the proximal end of the second component includes a positive or negative manufacturing tolerance of at least one of the concave mating part of the distal end of the first component or the convex mating part of the proximal end of the second component.

[0022] An example of this subject matter (e.g., a system) (e.g., “Example 14”) may include a stacked drilling assembly comprising a plurality of components configured to receive leads in bores of the stacked drilling assembly and to electrically connect to one or more electrical contacts on the leads after the leads are inserted into and secured in the bores of the stacked drilling assembly. The stacked drilling assembly includes a first component having a distal mechanical feature and a second component having a proximal mechanical feature, the proximal mechanical feature of the second component being configured to engage the distal mechanical feature of the first component, wherein the distal mechanical feature of the first component is configured to engage the proximal mechanical feature of the second component to a shoulder located on the proximal mechanical feature of the second component, and the shoulder is positioned at a distance from the proximal end of the second component to absorb a portion of one of a positive or negative manufacturing tolerance of at least one of the first or second components, the distance being longer than the length of the distal mechanical feature of the first component.

[0023] In Example 15, the subject matter of any one or more of Examples 1-14 may optionally be configured such that the second component includes a distal mechanical feature and the stacked drilling assembly includes a third component, the third component including a connector to engage the proximal mechanical feature of the fourth component and the distal mechanical feature of the second component between corresponding shoulders of the second and fourth components, wherein when the fourth component is connected to the second component via the third component, the connector has a length shorter or longer than the corresponding distance between the corresponding shoulders to absorb a portion of one of the positive or negative manufacturing tolerances of at least one of the second, third, or fourth components.

[0024] In Example 16, the subject matter of any one or more of Examples 1-15 may optionally be configured such that the first and third components include conductive materials to be coupled to corresponding feedthrough connections of the housing of the implantable medical device, and the second component includes an insulator to insulate the conductive material of the first component from the conductive material of the third component.

[0025] In Example 17, the subject matter of any one or more of Examples 1-16 may optionally be configured such that the first component includes an end component of the stacked drilling assembly, the second and fourth components include a core component of the stacked drilling assembly, the third component includes a connector, and the stacked drilling assembly includes a plurality of connectors and a plurality of core components located between the proximal and distal ends of the stacked drilling assembly, each connector and core component being substantially similar to the other corresponding connectors or core components.

[0026] In Example 18, the subject matter of any one or more of Examples 1-17 may optionally be configured to include a strain relief component at the distal end of the stacked drilling assembly, opposite the end component.

[0027] An example of this subject matter (e.g., a system) (e.g., “Example 19”) may include a stacked drilling assembly comprising a plurality of components configured to receive leads in bores of the stacked drilling assembly and to electrically connect leads to one or more electrical contacts after the leads are inserted into and secured in the bores of the stacked drilling assembly. The stacked drilling assembly includes a first component having a distal mechanical feature and a second component having a proximal mechanical feature. The proximal mechanical feature of the second component is configured to engage the distal mechanical feature of the first component with a shoulder located on the distal mechanical feature of the first component, wherein the shoulder is positioned at a distance from the distal end of the first component to absorb a portion of a positive or negative manufacturing tolerance of at least one of the first or second components, the distance being longer than the length of the proximal mechanical feature of the second component.

[0028] In Example 20, the subject matter of any one or more of Examples 1-19 may optionally be configured such that the second component includes a distal mechanical feature, the stacked drilling assembly includes a third component and a fourth component, the third component includes a connector having proximal and distal mechanical features, the fourth component includes a proximal mechanical feature, and the connector is configured to engage the distal mechanical feature of the second component and the proximal mechanical feature of the fourth component between corresponding shoulders of the second and fourth components, wherein when the fourth component is connected to the second component via the third component, the connector has a distance greater than the corresponding distance between the corresponding shoulders. A shorter or longer length to absorb a portion of one of the positive or negative manufacturing tolerances of at least one of the second, third, or fourth components, and the distal mechanical feature of the second component includes a transition portion for mechanical engagement with the proximal end of the third component, wherein when the third component engages with the second component at the distal end of the distal mechanical feature, there is an interference fit from a sliding fit or transition fit with the proximal mechanical feature of the third component to the proximal end of the distal mechanical feature, wherein the length of the interference fit is greater than the positive or negative manufacturing tolerance of at least one of the second or third components.

[0029] This overview is intended to provide a general overview of the subject matter of this patent application. It is not intended to provide an exclusive or exhaustive interpretation of this disclosure. Detailed descriptions are included to provide further information about this patent application. Other aspects of this disclosure will become clear to those skilled in the art upon reading and understanding the following detailed description and viewing the accompanying drawings, which form a part of it, and none of the drawings should be considered limiting. Attached Figure Description

[0030] In drawings that are not necessarily drawn to scale, similar reference numerals may describe similar parts in different views. Similar reference numerals with different letter suffixes may indicate different instances of similar parts. The drawings generally illustrate the various embodiments discussed in this document by way of example rather than limitation.

[0031] Figure 1 An exemplary cross-section of a stacked drilling assembly for placement in the head of an implantable medical device is shown.

[0032] Figures 2-3 Different subsets of the components of the stacked drilling assembly are shown.

[0033] Figure 4 An exemplary implantable medical device including a stacked drilling assembly is shown.

[0034] Figure 5 An exemplary medical device system is shown.

[0035] Figure 6An exemplary patient management system and a portion of the environment in which the patient management system may run are shown.

[0036] Figure 7 An exemplary method is shown for assembling a stacked drilling assembly and subsequently assembling an implantable medical device.

[0037] Figure 8 A block diagram of an exemplary machine is shown, on which any or more of the techniques (e.g., methods) discussed herein can be executed. Detailed Implementation

[0038] Traditional wire holes (or wire ports, or wire connector cavities, etc.) consist of individual wire holes designed and configured for different combinations of leads, electrical contacts, and connectors for different leads and implantable medical devices. To service medical devices with different combinations of leads or wire holes, medical device manufacturers design, manufacture, stock, and service many different traditional wire holes for each corresponding combination of leads or wire holes at a high cost.

[0039] Compared to traditional wire drilling, multi-element stacked drilling assemblies (or stacked lead port assemblies, or stacked lead connector cavities, etc.) have been developed. These assemblies combine different components to form various arrangements of leads and implantable medical devices, reducing the amount of finished product that must be stocked for each combination and enabling the reuse of individual components in different combinations. Compared to traditional wire drilling, stacked drilling assemblies can reduce the overall manufacturing cost of implantable medical devices with different lead arrangements or combinations, while increasing the number of leads compatible with implantable medical devices.

[0040] However, each component in a multi-part stacked drill assembly has its own manufacturing tolerances. The combination of these individual tolerances can result in a larger total stack tolerance than conventional lead-drilled assemblies, potentially causing the stacked drill assembly to exceed specifications, requiring additional assembly steps or procedures, or higher tolerance manufacturing steps, thus reducing the efficiency of the stacked drill assembly. The inventors have recognized that, among other things, in some examples, the tolerances of the individual components can be biased towards one side of the assembly, leaving room for float or free space to reduce the total stack tolerance and keep the assembly configuration within specifications. Conventional tolerances are typically ± one amount, such as ±5 millisieverts (5 / 1000 inch), etc. Although tolerances are described herein as the same amount added or subtracted, in some examples, tolerances can be different amounts added or subtracted. In some examples, the offset tolerances in the physical design of the individual components (e.g., by adding strategic clearances to one or more components) can absorb one side of the conventional tolerances in a component or between two components, such that, for example, by adding 5 milliinch of free space or clearance to the design of a component, the final tolerance in the offset combination can be between 0 and 5 milliinches (or between -5 milliinches and 0, depending on the orientation), rather than ±5 milliinches, to absorb positive (or negative) tolerances in one or more other components, such as between two interference-fit components, as shown and described herein.

[0041] Such free space or gaps between components may be more advantageous than other methods of reducing stacking tolerances, such as improving manufacturing precision, custom-sized gaskets, or compressible seals. For example, improving precision and custom-sized gaskets increase unnecessary manufacturing costs and intervention steps, including measurements. Compressible seals add extra tolerances to themselves, require force, may break over time, do not bend linearly during compression, and exert a negative force that pushes the component away under compression.

[0042] Figure 1 An exemplary cross-section of a stacked drilling assembly 100 for placement in the head of an implantable medical device is shown. The stacked drilling assembly 100 includes a plurality of components that, when mechanically coupled, such as by means of sliding, pushing, or compressive engagement between convex and concave mechanical coupling features, align and assemble the components to form a drill hole for receiving and securing the proximal end of a lead and for electrically connecting to one or more electrical contacts on the lead after the lead is inserted into and secured in the drill hole of the stacked drilling assembly 100.

[0043] The stacked drilling assembly 100 includes a proximal end ( Figure 1 (left side) and distal end ( Figure 1(on the right side), the stacked drilling assembly includes multiple components, including a first component 101 (e.g., an end component) and a second component 102 (e.g., a core component). The first component is located at a proximal end and is coupled to the second component 102 located distal to the first component 101. The second component is coupled to a third component 103 (e.g., a connector) located distal to the second component 102. In this example, additional components (e.g., subsequent combinations of core components and connectors, such as fourth to seventh components 104-107) are used until an eighth component 108 (e.g., a strain relief component) is located at the distal end of the stacked drilling assembly 100. This eighth component includes a borehole opening 111 of the borehole, which continues through multiple components of the stacked drilling assembly 100 (e.g., one or more core components) back to the first component 101 (e.g., the end component).

[0044] Different components of the stacked drilling assembly 100 may include electrical contacts, or be composed of conductive material, separated by one or more insulators, and configured to enable one or more electrical contacts of the connected leads to be connected to one or more other contacts of a medical device including the stacked drilling assembly 100. For example, the stacked drilling assembly 100 may be a component of the head of an implantable medical device and may be configured to provide electrical connections between one or more electrical contacts of the leads and one or more electrical contacts or electronic circuitry of the implantable medical device, such as through one or more feedthrough pins, wires, or combinations thereof.

[0045] The first component 101 (e.g., an end component) may include various features for receiving and retaining the proximal end of the lead, including: a drilled end 113; an end cap 114 (e.g., a translucent end cap for confirming that the lead is fully inserted into the stacked drill assembly 100); a drilled retaining portion 112 coupled to a retaining channel 115 including a mechanical retaining feature (e.g., a set screw or fastener) accessible through an opening 116 in a collar 117 to secure the lead in the stacked drill assembly 100; and a seat 118 for receiving mechanical features (e.g., a shoulder) of the lead. In some examples, the first component 101 may be made of a conductive material or may include conductive portions for electrical connection to electrical contacts of the lead. In other examples, the first component 101 is made of an electrically insulating material and may optionally include one or more conductive portions or conductive materials, such as electrical contacts that contact the lead, mating surfaces for conductors connected to a feedthrough of an implantable medical device, etc.

[0046] The second component 102 (e.g., a core component) may be composed of an electrically insulating material to insulate one or more other conductors or conductive elements from the first component 101 (e.g., an end component) or a subsequent third component 103 (e.g., a connector), or to insulate the first component 101 from the third component 103. In some examples, the second component 102 may include different features to receive, isolate, or position one or more other components located near or in contact with different aspects of the lead (e.g., electrical contacts of the lead).

[0047] For example, the second component 102 may include a sealing portion 119 to electrically insulate or isolate the coupled leads or different portions or components of the stacked drilling assembly 100, suppressing fluid communication between different electrical contacts of the leads once the leads are inserted into the borehole, and providing an interference fit around the inserted leads at the sealing portion 119. In one example, the second component 102 may include a first slot 120 and a second slot 121 to receive and position electrical contacts of the inserted leads, and in some examples, conductive material (e.g., conductive beams) that are in physical and electrical contact with electrical contacts of one or more other components of the stacked drilling assembly (e.g., a third component 103, etc.).

[0048] In some examples, the first component 101 may include one or more mechanical features (e.g., distal mechanical features) to engage and connect with one or more corresponding mechanical features (e.g., proximal mechanical features) of the second component 102. For example, the distal end of the first component 101 may include one of a concave mating part (hole) or a convex mating part (shaft), and the proximal end of the second component 102 may include a corresponding convex mating part or a concave mating part to engage the mating part at the distal end of the first component 101.

[0049] exist Figure 1 In this design, the distal end of the first component 101 includes a concave mating member having a length (e.g., depth) limited by an inner shoulder (shown at portion 130). The proximal end of the second component 102 includes a convex mating member having a first length from the proximal end of the second component 102 limited by a first outer shoulder (shown at portion 131). The convex mating member of the second component can engage the concave mating member of the first component 101 up to or near the inner shoulder of the first component 101 (shown at portion 130) or the first outer shoulder of the second component 102 (shown at portion 131).

[0050] The distal end of the second component 102 includes a convex mating member having a second length, defined by a second outer shoulder (shown at portion 132), extending from the distal end of the second component 102. In some examples, the second length of the second component 102 is longer than the first length to accommodate the first slot 120 and the second slot 121 and to electrically engage with the third component 103 at or near the midpoint of the third component 103. The convex mating member at the distal end of the second component 102 may engage a concave mating member at the proximal end of the third component 103 (e.g., a connector) up to or near the second outer shoulder (shown at portion 132) and adjacent to the proximal ends of one or more other components (e.g., the proximal end of the convex mating member of the fourth component 104, such as...). Figure 1 As shown in the figure, etc., it is shown in section 133.

[0051] The third component 103 (e.g., a connector) may include a proximal concave mating component and a distal concave mating component having a length between the proximal and distal ends, configured to engage and connect with a series of convex mating components of the second component 102 up to the second outer shoulder of the second component 102 (shown at portion 132) and one or more other components (e.g., a fourth component 104, an eighth component 108, etc.). In some examples, the third component 103 may be composed of a conductive material or may include conductive portions for electrical connection to electrical contacts of leads to provide mating surfaces for conductors connected to a feedthrough of an implantable medical device, etc.

[0052] Figure 1 Examples include fourth components 104 and sixth components 106, which are substantially similar to second component 102, and fifth components 105 and seventh components 107, which are substantially similar to third component 103. In some examples, fourth component 104 may include sealing portion 122 and slots 123, 124, and sixth component 106 may include sealing portion 125 and slots 126, 127, similar to sealing portion 119 and slots 120, 121, etc., of second component 102. In other examples, more or fewer core components or connectors may be included.

[0053] The fourth component 104 (e.g., the core component) may include a proximal convex mating component and a distal convex mating component, as well as a first outer shoulder and a second outer shoulder, shown at portions 134 and 135, respectively. The convex mating component at the proximal end of the fourth component 104 may engage a concave mating component at the distal end of the third component 103 up to or near the first outer shoulder of the fourth component 104 (shown at portion 134). The convex mating component at the distal end of the fourth component 104 may engage a concave mating component at the proximal end of the fifth component 105 (e.g., a connector), up to or near the second outer shoulder (shown at portion 135) and adjacent to the proximal ends of one or more other components (e.g., the proximal end of the convex mating component of the sixth component 106, such as...). Figure 1 As shown in the figure, etc., it is shown in section 136.

[0054] The fifth component 105 (e.g., a connector) may include a proximal concave mating component and a distal concave mating component having a length between the proximal and distal ends, configured to engage and connect with a series of convex mating components of the fourth component 104 up to the second outer shoulder of the fourth component 104 (shown at portion 135) and one or more other components (e.g., a sixth component 106, an eighth component 108, etc.). In some examples, the fifth component 105 may be composed of a conductive material or may include conductive portions for electrical connection to electrical contacts of leads to provide mating surfaces for conductors connected to a feedthrough of an implantable medical device, etc.

[0055] The sixth component 106 (e.g., the core component) may include a proximal convex mating component and a distal convex mating component, as well as a first outer shoulder and a second outer shoulder, shown at portions 137 and 138, respectively. The convex mating component at the proximal end of the sixth component 106 may engage the concave mating component at the distal end of the fifth component 105 up to or near the first outer shoulder of the sixth component 106 (shown at portion 137). The convex mating component at the distal end of the sixth component 106 may engage the concave mating component at the proximal end of the seventh component 107 (e.g., a connector), up to or near the second outer shoulder (shown at portion 138) and abutting the proximal ends of one or more other components (e.g., the proximal end of the convex mating component of the eighth component 108, such as...). Figure 1 As shown in the figure, etc., it is shown in section 139.

[0056] The seventh component 107 (e.g., a connector) may include a proximal concave mating component and a distal concave mating component having a length between the proximal and distal ends, configured to engage and connect with a continuous convex mating component of the sixth component 106 up to the second outer shoulder of the sixth component 106 (shown at portion 138) and one or more other components (e.g., an eighth component 108, etc.). In some examples, the seventh component 107 may be composed of a conductive material or may include conductive portions for electrical connection to electrical contacts of leads, providing mating surfaces, etc., for conductors connected to a feedthrough of an implantable medical device.

[0057] The eighth component 108 (e.g., a strain relief component) includes optional steps 109, 110 that transition to a borehole opening 111 that continues through multiple components of the stacked borehole assembly 100 back to the first component 101. In one example, the eighth component 108 may include a sealing portion 128, similar to the sealing portion 119 of the second component 102, etc.

[0058] The length of the stacked drilling assembly 100 can be determined by the spacing between different features of the stacked drilling assembly 100. Figure 1 The figures are shown as one or more different measurement results defined as lengths A1-A6 141-146. Some measurements must be controlled within certain tolerances to ensure the manufacturing and assembly integrity of the stacked drilled assembly 100 for integration into the head of an implantable medical device. For example, in conventional manufacturing practice, the length (e.g., depth) of the concave mating part of the first part 101 would correspond to the length of the convex mating part located at the proximal end of the second part 102, each with positive and negative tolerances. However, the worst case scenario could lead to the tolerances converging in one direction, causing the entire assembly to exceed specifications.

[0059] In one example, tolerances can be determined and controlled for different measurement results. For instance, a first plane 147 can be defined as a reference plane for the core component and connector component of the stacked drilling assembly 100, located between the inner shoulder of the first component 101 and one or more other planes of the stacked drilling assembly 100. A second plane 148 can be defined at the distal end of the second component 102, a third plane 149 can be defined at the distal end of the fourth component 104, a fourth plane 150 can be defined at the distal end of the sixth component 106, and a fifth plane 151 can be defined at the distal end of the eighth component 108.

[0060] Among other things, the inventors have also recognized techniques for reducing tolerance variations during the assembly of different lengths (e.g., A3-A6 143-146) between different planes, such as increasing strategic clearances by means of the length or position of different mating features (e.g., inner shoulder, outer shoulder, connector length, etc.) to strategically absorb one side of the conventional positive / negative tolerances of the parts or between the parts. In some examples, strategic clearances can be defined by the shoulders or lengths of different mechanical features, rather than being designed or configured without regard to positive or negative manufacturing tolerances (e.g., ±0 millimeters if manufacturing tolerances are ideal).

[0061] For example, at portion 131, the position of the first outer shoulder can be designed to have a first gap between the first outer shoulder of the second component 102 and the distal end (e.g., edge) of the first component 101 to absorb positive tolerances associated with the length (e.g., depth) of the concave mating part of the first component 101 and the first length of the convex mating part of the second component 102. In some examples, the design distance between the first outer shoulder of the second component 102 and the proximal end (e.g., edge) of the second component 102 (e.g., the length of the convex mating part located at the proximal end of the second component 102) can intentionally be larger than the distance between the inner shoulder of the first component 101 and the distal end of the first component 101 by the amount of one or more features, such as adding positive or negative tolerances to the concave mating part of the first component 101 or the convex mating part located at the proximal end of the second component 102. For example, the position of the distal end of the first component 101 and the position of the inner shoulder of the first component 101 can each have corresponding positive and negative tolerances. Similarly, the position of the proximal end of the second component 102 and the position of the first outer shoulder of the second component 102 can each have corresponding positive and negative tolerances. The first clearance can be designed relative to the first outer shoulder of the second component 102 located at portion 131 to absorb tolerances that may otherwise positively affect the overall length of the stacked drilling assembly 100, in some examples being equal to one or more of the positive or negative tolerances affecting the overall length.

[0062] In another example, the length of the third component 103 (between the proximal and distal ends of the third component 103) can be designed to have a second gap at one or both of the portions 132, 134, such that the positive tolerance associated with the third component 103 will not have a positive impact on the overall length of the stacked drilling assembly 100.

[0063] In one example, the distal end of the second component 102 may optionally include a transition of the mechanical fit at portion 152, such that the mechanical connection between the second component 102 and the third component 103 transitions from a sliding or transition fit to an interference fit at portion 152, allowing compression to stop during press-fit assembly of the stacked drill assembly 100 once the total length of the stacked drill assembly 100 reaches the desired amount. In some examples, additional clearances are designed to compress to a transition fit at portion 152, having one or more of the clearances described herein. In one example, the length of the interference fit at portion 152 may be greater than the positive or negative tolerance associated with the second, third, and fourth components 102-104, to absorb positive tolerances or provide additional length to compensate for negative tolerances, etc.

[0064] In another example, at part 133, the position of the distal end of the second part 102 or the proximal end of the fourth part 104 can be designed to have a third clearance to absorb the positive tolerance associated with one or both features.

[0065] Similar gaps are shown at subsequent portions of the fourth, fifth, sixth, and seventh components 104-107 as described above. Furthermore, the distal end of the eighth component 108 can be adjusted (e.g., cut, trim, or otherwise reduced) to provide the desired total length of the stacked drilling assembly 100. In some examples, different gaps or clearances can be designed, configured, and adjusted such that each of the second, third, fourth, and fifth planes 148-151 can remain within a specific tolerance range relative to the first plane 147, allowing the stacked drilling assembly 100 to comply with the tolerances expected of prior art single-piece drilling assemblies. Thus, although each of the second through fifth planes 148-151 may previously have ± a certain amount of build-in aggregate tolerance (e.g., ±5 millisieverts for the second plane 148, ±10 millisieverts for the third plane 149, etc.), adding gaps and clearances as described herein can limit tolerances between negative ranges and zero, absorbing positive tolerances through the gaps and clearances. In some examples, during assembly, if necessary, the aggregate negative tolerance associated with multiple components can be added to and adjusted (e.g., reduced) the length of the eighth component 108. However, during assembly, the stack is more likely not to be fully compressed than the aggregate negative tolerance causing the total length of the stacked drill assembly 100 to exceed specifications.

[0066] In some examples, multiple components can be press-fitted in a single step. In other examples, the core component (and one or more connectors, such as all connectors or all connectors except the last one connected to the strain relief section) can be press-fitted to the end component in a single step, wherein the strain relief section (and in some examples the last connector located between the last core component and the strain relief section) is press-fitted in a second step to ensure full contact between the core components, while the last one or more components are squeezed in the second step to control the desired total length (in the case of totality negative tolerances, selectively not fully squeezing the strain relief section to extend the length of the assembly, etc.).

[0067] Figure 2 This illustrates the press fit for assembly. Figure 1 The stacked drilling assembly 100 shown or a portion thereof previously included a first component subset 200 of separate first components, second components, third components, and fourth components 101-104.

[0068] The first component 101 has a first length B1 between its proximal and distal ends and a second length B2 proportional to the length (e.g., depth) of the concave mating component located at the distal end of the first component 101, the second length extending from the distal end of the first component 101 to the inner shoulder (e.g., at...). Figure 1 (This is shown at part 130).

[0069] The total length of the second component 102 is a combination of the following parts: the proximal end of the second component 102 and the first outer shoulder of the second component 102 (in Figure 1 The first length C1 between the portion 131 shown in the middle, the first outer shoulder and the second outer shoulder of the second component 102 (in the middle) Figure 1 The second length C2 between the portion 132 shown in the figure, and the third length C3 between the distal end of the second component 102 and the second outer shoulder of the second component 102.

[0070] The third component 103 has a length D1 between its proximal and distal ends, and the total length of the fourth component 104 is a combination of the first length, the second length, and the third lengths E1-E3, similar to the total length described with respect to the second component 102.

[0071] Figure 3 This illustrates the press fit for assembly. Figure 1 The stacked drilling assembly 100 shown, or a portion thereof, previously includes a second subset 300 of separate fifth, sixth, seventh, and eighth components 105-108.

[0072] The fifth and seventh components 105 and 107 have lengths F1 and H1 respectively between their proximal and distal ends. The total length of the sixth component 106 is a combination of the first length, the second length, and the third lengths G1-G3, similar to... Figure 2 The total length described in relation to the second component 102.

[0073] The total length of the eighth component 108 is a combination of the following parts: a first length I1 between the proximal end of the eighth component 108 and the first outer shoulder of the eighth component 108, a second length I2 between the first outer shoulder and the second outer shoulder of the eighth component 108, and a third length I3 (including steps 109 and 110) between the distal end of the eighth component 108 and the second outer shoulder of the eighth component 108.

[0074] about Figures 2-3 The length of the gap or clearance, commensurate with the positive tolerances of one or more components, can be added to different lengths in different arrangements or combinations to achieve different objectives. For example, adding a gap to C1 (moving the outer shoulder to C2, effectively reducing C2) can absorb the positive tolerances associated with different aspects of the first or second components 101, 102. Reducing the length of C1 (from the proximal end of the second component 102) can absorb the positive tolerances associated with different aspects of the first and second components 101, 102. Adding a gap to C3 (moving the outer shoulder to C2, effectively reducing C2) can absorb the positive tolerances associated with different aspects of the second component 102 or the third component 103. Reducing the length of C3 (from the distal end of the second component 102) can absorb the positive tolerances associated with each of the second component 102 and the fourth component 104. Adding a gap to D1 (e.g., by effectively reducing the length of D1) can absorb the positive tolerances associated with different aspects of the second, third, or fourth components 102-104. The transition at part 152 can provide additional length, for example, by not completely squeezing the second, third, or fourth parts 102-104 together under negative tolerances. Similar gaps, clearances, or adjustments can be made to the fourth part 104 or the fifth through seventh parts 105-107.

[0075] Regarding the eighth component 108, adding a gap to I1 effectively reduces I2, absorbing the positive tolerances associated with different aspects of the seventh or eighth components 107, 108. Reducing the length of I1 can absorb the positive tolerances associated with different aspects of the seventh component 107 or the eighth component 108. In contrast, adding length to one or both of I2 or I3 can compensate for the negative gaps associated with one or more of the multiple stacked components. In other examples, before placing the stacked drilling assembly 100 in the position to be formed in the head, different components can be pressed together in one or more steps, for example, by one or more manufacturing processes (e.g., overmolding, etc.), to more clearly control the different lengths and planes of the stacked drilling assembly 100.

[0076] Although this article is Figures 1-3 The illustration shows a first component 101 with concave mechanical connection features, a second component 102 with two convex mechanical connection features, a third component 103 with two concave mechanical connection features, and so on. However, in practice, such features can be switched or changed as long as the end component and the core component can be mechanically connected to each other. In other examples, the concave and convex mechanical connection features described herein can be switched, or replaced by two convex (or concave) mechanical connection features on the proximal and distal ends. The core component and the connector can have one convex mechanical connection feature and one concave mechanical connection feature, or other arrangements or combinations thereof.

[0077] Figure 4 An exemplary implantable medical device 400 is shown, which includes an hermetically sealed housing 401, a head 402 having a first stacked drilling assembly 403 and a second stacked drilling assembly 404, a feedthrough 405 having one or more feedthrough pins or connectors, and first wires, second wires, third wires and fourth wires 406-409 configured to connect to different contacts of the first stacked drilling assembly 403.

[0078] The first wire 406 is configured to connect to the conductive surface or contact of the end component of the first stacked drilling assembly 403. The second, third, and fourth wires 407-409 are configured to connect to the corresponding conductive surfaces or contacts of the respective first, second, and third connectors of the stacked drilling assembly 403. Although in Figure 4 The wires are shown as terminating at the bottom surface of each component, but in practice, the wires can continue to contact the bottom or side surfaces of such components in various combinations or arrangements.

[0079] Additional wires (not shown) can be routed from other feedthrough pins or connectors of feedthrough 405 to different contacts of the second stacked drill assembly 404. In other examples, one or more additional components, such as an antenna, may be connected to one or more feedthrough pins or connectors. Furthermore, in other examples, feedthrough 405 may be located on the top portion of housing 401, one or more other sides of housing, or in various arrangements or combinations thereof.

[0080] Figure 5 An exemplary medical device system 500 is illustrated, such as an implantable medical device, a heart rhythm management (CRM) device, etc. In one example, one or more aspects of the exemplary system 500 may be components of or communicatively coupled to an implantable medical device, an insertable heart monitor, etc. The system 500 may be configured to monitor, detect, or treat various physiological conditions of the body, such as cardiac conditions associated with a reduced ability of the heart to adequately pump blood into the body, including heart failure, arrhythmia, asynchrony, etc., or one or more other physiological conditions, and in some examples, the system may be configured to provide electrical stimulation or one or more other therapies or treatments to a patient.

[0081] System 500 may include a single or multiple medical devices implanted in or otherwise positioned on or around a patient to monitor the patient’s physiological information using one or more sensors (such as sensor 501). In one example, sensor 501 may include one or more of the following: a respiratory sensor configured to receive respiratory information (e.g., respiratory rate, respiratory volume (tidal volume), etc.); an acceleration sensor (e.g., accelerometer, microphone, etc.) configured to receive cardiac acceleration information (e.g., cardiac vibration information, pressure waveform information, heart sound information, endocardial acceleration information, acceleration information, activity information, posture information, etc.); an impedance sensor (e.g., intrathoracic impedance sensor, transthoracic impedance sensor, etc.) configured to receive impedance information; a cardiac sensor configured to receive cardiac electrical information; an activity sensor configured to receive information about body movement (e.g., activity, steps, etc.); a posture sensor configured to receive posture or position information; a pressure sensor configured to receive pressure information; a volumetric sensor (e.g., photoplethysmography sensor, etc.); a chemical sensor (e.g., electrolyte sensor, pH sensor, anion gap sensor, etc.); a temperature sensor; a skin elasticity sensor; or one or more other sensors configured to receive physiological information of a patient.

[0082] The exemplary system 500 may include a signal receiver circuit 502 and an evaluation circuit 503. The signal receiver circuit 502 may be configured to receive physiological information from a patient (or group of patients) from a sensor 501. The evaluation circuit 503 may be configured to receive information from the signal receiver circuit 502 and use the received physiological information to determine one or more parameters (e.g., physiological parameters, stratification, etc.) or existing or altered patient conditions, as described herein. Among other things, the physiological information may also include cardiac electrical information, impedance information, respiratory information, heart sound information, activity information, posture information, temperature information, or one or more other types of physiological information.

[0083] In some examples, evaluation circuit 503 can aggregate information from multiple sensors or devices, use the information from each sensor or device individually or in combination to detect various events, update the detection status of one or more patients based on the information, and transmit messages or alarms to one or more remote devices indicating that one or more patients have been detected or that the information has been stored or transmitted, so that one or more additional processes or systems can use the stored or transmitted detection or information for one or more other reviews or processes.

[0084] Evaluation circuit 503 can be configured to provide output to a user, such as to a display or one or more other user interfaces, including scores, trends, alarms, or other indications. In other examples, evaluation circuit 503 can be configured to provide output to another circuit, machine, or process (such as treatment circuit 504 (e.g., cardiac resynchronization therapy (CRT) circuit, chemotherapy circuit, etc.)) to control, adjust, or stop treatment by a medical device, drug delivery system, etc., or otherwise modify one or more other aspects of a medical device system, such as one or more cardiac resynchronization therapy parameters, drug delivery, dosage determination, or recommendations. In one example, treatment circuit 504 may include one or more of stimulation control circuitry, cardiac stimulation circuitry, neural stimulation circuitry, dosage determination, or control circuitry. In other examples, treatment circuit 504 may be controlled by evaluation circuit 503 or one or more other circuits.

[0085] Figure 6 An exemplary patient management system 600 and a portion of the environment in which the patient management system 600 may operate are illustrated. The patient management system 600 can perform a range of activities, including remote patient monitoring and diagnosis of disease conditions. These activities can be performed near or close to the patient 601 (e.g., in the patient's home or office), via a centralized server (e.g., in a hospital, clinic, or doctor's office), or via a remote workstation (e.g., a secure wireless mobile computing device).

[0086] The patient management system 600 may include one or more mobile medical devices, an external system 605, and a communication link 611 that provides communication between the mobile medical devices and the external system 605. The mobile medical devices may include an implantable medical device (IMD) 602, a wearable medical device 603, or one or more other implantable, leadless, subcutaneous, external, wearable, or mobile medical devices configured to monitor, sense, or detect information from the patient 601, determine physiological information about the patient, or provide one or more therapies to treat various conditions of the patient, such as one or more cardiac or non-cardiac conditions (e.g., dehydration, sleep apnea, etc.).

[0087] In one example, the implantable medical device 602 may include one or more conventional heart rhythm management devices implanted in the chest of a patient, having a lead system comprising one or more transvenous, subcutaneous, or non-invasive leads or catheters to position one or more electrodes or other sensors (e.g., heart sound sensors) in, on, or around the heart or in one or more other locations in the chest, abdomen, or neck of the patient 601. In another example, the implantable medical device 602 may include, for example, a monitor subcutaneously implanted in the chest of the patient 601, and the implantable medical device 602 includes a housing containing a circuitry and, in some examples, one or more sensors (e.g., temperature sensors).

[0088] Traditional heart rhythm management devices (such as insertable heart monitors, pacemakers, defibrillators, or cardiac resynchronizers) include implantable or subcutaneous devices with an airtight housing configured to be implanted in a patient's chest. Heart rhythm management devices may include one or more leads to position one or more electrodes or other sensors at various locations in or near the heart, such as in one or more of the atria or ventricles of the heart, etc. Therefore, heart rhythm management devices may include aspects located subcutaneously but close to the patient's distal skin, and aspects located near one or more of the patient's organs (such as leads or electrodes). Separate from or in addition to one or more electrodes or other sensors on the leads, heart rhythm management devices may include one or more electrodes or other sensors (e.g., pressure sensors, accelerometers, gyroscopes, microphones, etc.) powered by a power source within the heart rhythm management device. The one or more electrodes or other sensors on the leads, the heart rhythm management device, or combinations thereof may be configured to detect physiological information from the patient or to provide the patient with one or more therapies or stimulations.

[0089] Implantable devices may additionally or separately include leadless pacemakers (LCPs), small (e.g., smaller than conventional implantable rhythm management devices, having a volume of approximately 1 cc in some examples), and stand-alone devices comprising one or more sensors, circuitry, or electrodes configured to monitor physiological information from the heart (e.g., heart rate), detect cardiac-associated physiological conditions (e.g., tachycardia), or provide one or more therapies or stimulations to the heart without the complications of conventional leaded or implantable rhythm management devices (e.g., required incisions and recesses, complications associated with lead placement, breakage, or displacement, etc.). In some examples, leadless pacemakers may have more limited power and processing capabilities than conventional rhythm management devices; however, multiple leadless pacemakers may be implanted in or around the heart to detect physiological information from one or more chambers of the heart or to provide one or more therapies or stimulations to one or more chambers of the heart. Multiple leadless pacemakers may communicate with each other or with one or more other implantable or external devices.

[0090] The implantable medical device 602 may include assessment circuitry configured to detect or determine specific physiological information of the patient 601, or to determine one or more conditions, or to provide information or alerts to users (such as the patient 601, a clinician, or one or more other caregivers or processes), as described herein. The implantable medical device 602 may alternatively or additionally be configured as a treatment device, configured to treat one or more medical conditions of the patient 601. Treatment may be delivered to the patient 601 via a lead system and associated electrodes or using one or more other delivery mechanisms. Treatment may include delivering one or more medications to the patient 601, such as using the implantable medical device 602 or other mobile medical devices. In some examples, treatment may include cardiac resynchronization therapy to correct asynchrony and improve cardiac function in patients with heart failure. In other examples, the implantable medical device 602 may include a drug delivery system (such as a drug infusion pump) to deliver medication to a patient for managing arrhythmias or complications arising from arrhythmias, hypertension, hypotension, or one or more other physiological conditions. In other examples, the implantable medical device 602 may include one or more electrodes configured to stimulate the patient's nervous system or to provide stimulation to the muscles of the patient's airway.

[0091] Wearable medical device 603 may include one or more wearable or external medical sensors or devices (e.g., automated external defibrillator (AED), Holter monitor, patch-based device, smartwatch, smart accessory, wrist-worn or finger-worn medical device, such as finger-based photoplethysmography sensor, etc.).

[0092] External system 605 may include dedicated hardware / software systems, such as a programmer, a remote server-based patient management system, or alternatively, a software-defined system primarily running on a standard personal computer. External system 605 may manage patient 601 via an implantable medical device 602 or one or more other mobile medical devices connected to external system 605 via communication link 611. In other examples, implantable medical device 602 may be connected to wearable medical device 603, or wearable medical device 603 may be connected to external system 605 via communication link 611. This may include, for example, programming implantable medical device 602 to perform one or more of the following: acquiring physiological data, performing at least one self-diagnostic test (e.g., for device operational status), analyzing physiological data, or optionally delivering or adjusting treatment to patient 601. Additionally, external system 605 may send or receive information from implantable medical device 602 or wearable medical device 603 via communication link 611. Examples of information may include real-time or stored physiological data from patient 601, diagnostic data such as monitoring patient hydration status, hospitalization status, and response to treatments delivered to patient 601, or device operational status (e.g., battery status, lead impedance, etc.) of implantable medical device 602 or wearable medical device 603. Communication link 611 may be an inductive telemetry link, a capacitive telemetry link, or a radio frequency (RF) telemetry link, or wireless telemetry based on standards such as “Strong” Bluetooth or IEEE 602.11 Wireless Fidelity “Wi-Fi” interface standards. Other configurations and combinations of patient data source interfaces are also possible.

[0093] External system 605 may include an external device 606 located near one or more mobile medical devices and a remote device 608 located relatively far from one or more mobile medical devices, the remote device communicating with external device 606 via communication network 607. Examples of external device 606 may include a medical device programmer. Remote device 608 may be configured to evaluate collected patient or patient information and provide alarm notifications, among other possible functions. In one example, remote device 608 may include a centralized server acting as a central hub for storing and analyzing data collected from multiple different sources. The combination of information from multiple sources may be used to make decisions and update the status of individual patients or adjust one or more alarms or decisions for one or more other patients. The server may be configured as a single, multiple, or distributed computing and processing system. Remote device 608 may receive data from multiple patients. Data may be collected by one or more mobile medical devices and other data acquisition sensors or devices associated with patient 601. The server may include memory devices to store data in a patient database. The server may include alarm analyzer circuitry to evaluate the collected data to determine whether specific alarm conditions are met. Meeting alarm conditions can trigger the generation of alarm notifications, which can be provided by one or more human-perceptible user interfaces. In some examples, alarm conditions may be evaluated alternatively or additionally by one or more mobile medical devices (such as implantable medical devices). For example, alarm notifications may include web page updates, telephone or pager calls, emails, text messages, text or "instant" messages, as well as messages to patients and direct notifications to emergency services and clinicians simultaneously. Other alarm notifications are also possible. The server may include alarm priority ordering circuitry configured to prioritize alarm notifications. For example, alarms for detected medical events can be prioritized using a similarity metric between physiological data associated with the detected medical event and physiological data associated with historical alarms.

[0094] Remote device 608 may additionally include one or more locally configured clients or remote clients securely connected to the server via communication network 607. Examples of clients may include personal desktop computers, laptops, mobile devices, or other computing devices. System users (such as clinicians or other qualified medical professionals) can use the clients to securely access stored patient data aggregated in a database on the server and select and prioritize patients and alerts to provide healthcare. In addition to generating alert notifications, remote device 608, including the server and interconnected clients, can also execute follow-up protocols by sending follow-up requests to one or more mobile healthcare devices or by sending messages or other communications as compliance notifications to patients 601 (e.g., patients), clinicians, or authorized third parties.

[0095] The communication network 607 can provide wired or wireless interconnection. In one example, the communication network 607 can be based on the Transmission Control Protocol / Internet Protocol (TCP / IP) network communication specification, although other types or combinations of network implementations are also possible. Similarly, other network topologies and arrangements are also possible.

[0096] One or more of the external device 606 or remote device 608 may output detected medical events to a system user (such as a patient or clinician) or to an instance including, for example, a computer program executable in a microprocessor. In one example, the process may include automatically generating recommendations for antiarrhythmic treatment or for further diagnostic testing or treatment. In one example, the external device 606 or remote device 608 may include a corresponding display unit for displaying physiological or functional signals, or alarms, warnings, emergency calls, or other forms of alerts signaling the detection of an arrhythmia. In some examples, the external system 605 may include an external data processor configured to analyze physiological or functional signals received by one or more mobile medical devices and to confirm or reject the detection of an arrhythmia. Computationally intensive algorithms (such as machine learning algorithms) may be implemented in the external data processor to retrospectively process the data for arrhythmia detection.

[0097] One or more portions of a mobile medical device or external system 605 may be implemented using hardware, software, firmware, or a combination thereof. Portions of one or more mobile medical devices or external systems 605 may be implemented using dedicated circuitry that can be constructed or configured to perform one or more functions, or using general-purpose circuitry that can be programmed or otherwise configured to perform one or more functions. Such general-purpose circuitry may include a microprocessor or a portion thereof, a microcontroller or a portion thereof, or programmable logic circuitry, memory circuitry, network interfaces, and various components for interconnecting these components. For example, among other things, a “comparator” may include an electronic circuit comparator that can be constructed to perform a specific function of comparing two signals, or a comparator may be implemented as part of a general-purpose circuitry that can be driven by code instructing a portion of the general-purpose circuitry to perform a comparison between two signals. A “sensor” may include electronic circuitry configured to receive information and provide an electronic output representing such received information.

[0098] The patient management system 600 may include a treatment device 610, such as a mobile or external treatment device, configured to send or receive information from one or more of the mobile medical devices or external systems 605 via a communication link 611. In one example, one or more mobile medical devices, external devices 606, or remote devices 608 may be configured to control one or more parameters of the treatment device 610. The external system 605 may allow programming of one or more mobile medical devices and may receive (e.g., via the communication link 611) information about one or more signals acquired by one or more mobile medical devices. The external system 605 may include a local external implantable medical device programmer. The external system 605 may include a remote patient management system, which may monitor patient status or adjust one or more therapies from a remote location.

[0099] Figure 7 An exemplary method 700 is shown for assembling a stacked drilling assembly and subsequently assembling an implantable medical device.

[0100] In step 701, different components of the stacked drilling assembly are manufactured, each component including its own mechanical feature. The different components may include end components, one or more core components, one or more connectors, and strain relief sections, as described otherwise herein. A first component may include a distal mechanical feature, and a second component may include a proximal mechanical feature configured to engage the distal mechanical feature of the first component.

[0101] In step 702, the shoulder of the distal mechanical feature of the first component may optionally be positioned at a distance from the distal end of the first component to absorb at least a portion of the manufacturing tolerances of one or more components of the stacked drilling assembly (e.g., one or more features of the first or second component, a distal mechanical feature of the first component, or a proximal mechanical feature of the second component, etc.), the distance being longer or shorter than the length of the proximal mechanical feature of the second component. For example, positioning the shoulder of the distal mechanical feature of the first component may include adding gaps or voids to absorb positive manufacturing tolerances associated with the length of the proximal mechanical feature of the second component or the length of the distal mechanical feature of the first component itself, such that positive tolerances associated with such components will not increase the total stack length of the assembled stacked drilling assembly. In other examples, one or more additional gaps or voids or lengths may be added to one or more components to further reduce one or both of the positive or negative manufacturing tolerances of the stacked drilling assembly.

[0102] In step 703, optionally, the shoulder of the proximal mechanical feature of the second component may be positioned at a distance from the proximal end of the second component to absorb at least a portion of the manufacturing tolerances of one or more components of the stacked drilling assembly (such as one or more features of the first or second component, a remote mechanical feature of the first component, or one or more proximal mechanical features of the second component, etc.), the distance being longer or shorter than the length of the distal mechanical feature of the first component. For example, positioning the shoulder of the proximal mechanical feature of the second component may include adding gaps or voids to absorb positive manufacturing tolerances associated with the length of the distal mechanical feature of the first component or the length of the proximal mechanical feature of the second component itself, such that positive tolerances associated with such components will not increase the total stack length of the assembled stacked drilling assembly.

[0103] In step 704, the stacked drilling assembly can be assembled, including multiple components of the stacked drilling assembly optionally press-fitted in one or more steps in step 705, as described herein. For example, in a first step, a first component and a second component can be placed near each other and press-fitted, while in one or more additional steps, other components can be engaged with the first and second components. In one example, each component can be press-fitted in a separate step and measured to ensure assembly within tight manufacturing tolerances. In another example, all major components of the stacked drilling assembly (e.g., components 101-108, etc.) can be assembled in a single press-fitting step, for example, using a machine or process. In some examples, the total stack length of the stacked drilling assembly or one or more of the different planes can be measured during or after the assembly of the stacked drilling assembly.

[0104] In step 706, once the stacked drilling assembly is complete, it can be attached to the housing, for example, by connecting one or more electrical contacts of the stacked drilling assembly to one or more feedthrough connectors located on the housing of the implantable medical device. After attaching the stacked drilling assembly to the housing, the implantable medical device can be assembled, for example, by forming a head, including epoxy treatment of multiple parts of the head to protect different components and the subject, and overmolding the head into the implantable medical device.

[0105] Figure 8A block diagram of an exemplary machine 800 is shown, on which any or more of the techniques (e.g., methods) discussed herein can be executed. Parts of this specification can be applied to one or more computational frameworks in medical devices described herein (e.g., implantable medical devices, external programmers, etc.). Furthermore, as described herein with respect to medical device components, systems, or machines, this may require regulatory compliance that cannot be met by ordinary computers, components, or machinery.

[0106] As described herein, examples may include logic or multiple components or mechanisms in machine 800 or operable therefrom. A circuit system (e.g., a processing circuit system, an evaluation circuit, etc.) is a collection of circuits implemented in the tangible entity of machine 800, which includes hardware (e.g., simple circuits, gates, logic, etc.). Over time, the members of a circuit system may become flexible. A circuit system includes members that can perform a specified operation individually or in combination during operation. In one example, the hardware of a circuit system may be designed immutably to perform a specific operation (e.g., hardwired). In one example, the hardware of a circuit system may include physically connected components (e.g., execution units, transistors, simple circuits, etc.) including physically modified machine-readable media (e.g., magnetically, electrically, movable placement of immutable aggregated particles, etc.) to encode instructions for a specific operation. When the physical components are connected, the underlying electrical characteristics of the hardware components change, for example, from an insulator to a conductor, and vice versa. Instructions enable embedded hardware (e.g., execution units or loading mechanisms) to form members of a circuit system in the hardware via variable connections to perform a portion of a specific operation during operation. Therefore, in one example, the machine-readable medium element is part of a circuit system, or communicatively coupled to other components of the circuit system during device operation. In one example, any physical component can be used in more than one member of more than one circuit system. For example, under operation, an execution unit may be used at one point in time in a first circuit of a first circuit system and reused at a different time by a second circuit in the first circuit system or a third circuit in the second circuit system. Additional examples of these components of machine 800 are as follows.

[0107] In alternative embodiments, machine 800 may operate as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, machine 800 may operate as a server machine, a client machine, or both in a server-client network environment. In one example, machine 800 may act as a peer-to-peer (P2P) (or other distributed) network environment. Machine 800 may be a personal computer (PC), tablet computer, set-top box (STB), personal digital assistant (PDA), mobile phone, network device, network router, switch, or bridge, or any machine capable of executing instructions (sequentially or otherwise) specifying the actions to be taken by the machine. Furthermore, although only a single machine is shown, the term "machine" should also be considered to include any collection of machines that independently or jointly execute a set (or more) of instructions to perform any of the methods discussed herein, such as cloud computing, Software as a Service (SaaS), and other computer cluster configurations.

[0108] Machine (e.g., computer system) 800 may include a hardware processor 802 (e.g., a central processing unit (CPU), graphics processing unit (GPU), hardware processor core, or any combination thereof), main memory 804, static memory (e.g., memory or storage device for firmware, microcode, basic input / output (BIOS), unified extensible firmware interface (UEFI), etc.) 806, and mass storage device 808 (e.g., hard disk drive, tape drive, flash memory, or other block device), some or all of which may communicate with each other via interconnect (e.g., bus) 830. Machine 800 may further include a display unit 810, an input device 812 (e.g., keyboard), and a user interface (UI) navigation device 814 (e.g., mouse). In one example, display unit 810, input device 812, and UI navigation device 814 may be a touchscreen display. Machine 800 may additionally include a signal generation device 818 (e.g., speaker), a network interface device 820, and one or more sensors 816, such as a global positioning system (GPS) sensor, a compass, an accelerometer, or one or more other sensors. Machine 800 may include output controller 828, such as serial (e.g., Universal Serial Bus (USB), parallel, or other wired or wireless (e.g., infrared (IR), near field communication (NFC) etc.)) connection, to communicate or control one or more peripheral devices (e.g., printer, card reader, etc.).

[0109] The registers of the hardware processor 802, main memory 804, static memory 806, or mass storage device 808 may be or include a machine-readable medium 822 on which one or more sets of data structures or instructions 824 (e.g., software) embodying or utilized by any one or more of the techniques or functions described herein are stored. During execution of the instructions 824 by the machine 800, the instructions may also reside wholly or at least partially within any register of the hardware processor 802, main memory 804, static memory 806, or mass storage device 808. In one example, one or any combination of the hardware processor 802, main memory 804, static memory 806, or mass storage device 808 may constitute the machine-readable medium 822. Although the machine-readable medium 822 is shown as a single medium, the term "machine-readable medium" may include a single medium or multiple media (e.g., a centralized or distributed database and / or associated caches and servers) configured to store one or more instructions 824.

[0110] The term "machine-readable medium" can include any medium capable of storing, encoding, or carrying instructions executable by machine 800 and causing machine 800 to perform any or more of the technologies disclosed herein, or any medium capable of storing, encoding, or carrying data structures used by or associated with such instructions. Examples of non-limiting machine-readable media can include solid-state memory, optical media, magnetic media, and signals (e.g., radio frequency signals, other photon-based signals, sound signals, etc.). In one example, a non-transient machine-readable medium includes a machine-readable medium having a plurality of particles with invariant mass (e.g., stationary) and is therefore a composition of matter. Thus, a non-transient machine-readable medium is a machine-readable medium that does not include transiently propagating signals. Specific examples of non-transient machine-readable media may include: non-volatile memory, such as semiconductor memory devices (e.g., electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.

[0111] Instruction 824 can be further transmitted or received via a communication network 826 using a transmission medium via network interface device 820, utilizing any of a variety of transport protocols (e.g., Frame Relay, Internet Protocol (IP), Transmission Control Protocol (TCP), User Datagram Protocol (UDP), Hypertext Transfer Protocol (HTTP), etc.). Exemplary communication networks may include local area networks (LANs), wide area networks (WANs), packet data networks (e.g., the Internet), mobile phone networks (e.g., cellular networks), conventional telephone (POTS) networks, and wireless data networks (e.g., the IEEE 802.11 family of standards known as Wi-Fi®, the IEEE 802.16 family of standards known as WiMax®), the IEEE 802.15.4 family of standards, peer-to-peer (P2P) networks, and so on. In one example, network interface device 820 may include one or more physical jacks (e.g., Ethernet, coaxial, or telephone jacks) or one or more antennas for connection to communication network 826. In one example, network interface device 820 may include multiple antennas to enable wireless communication using at least one of single-input multiple-output (SIMO), multiple-input multiple-input (MIMO), or multiple-input single-output (MISO) technologies. The term "transmission medium" should be considered to include any intangible medium capable of storing, encoding, or carrying instructions executable by machine 800, and includes digital or analog communication signals or other intangible media to facilitate communication of such software. The transmission medium is a machine-readable medium.

[0112] Various embodiments are illustrated in the figures above. One or more features from these embodiments can be combined to form other embodiments. Examples of methods described herein can be implemented at least in part by a machine or computer. Some examples may include computer-readable or machine-readable media encoded with instructions operable to configure an electronic device or system to perform the methods described in the examples above. Implementations of such methods may include code, such as microcode, assembly language code, high-level language code, etc. Such code may include computer-readable instructions for performing various methods. The code may form part of a computer program product. Furthermore, the code may be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times.

[0113] The detailed description above is intended to be illustrative and not restrictive. Therefore, the scope of this disclosure should be determined by reference to the appended claims and the full scope of their equivalents.

Claims

1. A system comprising: A stacked drilling assembly includes a plurality of components located between a proximal end and a distal end of the stacked drilling assembly, the stacked drilling assembly being configured to receive a lead in a bore of the stacked drilling assembly and to electrically connect the lead to one or more electrical contacts thereon after the lead is inserted into and secured in the bore of the stacked drilling assembly, the stacked drilling assembly comprising: A first component, the first component including a distal mechanical feature; and The second component includes a proximal mechanical feature configured to engage a distal mechanical feature of the first component with a shoulder located on either the distal mechanical feature of the first component or the proximal mechanical feature of the second component. The shoulder is positioned at a distance from the end of one of the distal mechanical features of the first component or the proximal mechanical feature of the second component to absorb a portion of the positive or negative manufacturing tolerance of at least one of the first component or the second component, the distance being shorter or longer than the length of the other of the distal mechanical feature of the first component or the proximal mechanical feature of the second component.

2. The system according to claim 1, wherein, The stacked drilling assembly is a component of the head of an implantable medical device. The implantable medical device includes a housing, and the housing includes an electronic circuit system. The first component includes a first electrical contact to connect the first electronic circuitry of the electronic circuitry system of the housing of the implantable medical device to the first electrical contact of the stacked drilling assembly. The second component includes a second electrical contact to connect the second electronic circuitry of the electronic circuitry system of the housing of the implantable medical device to the second electrical contact of the stacked drilling assembly. The stacked drilling assembly is configured to receive a lead including a first electrical contact and a second electrical contact, wherein when the lead is inserted into and held in the stacked drilling assembly, the first electrical contact of the lead is configured to be connected to a first electrical contact of a first component of the stacked drilling assembly, and wherein when the lead is inserted into and held in the stacked drilling assembly, the second electrical contact of the lead is configured to be connected to a second electrical contact of a second component of the stacked drilling assembly.

3. The system according to any one of claims 1 to 2, wherein, The distal mechanical feature of the first component includes a convex mechanical feature. The proximal mechanical feature of the second component includes a concave mechanical feature configured to be interference-fitted with the convex mechanical feature to a shoulder located on either the convex or concave mechanical feature.

4. The system according to any one of claims 1 to 2, wherein, The distal mechanical feature of the first component includes a concave mechanical feature. The proximal mechanical feature of the second component includes a convex mechanical feature configured to be interference-fitted with the concave mechanical feature to a shoulder located on one of the convex or concave mechanical features.

5. The system according to any one of claims 1 to 4, wherein, The second component includes a distal mechanical feature. The stacked drilling assembly includes: A third component, comprising a connector having proximal and distal mechanical features; and The fourth component includes a proximal mechanical feature. The connector is configured to engage a distal mechanical feature of the second component and a proximal mechanical feature of the fourth component between corresponding shoulders of the second component and the fourth component. When the fourth component is connected to the second component via the third component, the connector has a length shorter or longer than the corresponding distance between the corresponding shoulders to absorb a portion of a positive or negative manufacturing tolerance of at least one of the second component, the third component, or the fourth component.

6. The system according to claim 5, wherein, The connector includes a conductive material configured to be electrically connected to a second electrical contact of the second component when the connector is engaged with the second component. The second component includes a core component made of an insulating material, the core component including internal mechanical features to position a second electrical contact of the second component to an electrical contact of the lead when the lead is inserted into and held in the stacked drill assembly, wherein the insulating material of the second component is configured to electrically insulate the conductive material of the connector from the first electrical contact of the first component. The fourth component includes a core component that is substantially similar to the second component.

7. The system according to claim 6, wherein, The first component includes an end member located at the proximal end of the stacked drilling assembly, the end member being configured to receive and retain the proximal end of the lead after it has been inserted into the stacked drilling assembly. The stacked drilling assembly includes multiple core components, which are connected by multiple connectors between the distal end and the end component of the stacked drilling assembly.

8. The system according to claim 5, wherein, The distal mechanical feature of the second component includes a transition portion that mechanically engages with the proximal end of the third component, from a sliding fit or transition fit with the proximal mechanical feature of the third component when the third component engages with the second component at the distal end of the distal mechanical feature to an interference fit at the proximal end of the distal mechanical feature, wherein the length of the interference fit is greater than a positive or negative manufacturing tolerance of at least one of the second component or the third component.

9. The system according to any one of claims 1 to 2, wherein, The shoulder is positioned at a distance from the edge of the distal mechanical feature of the first component to absorb a portion of the positive manufacturing tolerance of at least one of the first or second components, the distance being shorter than the length of the proximal mechanical feature of the second component.

10. The system according to any one of claims 1 to 2, wherein, The shoulder includes: A first inner shoulder, the first inner shoulder being located on a concave mating member at the distal end of the first component; and The second outer shoulder is located on the convex mating part at the proximal end of the second component. Wherein, the first inner shoulder on the concave mating part at the distal end of the first component is positioned at a shorter distance than the length of the convex mating part at the proximal end of the second component, so as to absorb a portion of the positive or negative manufacturing tolerance of at least one of the first component or the second component. The length of the convex mating member at the proximal end of the second component includes the distance from the proximal end of the second component to the second outer shoulder located on the convex mating member at the proximal end of the second component.

11. The system according to any one of claims 1 to 2, wherein, The shoulder includes: A first inner shoulder, the first inner shoulder being located on a concave mating member at the distal end of the first component; and The second outer shoulder is located on the convex mating part at the proximal end of the second component. Wherein, the second outer shoulder on the convex mating component located at the proximal end of the second component is positioned at a certain distance from the proximal end of the second component to absorb a portion of the positive or negative manufacturing tolerance of at least one of the first component or the second component, said certain distance being longer than the length of the concave mating component at the distal end of the first component. Wherein, the length of the concave mating member at the distal end of the first component includes the distance from the distal end of the first component to the first inner shoulder located on the concave mating member at the distal end of the first component.

12. The system according to claim 11, wherein, The distance between the position of the second outer shoulder and the proximal end of the second component includes the positive or negative manufacturing tolerance of the sum of the properties of at least one of the first or second components relative to the plane defined by the first or second component.

13. The system according to claim 11, wherein, The distance between the position of the second outer shoulder and the proximal end of the second component includes the positive or negative manufacturing tolerance of at least one of the concave mating part of the distal end of the first component or the convex mating part of the proximal end of the second component.

14. A system comprising: A stacked drilling assembly comprising multiple components, the stacked drilling assembly being configured to receive leads in bores of the stacked drilling assembly and to electrically connect the leads to one or more electrical contacts after the leads are inserted into and secured in the bores of the stacked drilling assembly, the stacked drilling assembly comprising: A first component, the first component including a distal mechanical feature; and The second component includes a proximal mechanical feature configured to engage a distal mechanical feature of the first component. Wherein, the distal mechanical feature of the first component is configured to engage the proximal mechanical feature of the second component with a shoulder located on the proximal mechanical feature of the second component. The shoulder is positioned at a distance from the proximal end of the second component to absorb a portion of either a positive or negative manufacturing tolerance of the first or second component, the distance being longer than the length of the distal mechanical feature of the first component.

15. A system comprising: A stacked drilling assembly comprising multiple components, the stacked drilling assembly being configured to receive leads in bores of the stacked drilling assembly and to electrically connect the leads to one or more electrical contacts after the leads are inserted into and secured in the bores of the stacked drilling assembly, the stacked drilling assembly comprising: A first component, the first component including a distal mechanical feature; and The second component includes a proximal mechanical feature configured to engage a distal mechanical feature of the first component with a shoulder located on the distal mechanical feature of the first component. The shoulder is positioned at a distance from the distal end of the first component to absorb a portion of either a positive or negative manufacturing tolerance of the first component or the second component, the distance being longer than the length of the proximal mechanical feature of the second component.

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