Implantable pulse generator

Abstract

An implantable pulse generator and a method of manufacturing the implantable pulse generator are described. The implantable pulse generator includes a battery, a header, one or more connector receptacles, and an electronics module. The battery includes a battery housing, battery cell(s) within the battery housing, and power conductors provided on a first side of the battery housing. The header is mounted to the first side of the battery housing and includes a header body. The connector receptacle(s) are located within the header body and configured to electrically connect to one or more electrodes. The electronics module is located within the header body and is electrically connected to the connector receptacle(s) and to the battery via the power conductors. The electronics module includes circuitry for generating electrical stimulation that is conveyed via the connector receptacle(s) and the electrode(s) to patient tissue.

Description

IMPLANTABLE PULSE GENERATORCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 715,107 (filed 01 -November-2024), the entire disclosure of which is incorporated herein by reference.BACKGROUND

[0002] Examples of the present disclosure relate generally to medical devices designed to be implanted within patients, and more specifically to implantable medical devices (IMDs) that provide electrical stimulation therapy to tissue of a patient.

[0003] Some IMDs function to monitor activity of a patient and provide electrotherapy to patient tissue. The IMDs that provide electrotherapy to cardiac and / or neural (e.g., brain) tissue can be referred to as implantable pulse generators (IPGs). The IPGs can include pacemakers and implantable cardioverter defibrillators (ICDs), which are used in the treatment of cardiac conditions, and neuromodulators or neurostimulators, which are used in chronic pain management or the actuation and control of other body systems. The IPGs commonly include a housing, a feedthrough, and a header. The housing is commonly referred to as a can and may be hermetically sealed via the feedthrough. The header encloses a connector assembly for receiving the end of one or more implantable leads. The can encloses electrical circuitry and a power source. The header may mount to the feedthrough to establish an electrical connection between the connector assembly in the header and the electrical circuitry and power source in the can. The feedthrough may include individual conductors, such as ribbons, pins, or the like, which extend through an insulator. The power source may be a battery. The battery includes a battery housing that is discrete from the can of the IPG. For example, the battery and an electronics module may both be contained within the can.15899WO01 (013-0623PCT1 ) 1 PATENT

[0004] The electrical circuitry may control, among other things, sensing, pacing, and / or defibrillation performed by the IPG. For example, the electrical circuitry and power source in the can may generate pacing pulses that are electrically conveyed through the conductors of the feedthrough and the connector assembly of the header, along the length of the implantable leads to the cardiac tissue of the patient.

[0005] This conventional IPG design could benefit from modifications to increase the efficiency, reduce complexity, and reduce the cost to produce. Furthermore, modifications may be made to improve IPG performance at sensing electrical signals by reducing electrical interference. The IPG design may also benefit from a smaller form factor to be less noticeable in the patient.SUMMARY

[0006] In accordance with examples herein, an implantable pulse generator is provided that includes a battery, a header, one or more connector receptacles, and an electronics module. The battery includes a battery housing, one or more battery cells within the battery housing, and power conductors provided on a first side of the battery housing. The header is mounted to the first side of the battery housing and includes a header body. The one or more connector receptacles are located within the header body and are configured to electrically connect to one or more electrodes. The electronics module is located within the header body. The electronics module is electrically connected to the one or more connector receptacles and is electrically connected to the battery via the power conductors. The electronics module includes circuitry for generating electrical stimulation that is conveyed via the one or more connector receptacles and the one or more electrodes to patient tissue.

[0007] In an example, the electronics module within the header body includes a printed circuit board (PCB). The one or more connector receptacles are mounted on the PCB. The PCB may be planar. The PCB may be oriented in the15899WO01 (013-0623PCT1 ) 2 PATENTheader body so that a plane of the PCB is approximately perpendicular to the first side of the battery housing.

[0008] In an example, the implantable pulse generator includes a support frame that holds the electronics module and the one or more connector receptacles in fixed positions. The support frame may be mounted to the first side of the battery housing. The support frame may include at least one mounting bracket configured to secure to the battery housing via a fastener. The implantable pulse generator may include an antenna located within the header body. The support frame may include one or more protrusions that project from a wall of the support frame to hold the antenna.

[0009] In an example, each of the one or more connector receptacles may include annular electrical contacts alternating with insulating rings in a row. In an example, the power conductors of the battery may be pins that extend from the battery housing. The electronics module may include sockets configured to receive the power conductors during assembly to electrically connect the electronics module to the battery. The header body may seal an interface defined between the header and the battery. The header body may surround and engage a portion of the battery housing proximate to the first side of the battery housing to secure the header to the battery.

[0010] In an example, the implantable pulse generator may include one or more grounding conductors that are electrically connected to the battery housing and extend from the first side of the battery housing. The one or more grounding conductors may be electrically connected to the electronics module within the header body to selectively use the battery housing as an electrode. In an example, at least a portion of the battery housing may define an exterior surface of the implantable pulse generator. In an example, the battery housing includes titanium. The header body may include an epoxy material. The one or more connector receptacles may be configured to receive and electrically connect to one or more implantable leads inserted through one or more corresponding bores in the header15899WO01 (013-0623PCT1 ) 3 PATENTbody. The one or more electrodes may be located on the one or more implantable leads.

[0011] In accordance with examples herein, a method of manufacturing an implantable pulse generator is provided that includes assembling an electrical assembly by electrically connecting one or more connector receptacles to an electronics module. The one or more connector receptacles are configured to electrically connect to one or more electrodes. The electronics module includes circuitry for generating electrical stimulation that is conveyed via the one or more connector receptacles and the one or more electrodes to patient tissue. The method includes mounting the electrical assembly to a first side of a battery housing of a battery so that the electronics module is electrically connected to power conductors of the battery. The power conductors are provided on the first side of the battery housing. The method includes forming a header body to encase the electrical assembly and define a header that is secured to the battery.

[0012] In an example, the electronics module includes a printed circuit board (PCB), and assembling the electrical assembly involves mounting the one or more connector receptacles on the PCB. The electrical assembly may include a support frame. Assembling the electrical assembly may involve coupling the electronics module and the one or more connector receptacles to the support frame. The support frame may include at least one mounting bracket. Mounting the electrical assembly to the first side of the battery housing may involve installing at least one fastener through the at least one mounting bracket into the first side of the battery housing.

[0013] In an example, forming the header body to encase the electrical assembly may involve flowing a material of the header body in a flowable state in- situ to surround and conform to a contour of the electrical assembly. In an example, forming the header body may involve causing a material of the header body to seal an interface defined between the header and the battery and to15899WO01 (013-0623PCT1 ) 4 PATENTsurround and engage a portion of the battery housing proximate to the first side of the battery housing, to secure the header to the battery.

[0014] In accordance with examples herein, an implantable pulse generator is provided that includes a battery and a header. The battery includes a battery housing, one or more battery cells within the battery housing, and power conductors provided on a first side of the battery housing. The header is mounted to the first side of the battery housing. The header includes an electrical assembly encased in a header body. The electrical assembly includes one or more connector receptacles, an electronics module, and a support frame. The one or more connector receptacles are configured to receive and electrically connect to one or more implantable leads inserted through one or more corresponding bores in the header body. The electronics module is electrically connected to the battery via the power conductors. The electronics module includes a printed circuit board (PCB) electrically connected to the one or more connector receptacles. The electronics module includes circuitry for generating electrical stimulation that is conveyed via the one or more connector receptacles and the one or more implantable leads to patient tissue. The support frame couples to the PCB and the one or more connector receptacles to hold the PCB and the one or more connector receptacles in fixed positions. The header body seals an interface defined between the header and the battery.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 shows a proximal end portion of a conventional implantable lead that is known in the art.

[0016] Figure 2 is a cross-sectional side view of the proximal end portion of the lead positioned within a connector receptacle of a conventional IPG.

[0017] Figure 3 shows an isometric view of a conventional IPG that includes a header coupled to a can.15899WO01 (013-0623PCT1 ) 5 PATENT

[0018] Figure 4 is a block diagram of an IPG according to one or more examples of the inventive subject matter.

[0019] Figure 5 illustrates a front side of the IPG according to an example.

[0020] Figure 6 illustrates a back side of the IPG shown in Figure 5.

[0021] Figure 7 illustrates an exploded view of the IPG shown in Figures 5 and 6.

[0022] Figure 8 illustrates a back view of an electrical assembly of the IPG shown in Figures 5 through 7.

[0023] Figure 9 is an exploded view of the electrical assembly shown in Figure 8.

[0024] Figure 10 is a flow chart of a method of manufacturing an IPG according to an example.

[0025] Figure 11 illustrates a block diagram of an exemplary implantable medical device (IMD) that may represent the IPG in accordance with examples herein.DETAILED DESCRIPTION

[0026] It will be readily understood that the components of the examples as generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations in addition to the examples described herein. Thus, the following more detailed description of the examples, as represented in the figures, is not intended to limit the scope of the examples, as claimed, but is merely representative of examples.

[0027] Reference throughout this specification to “one example” or “an example” (or the like) means that a particular feature, structure, or characteristic15899WO01 (013-0623PCT1 ) 6 PATENTdescribed in connection with the example is included in at least one example. Thus, appearances of the phrases “in one example” or “in an example” or the like in various places throughout this specification are not necessarily all referring to the same example.

[0028] Furthermore, the described features, structures, or characteristics may be combined in any suitable manner in one or more examples. In the following description, numerous specific details are provided to give a thorough understanding of examples. One skilled in the relevant art will recognize, however, that the various examples can be practiced without one or more of the specific details, or with other methods, components, materials, etc. In other instances, well- known structures, materials, or operations are not shown or described in detail to avoid obfuscation. The following description is intended only by way of example and simply illustrates certain examples.

[0029] The methods described herein may employ structures or aspects of various examples (e.g., systems and / or methods) discussed herein. In various examples, certain operations may be omitted or added, certain operations may be combined, certain operations may be performed simultaneously, certain operations may be performed concurrently, certain operations may be split into multiple operations, certain operations may be performed in a different order, or certain operations or series of operations may be re-performed in an iterative fashion. It should be noted that other methods may be used, in accordance with an example herein. Further, wherein indicated, the methods may be fully or partially implemented by one or more processors of one or more devices or systems. While the operations of some methods may be described as performed by the processor(s) of one device, additionally, some or all of such operations may be performed by the processor(s) of another device described herein.

[0030] Examples may be implemented in connection with one or more implantable medical devices (IMDs). Non-limiting examples of IMDs include neurostimulator devices, implantable leadless monitoring and / or therapy devices,15899WO01 (013-0623PCT1 ) 7 PATENTcatheters, and / or alternative implantable medical devices. For example, the IMD may represent a cardiac monitoring device, pacemaker, cardioverter, cardiac rhythm management device, defibrillator, leadless pacemaker, and the like. For example, the IMD may include one or more structural and / or functional aspects of the device(s) described in U.S. Patent 9,333,351 “Neurostimulation Method And System To Treat Apnea” and U.S. Patent 9,044,610 “System And Methods For Providing A Distributed Virtual Stimulation Cathode For Use With An Implantable Neurostimulation System”, which are hereby incorporated by reference.

[0031] Additionally, the IMDs described herein may be implantable pulse generators (IPGs). For example, the IPGs may include one or more structural and / or functional aspects of the devices described in U.S. Patent 10,722,704, titled “Implantable Medical Systems and Methods Including Pulse Generators and Leads;” U.S. Patent 11 ,691 ,019, titled “Quadripolar Header Connector Support for Pre-molded Header of Implantable Pulse Generator;” and U.S. Patent 11 ,534,606, titled “Implantable Pulse Generator Headers Including Conductors Having Offset Segments,” which are hereby incorporated by reference in their entireties. Further, one or more combinations of IMDs (e.g., IPGs) may be utilized from the above incorporated patents and applications in accordance with examples herein.

[0032] All references cited herein, including publications, patent applications, and patents, are hereby incorporated by reference to the same extent as if each reference were individually and specifically indicated to be incorporated by reference and were set forth in its entirety herein.Terms

[0033] The term “hermetic,” as used herein, shall refer to a sealed interface at least with respect to entry or escape of air and / or bodily fluids.

[0034] The terms “processor,” “a processor”, “one or more processors” and “the processor” shall mean one or more processors. The one or more processors may be implemented by one, or by a combination of more than one implantable15899WO01 (013-0623PCT1 ) 8 PATENTmedical device, a wearable device, a local device, a remote device, a server computing device, a network of server computing devices and the like. The one or more processors may be implemented at a common location or at distributed locations. The one or more processors may implement the various operations described herein in a serial or parallel manner, in a shared-resource configuration and the like.

[0035] Examples set forth herein describe an implantable electronic medical device (IMD), such as an implantable pulse generator (IPG) or neurostimulator, which may be used, for example, to administer electrotherapy or other neurostimulation to patient tissue. The electrotherapy or neurostimulation may be provided to the patient tissue via one or more electrodes. In some examples, the electrode(s) may be part of one or more removable implantable leads or one or more permanently connected leads. In another example, the IMD may be a leadless device, and the electrode(s) may be an integral part of the header and / or the battery housing. The IPG includes a battery and a header (e.g., header device). The header is mounted to the battery. The header is a section of the IPG. For example, the header defines a first section of the IPG, and the battery defines a second section of the IPG. The battery includes a battery housing and power conductors. The power conductors extend from a first side of the battery housing. The header is mounted to the first side of the battery housing. The header includes a header body. The header body encases an electrical assembly. The electrical assembly may be part of the header, such that the header body and the electrical assembly define the header. The electrical assembly includes one or more connector receptacles and an electronics module. The connector receptacle(s) are configured to receive and electrically connect to one or more implantable leads inserted through corresponding bore(s) in the header body. The electronics module is electrically connected to the connector receptacle(s). The electronics module is electrically connected to the battery via the power conductors. The electronics module includes circuitry for generating electrical stimulation that is conveyed via the connector receptacle(s) and the implantable lead(s) to the patient15899WO01 (013-0623PCT1 ) 9 PATENTtissue. Similarly, but in reverse, electrical signals originating in patient tissue can travel via the lead(s) to the IPG to be sensed at the electronics module of the IPG.

[0036] Figure 1 shows a proximal end portion or section 11 of a conventional implantable lead 10 that is known in the art. The lead 10 is generally representative of any type of implantable lead whether in the cardiac, pain management or other medical treatment space. The lead 10 may be a cardiac lead designed to penetrate the cardiac tissue of the heart. In an example, the lead 10 may be positioned and advanced to penetrate the endocardium in contact with His bundle and / or the left bundle branch. The lead 10 may enter the vascular system through one of several possible vascular access sites. For example, the lead 10 may extend through the superior vena cava to the right atrium RA. The diameter of the lead 10 may be sufficiently small to facilitate the lead's implantation into small veins such as those found in the coronary sinus region of the heart and to allow implantation of a plurality of leads into a single vessel for multi-site or multi-chamber pacing. In an example, the lead 10 may be a transvenous, quadripolar, or International Standard (IS)-4 type pacing lead that includes four electrodes. The proximal end portion or section 11 of the lead 10 may be plugged into the IPG that is formed according to the examples described herein. In other examples, leads having more or less than four electrodes may be plugged into the IPG described herein.

[0037] The proximal end portion or section 11 of the conventional lead 10 shown in Figure 1 includes three spaced-apart electrical ring terminals 14A, 14B, and 14C and a tip terminal 12. The ring terminal 14A may correspond to a ventricular pace sense ring connection, the ring terminal 14B may correspond to a right ventricle or RV coil connection, and the ring terminal 14C may correspond to a superior vena cava or superior vena cava (SVC) coil connection. The tip terminal 12 may correspond to a ventricular pace sense tip electrode connection. The tip terminal 12 may be electrically connected to a tip electrode at a distal end of the lead 10 via a first inner conductor coil within a tubular housing of the lead 10. The ring terminals 14A-14C may be electrically connected to three different ring15899WO01 (013-0623PCT1 ) 10 PATENTelectrodes at or near the distal end of the lead 10 via corresponding conductor coils contained within the tubular housing. The proximal end portion or section 11 may conform to the IS-4 / defibrillation (DF)-4 standard.

[0038] Figure 2 is a cross-sectional side view of the proximal end portion or section 11 of the lead 10 positioned within a conventional connector receptacle or assembly 13 of a conventional IPG. The connector receptacle 13 may conform to the IS-4 / DF-4 standard. The connector receptacle 13 may be surrounded by a header body material of the IPG. The ring terminals 14A, 14B, 14C of the lead 10 may be engaged by different corresponding electrical contacts 16 of the connector receptacle 13. The electrical contacts 16 may be conductive garter spring contacts or other resilient electrical contact elements. The tip terminal 12 of the lead 10 may be engaged by a conductive set screw 17.

[0039] The connector receptacle 13 includes spaced-apart seal rings 18. The seal rings 18 may alternate with the electrical contacts 16 along a length of the connector receptacle 13. The seal rings 18 may electrically insulate the electrical contacts 16 from one another. The seal rings 18 may abut and seal against the outer circumferential surface of the lead 10, thereby preventing bodily fluids from reaching the electrical terminals and contacts when the lead 10 is plugged into the connector receptacle or assembly 13 through a bore 19. When the lead 10 is fully loaded into the bore 19 of the connector receptacle 13, the lead 10 is electrically connected to the IPG (e.g., cardiac pacemaker, ICD, or other implantable tissue stimulation and / or sensing device such as those used in pain management, etc.).

[0040] Figure 3 shows an isometric view of a conventional IPG 20 that includes a header 22 coupled to a can 24. The header 22 includes a pair of connector receptacle 13. The can 24 of the IPG 20 is hermetically sealed. The can 24 encloses the electronic components of the IPG 20. The header 22 is mounted along a top edge 30 of the can 24. The header 22 encloses connector components for electrically and mechanically connecting to one or more of the leads 10. For15899WO01 (013-0623PCT1 ) 11 PATENTexample, the header 22 includes a header body 26 that encases the connector receptacles 13 and associated conductive components. As shown in Figure 3, the header 22 has two bores 32, 34 for receiving the proximal end portions or sections 11 of two leads 10 therein. The bores 32, 34 are coaxial with, and fluidly connected to, the connector receptacles 13. In another example, an IPG that uses a high voltage DF-4 connector may only have a single bore 32 and a single connector receptacle 28.

[0041] The conventional IPG 20 has feedthrough pins 43 that extend across the interface between the can 24 and the header 22. The can 24 is hermetically sealed, so the feedthrough pins 43 extend into the can 24 in a manner that maintains the hermetic seal of the can 24. The feedthrough pins 43 may be electrically conductive elements, such as posts or wires. The header 22 may include ribbon conductors 40 that electrically connect to individual corresponding contacts 16 of the connector receptacles 13. A first end of the ribbon conductors 40 may be welded to the contacts 16. A second end of the ribbon conductors 40 may be electrically connected to the feedthrough pins 43. The ribbon conductors 40 and feedthrough pins 43 define electrical signal pathways between the connector receptacles 13 and the electronics within the can 24.

[0042] The conventional IPG 20 may include the can 24, a battery, an electronics module, a feedthrough assembly, connector receptacles, an antenna, and the header body 26. The feedthrough assembly may include the feedthrough pins 43. The battery and the electronics module are contained within the can 24. The feedthrough assembly hermetically seals the top edge 30 of the can 24. The connector receptacles, the antenna, and the header body 26 are components of the header 22. The header body 26 encases the antenna and the connector receptacles. The header 22 mounts to the feedthrough assembly, so that the feedthrough assembly is at the interface between the header 22 and the can 24. The ribbon conductors 40 electrically connect the connector receptacles 13 to the feedthrough pins 43. The battery includes power conductors that extend from the15899WO01 (013-0623PCT1 ) 12 PATENTbattery housing and electrically connect to the electronics module. The battery housing may be hermetically sealed to protect one or more battery cells within the battery housing.

[0043] To assemble the conventional IPG 20, the battery and the electronics module are electrically connected and installed within the can 24. Then, the feedthrough assembly is mounted onto the can 24 to seal the top edge 30, enclosing the battery and the electronics module. The antenna and the contact receptacles may be mounted to the feedthrough assembly along the top side of the feedthrough assembly facing away from the can 24. The header body 26 may be applied to surround (e.g., encase) the antenna and the contact receptacles. The header body 26 may be applied on the top side of the feedthrough assembly.

[0044] Figure 4 is a block diagram of an IPG 100 according to one or more examples of inventive subject matter described herein. The IPG 100 includes a header 102 and a battery 104. The header 102 is mounted to the battery 104. The header 102 houses the electronics and connectors of the IPG 100. The electronics and connectors define an electrical assembly 106. The electrical assembly 106 is encased in a header body 108. For example, the electrical assembly 106 includes one or more connector receptacles 110 and an electronics module 112.

[0045] Unlike the conventional IPG 20, the electronics module 112 and the connector receptacle(s) 110 of the IPG 100 are within the same component, the header 102. In an example, the connector receptacle(s) 110 is mounted to the electronics module 112. The header body 108 may surround the electronics module 112 and the connector receptacle(s) 110 to form the header 102. Furthermore, the header 102 is mounted to the battery 104 of the IPG 100, not to a discrete can 24. For example, the battery 104 is not contained within another housing. The battery housing itself may define a portion of the exterior of the IPG 100. The header 102 may be mounted to a first side of the battery 104 at an interface 114. In an example, the header body 108 may cover the interface 114. The header body 108 may surround and contact at least a portion of an exterior15899WO01 (013-0623PCT1 ) 13 PATENTsurface of the battery 104, which may support coupling of the header 102 to the battery 104, forming the IPG 100.

[0046] The IPG 100 in Figure 4 omits several components of the conventional IPG 20. For example, the IPG 100 has no can 24 surrounding the battery 104. The IPG 100 also has no feedthrough assembly 54. The battery 104 already has a hermetically sealed battery housing, so no feedthrough assembly is needed to seal a housing. Only a few elements may cross the interface 114 between the battery 104 and the header 102. Example elements include power conductors of the battery 104 to supply electrical power to the electronics module 112 and grounding conductors that electrically connect the electronics module 112 to the battery housing.

[0047] Figure 5 illustrates a front side of the IPG 100 according to an example. Figure 6 illustrates a back side of the IPG 100 shown in Figure 5. The header 102 is mounted to a first side 120 of the battery 104. The header 102 includes the electrical assembly 106 and the header body 108. The header body 108 surrounds the electrical assembly 106. The header body 108 is shown as transparent in Figures 5 and 6 so the electrical assembly 106 within the header body 108 is visible. The electrical assembly 106 is encased within the header body 108. For example, the electrical assembly 106 may be completely covered by the material of the header body 108. The header body 108 may form a hermetically sealed chamber that enclosed the electrical assembly 106 (e.g., the electronics module 112). The electrical assembly 106 may only be exposed to the external environment outside of the header body 108 through openings in the header body 108. The openings may include bores 122 for receiving implantable leads, such as the lead 10 shown in Figures 1 and 2. The header 102 may include apertures 124 for receiving set screws 126 into at least one connector block 128 to releasable secure the leads into the IPG 100. For example, after a lead is inserted into the IPG 100 through the bore 122, the set screw 126 may be tightened to secure a tip terminal of the lead, such as the tip terminal 12 shown in Figure 2.15899WO01 (013-0623PCT1 ) 14 PATENT

[0048] The battery 104 includes a battery housing 130 and power conductors 132 (shown in Figure 7) that extend from the first side 120 of the battery housing 130. The battery housing 130 is hermetically sealed. The battery housing 130 encapsulates one or more battery cells. The battery 104 powers operation of the IPG 100. For example, the battery 104 may provide electrical energy (e.g., power) to the electrical assembly 106 in the header 102 that allows the electrical assembly 106 to generate electrical stimulation that is conveyed via the lead(s) to patient tissue. The electrical stimulation may be in the form of pacing pulses, defibrillation shocks, and / or the like. The battery 104 may also power other operations of the IPG 100, such as sensing electrical signals from the patient tissue, communicating messages to external devices, and / or the like. The power conductors 132 may be pins that protrude from the housing 130 to convey the electrical power to the header 102 across the interface 114.

[0049] As shown in Figures 5 and 6, at least a portion of the battery housing 130 defines an exterior surface 134 of the IPG 100. For example, a portion of the outer surface of the battery housing 130 is exposed to the external environment. The battery housing 130 may be composed of a material that is safe for exposure to bodily fluids of the patient. For example, the battery housing 130 may be composed of a biocompatible metal, such as titanium. In an example, the battery housing 130 does not include any electronics. For example, the battery housing 130 does not include processors or a memory.

[0050] The header body 108 may at least partially cover the first side 120 of the battery 104. For example, the header body 108 may be applied on the first side 120 in a flowable state, so that the material of the header body 108 conforms (e.g., adopts) the shape and contour of the first side 120. The header body 108 may seal the interface 114 between the header 102 and the battery 104. In an example, the header body 108 includes an epoxy material. In an example, the header body 108 may form another portion of the exterior surface 134 of the IPG 100, so the epoxy material that is selected is biocompatible. The header body 108 may include a15899WO01 (013-0623PCT1 ) 15 PATENTdifferent polymer material in another example. The header body 108 may be formed in-situ on the battery 104. For example, the material of the header body 108 may be flowed over the electrical assembly 106 and the first side 120 of the battery 104 when in a flowable state, and the material may subsequently harden in place to form the header body 108. The header body 108 may adhere to the first side 120. In another example, the header body 108 may be discretely formed and then loaded onto and coupled to the battery 104 after producing the header body 108. In an example, the header body 108 may surround and engage a portion of the battery housing 130 proximate to the first side 120. For example, the header body 108 may extend beyond the interface 114 and may grip at least one side wall 140 of the battery housing 130. The side wall(s) 140 extends from the first side 120. In an example, the header body 108 may cover a portion of the side wall(s) 140 within an overlap region 142 shown in Figure 5. In another example, a thin layer of the material of the header body 108, or another polymer material, may surround the entirety of the battery housing 130. Notably absent from the IPG 100 are the can 24 and the feedthrough assembly 54 from the conventional IPG 20 shown in Figure 3. The IPG 100 does not include a supplemental metal housing (in addition to the battery housing 130) and does not have a feedthrough assembly at the interface 114.

[0051] Figure ? illustrates an exploded view of the IPG 100 shown in Figures 5 and 6. In the exploded view, the electrical assembly 106 is located between the header body 108 and the battery 104. The exploded view is shown for descriptive purposes. The exploded view may not accurately represent the manufacturing process to produce the IPG 100. For example, the header body 108 according to an example may be formed in-situ around the electrical assembly 106 and the first side 120 of the battery 104, rather than a discrete component as indicated in Figure 7.

[0052] In an example, the electrical assembly 106 includes one or more connector receptacles 150 (shown in Figure 9) and an electronics module 152.15899WO01 (013-0623PCT1 ) 16 PATENTThe electronics module 152 includes circuitry that controls operation of the IPG 100. For example, the circuitry may generate electrical stimulation that is conveyed via the connector receptacle(s) 150 and the implantable lead(s) to patient tissue. The circuitry can include one or more processors and / or a memory (e.g., data storage device). In an example, the electronics module 152 includes a printed circuit board (PCB) 154. By being located in the header body 108, the header 102 may include the one or more processors and / or the memory, which form part of the circuitry.

[0053] The components of the electrical assembly 106 may be coupled together to form one unit. The electrical assembly 106 may be mounted to the battery 104 at the first side 120. For example, the electrical assembly 106 may be mechanically coupled to the battery housing 130 at the first side 120 via fasteners 156. The fasteners 156 may extend through brackets or flanges of the electrical assembly 106 and penetrate holes in the first side 120 of the housing 130. The fasteners 156 may be screws that engage helical threads in the holes of the housing 130. Optionally, an adhesive may be used to adhere the bottom surface of the electrical assembly 106 to the first side 120 of the battery housing 130. The adhesive may be used with or without the fasteners 156.

[0054] In an example, the electrical assembly 106 may be relatively flat and planar. The electrical assembly 106 may be mounted to the battery 104 in an orientation that is approximately parallel to, and coplanar with, an orientation of the battery 104. The electrical assembly 106 may be oriented to extend from the battery 104 in approximately the same plane as occupied by the battery 104. The PCB 154 may be planar and oriented so that the plane of the PCB 154 is approximately perpendicular to the first side 120 of the battery housing 130. The term “approximately” encompasses angles between the identified components that are within a threshold limit of 90 degrees or 180 degrees. The threshold limit may be + / - 5 degrees, 10 degrees, or the like.15899WO01 (013-0623PCT1 ) 17 PATENT

[0055] Figure 7 shows two power conductors 132 that extend from the first side 120 of the battery housing 130. One of the power conductors 132 may represent a positive contact connected to a positive battery terminal (within the housing 130), and the other power conductor 132 may represent a negative contact connected to a negative battery terminal. In one example, the power conductors 132 may be the only components that protrude from the battery housing 130. In the illustrated example, however, the battery 104 includes grounding conductors 160 that also project from the first side 120. Four grounding conductors 160 are shown in Figure 7, but the battery 104 may have fewer or greater than four grounding conductors 160 in other examples. The grounding conductors 160 are electrically connected to the battery housing 130. For example, the grounding conductors 160 may be metal pins that are electrically connected to the metallic housing 130. In an example, the grounding conductors 160 may be welded directly to the battery housing 130. When the electrical assembly 106 is mounted to the battery 104, the grounding conductors 160 electrically connect to the electronics module 152. For example, the electronics module 152 may include grounding sockets 162 that are mounted on the PCB 154 at specific locations to receive the corresponding grounding conductors 160 therein as the electrical assembly 106 is moved towards the first side 120 of the battery 104. The grounding conductors 160 electrically connect to the grounding sockets 162. The electronics module 152 may use the grounding conductors 160 to selectively employ the battery housing 130 as an electrode. In an example in which the option of using the battery housing 130 as an electrode is not desired, the IPG 100 may omit the grounding conductors 160. The battery housing 130 may also shunt undesired external electrical signals from coming into the electrical assembly 106 via the leads.

[0056] Figure 8 illustrates a back view of the electrical assembly 106 of the IPG 100 shown in Figures 5 through 7. Figure 7 shows a front view of the electrical assembly 106. Figure 9 is an exploded view of the electrical assembly 106 shown in Figure 8. The following description refers to Figures 7 through 9.15899WO01 (013-0623PCT1 ) 18 PATENT

[0057] The IPG 100 in the illustrated example has two connector receptacles 150 configured to receive and electrically connect to implantable leads. The connector receptacles 150 are aligned with the bores 122 in the header body 108. For example, as the proximal end portion or section 11 of the lead 10 is inserted through the bore 122, the proximal end portion or section 11 enters the corresponding connector receptacle 150. The connector receptacles 150 are electrically connected to the electronics module 152. The connector receptacles 150 include annular electrical contacts 164 alternating with insulating rings 166 in a row. The electrical contacts 164 may be electrically connected to circuitry on the PCB 154 via contact pins 167. The contact pins 167 may be welded, soldered, inserted, or otherwise secured to the PCB 154. The contact pins 167 provide conductive pathways between the connector receptacles 150 and the electronics module 152. The connector receptacles 150 may be disposed proximate to the PCB 154 of the electronics module 152. For example, the connector receptacles 150 may be mounted to the PCB 154.

[0058] The PCB 154 may include power receptacles configured to mechanically couple to and electrically connect to the power conductors 132 of the battery 104. The power receptacles in an example are power sockets 168. The power sockets 168 are positioned to align with the power conductors 132 of the battery 104. As the electrical assembly 106 is moved towards the first side 120 of the battery 104 during assembly, the power conductors 132 may be received into different corresponding power sockets 168. The connection between the power conductors 132 and the power sockets 168 electrically connects the battery 104 to the electronics module 152 (across the interface 114 shown in Figure 5).

[0059] In an example, the electrical assembly 106 includes a support frame 170 that holds the electronics module 152 and the one or more connector receptacles 150 in fixed positions. The support frame 170 may be a molded plastic part. The support frame 170 may clip onto the PCB 154 via latch members 172. The support frame 170 may hold the connector receptacles 150. For example, the15899WO01 (013-0623PCT1 ) 19 PATENTsupport frame 170 may include two barrel-shaped features 174 that define cavities sized and shaped to accommodate the connector receptacles 150 therein. Once the connector receptacles 150 are loaded into the corresponding cavities of the barrels 174, the connector block 128 may be coupled to the support frame 170 at the open ends of the barrels 174 to lock the connector receptacles 150 within the cavities.

[0060] In an example, the support frame 170 mounts to the first side 120 of the battery housing 130 to secure the electrical assembly 106 to the battery 104. For example, the support frame 170 may include at least one mounting bracket 178 along a bottom end of the support frame 170. The mounting bracket 178 may abut the first side 120 and may secure to the first side 120. For example, the mounting bracket 178 may have an aperture 180 that receives a portion of the fastener 156 (shown in Figure 7) therethrough. The fastener 156 may threadably couple to the battery housing 130, which secures the support frame 170 to the first side 120.

[0061] In an example, the electrical assembly 106 also includes at least one antenna 182. The antenna 182 in Figures 8 and 9 has a generally linear shape along a majority of the length of the antenna 182, but the antenna 182 may have a more rounded, coiled, and / or three-dimensional shape in other examples. The antenna 182 may allow the electronics module 152 to wirelessly communicate with external devices. A fixed end of the antenna 182 may be secured to circuitry on the PCB 154. In an example, the support frame 170 holds the free end of the antenna 182 in place relative to the PCB 154 and the connector receptacles 150. For example, the support frame 170 may include one or more protrusions 184 that project from a wall 186 of the support frame 170. The protrusions 184 may be retention fingers that allow the antenna 182 to clip into the support frame 170. For example, the protrusions 184 may slightly deflect as the antenna 182 is loaded into and / or taken out of the support frame 170.15899WO01 (013-0623PCT1 ) 20 PATENT

[0062] Figure 10 is a flow chart of a method 200 of manufacturing an IPG according to an example. The method 200 may be used to manufacture the IPG 100 shown in Figures 4 through 9. In different examples, the method may include different steps not shown in Figure 10, may omit one or more of the steps shown in Figure 10, and / or may have a different order of the steps than shown in Figure 10.

[0063] At step 202, an electrical assembly 106 is assembled. The electrical assembly 106 includes at least one connector receptacle 150 and an electronics module 152 that is electrically connected to the connector receptacle(s) 150. The connector receptacle(s) 150 are designed to receive and electrically connect to implantable leads 10. The electronics module 152 includes circuitry for generating electrical stimulation that is conveyed via the connector receptacle(s) 150 and the implantable lead(s) 10 to patient tissue. In an example, the electronics module 152 includes a printed circuit board (PCB) 154. Assembling the electrical assembly 106 may include mounting the connector receptacle(s) 150 on the PCB 154. For example, assembling the electrical assembly 106 may include welding contact pins 167 to annular electrical contacts 164 of the connector receptacle(s) 150 and mounting the contact pins 167 to circuitry on the PCB 154.

[0064] In an example, the electrical assembly 106 includes a support frame 170. Assembling the electrical assembly 106 may include coupling the electronics module 152 and the connector receptacle(s) 150 to the support frame 170. The assembly step may also include electrically connecting an antenna 182 to the electronics module 152 (e.g., the PCB 154) and coupling the antenna 182 to the support frame 170 via one or more protrusions 184.

[0065] At step 204, the electrical assembly 106 is mounted to a first side 120 of a battery housing 130 of a battery 104. The mounting is performed so that the electronics module 152 is electrically connected to power conductors 132 of the battery 104. The power conductors 132 extend from the first side 120 of the battery housing 130. In an example, the electrical assembly 106 may be moved15899WO01 (013-0623PCT1 ) 21 PATENTtowards the battery 104 so that power sockets 168 connected to the PCB 154 align with and receive the corresponding power conductors 132. The electrical assembly 106 may be secured to the first side 120 via an adhesive, one or more fasteners, and / or the like. In an example, the support frame 170 includes at least one mounting bracket 178. The electrical assembly 106 may be mounted to the battery housing 130 by installing a fastener 156 through each mounting bracket 178 into the first side 120 of the battery housing 130.

[0066] At step 206, a header body 108 is formed to encase the electrical assembly 106. The header body 108 combined with the electrical assembly 106 may define the header 102 that is secured to the battery 104. In an example, the header body 108 is formed in-situ by flowing a material of the header body 108, when in a flowable state, to surround and conform to a contour of the electrical assembly 106. The material of the header body 108 may also cover and conform to the contour of the first side 120 of the battery housing 130. The material optionally may cover and conform to the contour of a portion of one or more sidewalls 140 of the battery housing 130 extending from the first side 120. This forming step may involve placing the electrical assembly 106 and at least part of the battery 104 into a mold that is shaped to define the header body 108. The material of the header body 108 may be flowed into the mold. Upon hardening, the header body 108 may solidify and can be removed from the mold. The header body 108 may be formed to seal an interface 114 defined between the header 102 and the battery 104. Optionally, the header body 108 may surround and grip a portion of the battery housing 130 proximate to the first side 120 to enhance the sealing effect and / or the coupling of the header 102 to the battery 104.

[0067] The IPG 100 described herein has several beneficial technical effects over conventional IPGs. For example, the IPG 100 has fewer components than the conventional IPG 20, which may represent a substantial cost savings for production. The cost savings may be attributable to reduced parts cost and fewer manufacturing steps during assembly. For example, the IPG 20 does not have a15899WO01 (013-0623PCT1 ) 22 PATENTcan (e.g., housing or case) that is separate from the battery 104. The battery 104 is not inserted into a discrete can with the electronics module. By avoiding the discrete can, the manufacturing is simplified because there is no can to hermetically seal. The IPG 100 also does not include a feedthrough assembly that is used to seal the can. The IPG 100 beneficially utilizes the inherent hermetically sealed housing 130 of the battery 104 as the can component.

[0068] In general, the IPG 100 described herein has an efficient design with a reduced complexity relative to conventional IPGs. For example, the IPG 100 may have fewer conductors and / or connectors exiting the hermetically sealed battery housing 130 than conventional IPGs. All of the electronics and lead connector receptacles may be located proximate to each other within the header 102. The electrical circuitry and other electrical components may be conveniently packaged together by mounting on the same PCB 154. For example, the lead connector receptacles 150, the antenna 182, communication circuitry, processing circuitry, data storage devices, battery charging coils, and / or the like may be disposed within the header 102 and electrically connected to the PCB 154. By contrast, in conventional IPGs the electronics module is in the hermetically sealed can, and several components are required to convey electrical signals between the electronics module and the lead connector receptacles. These bridging components include the feedthrough assembly 54 with the feedthrough pins 43, the ribbon conductors 40, and the like. This complicated arrangement typically requires several welding operations to construct the electrical signal pathways.

[0069] The efficient design of the IPG 100 may enable the IPG 100 to have a reduced size (e.g., form factor) relative to other IPGs. For example, the IPG 100 may have a smaller overall volume. The design may allow the IPG 100 to have more rounded comers (e.g., a more rounded overall shape) than other IPGs.

[0070] Another technical effect is that the IPG 100 may have improved performance by reducing electrical interference. For example, the IPG 100 lacks a metal can surrounding the electronics module 152. As a result, the electronics15899WO01 (013-0623PCT1 ) 23 PATENTmodule 152 is not affected by electrical interference and / or shielding effects that would be caused by a metal can surrounding the electronics module 152. The electronics module 152 may not experience the performance attenuation that would be experienced by an electronics module 152 that is housed within a metal can.

[0071] Figure 11 illustrates a block diagram of an exemplary IMD 600 that may represent the IPG 100 in accordance with examples herein. The IMD 600 may treat both fast and slow arrhythmias with stimulation therapy, including cardioversion, pacing stimulation, an implantable cardioverter defibrillator, suspend tachycardia detection, tachyarrhythmia therapy, and / or the like.

[0072] The IMD 600 has a housing 661 to hold the electronic / computing components. The housing 661 may include the header body 108 and the battery housing 130 of the IPG 100. The battery housing 130 may be programmably selected to act as the return electrode for certain stimulus modes. The housing 661 further includes a connector receptacle (e.g., the receptacle 150 shown in Figure 9) with a plurality of terminals 601 , 602, 604, 606, 608, and 610. The terminals may be connected to one or more leads (e.g., lead 10) that are located in various locations within and about the heart. Each lead may have one or more electrodes. The type and location of each electrode may vary. For example, the electrodes may include various combinations of ring, tip, coil, shocking electrodes, and the like.

[0073] The IMD 600 includes a programmable microcontroller 620 that controls various operations of the IMD 600, including cardiac monitoring and stimulation therapy. The microcontroller 620 may be part of the electronics module 152 of the IPG 100. Although the IMD 600 is described for cardiac applications, the IPG 100 is not limited to cardiac applications. For example, the IPG 100 described herein can be a neurostimulator that provides stimulation therapy to patient tissue remote from the heart, such as to neural tissue. The microcontroller 620 includes a microprocessor (or equivalent control circuitry), one or more15899WO01 (013-0623PCT1 ) 24 PATENTprocessors, random access memory (RAM) and / or read-only memory (ROM) memory, logic and timing circuitry, state machine circuitry, and input and output (I / O) circuitry. The IMD 600 further includes a pulse generator 622 that generates stimulation pulses for connecting the desired electrodes to the appropriate I / O circuits, thereby facilitating electrode programmability. The microcontroller 620 may generate a control signal 628 to control an electrode configuration switch 626.

[0074] Optionally, the IMD 600 may include multiple pulse generators, similar to the pulse generator 622, where each pulse generator is coupled to one or more leads / electrodes and controlled by the microcontroller 620 to deliver select stimulus pulse(s) to the corresponding one or more electrodes. The IMD 600 includes sensing circuit 644 selectively coupled to one or more electrodes that perform sensing operations, through the switch 626 to detect the presence of cardiac activity in the chamber of the heart. The output of the sensing circuit 644 is connected to the microcontroller 620 which, in turn, triggers, or inhibits the pulse generator 622 in response to the absence or presence of cardiac activity. The sensing circuit 644 receives a control signal 646 from the microcontroller 620 for purposes of controlling the gain, threshold, polarization charge removal circuitry (not shown), and the timing of any blocking circuitry (not shown) coupled to the inputs of the sensing circuit 624.

[0075] In the example of Figure 11 , the sensing circuit 644 is illustrated. Optionally, the IMD 600 may include multiple sensing circuits 644, where each sensing circuit is coupled to one or more leads / electrodes and controlled by the microcontroller 620 to sense electrical activity detected at the corresponding one or more electrodes. The sensing circuit 624 may operate in, for example, a unipolar sensing configuration or a bipolar sensing configuration.

[0076] The IMD 600 further includes an analog-to-digital (A / D) data acquisition system (DAS) 650 coupled to one or more electrodes via the switch 626 to sample cardiac signals across any pair of desired electrodes. The A / D converter 650 is configured to acquire intracardiac electrogram signals, convert15899WO01 (013-0623PCT1 ) 25 PATENTthe raw analog data into digital data and store the digital data for later processing and / or telemetric transmission to an external device 690 (e.g., a programmer, local transceiver, or a diagnostic system analyzer). The A / D converter 650 is controlled by a control signal 656 from the microcontroller 620.

[0077] The microcontroller 620 is operably coupled to a memory 660 by a suitable data / address bus 662. The programmable operating parameters used by the microcontroller 620 are stored in the memory 660 and used to customize the operation of the IMD 600 to suit the needs of a particular patient. The operating parameters of the IMD 600 may be non-invasively programmed into the memory 660 through a telemetry circuit 664 in telemetric communication via communication link 667 (e.g., MICS, Bluetooth low energy, and / or the like) with the external device 690.

[0078] The IMD 600 can further include one or more physiological sensors 670. Such sensors are commonly referred to as “rate-responsive” sensors because they are typically used to adjust pacing stimulation rates according to the exercise state of the patient. However, the physiological sensor 670 may further be used to detect changes in cardiac output, changes in the physiological condition of the heart, or diurnal changes in activity (e.g., detecting sleep and wake states). Signals generated by the physiological sensors 670 are passed to the microcontroller 620 for analysis. While shown as being included within the IMD 600, the physiological sensor(s) 670 may be external to the IMD 600, yet still, be implanted within or carried by the patient. Examples of physiological sensors might include sensors that, for example, sense respiration rate, pH of blood, ventricular gradient, activity, position / posture, minute ventilation, and / or the like.

[0079] A battery 672 provides operating power to all of the components in the IMD 600. The battery 672 may be the battery 104 of the IPG 100. The battery 672 may be capable of operating at low current drains for long periods of time, and is capable of providing a high-current pulses (for capacitor charging) when the patient requires a shock pulse (e.g., in excess of 2 A, at voltages above 2 V, for15899WO01 (013-0623PCT1 ) 26 PATENTperiods of 10 seconds or more). The battery 672 may have a predictable discharge characteristic so that elective replacement time can be detected. As one example, the IMD 600 employs lithium / silver vanadium oxide batteries.

[0080] The IMD 600 further includes an impedance measuring circuit 674, which can be used for many things, including sensing respiration phase. The impedance measuring circuit 674 is coupled to the switch 626 so that any desired electrode and / or terminal may be used to measure impedance in connection with monitoring respiration phase. The IMD 600 is further equipped with a communication modem (modulator / demodulator) 640 to enable wireless communication with other devices, implanted devices and / or external devices. In one implementation, the communication modem 640 may use high frequency modulation of a signal transmitted between a pair of electrodes. As one example, the signals may be transmitted in a high frequency range of approximately 10-80 kHz, as such signals travel through the body tissue and fluids without stimulating the heart or being felt by the patient.

[0081] Optionally, the microcontroller 620 may control a shocking / therapy circuit 680 by way of a timing control 632. The shocking / therapy circuit 680 generates electrical pulses to be provided to patient tissue as therapy. The electrical pulses may be shocking pulses. The shocking / therapy circuit 680 may be controlled by the microcontroller 620 via a control signal 682. The IMD 600 may lack the shocking / therapy circuit 680 in other examples, such as when designed for neurostimulation applications.

[0082] Although not shown, the microcontroller 620 may further include other dedicated circuitry and / or firmware / software components that assist in monitoring various conditions of the patient's heart and managing pacing therapies. The microcontroller 620 may include a timing control 632, an arrhythmia detector 634, a morphology detector 636 and multi-phase therapy controller 633. The timing control 632 is used to control various timing parameters, such as stimulation pulses (e.g., pacing rate, atria-ventricular (AV) delay, atrial15899WO01 (013-0623PCT1 ) 27 PATENTinterconduction (A-A) delay, ventricular interconduction (V-V) delay, etc.) as well as to keep track of the timing of RR-intervals, refractory periods, blanking intervals, noise detection windows, evoked response windows, alert intervals, marker channel timing, and the like.

[0083] The morphology detector 636 is configured to review and analyze one or more features of the morphology of cardiac activity signals. For example, in accordance with examples herein, the morphology detector 636 may analyze the morphology of detected R waves, where such morphology is then utilized to determine whether to include or exclude one or more beats from further analysis. For example, the morphology detector 636 may be utilized to identify nonconducted ventricular events, such as ventricular fibrillation and the like.

[0084] The arrhythmia detector 634 may be configured to apply one or more arrhythmia detection algorithms for detecting arrhythmia conditions. By way of example, the arrhythmia detector 634 may apply various detection algorithms. The arrhythmia detector 634 may be configured to declare a ventricular fibrillation episode based on the cardiac events.

[0085] The therapy controller 633 may be configured to identify a multiphase therapy including a pacing therapy. The therapy controller 633 may manage delivery of burst pacing therapy at a pacing site in a coordinated manner after one or more shocks. The pacing site may be located at a target site of interest (SOI), such as a His Bundle. Optionally, other pacing sites may be located at one of the left ventricular (LV) site or a right ventricular (RV) site. The therapy controller 633 may manage delivery of the shock along a shocking vector between shocking electrodes.

[0086] Reference throughout this specification to “one example” or “an example” (or the like) means that a particular feature, structure, or characteristic described in connection with the example is included in at least one example. Thus, appearances of the phrases “in one example” or “in an example” or the like15899WO01 (013-0623PCT1 ) 28 PATENTin various places throughout this specification are not necessarily all referring to the same example.

[0087] It is to be understood that the above description is intended to be illustrative, and not restrictive. For example, the above-described examples (and / or aspects thereof) may be used in combination with each other. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the inventive subject matter without departing from its scope. While the dimensions and types of materials described herein are intended to define the parameters of the inventive subject matter, they are by no means limiting and are exemplary examples. Many other examples will be apparent to one of ordinary skill in the art upon reviewing the above description. The scope of the inventive subject matter should, therefore, be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled. In the appended claims, the terms “including” and “in which” are used as the plain- English equivalents of the respective terms “comprising” and “wherein.” Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. Further, the limitations of the following claims are not written in means-plus- function format and are not intended to be interpreted based on 35 U.S.C. § 112(f) unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function void of further structure.15899WO01 (013-0623PCT1 ) 29 PATENT

Claims

AMENDED CLAIMS received by the International Bureau on 04 May 2026 (04.05.2026)1. (Currently amended) An implantable pulse generator comprising: a battery including a battery housing, one or more battery cells within the battery housing, and power conductors provided on a first side of the battery housing, wherein at least a portion of the battery housing defines an exterior surface of the implantable pulse generator; a header mounted to the first side of the battery housing, the header including a header body, wherein the implantable pulse generator has no can surrounding the battery and does not have a feedthrough assembly at an interface between the header and the battery; one or more connector receptacles located within the header body, the one or more connector receptacles configured to electrically connect to one or more electrodes; and an electronics module located within the header body, the electronics module electrically connected to the one or more connector receptacles and electrically connected to the battery via the power conductors, wherein the electronics module includes circuitry for generating electrical stimulation that is conveyed via the one or more connector receptacles and the one or more electrodes to patient tissue.

2. (Original) The implantable pulse generator of claim 1 , wherein the electronics module, within the header body, includes a printed circuit board (PCB), and the one or more connector receptacles are mounted on the PCB.

3. (Original) The implantable pulse generator of claim 2, wherein the PCB is planar and the PCB is oriented in the header body so that a plane of the PCB is approximately perpendicular to the first side of the battery housing.

4. (Original) The implantable pulse generator of claim 1 , further comprising a support frame that holds the electronics module and the one or more connector receptacles in fixed positions.

355. (Original) The implantable pulse generator of claim 4, wherein the support frame is mounted to the first side of the battery housing.

6. (Original) The implantable pulse generator of claim 5, wherein the support frame includes at least one mounting bracket configured to secure to the battery housing via a fastener.

7. (Original) The implantable pulse generator of claim 4, further comprising an antenna located within the header body, wherein the support frame includes one or more protrusions that project from a wall of the support frame to hold the antenna.

8. (Original) The implantable pulse generator of claim 1 , wherein each of the one or more connector receptacles includes annular electrical contacts alternating with insulating rings in a row.

9. (Original) The implantable pulse generator of claim 1 , wherein the power conductors of the battery are pins that extend from the battery housing, and the electronics module includes sockets configured to receive the power conductors during assembly to electrically connect the electronics module to the battery.

10. (Currently amended) The implantable pulse generator of claim 1 , wherein the header body seals the interface defined between the header and the battery.

11. (Original) The implantable pulse generator of claim 10, wherein the header body surrounds and engages a portion of the battery housing proximate to the first side of the battery housing to secure the header to the battery.

12. (Original) The implantable pulse generator of claim 1 , further comprising one or more grounding conductors that are electrically connected to the battery housing and extend from the first side of the battery housing, wherein the one or more grounding conductors are electrically connected to the electronics module within the header body to selectively use the battery housing as an electrode.

13. (Canceled)14. (Original) The implantable pulse generator of claim 1 , wherein the battery housing includes titanium.

15. (Original) The implantable pulse generator of claim 1 , wherein the header body includes an epoxy material.

16. (Original) The implantable pulse generator of claim 1 , wherein the one or more connector receptacles are configured to receive and electrically connect to one or more implantable leads inserted through one or more corresponding bores in the header body, wherein the one or more electrodes are located on the one or more implantable leads.

17. (Currently amended) A method of manufacturing an implantable pulse generator, the method comprising: assembling an electrical assembly by electrically connecting one or more connector receptacles to an electronics module, the one or more connector receptacles configured to electrically connect to one or more electrodes, wherein the electronics module includes circuitry for generating electrical stimulation that is conveyed via the one or more connector receptacles and the one or more electrodes to patient tissue; mounting the electrical assembly to a first side of a battery housing of a battery so that the electronics module is electrically connected to power conductors of the battery, the power conductors provided on the first side of the battery housing; and forming a header body to encase the electrical assembly and define a header that is secured to the battery, wherein at least a portion of the battery housing defines an exterior surface of the implantable pulse generator, and wherein the implantable pulse generator has no can surrounding the battery and does not have a feedthrough assembly at an interface between the header and the battery.

18. (Original) The method of claim 17, wherein the electronics module includes a printed circuit board (PCB), and assembling the electrical assembly comprises mounting the one or more connector receptacles on the PCB.

19. (Original) The method of claim 17, wherein the electrical assembly includes a support frame, and assembling the electrical assembly comprises coupling the electronics module and the one or more connector receptacles to the support frame.

20. (Original) The method of claim 19, wherein the support frame includes at least one mounting bracket, and mounting the electrical assembly to the first side of the battery housing comprises installing at least one fastener through the at least one mounting bracket into the first side of the battery housing.

21. (Original) The method of claim 17, wherein forming the header body to encase the electrical assembly comprises flowing a material of the header body in a flowable state in-situ to surround and conform to a contour of the electrical assembly.

22. (Currently amended) The method of claim 17, wherein forming the header body comprises causing a material of the header body to seal the interface defined between the header and the battery and to surround and engage a portion of the battery housing proximate to the first side of the battery housing to secure the header to the battery.

23. (Currently amended) An implantable pulse generator comprising: a battery including a battery housing, one or more battery cells within the battery housing, and power conductors provided on a first side of the battery housing, wherein at least a portion of the battery housing defines an exterior surface of the implantable pulse generator; and a header mounted to the first side of the battery housing, the header including an electrical assembly encased in a header body, wherein the implantable pulse generator has no can surrounding the battery and does not have a feedthrough assembly at an interface between the header and the battery, the electrical assembly comprising: one or more connector receptacles configured to receive and electrically connect to one or more implantable leads inserted through one or more corresponding bores in the header body;an electronics module electrically connected to the battery via the power conductors, the electronics module including a printed circuit board (PCB) electrically connected to the one or more connector receptacles, wherein the electronics module includes circuitry for generating electrical stimulation that is conveyed via the one or more connector receptacles and the one or more implantable leads to patient tissue; and a support frame that couples to the PCB and the one or more connector receptacles to hold the PCB and the one or more connector receptacles in fixed positions, wherein the header body seals the interface defined between the header and the battery.39

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