CN117861076A

CN117861076A - Implantable stimulator with externalized battery

Info

Publication number: CN117861076A
Application number: CN202311305787.8A
Authority: CN
Inventors: R·V·艾耶; A·J·汤姆; P·B·扬; G·甲殷; V·R·盖达姆; A·梅赫拉; C·L·施密特
Original assignee: Medtronic Inc
Current assignee: Medtronic Inc
Priority date: 2022-10-12
Filing date: 2023-10-10
Publication date: 2024-04-12

Abstract

An exemplary medical device includes: a device housing configured to be implantable within a patient, the device housing comprising an inner surface that is in contact with a voltaic cell of the battery; and a battery located outside the device housing and including a battery housing configured to be hermetically sealed. The battery is configured to provide power to electronic components housed within the device housing, and the battery housing is configured to be attached to the device housing. The battery case includes: an inner surface in contact with the voltaic cell of the battery; and an outer surface in contact with the biocompatible electrical insulator.

Description

Implantable stimulator with externalized battery

The present application claims the benefit of U.S. provisional patent application 63/379,261 filed on 10/12 of 2022, the entire contents of which are hereby incorporated by reference.

Technical Field

The present disclosure relates to medical devices, and more particularly, to medical devices that deliver therapy to a patient.

Background

The implantable medical device is configured to deliver electrical stimulation therapy or monitor physiological signals. For example, electrical stimulation of neural tissue may provide relief from a variety of conditions, thereby improving the quality of life for many patients.

Diseases, ages, and injuries can impair the physiological function of a patient. In some cases, the physiological function is completely impaired. In other examples, physiological functions may operate adequately at some times or under some conditions, and inadequately at other times or under other conditions. In one example, bladder dysfunction such as overactive bladder, urgency, or urinary incontinence is a problem that can afflict people of all ages, sexes, and ethnicities. Various muscles, nerves, organs and ducts within the pelvic floor cooperate to collect, store and release urine. A variety of disorders can impair urinary tract performance and lead to overactive bladder, urgency or incontinence that interfere with normal physiological function. Many disorders may be associated with aging, injury, or disease.

Urinary incontinence can include urge incontinence and stress incontinence. In some examples, urge incontinence can be caused by an imbalance in the peripheral or central nervous system that controls the urinary bladder reflex. Some patients may also suffer from neurological disorders that interfere with the normal triggering and operation of the bladder, sphincter muscles, or that lead to overactive bladder or urge incontinence. In some cases, urinary incontinence can be due to abnormal sphincter function in the internal or external urinary sphincters.

Disclosure of Invention

In general, the present disclosure relates to devices, systems, and techniques for improving battery capacity for power delivery to electronics in an Implantable Medical Device (IMD), such as an implantable stimulation device. In some examples, the present disclosure relates to devices, systems, and techniques for increasing the battery capacity of an IMD without increasing the overall size and/or volume of the IMD.

Implantable medical devices (such as tibial stimulators, neurostimulators, nerve monitoring devices, etc.) may benefit from increased battery capacity without increasing the volume and/or surface area of the IMD. To increase battery capacity, the size of the battery may be increased at the expense of reducing and/or reducing non-battery components, e.g., to avoid increasing the overall size/volume of the IMD. In the examples described herein, the battery size may be increased by "externalizing" the battery to eliminate a portion of the IMD housing. For example, rather than enclosing the battery within the housing of the IMD, the battery may be externalized by attaching the battery to an exterior portion of the IMD housing. The externalized battery may be referred to as a "single-case" battery because the battery portion of the device (e.g., IMD) utilizing the battery includes a single housing and/or enclosure for the battery cells, voltaic battery cells, battery materials, and/or battery chemistries. The battery that is not externalized is a battery housed within the device housing. Such a battery will have its own battery housing or enclosure and will additionally be housed within the enclosure of the device. Such non-externalized batteries may be referred to as "double-case" batteries because the battery portion of the device (e.g., IMD) utilizing the battery includes two housings and/or enclosures, e.g., a device housing that houses the battery and a battery housing that houses the battery cells, voltaic cells, battery pack materials, and/or battery chemistries. A separate double-shell battery may be located "external" to the device and have a double shell, e.g., a battery having its own battery housing that is also housed within a housing configured to be attached to the device housing. In examples described herein, the externalized battery may be a single housing that includes a battery housing that both houses battery cells, voltaic battery cells, battery materials, and/or battery chemistries, and is configured to be attached to an external portion of a device (e.g., IMD) that utilizes the battery.

In one or more examples, the externalized battery is located outside of the IMD housing and does not include a separate housing. The battery housing, which is configured to encapsulate the battery cells, voltaic cells, battery materials, and/or battery chemistries of the externalized battery, is exposed to the same environment as the IMD housing, such as air, body tissue and/or body fluids (when implanted), device coatings, and the like. The battery housing of the externalized battery may include or be connected to terminals of the battery, and thus, the terminals of the exemplary externalized battery disclosed herein may include battery terminals that are surface exposed to the same environment (e.g., air, body tissue and/or fluids, device coatings, etc.) as the outer surface of the IMD housing, as the exemplary externalized battery disclosed herein may include a monocoque battery.

The externalized battery is distinguished from a separate double-shell battery, which may be attached to the IMD but not within the housing of the IMD. As discussed above, a separate dual-shell battery is enclosed in a separate housing separate from the IMD housing and configured to mate with or attach to the IMD housing. However, the battery still includes a battery housing that encapsulates the battery chemistry within a separate housing, e.g., the battery is double-shelled. The individual double-shell battery does not have battery terminals with surfaces exposed to the same environment (e.g., air, body tissue and/or fluids, device coatings, etc.) as the battery housing of the individual double-shell battery configured to encapsulate the battery cells, voltaic cells, battery materials, and/or battery chemistries is contained within the individual housing.

Accordingly, these techniques may provide one or more technical advantages to realize at least one practical application. For example, the disclosed systems, devices, and techniques may improve the battery capacity and lifetime of an IMD without increasing the overall size, volume, and/or surface area of the IMD. In some examples, these systems, devices, and techniques may improve recharging of an IMD and may provide improved wireless communication, for example, via at least a portion of an IMD housing and/or battery housing that includes Radio Frequency (RF) transparent and/or non-shielding materials.

In one example, the present disclosure describes a medical device comprising: a device housing configured to be implantable within a patient, the device housing comprising an outer surface in contact with a biocompatible electrical insulator; an electronic component housed within the device housing; and a battery located outside the device housing and comprising a battery housing configured to be hermetically sealed, wherein the battery is configured to provide power to the electronic component housed within the device housing, wherein the battery housing is configured to be attached to the device housing, wherein the battery housing comprises: an inner surface in contact with the voltaic cell of the battery; and an outer surface in contact with the biocompatible electrical insulator.

In another example, the present disclosure describes a medical device comprising: stimulation circuitry configured to generate an electrical stimulation signal; and a device housing configured to be implantable within a patient; wherein the device housing comprises: a first portion housing the stimulation circuitry within a first volume; and a second portion that houses a battery within a second volume, wherein the second portion forms a hermetic seal of the second volume, and wherein the battery is configured to provide power to the stimulation circuitry.

In another example, the present disclosure describes a method of manufacturing a medical device, the method comprising: hermetically sealing the voltaic cell within a battery enclosure configured to be implantable within a patient; and externally attaching the battery housing to a device housing configured to be implantable in a patient, wherein the battery housing comprises: an inner surface in contact with the voltaic cell of the battery; and an outer surface exposed to substantially the same environment as the outer surface of the device housing.

The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims.

The above summary is not intended to describe each illustrated example or every implementation of the present disclosure.

Drawings

Fig. 1 is a schematic diagram illustrating an exemplary medical device.

Fig. 2 is a schematic diagram illustrating an exemplary medical device.

Fig. 3 is a schematic diagram illustrating an exemplary medical device.

Fig. 4 is a schematic diagram illustrating an exemplary medical device.

Fig. 5 is a schematic diagram illustrating an exemplary medical device.

Fig. 6 is a conceptual diagram illustrating a leg in which a medical device is implanted near a tibial nerve.

Fig. 7 is a conceptual diagram illustrating an exemplary system for managing delivery of neural stimulation to a patient to manage bladder dysfunction, such as overactive bladder, urgency, or urinary incontinence.

Fig. 8 is a block diagram illustrating an exemplary configuration of an Implantable Medical Device (IMD).

Fig. 9 is a block diagram showing an exemplary configuration of an external programmer.

Fig. 10 is a flow chart illustrating an exemplary method of manufacturing a medical device.

Detailed Description

The present disclosure relates to devices, systems, and techniques for improving battery capacity for power delivery to electronics in an Implantable Medical Device (IMD), such as an implantable stimulation device, without increasing the overall size, volume, and/or surface area of the IMD. These techniques may be used with a neurostimulator that may provide treatment for a variety of dysfunctions, diseases, or conditions. For purposes of illustration and not limitation, use of the techniques of the present disclosure will be described below with respect to bladder dysfunction. Bladder dysfunction generally refers to a condition of bladder or urinary tract dysfunction, and may include, for example, overactive bladder, urgency, or urinary incontinence. Overactive bladder (OAB) is a patient condition that may include symptoms such as urgency with or without urinary incontinence. Urgency is a sudden, irresistible urge to urinate and may often (although not always) be associated with urinary incontinence. Urinary incontinence refers to a condition in which urine is unintentionally lost, and may include urge incontinence, stress incontinence, or stress and urge incontinence, which may be referred to as mixed urinary incontinence. As used in this disclosure, the term "urinary incontinence" includes disorders in which urination occurs when it is not desired, such as stress or urge incontinence. Other bladder dysfunction may include disorders such as non-obstructive urinary retention.

One type of therapy for treating bladder dysfunction involves the delivery of continuous or periodic electrical stimulation to a target tissue site within a patient to cause a therapeutic effect during the delivery of the electrical stimulation. For example, delivering electrical stimulation from an Implantable Medical Device (IMD) to a target treatment site (e.g., delivering stimulation to modulate a tissue site of a tibial nerve, a spinal nerve (e.g., a sacral nerve), a pudendal nerve, a dorsal genital nerve, a lower rectal nerve, a perineal nerve, or branches of any of the foregoing) may provide an immediate treatment effect for bladder dysfunction, such as a desired reduction in bladder contraction frequency. In some cases, electrical stimulation of the tibial nerve may modulate afferent nerve activity to restore urinary function during the electrical stimulation. Delivery of electrical stimulation (which may include pulsed stimulation) or other types of neural stimulation (e.g., drug delivery therapy) uses energy and depletes the battery of the IMD. Battery life and IMD function may be increased by using a larger battery at the cost of increased size and weight of the IMD implanted in the patient.

The systems, devices, and techniques described herein provide increased capacity for IMDs without increasing the overall size, volume, and/or surface area of the IMD. In some examples, an IMD battery (i.e., a battery for an IMD) is an externalized battery (e.g., a single-case battery) that is located outside of the housing of the IMD and includes only the housing of the battery cell and/or chemistry. In some examples, the externalized battery may be configured to hermetically seal the battery cell and/or battery chemistry, and the externalized battery may be configured to provide power to electronic components (e.g., electrodes, circuitry, etc.) housed within the IMD housing. For example, the housing of the externalized battery may encapsulate a volume that includes the voltaic cell (as an example), and may include an inner surface that contacts the voltaic cell and/or battery chemistry and/or material, and may include an outer surface that is exposed to the same environment (e.g., air, body tissue and/or body fluids, and/or coatings on the outer surfaces of the IMD and battery) as the outer surface of the IMD housing. In some examples, the externalized battery provides a larger battery by eliminating a portion of the IMD housing, e.g., replacing a portion of the IMD housing with a larger battery configured to be exposed to the same environment as the housing of the IMD. In some examples, the externalized battery may be a primary battery (e.g., including one or more primary battery cells) or a rechargeable battery (e.g., including one or more rechargeable battery cells). In some examples, the externalized battery may be a lithium ion battery.

The present disclosure includes a discussion of various examples, aspects, and features. Various examples, aspects, and features are contemplated for use in different combinations, unless otherwise indicated. For ease of discussion and in fact, every possible combination of features is not explicitly recited.

In some examples, a system may be configured to provide stimulation at a neural target that is located at a site remote from an affected peripheral organ. For example, the stimulation site may be located a relatively large distance from the bladder or intestine, such as the tibial nerve. The system may include a plurality of devices (e.g., implantable sensors and implantable stimulation devices) with wireless communication circuitry that allows wireless communication of information between the devices, which may provide sensing or therapeutic stimulation. For example, the wireless circuitry may be designed to use near field communication,Or otherwise have noThe wire protocol communicates.

For tibial stimulation, the techniques of this disclosure may increase the capacity of the battery by at least 1%, or at least 10%, or at least 50%, or at least 100%. In some examples, the clinician may recharge an external or expandable battery of the IMD during a visit. In this case, the IMD may look similar to the main battery cell arrangement to the patient.

For ease of discussion, various examples are discussed in connection with bladder function. It should be appreciated that bladder function is but one possible application. Aspects of the present disclosure may also be used in connection with urine, bowel and general pelvic floor dysfunction. For brevity, each type of dysfunction is not repeated for each feature or example discussed herein.

Constant or sustained stimulation may result in undesirable side effects, adaptability, less focused treatment, and an increase in energy used by the medical device delivering the treatment. For example, for tibial stimulation, the IMD may provide 30 minutes of stimulation once a week, and the patient may experience relief.

Thus, the stimulus may be cyclically turned on and off. When stimulation is cycled off, the neurostimulation device may enter a sleep mode in which the current drawn from the battery powering the neurostimulation device is very small. This may translate into longer recharging intervals and/or longer replacement intervals.

A medical device, such as an IMD, may implement the techniques described in this disclosure to deliver stimulation therapy to at least one nerve (e.g., tibial, spinal, or pelvic floor nerve) via at least one electrode electrically connected to the IMD to modulate the activity of the nerve. The electrical stimulation may be configured to modulate contractions of the detrusor muscle of the patient to cause a decrease in the frequency of bladder contractions (to reduce incontinence) or an increase in the frequency of bladder contractions (to promote voiding). The reduced frequency of bladder contractions may reduce urge to void and may reduce urgency and/or incontinence, thereby at least partially alleviating bladder dysfunction. As another example, electrical stimulation (such as electrical stimulation of the tibial nerve) may cause the patient's brain to ignore signals requesting excretion, thereby reducing the chance of the patient excreting at an undesirable time.

The neural stimulation described herein may be intended to manage bladder dysfunction, such as overactive bladder, urgency, urinary incontinence, or even non-obstructive urinary retention. For example, the stimulus may be delivered to a target tissue site that is typically used to alleviate these types of dysfunctions. Although techniques for managing bladder dysfunction are primarily described in this disclosure, these techniques may also be applied to manage other pelvic floor disorders or disorders associated with other organs, tissues, or nerves of a patient. For example, the devices, systems, and techniques described in this disclosure may alternatively or additionally be used to manage sexual dysfunction, pelvic pain, fecal urgency, or fecal incontinence. Exemplary nerves that can be targeted for treatment include tibial, sacral, pudendal, dorsal, sural, sciatic, lower rectal, fibular or perineal nerves. Exemplary organ systems that may be treated for dysfunction may include large and small intestines, stomach and/or intestines, liver and spleen, which may be modulated by delivering neural stimulation directly to the organ, to one or more nerves that innervate the organ, and/or to the blood supply to the organ. In other examples, the treatment may target the spinal cord to relieve pain. In other examples, the treatment may target the brain to treat parkinson's disease or seizure disorders.

Various examples are discussed with respect to one or more stimulation devices. It is recognized that stimulation devices may include features and functions other than electrical stimulation. Many of these additional features are explicitly discussed herein. Several exemplary features include, but are not limited to, different types of sensing capabilities and different types of wireless communication capabilities. For ease of discussion, the present disclosure does not explicitly recite every conceivable combination of additional features, such as by repeating each feature each time a different example and use of the stimulation device is discussed.

Fig. 1 is a schematic diagram illustrating an exemplary medical device 100 (also referred to as IMD 100). IMD 100 includes a device housing 102 that contains one or more electronic components, such as circuitry, antennas, electrode connections, etc. In some examples, IMD 100 may be a leadless neurostimulation device configured for delivering neurostimulation therapy. In the example shown, IMD 100 includes: a head unit 103 comprising one or more main electrodes 104; and a mounting plate 105 coupling the device housing 102 to the head unit 103. The head unit 103 comprises at least one main electrode 104 forming part of the outer surface of the head unit 103. The device housing 102 includes a secondary electrode 106 that forms a portion of the exterior surface of the device housing 102 and is positioned on the same side of the IMD 100 as the primary electrode 104. In another example, the primary electrode 104 and the secondary electrode 106 may be disposed on opposite sides of the IMD 100.

The primary electrode 104 and the secondary electrode 106 operate in conjunction with one another to provide stimulation therapy to a target treatment site (e.g., tibial nerve). The counter electrode 106 may also be referred to as a housing electrode, a can electrode, or a reference electrode. In one example, the primary electrode 104 may include a cathode and the secondary electrode 106 may include an anode. As described in more detail, in some examples, the primary electrode 104 may include an anode and the secondary electrode 106 may include a cathode. In some examples, the primary electrode 104 and the secondary electrode 106 may be characterized as bipolar pairs or systems.

The terms "primary" and "secondary" are used to distinguish between two or more electrodes configured to transmit electrical signals therebetween. These terms are not used to imply a hierarchy between the electrodes, positive and negative terminals, a total number of electrodes, or directionality of signal transmission between the electrodes. Additional information regarding the medical device 100 may be found in U.S. patent publication 2022/0096845A1, the entire contents of which are incorporated herein by reference.

In the example shown, IMD 100 also includes an externalized battery 108. The externalized battery 108 includes a battery housing 109 that is located outside of the device housing 102 and is attachable to the device housing 102, for example, via an attachment 107. In some examples, the device housing 102 and the battery housing 109 may include biocompatible materials, such as titanium, ceramics, such as single crystal alumina (e.g., sapphire), polycrystalline alumina, and the like. For example, the device housing 102 and the battery housing 109 are configured to be implantable within a patient. In some examples, one or both of the device housing 102 and the battery housing 109 may be configured to form an airtight seal to enclose a volume and/or configured to be joined to metal, for example, via the attachment 107. In some examples, the attachment 107 may include an adhesive, a mechanical mechanism (configured to hold the battery housing 109 proximate and/or adjacent to the device housing 102), a weld (e.g., a welded or titanium weld ring or collar including diffusion bonding), or the like.

In some examples, battery 108 is configured to be modular, e.g., changeable or exchangeable, without changing the coupling connections and/or circuitry of IMD 100. For example, the battery 108 may be detached at the attachment 107 and removed from the IMD 100. A separate externalized battery (e.g., a new or different externalized battery that may be smaller, the same size, or larger than the externalized battery 108) may then be attached to the device housing 102 via an attachment 107 (e.g., adhesive, mechanical coupling, welding, bonding, etc.). If such a separate external battery is smaller or larger than external battery 108 but otherwise substantially similar to external battery 108, the overall size of IMD 100 may vary, however, the battery capacity per IMD 100 volume of the separate external battery is greater than the alternative separate and/or dual-case battery.

In some examples, IMD 100 includes a biocompatible electrical insulator (not shown). For example, the outer surfaces of the device housing 102 and the battery housing 109 may be configured to be in contact with (e.g., coated with) parylene, except for the primary electrode 104 and the secondary electrode 106. The parylene coating may be configured to electrically isolate the device housing 102 and the battery housing 109 from the tissue and/or body fluids of the patient and/or to increase the electrical resistance between the device housing 102 (and the battery housing 109) and the tissue and/or body fluids of the patient (except for the surface areas of the primary electrode 104 and the secondary electrode 106).

In the example shown, the externalized battery 108 is located outside of the device housing 102, and the battery housing 109 is configured to be hermetically sealed. For example, the battery housing 109 is configured to hermetically seal one or more battery cells, voltaic battery cells, battery chemistries and/or materials, etc., and provide one or more electrical connections or points of contact to the device housing 102 and/or one or more electronic components housed within the device housing 102. In other words, the externalized battery 108 is configured to provide power to the electronic components housed within the device housing 102.

In some examples, the battery housing 109 includes a metal (such as titanium) or a ceramic (such as sapphire). The battery housing 109 includes an inner surface configured to contact a volume hermetically sealed by the battery housing 109, the volume containing one or more battery cells, one or more voltaic battery cells, and/or battery material or battery chemistry. In some examples, the inner surface of the battery housing 109 may be in contact with one or more battery cells, one or more voltaic battery cells, and/or battery materials or battery chemistries. In some examples, the battery housing 109 includes an outer surface configured to be in contact with the same environment as the outer surface of the device housing 102. For example, the outer surface of the battery housing 109 may be in contact with body tissue and/or bodily fluids, or with a biocompatible electrical insulator, e.g., the outer surface of the battery housing 109 may be configured to be coated with parylene.

The inner and outer surfaces of the battery housing 109 are, for example, opposing surfaces of the same battery housing wall. In other words, IMD 100 may include a single-case externalized battery 108 that is located external to device housing 109 and configured to increase the battery capacity of IMD 100 without increasing the overall size, volume, and/or surface area of IMD 100 relative to an IMD that includes a battery within the IMD housing (e.g., within device housing 102 if device housing 102 is expanded to include the surface area and/or volume of battery housing 102).

In some examples, the battery housing 109 may include a conductive material (e.g., titanium) and be configured to be separate from the positive and negative terminals of the battery 108, e.g., the battery housing 109 is at a neutral or floating potential and may be referred to as "housing neutral". In other examples, the battery housing 109 is configured to connect to or include terminals of a battery. For example, the battery housing 109 may be configured or electrically connected to the positive terminal of the battery 108, and may be "positive housing," e.g., the battery housing may be at a positive potential. In examples where battery housing 109 is neutral or positive, IMD 100 may be configured to electrically isolate battery housing 109 from device housing 102 and primary and secondary electrodes 104, 106. In other examples, the battery housing 109 may be configured or electrically connected to the negative terminal of the battery 108, and may be "housing negative," e.g., the battery housing may be at a negative potential.

In some examples, the battery housing 109 may be in electrical contact with the device housing 102. For example, the battery housing 109 may have a low resistance path between the device housing 102 and the battery housing 109, e.g., the battery housing 109 may be shorted or "shunted" to the device housing 102. In such examples, the battery housing 109 may be or may be connected to the negative terminal of the battery 108 and the casing is negative. For example, if the battery housing 109 is in electrical contact with the housing 102, a direct current path may exist from the secondary electrode 106 to the battery housing 109, e.g., the battery housing 109 may shunt to the secondary electrode 106 via the device housing 102. If the battery housing 109 is not in direct electrical contact with the device housing 102 such that there is no direct (e.g., relatively low resistance) path between the device housing 102 and the battery housing 109, the battery housing 109 may still shunt to the auxiliary electrode 106 via the patient's tissue and/or body fluid (e.g., by being in close or relatively close proximity to the device housing 102). If the battery housing 109 is positive, the IMD 100 may "push" charge into the positive terminal of the battery 108, thereby degrading the battery 108. If the battery enclosure 109 is shell neutral, charge may accumulate on at least a portion of the interior surface of the battery enclosure 109 and cause the battery cells, voltaic cells, battery materials, or chemicals contained within the battery enclosure 109 to deplete, thereby degrading the battery 108. If the battery housing 109 is positive or negative in housing, the IMD 100 may "shunt" charge, for example, that may accumulate on at least a portion of the interior surface of the battery housing 109 and cause the battery cells, voltaic cells, battery materials, or chemicals contained within the battery housing 109 to be depleted, thereby degrading the battery 108. For example, if IMD 100 provides a stimulus with a sufficiently high voltage, the housing (e.g., battery housing 109) may be driven well above the cathodic potential, resulting in electrolyte reduction at the housing wall.

If the battery housing 109 is negative in magnitude, the secondary electrode 106 is no longer floating and is connected to "ground," e.g., the lowest potential (e.g., voltage) of the system or circuit, which in the illustrated example is the negative terminal of the battery 108 when a direct electrical path exists between the secondary electrode 106 and the battery housing 109. Thus, the flow of current between the primary electrode 104 and the secondary electrode 106 is reversed (through patient tissue and/or body fluid), e.g., the primary electrode 104 is the anode and the secondary electrode 106 is the cathode, e.g., the sink of current or "return electrode" for the electrical stimulation signals of the IMD 100. IMD 100 may then "push" charge into the negative terminal of battery 108, which is the normal operating condition of battery 108.

Fig. 2 is a schematic diagram illustrating an exemplary medical device 200 (also referred to as IMD 200). IMD 200 includes a device housing 102 that contains one or more electronic components, such as circuitry, antennas, electrode connections, etc. In some examples, IMD 200 may be a leadless neurostimulation device configured for delivering neurostimulation therapy, and IMD 200 may be substantially similar to IMD 100 described above, except that IMD 200 includes an insulator 207.

In the example shown, the insulator 207 may be substantially similar to the attachment 107 described above, except that the insulator 207 includes an electrical insulator configured to electrically isolate the device housing 102 from the battery housing 109, separate the device housing from the battery housing, and/or increase the electrical resistance between the device housing and the battery housing. Insulator 207 may comprise any suitable material configured to both attach device housing 102 and battery housing 109 and increase the electrical resistance between the device housing and the battery housing. For example, the insulator 207 may comprise a ceramic, such as sapphire. In the example shown, insulator 207 includes ceramic 210 and attachment portions 212 and 214. The attachment portions 212 and 214 may include titanium weld ferrules that may be soldered or diffusion bonded to the ceramic 210 and configured to attach the device housing 102 and the battery housing 109, respectively, to the ceramic 210. The attachment portions 212 and 214 may form an airtight seal between the device housing 102 and the ceramic 210 and between the battery housing 109 and the ceramic 210, respectively. In some examples, the ceramic 210 may be a ceramic ring and may extend around a circumference or outer dimension of the device housing 102 and/or the battery 108. In some examples, the outer surface of the insulator 210 (e.g., any or all of the ceramic 210 and the attachment portions 212, 214) may include an outer surface that is coplanar with at least a portion of the device housing 102 and/or the battery 108. In some examples, the insulator 207 may define an interior cavity between the device housing 102 and the battery housing 109, and the interior cavity may enclose a volume when the battery housing 109 and the device housing 102 are attached via the insulator 207.

In some examples, insulator 207 may be configured to house one or more components within a lumen and/or volume. Examples of one or more components within the lumen and/or volume include electrical connectors or conductors, circuitry, one or more antennas (such asOr other wireless antenna) and associated communication circuitry, etc. For example, ceramic 210 may be at least partially transparent to radio frequency electromagnetic waves (e.g., RF communication waves), and insulator 207 may be configured to house a material such as +.>Communication means of the antenna. In some examples, IMD 200 is configured to improve wireless communication of an implantable medical device, for example, via RF transparent ceramic 210.

As discussed above with respect to fig. 1 and similar functions with respect to fig. 2, for example, when IMD 200 is implanted, battery housing 109 may shunt to device housing 102 via tissue and/or body fluids of a patient. In some examples, IMD 200 may include biocompatible electrical insulators, such as parylene coatings disposed on the outer surfaces of device housing 102, head unit 103, battery housing 109, and optionally on insulator 207, except for the surfaces of primary electrode 104 and secondary electrode 106. The biocompatible electrical insulator may be configured to electrically isolate and/or separate the battery housing 109 from the device housing 102 or otherwise increase the electrical resistance between the battery housing 109 and the device housing 102.

In the example shown, the battery housing 109 may be electrically isolated from the device housing 102 via the insulator 207 and the biocompatible electrical insulator, e.g., to remove a direct or low resistance electrical path between the battery housing 109 and the device housing 102. Electrically isolating battery housing 109 from device housing 102 (e.g., as well as from electrodes 104, 106) may enable IMD 200 to operate in a biphasic mode (e.g., a mode including two electrical stimulation phases). The two modes may be a first mode or "charging" mode in which IMD 200 causes current to flow between electrodes 104, 106 through tissue and/or body fluid in a first direction, and a second mode or "active recharging" mode in which IMD 200 causes current to flow between electrodes 104, 106 through tissue and/or body fluid in a second direction opposite the first direction.

For example, regardless of whether battery housing 109 is a terminal of battery 108, whether the housing is positive, the housing is neutral, or the housing is negative, IMD 200 may be configured to reverse current flow between primary electrode 104 and secondary electrode 106 through tissue and/or body fluids of the patient without adversely affecting the efficacy of battery 108 and/or stimulation. For example, IMD 200 may provide electrical stimulation with primary electrode 104 as the cathode and secondary electrode 106 as the anode. That is, circuitry with IMD 200 may be configured to connect (e.g., via a switch) primary electrode 104 to the negative terminal of battery 108 and secondary electrode 106 to the positive terminal of battery 108, such that current flows between electrodes 106, 104 through the patient's tissue and/or body fluids and delivers stimulation. The current flowing through the tissue and/or body fluids may alter and/or charge the tissue and/or body fluids, and when the charged tissue and/or body fluids discharge when the IMD 200 shuts off the flow of current (e.g., disconnects the electrodes 104, 106 from the terminals of the battery 108), the current may flow through the tissue and/or body fluids. Thus, IMD 200 may provide passive recharging by removing current and allowing tissue and/or body fluids to release localized charge accumulation for a certain period of time.

In other examples, IMD 200 may be configured to provide active recharging, for example, to switch the direction of current flow through tissue and/or body fluids and thereby remove charge accumulation in the tissue and/or body fluids. For example, after connecting the primary electrode 104 to the negative terminal of the battery 108 and the secondary electrode 106 to the positive terminal of the battery 108 to cause current to flow between the electrodes 106, 104 in a first direction through tissue and/or body fluids of the patient, the IMD 200 may connect the primary electrode 104 to the positive terminal of the battery 108 and the secondary electrode 106 to the negative terminal of the battery 108 to cause current to flow between the electrodes 106, 104 in a second, opposite direction through tissue and/or body fluids of the patient for a certain period of time.

IMD 200 may be configured to provide passive or active recharging with battery housing 109 in a case where the housing is positive, the housing is neutral, or the housing is negative. In some examples, although not required, IMD 100 may be configured to provide only passive recharging if battery housing 109 is negative in housing, for example because sub-electrode 106 is shunted to the negative terminals of battery housing 109 and battery 108 and cannot switch to the positive terminal. In some examples, a biocompatible electrical insulator disposed on a surface of IMD 200 may be at least partially damaged (e.g., include and/or form a notch, cutout, void, etc.), thereby reducing the efficacy of electrically isolating battery housing 109 from device housing 102 and/or electrodes 104, 106. The battery housing 109 may be configured to be negative in the case, for example, even when electrically isolated from the device housing 102 and/or the electrodes 104, 106.

In some examples, IMD 100 and/or IMD 200 may be a constant current device, e.g., as opposed to a constant voltage device. For example, the IMD 200 may be configured to provide electrical stimulation by controlling the stimulation circuitry to have a constant current rather than applying a constant voltage to one or both of the electrodes 104, 106.

In some examples, the IMD may include an external battery that includes a polymer encasement (not shown). For example, IMD 100 and/or IMD 200 may include an external battery that is substantially similar to battery 108, except that a polymer encasement is provided between battery housing 109 and one or more battery cells, one or more voltaic battery cells, battery material, and/or battery chemistry of the battery. In some examples, a battery including a polymer pack housing may allow for increased battery capacity by reducing the pack housing thickness (e.g., battery pack housing wall thickness). In examples where IMD 100 includes a battery that includes a polymer encasement, battery housing 109 may no longer be a terminal of the battery and may enable IMD 100 to provide active recharging.

Fig. 3 is a schematic diagram illustrating an exemplary medical device 300 (also referred to as IMD 300). IMD 300 includes a device housing 302 that includes an electrically insulating material (e.g., a ceramic such as sapphire) and is configured to contain one or more electronic components, such as circuitry, antennas, electrode connections, etc., therein. In some examples, IMD 300 may be a leadless neurostimulation device configured for delivering neurostimulation therapy, and IMD 300 may be substantially similar to IMDs 100 and 200 described above, except that IMD 300 includes an electrically insulating device housing 302 instead of device housing 102 and does not include ceramic 210. The device housing 302 may be substantially similar to the device housing 102, except that the device housing 302 is electrically insulative.

In the example shown, the attachment portions 212 and 214 may include titanium weld ferrules that may be soldered or diffusion bonded to the device housing 302 and configured to attach the head unit 103 and the battery housing 109, respectively, to the device housing 302. The secondary electrode 106 may be brazed or diffusion bonded to the device housing 302, for example, via a weld collar (not shown). In other examples, the secondary electrode 106 may be attached to the device housing 302 via any suitable attachment method or material (e.g., adhesive, mechanical coupling, etc.). In some examples, the outer surface of the device housing 302 (e.g., any or all of the device housing 302 and the attachment portions 212, 214) may include an outer surface that is coplanar with at least a portion of the device housing 102 and/or the battery 108.

As discussed above, battery housing 109 may shunt to IMD 100 or device housing 102 of IMD 200 via tissue and/or body fluids of a patient, for example, when IMD 200 is implanted. Similarly, the battery housing 109 may shunt to one or both of the electrodes 104, 106 via tissue and/or body fluids of the patient, although the path length through the tissue and/or body fluids is increased due to the device housing 302 comprising electrically insulating material. In some examples, IMD 300 may include biocompatible electrical insulators, such as parylene coatings disposed on the outer surfaces of device housing 302, head unit 103, and battery housing 109, except for the surfaces of primary electrode 104 and secondary electrode 106. The biocompatible electrical insulator may be configured to electrically isolate and/or separate the battery housing 109 from the electrodes 104, 106 or otherwise increase the electrical resistance between the battery housing 109 and the electrodes 104, 106.

In some examples, device housing 302 may be configured to improve wireless power transfer between IMD 300 and an external power source (e.g., external to a patient in which IMD 300 is implanted). For example, IMD 300 (or IMD 200 or IMD 100) may include a wireless power receiver coil configured to wirelessly receive power, e.g., within device housing 102 (or device housing 302), to recharge battery 108. With an externalized battery 108. The wireless power receiver coil of IMD 300 may be smaller and have a reduced aperture relative to an IMD having a battery within its device housing, e.g., the wireless power receiver coil may extend substantially the entire width and length of the device housing. Since the device housing 302 (or the device housing 102) may have a reduced length (or width), the aperture of the wireless power receiver coil may be reduced accordingly. The device housing 302 may be substantially transparent to electromagnetic fields and/or waves used to transmit power and may increase the efficiency of power transmission through the device housing 302. In some examples, the device housing 302 may compensate for a smaller aperture of the wireless power receiver coil, and in other examples, the device housing 302 may enable an increase and/or improvement in an amount and/or rate of power wirelessly transmitted via the wireless power receiver coil housed within the device housing 302.

IMD 300 may be configured to provide passive or active recharging with battery housing 109 in a case where the housing is positive, the housing is neutral, or the housing is negative. In some examples, a biocompatible electrical insulator disposed on a surface of IMD 300 may be at least partially damaged (e.g., include and/or form a notch, cutout, void, etc.), thereby reducing the efficacy of electrically isolating battery housing 109 from electrodes 104, 106. The battery housing 109 may be configured to be negative in the case, for example, even when electrically isolated from the electrodes 104, 106.

In some examples, the device housing 302 may be configured to house one or more antennas (such asOr other wireless antenna) and associated communication circuitry, etc. For example, the device housing 302 may be at least partially transparent to radio frequency electromagnetic waves (e.g., RF communication waves), and the device housing 302 may be configured to house a device such as +.>Communication means of the antenna. In some examples, IMD 300 is configured to improve wireless communication of an implantable medical device, for example, via RF transparent device housing 302.

Fig. 4 is a schematic diagram illustrating an exemplary medical device 400 (also referred to as IMD 400). IMD 400 includes a device housing 102, a portion of which may include an electrically insulating portion 402 that includes an electrically insulating material (e.g., a ceramic such as sapphire). In some examples, IMD 400 may be a leadless neurostimulation device configured for delivering neurostimulation therapy, and IMD 400 may be substantially similar to IMD 300 described above, except IMD 400 includes an electrically insulating portion 402 instead of device housing 302 and includes an attachment 107 instead of attachment portions 212, 214.

Similar to the device housing 302, the electrically insulating portion 402 may be configured to improve wireless power transfer and electrically isolate the secondary electrode from the housing 102. In some examples, the secondary electrode 106 may be attached to the electrically insulating portion 402 similar to the device housing 302 described above. In other examples, secondary electrode 106 may be located and/or attached to a surface of housing 102, e.g., on an opposite side of IMD 400. Similar to IMDs 100-300, at least a portion or all of the outer surface of IMD 400 (e.g., housing 102, head unit 103, battery housing 109, and electrically insulating portion 402) may be coated with and/or otherwise in contact with a biocompatible electrical insulator, except for the surfaces of electrodes 104, 106.

IMD 400 may be configured to provide passive or active recharging with battery housing 109 in a case where the housing is positive, the housing is neutral, or the housing is negative. In some examples, a biocompatible electrical insulator disposed on a surface of IMD 400 may be at least partially damaged (e.g., include and/or form a notch, cutout, void, etc.), thereby reducing the efficacy of electrically isolating battery housing 109 from device housing 102 and/or electrodes 104, 106. The battery housing 109 may be configured to be negative in the case, for example, even when electrically isolated from the device housing 102 and/or the electrodes 104, 106.

In some examples, the device housing 102 may be configured to house one or more antennas (such asOr other wireless antenna) and associated communication circuitry, etc. For example, the electrically insulating portion 402 may be at least partially transparent to radio frequency electromagnetic waves (e.g., RF communication waves), and the device housing 102 may be configured to house a device such as +.>Communication means of the antenna. In some examples, IMD 400 is configured to improve wireless communication of an implantable medical device, for example, via RF transparent electrically insulating portion 402.

Fig. 5 is a schematic diagram illustrating an exemplary medical device 500 (also referred to as IMD 500). IMD 500 includes an external battery 508, which may be substantially similar to external battery 108, except that external battery 508 includes an electrically insulating battery housing 509 (e.g., a ceramic such as sapphire) instead of battery housing 109. In some examples, IMD 500 may be a leadless neurostimulation device configured for delivering neurostimulation therapy, and IMD 500 may be substantially similar to IMD 200 described above, except that IMD 500 includes an external battery 508 instead of external battery 108.IMD 500 may be configured to provide passive or active recharging.

Fig. 6 is a conceptual diagram illustrating a patient's leg with IMD 100 implanted near its tibial nerve 110. In the example of fig. 2, IMD 100 is implanted near tibial nerve 110 in a leg 111 of a patient. For example, IMD 100 may deliver neural stimulation to a patient to manage bladder dysfunction, such as overactive bladder, urgency, or urinary incontinence.

Fig. 7 is a conceptual diagram illustrating an exemplary system 10 for managing delivery of neural stimulation to a patient 14 to manage bladder dysfunction, such as overactive bladder, urgency, or urinary incontinence. Treatment system 10 includes IMD 16 (e.g., an exemplary medical device) coupled to leads 18, 20, and 28 and sensor 22. In some examples, IMD 16 may be substantially similar to any of IMDs 100, 200, 300, 400, or 500, except IMD 16 may be a leadless neurostimulation device instead of a leadless neurostimulation device. For example, IMD 16 may include an external battery 17, which may be substantially similar to external batteries 108 and/or 508 described above. System 10 also includes an external programmer 24 configured to communicate with IMD 16 via wireless communication. IMD 16 is generally used as a therapeutic device that delivers electrical nerve stimulation to a target tissue site proximate to, for example, the tibial, spinal, sacral, pudendal, dorsal genitalia, lower rectal, perineal, or other pelvic nerve or branches of any of the foregoing. IMD 16 provides electrical stimulation to patient 14 by generating and delivering programmable electrical stimulation signals (e.g., in the form of electrical pulses or electrical waveforms) to target treatment sites proximate lead 28, and more specifically proximate electrodes 29A-29D (collectively "electrodes 29") disposed proximate the distal end of lead 28.

IMD 16 may be surgically implanted within patient 14 at any suitable location within patient 14, such as near the pelvis. In some examples, IMD 16 may be implanted in a subcutaneous location in the lower abdominal side or lower back or upper buttock side. IMD 16 has a biocompatible housing, which may be formed of titanium, stainless steel, liquid crystal polymer, or the like. Proximal ends of leads 18, 20, and 28 are electrically and mechanically coupled to IMD 16, directly or indirectly, e.g., via respective lead extensions. Electrical conductors disposed within the lead body of leads 18, 20, and 28 electrically connect sensing electrodes (e.g., electrodes 19A, 19B, 21A, and 21B) and stimulation electrodes (such as electrode 29) to sensing circuitry and stimulation delivery circuitry (e.g., stimulation generator) within IMD 16. In the example of fig. 7, leads 18 and 20 carry electrodes 19A, 19B (collectively, "electrodes 19") and electrodes 21A, 21B (collectively, "electrodes 21"), respectively. Electrodes 19 and 21 may be positioned to sense the impedance of bladder 12, which may increase as the volume of urine within bladder 12 increases.

External programmer 24 may receive user input identifying voiding events, perceived filling levels, and the like. The user input may be in the form of a drain log analyzed by external programmer 24 or IMD 16 or a personal user input associated with a corresponding drain event, leak, or any other event related to a phase of a physiological cycle. External programmer 24 and/or IMD 16 may use the user input to generate an estimated filling period and determine when to exit sleep mode and deliver stimulation and when to inhibit stimulation and enter sleep mode. In other words, one or more physiological markers may be identified based on user input and utilized to determine when to enter and exit sleep mode. User input may be used in addition to or in lieu of sensors such as electrodes 19A and 21A to detect physiological markers.

One or more medical leads (e.g., leads 18, 20, and 28) may be connected to IMD 16 and surgically or percutaneously tunneled to place one or more electrodes carried by the distal end of the respective lead at a desired nerve or muscle site, for example, one of the previously listed target treatment sites (such as a tissue site proximate to the tibial, spinal, sacral, or pudendal nerve). For example, lead 28 may be positioned such that electrode 29 delivers electrical stimulation to the tibial, spinal, sacral, or pudendal nerve to reduce the frequency and/or magnitude of contractions of bladder 12. Additional electrodes of lead 28 and/or electrodes of another lead may also provide additional stimulation treatments to other nerves or tissue. In fig. 7, leads 18 and 20 are placed in a first position and a second position, respectively, adjacent the outer surface of the wall of bladder 12. In other examples of therapy system 10, IMD 16 may be coupled to more than one lead that includes electrodes for delivering electrical stimulation to different stimulation sites within patient 14 (e.g., to target different nerves).

The illustrated number and configuration of leads 18, 20, and 28 and the electrodes carried by leads 18, 20, and 28 are merely exemplary. Other configurations of leads and electrodes are also contemplated, such as number and location. For example, in other implementations, IMD 16 may be coupled to additional leads or lead segments having one or more electrodes positioned at different locations in the spinal or pelvic region proximate patient 14. The additional leads may be used to deliver different stimulation treatments or other electrical stimulation to corresponding stimulation sites within the body of the patient 14 or to monitor at least one physiological signature of the patient 14.

In some examples, IMD 16 delivers electrical stimulation based on a stimulation program to at least one of a tibial nerve, a spinal nerve (such as the sacral nerve), a pudendal nerve, a dorsal genital nerve, a lower rectal nerve, or a perineal nerve to provide a therapeutic effect that reduces or eliminates a dysfunctional state such as overactive bladder. The desired therapeutic effect may be an inhibitory physiological response associated with the excretion of the patient 14, such as a reduction in bladder contraction frequency by a desired level or degree (e.g., percentage).

The stimulation program may define various parameters of the stimulation waveform and electrode configuration that result in the delivery of a predetermined stimulation intensity to the targeted nerve or tissue. In some examples, the stimulation program defines parameters for at least one of: the current or voltage amplitude of the stimulation signal, the frequency or pulse rate of the stimulation, the shape of the stimulation waveform, the duty cycle of the stimulation, the pulse width of the stimulation, and/or the combination of electrodes 29 used to deliver the stimulation and the respective polarities of the subset of electrodes 29. Together, these stimulation parameter values may be used to define a stimulation intensity (also referred to herein as a stimulation intensity level). In some examples, if the stimulation pulses are delivered in bursts, the burst duty cycle may also contribute to the stimulation intensity. Moreover, regardless of intensity, the particular pulse width and/or pulse rate may be selected from a range suitable to cause the desired therapeutic effect after termination of stimulation and optionally during stimulation. Further, as described herein, the periods during which stimulation is delivered may include an on period and an off period (e.g., duty cycle or pulse train of pulses), wherein the short inter-pulse duration even when no pulses are delivered is considered part of stimulation delivery. For example, IMD 16 may not enter sleep mode during the short inter-pulse duration when no pulses are delivered. For example, the short inter-pulse duration when no pulses are delivered during an on cycle is still considered part of stimulation delivery, but IMD 16 may be considered to not deliver stimulation during an off cycle.

Although described above with respect to stimulation that IMD 16 may deliver, in one or more examples, IMDs 100, 200, 300, 400, and 500 may be configured to deliver similar therapies as the examples described above. However, in some examples, IMDs 100, 200, 300, 400, and 500 may deliver stimulation for a limited amount of time and then remain in sleep mode for an extended period of time (e.g., delivering multiple stimulation pulses for 30 minutes and in sleep mode for 23.5 hours, 47.5 hours, etc.).

The system 10 may also include an external programmer 24, as shown in fig. 7. External programmer 24 may be a clinician programmer or a patient programmer. In some examples, external programmer 24 may be a wearable communication device in which the therapy request input is integrated into a key fob or wristwatch, a handheld computing device, a smart phone, a computer workstation, or a networked computing device. External programmer 24 may include a user interface configured to receive input from a user (e.g., patient 14, patient care provider, or clinician). In some examples, the user interface includes, for example, a keypad and a display, which may be, for example, a Liquid Crystal Display (LCD) or a Light Emitting Diode (LED) display. The keypad may take the form of an alphanumeric keypad or a reduced set of keys associated with a particular function. Additionally or alternatively, the external programmer 24 may include a peripheral pointing device, such as a mouse, via which a user may interact with the user interface. In some examples, the display of external programmer 24 may include a touch screen display, and a user may interact with external programmer 24 via the display. It should be noted that a user may also interact with external programmer 24 and/or IMD 16 remotely via a networked computing device. In some examples, external programmer 24 may be configured to interoperate with any of IMDs 100, 200, 300, 400, or 500 (e.g., leadless IMDs).

A user, such as a physician, technician, surgeon, electrophysiologist, or other clinician, may also interact with external programmer 24 or another separate programmer (not shown), such as a clinician programmer, to communicate with IMD 16. Such users may interact with the programmer to retrieve physiological or diagnostic information from IMD 16. The user may also interact with the programmer to program IMD 16, for example, to select values of stimulation parameters utilized by IMD 16 to generate and deliver stimulation and/or values of other operating parameters of IMD 16, such as the magnitude of stimulation energy, the period of stimulation requested by the user, or the period of prevention of stimulation, or any other such user therapy customization. As discussed herein, the user may also provide input to the external programmer 24 indicating physiological events such as bladder filling level perception and voiding events.

For example, a user may use a programmer to retrieve information from IMD 16 regarding the frequency of contractions and/or voiding events of bladder 12. As another example, a user may use a programmer to retrieve information from IMD 16 regarding the performance or integrity of IMD 16 or other components of system 10, such as leads 18, 20, and 28 or a power source of IMD 16. In some examples, if a system condition is detected that may affect the efficacy of the treatment, the information may be presented to the user as an alert.

Fig. 8 is a block diagram illustrating an exemplary configuration of an IMD. As shown in fig. 8, IMD 32 (which may be an example of leadless IMDs 100-500 or leadless IMD 16) includes sensor 22, processor circuitry 53, stimulation circuitry 52, impedance circuitry 54, memory 56, telemetry circuitry 58, sleep control circuitry 70, isolation interface circuitry 72, and power supply 60. In other examples, IMD 32 may include a greater or lesser number of components. For example, where IMD 32 represents IMDs 100-500, IMD 32 does not include leads, but rather electrodes are disposed on a surface of IMD 32.

In general, IMD 32 may include any suitable hardware arrangement, alone or in combination with software and/or firmware, for performing techniques attributed to IMD 32 and components of IMD 32. In various examples, IMD 32 may include one or more processors, such as one or more microprocessors, digital Signal Processors (DSPs), application Specific Integrated Circuits (ASICs), field Programmable Gate Arrays (FPGAs), or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components. In various examples, IMD 32 may also include a memory 56, such as Random Access Memory (RAM), read Only Memory (ROM), programmable Read Only Memory (PROM), erasable Programmable Read Only Memory (EPROM), electrically Erasable Programmable Read Only Memory (EEPROM), flash memory, which includes executable instructions for causing the one or more processors to perform actions attributed to them. Furthermore, although processor circuitry 53, stimulation circuitry 52, impedance circuitry 54, and telemetry circuitry 58 are described as separate circuitry, in some examples processor circuitry 53, stimulation circuitry 52, impedance circuitry 54, and telemetry circuitry 58 are functionally integrated. In some examples, processor circuitry 53, stimulation circuitry 52, impedance circuitry 54, and telemetry circuitry 58 correspond to separate hardware units, such as a microprocessor, ASIC, DSP, FPGA, or other hardware unit. In further examples, any of processor circuitry 53, stimulation circuitry 52, impedance circuitry 54, and telemetry circuitry 58 may correspond to a plurality of separate hardware units, such as a microprocessor, ASIC, DSP, FPGA, or other hardware unit.

Memory 56 stores a therapy program 66 that specifies stimulation parameter values and electrode combinations for the electrical stimulation provided by IMD 32. Therapy program 66 may also store information regarding the determination and use of physiological parameters, information regarding physiological cycles and/or dysfunctional states, or any other information needed by IMD 32 to deliver stimulation therapy based on one or more physiological stimuli of patient 14. In some examples, the memory 56 also stores bladder data 69 that the processor circuitry 53 can use to control the timing of the delivery of the electrical stimulation (e.g., the phases of the physiological cycle defining when to deliver and inhibit stimulation). For example, the bladder data 69 may include a threshold or baseline value of at least one of bladder impedance, bladder pressure, afferent nerve signals, bladder contraction frequency, or external urinary sphincter EMG template that is used as a physiological marker of the associated physiological cycle. Bladder data 69 may also include timing information and physiological markers associated with physiological events, such as voiding events.

Memory 56 may also store status and memory information 68. For example, when IMD 32 is about to enter a particular mode, processor circuitry 53 may store certain state and memory information in state and memory information 68. Processor circuitry 53 may then access state and memory information 68 when IMD 32 is exiting the particular mode, which may be used by the processor circuitry to restore IMD 32 to a normal operating state. The status and memory information may include time information indicating when to enter sleep mode, expected exit time, length of time for last therapy delivery, etc. The status and memory information may also include information regarding the sensor acquisition and treatment sequence. The status and memory information may include algorithm status and data for ongoing assessment, such as bladder filling calculations or therapy titration calculations. The status and memory information may also include diagnostic data for the device status, such as battery voltage, electrode impedance, and/or telemetry log.

Information related to sensed bladder contractions, bladder impedance, and/or posture of the patient 14 may be stored in bladder data 69. Bladder data 69 may be retrieved by the user and/or used by processor circuitry 53 to adjust stimulation parameters (e.g., amplitude, pulse width, and pulse rate). In some examples, the memory 56 includes separate memory for storing instructions, electrical signal information, stimulation programs 66, status and memory information 68, and bladder data 69. In some examples, processor circuitry 53 selects new stimulation parameters of therapy program 66 or selects a new stimulation program from stimulation programs 66 for electrical stimulation delivery based on patient inputs or sensor signals. In some examples, the processor circuitry 53 may use the bladder data 69 to determine the efficacy of the therapy program and may adjust the time period of stimulation and the suppression time period of stimulation and associated operational and sleep modes based on the determined efficacy of the therapy program.

Generally, stimulation circuitry 52 generates and delivers electrical stimulation under the control of processor circuitry 53. As used herein, controlling electrical stimulation delivery may also include controlling termination of stimulation to achieve different stimulation phases and non-stimulation phases. In some examples, processor circuitry 53 controls stimulation circuitry 52 by accessing memory 56 to selectively access at least one of stimulation programs 66 and load the at least one stimulation program into stimulation circuitry 52. For example, in operation, processor circuitry 53 may access memory 56 to load one of stimulation programs 66 to stimulation circuitry 52. In other examples, stimulation circuitry 52 may access memory 56 and load one of stimulation programs 66.

By way of example, the processor circuitry 53 may access the memory 56 to load one of the stimulation programs 66 to the stimulation circuitry 52 for delivering electrical stimulation to the patient 14. The clinician or patient 14 may select a particular stimulation program from the list of stimulation programs 66 using a programming device such as the external programmer 24 or a clinician programmer. Processor circuitry 53 may receive the selection via telemetry circuitry 58. The stimulation circuitry 52 delivers electrical stimulation to the patient 14 for an extended period of time, such as a number of minutes, hours, days, weeks, or until the patient 14 or clinician manually stops or changes the procedure, according to the selected procedure.

Therapy delivery circuitry 52 delivers electrical stimulation according to the stimulation parameters. In some examples, stimulation circuitry 52 delivers electrical stimulation in the form of electrical pulses. In such examples, the relevant stimulation parameters may include voltage amplitude, current amplitude, pulse rate, pulse width, duty cycle, or a combination of electrodes 29 used by stimulation circuitry 52 to deliver the stimulation signal. In other examples, stimulation circuitry 52 delivers electrical stimulation in the form of a continuous waveform. In such examples, the relevant stimulation parameters may include voltage or current amplitude, frequency, shape of the stimulation signal, duty cycle of the stimulation signal, or a combination of electrodes 29 used by stimulation circuitry 52 to deliver the stimulation signal.

In the example of fig. 8, stimulation circuitry 52 drives electrodes on a single lead 28. In particular, stimulation circuitry 52 delivers electrical stimulation to tissue of patient 14 via selected electrodes 29A-29D carried by leads 28. The proximal end of lead 28 extends from the housing of IMD 32, and the distal end of lead 28 extends to a target treatment site such as a tibial nerve, a spinal nerve (e.g., S3 nerve), or a treatment site within the pelvic floor such as a tissue site proximate to the sacral nerve, pudendal nerve, dorsal genital nerve, lower rectal nerve, perineal nerve, lower abdominal nerve, urethral sphincter, or any combination thereof. In other examples, stimulation circuitry 52 may deliver electrical stimulation using electrodes on more than one lead, and each of the leads may carry one or more electrodes. The leads may be configured as axial leads with ring electrodes or segmented electrodes and/or paddle leads with electrode pads arranged in a two-dimensional array. The electrodes may operate in a bipolar or multipolar configuration with other electrodes, or may operate in a monopolar configuration with reference to the electrodes carried by the device housing or "can" of IMD 32. For example, IMD 32 may be configured to operate in a bipolar configuration with an external battery 60 (e.g., power supply 60 described below) in the negative housing.

Telemetry circuitry 58 includes any suitable hardware, firmware, software, or any combination thereof for communicating with another device, such as external programmer 24 (fig. 7). Under control of processor circuitry 53, telemetry circuitry 58 may receive downlink telemetry (e.g., patient input) from external programmer 24 and transmit uplink telemetry (e.g., alarms) to external programmer by way of an antenna, which may be internal and/or external. Processor circuitry 53 may provide data to be uplink transmitted to external programmer 24 and control signals for telemetry circuitry within telemetry circuitry 58 and receive data from telemetry circuitry 58.

In general, processor circuitry 53 may control telemetry circuitry 58 to exchange information with external programmer 24 and/or another device external to IMD 32. Processor circuitry 53 may transmit the operational information and receive stimulation programs or stimulation parameter adjustments via telemetry circuitry 58. Moreover, in some examples, IMD 32 may communicate with other implanted devices such as a stimulator, control device, or sensor via telemetry circuitry 58.

Power supply 60 delivers operating power to components of IMD 32. The power supply 60 may include an externalized battery substantially similar to the externalized battery 108 or 508 described above and a power generation circuit that generates operating power. In some examples, the externalized battery may be rechargeable to allow long term operation. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil (e.g., a wireless power receiver coil) within IMD 32. In other examples, an external inductive power supply may transdermally power IMD 32 whenever electrical stimulation is to occur.

Fig. 9 is a block diagram showing an exemplary configuration of external programmer 24. Although external programmer 24 may be described generally as a handheld computing device, external programmer 24 may be, for example, a notebook computer, a smart phone, or a workstation. As shown in fig. 9, external programmer 24 may include processor circuitry 90, memory 92, user interface 94, telemetry circuitry 96, and power supply 98. The memory 92 may store program instructions that, when executed by the processor circuitry 90, cause the processor circuitry 90 and the external programmer 24 to provide functionality attributed to the external programmer 24 throughout this disclosure.

Generally, external programmer 24 includes any suitable hardware arrangement that performs the techniques attributed to external programmer 24, as well as processor circuitry 90, user interface 94, and telemetry circuitry 96 of external programmer 24, alone or in combination with software and/or firmware. In various examples, external programmer 24 may include one or more processors, such as one or more microprocessors, DSP, ASIC, FPGA, or any other equivalent integrated or discrete logic circuitry, as well as any combination of such components. In various examples, external programmer 24 may also include memory 92, such as RAM, ROM, PROM, EPROM, EEPROM, flash memory, hard disk, CD-ROM, that includes executable instructions for causing one or more processors to perform actions attributed to them. Further, although processor circuitry 90 and telemetry circuitry 96 are described as separate circuitry, in some examples processor circuitry 90 and telemetry circuitry 96 may be functionally integrated. In some examples, processor circuitry 90 and telemetry circuitry 96 and telemetry circuitry 58 correspond to separate hardware units, such as microprocessors, ASIC, DSP, FPGA, or other hardware units. In other examples, processor circuitry 90 and any of telemetry circuitry 96 and telemetry circuitry 58 may correspond to multiple separate hardware units, such as a microprocessor, ASIC, DSP, FPGA, or other hardware unit.

The memory 92 may store program instructions that, when executed by the processor circuitry 90, cause the processor circuitry 90 and the external programmer 24 to provide functionality attributed to the external programmer 24 throughout this disclosure. In some examples, memory 92 may also include program information, such as stimulation programs defining neural stimulation, similar to those stored in memory 56 of IMD 32. Stimulation programs stored in memory 92 may be downloaded into memory 56 of IMD 32.

In some examples, the system includes a user interface 94 that allows the patient 14 to provide input. IMD 32 may respond to patient-provided data from the user interface by altering therapy. For example, the patient 14 may use an external programmer 24 (e.g., a handheld device) to record (by pushing a button) a physiological event of interest. Processor circuitry 53 of IMD 32 may respond by turning on or off therapy, or by adjusting therapy (e.g., stimulation intensity), or by changing the therapy program. With reference to the urology application discussed herein, the patient 14 may push a button on the external programmer 24 (e.g., their smartphone) as the bladder is excreted. For example, this may send a signal to IMD 32 to turn off and enter sleep mode for a pre-programmed period of time based on the drainage characteristics of patient 14.

The user interface 94 may include buttons or a keypad, lights, speakers for voice commands, a display such as a Liquid Crystal (LCD), light Emitting Diode (LED), or Cathode Ray Tube (CRT). In some examples, the display may be a touch screen. As discussed in this disclosure, processor circuitry 90 may present and receive information related to electrical stimulation and resulting therapeutic effects via user interface 94. For example, the processor circuitry 90 may receive patient input via the user interface 94. The input may be in the form of, for example, pressing a button on a keypad or selecting an icon from a touch screen.

The processor circuitry 90 may also present information related to delivering electrical stimulation to the patient 14 or caregiver in the form of an alert to the patient 14 via the user interface 94, as described in more detail below. Although not shown, external programmer 24 may additionally or alternatively include a data or network interface to another computing device to facilitate communication with the other device and presentation of information related to electrical stimulation and therapeutic effects following termination of electrical stimulation via the other device.

Telemetry circuitry 96 supports wireless communication between IMD 32 and external programmer 24 under control of processor circuitry 90. Telemetry circuitry 96 may also be configured to communicate with another computing device via wireless communication techniques, or directly with another computing device through a wired connection. In some examples, telemetry circuitry 96 may be substantially similar to telemetry circuitry 58 of IMD 32 described above, providing wireless communication via a radio frequency or proximal inductive medium. In some examples, telemetry circuitry 96 may include an antenna, which may take a variety of forms, such as an internal antenna or an external antenna.

Examples of local wireless communication techniques that may be used to facilitate communication between programmer 24 and another computing device include those according to 802.11 orRF communication of a specification set, in accordance with, for example, the IrDA standard or other standard or proprietary telemetry protocolInfrared communication of the proposal. In this way, other external devices can communicate with programmer 24 without having to establish a secure wireless connection.

The power supply 98 delivers operating power to the components of the programmer 24. The power supply 98 may include a battery and a power generation circuit for generating operating power. In some examples, the battery may be rechargeable to allow long term operation.

Fig. 10 is a flow chart illustrating an exemplary method of manufacturing a medical device. Although described with respect to IM 100-500, the techniques of FIG. 10 may be performed by IMDs 16 and/or 32 of FIGS. 7 and 8.

The manufacturer may hermetically seal the voltaic cell within a battery housing configured to be implantable within a patient (1002). For example, the manufacturer may hermetically seal the voltaic cell within the battery housing 109 or the battery housing 509 described above.

The manufacturer may externally attach the battery housing to a device housing (1004) configured to be implantable in the patient. For example, the manufacturer may braze and/or weld the battery housing 109 or 509 to the device housing 102 or 302, respectively.

The techniques of this disclosure may be implemented in a wide range of computing devices, medical devices, or any combination thereof. Any of the described units, circuitry, or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as circuitry or elements is intended to highlight different functional aspects and does not necessarily imply that such circuitry or elements must be realized by separate hardware or software components. Rather, functionality associated with one or more circuits or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components.

The present disclosure contemplates a computer-readable storage medium comprising instructions that cause a processor to perform any of the functions and techniques described herein. The computer-readable storage medium may take any of the exemplary forms of volatile, non-volatile, magnetic, optical, or dielectric media, such as RAM, ROM, NVRAM, EEPROM or tangible flash memory. The computer-readable storage medium may be referred to as non-transitory. The server, client computing device, or any other computing device may also include a more portable removable memory type to enable easy data transfer or offline data analysis.

The techniques described in this disclosure, including those attributed to various circuitry and various components, may be implemented at least in part in hardware, software, firmware, or any combination thereof. For example, aspects of the techniques may be implemented within one or more processors including one or more microprocessors, DSP, ASIC, FPGA, or any other equivalent integrated discrete logic circuitry or other processor circuitry, as well as any combination of such components, remote servers, remote client devices, or other devices. The term "processor circuitry" or "processor circuitry" may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry.

Such hardware, software, firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. Furthermore, any of the described units, circuitry, or components may be implemented together or separately as discrete but interoperable logic devices. Depiction of different features as circuitry or elements is intended to highlight different functional aspects and does not necessarily imply that such circuitry or elements must be realized by separate hardware or software components. Rather, functionality associated with one or more circuits or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components. For example, any of the circuitry described herein may include circuitry configured to perform features attributed to that particular circuitry, such as fixed function processor circuitry, programmable processor circuitry, or a combination thereof.

The techniques described in this disclosure may also be embedded or encoded in an article of manufacture that includes a computer-readable medium encoded with instructions. Instructions embedded or encoded in an article of manufacture comprising an encoded computer-readable storage medium may cause one or more programmable processors or other processors to implement one or more of the techniques described herein, such as when the instructions included or encoded in the computer-readable storage medium are executed by the one or more processors. Exemplary computer-readable storage media can include Random Access Memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, a hard disk, a compact disc ROM (CD-ROM), a floppy disk, a magnetic tape cartridge, magnetic media, optical media, or any other computer-readable storage device or tangible computer-readable media. The computer-readable storage medium may also be referred to as a storage device.

In some examples, the computer-readable storage medium includes a non-transitory medium. The term "non-transitory" may indicate that the storage medium is not embodied in a carrier wave or propagated signal. In some examples, a non-transitory storage medium may store data (e.g., in RAM or cache) that may change over time.

The present disclosure includes the following non-limiting examples.

Embodiment 1. A medical device, the medical device comprising: a device housing configured to be implantable within a patient, the device housing comprising an outer surface in contact with a biocompatible electrical insulator; an electronic component housed within the device housing; and; and a battery located outside the device housing and comprising a battery housing configured to be hermetically sealed, wherein the battery is configured to provide power to the electronic component housed within the device housing, wherein the battery housing is configured to be attached to the device housing, wherein the battery housing comprises: an inner surface in contact with the voltaic cell of the battery; and an outer surface in contact with the biocompatible electrical insulator.

Example 2: the medical device of embodiment 1, wherein the inner surface and the outer surface are opposing surfaces of the same battery housing wall.

Example 3: the medical device of embodiment 1 or embodiment 2, wherein the battery housing includes a negative terminal of the battery.

Example 4: the medical device of embodiment 3, further comprising an electrode positioned on an outer surface of the device housing, wherein the electrode is configured to be in electrical contact with tissue or body fluid of the patient, wherein the electronic component comprises stimulation circuitry configured to deliver an electrical stimulation signal, and wherein the electrode is configured to be a source of electrical current or sink for the electrical stimulation signal.

Example 5: the medical device of any one of embodiments 1-4, wherein the battery housing is electrically isolated from the device housing by an electrical insulator.

Example 6: the medical device according to any one of embodiments 1-5, wherein the battery housing is attached to the device housing by an electrical insulator.

Example 7: the medical device of embodiment 5 or embodiment 6, wherein the electrical insulator is a ceramic material.

Example 8: the medical device of any one of embodiments 1-7, wherein the device housing comprises a ceramic material.

Example 9: the medical device according to any one of embodiments 1-8, wherein the battery housing comprises a ceramic material.

Example 10: the medical device according to any one of embodiments 1-9, further comprising an electrode positioned on an outer surface of the device housing, wherein the electrode is configured to be in electrical contact with tissue or body fluid of the patient, and wherein the electrode is electrically isolated from the battery housing by the biocompatible electrical insulator.

Example 11: the medical device according to any one of embodiments 1-10, wherein the biocompatible electrical insulator comprises parylene.

Example 12: a medical device, the medical device comprising: stimulation circuitry configured to generate an electrical stimulation signal; and a device housing configured to be implantable within a patient, wherein the device housing comprises: a first portion housing the stimulation circuitry within a first volume; and a second portion that houses a battery within a second volume, wherein the second portion forms a hermetic seal of the second volume, and wherein the battery is configured to provide power to the stimulation circuitry.

Example 13: the medical device of embodiment 12, wherein the second portion comprises a negative terminal of the battery.

Example 14: the medical device of embodiment 12 or embodiment 13, further comprising an electrode positioned outside the device housing, wherein the electrode is configured to be in electrical contact with tissue or body fluid of the patient and is configured to be a source of current or sink for the electrical stimulation signal.

Example 15: the medical device of any one of embodiments 12-14, wherein the second portion is electrically isolated from the first portion by an electrical insulator.

Example 16: the medical device according to any one of embodiments 12-15, wherein the second portion is attached to the first portion by an electrical insulator, wherein the electrical insulator is a ceramic material.

Example 17: the medical device according to any of embodiments 12-16, wherein the first portion comprises a ceramic material.

Example 18: the medical device according to any of embodiments 12-17, wherein the second portion comprises a ceramic material.

Example 19: the medical device of embodiment 14, wherein the electrode comprises a lead electrode, wherein the biocompatible electrical insulator comprises parylene.

Example 20: a method of manufacturing a medical device, the method comprising: hermetically sealing the voltaic cell within a battery enclosure configured to be implantable within a patient; and externally attaching the battery housing to a device housing configured to be implantable in a patient, wherein the battery housing comprises: an inner surface in contact with the voltaic cell of the battery; and an outer surface exposed to substantially the same environment as the outer surface of the device housing.

Various embodiments have been described herein. Any combination of the described operations or functions is contemplated. These and other embodiments are within the scope of the following claims. Based on the foregoing discussion and illustrations, it has been appreciated that various modifications and alterations of the disclosed embodiments may be made without strictly adhering to the manner of embodiments and applications illustrated and described herein. Such modifications do not depart from the true spirit and scope of the various aspects of the present disclosure, including the aspects set forth in the claims.

Claims

1. A medical device, the medical device comprising:

a device housing configured to be implantable within a patient, the device housing comprising an outer surface in contact with a biocompatible electrical insulator;

an electronic component housed within the device housing; and

a battery located outside of the device housing and comprising a battery housing configured to be hermetically sealed, wherein the battery is configured to provide power to the electronic components housed within the device housing, wherein the battery housing is configured to be attached to the device housing, wherein the battery housing comprises:

An inner surface in contact with a voltaic cell of the battery; and

an outer surface in contact with the biocompatible electrical insulator.

2. The medical device of claim 1, wherein the inner surface and the outer surface are opposing surfaces of the same battery housing wall.

3. The medical device of claim 1, wherein the battery housing includes a negative terminal of the battery.

4. The medical device of claim 1, further comprising an electrode positioned on an outer surface of the device housing, wherein the electrode is configured to be in electrical contact with tissue or body fluid of the patient, wherein the electronic component comprises stimulation circuitry configured to deliver an electrical stimulation signal, and wherein the electrode is configured to be a current source or sink for the electrical stimulation signal.

5. The medical device of claim 1, wherein the battery housing is electrically isolated from the device housing by an electrical insulator.

6. The medical device of claim 1, wherein the battery housing is attached to the device housing by an electrical insulator.

7. The medical device of claim 5, wherein the electrical insulator is a ceramic material.

8. The medical device of claim 1, wherein the device housing comprises a ceramic material.

9. The medical device of claim 1, wherein the battery housing comprises a ceramic material.

10. The medical device of claim 1, further comprising an electrode positioned on an outer surface of the device housing, wherein the electrode is configured to be in electrical contact with tissue or body fluid of the patient, and wherein the electrode is electrically isolated from the battery housing by the biocompatible electrical insulator.

11. The medical device of claim 1, wherein the biocompatible electrical insulator comprises parylene.

12. A medical device, the medical device comprising:

stimulation circuitry configured to generate an electrical stimulation signal; and

a device housing configured to be implantable within a patient,

wherein the device housing comprises:

a first portion housing the stimulation circuitry within a first volume; and

a second portion that houses a battery within a second volume, wherein the second portion forms a hermetic seal of the second volume, and wherein the battery is configured to provide power to the stimulation circuitry.

13. The medical device of claim 12, wherein the second portion comprises a negative terminal of the battery.

14. The medical device of claim 12, further comprising an electrode positioned outside the device housing, wherein the electrode is configured to be in electrical contact with tissue or body fluid of the patient and is configured to be a source of current or sink for the electrical stimulation signal.

15. The medical device of claim 12, wherein the second portion is electrically isolated from the first portion by an electrical insulator.

16. The medical device of claim 12, wherein the second portion is attached to the first portion by an electrical insulator, wherein the electrical insulator is a ceramic material.

17. The medical device of claim 12, wherein the first portion comprises a ceramic material.

18. The medical device of claim 12, wherein the second portion comprises a ceramic material.

19. The medical device of claim 14, wherein the electrode comprises a leaded electrode, wherein the biocompatible electrical insulator comprises parylene.

20. A method of manufacturing a medical device, the method comprising:

Hermetically sealing the voltaic cell within a battery enclosure configured to be implantable within a patient; and

the battery housing is externally attached to a device housing configured to be implantable in a patient,

wherein the battery case includes:

an inner surface in contact with a voltaic cell of the battery; and

an outer surface exposed to substantially the same environment as the outer surface of the device housing.