JP2009537226A - Portable assembly, system, and method for providing functional or therapeutic neural stimulation - Google Patents

Abstract

Neural stimulation assemblies, systems, and methods provide short-term electrical connections by providing electrical connections between muscles or nerves in the body and stimulation generators or recording instruments mounted on or mounted on the surface of the skin. Enabling the provision of clinical treatment or diagnostic tests. The neural stimulation assembly, system, and method may include a carrier and a removable electronic pod that includes a stimulation generating circuit, a power input bay for holding a disposable power source, and user interface components. The assemblies, systems, and methods are adapted to provide coordinated neural stimulation to multiple areas of the body.

Description

(Related application)
This application claims the benefit of US patent application Ser. No. 11 / 595,556 (filed Nov. 10, 2006, entitled “Portable Assemblies, Systems, and Methods for Producing Functional or Therapeutic Neurostimulation”). U.S. Provisional Patent Application No. 60 / 801,315 (filed May 18, 2006, named "Portable Assemblies, Systems, and Methods for Providing Functional Neurotherapeutic Neurostimulation, the benefit of these"). Incorporated herein by reference.

  This application is also claimed in US patent application Ser. No. 11 / 545,339 (filed Oct. 10, 2006, entitled “Portable Percutaneous Assemblies, Systems, and Methods for Providing Highly Selected Human Tulsion”). This application is hereby incorporated by reference.

  This application is also claimed in US patent application Ser. No. 11 / 545,336 (filed Oct. 10, 2006, entitled “Portable Percutaneous Assemblies, Systems, and Methods for Providing Highly Selective Functors”). This application is hereby incorporated by reference.

(Technical field)
The present invention relates to assemblies, systems, and methods for providing neural stimulation to tissue.

  Neural stimulation, ie neuromuscular stimulation (neural and / or muscular electrical excitation for direct muscle contraction) and neuroregulatory stimulation (neural to indirectly affect the stability and ability of the physiological system, Mostly electrical stimulation of afferent nerves) and brain stimulation (stimulation of the brain or other central nervous system tissue) can provide functional and / or therapeutic outcomes. While existing systems and methods can provide significant benefits to individuals in need of neural stimulation, many quality of life issues still remain. For example, existing systems cannot perform in a manner that performs a single, dedicated stimulation function and provides coordinated stimulation to multiple areas of the body. Furthermore, these controllers are relatively large from today's standards, and are difficult to operate and carry.

  There are external and implantable devices for providing neural stimulation in various therapeutic and functional recovery indicators. These neurostimulators can provide therapeutic therapy to individual parts of the body. The operation of these devices typically involves the use of either electrodes placed on the external surface of the skin, vaginal or intraanal electrodes, and / or surgically implanted electrodes. In the case of an external nerve stimulator, a percutaneous lead having electrodes is coupled to the external stimulator and a lead implanted in the body for delivering electrical stimulation to a selected portion of the patient's body.

  Existing systems typically use line power or battery power to operate the stimulation network and generate stimulation pulses. Power is generally uncontrollable, which means that there is no proper user control (which may or may not be used) and the system will operate as long as the system is connected to line power or a battery will operate the system. This means that stimulation pulses can be generated as long as they have sufficient capacity to do, both can be days, weeks, or even months.

  When batteries are used in existing systems, they are incidental to the stimulation regime and are replaced at the end of their battery life. Batteries are included to provide only a power source, and the choice of battery is usually a compromise between the physical size of the battery and the longest possible battery life, i.e. the battery is usually as small as possible, Provide the longest possible battery life. Existing systems and methods provide the ability to provide power and user control, while many limitations and problems still exist.

  Systems and methods for providing coordinated stimulation to multiple areas of the body are not practical with known stimulation devices. A number of individual stimulators can be used to provide stimulation to multiple areas of the body, but lack effective systems and methods that can regulate stimulation to multiple areas of the entire body .

  Systems and methods for providing neural stimulation not only address specific prosthetic or therapeutic difficulties, but also control power to the stimulation network to provide coordinated stimulation to multiple areas of the body. It is time to address the quality of life of individuals who need nerve stimulation, including the ability to provide.

  The present invention provides improved assemblies, systems, and methods for providing supplemental or therapeutic neural stimulation.

  One aspect of the present invention is a portable, translucent, providing electrical connection between muscles or nerves in the body and a stimulus generator or recording instrument that is temporarily attached to the surface of the skin or mounted externally. Skin or surface mounted neural stimulation assemblies, systems and methods are provided.

  The assembly, system, and method may be connected, in use, to an electrode that is implanted below the skin surface by a percutaneous lead, or to a conventional surface mounted electrode, As well as in the target tissue region. The neural stimulation assembly, system, and method apply a highly selective pattern of neural stimulation only to a target region to achieve one or more highly selective therapeutic and / or diagnostic results. The pattern can vary depending on the desired therapeutic and / or diagnostic goals. Indicators are predicted functionalities, for example by highly selective treatment of pain or muscle dysfunction and / or highly selective promotion of tissue or bone healing and / or permanently implanted devices in the future A highly selective diagnosis of the effect of electrical stimulation therapy can be included. In addition, the controller interface from the user to the neural stimulation assembly, system, and method may be wireless or manually entered via the user interface.

  The neural stimulation assembly, system, and method include a skin-mounted patch or carrier. Instead of being worn on the skin, the carrier can be easily loaded, for example by the use of adhesives, without discomfort and without affecting the body image on the individual's arms, legs or torso, for example. The batch or carrier can also be carried by the patient or can be fixed to clothing, a bed, or a mobile device that allows patient mobility.

  The carrier carries a removable and replaceable electronic pod that generates the desired electrical current pattern. The pod contains a microprocessor-based programmable circuit that generates stimulation current, time or ordered stimulation pulses, monitors system status, and records and monitors usage. The electronic pod may be configured to accept wireless RF-based commands for both wireless programming and wireless patient management, if desired.

  The electronic pod may also include an electrode connection region to physically or electrically connect a percutaneous electrode lead to the circuitry of the electronic pod or to an electrode mounted on the surface. .

  The electronic pod further includes a power input bay to receive a small lightweight disposable power supply that can be released and replaced as prescribed. The power supply supplies power to the electronic pod.

  In a general regime prescribed using the neural stimulation assembly, system, and method, an individual periodically removes and discards the power source (eg, approximately once a day, once a week, or necessary It may be instructed to replace it with a new power source. This setting simplifies meeting the power demand of the electronic pod and facilitates prescribing treatments for different time periods (eg, applying stimuli every 8 hours, daily, or weekly). Thereby, the use of the neural stimulation assembly, system, and method is equivalent to the usual usual drug treatment regime, and the power source is exchanged at a prescription frequency similar to that of an individual administering the drug treatment regime in tablets. .

  The power input bay can also serve as a communication interface. The communication interface may be connected to a bonded communication interface on the external device, or may have a wireless interface with the external device. Through this link, the caregiver or clinician can individually program the operation of a given electronic pod. If necessary, the caregiver or clinician can adjust various stimulation parameters in real time.

  The assembly, system, and method allow for many different outcomes. For example, (i) electrical to muscles (or their debilitating nerves) whose will control has been compromised due to extinction or injury to the central nervous system (eg, leg trauma, stroke, central nervous system disease, etc.) Acute pain relief through treatment of pain or muscle dysfunction by applying stimuli and / or (ii) temporary damage to function due to disease or injury to maintain muscle strength, massive peripheral blood flow, etc. Maintaining bone function through temporary stimulation and preventing disuse atrophy, and / or (iii) small in bone or tissue to support or promote healing such as bone fusion, tissue regrowth, etc. Pain via application of neural stimulation to enhance tissue and bone regeneration through the provision of DC current (or ultra-long wave AC current) and / or to provide (iv) neuromodulatory or inhibitory effects Or treatment of other conditions, and / or (v) post-operative reconditioning to enhance muscle function and promote post-operative muscle strength recovery, and / or (vi) increase venous return of blood, for example Effectiveness of anti-thrombotic therapy by stimulation of leg muscles for and / or (vii) treatment of osteoporosis by stimulation of muscle circulation and / or (viii) more permanent implant implantation For example, to assess whether a person with C5-6 limb paralysis has an innervated triceps that can respond to treatment with electrical stimulation. Time recording and / or (ix) short-term recording of biopotential signals generated in the body, and / or (x) walking or Results for the functional benefits of the recovery, such as the failure or loss of limb function.

  Another aspect of the present invention provides an assembly, system and method for providing neural stimulation, comprising at least one electrode, a carrier sized and configured to be worn by a user, and the carrier An electronic pod that is detachably mounted on-board, including a network configured to generate a stimulation pulse on the electrode, and the electronic pod electrically coupled to the network An onboard power input bay comprising a power input bay sized and configured to accept a disposable power source.

  The disposable power source includes circuitry that may include non-volatile memory to electronically store information about the power source. The electronic pod circuitry may also include a non-volatile memory to electronically store information regarding the power source. The electronically stored information can include, for example, power usage data (eg, usage history), unique power identification, and power capacity.

  The assembly, system, and method may include a supply of power provided in a storage container that includes one or more disposable power supplies for a daily or prescribed power exchange regime period. The organizing container can take the form of a daily tablet case that includes one or more compartments to hold one or more disposable power supplies for a daily or prescribed power exchange regime period.

  Further, the electronic pod may include a visual output such as a display unit mounted on the electronic pod. The visual output can also be provided by an illumination source that illuminates at least a portion of the electronic pod.

  Other features and advantages of the present invention are described in the following specification and attached drawings.

FIG. 1 is a perspective view of a nerve stimulation assembly that provides an electrical connection between muscles or nerves in the body and a stimulation generator that is temporarily attached to or mounted on the surface of the skin. FIG. 2 is a diagram of the nerve stimulation assembly shown in FIG. 1 temporarily worn on the external skin surface of the arm. FIG. 3A is an exploded side view of an alternative embodiment of the nerve stimulation assembly shown in FIG. 1, showing its connection to a percutaneous lead leading to an electrode implanted below the skin surface of the target tissue region. FIG. 3B is an exploded side view of an alternative embodiment of the neural stimulation assembly shown in FIG. 1, showing its connection to a percutaneous lead leading to an electrode implanted below the skin surface of the target tissue region. FIG. 3C is a perspective view of an alternative embodiment of the neural stimulation assembly shown in FIG. 1, showing an alternative configuration for coupling the neural stimulation assembly to a percutaneous lead. FIG. 3D is a perspective view of an alternative embodiment of the neural stimulation assembly shown in FIG. 1, showing an alternative configuration for coupling the neural stimulation assembly to a percutaneous lead. FIG. 4 is a bottom view of the nerve stimulation assembly shown in FIG. 1 and shows the adhesive region including the return electrode. FIG. 5 is a perspective view of a nerve stimulation assembly of the type shown in FIG. 1, showing a second return electrode connected to the stimulation assembly. FIG. 6 is a bottom view of a neuromuscular stimulation system assembly of the type shown in FIG. 1, showing an adhesive region that includes both an active electrode portion and a return electrode portion. FIG. 7 is a perspective view of a nerve stimulation assembly of the type shown in FIG. 1 coupled to an external programming device. FIG. 8 is a perspective view of a nerve stimulation assembly of the type shown in FIG. 1 associated with external programming and control equipment that relies on a wireless communication link. FIG. 9 is a perspective view with partial cutaway showing the power supply housing and internal and external components. FIG. 10A is a perspective view of the electronic pod shown in FIG. 1 and shows the components of the electronic pod, including user interface components. FIG. 10B is a perspective view of the electronic pod shown in FIG. 10A, showing the light emitting or illumination features. FIG. 11 is a block diagram of a circuit that can be utilized by the nerve stimulation assembly shown in FIG. FIG. 12 is a graphical representation of the desired biphasic stimulation pulse output of a neural stimulation assembly for use with the system shown in FIG. FIG. 13 illustrates the use of an electrode introducer to implant electrodes percutaneously into a target tissue region and connect to a nerve stimulation assembly as shown in FIG. FIG. 14 illustrates the use of an electrode introducer to implant electrodes percutaneously into a target tissue region and connect to a nerve stimulation assembly as shown in FIG. FIG. 15 illustrates the use of an electrode introducer to implant electrodes percutaneously into a target tissue region and connect to a nerve stimulation assembly as shown in FIG. FIG. 16 shows an electrode introducer having a remotely deflectable distal needle region to guide the electrode percutaneously into a desired implantation position prior to connection to a nerve stimulation assembly as shown in FIG. Show. FIG. 17 shows an electrode introducer having a remotely deflectable distal needle region for percutaneously guiding the electrode into a desired implantation position prior to connection to a nerve stimulation assembly as shown in FIG. Show. FIG. 18 illustrates an electrode introducer having a remotely deflectable distal needle region to guide the electrode percutaneously into a desired implantation position prior to connection to a nerve stimulation assembly as shown in FIG. Show. FIG. 19A shows a neurostimulation therapy with the insertion of a new power supply, just as an individual taking a prescription replacement power supply and an individual taking a drug treatment regime “administers” the drug by taking a tablet. FIG. 2 is a perspective view of a nerve stimulation system comprising a nerve stimulation assembly of the type shown in FIG. 1 in connection with instructions for using the nerve stimulation assembly, including power supply. FIG. 19B is a perspective view of a power tablet case, or organizing container, to assist patient compliance with a prescribed neural stimulation regime. FIG. 19C is a plan view of a kit for packaging a nerve stimulation assembly and a tablet case with instructions for use as shown in FIGS. 19A and 19B. FIG. 19D is a plan view of an alternative kit similar to that shown in FIG. 19C, which packages a neural stimulation assembly, one or more leads, and a tablet case with instructions for use. FIG. 20 is an anatomical view showing an alternative configuration of a neural stimulation assembly and system, which includes a harnessed multi-channel stimulation assembly that can provide coordinated neural stimulation to multiple areas of the body. . FIG. 21 is an anatomical view of the system shown in FIG. 20, showing a harnessed multi-channel stimulation assembly configured to be secured to a moveable table next to a patient. FIG. 22 is an anatomical view showing a further alternative configuration of the nerve stimulation assembly and system, the system including a master nerve stimulation assembly and one or more slave nerve stimulation assemblies, where the master assembly includes a number of slave nerves. Emphasis control of the stimulation assembly can be provided and the system can provide coordinated neural stimulation to multiple areas of the body.

  The present invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims rather than in the preceding specific description. Accordingly, all embodiments that come within the meaning and range of equivalency of the claims are encompassed by the claims.

  Various aspects of the invention are described in connection with providing neural stimulation for prosthetic or therapeutic purposes. This is because the features and advantages resulting from the present invention are well suited for this purpose. In addition, it should be understood that various aspects of the invention can be applied to accomplish other objectives.

(I. Outline of nerve stimulation assembly)
FIG. 1 shows a neural stimulation assembly 10. As shown in FIG. 2, the neural stimulation assembly 10 is sized and configured to be conveniently worn temporarily during use. “Worn” means that the assembly 10 may be removably attached to the skin or carried by a patient (ie, a user), or the patient's clothing, bed, or patient movement. It means that it may be fixed to a movable device that allows sex. “Temporarily” means that the presence of the nerve stimulation assembly 10 is well tolerated without discomfort over a period of several hours to one or two months, after which the nerve stimulation assembly 10 is removed and discarded. obtain. During the period of use, the nerve stimulation assembly 10 may be removed and reattached for hygiene maintenance. Desirably, the assembly 10 is constructed in a manner that meets at least the IPX1 standard for water intrusion. The assembly 10 may be constructed in a manner that meets higher standards, such as to allow a patient to wear the nerve stimulation assembly 10 during a shower.

  As shown in FIGS. 3A and 3B, the nerve stimulation assembly 10 is releasably coupled in use to a percutaneous lead 12 having an electrode 14 that is implanted below the skin surface in the target tissue region. The tissue region is targeted prior to implantation of the electrode 14 due to their muscle and / or neuromorphology in terms of desired therapeutic and / or functional and / or diagnostic purposes.

  In use, the neural stimulation assembly 10 generates a current pattern, distributes it to the electrode 14 via the percutaneous lead 12, and returns to the return electrode. In this manner, the neural stimulation assembly 10 applies a highly selective pattern of neural stimulation only to the target area to achieve one or more highly selective therapeutic and / or diagnostic results. As described in more detail below, the input / stimulation parameters can vary depending on the desired therapeutic and / or diagnostic purposes. For example, the outcome may be a highly selective treatment of pain or muscle dysfunction, and / or a highly selective promotion of tissue or bone healing, and / or a highly selective effectiveness of expected functional electrical stimulation therapy. Diagnostics can be included.

(II. Desired technical features)
The neural stimulation assembly 10 can incorporate various technical features to enhance its usefulness and are described below.

(A. Carrier)
In its most basic form (see FIGS. 1, 3A and 3B), the nerve stimulation assembly 10 comprises a disposable patch or carrier 16. The carrier 16 is desirably sized and configured as a small, lightweight and flexible assembly made of, for example, an inert, formed or machined plastic or metal material.

  In an exemplary embodiment, the carrier 16 is about 2 to 4 inches in diameter, weighs for example about 5 grams, and may include a number of wings 17 to increase the mounting surface area. With this size, the carrier 16 can be easily mounted in an appearance acceptable manner (shown in FIG. 2) without discomfort. The flexible carrier material and shape can position the nerve stimulation assembly 10 on a curved surface of the body, such as the arms, shoulders, legs, abdomen, and back.

(B. Adhesion area)
A surface area (see FIGS. 1, 3A, and 3B) of at least a portion of the carrier 16 that is probably larger than the lower surface of the carrier includes a disposable adhesive region or patch 18. The adhesive region 18 may be an integral component of the carrier 16 (shown in 3A) or a separate component (shown in 3B). The function of the adhesive area 18 is to temporarily fix the carrier 16 to the external skin surface during use. For example, an inert conventional adhesive or adhesive tape can be used. Desirably, the skin adhesion area contains a bacteriostatic filler that prevents skin irritation or superficial infection that can lead to premature removal.

  Adhesive region 18 can also include an electrically conductive material. In this setting, the adhesive region 18 can function or include a surface return electrode 19 so that the monopolar electrode 14 can be embedded if desired. The surface return electrode 19 reduces the possible infection of the surface electrode 19 to the patient, does not require additional special surgery for installation, and the surface electrode provides a larger surface than the needle electrode, so the needle More desirable than a mold return electrode. The surface return electrode 19 may also have adhesive properties that help maintain the nerve stimulation assembly 10 on the skin surface.

  When the adhesive region 18 including the surface return electrode 19 is an integral part or a separate component of the carrier 16, the surface electrode is used to provide an electrical connection to an electronic pod 20 that is coupled to or mounted on the carrier 16. , Electrically coupled to the carrier (described below). In the exemplary embodiment, return electrode 19 is approximately 1 to 3 inches in diameter. This size range provides a surface area that is large enough that no sensory or motor stimulation occurs at the return electrode position. The return electrode 19 can also function as an active electrode when used as a stimulation system mounted on the surface. In this configuration, the second return electrode 19 ′ is anchored to the stimulation system (see FIG. 5) or incorporated within a concentric ring, such as the adhesive region 18 (see FIG. 6).

(C. Electronic pod)
The carrier 16 further carries an electronic pod 20 that can generate a desired current pattern and communicate with an external programming system or controller 46.

  As shown in FIG. 3A, the electronic pod 20 can comprise a component or assembly, such as a molded plastic component or assembly that can be removably coupled to the carrier 16. In an alternative embodiment, the electronic pod 20 may be inserted into and removed from the electronic bay 22 on the carrier 16 (see FIG. 3B). Having an electronic pod 20 that can be disconnected from the carrier 16 may be desirable if the need to replace the carrier 16 or the electronic pod 20 during the course of treatment is essential. For example, if the carrier 16 is replaced without replacing the electronic pod 20, the expected period of use of the nerve stimulation assembly 10 is sufficiently long, and deterioration of the adhesive force of the adhesive region 18 is expected. May include a return electrode 19 and may suffer from degradation of adhesion and / or electrical conductivity with use. Alternatively, the electronic pod 20 can include an integral securing portion of the carrier 16.

  Regardless of whether the electronic pod 20 is removable from the carrier 16 (see FIGS. 3A, 3B, and 10A), the pod 20 generates a stimulation waveform, timing, or continuous stimulation pulses, records and monitors usage, It houses a microprocessor-based (microcontroller) network 24 that can monitor system status and communicate directly to the clinician or indirectly through the use of an external programmer or controller. As a representative example, the stimulation is desirably a biphasic waveform (net DC current less than 10 microAmp) that can be adjusted from about 0 mA to about 20 mA based on the electrode type and the type of tissue being stimulated, and about It has a pulse duration adjustable from less than 5 microseconds up to more than 500 microseconds and a frequency from about 10 Hz to about 150 Hz. Many muscle stimulation applications are in the 10 Hz to about 20 Hz region, and pain management may use higher frequencies. The stimulation current (amplitude) may be user selectable and the pulse duration may be limited to be selectable by the clinician.

  The network 24 preferably includes a non-volatile memory, such as a flash memory device or an EEPROM memory chip, for mounting built-in programmable code 26. Code 26 represents a pre-programmed rule or algorithm according to which stimulus timing and command signals are generated. The network 24 can be mounted in a single location on the pod 20 or at various locations and may be fabricated on a flexible or flex-rigid printed circuit board using ultra-high density technology.

(D. Lead connector)
As shown in FIGS. 1, 3A, and 3B, the electronic pod 20 also includes one or more lead connectors 27. The function of the lead connector 27 is to physically and electrically connect the distal end of the percutaneous electrode lead 12 to the network 24 of the electronic pod 20 (shown in FIGS. 3A and 3B). If multiple connectors 27 are used, each lead connector 27 can distribute a current pattern within the channel, that is, each electrode 14 applies a highly selective stimulation pattern through the multiple electrodes 14. So that it can be done. One or more channels may be provided.

  The lead connector 27 can be provided / constructed in various ways. In the illustrative embodiment, the lead connector 27 includes a pigtail cable 28 that extends out of the electronic pod 20 and terminates at the connector 29. Similarly, it should be understood that the pigtail cable can extend out of the carrier 16 (see FIG. 3C). It should also be understood that the connector 29 may be integral with the electronic pod 20 or carrier 16 as well, that is, the pigtail cable 28 may be absent. Such an integral connector may be joined to the insulating lead 12 that does not include the joining connector 29 '(as described below). The integral connector 29 on the electronic pod 20 or carrier 16 terminates in an insulating lead 12 and is electrically connected to the lead (see FIG. 3D).

  FIG. 3A shows each connector 29 sized and configured to slidably receive a mating connector 29 ′ coupled to lead 12 or second return electrode 19 ′. Both connectors 29 and 29 'may be touch proof connectors to help maintain a consistent and reliable electrical connection. Each lead connector 27 may be labeled with a number or other indicia to record the channel of the electronic network 24 that is coupled to each channel.

  Alternative embodiments are possible. The connection of the electrode lead 12 to the electronic pod 20 or the carrier 16 can be achieved by a rocking motion, a button or lever arm, or an Allen drive, eg, pressed, slid, pulled or twisted.

  Desirably (see FIG. 3A), the electronic pod 20 can be removed and replaced using a snap fit of the electronic pod 20 to or from the carrier 16. Alternatively, the electronic pod 20 can be removed and replaced using a snap fit of the electronic pod 20 from or into the electronic bay 22 of the carrier 16 (see FIG. 3B). An electrical connection region or contact 62 on the pod 20 is used to connect the network 24 on the pod 20 to a return electrode 19 positioned below or integrally with the carrier 16. 16 or electrically connected to a connecting region or contact portion 63 to be fitted in the electronic bay 22. A set of mating connection areas or contacts 62, 63 may be used (shown in FIG. 3B), or more than one set of mating connection areas or contacts 62, 63 may be used ( (Illustrated in FIG. 3A). More than one set may help to eliminate any rotational movement between the carrier 16 and the electronic pod 20.

(E. Power input / communication bay)
Referring again to FIGS. 3A and 3B, the electronic pod 20 further includes a power input bay 30. One function of the power input bay 30 is to receive a replaceable and (desirably) disposable power supply 32 releasably. The power source 32 supplies power to the electronic pod 20. The power supply 32 may incorporate a snap-fit mechanism for securing the power supply in the power input bay 30.

  In a typical regime prescribed using the neural stimulation assembly 10, an individual would be instructed to remove and discard the power supply 32 approximately once a day and replace it with a new power supply 32. . While this setting allows for easy prescribing of treatments for different periods of time (eg, removing and replacing power every other day or weekly to provide stimulation in prescribed intermittent units) Meeting the power demand of the electronic pod 20 is simplified. Thereby, the use of the neural stimulation assembly 10 is equivalent to the usual usual medication regime, and the power supply 32 is replaced as often as the individual administers the medication in tablets. A power source 32 may be provided in the outer sheath housing 34 to facilitate installation and removal.

  The power input bay 30 can also function as a communication interface. As shown in FIG. 7, in the absence of a power supply 32, the bay 30 can be used to plug the cable 58 into an external programming device 46 or computer. This will also be described later. This allows linking of the external programming device 46 or computer and the electronic pod 20. Through this link, information and programming inputs can be exchanged and data can be downloaded from the electronic pod 20.

  In this manner, the nerve stimulation assembly 10 allows a caregiver or clinician to individually program the operation of a given electronic pod 20 as permitted by the built-in programmable code 26. Of course, instead of using a cable interface, as shown, wireless link 59 (eg, magnetically coupled RF, infrared, or RF) allows electronic pod 20 to communicate with external programming device 46 or a computer. It should be understood that (see FIG. 8).

(F. Power supply)
The disposable power source 32 can be described as a built-in, limited-life power source. The disposable power source 32 includes a housing 34 that includes one or more batteries 35, such as an alkaline, lithium, or silver oxide battery, a network 36, and a contact portion 37 for supplying power to the electronic pod 20. (See FIG. 9).

  The circuitry 36 of the disposable power supply 32 may be used to electronically store information about the power supply. The network 36 may include a non-volatile memory 31 for storing power supply information. The capacity of the power supply 32 may be preserved, for example, the power supply may identify itself as a 1 hour power supply, a 6 hour power supply, or a 24 hour power supply. The network 36 can also identify each unit (e.g., to provide a unique identification such as a serial number) and / or the total power usage (service time) provided so far by the power source. ) Can be identified electronically.

  The replacement of the power source 32 is a way for the patient to initiate another session of use or another episode of treatment. The use / treatment session / episode may be interrupted by removing the power supply 32, and stimulation will resume when the same power supply is reinserted. However, the total duration of stimulation from one power supply 32 is still limited to the values defined for the power supply, such as 8 hours of use, or 12 hours or 24 hours of use. Battery 35 and electrical component 36 are inaccessible for battery replacement. The battery 35 is secured in a housing 34, such as a molded plastic housing, to help handle the power source. The housing also prevents the use of a power source that is not for the nerve stimulation assembly 10. The housing may include multiple elements and may be made inaccessible by sonic welding, gluing, or other permanent fastening methods that secure the housing together. Even if the battery 35 is replaced, the network 36 of the power source 32 prevents its reuse.

  The usage instructions 56 are intended to be provided by a clinician or caregiver or physician who prescribes the release or replacement of the disposable power supply 32 according to a prescribed power supply replacement regime. The prescribed power supply replacement regime includes exchanging the disposable power source 32 on a prescribed, repeat basis, similar to the administration of “tablets” under the prescribed tablet-based drug treatment regime.

  It is intended to provide a supply of disposable power sources 32 for administration according to a prescribed power exchange regime, i.e., use or treatment regime, whereby each power source provides for delivery of neural stimulation. Provide “dosing” of power for the network. Using a prescribed power exchange regime (similar to a prescribed tablet-based medication regimen), the caregiver / clinician / physician can repeatedly or periodically (similar to taking the dosage in tablets) The disposable power supply 32 is removed and replaced at the base, instructing the patient to administer a dose of power to the network, so that the network can generate a dose of neural stimulation. In this way, the prescribed power supply replacement regime has the effect or characteristics of a prescribed tablet-based drug treatment regime, rather than a battery time-out after a lifetime.

(G. User interface)
The electronic pod 20 shown in FIGS. 10A and 10B desirably includes one or more features that provide an interface mechanism to the patient and / or clinician. Interface features allow input and output of neural stimulation assembly information such as stimulation regime parameters and system status, and the interface may be manual, audio, visual, or a combination. For example, the electronic pod 20 may include control means 38, such as two button controls 38, so that the patient can control the stimulation amplitude setting or some other stimulation intensity adjustment. The electronic pod 20 includes one or more recessed buttons 39, eg, paper clips, for providing control to the clinician so that the clinician can access settings that can be controlled, such as stimulation pulse duration and / or stimulation frequency. An access switch may be included.

  The specific setting level can be displayed using a display 40 such as an LCD or LED display, for example, to visually identify the setting level to the patient and then the patient can contact the physician for confirmation. Allows setting to be recorded in the presented treatment diary. The operating mode and stimulation parameters may be entered manually using the control means 38 and / or 39 and may be easily interpreted via visual output or feedback display 40. In one embodiment, the set level is a combination of pulse duration and amplitude, the details of which are unknown to the patient. Further, the display unit 40 may provide a data reading function to the clinician. For example, the display 40 may provide information such as the total duration of the provided stimulus, the average or median stimulus level selected by the patient, and possibly the total number of power sources used.

  The display unit 40 may provide status information such as a power status or a system status. In a power situation, the stimulation assembly 10 may indicate that the power source 32 located in the power input bay 30 has a limited power balance or that the power source provided its maximum amount of power. . In a system situation, the stimulation assembly 10 has either the electronic pod 20 not properly connected to the carrier 16 (or is not located in the electronic bay 22), or an electrical connection to the lead 12 or return electrode 19, for example. May indicate that is not functioning.

  In addition to or instead of the visual feedback display 40, visual output or feedback may also be provided by a portion of an electronic pod such as the illuminated electronic pod 20 or the pod cover 21. The pod cover 21 is a material, such as translucent, that can allow an illumination source 42 such as one or more LEDs to provide a “light emitting” or “irradiated” appearance, as shown in FIG. 10B. Materials may be included. The irradiation source 42 is connected to the network 24 in the electronic pod 20. The status information can be provided visually to the user, for example by using various blinking or pulse configurations, illumination brightness, color changes, or any combination. Similar to the display unit 40, the status information may include a power status and a system status.

(III. Typical neural stimulation assembly network)
FIG. 11 shows an embodiment of a block diagram circuit 90 for a nerve stimulation assembly 10 that takes into account the desired technical features of the nerve stimulation assembly design described above. Circuits 90 can be grouped into functional blocks that generally correspond to the association and interconnection of electronic components.

  In FIG. 11, the following six functional blocks are shown. (A) Microprocessor network 24, (B) power supply 32, (C) VCC power supply 92, (D) VHH power supply 94, (E) stimulus output stage 96, and (F) output multiplexer 98.

  A description of the relevant functions and possible major components and circuits for each of these blocks is described below.

(A. Microcontroller network)
The microcontroller network 24 may be responsible for the following functions:
(1) Timing and sequencing of the functions of many electronic pods 20, including generation of stimulation pulses and quantification of power usage.
(2) A / D converter for measuring output pulse, power supply voltage, and VHH voltage,
(3) D / A converter capable of setting pulse amplitude,
(4) Control over the display 40 and / or illumination source 42 (5) and / or provide a time signal to the microprocessor network from the initial power supply of the electronic pod 20 for approximately 21 days without the presence of the power supply 32 Control over real-time clock to match.

  The use of a microcontroller-based network incorporating flash programmable memory allows the neurostimulator operating software and the stimulation parameters and settings to be stored in non-volatile memory. Even if it is discharged or removed, it remains safely stored). The nonvolatile memory is also used for storing usage history information. The VCC power supply 92 must support the power requirements of the microcontroller network 24 during any flash memory erase and program operation.

  Although the microcontroller network 24 may be a single component, the firmware is developed as many separate modules that handle specific requirements and hardware peripherals. The functions and routines of these software modules are executed in sequence, but the execution of these modules is timed and coordinated so that they can function effectively and simultaneously. The operation of the microcontroller directly associated with a given hardware functional block will be described along with that block.

  The components of the microcontroller circuit may include:

  (1) Single chip microcontroller 25. This component may be a member of the Texas Instruments MSP430 family of flash programmable, low power consumption, highly integrated mixed signal microcontrollers. Promising family members used include MSP430F1610, MSP430F1611, MSP430F1612, MSP430F168, and MSP430F169. Each of these components includes a number of internal peripherals, a low power internal organization that allows unused peripherals to be configured with minimal power consumption, and a microcontroller that suspends most functions. And an instruction set that supports a large number of operations separated by sleep intervals.

  (2) A small crystal unit for establishing accurate timing of the microcontroller. This may be a 32.768 KHz quartz crystal.

  (3) Various power decoupling and analog signal filtering capacitors.

(B. Power supply)
The power supply 32 (including the operation of the associated microcontroller network 24) may be responsible for the following functions:

(1) Monitor battery voltage,
(2) When the power supply 32 voltage becomes extremely low, the stimulation is temporarily suspended.
(3) stop stimulation when the power source is used for a predetermined time within an acceptable range, eg 24 hours or any time prescribed by the clinician,
(4) Prevent delivery of excess current from the power supply 32 (with single fault tolerance), and (5) Power the remaining circuitry of the neural stimulation assembly, eg, VCC and VHH power supplies.

  In one embodiment, power management control is generally included within the electronic pod 20. As described above, the network 24 includes non-volatile memory adapted to store power usage information written and read by the electronic pod 20.

  (1) The electronic pod 20 and associated microcontroller circuitry 24 communicate with the power supply 32 and periodically update usage data such as the length of time the power supply has been used or the total number of pulses. The network 24 is also adapted to read and write power usage data to the non-volatile memory 31 in the power source 32. The electronic pod 20 then stops generating and applying stimuli after the power source 32 has been used for its prescription time, or if the power source fails prematurely.

  (2) Each power supply may be uniquely identified by including information in the nonvolatile memory 31.

  In an alternative embodiment, power management controls are included with the power supply 32 and require minimal assistance from the electronic pod 20.

  (1) The power source is isolated from all circuitry through MOSFET switches that require active closure by circuitry on the power source.

  (2) The power supply network includes a resettable polymer-based fuse, and the voltage drop across the fuse is read by the power supply network as an indicator of current consumption.

  (3) A low cost microcontroller may be included to keep track of the time that the power supply is providing power.

(C. VCC power supply)
The VCC power supply 92 is generally responsible for the following functions.

  (1) Regardless of changes in power supply voltage, a regulated DC voltage, typically about 1.0 VDC to about 3.3 VDC, is provided to the microcontroller network 24 and other circuitry.

  The VCC power supply may include a low dropout linear voltage regulator with low power consumption, for example, Microchip NCP1700T-3302, Maxim Semiconductor MAX1725, or Texas Instruments TPS79730. The VCC power supply may also include a charge pump or switching mode power supply regulator, such as Texas Instrument TPS60124 or Maxim MAX679.

(D. VHH power supply)
The VHH power supply 94 is generally responsible for the following functions.

  (1) Stimulus output stage 96 and use a high enough programmable DC voltage to drive the required cathode phase current due to voltage drop across the electrode circuit and stimulator stage and possibly output coupling capacitor If so, provided to multiplexer 98. VHH is typically about 12 VDC to about 35 VDC.

  The components of the VHH power supply may include:

  (1) Inductor-based (flyback topology) switch mode power supply with low power consumption, such as Texas Instruments TPS61045, Texas Instruments TPS61041, Linear Technology LT1615, or Linear Technology LT3459.

  (2) The microcontroller circuit 24 monitors VHH to optimize VHH for VHH power supply failure, system failure detection, and indicated electrode circuit impedance.

(E. Stimulus output stage)
The stimulus output stage 96 is generally involved in the following functions.

  (1) Generate a biphasic stimulation current that is identified with the selected cathode phase amplitude, pulse width, and frequency. The restoration phase may incorporate a maximum current limit and there may be a delay time (generally a fixed delay) between the cathode phase and the restoration phase (see FIG. 12). Typical current (cathode phase) varies from about 0.5 mA to about 20 mA based on the electrode configuration and the nature of the tissue being stimulated. The electrode circuit impedance can vary depending on the electrode and application, but is likely to be less than 2,000 ohms and greater than 100 ohms over a range of electrode types.

Two alternative configurations of the stimulus output stage are described. In the first configuration,
(1) The cathode phase current through the electrode circuit is high gain (HFE) with emitter degeneration shunted by four switching shunt resistors (switching lines AMP0-AMP3) to form a controlled current sink. Established by NPN transistor.

  (2) The microcontroller circuit 24 checks the correct operation of the output coupling capacitor, detects system failures, optimizes VHH for the indicated electrode circuit impedance, ie measures the electrode circuit impedance. In order to do this, the cathode voltage is monitored.

In a second alternative configuration,
(1) A low threshold N-channel MOSFET driven by an operational amplifier having a fast enable / disable function to provide a current sink for low quiescent current.

  (2) A precision voltage reference of approximately 2.048V for both the microcontroller circuit external reference and the current sink reference.

  (3) Four switching shunt resistors (switching lines AMP0-AMP3) for forming a controlled current sink.

  (4) The microcontroller circuit 24 checks the correct operation of the output coupling capacitor, detects system failures, optimizes VHH for the indicated electrode circuit impedance, i.e. measures the electrode circuit impedance. In order to do this, the cathode voltage is monitored.

  In either configuration, the switching resistor can be replaced by a DAC when available as an on-chip peripheral in the microcontroller. In either configuration, the start and end of the cathode phase current is timed by the microcontroller.

(F. Output multiplexer)
Output multiplexer 98 is required only when more than one electrode circuit is required. The output multiplexer is responsible for routing the anode and cathode connections of the stimulation output stage 96 to the appropriate electrode, namely electrode 14, return electrode 19 or both.

  A typical output multiplexer configuration includes:

(1) Low on-resistance, low power dual 4x1 analog multiplexers such as Maxim MAX4052, MAX384, Vishay DG412HS, or Pericom PS4066 or PS323 (with separate decoding logic or additional microcontroller address lines), and 2) The microcontroller network 24 selects the electrode connection to carry the stimulation current (and timing the interphase delay) via the address line.

(IV. Electrodes and their implantation)
The configuration of the electrodes 14 and the manner in which they are embedded can vary. A representative embodiment is described with reference to FIGS.

  In the illustrative embodiment, each electrode 14 and lead 12 comprises a thin flexible component made of a metal and / or polymer material. By “thin” is intended that the electrode 14 should not be greater than about 0.75 mm (0.030 inches) in diameter.

  Electrode 14 and lead 12 can comprise, for example, one or more wound metal wires having an open or flexible elastomeric core. The wire can be insulated with a biocompatible polymer film such as, for example, polyfluorocarbon, polyimide, or parylene. Electrode 14 and lead 12 are desirably coated with a textured bacteriostatic material that still allows easy removal at a later date and helps stabilize the electrode in a manner that increases resistance.

  Electrode 14 and lead 12 are electrically isolated everywhere except one (monopolar), two (bipolar), or three (tripolar) conductive locations near their distal ends. Each of the conductive locations is connected to a conductor that spans the entire length of the electrodes and leads and provides electrical continuity from the conductive location to the electronic pod 20 via connectors 29 and 29 '. The conductive location may include a non-insulated region of the otherwise insulated conductor that spans the entire length of the totally insulated electrode. The non-insulated conductive regions of the conductor can be formed differently, for example, wound at different pitches, wound at larger or smaller diameters, or shaped to different dimensions. The conductive location of the electrode may include a separate material (eg, a metal or conductive polymer) that touches the body tissue to which the wire conductor is bound.

  In an alternative configuration, the leads 12 are not terminated in the connector, but rather the insulated leads are electrically connected to the electronic pod 20 or carrier 16 via an automatic connection method that connects and terminates the leads 12.

  The electrode 14 and the lead 12 desirably provide an operating life without mechanical and / or electrical failure, taking into account the dynamics of the surrounding tissue (ie stretching, bending, pressing, tensioning, crushing, etc.). It possesses mechanical properties in terms of flexibility and fatigue life. The electrode material desirably suppresses connective tissue ingrowth along its length so as not to hinder its withdrawal at the end of its use. However, it may be desirable to promote connective tissue ingrowth at the distal end of the electrode to enhance its anchoring in the tissue.

  Furthermore, the desired electrode 14 may also include an anchoring element 48 (see FIGS. 14 and 15) at its distal end. In the illustrative embodiment, the anchoring element 48 takes the form of a simple barb. The anchoring element 48 is sized and configured to hold the tissue when in contact with the tissue in order to resist removal or movement of the electrode from the precise location of the surrounding tissue. Desirably, anchoring element 48 is prevented from fully engaging body tissue until the electrode is introduced. The electrodes are not introduced until they are correctly placed during the implantation (installation) process, as detailed below.

  In one embodiment, electrode 14 and lead 12 can include a metal stylet in its core. The stylet movement relative to the electrode body and / or associated introducer (if used) is used to introduce the electrode by bringing the anchoring element 48 into contact with body tissue. In this setting, the stylet is removed as soon as the electrode 14 is placed in the desired region.

  In the illustrated embodiment (see FIGS. 13 and 14), the electrode 14 is housed within the electrode introducer 50 and implanted percutaneously. The electrode introducer 50 includes an axis having a sharp needle-like distal end that penetrates the skin and tissue to the target tissue region. Electrode 14 and lead 12 are loaded into the lumen of introducer 50 and anchoring element 48 is protected from complete tissue contact within the axis of introducer 50 (see FIG. 13). In this way, the introducer searches for the desired final electrode implantation site (see FIG. 13) and tissue before introducing the electrode (see FIG. 14) and withdrawing the introducer 50 (see FIG. 15). The inside can be operated freely.

  The electrode introducer 50 is insulated over the entire length of the shaft except for those regions that coincide with the exposed conductive surface of the electrode 14 housed within the introducer 50. These surfaces outside the introducer 50 are electrically isolated from each other and from the axis of the introducer 50. These surfaces are electrically connected to the connector 64 at the end of the introducer body (see FIGS. 13 and 14). This allows connection to the stimulation circuit 66 (see FIG. 13) during the implantation process. Applying a stimulation current through the outer surface of the introducer 50 results in a very close response to the response that occurs when the electrode 14 is introduced at this position of the introducer 50.

  The electrode introducer 50 is sized and configured to be bent manually prior to its insertion through the skin. Thereby, the doctor can position the electrode 14 at a position that is not on an unobstructed straight line with respect to the insertion site. This configuration and material of the electrode introducer 50 bends without interfering with the introduction of the electrode 14 and the extraction of the electrode introducer 50 and allows the electrode 14 to remain in the tissue.

  In an alternative embodiment (see FIGS. 16-18A, 17B, and 17C), the electrode introducer 50 includes a distal needle region 70 that can be deflected or steered by operation of a remote steering actuator 72. Remote bending of the needle region 70 is another method for facilitating the guiding of the electrode 14 to an unobstructed straight line position with respect to the insertion site.

  The generation of the bendable needle region 70 that can be deflected remotely can be accomplished in various ways. In the illustrative embodiment, the needle region 70 includes a semi-flexible conductive needle extension 74. The needle extension 74 is telescoped into the distal end of the introducer 50, which means that the extension 74 is slidable within the introducer 50. The semi-flexible needle extension 74 includes an internal lumen 78 that leads to the internal lumen of the introducer 50 through which the electrode 14 passes. Thus, the electrode 14 can be introduced through the lumen 78 of the needle extension 74.

  For example, small linear motors 76L and 76R employing conventional micro-electromechanical system (MEMS) technology connect the proximal end of the needle extension 74 with the introducer 50. The motors 76L and 76R are desirably mounted in a spaced relationship, which is approximately 180 degrees in the illustrated embodiment.

  By driving motors 76L and 76R forward or backward, respectively, at the same speed, flexible extension 74 extends or retracts from introducer 50 in a linear path. When the motors 76L and 76R are driven at different speeds, in different directions, or both, a bending torque is generated in the needle extension 74 and deflects the extension. For example, when the left motor 76L is driven forward at a higher speed than the right motor 76R (or the left motor 76L is driven forward while the right motor 76R is driven in the reverse direction), the needle extension portion 74 is As shown in FIG. 18, it is deflected to the right. Conversely, when the left motor 76L is driven at a slower speed than the right motor 76R (or the right motor 76R is driven forward, while the left motor 76L is driven in the reverse direction), as shown in FIG. The extension 74 is deflected to the left.

  In this setting, the steering actuator 72 can comprise a conventional joystick device, for example. As shown in FIGS. 17 and 18, a variable drive speed / direction can be applied to motors 76L and 76R to deflect or steer needle extension 74 in the desired direction by manipulating joystick device 72, as shown in FIGS. it can. Thereby, the path taken by the introducer 50 through the tissue can be directed. While inducing the introducer 50 in this manner, a stimulation current can be applied through the outer surface of the needle extension 74 until a location having the desired stimulation response is found. The electrode 14 can be introduced via the needle extension 74 and fully engages the electrode anchoring element 48 in the body tissue in the manner previously described, and the introducer 50 is subsequently withdrawn.

  Instead of the MEMS linear motors 76L and 76R, a conventional push-pull steering wire can pass through the lumen in the introducer 50 and be coupled to the needle extension 74. The operation of the actuator 72 presses or pulls the wire to affect the bending of the extension 74 as described above.

(V. Installation of nerve stimulation assembly)
Prior to installation, the clinician identifies the specific muscle and / or nerve area to which the prescription therapy using the nerve stimulation assembly 10 is applied. The specific types of therapies that are possible using the neural stimulation assembly 10 are described below. As soon as specific muscle and / or tissue regions are identified, the clinician begins to percutaneously implant one or more electrodes 14 and leads 12 one by one through the desired skin region 68. While each lead 12 is implanted, the electrode introducer 50 applies a stimulation signal until the desired response is achieved, and the electrode 14 is introduced and the introducer 50 is withdrawn.

  As soon as each electrode is implanted (see, eg, FIG. 13), the clinician can thread each electrode lead 12 through a lead connector 29 on the electronic pod 20 (or carrier 16).

  The following illustration describes the use of a neurostimulator assembly 10 that is worn on the patient's outer skin surface. It should be understood that the neurostimulator assembly 10 can be carried by a patient or can be temporarily secured to a bed or other structure, and the lead 12 extends to the assembly 10. The carrier 16 is positioned on the skin in the desired area that allows electrical connectivity to the lead 12 and corresponding connector 29 '(see FIGS. 2 and 3A). The carrier 16 is fixed in place with an adhesive 18 below the carrier. As noted above, the adhesive region desirably contains a bacteriostatic filler that prevents skin irritation or superficial infection that can lead to early removal.

  After implanting one or more electrodes 14 and passing each lead 12 through the carrier 16, the clinician may snap the electronic pod 20 into the carrier 16 (or into the electronic bay 22 if included). Good. In addition, a power supply 32 is also snapped into the power input bay 30 in the electronic pod 20 to supply power to the network 24, as shown in FIG. 3A. The clinician can connect connectors 29 and 29 'together to complete the stimulation pathway. The nerve stimulation assembly 10 is ready for use. It should be understood that the electronic pod 20 and the power source 32 can be coupled to the carrier 16 when the carrier is secured to the skin.

  Typically, as shown in FIG. 19A, a container 52 holding a prescribed number of exchange power sources 32, for example 7 or 14, is provided to the nerve stimulation assembly 10 to form a nerve stimulation system 54. The power supply 32 can be compared to a “tablet”, which is a “dose” of power to the stimulation network that provides a dosage for the tablet-based drug treatment regime in which the pharmaceutical tablet is formulated. It is. This gives the patient a sense of responsibility for the treatment, increases compliance during the treatment period, and allows delivery of scheduled stimuli such as daily or every other day or once a week. The container 52 also includes one or more disposable power supplies for a daily or prescribed period, ie, one or more compartments for holding “tablets”, to help comply, 7 days (or more or less) It may be in the form of a minute tablet case or similar organizing container 53 (see FIG. 19B).

  Usage instructions 56 may accompany the nerve stimulation system 54. Instruction 56 prescribes the use of nerve stimulation assembly 10 including periodic removal and replacement of power supply 32 with a new power supply 32. Thus, in the same way that a tablet-based drug treatment regime indicates a regular “dosage” by taking a tablet, the indication 56 is a periodic “periodic” of the neurostimulation assembly 10 via power exchange. A neural stimulation regime is prescribed that includes “powering” or administration. In the context of the neural stimulation system 54, the power supply 32 becomes the therapeutic equivalent of a tablet (ie, is part of the user action taken to expand the treatment).

  The various devices and components described above can be integrated for use with functional kits 82 and 84, as shown in FIGS. 19C and 19D. The kit can take a variety of forms. In the illustrated embodiment, each kit 82, 84 comprises a sterile packaged assembly. Each kit 82, 84 includes an internal tray 86 that holds the contents, eg, made from stamped cardboard, plastic sheet, or thermoformed plastic material. Each kit 82, 84 also preferably includes instructions for use 56 to use the contents of the kit to perform a desired therapeutic and / or diagnostic goal.

  Of course, the instructions 56 can vary widely. The instructions 56 shall be physically present in the kit, but can also be supplied separately. The instructions 56 can be embodied in separate instructions or in video, audio tape, CD and DVD. The use instruction 56 can also be used from an Internet web page.

  The arrangement and contents of the kits 82, 84 can vary widely. For example, FIG. 19C shows a kit 82 that includes the nerve stimulation assembly 10 with a tablet container 52 or organizing container 53 (as shown). Use instructions 56 in the kit instruct the user to remove and replace the nerve stimulation assembly 10 along with the operation of the nerve stimulation system 54. Kit 84 is similar to kit 82 except that kit 84 also includes one or more leads 12. In addition, the usage instruction 56 in the kit 84 instructs the clinician to install and lead the nerve stimulation assembly 10 in addition to instructing the user to operate the nerve stimulation system 54 and to remove and replace the nerve stimulation assembly 10. And the implantation of electrodes 14 and the connection of leads to assembly 10 is also indicated.

  As shown in FIGS. 7 and 8, an external desktop or handheld (preferably also battery powered) pre-programmed device 46 is used to program or display stimulation regimes and parameters within the neural stimulation assembly 10. And can be used to download recorded data from the neural stimulation assembly 10 for further processing. The device 46 can communicate with the neurostimulation assembly 10 by, for example, a cable connection 58, by high frequency magnetic field coupling, by infrared light, or by RF radio 59. As described above, the power input bay 30 further includes a communication interface coupled to the communication cable 58 connected to the device 46. The communication cable 58 supplies power to the neural stimulation assembly 10 during programming and communication with the network 24 of the neural stimulation assembly 10. The external programming device 46 can also be a general purpose personal computer or personal digital device equipped with a suitable custom program and a suitable cable or interface box for connection to the communication cable 58.

  The programming device 46 allows the clinician to customize the stimulation parameters and regime timing belonging to the individual neural stimulation assembly 10 according to the user's specific requirements and the clinician's treatment goals. Once customized, the neurostimulation assembly 10 can be disconnected from the programming system, allowing for portable or skin-mounted operations as described above. The programming device also allows for readout of usage information that allows the clinician to accurately assess patient compliance with a prescribed treatment policy or regime. Alternatively, as described above, the clinician may use push buttons, displays, and any concave buttons to program stimulation parameters and timing and to retrieve important usage data.

(VI. Use of a typical neural stimulation assembly / system)
(A. Overview)
The nerve stimulation assembly 10 and / or the nerve stimulation system 54 described above provides an electrical connection between a muscle or nerve inside the body and a stimulus generator or recording instrument mounted on or mounted on the surface of the skin. By providing, it is possible to provide a short-term treatment or diagnostic test. Programmable code 26 of neural stimulation assembly 10 and / or neural stimulation system 54 can be programmed to perform a number of neural stimulation functions, representative examples of which are described for purposes of illustration. .

(B. Temporary non-surgical diagnostic evaluation)
Prior to administering certain permanent implantable neuromodulation or nerve stimulation systems (eg, urinary incontinence, vagus nerve stimulation for treatment of epilepsy, spinal cord stimulator for pain relief) and / or nerve stimulation assembly 10 and / or nerves The stimulation system 54 can be applied to provide doctors and their patients with some assurance that treatment can be performed via temporary stimulation of the end organs. This allows physicians to screen patients who may not be candidates for permanent treatment or who may not benefit from a treatment that is worthy of surgical implantation of a permanent system.

  Particular examples include the treatment of C5-6 limb paralysis. C5-6 limb paralysis cannot extend the elbow. Inability to extend the elbows, they are limited to access only to the area directly in front of the body and need assistance in many activities of daily life. They rely on the use of biceps to perform most of the upper limb tasks. With limited or no functioning hands, they rely on prostheses to accomplish many self-care activities such as grooming and hygiene and feeding.

  An existing surgical procedure to restore elbow extension is to move a portion of the deltoid muscle to the triceps. This irreversible surgical procedure requires extensive surgical intervention, long postoperative immobilization and long-term rehabilitation. Furthermore, the time frame for a person to recover from surgery and obtain useful results after surgery is more than 3 months, and it may take a year to get full elbow extension.

  As an alternative to the transfer from the deltoid to the triceps, the pulse generator is implanted in a minimally invasive manner in conjunction with the leads / electrodes in conductive contact with the peripheral motor nerves that innervate the triceps Can be. The pulse generator can be programmed to provide single channel electrical stimulation to peripheral motor nerves that innervate the triceps to provide elbow extension. By adding the ability to extend the elbow, reach and workspace can be significantly increased, thus allowing further independence. With elbow extension, the ability to reach overhead or extend the arm laterally outwards greatly increases this workspace, and therefore gives you more freedom to complete tasks that would otherwise be out of reach. enable. This extension ability also provides better control of the subject because it provides co-contraction of elbow flexors and extensors simultaneously.

  The first phase of the treatment and evaluation period is preferably performed to identify whether the person has an innervated triceps that responds to electrical stimulation. When the muscle is innervated and functioning, the physician can provide proper elbow extension in both a horizontal plane, such as reaching out, and a vertical plane, reaching up. Determine whether or not. The individual must also be able to overcome the power of triceps stimulation with biceps by demonstrating that the elbow can still bend while stimulating the triceps. This can usually be tested by having a person put his hand on his mouth.

  The evaluation process can be accomplished with a percutaneous or surface neurostimulator of the type described herein. The stimulator carries an on-board electronic pod 20 that generates a desired current pattern to generate electrical stimulation of radial innervation in the triceps. The pod contains a microprocessor-based programmable network 24 that generates stimulation current, time or ordered stimulation pulses and records and monitors usage. As described above, a user interface / programmer may be used.

  When using a percutaneous electrode, the circuitry of the electronic pod 20 is physically and electrically connected to the percutaneous lead of the electrode. After replacement of the percutaneous lead, the stimulator settings can be programmed either by direct connection to the programmer or by a wireless link. Stimulation is applied using a 0-200 microsecond pulse at 20 Hz. The force of triceps activity can be determined by the strength of their biceps. The subject must maintain the ability to bend the elbow comfortably during triceps stimulation. A stronger biceps allows for stronger stimulation to the triceps. The subject may need a conditioning phase of 1 to 2 weeks after initial setup to increase the durability of the triceps. The subject must demonstrate the ability to bend the elbow while stimulation is provided to the triceps. Thus, the relaxation of the biceps allows for elbow extension.

  Individuals should be treated first if electrical stimulation of radial innervation to the triceps muscle using a superficial or percutaneous stimulation program results in active elbow extension that widens the individual's previous workspace. Scheduled for stage 2.

  The second stage of treatment involves replacing the first stage stimulator with an implantable pulse generator and corresponding lead / electrode implantation.

(C. Coordinated muscle stimulation)
Muscle weakness has been observed after only a brief pause. As a result, peripheral strength training for bedridden patients, such as patients in intensive care units, has been used in an attempt to at least slow down muscle weakness to maintain some muscle conditioning.

  In an alternative embodiment of the neural stimulation system 54, the harnessed neural stimulation system 100 can provide coordinated stimulation of the target muscle to induce isometric contraction of the muscle. As shown in FIGS. 20 and 21, the system 100 includes a multi-channel neural stimulation assembly 102. The neural stimulation assembly 102 is programmable as described above and includes the ability to program coordinated stimulation between multiple electrodes 14 strategically implanted throughout the body to provide muscle conditioning. FIG. 20 shows the neural stimulation assembly 102 releasably secured to the patient's skin. FIG. 21 shows the neural stimulation system releasably secured to a portable table positioned next to the patient.

  The neural stimulation assembly 102 includes one or more connectors 104 that couple to one or more cable harnesses 106. The connector 104 replaces the lead connector 27 shown in FIG. The opposite end of cable harness 106 is then connected to lead 12 and electrode 14. A return electrode 108 may also be included and coupled to the cable to provide a return path for electrical stimulation to avoid inducing current near or across the heart.

  As previously described, the neural stimulation system 100 desirably uses a prescribed number of replacement power sources 32 and a prescribed use of the neural stimulation assembly 102 that includes periodic removal of the power sources 32 and replacement with new power sources 32. Also included is a container 52 that holds instructions 56.

  FIG. 22 shows a collaborative stimulation system 150 similar to the system 100 shown in FIG. The coordinated stimulation system 150 is adapted to provide coordinated stimulation of the target muscle to induce isometric contractions. The neural stimulation assembly 152 is programmable as described above and includes the ability to program coordinated stimulation between more electrodes 14 strategically implanted throughout the body to provide muscle conditioning.

  The system 150 includes a master stimulation assembly 152 and multiple slave stimulation assemblies 154 and can also be configured as shown in FIG. 21, that is, the master assembly 152 is released to a portable table positioned next to the patient. It can be linked as possible. Each slave assembly 154 may be electrically coupled to the master assembly 152 in series or in parallel as shown. The master assembly 152 is programmed to provide coordination between each of the slave assemblies 154. Lead connector 27 provides connectivity to one or more system cables 156. Instead of cables 156, master assembly 152 may use wireless telemetry to communicate with each slave assembly 154.

  Again, as previously described, the neural stimulation system 150 desirably prescribes the use of the neural stimulation assembly 102 that includes a prescribed number of replacement power sources 32 and periodic removal of the power sources 32 and replacement with new power sources 32. Also included is a container 52 that holds a use instruction 56 to be used.

(D. Continuous Active Motion (CAM))
The CAM using the neurostimulation assembly 10 and / or the neurostimulation system 54 provides the stimulation necessary to improve cardiovascular durability, muscle strength, and neurological coordination. Through CAM, this actively assisted exercise is a technique used to assist the active voluntary movement of the target limb, thereby reducing the amount of strength needed to move the joint. is there. This technique has proven effective in increasing the strength of individuals starting at a very low level. Therapeutic utility includes reduced inflammation of the affected joint, increased range of motion, analgesia, and increased functional motility. CAM is distinguished from continuous passive motion (CPM), which is the movement of a joint or limb in a range of motion without limb muscle contraction.

(E. Posttraumatic anti-scarring treatment :)
Post-surgical scarring (eg, posterior approach to the spine) is a problem for most orthopedic or neurosurgical procedures. Scarring or adhesions, that is, the fibrous band of scar tissue that usually joins together distinct anatomical structures during the healing process, can be one of the single biggest reasons for a patient's surgical “failure” . Supremely well performed surgery by a good surgeon can be wasted in a short time due to the body's tendency to scar during postoperative treatment. By applying the nerve stimulation assembly 10 and / or the nerve stimulation system 54 to the muscle or nerve of a particular surgical wound, relatively small movements can prevent scarring while the tissue is healed.

(F. Neuroplasticity therapy)
Individuals with neurological deficits, such as stroke survivors or individuals with multiple sclerosis, may lose certain physical function controls. The brain may restore function through a process called “neuroplasticity” by reorganizing the cortical map or spinal root interface and increasing the supplemental blood supply, which contributes to neurological recovery. To contribute. Applying neurostimulation assembly 10 and / or neurostimulation system 54 to the affected area and providing excitement and input to the brain may result in neuroplastic utility and control of the brain's lost function. Allows you to relearn and recover.

(G. Anticonvulsant therapy)
The use of temporary neurotoxins (eg, Botox) helps to improve gait, positioning, and daily activities, as well as for severe muscle spasms caused by cerebral palsy, head trauma, multiple sclerosis, and spinal cord injury Spread in treatment. Botox can also be used to treat eye conditions that cause the eyes to cross, ie, to continuously blink the eyelids. It is also said that wrinkles are removed by relaxing the small subcutaneous muscles. The nerve stimulation assembly 10 and / or the nerve stimulation system 54 may be used as an alternative means to reduce spasticity without temporarily paralyzing nerves and muscles. Also, the neural stimulation assembly 10 and / or the neural stimulation system 54 is limited in the ability to perform normal movements of speech, facial expression, feeding, mastication, and swallowing as well as pain and related muscle spasms in the mandibular region. , May be useful in the treatment of TMJ (temporomandibular joint) disorders.

(H. Chronic or temporary pain treatment)
Localized pain in any area of the body can be treated using the nerve stimulation assembly 10 and / or the nerve stimulation system 54 by applying directly to the affected area. The neural stimulation assembly 10 and / or the neural stimulation system 54 functions by blocking the pain signal or preventing the pain signal from reaching the brain.

(I. Reconditioning after surgery)
Recovery of strength and muscle function after surgery can be facilitated using the nerve stimulation assembly 10 and / or the nerve stimulation system 54. The assembly 10 and / or system 54 provides a temporary regime of muscle stimulation, alone or in conjunction with an active exercise program, to help restore muscle tone, function, and conditioning after an individual's surgery. In order to be prescribed after surgery, it can be placed in relation to the appropriate muscle area.

(J. Prevention of thromboembolism)
The nerve stimulation assembly 10 and / or the nerve stimulation system 54 can provide antithrombotic therapy by stimulating leg muscles, increasing venous return and preventing thrombus associated with blood storage in the lower extremities. Periodic postoperative therapy currently uses a pneumatic compression cuff that is worn on the calf while the patient is in bed. The cuff compresses the gastrocnemius muscle periodically and mechanically, thereby stimulating venous return. Patients dislike it, but all units in the hospital now have this unit attached. This same effect can be replicated by installing the neural stimulation assembly 10. Since most, if not most, thrombus forms during surgery, prevention is most effective if initiated during surgery. Accordingly, it is desirable to install the nerve stimulation assembly 10 and begin using the nerve stimulation system 54 at the beginning of the surgery.

(K. Treatment of osteoporosis)
Periodic muscle contraction loads the bone enough to prevent (and possibly reverse) osteoporosis. The effectiveness of such treatment is known to be frequency dependent. The nerve stimulation assembly 10 and / or the nerve stimulation system 54 can be programmed to stimulate muscles at an appropriate frequency to prevent / reverse osteoporosis.

(L. Neuroprosthesis)
Recovery of lost movement due to paralysis or injury can be achieved. The nerve stimulation assembly 10 and / or the nerve stimulation system 54 can be controlled in real time via an external control source such as a heel switch monitoring gait. This external control source triggers the neural stimulation system to be ready for a pre-set time, allowing functional movement of the person's lower limb or upper limb, thereby restoring a previously non-functional paralyzed limb Let

(M. Body sculpting)
The proportion of muscles in the human anatomy can be augmented and their overall muscle definition can be altered by neural stimulation of specific groups of muscles. An example of abdominal stimulation is to increase strength and increase muscle tone and definition. The nerve stimulation assembly 10 and / or the nerve stimulation system 54 can be programmed to stimulate the muscle at an appropriate frequency to change the body shape and compensate for the effects of exercise.

  Various features of the invention are set forth in the following claims.

Claims (25)

At least one electrode;
A carrier sized and configured to be worn by a user;
An electronic pod that is detachably mounted on-board to the carrier and includes a network configured to generate stimulation pulses to the electrodes; and
A neural stimulation assembly comprising: a power input bay mounted onboard the electronic pod electrically coupled to the network, the power input bay sized and configured to receive a disposable power source.   The assembly of claim 1, wherein the disposable power source includes circuitry for electronically storing information about the power source.   The assembly of claim 2, wherein the power network comprises a non-volatile memory.   The assembly of claim 1, wherein the electronic pod circuitry includes a non-volatile memory for electronically storing information about the power source.   The assembly of claim 2, wherein the electronically stored information is selected from the group comprising power usage data, unique power identification, and power capacity.   The assembly of claim 4, wherein the electronically stored information is selected from the group comprising power usage data, unique power source identification, and power capacity.   The assembly of claim 1, further comprising an adhesive region on the carrier for temporarily securing the carrier to an external skin surface in use.   The assembly of claim 7, wherein the adhesive region further comprises a surface return electrode. At least one electrode;
A carrier sized and configured to be worn by a user;
An electronic pod onboard the carrier, the circuitry configured to generate stimulation pulses to the electrodes, allowing user input to the circuitry to regulate the stimulation pulses A neural stimulation assembly comprising: a user interface adapted to and an electronic pot including a visual output of neural stimulation assembly information.   The assembly according to claim 9, wherein the electronic pod is detachably mounted on the carrier.   The power input bay mounted onboard the electronic pod electrically connected to the circuitry, the power input bay being sized and configured to accept a disposable power source. The assembly described.   And further comprising a power input bay mounted onboard the carrier electrically coupled to the circuitry, the power input bay sized and configured to hold a power source, the power input bay comprising the power input bay The assembly of claim 9, wherein the assembly is also sized and configured to establish a communication link between the circuitry and the external device.   The assembly according to claim 9, wherein the visual output comprises a display unit mounted onboard the electronic pod.   The assembly of claim 9, wherein the visual output is provided by an illumination source that illuminates at least a portion of the electronic pod. A carrier sized and configured to be worn by a user,
Circuitry configured to generate stimulation pulses;
An electronic pod sized and configured to hold a disposable power source for the network that can be released and replaced to power the network;
Sizing and configuring an electrode lead to electrically engage an electrode adapted to be percutaneously implanted in the target tissue region for percutaneously applying the stimulation pulse to the target tissue region A carrier comprising:
Instructions for use provided by a clinician, caregiver, or physician prescribing the release and replacement of the disposable power source according to a prescribed power exchange regime;
The prescribed power supply replacement regime includes instructions for use including the replacement of the prescribed repeat-based disposable power supply, similar to administering tablets under a prescribed tablet-based drug treatment regime;
A neural stimulation system comprising: a supply of power provided in a storage container including one or more disposable power supplies for a daily dose or for a period of the prescribed power exchange regime.   16. The organizing container is in the form of a daily tablet case that includes one or more compartments that hold one or more disposable power supplies for a daily or period of the prescribed power exchange regime. System. At least one electrode;
A carrier sized and configured to be worn by a user, comprising a stimulation network configured to generate stimulation pulses to the electrodes;
A disposable power supply releasably coupled to the stimulation network, the housing being positioned within the housing and adapted to store information about the power supply. A neural stimulation assembly comprising a power supply network and a disposable power supply.   The power input bay mounted on board the carrier electrically coupled to the stimulation network, the power input bay being sized and configured to receive the disposable power source. The assembly described in 1. At least one electrode;
A carrier sized and configured to be worn by a user;
An electronic pod mounted on the carrier and having a cover, the electronic pod comprising a network configured to generate stimulation pulses to the electrodes;
The neural stimulation assembly includes an illumination source adapted to provide a light-emitting appearance of at least a portion of the cover to provide visual feedback of neural stimulation assembly information to the user.   The assembly according to claim 19, wherein the electronic pod is detachably mounted on the carrier.   20. The assembly of claim 19, wherein the light emitting appearance is selected from the group comprising a blinking or pulse configuration, illumination brightness, color change, or any combination.   A method for assessing whether a person responds to electrical stimulation of a nerve to reduce bladder dysfunction comprising the step of using the assembly defined in claim 1. A method of providing neural stimulation to a tissue,
Providing a neural stimulation assembly comprising:
The neural stimulation assembly includes a carrier sized and configured to be worn by a user, the carrier comprising:
A network configured to generate stimulation pulses and sized and configured to hold a disposable power source for the network that can be released and replaced to power the network An electronic pod,
Sized and configured to electrically engage an electrode lead to an electrode that is percutaneously implanted in the target tissue region for transcutaneously applying the stimulation pulse to the target tissue region An electrode connecting element, and a step;
Providing a supply of power provided in a storage container comprising one or more disposable power supplies for a daily portion or for a period of the prescribed power exchange regime;
Installing one of the power sources in the electronic pod to provide power to the network;
Manipulating the neural stimulation network to apply the stimulation pulse to the target tissue region.   The organizing container is in the form of a daily tablet case that includes one or more compartments that hold one or more disposable power supplies for daily or other prescribed intervals of a prescribed power supply replacement regime. Item 24. The method according to Item 23. A kit of apparatus for providing neural stimulation to a target tissue region comprising:
A stimulation electrode sized and configured to be implanted within the target tissue region;
A nerve stimulation assembly sized and configured to be worn by a user, the nerve stimulation assembly sized and configured to hold a disposable power source;
A lead for connecting the stimulation electrode to the neural stimulation assembly;
A supply of power provided in a storage container including one or more disposable power supplies for a daily portion or a period of the prescribed power supply replacement regime;
Instructions provided by a clinician, caregiver, or physician prescribing the release and replacement of the disposable power source according to a prescribed power exchange regime, wherein the prescribed power exchange regime is a prescribed tablet A kit comprising instructions for use, including replacement of a prescribed, repeat-based, disposable power supply similar to administering a tablet under a base medication regime.

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