Electrical stimulator for peripheral stimulation

Abstract

Neural stimulation assemblies, systems, and methods enable short-term therapy or diagnostic testing to be provided by providing an electrical connection between a muscle and / or a nerve within a body and a stimulator and / or a recorder mounted on a skin surface or carried outside the body. The assemblies provide maximum patient mobility and comfort through differentiated components that have minimal profile and are connected through detachable and adjustable connections.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent Application No. 62 / 084,744, filed November 26, 2014. The disclosure of this application, together with any other U.S. patents and U.S. patent publications recognized in this specification, is hereby incorporated by reference. Technical Field

[0003] This disclosure generally relates to an electrical stimulator, and more specifically, to a mobile electrical stimulator system for peripheral electrical stimulation. Background Technology

[0004] Neurostimulation and brain stimulation can provide functional and / or therapeutic outcomes. While existing systems and methods offer benefits to individuals requiring neurostimulation, many quality-of-life issues remain. For example, existing systems are only performed in clinical settings under the supervision of clinicians, limiting the applicable users and the time available for stimulation. Furthermore, the controllers used in these clinical settings are relatively large by today's standards and cumbersome to operate and transport.

[0005] There are two types of devices: external devices and implantable devices, used to deliver neurostimulation in various therapeutic and functional recovery indications. These neurostimulators are capable of providing treatment to individual parts of the body. Operation of these devices typically involves the use of electrodes placed on the outer surface of the skin and / or surgically implanted electrodes. In the case of external neurostimulators, surface electrodes and / or percutaneous leads (one or more) having one or more electrodes are used to deliver electrical stimulation to selected parts (one or more) of the patient's body.

[0006] For example, transcutaneous electrical nerve stimulation (“TENS”) is delivered via electrodes placed on the skin surface, but it has not yet achieved widespread use due to therapeutic limitations, muscle fatigue, and limited efficacy. TENS is similar to electromuscular stimulation, but the latter is intended for stimulating muscles, not nerves.

[0007] Several clinical and technical problems associated with surface electrical stimulation hinder surface electrical stimulation from becoming a widely accepted treatment method. First, stimulation of cutaneous pain receptors is unavoidable, resulting in stimulation-induced pain that limits patient tolerance and compliance. Second, electrical stimulation is delivered to the patient at a relatively high frequency to prevent stimulation-induced pain, which then results in early onset of muscle fatigue. Third, it is difficult to stimulate deep nerves with surface electrodes without stimulating overlying, shallower nerves, resulting in unwanted stimulation. Further, reliably placing surface electrodes and adjusting stimulation parameters each day to provide optimal treatment requires clinical skill and intensive patient training. The required daily maintenance and adjustment of surface electrical stimulation systems is a major burden on both patients and caregivers.

[0008] Several previous systems for spinal cord stimulation (e.g., at the dorsal root ganglion) and / or other deep tissue stimulation required electrodes and / or other devices to be implanted through surgery for delivery of therapy. These therapies necessarily incur the costs and medical risks associated with invasive surgery, and can limit patient mobility both in terms of the surgery itself and, in some cases, post-surgical activities that the ambulatory patient can wish to engage in while in his / her home environment.

[0009] Furthermore, many previous stimulation systems require complex interfacing systems to operatively attach the lead to the stimulator. These systems often require separate tools to operatively attach the lead to the stimulator, require more than one person to accomplish, or are difficult to operatively attach. Often, connectors are used to operatively attach the lead to the stimulator. These connectors are often uncomfortable for the patient to wear, require a clinician to be very dexterous to attach, and / or require additional tools to attach.

[0010] U.S. Patents 6,845,271 and 8,249,713 describe methods of treating shoulder dysfunction through transcutaneous electrical stimulation. Specific asynchronous stimulation patterns are delivered via multiple coiled or spiral wire electrodes with terminal barbs inserted into target muscles. The electrodes can be inserted by a hypodermic needle or surgically.

[0011] U.S. Patent 7,376,467 discloses a neuromuscular stimulation assembly including a steerable introducer defining an internal lumen that shields the electrodes from contact with tissue during insertion. The electrodes suitable for the assembly can be cutaneous or transcutaneous. The assembly includes a carrier that is adhesively secured to the patient, the carrier having an electronics housing for generating a desired current pattern and an optional power input cradle that enables replacement of a battery for the assembly. Electrical connections between the electrodes and the power source are established via slots integrally formed on the housing.

[0012] U.S. Patent 8,463,383 contemplates a neurostimulation assembly for short term therapy or diagnostic testing via a thin wire electrode. The assembly includes a carrier and an optionally movable electronics housing associated with the carrier. The housing generates stimulation pulses and includes a user interface component. A power source and optional memory unit are contained within the assembly and more particularly can be contained in the return electrode itself.

[0013] U.S. Patents 8,626,302 and 8,954,153 and U.S. Patent Publication 2013 / 0238066 disclose methods for pain relief via transcutaneous and / or peripheral nerve electrical stimulation. As with the other methods noted above, a subcutaneous injection needle and lumen combination can deliver the lead. Various stimulation parameters are disclosed in these.

[0014] U.S. Patent 8,700,177 describes a system and method involving the use of an adhesive patch with mounting structure directly mated to an electrical stimulation device. Transcutaneous electrodes are electrically coupled to the stimulation device. The device has a low profile and can be controlled wirelessly or through a plug connection. A rechargeable battery powers the device, which can be inductively charged. SUMMARY

[0015] A compact mobile system for peripheral electrical nerve stimulation is disclosed. The system enables targeted delivery of stimulation while circumventing skin pain receptors and without the need for open or invasive surgical procedures. The system enables a relatively wide range of possible pulse profiles to be achieved while reducing the risk of muscle fatigue and minimizing the need for patients to rely on skilled personnel to maintain or monitor the system.

[0016] One particularly relevant aspect of the system is that it includes one or more "breakaway" connections to ensure that the electrodes and / or lead do not become displaced in the event that inadvertent or unwanted forces (e.g., the application of a predefined force) being applied to the lead or its connections cause the patient cable (or lead) to break away from the stimulator. These breakaway connections can completely disconnect and / or simply reduce the tension of the connection to ensure that the electrodes are not affected. Further, the system can provide a warning to the user in the event of a disconnection or reduced tension so that the user can confirm that the system is still operational. These features, whether considered individually or in combination, prevent the user from being confined to the clinician's office (or other restricted mobility / entry area) during the treatment, but rather enable the user to participate in daily activities.

[0017] The system is more easily used by the patient and allows the clinician to attach it to the patient. The system does not require a tool to operatively attach the lead to the stimulator. Still further, the system can allow the clinician to use only one hand to operatively connect the system together.

[0018] Another aspect of the system is that it can be lightweight, have a generally low profile, and be adaptable. Specifically, after the electrodes are positioned within the body, the combination of the adhesive bandage, lead connector, and patient cable can allow the user to adjustably position the stimulator case in a convenient location on his / her body. The lead connector and other system elements can be scaled to accommodate multiple electrodes, enabling coordinated therapy in various regions of the body. The system elements can be wirelessly connected to minimize physical connections and maximize user comfort.

[0019] Additionally, the stimulator case and controller case can be further extended during treatment by using the programmer unit so that the clinician or even the user can directly control the process.

[0020] As noted above, the breakaway feature can allow the patient cable to be disconnected from the stimulator case when a predefined force is applied. The system on the body can maintain sufficient attachment force between the lead and the stimulator case to remain operatively connected during a wide range of patient activities during which therapy is needed. At the same time, the system can be able to safely and / or comfortably disconnect the patient cable from the stimulator case without damaging and / or dislodging the system and / or any of its components (e.g., leads, connectors, stimulator, pads, etc.) and / or without harming or causing pain or discomfort to the patient. In other words, the system allows the connection between the patient cable and the stimulator case to maintain mechanical and electrical connections when needed, but also can enable safe disconnection (such as mechanical and / or electrical disconnection) when necessary. This can also enable the patient to reconnect without clinician support (enabling the patient to safely resume therapy without having to return to the clinician to have the lead, system, or other system components repaired, replaced, reprogrammed, and / or repositioned). In addition to protecting the lead connector (and attached percutaneous lead) from accidental forces on the patient cable due to catching or snagging on clothing, handled objects, or objects in the environment.

[0021] Particular embodiments of the present teachings can include any combination of the following features:

[0022] A helical wire electrode carried within an introducer (e.g., a disposable hypodermic needle or sheath);

[0023] An adhesive patch at least partially securing a proximal end of the electrode that extends from the body;

[0024] a lead connector secured to the proximal end of the electrode;

[0025] a patient cable removably connected to the lead connector;

[0026] a stimulator housing including a power source and a return electrode removably connected to the patient cable and forming an electrical connection between the housing and the electrode to deliver therapeutic stimulation;

[0027] a controller housing in communication with the stimulator housing;

[0028] a programmer unit in communication with the controller housing and / or the stimulator housing, wherein the programmer unit selectively delivers instructions notifying of therapeutic stimulation;

[0029] wherein the electrode, lead connector, patient cable, and stimulator housing form a series of removable connections having tension, and in response to a disconnecting force, at least one of the following occurs: the tension is temporarily reduced and the patient cable is removed from the lead connector;

[0030] wherein at least one of the removable connections is established by at least one of the following: a magnet and releasable spring-loaded connection, a connector having a predefined clamping strength;

[0031] wherein the programmer unit is in communication with the controller housing by a wireless connection;

[0032] wherein the needle includes at least one test stimulation electrode controlled by the controller housing to assist in positioning of the electrode;

[0033] wherein the needle includes at least one test stimulation electrode controlled by at least one of the controller housing and the programmer housing to assist in positioning of the electrode;

[0034] wherein the lead connector is divided into two parts to enable connection of multiple electrodes;

[0035] wherein the patient cable includes multiple segments, wherein each segment is removably connected;

[0036] wherein multiple stimulator housings are provided in combination with multiple electrodes, and wherein the controller housing coordinates stimulation between the stimulator housings;

[0037] wherein the stimulator housing is in wireless communication with the controller housing;

[0038] wherein the lead connector further includes a mechanical connector that accommodates and clamps the proximal end while maintaining an electrical connection between the electrode and the patient cable;

[0039] wherein the mechanical connector is releasably and resetably movable in response to a disconnecting force;

[0040] wherein the lead connector mechanically secures the lead and electrically connects to the lead in response to a force applied by a user;

[0041] wherein the mechanical connector comprises a rotating element;

[0042] wherein the mechanical connector comprises a funnel having a controllably collapsible segment, and wherein a proximal end of the lead received through the funnel and the controllably collapsible segment engages a proximal portion of the electrode;

[0043] wherein the rotating element of the lead connector electrically connects to the lead and terminates in a series of detachable connections to the stimulator housing;

[0044] wherein at least one of the stimulator housing and the controller housing provides a user warning when a predetermined amount of force (e.g., an amount that displaces the patient cable) is applied;

[0045] wherein the user warning comprises at least one of: a visual cue and an audible cue;

[0046] wherein the magnet comprises at least one insert molded neodymium magnet;

[0047] wherein the magnet is shielded to reduce unintended magnetic fields and to concentrate or focus the field between the two ends of the release mechanism;

[0048] wherein the tension is reduced to a predetermined level, and the patient cable detaches when the force exceeds the predetermined level;

[0049] wherein the predetermined level is less than or equal to a portion (e.g., one-half, 90%, 80%, 70%, etc.) of the force required to change the position of the lead connector on the patient;

[0050] wherein at least one end of the patient cable comprises a connection member that mates with a corresponding connection member on at least one of the lead connector and the stimulator housing; and

[0051] wherein there can be multiple mating connection members, and each set of mating members has a unique shape to avoid improper connections.

[0052] A transcutaneous electrical stimulator system can comprise: an electrode that is transcutaneously insertable into a patient; an adhesive bandage that at least partially secures a proximal end of the electrode that extends from the patient; a lead connector secured to the proximal end of the electrode; a patient cable detachably connected to the lead connector; and a stimulator connected to the patient cable and forming an electrical connection between the stimulator and the electrode to deliver therapeutic stimulation.

[0053] The transcutaneous electrical stimulator system described above:

[0054] wherein the electrodes, lead connectors, and patient cable form a series of detachable connections having tension, and in response to a disconnect force, at least one of the following occurs: a temporary reduction in tension and detachment of the patient cable.

[0055] wherein at least one of the detachable connections is established by at least one selected from the group consisting of: a magnetic body and releasable spring-loaded connection, a mechanical connection.

[0056] wherein a portion of the series of detachable connections is engaged via a rotational element that adjusts tension in response to a disconnect force.

[0057] further comprising a controller in communication with the stimulator.

[0058] wherein the stimulator is in wireless communication with the controller.

[0059] further comprising a programmer unit in communication with the controller, wherein the programmer unit selectively delivers instructions notifying of therapeutic stimulation.

[0060] wherein the programmer unit is in communication with the controller through a wireless connection.

[0061] wherein at least one of the stimulator and the controller provides a user alert when a response to the force occurs.

[0062] wherein the user alert comprises at least one of the following: a visual cue, a tactile cue, and an audible cue.

[0063] further comprising a programmer unit in communication with the stimulator, wherein the programmer unit selectively delivers instructions notifying of therapeutic stimulation.

[0064] wherein the lead connector is divided into a plurality to enable connection of a plurality of electrodes.

[0065] wherein the patient cable comprises a plurality of segments, wherein each segment is detachably connected.

[0066] wherein a plurality of stimulators are provided in combination with a plurality of electrodes, and wherein the controller coordinates stimulation between the stimulators.

[0067] wherein the stimulator is in wireless communication with the controller.

[0068] wherein the lead connector further comprises a mechanical connector that accommodates and grips the proximal end while maintaining an electrical connection between the electrode and the patient cable.

[0069] wherein the mechanical connector is releasably and resetably movable in response to a disconnect force.

[0070] wherein the mechanical connector comprises a rotational element.

[0071] wherein the mechanical connector includes a funnel having a segment that is controllably collapsible, and wherein a proximal end of the funnel and the controllably collapsible segment is engaged with a portion of the proximal end of the electrode adjacent thereto.

[0072] wherein the magnet includes at least one insert molded magnet formed of at least one of neodymium, samarium cobalt, alnico, and ferrite.

[0073] wherein the magnet is shielded to reduce unintended magnetic fields and / or to concentrate intended magnetic fields from the magnet.

[0074] wherein the tension is reduced to a predetermined level, and the patient cable is disassembled when the disconnect force exceeds the predetermined level.

[0075] wherein the predetermined level is less than or equal to a percentage of the force required to change the position of the electrode within the patient.

[0076] wherein at least one end of the patient cable includes a connection member that mates with a corresponding connection member on at least one of the lead connector and the stimulator.

[0077] wherein there are multiple mating connection members, and each set of mating members has a unique shape to avoid improper connections.

[0078] A percutaneous electrical stimulator system can include an electrode that is percutaneously insertable into a patient, a lead extending from the electrode, a lead connector secured to the lead, a patient cable detachably connected to the lead connector, and a stimulator connected to the patient cable and forming an electrical connection between the stimulator and the electrode to deliver therapeutic stimulation.

[0079] The percutaneous electrical stimulator system described above:

[0080] wherein the lead is a helical lead with the electrode integrally formed at an end thereof.

[0081] A percutaneous electrical stimulator system can include an electrical wire electrode that is percutaneously insertable into a patient, the electrode having a proximal end that extends from the patient when inserted therein, a lead connector secured to the proximal end of the electrode, a patient cable detachably connected to the lead connector, and a stimulator connected to the patient cable and forming an electrical connection between the stimulator and the electrode to deliver therapeutic stimulation.

[0082] The percutaneous electrical stimulator system described above:

[0083] Further comprising a controller in communication with the stimulator, wherein the electrode, lead connector, and patient cable form a series of detachable connections with tension, and in response to a disconnecting force, at least one of the following occurs: the tension is temporarily reduced and the patient cable is detached.

[0084] wherein at least one of the detachable connections is established by at least one of the following: a magnet and a releasable spring-loaded connection.

[0085] wherein the electrode is covered by an electrically insulating material except for its distal end.

[0086] wherein the mechanical connector comprises a rotating element that provides for cutting or piercing of the electrically insulating material and mechanically fixes the movement and force of the lead.

[0087] These and other features and advantages of the present teachings are set forth in the following specification, which, together with the drawings, discloses various embodiments of the present teachings. BRIEF DESCRIPTION OF DRAWINGS

[0088] These and other features, aspects, and advantages of the present disclosure are better understood when the following DETAILED DESCRIPTION is read with reference to the accompanying drawings in which:

[0089] Figure 1 is a schematic diagram of one embodiment of the present teachings.

[0090] Figure 2A and Figure 2B illustrates selected components in one embodiment of the present teachings.

[0091] Figure 3A , Figure 3B and Figure 3C are pictorial representations of lead connectors used in various embodiments of the present teachings.

[0092] Figure 4A and Figure 4B pictorially illustrates possible mating connections for magnets and other detachable connections.

[0093] Figure 5 pictorially illustrates spring-loaded and / or magnetic connections that can be used in detachable connections.

[0094] Figure 6 is a perspective view of an embodiment of the adhesive bandage of the present teachings.

[0095] Figure 7 is a perspective view of an embodiment of the adhesive bandage of the present teachings attached to a patient.

[0096] Figure 8 is a perspective view of the adhesive bandage being removed from the patient.

[0097] Figure 9 is a perspective view of the patient with the lead inserted at the insertion portion, with the lead connector attached to the lead, and the adhesive bandage removed.

[0098] Figure 10 is a perspective view of the adhesive bandage being attached to the patient.

[0099] Figure 11 is a perspective view of the lead connector operatively attached to the stimulator housing via the patient cable with the adhesive bandage attached to the patient.

[0100] Figure 12 is a schematic view of an embodiment of a lead connector.

[0101] Figure 13 is a schematic view of an embodiment of a lead connector having a lead storage mechanism.

[0102] Figure 14 is a schematic view of an embodiment of a lead connector having a lead storage mechanism.

[0103] Figure 15 is a schematic view of an embodiment of a lead connector.

[0104] Figure 16 is a schematic view of an embodiment of a lead connector.

[0105] Figure 17 is a schematic view of an embodiment of a lead connector having a storage device.

[0106] Figure 18 is a schematic view of an embodiment of a lead connector and stimulator housing with a patient cable having a detachment mechanism.

[0107] Figure 19 is a graphical representation of stimulation intensity versus amplitude and pulse duration.

[0108] Figure 20 is a perspective view of an embodiment of an IDC.

[0109] Figure 21 is a perspective view of an embodiment of an IDC.

[0110] Figure 22 is a cross-sectional view of a portion of a detachment mechanism.

[0111] Figure 23 is a cross-sectional view of a portion of a detachment mechanism.

[0112] Figure 24 is a cross-sectional view of a detachment mechanism.

[0113] Figure 25 is a cross-sectional view of a portion of a detachment mechanism. DETAILED DESCRIPTION

[0114] Exemplary embodiments of the present teachings will now be discussed in detail with numerous specific details given by way of examples. It is to be understood that other embodiments can be used and that not all of the features and components described need be used or can be used in combinations with one another. In addition, structural and functional changes can be made without departing from the scope of the present teachings. Furthermore, the features and components of the various embodiments can be combined or altered in any combination thereof, within the scope of the present teachings. In this regard, the following description is presented for purposes of illustration only and is not intended to limit the alternatives and modifications that can be made to the illustrated embodiments and that are within the spirit and scope of the present teachings.

[0115] As noted above, previous neurostimulation and neuromodulation systems have inherent weaknesses. For example, these weaknesses can include the difficulty of using the stimulator to reach locations on the body that are difficult to access when the stimulator is installed (locations on the body that have frequent movement, including but not limited to the patient's arms, back, legs, head, shoulders, etc.). In addition, it can be difficult for the clinician to couple the stimulator with the lead (including but not limited to a thin wire lead), and it can be difficult for the clinician to work with the system while it is on the patient's body. Still further, another weakness can include the inherent difficulty of operating while the system is adhered to the body, the complex user interface, the difficulty of changing the bandage without worrying about displacing the electrodes, and the discomfort due to the size and shape of the system. As will be appreciated by those skilled in the art, certain embodiments of the present teachings overcome these weaknesses and provide additional advantages.

[0116] Figure 1 The components of one embodiment of the present invention are schematically illustrated. Transcutaneous stimulation system 10 can include an electrode, such as thin wire electrode 18. Electrode 18 can be initially introduced into the body by a hypodermic needle (not shown) or any other insertion method. The present teachings are not limited to a particular type of insertion method or device. Any suitable system can be utilized without departing from the present teachings. Electrode 18 can include lead 20 extending therefrom, such as a microlead, thin wire lead, or simply a lead. In contrast to previous systems, lead 20 can have a generally smaller diameter, optimally less than 1.0 mm, and more preferably less than 0.6 mm. In addition, electrode 18 and / or lead 20 can have a generally coiled or spiral structure, rather than a smooth cylinder. However, the present teachings are not limited to this structure. Any suitable configuration can be utilized without departing from the present teachings.

[0117] For the sake of clarity, the term "proximal" in the context of the present application generally refers to the end of the electrode that is not inserted into the body, and "distal" generally refers to the end of the electrode that is inserted into the body, near the nerve. Depending on the manufacturing of the electrode structure, this proximal end can be wrapped in an insulating or protective coating or wrap. The assembly in question will allow the removal of such coating(s) / wrap(s) insofar as it is necessary to establish an electrical connection with the proximal end.

[0118] After the electrode 18 is positioned at the desired treatment location within the body 12, the proximal end of the electrode can be covered by an adhesive bandage 22 and attached to the lead connector 30. The adhesive bandage 22 can have an adhesive that at least partially covers the proximal end and, in some cases, directs the proximal end toward the lead connector 30. The adhesive bandage 22 can take any number of shapes, including but not limited to Figure 2A the shapes depicted in FIGS. 6A-6C, and the adhesive can be selectively applied to portions of the perimeter to better ensure that the proximal end does not inadvertently fall in when the necessary connections are made within the system 10. The adhesive bandage 22 can be made of any suitable film material, such as polyethylene, and can be made with one or more optional absorbent pads and / or adhesive-free removal tabs. The adhesive bandage 22 can also be carried on a disposable backing that can release the adhesive bandage 22 at the moment it is applied to the body 12.

[0119] Figures 6-11An embodiment of an adhesive bandage 22 is shown in FIG. 2. The adhesive bandage 22 can eliminate the need for a separate tape to secure the lead connector 30. The adhesive bandage 22 can be a unitary system component that can substantially protect the lead 20 exit site from exposure to potential contaminants (e.g., water, dirt, pathogens, viruses, bacteria, etc.) to help prevent infection of the site. The adhesive bandage 22 can further substantially protect the lead 20 and more specifically the electrode 18 from accidental dislodgement caused by abrasion (e.g., from body parts, clothing, or decorations). The adhesive bandage 22 can also substantially secure the lead connector 30 to the patient's skin to isolate the lead 20 from forces applied to the lead connector 30, such as forces applied during system 10 maintenance and daily living activities. The adhesive bandage 22 can be an over-bandage integrated with the lead connector 30 so that a user can easily and consistently remove and replace the adhesive bandage 22 without worrying about inadvertently pulling on the lead 20 and / or electrode 18. The adhesive bandage 22 can include a film body 42 and a skin adhesive 44 that ensures adhesion to the skin will be suitable for use on a human's skin. The film body 42 can be any suitable material, including but not limited to clear polyethylene or any other material that substantially protects the wound and prevents infection. The adhesive bandage 22 can be any suitable shape, including but not limited to a substantially oval shape. The skin adhesive 44 can be coated along the perimeter so that the lead 20 is not exposed to any of the skin adhesive 44. The skin adhesive 44 can have an appropriate amount of tack to substantially prevent inadvertent release from the skin. The skin adhesive 44 can substantially extend around the perimeter of the film body 42 of the adhesive bandage 22. This can result in a seal to substantially prevent contaminants from entering anywhere around the entire perimeter. Further, this can make the adhesive bandage 22 easier to remove so that it does not stick to the lead 20 when removed.

[0120] The adhesive bandage 22 can include a cutout 48 over the lead connector 30 that can eliminate a gap in the seal and allow a user to use their fingers to securely hold the lead connector 30 against the skin during replacement of the adhesive bandage 22. As noted above, the contours of the lead connector 30 and the adhesive bandage 22 can be made to fit together - this can result in a better seal. The adhesive bandage 22 can include a removal tab 56. The patient and / or clinician can place his / her fingers on the bandage portion 52 and the lead connector 30 to substantially prevent the lead 20 and electrode 18 from being pulled from the skin. This can be particularly useful for locations on the patient's body that are difficult to reach and on body parts that have frequent movement (e.g., legs, arms, back, head, etc.).

[0121] The membrane 42 of the adhesive bandage 22 can include a substantially see-through, translucent, transparent, or the like body having a bandage portion 52. The bandage portion 52 can include an absorbent pad configured to substantially absorb any fluids exiting the lead insertion site, e.g., any kind of liquid (including but not limited to blood) that can seep from the lead insertion site will be absorbed into the bandage portion 52. The bandage portion 52 can still be sized so that the patient and / or clinician can view the area around the lead exit site to determine the presence of any infection. Having a transparent membrane 42 further enables the patient and / or clinician to view the lead exit site. The adhesive bandage 22 can help to keep fluids from obstructing the view of the skin to help identify whether any infection is present on the patient.

[0122] Furthermore, the proximal end of the electrode 18 or lead 20 can be received by and coupled to the lead connector 30. As Figure 3A and Figure 3B As generally depicted by the arrows in FIGS. 6A and 6B, the lead 20 is fed into the lead connector 30 via the slot 62, funnel 71, or other guide. Once the lead 20 is received, the coupling can occur compressively by folding a portion of the structure using a screw, slide, lever, clasp, bayonet, magnet, clip, or other physical means that enables the user to couple the workpiece with only one hand. When folded or compressed, the lead connector 30 can be secured to the proximal end of the electrode 18 or lead 20. In some embodiments, the lead connector 30 can include a ratchet, vane, or other means to enhance the interference or friction to securely grip the lead 20. In some cases, the element that connects the lead connector 30 to the electrode 18 can also serve to remove unwanted insulation or coating from the surface of the proximal end of the electrode 18, thereby improving both the mechanical and electrical contact made by the lead connector 30. The lead connector 30 can secure the lead 20 in a manner that involves only one of the clinician and user with a single hand.

[0123] The present teachings can include designs that facilitate the use of the lead 20 and electrodes 18 for testing, a non-limiting example is a lead connector 30 that can quickly and efficiently electrically connect and operatively connect the proximal end of the lead 20 to the external stimulator housing 40 via a lead wire such as patient cable 50. The patient cable 50 can be of any suitable construction and can provide a secure / stable mechanical and / or electrical connection. This construction can reduce the duration of the procedure for installation on the patient. The ability to easily remove the lead connector 30 can also reduce the procedure time. Non-limiting examples can include a lead connector 30 that has a funnel end 71 so that the end of the lead 20 can be easily inserted into the funnel 71. The funnel 71 can guide the lead 20 into the lead connector area where a spring loaded tooth, ring or surface can be manipulated by the user via a lever or button to clamp onto and create an electrical connection with the lead 20. This lead connector 30 can have a lead wire and plug attached so that it can be connected with an external stimulator. The funnel 71 can make it easier to guide the small lead in. The funnel 71 can direct the proximal end of the lead to an area where a mechanical and electrical connection with the electrode can be made (e.g. by an internal clamp connection activated by an external control (e.g. a button, lever or other control connection means)).

[0124] Figure 3C An exemplary embodiment of a lead connector with a funnel end 71 is shown in FIG. 1. The funnel 71 can ease insertion of the proximal end of the lead (arrow pointing to where the end of the lead is to be inserted). The lead connector 30 can include a button 73 on the top portion of the lead connector 30 that is a non-limiting example of a mechanism through which the actual connection with the lead (internal, not shown) can be made / controlled. The patient cable 50 can be attached to the lead connector 50 in any suitable manner and can make it easy to connect to other components such as a stimulator housing 40.

[0125] The lead connector 30 can eliminate the need for a separate tool. It can make it possible to implement a one-handed mechanism for the clinician and / or patient, including but not limited to, it can include a push mechanism. The lead connector 30 can be of any suitable construction. By way of non-limiting example, the lead connector 30 can include a plastic unit (e.g. a plastic unit manufactured by insert molding) with an insulation displacement connector (IDC) mechanism that strips the insulation off the lead 20 to make electrical contact. The lead 20 can be placed in the slot 62 with a contact tab having a micro-structured barb that secures the lead 20 in place until the IDC mechanism is implemented with a one-handed push mechanism. The lead connector 30 can also be used to detach and reattach from (e.g. a magnet, spring or other mechanism) each time.

[0126] On the side of lead connector 30, a release mechanism 54 can be utilized. Release mechanism 54 can include a connector that allows for quick disassembly and easy re-attachment (e.g., a magnet or spring-loaded mechanism). However, the present teachings are not limited to this configuration. Release mechanism 54 can be operatively attached with patient cable 50 (i.e., the portion of lead 20 between the lead insertion site and stimulator housing 40). This can enable a mechanical and / or electrical connection to be established between lead 20 and patient cable 50 and / or stimulator housing 40. Release mechanism 54 can be any suitable configuration that exerts a predetermined force between lead connector 30 and one or more connection points between the portion of patient cable 50 and / or between patient cable 50 and stimulator housing 40. Release mechanism 54 can be configured such that when the predetermined force is exerted on patient cable 50, it becomes displaced from lead connector 30, another portion of patient cable 50 and / or stimulator housing 40. Release mechanism 54 can include a mechanical connection, an electrical connection, a magnetic connection or any combination of such connections (a detachable and re-attachable connection), including but not limited to a hook and loop system similar to Velcro. These can operatively interact to provide a predetermined clamping force such that when the amount of force exceeds this predetermined clamping force, release connector 54 releases. The present teachings are not limited to a particular configuration.

[0127] By way of non-limiting example, release mechanism 54 can use an insert molded neodymium magnet. In other embodiments, different permanent magnets can be utilized, such as samarium cobalt, alnico, ceramic, ferrite or other rare earth magnets. Additionally or in the alternative, a spring-loaded (or any biasing member) conductive pin (including but not limited to gold, gold plated, metallic or any other conductive material pin) connector can be disposed on patient cable 50 and a mating conductive element configured to operatively engage the conductive pin can be disposed on lead connector 30 body. The conductive pin can be formed of any conductive material, including but not limited to a generally flat gold plated contact material. The conductive pin can be of any configuration and the position relative to the mating conductive element can be adjusted.

[0128] This can provide the predetermined clamping force noted above. However, the present teachings are not limited to this configuration. A biasing member of any configuration can be used to exert a predetermined force between lead connector 30 and patient cable 50 (or in the alternative or additionally between portions of patient cable 50 and / or between patient cable 50 and stimulator housing 40).

[0129] The lead connector 30 can eliminate the need for a separate tool - it can utilize a one-handed push mechanism. Further, the lead connector 30 can include a release mechanism 54 of any suitable embodiment between the patient cables 50 and / or between the patient cables 50 and the stimulator housing 54. Still further, any number of release mechanisms 54 can be utilized, e.g., one, two, three, etc. Each such release mechanism 54 can be positioned on a different portion of the system, e.g., on the lead connector 30, on the patient cables 50 (any number can be utilized), and / or on the stimulator housing 40. Multiple release mechanisms 54 can be used to ensure that a release occurs no matter where force is applied.

[0130] The lead connector 30 can be configured such that the adhesive bandage 22 can be held secure during use (e.g., lock water and / or contaminants out), while also enabling safe and easy removal. The lead connector 30 and adhesive bandage 22 can be configured such that the adhesive bandage 22 can be replaced, applied, and / or reapplied while minimizing the risk of displacing or shifting the lead 20, lead connector 30, and / or any other system components. The lead connector 30 can be packaged with the adhesive bandage 22 to eliminate the need for multiple bands and to minimize the concern of lead shifting when performing a bandage change. In addition, the overall system can have a low profile, including by way of non-limiting example a low 30% profile. For example, the lead connector 30 can have a low profile that can help reduce the likelihood that a patient "catches" the lead connector 30 or inadvertently hooks the lead connector 30 on an object. Having a low profile can reduce the chance that this occurs. The lead connector 30 can have a profile that extends slightly more from the patient when attached to the patient, extends flush with the adhesive bandage 22, or extends slightly below the adhesive bandage 22.

[0131] Additionally or alternatively, the connector 30 can have a rotating element, such as a knob, dial, reel, or post. The rotating element can be mechanically and / or electrically engaged with the lead 20 in order to help adjust the tension of the detachable connection (e.g., release mechanism 54) having a tension created by the electrodes 18, lead connector 30, and patient cables 50. The rotating element can include a predetermined tension relief or retraction mechanism that responds to a breakaway force by releasing excess lead that is wound around the element. In the same manner, the lead connector 30 can achieve this tension relief by sliding or other movement that does not require rotation in nature. As with the detachable aspect of the patient cables 50, the tension relief can occur at a force that is less than or equal to one-half of the force required to displace or move the electrodes 18 from their initial position.

[0132] The lead connector 30 can be split or divided into multiple sections to accommodate multiple electrodes 20. For example, multiple slots or funnels can connect multiple electrodes to a single stimulator case 40 (or multiple stimulator cases 40) to enable therapeutic stimulation to be provided to separate portions of the body.

[0133] In other embodiments, the connection between the lead connector 30 and the patient cable 50 can be releasable - the releasability can be any suitable configuration, including but not limited to the disengagement mechanism 54. The releasability can include but is not limited to magnets that can be formed on one or both ends of the lead connector 50 as well as the patient cable 50 (if on both ends, the stimulator case 40 would also have a releasable connection as described herein), such as insert molded neodymium magnets. Depending on the manufacturing process, the magnets and how the magnets are assembled together can make the connection points distinguishable. For example, as shown, the lead connector 30 can have stepped connection ports that correspond to the stepped connection on one of the patient cables. Alternatively, round magnets can be placed on the top of the connector lead, also shown in Figure 4A Figure 4B A slight indentation or groove or other release force fit can be provided to make a "click in" feel can be experienced. In other embodiments, any mating shape can be utilized so that the patient or clinician can insert one portion into another portion or otherwise join the two components together - see, for example Figure 5 Furthermore, the present teachings are not limited to the shape and size of the magnets shown and disclosed. In these embodiments, any suitable shape or size of magnet can be utilized. The shape and size of the magnets can be the same mating shape or different shapes. Furthermore, the disengagement mechanism 54 can not utilize magnets, but can include any type, shape, and / or size of mechanical connection that releases from one another when a certain amount of force is applied. Regardless of the configuration, the disengagement mechanism 54 can reduce the risk of force on the patient cable 50 being transmitted to the lead 20 or more specifically the electrodes 18 that are inserted into the patient. The configuration can enable easy attachment and easy re-attachment.

[0134] ​In addition to or in place of magnets, a biasing mechanism can be utilized - such as a spring loaded member. The mechanism is generally described so that it can be used on any of the components described, but is expected to have particular utility at the connection between the lead connector 30 and the patient cable 50. The end A has an inverted Y shape that mates with a correspondingly shaped end B. Additional shapes, prongs, or members can be included. The outermost arms C move, such as spring loaded or magnetically, to accommodate and release the end A (single ended arrow indicates the preferred range of motion). The ends A and B can mate in a plane parallel to the double arrow, and / or they can drop into place or snap into place, and then release in a direction different from the release direction (preferably including perpendicular to the release direction).

[0135] In some embodiments, the disengagement mechanism 54 can be configured so that if an unwanted force is applied to the stimulator housing 40 and the lead 20 (or more specifically, the electrode 18) or their connection(s), neither is dislodged. For example, the connection between the patient cable 50 and the stimulator housing 40 is detachable upon the application of a predetermined force. The predetermined force can be calculated to substantially prevent the electrode 18 from moving once it has been placed in the proper position within the patient.

[0136] Alternatively or additionally, the patient cable 50 itself can be detachable (e.g., detachable in the middle so that it is effectively multiple patient cables, e.g., 2 or more). The patient cable 50 can be detachable at any point between the lead 20 and the stimulator housing 40, for example, the patient cable 50 can be broken at either end. Still further, the predetermined detachable portion can be between the patient cable 50 and the stimulator housing 40, anywhere along the length of the patient cable 50. For example, two or more patient cables 50 can be selectively attached at a detachable point to break apart upon the application of a predetermined force. Further, while the disclosure indicates that the portion is detachable, they can also be attachable. This can make the system useful as a failsafe mechanism to prevent injury and / or harm to the system, components, and / or the patient. The detachable portion can include the disengagement mechanism 54 described above or any other kind of suitable detachable member.

[0137] In addition to simply safely disconnecting, the circuitry in any of the patient cable 50, lead connector 30, and / or stimulator housing 40 can prevent delivery of unwanted stimulation in the event of a disconnection during stimulation, such as when multiple leads and / or patient cables can be utilized. By way of non-limiting example, the patient cable 50 can be a "smart cable" that, in addition to serving as a path for electrical conduction, has components that minimize the risk of a patient experiencing unwanted stimulation when the patient cable 50 is accidentally disconnected during use (e.g., minimizes or eliminates the possibility of a patient experiencing a shock). For example, the patient cable 50 can prevent further stimulation when disconnected from either of the lead connector 30 and / or stimulator housing 40.

[0138] The above-mentioned connections all rely on mating parts. To avoid improper installation, each mating pair can be given a unique shape. Sensors or other circuitry can be used at the connection points to better enhance the user warning features described herein. Such sensors or circuitry can be inherent to the electrical signals that deliver stimulation, or separate signals can be established.

[0139] The patient cable 50 can mechanically and / or electrically connect the lead connector 30 and the controller housing 40. Any durable, flexible material can be used for the patient cable 50. The patient cable 50 can also deliver power to and / or from the connected elements, or a separate power source can be provided. The power source for the system 10, and in particular the stimulator housing 40 and the controller housing 60, can be disposable or rechargeable, and any number of batteries or other power devices (e.g., capacitors, fuel cells, etc.) can be incorporated, depending on the form factor and power requirements of the system.

[0140] In the event that multiple patient cables 50 are used to establish a connection between the electrode / lead connector 30 and the stimulator housing 40, each segment of the patient cable 50 can rely on the quick release connection described above. In this manner, the risk of an accidental force (e.g., a snag on clothing) repositioning or dislodging the electrode 18 is further minimized, particularly if the stimulator housing 40 cannot be placed adjacent to the lead connector 30. Utilizing multiple segments in the patient cable 50 also improves the overall adaptability of the system.

[0141] The housing and / or materials selected for the lead connector 30 should be consistent with its design and purpose. At least portions of the lead connector 30 will be constructed of a material that is sufficiently conductive to carry electrical pulses and signals from the stimulator housing 40 (such as via the patient cable 50). Magnetic shielding can be selectively used to minimize the creation of unwanted magnetic fields.

[0142] In Figure 2AIn the depicted embodiment, lead connector 30 can be attached to body 12. This attachment can be made with adhesive, straps, or other means. In one embodiment, at least a portion of lead connector 30 is engaged by adhesive tape bandage 22. Lead connector 30 can be sufficiently lightweight and / or located sufficiently proximate other system components secured to body 12 such that lead connector 30 can be simply and freely moved as part of a detachable connection having tension formed by electrodes 18, lead connector 30, and patient cable 50. As shown, temporary band 61 can be used to hold lead connector 30 in place for operative attachment of release mechanism 54. In some embodiments, temporary band 61 can not be utilized. Figure 6

[0143] Stimulator housing 40 can contain a programmable memory unit as well as the circuitry necessary to deliver the therapeutic stimulation inherent to system 10. In addition, stimulator housing 40 can be designed to eliminate the need for a separate return electrode. Stimulator housing 40 can also contain a graphical user interface to communicate with the user. Stimulator housing 40 can include LEDs or other visual indicia to convey action, error, or other pertinent information about the operation of the system. Stimulator housing 40 can also allow for user and / or clinician adjustment of the operation of the system. Still further, stimulator housing 40 can communicate with controller unit via a physical or wireless connection. Cables, wires, Bluetooth, and other wireless technologies are all expressly contemplated. In some embodiments, controller housing 60 can or can not have a user interface integrated with it and / or remote (e.g., wireless, such as Bluetooth). The present teachings are not limited to any such configuration.

[0144] Controller housing 60 can provide a more extensive graphical user interface, and it can be the primary means of initiating and changing therapy, however, the present teachings are not so limited. Like stimulator housing 40, controller housing 60 can communicate with stimulator housing 40 (or multiple housings, if multiple housings are included in the system) and optional programmer unit 70 via physical wires / cables or wirelessly. Controller housing 60 can be relatively larger than stimulator housing 40, but wireless connections can allow the user to carry controller housing 60 in clothing and / or generally at a convenient distance and location compared to electrodes 18 and stimulator housing 40.

[0145] ​While both stimulator housing 40 and controller housing 60 can have low profile and lightweight features, programmer unit 70 can be a fully capable computer that can transmit detailed therapy instructions / protocols, error logs, usage logs, and / or other information generated by system 10. In some embodiments, programmer unit 70 can remain in the possession of a clinician, as it is capable of a wider range of therapies, and the mobility and portability aspects of the other components of system 10 are inherent to the user. Programmer unit 70 can communicate with stimulator housing 40, either directly or indirectly via controller housing 60.

[0146] By way of example, and not limitation, system 10 is contemplated to have particular utility for treating post-stroke shoulder pain by percutaneous stimulation in the deltoid muscle via a thin wire lead to stimulate a branch of the axillary nerve. The therapy is delivered for a period of time, after which the lead is removed using gentle traction. The duration of the daily therapy can range between 1 hour and 12 hours, with 6 hours being a preferred duration. The daily therapy can be given for a period of days, weeks, or even months, with 30 days being contemplated to have the greatest benefit. The stimulation pulses and parameters can vary, but a preferred range is less than 25 Hz, with some therapies being particularly effective in ranges bounded by separate lower and upper limits selected from the following values: 1, 5, 10, 12, 15, 18, and 20, although other limits are contemplated. The amplitude is preferably centered around 20 mA, but any value up to 50 mA or more can be useful. The pulse duration lasts from 5 microseconds to 200 microseconds or more, with a minimum average pulse duration of 32 μβ (range: 5 μβ - 75 μβ); an optimal average pulse duration of 70 μβ (range: 10 μβ - 150 μβ); and a maximum allowable average pulse duration of 114 μβ (range: 25 μβ - 200 μβ). In particular, testing has shown that the electrical stimulation according to system 10 for this purpose has both short-term and long-term benefits that are not adequately achieved by alternative treatment methods noted above.

[0147] While the post-stroke shoulder pain application is described above, the present teachings are not limited to any particular treatment or indication. It can be applicable to any kind of treatment, including but not limited to post-operative pain patients or any type of pain patients, particularly chronic pain patients (e.g., neuropathic pain, headache, and / or back pain patients).

[0148] Additional embodiments of the transcutaneous stimulation system according to the present teachings are described below. In the description, not all details and components can be fully described or shown. Rather, the main features or components are described, and in some cases, differences from the above-described embodiments can be noted. Also, it should be appreciated that these additional embodiments can include elements or components used in the above-described embodiments, but not shown or described. Thus, the description of these additional embodiments is merely exemplary, and not all inclusive, nor exclusive. Also, it should be appreciated that features, components, elements, and functions of the various embodiments can be combined or altered to achieve a desired transcutaneous stimulation system without departing from the spirit and scope of the present invention.

[0149] The lead connector 130 can be designed to easily couple to the transcutaneous lead. In a non-limiting example, the lead can be inserted through a bore 131 in the lead connector, and the lead can be partially or completely through the bore 131. The bore 131 can include a funnel shape in which the lead is inserted to enable easy insertion into the bore - see Figure 12 In another non-limiting example, the lead can be placed within a slot or channel in the lead connector 130. In another non-limiting example, the lead connector can be composed of two or more components, with the lead being placed between and / or within the components, and the components can be secured together (e.g., slid together, snapped into place, twisted / wrung around each other, etc.) to couple to the lead. In some embodiments, the lead connector 130 can enable easy one-handed insertion and coupling of the lead to the system while maintaining mechanical and electrical security, and prevent the patient from intentionally or unintentionally unhooking the lead (or electrodes).

[0150] The lead can be electrically and mechanically coupled to the lead connector. The mechanism by which the lead is mechanically coupled to the lead connector 130 can be separate from, or the same as, the mechanism by which the lead is electrically coupled to the lead connector 130. The user can use to couple the lead to the lead connector 130 include, but are not limited to, a knob, a button, a switch, or a dial.

[0151] The lead connector 130 can be uncoupled from the lead and can enable the lead to be reconnected to the lead connector 130 at different points along the lead (e.g., closer or further from the stimulating portion of the lead or electrode). In a non-limiting example, the lead connector 130 can include a lock that prevents the patient from uncoupling the lead. The lock can be opened using, for example, but not limited to, a key, a tool (e.g., a torque wrench), a code (e.g., combination), or without a tool. In another non-limiting example, the lead connector 130 can minimize or eliminate damage or alteration to the structure of the lead, enabling the lead to remain sufficiently intact to substantially reduce the risk of the lead breaking or fracturing, and enabling current to flow through the entire lead.

[0152] The lead connector 230 can include a lead storage mechanism 233 that stores the lead 220 (e.g., while the lead is coupled to the lead connector 230). The mechanism can shorten the excess length of the lead 220 between the lead connector 230 and the point at which the lead 220 exits the body from. This can reduce the risk of the lead 220 snagging on objects and being pulled and / or fractured. If the lead 220 is snagged, for example, on an external object or by a body part, the excess lead 220 stored on the mechanism can be released, rather than displacing or moving the lead 220 from the tissue, fracturing the lead 220 (inside or outside the body), and / or pulling the lead 220 out of the lead connector 230 and uncoupling the lead 220 from the lead connector 230. In a non-limiting example, the mechanism 233 can be a spool around which the lead 220 is manually or automatically (e.g., using a spring) wound. In another non-limiting example, the mechanism 233 can be disposed outside or within the lead connector 230 - see Figure 13 and Figure 14 Additionally, the lead connector 230 can be padded on one or more sides to provide comfort when wearing the lead connector 230.

[0153] Lead connector 330 can be designed to easily couple to the stimulator housing 40 and can enable connection using a single hand. In a non-limiting example, lead connector 330 can be connected to the stimulator housing 40 via a patient cable 350. In a non-limiting example, patient cable 350 can be connected to lead connector 330 by a connection 357, such as a magnetic connection by way of a non-limiting example. However, it should be understood that while a magnetic connection is described, the connection can be any mechanical connection other than or in addition to a magnetic connection. Connection 357 can be oriented at various angles relative to the surface of the skin. In a non-limiting example, connection 357 is oriented substantially perpendicular to the skin. In another non-limiting example, connection 357 is oriented substantially parallel to the surface of the skin. In yet another embodiment, connection 357 can be easily accessible for the user to establish (e.g., does not require dexterity, can be connected without looking at the connector, etc.) and strong enough to prevent inadvertent disconnection (e.g., due to ordinary body movement or small forces, etc.) when subjected to stronger forces that can dislodge the lead (e.g., forces from external objects or body parts pulling or tugging on the lead connector or stimulator attached to the lead connector). Connection 357 can prevent dislodgement or breakage of lead 320 by breaking the lead connector 330 and cable when the patient cable 350 is pulled, rather than transmitting the force along the lead 320 - see Figure 15 and Figure 16 In some embodiments, connector 357 can include two portions of a magnet that attract each other under a predetermined force, a positive portion 357a and a negative portion 357b. It should be understood that the positive portion can be on one of sides 357a or 357b and the negative portion can be on one of sides 357a and 357b. Further, one portion can be a magnet (357a or 357b) and the other side can be a material that is attracted to the magnet (357a or 357b). In a non-limiting example, magnetic connector 330 can be constructed such that the surrounding magnetic field is reduced and interference with objects placed near the magnetic connector (e.g., credit cards, cellular phones) is avoided.

[0154] Further, lead 320 can be directly connected to the stimulator housing 40 (i.e., the lead connector can be built into or integrated with the stimulator housing). The stimulator housing can be placed directly over or near the lead exit portion to protect the exit site. There can be a transparent window through which the lead exit portion can be monitored for safety (e.g., infection, inflammation).

[0155] In another non-limiting example, patient cable 450 can be connected to lead connector 430 using socket 457b and plug 457a, and socket 457b can be mounted on patient cable 450 and oriented at an angle (such as 90 degrees) relative to patient cable 450. Socket 457b can be connected to plug 457a on lead connector 430 using a downward force, such that the connection can be made using a single hand. The very small distance between the magnetic armature of plug 457a and the permanent magnet structure of lead connector 430 means that the residual field outside of lead connector 430 is very small - see Figure 16 .

[0156] As shown in Figure 17 , patient cable 550 can be attached to the stimulator and stowed or organized (e.g., wound, crimped, coiled) to shorten the length of patient cable 550 (or lead 520) that can become hooked on, for example, external objects or body parts. In a non-limiting example, excess patient cable 550 can be stowed in a stow device 551 attached to cable 550 on lead connector 530 and / or on stimulator housing 540. In a non-limiting example, stow device 551 is a spool around which patient cable 550 can be wound, either manually or automatically (e.g., via a spring). In an embodiment, patient cable 550 can be crimped or coiled around a spool on stimulator housing 540, and forces on patient cable 550 cause patient cable 550 to unspool from the spool rather than disconnect from stimulator housing 540, transmitting the forces to lead connector 530 and / or patient cable 550 - see Figure 17 .

[0157] A stimulation system can include multiple lengths of patient cable attached to the stimulator housing. In a non-limiting example, the patient cable with the shortest length that enables connection between the stimulator housing and the lead connector can be selected to reduce the risk of the patient cable hooking on objects or body parts and causing the system to disconnect, the lead to dislodge, and / or the lead to break.

[0158] As shown in Figure 18As shown, two or more patient cables 650 can be used to connect the stimulator housing 640 to the lead connector 630. The use of more than one patient cable 650 connected to the stimulator housing 640 can enable more control over the total length of the wiring between the lead connector 630 and the stimulator housing 640 (e.g., as compared to the use of a single cable having a fixed length). In a non-limiting example, each patient cable 650 can be very short (e.g., <1-2 inches), which can enable more precise control over the total length of the multiple cables connected together. In another non-limiting example, the patient cables 650 can be used in different lengths. In a non-limiting example, the multiple patient cables 650 can be connected together, and the minimum number of cables used to connect the lead connector 630 to the stimulator housing 640 to minimize the total length of the cables, thereby reducing the risk of the cables catching or tangling on (e.g., external objects or body parts) - see Figure 17 Each patient cable 650 can be attached with a breakaway mechanism 654 of any configuration, such as the configuration described above. Each patient cable 650 can include a breakaway mechanism 654 attached to each end thereof. The breakaway mechanisms 654 can be connected to each other and / or to the lead connector 630 and / or the stimulator housing 640 such that they remain connected upon the application of a predetermined force. If a force is applied that exceeds the predetermined force, any of the multiple breakaway connectors 654 can become disconnected. This prevents the electrodes from moving from within the patient. The breakaway connectors 654 can also be easily attached once they have become disconnected. The breakaway connectors 654 can be connected together with magnets, bayonet attachments, biasing forces, friction fits, etc. Any suitable configuration can be utilized.

[0159] In some embodiments, the stimulator housing can enable coordination of stimulation on two or more stimulator housings. In the alternative or additionally, the controller housing and / or the programmer unit can enable coordination of stimulation on two or more stimulator housings. The coordinated stimulation can enable the stimulation on multiple stimulator housings to start and stop in a coordinated manner to avoid asynchronous activation of muscles on opposite sides of the body (e.g., back or torso), which can cause loss of balance or discomfort. Control of the stimulation on multiple stimulator housings can also prevent simultaneous stimulation, for example, to avoid activation of opposing muscles (e.g., bicep and tricep), which can cause discomfort. In a non-limiting example, one of the stimulator housing, controller, and / or programmer unit can communicate directly with the other stimulator housings. In another non-limiting example, each stimulator housing can be connected to a central control unit, which can be another stimulator housing or can be a non-stimulating control unit. In a non-limiting example, the communication between the stimulator housings and / or the control unit (controller housing or programmer unit) can be wireless (e.g., via Bluetooth, WI-Fi) or wired (e.g., cable).

[0160] The stimulator housing can provide simple programming of stimulation intensity by controlling the stimulation amplitude and pulse duration with a single programmable parameter regarding intensity. Stimulation intensity is determined by multiple parameters, including, but not limited to, stimulation amplitude and pulse duration. For example, stimulation intensity can be increased by increasing the stimulation amplitude, pulse duration, or a combination of both. Using a single parameter to control multiple parameters, such as stimulation amplitude and pulse duration, can reduce the complexity of the process of programming the stimulation parameters by reducing the number of parameters, which can change from 2 or more to 1. As a non-limiting example, a minimum value of the stimulation intensity parameter (e.g., 0) can set the stimulation amplitude and pulse duration to their minimum values (e.g., 0.2 mA and 10 microseconds). As another non-limiting example, increasing the stimulation intensity parameter can change the stimulation amplitude, pulse duration, or both.

[0161] In yet another embodiment, increasing the stimulation intensity parameter from a minimum value can first increase the stimulation amplitude while keeping the pulse duration at a minimum until a maximum value of the stimulation amplitude is reached (e.g., 20-30 mA). Then, continuing to increase the stimulation intensity parameter beyond the maximum value of the pulse duration (e.g., 200 microseconds) can keep the stimulation amplitude fixed at the maximum value while increasing the pulse duration until a maximum value of the pulse duration is reached. In this example, the stimulation intensity is increased while keeping the stimulation amplitude as low as possible, which keeps the power consumption of the pulse as low as possible for a given charge per pulse. Figure 19 The left column of Table 1 is a first example of keeping the pulse duration low. Figure 19 The right column of Table 1 is a second example of keeping the stimulation amplitude low.

[0162] In another non-limiting example, a lead connector can be attached to the lead before or after the introducer system is inserted so that stimulation through the lead tip is possible during the lead placement procedure. In one embodiment, the connector can be attached to the lead by lowering the lead into a slot or hole on the block and closing flaps that effectuate insulation displacement connections (e.g., cutting through the insulation material next to it to make a connection with the conductive lead wire). This lead connector can improve the speed and ease of lead connection because it can be attached without tools (e.g., no wire cutters, scissors, and screwdrivers). For example, in this embodiment, the lead can be placed into a slot in the lead connector block and secured using a lockable, reversible hand tool to displace the insulation material on the lead body. The insulation displacement mechanism inside the lead connector can also cut the lead distal to the electrical connection. Once the connection has been made and excess lead is cut off, a lock (e.g., slide, twist, button press) can ensure that the flaps on the block cannot be accidentally reopened. This feature prevents a loss of connection between the lead connector and the lead, which would result in a loss of therapeutic benefit. The lead connector can be mated with another lead connector (e.g., patient cable or plug that plugs into the stimulator case) to complete the circuit from the stimulator case to the lead tip electrodes.

[0163] In one embodiment, the connection between the two lead connectors can be magnetic. In this case, the shape of the lead connector will prevent the lead connectors (e.g., lead connectors that fit together in only one orientation) from being improperly aligned. The magnetic connection can be used for both temporary stimulation delivery and permanent stimulation delivery (e.g., during the lead placement procedure or during patient use of therapy at home). After the proper lead placement position is obtained, the lead connector block can be removed and replaced after the introducer system needle(s) and sheath(s) are removed. In one embodiment, the connection can be deactivated by pressing or sliding open a slot containing the lead. In this example, the lead connector block can be removed or cut off before the introducer is removed and then quickly reattached to a more proximal location on the lead. After the introducer is removed, the lead can be placed in the slot and connected with a one-touch mechanism (e.g., press, slide) and then the lead connector can be attached to the stimulator cable.

[0164] The magnetic connection can act as a quick release connection that will prevent accidental displacement of the lead (or electrodes) due to the lead and / or patient cable being pulled. Rather than transmitting force to the lead exit site and lead, any force on the patient cable will be released due to the magnetic connection between the patient cable and the lead connector block being broken. If the clinician desires, a permanent connection can be established by locking the two connector pieces together using a button lock (or any other suitable lock). In addition to mating with the lead connector block, in another embodiment, a magnetic cable connector for the stimulator case can also mate with the same variant of the lead connector block that connects to the test stimulator via cable. In another embodiment, the magnetic cable connector from the stimulator case can be split into two pieces to connect with multiple lead connector blocks (e.g., to enable stimulation of two leads with one stimulator).

[0165] A battery-operated, body-worn stimulator case can generate a current that can be delivered via a lead and / or introducer. In one embodiment, the stimulator case is a small case (e.g., with a circular profile and minimal profile height) that is worn on the body via gel patch electrodes that serve as return electrodes and are connected with two snap connections that also provide electrical connections. In one embodiment, the stimulation case has minimal user interface (e.g., button start / stop, LED light, and speaker or buzzer) that provides critical feedback to the patient. For example, the light can flash or light up (e.g., different color or different flashing pattern) if the battery is low or if there is a stimulation problem. This important feedback will alert the patient or clinician to resolve any issues such as battery failure, gel pad dislodged, or disconnected connections. In the non-limiting example with magnetic lead connectors, it is important that the stimulator case generates a warning if the quick release cable is accidentally displaced without the patient knowing. Additionally, lead errors that cause stimulation to stop due to, for example, high electrode impedance problems (e.g., due to loss of connection between the skin and the return electrode) can impact the treatment use time and treatment benefit received by the patient, and the audible or visual warning of the stimulator case prevents this. Furthermore, in one embodiment, the stimulator memory will generate an activity log for providing documentation of the stimulator's use and errors during therapy. The stimulator log can include a list of errors that occurred, along with a timestamp of when the error occurred, a history of use time (including the amplitude and stimulation parameter settings used). These features are important to ensure that the patient is able to use the stimulation effectively and that the clinician can monitor their stimulation use effectively.

[0166] Figure 20 and Figure 21 An exemplary embodiment of an IDC is depicted in FIG. 7. Figure 20 The illustrated IDC 705 can include a drawer-type mechanism or tray 708 that can be inserted into and removed from the body of the IDC 705. A slot 710 that securely grips or engages the lead 720 of any suitable shape and size can be positioned within the tray 708. A user can push the tray 708 to cause the tray to rotate and move the lead 720 entirely within the IDC 705. The IDC can be integral with the lead connector or can be attached to the lead connector. If necessary, a barb (not shown) can be included inside the IDC 705 to remove the insulating material from the lead 720 to expose the underlying wire.

[0167] In Figure 21In another embodiment shown, IDC 805 may have a generally cylindrical shape. IDC may include a aperture, slot, or opening 807 through which leads 820 can be inserted. IDC may include an actuating lever that rotates IDC until leads 820 are fully inside IDC. If necessary, barbs (not shown) may be included inside IDC 805 to remove insulation from leads 820 to expose the underlying wires.

[0168] Figures 22-25 Another embodiment of the disengagement mechanism 954 is shown. Figure 22 In the diagram, a portion of the disengagement mechanism 954 is shown as a receiver portion 956. The receiver portion 956 may include a magnet 958 including a contact point 959, according to any suitable embodiment. The receiver portion 956 may include a ferromagnetic stator 960, which may act as a path holder. Figure 23 The diagram depicts a component of the disengagement mechanism 954, namely a plug 962. The plug 962 may include a ferromagnetic retainer path 964 and a contact 966. The patient cable 950 may be operatively attached to the plug 962.

[0169] like Figure 24 As shown, the disengagement mechanism 954 may include a spring-loaded piston mechanism 974. The piston mechanism 974 utilizes a pair of biasing members 977 that push pistons 975 against each other when the plug 962 is inserted into the receiver 956. This secures the disengagement mechanism 954 together. The force used to hold the disengagement mechanism 954 together is defined as any amount of force applied to the system exceeding such a force will disengage the plug 962 from the receiver 956, for example, if a force is applied to the patient cable 950 due to it being caught on something. This will substantially protect the system. Specifically, it substantially prevents the leads and / or electrodes from becoming displaced or moving from their intended positions.

[0170] Although embodiments of the teachings have been illustrated in the accompanying drawings and described in the foregoing detailed description, it is to be understood that the teachings are not limited to the disclosed embodiments, but rather that the teachings described herein can be rearranged, modified, and substituted in many ways without departing from the scope of the claims.

Claims

1. A combination of a lead connector and a lead for a transcutaneous electrical stimulator system, the combination comprising: A lead connector comprising a body having at least one slot or channel; a stimulating electrode of a percutaneous coiled lead inserted into the slot or channel, wherein the stimulating electrode has an engagement force when inserted into a patient's body; wherein the lead connector further comprises a contact element proximate to at least a portion of the slot or channel to establish electrical contact with the percutaneous coiled lead; a patient cable optionally attached to the body; wherein the contact element further establishes an electrical connection with the patient cable; and wherein the lead connector further comprises a disengagement mechanism that allows the body to be selectively disconnected from the patient cable upon application of a force that exceeds a predetermined force, wherein the predetermined force is less than the engagement force.

2. The combination of claim 1, wherein, The contact element comprises a microstructured barb for engaging the lead.

3. The combination of claim 1, wherein, The disengagement mechanism comprises a Velcro hook and loop attachment.

4. The combination of claim 1, wherein, The disengagement mechanism comprises a neodymium magnet.

5. The combination of claim 1, wherein, The disengagement mechanism comprises at least one of a rare earth magnet, a samarium cobalt magnet, an alnico magnet, a ceramic magnet, and a ferrite magnet.

6. The combination of claim 1, further comprising an insulative displacement device proximate to the slot or channel that engages the percutaneous coiled lead to remove any electrical insulating material therefrom upon or after insertion of the percutaneous coiled lead into the slot or channel.

7. The combination of claim 6, wherein, The contact element comprises a microstructured barb to temporarily engage the percutaneous coiled lead upon or before removal of electrical insulating material from the percutaneous coiled lead.

8. The combination of claim 1, wherein, A spring-loaded conductive pin carried on the patient cable engages a mating element formed on the body, the engagement of the mating element with the patient cable forming an electrical connection between the percutaneous coiled lead and the patient cable through the contact element.

9. The combination of claim 1, wherein, A spring-loaded conductive pin formed on an outer surface of the body engages a mating element formed on the patient cable, the engagement of the conductive pin with the patient cable forming an electrical connection between the percutaneous coiled lead and the patient cable through the contact element.

10. The combination of claim 1, further comprising an adhesive bandage that cooperates with the body.

11. The combination of claim 10, wherein, The profile of the body is the same as or lower than the thickness of the adhesive bandage.

12. The combination of claim 1, wherein, The body comprises a connection point for attachment to the patient cable.

13. The combination of claim 12, wherein, The connection point has an inverted Y shape.

14. The combination of claim 12, wherein, The connection point has a plurality of moveable arms.

15. The combination of claim 12, wherein, The connection point has a biased fitting.

16. The combination of claim 1, wherein, The body has a stepped shape.

17. The combination of claim 1, wherein, The body comprises a releasable force fitting comprising a groove or recess.

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