Stimulation lead connection system

Abstract

A lead connector system for use with an electrical nerve stimulator is described herein. An example lead connector for an electrical stimulator system includes a body, a blade, and an insert. The body includes a cable interface and defines a lead port. The blade is attached to the body. The blade has at least one angled portion. The insert is slidably connected to the body. The insert includes a handle and a chassis. The chassis defines a lead channel coaxial with the lead port, and the blade channel traverses the lead channel to receive the blade. The angled portion of the blade provides electrical contact between the cable interface and a lead inserted into the lead channel and extending through at least one of the lead ports.

Description

[0001] Related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 989,129, filed on March 13, 2020, which is incorporated by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to electrical nerve stimulators and, more particularly, to lead connector systems for use with such stimulators. Background Art

[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 can only be performed in a clinical setting under the supervision of a clinician, limiting applicable uses and the time available for stimulation. Furthermore, by today's standards, the controllers used in these clinical settings are relatively large and difficult to operate and transport.

[0005] There are both external and implantable devices for providing neurostimulation in a variety of therapeutic and functional restoration indications. These neurostimulators are capable of providing treatment to various parts of the body. The operation of these devices generally 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 one or more percutaneous leads having one or more electrodes are used to deliver electrical stimulation to one or more selected parts of the patient's body.

[0006] For example, transcutaneous electrical nerve stimulation ("TENS") is delivered through electrodes placed on the surface of the skin, but has not achieved widespread use due to discomfort, muscle fatigue, and limited efficacy of the treatment. TENS is similar to electrical muscle stimulation, although the latter is designed to stimulate muscles rather than nerves.

[0007] Several clinical and technical issues associated with surface electrical stimulation have prevented it from becoming a widely accepted treatment method. First, stimulation of skin pain receptors cannot be avoided, resulting in stimulation-induced pain, which limits patient tolerance and compliance. Second, electrical stimulation is delivered at a relatively high frequency to prevent stimulation-induced pain, which can lead to an early onset of muscle fatigue. Third, it is difficult to stimulate deep nerves with surface electrodes without stimulating overlying, more superficial nerves, resulting in unwanted stimulation. Furthermore, clinical skills and intensive patient training are required to reliably place the surface electrodes and adjust the stimulation parameters on a daily basis to provide optimal treatment. The required daily maintenance and adjustments of surface electrical stimulation systems are a major burden for both patients and caregivers.

[0008] Many previous systems for spinal cord stimulation (e.g., at the dorsal root ganglia) and / or other deep tissue stimulation require surgical implantation of electrodes and / or other devices for delivering the therapy. These treatments necessarily incur the costs and medical risks associated with invasive surgical procedures, and they can limit the patient's mobility, both in terms of the surgical procedure itself and, in some cases, in postoperative activities that an outpatient patient may wish to participate in within his or her home environment.

[0009] For example, U.S. Patent 7,376,467 discloses a neuromuscular stimulation assembly that includes a steerable introducer defining an inner cavity that protects the electrode from contact with tissue during insertion. Electrodes suitable for use with the assembly can be transcutaneous or percutaneous. The assembly includes a carrier that is adhered to the patient, an electronics compartment for generating a desired current pattern, and an optional power input compartment that enables replacement of batteries for the assembly. Electrical connection between the electrode and the power supply is established via a slot integrally formed on the compartment.

[0010] As another example, U.S. Patent 8,700,177 describes a system and method that involves the use of an adhesive patch with a mounting structure that mates directly with 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 via a plug connection. A rechargeable battery powers the device, which can be charged inductively.

[0011] One of the problems associated with such transcutaneous systems is lead dislodgment. This often occurs when a user or clinician attempts to remove the bandage surrounding the lead. In this situation, the bandage's adhesive can adhere to the lead and inadvertently dislodge it. Specifically, when the user or clinician tears off the bandage, it often sticks to the lead, and when the bandage is removed from the user's skin, the lead remains adhered to the bandage and is inadvertently removed. Therefore, a system is needed to prevent this from happening. Summary of the Invention

[0012] A lead connector system for use with an electrical nerve stimulation device is disclosed. The connector system includes, for example, an electrically passive connector base, a connector that serves as an interface between a cable and a lead, a lead anchor that promotes lead stability, and / or a cover that protects the connector and / or the lead. In some examples, the connector base is adhered to the patient's skin to removably connect the connector to the patient. The connector includes (a) a receiving port, in some examples, in different sides of the connector to receive a lead and an extension cable, and (b) a blade-like interface that establishes and maintains electrical contact between the lead and the cable. The lead anchor is configured to adhere to the lead and the patient relatively close to the location where the lead enters the skin to prevent movement of the lead. The protective cover can be configured to form a barrier around the connector and the lead.

[0013] A lead connector system for use with an electrical nerve stimulator is described herein. An example lead connector for an electrical stimulator system includes a body, a blade, and an insert. The body includes a cable interface and defines a lead port. The blade is attached to the body. The blade has at least one angled portion. The insert is slidably connected to the body. The insert includes a handle and a chassis. The chassis defines a lead channel coaxial with the lead port, and the blade channel traverses the lead channel to receive the blade. The angled portion of the blade provides electrical contact between the cable interface and a lead inserted into the lead channel and extending through at least one lead port.

[0014] An example lead connector for an electrical stimulator system includes a base, one or more blades, and a cover. The base includes a cable interface and defines a lead port. The blade is attached to the body. The blade has at least two sections that intersect an axis defined by the lead port. The cover is rotatably connected to the base. The cover includes a handle, a blade guide, and a lead guide. The blade guide defines a blade channel, each blade channel interfacing with a different one of the blade's sections. A portion of each blade section provides electrical contact between the cable interface and a lead inserted into at least one lead port.

[0015] The stimulation lead connection system includes a cable, a lead connector, and a connector base. The cable includes a magnetic breakaway connection at a proximal end, a head at a distal end, and may include an additional magnetic breakaway connection at the distal end. The lead connector is electrically connected and mechanically docked with the head, and is electrically connected and mechanically docked with a lead that is at least partially covered with an insulation layer. The connector base selectively receives the lead connector. The connector base includes an adhesive pad configured to adhere to the patient's skin.

[0016] These and other features and advantages of the present disclosure are set forth in the following description, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The operation of the present disclosure may be better understood by reference to the following detailed description taken in connection with the following drawings, in which:

[0018] Figure 1 An example connector and an adhesive layer for engagement between a patient's skin and the connector are shown in accordance with the teachings of the present disclosure.

[0019] Figure 2 An example connector that is slidably lockable with a connector base according to the teachings of the present disclosure is shown.

[0020] Figure 3A 、 Figure 3B and Figure 3C Another example connector slidably engageable with a connector base according to the teachings of the present disclosure is shown.

[0021] Figure 4A 、 Figure 4B 、 Figure 4C 、 Figure 4D and Figure 4E An example connector is shown that is vertically lockable with a connector base according to the teachings of the present disclosure.

[0022] Figure 5A and Figure 5B A molded connector housing configured to receive a connector in accordance with the teachings of the present disclosure is shown.

[0023] Figure 6A 、 Figure 6B 、 Figure 6C 、 Figure 6D 、 Figure 6E and Figure 6F An example connector with a detachable cable in accordance with the teachings of the present disclosure is shown.

[0024] Figure 7A 、 Figure 7B 、 Figure 7C and Figure 7D An example push-to-lock connector according to the teachings of the present disclosure is shown.

[0025] Figure 8A 、 Figure 8B and Figure 8C An example foldable lead anchor in accordance with the teachings of the present disclosure is shown.

[0026] Figure 9A and Figure 9B An example snap-on lead anchor in accordance with the teachings of the present disclosure is shown.

[0027] Figure 10A 、 Figure 10B 、 Figure 10C and Figure 10DAn example foldable lead anchor in accordance with the teachings of the present disclosure is shown.

[0028] Figure 11A and Figure 11B An example adhesive-based lead anchor in accordance with the teachings of the present disclosure is shown.

[0029] Figure 12A and Figure 12B Another example of an adhesive-based lead anchor according to the teachings of the present disclosure is shown.

[0030] Figure 13 An example dual-purpose lead anchor in accordance with the teachings of the present disclosure is shown.

[0031] Figure 14 An example protective cover according to the teachings of the present disclosure is shown.

[0032] Figure 15A and Figure 15B Another example of a protective cover according to the teachings of the present disclosure is shown.

[0033] Figure 16A and Figure 16B An example of a protective cover configured to retain cables outside the protective cover in accordance with the teachings of the present disclosure is shown.

[0034] Figure 17A 、 Figure 17B 、 Figure 17C and Figure 17D Shown are cables with magnetic leads and connectors with corresponding magnetic brackets in accordance with the teachings of the present disclosure.

[0035] Figure 18A and Figure 18B A cable having a magnetic head and a connector having a corresponding magnetic bracket are shown, along with a protective cover configured to retain the head of the cable outside the protective cover in accordance with the teachings of the present disclosure.

[0036] Figure 19A 、 Figure 19B and Figure 19C A cable having a magnetic head and a connector having a corresponding magnetic bracket are shown, along with another example of a protective cover configured to retain the head of the cable outside the protective cover in accordance with the teachings of the present disclosure.

[0037] Figure 20A 、 Figure 20B and Figure 20C Shown are a cable with an interlocking head and a connector with a corresponding magnetic bracket in accordance with the teachings of the present disclosure.

[0038] Figure 21A 、 Figure 21B 、 Figure 21C and Figure 21D Shown is a cable having a magnetic bracket head and a connector having corresponding magnetic protrusions in accordance with the teachings of the present disclosure.

[0039] Figure 22A and Figure 22B A protective cover configured to interface between a head of a cable and a bracket of a connector in accordance with the teachings of the present disclosure is shown.

[0040] Figure 23A and Figure 23B A connector and cable having an inductive interface according to the teachings of the present disclosure are shown.

[0041] Figure 24 An example thin connector according to the teachings of the present disclosure is shown.

[0042] Figure 25 An example polarized connector according to the teachings of the present disclosure is shown.

[0043] Figure 26A 、 Figure 26B and Figure 26C An example of a protective cover with an integrated cable head according to the teachings of the present disclosure is shown.

[0044] Figure 27A 、 Figure 27B 、 Figure 27C 、 Figure 27D 、 Figure 27E 、 Figure 27F 、 Figure 27G and Figure 27H An example stimulation lead connection system according to the teachings of the present disclosure is shown.

[0045] Figure 28A and Figure 28B An example stimulation lead connection system according to the teachings of the present disclosure is shown.

[0046] Figure 29A 、 Figure 29B 、 Figure 29C 、 Figure 29D 、 Figure 29E 、 Figure 29F 、 Figure 29G 、 Figure 29H 、 Figure 29I 、 Figure 29J 、 Figure 29K and Figure 29L An example push-to-lock connector and connector base of FIG. 28 are shown in accordance with the teachings of the present disclosure.

[0047] Figure 30A 、 Figure 30B and Figure 30C The insert of the push-to-lock connector of FIG. 28 is shown in accordance with the teachings of the present disclosure.

[0048] Figure 31 The body of the push-to-lock connector of FIG. 28 is shown in accordance with the teachings of the present disclosure.

[0049] Figure 32A 、 Figure 32B 、 Figure 32C 、 Figure 32D 、 Figure 32E 、 Figure 32F and Figure 32G is a conceptual diagram of the interaction of the insert's blades with the leads according to the teachings of the present disclosure.

[0050] Figure 33 An example stimulation lead connection system having a clamshell connector in accordance with the teachings of the present disclosure is shown.

[0051] Figure 34A 、 Figure 34B 、 Figure 34C 、 Figure 34D 、 Figure 34E 、 Figure 34F 、 Figure 34G 、 Figure 34H 、 Figure 34I and Figure 34J Shown according to the teachings of this disclosure Figure 33 clamshell connector. DETAILED DESCRIPTION

[0052] As described below, the stimulation lead connection system can include a single deployment device or a group of interconnected devices to combine the implantation of the lead. Compared to previous systems, the lead (also referred to as a microlead, fine wire lead or simple electrode) can generally have a smaller diameter, with the optimal size being less than 1.0 mm, and more preferably less than 0.7 mm. In addition, the electrode can have a generally coiled or spiral structure rather than a smooth cylinder. However, any suitable lead structure can be used. In some examples, the stimulation lead connection system can provide a single device that can locate the desired tissue area, test the stimulation of the tissue area, locate (or reposition) the test signal and / or deploy electrodes or leads. In some such examples, the stimulation lead connection system can enable the repositioning of the device and lead within human or animal tissue without the need to deploy electrodes or leads until the user (e.g., clinician) desires their deployment. This can provide a safe and easy-to-use connection system.

[0053] As used herein, the term "proximal end" in the context of this application generally refers to the end of the electrode that is not inserted into the body, while the term "distal end" generally refers to the end of the electrode that is inserted into the body near a nerve. Depending on the manufacture of the electrode structure, the proximal end may be wrapped in an insulating layer or protective coating or wrapping. To the extent that electrical connection must be made to the proximal end, the assembly in question will allow for the removal of such coating / wrapping. The coating / wrapping may include a marking that serves as a mobility marker, which helps to measure whether the electrode has been repositioned or displaced during use of the system, and particularly when outside of clinician supervision.

[0054] As used herein, the terms inner sheath, introducer, introduction device, introduction needle, inner needle, inner probe, introduction member and / or the like are used interchangeably, unless the context indicates otherwise or warrants a specific distinction between these terms. The terms outer sheath, delivery needle, outer needle, outer probe, outer member and / or the like are used interchangeably, unless the context indicates otherwise or warrants a specific distinction between these terms.

[0055] The introduction device can enable the lead to be placed percutaneously at a safe distance from the surgical site, which can improve safety, minimize risk to the anatomical structures that are the focus of the surgery, minimize the risk of infection, and minimize the potential impact of any infection that occurs. For example, the introduction device can enable the placement of a lead to deliver stimulation to a nerve that innervates an area that may be painful or anticipated to be painful due to the surgical procedure (e.g., the device can enable the placement of a lead to deliver stimulation to the femoral nerve, sciatic nerve, or lumbar plexus that innervates an area, such as a knee that may be undergoing knee replacement surgery), and the device ideally enables the lead to be placed a safe distance away from the surgical site (e.g., the knee) and / or outside the surgical field (e.g., in the upper thigh, thigh, or lower back).

[0056] There is a clinical need for a device that delivers therapeutic electrical stimulation (e.g., peripheral nerve stimulation (PNS)) to nerves innervating a painful area (e.g., peripheral nerves) to provide pain relief. The device can deliver stimulation to nerves that transmit pain signals, or it can deliver stimulation to nerves that do not transmit pain signals, but when the stimulation is delivered, a condition or symptom such as pain can be relieved or improved, and / or function can be improved or restored. The device can deliver peripheral nerve stimulation for pain relief or functional restoration in a variety of settings, including chronic, acute, post-operative, post-traumatic, and intermittent pain and / or loss of function, as well as other conditions (e.g., other types of pain and / or loss of function), and across a range of anatomical regions, including but not limited to extremities (e.g., arms, legs, etc.), extremities (e.g., hands, feet, fingers, toes, etc.), joints (e.g., hips, knees, shoulders, elbows, ankles, wrists, etc.), back, neck, head, face, and other areas.

[0057] The stimulation device can enable the delivery of electrical stimulation to provide pain relief or improved function immediately after surgery. The device can also improve function, strength, and range of motion after surgery, as well as accelerate postoperative recovery. The device can enable the delivery of stimulation before, during, and after surgery, as well as in situations not involving surgery (such as acute or chronic conditions within or outside the surgical setting).

[0058] As described below, a connector and stimulation lead connection system can be used to establish electrical communication between one or more electrodes in a stimulation device and a signal generator. Non-limiting examples of such neurostimulation devices, as well as systems and methods for operating and using such devices and systems, can be found in U.S. Patents 6,845,271; 8,249,713; 8,463,383; 8,626,302; 8,788,046; 8,886,337; 8,954,153; 8,965,516; 9,248,289; 9,827,412; 9,855,427; and 9,895,530, all of which are incorporated herein by reference.

[0059] As non-limiting examples, an example stimulator may be capable of providing at least the following parameters: a range of intensities; a range of amplitudes (e.g., 0.2-20 mA, 0.1-30 mA, 0.1-40 mA, 0.1-50 mA); a range of pulse durations and / or pulse widths (e.g., 10-100 μs, 10-200 μs, 10-100 μs, 10-300 μs, 1-1000 μs, 1-1500 μs, and / or 1-2000 μs; and a range of frequencies (e.g., 1-20 Hz, 5-100 Hz, 1-100 Hz, 1-150 Hz, 1-200 Hz, 1-500 Hz); z, 1-1000Hz, 1-1500Hzm, 1-10,000Hz, 1-100,000Hz). The stimulator can be connected to wireless clinician-programmed software for treatment, software and hardware for wireless patient controllers, and firmware and hardware for miniature body-mounted stimulators. This arrangement allows clinicians and patients to view and adjust treatment parameters without having to directly interface with the stimulator. This prevents patients from having to remove clothing, etc., to access the stimulator during use. In some examples, the stimulator can communicate via physical cables, wires, Bluetooth or other wireless technologies. The present teachings are not limited to any particular configuration.

[0060] The patient controller can also provide a more extensive graphical user interface, including a variety of other options (e.g., profiles specific to the time of day / pain type / expected patient activity type, access to information about pain management, means for communicating with medical professionals, etc.), thereby making it the primary means for starting and changing treatment. Like the stimulator, the controller communicates with the stimulator (or multiple stimulators, if multiple stimulators are included in the system) and an optional programmer unit via physical wires / cables or wirelessly, as described below. The controller can be relatively larger than the stimulator, although a wireless connection will allow the user to carry the controller in clothing and / or generally at a distance and position that is convenient compared to the electrodes and stimulator. The connection between the controller, stimulator, and introducer system can include any connection described herein (e.g., a standard wired connection, a wireless connection—particularly between the controller and stimulator, a wired connection that relies on a quick release mechanism, etc.).

[0061] The stimulator allows the stimulation intensity to be adjusted by controlling the stimulation amplitude and pulse duration, preferably using a single programmable parameter for intensity. The stimulation intensity itself can be determined by multiple parameters, including but not limited to stimulation amplitude and pulse duration. For example, the stimulation intensity can be increased by increasing the stimulation amplitude, pulse duration, or a combination of the two. Using a single parameter to control multiple parameters, such as stimulation amplitude and pulse duration, the complexity of the process of programming stimulation parameters can be reduced by reducing the number of parameters (which can be changed from 2 or more to 1). As a non-limiting example, the minimum value of the stimulation intensity parameter (e.g., 0) can set the stimulation amplitude and pulse duration to their lowest values (e.g., 0.2 mA and 10 microseconds). As another example, increasing the stimulation intensity parameter can change the stimulation amplitude, pulse duration, or both.

[0062] In some examples, the lead connector of the stimulation connection system can enable easy one-handed insertion and coupling of the lead to the system while maintaining mechanical and electrical safety and preventing the patient from intentionally or accidentally disconnecting the lead (or electrode). The lead can be electrically and mechanically coupled to the lead connector. The mechanism by which the lead can be mechanically coupled to the lead connector can be separate from or the same as the mechanism by which the lead is electrically coupled to the lead connector. As described below, the user can couple the lead to the lead connector using one or more of a variety of components such as a knob, button, switch, dial, or lever.

[0063] The lead connector can be detached from the lead and can allow the lead to be reconnected to the lead connector at a different point along the lead (e.g., closer to or farther from the stimulation portion of the lead or electrode). In a non-limiting example, the lead connector can include a lock to prevent the patient from disconnecting the lead. The lock can be opened using, for example, but not limited to, a key, a tool (e.g., a screwdriver, a wrench, or a torque wrench), a password (e.g., a digital combination), or no tool. As another example, the lead connector can minimize or eliminate damage or alteration to the lead structure, allowing the lead to remain sufficiently intact to generally reduce the risk of lead breakage or rupture and allow current to flow throughout the lead. In another example, the lead connector can be attached to the lead before or after insertion into the introducer system, thereby enabling stimulation through the lead tip during the lead placement process. In some examples, the connector can be attached to the lead by dropping the lead into a slot or hole in a block and closing a flap that implements one or more insulation displacement connections (e.g., piercing the insulating material on one side to form a connection with the conductive lead). For example, such a lead connector can improve the speed and convenience of lead connection because it can be attached without the use of tools (e.g., without wire cutters, scissors, and screwdrivers). For example, in this example, the lead can be placed in a slot in the lead connector block and secured using a lockable, reversible one-handed mechanism to displace the insulation on the lead body. One or more insulation displacement mechanisms (sometimes referred to as "blades") within the lead connector can also cut the lead at the distal end of the electrical connection. Once the connection is established and the excess lead is trimmed, a lock (e.g., a slide, twist, button press) can ensure that the flap on the block will not be accidentally reopened. This suppresses the loss of connection between the lead connector and the lead, which will result in the loss of therapeutic benefits. The lead connector can be combined and / or matched with one cable and / or multiple cables (e.g., leads or plugs to a stimulator) to complete the circuit from the stimulator to the lead tip electrode.

[0064] In some examples, the connection between the lead connector and the cable can be magnetic. In this example, the shape of the lead connector and the corresponding head of the cable are configured to prevent the incorrect alignment of the lead connector (for example, the lead connector that only fits together in one direction). Magnetic connection can be used for temporary and permanent stimulation delivery (for example, during the lead placement process or during the patient's use treatment at home). After obtaining the correct lead placement position, the lead connector block can be removed and replaced after removing one or more pins and one or more sheaths of the introducer system. In some examples, the groove containing the lead can be opened by pressing or sliding to deactivate the connection. In this example, the lead connector block can be removed or cut off before removing the introducer, and then quickly reattached to the position of the more proximal end on the lead. After removing the introducer, the lead can be placed in the groove and connected by a one-touch mechanism (for example, pressing, sliding), and then the lead connector can be attached to the stimulator cable.

[0065] In some examples, the magnetic cable connector of stimulator can be used as a quick release connection, which prevents or stops the accidental lead (or electrode) displacement caused by the lead and / or lead being pulled. Due to the disconnection of the magnetic connection between the cable and the lead connector, any force on the lead is interrupted, rather than the force being transferred to the lead to withdraw from the position and the lead. In some examples, the inseparable connection can be achieved by locking the connector and the cable together using a button lock (or any other suitable lock). In addition to cooperating with the lead connector block, in some examples, the magnetic cable connector for stimulator can also cooperate with the lead connector block of the same version, and the lead connector block is connected to the test stimulator via cable. In some examples, the magnetic cable connector derived from stimulator can be bifurcated to be connected with multiple lead connectors (for example, to enable stimulating two leads with a stimulator).

[0066] As described below, the stimulation lead connection system facilitates shorter duration lead placement and stimulation testing procedures. The system also limits the number of percutaneous insertions required, reduces risk to the patient, enables efficient positioning and repositioning of leads for stimulation testing and lead deployment, enables clinicians to correctly and optimally position and deploy leads with minimal or no additional training, and reduces the time required to make electrical connections for testing. As a result, clinicians can deliver therapy to patients (e.g., treating preoperative, intraoperative, and / or postoperative pain) in environments / scenarios that were previously burdensome, impractical, and / or impossible.

[0067] A. Peripheral nerve stimulation

[0068] The following describes an example peripheral nervous system and method that incorporates the features of the present teachings. The system and method can identify an area where localized pain manifestations are present. The pain area can include any appropriate part of the body, such as tissue, skin, bone, joint, or muscle. The system and method can identify one or more spinal nerves that are distant from the area where the pain is manifesting, including the nerve impulses of pain passing through these spinal nerves. The given spinal nerve identified can include a nerve trunk located in a plexus, or branches and / or cords of a nerve trunk, or nerve branches, or a plexus, provided that it is upstream or cranial of the area innervated by the pain. A given spinal nerve can be identified by a medical professional using human anatomy textbooks together with their understanding of the location and nature of the pain or injury, as well as by physical manipulation and / or imaging (e.g., by ultrasound, fluoroscopy, or X-ray examination) of the area where the pain is manifesting. The desired criteria for selection can include identifying a tissue location within a therapeutically effective distance from the nerve or channel that can be accessed by placing one or more stimulating electrodes, assisted by ultrasound or electrolocalization techniques if necessary. The therapeutically effective distance can be defined as meaning that the placement of the lead is in contact with the nerve, or more preferably adjacent to the nerve. The identified nerves may include target peripheral nerves.The identified tissue may include "target tissue."

[0069] One or more electrodes of an electrical stimulation device (e.g., electrical stimulation device 2814) can be percutaneously inserted using one or more percutaneous leads (e.g., one or more leads 206). The systems and methods can place one or more leads with their one or more electrodes in the target tissue in electrical proximity to, but spaced apart from, the target peripheral nerve. The systems and methods can apply electrical stimulation through the one or more stimulation electrodes to electrically activate or recruit the target peripheral nerve, which transmits nerve impulses, including pain, to the spine.

[0070] The systems and methods can apply electrical stimulation to peripheral nerves throughout the body. As non-limiting examples, the peripheral nerves can include one or more spinal nerves in the brachial plexus to treat pain in the shoulder, arm, and hand; and / or one or more spinal nerves in the lumbar plexus to treat pain in the back, thigh, knee, and calf; and / or one or more spinal nerves in the sacral plexus to treat pain in the thigh, calf, and foot; and / or one or more spinal nerves in the cervical plexus to treat shoulder pain.

[0071] For example, if the pinky finger is the location of pain after an injury (e.g., limb replacement surgery), the systems and methods can identify and stimulate the ulnar nerve at an upstream or cranial location that innervates the muscles or skin of the pinky finger, such as in the palm, forearm, and / or upper arm. If the electrical stimulation sufficiently activates the target peripheral nerve at the correct intensity, the patient will feel a pleasant tingling sensation called paresthesia in the same area as their pain, overlapping with the painful area and / or otherwise reducing the pain.

[0072] It should be understood that other words such as buzzing, thumping, etc. can be used to describe the sensation. Inducing paresthesia in the painful area confirms correct lead placement and indicates that the stimulation intensity is sufficient to relieve pain. Percutaneous insertion of the lead can allow the lead to be placed quickly and easily. Placing the lead in a peripheral location (e.g., tissue) where it is less likely to shift can address the problem of lead migration for spinal cord stimulation, which otherwise may result in reduced paresthesia coverage, reduced pain relief, and the need for frequent patient visits for reprogramming.

[0073] Percutaneous placement of the lead in tissue that is electrically close to but spaced apart from the target peripheral nerve can also minimize complications associated with lead placement and migration. In percutaneous systems, an electrode lead, such as a coiled, thin-wire electrode lead, can be used because it is minimally invasive and well-suited for placement near peripheral nerves. The lead can be sized and configured to withstand mechanical forces and resist migration during prolonged use, particularly in flexible areas of the body, such as the shoulder, elbow, and knee.

[0074] Electrode leads can include fine wire electrodes, paddle electrodes, intramuscular electrodes, or universal electrodes that are inserted or surgically implanted near the target peripheral nerve via a needle guide. Once correct placement is confirmed, the needle guide can be withdrawn, leaving the electrode in place. Stimulation can also be applied by penetrating electrodes, such as an electrode array consisting of any number (i.e., one or more) needle electrodes that can be inserted into the target site. In both cases, the lead can be placed using a needle guide, making the placement of the lead / electrode minimally invasive. Example leads can include thin flexible components made of metal and / or polymer materials. By "thin," it is envisioned that the lead may be no greater than 1 mm and / or preferably no greater than about 0.75 mm (0.030 inches) in diameter, but of sufficient diameter to remain intact (e.g., not broken) when the surrounding tissue is compressed and / or bent and / or when removed. However, the present teachings are not limited to such dimensions. Any suitable lead can be used. The leads can have a range of diameters and still be considered small or suitable (e.g., <0.5 mm, <0.6 mm, <0.7 mm, <0.8 mm, <0.9 mm, <1.0 mm, <2 mm and / or <3 mm), and the connectors and other aspects of the present invention are designed to properly accommodate and function using one or more lead sizes and / or size ranges. The lead may also include one or more coiled metal wires within an open or flexible elastomeric core. The wires may be insulated, for example, using a biocompatible polymer film or coating, such as a polyfluorocarbon, polyimide, or parylene as non-limiting examples. The lead may be electrically insulated anywhere except for one (monopole), or two (bipolar), or three (tripolar), for example, at a conductive location near its distal tip. Each conductive location may be connected to one or more conductors or conductive wires, strands, filaments, and / or cables that may extend the length of the lead and lead extension or a portion thereof. The conductors may provide electrical continuity from the conductive location through the lead to an external pulse generator or stimulator.

[0075] The conductive locations or electrodes may include deinsulated regions of other insulated conductors or conductive wires, strands, filaments, and / or cables that may extend the entire length of the insulated electrode or a portion thereof. The deinsulated conductive region of the conductor may be formed differently, for example, it may be wound at a different pitch, or wound at a larger or smaller diameter, or molded to different sizes. The conductive locations or electrodes may include a separate material (e.g., a metal or a conductive polymer) that is exposed to the body tissue to which the conductor of the wire is joined.

[0076] Leads can be provided in sterile packaging and can be preloaded in or on an introducer needle or other needle used during lead placement. Alternatively, the lead can be introduced via the same needle that is used to inject an anesthetic or analgesic during peripheral nerve block, which is typically used after limb joint replacement surgery, or can be provided separately as one or more independent components. Packaging can take various forms, and the arrangement and contents of the packaging can be relevant to its use as appropriate, including but not limited to lead, introducer system, related cables, external pulse generator and / or related bandage and / or covering. Packaging can include a sterile wrapping assembly. Packaging can include an inner tray made of any appropriate material, for example, made of die-cut cardboard, plastic sheet or thermoformed plastic material, which can accommodate contents. As will be described in more detail below, packaging can also desirably include instructions for use about using the contents of the packaging to perform lead positioning and placement procedures.

[0077] The lead may have mechanical properties in terms of flexibility and fatigue life, taking into account the dynamics of the surrounding tissue (i.e., stretching, bending, pushing, pulling, crushing, etc.), thereby providing a working life without mechanical and / or electrical failure. The material of the electrode may prevent the ingrowth of connective tissue along its length or its applicable portion, thereby not preventing its withdrawal at the end of its use. However, it may be necessary to promote the ingrowth of connective tissue at the distal end of the electrode to enhance its anchoring in the tissue.

[0078] Examples of leads can include minimally invasive coiled wire leads and electrodes. The electrodes can also include an anchoring element at their distal tip. In some examples, the anchoring element can take the form of a single and / or multiple barbs or bends.

[0079] The anchoring element can be sized and configured so that when in contact with tissue, it grips the tissue to resist the electrode from moving or migrating out of its correct position in the surrounding tissue. The anchoring element can be prevented from fully engaging body tissue until after the electrode is correctly positioned and deployed.

[0080] In some examples, the electrode lead may also include one or more anchoring elements at or near its distal tip or region. The anchoring element may take the form of a shovel-like paddle or fan-shaped leaf array at the proximal end of the proximal-most electrode (although one or more paddles may also be at the proximal end of the distal-most electrode, or at the distal end of the distal-most electrode). As shown, the paddles may be sized and configured so that they do not cut or scratch surrounding tissue. The anchoring element is sized and configured so that when in contact with tissue, it purchases in the tissue to resist the electrode from moving out of or migrating out of its correct position in the surrounding tissue (e.g., muscle). The anchoring element may be prevented from fully engaging body tissue until after the electrode is deployed. As previously described, the electrode cannot be deployed until it is correctly positioned during the implantation (lead placement) process. In addition, the lead may include one or more ink markings to assist the clinician in correct placement. Alternatively or in addition, the anchoring element may be any lead anchor described below, such as a folding lead anchor, a snap-on lead anchor, an adhesive-based lead anchor, and / or a dual-purpose lead anchor.

[0081] Alternatively or in combination, the electrode may be delivered via any type of nerve cuff (spiral, helical, cylindrical, book-shaped, flat interface nerve electrode (FINE), slow closing FINE, etc.), paddle (or paddle-style) electrode lead, cylindrical electrode lead, echogenic needle (i.e., visible under ultrasound), and / or other leads placed surgically or percutaneously into the tissue at the target site.

[0082] The leads can be exited through the skin and connected to one or more external stimulators. In addition, the leads can be connected to internal and external coils as needed for RF (radio frequency) wireless telemetry communication or inductively coupled telemetry to control the implanted pulse generator. The implanted pulse generator can be located at a distance from the electrodes (remote), or the implanted pulse generator can be integrated with one or more electrodes (not shown), thereby eliminating the need to run the leads subcutaneously to the implanted pulse generator.

[0083] The introducer can be insulated along the length of the shaft, except for those areas corresponding to the exposed conductive surfaces of the electrodes housed within the introducer. These surfaces on the outside of the introducer can be electrically isolated from each other and from the shaft of the introducer. These surfaces can be electrically connected to connectors at the end of the introducer body. This can allow connection to an external stimulator during the implantation process. Applying a stimulation current through the outer surface of the introducer can provide an approximation of the response that the electrode will provide when it is deployed in the current position of the introducer.

[0084] The introducer can be sized and configured to be manually bent before insertion through the skin. This can allow the physician to place the lead in a location that is not in a clear line with the insertion site. The structure and material of the introducer can allow bending without interfering with lead deployment and introducer withdrawal, thereby leaving the lead in the tissue.

[0085] Described herein are systems, devices, and methods for conveniently providing and / or facilitating single deployment devices to merge lead implants. Compared to previous systems, leads (also referred to as microleads, fine-wire leads, or simple electrodes) can typically have a smaller diameter, with an optimal size being less than 1.0 mm, and more preferably less than 0.7 mm. In addition, the electrodes can have a generally coiled or spiral structure, rather than a smooth cylinder. However, the present teachings are not limited to such lead structures. Without departing from the present teachings, any appropriate configuration can be used. The examples described herein can conveniently provide a single device that can locate a desired tissue region, test tissue region stimulation, locate (or relocate) a test signal, and / or deploy electrodes or leads. The examples described herein can enable repositioning of devices and / or wires within human or animal tissue while avoiding deployment of electrodes or leads until the user (e.g., clinician) desires their deployment. The examples described herein can provide easy-to-use and safe systems, devices, and / or methods.

[0086] The introduction device enables the lead to be placed percutaneously at a safe distance from the surgical site, which can improve safety, minimize risk to anatomical structures that are the focus of the surgery, minimize the risk of infection, and / or minimize the potential impact of any infection that does occur. As a non-limiting example, the device can enable placement of leads to deliver stimulation to nerves that innervate an area that may be painful or anticipated to be painful due to surgery (e.g., the device can enable placement of leads to deliver stimulation to the femoral nerve, sciatic nerve, and / or lumbar plexus that innervate an area, such as a knee that may be undergoing knee replacement surgery), and / or the device desirably enables the lead to be placed a safe distance away from the surgical site (e.g., the knee) and / or outside the surgical field (e.g., in the upper thigh, thigh, and / or lower back).

[0087] As part of a non-surgical procedure, the introduction device may enable target nerves to be identified prior to lead placement and / or prior to lead deployment.

[0088] There is a clinical need for a device that delivers therapeutic electrical stimulation (e.g., peripheral nerve stimulation (PNS)) to nerves innervating a painful area (e.g., peripheral nerves) to provide pain relief. The device can deliver stimulation to nerves that transmit pain signals, and / or it can deliver stimulation to nerves that do not transmit pain signals, but when the stimulation is delivered, a condition or symptom such as pain can be relieved or improved, and / or function can be improved or restored. The device can deliver peripheral nerve stimulation for pain relief or functional restoration in a variety of settings, including chronic, acute, post-surgical, post-traumatic, and intermittent pain and / or loss of function, as well as other conditions (e.g., other types of pain and / or loss of function), and across a range of anatomical regions, including but not limited to extremities (e.g., arms, legs, etc.), extremities (e.g., hands, feet, fingers, toes, etc.), joints (e.g., hips, knees, shoulders, elbows, ankles, wrists, etc.), back, neck, head, face, and / or other areas.

[0089] The device can enable the delivery of electrical stimulation to provide pain relief or improved function immediately after surgery. The device can also improve function, strength and / or range of motion after surgery, and accelerate postoperative recovery. The device can enable the delivery of stimulation before, during and / or after surgery and in situations not involving surgery (such as acute and / or chronic conditions within or outside the surgical setting).

[0090] Additional examples of transcutaneous stimulation systems according to the present teachings are described below. In the description, all details and components may not be fully described or shown. Instead, the main features or components are described, and in some cases, differences from the above examples may be noted. In addition, it should be understood that these additional examples may include elements or components that are not shown or described. Therefore, the description of these additional examples is not all-inclusive or exclusive. In addition, it should be understood that the features, components, elements and functions of the various examples can be combined or modified to achieve the desired transcutaneous stimulation system without departing from the spirit and scope of the invention.

[0091] The systems and methods described below can reduce lead placement and / or testing procedure duration when placing one or more self-anchoring leads. Specifically, by reducing the challenges of making electrical and mechanical connections to percutaneous leads and / or other system components, placement, connection, disconnection, reconnection, and / or testing times are reduced compared to prior art systems.

[0092] As described below, systems and methods are convenient for testing using leads, wherein a non-limiting example is a connector that can quickly and effectively electrically connect the proximal end of the lead to an external stimulator via a wire in a useful manner (e.g., a firm / stable mechanical and / or electrical connection), and can reduce the duration of the process. Being able to easily remove the connector can also reduce process time, because when the lead is deployed in the prior art, the introducer system must be withdrawn on the lead, and the connector prevents this from happening and will need to be removed because the introducer needle / sheath cannot be withdrawn therefrom without first disconnecting the lead. Although simple connectors (e.g., commercial alligator clips) can be used, such connectors may be difficult to use in surgical environments with spiral leads of very small diameter. Clinicians and / or staff may have difficulty connecting the tiny end of the wire to a typical / mechanical electrical connector. A non-limiting example that addresses these problems is a custom connector that consists of a channel into which the end of the lead can be easily inserted. The channel secures and / or guides the lead to a connector area where the user can manipulate, via a lever or button, teeth, rings, and / or surfaces that may be spring-loaded to clamp onto the lead and establish an electrical connection with the lead. The connector may have attached wires and a plug that enables connection to an external stimulator.

[0093] In some examples, the lead connector can enable easy one-handed insertion and coupling of the lead to the system while maintaining mechanical and electrical safety, and / or preventing the patient from intentionally or accidentally disconnecting the lead (or electrode).

[0094] The leads can be electrically and / or mechanically coupled to the lead connector. The mechanism by which the leads can be mechanically coupled to the lead connector can be separate from or the same as the mechanism by which the leads are electrically coupled to the lead connector. A user can couple the leads to the lead connector using components including, but not limited to, knobs, buttons, switches, or dials.

[0095] The lead connector can be detachable from the lead and can enable the lead to be reconnected to the lead connector at a different point along the lead (e.g., closer to or further away from the stimulation portion of the lead and / or electrode). In a non-limiting example, the lead connector can include a lock to prevent the patient from disconnecting the lead. The lock can be opened using, for example, but not limited to, a key, a tool (e.g., a screwdriver, a wrench and / or a torque wrench), a password (e.g., a digital combination), or no tool. In another non-limiting example, the lead connector can minimize or eliminate damage and / or changes to the lead structure, enabling the lead to remain sufficiently intact to generally reduce the risk of lead breakage and / or rupture and enable current to flow through the entire lead. In another non-limiting example, the lead connector can be attached to the lead before and / or after insertion of the introducer system, thereby enabling stimulation by the lead tip during the lead placement process. In some examples, the connector can be attached to the lead by dropping the lead into a slot or hole in the block and closing a flap that implements an insulation displacement connection (e.g., cutting away an insulating material to form a connection with the conductive lead). Such a lead connector can increase the speed and / or convenience of lead connection because it can be attached without the use of tools (e.g., without wire cutters, scissors, and / or screwdrivers). For example, in such an example, the lead can be placed in a slot in the lead connector block and secured using a lockable, reversible, one-handed mechanism to displace the insulation on the lead body. One or more insulation displacement mechanisms within the lead connector can also cut the lead at the distal end of the electrical connection. Once the connection is established and the excess lead is trimmed, a lock (e.g., a slide, twist, button press) can ensure that the flap on the block cannot be accidentally reopened. This feature prevents loss of connection between the lead connector and the lead, which would result in loss of therapeutic benefit. The lead connector can mate with another lead connector (e.g., a lead or plug to a stimulator) to complete the circuit from the stimulator to the lead tip electrode.

[0096] In some examples, the connection between the two lead connectors can be magnetic. In this example, the shape of the lead connector can prevent the incorrect alignment of the lead connector (for example, the lead connector that only fits together in one direction). Magnetic connection can be used for temporary and / or permanent stimulation delivery (for example, during the lead placement process and / or during the patient's use treatment at home). After obtaining the correct lead placement position, the lead connector block can be removed and replaced after removing one or more pins and one or more sheaths of the introducer system. In some examples, the groove containing the lead can be opened by pressing and / or sliding to deactivate the connection. In this example, the lead connector block can be removed or cut off before removing the introducer, and then quickly reattached to the position of the more proximal end on the lead. After removing the introducer, the lead can be placed in the groove and connected by a one-touch mechanism (for example, pressing, sliding), and then the lead connector can be attached to the stimulator cable.

[0097] The magnetic connection can be used as a quick release connection, which will prevent the accidental lead (and / or electrode) displacement caused by the pulled lead and / or cable. Due to the disconnection of the magnetic connection between the lead and the lead connector block, any force on the lead will be released, rather than transferring the force to the lead withdrawal position and the lead. If the clinician needs, a permanent connection can be achieved by locking the two connector parts together using a button lock (and / or any other suitable lock). In addition to mating with the lead connector block, in some examples, the magnetic cable connector for the stimulator can also be mated with the lead connector block of the same version, which is connected to the test stimulator via a cable. In some examples, the magnetic cable connector derived from the stimulator can be forked to connect with multiple lead connector blocks (for example, to enable two leads to be stimulated with one stimulator).

[0098] An exemplary stimulator may be capable of providing at least the following parameters: an amplitude of 0.1-30 mA; a pulse duration of 10-200 μs; and a frequency of 1-150 Hz. As non-limiting examples, an exemplary stimulator may be capable of providing parameter ranges such as: an intensity range; an amplitude range (e.g., 0.2-20 mA, 0.1-30 mA, 0.1-40 mA, 0.1-50 mA); a range of pulse durations and / or pulse widths (e.g., 10-100 μs, 10-200 μs, 10-100 μs, 10-300 μs, 1-1000 μs, 1-1500 μs, and / or 1-2000 μs); and a frequency range (e.g., 1-20 Hz, 5-100 Hz, 1-100 Hz, 1-150 Hz, 1-200 Hz, 1-500 Hz, 1- 1-1000Hz, 1-1500Hzm, 1-10,000Hz, 1-100,000Hz). The stimulator can be connected to wireless clinician-programmed software for treatment, software and hardware for wireless patient controllers, and firmware and hardware for miniature body-mounted stimulators. This arrangement enables clinicians and / or patients to view and / or adjust treatment parameters while avoiding the need to directly interface with the stimulator. This can prevent patients from having to remove clothing, etc., to contact the stimulator during use. In some examples, the stimulator can communicate via physical cables, wires, Bluetooth, and / or other wireless technologies. The present teachings are not limited to any particular configuration.

[0099] The patient controller can also provide a more extensive graphical user interface, including a variety of other options (e.g., profiles specific to the time of day / pain type / expected patient activity type, access to information about pain management, means for communicating with medical professionals, etc.), thereby making it the primary means for starting and / or changing treatment. Like the stimulator, the controller communicates with the stimulator (or multiple stimulators, if multiple stimulators are included in the system) and an optional programmer unit via physical wires / cables or wirelessly, as described below. The controller can be relatively larger than the stimulator, although a wireless connection will enable the user to carry the controller in clothes and / or generally at a distance and position that is convenient compared to the electrodes and stimulator. The connection between the controller, stimulator, and introducer system can include any connection as described herein (e.g., standard wired connection, wireless connection-particularly between the controller and stimulator, a wired connection that relies on a quick release mechanism, etc.).

[0100] The stimulator enables adjustment of the stimulation intensity by controlling the stimulation amplitude and / or pulse duration, preferably using a single programmable parameter of intensity. The stimulation intensity itself can be determined by multiple parameters, including but not limited to stimulation amplitude and / or pulse duration. For example, the stimulation intensity can be increased by increasing the stimulation amplitude, pulse duration, or a combination of the two. Using a single parameter to control multiple parameters, such as stimulation amplitude and / or pulse duration, the complexity of the process of programming stimulation parameters can be reduced by reducing the number of parameters (which can be changed from 2 or more to 1). As a non-limiting example, the minimum value of the stimulation intensity parameter (e.g., 0) can set the stimulation amplitude and pulse duration to their lowest 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.

[0101] In some examples, increasing the stimulation intensity parameter from a minimum value can first increase the stimulation amplitude while keeping the pulse duration at a minimum value until the maximum value of the stimulation amplitude (e.g., 20mA-30mA) is reached. Then, continuing to increase the stimulation intensity parameter can keep the stimulation amplitude fixed at a maximum value while increasing the pulse duration until the maximum value of the pulse duration is reached. In this example, the stimulation intensity is easy to program and can be increased while keeping the pulse duration as short as possible, thereby keeping the stimulation charge required to activate the nerve fibers as low as possible and improving the ability of the patient / clinician to selectively stimulate large diameter fibers rather than small diameter fibers. In another non-limiting example, increasing the stimulation intensity parameter from a minimum value can first increase the stimulation amplitude while keeping the stimulation amplitude at a minimum value. Then, continuing to increase the stimulation intensity parameter beyond the maximum value of the pulse duration (e.g., 200 microseconds), the pulse duration can be kept fixed at a maximum value while increasing the amplitude until the maximum value of the stimulation amplitude is reached. In this example, the stimulation intensity is increased while keeping the stimulation amplitude as low as possible, which makes the power consumption of the pulse as low as possible for a given charge per pulse.

[0102] The introducer system described herein may also reduce the risk of post-lead placement problems by reducing the risk of lead fracture. This risk reduction stems from the shape of the electrode itself—in terms of its self-anchoring, migration- and infection-resistant small-diameter helix / coil and / or its distal anchoring system—and from the reduced level of stress placed on the lead during insertion and test stimulation procedures by being able to retract and protect the electrode during insertion and / or repositioning.

[0103] Other advantages include the ability to minimize the duration of lead placement and stimulation testing procedures. The system also limits the number of percutaneous insertions required, reduces risk to the patient, enables efficient positioning and repositioning of leads for stimulation testing and / or lead deployment, enables clinicians to correctly and optimally position and deploy leads with minimal or no additional training, and reduces the time required to make electrical connections for testing. As a result, clinicians can deliver treatments to patients (e.g., treating preoperative, intraoperative, and / or postoperative pain) in environments / scenarios that were previously burdensome, impractical, and / or impossible. The introducer also overcomes limitations of previous systems by minimizing or eliminating the need for: a) insertion of multiple percutaneous devices; b) repositioning of leads; and / or c) the extended time required for test stimulation and / or lead placement procedures.

[0104] Examples may include increasing the strength of a coiled / helical lead by, for example, incorporating one or more conductors or conductive wires, strands, filaments, and / or cables of a high tensile strength material (such as, but not limited to, MP35N, nickel-chromium-molybdenum superalloy) into the lead. Adding such strands and / or replacing current lead strands with such strands and / or wires increases the lead's resistance to breakage, increasing the utility of a self-anchoring, migration- and / or infection-resistant small diameter coil / helical lead for use in an electrical stimulation system.

[0105] An example can include increasing the strength of a lead by adding new strands and / or filaments within the open core / center of a helically coiled lead. In this non-limiting example, the new strands and / or filaments will not completely fill the opening. A gap will remain between the outside of the new strands and / or filaments and the inside of the coiled wire. In addition, such new strands and / or filaments will not extend the entire length of the coiled lead. In this non-limiting example, these two arrangements help the lead remain flexible under axial and radial forces during normal use. When the lead is withdrawn, as the coiled wire straightens, the inner diameter of the lead's coil will decrease and / or the coiled wire will be constrained to the center strands / filaments. As a result, the lead has higher tensile strength and lower flexibility during the removal process compared to the normal use configuration. The new strands / filaments in the core can be metal (e.g., 316L or MP35N), or it can be a polymer (e.g., aramid). Such an example may be advantageously combined with other aspects disclosed herein (eg, using a stylet proximate to or even as part of the strands and / or filaments).

[0106] The present system for percutaneous placement of small diameter coiled leads also reduces the risk of accidental lead displacement. The purpose of avoiding lead displacement can be achieved by self-anchoring, migration-resistant and / or infection-resistant small diameter coil / spiral leads. In addition, these advantages are particularly useful (compared to previous systems) during the initial period of time that the lead remains in the desired tissue (e.g., in the period before the lead is completely encapsulated in the connecting tissue, or from 1 day to several months of indwelling). Other advantages (perhaps in addition to the other advantages mentioned herein) include the ability to minimize the duration of the lead placement and / or stimulation testing process; reducing the number of percutaneous insertions required; reducing the risk to the patient by enabling effective positioning and repositioning of the lead for stimulation testing and / or correct / optimal deployment of the lead by the clinician with minimal or no additional training, and by reducing the time required to form an electrical connection for testing. Clinicians can deliver treatment to patients (e.g., treating preoperative, intraoperative and / or postoperative pain) in environments / scenarios that were previously burdensome, impractical and / or impossible.

[0107] Once the lead is placed in the patient, the introduction device can be disengaged and removed. The proximal portion of the lead can then engage with the lead connector unit. The lead connector can have an insulation displacement connector (IDC) and a groove and / or channel configured to receive the lead. The groove and / or channel can include a contact strip with a receiving member (e.g., a microstructured barb, a snap, a magnet, etc.) to hold the lead in place.

[0108] An example lead connector can eliminate the need for a separate tool because it can enable a one-handed push mechanism for the clinician and / or patient. The lead connector unit can also include a disconnect connection, for example, the lead connector end includes a magnet, where the opposite end of the lead connector cable end has a metallic and / or oppositely charged magnet, enabling the clinician, patient, etc. to easily disconnect the cable from the unit. This magnetization or other type of connection can be integrated anywhere along the body of the unit. Other types of removable connections are also contemplated for the connection mechanism, including snaps, adhesives, clips, mandatory fittings and / or any other suitable means of connection.

[0109] Additionally or alternatively, the connector can have a rotating element, such as a knob, dial, spool, and / or post. The rotating element can mechanically and / or electrically engage the lead to help adjust the tension of the detachable connection having tension formed by the electrode, lead connector, and lead. The rotating element can include a predetermined tension release and / or recoil mechanism that responds to a disconnection force by releasing excess lead wrapped around the element. In like manner, the lead connector can achieve such tension release via a slider or other motion that does not require rotation in nature. As with the detachable aspect of the lead connection, tension release can occur at a force that is less than or equal to half the force required to displace the electrode from its initial position and / or move the electrode out of the way.

[0110] The IDC mechanism can help connect the lead into the groove to enable the connection between the receiving member and the lead. In this example, the clinician relies on his or her dominant or non-dominant hand to insert and connect the lead. The IDC mechanism can also strip any insulation from the lead to establish better electrical contact between the lead and the unit, groove and / or channel. The IDC can be integrally formed with the lead connector unit or separately attached to the lead connector unit.

[0111] Additionally or alternatively, the IDC may include a drawer and / or tray, a slot and / or sliding mechanism type mechanism and / or a pivoting tray that rotates relative to a pivot and can be inserted into and removed from the IDC body. The slot may bisect a portion of the tray. The slot may have an appropriate shape and size to securely engage the leads within the tray and / or may include a slidable portion, jaws, barbs and / or the like. The tray may be rotated so that the proximal end of the lead is completely within the IDC while the other portion extends out of the unit. Springs, locks and / or guide mechanisms may also be provided to better control the drawer and / or tray, slot and / or sliding mechanism, channel and / or tray during operation.

[0112] Some examples may have a generally cylindrical shape. The IDC may include holes, slots, and / or openings into which the leads may be inserted. The IDC may include an actuating lever AL to twist and / or rotate the IDC body relative to the portion containing the slots so that the leads are secured within the IDC 1089. If desired, barbs may be included within the IDC if it is necessary to remove insulation from the leads to expose the underlying wires. Mating guides and / or grooves (not shown) may facilitate relative movement of the bodies, and stops and locking mechanisms may also be included to prevent accidental movement.

[0113] The lead connector can be bifurcated to receive multiple leads. For example, multiple slots and / or funnels can connect multiple leads to a single stimulator to enable therapeutic stimulation to be provided to various parts of the body.

[0114] The connection between the lead connector and the electrode can be detachable. Detachability can include but is not limited to a magnet, such as an insert-molded neodymium magnet, which can be formed on one or both ends of the connector and the lead (if at both ends, the stimulator will also have a detachable connection as described herein). Depending on the manufacturing process, the magnet and how the magnet is installed together, it is possible to distinguish connection points. For example, the lead connector can have a stepped connection port that matches the corresponding stepped connection on one of the lead. Alternatively, a circular magnet can be located at the top of the connector lead. Slight indentation and / or groove and / or other releasable force can be provided to enable the experience of "snap-in" feeling, which can provide the user with tactile and / or auditory and / or other feedback about connection status.

[0115] In addition to or in place of magnets, a spring loaded fitting may be used.While particular use is contemplated at the connection between a lead connector and an electrode, the fitting is described generally so that it may be used with any component.

[0116] In some examples, the lead connector and / or the leads can include detachable connections that are configured so that if an unwanted force is applied to them or their connections, neither the stimulator nor the leads will be displaced. For example, the connection between the leads and the stimulator can be detachable upon application of a predetermined force. Once placed in the appropriate position within the patient's body, the predetermined force can be calculated to generally prevent the electrodes from moving.

[0117] Alternatively or in addition, the lead itself can be detachable (e.g., in the middle, so that it is actually multiple leads, e.g., two or more). The lead can be detached at any point between the lead and the stimulator, e.g., the lead can be disconnected at either end. Further, a predetermined detachable portion can be between the lead and the stimulator, along any portion of the lead length. For example, two or more leads can be selectively attached at a separation point to disconnect when a predetermined force is applied. In addition, although the present disclosure indicates that these parts are detachable, they can also be reattached. This can enable the system to be used as a failsafe mechanism to prevent damage and / or injury to the system, components, and / or patients.

[0118] In addition to simply being safe to detach, circuitry in the lead (and / or other components, such as a lead connector) can prevent the delivery of unwanted stimulation if disconnected during stimulation. As a non-limiting example, the lead can be a "smart lead" that, in addition to the conductive pathway, has components that minimize the risk of exposing the patient to unwanted stimulation (e.g., minimize and / or eliminate the possibility of the patient receiving an electric shock) if the lead is accidentally disconnected during use.

[0119] All of the aforementioned connections rely on mating components. To prevent improper installation, each pair can be given a unique shape. Sensors or other circuitry can be used at the connection points to further enhance the user alert features described herein. Such sensors and / or circuitry can be inherent to the electrical signal delivering the stimulus, and / or a separate signal can be established.

[0120] In some examples, the connection may consist of a lead connector terminal plug having at least two or three prongs of a steel conductive blade that is attracted to a magnetic armature at the lead connector end.

[0121] The lead can optionally be coupled to the stimulator. The stimulator can include a battery, a programmable memory unit, and the circuitry necessary for the therapeutic stimulation inherent to the delivery system. In some examples, the battery can be embedded in the lead connector and / or another electrode. The battery can be thin, flexible, and powerful. The battery can contain at least 24 hours of power before needing to be recharged and / or replaced to maximize usage. The stimulator can also include a graphical user interface to communicate with the patient and / or clinician. It can include LEDs and / or other visual markers to communicate actions, errors, and / or other relevant information about the operation of the stimulation system. The stimulator can enable the patient and / or clinician to adjust the operation of the system. In addition, the stimulator can be worn on the patient's body, thereby minimizing cables and / or making the system easier to wear than traditional external stimulators. The stimulator can also be waterproof for easy all-day wear.

[0122] In addition, the introduction device can be paired with a customized bandage system that minimizes the risk of lead displacement during use. The lead and lead connector unit can be protected and / or attached to the patient with a customized bandage. The bandage can eliminate the need for separate tape to secure the lead and / or lead connector. The bandage can be integrated with the wire connector unit so that the clinician and / or patient can easily and consistently remove and / or replace the bandage while avoiding inadvertently pulling on the lead and / or otherwise displacing it. The bandage can be made of the same film material used in standard bandages, such as a porous or non-porous film, including but not limited to any polymer material, including but not limited to polyethylene, metallocene-catalyzed polyethylene, polypropylene, polyolefin copolymers, and / or ethylene vinyl acetate copolymers or other suitable materials. The bandage can also include an adhesive material. Suitable adhesives can include but are not limited to acrylic, dextrin, and / or polyurethane-based adhesives and natural and / or synthetic elastomers. The adhesive can also include amorphous polyolefins, which include amorphous polypropylene. In some examples, the bandage can have an adhesive periphery, including an optional removal sheet. The adhesive periphery can prevent the lead from being exposed to any adhesive surface and / or being inadvertently attached to the bandage. The center of the bandage can include an absorbent pad, which is configured to cover the entry point of the lead into the patient. The absorbent pad can be configured to absorb any fluid leaving the lead insertion site, for example, any type of liquid (including but not limited to blood, pus) that may ooze out from the lead insertion site. The size of the pad can enable the patient and / or clinician to view the area around the lead exit site, to judge any infection and / or abnormal existence. The absorbent pad can be surrounded by the transparent polyethylene portion of the bandage, which enables the clinician and / or patient to better see the placement of the bandage. The pad itself may be transparent and without adhesive, so that the clinician and / or patient can better see the placement of the bandage, view the area around the lead exit site, to judge any infection and / or abnormal existence, while avoiding adhesion to the lead and / or connector, to avoid the accidental removal, breakage and / or migration of the lead during bandage placement and / or replacement. The cutouts around the bandage's adhesive perimeter overlie the lead connector, eliminating gaps in the bandage seal but enabling direct contact between the clinician and / or patient with the lead connector during the removal / attachment process. During removal, the patient and / or clinician can place their fingers on the pad and lead connector unit to generally prevent the lead from pulling on the patient's skin. This can be particularly useful in hard-to-reach locations on the patient's body and / or on parts of the body that move frequently (e.g., arms, legs, back, head, etc.).

[0123] When applying and / or changing the bandage, the clinician and / or patient can disconnect the lead connector cable from the stimulator (not shown) and apply a temporary tape strip to apply pressure to the lead connector. The clinician and / or patient can apply additional pressure to the lead connector when removing the bandage from the patient. The site can then be inspected and / or cleaned. A new bandage can be applied to the site, the temporary tape strip can be removed, and the lead connector can be reconnected to the stimulator.

[0124] The present teachings are not limited to any particular treatment or indication. The system can be applied to any type of treatment, including but not limited to postoperative pain patients or any type of pain patients, especially chronic pain patients (e.g., neuropathic pain, headache and / or back pain patients).

[0125] A lead connector (e.g., any connector described below) can include a lead storage mechanism to store excess lead (e.g., when the lead is coupled to the lead connector). Such a mechanism can reduce the excess length of the lead between the lead connector and the point where the lead leaves the body. This can reduce the risk of being stuck on an object and / or being pulled and / or broken. For example, if the lead is stuck on an external object or from a body part, the excess lead stored on the mechanism may be released instead of displacing or moving the lead from the tissue, thereby breaking the lead (inside or outside the body) and / or pulling the lead out and / or disconnecting from the lead connector. In a non-limiting example, the mechanism can be a spool on which the lead is manually and / or automatically (e.g., using a spring). In another non-limiting example, the mechanism can be located outside the lead connector or inside the lead connector. In addition, the lead connector can be padded on one or more sides to provide comfort when wearing the lead connector.

[0126] As described below, the lead connector can also be designed to be easily coupled to the stimulator, and / or can be connected using one hand, such as by magnetic connection. However, it should be understood that, although magnetic connection is described, the connection can be any mechanical connection in addition to or in place of magnetic connection. The connection can be oriented at various angles relative to the skin surface. In a non-limiting example, the connection is typically oriented perpendicular to the skin. In another non-limiting example, the connection is typically parallel to the skin surface. In another example, the connection may be easy for the user to perform (e.g., not requiring great flexibility, even when connected without looking at the connector) and / or sufficiently sturdy to prevent unintentional disconnection (e.g., due to common body movements and / or less force, etc.), while being disconnected when subjected to a stronger force that may displace the lead (e.g., pulling or dragging the lead connector and / or the stimulator attached to the lead connector from an external object and / or body part). The connection can prevent the lead from being displaced and / or broken by disconnecting the lead connector and / or the lead when pulling the lead instead of transmitting force along the lead. In a non-limiting example, the magnetic connector can be configured such that ambient magnetic fields are reduced and / or avoid interference with objects (eg, credit cards, cell phones) placed near the magnetic connector.

[0127] Furthermore, the leads can be connected directly to the stimulator (i.e., the lead connector can be built into or integrated with the stimulator). The stimulator can be placed directly above or near the lead exit site to protect the exit site. There may be a clear window through which the safety of the lead exit site can be monitored (e.g., infection, irritation).

[0128] In another non-limiting example, the lead can be connected to the lead connector using a jack and a plug, and the jack can be located on the lead and / or oriented at an angle (such as 90 degrees) to the lead. The jack can be connected to the plug on the lead connector using a downward force, enabling a one-handed connection. The distance between the magnetic armature of the plug and the permanent magnetic structure of the lead connector is very small, meaning that the residual magnetic field outside the lead connector can be very small.

[0129] The cable can be attached to the stimulator and / or stored and / or organized (e.g., wrapped, coiled, reeled) to reduce the length of the lead (or leads) that may, for example, be stuck on an external object or body part. In a non-limiting example, redundant cable can be stored in a storage device attached to the cable, on a lead connector and / or on the stimulator. In a non-limiting example, the storage device is a spool, and the cable can be wound around this spool manually or automatically (e.g., via a spring). In some examples, the cable can be coiled and / or wound around the spool on the stimulator, and the force on the lead causes the cable to be unfolded from the spool rather than disconnected from the stimulator, and the force is transmitted to the lead connector and / or the cable. In some examples, the cable and / or any connector can have a detachable aspect so that tension is released under a predetermined force, and this predetermined force is less than the force required for the lead displacement, the electrode is moved from its initial position, the lead fracture and / or the shape and / or structure of the lead to be permanently deformed.

[0130] The stimulation system can include leads that attach to the available stimulators in a variety of lengths. In a non-limiting example, the lead having the shortest length that enables connection between the stimulator and the lead connector can be selected to reduce the risk of the lead snagging on an object or body part and / or disconnecting the system, dislodging the lead, and / or causing the lead to break.

[0131] In some examples, the stimulator can enable coordinated stimulation across two or more stimulators. Alternatively or in addition, the controller and / or programmer unit can enable coordinated stimulation across two or more stimulators. Coordinated stimulation can enable the stimulation across multiple stimulators to start and stop in a coordinated manner to avoid asynchronous activation of muscles on both sides of the body (e.g., back and / or trunk), which may cause loss of balance or discomfort. Controlling the stimulation across multiple stimulators may also prevent synchronous stimulation, for example, to avoid activating relative muscles (e.g., biceps and triceps), which may cause discomfort. In a non-limiting example, one of the stimulator, controller and / or programmer unit can directly communicate with other stimulators. In another non-limiting example, each stimulator can be connected to a central control unit, which may be another stimulator or may be a non-stimulation control unit. In a non-limiting example, the communication between the stimulator and / or control unit (controller or programmer unit) can be wireless (e.g., via Bluetooth, Wi-Fi) or wired (e.g., cable).

[0132] In some examples, the stimulator is worn on the body via a gel patch electrode used as a return electrode, and is connected to a compartment (e.g., a circular shape and a minimum profile height) that is electrically connected to two snap-fit connections. In some examples, the stimulator has a minimal user interface (e.g., a button start / stop, LED lights, and / or loudspeakers and / or buzzers) to provide key feedback to the patient. For example, if the battery is low and / or there is a problem about stimulation, the light may flicker or light up (e.g., different colors and / or different flash patterns). This important feedback will remind the patient and / or clinician to solve any problem, such as battery failure, adhesive pads coming off and / or disconnecting. In the non-limiting example with a magnetic lead connector, it is important that the stimulator generates an alarm if the quick-release cable is accidentally displaced without the patient's knowledge. In addition, stimulation cessation due to, for example, high electrode impedance problems (e.g., due to loss of connection between the skin and / or return electrodes), and / or lead errors that may affect the duration of treatment use and / or the treatment benefits received by the patient, as well as auditory and / or visual alarms of the stimulator, can be prevented from occurring. In addition, in some examples, the stimulator memory will generate an activity log for recording the use and / or errors of the stimulator during treatment. The stimulator log can include a list of errors that occurred, along with a timestamp of the time the error occurred, a history of the time of use, including the amplitude and / or stimulation parameter settings used. These features are very important for ensuring that patients can effectively use stimulation and / or clinicians can effectively monitor their stimulation use.

[0133] An example disengagement mechanism may include a socket portion including a wire / lead contact point. The socket portion may include any suitable example of a magnet including the contact point. The socket portion may include a ferromagnetic stator that may act as a path retainer. The mating portion of the disengagement mechanism may include a plug. The plug may include a ferromagnetic retainer path and contacts. The leads may be operably attached to the plug.

[0134] The disengagement mechanism may comprise a spring-loaded plunger mechanism. The plunger mechanism utilizes a pair of biasing members that can push the plungers toward each other when the plug is inserted into the socket. This can hold the disengagement mechanism together. The force used to hold the disengagement mechanism together is defined such that any amount of force applied to the system exceeding this force will cause the plug to separate from the socket, for example, if there is force applied to the lead because it is caught on something. This will generally protect the system. In particular, it will generally prevent the leads and / or electrodes from becoming disengaged and / or moving from their intended positions.

[0135] Described herein are examples of systems for testing, positioning, introducing, and / or deploying leads for percutaneous peripheral nerve stimulation, the systems comprising a percutaneous cannula, a stimulation probe, a lead, and / or an introducer. Without changing the referenced components, the percutaneous cannula may also be referred to as an introducer sheath or introduction sheath. Without changing the referenced components, the stimulation probe may also be referred to as a test needle or test needle. Without changing the referenced components, the introducer may also be referred to as an introduction needle or introducer needle. The percutaneous cannula and / or introduction sheath may advantageously comprise a hub and a shaft having an inner cavity, the distal portion of the sheath forming an end opening. The stimulation probe or test needle may advantageously comprise a hub and a shaft, the distal end of the shaft may incorporate one or more bevels, and the shaft having an outer diameter that is sufficiently small so that it can enter the inner cavity of the percutaneous cannula with minimal friction, but avoids sufficient space between the two components during insertion into the skin, muscle, and / or other tissue so that tissue can be sandwiched between them. The introducer can advantageously be comprised of a hub and shaft having a lumen of sufficient diameter to enable the stimulation lead to reside therein and / or pass through it, the distal portion of the needle being comprised of one or more bevels forming a terminal opening, the outer diameter of the introducer needle shaft being sufficiently smaller than the diameter of the lumen of the percutaneous cannula such that the introducer with the stimulation lead therein and an anchor secured to the edge of the introducer lumen can be inserted through the lumen of the percutaneous cannula while avoiding damage and / or destruction of the stimulation lead.

[0136] Described herein are example systems for testing, positioning, introducing, and / or deploying leads for percutaneous peripheral nerve stimulation that include, in part, a percutaneous cannula, a stimulation probe, a lead, and / or an introducer. The percutaneous cannula and / or introduction sheath can advantageously be comprised of a hub and a shaft having an inner lumen, a distal portion of the sheath forming an end opening. The stimulation probe and / or test needle can advantageously be comprised of a hub and a shaft, the distal end of the shaft can incorporate one or more bevels, and the shaft having an outer diameter such that it can be inserted into and / or passed through the inner lumen of the percutaneous cannula while avoiding friction that would prevent the components from being moved, while avoiding disrupting the position of the cannula, and also while avoiding catching tissue between the two components during insertion into the skin, muscle, and / or other tissue. The introducer can advantageously be comprised of a hub and shaft having an inner lumen of sufficient diameter to enable the stimulation lead to be carried therein and / or advanced therethrough, the distal portion of the needle being comprised of one or more bevels forming an end opening, the outer diameter of the introducer needle shaft being sufficiently smaller than the diameter of the inner lumen of the percutaneous cannula so that the introducer with the stimulation lead therein and an anchor secured to the edge of the introducer inner lumen can be inserted through the inner lumen of the percutaneous cannula while avoiding causing damage and / or destruction to the stimulation lead.

[0137] As a non-limiting example, an introducer sheath can be inserted together with a test needle, which can be embodied as a solid metal needle with no lumen retained within it. A stimulation test can then be delivered via the test needle, and / or the system can be freely repositioned as needed while avoiding the need to deploy leads. Once the ideal position is found, the test needle will be withdrawn while the introducer sheath remains in place. The introducer needle (with lead) can then be inserted through the lumen of the introducer sheath. Both the introducer sheath and the introducer needle can then be withdrawn together to deploy the lead.

[0138] In one non-limiting example, a percutaneous cannula can be combined with a hypodermic needle having an outer diameter of approximately 1.49-1.51 mm, 1-2 mm, and / or 0.5-2.5 mm outer diameter, and an inner diameter of 1.36-1.4 mm, 1.01-1.99 mm, and / or 0.51-2.49 mm. The length of the needle portion of the cannula can be 90-100 mm, 60-130 mm, and / or 30-160 mm in length. In some examples, the length of the needle will be sufficient to enable targeting deeper nerves (e.g., the sciatic nerve) in larger patients. In some examples, the length of the needle can be minimized so that the torque from the weight of the hub is reduced when targeting shallower nerves (e.g., the femoral nerve), thereby reducing the tendency of components to interfere with the final position of the needle tip and lead.

[0139] In one non-limiting example, the stimulation probe can have an outer diameter such that it functions as a non-coring insert when within a percutaneous cannula (e.g., in one non-limiting example, an outer diameter of 1.3-1.4 mm if the introducer cannula has an outer diameter of 1.49-1.51 mm). The length of the needle portion of the stimulation probe can be approximately 120-125 mm, 70-150 mm, and / or 35-180 mm in length. In some examples, the length of the stimulation probe is longer than the percutaneous cannula so that test stimulation can be delivered through the electrode portion of the stimulation probe.

[0140] In one non-limiting example, the introducer needle can have an outer diameter such that, with the anchor of the lead fixed to the edge of the distal lumen edge, the introducer needle and the lead anchor can pass through the percutaneous cannula lumen while avoiding damage to the lead anchor. The outer diameter of the introducer needle can desirably be 0.902-0.914 mm, 0.7-1.1 mm, and / or 0.35-2.35 mm. In some examples, the inner diameter of the introducer needle can desirably be 0.749-0.800 mm, 0.5-1 mm, and / or 0.3-2.3 mm. The inner diameter of the percutaneous cannula must be large enough to allow the body of the lead to reside therein and be withdrawn therefrom. The length of the needle can be approximately 120-130 mm, 70-150 mm, and / or 35-180 mm in length. In some examples, the introducer needle is longer than the percutaneous cannula so that the entire anchor of the lead extends beyond the distal end of the percutaneous cannula into the tissue, thereby enabling the lead to be deployed.

[0141] An anchor for the lead bent over a first edge of the distal opening of the introducer needle may cause the lead to engage tissue, causing the lead to self-anchor upon withdrawal of the introducer needle.

[0142] The test needle need not have an inner lumen (i.e., it can be a solid needle), which can advantageously avoid tissue coring, tearing, and / or other types of tissue damage. The test needle can be made of any conductive material that can maintain a sharp tip and can be safely inserted into the human body and / or is biocompatible. The test needle can also be made of a non-conductive material if some portion of the test needle and / or components therein are capable of conducting electricity. As some skilled in the art will be able to discern, many materials, including various metals, meet these requirements. In some examples, the test needle can be made of stainless steel.

[0143] The introducer needle and / or the test needle may have one or more bevels. Having one or more bevels is desirable because it enables the needle to be inserted into tissue, avoiding the need to use any surgical (and / or other) tools (e.g., a scalpel).

[0144] In some examples, the conductive test needle may have an integrally connected electrical connector, i.e., a plug that may be integrally connected via one or more lengths of cable. The electrical connector may desirably mechanically and / or electrically mate with the needle. Integrating the plug into the hub of the test needle may avoid the need for an external connector component to facilitate stimulus delivery during testing.

[0145] The conductive test needle and / or stimulation probe may be coated with an insulating material except for an exposed conductive portion of the needle proximal to and including or not including the distal-most tip of the needle. This exposed portion enables a test stimulus to be delivered through the test needle. In one non-limiting example, the electrically exposed portion of the needle and / or the electrode may have a surface area of 1-10 mm2. In another non-limiting example, the electrode may have a surface area of 10-100 mm2. In yet another non-limiting example, the electrode may have a surface area of 100-500 mm2.

[0146] The introducer needle can have an electrical connector that is integrally mated to the conductive introducer needle so that the electrical connector is mechanically and / or electrically mated to the needle. Having the plug built into the hub of the introducer needle avoids the need to use an external connector component to stimulate through the lead. The conductive introducer needle can be coated with an insulating material and include or, preferably, exclude an end opening other than the exposed conductive portion of the needle. In one non-limiting example, the electrically exposed portion of the needle and / or the electrode can have a surface area of 1-10 mm2. In another non-limiting example, the electrode can have a surface area of 10-100 mm2. In yet another non-limiting example, the electrode can have a surface area of 100-500 mm2. The exposed portion enables a test stimulus to be delivered through the needle tip. Because the needle tip also contacts the lead electrode and / or anchor, the stimulation is delivered through the lead.

[0147] The introducer sheath, test needle and / or introducer needle can incorporate an ergonomic, lightweight hub at the proximal end having a textured surface that provides grip and control during insertion into tissue and / or adjustment within tissue. The hub can be attached to the needle in a variety of ways, including welding, crimping, gluing and / or overmolding. The proximal surface of the needle can be roughened to facilitate the integration of the hub into the needle. An ergonomic hub is important because it allows for better control of the needle during insertion, especially in patients with harder skin, where inserting the system can be challenging without a suitable location to grip the introducer system. Minimizing the weight of the hub is important because when it is left in place during testing, this part of the system provides the greatest torque to the system, easily distorting / displacing tissue and / or potentially creating a difference between stimulation during testing and after lead deployment.

[0148] A non-limiting example of a lightweight hub may desirably be one whose weight avoids generating a torque on the system that causes the needle tip to displace more than 0.25 mm, 1 mm, and / or 5 mm when one-third or more of the needle's length is indwelling in tissue. Another non-limiting example of a lightweight hub may desirably be comprised of a hub whose weight does not exceed one-quarter, one-third, one-half, three-quarters, and / or nine-tenths of the total weight of the components.

[0149] The hub of the test needle and the hub of the introduction sheath can be reversibly locked or connected together by means such as snaps, twist locks and / or other means to form a temporary connection. Enabling the test needle and introduction sheath to be locked together ensures that the components remain in the proper position relative to each other during insertion, testing and / or repositioning. This locking mechanism can be reversible so that once the correct position is determined, the test needle can be withdrawn through the introduction sheath and the position of the introduction sheath can be avoided. In one non-limiting example, one or more tabs or protrusions on the hub of the stimulation probe can be mounted into grooves and / or keyways in the hub of the percutaneous cannula, enabling the hubs to be mated together by a small twisting of the two components relative to each other. This mechanism can reduce the force applied along the length of the needle, the force required to unlock the two components from each other, which in turn avoids displacement of the percutaneous cannula from the target position.

[0150] The hub of the introducer needle and the hub of the introducer sheath can be reversibly or irreversibly locked and / or connected together by means such as snaps, twist locks, and / or other means to form a temporary and / or permanent connection. Enabling the introducer needle and introducer sheath to lock together ensures that the components remain in proper position relative to each other during lead insertion and / or deployment. Such locking mechanisms may not be readily reversible because once the introducer needle is fully inserted into the introducer sheath, both may be withdrawn together during lead deployment.

[0151] All materials of the system can be biocompatible and / or lightweight, with plastic being a preferred complement to steel components. Furthermore, the hub / handle can be sufficiently balanced and / or weighted to enable one-handed manipulation of the system. To this end, some examples herein can advantageously ensure that the probe and needle are as similar as possible in length, weight, and / or feel. Gripping rings, flange wings, and / or contours within the handle itself can also be provided to enhance overall usability.

[0152] The locking mechanism enables a reversible or irreversible connection between the connector and the hub / handle of the corresponding component.In each case, the connector is coupled to a proximal wire extending out of the component.

[0153] What has been described above includes examples for this specification. Of course, for purposes of describing this specification, it is not possible to describe every conceivable combination of parts or methods, but one of ordinary skill in the art will recognize that many further combinations and permutations of this specification are possible. Each of the components described above may be combined or added together in any arrangement to define an introducer system. It is therefore intended that this specification encompass all such changes, modifications and variations that come within the spirit and scope of the appended claims. Furthermore, to the extent that the term "comprising" is used in the detailed description or the claims, such term is intended to be inclusive in a manner similar to the term "comprises" as it is interpreted when used as a transitional word in a claim.

[0154] Challenges addressed by the systems and methods herein include minimizing and / or mitigating forces or risks on implanted leads, cables, and / or other connected components to keep the forces on the leads and / or their directly connected system components sufficiently low to prevent the leads from shifting, migrating, breaking, damaging, and / or permanently deforming, while maintaining electrical and mechanical connectivity during, but not limited to, daily use, connection and / or disconnection, periods of activity, bathing, and / or sleeping, and / or while performing bandage changes to care for the exit site of a percutaneous lead so as to adequately maintain delivery of therapeutic stimulation. As a non-limiting example, a system component may maintain consistent mechanical and electrical connectivity during motion such as walking, but if a component (e.g., a cable) were to become caught on a door handle during that motion, the sudden force on the system would cause the component to disconnect rather than shift, break, cause migration, and / or permanently deform the percutaneous lead. In another non-limiting example, if a system component becomes caught on the patient's clothing while dressing, the system component may be disconnected to prevent displacement, breakage, migration, and / or permanent deformation of the percutaneous lead, but may remain connected during movement (such as moving from standing to sitting) to maintain mechanical and electrical connections and reduce interruptions during treatment.

[0155] The system may include one or more separation (e.g., disconnect) mechanisms along the cable and / or connector to reduce inadvertent transmission of forces along the implanted lead, but avoid unnecessary interruptions in therapy. The described system can overcome the challenges of limiting undesirable or accidental forces on the percutaneous lead while maintaining consistent mechanical and electrical connections by incorporating separation and / or disconnect points (e.g., pre-planned, pre-designated, preferred, and / or intentional disconnect points, areas, or locations) at one or more components or locations that may be subject to an increased number and type of forces that could cause displacement, breakage, migration, damage, and / or permanent deformation of the percutaneous lead, including but not limited to unintentional adhesion to a bandage during bandage changes, snagging on external objects (e.g., clothing) or other components of the system, and / or from standard , nonstandard, expected, unexpected, and / or unusual body movements (e.g., limb flexion or extension, moving from standing to sitting, and from sitting to standing), but at the same time enabling continuity of therapy delivery by maintaining optimally strong enough (e.g., strong enough but not too strong) mechanical and electrical connections between components to limit therapy interruptions, user frustration (e.g., having to reset and / or restart stimulation after unnecessary component disconnection), and / or ineffective therapy (e.g., reduced or shortened therapy time through the patient's inability to identify a disconnected component or to reset / restart stimulation after a component disconnection). In a non-limiting example, a length of cable that passes under or beneath a bandage (and therefore has an increased risk of entrapment during bandage changes) can include not only a breakaway mechanism (e.g., a magnet) on the portion of the cable outside the bandage to limit the transfer of force to the percutaneous lead if the cable accidentally becomes snagged or pulled, but can also include an additional breakaway mechanism (e.g., a magnet) on the portion of the cable inside the bandage so that if the portion, section, or length of cable that passes under the bandage is inadvertently pulled during (planned and / or unplanned, partial or full) removal of the bandage, it can be released from the lead connector and prevented from transferring force to the percutaneous lead that could otherwise cause the lead to become dislodged, break, migrate, become damaged, and / or permanently deform. The described breakaway mechanisms can include, but are not limited to, magnets and can be located anywhere along the cable and / or lead connector outside, inside, or beneath the bandage.

[0156] The systems and methods described herein overcome the challenges of connecting small (e.g., optimally less than 1.0 mm in size, and more preferably less than 0.7 mm) flexible leads to a generator via a cable during intraoperative testing by designing novel mechanical and electrical connections to the microleads that can be performed while wearing surgical gloves and / or single-handed to expedite surgical time while limiting the chance of the electrode moving from its initially intended position (e.g., inadvertently dragging the lead while making the connection). In some examples, the mechanical and electrical connections to the percutaneous fine-wire leads can include ridges, grooves, and / or bumps that protrude an amount to provide adequate traction when held with a gloved hand that may become soiled by ultrasound gel and / or other materials present during surgery, but avoid sharp edges or protrusions so much that the ridges, grooves, and / or bumps compromise sterility and / or waterproof dressings, or cause discomfort to a patient using the system. In some examples, the mechanical and electrical connections to the percutaneous fine-wire leads can be of sufficiently small size (e.g., less than 3 cm in length and / or width), with a sufficiently shallow profile (e.g., 0.3-1 cm) to fit comfortably beneath a waterproof and / or protective bandage, but large enough to be comfortably held in a gloved hand and potentially become soiled by ultrasound gel and / or other materials present during the surgical procedure.

[0157] The lead connector can be designed to make mechanical and electrical connections to thin wire leads while wearing surgical gloves (which may become soiled with, for example, ultrasound gel) and / or single-handed during intraoperative testing to speed up surgical time while limiting the chance of the electrode moving from the initially intended position (e.g., by inadvertently dragging the lead while making the connection). The described system can include channels, grooves, or tunnels into which the lead can be fed, wrapped, and / or routed to enable the conductive teeth and / or barbs to penetrate the insulating barrier coating of the lead while avoiding damage or severing the conductive wire or conductor, strand, filament, and / or cable within or including the lead. In one example, the lead can be secured in place in the aforementioned channels, grooves, and / or tunnels of the connector by pressing a hinged flap closure and a flexible molded snap into place to hold the flap closed, and / or the hinged flap can be secured in place by the tension of a spring, and / or the hinged flap can be secured in place by a rotating (e.g., locking) mechanism. In another example, the leads can be secured in place within the channels, grooves, and / or tunnels of the connector by folding and / or wrapping material (e.g., flexible silicone, plastic clips) over the leads. In another example, the leads can be secured in place within the channels, grooves, and / or tunnels of the connector by sliding drawers and / or trays, slots, and / or sliding mechanisms, which can be secured in place by flexible moldings that snap into place, spring tension, and / or rotating (e.g., locking) mechanisms. Releasing the leads secured within and / or to the connector may require a two-finger pinch (e.g., pressing inward on both sides of the connector), a tab pulled down and / or away from a securing molded lip, spring displacement, rotation of one surface (e.g., against a groove), and / or use of a key.

[0158] The connector may be held in place to avoid pulling and / or dragging on the lead due to movement or displacement of the connector by the bracket or support under dressing or during bandage changes.

[0159] In some examples, the bandage can be designed to maintain a waterproof seal between the lead exit site and the external environment while maintaining breathable (e.g., allowing water to escape while allowing oxygen to enter) properties. The bandage can include a non-stick center to cover the lead exit site and the exterior of the lead (e.g., after percutaneous placement, with part of the lead inside the body and part of the lead outside the body), while incorporating an adhesive outer edge to repel water. A connector can penetrate the waterproof bandage to provide an electrical connection between the lead and the generator's cable while maintaining waterproofness by adhering, clamping, suctioning, and / or locking into the bandage component. The bandage can be composed of a structural protective component and a waterproof adhesive component.

[0160] The bandage can enable and / or facilitate electrical connection between the lead exit site and the cable of the generator while limiting the stress applied to the lead that may cause the electrode to shift, break and / or move from its initial position while maintaining a protective barrier between the lead exit site and external forces and / or external contaminants or microorganisms. In some examples, the cable can be passed under an adhesive bandage that is flexible enough to fold around the cable and hold it in place while preventing damage to the bandage's waterproofness. In another example, the channel and / or tunnel can secure the cable in place by enabling the cable to pass through a shaped (e.g., thermoformed plastic or silicone) protective cover and / or through a flexible (e.g., foam) protective ring surrounding the lead exit site. The protective cover and / or ring may adhere to the skin itself, or an adhesive bandage may need to be placed over it. In some examples, the channel and / or tunnel can secure the cable radially away from the lead exit site (e.g., by enabling the cable to be secured between the protective cover and / or ring and the skin surface). In another example, the channel can pass through the body of the protective cover and then radially out under a waterproof bandage that is flexible enough to fold around the cable and maintain a waterproof seal, and / or can pass through both the body of the protective cover and the body of the waterproof bandage and adhere, clamp, suction and / or lock to maintain a waterproof seal. In another example, a magnet (and / or multiple magnets) can be molded, fixed and / or adhered to the protective cover to secure the cable passing through the protective cover and limit the transmission of forces that may apply undesirable stress to the lead and / or lead exit site. In a non-limiting example, such a magnet can secure a cable outside the protective cover and / or waterproof seal to or through a conductive entry in the protective cover and / or waterproof seal. The force of the magnet may be less than the force required to displace, break or otherwise move the lead from its intended position, so that an unintentional tug or pull on the cable may cause the magnetic connection to release and avoid transmitting force to the lead. In another non-limiting example, such magnets can secure a cable to, through, or under a protective cover and / or waterproof bandage and release to avoid transferring undesirable forces (e.g., an undesirable tug or pull on the cable) to the leads without affecting the stimulation circuit (e.g., a cable that could affect the stimulation circuit can be attached to, through, or a magnet under a protective cover that is not a stimulation circuit component).

[0161] As non-limiting examples, one or more portions of the protective cover and / or waterproof seal can include one or more conductive materials or have one or more conductors or conductive wires, strands, filaments, and / or cables, such that the cables and / or wires do not need to be passed through the bandage (which may or may not be waterproof and / or water-resistant) and / or under the bandage, and instead electrical signals can be passed between the external pulse generator and the lead via such conductive materials or conductors. The cable can be adhered to such conductive material via a mechanism (such as a snap, magnet, suction, and / or adhesive) and can be disconnected at a specified or pre-specified force or range of forces (e.g., at a force less than the force required to displace, break, and / or otherwise move the implanted lead from its original position).

[0162] As non-limiting examples, the bandage can be used, designed, and / or integrated with other system components and / or the entire system to overcome, alleviate, reduce, and / or address the effects of the bandage on the patient's daily activities (e.g., dressing and undressing, using the toilet, ascending and descending stairs, sitting, standing), exercise (e.g., moving from sit to stand, from stand to sit, housework, yard work), physical activity (e.g., exercise, sports, stretching), and / or sleep (e.g., when the patient moves and / or turns over unconsciously, and / or when additional blankets, sheets, and / or clothing may be placed around the patient). The invention relates to a method for preventing the use of a lead and / or electrode in a lying position from causing unintentional and / or unwanted lead displacement, breakage and / or movement of the lead and / or electrode from its intended position, and / or when less clothing may hold the cable and / or bandage in place, and / or when greater motion and / or movement may be required to move from a lying position to a sitting position or vice versa, and to prevent unintentional and / or unwanted lead displacement, breakage and / or movement of the lead and / or electrode from its intended position, to avoid, but not limited to, flaking of the bandage edges, sticking of the bandage to bed sheets and / or clothing, and / or movement of the bandage due to, for example, moisture, water, lotions, oils and / or sweat. In a non-limiting example, the edges of the bandage may be coated with a strong adhesive and / or reinforced with a fabric-like material. In another non-limiting example, an additional bandage may be provided in conjunction with the original bandage for use at night and / or during strenuous activity. In some examples, such a bandage may provide an additional barrier between the original bandage and bed sheets and / or clothing. In some examples, such a bandage can include additional padding and / or compression to reduce force transfer due to unintended weight transfer to / from the lead exit site. In some examples, the bandage can be made of a material that provides a cooling sensation and / or wicks sweat away from the original bandage (e.g., by wicking moisture).

[0163] Other non-limiting examples of connector-lead interaction can include straightening the lead or coiling the lead. Coiling the lead can allow the coiled portion to act as a shock absorber. On the other hand, straightening the lead may cause the connector to cause the lead to begin interacting like a rope rather than a coil. Additionally, the number of blades contacting the connector / lead may result in different performance. For example, too few blades may result in an electrical connection that may not remain secure during long-term home use. Too many blades may reduce the integrity of the lead and / or connector. Additionally, the type of blade interaction that exerts pressure or force on the rest of the connector / lead and the presence or absence of a spring-like force may affect performance. For example, the absence of a spring-like force may reduce the amount of force required to pull the lead from the patient. Additionally, the pressure on the blades can be adjusted to be less than the force required to displace the lead from the patient / user. Furthermore, instead of magnetic force, friction can help mechanically secure the lead and connector in place.

[0164] If the system includes too many blades, it may make handling, use, and closing the connector on or to the lead too difficult, which may affect the user's ability to operate the connector with one hand, and ideally with two fingers (e.g., index finger and thumb). The importance of the limitation that the user may be able to apply only a limited amount of force due to the need to use friction to close the device may be greatly limited because the user (e.g., clinician) may be wearing gloves and / or covering or coating their hands or gloves with a lubricating liquid, gel, or material (such as ultrasound gel) that may lubricate critical surfaces and reduce the amount of force that can be applied to the connector, thereby limiting the amount of force that can be used to close the connector and cause the blades to interact with the remaining applicable portions of the connector and properly mechanically and electrically connect to the lead.

[0165] Overcoming usage challenges and enabling closure of the connector on leads is important because the connector will preferably be closable with one hand and ideally used or operated with two fingers (eg, index finger and thumb).

[0166] Figure 1 An adhesive pad 100 is shown configured to engage between a connector 102 and the skin of a patient. The adhesive pad 100 includes an adhesive strip 104 configured to attach to the connector 102 to secure the connector 102 to the adhesive pad 100. In the example shown, the adhesive strip 104 has a removable cover 106 that protects the adhesive strip 104 until it is coupled to the connector 102. Figure 1 In the example shown, the adhesive strip 104 is configured to adhere to the connector 102. Alternatively, in some examples, the adhesive strip 104 adheres to a connector base (described below).

[0167] Figure 2A connector base 200 (sometimes referred to as a "connector bracket" or "bracket") is shown that is configured to slidably engage a connector 202. Figure 2 In the example of Figure 1 The adhesive pad 100 is attached to the patient. In the example shown, the connector 202 has an integrated cable 204. However, the connector 202 can be any connector described herein. The connector 202 provides an interface between the cable 204 and the connector 202. The cable 204 is electrically coupled to a neurostimulation device (not shown) to provide stimulation signals to the lead 206 via the cable 204.

[0168] In the illustrated example, the connector 202 includes a snap tab 208. In some examples, the snap tab 208 is integrally formed with the body of the connector 202. The snap tab 208 includes a head 210 that is configured to slide into a channel 212 defined by the connector base 200 and snap into an aperture 214 defined by the connector base 200. The connector base 200 is at least partially flexible to accommodate insertion and removal of the connector 202. For example, to remove the connector 202, the connector base 200 can be subjected to a force perpendicular to a wall 216 of the connector base 200 to facilitate removal of the head 210 of the snap tab 208 from the aperture 214.

[0169] Figure 3A 、 Figure 3B and Figure 3C Another example connector 300 is shown slidably engaged with a connector base 302. Figure 3A 、 Figure 3B and Figure 3C In the example of FIG. Figure 1 The adhesive pad 100 is attached to the patient. In the example shown, the connector 300 has an integrated cable 204. However, the connector 300 can be any connector described herein. The connector 300 provides an interface between the cable 204 and the connector 300. The cable 204 is electrically coupled to a neurostimulation device (not shown) that provides stimulation signals to the lead 206 via the cable 204.

[0170] The connector base 302 includes three side walls, a top wall, and a bottom foot to provide a connection surface with the adhesive pad 100. The connector base 302 is configured to surround the connector 300 together with the adhesive pad 100 to prevent or block the connector 300 from being attached to a bandage or transparent dressing (such as TEGADERM TM306 is located on a side wall of the connector base 302. However, alternatively or additionally, in some examples, the cable cutout 306 can be located on the top wall of the connector base 302 to accommodate a connector having a cable interface on the top of the connector (e.g., see below). Figure 21A 、 Figure 21B and Figure 21C connector in the .

[0171] Figure 4A 、 Figure 4B 、 Figure 4C 、 Figure 4D and Figure 4E An example connector 400 is shown that can be vertically locked with a connector base 402. Figure 4A 、 Figure 4B 、 Figure 4C 、 Figure 4D and Figure 4E In the example of Figure 1 The adhesive pad 100 is attached to the patient. In the example shown, the connector 400 has an integrated cable 204. However, the connector 300 can be any connector described herein. The connector 400 provides an interface between the cable 204 and the connector 400. The cable 204 is electrically coupled to a neurostimulation device (not shown) that provides stimulation signals to the lead 206 via the cable 204.

[0172] In the example shown, the connector 400 is removably engaged with the connector base 402 by vertically aligning the connector 400 with the connector base 402 and pressing downward until the connector 400 snaps into the connector base 402. The snap fit between the connector 400 and the connector base 402 via the push-down helps to secure the connector 400 without pulling on the leads 206 and prevents or inhibits the connector 400 from shifting during use. In the example shown, the connector 400 includes a connecting wing 404 that defines a connecting slot 406. The connecting portion 408 that bridges the connecting wing 404 with the body 410 of the connector 400 is flexible or semi-ridged, allowing pressure to be applied to the top of the connecting wing 404 to temporarily deform the connecting portion 408 (e.g., as shown in FIG. 2 ). Figure 4E4 (shown) to facilitate removal of the connector 400 from the connector base 402. The connecting wings 404 each define a tab slot 412 that is configured to lock the connector 400 into the connector base 402. In the example shown, because the connector 400 includes an integrated cable, one of the connecting wings 404 defines a cable slot 414 to accommodate the cable 206.

[0173] The connector base 402 includes a body 416 configured to receive the body 410 of the connector 400. The connector base 402 also includes protective walls 418, each of which at least partially surrounds a snap tab 420 (sometimes referred to as a "claw") that is configured to snap into the tab slot 406 of the connector 400 to snap the connector 400 into the connector base 402.

[0174] Figure 5A and Figure 5B A molded connector base 500 is shown that is configured to receive a connector (e.g., any of the connectors described herein). In the example shown, the connector base 500 is a molded silicone pad into which the connector 204 and leads are press-fitted. In the example shown, the connector base 500 defines a lead channel 502 that is configured to receive leads (e.g., Figure 2 206, etc.) such that when the bandage or transparent dressing is removed, the leads are protected from removal and / or displacement. In the example shown, the connector base 500 defines a cavity 506 that is configured as a snap or friction fit connector such that when the bandage or transparent dressing is removed, the cables are protected from removal and / or displacement. In some examples, the molded connector base 500 defines a cable channel 508 that is configured to receive a cable (e.g., Figure 2 The connector base 500 may be provided with a protective layer (not shown) on the bottom to adhere the connector base 500 to the patient's skin. In such an example, the connector base 500 may include a tab 510 without adhesive to facilitate removal of the connector base 500.

[0175] Figure 6A 、 Figure 6B 、 Figure 6C 、 Figure 6D 、 Figure 6E and Figure 6F An exemplary connector 600 is shown that is configured to mate with a detachable cable. Figure 6A 、 Figure 6B 、 Figure 6C 、 Figure 6D 、 Figure 6E and Figure 6FAn example mating interface is shown in , but example connector 600 can use any connector port (sometimes referred to as a "mating interface") described herein. The examples shown generally describe examples of the form of connectors. Figure 6A and Figure 6B Also shown is a lead anchor 601. Lead anchor 601 can be any of the lead anchors discussed herein. Lead anchor 601 secures lead 206 at or near the mounting site to prevent or inhibit movement of lead 206. Connector 600 provides a connection point so that cable 204 can be attached and detached with minimal movement of lead 206. As with other connectors described herein, connector 600 can be molded or formed from a thermosetting polymer (e.g., ABS). In some examples, the material selected is dielectric, sufficiently strong to remain fixed to an auxiliary component, and capable of being sterilized.

[0176] In the illustrated example, connector 600 includes a base 602 and a cover 604. Base 602 and cover 604 are rotatably connected via a hinge or axis 606. In the illustrated example, base 602 and cover 604 are rotatably connected along the longer sides so that the axis of rotation is substantially parallel to lead 206 when lead 206 is inserted into connector 600. The base includes a plurality of sidewalls 608 and a bottom plate 610. When cover 604 is installed, an internal cavity 612 is formed. Lead 206 is received into cavity 612 through ports 614 and 616. When cover 604 is closed, a space 618 can be defined between base 602 and cover 604 to facilitate release of locking clips 620 formed on cover 604 from their cooperating claws 622 defined by base 602.

[0177] The body 602 defines a lead cavity 624 between ports 614 and 616 to receive the lead 206. In operation, the lead 206 is placed in the lead cavity 624, extending beyond at least one of the ports 614 and 616. The body 602 defines a blade cavity 626 perpendicular to the lead cavity 624 to receive one or more blades (not shown), which are fixed to the underside 628 of the cover 604 at the cable port 630. Although the blades are not shown for simplicity, example blades are described in International Application No. PCT / US2019 / 046855, entitled "Electrical Stimulator for Peripheral Stimulation," filed on February 12, 2021, which is incorporated by reference in its entirety. The blades are electrically coupled to the cable port 630. When a cable (e.g., cable 204) is connected to the cable port 630 and the cover 604 is closed, the cable is electrically coupled to the lead 206 via the cable port 630 and the blades.

[0178] In the example shown, the body 602 includes a connection wing 632. The connection wing 632 is an example of the connection wing 404 of FIG. However, in other examples, the connector 600 can be configured to operate with different types of connector bases, such as Figure 2 or Figure 3A 、 Figure 3B and Figure 3C Sliding connector base, or Figure 5A and Figure 5B molded connector base.

[0179] The cover 604 has a generally flat, planar shape. The cover 604 includes a cable port 630. The cable port 630 can be any of the cable ports described herein. The cover 604 integrally forms a locking clip 620 to facilitate securing the cover 604 to the base 602. In the illustrated example, the cover defines ports 634 and 636 that correspond to and align with ports 614 and 616. The cover 604 is then closed, with at least a portion of the lead 206 positioned within ports 634 and 636 to provide, for example, a secure hold on the lead 206. Each clamp 310 includes a claw edge at the distal end of the ramp. The claw edge snaps onto the claw 622, while the ramp provides a resting position on the claw 622 to provide, for example, a closed but unlocked configuration.

[0180] Figure 7A 、 Figure 7B 、 Figure 7C and Figure 7D An example push-lock connector 700 is shown. In the example shown, the push-lock connector 700 is configured to mate with a slidably engageable connector base, such as Figure 3A 、 Figure 3B and Figure 3C The push lock connector 700 includes a body 702 and an insert 704. The push lock connector 700 has an open position and a closed position determined by the relative position of the insert 704 with respect to the body 702. Figure 7A and Figure 7B In the example shown, the push-to-lock connector 700 is in an open position, wherein the insert 704 is not within the body 702 to lock the leads 206. Figure 7C and Figure 7D In the illustrated example, the push-to-lock connector 700 is in a closed position with the insert 704 within the body 702 to lock the leads 206 .

[0181] In the illustrated example, the cable 204 is incorporated into the body 702. However, the body 702 can be configured with any of the mating interfaces described herein. The body 702 defines a lead channel 706 for receiving the leads 206. The body 702 also defines an inner cavity 708 having guide tabs 710 that are configured to engage corresponding guide channels 712 of the insert 704 to facilitate insertion of the insert 704 into the body 702. The body 702 includes one or more blades (not shown) that are electrically coupled to the cable 204. When the push-to-lock connector 700 is in the closed position, the blades are mechanically and electrically coupled to the leads 206 within the lead channel 706 to provide an electrical connection between the cable 204 and the leads 206.

[0182] The insert 704 defines a guide channel 712 and a lead port 714. The guide channel 712 cooperates with the guide tabs 710 of the body 702 to facilitate insertion of the insert 704 into the body 702. When the insert 704 is inserted into the body 702, the lead port 714 receives the lead 206 positioned in the lead channel 706 of the body 702. When the insert 704 is substantially inserted into the body 702 and the connector 700 is in the closed position, the end wall 716 of the lead port 714 holds the lead 206 against the blade and locks the lead 206 into the connector 700. Thus, when the lead 206 is in the lead channel 706 and the insert 704 is substantially inserted into the body 702, the lead 206 is secured in the body 702 and electrically coupled to the cable 204.

[0183] Figure 8A 、 Figure 8B and Figure 8C An example foldable lead anchor 800 is shown for securing the lead 206 to the patient to prevent or inhibit movement of the lead 206 at the installation site. Figure 8A and Figure 8B In the illustrated example of FIG, the leads 206 are coupled to a connector 800, which is attached to a connector base 802. The connector base 802 is connected to the connector base 802 via Figure 1 The adhesive pad 100 is attached to the patient. In the example shown, the foldable lead anchor 800 is configured to be attached to the patient via suture 804.

[0184] Foldable lead anchor 800 includes a first side member 806A and a second side member 806B (collectively referred to as "side members 806") connected at a connection point 808. Foldable lead anchor 800 is sufficiently flexible such that when foldable lead anchor 800 is folded at connection point 808, inner surfaces 810A and 810B of respective side members 806 can contact. Foldable lead anchor 800 defines a lead channel 812 between side members 806 that is configured to receive a lead 206. Lead 206 is clamped within lead channel 812, and foldable lead anchor 800 is then folded within lead channel 812 by a clamping member 814 attached to one or more side members 806. The side members 806 define suture holes 816 that are configured to be used to suturing the foldable lead anchor 800 to the patient when the foldable lead anchor 800 is folded around the lead 206 . Figure 8C The illustrated example of shows two sets of aligned suture holes 816, each set having two suture holes 816. However, in some examples, the side members 806 can define more than two suture holes 816. When installed, the side members 806 are folded with the leads 206 in the lead channels 812 such that the inner surfaces 810A and 810B contact and the suture holes 816 of the first side member 806A are aligned with the suture holes 816 of the second side member 806B.

[0185] Figure 9A and Figure 9B An example snap-on lead anchor 900 is shown for securing the lead 206 to the patient to prevent or inhibit movement of the lead 206 at the installation site. The snap-on lead anchor 900 may be used in conjunction with any of the connectors described herein. Figure 9A The snap-on lead anchor 900 is shown in an open position. Figure 9B The snap-in lead anchor 900 is shown in a closed position. In the example shown, the snap-in lead anchor 900 includes a first side member 902, a second side member 904, and a connecting member 906.

[0186] Side members 902 and 904 are configured to be placed directly or indirectly on a patient and sutured to the patient. Side members 902 and 904 define suture holes 908 to facilitate suturing snap-on lead anchor 900 to the patient. In the illustrated example, a portion 910 of side members 902 and 904 is angled toward and attached to connecting member 906 to facilitate, for example, opening and closing of connecting member 906.

[0187] Connecting member 906 receives lead 206 and prevents or inhibits movement of lead 206 when connecting member 906 is closed. Connecting member 906 defines a first arm 912 and a second arm 914. First arm 912 and second arm 914 are attached at a flexible joint 916. First arm 912 and second arm 914 define a lead channel 918 at flexible joint 916 to receive lead 206 when snap-on lead anchor 900 is opened. When snap-on lead anchor 900 is closed, first arm 912 and second arm 914 together clamp lead 206 to prevent movement of a portion of lead 206 within connecting member 906. In the illustrated example, to lock connecting member 906 in the closed position, first arm 912 includes a locking clip 920, and second arm 914 defines cooperating jaws 922. When first arm 912 and second arm 914 are pressed together, locking clip 920 inserts into and locks into cooperating jaws 922. To unlock the connecting member 906 , the locking clip 920 may be deformed sufficiently to release from the cooperating jaws 922 .

[0188] Figure 10A 、 Figure 10B 、 Figure 10C and Figure 10D An example foldable lead anchor 1000 is shown for securing a lead 206 to a patient to prevent or inhibit movement of the lead 206 at the installation site. The foldable lead anchor 1000 can be used in conjunction with any of the connectors described herein. In the illustrated example, the foldable lead anchor 1000 includes a base 1002 and an arm 1004 flexibly connected to the base 1002. The base 1002 and the arm 1004 together define a lead channel 1006 for receiving the lead 206.

[0189] Base 1002 includes guide tabs 1008 and defines suture holes 1010 configured to receive sutures for attaching foldable lead anchor 1000 to a patient. Lead channel 1006 is configured to receive guide tabs 1008. This aligns suture holes 1014 with at least a portion of suture holes 1010 of base 1002. When installed, lead 206 is inserted into lead channel 1006, arm 1004 is deformed so that guide tabs 1008 are inserted into lead channel 1006, and sutures are deployed in conjunction with suture holes 1010 and 1014.

[0190] Figure 11A and Figure 11BAn example adhesive-based lead anchor 1100 is shown for securing a lead 206 to a patient to prevent or inhibit movement of the lead 206 at the installation site. The adhesive-based lead anchor 1100 can be used in conjunction with any of the connectors described herein. In the example shown, the adhesive-based lead anchor 1100 includes a loop 1102 that is adhered to the lead 206. The loop 1102 includes a flat portion 1104 that is a point of attachment for a bandage 1104 (e.g., Figure 11B ), such as a steri-strip bandage. Loop 1102 can be clipped onto lead 206.

[0191] Figure 12A and Figure 12B An adhesive-based lead anchor 1200 is shown for securing a lead 206 to a patient to prevent or inhibit movement of the lead 206 at the installation site. The adhesive-based lead anchor 1200 may be used in conjunction with any of the connectors described herein. The body 1202 of the lead anchor 1200 is generally planar. The body 1202 defines a lead channel 1204 to receive the lead 206. The lead channel 1204 may be configured to provide a friction fit for the lead 206. To prevent movement of the lead anchor 1200, a surface of the body 1202 is configured to receive a bandage adhered to the body 1202 and the patient, such as Figure 12B shown.

[0192] Figure 13 An example dual-purpose lead anchor 1300 is shown for securing lead 206 to a patient to prevent or inhibit movement of lead 206 at the installation site. Dual-purpose lead anchor 1300 can be used in conjunction with any of the connectors described herein. Dual-purpose lead anchor 1300 has a body 1302 that is generally planar. Body 1302 defines a lead channel 1304 for receiving lead 206. Lead channel 1304 can be configured to provide a friction fit for lead 206. To prevent movement of dual-purpose lead anchor 1300, a surface of body 1302 is configured to receive a bandage adhered to body 1302. Body 1302 also defines suture holes 1306. Suture holes 1306 can be used to suture dual-purpose lead anchor 1300 to the patient. In some examples, dual-purpose lead anchor 1300 can be attached to the patient using only a bandage. In some examples, dual-purpose lead anchor 1300 can be attached to the patient using only sutures. In some examples, the dual-purpose lead anchor 1300 can be attached to the patient using both sutures and a bandage.

[0193] Figure 14An example protective cover 1400 is shown that protects the connector 1402, the connector base 1404, and the leads (not shown) when the leads are installed. In some examples, the protective cover 1400 is a thermoformed plastic cover that is located between the components (e.g., the connector 1402, the connector base 1404, the leads, etc.) and the bandage to prevent the components from lifting when the bandage is changed. In the example shown, the protective cover 1400 includes a body 1406 and legs 1408. The body 1406 includes side walls 1410 and a top wall 1412. The side walls 1410 and the top wall 1412 form a cavity in which the connector 1402, the connector base 1404, and the leads are located when the protective cover 1400 is installed. The legs 1408 are generally planar and extend from the side walls 1410 of the body 1406. In the example shown, the legs 1408 define a cable channel 1414 that provides access from the cavity to accommodate the cable 204 connected to the connector 1402. When installed, the protective cover 1400 can be adhered to the patient via a bandage (such as a TEGADERM bandage) that covers the body 1406, the legs 1408, a portion of the cable 204 extending from the cable channel 1414, and the area of the patient surrounding the protective cover 1400.

[0194] Figure 15A and Figure 15B An example of a protective cover 1500 is shown that protects the connector 1502, connector base 1504, and leads (not shown) when the leads are installed. Protective cover 1500 is a thermoformed plastic cover that is positioned between components (e.g., connector 1502, connector base 1504, leads, etc.) and bandage 1505 to prevent the components from lifting when bandage 1505 is changed. In the example shown, protective cover 1500 includes a body 1506 and legs 1508. Body 1506 includes sidewalls 1510 and a top wall 1512. Sidewalls 1510 and top wall 1512 form a cavity within which connector 1502, connector base 1504, and leads are positioned when protective cover 1500 is installed. Legs 1508 are generally planar and extend from sidewalls 1510 of body 1506. In the example shown, sidewalls 1510 include channel walls 1514 extending therefrom. The channel wall 1514 defines a cable channel 1516 that provides access from the cavity to accommodate the cable 204 connected to the connector 1502. In the example shown, the legs 1508 do not extend from the side walls 1510 at locations corresponding to the cable channel 1514. When installed, the protective cover 1500 can be adhered to the patient via a bandage (such as a TEGADERM bandage) that covers the body 1506, the legs 1508, the portion of the cable 204 extending from the cable channel 1516, and the area of the patient surrounding the protective cover 1500.

[0195] Figure 16AAn exploded view of a protective cover 1600 is shown, which is configured such that a cable 1602 remains outside the protective cover 1600. Figure 16A A specific detachable cable is shown (see below Figure 21A 、 Figure 21B 、 Figure 21C and Figure 21D ), but the protective cover 1600 can be used with any of the detachable cables and corresponding connectors described herein. When the leads are installed, the protective cover 1600 protects the connector 1604, the connector base 1606, and the leads (not shown). The protective cover 1600 is a thermoformed plastic cover that is positioned between the components (e.g., the connector 1604, the connector base 1606, the leads, etc.) and the bandage to prevent the components from lifting when the bandage is changed. In addition, the protective cover 1600 facilitates connecting and disconnecting the cable 1602 without removing the bandage or the protective cover 1600.

[0196] In the illustrated example, protective cover 1600 includes a body 1608 and legs 1610. Body 1608 includes sidewalls 1612 and a top wall 1614. Sidewalls 1612 and top wall 1614 form a cavity within which connector 1604, connector base 1606, and leads are positioned when protective cover 1600 is installed. Legs 1610 are generally planar and extend from sidewalls 1612 of body 1608. In the illustrated example, legs 1610 include tabs to, for example, reduce the amount of material used to form legs 1610.

[0197] The top wall 1614 defines an aperture 1616 and a port aperture 1618. In the example shown, a disc 1620 is placed within the port aperture 1618. The disc 1620 is made of a different material than the body 1608, which resists adhesion by a bandage. The disc 1620 defines a connector aperture 1622 to facilitate connection of the cable 1602 to the connector 1604 through the protective cover 1600. When installed, the protective cover 1600 can be adhered to the patient via a bandage, such as a TEGADERM bandage.

[0198] Figure 16B The protective cover 1624 is configured to retain the cable 1602 outside the protective cover 1624. The protective cover 1624 includes a body 1608 and legs 1610. The body 1608 includes side walls 1612 and a top wall 1626. The side walls 1612 and the top wall 1626 form a cavity in which a connector (e.g., connector 1604), a connector base (e.g., connector base 1606), and leads are located when the protective cover 1624 is installed. The legs 1610 are generally planar and extend from the side walls 1612 of the body 1608. In the example shown, the legs 1610 include tabs to, for example, reduce the amount of material used to form the legs 1610.

[0199] The top wall 1626 includes a point 1628 containing a conductive material. The bottom side of the point 1628 is conductive. The top wall 1626 and the point 1628 are configured so that there is no conductivity on the surface that the user can touch. The only conductive area is on a single axis (i.e., the z-axis directly below the connector head). The top of the point 1628 is non-conductive. This configuration provides greater flexibility for the clinician. Once the lead is inserted, the protective cover 1624 can be easily placed in a variety of positions while still being able to be electrically connected. Any point 1628 can be used to create an electrical connection.

[0200] Figure 17A 、 Figure 17B 、 Figure 17C and Figure 17D A cable 1700 is shown having a magnetic head 1702 (sometimes referred to as a "magnetic release head") and a connector 1704 having a corresponding magnetic bracket 1706. The connector 1704 may be, for example, Figure 6A 、 Figure 6B 、 Figure 6C 、 Figure 6D 、 Figure 6E and Figure 6F 17. An example of a connector 600 is shown in FIG. 17, wherein the cable port 630 includes a magnetic bracket 1706. The magnetic bracket 1706 includes a magnetic ring 1708 that mates with a corresponding magnetic ring 1710 of the magnetic head 1702. The cable 1700 is removably coupled to the connector 1704. When the cable 1700 is attached to the connector 1704, the attractive force of the magnetic rings 1708 and 1710 attaches the cable 1700 to the connector 1704. The magnetic head 1702 includes a conductive pin 1712. When the cable 1700 is attached to the connector 1704, the pin 1712 pierces the bandage 1714 and is inserted into the receptacle 1716 of the magnetic bracket 1706 to electrically couple the cable 1700 to the connector 1704. The magnetic bracket 1706 is electrically coupled to the blade of the connector 1704. Thus, when the cover of the connector 1704 is closed and the magnetic head 1702 is attached to the magnetic bracket 1706 , the cable 1700 is electrically coupled to the leads 206 attached to the connector 1704 .

[0201] Figure 18A and Figure 18B A cable 1700 having a magnetic head 1702 and a Figure 17A 、 Figure 17B 、 Figure 17C and Figure 17D The connector 1704 of the corresponding magnetic bracket 1706, the cable 1700 and the connector 1704 are connected to, for example Figure 16A1704. In the example shown, the pin 1712 of the magnetic head 1702 pierces the bandage 1714 and extends through the connector hole 1622 to be inserted into the receptacle 1716 of the magnetic bracket 1706 to electrically couple the cable 1700 to the connector 1704. In this way, the cable 1700 can be removed and / or switched without disturbing the connector 1704 and the leads 206. In the example shown, for example, to reduce the amount of material used, the protective cover 1600 can have a molded raised portion 1800 to accommodate the connector 1704 and lowered portions 1802 elsewhere.

[0202] Figure 19A 、 Figure 19B and Figure 19C A cable 1700 having a magnetic head 1702 and a Figure 17A 、 Figure 17B 、 Figure 17C and Figure 17D The connector 1704, the cable 1700, and the connector 1704 are used in combination with the protective cover 1900. In the example shown, the protective cover 1900 includes a body 1902 and legs 1904. The body 1902 includes side walls 1906 and a top wall 1908. The side walls 1906 and the top wall 1908 form a cavity in which the connector 1704 and the leads 206 are located when the protective cover 1900 is installed. The connector 1704 can be inserted into a connector base (not shown). The legs 1904 are generally planar and extend from the side walls 1906 of the body 1902. In the example shown, the top wall 1908 includes an opening matrix 1910 through which the pins 1712 of the magnetic head 1702 can extend (e.g., pierce the bandage 1714, etc.) when the cable 1700 is connected to the connector 1704. When the protective cover 1900 is installed, the matrix 1910 is generally positioned above the magnetic bracket 1706. The matrix 1910 can allow for flexible placement of the connector 1704 relative to the protective cover 1704, for example.

[0203] Figure 20A 、 Figure 20B and Figure 20C A detachable cable 2000 having an interlocking head 2002 and a connector 2004 having a corresponding interlocking frame 2006 defining a receptacle 2008 are shown. The detachable cable 2000 and connector 2004 may be used with, for example, Figure 16A The protective cover 1600 is used in conjunction with the interlocking frame 2006 extending through the connector hole 1622. The connector 2004 can be, for example Figure 6A 、 Figure 6B 、 Figure 6C 、 Figure 6D 、 Figure 6E and Figure 6F6, wherein the cable port 630 includes an interlocking bracket 2006. In the example shown, the connector 2004 is modified to be inserted into a wing-shaped connector base 2010.

[0204] In the example shown, the interlock frame 2006 includes an inner frame 2012 and an outer frame 2014 that define a receptacle 2008. In the example shown, the receptacle 2008 includes a frusto-conical portion to facilitate guiding a pin 2016 of the interlock head 2002. The inner frame 2012 and the outer frame 2014 define a guide channel 2016.

[0205] Interlock head 2002 includes a pin 2017 electrically coupled to the conductive leads of detachable cable 2000, an inner guide 2018, and an outer wall 2020. Inner guide 2018 and outer wall 2020 define an interlock channel 2022. Inner guide 2018 is configured to fit within guide channel 2016, and outer frame 2014 is configured to fit within interlock channel 2022. In some examples, interlock head 2002 includes a pin guide 2024 configured to fit within at least a portion of the frustoconical portion of receptacle 2008. When interlock head 2002 is inserted into interlock frame 2006, pin 2016 is electrically coupled to the blades, such that when the cover of connector 2004 is closed and interlock head 2002 is inserted into interlock frame 2006, cable 2000 is electrically coupled to the leads attached to connector 2004.

[0206] In the example shown, connector base 2010 includes a base 2026, a side wall 2028 having wings 2030. Side wall 2028 defines a snap-fit aperture 2032. Connector 2004 includes a locking member 2034 configured to snap fit into snap-fit aperture 2032. Side wall 2028 is deformable enough so that a downward force on wings 2030 horizontally displaces side wall 2028 enough to release locking member 2034 from snap-fit aperture 2032.

[0207] Figure 21A 、 Figure 21B 、 Figure 21C and Figure 21D A cable 2100 having a magnetic head 2102 (sometimes referred to as a "magnetic release head") and a connector 2104 having a pin connector 2106 are shown. Figure 21D As shown, the cable 2100 and connector 2104 can be used with, for example Figure 16A The protective cover 1600 is used in conjunction with the pin connector 2106, wherein the pin connector 2106 extends through the connector hole 1622. The connector 2004 can be, for example Figure 6A 、 Figure 6B 、 Figure 6C 、 Figure 6D 、 Figure 6E and Figure 6FAn example of connector 600 in which the cable port 630 includes a pin connector 2104.

[0208] Pin connector 2106 includes a conductive pin 2108 and a magnetic ring 2110. Conductive pin 2108 is electrically coupled to the blade of connector 2104. Magnetic head 2102 includes a magnetic ring 2112. Magnetic head 2102 further defines a socket 2114 in which a conductive pad 2116 is disposed. Conductive pad 2116 is electrically coupled to the conductors of cable 2100. When cable 2100 is inserted into connector 2104, conductive pin 2108 enters socket 2114 and mechanically and electrically couples with conductive pad 2116. In some examples, conductive pin 2108 can be an EEG-safe DIN connector, and socket 2114 can be a corresponding EEG-safe DIN socket. When cable 2100 is attached to connector 2104, the attractive force of magnetic rings 2110 and 2112 directly or indirectly attaches cable 2100 to connector 2104. When the magnetic head 2102 is inserted into the pin connector 2106 and the cover of the connector 2104 is closed, the cable 2100 is electrically coupled to the leads 206 attached to the connector 2104 .

[0209] Figure 22A and Figure 22B A protective cover 1600 is shown that is configured to interface between a header 2200 of a cable 2202 and a cable port 2204 of a connector 2206. The connector 2206 may be, for example, Figure 6A 、 Figure 6B 、 Figure 6C 、 Figure 6D 、 Figure 6E and Figure 6F 600, wherein the cable port 2204 is the cable port 630. In this example, the cable port 2204 includes a conductive element that electrically couples the wall 2208 of the cable port 2204 to the blade of the connector 2206. In the example shown, the cable 2202 is Figure 21B Example of cable 2100.

[0210] Protective cover 1600 includes a connecting element 2210 that fits within port aperture 1618. Connecting element 2210 includes a conductive pin 2212 and a magnetic ring 2214. Conductive pin 2212 includes a cable side 2216 and a connector side 2218. Cable side 2216 is configured to be inserted into receptacle 2114 and mechanically and electrically coupled to conductive pad 2116. Connector side 2218 is configured to be inserted into cable port 2204 and mechanically and electrically coupled to wall 2208 of cable port 2204. Connecting element 2210 can be snap-fitted to cable port 2204. When cable 2100 is attached to connecting element 2210, the attractive force of magnetic rings 2110 and 2214 directly or indirectly attaches cable 2100 to connecting element 2210. Although in the example shown, the connecting element 2210 has a conductive pin 2212 that includes a cable side 2216 for interfacing with the head 2200 of the cable, the connecting element 2210 may have any other suitable interface, such as with a Figure 17A 、 Figure 17B 、 Figure 17C and Figure 17D The magnetic head 1702 or Figure 20A 、 Figure 20B 、 Figure 20C The interlocking head 2002 cooperates with the interface, etc.

[0211] Figure 23A and Figure 23B A cable 2300 and a connector 2302 are shown with inductive interfaces 2304 and 2306. The connector 2302 may be, for example, Figure 6A 、 Figure 6B 、 Figure 6C 、 Figure 6D 、 Figure 6E and Figure 6F6. An example of a connector 600 is shown, wherein cable port 630 includes an inductive interface 2306. Cable 2300 includes an inductive head 2308. Inductive head 2308 includes an inductive interface 2304 and an alignment and retention magnet 2310. Connector 2302 includes an alignment and retention magnet 2312 that corresponds to alignment and retention magnet 2310 of inductive head 2308. When connected, the magnetic force of alignment and retention magnets 2310 and 2312 attaches inductive head 2308 to connector 2302, even when bandage 2314 is secured to connector 2302 and prevents direct contact between connector 2302 and inductive head 2308. Inductive interface 2306 of inductive head 2304 and inductive interface 2306 of connector 2302 have corresponding inductive coils that are aligned with each other via alignment and retention magnets 2308 and 2310. The inductive interface 2306 of the inductive head 2304 sends a signal to the inductive interface 2306 of the connector 2302. In this case, the cable 2300 can send stimulation signals to the lead 206 via the connector 2302 even though the bandage 2314 prevents direct contact between the cable 2300 and the connector 2302.

[0212] Figure 24 An example thin connector 2400 is shown containing a cable 2402. The thin connector 2400 snaps into a thin connector base 2404. In the example shown, the thin connector base 2404 is connected to the base via Figure 1 The adhesive pad 100 is attached to the patient. The thin connector 2400 includes a first arm 2406 and a second arm 2408. The first arm 2406 and the second arm 2408 are flexibly coupled to allow the first arm 2406 and the second arm 2408 to be opened and closed to each other. The first arm 2406 and the second arm 2408 each include a ridge that defines a lead channel 2410 and 2412, respectively. One of the lead channels 2410 and 2412 includes a microblade (not shown) that passes through the insulating layer that covers the conductive element of the lead 206 when the thin connector 2400 is closed and is electrically coupled to the conductive element of the cable 2402. The microblade is then electrically coupled to the conductive element of the cable 2402. In the example shown, the cable 2402 is flat to be flush with the patient's body. The conductive element of the cable 2402 can be a flexible ribbon wire.

[0213] The thin connector base 2404 includes a base 2414 and a plurality of snap forks 2416. The snap forks 2416 are configured to secure the thin connector 2400 to the base 2414 of the thin connector base 2404 and to hold the first arm 2406 and the second arm 2408 in a closed position. The thin connector 2400 can then be further secured to the patient and the thin connector base 2404 via a bandage. The low profile of the thin connector 2400 and the thin connector base 2404 can prevent displacement due to collisions with the patient.

[0214] Figure 25 An example polarized connector 2500 and a polarized connector base 2502 are shown. In the example shown, the polarized connector base 2502 is connected to the polarized connector base 2502 via Figure 1 The adhesive pad 100 is attached to the patient. The polarized connector 2500 includes a body 2504, a cover 2506 rotatably connected to the body 2504, a first set of magnets having a first polarization, and a second set of magnets having an opposite polarization. In the illustrated example, a cable 2508 is integrated into the polarized connector 2500. The body 2504 defines a lead channel 2510 for receiving a lead and a cover channel 2512 for receiving the cover 2506 when the cover 2506 is in a closed position. The cover 2506 can be snap-fit or friction-fit into the cover channel 2512. The cover 2506 includes a blade electrically coupled to the cable 2508. When the cover 2506 is in the closed position, the blade electrically couples to the lead to electrically couple the lead to the cable 2508.

[0215] Polarized connector base 2502 includes a first set of magnets 2514 having a first polarization and a second set of magnets 2516 having an opposite polarization. The magnets of polarized connector 2500 and magnets 2514 and 2516 of polarized connector base 2502 are arranged so that polarized connector 2500 connects to polarized connector base 2502 in a specific orientation. Polarized connector 2500 resists being pulled away from polarized connector base 2502 using a force perpendicular to polarized connector base 2502, but can be rotated about a normal axis to misalign the magnets to release polarized connector 2500.

[0216] Figure 26A 、 Figure 26B and Figure 26C An example of a protective cover 2600 with an integrated cable header 2602 is shown. Protective cover 2600 interfaces with a detachable cable 2604. Protective cover 2600 is configured to selectively interface with connector 2606. Connector 2606 can be any connector described herein. Additionally, the interface between integrated cable header 2602 and connector 2606 can be any interface described herein. In the example shown, connector 2606 can be selectively attached to a connector base 2608.

[0217] In the illustrated example, the body 2610 of the integrated cable head 2602 is integrally formed with the body 2612 of the protective cover 2600. The body 2610 of the integrated cable head 2602 includes an interface portion 2614 that houses an interface 2616, which selectively connects to a corresponding interface 2618 of the connector 2606. The body 2610 of the integrated cable head 2602 also includes an interconnection portion 2620 that houses a plug 2622 that selectively receives a corresponding receptacle 2624 of the detachable cable 2604. The plug 2622 is electrically coupled to the interface 2616. When the receptacle 2624 of the detachable cable 2604 is electrically and mechanically coupled to the plug 2622, the conductive elements of the detachable cable 2604 are electrically coupled to the interface 2616.

[0218] Figure 27A 、 Figure 27B 、 Figure 27C 、 Figure 27D 、 Figure 27E 、 Figure 27F 、 Figure 27G and Figure 27H An example stimulation lead connection system 2700 is shown. In the example shown, the lead connection system 2700 includes a protective cover 2702, a connector 2704, and a connector base 2706. In some examples, the lead connection system 2700 can also include a lead anchor (such as any of the lead anchors described herein). Figure 27B A connector 2704 is shown selectively attached to a connector base 2706. The connector 2704 is attached to the connector base 2706 by vertical motion (e.g., motion perpendicular to the plane defined by the connector base 2706). In the example shown, the connector 2704 includes wings 2708 that define slots 2710 to receive corresponding latches 2712 of the connector base 2706. Figure 27C As best shown in FIG. 2 , the connector base 2706 includes latches 2712 that facilitate attaching the connector 2704 in different orientations such that when the connector 2704 is secured, it may not be coupled to each latch 2712 .

[0219] In the example shown, the connector base 2706 includes a base 2714 and a bracket 2716. In the example shown, the bracket 2716 is integrally formed with the base 2714. The base 2714 defines suture holes 2718 to facilitate suturing the connector base 2706. Alternatively, the connector base 2706 can be attached to the base 2714 via an adhesive pad (e.g., Figure 1The bracket 2716 includes a latch 2712. The latch 2712 includes a catch edge 2720 that engages the slot 2710 of the connector 2704. When the connector 2704 is pressed into the connector base 2706, the ramp portion 2724 of the latch 2712 promotes deformation of the wing 2708, thereby facilitating the snap-fitting of the connector 2704 into the connector base 2706.

[0220] Connector 2704 includes wings 2708 connected to connector 2704 via attachment members 2722. Attachment members 2722 are sufficiently deformable such that an inward force on wings 2708 is sufficient to displace the position of slot 2710 to release it from capturing edge 2720 of latch 2712. In the example shown, wings 2708 include ramped edges 2726 that are configured to mate with ramp portion 2724 of latch 2712.

[0221] In the illustrated example, connector 2704 includes a base 2728 and a cover 2730. Base 2728 and cover 2730 are rotatably connected via a hinge or axis 2732. In the illustrated example, base 2728 and cover 2730 are rotatably connected along a longer side so that when lead 206 is inserted into connector 2704, the axis of rotation is substantially parallel to lead 206. Base 2728 includes a plurality of sidewalls 2734 and a bottom plate 2836. When cover 2730 is in place, an internal cavity 2738 is formed. Lead 206 is received in cavity 2738 through port 2740.

[0222] 2748 .

[0223] The cover 2730 has a generally flat, planar shape. The cover 2730 includes a cable port 630. The cable port 2748 can include any of the cable interfaces described herein, such as the magnetic bracket 1706, the interlocking bracket 2006, or the pin connector 2106. The cover 2730 integrally forms locking clips 2750 to facilitate securing the cover 2730 to the base 2728. Each locking clip 2750 includes a snap-fit edge at a distal end of a ramp. The snap-fit edge snaps into place on a slot defined by the base 2728, while the ramp provides a resting position on the slot to provide, for example, a closed but unlocked configuration.

[0224] Figure 28A and Figure 28B Different configurations of an example stimulation lead connection system 2800 are shown. In the example shown, the stimulation lead connection system 2800 includes a detachable cable 2802 having a breakaway portion 2804, a push-lock connector 2806, a connector base 2808, and a bandage 2810. In operation, the breakaway portion 2804 of the detachable cable 2802 is coupled to (e.g., via a magnetic connector, etc.) a corresponding breakaway portion 2811 of a generator cable 2812. Although the detachable cable 2802 is shown as being inserted into the push-lock connector 2806, the push-lock connector 2806 and the detachable cable 2802 can utilize any connection interface described herein (e.g., the magnetic head 1702).

[0225] In the example shown, the detachable cable 2802 includes a coiled portion 2813. The coiled portion 2813 acts like a shock absorber. If tension is applied to the push-lock connector 2806, the coiled portion 2813 prevents or inhibits the lead 206 from being pulled out of the patient. In addition, the adhesive force between the connector base 2808 and the skin is selected to be greater than the magnetic force between the detachable cable 2802 and the push-lock connector 2806. In this way, the detachable cable 2802 and the push-lock connector 2806 will separate when a force is applied to the pulse generator 2814, and the connector base 2808 or the lead 206 will be prevented or inhibited from being pulled loose from the patient. In some examples, the system 2800 is configured such that the order of force required to separate the two components is as follows (from highest to lowest): 1) the connector base 2808 to the patient's skin, 2) the push-lock connector 2806 and the connector base 2808 (e.g., via a magnetic, snap-fit, and / or friction fit), and 3) the connection between the detachable cable 2802 and the push-lock connector 2806. However, the final connection is selected to be sufficiently secure that it will not disconnect during normal activity. In some examples, the detachable cable 2802 includes a connector head 2815 that is configured to electrically and mechanically couple the detachable cable 2802 to the push-lock connector 2806. The magnetic connector head 2815 (sometimes referred to as a "magnetic breakaway head") couples the detachable cable 2802 to the push-lock connector 2806 such that the force on the detachable cable 2802 will cause the detachable cable 2802 to disconnect from the push-lock connector 2806 before the adhesive securing the connector base 2808 to the patient's skin breaks away from the patient's skin. The magnetic connector head 2815 can be, for example, any of the magnetic connectors described herein (e.g., magnetic head 1702, magnetic head 2102, etc.). Alternatively, in some examples, the connector head 2815 can provide a mechanical connection with a friction fit such that a force on the detachable cable 2802 causes the detachable cable 2802 to disconnect from the push-to-lock connector 2806 (e.g., connector head 2002, etc.) before the adhesive securing the connector base 2808 to the patient's skin is released from the patient's skin.

[0226] Generator cable 2812 is a connector for pulse generator 2814, which generates stimulation signals for use in, for example, stimulation therapy. Pulse generator 2814 is attached to mounting pad 2816, which in turn is adhered to the patient. In operation, connector base 2808 is attached to adhesive pad 2818. Adhesive pad 2818 may be above Figure 1100. The distal end of the lead 206 is implanted in the patient and / or otherwise therapeutically attached to the patient. The proximal end of the lead 206 is mechanically and electrically coupled to the push-lock connector 2806. In this configuration, the distal end of the lead 206 is electrically coupled to the pulse generator 2814. In the example shown (e.g., below Figure 29D ), lead 206 includes a coiled portion 2819. Coiled portion 2819 acts like a shock absorber. If tension is present on push-to-lock connector 2806 and / or lead 206, coiled portion 2819 prevents or blocks lead 206 from being pulled out of the patient.

[0227] The physician may use the push-lock connector 2806 to facilitate connecting the lead 206 to a cable from the pulse generator 2814 (e.g., the detachable cable 2802 and the generator cable 2812, etc.). The connector base 2808 has a rigid top and provides a snap-in location for the push-lock connector 2806. The connector base 2808 includes an adhesive pad 2818 that can be adhered to the patient's skin. Connecting the connector 2806 to the connector base 2808 (which can be adhered to the skin) is meant to secure the connector 2806 in place during typical use. The cable connects the push-lock connector 2806 to the pulse generator 2814 (e.g., PNS system, etc.). Bandage 2810 can be a waterproof IV dressing. Bandage 2810 provides a protective waterproof barrier over the exit site of lead 206. The adhesive portion 2820 of bandage 2810 is placed over the straight portion of detachable cable 2802, allowing stimulation signals to propagate under this waterproof barrier without compromising the seal itself. Bandage 2810 has a clear non-adhesive window 2822 in the middle to allow the patient / caregiver / physician to view / inspect the exit site of lead 206 without removing bandage 2810. This allows for fewer bandage changes to be required throughout the treatment process. Figure 28A In the illustrated example of , the coiled portion 2813 is at least partially covered by the adhesive portion 2820 of the bandage 2810. Alternatively, as Figure 28B As shown, the coiled portion 2813 can be completely contained within the transparent non-adhesive window 2822.

[0228] Figure 29A 、 Figure 29B 、 Figure 29C 、 Figure 29D 、 Figure 29E 、 Figure 29F 、 Figure 29G 、 Figure 29H 、 Figure 29I 、 Figure 29J 、 Figure 29K and Figure 29LAn example push lock connector 2806 and connector base 2808 are shown in FIG28. The push lock connector 2806 has an open position and a closed position. An example of a push lock connector 2806 in the open position is shown in FIG28. Figure 29E 、 Figure 29F (Partially open), Figure 29H 、 Figure 29J and Figure 29K An example of a push-lock connector 2806 in a closed position is shown in FIG. Figure 29A 、 Figure 29B 、 Figure 29C 、 Figure 29D 、 Figure 29G 、 Figure 29I and Figure 29L As shown in Figure 29A 、 Figure 29B 、 Figure 29C and Figure 29D As shown, the push-to-lock connector 2806 is configured to snap fit into the connector base 2808 . Figure 29J 、 Figure 29K and Figure 29L is a cross-sectional view of the push-lock connector 2806 (from Figure 29H AA line shown in FIG).

[0229] The push-lock connector 2806 includes an insert 2900 and a body 2902. Figure 7A 、 Figure 7B 、 Figure 7C and Figure 7D Similar to the push-lock connector 700 of the present invention, inserting the insert 2900 into the body 2902 with the lead in the push-lock connector 2806 will lock the lead in the push-lock connector 2806 and, in some examples, engage the one or more blades with the lead 206. This can be done by the clinician with one hand. Since a separate key is not used to lock and unlock the bodies 2900 and 2902 relative to each other, a single hand can be used. Figure 30A 、 Figure 30B 、 Figure 30C An example of an insert 2900 is shown in FIG. An example of a body 2902 is shown in FIG. Figure 31 As shown in Figure 32A and Figure 32B As shown, when the insert 2900 is pushed into the body 2902, the leads 206 are moved from the open position ( Figure 32A ) is pushed into the closed position ( Figure 32B ), the leads are mechanically and electrically coupled to the push-lock connector 2806.

[0230] Insert 2900 includes a chassis 2904, a handle 2906, an insertion guide 2908, a forward latch 2910, and a rear latch 2912. Chassis 2904 defines a wire channel 2914 and one or more blade channels 2916 perpendicular to wire channel 2914. Wire channel 2914 receives wire 206. In the illustrated example, wire channel 2914 includes cooperating ledges 2918A and 2918B that help secure wire 206, for example, when push-to-lock connector 2802 is in a closed position. For example, when the blades contact the wire when push-to-lock connector 2806 is closed, the cooperating ledges 2918A and 2918B can prevent movement of the wire perpendicular to wire channel 2914. Blade channel 2916 is configured to facilitate sliding of a blade (eg, lower blade 2926) therethrough as push-to-lock connector 2802 is opened and closed.

[0231] The handle 2906 includes a semi-rigid connecting member 2920 that deforms when the push-to-lock connector 2806 is inserted into the connector base 2908. This provides a friction fit with the connector base 2908, such that the force of the connecting member 2920 pushing against the deformation selectively locks the push-to-lock connector 2806 into the connector base 2908. To release the push-to-lock connector 2806, a force can be applied to the handle member 2922 of the handle 2906 to deform the connecting member 2920 sufficiently to release the push-to-lock connector 2806 from the connector base 2908. The insertion guide 2908 resides in the body 2902 in both the open and closed positions to provide a stable connection between the insert 2900 and the body 2902, for example. The front latch 2910 and the rear latch 2912 limit the movement of the insert 2900 and selectively lock the push-to-lock connector 2806 in open and closed positions, respectively, when operating with the body 2902 (described below).

[0232] The body 2902 includes a chassis 2924, one or more blades 2926, a front latch 2928, and a rear latch 2930. In the example shown, the chassis 2924 includes a blade mounting member 2932 that is configured to slidably receive the blade 2926. The chassis 2924 defines a port 2934 through which a lead can pass when the lead is in the lead channel 2914. The port 2934 can be generally a U-shaped hole in the chassis 2924.

[0233] In the illustrated example, blades 2926 are made of a conductive material. In the illustrated example, body 2902 includes two blades 2926. However, in other examples, body 2902 may include more or fewer blades 2924, for example, one, three, four, five, six, etc. Blades 2926 are electrically coupled directly or indirectly to a connector port that receives detachable cable 2802 (as shown, for example, in Figures 28 and 29B). Blade 2926 is generally a U-shaped bracket having a top 2936 and two sides 2938. Top 2936 engages one of blade mounting members 2932 and connects two sides 2938. Each side 2938 defines a leading edge 2940 that engages a lead when push-to-lock connector 2806 is closed. Leading edge 2940 can be configured (e.g., sharpened, etc.) to displace insulation from a portion of the lead to expose the underlying conductor or conductive wire, strand, filament, and / or cable. For example, the angled leading edge 2940 can include a cutting edge to strip or cut the lead when the insert 2900 is pushed into the body 2902 to the closed position. In this way, when the push-to-lock connector 2806 is closed, the blade 2926 is electrically coupled to the underlying conductive wire of the lead.

[0234] like Figure 29H and Figure 29I As best shown, the front latch 2928 and the rear latch 2930 of the body 2902 cooperate with the front latch 2910 and the rear latch 2912 of the insert 2900 to define the open position and the closed position of the push-to-lock connector 2806. Figure 29H ), the rear latch 2930 of the body 2902 snaps between the chassis 2904 of the insert 2900 and the rear latch 2912 of the insert 2900. This prevents the insert 2900 from being completely removed from the body 2902 and selectively locks the push-to-lock connector 2806 in the open position. In the closed position (e.g., as Figure 29I 29), the front latch 2928 of the body 2902 engages the front latch 2910 of the insert 2900. This selectively locks the push-to-lock connector 2806 in the closed position and prevents the push-to-lock connector 2806 from transitioning to the open position without the application of force to the insert 2900 (e.g., via the handle 2906, etc.).

[0235] like Figure 29C and Figure 29DAs best shown, push-lock connector 2806 includes a set of ridges 2942 on the top surface of push-lock connector 2806 and a set of grooves 2944 on the bottom surface of push-lock connector 2806. The top ridges 2942 are used to help enhance one-handed engagement. The bottom grooves 2944 facilitate grasping push-lock connector 2806 with one hand, or even with as little force as two fingers (e.g., index finger and thumb). During a procedure, a clinician may wear gloves and / or have their hands or gloves covered or coated with some medical gel (e.g., a lubricating fluid, gel, or material such as ultrasound gel), which can make their hands and the device slippery and reduce the amount of force that can be applied to the connector, so the clinician can have less force on his / her hand. This can make grasping the device difficult, which is why the ridges 2942 and grooves 2944 are present to aid in grasping.

[0236] The connector base 2808 is configured to selectively receive the push-lock connector 2806. The connector base 2808 includes posts 2824 that cooperate with the handle 2906 to snap-fit and / or friction-fit the push-lock connector 2806 into the connector base 2808. When the push-lock connector 2806 is located in the connector base 2808, one or more posts 2824 can define a cable channel to facilitate connecting and / or disconnecting the detachable cable 2802 from the push-lock connector 2806. In some examples, the connector base 2808 and / or the push-lock connector 2806 can include a locking mechanism to prevent the user / patient from opening the push-lock connector 2806 (e.g., moving the insert 2900 relative to 2902 into an open position, etc.). The locking mechanism can be of any configuration. In some examples, the locking mechanism is a tamper-resistant set screw. However, it should be understood that any type of locking device can be used.

[0237] Figure 32A 、 Figure 32B 、 Figure 32C 、 Figure 32D 、 Figure 32E 、 Figure 32F and Figure 32G is a conceptual diagram of the interaction of the blade 2926 of the insert 2900 with the lead 206 according to the teachings of the present disclosure. Figure 32A and Figure 32B In the illustrated example of , the blade 2926 captures the lead 206 within the blade channel 2916 such that the lead 206 is secured within the push-to-lock connector 2806 . Figure 32C 、 Figure 32D and Figure 32E A blade 2926 having one or more cutting edges 3300 is shown that displaces (e.g., cuts through) an insulating layer 3302 to displace a connection to form a connection with a conductive lead 3304 of the lead 206. Figure 32D and Figure 32FAs shown, when the insert 2900 is pushed into the body 2902, the cutting edge 3300 of the blade 2926 displaces (e.g., pierces) the insulating layer 3302 because the lead 206 is captured between the blade 2926 and the body 2904 of the insert 2900. Figure 32E and Figure 32G In the illustrated example of , the cutting edge 3300 is pushed into contact with the conductive lead 3304, electrically coupling the blade 2926 to the lead 206. In this manner, the push-to-lock connector 2806 is electrically coupled to the lead 206.

[0238] Figure 33 An example stimulation lead connection system 3300 is shown. In the example shown, the stimulation lead connection system 3300 includes a detachable cable 2802 having a breakaway portion 2804, a clamshell connector 3302, a connector base 2808, and a bandage 2810. Although Figure 33 28 . Although not shown, the lead connection system 3300 can be connected to the pulse generator 2814 in operation, as shown in FIG28 . Although the detachable cable 2802 is shown as being inserted into the clamshell connector 3302, the clamshell connector 3302 and the detachable cable 2802 can utilize any connection interface described herein. In addition, the lead connection system 3300 can include any lead anchor described herein. In some examples, the push-lock connector 2806 and the clamshell connector 3302 are functionally interchangeable. The clamshell connector 3302 has an open position and a closed position. An example of the clamshell connector 3302 in the open position is shown in FIG28 . Figure 34D (Partially open), Figure 34F 、 Figure 34G 、 Figure 34H and Figure 34I An example of a clamshell connector 3302 in a closed position is shown in FIG. Figure 34A 、 Figure 34B 、 Figure 34C 、 Figure 34F and Figure 34J As shown in Figure 33 As shown, the clamshell connector 3302 is configured to snap fit into the connector base 2808.

[0239] The clamshell connector 3302 includes a cover 3204, a base 3406, and a handle 2906. The cover 3204 has a generally flat, planar shape. A locking clip 3408 is integrally formed on the cover 3204 to facilitate securing the cover 3204 to the base 3406. The cover 3204 includes blade guides 3410, port guides 3412, and hinge supports 3414. A blade channel 3416 is defined between the blade guides 3410 to accommodate a blade (e.g., lower blade 3420). When the clamshell connector 3302 is closed, the port guides 3412 engage the base 3406 to secure the leads to the clamshell connector 3302. The ends of the port guides 3412 are configured to at least partially enclose the leads when the clamshell connector 3302 is closed. The cover 3204 is rotatably connected to the base 3406 via a hinge or shaft formed between the hinge supports 3414. In the example shown, the base 3406 and the cover 3404 are rotatably connected along one side so that when the leads are inserted into the clamshell connector 3302, the axis of rotation is substantially parallel to the leads.

[0240] The base 3406 includes hinge supports 3416, claws 3418, and blades 3420. The base 3406 also defines lead ports 3422 that are configured to receive leads and, when the clamshell connector 3302 is closed, the port guides 3412 of the cover 3402. The lead ports 3422 are generally U-shaped apertures that cooperate with the port guides 3412 to secure the leads in the clamshell connector 3302. The hinge supports 3416 receive the hinge or axis formed between the hinge supports 3414 of the cover 3404. The claws 3418 are configured to snap-lock with the locking clip 3408 to selectively lock the clamshell connector 3302 in the closed position.

[0241] The blades 3420 are made of a conductive material. In the illustrated example, the body 2902 includes a single blade 3420 formed into a pattern to be received in the blade channel 3416 when the clamshell connector 3302 is closed. However, in other examples, the body 2902 may include more blades 3420. The blades 3420 are positioned between the lead ports 3422 so that when the clamshell connector 3302 is closed, the leads are secured between the blades 3420 and the blade guides 3410, which are between the lead ports 3422. The blades 2926 are electrically coupled, directly or indirectly, to a connector port (such as, for example, a connector) that receives the detachable cable 2802. Figure 33). Blade 3420 defines a leading edge 3422 that abuts against a lead when clamshell connector 3302 is closed. Leading edge 3422 can be configured (e.g., sharpened, etc.) to displace insulation from a portion of the lead to expose the underlying conductor or conductive wire, strand, filament, and / or cable. In this manner, blade 3420 is electrically coupled to the underlying conductive wire of the lead when clamshell connector 3302 is closed.

[0242] The connector can be held in place to avoid unintentional pulling and / or dragging of the leads due to movement or displacement of the connector by a device or structure (such as a bracket and / or support) under a dressing or during bandage changes, while enabling the connector to be moved and / or adjusted as needed and the bracket and / or support to be replaced and / or adjusted as needed. The bracket and / or support can hold the connector in place via plastic molding, adhesives, snaps, stitching and / or other means or mechanisms, including pre-specified and designed mechanical forces such as pressure or press fit, friction fit and / or interference fit, to enable an optimal balance between intentionally easy separation and / or mating of parts and intentionally resistive or difficult separation and / or mating by using pre-specified materials, structures, geometric dimensions and / or tolerances. In an example embodiment, the plastic molding of the bracket can include one or more edges and / or lips that secure the connector to the bracket by, but not limited to, sliding the connector under the edges and / or lips in a lateral (e.g., side to side) and / or rotational (e.g., rotational) direction. As a non-limiting example, the plastic molding of the bracket can include one or more edges and / or lips so that the connector is secured in place when pressed into the bracket and / or slid onto the bracket. The connector can be released by pressing and / or pulling the lip of the bracket to temporarily and / or reversibly deform the material but not permanently and release the connector from the bracket. In another non-limiting example, the connector can be snapped onto the bracket, and / or can be adhered using an adhesive and / or Velcro-like (e.g., hook and loop) material, and / or can be sewn into place. In another non-limiting example, the bracket can hold the connector in a desired position (e.g., not being able to move freely under the bandage by a spring that can be released (enabling the connector to separate from the bracket) by pressing and / or sliding a finger and / or thumb).

[0243] The present invention is intended to enable challenges of use to be overcome, and non-limiting examples include the goal of properly closing a connector on a lead, which is important because the connector may need to be able to be closed using or manipulated with a single hand and ideally two fingers (e.g., index finger and thumb), coupled with the importance of the limitation that due to the need to use friction to close the device, a user may only be able to apply a limited amount of force, which may be significantly limited because the user (e.g., clinician) may wear gloves and / or have their hands or gloves covered or coated with a lubricating fluid, gel, or material (such as ultrasound gel) that causes their hands and the device to slip and reduce the amount of force that can be applied to the connector (e.g., reducing the available friction that can be used to close the device), thereby limiting the amount of force that can be used to close the connector and disrupt the insulating coating (e.g., by the blades and / or teeth), and enabling the remaining applicable portions of the connector to interact with and properly mechanically and / or electrically connect with the conductor or conductive wire, strand, filament, and / or cable of the lead. In an example embodiment, the connector may include a drawer and / or tray, slot and / or sliding mechanism into which one or more leads may be placed and which may be closed or squeezed closed with two fingers (e.g., an index finger and thumb) and / or slid or slide without too much resistance so as not to slip out of the user's fingers when pressure is applied, but with enough resistance to keep the lead open while it is placed into the drawer and / or tray. In another example embodiment, the connector may include a hinged compartment into which one or more leads may be placed, positioned, placed and / or fed, which may be closed using two fingers (e.g., an index finger and thumb). In a non-limiting example, the drawer and / or hinge may include a molded lip (e.g., a buckle) that is strong enough to keep it closed during use of the system, but may not be so strong that it cannot be opened with one hand. In another non-limiting example, the drawer and / or hinge can include a spring-loaded locking mechanism such that when pressure is applied (e.g., a two-finger squeeze), it releases and / or opens to place and / or remove the lead, with enough pressure being applied so that the drawer and / or hinge cannot open freely during use of the system, but not so much pressure that the drawer and / or hinge cannot be opened during an implantation procedure using a single gloved hand that may be soiled (e.g., with ultrasound gel).

[0244] Cables referred to herein as connectors, connections, lead connectors and / or microlead connectors can enable mechanical and / or electrical connections between leads and other cables and / or between leads and an external pulse generator, such connections being made by biting, scraping through, squeezing and / or deforming the insulation of the lead to enable conductive material to come into contact with the conductor or conductive wires, strands, filaments and / or cables of the lead (which may otherwise be coated with insulating material) while avoiding damaging, deforming and / or breaking the lead, conductor or conductive wire, strand, filament and / or cable. The connector can maintain this mechanical and / or electrical connection during patient movement (e.g., bending, walking, exercising, sleeping), during bandage changes (e.g., securing the connector in place, cleaning the site, removing and / or replacing the protective cover, removing and / or replacing the waterproof bandage), and / or during lead testing (e.g., during initial lead placement in the operating room, after the lead is deployed to its final position, in a recovery room after lead placement surgery, assessing lead integrity in the clinic, and / or at home), while also enabling easy removal and replacement and / or replacement at locations along the length of the lead, and while also maintaining the integrity of the lead (e.g., without breaking, damaging, or deforming the conductor or conductive wire, strand, filament, and / or cable of the lead). In one example embodiment, the connection can be made by conductive (e.g., metal) teeth that are small enough to bite and / or scrape through the insulation coating when pressed and / or slid against the lead by closure of the lead connector, but not so tight as to damage the lead conductor or the conductive wire, strand, filament, and / or cable. In another example embodiment, the connection can be made by conductive sandpaper that is coarse enough to break through the insulation coating when slid against and / or rubbed against the lead, but fine enough to avoid damaging the lead conductor or the conductive wire, strand, filament, and / or cable. In another example embodiment, the connection can be made by the blade when the lead is slid, pressed, rolled between, and / or pressed against the blade. In another example embodiment, the lead can be pressed and / or deformed by a sharp piston so that the corners and / or blades break through the insulation coating and make contact with the conductor or the conductive wire, strand, filament, and / or cable of the lead and hold the lead in place throughout the treatment while avoiding damaging, breaking, and / or otherwise deforming the lead. The described connection can function, but is not limited to, when the hinge of the connector is closed, the drawer and / or tray, slot, and / or sliding mechanism drawer of the connector are slid and / or pressed closed, pressure is applied to the connector (e.g., by squeezing), and / or the connector is twisted. The described connections may be located anywhere within the connector to serve the purpose of establishing a mechanical and / or electrical connection between the leads and the cable, and / or between the leads and the external pulse generator.

[0245] The thin-wire coiled lead can include a mechanism to anchor it in place as it exits the skin to withstand breakage, displacement, migration, and / or permanent deformation throughout the treatment or procedure, while also enabling lead lengths of varying lengths to be implanted subcutaneously (e.g., shallow anatomy may only allow insertion of a smaller (e.g., 4 cm) lead length, and / or deeper anatomy may require insertion of a larger (e.g., 10 cm) lead length), and / or while maintaining the flexibility of the percutaneous coiled lead to limit subcutaneous forces (e.g., shear, compression, bending, and / or tension), and / or while limiting the risk of infection (e.g., by enabling, facilitating, encouraging The invention provides a method for removing the lead from the skin barrier and / or preventing the growth of tissue into the helical lead, maintaining a small lead diameter at the exit site (e.g., <0.5 mm, <0.6 mm, <0.7 mm, <0.8 mm, <0.9 mm, <1.0 mm, <2 mm, and / or <3 mm), limiting the piston, unwanted or undesirable movement and / or periodic or repetitive motion of the lead across the skin barrier (e.g., back and forth motion, which may introduce bacteria and / or irritants subcutaneously), and / or simultaneously enabling easy removal at the end of the treatment period in a potentially non-surgical setting (in the non-limiting example of not requiring the use of a scalpel, blade, and / or dissection). In an example embodiment, the lead can be coiled and / or deformed at the lead exit site, and / or the lead can be sutured and / or tunneled into the skin. In another example embodiment, the lead can be coated in a material and / or texture that grasps (e.g., adheres) to the patient's skin. In another example embodiment, the lead can be coupled with a barbed (e.g., toothed, anchoring) material that adheres to the skin and can include a single tooth or can include multiple teeth. The material coupled to or coating the lead can be absorbed by the tissue, and / or can be attached to the lead so that it can be removed when the lead is removed, and / or can include a tab-like portion exposed at the exit site to enable removal (e.g., by grasping and pulling with forceps). In another example embodiment, the lead can be secured at the exit site by a suture pad made of a non-irritating (e.g., fabric and / or gel-like) material that can be secured to the lead (e.g., by folding around the lead, and / or placing over the wire, and / or threading the lead through) and then sutured to the skin with absorbable and / or non-absorbable sutures to secure the lead in place.

[0246] In an example embodiment, the lead connector can be locked into the mounting bracket so that it remains in place during normal patient movement, bandage changes, and / or system connection / disconnection, but can be removed by a single gloved hand (e.g., soiled with ultrasound gel), by a patient or caregiver in a non-clinical setting, and / or by a technician or other caregiver in a clinical setting who may or may not have been previously educated on removing the connector from the mounting bracket. In a non-limiting example, the connector can be vertically lockable so that a two-finger (e.g., thumb and index finger) squeeze can release the connector from the mounting bracket (e.g., by squeezing a molded tab to temporarily deform the connector and release it from the bracket).

[0247] Although embodiments of the present disclosure have been shown in the accompanying drawings and described in the foregoing detailed description, it should be understood that the present disclosure is not limited to the embodiments described alone, but rather that the embodiments described herein are capable of various rearrangements, modifications, and substitutions without departing from the scope of the claims below. Of course, for the purposes of describing this specification, it is not possible to describe every conceivable combination of components or methods, but one of ordinary skill in the art will recognize that many further combinations and permutations of this specification are possible. Each of the above components can be combined or added together in any arrangement to define an introduction device and / or introduction system. Therefore, this specification is intended to cover all such changes, modifications, and variations that fall within the spirit and scope of the appended claims. In addition, to the extent that the term "including" is used in the detailed description or in the claims, the term is intended to be inclusive in a manner similar to the term "comprising" in that "comprising" is interpreted when used as a transitional word in the claims. The following claims are intended to include all modifications and variations as long as they fall within the scope of the claims or their equivalents.

Claims

1. A lead connector for an electrical stimulator system, the connector comprising: a body including a cable interface, said body defining a lead port; a blade attached to the body, the blade having at least one angled portion; and an insert slidably connected to the body, the insert comprising a handle and a chassis, the chassis defining a lead passage coaxial with the lead port, and a blade passage transverse to the lead passage to receive the blade, wherein the angled portion of the blade provides electrical contact between the cable interface and a lead inserted into the lead channel and extending through at least one of the lead ports, Wherein, the blade includes two side members, each side member having one of the angled portions, each of the two side members being configured to slide into a different one of the blade channels.

2. The lead connector according to claim 1, wherein The lead connector has an open position and a closed position, and wherein slidably transitioning from the open position to the closed position causes the blade to secure a portion of the lead inserted into the lead channel into the blade channel.

3. The lead connector according to claim 1, wherein The angled portion of the blade includes a cutting edge to strip or sever the leads when the insert is pushed into the body to a closed position.

4. The lead connector according to claim 1, wherein The handle provides a snap fit to selectively couple the lead connector into a connector base.

5. The lead connector according to claim 1, wherein The lead connector has an open position and a closed position, wherein: The insert includes a first set of front latches and a first set of rear latches; and The body includes a second set of front latches for cooperating with the first set of front latches to selectively lock the lead connector in the open position, and a second set of rear latches for cooperating with the first set of rear latches to selectively lock the lead connector in the closed position.

6. The lead connector according to claim 1, wherein The cable interface is a magnetic bracket defining a receptacle to receive a conductive pin of a cable, the receptacle being surrounded by a ring magnet to magnetically attach the cable to the cable interface.

7. The lead connector according to claim 1, wherein The cable interface includes a ring magnet for magnetically attaching a cable to the cable interface and a conductive pin for inserting into a corresponding receptacle of the cable.

8. A lead connector for an electrical stimulator system, the connector comprising: a base including a cable interface, said base defining a lead port; a blade attached to the body, the blade having at least two sections transverse to an axis defined by the lead port; and a cover rotatably connected to the base, the cover including a handle, a blade guide, and a lead guide, the blade guide defining blade channels, each blade channel interfacing with a different one of the sections of the blade, wherein a portion of each section of the blade provides electrical contact between the cable interface and a lead inserted into at least one of the lead ports, Wherein, the blade includes two side members, each side member having one of the sections of the section, each of the two side members being configured to slide into a different one of the blade channels.

9. The lead connector according to claim 8, wherein The cover is configured to rotate about a first axis that is parallel to a second axis defined by the lead port.

10. The lead connector according to claim 8, wherein The lead connector has an open position and a closed position, and wherein rotational transition from the open position to the closed position causes the blade to secure a portion of the lead into the blade channel.

11. The lead connector according to claim 8, wherein At least one of the sections of the blade includes a cutting edge to strip or sever the leads when the cover is rotatably pushed into the base to a closed position.

12. The lead connector according to claim 8, wherein The handle provides a snap fit to selectively couple the lead connector into a connector base.

13. The lead connector according to claim 12, wherein The handle is configured to release from the connector base when an inward force is applied to the handle and a side of the lead connector opposite the handle.

14. A stimulation lead connection system, comprising: a cable having a magnetic breakaway connection at a proximal end and a head at a distal end; The lead connector according to any one of claims 1 to 7, configured to electrically and mechanically interface with the header and to electrically and mechanically interface with a lead at least partially covered with an insulating layer; and A connector base is configured to selectively receive the lead connector, the connector base including an adhesive pad configured to adhere to the patient's skin.

15. The stimulation lead connection system of claim 14, further comprising a lead anchor for being attached to the lead and the patient between a proximal end of the lead attached to the lead connector and a distal end of the lead implanted in the patient.

16. The stimulation lead connection system according to claim 14, wherein: The lead anchor defines a plurality of suture holes to facilitate suturing the lead anchor to the patient.

17. The stimulation lead connection system according to claim 14 further includes a protective cover which, when installed, defines a cavity in which the lead connector and the connector base are installed and separates the lead connector and the connector base from the bandage that provides a waterproof barrier.

18. The stimulation lead connection system according to claim 17, wherein: The protective cover defines a connector port and includes a connector tray within the connector port, the connector tray being made of a material that prevents the bandage from sticking to the connector tray.

19. The stimulation lead connection system according to claim 18, wherein: The head of the cable includes a first annular magnet and a plug, the plug being configured to pass through the connector disk so that when connected to the lead connector, the body of the head remains outside the bandage and protective cover, and wherein the lead connector defines a receptacle to receive the plug to electrically couple to the head, and includes a second annular magnet for magnetically coupling to the first annular magnet to mechanically couple to the head through the protective cover.

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