Patent Description:
A spinal cord stimulator is a type of implantable neuromodulation device configured to send electrical stimulation pulses to areas of the spinal cord for the treatment of pain conditions. A spinal cord stimulator is a consideration for people who have a pain condition that has not responded to more conservative therapy.

Spinal cord stimulation therapies are not effective for all patients. Prior to receiving a permanent implant, it is common practice to utilize a screening approach to evaluate which patients respond to therapy. The screening consists of two phases: intraoperative testing and patient-worn trialing.

Intraoperative testing is an acute evaluation of the lead integrity and adequacy of lead positioning while in a surgical setting. An external pulse generator (EPG), an intraoperative test cable and an external lead adapter are used to perform the intraoperative testing. The external lead adapter and mated intraoperative test cable connects the external pulse generator to the leads, while at the same time allowing the external pulse generator to remain outside of the surgical sterile field. Intraoperative testing is performed during the placement of the temporary leads (for a trial) and permanent leads (for permanent implant). The external lead adapter is continued to be used to interface to the leads in patient-worn trialing, described below.

For patient-worn trialing, the external pulse generator and mated external lead adapter are affixed via dressings to the patient. The external pulse generator is affixed to the patient for a trial consisting between <NUM>-<NUM> days, with most trials not exceeding <NUM> days in the United States of America. The patient continues to wear the trial stimulator during normal daily activities. During this time a remote device is used to adjust therapy and to collect patient input feedback related to pain relief (e.g. surveys). Meanwhile, the external pulse generator autonomously collects statistics related to stimulation therapy usage patterns. These statistics are telemetered from the external pulse generator to the remote device e.g. via Bluetooth. These trial simulators are intended for single use and a single purpose. Therefore, the trials are expensive. In addition, the known trial simulators have electrical connectors that require to increase device size. However, for patient comfort, it is important to keep the trial simulator size small.

<CIT> describes an adapter system for connecting implantable electrode leads. The adapter system has a pulse generator configured to generate electrical stimulation pulses and has a first connector member. The adapter has a housing containing two receptacles. Each receptacle receives an end portion of an electrode lead to establish an electrical connection between the adapter and the electrode lead. The adapter contains a second connector member configured to engage with the first connector member to establish a mechanical connection between the housing and the pulse generator and an electrical connection between the pulse generator and the electrode lead. A test cable electrically connects the pulse generator to the electrode leads for testing the electrode leads. The test cable contains a first connector member configured to engage with the second connector member to establish an electrical connection. The test cable contains a second connector member configured to engage with the first connector member.

<CIT> relates to an adapter for an implantable cardiac lead, the adapter having a housing with an interior axial opening and an outer surface. The interior axial opening is configured to receive a mating terminal end of the implantable cardiac lead. A plurality of inner contacts are positioned within the interior axial opening and a plurality of outer contacts are positioned on the outer surface. Each of the inner contacts is electrically connected to an outer contact. The inner contacts are configured to electrically link with contacts on the mating terminal end of the implantable cardiac lead when the mating terminal end of the implantable cardiac lead is positioned within the interior opening. The outer surface is configured for connection of the outer contacts to a testing cable, the testing cable providing electrical connectivity with a device for testing the electrical continuity of the cardiac lead. An assembly including an adapter may be used to connect implanted cardiac leads with a testing device.

In light of the above, a system for neurological stimulation is provided that overcomes at least some of the problems in the art.

It is an object of the present disclosure to provide a system for neurological stimulation which is reusable and/or reduces costs of spinal cord stimulation therapies. It is another object of the present disclosure to improve patient comfort.

It is an object of the present disclosure to provide a system for neurological stimulation which is easy to manufacture, practical to use and robust.

The objects are solved by the features of the independent claims.

According to an independent aspect of the present disclosure, a system for neurological stimulation is provided. The system includes a pulse generator module, a first lead interface module, and a second lead interface module.

Preferably, the pulse generator module includes a first housing configured to accommodate a pulse generator unit, wherein the first housing further includes a coupling portion; and a first electrical interface located at the coupling portion. The pulse generator unit of the pulse generator module may be configured to generate neurological stimulation pulses to be supplied to at least one neurological stimulation electrode via the first electrical interface.

In some embodiments, the first housing may be made of a thermoplastic, such as a PC-ABS alloy.

The at least one neurological stimulation electrode may also be referred to as a "lead". The first lead interface module and the second lead interface module can both be referred to as "external lead adapter".

Preferably, the first lead interface module is connectable to the coupling portion and the first electrical interface of the pulse generator module.

Preferably, the first lead interface module may be detachably connectable to the at least one neurological stimulation electrode. In particular, the first lead interface module may be directly or indirectly connectable to the at least one neurological stimulation electrode.

Preferably, the second lead interface module may be connectable to the coupling portion and the first electrical interface.

Preferably, the second lead interface module may include an extension cable connectable or connected to an electrode coupling box for supplying the neurological stimulation pulses generated by the pulse generator unit to the at least one neurological stimulation electrode. The extension cable may be an interoperative test cable.

Only one of the first lead interface module and the second lead interface module can be connected to the pulse generator module at the same time. In other words, the first lead interface module and the second lead interface module are connectable to the same coupling portion and the same first electrical interface and thus, the first lead interface module and the second lead interface module are not simultaneously connectable to the pulse generator module.

According to a preferred embodiment, the first lead interface module is not connectable to the second lead interface module and vice versa. "Connectable" is understood as e.g. electrically couplable in a manner that electrical signals may be effectively transmitted from the first lead interface module to the second lead interface module and vice versa. If the first and second lead interface module are not connectable to each other, the number of series inter-connections for the inventive system is reduced, thus improving the reliability of the electrical connections, and reduces the overall design complexity, size and weight of the first lead interface module and second lead interface module. Moreover, intraoperative handling of said first and second lead interface module is facilitated for a user by reducing the number of connections.

In some embodiments, the first lead interface module may be connectable to the at least one neurological stimulation electrode during patient worn trialing to supply the neurological stimulation pulses to the at least one neurological stimulation electrode. Additionally, or alternatively, the second lead interface module may be connectable to the at least one neurological stimulation electrode during interoperative testing to supply the neurological stimulation pulses to the at least one neurological stimulation electrode. Accordingly, the system of the present disclosure may support two purposes: intraoperative testing (e.g. for both temporary and permanent leads) and patient-worn trialing.

According to the present invention, the first lead interface module and/or the second lead interface module includes at least one first connection means attachable to at least one second connection means of the coupling portion. The at least one first connection means and the at least one second connection means may be configured to engage with each other to mechanically connect the respective lead interface module with the pulse generator module.

For example, the at least one first connection means may include at least one protrusion and the at least one second connection means may include at least one recess (e.g. an opening or hole). Alternatively, the at least one first connection means may include at least one recess (e.g. an opening or hole) and the at least one second connection means may include at least one protrusion.

Thehe at least one first connection means and the at least one second connection means provide a rotational axis for the respective lead interface module so that the lead interface module is connectable to the coupling portion by means of a rotation of the lead interface module around the rotational axis. In particular, the at least one first connection means and the at least one second connection means may engage with each other while the lead interface module is tilted with respect to the pulse generator module, and the lead interface module may then be rotated around the rotational axis to align the lead interface module and the pulse generator module. For example, the lead interface module may be rotated to fit or insert the lead interface module into the coupling portion.

Preferably, the pulse generator module and/or the first lead interface module and/or the second lead interface module may include one or more clamps and/or one or more hinge elements configured to fix the lead interface module to the pulse generator module. For example, the one or more clamps and/or the one or more hinge elements may be rotatable around a rotational axis to interlock the lead interface module and the pulse generator module.

According to some embodiments, which can be combined with other embodiments described herein, the coupling portion has a shape essentially corresponding to an outer shape of the first lead interface module and/or the second lead interface module. Accordingly, the coupling portion may accommodate an outer shape of the first lead interface module and/or the second lead interface module.

Preferably, the coupling portion is formed as a cavity or recess on the first housing.

According to some embodiments, which can be combined with other embodiments described herein, the first lead interface module and/or the second lead interface module may include a second electrical interface electrically connectable to the first electrical interface. The second electrical interface may be configured to receive the neurological stimulation pulses generated by the pulse generator unit and supplied via the first electrical interface.

Preferably, the first lead interface module and/or the second lead interface module includes a second housing.

In some embodiments, the second housing may be made of a thermoplastic, such as a PC-ABS alloy.

Preferably, the second housing may have an interior space.

In some embodiments, a first portion of the second electrical interface is arranged at an outside of the second housing and a second portion of the second electrical interface is arranged in the interior space. The first portion may be configured to be electrically connected to the first electrical interface and the second portion may be configured to be (directly or indirectly) electrically connected to the at least one neurological stimulation electrode.

Preferably, the lead interface module, in particular the first lead interface module and not the second lead interface module, includes a lid configured to open or close the interior space of the second housing. In some embodiments, the lid may be rotatably connected to the second housing.

In some embodiments, the lid may be made of a thermoplastic, such as a PC-ABS alloy. Additionally, or alternatively, the lid may be made of a transparent, semi-transparent or opaque material.

According to some embodiments, which can be combined with other embodiments described herein, the first lead interface module and/or the second lead interface module includes a circuit board.

Preferably, the first portion of the second electrical interface is arranged at a first side of the circuit board and the second portion of the second electrical interface is arranged at a second side of the circuit board opposite the first side.

According to some embodiments, which can be combined with other embodiments described herein, the first electrical interface of the pulse generator module includes a plurality of pins, such as pogo pins.

Preferably, the first portion of the second electrical interface includes a plurality of recesses or a plurality of pads configured to engage with the plurality of pins of the first electrical interface when the lead interface module is connected to the coupling portion.

Preferably, the second portion of the second electrical interface includes a plurality of connection elements directly or indirectly connectable to the at least one neurological stimulation electrode.

Preferably, the plurality of connection elements, in particular of the first lead interface module and not the second lead interface module, are arranged to define at least one channel. Each channel may be configured to receive a conductive device or a conductive element. The conductive device may be a part of, or connected to, the at least one neurological stimulation electrode. In some embodiments, the conductive device may be an end portion of the at least one neurological stimulation electrode and may have a plurality of ring contacts.

Preferably, the plurality of connection elements may be configured to radially surround the conductive device. For example, the connection elements may be configured to contact corresponding ring contacts of the conductive device.

Preferably, each connection element of the plurality of connection elements is an essentially U-shaped element having an open top portion. The open top portion may be configured to allow an entry of the conductive device into an inside of the U-shape, in particular in a direction essentially perpendicular to a length extension of the conductive device.

Preferably, the U-shape of the connection element is such that the conductive device is held in the inside of the U-shape after the conductive device has been inserted.

Preferably, each connection element of the plurality of connection elements is formed by a piece of bent metal. The metal may be copper, beryllium copper, or gold. The metal may be also a stable material like beryllium copper with a gold coating or a passivation layer like gold.

Preferably, the plurality of connection elements includes at least one electrical connection element configured to provide the electrical connection to the at least one neurological stimulation electrode and at least one anchor element electrically isolated from the at least one neurological stimulation electrode. The at least one anchor element may be used to grip a non-electrical contact on the at least one neurological stimulation electrode and provide enhanced retention force.

Preferably, a configuration of the at least one electrical connection element and a configuration of the at least one anchor element are essentially identical.

Preferably, the plurality of connection elements are soldered to a circuit board of the lead interface module, in particular the first lead interface module.

Preferably, the plurality of connection elements are manufactured as a gang (e.g. <NUM> electrical contacts and <NUM> anchor contact) and then electrically isolated; this helps ensure uniformity in the dimensions of the connection elements.

According to some embodiments, which can be combined with other embodiments described herein, the plurality of connection elements of the second lead interface module are solder pads. The extension cable may be soldered to the solder pads. Accordingly, unlike the first lead interface module, the extension cable is fixedly connected to the second lead interface module and is not detachable.

According to some embodiments, which can be combined with other embodiments described herein, the system further includes the electrode coupling box. The electrode coupling box may be connectable or connected to the at least one neurological stimulation electrode. The electrode coupling box may be configured to electrically connect the second lead interface module and the at least one neurological stimulation electrode. Thereby, the neurological stimulation pulses generated by the pulse generator unit are transferred to the at least one neurological stimulation electrode via the electrode coupling box.

Preferably, the electrode coupling box may be mechanically connectable to the at least one neurological stimulation electrode. For example, the electrode coupling box may be detachably connectable to the at least one neurological stimulation electrode.

Preferably, the extension cable has a first end portion fixedly connected to the second lead interface module and a second end portion connected to the electrode coupling box.

Preferably, the electrode coupling box may be configured to electrically connect the second end portion of the extension cable and the at least one neurological stimulation electrode such that the neurological stimulation pulses generated by the pulse generator unit are transferred to the at least one neurological stimulation electrode via the second lead interface module, the extension cable, and the electrode coupling box.

According to another independent aspect of the present disclosure, which can be combined with the other aspects described herein, a system for neurological stimulation is provided. The system includes a pulse generator module and a lead interface module. The pulse generator module includes a first housing configured to accommodate a pulse generator unit, wherein the first housing includes a coupling portion; and a first electrical interface located at the coupling portion. The lead interface module is connectable to the coupling portion and at least one neurological stimulation electrode, wherein the lead interface module includes a second electrical interface connectable to the first electrical interface when the lead interface module is connected to the coupling portion, for supplying neurological stimulation pulses generated by the pulse generator unit to the at least one neurological stimulation electrode.

According to another independent aspect of the present disclosure, which can be combined with the other aspects described herein, a system for neurological stimulation is provided.

The system includes a pulse generator module having a first electrical interface, wherein the pulse generator module is configured to supply neurological stimulation pulses to at least one neurological stimulation electrode via the first electrical interface; a first lead interface module detachably connectable to the first electrical interface of the pulse generator module, wherein the first lead interface module is connectable to the at least one neurological stimulation electrode during patient worn trialing to supply the neurological stimulation pulses to the at least one neurological stimulation electrode; and a second lead interface module detachably connectable to the first electrical interface of the pulse generator module, wherein the second lead interface module is connectable to the at least one neurological stimulation electrode during interoperative testing to supply the neurological stimulation pulses to the at least one neurological stimulation electrode.

According to another independent aspect of the present disclosure, which can be combined with the other aspects described herein, a pulse generator module for neurological stimulation is provided. The pulse generator module includes a first housing having a coupling portion, wherein the coupling portion is releasably mechanically connectable to (one of) a first lead interface module and a second lead interface module different from the first lead interface module.

The pulse generator module may further include a first electrical interface located at the coupling portion, wherein the first electrical interface is arranged to be electrically connected to a second electrical interface of the first lead interface module when the first lead interface module is connected to the coupling portion, and another second electrical interface of the second lead interface module when the second lead interface module is connected to the coupling portion.

The first lead interface module may be connectable to the at last one neurological stimulation electrode during patient worn trialing to supply the pulses to the at last one neurological stimulation electrode. Additionally, or alternatively, the second lead interface module may be connectable to the at least one neurological stimulation electrode during interoperative testing to supply the pulses to the at last one neurological stimulation electrode.

According to another independent aspect of the present disclosure, which can be combined with the other aspects described herein, a lead interface module is provided. The lead interface module is detachably connectable to a pulse generator module, wherein the lead interface module is further connectable to at least one neurological stimulation electrode during patient worn trialing to supply neurological stimulation pulses generated by the pulse generator module to the at least one neurological stimulation electrode.

Preferably, the lead interface module is directly connectable to the at least one neurological stimulation electrode.

According to another independent aspect of the present disclosure, which can be combined with the other aspects described herein, a lead interface module is provided. The lead interface module is detachably connectable to a pulse generator module, wherein the lead interface module is connectable to at least one neurological stimulation electrode during interoperative testing to supply neurological stimulation pulses generated by the pulse generator module to the at least one neurological stimulation electrode.

Preferably, the lead interface module is connectable to the at least one neurological stimulation electrode via an extension cable and/or an electrode coupling box.

So that the manner in which the above recited features of the present disclosure can be understood in detail, a more particular description of the disclosure, briefly summarized above, may be had by reference to embodiments. The accompanying drawings relate to embodiments of the disclosure and are described in the following:.

Reference will now be made in detail to the various embodiments of the disclosure, one or more examples of which are illustrated in the figures. Within the following description of the drawings, the same reference numbers refer to same components. Generally, only the differences with respect to individual embodiments are described. Each example is provided by way of explanation of the disclosure and is not meant as a limitation of the disclosure. Further, features illustrated or described as part of one embodiment can be used on or in conjunction with other embodiments to yield yet a further embodiment. It is intended that the description includes such modifications and variations.

The present disclosure provides a system which includes a reusable external pulse generator that supports multiple modes of use, namely intraoperative testing and patient-worn trialing.

In particular, the same external pulse generator is connectable to two different lead interface modules, one of which can be used during intraoperative testing and another one which can be used during patient-worn trialing. This can reduce the cost of spinal cord stimulation therapies. Further benefits of the present disclosure are apparent from the following description and the accompanying drawings.

<FIG> shows a schematic view of a system <NUM> for neurological stimulation according to embodiments of the present disclosure.

The system <NUM> includes a pulse generator module <NUM>, a first lead interface module <NUM>, and a second lead interface module <NUM>. The pulse generator module <NUM> may also be referred to as "external pulse generator" (EPG).

Either the first lead interface module <NUM> or the second lead interface module <NUM> may be connected to the pulse generator module <NUM>. In other words, the first lead interface module <NUM> and the second lead interface module <NUM> are connectable to the same coupling portion <NUM> and the same first electrical interface <NUM> and thus, the first lead interface module <NUM> and the second lead interface module <NUM> are not simultaneously connectable to the pulse generator module <NUM>.

The pulse generator module <NUM> may include a first housing <NUM> configured to accommodate a pulse generator unit (not shown). The pulse generator unit may be configured to generate neurological stimulation pulses to be supplied to at least one neurological stimulation electrode <NUM>. The at least one neurological stimulation electrode <NUM> may also be referred to as a "lead".

The at least one neurological stimulation electrode <NUM> may include a portion that is placed percutaneously within the patient's body to deliver the neurological stimulation pulses to the spinal cord. The neurological stimulation electrode <NUM> may further have another portion outside the patient's body and which is connectable to the pulse generator module <NUM> via the first lead interface module <NUM> or the second lead interface module <NUM>. In particular, the first lead interface module <NUM> and the second lead interface module <NUM> may adapt the at least one neurological stimulation electrode <NUM>, such as one or more percutaneous leads, to the pulse generator module <NUM>.

For example, the at least one neurological stimulation electrode <NUM> may have an end portion which has a plurality of ring contacts <NUM> used to electrically connect the at least one neurological stimulation electrode <NUM> to the first lead interface module <NUM> and/or the second lead interface module <NUM>. The basic design of neurological stimulation electrodes is known in the art and is therefore not explained in detail.

The pulse generator module <NUM> supports the two detachable lead interface modules <NUM>, <NUM> with a common electrical and mechanical interface. For this purpose, the first housing <NUM> includes a coupling portion <NUM> and a first electrical interface <NUM>. The first electrical interface <NUM> is located at, or in, the coupling portion <NUM>. The neurological stimulation pulses generated by the pulse generator unit are supplied to the to at least one neurological stimulation electrode <NUM> via the first electrical interface <NUM>.

Expressions such as "detachably connected" and "releasably connected" are used to distinguish from "permanently connected" and "fixedly connected".

The first lead interface module <NUM> is connectable, in particular detachably connectable, to the coupling portion <NUM> and the first electrical interface <NUM> of the pulse generator module <NUM>. In particular, the first lead interface module <NUM> may be mechanically connectable to the coupling portion <NUM> and electrically connectable to the first electrical interface <NUM>.

The first lead interface module <NUM> may include a second electrical interface <NUM> electrically connectable to the first electrical interface <NUM>, for example, by means of a mechanical contact between the first electrical interface <NUM> and the second electrical interface <NUM>. The second electrical interface <NUM> may be configured to receive the neurological stimulation pulses generated by the pulse generator unit and supplied via the first electrical interface <NUM>.

Preferably, the first lead interface module <NUM> includes a second housing <NUM>. The second electrical interface <NUM> may be exposed from the second housing <NUM> e.g. via openings in the second housing <NUM> to allow a mechanical and therefore electrical contact between the first electrical interface <NUM> and the second electrical interface <NUM> when the first lead interface module <NUM> is mounted at the coupling portion <NUM>.

In some embodiments, the first lead interface module <NUM> may be detachably connectable to the at least one neurological stimulation electrode <NUM>. In particular, the first lead interface module <NUM> may be directly or indirectly connectable to the at least one neurological stimulation electrode <NUM>.

The direct connection means that the at least one neurological stimulation electrode <NUM> is connected to the first lead interface module <NUM> without intermediate means, such as cables or devices. For example, the second housing <NUM> of the first lead interface module <NUM> may have one or more openings <NUM> to allow an entry of the at least one neurological stimulation electrode <NUM>. In particular, an end portion of the at least one neurological stimulation electrode <NUM> may be insertable into the first lead interface module <NUM> via the one or more openings <NUM> to establish an electrical connection between the at least one neurological stimulation electrode <NUM> and the second electrical interface <NUM>.

The indirect connection means that the at least one neurological stimulation electrode <NUM> is connected to the first lead interface module <NUM> via one or more intermediate means, such as cables and/or devices. In this case, the intermediate means may be insertable into the first lead interface module <NUM> via the one or more openings <NUM> to establish an electrical connection between the intermediate means (and therefore the at least one neurological stimulation electrode <NUM>) and the second electrical interface <NUM>.

In some embodiments, the first lead interface module <NUM> is connected to the at least one neurological stimulation electrode <NUM> during patient worn trialing to supply the neurological stimulation pulses generated by the pulse generator module <NUM> to the at least one neurological stimulation electrode <NUM>.

The second lead interface module <NUM> is connectable, in particular detachably connectable, to the coupling portion <NUM> and the first electrical interface <NUM> of the pulse generator module <NUM>. In particular, the second lead interface module <NUM> may be mechanically connectable to the coupling portion <NUM> and electrically connectable to the first electrical interface <NUM>.

The second lead interface module <NUM> may include another second electrical interface <NUM> electrically connectable to the first electrical interface <NUM>, for example, by means of a mechanical contact between the first electrical interface <NUM> and the other second electrical interface <NUM>. The other second electrical interface <NUM> may be configured to receive the neurological stimulation pulses generated by the pulse generator unit and supplied via the first electrical interface <NUM>.

Preferably, the second lead interface module <NUM> includes another second housing <NUM>. The other second electrical interface <NUM> may be exposed from the other second housing <NUM> e.g. via one or more openings in the other second housing <NUM> to allow a mechanical and therefore electrical contact between the first electrical interface <NUM> and the other second electrical interface <NUM> when the second lead interface module <NUM> is mounted at the coupling portion <NUM>.

The system <NUM>, in particular the second lead interface module <NUM>, may include an extension cable <NUM> connectable or connected to an electrode coupling box <NUM> for supplying the neurological stimulation pulses generated by the pulse generator unit to the at least one neurological stimulation electrode <NUM>.

The extension cable <NUM> may have a first end portion 134a fixedly or permanently connected to the second lead interface module <NUM> and a second end portion 134b connected to the electrode coupling box <NUM>. The second end portion 134b may be permanently or detachably connected to the electrode coupling box <NUM>.

The electrode coupling box <NUM> may be electrically connectable or connected to the at least one neurological stimulation electrode <NUM> to establish an electrical connection between the second lead interface module <NUM> and the at least one neurological stimulation electrode <NUM>. Thereby, the neurological stimulation pulses generated by the pulse generator unit can be transferred to the at least one neurological stimulation electrode <NUM> via the electrode coupling box <NUM>.

The at least one neurological stimulation electrode <NUM> may be permanently or detachably connected to the electrode coupling box <NUM>.

In some embodiments, the electrode coupling box <NUM> may include a coupling box housing <NUM>. The coupling box housing <NUM> may have one or more openings <NUM> to allow an entry of the at least one neurological stimulation electrode <NUM>. In particular, an end portion of the at least one neurological stimulation electrode <NUM> may be insertable into the electrode coupling box <NUM> via the one or more openings <NUM> to establish an electrical connection between the at least one neurological stimulation electrode <NUM> and the extension cable <NUM>.

In some embodiments, the coupling box housing <NUM> may be made of a thermoplastic, such as a PC-ABS alloy.

In some embodiments, the second lead interface module <NUM> may be connectable to the at least one neurological stimulation electrode <NUM> during interoperative testing to supply the neurological stimulation pulses to the at least one neurological stimulation electrode <NUM>. Due to the extension cable <NUM>, the pulse generator module <NUM> and the second lead interface module <NUM> may remain outside of the surgical sterile field and only the electrode coupling box <NUM> may be located within the surgical sterile field. In <FIG> the surgical sterile field is indicated with a dashed line A. Accordingly, at least the pulse generator module <NUM> is reusable, especially since the electronics of the system <NUM> are contained therein and remain outside the surgical sterile field.

<FIG> show perspective views of a pulse generator module <NUM> according to embodiments of the present disclosure. <FIG> shows a perspective view of the pulse generator module <NUM> with mated lead interface module <NUM> or <NUM> according to embodiments of the present disclosure.

The first housing <NUM> of the pulse generator module <NUM> provides the coupling portion <NUM>, to which the first lead interface module <NUM> and the second lead interface module <NUM> are connectable. In some embodiments, the coupling portion <NUM> is formed as a cavity or recess on the first housing <NUM>. The cavity or recess may be configured to accommodate the first lead interface module <NUM> and/or the second lead interface module <NUM>, in particular an outer shape thereof.

For example, the coupling portion <NUM> can have a shape essentially corresponding to an outer shape of the first lead interface module <NUM> and/or the second lead interface module <NUM>. When the lead interface module is mounted to the coupling portion <NUM>, the outer shape of the lead interface module and the outer shape of the first housing <NUM> of the pulse generator module <NUM> may be flush. As is shown in <FIG>, this can improve the appearance, as the pulse generator module <NUM> and the lead interface module connected thereto have a continuous and smooth exterior.

According to some embodiments, which can be combined with other embodiments described herein, the first lead interface module <NUM> and/or the second lead interface module <NUM> can include at least one first connection means attachable to at least one second connection means <NUM> of the coupling portion <NUM>. The at least one first connection means and the at least one second connection means <NUM> may be configured to engage with each other to mechanically connect the respective lead interface module to the pulse generator module <NUM>. This will be discussed in more detail later with reference to <FIG>.

According to some embodiments, which can be combined with other embodiments described herein, the pulse generator module <NUM> can include holding means configured to secure and/or retain the lead interface module once the lead interface module has been mounted to the coupling portion <NUM>. In particular, the holding means may be configured to mechanically retain the lead interface module from lateral and rotational movement once secured.

For example, the holding means may include at least one holding protrusion and at least one holding recess <NUM> configured to engage with the at least one holding protrusion. The at least one holding protrusion can be a fin, and the at least one holding recess can be a corresponding cavity. An alternative circular configuration of the holding means is shown in <FIG>.

In the example of <FIG>, the at least one holding recess <NUM> is provided at the first housing <NUM>, particularly the coupling portion <NUM>. Corresponding holding protrusions are provided at the lead interface module (not shown). Alternatively, the at least one holding protrusion is provided at the first housing <NUM>, particularly the coupling portion <NUM>. Corresponding holding recesses can be provided at the lead interface module.

Additionally, or alternatively, the holding means can include one or more clamps and/or one or more hinge elements configured to fix the lead interface module to the pulse generator module <NUM>. The clamps/hinges will be discussed in more detail later with reference to <FIG> and <FIG>.

In some embodiments, the pulse generator module <NUM> may include at least one indicator <NUM> configured to indicate an operational state of the system <NUM>, such as ON or OFF. Other operational states can be: Bluetooth pairing mode entry or battery attach feedback. The at least one indicator <NUM> may be located at the first housing <NUM>. The at least one indicator <NUM> may be a light source, such as an LED and/or a multi-color light source.

<FIG> show perspective views of a first lead interface module <NUM> according to embodiments of the present disclosure. <FIG> shows a top view of the first lead interface module <NUM>. <FIG> shows a bottom view of the first lead interface module <NUM>. <FIG> shows a side view of the first lead interface module <NUM>.

According to some embodiments, which can be combined with other embodiments described herein, the first lead interface module <NUM> includes at least one first connection means <NUM> attachable to the at least one second connection means <NUM> of the pulse generator module <NUM> shown in <FIG>. The at least one first connection means <NUM> and the at least one second connection means <NUM> may be configured to engage with each other to mechanically connect the first lead interface module <NUM> and the pulse generator module.

For example, the at least one first connection means <NUM> includes at least one protrusion and the at least one second connection means <NUM> includes at least one recess (e.g. an opening or hole). Alternatively, the at least one first connection means includes at least one recess (e.g. an opening or hole) and the at least one second connection means <NUM> includes at least one protrusion.

Preferably, the at least one first connection means <NUM> and the at least one second connection means <NUM> provide a rotational axis for the first lead interface module <NUM> so that the first lead interface module <NUM> is connectable to the coupling portion by means of a rotation of the first lead interface module <NUM> around the rotational axis. In particular, the at least one first connection means <NUM> and the at least one second connection means <NUM> may engage with each other while the first lead interface module <NUM> is tilted with respect to the pulse generator module, and the first lead interface module <NUM> may then be rotated downwards around the rotational axis to align the first lead interface module <NUM> and the pulse generator module. For example, the first lead interface module <NUM> may be rotated to fit or insert the first lead interface module <NUM> into the coupling portion, as it is shown in <FIG>. Preferably, the first lead interface module <NUM> includes the second housing <NUM>. The second housing <NUM> may have an interior space and a lid <NUM> configured to open or close the interior space of the second housing <NUM>. For example, the second housing <NUM> may define the interior space and may have an open top portion covered by the lid <NUM>.

In some embodiments, the lid <NUM> may be rotatably connected to the second housing <NUM> by means of a rotational axis <NUM>. The rotational axis <NUM> may be provided at a side of the interior space opposite to a side at which the at least one first connection means <NUM> is located. In other words, the interior space may be located between the at least one first connection means <NUM> and the rotational axis <NUM>. Therefore, the lid <NUM> can be opened by rotating it outward.

In some embodiments, the second housing <NUM> of the first lead interface module <NUM> may have one or more openings <NUM> to allow an entry of the at least one neurological stimulation electrode <NUM>. In particular, an end portion <NUM> of the at least one neurological stimulation electrode <NUM> may be insertable into the first lead interface module <NUM>, in particular the interior space, via the one or more openings <NUM> to establish an electrical connection between the at least one neurological stimulation electrode <NUM> and the second electrical interface <NUM>.

For example, the end portion <NUM> of the at least one neurological stimulation electrode <NUM> may have plurality of ring contacts <NUM> used to electrically connect the at least one neurological stimulation electrode <NUM> to the first lead interface module <NUM>.

In some implementation, the electrical connection between the at least one neurological stimulation electrode <NUM> and the second electrical interface <NUM> can be established by means of a conductive channel C into which the at least one neurological stimulation electrode <NUM> or the end portion <NUM> thereof is insertable. The content of the interior space, in particular the conductive channel C, will be discussed in more detail later with reference to FIGs. 4B and <FIG>.

In some implementations, the first lead interface module <NUM> includes one or more clamps and/or one or more hinge elements <NUM> configured to fix the first lead interface module <NUM> to the pulse generator module. For example, the one or more clamps and/or the one or more hinge elements <NUM> may be rotatable around a rotational axis to interlock the first lead interface module <NUM> and the pulse generator module. In particular, a rotating hinge may be provided which snaps into place on the pulse generator module when the first lead interface module <NUM> is fully seated in the coupling portion of the pulse generator module.

In some embodiments, the rotating axis of the one or more clamps and/or one or more hinge elements <NUM> and the rotating axis <NUM> of the lid may be the same rotating axis.

The second lead interface module can be configured similar to the first lead interface module and a description of similar or identical aspects is omitted. In particular, the second lead interface module can include the holding means and/or the second housing and/or the at least one first connection means and/or the one or more clamps/hinges and/or the lid.

<FIG> shows a perspective view of a circuit board <NUM> of the first lead interface module. <FIG> shows a schematic view of conductive channels C for connecting a neurological stimulation electrode to the first lead interface module.

The circuit board <NUM> may be arranged in the interior space of the second housing and may be connected to, or part of, the second electrical interface of the first lead interface module which is connectable to the first electrical interface of the pulse generator module.

The circuit board <NUM> may have a first side and a second side opposite the first side. The first side may face a bottom of the second housing, and the second side may face the open top portion of the interior space, in particular the lid.

Different portions of the second electrical interface can be located on the first side and the second side of the circuit board <NUM>, and some parts of the second electrical interface can penetrate the circuit board <NUM> to connect the different portions of the second electrical interface.

In some embodiments, a first portion of the second electrical interface is exposed to an outside of the second housing e.g. via one or more openings in the second housing, and a second portion of the second electrical interface is arranged in the interior space. The first portion may be configured to be electrically connected to the first electrical interface and the second portion may be configured to be (directly or indirectly) electrically connected to the at least one neurological stimulation electrode <NUM> or the end portion <NUM> thereof which has the plurality of ring contacts.

Preferably, the first portion of the second electrical interface is arranged at the first side of the circuit board <NUM> and the second portion of the second electrical interface is arranged at the second side of the circuit board <NUM> opposite the first side.

In order to electrically connect the second electrical interface to the first electrical interface of the pulse generator module, the first electrical interface of the pulse generator module may include a plurality of pins, such as an array of pins and/or pogo pins. The first portion of the second electrical interface may include a plurality of recesses or a plurality of pads, such as copper pads, configured to engage with the plurality of pins of the first electrical interface when the lead interface module is connected to the coupling portion. The pins will be discussed in more detail later with reference to <FIG>.

The second portion of the second electrical interface, which is located at the second side of the circuit board, may include a plurality of connection elements <NUM> directly connectable to the at least one neurological stimulation electrode <NUM> or the end portion <NUM> thereof. The plurality of connection elements <NUM> can be soldered to the circuit board <NUM>, in particular the second side of the circuit board <NUM>. The plurality of connection elements <NUM> can be electrically connected to the first portion of the second electrical interface, such as the plurality of recesses or plurality of pads which are configured to engage with the plurality of pins of the first electrical interface.

Preferably, the plurality of connection elements <NUM> are arranged to define at least one conductive channel C. Each channel C may be configured to receive a conductive device of the at least one neurological stimulation electrode <NUM> or connected to the at least one neurological stimulation electrode <NUM>. In some embodiments, the conductive device may be an external part of the at least one neurological stimulation electrode <NUM>, such as the end portion <NUM> of the at least one neurological stimulation electrode <NUM>.

Preferably, the plurality of connection elements <NUM> are configured to radially surround the conductive device, such as the end portion <NUM> or the ring contacts of the end portion <NUM>.

In the example of <FIG>, two conductive channels and two neurological stimulation electrodes <NUM> respectively connected to the conductive channels are shown. However, the present disclosure is not limited thereto, and one conductive channel and one corresponding neurological stimulation electrode can be provided, or three or more conductive channels and three or more corresponding neurological stimulation electrodes can be provided.

Referring to <FIG>, the plurality of connection elements <NUM> may include at least one electrical connection element <NUM> configured to provide the electrical connection to the at least one neurological stimulation electrode <NUM> (e.g. the ring contacts of the end portion <NUM>) and at least one anchor element <NUM> electrically isolated from the at least one neurological stimulation electrode <NUM>. The at least one anchor element <NUM> may be used to grip a non-electrical contact on the at least one neurological stimulation electrode <NUM> and provide enhanced retention force.

Preferably, a configuration of the at least one electrical connection element <NUM> and a configuration of the at least one anchor element <NUM> are essentially identical. The expression "essentially identical" means that shape and/or cross-sections of the elements are the same. However, a length of the elements may be different. For example, a length of the at least one anchor element <NUM> in a length direction of the conductive channel C may be larger than a length of the at least one electrical connection element <NUM> in the length direction of the conductive channel C.

In some embodiments, the plurality of connection elements <NUM> can be manufactured as at least one gang (e.g. <NUM> electrical contacts and <NUM> anchor contact per conductive channel or <NUM>-pol percutaneous lead) and then electrically isolated; this helps ensure uniformity in the dimensions of the connection elements.

<FIG> shows a perspective view of a connection element <NUM> used to form the conductive channel.

In some embodiments, the connection element <NUM> is an essentially U-shaped element having an open top portion <NUM>. The open top portion <NUM> may be configured to allow an entry of the conductive device, such as the end portion <NUM> of the neurological stimulation electrode <NUM>, into an inside or cavity <NUM> of the U-shape. For example, the open top portion <NUM> may be configured to allow an entry of the conductive device into the inside or cavity <NUM> of the U-shape in a direction essentially perpendicular to a length extension of the conductive channel and/or the conductive device <NUM>.

Preferably, the U-shape of the connection element <NUM> is such that the conductive device is held in the inside of the U-shape after the conductive device has been inserted. For example, the U-shape may have inwardly bent legs <NUM> which are pushed in opposite directions to enlarge the open top portion <NUM> when the conductive device is inserted. An elasticity of the material of the connection element <NUM> may provide a restoring force which attempts to move the outwardly bent legs <NUM> inwards to their initial or neutral position, thereby providing a clamping force holding the conductive device inside the U-shape.

Accordingly, the connection element <NUM> deforms outwardly to receive the conductive device, such as the end portion of the neurological stimulation electrode, and its ring contacts, hold it in place and make electrical contact. The conductive device may be flush or sub flush in all connection elements <NUM> when fully inserted.

The connection element <NUM> may include a smooth guiding portion which directs the (e.g. circular) conductive device e.g. with ring contacts into the inside of the connection element <NUM> where the conductive device is retained when the conductive device is pressed into an array of connection elements <NUM>. For example, the bent legs <NUM> may have outwardly bent edges <NUM> at the open top portion <NUM> to facilitate the guiding of the conductive device.

In some embodiments, the connection element <NUM> can include a solderable surface <NUM> to adhere to the circuit board of the first lead interface module e.g. using surface mount soldering technology. The solderable surface <NUM> may be an essentially flat surface and/or can be located at a side of the connection element <NUM> opposite the open top portion <NUM>.

Preferably, the connection elements are soldered down as a gang and subsequently electrically isolated by cutting them apart.

Preferably, the connection element <NUM> is formed by a piece of bent metal. Additionally, or alternative, the metal may be copper, beryllium copper, or gold.

<FIG> shows a side view of a pulse generator module with mated first lead interface module according to embodiments of the present disclosure. <FIG> shows a perspective view of a lid <NUM> of the lead interface module according to embodiments of the present disclosure.

The lid <NUM> may be configured to open or close the interior space of the second housing <NUM> of the first lead interface module. In some embodiments, the lid <NUM> may be rotatably connected to the second housing <NUM> by means of a rotational axis <NUM>. The lid <NUM> can be opened by rotating it outward.

The lid <NUM> can include one or more ribs <NUM> to enhance a rigidity of the lid <NUM>. In some embodiments, the one or more ribs <NUM> do not contact the portion of the neurological stimulation electrode(s) located in the second housing <NUM>.

According to some embodiments, which can be combined with other embodiments described herein, the lid <NUM> may be made of a transparent or semi-transparent material. For example, the lid <NUM> may be made of plastic, such as an opaque plastic.

Although the lid <NUM> has been described with reference to the first lead interface module, it is to be understood that the second lead interface module may have a similar or identical lid. However, in other embodiments, the second lead interface module may not a lid which can be opened. In particular, the second lead interface module may not have a lid at all.

<FIG> shows a schematic view of a second lead interface module <NUM>, an extension cable <NUM>, and an electrode coupling box <NUM> according to embodiments of the present disclosure.

The extension cable <NUM> may have a first end portion <NUM> fixedly or permanently connected to the second lead interface module <NUM> and a second end portion 134b connected to the electrode coupling box <NUM>. The second end portion 134b may be permanently or detachably connected to the electrode coupling box <NUM>.

In some embodiments, the extension cable <NUM> has a length of at least <NUM>, preferable at least <NUM>,<NUM>, and more preferably at least <NUM>.

The second lead interface module <NUM> is connectable to the pulse generator module. The electrode coupling box <NUM> is connectable to the at least one neurological stimulation electrode. The at least one neurological stimulation electrode <NUM> may be permanently or detachably connected to the electrode coupling box <NUM>. Neurological stimulation pulses generated by the pulse generator unit can be supplied to the at least one neurological stimulation electrode <NUM> via the second lead interface module <NUM>, the extension cable <NUM>, and the electrode coupling box <NUM>.

<FIG> shows the second lead interface module <NUM> and the first or proximal end portion 134a of the extension cable <NUM>.

The second lead interface module <NUM> may have a circuit board in an interior thereof. The circuit board may be configured similarly to the circuit board of the first interface module explained with respect to <FIG>. Therefore, a description of similar or identical aspects is not repeated.

The circuit board of the second lead interface module <NUM> may not have the U-shaped connection elements described with respect to <FIG> at the second side thereof. Instead, the plurality of connection elements at the second side of the circuit board may be solder pads. The extension cable <NUM> may be soldered to the solder pads. Accordingly, unlike the first lead interface module, the extension cable <NUM> is permanently connected to the second lead interface module and is not detachable.

<FIG> shows a schematic view of an electrode coupling box <NUM> according to embodiments of the present disclosure. <FIG> shows a detailed view of a section of the electrode coupling box <NUM> of <FIG>.

The second or distal end 134b of the extension cable is connected to the electrode coupling box <NUM>. Further, the at least one neurological stimulation electrode <NUM> may be permanently or detachably connected to the electrode coupling box <NUM>. The electrode coupling box <NUM> may be configured to electrically connect the second or distal end 134b of the extension cable (and thus the second lead interface module and pulse generator module) and the at least one neurological stimulation electrode <NUM>. Thereby, the neurological stimulation pulses generated by the pulse generator unit are transferred to the at least one neurological stimulation electrode <NUM> via the electrode coupling box <NUM>.

In some embodiments, the electrode coupling box <NUM> may include a coupling box housing <NUM>. The coupling box housing <NUM> may have one or more openings <NUM> to allow an entry of the at least one neurological stimulation electrode <NUM>. In particular, an end portion <NUM> of the at least one neurological stimulation electrode <NUM> may be insertable into the electrode coupling box <NUM> via the one or more openings <NUM> to establish an electrical connection between the at least one neurological stimulation electrode <NUM> and the extension cable <NUM>.

In some implementations, the at least one neurological stimulation electrode <NUM> may enter the electrode coupling box <NUM> at a first side thereof via the one or more openings <NUM>. A stylet hub support <NUM> may be provided at a second side of the electrode coupling box <NUM> opposite the first side.

The leads are hollow internally (have a lumen). Since the leads are very flexible the clinician needs a way to steer and locate the tips. For intraoperative use case only: the clinician inserts a stylet (metal wire) in the lumen of the lead and steers the lead distal end by controlling a plastic hub on the proximal end. The key here is that the IOC has to receive a lead with an already inserted stylet in its lumen and the stylet hub cannot interfere with the intraoperative testing.

<FIG> the stylet hubs or stylet hub supports <NUM> are outside the connector, used for steering lead. The channel spans the entire width of the device or electrode coupling box <NUM>.

The stylet component is used in the placement of the stimulation electrodes within the patient, providing a semi-rigid 'guide wire' for the flexible lead to be steered into position. During intraoperative testing it is necessary that the neurological stimulation electrodes be placed in the electrode coupling box <NUM> without removing the stylets. During testing, if the leads require a placement revision for better therapy this can be easily achieved by opening the cover, revising the lead electrode position within the patient, then re-installing in coupling box <NUM>.

The electrode coupling box <NUM>, in particular the coupling box housing <NUM>, may have an interior space having connection means therein configured to electrically connect the extension cable <NUM> and the at least one neurological stimulation electrode <NUM>. For example, the connection means may include a plurality of connection elements, such as the U-shaped connection elements explained with respect to <FIG>, which can be used to connect the extension cable <NUM> and the at least one neurological stimulation electrode <NUM> to each other.

For example, the at least one neurological stimulation electrode <NUM> or the end portion thereof can be inserted in a conductive channel formed by the plurality of connection elements. The plurality of connection elements can be soldered to a circuit board. Further, the extension cable <NUM> can be connected, for example soldered, to the circuit board such that an electrical connection e.g. between ring contacts of the at least one neurological stimulation electrode <NUM> and individual wires of the extension cable <NUM> can be established.

In some embodiments, the electrode coupling box <NUM> may be detachably connectable to the at least one neurological stimulation electrode <NUM>, for instance by means of the U-shaped connection elements. Additionally, or alternatively, the extension cable <NUM> may be permanently connected to the electrode coupling box <NUM>. For example, the extension cable <NUM> may be soldered to the circuit board which is located in the interior of the coupling box housing <NUM>.

In some embodiments, the electrode coupling box <NUM> may have a lid similar or identical to the lid described with respect to the first lead interface module. In other embodiments, the electrode coupling box <NUM> does not have a lid but a fixed cover <NUM>'.

In some embodiments, the fixed cover <NUM>' may be made of a thermoplastic, such as a PC-ABS alloy. Additionally, or alternatively, the fixed cover <NUM>' may be made of a transparent or semi-transparent material.

For example, the fixed cover <NUM>' may be transparent or semi-transparent to allow a user to see the interior of the electrode coupling box <NUM>, in particular an area in which the at least one neurological stimulation electrode <NUM> is connected to the electrode coupling box <NUM>, in particular the circuit board.

According to some implementations, the coupling box housing <NUM> may include a recess or cavity <NUM> on a side, in particular an upper side, thereof. The recess or cavity <NUM> may be configured to accommodate a user's thumb. Accordingly, the user can firmly hold the electrode coupling box <NUM> e.g. during the insertion of the at least one neurological stimulation electrode <NUM> into the coupling box housing <NUM>.

<FIG> shows a cross-sectional view of a pulse generator module with mated first or second lead interface module according to embodiments of the present disclosure. <FIG> shows a perspective view of an interior of a pulse generator module according to embodiments of the present disclosure.

The lead interface module includes the circuit board <NUM> which may be arranged in the interior space <NUM> of the second housing <NUM> and may be connected to, or part of, the second electrical interface of the lead interface module which is connectable to the first electrical interface of the pulse generator module. The pulse generator module may have pulse generation circuitry <NUM>.

The circuit board <NUM> may have a first side and a second side opposite the first side. The first side may face a bottom of the second housing <NUM>, and the second side may face the open top portion of the interior space <NUM>, in particular the lid <NUM>.

In some embodiments, a first portion of the second electrical interface is exposed to an outside of the second housing <NUM> e.g. via one or more openings in the second housing <NUM>, and a second portion of the second electrical interface is arranged in the interior space <NUM>. The first portion may be configured to be electrically connected to the first electrical interface and the second portion may be configured to be (directly or indirectly) electrically connected to the at least one neurological stimulation electrode or an end portion thereof.

In order to electrically connect the second electrical interface to the first electrical interface <NUM> of the pulse generator module, the first electrical interface <NUM> of the pulse generator module may include a plurality of pins <NUM>, such as male pins and/or pogo pins. For example, a number of the pins may be <NUM>, <NUM> or more. The first portion of the second electrical interface may include a plurality of recesses or a plurality of pads, such as copper pads, on the first side of the circuit board <NUM> and configured to engage with the plurality of pins <NUM> of the first electrical interface <NUM> when the lead interface module is connected to the coupling portion.

In some embodiments, the pulse generator module may include one or more energy sources <NUM>, such as batteries, in particular rechargeable and/or replaceable batteries.

According to some embodiments, which can be combined with other embodiments described herein, the pulse generator module may include a magnetic activation switch. For example, the pulse generator module may be switched on when a magnet, such as a permanent magnet, is brought into proximity of the magnetic activation switch and/or is moved in a particular direction. The pulse generator module may be switched off when the magnet is again brought into proximity of the magnetic activation switch and/or is moved in another direction.

In some embodiments, the pulse generator module may include at least one indicator <NUM> configured to indicate an operational state of the system. The at least one indicator <NUM> may be configured to indicate multiple patterns e.g. for "battery inserted", "RF/BLT association", "therapy active" and "magnetic activation".

The at least one indicator <NUM> may be a light source, such as an LED, preferably a single color LED.

According to some embodiments, which can be combined with other embodiments described herein, the pulse generator module may include a communication device configured for wireless communication. For example, the communication device may use RF and/or Bluetooth technology to wirelessly communicate with one or more external devices, such as remote devices. The one or more external devices may be provided to adjust therapy and/or collect patient feedback related to pain relief (e.g. surveys). Further, the pulse generator module <NUM> may autonomously collect statistics related to stimulation therapy usage patterns. These statistics can be telemetered from the pulse generator module <NUM> to the remote device using the communication device.

<FIG> shows a bottom view of a pulse generator module <NUM> according to embodiments of the present disclosure.

In some embodiments, the pulse generator module <NUM> includes a space configured to accommodate the one or more energy sources, such as batteries. The space may be closed by a cover or door 112a. The cover or door 112a may be removeable to allow a user to access the space and replace the one or more energy sources.

In some implementations, one or more test points (not shown) configured for functional tests after production may be located in the space so as to be accessible when the cover or door 112a is removed.

<FIG> further illustrates a recess <NUM> which is configured to engage with the one or more clamps and/or one or more hinge elements configured to fix the lead interface module to the pulse generator module. The recess <NUM> may be a hinge "lip".

<FIG> shows a top view of a pulse generator module <NUM> and an interface cap <NUM> according to embodiments of the present disclosure.

The interface cap <NUM> may be connectable to the first electrical interface <NUM> when no lead interface module is mounted thereon to protect the first electrical interface <NUM> from dust, humidity and damage during cleaning and storage. The interface cap <NUM> may be made of a semi-rigid material.

<FIG> further illustrates another embodiment of holding means configured to secure and/or retain the lead interface module once the lead interface module has been mounted to the coupling portion <NUM>. In particular, the holding means may be configured to mechanically retain the lead interface module the lateral and rotational movement once secured.

The holding means may include at least one holding protrusion and at least one holding recess configured to engage with the at least one holding protrusion. The at least one holding protrusion <NUM>' may be provided at the pulse generator module, and the at least one holding recess may be provided at the lead interface module. Alternatively, the at least one holding protrusion may be provided at the lead interface module, and the at least one holding recess may be provided at the pulse generator module.

In the example of <FIG>, the least one holding protrusion <NUM>' and/or the at least one holding recess have a circular shape.

The present disclosure provides a system which includes a reusable external pulse generator that supports multiple modes of use, namely intraoperative testing and patient-worn trialing. In particular, the same external pulse generator is connectable to two different lead interface modules, one of which can be used during intraoperative testing and another one which can be used during patient-worn trialing. This can reduce the cost of spinal cord stimulation therapies. Further benefits of the present disclosure are apparent from the following description and the accompanying drawings.

Claim 1:
A system (<NUM>) for neurological stimulation, comprising:
- a pulse generator module (<NUM>), including:
a first housing (<NUM>) configured to accommodate a pulse generator unit,
wherein the first housing (<NUM>) further includes a coupling portion (<NUM>); and
a first electrical interface (<NUM>) located at the coupling portion (<NUM>),
wherein the pulse generator unit is configured to generate neurological stimulation pulses to be supplied to at least one neurological stimulation electrode (<NUM>) via the first electrical interface (<NUM>);
- a first lead interface module (<NUM>) connectable to the coupling portion (<NUM>) and the first electrical interface (<NUM>), wherein the first lead interface module (<NUM>) is detachably connectable to the at least one neurological stimulation electrode (<NUM>); and
- a second lead interface module (<NUM>) connectable to the coupling portion (<NUM>) and the first electrical interface (<NUM>), wherein the second lead interface module (<NUM>) includes an extension cable (<NUM>) connectable to an electrode coupling box (<NUM>) for supplying the neurological stimulation pulses generated by the pulse generator unit to the at least one neurological stimulation electrode (<NUM>),
wherein at least one of the first lead interface module (<NUM>) and the second lead interface module (<NUM>) includes at least one first connection means (<NUM>) attachable to at least one second connection means (<NUM>) of the coupling portion (<NUM>); and
wherein the at least one first connection means (<NUM>) and the at least one second connection means (<NUM>) provide a rotational axis for the respective lead interface module (<NUM>, <NUM>) so that the lead interface module (<NUM>, <NUM>) is connectable to the coupling portion (<NUM>) by means of a rotation of the lead interface module (<NUM>, <NUM>) around the rotational axis.