Patent Description:
Implantable systems for photobiomodulation (PBM) can also provide therapeutic benefits in a variety of diseases and disorders. A photobiomodulation system may include a control module with one or more light sources and, often, one or more optical fibers to carry the light to the desired photobiomodulation site. Photobiomodulation can produce a variety of effects including, but not limited to, stimulation, augmentation, inhibition, or the like or any combination thereof. In this context, reference is made to document <CIT>.

In one aspect, a photobiomodulation system includes a) a control module having a housing, an electronic subassembly disposed in the housing, a connector coupled or coupleable to the housing and defining a lead coupling end, a catheter coupling end, and a connector lumen extending from the lead coupling end to the catheter coupling end, and at least one light source electrically coupled to the electronic subassembly and configured to produce light in response to signals from the electronic subassembly; b) a lead coupled or coupleable to the control module and having a distal portion spaced apart from the control module, the lead having a lead body defining a lead lumen that is configured for positioning in fluid communication with the connector lumen of the connector of the control module, the lead body further defining at least one opening along the distal portion of the lead and in fluid communication with the lead lumen, a plurality of light emitters arranged along the distal portion of the lead, and a plurality of optical fibers extending along the lead body and coupled to the light emitters and configured to receive light from the at least one light source and deliver the light to the light emitters; and c) a catheter assembly having a tube coupleable to a catheter pump, and a distal connector attached to an end of the tube and coupled or coupleable to the catheter coupling end of the connector of the control module, the distal connector including an assembly lumen extending from the tube and configured for fluid communication with the connector lumen of the connector of the connector of the control module.

In at least some aspects, the at least one light source is a plurality of light sources disposed in a radial arrangement. In at least some aspects, the light emitters are disposed in a radial arrangement. In at least some aspects, the photobiomodulation further includes an imaging device disposed on the distal portion of the lead. In at least some aspects, the connector of the control module further includes electrical contacts and the lead includes conductors coupled to the imaging device and configured for electrically coupling the electrical contacts.

In at least some aspects, the photobiomodulation further includes the catheter assembly further includes the catheter pump. In at least some aspects, the distal connector includes a needle defining a portion the assembly lumen. In at least some aspects, either the connector or the lead body includes a septum disposed in the connector lumen or the lead lumen, respectively.

In at least some aspects, the photobiomodulation system further includes a coupling arrangement for coupling the distal connector of the catheter assembly to the catheter coupling end of the connector. In at least some aspects, the connector is detachable from the housing. In at least some aspects, the connector further includes at least one cylindrical lens to receive the light from the at least one light source.

In at least some aspects, the control module further includes a power source disposed in the housing and coupled to the electronic subassembly. In at least some aspects, the connector of the control module further includes one or more seals disposed within or adjacent at least one of the catheter coupling end or the lead coupling end to hinder flow of fluid past the one or more seals. In at least some aspects, the photobiomodulation system further includes a programming unit configured to communicate with the electronic subassembly of the control module. In at least some aspects, the photobiomodulation system further includes an imaging device disposed on the distal portion of the lead, wherein the programming unit is configured to display images from the imaging device.

Another aspect is a delivery tool for delivery of the lead of any of the photobiomodulation systems described above. The delivery tool includes a hand grip arrangement; a barrel attached to the hand grip arrangement; a scissor grip for gripping the lead, the scissor grip extending out of the barrel and operatively coupled to the hand grip arrangement, wherein operation of the hand grip arrangement opens and closes the scissor grip; and a vertical steering mechanism extending from the barrel and coupled to the scissor grip to move the scissor grip up and down relative to the barrel without opening or closing the scissor grip.

In at least some aspects, the vertical steering mechanism includes a steering disc, at least one tab extending from the steering disc for rotating the steering disc relative to the barrel, and steering cables attached to, and extending between, the steering disc and scissor grip.

A further aspect is a method of implanting the lead of any of the photobiomodulation systems described above. The method includes holding the distal portion of the lead using a delivery tool; inserting the delivery tool into the patient; guiding the delivery tool and lead to the site of photobiomodulation; and releasing the distal portion of the lead from the delivery tool.

In at least some aspects, the lead further includes an imaging device disposed on the distal portion of the lead, wherein guiding and lead the delivery tool includes receiving images from the imaging device to guide the delivery tool and lead to the site of photobiomodulation. In at least some aspects, the delivery tool includes a vertical steering mechanism to move a grip of the delivery tool up or down, wherein guiding the delivery tool and lead includes using the vertical steering mechanism to facilitate guidance of the delivery tool and lead to the site of photobiomodulation.

Non-limiting and non-exhaustive embodiments of the present invention are described with reference to the following drawings. In the drawings, like reference numerals refer to like parts throughout the various figures unless otherwise specified.

The present disclosure is directed to the area of implantable photobiomodulation systems and delivery devices and methods of making and using the systems and devices. The present disclosure is also directed to implantable photobiomodulation systems that include an arrangement for delivery of medication or other materials.

Photobiomodulation (PBM) can be used to produce effects in the tissue of a patient including, but not limited to, stimulation, augmentation, inhibition, or the like or any combination thereof. PBM can be used to provide treatment for variety of diseases and disorders depending, at least in part, on the site of implantation and the wavelength(s) of light delivered. Photobiomodulation may include, but is not necessarily limited to, stimulation or other effects resulting from response to particular wavelengths or wavelength ranges of light or from thermal effects generated using light or any combination thereof.

As an example, for treatment of diabetes, it is believed that insulin production can be augmented by the application of PBM therapy to β-cells, such as β-cells found in the islets of Langerhans in the pancreas. Exocytosis of the β-cells is dependent on mitochondria production of ATP. It is believed that PBM therapy can increase the performance of the mitochondria in the β-cells to increase ATP production which can depolarize the cell membrane to allow calcium ions to pass through the cell membrane initiating exocytosis and the release of insulin from the β-cells.

<FIG> is a schematic side view of one embodiment of a photobiomodulation (PBM) system <NUM>. The PBM system <NUM> includes a lead <NUM>, a control module (or implantable pulse generator (IPG)) <NUM>, and a catheter assembly <NUM>. In at least some embodiments, the lead <NUM> is permanently coupled to the control module <NUM> (or a portion of the control module such as a connector <NUM>. ) In at least some embodiments, one or both of the lead <NUM> or catheter assembly <NUM> is detachable from the control module <NUM>.

The lead <NUM> extends from the control module <NUM>. <FIG> illustrates a distal portion <NUM> of the lead <NUM>. The lead <NUM> includes a lead body <NUM> (which has been made partially transparent in <FIG> to allow viewing of other elements of the lead) and multiple optical fibers <NUM> that extend along the lead and terminate in optical emitters <NUM>. Any suitable optical fibers <NUM> can be used. The terms "optical fiber" and "fiber optic" are used interchangeably herein and can be any suitable light guides or waveguides. As illustrated in <FIG>, an optical fiber <NUM> can include a core 128a and a cladding 128b. The core 128a of an optical fiber <NUM> can be made of, for example, glass, polymer (such as silicone), or any other suitable material. The cladding 128b can also be made of any suitable material including, but not limited to, polymers such as fluoropolymers. In at least some embodiments, the lead body <NUM>, or a portion of the lead body, may act as the cladding 128b.

In general, the cladding 128b of the optical fiber <NUM> has an index of refraction, n, (for at least one or more wavelengths of light that are to be transmitted along the optical fibers <NUM>) that is less than the index of refraction, ncore, of the core 128a (n<ncore). Light transmitted along the core 128a is reflected at the barrier between the core and cladding 128b if the angle of incidence, θ, is less than a critical angle (θc = sin-<NUM>(n/ncore)). In at least some embodiments, the optical fibers <NUM> have a critical angle of at least <NUM>, <NUM>, or <NUM> degrees. In at least some embodiments, the optical fibers <NUM> have an acceptance angle of at least <NUM> or <NUM> degrees.

Returning to <FIG>, the optical emitters <NUM> can be portions of the optical fibers <NUM> or can be attached to the optical fibers. For example, the optical emitters <NUM> can be portions of the optical fibers <NUM> from which the cladding 128b has been removed or can be made of the same or similar material to the core (or any other suitable material) with no cladding. Examples of optical emitters can be found in <CIT>.

In at least some embodiments, the optical emitters <NUM> are not covered by the lead body <NUM>. In other embodiments, the optical emitters <NUM> may be covered by the lead body <NUM> and, at least the portion covering the optical emitters, is made of material that is transparent or translucent to the light emitted from the optical emitters. In some embodiments, the lead body <NUM>, or one or more separate optical elements disposed on the optical emitters <NUM> or the optical emitter <NUM> itself, may include a lens, diffuser (for example, a defusing material or particles or a roughened surface of the optical emitter), polarizer, or other optical element at positions from which light can be emitted from the optical emitters.

Any suitable number of optical emitters <NUM> can be used including, but not limited to, one, two, three, four, five, six, eight, ten, twelve, or more. In at least some embodiments with multiple optical emitters <NUM>, the optical emitters <NUM> are disposed in a radial arrangement around the lead <NUM>, as illustrated in <FIG>. Any other suitable arrangement can also be used. In at least some embodiments, at last some of the optical emitters <NUM> may also or alternatively be arranged in a longitudinal arrangement along the length of the lead <NUM>. The radial or longitudinal (or both) arrangement of the optical emitters <NUM> can facilitate directional application of light to the tissue in which the lead <NUM> is implanted. In at least some embodiments, the optical emitters <NUM> have a length of at least <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, or <NUM> or longer. In at least some embodiments, the optical emitters <NUM> have a width of no more than <NUM>, <NUM>, <NUM>, or <NUM>.

The lead <NUM> also includes a lumen <NUM>, defined by the lead body <NUM>, that extends from the proximal portion of the lead to one or more openings <NUM> for flow of fluid, such as medications, water, or saline, from the catheter assembly <NUM> along the lead <NUM> and out the openings <NUM>. (In at least some embodiments, the openings <NUM> and lumen <NUM> can be used to draw out fluids, such as blood or other bodily fluids from the tissue.

In at least some embodiments, as illustrated in <FIG>, the lumen <NUM> is a central lumen with one or more additional lumens 146a defined in the lead body for passage of the optical fibers <NUM> and conductors <NUM>, such as wires or traces, for the imaging device <NUM>, as described below. In at least some embodiments, the lead body <NUM> can define individual additional lumens for each of the optical fibers <NUM> and conductors <NUM>. In other embodiments, a lumen can include two or more of the optical fibers <NUM> or conductors <NUM>. Yet other embodiments can include any other suitable arrangement of the lead body <NUM>, lumen <NUM>, optical fibers <NUM>, and conductors <NUM>.

In at least some embodiments, the lead body <NUM> includes a jacket 141a and a multi-lumen guide 141b. The jacket 141a and multi-lumen guide 141b can be made of any suitable material, such as, for example, polymeric materials such as silicone or polyurethane or the like or any combination thereof. The jacket 141a and multi-lumen guide 141b can be made of the same or different materials. In other embodiments, the lead body <NUM> only includes the multi-lumen guide 141b.

The distal portion <NUM> of the lead <NUM> optionally includes an imaging device <NUM>, such as a camera, to aid in implantation or observation of the treatment site. Conductors <NUM> extend along the lead <NUM> to provide power to the imaging device <NUM> and may conduct signals from the imaging device. In other embodiments, the imaging device <NUM> or lead <NUM> can include an antenna to transmit the signals from the imaging device to a viewing device (for example, a programming device) using any suitable transmission technique. In at least some embodiments, the proximal end of the lead <NUM> may include contacts <NUM> (<FIG>) that are attached to the conductors <NUM> and arranged to couple to the electrical contacts <NUM> of the control module <NUM>.

The imaging device <NUM> can be front-facing, side-facing, or any combination thereof. In at least some embodiments, the imaging device <NUM> has a field of view of at least <NUM>, <NUM>, <NUM>, <NUM>, or more degrees. In at least some embodiments, a lens <NUM> or other optical element(s) is disposed on the distal end of the lead <NUM>. One example of a suitable imaging device is a camera, such as the CameraCubeChip™ from OmniVision (Santa Clara, CA, USA). Any other suitable camera or other imaging device (for example, an ultrasound imaging device) can be used.

In at least some embodiments, an optical emitter or a light source (such as a laser diode, light emitting diode (LED), organic light emitting diode (OLED), or vertical cavity side-emitting laser (VCSEL)) may be disposed at the tip of the lead <NUM> near the imaging device <NUM> to emit light from through the tip (for example, through the lens <NUM>). Design considerations for this optical emitter or light source can be the same as those for the optical emitters <NUM> or light sources <NUM>.

<FIG> illustrates one embodiment of the control module <NUM> that includes a housing <NUM> with an electronic subassembly <NUM> and an optional power source <NUM> disposed in the housing. Preferably, the housing <NUM> is hermetically sealed.

The control module <NUM> also includes a connector <NUM> with electrical contacts <NUM>, one or more light sources <NUM>, a catheter coupling end <NUM> for coupling to the catheter assembly <NUM>, and a lead coupling end <NUM> for coupling to the lead <NUM>. In at least some embodiments, the lead <NUM> is permanently coupled to the connector <NUM>. In other embodiments, the lead <NUM> is arranged for removably coupling to the connector. The lead coupling end <NUM> includes a port <NUM> for receiving a portion of the lead <NUM>, as illustrated in <FIG>. If the lead <NUM> is removably coupleable, the lead <NUM> and lead coupling end <NUM> can include a coupling mechanism for coupling the proximal end of the lead to the lead coupling end. For example, the coupling mechanism can include a threaded opening in the lead coupling end <NUM> and a set screw that is screwed down against the lead <NUM>. Other coupling mechanism include twist couplings, screw-on couplings, push on couplings, or the like or any combination thereof.

In at least some embodiments, the connector <NUM> is part of the housing <NUM> and the electronic subassembly <NUM> and the optional power source <NUM> are coupled to the electrical contacts <NUM> and one or more light sources <NUM> using conductors (not shown), such as wires or traces.

In other embodiments, the connector <NUM> is permanently or removably attached to the housing <NUM>. In at least some embodiments, the connector <NUM> may be permanently attached to the lead <NUM> instead of the housing <NUM> of the control module <NUM>. In at least some embodiments, the connector <NUM> may be removably attached or attachable to the housing <NUM> using any suitable attachment mechanism. In at least some embodiments, when attached, the connector <NUM> is rotatably locked to the housing <NUM>.

In at least some embodiments, as illustrated in <FIG>, the housing <NUM> can include a feedthrough <NUM> with feedthrough pins 127a to couple the electronic subassembly <NUM> and the optional power source <NUM> within the housing to the electrical contacts <NUM> and one or more light sources <NUM> of the connector using conductors 127b, such as wires or traces.

Returning to <FIG>, the connector <NUM> of the control module <NUM> preferably includes one or more seals <NUM> within, or adjacent to, the catheter and lead coupling ends <NUM>, <NUM> to hinder or prevent inflow of fluid to the region of the connector <NUM> containing the electrical contacts <NUM> and one or more light sources <NUM>. If the lead <NUM> is permanently coupled to the connector <NUM>, then the conductors <NUM> of the lead can be attached to the electrical contacts <NUM>. If the lead <NUM> is removable from the connector <NUM>, the lead can include contacts <NUM> on the proximal end of the lead which are attached to the conductors <NUM> and arranged to contact the electrical contacts <NUM> when the lead is inserted into the port <NUM> of the connector <NUM>.

The control module <NUM> further defines a lumen <NUM> that extends from the catheter coupling end <NUM> to the lead coupling end <NUM>. The lumen <NUM> may be arranged to receive a proximal portion of the lead <NUM>. The lumen <NUM> may be arranged to allow for flow of fluid from the catheter assembly <NUM>, through the connector <NUM>, to the lumen <NUM> of the lead <NUM>. In at least some embodiments, at the catheter coupling end <NUM>, the lumen <NUM> can have a septum <NUM>. In other embodiments, the lumen <NUM> of the lead <NUM> can include the septum <NUM>.

The one or more light sources <NUM> can be, for example, laser diodes, light emitting diodes (LEDs), organic light emitting diodes (OLEDs), vertical cavity side-emitting lasers (VCSELs), lamps, or any other suitable light source. The one or more light sources <NUM> are electrically coupled to electronic subassembly <NUM> and power source <NUM>. Any number of light sources <NUM> can be used including, but not limited to, one, two, three, four, five, six, eight, ten, twelve, or more light sources. In at least some embodiments with multiple light sources <NUM>, the light sources are arranged radially within the connector <NUM>. Any other suitable arrangement of the light sources can be used.

In at least some embodiments, the number of light sources <NUM> is equal to the number of light emitters <NUM> (<FIG>) on the lead <NUM> with each light source coupled to one of the light emitters. In at least some embodiments, such an arrangement allows for independent operation of each of the light emitters <NUM> (<FIG>). In other embodiments, a light source <NUM> may be coupled to two or more of the light emitters <NUM> (<FIG>).

The light source(s) <NUM> can be selected to produce any suitable wavelength(s) of light including one or more wavelengths of visible, infrared, or ultraviolet light. In at least some embodiments, the light sources produce light in a wavelength range of <NUM> to <NUM> or in a range from <NUM> to <NUM> or in any combination thereof. In at least some embodiments, the light sources <NUM> produce the same wavelength(s) of light. In other embodiments, different light sources <NUM> may be used to produce different wavelengths of light. In at least some embodiments, each light emitter <NUM> (<FIG>) is coupled to two or more light sources <NUM> that produce different wavelengths of light. In at least some embodiments, the light source(s) <NUM> may include optical elements, such as filters, polarizers, lenses, collimators, or the like or any combination thereof to alter or modify the light emitted from the light source(s).

The one or more light sources <NUM> generate light based on programming of the control module <NUM> as implemented in the electronic subassembly <NUM>. In at least some embodiments, the light source(s) <NUM> can be individually programmed. In at least some embodiments, the light emitted by each of the individual light emitters <NUM> can be individually programmed.

In at least some embodiments, the light from the light source(s) <NUM> is directed using one or more lenses <NUM> (for example, a converging lens as illustrated in <FIG>) or other optics to one or more optical fibers <NUM> of the lead <NUM> (or optical fibers in the connector <NUM> that are configured to transfer the light to the optical fibers <NUM> of the lead <NUM>. ) In at least some embodiments, lens(es) <NUM> facilitate directing the light toward the optical fiber(s) <NUM> within the acceptance angle of the optical fiber(s). In at least some embodiments, the lens(es) <NUM> are coupled to the optical fiber(s) <NUM>. In at least some embodiments, multiple lenses may be used including a collimating lens and a converging lens.

If the lead <NUM> is permanently coupled to the connector <NUM>, the optical fiber(s) <NUM> are permanently aligned with the light source(s) <NUM>. If the lead <NUM> is removable from the connector <NUM>, the lead <NUM> and connector <NUM> may have a shape or include an arrangement (such as a pin or ridge and corresponding groove) that restricts coupling of the lead <NUM> and connector <NUM> to one or more specific alignments, thereby aligning the optical fiber(s) <NUM> with the light source(s) <NUM>.

<FIG> illustrates one embodiment of the catheter assembly <NUM> and <FIG> is a closer view of a distal connector <NUM> of the catheter assembly <NUM>. The catheter assembly <NUM> includes a catheter pump <NUM>, a tube <NUM> extending from the catheter pump, and the distal connector <NUM> coupled to the end of the tube. In at least some embodiments, the catheter pump <NUM> includes a pump and a reservoir to hold the medication or other fluid for pumping. In at least some embodiments, the catheter pump <NUM> can be decoupled from the tube <NUM>.

In at least some embodiments, the distal connector <NUM> defines an assembly lumen that extends from the tube <NUM> and includes a needle <NUM> that is arranged for insertion into the lumen <NUM> of the control module <NUM> (or the lumen <NUM> of the lead <NUM> if the lead <NUM> extends to the catheter coupling end <NUM> of the control module) when the catheter assembly <NUM> is coupled to the control module. In at least some embodiments, the lumen <NUM> of the control module <NUM> or the lumen <NUM> of the lead <NUM> includes a septum <NUM> that can be penetrated by the needle <NUM> for delivery of fluid. In at least some embodiments, the distal connector <NUM> includes sealing members <NUM> (for example, O-rings) around a portion of the needle <NUM> to prevent or hinder backflow of fluid into the distal connector <NUM>.

In at least some embodiments, the distal connector <NUM> and catheter coupling end <NUM> include a coupling mechanism <NUM> for coupling the distal connector to the catheter coupling end. For example, the coupling mechanism can include a threaded opening in the distal connector <NUM> and a set screw that is screwed down against the catheter coupling end. Other coupling mechanisms include twist couplings, screw-on couplings, push on couplings, or the like or any combination thereof.

In at least some embodiments, the photobiomodulation system <NUM> includes one or more of the following: a) the ability to administer medication or other fluids at the photobiomodulation site; b) real time visualization during or after implantation; or c) radial distribution and control of the emitted light.

<FIG> illustrates one embodiment of a delivery tool <NUM> for delivery of the lead <NUM> to a site for photobiomodulation. The delivery tool <NUM> includes an ergonomic hand grip arrangement having a first grip <NUM> and second grip <NUM> that is pivotably attached to the first grip <NUM> at a pivot point <NUM>. The delivery tool <NUM> also includes a barrel <NUM> extending from the first grip <NUM> and a scissor grip <NUM> extending out of the barrel. The scissor grip <NUM> has a first scissor arm 586a and a second scissor arm 586b that are pivotable relative to each other at a pivot point 586c, as illustrated in the close-up view of <FIG>. The second grip <NUM> is coupled to the scissor grip <NUM> through a pull rod or cable <NUM>. Moving the second grip <NUM> relative to the first grip <NUM> pushes or pulls the pull rod or cable <NUM> to open (<FIG>) or close (<FIG>) the scissor grip <NUM>. The facing interior surfaces 586d, 586e of the first and second scissor arms 586a, 586b each include a ridge or detent <NUM> that, when the scissor grip <NUM> is closed, bound the lead <NUM> to hold the lead within the scissor grip <NUM>.

In at least some embodiments, the delivery tool <NUM> also includes a vertical steering mechanism <NUM> that can be used to move the scissor grip <NUM>, and any lead <NUM> held by the scissor grip, up or down relative to the barrel <NUM>. The vertical steering mechanism <NUM> includes a vertical steering disc <NUM>, tabs 592a, 592b extending from the vertical steering disc for manipulation by the user, and, as illustrated in <FIG>, two steering cables 594a, 594b that are attached to the vertical steering disc or tabs and to opposing sides of the scissor grip <NUM>. The user moves manipulates the tabs 592a, 592b to pull on one of the steering cables 594a, 594b to move the scissor grip <NUM>, and any lead <NUM> held by the scissor grip, up or down relative to the barrel <NUM>. This vertical motion can facilitate more precise delivery or implantation of the lead <NUM> at the desired implantation site. In at least some embodiments, the imaging device <NUM> can be used to view the tissue in front or to the side of the lead <NUM> so that the user can guide the lead to the desired implantation site.

In at least some embodiments, as illustrated in <FIG>, each of the tabs (e.g., tab 592a) includes a cut <NUM> that the steering cable (e.g., steering cable 594a) can fit within. As illustrated in <FIG>, each of the steering cables 594a, 594b can include a knot or other element 594c that is larger than the cut <NUM> so that the steering cable is fixed to the tab 592a, 592b.

In at least some embodiments, the delivery tool <NUM> can provide for accurate and precise delivery of the lead <NUM> to the desired photobiomodulation site. This may be particularly important in regions, such as near the pancreas, where organ or tissue damage may have dangerous consequences.

Although the leads described above provide photobiomodulation, it will be understood that the leads, systems, arrangements, and methods can be modified to provide photobiomodulation and electrical stimulation by, for example, including components, such as electrodes or elements that provide current to the electrodes, for electrical stimulation.

Examples of electrical stimulation systems with leads that can be modified to include the photobiomodulation system <NUM> are found in, for example, <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>;<CIT>;<CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>;<CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; <CIT>; and <CIT>.

Figure <NUM> is a schematic overview of one embodiment of components of a photobiomodulation system <NUM> including an electronic subassembly <NUM> disposed within a control module <NUM> (for example, an implantable pulse generator). It will be understood that the photobiomodulation system can include more, fewer, or different components and can have a variety of different configurations including those configurations disclosed in the stimulator references cited herein.

In at least some embodiments, selected components (for example, a power source <NUM>, an antenna <NUM>, a receiver <NUM>, a processor <NUM>, and a memory <NUM>) of the photobiomodulation system can be positioned on one or more circuit boards or similar carriers within a sealed housing <NUM> (<FIG>) of a control module <NUM>. Any suitable processor <NUM> can be used and can be as simple as an electronic device that, for example, produces signals to direct or generate photobiomodulation at a regular interval or the processor can be capable of receiving and interpreting instructions from an external programming unit <NUM> that, for example, allows modification of photobiomodulation parameters or characteristics.

The processor <NUM> is coupled to one or more light sources <NUM> which provide light to one or more light emitters <NUM>, as described above. The processor <NUM> is generally included to control the timing and other characteristics of the photobiomodulation system. For example, the processor <NUM> can, if desired, control one or more of the timing, pulse frequency, amplitude, and duration of the photobiomodulation. In addition, the processor <NUM> can select one or more of the light sources <NUM> or light emitters <NUM> to provide photobiomodulation, if desired. In some embodiments, the processor <NUM> selects the frequency of the light for the photobiomodulation.

Any suitable memory <NUM> can be used. The memory <NUM> illustrates a type of computer-readable media, namely computer-readable storage media. Computer-readable storage media may include, but is not limited to, nonvolatile, non-transitory, removable, and non-removable media implemented in any method or technology for storage of information, such as computer readable instructions, data structures, program modules, or other data. Examples of computer-readable storage media include RAM, ROM, EEPROM, flash memory, or other memory technology, magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by a processor.

Any power source <NUM> can be used including, for example, a battery such as a primary battery or a rechargeable battery. Examples of other power sources include super capacitors, nuclear or atomic batteries, fuel cells, mechanical resonators, infrared collectors, flexural powered energy sources, thermally-powered energy sources, bioenergy power sources, bioelectric cells, osmotic pressure pumps, and the like. As another alternative, power can be supplied by an external power source through inductive coupling via an antenna <NUM> or a secondary antenna. The external power source can be in a device that is mounted on the skin of the user or in a unit that is provided near the user on a permanent or periodic basis. In at least some embodiments, if the power source <NUM> is a rechargeable battery, the battery may be recharged using the antenna <NUM> and a recharging unit <NUM>. In some embodiments, power can be provided to the power source for recharging by inductively coupling the power source <NUM> to the external recharging unit <NUM>.

In at least some embodiments, the processor <NUM> is coupled to a receiver <NUM> which, in turn, is coupled to an antenna <NUM>. This allows the processor <NUM> to receive instructions from an external source, such as a programming unit <NUM>, to, for example, program the photobiomodulation parameters and characteristics. The signals sent to the processor <NUM> via the antenna <NUM> and the receiver <NUM> can be used to modify or otherwise direct the operation of the photobiomodulation system. For example, the signals may be used to modify the characteristics of the photobiomodulation system such as modifying one or more of timing, pulse frequency, amplitude, and duration of the photobiomodulation. The signals may also direct the photobiomodulation system <NUM> to cease operation, to start operation, to start charging the battery, or to stop charging the battery. In other embodiments, the photobiomodulation system does not include the antenna <NUM> or receiver <NUM> and the processor <NUM> operates as initially programmed.

In at least some embodiments, the antenna <NUM> is capable of receiving signals (e.g., RF signals) from an external programming unit <NUM> (such as a clinician programmer or patient remote control or any other device) which can be programmed by a user, a clinician, or other individual. The programming unit <NUM> can be any unit that can provide information or instructions to the photobiomodulation system <NUM>. In at least some embodiments, the programming unit <NUM> can provide signals or information to the processor <NUM> via a wireless or wired connection. One example of a suitable programming unit is a clinician programmer or other computer operated by a clinician or other user to select, set, or program operational parameters for the photobiomodulation. Another example of the programming unit <NUM> is a remote control such as, for example, a device that is worn on the skin of the user or can be carried by the user and can have a form similar to a pager, cellular phone, or remote control, if desired. In at least some embodiments, a remote control used by a patient may have fewer options or capabilities for altering photobiomodulation parameters than a clinician programmer.

Claim 1:
A photobiomodulation system, comprising:
a control module (<NUM>) comprising
a housing (<NUM>),
an electronic subassembly (<NUM>) disposed in the housing,
a connector (<NUM>) configured to be coupled to the housing and defining a lead coupling end (<NUM>), a catheter coupling end (<NUM>), and a connector lumen (<NUM>) extending from the lead coupling end to the catheter coupling end, and
at least one light source (<NUM>) electrically coupled to the electronic subassembly and configured to produce light in response to signals from the electronic subassembly;
a lead (<NUM>) configured to be coupled to the control module and having a distal portion spaced apart from the control module, the lead comprising
a lead body (<NUM>) defining a lead lumen (<NUM>) that is configured for positioning in fluid communication with the connector lumen (<NUM>) of the connector of the control module, the lead body further defining at least one opening (<NUM>) along the distal portion of the lead and in fluid communication with the lead lumen,
a plurality of light emitters (<NUM>) arranged along the distal portion of the lead, and
a plurality of optical fibers (<NUM>) extending along the lead body and coupled to the light emitters and configured to receive light from the at least one light source (<NUM>) and deliver the light to the light emitters; and
a catheter assembly (<NUM>), comprising
a tube (<NUM>) coupleable to a catheter pump (<NUM>), and
a distal connector (<NUM>) attached to an end of the tube and configured to be coupled to the catheter coupling end (<NUM>) of the connector of the control module, the distal connector (<NUM>) comprising an assembly lumen extending from the tube and configured for fluid communication with the connector lumen (<NUM>) of the connector of the connector of the control module.