The use of laser therapy for treating certain medical conditions is gaining widespread acceptance within the medical community. Currently, both low level laser therapy (i.e., cold laser therapy) and high level laser therapy are used, for example, to provide temporary pain relief and to accelerate healing. Low level laser therapy typically involves treating the affected area with a low energy (class III) laser that induces little, if any, temperature elevation. In contrast, high level laser therapy typically utilizes a more powerful (class IV) therapeutic laser that is capable of providing deeper penetration and heating of the treatment area. An example of a high level laser that has proven effective for therapeutic treatment is the Biolase™ 10 Pain Therapy Laser sold by Biolase, Inc. of Irvine, Calif.
An example therapeutic device includes a garment configured to be worn on a user's body over a treatment area. The therapeutic device includes a plurality of therapeutic electromagnetic (EM) energy emitting devices, fixed to the garment at locations within the garment for irradiating the treatment area with EM energy when the garment is worn over the treatment area. A power supply is fixed to and within the garment. The power supply stores electrical charge and outputs electrical supply current from the stored electrical charge. A flexible graphite material is located within the garment and conducts the electrical supply current to the EM energy emitting devices to activate the EM energy emitting devices.
The flexible conductive material may alternatively comprise at least one of carbon impregnated rubber, carbon impregnated polymer, gold nanoparticles embedded in polyurethane, semiconducting nanowires, a non-woven, an electrically conductive fabric, carbon nanotube-coated silicone, carbon nanotube film, graphene sheets, and metal-nanowire mesh.
In some examples, the emitting devices are high level class IV lasers, or low level class III lasers, or light emitting diodes (LEDs). The garment may be a shoe insole. A controller may control the emitting devices to be activated in a sequence. The sequence may be in a longitudinal direction of the insole or radial direction of the insole. The sequence may yield a ring of light that travels radially outward from a center point or radially inward toward a center point. The power supply may include a piezoelectric device that is located in the insole and that generates, from compression and bending of the insole, electrical charge current for charging the power supply. A controller may direct the electrical supply current, from the power supply, to power the piezoelectric device to vibrate when the EM energy emitting devices are activated. The power supply may include a movement transducer that is located in the insole and that generates, from oscillatory movement of the insole, electrical charge current for charging the power supply. A temperature sensor in the insole may sense temperature, and a controller in the insole, may control activation of the EM emitting devices based on the sensed temperature. A compression sensor in the insole may sense compression force applied by a foot to the insole, and the controller in the insole may control activation of the EM emitting devices based on the sensed compression and count a number of steps taken with the shoe insole based on the sensed compression. The insole may be located in a shoe, and an external controller, outside the shoe, enables a user of the external controller to select treatment control parameters to be communicated to the internal controller, in the shoe, through a wireless communication link between the internal controller and the external controller. The garment might be a glove insert, a bandage, a garment worn on a shoulder, or a garment worn on a lower back.
As shown in
An array (plurality) 16 of therapeutic EM energy emitting devices 18 are attached to and embedded in the insole 12, for emitting (applying, irradiating) EM energy (light) to target tissue in the treatment area. The EM energy emitting devices 18 in this example are therapeutic lasers for emitting laser light, specifically high level (class IV) therapeutic lasers. Other EM energy emitting devices are low level (class III) lasers, light emitting diodes (LEDs) and other semiconductor energy sources. For example, the emitting devices could be provided by LEDs formed from the flexible graphite material, which may be configured as a flexible form of LED. The emitted EM energy may be in therapeutically effective visible or invisible wavelengths. Each laser 18 has an emitting end 18E located at the insole's top surface 12T to direct laser energy onto the sole of a foot. In this example, each emitting end 112 may be flush with the insole's top surface 12T. The emitting end 18E may alternatively be spaced below the top surface 12T, with an air gap between the emitting end and the user's foot. In other examples, the laser emitting ends 18E might be covered by a top protective layer of material that is transparent to the emitted electromagnetic energy, to provide a protective barrier between the lasers and the foot.
Configuration features of the laser array 16 may be customized to a particular type of foot problem (e.g., heel ulcer, inner arch wound) or a foot problem of a particular patient. The configuration features may include type of lasers used, density of lasers (i.e., number of lasers per given area), location of the laser array along the insole top surface 12T (e.g., under the heel, under the inner arch, distributed over the insole's entire top surface). Configuration features might further include the shape of the array 16, such as an array in which the lasers are arranged in concentric circles or (as in this case) arranged in columns 21 and rows 22. Configuration features might also include spacing between adjacent columns 21 (column spacing), spacing between adjacent rows 22 (row spacing), and an angle 0 between the columns 21 and rows 22. In the example of
An internal laser activation unit 24, within the shoe 14, provides electricity to activate the lasers 18. In this example, the activation unit 24 is secured to the insole 12 at the insole's heel section which supports the user's heel. The activation unit 24 (as shown in
The activation unit 24 includes an internal power supply 26 that supplies electrical power to the lasers 18. The internal power supply 26 may include an electrical charge storage device 27, such as a capacitor or rechargeable battery. The power supply may be recharged by electrical recharging current 28 from an external electrical source 30 (external to the shoe 14). Examples of the external electrical source are a cord plugged into a wall socket, a power adapter (e.g., 120VAC to 12VAC) plugged into a wall socket, a USB port (e.g., of a computer), a solar cell attached to an outside surface of a garment (such as the shoe) that converts ambient light to electricity, and a piezoelectric device (piezo strip) attached to a garment that converts body motion to electricity.
An electrical recharging link 32 extends from the external power source 30 to the internal power supply 26 to deliver the charging current 28. The recharging link 32 may be a cable. As shown in
The internal power supply 24 may include a power source internal to the shoe 14, so as to require less power or no power from the external power source 30. An example internal power source is a force transducer. The force transducer may be a piezoelectric device 36 (e.g., piezo strip) shown in
The piezo strip 36 may be powered by the activation unit 24 to vibrate during the laser treatment. This might enhance blood circulation during the treatment and also provide a tactile indication (notification) to the user that the EM energy is being applied. In this case, the piezo strip 36 charges the battery 27 from the foot's relatively slow moving pressure application (“slow” in that it occurs at the speed of taking a step) and later uses the charge to vibrate the foot tissue at relatively fast frequency of 5 Hz or greater.
Another example internal power source is a magnet-and-coil device 38 shown in
A controller 40, of the activation unit 24, includes an electrical circuit that controls conduction of power from the power supply 26 to the lasers 18. The controller 40 in this example includes a microprocessor 41 that executes software code instructions that are stored in a memory device 42 (data storage device), to perform functions of the controller. The memory device 42 may also store data (such as from sensors) that is collected by the controller 40 during treatment sessions.
The controller 40 controls laser activation parameters. The activation parameters might include a starting time of a laser treatment and the treatment's duration (e.g., in seconds). If the energy is emitted in pulses, the activation parameters may include pulse duration and pulse rate (e.g., number of pulses per unit time). The activation parameters may also include laser output power, which is controlled by controlling power (via wattage, voltage or current) supplied to each laser 18.
The controller 40 may power different lasers 18 at different locations of the foot with different activation parameters.
The controller 40 may power the lasers 18 to pulse simultaneously, or alternatively in a staggered but coordinated manner. For example, the controller 40 may activate lasers 18 in a sequence, for the light pulses to be emitted in a moving wave of light (corresponding to a string of activated lasers) that travels along the insole surface 12T. The moving wave may provide a massaging effect that promotes blood flow. The wave can travel longitudinally, by pulsing a first row 22 of lasers 18, then the next row, and then the next row, etc. The wave can travel laterally, by pulsing a first column 21 of lasers, then the next column, and then the next column, etc. The wave can comprise a ring of light that travels radially outward from a starting (center) point, by first pulsing a first ring of lasers centered on a starting point, then pulsing a second ring of lasers immediately surrounding the first laser, and then pulsing a third ring of lasers immediately surrounding first ring, etc. The wave may comprise a ring of light that travels radially inward from an outer ring of lasers toward a center point, by first pulsing the outer ring of lasers, then pulsing a second ring of lasers located within the first ring, and then pulsing a third ring located within the second ring. In the radially outward and radially inward examples, each successively activated ring may be concentric or non-concentric with the previously activated ring. A pulse may travel (orbit) along a circle or oval, by pulsing each laser of a ring of lasers in sequential order about the ring. The radius of the ring can gradually increase to produce an outward spiral, or gradually decrease to produce an inward spiral.
The controller 40 may include a temperature sensor 43 that measures (senses) temperature of the foot surface and outputs a temperature signal indicative of the temperature. The controller 40 may control the laser treatment to start when the foot surfaces is below a threshold temperature and to end when the foot surface is above a threshold temperature.
The controller 40 may include a compression sensor 44 (force sensor) that measures (senses) compression force applied by the foot to the insole and outputs a data signal indicative of the compression force. The controller 40 may use the compression (force) data to count and record the number of paces (steps) the patient has walked. The controller 40 may also use the compression data to control the treatment to occur only when the foot compresses (presses against) the insole 12. This avoids the treatment device 10 wasting electricity to power the lasers 18 when a foot is not even in the shoe 14. And even when a foot is in the shoe 14 and the patient is walking, this compression-dependent feature limits generation of the laser energy to when it will penetrate deepest into the foot tissue and be most therapeutically productive, and avoids electricity usage and heat generation at times when the laser energy might be less productive. With this compression-dependent feature, the insole 12 might not require an on/off switch. The piezo strip 36 described above for powering the lasers 18 may serve as the compression sensor 44.
An external controller 50, outside the shoe 14, may send control data, such as laser activation parameters (e.g., start time, pulse duration) to the internal controller 40. The external controller 50 may be a personal computer with a software application configured to enable a medical practitioner (user of the external controller) to select laser activation parameters to be communicated to the internal controller 40. The external controller 50 may also receive feedback data from the internal controller 40. The feedback data may include battery charge, battery capacity, historic usage information such as when the treatments occurred, their durations, sensed foot temperature (from temperature sensor), and number of steps walked (from force sensor).
A data communication link 51 conducts communications between the external controller 50 and the internal controller 40. The communication link 51 may be a wired data communication line, such as the recharging electrical line 32 extending from the insole 12 to outside the shoe 14. Alternatively, the data communication link 51 may be a short range wireless communication link, such as Bluetooth.
An electrical supply line 52 conducts electricity (electrical power) from the activation unit 24, under control of the controller 40, to the lasers 18. In this example, the supply line 52 is a trace pattern (
The trace pattern 52 in this example is patterned from a sheet of flexible graphite material and included as an inner layer within the shoe insole 12. The flexible graphite trace layer 52 may dissipate heat generated from the lasers 18 to protect the user's foot from discomfort or thermal damage. The supply line 52 is sandwiched between upper and lower insulating layers 54U, 54L.
A heat expelling component 53 may conduct heat from inside the show 14 to outside the shoe 14. The heat expelling component 53 is of heat conducting material, such as a metal strip or graphite material. The heat expelling material 53 may be an extension of the graphite material that forms the electrical supply line 52 to the lasers 18, and may extend from the supply line 52 inside the shoe 14 to a location outside of the shoe 14. If the footwear is a sandal or sock, which enables ventilating air to reach the foot, then a heat expelling material may be less beneficial than if the footwear is a shoe.
In this example, the upper layer 152U provides a power plane for the lasers 18, and the lower layer 152L provides a ground plane. The lasers 18 are inset through holes 155 in the upper and lower insulating layers 154U, 154L and upper supply line layer 152U, and contact the upper and lower conductive layers 152U, 152L. The battery 126 is tightly held in a hole 155 in the lower insulating layer 154L, and its terminals contract the upper and lower supply line layers 152U, 152L. As with the supply line 52 of the first treatment device 10, the supply line layers 152U, 152L of the second device 110 may dissipate heat generated from the lasers 18 to protect the patient's foot from discomfort or thermal damage. Further protection from heat emitted by the lasers 18 may be provided by the insulating layers 154A, 154B.
Each laser 18 includes power and ground terminals 171, 172 that are respectively positioned to provide contact with the supply line layers 152U, 152L. In this example, the laser's power terminal 171 is located at the side of the laser 18 to connect to the power plane 152U, and the ground terminal 172 is located at the bottom of the laser 210 to connect to the ground plane 152L.
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The example laser treatment devices described above enable therapeutic advantages of a high level laser to be implemented in a treatment schedule over an extended period, for example to accelerate healing of an injury, to provide pain relief, and/or to kill fungus or bacteria. Despite the high power requirements of a high level laser, the configurations described above reduce the bulkiness that would otherwise be required.
While the disclosure has been described in detail and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that various changes and modifications can be made therein without departing from the spirit and scope of the embodiments. Thus, it is intended that the present disclosure cover the modifications and variations of this disclosure provided they come within the scope of the appended claims and their equivalents. For example, other embodiments could include therapeutic lasers and a flexible graphite interface within other types of garments, such as a compression arm or leg sleeve, a vest, a sock, an adhesive patch, etc. In another example, a high power (class IV) laser source could be utilized with a plurality of optical fibers in a bundle that terminate into optical lens that can be selected so the electromagnetic energy pattern penetrates deeply (low divergence angle) for certain conditions such as acute shoulder injuries and spreads widely for other conditions like nail fungus or acne.
The components and procedures described above provide examples of elements recited in the claims. They also provide examples of how a person of ordinary skill in the art can make and use the claimed invention. They are described here to provide enablement and best mode without imposing limitations that are not recited in the claims. In some instances in the above description, a term is followed by a substantially equivalent term enclosed in parentheses.
This application claims priority to U.S. Provisional Patent No. 61/808886, filed Apr. 5, 2013, hereby incorporated herein by reference.
Number | Date | Country | |
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61808886 | Apr 2013 | US |