Systems and Methods for the Automated Delivery of Photobiomodulation Therapy to a Patient
Systems and methods for treating neuropathic pain by using a photobiomodulation device in a handheld manner. A robotic arm is attached to a light emitting device and controlled, using a visual display, to automatically position the light emitting device over areas to be treated on the patient's body. The automated light delivery process allows a patient to treat large portions of her body in a handsfree manner.
The present application is a continuation application of U.S. patent application Ser. No. 16/586,250, entitled “Systems and Methods for the Automated Delivery of Photobiomodulation Therapy to a Patient” and filed on Sep. 27, 2019, which is a continuation application of U.S. patent application Ser. No. 16/248,692, entitled “Systems and Methods for Providing Cold Laser Therapy to a Patient in a Hands-Free Manner”, filed on Jan. 15, 2019, and issued as U.S. Pat. No. 10,463,874 on Nov. 5, 2019. The above referenced applications are all hereby incorporated by reference into this application in their entirety.
FIELD OF THE INVENTIONThe present application relates generally to holder and positioning devices to enable an effective delivery of cold laser therapy and, more specifically, to devices capable of being secured to a patient's skin and of removably receiving, and holding in place, a cold laser wand so that a patient may use the device in a hands-free manner.
BACKGROUNDCold laser devices are low-intensity laser systems, typically comprising a hand-held wand and a generator either separate or integrated into a single housing, that generate low levels of light. Exposing a patient's skin to low levels of light achieves numerous health benefits. During this conventional procedure, the handheld wand of a cold laser device is positioned proximate the patient's skin and different wavelengths and outputs of low-level light are applied directly to a targeted area. When the patient's tissue absorbs the light, red and near-infrared light cause a reaction, damaged cells respond with a physiological reaction that promotes regeneration, and healing occurs. Skin tissue is commonly treated with wavelengths between 600 and 700 nanometers (nm) and, for deeper penetration, with wavelengths between 780 and 950 nm. These devices are also referred to as low-level laser therapy, low-power laser therapy, soft laser biostimulation, and photobiomodulation, collectively referred to as cold laser therapy devices.
While potentially therapeutically effective, existing cold laser systems with handheld wands require a therapist or patient to hold the device at a particular range from the area of skin requiring treatment for many minutes at a time. For example, the handheld wand may be required to be held just above a treatment site for anywhere from 15 seconds to 1 hour. Therapists and patients find it difficult to hold the device in place for such long periods of time. This problem is particularly exacerbated in patients with severe pain or chronic neuropathy, in situations where the device needs to be proximate to the skin, but not touching the skin due to pain, and in situations where the patient is attempting to self-treat but the location of the pain is difficult to reach.
It is therefore desirable to have a system for transforming a conventionally handheld treatment method into a hands-free treatment method. It is further desirable to have a way of securing a cold laser wand to any portion of the patient's body, thereby enabling hands-free treatment in difficult to reach locations. It is further desirable to have a securing system that can accommodate different size wands to enable a clinician to use different therapeutic modalities. It is also desirable to have a securing system that can adjust the distance of the wand head from the patient's skin to allow for a range of different exposure distances and to better capture and direct light from a device to the patient's skin. Additionally, because many chronic neuropathy patients suffer from sensitivity to touch (allodynia), it would be beneficial to have a system that would alter the distance of the device from the patient's skin while not unduly exposing the patient's skin to abrasive or undesirable materials.
SUMMARY OF THE INVENTIONThe present specification discloses a method of treating peripheral neuropathic pain using a handheld cold laser device comprising: acquiring the handheld cold laser device, wherein the handheld cold laser device comprises a light emission surface and a body attached to, but separate from, the light emission surface; attaching a patient attachment surface to a portion of a patient's body, wherein the patient attachment surface comprises a light emission surface receiver; attaching the light emission surface to the light emission surface receiver, wherein the light emission surface receiver comprises a hollow cavity enclosed by a first wall, wherein the first wall has a periphery, and wherein an external surface of the light emission surface is positioned inside the periphery; adjusting a position of a support member having a first end and a second end, wherein the first end of the support member is attached to at least one of the light emission surface receiver or the patient attachment surface, wherein the second end of the support member is in physical contact with the body of the handheld cold laser device, and wherein the second end of the support member is adjusted such that the light emission surface is maintained in a position parallel to the patient's skin in a hands-free manner; and activating the handheld cold laser device to transmit light from the light emission surface through the light emission surface receiver and to the patient's body.
Optionally, the method further comprises adjusting the periphery of the light emission surface receiver to achieve a friction fit with the external surface of the light emission surface.
Optionally, adjusting the position of the support member comprises rotating the support member, wherein the support member is hinged at one end to at least one of the light emission surface receiver or the patient attachment surface. Optionally, the support member comprises a curved portion at a second end to receive the body of the cold laser device.
Optionally, an internal surface of the first wall comprises a reflective material wherein the reflective material is positioned to cause light emitted from the light emission surface and impinging on the internal surface of the first wall to be directed toward the patient's skin. Optionally, at least 20% of the internal surface of the first wall comprises the reflective material. Optionally, at least 50% of the internal surface of the first wall comprises the reflective material. Optionally, at least 70% of the internal surface of the first wall comprises the reflective material.
Optionally, the wall of the light emission surface receiver has a plurality of holes to release heat generated from light emitted by the light emission surface.
Optionally, the wall of the light emission surface is porous.
Optionally, the wall of the light emission surface receiver is vertically adjustable to thereby modify a distance between the light emission surface and the patient's skin.
Optionally, the light emission surface receiver is detachable from the patient attachment surface.
Optionally, the light emission surface receiver is attached to the patient attachment surface using at least one of a friction fit, Velcro, snaps, a sewed connection, or glue.
Optionally, the support member comprises a height adjustment mechanism and adjusting the position of the support member comprises modifying the height adjustment mechanism.
Optionally, the support member comprises a telescopic height adjustment mechanism and adjusting the position of the support member comprises turning a dial to cause one portion of the support member to move relative to a second portion of the support member.
Optionally, the light emission surface receiver comprises a second wall that encloses the first wall, wherein an interior surface of the second wall is attached to an exterior surface of the first wall through a member and wherein the second wall is configured to permit heat to flow away from the patient's body. Optionally, the first wall has a first length and the second wall has a second length, wherein the first length is less than the second length, and wherein the second wall comprises a plurality of openings.
Optionally, the method further comprises deactivating the handheld cold laser device to turn off light from the light emission surface after a period of time, wherein the period of time is sufficient to at least partially treat the peripheral neuropathic pain.
Optionally, the light emission surface has a first geometric shape and the light emission receiver has a second geometric shape, wherein the second geometric shape is similar to the first geometric shape but of a different size. Optionally, the first geometric shape is at least one of rectangular, circular, oval, trapezoidal, triangular, polygonal, or conical.
The aforementioned and other embodiments of the present specification shall be described in greater depth in the drawings and detailed description provided below.
These and other features and advantages of the present specification will be further appreciated, as they become better understood by reference to the following detailed description when considered in connection with the accompanying drawings:
The present invention may be used to treat, in a substantially hands-free manner, numerous conditions, including ligament sprains, muscle strains, tendonitis, bursitis, neck pain, back pain, knee pain, muscle spasms, inflammation, swelling, ulcerations, rheumatoid arthritis, autoimmune diseases, peripheral neuropathy, fibromyalgia, carpal tunnel syndrome, acne, psoriasis, burns, vitiligo, edema, dermatitis, rashes, wounds related to diabetes, and diabetic neuropathy.
The present specification is directed towards multiple embodiments. The following disclosure is provided in order to enable a person having ordinary skill in the art to practice the invention. Language used in this specification should not be interpreted as a general disavowal of any one specific embodiment or used to limit the claims beyond the meaning of the terms used therein. The general principles defined herein may be applied to other embodiments and applications without departing from the spirit and scope of the invention. Also, the terminology and phraseology used is for the purpose of describing exemplary embodiments and should not be considered limiting. Thus, the present invention is to be accorded the widest scope encompassing numerous alternatives, modifications and equivalents consistent with the principles and features disclosed. For purpose of clarity, details relating to technical material that is known in the technical fields related to the invention have not been described in detail so as not to unnecessarily obscure the present invention.
In the description and claims of the application, each of the words “comprise” “include” and “have”, and forms thereof, are not necessarily limited to members in a list with which the words may be associated. It should be noted herein that any feature or component described in association with a specific embodiment may be used and implemented with any other embodiment unless clearly indicated otherwise.
As used herein, the indefinite articles “a” and “an” mean “at least one” or “one or more” unless the context clearly dictates otherwise.
As used herein, the term “cold laser wand” refers to a handheld device that emits light, and preferably one or more beams of coherent monochromatic light by the stimulated emission of photons from excited atoms, with wavelengths between 600 and 950 nanometers (nm).
As used herein, the term “hands-free manner” refers to the positioning and use of a cold laser device such that the preferred positioning of the device is maintained without requiring a person to hold the device.
While potentially therapeutically effective, existing cold laser systems with handheld wands require a therapist or patient to hold the device at a particular range from the area of skin requiring treatment for many minutes at a time. For example, the handheld wand may be required to be held just above a treatment site for anywhere from 15 seconds to 1 hour. Therapists and patients find it difficult to hold the device in place for such long periods of time. This problem is particularly exacerbated in patients with severe pain or chronic neuropathy, in situations where the device needs to be proximate to the skin, but not touching the skin due to pain, and in situations where the patient is attempting to self-treat but the location of the pain is difficult to reach.
It is therefore desirable to have a system for transforming a conventionally handheld treatment method into a hands-free treatment method. It is further desirable to have a way of securing a cold laser wand to any portion of the patient's body, thereby enabling hands-free treatment in difficult to reach locations. It is further desirable to have a securing system that can accommodate different size wands to enable a clinician to use different therapeutic modalities. It is also desirable to have a securing system that can adjust the distance of the wand head from the patient's skin to allow for a range of different exposure distances and to better capture and direct light from a device to the patient's skin.
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Separate from the wand 115 is a holder system comprising a light emission surface receiver 110 connected, using a connection means 105, to an attachment surface 103. The light emission surface receiver 110 may have a fixed circumference, size, or periphery configured to securely, and internally, receive the periphery 135 of the light emission surface 130. The light emission surface receiver 110 comprises a hollow cavity, defined by a peripheral wall 140. The internal surface of light emission surface receiver 110 may be securely attached to the external periphery 135 of the light emission surface 130 through a friction fit, snap fit, the mating of a groove with a protrusion, Velcro, snaps, or other connection mechanism, the components of which may be located on either the external periphery of the light emission surface 130 and/or the internal periphery of the light emission surface receiver 110.
Alternatively, the light emission surface receiver 110 may have an adjustable circumference, size, or periphery configured to be adjusted in order to adapt to the size of the periphery of the light emission surface 130 and thereby securely receive the periphery 135. The circumference, size or periphery may be adjusted by having a telescoping structure that, when pulled upwards, releases smaller and smaller peripheries until the right size is achieved, as shown in
In some embodiments, internal surface of the wall of receiver 110 comprises a reflective material that is positioned to cause light emitted from the light emission surface 130 and impinging on the internal surface of the wall of receiver 110 to be directed toward the patient's skin. In some embodiments, at least 5% of the internal surface of the wall comprises the reflective material. In some embodiments, at least 50% of the internal surface of the wall comprises the reflective material. In some embodiments, at least 95% of the internal surface of the wall comprises the reflective material. The internal surface of the wall may comprise reflective material on 1% to 99%, or any increment therein, of the surface area.
The light emission surface 130 and corresponding receiver 110 may adopt a plurality of different shapes.
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In embodiments, light emission surface receiver 310a is connected, using a connection means, to an attachment surface. The attachment surface may be used to attach holder comprising receiver 310a that fixedly holds light emission surface 230a over a patient's skin surface. The light emission surface receiver 310a may have a fixed circumference, size, or periphery configured to securely receive the periphery 235a of the light emission surface 230a. Light emission surface receiver 310a comprises a hollow cavity, defined by a peripheral wall. The internal surface of light emission surface receiver 310a may be securely attached to the external periphery of the light emission surface 230a through a friction fit, snap fit, the mating of a groove with a protrusion, Velcro, snaps, or other connection mechanism, the components of which may be located on either the external periphery of the light emission surface 230a or the internal periphery of light emission surface receiver 310a.
In some embodiments, in accordance with the present specification, wall of light emission surface receiver 110, 310a, or any other exemplary embodiment described herein, is configured to be porous in order to allow heat generated by light emitted from light emission surface 130 (230a, or any other similar light emission surface described herein) to escape.
In another embodiment, illustrated in
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In embodiments, light emission surface receiver 310b is connected, using a connection means, to an attachment surface. The attachment surface may be used to attach holder that fixedly holds light emission surface 230a over a patient's skin surface. The light emission surface receiver 310b may have a fixed circumference, size, or periphery configured to securely receive the periphery 235b of the light emission surface 230b. Light emission surface receiver 310b comprises a hollow cavity, defined by a peripheral wall. The internal surface of light emission surface receiver 310b may be securely attached to the external periphery of the light emission surface 230b through a friction fit, snap fit, the mating of a groove with a protrusion, Velcro, snaps, or other connection mechanism, the components of which may be located on either the external periphery of the light emission surface 230b or the internal periphery of light emission surface receiver 310b.
Referring simultaneously to
Light emission surface receiver 310c is connected, using a connection means, to an attachment surface. The attachment surface may be used to attach holder that fixedly holds light emission surface 230c over a patient's skin surface. The light emission surface receiver 310c may have a fixed circumference, size, or periphery configured to securely receive the periphery 235c of the light emission surface 230c. Light emission surface receiver 310c comprises a hollow cavity, defined by a peripheral wall. The external surface of light emission surface receiver 310c may be securely attached to the internal periphery of the light emission surface periphery 235c through a friction fit, snap fit, the mating of a groove with a protrusion, Velcro, snaps, or other connection mechanism, the components of which may be located on either the external periphery of the light emission surface receiver 310c or the internal surface of the periphery of light emission surface 235c.
In the various embodiments of the present specification, internal surfaces of the light emission surface receiver may be covered by a reflective material in areas other than the light emitting diodes or optical fiber emission points. The reflective surface is useful to reflect the light and therefore optimize its effect on a target.
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In embodiments, light emission surface 230e is positioned at a flat edge of cylindrical body 220e and has a diameter that is less than a diameter of the flat circular end of elongated cylindrical body of wand 215e. Further, wand 215c comprises a corresponding light emission surface receiver 310c that is circular with a circumference to match that of light emission surface 230c such that it may either friction fit around or within external periphery 235e. All other features described with respect to other embodiments may equally apply to this geometric configuration.
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In embodiments, light emission surface receiver 510 may be fixedly or removably attached to a patient attachment surface 503. The patient attachment surface 503 may comprise Lycra, spandex, plastic, straps, brace, sleeve, or any flexible material that may be contoured to securely and comfortably attach to a patient. Light emission surface receiver 510 may be attached to patient attachment surface 503 using any connection mechanism, including sewing, gluing, Velcro, snaps, zippers, a friction fit, or the mating of a groove with a protrusion, the components of which may be located on either patient attachment surface 503 or light emission surface receiver 510.
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In some embodiments, robotic arm 968 comprises multiple components such as support members 964 that are hinged at one or more locations 966 to control the movement and position of device 962. Once the pain locations are selected, controller 970 translates the selected location of the pain into a plurality of arm 968 positions based on one or more parameters. For example, the selected location of the pain is translated into a plurality of arm 968 positions based on the location of associated nerves, tissues, or other organs that have to be irradiated with light to treat the identified loci of pain.
In some cases, location of the associated nerves, tissues, or other organs may be different from the locations identified in visual display 1072 over the patient's anatomy. In one example, the patient experiencing pain in the thigh may need light therapy in accordance with the present specification, over the lower back. In this example, the visual display and the patient indicate that the pain exists in the thigh. Controller 970 may translate this information to plurality of arm 968 positions that irradiate light over the lower back. A database, table, or memory structure is preferably stored in the controller or remotely accessible by the controller and comprises a plurality of translation data, wherein a selection of a particular anatomical location as having pain, tingling, numb, or other undesired sensation may be translated into a plurality of different anatomical locations requiring illumination by the light emitting device.
Referring to
Once the patient's body has been scanned, associated with pixel and 3 dimensional positioning information, the mobile phone or tablet device may be removed from the arm and the light emitting device may be put in its place. The controller, via an integrated display or a remotely connected display on a tablet or phone, will extract a silhouette or some other abstraction of the patient's body (from the captured images) and display it 1106. The patient or physician will then select areas of the body which are in pain and the controller will therefore receive a selection of pixels as being indicative of loci of pain 1108. The controller is configured to translate the identified pixels into anatomical locations, based on the calibration and prior mapping, and further configured to translate those first identified anatomical locations into a second set of anatomical locations, different from the first, based on a translation step as described above 1110. With the selected first set of identified anatomical locations and the translated second set of identified anatomical locations established, a full list of associated pixel locations are determined 1112 and the associated three dimensional configurations of the robotic arm are determined 1114. The system is then initiated to move the arm based on the determined three dimensional configurations 1116.
Controller 970 may be further configured to move the arm in accordance with a predefined set of time periods, based on a required time for irradiation for a given anatomical location. In some cases, the required time for irradiation may be 5 seconds, while at another location the time required may be 10 seconds. Controller 970 may adjust the time of irradiation at each position of arm 968, based on the anatomical location to be illuminated. For example, arm 968 is controlled by controller 970 to move device 962 over different pain locations and irradiate light for similar or different times at each location.
In yet another example, controller 970 translates the selected location of the pain into a plurality of arm 968 positions based on a preferred sequence for irradiating multiple locations over the anatomy of the patient in order to treat pain in a minimal amount of time. For example, suppose patient has identified 3 areas of pain on his back. The controller has translated those three areas of pain into a plurality of anatomical locations requiring illumination, resulting in a total of six areas requiring illumination. The controller then executes a plurality of programmatic instructions to determine the optimum illumination process for delivering a requisite therapeutic dose to the six areas. Such a determination comprises: a) determining a time range for illuminating each of the target locations, b) grouping the target locations based on their proximity to each other (i.e. if two areas are within a predefined distance, such as the width or length of the light emission device, they are grouped together as a single illumination point) and based on each of their determined time ranges (if two areas require different illumination times, they may be treated as different illumination points), and c) determining a sequence of illuminating each of the determined illumination points, which is preferably done serially in one direction along a length of the patient or done based on any medical requirement for one anatomical location to be illuminated prior to, or after, another anatomical location.
In another example, controller 970 translates the selected location of the pain into a plurality of arm 968 positions based on an optimal angle from which the light emitted on a patient's vertical or horizontal body would provide suitable treatment. In one example, a patient experiencing pain on a side of quadriceps muscle of the thigh could lie flat on a table while the controller 970 positions arm 968 at an angle such that device 962 is parallel to a side surface of the thigh.
In some embodiments, device 962 comprises an array of lights where each light, or subset of lights, in the array may be separately controlled by controller 970 to emit for different times or in a sequence, based on an identified position and loci of pain. This may be particularly important where the light emission device has an area sufficient to cover multiple anatomical locations but where each of those anatomical locations require different illumination times, such as anatomical location 1 requiring a longer period of illumination than anatomical location 2. In such a situation, the lights (a first subset of the light array in the light emission device) positioned over anatomical location 2 may be turned off after a first period while the lights (a second subset of the light array in the light emission device) positioned over anatomical location 1 may be kept on for the entirety of a second period.
While the exemplary embodiments of the present invention are described and illustrated herein, it will be appreciated that they are merely illustrative. It will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from or offending the spirit and scope of the invention.
Claims
1. A method of treating peripheral neuropathic pain of a patient using an automated photobiomodulation delivery system comprising:
- providing the photobiomodulation delivery system, wherein the photobiomodulation delivery system comprises: a light emitting device; a robotic member attached to the light emitting device; a visual display configured to acquire and display a depiction of the patient's anatomy, wherein the visual display is further configured to receive an indication of the patient's anatomy to be treated and generate data representative of said anatomy to be treated; and a controller configured to receive the data representative of the anatomy to be treated and, based on the data, control a positioning of the light emitting device using the robotic member;
- receiving the indication of the patient's anatomy to be treated via the visual display; and
- positioning the light emitting device to deliver light to the patient's anatomy to be treated by moving the robotic member using the controller based on the indication of the patient's anatomy to be treated.
2. The method of claim 1, wherein the controller is configured to translate data representative of the anatomy to be treated into a plurality of positions of the robotic member.
3. The method of claim 2, further comprising a data structure having a plurality of translation data, wherein the controller is configured to translate data representative of the anatomy to be treated into the plurality of positions of the robotic member using the plurality of translation data.
4. The method of claim 1, wherein the controller is configured to translate data representative of the anatomy to be treated into a plurality of positions of the robotic member and wherein the plurality of positions of the robotic member would result in the irradiation of nerves or tissues associated with locations of the anatomy to be treated.
5. The method of claim 4, wherein locations of said nerves or tissues are different from the locations of the anatomy to be treated.
6. The method of claim 1, further comprising calibrating the robotic member.
7. The method of claim 6, wherein calibrating the robotic member comprises moving the visual display over the patient's entire body and causing the controller to associate discernable anatomical landmarks with three dimensional location information.
8. The method of claim 7, wherein the anatomical landmarks comprise at least one of the patient's shoulders, hands, legs, feet, armpits, or head.
9. The method of claim 7, wherein the three dimensional location information is derived from at least one of an accelerometer sensor, a magnetometer sensor, or a gyroscope sensor.
10. The method of claim 9, wherein the accelerometer sensor, the magnetometer sensor, or the gyroscope sensor is positioned on a distal end of the robotic member.
11. The method of claim 7, wherein the anatomical landmarks are associated with pixels.
12. The method of claim 1, further comprising associating specific visual landmarks with particular positions on the patient's body and associated accelerometer, gyroscope, or magnetometer data.
13. The method of claim 1, wherein the controller is configured to move the robotic member in accordance with a predefined set of time periods.
14. The method of claim 1, wherein the controller is further configured to determine a sequence of illuminating a series of anatomical locations based on the anatomy of the patient.
15. The method of claim 1, wherein the controller is further configured to determine a time range for illuminating each location of the patient's anatomy to be treated.
16. The method of claim 1, wherein the controller is further configured to group areas of the patient's anatomy to be treated based on their proximity to each other.
17. The method of claim 1, wherein the controller is further configured to determine a sequence of illuminating each location of the patient's anatomy to be treated based on a medical requirement for one anatomical location to be illuminated prior to, or after, another anatomical location.
18. The method of claim 1, wherein the controller is further configured to determine an optimal angle to emit light on the patient's anatomy to be treated.
19. The method of claim 1, wherein the light emitting device comprises a plurality of lights wherein each light in the plurality of lights is configured to be separately controlled by the controller.
20. The method of claim 19, wherein the controller is configured to activate a subset of the plurality of lights.
Type: Application
Filed: Sep 28, 2020
Publication Date: Jan 14, 2021
Inventors: Nadia Ansari (Tustin, CA), Kamran Ansari (Tustin, CA)
Application Number: 17/034,506