Apparatus and method for treatment of foot and nail diseases
09694200 ยท 2017-07-04
Inventors
Cpc classification
A61N2005/0626
HUMAN NECESSITIES
A61M37/0092
HUMAN NECESSITIES
A61N5/062
HUMAN NECESSITIES
A61K33/14
HUMAN NECESSITIES
A61M2037/0007
HUMAN NECESSITIES
A61N1/40
HUMAN NECESSITIES
A61M2230/005
HUMAN NECESSITIES
A61N5/0624
HUMAN NECESSITIES
International classification
A61F7/00
HUMAN NECESSITIES
A61K33/14
HUMAN NECESSITIES
A61M37/00
HUMAN NECESSITIES
A61M35/00
HUMAN NECESSITIES
Abstract
A method and apparatus for treatment of fungal infections and/or other foot skin disorders, comprises a shoe-type housing having a substantially hollow interior forming a treatment chamber, a supporting platform disposed within the hollow chamber; so that a foot of a patient positioned within the treatment chamber is supported by the platform, so that nails are disposed at the lower level of the front part of the chamber, whereas the heel of the foot is being elevated a rear part thereof. A delivery and control assembly for the aqueous solution is provided. At least one light delivery arrangement is disposed within or in the vicinity of the treatment chamber.
Claims
1. A method for treatment of one or more skin medical conditions of a limb of a patient, the skin medical conditions including a fungal infection, the method comprising: inserting the limb of said patient within a hollow treatment chamber formed within a shoe shaped housing, the shoe shaped housing having at least one light source configured to emit skin treatment light energy, a circulation assembly configured to circulate a skin treatment aqueous solution, one or more sensors, and a power and control unit to control the circulation assembly and the at least one light source; detecting one or more skin parameters of the limb with the one or more sensors, the skin parameters selected from the group consisting of skin melanin concentration, skin hemoglobin concentration, and skin water content; controlling with the power and control unit: a treatment protocol for the limb based on said one or more skin parameters detected by said one or more sensors, the treatment protocol including a duration of exposure of the limb to said aqueous solution and an amount of said skin treatment energy for irradiating the limb; and an amount of the skin treatment aqueous solution in the treatment chamber to partially or fully submerge the limb; submerging the limb or a portion thereof in said skin treatment aqueous solution by delivering the amount of skin treatment aqueous solution to the treatment chamber, with the circulation assembly; circulating the amount of the skin treatment aqueous solution within the treatment chamber with the circulation assembly for the duration of exposure; and irradiating said limb within the treatment chamber with the amount of skin treatment energy at a wavelength absorbed by the skin of the limb, with the at least one light source.
2. The method of claim 1, wherein the skin treatment aqueous solution is capable of eliminating skin pathogens.
3. The method of claim 1, wherein: the treatment chamber extends between front and rear areas of the housing; the housing further includes a supporting platform disposed within the hollow chamber with a top surface of the platform is positioned at an acute angle relative to a bottom of the apparatus; the treatment chamber is supported by the platform and angled having a front part at a lower level than a rear part thereof than a rear part of the treatment chamber; and wherein said step of inserting the limb of said patient comprises inserting a foot of a patient within said treatment chamber with nails of the foot disposed in said front part of said treatment chamber are lower than a heel of the foot disposed in said rear part of the treatment chamber.
4. The method of claim 3, wherein a top surface of the supporting platform is formed from a resilient material and a gel layer is provided below the resilient top surface of the platform, the method further comprising the step of adapting said resilient material to a specific shape of said foot of said patient.
5. The method of claim 3, wherein the treatment chamber includes an inner area covered by flexible material transparent to light radiation, the flexible material forming a disposable envelope positioned within the treatment chamber, and wherein said inserting said foot of said patient within said treatment chamber comprises covering said foot with said flexible material.
6. The method of claim 3, wherein said apparatus further comprises a cooling arrangement formed within the interior of the supporting platform and a solution reservoir, wherein the cooling arrangement and the interior of the treatment chamber form part of said circulation assembly, and said method further comprising the step circulating a cooling fluid within the treatment chamber thereby reducing a temperature of the aqueous solution.
7. The method of claim 6, wherein the apparatus further comprises a detecting arrangement selected from the group consisting of photoelements, photoresistors and photodiodes, and wherein the method further comprises the steps of: using said detecting arrangement, detecting a predetermined condition within the treatment chamber; when said predetermined condition is detected at said detecting arrangement generating a signal directed to the power and control unit; and responsive to receipt of said signal directed to said power and control unit, producing a correcting signal directed to the circulation assembly containing the cooling fluid for activation thereof to adjust the condition in the treatment chamber.
8. The method of claim 6, said cooling arrangement comprising a resilient light transparent pocket disposed at the front area of said treatment chamber and including a circulation loop containing a cooling fluid, and wherein said method further includes circulating said cooling fluid within said circulation loop of said light transparent pocket thereby to cool the nails and to improve transmission of laser irradiation energy to the nails.
9. The method of claim 1, wherein said irradiating comprises providing different levels of radiation for different zones of treatment based on results of said detecting at least one of a level of melanin, hemoglobin, and skin water content.
10. The method of claim 1, further comprising a step of cooling the treatment chamber with a cooling plate within the shoe shaped housing.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE INVENTION
(7) The following terms are intended to have the following general meanings as they are used in the application.
(8) Aqueous solution: any type of aqueous solution containing substances capable of eliminating skin pathogens including but not limited to fungus organisms, east and bacterial infection, including athlete's foot etc., treat psoriasis, acceleration of wound healing or treating any other skin disorders. Such substances are capable of either completely eliminating/destroying skin pathogens or substantially delaying reducing the rate of its growth. The treatment solutions include but not limited to the salt solution like sea water and etc., solutions containing Ethanol Alcohol, Isopropyl alcohol, p-Chloro-o-benzylphenol, o-Phenylphenol, Potassium hydroxide, dimethylbenzylammonium chloride, Lactic acid, Hydrogen Peroxide, fluconazole, itraconazole, terbinafine amorolfine, methylphenols, creosols, and any other solutions that inhibits pathogens. Treatment solution may also include substances that promote healthy skin, wound healing and/or psoriasis treatment.
(9) Light at any wavelengths can be absorbed by a skin or nails of the patient. Such wavelengths include wavelengths selected from the continuous electromagnetic spectrum such as ultraviolet (UV), visible, the infrared (near, mid and far) i.e. from approximately 300 nm to 12,000 nm, etc. The light may be produced by any suitable art-disclosed light emitting devices such as lasers, light emitting diodes (LEDs), incandescent sources, fluorescent sources, flash lamps or the like. The light can be pulsed or having a continuous mode. Under Light in this invention one can understand any energy radiation that can penetrate and affect the skin tissue including electromagnetic fields, radio frequency, and acoustic including ultra sound.
(10) The light applied during the irradiating step of the method of the invention can be supplied by a single light emitting device or a plurality of light emitting devices. Any suitable art-disclosed light emitting device(s) such as lasers, light emitting diodes (LEDs), flash lamps, incandescent sources, fluorescent sources, germicidal light or the like may be used to provide the required wavelength(s). Lasers include any art-disclosed lasers such as solid state lasers, diode lasers, pulsed lasers, gas lasers, gas or vapor lasers, dye lasers, fibers lasers or diode pumped solid state lasers or the like. LEDs include any art-disclosed LEDs such as semiconductor LEDs, organic LEDS or a combination thereof. Fluorescent sources include any art-disclosed fluorescent sources such as fluorescent tubes, LED pumped fluorescent devices, cold cathode fluorescent panels or the like.
(11) The light applied during the irradiating step of the method of the invention provides the required wavelength(s). Such wavelength(s) include wavelengths selected from the continuous electromagnetic spectrum such as ultra violet (UV), visible, the infrared (near, mid and far), etc. The wavelength, pulse duration/continuous mode, energy density to the skin or number and repetition rate of energy pulses is optimized to achieve optimal and selective absorption in the skin pathogens or skin components like melanin, oxyhemoglobin or water as well as optimum depth of skin penetration for the best clinical efficacy outcome.
(12) The time required for the step of exposing the infected area to an aqueous solution and the irradiating step of the method may vary depending on the existing conditions (e.g., type of the disease, the skin pathogens, the light source, the aqueous solution, the skin type, melanin concentration in the skin, hemoglobin concentration in the skin, moisture of the skin, temperature of the skin etc.). As to the irradiating step, a suitable duration will generally be from about 1 nanosecond to about 60 minutes. It is also possible and within the scope of the present invention for the light applied during the irradiating step of the therapy to be applied by a lower energy power for much longer durations (e.g., more than about 30 minutes to hours).
(13) Referring now to the drawings, and more particularly to
(14) It should be obvious to a person skilled in the present art that the therapeutic apparatus of the invention can be also adapted for treatment of other parts of a body, which can be easily immersed into the solution contained within the chamber 14, for example, hands.
(15) An inclined supporting platform 18 is disposed within the lower part of the interior of the apparatus. As illustrated in
(16) As the piston 26 is activated, the aqueous solution through the front end 27 of the cylinder and the uni-directional valve arrangement 23 is delivered into the treatment chamber 14. During the treatment, a front of the foot with the toes and toenails, disposed at a low elevation of the front area 15, are submerged into the aqueous solution. The fungus infected toenails are washed, bathed within the aqueous solution, so that the aqueous solution flows around the infected areas. In this manner, the infected toenails are exposed to a greater degree to the medicated aqueous solution than the rest of the foot. Upon completion of this phase of the treatment, the aqueous solution is discharged from the treatment chamber 14 through the discharge unit 40 and the filter 42. As shown in
(17) In one embodiment of the invention, the top surface 20 of the platform supporting the foot is made from a resilient material. To enhance performance of the device, this resilient material is capable of adapting to a specific shape of the foot of the each individual patient. As illustrated in
(18) As illustrated in
(19) Although, the cooling arrangement is in the form of the cooling plate 38 has been discussed hereinabove, it should be understood that any type of cooling arrangement provided to reduce a temperature of the aqueous solution within the treatment chamber is within the scope of the invention. For example, in an alternate embodiment of the invention, the entire supporting platform 18 is made from a resilient material, whereas an inner part of the platform is substantially hollow and filled with a cooling substance/liquid. The cooling substance cools the foot in general and the toes and toenails thereof in particular with the infected areas are treated by the apparatus and method of the invention.
(20) In the embodiment of the apparatus shown in
(21)
(22) Although, the apparatus 100 is formed with the treatment chamber 114 adapted to accommodate various sizes of human foot, an apparatus with a custom-formed treatment chamber designed to accommodate a custom foot configurations of a specific patient is within the scope of the invention. Such custom configured chambers are especially useful for patients with substantial foot deformities, as well as invalids having a part of a foot being removed, etc.
(23) The apparatus of the embodiment illustrated in
(24) In the embodiment of
(25) The resilient material used for manufacturing of the apparatus 100 is impermeable to the aqueous solution. In view of the relatively low cost of production, the apparatus is disposable in nature. The apparatus is convenient for specific treatment sessions arranged for particular patients. The control system 122 positioned outside of the apparatus is reusable and can disconnected from the treatment chamber 114 upon completion of the prescribed treatment. If needed, the control system 122 can be re-connected to another unit. Such arrangement provides substantial cost saving to an operator.
(26) As indicated above, multiple embodiments of the apparatus of the invention including various treatment chambers can be used and adapted for different clinical applications.
(27) The light delivery arrangement 50 of the present invention includes a light source, an energy source in power communication to the light source; and a controller that controls amount and/or duration of light to be applied to the patient by the light source and sensors 32, 35 to measure skin/nails characteristics.
(28) As discussed above, the light source can be any suitable art-disclosed light emitting device(s) such as lasers, LEDs, incandescent sources, fluorescent sources, or the like may be used to provide the required wavelength(s). A light source can be a visible infrared light generated by any conventional sources, including light bulbs, impulseable laser as well as the devices capable of absorbing and concentrating the sunlight.
(29) In the embodiment of the invention illustrated in
(30) One embodiment of the device and method of the invention involve use of arrays of light emitting diodes (LEDs), comprising at least one set of LEDs which emit light at the required wavelength. The set of LEDs is configured within the array in predetermined patterns, and is activated at the required frequency in sequence for predetermined durations of time. In certain aspects of the invention, treatments are provided involving inserting the limb into the device, adjusting for comfort, and activating the device for a pre-programmed treatment of approximately 5-45 minutes.
(31) When a laser is utilized as a light source, the generated beam is controllably absorbed in the target tissue at the required depths.
(32) Utilization of a laser in the present invention as a light source is accompanied by automatic target thermal feedback to precisely control the dosimetry of the laser, intense light or intense pulsed light irradiation. This is needed to prevent damage to surrounding tissue and reduces pain. For this purpose, a non-contact thermal detector can be provided. The output of the non-contact thermal detector is used to adjust the power output of the laser to maintain a selected treatment temperature at the treatment site.
(33) In the invention, absorption of laser energy by the nail bed of the infected toe or finger results in a controlled elevation in temperature, to a temperature effective of disinfection at the infected regions or areas. In the invention, this occurs without causing irreversible thermal damage to the infected nails. The laser control system of the invention adjusts the energy to maintain a pre-selected target temperature at the spot. In one embodiment of the invention, to maximize patient comfort and safety, an optional continuous or pulsed cooling device can be provided to deliver a stream of coolant to the target treatment spot during or after each laser treatment session.
(34) As best illustrated in
(35) To further control the treatment process, a sensor 32 is provided within the treatment chamber 14. The sensor 32 is capable of detecting the level of melanin, hemoglobin or water/moisture content, etc., within the skin of a patient positioned within the chamber. Thus, optimal levels of radiation can be achieved for each zone of treatment. For example, a higher level of radiation can be provided at the front area 15 of the treatment chamber 14 which accommodates toes and toenails infected with a fungus. On the other hand, lower levels of radiation will be generated and directed to the areas of the treatment chamber accommodating a heel and the surrounding regions of the foot. To further control the treatment a condition of the surrounding tissue is monitored by a detecting arrangement or detector 35 adopted to detect irradiation reflected from such tissue. One of the main functions of the detector 35 is to control the effect of the energy or light source on the surrounding tissue of a patient. In every individual case a doctor sets specific characteristics of the irradiation to produce the required effect. If situation in the treatment chamber become unfavorable, for example the temperature exceeds predetermined limits, the detector 35 generates a signal directed to the control unit 8 which in turn produces a correcting signal to the power unit or to the control arrangement 28 of the cooling system 22. This in turn energizes circulation pumps 37 and/or cooling plates 38, so as to directly and indirectly lower temperature in the treatment chamber 14. Similar signals can be also produced when the prearranged levels of the energy density, power density or other characteristics of the operating laser are attained. This is necessary to exclude possibility of damaging an adjacent healthy skin tissue. The detecting arrangement 35 can be made utilizing a wide variety of photoelements, photoresistors, photodiodes and similar devices.
(36) In the embodiment of the invention illustrated in
(37) In a further embodiment of the invention, the inner surface of the treatment chamber 14 is covered by a light reflective material. In this manner, the energy of the light sources disposed at the reflected layer are fully reflected and directed to the foot positioned within the treatment chamber 14.
(38) According to still yet another embodiment of the invention, the inner area of the treatment chamber is covered by a plastic material impermeable to the aqueous solution, and transparent to light radiation generated by the energy/light sources. Thus, the plastic material forms a disposable envelope adapted to accommodate a foot of a patient and usable only during a specific treatment session arranged for a particular individual/patient. The envelope is removed from the apparatus upon completion of the treatment and properly disposed. Use of such disposable envelopes prevents transmission of fungus and other diseases from one patient to another.
(39) According to an essential aspect of the invention, the refractive index of the aqueous solution and/or any other material or substance which is in contact with the skin surface of a patient, should match or to be substantially identical to the refractive index of the skin of the patient itself. The same principal is applicable to light sources used in the apparatus and the method of the invention. This means that the refractive index of a transparent light window surface (through which the light is irradiated by the light source) should match or be substantially identical to the refractive index of the material in contact with it and eventually with the skin surface of a patient.
(40) In a still further embodiment of the invention, a pressure source can be provided within the treatment chamber 14. This embodiment is especially beneficial with the treatment chamber being formed with resilient walls or when the flexible plastic envelope 44 is used in the chamber. Thus, upon pressure being elevated, the resilient walls or the flexible envelope disposed within the treatment chamber closely surrounds the foot and the toes subjected to a treatment within the chamber. This arrangement makes the steps of applying the aqueous solution or irradiating the step of irradiation even more efficient.
(41) According to the method of the invention, initially the foot partially submerged into an aqueous solution can be also subjected to a light radiation treatment. The level of the solution within the treatment chamber is periodically raised, so as to cover the entire surface of the foot. After completion of the treatment, the solution is removed into a reservoir or recycled; and the foot is dried by an air stream formed by a vacuuming air-pump which can be connected to the treatment chamber 14 through the exit tube 40.
(42) The method of the present invention also includes the steps of irradiating the infected area with the light or energy sources 16, 34 at a wavelength absorbed by skin chloroforms including but not limited to melanin, hemoglobin, oxyhemoglobin, or water in the skin or nails of a patient, so as to destroy fungal and/or bacterial infection, and/or microbes, and/or coagulate contaminated or diseased tissue in the nail, under the nail, in the nail matrix or at any other affected are of the skin. Since light can penetrate through the skin and through the nail, the irradiating step is achieved by irradiating either directly or indirectly through the nail with a light source at the required wavelength, so as to destroy infected material on the nail bed as well as in the matrix below and around the nail bed.
(43) In the method of the invention, the steps of treating the infected area by an aqueous solution and the step of irradiating the infective area with a light source can be conducted separately/independently of each other or in combination.