Treatment apparatus and mechanisms for an infected nail

Abstract

A method of treating nail infections that uses nail protein removing compositions to reduce cell to cell cohesion; antimicrobial composition to reduce surface tension, inhibit spores, and attack infection cell membranes; an enclosure capable of heating the antimicrobial composition above nail temperature and capable of dispensing antimicrobial composition to infected nails.

Claims

1. A method for the treatment of an infection of a nail or nail bed of an individual suffering from said infection, comprising: a nail protein removing composition that reduces protein cell to cell cohesion; an antimicrobial composition that reduces surface tension, inhibits spores, and attacks infection cell membranes.

2. The method of claim 1 wherein the antimicrobial composition disrupts proteins in infection cells.

3. The method of claim 1 wherein the antimicrobial composition disrupts nucleic acids in infection cells.

4. The method of claim 1 wherein the antimicrobial composition attaches to infection cell phospholipids.

5. The method of claim 1 wherein the antimicrobial composition is a solution.

6. The method of claim 1 wherein the antimicrobial composition congeals the cytoplasm in the infection cells.

7. The method of claim 1 wherein the components in the antimicrobial composition are dissolved in water.

8. A method for the treatment of an infection of a nail or nail bed of an individual suffering from said infection, comprising: an enclosure capable of housing at least one digit of a patient with an infected nail or nail bed and; said enclosure is capable of heating an antimicrobial composition above nail temperature and; said enclosure is capable of dispensing said antimicrobial composition to said infected nail or nail bed and; said antimicrobial composition reduces surface tension, inhibits spores and attacks infection cell membranes.

9. The method of claim 8 wherein the enclosure soaks the infected nail or nail bed in an antimicrobial composition.

10. The method of claim 8 wherein the enclosure sprays an antimicrobial composition onto the infected nail or nail bed.

11. The method of claim 8 wherein the enclosure agitates an antimicrobial composition onto the infected nail or nail bed.

12. The method of claim 8 wherein the enclosure uses a pump and spray nozzle to dispense an antimicrobial composition onto an infected nail or nail bed.

13. The method of claim 8 wherein the enclosure uses a motor and impeller to dispense an antimycrobial composition onto an infected nail or nail bed.

14. The method of claim 8 wherein the enclosure uses batteries.

15. A method for the treatment of an infection of a nail or nail bed of an individual suffering from said infection, comprising: an enclosure capable of housing at least one digit of a patient with an infected nail or nail bed and; said enclosure is capable of containing an antimicrobial composition; said enclosure is capable of being externally heated with said antimicrobial composition above nail temperature; said enclosure is capable of dispensing said antimicrobial composition to said infected nail or nail bed and; said antimicrobial composition reduces surface tension, inhibits spore outgrowth, and attacks infection cell membranes.

16. The method of claim 12 wherein the enclosure and antimicrobial composition may be heated using a microwave oven.

17. The method of claim 12 wherein the enclosure and antimicrobial composition may be heated using a conventional oven.

18. The method of claim 12 wherein the enclosure and antimicrobial composition may be heated using a stove top.

Description

DRAWINGS

[0035] Table A Embodiment 1Heating Soaking Pan (FIGS. 1-3)

[0036] FIG. 1 Isometric View

[0037] FIG. 2 Cross Section View

[0038] FIG. 3 Bottom View

[0039] Table B Embodiment 2Heated Spray Device (FIGS. 4-7)

[0040] FIG. 4 Isometric View

[0041] FIG. 5 Isometric View

[0042] FIG. 6 Cross Section View

[0043] FIG. 7 Bottom View

[0044] Table C Embodiment 3 Heated Agitation Device (FIGS. 8-11)

[0045] FIG. 8 Isometric View

[0046] FIG. 9 Isometric View

[0047] FIG. 10 Cross Section View

[0048] FIG. 11 Bottom View

[0049] Table D Embodiment 4Microwave Heated Soaking Pan (FIGS. 12-13)

[0050] FIG. 12 Isometric View

[0051] FIG. 13 Cross Section View

DETAILED DESCRIPTION OF THE INVENTION

[0052] The following description of the invention will typically be with reference to embodiments and methods. It is to be appreciated that there is no intention to limit the invention to the specifically disclosed embodiments and methods but that the invention may be practiced using other features, elements, methods and embodiments not to limit its scope, which is defined by the claims. Those of ordinary skill in the art will recognize a variety of equivalent variations on the description that follows.

Apparatus

[0053] Accordingly, Tables A, B, C and D and FIGS. 1-13 provide a detailed description of the components used in the heated soaking device apparatus.

Table A Embodiment 1Heated Soaking Pan (FIGS. 1-3)

[0054] Base 1 can be made of any rigid corrosion resistant material including aluminum or ABS plastic and functions as the support structure for infected nail 14 and soaking pan 3. Soaking pan 3 is made from any thermally conductive corrosion resistant metal such as aluminum or copper and creates the volume that encloses treatment solution 18, heater 4, and the infected nails 14. Heater 4 is typically an off the shelf resistance type heater, and is made from thermally conductive metal (copper, aluminum) wires embedded in kapton or silicone. Base cover 2 can be made from any corrosion resistant material including aluminum or ABS plastic and serves to cover the electrical components inside base 1 and to support infected nail 14.

[0055] Treatment solution 18 is made from off the shelf components and mixed to the proper concentration to treat infections. Treatment solution container 17 is purchased off the shelf and is made from a variety of materials, most commonly the same inert plastic material as the original packaging for treatment solution 18 or HDPE. Power switch 5 is screwed into base 1 and turns the device on or off Power connector 6 is screwed into base 1 and relays the power from power supply 12 (plugged into a wall outlet) through power switch 5 to battery charger 16 to heater 4. Battery charger 16 is mounted inside base 1 and uses electricity from power supply 12 to recharge batteries 15 for portable use.

[0056] High temperature adhesive 8 is typically silicone based and is purchased off the shelf to secure heater 4 to base 1. Insulation 7 is purchased off the shelf and is made from a variety of inert materials including buna nitrile and neoprene and insulates the electrical components inside base 1 from treatment solution 18. Corrosive resistant screws 11 (aluminum or stainless steel) secure rubber bumpers 10 to base 1 through standoffs 13. Rubber bumpers 10 create space under the device for heater 4 and also electrically insulate the device from ground.

[0057] Treatment solution 18 is poured from treatment solution container 17 into soaking pan 3 to cover infected nail 14 and heated using heater 4 and heater plate 9. Infected nail 14 is soaked for 15 minutes once daily for three to four months at 45 C. max.

Table B Embodiment 2Heated Spray Device (FIGS. 4-7)

[0058] Base 1 can be made of any rigid corrosion resistant material including aluminum or ABS plastic and functions as the support structure for infected nail 14, soaking pan/reservoir 3 and base cover 2. Soaking pan/reservoir 3 is a cavity inside base 1 and creates the volume that encloses treatment solution 18, heater plate 9 and the infected nails 14. Heater 4 is an off the shelf resistance type heater and can be made from a nickel-chromium alloy embedded in kapton or silicone and transfers heat through heater plate 9 to treatment solution 18.

[0059] Heater plate 9 can be made of any thermally conductive material such as aluminum or copper and transfers heat from heater 4 to treatment solution 18 and seals soaking pan/reservior 3 using high temperature adhesive 8. Base cover 2 can be made from any corrosion resistant material including aluminum or ABS plastic and serves to cover infected nails 14 and provide support for insulation 7. Insulation 7 is purchased off the shelf and is made from a variety of inert materials including buna nitrile and neoprene and provides a liquid seal to keep treatment solution 18 inside base 1 and base 2.

[0060] Treatment solution 18 is made from off the shelf antimicrobial components and mixed to the proper concentration to treat infections. Power switch 5 is a purchased part and is screwed into base 1 and controls the electrical connection between heater 4, rechargeable batteries 15, power supply 12 and pump 21 to heat and spray treatment solution 18 onto infected nail(s) 14. Power connector 6 is screwed into base 1 and relays the power from power supply 12 (plugged into a wall outlet) through power switch 5 to rechargeable batteries 15 to heater 4. Rechargeable batteries 15 are purchased off the shelf and used to operate the device away from a wall outlet. Power supply 12 is a purchased part and converts electricity from a wall outlet so it's useable by heater 4 and pump 21.

[0061] High temperature adhesive 8 is usually silicone based and is purchased off the shelf to secure heater 4 to base 1 and also secures hinge 23 and latch 22 to base 1 and base 2. Hinge 23 is a purchased part and can be made from aluminum, steel, or ABS plastic and allows base 2 to rotate open to insert infected nail(s) 14 and treatment solution 18. Latch 22 is a purchased component made from metal or plastic and secures base 1 and base 2 together.

[0062] Treatment solution 18 is poured into soaking pan/reservoir 3 where pump 21 pumps it through tubing 19 and spray nozzle 20 onto infected nail(s) 14. Pump 21, tubing 19, and spray nozzle 20 are all purchased components.

Table C Embodiment 3Heated Agitation Device (FIGS. 8-11)

[0063] Base 1 can be made of any rigid corrosion resistant material including aluminum or ABS plastic and functions as the support structure for infected nail 14, soaking pan/reservoir 3 and base cover 2. Soaking pan/reservoir 3 is a cavity inside base 1 and creates the volume that encloses treatment solution 18, heater plate 9 and the infected nails 14. Heater 4 is an off the shelf resistance type heater and can be made from a nickel-chromium alloy embedded in kapton or silicone and transfers heat through heater plate 9 to treatment solution 18.

[0064] Heater plate 9 can be made of any thermally conductive material such as aluminum or copper and transfers heat from heater 4 to treatment solution 18 and seals soaking pan/reservior 3 using high temperature adhesive 8. Base cover 2 can be made from any corrosion resistant material including aluminum or ABS plastic and serves to cover infected nails 14 and provide support for insulation 7. Insulation 7 is purchased off the shelf and is made from a variety of inert materials including buna nitrile and neoprene and provides a liquid seal to keep treatment solution 18 inside base 1 and base 2.

[0065] Treatment solution 18 is made from off the shelf antimicrobial components and mixed to the proper concentration to treat infections. Power switch 5 is a purchased part and is screwed into base 1 and controls the electrical connection between heater 4, rechargeable batteries 15, power supply 12 and motor 21 to heat and agitate treatment solution 18 onto infected nail(s) 14 using impeller 20. Power connector 6 is screwed into base 1 and relays the power from power supply 12 (plugged into a wall outlet) through power switch 5 to rechargeable batteries 15 to heater 4. Rechargeable batteries 15 are purchased off the shelf and used to operate the device away from a wall outlet. Power supply 12 is a purchased part and converts electricity from a wall outlet so it's useable by heater 4 and motor 21.

[0066] High temperature adhesive 8 is usually silicone based and is purchased off the shelf to secure heater 4 to base 1 and also secures hinge 23 and latch 22 to base 1 and base 2. Hinge 23 is a purchased part and can be made from aluminum, steel, or ABS plastic and allows base 2 to rotate open to insert infected nail(s) 14 and treatment solution 18. Latch 22 is a purchased component made from metal or plastic and secures base 1 and base 2 together.

[0067] Treatment solution 18 is poured into soaking pan/reservoir 3 where motor 21 and impeller 20 agitate it onto infected nail(s) 14. Motor 21 and impeller 20 are purchased parts. Motor 21 rotates impeller 20.

Table D Embodiment 4Microwave Heated Soaking Pan (FIGS. 12-13)

[0068] Base and cover 1 are purchased components and are made of a microwaveable plastic such as polypropylene. Treatment solution 3 is poured into the base open volume and the cover seals insulation 2 inside the base closed volume. Base and cover 1, insulation 2 and treatment solution 3 is placed in the microwave and warmed until treatment solution 3 is a maximum temperature of 45 C. Infected nail(s) 4 are soaked in warm treatment solution 3. Insulation 2 is purchased off the shelf and is made from a variety of inert materials including buna nitrile, neoprene and water and keeps treatment solution 3 warm while infected nail(s) 4 are soaking.

Mechanisms

[0069] Protein removing mechanisms that disrupt, remove protein and reduce cell to cell cohesion are typically used in treating acne and warts on skin. Compositions with protein removing mechanisms are well known and available from commercial laboratories such as Santa Cruz Biotechnology (SC) and Sigma Aldrich (SA) under such part numbers as: SC-215227; 229790; 215933; 203371; 296681; 203374; 29114; 250284; 209002; 210706; 257106; 391055; 214588; and SA-05670; P4762; 777161; P-7545; P5380; R7632 or combinations thereof.

[0070] Protein removing compositions in safe concentrations range from 30% to 50% (applied in combination or individually) may be applied to the infected nail(s) separately once per day for up to 90 days or included with the treatment solution and heated for soaking the infected nail(s).

[0071] Antimicrobial cationic surfactant mechanisms that reduce surface tension, inhibit spore outgrowth, disrupt cytoplasmic membranes, degrade proteins and nucleic acids and lysis cell walls are typically used as surface disinfectants. Compositions with antimicrobial cationic surfactant mechanisms are well known and available from commercial laboratories such as: Makon NF-5 (Stepan Company, Northfield, Ill.); Arquad@ 2HT-75 (Akzo Chemicals Inc., Chicago, Ill.); Kemamine BQ-9742C (Witco Chemical Corp., Memphis, Tenn.) Kemamine Q-9702C (Witco Chemical Corp.), Accosoft 750 (Stepan Co. Northfield, Ill.) and Accosoft 501 (Stepan Company).

[0072] Antimicrobial cationic surfactant compositions in safe concentrations less than 0.3% are heated above nail temperature and penetrate the infected nail with water.

[0073] Nitrogenous carbon antimicrobial compositions attach to phospholipids in cytoplasmic membranes and cause an irreversible loss of essential cellular components. These mechanisms also bind to DNA and other nucleic acids and precipitates them from aqueous solution thereby damaging or inactivating DNA.

[0074] Compositions with nitrogenous carbon mechanisms are well known and are typically used as public water treatments and surface disinfectants. These antimycrobials include but are not limited to and are commercially available: Lonza (88865); Aventis Pharma (Brolene); Typharm (Golden Eye); Merck (Aurigoutte); Pierre Fabre (Cyteal); and Betadine (Betasept).

[0075] Nitrogenous carbon compositions in safe concentrations less than 0.3% are heated above nail temperature and penetrate infected nail(s) with water.

[0076] One or more antimicrobial cationic surfactant (concentration in water less than 0.3%) and/or one or more nitrogenous carbon antimicrobial (concentration in water less than 0.3%) are mixed with water and together are absorbed into the infected nail(s). Protein removing compositions may be applied separately to infected nail(s) (concentration less than 30%) or included with the antimicrobial cationic surfactant and the nitrogenous carbon composition with water (concentration less than 50%).

[0077] The mixture is heated above nail temperature (usually usually 5-10 C. less than body temperature of 37 C. and less than the FDA maximum of 45 C.). Heat energy helps the mixture overcome the infected nail's natural resistance to absorption (why nails soften in warm water and harden in cold water).

[0078] Embodiments may include one or more protein removing composition, one or more antimicrobial cationic surfactant composition and water heated above nail temperature. Other embodiments may include one or more protein removing composition, one or more nitrogenous carbon composition and water heated above nail temperature. Further embodiments may include one or more protein removing composition, one or more antimicrobial cationic surfactant composition, one or more nitrogenous carbon composition and water heated above nail temperature.

[0079] Safe therapeutically effective concentrations of keratolytic ingredients for all embodiments is less than 50%; for antimicrobial cationic surfactant composition is less than 0.3%; and for nitrogenous carbon composition less than 0.3%. Temperature range for all embodiments is above nail temperature (usually 5-10 C. less than body temperature of 37 C. and less than the FDA maximum of 45 C.).

[0080] Treatment duration depends on the severity of the infection and ranges from soaking infected nails in warm treatment solution from 5 to 15 minutes once per day for 20 to 120 days.

[0081] The treatment of an infected nail requires administering an agent to a subject having an infected nail. The terms administration or administering refer to a method of incorporating a composition into the cells or tissues of a subject, either in vivo or ex vivo to diagnose, prevent, treat, or ameliorate a symptom of a disease. In one example, a compound can be administered directly to the affected tissue of a subject. In another example, a compound can be administered to a subject by combining the compound with cell tissue from the subject ex vivo for purposes that include, but are not limited to, assays for determining utility and efficacy of a composition. When the compound is incorporated on the subject in combination with one or active agents, the terms administration or administering can include sequential or incorporation concurrent incorporation of the compound with the other agents such as, for example, any agent described above. A pharmaceutical composition of the embodiment is formulated to be compatible with its intended route of administration.

[0082] An effective amount of a compound of the embodiment can be used to describe a therapeutically effective amount or a prophylactically effective amount. An effective amount can also be an amount that ameliorates the symptoms of a disease. A therapeutically effective amount refers to an amount that is effective at the dosages and periods of time necessary to achieve a desired therapeutic result and may also refer to an amount of an active compound, drug or pharmaceutical agent that elicits any biological or medicinal response in a tissue, system, or subject that is sought by a researcher, veterinarian, medical doctor or other clinician that may be part of a treatment plan leading to a desired effect.

[0083] The term treating refers to the administering one or more therapeutic or prophylactic agents taught herein. A prophylactically effective amount refers to an amount that is effective at the dosages and periods of time necessary to achieve a desired prophylactic result such as, preventing or inhibiting the severity of condition. Typically, a prophylactic dose is used in a subject prior to the onset of a disease, or at an early stage of the onset of a disease, to prevent or inhibit onset of the disease or symptoms of the disease. A prophylactically effective amount may be less than, greater than, or equal to a therapeutically effective amount.

[0084] In some embodiments, the therapeutically effective amount may need to be administered in an amount sufficient to result in amelioration of one or more symptoms of a disorder, prevention of the advancement of a disorder, or regression of a disorder. In one example, a therapeutically effective amount preferably refers to the amount of a therapeutic mechanism that provides a measurable response of at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, at least 95%, or at least 100% of a desired action of the mode of action.

EXAMPLES

Example 1

[0085] A subject having a nail infection diagnosis of a Trichophyton genus was treated using a variety of the methods taught herein. The presence of hyphae in the subject was consistent with Trichophyton rubrum and or Trichophyton mentagrophytes (the diagnosis of mixed infections is difficult to determine accurately). Nails infected with these organisms also produce a chronic type of tinea pedis. Infections involving the interdigital areas can produce erythema, fissuring, and may extend into other portions of the hand or foot.

[0086] In this example, the infected nail was periodically trimmed during the 90 day treatment period and pretreated with a 30% protein removing composition once daily. Following pretreatment, the infected nail was soaked in a mixture of 0.10% antimicrobial cationic surfactant composition and 0.15% nitrogenous carbon composition in water and heated above nail temperature (approximately 40 C.) for 10 to 15 minutes daily during the treatment period.

Example 2

[0087] A subject having an nail infection diagnosis of a Trichophyton genus was treated using a variety of the methods taught herein. The presence of hyphae in the subject was consistent with Trichophyton rubrum and or Trichophyton mentagrophytes (the diagnosis of mixed infections is difficult to determine accurately). Nails infected with these organisms also produce a chronic type of tinea pedis. Infections involving the interdigital areas can produce erythema, fissuring, and may extend into other portions of the hand or foot.

[0088] In this example, the infected nail was periodically trimmed during the 90 day treatment period. After trimming, the infected nail was soaked in a mixture of 30% protein removing composition, 0.10% antimicrobial cationic surfactant composition and 0.15% nitrogenous carbon composition in water and heated above nail temperature (approximately 40 C.) for 10 to 15 minutes daily during the treatment period.

[0089] Examples 1 and 2 show the successful treatment of an infected nail using the teachings described herein. As can be seen from the figures, this treatment eliminates the infection and provides clinical cure.

TABLE-US-00001 TABLE A Embodiment 1 - Heated Soaking Pan (FIGS. 1-3) Item No. Description Quantity Mfg/Supplier Ref Part No. 1 Base 1 Custom N/A 2 Base Cover 1 Custom N/A 3 Soaking Pan 1 Custom N/A 4 Heater 1 McMaster-Carr 7945T42 5 Power Switch 1 Radio Shack 275-712 6 Power Connector 1 Radio Shack 274-1576 7 Insulation A/R McMaster-Carr 8635K26 8 High Temperature A/R McMaster-Carr 75825A5 Adhesive 9 Heater Plate 1 Custom N/A 10 Rubber Bumper 6 Mcmaster-Carr 9540K724 11 Screws 8 Mcmaster-Carr 91735A109 12 Power Supply 1 Radio Shack 273-029 13 Standoffs 8 Mcmaster-Carr 93330A430 14 Infected Nail(s) 1 N/A N/A 15 Rechargeable 4 Eveready NH15-AA Batteries 16 Battery Charger 1 Eveready CHDC-CA 17 Treatment Solution 1 US Plastics 73036 Container 18 Treatment Solution A/R Arquad, Lonza Varies by Sigma Aldrich Manufacturer

TABLE-US-00002 TABLE B Embodiment 2 - Heated Spray Device (FIGS. 4-7) Item No. Description Quantity Mfg/Supplier Ref Part No. 1 Base 1 Custom N/A 2 Base Cover 1 Custom N/A 3 Soaking Pan/ 1 Custom N/A Reservoir 4 Heater 1 McMaster-Carr 7945T42 5 Power Switch 1 Radio Shack 275-712 6 Power Connector 1 Radio Shack 274-1576 7 Insulation A/R McMaster-Carr 8635K26 8 High Temperature A/R McMaster-Carr 75825A5 Adhesive 9 Heater Plate 1 Custom N/A 12 Power Supply 1 Radio Shack 273-029 14 Infected Nail(s) 1 N/A N/A 15 Rechargeable 4 Eveready NH15-AA Batteries 18 Treatment A/R Arquad, Lonza Varies by Solution Sigma Aldrich Manufacturer 19 Tubing A/R US Plastics 57270 20 Spray Nozzle 2 TCP Global TCPP5500-10 21 Submersible 1 Edmund (Faller) 180627 Pump 22 Latch 2 Southco 97-30-16--11 23 Hinge 1 Southco C6-220

TABLE-US-00003 TABLE C Embodiment 3 - Heated Agitation Device (FIGS. 8-11) Item No. Description Quantity Mfg/Supplier Ref Part No. 1 Base 1 Custom N/A 2 Base Cover 1 Custom N/A 4 Heater 1 McMaster-Carr 7945T42 5 Power Switch 1 Radio Shack 275-712 6 Power Connector 1 Radio Shack 274-1576 7 Insulation A/R McMaster-Carr 8635K26 8 High Temperature A/R McMaster-Carr 75825A5 Adhesive 9 Heater Plate 1 Custom N/A 10 Infected Nail(s) 1 N/A N/A 12 Power Supply 1 Radio Shack 273-029 13 Rechargeable 1 Eveready NH15-AA Batteries 15 Soaking Pan/ 1 Custom N/A Reservoir 18 Treatment Solution A/R Arquad, Lonza Varies by Sigma Aldrich Manufacturer 20 Impeller 1 NuTone 68920000 21 Motor 1 McMaster-Carr 6331K13 22 Latch 2 Southco 97-30-16--11 23 Hinge 1 Southco C6-220

TABLE-US-00004 TABLE D Embodiment 4 - Microwave Heated Soaking Pan (FIGS. 12-13) Item No. Description Quantity Mfg/Supplier Ref Part No. 1 Base and cover 1 Bed Bath & 12356110 Beyond 2 Insulation A/R medicalproduct BG1114 sonline.org 3 Treatment Solution A/R Arquad, Lonza Varies by Sigma Aldrich Manufacturer 4 Infected Nail(s) 1 N/A N/A