US20070256212A1

US20070256212A1 - Device For Delivery Of Agents To And Through The Human Scalp

Info

Publication number: US20070256212A1
Application number: US11/694,615
Authority: US
Inventors: Michael I. Rabin
Original assignee: Transdermal Cap Inc
Current assignee: Transdermal Cap Inc
Priority date: 2006-04-20
Filing date: 2007-03-30
Publication date: 2007-11-08
Also published as: WO2007124446A2; WO2007124446A3

Abstract

A method and device for administering minoxidil and other topical solutions to the scalp. The method entails administering a minoxidil preparation through a manifold that fits over the scalp of a patient, and placing a moisture barrier over the scalp for a period of time effective to enhance absorption of the minoxidil preparation by the scalp.

Description

This application claims priority to U.S. Provisional Application 60/745,269 filed Apr. 20, 2006.

FIELD OF THE INVENTIONS

The inventions described below relate the field of hair regrowth and treatments for baldness.

BACKGROUND OF THE INVENTION

Minoxidil has proven to be an effective treatment for baldness. Specifically, it can stop and reverse ongoing hair loss and stimulate hair growth in adult men and women who are losing hair due to male or female pattern baldness (androgenic alopecia). However, minoxidil is only effective if properly applied. Minoxidil is applied with an eye-dropper, followed by careful massage of the applied solution to distribute it over the scalp. This is a tedious process, given that the typical user must apply minoxidil through the hair, and avoid wasting the minoxidil by wetting the hair instead of the scalp. Minoxidil must be applied twice daily for effective treatment. The desired result of renewed hair growth is obtained after several weeks or months of use. The twice-daily regimen must be continued indefinitely to maintain the effect, and if discontinued, any hair re-grown will be lost.
Due to the tedious nature of the regimen, most patients do not comply with the regimen. Because they do not maintain the regimen, the drug does not work, and patients discontinue the regimen, thereby abandoning an otherwise beneficial treatment.

SUMMARY

The devices and methods described below provide for a more convenient application of minoxidil to the scalp, to enhance patient compliance and/or permit a less rigorous treatment regimen. The device comprises a hat with a distribution manifold adapted to distribute minoxidil about the scalp, an injection port for injecting minoxidil into the manifold, and a reservoir for taking up a dose of minoxidil and injecting it into the manifold. The manifold includes numerous outlet nozzles that protrude, when the cap is in place, from the interior of the hat toward the scalp of the patient, and preferably contact the scalp. The hat is used by the patient by injecting a minoxidil solution into the manifold and hence through the nozzles onto the scalp, and thereafter wearing the hat for a period of time suitable to promote absorption of the distributed minoxidil.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a bottom perspective view of the cap to be used for distribution of minoxidil to the scalp of a patient.

FIG. 2 is a bottom view of a manifold used with the cap of FIG. 1.

FIG. 3 is a side view of cap to be used for distribution of minoxidil to the scalp of a patient.

FIG. 4 illustrates a reservoir for use with the cap.

FIG. 5 illustrates an alternative embodiment of the manifold.

DETAILED DESCRIPTION OF THE INVENTIONS

FIG. 1 is a bottom view of cap 1 to be used for distribution of hair-regrowth topical solutions, such as minoxidil preparations, to the scalp of a patient. The cap covers a manifold 2 supporting an array of nozzles 3 distributed about the inner surface of the hat. The manifold comprises several arms 4 with lumens 5 communicating with the nozzles. The manifold arms may be embedded in, or covered by, a neoprene liner which fits within the cap. An occlusive band 6 is disposed about the perimeter of the cap, on the interior surface. The occlusive band may be elastic and tight-fitting to provide a tight-fitting sealing gasket between the user's scalp and the cap, or may be somewhat loose and merely promote creation of a closed environment of relatively high humidity immediately proximate the scalp.
The manifold 2 is shown more clearly in FIG. 2, in which the manifold and the several arms are shown. The lumens 5 (shown in phantom) extend from the plenum or distribution chamber 7 in the center of the manifold, and are in fluid communication with the valved fitting 8 and the several nozzles providing outlet ports from the lumen. The manifold may be embedded in or covered with material 9 such as neoprene, cloth, polyurethane or other suitable material, such that any tubing establishing the lumens, or manifold arms, are conveniently held in the desired array. This material, or the material of the cap, is provided in sufficient density to serve as a moisture barrier to enclose the environment immediately about the hair and/or scalp while in use.
The nozzles 3 are arranged on the interior surface of the cap so that, when the cap is worn, the nozzles will be disposed proximate the appropriate treatment target zones on the scalp, such as the vertex, occiput (back of the head), and frontal areas, and project toward the scalp from the interior surface of the manifold. Additional projections 10 can be provided on the interior surface of the cap. Both the nozzles and the additional projections can be formed in various sizes and profiles, such as blunt flat distal faces or sharp or abrasive distal surfaces, to aid in distribution of the applied minoxidil, or to provide complimentary treatment such as micro-abrasion. Some of the projections may be taller than nearby nozzles to maintain a small gap between the nozzles and the scalp. The manifold and manifold arms are sized and dimensioned, and positioned within the cap, so that they lie over the desired portions of the scalp (vertex, occiput, and frontal areas) when the cap is worn in typical fashion (bill forward, hat band level on the head). The lumens of the manifold are sized to permit slow drainage of the minoxidil preparation, which may be watery or slightly viscous, and the lumens may be varied in size to suit the actual viscosity of the preparation used (commercially available minoxidil preparations such as Rogaine® have low viscosity, like water, though they are mixture of ethanol and slightly viscous propylene glycol).
FIG. 3 is a side view of the cap of FIG. 1. An inlet port in form of a valved fitting 8 is disposed on the exterior of the cap, and provides a fluid pathway for injecting minoxidil into the manifold. The fitting is adapted to receive a minoxidil preparation from a source such as a pressurized can or bellows reservoir. The fitting is in fluid communication with lumens of the manifold, and is disposed in the central plenum connecting the various manifold arms. The baseball cap provides positioning support for the manifold and nozzle array, positioning support for the seal, and ornamental disguise for the manifold. The baseball cap may be replaced by any style of hat, or altogether omitted if the occlusive band 6 (or other head band) is secured to the manifold, or if the moisture barrier is sufficiently sturdy to maintain the form of manifold (either or both may be used in combination without the cap). Any style of cap may provide the desired support and positioning means for the manifold and nozzle array, and any style of cap, hat, headband or hood can be used as the means of disguise. Also, the manifold may be used without the cap, moisture barrier or occlusive band to distribute the preparation.
A suitable reservoir 11, shown in FIG. 4 is sized to hold a single dose of minoxidil preparation. This reservoir is a bladder or bellows pump, with an outlet 12 adapted to provide a sealed connection with the cap fitting 8 and an inlet check valve 13 to take in air that can subsequently be pumped into the manifold to force the entire dose of minoxidil through the manifold and onto the scalp. The bellows may be sized to accommodate a single dose of preparation, and may be provided as a disposable or re-usable form. As an alternative, a typical bladder pump of the type used to inflate bladders in clothing can be installed in the cap, and the minoxidil preparation can be supplied in single dose capsules that can be fitted to the intake of the bladder pump such that operation of the pump first empties the bladder into the manifold and then pumps air or other fluid suitable for clearing the manifold into the manifold to clear the manifold. Any other pump means may be used, including simple syringes, squeeze bottles, tubes, etc., with appropriate connectors for connection to the cap, in place of the bladder pump.
FIG. 5 illustrates an alternative embodiment of the manifold, which includes a brush-like body 14 with numerous nozzles 3 and projections 10 depending downwardly (or toward the scalp) from the body toward the scalp when positioned, along with the cap, on the user's head. When fitted within the cap, the manifold is bowl-shaped. The brush like body is sized and dimensioned, and positioned within the cap, so that it lies over the vertex of the head when the cap is worn in typical fashion (bill forward, hat band level on the head).
To use the cap, a user wears the cap in regular sessions, according to the appropriate treatment regimen, applying the minoxidil preparation through the cap for each session. Twice daily sessions, in which the cap is worn for about an hour, are adequate to provide effective treatment in lieu of the twice-daily eye-dropper application. A 1 cc volume of standard commercially available minoxidil preparation, or other amount effective to promote hair growth in other formulations, may be used. The injection of minoxidil may be accomplished before or after the user dons the cap, but the flushing of air or other fluid to clear the manifold should be done when the cap is in place. While wearing the cap, the user may engage in any activity, preferably for about 10 to 60 minutes, and more preferably for about 15 minutes. The user thereby holds the vapor barrier over the scalp for a period after application effective to enhance absorption of the minoxidil preparation by the scalp. After each session, the user may wash and style his hair as usual.
The device and method may be used to for hair re-growth using minoxidil or other hear re-growth compounds to re-grow hair, or prophylactically to prevent hair loss, or both. While minoxidil is generally referred to as a hair regrowth preparation, it also functions as a prophylactic hair maintenance preparation. Other compounds that perform solely as prophylactic hair maintenance preparations may be used in the method.
As mentioned above, the reservoir may be provided as a single dose reservoir, in either disposable or re-usable form. The re-usable reservoir is used by first connecting the suction end of the bellows/bladder pump to a larger reservoir of minoxidil preparation and operating the pump to fill the reservoir, and thereafter connecting the outlet end of the pump to the inlet port of the cap and operating the pump to pump the minoxidil preparation into the manifold, and then pump air into the manifold to flush any minoxidil preparation in the manifold onto the scalp.
The device may be augmented with features that assist in the penetration or retention of the hair regrowth preparation, or augment the hair re-growth by other mechanisms. As mentioned above, the nozzles and projections may be modified with the addition of abrasive surfaces, bristles, or sharp, needle-like projections to provide for micro-abrasion of the scalp that is accomplished by the normal movements of the cap during use. The nozzles may be tipped with sponge or other absorbent material to aid in distribution of the preparation. For patients that are bald, either by choice or advanced hair loss, the manifold may be covered, over its interior surfaces, by a sheet of sponge, felt or other diffusive material. Also for patients with short hair or no hair, the nozzles may be very short, or omitted altogether, so that ports on the interior of the manifold open directly onto the scalp. The devices may be augmented with the addition of LED's or other light sources to provide illumination in the interior of the cap, to irradiate the scalp with appropriate visible light wavelengths, as taught by Yorke, Apparatus And Method For Hair Retention And Regeneration, U.S. Pub. 2004/0153131 (Aug. 5, 2005), or with other suitable wavelengths.
The devices and methods described above have been described in relationship to the application of minoxidil, which is the currently predominant hair re-growth preparation available today. Nonetheless, the devices and methods may be employed with any other hair re-growth compound or preparation, any hair loss prophylactic preparation, and with other cosmetic and/or therapeutic agents such as topical finasteride, minoxidil, ketoconazole, steroids, other anti-microbials, steroids, copper peptides for post-hair transplantation wound healing, anti-androgens, antimicrobials, spironolactone, spironolactone-like compounds, progesterone derivatives, betametazone valerate, ketoconazole, zinc salts, Zinc Pyrithione ZnP, finasteride, flutamide, dutasteride, melatonin, photo-activated compounds, lice treatments, cosmetic preparations such as scalp dye, hair dye, hair gel, conditioner, moisturizer, scalp oils, hair “volumizers,” vitamins, minerals, herbals, therapeutic water, zinc, iron, biotin, folic acid, anti-androgens, tretinoin, azelaic acid, and saw palmetto. The preparations may be provided in liquids of various viscosity, or in foams or other fluids, slurries or suspensions. Thus, while the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. Other embodiments and configurations may be devised without departing from the spirit of the inventions and the scope of the appended claims.

Claims

1. A device for applying a hair-regrowth topical solution to the scalp of a user, said device comprising:

a manifold sized and dimensioned to cover a portion of the scalp, said manifold having a interior surface adapted to appose the scalp and an outer surface, and a plurality of nozzles depending from the interior surface of the manifold, and a fluid inlet port;

a moisture barrier disposed about the manifold, said moisture barrier sized to cover a portion of the scalp;

said manifold and moisture barrier shaped to fit over the scalp of the user.

2. The device of claim 1 further comprising:

an occlusive seal disposed about the manifold and adapted to engage and encircle a portion of the scalp.

3. The device of claim 1 further comprising:

an ornamental cap for housing the manifold, and moisture barrier, wherein the manifold is secured to the inside of the cap and the fluid inlet port protrudes from the inside of the cap to the exterior of the cap.

4. The device of claim 3, wherein the inlet port protrudes from the crown of the cap.

5. The device of claim 4, wherein the cap comprises a baseball cap, and the inlet port protrudes from the crown of the cap.

6. The device of claim 1 wherein the manifold comprises a bowl-shaped manifold.

7. The device of claim 1 wherein the manifold comprises a plurality of manifold arms extending radially from a central plenum, and the inlet port is disposed proximate the central plenum.

8. A system for applying a hair-regrowth topical solution to the scalp of a user, said device comprising:

an moisture barrier disposed about the manifold, said moisture barrier sized to cover a portion of the scalp;

said manifold and moisture barrier shaped to fit over the scalp of the user;

a source of hair-regrowth topical solution in fluid form for injection into the manifold.

9. The system of claim 8 further comprising:

an occlusive seal disposed about the manifold and adapted to encircle a portion of the scalp.

10. The system of claim 8 further comprising:

an ornamental cap for housing the manifold, and moisture barrier, wherein the manifold is secured to the inside of the cap and the fluid inlet port protrude from the inside of the cap to the exterior of the cap.

11. The system of claim 8, wherein the inlet port protrudes from the crown of the cap.

12. The system of claim 8, wherein the cap comprises a baseball cap, and the inlet port protrudes from the crown of the cap.

13. The system of claim 8 wherein the manifold comprises a bowl-shaped manifold.

14. The system of claim 8 wherein the manifold comprises a plurality of manifold arms extending radially from a central plenum, and the inlet port is disposed proximate the central plenum.

15. The system of claim 8 wherein the reservoir comprises a bladder pump adapted for connection to the inlet port.

16. The system of claim 15 wherein the reservoir comprises a bladder pump adapted for connection to the inlet port, said bladder pump sized to hold a single dose of hair-regrowth topical solution.

17. The system of claim 15 wherein the reservoir comprises a bladder pump adapted for connection to the inlet port, said bladder pump sized to hold a single dose of hair-regrowth topical solution, and a multi-dose reservoir, wherein said bladder pump includes an inlet port adapted to connect to the multi-dose reservoir.

18. A method of treating hair loss comprising:

providing a manifold adapted to fit over the scalp of a patient, said manifold having an inlet for the injection of a hair-regrowth topical solution, a plurality of nozzles providing for drainage of the hair-regrowth topical solution from the manifold;

placing the manifold over the scalp of the patient and injecting the hair-regrowth topical solution onto the scalp through the manifold and nozzles to apply an effective amount of the hair-regrowth topical solution to the scalp of the patient.

19. A method of claim 18 further comprising:

providing a moisture barrier adapted to fit over the scalp of the patient, and holding the vapor barrier over the scalp for a period after application effective to enhance absorption of the hair-regrowth topical solution by the scalp.

20. A method of claim 18 further comprising:

providing an ornamental cap to house the manifold.

21. A method of claim 18 further comprising:

providing the hair-regrowth topical solution in a plurality of single dose reservoirs, each of said single dose reservoirs sized to hold an amount of the hair-regrowth topical solution sufficient to apply an effective dose of the hair-regrowth topical solution to the scalp through the manifold.

22. A device for applying a prophylactic hair maintenance preparation to the scalp of a user, said device comprising:

said manifold and moisture barrier shaped to fit over the scalp of the user.

23. The device of claim 22 further comprising:

24. The device of claim 22 further comprising:

25. The device of claim 24, wherein the inlet port protrudes from the crown of the cap.

26. The device of claim 25, wherein the cap comprises a baseball cap, and the inlet port protrudes from the crown of the cap.

27. The device of claim 22 wherein the manifold comprises a bowl-shaped manifold.

28. The device of claim 22 wherein the manifold comprises a plurality of manifold arms extending radially from a central plenum, and the inlet port is disposed proximate the central plenum.

29. A system for applying a prophylactic hair maintenance preparation to the scalp of a user, said device comprising:

said manifold and moisture barrier shaped to fit over the scalp of the user;

a source of prophylactic hair maintenance preparation in liquid form for injection into the manifold.

30. The system of claim 29 further comprising:

31. The system of claim 29 further comprising:

32. The system of claim 29, wherein the inlet port protrudes from the crown of the cap.

33. The system of claim 29, wherein the cap comprises a baseball cap, and the inlet port protrudes from the crown of the cap.

34. The system of claim 29 wherein the manifold comprises a bowl-shaped manifold.

35. The system of claim 29 wherein the manifold comprises a plurality of manifold arms extending radially from a central plenum, and the inlet port is disposed proximate the central plenum.

36. The system of claim 29 wherein the reservoir comprises a bladder pump adapted for connection to the inlet port.

37. The system of claim 36 wherein the reservoir comprises a bladder pump adapted for connection to the inlet port, said bladder pump sized to hold a single dose of prophylactic hair maintenance preparation.

38. The system of claim 36 wherein the reservoir comprises a bladder pump adapted for connection to the inlet port, said bladder pump sized to hold a single dose of prophylactic hair maintenance preparation, and a multi-dose reservoir, wherein said bladder pump includes an inlet port adapted to connect to the multi-dose reservoir.

39. A method of treating hair loss comprising:

providing a manifold adapted to fit over the scalp of a patient, said manifold having an inlet for the injection of a prophylactic hair maintenance preparation, a plurality of nozzles providing for drainage of the prophylactic hair maintenance preparation from the manifold;

placing the manifold over the scalp of the patient and injecting the prophylactic hair maintenance preparation onto the scalp through the manifold and nozzles to apply an effective amount of the prophylactic hair maintenance preparation to the scalp of the patient.

40. A method of claim 39 further comprising:

providing a moisture barrier adapted to fit over the scalp of the patient, and holding the vapor barrier over the scalp for a period after application effective to enhance absorption of the prophylactic hair maintenance preparation by the scalp.

41. A method of claim 39 further comprising:

providing an ornamental cap to house the manifold.

42. A method of claim 39 further comprising:

providing the prophylactic hair maintenance preparation in a plurality of single dose reservoirs, each of said single dose reservoirs sized to hold an amount of the prophylactic hair maintenance preparation sufficient to apply an effective dose of the prophylactic hair maintenance preparation to the scalp through the manifold.