Abstract:
A heat sealing instrument for use in the treatment and prevention of hair loss and stimulation of new hair includes a heating element, a protective shroud, a handle, and control circuitry. The heating element is heated to a temperature of from about 400 to about 1,000° F. sufficient for fusing and sealing the cuticle, cortex, and medulla layers of a hair shaft. The instrument includes a control panel for monitoring and adjusting the temperature of the heating device and a vacuum source and filter combination for drawing in and filtering the fumes from the area around the heating element.

Description:
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/276,591 entitled, “APPARATUS FOR TREATMENT AND PREVENTION OF ALOPECIA”, by Steven L. Ringler et al., filed Mar. 16, 2001, the entire disclosure of which is hereby incorporated herein by reference. 

   FIELD OF THE INVENTION 
   The present invention relates generally to the treatment and prevention of human or animal alopecia conditions and more specifically to an apparatus for use in treatment of the same. 
   BACKGROUND OF THE INVENTION 
   It is estimated that 35 million Americans experience some degree of alopecia, or hair loss, resulting in 900 million dollars a year being spent in efforts to grow it back. Generally, it affects about 30 million men and 20 million women in the U.S. each year. It is believed that baldness is hereditary and occurs when the hair follicles slowly begin to produce finer and shorter hairs, or stop producing hairs at all. There are many forms of hair loss, ranging from alopecia areata to androgenic alopecia, also known as male or female pattern baldness. 
   Around 40% of men will have some hair loss by their mid 30&#39;s, and nearly 60% of women experience some thinning of the hair after menopause. By age 50, half of all males generally experience hair loss patterns as compared to 50-70% of post-menopausal women. Alopecia becomes more common as age increases, but hair loss may start at younger ages. Without drug therapy or cosmetic treatments, alopecia can remain as a permanent condition. 
   In addition, animals can also suffer from a variety of dermatologic conditions. Such conditions frequently cause stress to the animal&#39;s haircoat resulting in hair loss, which further exacerbates an increased health risk to the animal and increased concern to the pet owner. Common examples of dermatologic conditions of animals, which can result in hair loss, include sebaceous adenitis, primary seborrhea, primary idiopathic seborrhea, seasonal alopecia, and other miscellaneous dermatoses. 
   To treat human alopecia, the prior art has produced an enormous variety of drug and cosmetic treatments. The reason for such a volume of treatment options stems from the difficulty the medical and scientific community have had in establishing the cause of alopecia. Alopecia has many possible causes, such as genetic disorders, infections, contact with toxic agents, and hormone imbalance. Currently, there are only two drugs approved by the Food and Drug Administration to treat alopecia. 
   Rogaine®, also known as minoxidil, was originally developed as a treatment for individuals with high blood pressure. While treating those individuals, it was discovered that minoxidil also moderately increased hair growth and prevented future hair loss. It is believed that minoxidil may increase hair growth in thinning hair areas. However, there are problems associated with the use of minoxidil. The most common problems are irritation of the skin, and if the medication is stopped after prolonged use, hair loss may actually increase rather than decrease. Further, major complications of minoxidil are rare, but possible, and patients who suffer from heart disease or hypertension cannot utilize this product without medical supervision. 
   The other approved product to treat alopecia is Propecia®, or finasteride. Propecia® originally was used to treat prostate enlargement by inhibiting the 5-alpha reductase enzyme. Men undergoing that treatment experienced an increase in hair growth while receiving finasteride. It is believed that the inhibition of the 5-alpha reductase enzyme may increase hair follicle growth or prevent future hair follicle loss. However, pregnant or nursing women may not use finasteride because the product is teratogenic, and can harm the human fetus. Due to such a serious health risk, Propecia® has been limited to use within male patient populations only, leaving a majority of female alopecia sufferers to seek alternative treatment options. 
   Because of the downfalls of currently approved drug therapies for the treatment and prevention of human alopecia conditions, cosmetic treatments have been developed as well. One cosmetic treatment, as noted within U.S. Pat. No. 4,999,187 to Vernon, discloses a hair and scalp treatment composition that comprises 60% by weight or more of petrolatum in combination with 5% by weight or more sulfur, 0.5% by weight or more of 1,2,3-propanetriol, and the remaining 0.5 to 10% of the composition comprised of an oil, such as coconut oil. The composition is said to treat the hair and scalp to effectively prevent dandruff in the hair while conditioning and causing the hair to grow in areas of the scalp where it had previously ceased to grow. However, the &#39;187 patent does not disclose the use of its composition for a variety of alopecia conditions such as alopecia areata. Rather, the &#39;187 patent merely addresses the conditioning of the hair and scalp. 
   Another cosmetic treatment involves implanting synthetic or artificial hair into hair follicle root bulbs of the scalp, or implanting expandable balloon structures under the scalp, to stimulate natural hair growth. However, it has been found that artificial hair implant methods are almost always unsuccessful. Such implants often become infected, leading to increased patient health risk and further natural hair follicle loss. In response to the failure of artificial hair transplants, other implant treatments utilizing human hair have been developed. Of human transplants available, four invasive surgical methods are currently preferred within the medical community. 
   The first of those surgical methods includes hair grafts, in which a graft of a small area of hair bearing scalp is moved from one area of the head to another. Alopecia or bald areas are replaced with hair bearing scalp tissue grafts to allow for development of new, natural hair in the transplanted area. However, when such a graft is moved from one area of the scalp to another area, it loses its blood supply, and must reestablish a new one. If a new blood supply cannot be reestablished upon placement of the graft or if infection occurs, this surgical method will fail, resulting in no new hair growth, only scarred tissue. 
   An alternative surgical method is the hair flap, in which a piece of scalp along with its blood supply is moved from one location on the head to another. This method generally is used only when large areas of hair bearing scalp need to be moved, and the procedure involves a lengthy recovery time. For those seeking a less invasive and shorter recovery time, excision or scalp reduction has been developed. Excision or scalp reduction involves removing the hairless scalp tissue areas and stretching the remaining non-hairless scalp to cover the defect. Here again, the patient is subjected to a surgical procedure with its inherent risks and complications. 
   The last cosmetic surgical treatment method for hair loss involves tissue expansion, in which small balloons are placed beneath the hair bearing scalp, and the balloons are then expanded slowly over several weeks to stretch the adjacent area of the scalp intended to be used to cover the defect. This method again, has surgical risks and complications including scarring, as well as a lengthier treatment and recovery period due to the length of time needed to stretch the existing scalp tissue and for the incisions to heal. 
   Although surgical cosmetic treatments for alopecia are available, many problems exist with such treatment options. The main problems specifically associated with all of these methods are the need for multiple operations, scarring when the scalp is moved or stretched, unexpected results, and development of numbness in the scalp following the surgical procedure. Further, the patient is subjected to the risks of surgery in general, as well as swelling, bruising, bleeding, and infection during the recovery process. 
   More than 40 U.S. and several hundred foreign patents have been issued for hair loss/alopecia treatment methods and compositions. Yet, no single agent or method of treatment has been found to universally work against all forms of hair loss. Thus, the treatment process is often one of trial and error, leaving the patient searching for the treatment that will produce the desired result for them. 
   There is a need in the prior art for a composition and method of treatment regimen for the treatment and prevention of a variety of human alopecia conditions that are non-invasive, can be used in male and female treatment populations without reproductive risk, and can prevent future hair follicle loss while stimulating new hair follicle growth. In addition, there is a need within the prior art for a composition and method of treatment regimen for the treatment and prevention of a variety of animal alopecia conditions to maintain and stimulate a healthy haircoat upon the animal&#39;s skin. 
   SUMMARY OF THE INVENTION 
   In commonly owned U.S. Provisional Patent Applications Nos. 60/190,286 and 60/194,322, a method is disclosed for treating or preventing human or animal alopecia conditions by cutting the hair, heat sealing the cut ends, and applying a heated oil composition of preferably at least about 50% coconut oil either before or after the cutting and sealing steps. 
   The present invention is a hand-held device which is novel and facilitates the heat-sealing step in the treatment described above. A handle supports a heating element, and a protective shroud encloses the heating element thereby shielding a patient from accidental contact with the high temperature heating element. An aperture in the shroud permits hair to enter the shroud where it is heat-sealed by the heating element. The aperture is of sufficient size to allow hair to enter, yet is designed to minimise the risk of the patient&#39;s skin contacting the hot components inside the shroud. 
   In another aspect of the invention a vacuum source is provided to draw fumes away form the proximity of the heating element of a hand-held heating device. This is effective in drawing away fumes created as hair is sealed by the heating element. 
   These and other features, advantages and objects of the present invention will be further understood and appreciated by those skilled in the art by reference to the following specification and claims. A more detailed description of the present invention shall be discussed further below. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The present invention will now be described, by way of example, with reference to the accompanying drawings, in which: 
       FIG. 1  is a drawing of the hand piece of the invention illustrating much of the internal structure of the hand piece. 
       FIG. 2  is an exploded view of the hand piece. 
       FIG. 3  is a perspective view of the hand piece. 
       FIG. 4  is a block diagram of the invention. 
       FIG. 5  is a block diagram of a temperature controller. 
   

   DESCRIPTION OF THE PREFERRED EMBODIMENT 
   In the preferred embodiment, the instrument includes a hand-held device having a heating element, a protective shroud, and a handle. The hand-held device is connected to a control unit that provides electrical power to the heating unit and to a vacuum source that draws fumes from the area around the heating element. The heating element is heated to a temperature of from about 400° F. to about 1,000° F. sufficient for fusing and sealing the cuticle, cortex, and medulla layers of a hair shaft. The instrument is preferably used after the hair has been cut and either before or after the oil treatment has been applied. The operator sets the heating element to a desired temperature, grips the handle of the hand-held device, and maneuvers the heating element to contact the target hair. 
   In the preferred embodiment, the heating element is enclosed inside a polished chrome plated copper sheath that is thermally coupled to the heating element. The sheath, not the heating element, then contacts the hair to perform the heat-sealing process. 
   When the hand-held device is in use, various fumes are produced including smoke. An air channel runs through the interior of the hand-held device from the butt of the handle to near the heating element. The butt of the hand-held device is connected to the vacuum source thereby drawing fumes from the proximity of the heating element, through the handle, and through an air hose to the vacuum source. As part of the vacuum process, the fumes and air are filtered. 
   Turning to  FIG. 1 , the hand-held device  10  of the invention is illustrated in a semi-transparent depiction such that many of the elements are shown assembled together. Hand-held device  10  includes heating element  11 , sheath  12 , shroud  13 , shroud aperture  13 A, guard  14 , and handle  15 . Also illustrated are air hose  16  and electrical cable  17  that connect to the butt  10 A of hand-held device  10 . 
   Heating element  11  is a 100 watt resistive type heating element well known to those skilled in the art. The preferred embodiment operates on 24 volts AC and includes a type K thermocouple type heat sensor built into heating element  11 . Four wires exit the base of the heating element; two wires for providing electrical power and two wires for the temperature signal from the thermocouple. In the prototype, heating element is approximately ⅜ inch in diameter and 5{fraction (5/16)} inch in length. 
   Heating element  11  is secured to hand-held device  10  by a hollow cylindrical copper sheath  12 . Heating element  11  is positioned inside of sheath  12  which is then threading onto the retainer (not shown) component of hand-held device  10  as illustrated below. Sheath  12  has a polished chrome finish and is thermally coupled to heating element  11  via a thermally conductive paste filling the gap between heating element  11  and the interior of sheath  12 . Other surfaces may also be used for sheath  12 . For example, it is envisioned that polished metal surfaces, fluoropolymer resins (i.e. TEFLON®), cooking surfaces, and the like will also work well. In the prototype, sheath  12  is approximately ⅝ inches in diameter and 6¼ inches in length. 
   Sheath  12  and heating element  11  are both positioned inside of shroud  13 . Shroud  13  is a substantially hollow cylindrical shaped protective device intended to shield a patient from the high temperatures of heating element  11  and sheath  12 . These elements may reach a temperature of about 1,000° F. and can easily burn a patient. Shroud  13  is made of aluminium with a porcelain power coating. A heating element cavity  13 B includes the hollow area inside of shroud  13  and houses sheath  12  and heating element  11 . Hair-inlet aperture  13 A is located on the side of shroud  13  and is sized and shaped to allow hair to enter the heating element cavity  13 B while preventing a firm surface (e.g. a patient&#39;s scalp) from contacting the high temperature sheath  12  or heating element  11 . In alternate embodiments, such as shown in  FIG. 3 , hair-inlet aperture  13 A is comprised of multiple apertures. Shroud  13  threads onto other components of the hand-held device  10  as discussed below. 
   Adjacent to the base of shroud  13  is guard  14 . Guard  14  is another safety/protective feature of the invention that protects the hand of an operator from shroud  13 . Even though shroud  13  is generally cooler than heating element  11 , it may still be hot enough to burn or to be uncomfortable. Guard  14  is made of high temperature plastic such as garolite and insulates the operator from shroud  13 . Guard  14  is secured to handle  15  and has a large guard cavity  14 A which allows it to extend over the base of shroud  13  without touching shroud  13 . 
   Continuing along  FIG. 1 , an operator grips the hand-held device  10  via handle  15 . Handle  15  includes a plastic frame  15 A (see  FIG. 2 ) surrounded by a neoprene rubber cover  15 B and an end cap  15 C. The plastic frame  15 A is substantially hollow and provides a channel for the electrical wires  17  that connect to the heating element  11  and for airflow from the area around heating element  11  to air hose  16 . Both the electrical wires  17  and the air hose  16  connect to handle via end cap  15 C which threads onto frame  15 A. 
   Air hose  16  is preferably made of a high quality plastic that is able to withstand elevated temperatures. It was found during testing, that a small diameter air hose would become overheated as hot air from the heater element  11  was drawn through the hose. The solution was to increase the diameter of air hose  16  for increased airflow and to use heat tolerant materials. Air hose  16  attaches to hand-held device  10  via coupling  16 A. 
   Electric wires  17  are preferably a high quality electric cable having a braided wire mesh covering the wires. The wire mesh is coated in plastic or similar material and yields a preferred electric cable for the invention. 
   Referring to  FIG. 2  there is shown an exploded view of the hand-held device  10  that shows the components in more detail. Beginning at the bottom of the drawing, shroud  13  threads onto adapter  21  via shroud threads  13 C and front adapter threads  21 A. This arrangement allows a user to easily remove and clean device  10  as needed. Heating element  11  is inserted into sheath  12 , and sheath  12  threads into retainer  23 . Ceramic bobbin  22  is clamped between sheath  12  and retainer  23  when sheath  12  and retainer  23  are threaded together. Bobbin  22  has a hole through its center for receiving retainer  23 . However, the hole is smaller diameter than the ridge on the base of sheath  12  and bobbin  22  is thereby secured to retainer  23  and sheath  12 . Bobbin  22  also provides additional channels for wire  17  from heating element  11  and for airflow drawn from the area proximate to heating element  11 . Bobbin  22  serves to insulate the other components from heating element  11 . 
   When sheath  12  is secured to retainer  23 , a rigid unit is created comprising the retainer  23 , bobbin  22 , heating element  11 , and sheath  12 . This unit is inserted into adapter  21  with sheath  12  extending into the heating element cavity  13 B of shroud  13 . Adapter  21  is preferably made of aluminium, while retainer  23  is made of steel and bobbin  22  is ceramic. 
   Continuing with the assembly of the hand-held device  10 , the handle frame  15 A is treaded onto adapter  21  via rear adapter threads  21 B and front frame threads  15 F. This secures all of the prior assembled components into a rigid unit. Guard  14  is slid onto the rear  15 D of frame  15 A and slide forward along handle frame  15 A until it stops and guard cavity  14 A substantially surrounds the retainer  23 , bobbin  22 , and the base of shroud  13 . Plastic handle frame  15 A can still get warm from the hot air drawn through its hollow interior; therefore neoprene rubber cover  15 B is slid onto handle frame  15 A to provide insulation and a good gripping surface. End cap  15 C is then secured to handle frame  15 A via two screws threaded into screw holes  15 E. The rear of end cap  15 C forms the butt  10 A of and hand-held device  10 . Air hose  16  connects to end cap  15 C via connector  16 A and electrical wires  17  enter end cap  15 C. 
   Turning to  FIG. 3  there is shown a perspective view of hand-held device  10  that also illustrates some alternate embodiments of the invention. An embodiment having multiple hair inlet apertures  13 A is shown. Multiple hair inlet apertures may provide better protection against burn injury to a patient; however, it restricts access of hair to the heating element. Another embodiment equips shroud  13  with teeth  13 C that function as a comb and are useful in some applications. 
   Looking now to  FIG. 4 , a block diagram of the apparatus is shown. A power source (not shown) provides 115VAC power  40  to medical isolation transformer  41  and vacuum source  42 . Medical transformers are often required to power medical devices and are well known in the art. Although it is not required for the operation of the invention, the medical transformer  41  is included to insure compliance with generally accepted standards. Medical transformer  41  provides an isolated 24VAC-power signal  41 A to temperature control  43 . Power signal  41 A is used by temperature control  43  to power heating element  11 . 
   Temperature control  43  controls the temperature of heating element  11 . The prototype unit uses a conventional temperature controller such as the PC Programmable Thermocouple Sensing Temperature Controller, model number 5C7-461, manufactured by Oven Industries of Mechanicsburg, Penn. The Operating Manual for the controller is herein incorporated by reference. Those skilled in the art understand that many such temperature control circuits and devices are available and known. The 115VAC signal  41 B provides power to temperature control  43 . 
   The operation of temperature control  43  is straightforward. An operator enters a desired temperature via user interface  44 . User interface  44  generates a temperature command signal  44 A representative of the desired temperature and communicates command signal  44 A to temperature control  43 . The current temperature of heating element  11  is unknown, so temperature signal  45 A is communicated from temperature sensor (e.g. thermocouple)  45 . Temperature signal  45 A provides the feedback data used by temperature control  43  to accurately control the temperature of heating element  11 . 
   In the preferred embodiment, command signal  44 A is simply resistance from one of three potentiometers or variable resisters  44 B in user interface  44 . Each potentiometer  44 B has a different resistance range and therefore each potentiometer  44 B generates a different temperature command signal. The desired potentiometer is selected using a three-way switch  44 C. 
   Alternate embodiments include, for example, implementing a digital user interface which would generate a digital command signal  44 A instead of an analog resistance type signal. Also, thermocouple  45  can be any type of suitable temperature sensor. 
   Temperature control  43  controls electrical power signal  43 A to heating element  11  as a function of command signal  44 A from user interface  44  and feedback temperature signal  45 A from thermocouple  45 . Temperature control  43  communicates a status signal  43 B back to user interface  44  which activates one of three lights  44 D,  44 E and  44 F thereby indicating if the measured temperature is above, at, or below the commanded temperature. Lamp  44 D is activated if the actual temperature is above the commanded temperature. Similarly, lamp  44 F is activated if the actual temperature is below the commanded temperature. If the actual temperature is within a predetermined range specified by the command signal  44 A, then lamp  44 E is activated. Power switch  44 G switches power signal  40  on and off to components of control unit  46 . 
   Temperature control  43  controls the temperature of heating element  11  to between about 400° F. to about 1,000° F., preferably between about 600° F. to about 1,000° F., and more preferably between about 800° F. to about 1,000° F. 
   Vacuum source  42  is any device capable of drawing a sufficient volume of air through hand-held device  10  to draw fumes from around heating element  11 . Vacuum sources are well known in the art. Vacuum source  42  includes a filter  42 A for filtering the fumes and particles drawn in by the vacuum source  42 . It is preferred to use a high efficiency HEPA filters because of their excellent filtering characteristics. However, other filters may be adequate under certain conditions. 
   A block diagram of temperature control  43 , model number 5C7-461 manufactured by Oven Industries, is shown in  FIG. 5  connected to other elements of the apparatus. Load or heating element  11  is shown with one lead connected to pin WP 1  and a second lead connected to 24 VAC power signal  41 A. The circuit is completed when power signal  41 A is connected to pin WP 2 . Control  43  controls the power to heating element  11  via a relay internal to control  43 . Power is provided to temperature control  43  via 115 volts alternating current (VAC) signal  41 B which connects to pins WP 8  and WP 4 . Potentiometers or variable resisters  44   b  connect to pins  3 ,  4 , and  5  of connector JP 1 . The temperature signal  45 A from thermocouple  45  connects to pins  7  and  8  of connector JP 1 . Temperature controller  43  can be connected to a personal computer or the like in order for a user to set or modify parameters. For example, a user can program the desired control algorithm parameters such as proportional (P), integral (I), and derivative (D), or various combinations of P, I, and D. In the alternative, an ON/OFF mode may be selected with hysteresis. 
   The hair treatment instrument of the present invention performs the heat sealing process for a method of treating alopecia. The instrument effectively heat-seals the hair of a patient and disposes of fumes generated from the process. 
   It will be understood by those who practice the invention and those skilled in the art, that various modifications and improvements may be made to the invention without departing from the spirit of the disclosed concept. The scope of protection afforded is to be determined by the claims and by the breadth of interpretation allowed by law.