Abstract:
An apparatus for producing medical foam for wound care or hair stimulation has a foam generation unit including a fluid reservoir, a fluid delivery line and a foam generation tip. The apparatus also includes a compressed gas unit having at least one container of compressed gas, a source of electric power, and a gas regulator valve. A supply of wound care or hair stimulating solution is communicably connected to the foam generation tip such that when the apparatus is operated medical foam is produced by the foam generator tip.

Description:
RELATED APPLICATION 
       [0001]    This application is a continuation in part of U.S. patent application Ser. No. 12/652,845 filed Jan. 6, 2010, which claims the benefit of U.S. patent application Ser. No. 12/210,368 filed Sep. 15, 2008, which claims the benefit of U.S. patent application Ser. No. 11/945,674 filed Nov. 27, 2007, which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/867,323 filed Nov. 27, 2006, the disclosures of which are incorporated herein by reference in their entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to an apparatus and process for producing CO 2  enriched medical foam for use in wound care and hair growth stimulation. 
       BACKGROUND OF THE INVENTION 
       [0003]    The present invention utilizes the Venturi effect to produce medical grade foam comprising CO 2  for use in applications such as wound care and hair growth stimulation. The apparatus of the present invention is simple to manufacture and use because it does not require an impeller and incorporated fan with a foam generator in order to create and dispense the foam. 
         [0004]    The Venturi effect is an example of Bernoulli&#39;s principle, in the case of incompressible fluid flow through a tube or pipe with a constriction in it. The fluid velocity must increase through the constriction to satisfy the equation of continuity, while its pressure must decrease due to conservation of energy: the gain in kinetic energy is supplied by a drop in pressure or a pressure gradient force. 
         [0005]    The limiting case of the Venturi effect is choked flow, in which a constriction in a pipe or channel limits the total flow rate through the channel because the pressure cannot drop below zero in the constriction. Choked flow is used to control the delivery rate of water and other fluids through spigots and other types of valves. The portable apparatus of the present invention utilizes a source of compressed gas, namely CO 2 , to produce the desired pressure and airflow for the effective creation of medical foam, which foam is, in turn, used for wound care and hair growth stimulation. To date, medical foam has been used strictly in sclerosing applications, wherein blood vessels are destroyed. Medical foam has not been previously utilized in wound therapy or hair growth techniques wherein cell growth is encouraged. CO 2  enriched foam has certainly not been put to such uses. 
       SUMMARY OF THE INVENTION 
       [0006]    The present invention provides for a novel apparatus for producing medical foam as well as a process for utilizing such foam in wound care and hair growth applications. One embodiment in the present invention features an apparatus for producing medical foam comprising (i) a foam generation unit having a fluid reservoir, a fluid delivery line and a foam generation tip; and (ii) a compressed gas unit having at least one container of compressed gas, a source of electric power and the gas regulator valve. 
         [0007]    The fluid reservoir contains a medical solution for producing the foam. The compressed gas is any suitable compressed gas. Suitable compressed gases may preferably include carbon dioxide, atmospheric air, helium, or mixtures thereof. The compressed gas is contained in one or more compressed gas containers. The apparatus has a source of electric power that may be delivered by batteries providing between about 3-24 volts. The apparatus also has a foam generation tip that includes a membrane providing a surface for the formation of medial foam. In a preferred embodiment, the gas regulator valve is an electronically activated solenoid. Additionally preferred, the gas regulator valve is an electronically activated solenoid controlled by a pressure activation switch or actuator. The pressure switch activates the solenoid when depressed. 
         [0008]    In one embodiment, the present invention utilizes an air delivery system whereby the air is delivered by compressed gas. Any compressed gas can be used. Preferably, the compressed gas is selected from compressed ambient air, carbon dioxide, helium, oxygen, or combinations thereof. Carbon dioxide is especially preferred for using the medical foam produced by the apparatus in wound treatment and hair growth stimulation. 
         [0009]    In another embodiment, the apparatus of the present invention includes compressed air storage, with a hose or other acceptable transport mechanism to deliver the compressed gas to the foam generation tip or any other receptacle. The foam generation tip includes a novel arrangement by which compressed air enters a first end of the foam generation tip through an air inlet. The resultant pressure produced within the foam generation tip draws medical solution into the interior of the tip through a second inlet. The compressed air continues to travel towards the second end of the foam generation tip onto which a membrane is affixed. The membrane provides a surface at which the medical solution mixes with the compressed air and the medical solution foams. The compressed air passes through the membrane and lifts the foams off the membrane outward from the foam generation tip. Thus, the solution, now foamed by the compressed gas, can be delivered and applied to a wound or area of the body where hair growth is desired. 
         [0010]    In another embodiment, a user will utilize two separate units of the apparatus wherein a first unit includes at least one compressed air cylinder and a valve for controlling the release of compressed air from the cylinder. In one embodiment, the valve for controlling the release of compressed air is an electronic solenoid. 
         [0011]    The present invention also relates to methods of medical treatment. In one embodiment the invention is a method for providing CO 2  enriched foam and applying such foam to a wound comprising the steps of: (i) providing a portable CO 2  apparatus, (ii) providing a container with a medical solution, the container having an entrance, an exit and a release means regulating the exit; (iii) attaching a medically acceptable directional device from the apparatus to the entrance of the container; (iv) initiating an actuator of the apparatus to release CO 2 ; (v) activating the release means to produce a medical foam containing CO 2 ; and (vi) applying the medical foam to a wound to attract oxygen to the wound and thereby promote healing. In medical uses, CO 2  is used because it is safer and has less complications than air or oxygen in the same uses. CO 2  diffuses more naturally in body tissues and is absorbed in the body more rapidly and with less side effects. Medical foam produced in this manner may alternatively be applied to a skin surface of the human body to stimulate hair growth. 
         [0012]    In a preferred embodiment, the CO 2  gas that is expelled from the apparatus will ultimately be used for foaming of medical solutions to produce a CO 2  enriched foam for the healing of ulcerations. These solutions may include, but would not be limited to saline, aloe, Amerigel®, microbial agents, and surfactants. CO 2  is used to aerate the solution and subsequently produce a medical foam for particular use in the field of wound and ulceration treatment. CO 2  enriched foam with the addition of medically appropriate solutions and surfactants will aid in the debridement of a wound, as well as, more efficient and more rapid healing of the affected area by drawing oxygen to that area. 
         [0013]    The apparatus used in the present invention is portable, compact, and electronic, which makes it convenient for various portable medical uses including military field use. The apparatus is also well suited for any other use requiring CO 2  for its performance, such as compartmentalization, aid in ulcer healing, and aid in increasing follicle hair stimulation to promote hair growth. The apparatus of the present invention can also be adapted for dispensing other gases under the same nature, such as oxygen, helium, or any other gas needed to be contained in a compact, portable delivery system. In a preferred embodiment, the present invention is completely battery operated. 
         [0014]    The invention can be used to provide CO 2  or like gases to one syringe, two syringes with a stopcock connector, or any container that can house or store the CO 2  before using it to aid in ulcer healing, and/or in increased follicle hair stimulation to aid in hair growth. 
         [0015]    The invention can deliver CO 2  from an adjustable port that controls the psi from 0 psi to 120 psi. 
         [0016]    Previous methods utilizing large CO 2  tanks and regulators are dangerous because of the risk of a seal, valve, or part malfunction causing a projectile in a medical setting. The present invention is safer as it eliminates this possibility of malfunction. 
         [0017]    The invention requires very little space to store, as opposed to the cumbersome existing tank systems and is much easier to use, with a push button actuator to initiate operation. The present invention is much less expensive than current CO 2  tank systems. 
         [0018]    Acquisition of the CO 2  in the present invention now requires only cartridges which can be delivered in a small box. The current tanks require filling at a filling station which involves the transport of a large quantity of CO 2  which could also result in an explosion in the event of a motor vehicle crash. 
     
    
     
       DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
         [0019]    Other objects, features and advantages will occur from the following description of a preferred embodiment and the accompanying drawings, in which: 
           [0020]      FIG. 1  is a side perspective and partly schematic view of an apparatus including compressed gas (CO 2 ) cylinders and a solenoid of the present invention; 
           [0021]      FIG. 2  is a perspective view of the foam generating tip and medical solution reservoir; 
           [0022]      FIG. 3  is a close-up view of the foam generating tip shown in  FIG. 2 ; 
           [0023]      FIG. 4  is a schematic front view of an alternative compressed gas unit enclosed in a housing; 
           [0024]      FIG. 5  depicts a schematic layout of the components of the compressed gas unit of  FIG. 4 . 
       
    
    
       [0025]    In  FIG. 1  compressed gas unit  1  comprises solenoid  55  with at least one compressed gas (CO 2 ) cylinder  27 . In one embodiment, compressed gas cylinder  27  is 25 g or larger. Compressed gas cylinder  27  is secured into position to unit  1  by means of cylinder cartridge puncture valve  26  and a fitting  74 . In a preferred embodiment, cylinder cartridge puncture valve  26  has a mechanism for piercing cylinder  27 , as is known, and holding or securing said cylinder in place. Compressed air is delivered to solenoid  55  from compressed gas cylinder  27  through cylinder cartridge puncture valve  26  and a channel  73  of fitting  74 . Compressed gas unit  1  has at least one battery  65 , held in place by battery holder  42 , for providing electrical power by which solenoid  55  may be activated and then regulated by a pressure activation switch or actuator  37 . Battery  65  supplies power to solenoid  55  through switch wire assembly  23 , which is connected to activation switch  37 . This switch is mounted to a pressure nut  32  carried on threaded conduit  38 . Compressed air unit  1  has electrical wiring  39  for providing necessary electricity from switch  37  to solenoid  55 . Unit  1  also comprises a black rock regulator  140 , which is controlled by secondary regulator adjustment knob  30  when solenoid  55  is activated. Black rock regulator  140  is communicably connected to unit  1  by an elbow pipe  40 . The elbow pipe includes a threaded vertical conduit segment  41  joined to regulator  140  through a connector nut and a threaded horizontal conduit  38 , which is engaged by pressure nut  32 . 
         [0026]    Compressed gas cylinder  27  is secured to unit  1  by cartridge puncture valve  26  as is commonly known. In one embodiment, compressed gas cylinder  27  is a 25 g cylinder. Compressed air leaves black rock regulator  140  through a 10/32″ hose port  12   b  and flows through a hose junction  22 , by means of ⅛″ pressure hose  54 , until reaching the 10/32″ hose port  12  affixed to solenoid  55 . From hose port  12 , the compressed air enters solenoid  55 . Compressed air unit  1  also has an outlet air port  25 , which is connected to solenoid  55  through intermediate 10/32″ hose port  12   a  for transporting compressed gas, namely CO 2 , from solenoid  55  in compressed gas unit  1  to foam generation unit  2 , FIG. whenever the solenoid is opened. Outlet gas may be monitored with pressure gauge  52  connected to hose junction  22  through a conduit  45  having threads  46 . The threaded end of conduit  45  interengages a nut  48  carried by hose junction  22 . 
         [0027]    In certain embodiments a second compressed gas cylinder  28 , featuring a 12 g or 16 g compressed gas cylinder, may be used in addition to or in lieu of gas cylinder  27 . In still other embodiments a larger compressed gas cylinder and expansion chamber may be substituted for the gas cartridges previously described in accordance with the invention. The size and number of compressed gas containers are not limitations of the invention. 
         [0028]    In  FIG. 2 , a CO 2  enriched foam generating unit  2  features a micro hose  256  for receiving compressed gas from unit  1 . Compressed CO 2  leaving unit  1  via outlet air port  25  enters unit  2  via micro hose  256 . Compressed gas passes through air hose inlet  230  and enters a foam generation tip  280 . 
         [0029]    As shown in  FIG. 3  foam generation tip  280  also includes foam solution delivery line  225  that has an outlet  220  for delivering foam solution into upper chamber  240 . This solution may include any of various solutions such as, but not limited to various wound wash solutions, saline, aloe, microbial agents and surfactants which are appropriate for treating wounds and ulcerations. For example, Amerigel® solution may be effectively utilized as the foam solution. Solutions for stimulating hair growth include monoxidil marketed under the brand name Rogaine®. In a preferred embodiment, medical solution from solution reservoir  290 ,  FIG. 2 , travels up needle  241  and hub  246  when compressed gas enters tip assembly  280  through inlet  230  after being actuated and released from unit  1 . Compressed gas entering tip assembly  280  imparts negative pressure on solution in reservoir  290  and draws solution through needle  241  and into tip solution inlet  225  ( FIGS. 2 and 3 ) through hose  216  due to the Venturi effect. Stopcock  255  is used to regulate or stop flow of solution from reservoir  290 . Solution enters solution delivery line  225  from solution line  216 . Compressed gas traveling from lower chamber  235  to upper chamber  240  creates negative pressure inside the foam generation tip  280 , such that medical foam solution exiting outlet  220  mixes with compressed CO 2  and forms CO 2  enriched medical foam that forms on membrane  215 . The force of the compressed gas traveling through foam generation tip  280  and exiting through membrane  215  lifts medical foam/foams outward from membrane  215  and projects the foam into the foam dispensing port  270 . The medical foam then exits tip assembly  280  through syringe hub  260  and is directed onto a wound or ulceration requiring treatment. Specifically, CO 2  enriched foam may be applied directly to a wound or ulceration. The CO 2  attracts oxygen to the wound/ulceration, which promotes healing. This is an unexpected beneficial result as, to date, the use of medical foams has been largely limited to sclerotherapy wherein blood vessels/tissue are destroyed. CO 2  enriched foam produced in the foregoing manner may alternatively be used to stimulate hair follicle growth. 
         [0030]      FIGS. 4 and 5  depict an alternative embodiment of a compressed gas unit  1   a  wherein various components of the gas unit are enclosed in a housing  75 . The components of unit  1  a are designated by reference numerals that correspond to those of the previously described embodiment and further include “a” designations. In particular, a CO 2  cartridge  27   a  is connected by a puncture valve  26   a  to a regulator  140   a.  The regulator is controlled by an adjustment knob  30   a.  Regulator  140   a  is connected through a conduit  54   a  to both a pressure gauge  52   a  and a solenoid  55   a.  More particularly, gauge  52   a  is connected to a coupling  48   a.  Solenoid  55   a  is powered by a battery  65   a,  which is itself held in place within the housing by a holder  42   a.  A user accessible luer fitting  25   a  is communicably connected to solenoid  55   a  and extends exteriorly of housing  75   a.    
         [0031]    Unit  1   a  is activated to open solenoid  55   a  by engaging switch  37   a.  The compressed gas unit operates in a manner analogous to that previously described to provide compressed CO 2  from cartridge  27   a  through luer fitting  25   a  to an attached foam generating tip as depicted in  FIGS. 2 and 3 . 
         [0032]    From the foregoing it may be seen that the apparatus and method of this invention provides for a novel and beneficial means for wound care and hair growth treatment. While this detailed description has set forth particularly preferred embodiments of the apparatus of this invention, numerous modifications and variations of the structure of this invention, all within the scope of the invention, will readily occur to those skilled in the art. Accordingly, it is understood that this description is illustrative only of the principles of the invention and is not limitative thereof. 
         [0033]    Although specific features of the invention are shown in some of the drawings and not others, this is for convenience only, as each feature may be combined with any and all of the other features in accordance with this invention. 
         [0034]    Other embodiments will occur to those skilled in the art and are within the following claims: