Abstract:
Apparatus, method and system for delivering sterile unit dose of ozone. System includes sterile vial containing oxygen and corona discharge assembly. Sterile vial is engaged to ozone conversion unit having high voltage transformer, ozone measurement mechanism, data input mechanism, and displayed read-out. When power is supplied to sterile vial containing corona discharge assembly, oxygen is converted to specified concentration of ozone. Sterile vial is disengaged from ozone conversion unit, drawing port is attached, and needle or similar extraction tool is used to withdrawal ozone for treatment.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention generally relates to ozone delivery systems. More generally, the invention relates to those used to facilitate delivery of ozone for therapeutic purposes. 
       BACKGROUND 
       [0002]    Ozone is an unstable gas with a half life of less than one hour at room temperature. The methods used to convert oxygen to ozone involve high voltage corona discharge or ultraviolet light. Ozone generators have been available for decades for industrial uses. Indeed, ozone is a powerful oxidizer and has been used for deodorizing air, and purifying water. It is a known bactericide and viricide and recently has been used to sterilize medical instruments; although, the cycle times are so long as to be impractical for many uses. 
         [0003]    Ozone generators have been used for therapeutic applications for several years. Such applications include but are not limited to autohemotherapy, rectal insufflations, intradiscal injection and full body exposure. Ozone has also been used to treat diffuse bulging or contained herniation of the spinal disc. 
         [0004]    Spinal discs are composed of a fibrous outer ring made of Type I collagen and a softer more flexible nucleus made of Type II collagen, proteoglycans and water. Patients with disc bulging or herniation suffer from pain caused by disc compression of the neurological elements, including the spinal cord, cauda equina and nerve roots. Intradiscal ozone treatment involves direct injection of a gaseous mixture of oxygen and ozone into the nucleus of the disc. Ozone releases water from the proteoglycans, reducing disc size and relieving compression of neurological elements. Some investigators believe that ozone stimulates anti-inflammatory mediators and initiates a healing response. 
         [0005]    The mechanism of action and reported success rates of ozone treatment are similar to that of the enzyme chymopapain. Chymopapain was first FDA-approved in 1983 and was widely used with a success rate of 65-85%. A small number of serious complications, including death and paralysis, caused the product to lose favor in the market and the product was eventually discontinued in the United States. 
         [0006]    Ozone and chymopapain are two means of performing a chemical discectomy through a needle puncture. This minimally invasive approach may be preferred to surgical discectomy, which requires general anesthesia and direct access to the spinal disc. 
         [0007]    Therapeutic ozone must be delivered immediately after being produced. Existing medical ozone generators pass medical oxygen through an electric field or ultraviolet light. This process converts an amount of oxygen into ozone. A syringe is interfaced with the machine whereby ozone is withdrawn for subsequent use in chemical discectomy. 
         [0008]    The preferred concentration of ozone for this application is less than 6%. The concentration of ozone is important for medical uses. If the concentration is too low the treatment will not be effective; if the concentration is too high detrimental effects may follow. As such, medical ozone generators must include a means for measuring the concentration of ozone. The elements necessary to create and measure ozone are sensitive and require maintenance to ensure precise and accurate operation. 
         [0009]    Present ozone generators have basic means for controlling the concentration and delivery of ozone gas. Oxygen is generally passed through a machine containing permanent electrodes; the gas chambers of present generators are often permanent as well. Some generators include components that neutralize excess ozone. Others generators continuously vent ozone, while still others are self-contained within a syringe, offering little means for measuring or controlling the concentration of ozone gas. Present ozone generators often include components for gas containment or pass oxygen through reaction chambers that are permanent and reusable, lending to sterility issues. Medical professionals often inject the gas through a bacterial filter to address such sterility issues. 
         [0010]    Present generators are capable of offering a minimally invasive medical procedure to patients currently in need of surgical discectomy. Present generators lack an ozone delivery system that can efficiently provide sterile unit doses of ozone. Further, current systems lack the ability to ensure sterility and purity of the ozone dose, have high maintenance costs, fail to address problems associated with degradation of corona discharge mechanisms, and have inefficiencies associated with excessive production of ozone that must be neutralized through a catalytic converter. 
       SUMMARY 
       [0011]    In accordance with at least one exemplary embodiment of the invention, a system for the production of therapeutic ozone includes a disposable unit including medical oxygen, electrodes and a power supply and measurement system. 
         [0012]    A further exemplary embodiment may provide a sterile, disposable canister, vial or the like containing a unit dose of oxygen gas that can be interfaced with a reusable power source to convert that unit into ozone gas. This can act to maintain the gaseous mixture in a sterile environment to decrease the risk of contamination. 
         [0013]    In yet another exemplary embodiment, electrodes of the corona discharge mechanism may be incorporated within the disposable vial to decrease maintenance costs and increase performance of the ozone delivery system. Additionally, a unit dose of ozone may be provided to reduce the risk of environmental exposure and reduce the need for an ozone disposal element. Also, a unit dose of ozone that incorporates a mechanism that reduces ease of reuse of the disposable vial may reduce potentially harmful misuse of discharged canisters. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0014]    Further advantages of embodiments of the present invention will be apparent from the following detailed description of the preferred embodiments thereof, which description should be considered in conjunction with the accompanying drawings in which: 
           [0015]      FIG. 1   a  shows an exemplary top view of a sterile vial. 
           [0016]      FIG. 1   b  shows an exemplary cross-sectional view along line B of the sterile vial of  FIG. 1   a.    
           [0017]      FIG. 1   c  shows an exemplary perspective view of a sterile vial. 
           [0018]      FIG. 1   d  shows an exemplary enlarged cross-sectional view of the area circumscribed by line G of the sterile vial of  FIG. 1   b.    
           [0019]      FIG. 2   a  shows an exemplary perspective view of a sterile vial and attached actuator cap. 
           [0020]      FIG. 2   b  shows and exemplary diagrammatical view of an ozone conversion unit. 
           [0021]      FIG. 3   a  shows an exemplary perspective view of an actuator cap. 
           [0022]      FIG. 3   b  shows an exemplary inverted perspective view of the actuator cap of  FIG. 3   a.    
           [0023]      FIG. 3   c  shows an exemplary top view of the actuator cap of  FIG. 3   a.    
           [0024]      FIG. 3   d  shows an exemplary cross-sectional view along line D of the sterile vial of  FIG. 3   c.    
           [0025]      FIG. 3   e  shows an exemplary cross-sectional view along line C of the sterile vial of  FIG. 3   c.    
           [0026]      FIG. 4   a  shows an exemplary top view of a sterile vial. 
           [0027]      FIG. 4   b  shows and exemplary cross-sectional view along line E of the sterile vial of  FIG. 4   a  having a valve in the closed position. 
           [0028]      FIG. 4   c  shows an exemplary cross-sectional view along line E of the sterile vial of  FIG. 4   a  having a valve in the open position. 
           [0029]      FIG. 5   a  shows an exemplary perspective view of a sterile vial and an actuator cap. 
           [0030]      FIG. 5   b  shows an exemplary perspective view of sterile vial with an attached actuator cap. 
           [0031]      FIG. 5   c  shows an exemplary perspective and inverted view of the sterile vial and attached actuator cap of  FIG. 5   b.    
           [0032]      FIG. 5   d  shows an exemplary side view of the sterile vial of  FIG. 5   b.    
           [0033]      FIG. 6   a  shows an exemplary perspective view of a sterile vial and an actuator cap. 
           [0034]      FIG. 6   b  shows an exemplary perspective view of a sterile vial with an attached actuator cap. 
           [0035]      FIG. 6   c  shows an exemplary perspective and inverted view of the sterile vial and attached actuator cap of  FIG. 6   b.    
           [0036]      FIG. 6   d  shows an exemplary side view of the sterile vial and actuator cap of  FIG. 6   a.    
           [0037]      FIG. 7   a  shows an exemplary detailed perspective view of the sterile vial of  FIG. 1   a.    
           [0038]      FIG. 7   b  shows an exemplary detailed perspective and inverted view of the sterile vial  FIG. 1   a.    
           [0039]      FIG. 8  shows an exemplary detailed perspective view of the actuator cap of  FIG. 3   a.    
       
    
    
     DETAILED DESCRIPTION 
       [0040]    Aspects of the invention are disclosed in the following description and related drawings directed to specific embodiments of the invention. Alternate embodiments may be devised without departing from the spirit or the scope of the invention. Additionally, well-known elements of exemplary embodiments of the invention will not be described in detail or will be omitted so as not to obscure the relevant details of the invention. Further, to facilitate an understanding of the description, discussion of several terms used herein follows. 
         [0041]    The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments. Likewise, the term “embodiments of the invention” does not require that all embodiments of the invention include the discussed feature, advantage or mode of operation. 
         [0042]    Referring generally to  FIGS. 1   a - 6   d , a system for generating and delivering a sterile and substantially pure dose of ozone and oxygen is shown. An exemplary system may include a sterile vial  100 , an ozone conversion unit  200 , and an attachable actuator cap  300 . The sterile vial may be sealed, containing therein a corona discharge assembly  104  and oxygen. Ozone conversion unit  200  may include an ozone UV measurement assembly  216 , a data input mechanism such as a dial  214  to allow the user to select a desired ozone concentration, and a data display  218  to display input and output data such as desired concentrations and measurements. After sterile vial  100  is engaged to the ozone conversion unit  200 , an ozone concentration may be selected and power applied to effect corona discharge and the resultant conversion of oxygen to the selected concentration of ozone. Sterile vial  100  may then be disengaged and actuator cap  300  joined thereto, thus allowing for oxygen and ozone mixture withdrawal. This may be accomplished by attaching to actuator cap  300  a membrane that may be semi-permeable, or in the alternative, a step-wise withdrawal mechanism comprising two Leuer lock fittings capable of actuating sterile vial  100  and accommodating transfer of a gaseous mixture to an attachable syringe. The ozone delivery system may be employed in any of a variety of situations including, for example, the therapeutic treatment of humans or animals by way of injection. 
         [0043]      FIGS. 1   a - 1   d  show an exemplary embodiment of sterile vial  100 . Sterile vial  100  may have a variety of components, such as a casing  102 , corona discharge assembly  104 , electrical contact points  106 , a port and one-way valve  108  and a key structure  111 . Sterile vial  100  may be substantially sealed and filled with oxygen under pressure. Construction of the sterile vial may be accomplished by evacuating a vial under a vacuum; an exemplary pressure for which may be about 25 inches of Hg. The vial may be filled with, for example, about 10-30 ml of medical grade oxygen and then sealed. An exemplary embodiment may include port and one-way valve  108  for sealing, which may be constructed to reduce efflux of gas from sterile vial  100  and allow influx of gas when actuated. As depicted in  FIG. 1   d , this may be accomplished by a spring-valve mechanism  107 . One exemplary embodiment which may be included within port and one-way valve  108  is a series of valves to first allow a vacuum to be drawn and then to allow influx of oxygen. An exemplary series of valves may include a single valve with a first setting and a second setting at the center to form a Y-shaped configuration. The first setting would connect sterile vial  100  to a vacuum. After a vacuum is established within sterile vial  100 , the valve may be adjusted to the second setting thereby providing a path for the oxygen to flow into sterile vial  100 . Sterile vial  100  and packaging, if any, may then be sterilized. Gamma sterilization may be preferred over autoclaving, which involves temperatures that may increase pressure and compromise the structural integrity of sterile vial  100 . 
         [0044]    Casing  102  may be constructed out of a material that allows for UV transmission, such as, but not limited to, acrylic, quartz or any other such material known to one having ordinary skill in the art to have substantially similar absorption coefficients. This can allow passage of a UV beam through the gas so that the concentration of ozone can be measured. 
         [0045]    As depicted in  FIG. 1   b , corona discharge assembly  104  may be arranged within casing  102  and may comprise an outer electrode  104   a  and an inner electrode  104   b . They may be arranged to create an electric field, the strength of which can be changed using appropriate dielectrics and voltage settings. In one exemplary embodiment of the present invention, this can be accomplished by encasing outer electrode  104   a  in a dielectric material and incorporating an inner cylinder  112  of dielectric materials encasing inner electrode  104   b . Such a configuration can have the advantage of shielding the electrodes from long-term oxygen exposure. In another exemplary embodiment, the outer electrode may be situated outside sterile vial  100 , and may further be situated in ozone conversion unit  200 . This embodiment may create unusable ozone outside of sterile vial  100  that could result in atmospheric contamination. In another exemplary embodiment, corona discharge assembly  104  may be arranged to accommodate axial passage of UV light; or an alternative embodiment, transverse passage of UV light. Corona discharge assembly  104  may be connected to electrical contact points  106 . Electrical contact points  106  may be arranged to interface with the exterior of sterile vial  100 . 
         [0046]      FIGS. 2   a - 2   b  shows an exemplary diagram of ozone conversion unit  200  and sterile vial  100 . Ozone conversion unit  200  may be used to convert an amount of oxygen contained in sterile vial  100  to ozone by facilitating power. Ozone conversion unit  200  may include a high voltage transformer  210 . In an exemplary embodiment, high voltage transformer  210  may have a potential difference of about 5-25 kV. High voltage transformer  210  may be connected to a power source and electrical contact points  212 . In another exemplary embodiment, electrical contact points  212  may be arranged to reversibly interface with electrical contacts  106  of sterile vial  100 . 
         [0047]    Ozone conversion unit  200  may further include a dial  214 , a UV measurement assembly  216 , and a data display  218 . UV measurement assembly  216  may include components relating to measurement using UV absorption techniques, whereby a beam is passed through the ozone and oxygen mixture to be received by a detector. Such a beam may have a wavelength of within a range on the UV spectrum known to those skilled in the art to be absorbed by ozone such as ranges UV-A, UV-B, and UV-C; it may be preferable to use light emissions having wavelengths of about 253.7 nm, within the bounds of the UV-C range. In an exemplary embodiment, a mercury vapor lamp may be used to measure the concentration of ozone. An alternative exemplary embodiment may employ a UV light emitting diode or other instruments known to one having ordinary skill in UV absorption techniques. An exemplary detector may be a photodiode or other photo detecting instruments known to those having ordinary skill in the art. Dial  214  may be used to regulate or input a desired ozone concentration. An exemplary therapeutically effective concentration of ozone is 6% by volume. Sterile vial  100  may be constructed to be received by ozone conversion unit  200  in such a way that orients sterile vial  100  for successful UV measurement; this may be achieved by including a lock  217  on ozone conversion unit  200  capable of receiving key structure  111 . 
         [0048]    In an exemplary embodiment, electrical contact points  212  may be situated to interface with the interior of a receptacle  220  formed in the ozone conversion unit that is capable of receiving sterile vial  100 . UV measurement assembly  216  may be arranged to orient a UV measurement beam axially through and along receptacle  220  to be received by a UV detector  221 . In an alternative embodiment, UV measurement assembly  216  may be arranged to orient the UV measurement beam through receptacle  220  transversely. A further exemplary embodiment may include a door  222  to be closed upon an engaged sterile vial  100 , thereby reducing ambient light from infiltrating receptacle  220  and interfering with UV detector  221 . 
         [0049]    Data display  218  may be used to display measurement data collected by UV measurement assembly  216 , indicate power status, or convey other relevant information such as input data or to confirm engagement of sterile vial  100  and ozone conversion unit  200 . Data display  218  may be used to display any information or data that may be useful to one having ordinary skill in the art. Ozone conversion unit  200  may be constructed to receive power, which can be made to pass through high voltage transformer  210 , electrical contact points  212  and electrical contact points  106 , thereby causing corona discharge assembly  104  to act upon the oxygen contained by sterile vial  100  and effect the selected concentration of ozone. 
         [0050]      FIGS. 3   a - 3   e  depict an exemplary embodiment of an actuator cap  300 . Actuator cap  300  may be constructed to act upon port and one-way valve  108  thereby permitting influx of oxygen. In a further embodiment, actuator cap  300  may be constructed to act upon port and one-way valve  108  to permit efflux of ozone following ozone conversion. Actuator cap  300  may be constructed to irremovably attach to port and one-way valve  108 . Another embodiment of actuator cap  300  may include mechanisms known to one having ordinary skill in the art to prevent reattachment to port and one-way valve  108 . In yet another exemplary embodiment, actuator cap  300  may be formed to permit attachment of an oxygen source. In an alternate exemplary embodiment, actuator cap  300  may be formed to permit withdrawl of ozone to allow subsequent injection into a patient. One exemplary embodiment may include mechanisms to signal attachment of actuator cap  300  to port and one-way valve  108  sufficient for gaseous mixture influx or efflux. 
         [0051]      FIGS. 4   a - 4   c  shows an exemplary embodiment of actuator cap  300  engaged with sterile vial  100 .  FIG. 4   b  shows actuator  300  attached to sterile vial  100  wherein actuator cap  300  is not acting upon port and one-way valve mechanism  108 .  FIG. 4   c  shows actuator cap  300  attached to sterile vial  100  wherein actuator cap  300  is acting upon sterile port and one-way valve mechanism  108 . 
         [0052]      FIGS. 5   a - 5   d  shows another exemplary embodiment of sterile vial  100  and actuator cap  300 . Casing  102  may be formed of quartz or similar material known to one skilled in the art. Actuator cap  300  may be formed to engage with port and one-way valve  108 , as shown in  FIGS. 5   a - 5   b.    
         [0053]      FIGS. 6   a - 6   b  show yet another exemplary embodiment of sterile vial  100  and actuator cap  300 . Casing  102  may be formed to include an opaque sleeve  103  having a portion constructed of acrylic or similar material known to one skilled in the art whereby the interior of sterile vial  100  may be viewed. 
         [0054]      FIGS. 7   a - 7   b  show another exemplary embodiment of actuator cap  300 . Actuator cap  300  may be arranged to include a needle cap  700  and a valve actuator  702 . In one exemplary embodiment, needle cap  70  could include a clutch mechanism to reduce ease of removing actuator cap  300  from sterile vial  100  when actuator cap  300  is attached to sterile vial  100 . 
         [0055]      FIG. 8  shows yet another exemplary embodiment of sterile vial  100 . Inner electrode  104   b  may be positioned through an electrode cap  802 . The electrode cap may meet casing  102  at one end. Casing  102  may concentrically enclose a portion of an electrode seal  808  and an opposite end of casing  102  may meet a portion of electrode seal  808 . Outer electrode  104   a  may be positioned concentrically within electrode seal  808 . In one exemplary embodiment, port and one-way valve  108  may include a valve stem  805  may be positioned within outer electrode  104   a . Valve stem  805  may be attached to one end of a valve cap  800 . A spring  804  or similar compressible element known to one of ordinary skill in the art may be inserted in an opposite end of valve cap  800  and may be secured by a spring nut  806 . In one exemplary embodiment, port and one-way valve  108  may be constructed to require a pressure of about 400 psi to bias valve stem  805  to the open position. 
         [0056]    The foregoing description and accompanying drawings illustrate the principles, preferred embodiments and modes of operation of the invention. However, the invention should not be construed as being limited to the particular embodiments discussed above. Additional variations of the embodiments discussed above will be appreciated by those skilled in the art. 
         [0057]    Therefore, the above-described embodiments should be regarded as illustrative rather than restrictive. Accordingly, it should be appreciated that variations to those embodiments can be made by those skilled in the art without departing from the scope of the invention as defined by the following claims.