Patent Publication Number: US-9901431-B2

Title: Periodontal device for changing a pressure in an enclosed environment about a tooth for treatment of oral biofilms associated with periodontal disease

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. Ser. No. 13/027,925 filed Feb. 15, 2011 (Now U.S. Pat. No. 8,591,229 as issued Nov. 26, 2013), that claimed the benefit of U.S. provisional application No. 61/423,852 filed Dec. 16, 2010, both of which are incorporated herein in its entirety by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     The present disclosure relates to treatment of oral diseases and, more specifically, to devices and methods for treating oral biofilm composed of microbial components including bacterial, fungal, and viral components that can result in periodontal disease. 
     The statements in this section merely provide background information related to the present disclosure and may not constitute prior art. 
     Presently, dental trays are used to deliver selected medications for treating multiple oral conditions including periodontal conditions of the teeth and gums. These trays provide for the application of medicaments in close proximity to the teeth and gums such that the medicaments placed in the chamber of the tray are in contact with the selected tissues and/or infected gums. The trays must be placed on the teeth and gums for a sufficient period of time to maintain the medicaments in their proximity to the oral biofilm within the gums and tissues so that the medications can penetrate the biofilm with an expectation that the proximate positioning of the medicament will make direct contact therewith to begin the modification of the micro-environment. This often requires a number of repeated applications in order to adequately penetrate the biofilm as the proximate position of the medication with the biofilm may not always make the direct contact that is required. Repeated applications of the current proximate positioning trays must be applied to penetrate the biofilm and thereby control the microbial pathogens that cause the inflammatory conditions resulting in an infection in the host. 
     In some situations, current medicament delivery trays may not ensure that the medicament is delivered directly to the biofilm, but in some patient situations only place the medicament in close proximity to where the biofilm should be located. Current methods may not be able to therefore adequately modify the localized environment, such as altering the environment from one conducive to disease to one conducive to health and healing and/or the ability to manage and maintain such an environment one established. As such, there is a need for a device and method for improving the likelihood in some patient situations that the medicaments are applied directly to the biofilm to be treated, and that such direct application provides if for an ensured period of time for each use of the device and application of the treatment method. 
     BRIEF SUMMARY OF THE INVENTION 
     The inventor hereof has succeeded at designing apparatus and methods for the treatment of biofilm that can be associated with periodontal disease and other infections through the delivery of medicament directly to and about the biofilm under a controlled positive pressure so that the medicaments are delivered and maintained at the biofilm being treated during course of the treatment. As designed by the inventor, the present devices and methods provides application of the medicament under a positive pressure that enhances the control over the medication penetration of the biofilm during treatment. Through use hereof, the chemical and mechanical alterations of the biofilm can be controlled to modifying the biofilm environment from a situation that was favorable to pathogenic conditions to a condition that favors the host health and healing. The modified environment is maintained by regular use of the apparatus and method so the micro-environment of the tissues is conducive to health and healing and makes it difficult for the microorganisms to reestablish a pathogenic environment. 
     According to one aspect, an apparatus for the treatment of an oral biofilm associated with periodontal disease includes a body, a raised seal and a port. The body formed or configured to be fitted about all of the upper or lower teeth of a patient for enclosing the teeth. The body having a top portion and an outer wall and an inner wall with each composed of resilient elastomeric material molded for substantially conforming to the enclosed teeth and gum tissue proximate to the teeth. The body defining one or more internal recesses defined between the inner wall and the outer wall and defining a treatment chamber therein for receiving the enclosed teeth with the outer and inner skirts extending from the top portion and enclosing the teeth and at least a portion of the gum tissue proximate to the enclosed teeth. The raised seal formed distal from the top portion and about an inner surface of the outer skirt and an inner surface of the inner skirt and surrounding the one or more recesses and corresponding to a location along a gum line of the gum tissue of the enclosed teeth. The raised seal extending about the gum tissue and spaced apart from the teeth when placed thereon, and forming a substantially air tight seal against the gum line and separating the walls of the body from the enclosed teeth and gums and defining the treatment chamber between the walls of the body and the enclosed teeth and gums. The port positioned on at least one of the inner skirt and the outer skirt to receive a positive pressure from an external pressure source and to deliver the received positive pressure to within the cavity containing the teeth. The inner and outer skirts and the port configured to increase a biasing force of the raised seal against the gum line when positive pressure is received through the port and after placement of the apparatus onto the gum tissue and about the teeth for sealing the treatment chamber thereabout. 
     According to another aspect, an apparatus for the treatment of an oral biofilm associated with periodontal disease including a body configured to be fitted about all of the upper or lower teeth of a patient for enclosing the teeth with the body having a top portion and an outer wall and an inner wall and each being composed of resilient elastomeric material molded for substantially conforming to the enclosed teeth and gum tissue proximate to the teeth. The body defining one or more internal recesses defined between the inner wall and the outer wall and defining a treatment chamber therein for receiving the enclosed teeth. The outer and inner skirts extend from the top portion and enclosing the teeth and at least a portion of the gum tissue proximate to the enclosed teeth. The raised seal formed distal from the top portion and about an inner surface of the outer skirt and an inner surface of the inner skirt and surrounding the one or more recesses and corresponding to a location along a gum line of the gum tissue of the enclosed teeth. The raised seal extends about the gum tissue and spaced apart from the teeth when placed thereon and forms a substantially air tight seal against the gum line and separating the walls of the body from the enclosed teeth and gums and defining the treatment chamber between the walls of the body and the enclosed teeth and gums. A port is positioned on at least one of the inner skirt and the outer skirt to receive a positive pressure from an external pressure source and to deliver the received positive pressure to within the cavity containing the teeth. The port having an integrated valve for selectively receiving and maintaining the positive pressure within the chamber. The inner and outer skirts and the port are configured to increase a biasing force of the raised seal against the gum line when positive pressure is received through the port and after placement of the apparatus onto the gum tissue and about the teeth for sealing the treatment chamber thereabout. 
     According to yet another aspect, an apparatus for the treatment of an oral biofilm associated with periodontal disease including, the tray as described above in the prior two paragraphs, further including the body having one or more conducting channels fluidly coupling the two or more treatment chambers with the port for equalizing the pressure received by the port to the separate treatment chambers. 
     In yet another aspect, a method of manufacturing an oral tray for use in treating an oral biofilm associated with a periodontal disease in a patient, the method including obtaining an impression of a plurality of teeth of a patient and at least a portion of a gum tissue associated with the teeth and the teeth being associated with at least one of an upper set of patient teeth and a lower set of patient teeth and having the periodontal disease to be treated. The method includes selecting a base material from among a plurality of available resilient elastomeric materials for forming the tray body and selecting a skirt material from among the plurality of available resilient elastomeric materials for forming an outer skirt from an outer wall of the tray body and an inner skirt from the inner wall of the tray body. The method also includes forming the oral tray from the selected base material with the outer skirt and the inner skirt including the skirt material, the oral tray formed to include a plurality of internal recesses for one or more treatment chambers each for containing one or more of the teeth when the tray is positioned thereon. This forming including forming a raised seal about an inner surface of the outer skirt and an inner surface of the inner skirt and surrounding the recesses and corresponding to a location along a gum line of the gum tissue of the patient associated with the enclosed teeth. The raised seal being formed to extend about the gum and spaced apart from the teeth, and configured to form a substantially air tight seal against the gum line. The method also including installing a port fluidly coupled to at least one of the treatment chambers, the port being installed on at least one of the inner skirt and the outer skirt and configured to receive a positive pressure from an external pressure source and to deliver the received positive pressure to within the coupled treatment chamber. This method wherein selecting of the skirt material and the forming of the oral tray are each configured to increase a biasing force of the raised seal against the gum line when positive pressure is received through the port and after placement of the apparatus onto the gum tissue and about the teeth for sealing the coupled treatment chamber thereabout. 
     Further aspects of the present disclosure will be in part apparent and in part pointed out below. It should be understood that various aspects of the disclosure may be implemented individually or in combination with one another. It should also be understood that the detailed description and drawings, while indicating certain exemplary embodiments, are intended for purposes of illustration only and should not be construed as limiting the scope of the disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a cross-sectional view of a healthy tooth. 
         FIG. 2  is a cross-sectional view of a tooth with periodontal disease showing keratinized gingiva partially separated from the tooth. 
         FIGS. 3 and 4  are cross-sectional views of a tooth showing the progression of periodontal disease and the deterioration of the aveolar crest. 
         FIGS. 5A-5C  are views of one exemplary embodiment of a positive pressure tray with  FIG. 5A  being a cross-sectional view of the positive pressure tray placed about a tooth and associated gum tissue,  FIG. 5B  being a top perspective view of the tray of  FIG. 5A , and  FIG. 5C  being a bottom view of the tray of  FIGS. 5A and 5B . 
         FIGS. 6A-6C  are views of a second exemplary embodiment of a positive pressure tray with  FIG. 6A  being a cross-sectional view of the positive pressure tray placed about a tooth and associated gum tissue,  FIG. 6B  being a top perspective view of the tray of  FIG. 6A , and  FIG. 6C  being a bottom view of the tray of  FIGS. 6A and 6B . 
         FIGS. 7A-7C  are cross-sectional views of a third exemplary embodiment with the positive pressure tray placed about a tooth and associated gum tissue containing the biofilm wherein the top layer of the outer member is placed below the top of the tray and the bottom member is below the seal region ( FIG. 7A ), the bottom member is at the seal region ( FIG. 7B ), and the bottom member is above the seal region ( FIG. 7C ). 
         FIGS. 8A-8C  are views of a fourth exemplary embodiment of a positive pressure tray with  FIG. 8A  being a cross-sectional view of the positive pressure tray placed about a tooth and associated gum tissue,  FIG. 8B  being a top perspective view of the tray of  FIG. 8A , and  FIG. 8C  being a bottom view of the tray of  FIGS. 8A and 8B . 
         FIGS. 9A-9C  are views of a fifth exemplary embodiment of a positive pressure tray with  FIG. 9A  being a cross-sectional view of the positive pressure tray placed about a tooth and associated gum tissue,  FIG. 9B  being a top perspective view of the tray of  FIG. 9A , and  FIG. 9C  being a bottom view of the tray of  FIGS. 9A and 9B . 
         FIGS. 10A-10C  are views of a sixth exemplary embodiment of a positive pressure tray with  FIG. 10A  being a cross-sectional view of the positive pressure tray placed about a tooth and associated gum tissue,  FIG. 10B  being a top perspective view of the tray of  FIG. 10A , and  FIG. 10C  being a bottom view of the tray of  FIGS. 10A and 10B . 
     
    
    
     It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features. 
     DETAILED DESCRIPTION 
     The following description is merely exemplary in nature and is not intended to limit the present disclosure or the disclosure&#39;s applications or uses. 
     Before turning to the figures and the various exemplary embodiments illustrated therein, a detailed overview of various embodiments and aspects is provided for purposes of breadth of scope, context, clarity, and completeness. As an initial note, any reference herein that refers to an orientation such as upper, lower, inner and outer, is by way of exemplary reference to the drawings. It should be understood to those skilled in the art that the oral tray as described herein can be oriented in a different direction and that such orientation references would then shift, but still be within the scope of the present disclosure. 
       FIG. 1  shows a healthy tooth, as generally indicated at  10 . It is seen that a healthy tooth has gum tissue  11  with a junctional epithelium  12  covering the enamel  14  of the tooth  10 , and attaching to the surface of the tooth  10  so that the cementum  16  of the tooth  10  is not exposed. The periodontal ligament  13  is composed of connective tissue fibers that anchor the tooth  10  with one end of each fiber being attached to the cementum  16  covering the root of the tooth  10  and the other end being embedded in the bony tooth socket defined by the aveolar bone  18 . The aveolar bone  18  has an aveolar crest  20  extending nearly to the cementoenamel junction  22  to form the bony tooth socket for the tooth  10 . The upper region of gum tissue includes the regions having the junctional epithelium  12  and the cementoenamel junction  22  (CEJ) are referred to as gingiva  15  that includes the marginal gingiva  15 A, and the low region of gum tissue below the cementoenamel junction  22  is referred to as the attached gingiva  15 B referring as the portion where, in a healthy tooth, the gum tissue  11  is attached to the cementum  16 . 
     By comparison, a diseased tooth  10 ′ with enamel  14 ′ and cement enamel junction (CEJ)  15 (C), as shown in  FIGS. 2, 3 and 4 , has inflammation from one or more biofilm (not shown) that has caused periodontal disease. In the diseased tooth  10 ′ the junctional epithelium  12  is moved apically (or toward the apex of the root) thereby exposing the cementum  16  and enlarging a sulcus  24  between the gum tissue  11  and the tooth  10 ′ creating a pocket  26  therebetween. As the inflammation spreads, the aveolar bone  18  is destroyed, such a shown as a reduction in height in  FIG. 2 . This reduction in aveolar bone  18  and the creation of pocket  16  increases tooth mobility and can lead to a loss of the tooth  10 ′. The spread of the inflammation through vascular channels of the aveolar bone  18  is shown by the arrows A and B in  FIGS. 3 and 4 .  FIG. 3  illustrates an end view of two adjacent teeth  10 ′A and  10 ′B having enamel  14 ′A and  14 ′B, respectively, with the effects on the surrounding gum tissue  11 , periodontal ligaments  13 , and aveolar bone  18  due to the periodontal disease. 
     Oral biofilm communities begin to grow in the enlarged sulcus  24  of the periodontal tissues. First oral biofilm inhabitants are aerobic bacteria, but as the pocket  26  begins to develop, facultative bacteria biofilm begin to develop causing changes in the environment from an aerobic community to an oxygen depleted environment. This continues until the oxygen levels are obliterated resulting in the growth of obligate anaerobes that become the predominant biofilm species. The biofilm components, their products and the host products in response to the pathogenic community result in specific changes and alterations to the environment of the tooth and gums. These changes can include a breakdown of the host tissues, an inflammation of the gums, and a loss of tissue integrity, each of which further result in additional disease and infection. 
     In accordance with various embodiments of the present disclosure, an oxygenation or oxidation reduction medicament, antimicrobial or antibiotic or other medicament can be brought into repeated and direct contact with the biofilm community such that the medicament can penetrate the biofilm and alter the biofilm by chemical and/or mechanical means such that the biofilm community is affected. Furthermore, through continued use, any changes in the biofilm community can be maintained by repeated application of the medication to the micro-environment. 
     The destruction of the bony structure is caused by osteoclastic activity acid/base changes and other reasons. Although there is continuous osteoblastic activity, resulting in bone regeneration, but for various reasons the bone regeneration activity cannot keep up with the osteoclastic, bone destroying activity. In accordance with the present invention, when an antimicrobial medicament, such as a solution of tetracycline, is brought into repeated and direct contact with the diseased bone structure, usually below the gum line, it has surprisingly been found that the osteoblastic activity exceeds the osteoclastic activity resulting in net bone regeneration. In accordance with this invention, it has been determined that the tetracycline (or other medicament) solution slows osteoclastic activity but does not adversely affect osteoblastic activity. The bone regeneration decreases infection and body response to an infection and results in a marked decrease in the need for, and the invasiveness of, periodontal surgery. 
     In one embodiment, an apparatus such as a tray can be configured according to the present disclosure for the treatment of periodontal disease. Such an apparatus includes a body configured to be fitted about all of the upper or lower teeth of a patient for enclosing the teeth. The body can be monolayer made from an elastomeric material shaped to conform to the teeth and gums tissue proximate to the teeth of the patient. 
     In other embodiments, the body can be made to have a bilaminar structure with an outer wall and an inner wall composed of resilient elastomeric material molded for substantially conforming to enclosed teeth and gum tissue proximate to the teeth. The bilaminar body can have one or more internal recesses defined between the inner wall and the outer wall configured for receiving the enclosed teeth. 
     The body can be monolayer or bilaminar having a top outer surface positioned opposite to the one or more internal recesses and between an external surface of the outer wall and an external surface of the inner wall. A raised seal can be formed by the monolayer material or from bilaminar material such that it is formed about an inner surface of the outer wall and an inner surface of the inner wall and surrounding the recesses and corresponds to a location along a gum line of the patient associated with the enclosed teeth. The raised seal is configured to extend about the gum and spaced apart from the teeth, and to form a substantially air tight seal against the gum line. 
     A monolayer skirt is positioned external to the seal and a bilaminar skirt is positioned external to the outer wall and to the inner wall of the body having the raised seal formed thereon. The monolayer skirt or bilaminar skirt each have an outer portion configured to reinforce the outer wall and an inner portion configured to reinforce the inner wall, each reinforcement being proximate to the raised seal and each being configured to restrict an outward movement of the walls of the body during and after placement of the apparatus onto a portion of the gum tissue forming the gumline for increasing the substantial air tight seal against the gum tissue. The skirt can be formed as an extension of the body or the walls of the body, on an external surface. In some embodiments, the skirt can include an outer layer on the wall or incorporated into the wall for providing increased reinforcement to the wall and/or providing a resistive force to the wall to prevent or restrict the movement of the wall outward and thereby increasing the sealing force of the seal against the gumline when the tray assembly is fitted on a patient. This skirt/extension can be fortified in a monolayer thickness, or it can be bilaminar so a recess exists between the outer and inner surfaces of the seal.  FIGS. 5A-C  to  9 A-C are various embodiments of the skirt in exemplary relationship to the walls and the seals during the use of the tray and include exemplary structures and various features of such a tray assembly and its intended method of use for treatment of an oral biofilm. 
     By way of example,  FIGS. 5A-C  illustrate a tray  100  having a body  102  with walls  104  also forming a skirt  106  and an air tight seal  108  positioned on an inner surface of the walls  104  having one or more recesses  105  for receiving one or more teeth  10  therein, the recesses  105  and seal  108  forming a treatment chamber  110  or just chamber  110 . The seal  108  is provided a biased contact in the direction of force arrow F with the surface of the gum tissue  11  or gingiva  15  by the skirt  106 . The line of contact for the seal  108  with the gum tissue  11  around a set of teeth  10  is referred herein as gum line  111 . Also shown for clarity in  FIG. 5A  is the nerve  17  of the tooth  10 . In this embodiment, the skirt  106  portion of the walls  104  of the body  102  are composed of a reinforcing material for elastically resisting the outward movement of the walls  104  away from the tooth  10  and/or providing a bias force F of the seals  108  against the gum tissue  11  along the gum line. 
     In this exemplary embodiment, the skirt  106  can be a portion of the walls  104  or attached to the walls  104  with the skirt  106  being considerably less elastic resilience that of the upper portion of the body  102  of the tray  100 . The walls  104  with the stiffened reinforcing skirt  106  in the area of the seal  108  working with the seal  108  biased against the gum line tissue  11 , creates a chamber  110  between the tooth  10  that is in one or more of the recesses  105  and gum tissue  11  that encloses the CEJ  22  that can be pressurized. As shown, tray  100  can be contoured formed to fit an individual patient&#39;s teeth and can include a conforming of the seal  108  about each teeth  10  and continuously about all teeth  10 . 
     After the tray  100  is placed about the tooth  10  (all teeth  10 ) the seal  108  provides an air tight enclosing of the chamber  110  about the teeth  10  and gum tissue  11  that includes the CEJ  22  and a pressure can be added to the chamber  110  through a pressure port  112 . The amount of pressure will depend on the continuity and accuracy of the sealing of the seal  108  against the tissue of the gum line  111  as well at the amount of bias provided by the skirt  106  and/or walls  104  to the seal  108 , as well as the integrity of the seal  108 . 
     While a single pressure port  112  is shown, it is possible that more than one pressure port  112  or another embodiment of a pressure port  112  is provided. Generally, while not shown, one skilled in the art will understand from this disclosure that the pressure port  112  can include and orifice  114 , a valve  116 , a pressure limiter  117  an attachment fixture  118  with an attachment seal (not shown). A port valve  116  provides a passage from outside a wall  104  to the chamber  110  through which a fluid pressure (such as an air pressure, or pressurized medicament) from an external source is received. The pressure port can include a mating attachment for mating with a standard outside pressure source and a port seal that contains the pressure during the transfer and that will help to ensure the proper controlled receipt of the desired amount of pressure to the chamber  110 . 
     In some embodiments, the body  102  of the tray  100  can include one or more conducting channels  122  the fluidly connect one or more regions of the chamber  110 . The conducting channels  122  can enable the equalization of pressure throughout the chamber  110  and about the seal  108 . The inclusion of conducting channels  122  can be included in a connecting portion  120  of body  102  as shown in  FIGS. 5B and 5C  with the conducting channels  122  traversing through the connecting portion  120  and fluidly connecting the two opposing inner side walls  104 . In other embodiments, other arrangements are also possible. For example, in another embodiment the conducing channels  122  can be positioned laterally within a side wall  104  parallel to the seal  108 , such as along the portion aligned with the gum line tissues  111  (also referred herein to as the gum line  111 ). Generally, the conducting channels  122  can include one or more orifices (not shown) that fluidly connect with the various portions of the chamber  110  for pressure equalization throughout the chamber  110 . 
     In some embodiments, the monolayer skirt can be attached by or about a periphery to the outside surface of the walls external to the seal so as to form a skirt chamber between the skirt and the exterior wall that is substantially airtight. In such embodiments the skirt chamber can be prefilled with a variable stiffness material such as the herein described acrylic, by way of example, or it can include a port in the skirt. For example, filling composition can be placed within the skirt chamber during fabrication of the tray or can be later applied via the port. The port is fluidly coupled to the skirt chamber for selectively providing a filling composition into the skirt chamber. For example, the more filling composition added to the skirt chamber or positive pressure provided therein can increase the biasing force applied by the skirt to the wall and therefore to the seal against the gum line. 
     By way of example,  FIGS. 6A-C  are an embodiment of a skirt  106  being constructed to have a monolayer outer body  130  positioned outside of body  102  that includes more recesses  105  for receiving one or more teeth  10  and that forms the chamber  110  and includes the seals  108 . In such embodiments, the skirt  106  that provides the biasing force F is a part of or formed by the monolayer outer body  130 . In this manner, the body  102  forming the chamber  110  and having the seals  108  can be made of a consistent material, such as one ideally suited for forming to the contours of each patient&#39;s teeth and gum line. In some embodiments, the monolayer outer body  130  is formed as an external separate surface structure that can be attached or just placed over the body  102  before or after the body  102  is placed on the teeth  10  and gum tissue  11  to be treated. This could be referred to as a two-piece embodiment. In other embodiments, the monolayer outer body  130  can be attached or otherwise formed or constructed as a unibody with or on the external surfaces of the outer wall  104  of the body  102 . In some embodiments, a skirt chamber  134  or ancillary chamber is formed between the outer body  130  and body  102  along one or more portions of the outer surface area of the body  102 . The skirt chamber  134  may be filled or be a void. 
     The monolayer outer body  130  can be formed of an elastic resilient material and dimensioned to the walls  104  of the main body so that the skirt  106  of the monolayer outer body  130  can apply a pressure F to the wall  104  proximate to the seal  108 . This can be preferably a consistent amount of pressure F along the length of the seal  108  and gum line  111 . 
     As shown the monolayer outer body  130  defines the skirt  106  having the inner skirt  106  outside of the inner wall  104  and the outer skirt  106  outside of the outer wall  104 . The monolayer outer body  130  also includes a top connecting portion  132  connecting the two opposing skirts  106 . The top connecting portion  132  can also add to the resilience and aid the skirts  106  in applying the biasing force F. As shown, the skirt  106  engages the outer surface of the outer and inner walls  104  defining the channel  110  therebetween to apply the biasing force F against each to restrict the outer movement of the walls  104  and/or to apply force F to each wall  104  and therefore to the outer and inner seals  108  along the gum line  111 . The applied biasing force F of the skirt  106  of the monolayer outer body  130  increases the air tightness of the seal  108  against the gum line  111 . 
     While not shown in  FIGS. 6A-C , one or more pressure ports  112  as discussed above can be utilized with this embodiment as well. Such pressure ports  112  can penetrate and create a fluid connection from outside of the monolayer outer body  130  to inside the body  102  in connection with the chamber  110 . 
     By way of another example,  FIGS. 7A-7C  are of another embodiment the positive pressure tray  100  can have the skirt  106  attached at one or more points on the outer surfaces of the walls  104  of the body  102  including the inside wall  104  and the outside wall  104 . This embodiment differs from the embodiment of  FIGS. 6A-6C  as the skirt  106  is formed by outer layer  140  of wall  104  and does not include a full separate body  130  and does not include the top connecting portion  132 . The outer layer  140  is composed of the resilient stiffened material for the skirt as described above. 
     The inner and outer skirts  106  of this embodiment are separate and not attached or connected and do not form a single unibody construction that covers the entire outer top surface of the body  102 . As such, the outer layer  140  has an upper end  142  and a lower end  144 , one or both of which can be attached to the body  102 . In this embodiment, a skirt chamber  146  is formed between the outer surface of wall  104  and the inner surface of the skirt  106  which is formed by the outer layer  140 . The skirt chamber  146  can be filled as described above or can be a void. The upper end  142  is attached to the wall  104  below a top of the body  102  of tray  100 , but the position of such attachment can vary from that illustrated and still be within the scope of the present disclosure. 
     The orientation and position of the lower end  144  of skirt  106  can be different in slightly different embodiments.  FIG. 7A  illustrates a tray  100  having the lower end  144  of the skirt  106  or outer layer  140  position below or beyond the position of the seal  108  and/or the gum line  111 . As shown, the lower end  144  can extend down the wall  104  to a point in close proximity to an end of the wall  104 . The lower end  144  can be attached to the wall  104  at this point or the lower end  144  along with the other portions of the outer layer  140  can be formed with the body  102 . In this embodiment, the lower end  144  of the skirt  106  exerts the biasing force F to the lower end of wall  104  and therefore biases or applies pressure to the seal  108  to the gum line  111 . 
     In the embodiment of  FIG. 7B , the tray  100  has the lower end  144  of skirt  106  is positioned proximate to or substantially with the seal  108 , on the outside of wall  104  opposing the inner wall to which the seal  108  is attached or formed. The lower end  144  can be free or can be attached to the outer surface of wall  104  proximate an outer surface with the seal  108 . In this embodiment, the lower end  144  of the skirt  106  exerts the biasing force  4  directly to the wall  104  on the other side of which is the seal  108  contacting the gum line  111 . As such, the lower end  144  is providing a direct force F through the wall  104  to bias or pressure the seal  108  engagement with the gum line  111 . 
     In the embodiment of  FIG. 7C  the lower end  144  of the skirt  106  is positioned above and/or away from a distal or free end of the wall  104  and above the position of the seal  108  in the direction of the upper end  142 . The skirt  106  still applies the biasing force F to the wall  104  through the outer layer&#39;s attachment at the upper end  142  and its positioning at the lower end  144 . The lower end  144  can be attached to the outer surface of wall  104  or can be free. In this embodiment, the resilience and stiffness of the skirt  106  from the upper end  142  through the outer layer  140  to the lower end  144  provides the biasing force F to the wall  104  and therefore to the seal  108  in the direction of the gum line  111 . 
       FIGS. 8A-C  illustrate another embodiment that is similar to that of  FIG. 7A-C , except in this embodiment, the skirt  106  has an outer layer  150  that is formed along or on the outer surface of the wall  104  of body  102  and does not create the skirt chamber. The outer layer  150  has a lower end  152  and an upper end  154  with the outer layer  150  being attached to the outer surface of the wall  104  from the upper end  154  to the lower end  152 . Of course this attachment can be by way of co-forming or manufacturing. The skirt  106  formed on the outer surface of the wall  104  essentially creates a bilaminar formation, with the wall  104  being formed of one material and the outer layer  150  forming the skirt  106  being that of the described skirt material. In this embodiment, the outer layer  150  or skirt  106  provide the stiffness and biasing to the wall  104  and to the seal  108  towards to the gum line  111 . 
     As noted above, in other embodiments, the skirt  106  can be a bilaminar structure defining a substantially airtight skirt chamber such as illustrated by ways of examples in the embodiments of  FIGS. 9A-C  and  10 A-C. 
     In the embodiment of  FIGS. 9A-C , the skirt  106  is formed from a bilaminar structure  160  having a first layer  162  position on the outer surface of wall  104  and an opposing second layer  164  position opposite thereof, and forming an enclosed skirt chamber  166  therebetween. The skirt chamber  166  of the bilaminar structure  160  of this skirt  106  increases the reinforcement of the outer and inner wall  104  and provides an increase in biasing force F against the outer and inner walls  104  when the skirt chamber  166  is either fused with a filling material or receives a pressure from an external source. The skirt chamber  166  can be prefilled during fabrication of the tray  100  or post filled with a filling composition during use of the tray  100  with a patient. The bilaminar structure  160  of the skirt  106  can be attached about the outer surface of the outer and inner walls  104  for providing reinforcement thereto and in particular proximate to the portion of the walls  104  on which the seal  108  is positioned on the inner surface. The bilaminar structure  160  can provide for increasing biasing or applying an increased pressure or bias force F by placement of a positive pressure within skirt chamber  166  by way of one or more skirt ports  168 . Additionally, an increased pressure result when the chamber  110  of the body  102  receives a treatment pressure. 
     The skirt port  168  is fluidly coupled to the skirt chamber  166  for receiving a filling composition or skirt pressure. This can include a filling composition such as a pressurized liquid, gas, or gel, such as an oxygenating source at a positive pressure, or can include a variable stiffness acrylic or other variable stiffness compound or composition. The skirt port  168  can include a valve  116  for selectively receiving the pressured liquid, gas, or gel and maintaining the received pressured filling composition for applying the biasing force F to the walls  104  and/or ensure that a desired pressure is maintained by the skirt chamber  166 . The skirt port  168  can also include a pressure limiter  169  to ensure that no excessive pressure is provided to the skirt chamber  166 . 
       FIGS. 10A-C  illustrates a slightly different bilaminar structure  160  that is lower on the wall  104  and proximate to the seal  108 . In this illustrated embodiment, only a single skirt port  168  is illustrated. However, this also re-illustrates the inclusion of the pressure port  112  for receiving pressure into the treatment chamber  110  as described above. As noted, all of the embodiments, whether illustrated in the figures or not, may include one or more pressure ports  112 . 
     As describe in these various exemplary embodiments, various materials could be incorporated into this body, the walls, the skirt and the seal to provide adequate pressure to maintain the contact with the gingiva to an airtight seal is maintained. Materials can be placed into the bilaminar recess by design during the fabrication of the tray, or a port can be fabricated into the design of the tray extension. The seal and the extension are configured to form a substantially air tight seal against all portions of the gum line. 
     In some embodiments at least a portion of one or more of these components can be partially or complete composed of an acrylic adapted for variable stiffness responsive to applied heat energy. A suitable acrylic is one that can be configured with the tray but also has a variable stiffness that can be adjusted by a caregiver to a desired stiffness during use by applying heat or electromagnetic energy, such as by hot or cold water or air, or by energy applied to filaments or other transducers placed within the acrylic or in close proximity thereto. For example, a variable stiffness acrylic can be used in the composition of the walls supporting the raised seal, in the skirt or as a filling compound within a skirt chamber. After the tray assembly is formed, the acrylic of the tray can be heated to allow for placement of the tray about the teeth and gums. The acrylic of the tray can then be cooled or allowed to cool wherein the acrylic stiffens and such stiffening increases biasing force of the seal about the gum tissue forming a portion of the gumline to increase the air tightness of such seal. This can also prevent the outward movement of the seal and/or wall of the tray during placement of a positive pressure within the treatment chamber also referred as the chamber. After the treatment is completed, the acrylic can once again be heated to allow for the removal of the biasing force and the removal of the tray from the teeth and gums. 
     Additionally, the body can include a port operatively coupled with one or more of the recesses forming the treatment chamber. The port has an external interface for coupling to a positive pressure source and/or a medicament source. This port provides for the selective placement of a positive pressure and/or medicament from an external source to within the treatment chamber. This can be a simple port for selectively allowing the placement of a medicament by way of the tip of a needle attached to a syringe, or can include an attachment mechanism or coupling means as may be suitable for attaching to a positive pressure and/or medicament source. The body port can be configured to receive a medication having a positive pressure and wherein the body, seal, skirt and port are configured for maintaining the received positive pressure about the enclosed teeth and gums. 
     The body port can include a valve for selectively receiving and maintaining a medication under positive pressure from a positive pressure medication source. For example, the body port can be configured for receiving a positively pressured oxygenating agent, such as hydrogen peroxide, from the positive pressure source. In such embodiments, the body, seal, skirt and port are configured for providing the received oxygenating agent within the recess and about the enclosed teeth and gum. This can also include, but is not limited to, coupling to an oxygenating, oxidative reduction, and/or ozone source or other gas, liquid or gel source or material. 
     In some embodiments, a pressure limiter can be provided in fluid connectivity to the medication chamber, or recesses or incorporated into the body for limiting an amount of positive pressure received into the recess from the positive pressure source. In this manner, the pressure limiter can be configured to prevent the receiving of a pressure that is harmful or that would tend to force the assembly/tray off of the substantially airtight seal with the gum tissue. 
     The body, seal, skirt and port are configured to cooperatively seal about the gum tissue forming a gumline and provide a medication chamber about the enclosed teeth and gums. 
     Additionally, in some embodiments, one or more conducting channels can be formed or provided in the body to fluidly connect two or more recesses together. In this manner, the conducting channels can equalize the pressure within the treatment chamber throughout the treatment chamber. 
     Additionally, in some embodiments, one or more electromagnet or energy conducting material such as an electrical or magnetic conducting material, by way of example, can be utilized in forming the body of the monolayer material or between the chambers of the bilaminar body. In this manner, the conducting material can provide a means of providing electrical, magnetic or other forms of energy within and throughout the treatment chamber. A means of external attachment to this conducting material can be provided via a port or other sealed attachment through the tray material. 
     According to one embodiment, a method for treating periodontal disease including fitting a tray about all of the upper or lower teeth of a patient. The tray has a body composed of resilient elastomeric material molded for substantially conforming to enclosed teeth and gum tissue proximate to the teeth. The body defines at least one recess to conform to the teeth. A raised seal surrounds the recess corresponding to a location along a gum line of the patient. The seal is configured to extend about the gum and spaced apart from the teeth. An extension is formed to support the seal and extend beyond the seal to engage the outer surface of the gum tissue. The extension of the tray material that extends over the gum tissue can be modified in thickness to provide adequate support to maintain an airtight seal around the teeth. This extension can be fortified in a monolayer thickness, or it can be bilaminar so a recess exists between the outer and inner surfaces of the seal. Various materials can be incorporated into this seal to provide adequate pressure to maintain the contact with the gingiva to as an airtight seal. Materials can be placed into the bilaminar recess by design during the fabrication of the tray, or a port can be fabricated into the design of the tray extension. The seal and the extension are configured to form a substantially air tight seal against all portions of the gum line. A port can be operatively coupled with the recess and has an external interface for coupling to a source of positive pressure so pressure of the extension can be altered to provide an airtight seal of the tray around the teeth. The body, seal and skirt/extension are configured to cooperatively seal about the teeth and gum tissue and to provide a positive pressure within the recess and about the teeth and gum tissue responsive and the extension contact and pressure generated against the tissue can be modified by receiving a positive pressure from the coupled positive pressure source or by receiving liquid, gel or other materials between the bilaminar portions of the seal extension. The method also includes applying a positive pressure within the tray to overcome crevicular flow so that an oxygenating agent, such as hydrogen peroxide, ozone or other oxidative/reductive materials can be applied to the gingival recess or periodontal pocket in the applied positive pressure within the recess and about the enclosed teeth and gums. 
     According to another embodiment, an apparatus for the treatment of periodontal disease including a body fitted to be about all of the upper or lower teeth of a patient. The body is composed of resilient elastomeric material molded for substantially conforming to enclosed teeth and gum tissue proximate to the teeth. In some embodiments, the body is composed of a material including impregnated fibers. Certain of these fibers may be used to conduct adequate electrical currents, or magnetic fields, or other forms of energy, that can activate or modify the medications placed within the tray and/or the micro-environment of the tissues enclosed or covered by the tray. Certain of these fibers can also be used to conduct light, magnet fields or other energy sources throughout the tray to activate, modify or in some manner alter the materials placed within the tray or the micro-environment of the material or tissues that are in close proximity or enclosed by the tray. 
     At least one recess is formed in the body to conform to the teeth. A raised seal surrounds the recess corresponding to a location along a gum line of the patient. The seal is configured to extend about the gum and spaced apart from the teeth and configured to form a substantially air tight seal against all portions of the gum line. An extension of the tray is formed to overlay the gum and oral tissues to complete the formation of the airtight seal, to support the seal and to serve to maintain an airtight environment. The seal can be monolayer, or bilaminar with a recess between the materials of the seal. A port is operatively coupled with the recess of the seal. The port has an external interface for coupling to a source of positive pressure or it can be configured to be a portal through which a syringe or other device can be introduced into the region between the outer and inner aspects of the seal so a liquid, gas, or gel could be introduced into this region. The body, seal and port are configured to cooperatively seal about the teeth and gum tissue and to provide a positive pressure within the recess and about the teeth and gum tissue responsive to provide a positive pressure from the coupled positive pressure source so an airtight association exists around the teeth and gums. 
     A body port can be configured through the tray material to reach the region around the teeth to receive a positively pressured oxygenating agent such as air, oxygen or other gas, hydrogen peroxide, ozone, oxidative reductive material or other agent from the positive pressure source. The body, seal and body port are then configured for providing a positively pressured oxygenating agent such as air, oxygen or other gas, hydrogen peroxide, ozone, oxidative reductive material or other agent within the recess and about the enclosed teeth and gum. The pressure can be modified in a manner that the external force can exceed the internal gingival crevice or periodontal pocket force so that materials can be delivered to the gingival crevice or periodontal pocket. As such, the external interface of the port can be configured for coupling to an oxygenating, ozone, oxidative/reductive source. 
     In some embodiments, the body includes one or more conducting channels connecting two or more sections of the recess for transmitting the received positive pressure and equalizing the positive pressure between the two or more sections of the recess. 
     In some embodiment a pressure valve can be coupled to the external interface of the port, the pressure valve configured for controlling the positive pressure received into the recess from the positive pressure source. In other embodiments, a pressure limiter is coupled to the external interface of the port for limiting the amount of positive pressure received into the recess. 
     In some embodiments, a skirt extends from the body and enclosing at least a portion of the seal. The skirt can be composed of a material having greater rigidity than the seal and configured for limiting the outward movement of the seal from the gum line. The skirt/extension can be monolayer or bilaminar in configuration. Materials can be placed between the bilaminar layers (gas, liquid, gel, other) to provide adequate pressure against the tooth surface and gum tissue to provide an airtight or adequate seal. The skirt can also have a port so that materials (liquid, gas, gel) could be selectively modified to increase or decrease the pressure of the tray skirt against the gum tissue, or the skirt can be modified in thickness and length of a monolayer material for pressure control. 
     As described herein, the present methods and systems can provide for the delivery of positive pressure based medications to a wound. In one embodiment, the positive pressure systems and methods provide for the positive pressure delivery of oxygen directly to the infected tissue positive pressure environment (hyperbaric oxygen) for the treatment of periodontal disease. Oxygen is bactericidal for anaerobic bacteria and possesses bacteriostatic effects and affects the growth and reproduction of some fungi and virus. The present disclosure discloses apparatus and methods whereby the use of local pressure can improve the medicinal effects of the oxygen as hyperbaric oxygen in improving wound healing and tissue repair. This can include increased collagen strength and the stimulation of new cell growth. The positive pressure application of oxygen can be in addition to any other doctor prescribed medications as oxygen can also enhances the function of antibiotics, increased neovascularization, promotes antigen and antibody function, is essential for new cell growth and promotes healing and there is very little negative reaction by prescribed medication. As provided herein, the localized application of oxygen under pressure provides for an alteration of the tissue environment from one conducive to disease to one conducive to health and healing. This environment of health and healing can be maintained by repeated application of the herein described tray and method through long-term use. 
     The pressurized direct delivery of oxygen to the infected area or wound can provide advantages that promote healthy recovery from an infection as the transcutaneous oxygen levels are increased, despite the lack of well vascularized wound tissue. These can include: a) acting as a catalyst for new healthy cell growth, promote the circulation of blood cells in infected tissue that has restrictions in the blood supply that occurs generally due to factors in the blood vessels that are in damaged or dysfunctional infected tissue, b) increasing the growth of new blood cells in the damaged tissue, c) increasing the flow of oxygenated blood to the wound to aid the healing process, d) fostering polymorphonuclear leukocyte and other infection agents functions, d) improving the vascularization of the new granulation tissue that is exposed to oxygen as the tissue heals, e) improving the tensile strength collagen being formed during wound healing, f) reducing scarring and the risk of recidivism, f) acting as a bactericidal for anaerobic bacteria present in the infected tissue (bacteriostatic effects on the biofilm). As the present methods and system provide for a new and improved topical treatment therapy, there is no systemic absorption of oxygen, and therefore no risk of pulmonary or central nervous system toxicity. Additionally, as provided herein a positive pressure oxygen therapy enhances macrophage activity, increases antibacterial effects, and increases antibiotic effects. 
     In one embodiment, a positive pressure delivery tray is configured to seals about the gums to provide a positive pressure environment (hyperbaric chamber) or treatment region within the chamber of the tray and about the enclosed teeth and gums including any infected areas. In some embodiments, a positive pressure delivery tray includes is configured with extensions and wall thickness that are bolstered to create a positive pressure within the tray and about the teeth, gums and the infected areas of the gums proximate to the teeth, such as periodontal pockets. 
     In some embodiments, positive pressure delivery tray can be made to include a positive pressure seal. Such positive pressure delivery tray seal can, in one embodiment, include a seal that is extended beyond the traditional dimensions of a medicament tray to provide a skirt that extends about and surrounds the seal. The skirt can be extended and thickened by a monolayer or bilaminar manner to provide rigidity for sealing about the gums to create the positive pressure within the treatment area within the chamber of the tray and about the enclosed teeth and gums. A port can be configured so that liquid, gel or gas can be inserted between the layers of the tray material to modify the pressure holding the tray and skirt material against the tooth and gum tissue. 
     Specific fibers can be incorporated into the tray material, seal and skirt to provide altered resiliency or to be able to conduct energy, magnetic changes or other means to enhance or modify the materials placed within the recesses of the tray which are delivered into the gingival crevice or periodontal pocket. 
     In another embodiment, positive pressure delivery tray can include a seal that is separately formed from the formation of a medicament delivery tray, but that is then bonded to the tray through an attachment process, such as by heat and pressure, or any other suitable attachment method. 
     The positive pressure tray can also be configured or formed from nontraditional medicament delivery tray materials. These new materials can include impregnated fibers or other materials as known to those skilled in the art after reading this disclosure that can add resiliency to the body of the positive pressure oxygenating tray, which may alter the energy fields within the tray, which may alter the magnetic fields within the tray or other modifications known to those skilled in these treatments. These can also be selected to provide the additional support to the overall structural integrity of the tray. 
     In some embodiments of the method and system, specialized appliances can be provided to provide a special bite relationship with a patient so that the trays are provided with a uniform contact upon closure of the mouth to be sure that the positive pressure that is provided within the treatment chamber is as equal as possible throughout the treatment chamber of the positive pressure tray. In this manner, the pressure is equal throughout the treatment chamber of the tray and the tray is not thrown off or a leak occurs due to variations in the pressure. 
     The positive pressure trays can provide the delivery of oxygen under pressure to the teeth and gums and in particular the infected gum tissue. The delivery of oxygen directly to the infected tissue can provide major tissue improvements. The positive pressure delivery tray can provide a product that generates oxygen, like ozone, or other oxidative/reduction materials directly about and to the infected area, e.g., the treatment area. 
     As described, in some embodiments a positive pressure delivery tray is configured with a body port for receiving oxygen or ozone, or other oxidative/reduction materials and retaining the doctor selected agent(s) directly about the infected gums. Of course, as one skilled in the art would understand, other embodiments can be provided that can similarly deliver the oxygenating agent to the infected gum and still be within the scope of the present disclosure. 
     The delivery of oxygen to the infected area or wound can provide advantages that promote healthy recovery from an infection. These can include acting as a catalyst for new healthy cell growth, promote the circulation of blood cells in infected tissue that has restrictions in the blood supply that occurs generally due to factors in the blood vessels that are in damaged or dysfunctional infected tissue, increases the growth of new blood cells in the damaged tissue, increases the flow of oxygenated blood to the wound to aid the healing process, fosters polymorphonuclear leukocyte and other infection agent functions, improve the vascularization of the new granulation tissue that is exposed to oxygen as the tissue heals, improves the tensile strength collagen being formed during wound healing, reduces scarring and the risk of recidivism, acts as a bactericidal for anaerobic bacteria present in the infected tissue and it has bacteriostatic effects on the biofilm. Of course, after reviewing the present disclosure, other advantages are also possible as would be recognized by those skilled in the art of wound management. 
     In one embodiment of such a method for treating periodontal disease one or more embodiments of the tray as described are fitted to a patient. 
     The method also includes applying a medicament within the recesses and creating a positive pressure within the recesses after the tray is fitted about the teeth and gums and about the medicament. 
     In another embodiment of a method for treating periodontal disease, a substantially airtight medicament tray is fitted to a patient. The tray defines a treatment chamber about the teeth and gum tissue of a patient to enclose the teeth and gum tissue. The fitted tray includes a raised seal for engaging gum tissue forming a gumline for forming a substantially airtight treatment chamber about the enclosed teeth and gum tissue. The method also includes inserting a medicament within the treatment chamber and applying a positive pressure to the substantially airtight treatment chamber and about the enclosed teeth and gum tissue. 
     The method can also include applying a biasing force to the seal against the gum tissue before or after or coincidental with the placement of the medicament within the recesses forming the treatment chamber. This can include engaging the skirt about the tray and proximate to the raised seal, injecting a positive pressure into a chamber of the tray, fitting the tray about the gum tissue with additional pressure, and applying energy to a portion of the tray to increase a stiffness of at least a portion of the tray. 
     One of the problems with prior systems and methods is that systemic oxygen delivery to the wound site is generally limited by poor wound tissue vascularization. However, topical hyperbaric oxygen as described herein can be delivered directly to the wound. As such, transcutaneous oxygen levels are increased, despite the lack of well vascularized wound tissue. As the present methods and system provide for a new and improved topical treatment therapy, there is no systemic absorption of oxygen, and therefore no risk of pulmonary or central nervous system toxicity. Additionally, as provided herein a positive pressure oxygen therapy enhances macrophage activity, increases antibacterial effects, and increases antibiotic effects. 
     When describing elements or features and/or embodiments thereof, the articles “a”, “an”, “the”, and “said” are intended to mean that there are one or more of the elements or features. The terms “comprising”, “including”, and “having” are intended to be inclusive and mean that there may be additional elements or features beyond those specifically described. 
     Those skilled in the art will recognize that various changes can be made to the exemplary embodiments and implementations described above without departing from the scope of the disclosure. Accordingly, all matter contained in the above description or shown in the accompanying drawings should be interpreted as illustrative and not in a limiting sense. 
     It is further to be understood that the processes or steps described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated. It is also to be understood that additional or alternative processes or steps may be employed.