Abstract:
A therapeutic gum irrigator is provided for subgingival periodontal irrigation with a chemotherapeutic fluid. The irrigator includes a housing surrounding at least a portion of the irrigator, a reservoir connected to the housing to retain the fluid, and a cannula configured for subgingival periodontic insertion in fluid communication with the reservoir. The irrigator further includes a neck connected to the housing and separating the reservoir from the cannula. A pump in fluid communication with the reservoir and the cannula includes a displacing element movable between first and second positions and a biasing element that biases the displacing element to the first position. A lever connected to the housing can mechanically move the displacing element to the second position, expelling a predefined volume of the fluid through the cannula. The biasing element causes the displacing element to return to the first position upon release of the thumb lever by the user.

Description:
[0001]    This application claims priority under 35 U.S.C. §119 from co-pending provisional application Ser. No. 61/628,957, filed Nov. 10, 2011. 
     
    
     FIELD OF THE INVENTION 
       [0002]    This invention relates to periodontal irrigators, and more particularly to therapeutic gum irrigators for patients&#39; home use. 
       BACKGROUND OF THE INVENTION 
       [0003]    Recent epidemiology suggests a link between periodontal health and systemic health, and several trials support this association. Research links periodontal disease to other health issues including heart disease, stroke, diabetes, pre-term low term birth weight, rheumatoid arthritis, and chronic kidney disease. Moreover, periodontal disease often results in chronic inflammatory response to bacterial infection in the periodontal pockets. 
         [0004]    An estimated 80% of adults in America have some form of periodontal disease that, if left untreated, could lead to tooth loss. Periodontal disease, including gingivitis and periodontitis, is a chronic bacterial infection that affects the gums and bone surrounding and supporting the teeth. 
         [0005]    In an initial form of periodontal disease (gingivitis), the gums redden, swell and bleed easily. If left untreated, gingivitis can lead to periodontis, which is caused by plaque bacteria spreading and growing below the gum line. This bacteria irritates the gums, which in turn stimulates a chronic inflammatory response in which the gums separate from the teeth, deepening periodontal pockets (spaces between the teeth and gums that frequently become infected), and allowing the infection to advance. 
         [0006]    Professional scaling and root planing are necessary to remove the attached bacteria from the surface of the roots. However, additional home care between professional treatments is helpful to maintain periodontal health. Traditional oral cleansing tools such as toothbrushes and dental floss are useful for maintaining periodontal health of already-healthy gums. However, these traditional tools are limited in that they generally can clean pockets only up to approximately 2-3 mm in depth. Gum inflammation, loss of epithelial attachment between the gums and teeth, and/or deterioration of the alveolar process caused by periodontitis results in deepening of the periodontal pockets, so that brushing and flossing are no longer sufficient to fully cleanse the pockets. 
         [0007]    Subgingival irrigation with an antimicrobial agent helps to disrupt bacterial colonization between professional treatments, even in relatively deep periodontal pockets. Moreover, irrigation is a useful procedure in controlling inflammation and keeping tissue healthy between professional periodontal therapies. Thus, supragingival and subgingival irrigation is effective at helping control gingivitis and periodontitis. However, the overwhelming challenge for treatment is to encourage patient compliance with regular professional and home care. 
         [0008]    Generally, research has been devoted to variable pulsing irrigation that delivers a great volume of fluid in a relatively non-directed manner that is analogous to rinsing. While such a system may be capable of delivering relatively large quantities of high-pressure fluid, it is economically impractical to employ such a system with a relatively high-cost chemotherapeutic cleansing fluid. Thus, there is a need for a delivery system that accurately delivers a precisely measured quantity of chemotherapeutic fluid in a directed manner for patient use. 
       SUMMARY OF THE INVENTION 
       [0009]    In one aspect of the present invention, a therapeutic gum irrigator is provided for subgingival periodontal irrigation with a chemotherapeutic fluid. The irrigator includes a housing surrounding at least a portion of the irrigator, a reservoir connected to the housing to retain the fluid, and a cannula configured for subgingival periodontic insertion in fluid communication with the reservoir. The therapeutic gum irrigator further includes a neck connected to the housing and separating the reservoir from the cannula. A pump is in fluid communication with both the reservoir and the cannula, and includes a displacing element movable between first and second positions, and a biasing element that biases the displacing element to the first position. A lever connected to the housing can mechanically move the displacing element to the second position, expelling a predefined volume of the fluid through the cannula. The biasing element causes the displacing element to return to the first position upon release of the thumb lever by the user. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0010]      FIG. 1  is a side plan view of an embodiment of the therapeutic gum irrigator of the present invention; 
           [0011]      FIG. 2  is a side perspective view of the therapeutic gum irrigator of  FIG. 1 ; 
           [0012]      FIG. 3  is a cross-sectional view of the therapeutic gum irrigator of  FIG. 1 ; 
           [0013]      FIG. 4  is a side plan view the therapeutic gum irrigator of  FIG. 1  disposed within a filling cup; 
           [0014]      FIG. 5A  is a bottom plan view of the irrigator and filling cup of  FIG. 4 ; 
           [0015]      FIG. 5B  is an overhead plan view of the irrigator and filling cup of  FIG. 5A ; and 
           [0016]      FIG. 6  is a rear perspective view of an alternate embodiment of the therapeutic gum irrigator of the present invention. 
       
    
    
     DETAILED DESCRIPTION 
       [0017]    A therapeutic gum irrigator for home use is described below. The irrigator allows a user to perform periodontal irrigation between visits to a treating professional. The irrigator allows for subgingival irrigation with a fluid, including a chemotherapeutic/bactericidal fluid, a fluoride-containing fluid, and/or water. Depending on the type of fluid used, the process of irrigation helps to cleanse periodontal pockets through mechanical disruption of a plaque biofilm within the cavity and/or bactericidal effect of the irrigating fluid. Moreover, the fluid may contain an anti-inflammatory and/or analgesic component to help relieve symptoms of periodontitis. The fluoride fluid component may help to desensitize root surfaces and to arrest or prevent root caries. The therapeutic gum irrigator is designed to facilitate ergonomic irrigation of a user&#39;s periodontal pockets, but may also be used by a lay person or treating professional to irrigate periodontal pockets of a patient. In this context, treating professionals include, but are not limited to, oral hygienists, dentists, periodontists, and/or oral surgeons. 
         [0018]    As seen in  FIGS. 1 and 2 , a therapeutic gum irrigator  10  has a housing  12  connected to a neck  14 . The neck  14  includes a proximal end  16  that connects the neck to the housing  12 , and a distal end  18 . A cannula  20  for subgingival application of a fluid to a user&#39;s periodontal pockets depends from the neck distal end  18 . 
         [0019]    The housing  12  is shaped such that a user can easily and comfortably manipulate the therapeutic gum irrigator  10 . Further, the housing is removably connected to and preferably at least partially surrounds a generally cylindrical reservoir  22  and a pump  24 . The housing  12  defines a fill opening  26  ( FIG. 3 ) that allows a user to fill the reservoir  22  without need to remove the reservoir. A cover  28  is hingedly attached to the housing  12  and covers the fill opening  26 . When closed, the cover  28  and housing  12  preferably form a substantially water-tight barrier to help prevent liquid from escaping the reservoir  22 . The cover  28  is preferably attached to the housing  12  via a biased hinge, such as a biased living hinge or a spring-biased barrel hinge, such that the cover  28  is biased towards a closed position. However, artisans will recognize that additional biased and non-biased hinge options are within the scope of the invention. 
         [0020]    The reservoir  22  is preferably formed from a relatively light weight, resilient material, such as plastic or acrylic, and is preferably transparent or translucent so a user can easily monitor the fluid in the reservoir. As shown in  FIG. 1 , the reservoir  22  generally defines a reservoir axis R, which passes through the center of the reservoir. 
         [0021]    The neck  14  is generally J-shaped, having a straight portion  30  adjacent to the proximal end  16 , and an arcuate portion  32  adjacent to the distal end  18 . Preferably, the neck  14  is formed from a relatively soft, resilient biocompatible acrylic, plastic, or rubber material, but those of skill in the art will recognize that any known biocompatible material may be used to form the neck. The neck  14  serves to connect the cannula  20  to the housing  12 . As shown in  FIG. 1 , the straight portion  30  defines a neck axis N passing through a center of the straight portion. The neck axis N is angled obliquely relative to the reservoir axis R. This helps to ergonomically position the cannula  20  for proper subgingival insertion. 
         [0022]    Preferably, the neck  14  is connected to the housing  12  by a rotatable coupler  34 . The coupler  34  is generally coaxial with the straight portion  30  of the neck  14 , and allows the neck to rotate about the neck axis N. This rotation may be a smooth rotation about the axis N to allow for arbitrary positioning of the neck, or there may be one or more predefined positions at which the rotation is halted, for example by detents in the rotational coupling or other known systems. The rotational coupler  34  allows for positioning of the neck  14  and cannula  20  to help allow easy, ergonomic access to all four quadrants of the user&#39;s mouth without need to rotate the housing  12 . 
         [0023]    The cannula  20  is a hollow tube formed from a resilient biocompatible material, such as metal, plastic, or acrylic. The cannula  20  is preferably generally cylindrical, though one of skill in the art will recognize that other shapes are possible without departing from the scope of the invention. The cannula  20  depends from the arcuate portion  32  of the neck  14 , and defines a cannula axis C passing through the center of the cannula. The cannula axis C is oriented such that the axis C is not parallel with the reservoir axis R or the neck axis N. Preferably, the axes C and N are approximately orthogonal, though all orientations of the axis C that are non-parallel with axes N and R are contemplated. Accordingly, an angle α is formed between the reservoir axis R and neck axis N. Similarly, an angle β is formed between the neck axis N and the cannula axis C, and an angle γ is formed between the cannula axis C and the reservoir axis R. Preferably, β is approximately equal to 90°, and α is approximately equal to 90−γ. The angles α, β, and γ are selected to help ensure that relatively difficult to reach portions of the mouth, such as distal areas of the back molars, are accessible. Accordingly, those of skill in the art will recognize that other angles may be selected without departing from the scope of the invention. 
         [0024]    The cannula  20  is sized for subgingival insertion, and to accurately direct fluid to an area selected by the user, such as a periodontal pocket. In some embodiments, the cannula may direct the fluid in a single direction. Other embodiments include side ports on the cannula, allowing for a more dispersed flow of the fluid. 
         [0025]    Turning now to  FIG. 3 , a cross-sectional view of the therapeutic gum irrigator  10  is shown. The pump  24  is preferably a single-acting, single-cylinder positive displacement reciprocating pump as shown in  FIG. 2 ; however, artisans will recognize that other pumps may be used without departing from the scope of the invention. The pump  24  is disposed such that an intake siphon  36  extends into the reservoir  22 . A pump outlet  38  is in fluid communication with the cannula  20 . The intake siphon  36  includes a one-way valve allowing fluid to flow from the reservoir  22  to the pump  24 , but preventing fluid flow in the opposite direction. Similarly, the outlet  38  includes a one-way valve allowing fluid to flow from the pump  24  to the cannula  20 , but preventing opposite-direction flow. 
         [0026]    The pump  24  further includes a displacing element such as piston  40  movable between first and second positions, and a biasing element such as biasing spring  42  biasing the piston to the first position. A mechanical actuator lever  44  is hingedly connected to the housing  12  and positioned to mechanically move the piston  40  to the second position. 
         [0027]    In operation, a user applies force to the lever  44  sufficient to overcome the biasing force of the biasing spring  42 . This user-applied force causes piston  40  to move from the first position to the second position. As the piston  40  moves, it displaces fluid in the pump, causing the fluid to be flow through the pump outlet  38  to be expelled at the cannula  20 . Once the user releases the lever  44 , the biasing spring  42  causes the piston  40  to return to the first position, inducing fluid flow from the reservoir  22  into the pump  24  via intake siphon  36 . 
         [0028]    Those of skill in the art will recognize that the volume of fluid displaced by each actuation of the pump  24  is proportional to both the cross-sectional area of the piston and the piston travel distance. Preferably, area and travel distance are selected so that the volume of displaced fluid is within a range of about 1-4 ml. However, larger and smaller volumes are contemplated. Additionally, a pressure at which fluid is expelled from the cannula  20  is a function of the selected fluid volume and a cross-sectional area of the cannula. Thus, it is preferable that the fluid volume and cannula cross-sectional area are chosen so that the pressure produced is sufficient to irrigate the pockets without causing damage to the surrounding tissue or causing undue discomfort to the user/patient. 
         [0029]    The therapeutic gum irrigator  10  can include a light source  46  positioned to illuminate at least an area surrounding the cannula  20 . The light source  46  may include one or more light emitting diodes, fluorescent bulbs and/or incandescent bulbs. Electrically coupled to the light source  46  is a power source  48  such as a battery, and an operating switch  50 . The operating switch  50  is disposed in a position to open or close a circuit including the light source and battery, thereby enabling or disabling flow of electricity from the power source  44  to the light source  46 . The switch  50  is preferably a known electrical switch such as a biased normally-open switch or a toggle switch, but those of skill in the art will recognize that other switches may be used without departing from the scope of the invention. The light source  46  is arranged near the rotatable coupler  34 . Preferably, at least portions of the neck  14  and cannula  20  are formed from a transparent or translucent material to allow for better illumination. 
         [0030]    Turning now to  FIGS. 4 ,  5 A, and  5 B, the therapeutic gum irrigator  10  preferably further includes a filling cup  52  to aid a user in filling the therapeutic gum irrigator  10 . The cup  52  is sized such that a volume of the cup is substantially similar to a volume of the reservoir  22 . Preferably, the cup  52  may include gradations indicating volume, and is preferably formed from a transparent or translucent material to easily allow a user to determine a volume of fluid contained in the cup. The cup  52  further includes a pour spout  54  having a size and shape selected to aid a user in transferring fluid from the cup to the reservoir  22  via the fill opening  26  formed in the housing  12 . Alternatively, the reservoir  22  may be detached from the housing  12  and filled directly, with or without use of the fill cup  52 . As shown in  FIGS. 5A and 5B , the cup  52  can have a tear-drop shape, with a relatively wide portion and a tapered spout  54 . This allows the cup to rest comfortably in a user&#39;s hand, while adequately directing liquid. 
         [0031]    A base  56  of the fill cup  52  is sized to accommodate a base of the reservoir  22  when the fill cup is not being used to fill the reservoir. Optionally, the base  56  may be sized to closely fit at least a portion of the reservoir  22 , such that the therapeutic gum irrigator  10  is removably engaged with the cup  52  by a frictional fit. 
         [0032]    Turning to  FIG. 6 , the housing  12  surrounding at least a portion of the therapeutic gum irrigator  10  may include a textured coating  58  to aid the user in gripping the irrigator. The coating  58  is preferably formed from a soft-touch plastic or rubber, though any material suitable for forming the housing  12  could also be used to form the coating. 
         [0033]    While the principles of the invention have been described above in connection with specific apparatus and applications, it is to be understood that this description is made only by way of example and not as a limitation on the scope of the invention.