Abstract:
A drug delivery device  10  has a support structure  20  and a medicine-laden member  100  affixed or otherwise attached to the support structure  20 . The device  10  is sized to fit into the mouth and upon exposing the medicine-laden member  100  to saliva, medicaments  101  are released into the mouth. The drug delivery device  10  permits a new method of medication delivery. The method of oral transmucosal drug delivery has the steps of providing a drug delivery device  10  that fits into the mouth, the device  10  having a medicine-laden member  100 ; wearing the drug delivery device  10 ; activating release of medicine  101  by contact with saliva; and transmitting the released medicine  101  transmucosally to the bloodstream.

Description:
TECHNICAL FIELD 
     This invention relates to an oral transmucosal drug delivery device that can be worn any time, concealed from view, preferably over the lower teeth and gums and provided with a removable medicine-laden member to deliver medicine directly into the blood stream of a patient through mucous membranes while bypassing the stomach and gastrointestinal tract. 
     BACKGROUND OF THE INVENTION 
     The most common way for administering medicine to patients is the oral route. While this route is convenient, there are some problems associated with it. For example, there is delay in absorption, and potential for side effects. Also, many drugs are absorbed abruptly, the blood levels rise quickly and just as quickly, the drug levels drop. This would lead to administering most drugs in multiple dosing to get some stability in the blood level. Sometimes this problem is circumvented by slowing the release of the drugs from the pills, in the stomach or intestines (extended or slow-release formulations). 
     Many other drugs are not suitable for the oral form as they may be rendered ineffective by the enzymes and the other components of the gastrointestinal juices. This is the case with all protein substances. Examples are Insulin and allergy shot antigens. These agents are therefore usually administered parenterally (by injection route). 
     The present invention provides a unique solution that will enable a variety of medicines to be self-administered transmucosally using a unique delivery system and device as described as follows. By formulating suitable carrier member(s) that will release drug(s) in a controlled, slow manner and then working along with higher or lower concentrations, any drug can be administered effectively. The current invention can make any drug available for absorption in a controlled manner, throughout the day and night. By making such agents available for rapid and direct absorption through the mucous membrane of the mouth, one can make all such drugs available for convenient administration. Thus, the avoidance of the pain as well as the logistics and expense of parenteral administration are special benefits of this new means of drug delivery. 
     SUMMARY OF THE INVENTION 
     A drug delivery device has a support structure and a medicine-laden member affixed or otherwise attached to the support structure. The device is sized to fit into the mouth and upon exposing the medicine-laden member to saliva, medicaments are released into the mouth. The drug delivery device permits a new method of medication delivery. The method of oral transmucosal drug delivery has the steps of providing a drug delivery device that fits into the mouth, the device having a medicine-laden member; wearing the drug delivery device; activating release of medicine by contact with saliva; and transmitting the released medicine to mucous membrane of the mouth. 
     The device is worn in the mouth preferably over the teeth and along the gums of a wearer. The device and more particularly, the support structure is a flexible open-support structure. The flexible open-support structure has two opposing bases, an inner base and an outer base. Each base extends along the length of the device and has a curvature to fit over the teeth and along the gums of a wearer of the device. The inner base fits between the teeth and the tongue while the outer base fits between the teeth and cheek and lips region of the mouth. A plurality of arch-shaped ribs extends from the inner base to the outer base joining the two bases to form the flexible open-support structure. The support structure has a means for receiving and holding the medicine-laden member for delivering a medicament transmucosally. The medicine-laden member is wetted by the production of saliva allowing the medicament to migrate into the mouth under the tongue where it is absorbed into the mucous membrane and transmitted into the bloodstream. 
     The flexible open-support structure has a connecting spine longitudinally extending between each arch rib connecting each rib along the length of the support structure. 
     The means for holding the medicine-laden member is a channel or groove extending along the length of the support structure. In a preferred embodiment the inner base has a recessed groove on a surface of the inner base extending along the length of the support structure, the groove forming the channel. In an alternative embodiment a flange is provided on the lower portion of the inner base which forms a groove or recess to hold the medicine-laden member. 
     Each inner base and outer base has a curved inner surface extending along the length of the structure, the combination of curved inner surfaces forms a flexible channel that on wearing, grips onto the outer surface of the teeth or gums. The support structure is preferably made of a flexible plastic or elastomer. The arched ribs are shaped to form a flexible spring-like enclosure of the inner base and opposing outer base, wherein upon inserting over the teeth, the bases open keeping the inner base and outer base in contact with the teeth and along the gums. 
     The plurality of arched ribs are positioned along rearward portions of the base structure which overlays the molars when worn. No arched ribs are located over regions which overlay the front teeth when worn; thus the inner and outer bases are concealed by the mouth and cheeks when the device is worn. 
     The medicine-laden member upon being wetted by saliva, releases medicaments that flow from the support structure under the tongue of the wearer. 
     The medicine-laden member for attachment in the support structure is made in the shape of a cord or string impregnated with a medicament. The medicine-laden member is made of a string or cord, the material of the string or cord being polystyrene or other natural or synthetic material suitable for being impregnated with a medicament. The medicament impregnated into the cord is releasable when exposed to saliva. The medicine is released when worn under the tongue region and delivered to the sublingual area. The types of drugs that may be administered transmucosally with the device: Insulin and its analogues; Anti-angina drugs such as the nitrates; Hormones such as the estrogens, androgens and progestogens; Pain controlling drugs such as the opiates, NSAIDs; Nicotine replacement drugs; Perhaps even vaccines (these are viral or bacterial products); and Any drug that needs repeated doses during the day. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention will be described by way of example and with reference to the accompanying drawings in which: 
         FIG. 1A  is a first perspective view of the flexible open-support structure and medicine-laden member of the drug delivery device of the present invention. 
         FIG. 1B  is a second perspective view of the flexible open-support structure and medicine-laden member of  FIG. 1A  only looking from the open end of the device. 
         FIG. 1C  is a cross sectional view of the support structure showing the two opposing inner and outer bases taken along section lines  1 C- 1 C from  FIG. 1A . 
         FIG. 1D  is a first perspective view of an alternative embodiment device of the present invention. 
         FIG. 1E  is a second view of an alternative embodiment device of the present invention, looking from above the open ends of the device. 
         FIG. 1F  is a cross sectional view of an alternative embodiment device of the present invention. 
         FIG. 2A  is a perspective end view of a row of lower teeth. 
         FIG. 2B  is a perspective end view of the device according to the present invention mounted over the lower teeth. 
         FIG. 2C  is a perspective end view of the alternative device according to the present invention mounted over the lower teeth. 
         FIG. 3  is a plan view of a set of lower teeth. 
         FIG. 4  is a plan view of the device mounted over the teeth. 
         FIG. 5A  is a cross sectional view of a version of the device. 
         FIG. 5B  is a cross sectional view of the device similar to  FIG. 5A , but with the inner base and outer base pulled apart allowing both sides of the support structure to fit over the teeth. 
         FIG. 5C  is a cross sectional view of an alternative device. 
         FIG. 5D  is a cross sectional view of the alternative device similar to  FIG. 5C , but with the inner base and outer base pulled apart allowing both sides of the support structure to fit over the teeth. 
         FIG. 6A  is a cross sectional view of the device as it appears when mounted over the front teeth taken along lines  6 - 6  of  FIG. 4 . 
         FIG. 6B  is a cross sectional view of the alternative device as it appears when mounted over the front teeth. 
         FIG. 7A  is another cross sectional view taken along lines  7 A- 7 A of  FIG. 4  showing the device has a somewhat more open cavity for fitting on the molars. 
         FIG. 7B  is a cross sectional view showing the device&#39;s appearance when open to wear over the rear teeth. 
         FIG. 7C  is a cross sectional view showing the alternative device&#39;s appearance when open to wear over the rear teeth. 
         FIG. 7D  is a cross sectional view showing the alternative device&#39;s appearance when open to wear over the rear teeth. 
         FIG. 8A  is a cross sectional view showing the device mounted over a large molar tooth in the region of an arch rib taken along lines  8 A- 8 A of  FIG. 4 . 
         FIG. 8B  is the same view as  FIG. 8A  in an open region between the arch ribs showing how the device contacts the teeth taken along lines  8 B- 8 B of  FIG. 4 . 
         FIG. 9A  is a cross sectional view showing the alternative device mounted over a large molar tooth in the region of an arch rib. 
         FIG. 9B  is the same view as  FIG. 9A  in an open region between the arch ribs showing how the alternative device contacts the teeth. 
         FIG. 10A  is a perspective exploded view showing the device with the support structure and medicine-laden member shown removed therefrom. 
         FIG. 10B  is a perspective exploded view showing the alternative device with the support structure and medicine-laden member shown removed therefrom. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     With reference to  FIGS. 1A ,  1 B and  1 C; the preferred embodiment drug delivery device  10  of the present invention is illustrated. As shown in  FIG. 1A , the device  10  has a flexible open-support structure  20 . As shown in  FIG. 1C , a medicine-laden member can be affixed to an open channel or groove  30  of the device  10 . 
     With reference to  FIGS. 1A ,  1 B and  1 C, the flexible open-support structure  20  is shown in greater detail. The flexible open-support structure  20  as shown has a pair of opposing bases  22  and  24 ; these opposing bases  22 ,  24  follow a curvature ideally suited to fit over a set of teeth either upper or lower. Connected to each base  22 ,  24  is a pair of arch-shaped ribs  26 . The ribs  26  extend outward from the base in an arch shape and connect to the other base providing a secure spring-like connection between the two opposing bases  22  and  24 . At the top surface of each arched rib  26  extends a longitudinally extending spine  28 . The optional spine  28  extends along the length of the device in the location between the arched ribs  26  connecting each arched rib  26 . Large open spaces exist between the arched ribs  26 , the spine  28  and bases  22 ,  24 . As shown, inside each base  22 ,  24  is an oval channel  29  as illustrated in  FIG. 1A  and in greater detail in  FIG. 1C . The open channel  29  is composed of two parts formed by the contour of the inside surface of the base  22 ,  24  such that when the two opposing faced bases  22 ,  24  are in contact form a complete channel  29  as illustrated. The channel  29  flexes when placed in the mouth and fitted in place over the teeth creating a gripping or suction action to help hold the device  10  on the teeth and gums. 
     As shown in  FIG. 1B  from the ends of the bases, one can easily appreciate that the device  10  is held in a spring-like fashion wherein the channel  29  is maintained closed until the bases  22 ,  24  are separated apart. 
     On each side of the inner and outer bases at the bottom of the device  10  are a pair of feet  25 . The feet  25  provide a flat surface and facilitate holding the device when placing it in the mouth. 
     As further shown in  FIG. 1B , the ends of the device  10  are clearly visibly showing the medicine-laden member  100  affixed to the inner base  22  along an exterior surface. As better illustrated in  FIG. 1C  shown in a cross sectional view the medicine-laden member  100  is shown affixed in a groove  30 . The groove  30  as shown is of circular cross section and extends along the length of the inner base  22 . The opening of the groove  30  is large enough to accept the member  100  by flexing open as the member  100  is pressed into the groove  30 . This enables the groove  30  at each end to grip onto the member preventing it from dislodging in the mouth when used by the wearer of the device  10 . 
     With reference to  FIGS. 1D ,  1 E and  1 F; an alternative embodiment device  10  is illustrated. The alternative embodiment device  10  is identical to the preferred embodiment device shown in  FIGS. 1A ,  1 B and  1 C except that the groove  30  has been replaced by a flange  27  extending from the foot  25  along the inner base  22 . The flange  27  and the inner base  22  form a groove or channel  32  into which the medicine-laden member  100  can be affixed. At an end of the flange  27  an enlarged projection  33  is shown. When placing a medicine-laden member  100  into the groove  32  the flange  27  flexes outwardly until the member  100  fully enters the channel or groove  32  wherein the flange  27  and projection  33  firmly hold the member  100  in place preventing it from dislodging. The reference numerals for the elements of both the preferred embodiment device  10  and the alternative device  10  are the same except for those features associated with securing the member  100 . For illustrative purposes both embodiments are shown in  FIGS. 5A-10B . In  FIG. 4  only the preferred embodiment device is shown, it being understood the alternative device  10  fits over the teeth in an identical manner. 
     In  FIGS. 2A and 3  an end view of a bottom row of teeth  2  and a top view looking down on the bottom row of teeth  2  are shown respectively. In  FIGS. 2B and 4  the device  10  is shown mounted on the teeth  2 . 
     In  FIGS. 5A and 5B  the preferred device  10  is shown in a cross section and in  FIGS. 5C and 5D  the same views of the alternative device are shown. These views depict how the inner base  22  and outer base  24  are expanded to fit onto the teeth  2 . 
     In the cross sectional views of  FIGS. 6A ,  6 B,  7 A,  7 B,  7 C,  7 D,  8 A,  8 B,  9 A and  9 B, the devices  10  of the preferred and alternative embodiment are shown with the medicine  101  being dispensed from the member  100 . In  FIG. 6A , the front portion of the device  10  is illustrated fitting over the front teeth  2  which are substantially narrower than the rearward-positioned molars. The teeth  2  and the device  10  extend down to the gums  4  providing a fit over the teeth  2  and along the gums  4  in this area. In  FIGS. 7A-7D  the teeth  2  are not shown. With reference to  FIGS. 8A ,  8 B,  9 A and  9 B, showing the rear portion of the devices  10  when the bases  22 ,  24  are spread apart in such a fashion that the devices  10  can fit over the shallower molars  2  which are substantially wider, therefore creating a more open appearance of the devices  10 . Again the devices  10  fit directly over the teeth  2  and along the gums  4  as illustrated. In this case, medicine  101  is shown as a dispersion spreading the medicine  101  downward past the gums  4  as the saliva activates release of the medicine  101  allowing it to migrate along the gums  4  and into a mucous membrane area under the tongue, (the tongue is not shown, to expose the mucous membrane area). 
     With reference to  FIGS. 10A and 10B , the device  10  of the preferred and alternative embodiments is shown in exploded view. The medicine-laden member  10  being removed from the support structure  20 . With particular reference to the medicine-laden member  100  it is shown formed as a string or cord  102  laden with medicine  101 . The medicine-laden member  100  for attachment in the support structure  20  is made in the shape of a cord or string  102  impregnated with a medicament  101 . The medicine-laden member  100  is made of a string or cord  102 , the material of the string or cord being polystyrene or other natural or synthetic material suitable for being impregnated with a medicament  101 . The medicament  101  impregnated into the cord  102  is releasable when exposed to saliva. The medicine  101  is released when worn under the tongue region and delivered to the sublingual membrane. The types of drugs  101  that may be administered transmucosally with the device: Insulin and its analogues; Anti-angina drugs such as the nitrates; Hormones such as the estrogens, androgens and progestogens; Pain controlling drugs such as the opiates, NSAIDs; Nicotine replacement drugs; Perhaps even vaccines (these are viral or bacterial products); and Any drug that needs repeated doses during the day. It is important to note the member  100  can be impregnated with more than one drug or medicament  101  in a combination. For example, an antihistamine and a decongestant or a blood pressure lowering medicine along with a cholesterol lowering drug could be combined. For that matter, the member  100  could be pharmaceutically prepared to match a specific patient by having a specific combination of prescribed medicines impregnated for a specific patient. In this manner, the patient simply wears the device and all required medicines can be delivered in a controlled manner without requiring multiple administrations of oral or injectables. This greatly simplifies the procedure and insures proper dosages and medicines are taken. One way to achieve multiple medicines is to have the member  100  comprised of two or more cords or threads  102  each having different medicaments  101  so these different drugs can be administered at the same time. 
     As illustrated, this device  10  is designed to be worn any time. It can be worn over a period of several hours due to the pliant nature of the open support structure  20 . The device  10  is adapted to be minimally invasive and of such light weight that the wearer can wear it comfortably without hampering his or her ability to eat or talk. As shown, the device  10  is mounted preferably on the lower set or row of teeth  2 . As shown, the device  10  provides an excellent means for providing prolonged treatment with otherwise injectable or erratically absorbed medicines. This is of particular value in that most medicaments cannot currently be provided or applied over a period of time. The present invention provides an ideal means for providing the medicaments over an extended period of time. This is particularly important as it makes it possible for the wearer to get an extended treatment heretofore unavailable. This feature is particularly useful when treating chronic conditions such as diabetes with insulin. Antibiotics and other medicines can be used with this device  10  which can make the treatment shorter in overall duration and more effective, possibly eliminating the need to administer the antibiotics systemically by way of pills taken orally or injections. The present invention, as designed is molded to the shape of the open support structure  20 . 
     Variations in the present invention are possible in light of the description of it provided herein. While certain representative embodiments and details have been shown for the purpose of illustrating the subject invention, it will be apparent to those skilled in this art that various changes and modifications can be made therein without departing from the scope of the subject invention. It is, therefore, to be understood that changes can be made in the particular embodiments described, which will be within the full intended scope of the invention as defined by the following appended claims.