Intra-oral device for treating obesity

Abstract

The present invention relates to an intra-oral device including a carrier that has an outside wall, an inside wall and an occlusal wall connecting the outside wall to the inside wall. The carrier has at least one inset and at least one insert carrying a beneficial agent that is adapted to fit the inset, and the beneficial agent is capable of promoting weight loss. The intra-oral device is positioned in a user's mouth so that the intra-oral device is in contact with the user's cheeks, lips and/or tongue and the beneficial agent passes through the mucosal membrane of the user's mouth.

1 . An intra-oral device comprising: 
 a carrier having an outside wall, an inside wall and an occlusal wall connecting said outside wall to said inside wall, said carrier having at least one inset and at least one insert carrying a beneficial agent adapted to fit said inset, wherein said beneficial agent is capable of promoting weight loss.    
   
   
       2 . The intra-oral device of  claim 1  wherein said insert comprises a hydrogel.  
   
   
       3 . The intra-oral device of  claim 1  wherein said beneficial agent has time release properties.  
   
   
       4 . The intra-oral device of  claim 1  wherein when said device is positioned in a user's mouth, said insert is in contact with a mucosal membrane of said user's mouth so that said beneficial agent passes through the mucosal membrane.  
   
   
       5 . The intra-oral device of  claim 4  wherein said mucosal membrane is selected from the group consisting of the buccal membrane or the sublingual membrane.  
   
   
       6 . The intra-oral device of  claim 1  wherein said insert is adapted to be in contact with a mucosal membrane of a user's mouth so that said beneficial agent is delivered systemically when said device is positioned in the user's mouth.  
   
   
       7 . The intra-oral device of  claim 1  wherein said insert is adapted to be in contact with a mucosal membrane of a user's mouth so that said beneficial agent is delivered locally when said device is positioned in said user's mouth.  
   
   
       8 . The intra-oral device of  claim 1  wherein said beneficial agent is an appetite suppressant.  
   
   
       9 . The intra-oral device of  claim 8  wherein said appetite suppressant is selected from the group consisting of Cholecystokinin (CCK), Bombesin/Gastrin-Releasing Peptide (GRP), Enterostatin, Glucagon-like peptide 1 (GLP-1), neuropeptide-Y, Galanin, Orexin, cocaine- and amphetamine-regulated transcript (CART), Melanocortins, serotonin (5-HT), noradrenaline (NA), and leptin.  
   
   
       10 . The intra-oral device of  claim 1  wherein said beneficial agent provides a gustatory or aromatic stimulant.  
   
   
       11 . The intra-oral device of  claim 1  wherein said beneficial agent is capable of decreasing food absorption.  
   
   
       12 . The intra-oral device of  claim 1  wherein said beneficial agent is selected from the group consisting of chitosan, guar gum, plantago husk, alfalfa, bladderwrack and ginger root.  
   
   
       13 . The intra-oral device of  claim 1  wherein said beneficial agent is adapted to cause a physical change in the body that is expected to result in weight loss.  
   
   
       14 . The intra-oral device of  claim 1  wherein said beneficial agent is adapted to cause a change in the behavior of the user that is expected to result in weight loss.  
   
   
       15 . The intra-oral device of  claim 1  wherein said outside wall is provided with an opening adapted to expose at least one of a user's teeth.  
   
   
       16 . A method for the treatment of humans for weight loss and/or weight management comprising: 
 positioning an intra-oral device having a carrier wherein said carrier has at least one inset and at least one insert adapted to fit said inset in the oral cavity so that said insert is in contact with a mucosal membrane of said human and said insert carries a beneficial agent capable of promoting weight loss.    
   
   
       17 . The method of  claim 16  wherein said insert comprises a hydrogel.  
   
   
       18 . The method of  claim 16  wherein said beneficial agent has time release properties.  
   
   
       19 . The method of  claim 16  wherein said beneficial agent is an appetite suppressant.  
   
   
       20 . The method of  claim 19  wherein said appetite suppressant is selected from the group consisting of Cholecystokinin (CCK), Bombesin/Gastrin-Releasing Peptide (GRP), Enterostatin, Glucagon-like peptide 1 (GLP-1), neuropeptide-Y, Galanin, Orexin, cocaine- and amphetamine-regulated transcript (CART), Melanocortins, serotonin (5-HT), noradrenaline (NA), and leptin.  
   
   
       21 . The method of  claim 16  wherein said beneficial agent provides a gustatory or aromatic stimulant.  
   
   
       22 . A method of promoting weight loss and/or weight management in humans comprising: 
 positioning an intra-oral device over an arch of teeth of a user when said user has the desire to eat, wherein said intra-oral device includes a carrier having an outside wall, an inside wall and an occlusal wall connecting said outside wall to said inside wall; and    removing said intra-oral device from said user's mouth when said user determines that said user's desire to eat is extinguished.    
   
   
       23 . The method of  claim 22  wherein said intra-oral device provides a gustatory or aromatic stimulant.  
   
   
       24 . The method of  claim 22  wherein said intra-oral device is imbibed with a solution comprising a gustatory or aromatic stimulant.  
   
   
       25 . An intra-oral device adapted to be positioned over an arch of a human's teeth comprising: 
 a carrier having an inset receiving an insert carrying a beneficial agent to be discharged from said insert and at least one perforation in said carrier whereby at least a portion of said beneficial agent passes through said perforation when said beneficial agent is discharged from said insert.    
   
   
       26 . The intra-oral device of  claim 25  wherein said carrier has an outside wall, an inside wall and an occlusal wall connecting said outside wall to said inside wall, said carrier further including a wing extending from said inside wall.  
   
   
       27 . The intra-oral device of  claim 25  wherein said carrier has a plurality of perforations.  
   
   
       28 . The intra-oral device of  claim 26  wherein said perforation is located at the position of the inset.  
   
   
       29 . The intra-oral device of  claim 26  wherein said perforation is located on said wing.  
   
   
       30 . The intra-oral device of  claim 25  wherein said beneficial agent comprises a chemical, therapeutic agent, medication, pharmaceutical or nutraceutical.  
   
   
       31 . The intra-oral device of  claim 25  wherein said beneficial agent is capable of promoting weight loss.  
   
   
       32 . The intra-oral device of  claim 26  wherein said outside wall is provided with an opening adapted to expose at least one of said human's teeth.  
   
   
       33 . A method of delivering a beneficial agent comprising: 
 placing an intra-oral device in the oral cavity wherein said intra-oral device includes a carrier having an outside wall, an inside wall and an occlusal wall connecting said outside wall to said inside wall, said carrier having at least one inset and at least one perforation at the position of the inset, and at least one insert carrying a beneficial agent adapted to fit said inset;    applying pressure to said intra-oral device with a user's tongue to cause a discharge of said beneficial agent through said perforation.    
   
   
       34 . The method of  claim 33  wherein said outside wall is provided with an opening adapted to expose at least one of a user's teeth.  
   
   
       35 . The method of  claim 33  wherein said beneficial agent comprises a chemical, therapeutic agent, medication, pharmaceutical or nutraceutical.  
   
   
       36 . The method of  claim 33  wherein said beneficial agent is capable of promoting weight loss.  
   
   
       37 . The method of  claim 33  wherein said carrier further comprises a wing extending from said inside wall.  
   
   
       38 . The method of  claim 37  wherein said wing has an inner surface and an outer surface and said inset is located on said inner surface of said wing.  
   
   
       39 . An intra-oral device adapted to be positioned over an arch of a human's teeth comprising: 
 a carrier having an inset adapted to receive an insert, wherein said carrier has an outside wall provided with an opening adapted to expose at least one of said human's teeth when said device is positioned over said arch.    
   
   
       40 . The intra-oral device of  claim 39  further including an insert carrying a beneficial agent to be discharged from said insert.  
   
   
       41 . The intra-oral device of  claim 40  wherein said insert comprises a hydrogel.  
   
   
       42 . The intra-oral device of  claim 40  wherein said beneficial agent comprises a chemical, therapeutic agent, medication, pharmaceutical or nutraceutical.  
   
   
       43 . The intra-oral device of  claim 40  wherein said beneficial agent is capable of promoting weight loss.  
   
   
       44 . The intra-oral device of  claim 39  wherein said carrier further includes an inside wall and an occlusal wall connecting said outside wall to said inside wall and said device further comprises a wing extending from said inside wall.  
   
   
       45 . The intra-oral device of  claim 44  wherein said wing includes at least one perforation.