Patent Application
20110270053
The present invention generally relates to the field of behavior modification and devices and systems thereof, and more particularly to apparatus and methods for assisting a user in cessation of undesired behaviors involving intake of substances through the oral pathway.
Certain persons may engage in certain undesirable activities that have significant negative acute and/or long-term health, social, safety and financial implications for the person and for others associated with the person. In some cases, the person may wish to quit this behavior. Often, the person's family, friends, and/or healthcare providers are also engaging with the person in an attempt to have them quit the behavior. Often, such associated persons may also be negatively impacted by the behavior, socially, financially, and from a health perspective. Behavioral modification or cessation attempts to terminate the undesirable behavior may be formal and administered by healthcare professionals, or the person may take their own personalized approach to cessation. Either way, there is a role for a means to facilitate and optimize the success rate of the cessation process, as presently cessation programs have high acute failure rates and high recidivism rates.
A number of undesirable behaviors that involve smoking of one or more substances, oral ingestion of one or more substances, absorption via the gastrointestinal tract of one or more substances, oral placement of one or more substances, transdermal absorption of one or more substances, nasal sniffing of one or more substances, inhaling of one or more substances, intravenous injection of one or more substances, and other methods of absorbing one or more substances result in the subsequent presence of one or more of the substances or their metabolites in the exhaled breath, oral mucosa, and/or secreted saliva of the person either immediately or sometime after use of the substance. The presence of a unique substance or substances in the exhaled breath, oral mucosa, and/or secreted saliva can be detected in the intra-oral space and can then be used as a surrogate marker for the specific undesirable behavior. Passive and constant monitoring of the intra-oral space for presence of these surrogates would enable one to determine if the user was participating in the undesirable behavior, and could additionally quantify the amount of the behavior based on the amount of detected substance(s).
Exemplary embodiments of the present invention include a device or system capable of detecting substances within the oral cavity as an adjunct to achieving cessation of an undesirable behavior and/or maintaining abstinence after successfully quitting an undesirable behavior. Such embodiments may comprise at least one passive detector unit disposed in the oral cavity capable of detecting one or more substances indicative of the undesirable behavior, at least one anchoring means by which to secure the detector unit within the oral cavity, and, in some cases, a platform which interconnects the detector and anchor.
In various alternative embodiments, a detector is capable of detecting one or more substances of interest within inhaled gas and particulates, exhaled gas and particulates, intra-oral gasses (volatilized substances), ingested liquids and solids, intra-oral mucous, secreted saliva, and other means. Such a detector may be capable of detecting intra-oral substances indicative of smoking behavior including smoking of tobacco via cigarettes, pipes, cigars, and water pipes and smoking of illegal products such as marijuana, cocaine, heroin, and others. In other embodiments, the detector may be capable of detecting intra-oral substances indicative of the oral ingestion of certain substances, such as alcohol, caffeine-containing products, sugars, prescription drugs in excess, illegal drugs, and other substances. Alternative detectors may be capable of detecting intra-oral substances indicative of oral placement of certain substances, including but not limited to placing chewing tobacco and snuff in the oral cavity. Other detectors suitable for use in embodiments of the invention may be capable of detecting intra-oral substances indicative of transdermal absorption of certain substances, including but not limited to application on the skin of certain creams, ointments, gels, patches or other products that contain drugs of abuse, such as narcotics, LSD, steroids, and others. Still other detectors may be capable of detecting intra-oral substances indicative of nasal sniffing of drugs or substances of abuse, which include but are not limited to sniffing cocaine or sniffing glue, or capable of detecting intra-oral substances indicative of intravenous injection of drugs.
In other alternative embodiments the anchor means may comprise one or more bone screws inserted into the maxilla or mandible or both, a dental veneer affixed to one or more tooth surfaces, an orthodontic band or bracket, an orthodontic retainer, or other such device that is affixed to the dental enamel or encircled around one or more teeth, a retainer that is molded to fit over the dentition, such as a clear mouth guard or clear orthodontic retention device.
In exemplary embodiments the anchor means, detector unit, and platform may be distinct components or any two or more may be integrated into common components.
Exemplary embodiments of the invention may employ detector units that indicate the presence of a substance of interest qualitatively, such as by color change, or quantitatively. Such qualitative detectors may present a color change upon exposure to one or more substances of interest, with the following variables: color change can be either irreversible, spontaneously reversible, or reversible upon exposure to a certain specially designed medium such as a light, liquid or chemical; color change may occur upon exposure to any amount of the substance of interest (binary, positive or negative) or may have a pre-determine threshold at which the color change may occur which may range from very low levels of exposure to very high levels of exposure; color change may be variable in that more severe exposures are cue color or one color density, while other levels of exposure are a different color or a different color density; reversible colorimetric detectors may change color upon any preset level of exposure to a substance of interest, but then may return to the baseline level over a predetermined period of time as exposure to the substance is decreased or ceased; baseline color of colorimetric detector may be unobtrusive, such as white or clear or pink, and the detector may be worn in a location in the intra-oral space that is visible (upper incisors and canines) to the user and user's acquaintances, so that when the detector changes color the user and others will be aware that they are engaging in the undesirable behavior, and/or in non-reversible embodiments; the color change with additional exposure can be cumulative, therefore the amount of color change can be quantifiable and related to the amount of longitudinal exposure to the substance of interest. Quantitatively based detectors may be capable of quantifying the amount of substance exposure over time when removed and analyzed at periodic intervals during monitoring, such as every week.
Other exemplary embodiments of the invention include methods for facilitating cessation of an undesirable behavior, or ensuring prolonged abstinence from an undesirable behavior, by passively and continually monitoring for and detecting the presence of substances within the intra-oral space that are indicative of that undesirable behavior. Exemplary embodiments may comprise providing one or more intra-oral detectors that reside within the intra-oral cavity, retaining the detectors within the oral cavity, exchanging the detectors and other portions of the device as needed, and/or testing detectors for qualitative and/or quantifiable evidence of longitudinal exposure to substances of interest.
In further exemplary embodiments of the present invention, detectors as disclosed may be used within a formal behavior modification program, such as a smoking cessation program or an alcohol-dependency program, to facilitate cessation of an undesirable behavior. Such devices may be used independently by the user to facilitate a self-motivated behavior modification program, or as fixed by a health care professional if compliance is more problematic, to facilitate cessation of an undesirable behavior. As one further example, monitoring for a substance of interest according to embodiments of the present invention may be employed after successfully completing a cessation program to objectively confirm abstinence as well as to objectively monitor for recidivism.
For the purpose of illustrating the invention, the drawings show aspects of one or more embodiments of the invention. However, it should be understood that the present invention is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein:
Embodiments of the present invention comprise methods, devices and systems for use in detecting a number of substances that may be present, whether constantly or intermittently, in the oral cavity and indicative of specific undesired and/or unhealthy behaviors. Methods, devices and systems according to embodiments of the present invention enable constant passive monitoring for these substance and their related undesired behaviors, and therefore may aid in the cessation of said behaviors via a number of positive and negative feedback mechanisms, as well as via providing additional diagnostic information to the healthcare provider regarding response to therapy.
A variety of different behaviors may be targeted by embodiments of the present invention. Examples include smoking, oral ingestion, oral placement, transdermal absorption involving oral pathways, nasal inhalation, and/or intravenous injection of various substances. Some more specific examples of smoking behaviors include but are not limited to smoking of tobacco via cigarettes, pipes, cigars, and water pipes and smoking of illegal products such as marijuana, cocaine, heroin, and others. Oral ingestion may involve substances such as alcohol, caffeine-containing products, sugars, prescription drugs in excess, illegal drugs, and other substances. Oral placement may involve substances and behaviors such as placing chewing tobacco and snuff in the oral cavity. Transdermal absorption may involve application on the skin of certain creams, ointments, gels, patches or other products that contain drugs of abuse, such as narcotics, LSD, steroids, and others. Nasal inhalation is a common behavior commonly associated with substances of abuse, including but not limited to sniffing cocaine or glue products.
In general, embodiments of the present invention are configured to detect substances within the oral cavity that are surrogate markers for a behavior that is determined to be undesired or otherwise to be treated. Such marker substances may be present in the oral cavity due to one or more of the following distinct mechanisms:
1) In the case where a product is ignited and the subsequent smoke plume drawn into the mouth and lungs, the particulate and chemical matter containing the substance(s) of interest is deposited in part onto the oral mucosa and dentition, retained within the saliva and mucous, and deposited on or within other objects in the oral cavity.
2) In the case where a previously inhaled plume of smoke resulted in the substance being absorbed into the body and bloodstream via the lungs and then released from the bloodstream back into the pulmonary airspace for exhalation, the substance of interest is deposited in part onto the oral mucosa and dentition, retained within the saliva and mucous, and deposited on or within other objects in the oral cavity.
3) In the case of inhaling a plume of smoke, a portion of the plume enters only the pulmonary dead space (non-absorbing portion of the pulmonary air space) and is exhaled immediately through the oral cavity without absorption of the substance(s) into the bloodstream. In this case, the substance of interest is deposited in part onto the oral mucosa and dentition, retained within the saliva and mucous, and deposited on or within other objects in the oral cavity.
4) In the case where the substance is present in the oral cavity as a result of oral ingestion or oral placement of certain products containing the substance(s), the substance(s) of interest is deposited in part onto the oral mucosa and dentition and retained within the saliva and mucous as it is being swallowed or rinsed around in the mouth, and deposited on or within other objects in the oral cavity.
5) In the case where the substance was previously absorbed into the body and bloodstream via oral ingestion via the gastrointestinal system, oral placement, nasal sniffing, inhalation via the lungs, trans-dermal absorption, intravenous injection or other routes, the substance of interest is released from salivary glands into the oral cavity deposited in part onto the oral mucosa and dentition, retained within the saliva and mucous, and deposited on or within other objects in the oral cavity.
In general, devices according to embodiments of the present invention are placed and retained within the oral cavity of a user. The term “device” is used collectively herein to refer to the entire unit (or units) that is/are disposed within the oral cavity. As described in more detail herein below, exemplary embodiments of the present invention may have one or more of any of the following sub-units, such as: an anchoring component for affixing to a structure, a detector unit for passively monitoring for a substance of interest, and a platform upon which to interconnect the detector and anchoring component. The anchor device may be a bone screw, a wire, an orthodontic bracket, a dental veneer, an orthodontic band, a semi-permanently attached retainer, an arch wire, a palatal arch structure, a dental cap, a dental insert, a dental clasp, or other such means. When affixing an anchor to the dental enamel, various light-cured and non-light cured adhesives may be used or clasps with pressure fits may be used. The bone screws could be inserted in the mandible or maxilla in various locations. The platform and detectors may be attached to one or more anchors in the oral cavity and the latter may be positioned in one or more locations within the oral cavity.
Preferably, devices according to embodiments of the present invention are configured to substantially remain in the oral cavity during the period of monitoring for the substance that is the surrogate marker for the targeted behavior. In certain embodiments, the device will remain in the oral cavity for the complete monitoring interval. This may be accomplished voluntarily with a device that can be taken in and out of the oral cavity by the user, with the assumption that the user will comply and keep the device in place during the majority of the monitoring interval, or involuntarily with a device that is at least semi-permanently attached within the oral cavity and is not able to be removed by the user. In some embodiments, the user may be able to intermittently remove the device for cleaning and other processes. However, it is generally contemplated that embodiments that do not permit user removal, or at least do not facilitate user removal, will provide more optimal and constant monitoring for undesirable behaviors.
When disposed within the oral cavity, at least a portion of a device, specifically the detector portion, is exposed to the oral cavity milieu, which includes saliva, exhaled breath, inhaled substances, volatilized substances, food, liquids, etc. The detector portion of the device is therefore exposed to the substance of interest within the oral cavity via the multitude of mechanisms disclosed earlier in this patent application.
In some embodiments, the device may be placed in the oral cavity by the user without the need for a healthcare professional to semi-permanently affix the device. In this case, the user may exchange all or portions of the device (such as the detector sub-unit) as required at regular intervals and/or may be able to remove all or portions of the device intermittently to clean the oral cavity and the device. Such an embodiment may reduce the ability to monitor 100% of the time interval of interest for a user, however, with many of the substances of interest, prior behaviors can be detected in subsequent sampling of the oral cavity milieu, as in the example of carbon monoxide detection hours after smoking a cigarette. Therefore, intermittent removal of the device should not substantially limit the effectiveness of the device in monitoring for surrogate markers of undesirable behavior. Alternatively, or additionally, a separate detector unit may be included that is indicative of residence time in the oral cavity, for example by indicating a qualitative change correlated to an amount of exposure to naturally occurring substances in the saliva such as particular enzymes.
Referring now to
In one alternative embodiment, plastic body 12 is partly or wholly comprised of or includes a material that also provides the function of detector units 14 (and/or detector 16) to detect the substance of interest. In such embodiments, plastic body 12 serves as the detector unit as well as the platform and anchor means.
Retainer-based embodiments, such as exemplified in
Further alternative embodiments of the present invention, as illustrated in
Turning to
In further exemplary embodiments of the present invention, one or more bone screw anchors may be placed in the maxilla and/or mandible, upon which are disposed locking platforms that lock onto the screws. Detector units may be disposed on the platform or may be incorporated in the platform itself. The detector units may also be incorporated directly into the anchor system, as with a dental veneer. In this type of embodiment, the detectors may only be changed by the healthcare professional as needed for testing and renewal of the material. In another exemplary embodiment, as described in more detail below and shown in
Each detector unit may be configured to detect one or more substances of interest as is appropriate for a particularly devised treatment regimen. If only one substance of interest is targeted (for example carbon monoxide to detect smoking behavior) using one or more detectors specific to that substance could be used. Alternatively, if more than one substance of interest is targeted (for example carbon monoxide to detect smoking behavior and ethyl alcohol to detect alcohol consumption), then multiple detectors each sensitive to only one substance could be used or one detector sensitive to multiple substance could be used.
There are various mechanisms by which the detectors detect a substance of interest. In one exemplary embodiment, the detector units present a color change when exposed to a substance of interest. Such color change could occur upon exposure to any level of the substance or to a specific pre-set threshold. Such color change could be reversible or irreversible. In another embodiment, the detector would be removed after a certain period of time and the color change detected and/or quantified by a healthcare provider. A new detector would be installed at each test visit for refreshed monitoring over the next period of time.
In one exemplary embodiment of a color-change based detector, carbon monoxide may be detected by materials wherein exposure to carbon dioxide induces color change. Such materials are known in the art; for example synthetic hemoglobin utilized in biomimetic CO sensors, and a number of other materials such as disclosed in U.S. Pat. No. 5,618,493, entitled Photon Absorbing Bioderived Organometallic Carbon Monoxide Sensors, which is incorporated by reference herein in its entirety.
In other exemplary embodiments, available colorimetric sensor materials may be employed to indicate the presence of other markers for other undesired behaviors. For example U.S. Pat. No. 4,900,666, which is incorporated herein by reference in its entirety, discloses a Colorimetric Ethanol Analysis Method and Test Device, including a test material that may be readily adapted for use as an alcohol sensor in an embodiment of the present invention. Known materials that provide colorimetric tests for cyanide (associated with cigarette smoking), such as pyridine-pyrazolone, may be used as sensors for many different smoked compounds that contain some amount of cyanide when burned. Colorimetric strip-based test materials also exist for compounds such as nicotine, arsenic, THC and cocaine, which also may be readily adapted for use in the present invention by persons of ordinary skill in the art.
Known detector kits for a variety of reagents also may be adapted for use with embodiments of the present invention by persons of ordinary skill in the art based on the teachings contained herein. Examples of such kits are disclosed in, for example, U.S. Pat. No. 5,063,164, entitled Biomimetic Sensor that Simulates Human Response to Airborne Toxins, U.S. Pat. No. 5,728,350 entitled Chemical or Microbiological Test Kit, U.S. Pat. No. 5,035,860, entitled Detection Strip for Detecting and Identifying Chemical Air Contaminants and Portable Detection Kit Comprising Said Strips, and US Patent Application Pub. No. 2009/0253220, entitled Absorbing Biomolecules into Gel-Shell Beads, each of which is incorporated by reference herein in its entirety.
Sensor materials as described above may be incorporated into detector units compatible with the oral environment in a number of ways as may be derived by persons of ordinary skill in the art based on the teachings contained herein. For example, the sensor material may be protected from the oral environment by a gas permeable, liquid impermeable barrier to permit gasses of interest that are present within the oral cavity to contact the sensor while isolating it from liquids in the oral cavity. Such gas permeable, liquid impermeable materials suitable for barrier membrane for protecting sensor materials according to the present invention are well known in the art. Examples of such materials are disclosed in U.S. Pat. No. 3,953,566, entitled Process for Producing Porous Products, and U.S. Pat. No. 4,904,520 entitled Gas-Permeable, Liquid-Impermeable Nonwoven Material, each of which is incorporated by reference herein in its entirety. Persons of ordinary skill in the art will be able to select other suitable barrier materials in addition to those described in the incorporated patents. However, sensors that work based on liquid contact may not require such protection. Alternatively, a porous porcelain substrate may be impregnated with sensor material to form a solid matrix that is biocompatible and safe for placement in the oral cavity while presenting an outer surface that is responsive to the presence of carbon monoxide. By forming a porcelain matrix such detector units may be secured to teeth, bone or substrate platforms using conventional dental materials, adhesives and processes well understood by persons in the art.
In the embodiments described in the preceding paragraph, the color change in the detector units may be configured to be irreversible. In an alternative exemplary embodiment, the detector unit may be constructed to provide a reversible color change when exposed to a substance of interest. Such reversible detectors may be made from synthetic hemoglobin to provide a reversible colorimetric sensor for the presence of carbon monoxide as is well known in the art.
With reversibly-colorimetric detector units, the material may change color upon a certain amount of smoke exposure, but will then slowly revert to normal color when exposure to smoke is decreased or avoided for a predetermined period of time. In this case, the user will have constant feedback about the amount of smoking that they are engaging in and will be constantly reminded that they are “over their limit”. Such a constant reminder will allow the user to immediately modify their behavior so as to allow the sensors to return to the normal color. In the case of irreversible colorimetric detectors, variable sensitivity of the material to carbon monoxide will allow tailoring of the monitoring and feedback for each patient. For example, in early phases of a smoking cessation program, the permanent colorimetric change may occur after smoking 100 cigarettes. With each exchange of the sensor units (weekly, for example), a more sensitive material is used, thereby allowing less and less smoking behavior before the colorimetric change occurs. By week eight, for example, the sensors change color after only ten cigarettes are smoked. By week twelve, the sensors change color after one cigarette is smoked.
In embodiments of the invention employing a reversible colorimetric detector unit, the variability in sensitivity to smoke exposure may be tailored according to the “time” and amount of exposure required to make a change, as well as the time with no smoke exposure required to return to normal. In one exemplary embodiment, the detector material, for example a hemoglobin disk, is a highly sensitive material that changes color relatively quickly upon exposure to cigarette smoke, and then requires a significant period of time, such as four to eight hours, or about six hours, of smoke-free (carbon monoxide free) environment before returning to normal.
In a further exemplary embodiment, detector units capable of quantifying longitudinal exposure to a substance of interest (e.g., carbon monoxide) may be employed alone or in combination with a visual detector such as a colorimetric detector unit as described above. This adjunctive monitoring device allows the healthcare professional to quantify exposure to carbon monoxide and therefore estimate smoking behavior during the monitoring interval. For example, the units may contain certain gel compounds, as described above, which absorb certain constituents of smoke over time or a passive computer chip capable of monitoring for carbon monoxide. When removed from the mouth and analyzed, the quantity of the smoke substance exposure can be compared to the time that the units were worn in the mouth, and a predictive algorithm used to estimate the number of cigarettes smoked during the entire time the units were worn (or converted to a cigarettes-per-day basis).
By utilizing quantitative detectors in conjunction with qualitative detectors, the patient would preferably be enrolled in an ongoing treatment program. For example, the patient would visit the smoking cessation program on a regular basis (i.e., weekly) at which time the detector units are removed and replaced with new ones. The old units are analyzed for quantitative evidence of smoking exposure according to time worn. This provides the healthcare provider with objective evidence of smoking behavior for the patient. Detector units used for quantifying exposure to a substance also need not be placed in visibly apparent portions of the oral cavity. Rather, they can be placed in discrete regions, such as on platform 24 of retainer 20 in
In one exemplary embodiment of the present invention, as illustrated in
Thus, in the exemplary embodiment of
If the detector material is irreversibly colorimetric, an option at each smoking-cessation visit is to remove the detectors and replace them with fresh detectors that have not been exposed to smoke. In this irreversible colorimetric embodiment, the user begins with a clean set of detector units at each visit and is reinvigorated and re-motivated to avoid smoking to avoid future undesirable color changes. If the user knows that they will be changing the units at some regular interval, even if they fail in one week, they can restart the clock with new units and try again. This reward/penalty system may improve compliance with the smoking cessation program.
When using colorimetric detectors as described herein, the change in color may involve the entire surface of the detector or it may be limited to certain portions of the detector, so as to spell out words or create images when activated, as illustrated by detector units 70a-f in
In a further alternative embodiment, as shown in
The various alternative and exemplary embodiments described herein present methods and devices that are well adapted to and may be used in conjunction with a formal behavioral cessation program, such as a smoking, drug, or alcohol cessation program staffed by healthcare professionals and in which drug and counseling therapies are utilized. In such cases where the patient is participating in a fully-supported program, these methods and devices would serve as adjuncts to currently accepted therapies in that they would provide detection of undesirable behavior during unmonitored time periods. This would provide the healthcare professional with additional information not normally available regarding patient compliance during unmonitored intervals. Such additional information would allow the healthcare provider to adjust therapy according to patient response, thus optimizing therapy and increasing efficacy. Such additional information allows more optimized care and tailoring of therapy. These methods and devices would provide positive and negative feedback to the user, and accountability for them to adhere to their program.
Alternatively, these methods and devices may be used independently by a patient who is not participating in a formal behavioral modification program. Such a patient may be self-motivated and may wish to have additional incentive or assistance in quitting the specific undesirable behavior, without outside assistance. These methods and devices would provide positive and negative feedback to the user, and accountability for them to adhere to their program.
Alternatively, these methods and devices may be used after completion of a cessation program once the behavior has been purportedly extinguished. In this use, the monitoring can provide objective evidence to confirm that the behavior has been extinguished and can provide long-term monitoring to increase the likelihood of maintaining abstinence (avoiding recidivism).
Exemplary embodiments have been disclosed above and illustrated in the accompanying drawings. It will be understood by those skilled in the art that various changes, omissions and additions may be made to that which is specifically disclosed herein without departing from the spirit and scope of the present invention.
This application claims the benefit of priority of U.S. Provisional Patent Application Ser. No. 61/255,427 filed Oct. 27, 2009, and titled Intra-Oral Devices and Methods, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 61255427 | Oct 2009 | US |
