CN-115515505-B - Saliva collection and testing system

Abstract

A system having a saliva sampling device configured to be worn by a patient's mouth. The saliva sampling device is a polymer holder or a polymer orthotic. The saliva analysis engine is to correlate one or more analytes of one or more saliva samples with one or more health attributes. The health monitoring engine updates the health profile of the patient based on the associated health attributes.

Inventors

• Lungitt Menon
• Lotz pan
• Nicole Garcia

Assignees

• 斯米利奥公司

Dates

Publication Date

20260505

Application Date

20201107

Priority Date

20191107

Claims (18)

1. 1. A health monitoring system, comprising: One or more processors; a memory coupled to the one or more processors, the memory containing instructions that when executed by the one or more processors cause the one or more processors to: receiving data for at least one analyte from at least one saliva sample, the saliva sample collected by a saliva sampling device configured to be wearable by a patient's mouth, wherein the saliva sampling device comprises one of a polymer holder and a polymer orthotic; Associating at least one analyte of the at least one saliva sample with at least one health attribute, wherein the at least one saliva sample is collected by the saliva sampling device over a plurality of days during incremental wear of the saliva sampling device by the patient, wherein the at least one saliva sample is collected by the saliva sampling device for one or more time periods initiated by a user operation of the saliva sampling device capable of collecting saliva, wherein the user operation comprises removing a cover located at a storage access location on the saliva sampling device, and updating a health profile of the patient based on the at least one health attribute.
2. 2. The system of claim 1, wherein the health profile comprises at least one profile of at least one health condition, and wherein the at least one health attribute is used to update at least one status profile.
3. 3. The system of claim 1, wherein the health profile comprises at least one risk profile for at least one disease, and wherein the at least one associated attribute is used to update the at least one risk profile.
4. 4. The system of claim 1, wherein the health profile comprises at least one nutritional profile of at least one nutritional aspect, and wherein the at least one health attribute is used to update the at least one nutritional profile.
5. 5. The system of claim 1, wherein each incremental wear period is at least one hour.
6. 6. The system of claim 1, wherein the at least one saliva sample is one of a plurality of saliva samples collected by the saliva sampling device over a plurality of days.
7. 7. The system of claim 1, wherein the at least one health attribute is processed to provide one or more of nutritional information, disease information, hormonal information, and genetic information.
8. 8. The system of claim 7, wherein the nutritional information includes one or more of hydration information, PH information, fluoride information, mineralization information, alcohol information, and microbiome information.
9. 9. The system of claim 7, wherein the disease information comprises one or more of infectious disease information, cancer information, inflammation information, and virus information.
10. 10. The system of claim 1, wherein the at least one analyte comprises at least one biomarker of the at least one saliva sample.
11. 11. The system of claim 1, wherein the executed instructions further cause the one or more processors to correlate at least one analyte of at least one saliva sample with at least one gene attribute.
12. 12. The system of claim 1, wherein the executed instructions further cause the one or more processors to store the health profile.
13. 13. The system of claim 1, wherein the executed instructions further cause the one or more processors to provide health monitoring updates and/or alerts to at least one access device.
14. 14. The system of claim 1, wherein the saliva sampling device is one of a plurality of saliva sampling devices, and wherein the health profile is updated and maintained based on a plurality of associated health attributes derived from a plurality of saliva samples collected by the plurality of saliva sampling devices.
15. 15. The system of claim 1, wherein the saliva sampling device comprises at least one biosensor.
16. 16. The system of claim 1, wherein the saliva sampling device comprises at least one communication device configured to wirelessly connect with a network and/or a network access device, wherein the saliva sampling device wirelessly transmits data to the one or more processors, the data being indicative of or not indicative of the at least one analyte.
17. 17. The system of claim 1, wherein the user operation comprises a user removing a cover of a storage access location on the saliva sampling device, and wherein the storage access location comprises an opening of a portion of the saliva sampling device.
18. 18. The system of claim 1, wherein the saliva sampling device comprises a plurality of saliva storage portions configured to store the at least one saliva sample for a plurality of days, and each of the plurality of saliva storage portions is configured to be enabled by a user operation, the user operation comprising removing a cover of a storage access location on the saliva sampling device.

Description

Saliva collection and testing system Cross Reference to Related Applications The present application claims the benefit of U.S. provisional application No. 62/932,396, filed on 7 at 11.2019, which is incorporated herein by reference. Background For example, in the field of proteomics, recent and continuing advances have led to the discovery of new fluid-borne biomarkers for the prediction and diagnosis of various diseases. Blood is a traditional fluid for many pathological biomarker tests. However, blood samples can be difficult to process, especially when attempting to isolate an analyte of interest (e.g., a particular protein). Due to the filtration and separation steps in the process, a relatively large number of blood samples are typically required. Furthermore, many patients are reluctant to collect blood samples due to the negative reactions associated with needle sticks. Other body fluids, such as urine and saliva, may also include biomarkers. In particular saliva has been the subject of many research fronts with the aim of identifying new biomarkers. Notably, a publication reports that 2290 different proteins in saliva have been compiled, with nearly 40% of the proteins being considered biomarkers for diseases such as cancer, cardiovascular disease and stroke, which can be found in saliva. See Loo et al."Comparative human salivary and plasma proteomes."Journal of dental research vol.89,10(2010):1016-23. Providing a saliva sample is a relatively simple procedure, i.e. spitting into a tube or wiping the mouth. Since no needle is required to provide the sample, most patients will not have the same negative reaction when providing saliva samples as when providing blood samples. In many cases, the patient may provide saliva samples outside of the point of care. For example, publicly accessible genetic testing companies (e.g., 23andme TM) use saliva to conduct genetic testing by providing customers with mailable spitting tubes. For some saliva-borne analytes, saliva is considered a "real-time" fluid, as opposed to blood circulating in a closed system, due to the manner in which saliva is continually produced, which represents the health condition .Al Muhtaseb"Serum and saliva protein levels in females with breast cancer."Oncology Letters 8.6(2014):2752-2756. at the time of collection and thus, a particular saliva sample may not provide a high degree of confidence in overall health due to the time at which the sample is collected. However, regular spitting into collection tubes or collection of oral swabs can be invasive and can present compliance problems to the patient. It would therefore be useful to have a method that could sample saliva on an extended basis with little interaction required by the patient. Disclosure of Invention Embodiments of systems, methods, and devices for tracking patient health using saliva sampling devices are disclosed that can sample saliva over an extended period of time. Some embodiments relate to a method wherein at least one analyte of at least one saliva sample may be associated with at least one health attribute. Saliva may be collected from a saliva sampling device configured to be worn by a patient's mouth. The health profile of the patient may be updated based on the at least one health attribute. Some embodiments relate to a system that may include a saliva analysis engine, which may be configured to correlate at least one analyte of at least one saliva sample with at least one health attribute. In some embodiments, saliva may be collected from a saliva sampling device configured to be worn by a patient's mouth. In some embodiments, the health monitoring engine may be configured to update the health profile of the patient based on at least one health attribute received from the saliva analysis engine. In some implementations, the health profile may include at least one profile of at least one health condition, and the at least one health attribute may be used to update the at least one status profile. In some embodiments, the health profile may include at least one risk profile for at least one disease, and the at least one associated attribute may be used to update the at least one risk profile. In some embodiments, the health profile may include at least one nutritional profile of the at least one nutritional aspect, and the at least one health attribute may be used to update the at least one nutritional profile. In some embodiments, at least one saliva sample may be collected by the saliva sampling device during an extended period of patient wear of the saliva sampling device. In some embodiments, during the incremental wear of the saliva sampling device by the patient, at least one saliva sample may be collected by the saliva sampling device over a plurality of days. In some embodiments, each of the incremental wear periods may be at least one hour. In some embodiments, the at least one saliva sample may be one of a plurality of saliva samples collected by the s