Personal medical device for administering treatment via mucous membrane

Abstract

The current pandemic due to Covid-19 stresses the importance of effectively treating highly contagious and deadly infections. The described medical device is meant to help the medical community by enabling them to treat patients more effectively. The delivery mechanism focuses on the mucous membrane. It is noninvasive and easy to use by patients directly. The device is hand-held, with incorporated germicidal UVC lights. It has two chambers connected by an internal application tip. The tip connects to a removable container which can be used with the prescribed treatment/therapy, vaccine, or viral testing fluid/reagent, as needed. Due to its versatility, non-invasive nature and germicidal properties, this device supports rapid response to infectious diseases, such as COVID-19. It may also further promote the development and use of different inoculation and drug techniques and delivery systems by enabling easy administration, via the mucous membrane.

Claims

1. A medical device, comprising: a cylindrical frame having two internal connected chambers; embedded LED UVC lights (222-254 nm) within the outer perimeter walls of said frame; UVC blocking technology along said outer perimeter; a timer plus electromagnetic fail-safe locking mechanism attached to said frame; contact closure light switch embedded into the lids of said frame; an energy source input permanently attached to said frame; an inner tip attached to said frame; a tracking code attached to said frame; a container removably secured to said inner tip of said frame.

2. A medical device as in claim 1, wherein said frame is made from medical grade inert material, which does not degrade in response to environmental factors or due to UVC light.

3. A medical device as in claim 1, wherein each of the said device lids are attached to said medical device via a spring loaded hinge.

4. A medical device as in claim 1, wherein each lid has an embedded magnet which connect to a complimentary embedded metal piece on the device body.

5. A medical device as in claim 1, wherein said removable container and its lid is manufactured from medical grade inert material which does not degrade in response to environmental factors or due to UVC light.

6. A medical device as in claim 1, wherein said removable container may be UVC blocking or UVC transparent as needed, depending on intended use.

7. A medical device as in claim 1, wherein said energy source may be powered by batteries, a USB cable charger, a solar energy charger or solar rechargeable battery.

8. A method of using the medical device comprising: filling a removable container with prescribed treatment; shipping said container to treatment site; attaching said container to the medical device with the tip pointed upwards; enabling the UVC germicidal function to insure safety before use; flipping the container so the fluid moves into the tip; opening the lid with the tip and fitting the opening to the patient to create a shield between the patient and the environment; tilting the head to allow the treatment to come into contact with the mucous membrane and be absorbed into the body; closing the lid of the device to enable the sanitization cycle after use.

9. The method of claim 8, wherein said prescribed treatment further comprises vaccine, immunoglobulins, convalescent plasma, monoclonal antibodies, antiviral drugs or any approved medical treatment which can be administered via the mucous membrane.

10. A method of using the medical device, comprising: filling a removable container with testing solution; applying the patient sample to said container and replacing lid; placing the container with lid attached into the chamber; running an UVC light cycle to sanitize device; conducting testing of said container to obtain diagnosis; dispensing another removable container with prescribed treatment to administer to patient.

11. The method of claim 10, wherein said testing solution is further comprised of rapid testing reagent or medium which can be done on site or testing which must be shipped to a lab offsite.

12. A method of using the medical device, comprising: shipping/giving removable container to patient(s) as part of a vaccine/inoculation kit; removing lid, applying sample of viral antigen to said container and then replacing lid; running a UVC cycle to insure disinfection of device and removable container; filling removable container with vaccine adjuvant solution from vaccine/inoculation kit; attaching sample container with inactivated viral antigen plus adjuvant to device; fitting the medical device to the patient to create a shield between the patient and the environment; tiling the head backwards and allowing the solution to come into contact with the mucous membrane and inhaling to induce antibody response; closing the lid of the device to enable sanitization cycle after use; performing antibody testing to insure adequate antibody response.

13. A method of claim 12, wherein said antigen is further comprised of either a viral sample collected on site, or a viral protein isolate obtained offsite and shipped to the patient.

14. A method of claim 13, wherein said removable container is further comprised of inert medical grade UVC transparent material.

15. A method of claims 8 and 10, wherein said disinfection/germicidal function may be done via a timed UVC light cycle or sanitizer solution in the event of a power source failure.

16. A method of claim 12, wherein said UVC light cycle is applied at the appropriate intensity and time interval to insure sanitization/germicidal effect of the removable container contents, as well as the entire chambers of the device.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING

[0030] FIG. 1: Medical device with removable container prior to insertion into the device

Feature:

[0031] 1—thread mechanism connecting the 2 parts of the device [0032] 2—spring hinge [0033] 3—opening curve for top lid [0034] 4—opening curve for bottom lid [0035] 5—LED UVC lights around perimeter (number and placement of lights must insure entire area of device is sanitized by at least 222 nm for both chambers) [0036] 6—magnetic area top lid [0037] 7—metal ring top lid [0038] 8—magnetic area bottom lid [0039] 9—metal ring bottom lid [0040] 10—cone tip for delivery of treatment [0041] 11—UV blocking wall [0042] 12—UVC permeable wall

[0043] FIG. 2: Example of UV blocking removable container with lid depicted separately from medical device

Feature:

[0044] 1—UV blocking technology [0045] 2—UV blocking lid which threads on [0046] 3—inner curve to facilitate liquid movement towards opening [0047] 4—thread mechanism

DETAILED DESCRIPTION OF THE INVENTION

[0048] This medical device is completely enclosed and composed of a top container chamber and a bottom dispensing chamber with inner application cylindrical tip. Both lids are secured to the rest of the device via embedded magnets and spring hinges to insure a secure fit, and the walls of the device include LED UVC lights along the perimeter to insure the inner area is fully covered by germicidal UVC light. All parts and components of the device are made from medical grade inert materials which do not react or degrade during use, such as: quartz, graphene, silicon/other polymers, metals (i.e. Titanium) or other composites and alloys, available on the market and certified for safe use under the described conditions.

[0049] The UVC lights are LED UVC lights due to their safety and energy efficiency. Wherever the device is expected to withstand extreme stress a layer of transparent graphene can be used to reduce risk of breakage for the lights. The UVC range is 222 nm-254 nm, to insure germicidal efficacy. As an additional precaution the device is designed so that the user/patient is never exposed to the UVC light, by insuring that the circuit to turn the lights on can only be completed when the lids are in the closed position. The efficacy of UVC germicidal properties on hard surfaces and for water (fluid) samples have been well documented and are already in use for functions such as UVC air and water sanitization systems. The closed system of this medical device insures that full sanitization can be achieved for each method of use, while preventing the UVC light from reaching the patient.

[0050] FIG. 1, attached, shows the overall design of the device and the treatment container. FIG. 2 depicts the treatment container independently of the device with its own lid; this depicts the UV blocking technology of the removable container. For any situation where the inner product does not need to be UVC protected, a simpler model can be used, with a UVC transparent wall, instead of UVC blocking. As depicted, the device contains 2 main parts: a removable container and a delivery system which can be sterilized by disinfecting LED UVC light (FIG. 1, feature 5 and FIG. 2, feature 1). This device can deliver the medical treatments to the patients respiratory pathway.

1. Removable Container and Top Chamber

[0051] Devices has a top chamber which is equipped with a removable container which is used to deliver the treatments prescribed (I.e. convalescent plasma, vaccine, other applicable respiratory pathway medical treatments, etc). The lid has a simple spring hinge and embedded magnet which secures the lid to the rest of the device body.

[0052] The removable container has several design options:

[0053] The first option, is made of medical grade inert material with intrinsic UV blocking properties, or added ones, such as UV blocking film or dye (FIG. 2, feature1)—it is isolated in order to protect the solution from any damaging environmental effects. It has a basic UV blocking (FIG. 2, feature 2) medical grade inert lid which can be easily removed as needed (twists to remove).

[0054] The second option is that this removable container is UVC permeable. This can be made from quartz, transparent graphene or other specialized UVC permeable material. This style can be useful when additional disinfection of the contents is necessary. The effects of UVC as an additional disinfection step can be used to insure hygiene of blood based products, such as plasma, without risk of damage to the necessary proteins, while safely inactivating antigens. This is a very critical quality assurance step to insure efficacy of the product.

[0055] The inside is curved in order to facilitate the liquid movement (FIG. 2, feature 3). It attaches to the rest of the device via a simple thread mechanism (FIG. 1, feature 1). The containers for the treatment are replaceable and/or disposable as needed. For example, they can be filled out by vaccine manufacturers and then sent out to patients. The shape of the container in FIG. 2, is stadium to insure easy grip and penetration of UVC light. Other shapes may also be used, such as a basic cylindrical shape.

2. Bottom Chamber for Delivery of Treatment

[0056] The bottom chamber contains a cylindrical outer shell made of medical grade inert material. The material depends on intended purposes, as described in the prior section. This encompasses the entire device, and secures the medical treatment container in place (FIG. 1). The bottom lid, similar to the top lid, also has a spring hinge and magnetic lid which allow it to snap into place, as described in the section “opening and closing details” below.

[0057] The bottom chamber delivers the treatment to the patients respiratory tract. It has UVC lights to sterilize the device along the outer circumference (FIG. 1, feature 5). The UVC light is filtered via UV blocking technology (i.e. dye, film or paint) and does not reach the user of the device.

[0058] Device has an inner cone tip via which treatment is delivered. The cone tip (FIG. 1, feature 10) is part of the overall structure; same one piece, not an attachment. The conical tip has a simple but comfortable design with rounded edges which can deliver the medical treatment to be inhaled via the nasal airways straight into the lungs. Since the device purposefully contains no pressure system, the patient has to inhale for best use creating a negative pressure environment. An additional step is to tilt the head backwards and allow the fluid to drift down via gravity. When not in use the device can simply be stored.

[0059] The outer shell creates a barrier between the patient and the environment when the device is fitted over the patients face limiting airflow and shielding the patient. After use, the device snaps shut and is sterilized and the patient can put their mask back on if they are not in isolation.

[0060] The outer shell enclosed all parts of the device which come into contact with the patient. The purpose of the chamber is to sanitize the device automatically after each use in order to insure the sterilization of the device and prevent spread of the virus.

Opening and Closing Details

[0061] The cylindrical outer shell has a slanted and curved opening design for the top and bottom lids so as to enable ease of use (FIG. 1, feature 3,4). This allows the treatment container to be easily accessed at the top of the device. It also allows the bottom of the device, which contains the tip, to naturally fit the curved shape of the face. The lids are a complimentary fit for this shape and connected via a spring hinge (FIG. 1, feature 2). Each lid also includes a metal ring (FIG. 1, feature 7,9) imbedded in the walls and a complimentary magnetic strip (FIG. 1, feature 6,8) to connect the lid to the rest on the device. The lid can easily be snapped shut and clicks into place. The user has to hold the lid open or it springs shut.

UVC Lights Operation Details

[0062] The LED UVC lights (222 nm-254 nm) are built into the side walls of the device to insure every part of the device which comes into contact with the patient can be sanitized. LEDs were chosen specifically due to their efficiency. The wall behind the lights is UV blocking (FIG. 1, feature 11) and the wall in front of the lights allows UVC light to pass through (FIG. 1, feature 12). In the case of a metal body for the device, the frontal wall is made out of a different, UVC permeable medical grade material.

[0063] Once the lid is closed the UVC lights turn on and remain on for a set time period. The UVC lights are guided via a contact closure timed light switch mechanism, linked to an electromagnetic fail-safe lock. The circuit is timed to insure a complete UVC cycle is run each time. Once it is completed the electrical current stops and the device reopens. This is required to ensure that the necessary time frame for UVC disinfection is fulfilled, and the device takes full advantage of the germicidal properties of UVC light. The UVC LED lights are selected for the appropriate germicidal wavelength, of at least 222 nm, up to 254 nm, since these wavelengths were shown to have effective germicidal properties. The mechanism turns “on” when the both lids are closed, and “off” when open. The entire perimeter of the device is protected with UV blocking technology. (The sanitizer method may also be used by simply sanitizing the device via liquid sanitizer, as a fail safe.) The device can be powered by batteries or plug in. The batteries can be regular or rechargeable. The device can also be powered by rechargeable solar batteries directly or plugged into a separate solar charger.

Overall Fit—Top and Bottom Chambers

[0064] When both top and bottom parts of the device are fitted together they sit flush to each other. This is done via a thread mechanism (FIG. 1, feature 1). The top threads into the bottom. The threads are at the opening of the top container and right before it connects with the tip on the bottom container.

[0065] Device is portable, handheld, and can be given directly to patients and taken home with them; it can be used while the patient is in isolation/quarantine. It can be easily shipped and distributed in viral hotspots. It is ideally suited to integrate the use of multiple viral treatment options.

“Smart” Integration Options

[0066] 1. Users can manually track results and simply upload to contact tracing apps. [0067] 2. Each device can be equipped with a scan code. Users can then scan their device and upload the data to a encrypted cloud based system, thus protecting user privacy while enabling contact tracing and rapid response. The individual can then request further assistance or treatment as needed.

Manufacturing

[0068] The device can be manufactured easily via standard techniques by any company with access to the materials needed. The main body of the device lends itself well to 3D printing techniques. The simple circuit and locking mechanism can either be made in house or purchased. The LED UVC lights can either be made or purchased from eligible manufacturers.

Material Examples

[0069] UVC transparent: quartz, transparent graphene, or other materials, composites, alloys or polymers with these properties.

[0070] UVC blocking: glass, plastic, acrylic, silicon, Titanium, or other medical grade composites, alloys or polymers with these properties, or UVC blocking film or dye in combination with UVC permeable medical grade materials.

[0071] In most cases, simple medical grade polymers would suffice for the body of the device, with the components which need to be UVC transparent being made from materials like quartz, or any other UVC transparent material.

[0072] In cases where the target demographic is first responders, law enforcement or military personnel and the device must maintain functionality under extreme conditions, inert medical grade metals, such as medical grade Titanium, alloys, or graphene may also be used. Graphene can be used as both a metal and a thin layer of transparent graphene which is UVC permeable. Thus it is appropriate for the body of the device as well as the LED UVC lights and the UVC permeable inner container. Graphene coatings are known to increase the strength of steel, thus it can be used to increase the impact resistance of UVC permeable materials like quartz or on its own. Titanium is an excellent choice as well due to its wide availability, light weight and extremely strong structure. Unlike other metals it does not corrode in the presence of water. Both materials are an excellent choice for anyone who may need to use it under extreme conditions, although this is not intended to be a exhaustive list and other options do exist and may be used. The material variations of the device does not significantly alter its manufacturing or use.

Uses of the Medical Device

[0073] For dispensing treatments, the medical clinic or manufacturing company can simply fill the treatment container(s) and send them back to the patient. It has been well documented in the art that early administration of treatments can lead to the best results for the patient, and help avoid hospitalization. Thus, timing is of paramount importance. This device allows a safe, decentralized approach to this type of therapy which can help patients prior to hospitalization with severe symptoms, who do not have access to vaccine. The disposable container can be inserted into the device and the treatment is able to be used as liquid drops, as prescribed. The UVC light function insures sanitization and safety during use. The same principles apply for administration of any applicable drug treatments. This can also be used for boosters of vaccines to maintain strong immunity or to address variants.

[0074] An additional simple use for this medical device would be sample collection. The removable container can be used by the patient to collect the samples required. The container can then be recapped and sanitized. It can subsequently be used with testing reagents/strips at home, or shipped to the lab. Techniques which may still require lab processing can still be used, but the samples can be sent directly to the lab by the patients themselves, thus avoiding lineups at testing sites. For rapid tests which can be done at home, patients can share the results with their doctor right away and upload to COVID tracking apps. This will cut down on testing wait times and can be done repetitively as needed. Once the patient discovers that they have tested positively they can seek treatment right away.

[0075] Furthermore, it is also possible to use the removable container for future vaccine development. This could be essential in responding to new outbreaks as soon as possible. It may prove useful for first responders or military members when they are required to go into an infected area by enabling the group to immunize themselves as soon as possible, rather than wait for the infection to run its course through the entire group, as we saw in spring of 2020. This can be done by collecting viral samples in an UVC transparent container, and inactivating the virus right away via the UVC light function. In essence this opens up the possibility to develop “vaccine kits”, which can be activated as needed if an outbreak happens. This can be done by adding the isolated spike protein isolates to a vaccine adjuvant.sup.1 (in case those isolated spike proteins are known and available), or using the UVC light to inactivate a viral sample obtained on site, and using those sample to create a vaccine faster. The ability to generate an immune response by using the fragments of the virus or inactivated virus has been well established in the art.sup.1,2. This method or virus inactivation is extremely fast compared to other methods and does not require extensive lab equipment or use of other viral vectors, or cold chain. Instead it opens up the possibility to use a variety of vaccine formulations (including powders) and create fast, easy to use vaccine kits. This provides an additional method of using the body's own defence system to generate that response with minimal intervention. Confirmation that the virus has been inactivated can be obtained and shared immediately since UVC light works within minutes. This can then be added to a vaccine adjuvant which is already part of the vaccine kit. Testing can be used afterwards, to check the antigen level and again for the antibody response. These steps can all be accomplished safely while quarantine protocol is being observed. In the aforementioned examples, such as the cruise ships, the military marine ships, or any similar situation, it can make a considerable impact and save lives, by enabling those infected are able to get results right away and respond with a fast treatment. Thus they can induce immunity to the virus in at-risk personnel right away; as opposed to waiting to waiting weeks or months for new vaccine developments or simply waiting for the infection to run its course through the entire isolated population. This provides a quick alternative and fills the gap in patient care. It provides an active way of fighting the virus while in isolation without the need to wait or really on equipment which is simply out of reach.

SUMMARY

[0076] Other treatment delivery systems currently available simply do not have the ability to enable a fast response to the pandemic. This is evidenced by the bottlenecks in supplies, testing/treatment lineups, and overcrowding of hospitals. They are required to be used in hospital setting and/or by a health care professional. This makes it difficult for patients to access care right away and increase the likelihood of serious illness. The high transmission rate of highly contagious viruses and need to quarantine makes it extremely risky for individuals to access in-person medical care. In addition the need for doctors to be physically present to administer every step of the treatment creates bottle necks in medical care, overwhelms hospitals and causes delays in other critical care areas. Syringes pose the risk of infection and pain and must be administered by a medical professional. Spray and aerosol delivery systems cannot be used without the risk of spreading the infection. They also cannot be sterilized effectively after use and must be disposed of immediately. None of these methods enable fast response in a viral pandemic and easy tracking of results. They all present a clear risk to healthcare professionals, as well as patients/public.

[0077] By comparison, this personal use device enables remote care and pandemic infection tracking, is versatile in terms of which treatments it can dispense, and can be easily sterilized after each use. It is easily manufactured from a variety of materials and portable. It allows patient to have confidence that the treatment they receive is safe to use due to the extra sanitization and can be easily applied. In addition it provides the ability to increase testing efficiency via rapid testing methods and direct shipment of sanitized samples. Finally, it enables the development of emergency vaccine kits, which can be used right away to induce an immune response and thus prevent infection which can be especially useful for military personnel, first responders or anyone who cannot access a hospital right away. This last function is especially useful for combating new virus variants or new viruses. It was designed as an easy to use, multi-functional, self-sterilizing device, in order to enable rapid response to infections. The UVC light is used in a closed system, thus insuring the safety of the user and reliable standardized results. It does not require specialized training to use and enables shipping of treatments to patients directly, thus resolving the overcrowding of hospitals and medical centres.

REFERENCES

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