Patent Application
20220160489
The present disclosure is directed generally to oral hygiene devices and associated systems and methods of use.
Dysphagia is the condition whereby a patient has difficulty in swallowing or is unable to swallow safely. Dysphagia may be caused, for example, by stroke, neurodegenerative diseases, brain tumors or in some cases by other co-morbidities, such as respiratory disorders. It has been reported that between 7 and 10% of all adults older than 50 years of age present with clinically significant dysphagia. Of those over the age of 60, this increases to 14%. In total, 10 million Americans are evaluated each year in clinics and hospitals for swallowing difficulties. It has also been reported that over 51% of institutionalized elderly patients present with oropharyngeal dysphagia.
Patients with dysphagia have poor oral and nasal hygiene combined with ineffective clearance of pooled secretions from the area around the entrance to the airways. This can result in these secretions becoming contaminated with opportunistic pathogens. As patients with dysphagia often have ineffective airway protection, pathogenic secretions can enter the lower airways where they act as a locus for infection. Aspiration pneumonia is the main and most serious consequence of dysphagia. Oral hygiene is very hard to maintain in these patients, as many traditional oral hygiene procedures present an aspiration risk for patients with dysphagia. Consequently, gum disease and poor dental status are often seen, particularly with elderly stroke patients. This can result in the proliferation of opportunistic pathogens that migrate to the airways and act as a locus for infection. Other patients with dysphagia can present with ‘dry mouth’ due to reduced saliva production and this can also have an impact on oral health.
In view of the above, there remains a need for improved oral hygiene devices, systems, and methods.
The present technology relates to oral hygiene devices and associated systems and methods. In particular embodiments, the present technology comprises an oral hygiene device for cleaning an oral cavity of a patient. The device can be configured to dislodge a substance from an oral tissue of the patient, remove a substance from the patient's oral cavity, deliver a therapeutic agent to the patient's oral cavity, and/or stimulate the patient's oral tissues, for example. The subject technology is illustrated, for example, according to various aspects described below, including with reference to
1. A device for cleaning an oral cavity of a human patient, the device comprising:
2. The device of Clause 1, wherein the vacuum source is integrated with the base such that the vacuum source and base comprise a self-contained unit.
3. The device of Clause 1, wherein the vacuum source is an external vacuum pump.
4. The device of any one of Clauses 1 to 3, wherein the massaging region comprises at least one of ridges, valleys, bumps, or bristles.
5. The device of any one of Clauses 1 to 4, wherein the base comprises a receptacle configured to be fluidly coupled to the second lumen and collect the substance drawn from the patient's oral cavity by the vacuum source.
6. The device of Clause 5, wherein the receptacle is releasably coupled to the base such that the receptacle is disposable.
7. The device of any one of Clauses 1 to 6, wherein the reservoir is integrated with the base such that the reservoir and the base comprise a self-contained unit.
8. The device of any one of Clauses 1 to 7, wherein the pressure source is integrated with the base such that the pressure source and the base comprise a self-contained unit.
9. The device of any one of Clauses 1 to 8, wherein the shaft is disposable and the base is reusable.
10. The device of any one of Clauses 1 to 9, wherein the fluid contained within the reservoir comprises a therapeutic agent configured to prevent or inhibit colonization of the oral cavity by a pathogen and/or alleviate symptoms of dry mouth.
11. The device of any one of Clauses 1 to 10, wherein:
12. The device of Clause 11, wherein the first apertures are spaced apart along the sidewall.
13. The device of any one of Clauses 1 to 12, wherein the second aperture is disposed at a distal terminus of the device.
14. A system configured to clean an oral cavity of a human patient, the system comprising:
15. The system of Clause 14, wherein the vacuum source is configured to draw the substance from the second compartment to the vacuum source.
16. The system of Clause 14 or Clause 15, wherein the second compartment is configured to capture particulate in the substance.
17. The system of any one of Clauses 14 to 16, wherein the pressure source is a manual pump.
18. The system of any one of Clauses 14 to 17, wherein the base comprises one or more actuators configured to activate the pressure source and/or the vacuum source.
19. The system of any one of Clauses 14 to 18, wherein the base comprises a vibration motor configured to vibrate the shaft of the oral hygiene device.
20. A method of cleaning an oral cavity of a human patient, the method comprising:
21. The method of Clause 20, further comprising generating a negative pressure within the first lumen of the device to pull the fluid from the patient's oral cavity through the device to the waste container after delivering the fluid to the patient's oral cavity.
22. The method of Clause 20 or Clause 21, wherein pulling the substance from the patient's oral cavity through the device to the waste container comprises pulling the substance into an opening in the head of the oral hygiene device.
23. The method of any one of Clauses 20 to 22, wherein delivering the fluid carrying the therapeutic agent to the patient's oral cavity comprises pushing the fluid through two or more openings in the head of the oral hygiene device.
24. The method of any one of Clauses 20 to 23, wherein the fluid carrying the therapeutic agent is delivered to the patient's oral cavity as a mist.
25. The method of any one of Clauses 20 to 24, wherein generating the negative pressure and/or generating the positive pressure comprises actuating one or more actuators on a base of the oral hygiene device.
Many aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale. Instead, emphasis is placed on illustrating clearly the principles of the present disclosure.
Patients with dysphagia often have poor oral hygiene and ineffective clearance of secretions, which can contribute to the development of serious complications such as aspiration pneumonia. As many patients with dysphagia cannot manage their own oral hygiene, caregivers and healthcare providers are often tasked with caring for a dysphagic patient's oral hygiene. However, patients with dysphagia present unique challenges with regards to oral hygiene care. Such patients may have delicate oral tissues and the normal microbial flora of the patient's oral cavity is often replaced by opportunistic pathogens. Accordingly, caregivers and healthcare providers must be careful to avoid damaging the patient's oral tissues during oral hygiene care, as damaging the oral tissues can create a portal for a pathogen to enter the patient's blood stream and cause serious systemic infection. Preferably, the caregiver or healthcare provider would administer an antimicrobial agent to the patient to prevent or inhibit colonization of the patient's oral cavity by pathogens. Typically, such an agent would be administered as a mouthwash; however, mouthwash presents an aspiration risk for dysphagic patients and cannot be used. Moreover, pooled secretions and residual fluid from oral hygiene are also aspiration risks for dysphagic patients.
To address the foregoing challenges, the devices and systems disclosed herein are configured to gently dislodge substances within a patient's oral cavity, remove substances (e.g., pooled secretions, food debris, plaque, etc.) from the patient's oral cavity, and/or deliver a therapeutic agent to the patient's oral cavity. The devices and systems disclosed herein may also be configured to stimulate an oral tissue of the patient (e.g., the patient's gingiva) to promote health of the oral tissue. In some embodiments, the device comprises a shaft and a base configured to be releasably coupled to one another. The shaft can be disposable to prevent cross-contamination between patients and between treatments. The base can either be disposable or reusable. For example, a base incorporating more sophisticated functionalities, such as an automated pressure source integral with the base, may be reusable. A reusable base may comprise one or more disposable components. In some embodiments, the entire base is disposable.
In particular embodiments, the shaft comprises a head with a massaging region configured to engage tissues and/or contents of the oral cavity to dislodge a substance on an oral tissue and/or stimulate an oral tissue. Various features of the massaging region (e.g., texture, stiffness, etc.) can be configured such that engaging the patient's oral tissues with the massaging region is associated with a reduced risk of causing trauma the patient's oral tissues. In some embodiments, the device is configured to deliver a fluid carrying an antimicrobial agent through a lumen of the shaft to the patient's oral cavity to prevent or inhibit colonization of the oral cavity by one or more pathogens. In some embodiments, the device is configured to aspirate a substance from the patient's oral cavity into a lumen of the shaft to remove substances that create potential aspiration risks (e.g., dislodged debris, pooled secretions, excess antimicrobial agent, etc.).
In some embodiments, the head 110 comprises a massaging region configured to engage one or more oral tissues (e.g., teeth, gingiva, tongue, palate, etc.) and/or contents of the patient's oral cavity to dislodge one or more substances disposed on an oral tissue. In some embodiments, the massaging region is configured to engage one or more oral tissues to stimulate blood flow in the one or more oral tissues. As such, the massaging region can comprise ridges, valleys, bumps, bristles, other textural features, or combinations thereof. The massaging region can have a stiffness sufficiently low such that the massaging region is configured to atruamatically engage the oral tissue. The massaging region can be a single massaging region or multiple massaging regions. In some embodiments, the multiple massaging regions each comprise the same properties and intended functions. Yet, in some embodiments each of the multiple massaging regions comprises a unique intended function and corresponding properties. For example, a first massaging region can comprise a greater stiffness such that the first massaging region is configured to apply a sufficient force to dislodge a substance from an oral tissue. A second massaging region can comprise a lower stiffness such that the second massaging region is configured to gently engage a gingival tissue of the patient to stimulate blood flow in the gingival tissue.
The head 110 can comprise a shape and a size configured to allow a user to engage various portions of the patient's oral cavity. According to some embodiments, for example as shown in
The head 110 can comprise one or more apertures configured to transport substances between the device 100 and the patient's oral cavity. In some embodiments, the head 110 comprises one or more first apertures 118 and one or more second apertures 120. For example, as shown in
According to some embodiments, the shaft 102 comprises one or more lumens extending therethrough. For example, as shown in
The shaft 102 can be configured to be releasably mechanically coupled to the base 104. For example, the projection 126 and/or at least a portion of the first portion 106 of the shaft 102 can be configured to be inserted into an opening 130 in a housing 132 of the base 104. In some embodiments, the first portion 106 of the shaft 102 includes an engagement feature 128 configured to secure the shaft 102 to the base 104. The engagement feature 128 can comprise a flange, shoulder, barb, ridge, bump, protrusion, magnet, screw, clip, or other suitable means for releasably securing the shaft 102 and base 104 to one another. According to some embodiments, for example as shown in
The first and second lumens 122, 124 of the shaft 102 can be fluidly coupled to the base 104 of the device 100. The base 104 can contain and/or be configured to be coupled to one or more pressure sources and/or a fluid source to transport a substance between the device 100 and the patient's oral cavity via the first and second lumens 122, 124 of the shaft 102. In some embodiments, the base 104 includes a vibration source configured to vibrate the shaft 102 of the device 100. Vibration of the shaft 102 may facilitate dislodging a substance from the patient's oral tissues and/or stimulating the patient's oral tissues. In some embodiments, the base 104 comprises an actuator 134 configured to actuate the one or more pressure sources and/or the vibration source. The actuator 134 can comprise a button, a switch, a slider, etc. In some embodiments, the base 104 comprises a connector 136 configured to mechanically and/or electrically connect an external device (e.g., a pressure source, a power source, etc.) to the base.
According to some embodiments, for example as shown in
The first compartment 138 can be fluidly coupled to a first pressure source. In some embodiments, the first pressure source is contained within the base 104 of the device 100. In some embodiments, the first pressure source is an external pressure source and the base 104 is configured to be coupled to the first pressure source (e.g., via connector 136). The first pressure source can be a manual pressure source or an automatic pressure source. The first pressure source can be configured to generate a positive pressure within the first compartment 138 and/or the first lumen 122 of the shaft 102 to deliver at least some of the fluid in the first compartment 138 through the first lumen 122 and the first apertures 118 to the patient's oral cavity. The fluid can be delivered to the patient's oral cavity as a mist or as a continuous stream of fluid. In some embodiments, the fluid is delivered such that the fluid coats the surfaces of the patient's oral cavity. For example, the first apertures 118 of the head of the shaft 102 can be spaced apart such that the fluid is pushed out of the first apertures 118 along multiple directions.
Referring still to
The second compartment 140 can be fluidly coupled to a second pressure source. In some embodiments, the second pressure source is contained within the base 104 of the device 100. In some embodiments, the second pressure source is an external pressure source and the base 104 is configured to be coupled to the second pressure source (e.g., via connector 136). The second pressure source can be a manual pressure source or an automatic pressure source. The second pressure source can be configured to generate a negative pressure (i.e., suction) within the second compartment 140 and/or the second lumen 124 of the shaft 102 to pull a substance from the patient's oral cavity into the second lumen 124. In some embodiments the second pressure source is configured to pull the substance from the second lumen 124 into the second compartment 140. As previously described, in some embodiments the second compartment 140 is configured to retain the substance. Additionally or alternatively, the second pressure source can be configured to pull the substance through the second compartment 140 and out of the device 100 (e.g., to an external container, to the second pressure source, etc.).
The first pressure source and the second pressure source can be separate devices or the same device. The pressure source(s) can include, for example, a power source and a controller including a processor coupled to a memory that stores instructions (e.g., in the form of software, code or program instructions executable by the processor or controller) for causing the power source to generate pressure within device according to certain parameters provided by the software, code, etc.
Although many of the embodiments are described above with respect to devices, systems, and methods for cleaning an oral cavity of a patient with dysphagia, the technology is applicable to other applications and/or other approaches. Moreover, other embodiments in addition to those described herein are within the scope of the technology. Additionally, several other embodiments of the technology can have different configurations, components, or procedures than those described herein. A person of ordinary skill in the art, therefore, will accordingly understand that the technology can have other embodiments with additional elements, or the technology can have other embodiments without several of the features shown and described above.
The descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. For example, while steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.
Moreover, unless the word “or” is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of “or” in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.
As used herein, the terms “generally,” “substantially,” “about,” and similar terms are used as terms of approximation and not as terms of degree, and are intended to account for the inherent variations in measured or calculated values that would be recognized by those of ordinary skill in the art.
The present application claims the benefit of priority to U.S. Provisional Patent Application No. 63/198,909, titled ORAL HYGIENE DEVICES, SYSTEMS, AND METHODS, filed Nov. 20, 2020, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63198909 | Nov 2020 | US |
