SILICONE-BASED INFLATABLE DEVICE FOR MANAGING TRISMUS IN PATIENTS AND METHOD THEREOF

Abstract

Embodiments of the present disclosure relate to a silicone-based inflatable device (100) for managing trismus in patients and a method (200) of managing trismus. The device (100) includes a silicone body (102), at least two inflatable chambers, an inflation mechanism and a medication reservoir. The silicone body (102) is configured to fit within oral cavity of a patient. The inflatable chambers (104) are embedded within the silicone body (102), designed to fit between upper and lower arches of the mouth to expand and provide controlled force for gradual mouth opening and gradual stretching of the buccal and labial mucosa. The inflation mechanism having a handle pump is operably connected to the inflatable chambers (104) to control the degree of inflation and deflation. The medication reservoir integrated into the device, is configured to dispense therapeutic agents directly into the oral cavity.

Specification

Description:TECHNICAL FIELD
[0001] The present disclosure generally relates to the field of medical devices. More particularly, the present disclosure relates to a silicone-based inflatable device for managing trismus in patients and a method of managing trismus.

BACKGROUND
[0002] Trismus, characterized by the inability to fully open the mouth, has been a significant challenge in oral and maxillofacial rehabilitation, particularly among patients recovering from head and neck cancer treatments and other surgical interventions. Current technologies used for managing trismus primarily include mechanical devices, rigid splints, and passive stretching exercises.
[0003] TheraBite™ Jaw Motion Rehabilitation System utilizes a mechanical apparatus that patients manipulate to stretch their jaw. While effective in promoting mobility, it often causes discomfort and pain during use, leading to poor patient compliance. Hinge Mandibular Expanders are typically made of metal and are designed to hold the jaw in a slightly open position. However, they are rigid and can exacerbate discomfort, especially for patients with sensitive oral mucosa. Tongue Depressors and Manual Stretching: While these methods are widely used, they are often inefficient and rely heavily on patient compliance. The manual nature of these techniques can also lead to inconsistent results,
[0004] Many rigid devices cause additional pain and discomfort, leading to low compliance rates among patients. Current solutions often require significant effort from patients, which can be burdensome and may not yield substantial improvements in mouth opening. Most existing devices do not incorporate medication delivery systems, limiting their ability to address associated pain and inflammation effectively.
[0005] Current trismus treatment devices, such as Therabite and Dynasplint, are made from rigid materials, causing significant discomfort and even pain during use. Patients with muscle contracture and fibrosis often experience irritation and soreness while using these devices, which limits their compliance and treatment success. Existing devices lack fine-tuned adjustability for patients at different stages of trismus severity. The one-size-fits-all approach makes it difficult for patients with severe fibrosis to use the devices effectively, as they cannot gradually stretch the jaw at a safe and comfortable pace.
[0006] None of the currently available devices incorporate any system for delivering medication directly to the affected area. This is a major limitation since pain and muscle stiffness make it harder for patients to comply with mechanical stretching exercises. The discomfort, complexity, and pain associated with current devices lead to poor patient compliance, which diminishes their efficacy. Most devices require manual operation or continuous supervision, making it difficult for patients to use them regularly without assistance.
[0007] Rigid devices and manual stretching techniques may inadvertently cause damage to already sensitive oral tissues, especially in patients with advanced trismus. The sudden application of force during treatment can worsen the condition.
[0008] To address these limitations, the present invention provides a silicone-based inflatable device for managing trismus in patients and a method of managing trismus that overcomes the shortcomings of the prior art.

OBJECTS OF THE PRESENT DISCLOSURE
[0009] It is a primary object of the present disclosure to provide a more comfortable, flexible, and user-friendly silicone-based inflatable device for patients suffering from trismus.
[0010] It is another object of the present disclosure to develop an inflatable device with the use of silicone that significantly reduces discomfort, as it molds to the contours of the patient's mouth, minimizing irritation and pain.
[0011] It is yet another object of the present disclosure to provide a device that allows for gradual inflation, promoting gentle expansion of the buccal and labial mucosa, thereby facilitating a slow increase in mouth opening, making it more tolerable for patients compared to abrupt stretching methods.
[0012] It is yet another object of the present disclosure to provide a device with integrated medication delivery feature that provides localized pain relief and muscle relaxation, addressing the underlying causes of trismus while simultaneously promoting physiotherapy.
[0013] It is yet another object of the present disclosure to provide a device that encourages consistent use, ultimately leading to better rehabilitation outcomes by focusing on comfort and gradual improvement.
[0014] It is yet another object of the present disclosure to provide a device that enhances oral hygiene practices, thereby reducing the risk of opportunistic infections that are prevalent in patients with limited mouth opening.

SUMMARY
[0015] The present disclosure generally relates to the field of medical devices. More particularly, the present disclosure relates to a silicone-based inflatable device for managing trismus in patients and a method of managing trismus.
[0016] The primary aspect of the present invention is to design a silicone-based inflatable device for managing trismus in patients. The device aims at addressing trismus, a debilitating condition characterized by restricted mouth opening due to muscle contracture and fibrosis, often resulting from head and neck cancer treatments, dental surgeries, or various medical conditions. The device is crafted from flexible silicone material, which minimizes discomfort compared to traditional metallic devices, allowing for a comfortable fit in both the upper and lower arches of the mouth. Its innovative design incorporates inflatable components strategically placed in the middle of both arches, enabling the gradual expansion of the buccal and labial mucosa, thereby facilitating mouth opening through a user-friendly inflation mechanism similar to a BP cuff.
[0017] In an aspect, a method of managing trismus in patients using a silicone-based inflatable device is disclosed. The method includes inserting the device into a mouth of a patient and positioning at least two inflatable chambers against upper and lower arches. The chambers are gradually inflated via a handle pump by the patient, thereby allowing for precise control of inflation level, enabling the patient to increase the distance of the mouth opening incrementally based on their comfort level. Medications such as localized pain relief or muscle relaxants are directly dispensed into oral cavity through a medication reservoir using a pre-filled syringe or a medication dispenser by a patient. The method further includes deflating the chambers via the handle pump by the patient using a one-way valve allowing for controlled deflation, ensuring that the device is easily removed without sudden changes in pressure. The device is designed to stretch and rehabilitate the affected muscles of the patient gradually and safely.

BRIEF DESCRIPTION OF DRAWINGS
[0018] The accompanying drawings are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure, and together with the description, serve to explain the principles of the present disclosure.
[0019] FIG. 1 illustrates an exemplary schematic diagram of the silicone-based inflatable device for managing trismus in patients, in accordance with an embodiment of the present disclosure.
[0020] FIG. 2 illustrates an exemplary flowchart explaining the method of managing trismus in patients using a silicone-based inflatable device, in accordance with an embodiment of the present disclosure.

DETAILED DESCRIPTION
[0021] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit, and scope of the present disclosure as defined by the appended claims.
[0022] Specific details are given in the following description to provide a thorough understanding of the embodiments. However, it will be understood by one of ordinary skill in the art that the embodiments may be practiced without these specific details. For example, circuits, systems, networks, processes, and other components may be shown as components in block diagram form in order not to obscure the embodiments in unnecessary detail. In other instances, well-known circuits, processes, algorithms, structures, and techniques may be shown without unnecessary detail to avoid obscuring the embodiments.
[0023] Also, it is noted that individual embodiments may be described as a process that is depicted as a flowchart, a flow diagram, a data flow diagram, a structure diagram, or a block diagram. Although a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel or concurrently. In addition, the order of the operations may be re-arranged. A process is terminated when its operations are completed but could have additional steps not included in a figure. A process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc. When a process corresponds to a function, its termination can correspond to a return of the function to the calling function or the main function.
[0024] The present disclosure generally relates to the field of medical devices. More particularly, the present disclosure relates to a silicone-based inflatable device for managing trismus in patients and a method of managing trismus.
[0025] Trismus presents significant challenges for patients, such as difficulties in maintaining oral hygiene, chewing, speaking, and swallowing, all of which detrimentally impact their quality of life. This device not only assists in the treatment and rehabilitation of trismus but also integrates a medication delivery system that allows for localized pain relief and muscle relaxation directly within the oral cavity.
[0026] The gradual inflation of the device promotes a slow and safe increase in mouth opening, while the provision of medicinal support helps alleviate pain associated with muscle tightening due to contracture and fibrosis. Upon regular use, patients can expect noticeable improvements in their ability to open their mouths, ultimately enhancing their capacity to perform daily activities comfortably.
[0027] By improving oral hygiene, reducing the risk of opportunistic infections, and enhancing overall functionality, this innovative device represents a significant advancement in the management of trismus. It empowers patients to regain normalcy in their daily lives, significantly contributing to their overall well-being and recovery, thus filling a crucial gap in current therapeutic options for individuals affected by this challenging condition.
[0028] FIG. 1 illustrates an exemplary schematic diagram of the silicone-based inflatable device (100) for managing trismus in patients, in accordance with an embodiment of the present disclosure.
[0029] With reference to FIG. 1, the device (100) includes a silicone body (102, 110), at least two inflatable chambers (104), an inflation mechanism and a medication reservoir. The silicone body (102) is configured to fit within oral cavity of a patient. The inflatable chambers (104) are embedded within the silicone body (102), designed to fit between upper and lower arches of the mouth to expand and provide controlled force for gradual mouth opening and gradual stretching of the buccal and labial mucosa. The inflation mechanism having a handle pump is operably connected to the inflatable chambers (104) to control the degree of inflation and deflation. The medication reservoir integrated into the device, is configured to dispense therapeutic agents directly into the oral cavity. The inflatable chamber (104) is made by a PCS inflatable material. The silicone body (102, 110) is an outer part made of latex-free medical grade material. The device (100) further includes an inner pipe connector (106), a silicon lining gel in the inner portion (108) and a tube hose for air-pumping silicon material (112).
[0030] In an embodiment, the inflation mechanism includes a one-way valve to ensure that air remains in the inflatable chambers until the patient decides to deflate the device, providing consistent therapeutic pressure and ensuring patient safety during use. The maximum allowable pressure of the one-way valve before venting is 25 mmHg to prevent over-inflation. The device (100) is designed with rounded edges and contoured shapes to fit comfortably against the gums and teeth, ensuring that the device (100) does not create additional pressure points that leads to pain. The silicone body is a flexible, biocompatible body constructed from medical-grade silicone, designed to minimize irritation and maximize comfort during prolonged use. The inflatable chambers are provided with compartments for gradual expansion to facilitate increased mouth opening. The device (100) is designed for accommodating various degrees of mouth opening, and ensuring long-term comfort during use.
[0031] In an embodiment, the proposed disclosure is a silicone-based inflatable device specifically designed for patients suffering from trismus-a condition that severely limits mouth opening. This device aims to provide an effective solution for managing trismus, enhancing oral hygiene, and improving the overall quality of life for affected patients. The main body of the device is made from medical-grade silicone. This material is chosen for its flexibility, biocompatibility, and comfort. The silicone is soft to the touch, minimizing irritation to the oral mucosa and ensuring a gentle fit within the mouth. The device includes inflatable lateral chambers designed to fit into the upper and lower arches of the mouth. These chambers expand and contract through controlled inflation, allowing for gradual stretching of the buccal and labial mucosa.
[0032] In an embodiment, a handle pump, similar to a BP cuff, is integrated into the design. This pump allows patients or caregivers to easily inflate and deflate the device. The inflation mechanism includes a one-way valve to ensure that air remains in the chambers until the patient decides to deflate the device. An internal channel runs through the device to deliver medications directly into the oral cavity. This channel can be connected to pre-filled syringes or medication dispensers, allowing for localized treatment while the device is in use. The device is designed with rounded edges and contoured shapes to fit comfortably against the gums and teeth, ensuring that it does not create additional pressure points that could lead to pain.
[0033] In an embodiment, the silicone type of the device is medical-grade silicone elastomer. The durometer hardness is 20 to 50 Shore A (to ensure flexibility and comfort). overall length of the device is 10 to 15 cm (suitable for varying mouth sizes). The width of Inflatable Chambers is 2 to 5 cm (to accommodate different arch sizes). The thickness of Silicone Material is 1 to 3 mm (to maintain structural integrity while ensuring comfort). Inflation Pressure is 10 to 20 mmHg (to allow gradual expansion without causing pain). The Volume of Inflatable Chambers is 50 to 150 mL (to accommodate varying levels of trismus severity). Volume of Medication Dispensed is 0.5 to 5 mL per use (depending on the medication type and dosage). Flow Rate is 1 to 3 mL/min for medication delivery (to ensure controlled release). The duration of use is 20 to 60 minutes per session (to ensure effectiveness while preventing discomfort). The frequency of use is 2 to 4 times daily (to facilitate rehabilitation and improve mouth opening). One-Way Valve Pressure Limit has maximum allowable pressure of 25 mmHg before venting to prevent over-inflation. Temperature Range for Use is 15 to 40°C (suitable for patient comfort and material integrity). The recommended cleaning solution is mild soap or alcohol-based disinfectant (for safety and efficacy). Cleaning Frequency is after each use (to maintain hygiene),
[0034] FIG. 2 illustrates an exemplary flowchart explaining the method (200) of managing trismus in patients using a silicone-based inflatable device, in accordance with an embodiment of the present disclosure.
[0035] With reference to FIG. 2, at step 202, inserting the device (100) into a mouth of a patient and positioning at least two inflatable chambers against upper and lower arches.
[0036] At step 204, gradually inflating the chambers via a handle pump by the patient, thereby allowing for precise control of inflation level, enabling the patient to increase the distance of the mouth opening incrementally based on their comfort level.
[0037] At step 206, dispensing medications such as localized pain relief or muscle relaxants directly into oral cavity through a medication reservoir using a pre-filled syringe or a medication dispenser by a patient.
[0038] At step 208, deflating the chambers via the handle pump by the patient using a one-way valve allowing for controlled deflation, ensuring that the device (100) is easily removed without sudden changes in pressure. The device is designed to stretch and rehabilitate the affected muscles of the patient gradually and safely.
[0039] In an embodiment, the patient or caregiver gently inserts the device into the mouth, positioning the inflatable chambers against the upper and lower arches. Given its soft and flexible material, the device can be easily maneuvered into place even with minimal mouth opening. Using the integrated handle pump, the patient can gradually inflate the chambers. The pump allows for precise control of the inflation level, enabling the patient to increase the mouth opening distance incrementally based on their comfort level. Patients can inflate the device to a point that feels comfortable without causing excessive pain. Once the device is in place, medication can be administered through the reservoir. Patients can use a pre-filled syringe to deliver localized pain relief or muscle relaxants directly into the oral cavity. This simultaneous administration of medication during the use of the device ensures that patients receive immediate relief from discomfort while promoting muscle relaxation.
[0040] In an embodiment, after the desired treatment duration, the patient can deflate the device using the handle pump. The one-way valve allows for controlled deflation, ensuring that the device can be easily removed without sudden changes in pressure. The device is designed for regular daily use. Patients are encouraged to monitor their progress by gradually increasing the inflation over time. As they become more comfortable, they can aim to achieve greater mouth opening distances. This routine can be integrated into their rehabilitation exercises for trismus.
[0041] In an implementation of an embodiment, a patient with a history of head and neck cancer treatment experiences severe trismus, with a mouth opening of only 20 mm. The patient begins using the silicone-based inflatable device as part of their physiotherapy regimen. Day 1: The patient inserts the device and inflates it to a comfortable level (approximately significant increase in mouth opening). They also deliver a localized muscle relaxant via the medication reservoir. Week 1: With consistent daily use, the patient gradually increases the inflation, reaching a mouth opening of significant by the end of the week. The pain management provided by the device allows for better compliance with the exercises. Month 1: After one month of daily use, the patient achieves a mouth opening of 35 to 40 mm, significantly improving their ability to eat, speak, and maintain oral hygiene.
[0042] In an implementation of an embodiment, a patient suffering from trismus struggles with oral hygiene due to limited mouth opening, increasing the risk of opportunistic infections. The patient incorporates the inflatable device into their daily routine, using it to gradually increase mouth opening and improve access to the oral cavity for brushing and flossing. By inflating the device, they can now reach areas that were previously difficult to clean. The integrated medication delivery system allows for the application of antiseptic solutions, further aiding in maintaining oral hygiene. Over time, the patient's oral health improves significantly, reducing instances of cavities and infections, which were common due to their inability to clean their teeth effectively.
[0043] In an embodiment, a flexible, biocompatible body is constructed from medical-grade silicone, designed to minimize irritation and maximize comfort during prolonged use. Inflatable chambers are positioned between the upper and lower arches of the mouth, with compartments for gradual expansion to facilitate increased mouth opening. A hand-operated pump system, can be analogous to a blood pressure cuff, enabling precise inflation and deflation of the inflatable chambers for adjustable mouth expansion. A one-way valve system locks the air within the chambers to prevent unintended deflation, providing consistent therapeutic pressure and ensuring patient safety during use.
[0044] In an embodiment, inflatable components are located centrally in both the upper and lower arches, enabling targeted expansion to gently and gradually stretch the buccal and labial mucosa, improving mouth opening without inducing excessive strain. An internal medication delivery system allows for the administration of therapeutic agents, such as pain relievers or muscle relaxants, directly to the oral tissues while the device is in use, optimizing the trismus treatment process. The silicone-based inflatable device is inserted into the oral cavity, followed by controlled inflation over time, to stretch and rehabilitate the affected muscles gradually and safely. The body of the device features smooth, contoured surfaces and flexible silicone material to conform to the patient's mouth. The device promotes enhanced mouth opening, allowing for easier brushing, flossing, and general oral care, thereby reducing the risk of oral infections. The device supports the application of oral hygiene solutions directly through its integrated delivery channels.
[0045] In an exemplary embodiment, patients who have undergone radiation therapy or surgical procedures related to head and neck cancer, providing a non-invasive, flexible rehabilitation tool to mitigate the adverse effects of trismus. The gradual inflation process allows for incremental muscle stretching, reducing the risk of pain, tissue damage, or discomfort, while improving treatment compliance and patient outcomes. The combination of medical-grade silicone material, an integrated medication delivery system, centrally located inflatable chambers, and a user-friendly inflation mechanism, distinguishing it from rigid, metallic, or non-flexible alternatives in the market.
[0046] In an exemplary embodiment, the use of a silicone-based material significantly reduces the discomfort experienced during the use of current rigid devices. This soft, flexible material conforms to the patient's mouth, making it much more comfortable to wear for longer periods. The device fits both the upper and lower arches and can be worn with minimal discomfort, even in severe trismus cases. Unlike the rigid manual stretching of current devices, the present disclosure uses inflatable components located in the middle of the upper and lower arches. The inflation mechanism allows for precise control over the degree of mouth opening, enabling gradual, safe expansion. Patients can adjust the device according to their tolerance, which helps them achieve the desired mouth opening without causing additional pain or tissue damage.
[0047] In an exemplary embodiment, a significant innovation in this device is its ability to deliver medication directly to the oral cavity during use. This feature allows patients to receive localized pain relief and muscle relaxation, helping to reduce discomfort and spasms while using the device. The administration of medication, such as muscle relaxants or pain relievers, aids in maintaining comfort and increases the likelihood of consistent use. The device is designed with a simple inflation mechanism, similar to that of a blood pressure cuff, making it easy for patients to operate at home without requiring specialized assistance. The user-friendly design ensures that patients can manage their therapy independently, which improves compliance and long-term outcomes. The slow, incremental inflation of the device reduces the risk of tissue injury, which is a concern with more aggressive manual stretching devices. The controlled inflation mechanism ensures that the buccal and labial mucosa are gradually expanded, allowing the patient's mouth opening to increase without causing harm.
[0048] While the foregoing describes various embodiments of the invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are comprised to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
, Claims:1. A silicone-based inflatable device (100) for managing trismus in patients, the device (100) comprising:
a silicone body (102) configured to fit within oral cavity of a patient;
at least two inflatable chambers (104) embedded within the silicone body (102), designed to fit between upper and lower arches of the mouth to expand and provide controlled force for gradual mouth opening and gradual stretching of the buccal and labial mucosa;
an inflation mechanism having a handle pump operably connected to the inflatable chambers (104) to control the degree of inflation and deflation;
a medication reservoir integrated into the device, configured to dispense therapeutic agents directly into the oral cavity.
2. The device (100) as claimed in claim 1, wherein the inflation mechanism includes a one-way valve to ensure that air remains in the inflatable chambers (104) until the patient decides to deflate the device, providing consistent therapeutic pressure and ensuring patient safety during use.
3. The device (100) as claimed in claim 2, wherein the maximum allowable pressure of the one-way valve before venting is 25 mmHg to prevent over-inflation.
4. The device (100) as claimed in claim 1, wherein the device (100) is designed with rounded edges and contoured shapes to fit comfortably against the gums and teeth, ensuring that the device (100) does not create additional pressure points that leads to pain.
5. The device (100) as claimed in claim 1, wherein the silicone body (102) is a flexible, biocompatible body constructed from medical-grade silicone, designed to minimize irritation and maximize comfort during prolonged use.
6. The device (100) as claimed in claim 1, wherein the inflatable chambers (104) are provided with compartments for gradual expansion to facilitate increased mouth opening.
7. The device (100) as claimed in claim 1, wherein the device (100) is designed for accommodating various degrees of mouth opening, and ensuring long-term comfort during use.
8. A method (200) of managing trismus in patients using a silicone-based inflatable device (100), the method (200) comprising the steps:
inserting (202) the device (100) into a mouth of a patient and positioning at least two inflatable chambers (104) against upper and lower arches;
gradually inflating (204) the chambers via a handle pump by the patient, thereby allowing for precise control of inflation level, enabling the patient to increase the distance of the mouth opening incrementally based on their comfort level;
dispensing (206) medications such as localized pain relief or muscle relaxants directly into oral cavity through a medication reservoir using a pre-filled syringe or a medication dispenser by a patient;
deflating (208) the chambers via the handle pump by the patient using a one-way valve allowing for controlled deflation, ensuring that the device (100) is easily removed without sudden changes in pressure,
wherein the device is designed to stretch and rehabilitate the affected muscles of the patient gradually and safely.

Documents