ORAL APPLIANCE AS SWALLOWING AUXILIARY DEVICE WITH COVERAGE OF MAXILLARY TEETH AND A MANUFACTURING METHOD THEREOF

Abstract

An oral appliance as swallowing auxiliary device with coverage of maxillary teeth and a manufacturing method thereof are provided. The oral appliance comprises a retention framework and a palatal pad. The retention framework is manufactured according to the surface of maxillary dentition, and some case according to the surface of gingiva around the maxillary teeth together. The palatal pad corresponds to the swallowing and pronouncing functional position of tongue and palate. The oral appliance in the present invention is made by a first material and a second material, such as elastic and resiliently soft material, and it obtains well retention force by the material embracing the undercut between the path of insertion of the device and the surface of maxilla teeth or gingiva around the maxillary teeth. The oral appliance can get well retention to withstand the swallowing force and improve the functional performance as maximum tongue pressure, thereby improving the oral intake function and facilitating the dysphagia rehabilitation.

Claims

1. A swallowing auxiliary device with coverage of maxillary teeth, being placed and used in an oral cavity, there being maxillary dental arch, palate, tongue, and gingiva in the oral cavity, the swallowing auxiliary device comprising: a retention framework produced according to an arranged configuration form of the maxillary dental arch and configured to embrace the maxillary teeth; and a palatal pad, wherein the retention framework includes an outer frame, an inner frame, and a bottom frame, which includes a mutually connect for the outer, inner, and bottom frame, wherein the outer frame tightly embraces external labial or buccal surface of the maxillary teeth, the inner frame tightly embraces inner lingual surfaces of the maxillary teeth, and the bottom frame tightly contacts incisive edge or occlusal surface of the maxillary teeth, wherein the palatal pad is bound on the inner frame and corresponds in shape to a palatal space between the tongue and palate of the oral cavity during swallowing function.

2. The device according to claim 1, wherein the palatal pad includes an upper surface and a lower surface, the upper surface of the palatal pad corresponds in shape to the palate during swallowing function; or, the palatal pad extends from hard palate to soft palate during swallowing function.

3. The device according to claim 1, wherein the retention framework is made from a first material, and the palatal pad is made by a second material.

4. The device according to claim 3, wherein there are some missing teeth in maxillary dentition of the oral cavity; the retention framework covers a mucosa surface of missing teeth area, and a space between the outer frame, the inner frame, and the bottom frame is filled with the first material or the second material.

5. The device according to claim 1, wherein the palatal pad includes a baseplate and a colloid layer, the baseplate is formed on the inner frame of the retention framework, and the colloid layer is coated on a lower surface or two opposite surfaces of the baseplate.

6. The device according to claim 5, wherein at least one through hole is provided in the baseplate, and the colloid layer embeds the at least one through hole and is thereby bound on the baseplate.

7. The device according to claim 5, wherein the retention framework and the baseplate of the palatal pad are made from a first material, and the palatal pad is made by a second material.

8. The device according to claim 1, wherein the retention framework is produced on the teeth of the maxillary dental arch of a dental cast from dental impression; alternatively, the retention framework is produced by firstly obtaining 3D digital data of the maxillary dental arch with gingiva around maxillary teeth, and then constructing a digital model, depicting and shaping the retention framework on the digital model, then producing the retention framework with a 3D printing technology.

9. The device according to claim 1, wherein the retention framework includes a distal end connection between the outer frame and the inner frame, which enables well embracing coverage of the incisive edge and the occlusal surface of the teeth of the maxillary dental arch.

10. The device according to claim 1, wherein the retention framework is produced according to the arranged configuration of the teeth of the maxillary dental arch and covers the gingiva around the maxillary teeth.

11. A method for producing a swallowing auxiliary device with coverage of maxillary teeth, placed and used in an oral cavity, there being maxillary dental arch, palate, tongue, and gingiva in the oral cavity, the method comprising: producing a retention framework according to an arranged configuration form of the maxillary dental arch, the retention framework being configured to embrace the maxillary teeth, wherein the retention framework includes an outer frame, an inner frame, and a bottom frame, which includes a mutually connect for the outer, inner, and bottom frame; wherein the outer frame tightly embraces external labial or buccal surface of the maxillary teeth, the inner frame tightly embraces inner lingual surfaces of the maxillary teeth, and the bottom frame tightly contacts incisive edge or occlusal surface of the maxillary teeth; and producing a palatal pad on the inner frame.

12. The method according to claim 11, wherein the palatal pad is connected to the retention framework and includes an upper surface and a lower surface, the upper surface of the palatal pad corresponds in shape to the palate; or, the palatal pad extends from hard palate to soft palate.

13. The method according to claim 11, wherein the retention framework is made from a first material, and the palatal pad is made by a second material.

14. The method according to claim 13, wherein a baseplate is firstly formed on the inner frame of the retention framework, and then uncured said second material is coated on a lower surface of the baseplate, then the palatal pad is formed after said second material is cured; or, the uncured second material is coated on both the upper and lower surfaces of the baseplate, then the palatal pad is formed after said second material is cured.

15. The method according to claim 13, wherein the method further comprises: connecting an embryonic palatal pad made by uncured said second material to the inner frame; asking a patient to wear the retention framework on the maxillary dental arch, and to pronounce or swallow to shape the embryonic palatal pad so that a lower surface of the embryonic palatal pad corresponds in position to the tongue of the oral cavity as the tongue presses upward against the embryonic palatal pad, and that an upper surface of the embryonic palatal pad corresponds in position to a hard palate of the oral cavity, or that the hard palate and a soft palate of the oral cavity jointly shape the embryonic palatal pad; and waiting the embryonic palatal pad cured to be the palatal pad.

16. The method according to claim 13, wherein there are some missing teeth in maxilla dentition of the oral cavity, covers a mucosa surface of missing teeth area, and a space between the outer frame, the inner frame, and the bottom frame is filled with the first material or the second material.

17. The method according to claim 11, wherein the retention framework is produced on the teeth of the maxillary dental arch of a dental cast from dental impression; alternatively, the retention framework is produced by firstly obtaining 3D digital data of the maxillary dental arch with gingiva around maxillary teeth, and then constructing a digital model, depicting and shaping the retention framework on the digital model, then producing the retention framework with a 3D printing technology.

18. The method according to claim 11, wherein the retention framework includes a distal end connection between the outer frame and the inner frame, which enables well embracing coverage of the incisive edge and the occlusal surface of the teeth of the maxillary dental arch.

19. The method according to claim 11, wherein the retention framework is produced according to the arranged configuration of the teeth of the maxillary dental arch and covers the gingiva around the maxillary teeth.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0046] FIG. 1 is a three-dimensional external view of an oral appliance as swallowing auxiliary device of the present invention not yet being placed inside the oral cavity for shaping, wherein a baseplate of palatal pad is not yet coated with a colloid layer.

[0047] FIG. 2 is a three-dimensional external view of an oral appliance as swallowing auxiliary device of the present invention ready to be placed inside the oral cavity for shaping, wherein the baseplate of palatal pad is already coated with colloid layers.

[0048] FIG. 3 is a bottom view of FIG. 2.

[0049] FIG. 4 is a schematic view depicting fitting the present invention, whereby a patient does not swallow and does not use tongue press up on the embryonic palatal pad yet.

[0050] FIG. 5 is a schematic view depicting fitting the present invention, whereby a patient does swallow and uses tongue press up on the embryonic palatal pad, causing the embryonic palatal pad to be molded and shaped the lower surface according to the contour form of the tongue elevation during swallowing, and upper surface according to the functional palate form in the oral cavity.

[0051] FIG. 6 is an external view of a swallowing auxiliary device of the present invention fitted on the patient's maxillary dental arch and palate with the shaped palatal pad.

[0052] FIG. 7 is a three-dimensional external view of the second manufacturing method for a swallowing auxiliary device of the present invention, the separate retention framework baseplate not yet being placed inside the oral cavity for shaping, wherein it is not yet coated with a colloid layer.

[0053] FIG. 8 is a schematic view of the second manufacturing method for an auxiliary binding structure formed on an inner frame of the retention framework of the present invention that firmly connects and fixes the palatal pad by the cured colloid layers.

[0054] FIG. 9 is a bottom view of FIG. 8.

[0055] FIG. 10 is a three-dimensional external view of the third manufacturing method for a swallowing auxiliary device of the present invention. There are some missing teeth in the maxilla dentition. The baseplate of retention framework can include the form of missing teeth and gingiva around the missing teeth, then we fill the space in the framework by baseplate material or resiliently soft material and cover the mucosa surface of missing teeth area by the retention framework. The baseplate not yet being placed inside the oral cavity for shaping, wherein it is not yet coated with a colloid layer.

[0056] FIG. 11 is a schematic view of the third manufacturing method for a swallowing auxiliary device of the present invention that firmly connects and embraces the maxillary dentition.

[0057] FIG. 12 is a bottom view of FIG. 11.

[0058] FIG. 13 is a three-dimensional external view of the fourth manufacturing method for a swallowing auxiliary device of the present invention, the baseplate of retention framework is extended to the gingiva around the maxillary teeth. The baseplate not yet being placed inside the oral cavity for shaping, wherein it is not yet coated with a colloid layer.

[0059] FIG. 14 is a schematic view of the fourth manufacturing method for a swallowing auxiliary device of the present invention that firmly connects and embraces the maxillary dentition.

[0060] FIG. 15 is a bottom view of FIG. 14.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0061] Based on the above-described technological characteristics of the present invention, the main effects of an oral appliance as swallowing auxiliary device with coverage of maxillary teeth and a manufacturing method thereof are clearly presented in the following embodiments.

[0062] Referring to FIGS. 1 to 6, which show the first manufacturing method of a swallowing auxiliary device of the present invention, being placed and be used inside the oral cavity. There are maxillary dental arch (A), palate (B), and tongue (C) in the oral cavity. (FIGS. 4)

[0063] Wherein a retention framework (1) is produced according to the arranged configuration of maxillary dental arch (A) form. A first material, such as elastic material like thin thermoplastic resin plate, is used to shape and produce the retention framework (1). The maxillary dental arch (A) form is according to a dental stone cast, or 3D digital data of the dental arch is first obtained, we construct a digital model, and then a 3D shape of the retention framework (1) is depicted and shaped on the digital model. Then we produce the retention framework by elastic material on the dental cast, or by the 3D printing technology.

[0064] Accordingly, the retention framework (1) assumes a dental arch form, which includes an outer frame (11) and an inner frame (12), and a bottom frame (13) that is formed between the outer frame (11) and the inner frame (12).

[0065] Then, an un-cured said second material such as resiliently soft material like denture soft liner, is used to make an embryonic palatal pad (2), which is on the baseplate of palatal pad (21) extended from the inner frame (12) of retention framework (1). The material used for the baseplate (21) and the retention framework (1) is made by said first material, such as thin resin plate, and the two opposite surfaces of the baseplate of palatal pad (21) are respectively coated with colloid layers (22), which is an uncured said second material such as resiliently soft material.

[0066] In order to enable the colloid layers (22) to firmly bind to the inner frame (12) of the retention framework (1) without easily coming loose, an auxiliary binding structure provided with several through holes (211) is disposed on the inner frame to fix the embryonic palatal pad (2). wherein the auxiliary binding structure of the present embodiment is a spaced arrangement of a plurality of through holes (211) in the baseplate of palatal pad (21). The colloid layers (22) are embedded in the above-described through holes (211) during the process of forming thereof, which firmly binds the colloid layers (22) to baseplate of palatal pad (21) after forming the palatal pad (200) and enables extension the serviceable life of the palatal pad.

[0067] Referring to FIG. 2 and FIG. 3, the retention framework (1) is worn on the maxillary dental arch (A) in the patient's oral cavity, wherein the outer frame (11) tightly embraces the external buccal surfaces of the maxillary dental arch (A), the inner frame (12) tightly embraces the inner lingual surfaces of teeth, the bottom frame (13) tightly contacts the incisive edge or occlusal surface of maxillary teeth, and the embryonic palatal pad (2) can contact the palate (B).

[0068] Producing the retention framework (1) according to the arranged configuration of the teeth of maxillary dental arch (A), wherein the retention framework includes the distal end connection between outer frame and inner frame, that enables well embracing coverage of the incisive edge and the occlusal surface of the teeth of maxillary dental arch (A), get a good stability to prevent oral appliance rocking during chewing and swallowing.

[0069] The material used for the baseplate of palatal pad (21) and the retention framework (1) is elastic material, and an uncured said second material is used to make an embryonic palatal pad (2), they make the oral appliance soft and elastic, thus providing better comfortable sensation when in use.

[0070] Referring to FIGS. 4, 5, 6, which show fitting retention framework (1) of the present invention on maxillary dental arch (A), whereby ask the patient to pronounce and swallow and uses tongue (C) to press up on the embryonic palatal pad (2) , the pressure can shape the embryonic palatal pad (2) form corresponds to the functional position and form of palate and tongue, include the lower surface contacting functional tongue in oral cavity and maxillary surface contacting on the palate (B) mucosa in function. The patient waits for the resiliently soft material shaping and cured, after which the palatal pad (200) is made. The palatal pad (200) can be extended from hard palate to soft palate, it can get more contact surface to palate (B). Since the custom-made present invention fitted on the patient's maxillary dental arch and patient's palate with the shaped palatal pad in function, it can get good embarrassing and stability, thus providing better comfort when in use.

[0071] The customized palatal pad (200) can be also adapted to the tongue elevation position during pronouncing and swallowing of different patients or different needs of training. The palatal pad (200) can shorten the distance that tongue (C) presses up on to generate tongue pressure movement to contact and press. Monitoring by maximum tongue pressure measuring device, we can add or remove some thickness of the colloid layer (22) on lower surface of palatal pad (200) to modify the maximum tongue pressure to meet the safety (such as over 20kPa) or proper training needs of different swallowing training stage. If we need to raise the maximum tongue pressure, we can add some thickness of colloid layer (22). After a period of training, such as 1 to 3 months, if the maximum tongue pressure is improved and we need to shift the training goal to more training strength way, we can remove some thickness of colloid layer (22). If the maximum tongue pressure drops down gradually during the long term follow up, we can add some thickness of colloid layer (22). For the safety consideration, the training maximum tongue pressure should over 20kPa with the present invention.

[0072] Referring to FIG. 7, 8, 9, the second manufacturing method for a swallowing auxiliary device of the present invention is presented. The retention framework (1a) and baseplate of palatal pad (21a) are made separately. The retention framework is not yet being placed inside the oral cavity in FIG. 7, wherein it is not yet coated with colloid layers. The separate baseplate of palatal pad with or without embryonic palatal pad can be pre-formed by different pre-formed size, or custom-made on maxillary dental cast, or by the digital data obtained from scanning and made by 3D printer. There is auxiliary bonding structure provided with several holes (211a) through the inner frame (12a) of the retention framework (la), and several holes (211) through the separate baseplate of palatal pad (21a). The holes (211,211a) can help the inner frame(12a) bind the separate palatal pad baseplate (21a) with the colloid layers (22a) embedded in the above-described through holes (211a) during the process of forming thereof, which firmly binds the colloid layers (22a) to the inner frame (12a).

[0073] Referring to FIG. 10, 11, 12, the third manufacturing method for a swallowing auxiliary device of the present invention is presented. There are some missing teeth (A1) in the maxillary dental arch (A). During the is missing teeth area, the retention framework (1b) made as the form of missing teeth and gingiva, by wax-up reconstruction dental cast or 3D digital data reconstruction model. The space in the framework, between the outer frame (11b), the inner frame (12b), and the bottom frame (13b), such as the form of missing teeth and gingiva, is filled by said first and second material. That can reinforce the structure strength of the retention framework (1b) and improve the stability and comfortable sensation when use the appliance, prevent framework fracture during chewing and swallowing.

[0074] Referring to FIG. 13, 14, 15, the fourth manufacturing method for a swallowing auxiliary device of the present invention is presented. The retention framework (1c) not only cover the maxillary dental arch (A), but also is extended to some gingiva around the maxillary teeth (D). The enhancing coverage and embracing can get more structure strength of retention framework (1c), that can make more retention and stability of the device in oral cavity during chewing and swallowing.

[0075] The present invention is a custom-made oral appliance, the retention framework (1,1a,1b,1c) is well fitted and embraces the maxillary dental arch (A), which facilitates firmly binding the retention framework onto the maxillary dental arch and reduces the sensation of having a foreign body inside the oral cavity when in use. Good retention for the oral appliance is very important for patient, whether to speak or chew food, thereby increasing the degree of comfort sensation when in use the device, improving the patient's willingness to use the device.

[0076] Mounting of the retention framework (1,1a,1b,1c) on the teeth of maxillary dental arch (A), may some gingiva around the maxillary teeth (D) around the maxillary teeth, enables more retention and stability for the device during oral function.

[0077] We can utilize said first and second material, such as elastic and resiliently soft material, in proper undercut around the maxilla teeth for proper retention force. We can adjust the retention force from the amount of undercut, such as adjust the path of insertion, and/or cut off some of the outer frame of retention framework which cover the undercut area of the maxillary dental arch (A).

[0078] Comparing to the prior art of palatal augmentation pad, made by hard resin, by the manufacturing method of the swallowing auxiliary device of the present invention we can relatively quickly finish the manufacture procedures to meet the needs of early dysphagia rehabilitation. The importance of early intervention and training for dysphagia patient had been proved already, such as for stroke patient.

[0079] The manufacturing method of the swallowing auxiliary device of the present invention is relatively simple, we can make it bedside for patient. It can be well done during home healthcare, nursing home healthcare, or facility healthcare.

[0080] In summary, the above description of the embodiments provides a clear understanding of the manufacturing methods and the effectiveness achieved by the present invention. However, it is of course to be understood that the embodiments described herein are merely illustrative of the principles of the invention and that a wide variety of modifications thereto may be affected by persons skilled in the art without departing from the spirit and scope of the invention as set forth in the following claims.