CN110811875A

CN110811875A - Film for manufacturing tooth socket, tooth socket and method for manufacturing tooth socket

Info

Publication number: CN110811875A
Application number: CN201911173010.4A
Authority: CN
Inventors: 黄成源
Original assignee: Shanghai Yunquan New Material Technology Co Ltd
Current assignee: Shanghai Markus Medical Technology Co.,Ltd.
Priority date: 2019-11-26
Filing date: 2019-11-26
Publication date: 2020-02-21

Abstract

The invention relates to a diaphragm for manufacturing a tooth socket, the tooth socket and a method for manufacturing the tooth socket. The diaphragm provided by the invention has at least two hardness, the hardness can be designed according to the required correction force, and the areas with different hardness can be designed according to the actual condition of the teeth, so that the sheet body part with corresponding hardness can be designed according to different correction forces, and after the tooth socket is manufactured according to the sheet body, the corresponding correction force can be provided for the corresponding tooth part, thereby improving the correction effect and shortening the correction period.

Description

Film for manufacturing tooth socket, tooth socket and method for manufacturing tooth socket

Technical Field

The invention relates to the field of medical instruments, in particular to a diaphragm for manufacturing a tooth socket, the tooth socket and a method for manufacturing the tooth socket.

Background

Orthodontics, i.e. correcting tooth deformities, applies external forces to displace teeth through worn aligners, thereby achieving the purpose of realignment. Traditional ware of rescuring is the metal braces, adopts nickel titanium alloy arch wire and metal support groove to cooperate to form usually, and this kind of ware of rescuring can be fine reaches treatment, but it is pleasing to the eye, comfortable inadequately, and wearing in-process arch wire and holding in the palm the groove and can amazing the oral cavity, causes the foreign body to feel, and the arch wire with hold in the palm remains the disintegrating slag on the groove, breed the bacterium easily.

In order to solve the problems of the traditional metal braces, the invisible braces (also called invisible orthodontic appliances) are suitable for transportation, compared with the traditional orthodontic appliances, the bracket-free invisible braces are safer and more comfortable, can not scratch oral tissues because of fixing the bracket, can not influence the beauty of the oral cavity after being worn, can be worn by oneself, and are easy to clean. The invisible tooth socket is made of elastic material, and has the treatment principle that when the invisible tooth socket is worn, the invisible tooth socket generates certain elastic deformation, and the elastic deformation generates acting force on teeth in the recovery process to push the teeth to move so as to achieve the aim of correction. The invisible braces are made of transparent plastic materials, the diaphragm for manufacturing the invisible braces is a single sheet with hardness, all the positions of the invisible braces only have the same correcting force, and the actual situation is that the correcting force required by all the positions of teeth is different, so that the correcting effect of the existing invisible braces is not obvious, or the correcting period needs to be very long.

Disclosure of Invention

The invention aims to overcome the defects of the prior art, provides a diaphragm for manufacturing a tooth socket, the tooth socket and a method for manufacturing the tooth socket, and solves the problems that the existing invisible tooth socket only has one hardness, so that the correction effect is not obvious or the correction period is long.

The technical scheme for realizing the purpose is as follows:

the invention provides a diaphragm for manufacturing a tooth socket, which comprises a sheet body, wherein the sheet body comprises at least two parts which are in butt joint, and the hardness of the at least two parts is different.

The diaphragm provided by the invention has at least two hardness, the hardness can be designed according to the required correction force, and the areas with different hardness can be designed according to the actual condition of the teeth, so that the sheet body part with corresponding hardness can be designed according to different correction forces, and after the tooth socket is manufactured according to the sheet body, the corresponding correction force can be provided for the corresponding tooth part, thereby improving the correction effect and shortening the correction period.

The diaphragm for manufacturing the tooth socket is further improved in that one part of the at least two parts is positioned at the inner side of the other part; or

The at least two portions each have a portion located at the periphery of the blade.

A further improvement of the membrane for making a mouthpiece according to the invention is that the at least two portions are of uniform thickness.

A further improvement of the membrane for making a mouthpiece according to the invention is that the material of the at least two parts is different or the same.

The diaphragm for manufacturing the tooth socket is further improved in that the diaphragm body is a foaming section, uniformly distributed foam holes are formed in the diaphragm body, and the foam holes are not closed.

In a further improvement of the film for making a mouthpiece of the present invention, the sheet comprises at least two sheets, the at least two sheets having a differential hardness therebetween.

The invention also provides a tooth socket which is made of the membrane.

The invention also provides a method for manufacturing a tooth socket by using the diaphragm, which comprises the following steps:

preparing a diaphragm according to a tooth correcting scheme, wherein the prepared diaphragm comprises at least two parts which are in butt joint connection, and the hardness of the at least two parts is different;

the tooth socket is formed by processing the prepared film, and the hardness of at least two parts of the formed tooth socket is different.

The method of the invention is further improved in that the method further comprises the following steps:

when the diaphragm is manufactured, a physical gas foaming method is utilized to prepare a formed diaphragm, the formed diaphragm is a foaming section, and uniformly distributed foam holes are formed in the formed diaphragm;

puncturing the membrane by using a needle to enable the foam hole inside the membrane to be in a non-closed state;

after the tooth socket is processed and formed, the active ingredients can be adsorbed and stored by utilizing the non-closed foam pores.

A further improvement of the method of the invention is the step of producing the diaphragm according to a dental appliance regimen comprising:

s11, dividing regions according to a tooth correction scheme to form at least two regions, wherein the hardness required by the at least two regions is different;

s12, providing a mold, forming a first model space corresponding to one of the at least two areas in a separated mode in the mold, and manufacturing a first part with corresponding hardness through the first model space;

s13, forming a second model space corresponding to the next area in the at least two areas in the mold in a separated mode, connecting the second model space with the corresponding edge of the first part, manufacturing a second part with corresponding hardness through the second model space, and connecting the second part and the first part into a whole in a butt joint mode;

s14, repeating the step S13 until each of the at least two areas is manufactured to have a corresponding part, and obtaining the required membrane.

Drawings

FIG. 1 is a schematic structural view of a first embodiment of a film for making a mouthpiece according to the present invention.

FIG. 2 is a schematic structural diagram of a second embodiment of the film used for making the mouthpiece of the present invention.

FIG. 3 is a schematic structural diagram of a third embodiment of the film for making a mouthpiece according to the present invention.

FIG. 4 is a schematic structural diagram of a fourth embodiment of the film used for making the mouthpiece of the present invention.

FIG. 5 is a schematic structural diagram of a fifth embodiment of a film used for making a mouthpiece according to the present invention.

FIG. 6 is a schematic structural diagram of a diaphragm used for manufacturing a mouthpiece according to a sixth embodiment of the present invention.

FIG. 7 is a schematic structural diagram of a dental model placement area provided on a first embodiment of a film for making a dental mouthpiece according to the present invention.

FIG. 8 is a schematic structural diagram of a dental model placement area provided on a third embodiment of a film for making a dental mouthpiece according to the present invention.

Figure 9 is a cross-sectional view of a film used to make a mouthpiece of the present invention.

Detailed Description

The invention is further described with reference to the following figures and specific examples.

Referring to fig. 1, the invention provides a diaphragm for manufacturing a mouthpiece, the mouthpiece and a method for manufacturing the mouthpiece, which are used for solving the problem that the existing mouthpiece only has single hardness and is difficult to meet the requirements of different orthodontic forces of different teeth, so that the existing mouthpiece has an unobvious orthodontic effect or a long orthodontic period. The diaphragm comprises at least two parts which are in butt joint, and the hardness of the at least two parts is different, so that different correction strength is realized on one tooth socket, the hardness which is actually required can be matched, the teeth can be corrected in a targeted manner, the correction effect is improved, and the correction period is shortened. The film for manufacturing the mouthpiece, the mouthpiece and the method for manufacturing the mouthpiece of the present invention will be described below with reference to the accompanying drawings.

Referring to FIG. 1, a schematic structural diagram of a first embodiment of a film for making a mouthpiece according to the present invention is shown. The film for making the mouthpiece of the present invention will be described with reference to fig. 1.

As shown in FIG. 1, the film for making a mouthpiece of the present invention comprises a sheet 20, and the sheet 20 comprises at least two portions connected in a butt joint, and the at least two portions have different hardness.

In the embodiment shown in fig. 1, blade 20 includes a first portion 21a and a second portion 21b, and first portion 21a and second portion 21b are integrally connected to form blade 20.

The sheet body 20 has at least two parts with different hardness, and the hardness of the corresponding part can be matched with the correction force of the required tooth part, so that the targeted correction force can be provided for each tooth, the correction effect can be improved, and the correction period can be shortened.

In a specific embodiment, at least two parts of sheet body 20 adopt thermoplastic material to make, and utilize thermoplastic material to be heated softening, the characteristic of cooling hardening and make can hot melt connection between each part in at least two parts become one whole, and no butt joint seam, the wholeness is good, and the fastness is high. Wherein each part of at least two parts is molded in sequence, the first molded part is placed in a mold of the second molded part, and the second molded part melts the butt joint surface part of the first molded part in a hot melting state and then is molded into a whole.

Preferably, the material of sheet 20 may be one or more selected from polyurethane, 1, 4-cyclohexanedimethanol terephthalate, and polycarbonate. The polyurethane, 1, 4-cyclohexanedimethanol terephthalate, and polycarbonate can be formulated to achieve a desired hardness, characterized herein as shore D, ranging from 30D to 90D, with type D being used for higher hardness materials.

Further, at least two portions of sheet 20 are of different materials, i.e. different hardnesses are achieved by different materials. Alternatively, at least two portions of sheet 20 are the same material, and the at least two portions are made of the same material to have different hardnesses.

Preferably, the material of at least two portions of sheet 20 is selected from one of polyurethane, polyethylene terephthalate-1, 4-cyclohexanedimethanol, and polycarbonate. The materials selected for the at least two portions may be the same or different.

Still further, various portions of sheet 20 may be injection molded, extruded, or thermoformed.

In one embodiment, at least two portions of blade 20 have a uniform thickness, i.e., blade 20 has a uniform thickness, and both the upper and lower surfaces of blade 20 are flat when viewed from the side. Utilize the diaphragm preparation facing of thickness unanimity, the thickness of each position of the facing that forms is even, wears comfortablely, and the oral cavity does not have the foreign matter and feels, if the thickness of facing is thicker, can amazing the tongue and secrete saliva to make the comfort reduce.

Further, sheet 20 has a thickness of between 0.1mm and 3 mm. The thickness of the tooth socket formed by processing is about 1.00mm, and when the thickness is more than 1.00mm, the tooth socket can be worn with foreign body sensation and is poor in comfort. The thickness of blade 20 is preferably between 0.1mm and 2.00mm, and the thickness of blade 20 is preferably 0.4mm, 0.67mm, 0.76mm, 1.00mm, 1.5mm, or 2 mm.

In one embodiment, one of the at least two portions of blade 20 is located inboard of the remaining portions. Thus, a sheet shape is formed in which one portion is enclosed inside by the other portion.

As shown in fig. 1, a first embodiment of the membrane is shown, in which a first portion 21a is arranged at the periphery of a second portion 21b, which first portion 21a encloses the second portion 21b, and the second portion 21b is shaped like a horseshoe, and the periphery of the second portion 21b is arc-shaped, which arc-shaped is adapted to the shape of the dental model. Referring to fig. 7, the dental cast setting area 10 is disposed at the intersection of the first portion 21a and the second portion 21b, so that the side of the dental cast near the lips and the side of the dental cast near the tongue have different hardness, and the dental cast can be pushed against the teeth in the direction of the lips or the tongue, so as to achieve the orthodontic function. The diaphragm of this first embodiment may be injection molded by first injection molding the first portion and then injection molding the second portion within the first portion.

As shown in fig. 2, a second embodiment of the membrane is shown, in which the first portion 21a is provided at the periphery of a second portion 21b, which second portion 21b and first portion 21a are both circular. If the dental model is placed on the film of the second embodiment, it is possible to realize that the incisor part and the molar part of the mouthpiece have different hardness, the cuspid and premolar parts are located at the junction of the first portion 21a and the second portion 21b, and further, the sides of the portions close to the lip and the tongue have different hardness.

In the first and second embodiments, the shape of the second portion 21b is circular or similar to a horseshoe, but the shape of the second portion 21b is not limited thereto, and the shape of the second portion 21b can be adaptively adjusted according to the position of the desired hardness, and may be a regular geometric shape or an irregular geometric shape.

In one embodiment, at least two portions of blade 20 are each partially located at the periphery of blade 20. Thus, a shape is formed in which each portion has an edge located at the edge of the sheet body.

As shown in fig. 3, a third embodiment of the membrane is shown, in which the first part 21a and the second part 21b are provided with curved abutting edges, wherein the first part 21a is crescent shaped and the second part 21b is oblate spheroid shaped with two pointed ends. Referring to fig. 8, the dental model arrangement region 10 is disposed at the junction of the first portion 21a and the second portion 21b, so that the incisor and molar portions of the shell are formed to have different hardness, and the cuspid and premolar portions are formed at the junction of the first portion 21a and the second portion 21b, so that the portions have different hardness at the sides adjacent to the lip portion and the tongue portion.

As shown in fig. 4, a fourth embodiment of the membrane is shown, in which the first portion 21a and the second portion 21b are each semicircular in shape, the first portion 21a and the second portion 21b being butted to form a sheet 20 in a circular shape. The film of the fourth embodiment can be formed by co-extrusion through an extrusion process, i.e., two extruders are arranged in parallel, and the two materials extruded from the extrusion ports are butted and cooled to form the required sheet.

As shown in fig. 5, a fifth embodiment of the membrane is shown, in which the first portion 21a and the second portion 21b are each in the shape of sectors of a circle, the angular arc of the two sectors being different, the sum of the two angular arcs being 360 °, the first portion 21a and the second portion 21b being butted to form a circular sheet 20.

As shown in fig. 6, a sixth embodiment of the membrane is shown, in which the blade 20 comprises three portions, a first portion 21a, a second portion 21b and a third portion 21c, the first portion 21a, the second portion 21b and the third portion 21c bisecting a circle.

The sheet body 20 of the film sheet of the present invention is transparent, and the filling shown in fig. 1 to 6 is for dividing each region.

In one embodiment, sheet 20 is a foamed profile having uniformly distributed cells therein. The portions of sheet 20 have different hardness by controlling the foaming density. The pores on the surface of the sheet body 20 are changed into non-closed pores in a needling mode, so that the pores on the surface have a storage space, active ingredients can be adsorbed and stored by using the storage space, and the tooth socket formed by processing can have a corresponding active function.

Preferably, when the mouthpiece is manufactured using the sheet 20 having non-closed cells, the non-closed cells are provided on the inner side of the mouthpiece, i.e., the side of the mouthpiece that contacts the teeth when worn. Therefore, the active ingredients stored in the non-closed cells can be gradually reserved and attached to the surface of the teeth, and further the corresponding functions are realized.

Further, the active ingredient may be a whitening ingredient, a disinfecting ingredient, a tooth stain removing ingredient, an anti-sensitivity ingredient, a tooth decay preventing ingredient or other ingredients having pharmacological effects. Further, the tooth whitening, disinfecting, tooth stain removing, tooth sensitivity resisting, tooth decay preventing, or tooth health promoting functions can be realized in the process of correcting teeth.

Specifically, the active ingredient may be one or more of a mixed solution of 5% potassium nitrate and 1400ppm sodium fluoride, a 1000ppm sodium fluoride solution, a mixed solution of 8% strontium acetate and 1000ppm sodium fluoride, hydrogen peroxide, urea peroxide, calcium peroxide, sodium pyrophosphate peroxide, sodium bicarbonate, chlorine-based bleaching powder, and fluoride. The active component can also be one or more of natural materials such as green salt, fructus Zanthoxyli, radix Saposhnikoviae, radix Angelicae Dahuricae and herba asari.

The tooth socket has the adsorption function by designing the non-closed foam holes on the sheet body, the foaming section has certain elasticity, the hardness of the foaming section can be controlled by controlling the foaming density, and in the process of correcting teeth, active liquid medicine with various functions is adsorbed, and when the tooth socket is worn, the active liquid medicine is released from the foam holes to realize the corresponding active function on the teeth. When the tooth socket is used, the tooth socket can be soaked in liquid medicine dissolved with corresponding active ingredients, the liquid medicine can gradually permeate into the non-closed foam holes of the tooth socket, then the liquid medicine is gradually released onto teeth in the wearing process, and the tooth socket is simple and convenient to use.

Still further, sheet 20 is foamed with a physical gasThe method has the advantages that the use of chemical foaming agents is avoided, the material is safer and more environment-friendly, and the threat of the tooth socket material to the health of human bodies is avoided. Preferably, sheet 20 is made from a polyurethane material by a physical gas foaming process in the presence of a physical gas blowing agent, and has a foam density of 0.2g/cm³To 0.6g/cm³The foam holes in the foamed section formed by foaming are all closed, and after the foamed section is prepared, the foam holes are changed into non-closed holes in a needling mode, so that the foamed section has an adsorption storage function.

In one embodiment, as shown in FIG. 9, panel 20 includes at least two panels that differ in stiffness between the at least two panels. In the example shown in fig. 9, the sheet 20 includes two sheets, a first sheet 22a and a second sheet 22b, and the first sheet 22a and the second sheet 22b have different hardness, specifically, the first sheet 22a and the second sheet 22b can have different hardness by designing different thicknesses, and can also have different hardness by selecting different materials, or different hardness by selecting the same material by adjusting the formulation. In this embodiment, sheet 20 includes at least two portions that are butt-joined, the overall thickness of the two portions being the same, but the thicknesses of the individual sheets in the two portions being different, the thicknesses of the different sheets being selected so that the stiffness of the portions is different.

Further, the outer sheet of the at least two sheets is a foamed section, so that the outer sheet has certain flexibility, and the outer sheet can be arranged on the upper surface of the sheet body 20 or on the lower surface of the sheet body 20. After processing into the facing like this, this flexible lamella can be located the inboard of facing, the one side that contacts with the tooth when also wearing, also can be located the outside of facing, the one side that does not contact with the tooth when also wearing, improve the travelling comfort of wearing through soft lamella, and flexible lamella can provide certain cushioning effect for the facing, play the effect that prevents to grind the tooth, can protect the tooth when the person of wearing grinds the tooth promptly, reduce the sound that grinds the tooth and send, when soft lamella is located the outside of facing, can realize avoiding the sound that the tooth sent.

Preferably, the diaphragm for making the mouthpiece of the present invention may be shaped as a circle, a square, or other regular geometric shapes, and may also be shaped as an irregular shape.

In one embodiment, first portion 21a and second portion 21b of sheet 20 have different thicknesses, by which different hardnesses, i.e. different mechanical properties, are achieved. Preferably, the first portion 21a and the second portion 21b having different thicknesses may be formed by combining a single sheet layer by heat pressing, and the total thickness of the first portion 21a and the second portion 21b is different in the combined design. Preferably, the first portion 21a and the second portion 21b may be made of the same material, or different materials, such as polyurethane, polyester, and polycarbonate. The diaphragm with different thicknesses can be used for solving the problems that the diaphragm with various thicknesses is needed in some applications such as the invisible tooth socket, and the cost is too high due to too many production specifications. The combination of different materials can also result in composite material membranes with different properties and thus corresponding mechanical properties, for example, TPU can be combined with PETG or two layers of TPU can sandwich one layer of PETG.

Theoretically, the membrane of the present invention can be designed to have a plurality of hardness portions corresponding to each tooth, but from the actual correction case, the difference of the correction force of the mouthpiece is basically at the front and back of the mouthpiece or at the side of the mouthpiece close to the lip and the side of the mouthpiece close to the tongue, so it is more common to design the membrane of two hardness, and the preparation process of the membrane of the present invention will be described below by taking the preparation of the membrane of two hardness as an example.

Firstly, dividing the zone into two zones according to a tooth correcting scheme, wherein the hardness of the two zones is designed according to the required correcting strength. Providing a mould, forming a mould space matched with the first area in the mould in a separated mode, then forming the first part in the first mould space through an injection moulding process, then taking out the separating body, so that the residual space in the mould is matched with the shape of the second area, and forming the second part into the residual space through the injection moulding process, wherein the second part is integrally butted with the first part, thereby forming the diaphragm in the mould. The temperature during the manufacturing process may be between 180 ℃ and 240 ℃, and the raw material of the second part may melt the edge of the first part when it comes into contact with the formed first part, and then the first part and the second part may be formed as one piece when formed.

The invention also provides a tooth socket which is made of the membrane. The tooth socket is a transparent tooth socket and is used for correcting teeth, and the formed tooth socket also has different hardness corresponding to different hardness due to different hardness of the film, and the hardness can be matched with the correction force required by the teeth.

The invention also provides a method for manufacturing the tooth socket by using the diaphragm, which is explained below.

The method for manufacturing the tooth socket by utilizing the membrane comprises the following steps:

Specifically, the diaphragm and the dental model are positioned in the mold, then the mold is heated to melt the diaphragm, the diaphragm is wrapped on the dental model, and after molding, redundant parts are cut off, so that the tooth socket matched with the dental model is formed. Preferably, when the dental mouthpiece is manufactured, the mold is evacuated so that the melted film is tightly wrapped on the dental model.

In a specific embodiment, the method further comprises the following steps:

The non-closed foam pores can store a certain amount of liquid medicine containing active ingredients, and the functions of the tooth socket can be enhanced, so that the tooth socket has the effects of whitening, disinfecting, cleaning, health care and the like.

In one embodiment, the step of forming the diaphragm according to a dental appliance comprises:

s11, dividing regions according to a tooth correction scheme to form at least two regions, wherein the hardness required by the at least two regions is different; specifically, the hardness of each region is designed according to the required correction strength.

S12, providing a mold, forming a first model space of one area of at least two corresponding areas in the mold in a separated mode, and manufacturing a first part with corresponding hardness through the first model space; in particular, the partition board matched with the shape of the edge of the area can be designed, and the partition board is fixed in the mold to realize the partition.

S13, a second model space of the next zone of the at least two corresponding zones is formed in the die in a separated mode, the second model space is connected with the corresponding edge of the first part, a second part with corresponding hardness is manufactured through the second model space, and the second part and the first part are connected into a whole in a butt joint mode;

Several specific examples of making the diaphragm are given below.

Example 1

Main extruder (A),55mm single screw diaphragm extruder, Lubrizol Isoplast 2530 polyurethane, Rockwell Hardness R Scale 121. And a secondary extruder (B) and a 55mm single-screw membrane extruder, wherein Lubrizol Pellethane 2363 polyurethane with the hardness of 55D is selected, and a coextrusion method is used for manufacturing the double-composition membrane. Specific parameters are shown in table 1:

table 1 shows the preparation parameter configuration of example 1.

Example 2

A main extruder (A), a 55mm single-screw membrane extruder, Lubrizol Isoplast 2530 polyurethane with Rockwell Hardness R Scale 121; and a secondary extruder (B) and a 55mm single-screw membrane extruder, wherein Lubrizol Pellethane 2363 polyurethane with Shore hardness of 65D is selected, and a co-extrusion method is used for manufacturing the double-composition membrane. Specific parameters are shown in table 2:

table 2 shows the preparation parameter configuration of example 2.

Example 3

A main extruder (A), a 55mm single-screw membrane extruder, Lubrizol Isoplast 2530 polyurethane with Rockwell Hardness R Scale 121; and a secondary extruder (B) and a 55mm single-screw membrane extruder, wherein Lubrizol Pellethane 2363 polyurethane with Shore hardness of 75D is selected, and a co-extrusion method is used for manufacturing the double-composition membrane. Specific parameters are shown in table 3:

table 3 shows the preparation parameter configuration of example 3.

Example 4

Main extruder (A),55mm single screw diaphragm extruder, Lubrizol Isoplast 2530 polyurethane, Rockwell Hardness R Scale 121. The auxiliary extruder (B) and a 55mm single-screw membrane extruder are made into a double-component membrane by a coextrusion method by selecting Lubrizol Pellethane 2363 polyurethane with the hardness of 53D. Specific parameters are shown in table 4:

table 4 shows the preparation parameter configuration of example 4.

Example 5

Main extruder (A),55mm single screw diaphragm extruder, Lubrizol Isoplast 2530 polyurethane, Rockwell Hardness R Scale 121. And a secondary extruder (B), a 55mm single-screw membrane extruder, wherein Lubrizol Pellethane 2363 polyurethane with the hardness of 62D is selected, and a coextrusion method is used for manufacturing the double-composition membrane. Specific parameters are shown in table 5:

table 5 shows the preparation parameter configuration of example 5.

Example 6

Main extruder (A),55mm single screw diaphragm extruder, Lubrizol Isoplast 2530 polyurethane, Rockwell Hardness R Scale 121. The secondary extruder (B), a 55mm single screw diaphragm extruder, selected CHIMEI PC-115P, Hardness: Ball industry Hardness110, was used for making a two-component diaphragm using a coextrusion process. Specific parameters are shown in table 6:

table 6 shows the preparation parameter configuration of example 6.

Example 7

Main extruder (A),55mm single screw diaphragm extruder, Lubrizol Isoplast 2530 polyurethane, Rockwell Hardness R Scale 121. The secondary extruder (B), a 55mm single screw diaphragm extruder, selected Eastar Copolyester 6763, Rockwell Hardness R Scale 106, using a coextrusion process for making a two component diaphragm. Specific parameters are shown in table 7:

table 7 shows the preparation parameter configuration of example 7.

Example 8

An injection molding machine, an Edex ATOR turntable bijective injection molding machine, selecting Lubrizol Isoplast 2530 polyurethane, Rockwell Hardness R Scale 121; the Lubrizol Tecothane TT-1055D polyurethane has Shore hardness of Shore 54D, and is subjected to double-component membrane injection molding by using a cold-sprue double-color mold. Specific parameters are shown in table 8:

table 8 shows the preparation parameter configuration of example 8.

While the present invention has been described in detail and with reference to the embodiments thereof as illustrated in the accompanying drawings, it will be apparent to one skilled in the art that various changes and modifications can be made therein. Therefore, certain details of the embodiments are not to be interpreted as limiting, and the scope of the invention is to be determined by the appended claims.

Claims

1. A diaphragm for making a mouthpiece comprising a body, the body comprising at least two portions in abutting engagement, the at least two portions having different hardnesses.

2. The film for forming a mouthpiece of claim 1 wherein one of said at least two portions is located inside the remaining portion; or

3. The film for forming a mouthpiece of claim 1 wherein said at least two portions are of uniform thickness.

4. The membrane for forming a mouthpiece of claim 1 wherein said at least two portions are of different or the same material.

5. The film for making a mouthpiece according to claim 1, wherein the sheet is a foamed material having uniformly distributed cells therein, and the cells are non-closed.

6. The film for making a mouthpiece of claim 1 wherein said sheet comprises at least two sheets, said at least two sheets having a differential stiffness therebetween.

7. A mouthpiece, characterized in that it is made from a membrane as claimed in any of claims 1 to 6.

8. A method of making a mouthpiece using a membrane as claimed in any one of claims 1 to 6, comprising the steps of:

9. The method of claim 8, further comprising:

10. The method of claim 8, wherein the step of forming the diaphragm according to a dental appliance protocol comprises: