WO2019172884A1

WO2019172884A1 - Heat moldable material

Info

Publication number: WO2019172884A1
Application number: PCT/US2018/021026
Authority: WO
Inventors: Lindsey E. OTERO; Misael J. OTERO
Original assignee: Otero Lindsey E; Otero Misael J
Priority date: 2018-03-06
Filing date: 2018-03-06
Publication date: 2019-09-12

Abstract

A method includes producing -a heat moldable substance by providing a biocompatible polymer material and adding a plasticizer or a food additive to the biocompatible polymer material. Processes may include providing an acrylic material and pelletizing the acrylic material The combination produces a substance that is moldable with heat and that becomes rigid when cooled.

Description

HEAT MOLBABLE MATERIAL

L CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application Is a continuation in part application and claims priority from PCT/DS! 6/36270, which claims priority from ITS. Provisional Patent Application No. 62/042,048, fried on August 13, 2015; ITS. Provisional Patent Application No

62/213106, filed on September 2, 2015; ITS. Provisional: Patent Application No.

62/238955, filed on November 28. 2015, and U.S. Provisional Patent Application No. 62/302195, filed on March 2_» 2016. which are incorporated herein by reference In their entireties.

If. FIELD OF THE- DISCLOSURE

[0002] The present disclosure relates generally to fomiaMe materials and processes for making the same.

III. BACKGROUND

[0003] Dentures are removable plates or frames that hold artificial teeth. Denture

manufacturing Is conventionally driven by a dentist for an individual -patient The dentist works in concert with a laboratory to have individually manufactured teeth pressed in to wax, which ½ melted out and replaced with resin, The patient is typically fit multiple times with the denture. Each fitting can involve sending the denture back to the laboratory for additional adjustment.

[0004] While effective at restoring a patient’s ability to chew and smile confidently, the denture manufacturing process can be expensive and time consuming. For those with limited financial means or access to oral care professionals, the expense and complex process can impede the potential benefits of dentures, lastly, there are individuals who do not visit .the dentist

IV. S UMMARY OF THE DI SCLOSURE

[0005] According to an embodiment, a .method includes producing a heal moldable

substance by providing a bidcompatible polymer material and adding a plasticizer or a food additive to the biocompafible polymer ttiaterial. The combination produces a substance that is raoldahie with heat and that becomes rigid when cooled.

According to a specific embodiment the plasticizer Is a .food additive. The acrylic material may be denture repair material. The acrylic material may include poly (methyl methacrylate) (PMMA) acrylic resin. The acrylic material may include ethylene vinyl acetate (EVA) copolymer rests material.

[0015] According to a particular embodiment, the substance has an approximate

durometer of 15 Shore A to 40 Shore A when heated. The substance may have an approximate dummeter of 60 Shore A to 90 Shore A when cooled. The substance may include.1 to 20 percent plasticizer by weight or volume.

According to specific implementation, the substance ½ waterproof at room temperature. Heat may he provided to the substance by: .a fee, a torch, electric heat, gas heat, hot water, hot oil a heated blanket, or a hair dryer, among other heat sources. The substance may be shaped by hand after heating.

1B a specific application, the substance Is used In a splint or cast, The substance may be used in a denture or footwear, such as a sandal or an insert. The substance may be used in a cup or a helmet The substance may be biocompatible.

[00101 Heat applied to the substance may range between 140 - 249 degrees Fahrenheit.

After cooling, the substance may fee reheated and. reshaped.

[0011] According to a particular embodiment a method of producing a heat moklable substance includes providing an acrylic material -and pelletizing die acrylic material. The pelletized acrylic material Is used to form a heat moldshie substance.

Features and other benefits Sat characterize embodiments are set forth in the claims annexed hereto and forming a bather part hereof. However, for a better understanding of the embodiments, and of the advantages and. objectives attained- through their use, reference should fee made to the Drawings and to the accompanying descriptive matter.

V. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] FIG. I show a perspective view of an em½d½es$ of a universal fit. boiEand- bite, lower denture:

[0014] FIG, 2 shows a sheet of material before being heated and molded: [0015] FIG^·. 3 shows a cup being Termed by hand from an embodiment of the material;

[0016] FIG. 4 shows a splint being formed by hand _.from an embodiment of the material; and

[0017] FIG. 5 is a flowchart ouflinisg an embodiment of a method of manofactaring heat moldable material using infection -molding processes.

Vi . DETAILED DESCRIPTION

[0018] An embodiment of moldable material includes a thermoplastic resin with a low enough melting point to be molded with heat and shaped to make custom products that are safe and easy to use. Once heated, the material may be molded into nearly any shape and cooled to harden in that shape. The moldable material may be shaped and repeatedly reshaped using a heat source, such as over a Ere, a torch, hot water, hot oil, a heated blanket, a hair dryer, etc. The moMahle material may be cut to different shapes with scissors or a heat pen before or after heating.

[0019] The rooidable materiai/resin may be injection molded, poured into molds, etc. to form a desired shape. For instance, the moldable material may be manufactured into a specific shape (like a denture) or in sheets and spheres of different sizes. The moldable material may be made harder or softer depending on the concentrations of materials mixed. The moldable material may be made 60 mold at temperatures ranging from very low to very high (e.g., relative to polymers) depending on the concentrations of materials mixed. The moldable material may be used in applications where it touches skin since all materials may be FD A approved. The moldable material may be bonded to other materials, such as hard acrylic, soil acrylic, plastic, or EYA, among other materials, which may allow for a soft lining or firm pieces to be added.

[0020] The moldable material may be used for dentures, partial dentures, nightguards, retainers, and sleep devices for the mouth. The moldable material may be used as a splint or cast utilized_: by physicians in an emergency room, Generally, when a bone is broken, it is. set first and a cast is applied a day or two later. The moldable material may he used to set or east in a manner that may be easily removed with heat. The moldable material may be used as a splint or east in the field, by EMT/paramedies, travelers, and the military. [0021] The moldable material is lightweight and may be added to a backpack -or first aid kit. The moldable material may be used for heat moldable sandals. Such sandals may be used particularly in countries or areas where shoes are not easily available, A sheet of the moldable material may be carried as a backup pair of shoes while hiking.

[0022] The moldable material may be used in. podiatrist offices or sold over-ihe<xmnter as shoe inserts or orihoties The -material may be positioned as an Insole in shoes or sandals hi such a scenario, the moldable material may be heated and stepped on by a foot, cooled and placed into the bed of the sandal. In this manner, a custom fit of a loot may be achieved.

[0023] An embodiment of the material is waterproof, A. sheet or other allotment of the material may be included in first aid kite. and military packs.- The field applications- of the moldable material may include helmet repair, boot repair, mid use as a splint, as well as to make- a cup to collect water. A single piece of moldable material may be used .tor a cup one day and reheated to males a splint eti another. The moldable material may be reheated repeatedly and reused tor different functions as often as needed.

[0024] According to a particular embodiment, a biocompatible polymer material is

combined with a plasticizer or a food additive. The bioeompatiMe polymer material may include a material that has been approved for hiocompatihility (e.g., nondazardous interlace compatible with living tissue). The bioeompalibility may allow it to be used in conjunction with a living animal (e.g., in a mouth). The combination may produce a substance that is moldable with heat and that becomes rigid when cooled.

[0025] .An embodiment of a method adds a plasticizer or -a food additive to denture repair material Examples of plasticizers and food additives include: triethyl citrate, tributyi citrate, and tributyi acetylcitrate, among others. Plasticizers are additives that increase t¾e plasticity oriluidliy of a material. Illustrative denture repair material may include methyl methacrylates and poly methyl methacrylates, among others. The combined substance is. bendable to other material and holds with mechanical retention when heated. The material may have an approximate durometer of IS shore A to 40 shore -A when heated. The combined substance may have an approximate durometer of 60 Shore A to 90 Shore A when cooled. The hardness may enable a denture, for Instance, to maintain Its shape despite a bite force. As such, the material may be solid when cooled and flexible (e g., like leather), when cooled. Each of the _.combined .material_., additive, and/or plasticizer may be color stable.

[0026] The additive may be mixed with the .denture repair materia! at different ratios to make the combined material moldable According to an embodimeBt, the material comprises I to 20 percent plasticizer by weight or volume. The ratio of plasticizer to acrylic may be varied to achieve higlier/lower melting points, as well as varying degrees of hardness depending upon a desired application. The moldability of the combined material may increase proportionally to the amount of plasticizer added. Virtually any PMMA with or without plasticizer may be manufactured with thenncset or injection molding.

[0027] In an implementation, material may be used to patch other material. For Instance, the ratio of EVA may be adjusted so that when heated, the patching material may be sticky or goopy in consistency. Once applied and cooled, the material may combine or otherwise attach to a surface to form the repair.

[0028] According to an illustrative method, the combined material is- permitted to set up.

For example_* the combined /material may initially have a gelatin consistency and may become hard in approximately five- minutes, in an example, the hardened material may be pelletized and used in a layered manufacturing process, such as injection molding or three-dimensional (3-D) printing. Pelletizing of an embodiment may result in bead sized pellets to reduce waste. According to another embodiment mixed material may he poured while in liquid .form into a mold to taken desired shape.

[0029] After the material sets up, the hardened material may be heated and reshaped by hand. For example, the material may be heated by hot water or a chemical heat pack.

The size of the material may not change, but the shape of the material may be changed. For instance, the heated material may be folded and bent. The heated material may further be cut Once hardened the material may be stiff and unable to be folded, bent, or cut, among other changes,

[6030] In one implementation, the mixed material may be poured into and sold in sheets to be heated and formed by hand or .machine. For instance, a sheet may be formed into a splint, cast, cup, or sandal As such, uses may include military and emergency applications. In another example, the material may be sold as spheres that may be heated and formed.. For instance, the spheres may he formed into ear plugs or customizable ear buds.

[0031] An embodiment may include a boil and bite impression tray. The implementation avoids having to mix a base _.and a catalyst. User may hare multiple attempts (e.g.. by reheating) to make impressions for to make prosthetic devices such as dentures, crowns, orthodontic aligners, .braces, .retainers, and partial dentures A tray may be preloaded and positioned in boiling water. The impression tray _.and material soften so that a. user may place the impression tray in their mouth. Hard and soft tissues may he captured in the impression material. The tray and the impression can then be used to fabricate the prosthesis of choice. The tray may be constructed from flexible material, such as poiy(methyl methacrylate) (PMMA)

[0832] As with other embodiments, the impression material may include a thermoplastic elastomer (e.g., EVA or Polyolefin or blends of similar materials). Additional layers of elastomers at different durometers may be included in other embodiments. The impression material may be preloaded in the impression tray to avoid preparation by a user.

[0833] The more plasticizer that Is used, the softer the resultant material may be and the lower its melting point For example, a combination of one percent plasticizer may result in a material that is relatively stiff while heated. Material with twenty percent plasticizer may remain bondab!e and relatively fbrmabie while heated,

[0034] In a specific implementation comprising a denture, a poly (methyl methacrylate) (PMMA) acrylic resin Is combined with plasticizer to become thermoplastic. When boiled in water, the denture molds and flexes to take most month shapes. The

composition may become harder in a patient^'s mouth or cool water in am and one to two ten minutes and will maintain its shape. Where desired, the denture may be re-healed to take another shape or to adjust to changes In a palate over time. The Injection molding processes enables -cost efficient mass prod uction.

[0035] The denture material may include poly (methyl methacrylate) (PMMA) acrylic resin, aft acrylic material a plasticizer, and/or ethylene vinyl acetate (EVA) copolymer resin material, among other materials. Embodiments melude an acrylic that ½ injection mold-able, butafter curing and hardening, the acrylic material can he shaped and formed by applying minimal heat, e.g,, between 140 - 240 degrees Fahrenheit hi a specific example, deformation of the denture begins at aro und I SO degrees Fahrenheit and becomes completely malleable when exposed to 220 degrees Fahrenheit for 30 seconds. The temperature of the denture may not increase beyond a malleable threshold in a manner analogous to a phase change boiling point

[0036] Once cooled, the acrylic material retains its shape in the hardened i½m Custom fonnable dentures may accommodate wide ranges of mouth dimensions, Once cured, the molded denture retains its shape. The users can also reshape the denture at inter point in time, if desired. The material may also be sold as sheets or ½ oilier forms that can be bent to apply structural supports for various applications such as splints, more durable mouth guards, sleep apnea devices, retainers, etc.

[0837] In practice, the dentures may allow a user to base one to five ten minutes of

Working time after boiling to shape the dentures to their mouth. After boiling, dentures may take up to about five minutes to set According to an implementation, enough material. may be included as to allow die users to trim any excess material on the gum line, depending on: how .much they need to fit properly and comfortably.

[0038] When heated, the denture may have an approximate dnrometer of 15 Shore A to 40 Shore A. When cooled, a: portion (e.g,, a teeth layer) may have an approximate durometer of 60 Shore D to 90 Shore D, Another portion_. may include a gingival layer of molded pink acry lic having an approximate dnrometer of 60 Shore D to 90 Shore D. A iner layer may he made from thermoplastic, PMMA, EVA, and acry lic, among other heat moldable and non-heat moMahle materials, including those having a cushioning qualities.

[0039] The material of an embodiment may be made in varying hardness depending on the exact concentrations of ingredients. For _.example, the material may be made soil to be put against skin or hard if a more durable material is needed for the specific

application. The material may be a single hardness all the way through or may be made· with layers of varying hardness.. For _.example, the different concen.trations/raiios of the ingredients may comprise a hard tooth and gingival layer with a soft liner - all the same material but with different ratios. The material may be layered with other material through chemical or mechanical bonding. [0040] FIG. 1 shows a perspective view of a universal fit, boil-and-bite, lower denture 100. The deatore 100 of the same or another embodiment may fee manufactured using injection molding processes The material may fee pliable when: heated, as the gingival portion flexes to fit shape and angles of the user’s month. The denture 100 includes a gingival layer 102 and teeth 1(14.

Out of the box, the denture 100 of _.an embodiment Is hard like standard dentures* but once submerged in boiling water for around 30 to 120 seconds, the denture. 100. becomes flexible to form to the user’s mouth. After about 1-10 minutes of setting with or without submerging in cool water, the denture maintains its shape and hardens. If at some point later on the user desires to refit the denture 100, they can. easily re-boil the dentures and form to their mouth again. The denture 1.00 may be used alone or in combination with an upper denture.

[0942] FIG. 2 illustrates a -sheet 202 of material prior to be heated and molded by hand.

White a shee t 202 of the material is illustrated, or other prepackaged shapes of the material. may sold, stored, transported and heated as described_·

[0043] FIG. 3 illustrates material being molded by hand into a cup shape 302. The

material may harden into the cup shape: when cooled. Alter use, the cup shaped material 302 may be reheated and repurposed

[0044] FIG. 4 shows material that has been molded fey hand into a splin t 402 to set as injured appendage. As described above, a sheet or other shape of the material may be heated and formed in the shape of the splint. The material may harden into the splint shape when cooled. After use, the splint shaped material may be reheated and

repurposed.

[9945] FIG. 5 is a flowchart outlining an embodiment of a method 500 of manufacturing a denture using injection molding processes. The denture may be created through injection molding with overm.oiding to create layers that comprising the denture.

[0046] During manufacture by injection molding, a powder and liquid are mixed in ratio at 502. The mixture may include a plasticizer. The mixture hardens and is pelletized at 504. The pellets are put into an injection molding machine at 506.

[0947] The material may be packaged at 508 according to a specific or general purpose A -user may heat the material at 510 to form it into a. desired shape at 512, For example, the material may be heated by a hair dryer, hoi water, or a chemical heat pack. Alter the material sets isp, the hardened material may be shaped by hand (e.g_, folded best or cut⁾. Once .hardened, the material may be rigid and stiff. The .material may be reshaped at 514 with heating, hi this manner, the material may be adjusted, tensed and even repurposed after multiple_. uses.

[0048] The pre vious description of the disclosed embodiments is provided to enable any person skilled in the art_. to make or use the disclosed embodiments. Various

modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without .departing from the scope of the disclosure. For example, while some embodiments of the third: layer may include E VA, other layers may be used. In one application, a first layer includes molded teeth, and the second layer includes a gingival colored skeleton structure that holds and supports a softer, low density elastomer (e.g„ layer three). This third layer may be responsible to stretch and deform and squish to fit the oral cavity. Other materials comprising the third layer would be a -polyolefin elastomer, a polypropylene, and also an ethylene. Thus, the third.layer may be any elastomer with excellent flow characteristics and toughness. Thus, the present disclosure is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope possible consistent with the principles and features as defined by the following claims.

Claims

1. A method of producing a heat moldahle substance, the method comprising;

providing a Mocompatihle polymer material; and

adding a plasticizer or a food additive to the biocompatihle polymer material, wherein the combination produces a substance that is moldable with heat and that becomes rigid when cooled.

2. The method of claim 1 , wherein the plasticizer is a food additi ve.

3. The method of claim 1, -wherein the acrylic material is denture repair material.

4. The method of claim 1 , wherein the -acrylic material includes poly (methyl methacrylate.) (PMMA) acrylic resin.

5 The method of claim 1 , wherein the -acrylic material includes ethylene vinyl acetate (EVA) copolymer resin material

6. The method of claim. 1, wherein the substance has an approximate dnrometer of 15 Shore A to 40 Shore A when heated.

7. The method of claim 1 wherein tire substance has an approximate dummeter of 60 Shore A to 90 Shore A when cooled.

8 The method of claim 1, w herein the substance comprises 1 to 20 percent plasticizer by weight or volume.

9. The method of claim 1 , wherein the substance is waterproof at room temperature .

10. The method of claim 1 , wherein the heat is provided by at least one of: a fire, a torch, electric heat, gas heat hot water, hot oil, a heated blanket, and a _.hair dryer, among oilier heat sources.

1 1. The method of claim i, wherein the substance is shaped by hand after heating.

12 The method of claim 1, wherein the substance is used in at least one of a splint and cast.

13. The method of claim 1 , wherein the substance Is used in a denture.

14. The method of claim I, wherein the substance is used in footwear.

15. The method of elmm 1, wherein the substance is used m at least one of a cup and helmet.

16. The method of claim 1, wherein the substance is biocompatible.

17. The method of claim 1 , feather comprising applying the beat to the substance in a range between 140 - 240 degrees Fahrenheit.

IS. The method of claim 1, further comprising reheating and reshaping the substance.

19. A method of producing a heat moldable substance_» the method comprising: providing an acrylic material;

pelletizing the acrylic maiehal; and

heating the pelletized acrylic material to form a heal moldable substance. 20 A method of using a heat moidabie substance, the method comprising: heating a denture, the denture comprising:

a tooth layer comprising teeth that have been formed by injection molding or thiee-dimensiiinal printing; and

a top layer comprising an elastomer;

forming the denture $o a contour of a, users month while in the mouth of

1½ user: and

allowing the denture to cool without ftuther modification prior to use as a denture-