US20220040004A1 - Method and apparatus for correcting auricular deformities - Google Patents
Method and apparatus for correcting auricular deformities Download PDFInfo
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- US20220040004A1 US20220040004A1 US17/510,164 US202117510164A US2022040004A1 US 20220040004 A1 US20220040004 A1 US 20220040004A1 US 202117510164 A US202117510164 A US 202117510164A US 2022040004 A1 US2022040004 A1 US 2022040004A1
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- 238000000034 method Methods 0.000 title claims description 22
- 239000000758 substrate Substances 0.000 claims abstract description 139
- 239000000463 material Substances 0.000 claims abstract description 99
- 230000002500 effect on skin Effects 0.000 claims abstract description 57
- 239000011800 void material Substances 0.000 claims abstract description 13
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 239000000853 adhesive Substances 0.000 abstract description 17
- 230000001070 adhesive effect Effects 0.000 abstract description 17
- 239000011159 matrix material Substances 0.000 description 7
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- 210000001519 tissue Anatomy 0.000 description 3
- 230000002159 abnormal effect Effects 0.000 description 2
- 230000005856 abnormality Effects 0.000 description 2
- 230000004075 alteration Effects 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 210000004728 ear cartilage Anatomy 0.000 description 2
- 210000000883 ear external Anatomy 0.000 description 2
- 229940011871 estrogen Drugs 0.000 description 2
- 239000000262 estrogen Substances 0.000 description 2
- 241000746998 Tragus Species 0.000 description 1
- 210000000845 cartilage Anatomy 0.000 description 1
- 230000001010 compromised effect Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 210000000613 ear canal Anatomy 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 239000000806 elastomer Substances 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 230000000977 initiatory effect Effects 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 210000004373 mandible Anatomy 0.000 description 1
- 210000001595 mastoid Anatomy 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
- A61F11/06—Protective devices for the ears
- A61F11/14—Protective devices for the ears external, e.g. earcaps or earmuffs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
-
- A61F11/004—
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
- A61F11/06—Protective devices for the ears
- A61F11/08—Protective devices for the ears internal, e.g. earplugs
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F11/00—Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
- A61F11/20—Ear surgery
Definitions
- FIG. 3D is a perspective view of one of the auxiliary ear support structure illustrated in FIG. 3A , shown configured as a retractor sized differently with respect to the retractor illustrated in FIG. 3C ;
- FIG. 3E is a perspective view of the ear support structure illustrated in FIG. 3D , shown attached to a substrate;
- the auricular support system 20 constructed in accordance with one embodiment can include at least one substrate 27 that is configured to attach to a dermal surface 26 that is disposed adjacent the auricle 24 , and a mold material 30 , such as a gel, that is configured to be applied in a gelatinous state to the auricle 24 and the at least one substrate 27 .
- the mold material 30 can then be allowed to cure, such that the mold material 30 attaches to both the auricle 24 and the substrate 27 , thereby supporting the auricle 24 relative to the substrate 27 .
- a mold material 30 such as a gel
- the mold material 30 when the mold material 30 is applied to the auricular structure 22 and the second end 56 b of the substrate body 56 , the mold material can become disposed in the void 59 and mold about the auricular structure 22 .
- the mold material 30 cures after the mold material 30 is applied to the auricular structure 22 and the substrate body 56 , the mold material 30 supports the auricular structure 22 relative to the substrate 28 .
- the first end 56 a of the substrate body 56 can be attached to the dermal surface 26 , and the auricular structure 22 can be manipulated as desired so as to correct a deformity of the auricular structure 22 .
- the second splint 87 can be constructed as described above with respect to the first splint 82 , with the exception that the splint body 84 can be sized and shaped differently than the splint body 84 of the first splint 82 .
- the splint body 84 can be sized and shaped differently than the splint body 84 of the first splint 82 .
- at least one or more up to all of the first and second surfaces 85 and 87 , including the first region 85 c of the first surface 85 , of the second splint 87 can be sized and shaped differently than those of the first splint 82 .
- the gap 88 of the second splint 87 can be sized and shaped differently than the gap 88 of the first splint 82 .
- the gap 88 of the second splint 87 can be sized to receive the helical rim 32 at the cranial end of the auricle, and the first region 85 c of the first surface of the second splint 87 can be configured to face or abut one or both of the triangular fossa 34 and the helical crux 35 (see FIG. 1A ).
- gap 88 of the second splint 87 has been described as sized to receive the helical rim 32 , it should be appreciated that the gap 88 can alternatively receive the lobule 46 , so as to correct for a lobular defect as desired.
- the second end surface 86 b can face the second substrate 31 . Accordingly, at least one or more portions of the at least one substrate 27 can be attached to the second end surface 86 b .
- the adhesive 58 and thus the first end 56 a , can be attached to the second end surface 86 b , such that the second end 56 b , and thus the fingers 62 , face the second substrate 31 .
- the at least one void 59 such as a plurality of voids that are configured to receive the mold material 30 can be defined by the second end 56 b of the second region 33 b alone or in combination with the first region 33 a .
- the second region 33 b alone or in combination with the first region, can define the matrix that defines the plurality of voids 59 .
- the first end 56 a of the second region 33 b alone or in combination with the first region 33 a can define the first surface 60 a and the opposed second surface 60 b that is spaced from the first surface along 60 a along the transverse direction T.
- the mold material 30 can cure so as to attach the mold material to the second region 33 b alone or in combination with the first region 30 a in the manner described above.
- the second substrate 31 along with any additional substrates of the auricular support system 20 , can include the first and second regions 33 a and 33 b in accordance with any embodiment as described herein.
- the first and second substrates 28 and 31 , or any other substrate of the auricular support system 20 can be constructed in accordance with any suitable alternative embodiment so as to be attachable to the dermal surface 26 and define at least one void 59 such as a plurality of voids 59 that are suitable to receive the mold material 30 , such that the mold material 30 is attached to the substrate when the mold material 30 is cured.
- the body of the at least one substrate 27 can define a sponge matrix that defines the voids 59 .
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Otolaryngology (AREA)
- Physics & Mathematics (AREA)
- Acoustics & Sound (AREA)
- Biophysics (AREA)
- Psychology (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Surgery (AREA)
- Orthopedics, Nursing, And Contraception (AREA)
- Prostheses (AREA)
- Moulds For Moulding Plastics Or The Like (AREA)
Abstract
An auricular support system can include a substrate and a mold material. The substrate can include a substrate body having a first end and an opposed second end. At least a portion of the first end can be configured to carry an adhesive suitable to attach to a dermal surface. The second end defines at least one void. The mold material can be configured to be applied to both an auricular structure and the second end of the substrate body such that the mold material becomes disposed in the void and molds about the auricular structure. The mold material can be configured to cure after the mold material is applied to the auricular structure and the substrate body so as to support the auricular structure relative to the substrate. The auricular support system can further include an auxiliary support structure configured to attach to the auricular structure, such that the mold material is further configured to be applied to the auxiliary support structure so as to support the at least one auxiliary support structure relative to the substrate, and thus the dermal surface.
Description
- This application is a continuation of U.S. application Ser. No. 14/758,877, filed Jul. 1, 2015, which is the United States national phase entry of International Application No. PCT/US2014/010102, filed Jan. 2, 2014, and claims the benefit of U.S. Provisional Application No. 61/748,240, filed Jan. 2, 2013. The contents of U.S. application Ser. No. 14/758,877, International Application No. PCT/US2014/010102, and U.S. Provisional Application No. 61/748,240 are hereby incorporated by reference as if set forth in their entireties herein.
- A significant number of infants are born with some form of auricular deformity. Further, infants born without an auricular deformity can cause damage to the ear in the hours and days after birth, for instance due to contact with a mattress, a car seat, or the like. Examples of auricular deformities in newborn infants include conditions that result from a lack of auricular tissue, an excess of auricular tissue, and incorrectly shaped auricular tissue.
- It has been found that increased levels of estrogen present in newborn infants produce advantageous pliable effects in auricular cartilage. As a result, if the ear is placed and held in a desired anatomic position early in life, the ear will be molded into a more natural shape and fixed over a brief period of time. As the infant ages, the levels of estrogen decrease, which causes the cartilage to becomes less malleable and more rigid. The reduced malleability and increased rigidity of the ear cartilage reduces the ability to reposition auricular deformities. For instance, it has been found that success rates of attempts to alter anatomical aspects of the ear after 3 weeks of life can decrease by more than 50% with respect to initiating such attempts before the expiration of 3 weeks of life.
- Ear repositioning systems currently exist that include fixation devices designed to address auricular deformities in newborn infants. However, such systems can rely upon double-sided tape to attach to both the skin surface and the fixation devices. However, the adhesion of the tape to the skin surface can become compromised, which causes maintenance of the fixation devices to be labor intensive. In some instances, the fixation devices and tape are administered by guardians of the infant at home, which can result in improper application of the fixation devices. Some conventional systems include an ear well is adhesively attached, for instance via double-sided tape, to the cranial skin surface that surrounds the ear. The ear well thus surrounds the ear and supports auxiliary structure that attaches to various portions of the ear so as to maintain the ear portions in a desired position. However, the ear well does not provide much positional flexibility of the auxiliary structure. Furthermore, the adhesion of the ear well to the outer skin surface can degrade, for instance at the mastoid region due to movement of the mandible during normal anatomical operations. Still other conventional ear positioning systems comprise various splints and other fixation devices created by clinicians on a case-by-case basis.
- In accordance with one embodiment, an auricular support system can include a substrate and a mold material. The substrate can include a substrate body having a first end and an opposed second end. At least a portion of the first end can be configured to carry an adhesive suitable to attach to a dermal surface. The second end defines at least one void. The mold material can be configured to be applied to both an auricular structure and the second end of the substrate body such that the mold material becomes disposed in the void and molds about the auricular structure. The mold material can be configured to cure after the mold material is applied to the auricular structure and the substrate body so as to support the auricular structure relative to the substrate.
- The foregoing summary, as well as the following detailed description of an example embodiment of the application, will be better understood when read in conjunction with the appended drawings, in which there is shown in the drawings an example embodiment for the purposes of illustration. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings:
-
FIG. 1A is a perspective view of an auricular support system including a mold material and a substrate configured to attach to a dermal surface, showing the substrate attached to a dermal surface adjacent an auricle; -
FIG. 1B is a perspective view of the auricular support system, showing the mold applied to the auricle and the substrate; -
FIG. 2A is a perspective view of a mold material disposed in a dispenser; -
FIG. 2B is a perspective view of a first substrate; -
FIG. 2C is a perspective view of a second substrate; -
FIG. 2D is a sectional side elevation view of a portion of the second substrate illustrated inFIG. 2C , taken along line 2D-2D; -
FIG. 3A is a schematic perspective view of the auricular support system illustrated inFIG. 1A , further including auxiliary ear support structure; -
FIG. 3B is a perspective view of one of the auxiliary ear support structure illustrated inFIG. 3A , shown configured as a conchal cavity former; -
FIG. 3C is a perspective view of one of the auxiliary ear support structure illustrated inFIG. 3A , shown configured as a retractor; -
FIG. 3D is a perspective view of one of the auxiliary ear support structure illustrated inFIG. 3A , shown configured as a retractor sized differently with respect to the retractor illustrated inFIG. 3C ; -
FIG. 3E is a perspective view of the ear support structure illustrated inFIG. 3D , shown attached to a substrate; -
FIG. 4A is a sectional side elevation view of a substrate similar to the substrate illustrated inFIGS. 2B-C , but constructed in accordance with an alternative embodiment; -
FIG. 4B is a front elevation view of the substrate illustratedFIG. 4A , but shown attached to a dermal surface adjacent an auricle; -
FIG. 4C is a perspective view of the substrate illustratedFIG. 4A , shown attached to the dermal surface adjacent an auricle illustrated inFIG. 4B ; and -
FIG. 4D is a perspective view of a substrate constructed in accordance with another alternative embodiment. - Referring to
FIG. 1A , anauricular support system 20 is configured to support variousauricular structure 22, for instance of anauricle 24, relative to adermal surface 26 of the cranium that is disposed adjacent theauricle 24, for instance medial with respect to the auricle, such that theauricular structure 22 is maintained at a position that is spaced from thedermal surface 26 at a desired distance. Theauricular support system 20 can be further configured to maintain theauricular structure 22 in a desired shape, so as to correct for a deformity in a newborn infant. - Referring to
FIG. 1A , theauricular support system 20 constructed in accordance with one embodiment can include at least onesubstrate 27 that is configured to attach to adermal surface 26 that is disposed adjacent theauricle 24, and amold material 30, such as a gel, that is configured to be applied in a gelatinous state to theauricle 24 and the at least onesubstrate 27. Themold material 30 can then be allowed to cure, such that themold material 30 attaches to both theauricle 24 and thesubstrate 27, thereby supporting theauricle 24 relative to thesubstrate 27. For instance, referring also toFIG. 1B , themold material 30 is configured to mold about an auricular structure of theauricle 24, including at least one or more, up to all of thehelical rim 32, thetriangular fossa 34, thehelical crux 35, theantihelix 36, theconcha 38, thetragus 40, theantitragus 42, the externalauditory meatus 44, thelobule 46, and can further extend into theconchal cavity 48 and theear canal 50. Once the mold material has cured about the auricular structure of theauricle 24, mechanical interference between the auricular structure and the curedmold material 30 prevents inadvertent removal of the curedmold material 30 from theauricle 24. - As illustrated in
FIG. 2A , themold material 30 can be disposed in ahousing 52, which can be configured as dispenser, that defines anoutlet opening 54. In accordance with one embodiment, thehousing 52 can be configured as a tube. Thehousing 52 can be flexible, such that during operation an inwardly directed squeezing force causes thehousing 52 to deform, thereby inducing a positive internal pressure that forces a quantity of the mold material out theopening 54. It should be appreciated that thehousing 52 can be alternatively configured to dispense a quantity of themold material 30 as desired. Themold material 30 can be provided as any suitable biocompatible mold material that is suitable to be applied to theauricular structure 22 and thesubstrate 27 in a gelatinous state, and subsequently cured so as to at least partially surround a structure of theauricular structure 22 and thesubstrate 27, thereby resisting separation with respect to theauricular structure 22 and thesubstrate 27. It should thus be appreciated that themold material 30 can define a gel, which can be provided as a polymer. For instance, the gel can be an elastomer, such as silicone. It should be further appreciated that the gel can be a two-part pliable polymer, wherein first and second parts of the polymer mix so as to activate the polymer, such that the polymer can cure a short duration after being dispensed from thehousing 52. For instance, in accordance with one embodiment, the mold material can be a polymer sold under the federally registered trademarks MEMOSIL®, MEMOSIL® 2, or MEMOSIL® C.D. commercially available from Hareaus Kulzer, having a place of business in Armonk, N.Y. - Referring now to
FIG. 2B , the at least onesubstrate 27 can include asubstrate 28 that includes asubstrate body 56 having afirst end 56 a is configured to carry an adhesive 58 that is suitable to attach to thedermal surface 26, and asecond end 56 b opposite thefirst end 56 a. Thesecond end 56 b can define at least onevoid 59 such as a plurality ofvoids 59 that are configured to receive themold material 30 that is applied to thesubstrate 28. Thus, it should be appreciated that thesecond end 56 b of thesubstrate body 56 can include a matrix that defines thevoids 59. For instance, thefirst end 56 a can define afirst surface 60 a and an opposedsecond surface 60 b that is spaced from thefirst surface 60 a along a transverse direction T. At least a portion of thefirst surface 60 a is configured to carry the adhesive 58. Thesubstrate body 56, such as thesecond end 56 b of thesubstrate body 56, can further include a at least onefinger 62, such as a plurality offingers 62, that project out from at least a portion of thesecond surface 60 b. Thus, thesubstrate body 56, for instance at thesecond end 56 b, can define a matrix offingers 62 that project out from thesecond surface 60 b. Thefingers 62 can be configured as hooks, loops, or any suitable constructed alternative projection suitable for at least partially defining thevoids 59 that can receive the appliedmold material 30 so as to attach thefingers 62, and thus the substrate, to themold material 30 once themold material 30 has cured. Thus, it can be said that the matrix offingers 62 of thesubstrate body 56 can project from thesecond surface 60 b. In accordance with one embodiment, the at least onesubstrate 27 is commercially available under the trademark Velcro® from Velcro USA Inc, having a place of business in Manchester, N.H. - Thus, it should be appreciated that the fingers can extend out from the
second surface 60 b along both the transverse direction T and a direction perpendicular to the transverse direction T, such that the void 59 can be defined between thesecond surface 60 b of thefirst end 56 a and a portion of thesecond end 56 b, which can be defined by thefingers 62, along the transverse direction T. Thefirst end 56 a can extend generally along at least a first direction, such that thevoids 59 extend between therespective fingers 62 and thesecond surface 56 b. It should thus be appreciated that when themold material 30 is applied to theauricular structure 22 and thesecond end 56 b of thesubstrate body 56, the mold material can become disposed in the void 59 and mold about theauricular structure 22. Thus, when themold material 30 cures after themold material 30 is applied to theauricular structure 22 and thesubstrate body 56, themold material 30 supports theauricular structure 22 relative to thesubstrate 28. During operation, at least a portion of thefirst end 56 a of thesubstrate body 56 can be attached to thedermal surface 26, and theauricular structure 22 can be manipulated as desired so as to correct a deformity of theauricular structure 22. - For instance, the
auricular structure 22 can be stretched, compressed, bent, straightened, placed further from thedermal surface 26, or placed closer to thedermal surface 26, or can be alternatively manipulated as desired so as to correct the deformity. Themold material 30 can then be applied to the manipulatedauricular structure 22 and thesubstrate 28 and allowed to cure as described above, so as to maintain the manipulated configuration of theauricular structure 22. Once it is desired to remove theauricular support system 20, a free edge of the curedmold material 30 can be gripped and peeled away from, and thus removed from, theauricular structure 22. Thesubstrate 28 can be further removed from thedermal surface 26, thereby removing themold material 30 from thedermal surface 26. Alternatively or additionally, themold material 30 can be peeled away from, and thus removed from, thesubstrate 28, and thus removed from thedermal surface 26, before thesubstrate 28 is removed from thedermal surface 26. - Referring now also to
FIGS. 2C-2D , it should be appreciated that theauricular support system 20 can include as many substrates as desired. For instance, the at least onesubstrate 27 illustrated inFIG. 1A can include thesubstrate 28 illustrated inFIG. 2A , which can be provided as a first substrate, as well as asecond substrate 31 that can be constructed in any manner as described above with respect to thesubstrate 28. Thus, it should be appreciated that thesecond substrate 31 can be constructed substantially identically or differently with respect to thesubstrate 28. For instance, as described above, thefirst end 56 a can extend substantially in at least afirst direction 61 a. Thefirst end 56 a can further extend substantially in at least asecond direction 61 b that is angularly offset, such as perpendicular, with respect to thefirst direction 61 a. It should be understood that at least one or both of thefirst direction 61 a and thesecond direction 61 b can be substantially linear, curved, or undulating before or after application to thedermal surface 26. The transverse direction T can extend substantially perpendicular to one or both of the first or second directions 61 a-b. - The
second substrate 31 can be dimensioned differently, such as smaller or greater, than or the same as thesubstrate 28 in one or both of the first or second directions 61 a-b. Thesecond substrate 31 can further be shaped differently than or the same as thesubstrate 28. In accordance with the illustrated embodiment, thesecond substrate 31 is larger than thesubstrate 28 along both the first and second directions 61 a-b, and is sized to be attached to thedermal surface 26 at a location posterior of the outer ear, for instance at a location medially with respect to thehelical rim 32. Thesubstrate 28 is sized to be attached to thedermal surface 26 at a location cranially with respect to the outer ear, for instance at a location medially with respect to thehelical rim 32. It should be appreciated, of course, that eithersubstrate auricular support system 20, can be positioned anywhere as desired such that the mold material is configured to attach to both theauricular structure 22 and the substrates in the manner described above. - Referring now to
FIG. 3A , theauricular support system 20 can further include at least oneauxiliary support structure 70 that is configured to attach to a respective auricular structure. Thus, it should be appreciated that themold material 30 is configured to attach to a firstauricular structure 22, and theauxiliary support structure 70 is configured to attach to a second auricular structure, which can be the same as, included in, or different than, the firstauricular support structure 22. Themold material 30 is further configured to be applied to theauxiliary support structure 70 so as to support the at least oneauxiliary support structure 70 relative to thesubstrate 28. For instance, themold material 30 is configured to mold about at least a portion up to all of theauxiliary support structure 70 and subsequently cure to theauxiliary support structure 70 along with theauricular structure 22, and further attach to the at least onesubstrate 27 as described above. - Referring now to
FIGS. 3A-B , the at least oneauxiliary support structure 70 can include a conchal cavity former 71 that is sized and configured to be inserted into the conchal cavity 48 (seeFIG. 1A ). Thus, the conchal cavity former 71 includes a conchal cavityformer body 72 that can include a first auricle-facingsurface 72 a that is configured to face theauricle 24 when attached to theauricle 24, andsecond surface 72 b opposite thefirst surface 72 a. The conchal cavity former 71 can further include one ormore apertures 74 extending from thesecond surface 72 b toward thefirst surface 72 a. For instance, theapertures 74 can extend from thesecond surface 72 b through thefirst surface 72 a. Theapertures 74 are configured to receive themold material 30, such that themold material 30 can flow from thesecond surface 72 b toward, for instance to, thefirst surface 72 a so as to strengthen the attachment of themold material 30 to the conchal cavity former 71 when themold material 30 cures. The conchal cavityformer body 72 can define at least oneside surface 72 c that extends between the first andsecond surfaces 72 a-b. For instance, the at least oneside surface 72 c can include a firstcurved portion 76 that defines first and second opposed terminal ends 76 a-b, and a second substantiallylinear portion 78 that extends substantially linearly between the first and second terminal ends 76 a-b. It should be appreciated that the second substantiallylinear portion 78 can have a curvature (including a zero curvature) that is less than the curvature of the firstcurved portion 76. The at least oneside surface 72 c is thus contoured to conform to a healthy conchal cavity. It should be appreciated that theauricular support system 20 can include a plurality ofconchal cavity formers 72 having different sizes and shapes suitable to correspond to differently sized conchal cavities of different infants. - Thus, when the conchal cavity 48 (see
FIG. 1A ) has an anatomical abnormality, the conchal cavity former 71 having a desired size and shape that is different than the abnormal size and shape can be inserted into the abnormalconchal cavity 48, thereby causing theconchal cavity 48 to generally conform to the size and shape of the conchal cavity former 71. The attachment of themold material 30 to the conchal cavity former 71, theauricular structure 22, and the at least onesubstrate 27 retains the conchal cavity former 71 with respect to the at least onesubstrate 27, and thus also to thedermal surface 26. In this regard, reference to attachment of the mold material to thedermal surface 26 can further include attachment to the at least onesubstrate 27 that is, in turn, attached to thedermal surface 26. When themold material 30 is removed from theauricular structure 22 and thedermal surface 26, the attachment of themold material 30 to the conchal cavity former 71 can cause themold material 30 to remove the conchal cavity former 71 from theconchal cavity 48. Alternatively, themold material 30 can be removed from the conchal cavity former 71, and the conchal cavity former 71 can then be removed from theconchal cavity 48. - Referring to
FIG. 3A andFIGS. 3C-3D , the at least oneauxiliary support structure 70 can include at least onesplint 80, alone or in combination with the conchal cavity former 71. For instance, the at least onesplint 80 can include a plurality ofsplints 80, including afirst splint 82 and asecond splint 87 that are each configured to attach to respective auricular structure, which can be the same as, included in, or different than theauricular structure 22 to which themold material 30 is applied. For instance, as illustrated inFIG. 3C , thefirst splint 82 can include asplint body 84 that defines a first anatomical-facingsurface 85 and asecond surface 89 that is opposite thefirst surface 85. For instance, thefirst surface 85 can define first and second opposed terminal ends 85 a and 85 b, and thesecond surface 89 can extend from the firstterminal end 85 a to the secondterminal end 85 b. Thesecond surface 89 can be convex and curved along its extension between the firstterminal end 85 a and the secondterminal end 85 b, for instance from the firstterminal end 85 a to the secondterminal end 85 b. Thus, thesecond surface 89 can have a curvature that is greater than the curvature of the first surface 85 (which can have a curvature of zero). Thesplint body 84 can further define opposed end surfaces 86 a and 86 b, respectively, that each can extend between the first andsecond surfaces - The
splint 82 can define agap 88 that extends at least into thesplint body 84. For instance, thegap 88 can extend from thefirst end surface 86 a to thesecond end surface 86 b, and can further extend into thefirst surface 85 along a direction toward thesecond surface 89, and can terminate in thesplint body 84 without extending through to thesecond surface 89, or can alter. Thus, thefirst surface 85 can define afirst region 85 c and asecond region 85 d, such that thegap 88 is disposed between the first andsecond regions gap 88 can be sized to receive an auricular structure. For instance, thegap 88 can be sized to receive thehelical rim 32 or auricular lobe such that thefirst region 85 c of thefirst surface 85 is configured to face or abut the auricle, for instance at theantihelix 36. Thus, thefirst region 85 c can be substantially planar, curved, or undulating so as to define a desired anatomical geometry of theantihelix 36. Further, thegap 88 can be sized and shaped so as to define desired anatomical geometry of thehelical rim 32. In this regard, it should be appreciated that thehelical rim 32 can define a second auricular structure to which the at least oneauxiliary support structure 70 is configured to be attached. It should be appreciated that theauricular support system 20 can include a plurality of thesplints 82, having different sizes and shapes so as to correspond to the helical rims of different infants. For instance, thegaps 88 can be of different sizes and curvatures, and depths, different distances between the end surfaces 86 a and 86 b, and different geometries of thefirst region 85 c of thefirst surface 85. - Thus, when at least one or both of the
helical rim 32 and theantihelix 36 has an anatomical abnormality, thesplint 82 having an appropriate size can receive thehelical rim 32 and abut or face theantihelix 36, thereby causing thehelical rim 32 generally conform to the size and shape of thegap 88, and further causing the antihelix to generally conform to the surface geometry of thefirst region 85 c, for instance if thefirst region 85 c abuts theantihelix 36. Thus, thesplint 82 can further maintain thehelical rim 32 at a desired spatial relationship with respect to the antihelix. Further, thesplint 82 can be disposed relative to thedermal surface 26 at a desired spacing so as to correct the anatomical spacing between thehelical rim 32 and thedermal surface 26. In this regard, thesplint 82 can be referred to as a retractor, as thesplint 82 can maintain thehelical rim 32 in a retracted state, thereby decreasing the distance between thehelical rim 32 and thedermal surface 26. The introduction of themold material 30 to theauricular structure 22, thesplint 82, and thedermal surface 26 including the at least onesubstrate 27, and subsequent curing of themold material 30 about theauricular structure 22, thesplint 82, and thedermal surface 26 including the at least onesubstrate 27, can thus retain one or both of thehelical rim 32 and theantihelix 36 in an anatomically corrected position. When themold material 30 is removed from theauricular structure 22 and thedermal surface 26, the attachment of themold material 30 to thesplint 82 can cause themold material 30 to remove the splint from the auricle. Themold material 30 can be removed from thedermal surface 26 by removing the respective at least onesubstrate 27 from thedermal surface 26. Alternatively, themold material 30 can be removed from the respective at least onesubstrate 27 while the at least onesubstrate 27 is attached to the dermal surface. Themold material 30 can alternatively be removed from thesplint 82, and thesplint 82 can then be removed from thehelical rim 32. While thegap 88 has been described as sized to receive thehelical rim 32, it should be appreciated that thegap 88 can alternatively receive thelobule 46, so as to correct for a lobular defect as desired. - Referring now to
FIGS. 3A and 3D , thesecond splint 87 can be constructed as described above with respect to thefirst splint 82, with the exception that thesplint body 84 can be sized and shaped differently than thesplint body 84 of thefirst splint 82. For instance, at least one or more up to all of the first andsecond surfaces first region 85 c of thefirst surface 85, of thesecond splint 87 can be sized and shaped differently than those of thefirst splint 82. Furthermore, thegap 88 of thesecond splint 87 can be sized and shaped differently than thegap 88 of thefirst splint 82. In accordance with the illustrated embodiment, thegap 88 of thesecond splint 87 can be sized to receive thehelical rim 32 at the cranial end of the auricle, and thefirst region 85 c of the first surface of thesecond splint 87 can be configured to face or abut one or both of thetriangular fossa 34 and the helical crux 35 (seeFIG. 1A ). - The attachment of the
mold material 30 to theauricular structure 22, thesecond splint 87, and thedermal surface 26 can thus retain one or more up to all of thehelical rim 32, thetriangular fossa 34, or thehelical crux 35 in an anatomically corrected position. When themold material 30 is removed from theauricular structure 22 and thedermal surface 26, the attachment of themold material 30 to thesplint 87 can cause themold material 30 to remove thesplint 87 from the auricle. Alternatively, themold material 30 can be removed from thesplint 87, and thesplint 87 can then be removed from thehelical rim 32. While thegap 88 of thesecond splint 87 has been described as sized to receive thehelical rim 32, it should be appreciated that thegap 88 can alternatively receive thelobule 46, so as to correct for a lobular defect as desired. - Any of the
splints 80, for instance thesecond splint 87 as illustrated inFIG. 3E , can include one or more sections of the at least onesubstrate 27 that is attached to an outer surface of thesplint 87. For instance, as described above, thesplint 87 can include thefirst region 85 c that is configured to face or abut one or both of thetriangular fossa 34 or thehelical crux 35, Thesecond region 85 d is positioned such that when thesplint 80 is mounted onto theauricle 24 so that thehelical rim 32 is received in thegap 88, thesecond region 85 d can face thedermal surface 26, and thus thesubstrate 28. - Accordingly, at least one or more portions of the at least one
substrate 27 can be attached to the outer surface of thesecond region 85 d. In particular, the adhesive 58, and thus thefirst end 56 a, can be attached to thesecond region 85 d, such that thesecond end 56 b, and thus thefingers 62, face thesubstrate 28. Thefingers 62 of thesubstrate 28 that is attached to thedermal surface 26 can define one of hooks and loops, and thefingers 62 of the at least onesubstrate 27 that is attached to thesplint 80 can define the other of hooks and loops. Accordingly, thefingers 62 of the at least onesubstrate 27 that is attached to thesplint 80, and in particular to thesecond region 85 d, can attach to thesubstrate 28 that is attached to thedermal surface 26. Thus, thesecond region 85 d can define a thickness sufficient such that a desired spacing is maintained between the auricle 24 and thedermal surface 26 when the at least onesubstrate 27 of thesecond region 85 d is attached to thesubstrate 28. - Further, when the
splint 80 is mounted onto theauricle 24 so that thehelical rim 32 is received in thegap 88, thesecond end surface 86 b can face thesecond substrate 31. Accordingly, at least one or more portions of the at least onesubstrate 27 can be attached to thesecond end surface 86 b. In particular, the adhesive 58, and thus thefirst end 56 a, can be attached to thesecond end surface 86 b, such that thesecond end 56 b, and thus thefingers 62, face thesecond substrate 31. Thefingers 62 of thesecond substrate 31 that is attached to thedermal surface 26 can define one of hooks and loops, and thefingers 62 of the at least onesubstrate 27 that is attached to thesplint 80 can define the other of hooks and loops. Accordingly, thefingers 62 of the at least onesubstrate 27 that is attached to thesplint 80, and in particular to thesecond end surface 86 b, can attach to thesecond substrate 31 that is attached to thedermal surface 26. Thus, thesplint 80 can define a length from thefirst end surface 86 a to thesecond end surface 86 b that is sufficient such that a desired spacing is maintained between the auricle 24 and thedermal surface 26 when the at least onesubstrate 27 of thesecond end surface 86 b is attached to thesecond substrate 31. While the at least onesubstrate 27 that is attached to thesecond end surface 86 b can be attached to thesecond substrate 31 as described above, it should be appreciated that the at least onesubstrate 27 that is attached to thesecond end surface 86 b can alternatively be attached to asecond region 33 b of the at least onesubstrate 56 illustrated inFIG. 4A and described in more detail below. - It should be appreciated that the
auricular support system 20 can include a plurality of splints, including a plurality thefirst splints 82, a plurality of thesecond splints 87, and a plurality of any suitable alternatively constructed splint that is configured to attach to an auricular structure so as to correct an auricular deformity in the auricular structure to which it is attached. - Referring now to
FIGS. 4A-4C , it should be appreciated that one or more up to all of thesubstrates 27 can be constructed in accordance with any suitable alternative embodiment. The one or more of thesubstrates 27, alone or in combination, can substantially surround a portion up to substantially all of theauricle 24. For instance, the at least onesubstrate 27 can include a single substrate that substantially surrounds thehelical rim 32 as illustrated inFIG. 4B . Alternatively, as illustrated inFIGS. 1A and 3A , the at least onesubstrate 27 can include a plurality of substrates that in combination substantially surround at least a portion up to all of thehelical rim 32. - As illustrated in
FIGS. 4A-4C , thesubstrate body 56 can define afirst region 33 a and asecond region 33 b that can be substantially coplanar with thefirst region 33 a as illustrated inFIGS. 2B-C . Alternatively, thesecond region 33 b can be orientated angularly offset, such as substantially perpendicular, with respect to thefirst region 33 a. Thus, thefirst region 33 a can be configured to attach to thedermal surface 26, such that thesecond region 33 b, including the first andsecond surfaces second region 33 b, extends out from thedermal surface 26 at a non-zero angle with respect to thedermal surface 26. For instance, thesecond region 33 b, including the first andsecond surfaces second region 33 b, can extend substantially perpendicular with respect to thedermal surface 26. Thefirst end 56 a, such as thefirst surface 60 a, of thefirst region 33 a can thus carry the adhesive 58. For instance, thefirst end 56 a, such as thefirst surface 60 a, of thesecond region 33 b can be devoid of exposed adhesive 58. In accordance with one embodiment, thefirst end 56 a, such as thefirst surface 60 a, of thesecond region 33 b can be devoid of the adhesive 58. In accordance with another embodiment, thefirst end 56 a, such as thefirst surface 60 a, of thesecond region 33 b can carry the adhesive 58 that is covered by a backing, such that the adhesive 58 is not exposed. In this regard, it should be appreciated that thefirst end 56 a, such as thefirst surface 60 a, of thefirst region 33 a can carry the adhesive 58 that is covered by a backing that is removable so as to expose the adhesive 58. In the embodiments illustrated inFIGS. 2B-C , thefirst end 56 a, such as thefirst surface 60 a, of the first andsecond regions - In the embodiments illustrated in
FIGS. 2B-C and 4A-C, the at least onevoid 59 such as a plurality of voids that are configured to receive themold material 30 can be defined by thesecond end 56 b of thesecond region 33 b alone or in combination with thefirst region 33 a. Thus, thesecond region 33 b, alone or in combination with the first region, can define the matrix that defines the plurality ofvoids 59. It should be appreciated that thefirst end 56 a of thesecond region 33 b alone or in combination with thefirst region 33 a can define thefirst surface 60 a and the opposedsecond surface 60 b that is spaced from the first surface along 60 a along the transverse direction T. Thefirst surface 60 a of one or both of the first orsecond regions second region 33 b, alone or in addition to thefirst region 33 a, can include thefingers 62 that project from thesecond surface 60 b in the manner described above. Thus, thesubstrate body 56, for instance at thesecond end 56 b of thesecond region 33 b, alone or in combination with thefirst region 33 a, can define a matrix offingers 62 that project out from thesecond surface 60 b so as to define thevoids 59. Accordingly, during operation, when themold material 30 is received in thevoids 59, such that thefingers 62 are embedded in themold material 30, themold material 30 can cure so as to attach the mold material to thesecond region 33 b alone or in combination with the first region 30 a in the manner described above. It should be appreciated that thesecond substrate 31, along with any additional substrates of theauricular support system 20, can include the first andsecond regions - Referring to
FIG. 4D , it should be appreciated that the first andsecond substrates auricular support system 20 can be constructed in accordance with any suitable alternative embodiment so as to be attachable to thedermal surface 26 and define at least onevoid 59 such as a plurality ofvoids 59 that are suitable to receive themold material 30, such that themold material 30 is attached to the substrate when themold material 30 is cured. For instance, in accordance with one embodiment, the body of the at least onesubstrate 27 can define a sponge matrix that defines thevoids 59. Thevoids 59 can be elongate along a direction that includes the transverse direction T substantially alone or in combination with a direction that is perpendicular to the transverse direction, such that the voids that the voids can be disposed between thefirst end 56 a and a portion of thesecond end 56 b, which can be defined by the sponge matrix, along the transverse direction T. Thefirst end 56 a can be coated with or otherwise include the adhesive 58 that is configured to attach to thedermal surface 26 in the manner described above. - It should be appreciated that a kit can be provided that can include at least one or more, such as a plurality, of at least one or more up to all of the
mold material 30, the at least onesubstrate 27, and the at least oneauxiliary support structure 70. At least one of the at least onesubstrate 27 of the kit can be constructed having a different size and shape with respect to another one of the at least onesubstrate 27 of the kit in the manner described above. Further, at least one of theauxiliary support structure 70 can be constructed having a different size and shape with respect to another one of thesupport structure 70 of the kit in the manner described above. - A method for improving an auricular deformity can thus include the steps of attaching at least a portion of a first end of a substrate to a dermal surface, the substrate including a second end that defines at least one void, applying a mold material to both an articular structure and at least a portion of the substrate such that at least a portion of the mold material is embedded in the void, and after the applying step, allowing the mold material to cure so as to support the auricular structure relative to the substrate. The attaching can further include the step of attaching at least a portion of a first surface of the first end of the substrate to the dermal surface. The applying step can further include the step of applying the mold material to at least one finger of the substrate that extends from out a second surface of the first end that is opposite the first surface, so as to embed the at least one finger in the mold material. The substrate can include a plurality of fingers that project from the second surface, and the applying step can further include the step of embedding the plurality of fingers in the mold material. The attaching step can further include the step of attaching the first surface of a first region of the substrate to the dermal surface, such that a second region of the substrate projects out from the dermal surface at a non-zero angle with respect to the first region. The attaching step can further include the step of orienting the second region substantially perpendicular to the first region. The plurality of fingers can extend out from the second surface at the first region, and the applying step can further include coating at least a portion of the second surface with the mold material at the first region so as to embed the plurality of fingers in the mold material. The plurality of fingers can further project out from the second surface at the second region, and the applying step can further include coating at least a portion of the second surface with the mold material at the second region so as to embed the plurality of fingers in the mold material.
- The auricular structure can be a first auricular structure, and the method can further include the step of attaching at least one auxiliary support structure to a second auricular structure. The applying step can further include the step of applying the mold material to the auxiliary support structure so as to support the at least one auxiliary support structure relative to the substrate. The at least one auxiliary structure comprises a splint including a splint body that defines a gap, and the method further comprises the step of receiving the second auricular structure in the gap. The splint can be a helical rim retractor and the second auricular structure includes a helical rim, and the receiving step can include the step of receiving a helical rim in the gap. The at least one auxiliary support structure can include a conchal cavity former, the second auricular structure can include a conchal cavity, and the method can further include the step of inserting the conchal cavity former into a conchal cavity.
- Although the invention and its advantages have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments described herein. Furthermore, it should be appreciated that apparatus and methods described in connection with one embodiment can be equally applicable to all other embodiments unless otherwise indicated. One of ordinary skill in the art will readily appreciate from the present disclosure that apparatus and methods presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Thus, it will be appreciated by those skilled in the art that various modifications and alterations of the invention can be made without departing from the broad scope of the appended claims. Some of these have been discussed above and others will be apparent to those skilled in the art.
Claims (11)
1. A method for improving an auricular deformity, the method comprising the steps of:
attaching at least a portion of a first end of a substrate to a dermal surface, the substrate including a second end that defines at least one void;
applying a mold material to both an articular structure and at least a portion of the substrate such that at least a portion of the mold material is embedded in the void; and
after the applying step, allowing the mold material to cure so as to support the auricular structure relative to the substrate.
2. The method as recited in claim 1 , wherein the attaching step further comprises attaching at least a portion of a first surface of the first end of the substrate to the dermal surface, and the applying step further comprises applying the mold material to at least one finger of the substrate that extends from out a second surface of the first end that is opposite the first surface, so as to embed the at least one finger in the mold material.
3. The method as recited in claim 2 , wherein the substrate comprises a plurality of fingers that project from the second surface, and the applying step further comprises embedding the plurality of fingers in the mold material.
4. The method as recited in claim 1 , wherein the attaching step further comprises attaching the first surface of a first region of the substrate to the dermal surface, such that a second region of the substrate projects out from the dermal surface at a non-zero angle with respect to the first region.
5. The method as recited in claim 4 , wherein the attaching step further comprises orienting the second region substantially perpendicular to the first region.
6. The method as recited in claim 4 , wherein the plurality of fingers extend out from the second surface at the first region, and the applying step further comprises coating at least a portion of the second surface with the mold material at the first region so as to embed the plurality of fingers in the mold material.
7. The method as recited in claim 4 , wherein the plurality of fingers further project out from the second surface at the second region, and the applying step further comprises coating at least a portion of the second surface with the mold material at the second region so as to embed the plurality of fingers in the mold material.
8. The method as recited in claim 1 , wherein the auricular structure is a first auricular structure, the method further comprising the step of attaching at least one auxiliary support structure to a second auricular structure, and the applying step further comprises applying the mold material to the auxiliary support structure so as to support the at least one auxiliary support structure relative to the substrate.
9. The method as recited in claim 8 , wherein the at least one auxiliary structure comprises a splint including a splint body that defines a gap, and the method further comprises the step of receiving the second auricular structure in the gap.
10. The method as recited in claim 9 , wherein the splint is a helical rim retractor and the second auricular structure includes a helical rim, and the receiving step further comprises receiving a helical rim in the gap.
11. The method as recited in claim 8 , wherein the at least one auxiliary support structure comprises a conchal cavity former and the second auricular structure includes a conchal cavity, and the method further comprises the step of inserting the conchal cavity former into a conchal cavity.
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SE533602C2 (en) | 2009-03-16 | 2010-11-02 | Ola Oequist | Device for making an impression of an ear |
US9732321B2 (en) | 2010-02-16 | 2017-08-15 | The General Hospital Corporation | Engineered craniofacial constructs with composite scaffold |
US20120017359A1 (en) | 2010-07-26 | 2012-01-26 | Marcia Helena Parris | Ear Protector |
US20130068238A1 (en) * | 2010-07-26 | 2013-03-21 | Marcia Helena Parris | Ear Protector and Ear Protector Wrap |
US9591879B2 (en) * | 2010-11-24 | 2017-03-14 | Kenneth J. Michlitsch | Methods and apparatus for ear protection |
CN202478412U (en) | 2011-11-28 | 2012-10-10 | 孙吉 | Customized ear mold health care acupoint plaster |
-
2014
- 2014-01-02 JP JP2015551758A patent/JP6434421B2/en active Active
- 2014-01-02 US US14/758,877 patent/US11185446B2/en active Active
- 2014-01-02 WO PCT/US2014/010102 patent/WO2014107532A1/en active Application Filing
- 2014-01-02 AU AU2014204042A patent/AU2014204042B2/en active Active
- 2014-01-02 EP EP14735382.5A patent/EP2941224B1/en not_active Revoked
- 2014-01-02 ES ES14735382.5T patent/ES2669618T3/en active Active
- 2014-01-02 CA CA2896954A patent/CA2896954C/en active Active
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WO2014107532A1 (en) | 2014-07-10 |
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AU2014204042A1 (en) | 2015-07-30 |
NO3024466T3 (en) | 2018-09-01 |
EP2941224A4 (en) | 2016-08-17 |
AU2014204042B2 (en) | 2017-12-21 |
ES2669618T3 (en) | 2018-05-28 |
CA2896954A1 (en) | 2014-07-10 |
JP2016501702A (en) | 2016-01-21 |
EP2941224B1 (en) | 2018-02-28 |
TR201806835T4 (en) | 2018-06-21 |
EP2941224A1 (en) | 2015-11-11 |
US20150335491A1 (en) | 2015-11-26 |
JP6434421B2 (en) | 2018-12-05 |
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