US20150005806A1 - Rhinoplasty appliance and method of forming the same - Google Patents
Rhinoplasty appliance and method of forming the same Download PDFInfo
- Publication number
- US20150005806A1 US20150005806A1 US14/317,840 US201414317840A US2015005806A1 US 20150005806 A1 US20150005806 A1 US 20150005806A1 US 201414317840 A US201414317840 A US 201414317840A US 2015005806 A1 US2015005806 A1 US 2015005806A1
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- United States
- Prior art keywords
- rhinoplasty
- appliance
- patient
- nostril
- appliance according
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- Abandoned
Links
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- 238000000034 method Methods 0.000 title claims description 13
- 238000003780 insertion Methods 0.000 claims abstract description 34
- 230000037431 insertion Effects 0.000 claims abstract description 34
- 238000001356 surgical procedure Methods 0.000 claims abstract description 13
- 241000083547 Columella Species 0.000 claims abstract description 8
- 239000000203 mixture Substances 0.000 claims description 16
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- 229920005989 resin Polymers 0.000 claims description 13
- 230000000717 retained effect Effects 0.000 claims description 7
- 125000006850 spacer group Chemical group 0.000 claims description 7
- 239000003814 drug Substances 0.000 claims description 6
- 229910001220 stainless steel Inorganic materials 0.000 claims description 6
- 239000000853 adhesive Substances 0.000 claims description 5
- 230000001070 adhesive effect Effects 0.000 claims description 5
- 239000010935 stainless steel Substances 0.000 claims description 5
- 229940124597 therapeutic agent Drugs 0.000 claims description 5
- 239000012815 thermoplastic material Substances 0.000 claims description 5
- 239000004925 Acrylic resin Substances 0.000 claims description 4
- 229920000178 Acrylic resin Polymers 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 210000003928 nasal cavity Anatomy 0.000 claims description 3
- 239000012858 resilient material Substances 0.000 claims description 2
- 229920001169 thermoplastic Polymers 0.000 claims description 2
- 239000004416 thermosoftening plastic Substances 0.000 claims description 2
- 230000008878 coupling Effects 0.000 claims 1
- 238000010168 coupling process Methods 0.000 claims 1
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- 230000014759 maintenance of location Effects 0.000 abstract description 3
- 210000003484 anatomy Anatomy 0.000 abstract description 2
- 239000000463 material Substances 0.000 description 3
- 206010009269 Cleft palate Diseases 0.000 description 2
- 208000031481 Pathologic Constriction Diseases 0.000 description 2
- 206010009259 cleft lip Diseases 0.000 description 2
- 230000035876 healing Effects 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
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- 230000036262 stenosis Effects 0.000 description 2
- 208000037804 stenosis Diseases 0.000 description 2
- 208000004468 Craniofacial Abnormalities Diseases 0.000 description 1
- 208000035752 Live birth Diseases 0.000 description 1
- 241000124008 Mammalia Species 0.000 description 1
- 206010062575 Muscle contracture Diseases 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
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Images
Classifications
-
- 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
- A61F5/08—Devices for correcting deformities of the nose ; Devices for enlarging the nostril, e.g. for breathing improvement
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
- B29C39/02—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles
- B29C39/10—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor for making articles of definite length, i.e. discrete articles incorporating preformed parts or layers, e.g. casting around inserts or for coating articles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2033/00—Use of polymers of unsaturated acids or derivatives thereof as moulding material
- B29K2033/04—Polymers of esters
- B29K2033/08—Polymers of acrylic acid esters, e.g. PMA, i.e. polymethylacrylate
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2305/00—Use of metals, their alloys or their compounds, as reinforcement
- B29K2305/08—Transition metals
- B29K2305/12—Iron
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
Definitions
- Cleft palate is one of the most common craniofacial disorders, with a prevalence of 1/700 live births.
- Craniofacial problems are not only of skeletal nature, but may also involve musculature and soft tissue.
- round tubes were used following surgery to resist nasal stenosis.
- round tubes have proven unsuitable aesthetically because they promote healing of the nostril with a round shape, which is unappealing since the normal nostril shape is not truly round.
- soft silicone rubber stents, tubes or scaffolds have been specifically made for the human nostril shape. These stents tend to easily fall out or be extruded in use, particularly in children. They may be retained in proper placement with transseptal sutures, but sutures may be uncomfortable or may have complications. Even with the use of suture retention, these stents typically are not retained in place in children for longer than a few weeks. Additionally, cases have been reported where the transseptal sutures have cut through the columella.
- a rhinoplasty appliance for use after surgery that protects the columella and nasal nostrils while improving and maintaining the desired shape and form of the nasal nostril. It is also desirable to provide such a rhinoplasty appliance that is more comfortable, easy to make, and not easily extruded when in use.
- the subject invention provides a rhinoplasty appliance that is custom-molded to a patient's nasal nostrils to maintain the corrected contour of the nostrils after rhinoplastic surgery.
- the subject invention further provides methods of using the rhinoplasty appliance.
- the rhinoplasty appliance is, advantageously, easy and inexpensive to manufacture from readily available materials, such as metals and thermoplastic materials.
- a rhinoplasty appliance which may be removably inserted within the nostrils of a patient may have a first and second nostril insertion portions, a connecting structure, and a first and second flange.
- the nostril insertion portions may each have a passage and an aperture to permit flow of air and drainage.
- the connecting structure may couple the first and second nostril insertion portions to each other.
- the first flange may be affixed to the first nostril insertion portion, and the second flange may be affixed to the second nostril insertion portion.
- the first and second flanges may each have a fastener.
- the first and second nostril insertion portions and the connecting structure may be integrally molded of a thermoplastic material.
- the first and second nostril insertion portions and the connecting structure may be customized to fit the patient's nostrils.
- the connecting structure may also have a support wire, which may be stainless steel.
- the first and second flanges may be made of resilient material, which may also be stainless steel.
- the fastener may be, for example, a loop, a hook, or at least one adhesive.
- the rhinoplasty appliance may also have a therapeutic agent.
- the apertures of the first and second nostril insertion portions may have an elliptical shape. At least one cannula may be inserted through an aperture and extend into a passage.
- a rhinoplasty appliance may be formed by making an impression of the nasal cavity of a patient; forming a mold from the impression, including a first and second nasal nostrils and a columella; placing a liquid resin mix within the first and second nasal nostrils and around the columella of the mold; inserting a support wire, a first and second flanges, and a first and second aperture spacers into the resin mix before the mix sets; and after the mix sets, removing the first and second aperture spacers.
- the resin mix may be a thermoplastic acrylic resin.
- a rhinoplasty appliance may be provided to a patient, a first and second nostril insertion portions may be inserted into the patient's nostrils; the first and second wire flanges may be retained in position on the patient's face; and the rhinoplasty appliance may be worn to maintain at least one nostril structure.
- the patient may be a human baby, infant, child, adolescent, or adult.
- the rhinoplasty appliance may be worn continuously for about two to three months following corrective surgery. After wearing the rhinoplasty appliance continuously for about two to three months, the rhinoplasty appliance may be worn at night for about four to six months.
- the first and second flanges may be retained on the patient's face using elastic bands or adhesive.
- FIG. 1 shows a top perspective view of an embodiment of the subject invention.
- FIG. 2 shows a front view of a portion of the face of a typical patient with the embodiment of FIG. 1 inserted and retained in place in the patient's nostrils.
- FIG. 3 shows a mold from a patient's nose.
- FIG. 4 shows the manner of pouring the resin mix from which the embodiment of FIG. 1 is formed.
- FIG. 5 shows an exploded perspective view of the mold of FIG. 4 .
- FIG. 6 shows an exploded view of the embodiment of FIG. 1 once set and removed from the mold of FIG. 5 .
- patient refers to a mammal, preferably a human, to which the present invention is applied.
- Those that can benefit from the disclosed rhinoplasty appliance include, but are not limited to, neonates, infants, children, adolescents and adults.
- references to “first”, “second”, and the like are intended to identify a particular feature of which there are at least two. However, these references are not intended to confer any order in time, structural orientation, or sidedness (e.g., left or right) with respect to a particular feature.
- the invention comprises a rhinoplasty appliance shown generally at 10 .
- a rhinoplasty appliance 10 comprises a first and second nostril insertion portions 15 a, 15 b and a connecting structure 20 , all of which are preferably integrally molded from an elastomeric and/or thermoplastic material (e.g., silicone, rubber, plastic).
- the thermoplastic material is an acrylic resin.
- the acrylic resin is derived from an orthodontic resin powder and liquid as more fully described later herein.
- the first and second insertion portions 15 a, 15 b are generally identical in shape and size and each include a passage and an aperture 25 a, 25 b to ensure air flow and drainage when in use.
- the first and second insertion portions 15 a, 15 b are custom formed to fit within the nostrils of the patient and conform to the internal shape thereof In certain embodiments, the first and second insertion portions are roughly between about 1 to 25 mm in length, more preferably about 3 to 15 mm in length; and roughly between about 1 to 15 mm in diameter, more preferably about 3 to 7 mm in diameter.
- the size and shape of the first and second insertion portions are customized to the patient and the lengths and diameters of the insertion portions will vary.
- the connecting structure 20 comprises a support wire 30 .
- the first and second insertion portions 15 a, 15 b each comprise wire flanges 35 a, 35 b.
- the support wire 30 and the wire flanges 35 a, 35 b may be made of resilient, semi-rigid or rigid material (e.g., metal).
- the support wire 30 and the wire flanges 35 a, 35 b can be made of stainless steel.
- the diameter of the stainless steel wire is about 0.5mm to about 1.5 mm, more preferably approximately 0.9 mm.
- the support wire 30 is formed with a series of bends 40 in order to anchor the same firmly within the connecting structure 20 while it sets.
- the wire flanges 35 a, 35 b are formed with bends 45 at the proximal ends to anchor the same within the insertion portions 15 a, 15 b .
- the distal ends of the wire flanges 35 a, 35 b terminate in a small loop or hook 50 to assist in securing the appliance 10 to the patient and to avoid a sharp end which could cut or damage the patient or surgeon.
- the first and second insertion portions 15 a, 15 b are formed to fit within the nostrils of the patient.
- adhesives are placed at the distal ends of the wire flanges 35 a, 35 b to secure the appliance 10 to the patient's face and prevent withdrawal or expulsion of the insertion portions 15 a, 15 b from the patient's nostrils.
- one or more elastic bands are placed in the loops 50 to assist securing the appliance 10 to the patient's face.
- a single elastic band may be used to connect the distal ends of the wire flanges 35 a, 35 b to secure the appliance to the patient's head.
- the lengths of the wire flanges will vary to ensure proper fixation to the patient's face
- the rhinoplasty appliance can further comprise a therapeutic agent.
- Therapeutic agents may be incorporated in the appliance or may be provided on the surface of the appliance. Examples of therapeutic agents include, but are not limited to, antibiotics and other medications.
- a neonatal rhinoplasty appliance may have a length of approximately 8-10 mm, a height of approximately 5-7mm, and a width of approximately 4-5 mm.
- a pediatric rhinoplasty appliance may have a length of approximately 10-12 mm, a height of approximately 8-10 mm, and a width of approximately 6 mm.
- an adolescent rhinoplasty appliance may have a length of approximately 10-15 mm, a height of approximately 11-13 mm, and a width of approximately 7 mm. All of the dimensions of each specific example may be adjusted by a millimeter or more to better fit the patient's anatomy.
- the rhinoplasty appliance described above is of primary importance in restoring the nostril size and shape, especially for patients with cleft lip or crania-facial anomalies.
- conventional nasal stents the same are used for no more than one week post surgery and in many cases, the nasal tissue may collapse and will not permit optimal aesthetic results.
- the rhinoplasty appliance may also be used with patients requiring a nasal cannula, such as a medical tube providing oxygen.
- the appliance may be used to protect the columnella during insertion of a cannula through an aperture and extending into a passage.
- an impression of the patient's nose is taken using any orthodontic or similar mold casting material, see FIG. 3 .
- the resulting mold 100 serves as a reservoir into which a mixture of orthodontic resin powder and liquid 105 may be poured as shown in FIG. 4 .
- the mold provides an impression of the patient's nostrils and columella to which the resin mixture is applied.
- a support wire 30 , wire flanges 35 a, 35 b and aperture spacers 60 are inserted in the mold, see FIG. 5 .
- Aperture spacers 60 are employed to ensure a passage and opening are formed in the nostril insertion portions 15 a, 15 b to permit flow of air and drainage.
- the subject rhinoplasty appliance is provided.
- the nostril insertion portions are inserted into a patient's nostrils and the wire flanges are affixed to the patient's face following corrective surgery.
- the rhinoplasty appliance is used 24 hours a day.
- the rhinoplasty appliance is used 24 hours a day for about two to three months.
- intermittent visits can be conducted with a clinician for any revisions or adjustments to the rhinoplasty appliance.
- the rhinoplasty appliance is worn only at night.
- the rhinoplasty appliance is worn at night for about four to six months. Because recurrence of nostril stenosis and other nostril shape abnormalities may occur, overcorrection is recommended.
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- Health & Medical Sciences (AREA)
- Otolaryngology (AREA)
- Pulmonology (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
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Abstract
A rhinoplasty appliance is provided that may be custom-molded to a patient's nasal anatomy, including the nostrils, to maintain the corrected contour of the nostrils after rhinoplastic surgery. The rhinoplasty appliance may include a support wire; a first and second wire flanges; a first and second nostril insertion portions, each having a passage and an aperture to permit flow of air and drainage; a connecting structure to maintain the position of the nostril insertion portions in relation to each other, and to provide support and protection for the columella. The first and second wire flange may help to secure the rhinoplasty appliance in position on the patient's face, and improve retention of the first and second nostril insertion portions in the patient's nostrils. The support wire may be provided as added support for the connecting structure.
Description
- This application claims the benefit of U.S. provisional application Ser. No. 61/841,504, filed Jul. 1, 2013, which is incorporated herein by reference in its entirety.
- Cleft palate is one of the most common craniofacial disorders, with a prevalence of 1/700 live births. Craniofacial problems are not only of skeletal nature, but may also involve musculature and soft tissue.
- Clinicians, particularly plastic surgeons, face difficulties in maintaining the corrected shape and size of the human nostril following surgery in patients with cleft lip and/or palate, cranio-facial abnormalities and the like. For example, the forces of scar contracture may lead to stenotic nostrils. In many such cases, after surgery, a nasal stent of a fixed size dependent on the patient's specific measurements and nostril configuration may be inserted and retained in the nasal cavity.
- Previously, round tubes were used following surgery to resist nasal stenosis. However, such round tubes have proven unsuitable aesthetically because they promote healing of the nostril with a round shape, which is unappealing since the normal nostril shape is not truly round.
- To address this problem, soft silicone rubber stents, tubes or scaffolds have been specifically made for the human nostril shape. These stents tend to easily fall out or be extruded in use, particularly in children. They may be retained in proper placement with transseptal sutures, but sutures may be uncomfortable or may have complications. Even with the use of suture retention, these stents typically are not retained in place in children for longer than a few weeks. Additionally, cases have been reported where the transseptal sutures have cut through the columella.
- Therefore, there is currently an unmet need for a rhinoplasty appliance for use after surgery that protects the columella and nasal nostrils while improving and maintaining the desired shape and form of the nasal nostril. It is also desirable to provide such a rhinoplasty appliance that is more comfortable, easy to make, and not easily extruded when in use.
- The subject invention provides a rhinoplasty appliance that is custom-molded to a patient's nasal nostrils to maintain the corrected contour of the nostrils after rhinoplastic surgery. The subject invention further provides methods of using the rhinoplasty appliance. The rhinoplasty appliance is, advantageously, easy and inexpensive to manufacture from readily available materials, such as metals and thermoplastic materials.
- In a specific embodiment, a rhinoplasty appliance which may be removably inserted within the nostrils of a patient may have a first and second nostril insertion portions, a connecting structure, and a first and second flange. The nostril insertion portions may each have a passage and an aperture to permit flow of air and drainage. The connecting structure may couple the first and second nostril insertion portions to each other. The first flange may be affixed to the first nostril insertion portion, and the second flange may be affixed to the second nostril insertion portion. The first and second flanges may each have a fastener.
- The first and second nostril insertion portions and the connecting structure may be integrally molded of a thermoplastic material. The first and second nostril insertion portions and the connecting structure may be customized to fit the patient's nostrils. The connecting structure may also have a support wire, which may be stainless steel. The first and second flanges may be made of resilient material, which may also be stainless steel. The fastener may be, for example, a loop, a hook, or at least one adhesive. The rhinoplasty appliance may also have a therapeutic agent. The apertures of the first and second nostril insertion portions may have an elliptical shape. At least one cannula may be inserted through an aperture and extend into a passage.
- The subject invention includes methods for maintaining the patency of nostril structure following corrective surgery. In one such method, a rhinoplasty appliance may be formed by making an impression of the nasal cavity of a patient; forming a mold from the impression, including a first and second nasal nostrils and a columella; placing a liquid resin mix within the first and second nasal nostrils and around the columella of the mold; inserting a support wire, a first and second flanges, and a first and second aperture spacers into the resin mix before the mix sets; and after the mix sets, removing the first and second aperture spacers. The resin mix may be a thermoplastic acrylic resin.
- In another method, a rhinoplasty appliance may be provided to a patient, a first and second nostril insertion portions may be inserted into the patient's nostrils; the first and second wire flanges may be retained in position on the patient's face; and the rhinoplasty appliance may be worn to maintain at least one nostril structure. The patient may be a human baby, infant, child, adolescent, or adult. The rhinoplasty appliance may be worn continuously for about two to three months following corrective surgery. After wearing the rhinoplasty appliance continuously for about two to three months, the rhinoplasty appliance may be worn at night for about four to six months. The first and second flanges may be retained on the patient's face using elastic bands or adhesive.
- In order that a more precise understanding of the above-recited invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof that are illustrated in the appended drawings. The drawings presented herein may not be drawn to scale and any reference or implication of dimensions in the drawings or the following description are specific to the embodiments disclosed. Any variations of these dimensions that will allow the subject invention to function for its intended purpose are within the scope of the subject invention. Thus, these drawings depict only specific embodiments of the invention and are not limiting in scope.
-
FIG. 1 shows a top perspective view of an embodiment of the subject invention. -
FIG. 2 shows a front view of a portion of the face of a typical patient with the embodiment ofFIG. 1 inserted and retained in place in the patient's nostrils. -
FIG. 3 shows a mold from a patient's nose. -
FIG. 4 shows the manner of pouring the resin mix from which the embodiment ofFIG. 1 is formed. -
FIG. 5 shows an exploded perspective view of the mold ofFIG. 4 . -
FIG. 6 shows an exploded view of the embodiment ofFIG. 1 once set and removed from the mold ofFIG. 5 . - The term “patient” as used herein, refers to a mammal, preferably a human, to which the present invention is applied. Those that can benefit from the disclosed rhinoplasty appliance include, but are not limited to, neonates, infants, children, adolescents and adults.
- References to “first”, “second”, and the like (e.g., first and second securing wire), as used herein, and unless otherwise specifically stated, are intended to identify a particular feature of which there are at least two. However, these references are not intended to confer any order in time, structural orientation, or sidedness (e.g., left or right) with respect to a particular feature.
- With reference to the drawings wherein like reference characters designate like or corresponding elements throughout the several views, it will be seen that the invention comprises a rhinoplasty appliance shown generally at 10.
- In the embodiment shown in
FIG. 1 , arhinoplasty appliance 10 comprises a first and secondnostril insertion portions structure 20, all of which are preferably integrally molded from an elastomeric and/or thermoplastic material (e.g., silicone, rubber, plastic). Preferably, the thermoplastic material is an acrylic resin. Even more preferably, the acrylic resin is derived from an orthodontic resin powder and liquid as more fully described later herein. - The first and
second insertion portions aperture second insertion portions - The connecting
structure 20 comprises asupport wire 30. The first andsecond insertion portions wire flanges support wire 30 and thewire flanges support wire 30 and thewire flanges - The
support wire 30 is formed with a series ofbends 40 in order to anchor the same firmly within the connectingstructure 20 while it sets. The wire flanges 35 a, 35 b are formed withbends 45 at the proximal ends to anchor the same within theinsertion portions wire flanges hook 50 to assist in securing theappliance 10 to the patient and to avoid a sharp end which could cut or damage the patient or surgeon. - As illustrated in
FIG. 2 , the first andsecond insertion portions wire flanges appliance 10 to the patient's face and prevent withdrawal or expulsion of theinsertion portions loops 50 to assist securing theappliance 10 to the patient's face. In a related embodiment, a single elastic band may be used to connect the distal ends of thewire flanges - The rhinoplasty appliance can further comprise a therapeutic agent. Therapeutic agents may be incorporated in the appliance or may be provided on the surface of the appliance. Examples of therapeutic agents include, but are not limited to, antibiotics and other medications.
- Proper fit and retention is very important since the rhinoplasty appliance may be worn for many months both at night and during the day. To enhance patient comfort and fit of the rhinoplasty appliance, several of the most likely sizes and dimensions may be made in advance, or the rhinoplasty appliance may be individually customized to each patient. Some examples may include providing rhinoplasty appliances having more than one range of sizes, which may roughly correspond to patients who may be characterized as neonatal, pediatric, or adolescent. In a first specific example, a neonatal rhinoplasty appliance may have a length of approximately 8-10 mm, a height of approximately 5-7mm, and a width of approximately 4-5 mm. In a second specific example, a pediatric rhinoplasty appliance may have a length of approximately 10-12 mm, a height of approximately 8-10 mm, and a width of approximately 6 mm. In a third specific example, an adolescent rhinoplasty appliance may have a length of approximately 10-15 mm, a height of approximately 11-13 mm, and a width of approximately 7 mm. All of the dimensions of each specific example may be adjusted by a millimeter or more to better fit the patient's anatomy.
- The rhinoplasty appliance described above is of primary importance in restoring the nostril size and shape, especially for patients with cleft lip or crania-facial anomalies. With conventional nasal stents, the same are used for no more than one week post surgery and in many cases, the nasal tissue may collapse and will not permit optimal aesthetic results.
- The rhinoplasty appliance may also be used with patients requiring a nasal cannula, such as a medical tube providing oxygen. The appliance may be used to protect the columnella during insertion of a cannula through an aperture and extending into a passage.
- In order to custom-form the rhinoplasty appliance, an impression of the patient's nose is taken using any orthodontic or similar mold casting material, see
FIG. 3 . The resultingmold 100 serves as a reservoir into which a mixture of orthodontic resin powder and liquid 105 may be poured as shown inFIG. 4 . Specifically, the mold provides an impression of the patient's nostrils and columella to which the resin mixture is applied. - Before the resin mix is poured into the mold or before the resin mix sets, a
support wire 30,wire flanges aperture spacers 60 are inserted in the mold, seeFIG. 5 .Aperture spacers 60 are employed to ensure a passage and opening are formed in thenostril insertion portions FIG. 6 and thespacers 60 may be removed. - To maintain the patency of nostril structure following surgery, the subject rhinoplasty appliance is provided. The nostril insertion portions are inserted into a patient's nostrils and the wire flanges are affixed to the patient's face following corrective surgery. During the first period of healing, the rhinoplasty appliance is used 24 hours a day. Preferably, the rhinoplasty appliance is used 24 hours a day for about two to three months. During this period, intermittent visits can be conducted with a clinician for any revisions or adjustments to the rhinoplasty appliance. Following this period, the rhinoplasty appliance is worn only at night. Preferably, the rhinoplasty appliance is worn at night for about four to six months. Because recurrence of nostril stenosis and other nostril shape abnormalities may occur, overcorrection is recommended.
- All patents, patent applications, provisional applications, and publications referred to or cited herein are incorporated by reference in their entirety, including all figures and tables, to the extent they are not inconsistent with the explicit teachings of this specification.
- It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application and the scope of the appended claims. In addition, any elements or limitations of any invention or embodiment thereof disclosed herein can be combined with any and/or all other elements or limitations (individually or in any combination) or any other invention or embodiment thereof disclosed herein, and all such combinations are contemplated with the scope of the invention without limitation thereto.
Claims (19)
1. A rhinoplasty appliance for removable insertion within the nostrils of a patient comprising:
a first and second nostril insertion portions, each having a passage and an aperture to permit flow of air and drainage;
a connecting structure coupling the first and second nostril insertion portions; and
a first flange affixed to the first nostril insertion portion, and a second flange affixed to the second nostril insertion portion;
wherein the first and second flanges each have a fastener.
2. The rhinoplasty appliance according to claim 1 , wherein the first and second nostril insertion portions and the connecting structure are integrally molded of a thermoplastic material.
3. The rhinoplasty appliance according to claim 1 , wherein the first and second nostril insertion portions and the connecting structure are customized to fit the patient's nostrils.
4. The rhinoplasty appliance according to claim 1 , wherein the connecting structure further comprises a support wire.
5. The rhinoplasty appliance according to claim 4 , wherein the support wire is stainless steel.
6. The rhinoplasty appliance according to claim 1 , wherein the first and second flanges are made of resilient material.
7. The rhinoplasty appliance according to claim 6 , wherein the first and second flanges are stainless steel.
8. The rhinoplasty appliance according to claim 1 , wherein the fastener is selected from the group consisting of: a loop, a hook, and one or more adhesives.
9. The rhinoplasty appliance according to claim 1 , further comprising a therapeutic agent.
10. The rhinoplasty appliance according to claim 1 , wherein the aperture of the first and second nostril insertion portions has an elliptical shape.
11. The rhinoplasty appliance according to claim 1 , further comprising at least one cannula inserted through an aperture and extending into a passage.
12. A method of forming a rhinoplasty appliance including the steps of:
(a) making an impression of the nasal cavity of a patient,
(b) forming a mold from said impression, which includes a first and second nasal nostrils and a columella,
(c) placing a liquid resin mix within the first and second nasal nostrils and around the columella of the mold,
(d) inserting a support wire, a first and second flanges, and a first and second aperture spacers into the resin mix before the mix sets, and
(e) after the mix sets, removing the first and second aperture spacers.
13. The method of claim 12 , wherein the resin mix is a thermoplastic acrylic resin.
14. A method of maintaining at least one nostril structure following corrective surgery, comprising:
(a) providing a rhinoplasty appliance according to claim 1 to a patient;
(b) inserting the first and second nostril insertion portions into the patient's nostrils;
(c) retaining the first and second wire flanges in position on the patient's face; and
(d) wearing the rhinoplasty appliance to maintain at least one nostril structure.
15. The method of claim 14 , wherein the patient is human and selected from the group consisting of: neonate, infant, child, adolescent, and adult.
16. The method of claim 14 , wherein the rhinoplasty appliance is worn continuously for about two to three months following corrective surgery.
17. The method of claim 16 , wherein following wearing the rhinoplasty appliance continuously for about two to three months, the rhinoplasty appliance is worn at night for about four to six months.
18. The method of claim 14 , wherein the first and second flanges are retained on the patient's face using elastic bands or adhesive.
19. The method of claim 13 , further comprising inserting at least one cannula through an aperture and into a passage.
Priority Applications (2)
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US14/317,840 US20150005806A1 (en) | 2013-07-01 | 2014-06-27 | Rhinoplasty appliance and method of forming the same |
US16/367,923 US11166835B2 (en) | 2013-07-01 | 2019-03-28 | Rhinoplasty appliance and method of forming the same |
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US201361841504P | 2013-07-01 | 2013-07-01 | |
US14/317,840 US20150005806A1 (en) | 2013-07-01 | 2014-06-27 | Rhinoplasty appliance and method of forming the same |
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US16/367,923 Continuation US11166835B2 (en) | 2013-07-01 | 2019-03-28 | Rhinoplasty appliance and method of forming the same |
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US20150005806A1 true US20150005806A1 (en) | 2015-01-01 |
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US16/367,923 Active 2035-07-02 US11166835B2 (en) | 2013-07-01 | 2019-03-28 | Rhinoplasty appliance and method of forming the same |
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US16/367,923 Active 2035-07-02 US11166835B2 (en) | 2013-07-01 | 2019-03-28 | Rhinoplasty appliance and method of forming the same |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107928854A (en) * | 2017-11-13 | 2018-04-20 | 深圳市福生医疗器械有限公司 | A kind of harelip nose pillar retention clip |
WO2022076795A1 (en) * | 2020-10-08 | 2022-04-14 | New York University | Nasal molding device |
US20230008837A1 (en) * | 2021-07-06 | 2023-01-12 | CMH Lahore Medical College & IOD | Nasal Impression Assembly and Method of Measuring/Imprinting the Nasal Impression |
USD991449S1 (en) * | 2019-01-16 | 2023-07-04 | Jon Garito | Rhinoplasty instrument |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2672138A (en) * | 1950-09-05 | 1954-03-16 | Carlock Marion Pomeroy | Device to promote nasal breathing and prevent snoring |
US20060085027A1 (en) * | 2001-05-22 | 2006-04-20 | Sanostec Corp. | Nasal congestion, obstruction relief, and drug delivery |
US20070107731A1 (en) * | 2005-11-15 | 2007-05-17 | Reed Glen B | Clip-in nostril expander |
US20090248058A1 (en) * | 2008-04-01 | 2009-10-01 | Robert Kotler | Device and Method for Maintaining Unobstructed Nasal Passageways after Nasal Surgery |
US20090277459A1 (en) * | 2008-05-09 | 2009-11-12 | Jordan Innovation Center For Engineers And Industrial Enterprises Royal Scientific Society | Nasal Device Useful for Prevention of Snoring and Sleeping Apnea |
US20140261459A1 (en) * | 2013-03-15 | 2014-09-18 | Fram Trak Industries | Antimicrobial nasal insert and method of manufacturing |
US9004071B2 (en) * | 2011-10-18 | 2015-04-14 | Ian Joseph Alexander | Nasal guide and method of use thereof |
Family Cites Families (32)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4221217A (en) * | 1978-05-01 | 1980-09-09 | Amezcua Saul O | Nasal device |
US5533506A (en) * | 1995-01-13 | 1996-07-09 | Medlife, Inc. | Nasal tube assembly |
US5775335A (en) * | 1997-05-29 | 1998-07-07 | Seal; Daniel J. | Apparatus to diminish or eliminate snoring |
US5895409A (en) * | 1997-09-16 | 1999-04-20 | Mehdizadeh; Hamid | Nasal dilator |
US6270512B1 (en) * | 1998-01-22 | 2001-08-07 | Jean V Rittmann | Internal nasal dilator |
US6004342A (en) * | 1998-03-26 | 1999-12-21 | Filis; Elias A. | Nasal insert device for improving breathing |
CA2252323A1 (en) * | 1998-11-03 | 2000-05-03 | Jung-Fu Chen | Stuff-in type nose plug with air filters |
US6561188B1 (en) * | 2000-08-21 | 2003-05-13 | Ellis Alan D | Nasal breathing apparatus and methods |
US6564800B1 (en) * | 2000-09-20 | 2003-05-20 | Juan Rodriguez Olivares | Nasal air passage device |
US7390331B2 (en) * | 2001-05-22 | 2008-06-24 | Sanostec Corp | Nasal inserts |
US20140246023A1 (en) * | 2006-02-28 | 2014-09-04 | Paz Maryanka | Nasal cavity dilator device |
ES2450925T3 (en) * | 2002-09-18 | 2014-03-25 | Asap Breathe Assist Pty Ltd | Dilator of the nasal cavity |
US20040147954A1 (en) * | 2003-01-14 | 2004-07-29 | Wood Charles E. | Internal nasal dilator |
US20040237967A1 (en) * | 2003-05-31 | 2004-12-02 | Davis Ralph A. | Nasal breathing apparatus |
US6971387B2 (en) * | 2003-09-19 | 2005-12-06 | Santa Barbara Medco | Personal air purifier |
TWM246616U (en) * | 2003-10-31 | 2004-10-11 | Jia-Hau Shiu | Improvement of assembling structure for eyeglasses |
US7055523B1 (en) * | 2005-02-24 | 2006-06-06 | Brown Thomas W | Internal nasal dilator and delivery mechanism |
US6978781B1 (en) * | 2005-03-11 | 2005-12-27 | John Jordan | Nasal dilator |
US20070219575A1 (en) | 2006-03-20 | 2007-09-20 | Mejia Marta L | Orthonostric device and method of forming the same |
US20090301499A1 (en) * | 2006-06-06 | 2009-12-10 | Robert Chalk | Device for alleviating snoring |
US20080053448A1 (en) * | 2006-08-31 | 2008-03-06 | Liska Regina B | Nasal filter |
US20080097517A1 (en) * | 2006-10-23 | 2008-04-24 | Webtec Converting, Llc. | External Nasal Dilator and Methods of Manufacture |
ITMI20062334A1 (en) * | 2006-12-05 | 2008-06-06 | Emilio Talmon | AIR FILTER FOR ENDONASAL APPLICATION |
SE530707C2 (en) * | 2006-12-27 | 2008-08-19 | Adactive Marketing Ab | nasal dilator |
US8641852B2 (en) * | 2007-02-06 | 2014-02-04 | Corbett Lair Inc. | Nasal dilator and methods of fabricating medical devices |
US8858587B2 (en) * | 2008-03-12 | 2014-10-14 | Corbett Lair, Inc. | Nasal dilator and method of manufacture |
US20090272386A1 (en) * | 2008-05-02 | 2009-11-05 | David Kurtz | Nose plug for preventing bruxism |
US20130118488A1 (en) * | 2011-11-14 | 2013-05-16 | Barbara Ledogar | Nasal Therapeutic System |
EP2877230A4 (en) * | 2012-07-27 | 2016-04-13 | Asap Breatheassist Pty Ltd | A device for improving air flow through a nasal cavity during physical activity such as sporting pursuits |
WO2014058740A1 (en) * | 2012-10-09 | 2014-04-17 | Weir Kenneth Ray | Nasal dilator |
WO2014183966A1 (en) * | 2013-05-13 | 2014-11-20 | Anthonius Fredericus Maria Bende | Nasal dilator |
US9486353B2 (en) * | 2014-03-26 | 2016-11-08 | Seattle Children's Hospital | Spring-biased nasal molding device |
-
2014
- 2014-06-27 US US14/317,840 patent/US20150005806A1/en not_active Abandoned
-
2019
- 2019-03-28 US US16/367,923 patent/US11166835B2/en active Active
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2672138A (en) * | 1950-09-05 | 1954-03-16 | Carlock Marion Pomeroy | Device to promote nasal breathing and prevent snoring |
US20060085027A1 (en) * | 2001-05-22 | 2006-04-20 | Sanostec Corp. | Nasal congestion, obstruction relief, and drug delivery |
US20070107731A1 (en) * | 2005-11-15 | 2007-05-17 | Reed Glen B | Clip-in nostril expander |
US20090248058A1 (en) * | 2008-04-01 | 2009-10-01 | Robert Kotler | Device and Method for Maintaining Unobstructed Nasal Passageways after Nasal Surgery |
US20090277459A1 (en) * | 2008-05-09 | 2009-11-12 | Jordan Innovation Center For Engineers And Industrial Enterprises Royal Scientific Society | Nasal Device Useful for Prevention of Snoring and Sleeping Apnea |
US9004071B2 (en) * | 2011-10-18 | 2015-04-14 | Ian Joseph Alexander | Nasal guide and method of use thereof |
US20140261459A1 (en) * | 2013-03-15 | 2014-09-18 | Fram Trak Industries | Antimicrobial nasal insert and method of manufacturing |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107928854A (en) * | 2017-11-13 | 2018-04-20 | 深圳市福生医疗器械有限公司 | A kind of harelip nose pillar retention clip |
USD991449S1 (en) * | 2019-01-16 | 2023-07-04 | Jon Garito | Rhinoplasty instrument |
WO2022076795A1 (en) * | 2020-10-08 | 2022-04-14 | New York University | Nasal molding device |
US20230008837A1 (en) * | 2021-07-06 | 2023-01-12 | CMH Lahore Medical College & IOD | Nasal Impression Assembly and Method of Measuring/Imprinting the Nasal Impression |
US11845206B2 (en) * | 2021-07-06 | 2023-12-19 | CMH Lahore Medical College & IOD | Nasal impression assembly and method of measuring/imprinting the nasal impression |
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US11166835B2 (en) | 2021-11-09 |
US20190282390A1 (en) | 2019-09-19 |
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