NONSURGICAL METHODS FOR NASAL MODIFICATION INCLUDING NASAL TIP ELEVATION AND/OR ELONGATION
20230077040 · 2023-03-09
Inventors
Cpc classification
A61B17/3468
HUMAN NECESSITIES
International classification
Abstract
Nonsurgical methods of modifying at least a portion of a nose of a subject, such as a tip of the nose of the subject, are provided herein. The method can include performing one or more of a first injection of a first filler composition and a second injection of a second filler composition. The first injection includes depositing the first filler composition in a first region defined as a septal space behind a middle crura and a medial crura of the nose, substantially level and/or above an anterior nasal spine of the nose, and in front of a caudal septal cartilage of the nose. The second injection includes depositing the second filler composition in a second region defined as the septal space behind the middle crura and the medial crura of the nose substantially level with the footplates of the nose and the columella segment of the medial crura of the nose.
Claims
1. A nonsurgical method of modifying at least a portion of a nose of a subject, the method comprising: performing one or more of: (i) a first injection of a first filler composition comprising: depositing the first filler composition in a first region defined as a septal space behind a middle crura and a medial crura of the nose, substantially level and/or above an anterior nasal spine of the nose, and in front of a caudal septal cartilage of the nose; and (ii) a second injection of a second filler composition comprising: depositing the second filler composition in a second region defined as the septal space behind the middle crura and medial crura and substantially level with footplate of the nose and the columella segment of the medial crura of the nose.
2. The method of claim 1, wherein the modifying comprises elevating a tip of the nose, elevating the columella of the nose, elongating the columella of the nose, elongating the tip of the nose, shortening the tip of the nose, increasing firmness of the nose, narrowing of a dome of the nose, elevating the footplates, decreasing width of an alar of the nose, increasing prominence of philtrum columns, increasing oblong shape of nostrils, or any combination thereof.
3. The method of claim 1, wherein first injection further comprises holding a columella of the nose, a nasal tip of the nose, or both in a first direction to extend open the septal space and/or the second injection comprises holding a columella of the nose, a nasal tip of the nose, or both in a second direction to extend open the septal space.
4. The method of claim 3, wherein the first direction is selected from the group consisting of an upward direction, a caudal direction, a rotated direction, and a combination thereof and/or the second direction is a distal direction, a caudal direction, an upward direction, or a combination thereof.
5. The method of claim 4, wherein the first direction is: (i) the upward direction and the nasal tip and columella are pressed against anterior septal cartilage of the nose and a tip of the nose is elevated; (ii) is the caudal direction and a tip of the nose is elevated, elongated, or both; or (iii) is the upward direction and the rotated direction and a tip of the nose and/or the nose is shortened.
6. The method of claim 4, wherein the second direction is a distal direction, a caudal direction, an upward direction, or a combination thereof.
7. The method of claim 1, wherein one or more of the following are satisfied: (i) the second filler composition is deposited in front of the anterior nasal spine; (ii) the first injection, the second injection, or both deposit the first filler composition, the second filler composition, or both prior to the first injection, the second injection, or both reaching the anterior nasal spine; (iii) first filler composition, the second filler composition, or both are deposited in the septal space of the nose; and (iv) the first filler composition is not deposited in a surface of a tip of the nose.
8. The method of claim 1, wherein each of the first filler composition and the second filer composition is deposited with a needle or a cannula.
9. The method of claim 1, wherein the first injection, the second injection, or both comprise a retro-injection or an antegrade injection and/or an amount of each of the first filler composition deposited and the second filler composition deposited is about 0.01 cm.sup.3 to about 2 cm.sup.3.
10. The method of claim 1, wherein the first injection, the second injection, or both enter the nose in one or more of the following areas: a tip region of the nose, between a middle crura, an infra-tip lobule, a supra-tip area, the columella region, an intra-nasal region, or an intra-oral region.
11. The method of claim 1, wherein a tip of the nose is elongated by greater than 0 mm to about 10 mm and/or the tip of the nose is elevated by greater than 0 mm to about 10 mm.
12. The method of claim 1, wherein the tip of the nose is not elevated and/or not elongated.
13. The method of claim 1, wherein the first filler composition and the second filler composition each comprises hyaluronic acid, calcium hydroxyapatite, autologous fat, heterologous fat, soft tissue, cartilage, bone, agar, agarose, collagen, dextran beads, polymethyl methacrylate (PMMA), methyl methacrylate, polylactic acid, bone powder of any origin, polydioxanone (PDO), silicone, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), a polyalkylimide, silk, human tissue, animal tissue, plant substrate, synthetic material or a combination thereof.
14. The method of claim 1, wherein the first filler composition and the second filler composition each are selected from the group consisting of a nonanimal stabilized hyaluronic acid (NASHA), a cross-linked nonanimal derived hyaluronic acid gel, an animal derived hyaluronic acid, a non-cross-linked hyaluronic acid product, and a combination thereof.
15. The method of claim 1, wherein the first injection, the second injection, or both are performed more than once and/or both the first injection and the second injection are performed.
16. The method of claim 15, wherein the first filler composition and the second filler composition are the same.
17. The method of claim 15, wherein the first filler composition and the second filler composition are different.
18. The method of claim 1, further comprising performing a third injection of a third filler composition comprising depositing the third filler composition in the radix region of the nose, a dorsum region of the nose, or both.
19. The method of claim 1, wherein the subject has one or more of: a nasal hump deformity, a saddle nose deformity, a nasal deformity caused by capsular contracture after a nasal implant.
20. The method of claim 1, wherein the subject is Asian, Caucasian, Hispanic, Arabian, African American, or a combination thereof.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations and are not intended to limit the scope of the present disclosure.
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[0047] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
DETAILED DESCRIPTION
[0048] Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific compositions, components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.
[0049] The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore specify the presence of stated features, elements, compositions, steps, integers, operations, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. Although the open-ended term “comprising,” is to be understood as a non-restrictive term used to describe and claim various embodiments set forth herein, in certain aspects, the term may alternatively be understood to instead be a more limiting and restrictive term, such as “consisting of” or “consisting essentially of.” Thus, for any given embodiment reciting compositions, materials, components, elements, features, integers, operations, and/or process steps, the present disclosure also specifically includes embodiments consisting of, or consisting essentially of, such recited compositions, materials, components, elements, features, integers, operations, and/or process steps. In the case of “consisting of,” the alternative embodiment excludes any additional compositions, materials, components, elements, features, integers, operations, and/or process steps, while in the case of “consisting essentially of,” any additional compositions, materials, components, elements, features, integers, operations, and/or process steps that materially affect the basic and novel characteristics are excluded from such an embodiment, but any compositions, materials, components, elements, features, integers, operations, and/or process steps that do not materially affect the basic and novel characteristics can be included in the embodiment.
[0050] Any method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed, unless otherwise indicated.
[0051] Although the terms first, second, third, etc. may be used herein to describe various steps, elements, components, regions, layers and/or sections, these steps, elements, components, regions, layers and/or sections should not be limited by these terms, unless otherwise indicated. These terms may be only used to distinguish one step, element, component, region, layer or section from another step, element, component, region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first step, element, component, region, layer or section discussed below could be termed a second step, element, component, region, layer or section without departing from the teachings of the example embodiments.
[0052] Spatially or temporally relative terms, such as “before,” “after,” “inner,” “outer,” “beneath,” “below,” “lower,” “above,” “upper,” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially or temporally relative terms may be intended to encompass different orientations of the device or system in use or operation in addition to the orientation depicted in the figures.
[0053] Throughout this disclosure, the numerical values represent approximate measures or limits to ranges to encompass minor deviations from the given values and embodiments having about the value mentioned as well as those having exactly the value mentioned. Other than in the working examples provided at the end of the detailed description, all numerical values of parameters (e.g., of quantities or conditions) in this specification, including the appended claims, are to be understood as being modified in all instances by the term “about” whether or not “about” actually appears before the numerical value. “About” indicates that the stated numerical value allows some slight imprecision (with some approach to exactness in the value; approximately or reasonably close to the value; nearly). If the imprecision provided by “about” is not otherwise understood in the art with this ordinary meaning, then “about” as used herein indicates at least variations that may arise from ordinary methods of measuring and using such parameters. For example, “about” may comprise a variation of less than or equal to 5%, optionally less than or equal to 4%, optionally less than or equal to 3%, optionally less than or equal to 2%, optionally less than or equal to 1%, optionally less than or equal to 0.5%, and in certain aspects, optionally less than or equal to 0.1%.
[0054] In addition, disclosure of ranges includes disclosure of all values and further divided ranges within the entire range, including endpoints and sub-ranges given for the ranges.
[0055] Example embodiments will now be described more fully with reference to the accompanying drawings.
[0056] Nonsurgical methods of modifying at least portion of a nose of a subject are provided herein. A method may include performing a first injection of a first filler composition, a second injection of second filler composition, or both the first injection and the second injection. The first injection may elevate a nose tip and the second injection may elongate a nose tip. The first filler composition and the second filer composition may be deposited with a needle or a cannula of any suitable size. For example, a 27 G, ½-inch needle may be used for subjects, such as Asian and African American subjects, and a 27 G, 1-inch cannula may be used for subjects, such as Hispanic and Caucasian subjects. Or in situations where required, the use of a needle or a cannula of any length and of any size can be used in a subject of any race.
[0057] Additionally, the first injection, the second injection, or both may include a retro-injection or an antegrade injection. A “retro-injection” refers to the depositing or ejection of the filler composition from a needle or a cannula as the needle or cannula is being removed or withdrawn from the nose, for example, from the septal space of the nose. An “antegrade injection” refers to the depositing or ejection of the filler composition from a needle or a cannula as the needle or cannula is entering the nose, for example, entering into the septal space of nose.
[0058] In any embodiment, prior to the first and/or second injection(s), any suitable topical anesthetic (e.g., lidocaine, pramoxine, etc.) may be applied to the area(s) surrounding the injection site of the subject. After a suitable amount of time, for example, about 5 to 25 minutes or more, the injection site and surrounding areas may undergo ice packing, for example, for about 2 minutes. Following skin disinfection, the first and/or second injection(s) may be performed.
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[0060] During the first injection, the needle or cannula may enter the nose 300, for example, at the mid-point cephalic to the middle crura 320 of the lower lateral cartilage 380, travel down to a mid-point between the columella 360 and the caudal septal cartilage (not shown) reaching the anterior nasal spine 330. The needle or cannula may travel down the potential space (septal space) in the middle between an anterior/caudal edge of the septal cartilage and the medial crura 350. After aspiration, a retro-injection may be carried out to deposit the first filler composition, stopping at the mid-level of the medial crura 350. Additionally or alternatively, the first filler composition may be deposited prior to the needle or cannula reaching the anterior nasal spine 330. It is also contemplated herein that an antegrade injection may be used during the first injection. In any embodiment, the first filler composition may not be deposited in a surface of a tip 370 of the nose.
[0061] In any embodiment, the first injection may further include holding the columella 360 and/or nasal tip 370 (also referred to as tip 370) of the nose in a first direction in order to extend open the septal space before, while, and/or after the first injection is performed. The first direction may be in an upward direction, a caudal direction, a rotated direction, or a combination thereof. For example, in order to provide an elevated nose tip and/or cephalic rotation, the columella 360 and/or nasal tip 370 may be held in an upward direction before, while, and/or after the first injection is performed. The injector may use the thumb and the middle fingers to hold the columella 360 while pulling slightly upward. Additionally or alternatively, the nasal tip 370 and columella 360 may be pressed against anterior septal cartilage of the nose to elevate the nasal tip 370. During the first injection, the septum structure may be distended and the nasal tip 370 can be elevated. The nasal tip structure itself may not be altered by the first filler composition because the first filler composition is not directly deposited on the nose tip, but the nasal tip does become elevated due to the lifting of the whole nasal tip structure. Additionally, the shape of the nasal tip does become better defined with a better shape as a result of the compression on it by the surrounding skin and tissue.
[0062] Additionally or alternatively, the first direction may be a caudal direction or downward and a tip of the nose may be elevated, elongated, or both. Additionally or alternatively, the first direction may be both the upward direction and the rotated direction and a tip of the nose and/or the nose may be shortened due to the nasal tip 370 undergoing rotation. It is also contemplated herein that if the nasal tip undergoes undesirable rotation, the columella 360 and/or nasal tip 370 may be held only in the caudal direction to offset the rotation.
[0063] Alternatively, the first injection may not further include holding the columella 360 and/or nasal tip 370 of the nose in a first direction.
[0064] In any embodiment, a nasal tip 370 may be elevated or lifted by greater than zero (0) mm, greater than or equal to about 0.25 mm, greater than or equal to about 0.5 mm, greater than or equal to about 0.95 mm, greater than or equal to about 1 mm, greater than or equal to about 2 mm, greater than or equal to about 3 mm, greater than or equal to about 4 mm, greater than or equal to about 5 mm, greater than or equal to about 6 mm, greater than or equal to about 7 mm, greater than or equal to about 8 mm, greater than or equal to about 9 mm, or about 10 mm; or from greater than zero mm to about 10 mm, greater than zero mm to about 8 mm, greater than zero mm to about 5 mm, greater than zero mm to about 3 mm, greater than zero mm to about 1 mm, about 2 mm to about 10 mm, about 2 mm to about 8 mm, about 2 mm to about 5 mm, or about 2 mm to about 4 mm. Alternatively, the nasal tip 370 may not be elevated or lifted, i.e., the nasal tip 370 may be elevated by zero mm. In order to measure nasal tip elevation, a first nasal tip height is measured prior to the first injection and/or the second injection, then a second nasal tip height is measured after the first injection and/or the second injection, and the difference between the first and second nasal tip heights is the nasal tip elevation. Nasal tip height is a measure of the highest point of the nasal tip (see
[0065] With regard to the second injection,
[0066] During the second injection, the needle or cannula may enter the nose 400, for example, through the nasal tip 370 above/cephalic to (e.g., about 2 to 5 mm above/cephalic to) the entry of the needle or cannula for the first injection, at a point of the anterior/caudal edge of the septal cartilage. The needle or cannula may travel down, going down the anterior edge of the septal cartilage aiming toward the anterior nasal spine 330, but without reaching the anterior nasal spine 330. After aspiration, a retro-injection may be carried out to deposit the second filler composition, stopping at a mid-level of the caudal septal cartilage 391 to avoid leaking through the scroll area onto the surface of the upper lateral cartilages 360. The second filler composition 410 may be deposited mainly at the footplate 340 and the columella segment of the medial crura 350. Additionally or alternatively, the second filler composition 410 may be deposited in front of the anterior nasal spine 330. After the second injection, the septal space structures may be distended and remain extended.
[0067] In any embodiment, the second injection may further include holding the columella 360 and/or nasal tip 370 (also referred to as tip 370) of the nose in a second direction in order to extend open the septal space before, while, and/or after the second injection is performed. The second direction may be of a caudal direction, an outward direction, an upward direction, or a combination thereof. For example, in order to provide an elongated nose tip, the columella 360 and/or nasal tip 370 may be held in an outward and/or caudal direction before, while, and/or after the second injection is performed. The injector may use the thumb and the middle fingers to hold the columella 360 while pulling away from the subject's head (e.g., in a caudal direction and/or outward direction). Additionally or alternatively, the nasal tip 370 and columella 360 may be held in an upward direction to elevate the nasal tip 370. After the second injection, the septal space between the septal cartilage and the medial crura may be inflated, and the whole nasal tip structure can extend in the sagittal plane, causing the nose tip to move either caudally (tip elongation) or anteriorly (tip elevation), or both, as directed by the injector's fingers. This effect mimics that of a bounce house, in which no column is present, yet the whole structure is easily bolstered up with the introduction of air.
[0068] Alternatively, the second injection may not further include holding the columella 360 and/or nasal tip 370 of the nose in a second direction.
[0069] In any embodiment, a nasal tip 370 may be elongated or lengthened by greater than zero (0) mm, greater than or equal to about 0.25 mm, greater than or equal to about 0.5 mm, greater than or equal to about 0.95 mm, greater than or equal to about 1 mm, greater than or equal to about 2 mm, greater than or equal to about 3 mm, greater than or equal to about 4 mm, greater than or equal to about 5 mm, greater than or equal to about 6 mm, greater than or equal to about 7 mm, greater than or equal to about 8 mm, greater than or equal to about 9 mm, or about 10 mm; or from greater than zero mm to about 10 mm, greater than zero mm to about 8 mm, greater than zero mm to about 5 mm, greater than zero mm to about 3 mm, greater than zero mm to about 1 mm, about 2 mm to about 10 mm, about 2 mm to about 8 mm, about 2 mm to about 5 mm, or about 2 mm to about 4 mm. Alternatively, the nasal tip 370 may not be elongated or lengthened, i.e., the nasal tip 370 may be elongated by zero mm. In order to measure nasal tip elongation, a first nasal tip length is measured prior to the first injection and/or the second injection, then a second nasal tip length is measured after the first injection and/or the second injection, and the difference between the first and second nasal tip lengths is the nasal tip elongation. The nasal tip length is measure by identifying and/or marking the rhinion (
[0070] In any embodiment, the first filler composition 310 and the second filler composition 410 may be deposited into the septal space of the nose 300, 400. For example, the first filler composition 310 and the second filler composition 410 may be deposited anywhere in the nasal septal space from the anterior nasal spine 330 to the columella 360, to the upper space behind the medial crura and to a tip part of the nasal tip cartilage.
[0071] However, the first filler composition 310 and the second filler composition 410 may not be directly deposited in between or close to the columella structure because it is believed that mimicking a columella strut with the filler does not work well for nose tip lifting. As far as vascular compromise is concerned, the injection site of the first and second filler compositions is far from the confluence of the six major blood supplies (the lateral nasal branch from angular arteries, columellar arteries, and nasal dorsal arteries) at the superficial layer (above the superficial musculoaponeurotic system, SMAS) of the tip. Hence, the methods described herein are safer.
[0072] In any embodiment, both the first injection and the second injection may be performed or stacked (first injection followed by the second injection and vice versa), for example, for a subject with short and flat nasal tips, thus achieving nasal tip elevation and elongation. Additionally or alternatively, the first injection, the second injection, or both may be performed individually each one, more than once or sequentially, for example, for a subject with substantial deficiency in the tip and canine fossa region. For example, the first and/or second injections may each be performed once followed by a period of time (e.g., 1 week, 2 weeks, 3 weeks, 1 month, 3 months, 6 months, 9 months, 1 year, etc.) and then performed again followed by the period of time, and so on, until the desired result is achieved.
[0073] In any embodiment, the first filler composition and the second filler composition may each comprise hyaluronic acid (e.g., Vycross® fillers, such as Juvederm® fillers, nonanimal stabilized hyaluronic acid (NASHA) fillers, such as Restylane® fillers, or any other hyaluronic acid fillers), calcium hydroxyapatite (e.g., Radiesse® fillers and any other brands or similar compositions), fat (autologous or heterologous fat), soft tissue of any origin, cartilage or bone products of any origin, agar, agarose, collagen, dextran beads, polymethyl methacrylate (PMMA), methyl methacrylate, polylactic acid, bone powder of any origin, polydioxanone (PDO) powder, PDO gel or any other form, silicone of any physical form, polytetrafluoroethylene (PTFE) in any form, expanded polytetrafluoroethylene (ePTFE), a polyalkylimide (e.g., hydrophilic polyacrylamide gel, such as Amazing Gel), silk in any form, any other human tissue (e.g., dermal tissue, AlloDerm® powders), animal tissue (e.g., porcine tissue, such as STRATTICE™ Reconstructive Tissue Matrix), plant substrate in any form (e.g., CollPlant substrates), any synthetic material, or any other suitable filler material, or a combination thereof. In some embodiments, the first filler composition and the second filler composition each may be a nonanimal stabilized hyaluronic acid (NASHA), a highly cross-linked non-animal hyaluronic acid gel (Vycross® fillers), a hyaluronic acid gel of more cross-linking, a hyaluronic acid gel of less cross-linking, a hyaluronic gel of animal origin, a cross-linked nonanimal derived hyaluronic acid gel, a hyaluronic acid product without any cross-linking, or a combination thereof. The first filler composition and the second filler composition may be the same or different.
[0074] The methods described herein allow for depositing the first filler composition and the second filler composition in smaller or larger amounts. For example, an amount of each of the first filler composition deposited and the second filler composition deposited may be greater than or equal to about 0.01 cm.sup.3, greater than or equal to about 0.05 cm.sup.3, greater than or equal to about 0.1 cm.sup.3, greater than or equal to about 0.25 cm.sup.3, greater than or equal to about 0.5 cm.sup.3, greater than or equal to about 0.75 cm.sup.3, greater than or equal to about 1 cm.sup.3, greater than or equal to about 1.25 cm.sup.3, greater than or equal to about 1.5 cm.sup.3, greater than or equal to about 1.75 cm.sup.3, or about 2 cm.sup.3; or from about 0.01 cm.sup.3 to about 2 cm.sup.3, about 0.01 cm.sup.3 to about 1.75 cm.sup.3, about 0.01 cm.sup.3 to about 1.5 cm.sup.3, about 0.01 cm.sup.3 to about 1.25 cm.sup.3, about 0.01 cm.sup.3 to about 1 cm.sup.3, about 0.01 cm.sup.3 to about 0.75 cm.sup.3, about 0.01 cm.sup.3 to about 0.5 cm.sup.3, about 0.01 cm.sup.3 to about 0.25 cm.sup.3, about 0.01 cm.sup.3 to about 0.1 cm.sup.3, about 0.01 cm.sup.3 to about 0.05 cm.sup.3, about 0.1 cm.sup.3 to about 2 cm.sup.3, about 0.1 cm.sup.3 to about 1.75 cm.sup.3, about 0.1 cm.sup.3 to about 1.5 cm.sup.3, about 0.1 cm.sup.3 to about 1.25 cm.sup.3, about 0.1 cm.sup.3 to about 1 cm.sup.3, about 0.1 cm.sup.3 to about 0.75 cm.sup.3, about 0.1 cm.sup.3 to about 0.5 cm.sup.3, or about 0.1 cm.sup.3 to about 0.25 cm.sup.3.
[0075] In further embodiments, the methods described herein may also include performing an optional third injection of a third filler composition. The third injection may include depositing the third filler composition in the radix region of the nose, a dorsum region of the nose, or both. The third filler composition may be the same as one or both of the first filler composition and the second filler composition. Alternatively, the third filler composition may be different from both the first filler composition and the second filler composition. The third filler composition may comprise hyaluronic acid (e.g., Vycross® fillers, such as Juvederm® fillers, nonanimal stabilized hyaluronic acid (NASHA) fillers, such as Restylane® fillers, or any other hyaluronic acid fillers), calcium hydroxyapatite (e.g., Radiesse® fillers and any other brands or similar compositions), fat (autologous or heterologous fat), soft tissue of any origin, cartilage or bone products of any origin, agar, agarose, collagen, dextran beads, polymethyl methacrylate (PMMA), methyl methacrylate, polylactic acid, bone powder of any origin, polydioxanone (PDO) powder, PDO gel or any other form, silicone of any physical form, polytetrafluoroethylene (PTFE) in any form, expanded polytetrafluoroethylene (ePTFE), a polyalkylimide (e.g., hydrophilic polyacrylamide gel, such as Amazing Gel), silk in any form, any other human tissue (e.g., dermal tissue, AlloDerm® powders), animal tissue (e.g., porcine tissue, such as STRATTICE™ Reconstructive Tissue Matrix), plant substrate in any form (e.g., CollPlant substrates), any synthetic material, or any other suitable filler material, or a combination thereof.
[0076] While nasal modifications including nasal tip elevation and elongation are described above, it also contemplated herein that the methods describe herein encompass the following further modifications and improvements: elevating the columella of the nose, elongating the columella of the nose, shortening the tip of the nose, increasing firmness of the nose, narrowing of the dome of the nose, elevating the footplates, decreasing width of an alar of the nose, increasing prominence of philtrum columns, modifying the shape of the nostrils (e.g., increasing oblong shape of the nostrils), or any combination thereof. Additionally or alternatively, the methods described herein may also result in an improved ratio of infra-tip lobule length to columella length. Referring back to
[0077] Table 1 below summarizes the observed benefits from performing the methods described herein.
TABLE-US-00001 TABLE 1 Benefits of filler injection into the septal space between caudal septal cartilage and columella cartilages. All benefits may not show in one case or in one treatment session. No. Benefits 1. Nasal tip elevated and firmer 2. Nasal tip elongation 3. Nasal tip could be downturned (with elongation) 4. Nasal tip rotation (upturn) to shorten a long nose 5. Nasal dome stands out, and narrower 6. Finer tip cartilaginous structures 7. Columella lengthened 8. Footplates elevated 9. Infra-tip lobule to columella ratio improved 10. Nostrils change to oblong in shape 11. Alar width reduced 12. Nasal tips do not become bigger, as other injection techniques would 13. Philtrum columns become more prominent 14. Nasolabial Angle and veiling improved 15. Upper lip shortened 16. Lip better positioned 17. Depressor septi nasi function eliminated with better looking smiles 18. Gummy smile/labial incompetence improved 19. Works as a tissue expander—successive injections generate progressive improvements 20. Salvages botched nasal implant result, especially with capsular contracture 21. Acts as the key in facial profile improvement 22. It is useful for all races
[0078] The methods described herein advantageously may be useful in treating a subject having one or more of a nasal hump deformity, a saddle nose deformity, a nasal deformity caused by capsular contracture after a nasal implant. Furthermore, the methods described herein may be performed on a subject that is Asian, Caucasian, Hispanic, Arabian, African American, or a combination thereof.
[0079] Without being bound by theory, it is believed that the methods described herein are not based on a columella strut effect. Rather, the first and second filler compositions are injected into the septal space, which may be further extended by holding and pulling away the columella and/or nose tip, to obtain a significant elevating and/or elongating effect. The anterior nasal spine need not be reached during the injections with the described methods. To the contrary, if the filler compositions are injected between the medial crura or in their vicinity, the columella may become constrained and the lifting effect may be limited. This constraint on nasal tip lifting may be due to the distension of the columella and surrounding fibrous structures resulting in the “tie up” of the columella per se for mechanisms unknown. However, in the methods described herein, the filler composition distends the potential septal space between the mucosal septum only in the sagittal direction, and the sagittal expansion of the space produces an “inflated bounce house” effect. This may be attributable to the abundance of the dense fibro-fatty tissue network, which tightly holds the membranous septum and the cartilages in a relatively volume-constrained space. Because the septal cartilage is fixed and the columella is not tied up, the “inflated bounce house” effect freely elevates or distends the columella and tip structures.
[0080] Lee et al. reports that a significant amount of densely packed elastin, collagen fibers and fatty tissues are present in the space between the caudal septal cartilage and the medial crura. Lee M. R. et al., Soft-Tissue Composition of the Columella and Potential Relevance in Rhinoplasty. Plast Reconstr Surg 2014; 134:621-625. Without being bound by theory, it is believed that it is the cartilaginous framework and supporting soft tissues, together, which create a construct responsible for ultimate tip conduct. It is further suggested that the combined influences of cartilaginous structure and accompanying soft tissue together determine nasal tip projection and position. It is believed that it is the dense fibro-fatty network that forms the foundation for the superior effectiveness of the methods disclosed herein.
[0081] Additionally, and without being bound by theory, the disclosed methods' effectiveness may depend on various mechanical effects as follows: [0082] 1) The initially deposited filler composition sits on the center of a dense layer of fibro-fatty tissue network, which acts as a “hammock” that supports the filler and with more influx of filler, the filler starts to push the fibro-fatty tissue above and in front of it, upward or caudally, as directed by the injector's hand. [0083] 2) The integrity of the fibro-fatty tissue network holds the septal mucosa tightly together, preventing lateral expansion of the membranous mucosa under the pressure of the filler bolus. Because of this, and the septal cartilage being fixed, the inflated “bounce house” effect can only lead to the rising or elongation of the “free” nasal tip structures.
EXAMPLES
[0084] In the examples below, the patients' ages spanned from 18 to 84, with most of the patients in the range of 25 to 60. There were 17 male patients included in this study. Among the Asian patients, 78 patients only required pure tip elevation effect and 35 needed only tip elongation. The majority needed both tip elevation and elongation at the same time (674 treated with the first injection technique described above (also referred to as “tip-lift injection technique), 156 treated with the second injection technique described above (also referred to as “tip-elongation technique”), and 189 with a stacking of both techniques). The need for both tip elevation and elongation effects was demonstrated even in many patients with relatively long noses because after tip lifting, the cephalad rotation visually shortens the noses, requiring simultaneous tip elongation for more aesthetically pleasing results. The treatment time was 2 to 10 minutes for a nose makeover. Depending on the patients, the amount of filler used was from 0.4 to 0.8 cc for either nose tip-lift technique or nose tip-elongation technique. The filler used was Restalyne® Lyft (Galderma). The nose tip was elongated by 2 mm to 6 mm (mean value 3.13 mm, measured from the rhinion to tip defining points), and the nose tip was elevated by 2 mm to 8 mm (mean value 5.07 mm, measured from the tip to the nasolabial junction). Yet, even in those patients with limited tissue expandability, when serial injections of the nose tip were carried out, the nasal tip elevation and elongation was further improved. Hence, serial injection seemed to be a useful tool for “tissue expansion” with the filler in the septal space over time
Example 1
Method of Nose Tip-Lift Injection Technique
[0085] This example demonstrates the treatment effect of a patient with significant nasal tip deficiency. An amount of 0.6 cm.sup.3 of filler was injected in the tip region with the tip-lift technique and 0.4 cm.sup.3 for the radix and the canine fossa. As shown in
[0086] The nasolabial angle improvement came naturally with the distention of the lower part of the septal space between the caudal septum and the columella. With the tip raised from below, the nasal skin and soft tissue became tense, pressing on the tip cartilaginous structures and making them more compact together, showing better tip defining points. Additionally, because the tip was elevated without the piling on of filler on the top, the tip remained natural, while the columella was lengthened. Subsequently, the infra-tip lobule length to columella length ratio was better. Next, the nostril was changed to a better shape, becoming oblong and standing up, instead of being low lying and flat. The alar width was narrowed as a result of the gathering of tissue more centrally. After all these changes, the nose became smaller from the frontal view.
[0087] Note that the philtrum columns became more prominent, the upper lip became shorter, and hanging nose was corrected with this simple tip lift injection. Aging is accompanied by effacement of philtrum prominence and upper lip lengthening. Correcting these features was very welcoming in aging patients. Daniel et al. described their findings in the study of human nasal base anatomical structures and analyzed in detail as to the functionality and the possible inter-play of these previously ignored structures. Daniel, R. K., et al., The Lower Nasal Base: An Anatomical Study Aesthetic Surgery Journal 2013; 33:222-232. More in-depth studies were done to dissect the nasal ligaments and relevant structures. Daniel, R. K., et al., The Nasal Ligaments and Tip Support in Rhinoplasty: An Anatomical Study Aesthetic Surgery Journal 2018, Vol 38(4) 357-368. A diagram shown in
Example 2
Method of Nose Tip-Elongation Injection Technique
[0088] This example demonstrates the treatment of patients with significant nasal tip length deficiency. An amount of 0.7 cm.sup.3 of filler was injected in the tip region with the tip-elongation technique and 0.3 cm.sup.3 in the radix and the glabella region to better connect the nose with the brow structures. The effects show both tip elevation and elongation. Another 1 cm.sup.3 of the filler was injected in the canine fossa area.
[0089] In another patient, 0.8 cm.sup.3 of filler was used for injection with the nose tip-elongation technique and 0.2 cm.sup.3 w of filler as used for canine fossa augmentation. The results are shown in
[0090] Shown in
[0091] Bolus injection into the middle of the potential septal space between the caudal septum and the columella can generate both lifting and elongation effects of the tip, albeit the elongation effect is modest. When more elongation is desired, this nose tip-elongation technique is employed, with the needle inserted in a more cephalic position on the nasal tip skin, hugging the caudal septal cartilage. The closer the needle to the septal cartilage, the better the elongation effect.
[0092] The same is true when nose tip-elongation injection is performed. Some degree of tip lifting effect is also achieved, and this effect is controllable with the injector's non-dominant hand, by manipulating the pressure on the nose tip. Regarding nose tip elongation: 1) it can be a difficult task to elongate a nose, even with rib cartilage for surgical rhinoplasty; and 2) the current study involves more than 1000 cases that demonstrated effectiveness of nose elongation in most of them.
Example 3
Method of Nose Tip-Elongation and Tip-Lift Injection Techniques for Small Noses
[0093] This example demonstrates the treatment of patients with significant “small nose” deficiency. Extremely small noses pose a unique challenge to the treating physicians, because the heights of the tip, the dorsum and the radix all need to be corrected at the same time. With conventional filler injection methods (augmentation of the anterior nasal spine, creation of columella strut with a filler, and/or sometimes, augmenting the tip with a filler), due to the limitation in achieving tip elevation height, these patients typically could only obtain limited aesthetic results. However, with the nose tip-lifting and nose tip-elongation method disclosed herein, it becomes much easier because the filler injection with the two techniques can be stacked. The patient in
Example 4
Method of Nose Tip-Lift Injection Techniques for Long Noses
[0094] This example demonstrates the treatment of a patient with significant long nose deformity. Due to the relatively lower tip height of the Asian noses, most of the long noses can be manipulated with the tip injection to make them shorter by up turning the tips. The injection was focused on lifting the tip and at the same time, the injector's non-dominant hand pushed the whole tip structure and the upper half of the columella in a cephalic direction. A total volume of 0.8 cm.sup.3 of filler was injected for injection with the nose tip-lift technique and 0.2 cm.sup.3 of filler was injected in the canine fossa. As shown in
Example 5
Method of Nose Tip-Lift Injection Techniques for Hanging Noses
[0095] This example demonstrates the treatment of a patient with significant hanging nose deficiency. These patients demonstrate hanging noses, especially when smiling, causing the nose tip height to be pulled even lower, with further narrowing of the nasolabial angle. The culprit worsening the nose hanging effect is the activation depressor septi nasi muscles. This effect was corrected by the tip lift injection method using 0.7 cm.sup.3 of filler and 0.3 cm.sup.3 of filler was delivered in the canine fossa, as shown in
Example 6
Method of Nose Tip-Lift Injection Techniques for “Large” Noses
[0096] This example demonstrates the treatment of patients with a significant large nose deficiency. These patients typically have a flat, round and bulbous tip, with wide alar widths. A total volume of 0.8 cm.sup.3 of filler was injected for injection with the nose tip-lift technique, 0.2 cm.sup.3 of filler was injected in the radix, and 1 cm.sup.3 of filler was injected in the canine fossa.
Example 7
Method of Nose Tip-Lift and Tip-Elongation Injection Techniques for Nasal Humps
[0097] This example demonstrates the treatment of patients with significant nasal hump deficiency. In the past, most of these patients would have required surgical correction. But the current effective nose tip-lift and tip-elongation injection techniques make it possible for most of these patients to avoid surgeries. The patient in
[0098] The patient in
Example 8
Method of Nose Tip-Lift and Tip-Elongation Injection Techniques for Saddle Nose Deformities
[0099] This example demonstrates the treatment of patients with saddle nose deformities. There are plenty of publications describing the treatment of saddle nose deformity using fillers. However, most of these treatment modalities are focused on camouflaging the saddle deformity alone. In most of these deformed noses, covering up the deformity alone is certainly not enough, due to the profound accompanying tip deficiency. The patient in
Example 9
Method of Obtaining Progressive Changes with Nose Tip-Lift and Tip-Elongation Injection Techniques
[0100] This example demonstrates the treatment of patients with serial injections in the nasal tip to obtain progressive improvements. Often, there is the insufficiency of soft tissue envelop when a significant improvement is desired. Additionally, the mobility of the tip could be inadequate. After the first injection, the swelling usually settles by 1 week. In the following few weeks, some of the fillers will dissipate into the surrounding tissues, losing some supporting effect. As a result, patients are asked to come back for a second enhancement at 3 weeks to 3 months. During this second injection (or second enhancement or treatment), the filler used for tip may only be half as much. It is after this second enhancement, the result may become more stable. The third enhancement may be at a 9-month to 1 year interval.
[0101] The patient in
[0102] The patient in
[0103] Oftentimes, the filler improvement of a nose is significantly limited by the availability of soft tissue envelop. Interestingly, a “tissue expansion” phenomenon was observed.
Example 10
Results Showing the Longevity with the Methods of Nose Tip-Lift and Tip-Elongation Injection Techniques
[0104] This example demonstrates the longevity of filler with the methods of nose tip-lift and tip-elongation injection techniques. The patient in
[0105] The patient in
[0106] Again,
[0107] The patient in
Example 11
Results Showing the Effectiveness with the Methods of Nose Tip-Lift and Tip-Elongation Injection Techniques for Contracted Short Noses Troubled with a Nasal Implant
[0108] The patient in
Example 12
Results Showing the Effectiveness with the Methods of Nose Tip-Lift and Tip-Elongation Injection Techniques in Other Races
[0109] Other races can also be satisfactorily treated with the aforementioned nose tip-elongation and nose tip-lift injection methods. Shown in
[0110] All publications, patent applications, issued patents and other documents referred to in this specification are herein incorporated by reference as if each individual publication, patent application, issued patent, or other document was specifically and individually indicated to be incorporated by reference in its entirety. Definitions that are contained in text incorporated by reference are excluded to the extent that they contradict definitions in this disclosure.