MX2008002537A - Surgical scaffold - Google Patents

Abstract

A scaffold for reshaping an ear or a nose, the scaffold being configured to be i) attached to the cartilaginous portion of an ear or ii) attached to the cartilaginous portion of a nose, wherein the scaffold is formed at least in part from a shape-memory material and/ or a plastic material and is capable of transforming from a first configuration to a second, pre-programmed configuration.

Description

SURGICAL SCAFFOLD The present invention relates to a scaffold for reshaping an ear or nose of an animal, preferably a human, wherein the scaffold, at least in part, is formed from a shape recovery material or a material plastic. The prominent deformity of the ears and nose is common among the human population. First, the problem of ear deformity will be considered. An ear, which projects more than 17 mm from the side of the head, is usually perceived as prominent. By this estimate, up to 5% of the population can be affected. Both ears are commonly affected although, occasionally, only one side is prominent. The prominence may be the result of a deficiently formed or absent antihelical fold (Figures 1 and 2). Or it may be the result of a deep atrial fossa (Figures 1 and 3). Alternatively, both abnormalities may need to be addressed when prominent ears are corrected. There are a number of known methods to address the problem of prominent ears. These methods can be divided into two categories, those that involve otoplastic surgery (a procedure to change the shape of the ear) and those that avoid surgery. Examples of each of these categories will now be discussed briefly.

A series of operations (otoplastic surgery) are available to correct the deformities of the ears. These vary from very invasive procedures to reshape cartilage, to minimally invasive procedures. The principle involved in all these procedures is the reshaping of the cartilage, which gives the ear its prominence. Otoplastic, invasive, standard surgery is a prolonged procedure, which takes approximately 90 minutes (45 minutes for an ear). A large number of complications has been associated with this type of surgery. These include: problems with infection, bleeding, epithelial necrosis, death by general anesthesia, recurrence of prominence, keloid or hypertrophic scarring, asymmetry, palpable sharp edges (where the cartilage has been cut), pain, numbness and intolerance / sensitivity to cold . Minimally invasive otoplastic procedures (using needles or similar instruments) to reshape cartilage have fewer complications and take less time (15 minutes for each ear), but are also less successful in achieving ear prominence corrections. Asymmetry and palpable sharp edges are also more common compared to standard otoplastic surgery.

A further disadvantage of both standard otoplastic surgery and minimally invasive otoplastic procedures is that surgeons must undergo lengthy and expensive training to learn the relevant surgical techniques. Additionally, the results of the first 10-20 cases are likely to be unpredictable. Currently there are no means by which this can be avoided. To avoid some of the problems associated with otoplastic surgery, several devices have been developed to correct prominent ears, which avoid surgery altogether. An example of such a device is known as Earbuddies ™. At birth and for a subsequent variable time (up to six months), the cartilage of the human ear remains soft and deformable. Therefore, external forces applied to the cartilage can result in permanent changes to its conformation. After six months, the cartilage becomes firmer and more resistant to deformation. In the first years of life, the Earbuddies ™ takes advantage of the deformability of the cartilage. A piece of soft wire coated in silicone (for comfort) is molded and placed on the outer side of the ear, and sticked with adhesive tape in position (Figures 4a to 4c). The cartilage molds its conformation to that of accompanying the ear and any prominence is corrected. More information about how the device is used is available from the website for the device at http: // www. earbuddies co. uk / pws / index. htm Earbuddies ™ are very successful when used in children up to about 6 months of age. Later, the cartilage becomes firmer, and the amount of time the splint needs to remain in place to exert an effect makes it impractical to use. This is aggravated by the growing skill of the child, who will try (and will usually succeed in) removing the splint, thereby reducing its effectiveness. An alternative device, which avoids the need for surgery, is known as Auri®Clip. The Auri® Clip applies external pressure, smooth, continuous, to the cartilage of the ear in the region of the anti-helical fold (Figures 1, 5, 6). This deforms the cartilage in this area for a prolonged period of time to make the ears bear more pairs on the head. The Auri®Clip is part of the patented Auri®Method, which consists of three products: i) The Auri®Clip. ii) The Auri®Strip, a special poultice. iii) The Auri®Protective Spray. According to the manufacturer, the Auri®Clip is a clamp that measures 2.5 cm (1 inch) on all sides, the which is fixed to the ear during the night or day (Figures 5a and 5b). It consists of three parts: the part behind the ear, the part in front of the ear and a lock. The Auri®Strip is a transparent, double-sided medical adhesive material, very thin (0.2 mm thick), which is invisible when worn and can also be used to reshape the anti-helical fold (Figures 6a to 6c). The Auri®Protective Spray is used together with the Auri®Clip and Auri®Strip to avoid problems with skin irritation due to prolonged use of the Auri®Clip. Producers claim that 3 to 6 months of treatment are enough to have a permanent effect. More information about the use of the device is available from http: // www. aurimethod. com / index .htm. This technique has the disadvantage that fasteners cause skin irritation in some patients. Additionally, correction of deformities may not be complete. Nose deformities are also common in the human population. Deformities of the nose include, for example, having a broad tip, forked tip or split point. Rhinoplasty (nose shaping surgery) has been conventionally used to treat these deformities. Noses can be made smaller by using reduction rhinoplasty, or lengthened by using rhinoplasty augmentation. Such Surgery usually involves separating the skin from the nose of its bone and cartilage support frame. In conventional rhinoplasty, both bone and cartilage may need to be reshaped. The bone, which forms approximately one third of the nose, is relatively easy to reshape. In contrast, cartilage, which forms the remaining two thirds, is relatively difficult to reshape. This is particularly true for the tip of the nose. There are several disadvantages of conventional rhinoplasty. For example, traumatic dissection of the nose can damage the nasal cartilages. There is also a risk of epithelial necrosis. Additionally, the asymmetry may be worsened by surgery. Cartilage grafts are often scarce, especially in the revision procedure and in cleft tip noses. Additionally, the operations are often prolonged and the surgeon must be highly experienced. The training of a sufficiently experienced surgeon to perform rhinoplasty is slow and expensive. Moreover, there are disadvantages of conventional rhinoplasty for the patient. The operation can be painful and there is a risk of adverse reaction, or even death, due to the general anesthetic. Additionally, the results of the surgery can be unpredictable and irregularities can be observed, particularly at the tip or back. There is also a risk of recurrence of the deformity. The present invention aims to address at least some of the problems and disadvantages of the prior art. According to a first aspect of the present invention, a scaffold is provided to reshape an ear or a nose, the scaffold is configured to be i) attached to the cartilaginous portion of an ear or ii) attached to the cartilaginous portion of the nose , wherein the scaffold, at least in part, is formed from a shape and / or plastic material recovery material, and is capable of being transformed from a first configuration to a second preprogrammed configuration. Preferably, the scaffold for reshaping an ear or a nose comprises a body portion and at least one coupling member for engaging the cartilaginous portion of an ear or nose, wherein the scaffold, at least in part, is form from a shape recovery material and / or a plastic material, and is capable of being transformed from a first configuration to a second preprogrammed configuration. In a second aspect, the present invention provides a method for reshaping an ear or a nose comprising providing scaffolding as described herein. above, inserting at least part of the scaffold into an ear or nose and altering the scaffold to cause the scaffold to transform from its first configuration to its second preprogrammed configuration. In a third aspect, the present invention provides an applicator for inserting the scaffold, as defined herein, into an ear or nose, the apparatus comprises means for releasably retaining the scaffold, and means for deploying the scaffold in the ear. or nose By the term "scaffolding", as used herein, is meant any biocompatible structure or frame, which can be used to reshape an ear or a nose. Preferably, with implantation in a patient, the scaffold does not react adversely with a patient. The scaffolding may be suitable for reshaping the anti-helical folds of the ear, and / or for reshaping the atrial fossa of the ear. The scaffold for reshaping an ear or nose may comprise a body portion and at least one coupling member for engaging the cartilaginous portion of an ear, or for engaging the cartilaginous portion of a nose, respectively.

The body portion of the scaffold for reshaping an ear or a nose may have the shape, or substantially the shape, of a rectangle, a square, a rhombohedron, a circle or other regular or irregular polyhedron. If the shape of the body portion has corners, it may be favorable to round off the corners or edges, or otherwise alter them so that there are as few sharp corners / edges as possible. The body portion can be symmetric or asymmetric. Preferably, the body portion of the ear scaffold will be 0 to 35 millimeters long, 0 to 10 millimeters wide and 0 to 2 millimeters thick. More preferably, it will be 5 to 25 millimeters long, 5 to 9 millimeters wide and 0.2 to 1.8 millimeters thick. More preferably, it will be 10 to 20 millimeters long, 4 to 8 millimeters wide and 0.5 to 1.5 millimeters thick. Preferably, the body portion for the nose scaffold will be an irregular polyhedron. Preferably, the body portion of the nose scaffold will have a length of 20 to 35 millimeters, width of 0 to 15 millimeters and a thickness of 0 to 2.5 millimeters. More preferably, the body portion for the nose scaffold will have a length of 25 to 30 millimeters, a width of 5 to 10 millimeters and a thickness of 0.5 to 2.0 millimeters. Preferably, the coupling member for coupling in the cartilaginous portion of an ear is of adequate dimensions to fit into the cartilaginous portion of an ear, without the risk of projecting through the skin of the ear. Similarly, the coupling member to be attached to the nose will preferably be of a suitable size to fit into the nasal cartilage, but without the risk of projecting through the skin. It will be understood, by the experienced person, that the appropriate dimensions can vary with the size of the ear or nose in which the scaffold will be implanted. Therefore I could vary for a child and for an adult. Preferably, the coupling member has dimensions less than, or equal to, the cartilaginous portion of the ear or nose. Preferably, the coupling members for coupling in the atrial cartilage will be 0 to 5 millimeters long and 0 to 1.5 millimeters in diameter. More preferably, the coupling members for coupling in the atrial cartilage will be 1 to 4 millimeters long and 0.5 to 1 millimeter in diameter. Preferably, the coupling members for coupling in the nasal cartilage will be from 0 to 5 millimeters and from 0 to 1.5 millimeters. More preferably, from 1 to 4 millimeters in length and from 0.5 to 1 millimeters in diameter. The coupling members, in a particular body portion, may have the same length and / or width than another of the coupling members in a given body portion. Alternatively, at least one of the coupling members may have a different length and / or width than another coupling member in a given body portion. Preferably, all coupling members in a particular body portion will be of equal length and / or width in their entirety. The coupling members of the present invention may be, for example, in the form of spikes, spikes, barbs or cylindrical or branched protuberances. Preferably, the scaffold comprises a plurality of coupling members extending from the body portion. The number of coupling members per body portion can be varied depending on the deformity that is being corrected. Preferably, the body will have at least two coupling members, more preferably it will have at least four, more preferably at least six. The coupling members may be arranged symmetrically or asymmetrically in the body portion. The coupling members can be placed, in their entirety, on the face of the body portion. Alternatively, at least one of the coupling members may protrude from a different face of the body portion. The coupling members can be positioned towards the edge of the body portion, or / and towards the center of the body portion. The scaffold for reshaping an ear or nose of the present invention may comprise a body portion without coupling members. Such a scaffold can be held in the desired position in the ear or nose, for example, by the overlying skin. It may be favorable that a scaffold without coupling members be used in the present invention, since this may simplify the application and / or removal of the scaffold to / from the ear or nose. Preferably, when the scaffold of the present invention is placed on the anterior surface of the ear, the scaffold is without coupling members. In one embodiment of the present invention, it is favorable that a substantial part of the scaffolding body has a substantially smooth surface. This allows the scaffold to be easily deployed on, or removed from, the nose or ear. In this embodiment, it is preferable that the body does not comprise coupling members. When coupling members are not present in the scaffolding, it has been found favorable that the scaffolding body has a width of less than 10 millimeters, preferably less than 5 millimeters and more preferably less than 3 millimeters. The length of the body preferably is greater than 10 millimeters, more preferably greater than 12 millimeters and more preferably less than 15 millimeters. Without wishing to be limited by any In theory, it has been found that, when the scaffolding length is less than 10 millimeters and there are no coupling members, the friction forces between the cartilage and the scaffolding are not sufficient to allow the cartilage to grind cartilage satisfactorily. . In a further embodiment of the present invention, the scaffold body is designed so that the frictional contact between the scaffold and the cartilage, when in place in the nose or ear, is increased as compared to a scaffold which has a substantially smooth surface. This can be achieved, for example, by designing the scaffold, so that at least a portion of the scaffold surface has a rough surface. In order to facilitate the application of such modality, the scaffold can be designed so that only a portion of the scaffold has a rough surface and the remaining portion is smooth. Preferably, the central portion of the scaffold has a rough surface and the edge portions are substantially smooth to allow easy deployment of the scaffold in the nose or ear (see, for example, Figure 18b). Preferably, the body portion of the scaffolding tapers to narrow at one end. More preferably, the body portion will taper to a narrower main end, and will have a wider posterior end. The extreme The main one is designed so that it is inserted first in the patient. The scaffolding of the scaffold preferably decreases the lateral damage done to the skin when the scaffold is inserted or removed. The edges of the scaffold can be straight, curved, wavy, serrated or a combination. It may be favorable that the edges are not straight, so that the edge engages with the skin and provides more anchorage of the scaffold to the cartilage. It will be understood that the scaffold for reshaping an ear or nose can be designed to remain in the patient's body for a substantial amount of time, for example, at least two years, or more preferably at least five years. Alternatively, the scaffold may be designed to be removed from the patient after, for example, less than two years, or less than one year, or less than six months. The scaffolding of the present invention, at least in part, is formed from a shape recovery material and / or a plastic material, and is capable of being transformed from a first configuration to a second preprogrammed configuration. The first and / or second configuration of the scaffold may be in a forced or unforced state. Preferably, the first configuration is in a forced state and the second configuration is in an unforced one or vice versa. Preferably, any of the first or second preprogrammed configuration is substantially curved and the other configuration is substantially straight. Preferably, the first and / or second configuration of the scaffold is preprogrammed to conform to the shape of the ear or nose. For example, it can be preprogrammed to be substantially in the form of, or at least part of the shape of, an anti-helical fold, an atrial fossa, or a nasal cavity. · Preferably, the body portion, and / or at least one coupling member, at least in part, can be formed from the shape recovery material and is capable of being transformed from a first configuration to a second preprogrammed configuration . The term "shape recovery material" is well known in the art. As used herein, the term can be defined as a material which is capable of being transformed from a first configuration to a second preprogrammed configuration. This can be initiated by a change in temperature. The shape recovery material of the present invention can be a metal alloy or a shape recovery polymer.

Preferably, the alloy used is a nickel-titanium-shaped recovery alloy. More preferably, the alloy comprises approximately 50% nickel and 50% titanium by weight of the total composition. Preferably, the nickel-titanium alloy used in the present invention is of the type described in US Pat. 3,174,851, which is known as "Nitinol". Details of such materials can be found in NASA Publication SP 5110 titled "55-NITINOL" - The Alloy with a Memory, Its Physical Metallurgy, Properties, and Applications, CM. Jackson et al; 1972. Many other materials that have similar characteristics are well known. The property of nitinol, which can be exploited in the present invention, is the ability to preprogram a particular shape in the metal alloy and activate the "memory" in this way by heating / cooling it to specific temperatures. Using this property, it is possible to control the point at which the nitinol changes shape to within 1 to 10 ° C, preferably within 1 to 5 ° C and more preferably within 1-2 ° C. Preferably, the temperature range over which the scaffold changes from the first to the second, and / or the second to the first configuration, is narrow. The scaffolding of the present invention can understand a plastic material, which can be thermoplastic. This material can be biodegradable. Additionally, it can have shape recovery properties. Preferably, the scaffold comprises a plastic material which is a biodegradable and / or bioabsorbable elastomer with shape recovery properties. Examples of such materials can be found in Medical Device Technology, April 2005. Examples of such materials include, but are not limited to, poly (e-caprolactone) or those based on crystallizable macrodial, which can be synthesized from poly (p. -dioxanon) diols and poly (e-caprolacton) diol. The scaffold of the present invention may comprise a bioabsorbable or biodegradable material, which may be a polymer or a copolymer. Examples of bioabsorbable materials which may be used in the present invention include, but are not limited to, synthetic materials such as polyacetic acid, polyglycolic acid, polydioxanone, polytrimethylene carbonate, poly (ethylene carbonate), poly (iminocarbonate), polycaprolactone, polyhydroxybutyrate, polyalkylene oxalates, polyalkylene succinates, poly (maleic acid), poly (1,3-propylene malonate), poly (ethylene terephthalate), poly (amino acids) and VICRYL ™ (a bioabsorbable copolymer of glycolide and lactide) .

Preferably, the bioabsorbable material is a polydioxanone homopolymer. It will be understood that the selection of a suitable absorbable material will depend on such factors, as required, the in vivo resistance properties and desired absorption rate for the scaffold. One aspect of the present invention provides a method for reshaping an ear or nose comprising providing a scaffold as described herein, introducing at least part of the scaffold into an ear or nose and altering the scaffold to cause the scaffolding is transformed from its first configuration to its second preprogrammed configuration. Preferably, the present invention provides a method for reshaping an ear or nose comprising providing a scaffold, wherein the scaffold comprises at least one coupling member as described herein, introducing at least one coupling member of the scaffold. scaffolding in a cartilaginous portion of an ear or nose, and altering the scaffold to cause the scaffold to transform from its first configuration to its second preprogrammed configuration. Preferably, the temperature of at least a part of the scaffold is altered to cause the scaffolding to transform from its first configuration to its second preprogrammed configuration. Alternatively or additionally, scaffold strength can be applied or released to transform the scaffold from one configuration to another. The scaffold temperature can be increased or decreased to cause the scaffold to transform from its first configuration to its second preprogrammed configuration. It will be understood that the desired temperature ranges, for the transition of the scaffold from one configuration to another, can be determined by the tolerance of the animal / human tissue to heating and cooling, and to the temperature fluctuations experienced in the nose and ear during daily life. . Preferably, the scaffold temperature of the present invention will remain from -20 ° C to 45 ° C, more preferably from 0 to 42 ° C, more preferably from 15 to 40 ° C. It is known that exposure of animal / human tissue for prolonged periods (greater than 1 minute) at temperatures above 40 ° C, can result in permanent damage to tissues, and prolonged exposure (hours) of the entire organism at temperatures Above this level is usually not compatible with life. By way of Similarly, exposure of animal / human tissue for prolonged periods to temperatures below zero is prone to damaging the tissue and can lead to freezing in some cases. In this way, prolonged exposure of the tissues to extreme temperatures of preference is avoided or minimized. In one embodiment, wherein the scaffold comprises a body portion and at least one coupling member, the present invention provides a method comprising introducing at least one scaffolding coupling member into the cartilaginous portion of an ear or nose. when the scaffold is at an elevated temperature, and where the scaffolding is transformed from its first configuration to its second preprogrammed configuration as the scaffold cools below a predetermined temperature. Preferably, the scaffold of the present invention is in a first configuration at room temperature (for example 20 to 25 ° C) and at animal / human body temperature (for example 35 to 40 ° C). The first configuration can be curved. By heating the scaffold above the temperature of the animal or human body to, for example, around 41 to 42 ° C, the scaffolding becomes a second preprogrammed configuration. The second configuration can be substantially straight. The scaffolding it can then be inserted into the animal or human while the scaffold is in its second configuration. Inserting the heated scaffold may take only a few seconds, thus tissue damage is limited. Once the scaffold has been inserted into the cartilage of the ear or nose, it can be cooled quickly, for example, by soaking with water. Upon cooling, the scaffolding is preprogrammed to become its first configuration and to subsequently remain in that configuration at a temperature of approximately 37 ° C. This may be favorable since the bodies of mammals of particular interest for this invention usually have a temperature of about 35 to 40 ° C. In another embodiment, the method of the present invention may further comprise manually altering the configuration of the body portion and / or at least one scaffold coupling member once the scaffold is placed on the ear or nose. In addition to the methods described in the foregoing, the method of the present invention may further comprise altering the temperature of the scaffold to cause the scaffold to transform from its second preprogrammed configuration to its initial configuration to allow the scaffold to be removed from the ear or of the nose. Preferably, the shape recovery material of the present invention is heated by passing a electric current through the shape recovery material or by adjacent heating elements. This can allow precise control of the shape of the scaffold implant during the insertion process / reshaping process. The method of the present invention is minimally invasive compared to standard otoplastic surgery. In this way, the present invention provides a method for reshaping an ear or a nose, which carries a reduced risk of complications compared to the more extensive dissection required with standard techniques. Thus, when using the method of the present invention, there should be fewer problems with scarring, bleeding, epithelial necrosis and acute folds in the cartilage. It will be understood that the scaffolding of the present invention can be applied promptly. It can take only 10-15 minutes to correct both ears, compared with conventional otoplasty, which takes up to 45 minutes for each ear. Since the scaffolding is hidden under the skin and is embedded in the cartilage. It does not suffer from problems encountered with poor compliance by the patient using non-surgical techniques such as Earbuddies ™ or Auri®Clips.

An advantage of using the scaffolding of the present invention is that the contoured shape of the reshaped nose or ear is highly predictable and reproducible, as compared to standard techniques. For example, the curvature of the antihelical folds is highly predictable and reproducible, compared to standard techniques. In this way, there is a lower risk of asymmetry problems compared to conventional otoplastic surgery. It will be understood that the application of the present invention will result in the immediate correction of the ear or nose deformity, unlike some methods described in the prior art, for example Earbuddies ™ or Auriclip, which must be used for prolonged periods of time for achieve the desired correction by the patient. Each aspect, as defined in the foregoing, may be combined with any other aspect or aspects unless clearly indicated otherwise. In particular, any characteristic indicated as preferred or favorable may be combined with any other characteristic or characteristics indicated as preferred or favorable. The present invention will now be further described, by way of example, with reference to the accompanying drawings, in which: Figures la and Ib show illustrations Schematic of an ear; Figures 2a and 2b show photographs of a prominent ear, due to a deformed antihelical fold, before and after treatment; Figures 3a and 3b show photographs of a prominent ear due to a deep auricular fossa; Figures 4a to 4c show photographs of a young child's ear before, during and after treatment with Earbuddies®; Figures 5a and 5b show photographs of a Auriclip® in use and an illustration of an Auriclip®; Figures 6a to 6c show an illustration of a prominent ear without and with an Auri®strip (Figures 6a and 6b respectively), and the photograph of an Auri®strip (Figure 6c); Figures 7a to 7c show schematic illustrations of an embodiment of the present invention that is being placed on an ear; Figures 8a and 8b show schematic illustrations of an ear scaffold of the present invention; Figures 9a to 9e show schematic illustrations of an ear scaffold of the present invention being inserted into an ear using an applicator; Figures 10a and 10b show schematic illustrations of an ear before and after the insertion of a scaffold of the present invention; Figures 11 to 11c show illustrations of an applicator, which can be used to insert the present invention into the patient; Figures 12a to 12e show the use of the present invention to correct the atrial fossa Profoundly Figures 13a to 13d show schematic illustrations of a nose without a scaffold (Figure 13a), with a scaffold (Figures 13b and 13c); and the scaffolding (Figure 13d); Figure 14 shows a preferred embodiment of an applicator for the scaffold of the present invention; Figure 15 shows an enlarged illustration of a slider, which can be part of the applicator for a scaffold; Figure 16 shows the slider of Figure 15 in place in an applicator, such as that shown in Figure 14; Figure 17 shows an applicator with a locating device; and Figures 18a and 18b show cross sections of the portion (18) of the applicator of the present invention. The Figure shows a schematic illustration of the front view of a human ear, showing the antihelical folds (1) and the atrial fossa (2). In a normal ear, the cartilage (3) of the ear usually protrudes approximately 15 to 17mm from the skin (4). This distance is illustrated in Figure Ib, which shows a cross-sectional view of an ear, taken along the line marked X in Figure la. The photograph of Figure 2a shows a prominent ear due to the absence of an anti-helical, or one poorly formed, fold. This can be corrected by creating an antihelical fold as part of the otoplasty (as shown by the dotted line in Figure 2b). Figure 3a shows a photograph of a prominent ear due to the presence of a deep auricular fossa. Normally, a piece of cartilage should be removed from the ear to reduce the prominence of the ear (as shown in the highlighted section of Figure 3b). Figures 4a to 4c show photographs of a young child's ear before, during and after treatment with Earbuddies. Figure 4a shows a child's ear, which is prominent at birth. Figure 4b shows an "Earbuddy" ® in place in the child's ear. Figure 4c shows the child's ear after treatment. Figure 5a shows a photograph of an Auriclip® in use. Figure 5b shows a photograph of an Auriclip® in greater detail. The Auriclip® has a member on which the auricular cartilage is folded. Auriclip® folds the auricular cartilage when pushing the cartilage from behind. 'Figure 6a shows an illustration of an ear before treatment. Figure 6b shows an illustration of an ear with an Auristrip® in place behind the ear, creating an anti-helical fold. Figure 6c shows Auristrips® cut to size to fit behind an ear. Figure 7a shows an illustration of a prominent ear due to the absence of an anti-helical fold. Figure 7b shows three small incisions that have been made on the back of the skin of the ear. A small subcutaneous tunnel is made in each incision to allow the ear scaffold to be inserted. Figure 7c illustrates the scaffolds that are being inserted and attached to an ear. A schematic illustration of a scaffold embodiment of the present invention is shown in Figure 8a. The scaffolding body (6) may comprise nitinol (or a similar material). The body may comprise a biologically erodible material. Coupling members (5) can be attached to the body of the scaffold. The coupling members may be spikes or tips that will enter the cartilage. The scaffold can be bent in its shape or it can be preprogrammed to a specific degree or curvature (Figure 8b). Figures 9a to 9e illustrate a method self-explanatory to insert the scaffold into the cartilage of an ear. The scaffolding can be mounted on the tip of the applicator (Figure 9a). The scaffold can then be deployed in the cartilage (3). Figure 10a shows an illustration of a cross section of an ear before the insertion of the scaffold. Figure 10b shows the scaffold in place in the ear. The scaffold can be designed so that it can be bent to reshape the antihelical fold for a desired amount, or the auricular clip can be preprogrammed to bend with some degree of curvature, which can be selected before insertion. Figures 11 to 11c illustrate an applicator, which can be used to insert the scaffold of the present invention into an ear or nose. In this mode, the applicator (8) has a group of batteries in its handle, which can be started to heat the scaffolding by means of the switch (7). An actuator may be used to operate the anvil, which drives the auricular clip toward the cartilage. Figure 11b shows an enlarged illustration of the anvil (10). The auricular clip is held towards the end of the applicator (9). In a favorable manner, the auricular clip can be held in a straight line during application to the cartilage. The applicator then slips off, allowing the auricular staple to return to its curved shape when cooling Figure 11c shows the heating elements (11) at the tip of the applicator (8). Figures 12a to 12d illustrate cross sections of an atrial staple (13) that is being inserted into an ear to correct prominence due to a deep atrial fossa. Figure 12e shows a side view of an ear showing the scaffold in place (15) and the incision made in the atrial fossa to place the scaffold (14). Figures 13a to 13d show a scaffold (Figure 13d) of the present invention that is being inserted into a human nose. The skin covering the nose is released (Figure 13a). The scaffold is then inserted into the nasal cartilage (Figure 13b). The scaffold can be secured in place by pushing the coupling members towards the cartilage. The scaffolding can then be converted. in the default form (Figure 13c). In Figure 13c, the scaffold is secured to the alar cartilages by guiding the tines (coupling members) toward the cartilage. Once secured, the nasal cartilages preferably conform to the shape of the scaffolding that reshapes the nose. Figure 14 shows a preferred embodiment of an applicator for the scaffold of the present invention. The applicator may comprise a handle (19), a portion (18) on which the scaffold (not shown) is held before its insertion by a retaining means (17) and a protruding section (16) which helps to place the scaffolding in the applicator in the insertion to the nose or ear. The scaffold is placed in the portion (18) of the applicator prior to insertion. The portion (18) preferably holds the scaffold in the first configuration. The applicator is then inserted into a skin incision made in the ear or nose. Preferably only the portion (18) is inserted into the incision. To facilitate the insertion of the applicator in the incision, the applicator may taper towards the distal end, preferably along the portion (18) as shown in Figure 14. The retention means (17) may be a groove as It is shown in Figure 14, in which the scaffolding is designed to rest. The retaining means may be a channel for releasably retaining the scaffold. The handle (19) can be designed so that a finger can be inserted into it. Preferably, the handle is designed for the insertion of the middle finger. The index finger can then be used to stabilize the applicator. Preferably, the applicator has a stopping means for stopping the subsequent deployment of the portion (18) in the nose or ear. For example, the arresting means may be a projecting section (16) as shown in Figure 16. Preferably, the applicator retains the scaffolding in a first configuration. After the applicator has been inserted under the skin, the scaffold can be deployed in its position by pushing the scaffold from the applicator portion (18), and removing the applicator from the nose or ear. The scaffold can be deployed from the applicator by means of a slider (20) (Figure 15) which is placed on the applicator as shown in Figure 16. The scaffold is folded in the preprogrammed form as it is deployed from the applicator . The applicator may further comprise a locator means (21) attached to the slider (20). The locator means is designed to assist the operator in locating the position of the scaffold center when it has been inserted under the skin. This will allow the operator to guarantee that the scaffolding is located directly on the middle part of the anti-helical fold. An example of a locating means is shown in Figure 17. Figure 18a shows the cross section of the portion 18 of the scaffolding applicator. The scaffold (25) is retained in the applicator prior to insertion into a slot (22) or channel in the portion (18) of the applicator. In this example, the scaffold has a substantially smooth surface, so as to facilitate the insertion of the scaffolding from the applicator. Figure 18b shows a possible alternative in the cross section of the portion (18) of the applicator. In this embodiment, the scaffold is designed to have a rough surface (23) on at least part of its body. In order to facilitate the application of such scaffolding (26), the portion (18) may have a slot (24) or additional channel to make room for the rough surface (23).

Modality 1 In a first example of the present invention, a scaffold is used to reshape the anti-helical folds of the ear for the purpose of correcting a prominent ear (see Figures la and Ib). In this example, to change the shape of the antihelical fold, a thin strip of nitinol metal alloy (or material with similar properties) is inserted into the subcutaneous space of the skin on the back of the ear, through a small incision or series of incisions (Figures 7a to 7c). The scaffolding of the present invention can also be effective when placed in the subcutaneous space on the anterior aspect of the ear. However, it may be more favorable for placement in the posterior position, since this will reduce the likelihood that the coupling member (and any incision to insert it) may become visible over time.

In this example, the scaffold is formed with several thin "spikes", "spikes" or "spikes" along its length (or just at each end) on one side of the band (Figures 8a and 8b). The purpose of these spikes is to allow the scaffold to securely attach to the cartilage of the ear. To fix the scaffold to the cartilage, a specially designed applicator can be used to hold the scaffold in the correct position relative to the anti-helical folds of the ear (Figures la, Ib and Figures 9a to 9e). Once it is in the correct position (Figure 9a), the applicator is deployed to drive the tines towards the cartilage (Figure 9b). This method may be sufficient to hold the scaffold securely (Figure 9c). Alternatively, it may be necessary to cause the prongs to be bent at their tips (Figure 9d) to hold the scaffold more closely to the cartilage. Once the scaffold is secured to the cartilage, it is bent into the shape desired by the user (causing the anti-helical fold to form) or allowed to bend in a preprogrammed manner (Figure 10b). The latter method allows different degrees of curvature to be preprogrammed in the invention before insertion. The specific degree of curvature of the anti-helical crease, required to correct the prominence, can Measure yourself before the scaffolding design. The scaffold can then be designed to specific measurements. The results of this correction method can be highly predictable and reproducible compared to conventional techniques. A possible applicator, used to insert the invention, is shown in (Figures 11a to 11c). The applicator can be electrically driven. This allows the preprogrammed form in the nitinol metal alloy to be activated to order. The preprogrammed shapes can include, for example, a shape where the tines are either straight or curved. The ability to control the shape of the tines can facilitate the removal of the invention from the ear. This may be necessary to allow the position of the invention to be adjusted infinitely to produce the desired effect, and could eliminate any concerns about the learning curve required to produce a particular result. It is anticipated that a maximum of three and a minimum of one of the scaffolds may be required to produce the desired curvature of the anti-helical fold (Figures 7a to 7c). Once inserted, the inventions can be left in place permanently, but can be removed at a later date if problems were to develop.

Modality 2 a second embodiment of the present invention a scaffold is used to correct the deep atrial fossa (see Figures 3a, 3b and Figures 12a to 12e). An incision is made in the atrial fossa to facilitate insertion of the staple (Figure 12b and 12e). A separate incision is made behind the ear to allow the soft tissues to be replaced (Figure 12b). The ear is forced to retreat to the side of the head for the desired amount (Figure 12b). A staple is inserted through the anterior incision, which holds the ear in the desired position (Figure 12c and 12e). It will then be done that the coupling members, for example the tines or pins, are bent, holding the clip in the correct position (Figure 12d), as with the invention to reshape the anti-helical fold.

Modality 3 In the third embodiment of the present invention, a scaffold is used to correct a deformed nose (see Figures 13a to d). The skin covering is released from the nose to allow the deformation of the deformed nasal cartilage. The nose scaffold used to correct the deformity, in this example, comprises two bent body portions. Each portion comprises a substantially straight part and a curved part. The curved part comprises coupling members, which can be used to attach to the cartilage of the nose. The scaffold is inserted into the cartilage of the nasal cavity. The skin cover is then placed on the new cartilage scaffold. The scaffold is then secured to the alar cartilage by guiding the coupling members towards the cartilage. The coupling members are then heated (or can be cooled in other embodiments of the present invention) to cause the coupling members to bend toward the alar cartilage. In other embodiments of the present invention, the coupling members need to bend with the transition to a second preprogrammed configuration. Once the scaffolding is in place. The nasal cartilage can conform to the shape of the new scaffolding, giving a new shape to the nose.

Claims (20)

1. CLAIMS 1. A scaffold to reshape an ear or a nose, the scaffold is configured to be i) attached to the cartilaginous portion of an ear or ii) attached to the cartilaginous portion of the nose, where the scaffold, at least in part, it is formed from a shape recovery material and / or a plastic material having a first configuration and a second preprogrammed configuration. A scaffold as claimed in claim 1, wherein the scaffold comprises a shape recovery material, which can be transformed from a first configuration to a second preprogrammed configuration at a predetermined temperature or over a predetermined temperature range. 3. A scaffolding as claimed in the claim 1 or claim 2, wherein the first configuration is in a forced state and the second configuration is in an unforced state. 4. A scaffold as claimed in claim 1 or claim 2, wherein the first configuration is in an unforced state and the second configuration is in a forced state. 5. A scaffold as claimed in any of the preceding claims, wherein the first configuration is preprogrammed to conform to the form of an ear or nose 6. A scaffold as claimed in any of the preceding claims, wherein the second configuration is preprogrammed to conform to the shape of an ear or nose. A scaffold as claimed in any of the preceding claims, wherein the first or second configuration is substantially curved and the other configuration is substantially straight. A scaffold as claimed in any of the preceding claims, wherein the scaffold is a scaffold for reshaping an ear or a nose and comprises a body portion and at least one coupling member for coupling to the cartilaginous portion of a scaffold. ear or nose, wherein the scaffold, at least in part, is formed from a shape recovery material and is capable of being transformed from a first configuration to a second preprogrammed configuration. 9. A scaffolding as claimed in the claim 8, wherein the body portion, at least in part, is formed from the shape recovery material and is capable of being transformed from a first configuration to a second preprogrammed configuration. 10. A scaffolding as claimed in the claim 8 or 9, wherein at least one coupling member, at least in part, is formed from the shape recovery material and is capable of being transformed from a first configuration to a second preprogrammed configuration. A scaffold as claimed in any of claims 8 to 10, which comprises a plurality of engaging members in the form of tips extending from the body portion. 12. A scaffold as claimed in any of the preceding claims, which is suitable for reshaping the anti-helical folds of the ear. 13. A scaffold as claimed in any of the preceding claims, which is suitable for reshaping the atrial fossa of the ear. 14. A scaffold as claimed in any of the preceding claims, wherein the shape recovery material is an alloy of nickel and titanium. A method for reshaping an ear or nose comprising providing scaffolding as claimed in any of the preceding claims, introducing at least part of the scaffolding into an ear or nose and altering the scaffold to cause the scaffold to be Transform from your first configuration to your second preprogrammed configuration. 16. A method for reshaping an ear or a nose as claimed in claim 15, wherein the scaffold comprises at least one coupling member, and at least one scaffold coupling member is inserted into a cartilaginous portion of a scaffold. ear or a nose 17. A method as claimed in claim 15 or 16, where the temperature of the scaffolding is altered to cause the scaffolding to transform from its first configuration to its second preprogrammed configuration. 18. A method as claimed in claim 17, wherein at least one scaffold coupling member is introduced into the cartilaginous portion of an ear or nose when the scaffold is at an elevated temperature, and wherein the scaffold is transforms from its first configuration to its second preprogrammed configuration as the scaffold cools below a predetermined temperature. 19. A method as claimed in any of claims 15 to 18, which further comprises manually altering the configuration of the body portion and / or at least one scaffolding coupling member once The scaffolding is placed on the ear. 20. A method as claimed in any of claims 15 to 19, which further comprises altering the temperature of the scaffold to cause the scaffold to transform from its second preprogrammed configuration to its initial configuration to allow the scaffold to be removed from the scaffold. ear.