Anatomic external nasal splint

Abstract

The external nasal anatomic splint is a device that shapes the nose by creating weak and strong lines, prominences, depressions, and curves to achieve the desired form. It follows the surgeon's hand just in specific axes and lines, producing a standard and aesthetically pleasing final shape. This splint aims to create beautiful nasal surface anatomy, assisting surgeons in preserving and enhancing nasal shape delicacies immediately post-operation to mitigate undesirable effects of postoperative swelling. Current splints have some imperfections such as asymmetrical placement leading to nasal deviation, lack of inward curvature at the back of the nose where a graceful arch is essential (especially for females), absence of aesthetic lines at the back of the nose, and inability to counteract bone force effects on nasal deformity.

Description

DescriptionTitle of Invention : Anatomic External Nasal SplintTechnical Field

[0001] This invention pertains to the field of plastic surgery instruments and manufacturing.Background Art

[0002] At the end of the nose surgery, the nasal bone is broken and unstable, the vessels of the surgery site still have a small amount of bleeding, the cartilages and soft tissue have been manipulated, and in the next 48 hours they will be swollen and moved from the desired place. A nose splint is used to keep the bone in its place, reduce and stop bleeding, reduce soft tissue swelling and maintain its proper shape.

[0003] The use of external nasal splints dates back to ancient times, with evidence of its use in ancient Egypt and Greece. These early splints were often made of materials such as wood, metal, or leather and were used to support and protect the nose after injury or surgery.

[0004] Rhinoplasty has been performed for more than a century, and this surgery has gained many fans in recent decades.

[0005] In the 19th century, advances in medical technology led to the development of more complex nasal splint materials. German surgeon Johann Dieffenbach used gutta-percha, a natural latex material, for nasal splints in the 1830s. Guttapercha was flexible, moldable and durable, making it an ideal material to support and shape the nose during treatment. In the early 20th century, plastic surgery pioneer Jacques Joseph used celluloid for external nasal splints. Celluloid was a synthetic plastic material that could be molded to conform to the contours of the nose and was more comfortable for patients to wear than previous materialsUntil about three decades ago, some surgeons used orthopedic plaster to fix the nasal bone. This work is not limited to cosmetic surgery and this plaster was also used after reduction after fracture. This work had problems. The surgeon had to spend a lot of time preparing plaster and cutting it and then shaping it on the inose. It took a long time to dry and its appearance was also very unpleasant. As technology continued to advance, new materials such as silicone and thermoplastics were introduced for use in external nasal splints. These materials are more flexible, durable and comfortable. 3D printing technology has made it possible to make customized nasal splints according to the patient's needs, but it has limitations in practice, and although it may help in broken noses, in addition to being very expensive and time-consuming, in cosmetic surgery, the nose Before the operation, it is very different from the ideal nose, and it is not a suitable mold for the ideal design of the future nose, and this method is not practical

[0006] Currently, smooth silicone or thermoplastic sheets that have a trapezoidal shape are the most widely used. This splint is a flat and hard trapezoidal plate that is placed in hot water for a few seconds until it is heated and becomes flexible and paste-like when heated. The characteristic of achieving flexibility is to change from white to colorless appearance. At this time, it is placed on the nose and folded with the pressure of the fingers and takes the shape of the nose to some extent. A layer of paper glue is placed on the nose and then a layer of liquid glue, so that the splint is not in direct contact with the skin and does not cause skin wounds, and the liquid glue makes the splint and the skin more tightly connected. Immediately, ice water is poured on the splint and the splint is hardened again and turns from colorless to white again. The current method has the following problems:

[0007] 1 - The splint may be placed asymmetrically on the nose and cause the nose to tilt to one side

[0008] 2- The splint can create unfavorable angles or surface irregularities depends on the human error and surgeon's finger in different areas.

[0009] 3- Due to folding in vertical axes, the splint does not bend inward at and remains in a straight line, while in this part, a beautiful nose (especially in women) should have an inward curve.

[0010] 4- The dorsal surface of the nose should have a relatively specific angle with the lateral surfaces, which is called the dorsal aesthetic line. It is not possible to create this amount of folding in the existing splint.

[0011] 5- Dorsal esthetic line may be uneven and asymmetrical.

[0012] 6- The aesthetic lines of the nose are better to be closer together in the center; Currently, it is not possible to create such a form.

[0013] 7- The shape of a beautiful nose is different in men and women. The most important difference is the amount of dorsal curve, which is currently not a difference in splints for both men and women.

[0014] 8- According to its consistency and the connection of muscles to it, the nasal bone is pulled outward with more force, and this issue causes deformity after the operation. Currently, the existing splint does not help to solve this problem.

[0015] 9- To quickly cool the splint, cold water should be used, which requires a refrigerator or water cooler

[0016] 10- The splint needs hot water, but if the temperature of the water is too high or the splint remains in the water for a long time or the melting temperature of the splint is low, or its thickness is low, the splint will completely melt and lose its shape, and another splint must be used.

[0017] The purpose of this invention is to solve the stated problems. By creating lines of weakness and strength, ridges, depressions and curves, the shaping of the splint is optimal and follows the surgeon's hand only in specific and limited axes and lines, and in many cases the final shape is predicted in a standard and beautiful way rather than anatomy. To create a beautiful nose surface and to help the surgeon to preserve and to some extent strengthen the subtleties of the shape of the nose that he created during the operation and to prevent the adverse effects of the swelling period after the operation

[0018] In the review of previously registered patents, we come across a few similar cases, but upon closer inspection, we realize the obvious difference of this invention and its uniqueness in many ways.

[0019] Many cases of nasal splint or nasal splint are related to internal nasal splint , which go away by themselves. In the cases where the external nasal splint or external nose splint has been registered and the external nasal splint was meant, the following cases can be mentioned.

[0020] 1_Hand, Timothy F etc all 08 / 524959

[0021] 2_Le, Andrew. 15 / 737569

[0022] 3_Brennan, Louis G. 07 / 528823

[0023] 4-Kaczperki, Jeffrey etc all. 13 / 661231

[0024] 5_Obando, Marcelo 12 / 608701

[0025] 6_Shippert, Ronald. 09 / 041044

[0026] 7-Straith, Richard E. 06 / 2222601

[0027] All the above items have been checked and compared and have many differences with this invention which will be explained. Compared to other inventions, it should be said:

[0028] The invention of Hand, Timothy F. etc. No. 08 / 524959 is a two-layer splint that emphasizes more on the expansion of the airway, so far it has not targeted the goals of the surgeon in shaping a beautiful anatomy, and having a layer of glue has limited its shaping. Although the purpose of adding the adhesive layer was the convenience of the surgeon, it did not make it possible to achieve proper shaping during the operation and proper strength immediately after gluing to the nose, and it is not of much use. This is the problem of the invention of Le, Andrew under thenumber 15 / 737569 and the invention of Louis G and Breman under the number 07 / 528823 and the invention of Shipped, Ronald under the number 09 / 041044 and other cases, it can be seen that instead of increasing their use, it has caused the lack of acceptance by surgeons and leaving them aside, and currently none of them have general use, and only special people can use them in special cases.

[0029] Kaczperski, Jeffrey et all's patent No. 13 / 661231 includes several adjustment screws and many construction details, the design, shape and application of which are significantly different from this patent.

[0030] In the case of Obando, Marcelo's invention number 12 / 608701 , it has a completely different form and application.

[0031] Straith, Richard E's patent number 06 / 2222601 also has a completely different application and form.Technical Problem

[0032] The current nasal splint is a smooth and rigid trapezoidal plate that is heated in hot water for a few seconds, becoming flexible and acquiring a doughy consistency when warmed. At this time, it is placed on the nose and pressed with fingers to preserve shape the nose.

[0033] Current methods encounter several problems, such as potential asymmetric placement of the splint on the nose leading to nasal deviation, inability of the splint to conform inwardly behind the nasal dorsum where a graceful curve (particularly in females) is necessary, and also the existing splint cannot counteract the effects of nasal bone force and maybe displaced.

[0034] The objective of this invention is to make a splint that, with weak and strong lines, prominences, depressions, and curves, shapes it into the desired form, comply surgeon hand just in specific axes and lines , and predictably achieving a standard and aesthetically pleasing, symetric final shape to preserve and enhance beautiful nose anatomy. This aids the surgeon in preserving and reinforcing the nasal desirable shape refinements made during surgery, and prevents undesired effects during the post-operative swelling.Solution to Problem

[0035] In order to solve the above-mentioned problems in this invention, all the predictions in the design and production stage have been made without the above-mentioned disadvantages and shortcomings; Therefore, the following is an explanation for each problem:

[0036] 1 - To prevent asymmetry, the shape is made with exact axial symmetry, and in the area where the most curvature should be created, by creating a row of holes, the exact place of folding is determined.

[0037] 2- To avoid undesirable angles and unevenness related to the fingerprints of the surgeon, the material has limited plasticity and only the predicted shape can be obtained, which is completely symmetrical and desirable.

[0038] 3- To strengthen the beauty lines of the nose in the desired area, it is easily folded and can take a sharp angle, which makes the underlying soft tissue have a sharper angle and the dorsal esthetic lines are more defined.

[0039] 5- The curve of the dorsum of the nose is foreseen in the design of the splint, and the central part of the splint has protrusions on both the M and W surface (W = Women — M = Men).

[0040] 6- The difference between the noses of both genders has been noticed in this splint. One surface is used for women (W surface) and the prominence of the central area is more. In the other surface (M surface), the prominence is little or almost none for men.

[0041] 7- To create a stronger connection to the bottom layer, there are many holes in different areas of the splint with a funnel section so that the glue will stick more after entering them.

[0042] In order to focus fixation force on the bones , a ridge is created on the surface of the splint in the part that is placed on the bones, because the bones are pushed out more by the force of the muscles from the outside or the tissue between them from the inside. This makes it better to deal with more internal pressure.

[0043] 9- Splint is made of a material that does not need ice water to cool down quickly and can be cooled with tap water or other room temperature washing solution.

[0044] 10- The splint is made of a material that does not become a paste in hot water and can only be bent, so there is no possibility of its shape being damaged.

[0045] 11 - The current splints are kneaded by hand after heating to increase the surface area or cut to reduce the residual size, but the material and design of our splint made difficult cutting it with scissors and the surface does not increase with hand pressure. To solve this problems, the splint is designed in three sizes to be used for different noses, and in addition, there is a peripheral section on the side of the splint, which is the cutting line for downsizing the splint.

[0046] This splint is in the shape of a trapezoid and has two surfaces M and W (W = Women — M = Men). When used in women, the W surface(Figure 1 ) is placed on the skin of the nose and the M surface (Figure 2) is visible. In men, surface M is placed on the skin of the nose and surface W is outside.

[0047] The smaller side of the trapezoid is placed on the root of the nose . The invention has a central part (No. 1 ) and two wings on the sides, which are bent by the surgeon's fingers when is used. In the previous types of nasal splint, this bending is with a gentle curve, but in this design, the sharp bending of the splint causes the formation of better dorsal aesthetic lines and thus improves the result of the surgery. An axial groove at the midline of surface M just help surgeon to differentiate two surfaces.

[0048] The central part has a curved projection on each surface (numbers 2 and 3), which is placed on the nose and bends downward symmetrically from the place of two rows of parallel holes (number 4). This protrusion is considered more for women (comparison of size 2 and 3) because in the standard of nose beauty, the curve on the nose of women is more than that of men.

[0049] In terms of surface anatomy, the nose is divided into four parts, the uppermost part is the bony part, then the place where the bone connects to the cartilage, and the bottom is the cartilaginous part of the nose, and the nose ala are located right outside, and this anatomy is considered on the splint.

[0050] On each side, four parts (numbers 7, 8, 9 and 10) are designed, separated by three rows of holes (number 6). The lowest part (number 7) is placed on the ala of the nose. Above it , is a part (number 8) that is placed on the cartilages of the nose and has a small projection. The third part (number 9) is placed at the junction of cartilage and bone, and the highest part (number 10) is placed on the bones of the nose, and this part also has a projection. On the lower side of the splint, in the central part, a recess (number 12) is provided for the placement of the tip of the nose. One to three v-shaped indentations in this area (number 11 ) are only indicative of the size of the splint, because this invention is supposed to be made in three sizes, small, medium, and large, which are slightly different from each other, and these indentations help the surgeon to find the right size fasterAdvantageous Effects of Invention

[0051] The advantages of this splint compared to the existing splint include:

[0052] 1 . Better creation of the curve of the dorsum of the nose by predicting the projection on the splint

[0053] 2. Dorsal aesthetic lines is more defined by defining and sharpening the curve on the splint

[0054] 3. Making the beauty line more regular and beautiful by creating a standard and accurate bending line on the splint .

[0055] 4. Predicting more pressure on the bony part of the nose to prevent the common complication of bone widening.

[0056] 5. Predicting the shape of a beautiful nose with the design of several transverse weak lines on the wings of the splint

[0057] 6. Prevent splint melting by changing the material

[0058] 7. No need to use cold water by using material with higher melting point

[0059] 8. Made in different sizes to compensate for the impossibility of changing the size

[0060] Explanation of at least one implementation method for applying the inventionBrief Description of DrawingsFig.1 Invention surface designed for female people (surface W)

[0061] No. 1 ) Central Section

[0062] No. 2) The protrusion of the central part of surface W

[0063] No. 3) The protrusion on the opposite side of No. 2 (surface M)

[0064] No. 4) Holes on both sides of the central part.

[0065] No. 5) Marginal holes

[0066] No. 6) Three rows of transvers holes

[0067] No. 7) Semicircle peer to nose ala.

[0068] No. 8) Protrusion peer to cartilaginous part of the nose

[0069] No. 9) Even surface peer to junction of cartilage and nasal bone

[0070] No. 10) Prominence peer to nasal bone

[0071] No. 11 ) A depression in the center of the large border of the splint peer to the tip of the nose

[0072] No. 12) A number of v shaped indentations indicating the size of the splint.Fig. 2 - Inventive page designed for male people (level B)Description of Embodiments

[0073] This splint is almost an isosceles trapezoid, each leg is 50 mm, its height is 40 mm, the larger side is 60 mm, the smaller side is 40 mm, and its thickness is 2mm. Its corners are curved. The splint has a central part and two lateral wings. The large border is placed at the nostrils side and the smalle border is placed on the root of the nose when used, and the central part is placed on the dorsum of the nose and the two side wings are placed on the walls of the nose, which is described in more detail below:

[0074] 1 - The central part, which is almost rectangular from the top view, with dimensions of 40 x 5 mm.

[0075] 2- In the profile view of this central rectangle, a curvature in each side is visible , one with a maximum thickness of 2.5 millimeters is evident on one nostril side.

[0076] 3- Curvature with a maximum thickness of 1 mm on the side opposite to the previous one , which is visible in the profile view. This maximum thickness is in the lower third

[0077] 4- Two parallel rows of holes about 3x4 mm dimensions between central part and lateral wings.

[0078] 5- A row of rectangular holes in the peripheral part with dimensions of 3.5 x 2 which can seprate a strip of splint.

[0079] 6- Three rows of transverse holes with dimensions of 2 x 3 mm on each wing, which divide them into four parts.

[0080] 7- The most anterior part on the wing, which is a semicircle

[0081] 8- The second part on each wing, which has a 2 millimeter overall thickness with two ridges on each side and surface, that is, 4 ridges in total.

[0082] 9- The third part on the wing, which is between two transverse parallel lines and has a flat surface

[0083] 10- The fourth and the most superior part, which has a one millimeter thickness ridge on each side and surface, that is, a total of four ridges.

[0084] 11 - One to three small triangular V shaped indentation at the center of large border of the splint

[0085] 12- A depression in center of the large border of the splint.Industrial Applicability

[0086] In rhinoplasty surgery in order to maintain the shape of the nose and keep its soft tissue and bones in an ideal condition in 4 to 7 days after the operation.

Claims

ClaimsClaim: What is claimed:

1. It is an anatomical nasal splint where each section of the splint surface is thickened, thinned, or even perforated in a way that the splint reshapes to have a closer resemblance to the ideal nasal shape. It includes a central part with two curve projection of each surfaces (M and W), two rows of large holes around the central portion, one row of marginal holes, three rows of transvers holes which divid each wing to 4 part as below: a semicircle peer to nasal ala, prominence peer to cartilaginous part of the nose, flat surface peer to the junction of nasal cartilage and bone, and a prominence peer to nasal bone. The material of the splint prevents unwanted deformation

2. According to Claim 1 , the central section completely symmetrically curves the implant.

3. According to Claim 1 , elevation of the central section's surface W gives a natural appearance to women's nasal profile.

4. According to Claim 1 , elevation of the central section's surface M gives a natural appearance to men's nasal profile.

5. According to Claim 1 , bilateral large holes around the central part symmetrically and sharply bend the implant for better final shape of the nose.

6. According to Claim 1 , marginal holes conform the edge of the implant with soft nasal tissue.

7. According to Claim 1 , three rows of transverse holes make the implant more pliable at this areas.

8. According to Claim 1 , semicircle peer to nasal ala improves its appearance by bending outward.

9. According to Claim 1 , prominence peer to cartilaginous part creates appropriate depression on this part.

10. According to Claim 1 , flat surface at junction of nasal cartilage and bone makes cartilage at the same levele with bone.

11. According to Claim 1 , prominence peer to nasal bone keeps them closer together by pressing against bones.

12. According to Claim 1 , The material of the splint does not easily become a paste and prevents unwanted deformation i

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