DREAM NOSE - UNIVERSAL NOSE IMPLANT - CSG & SEG

Nasal prosthesis – Columellar prosthesis – DREAMNOSE™
Summary
The present disclosure relates to a multifunctional prosthesis for reconstructive and aesthetic surgery with insertion into the nose to relieve breathing created by a deviated septum and simultaneously act as a universal apparatus to achieve results in terms of nasal tip elevation, thinning and curvature. hitherto not found among a huge range of techniques and related products presented to date. The invention is composed of a trapezoid-like structure in the same shape as the base of the human nasal septum, which will serve as a support for the fixation of the columella rod in the shape of a cupid's arrow (arrow with rounded edges).

In short, we are presenting a columella prosthesis composed of a columella rod and support of the columella rod in the anatomical shape of a three-dimensionally (3D) printed human nasal septum base as a final result, nasal septum reconstruction with some types of deformities or by aesthetic modifications aiming at the most innovative to achieve the elevation and curvature of the nose of dreams - using a method to develop the model of the universal and customizable columellar prosthesis with state-of-the-art technology according to computed tomography – CT files of each respective patient, being reliable the most delicate nuances according to the peculiarities of each unique and exclusive anatomy in the diverse ethnicities found in the entire globe. In the technology of 3D printed devices, the columellar prosthesis was 3D printed using fusion and deposition modeling (FDM), being manufactured from a composite material of thermoplastic polyurethane MD Flex - TPU of 98 A of hardness with nanocomposites of copper properly certified with all relevant ISO's for broad spectrum antiviral, antifungal and antibacterial properties, biocompatibility, non-cytotoxic in contact with human skin, FDA and European Union approved from the renowned manufacturer of active and validated materials COPPER 3D.
The three-dimensional prostheses of the disclosure can be manufactured using a rapid prototyping machine. In some cases, the three-dimensional shape of the base of the columella shaft may be fabricated to match a respective three-dimensional shape of the base of a patient's nasal septum for a perfect fit and fixation thereof in accordance with the anatomy shown.

Knowing that the deviated septum is one of the most worrisome basic faults, in particular, when dealing with a deviation in the nasal bone with predominant blockage in the air passages in order to prevent the free flow of air through the nostrils during the breathing process and that Rhinoplasty is one of the most performed plastic surgeries in Brazil, having surpassed even the famous liposuction in recent years, according to recent research, demand had an extremely expressive increase in the beginning of the pandemic until the current dates.

DREAMNOSE ™ had been developed, a device that consists of a fusion of techniques, insights, extensive personal and professional experiences in the respective segment, improved and applied in practice with mastery in an unprecedented way in the world of personalized medicine using three distinct areas:

                                             Aesthetics - Medicine - 3D Printing

Nasal / Columellar Prosthesis Claims (3)
Having described the invention, what is claimed is:
1. Nasal/columellar prosthesis device to relieve respiratory restrictions and aesthetic application in order to obtain the desired nasal tip elevation and curvatures quickly, safely, effectively and permanently, comprising
(a) a base/support in the shape of a human nasal septum base for perfect anatomical fit of the columellar nail,
(b) a cupid's arrow-shaped columella rod (rounded arrows) to comprise a single strong, flexible and customizable structure to suit any and all forms of elevation and curvature (within the boundary references extracted from the CT-CT files of each respective patient).
(c) through fixation of screws in the base/support of the columellar nail, the fixation/anchoring of the apparatus/device in the nasal septum will be carried out, where the columellar rod will be introduced through the base/support of the columellar rod, fixing it to the base of the nasal septum with 1.5mm x 6mm screws and subsequently the necessary fine-adjustment fittings and spaced sutures in said elongated structural means (a transseptal columellar stabilizing suture - TCSS or a medial crura anchor suture or a projection control suture).
(d) to allow for better configuration when said structure is inserted into the nasal/columellar passage and also to allow for adjustments of said sides in relation to each other for a period of time commensurate with the wearer's ability to withstand discomfort and need .
A nasal/columellar prosthesis device as claimed in claim 1 wherein said columella rod includes an additional extension for the purpose of manual manipulation of the frame for perfect adjustment in elevation and curvature, and can be cut for more specific customization or at your discretion. of the surgeon in which the surgery will be performed, in case it becomes necessary
The columellar rod support apparatus as claimed in claim 1 wherein said human nasal septum base-shaped columellar rod support is secured with 1.5mm x 6mm screws thereby holding the columellar rod in position for fittings and fittings. sutures for fine adjustments of tip elevation and curvature.
4. Septum/columellar prosthesis - DREAMNOSE ™, was printed in 3D using fusion and deposition modeling (FDM), being manufactured from a composite material of thermoplastic polyurethane MD Flex – TPU of 98 A hardness with copper nanocomposites duly certified with all relevant ISO's for broad spectrum antiviral, antifungal and antibacterial properties, biocompatibility, non-cytotoxic in contact with human skin, FDA and European Union approved from the renowned manufacturer of active and validated materials of COPPER 3D.
Material validated and certified by NASA for the third consecutive year to be used on current and future interplanetary missions for the safety of their astronauts and space module environments.

Description of applicable techniques:

Purpose
Minimal deformity or instability following columellar nail prosthesis (CSG) placement can be resolved by placing a suture between the columella nail and the caudal septum, such as a medial crural anchor suture or a control suture. projection.
Materials and methods
A transseptal columellar stabilizing suture (TCSS) was developed for the management of tip projection and final location and increased stability after placement of the CSG - DREAMNOSE™.

Results
Tip projection and rotation can be carefully controlled by changing the position of the TCSS and/or using a columellar rod (CSG) of different lengths in order to reduce, maintain or increase projection and curvature according to the limits established in the planning performed. with the data extracted respectively from the DICOM files of the Computed Tomography (CT). In addition, TCSS provided greater stability for the columellar nail. It was not necessary to remove any previous sutures or the graft.
Conclusion
The TCSS usefully controls the final positions and shapes of the tip, columella, and base of the nasal septum providing stability to columella support after CSG. In addition, TCSS is a simple and time-saving procedure.

-