ES2394433A1 - Internal nasal dilator and implant method. (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

The internal nasal dilator is a nasal prosthesis (1) to improve breathing, of the type that are inserted inside the nose (5), characterized by being constituted by an expandable tubular prosthesis formed by nitinol or steel, so that it can be implanted inside the nostrils. When implanted inside the nasal fossa, it allows through its expanding force, the widening of the narrowest areas of the nasal canal, such as internal valves, thus allowing a better air circulation. (Machine-translation by Google Translate, not legally binding)

Description

Internal nasal dilator

Object of the invention

The present specification refers to a nasal (dilator) prosthesis to improve the breathing of the type of those used in the nostrils to expand, inside these, the anatomical narrowings that prevent adequate air circulation. This prosthesis introduces substantial improvements over those known so far and whose characteristics are:

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It allows it to be implanted hidden inside the nostril, solving the aesthetic problem.

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It allows its adjustment to the different anatomy of the nostrils.

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Its fixed implant is a definitive solution to the dynamic or structural obstructive problem.

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It allows its implant in a single nostril.

Technical sector

This invention has its application within the industry dedicated to the manufacture of apparatus, devices and auxiliary elements for medicine and surgery.

State of the art

It is well known the difficulty that many people have to be able to breathe through the nose, difficulty that in a high percentage is due to the collapse of the internal nasal valve, which is located inside the nostrils or other alterations in the canal that carries the air to the nasopharynx. Breathing through the nose has multiple advantages over oral breathing, such as filtering, humidification and heating of the air that will then reach our lungs.

All this air processing does not occur with the same efficiency if breathing is oral. This can lead to people with this problem being more likely to suffer from certain respiratory and oral pathologies.

In addition, difficulty in nasal breathing is a significant problem among athletes who have to resort to external prostheses to keep internal valves open.

The various existing nasal dilators are known, all of which extend the narrowings inside the nostrils. They are fundamentally of two types: external and internal.

Among the known external prostheses are the popular adhesive strips (see documents with Sun No. , which raise the nasal fins to improve the passage of air to inspire.

This adhesive strip has the disadvantage of being single-use, making the solution more expensive, in addition to the aesthetic problem they pose.

Internal nasal prostheses have also been proposed, among which we find two variants, the visible and the non-visible ones.

The first ones require a visible support in the lower part of the nose and must be used in unison in the two nostrils, with the consequent unsightly problem and limiting the social environment of use. Rigid devices are an important discomfort (see documents with Nº Sol. U8903070, U8803129, U0191829).

The latter are of two types, essentially one of cylindrical aspect and difficult malleability, so several sizes are required as required by the nostril (see document with No. Sun. E96906134). And the other type of internal nasal prosthesis proposed (see document with No. Sol. U200402368), which consists of a winding, flexible and deformable spring type to allow adjustment to the nasal cavity, also being a removable prosthesis so it does not imply final solution. In addition, the thick gauge of the spring can cause significant lesions in the nasal mucosa and nasal septum during the extraction and introduction processes. To solve the problems posed by the anterior prosthetic nasal dilators, the holder of the present development Miguel Ahumada Vidal designed a new internal, expandable and adjustable nasal prosthesis for implantation in the nostril.

Description of the invention

Internal nasal dilator: biocompatible mechanical element, with an elongated body (for example generically cylindrical) that includes a plurality of turns (or loops) of sinusoidal design, and interconnections between the turns so that the dilator is stretched longitudinally (at along its axis). The cylindrical body is constructed with a moldable material and adaptable to the particular anatomy of each nostril, such as nitinol

or steel The dilator separates the nasal walls from the inside, preventing the collapse of the canal or dilating its narrowness, maintaining its shape once expanded. The dilator can in turn be implanted by a catheter-balloon that can be made up of different materials and sizes.

Since the anatomy of the nostrils of people has different morphologies and measures, said prosthesis will be executed in different dimensions, and it is possible for each user to adjust the prosthesis to the appropriate pressure to allow adequate air passage.

The BASIC characteristics of a nasal dilator consist of:

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Avoid closing the nostril, either by alterations in the mucosa, in the internal veil or in the anatomy.

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Reduce difficulty in nasal breathing with the health consequences that it entails.

The SPECIFIC characteristics of the new nasal dilator consist of:

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The solution to the aesthetic problem posed by previous nasal prostheses, since being internal in its entirety, can be used in any social circumstance.

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Allows use in a single nostril.

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It does not require maintenance since its implementation is final.

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It is very adaptable to the particular anatomy of the nostril, given its expandable character.

Once the nature of the present invention has been described, we only have to add that as a whole and its component parts, it is possible to introduce changes in shape and materials, as well as its coating, as long as said alterations do not substantially vary the nature of the invention claimed.

Preferred Embodiment of the Invention

The internal nasal dilator in question is composed of an expandable mesh designed with biocompatible material, to avoid adverse reactions, with an elongated body that includes a plurality of turns (or loops) of sinusoidal design, and interconnections between the turns in a way that prevents The mesh stretches longitudinally. The cylindrical body is constructed with a moldable material and adaptable to the particular anatomy of each nostril, such as nitinol or steel. The dilator separates the nasal walls from the inside, preventing the collapse of the canal or dilating its narrowness, maintaining its shape once expanded. The dilator can be mounted on a catheter-balloon that allows its expansion into the nasal cavity, by inflating said balloon with air or other substances, which in turn can be made up of different materials.

For its preferential use, the appropriate measures of the nostril should be carried out, so that we can choose the size of the prosthesis to be implanted.

Subsequently, the dilator will be inserted into the nostril, which can be mounted on a balloon catheter, and implanted in the narrow area of the nasal passage.

After implantation, the release system will be removed leaving the dilator impacted in the nasal mucosa with the desired size, leaving the duct open for proper air circulation.

Description of the drawings

To better understand the object of the present invention, the drawings are attached for preferential practical realization.

Figure 1 shows the nasal dilator (1) folded over the catheter (2) -balloon implantation system (3). In figure 2 the balloon (3) begins to expand with the consequent expansion of the nasal dilator (1). The balloon (3) can swell variably according to the needs of the patient as can be seen in Figure 3, where the nasal dilator (1) has expanded to the maximum.

Finally, the catheter-balloon is removed leaving only the nasal dilator (1) inside the nasal cavity, as shown in Figure 4.

Figure 5 shows a cross section at the height of the internal valves (4), partially collapsed, of the nostrils of the nose (5). Figure 6 shows an anatomical section at the same height as the previous one with two nasal dilators (1) implanted in both nostrils, resolving the collapse of the

10 internal valves (4) previously observed.

Figure 7 shows the arrangement of the nasal dilator (1) inside the nostril in a lateral view of the nose (5). Finally, Figure 8 shows a section of the nasal dilator.

Claims (4)

1. Internal nasal dilator to keep the nostril open of the type not visible and for independent use per fossa nasal, characterized by being configured by a single piece of mesh, with an elongated body of cylindrical shape, flexible and expandable, formed by interconnected sinusoidal designs. 2. Internal nasal dilator according to claim 1, characterized in that the mesh is constructed of a deformable material that allows its adaptation to the nasal cavity, preferably nitinol or steel. 3. Internal nasal dilator according to claim 1 and 2, whose mesh is characterized by periodic sinuous designs with a unidirectional axis perpendicular to the main axis of the internal nasal dilator leaving enclosed spaces of the same size between said designs. 4. Internal nasal dilator according to claim 1, 2 and 3, whose sinuous designs are characterized by being interconnected at their points of maximum approximation. SPANISH OFFICE OF THE PATENTS AND BRAND Application no .: 201000073 SPAIN Date of submission of the application: 07.25.2011 Priority Date: REPORT ON THE STATE OF THE TECHNIQUE 51 Int. Cl.: A61M15 / 08 (2006.01) RELEVANT DOCUMENTS

Category

Documents cited Claims Affected

X

WO 03092765 A2 (DUBRUL WILLIAM R et al.) 13.11.2003, 1-4

figures 2,8,9; page 2, lines 30-35; page 3, lines 1-10; page 5, line 35; page 6,

lines 1-8; page 8, lines 20-35; page 9, lines 1-2.

TO

WO 2006034008 A2 (EXPLORAMED NC1 INC et al.) 30.03.2006, 1-4

Figure 4B, 4C, 4D, 4E; pages 23.30; claims 33,46,77-78.

TO

US 2008053458 A1 (DE SILVA BERTRAND et al.) 06.03.2008, 1-4

figures 1-3; page 2, column 1; claims 1,3-4.

Category of the documents cited X: of particular relevance Y: of particular relevance combined with other / s of the same category A: reflects the state of the art O: refers to unwritten disclosure P: published between the priority date and the date of priority submission of the application E: previous document, but published after the date of submission of the application

This report has been prepared • for all claims • for claims no:

Date of realization of the report 22.11.2011

Examiner C. Marín Calvo Page 1/4

REPORT OF THE STATE OF THE TECHNIQUE Application number: 201000073 Minimum documentation searched (classification system followed by classification symbols) A61M Electronic databases consulted during the search (name of the database and, if possible, terms of search used) INVENES, EPODOC, WPI State of the Art Report Page 2/4  WRITTEN OPINION Application number: 201000073 Date of Written Opinion: 22.11.2011 Statement

Novelty (Art. 6.1 LP 11/1986)

Claims Claims 1-4 IF NOT

Inventive activity (Art. 8.1 LP11 / 1986)

Claims Claims 1-4 IF NOT

The application is considered to comply with the industrial application requirement. This requirement was evaluated during the formal and technical examination phase of the application (Article 31.2 Law 11/1986).  Opinion Base.- This opinion has been made on the basis of the patent application as published. State of the Art Report Page 3/4  WRITTEN OPINION Application number: 201000073  1. Documents considered.- The documents belonging to the state of the art taken into consideration for the realization of this opinion are listed below.

Document

Publication or Identification Number publication date

D01

WO 03092765 A2 (DUBRUL WILLIAM R et al.) 13.11.2003

 2. Statement motivated according to articles 29.6 and 29.7 of the Regulations for the execution of Law 11/1986, of March 20, on Patents on novelty and inventive activity; quotes and explanations in support of this statement The technical object of the invention is an internal nasal dilator to improve breathing. The inventor intends to implant it within each nostril to expand, inside these, the anatomical narrowings that prevent adequate air circulation. To this end, it proposes a device configured by a single piece of mesh, with an elongated body of cylindrical, flexible and expandable shape, formed by interconnected sinusoidal designs. Document D01 is considered the closest state of the art and discloses a medical device (30), which is illustrated in Figures 8 and 9, which includes a radially expandable tubular element (32) in the form of a mesh and ends ( 10, 12) with an adequate size to pass through the nostrils. The mesh design is periodic sinusoidal with a unidirectional axis perpendicular to the main axis of the dilator interconnected at its points of maximum approximation. In Figure 5, it is observed how the tubular element (6), which can be made of stainless steel or nitinol, is implanted by means of a support element (8) that will be removed once the tubular element is expanded, creating a channel that allows the air passage All the technical characteristics of claims 1-4 are already known from document D01. Therefore, claims 1-4 are novel in view of the state of the art known and do not meet the criteria set forth in Article 6.1 of Law 11/86 of March 20 of Patents. State of the Art Report Page 4/4