Multi-diameter pediatric tracheal cuff.
Abstract
The present description is made with reference to an endotracheal tube for a child, the tube has a balloon mounted near the distal end of the tube. The tube has a ventilation lumen and an inflation line that is used to inflate the balloon. The balloon is mounted to the tube at a lower mounting point and at a higher mounting point. The top mounting point is above the level of the vocal cords. The balloon has a lower and upper diameter when inflated, and the upper diameter is 1.1 to 1.5 times larger than the outer diameter of the tube.

Term
6.1 yearsleft in the term
Expires 24 October 2032.
- Priority
- Filed
- Granted
- Today
- Expires
20 claims: 4 independent, 16 dependent
- 1REIVINDICACIONES 1. Un tubo endotraqueal para un niño que tiene una tráquea con un diámetro y cuerdas vocales a un nivel en la tráquea, que comprende:un tubo que tiene un diámetro exterior sobre el cual está montado un globo cerca de un extremo distal de dicho tubo, una línea de inflado que se utiliza para inflar dicho globo, dicho globo montado a dicho tubo en un punto de montaje inferior y en un punto de montaje superior, dicho punto de montaje superior adaptado para ser colocado encima del nivel de dichas cuerdas vocales, el globo es infiable en una región de las cuerdas vocales y en una región debajo de las cuerdas vocales de modo que el globo tiene un diámetro inferior de inflado en la región debajo de las cuerdas vocales y un diámetro superior de inflado en la región de las cuerdas vocales, en donde el diámetro superior de inflado es más pequeño que el diámetro inferior de inflado, el globo se ahusa desde el diámetro superior de inflado hasta el diámetro inferior de inflado, en donde el diámetro superior de inflado es constante sobre una longitud de diámetro superior, la longitud de diámetro superior definido desde el punto de montaje superior hasta el nivel de las cuerdas vocales, en donde el diámetro superior de inflado es mayor que el diámetro exterior del tubo y el diámetro inferior de inflado es al menos igual al diámetro traqueal inferior por debajo de las cuerdas vocales, y en donde el globo es un manguito de alto volumen/baja presión IMPI INSTITUTO MEXICANO DE LA PROPIEDAD INDUSTRIAL para sellar la tráquea.
- 2El tubo endotraqueal de conformidad con la reivindicación 1, en donde dicho diámetro superior de inflado del globo es desde 1.2 a 1.4 veces el diámetro exterior del tubo.
- 3El tubo endotraqueal de conformidad con la reivindicación 1, en donde dicho diámetro inferior de inflado del globo es al menos igual al diámetro traqueal debajo de las cuerdas vocales.
- 4El tubo endotraqueal de conformidad con la reivindicación 2, en donde dicho diámetro inferior de inflado del globo es desde 1.1 a 1.8 veces el diámetro traqueal debajo de las cuerdas vocales.
- 5El tubo endotraqueal de conformidad con la reivindicación 2, en donde dicho diámetro inferior de inflado del globo es desde 1.3 a 1.6 veces el diámetro traqueal debajo de las cuerdas vocales.
- 6El tubo endotraqueal de conformidad con la reivindicación 1, en donde dicho globo está hecho de un polímero seleccionado del grupo que consiste en polímeros termoplásticos de poliuretano, elastómeros de poliolefina termoplásticos, copolímeros de bloque de poliolefina termoplásticos, Elastómeros di-bloque SBS, Elastómeros tri-bloque SEBS , Cloruro de Polivinilo (PVC), Polietileno Tereftalato (PET) y combinaciones y mezclas de los mismos.
- 7El tubo endotraqueal de conformidad con la reivindicación 1, en donde dicho globo tiene un grosor de entre 1 y 25 micrones.
- 8El tubo endotraqueal de conformidad con la reivindicación 1, en donde dicho globo tiene un grosor de entre 5 y 15 micrones.
- 9El tubo endotraqueal de conformidad con la reivindicación 1, en donde dicho globo tiene una presión de inflado de entre 5 y 30 mmHsO.
- 10El tubo endotraqueal de conformidad con la reivindicación 1, en donde dicho globo tiene una presión de inflado de entre 15 y 25 mmHaO.
- 11El tubo endotraqueal de conformidad con la reivindicación 1, en donde diámetro inferior de inflado del globo se mantiene sobre una longitud de diámetro inferior, en donde la longitud de diámetro inferior es al menos 5 mm y la longitud de diámetro superior es al menos 5 mm.
- 12El tubo endotraqueal de conformidad con la reivindicación 1, en donde el globo cambia desde el diámetro superior de inflado al diámetro inferior de inflado dentro de menos de 5 mm.
- 13El tubo endotraqueal de conformidad con la reivindicación 1, en donde el globo cambia desde el diámetro superior de inflado al diámetro inferior de inflado dentro de menos de 3 mm.
- 14Un tubo endotraqueal para un niño que tiene una tráquea con un diámetro y cuerdas vocales a un nivel en la tráquea, que comprende:un tubo que tiene un diámetro exterior sobre el cual está montado un globo cerca de un extremo distal de dicho tubo, una línea de inflado que se utiliza para inflar dicho globo, IMPI , INSTITUTO MEXICANO .. DE LA PROPIEDAD ¿¿i INDUSTRIAL WÍF·:·. · dicho globo montado a dicho tubo en un punto de montaje inferior y en un punto de montaje superior, dicho punto de montaje superior adaptado para ser colocado encima del nivel de dichas cuerdas vocales, el globo es inflable en una región de las cuerdas vocales y en una región debajo de las cuerdas vocales de modo que el globo tiene un diámetro inferior de inflado en la región debajo de las cuerdas vocales y un diámetro superior de inflado en la región de las cuerdas vocales, en donde el globo es un manguito de alto volumen/baja presión para sellar la tráquea que tiene una presión de inflado de no más de 30 mmHaO, en donde el diámetro superior de inflado es más pequeño que el diámetro inferior de inflado, dicho diámetro superior de inflado es constante sobre una longitud de diámetro superior, la longitud de diámetro superior definido desde el punto de montaje superior hasta el nivel de las cuerdas vocales, en donde el diámetro superior de inflado es mayor que el diámetro exterior del tubo y el diámetro inferior de inflado es al menos igual al diámetro traqueal inferior a las cuerdas vocales, y en donde el diámetro inferior de inflado se mantiene para una longitud de diámetro inferior, la longitud de diámetro inferior está dentro de un rango de longitudes que tienen un valor mínimo de 5 mm.
- 15El tubo endotraqueal de conformidad con la reivindicación 14, en donde la longitud del diámetro inferior es aproximadamente 10 mm y la longitud del diámetro superior es ϋβτπντοMEXICANO oeu propiedad 20 ^t.· industrial ***** ' ' 1 n ·' aproximadamente 10 mm.
- 16El tubo endotraqueal de conformidad con la reivindicación 14, en donde el globo cambia desde el diámetro superior de inflado al diámetro inferior de inflado dentro de menos de 5 mm.
- 17El tubo endotraqueal de conformidad con la reivindicación 14, en donde el globo cambia desde el diámetro superior de inflado al diámetro inferior de inflado dentro de menos de 3 mm.
- 18Un tubo endotraqueal para un niño que tiene una tráquea con un diámetro y cuerdas vocales a un nivel en la tráquea, que comprende:un tubo que tiene un diámetro exterior sobre el cual está montado un globo cerca de un extremo distal de dicho tubo, una línea de inflado que se utiliza para inflar dicho globo, dicho globo montado a dicho tubo en un punto de montaje inferior y en un punto de montaje superior, dicho punto de montaje superior adaptado para ser colocado encima del nivel de dichas cuerdas vocales, el globo es inflabie en una región de las cuerdas vocales y en una región debajo de las cuerdas vocales de modo que el globo tiene un diámetro inferior de inflado en la región debajo de las cuerdas vocales y un diámetro superior de inflado en la región de las cuerdas vocales, en donde el globo es un manguito de alto volumen/baja presión para sellar la tráquea que tiene una presión de inflado de no más de 30 mmH20, en donde el diámetro superior de inflado es más pequeño que el diámetro inferior de inflado, dicho diámetro superior de inflado es constante IMPI iNsmvTp mexicano M LA MONEDAD WOUSTRIAL sobre una longitud de diámetro superior, la longitud de diámetro superior definido desde el punto de montaje superior hasta el nivel de las cuerdas vocales, en donde el diámetro superior de inflado es mayor que el diámetro exterior del tubo y el diámetro inferior de inflado es al menos igual al diámetro traqueal inferior a las cuerdas vocales, y en donde el diámetro inferior de inflado se mantiene para una longitud de diámetro inferior tal que la longitud de diámetro inferior y la longitud de diámetro superior son al menos de 5 mm.
- 19El tubo endotraqueal de conformidad con la reivindicación 18, en donde la longitud del diámetro inferior es aproximadamente 10 mm y la longitud del diámetro superior es aproximadamente 10 mm.
- 20El tubo endotraqueal de conformidad con la reivindicación 18, en donde el globo cambia desde el diámetro superior de inflado al diámetro inferior de inflado dentro de menos de 5 mm. IMPI •NStijuro mexicano »e la raoriHUD iwwnuAt
Independent claims20
120 paragraphs in 30 sections, as filed
(54) Title: PEDIATRIC TRACHEAL SLEEVE OF VARIOUS DIAMETERS.
(54) Title: MULTI-DIAMETER PEDIATRIC TRACHEAL CUFF.
(57) Summary
The present description is made with reference to an endotracheal tube for a child, the tube has a balloon mounted near the distal end of the tube. The tube has a ventilation lumen and an inflation line that is used to inflate the balloon. The balloon is mounted to the tube at a lower mounting point and at a higher mounting point. The top mounting point is above the level of the vocal cords. The balloon has a lower and upper diameter when inflated, and the upper diameter is 1.1 to 1.5 times larger than the outer diameter of the tube.
(57) Abstract
The present disclosure describes an endotracheal tube for a child, the tube having a balloon mounted near the distal end of the tube. The tube has a ventilation lumen and an inflation Une used to Inflate the balloon. The balloon is mounted to the tube at a lower mounting point and an upper mounting point. The upper mounting point is above the level of the vocal cords. The balloon has a lower and upper diameter when inflated, and the upper diameter is from 1.1 to 1.5 times larger than the outer diameter of the tube.
IMPI
<img file="MX351990B_D0001.tif" />
<img file="MX351990B_D0002.tif" />
Mbw<sup>to</sup>* v '
PATENT TITLE No. 351990
Holders): AVENT, INC.
Address: 5405 Windward Parkway, Alpharetta, Georgia, 30004, USA
D nomination: PEDIATRIC TRACHEAL CUFF OF VARIOUS DIAMETERS.
Classification:
CIP:
CPC:
A61M16 / 04
A61M .5
Inventors):
JAMES F. ^ C ^ MACHER
Number:
MX / a / 2014/006293
Country:
US n International:
'x | e 2012'
Number:
13/344,267
Validity: V <iñ ^ years.
Date of V ^^ nien ^^ Date of Eaj ^ HIcion ^. · .X · '
The patent of referendrmf qtgrga with fundametljg enjos art
S. *
In accordance with article 3 of the Law Jeta PropiedfKMn «aM ^ J from the date of filing of the application and will be subject to ...... · 'v Whoever subscribes to this title shall do so» ^ fun <6Üienta§n <sup>10</sup> di ^ uestt ^ (Official Gazette of the Federation wWH27 / ^ 99lT? 9lprmAa on '25/01/2006, 06/05 / 2009,06 / 01/2010, 396/2 ^ 0, «8 / 06β» 1ίΟζ / ® / 2012 Regulations of the Mexican Institute cfrW®ejNAad MdiíStrial'fÉ tpforrogables, counted to date.
a »« sicuie so26 / 12 / 'articles 1, 3<sup>or</sup>, 4<sup>or</sup>, 5<sup>or</sup> fraction V subsection a), JftJra <as¡oiTOsJ · 12/27/1999, amended on 10/10/2002, 07/29 / jDQ4 ^ lfflW2B »4 Deputy Generals, Coordinator, Departmental Directors and other subordinates of the INSTITUTE MexiAno 04 / 08/2004 and 09/13/2007).
/ 30 aerTWwMroOrgarw
I ^ Pja | Siad | Khiatfustriah, 2 of the Industrial Property Law 1 ^ 05/1999, 01/26/2004, 06/16/2005, jpdpo a), 4th and 12th sections I and III of ^ 07 / 2004, 07/28/2004 and 09/07/2007);
_____________ 'no of Industrial Property (DOF ΆΛΜο that delegates powers to the Directors ítiti *> M.
g | £ s, Divisional Deputy Directors, Coordinators 12/5/1999, amended on 02/04/2000, 07/29/2004,
This document is signed with an advanced electronic signature (FIEL), based on articles 7 BIS 2 of the Industrial Property Law; 3 of its Regulations, and 1 section III, 2 section V, 26 BIS and 26 TER of the Agreement establishing the guidelines for the use of the Payment and Electronic Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.
THE DIVISIONAL DIRECTOR OF PATENTS
NAHANNY CANAL REYES
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Arenal No. 55 (> Floor 1 Pueblo Santa María Tepepan, Xochimilco, 16020.
Gntkid from Mexico.
Í55) ñ. <Oi0700 vavw gob mx / impi ι · ιι · ιιι
ΜΧ / 2017/90109
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IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX351990B_D0004.tif" />
PEDIATRIC TRACHEAL SLEEVE OF VARIOUS DIAMETERS
FIELD OF THE INVENTION
The present disclosure relates to a balloon cuff for an endotracheal tube for use with pediatric patients.
BACKGROUND OF THE INVENTION
It is well known in the medical community that children are not just little adults. Medications, for example, may have no or the opposite effect on a child and at the same time be very effective for an adult. Also, pediatric anatomy is quite different from that of adults. The distance from the vocal cords to the mouth is different than in adults and the tissues of the throat, fragile and sensitive as they are in adults, are even more in children.
Conventional tracheal tubes typically have a tube that serves as an artificial passageway for air exchange between a patient and an air source, usually either atmospheric air or a mechanical respirator or ventilator. The distal end of the tube is usually equipped with a small, inflexible balloon, also called a cuff, that can be filled with a fluid (eg. g., air) The balloon adheres to the inner lining of the trachea in its generally transverse dimension in order to prevent the air inflated by the respirator into a - -<sup>J</sup> -OR.......
<img file="MX351990B_D0005.tif" />
patient to escape to the environment through the larynx and pharynx. This allows air to reach the lower airways and eventually the pulmonary alveoli. The balloon also helps support the tube inside the windpipe.
Pediatric tracheal tubes without sealed cuff balloons are available, however they are unfavorable for ventilation in many cases, however, surgery is especially problematic, since it requires constant maintenance of anesthesia (stable ventilatory minute volume) and levels of constant blood gases, as is potentially the case, for example, with intraoperative neurosurgical or cardiac ventilation. During intensive care ventilation, spontaneous changes in the child's position can be associated with considerable fluctuations in air leakage and make stable ventilation impossible despite close monitoring. A cuffed tube is also sometimes preferred in interventions in the head area or where there is a lot of bleeding or in intraoperative antiseptic irrigation of the oral and pharyngeal cavities, due to the inadequate sealing efficiency of an uncuffed tube. Blood, debris, and throat secretions will otherwise find their way almost unhindered into the distal airways and can significantly complicate the ventilatory course and course during and immediately after extubation.
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY ________
Adapting an adult endotracheal tube for use in children has proven surprisingly difficult. Fred Gobel has given a solution to this problem in US patent 7,849,857 in which specific dimensions are given. These dimensions place the top point for mounting the balloon to the tube below the level of the vocal cords to avoid damage. This solution works quite well. It would give greater flexibility to the medical professional and for fabrication, however, if there were a balloon that could be mounted so that the upper point of attachment of the balloon to the tube was within the area of the vocal cords at the time of use, however, it would prevent damage to the vocal cords.
What is needed is a balloon that can be mounted to a tracheal tube to a point such that it will be within the area occupied by the vocal cords when the tube is in use.
<img file="MX351990B_D0006.tif" />
SUMMARY OF THE INVENTION
An endotracheal tube is provided for a child, the tube has a balloon mounted near the distal end of the tube. The tube has a ventilation lumen and an inflation line that is used to inflate the balloon. The balloon is mounted to the tube at a lower mounting point and at a higher mounting point. The top mounting point is above the level of the vocal cords.
The balloon has a lower and higher diameter when inflated, the
<img file="MX351990B_D0007.tif" />
IMPI
MEXICAN INSTITUTE OF PROPERTY INDUSTRIAL The lower diameter is below the vocal cords and the upper diameter falls within the level of the vocal cords. The top diameter is 1.1 to 1.5 times larger than the outside diameter of the tube. The top diameter can also be 1.2 to 1.4 times the outer diameter of the tube.
The lower diameter is at least equal to the tracheal diameter below the vocal cords. The lower diameter can also be 1.1 to 1.8 times the tracheal diameter below the vocal cords or more particularly 1.3 to 1.6 times the tracheal diameter below the vocal cords.
The balloon may be made of a polymer selected from the group consisting of thermoplastic polyurethane polymers, thermoplastic polyolefin elastomers, thermoplastic polyolefin block copolymers, SBS di-block elastomers, SEBS tri-block elastomers, Polyvinyl Chloride (PVC), Polyethylene Terephthalate (PET) and combinations and mixtures thereof.
The balloon can be between 1 and 25 microns thick most desirably between 5 and 15 microns. The balloon has an inflation pressure of between 5 and 30 mmHzO, more desirably between 15 and 25 mmH<sub>2</sub>0.
Other objects, advantages and applications of the present description will be clarified by the following detailed description of a preferred embodiment of the description and the accompanying drawings in which the reference numbers refer to similar or equivalent structures.
<img file="MX351990B_D0008.tif" />
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
----——
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a drawing of a conventional PEDIATRIC endotracheal tube having a cuffed balloon that can damage a child's vocal cords. The balloon expands in the region that encompasses the vocal cords (dashed line).
Figure 2 is a drawing of a PEDIATRIC endotracheal tube in accordance with the teachings of US Patent 7,849,857. The top mounting point of the balloon is below the region of the vocal cords.
Figure 3 is a drawing of a PEDIATRIC endotracheal tube in accordance with the teachings herein. The top mounting point of the balloon is within the region of the vocal cords, however the balloon does not expand in this area.
Figure 4 is a drawing of another embodiment of a PEDIATRIC endotracheal tube having a balloon with two different diameters, one larger towards the distal end and one smaller towards the proximal end of the balloon.
DETAILED DESCRIPTION OF THE INVENTION
Reference will now be made to the drawings in which the various elements of the present description will be given numerical designations and in which, the description will be discussed in order to enable one skilled in the art to make and use the description. It is to be understood that the following
<img file="MX351990B_D0009.tif" />
IMPI
Dernyro Mexicano DELAMOHEDAD INDUSTRIAL description is only an example of the principles of the present description and should not be construed as limiting the pending claims. Those skilled in the art will appreciate that the aspects discussed in terms of the different modalities can be interchanged and modified without departing from the scope and spirit of the description.
Figure 1 is a state of the art drawing of an endotracheal tube 10 for a child. Tube 12 has a balloon 14 mounted near its distal end. It also has an inflation line 16 that is used to inflate the balloon 14. The balloon 14 is mounted to the tube 12 at a lower (distal) mounting point 13 and an upper (proximal) mounting point 15. The dashed line shows the approximate level of the vocal cords. As can be seen from the drawing, the state of the art balloon 14 expands within the area of the vocal cords. Balloon expansion in this area can damage the vocal cords and should therefore be avoided if possible.
Figure 2 is a drawing of an endotracheal tube 20 for a child, made in accordance with US Patent 7,849,857. Tube 22 has a ventilation lumen (not shown) that runs the entire length of tube 22 in order to supply breathable air to the patient. Tube 22 has a balloon 24 mounted near the distal end. It also has an inflation line 26 in fluid communication with and used to inflate the balloon 24 in the conventional manner. Balloon 24 is mounted to tube 22 at a mounting point
<img file="MX351990B_D0010.tif" />
Lower (distal) 23 and to a (proximal) mounting point 25. The dashed line shows the approximate level of the vocal cords. As can be seen from the drawing, the balloon 24 according to US patent 7,849,857 has a top mounting point 25 below the level of the vocal cords and thus expands in the area below the level of the vocal cords to avoid damage them.
The balloon in accordance with the teachings herein is designed to have two diameters when inflated; a higher diameter and a lower diameter. This dual diameter balloon has an upper diameter (in the vocal cord region) that is smaller than the lower diameter (below the vocal cords) .The larger diameter in each of the two regions (not an average ) is the key dimension to be used in this document. In some modalities, when inflated the upper diameter may be only slightly larger than the tube itself in the area of the vocal cords, which will vary depending on the size of the child. A desirable range for the top diameter is 1.1 to 1.5 times larger than the outside diameter of the tube to which the balloon is mounted. Most desirably, the top diameter can be 1.2 to 1.4 times the outside diameter of the tube to which the balloon is mounted. The lower diameter should have an inflation size that is at least equal to the tracheal diameter, which, of course, will vary depending on the size of the child. More particularly, the lower diameter may be the same or larger than the
<img file="MX351990B_D0011.tif" />
IMPI
D0HTUTD MKXICANO DI LA OROPIIDAD INDUSTRIAL
<img file="MX351990B_D0012.tif" />
tracheal diameter; p. eg, 1 to 2 times the tracheal diameter in the area below the vocal cords. More desirably the lower diameter can be 1.1 to 1.8 times the tracheal diameter in the area below the vocal cords and even more desirably approximately 1.3 to 1.6 times the tracheal diameter in the area below the vocal cords. The balloon is tightly fitted, preferably by adhesive bonding or welding, to the distal portion of the tube, as illustrated.
Figure 3 is a drawing of an embodiment of an endotracheal tube 30 for a child, made in accordance with the teachings herein. Tube 32 has a balloon 34 mounted near its distal end. It also has an inflation line 36 which is used to inflate the balloon 34 in the conventional manner. Balloon 34 is mounted to tube 32 at a lower (distal) mounting point 33 and an upper (proximal) mounting point 35. The dashed line shows the approximate level of the vocal cords. As can be seen from the drawing, the balloon 34 according to these teachings expands in the area below the level of the vocal cords, avoiding damage to them, while having an upper mounting point 35 above the level of the vocal cords. The balloon then has two diameters, one in the region of the vocal cords (the top diameter 38) and one below the vocal cords (the bottom diameter 37). The transition between the two diameters of this balloon is relatively gradual, as in a taper.
<img file="MX351990B_D0013.tif" />
IMPI · MEXICAN INSTITUTE. - DB THE PROPERTY. INDUSTRIAL
Figure 4 shows another embodiment of the PEDIATRIC tube having a balloon 34 with two different diameters that relatively abruptly change (within less than 5mm, desirably less than 3mm) from one diameter to the other. The superior (proximal) diameter 48 is only slightly larger than the tube but the diameter below the vocal cords, eg. ex. the lower diameter 47, is larger than the tracheal diameter as mentioned above. The length of each of the various diameters is not critical to the operation of the balloon, except that it is important that the lower diameter be continuous for a sufficient distance to provide a seal against the tracheal wall and distribute the force of the expanded balloon. Therefore the length of the bottom diameter parallel to the tube should be at least 5mm, ideally 10mm except for the smallest sizes where such a distance is impractical.
The table below shows an exemplary range for various parameters in accordance with the modalities of the teachings herein. With reference to Figure 4, the tube can have, for example, using the first line of the table; a tube with an inner diameter of 3 mm and an outer diameter of 4.3 mm. Children at this age (0-1 years) usually have an internal transverse tracheal diameter of about 7mm (see table). The distance from the distal tip to the distal balloon mounting point can be 5 to 7 mm. The balloon has a diameter below the vocal cords of almost 10mm and maintains this diameter for a length
<img file="MX351990B_D0014.tif" />
IMPI
MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY from 7 to 9mm. The balloon has a top diameter (inside the vocal cords) of 1.1 times the diameter of the outer tube to about 1.5 times the diameter of the outer tube and maintains this diameter for a length of about 8mm. The distance from the distal tip of the tube to the upper mounting point can be between 18 and 24mm. The data in this table is intended to be exemplary only and is not intended to limit the modalities or scope of the invention.
<td>LE size of Tube (m)</td><td>Size year of the Tub 0 (mm)</td><td>Target age group (years)</td><td>Internal transverse tracheal diameter 1. (mm)</td><td>Tip of Tube to Distal Mounting Point of Sleeve (mm)</td><td>Lower Sleeve Diameter (mm)</td><td>Length of the Lower Sleeve Diameter («11»)</td><td>Top Sleeve Diameter Range (mm)</td><td>Diameter Length Upper Sleeve {mm}</td><td>Tip or Tube to Proximal Mounting Point of Sleeve (mm)</td>
<td> 3.0</td><td> 4.3</td><td> 0-1</td><td>6.87 í 0.78</td><td> 5-7</td><td> 10</td><td> 7-6</td><td rowspan="9">Min »1.2 * (OD of Tube) Max = 1.5 * (SD of</td><td> 8</td><td> 18-24</td>
<td> 3.5</td><td> 5.0</td><td> 1-2</td><td> 7.20 ± 0.84</td><td>6-é</td><td> 12</td><td> 5-12</td><td> 16</td><td> 26-30</td>
<td> 4.6</td><td> 5.6</td><td> 2-4</td><td> 8.53± 1.07</td><td> 7- 10</td><td> 12</td><td> 5-13</td><td>1st</td><td> 26-32</td>
<td> 4.6</td><td> 6.3</td><td> 4-6</td><td> 3671 1.60</td><td>S-i1</td><td> 14</td><td> 12-15</td><td> 14</td><td> 34-40</td>
<td> 5.6</td><td> 6.7</td><td> 6-8</td><td> 11.00± 1.52</td><td> 10-12</td><td> 14</td><td> 12-15</td><td> 14</td><td> 35-41</td>
<td> 5.5</td><td> 7.3</td><td> 8-16</td><td> 12.02 ± 1.85</td><td> 11-13</td><td> 16</td><td>14- 1e</td><td> 16</td><td> 41 -47</td>
<td> 6.0</td><td> 16</td><td> 10-12</td><td>1423 ± 2.QQ</td><td>li-16</td><td> 18</td><td> 14 -16</td><td> 16</td><td> 42-40</td>
<td> 6.6</td><td> 8.7</td><td> 12 -14</td><td> 14.14 + 2.36</td><td> 13-16</td><td> 20</td><td> 15-23</td><td> 26</td><td> 52-59</td>
<td> 7.6</td><td> 5.3</td><td> 14-16</td><td> 15.83 + 2.16</td><td> 14-17</td><td> 20</td><td> 19-23</td><td> 26</td><td> 63-66</td>
In the desired embodiments, the balloon is preferably formed of thin films that can be designed to be high volume / low pressure cuffs. In these modalities, the diameter of the balloon in the free expansion phase, not intubated, considerably exceeds the diameter of the trachea to be intubated as previously indicated. An exemplary safety tolerance is generally
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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX351990B_D0015.tif" />
of about 50%. When using a high volume / low pressure cuff to seal the trachea, due to the expansion of the cuff cover that occurs in the trachea to occlude it, there is virtually no expansion of the cuff cover under the pressures that potentially damage the tissue which are common with low volume / high pressure cuffed balloons. This results in an intentional kinking of the balloon cover and allows filling pressures that are compatible with perfusion. This provides the user with the assurance that the barometric pressure measured on the cuffed balloon largely matches the pressure transmitted transmurally to the tissue. In adult intubation, severe injuries to the trachea or larynx have been successfully reduced to a very low level, even with long-term intubation, through the use of such high-volume cuffed balloons with a plastic sheath. cuff that is bent in place. Other mentions of high-volume balloons can be found in, for example, US patents 6,802,317 and 6,526,977, which teach oversized balloons with such a low wall thickness that the balloon walls are folded against the wall of the balloon. the trachea and folds are so small that secretions cannot pass through them and travel to the lungs.
US Patent 6,802,317 describes a sleeve for sealing the trachea of a patient as tightly as possible; It comprises a cuffed balloon that blocks the trachea below the glottis of a
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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
<img file="MX351990B_D0016.tif" />
patient, an air tube, the cuffed balloon that connects to the air tube and is sized to be larger than a tracheal diameter when in a full inflation phase and made of a soft and flexible foil material that forms at least one fold draped onto the cuffed balloon when inflated into the patient's trachea where the foil has a wall thickness below or equal to 0.01mm and the draped pleat (s) has a loop that is located at the end end of the draped pleats, that loop has a small diameter that inhibits a free flow of secretions through the loop of the draped pleat (s).
US Patent 6,526,977 teaches a dilator to seal a patient's trachea as tightly as possible; It comprises a cuffed balloon, which blocks the trachea below the glottis of a patient, an air tube, the cuffed balloon that connects to the air tube and is sized to be larger than a tracheal diameter when in a full inflation phase and made of a soft, flexible foil material that forms at least one fold draped in the cuffed balloon when fully inflated into the patient's trachea where the draped fold (s) that formed are capillary in size, This stops the free flow of secretions along the globe by virtue of the capillary forces formed within the fold to prevent aspiration of secretions and subsequent infections related to aspiration of secretions.
<img file="MX351990B_D0017.tif" />
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INSTINCT MtJUCANO
DtlAHKlHCDAD INDUSTRIAL
Suitable polymers for tracheal tube production include Polyvinyl Chloride, Polyurethane and Polyolefins such as Polyethylene and Polypropylene. Nylons and Polyethylene Terephthalate (PET) materials can also be used although their cost can be prohibitive. Suitable Polymer blends can also be used. It is also possible to use known extrusion techniques to extrude parts of the tracheostomy tube from a single polymer and other parts of the tracheal catheter from another polymer. For example, the lumen walls of the vent can be made of a first polymer such as Polyvinyl Chloride and the flexible wall can be made of a second polymer such as polyurethane. A particularly suitable polymer is a Polyvinyl Chloride commercially available from Colorite Polymers Inc. as 8566G-015.
In the practice of the technology described, the balloon component can be formed from polyurethane thermoplastic polymers, thermoplastic Polyolefin elastomers, thermoplastic Polyolefin block copolymers, SBS di-block elastomers, SEBS triblock elastomers, Polyvinyl Chloride (PVC ), Polyethylene Terephthalate (PET) and combinations and mixtures thereof. Polyurethane can most desirably be used because it has been found to cause less irritation to tissues compared to other materials. Useful Polyurethanes include those from the Dow Chemical Company (Dow Plastics) available
<img file="MX351990B_D0018.tif" />
IMPI
INSTITUTE MEXICANO DE LA FKOFIEDAD INDUSTRIAL under the registered trademark Pellethane®. Pellethane® Thermoplastic Polyurethane elastomer is available in a number of grades and hardnesses and the particular one selected for a specific use will depend on the properties desired in the final product. The hardness of a polymer, for example, is an attribute that can be varied to meet the requirements of various applications. An exemplary polyurethane is designated Pellethane® 2363-90A and has a hardness value, determined by a durometer, of 90A (ASTM D-2240). This Polyurethane has a softening temperature of 110 ° C (ASTM D-790) and a melt index of 30 g / 10 min. at 224'C, 2160 g (ASTM D-1238). The balloon is desirably very thin, with a thickness on the order of 25 microns or less, e.g. ex. 20 microns, 15 microns, 10 microns, or even as low as 5 microns in thickness, 1 micron minimum. Ideally the balloon should also be a low pressure cuff operating at an inflation pressure of between 5 and 30 mmH20, more desirably between about 15 and 25mmH2O.
As used herein in the claims, the term "comprise" is inclusive or open and does not exclude additional non-recited elements, composition components, or method steps.
While various patents have been incorporated herein by reference, to the extent that there is any inconsistency between the incorporated material and that of the written description, the latter shall control. Furthermore, although the description has been made in detail with
<img file="MX351990B_D0019.tif" />
MWnilTB MEXICANO ΟΧΙΑ INDUSTRIAL PROPERTY Regarding specific modalities thereof, it will be apparent to those skilled in the art that various alterations, modifications and other changes can be made to the description without departing from the spirit and scope of the present description. The claims are therefore intended to cover all such modifications, alterations, and other changes included in the appended claims.
<img file="MX351990B_D0020.tif" />
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MEXICAN INSTITUTE OF INDUSTRIAL PROPERTY
Contents30
26 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11 Sheet 12 Sheet 13 Sheet 14 Sheet 15 Sheet 16 Sheet 17 Sheet 18 Sheet 19 Sheet 20 Sheet 21 Sheet 22 Sheet 23 Sheet 24 Sheet 25 Sheet 26
15 members in 8 offices
Priority claims7
| Document | Office | Kind | Date |
|---|---|---|---|
| 13314267 | United States of America | – | |
| 201113314267 | United States of America | A | |
| 2012055859 | International Bureau of the World Intellectual Property Organization (WIPO) | W | |
| 13314267 | – | – | – |
| PCTIB2012055859 | – | – | – |
| US201113314267 | – | – | – |
| WO2012IB55859 | – | – | – |
Members15
| Document | Office | Kind | |
|---|---|---|---|
| CA2857288A1 | Canada | A1 | |
| US2013146062A1 | United States of America | A1 | |
| WO2013084086A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU2012349768A1 | Australia | A1 | |
| MX2014006293A | Mexico | A | |
| CN104010686A | China | A | |
| EP2788061A1 | European Patent Office (EPO) | A1 | |
| JP2015500080A | Japan | A | |
| AU2012349768B2 | Australia | B2 | |
| MX351990BThis record | Mexico | B | |
| US9821130B2 | United States of America | B2 | |
| EP2788061B1 | European Patent Office (EPO) | B1 | |
| JP6276699B2 | Japan | B2 | |
| CN104010686B | China | B | |
| CA2857288C | Canada | C |
2 legal events, as the office reported them to INPADOC
Over the term
Point at a mark for the eventEvents
| Event | Code | |
|---|---|---|
| Grant or registrationFG | FG | |
| Transfer or rightsGB | GB |
Numbers
- Publication
- 351990
- Publication, DOCDB
- 351990
- Publication, EPODOC
- MX351990
- Application
- 2014006293
- Application, DOCDB
- 2014006293
- Application, EPODOC
- MX20140006293
Titles2
- Spanish
- MANGUITO TRAQUEAL PEDIATRICO DE VARIOS DIAMETROS.
- English
- PEDIATRIC TRACHEAL SLEEVE OF VARIOUS DIAMETERS.
Classification
- CPC, 3
- A61M16/04
- A61M16/0443
- A61M16/0445
- IPC, 1
- A61M16 04