Abstract: A metal dilator for tracheostomy is made of brass and consists of a cylindrical metal stem (S1, S2, S3)) with pointed tip (P) at the front, integral with cylindrical metal neck (N1, N2, N3) at the back having a shoulder (D) in between the two with holes at front and back. The metal dilator is autoclaved or disinfected under higher temperature and pressure and the contour of the pointed tip (P) is maintained despite repeated deployment of the dilator.
FIELD OF INVENTION
The present invention relates to a metal dilator for tracheostomy. More
particularly, the invention relates to an autoclaved metal dilator which can be
repeatedly autoclaved and used as a surgical instrument.
BACKGROUND OF THE INVENTION
Tracheostomy is a surgical procedure by which an opening is made in the
anterior wall of trachea (wind pipe). Through this opening a curved tube is
passed which is called tracheostomy tube to separate the part of the wind pipe
above the opening from the lower portion of wind pipe. This is done for various
indication in clinical practice such as 1) where a tube must be put in the wind
pipe for sucking out secretion repeatedly when patient can not cough out 2)
when there is obstruction in the upper part of wind pipe 3) patient on long term
artificial breathing through a mechanical device (ventilator).
There are various methods of doing tracheostomy. Percut tracheostomy is
popular alternative to other techniques as it can be done fast with minimum
blood loss and less trauma to wind pipe and the tissues. There are again various
methods for doing percutaneous tracheostomy. Grigg's method is very frequently
used technique where these dilators are used. Originally a plastidilator is used.
The disadvantages of using the plastic dilators are as follows:
(1) plastic dilators come with the disposable kit which is very costly
(2) plastic dilator is for single use
(3) plastic dilators cannot be autoclaved that is cannot be disinfected under high
temperature and pressure
(4) the contour of the pointed tip of a plastic dilator cannot be maintained, if
used repeatedly.
Hence there exists a need to provide a dilator which can eliminate the
disadvantages of prior art.
OBJECTS OF THE INVENTION
Therefore it is an object of the invention to propose a metal dilator for
tracheostomy which is cost effective.
Another object of the invention is to propose a metal dilator for tracheostomy
which can be repeatedly deployed to perform the process.
Yet another object of the invention is to propose a metal dilator for tracheostomy
which can be autoclaved easily for repeated utilization.
A further object of the invention is to propose a metal dilator for tracheostomy
which is durable and maintains the contour of its pointed tip for performing
numerous tracheostomies.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
Fig.l - shows reusable tracheostomy metal dilators.
Fig.2 - shows photographs of metal dilator in use.
Fig.3 - shows a photograph of a plastic dilator in use.
DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT OF THE
INVENTION
The technique of percutaneous tracheostomy is known as Griggs' guide wire
forceps technique where according to the original kit supplied, a plastic dilator
was so far being used. This plastic dilator has many disadvantages and is for
single use. According to the present invention a metal dilator is used in place of
the plastic dilator. Metal dilators can be reused as the shape remains maintained
despite repeated use and it can be disinfected easily. This metal dilator is made
of brass. Metal instruments made of stainless steel are used regularly in surgical
procedure. As shown in Fig.1, the brass dilators (A, B, C) of the present invention
are used in the percutaneous tracheostomy that come in contact with the body
for less than 30sceonds and cause no harm to human body. Metal dilators
(A,B,C) used in place of plastic dilator have the following advantages:
1) It is cost effective
2) It can be repeatedly utilized to perform the process
3) It can be autoclaved easily i.e. can be disinfected under higher
temperature and pressure rendering it suitable for repeated use without
causing any harm to human body.
4) It is durable and maintains the contour of its pointed tip in spite of
repeated use.
An experimental trial was conducted with the metal dilator in accordance with
the invention and it was possible to perform 270 tracheostomies by a single
brass dilator. Hence, it has been found to be cost effective.
In addition to this brass dilator, an alternative to the 14 G cannula and guide
wire provided in the original kit was deployed in the process of tracheostomy to
make the method more cost effective. In place of 14G cannula of original kit,
16G I.V. cannula was used, and in place of thick J wire of the original kit, thinner
J wire which goes through 16G cannula was used.
Cost analysis
Cost of original kit (including tracheostomy = Rs. 5200/-
guide wire, 14G cannula, plastic dilators,
syringe but excluding 'Howard Kelly' forceps)
Approximate cost of modified technique with
approximate market price for one tracheostomy,
Tracheostomy tube = Rs. 600/-
Guide wire = Rs. 50/-
IV cath 16 G = Rs. 40/-
Syringe = Rs. 10/-
Metal dilator = Rs. 10/- (per tracheostomy)
3 dilators are used simultaneously in one tracheostomy. Cost of 3 metal dilators
is Rs. 3000/-. At least 300 tracheostomy can be done with these three dilators.
Hence, 1 tracheostomy cost will be Rs. 3000/300 = Rs. 10/-
Three metal dilators, big (A), medium (B) and small (C) made of brass are used
in three different lengths. Three metal dilators (A, B, C) are used simultaneously
in one tracheostomy. Each dilator consists of a cylindrical metal stem (S1, S2, S3)
with pointed tip (P) at front and a cylindrical metal neck (N1, N2, N3) at the back
machined integrally with a shoulder (D) in between the two. The range of length
of stems (l5) of (A) is 50-54 mm, (l3) of (B) is 33-35.5 mm and (l1) of (C) is 22.5-
23 mm. The range of length of necks (l6) of (A) is 16.5-17.5 mm, (l4) of (B) is
16.5-17.5 mm and (l2) of (C) is 18-18.5 mm. The range of neck diameters (N1) of
(A) is 4-5.5 mm, (N2) of (B) is 4-4.5 mm and (N3) of (C) is 4-4.5 mm. All the
dilators have holes at back and front. The dilator (A) has at the back, hole (h6) of
2.8-3.2 mm, (B) has hole (h5) of 1.5-1.8 mm and (C) has hole (h4) of 1.5-1.8
mm. Each of the dilators (A, B, C) has hole at the front (h3, h2, h1) in the range
of 0.9-1.1 mm.
In one of the step of the method of tracheostomy, the cannula 16 G.I.V is
introduced in the tracheal lumen and guide wire is passed. Cannula is then
removed leaving the guide wire. Then the hole is dilated with dilators using wire
as the guide.
After every tracheostomy, the metal dilator is disinfected. Hence the same metal
dilator can be reused.
Metal instruments are used regularly in surgical procedures. Metal dilator used in
the percutaneous tracheostomy comes in contact with the body for less than 30
seconds therefore causing any harm to human body by the material brass used
for dilators, is not anticipated.
WE CLAIM
1. A metal dilator (A, B, C) for tracheostomy comprising:
a cylindrical metal stem (S1, S2, S3)) with pointed tip (P) at the front,
integral with cylindrical metal neck (N1, N2, N3) at the back having a
shoulder (D) in between the two with holes at back and front;
characterised in that the metal dilator (A,B,C) is autoclaved or disinfected
under higher temperature and pressure and the contour of the pointed tip
(P) is maintained despite repeated deployment of the dilators.
2. A metal dilator as claimed in claim 1, wherein the bigger dilator (A) stem
length (l5) lies between 50-54 mm, neck length (l6) lies between 16.5-17.5
mm, neck diameter (N1) lies between 4-5.5 m and has a hole (h6) at the
back lying between 2.8-3.2 mm and a hole (h8) at the front lying between
0.9-1.1 mm.
3. A metal dilator as claimed in claim 1, wherein the medium dilator (B) stem
length (l3) lies between 33-35.5 mm, neck length (I4) lies between 16.5-
17.5 mm and neck diameter (N2) lies between 4-4.5 m and a hole (h2) at
the front lying between 0.9-1.1 mm and a hole (h5) at the back lying
between 1.5-1.8 mm.
4. A metal dilator as claimed in claim 1, wherein the smaller dilator (C) stem
length (l1) lies between 22.5-23 mm, neck length (l2) lies between 18-18.5
mm and neck diameter (N3) lies between 4-4.5 m and has a hole (h1) at
the front lying between 0.9-1.1 mm and a hole (h4) at the back lying
between 1.5-1.8 mm.
5. A metal dilator as claimed in claim 1, wherein the material of the dilator is
brass.
A metal dilator for tracheostomy is made of brass and consists of a cylindrical
metal stem (S1, S2, S3)) with pointed tip (P) at the front, integral with cylindrical
metal neck (N1, N2, N3) at the back having a shoulder (D) in between the two
with holes at front and back. The metal dilator is autoclaved or disinfected under
higher temperature and pressure and the contour of the pointed tip (P) is
maintained despite repeated deployment of the dilator.
| Section | Controller | Decision Date |
|---|---|---|
| # | Name | Date |
|---|---|---|
| 1 | 1039-KOL-2009-Written submissions and relevant documents (MANDATORY) [15-10-2018(online)].pdf | 2018-10-15 |
| 1 | abstract-1039-kol-2009.jpg | 2011-10-07 |
| 2 | 1039-kol-2009-specification.pdf | 2011-10-07 |
| 2 | 1039-KOL-2009-HearingNoticeLetter.pdf | 2018-09-06 |
| 3 | Correspondence [02-02-2017(online)].pdf | 2017-02-02 |
| 3 | 1039-kol-2009-gpa.pdf | 2011-10-07 |
| 4 | Description(Complete) [02-02-2017(online)].pdf | 2017-02-02 |
| 4 | 1039-kol-2009-form 3.pdf | 2011-10-07 |
| 5 | Description(Complete) [02-02-2017(online)].pdf_267.pdf | 2017-02-02 |
| 5 | 1039-kol-2009-form 2.pdf | 2011-10-07 |
| 6 | Examination Report Reply Recieved [02-02-2017(online)].pdf | 2017-02-02 |
| 6 | 1039-kol-2009-form 18.pdf | 2011-10-07 |
| 7 | Other Document [02-02-2017(online)].pdf | 2017-02-02 |
| 7 | 1039-kol-2009-form 1.pdf | 2011-10-07 |
| 8 | 1039-KOL-2009-FER.pdf | 2016-08-09 |
| 8 | 1039-kol-2009-drawings.pdf | 2011-10-07 |
| 9 | 1039-kol-2009-description (complete).pdf | 2011-10-07 |
| 10 | 1039-KOL-2009-(13-11-2014)-CORRESPONDENCE.pdf | 2014-11-13 |
| 10 | 1039-kol-2009-correspondence.pdf | 2011-10-07 |
| 11 | 1039-kol-2009-abstract.pdf | 2011-10-07 |
| 11 | 1039-kol-2009-claims.pdf | 2011-10-07 |
| 12 | 1039-kol-2009-abstract.pdf | 2011-10-07 |
| 12 | 1039-kol-2009-claims.pdf | 2011-10-07 |
| 13 | 1039-KOL-2009-(13-11-2014)-CORRESPONDENCE.pdf | 2014-11-13 |
| 13 | 1039-kol-2009-correspondence.pdf | 2011-10-07 |
| 14 | 1039-kol-2009-description (complete).pdf | 2011-10-07 |
| 15 | 1039-kol-2009-drawings.pdf | 2011-10-07 |
| 15 | 1039-KOL-2009-FER.pdf | 2016-08-09 |
| 16 | 1039-kol-2009-form 1.pdf | 2011-10-07 |
| 16 | Other Document [02-02-2017(online)].pdf | 2017-02-02 |
| 17 | 1039-kol-2009-form 18.pdf | 2011-10-07 |
| 17 | Examination Report Reply Recieved [02-02-2017(online)].pdf | 2017-02-02 |
| 18 | 1039-kol-2009-form 2.pdf | 2011-10-07 |
| 18 | Description(Complete) [02-02-2017(online)].pdf_267.pdf | 2017-02-02 |
| 19 | Description(Complete) [02-02-2017(online)].pdf | 2017-02-02 |
| 19 | 1039-kol-2009-form 3.pdf | 2011-10-07 |
| 20 | Correspondence [02-02-2017(online)].pdf | 2017-02-02 |
| 20 | 1039-kol-2009-gpa.pdf | 2011-10-07 |
| 21 | 1039-kol-2009-specification.pdf | 2011-10-07 |
| 21 | 1039-KOL-2009-HearingNoticeLetter.pdf | 2018-09-06 |
| 22 | abstract-1039-kol-2009.jpg | 2011-10-07 |
| 22 | 1039-KOL-2009-Written submissions and relevant documents (MANDATORY) [15-10-2018(online)].pdf | 2018-10-15 |