U.S. patent application number 16/833458 was filed with the patent office on 2020-08-06 for intubating airway device.
The applicant listed for this patent is Muhammed Aslam INTERSURGICAL AG Nasir. Invention is credited to Jane Elizabeth Kemp, Andrew Neil Miller, Muhammed Aslam Nasir.
Application Number | 20200246569 16/833458 |
Document ID | / |
Family ID | 50031062 |
Filed Date | 2020-08-06 |
![](/patent/app/20200246569/US20200246569A1-20200806-D00000.png)
![](/patent/app/20200246569/US20200246569A1-20200806-D00001.png)
![](/patent/app/20200246569/US20200246569A1-20200806-D00002.png)
![](/patent/app/20200246569/US20200246569A1-20200806-D00003.png)
![](/patent/app/20200246569/US20200246569A1-20200806-D00004.png)
United States Patent
Application |
20200246569 |
Kind Code |
A1 |
Nasir; Muhammed Aslam ; et
al. |
August 6, 2020 |
INTUBATING AIRWAY DEVICE
Abstract
An airway device for human or animal use includes an airway tube
having a first end and a second end, the first end of which is
surrounded by a laryngeal cuff configured to fit over the laryngeal
inlet of a patient when in situ. The first end of the airway tube
is provided with an intubating ramp configured to direct a tube
inserted through the airway tube into the laryngeal inlet of the
patient when in situ.
Inventors: |
Nasir; Muhammed Aslam;
(Bedfordshire, GB) ; Kemp; Jane Elizabeth;
(Bristol, GB) ; Miller; Andrew Neil; (Crowthorne,
GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Nasir; Muhammed Aslam
INTERSURGICAL AG |
Bedfordshire
Vaduz |
|
GB
LI |
|
|
Family ID: |
50031062 |
Appl. No.: |
16/833458 |
Filed: |
March 27, 2020 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
15106239 |
Jun 17, 2016 |
10625037 |
|
|
PCT/GB2014/053744 |
Dec 17, 2014 |
|
|
|
16833458 |
|
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0488 20130101;
A61M 16/0415 20140204; A61M 16/0463 20130101; A61M 16/0409
20140204; A61M 16/0443 20140204; A61M 2250/00 20130101; A61M
16/0497 20130101; A61M 16/0436 20140204; A61M 16/0438 20140204;
A61M 16/0445 20140204 |
International
Class: |
A61M 16/04 20060101
A61M016/04 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 17, 2013 |
GB |
1322328.4 |
Claims
1. An airway device for human or animal use comprising an airway
tube having a first end and a second end, the first end of which is
surrounded by a laryngeal cuff configured to fit over the laryngeal
inlet of a patient when in situ, wherein the first end of the
airway tube is provided with an intubating ramp configured to
direct a tube inserted through the airway tube into the laryngeal
inlet of the patient when in situ wherein the intubating ramp is
provided with a groove which runs longitudinally along the full
length of the intubating ramp from the first end to the second end
of the longitudinal ramp.
2. The airway device as claimed in claim 1 wherein the intubating
ramp is provided on the internal wall of the dorsal side of the
airway tube.
3. The airway device as claimed in claim 1 wherein the first end of
the airway tube is of greater diameter than the remainder of the
airway tube.
4. The airway device as claimed in claim 1 wherein the internal
wall of the ventral side of the airway tube is flattened.
5. The airway device as claimed in claim 1 wherein the intubating
ramp is provided with a plurality of grooves.
6. The airway device as claimed in claim 1 wherein the tip of the
laryngeal cuff is elongate.
7. The airway device as claimed in claim 1 wherein the tip of the
laryngeal cuff is provided with a protrusion on the back dorsal
side thereof.
8. The airway device as claimed in claim 1 wherein a side wall of
the second end of the airway tube is provided with a supplementary
gas inlet.
9. The airway device as claimed in claim 1 wherein the first end of
the airway tube is of widened diameter or flared.
10. The airway device as claimed in claim 2 wherein the first end
of the airway tube is of greater diameter than the remainder of the
airway tube.
11. The airway device as claimed in claim 2 wherein the internal
wall of the ventral side of the airway tube is flattened.
12. The airway device as claimed in claim 2 wherein the intubating
ramp is provided with a plurality of grooves.
13. The airway device as claimed in claim 2 wherein the tip of the
laryngeal cuff is elongate.
14. The airway device as claimed in claim 2 wherein the tip of the
laryngeal cuff is provided with a protrusion on the back dorsal
side thereof.
15. The airway device as claimed in claim 2 wherein a side wall of
the second end of the airway tube is provided with a supplementary
gas inlet.
16. The airway device as claimed in claim 3 wherein the first end
of the airway tube is of widened diameter or flared.
17. The airway device as claimed in claim 3 wherein the internal
wall of the ventral side of the airway tube is flattened.
18. The airway device as claimed in claim 3 wherein the intubating
ramp is provided with a plurality of grooves.
19. The airway device as claimed in claim 3 wherein the tip of the
laryngeal cuff is elongate.
20. The airway device as claimed in claim 3 wherein the tip of the
laryngeal cuff is provided with a protrusion on the back dorsal
side thereof.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of U.S. patent application
Ser. No. 15/106,239, filed Jun. 17, 2016, which in turn was a 371
application of PCT/GB2014/053744, FILED Dec. 17, 2014.
FIELD OF THE INVENTION
[0002] The present invention relates to medical devices and is
applicable to laryngeal airway devices and to their methods of
manufacture. It is particularly applicable to devices used in the
administration of Oxygen and/or anaesthetic gases to a human or
veterinary patient breathing spontaneously, for Intermittent
Positive Pressure Ventilation (IPPV) during a surgical procedure or
resuscitation and for intubating patients during such
procedures.
BACKGROUND TO THE INVENTION
[0003] GB2393399 (Nasir) describes an airway device comprising an
airway tube having a first end and a second end, the first end of
which is surrounded by a non-inflatable laryngeal cuff which forms
an anatomical fit over the laryngeal inlet of a patient and a
buccal cavity stabiliser located on or around the airway tube
between the laryngeal cuff and the second end of the tube, the
buccal stabiliser being adapted to prevent rotational or
side-to-side movement of the airway device in use.
[0004] Whilst such airway devices provide a significant improvement
over the use of inflatable cuff airway devices, it is still
sometimes necessary to intubate a patient during a procedure.
[0005] A number of attempts have been made to provide for an airway
device which not only forms an external seal around the laryngeal
inlet of the patient, but also serves as a guide to allow for the
insertion of an endotracheal tube. However, such devices have
always been inflatable, do not always provide for the endotracheal
tube to be guided directly into the laryngeal inlet and instead can
direct the endotracheal tube into the oesophagus of the patient,
and can cause the airway tube of the airway device to become
blocked cutting off the air supply to the patient.
SUMMARY OF THE INVENTION
[0006] A first aspect of the present invention provides an airway
device as described in the accompanying claims.
[0007] Accordingly, according to a first aspect of the present
invention, there is provided an airway device for human or animal
use comprising an airway tube having a first end and a second end,
the first end of which is surrounded by a laryngeal cuff configured
to fit over the laryngeal inlet of a patient when in situ, wherein
the first end of the airway tube is provided with an intubating
ramp configured to direct a tube inserted through the airway tube
into the laryngeal inlet of the patient when in situ. Preferably
the tube is an endotracheal tube.
[0008] In prior art devices such as that described in GB2393399
(Nasir), and as illustrated in FIG. 1, when an endotracheal tube is
inserted through the airway tube, the endotracheal tube, instead of
following its natural curve (which allows for correct insertion of
the endotracheal tube into the laryngeal inlet), follows the
curvature of the airway tube of the airway device. This often leads
to the endotracheal tube, instead of entering the laryngeal inlet,
sliding along the inside of the laryngeal cuff towards the tip of
the device which can result in contact between the endotracheal
tube and the larynx of the patient, and even insertion of the
endotracheal tube into the oesophagus of the patient, both of which
are undesirable.
[0009] However, in the present invention the airway device is
provided with an intubating ramp which ensures that the
endotracheal tube, when inserted through the airway tube, follows
its natural curve, rather than the curve of the airway tube, and
guides the endotracheal tube into the laryngeal inlet of the
patient when the airway device is in situ in a patient.
[0010] Preferably the intubating ramp is provided on the internal
wall of the dorsal side of the airway tube. In the alternative the
intubating ramp is provided on the internal surface of the dorsal
side of the laryngeal cuff. Preferably the ramp is angled to ensure
that when the tube is inserted through the airway tube when the
device is in situ in a patient. It exists the device higher up in
the anatomy of the patient and is guided into the laryngeal inlet
of the patient.
[0011] Preferably in addition to the intubating ramp, the first end
of the airway tube is of greater diameter and thus wider than the
remainder of the airway tube. In particular it is preferred that
the internal surface of the ventral side of the airway tube is
flattened rather than curved to provide this widening. This further
enables the endotracheal tube, when inserted through the airway
tube, to follow its natural curve, rather than the curve of the
airway tube, and works in combination with the intubating ramp.
Essentially what is created by the widening is a flaring at the
first end of the airway tube as the airway tube emerges into the
rear of the cuff.
[0012] Preferably the intubating ramp is provided with a channel or
groove. Preferably the channel or groove runs longitudinally along
the full length of the intubating ramp from the first end to the
second end of the longitudinal ramp. More preferably the intubating
ramp is provided with a plurality of channels or grooves. The
provision of the intubating ramp reduces the depth of the internal
cavity of the laryngeal cuff, this means that should the device be
sub-optimally inserted that there is risk that the airway of the
patient could become partially occluded. The provision of the one
or more channel(s) or groove(s) ensures the patency of the airflow
through the airway device into the airway of the patient without
compromising the effect of the ramp.
[0013] Preferably the tip of the laryngeal cuff is elongate.
Preferably the tip of the laryngeal cuff is provided with a
protrusion or bump on the back dorsal side thereof. The elongate
nature of the tip of the laryngeal cuff along with the dorsal
protrusion or bump both assist to provide an improved oesophageal
seal when the airway device is in situ in the patient. By providing
an improved oesophageal seal there is reduced risk of inflation of
the stomach of the patient, and a reduced risk of regurgitation
entering into the airway of the patient.
[0014] Preferably a side wall of the second end of the airway tube
is provided with a supplementary gas inlet. The supplementary gas
inlet allows for additional oxygen or other gas to be provided to
the patient if required. A suitable supplementary gas inlet has
been described in WO2011131974 (Miller).
[0015] Preferably the cuff is non-inflatable and is pre-formed in a
shape adapted to form an anatomical fit over the laryngeal
framework of a patient.
[0016] Preferably the laryngeal cuff is pre-formed, pre-inflated
with air or pre-filled with a suitable fluid. Most preferably the
laryngeal cuff is non-inflatable, however in the alternative the
laryngeal cuff can be inflatable.
[0017] In one alternative the airway device further comprises a
buccal cavity stabiliser located on or around the airway tube
between the laryngeal cuff and the second end of the tube. The
buccal cavity stabiliser, if provided, may be formed from the same
material as the cuff or from a different material and assists in
locating and maintaining the position of the device in use.
[0018] In a particularly preferred embodiment the buccal cavity
stabiliser, if provided, is formed as an integral part of the
airway tube, and further preferably the buccal cavity stabiliser,
the airway tube and the laryngeal cuff are all formed as an
integral unit.
[0019] In a further alternative no buccal cavity stabiliser is
provided.
[0020] The Shore hardness of the various, parts, portions or
components is an important feature of the invention. For example,
the laryngeal cuff is preferably formed from a material with a
Shore hardness on the A scale of 40 or less and more preferably 000
to 20, and most preferably 000 to 4.
[0021] Preferably the laryngeal cuff and a front, ventral part of
the buccal cavity stabiliser, if provided, are formed from a
material of substantially the same Shore hardness. This simplifies
construction and ensures that all portions of the device that come
into firm contact with the patient's soft tissue are relatively
soft.
[0022] In a further preferred embodiment a back or dorsal part of
the device and a front or ventral part of the device are formed
from materials of different Shore hardness. This enables the dorsal
portion to be made of a firmer material than the ventral
portion.
[0023] Preferably the back or dorsal part of the device is formed
from a material of Shore hardness less than 60 on the A scale, more
preferably 25 to 45, and most preferably 30 to 40.
[0024] Preferably the device further incorporates a gastric tube
passageway extending from the tip of the cuff to the second end of
the airway device.
[0025] According to a second aspect of the invention there is
provided an airway device for human or animal use comprising an
airway tube having a first end and a second end, the first end of
which is surrounded by a laryngeal cuff configured to fit over the
laryngeal inlet of a patient when in situ, wherein the first end of
the airway tube is of widened diameter or flared.
BRIEF DESCRIPTION OF THE DRAWINGS
[0026] The invention will now be described, by way of example only,
with reference to the accompanying drawings in which:--
[0027] FIG. 1 illustrates a part cross-sectional view of the
laryngeal cuff of the prior art;
[0028] FIG. 2 illustrates a part cross-sectional view of the
laryngeal cuff according to a first embodiment;
[0029] FIG. 3 illustrates a front ventral perspective view of the
laryngeal cuff according to a first embodiment;
[0030] FIG. 4 illustrates a side view of the laryngeal cuff
according to a first embodiment;
[0031] FIG. 5 illustrates a back dorsal view of the laryngeal cuff
according to a first embodiment;
[0032] FIG. 6 illustrates a side view of the supplementary gas
inlet according to a first embodiment; and
[0033] FIG. 7 illustrates a side view of the airway device
according to a first embodiment.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0034] Embodiments of the present invention are described below by
way of example only. These examples represent the best ways of
putting the invention into practice that are currently known to the
applicant although they are not the only ways in which this could
be achieved.
[0035] Referring to FIGS. 2 to 7, these illustrate an airway device
10 according to a first embodiment of the invention. The airway
device 10 has an airway tube 12 having a first end 14 and a second
end 16. The second end 16 optionally terminates in a 15 mm or other
connector 18 suitable for connection to an anaesthetic breathing
system of conventional type. Formed around the first end 14 of the
airway tube is a laryngeal cuff 20. In the embodiment illustrated
the laryngeal cuff 20 is non inflatable and is adapted in its shape
and contours to correspond with the laryngeal inlet region of a
patient.
[0036] The first end 14 of the airway tube 12 is also provided with
an intubating ramp 22 configured to direct an endotracheal tube (or
another other applicable tube or device) inserted through the
airway tube 12 into the laryngeal inlet of the patient when the
airway device 10 is in situ within a patient. The intubating ramp
22 ensures that the endotracheal tube, when inserted through the
airway tube, follows its natural curve, rather than the curve of
the airway tube 12, and guides the endotracheal tube into the
laryngeal inlet of the patient when the airway device 10 is in situ
in a patient.
[0037] In the embodiment illustrated the intubating ramp 22 is
provided on the internal wall of the back dorsal side of the airway
tube 12. In the alternative the intubating ramp 22 can instead be
provided on the internal surface of the back dorsal side of the
laryngeal cuff 20.
[0038] In addition to the provision of intubating ramp 22, the
first end 14 of the airway tube 12 is of greater diameter and thus
wider than the remainder of the airway tube 12. In the embodiment
illustrated the internal surface of the front ventral side 24 of
the airway tube 12 is flattened rather than curved to provide this
widening. This further enables the endotracheal tube, when inserted
through the airway tube 12, to follow its natural curve, rather
than the curve of the airway tube 12 and works in combination with
the intubating ramp 22.
[0039] In the embodiment illustrated the intubating ramp 22 is
optionally provided with two channels 26, 28 that run
longitudinally along the full length of the intubating ramp 22 from
the first end to the second end thereof. The provision of the
intubating ramp 22 reduces the depth of the internal cavity of the
laryngeal cuff 20, this means that should the airway device 10 be
sub-optimally inserted that there is risk that the airway of the
patient could become partially occluded. The provision of the
channels 26, 28 ensures the patency of the airflow through the
airway device 10 into the airway of the patient without
compromising the effect of the intubating ramp 22.
[0040] In the embodiment illustrated the tip 30 of the laryngeal
cuff 20 is elongate compared to the prior art device illustrated in
FIG. 1. In addition the tip 30 of the laryngeal cuff 20 is provided
with a protrusion or bump 32 on the back dorsal side thereof. The
elongate nature of the tip 30 of the laryngeal cuff 20 along with
the dorsal protrusion or bump 32 both assist to provide an improved
oesophageal seal when the airway device 10 is in situ in the
patient. By providing an improved oesophageal seal there is reduced
risk of inflation of the stomach of the patient, and a reduced risk
of regurgitation entering into the airway of the patient.
[0041] In addition in the embodiment illustrated a side wall of the
second end 16 of the airway tube 12 has been provided with an
optional supplementary gas inlet 34, more particularly the
supplementary gas inlet 34 is formed as part of connector 18,
however in the alternative it may be separate from connector 18.
The supplementary gas inlet 34 allows for additional oxygen or
other gas to be provided to the patient if required.
[0042] In one alternative the laryngeal cuff is non-inflatable and
is formed from any suitable soft plastics material. By way of a
preferred softness (hardness) range, on the Shore A scale of
Hardness, a hardness of less than 40 for the face of the laryngeal
cuff that contacts the laryngeal inlet is optimum. By way of a
preferred range, a value on the same scale of 000 to 20 is
preferred, with a particularly preferred range of 000 to 4. The
softness of the laryngeal cuff can be further adapted by forming
cavities or channels within the body of the cuff itself.
[0043] In a further alternative the laryngeal cuff may be
pre-filled with a fluid such as air, or other non-toxic gas, or a
non-toxic liquid. In this context the term fluid has a broad
meaning and includes any suitable gas, liquid, vapour or
combination thereof and will be determined and designed by an
expert in this field of anatomy/anaesthesia in conjunction with the
materials specialist. The laryngeal cuff will be constructed of
such a material which will not allow nitrous oxide (anaesthetic
gas) to diffuse through the material to any significant amount so
that the extra luminal pressure is kept constant. It follows
therefore that the laryngeal cuff should be substantially
impermeable to the fluid with which is filled and to anaesthetic
gases.
[0044] Alternatively, the laryngeal cuff can be formed from a soft,
foamed material or can be foam filled. In either case this provides
a soft deformable but shaped surface around the face of the
laryngeal cuff to engage over the anatomy of the larynx inlet
region. Such a foam filled device will minimise any potential
damage to the structures in that region whilst still providing a
substantially complete seal.
[0045] Further in the alternative the laryngeal cuff is pre-filled
during manufacture with a fluid in which case the lining of the
cuff should be made from a material that does not absorb
anaesthetic gases such as Nitrous Oxide, such that the pressure
inside the cuff does not rise during use.
[0046] In another alternative the laryngeal cuff may be formed from
a material which is adapted to absorb a liquid, such as water,
mucous or blood or similar liquid material and in doing so to swell
in size so as to confirm to the anatomical mucocartilagenous
framework of the patient's laryngeal inlet. Such materials will be
selected by the materials specialist but include CRM (cotton rayon
mixes) as used in TAMPAX.RTM. tampons, or compressed Gel Foam
5.
[0047] In a further, alternative, the laryngeal cuff could take the
form of a conventional, inflatable laryngeal cuff. The technology
to form an inflatable laryngeal cuff is well known and need not be
described here.
[0048] Finally, in yet another alternative, the laryngeal cuff may
be hollow, but not inflatable in the traditional sense of the word,
and instead Positive Pressure Ventilation is employed to "inflate"
and self-pressurise the laryngeal cuff.
[0049] Also in the embodiment illustrated a buccal cavity
stabiliser 36 has been provided around the airway tube 12 between
the laryngeal cuff 20 and the second end 16 of the airway tube 12.
The buccal cavity stabiliser 36 assists in locating and maintaining
the position of the airway device 10 in use.
[0050] In the embodiment illustrated the buccal cavity stabiliser
36 is formed as an integral part of the airway tube 12, and further
preferably the buccal cavity stabiliser 38, the airway tube 12 and
the laryngeal cuff 20 are all formed as an integral unit.
[0051] In an alternative, no buccal cavity stabiliser 36 is
provided.
[0052] A gastric tube passageway 38, separate to the airway tube 12
is provided which runs from an opening in the second end of the
device near the connector 18 if provided to an opening in the tip
of the cuff 20. The gastric tube passageway 38 allows for any
gastric aspirate to be detected in the event of passive
regurgitation during use. It also provides a route for the
insertion of small-bore gastric tubes (e.g., Freka Tubes).
[0053] The device may be constructed from any suitable plastics
material as selected by the materials specialist. Latex-free
medical grade silicone rubber is one preferred material. The cuff
should be soft in texture to avoid undue damage to the surrounding
tissue. Other suitable materials for construction of this type of
device include, but are not limited to, Poly Vinyl Chloride (PVC),
Thermoplastic Elastomers such as the styrenic block copolymers (eg
Styrene Butadiene Styrene (SBS), Styrene Ethylene Butylene Styrene
(SEBS)), and Thermoplastic Olefin Blends (TPO), Thermoplastic
PolyUrethanes (TPU), Copolyester (COPE), Polyether Block Amides
(PEBAX) and foamed versions thereof, where appropriate.
[0054] A further important factor involved in the choice of a
suitable material is transparency. Ideally the material or
materials of construction should be substantially clear or
transparent. This enables the anesthetist or operator to see the
inner lumen of the airway to check for blockages or other problems.
Such transparent materials are known to the materials
specialist.
* * * * *