U.S. patent application number 14/926009 was filed with the patent office on 2016-02-18 for introducer guide.
The applicant listed for this patent is AIRCRAFT MEDICAL LIMITED. Invention is credited to Peter Douglas Colin INGLIS, Matthew John Ross MCGRATH.
Application Number | 20160045103 14/926009 |
Document ID | / |
Family ID | 40580634 |
Filed Date | 2016-02-18 |
United States Patent
Application |
20160045103 |
Kind Code |
A1 |
MCGRATH; Matthew John Ross ;
et al. |
February 18, 2016 |
INTRODUCER GUIDE
Abstract
An introducer guide for an intubation device having an open
channel adapted to releasably secure an introducer, and shaped such
that advancement of an intubation tube through which the introducer
extends causes the introducer to be removed from the introducer
guide.
Inventors: |
MCGRATH; Matthew John Ross;
(EDINBURGH, GB) ; INGLIS; Peter Douglas Colin;
(EDINBURGH, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AIRCRAFT MEDICAL LIMITED |
EDINBURGH |
|
GB |
|
|
Family ID: |
40580634 |
Appl. No.: |
14/926009 |
Filed: |
October 29, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13254575 |
Nov 15, 2011 |
9174014 |
|
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PCT/GB2010/050378 |
Mar 3, 2010 |
|
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14926009 |
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Current U.S.
Class: |
600/194 ;
600/185 |
Current CPC
Class: |
A61B 1/267 20130101;
A61M 16/0411 20140204; A61M 16/0418 20140204; A61M 16/0488
20130101 |
International
Class: |
A61B 1/267 20060101
A61B001/267 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 3, 2009 |
GB |
0903743.3 |
Claims
1. Introducer guide means for an intubation device, the introducer
guide means having an operating configuration in which the
introducer guide means defines an open channel adapted to
releasably secure in position an introducer in the open channel,
the channel having first and second ends respectively upstream and
downstream of the deployment direction of the introducer wherein
the first end is shaped to contact an intubation tube so as to
cause the intubation tube to remove the introducer from the
introducer guide means, the first end comprising a tube deflecting
formation in the form of a gradual incline operable to deflect an
intubation tube through which an introducer retained in the open
channel of the introducer guide means extends as the intubation
tube is advanced to engage with the tube deflecting formation.
2. Introducer guide means according to claim 1, wherein the open
channel is elongate and is defined by walls, one or more of which
are deformable.
3. Introducer guide means according to claim 2, wherein one or more
walls are elastically deformable.
4. Introducer guide means according to claim 2, wherein one or more
walls comprises or consists of a hinged guiding member.
5. Introducer guide means according to claim 1, wherein the first
end of the guide means comprises walls which extend at an angle of
less than 60.degree. to the length of the guide means.
6. Introducer guide means according to claim 1, comprising means
for attachment to a suitable medical device.
7. A blade portion of an intubation device and introducer guide
means according to claim 1, said introducer guide means being
demountably attachable to or integral to the blade portion.
8. An intubation device and a blade portion according to claim 7,
demountably attachable to or integral to the intubation device.
9. An intubation device according to claim 8, which is a
laryngoscope.
10. A kit comprising apparatus according to claim 1 and an
intubation tube having a diameter sufficiently large to not extend
through the introducer guide means.
11. A method of intubating a patient, comprising the step of
introducing an intubation device according to claim 8 into a
patient, with an introducer extending through an intubation tube
and the introducer guide means, and then advancing an intubation
tube towards the introducer guide means such that the introducer
guide means causes the introducer to be removed from the introducer
guide means.
12. Introducer guide means for an intubation device, the introducer
guide means having an operating configuration in which the
introducer guide means defines an open channel adapted to
releasably secure in position an introducer in the open channel,
the channel having first and second ends respectively upstream and
downstream of the deployment direction of the introducer wherein
the first end is shaped to contact an intubation tube so as to
cause the intubation tube to remove the introducer from the
introducer guide means, wherein the introducer guide means also has
a flattened configuration in which one or more members which define
the open channel in the operating configuration are folded against
a base portion of the guide means.
13. Introducer guide means according to claim 12, wherein one or
more walls comprises or consists of a hinged guiding member.
14. Introducer guide means according to claim 12, wherein the first
end of the introducer guide means comprises a tube deflecting
formation operable to deflect an intubation tube through which an
introducer retained in the open channel of the introducer guide
means extends as the intubation tube is advanced to engage with the
tube deflecting formation.
15. Introducer guide means according to claim 12, wherein the first
end of the guide means comprises walls which extend at an angle of
less than 60.degree. to the length of the guide means.
16. Introducer guide means according to claim 12, comprising means
for attachment to a suitable medical device.
17. A blade portion of an intubation device and introducer guide
means according to claim 12, said introducer guide means being
demountably attachable to or integral to the blade portion.
18. An intubation device and a blade portion according to claim 17
demountably attachable to or integral to the intubation device.
19. An intubation device according to claim 18, which is a
laryngoscope.
20. A kit comprising apparatus according to claim 18 and an
intubation tube having a diameter sufficiently large to not extend
through the introducer guide means.
21. A method of intubating a patient, comprising the step of
introducing an intubation device according to claim 18 into a
patient, with an introducer extending through an intubation tube
and the introducer guide means, and then advancing an intubation
tube towards the introducer guide means such that the introducer
guide means causes the introducer to be removed from the introducer
guide means.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a Continuation application of
application Ser. No. 13/254,575, filed on Sep. 2, 2011, which is
the U.S. national phase of International Application No.
PCT/GB2010/050378, filed 3 Mar. 2010, which designated the U.S. and
claims priority to GB Application No. 0903743.3, filed 3 Mar. 2009,
the entire contents of each of which are hereby incorporated by
reference.
FIELD OF THE INVENTION
[0002] The present invention relates to the field of introducer
guides for assisting intubation procedures and intubation devices,
such as laryngoscopes, including introducer guides.
BACKGROUND TO THE INVENTION
[0003] Endotracheal intubation, in which a tube is passed via the
mouth or nose, through the larynx and into the trachea, is an
important procedure in providing a positive airway in general
medical practice to allow for the administration of anaesthesia or
to provide air to the lungs. Endotracheal intubation may need to be
performed for a variety of reasons, such as in the treatment of
comatose patients where airways are liable to collapse due to
reduced muscle tone, or, for example, in general anaesthesia
wherein spontaneous respiration may be decreased or absent. In many
of these cases, intubation tubes will need to be inserted by
doctors or paramedics to unconscious patients in emergency
situations. The procedure is further complicated by the risk of
damage to the patient's teeth and the soft tissue of the throat.
Considerable skill is therefore required when inserting an
endotracheal tube in order to ensure that intubation is carried out
in the quickest manner possible, without causing injury to the
patient.
[0004] Endotracheal intubation is conventionally performed via
direct laryngoscopy, in which a laryngoscope is used to restrain
the patient's tongue and displace the epiglottis. This allows for
direct visualisation of the larynx and the entrance to the trachea
through the oral cavity, along with a clear passageway so that
intubation may be more easily performed.
[0005] Traditional laryngoscopes comprise an elongate rigid blade,
which may be curved or straight, extending from a handle, and
typically include a light source, to illuminate the area of
interest. In use, the laryngoscope blade is inserted through the
oral cavity into the pharyngeal area, displacing the tongue and
epiglottis. Once the laryngoscope is in position, an endotracheal
tube is then inserted, via the nose or the oral cavity, alongside
the laryngoscope blade and past the displaced epiglottis. Video
laryngoscopes, employing a video camera located on or in the blade,
or connected through a fibre optic bundle to a location on or in
the blade, can provide further assistance when guiding the
intubation tube into a patient's trachea.
[0006] Whilst visualisation of the intubation procedure has
improved, the process of guiding the intubation tube into the
trachea is still relatively cumbersome. The main problem with
current intubation procedures is the difficulty in placing the
tube. Various adjuncts, such as introducers, are known in the art
for aiding this procedure as the introducer can be inserted prior
to the more cumbersome intubating tube. However, there are still
many cases where the introducer is accidentally placed into the
oesophagus rather than the trachea, causing problems.
[0007] Introducers are firm guides, typically of small
circumference, which are inserted into the larynx of the patient.
Once the introducer is in place, the larger intubation tube is
inserted over the introducer into the trachea. The introducer is
then slidably removed from the trachea leaving the outer intubation
tube in position. As introducers have some flexibility and/or
malleability, they are particularly useful adjuncts to the
intubation procedure when only part of the larynx is visible or
when only the epiglottis can be seen. In use, the difference
between the external diameter of the introducer and the internal
diameter of the outer intubation tube should be fairly small as
when greater differences between these diameters exist, the outer
intubation tube can drag the introducer out of the airway. An
example of a commonly used introducer is the Eschmann tracheal tube
introducer (gum elastic bougie). This is a 60 cm long, 15 French
Gauge flexible device with a J (coude) angle at its distal tip.
This bougie can be passed into the trachea and, due to its flexible
and malleable nature, is considered to be relatively atraumatic for
the patient. The coude (bent) tip can also be used to sense the
tracheal rings and thus to ensure that the bougie has not entered
the oesophagus.
[0008] In order to direct the insertion of an intubation tube, it
is known to provide guide means, for use with a laryngoscope blade.
These guide means typically comprise a tube guide, for example, one
or more channels which are of a sufficient diameter to house the
intubation tube, and which are integrally formed with, or attached
to the laryngoscope blade. Such guide channels typically extend
along the majority of the length of the laryngoscope blade. It is
also known from WO 2009/027669 (Aircraft Medical Limited) to
provide a tube guide using spaced apart tube guiding members,
reducing bulk.
[0009] In use, the intubation tube is inserted into the tube guide,
and directed along its length into the trachea. Whilst this is a
simple and effective means for introducing an intubation tube, in
order to remove the laryngoscope and bougie once the intubation
tube is in place, the laryngoscope blade must be slid back along
the inserted tube towards the oral cavity, in order to separate the
blade from the inserted tube. This is an awkward procedure as it
requires the practitioner to hold both the laryngoscope and the
inserted tube while withdrawing the blade, and can also be
time-consuming, which is a significant disadvantage for a technique
which is commonly used for medical procedures in which time can be
of vital importance.
[0010] Furthermore, as the intubation tube is relatively large,
some tube guides are very bulky. The size of the tube also obscures
a user's view, even in cases where the laryngoscope is provided
with video imaging, making insertion difficult. This is why
introducers are often used to assist insertion but these are
typically not guided into place.
[0011] The present invention provides improved guide means (such as
a tube guide) which mitigates one or more of the limitations
previously discussed.
[0012] Throughout this document the term blade portion should be
read in a broad sense to cover not only laryngoscope blades but
also to cover speculums or elements that are inserted into body
cavities. Furthermore, whilst the term "bougie" is used throughout
the specification, it will be understood that this is simply one
example of a suitable introducer and that any suitable introducer
is encompassed by the term.
SUMMARY OF THE INVENTION
[0013] According to a first aspect of the invention there is
provided guide means (typically, an introducer guide) for an
intubation device (for example, a laryngoscope), the guide means
having an operating configuration in which the guide means defines
an open channel adapted to releasably secure in position an
introducer, the channel having first and second ends respectively
upstream and downstream of the deployment direction of the
introducer wherein the first end is shaped to contact an intubation
tube so as to cause the intubation tube to remove the introducer
from the guide means (typically, the introducer guide).
[0014] By the reference to an operating configuration we include
the possibility that, in some embodiments, the guide means may have
a plurality of configurations. For example, the guide means may
also have a flattened configuration in which one or more members
which define the open channel in the operating configuration are
folded against a base portion of the guide means. However, the
guide means may have only the operating configuration.
[0015] Thus, for the avoidance of doubt, the invention extends in a
second aspect to a guide means (typically, an introducer guide) for
an intubation device (for example, a laryngoscope), the guide means
comprising an open channel adapted to releasably secure in position
an introducer, the channel having first and second ends
respectively upstream and downstream of the deployment direction of
the introducer wherein the first end is shaped to contact an
intubation tube so as to cause the intubation tube to remove the
introducer from the guide means (typically, the introducer
guide).
[0016] An intubation tube extends around the introducer in use
(that is to say, the intubation tube has a bore and the introducer
extends through the bore). The intubation tube may extend around
the introducer when the introducer is first secured in the open
channel. However, an intubation tube may be fitted around the
introducer after the introducer has been secured in the open
channel, and optionally after the introducer has been guided to its
final location within a patient.
[0017] Advantageously, as the shaped first end of the guide means
causes the intubation tube to contact the introducer and release it
from the guide means, as the endotracheal tube is advanced, it
removes the necessity to wrest the introducer from the guide means
by alternative methods, such as by the medical practitioner
imparting a violent sideways jerking motion which could result in
injury to the patient.
[0018] Preferably the guide means comprises an open channel, which
may be continuous or discontinuous. A discontinuous open channel
may be defined by one or more suitable arranged (e.g. aligned)
elements (e.g. tube guiding members).
[0019] Preferably, the guide means comprises a channel with a
longitudinal portion which is permanently open. For example, the
guide means may comprise an open channel defined by rigid
walls.
[0020] The guide means comprises a channel with a longitudinal
portion which is deformable such that it opens to release the
introducer. For example, the guide means may comprise an elongate
channel defined by walls, one or more of which are elastically
deformable.
[0021] The guide means may comprise one or more walls which are
deformable. For example, the guide means may be formed of an
elastically deformable material (for example, it may comprise or
consist of a tube guide defined by resilient walls). One or more
walls may comprise or consist of a hinged guiding member. The
hinged guiding member may be resiliently biased.
[0022] In this case, the material of the guide means can be
deformed, allowing the guide means to hold the introducer in
position, but to release the introducer upon the application of a
gentle pressure as the intubation tube which surrounds the
introducer pulls it away from the guide means. The guide means may
be resiliently biased such that when the guide means is in the
original undeformed state, the walls of the guide means are
sufficiently close together to hold the introducer in position, and
the guide means resiliently returns to this position once the
introducer has been released such that the guide means can be
reusable.
[0023] Optionally, the guide means is formed of a rigid or
semi-rigid material.
[0024] However, the hinged guiding member may be operable between a
flattened configuration in which the guide means cannot retain a
tube guide and the operating configuration in which the hinged
guiding member and at least one other guiding member (for example,
a wall) together form guide means operable to releasably secure in
position an introducer, the first end of which is shaped to contact
an intubation tube so as to cause the intubation tube to remove the
introducer from the guide means. This may enable a user to select
whether to use the guide means (by putting the guide means into the
operating configuration before use) or not (in which case, the
hinged guiding member is conveniently stowed in a flattened
configuration, minimising the bulk which it presents).
[0025] The first end of the guide means may comprise a tube
deflecting formation operable to deflect an intubation tube through
which an introducer retained with the guide extends as the
intubation tube is advanced to engage with the tube deflecting
formation.
[0026] The first end of the guide means may have a gradual incline.
The first end of the guide means may comprise walls which extend at
an angle of less than 60.degree., and preferably less than
45.degree. or less than 30.degree. to the length of the guide
means. Preferably the first end of the guide means has a smooth
taper.
[0027] Preferably, the internal diameter of the guide means is
smaller than the outer diameter of the intubation tube.
[0028] Advantageously, as the internal diameter of the guide means
is smaller than the outer diameter of the intubation tube, the
intubation tube cannot enter into the guide means. Thus the
continued forward motion of the intubation tube causes the course
of the intubation tube to be diverted when it comes into contact
with the shaped first end of the guide means.
[0029] The guide means may comprise means for attachment to a
suitable medical device.
[0030] Preferably the medical device is a spatulate device. By
spatulate device herein is meant any medical device having an
element, such as a broad flat end, which can be inserted into a
body cavity. The medical device is typically an intubation device,
such as a laryngoscope. In this case, the intubation tube is
typically an endotracheal tube. The laryngoscope may be a video
laryngoscope comprising an imaging device (such as a video camera
or a lens through which light is received and guided through fibre
optics to a video camera) and the guide means may be arranged
laterally of the imaging device so that the positioning of the
introducer and advancement of an intubation tube distally of the
blade portion may be observed during use.
[0031] Preferably, the means for attachment comprises a mating
formation (for example, a groove) which enables it to be fitted to
the blade portion of a suitable medical device (typically, by
attachment to a cooperating formation on the blade portion). More
preferably, the guide means comprises means for attachment to a
laryngoscope blade.
[0032] Optionally, the guide means may be integrally formed with a
medical device. The medical device is typically an intubation
device and the guide means may be integrally formed with the blade
portion of a laryngoscope. The blade portion may be integral with,
or demountable from, a laryngoscope body.
[0033] Advantageously, as the device encourages separation of the
introducer from the medical device in situ, there is no requirement
to slide the device back along the tube towards the point of entry
in order to remove the device once the tube is in position in the
body cavity.
[0034] In a third aspect, the invention extends to a blade portion
of an intubation device (for example a laryngoscope blade) and
guide means according to the first or second aspect of the
invention. The guide means may be demountably attachable to the
blade portion. The guide means may be integral to the blade
portion.
[0035] In a fourth aspect, the invention extends to an intubation
device (typically a laryngoscope) and a blade portion according to
the third aspect of the invention. The blade portion may be
demountably attached to the intubation device (for example, the
blade portion may be a disposable laryngoscope blade and the
intubation device may be a reusable laryngoscope (e.g. video
laryngoscope) body). The blade portion may be integral to the
intubation device.
[0036] The invention extends in a fifth aspect to a kit comprising
a guide means according to the first or second aspect of the
invention, or a blade portion according to the third aspect of the
invention, or an intubation device according to the fourth aspect
of the invention; an introducer having a diameter sufficiently
small to extend through the guide means (in the operating
configuration where applicable) and an intubation tube (for example
an endotracheal tube) having a diameter sufficiently large to not
extend through the guide means.
[0037] In a sixth aspect, the invention extends to a method of
intubating a patient, comprising the step of introducing an
intubation device according to the fourth aspect of the invention
into a patient, with an introducer extending through an intubation
tube and the guide means, and then advancing an intubation tube
towards the guide means such that the guide means causes the
introducer to be removed from the guide means. Typically, the
intubation device is then removed. The intubation device may be a
laryngoscope, the intubation tube may be an endotracheal tube and
the method may comprise the step of inserting the introducer into a
patient's trachea before the endotracheal tube is advanced such
that the guide means causes the introducer to be removed from the
guide means.
BRIEF DESCRIPTION OF THE DRAWINGS
[0038] Embodiments of the invention will now be described, by way
of example only, with reference to the accompanying drawings, in
which:
[0039] FIG. 1 is a perspective view of a laryngoscope blade
comprising an introducer guide attached to the side of the blade
according to an embodiment of the invention;
[0040] FIG. 2 is a schematic illustration of the introducer guide
according to an embodiment of the invention in use;
[0041] FIG. 3 is a perspective side view of an introducer guide
which can be removably attached to a blade portion of a suitable
medical device;
[0042] FIG. 4 is a rear perspective view of a preferred embodiment
of the introducer guide attached to a blade portion of a medical
device; and
[0043] FIGS. 5A and 5B is a cross section though an introducer
guide according to a further embodiment of the invention, in
flattened and operating configurations respectively.
[0044] Referring firstly to FIG. 1, the drawing shows a blade
portion 12 of a laryngoscope (being an example of an intubation
device), with an introducer guide (functioning as guide means) 19
attached thereto. The introducer guide 19 includes a continuous
channel, with an elongate longitudinal portion which is open to
facilitate the gentle release of an introducer or bougie (not
shown). The introducer guide 19 is resiliently deformable and in
the non-deformed position, in which no force is being exerted on
the channel, the open portion is slightly narrower than the outer
diameter of the bougie such that it holds the bougie in position.
The internal diameter of the channel is smaller than the outer
diameter of the intubation tube being used (not shown). The first
end 22 of the introducer guide 19 has a gentle taper, such that
when the leading edge of the intubation tube comes into contact
with the tapered first end 22 of the introducer guide 19, it
diverts the intubation tube away from the blade portion 12, and
gently eases the bougie from the introducer guide 19. In the
depicted embodiment, the introducer guide 19 is positioned
substantially near the point of curvature 24 of the blade portion
12, and is angled to guide a bougie 20 through the best approach
into the larynx.
[0045] A schematic depiction of the introducer guide in use is
illustrated in FIG. 2. Prior to use, the bougie 20 is clipped into
the introducer guide 19. In use, the blade portion (not shown) of a
laryngoscope (not shown), is inserted through the oral cavity into
the pharyngeal area, displacing the tongue and the epiglottis of
the patient. The bougie 20 is then gently eased forward within the
introducer guide 19 so that it is directed into position within the
trachea of the patient. Once the bougie 20 is in place (FIG. 2(i)),
the intubation tube 23 is guided along the bougie 20 within the
throat (FIG. 2(ii)) until it comes into contact with the shaped
first end 22 of the introducer guide 19 (FIG. 2(iii). The contact
between the leading edge of the intubation tube 21 and the tapered
first end 22 of the introducer guide 19 causes the intubation tube
21 to be directed upwards. This causes the intubation tube 21 to
contact the bougie 20, and to force the bougie upwards (FIG.
2(iv)). As the walls of the introducer guide 19 are slightly
deformable, the force of the bougie 20 being moved upwards causes
the introducer guide 19 to release the bougie 20.
[0046] Referring now to FIG. 3, the drawing depicts another
introducer guide 119 which can be removably attached to a blade
portion of a laryngoscope of other intubation device. The
introducer guide is generally depicted at 119 and forms a channel,
with a longitudinal portion which is open to allow the bougie (not
shown) to be released from the introducer guide 119 once in
position. The introducer guide 119 comprises a clip portion 25 to
allow it to be releasably attached to a surface of a blade portion
of a suitable medical device.
[0047] FIG. 4 depicts a introducer guide 219 which is attached to a
blade portion 12 of a laryngoscope. The introducer guide is
generally depicted at 219 and is the preferred embodiment. This
embodiment generally works in the same way as the embodiment of
FIG. 1 with the exception that when the introducer guide 219 is
attached, either permanently or releasably, to a blade portion 12
of a suitable medical device, it forms a channel with a surface of
the blade portion 12, suitable for receiving a bougie (not shown).
This embodiment has the advantage that it is relatively cheap and
easy to manufacture.
[0048] FIGS. 5A and 5B are cross-sections through introducer guide
220 having a flattened configuration (FIG. 5A) and an operating
configuration (FIG. 5B). The introducer guide comprises a first
wall 222 and a flap 224 which pivots about hinge 226 so that it has
a low profile in the flattened configuration but functions as a
second wall, opposing the first wall and defining an open channel,
in the operating configuration. The tube guide is disposed
laterally of a channel 228 which retains a video camera.
[0049] It can be seen that the current invention has a number of
benefits over the prior art and a number of possible uses. Although
the example above relates to a laryngoscope, it can be seen that
the concept can be extended to other medical and veterinary devices
and still stay within the scope of the present invention.
[0050] It will be appreciated by persons skilled in the art that
the above embodiment has been described by way of example only, and
not in any limiting sense, and that various alterations and
modifications are possible without departure from the scope of the
invention as defined by the appended claims.
* * * * *