U.S. patent application number 15/452225 was filed with the patent office on 2017-08-24 for device for evacuating and/or monitoring gas leaking from a patient during surgery or anesthetization.
The applicant listed for this patent is FINANCIAL CONSULTANTS LLC. Invention is credited to Kevin Gerard Shea, Owen Francis Shea, Peter James Wachtell.
Application Number | 20170239431 15/452225 |
Document ID | / |
Family ID | 49916557 |
Filed Date | 2017-08-24 |
United States Patent
Application |
20170239431 |
Kind Code |
A1 |
Wachtell; Peter James ; et
al. |
August 24, 2017 |
DEVICE FOR EVACUATING AND/OR MONITORING GAS LEAKING FROM A PATIENT
DURING SURGERY OR ANESTHETIZATION
Abstract
A system is described herein for evacuating gas as it is leaking
from a patient's airway. The system comprises a gas evacuation
flowpath configured for collecting a gas flow escaping from the
patient when inserted into the patient's airway. A vacuum source is
connected to the gas evacuation flowpath. Devices that may be
employed as part of the system and a method for evacuating gas from
a patient are also described.
Inventors: |
Wachtell; Peter James;
(Boise, ID) ; Shea; Kevin Gerard; (Boise, ID)
; Shea; Owen Francis; (San Luis Obispo, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
FINANCIAL CONSULTANTS LLC |
Boise |
ID |
US |
|
|
Family ID: |
49916557 |
Appl. No.: |
15/452225 |
Filed: |
March 7, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13940175 |
Jul 11, 2013 |
9622683 |
|
|
15452225 |
|
|
|
|
61670462 |
Jul 11, 2012 |
|
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61776209 |
Mar 11, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 16/0666 20130101;
A61B 5/082 20130101; A61M 16/0463 20130101; A61M 16/01 20130101;
A61M 2016/103 20130101; A61M 16/0434 20130101; A61B 5/4211
20130101; A61M 16/04 20130101; A61B 5/4839 20130101; A61M 16/009
20130101; A61M 16/0486 20140204; A61M 16/06 20130101; A61B 5/097
20130101; A61M 2016/1035 20130101; A61M 16/1005 20140204; A61M
2016/1025 20130101; A61M 16/0003 20140204; A61M 16/085 20140204;
A61M 16/021 20170801 |
International
Class: |
A61M 16/00 20060101
A61M016/00; A61M 16/01 20060101 A61M016/01; A61M 16/10 20060101
A61M016/10; A61B 5/00 20060101 A61B005/00; A61M 16/04 20060101
A61M016/04; A61M 16/06 20060101 A61M016/06 |
Claims
1.-30. (canceled)
31. A method for evacuating gas as it is leaking from a patient's
airway, the method comprising: collecting a gas that has leaked
past a seal of closed circuit gas administration equipment and into
the patient's throat or mouth; and removing the collected gas from
the patient using a vacuum system.
32. The method of claim 31, wherein the seal is a primary seal, the
method further comprising providing a secondary seal in the
patient's airway that is separate from the primary seal, the
collecting of the gas occurring between the primary seal and the
secondary seal.
33. The method of claim 32, further comprising administering a gas
to a patient using the airway tube, the patient airway tube
including the primary seal.
34. The method of claim 33, wherein the gas comprises
anesthesia.
35. The method of claim 33, further comprising determining one of
oxygen concentration, anesthesia concentration or CO.sub.2 gas
concentration in the collected gas.
36. The method of claim 31, further comprising determining one of
oxygen concentration, anesthesia concentration or CO.sub.2 gas
concentration in the collected gas.
37. The method of claim 36, further comprising determining the
effectiveness of the primary seal using the determined
concentration of the collected gas.
38. The method of claim 36, further comprising providing determined
oxygen concentration data to a user.
39. The method of claim 31, further comprising determining if there
is acid reflux in the patient's airway.
40. The method of claim 31, wherein the closed circuit gas
administration equipment comprises an intubation device comprising
an airway tube and the seal positioned on an outer perimeter of the
airway tube, the airway tube comprising a first flowpath configured
to administer a gas to the patient, the seal positioned in the
patient's airway to block a space between the airway tube and
tissue lining the patient's airway.
41. The method of claim 40, wherein the closed circuit gas
administration equipment further comprises a gas evacuation
flowpath comprising one or more vents positioned in the patient's
airway for collecting the gas that has leaked past the seal, the
gas evacuation flowpath being separate from the first flowpath.
42. The method of claim 41, wherein the seal is a primary seal, and
further comprising providing a secondary seal in the patient's
airway that is separate from the primary seal, the one or more
vents being positioned between the primary seal and the secondary
seal.
43. A method for evacuating gas as it is leaking from a patient's
airway, the method comprising: inserting an intubation device
comprising an airway tube and a primary seal positioned on an outer
perimeter of the airway tube, the airway tube comprising a first
flowpath configured to administer a gas to the patient, the primary
seal positioned in the patient's airway to block a space between
the airway tube and tissue lining the patient's airway; inserting a
gas evacuation flowpath comprising one or more vents into the
patient, and providing a secondary seal in the patient's airway
that is separate from the primary seal, the gas evacuation flowpath
being separate from the first flowpath and being inserted so that
the one or more vents are positioned in the patient's airway
between the primary seal and the secondary seal for collecting a
gas flow that leaks past the primary seal; collecting a gas that
has leaked past the primary seal and into the patient's throat or
mouth; and removing the collected gas from the patient using a
vacuum system.
44. The method of claim 43, wherein the intubation device is an
endotracheal tube.
45. The method of claim 43, wherein the intubation device is a
laryngeal mask airway.
Description
PRIORITY CLAIMS
[0001] This present application is a divisional of U.S. application
Ser. No. 13/940,175, filed Jul. 11, 2013, which claims priority
benefit to U.S. Provisional Application No. 61/670,462, filed Jul.
11, 2012; and U.S. Provisional Application No. 61/776,209, filed
Mar. 11, 2013 the disclosures of all of which are incorporated
herein by reference in their entirety.
FIELD OF THE DISCLOSURE
[0002] This invention relates generally to the field of medicine
and more specifically to a device for monitoring and evacuating gas
that leaks past a seal on an intubation device inserted into a
patient during surgery or a patient who is otherwise in need of
breathing support.
BACKGROUND
[0003] For patients undergoing surgery, or those that require
prolonged respiratory support, inhaled gases (oxygen, nitrogen),
and inhalation anesthetic agents are used routinely. These gases
are delivered via a closed system, with a goal to retain the
inhaled and exhaled gases within the closed system.
[0004] The general concept of scavenging anesthetic gases is well
known. In anesthetic gas systems that administrate highly toxic
gases such as halogenated ethers, it has been known for some time
that these substances are harmful. Gas systems have been designed
to minimize the exposure of the operating room personnel to these
gases. Closed breathing circuits are specifically designed to
create a closed system whereby the gas that is breathed in by the
patient is subsequently returned via a closed circuit back to the
gas administration system. These systems are generally focused on
recovering or reusing the anesthetic gases or at least scrubbing
them from the air before the air is vented.
[0005] One consistent area of leakage of these gases occurs at the
interface between the patient's airway and the device delivering
the gases. The interface is characterized by an incomplete seal
between the patient's tissues and the inserted endotracheal tube or
laryngeal mask airway ("LMA").
[0006] Leakage of these gases is not without risk, both in the
short term and long term. Short term leakage of oxygen is a direct
risk to patients, especially in settings where electrical current
and electric instruments are present. Oxygen is a fire accelerant,
and significant leakage in health care settings can lead to
catastrophic fires. These fires can burn the inside of the lungs,
as well as other portions of the patient's body. In addition to the
risks to the patient, the operating room and other hospital staff
are also at risk of burn/inhalation injury.
[0007] Long term risks of anesthetic gas leakage are also a concern
to hospital operating room and critical care unit staff. Recent
research has demonstrated increase concentrations of inhalation
anesthetics in operating room staff. The long term exposure risks
to these agents have not been clarified in the research literature,
but many of these agents have documented tissue toxicity, including
neuro-toxicity. Recent research has highlighted these concerns, and
raised questions about toxicity with chronic exposure, even at low
concentrations.
[0008] Current endotracheal tubes ("ETT") and laryngeal mask airway
("LMA") designs (including nasal trumpets for certain difficult
cases) often have features that partially address the issue of
surgical gas leakage. For example, ETT often use an inflatable cuff
to limit leakage from a patient's airway during surgery. While
these inflatable cuffs are partially effective, they often do not
fully seal, thus resulting in unwanted leakage of the surgical
gases from the patient. In addition, the inflation pressure for the
inflatable cuff around the airway can cause tissue damage to the
windpipe/trachea, if the pressure is inflated to high. Low pressure
in the inflatable cuff is less damaging to the windpipe, but it
allows for a less secure airway seal.
[0009] To provide an improved fit of the seal around the airway and
thereby limit leakage, both the ETT and LMA are available in
different sizes. However, even properly fitted seals can allow for
leakage of surgical gas from a patient's airway. Because of
significant anatomic variation seen in the airway and due to the
vascular nature of the tissue, obtaining a perfect seal in the
majority of cases can be difficult. For this reason, at least small
amounts of gas leakage is common.
[0010] As mentioned above, a patient's body does not always create
a perfect match to a closed breathing circuit and as a result, gas
may leak from the breathing circuit from time to time or in some
cases continuously. It would be a step forward in the art to
provide a means for capturing these gases when and if they leak
from a closed breathing circuit within a patient's throat or
nares.
SUMMARY
[0011] The present disclosure is directed to various embodiments,
among which include the following directed to a system for
evacuating gas as it is leaking from a patient's airway: [0012]
1.01 A system for evacuating gas as it is leaking from a patient's
airway, the system comprising: a gas evacuation flowpath configured
for collecting a gas flow escaping from the patient when inserted
into the patient's airway; and a vacuum source connected to the gas
evacuation flowpath. [0013] 1.02 The system of claim 1.01, further
comprising at least one sensor for determining a concentration of a
measured gas in the gas flow. [0014] 1.03 The system of claim 1.02,
wherein the at least one sensor is fluidly connected to the gas
evacuation flowpath, the at least one sensor being capable of real
time, continuous monitoring of a gas in the gas flow that is
collected from the patient. [0015] 1.04 The system of claim 1.03,
further comprising: a gas monitoring device in communication with
the at least one sensor, the gas monitoring device including a
component chosen from a data logger, alarm system or monitoring
screen; a vacuum pressure valve capable of providing a vacuum to
the gas evacuation plug when it is placed inside the patient's
airway; and a connection from the vacuum pressure valve to the
vacuum source. [0016] 1.05 The system of claim 1.02, wherein the at
least one sensor is configured to monitor at least one of oxygen
concentration, anesthesia concentration, CO2 concentration or pH.
[0017] 1.06 The system of claim 1.01, wherein the gas evacuation
flowpath comprises a gas evacuation plug attached to a patient
airway tube, the plug being configured to expand to fill the
patient's mouth cavity to provide a seal. [0018] 1.07 The system of
claim 1.01, further comprising a second flowpath configured to
administer a gas to a patient. [0019] 1.08 The system of claim
1.07, wherein the second flowpath and the gas evacuation flowpath
are both integrated into a multi-lumen endotracheal tube, the
multi-lumen endotracheal tube comprising a first lumen and one or
more smaller lumens, the first lumen being the second flowpath
configured to deliver anesthetic gases into and out of the lungs of
a patient; and the one or more smaller lumens being the gas
evacuation flowpath dedicated to providing vacuum pressure to
evacuate gasses that have leaked past the seal. [0020] 1.09 The
system of claim 1.01, wherein the gas evacuation flowpath comprises
a Guedel airway modified to evacuate gas as it is leaking from a
patient's throat during surgery, the Guedel airway comprising: a
conduit providing an airway; a flange positioned at an end of the
conduit; and a plurality of vents positioned in the conduit, the
vents configured to allow gas in a patient's throat to move into
the modified Guedel airway. [0021] 1.10 The system of claim 1.01,
wherein the gas evacuation flowpath comprises a first tube
configured to be placed through a patient's mouth or nares; and a
device positioned at or near the end of the first tube, the device
chosen from a cap or a spacer. [0022] 1.11 The system of claim
1.01, wherein the gas evacuation flowpath comprises a nasal
trumpet, the nasal trumpet comprising: a conduit providing an
airway; a flange positioned at an end of the conduit; and a
plurality of vents positioned in the conduit, the vents configured
to allow gas in a patient's airway to move into the conduit.
[0023] Other embodiments of the present disclosure are directed to
a sleeve for use with an intubation device comprising a seal,
including the following: [0024] 2.01 A sleeve for use with an
intubation device comprising a seal, the sleeve comprising: a plug
configured to fit above the seal in a patient's airway; a flowpath
running through the plug for evacuating surgical gases; and one or
more vent positioned in the plug, the vents configured so that when
a vacuum is applied to the conduit, evacuation of leaking surgical
gas from the patient's airway occurs through the conduit. [0025]
2.02 The sleeve of claim 2.01, wherein the plug is configured to
expand to fill the patient's mouth cavity to provide a secondary
seal. [0026] 2.03 The sleeve of claim 2.01, wherein the plug
comprises foam. [0027] 2.04 The sleeve of claim 2.01, wherein the
plug comprises open cell foam. [0028] 2.05 The sleeve of claim
2.01, wherein the flowpath comprises a connection for attaching to
vacuum tubing.
[0029] Still other embodiments are directed to a device for
collecting gas from a patient, including the following: [0030] 3.01
A device for collecting gas from a patient, the device comprising:
a conduit comprising a first opening, a second opening and a
flowpath between the first and second openings, the conduit
configured to be inserted into the airway of a patient; a flange
positioned proximate the first opening of the conduit; a plurality
of vents positioned in the conduit, the vents configured to allow
gas in a patient's airway to move into the flowpath. [0031] 3.02
The device of claim 3.01, further comprising: a seal positioned
around the conduit, the seal configured to block a space between
the conduit and tissue lining a patient airway; a first lumen
configured to deliver anesthetic gases into and out of the lungs of
a patient; wherein the flowpath comprises one or more smaller
lumens dedicated to providing vacuum pressure to evacuate gasses
that have leaked past the seal, the one or more smaller lumens
configured concentrically around the first lumen; and wherein the
second opening is the plurality of vents in fluid connection with
the one or more smaller lumens, the vents configured to collect
gases that leak past the seal. [0032] 3.03 The endotracheal tube of
claim 3.02, further comprising a plug positioned on the multi-lumen
endotracheal tube, the vents being positioned between the seal and
the plug. [0033] 3.04 The device of claim 3.01, wherein the device
is configured as a Guedel airway for insertion into a patient's
throat. [0034] 3.05 The device of claim 3.04, wherein the flange
comprises notches that are configured to accommodate a device
selected from an endotracheal tube or LMA. [0035] 3.06 The device
of claim 3.04, further comprising an adapter that fits onto the
Guedel airway and allows a user to attach an operating room vacuum
source to the airway. [0036] 3.07 The device of claim 3.01, wherein
the device is configured as a nasal trumpet for insertion into a
nare of the patient.
[0037] Yet other embodiments of the present disclosure are directed
to methods for evacuating gas as it is leaking form a patient's
airway, including the following: [0038] 4.01 A method for
evacuating gas as it is leaking from a patient's airway, the method
comprising: collecting a gas that has leaked past a seal of closed
circuit gas administration equipment and into the patient's throat
or mouth; and removing the collected gas from the patient using a
vacuum system. [0039] 4.02 The method of claim 4.01, further
comprising determining one of oxygen concentration, anesthesia
concentration or CO2 gas concentration in the collected gas. [0040]
4.03 The method of claim 4.02, further comprising administering a
gas to a patient using a patient airway tube, the patient airway
tube including the seal. [0041] 4.04 The method of claim 4.03,
wherein the gas comprises anesthesia. [0042] 4.05 The method of
claim 4.03, further comprising determining the effectiveness of the
seal using the determined concentration of the collected gas.
[0043] 4.06 The method of claim 4.02, further comprising providing
determined oxygen concentration data to a user. [0044] 4.07 The
method of claim 4.02, further comprising determining if there is
acid reflux in the patient's airway.
[0045] It is to be understood that both the foregoing general
description and the following detailed description are exemplary
and explanatory only and are not restrictive of the present
teachings, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
[0046] The accompanying drawings, which are incorporated in and
constitute a part of this specification, illustrate embodiments of
the present teachings and together with the description, serve to
explain the principles of the present teachings.
[0047] FIG. 1 is a perspective view of a cuffed patient airway tube
fitted with a foam evacuation plug inserted into a patient's
throat, according to an embodiment of the present disclosure.
[0048] FIG. 2 is an exploded view showing a patient airway tube
with a cuff that is commonly used in operating rooms today; and a
gas evacuation plug configured to attach to the airway tube, with a
vacuum tube affixed thereto, according to an embodiment of the
present disclosure.
[0049] FIG. 3 is a schematic view depicting one potential circuit
layout of the device of FIG. 1, in conjunction with oxygen sensors
and a gas monitoring device for use in an operating room
environment, according to an embodiment of the present
disclosure.
[0050] FIG. 4 illustrates a multi-lumen device, according to an
embodiment of the present disclosure.
[0051] FIG. 5 is a perspective view of a separate tube that can be
placed in a patient's airway in addition to and/or adjacent to an
intubation device for providing surgical gas to a patient, such as
an endotracheal tube, a laryngeal mask airway tube, or a nasal
device, according to an embodiment of the present disclosure.
[0052] FIGS. 6 and 7 illustrate Guedel airways that can be employed
as a gas evacuation device, according to an embodiment of the
present disclosure.
[0053] FIG. 8 is a diagram of a standard Guedel Airway.
[0054] FIG. 9 illustrates a nasal trumpet device configured to
collect gas from a patient, according to an embodiment of the
present disclosure.
[0055] It should be noted that some details of the figure have been
simplified and are drawn to facilitate understanding of the
embodiments rather than to maintain strict structural accuracy,
detail, and scale.
DESCRIPTION OF THE EMBODIMENTS
[0056] Reference will now be made in detail to embodiments of the
present teachings, examples of which are illustrated in the
accompanying drawings. In the drawings, like reference numerals
have been used throughout to designate identical elements. In the
following description, reference is made to the accompanying
drawing that forms a part thereof, and in which is shown by way of
illustration a specific exemplary embodiment in which the present
teachings may be practiced. The following description is,
therefore, merely exemplary.
[0057] An embodiment of the present disclosure is directed to a
system for safely capturing surgical gases that have leaked past a
seal that is engineered into a patient airway tube, such as an
endotracheal tube, laryngeal airway mask, nasal trumpet or nasal
tube, or other similar device; and to remove these gases from the
patient without allowing them to disperse into the operating room.
Oxygen/gas removal can significantly lower the risk for surgical
fire and patient burns (e.g., burns in the lungs, airway/mouth,
face, neck or shoulders). As an example, the seal can be formed
using an inflated cuff, as is well known in the art.
[0058] In addition, the system can optionally include the ability
to measure the amount of gas leakage that is occurring in real time
and to show the operating room staff the current status of the tube
seal at any given time. For example, the oxygen that is evacuated
by the device may be monitored. Because the concentration ratio of
oxygen to anesthetic gases in the leaking surgical gas is a known
parameter, the system can use the monitored oxygen to calculate the
total amount of leaking surgical gases and thereby provide feedback
to the anesthesiologist about the relative volume of any leaks. In
a similar manner, the exhaled anesthetic gas concentrations could
also be measured to provide an indication of the magnitude of gas
leakage while the patient is under anesthesia. One of ordinary
skill in the art would readily be able to determine the magnitude
of gas leakage given the exhaled anesthetic gas concentrations.
Based on this data, the appropriate protocols to prioritize the
patient's and the operating room staff's safety can be
determined.
[0059] FIG. 1 illustrates a vented sleeve 100, according to an
embodiment of the present disclosure. Sleeve 100 is configured to
slip over an existing intubation device 102, which can be an
endotracheal tube or laryngeal airway mask. Sleeve 100 fits above a
seal 104 of the existing device in the patient's throat or mouth.
One or more vents 106 are configured so that when a slight vacuum
is applied to the operator end of the sleeve, evacuation of leaking
surgical gas from the patient's throat or mouth through the
attached conduit 108 results. FIG. 2 provides an exploded view
showing patient airway tube 102 with a cuff, or seal 104, which is
commonly used in operating rooms today. A sleeve 100 is shown
configured to attach to the patient airway tube. A vacuum tube 108
is affixed thereto, according to an embodiment of the present
disclosure.
[0060] In an embodiment, the sleeve 100 can comprise an expandable
plug 110. Expandable plug 110 can comprise any suitable material.
In one embodiment, the material is foam, such as an open cell foam,
which is capable of expanding to fill the patient's mouth cavity to
provide a secondary seal. Alternatively, plug 110 can comprise any
other suitable material that can provide the desired secondary
seal. In an embodiment, a flow path for evacuating the surgical
gases can extend through the plug 110. Conduit 108 can attach to
and/or extend through plug 110 as part of the flowpath. Conduit 108
can comprise any suitable material and can be, for example, vacuum
tubing.
[0061] FIG. 3 illustrates a system 120 for monitoring gases in an
operating room environment, according to an embodiment of the
present disclosure. The system 120 comprises a patient airway tube
102 having a seal 104. A sleeve 100 is attached to tube 102. In an
embodiment, the tube 102 and sleeve 100 can be those described
above in connection with FIGS. 1 and 2.
[0062] One or more sensors 122 are fluidly connected to the sleeve
100. The one or more sensors are capable of real time, continuous
monitoring of a gas that is drawn from a patient using the sleeve
100. In an embodiment, the gas being sensed can be chosen from
oxygen gas, CO.sub.2 or anesthesia. Gas sensors 122 can also be
used to determine pH of the gas evacuated from the patient.
[0063] The sensed gas levels coming from the patient can be
compared to, for example, ambient levels of gases, such as CO.sub.2
or oxygen, in the operating room. For example, sensors 122 can be
kept in a container that is separate from the ambient operating
room atmosphere. Gas that is drawn from the patient can be compared
to the ambient levels of oxygen in the operating room. If sensors
122 indicate higher oxygen concentrations in the gas drawn from the
patient relative to the ambient levels, this would be indicative to
the operator that a leak of surgical gases is occurring.
Alternatively, in an embodiment employing a sensor that measures
anesthetic gases directly, the sensor can provide a direct
indication of any gas leakage without the need for comparison with
ambient oxygen levels.
[0064] A gas monitoring device 124 can be in communication with the
one or more sensors 122. Gas monitoring device 124 can include a
component chosen from, for example, a data logger, alarm system or
monitoring screen.
[0065] A vacuum pressure valve 126 is employed to provide a steady
and suitably low level of vacuum pressure to the gas evacuation
plug while it is placed inside the patient's throat or oral cavity.
Vacuum pressure valve 126 can be connected to the operating rooms
vacuum evacuation facility at, for example, point "A".
[0066] As discussed above, the ability to provide a slight vacuum
sufficient to evacuate a leaking surgical gas above a primary seal
can allow the system to flow the leaking gas past an oxygen sensor,
such as, for example, a sensor that is placed along the evacuation
line itself. Because surgical gases comprise at least some oxygen,
the system can be used to determine when the surgical gases are
being leaked from the patient. For example, by measuring the
concentration of oxygen in the gas and correlating it to the level
of oxygen that is being used for that patient, the operator can
monitor the relative amount of gas that is leaking from the patient
at any given time. In an embodiment, this data can be provided to
the operator in the form of a screen charting the trend line of the
oxygen concentration of the gas that is being evacuated relative to
the oxygen concentration in the operating room itself. In a similar
manner, monitoring the concentrations of leaked anesthetic gases
can also be used to determine the magnitude of the gas leak.
[0067] Charting this trend line can aid in several different
aspects of the operating room's case management. Large volumes of
enriched oxygen leaking into the operating room can be hazardous
with regard to creating a fire hazard or an environment where flash
fires can occur. This is both dangerous for patients and for
operating room personnel. Being informed of leaking oxygen can
serve to allow the anesthesiologist to limit the amount of gas
escaping into the operating room and/or to take steps to prevent
the buildup of such gases to dangerous levels.
[0068] As part of this process, the identification of a leak around
the cuff of an endotracheal tube or other such device allows the
operator to slightly increase the pressure on the inflatable cuff
such that the minimum amount of inflation can be used to create an
effective seal. This is an improvement over current practice, in
that too much cuff inflation can cause harm to the patient's vocal
cords and airway tissue, and discomfort to the patient. By
determining the amount of pressure that can be employed to maintain
an effective seal, an operator using this system would be able to
accurately and continuously monitor the amount of pressure that is
being used to inflate the cuff to insure the minimal level of
patient discomfort or harm.
[0069] The system can also include the ability to notify the
operating room personnel about anesthesia gas leakage by detecting
the presence of increased concentration of CO.sub.2 from the gas
that leaks. Ambient levels of CO.sub.2 gas are approximately 0.03%
while CO.sub.2 in exhaled breath is approximately 4%. Due to the
higher relative concentration of CO.sub.2 in exhaled breath,
monitoring of the CO.sub.2 gas concentration in the evacuated gas
stream coming from the patient can inform the anesthesiologist if
exhaled breath is leaking from around the seal on the patient
airway tube. The monitoring of CO.sub.2 can indicate a leak even
when enriched oxygen is not being used during the surgery.
[0070] In addition to monitoring gas concentrations, the devices of
the present disclosure can optionally include the ability to
measure the pH level and/or to determine if acid is refluxing from
the stomach into the airway region. The pH level or change thereof
can be used to warn the surgical team of potential danger to the
patient's airway. Sensing the pH can be performed in any desired
manner. In an embodiment, gases collected from the patient can be
analyzed to determine pH or changes in pH, which may be used to
indicate reflux in the patient's airway. Devices for sensing pH
levels of a gas flow are well known in the art. In another
embodiment, the devices of the present disclosure can include a
small probe (not shown) that sits near the airway. Any suitable pH
probe can be employed. Suitable pH probes are well known and one of
ordinary skill would readily be able to employ such probes, such as
by positioning a pH probe on any of the airway devices of the
present disclosure. If fluid comprising acidic contents from the
patient's stomach comes into the region near the airway, the probe
can identify a drop in pH. Regardless of the technique used to
detect pH, the change in pH can be communicated to the operating
team to make them aware of a potentially dangerous environment for
the patient's airway. If these conditions are identified, an
anesthesiologist can act appropriately, such as by removing the
potentially harmful fluid from near the airway and/or by modifying
the anesthesia technique appropriately to protect the patient.
[0071] FIG. 4 illustrates an intubation device comprising a fully
integrated flowpath for evacuating leaking gases, according to an
embodiment of the present disclosure. For example, the intubation
device can be in the form of an endotracheal tube comprising a
multi-lumen conduit. As illustrated in FIG. 4, an endotracheal tube
can include a large lumen 140 that serves to deliver anesthetic
gases into and out of the lungs of the patients, while one or more
smaller lumens 142 are dedicated to providing vacuum pressure to
evacuate any gasses that have leaked above the tube seal 104. Vents
144 provide fluid communication between the patient's airway above
the seal 104 and the small lumen 142, thereby allowing leaking gas
to flow into the small lumen 142 and out of the patient. Vacuum
pressure can be provided by any suitable means, such as through
conduit 108 attached to a port 146 in the multi-lumen conduit. The
multi-lumen conduit can be made of any suitable material, such as,
for example, PVC. The smaller lumen 142 can be in the form of a
concentric annulus or any other suitable conduit configuration.
[0072] In an alternative embodiment, it may be possible to evacuate
leaking gases without a secondary seal device. For example, in the
embodiment of FIG. 4, sleeve 100 may be eliminated. Leaking gases
can be collected by simply providing a sufficient vacuum through
the one or more vents 144.
[0073] FIG. 5 illustrates a tubular device 150 that can be placed
either through the patient's mouth or nares separately or together
with an existing device 102 for providing surgical gases to a
patient, according to an embodiment of the present disclosure. The
tubular device 150 can include a cap or spacer positioned at or
near the end of a tube. For example, the end of the tube can be
fitted with a foam evacuation plug 152. The foam plug 152 can
reduce the likelihood of developing an area of higher pressure
suction that might damage the mucosal tissue. The tubular device
can be placed in the patient's airway in addition to and/or
adjacent to, for example, an endotracheal tube, a laryngeal mask
airway tube, or a nasal airway tube.
[0074] The tubular device 150 allows for evacuating and/or
monitoring surgical gases, such as oxygen and anesthetic gases that
have leaked past a seal on an endotracheal tube, laryngeal mask
airway tube, nasal device or other device for delivering oxygen and
other gases to patients. A means can be employed for applying a
vacuum to the tubular device 150 such that any oxygen or
accompanying anesthetic gases that leak from around the seal are
drawn from the patient and evacuated from the operating room,
similarly as described for sleeve 100 and the system of FIG. 3. In
an embodiment, tubular device 150 can replace sleeve 100 in the
system of FIG. 3.
[0075] FIGS. 6 and 7 illustrate a Guedel airway design that can be
used to evacuate or scavenge gas as it is leaking from a patient's
throat. Geudel airways are generally well known in the art. A
conventional Geudel airway is shown in FIG. 8. However, the Guedel
airway 200, as shown in FIGS. 6 and 7, has been modified so that it
can functionally replace the device of FIG. 1 in the system of FIG.
3. In an embodiment, the Guedel airway designs do not include a
sleeve 100.
[0076] Guedel airway 200 includes vents 202 in the airway. Vents
202 are configured to allow gas in the patient's throat to move
into the modified Guedel airway. Employing a plurality of vents 202
can provide redundant access to the airway from the patient's
throat area in order to decrease the likelihood that tissue can be
sucked up against a single vent opening when suction is applied to
the airway and thereby clog the airway. If only a single opening
204 exists (as in the conventional airway of FIG. 8) the opening
204 can potentially be suctioned up against soft tissue in a
patient's throat area and become occluded.
[0077] A flange 206 is positioned at an end of the Geudel airway.
Flange 206 can be designed with notches 208 that can accommodate an
endotracheal tube or LMA on either side of the Geudel airway. This
can allow Geudel airway 200 to more easily sit directly adjacent to
an endotracheal tube or LMA tube when the Geudel airway end
opposite flange 206 is inserted into a patient's mouth and throat
during surgery. The purpose of Geudel airway 200 is to remove gas
that has leaked from, for example, an endotracheal tube or LMA seal
that is also positioned in a patient's throat. The Geudel airway
200 can be attached to any suitable vacuum source to provide the
desired suction. FIG. 7 illustrates an example of an adapter 210,
which fits onto the Guedel airway and allows a user to easily
attach an operating room vacuum source to the airway using a
standard suction tube, such as conduit 108 in FIG. 1. For example,
the adapter end 212 can be designed to be inserted into hole 204 at
the flanged end of the Guedel airway to form an air-tight seal.
Adaptor end 214 can be attached to the vacuum source. As oxygen
and/or anesthetic are administered to the patient through the
endotracheal tube or LMA, the vacuum source can suction any leaking
gases through the vents 202 and hole 204 and into the Geudel airway
200. In an embodiment, the Guedel airway 200 can be used in place
of the vented sleeve 100 in the system of FIG. 1.
[0078] Other embodiments may exist that serve to provide this same
functionality and these same concepts may be applied to other
devices that are used to assist patients in need of breathing
assistance, such as nasal trumpets. For example, FIG. 9 illustrates
a nasal trumpet 250 comprising holes 204, 214 for the main air
flow, as well as vents 202, similar to the Geudel airway design,
according to an embodiment of the present disclosure. If desired,
the vents 202 can be placed in multiple positions along the nasal
trumpet to increase the amount of captured gases from the patient
and/or to reduce the chance of air flow blockage through the
device. An adapter, such as adapter 210 of FIG. 7, can be used to
provide a connection between the hole 204 of nasal trumpet 250 and
the vacuum source. In an embodiment, the nasal trumpet 250 can be
used in place of or in addition to the vented sleeve 100 in the
system of FIG. 1. The nasal trumpet 250 is placed through the
patient's nares, in addition to, or instead of using the
traditional mouth area for access. If desired, a pH detection
system as desired herein above can be used in combination with any
of the airway devices of the present disclosure, including the
nasal trumpet 250, Guedel airway 200, sleeve 100, nasal tube 150 or
endotracheal tube devices of FIG. 1 or 4.
[0079] Notwithstanding that the numerical ranges and parameters
setting forth the broad scope of the disclosure are approximations,
the numerical values set forth in the specific examples are
reported as precisely as possible. Any numerical value, however,
inherently contains certain errors necessarily resulting from the
standard deviation found in their respective testing measurements.
Moreover, all ranges disclosed herein are to be understood to
encompass any and all sub-ranges subsumed therein.
[0080] While the present teachings have been illustrated with
respect to one or more implementations, alterations and/or
modifications can be made to the illustrated examples without
departing from the spirit and scope of the appended claims. In
addition, while a particular feature of the present teachings may
have been disclosed with respect to only one of several
implementations, such feature may be combined with one or more
other features of the other implementations as may be desired and
advantageous for any given or particular function. Furthermore, to
the extent that the terms "including," "includes," "having," "has,"
"with," or variants thereof are used in either the detailed
description and the claims, such terms are intended to be inclusive
in a manner similar to the term "comprising." Further, in the
discussion and claims herein, the term "about" indicates that the
value listed may be somewhat altered, as long as the alteration
does not result in nonconformance of the process or structure to
the illustrated embodiment. Finally, "exemplary" indicates the
description is used as an example, rather than implying that it is
an ideal.
[0081] It will be appreciated that variants of the above-disclosed
and other features and functions, or alternatives thereof, may be
combined into many other different systems or applications. Various
presently unforeseen or unanticipated alternatives, modifications,
variations, or improvements therein may be subsequently made by
those skilled in the art which are also intended to be encompasses
by the following claims.
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