U.S. patent application number 14/304264 was filed with the patent office on 2014-10-02 for medical device tube having a suction lumen and an associated suctioning system.
The applicant listed for this patent is COVIDIEN LP. Invention is credited to Brian Ledwith, Seamus Pio Maguire, Lockett E. Wood.
Application Number | 20140290649 14/304264 |
Document ID | / |
Family ID | 44513130 |
Filed Date | 2014-10-02 |
United States Patent
Application |
20140290649 |
Kind Code |
A1 |
Maguire; Seamus Pio ; et
al. |
October 2, 2014 |
MEDICAL DEVICE TUBE HAVING A SUCTION LUMEN AND AN ASSOCIATED
SUCTIONING SYSTEM
Abstract
Various embodiments of a tracheal tube having a suction lumen
are provided. For example, the suction lumen may be associated with
two spaced apart pressure transducers, whereby a pressure drop
between the transducers indicates that the suction lumen is free of
blockages and a characteristic lack of pressure drop and/or
particular pressure curve is indicative of a blockage. In addition,
embodiments may include a tracheal tube with sensors configured to
sense a buildup of secretions. The sensors may be located proximate
to an opening in the suction lumen. In other embodiments, a
blockage-clearing system for a suction lumen may be provided that
blows air into the suction lumen to clear blockages. In particular,
in certain embodiments, the blockage-clearing system may operate to
create its own pressurized air source by utilizing the pressure
change created in the suction line by a blockage.
Inventors: |
Maguire; Seamus Pio;
(Athlone, IE) ; Wood; Lockett E.; (Lyons, CO)
; Ledwith; Brian; (Co. Longford, IE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
COVIDIEN LP |
Mansfield |
MA |
US |
|
|
Family ID: |
44513130 |
Appl. No.: |
14/304264 |
Filed: |
June 13, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12847795 |
Jul 30, 2010 |
8783255 |
|
|
14304264 |
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Current U.S.
Class: |
128/202.16 |
Current CPC
Class: |
A61M 2205/70 20130101;
A61M 2205/18 20130101; A61M 16/0443 20140204; A61M 16/0463
20130101; A61M 2205/6072 20130101; A61M 16/0486 20140204; A61M
2016/0027 20130101; A61M 2205/3331 20130101; A61M 2205/3317
20130101; A61M 16/0434 20130101; A61M 16/0479 20140204; A61M
16/0858 20140204; A61M 2205/581 20130101; A61M 2205/3337 20130101;
A61M 16/04 20130101; A61M 2205/583 20130101; A61M 2209/06 20130101;
A61M 2205/3368 20130101; A61M 2205/6054 20130101; A61M 2205/502
20130101; A61M 16/0003 20140204 |
Class at
Publication: |
128/202.16 |
International
Class: |
A61M 16/04 20060101
A61M016/04; A61M 16/00 20060101 A61M016/00 |
Claims
1. A system, comprising: a tracheal tube configured to be inserted
into a patient's airway, wherein the tracheal tube comprises: a
conduit having a proximal end and a distal end; an inflatable cuff
surrounding the conduit, wherein the inflatable cuff is configured
to seal the airway; a first suction lumen formed in a wall of the
conduit and terminating in a first opening proximal to the
inflatable cuff; a first sensor disposed on the wall of the conduit
between the inflatable cuff and the opening, wherein the first
sensor is adjacent to the opening and configured to detect
secretion build-up above the inflatable cuff; a second sensor
disposed on the wall of the conduit adjacent to the inflatable cuff
and opposite the first sensor and the opening; and a monitor
communicatively coupled to the tracheal tube and comprising a
processor configured to receive information from the first sensor
and the second sensor, wherein the processor controls a vacuum
system configured to suction the secretions based on the
information.
2. The system of claim 1, wherein the first sensor at least
partially surrounds the opening.
3. The system of claim 1, wherein the first sensor is configured to
detect a percentage of the first opening covered by the secretion
build-up.
4. The system of claim 1, wherein the second sensor is configured
to detect secretion leakage around the inflatable cuff.
5. The system of claim 1, comprising a second suction lumen formed
in the wall of the conduit and terminating in a second opening
proximal to the inflatable cuff.
6. The system of claim 5, wherein the second opening is co-axially
aligned with the first opening.
7. The system of claim 5, wherein the second opening is associated
with the second sensor.
8. The system of claim 5, wherein the second suction lumen removes
the secretions when the first suction lumen is blocked with the
secretion build-up.
9. The system of claim 1, wherein the second sensor is positioned
on a ventral side when the tracheal tube is inserted into the
patient's airway.
10. The system of claim 1, wherein the first sensor is positioned
on a dorsal side when the tracheal tube is inserted into the
patient's airway.
11. A method, comprising: determining a first pressure associated
with a suction lumen formed in a wall of a tracheal tube configured
to be inserted into a patient's airway, wherein the suction lumen
is in fluid communication with a first pressure sensor configured
to measure the first pressure; measuring a second pressure
associated with the suction lumen with a second pressure sensor
spaced apart from the first sensor; determining a pressure
differential between the first pressure and the second pressure,
wherein the pressure differential is indicative of secretion
blockage in the suction lumen; detecting a characteristic pressure
drop between the first and second pressure sensors; and applying a
vacuum to the suction lumen based on the pressure differential and
the characteristic pressure drop.
12. The method of claim 11, comprising removing the vacuum from the
suction lumen when the characteristic pressure drop is
detected.
13. The method of claim 12, wherein the suction lumen is blocked
when the first pressure and the second pressure are the same.
14. The method of claim 11, wherein the suction lumen is clear when
the pressure differential is equal to the characteristic pressure
drop.
15. The method of claim 11, comprising positioning the first
pressure sensor and the second pressure sensor on a suction tube
fluidly coupled to the suction lumen, wherein the suction tube is
exterior to the patient when the tracheal tube is inserted.
16. The method of claim 11, displaying information associated with
secretion blockage in the suction lumen on a monitor
communicatively coupled to the tracheal tube.
17. A system, comprising: A monitor coupled to a tracheal tube
inserted in a patient's airway and comprising: a processor
configured to receive a first signal from a first pressure sensor
and a second signal from a second pressure sensor fluidly coupled
to a suction lumen formed in a wall of the tracheal tube, wherein
the first and second signals are indicative of a pressure within
the suction lumen, and wherein the processor comprises instructions
configured to: determine a pressure differential between the first
and second signals, wherein the pressure differential is indicative
of secretion blockage in the suction lumen; compare the pressure
differential with a characteristic pressure drop associated with an
unblocked suction lumen; control a vacuum source configured to
remove the secretions through the suction lumen based on the
pressure differential and the characteristic pressure drop.
18. The system of claim 1, wherein the suction lumen is clear when
the pressure differential is equal to the characteristic pressure
drop.
19. The system of claim 1, wherein the first pressure sensor and
the second pressure sensor are external to the patient with the
tracheal is inserted.
20. The system of claim 1, wherein the monitor provides a
graphical, visual, or audio representation of the secretion
blockage in the suction lumen.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 12/847,795 filed Jul. 30, 2010, the contents of which are
hereby incorporated by reference in their entirety.
BACKGROUND
[0002] The present disclosure relates to tracheal tubes used in
medical applications and, more particularly, to tracheal tubes
having suctions lumens for suctioning secretions above a sealing
cuff and systems for controlling the suctioning.
[0003] This section is intended to introduce the reader to various
aspects of art that may be related to various aspects of the
present disclosure, which are described and/or claimed below. This
discussion is believed to be helpful in providing the reader with
background information to facilitate a better understanding of the
various aspects of the present disclosure. Accordingly, it should
be understood that these statements are to be read in this light,
and not as admissions of prior art.
[0004] In the course of treating a patient, a tube or other medical
device may be used to control the flow of air, food, fluids, or
other substances into and out of the patient. For example, medical
devices, such as tracheal tubes, may be used to control the flow of
air or other gases through a trachea of a patient. Such tracheal
tubes may include endotracheal tubes (ETTs), tracheostomy tubes, or
transtracheal tubes. In many instances, it is desirable to provide
a seal between the outside of the tube or device and the interior
of the passage in which the tube or device is inserted, such as the
trachea. In this way, substances can only flow through the passage
via the tube or other medical device inserted in the tube, allowing
a medical practitioner to maintain control over the type and amount
of substances flowing into and out of the patient. In addition, a
high-quality seal against the tracheal passageway allows a
ventilator to perform efficiently.
[0005] Such tracheal tubes are often coupled to an air source, such
as a ventilator, to provide the patient with a source of fresh air
that is transferred through a main ventilation lumen adapted to
allow airflow to and from the patient during inspiration and
expiration, respectively. However, it may be desirable for
additional functionalities to be provided by the tracheal tube. For
example, a tracheal tube may include a suction lumen that runs the
length of the tube and that terminates at an aperture located above
the inflatable cuff The suction lumen may be used for suctioning
patient secretions from the mouth and upper airway that flow down
into the trachea and accumulate above the inflatable cuff or on the
tube. Although the evacuation process may provide for removal of
secretions, it may be possible for the aperture to be come
occluded, in particular because patient secretions may be
relatively viscous and the aperture is small.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] Advantages of the disclosed techniques may become apparent
upon reading the following detailed description and upon reference
to the drawings in which:
[0007] FIG. 1 is a perspective view of an exemplary tracheal
ventilation system with a suction lumen coupled to two pressure
transducers;
[0008] FIG. 2A is a graph of the pressure over time for a first
pressure transducer of FIG. 1 during intermittent suctioning;
[0009] FIG. 2B is a graph of the pressure over time for a second
pressure transducers of FIG. 1 during intermittent suctioning;
[0010] FIG. 2C is a graph of the pressure over time for a
differential between the two pressure transducers of FIG. 1 during
intermittent suctioning;
[0011] FIG. 3 is a flow diagram of a method of controlling
suctioning that may be used in conjunction with the system of FIG.
1;
[0012] FIG. 4 is an elevation view of an exemplary tracheal tube
with a secretion sensor;
[0013] FIG. 5 is a side view of an exemplary tracheal tube with a
secretion sensor inserted into a patient trachea;
[0014] FIG. 6 is a side view of an alternative arrangement of a
tracheal tube with a circumferential secretion sensor;
[0015] FIG. 7 is a side view of an alternative arrangement of a
tracheal tube with a secretion sensor associated with an alternate
suction lumen;
[0016] FIG. 8 is a diagramatic view of an exemplary tracheal
suctioning system; and
[0017] FIG. 9A is a cross-sectional view of an exemplary tracheal
suctioning system that used the suction line to pressurize air;
and
[0018] FIG. 9B is a cross-sectional view of the tracheal suctioning
system of FIG. 9A in which the air is released into the suction
line.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0019] One or more specific embodiments of the present techniques
will be described below. In an effort to provide a concise
description of these embodiments, not all features of an actual
implementation are described in the specification. It should be
appreciated that in the development of any such actual
implementation, as in any engineering or design project, numerous
implementation-specific decisions must be made to achieve the
developers' specific goals, such as compliance with system-related
and business-related constraints, which may vary from one
implementation to another. Moreover, it should be appreciated that
such a development effort might be complex and time consuming, but
would nevertheless be a routine undertaking of design, fabrication,
and manufacture for those of ordinary skill having the benefit of
this disclosure.
[0020] After a tracheal tube has been inserted into a patient
airway, an associated balloon cuff is inflated to form a seal
within the tracheal space. The inflated cuff forms a shelf that
blocks secretions from the mouth from traveling into the lungs.
Over time, the secretions may build up on the top of the cuff and
leak down into the lower airway if the seal against the tracheal
walls becomes degraded. Accordingly, tracheal tubes may include
dedicated lumens with apertures located above the cuff. When a
suction force is applied to the suction lumen, secretions are taken
up into the lumen through the aperture. This suctioning process may
be performed on a regular basis, because tracheal tubes are
typically used for days or weeks before being replaced. When the
aperture becomes occluded, e.g., because the secretions are
viscous, it is impractical to replace the tracheal tube with a
fresh tube with a clear suctioning lumen. Accordingly, it is
desirable to be able to detect and clear any blockages in the
suction lumen so that suctioning may continue.
[0021] Provided herein are tracheal tubes that include lumens for
suctioning secretions that may accumulate on an inflated cuff. For
example, the lumens may be associated with suction systems that are
capable of alternating positive and negative pressure to clear
blockages in the suction lumen. The tracheal tubes may also include
one or more sensors for determining if the suction lumens are
blocked. Additionally, the tracheal tubes may include sensors for
determining the presence of and/or the extent of secretion
build-up. Also provided herein are systems for communicating with
the tracheal tubes and associated sensors to inform clinicians if a
suction lumen is blocked or if secretions have built up on the
cuff.
[0022] In certain embodiments, the disclosed tracheal tubes,
systems, and methods may be used in conjunction with any
appropriate medical device, including a feeding tube, an
endotracheal tube, a tracheotomy tube, a circuit, an airway
accessory, a connector, an adapter, a filter, a humidifier, a
nebulizer, nasal cannula, or a supraglottal mask/tube. The present
techniques may also be used to monitor any patient benefiting from
mechanical ventilation, e.g., positive pressure ventilation.
Further, the devices and techniques provided herein may be used to
monitor a human patient, such as a trauma victim, an intubated
patient, a patient with a tracheotomy, an anesthetized patient, a
cardiac arrest victim, a patient suffering from airway obstruction,
or a patient suffering from respiratory failure.
[0023] FIG. 1 shows an exemplary tracheal tube system 10 that has
been inserted into the trachea of a patient. The system 10 includes
a tracheal tube 12, shown here as an endotracheal tube, with an
inflatable balloon cuff 14 that may be inflated to form a seal
against the tracheal walls. A suction lumen 16 terminating in
opening 18 may be disposed on the tracheal tube 12. As shown, an
exterior suction tube 20 connects to the suction lumen 16 for the
removal of suctioned fluids. The suction tube 20 may connected to a
vacuum source 22 and fluid collection canister 23 via additional
connecting tubes. The suction tube 20 and suction lumen 16 are in
fluid communication with a pressure transducer 24 and a pressure
transducer 26. As provided herein, information about pressure at
the pressure transducer 24 and the pressure transducer 26 may be
used to determine information about the suction lumen 16.
[0024] The pressure transducer 24 and the pressure transducer 26
are spaced apart so that a pressure drop between them may provide
information about potential blockages in the suction lumen 16.
Generally, the pressure transducer 26 located closer to a patient
end will experience higher pressure than the pressure transducer 24
located closer to the vacuum source 22 during suctioning of a
clear, unblocked lumen. Accordingly, any change from this expected
pressure drop between the pressure transducer 24 and the pressure
transducer 26 may be indicative of a blockage in the suction lumen
16.
[0025] As noted, the pressure transducer 24 and the pressure
transducer 26 may be associated with the suction lumen 16 and the
suction tube 20. To that end, they may be directly mounted onto one
or both of the suction lumen 16, the suction tube 20, or any
associated tubes, side arms, or connectors in the flow path from
the suction lumen 16 to the vacuum source 22, including the fluid
collection canister 23. As shown, the pressure transducer 24 is
coupled to the fluid collection canister 23. In other
configurations, the pressure transducers 24 and 26 may be disposed
within a shunted pathway from suction tube 20 and fluid collection
canister 23. Further, in certain embodiments, a differential
pressure sensor may be employed. In certain embodiments, a
connecting tube that includes the pressure transducer 24 and the
pressure transducer 26 and that is adapted to connect to the
suction tube 20 may be packaged with the tracheal tube 12 to be
sold as a kit. Further, in certain embodiments, the pressure
transducer 24 and the pressure transducer 26 may be coupled via
electrical leads or other connections to a connector 28 that may
facilitate connection of the pressure transducers 24 and 26 to a
medical device, e.g., a patient monitor 32.
[0026] The system 10 may also include a respiratory circuit (not
shown) connected to the endotracheal tube 12 that allows one-way
flow of expired gases away from the patient and one-way flow of
inspired gases towards the patient. The respiratory circuit,
including the tube 12, suction lumen 16, and suction tube 20, may
include standard medical tubing made from suitable materials such
as polyurethane, polyvinyl chloride (PVC), polyethylene
teraphthalate (PETP), low-density polyethylene (LDPE),
polypropylene, silicone, neoprene, polytetrafluoroethylene (PTFE),
or polyisoprene. The cuff 14 is formed from material having
suitable mechanical properties (such as puncture resistance, pin
hole resistance, tensile strength), chemical properties (such as
biocompatibility). In one embodiment, the walls of the cuff 14 are
made of a polyurethane having suitable mechanical and chemical
properties. An example of a suitable polyurethane is Dow
Pellethane.RTM. 2363-80A. In another embodiment, the walls of the
cuff 14 are made of a suitable polyvinyl chloride (PVC). In certain
embodiments, the cuff 14 may be generally sized and shaped as a
high volume, low pressure cuff that may be designed to be inflated
to pressures between about 15 cm H.sub.2O and 30 cm H.sub.2O.
Additionally, it should be noted that the cuff 14 may be any
suitable cuff, such as a tapered cuff, a non-tapered cuff, and so
forth.
[0027] The system 10 may also include devices that facilitate
positive pressure ventilation of a patient, such as the ventilator
30, which may include any ventilator, such as those available from
Nellcor Puritan Bennett LLC. The system may also include a monitor
32 that may be configured to implement embodiments of the present
disclosure to determine information about blockages in the suction
lumen 16 based upon the pressure at the pressure transducer 24 and
the pressure transducer 26. It should be understood that the
monitor 32 may be a stand-alone device or may, in embodiments, be
integrated into a single device with, for example, the ventilator
30.
[0028] The monitor 32 may include processing circuitry, such as a
microprocessor 34 coupled to an internal bus 36 and a display 38.
In an embodiment, the monitor 32 may be configured to communicate
with the tube, for example via connector 28, to obtain signals from
the first transducer 24 and the pressure transducer 26. In certain
embodiments, the connector 28 may also provide calibration
information for the tube 12 and/or the pressure transducer 24 and
the pressure transducer 26. The information may then be stored in
mass storage device 40, such as RAM, PROM, optical storage devices,
flash memory devices, hardware storage devices, magnetic storage
devices, or any suitable computer-readable storage medium. The
information may be accessed and operated upon according to
microprocessor 34 instructions. In certain embodiments, calibration
information may be used in calculations for estimating a pressure
drop between the pressure transducer 24 and the pressure transducer
26. The monitor 32 may be configured to provide indications of
blockages in the suction lumen 16, such as an audio, visual or
other indication, or may be configured to communicate the
information to another device, such as the ventilator 22. In
addition, the microprocessor 34 may be programmed with instructions
for controlling the application of the vacuum source 22. For
example, a vacuum may be applied constantly or intermittently.
[0029] The pressure transducers 24 and 26 may be any suitable
pressure sensor that may be integrated into the system 10. For
example, the pressure transducers 24 and 26 may be piezoelectric
pressure sensors connected to leads be soldered or otherwise
coupled to the pressure transducer 24 and 26 and may run along the
length of suction lumen 16, suction tube 20, or any other tubing or
couplers. It should be understood that, while the pressure
transducers may be integrated into or onto an exterior wall of the
lumen 16 or suction tube 20, other contemplated embodiments may
involve proximally located pressure transducers 24 and 26 in fluid
communication, for example through a lumen, with the suction lumen
16 or at various points along the suction pathway.
[0030] The connector 28 may be suitably configured to connect to a
receiving port on the monitor 32. The connector 28 may contain an
information element, such as a memory circuit, e.g., an EPROM,
EEPROM, coded resistor, or flash memory device for storing
calibration information for the pressure transducers 24 and 26. The
connector 28 may also contain certain processing circuitry for at
least partially processing signals from pressure transducers 24 and
26 or for interacting with any memory circuitry provided. When the
connector 28 is coupled to the monitor 32, the information element
may be accessed to provide calibration information to the monitor
32. In addition, the connector 28 may facilitate providing pressure
monitoring information to the monitor 32. In certain embodiments,
calibration information (e.g., the volume of the pressure
transducers 24 and 26, the distance between them) may be provided
in a barcode on the tube or associated packaging that may be
scanned by a reader coupled to the monitor 32. The calibration
information may also be determined by the monitor 32 as a function
of the lumen inner diameter and length. Alternatively, the pressure
transducers 24 and 26 may include a passive or active RFID circuit
that may be read wirelessly to convey pressure monitoring
information and cuff calibration information to the monitor 32. In
other embodiments the relevant calibration data may be provided in
the packaging of the tube 12 and may simply be entered
manually.
[0031] FIGS. 2A-C are exemplary pressure graphs of pressure at PT1
(pressure transducer 26), pressure at PT2 (pressure transducer 24),
and their differential over time as a vacuum suction is applied
intermittently. For example, graph 58 in FIG. 2A shows the sensed
pressure 59 from pressure transducer 26, graph 65 in FIG. 2B shows
the sensed pressure 71 from pressure transducer 24, and graph 72 in
FIG. 2C shows the differential between pressure transducers 24 and
26. During intermittent suctioning of a clear (i.e., free of
blockage) suction lumen 16, the pressure 66 (see FIG. 2B) at
pressure transducer 24 is somewhat higher than the pressure 60 (see
FIG. 2A) at the pressure transducer 26. This is due to the relative
pressure drops of the air flowing through the suction lumen 16 and
the suction tube 20. During intermittent suction, this is seen as a
pulse of the characteristic clear pressure 60 at pressure
transducer 26 and a pulse of the characteristic clear pressure 66
at pressure transducer 24. The difference between the pressure 66
and the pressure 60 is the characteristic pressure drop 74 (see
FIG. 2C) seen with a clear lumen.
[0032] When the suction lumen opening 18 becomes covered in
secretions so that the suction lumen is blocked, the pressure 67 at
the second pressure transducer 24 increases while the pressure 61
at the first pressure transducer 26 remains constant, which results
in substantially no pressure drop between the two transducers 24
and 26. As shown in FIG. 2C, equal pressure period 76, showing
either no pressure drop or a small pressure drop where the
pressures at pressure transducers 24 and 26 are approximately
equal, may be indicative of a blocked lumen 16. In the depicted
example, the substantially equal pressure period is temporary as
the suction is maintained. The suction, if sufficient to clear the
blockage, pulls the secretions through the suction lumen 16 until
the secretions reach the location of the second pressure transducer
26. At the point where there is still fluid in the suction line,
but the fluid has passed the pressure transducer 26, the pressure
in the pressure transducer 24 will drop to a pressure 68 that is
lower than the unblocked pressure 66. This is because, as opposed
to the case of an unblocked tube, the viscous fluid between the two
pressure transducers 24 and 26 will cause a larger pressure drop 78
relative to the pressure drop 74 associated with an air-filled
tube.
[0033] As shown in FIG. 2A, during this period of blockage, the
measured pressure at the pressure transducer 26 remains about the
same. That is, the clear pressure 60, the pressure during blockage
61, the pressure 62 with fluid between the transducers 24 and 26,
and the pressure 63 when the fluid has passed transducer 24 and is
being evacuated, are generally the same. These pressures may be
compared against a calibration pressure 64, which may be obtained
by venting the suction tube 20 and measuring the pressure while the
suction tube 20 is empty.
[0034] In contrast, as shown in FIG. 2B, the pressure at pressure
transducer 24 varies throughout the blockage. When the lumen is
clear, the pressure 66 is lower relative to the pressure 60 at
pressure transducer 26. During occlusion, the pressure 67 increases
and then subsequently decreases to pressure 68 and pressure 69 as
the fluid is pulled through the lumen and into the evacuation
canister 23. These pressures may be normalized to calibration case
70.
[0035] The variance in pressure at pressure transducer 24 over time
because of blockage in the lumen 16 results in a changing pressure
drop, shown in FIG. 2C. In the graph 72, the characteristic
pressure drop 74 when the suction lumen 16 is clear is larger than
the lack of pressure drop 76 experienced during a period of
blockage. When the fluid moves through the lumen 16 and into
suction tube 20, a larger pressure drop 78 is followed by an even
larger pressure drop 80 as the fluid is evacuated. These pressure
drops may be normalized to the calibration differential 82 between
the calibration pressures 70 and 64.
[0036] The monitor 32 may monitor the pressure and use the
resulting pressure patterns or pressure differentials to determine
if the suction lumen 16 is blocked. FIG. 3 is an exemplary process
flow diagram illustrating a method for determining lumen blockage
based on the pressure at the pressure transducer 24 and the
pressure transducer 26. The method is generally indicated by
reference number 90 and includes various steps or actions
represented by blocks. It should be noted that the method 90 may be
performed as an automated or semiautomated procedure by a system,
such as system 10. Further, certain steps or portions of the method
may be performed by separate devices. For example, a portion of the
method 90 may be performed by pressure transducers 24 and 26, while
a second portion of the method 90 may be performed by a monitor 32.
In embodiments, the method 90 may be performed continuously or
intermittently for long-term patient monitoring or at any
appropriate interval depending on the particular situation of the
intubated patient.
[0037] According to a presently contemplated embodiment, the method
60 begins with a measurement of pressure at a first location at
step 92 by the pressure transducer 24 associated with a tracheal
tube 12 that has been inserted into a patient. In addition, at step
94 the pressure transducer 26 measures the pressure at a second
location. The pressure measurements may be communicated to the
monitor 32 for further analysis. In addition, the monitor 32 may
also receive calibration information from an information element or
other storage device associated with the connector 28 that may be
used to calculate the pressure. It should be noted that the monitor
may, of course, receive data or signals directly from the pressure
transducers 24 and 26. At step 98, a pressure drop is determined
from the pressures measured at steps 92 and 94. Based on the
pressure drop from step 98, a monitor 32 may determine whether the
suction lumen 16 is blocked at step 100. For example, if there is a
characteristic pressure drop 74 associated with clear lumen 16, the
monitor 32 may determine that the suction lumen 16 is clear. It
should be understood that the calculated pressure drop may be
within a standard deviation from the characteristic pressure drop
74. Further, a characteristic pressure drop 74 may vary from device
to device (e.g., may vary with the size of the tube 12).
Accordingly, the particular characteristic pressure drop 74 may be
calibrated based on empirical calibration values that are stored in
the connector 28.
[0038] If the suction lumen 16 is clear, the method 90 returns to
step 92. In particular embodiments, prior to the first time that
steps 92 and 94 are performed, the suction line may be vented or
occluded so that reference or calibration baseline pressures (e.g.,
pressures 64 and 70) at the transducers 24 and 26 may be collected.
The method 90 may be also performed in conjunction with constant or
intermittent suctioning. For example, in certain embodiments, steps
92 and 94 may be coordinated with the timing of the application of
a vacuum to the suction lumen 16. In such embodiments, the measured
pressure drop may be determined during periods that suction is
applied. When the suction lumen 16 is clear, the vacuum may be
applied infrequently, such as every ten minutes for about five
seconds, unless a blockage is detected.
[0039] If, at step 100, the monitor 32 determines that the suction
lumen is blocked, for example by detecting an equal pressure period
(e.g., exemplified by a small or substantially no pressure drop as
in pressure differential 76), the method 90 may apply a vacuum at
step 102 so that the secretions in the suction lumen 16 can be
cleared. The monitor 32 may then look for the characteristic
pressure drop 74 that indicates that the suction is pulling the
secretions through the lumen to clear them at step 104. If the
characteristic pressure drop 74 is detected, the monitor may wait
until the pressure pattern returns to the characteristic pressure
drop 74 associated with a clear lumen and then cease applying. In
this manner, the vacuum source may be applied infrequently and only
sustained during periods in which the lumen is blocked. Once the
suction lumen 16 is clear, the method 90 returns to step 92. If, on
the other hand, there is no characteristic pressure drop 74 and the
pressure at the first pressure transducer 26 remains substantially
the same as the pressure at the second transducer 24, an alarm or
other indication of blockage may be triggered at step 108 so
additional clearing measures may be taken. In other embodiments,
the vacuum force may be increased until the blockage is
cleared.
[0040] As noted, equal pressure period 76 may predict a blocked
lumen 16, while a pattern of an equal pressure period 76 followed
by larger pressure drops 78 and 80 is characteristic of pressures
that occur as the lumen 16 is being cleared. Accordingly, equal
pressure period 76 may serve as a trigger to continue pressure
monitoring to determine if the blockage is being cleared. Further,
it should be understood that the monitor 32 may determine that a
blockage has occurred if any part or combination of the a
characteristic pressure pattern (e.g., pressure drop 76 followed by
characteristic pressures 78 and 80) is detected, including the
equal pressure period 76, the pressure drop 78, a larger pressure
drop 80, and a return to the normal clear pressure 66 or the normal
pressure drop 74.
[0041] The monitor 32 may be configured to provide a graphical,
visual, or audio representation of a blockage in the suction lumen
16. For example, a clear lumen 16 may be indicated by a green light
indicated on a display, while a pressure differential pattern
indicating a blockage in the suction lumen 16 may trigger an alarm,
which may include one or more of an audio or visual alarm
indication. In one embodiment, the alarm may be triggered if a
change from the characteristic pressure drop 74 is substantially
greater than a predetermined value, substantially less than a
predetermined value, or outside of a predetermined range.
[0042] While a blockage in the suction lumen 16 may be detected by
indirect measurements of the pressure differential at proximal
locations along the suction path, the buildup of secretions around
the lumen opening 18 may be directly measured by appropriately
placed sensors. FIG. 4 is a perspective view of an exemplary
tracheal tube 12 according to certain presently contemplated
embodiments. The tube 12 includes a cuff 14 that may be inflated
via inflation lumen 42. The cuff 14 may be connected to the tube 12
via a proximal shoulder 114 and a distal shoulder 116. A suction
lumen 16 may be formed in the tube walls running parallel to the
airflow path of the interior airflow lumen 118. The suction lumen
16 terminates in opening 18, located above the proximal shoulder
114. The tube 12 forms a slight curve along its length for ease of
insertion into the patient. The curve defines an inside face 120 of
the tube that, when inserted into the patient, faces dorsally. The
opening 18 may be located on the inside face 120. A secretion
sensor 122 is located on the tube 12 between the opening 18 and the
proximal shoulder 114. When the tube 12 is inserted into a patient,
secretions may build up on the cuff 14. These secretions first
encounter the secretions sensor 112 before reaching the level of
the cuff. The secretion sensor 122 is configured to communicate
with a monitor 32 to provide an indication of secretions buildup.
As shown, an imaginary axis 124 drawn through the secretion sensor
122 and the opening 18 may be approximately parallel to the airflow
path. In other embodiments, the secretion sensor 122 may be placed
at other circumferential locations on the tube 12 between the
opening 18 and the proximal shoulder 114.
[0043] The secretion sensor 122 may be a pressure sensor, a
capacitive sensor, a gas sensor, a thermal sensor, or a conductive
sensor. For example, a thermal sensor may experience an increase in
temperature as secretions surround it. A gas sensor may experience
a decrease in detected gas in the ambient air as the secretions
block the gas from encountering the sensor 122. The information
provided by the secretion sensor 122 may be used to control the
application of a vacuum to the suction lumen 16. In certain
embodiments, a vacuum may only be applied when secretions are
detected. The tube 12 may include a connector 28 that facilitates
coupling of the sensor 122 to a patient monitor, e.g., monitor 32.
In addition, the tube 12 may include an addition lumen (not shown)
for adding saline or another fluid to the secretions to decrease
their viscosity and aid suctioning. Alternatively, the lumen 16 may
be used to deliver saline.
[0044] When a tracheal tube 12 is inserted into a patient, the
patient is generally in an inclined position. Shown in FIG. 5 is a
side view of a tracheal tube 12 inserted into a patient airway. As
secretions 128 flow down from the mouth, they begin to build up
above the cuff 14. However, because the tracheal tube 12 is at an
incline, the secretions may spread around the area above cuff 14,
leaking from the dorsal side 130 to the ventral side 132 (shown by
arrows 134). In addition, the secretions may spread in a proximal
direction, forming a pool around the opening 18. In one embodiment,
a tracheal tube may include any number of addition secretion
sensors, e.g., secretion sensors 122a, 122b, 122c, and 122d, placed
at appropriate locations around the tube 12 to provide information
about the extent of the secretion buildup. For example, the
secretion sensor 122a is between the opening 18 and the proximal
cuff shoulder 114, and the secretions sensor 122b is above the
opening 18. The secretion sensor 122b may provide information about
the extent of pooling around the opening 18. Pooling may be more
extensive if both sensors 122a and 122b are covered. Additionally,
secretion sensors 122c and 122d may be located towards the ventral
side 132 to detect leaking of secretions around the cuff 14.
Similarly, FIG. 6 illustrates a side view of a region of the tube
12 surrounding an opening 18. In this alternative embodiment, the
secretion sensor 122 may be annular or semi-annular so that the
secretion sensor 122 at least partially surrounds the opening 18.
The secretion sensor 122 may be configured so that an indication of
secretion buildup may include information about the percentage of
the annular opening 18 that is covered. In another embodiment,
rather than a single annular secretion sensor 122 surrounding the
opening 18, a tube 12 may include a plurality of individual
secretion sensors 122 that surround the opening 18.
[0045] Secretion sensors 122 may also be associated with multiple
suction lumens 16 to that may provide redundant suctioning
functionality. As shown in FIG. 7, a side view of a region of a
tube 12 above the cuff 14, the tube 12 may have multiple suction
lumens 16 (shown as 16a and 16b), each terminating in respective
openings 18a and 18b. Secretion sensors 122a and 122b may be
associated with each opening 18. If, for example, suction lumen 16a
is blocked, as indicated by secretion sensor 122a, suction may be
redirected to suction lumen 16b until suction lumen 16a is
cleared.
[0046] As provided herein, a tube 12 may be associated with a
suction system that includes connectors configured to couple the
lumen 16 to a vacuum source 22 and a fluid collection canister 23.
The vacuum source 22 may be provided as a standard vacuum pumping
system and may include any suitable regulator to control the flow
of the negative pressure. For example, a vacuum pump set to -100 mm
Hg may be reduced to -20 mm Hg suctioning pressure via a valve. In
addition to a vacuum source, a system 10 may also include a source
of positive pressure air. In certain embodiments, when a suction
lumen 16 is blocked, a combination of negative pressure air and
positive pressure air may be used to clear the blockage.
[0047] FIG. 8 is an exemplary suctioning system 150 that includes a
vacuum source 22 coupled to a positive pressure unit 152 via
suction line 154, which is coupled via any appropriate combination
of tubing and connectors to suction tube 20 and suction lumen 16.
The positive pressure unit includes a pressurized air source 155
that may be coupled to the suction line 154 via a one-way valve.
The vacuum source 22 is regulated by valve control 156. When a
downstream blockage in the suction lumen 16 is detected, for
example via a change of pressure detected at one or more pressure
transducers 157 associated with suction line 154, suction tube 20,
or suction lumen 16, the valve control 156 may increase the vacuum
pressure applied to line 154 (e.g., from -20 mm hg to -50 mm Hg) in
an attempt to clear the blockage. If, after a period of time, the
pressure does not drop, indicating that the lumen is not clear, the
positive pressure from the positive pressure unit 152 may be blown
air down the suction line 154 to clear the blockage. The
pressurized air is then used to eject the mucus plug from the lumen
back into the trachea.
[0048] The valve control 156 may increase the vacuum pressure and
duration of its application through additional cycles. For example,
during additional cycles, vacuum pressures of -70 mm Hg and -90 mm
Hg may be used. After each vacuum pressure cycles, positive
pressure may be applied, even if the lumen is not yet clear. The
cycle of alternating negative and positive pressure may break up
the secretions, allowing them to be more easily cleared through the
lumen 16. That is, the secretions may be broken into smaller pieces
or may be in more liquid form that is less likely to block the
lumen 16.
[0049] Positive pressure unit 152 is coupled to the suction line
154 so that a source of pressurized air 156 is able to provide
positive pressure air into the suction line 154. In one embodiment,
the positive pressure unit may be a unitary device that has an
upstream connector 158 and a downstream connector 160 so that the
positive pressure unit 152 may be connected in-line with the
suction line 154. As such, the positive pressure unit 152 may be
provided as an upgrade to an existing suctioning system. The
positive pressure unit 152 may include processing circuitry, such
as a microprocessor 162 and a display 164 that may provide
indications or alarms related to detected blockages. The positive
pressure unit 152 may also include a control input 166, such as a
keyboard or touch screen, that allows an operator to change
settings, such as settings related to the pressure of the air blown
into the suction line 154. The positive pressure unit 152 may also
communicate with one or more pressure transducers 157. Further, the
positive pressure unit may communicate with the valve control 156
so that the vacuum pressure and the positive pressure may be
appropriately alternated to facilitate clearing any blockages.
[0050] FIG. 9A is an cross-sectional view of a positive pressure
system 170 that provides positive pressure air into the suction
line 154 without using a pressurized air canister. When the lumen
16 becomes blocked, the pressure of the air in the suction line 154
increases. The positive pressure system 170 uses the increase in
energy to pressurize ambient air. When the suction line 154
experiences increased negative pressure, the pressure increase
pulls a flap 172 and a moveable member, shown as deformable
membrane 174, towards the suction line 154. This movement in turn
creates a vacuum that draws air, shown by arrow 176, into chamber
178 through one-way valve 180. In other embodiments, the moveable
membrane may be a piston or a spring-loaded cylinder.
[0051] When the vacuum pressure in the suction line 154 passes a
threshold where the spring force or the deforming force of the
moveable member is higher than that of the suction line 154, the
moveable member will be released and will drive the air out of the
change through flap valve 184. As shown in FIG. 9B, the air,
represented by arrow 186, then enters the suction line 154. It
should be understood that the size of the chamber 178 and the
deforming or spring-force characteristics of the moveable member
may be selected to facilitate injection of air into the suction
line 154 at particular pressure points in the suction line 154.
[0052] While the disclosure may be susceptible to various
modifications and alternative forms, specific embodiments have been
shown by way of example in the drawings and have been described in
detail herein. However, it should be understood that the
embodiments provided herein are not intended to be limited to the
particular forms disclosed. Rather, the various embodiments may
cover all modifications, equivalents, and alternatives falling
within the spirit and scope of the disclosure as defined by the
following appended claims.
* * * * *