MEDICAL DEVICE TUBE HAVING A SUCTION LUMEN AND AN ASSOCIATED SUCTIONING SYSTEM
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.
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.
BACKGROUNDThe 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.
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.
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.
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.
Advantages of the disclosed techniques may become apparent upon reading the following detailed description and upon reference to the drawings in which:
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.
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.
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.
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.
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.
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.
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® 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 H2O and 30 cm H2O. 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.
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.
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.
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.
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.
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
As shown in
In contrast, as shown in
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
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.
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.
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.
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.
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.
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.
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.
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.
When a tracheal tube 12 is inserted into a patient, the patient is generally in an inclined position. Shown in
Secretion sensors 122 may also be associated with multiple suction lumens 16 to that may provide redundant suctioning functionality. As shown in
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.
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.
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.
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
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.
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.
Type: Application
Filed: Jun 13, 2014
Publication Date: Oct 2, 2014
Inventors: Seamus Pio Maguire (Athlone), Lockett E. Wood (Lyons, CO), Brian Ledwith (Co. Longford)
Application Number: 14/304,264
International Classification: A61M 16/04 (20060101); A61M 16/00 (20060101);