WO2007050051A2

WO2007050051A2 - Improved endotracheal tube system and method of use

Info

Publication number: WO2007050051A2
Application number: PCT/US2005/037805
Authority: WO
Inventors: Rick J. Tresnak; Emil J. Tresnak
Original assignee: Chrickemil, Llc
Priority date: 2005-10-21
Filing date: 2005-10-21
Publication date: 2007-05-03
Also published as: WO2007050051A3

Abstract

An improved endotracheal tube system (10) and method of use is provided. The improved endotracheal tube system includes a standard endotracheal tube (14), a housing (12) with a first tube (26) that may be positioned within an endotracheal tube and a second tube (28) adapted for attachment to a bag-valve mask. The housing has a C02 detector (36) within it. The improved endotracheal tube system may also have a stylet positioned within the endotracheal tube and the housing, a structure for directing air from the endotracheal tube unidirectionally to the carbon dioxide indictor, an exhaust port, and a seal or exhaust return tube over the exhaust port.

Description

METHOD OF USE

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-In-Part of U.S. Patent Application No. 10/829,033 filed on April 21, 2004, the contents of which are hereby incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

The invention relates generally to the field of medical devices. Specifically, the invention relates to an endotracheal tube system that provides for proper placement of the endotracheal tube and for subsequence carbon dioxide detection.

A serious problem in the resuscitation of patients is the fast and efficient insertion of an endotracheal tube into a patient and then determining if the tube is in correct placement within the trachea. A medical professional responding to a patient who is not breathing has very little time to react because brain damage occurs after only four minutes without oxygen and brain death occurs at eight minutes without oxygen. Therefone-jujped exists to provide the medical professional with an improved endotracheal tube system and method of use which quickly and efficiently places the endotracheal tube within the patient and tests for proper placement.

Capnography is the term generally associated with monitoring carbon dioxide (CO₂) levels in an expired breath. Capnography specifically is the process of monitoring the concentration of exhaled carbon dioxide in order to assess the physiological status of patients. receiving mechanical ventilation and to determine the adequacy of ventilation. It is difficult for the medical professional using a respirator to determine whether the patient is receiving an adequate flow of oxygen without some form of capnography. The medical professional must observe whether the lungs are filling with air or whether the stomach is e gurgling because it is filling with air but without some form of capnography the medical professional is not assured whether the patient is receiving an adequate flpw of oxygen. For example, the endotracheal tube may be inserted into the patient's esophagus instead of the trachea. Therefore, a need has arisen for an efficient and economical way of iαe.teπiniiiitiigwωmeρttjΦpat4©ittst3@ing treateα witti a resuscitator is actually receiving oxygen.

Carbon dioxide detectors are well known in the prior art for use with an endotracheal tube. However, the prior art carbon dioxide detectors are both cumbersome and time consuming. Moreover, the prior art carbon dioxide detectors are not integral with the endotracheal tubes and therefore create problems when assembling prior to use upon a patient. Accordingly, an objective of the current invention is an improved endotracheal tube system which incorporates a CO₂ detector directly to an endotracheal tube, creating a single device. There have been attempts in the prior art to design a resuscitator that integrates a carbon dioxide detector. An example of such a device is disclosed in U.S. Patent No. 6,427,687 to Kirk. Unfortunately Kirk is both time consuming and cumbersome because it incorporates a carbon dioxide detector into the resuscitator. Therefore, a medical - ^• professional using Kirk must incorporate a disposable CO₂ detector upon the regulator thus requiring an additional step above merely inserting the endotracheal tube into the patient. A further example of a combination carbon dioxide detector and resuscilator is disclosed in U.S. Patent No. 6,584,974 to Ratner. Ratner attaches the CO₂ detectϋisfeeetly to the . resuscitator and has the same disadvantages as the Kirk patent. Accordingly, it is an objective of the present invention to incorporate the CO₂ detector in an adapter that may be placed between the endotracheal tube and a bag valve mask.

A further problem in the prior art is the inability to administer medications through the endotracheal tube without coming in direct contract with a carbon dioxide indicator. U.S. Patent Nos. 4,879,999 to Leiman discloses a device for determining of proper endotracheal tube placement using a carbon dioxide indicator in open contact with the endotracheal tube; therefore, medication placed into the tube may easily contact the carbon dioxide indicator. Moreover, the Leiman patent may use support structure that makes the CO₂ housing cumbersome. Accordingly, it is a still further objective of the present invention to have a structure that prevents the carbon dioxide indicator from being contacted with medicine and to use the minimum of space outside the air channel of the - housing to prevent a cumbersome structure. < m 'px t J n i n s is e i cu y in p acing the endotracheal tube within the trachea. This difficulty is overcome using a metal stylet placed within the endotracheal tube before insertion into the patient. The stylet provides rigidity to the endotracheal tube which provides the medical professional control of the flexible plastic tubing of the endotracheal tube. The stylet is not reusable and must be disposed after every use. The stylet is necessary in emergency situations to assist in manipulating an endotracheal tube through the glottic opening of the trachea that may be closed, partially collapsed, or blocked. The medical professional, because he or she may not know of the problems associated with the trachea, must use the stylet as a default for manipulating the endotracheal tube. Accordingly, an objective of the present invention is to incorporate a stylet into the endotracheal tube system.

Furthermore, prior art stylets commonly bend when pulling the stylet from the endotracheal tube and add to the risk of accidental removal of the tube from the trachea- Accordingly, an objective of the present invention is to incorporate an affixed handle to prevent bending and assist in the removing of the tube from the trachea. Additionally, the stylet and handle may be in close proximity to a carbon dioxide detector that needs to be protected from outside air. Accordingly, it is a still further objective to provide a handle that has the capability to block outside air from contacting the carbon dioxide detector.

A still further objective of the present invention is to minimize the amount of pieces and assembly required by medical personnel. Every additional piece that is not preassembled creates increased search time for the pieces, the possibility of dropping the. pieces, and the concern for inadequate attachment of multiple parts of the assembled system. Therefore, a further objective of the present invention is to create an improved endotracheal tube system which has all pieces preassembled into a combination such that only a resuscitator or bag valve mask needs to be attached it.

A still further objective of the present invention is to minimize the amount of time for capnography and subsequent verification of endotracheal tube placement within the trachea as opposed to the esophagus. It is of the utmost concern that no time is wasted for attaching and assembling pieces to, the endotracheal tube that could have been preassembled and packaged. uπ-aaffliwOHH l-s s 't u ner o jec ive o e presen inven ion o pro uce an improved endotracheal tube system that is sold as a set as opposed to the individual pieces of an endotracheal tube, a CO₂ tube detector, and a stylet. The set can be sold for a reduced price as opposed to the individual prices set for individual pieces. These and other objectives of the present invention will become apparent from the following description of the invention.

SUMMARY OF THE INVENTION

The improved endotracheal tube system utilizes an adapter that is placed between an endotracheal tube and the bag- valve mask. The adapter has a housing having a first tube for attachment to an endotracheal tube and a second tube for attachment to a bag-valve mask. The adapter has a carbon dioxide indicator within the housing that is in gaseous communication with the endotracheal tube but isolated from the outside atmosphere. The adapter has a fin to direct air from the second tube unidirectionally to the carbon dioxide indicator.

The improved endotracheal tube system has an endotracheal tube, a housing containing a first tube attached to the endotracheal tube and a second tube for attachment to a bag-valve mask. The system also having a stylet placed within the endotracheal tube and the housing to provide temporary rigidity to the endotracheal tube. The improved endotracheal tube system may also have a carbon dioxide indicator within the housing and fins that project into the first tube to impede airflow from the endotracheal tube and direct the airflow to the carbon dioxide indicator. Additionally, the system may have a handle attached to the stylet that facilitates removal of a stylet from the endotracheal tube in the adapter but with handle having seals upon it which prevent the outside atmosphere air interacting with the carbon dioxide indicator.

In the method of the invention, an improved endotracheal tube system is supplied to the medical professional. The medical professional positions an endotracheal tube of the system into a patient. The medical professional will then remove the stylet from the endotracheal tube and..a housing. The medical professional then places a bag-valve mask upon the housing and ventilates the patient. One ventilation cycle effectively creates a color change in the carbon dioxide indicator of the system. If the carbon dioxide indicator _" 'i_Bwey* _^¥JΉ,'^ « . v, i i . endotracheal tube is not properly placed, no color change will be apparent. If incorrectly placed, vomit or other stomach contents may enter the endotracheal tube and, consequently, the endotracheal tube must be discarded. Medicine may be administered to the patient through the housing because fins protect the carbon dioxide indicator.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure l is a front view of the improved endotracheal tube system of the present invention. Figure 2 is an exploded view of the adapter with carbon dioxide detector and a stylet having a handle attached to it.

Figure 2A is a sectional view along line 2A-2A of Figure 2. Figure 2B is an alternate embodiment of the adapter having the carbon dioxide detector held in tracks. Figure 3 is an exploded view of an alternate embodiment of the improved endotracheal tube system.

Figure 3A is a sectional view along 3A-3A of Figure 3. Figure 3B is a partially cut away housing of Figure 3.

Figure 4 is a picture of the prior art endotracheal tube system with a bag-valve mask attached to it.

Figure 4A is a front view of the adapter of Figure 2.

Figure 5 is the improved endotracheal tube system of the present invention being inserted into a patient.

Figure 6 is the improved endotracheal tube system of the present invention with the handle and stylet removed from the endotracheal tube.

Figure 7 is the improved endotracheal tube system of the present invention with the bag-valve mask attached to the adapter.

Figures 8A-C are views of an alternate embodiment of the adapter using a one-way valve. . , ■ : Figures 9A-B are views of an alternate embodiment of the adapter using tubes connected to inlet holes and extending below the flange.

3$ a^'vJSW^'cPM a ternate em o ment o t e a apter using air dams positioned over the inlet holes and extending below the flange.

Figures 1 IA-B are views of an alternate embodiment of the adapter using twisted colorimetric paper. Figure 12A-B are views of an alternate embodiment of the adapter using one-way flaps.

Figure 13 is a view of an alternate embodiment of the adapter having a seal covering the exhaust ports.

Figures 14A-B are views of alternate embodiments of the adapter using rubber flaps covering the exhaust port.

Figure 15 is a view of an alternate embodiment of the adapter using exhaust port tubes.

Figures 16A-B are alternative embodiments of the stylet with a handle and bell- shaped barrier to cover exhaust ports in the adapter. Figures 17 A-D are alternate embodiments of the adapter with a flexible seal that occludes exhaust ports if a vacuum occurs from within the tube.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to Figure 1, the improved endotracheal tube system is generally designated by the reference numeral 10. The system has an interconne.ctive housing 12 that attaches to a standard endotracheal tube 14.

The endotracheal tube 14 has a distal end 16 that is positioned within a patient's trachea. The endotracheal tube 14 also has a proximal end 18 in which the adapter 12 is placed. A standard endotracheal tube has a balloon 20 that is inflated once the endotracheal tube 14 is positioned in the patient. The balloon 20 prevents accidental withdrawal of the endotracheal tube from the trachea and specifically movement past the patient's vocal chords. The balloon 20 is inflated by placing a syringe 22 into the balloon inflating apparatus 24. The standard endotracheal tube may also have medication ports, suction ports, and other ports as disclosed in the prior art. The housing 12 has a first tube 26 that fits into the proximal end 18 of the endotracheal tube 14. The first tube 26 may be tapered for insertion into various sizes of PM(apuEa , ; i ; .t i , c a n tube to form an assembly. The first tube may be various sizes depending upon the size of the endotracheal tube 18 used. Endotracheal tubes 18 may vary depending on the size and age of the patient. The housing has a second tube 28 for attachment to a bag-valve mask. The second tube 28 has an outer diameter that may range between 12 millimeters (mm) to 20 mm and preferably has an outside diameter of 14 mm with an inner diameter of 13 mm. The cylinder is preferably .16 mm to 24 mm in length with a preferred length of 18 mm.

As seen in Figure 2, on the base of the second tube 28 are six holes equally spaced around the circumference of the second tube 28. The holes 30 measure approximately 3 mm in diameter. As seen in Figure 2A, a ring 32 with a C-shaped cross section defining a ring chamber 34 is adapted to be placed over the second tube 28. Inside the ring chamber 34 is placed a carbon dioxide indicator 36. Litmus paper is chemically treated colorimetric indicator paper that may be used to detect carbon dioxide. The carbon dioxide detector 36 goes into ring 32. The ring 32 may then be slid over the second tube 28 and positioned against flange 38. The ring 32 is then secured in place. The ring may be secured using adhesive between the interface of the ring 32 and second tube 28 and the ring 32 and flange 38. As seen in Figure 2B, the carbon dioxide detector may be held in tracks 35 of the ring 34.

As seen in Figure 3, an alternate embodiment of the adapter 12 is illustrated. Similar to the housing 12 of Figures 1 and 2, the. alternate embodiment housing 12A has a first tube 26 and a second tube 28. On the base of the second tube 28 are four holes equally spaced around the circumference. These holes measure approximately 4 mm in diameter. Immediately above the holes is a fin 31. Fin 31 is more clearly seen in Figures 3A and 3B. As seen in Figure 3B, the fins act to direct air coming up the endotracheal tube 14 into hole 30 so that it may influence the carbon dioxide indicator 36. The fins 31 project into the second tube to impede airflow from the endotracheal tube 14 and direct the airflow to the carbon dioxide indicator. The air is directed away from the fin 31 moves in a unidirectional direction to the carbon dioxide indicator 36 to facilitate a color change. The fins 31 also facilitate the administering of medicine to the housing without damaging the carbon dioxide indicator 36. A sHt 37 may be in ring 32 to help promote unidirectional flow of air past the CO₂ indicator 36. Medicine coming from outside the endotracheal tube 11-4¹M αirect@α^;©54itn© .nnssor ©trier- unidirectional aiπiow enaoimg structure, away rrom holes 30, and down into the endotracheal tube 14 using fins 31, is unlikely to enter into medicine holes 30 to damage the carbon dioxide indicator 36.

Although the fins 31 are illustrated as causing unidirectional airflow other structures may be provided for unidirectional airflow. For example, a one-way valve may be used to direct air from the ET tube 18 across the CO₂ indicator 36 but not permit air from the bag-valve mask 48. Additionally, there could be multiple variations of a unidirectional airflow system made in the ET tube housing such as a directional ring or cone. Furthermore, the number of fins 31 may be varied. A stylet 40 is placed within the endotracheal tube 14 and the housing 12. A stylet provides rigidity to the endotracheal tube when being placed within a user's trachea. The stylet is attached to handle 42. The handle 42 has a plug 44 with seals 46 upon it. The plug 44 and seals 46 press upon the inner chamber of the housing 12 so that air cannot come in contact with the CO₂ detecting paper 36. Figures 1 and 2 illustrates one seal 46 above the holes 30 and a second se^~al 46 below the holes 30. Figure 3 has a gasket type seal above the holes 30 and a plug type seal below the holes 30. The position of the seals 46 is relevant because the distal endT6 of the endotracheal tube 14 is not sealed.

The present invention may be embodied as an assembly including an endotracheal tube 14, a housing 12, and a stylet. The prior art has never addressed this assembly combination which is of a necessary benefit to. emergency medical professions. Different types of housings including CO₂ detectors may be substituted such as those by Leiman, U.S. Patent No. 4,879,999, and Riccitelli, U.S. Patent No. 5,124,129.

As seen in Figure 4, the prior art used a cumbersome CO₂ detector having one end 104 that attaches to an endotracheal tube adapter 106. As seen in Figure 4A, an endotracheal tube adapter 106 used in the prior art is of the same general size as the housing 12 of the present invention but does not utilize any carbon dioxide indictor that is in gaseous communication with the endotracheal tube and isolated from the outside air or atmosphere. The CO₂ detector 102 in the prior art also has a second end 108 that is adapted to receive a bag-valve mask 48. One additional embodiment may utilize at least one angled hole in the endotracheal- tube positioned to direct air to the detector in an unidirectional manner. 14A-B, and 15.

As seen in Figure 8A, a one-way valve 50 may be provided for use in an adapter 12. The one-way valve is a small cone shaped valve that may be made of either a latex product or other pliable rubber product. The one-way valve 50 is located above the holes 30 and allows inhaled air to pass down through the adapter but not come in contact with the indicator 36 but permits exhaled air to cause a constriction in the one-way valve 50 which would direct air through holes 30 across carbon dioxide detector 36 and out slits 37. Figure 8A illustrates a side view of the one-way valve 50, Figure 8B illustrates a top view of the one-way valve 50 showing a hole through the center of the one-way valve 50, and Figure 8C illustrates the one-way valve 50 in use with an adapter 12.

Figures 9 A and 9B illustrate an adapter 12 using tubes 52 extending down through the length of the adapter housing 12 through its inner lumen. These tubes 52 may pass below the level of the adapter flange 38. The upper end of the tubes 54 are attached to holes 30 and the lower end 56 extends below flange 38. The tubes 52 function to create a tunnel for the exhaled air to pass through and allow it to contact indicator 36 without mixing with the inhaled air.^' Slf#67 may be provided to facilitate exhaled air passing through the CO₂ indicator.

Figure 10 illustrates the incorporation of four L-shaped air dams 58. The air dams 58 extend down through the adapter housing 12 and past flange 38 of the adapter housing 12. The attached end of the air dam 58 would be positioned above the four holes directing air through the holes 30 and in contact with the indicator 36. Slits 37 may be provided to assure good exhaled air passing through the indicator 36.

As seen in Figures 1 IA and 1 IB, the indicator 36 may be twisted to provide dynamic air flow which permits both sides of the indicator 36 to be exposed equally and at the same time.

Figures 12A-B illustrate the incorporation of one-way flaps 60 which are adjacent the inner lumen of the adapter covering the hole 30 during an inhale movement of air and ' open during'an exhale movement of air from the patient. The flaps 60 use- a hinge built directly into the adapter 12. The flaps occlude the downward air flow from being transferred from the tube and into contact with the indicator paper 36 and only expired air croriHng upHneieneeiracfleai euo^Gouiα pusn tne nap oυ sucn that exhaled air may enter and contact the indicator 36. Slits may be provided to assure good air travel through the indicator paper 36.

When using a slit as per Figures 3B, 8C, 9A, 9B, 10, and 12, as seen in Figure 13, a seal 62 with lift off tab 64 may be provided to cover the slits 37 to assure that atmospheric air does not contact the colorimetric indicator paper 36 when the endotracheal tube is removed from a protective outer package but not yet in place within a patient. Alternatively, as seen in Figures 14A and 14B, exhaust flaps 66 may be provided to also cover slits 37. These exhaust flaps do not necessarily need to be removed prior to use within a patient to protect the indicator paper 36.

As seen in Figure 15, an exhaust port 68 may be used that would allow for the expired air to vent back into the device and into the main lumen of the adapter 12.

Figures 16A and B illustrates the incorporation of a bell-shaped barrier 70 in use with a stylet 40 and handle 42. The bell-shaped barrier 70 may be rigidly affixed to the handle 42 or it may slide up and down upon the handle. The bell-shaped barrier 70 has a lower end 72 that extends downward to engage the exhaust ports of an adapter. A seal 74 may be providedUiitSe lower most end of the bell-shaped barrier 70 to ensure a proper seal with the flange or other part of the adapter near the exhaust port. Figure 16A is a side view of the bell-shaped barrier 70 whereas Figure 16B is a cross-sectional view of the bell- shaped barrier 70.

Figure 17A is an exploded view of an adapter 12 using a flexible barrier 76 that ensures consistent unidirectional air flow through the medical device. The flexible barrier is O-shaped and positioned such that it is normally at rest as seen in Figure 17C to permit the exhaust ports to remain open but would occlude the exhaust ports if a vacuum occurs from within the adapter 12, such when the patient unexpectedly inhales.

As seen in Figure 17 A, the adapter 12 has a first tube 26 that has a tapered bottom end for attachment to the endotracheal tube, a top end and a flange therebetween. The adapter 12 also has a second tube 28 for attachment to a bag valve mask that is separate from the first tube. A ring 32 is fitted upon the second tube. The second tube -28 has a lower end with at least one orifice 30 that is in gaseous communication with an indicator 36. The exhaust ports 37 are positioned on a bottom side of the ring 32 as opposed to the iBrα^oϊ tnffirWϊϊjg'i-S-iSes.s^'egϊSAn iJ t t e ex e ar er s at rest un erneat t e exhaust ports 37 when there is no vacuum within the adapter 12; however, as seen in - Figure 17D, should there be a vacuum in the adapter 12, the flexible flap 76 bends upward and occludes the exhaust slit 37. The prior art as seen in Figure 4 has four discreet pieces. The first two pieces being the endotracheal tube 14 with a standard adapter 106. These two pieces are typically supplied together and are sealed in a separate package. The third piece is the CO₂ detector 102. The CO₂ detector 102 comes in a separate bag. The fourth piece is the stylet 110 which is a separate piece removed from the endotracheal tube 14 and adapter 106 before placing the CO₂ detector 102 upon the adapter 106. The bag-valve mask 48 is reusable and therefore not considered as an additional piece. The following table illustrates the number of steps and times associated with using the prior art color CO₂ detector 102.

As seen in the above table, the best case scenario for emergency medical personnel to insert an endotracheal tube into a person is 64 seconds. The worst case Scenario takes much more time. A medical professional is under an extreme amount of stress knowing that in four minutes a person will encounter brain damage and thai in eight minutes a

Θ*aιtiiid.ieSailte ^'l^'herefore, the medical professional will be experiencing both adrenaline and anxiety. In addition, the medical professional may have problems and find the trachea obscured by the tongue or fatty deposits in the mouth. In addition, the worst case scenario may take much more time because the color change did not indicate that the endotracheal tube was in the trachea and then the medical professional must go back and repeat the steps beginning at Step 1. In addition, the medical professional may accidentally withdraw the adapter 106 from the endotracheal tube 14 when removing the CO₂ detector 102 and then the person will again have to repeat Step 1. In summary, the best case scenario for the prior art method of detecting CO₂ may range between 64 to 126 second. The worst case scenario may range much longer than two minutes and creep dangerously close to the four minute mark for brain damage and the eight minute mark for brain death. Obviously, with the medical professional also having to encounter delaying issues such as being transported to an accident site on the highway every second matters. The present invention as seen in Figures 5-7 reduce the amount of steps and time.

These reductions decreases the best case scenario time for inserting the endotracheal tube and limits the possibility for error encountered.

TABLE 2: The Present Invention's Steps for Inserting an Endotracheal Tube and Ventilating.

As seen in the above table, the best case scenario results in a process which takes between 34 to 62 seconds and reduces the amount of steps from47 to 8.. In addition, the ventilation step is 5 seconds as opposed to 10-15 seconds because this design does not require a filter pad between the litmus paper and the inner surface of the second tube- 28 !| e μφ u <m τe o e ₂ e ec or using t e andle 42. 1 he pπor art requires 10-15 seconds because it may require two to three ventilations of the bag as opposed to only one ventilation of the present invention. The present invention also has reduced time because it does not require needless opening of multiple bags but only one bag having the combination within it. The present invention also has a reduced amount of time in a worse case scenario as the CO₂ detector will not be accidentally removed by having the bag valve removed to remove the CO₂ detector.

As a summary of Figures 5-7, the medical provider first inserts the improved endotracheal tube system into a patient using a Laryngoscope 50. As seen in Figure 6, the medical provider then inflates the balloon 20 using a syringe 22 attached to opening 24. The user can then withdraw the handle 42 from the adapter 12 thus pulling the stylet 40 from the endotracheal tube in the adapter. As in Figure 7, the user then attaches the bag- valve mask or ventilator 48 and compresses the bag to press air into the patient's lungs. The medical provider then permits the bag-valve mask to pull gas from the patient and if it is properly placed on the trachea, it will pull CO₂ rich gas from the user's lungs and direct it to the CO₂ detector and the housing 12. If there is no color change, the medical provider will remove the endotracheal tube 14 from the patient and replace with a fresh tube. If the endotracheal tube is in the trachea, the medical provider will continue to respirate the patient. The method may also include the step removing a seal over the exhaust port 37.

This step adds approximately 1-2 seconds.

The invention has been shown and described above with the preferred embodiments, and it is to be understood that many modifications, substitutions, and additions may be made which are within the intended spirit and scope of the invention. From the foregoing, it can be seen that the present invention accomplishes at least all of its stated objectives.

Claims

_

1. An interconnection to be placed between an endotracheal tube and bag-valve mask, the interconnection comprising: a housing with a first tube for attachment to an endotracheal tube and a second tube for attachment to a bag- valve mask; a carbon dioxide indicator within the housing, in gaseous communication with the endotracheal tube, and isolated from outside air; the housing having at least one inlet orifice in the perimeter of the second tube, a carbon dioxide indicator covering the orifice, a barrier separating the carbon dioxide indicator from the outside air; a structure for directing air from the endotracheal tube unidirectionally to the carbon dioxide indicator;

^"an outlet orifice in the barrier to promote unidirectional air flow; and a removable seal over the outlet orifice.

2. The interconnection of claim 1 wherein four orifices are spaced around the second tube and the carbon dioxide indicator surrounds the second tube over the orifice and-the?? structure is a fin above each orifice.

3. The interconnection of claim 1 wherein the outlet orifice is in the lower portion of the barrier and exhausts to the outside air.

4. A combination comprising: an endotracheal tube; a housing with a first tube attached to the endotracheal tube and a second tube for attachment to a bag-valve mask; the housing having at least one orifice in the perimeter of the second tube, a carbon dioxide indicator covering the orifice, a barrier isolating the carbon dioxide indicator from the atmosphere; a structure for directing air from the endotracheal tube unidirectionally to the carbon dioxide indicator; ιτa w ψw vi i v _ ;^;eiji f r ea u e an e a ap er o prov e emporary πgiαity o the endotracheal tube.

5. The combination of claim 4 wherein the structure is a one-way valve.

6. The combination of claim 4 wherein the structure is a hollow tube attached to the orifice and extending toward the endotracheal tube.

7. The combination of claim 4 wherein the structure is an air dam.

8. The combination of claim 4 wherein the structure is a one-way flap.

9. The combination of claim 4 wherein an exhaust port tube directs air from the indicator to the second tube.

10. The combination of claim 4 wherein the stylet includes a handle that incorporates the barrier isolating the carbon dioxide indicator from the atmosphere.

11. The combination of claim 10 wherein the barrier is bell-shaped.

12. A method of placing an endotracheal tube within a patient and testing for placement within the patient's trachea, the method comprising: providing a bag- valve mask and an endotracheal tube, a housing attached to the endotracheal tube having a carbon dioxide indicator and an exhaust slit, a stylet within the endotracheal tube and the housing, and a seal over the exhaust slit; placing the endotracheal tube within the patient; displacing the seal over the exhaust slit; removing the stylet from the endotracheal tube and the housing; placing the bag- valve mask upon the housing and ventilating the patient; determining proper placement within the patient's trachea by observing the carbon dioxide indicator.

13. The method of claim 12 further comprising providing hermetically sealed packaging for an assembly of the endotracheal tube, the housing, and the stylet; removing the assembly from the packaging.

14. A medical device, comprising: a unidirectional air flow carbon dioxide detector for exchanging air between an endotracheal tube and a bag-valve mask; an endotracheal tube attached to the detector providing expired air to the detector.

15. The medical device of claim 14 further comprising a stylet within the detector and the endotracheal tube, wherein the stylet provides temporary rigidity to the medical device.

16. The medical device of claim 14 wherein the detector has a gas permeable indicator capable of detecting carbon dioxide.

17. The medical device of claim 14 wherein the endotracheal tube has at least one angled hole positioned to direct expired air to the detector in a unidirectional manner.

18. The medical device of claim 14 wherein the detector limits the measure of dead air space as the endotracheal tube.

19. The medical device of claim 14 wherein the detector includes: a first tube having a bottom end for attachment to the endotracheal tube, a top end, a flange therebetween; a second tube having a lower end with, at least one orifice, a carbon dioxide indicator in gaseous communication with the orifice, a hollow ring having a chamber in gaseous_^ communication with the indicator, at least one exhaust port on the lower end of the hollow ring; a flexible barrier between the exhaust port and the lower end of the hollow ring that occludes the exhaust port if a vacuum occurs from within the detector.

20. The medical device of claim 19 wherein the flexible barrier is O-shaped and fixedly engages the first tube top end over the flange.