Resuscitators, parts and assemblies

A squeeze bag resuscitator has a flow diverter push fitted onto its exhaust outlet in any desired orientation. The diverter has a color change carbon dioxide indicator strip fixed to the inside surface of a transparent deflector plate. The indicator is protected from light externally by an opaque elastomeric strip attached by engaging surface formations to the outside of the plate. The indicator is also protected on the interior of the plate by an opaque strip, which projects from the diverter so that it can be removed by pulling on the free end.

BACKGROUND OF THE INVENTION

This invention relates to resuscitators, parts and assemblies.

Resuscitators are used to ventilate a patient who is not breathing voluntarily. One type of resuscitator has a resilient squeeze bag that is squeezed by hand to administer air to a patient via a face mask, an endotracheal tube, laryngeal mask or the like. The resuscitator has a valve arrangement that directs air to a patient outlet coupling when the bag is squeezed and allows exhaled gas from the patient to flow directly to an exhaust outlet. The valve arrangement also allows air back in to refill the bag when it is released after having been squeezed. Where the resuscitator is used with an endotracheal tube it is important that checks are made to ensure that the tube is correctly placed, that is, to ensure it is in the trachea and not in the oesophagus. One way in which this can be done is by means of a carbon dioxide indicator since carbon dioxide is produced as a result of respiration and the level of this gas from the lungs significantly exceeds that in atmospheric air and in gas from the oesophagus. Hence, a low level of carbon dioxide is indicative of incorrect intubation. Carbon dioxide levels can be monitored in a well-equipped hospital with a capnograph. Alternatively, an indicator formed from a calorimetric substance could be used, usually in the form of a treated paper strip. The indicator can be connected directly to the endotracheal tube or, as proposed in U.S. Pat. No. 4,790,327, it can be incorporated into the exhaust outlet of the resuscitator. Resuscitators of this kind are sold by Nellcor of California, USA under the name Indgo. It is desirable for such indicators to be highly visible and reliable in their response. Other patents describing carbon dioxide indicators used with resuscitators include U.S. Pat. No. 5,749,358 and U.S. Pat. No. 6,058,933.

Alternative resuscitators have a source of air or oxygen, such as from a compressed gas cylinder, connected to a mechanical valve and regulator arrangement by which the user can supply gas to the patient. An example of such a resuscitator is described in GB 2282542. It is also desirable with this form of resuscitator, where it is connected to an endotracheal tube to be able to check that the tube has been correctly positioned in the trachea. It can also be desirable to check that the patient is breathing correctly when a resuscitator is used with a face mask or a laryngeal mask.

BRIEF SUMMARY OF THE INVENTION

It is an object of the present invention to provide an alternative resuscitator, part of a resuscitator and an assembly

According to one aspect of the present invention there is provided a resuscitator having means for providing ventilation gas for a patient, a patient outlet for supplying the gas to the patient, an exhaust outlet for supplying exhaled gas from the patient to atmosphere, a diverter fitted on the exhaust outlet, the diverter including a diverter member inclined at an angle to the axis of the exhaust outlet, and an opening towards an end of the diverter member such that exhaled gas flowing through the exhaust outlet flows along an inner surface of the diverter member and out of the opening, the resuscitator including a colour-change carbon dioxide indicator mounted on the inner surface of the diverter member where it is exposed to flow through the diverter, and the indicator being visible externally of the diverter.

The diverter is preferably adjustable in orientation relative to the exhaust outlet and is preferably removable from the exhaust outlet. The diverter may be a push fit on the exhaust outlet. The diverter member is preferably of a transparent material. The resuscitator may include removable opaque means for protecting the indicator from light. The opaque means may include a removable strip of opaque material covering the exposed surface of the indicator internally of the deflector and the removable strip may have an end projecting beyond the opening of the diverter and may be arranged so that it can be removed by pulling on the end. The opaque means may include a strip of opaque material removably attached with and extending over an external surface of the diverter member. The external strip may be of an elastomeric material and may be attached with the diverter by means of engaging formations on the strip and the diverter. The resuscitator may include a squeeze bag of resilient material. The resuscitator may include a valve assembly having a tubular member extending within an outer housing and communicating with the patient outlet at one end and engaging a flexible diaphragm member at its other end by means of which flow of gas to the patient outlet and to the exhaust outlet is controlled, the tubular member being rotatable relative to the outer housing, and the tubular member being provided with a plurality of formations around its circumference arranged to allow a small amount of ventilation gas for supply to the patient via the tubular member to flow directly to the diverter regardless of the orientation of the tubular member.

According to another aspect of the present invention there is provided a diverter for a resuscitator according to the above one aspect of the invention.

According to a third aspect of the present invention there is provided an assembly of an endotracheal tube and a resuscitator according to the above one aspect of the invention with its patient outlet coupled with a machine end of the endotracheal tube.

An assembly of a squeeze-bag resuscitator, endotracheal tube and flow diverter, according to the present invention, will now be described, by way of example, with reference to the accompanying drawing.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference first toFIG. 1, the assembly includes a conventional endotracheal tube1, a squeeze-bag resuscitator2connected to the machine end of the tube and a flow diverter3connected on the exhaust outlet4of the resuscitator.

The patient end10of the endotracheal tube1is intended for placement in the trachea and has a cuff11towards its patient end that is inflatable via an inflation line12and connector13, so that it seals with the trachea. A connector14is fitted in the machine end15of the tube1.

The resuscitator2has a bulb-shape squeeze bag20of a resilient plastics material selected so that the bag can be squeezed by hand and recovers its original shape when released. At its lower end the resuscitator2has a one-way inlet valve21that allows air into the bag20when this is recovering its original shape but prevents flow of air out of the bag through the valve when the bag is squeezed. At its upper end the resuscitator2has a valve assembly22, which may be of the kind described in U.S. Pat. No. 4,774,941. The valve assembly22has a housing23of tubular shape in which the valve mechanism is housed and which is bonded at its lower end to the bag20. The upper end of the housing23has a lateral extension24projecting to one side, which provides a patient outlet. The patient outlet24is coupled to the connector14fitted into the endotracheal tube1. The exhaust outlet4projects laterally close to the lower end of the housing23in the form of a short, externally-tapered tubular port of circular cross section and 30 mm diameter. Inside the housing23the valve assembly22includes a conventional valve mechanism that opens the passage between the inside of the bag20and the patient outlet24when the bag is squeezed but blocks flow to the exhaust outlet4. When the bag20is released the valve mechanism prevents flow back into the bag but allows exhaled air from the patient to flow to the exhaust outlet4.

The flow diverter or deflector3is shown in greater detail inFIGS. 2,3and5. The deflector3is moulded of a transparent plastics material and has a main tubular portion30of circular section with a slight internal taper that is a push fit on the outside of the exhaust outlet4. A diverter member in the form of a deflector plate31extends from the upper end of the tubular portion30to one side. The plate31is curved at one end32where it joins with the main portion30, its other end33being straight and extending transversely of the main portion. The plate has curved side portions34, which join with the upper end of the main portion30. The plate31extends laterally across the major part of the width of the main portion30its right-hand, free end35being spaced forwardly of the end of the tubular portion30to provide an opening36of substantially segment shape extending across about half the width of the main portion. The diverter3also has knurled flange37extending around its upper end, which is enlarged towards the closed side of the diverter to form a small platform38. The platform38carries two locating fingers39of triangular shape at opposite ends and two upwardly-projecting pegs40adjacent respective ones of the locating fingers. The diverter3further has a small tongue41projecting forwardly from the free end35of the plate31.

The flow deflector3is used to divert the flow of exhaust gas away from the user. The need for this arises because, in the case of trauma, the exhaust gas may include aerosol dispersion of blood or other body fluids, which can present a hazard to the user. The user can fit the deflector3on the exhaust outlet4at any desired orientation. If he needs to change the position of the resuscitator2he can readily twist the deflector3around to a new position at which gas emerging from the outlet4is directed away from him.

The deflector3also includes a colour-change carbon dioxide indicator50(FIG. 6) in the form of a small square sheet of chemically treated material that changes color when exposed to gas containing carbon dioxide above a certain level. These kinds of indicator are sold by Bregas AB of Sweden. In particular, the indicator50has one color when exposed to normal atmospheric air and changes to a different colour when exposed to exhaled air containing elevated levels of carbon dioxide. The speed of response of the indicator50is sufficiently rapid that the indicator will change colour backwards and forwards between breaths. The indicator50is adhered to the inside surface of the curved part32of the deflector plate31so that it is exposed, directly in line with emerging gas flowing through the tubular portion30, which impinges on the exposed surface of the indicator. This ensures that the indicator50responds rapidly to changes in composition of the gas. Because the indicator50is mounted close to the end of the deflector and because the plate31is exposed around its end and sides, the indicator is exposed freely to atmospheric air, thereby ensuring that, when the flow of respiration gas ceases, it is quickly exposed to the atmospheric air to ensure a rapid change back to its low-carbon dioxide colour.

Before use, the indicator50is protected by a rectangular peel-off strip51attached with the indicator internally of the deflector and having a free end52projecting beyond the end35of the deflector plate31to provide a tab by which the strip can be gripped and pulled off the indicator, leaving the indicator in place. The peel-off strip51also has an oval hole53located about half way between its free end and the indicator50. The transparent nature of the deflector plate31enables the indicator50to be viewed through the plate so that its colour change is readily visible externally. Because the deflector3is oriented with its opening36away from the user, the indicator40is automatically oriented to face towards the user. The angle and curve of the deflector plate31further increase the range of angles over which the indicator is visible. Incorporating the indicator50in the flow deflector3ensures that there is no risk of the deflector obscuring an indicator such as might happen if the indicator were placed in the exhaust outlet itself.

Some colour-change indicators are sensitive to light and have to be protected during storage. In the present invention this is achieved by making the peel-off strip51covering the exposed surface of the indicator from an opaque material and by placing an additional, opaque, light-protecting strip60on the outside of the deflector plate31. The protecting strip60is shown inFIGS. 3 and 4and comprises a moulded strip of a flexible, opaque, elastomeric material. One end61of the strip60is thickened with a portion of triangular section and has two retaining apertures62through its thickness. The width of the strip60is such that it is a close fit between the two locating fingers39on the deflector with the pegs40extending in the retaining apertures62. The pegs40are slightly larger than the apertures62so that the strip has to be deformed slightly to accommodate the pegs and provides a secure retention of the strip. The strip60also has a small rectangular aperture63at a location about two thirds the way along its length from its thickened end and located to receive the tongue41so that the strip is held down across the plate31when the tongue is engaged in the aperture. The underside of the strip60also has a hooked projection64of oval shape located just forwardly of aperture63. The projection64is located to align with the hole53in the indicator peel-off strip51where this projects beyond the end35of the deflector plate. The projection64is slightly larger than the hole53so that it grips the peel-off strip51securely when pushed through the hole.

In this configuration, as shown inFIG. 3, the protecting strip60extends downwardly and forwardly beyond the free end35of the deflector plate31and is attached with the indicator peel-off strip51. The indicator50is protected from light during storage by the peel-off strip51on one side and by the protecting strip60on the other side.

To use, the free end of the protecting strip60is gripped and pulled up so that it pulls away from the tongue41and then from the pegs40. As it comes away, it pulls the peel-off strip51away from the indicator50, thereby exposing it to gas flow through the deflector30.

There are other ways in which the indicator could be protected from light. For example, an opaque dust cap could be fitted over the deflector before use to restrict the amount of light to which it was exposed.

As shown inFIG. 7, the indicator50′ could be located closer to the free end of the deflector plate31′ and be protected from light by an opaque U-section clip70′ shaped to fit over the free end of the deflector plate to cover the indicator on both sides. The clip70′ is retained in place on the diverter3′ by its resilience.

The response of the indicator to changes in carbon dioxide levels between inhaled and exhaled gas can be improved by allowing a small flow of fresh air into the resuscitator exhaust outlet to help flush out exhaled air containing elevated levels of carbon dioxide. This is preferably achieved in the manner shown inFIG. 8by modifying the resuscitator valve arrangement122to provide a small passage for air to flow from the interior of the squeeze bag120to the exhaust outlet104. Where the valve arrangement122has a flexible diaphragm valve124that engages the lower end of an inner tube125providing the patient outlet of the resuscitator, this may be done simply by forming a small hole through the inner tube in alignment with the exhaust outlet104. Alternatively, as shown inFIG. 8, the lower end126of the inner tube125may be provided with a formation, such as a V-shape groove127or other notch aligned with the exhaust outlet104, which allows some of the fresh air supplied to the inner tube125by the squeeze bag120to escape to the exhaust outlet104and flush out any residual exhaled air having elevated levels of carbon dioxide. Where the inner tube125is rotatable relative to the valve housing123, it preferably has several grooves127or similar formations around its circumference, as shown inFIG. 8, so that at least one of these is substantially aligned with the exhaust outlet104regardless of the orientation of the inner tube.

The deflector is not confined to use with squeeze bag resuscitators but could be used with other resuscitators having an exhaust outlet.