Title of Invention

A PRESSURE REGULATING DEVICE FOR REGULATING THE PRESSURE DELIVERED BY A BREATHING ASSISTANCE APPARATUS AND A BREATHING ASSISTANCE APPARATUS THEREOF

Abstract

A pressure regulating device (134) for use with a breathing assistance apparatus which conveys gases to a patient requiring breathing assistance. Traditionally pressure relief valves for Breathing Assistance Apparatus require high quality springs in the pressure relief valve to ensure that the pressure at which the valve operates is consistent. The device includes a valve member (146) disposed within a valve housing (148) which when gases flowing through the regulator reach a predetermined level at least a portion of the gases are permitted to flow through a vent aperture (169) externally, similar to known pressure relief valves. The present invention includes an adjustment mechanism (150) engaged with the valve member (146) and for adjusting the predetermined level, and a locking mechanism (154) for permanently preventing access to the adjustment mechanism (150) once the predetermined level has been factory set.

Full Text

2 FIELD OF THE INVENTION The present invention relates to----a pressure regulating device for regulating the pressure delivered by a breathing assistance apparatus.More particularly though not solely, it relates to regulating the pressure of gases supplied to a patient from a humidified Positive End Expiratory Pressure (PEEP) apparatus. BACKGROUND ART At the moment of their first breath, a baby's lungs are collapsed and filled with fluid. The pressures needed to open such lungs, and keep them open, are several times that of a normal breath until the fluid is displaced and the lungs have filled with air. To generate these large pressures, the baby must have strong respiratory muscles, as well as a chemical called surfactant in their alveoli. Surfactant reduces the surface tension of the fluid within the alveoli, preventing the alveolar walls from sticking to each other, like coasters to coffee cups when there is water between them. Neonates have difficulty in opening their lungs and keeping them open. Reasons for this include: a) Weak respiratory muscles and low surfactant levels. This means that they cannot generate enough pressure to open the lungs and, should they be resuscitated, tire quickly with the effort of keeping open alveoli lacking in surfactant. b) Underdeveloped internal tissue structure to support the alveoli. c) Slower clearance of lung fluid. In very premature neonates, fluid may continue to be secreted in the alveoli even after birth. d) A soft chest wall, horizontal ribs, and a flatter diaphragm contribute to reduce the inspiratory capacity. e) The mixing of oxygenated and deoxygenated blood raises blood pressure in the lungs, increasing fluid movement from the blood vessels into the lung tissue. The reduced blood oxygen level starves tissue of oxygen and further weakens respiratory muscles. f) Weak neck muscles and a lack of neck fat reduce upper airway stability so that collapse on inspiration may occur. g) Collapsed, damaged alveoli secrete proteins that reduce surfactant function. To alleviate this it is know to apply positive end expiratory pressure (PEEP) during respiration. In applying PEEP, the neonate's upper airway and lungs are held open during inspiration, while expiration occurs against a pressure that stops alveolar collapse. Lung fluid is pushed back into the circulating blood, alveolar surfactant is conserved, and a larger area of the lung participates in gas exchange with the blood. As blood oxygenation and carbon dioxide removal improves, more oxygen is delivered to growing tissues, while less oxygen and energy is consumed by respiratory muscles. PEEP therapy is known to cause lung rupture (or pneumothorax) in 0-30% of nasally ventilated neonates with air embolism in the vasculature also known to occur. It was originally thought that air would leak out of the mouth should pressures become 3 to high, and therefore the cause of the ruptures was unclear. Perhaps chin-straps, which are used to stop mouth leak and pressure loss, were used on those neonates who later developed pneumothoraces. Alternatively, it may be that mouth leak never occurs, even under high pressures, because the neonates are obligatory nose-breathers. To avoid such side effects it is thought desirable in the art to provide a pressure relief valve as a safety device to prevent the pressure rising above a maximum safe level. Accordingly it is well known in the art to use a spring biased valve which actuates at a level of pressure deemed the maximum permissible to allow the gases to vent externally. This in turn requires the use of high quality springs which have been individually tested to give a high tolerance spring constant in order to ensure that it actuates at a value substantially that of the maximum safe pressure. Both the manufacture and testing of such a spring necessitates that its cost will be correspondingly high. Accordingly it would be advantageous to provide a pressure relief valve for a breathing assistance system which did not involve the use of such a high tolerance spring. For example in United States Patent number 4515179 a pressure relief valve including a housing defining an internal valve chamber is described. A valve seat is positioned within the chamber, and a valve pallet is reciprocally mounted within the chamber to engage the seat in a valve closed mode. A spring is mounted with in the housing to bias the valve pallet into engagement with the valve seat. A spring retainer is threaded through an aperture in the housing and extends into the valve chamber. The spring is located with in the retainer. A desired set pressure to be imposed upon the valve pallet is provided by threading the retainer relative to the housing thereby compressing the springs. To lock the retainer relative to the housing an annular lock member is threaded onto the outside of the retainer. Once the desired set pressure is attained, the lock member is threaded on the retainer until it abuts the housing . The lock member includes first and second ends spaced apart to define a gap. A fastener is threaded into the first and second ends across the gap and maybe tightened to narrow the gap and set the lock member onto the retainer. The retain is then locked relative to the housing by a jamming screw threaded through the lock member into engagement with housing . To provide better control of the spring an alternative retainer may be employed. The alternative retained includes a pair of telescoping tubes with the spring positioned with in the tubes. A first tube of the pair extends through and is threaded in a bushing mounted in an aperture in the valve housing. A second tube is connected by a gimbal mounting to the valve pallet. An alternative lock member may be secured to the retain by a radial fastener. In United States Patent number 5664447 a lockout device is disclosed to prevent tampering with the manually set position of a valve or regulating or other 4 device having a rotatable shaft for adjusting, for example, the flow of fluid through the device, from a position initially set to some other position. The lockout device is usable with a wide range of standard valves and regulators which have a drive stem and includes a drive gear that engages the drive sten and a key locking device mounted in a generally cylindrical handle of the lockout device and being selectively movable from first position in which the handle free-wheels relative to the drive stem of the valve so as to prevent unauthorized moving of the rotational position of the valve stem by any person not having a key to an engaging position in which the handle is locked to the drive stem to permit ordinary rotational movement and setting of the valve stem position. In United States Patent Number 5950623 an adjustable pressure limiting valve having a non-linear biasing means is described. The valve has a movable valve member that can be moved to an open position by a predetermined pressure and a closed position on a valve seat. A rotating control knob is rotated by the use to adjust the bias acting against the movable valve member toward the closed position to, in turn, set the pressure at which the valve opens. A rotating cylindrical drum rotates along with the control knob and has a helical groove formed in its exterior and a pair of fixed pins that ride in the helical groove. When the cylindrical drum is rotated, the fixed pins riding in the helical grove cause the cylindrical drum to move along its longitudinal axis to compress or decompress a spring acting against the movable valve member. The relationship between the rotational movement of the control knob and the longitudinal movement of the cylindrical drum. SUMMARY OF THE INVENTION It is an object of the present invention to provide a pressure regulator which goes some way to overcoming the above-mentioned disadvantages, or which will at least provide the Healthcare industry with a useful choice. Accordingly,--------the present invention provides a pressure regulating device for regulating the pressure delivered by a breathing assistance apparatus which conveys gases to a patient requiring breathing assistance, comprising: housing means comprising an inlet and an outlet and a venting aperture, in use said inlet and outlet being in fluid communication or integrated with a breathing apparatus, a valve member disposed within said housing means, in the flow path between said inlet and said outlet, wherein the pressure of gases flowing from said inlet to said outlet being below a predetermined level said valve member blocking said vent aperture and said gases thereby flowing from said inlet to said outlet, and wherein said gases being above said predetermined level said valve member allowing at least a portion of said gases to flow through said vent aperture, adjustment means engaged with said valve member and adapted to adjust said predetermined level, and 5 adjustment locking means adapted to engage with or about said adjustment means, such that with said adjustment locking means engaged said predetermined level is permanently prevented from adjustment, is tamper evident and covers said adjustment from external observation. Preferably said valve means comprises a valve housing, a valve member and a restraining means, wherein said pressure of gases flowing from said inlet to said outlet being below said predetermined level said restraining means biasing said valve member against said vent aperture thereby blocking said vent aperture, and wherein the pressure of said gases being above said predetermined level said restraining means biasing said valve member to a position to allow at least a portion of said gases through said vent aperture. More preferably said restraining means comprises a helical spring. Preferably said adjustment means comprises a rotatable cap engaged, with at least said helical spring and adapted such that in use the rotation of said cap varies the compression of said restraining means thereby changing said predetermined level. Preferably said adjustment locking means comprises a locking cap adapted to prevent external access to and prevent from further rotation of, said rotatable cap. The present invention also provides a breathing assistance apparatus for supplying gases to a patient to assist said patient's breathing comprising: a gas supply adapted to supply gases to said patient, delivery means including a plurality of ports adapted to deliver said flow of gases to said patient, inhalatory gases transport means for conveying said gases from said gases supply means to said delivery means, and a pressure regulating device disposed within or in fluid communication with said inhalatory gases transport means, said pressure regulating device comprising: housing means comprising an inlet and an outlet and a venting aperture, in use said inlet and outlet being in fluid communication or integrated with said inhalatory gases transport means, a valve member disposed within said housing, in the flow path between said inlet and said outlet, wherein the pressure of gases flowing from said inlet to said outlet being below a predetermined level said valve member blocking said vent aperture and said gases thereby flowing from said inlet to said outlet, and wherein said gases being above said predetermined level said valve member allowing at least a portion of said gases to flow through said vent aperture, adjustment means engaged with said valve member and adapted to adjust said predetermined level, and adjustment locking means adapted to engage with or about said adjustment means, and adapted such that with said adjustment locking means engaged said predetermined level is prevented from adjustment, is tamper evident and covers said adjustment from external observation. 6 Preferably said apparatus comprises humidification means disposed within or in fluid communication with said gases supply means, said inhalatory gases transport means and said delivery means, thereby humidifying said gases. The present invention also provides a method of manufacturing a system for regulating the pressure of gases supplied to a patient to assist said patients breathing comprising the steps: assembling a valve and configuring said valve to in use relieve the pressure of said gases substantially at a predetermined pressure, adjusting said predetermined pressure to a desired pressure, and preventing further adjustment such that said predetermined pressure is permanently set. To those skilled in the art to which the invention relates, many changes in construction and widely differing embodiments and applications of the invention will suggest themselves without departing from the scope of the invention as defined in the appended claims. The disclosures and the descriptions herein are purely illustrative and are not intended to be in any sense limiting. The invention consists in the foregoing and also envisages constructions of which the following gives examples. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS One preferred form of the present invention will now be described with reference to the accompanying drawings in which: Figure 1 is a block diagram showing a typical configuration for supplying breathing assistance to a patient, Figure 2 is a blown out view of the pressure regulator with the lid on according to the preferred embodiment of the present invention, and Figure 3 is a blown out cross section of the pressure regulator according to the preferred embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention provides a means of regulating the pressure of gases supplied to a patient connected to a positive pressure ventilation device to a maximum safe level. By providing an adjustable pressure relief valve the need for an expensive spring is avoided. The adjustment is made during manufacture and the mechanism disabled to prevent further adjustment. Referring now to Figure 1 in which a typical application is depicted. A humidified Positive End Expiratory Pressure (PEEP) system is shown in which a patient 119 is receiving humidified and pressurised gases through a nasal mask 128 (or nasal cannula) connected to a inhalatory conduit 121. It should be understood that the present invention, however, is not limited to the delivery of PEEP gases but is also applicable to other types of gases delivery systems and may not necessarily involve humidification. Inhalatory conduit 121 is connected to the outlet 112 of a 7 humidification chamber 110 which contains a volume of water 115. Inspiratory conduit 121 may contain heating means or heater wires 118 which heat the walls of the conduit to ensure a constant humidity profile along the conduit and therefore reduce condensation of humidified gases within the conduit, As the volume of water 115 within humidification chamber 110 is heated, water vapour begins to fill the volume of the chamber above the water's surface and is passed out of the humidification chamber 110 outlet 112 with the flow of gases (for example air) provided from a gases supply means 118 which enters the chamber 110 through inlet 116. The humidified gases pass through the inhalatory conduit 121 to the mask 128 (or nasal cannula) attached around the patient's 119 face. The excess gases then flow through the exhaiatory conduit 130 to a column of water 140 which regulates the mean pressure level. Pressure Regulator In the preferred embodiment of the present invention the pressure regulator 134, is shown in Figures 2 and 3 in detail. The regulator 134 includes a manifold housing 136 with an inlet 138 and an outlet 140. In the preferred embodiment the regulator 134 is disposed in the breathing circuit between the blower 118 and the humidifier 114. The regulator 134 may either be supported by mounting bracket 162 or connected directly to humidifier inlet 116. The regulator inlet 138 is purposely a different size to outlet 140 to avoid it being connected incorrectly. Also provided are oxygen port 64, and sensor ports 166, 168 which are blocked if not in use- The manifold housing 136 includes a hollow internal cavity running from the inlet 138 to the outlet 140. Also in fluid communication with the internal cavity 142 is a vent aperture 144 which includes a cambered surface around its periphery which acts as a valve seat for the valve plunger 146. Attached around the outside of the vent aperture 144 is the valve housing 148 which substantially in use houses the valve plunger 146. To hold the valve plunger 146 in place within the valve housing 148 the adjustment cap 150 fits over top of the valve plunger 146 and engages with the valve housing 148. Rotation of the adjustment cap 150 about a helical thread 170 on the valve housing 148 either further compresses or expands a helical valve spring 152 which provides the restraining force on the valve plunger 146. Therefore by rotation of the adjusting cap 150 during manufacture and testing the pressure at which the valve opens can be adjusted to a desired value. The adjustment cap 150 also includes a guide channel 151 to house and guide the shaft of the plunger 146, A vent outlet 169 is provided on the housing 148 to vent the overpressure gases externally. In use it is ushered by both these caps, ensuring nothing can be introduced to obstruct the valve operation. Once the spring has been adjusted to the desired level it may be locked in place 8 by attaching the locking cap 154 in place over top of the adjustable cap. The locking cap 154 slides on top of the adjusting cap 150 and engages with it by virtue of a plurality of locking splines 156 disposed on its inner periphery which engage with a lesser number of locking splines 158 disposed on the outer periphery of the adjusting cap 150. Further the locking cap snaps into place and is permanently held over the valve housing 148 by virtue of the locking lip 159 which engages with the lowermost portion and locking clips 161 for the locking cap 154. Certain of the locking splines 157 on the inner periphery of the locking cap 154 extend the full length of its inner periphery to engage both the adjusting cap splines 158 as well as splines 160 on the outer periphery of the valve housing 148 to prevent any rotation. In this fashion the adjusting cap 150 is prevented from further rotation as well as prevented from any external access. Once adjusted to the desired pressure during manufacture and testing the valve is permanently set at that pressure and may not be adjusted once locked in place. The cap 150 might be marked "Do not remove" for example, and the locking clips 161 could be purposely weakened such that removal will destroy the valve. This avoids the need to have a high tolerance spring as a spring within a relatively wider range may be adjusted to give the desired pressure. 9 WE CLAIM: 1. A pressure regulating device for regulating the pressure delivered by a breathing assistance apparatus which conveys gases to a patient requiring breathing assistance, comprising: housing means comprising an inlet and an outlet and a venting aperture, in use said inlet and outlet being in fluid communication or integrated with a breathing apparatus, a valve member disposed within said housing means, in the flow path between said inlet and said outlet, wherein the pressure of gases flowing from said inlet to said outlet being below a predetermined level said valve member blocking said vent aperture and said gases thereby flowing from said inlet to said outlet, and wherein said gases being above said predetermined level said valve member allowing at least a portion of said gases to flow through said vent aperture, adjustment means engaged with said valve member and adapted to adjust said predetermined level, and adjustment locking means adapted to engage with or about said adjustment means, and adapted, such that with said adjustment locking means engaged said predetermined level is permanently prevented from adjustment, is tamper evident and covers said adjustment from external observation. 2. A pressure regulating device as claimed in claim 1 wherein said valve means comprises a valve housing, a valve member and a restraining means, wherein said pressure of gases flowing from said inlet to said outlet being below said predetermined level said restraining means biasing said valve member against said vent aperture thereby blocking said vent aperture, and wherein the pressure of said gases being above said predetermined level said restraining means biasing said valve member to a position to allow at least a portion of said gases through said vent aperture. 3. A pressure regulating device as claimed in claim 2 where in said restraining means comprises a helical spring. 4. A pressure regulating device as claimed in claim 3 wherein said adjustment means comprises a rotatable cap engaged with at least said helical spring and adapted such that in use the rotation of said cap varies the compression of said restraining means thereby changing said predetermined level. 5. A pressure regulating device as claimed in claim 4 wherein said adjustment locking means comprises a locking cap adapted to prevent external access to and prevent further rotation of, said rotatable cap. 6. A breathing assistance apparatus for supplying gases to a patient to assist said patient's breathing comprising: a gases supply adapted to supply gases to said patient, delivery means comprising a plurality of ports adapted to deliver said flow of gases to said patient, inhalatory gases transport means for conveying said gases from said gases supply means to said delivery means, and a pressure regulating device disposed within or in fluid communication with said inhalatory gases transport means, said pressure 6. 10 regulating device comprising: housing means comprising an inlet and an outlet and a venting aperture, in use said inlet and outlet being in fluid communication or integrated with said inhalatory gases transport means, a valve member disposed within said housing, in the flow path between said inlet and said outlet, wherein the pressure of gases flowing from said inlet to said outlet being below a predetermined level said valve member blocking said vent aperture and said gases thereby flowing from said inlet to said outlet, and wherein said gases being above said predetermined level said valve member allowing at least a portion of said gases to flow through said vent aperture, adjustment means engaged with said valve member and adapted to adjust said predetermined level, and adjustment locking means adapted to engage with or about said adjustment means, and adapted, such that with said adjustment locking means engaged said predetermined level is prevented from adjustment, is tamper evident and covers said adjustment from external observation. 7. A breathing assistance apparatus as claimed in claim 6 wherein said apparatus comprises humidification means disposed within or in fluid communication with said gases supply means, said inhalatory gases transport means and said delivery means, thereby humidifying said gases. 8. A method of manufacturing a system for regulating the pressure of gases supplied to a patient to assist said patients breathing comprising the steps: assembling a valve and configuring said valve to in use relieve the pressure of said gases substantially at a predetermined pressure, adjusting said predetermined pressure to a desired pressure, and preventing further adjustment such that said predetermined pressure is permanently set. 9. A method of manufacturing a system for regulating the pressure of gases supplied to a patient to assist said patients breathing comprising the steps as claimed in claim 8 and also comprising the steps of preventing external observation of said valve. 10. A method of manufacturing a system for regulating the pressure of gases supplied to a patient to assist said patient's breathing comprising the steps as claimed in claim 9 and also comprising the steps of preventing tampering by said patient. A pressure regulating device (134) for use with a breathing assistance apparatus which conveys gases to a patient requiring breathing assistance. Traditionally pressure relief valves for Breathing Assistance Apparatus require high quality springs in the pressure relief valve to ensure that the pressure at which the valve operates is consistent. The device includes a valve member (146) disposed within a valve housing (148) which when gases flowing through the regulator reach a predetermined level at least a portion of the gases are permitted to flow through a vent aperture (169) externally, similar to known pressure relief valves. The present invention includes an adjustment mechanism (150) engaged with the valve member (146) and for adjusting the predetermined level, and a locking mechanism (154) for permanently preventing access to the adjustment mechanism (150) once the predetermined level has been factory set.

Documents:

00053-cal-2002-abstract.pdf

00053-cal-2002-claims.pdf

00053-cal-2002-correspondence.pdf

00053-cal-2002-description(complete).pdf

00053-cal-2002-drawings.pdf

00053-cal-2002-form-1.pdf

00053-cal-2002-form-19.pdf

00053-cal-2002-form-2.pdf

00053-cal-2002-form-3.pdf

00053-cal-2002-form-5.pdf

00053-cal-2002-g.p.a.pdf

00053-cal-2002-priority document.pdf

53-CAL-2002-(26-09-2012)-CORRESPONDENCE.pdf

53-CAL-2002-(26-09-2012)-OTHERS.pdf

53-CAL-2002-CORRESPONDENCE 1.1.pdf

53-CAL-2002-FORM 15.pdf

53-CAL-2002-FORM-27.pdf

53-cal-2002-granted-abstract.pdf

53-cal-2002-granted-assignment.pdf

53-cal-2002-granted-claims.pdf

53-cal-2002-granted-correspondence.pdf

53-cal-2002-granted-description (complete).pdf

53-cal-2002-granted-drawings.pdf

53-cal-2002-granted-examination report.pdf

53-cal-2002-granted-form 1.pdf

53-cal-2002-granted-form 19.pdf

53-cal-2002-granted-form 2.pdf

53-cal-2002-granted-form 3.pdf

53-cal-2002-granted-form 5.pdf

53-cal-2002-granted-gpa.pdf

53-cal-2002-granted-letter patent.pdf

53-cal-2002-granted-reply to examination report.pdf

53-cal-2002-granted-specification.pdf

53-cal-2002-granted-translated copy of priority document.pdf

53-CAL-2002-OTHERS 1.1.pdf