NL2001943C

NL2001943C - Respiration aid and method.

Info

Publication number: NL2001943C
Application number: NL2001943A
Authority: NL
Inventors: Gerardus Wilhelmus Lugtigheid
Original assignee: Emergency Pulmonary Care B V
Priority date: 2008-09-01
Filing date: 2008-09-01
Publication date: 2010-03-11
Also published as: WO2010024680A1

Description

P84855NL00

Title: Respiration aid and method

The invention concerns a respiration aid for administering gas to a patient, comprising a gas container, a gas inlet for allowing gas to enter into the container, and a gas outlet for allowing gas to be released from the container for administration to a patient.

5 The invention also concerns a method for administering gas to a dummy or test person using a respiration aid.

The invention furthermore concerns a method for administering gas to a patient using a respiration aid.

Respiration apparatuses are known from practice and usually comprise 10 a balloon unit, provided with an inlet valve, for allowing ambient air into the balloon unit, and provided with a respiration channel for connection with a patient to whom artificial respiration is to be applied, which respiration channel is provided with a check valve for allowing ambient air to flow from the balloon unit via the respiration channel to the patient upon squeezing the 15 balloon unit, and which respiration channel is further provided with an evacuation valve, which at rest is held in an open position by the action of a spring, for evacuating air exhaled by the patient via the respiration channel to the environment. The respiration channel may be connected to a face mask, which is preferably provided over the mouth and nose of the patient using 20 bands or elastic straps. Alternatively the respiration channel may be connected to a tube which is inserted into the airway, such as a laryngeal mask. An air tight connection is required between the patient and the face mask and/or the inserted tube in order to prevent leakage of the displaced air to the environment. Additional tubing may be provided between the 25 respiration channel and the face mask or inserted tube, allowing the bellows to be placed at a distance from the mouth and nose of the patient. Usually, the balloon unit comprises a resilient bellows. Upon manually squeezing the bellows from a starting position, the pressure in the bellows is increased and a 2 volume of air enclosed by the bellows is displaced from the bellows via the check valve through the respiration channel to the patient. The increased pressure in the respiration channel forces the evacuation valve against the action of the spring in a closed position. Upon releasing the bellows, it 5 rebounds to the starting position, closing the check valve while allowing ambient air to be sucked in via the inlet valve. As a result of the reduced pressure in the respiration channel, the spring force induces the evacuation valve to return to an open position, allowing the exhaled air to flow from the patient to the environment.

10 Such a manually operated respiration apparatus is known to a skilled person by the name of resuscitator and is used for manually applying artificial respiration to persons or animals, for instance during reanimation. Such a respiration apparatus has a simple construction and can easily be transported. Further, the apparatus has a high reliability, while a minimum of 15 maintenance is required.

Operation of balloon units requires experience and delicate handling. In stress situations, even trained professionals may have difficulties in applying the appropriate force on a balloon unit during manual ventilation. As a result the operator may squeeze the balloon too hard, inflating the lungs of the 20 patient with too much air and/or pressure, which can be dangerous. On the other hand, squeezing the balloon too gently may have little effect on inflation of the lungs.

A known respiration aid that has tried to solve this problem is disclosed in international patent application W02005/Q21074. Here, a manually 25 operated respiration apparatus comprising a balloon is described, wherein the balloon is mounted with an overpressure protection, to prevent too much pressure being built up in a patient’s lungs.

With such known respiration apparatuses, however it may still be difficult to administer an appropriate volume of gas. For example, the 30 operator’s fingers may squeeze the balloon relatively unevenly, especially 3 when the operator is relatively inexperienced. Such known respiration apparatuses are not normally available to laymen having no more than Basic Life Support (BLS) qualification and skills, whereas the main concern of these laymen when involved in a resuscitation attempt is the risk of infection during 5 mouth-to-mouth resuscitation. Furthermore such known respiration apparatuses have no integrated PEEP function, which is for example required for resuscitation of a drowning person or a neonate with meconium aspiration.

A goal of the invention is therefore to provide for an alternative respiration aid that may solve at least one of the above disadvantages.

10 This goal and/or other goals may be reached by a respiration aid according to claim 1.

It has been found that by providing a respiration aid with two relatively rigid walls, connected by a pliable wall, the volume of gas being administered can be controlled in a better way. By pressing the two rigid walls 15 towards each other a continuous and relatively even gas release can be obtained, allowing for a better dosing of the volume of gas being administered.

This goal and/or other goals may also be achieved by a method according to claim 15.

In clarification of the invention, further embodiments of the 20 invention, and advantages thereof will be further elucidated in the claims and description, with reference to the drawings. In the drawings:

Fig. 1 shows a schematic top view of a respiration aid according to the invention;

Fig. 2 shows a schematic cross-sectional side view of a respiration 25 aid according to the invention;

Fig. 3 shows a schematic top view of another embodiment of a respiration aid according to the invention.

Fig. 4A shows a schematic perspective view of a respiration aid in open condition; 4

Fig. 4B shows a schematic perspective view of the respiration aid of Fig. 4A in closed condition;

Fig. 4C shows a side view in detail of the feet shown in Fig. 4B.

Fig 5 shows a schematic cross-sectional side view of a 5 nonrebreathing valve assembly having a predetermined PEEP function.

In this description, identical or corresponding areas have identical or corresponding reference numerals. The exemplary embodiments shown should not be construed to be limitative in any manner and serve merely as illustration. Any dimensions or relative dimensions may not be taken from the 10 drawings.

In Fig. 1, a respiration aid 1 for administering a gas, preferably ambient air, to a patient is shown. Gas may be administered to a human or animal patient. The aid 1 comprises a container 2 that is formed by walls 3, 4, 5, more particularly two relatively rigid walls 3, 4, and a relatively pliable wall 15 5 that is connected with said rigid walls 3, 4, functioning as a pump. A joint, preferably a flexible joint 6, may be connected to the rigid walls 3, 4, and serve as a hinge. For example, the rigid walls 3, 4 may hinge about a pivot axis H.

In use, the container 2 is filled with air, at least when the rigid walls 3, 4 are separated. The rigid walls 3, 4 may extend opposite each other, and 20 may be substantially flat. The inner volume of the container 2 may be arranged between the rigid walls 3, 4 so that the volume may be compressed by the rigid walls 3, 4. When the rigid walls 3, 4, are moved towards each other the gas is pressed through a gas outlet 7A, and through a patient connector 8, for administration to a patient. In this description, a patient may be 25 understood as being a person or animal. The respiration aid 1 may also be applied to test dummies or test persons so that operators may practise using respiration aid 1.

The outlet 7A may for example be provided near the pivoting axis P, or in either of the rigid walls 3, 4, or in the pliable wall 5. The outlet 7A may 30 be provided between the flexible joint 6 and the opposing pliable wall 5, 5 preferably centrally between the flexible joint 6 and the opposing pliable wall 5, more preferably at the centre of the perpendicular P between the flexible joint 6 and opposing pliable wall 5.

After an operator has moved the rigid walls 3, 4 towards each other, 5 the rigid walls 3,4 may automatically move back in a position distanced from each other to allow ambient air to fill the container 2, due to evening of the pressure in the container 2 with respect to the ambient pressure. In another embodiment, a resilient element may be connected to both rigid walls 3, 4, that may be biased so that the rigid walls 3, 4 will be separated from each other.

10 This resilient element could for example be integrated with the joint 6. For example, the flexible joint 6 may be provided as a resilient material, providing the spring bias to separate the rigid walls 3, 4. Alternatively, a coiled spring (not shown) maybe provided that is connected to the rigid walls 3, 4, preferably to the centre thereof. In an embodiment, the bias of the resilient 15 element is independent of the position of the rigid walls 3, 4 with respect to each other, so that the force required to move the rigid walls 3, 4 towards each other may be relatively uniform during the entire movement.

The pliable wall 5 may for example be bellows shaped. The pliable wall 5 may comprise relatively flexible material. In an embodiment, the pliable 20 wall 5 may for example be a pliable bag that is connected between two rigid walls 3, 4. In an embodiment, the pliable wall 5 may be arranged so that it is prevented that it juts out from between the rigid walls 3, 4, when the rigid walls 3, 4 are pressed together.

The container .2 may have a gas inlet 7 for allowing gas, preferably 25 ambient air, to enter into the container 2. The inlet 7 may for example be provided in, on or near the rigid walls 3, 4. For example, when the pressure in the container 2 is low relative to the ambient pressure outside of the container 2, the inlet valve 7 may allow the pressure in the container 2 to become approximately equal to the ambient pressure by allowing air to pass through 30 the inlet valve 7, to the inside of the container 2.

6

Preferably, the inlet 7 also comprises a safety valve. In an embodiment, the inlet valve 7 is a two-way safety valve. In another embodiment, a safety valve may be provided as a separate valve from the inlet valve 7. The integrated or separate safety valve may also be known in the field 5 as pressure safety valve or pressure relief valve, for example. The safety valve may prevent the patient’s lungs from being inflated with too much air, for example when the rigid walls 3, 4 are pressed to hard and/or too fast, which could damage the patient. The safety valve is arranged to release some of the pressurised air from the container 2, if the pressure in the container 2 is too 10 high, for example due to resistance in the lungs of the patient . Meanwhile , the In rigs of the patient may still be ventilated through the gas outlet 7A, at a more convenient pressure. The maximum threshold pressure for releasing air from the container 2 may for example be predetermined by the characteristics of the safety valve that is provided in the respiration aid 1. Preferred safety 15 valves may be selected according to the purpose of the respiration aid 1. In an exemplary embodiment, the maximum pressure may for example be set to a value between 15 and 80 hPa (hectoPascal), preferably approximately 35 hPa. A safety valve and/or maximum pressure may for example be selected by consulting the guidelines of the American Heart Association and/or European 20 Resuscitation Council, for example when the respiration aid 1 is used in combination with an AED (automatic electronic defibrillator). In another embodiment, the ATLS (Advanced Trauma Life Support) guidelines may be consulted, for example for alternative uses. Different safety valves or safety valve settings may be marked with colour codes.

25 The outlet 7A may be connected to a patient connector 8, for administering air to the patient, which may comprise an ISO 22/15 connector. The patient connector 8 may be connected to a face mask (not shown), which in use may be provided over the mouth and nose of the patient using bands or elastic straps. Alternatively the patient connector 8 may be connected to a tube 30 which is inserted into the airway, such as a laryngeal mask. The patient 7 connector 8 may for example comprise a nonrebreathing valve assembly 16 having a predetermined PEEP function (see Fig. 5). In an embodiment, an extension tube 9 is provided between the gas outlet 7A and the patient connector 8 (Fig. 3). This may allow the patient connector 8 to be positioned at 5 a distance from the container 2. Preferably the extension tube 9 is relatively flexible, or at least relatively bendable. The tube 9 may comprise a hose and may be at least approximately 0,5 metres in length, preferably approximately 0,6 metres. The diameter of the tube 9 may for example be at least approximately 10 millimetres, preferably at least approximately 20 10 millimetres, more preferably approximately 22 millimetres. The tube 9 may be connected to the respiration aid 1 using standard connectors.

The respiration aid 1 may comprise a spacer arrangement for setting a minimum distance between the two relatively rigid walls 3, 4. This may prevent that the rigid walls 3, 4 are pushed too close together, which in turn 15 may prevent that the patient is inflated with too much air. The spacer arrangement may for example comprise one or more spacers 10. The spacers 10 may for example be arranged at the inside of the container 2, for example as protrusions extending from at least one of the rigid walls 3, 4 in the direction of the opposite rigid wall 4, 3.

20 In an embodiment, the respiration aid 1 is a manual respiration aid 1 for administering gas to a patient by squeezing gas from the container 2. Preferably, the respiration aid 1 has such dimensions that it can be operated using a single normal hand. The normal force that is needed to squeeze the rigid walls 3, 4 together during manual respiration can be approximately 120 25 N (Newton). This force can be applied with a normal single hand, for example an average sized hand of an adult person, more preferably with the fingers of such hand. In particular the respiration aid 1 may be operated by just the finger tips of a normal hand. Alternatively the respiration aid 1 may be placed sideways on the floor and be operated by the ball of one hand or even a 30 clenched fist. The safety valve may in that case prevent inflation of the lungs 8 of the patient with too much air and/or pressure. When a resilient element is connected to both rigid walls 3, 4, for example a resilient flexible joint 6, the resilient force is preferably uniform over the entire range of movement of the rigid walls 3, 4, so that the pressure and volume of the gas that is 5 administered to the patient becomes essentially independent of the skills and experience of the user.

For example, in a state wherein the rigid walls 3, 4 extend at a maximum distance from each other, the container 2 may for example have a volume of approximately between 0,1 and four litres, wherein the volume is 10 defined by the space that is formed between the walls 3, 4, 5 and the joint 6. In an exemplary embodiment, the maximum volume may be between 0,2 and 1,5 litres, preferably approximately 0,65 litres. The respiration aid may be provided with a scale indicating the actual volume displaced to the patient as an absolute value or a percentage of the maximum volume. The respiration aid 15 may furthermore be provided with a printed table displaying the normal inspiratory volumes for an adult, adolescent, child and neonate. This may enable a less experienced user to learn proper operation of the respiration aid for all these patient categories.

In an embodiment the respiration aid 1 is provided with a connector 20 for supplying oxygen, for example from a low pressure oxygen reservoir. This may allow professional users to manually ventilate a patient with air that is enriched with oxygen.

In an embodiment the respiration aid 1 is provided with a bacterial filter, for example between the container 2 and the patient connector 8.

25 Operation of the respiration aid 1 by a relatively inexperienced user may be relatively safe. The respiration aid 1 may provide for controlled dosing of the gas to be administered to the patient. Said safety valve and/or the spacer arrangement may prevent the inflation of a patient’s lung with too much air. Because of the added safety elements, the risk of an inexperienced user 9 harming the patient is reduced, and training for application of the respiration aid 1 may not be needed, or just a basic training may be required.

An embodiment of the respiration aid 1 for an adult is shown in Fig. 4A - 4C. The respiration aid 1 comprises two rigid walls 3, 4, connected to a 5 flexible joint 6, and a pliable wall 5. Opposite the joint 6, the walls 3, 4 may be provided with feet 10,11. The pliable wall 5 extending between the rigid walls 3, 4 may comprise a bellows, and may be manufactured from flexible material such as rubber. Note that the bellows are shown for illustrative purposes. The actual shape of the bellows may be different.

10 In an open condition, as shown in Fig. 4A, a width w of the respiration aid 1 may be defined by the distance between the ends of the rigid walls 3, 4, more particularly the ends of the feet 9, 10, respectively. The width 2 may for example be approximately 160 millimetres. A height h of the respiration aid 1 may for example be approximately 120 millimetres, in open 15 condition, wherein the height h may be defined as the length of a perpendicular line between the top of the joint and a line between the ends of the rigid walls 3, 4, more particularly a line between the ends of the feet 10, 11. A length 1 of the rigid walls 3, 4 may for example be approximately 150 millimetres, wherein the length 1 may be defined as the length of the rigid 20 walls 3, 4, and/or the length of the joint 6. For the respiration aid 1 to be manually operated relatively conveniently, the length 1, width w and/or height h may for example be less than approximately 250 millimetres, preferably less than approximately 200 millimetres, so that a relatively small manually operable respiration aid 1 may be obtained.

25 The feet 10, 11 may serve as a spacer arrangement, keeping the rigid walls 3, 4 at a minimum distance, as is indicated in Fig. 4B and 4C. To that end, the feet 10, 11 may be provided with flanges 12,13, respectively, that abut when the respiration aid is in closed condition. The material of the feet 10, 11 may be relatively rigid.

10

Fig. 5 shows a valve assembly 16, in particular a nonrebreathing valve assembly, having a predetermined PEEP function 16 at rest, which may be provided near the outlet 7A and/or patient connector 8 of a respiration aid 1. The valve assembly 16 may comprise a valve housing 14 and a motion 5 limiting body 15 that may be combined with a fixed spindle 17 for setting the pressure value of the valve assembly 16. A helical spring 18 may damp a freely movable valve 19 against a valve seat 21 by way of contact seat 20, so that the channel between the patient connector 8 and the outlet opening 22 is shut off. The spring 18 rests on a shoulder 23 of the fixed spindle 3. The 10 pressure value may be indicated on the fixed spindle, for instance by designing the spindle in a particular color and/or by indicating the PEEP value on the spindle. The valve assembly 16 may be a valve assembly as described in Dutch patent application NL1034284 or international patent application PCT/NL2008/050568, both applications being incorporated herein by reference. 15 In an embodiment, the respiration aid 1 may be provided in a reanimation package, also comprising a defibrillator for example. The respiration aid 1 may for example find application in supermarkets, elderly homes, train stations, hospitals, playgrounds, amusement parks, as well as other environments. In an embodiment, the respiration aid 1 is a resuscitator. 20 It shall be obvious that the invention is not limited in any way to the embodiments that are represented in the description and the drawings. Many variations and combinations are possible within the framework of the invention as outlined by the claims. Combinations of one or more aspects of the embodiments or combinations of different embodiments are possible within the 25 framework of the invention. All comparable variations are understood to fall within the framework of the invention as outlined by the claims.

Claims

A respiratory aid for administering gas to a patient, comprising a gas container, a gas inlet for allowing gas to enter into the container, and a gas outlet for allowing gas to be released from the container for administering to a patient, wherein the holder is provided with two relatively rigid walls and a relatively foldable wall between said relatively rigid walls, the relatively rigid walls being arranged such that they can be moved towards each other so that gas is released from the container through the gas outlet by pressure.

A respiratory aid according to claim 1, wherein the relatively rigid walls are arranged on opposite sides of the respiratory aid.

A respiratory aid as claimed in claim 1 or 2, provided with a resilient element coupled to the relatively rigid walls for exerting a resilient force on at least one of the relatively rigid walls in a direction away from the other relatively rigid wall.

4. Respiratory aid as claimed in any of the foregoing claims, wherein the respiratory aid is adapted as a manual respiratory aid for administering gas to a patient by squeezing gas from the container with one hand.

5. Respiratory aid as claimed in any of the foregoing claims, comprising a spacer device for setting a minimum distance between the two relatively rigid walls.

The respiratory aid of claim 5, wherein the spacer device is arranged on the inside of the container.

A respiratory aid according to any one of the preceding claims, comprising a safety valve for releasing excessive pressure from the container.

8. Respiratory aid as claimed in any of the foregoing claims, wherein the inlet valve comprises a two-way safety valve.

A safety device according to any one of the preceding claims, wherein a patient connector is coupled to the gas outlet for administering the gas to a patient.

10. Respiratory aid as claimed in claim 9, comprising a pipe 10 between the gas outlet and the patient coupling piece.

A respiratory aid according to any one of the preceding claims, comprising a PEEP valve.

12. Respiratory aid according to claim 11, wherein the PEEP valve is provided near the outlet and / or the patient connector of the respiratory aid.

The respiratory aid of claim 10 or 11, wherein the PEEP valve has a predetermined pressure value.

A resuscitation package comprising a defibrillator and a respiratory aid according to any one of the preceding claims.

A method for administering gas to a dummy or test person using a breathing aid, wherein a relatively rigid wall is moved in a direction of an opposite relatively rigid wall so that gas is compressed in a container between the walls, which gas is thereby released from the container and is administered to said dummy or test person.