WO2012146369A2

WO2012146369A2 - Patient ventilation assembly

Info

Publication number: WO2012146369A2
Application number: PCT/EP2012/001751
Authority: WO
Inventors: Jens Petter Ianke; Kjell Ove Korneliussen; Tore Laerdal
Original assignee: Laerdal Global Health As
Priority date: 2011-04-28
Filing date: 2012-04-24
Publication date: 2012-11-01
Also published as: WO2012146369A3

Abstract

Patient ventilation assembly (200) comprising a mask (203) and a ventilation bag (201 ) connected to the mask. The mask (203) is adapted to seal about the mouth of a patient when pressed against the face in a sealing application direction. A patient flow aperture (217) of the ventilation bag (201) is substantially coaxial with the application direction. Also disclosed is a pressure relief valve.

Description

Patient ventilation assembly

The present invention relates to a patient ventilation assembly, also known as a resuscitator, adapted for giving breathing assistance to patients. In particular the invention relates to such a ventilation assembly which has been simplified with respect to earlier ventilation assemblies and which in addition exhibits various advantageous features.

Background

A plurality of patient ventilation assemblies are known from the prior art. The main components of such assemblies are a ventilation bag and a mouth interface such as a mask adapted to cover the patient's mouth. In addition the assembly comprises a plurality of valves which control of flow in and out of the ventilation bag and the airways of the patient. Among these is a pressure relief valve which prevents excessive pressure being inflated into the patient.

A concern connected with patient ventilation assemblies of this kind is that they should be disassembled and disinfected, such as by boiling in water, between each usage. Due to complexity of the assembly, the disinfection process is often skipped by the medical personnel. This is partly due to the time involved with disassembly and reassembly of the ventilation assembly. Further, the personnel may be concerned about not coping with the reassembly. An erroneous reassembly can lead to severe results when used on a patient.

Another concern with known resuscitators is that the users often find it difficult to establish an air-tight application over the mouth of the patient, while simultaneously operating the ventilation bag.

US patent application publication US 20050139220 shows a ventilation bag with an outlet aperture facing in the same direction as the face mask. However, the mask is displaced away from the central axis of the ventilation bag.

US patent application publication US 2006091829 describes a bag mask resuscitator having a pressure relief valve (36, cf. Fig. 5). The pressure relief valve is arranged in association to the bag, on the side of the bag that faces the patient.

A novel design of a resuscitation assembly adapted for breathing assistance is provided, according to the various aspects of the invention.

The invention

According to a first aspect of the present invention, there is provided a patient ventilation assembly comprising a mask and a ventilation bag connected directly or indirectly to the mask. The mask is adapted to seal against the face and about the mouth of a patient, when pressed against the face in a sealing application direction. According to the invention, a patient flow aperture of the ventilation bag is substantially coaxial with the application direction. More specifically, the patient flow opening of the patient ventilation bag has a centre axis which is parallel with the flow direction out of the ventilation bag when the bag is compressed by the user. Thus, the mouth of the opening could also be shaped along a plane which is not strictly perpendicular to the centre axis, while the flow would still follow the direction of the centre axis.

As stated above, the mask is adapted to seal against the face about the mouth. The mask may also seal about the nose, in addition to the mouth.

With such a patient ventilation assembly, the user may, by using one hand only, apply the necessary application force to ensure sufficient contact between the mask and the face of the patient, as well as simultaneously performing compressions of the ventilation bag. In this way the user will have the other hand available for other purposes, such as holding the patient's head in a correct position.

In one embodiment of the first aspect of the present invention, a ring-shaped sealing edge protrudes out from the ventilation bag and encircles a pressure relief valve. The sealing edge exhibits a size that can be covered by a finger of an adult person in a sealing manner. In this way, the user can suppress the function of the pressure relief valve by blocking its outlet with a finger. As will appear from the example description below, he may do this with the same hand with which he performs the bag compression. In one embodiment of the first aspect of the present invention, the external surfaces of the patient ventilation assembly are substantially symmetric about a center axis. A result of this feature is that the assembly can be held by the user and can be applied to the patient face in an arbitrary rotational alignment about the centre axis. The ventilation bag and the mask are components being directly manually operated (i.e. compression and application against the face of the patient). Components not being directly manually operated, such as an intake valve, may be dissymmetric with respect to the centre axis. Such components will not affect the possible application angle of the assembly. In one embodiment of the first aspect of the present invention, the side of the ventilation bag which is opposite to the patient flow aperture is provided with an assembly support by means of which the patient ventilation assembly can stand upright on a planar surface. This feature contributes in maintaining the mask of the assembly clean, as it will not get into contact with the table or another surface onto which the assembly is placed. In addition, by placing the assembly in such an upright position, it will occupy less of the surface onto which it is placed. If the assembly is made symmetric, as discussed above, the centre axis would be vertical when in a standing position. The assembly could then be grabbed by the user from any arbitrary angle without the need of rotational repositioning in the hand before use. In other words, the ventilation assembly can be grabbed by the user with one hand and placed directly against the face of the patient, without the need to re-position the assembly in the hand. The other hand may thus remain with another task, such as stabilizing the head of the patient.

The assembly support can exhibit a perimeter within which an air intake valve is arranged. Such a perimeter can be in the form of a circle, possibly a concentric circle, in the bottom end of the ventilation bag (opposite of the patient end of the ventilation bag). By arranging the air intake valve within this perimeter, the valve will not pick up dust or impurities when stored in the upright position, since it is covered by the other parts of the ventilation bag. As will appear from an example description further below, the ventilation bag may comprise a plurality of air intake valves within the perimeter.

A pressure relief valve may also be arranged within the perimeter. Furthermore, a ring-shaped sealing edge can protrude out from the ventilation bag and encircle the pressure relief valve. The sealing edge can then be of a size that can be covered by a finger of an adult person in a sealing manner. In this way the user can override the pressure relief valve. This will be described further below.

In one embodiment, the ventilation bag, comprising the assembly support and the air intake valve is formed in one single non-separable component. It can also comprise the pressure relief valve. This feature results in few separate parts of the patient ventilation assembly. This facilitates correct re-assembly and cleaning of the patient ventilation assembly. In such embodiments the ventilation bag can be manufactured by means of molding. The assembly can further comprise a cover adapted to connect to the

ventilation bag by engagement with the perimeter. For instance, it can be snapped onto the perimeter with an engaging snapping edge, or it can be connected by means of threads. The cover comprises a through channel with an inner channel edge adapted to seal against the sealing edge encircling the pressure relief valve and an outer channel edge having a size and shape that can be covered by a finger of an adult person in a sealing manner. As explained above, the user may then override the pressure relief valve with a finger, while using the other fingers to perform the compressing movement. As briefly mentioned above, with a patient ventilation bag according to the first aspect of the present invention, the user can maintain a required force from the mask against the face of the patient in order to obtain sufficient sealing, while still performing the compression on the ventilation bag, with one hand only. This action is facilitated by the fact that the compression movement is in another direction than the application force towards the face / mouth region of the patient.

According to a second aspect of the present invention, there is provided a patient ventilation assembly comprising a compressible ventilation bag and a mask connected directly or indirectly to the ventilation bag. According to the second aspect of the invention, the ventilation bag exhibits an assembly support by means of which the assembly may stand in an upright position on a planar surface, elevating the mask above the level of the ventilation bag.

With such an assembly, the mask can be retained from contact with the surface on which the assembly is placed.

Preferably, the assembly support, i.e. the part being in contact with the planar surface, is a part not detachable from the ventilation bag.

According to a third aspect of the present invention, there is provided a patient ventilation assembly comprising a mask and a ventilation bag connected directly or indirectly to the mask. The mask is adapted to seal against the face and about the mouth of a patient. According to the third aspect of the invention, a pressure relief valve is arranged in a wall part of the mask.

This feature has several advantages. One is that the user may override the pressure relief valve with the same hand that keeps the patient mask onto the face of the patient. The user can then use his other hand to compress the bag. Another advantage of the third aspect of the present invention is that the pressure relief valve is arranged in association with the pressure which it is intended to control. That is, by arranging the valve in connection with the bag, the valve will be actuated when the bag pressure exceeds a certain value.

However, it is the pressure in the patient mask which is the critical pressure in this respect. Due to components between the bag and the mask, such as a patient air intake valve, the pressures in the mask and in the bag are not necessarily the same. With a poor functioning patient air intake valve these pressure may even be rather different. In such a case, having the pressure relief valve in a wall of the mask results in a more accurate pressure limitation function of the pressure inflated into the patient.

In an advantageous embodiment of the third aspect of the present invention, the pressure relief valve is surrounded by a sealing edge which is sufficiently small to make a sealing contact with a finger of an adult.

In an embodiment of the third aspect of the present invention, the mask is adapted to seal against the face and about the mouth of the patient when pressed against the face in a sealing application direction, and a patient flow aperture of the ventilation bag is substantially coaxial with the application direction.

Preferably, the pressure relief valve can be a slit valve.

According to a fourth aspect of the present invention, there is provided a mask and a ventilation bag connected directly or indirectly to the mask, wherein the mask is adapted to seal against the face and about the mouth of a patient when pressed against the face in a sealing application direction. According to this aspect of the invention, the side of the ventilation bag which is opposite to the patient flow aperture is provided with an assembly support by means of which the patient ventilation assembly can stand on a planar surface.

Example of embodiment

Having described the various aspects of the invention in general terms above, a more detailed and non-limiting description of an example embodiment is given below with reference to the drawings, in which

Fig. 1 shows a patient ventilation assembly of the prior art;

Fig. 2 shows a patient ventilation assembly according to the present invention; Fig. 3 shows four separate parts which when assembled together form a

ventilation assembly;

Fig. 4 shows a patient end of the ventilation bag;

Fig. 5 shows a bottom end of a ventilation bag; Fig. 6 shows a slit type valve in an open position;

Fig. 7 shows a cover adapted to be attached to the bottom section of the bag; Fig. 8 shows the opposite side of the cover shown in Fig. 7;

Fig. 9 shows a patient mask provided with a pressure relief valve in the mask wall;

Fig. 10 shows the patient facing portion of the patient ventilation assembly; Fig. 11 shows a patient mask being applied onto the face of a newborn baby; and

Fig. 12 shows the mask being applied onto the face as in Fig. 11 , however with the mask in a rotated position compared to Fig. 11.

Fig. 1 shows a known patient ventilation assembly 100. It comprises a ventilation bag 101 and a mask 103 adapted to be placed to the patient's mouth and thus establish fluid communication between the ventilation assembly 100 and the airways of the patient. A transition piece 105 is connected between the ventilation bag 101 and the mask 103. In the transition piece 105 is a one way patient intake valve 107 which ensures that air flowing out of the patient does not flow back into the ventilation bag 101 but out of the ventilation assembly 100. In addition the ventilation assembly 100 has a pressure relief valve 109 which is adapted to open to the surroundings when excessive pressure arises in the ventilation assembly. To a bottom side of the ventilation bag 101 there is connected a cover 111 which exhibits an oxygen reservoir connection means 113 for attachment to an oxygen reservoir (not shown) and a gas source connection means 115 for attachment to a gas source (not shown), such as an oxygen source.

The transition piece 105 results in that the mask 103 is directed orthogonally with respect to the centre axis of the bag 101. From the prior art there are known a plurality of patient ventilation assemblies having a rigid connection between the bag and mask, while others have a flexible connection.

Fig. 2 shows an embodiment of a patient ventilation assembly 200 according to the present invention. It has several components that correspond to the components of the known ventilation assembly 100 shown in Fig. 1. These components are given reference numbers corresponding to the components in Fig. 1 , however in the 200-series, whereas the components in Fig. 1 are given reference numbers in the 100-series. The transition piece 205 shown in Fig. 2 is symmetric and/or coaxially designed, resulting in a coaxial arrangement of the mask 203 with respect to the bag 201.

Fig. 3 shows the patient ventilation assembly 200 shown in Fig. 2 when in a disassembled state. The ventilation bag 201 has a patient end 201a and a bottom end 201b. At the patient end 201a the ventilation bag 201 exhibits a flow aperture 217, out of which gas (air) flows out of the ventilation bag 201 into the mask 203 when the assembly 200 is in use. The flow aperture 217 exhibits a circular rim 217a. In this embodiment the rim 217a is circular and extends in a plane orthogonal to the flow direction through the flow aperture 217. When compressing the ventilation bag 201 in order to provide flow out of the flow aperture 217, the user will compress the middle part of the ventilation bag 201 by hand. The compression direction will be in a radial direction, crosswise to the axial flow direction out of the flow aperture 217.

Fig. 3 also shows the transition piece 205 which connects the ventilation bag 201 to the mask 203. The transition piece 205 exhibits external threads that engage with internal threads within the rim 217a of the flow aperture 217. When assembling the patient ventilation assembly 200, the patient intake valve 207 is landed within the flow aperture 217 of the ventilation bag 201. The patient intake valve 207 has a circular shape with a central functional part which lets air through only in one direction and which extends above the circular shape in an axial direction. After landing the patient intake valve 207 within the flow aperture 217, the transition piece 205 is threaded onto the ventilation bag 201 , and keeps the patient intake valve 207 in its place. The mask 203 connects to the transition piece 205 with a sleeve that is inserted into a larger sleeve part of the transition piece 205. This is shown in Fig. 2.

Fig. 4 shows the patient end 201a of the ventilation mask 201 from another angle. From this view one can see the internal threads within the rim 217a as well as a landing shoulder 219 that keeps the patient intake valve 207 in the correct axial position. I.e., when the patient ventilation assembly 200 is assembled, the patient intake valve 207 is retained in its axial position by the landing shoulder 219 and an abutting face of the transition piece 205. In the central portion of the flow aperture 217 there is arranged an aperture element in the form of a beam 221 that traverses the flow aperture 217. The main object of this beam 221 is to prevent that the user mounts the patient intake valve 207 in an erroneous direction. Since the patient intake valve 207 exhibits a middle functional part which extends axially out from its circular shape, the beam 221 will collide with the patient intake valve 207 if the user attempts to mount it in the wrong direction. Thus, the beam 221 ensures that the patient intake valve 207 will be correctly installed.

Fig. 5 shows the bottom end 201b of the ventilation bag 201, seen from below. The bottom end 201b exhibits a perimeter 223 that forms an assembly support for the patient ventilation assembly 200. In this embodiment the assembly support is shaped as a circular perimeter 223 or edge which, when the patient ventilation assembly 200 is placed on a planar surface, ensures that it does not tip over.

In this embodiment there are arranged three air intake valves 225 in the bottom end 201b, within the perimeter 223. With regards to valve functionality the air intake valves 225 work in the same way as the patient intake valve 207 does. They exhibit a middle functional part of a flexible sheet material with a cleft in the end. The cleft opens at pressure from the external side of the ventilation bag 201 and closes when the pressure inside the ventilation bag 201 is larger than the external pressure.

Also arranged in the bottom end 201b of the ventilation bag 201 , in this embodiment, is a pressure relief valve 209. The pressure relief valve 209 is in the form of a slit valve having two slits that cross each other. At a given excessive pressure within the ventilation bag 201 , the slits will open and form an outlet 209a between them. This is shown in the enlarged view of Fig. 6, showing the pressure relief valve 209 in an open position. Also shown in Fig. 5 is a sealing edge 227 that surrounds the pressure relief valve 209. The sealing edge 227 extends a portion axially out beyond the pressure relief valve 209. It is so dimensioned that the front part of an index finger can cover the entire sealing edge 227, thereby sealing off the pressure relief valve 209 from the ambient pressure. Thus, in order to override the pressure relief valve 209, if needed, the user of the patient ventilation assembly 200 can seal off the pressure relief valve 209 with his index finger, while using his thumb and three remaining fingers of one hand to compress the ventilation bag 201.

Advantageously, the entire flexible portion of the ventilation bag 201 as well as the bottom end 201b, with the air intake valves 225 and pressure relief valve 209 are made in one molding process. The employed material can be silicone, making the ventilation bag 201 resistant to high temperatures during cleaning and disinfection, while still maintaining the desired functionality.

The description above referring to Fig. 2 to Fig. 6 describes a patient ventilation assembly 200 according to the invention, and includes the components which are needed for the required functionalities of the patient ventilation assembly. Such components includes an air intake valve, a patient intake valve that prevents air returning from the patient into the ventilation bag, a compression portion of the bag, and patient interface in the form of a mask. Fig. 7 shows the internal side of a cover 429 which is adapted to be attached to the bottom end 201b of the ventilation bag 201. It may for instance be snapped onto the perimeter 223 shown in Fig. 5. The cover 429 has a through channel 431 shaped as a sleeve having an inner channel edge 431a and an outer channel edge on the opposite side. The inner channel edge 431a is adapted to seal against the sealing edge 227 that encircles the pressure relief valve 209 of the ventilation bag 201 (cf. Fig. 5). Thus, the outer channel edge 431b of the cover 429 has the same function as the sealing edge 227, i.e. the user can put his index finger onto the outer channel edge 431 b in order to deactivate the function of the pressure relief valve 209. The cover 429 further has a connection means 413 adapted to be connected to an oxygen reservoir. It also has a gas source connection means 415. The opposite side of the cover 429 is shown in Fig. 8. Fig. 9 shows a patient mask 303 which is different from the mask 203 described with reference to Fig. 2 to Fig. 6. In this mask 303, there is arranged a pressure relief valve 309 in the mask wall. In this embodiment, the pressure relief valve 309 is a slit valve, such as the one shown in Fig. 6. However, other types of pressure relief valves would also be possible. As with the pressure relief valve 209 described above, also this pressure relief valve 309 exhibits a sealing edge 327 which is adapted to seal against a finger of the user.

Fig. 10 shows an enlarged view of the mask 303 shown in Fig. 9, connected to the transition piece 305 on the patient side 301a of the bag. A cross shaped slit is provided in a flexible layer in such way that when an excessive pressure difference exists between the interior and the exterior sides of the mask, the layer will be flexed and an outlet will be formed by the slit, thereby letting air pass out through the valve. This is shown in the enlarged view of Fig. 6, showing a pressure relief valve 209 in an open position.

Fig. 11 and Fig. 12 show the patient mask 303 of the patient ventilation assembly applied onto the face of a newborn baby 500. In the position shown, the user employs one hand to maintain the mask 303 in the correct position onto the face of the baby 500. With the same hand he keeps the head in a correct position, by supporting it with some fingers at the chin and cheek of the head of the baby 500. In the position shown in Fig. 11 , the user blocks the pressure relief valve 309 by covering the sealing edge 327 with his thumb. The sealing edge 327 of the pressure relief valve 309 encircles the valve and is dimensioned in such way that the user may block the fluid communication of the ^' pressure relief valve 309 to the exterior side of the mask 303. Fig. 12 shows the same situation however with the patient mask 303 rotated so that the pressure relief valve 309 is in another position. Thus, with the pressure relief valve 309 located at a wall part of the patient mask 303, the user is able to override the pressure relief valve 309 with the same hand as he uses to support the head and retain the patient mask 303 in a sealing position against the face of the baby 500 or other patient.

The above description of various embodiments illustrates a plurality of features of which many will exhibit technical results regardless of other features of the same embodiment. It should hence be understood that, although illustrated in combination with other features, the features are not bound to any specific combination of other features, provided their technical results still apply. Thus, as will be appreciated by the person skilled in the art, a plurality of various embodiments of the present invention is possible within the scope of the claims.

Claims

1. Patient ventilation assembly (200) comprising a mask (203) and a ventilation bag (201) connected directly or indirectly to the mask, wherein the mask (203) is adapted to seal against the face and about the mouth of a patient, when pressed against the face in a sealing application direction, characterized in that a patient flow aperture (217) of the ventilation bag (201) is substantially coaxial with the application direction.

2. Patient ventilation assembly (200) according to claim 1 , characterized in that a ring-shaped sealing edge (227) protrudes out from the ventilation bag (201) and encircles a pressure relief valve (209), wherein the sealing edge (227) exhibits a size that can be covered by a finger of an adult person in a sealing manner.

3. Patient ventilation assembly according to claim 1 , characterized in that its external surfaces are substantially symmetric about a centre axis.

4. Patient ventilation assembly according to claim 1 , 2 or 3, characterized in that the side of the ventilation bag (201) which is opposite to the patient flow aperture (217) is provided with an assembly support (223) by means of which the patient ventilation assembly (200) can stand on a planar surface.

5. Patient ventilation assembly according to claim 4, characterized in that the assembly support exhibits a perimeter (223) within which an air intake valve (225) and/or a pressure relief valve (209) is arranged.

6. Patient ventilation assembly according to claim 5, characterized in that the ventilation bag (201), the assembly support (223), and the air intake valve (225) is formed in one single non-separable component.

7. Patient ventilation assembly according to claim 5, characterized in that it further comprises a cover (429) adapted to connect to the ventilation bag (201) by

engagement with the perimeter (223), which cover (429) comprises a through channel (431) with an inner channel edge (431a) adapted to seal against the sealing edge (227) encircling the pressure relief valve (209) and an outer channel edge (431b) having a size and shape that can be covered by a finger of an adult person in a sealing manner.

8. Patient ventilation assembly (200) comprising a compressible ventilation bag (201) and a mask (203) connected directly or indirectly to the ventilation bag,

characterized in that the ventilation bag (201) exhibits an assembly support (223) by means of which the assembly may stand in an upright position on a planar surface, elevating the mask (203) above the level of the ventilation bag (201).

9. Patient ventilation assembly comprising a mask (303) and a ventilation bag connected directly or indirectly to the mask, wherein the mask (303) is adapted to seal against the face and about the mouth of a patient (500), characterized in that a pressure relief valve (309) is arranged in a wall part of the mask (303).

10. Patient ventilation assembly according to claim 9, characterized in that the pressure relief valve (309) is surrounded by a sealing edge (327) which is sufficiently small to make a sealing contact with a finger of an adult.

11. Patient ventilation assembly according to claim 9 or 10, characterized in that the mask (303) is adapted to seal against the face and about the mouth of the patient (500) when pressed against the face in a sealing application direction, and that a patient flow aperture (217) of the ventilation bag (201) is substantially coaxial with the application direction.

12. Patient ventilation assembly according to claim 9, 10, or 11 , characterized in that the pressure relief valve (309) is a slit valve.

13. Patient ventilation assembly (200) comprising a mask (203) and a ventilation bag (201) connected directly or indirectly to the mask, wherein the mask (203) is adapted to seal against the face and about the mouth of a patient, when pressed against the face in a sealing application direction, characterized in that the side of the

ventilation bag (201) which is opposite to the patient flow aperture (217) is provided with an assembly support (223) by means of which the patient ventilation assembly (200) can stand on a planar surface.