AU1543202A - Breathing assistance apparatus - Google Patents

Description

-1- Regulation 3.2

AUSTRALIA

PATENTS ACT, 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT

ORIGINAL

Name of Applicant: Actual Inventor: Address for service in Australia: Invention Title: FISHER PAYKEL HEALTHCARE LIMITED Gregory James OLSEN, Martin LECKIE, Neil PRIME, Lewis George GRADON, Nicholas Charles Alan SMITH, Alastair Edwin McAULEY, Mark Joseph HAYCOCK and Chris Earl

NIGHTINGALE

A J PARK, Level 11, 60 Marcus Clarke Street, Canberra ACT 2601 Breathing Assistance Apparatus The following statement is a full description of this invention, including the best method of performing it known to me/us FIELD OF INVENTION This invention relates to delivery of respiratory gases particularly though not solely to patient interfaces for providing CPAP therapy to patients suffering from obstructive sleep apnoea (OSA).

BACKGROUND OF THE INVENTION In the art of respiration devices, there are well known a variety of respiratory masks which cover the nose and/or mouth of a human user in order to provide a :i continuous seal around the nasal and/or oral areas of the face such that gas may be provided at positive pressure within the mask for consumption by the user. The uses for S o10 such masks range from high altitude breathing aviation applications) to mining and fire fighting applications, to various medical diagnostic and therapeutic applications.

One requisite of such respiratory masks has been that they provide an effective seal against the user's face to prevent leakage of the gas being supplied. Commonly, in prior mask configurations, a good mask-to-face seal has been attained in many instances only ''15 with considerable discomfort for the user. This problem is most crucial in those applications, especially medical applications, which require the user to wear such a mask continuously for hours or perhaps even days. In such situations, the user will not tolerate the mask for long durations and optimum therapeutic or diagnostic objectives thus will not be achieved, or will be achieved with great difficulty and considerable user discomfort.

In common with prior art designs, is an inability to seal effectively when the user's face becomes distorted. For example, as shown in the prior art mask of Figure 1 when the user 300 is sleeping on his or her side, one side 302 of the headgear tends to be pulled tight while the other side 304 tends to be loose. This causes the axis of the mask 306 to be twisted with respect to the axis of the head 308 due to the net torque from the headgear resulting in leakage 310 on one side. The user 300 sleeping on his or her side may also distort the facial contours around the nasal area 312 and may lead to further leakage.

SUMMARY OF INVENTION It is an object of the present invention to provide a nasal mask which goes some way to overcoming the abovementioned disadvantages in the prior art or which will at least provide the industry with a useful choice.

Accordingly in one aspect the invention consists in a device for delivering a supply of gases to a user comprising or including: a patient interface, in use in fluid communication with said supply of gases, securement means attached to or around the head of said user, and engaging means adapted to slidingly engage said securement means with said patient interface.

0 In a second aspect the present invention consists in nasal mask for delivering gases to a user comprising or including: a body portion having a inlet, in use said inlet receiving a supply of gases, sealing means engaged with said body portion, and adapted to seal against the facial contours of said user, and engaging means adapted to in use provide a sliding engagement with a means of securement to a user, and a compressive force on said sealing means to ensure said supply of gases is delivered to a user without significant leakage.

In a third aspect the present invention consists in a CPAP system for delivering gases to a user comprising or including a pressurised source of gases, transport means in fluid communication with said pressurised source adapted to convey said gases, and a patient interface in fluid communication with said transport means in use delivering said gases to said user, the improvement comprising that said patient interface adapted to sliding engage with a means of securement to a user, to ensure said supply of gases is delivered to a user without significant leakage.

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.

-4- The invention consists in the foregoing and also envisages constructions of which the following gives examples.

BRIEF DESCRIPTION OF THE DRAWINGS One preferred form of the present invention will now be described with reference to the accompanying drawings in which; Figure 1 is a plan view of a prior art mask illustrating side leak, "..Figure 2 is a plan view of a mask according to the preferred embodiment of the :o:present invention, Figure 3 is a block diagram of a humidified continuous positive airway pressure 0 (CPAP system) as might be used in conjunction with the present invention, Figure 4 is an illustration of the mask in use according to the preferred embodiment of the present invention, Figure 5 is a front view of the mask illustrating the headgear securement to the mask, Figure 6 is a perspective view of the mask showing multiple engaging clips, Figure 7 is a perspective view of the mask showing the sliding strap clipped in place, Figure 8 is a side view of the sliding strap, Figure 9 is a perspective view of the cannula with the sliding strap Figure 10 is a side view of the cannula in use on a neonate, Figure 11 is a perspective view of the full face mask with sliding loop, Figure 12 is a front view of the full face mask with sliding loop, Figure 13 is a top view of the full face mask with sliding loop, Figure 14 is a front view of the single sliding strap on the mouthpiece, Figure 15 is a perspective view of the single sliding strap on the mouthpiece, Figure 16 is a side view of the single sliding strap on the mouthpiece, Figure 17 is a front view of the double sliding strap on the mouthpiece, and Figure 18 is a perspective view of the sliding strap for the full face mask.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention provides improvements in the field of patient interfaces for use in CPAP therapy. In particular an interface is described which is more comfortable for the user to wear and reduces the side leakage as compared with interfaces of the prior art. It will be appreciated that while a mask is described in the preferred embodiment, the present invention can be used in respiratory care generally or with a ventilator but will now be described below with reference to use in a humidified CPAP system.

With reference to Figure 3 a humidified Continuous Positive Airway Pressure system is shown in which a patient 1 is receiving humidified and pressurised *..*gases through a nasal mask 2 connected to a humidified gases transportation pathway or 0 inspiratory conduit 3. It should be understood that delivery systems could also be VPAP (Variable Positive Airway Pressure) and BiPAP (Bi-level Positive Airway Pressure) or numerous other forms of respiratory therapy. Inspiratory conduit 3 is connected to the outlet 4 of a humidification chamber 5 which contains a volume of water 6. Inspiratory conduit 3 may contain heating means or heater wires (not shown) which heat the walls of the conduit to reduce condensation of humidified gases within the conduit.

Humidification chamber 6 is preferably formed from a plastics material and may have a highly heat conductive base (for example an aluminium base) which is in direct contact with a heater plate 7 of humidifier 8. Humidifier 8 is provided with control means or electronic controller 9 which may comprise a microprocessor based controller executing computer software commands stored in associated memory.

Controller 9 receives input from sources such as user input means or dial through which a user of the device may, for example, set a predetermined required value (preset value) of humidity or temperature of the gases supplied to patient 1. The controller may also receive input from other sources, for example temperature and/or flow velocity sensors 11 and 12 through connector 13 and heater plate temperature sensor 14. In response to the user set humidity or temperature value input via dial 10 and the other inputs, controller 9 determines when (or to what level) to energise heater plate 7 to heat the water 6 within humidification chamber 5. As the volume of water 6 within humidification chamber 5 is heated, water vapour begins to fill the volume of the -6chamber above the water's surface and is passed out of the humidification chamber outlet 4 with the flow of gases (for example air) provided from a gases supply means or blower 15 which enters the chamber through inlet 16. Exhaled gases from the patient's mouth are passed directly to ambient surroundings in Figure 3.

Blower 15 is provided with variable pressure regulating means or variable speed fan 21 which draws air or other gases through blower inlet 17. The speed of variable speed fan 21 is controlled by electronic controller 18 (or alternatively the function of controller 18 could carried out by controller 9) in response to inputs from controller 9 and a user set predetermined required value (preset value) of pressure or fan speed via dial 19.

Nasal Mask 0 Referring to Figure 4 the nasal mask, according to the preferred embodiment of the present invention, is shown in detail. The mask includes a hollow body 102 with an inlet 103 connected to the inspiratory conduit 3. The mask 2 is positioned around the nose of the user 1 with the headgear 108 secured around the back of the head of the patient 1.

The restraining force from the headgear 108 on the hollow body 102 and the forehead rest 106 ensures enough compressive force on the mask cushion 104, to provide an effective seal against the patient's face.

The hollow body 102 is constructed of a relatively inflexible material for example, polycarbonate plastic. Such a material would provide the requisite rigidity as well as being transparent and a relatively good insulator. The expiratory gases can be expelled through a valve (not shown) in the mask, a further expiratory conduit (not shown), or any other such method as is known in the art.

Mask Headgear Referring now to Figures 4 and 5 the headgear 108 is shown connected to the hollow body 102. Rather than traditional fixed or adjustable attachments the present invention utilises a sliding engagement between the headgear 108 and the hollow body 102. This is achieved in one embodiment with a loop 120, running through harnessing clips 122, 124 on either side of the headgear 108 and over the top of the hollow body 102.

The loop 120 is reciprocally engaged with guides 126, 128 mounted on the top surface of the hollow body 102. The guides constrain the loop 120 but allow it to slide in and out, -7meaning the headgear 108 can move laterally, independently of the hollow body 102.

The advantage to this is as the face is contorted during various sleeping positions the headgear is able to move with the changes in position while the mask is left in the correct position on the nose of the user and an effective seal is maintained.

Additional guides 129, 130, 131 allow the user to adjust position of loop 120, giving ability to get different pressure on the seal depending on loop 120 position.

To further ensure user comfort and effective pressure on the mask cushion 104, headgear 108 may be constructed either using two straps running around the back of the user's head as shown in Figure 4 or with a partial skull cap or any other configurations as are known in the art. In this case the straps or partial skull cap would 9 0 be constructed using neoprene but may also be constructed using any material as is known in the art which will be comfortable for the user.

In a further embodiment shown in Figures 6, 7 and 8 the present invention is illustrated using a sliding strap to attach the headgear 108 to the hollow body 102. The strap 200, shown in Figure 8 in isolation, is constructed of polyacetal (Delrin 500P NCO10) using injection moulding techniques to give a polished finish. This material, similar to other nylon based derivatives, with its polished finish has a particularly low friction co-efficient, and therefore slides with respect to the hollow body 102 with very little resistance.

As shown in Figure 6, the hollow body 102 includes a number of engaging clips 202, in use the sliding strap 200 snaps into place into the engaging clips 202 and can only be removed therefrom using a substantial force. This means that with any normal use the sliding strap 200 will stay retained within the engaging clips 202. It will also be appreciated from Figure 6 that a number of clips are so provided, in order to allow pressure from different angles for different face shapes.

As shown in Figure 8 the sliding strap includes a mid-section 204 intended to reciprocate with the engaging clips 202, terminated at each end by loops 206, 208 which attach to the headgear. The first loop 206 is a full loop through which the headgear 108 is permanently attached with for example, a velcro strap. The loop 208 at the other end, is only a partial loop 210 designed so that a strap or loop from the headgear 108 can be -8easily slipped in or out of the open section 212 to allow easy removal and attachment of the mask.

In a further alternative the sliding loop or strap could form a continuous portion of the headgear. Other variations of the sliding connection are possible, for example a chip or knob in the loop or strap could slide withing slots in the mask body.

It will be appreciated that in all embodiments of the present invention the attachment from the headgear to the mask is designed to slide with the lowest possible friction while still ensuring adequate direct force on the mask cushion to the user's face.

As shown in Figure 2 the sliding connection 320 of the present invention allows the headgear 322,324 to provide even force on both sides of the mask 326. This avoids e.:e placing a torque on the mask and consequent mask twisting, which minimises mask leaks from the seal to the face 328.

Nasal Cannula It will be appreciated that the present invention may be equally applied to any *patient interface for delivery gases to a user.

Referring now particularly to Figures 9 and 10 we see that a nasal cannula 1100 is secured at its base to the back of a neonates head using strap 1150. The strap connects at the base of the neonates skull on the back of the neck. It connects to the cannula 1100 by way of a sliding strap 1152. This strap is secured by way of clips to the hard plastic body 1138 allowing the securing strap 1150 substantial relative movement with respect to the cannula 1100 as the neonate twists its head while providing adequate restraining force directly on the cannula 1100 without any twisting of the cannula 1100. In one embodiment this is accomplished by a plastic e.g. acetal sliding strap which engages into sliding clips on the outer face of the cannula. The Teflon strap is adjustably attached to the neck strap 150 to allow the tension to be adjusted to a comfortable level.

Alternatively a sliding loop could be employed.

Full Face Mask Referring to Figures 11 to 13 and 18 a number of further embodiments are illustrated particularly relating to full face masks. Similarly to the preceding embodiments in Figure 18 the mask 1200 is attached to headgear around the head of a -9patient with a sliding Teflon strap 1202. The strap engages through a channel 1201 moulded into the mask 1200.

Alternatively as seen in Figures 11 to 13 the mask 1200 is attached to the headgear with a sliding loop 1204. The loop engages with the headgear through Velcro loops 1206 and to the mask 1200 through clips 1208.

Mouthpiece Referring to Figures 14 to 16 a mouthpiece 1400 is shown employing embodiments of the present invention. The mouthpiece 1400 engages with sliding strap 1402 through a channel through the inlet 1404 of the mouthpiece 1400. Again as with the preceding embodiments the strap 1402 engages to the headgear through clips 1406 at each end. In Figure 17 two straps 1408, 1410 attach to the mouthpiece 1400 either side of the inlet 1404 in a further alternative. The mouthpiece employed could otherwise be as described in our European Patent Application No. 1163924 or other mouthpieces as would be contemplated by one skilled in the art.

It will be appreciated that numerous other interfaces for example E.T (endrotraceal) tubes might also be used in conjunction with the present invention.

o* .o 0 o0o.0

Claims (28)

1. A device for delivering a supply of gases to a user comprising or including: a patient interface, adapted to be in fluid communication with said supply of gases, and adapted to provide a substantially sealed flow path for said flow of gases to said user in at least a correct orientation and position on said user, headgear adapted to attach to or around the head of said user, and a sliding connection between said headgear and said patient interface. S".i

2. A device as claimed in claim 1 wherein said patient interface is a nasal mask. ooo•

3. A device as claimed in claim 2 wherein said nasal mask comprises or includes a body portion having an inlet receiving said supply of gases, and sealing means attached to or integrated with said body portion said sealing means adapted to seal against the facial contours of said user.

4. A device as claimed in claim 3 where said sliding connection adapted to allow said S" headgear substantial movement with respect to said nasal mask, while still providing compressive force on said sealing means to ensure said supply of gases is delivered to said user without significant leakage.

5. A device as claimed in anyone of claims 1 to 4 wherein said headgear comprises or includes a member engaged thereto, said engagement between said headgear and said member adapted to allow removable engagement.

6. A device as claimed in claim 5 wherein said member is elongate having a first end and a second end, a first closed loop located at said first end and a second partial loop having an open section located at said second end, whereby in use said securement means is substantially permanently attached to said first loop and substantially attached but easily removable from said second loop, said securement means being easily removable through said open section. -11-

7. A device as claimed in claims 5 or 6 wherein said engaging means further comprises or includes at least one restraining means on said body portion, in use said member is restrained in at least one dimension by, but which can slide easily within at least one other dimension, said restraining means and can be easily disengaged therewith.

8. A device as claimed in claim 1 wherein said patient interface is a nasal cannula.

9. A device as claimed in claim 1 wherein said patient interface is a full face mask.

10. A device as claimed in claim 1 wherein said patient interface is a mouthpiece.

11. A device as claimed in claim 1 wherein said patient interface is an entrotracheal tube.

12. A device as claimed in any one of claims 8 to 11 wherein said engaging means includes a low resistance sliding strap.

13. A device as claimed in claim 12 wherein said sliding strap is moulded from Teflon.

14. A device as claimed in any one of claims 8 to 11 wherein said engaging means includes a low resistance sliding loop.

A device as claimed in claim 14 wherein said sliding loop comprises a looped nylon filament.

16. A nasal mask for delivering gases to a user comprising or including: a body portion having a inlet, in use said inlet receiving a supply of gases, sealing means engaged with said body portion, and adapted to seal against the facial contours of said user, and engaging means adapted to in use provide a sliding engagement with a means of -12- securement to a user, and a compressive force on said sealing means to ensure said supply of gases is delivered to a user without significant leakage.

17. A nasal mask as claimed in claim 16 wherein said engaging means comprises or includes a restraining means, said restraining means adapted to in use accommodate an elongate member, said restraining means adapted to in use restrain said member in at least one dimension, but allow said member to slide easily within at least one other dimension, and providing a compressive force on said sealing means to avoid any significant leakage, said restraining means adapted to in use easily disengage with said member. **o

18. In a CPAP system for delivering gases to a user comprising or including a pressurised source of gases, transport means in fluid communication with said pressurised source adapted to convey said gases, and a patient interface in fluid communication with said transport means in use delivering said gases to said user, the improvement comprising that said patient interface adapted to sliding engage with a means of securement to a user, to ensure said supply of gases is delivered to a user without significant leakage.

19. In a CPAP system as claimed in Claim 18 the improvement further comprising that said system further comprises a humidifier to variably humidify said gases.

A device for delivering a supply of gases to a user comprising or including: a patient interface, adapted to be in fluid communication with said supply of gases, and adapted to provide a substantially sealed flow path for said flow of gases to said user in at least a correct orientation and position on said user, and headgear including at least a partial loop adapted to pass across the face of said user.

21. A device as claimed in claim 20 wherein said loop adapted to pass over and slidingly engage with said interface. -13-

22. A device as claimed in claim 20 wherein said loop adapted to pass at least partially through and slidingly engage with said interface.

23. A patent interface as described as any of the embodiments herein with reference to and as illustrated by any of the accompanying drawings.

24. A nasal mask as described as any of the embodiments herein with reference to and as illustrated by any of the accompanying drawings.

A full face mask as described as any of the embodiments herein with reference to 10 and as illustrated by any of the accompanying drawings. o

26. A cannula as described as any of the embodiments herein with reference to and as illustrated by any of the accompanying drawings. g* gi

27. A mouthpiece as described as any of the embodiments herein with reference to and S" as illustrated by any of the accompanying drawings.

28. A system for delivering respiratory gases to a user as described as any of the embodiments herein with reference to and as illustrated by any of the accompanying drawings. Dated: 5 February 2002 FISHER P KEL HEA THCARE LIMITED AJ Park Patent Attorneys for the Applicant