WO2012077036A2

WO2012077036A2 - Headgear apparatus providing enhanced stability

Info

Publication number: WO2012077036A2
Application number: PCT/IB2011/055457
Authority: WO
Inventors: Jerome Matula Jr.; Peter Chi Fai Ho
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2010-12-08
Filing date: 2011-12-05
Publication date: 2012-06-14
Also published as: WO2012077036A3

Abstract

A headgear for securing a mask to a patient including a first, a second, and a third strap member. The first strap member includes first and second ends coupled to the mask, and a mid portion engaging an upper rear portion of the head. The second strap member includes a first end, an opposite second end, and a mid portion. The first end is coupled to a first side, and the second end is coupled to a second side, of the first strap member. The mid portion engages a mid portion of the rear of the head when the headgear is worn. The third strap member includes a first end coupled to the first side of the first strap member and a second end coupled to the second side of the first strap member. The mid portion of the third strap member is adapted to engage the chin, nose, or forehead of the patient.

Description

HEADGEAR APPARATUS PROVIDING ENHANCED STABILITY

CROSS-REFERENCE TO RELATED APPLICATIONS

[01] This patent application claims the priority benefit under 35 U.S.C. § 1 19(e) of U.S. Provisional Application No. 61/420,964 filed on December 8, 2010, the contents of which are herein incorporated by reference.

BACKGROUND OF THE INVENTION

1 . Field of the Invention

[02] The present invention pertains to respiratory interface devices, and, in

particular, to headgear for use in securing a mask to a patient.

2. Description of the Related Art

[03] There are numerous situations where it is necessary or desirable to deliver a flow of breathing gas non-invasively to the airway of a patient, i.e., without intubating the patient or surgically inserting a tracheal tube in their esophagus. For example, it is known to ventilate a patient using a technique known as non-invasive ventilation. It is also known to deliver continuous positive airway pressure (CPAP) or variable airway pressure, which varies with the patient's respiratory cycle, to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), or congestive heart failure.

[04] Non-invasive ventilation and pressure support therapies involve the

placement of a respiratory patient interface device including a mask component on the face of a patient. The mask component may be, without limitation, a nasal mask that covers the patient's nose, a nasal cushion having nasal prongs that are received within the patient's nares, a nasal/oral mask that covers the nose and mouth, or full face mask that covers the patient's face. The respiratory patient interface device interfaces the ventilator or pressure support device with the airway of the patient, so that a flow of breathing gas can be delivered from the pressure/flow generating device to the airway of the patient. It is known to maintain such devices on the face of a wearer by a headgear having one or more straps adapted to fit over/around the patient's head. Because such respiratory patient interface devices are typically worn for an extended period of time, it is important for the headgear to maintain the mask component of the device in a tight enough seal against the patient's face without discomfort.

[05] For respiratory patient interface devices, a key engineering challenge is to balance patient comfort against the stability of the device. As a patient changes sleeping positions through the course of the night, the mask portions of respiratory patient interface devices may become dislodged, and the seal against the patient's may be broken or compromised. A dislodged mask portion can be stabilized by the increasing strapping force provided by the headgear, but increased strapping force tends to reduce patient comfort. This design conflict is further complicated by the widely varying facial geometries that a given respiratory patient interface device design needs to accommodate.

[06] Existing pillows type masks are generally not stable and thus are not able to be used at higher pressures. One known example of a respiratory patient interface device that utilizes such a pillows type mask is the Swift LT available from ResMed Inc. FIG. 1 shows an example of such known device, generally indicated as 10, which includes a nasal pillows mask 12 adapted to be secured to a patient's head via headgear 14 as shown. Headgear 14 includes a first strap member 16 coupled to nasal mask 12 and disposed generally about an upper portion of a patient's head. Headgear 14 further includes a second strap member 18 that is coupled to first strap member on either side of a patient's head and is disposed below first strap member at about a mid portion of the rear of a patient's head. Such design is generally adequate for use at low operating pressures but does not provide suitable stability for use at higher operating pressures.

SUMMARY OF THE INVENTION

[07] Accordingly, it is an object of the present invention to provide a headgear for use in securing a mask to the head of a patient that overcomes the shortcomings of conventional headgear. This object is achieved according to one embodiment of the present invention by providing a headgear for use in securing a mask to the head of a patient. The headgear includes a first strap member, a second strap member and a third strap member. The first strap member has a first end, an opposite second end, and a mid portion therebetween. The first and second ends are adapted to be coupled to the mask and the mid portion is adapted to engage an upper rear portion of the head of the patient when the mask and headgear are installed on the patient.

[08] The second strap member has a first end, an opposite second end, and a mid portion therebetween. The first end is coupled to a first side of the first strap member between the mid portion and the first end of the first strap member and the second end is coupled to a second side of the first strap member between the mid portion and the second end of the first strap member. The mid portion of the second strap member is adapted to engage a mid portion of the rear of the head of the patient when the mask and headgear are installed on the patient.

[09] The third strap member has a first end, an opposite second end, and a mid portion disposed therebetween. The first end of the third strap member is coupled to the first side of the first strap member and the second end is coupled to the second side of the first strap member. The mid portion of the third strap member is adapted to engage one of the chin, nose, or forehead of the patient when the mask and headgear are installed on the patient.

[10] The object is achieved according to another embodiment of the present invention by providing another headgear for use in securing a mask to the head of a patient. The headgear includes a first strap member and a second strap member. The first strap member includes a first end adapted to be coupled to the mask, an opposite second end adapted to be coupled to the mask, and a mid portion disposed between the first end and the second end. The mid portion is adapted to engage an upper rear portion of the head of the patient when the mask and headgear are installed on the patient. The first strap member further includes a first flared portion disposed generally about the first end and a second flared portion disposed generally about the second end. The first flared portion is adapted to engage the cheek bone area of the patient when the mask and headgear are installed on the patient and the second flared portion adapted to engage the cheek bone area of the patient when the mask and headgear are installed on the patient. [11] The second strap member includes a first end, an opposite second end, and a mid portion therebetween. The first end is coupled to a first side of the first strap member between the mid portion and the first end of the first strap member and the second end is coupled to a second side of the first strap member between the mid portion and the second end of the first strap member. The mid portion is adapted to engage a mid portion of the rear of the head of the patient when the mask and headgear are installed on the patient.

[12] These and other objects, features, and characteristics of the present

invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention.

BRI EF DESCRI PTION OF THE DRAWI NGS

[13] FIG. 1 is an isometric view of a known respiratory patient interface device;

[14] FIG. 2A is an isometric view of a front and left side of a respiratory patient interface device according to one particular embodiment of the present invention;

[15] FIG. 2B is an isometric view of the front and right side of the particular embodiment of the respiratory patient interface device of FIG. 2A;

[16] FIG. 3 is an isometric view of a respiratory patient interface device

according to another particular embodiment of the present invention;

[17] FIG. 4 is an isometric view of a respiratory patient interface device

according to a further particular embodiment of the present invention;

[18] FIG. 5 is an isometric view of a respiratory patient interface device

according to yet another particular embodiment of the present invention;

[19] FIG. 6 is a cross sectional view of a portion of a strap member according to a particular embodiment of the present invention; and [20] FIG. 7 is a cross sectional view of a portion of a strap member according to another particular embodiment of the present invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[21] As used herein, the singular form of "a", "an", and "the" include plural references unless the context clearly dictates otherwise. As used herein, the statement that two or more parts or components are "coupled" shall mean that the parts are joined or operate together either directly or indirectly, i.e., through one or more intermediate parts or components, so long as a link occurs. As used herein, "directly coupled" means that two elements are directly in contact with each other. As used herein, "fixedly coupled" or "fixed" means that two components are coupled so as to move as one while maintaining a constant orientation relative to each other.

[22] As used herein, the word "unitary" means a component is created as a single piece or unit. That is, a component that includes pieces that are created separately and then coupled together as a unit is not a "unitary" component or body. As employed herein, the statement that two or more parts or components "engage" one another shall mean that the parts exert a force against one another either directly or through one or more intermediate parts or components. As employed herein, the term "number" shall mean one or an integer greater than one (i.e., a plurality).

[23] Directional phrases used herein, such as, for example and without

limitation, top, bottom, left, right, upper, lower, front, back, and derivatives thereof, relate to the orientation of the elements shown in the drawings and are not limiting upon the claims unless expressly recited therein. Like numbers refer to like elements throughout.

[24] FIGS. 2A and 2B illustrate an exemplary embodiment of a patient interface device 30 according to the principles of the present invention. Patient interface device 30 includes a nasal pillows mask 32 that is adapted to be secured to the head of a patient (as shown) by a headgear 34. Headgear 34 includes a main, or first strap member 36 having a first end 38, an opposite second end 40, and a mid portion 42 therebetween. First and second ends 38, 40 are coupled, either permanently or selectively, to nasal mask 32 by any suitable fastening mechanism (e.g., without limitation, glue, snap, hook and loop). [25] When headgear 34 is secured on a patient's head, as shown in FIGS. 2A and 2B, mid portion 42 is positioned generally at an upper rear portion of the patient's head such that a first side 44 of first strap member 36 extends along the left side of the patient's head, as shown in FIG. 2A, passing above the left ear of the patient and a second side 46 extends along the right side of the patient's head, as shown in FIG. 2B, passing above the right ear of the patient. In an exemplary embodiment, first strap member 36 is formed from a silicone or other suitable semi-rigid material. As a variation of the embodiment shown in FIGS. 2A an 2B, first strap member 36 may be formed from two separate portions coupled together via an adjustable coupling as known in the art that allows for the overall length of first strap member 36 to be adjusted and thus securely fitted to the patient's head.

[26] Continuing to refer to FIGS. 2A and 2B, headgear 34 further includes a second strap member 48 having a first end 50, an opposite second end 52, and a mid portion 54 disposed therebetween. First end 50 is coupled to first side 44 of first strap member 36 generally above the patient's left ear (FIG. 2A) and second end 52 is coupled to second side 46 of first strap member 36 generally above the patient's right ear (FIG. 2B). In an exemplary embodiment, second strap member 48 is formed from a flexible material (e.g., without limitation, silicone, neoprene) and coupled to first strap member 36 via an adjustable coupling mechanism (e.g., without limitation, VELCRO®) at one or both of first and second ends 50, 52 to provide for precise fitting of headgear 34 to a patient's head. When secured on a patient's head, mid portion 54 is positioned generally about half way up the rear of the patient's head as shown generally in FIGS. 2A and 2B.

[27] Headgear 34 further includes a third strap member 56, which functions generally as a chin strap, having a first end 58, an opposite second end 60, and a mid portion 62 disposed therebetween. First end 58 of third strap member 56 is coupled to first side 44 of first strap member 36 generally about the left cheek area of a patient, as shown in FIG. 2A, and second end 60 is coupled to second side 46 of first strap member 36 generally about the right cheek area of a patient such that mid portion 62 generally engages the underside of the chin of the patient. In the embodiment shown in FIGS. 2A and 2B, third strap member 56 is formed integrally with first strap member 36 to form a unitary member formed, for example, from silicone or other suitable semi-rigid material.

[28] It is to be appreciated, however, that third strap member 56 may be

separately formed and then coupled, either fixedly or adjustably, via any suitable coupling means, to first strap member 36. Such combination of strap members 36, 48 and 56 provides a more secure arrangement, and thus better sealing of mask 32 to the patient than that provided by known masks and thus allows for the use of higher air supply pressures to mask 32.

[29] FIGS. 3-5 show further exemplary embodiments of patient interface

devices 130, 230, and 330 according to the present invention. Although only one side of the head of a patient is shown in FIGS. 3-5, and thus generally only one side of each patient interface device 130, 230 and 330, it is to be appreciated that like the patient interface device 30 depicted in FIGS. 2A and 2B, the patient interface devices 130, 230 and 330 of FIGS. 3-5 are generally symmetrical from side to side, and thus the portions not shown are disposed relative to the right side of the patient's head in a similar manner as the left sides shown for each exemplary embodiment.

[30] FIG. 3 illustrates another exemplary embodiment of a patient interface device 130 according to the principles of the present invention. Like patient interface device 30 previously discussed, patient interface device 130 includes a nasal pillows mask 32 but utilizes a headgear 134 having a slightly different geometry than headgear 34 previously discussed. Like headgear 34, headgear 134 includes a main, or first strap member 36 having a first end 38, an opposite second end 40, and a mid portion 42 therebetween, and a second strap member 48 having a first end 50, an opposite second end (not shown in FIG. 3), and a mid portion 54 disposed therebetween that is adapted to be disposed on a patient generally as previously discussed in regard to FIGS. 2A and 2B.

[31] Unlike third strap member 56 (the chin strap) of headgear 34, headgear 134 includes a third strap member 156, which functions generally as a nose strap, having a first end 158, an opposite second end (not shown), and a mid portion 162 disposed therebetween. As shown in FIG. 3, first end 158 of third strap member 156 is coupled to first side 44 of first strap member 36 generally about the left cheek area of a patient and the second end is coupled to second side 46 (not shown in FIG. 3) of first strap member 36 generally about the right cheek area of a patient such that mid portion 162 generally engages the upper surface of the patient's nose. In the embodiment shown in FIG. 3, third strap member 156 is formed separately from first strap member 36, however, it is to be appreciated that third strap member 156 may be integrally formed with first strap member 36 so as to form a unitary member. It is also to be appreciated that third strap member 156 may be fixedly or adjustably coupled to first strap member 36 via any suitable coupling means. Such combination of strap members 36, 48 and 156 provides a more secure arrangement, and thus better sealing of mask 32 to the patient than that provided by known masks and thus allows for the use of higher air supply pressures to mask 32.

[32] FIG. 4 illustrates another exemplary embodiment of a patient interface device 230 according to the principles of the present invention. Like patient interface devices 30 and 130 previously discussed, patient interface device 230 includes a nasal pillows mask 32 but utilizes a headgear 234 having a slightly different geometry than headgear 34 and 134 previously discussed. Like headgear 34 and 134, headgear 234 includes a main, or first strap member 36 having a first end 38, an opposite second end 40, and a mid portion 42 therebetween. Headgear 234 also includes a second strap member 48 having a first end 50, an opposite second end 52 (not shown in FIG. 4), and a mid portion 54 therebetween adapted to be disposed on a patient generally as previously discussed in regard to FIGS. 2 A and 2B.

[33] Unlike third strap member 56 (the chin strap) of headgear 34 and third strap member 156 (the nose strap) of headgear 134, headgear 234 includes a third strap member 256, which functions generally as a forehead strap, having a first end 258, an opposite second end (not shown), and a mid portion 262 disposed therebetween. As shown in FIG. 4, first end 258 of third strap member 256 is coupled to first side 44 of first strap member 36 generally about the same area where first end 50 of second strap member 48 is coupled and the second end of third strap member is coupled to second side 46 (not shown in FIG. 4) of first strap member 36 generally about the same area where second end 52 (not shown in FIG. 4) of second strap member 48 is coupled (see FIG. 2B). Such coupling provides for mid portion 262 of third strap member 256 to generally engage the forehead of a patient.

[34] As shown in the example embodiment of FIG. 4, third strap member 256 may be integrally formed with second strap member 48 to form a single unitary strap member 270. In such embodiment, such unitary strap member 270 is preferably formed from a fabric-like or other suitable material (e.g., without limitation, neoprene, silicone) that is preferably slidably coupled to first strap member 36 in a manner that generally allows strap member 270 to slide in a direction generally perpendicular to first strap member 36. It is to be appreciated that third strap member 256, either integrally formed (as shown) or formed as a separate member, may be fixedly or adjustably coupled to first strap member 36 via any suitable coupling means. Such combination of strap members 36, 48 and 256 provides a more secure arrangement, and thus better sealing of mask 32 to the patient than that provided by known masks and thus allows for the use of higher air supply pressures to mask 32.

[35] FIG. 5 illustrates yet another exemplary embodiment of a patient interface device 330 according to the principles of the present invention. Like patient interface devices 30, 130, and 230 previously discussed, patient interface device 330 includes a nasal pillows mask 32 but utilizes a headgear 334 having a slightly different geometry than headgear 34, 134, and 234 previously discussed. Similar to headgear 34, 134, and 234, headgear 334 includes a main, or first strap member 336 having a first end 338, an opposite second end 340, and a mid portion 342 therebetween, and a second strap member 48 having a first end 50, an opposite second end 52 (not shown in FIG. 5), and a mid portion 54 therebetween adapted to be disposed on a patient generally as previously discussed in regard to FIGS. 2A and 2B. However, unlike the embodiments previously discussed, first strap member 336 includes a flared portion 350 preferably including an elongated cut out 352 disposed near first end 338 and another flared portion (not shown) also preferably including an elongated cutout similarly disposed near second end 340. Flared portion 350 (and elongated cut out 352) are adapted to engage the left cheek bone area of a patient (and similarly the another flared portion is adapted to engage the right cheek bone area) in a manner that generally grips the cheek bone of a patient and thus inhibits movement of first strap member 336, and thus headgear 330 and mask 32 with respect thereto.

[36] The purpose and advantage of the various straps and strap configurations shown in FIGS. 2-5 and described above are to enhance the stability of the patient interface device. That is each serves to minimize or prevent movement of mask 32 relative to the patient to maintain a seal over the airway of the patient. Each of the various straps and strap configurations shown in FIGS. 2-5 can be used alone or in combination with one or more of the other straps or strap configurations from these figures.

[37] FIGS. 6 and 7 illustrates a cross-sectional view of an exemplary

embodiment of a strap member 400 and 500, respectively, according to the principles of the present invention. In this embodiment the materials defining the strap are used to enhance the stability of the patient interface device. These material can be used alone or in combination with one or more of the other straps or strap configurations of FIGS. 2-5.

[38] As show in FIG. 6, strap member 400 includes a first layer 402 formed of a silicone or other suitable material and a second layer 404 formed of a different material, for example, without limitation, an open gel coating applied by a suitable application process (e.g., without limitation, spray-on, dipping, brush-on. First layer 402 generally serves as the structural part of the strap 400 while second layer 404 is adapted to contact the skin of the patient and can be selectively modified to provide added functionality to strap 400. For example, an open gel coating may be employed to encourage a desirable level of adhesion between strap member 400 and a particular area of the patient. In the example headgear described herein, such areas may include, for example, without limitation, one or more of the cheek area, the nose, the chin, and/or the forehead contacting portions.

[39] FIG. 7 illustrates a cross-sectional view of another exemplary embodiment of a strap member 500 according to the principles of the present invention that includes a first layer 502 formed of rubber or other suitable material and a second layer 504 formed of a different material, for example, without limitation, a fabric material applied by a suitable adhesion process. First layer 502 generally serves as the structural part of the strap 500 while second layer 504 is adapted to contact the skin of the patient to provide a more comfortable fit in areas where a non-slip fit are not needed (e.g., most areas aside from the cheek area, the nose, the chin, and/or the forehead contacting portions). The type of fabric employed as well as the thickness t thereof may be selectively varied to achieve other desired functionality (e.g., without limitation, cushioning, breathability, moisture absorption).

[40] The strap members described herein are preferably formed from silicone or other suitable material (e.g., without limitation, neoprene) unless otherwise particularly noted.

[41] In the claims, any reference signs placed between parentheses shall not be construed as limiting the claim. The word "comprising" or "including" does not exclude the presence of elements or steps other than those listed in a claim. In a device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements. In any device claim enumerating several means, several of these means may be embodied by one and the same item of hardware. The mere fact that certain elements are recited in mutually different dependent claims does not indicate that these elements cannot be used in combination.

[42] Although the invention has been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments, it is to be understood that such detail is solely for that purpose and that the invention is not limited to the disclosed embodiments, but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates that, to the extent possible, one or more features of any embodiment can be combined with one or more features of any other embodiment.

Claims

What is Claimed is:

1. A headgear (34, 134, 234) for use in securing a mask to the head of a patient, the headgear comprising:

a first strap member (36) having a first end, an opposite second end, and a mid portion therebetween, the first and second ends being adapted to be coupled to the mask, and the mid portion being adapted to engage an upper rear portion of the head of the patient when the mask and headgear are installed on the patient;

a second strap member (48) having a first end, an opposite second end, and a mid portion therebetween, the first end being coupled to a first side of the first strap member between the mid portion and the first end of the first strap member, the second end being coupled to a second side of the first strap member between the mid portion and the second end of the first strap member, and the mid portion being adapted to engage a mid portion of the rear of the head of the patient when the mask and headgear are installed on the patient; and

a third strap member (56, 156, 256) having a first end, an opposite second end, and a mid portion disposed therebetween, the first end of the third strap member being coupled to the first side of the first strap member, the second end being coupled to the second side of the first strap member, and the mid portion of the third strap member being adapted to engage one of the chin, nose, or forehead of the patient when the mask and headgear are installed on the patient.

2. The headgear of claim 1 , wherein the third strap member is adapted to engage the chin of the patient and wherein the first strap member and third strap member are integrally formed as a unitary member.

3. The headgear of claim 2, wherein the unitary member is formed of silicone material.

4. The headgear of claim 3, wherein the unitary member comprises a layer of a secondary material disposed thereon that is adapted to engage the chin of the patient.

5. The headgear of claim 4, wherein the unitary member comprises a layer of a secondary material disposed thereon that is adapted to engage the cheek of the patient.

6. The headgear of claim 1 , wherein the third strap member is adapted to engage the nose of a patient and wherein the first strap member and the third strap member are integrally formed as a single unitary member.

7. The headgear of claim 6, wherein the unitary member is formed of silicone material.

8. The headgear of claim 7, wherein the unitary member comprises a layer of a secondary material disposed thereon that is adapted to engage the nose of the patient.

9. The headgear of claim 8, wherein the unitary member comprises a layer of a secondary material disposed thereon that is adapted to engage the cheek of the patient.

10. The headgear of claim 1, wherein the third strap member is adapted to engage the forehead of a patient and wherein the second strap member and the third strap member are integrally formed as a single unitary member.

11. The headgear of claim 10, wherein the unitary member is formed of silicone material.

12. The headgear of claim 11, wherein the unitary member comprises a layer of a secondary material disposed thereon that is adapted to engage the forehead of the patient.

13. The headgear of claim 12, wherein the unitary member comprises a layer of a secondary material disposed thereon that is adapted to engage the cheek of the patient.

14. The headgear of claim 1, wherein the third strap member comprises a first material and a second material disposed on the first material in a manner such that the second material is adapted to engage the one of the chin, nose, or forehead of the patient when the mask and headgear are installed on the patient.

15. A headgear (34, 134, 234) for use in securing a mask to the head of a patient, the headgear comprising:

(a) a first strap member (36) comprising:

(1) a first end adapted to be coupled to the mask,

(2) an opposite second end adapted to be coupled to the mask;

(3) a mid portion disposed between the first end and the second end, the mid portion being adapted to engage an upper rear portion of the head of the patient when the mask and headgear are installed on the patient;

(4) a first flared portion disposed generally about the first end, the first flared portion adapted to engage the cheek bone area of the patient when the mask and headgear are installed on the patient; and

(5) a second flared portion disposed generally about the second end, the second flared portion adapted to engage the cheek bone area of the patient when the mask and headgear are installed on the patient; and

(b) a second strap member (48) having a first end, an opposite second end, and a mid portion therebetween, the first end being coupled to a first side of the first strap member between the mid portion and the first end of the first strap member, the second end being coupled to a second side of the first strap member between the mid portion and the second end of the first strap member, and the mid portion being adapted to engage a mid portion of the rear of the head of the patient when the mask and headgear are installed on the patient.

16. The headgear of claim 15, wherein each of the first flared portion and second flared portion comprise an elongated cut out area.

17. The headgear of claim 15, wherein the first strap member comprises a first material and a layer of a secondary material disposed thereon that is adapted to engage the cheek bone area of the patient.

18. The headgear of claim 16, wherein the first strap member comprises a first material and a layer of a secondary material disposed thereon that is adapted to engage the cheek bone area of the patient.