WO2012028994A1

WO2012028994A1 - Patient interface with floating forehead pad

Info

Publication number: WO2012028994A1
Application number: PCT/IB2011/053707
Authority: WO
Inventors: Peter Chi Fai Ho
Original assignee: Koninklijke Philips Electronics N.V.
Priority date: 2010-09-02
Filing date: 2011-08-24
Publication date: 2012-03-08

Abstract

A pad (50, 150, 250, 450) for use with a gas deliver mask (10) in delivering a flow of gas to an airway of a patient. The gas delivery mask being secured to the patient by at least one strap (46). The pad includes a body portion (52) having a first end portion (54) and an opposite second end portion (56). The first and second end portions are structured to couple the pad to the strap of the gas delivery mask.

Description

PATIENT INTERFACE WITH FLOATING FOREHEAD PAD

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. 61/379,554 filed on September 2, 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 a pad for use with a support system for a gas delivery mask, and, more particularly, to a forehead pad for use with a forehead support system for a gas delivery mask for supplying a flow of gas 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 (NIV). It is also known to deliver continuous positive airway pressure (CPAP) or variable airway pressure, such as a bi-level pressure that varies with the patient's respiratory cycle or an auto -titrating pressure that varies with the monitored condition of the patient. Typical pressure support therapies are provided to treat a medical disorder, such as sleep apnea syndrome, in particular, obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), or congestive heart failure (CHF).

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

placement of a patient interface device, which is typically a nasal or nasal/oral mask, on the face of a patient to interface the ventilator or pressure support system 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 masks on the face of a patient by a headgear having upper and lower straps, each having opposite ends threaded through connecting elements provided on the opposite sides and top of a mask. [05] Because such masks are typically worn for an extended period of time, it is important the headgear maintain the mask in a tight enough seal against a patient's face without discomfort. A problem arises in that in order for the mask to maintain a seal without any undue gas leaks around the periphery of the mask, the mask may be compressed against the patient's face and thus be uncomfortable to the patient.

[06] It is known to provide forehead supports associated with gas delivery masks to provide a support mechanism between the mask and the patient's forehead. Gas delivery masks having forehead cushions, spacers or supports are described, for example, in U.S. Pat. Nos. 4,907,584; 5,243,971; 5,517,986; 5,570,689; 6,119,693 and 6,357,441. The forehead supports prevent the mask from exerting too much force on a patient's face at one general location by dispersing the load over a larger area, provide greater control of the force on the patient at certain pressure points, such as at the bridge of the nose, and provide stability to the mask. A forehead pad also serves to retain or lift the sealing cushion off the bridge of the nose, which is typically an area of the face in which the tissue of relatively delicate.

[07] Although these conventional patient interface devices have advanced the art, the need still exists for a patient interface device that improves upon existing devices, for example, to maximize patient comfort while minimizing leakage, during delivery of a positive airway pressure or flow of gas to the airway of the user. For example, many conventional patient interface devices tend to focus on minimizing the area of a patient's face to which strapping forces are applied. As such, a need exists for improved pad designs for use in such applications.

SUMMARY OF THE INVENTION

[08] Accordingly, it is an object of the present invention to provide an

improved patient interface device that overcomes the shortcomings of conventional patient interface devices. This object is achieved according to one embodiment of the present invention by providing a pad for use with a gas deliver mask in delivering a flow of gas to an airway of a patient, the gas delivery mask being secured to the patient by at least one strap. The pad includes a body portion having a first end portion and an opposite second end portion, the first and second end portions being structured to couple the pad to the strap of the gas delivery mask.

[09] In another embodiment, a method of providing a customizable pad for use with a gas deliver mask for delivering a flow of gas to an airway of a patient is provided. The method includes providing a pad comprising a body portion and a pillow member, the body portion having a first end portion and an opposite second end portion, the first and second end portions being structured to couple the pad to a strap of the gas delivery mask, and the pillow member having a housing disposed therein. The method further includes providing a plurality of support elements, each support element being disposable substantially within the housing of the pillow member.

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.

BRIEF DESCRIPTION OF THE DRAWINGS

[11] FIG. 1 is a perspective view of a mask and forehead support system

having a forehead pad according to the principles of an exemplary embodiment of the present invention shown (schematically) connected to a gas flow generating device;

[12] FIG. 2 is a partial side of the mask and forehead support system of FIG. 1;

[13] FIG. 3 is an exploded view of the mask and forehead support system of

FIG. 1;

[14] FIGS. 4-6 are views of forehead pads according to exemplary

embodiments of the invention;

[15] FIGS. 7-10 are views of a forehead pad according to another exemplary embodiment of the invention; and [16] FIGS. 11-13 are views of support elements according to exemplary embodiments of the invention that may be employed with the exemplary forehead pad shown in FIGS. 7-10.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

[17] 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. 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.

[18] 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). As employed herein, the terms "fastener" and "attachment mechanism" refer to any known or suitable securing mechanisms for securing one part to another part, and expressly include, but are not limited to mechanical mechanisms, Velcro, snaps and adhesives.

[19] 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 [20] FIGS. 1-3 illustrate an exemplary embodiment of a gas delivery mask 10 according to the principles to the present invention. Gas delivery mask 10 functions as a patient interface device to communicate a flow of breathing gas between a patient's airway and a pressure generating device 12 (shown schematically), such as a ventilator, CPAP device, autotitrating CPAP device, PPAP, PAV®, or variable pressure device, e.g. a BiPAP® device manufactured and distributed by Philips Respironics, Inc. of

Pittsburgh, Pa., in which the pressure provided to the patient varies with the patient's respiratory cycle so that a higher pressure is delivered during inspiration than during expiration.

[21] Referring to FIGS. 1-3, there is illustrated a patient interface device in the form of a gas delivery mask 10 for delivering a flow of gas to an airway of a patient. Gas delivery mask 10 includes a mask shell 14 or body portion which can be, but not necessarily need be, a generally rigid, formed structural shell having an open side that defines an annular portion 16 to which a resilient, relatively soft cushion or seal member 18 is attached. In the illustrated exemplary embodiment, mask shell 14 is substantially triangular in shape, having an upper apex angle 20 and two lower angles 22. Mask shell 14 includes an inlet opening 24 adapted to receive a gas supply conduit 26 (shown schematically). In an exemplary embodiment, mask shell 14 is formed from rigid plastic, such as Polycarbonate. Seal member 18 is configured to receive a portion of the patient, such as the nose.

[22] The mask illustrated in FIGS. 1 to 3 is a typical nasal mask. It is however to be appreciated that the invention can be used on any mask interface either nasal, oral, oral-nasal, nasal cannula, or nare as long as the mask employs separate support or supports that contact any part of the face other than the sealing area. It is to further be appreciated that although the exemplary embodiment shown in the figures is a forehead pad, which is conventionally placed above the cushion (sealing element) on the forehead of a patient, the invention may be employed in other suitable locations.

[23] In the illustrated exemplary embodiment, a lower headgear connector assembly 28 includes a pair of first connectors 30 rigidly attached to lower angles 22 of mask shell 14. Lower headgear straps (not shown) in headgear assembly are selectively connected to mask 10 by means of a second connector 32. In the illustrated embodiment, a pair of second connectors 32, are removably connectable to end portions of headgear straps (not shown) and are also removably connectable to first connectors 30 on each side of mask shell 14. Alternately, lower headgear connector assembly 28 can be any suitable headgear connector assembly.

[24] Likewise, the present invention contemplates the headgear can be any suitable headgear, i.e., any conventional headgear used in the patient interface field. For example, a typical headgear assembly comprises a headpiece (not shown) that overlies a portion of the patient's crania and with a pair of lower headgear straps and a pair of upper headgear straps extending therefrom to adjustably connect the headgear to the mask.

[25] A forehead support 34, according to the illustrated exemplary

embodiment, is provided at upper apex angle 20. Forehead support 34, in this embodiment, is generally T-shaped and includes a support arm 36 which is connected at its upper end 38 (FIG. 2) to a horizontal forehead support bracket 40. A forehead pad 50, discussed in further detail below, is disposed adjacent to, but not directly coupled to, forehead support bracket 40, generally between forehead support bracket 40 and the forehead of the patient. Each end portion 42 of forehead support bracket 40 may include a connector element for securing the end portion to an upper headgear strap 46. In the embodiment depicted in FIGS. 1 -3, such a connector element is a female receiving slot (first mask slot) into which the headgear strap is inserted and then looped back through the slot in the end portion of forehead pad 50. However, it should be apparent that other connection mechanisms could be used for joining the headgear strap to the forehead support bracket. For example, a male quick release element can be provided on upper headgear strap 46 that attaches to a corresponding female quick release element provided on each end portion 42 of forehead support bracket 40.

[26] Due to its placement, forehead pad 50 rests against the forehead of the patient (shown in phantom line in FIG. 2) and forehead support bracket 40 rests against forehead pad 50. In an exemplary embodiment, forehead pad 50 is formed of a soft cushioning material in order to provide maximum comfort to a user. Referring to FIG. 3, forehead pad 50 includes an elongated main body portion 52 having a first end portion 54 and an opposite second end portion 56. As shown in FIG. 1 , the first and second end portions 54, 56 are structured to slidably couple forehead pad 50 to upper headgear strap 46 of mask 10. Such slidable coupling of end portions 54, 56 eliminates any need to couple forehead pad 50 to forehead support bracket 40. Accordingly, it is to be appreciated that forehead pad 50 is provided with the ability to move relative to forehead support bracket 40, thus providing greater comfort to the user as the user may adjust the location of the pad relative to one or more of the user's forehead and forehead support bracket 40. As depicted in FIGS. 1-3, forehead pad 50 may, for example, without limitation, be formed of a fabric main body portion 52 having one or more pads (not shown) of suitable cushioning material (e.g., without limitation, silicone) sewn, or otherwise coupled thereto.

[27] FIG. 4 shows an example embodiment of a forehead pad 150 in

accordance with the present invention. Forehead pad 150 includes a main body portion 152 bounded by a first end portion 154 having a slot 155 formed therein and an opposite second portion 156 also having a slot 157 formed therein such that first and second end portions 154, 156 generally form loop members. Each of slots 155, 157 are of such suitable size and shape to allow a strap member, such as strap member 46 previously discussed, to freely pass therethrough. First and second end portions 154, 156 may be formed by over-molding, bonding, or other suitable manufacturing methods and may be formed from different material than main body portion 152. In an exemplary

embodiment, end portions 154, 156 are formed from a rigid or semi rigid plastic material while main body portion 152 is formed from a soft rubbery material (e.g., without limitation, silicone), however end portions 154, 156 may also be formed integrally with main body portion 152.

[28] FIG. 5 shows another example embodiment of a forehead pad 250 in accordance with the present invention. Forehead pad 250 is similar to forehead pad 150 previously discussed except first and second end portions 254, 256 are generally formed in the shape of hook members, each having an opening 255, 257 through which a strap may pass. It is to be readily appreciated that such hook shapes allow for the quick removal and/or reattachment of forehead pad 250 from support straps, such as strap members 46 of FIG. 1.

[29] FIG. 6 shows a further example embodiment of a forehead pad 350 in accordance with the present invention. Similar to forehead pads 50, 150, and 250, previously discussed, forehead pad 350 includes a main body portion 352 having first and second end portions 354-356 that are structured to slidably couple forehead pad 350 to strap members. Forehead pad 350 may be of similar form and construction of any of forehead pads 50, 150, and 250 as previously discussed, with the addition of a forehead engaging cushion member 358 formed as an integral portion of, or a separate member coupled to, main body portion 352. Cushion member 358 may be coupled to main body portion by mechanical coupling such as snap fit or friction fit, adhesion, over-molding, or other suitable method. In an exemplary embodiment, cushion member 358 has a generally hollow springy structure formed from a rubbery material such as silicone or thermoplastic elastomer (TPE) or other suitable material, which is may be substantially impermeable to moisture. In this manner, cushion member 358 is relatively easy to wipe clean, and also resists the undesired entry of moisture therein.

[30] FIGS. 7-10 show views of a further embodiment of a forehead pad 450 of similar construction to that of forehead pad 350 previously discussed. As such, forehead pad 450 includes a main body portion 452 having first and second end portions 454, 456 and a cushion member 458 coupled thereto. However, unlike the embodiments previously discussed, cushion member 458 of forehead pad 450 includes a housing portion 460 (shown in hidden line in FIG. 9 and generally in FIG. 10) within cushion member 458. Cushion member 458, and, thus, housing portion 460, is formed from a slightly curved first wall 468 structured to contact the patient, and a second wall 470, generally curved a greater amount than first wall 468. Second wall 470 is coupled to main body portion 452 thus coupling cushion member 458 and main body portion 452 together. In the exemplary embodiment depicted in FIGS. 7-10, main body portion 452 and cushion member 458 are formed as a unitary member, however it is to be appreciated that main body portion 452 and cushion member 458 could be formed separately without varying from the scope of the present invention. [31] As shown in FIG. 10, in an exemplary embodiment, an opening 462 providing access to housing portion 460 is formed in main body portion 452. Housing portion 460 allows for a support element, such as one of those depicted in FIGS. 11-13, to be inserted into cushion member 458. FIGS. 11 and 12 show an exemplary support element 480 according to an embodiment of the invention in which support element 480 is custom formed from a "closed" cell skinned foam material, such as a silicone-foam material, formed to cooperatively fit within housing portion 460 of cushion member 458. The flexible nature of cushion member 458 and support element 480 allow for the insertion of support element 480 into cushion member 458 via opening 462. Once installed, cushion member 458 substantially surrounds support element 480. In an exemplary embodiment, a silicone-foam material having a density (pcf) of about 14.5, a softness (Shore ΌΟ') of about 20-25, and an average cell size (mm in diameter) of about 0.5 (fairly uniform ranging from about 0.2 to 0.8) in open cell structure, has been employed. In another exemplary embodiment, a polyurethane foam (either Ester or Ether) having a density (pcf) of about 8.5, a softness (Shore ΌΟ') of about 20-25, and an average cell size (mm in diameter) of about 0.5 (fairly uniform ranging from about 0.2 to 0.8) in open cell structure, has been employed.

[32] As an alternative to the use of formed "closed" cell skinned materials for support element 480 as described above, support element 480 may also be formed from an "open" cell soft foam material such as, for example without limitation, any non structural foam with compression and expansion capability, typical materials are Polystyrene and Polyurethane. Such "open" cell foam material may be die cut, such as shown by support element 480' of FIG. 13. Alternatively, such "open" cell material may be suitably formed to have a desired shape, such as, for example without limitation, the shape of support element 480 of FIGS. 1 1 and 12. In either case, the rather soft nature of support element 480' will generally result in support element 480' contouring to the shape of housing portion 460.

[33] It is to be appreciated that in addition to the exemplary embodiments described herein, support element 480 may also be formed from any suitable resilient cushioning material, and may include, for example and without limitation, more than one element and/or different sizes or variations of elements formed from alternative materials, such as gel, foam, silicone, or viscoelastic foam or memory foam. Additionally, the selection of the particular material employed as support element 480 or, at minimum, particular attributes of the material, may be left up to the end user (patient) to allow for custom tailoring of forehead pad 450 by the patient. In such instances, a number of different types of interchangeable support elements 480 would be supplied from which the patient could pick and choose as desired to customize the feel of forehead pad 450 as desired.

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 pad (50, 150, 250, 450) for use with a gas deliver mask (10) in delivering a flow of gas to an airway of a patient, the gas delivery mask being secured to the patient by at least one strap, the pad comprising:

a body portion (52) having a first end portion (54) and an opposite second end portion (56), the first and second end portions being structured to couple the pad to the strap of the gas delivery mask.

2. The pad of claim 1 , wherein at least one of the first and second end portions (154,156) comprise a loop member that is structured to completely surround the strap.

3. The pad of claim 2, wherein the loop member is integrally formed with the body member or is a separate member coupled to the body member.

4. The pad of claim 1 , wherein at least one of the first and second end portions (254, 256) comprise a hook member that is structured to almost completely surround the strap member.

5. The pad of claim 4, wherein the hook member is integrally formed with the body member.

6. The pad of claim 4, wherein the hook member is a separate member coupled to the body member.

7. The pad of claim 1 , wherein the body member comprises a pillow member.

8. The pad of claim 7, wherein the pillow member (458) comprises a housing (460) disposed therein.

9. The pad of claim 8, wherein the housing (460) comprises a support element (480) disposed substantially therein.

10. The pad of claim 9, wherein the support element (480') comprises an open cell foam material.

11. The pad of claim 9, wherein the support element (480) comprises a closed cell foam material.

12. The pad of claim 9, wherein the pillow member (458) is formed from a silicone or thermoplastic elastomer material.

13. A patient interface device (10) comprising:

a gas deliver mask (10) including a first mask slot and a second mask slot; a pad (50, 150, 250, 450) including a body portion (52) having a first end portion (54) and an opposite second end portion (56); and

a strap (4) adapted to be inserted into the fist mask slot and the second mask slot and is operatively coupled to the first end portion and the second end portion.

14. The patient interface device of claim 13, wherein the first and the second end portions (154,156) comprise a first loop member and a second loop member, and wherein the first loop member and the second loop member are structured to completely surround the strap.

15. The patient interface device of claim 14, wherein the loop member is integrally formed with the body member or is a separate member coupled to the body member.