The present technology relates to air delivery conduits used in Positive Airway Pressure (PAP) systems for treatment, e.g., of Sleep Disordered Breathing (SDB) with Continuous Positive Airway Pressure (CPAP) or Non-Invasive Positive Pressure Ventilation (NIPPV).
PAP systems to deliver breathable gas to a patient typically include a positive airway pressure (PAP) device, an air or gas delivery conduit, and a patient interface. In use, the air delivery conduit delivers pressurized air or gas from the PAP device to the patient interface in contact with the patient's face.
The present technology provides improvements to known air delivery conduits to enhance comfort for the patient and/or lower manufacturing costs.
One aspect of the present technology relates to an air delivery conduit for use in the delivery of a supply of air or breathable gas to a patient, e.g., for treatment of respiratory disorders.
In an example, the air delivery conduit may have a generally D-shaped cross-section. In an example, a cross-section of the air delivery conduit may include a major axis and a minor axis.
In an example, the air delivery conduit may be constructed from polyethylene, polypropylene, EVA, or a blend of these materials.
In an example, the air delivery conduit has a first side adapted to be positioned against a face of a patient. In an example, the first side may be constructed and arranged to be substantially flat in cross-section. In an example, the first side may be constructed and arranged to be substantially parallel to a facial region of a patient in use. In an example, the first side may be constructed to be substantially free from corrugations. Preferably, the first side may be flexible. In an example, the first side may have a first stiffness.
In an example, the air delivery conduit includes a second side. In an example, the second side may includes one or more corrugations. In an example, the second side may be lengthwise extendible. Preferably, the second side may include a first region having a first pitch and second region having a second pitch. In an example, the conduit may vary in pitch between different regions. In an example, the second side may have a second stiffness that is less than the first stiffness.
In an example, the air delivery conduit may be constructed and arranged to flex while maintaining substantially patent. For example, the conduit may not include corrugations. In an example, the air delivery conduit may include structural reinforcement to reduce the tendency of the conduit to obstruct or collapse while bending.
In an example, the first side and the second side may be constructed from different materials, for example, a co-extrusion. In another example, the first side and the second side may be constructed from the same material, for example, a harder durometer and a softer durometer of the same material.
In an example, the air delivery conduit may be constructed and arranged to bend, flex and or be conformable to the shape of a patient's head in use.
Another aspect of the present technology relates to a method of manufacturing an air delivery conduit with an asymmetrical cross-sectional profile. In an example, the method includes an extrusion step followed by a blow-molding or vacuum forming step in one or more tools. In an example, a tool creates a corrugation on one side of an extruded tube, while creating a flat profile on another side of the extruded tube.
An advantage of an air delivery conduit or tube in accordance with one form of the present technology is that it is more comfortable for a patient compared to prior art designs. Another advantage of the present technology is that it may be constructed using a lower cost manufacturing process.
Another aspect of the present technology relates to an air delivery conduit including a tube including a plurality of corrugations, wherein the corrugations vary along a length of the tube to change flexibility and/or stretch characteristics of the tube in one or more specific zones.
Another aspect of the present technology relates to an air delivery conduit including a tube including a plurality of corrugations, wherein corrugations in a first zone of the tube have a first corrugation characteristic and corrugations in a second zone of the tube have a second corrugation characteristic that is different than the first corrugation characteristic.
Another aspect of the present technology relates to an air delivery conduit including a tube including a plurality of corrugations. A portion of the tube that includes the corrugations is asymmetric about at least one axis.
Other aspects, features, and advantages of this technology will become apparent from the following detailed description when taken in conjunction with the accompanying drawings, which are a part of this disclosure and which illustrate, by way of example, principles of this technology.
The accompanying drawings facilitate an understanding of the various examples of this technology. In such drawings:
The following description is provided in relation to several examples (most of which are illustrated, some of which may not) which may share common characteristics and features. It is to be understood that one or more features of any one example may be combinable with one or more features of the other examples. In addition, any single feature or combination of features in any example or examples may constitute patentable subject matter.
In this specification, the word “comprising” is to be understood in its “open” sense, that is, in the sense of “including”, and thus not limited to its “closed” sense, that is the sense of “consisting only of”. A corresponding meaning is to be attributed to the corresponding words “comprise”, “comprised” and “comprises” where they appear.
The term “air” will be taken to include breathable gases, for example air with supplemental oxygen.
One or more examples may include exemplary dimensions. Although specific dimensions and ranges may be provided, it is to be understood that these dimensions and ranges are merely exemplary and other dimensions and ranges are possible depending on application. For example, ranges that vary from those provided +/−10% may be suitable for particular applications.
A PAP system (e.g., CPAP system) typically includes a PAP device (including a blower for generating air at positive pressure), an air delivery conduit (also referred to as a tube or tubing), and a patient interface adapted to form a seal with the patient's face. In use, the PAP device generates a supply of pressurized air (e.g., 2-30 cm H2O) that is delivered to the patient interface via the air delivery conduit. The patient interface or mask may have suitable configurations as is known in the art, e.g., full-face mask, nasal mask, oro-nasal mask, mouth mask, nasal prongs, nozzles, cradle, etc. Also, headgear may be utilized to comfortably support the patient interface in a desired position on the patient's face.
In this example, the air delivery conduit is structured to be worn on the patient's head in use. For example, one or more of the air delivery conduits may be communicated with a patient interface to deliver breathable gas to the patient interface.
In one example, a pair of air delivery conduits may be communicated with the patient interface. In an example, as shown in
In another example, as shown in
In each example, each conduit is adapted to extend from adjacent to or under the patient's nose, over the patient's cheeks, between the patient's eye and ear, and terminate at the crown of the patient's head.
It should be appreciated that the air delivery conduit may be provided along the air delivery path in other suitable manners. For example, the air delivery conduit may be structured to extend from the inlet of the patient interface, over the nose and between the patient's eyes, and to a manifold or PAP device positioned adjacent the crown of the patient's head. It may also be possible to position the conduit along the patient's cheeks and under their ears to the back of their head. It is also possible for the conduit to be asymmetrical on the patient's head, e.g., extending from only one side of the patient interface.
Also, while the air delivery is described as being implemented into a CPAP system of the type described above, it may be implemented into other tubing arrangements for conveying gas or liquid. That is, the CPAP system is merely exemplary, and aspects of the present technology may be incorporated into other suitable arrangements.
In the illustrated example, as best shown in
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In the example, the tube is asymmetric about at least one axis, i.e., the major axis of the tube as shown in
The cross-sectional configuration is substantially constant along the length of the tube, e.g., tube size may vary due to corrugations discussed below. However, the generally D-shaped cross-section may vary along its length.
Also, it is possible for the wall thickness of the tube to vary around the perimeter, e.g., less thick on patient contacting side so that hardness is low, i.e., more comfortable, and thicker on non-patient contacting side to prevent kinking or occlusion. Alternatively, the tube may be thicker on the patient contacting side with low hardness material, e.g., 5 Shore A silicone, so that is it soft and gel-like on the patient's skin, and thinner on the non-patient contacting side to permit greater flex.
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In an alternative example, the inwardly facing surface may include a slight contour or curvature, e.g., to more closely follow a curvature of the patient's face in use.
In an example, the patient contacting side is substantially free from corrugations, i.e., in contrast to the non-patient contacting side which includes multiple corrugations as described below.
The patient contacting side may be flexible. In an example, the patient contacting side may have a first stiffness. For example, the patient contacting side may be made from a material having a Shore hardness of about 30-70 Shore A, e.g., preferably 30-50 Shore A. In an alternative example, the patient contacting side may have a relatively low hardness, e.g., as low as 5 Shore A, with additional reinforcement, e.g., one or more reinforcing ribs.
Also, the patient contacting side may be frosted to reduce friction and also enhance comfort and breathability. Alternatively, the patient contacting side may be grippy or sticky to ensure that the tube is in a stable position, e.g., made with a low durometer material that is tacky, e.g., 7 Shore A TPE, silicone. Also, one or more gripping members may be molded or otherwise provided to the patient contacting side, e.g., small dots made from a tacky material.
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In an example, a hydraulic diameter of about 15 mm may be preferred, e.g., optimized for impedance. However, it should be appreciated that tubes with a smaller hydraulic diameter are possible. In such tubing, means may be provided to reduce impedance, e.g., such as an active valve. If the hydraulic diameter is smaller, the perimeter and area may also reduce, but the general shape of the cross section may be the same.
The non-patient contacting side includes one or more corrugations, folds, grooves, and/or ridges. In the illustrated example, the non-patient contacting side includes a plurality of corrugations, and the corrugations vary along the length of the tube, e.g., to change the flexibility and/or stretch characteristics of the tube in one or more specific zones.
The corrugations are provided along the curved or contoured portion of the tube (non-patient contacting side), while no corrugations are provided are provided along the flat portion of the tube (patient contacting side). Thus, corrugations are only provided along a selected circumference of the tube, i.e., portion of tube circumference is corrugated and remaining portion of tube circumference is non-corrugated.
The corrugations are in the form of flexible ribbing that provide a series of parallel ridges/peaks 50 and grooves/valleys 55. The ridges 50 provide spaced-apart and parallel ring-like annular members along a length of the tube. That is, the ridges are generally straight, e.g., ridges extend generally perpendicular to a longitudinal axis of the tube. However, it should be appreciated that angled or spiral corrugations are possible.
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In an example, as shown in
The corrugations add rigidity and strength to the tube, with the corrugation characteristics selected to vary such rigidity and strength in different zones. In the illustrated example, the corrugations are smaller and closer together (smaller pitch) in the end zones Z2 which make the tube more flexible than the central zone Z1 in which the corrugations are larger and spaced farter apart (larger pitch). In use, as shown in
The corrugations also allow lengthwise extension of the tube, e.g., to allow lengthwise adjustment and/or flexibility of the tube. In an example, the corrugations may allow lengthwise extension in the range of about 60-100 mm.
In an example, the non-patient contacting side may have a second stiffness, which may be less than the first stiffness of the patient contacting side. For example, the non-patient contacting side may be made from a material having a Shore hardness of about 30-70 Shore A, e.g., preferably 50-70 Shore A. As noted above, the patient contacting side is preferably in the range of about 30-50 Shore A.
Also, it is possible for the tube to have alternative flexing means that are not corrugations, e.g., tube may be made from a material having alternative hardnesses or thicknesses along its length to increase flexibility in some regions more than others, e.g., high flexing regions made from 1 mm thick 30 Shore A silicone, and low flexing regions made from 5 mm thick 70 Shore A silicone, i.e., thickness and hardness of materials may be modified to achieve a similar affect.
In an example, the air delivery conduit may be constructed and arranged to bend, flex and/or be conformable to the shape of a patient's head in use. As described above, the conduit includes corrugations which may vary in different zones of the tube to vary flexibility.
In an example, the air delivery conduit may be constructed and arranged to flex while maintaining substantially patent. In an example, the air delivery conduit may include structural reinforcement (e.g., one or more internal ribs) to reduce the tendency of the conduit to obstruct or collapse while bending.
As noted above, each end of the air delivery conduit includes a cuff 20(1), 20(2) structured to attach the conduit to the patient interface, PAP device, etc. In the illustrated example, each cuff 20(1), 20(2) is similar to one another. However, it should be appreciated that the cuffs may be different from one another. In an alternative example, the cuffs may include sensors or electronics/wiring associated with heating for heated tubes.
Each cuff includes a larger width or diameter than the tube, e.g., for alignment and engagement with a respective tubular connector of the patient interface, PAP device, etc. In an example, as shown in
Also, as best shown in
In an example, as shown in
Also, each cuff 20(1), 20(2) and the region 25 adjacent each cuff between the cuff and end zone Z2 includes no corrugations. It should be appreciated that the length of the non-corrugated region 25 may be adjusted, e.g., to change the flexibility and/or stretch characteristics.
In an example, the conduit may include one or more structures to reduce noise in use. For example, the conduit may include insulation to reduce noise. For example, the insulation may be foam, fabric, foam and fabric, laminate, spacer fabric, and/or non-woven textile. The insulation may be provided to the inside or outside or combination of both on the tube. For example, the conduit may include an extra layer along its exterior surface to provide an insulating layer, or the conduit may include an extra layer along its interior surface to provide an insulating layer. Alternatively, an insulating layer may be molded into a thickness of the tube to insulate or reduce noise, e.g., a more rigid plastic may be insert molded into the tube to absorb noise.
Also, fewer or no corrugations may be provided along one or more zones of the conduit to reduce perceived noise, e.g., near the patient's ear. For example, see
In an example, the conduit may be molded from polyethylene, polypropylene, EVA, or a blend of these materials.
In an example, the patient contacting side and the non-patient contacting side may be constructed from different materials, e.g., a co-extrusion. In another example, the patient contacting side and the non-patient contacting side may be constructed from the same material, e.g., a harder durometer and a softer durometer of the same material.
Another aspect of the present technology relates to a method of manufacturing an air delivery conduit with an asymmetrical cross-sectional profile, e.g., D-shaped cross-section as described above. In an example, the method (also referred to a blow or vacuum corrugated extrusion) includes an extrusion step followed by a blow-molding or vacuum forming step in one or more tools. In an example, a tool or mold creates a corrugation on one side of an extruded tube, while creating a flat profile on another side of the extruded tube.
For example,
While the technology has been described in connection with several examples, it is to be understood that the technology is not to be limited to the disclosed examples, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the technology. Also, the various examples described above may be implemented in conjunction with other examples, e.g., one or more aspects of one example may be combined with aspects of another example to realize yet other examples. Further, each independent feature or component of any given assembly may constitute an additional example. In addition, while the technology has particular application to patients who suffer from OSA, it is to be appreciated that patients who suffer from other illnesses (e.g., congestive heart failure, diabetes, morbid obesity, stroke, bariatric surgery, etc.) can derive benefit from the above teachings. Moreover, the above teachings have applicability with patients and non-patients alike in non-medical applications.
Number | Date | Country | Kind |
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2010901460 | Apr 2010 | AU | national |
This application claims the benefit of Australian Provisional Application No. 2010901460, filed Apr. 7, 2010, which is incorporated herein by reference in its entirety.