Nasal pillow cushion for patient interface device

Abstract

A cushion (16) for providing a respiratory therapy regimen to a patient includes a base defining a main cavity and an orifice for receiving a flow of breathing gas therein. A pair of nasal pillows (48) each extend from the base (40), each having a tapered head portion tapering inwardly and upwardly from a base portion extending directly from the base to a top opening (54). Each head portion is formed to engage an interior of a patient's nare. Each head portion defines a passageway extending between the main cavity and the top opening for further communicating the flow of breathing gas from the main cavity to a patient's nasal passage. Each base portion includes an inner edge (52A) positioned proximate a center of the cushion merging with the hollow base and an opposite outer edge (52B) spaced upwardly from an outer surface of the hollow base (40).

Description

[0001] Cross-reference to related applications

[0002] This patent application claims priority to U.S. Provisional Application No. 62 / 907186, filed September 27, 2019, the contents of which are incorporated herein by reference. Technical Field

[0003] The present invention generally relates to a patient interface device used in a pressure support system that provides airflow to a patient's airway, and more specifically, to a nasal pillow pad for such a patient interface device. Background Technology

[0004] Obstructive sleep apnea (OSA) is a problem affecting millions of people worldwide. OSA is characterized by disordered or interrupted breathing during sleep. An OSA attack occurs when there is partial or complete obstruction of airflow during sleep, lasting at least 10 seconds and often up to 1 to 2 minutes. In a given night, people with moderate to severe sleep apnea may experience up to 200-500 episodes of complete or partial breathing interruption per night. Because their sleep is frequently interrupted, they are deprived of restorative sleep necessary for efficient physical and mental function. This sleep disorder is also associated with high blood pressure, depression, stroke, arrhythmia, myocardial infarction, and other cardiovascular diseases. OSA also causes excessive fatigue.

[0005] One treatment for OSA is positive airway pressure (PAP) therapy. Known PAP therapies include continuous positive airway pressure (CPAP), which provides a constant positive airway pressure to the patient's airway to open it using a splint; and variable airway pressure, where the pressure provided to the patient's airway varies with the patient's respiratory cycle. This therapy is typically administered to the patient while they are sleeping at night.

[0006] The non-invasive ventilation and pressure support therapy just described involves placing a patient interface device, typically a nasal mask or nasal / mask, on the patient's face to interface the ventilator or pressure support system with the patient's airway so that respiratory airflow can be delivered from the pressure / flow generation device to the patient's airway.

[0007] Because patient interface devices are typically worn for extended periods, a variety of issues must be considered. For example, in providing CPAP for OSA treatment, patients often wear the device overnight while they sleep. In this case, one issue is ensuring the device is as comfortable as possible; otherwise, the patient may avoid wearing it, negating the intended purpose of pressure support therapy. Another issue is that an improperly fitted device can create gaps between the device and the patient, leading to unwanted leaks. Therefore, selecting a properly fitted patient interface device is crucial.

[0008] One type of patient interface device is the nasal pillow mask. Typically, nasal pillow masks utilize a silicone sealing pad with a pair of heads, each head being frustoconical, inserted into the corresponding nostril of the patient and sealing the inner and outer surfaces of the nostril opening. Current designs also include a hollow rod, connected at one end to the bottom of the conical head and extending at the other end to an elastic base membrane, thus separating the entire conical head from the base membrane. When the patient inhales, air travels from the pad base, through the cylindrical rod, and into the head. The rod allows the conical head to move and rotate relative to the pad base, improving the pad's ability to adapt to changes in the patient's facial geometry and allowing the conical head to remain in contact with the patient's nose even with slight movement of the pad base (e.g., when the patient turns over in bed, the pad base comes into contact with the bedding). The rods in current pillow designs allow the head to hinge relative to the pad base, but they also have some drawbacks. For example, the rods add extra size, volume, and weight to the pad. This is particularly problematic because nasal pillow masks are often constructed as the smallest / lightest masks on the market. The rods also add additional airflow resistance. The small diameter of the cylindrical rod increases airflow resistance and reduces the patient's breathing comfort.

[0009] For example, U.S. Patent Application No. 2006 / 266361 discloses a ventilation interface device that may include a hollow sleeve, at least one nasal insert, and at least one exhaust port, or may include a mask designed to cover the user's nose, mouth, or both. The at least one nasal insert may be formed to fit any size nostril for any user and may be removable. Furthermore, the at least one exhaust port may be in any of a variety of orientations, and in some embodiments, includes a sealable port. Summary of the Invention

[0010] As one aspect of the invention, a pad for providing a respiratory therapy to a patient includes: a hollow base defining a main cavity therein, the hollow base defining at least one aperture for receiving a respiratory airflow generated by a pressure generating device; a pair of nasal pillows, each nasal pillow extending from the hollow base, each nasal pillow having a generally conical head that tapers inward and upward from a base portion extending directly from the base to a top opening, wherein each conical head is configured to sealably engage the interior of a patient's nostril, the top opening of the conical head being positioned within the patient's nostril, wherein each conical head defines a passage extending therethrough between the main cavity and the top opening and is configured to further deliver a respiratory airflow from the main cavity to the patient's nasal passage, and wherein each base portion includes an inner edge and an opposing outer edge, the inner edge being positioned near the center of the pad merged with the hollow base, the outer edge being disposed outside the pad and spaced upward from the outer surface of the hollow base by a distance.

[0011] Each base section can be positioned at an angle relative to the central reference plane that divides the pad in two, and this angle can be in the range of 45 degrees to 90 degrees.

[0012] The hollow base and the pair of nose pillows can each be a single unit component.

[0013] The area where the inner edge of each base portion merges with the hollow base can be at least one of the following: a thickness thinner than the wall of the adjacent hollow base, or formed of a softer material than the adjacent hollow base.

[0014] At least one aperture may include a first aperture disposed at a first end of the hollow base and a second aperture disposed at the opposite second end of the hollow base.

[0015] Each conical head may include multiple ribs, each rib extending partially from the inner surface of the conical head into a channel defined in the head.

[0016] As another aspect of the invention, a patient interface device for providing a respiratory therapy protocol to a patient includes: a frame configured to be coupled to a patient's head via a headpiece; and a pad coupled to the frame, the pad including: a hollow base defining a main cavity therein, the base defining at least one aperture for receiving a respiratory airflow generated by a pressure generating device; a pair of nasal pillows, each nasal pillow extending from the hollow base, each nasal pillow having a generally conical head that tapers inward and upward from a base portion extending directly from the hollow base to a top opening, wherein each conical head is configured to sealably engage the interior of a patient's nostril, the top opening of the conical head being positioned within the patient's nostril, wherein each conical head defines a passage extending therethrough between the main cavity and the top opening and being configured to further deliver a respiratory airflow from the main cavity to the patient's nasal passage, and wherein each base portion includes an inner edge and an opposing outer edge, the inner edge being positioned near the center of the pad merging with the hollow base, and the outer edge being disposed outside the pad and spaced upward from the outer surface of the hollow base by a distance.

[0017] Each base section can be positioned at an angle relative to the central reference plane that divides the pad in two, and this angle can be in the range of 45 degrees to 90 degrees.

[0018] The hollow base and the pair of nose pillows can each be a single unit component.

[0019] The area where the inner edge of each base portion merges with the base can be at least one of the following: a thickness thinner than the wall of the adjacent hollow base, or formed of a softer material than the adjacent hollow base.

[0020] At least one aperture may include a first aperture disposed at a first end of the hollow base and a second aperture disposed at the opposite second end of the hollow base.

[0021] Each conical head may include multiple ribs, each rib extending partially from the inner surface of the conical head into a channel defined in the head.

[0022] As another aspect of the invention, a system suitable for providing a respiratory therapy to a patient includes: a pressure generating device configured to generate a respiratory airflow; a delivery conduit having a first end coupled to the pressure generating device and having an opposing second end; and a patient interface device including: a frame configured to be coupled to a patient's head via a headpiece; and a pad coupled to the frame, the pad including: a hollow base defining a main cavity therein, the hollow base defining at least one aperture for receiving the respiratory airflow generated by the pressure generating device from the second end of the delivery conduit; and a pair of nasal pillows, each nasal pillow extending from the hollow base, each nasal pillow having a generally conical head. The head tapers inward and upward from a base portion extending directly from the hollow base to a top opening, wherein each conical head is configured to seal into the interior of the patient's nostril, the top opening of the conical head being positioned within the patient's nostril, wherein each conical head defines a passage extending therethrough between the main cavity and the top opening, and is configured to further deliver airflow from the main cavity to the patient's nasal passage, and wherein each base portion includes an inner edge and an opposing outer edge, the inner edge being positioned near the center of the pad merging with the hollow base, the outer edge being disposed outside the pad and spaced upward from the outer surface of the hollow base by a certain distance.

[0023] At least one aperture may include a first aperture disposed at a first end of the hollow base and a second aperture disposed at the opposite second end of the hollow base.

[0024] Each conical head may include multiple ribs, each rib extending partially from the inner surface of the conical head into a channel defined in the head.

[0025] These and other objects, features, and characteristics of this disclosure, as well as the methods of operation and function of the related elements of the structure, and the economy of combination and manufacture of the components, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which constitute a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. However, it should be clearly understood that the drawings are for illustrative and descriptive purposes only and are not intended to be construed as limiting the invention. Attached Figure Description

[0026] Figure 1This is a partial schematic perspective view of a system suitable for providing a respiratory therapy protocol to a patient according to an exemplary embodiment of the present invention, the system including a patient interface device with a pad;

[0027] Figure 2 yes Figure 1 A front perspective view of the pad;

[0028] Figure 3 yes Figure 1 A top view of the pad;

[0029] Figure 4 yes Figure 1 Front elevation view of the pad;

[0030] Figure 5 It is along Figure 3 The line cut from 5-5 Figure 1 Elevation section view of the pad;

[0031] Figure 6 yes Figure 1 Rear elevation view of the pad;

[0032] Figure 7 yes Figure 1 Side elevation view of the pad;

[0033] Figure 8 It is along Figure 6 The line cut from 8-8 Figure 1 The elevation section of the pad; and

[0034] Figure 9 This is a partial schematic perspective view of another system adapted to provide a respiratory therapy protocol to a patient, according to an exemplary embodiment of the present invention, the system including a patient interface device with another pad. Detailed Implementation

[0035] As used herein, the singular forms of “a,” “an,” and “the” include plural references unless the context clearly indicates otherwise. As used herein, the expression “coupled” for two or more parts or components shall mean that these parts are directly or indirectly (i.e., through one or more intermediate parts or components) coupled or operate together, provided that an association exists. As used herein, “direct coupling” means that two elements are in direct contact with each other. As used herein, “fixed coupling” or “fixed” means that two components are coupled so as to act as a movement while maintaining a constant orientation relative to each other.

[0036] As used herein, the expression “engage” between two or more parts or components shall mean that these parts exert force on each other directly or through one or more intermediate parts or components. As used herein, the term “number” shall mean an integer of one or more (i.e., a plurality). Directional phrases used herein, such as, for example but not limited to, left, right, up, down, front, back, above, and their derivatives, relate to the orientation of the elements shown in the figures and do not limit the claims unless expressly stated therein. As used herein, the term “and / or” shall mean one or both of the elements separated by such a term. For example, “A and / or B” would mean any one of: i) A, ii) B, or iii) A and B.

[0037] exist Figure 1 The image generally illustrates a system 2 suitable for providing a respiratory therapy protocol to a patient according to an exemplary embodiment of the present invention. System 2 includes a pressure generating device 4 (shown schematically), a delivery catheter 6 (shown schematically), a patient interface device 8 having a fluid coupling catheter 10 coupled via a catheter segment 12, and a headgear (only its strap 14 is shown). The pressure generating device 4 is configured to generate a respiratory airflow and may include, but is not limited to, a ventilator, a constant pressure support device (such as a continuous positive airway pressure device, i.e., a CPAP device), or a variable pressure device (e.g., manufactured and distributed by Philips Respironics of Murrisville, Pennsylvania). Or C-Flex TM The device includes an automatic titration pressure support device. The delivery catheter 6 is configured to transmit respiratory airflow from the pressure generating device 4 to the patient interface device 8 via a fluid-coupled catheter 10 and catheter segment 12. Figure 1 In the exemplary embodiment shown, the fluid coupling catheter 10 is a straight connector; however, it should be understood that other suitable couplings may be used without departing from the scope of the invention. It should also be understood that, without departing from the scope of the invention, catheter segment 12 may be omitted, thus the delivery catheter 6 is directly connected to the patient interface device 8, or connected via the aforementioned coupling. The delivery catheter 6 and the patient interface device 8 are generally referred to collectively as the patient circuit.

[0038] The device is a two-layer device in which the pressure delivered to the patient varies with the patient's respiratory cycle, thus delivering a higher pressure during inspiration than during expiration. An automatically titrated pressure support system is a system where the pressure varies with the patient's condition, such as whether the patient snores or experiences apnea or hypopnea. For the present purpose, the flow / pressure generating device 4 is also referred to as an airflow generating device because flow is generated when a pressure gradient is created. The present invention is contemplated that the flow / pressure generating device 4 is any conventional system for delivering airflow to a patient's airway or for increasing the gas pressure at the patient's airway, including the pressure support systems and non-invasive ventilation systems summarized above.

[0039] Continue to refer to Figure 1 The patient interface device 8 includes a pad 16 coupled to a frame 18 via a magnetic device, which will be discussed further below. The pad 16 can be formed of any flexible material (e.g., but not limited to silicone). The frame 18 can be formed of a substantially rigid material (e.g., but not limited to one or more plastics). The frame 18 includes a central portion 20, which is formed as an generally thin member having a patient-facing side 22 and an opposing outward-facing side 24. The central portion 20 is curved such that the patient-facing side 22 is generally concave, while the outward-facing side 24 is generally convex. The frame 18 also includes: a first wing 26 extending generally from a first end 28 of the central portion 20 in a slightly tapering manner to a first distal end 30; and a second wing 32 extending generally from a second end 34 of the central portion 20 in a slightly tapering manner to a second distal end 36. Figure 1 In the example embodiment shown, each of the first wing 26 and the second wing 32 is offset from the patient-facing side 22 of the central portion 20 by a certain distance via a corresponding spacer portion, the spacer portion being narrower than the portion of the central portion 20 and the wings 26 and 32 adjacent to the spacer portion.

[0040] Each wing 26 and 32 is configured to cooperatively engage a corresponding headband of the headband 14 in a manner that secures each strap 14 to the frame 18. More specifically, each strap 14 is formed of an elastic fabric material and is typically a flat tubular member having a closed end 14A. An aperture is defined in each strap 14, providing an entrance to the interior of each flat tubular member at a distance from its closed end 14A. To secure the strap 14 to the frame 18, the distal portion 30 of the wing 26 is inserted into the aperture of one of the straps 14. The aperture is then slid along the wing 26 until the outward-facing portion of the aperture's periphery contacts the spacer portion. At this point, a large portion of the wing 26 is positioned within the flat tubular member that serves as the strap 14. The aperture then extends generally around the remaining portion of the wing 26 such that the previously remaining portion of the wing 26 is positioned within the portion of the flat tubular member generally between the aperture and the sealing end 14A. When fully installed, the aperture of band 14 is arranged to surround the spacer portion between the central portion 20 and the wing 26. Another band 14 is similarly secured to the frame 18 by repeating the same steps on the second wing 32.

[0041] Now for reference Figures 2-8 The details of pad 16 will now be described. Pad 16 includes a generally hollow base 40, in which a main cavity 42 is defined. The base 40 includes at least one aperture 44 for receiving a breathing airflow generated by the pressure generating device 4 into the main cavity 42, as previously described. Figure 1 The subject of discussion. Figures 1-8 In the example embodiment shown, the base 40 includes a plurality of magnetic elements 46 disposed thereunder, these magnetic elements 46 being positioned to magnetically couple to corresponding magnetic elements provided in the frame 18 in order to selectively couple the pad 16 to the frame 18, such as Figure 1 As shown in the image.

[0042] Continue to refer to Figures 2-8 The pad 16 also includes a pair of nasal pillows 48, each extending directly from the base 40. More specifically, each nasal pillow 48 includes a generally conical head 50 that tapers inward (without flaring outward) and upward from the base portion 52 (extending directly from the base 40) to a top opening 54. Each conical head 50 is tapered to be formed to seal against the interior of the patient's nostril, with its top opening 54 positioned within the patient's nostril. Each conical head 50 defines a passage 56 extending therethrough between the main cavity 42 and the top opening 54, and is configured to further direct airflow from the main cavity 42 into the patient's nasal passage. Figure 5 and Figure 8As shown in the cross-sectional view, each nasal head 48 may include one or more ribs 58 that extend partially from the inner surface of each conical head 50 into a channel 56 defined within the head, in a direction generally perpendicular to the inner surface of each conical head 50. These ribs 58 serve to reinforce each conical head 50 to resist collapse upon contact with the patient's nostrils. These ribs 58 are advantageous for this purpose (e.g., compared to thickening the walls or using a stiffer material) because they selectively stiffen the head to prevent collapse while still allowing the head to deform circumferentially to conform to the shape of the nostrils. The ribs 58 may be spaced apart around the inner periphery of each conical head 50. In the example embodiment, the ribs 50 are spaced apart from portions of each conical head 50 configured to engage at or near the patient's nasal septum, as this area is typically sensitive and therefore does not wish to be stiffened.

[0043] As previously described, each base portion 52 extends directly from the base 40. More specifically, each base portion 52 includes an inner edge 52A positioned near the center of the pad 16 and merging with the outer surface 40A (and wall) of the base 40. Each base portion 52 also includes an outer edge 52B opposite to the inner edge 52A, spaced apart from the outer surface 40A of the base 40 by a distance d. Figures 4-6 As shown, each base portion 52 is generally positioned at an angle θ relative to the central reference plane P that divides the pad 16 in two. In an exemplary embodiment of the invention, base portions 52 are oriented at an angle θ between 30 and 135 degrees; however, for most applications, an angle θ between 45 and 90 degrees is generally found to be optimal. Figures 1-8 In the example embodiment shown, the pad 16 is formed as a monolithic element from an elastic material (e.g., but not limited to silicone). However, it should be understood that, without departing from the scope of the invention, the pad 16 may be formed as a modular element having components formed from any suitable one or more materials.

[0044] From the foregoing example, it should be understood that the intersection between each inner edge 52A of each base portion 52 and the base 40 forms a hollow hinge, which allows each conical head 50 to hinge relative to the base 40 without the use of a rod portion as described in the background section of this document. This intersection between the base portion 52 and the base 40 can be formed of a thinner amount of material than the surrounding portions and / or can be formed of a softer material to further enhance the hinge capability of each head 50. This design provides a lighter and more streamlined pad 16 than conventional designs.

[0045] Figure 9The illustration shows a partial schematic diagram of another system 2' adapted to provide a respiratory therapy to a patient according to an exemplary embodiment of the invention. System 2' includes a patient interface device 8' having another pad 16'. Pad 16' has a similar construction to the previously discussed pad 16 and therefore includes a generally hollow base 40' defining a main cavity (unnumbered) therein. Base 40' includes: a first aperture 44' disposed at a first end of base 40' for receiving a respiratory airflow generated by pressure generating device 4; and a second aperture 44'" disposed at the opposite second end of base 40', which is also configured to receive a respiratory airflow generated by pressure generating device 4. Pad 16' also includes, as previously discussed... Figures 1-8 The nose pillows discussed are a pair of nose pillows 48, which are positioned relative to the base 40' in a similar manner to that previously discussed with respect to the base 40. From this additional example, it should again be understood that this design provides a lighter and more streamlined pad 16' than conventional designs.

[0046] In the claims, any reference numerals placed between parentheses should not be construed as limiting the claims. The words "comprising" or "including" do not exclude the presence of elements or steps other than those listed in the claims. In device claims listing multiple components, some of these components may be implemented by the same hardware item. The words "a" or "an" preceding an element do not exclude the presence of a plurality of such elements. In device claims listing multiple components, some of these components may be implemented by the same hardware item. The mere fact that certain elements are recited in mutually different dependent claims does not imply that these elements cannot be used in combination.

[0047] While the invention has been described in detail based on embodiments currently considered most practical and preferred for illustrative purposes, it should be understood that these details are for illustrative purposes only, and the invention is not limited to the disclosed embodiments, but rather is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the 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

1. A pad (16) for providing a respiratory therapy protocol to a patient, said pad comprising: A hollow base (40) defines a main cavity (42) therein, the hollow base defining at least one aperture for receiving a breathing airflow generated by a pressure generating device; as well as A pair of nose pillows (48), each extending from the hollow base, each nose pillow having a generally conical head (50) that tapers inward and upward from a base portion (52) extending directly from the base to a top opening (54). Each conical head is configured to seal into the interior of the patient's nostril, with the top opening of the head positioned within the patient's nostril. Each conical head defines a passage (56) extending therethrough between the main cavity and the top opening, and is configured to further deliver the respiratory airflow from the main cavity to the patient's nasal passage. The feature is that each base portion (52) includes an inner edge (52A) and an opposing outer edge (52B), the inner edge (52A) being positioned near the center of the pad and merging with the hollow base (40), and the outer edge (52B) being arranged outside the pad and spaced upward from the outer surface of the hollow base by a distance (d).

2. The pad according to claim 1, wherein each base portion (52) is positioned at an angle (θ) relative to a central reference plane (P) that divides the pad in two, and wherein the angle is in the range of 45 degrees to 90 degrees.

3. The pad according to claim 1, wherein the hollow base (40) and the pair of nose pillows (48) are each part of a single unit component.

4. The pad according to claim 1, wherein the area where the inner edge (52A) of each base portion (52) merges with the hollow base (40) is at least one of the following: a thickness thinner than the wall of the adjacent hollow base, or formed of a material softer than the adjacent hollow base.

5. The pad according to claim 1, wherein the at least one aperture includes a first aperture disposed at a first end of the hollow base and a second aperture disposed at an opposite second end of the hollow base.

6. The pad according to claim 1, wherein each conical head (50) includes a plurality of ribs (58), each rib (58) extending partially from the inner surface of the conical head into the channel (56) defined in the head.

7. A patient interface device (8) for providing a respiratory therapy protocol to a patient, the patient interface device comprising: A frame (18) is configured to be coupled to the patient’s head via a headpiece (14); as well as The pad (16) according to any one of claims 1-6 is coupled to the frame.

8. A system (2) suitable for providing a respiratory therapy protocol to a patient, the system comprising: The pressure generating device (4) is configured to generate a breathing airflow; The delivery pipe (6) has a first end coupled to the pressure generating device and a corresponding second end; as well as Patient interface device (8), including: The frame (18) is configured to be coupled to the patient’s head via a headpiece; as well as The pad (16) according to any one of claims 1-6 is coupled to the frame.

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