Patent Application
20130133646
The present invention relates to positive airway pressure support systems, and, in particular, to patient interface devices for communicating a flow of to an airway of a user in which the patient interface device includes a helmet-style headgear adapted to support a mask on a user and to an associated method of using such a patient interface system.
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 positive airway pressure (PAP) therapy to treat certain medical disorders, the most notable of which is obstructive sleep apnea (OSA). Known PAP therapies include continuous positive airway pressure (CPAP), wherein a constant positive pressure is provided to the airway of the patient in order to splint open the patient's airway, and variable airway pressure, wherein the pressure provided to the airway of the patient is varied with the patient's respiratory cycle, e.g., bi-level and flex therapies, and/or varies based on the monitored condition of the user, e.g., auto-titration therapies. Such therapies are typically provided to the patient at night while the patient is sleeping.
Non-invasive ventilation and pressure support therapies, as just described, involve the placement of a 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 cannula having nasal prongs that are received within the patient's nares, a nasal/oral (full face) mask that covers the nose and mouth, or a total face mask that covers the patient's face. The 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.
Treating certain patients, such as young children and the elderly, that suffer from OSA or other respiratory disorders can be difficult as those patients are often unable and/or unwilling to fall asleep while wearing the patient interface device required for treatment. For example, young children may be uncooperative because they do not understand that, while the patient interface device may be slightly uncomfortable, it is necessary for proper treatment. As a result, young children suffering from OSA are traditionally treated using a tracheostomy, wherein an incision is made into the trachea, through the neck, and a tube is inserted so as to make an artificial opening for the passage of air into the airway of the patient. Tracheostomies, while effective, are difficult to maintain because they require frequent suctioning (24 hours a day) and because the tracheostomy site, if not properly cared for, can become infected, bleed or develop inflammatory issues. In addition, people with tracheostomies often have difficulty with speech and swallowing. Interfering with swallowing may impact nutrition and require additional surgery to provide a g-tube for patient feeding.
In addition, with current patient interface devices employing known headgear configurations, there is chance that the mask will be caused to move and a seal between the mask and the patient's face will be broken as a result of forces against the mask generated by patient movement while the patient is sleeping. These forces are often counteracted by applying stronger strapping forces with the headgear. However, in current patient interface devices, such increased strapping forces are borne largely be the head/face of the patient, which can result in discomfort and/or facial/head deformation/flattening.
In one embodiment, a positive airway pressure support system for treating a respiratory disorder is provided that includes a pressure generating device having a controller, wherein the pressure generating device is structured to produce an intermittent or continuous flow of breathing gas at a selected positive pressure or pressures under control of the controller, and a patient interface device operatively coupled to the pressure generating system and structured to deliver the flow of breathing gas to an airway of a patient. The patient interface device includes a helmet structured to be worn on the head of the patient, the helmet having a forehead portion structured to cover at least a portion of the forehead of the patient, a top portion structured to cover at least a portion of the top of the head of the patient, a rear portion structured to cover at least a portion of the rear of a head of the patient, and left and right side portions each structured to cover at least a portion of a respective side of the head of the patient, and a patient interface element selectively coupleable to at least one of the top portion, the left side portion and the right side portion of the helmet in manner which stabilizes the patient interface element relative to the helmet and resists forces applied to the patient interface element when the patient interface device is donned by the patient and the patient moves while in a supine position.
In another embodiment, a method of treating a respiratory disorder is provided that includes placing a helmet on the head of a patient while the patient is awake, the helmet having a forehead portion structured to cover at least a portion of the forehead of the patient, a top portion structured to cover at least a portion of the top of the head of the patient, a rear portion structured to cover at least a portion of the rear of a head of the patient, and left and right side portions each structured to cover at least a portion of a respective side of the head of the patient, waiting for the patient to fall asleep while wearing the helmet, while the patient is sleeping, attaching a patient interface element to the helmet, wherein the patient interface element is attached in a position wherein a cushion or other patient sealing member is in contact with the face of the patient, and after the patient interface element has been attached to the helmet, providing intermittent or continuous positive pressure to the airway of the patient via the patient interface element.
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.
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.
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).
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.
In the illustrated embodiment, pressure generating device 4 includes a pressure controller in the form of a valve 14 provided in delivery conduit 6. Valve 14 controls the pressure of the flow of breathing gas from flow generator 12 that is delivered to the patient. For present purposes, flow generator 12 and valve 14 are collectively referred to a pressure generating system because they act in concert to control the pressure and/or flow of gas delivered to the patient. However, it should be apparent that other techniques for controlling the pressure of the gas delivered to the patient, such as varying the blower speed of flow generator 12, either alone or in combination with a pressure control valve, are contemplated by the present invention. Thus, valve 14 is optional depending on the technique used to control the pressure of the flow of breathing gas delivered to the patient. If valve 14 is eliminated, the pressure generating system corresponds to flow generator 12 alone, and the pressure of gas in the patient circuit is controlled, for example, by controlling the motor speed of flow generator 12.
In the illustrated embodiment, pressure generating device 4 further includes a flow sensor 16 that measures the flow of the breathing gas within delivery conduit 6. In the particular embodiment shown in
Controller 18 may be, for example, a microprocessor, a microcontroller or some other suitable processing device, that includes or is operatively coupled to a memory (not shown) that provides a storage medium for data and software executable by controller 18 for controlling the operation of pressure generating device 4. Finally, input/output device 20 is provided for setting various parameters used by pressure generating device 4, such as the desired pressure settings, as well as for displaying and outputting information and data to a user, such as a clinician or caregiver.
In the exemplary embodiment, pressure support system 2 functions as either a CPAP system or a bi-level pressure support system, and, therefore, includes all of the capabilities necessary in such systems in order to provide an intermittent or continuous positive pressure to the patient or separate IPAP and EPAP levels to the patient. In the case of a bi-level pressure support system, U.S. Pat. No. 5,148,802 to Sanders et al., U.S. Pat. No. 5,313,937 to Zdrojkowski et al., U.S. Pat. No. 5,433,193 to Sanders et al., U.S. Pat. No. 5,632,269 to Zdrojkowski et al., U.S. Pat. No. 5,803,065 to Zdrojkowski et al., U.S. Pat. No. 6,029,664 to Zdrojkowski et al., and U.S. Pat. No. 6,920,875 to Hill et al., the contents of each of which are incorporated herein by reference, describe how to accomplish the necessary functions in order to provide separate IPAP and EPAP levels to the patient. These functions include techniques for detecting and estimating leak, and techniques for detecting the respiratory state of a patient, and managing, e.g., triggering and cycling, the bi-level delivery of breathing gas to the patient in the presence of leaks. Thus, a detailed discussion of these functions is omitted from the present application for the sake of simplicity and brevity
Returning to
Patient interface device 10 further includes a headgear component 28 that is securely attached to a helmet-type of element 30. In the illustrated embodiment, headgear component 28 includes first and second top straps 32A, 32B and first and second bottom straps 34A, 34B. Other configurations are also possible, including, without limitation, configurations including two straps, three straps or five or more straps, and configurations including one or more lever arms coupled to patient interface element 22, with to without one or more straps associated straps.
In an exemplary embodiment of the present invention, helmet 30 is made of a stiff material such as, without limitation, a plastic material, a stiff and/or lightweight foam material or a metal covered by a foam material, and may be similar to a head-shaping helmet that is currently used for correction of plagiocephaly (flattening of one side of the occiput) or a foam helmet used by seizure and/or balance disorder patients. As seen in
The present invention contemplates that the helmets can be made from common components that are connected in an adjustable manner, e.g., all forehead portions have the same size and shape and adjustably coupled to the other portions of the helmet. The present invention also contemplates that one or more of the components of the helmet can have different sizes or shapes. For example, the may be two or different “styles” of forehead portions. The user or caregiver selection the style (size and shape) forehead portion best suited to their forehead configuration and uses that selected forehead portion with the other portions of helmet. This selected forehead pad can be adjustably coupled to the other portions of the headgear. Finally, the present invention still further contemplates that one or more (or all) of the portions of the headgear can be customized to fit a particular user. For example, the single-piece type of helmet shown in
As described in greater detail elsewhere herein, the exemplary embodiment of patient interface device 10 employs a hook and loop fastening system, such as VELCRO®, to secure headgear component 28 and patient interface element 22 to helmet 30. In particular, terminal end 46 has hook connector patch 50 adhered thereto and terminal end 48 has hook connector patch 52 adhered thereto. As described in greater detail herein, hook connector patches 50, 52 are structured to be selectively connected to a loop connector portion that is provided on the underside of the first top strap 32A of headgear component 28.
As best seen in
In addition, shell 26 portion of patient interface element 22 includes slots 58A, 58B, each structured to receive and releasably hold a catch of a respective clip element 60A, 60B attached to bottoms straps 34A, 34B. In the exemplary embodiment, slots 58A, 58B and clip elements 60A, 60B are structured in the form of a ball and socket configuration, although it will be appreciated that other configurations for attaching the straps to the mask are also possible and contemplated by the present invention. Each clip element 60A, 60B also includes loop 62 for receiving a respective bottoms strap 34A, 34B of headgear component. In addition, bottoms straps 34A, 34B each include a respective terminal end 64A, 64B provided with a hook fastener component for connecting to a loop fastener portion (not shown) provided on back portion 66 of headgear component 28. This hook and loop fastening system allows the length of bottoms straps 34A, 34B to be adjusted, and thus the size of headgear component 28 to be partially adjusted.
In order to attach patient interface device 10 to helmet 30, the size of headgear component 28 is first adjusted so that it fits snugly around the exterior of helmet 30 by adjusting top straps 32A, 32b and bottom straps 34A, 34B as just described. When so adjusted, patient interface device 10 will able to be fit over and around helmet 30 as shown in
Although hook connector patches 50, 52 are shown in the illustrated embodiment as being provided only on one side of helmet 30, it will be appreciated that similar patches may be provide don the other side of helmet 30 for attaching to a loop connector portion that is provided on the underside of the second top strap 32b in order to provide increased attachment force. In addition, in the illustrated embodiment, optional strip 68 having a loop connector portion provided on the underside thereof may be placed over top strap 32A as shown in
As described elsewhere herein, some individuals, such as children, are unable and/or unwilling to fall asleep while wearing a patient interface device for treatment of a sleeping disorder such as sleep apnea (for example, children may be uncooperative because they do not understand that, while the patient interface device may be slightly uncomfortable, it is necessary for proper treatment). According to one exemplary embodiment, pressure support system 2 described herein may be used in a method that facilitates and encourages use by such individuals during sleep. In particular, according to this method, helmet 30 is placed on the head of the individual in a condition wherein patient interface element 22 is positioned away from the face of the individual and elbow connector is detached from conduit 6.
For example, and without limitation, helmet 30 may be placed on the head of the individual in a condition wherein bottom straps 34A, 34B are detached from shell 26 of patient interface element 22 and allowed to hang to the side and wherein patient interface element 22 is positioned on/adjacent to the top rear portion of helmet 30 out of the way of the individual's face (patient interface element 22 will still move as the wearer moves). This condition is illustrated in
The individual is then allowed to fall asleep naturally with patient interface element 22 positioned away from their face. Once the individual falls asleep, a caregiver, such as a parent, nurse or personal care attendant (PCA), may then reposition patient interface element 22 such that patient interface element 22 is properly positioned to provide therapy (e.g., covering the individual's nose in the case of a nasal mask) and connect elbow connector 8 to conduit 6. If the configuration illustrated in
Furthermore, patient interface device 10 is additionally beneficial due to the fact that, when worn, helmet 30 is fixed in position relative to the wearer's head, and patient interface element 22 is fixed in position relative to helmet 30 (in the embodiment of
In addition, strapping forces and pressures applied by top straps 32A, 32B and bottom straps 34A, 34B are largely borne by helmet 30 and not the head (including the face) of the wearer since contact by top straps 32A, 32B and bottom straps 34A, 34B with the head will be minimal or nonexistent. This helps to reduce the possibility of facial/head deformation/flattening and/or facial obtrusions (red marks, welts, blisters) that may otherwise result from such forces (this is particularly important in the case of young children that may not have fully developed bone structures). The strapping forces may be adjusted by adjusting top straps 32A, 32B and bottom straps 34A, 34B. The total strapping force is a combination of the lifting force due to the intermittent or continuous positive pressure and the force required to create and maintain a seal. With normal, known fabric headgear, the majority of the force is applied to the back of the wearer's head. The large contact area of helmet 30 (and the other helmet embodiments described herein) increases the distribution of the forces which reduces the likelihood of any skull/face deformation and reduces the strapping force needed for stability. For example, on a large full-face mask at a positive pressure of 20 cmH20, each strap would only pull with approximately 1 lb force if the present invention is employed.
Referring to
In addition, rear end 126A, 126B of top straps 118A, 118B and rear end rear end 128A, 128B of bottom straps 120A, 120B are each provided with a loop fastener portion on the underside thereof. Patient interface element 22 may thus be attached to helmet 74 by attaching the loop fastener portion of rear end 126A of top strap 118A to hook connector patch 100, the loop fastener portion of rear end 126B of top strap 118B to hook connector patch 110, the loop fastener portion of rear end 128A of bottom strap 120A to hook connector patch 106, and the loop fastener portion of rear end 128B of bottom strap 120B to hook connector patch 116 at appropriate locations to provide the desired fit. Fit may also be adjusted by adjusting the length of top straps 118A, 118B and bottom straps 120A, 120B.
Like pressure support system 2, pressure support system 70 may be used in a method that facilitates and encourages use by such individuals during sleep. In particular, helmet 74 is placed on the head of the individual in a condition wherein either top strap 118A and bottom strap 120A or top strap 118B and bottom strap 120B are detached from shell 26 of patient interface element 22, which allows patient interface element 22 to hang to one side of helmet 74 and away from the individual's face. The individual is then allowed to fall asleep naturally with patient interface element 22 positioned away from their face. Once the individual falls asleep, a caregiver, such as a parent, then repositions patient interface element 22 such that patient interface element 22 is properly positioned to provide therapy by attaching the detached straps as described elsewhere herein. The caregiver also connects elbow connector 8 to conduit 6 and then activates pressure generating device 4 to begin the provision of therapy. This method allows the individual to fall asleep without the discomfort caused by patient interface element 22 contacting their face and without the noise generated by pressure generating device 4, with therapy beginning only after the individual has fallen asleep. In addition, patient interface device 72 as just described provides the same fixation and immobilization benefits that were discussed elsewhere herein in connection with patient interface device 10.
Alternative connection mechanisms for coupling a plurality of straps, such as top straps 146 and bottoms straps 148, to a helmet, such as helmet 134, are also contemplated, including, without limitation, snaps or buckles.
It can be appreciated that the present invention provides a solution to the need for an effective, non-invasive system and method for treating patients, such as young children, adults and the elderly, suffering from OSA or a similar respiratory disorder that are unable and/or unwilling to fall asleep while wearing the patient interface device that is required for treatment. Moreover, the present invention addresses the need for a patient interface device that provides effective mask stability (against forces that may be generated by patient movement during sleep) without applying a significant strapping force to the head/face of the patient.
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.
This patent application claims the priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61/309,607 filed on Mar. 2, 2010, the contents of which are herein incorporated by reference.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IB11/50779 | 2/24/2011 | WO | 00 | 2/12/2013 |
| Number | Date | Country | |
|---|---|---|---|
| 61309607 | Mar 2010 | US |
