Patent Application
20220347403
This invention relates to medical devices and, more particularly, to filtration devices (FD) which can be used in conjunction with devices such as a nebulizer or a respiratory face mask, to capture aerosols and the like which may be expelled by a user. Said filtration devices may be referred to as “exhalation” filtration devices.
In the 2020 Coronavirus pandemic, treatment options for patients with shortness of breath were limited due to the fear that first line and hospital personnel would be exposed to aerosolized viral particles expelled by patients into the environment. Prior to the pandemic, aerosolized medication inhaled by healthcare providers has also been an issue which this invention also addresses.
A nebulizer is a piece of medical equipment that a person with asthma or another respiratory condition can use to administer medication directly and quickly to the lungs. A nebulizer turns liquid medicine into a very fine mist that a person can inhale through a face mask or mouthpiece.
Generally, there are three main types of nebulizers:
Nebulizers are especially good for infants' or small children's asthma medications. They're are also helpful when you have trouble using an asthma inhaler or need a large dose of an inhaled medication.
Nebulizers are quite commonplace in hospitals and clinics these days and you'll even find quite a number of households that have one too.
Quite simply, a Nebulizer is not an oxygen delivery device, nor is it a humidifier. A Nebulizer is a drug delivery device that can dispense medication directly into the lungs in the form of an inhalable mist.
Nebulizers are used to treat various lung diseases such as: asthma, cystic fibrosis, chronic obstructive pulmonary disease (COPD), and other severe forms of lung infections and diseases.
The Nebulizer machine uses a mixture of processes involving oxygen, compressed air, and even ultrasonic power to atomize and vaporize liquid medication into small aerosol droplets, or a mist, that can be inhaled directly into the lungs.
There are three main types of electrical Nebulizers which can currently be found.
See https://omnisurge.co.za/what-are-nebulizers-and-how-do-they-work/In
In some examples of the invention described below, a Jet Nebulizer may be shown as an exemplary nebulizer, working in conjunction with the Filtration Device disclosed herein. The invention may be suitable for use with other types of nebulizers. An example of a nebulizer is the Hudson RCI 1724 Up-Draft Nebulizer.
The nebulizer has the following major components:
Generally, compressed air may be delivered to the reservoir, via the hose (shown at the bottom of the reservoir), and aerosolized medication is provided to the coupling component. A valve or valves (not shown) may be incorporated into the T-shaped coupling component to (i) direct the aerosolized medication through the mouthpiece, when the patient inhales, and to (ii) direct the patient's exhaled air out the exhaust pipe to the environment.
Page 1 of the APPENDIX provided herewith shows a “Prior Art” example of a handheld nebulizer with mouthpiece, along with a bacterial/viral filter, and illustrates that a patient may inhale clean aerosolized air from the nebulizer, and may exhale contaminated air to the environment, preferably through the filter.
The B/V filter may be 4444/01BAUA Bacterial/Viral filter for nebulizer therapy machine “Bacterial/Viral filter for nebulizer therapy machine clinic clean pouch packed” by GVS, or the like. see http://www.gvs.com/product-family/160/963/4444
Nebulized therapy is often called a breathing treatment. You can use nebulizers with a variety of medications, both for controlling asthma symptoms and for relief right away. These include:
Providing filtration of air exhaled by the patient during these treatments is very important, as evidenced by the following: “RESPIRATORY CARE OF THE NONINTUBATED PATIENT” See https://www.uptodate.com/contents/coronavirus-disease-2019-covid-19-critical-care-issues
A nebulizer, such as described above, is considered to be a “non-rebreathing” device, since air, once exhaled, is not re-inhaled by the patient.
Some Patent (and Other) Publications
The Following Patents and Publications May be Relevant to the Invention(s) Disclosed Herein.
Circulaire II High-Efficiency Aerosol Drug Delivery System, Westmed, 2020, 6pp
Reducing Aerosol-Related Risk of Transmission in the Era of COVID-19: An Interim Guidance Endorsed by the International Society of Aerosols in Medicine, Fink et al., Journal of Aerosol Medicine and Pulmonary Drug Delivery, Vol 30, No. 6, 2020, 6pp
Filter Considerations in the COVID-19 Era, Mike Pedro, Vyaire Medical, 15pp
The present invention may be particularly applicable to use with a handheld nebulizer with mouthpiece.
The present invention may be particularly applicable to use with a respiratory nebulizer aerosol therapy mask.
It is a general object of the invention to provide filtration of air exhaled by a patient and, more particularly, to a patient using a handheld nebulizer, or a patient wearing a respiratory nebulizer aerosol therapy mask. Other (different, additional) applications (uses) may be within the scope of the invention.
An embodiment of the invention may comprise a filtration device (FD) adapted to be used with a device such as a handheld nebulizer which will allow a patient to receive either oxygen at high flow or nebulizers at high flow, while filtering the environment from viral particles which may be exhaled by the patient.
According to an embodiment of the invention, a filtration device (FD) may comprise:
A bottom portion of the bag (B) may comprise a collection reservoir (R) for collecting aerosols and particles exhaled by a patient.
The inlet port and outlet port may be disposed on a same side of the bag. The inlet port may be slightly smaller in diameter than the exhalation port.
The inlet port and outlet port may be disposed on opposite sides of the bag.
According to the invention, generally, a Non-Rebreather Exhalation Filtration Device (FD) with a front plastic sheet (PS), an aerosol separator (AS) and optionally a collection reservoir (R) may be fitted (i) (
According to an embodiment of the invention, an exhalation filtration device (FD) may comprise: a plastic sheet (PS) having a periphery and an inlet port (IP); a filter element (FE) disposed behind the plastic sheet; and an aerosol separator (AS) disposed between the plastic sheet and the filter element. The aerosol separator may cover the inlet port.
The filtration device may be adapted for mounting to a respiratory mask (M) having a port (P), and may further comprise: an adhesive layer (AL) disposed on a front surface of the plastic sheet (PS) for mounting the filtration device to the mask with the inlet port of the filtration device aligned with the port of the mask. The adhesive may be suitable for allowing a given filtration device to be removed from the mask, and installing another (“fresh”) one. The adhesive layer may form a seal between the filtration device and the mask. The adhesive layer may be disposed directly on the plastic sheet, around the inlet port. The adhesive layer may comprise a pressure-sensitive adhesive having a thickness of approximately 2 mil (0.002 in; 0.05 mm). A portion of the mask having the port and to which the filtration device is mounted may be substantially flat, and may be at least somewhat rigid. Reference may be made to
The filtration device may further comprise: a flexible substrate (FS) disposed between the adhesive layer and the front surface of the plastic sheet and having an opening aligned with the inlet port of the filtration device. The flexible substrate may be secured to the front surface of the plastic sheet by welding or adhesively sticking the flexible substrate to the plastic sheet. The flexible substrate may be donut-shaped. A portion of the mask having the port and to which the filtration device is mounted may be substantially non-flat, and may be at least somewhat flexible.
The flexible substrate helps maintain the filtration device mounted to said non-flat and/or flexible surface of the mask. Reference may be made to
The filter element has a perimeter, and the periphery of the plastic sheet may be attached, such as by welding (heat sealing), to the perimeter of the filter element.
The aerosol separator may comprise a sponge element (SE).
A deflector (D) may be disposed between the inlet port (IP) and the aerosol separator (AS);
A reservoir (R) may be disposed at an interior portion of the filtration device.
Stiffening components (SC) may be added to the filtration device, such as on the plastic sheet, to control flexure during inhalation and exhalation.
The plastic sheet may comprise a thermoplastic material such as polyethylene, polypropylene, etc., which can easily and reliably be joined (welded together) using heat. The plastic sheet may have a diameter of approximately 3 or 4 inches (7.5 or 10 cm), and may have thickness of approximately 6 mil (0.006 inch; 0.15 mm).
The filter element may comprise a pad type filter, may have a diameter of approximately 3 or 4 inches (7.5 or 10 cm), and may have thickness of approximately 43 mil (0.043 inch; 1.1 mm).
The aerosol separator may comprise a sponge element (SE).
The filtration device may further comprise: a second plastic sheet (PS2) disposed on a back side of the filtration device, behind the filter element.
The filtration device disclosed herein may provide some of the following advantages over the prior art techniques:
Other objects, features and advantages of the invention(s) disclosed herein may become apparent in light of the following illustrations and descriptions thereof.
Reference will be made in detail to embodiments of the disclosure, non-limiting examples of which may be illustrated in the accompanying drawing figures (FIGS.). The figures may generally be in the form of diagrams. Some elements in the figures may be stylized, simplified or exaggerated, others may be omitted, for illustrative clarity.
Although the invention is generally described in the context of various exemplary embodiments, it should be understood that it is not intended to limit the invention to these particular embodiments, and individual features of various embodiments may be combined with one another. Any text (legends, notes, reference numerals and the like) appearing on the drawings are incorporated by reference herein.
Some additional figures are presented in the APPENDIX, and are incorporated by reference herein.
Drawing Key and Abbreviations
The following abbreviations may be used (in the manner of reference numerals) in the text and/or drawings to identify the following items, such as the mask (M) and, more particularly, parts or components of the overall filtration device (FD), in its various embodiments.
The filtration device (FD) may sometimes be referred to simply as “filter”, but should not be confused the filter element (F, FE) which also may sometimes be referred to simply as “filter”.
Various embodiments (or examples) may be described to illustrate teachings of the invention(s), and should be construed as illustrative rather than limiting. It should be understood that it is not intended to limit the invention(s) to these particular embodiments. It should be understood that some individual features of various embodiments may be combined in different ways than shown, with one another. Reference herein to “one embodiment”, “an embodiment”, or similar formulations, may mean that a particular feature, structure, operation, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Some embodiments may not be explicitly designated as such (“an embodiment”).
The filtration device disclosed herein is intended to filter the exhalation cycle (exhalation phase of the overall breathing cycle of inhale/exhale) in the context of:
In an embodiment, the filtration device may be adapted specifically and exclusively to providing nebulized or aerosolized medications to a patient, although it may also be suitable for providing oxygen to a patient.
Nebulizer and aerosol treatments typically deliver medication to the patient. Oxygen treatments may only have gas delivery without the medication. Whatever the application, it is important to protect first responders, doctors and nurses from the patient exhalation, and also to protect the patient from any contaminants in the ambient air.
In the
In the
A filtration device (FD) conforming to the
Dimensions, Materials
The following dimensions and materials may be suitable for the Filtration Device.
For the plastic components (plastic sheets, etc.), suitable materials would be thermoplastics—Polyethylene, Polypropylene, etc., which can easily and reliably be joined (welded together) using heat.
Dimension are based on the filter size and inlet port size for creating a tight seal around the nebulizer tube and the ability for minimal bag movement during exhalation so air can flow around deflector to the filter. Approximately 4 inch (10 cm) diameter for a circular filter.
The Filtration Device (FD) disclosed herein is intended to be inexpensive, easy to use, and disposable (single use).
Appendices
Provisional application 63/182,937 was filed with two appendices:
Included with this filing is a document (“APPENDIX”) entitled “Non-Rebreather Exhalation Filtration Device with Aerosol Separator and Collection Reservoir”. The APPENDIX document is incorporated by reference herein and forms part of the Specification (description) hereof. The APPENDIX document comprises 23 pages. Pages 1-14 of the APPENDIX document reprise Appendix 2 which, in turn, reprised Appendix 1. Pages 15-23 of the APPENDIX document are “new” in that they disclose an “update” to the design(s) disclosed in Appendices 1 and 2, with some changes, additions and/or clarifications, and present some additional or alternative embodiments of the invention.
The APPENDIX document is discussed below. The APPENDIX document contains text. Some changes or “editorial comments” may be presented herein. The APPENDIX document contains illustrations, which may be considered to be “Drawings” (or Figures of the Drawing), some of which correspond to drawing figures presented herein.
Discussion of the APPENDIX Document
Page 1
This page shows (i) a handheld nebulizer, and (ii) a bacterial/viral filter, of the prior art.
Some problems with this prior art may be that . . .
Page 2
This page illustrates an Exhalation Filtration Device (FD) with Aerosol Separator and Collection Reservoir.
The filtration device (FD) may comprise three (3) components (elements):
The device depicted here is also shown at
The filter element (FE) may be a Blended Synthetic Fiber and Laminate Scrim of Polypropylene, and may be round, measuring 3″ in (7.5 cm) in diameter, and 43 mil (0.043 inch; 1.1 mm) in thickness.
The plastic sheet (PS) may be a sheet of a plastic material such as polyethylene, and may be round, measuring approximately 3 inches (7.5 cm) in diameter, and 6 mil (0.006 inch; 0.15 mm) in thickness. The overall diameter of the filtration device (FD) may also be approximately 3 inches (7.5 cm). All dimensions set forth herein are approximate and exemplary.
The filter (FE) may be slightly larger (in diameter) than the plastic sheet (PS), or vice-versa.
The perimeter (periphery) of the plastic sheet may be securely attached to the perimeter of the filter, such as by ultrasonic welding, impulse heating, or with an appropriate adhesive.
The sponge element (SE) may be a flat sponge, approximately 0.25″ thick. It may be round, smaller in diameter than the filter or the plastic sheet, and may be disposed between the plastic sheet and the filter prior to welding the sheet to the filter. The purpose of the sponge is to
An inlet port (IP) is shown. The inlet port is essentially an opening in the plastic sheet. The opening may be slightly smaller than the nebulizer exhaust tube.
The diameter of the nebulizer exhaust tube is typically approximately 0.875 inch (2.2 cm) OD.
All dimensions set forth herein are approximate, and exemplary. By way of non-limiting example, a round filtration device may be 3 inches (7.5 cm) in diameter, +/−1 inch (2.5 cm).
Notably, the diameter of the filter is many (such as 2-6) times greater than the diameter of the nebulizer exhaust tube (NET; aka exhalation tube), or the exhalation end of a conventional B/V filter such as shown on Page 1.
The plastic sheet (PS) may be welded directly to the filter (F) with the sponge in between.
This embodiment of the filtration device (FD) works well when the filter size is larger than the side of the Handheld Nebulizer exhalation tube (NET)—in other words, a relatively large filter (FE) and a relatively small inlet port (IP). This allows the plastic sheet (PS) to wrap around the sponge (SE) without deforming the filter (FE).
Refer to Page 4 for a Non-Rebreather configuration (with additional deflector (D)).
Page 3 (One Component Added for Ease of Manufacture)
The filtration device (FD) described above (APPENDIX; Page 2) has 3 components—filter element (F, FE), sponge (S), and (front) plastic sheet (PS). Page 3 shows an embodiment with an extra (fourth) component added. The extra component is an additional plastic sheet (PS2) on the back (rear, opposite) side of the filtration device (FD), behind the filter element (FE).
In the 3-component embodiment, the plastic sheet with the inlet port (IP) is attached to the filter element (FE). In the 4-component embodiment, there is another plastic sheet (PS2) that supports an outlet port (OP). This plastic sheet (PS2) may be attached to the filter element (FE), and both plastic sheets (PS, and PS2) may be attached (joined, such as by welding) at their peripheries.
The four illustrations across the top of Page 3 show, from left-to-right . . .
The Back Plastic Sheet (PS2) May be Either in Front of or Behind the Filter.
The sponge element (SE) serves 3 functions/purposes: (i) as an aerosol separator, (ii) as a spacer to keep the nebulizer exhalation tube (NET) spaced away/apart from the filter element (FE) to eliminate the opportunity for obstruction/restriction, and (iii) to support the front plastic sheet (PS) during insertion of the nebulizer exhalation tube (NET) into the inlet port (IP). Refer to Page 12 for a more detailed representation of the nebulizer exhalation tube (NET) being inserted into the inlet port (IP) of the front plastic sheet (PS).
From the first two illustrations, it is apparent that there are two plastic sheets (PS, PS-1, PS-2). These two sheets are both in the form of discs, with holes at their center, and the two sheets may be welded together around their perimeter (circumference) to form a bag, with the aerosol separator or sponge disposed between the two plastic sheets, in the bag.
Whereas the Page 2 embodiment had only a single plastic sheet with an inlet port, this (Page 3) embodiment has two sheets of plastic, joined around their peripheral edges, to form a bag.
The Bag (B) Comprises:
The Filtration Device (FD) may further comprise:
The Aerosol Separator (AS) is made of open cell sponge low flow resistance material such as used in air conditioning systems for air filtration:
The three illustrations across the bottom of the page show, from left-to-right . . .
Page 4
This page illustrates a non-rebreather embodiment of an exhalation filtration device (FD). This embodiment is similar to the embodiment at Page 3, with the addition of a deflector element (D), which functions as a sort of check valve to allow air to be exhaled through the filtration device (FD) without allowing air to be inhaled through the filtration device (FD), hence the term “non-rebreather”.
This embodiment of the filtration device (FD) has a separate, additional non-rebreather deflector element (D, or NRD) which may act as a sort of check valve, making the filtration device (FD) a “non-rebreather” apparatus. The non-rebreather deflector (D) element facilitates the non-rebreather (i.e., one way, patient exhale only) operation of the filtration device (FD). The non-rebreather deflector (D) may deflect aerosols and particles by causing aerosols and particles impinging upon the rebreather deflector (D) during patient exhalation to be prevented from impinging on the aerosol separator (AS) or sponge element (SE) and onto the filter (F, causing the aerosols and particles to drip down (by gravity) into a reservoir (R) bottom portion of the filtration device (FD).
The previous (Page 3) embodiment has two sheets of plastic (PS, PS2), joined around their peripheral edges, to form a bag (B), and an aerosol separator (AS) disposed in the bag.
In this embodiment, a deflector (D) is disposed (located) between the inlet port (IP) in the front plastic sheet (PS) and the aerosol separator (AS) or sponge element (SP) and is also enclosed within the filtration device (FD).
When the patient inhales through the nebulizer (page 1), with the filtration device (FD) in place on the nebulizer exhaust tube (NET), the deflector (RD) is drawn towards the patient, blocking the inlet port (IP) and/or creating a seal with the nebulizer exhaust tube (NET) inserted through the inlet port (IP) so that the inlet port (IP) is blocked/sealed during inhalation.
When the patient exhales through the nebulizer, with the filtration device (FD) in place on the nebulizer exhaust tube (NET), the deflector (D) is pushed away from the patient to permit air flow through the inlet port (IP), around the deflector (D), and through the aerosol separator (AS) or sponge element (SP).
The two illustrations on the bottom of Page 4 show the position of the non-rebreather deflector (D, NRD), and subsequent blocking (during inhalation) or preventing (during exhalation) of air flow through the filtration device (FD).
In
Some differences between the Page 3 (previous) and Page 4 (this) embodiments may be noted:
The bag, indeed the entire Filtration Device (FD) is intended to be inexpensive to manufacture, and readily disposable (e.g., “single use”).
The front and rear plastic sheets (PS, and PS2, respectively) may be joined (such as heat sealed, or welded) at their peripheral edges to form a bag (B), having an inlet port (IP) and an outlet port (OP), otherwise air-tight, and containing the filter (F) and the non-rebreather deflector (NRD).
A bottom portion of the bag is shown, serving the purpose of a reservoir (R) for collecting aerosols and/or particles separated by the aerosol separator (AS) or sponge (SP).
The reservoir (R) may be seen at Pages 5 and 6.
Page 5
This page shows an embodiment of an Exhalation Filtration Device (FD) with Aerosol Collection Reservoir (R). The illustration on the left shows the nebulizer, with a filtration device fitted to the exhaust tube (NET) of the nebulizer.
The illustration on the left of Page 5 shows the filtration device (FD) mounted on a handheld nebulizer. The reservoir (R) is at the bottom of the bag (circled), and may be any interior portion (volume) of the bag (B) that can collect droplets. It need not be a separate component.
An exemplary (illustrative) filtration device (FD) of the present invention may comprise:
Some additional components, or variations/modifications of the components (bag, filter) mentioned above may also be incorporated into the filtration device, and may be shown in subsequent pages.
For example, stiffening components (SC) may be added to portions of the bag to control its flexure during inhalation and exhalation, and to improve mounting the filtration device (FD) securely to the nebulizer exhaust tube (NET).
The bag is intended to be flexible, so that in use, when the patient inhales, the bag may collapse. The nebulizer may (or may not) have enough flow to permit this. Some nebulizers are not able to supply sufficient air flow and therefore the non-rebreather option (e.g., Page 3 embodiment) may not be usable. Conversely, the bag may expand when the patient exhales. When the bag collapses, the filter, or another component, may be drawn against the exhaust tube of the nebulizer, shutting it off.
The bag (B) may act like a bellows, and should be sufficiently large so that although the filter element (F, FE) is disposed in front of the inlet port (IP), the sponge element (S, AS) disposed on the nebulizer side of the filtration device (FD) prevents the filter (F) from acting like the aforementioned deflector (D). If the filter is ‘across’ the inlet port, then it may not move. It may abut the nebulizer exhalation tube (NET) thereby restricting the air flow to that portion of the filter element (F, FE). The addition (inclusion) of the sponge element (S, AS) between the filter element (F, FE) and the inlet port (IP) resolves that issue, allowing the filter element (F, FE) to move away from inlet port (IP) during exhalation.
A smaller device may be achieved by using a smaller, but thinner bag material, thereby increasing flexibility; however, it may make manufacturing more challenging.
In some embodiments, a flexible flap of material (not shown) may be disposed over the inlet port (IP), on the interior of the filtration device (FD), in a “normally closed” position, so that the flap (or filter element F), if disposed over the inlet port, may function as a one-way (“check”) valve that opens when the patient exhales through the nebulizer and into the filtration device (FD), and closes when the patient inhales.
It may be noted that some nebulizers have built in check valves, some do not.
Page 6
This page shows an embodiment of a non-rebreather exhalation filtration device (FD) with Aerosol Separator (AS) and collection reservoir (R).
It bears mention that the non-rebreather (e.g., “check valve”) feature is optional with various embodiments disclosed herein.
The left-hand illustration shows an additional deflector element (D).
The bag may be described as having two generally rectangular walls (the walls could be round), and may be manufactured from a single sheet of flexible plastic material having a lower (as viewed) generally rectangular portion (area) for one wall of the bag, and an upper (as viewed) generally rectangular portion (area) for the other wall of the bag.
A stiffener element (ST) (not shown in this embodiment) may be mounted to the lower portion of the bag, over an inlet port (IP).
The filter (F) may be mounted to the upper portion of the bag, over an outlet port.
A deflector element or component (D) may be incorporated into the bag of the filtration device (FD).
The deflector component (D) resides inside the bag, between the inlet port and the filter, so direct exhalation breath does not reach the filter but must travel around the deflector component (D) to exit through the filter.
The deflector component (D) should be rigid, is shown having a cross or cruciform shape, and may be disposed inside the bag between the inlet port and filter/outlet port as to not restrict the bag inflation/bellow movement when the patient exhales. To this end, the deflector component may be dimensioned so that it freely “floats” (is free to move towards or away from the inlet port), with a central portion covering/uncovering the inlet port, and it arms (extending radially from the central portion towards (but not connected to) respective side edges of the bag.
When the patient exhales, aerosols or particles suspended in the patient's breath will contacts the deflector, and may separate (from the gas in the patient's breath), and may collect in the bag. Refer to the diagram marked “Exhalation”.
When the patient inhales, the bag collapses under pressure and pushes the deflector onto the Handheld Nebulizer exhalation (exhaust) tube, blocking air from entry thereby forming a non-rebreather valve. Refer to the diagram marked “Inhalation”.
In this regard, the deflector component may function essentially as a check valve, allowing free flow in only one direction—into the bag from the inlet port, and out of the bag through the outlet port (through the filter).
Page 7
This page shows a Non-Rebreather Exhalation Filtration Device with Aerosol Separator and Collection Reservoir. See also Pages 8,9.
This page shows a front view, a rear view and a side view of the filtration device (FD).
Also shown are
Page 8
This page shows Non-Rebreather Exhalation Filtration Device with Aerosol Separator and Collection Reservoir
This page shows a front view and a rear view of an embodiment of the filtration device (FD) with the outlet port disposed above the inlet port, on the same or on opposite sides of the bag.
Also shown are the following features, which may be associated with or incorporated into different embodiments of the filtration device (FD). These features may include (but are not limited to) the following.
It is worth noting that the bottom of the bag (B) may be extended to form a collection reservoir (R), as mentioned above, for collecting aerosols and/or particles exhaled by the patient.
Page 9
This page shows Non-Rebreather Exhalation Filtration Device with Aerosol Separator and Collection Reservoir
This page shows some alternative constructions, which may be considered to be “enhancements”.
Notice that the filter element (F, FE) and outlet port (OP) are disposed in an upper portion of the filtration device (FD), above the lower portion of the filtration device (FD) which has the inlet port (IP).
The aerosol separator (AS) is disposed in the lower portion of the filtration device (FD), at the inlet port (IP), and may comprise a screen mesh (SM).
Also, a stiffener component (SC) is disposed around the inlet port (IP) for increased rigidity while mounting the inlet port (IP) onto the handheld nebulizer exhalation tube (NET). The stiffener component (SC) may be mounted internally or externally to the bag (B)
Page 10
This page shows Non-Rebreather Exhalation Filtration Device with Aerosol Separator and Collection Reservoir
The upper illustration shows that during inhalation, the filtration device (FD) collapses to prevent flow from the environment.
The lower illustration shows that during exhalation, the filtration device (FD) opens to direct air from the handheld nebulizer exhalation tube (NET) through the filter element (F). Notice that the filter element and outlet port (OP) are disposed above the inlet port (IP).
Page 11
This page illustrates an embodiment of the filtration device (FD) adapted for in-line connection (attachment) to an evacuation hose or to a ventilation device.
In this embodiment, the filtration device (FD) may comprise:
Additionally,
In some of the embodiments disclosed herein, an extra component, such as a tab, may be incorporated into the first plastic sheet to facilitate pulling the inlet port (IP) over the nebulizer exhaust tube (NET). Or, a stiffener, described below.
Page 12
This page shows three features of the sponge component(s) (AS, SE), and is applicable to embodiments with sponge component(s).
These features are described in the context of a nebulizer exhaust tube (NET) inserted into the inlet port (IP) of the filtration device (FD), such as was shown at Page 3.
Feature 1
This is shown in the two illustrations on the left
In the left one of these two illustrations (Restricted Flow Undesirable), it is illustrated that if the nebulizer exhaust tube (NET) is inserted into the inlet port (IP), without a sponge element (AS), the end of the nebulizer exhaust tube (NET) may abut the filter (F). This would be undesirable, as it would restrict flow through the filtration device (FD).
In the right one of these two illustrations (No Flow Restriction), it is shown that the sponge (AS) functions as a spacer (stand-off) between the end of the nebulizer exhaust tube (NET) and the filter element (F), avoiding contact between the two components which would cause a flow restriction, thus permitting unrestricted flow through the filtration device (FD).
Feature 2
This figure illustrates that the sponge supports the plastic sheet (inlet side) during insertion of the nebulizer exhaust tube (NET) into the inlet port of the filtration device (FD). This allows the inlet port (IP) to expand and “snap” over the nebulizer exhaust tube, and may eliminate a need for an extra component to pull the inlet port over the nebulizer exhaust tube.
Feature 3
This figure illustrates that the sponge acts as an aerosol extractor (or aerosol separator AS) which will keep the filter element (F, FE) dry, longer (than without the sponge “filtering” out aerosols). Aerosols may be extracted by the sponge prior to the air stream that they are in contacting the filter element.
As the aerosol travels through the many open cells of the sponge, the aerosol droplets bump into and merge with each other to form larger aerosol droplets that collect away from the filter, such as in a reservoir (R) portion of the bag (B). Some drops are illustrated at the bottom of the bag.
Page 13
This page shows an embodiment of a filtration device (FD) with only two components. Generally, the device is a two-dimensional assembly that conforms to allow an axial connection and forms a seal with the nebulizer exhaust tube (NET).
The figure(s) on the left are a side (cross-sectional) view and a front (inlet port side) plan view of the filtration device (FD), which may comprise:
The figure(s) on the right are a side (cross-sectional) view and a front (inlet port side) plan view of the device, with the inlet port stretched over a tube which may be the nebulizer exhaust tube (NET) or an inlet tube (IT; refer to Page 11).
The inlet port (IP) may be sized to be smaller (in diameter) than the tube (NET or IT) so that a seal between the filtration device (FD) and the tube is formed at the interface of the inlet port (IP) in the plastic sheet and the tube. A seal may be formed at the interface, since the plastic inlet port may be undersized so that it stretches over the tube.
Both sets of figures show that the plastic sheet (PS) may be welded to the filter element (F) around their common peripheries (circumferences). This forms a type of bag (B), with one side being a plastic sheet (with an inlet port), the other side being the filter element which is permeable.
In a “relaxed” state (no airflow through the device), the substantially flat plastic sheet may be substantially abutting the substantially flat filter.
When air is passing into the device through the inlet port (IP) in the plastic sheet (and ultimately exiting through the filter), the “bag” tends to inflate, resulting in the plastic sheet and filter moving away from one another. This allows air entering the filtration device (FD), through the inlet port (IP), to self-distribute over the entire surface area of the filter element (F). No sponge or aerosol separator (AS) is shown in these figures, and may not be present in this embodiment.
Reference may be made to Feature 1 (Page 12) which discloses how the sponge element (aerosol separator (AS) prevents restricted flow, helps separate and protect the filter from aerosols, and may distribute incoming air over a greater area of the filter element (F, FE). The filter element (F, FE) has a much larger diameter than the inlet port (IP) or tube (NET, IT).
Page 14
This page illustrates Means of Facilitating Easy Mounting of Inlet Port Over Tube, Transforming the Two Dimensional Assembly (e.g., Page 13) into an Axial Connection.
The figure(s) on the left are a side (cross-sectional) view and a front (inlet port side) plan view of the device, and show that a filtration device (FD) may comprise:
The stiffener (or stiffer) component (SC) may be an additional piece of plastic located around the inlet port (IP). The stiffener component may be in the form of a ring, having an inside diameter approximately equal to the diameter of the inlet port (IP), and an outside diameter greater than the inside diameter and less than the outside diameter of the plastic sheet (PS) or the filter element (F).
Again, reference may be made to Feature 1 (Page 12) which describes how incorporating a sponge element (aerosol separator (AS)) may be useful.
The figure(s) on the right are a side (cross-sectional) view and a front (inlet port side) plan view of the device, and show that a filtration device (FD) may comprise:
The sponge supports the plastic sheet (PS) during tube insertion so that the inlet port (IP) can expand and fit snugly over the tube.
It should be understood that various features or elements of the various embodiments disclosed herein can be “mixed and matched” to produce a wide variety of filter devices suitable for various applications. All of the embodiments are intended to be low cost, effective, and disposable (single use). Pages 15-23 disclose some additional embodiments and/or variations of the filtration device (FD).
Page 15
This page (“Means of Mounting of Filter Inlet Port Onto a Flat Surface”) illustrates an embodiment of a filtration device (FD) and a technique for mounting the filtration device (FD) onto a flat surface, such as the flat surface of a device with a port that emits aerosol such as a nebulizing therapy mask or an oxygen therapy mask (M). Refer also to
The filtration device (FD) is similar to the filtration device (FD) shown at Page 14, but the filtration device (FD) is not designed to fit (slide) onto a tube, such as a nebulizer exhaust tube (NET), with interference fit etc. Rather, the filtration device (FD) is adapted to be mounted (adhered) to the mask (M), by lining up the inlet port (IP) of the filtration device (FD) with a port (P) of the mask (M) and sticking (adhesively mounting) the filtration device (FD) to the mask (M). This works well with a mask (M) having its port (P) on a flat portion of the mask (M).
To effect this mounting technique, a layer of adhesive (AL) may be disposed around the inlet port (IP) of the filtration device (FD). The layer of adhesive may be applied directly to the front surface of the plastic sheet (PS) of the filtration device (FD), around the inlet port (IP).
The layer of adhesive (AL) may be applied to the front plastic sheet (PS) of the filtration device (FD) immediately before assembling the filtration device (FD) to the mask (M). Alternatively, the layer of adhesive (AL) may be applied to the filtration device (FD), and protected by a protective release layer (RL) which may be removed immediately before assembling the filtration device (FD) to the mask. The release layer (RL) may comprise a thin (0.005 in; 0.125 mm thick) layer of paper or plastic liner coated with a silicone release agent, disposed on the exposed (other, opposite, mask) side of the adhesive layer (AL) or element.
The adhesive layer (AL) may be sprayed or “painted” onto the plastic sheet (PS) at the front (mask side) of the filtration device (FD). Alternatively, the adhesive layer (AL) may comprise a thin 2 mil (0.002 in; 0.05 mm) layer of pressure-sensitive adhesive, which is affixed on one side to the plastic sheet (PS) of the filtration device (FD).
The filtration device (FD) may comprise the following elements (components):
The upper (cross-sectional view) illustration on the left-hand side of the page corresponds with
The lower (plan view) illustration on the left-hand side of the page corresponds with
The illustration in the middle of the page shows the filtration device (FD) positioned to be attached (mounted) to a mask (M) having a port (P). To mount the filtration device (FD) to the mask, a user may simply push the filtration device (FD) onto the mask (M).
The illustration on the right-hand side of the page shows the filtration device (FD) attached (mounted) to the mask (M). The “stickie” interface, or adhesive layer (AL) is for mounting the filtration device to the mask, and removably holds the filtration device (FD) in place on the mask with the inlet port (IP) of the filtration device (FD) aligned with the port (P) of the mask, and also forms a seal between the filtration device (FD) and the mask.
In this embodiment of a filtration device (FD), the surface of a mask (M) to which the filtration device (FD) is attached is flat, and it may also be rigid. This embodiment is suitable for use with a mask having its port disposed on a flat, rigid area of the mask. Not all masks will have such a flat, rigid area, and the next two pages (Pages 16, 17) disclose an embodiment of the filtration device (FD) adapted for use with masks that do not have their port disposed on a flat, rigid area of the mask.
Page 16
This page (“Means of Mounting of Filter Inlet Port Onto a Non-Flat Flexible Surface”) illustrates a problem which may be encountered with mounting the filtration device (FD) shown at Page 15 to a non-flat or flexible surface of a mask (M). As illustrated, when the surface of the mask flexes, stresses may be induced at the interface between the front plastic sheet (PS) of the filtration device (FD) and the mask, which may cause the seal at the interface to break and consequent separation of the filtration device (FD) from the mask.
Page 17
This page (“Means of Mounting of Filter Inlet Port Onto a Non-Flat Surface”) illustrates a technique for mounting the filter onto a non-flat surface, such as the non-flat surface of a mask.
See also
The filtration device (FD) is similar to the filtration device (FD) shown at Page 15, but in this embodiment the interface between the filtration device (FD) and the mask (M) comprises a thin (such as 0.006 in; 0.152 mm) flexible substrate (FS), or sheet of a plastic material (such as polyethylene), which may be ring shaped (having an inside diameter and an outside diameter) and affixed (such as welded or adhesively secured) at its inner diameter (or on one side of the flexible sheet) to the plastic sheet (PS) of the filtration device (FD), at the inlet port (IP). An adhesive layer (AL) may be disposed on the mask side of the flexible substrate (FS) for mounting the filtration device (FD) to the mask (M) having a non-rigid or non-flat mounting surface.
The flexible substrate (FS) may be donut-shaped, having an overall outer diameter (OD) and an opening or inner diameter (ID). The flexible substrate may be secured to the front surface of the plastic sheet (PS), with its opening aligned with the inlet port (IP), by welding (or adhesively sticking) the flexible substrate to the plastic sheet, around the inlet port.
The flexible substrate (FS) may be adhered such as by welding to the filtration device (FD), with the central opening of the flexible substrate aligned with the inlet port (IP) of the filtration device (FD). The filtration device (FD), may then be mounted/adhered to the mask, by lining up the inlet port (IP) of the filtration device (FD), with the mask port (P), and sticking the filtration device (FD) to the mask.
The flexible substrate (FS) may first be adhered to the filtration device (FD), with a release layer (RL) protecting the adhesive on the mask side of the flexible substrate (FS). Adhesive on the mask side of the flexible substrate (FS) may be protected by a release layer (as discussed at page 15) which may be removed immediately before assembling (mounting) the filtration device (FD), to the mask (M). In this case, the flexible substrate (FS) and release layer (RL) may be considered to be part of, or a component of the filtration device (FD).
Alternatively, the flexible substrate (FS) could first be adhered to the mask, thereafter the filtration device (FD) being assembled to the mask (M). In this case, a release layer (RL) may be provided on the filtration device (FD) side of the flexible substrate (FS). In this case, the flexible substrate (FS) may be considered to be part of the mask (M).
Alternatively, the flexible substrate may not first be adhered to either the filtration device (FD) or to the mask (M). It may simply be donut shaped, with adhesive on both sides thereof, and a release film on both sides thereof protecting the adhesive, akin to double-sided tape. Then, when assembling the filter to the mask, the release layers on both (filter, mask) sides of the flexible substrate may be removed. In this case, the flexible substrate (FS) may be considered to be associated with the filtration device (FD), although it may be supplied separately therefrom.
Adhesive on the filter side and on the mask side of the flexible substrate (FS) may cover (extend over) only select areas of the flexible substrate radially outward from the central opening in the flexible substrate. For example, on the filter side of the flexible substrate, adhesive may be disposed only on a radially inward portion of the flexible substrate. However, as mentioned above, the flexible substrate may simply and suitably be welded to the front plastic sheet (PS) of the filtration device (FD), at its inlet port (IP). And, on the mask side of the flexible substrate, adhesive may be disposed only on a radially outward portion of the flexible substrate. In other words, the portions of the flexible substrate joined with the filtration device (FD) and the mask (M) may be radially offset from one another, in a sort of cantilever fashion, to allow for the flexible substrate (FS) to flex without compromising the integrity of the adhesive seal between the filtration device (FD) and the mask (M).
It should be noted that the flexible substrate (FS) may be other than donut shaped, and the opening therein may be located other than centrally on the flexible substrate.
The upper (cross-sectional view) illustration on the left-hand side of the page corresponds with
In the embodiments shown in
The lower (plan view) illustration on the left-hand side of the page corresponds with
The illustration in the middle of the page shows the filter positioned to be attached (mounted) to a mask (M) having a port (P). To mount the filter to the mask, a user may simply push the filter onto the mask.
The illustration on the right-hand side of the page shows the filter attached (mounted) to the mask. The “stickie” interface holds the filter in place on the mask, with the inlet ort of the filter aligned with the port of the mask, and forms a seal between the filter and the mask.
Note that, in this embodiment, the mask surface to which the filter is attached in not flat, and it may also not be rigid.
In some embodiments disclosed herein, the use of an adhesive layer (AL) or “stickie” interface (SI) for mounting/attaching) the filtration device (FD) to a mask (M) has been described. A suitable adhesive which can be use for this purpose is 3M 483 Polyethylene Film Tape, is made with same material as the plastic sheet (PS) for bonding compatibility, is stretchable, and the adhesive likes to adhere to surfaces which masks are typically fabricated with, such as vinyl.
This embodiment is suitable for use with a mask having its port disposed on a non-flat and/or flexible area of the mask.
Page 18
This page illustrates some components of an embodiment of the filtration device (FD). In this embodiment, the inlet port (IP) is not concentric with the filter media or element (F, FE).
The illustration on the left-hand side of the page shows (plan view) the following components, individually, prior to assembly of the filtration device (FD):
The filtration device (FD), may be round, more accurately circular or disc-like. Similarly, the plastic sheet (PS), filter media (FM) and sponge element (SE) may all be round. the filter media may have a diameter approximately equal to the diameter of the plastic sheet, such as 4 inches (10 cm). The filtration device (FD) and its individual components may be other than round, such as elliptical, triangular, square, rectangular, or polygon shaped (where the number of sides of the polygon is greater than 4, such as 5, 6 or 8). Other shapes are possible.
In this embodiment, the inlet port of the filtration device (FD) is off-center (or non-concentric) with the circular (disc-like) plastic sheet (PS), filter media (F), and sponge element (S).
The illustration on the right-hand side of the page shows (2 plan views) the “stickie” substrate (SS) and pull tab (PT).
The “stickie” substrate (SS) is shown with a pull tab (PT) and optional protective cover (PC, or release layer RL) over glue (adhesive, AL) on the stickie substrate for protection prior to use. A pull tab cover (PTC) is also shown.
The pull tab (PT) is only the tab portion of the sticky sheet (SS) and optional protective cover (PC). The pull tab cover (PTC) is a separate piece that masks (separates, isolates) the extra adhesive on the tab so the tab on the sticky sheet (SS) and protective cover (PC) are not connected. Easy separation by the user and avoids contamination of the user finger(s) during mounting.
The pull tab (PT) is useful for easy removal of the pull tab cover; plus the removal of the filter assembly from the mask.
The pull tab (PT) allows pulling the filtration device (FD) off the mask (M). In some instances where patients require extended treatments or repeated treatments, saturated filters can be removed and a new filtration device (FD) mounted to eliminate the need to discard the mask.
The pull tab cover (PTC) provides a stickie barrier on the Pull Tab section, so the Pull Tab does not adhere to the mask surface or the user's fingers during mask application.
This comports with the filter embodiment described at Page 17, for a mask having a non-flat surface for attachment of the filter.
The Page 17 embodiment would work on a flat surface also, but complies substantially better with non-flat surfaces than the Page 15 embodiment.
Page 19
This page illustrates the plastic sheet (PS) and “stickie” substrate (SS) components of an embodiment of the filtration device (FD), comporting with the embodiment shown and described at page 17.
In the illustration on the left-hand side of the page, the “stickie” substrate (SS) is shown on the exterior (mask-facing) side of the plastic sheet (PS), the opening in the “stickie” substrate (SS) being aligned with the inlet port (IP) of the filtration device (FD) in the plastic sheet. These openings may be, as shown, off center with the circular plastic sheet (PS), such as asymmetrically biased towards the top portion of the filtration device (FD). This is to allow for the mounting of filtration devices (FD) having larger filter elements (FE) onto masks. The offset allows the filtration devices (FD) to reside toward the front of the mask and further from the back the mask (face interface side) so they do not contact the patient's face when the mask is on the patient.
In the illustration on the right-hand side of the page, the protective cover (PC) is shown pulled back to expose a weld line between the plastic sheet (PS) and the stickie substrate (SS).
Page 20
This page illustrates an embodiment of the filtration device (FD), and shares some features with the embodiment(s) disclosed at Pages 17, 18, 19, hereinabove.
The illustrations on the left-hand side of the page are (i) a plan view (upper illustration) of the filtration device (FD) and (ii) a cross-sectional view (lower illustration) taken on a line A-A through the plan view (upper illustration).
The illustration on the right-hand side of the page is a close-up or detailed cross-sectional view of a portion of the filtration device (FD) shown in the lower illustration on the left-hand side of the page showing the plastic sheet, stickie (flexible) substrate, a weld line where the flexible substrate is welded (joined) to the plastic sheet, and the pull tab.
Page 21
This page illustrates a common respiratory mask (M) with open ports. the close-up view on the right-hand side of the page illustrates that the area around the port on the mask is not flat. The filtration device (FD) embodiment(s) described above at Pages 17, 18, 19, 20 are suitable to be mounted (attached) to such a mask.
Page 22
This page illustrates a filter (or filter assembly), such as described above at Pages 17, 18, 19, 20 mounted to a common respiratory mask (with open ports), such as was shown at page 21.
The mask surfaces around the port cutouts could be flat or curvy (non-flat). Pages 22 and 23 show the same mask from various angles to demonstrate how the embodiment of Pages 17, 18, 19, 20 complies with the mask surface curvature around the ports to create a reliable seal.
The illustration on the left-hand side of the page is an external (front) mask view, showing the filter assembly mounted to the mask.
The illustration on the right-hand side of the page is an internal (rear) mask view, showing the filter assembly mounted to the mask and, more particularly, the interface seal of the filter to the mask.
Page 23
This page illustrates a filter (or filter assembly), such as described above, mounted to a common respiratory mask having a port on a non-flat surface.
The illustration on the left-hand side of the page shows the filter assembly (filtration device), and the flexible (stickie) substrate with pull tab.
The illustration on the right-hand side of the page shows that the flexible (stickie) substrate allows the filtration device to be mounted compliantly to a face mask having a non-flat surface.
While the invention(s) may have been described with respect to a limited number of embodiments, these should not be construed as limitations on the scope of the invention(s), but rather as examples of some of the embodiments of the invention(s). Those skilled in the art may envision other possible variations, modifications, and implementations that are also within the scope of the invention(s), and claims, based on the disclosure(s) set forth herein.
This is a nonprovisional filing of U.S. 63/182,937 filed 2 May 2021, incorporated in its entirety by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 63182937 | May 2021 | US |
