US20170361056A1 - Positive Expiratory Pressure Device - Google Patents
Positive Expiratory Pressure Device Download PDFInfo
- Publication number
- US20170361056A1 US20170361056A1 US15/188,830 US201615188830A US2017361056A1 US 20170361056 A1 US20170361056 A1 US 20170361056A1 US 201615188830 A US201615188830 A US 201615188830A US 2017361056 A1 US2017361056 A1 US 2017361056A1
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- United States
- Prior art keywords
- flow valve
- tubular body
- therapy
- selector
- respiratory
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
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- 238000002644 respiratory therapy Methods 0.000 claims abstract description 18
- 230000000241 respiratory effect Effects 0.000 claims abstract description 11
- 238000003780 insertion Methods 0.000 claims abstract description 8
- 230000037431 insertion Effects 0.000 claims abstract description 8
- 230000001954 sterilising effect Effects 0.000 claims abstract description 7
- 238000000576 coating method Methods 0.000 claims description 21
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- 229920000642 polymer Polymers 0.000 claims description 14
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- 239000004599 antimicrobial Substances 0.000 claims description 9
- XUIMIQQOPSSXEZ-UHFFFAOYSA-N Silicon Chemical compound [Si] XUIMIQQOPSSXEZ-UHFFFAOYSA-N 0.000 claims description 5
- 229910052710 silicon Inorganic materials 0.000 claims description 5
- 239000010703 silicon Substances 0.000 claims description 5
- 239000000047 product Substances 0.000 claims description 4
- 229910001923 silver oxide Inorganic materials 0.000 claims description 3
- NDVLTYZPCACLMA-UHFFFAOYSA-N silver oxide Substances [O-2].[Ag+].[Ag+] NDVLTYZPCACLMA-UHFFFAOYSA-N 0.000 claims description 3
- -1 silver oxide ions Chemical class 0.000 claims description 3
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Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/20—Valves specially adapted to medical respiratory devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
- A61M16/0003—Accessories therefor, e.g. sensors, vibrators, negative pressure
- A61M16/0006—Accessories therefor, e.g. sensors, vibrators, negative pressure with means for creating vibrations in patients' airways
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/20—Closure caps or plugs for connectors or open ends of tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/20—Closure caps or plugs for connectors or open ends of tubes
- A61M2039/205—Closure caps or plugs for connectors or open ends of tubes comprising air venting means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0205—Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/59—Aesthetic features, e.g. distraction means to prevent fears of child patients
Definitions
- the present disclosure relates, in general, to medical devices and more particularly to devices for the removal of pulmonary secretions from the lungs of patients undergoing respiratory treatments.
- pulmonary secretions bronchial mucus
- PEP positive expiratory pressure
- the gentle application of a series of pressure waves additionally provide a percussive effect, reducing the viscoelasticity of the mucus, and dislodging these secretions from the lungs so that they can be expelled (mucocillary clearance).
- OEP oscillatory positive expiratory pressure
- Prior art OPEP devices such as the RC-Cornet® Oscillatory PEP Therapy Device utilize a rotating mouthpiece to adjust the frequency and pressure of the oscillations. These therapy selectors are difficult to adjust, do not stay at the set therapy position, and the settings are difficult to visualize. Further, these therapy selectors are not constrained from partial withdrawal from the OPEP body. Partial withdrawal makes the therapy easier on the patient by reducing the amount of exhalation exertion they have to expend, but alters the physical characteristics of the device such that its efficacy is severely diminished. The current devices lack handles and present an undesirable phallic-like aesthetics.
- the heart of OPEP devices is the silicon polymer flow valve.
- the flow valve Being made of medical grade silicone, the flow valve is extremely hard to install and requires its own tool for replacement.
- the prior art flow valves are completely planar and must be frictionally fit over the distal end of the therapy selector. This is a poor design and lends itself to premature flow valve failure because of splitting and tearing.
- the prior art devices also require sterilization on a frequent basis.
- an improved OPEP device that eliminates all of the prior art downfalls described above would fulfill a long felt need in the respiratory disease treatment industry.
- This new invention utilizes and combines known and new technologies in a unique and novel configuration to overcome the aforementioned problems and accomplish this.
- an improved OPEP device, for respiratory therapy is provided.
- a OPEP device with a flow valve capable of insertion into the curved OPEP body without tools or aids is provided.
- a OPEP device with a tear resistant flow valve incorporating a reinforced proximal end that has been slightly flared is provided.
- a OPEP device having a constrained, adjustable therapy selector that is easy to adjust with clear visual and audible indicators and that prevents patients from minimizing the medical benefits of their respiratory therapy is provided.
- a OPEP device with an easy-remove silicon end cap and an integrated handle is provided.
- an aesthetically appealing, handled OPEP device that has a vented dust cap and a therapy selector dimensioned to accept commercially available, standardized respiratory fittings adaptors, mouthpieces and “Tees” that are capable of connection to multiple respiratory therapy devices or medicated aerosol delivery units, is provided.
- a OPEP device with a self sterilizing flow valve has been provided.
- FIG. 1 is a front perspective view of the improved OPEP device with an optional Tee piece installed:
- FIG. 2 is a front perspective exploded view of the improved OPEP device with the optional Tee piece;
- FIG. 3 is a first side view of the improved OPEP device
- FIG. 4 is a back view of the improved OPEP device
- FIG. 5 is a second side view of the improved OPEP device
- FIG. 6 is a front view of the improved OPEP device
- FIG. 7 is a top view of the improved OPEP device
- FIG. 8 is a bottom view of the improved OPEP device
- FIG. 9 is a perspective first view of the improved OPEP device with the therapy selector selected to the lowest pressure setting
- FIG. 10 is a perspective first view of the improved OPEP device with the therapy selector selected to the highest pressure setting
- FIG. 11 is a front perspective view of the OPEP device
- FIG. 12 is a side perspective view of a flow valve affixed to a therapy selector
- FIG. 13 is distal end view of the therapy selector
- FIG. 14 is a top view of a flow valve
- FIG. 15 is a cross sectional view of a flow valve
- FIG. 16 is a top perspective view of a flow valve
- FIG. 17 is an axial cross sectional view of a flow valve.
- the present invention relates to a novel design for a single patient use improved oscillatory positive exhalation pressure (“OPEP”) device that incorporates numerous enhancements over the prior art in both the aesthetics and functionality of the device. It loosens the bronchial mucus for mucocillary clearance through the application of a series of pressure waves.
- the respiratory therapy with the device 2 is intended to be performed 2 - 3 times per day for 5 minutes or as recommended by a healthcare provider. Increased intervals and prolonged treatment time may be required in cases of increased breathing difficulty or increased mucus accumulation.
- FIGS. 3-8 illustrate that the exterior of the improved OPEP device 2 has a hollow, tubular polymer body 4 having a distal end 6 and a proximal end 8 .
- the length of the body is curved, with the preferred embodiment having an approximate 90 degree curve across the length of it with a tolerance of plus or minus 10 degrees.
- the overall length of the OPEP body is 9.375 inches plus or minus 1 ⁇ 2 inch.
- a flexible, polymer sound dampening cap 10 is frictionally affixed. In the preferred embodiment this cap 10 is made of silicone. This results in a 14% quieter operation.
- the cap 10 has a pair of opposed vent orifices 14 formed there through that allow the exhaled air escape from the OPEP body 4 .
- the cap 10 also has a slight groove 80 about the bottom interior periphery that frictionally engages about a raise ring 82 at the distal end of the OPEP body 4 . This increases the adherence of the cap 10 to the end of the OPEP body 4 .
- On the bottom inner face of the cap is a set of stiffening ribs 22 ( FIG. 2 ) to retain the circular configuration of the cap as the thickness of the silicone used for construction will not allow the cap to retain its shape under its own mass without the stiffening ribs 22 .
- a selectively adjustable therapy selector 12 At the proximal end of the body is rotationally affixed.
- a handle 16 Spanning between the distal end 6 and the proximal end 8 of the body 4 is a handle 16 . It is directly affixed to the OPEP body 4 at both of it ends. ( FIG. 11 ) The handle is arced and is used as a secure holding apparatus for those with diminished grasping abilities, and it is used to change the visual aesthetics, which many testers have commented has a phallic-like resemblance. The positioning of the handle 16 on the body 4 is not designed to position the device in the correct orientation, as the device is not gravity or position sensitive. It may be used with a patient in any position. The handle 16 has a series of raised ribs 18 to increase its gripability. Not visible in FIGS. 3-6 is a flexible polymer flow valve 20 ( FIGS. 12, 14-16 ) which is frictionally affixed to the therapy selector 12 and resides within the OPEP body 4 .
- the structure of the improved OPEP device 2 can best be seen with reference to FIGS. 2 and 12 .
- the of the therapy selector 12 is a hollow linear fitting, circular in cross section, having a distal end 26 and a proximal end 24 .
- the distal end 26 has an outer diameter dimensionally sized to be rotationally and slidingly frictionally received in the opening at the proximal end of the OPEP body 4 .
- the proximal end 24 of the therapy selector 12 has an outer diameter sized to be received in other respiratory adaptors and devices such as a mouthpiece.
- the proximal end also has an inner diameter sized to receive other respiratory adaptors.
- FIGS. 1 and 2 the OPEP device is shown coupled to a Tee adaptor 30 which has a 22 mm inner diameter connecting leg 33 that slides over the 22 mm outer diameter of the proximal end of the therapy selector 12 .
- the mouthpiece has an 18 mm outer diameter that engages frictionally with the inner diameter of the proximal end of the therapy selector.
- the flow valve 20 is a hollow linear tube made of a polymer, preferably a medical grade silicone. It is replaceable, washable and can be sterilized.
- the valve 20 has a planar, linear body of two substantially similar, parallel planar strips joined at both their long side edges. It has a proximal end and a distal end, with the proximal end molded into a cone 34 , terminating in a circular cross section.
- a raised, strengthening ring to resist tears from propagating from the tip of the proximal end when the valve 20 is stretched into place.
- the inner diameter of the cone is smaller than the outer diameter of the bottom section of the therapy selector such that it can frictionally remain engaged thereon. It has a pair of raised ribs 36 and an arrow 38 embossed on it surface.
- the ribs 36 help when stretching the cone 34 over the exterior of the bottom section of the therapy selector 12 , and the arrow 38 informs the patient which end of the flow valve 20 is to go onto the therapy selector 12 .
- the flow valve 20 is made to exacting tolerances to fit and work within the OPEP body.
- the OPEP body has an inside diameter of varying size ranging from one inch to 0.900 inches and a length of approximately nine and 3 ⁇ 8 inches plus or minus 1 ⁇ 2 inch.
- the flow valve 20 has a width (denoted as X) of 0.886 inches plus or minus 0.25 inches, and a length (denoted as Y) of 5.984 inches plus or minus 1 ⁇ 2 inches.
- the amount of clearance between the flow valve's sides and the inside wall of the OPEP body may be as large as 1 ⁇ 4 inch is but generally is less that 1/64 of an inch at the narrowest.
- the wall thickness of the flow valve (denoted as V) is 0.017 inches plus or minus 0.010 inches and the space between the parallel walls (denoted as W) is 0.011 inches plus or minus 0.005 inches.
- the diameter of the cone 34 is 0.560 inches plus or minus 0.025 inches.
- On the outer surface of the flow valve 20 is a coating of a lubricating polymer 40 . This polymer 40 is not coated onto the interior of the flow valve 20 . The polymer 40 allows for the insertion of the flow valve 20 into the OPEP body 4 without any tools.
- This outer, low density polymer coating is any of a variety of poly polymers commonly used as dry film lubricants. These matte coatings may be chemically bonded or physically bonded to the surface. Since they affect both the mass and the durometer of the flow valve 20 which in turn affects the frequency and pressure of the oscillatory pressure wave, they are extremely thin coatings.
- any of the family of Parylene® (poly(para-xylylene) polymers), is used here which physically bonds well to medical grade silicone and results in a matte surface that has a very low coefficient of friction with the smooth polymer the OPEP body 4 is made of.
- This is applied in a vapor deposition tumbling apparatus to a thickness of approximately 0.5 microns with a tolerance of plus or minus 0.2 microns.
- This coating increases the rubber material hardness of the flow valve 20 .
- the material hardness of the flow valve with the applied coating (including any anti-microbial product) must remain in the 30-40 range of the Type A durometer scale based on the ASTM D2240 standard.
- the flow valve 20 will not close after a bubble of air has exited and there will not be the generation of a series of pressure pulses. If the material hardness is too high, (over 40) the pressure required to push the air out of the distil edge is too high and the bubble size is too large diminishing the frequency.
- a nano sized dry lubricant such as Slick Sil LSR® containing an anti- microbial FluroMed® with silver oxide ions is used.
- This particular coating combination does not affect the material hardness and is applied chemically.
- the anti microbial feature eliminated or minimizes the requirement for repeated, regular sterilizations.
- the problem of accumulated pathogens in the moist environment of the device is a huge potential liability of using the OPEP device, especially for patients with cystic fibrosis. It is to be noted that the interior of the flow valve will not be coated or treated with a dry lubricant, however it will receive the anti microbial coating.
- an anti-microbial product may be physically integrated into the fabrication of the silicon such that the flow valve undergoes constant sterilization.
- This dry film lubricity allows the rapid insertion and removal of a flow valve 20 without any tools. Without this coating, the flow valve will not install into the OPEP body without a tool.
- the thickness of the coating onto the flow valve 20 is balanced between its dry lubricity factors and the effect the added weight and material hardness will have on the functionality of the flow valve 20 .
- the flow valve 20 is formed by injection molding about a planar “knife” that the flow valve 20 is formed around.
- the knife is supported along its length during the molding process by a series of extremely slender pins that contact the knife and stabilize it from sag or droop.
- the flow valve wall thickness is approximately 0.017 inches plus or minus 0.005 inches. This ensures that the correct pressure oscillations are generated. (The overall effect of a coating increases the frequency of the pressure waves by approximately 1 Hz because of the effect it has on the material hardness)
- the holes left by the pins in the walls have a negligible effect on the function of the device.
- the flow valve 20 hangs off of the therapy selector 12 , with its cone 34 stretched over the bottom section.
- the flow valve 20 lies in the OPEP body 4 such that one of its parallel walls may lay against inner wall of the OPEP body 4 .
- the pressure in the flow valve 20 rises and the flow valve buckles at the bend of the OPEP body 4 .
- the distal end of the flow valve opens and these air pockets exit the valve catapulting the end of the flow valve against the wall, releasing its pressure.
- This process is repeated, providing an oscillation effect at a constant pressure and flow-rate during the entire exhalation phase that is exerted into the patient's lungs as oscillatory positive expiratory pressure “OPEP”.
- This has both a pressure and a frequency that can be adjusted by the twist in the flow valve 20 .
- the indicating arrow shows which operational pressure level has been selected.
- the flow valve 20 will twist to a helix-like configuration but it will not straighten upon use because of the tolerances involved.
- the more extreme the helix-like twist in the flow valve along with more of the valve being bent the larger the bubbles and more tortious the path requiring more exhalation pressure and resulting in a lower frequency of pressure pulses but a higher force of the back pressure wave.
- the straighter and less curved the flow valve 20 the smaller the air bubbles and the less exhaust pressure required with a resultant higher frequency and lower force of back pressure waves.
- the preferred embodiment remedies this situation with a therapy selector withdrawal lock.
- Extending normally from the bottom section of the therapy selector is a pin 60 that fits into a slot 62 cut into the OPEP body 4 adjacent the proximal end. This allows the rotation of the therapy selector 12 for the purpose of selecting the desired level of therapy but prevents the withdrawal of the therapy selector 12 from the proximal end of the OPEP body 4 .
- the pin 60 ( FIGS. 2 and 13 ) is inserted into the corresponding orifice in the therapy selector 12 after the therapy selector 12 is inserted into the OPEP body 4 and the orifice aligned with the slot 62 .
- FIG. 3 In an alternate embodiment ( FIG. 2 ) there is a groove 64 running from the proximal end of the OPEP body 4 into the slot 62 (preferably in a perpendicular line) that then allows the insertion of the therapy selector 12 with the pin 60 already installed therein, into the slot 62 .
- the therapy selector withdrawal lock of the preferred embodiment may not be removed without the pin 60 being pushed through the therapy selector, while the alternate embodiment therapy selector withdrawal lock allows the therapy selector to be withdrawn by rotation, but does not allow it to be withdrawn when it is engaged in any one of the therapy selections.
- the anti-microbial additive With the addition of the anti-microbial additive, removal of the therapy selector to get at the flow valve for sterilization is not necessary, allowing for the use of the first embodiment therapy selector withdrawal lock.
- the therapy selector 12 has a raised linear rib 30 on its outside bottom section that matingly, and rotationally engages any one of a series of slots 32 formed on the inside surface of the proximal end of the OPEP body 4 .
- Rotating the therapy selector to engage the various slots 32 on the OPEP body 4 increases the amount of twist the flow valve experiences inside the OPEP body. This in turn adjusts the pressure and frequency of oscillations.
- FIGS. 9 and 10 show the therapy selector set for the lowest and highest levels of therapy.
- the length of the flow valve 20 has been set to approximately six inches (5.984 inches) so as to provide a well gradated series of therapy settings that provide for a lowest setting of only a flat valve that bends in conformance with the radius of the curve in the OPEP body.
- the remainder of settings have some degree of helical twist along the length of the flow valve.
- the lowest therapy selector setting cannot be bypassed by the patient by partial withdrawal of the therapy selector.
- the overall design and structure of the device 2 provides an extremely high level of consistency in the therapy sessions not seen before in any of the prior art devices.
- the following table sets forth the average pressure, average pressure amplitude and the frequency of pulses for three different fixed flow rates, taken across all therapy settings of the therapy selector.
- the combination of a flow valve that is fabricated with a wall thickness having a tolerance of 0.010 inches and with the space between parallel walls having a tolerance of 0.005 inches, allows a dry lubricant coating to be placed on the exterior surfaces and still maintain a material hardness between 30 and 40 durometer, so as to allow the following pressure and frequency ranges.
- Cleaning a non anti-microbial treated OPEP device 2 should be performed every other day and may be accomplished by disassembly and hand washing with a gentle soap. Disinfecting the components of the OPEP device 2 may be accomplished by immersion in boiling water for 10 minutes and air drying thereafter.
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Abstract
Description
- A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever.
- The present disclosure relates, in general, to medical devices and more particularly to devices for the removal of pulmonary secretions from the lungs of patients undergoing respiratory treatments.
- When treating patients with respiratory secretions problems, such as Cystic Fibrosis, asthma, COPD and the like, it is advantageous to help clear the patient's lungs of the pulmonary secretions (bronchial mucus) thereon. These can be dislodged best by a series of two different therapies. First, a positive expiratory pressure (PEP) is exerted back into the lungs increasing air pressure into the bronchi and pulmonary alveoli. This pressure prevents airway collapse by stenting the airways, or increasing intrathoracic pressure distal to retained secretions, by collateral ventilation or by increasing functional residual capacity. Second, the gentle application of a series of pressure waves (oscillatory vibrations) additionally provide a percussive effect, reducing the viscoelasticity of the mucus, and dislodging these secretions from the lungs so that they can be expelled (mucocillary clearance).
- This can be accomplished with an oscillatory positive expiratory pressure (“OPEP”) device that uses the patient's own breathing to generate a series of pressure waves with each exhalation cycle, that causes the thorax to vibrate and loosen the mucus so that it may be expelled.
- Prior art OPEP devices, such as the RC-Cornet® Oscillatory PEP Therapy Device utilize a rotating mouthpiece to adjust the frequency and pressure of the oscillations. These therapy selectors are difficult to adjust, do not stay at the set therapy position, and the settings are difficult to visualize. Further, these therapy selectors are not constrained from partial withdrawal from the OPEP body. Partial withdrawal makes the therapy easier on the patient by reducing the amount of exhalation exertion they have to expend, but alters the physical characteristics of the device such that its efficacy is severely diminished. The current devices lack handles and present an undesirable phallic-like aesthetics. The heart of OPEP devices is the silicon polymer flow valve. Being made of medical grade silicone, the flow valve is extremely hard to install and requires its own tool for replacement. The prior art flow valves are completely planar and must be frictionally fit over the distal end of the therapy selector. This is a poor design and lends itself to premature flow valve failure because of splitting and tearing. The prior art devices also require sterilization on a frequent basis.
- Henceforth, an improved OPEP device that eliminates all of the prior art downfalls described above would fulfill a long felt need in the respiratory disease treatment industry. This new invention utilizes and combines known and new technologies in a unique and novel configuration to overcome the aforementioned problems and accomplish this.
- In accordance with various embodiments, an improved OPEP device, for respiratory therapy is provided.
- In one aspect, a OPEP device with a flow valve capable of insertion into the curved OPEP body without tools or aids is provided.
- In another aspect, a OPEP device with a tear resistant flow valve incorporating a reinforced proximal end that has been slightly flared, is provided.
- In yet another aspect, a OPEP device having a constrained, adjustable therapy selector that is easy to adjust with clear visual and audible indicators and that prevents patients from minimizing the medical benefits of their respiratory therapy is provided.
- In yet another aspect, a OPEP device with an easy-remove silicon end cap and an integrated handle is provided.
- In yet another aspect, an aesthetically appealing, handled OPEP device that has a vented dust cap and a therapy selector dimensioned to accept commercially available, standardized respiratory fittings adaptors, mouthpieces and “Tees” that are capable of connection to multiple respiratory therapy devices or medicated aerosol delivery units, is provided.
- In a final aspect, a OPEP device with a self sterilizing flow valve has been provided.
- Various modifications and additions can be made to the embodiments discussed without departing from the scope of the invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combination of features and embodiments that do not include all of the above described features.
- A further understanding of the nature and advantages of particular embodiments may be realized by reference to the remaining portions of the specification and the drawings, in which like reference numerals are used to refer to similar components
-
FIG. 1 is a front perspective view of the improved OPEP device with an optional Tee piece installed: -
FIG. 2 is a front perspective exploded view of the improved OPEP device with the optional Tee piece; -
FIG. 3 is a first side view of the improved OPEP device; -
FIG. 4 is a back view of the improved OPEP device; -
FIG. 5 is a second side view of the improved OPEP device; -
FIG. 6 is a front view of the improved OPEP device; -
FIG. 7 is a top view of the improved OPEP device; -
FIG. 8 is a bottom view of the improved OPEP device; -
FIG. 9 is a perspective first view of the improved OPEP device with the therapy selector selected to the lowest pressure setting; -
FIG. 10 is a perspective first view of the improved OPEP device with the therapy selector selected to the highest pressure setting; -
FIG. 11 is a front perspective view of the OPEP device; -
FIG. 12 is a side perspective view of a flow valve affixed to a therapy selector; -
FIG. 13 is distal end view of the therapy selector; -
FIG. 14 is a top view of a flow valve; -
FIG. 15 is a cross sectional view of a flow valve; -
FIG. 16 is a top perspective view of a flow valve; and -
FIG. 17 is an axial cross sectional view of a flow valve. - While various aspects and features of certain embodiments have been summarized above, the following detailed description illustrates a few exemplary embodiments in further detail to enable one skilled in the art to practice such embodiments. The described examples are provided for illustrative purposes and are not intended to limit the scope of the invention.
- In the following description, for the purposes of explanation, numerous specific details are set forth in order to provide a thorough understanding of the described embodiments. It will be apparent to one skilled in the art, however, that other embodiments of the present invention may be practiced without some of these specific details. While various features are ascribed to different embodiments, it should be appreciated that the features described with respect to one embodiment may be incorporated with other embodiments as well. By the same token, however, no single feature or features of any described embodiment should be considered essential to every embodiment of the invention, as other embodiments of the invention may omit such features.
- Unless otherwise indicated, all numbers herein used to express quantities, dimensions, and so forth, should be understood as being modified in all instances by the term “about.” In this application, the use of the singular includes the plural unless specifically stated otherwise, and use of the terms “and” and “or” means “and/or” unless otherwise indicated. Moreover, the use of the term “including,” as well as other forms, such as “includes” and “included,” should be considered non-exclusive. Also, terms such as “element” or “component” encompass both elements and components comprising one unit and elements and components that comprise more than one unit, unless specifically stated otherwise.
- The present invention relates to a novel design for a single patient use improved oscillatory positive exhalation pressure (“OPEP”) device that incorporates numerous enhancements over the prior art in both the aesthetics and functionality of the device. It loosens the bronchial mucus for mucocillary clearance through the application of a series of pressure waves. The respiratory therapy with the
device 2 is intended to be performed 2-3 times per day for 5 minutes or as recommended by a healthcare provider. Increased intervals and prolonged treatment time may be required in cases of increased breathing difficulty or increased mucus accumulation. -
FIGS. 3-8 illustrate that the exterior of theimproved OPEP device 2 has a hollow,tubular polymer body 4 having adistal end 6 and aproximal end 8. The length of the body is curved, with the preferred embodiment having an approximate 90 degree curve across the length of it with a tolerance of plus or minus 10 degrees. The overall length of the OPEP body is 9.375 inches plus or minus ½ inch. About the outer perimeter of the distal end a flexible, polymersound dampening cap 10 is frictionally affixed. In the preferred embodiment thiscap 10 is made of silicone. This results in a 14% quieter operation. Thecap 10 has a pair ofopposed vent orifices 14 formed there through that allow the exhaled air escape from theOPEP body 4. Thecap 10 also has aslight groove 80 about the bottom interior periphery that frictionally engages about araise ring 82 at the distal end of theOPEP body 4. This increases the adherence of thecap 10 to the end of theOPEP body 4. On the bottom inner face of the cap is a set of stiffening ribs 22 (FIG. 2 ) to retain the circular configuration of the cap as the thickness of the silicone used for construction will not allow the cap to retain its shape under its own mass without the stiffeningribs 22. At the proximal end of the body is rotationally affixed a selectivelyadjustable therapy selector 12. - Spanning between the
distal end 6 and theproximal end 8 of thebody 4 is ahandle 16. It is directly affixed to theOPEP body 4 at both of it ends. (FIG. 11 ) The handle is arced and is used as a secure holding apparatus for those with diminished grasping abilities, and it is used to change the visual aesthetics, which many testers have commented has a phallic-like resemblance. The positioning of thehandle 16 on thebody 4 is not designed to position the device in the correct orientation, as the device is not gravity or position sensitive. It may be used with a patient in any position. Thehandle 16 has a series of raisedribs 18 to increase its gripability. Not visible inFIGS. 3-6 is a flexible polymer flow valve 20 (FIGS. 12, 14-16 ) which is frictionally affixed to thetherapy selector 12 and resides within theOPEP body 4. - The structure of the
improved OPEP device 2 can best be seen with reference toFIGS. 2 and 12 . The of thetherapy selector 12 is a hollow linear fitting, circular in cross section, having adistal end 26 and aproximal end 24. (FIGS. 2 and 12 ) Thedistal end 26 has an outer diameter dimensionally sized to be rotationally and slidingly frictionally received in the opening at the proximal end of theOPEP body 4. Theproximal end 24 of thetherapy selector 12 has an outer diameter sized to be received in other respiratory adaptors and devices such as a mouthpiece. The proximal end also has an inner diameter sized to receive other respiratory adaptors. Since the medical industry has standardized dimensions for the internal and external connections of the majority of its commercially available devices, these dimensions (generally 18 and 22 mm) are what the preferred embodiment therapy selector is sized to. InFIGS. 1 and 2 the OPEP device is shown coupled to aTee adaptor 30 which has a 22 mm innerdiameter connecting leg 33 that slides over the 22 mm outer diameter of the proximal end of thetherapy selector 12. The mouthpiece has an 18 mm outer diameter that engages frictionally with the inner diameter of the proximal end of the therapy selector. - Looking at
FIGS. 14-17 one can see that theflow valve 20 is a hollow linear tube made of a polymer, preferably a medical grade silicone. It is replaceable, washable and can be sterilized. Thevalve 20 has a planar, linear body of two substantially similar, parallel planar strips joined at both their long side edges. It has a proximal end and a distal end, with the proximal end molded into acone 34, terminating in a circular cross section. At the proximal tip of thevalve 20 is a raised, strengthening ring to resist tears from propagating from the tip of the proximal end when thevalve 20 is stretched into place. The inner diameter of the cone is smaller than the outer diameter of the bottom section of the therapy selector such that it can frictionally remain engaged thereon. It has a pair of raisedribs 36 and anarrow 38 embossed on it surface. Theribs 36 help when stretching thecone 34 over the exterior of the bottom section of thetherapy selector 12, and thearrow 38 informs the patient which end of theflow valve 20 is to go onto thetherapy selector 12. - The
flow valve 20 is made to exacting tolerances to fit and work within the OPEP body. The OPEP body has an inside diameter of varying size ranging from one inch to 0.900 inches and a length of approximately nine and ⅜ inches plus or minus ½ inch. Theflow valve 20 has a width (denoted as X) of 0.886 inches plus or minus 0.25 inches, and a length (denoted as Y) of 5.984 inches plus or minus ½ inches. As can be seen, the amount of clearance between the flow valve's sides and the inside wall of the OPEP body may be as large as ¼ inch is but generally is less that 1/64 of an inch at the narrowest. The wall thickness of the flow valve (denoted as V) is 0.017 inches plus or minus 0.010 inches and the space between the parallel walls (denoted as W) is 0.011 inches plus or minus 0.005 inches. The diameter of thecone 34 is 0.560 inches plus or minus 0.025 inches. On the outer surface of theflow valve 20 is a coating of a lubricatingpolymer 40. Thispolymer 40 is not coated onto the interior of theflow valve 20. Thepolymer 40 allows for the insertion of theflow valve 20 into theOPEP body 4 without any tools. Without thepolymer 40, upon insertion, theflow valve 20 will hang up in the inside of theOPEP body 4 both by the friction of its sides against the OPEP body walls and by its planar walls on the bend of theOPEP body 4. This outer, low density polymer coating is any of a variety of poly polymers commonly used as dry film lubricants. These matte coatings may be chemically bonded or physically bonded to the surface. Since they affect both the mass and the durometer of theflow valve 20 which in turn affects the frequency and pressure of the oscillatory pressure wave, they are extremely thin coatings. - In the preferred embodiment any of the family of Parylene® (poly(para-xylylene) polymers), is used here which physically bonds well to medical grade silicone and results in a matte surface that has a very low coefficient of friction with the smooth polymer the
OPEP body 4 is made of. This is applied in a vapor deposition tumbling apparatus to a thickness of approximately 0.5 microns with a tolerance of plus or minus 0.2 microns. This coating increases the rubber material hardness of theflow valve 20. The material hardness of the flow valve with the applied coating (including any anti-microbial product) must remain in the 30-40 range of the Type A durometer scale based on the ASTM D2240 standard. If the material hardness is too low, (below 30) theflow valve 20 will not close after a bubble of air has exited and there will not be the generation of a series of pressure pulses. If the material hardness is too high, (over 40) the pressure required to push the air out of the distil edge is too high and the bubble size is too large diminishing the frequency. - In another embodiment a nano sized dry lubricant such as Slick Sil LSR® containing an anti- microbial FluroMed® with silver oxide ions is used. This particular coating combination does not affect the material hardness and is applied chemically. The anti microbial feature eliminated or minimizes the requirement for repeated, regular sterilizations. The problem of accumulated pathogens in the moist environment of the device, is a huge potential liability of using the OPEP device, especially for patients with cystic fibrosis. It is to be noted that the interior of the flow valve will not be coated or treated with a dry lubricant, however it will receive the anti microbial coating.
- In a further embodiment, an anti-microbial product may be physically integrated into the fabrication of the silicon such that the flow valve undergoes constant sterilization.
- This dry film lubricity allows the rapid insertion and removal of a
flow valve 20 without any tools. Without this coating, the flow valve will not install into the OPEP body without a tool. The thickness of the coating onto theflow valve 20 is balanced between its dry lubricity factors and the effect the added weight and material hardness will have on the functionality of theflow valve 20. There are plugs inserted into the ends of theflow valve 20 during the coating process to ensure that no coating gets onto the inside of theflow valve 20 as this would cause an increase in the frequency of the pressure oscillations. - The
flow valve 20 is formed by injection molding about a planar “knife” that theflow valve 20 is formed around. To ensure that the thicknesses of the two walls of thevalve 20 do not vary considerably from each other, the knife is supported along its length during the molding process by a series of extremely slender pins that contact the knife and stabilize it from sag or droop. In the preferred embodiment the flow valve wall thickness is approximately 0.017 inches plus or minus 0.005 inches. This ensures that the correct pressure oscillations are generated. (The overall effect of a coating increases the frequency of the pressure waves by approximately 1 Hz because of the effect it has on the material hardness) The holes left by the pins in the walls have a negligible effect on the function of the device. - In operation, the
flow valve 20 hangs off of thetherapy selector 12, with itscone 34 stretched over the bottom section. Theflow valve 20 lies in theOPEP body 4 such that one of its parallel walls may lay against inner wall of theOPEP body 4. When the patient exhales through the proximal end of thetherapy selector 12, air travels down theflat flow valve 20 but the bend in theflow valve 20 pinches air off into pockets that traverse down the length of the flow valve and exit the distal end. The pressure in theflow valve 20 rises and the flow valve buckles at the bend of theOPEP body 4. When the peak pressure is reached, the distal end of the flow valve opens and these air pockets exit the valve catapulting the end of the flow valve against the wall, releasing its pressure. This process is repeated, providing an oscillation effect at a constant pressure and flow-rate during the entire exhalation phase that is exerted into the patient's lungs as oscillatory positive expiratory pressure “OPEP”. This has both a pressure and a frequency that can be adjusted by the twist in theflow valve 20. - When the
therapy selector 12 is rotated the indicating arrow shows which operational pressure level has been selected. This twists theflow valve 20 along its length. Theflow valve 20 will twist to a helix-like configuration but it will not straighten upon use because of the tolerances involved. The more extreme the helix-like twist in the flow valve along with more of the valve being bent, the larger the bubbles and more tortious the path requiring more exhalation pressure and resulting in a lower frequency of pressure pulses but a higher force of the back pressure wave. Similarly, the straighter and less curved theflow valve 20 the smaller the air bubbles and the less exhaust pressure required with a resultant higher frequency and lower force of back pressure waves. - Since the amount of the
flow valve 20 that is bent affects the pressure and frequency, withdrawing theflow valve 20 up theOPEP body 4 by pulling out the bottom section oftherapy selector 12 somewhat from the proximal end of theOPEP body 4 will reduce the pressure and the frequency of the oscillatory pulses. This was a huge problem with patients using thedevice 2 on their own. Since it is hard for some these respiratory patients to perform their therapy at the prescribed therapeutic settings because of the massive amount of bronchial mucus in their lungs, they cheat! They withdraw the therapy selector partially from theOPEP body 4 reducing the effort they have to expel. Unfortunately, this does not provide sufficient oscillatory vibrations for effective mucocillary clearance. Thus, the full benefit of the therapy is lost. This has been countered by a physical barrier to cheating. - The preferred embodiment remedies this situation with a therapy selector withdrawal lock. Extending normally from the bottom section of the therapy selector is a
pin 60 that fits into aslot 62 cut into theOPEP body 4 adjacent the proximal end. This allows the rotation of thetherapy selector 12 for the purpose of selecting the desired level of therapy but prevents the withdrawal of thetherapy selector 12 from the proximal end of theOPEP body 4. - In a first embodiment the pin 60 (
FIGS. 2 and 13 ) is inserted into the corresponding orifice in thetherapy selector 12 after thetherapy selector 12 is inserted into theOPEP body 4 and the orifice aligned with theslot 62. (FIG. 3 ) In an alternate embodiment (FIG. 2 ) there is agroove 64 running from the proximal end of theOPEP body 4 into the slot 62 (preferably in a perpendicular line) that then allows the insertion of thetherapy selector 12 with thepin 60 already installed therein, into theslot 62. The therapy selector withdrawal lock of the preferred embodiment may not be removed without thepin 60 being pushed through the therapy selector, while the alternate embodiment therapy selector withdrawal lock allows the therapy selector to be withdrawn by rotation, but does not allow it to be withdrawn when it is engaged in any one of the therapy selections. With the addition of the anti-microbial additive, removal of the therapy selector to get at the flow valve for sterilization is not necessary, allowing for the use of the first embodiment therapy selector withdrawal lock. - The
therapy selector 12 has a raisedlinear rib 30 on its outside bottom section that matingly, and rotationally engages any one of a series ofslots 32 formed on the inside surface of the proximal end of theOPEP body 4. Rotating the therapy selector to engage thevarious slots 32 on theOPEP body 4 increases the amount of twist the flow valve experiences inside the OPEP body. This in turn adjusts the pressure and frequency of oscillations. There are a series of differentheight setting ribs 54 embossed on the outsidecentral section 52 that are spatially aligned with the various slots on theOPEP body 32. There is a highly visible indicatingarrow 50 imprinted on the proximal end of the OPEP body that will align with the settingribs 54 so as to present to the user what operational level of therapy is being performed.FIGS. 9 and 10 show the therapy selector set for the lowest and highest levels of therapy. - The length of the
flow valve 20 has been set to approximately six inches (5.984 inches) so as to provide a well gradated series of therapy settings that provide for a lowest setting of only a flat valve that bends in conformance with the radius of the curve in the OPEP body. The remainder of settings have some degree of helical twist along the length of the flow valve. However, the lowest therapy selector setting cannot be bypassed by the patient by partial withdrawal of the therapy selector. - The overall design and structure of the
device 2 provides an extremely high level of consistency in the therapy sessions not seen before in any of the prior art devices. The following table sets forth the average pressure, average pressure amplitude and the frequency of pulses for three different fixed flow rates, taken across all therapy settings of the therapy selector. The combination of a flow valve that is fabricated with a wall thickness having a tolerance of 0.010 inches and with the space between parallel walls having a tolerance of 0.005 inches, allows a dry lubricant coating to be placed on the exterior surfaces and still maintain a material hardness between 30 and 40 durometer, so as to allow the following pressure and frequency ranges. -
Flow Rate Parameters 10 lpm 20 lpm 40 lpm Ave. Pressure (cmH2O) 10-13 18-21 27-41 Ave. Pressure Amplitude (cmH2O 7-17 22-28 51-76 Frequency (Hz) 8-16 12-17 19-22 - Cleaning a non anti-microbial treated
OPEP device 2 should be performed every other day and may be accomplished by disassembly and hand washing with a gentle soap. Disinfecting the components of theOPEP device 2 may be accomplished by immersion in boiling water for 10 minutes and air drying thereafter. - While certain features and aspects have been described with respect to exemplary embodiments, one skilled in the art will recognize that numerous modifications are possible. For example, the methods and processes described herein may be implemented using hardware components, software components, and/or any combination thereof. Further, while various methods and processes described herein may be described with respect to particular structural and/or functional components for ease of description, methods provided by various embodiments are not limited to any particular structural and/or functional architecture, but instead can be implemented on any suitable hardware, firmware, and/or software configuration. Similarly, while certain functionality is ascribed to certain system components, unless the context dictates otherwise, this functionality can be distributed among various other system components in accordance with the several embodiments.
- Moreover, while the procedures of the methods and processes described herein are described in a particular order for ease of description, unless the context dictates otherwise, various procedures may be reordered, added, and/or omitted in accordance with various embodiments. Moreover, the procedures described with respect to one method or process may be incorporated within other described methods or processes; likewise, system components described according to a particular structural architecture and/or with respect to one system may be organized in alternative structural architectures and/or incorporated within other described systems. Hence, while various embodiments are described with—or without—certain features for ease of description and to illustrate exemplary aspects of those embodiments, the various components and/or features described herein with respect to a particular embodiment can be substituted, added, and/or subtracted from among other described embodiments, unless the context dictates otherwise. Consequently, although several exemplary embodiments are described above, it will be appreciated that the invention is intended to cover all modifications and equivalents within the scope of the following claims.
Claims (17)
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US20200061315A1 (en) * | 2018-08-23 | 2020-02-27 | R. Cegla Gmbh & Co. Kg | Ventilating appliance |
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