BR112015001073B1 - METHOD OF PERFORMING IN VITRO FERTILIZATION ("IVF"), METHOD OF OBTAINING A CINICAL PREGNANCY RATE OF IVF OF AT LEAST 50% AND METHOD OF PURIFYING AIR - Google Patents

Abstract

method of performing in vitro fertilization ("ivf"), method of obtaining a cynical ivf pregnancy rate of at least 50% and method of purifying air. the present invention relates to purified air, which has a tvoc content of less than 5 ppb to approximately 500 ppb, a biological content of less than cfu / m3 to 150 cfu / m3, and a particulate content of approximately 1,000 0.3 (mi) m particles per foot3 to approximately 50,000 0.3 (mi) m particles per foot3, or from approximately 600 0.5 (mi) m particles per foot to approximately 500,000 0.5 (mi) m particles per foot3.

Description

BACKGROUND OF THE INVENTION

[0001] This PCT application claims the benefit under 35 USC §120 of United States Application Number 13 / 554,366, filed on July 20, 2012, which is partly a continuation of US Patent Application Number 13 / 244,973, filed on September 26, 2011, which is a continuation of US Patent Application Number 12 / 732,246, filed on March 26, 2010. International Application Number PCT / US2011 / 029567, filed on March 23, 2011, claims priority of US Patent Application Number 12 / 732,246.

FIELD OF THE INVENTION

[0002] The present invention relates to devices and methods for the filtration and purification of air. More specifically, this invention relates to air purifiers capable of providing an adequate level of air quality for environments that are highly sensitive to airborne contaminants, for example, in vitro fertilization laboratories or other medical environments. In addition, the invention can be adapted for use in any substantially enclosed environment, including, but not limited to, residences, residential buildings, commercial buildings, hotels, cars, buses, trains, airplanes, cruise ships, educational facilities, offices, and government buildings. The invention may also have applications in, for example, national security, defense, or airline industries.

DESCRIPTION OF RELATED TECHNIQUE

[0003] In vitro fertilization ("IVF") is a procedure whereby egg cells are fertilized by sperm in a laboratory environment, rather than in the uterus. If an egg cell is successfully fertilized, it can be transferred into the uterus of a patient who wants to become pregnant.

[0004] IVF can be an effective option for patients suffering from infertility, especially where other methods of assisted reproduction have failed. However, IVF is very expensive and is not typically covered by medical insurance. In 2009, the cost of a single IVF cycle was approximately $ 10,000 to $ 15,000 in the United States. It is financially prohibitive for most people to undergo multiple rounds of IVF. It is therefore imperative that the conditions for successful preimplantation embryogenesis are optimized in order to maximize the likelihood of success.

[0005] An extremely important factor that contributes to the probability of successful pre-implantation embryogenesis is the air quality of the IVF laboratory. Gametes and embryos grown in vitro are highly sensitive to environmental influences. Human embryos have no means of protection or filtration against environmental toxins and pathogens. These are completely at the mercy of their environment. The incubators that house human embryos often consist of a significant percentage of ambient air. Although airborne contaminants can adversely affect embryogenesis, surprisingly little emphasis has been placed on optimizing laboratory air quality during the past three decades in which IVF has been available as a treatment for infertility.

[0006] The existing filtration devices were considered insufficient to optimize the air quality to truly acceptable levels for IVF. For example, it was found that laboratory air that was filtered with high efficiency particulate air filters ("HEPA") was actually of a lower quality than outside air. In addition, some filters produce by-products or other contaminants that actually impair air quality in an IVF laboratory. For example, carbon filters can create carbon dust that is detrimental to the IVF process. This is not to say, however, that carbon filters or HEPA filters should not be used to treat the air supplied to an IVF laboratory. On the contrary, it is preferred that carbon filters, HEPA filters, or their equivalents, are included among the filtration media used to treat the air supplied to an IVF laboratory. Achieving optimum air quality in an IVF laboratory or other substantially enclosed space requires an appropriate selection, combination and sequencing of various filter media.

BRIEF SUMMARY OF THE INVENTION

[0007] Consequently, an air characterized by very high purity and methods for making and using such air, are provided.

[0008] In one aspect of the present invention, air is provided, characterized by a TVOC content of less than 5 ppb to approximately 500 ppb, a Biological content of less than CFU / M3 to 150 CFU / M3 and a particulate content from approximately 1,000 0.3 μm particles per foot3 to approximately 50,000 0.3 μm particles per foot3, or from approximately 600 0.5 μm particles per foot3 to approximately 500,000 0.5 μm particles per foot3.

[0009] Another aspect of the present invention is a method of obtaining a cynical IVF pregnancy rate of at least 50%. The method includes running multiple IVF cycles in an IVF laboratory that has an air characterized by a TVOC content of less than 5 ppb to approximately 500 ppb, a Biological content of less than 1 CFU / M3 to 150 CFU / M3 and a Particulate content of approximately 1,000 0.3 μm particles per foot3a approximately 50,000 0.3 μm particles per foot3, or approximately 600 0.5 μm particles per foot3a approximately 500,000 0.5 μm particles per foot3.

[00010] Another aspect of the present invention is a method for purifying air, which includes providing an air flow path through a housing for air flow in a downstream direction, filtering the air through oxidation pre-filtration and adsorption of VOC inside the housing, filter the air through UV filtration inside the housing, downstream of the oxidation pre-filtration and VOC adsorption and filter the air through final particulate filtration inside the housing, downstream of the UV filtration.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

[00011] The invention will be described together with the accompanying drawings in which the same reference numbers designate the same elements and in which:

[00012] Figure 1 is a top view of an air purifier according to the present invention.

[00013] Figure 2 is a side view of an air purifier according to the present invention.

[00014] Figure 3 is an internal view of the air purifier along the plane defined by section line A - A in Figure 1.

[00015] Figure 4 is an internal view of the air purifier along the plane defined by section line B - B of Figure 2.

DETAILED DESCRIPTION OF THE INVENTION

[00016] Referring now in detail to the various figures in the drawings in which the same reference numbers refer to equal parts, are shown in Figures 1 and 2 top and side views, respectively, of an air purifier 2 according to the present invention. As illustrated, the air purifier 2 includes a substantially rectangular cuboid housing 4 which has an inlet 6 for receiving air and an outlet 8 for discharging air. The term "air" as used widely here refers to a gas or gas mixture that can be safely breathed in and / or that can serve as a source gas or gas mixture in the direction of an IVF laboratory. Housing 4 provides an airflow path for airflow in a downstream direction, that is, from inlet 6 to outlet 8. The term "accommodation" as used herein refers to any duct, chamber and / or casing, or a plurality of ducts, chambers and / or casings coupled to each other, providing an air flow path between them. Thus "housing" could include, for example, a set of ducts from an existing heating, ventilation and air conditioning ("HVAC") system or air ventilation unit ("AHU").

[00017] Although housing 4 is preferably substantially rectangular cuboid, as shown in Figures 1 and 2, it need not be limited to any specific shape. Furthermore, it can include internal curves, folds and / or other contours, whereby the air flow path would accompany such curves, folds and / or other contours. Preferably, however, the air flow path is substantially straight, as this is in the embodiment of housing 4 shown in Figures 1 and 2.

[00018] Air purifier 2 is preferably adapted to be installed in an existing HVAC or AHU system. In an alternative embodiment, an air purifier according to the present invention can function as an independent unit, that is, one that is not part of an HVAC or AHU system. An exemplary housing 4 can be a substantially rectangular cuboid that is approximately 3.3 m (11 feet) long by 1.2 m (4 feet) wide by 0.6 m (2 feet) high. Such dimensions would diffuse or spread the air through an air purifier 2 in order to provide sufficient resonance time for the air through each of the filtration media discussed below. A person skilled in the art understands, however, that the exemplary shape and size parameters above are merely illustrative, and can be changed, even substantially, depending on the circumstances or the application. For example, in some applications air purifier 2 may be approximately 1.8 m (6 feet) long.

[00019] Referring now to Figure 3, an internal view of the air purifier 2 is shown along the plane defined by section line A - A of Figure 1. In Figure 4, an internal view of the air purifier 2 is shown. along the plane defined by section line B - B in Figure 2.

[00020] To obtain optimum air quality, for example, suitable for an IVF laboratory, the air that is treated by the air purifier 2 must be preconditioned and stable, that is, moderate in terms of both temperature and humidity. moisture. Ideally, the air that is treated by air purifier 2 should have a temperature between approximately 20 ° C and 23.8 ° C (68 ° F and 75 ° F), and a humidity between approximately 45% and 55%. In addition, the air flow rate through air purifier 2 should preferably be approximately 1.25 m / s (250 ft. / Min) and below 2000 CFM. This preferential flow rate is designed to provide sufficient resonance time for the air through each of the filtration media discussed below. The term "filtration", as used herein, broadly covers one or more devices that treat air, such as trapping, removing, deactivating and / or destroying air contaminants.

[00021] In order to provide an adequate air flow rate through the air purifier 2, it may be useful (although not always necessary) includes a booster fan 10 downstream of inlet 6. Booster fan 10 may be coupled to a control system (not shown) that measures the air flow rate and triggers the booster fan 10 as needed to maintain the desired air flow rate. In an alternative embodiment (not shown), a booster fan may not be included, and the proper airflow rate may be provided and maintained by other means, for example, a blower in an HVAC or AHU system within which the air purifier 2 is installed.

[00022] Downstream of entrance 6 is the pre-filtration of particulate 12 for the trapping of airborne particulates. The particulate pre-filtration 12 is preferably approximately 50.8 mm (2 inches) thick in one embodiment, and includes left and right pleated particulate pre-filters 14,16. The particulate pre-filters 14,16 trap the raw particulates (e.g., dust and insects) from the outside air before this air reaches the other filtration media in the air purifier 2 discussed below. Filters suitable for particulate pre-filtration 12 are those that have a Minimum Efficiency Report Value ("MERV") of 5 to 13 with an Average ASHRAE Dust Point Efficiency (Standard 52.1) of 20% to 80%. Particularly preferred filters for particulate pre-filtration 12 are pleated filters that have a MERV of 7 to 8, with an Average ASHRAE Dust Point Efficiency (Standard 52.1) of 30% to 45%.

[00023] The selection of an appropriate pre-filter should be guided by the need to trap raw particulates without unduly affecting the rate of air flow through the air purifier 2. The specific type of particulate pre-filter (s) selected ( s) for particulate pre-filtration depends on several factors, including the quality of external air. It is preferred that the particulate prefiltration 12 is located immediately upstream of the additional filtration medium discussed below, as shown in Figures 3 and 4. Alternatively (or, in addition), however, the particulate prefiltration may be additionally located upstream, for example, in a set of ducts upstream of an HVAC or AHU system within which the air purifier 2 is installed.

[00024] Downstream of the pre-filtration of particulate 12 is pre-filtration of organic compounds ("VOC") 18. Once the air passes through the pre-filtration of particulate 12, the air is effectively free of raw particulates that otherwise they would decrease the efficiency and useful life of VOC prefiltration 18. VOC prefiltration ideally includes an adsorption medium, such as carbon, as well as an oxidation medium, such as potassium permanganate (" KMnO4 ") or a photocatalytic oxidant. A specifically preferred type of carbon is the virgin coconut shell. In a preferred embodiment, VOC 18 pre-filtration is a mixture of carbon and KMnO4, for example, in a 50/50 ratio. In some embodiments, the mixture may include additional elements, such as zeolite. The mixing ratio may vary depending on the types and levels of VOCs present in the source air. Ideally, the source air would be tested for VOCs, and, based on the test results, a customized mixture would be prepared to maximize VOC removal in a given environment. In an alternative form of VOC pre-filtration (not shown), separate (ie, unmixed) carbon and KMnO4 filters are used.

[00025] The VOC pre-filtration mode 18 shown in Figures 3 and 4 includes a total of twenty stacked filter trays 20,22, whereby ten such trays 20 are on the left side of the housing 4 and ten such trays 22 are directly adjacent, on the right. The length of the trays, that is, the longitudinal distance over which the air flows, is preferably approximately 431.8 mm (17 inches) in one embodiment, although it may be shorter or longer. Each tray 20,22 includes two mixed filters 24 of carbon and KMnO4, arranged in a V-shaped seat along a vertical plane (for example, the plane of Figure 3). The V-seat arrangement increases the surface area of the filters 24 over which the air must travel, thereby improving the efficiency of VOC 18 pre-filtration. Since air passes through VOC 18 pre-filtration. , the VOC load of the air is effectively reduced.

[00026] Downstream of the pre-filtration of VOC 18 is the post-filtration of particulate 26 for the trapping of airborne particulates, for example, the particles generated by the pre-filtration of VOC 18 (such as carbon dust). The particulate post-filtration 26 includes pleated left and right particulate post-filters 28,30. The filters used in the post-filtration of particulate 26 may be identical or similar to those used in the pre-filtration of particulate 12, discussed above. Although the post-filtration of particulate 26 downstream of the pre-filtration of VOC 18 is preferred, it may not be necessary in all applications. For example, if VOC pre-filtration is of a type that does not generate airborne particulates, such as bonded carbon, particulate post-filtration may be optional.

[00027] Downstream of particulate post-filtration 26 is ultraviolet ("UV") filtration 32 which destroys airborne biological contaminants and, in some modalities, degrades chemical contaminants. Whether or not particulate post-filtration 26 is used, the air that achieves UV 32 filtration must effectively be free of raw particulates and contain dramatically reduced VOC levels so as not to decrease the effectiveness of UV 32 filtration.

[00028] UV filtration can include one or more UV sources, although a plurality of UV sources is preferred. It is further preferred that these UV sources are UVC sources, capable of generating UV radiation at a wavelength ranging from 220 nm to 288 nm. More preferably, UVC sources are capable of generating UV radiation at a wavelength of 260 nm, however commercially available UVC sources capable of generating UV radiation at a wavelength of 254 nm are suitable. In an alternative embodiment described in US Patent No. 5,833,740 (Brais), which is incorporated herein by reference in its entirety, UV filtration includes at least one vacuum UV source, capable of generating UV radiation at a wavelength ranging from 170 nm to 220 nm (preferably 185 nm) and at least one UVC source, capable of generating UV radiation at a wavelength ranging from 220 nm to 288 nm (preferably 260 nm). In this embodiment, the UVC source is preferably downstream of the vacuum UV source. When operating, the vacuum UV source breaks the oxygen molecules into monoatomic oxygen which then reacts with the chemical contaminants in the air and then degrades them by successive oxidation to odorless and harmless by-products. The UVC source for biological contaminants in the air and degrades the residual ozone produced by the vacuum UV source into molecular oxygen.

[00029] The specifically preferred UV 32 filtration shown in Figures 3 and 4 is the "UV Bio-wall" made by Sanuvox. Alternatively, "Bio 30GX," which is also made by Sanuvox, is a preferred type of UV filtration. UV filtration 32 includes a pair of supports 34, 36 each of which has five UV lamps 38 (not all five of which are visible in the figures). The UV lamps 38 are preferably approximately 1524 mm (60 inches) in length and extend longitudinally through the housing 4 in order to maximize the time of exposure of the air to UV radiation. In one embodiment, UV lamps are sources of UVCs, which provide UV radiation within the UVC wavelength parameters discussed above. In an alternative embodiment, described in U.S. Patent No. 5,833,740 (Brais), each lamp 38 is double-zone, having a vacuum UV source upstream and a UVC source downstream. In an alternative embodiment, the upstream vacuum UV source can be, for example, a high intensity mercury vapor lamp capable of generating UV radiation that has a wavelength in the range of approximately 170 nm to approximately 220 nm, and the downstream UVC source can, for example, be a low intensity mercury vapor lamp capable of generating radiation that has a wavelength in the range of approximately 220 nm to approximately 288 nm. The interior 44 of housing 4 which involves UV filtration 32 is highly reflective, with a preferable reflection coefficient of at least 60%, in order to improve the efficiency of the lamps 38.

[00030] The rate of death from biological contaminants is a function of the intensity of UVC radiation produced by UV filtration 32 and reflected by the interior 44 of housing 4, as well as the exposure time of such contaminants from UVC radiation. Thus, the higher the intensity of UVC radiation and the longer the exposure time of such contaminants to UVC radiation, the greater the level of sterilization obtained. Depending on factors such as the level of sterilization desired, the amount of space available to host the UV filtration, and the costs of operating and maintaining the UV filtration, the desired total UVC output of the UV 32 filtration may vary. In a real mode, it was found that a total UVC output ranging from approximately 33,464 μJ / cm2a to approximately 90,165 μJ / cm2, with an average total UVC output of approximately 43.771 μJ / cm2, provided a desired level of sterilization, given the practical cost and space restrictions. Such an output of total UVC killed 100% of numerous biological contaminants including, but not limited to smallpox, influenza, tuberculosis, anthrax and H1N1 virus.

[00031] UV filtration 32 contained within housing 4 is probably not visible to a user of air purifier 2 when in use, because exposure to direct UV is harmful to humans. Thus, a user cannot visually assess (that is, simply by looking at the air purifier 2 itself) whether the lamps 38 are operating at a given time. It cannot be assumed that air purifier 2 is effectively destroying airborne biological and chemical contaminants, without being sure that UV filtration is operating properly. Consequently, it is preferred that the present invention includes sensors and a monitor (not shown) to detect and indicate, respectively, how long each UV lamp 38 has been in use and whether each lamp 38 has been operating at a given time. The monitor may include, for example, a rolling digital clock, which indicates the length of time that each lamp 38 has been operating. These sensors and monitor would indicate to a user when it is time to replace any of the 38 lamps.

[00032] As a general problem, the unit within housing 4 can encourage the growth of biological contaminants. Consequently, it is preferable to include a UVC source in the vicinity of areas where moisture is generated or accumulated. For example, upstream of particulate pre-filtration 12 there may be one or more cooling coils (not shown) which help to ensure that the air which is treated by the air purifier 2 is moderated in terms of temperature. Such cooling coils tend to generate moisture. It is therefore preferable to include a source of UVC adjacent to such cooling coils. Similarly, it may be appropriate to include a UVC source immediately upstream of a filter / diffuser (not shown) from which air enters a substantially closed space, for example, an IVF laboratory or other room, after leaving the air purifier. two.

[00033] Downstream of UV 32 filtration is VOC 46 post-filtration, which captures, for example, the VOC by-products of UV 32 filtration irradiation. Possible modalities of VOC 46 post-filtration include any of those above discussed concerning VOC pre-filtration 18. The VOC 46 post-filtration shown in Figures 3 and 4 includes VOC post-filters 48, 50 left and right 48, 50 that are arranged on a V-shaped bench over a horizontal plane (for example, the plane in Figure 4). VOC 48.50 post-filters, like their upstream counterparts, are preferably carbon and mixed KMnO4. Although VOC 46 post-filtration is preferred, in some applications it may not be required and can therefore be omitted.

[00034] Gametes and the human embryo are highly sensitive to VOCs, even in amounts considered insignificant in other applications. It is therefore essential that VOC filtration (both pre-filtration 18 and post-filtration 46) operate effectively to remove VOCs from the air that is fed in an environment in which IVF is being conducted. Consequently, one or more sensors to detect VOC levels (not shown), preferably in real time, can be placed in an IVF laboratory and attached to a monitor (not shown) to indicate VOC levels in the laboratory in a laboratory. given time. With such VOC detection in the room, a user of air purifier 2 would know how much time it is time to replace VOC pre-filtration 18 and post-filtration 46, and / or whether an alternative type or mixture of VOC filters would be most appropriate. Although VOC detection in the room is specifically useful in an IVF laboratory, it can be of help in any environment that requires low VOC levels.

[00035] Downstream of VOC 46 post-filtration is the final particulate filtration 52, which substantially traps all remaining particulates in the air before the air leaves the outlet 8. The final particulate filtration 52 preferably includes one or more filters capable of trapping fine airborne particles, for example, filters having an MERV of 13 or greater with an average ASHRAE Dust Point Efficiency (Standard 52.1) of 80% or greater. Most preferably, such filters have a MERV of 16 or greater with an average ASHRAE Dust Point Efficiency (Standard 52.1) of 95% or greater. Most preferably, such filters having an MERV of 17 or greater with an average ASHRAE Dust Point Efficiency (Standard 52.1) of 99.97% as high efficiency particulate air filters ("HEPA") do. Alternatively, ultra low particulate air filters ("ULPA") may be suitable. The choice of filter (s) for final particulate filtration should be guided by the potentially competing needs to maintain an optimal air flow rate and effectively remove particulates from the air.

[00036] The final particulate filtration 52 of Figures 3 and 4 includes HEPA filters 54, 56 of 304.8 mm (12 inches) in thickness. Preferably, magnetic meters (not shown) are placed both upstream and downstream of HEPA filters 54, 56 to measure the pressure drop through these filters. The degree of pressure drop will assist in identifying the appropriate time within which to change HEPA 54, 56 filters or other filters used for final particulate filtration.

[00037] Downstream of the final particulate filtration 52, there is an atomizer humidifier 58. Humidifier 58 may or may not be necessary, depending on the needs of the installation in which the air purifier 2 is being used. However, if a humidifier 52 is required, it must be placed, downstream of the final particulate filtration 52 so that moisture does not adversely affect the performance of VOC 48, 50 post-filters, HEPA filters 54, 56, or other filters used for the filtration of final particulate. Humidified air can contain and support the growth of biological contaminants. Consequently, if a humidifier 58 is used, an additional UVC source (not shown) to destroy such contaminants must also be included. This additional UVC source must be downstream of humidifier 58, preferably at the last point in the duct set before entering a room served by purified air.

[00038] An air purifier according to the present invention, such as the one described in detail above, will produce, an air characterized by a very high purity, suitable for environments sensitive to air contaminants such as IVF laboratories or other medical environments, for example. That said, an air purifier according to the present invention is not limited to IVF or other medical applications. This can be adapted for use in any substantially enclosed environment, including, but not limited to, homes, residential buildings, commercial buildings, hotels, cars, buses, trains, planes, cruise ships, educational facilities, offices, and government buildings. The invention may also have applications in, for example, national security, defense, or airline industries. The desired air purity can vary depending on the application and the environment. An air purifier according to the present invention, such as the one described in detail above, can be adapted accordingly to achieve a desired level of purity. The sequence and type of filtration medium in an air purifier according to the present invention provides air characterized by a purity that was unattainable with the previous devices.

[00039] Consequently, another aspect of the present invention includes purified air, such as that obtainable using an air purifier as described herein. Ideally, such purified air would be characterized by a high level of purity as measured by three parameters: (a) "TVOC," that is, the total volatile organic compounds, measured in "ppb," or parts per billion; (b) "Biological," that is, biological contaminants, including spores, measured in "CFU / M3," or colony-forming units per cubic meter (c) "Particulate," that is, the number of particles per foot cubic that have, for example, nominal sizes of 0.3 μm or 0.5 μm.

[00040] TVOC measurements can be made, for example, using GRAY WOLF SENSING SOLUTIONS, Model No. TG-502 Toxic Gas Probe with Photoionization Detector ("PID") sensors using a 10.6 eV lamp calibrated for Isobutylene . The lowest detectable limit for TVOCs using the TG-502 Toxic Gas Probe is 5 ppb.

[00041] To ensure accuracy, Biological measurements are preferably evaluated using two complementary methods. According to the first method of measuring Biologicals, ambient air (that is, the air being tested) is sucked into ALLERGENCO D spore traps using a high volume vacuum pump calibrated to suck 15 liters of air per minute . This is done for 10 minutes, so that a total of 150 liters of air is sucked through the spore trap cassette. The traps are then examined by microscopic observation of direct light to determine the identification of some selected types of biological contaminants present in terms of CFU / M3. According to a second method of measuring Biologicals, an ANDERSON N6 sampler is used to obtain culturable air samples (from the ambient air being tested) over three types of media: malt extract agar, cellulose agar and DG- 18. The sampler is calibrated pre- and post-collection to aspirate at a rate of 28.3 liters per minute for a sample time of 5 minutes. Using this second method to measure Biologicals allows the determination of the unique identification of any biological contaminant present in terms of CFU / M3 due to the three different types of growth medium.

[00042] Particulate measurements can be made, for example, using a TSI AEROTRAK 9306 Handheld Particle Counter. The particle counter is preferably calibrated with NIST-traceable PSL beads using a TSI Condensing Particle Classifier and Counters, the recognized standard for particle measurements. Particle concentrations in air are measured in nominal particle sizes of 0.3 μm, 0.5 μm, 1.0 μm, 3.0 μm, 5.0 μm, and 10.0 μm, per cubic foot (foot3 ).

[00043] In a preferred embodiment, it is contemplated that the purified air obtainable using an air purifier as described herein, is characterized by: (a) a TVOC content of less than 5 ppb (or below detectable limits using GRAY WOLF SENSING SOLUTIONS, Model No. TG-502 Toxic Gas Probe with PID sensors described above, or another instrument with similar measurement tolerance capabilities); (b) a Biological content less than 1 CFU / M3 (or below detectable limits using the Biological measurement methods described above, or other methods with similar measurement tolerance capabilities); and (c) a particulate content of approximately 1,000 0.3 μm particles per foot3 of air or approximately 10,500 0.3 μm particles per foot3 of air, or approximately 600 0.5 μm particles per foot3 of air at approximately 1,000 0.5 μm particles per foot3 of air.

[00044] Depending on the application or environment, acceptable levels of TVOCs, Biologicals and particulates may vary. For example, in one embodiment, the purified air is characterized by: (a) a TVOC content of less than 5 ppb to approximately 500 ppb; (b) a Biological content of less than 1 CFU / M3 to 150 CFU / M3; and (c) a particulate content of approximately 1,000 0.3 μm particles per foot3 of air to approximately 50,000 0.3 μm particles per foot3 of air, or of approximately 600 0.5 μm particles per foot3 of air to approximately 500,000 0.5 μm particles per foot3 of air. Most preferably the particulate content is approximately 1,000 0.3 μm particles per foot3 of air to approximately 30,000 0.3 μm particles per foot3 of air, or approximately 600 0.5 μm particles per foot of air to approximately 10,000 0.5 μm particles per foot3 of air. A specifically preferred particulate content is approximately 1,000 0.3 μm particles per foot3 of air to approximately 10,500 0.3 μm particles per foot3 of air, or approximately 600 0.5 μm particles per foot3 of air to approximately 1,000 0.5 μm particles per foot3 of air.

[00045] Another aspect of the invention includes providing purified air to an IVF laboratory to improve clinical pregnancy rates and / or IVF implantation rates. The clinical pregnancy rate refers to the presence of a fetal heartbeat inside an intrauterine sac. The implantation rate refers to the ability of a single embryo to implant into the uterus and develop a fetal heartbeat. A method of the present invention may comprise purified air, such as air as characterized above for an IVF laboratory, perform multiple cycles of IVF in the laboratory, and achieve a clinical pregnancy rate equal to or greater than 50% and / or an implantation rate equal to or greater than 35% based on a minimum patient population of 20 patients. In one embodiment, it is contemplated that the attainable clinical pregnancy rates would be 50% to 70% and more preferably 60% to 70%. In another modality, it is contemplated that the attainable implantation rates would be 35% to 40%.

[00046] Various aspects of the invention will be illustrated in more detail with reference to the following Examples, but it should be understood that the present invention should not be considered to be limited to these.

EXAMPLES

[00047] Before the air purifier described here, the national average for clinical pregnancy rates was approximately 38%. Couples often needed to complete multiple IVF cycles to conceive because total success rates were relatively low. As discussed above, the cost of a single IVF cycle is high and multiple cycles are prohibitive for many. Consequently, there was a strong and felt need - essentially since the advent of IVF approximately 30 years ago - to significantly improve IVF clinical pregnancy rates in order to make IVF a more viable option for infertility patients.

[00048] Prior to the invention of the air purifier described here, the inventor found that IVF laboratory air quality was not conducive to the successful growth of an embryo, even if existing filtration systems were used. The existing air filtration systems did not provide the air quality necessary to support the human embryo and this did not significantly improve the clinical results of IVF. In addition, existing filtration systems did not protect the IVF laboratory against varying concentrations of airborne contaminants from outside the source air. For example, if a nearby road or roof was being sprayed, the toxic products released would potentially enter the IVF source and laboratory air and thus impact developing embryos.

[00049] Below are examples of how the air purifier described here provides significant improvements in the technique, representing surprising and unexpected results and satisfying a need that has long been felt and unfulfilled. The examples compare the air purifier described here with the existing air filtration systems, including the Coda® System and the Zandair System. The Coda® System and Zandair System have been the primary air filtration systems used in IVF laboratories for at least the past ten years.

EXAMPLE 1

[00050] An air purifier modality has been installed in a beta IVF beta laboratory site. Before this installation, the laboratory used two Coda® Systems. Each Coda® System included, from an upstream to a downstream direction: (1) particulate filtration; (2) filtration of carbon and KMnO4; and (3) HEPA filtration. Before the installation of the aforementioned modification of the air purifier, the clinical pregnancy rates in the laboratory were 36.4%, which is close to the national average of approximately 38%. The air purifier modality described here that was installed in the laboratory included, from an upstream to a downstream direction: (1) particulate filtration (located upstream of the air handler unit); (2) filtration of carbon and KMnO4; (3) UV filtration; (4) filtration of carbon and KMnO4; and (5) HEPA filtration. After installing the aforementioned air purifier modality, clinical pregnancy rates in the laboratory jumped to 67.4% based on a patient population of 191 patients - representing significant and surprising results in clinical outcomes and patient care.

[00051] The "before" and "after" IVF implementation rates in the laboratory were measured. Before the installation of the aforementioned air purifier, the implantation rate in the laboratory was 21% and the national average was 26.1%. After the installation of the aforementioned modification of the air purifier, the implantation rate of the IVF laboratory beta site increased to 39% based on a patient population of 191 patients - representing significant and surprising results in clinical outcomes and patient care. The significant and surprising increase in implantation rates allowed the program in the laboratory to return fewer embryos per patient thereby reducing the chance of multiple pregnancies (eg, twins, triplets, etc.) and improving the total obstetric outcome.

[00052] In summary, these significant improvements in both clinical pregnancy rates and implantation rates demonstrate that the aforementioned modality of the air purifier described here has achieved unexpected results in relation to the closest prior art and has met a long-felt and unmet need answered.

EXAMPLE 2

[00053] The following three tables provide test data from independent third parties for air quality in an IVF laboratory. Common to all three tables is the following terminology: (1) "Source Air" - the air that enters an IVF laboratory before entering a respective filtration system; (2) "IVF laboratory" - the ambient air within the IVF laboratory; (3) "TVOC" - total volatile organic compounds, measured in "ppb," or parts per billion; (4) "Biological" - biological contaminants, including spores measured in "CFU / M3," or colony-forming units per cubic meter; and (5) "Particulate" - the number of particles per cubic foot that have nominal sizes of 0.3 μm and 0.5 μm. These measurements were made using the measurement devices and techniques described above.

[00054] TABLE NUMBER 1

[00055] IVF Laboratory

[00056] Using Two (2) Filtration Air Systems

[00057] Table Number 1 compares source air quality versus IVF laboratory air quality where IVF laboratory air has been subjected to two Coda® Systems, as described in Example 1 above. As Table Number 1 shows, the IVF laboratory actually had higher levels of TVOC and biological contaminants (including spores) than it had source air. Only the particulate levels fell between the source air and the IVF laboratory air.

[00058] TABLE NUMBER 2

[00059] IVF Laboratory

[00060] Using Three (3) Zandair Filtration Systems

[00061] Table Number 2 compares source air quality versus IVF laboratory air quality where IVF laboratory air has been subjected to three Zandair Systems. Each Zandair System included, from an upstream to a downstream direction: (1) carbon filtration; (2) HEPA filtration; and (3) photocatalytic oxidation together with UV filtration. As Table 2 shows, the air inside the IVF laboratory actually had higher levels of TVOC and biological contaminants (including spores) than did the source air. Only the particulate levels fell between the source air and the IVF laboratory.

[00062] TABLE NUMBER 3

[00063] IVF Laboratory Using a Single (1) Applicant's Air Purifier Mode Described Here

[00064] Table Number 3 compares source air quality versus IVF laboratory air quality where IVF laboratory air has been subjected to only a single modification of the air purifier described here. The aforementioned modification of the air purifier included, from an upstream to downstream direction: (1) particulate filtration (located upstream in the air handling unit; (2) carbon filtration / KMnO4; (3) UV filtration; (4) carbon filtration / KMnO4, and (5) HEPA filtration, as shown in table 3, in contrast to the air quality results of the two Coda® Systems and the three Zandair Systems provided in tables numbers 1 and 2 respectively, the only aforementioned modality of the air purifier significantly improved the air quality with respect to all three measured end points, that is, (1) TVOC; (2) Biological; and (3) Particulate.

[00065] The Coda® System and the Zandair System have been the primary air filtration systems used in IVF laboratories for at least the past ten years. The results of independent third-party tests provided in Tables 1, 2 and 3 demonstrate that the air purifier described here provided markedly superior air purity compared to the primary air filtration systems used in IVF laboratories for at least the last few years. ten years. The superior air purity generated by the air purifier described here is surprising. Also surprising are the clinical pregnancy rates and significantly improved implantation rates described in Example 1 above, resulting from the superior air purity generated by the air purifier described herein.

[00066] Taken together, Examples 1 and 2 demonstrate that performing IVF in an ambient air that was purified at the levels described here for three parameters - TVOCs, Biological and Particulate - unexpectedly and significantly improved clinical pregnancy rates and implantation rates of IVF. In addition, given that the IVF has existed for approximately 30 years and that the Coda® System and the Zandair System have been the primary air filtration systems used in IVF laboratories for at least the past ten years, there was a long-felt need and not serviced for an air purifier optimized for, among other things, IVF applications. The air purifier described here has met this need.

EXAMPLE 3

[00067] An air purifier modality described here was installed in a beta IVF laboratory site. This modality included, from an upstream to a downstream direction: (1) particulate filtration (located upstream in the air handling unit; (2) carbon filtration / KMnO4; (3) UV filtration; (4) carbon filtration. / KMnO4; and (5) HEPA filtration.

[00068] A catastrophic charge of VOCs was accidentally introduced into the building that housed the IVF laboratory. Specifically, a contractor spilled a floor sealer over a large floor surface area in a room just adjacent to the IVF laboratory. The floor sealer comprised 10% xylene and 40% acetone. Both xylene and acetone are highly embryotoxic. While personnel outside the IVF laboratory developed severe nausea and headaches from the vapors, the aforementioned modification of the air purifier protected embryos and personnel within the IVF laboratory. TVOC tests before and during the accident showed that despite more than 6000 ppb of TVOCs immediately outside the laboratory - an extremely high level - VOC levels did not change within the laboratory.

[00069] In short, the significant and surprising results of the Applicant's air purifier, as demonstrated in Examples 1, 2 and 3, were surprising and unexpected for the inventor and would be surprising and unexpected for those skilled in the art. These examples also help to demonstrate how the Claimant's air purifier satisfied a long-felt and unmet need for an improved air purifier which allows for significantly improved clinical pregnancy rates and implantation rates.

[00070] Although the invention has been described in detail and with reference to its specific examples, it will be apparent to someone skilled in the art that various changes and modifications can be made to it without departing from its spirit and scope.

Claims (27)

1. Method of performing in vitro fertilization ("IVF"), the method comprising the steps of: - providing purified air, characterized by the fact that the purified air comprises: a. a TVOC content of less than about 5 ppb to about 500 ppb; B. a biological material content of less than about 1 CFU / M3 to 150 CFU / M3; and c. a particulate content of about 1,000 particles from 0.3 μm per foot3 of air to about 30,000 particles from 0.3 μm per foot3 of air, or about 600 particles of 0.5 μm per foot3 of air at about 10000 μm particles per foot3 of air, and - perform at least one in vitro fertilization procedure on the said purified air. Method according to claim 1, characterized in that the at least one IVF procedure comprises a plurality of IVF procedures. 3. Method according to claim 2, characterized by the fact that the plurality of IVF procedures results in a clinical pregnancy rate of at least 50%. 4. Method according to claim 2, characterized by the fact that the plurality of IVF procedures results in a clinical pregnancy rate of 50% to 70%. 5. Method according to claim 2, characterized by the fact that the plurality of IVF procedures results in a clinical pregnancy rate of 50% to 65%. 6. Method according to claim 2, characterized by the fact that the plurality of IVF procedures results in a clinical pregnancy rate of from 55% to 70%. 7. Method according to claim 2, characterized by the fact that the plurality of IVF procedures results in a clinical pregnancy rate of from 55% to 65%. 8. Method for obtaining an IVF clinical pregnancy rate of at least 50%, characterized by comprising: running multiple cycles of IVF in purified air comprising: a. a TVOC content of less than about 5 ppb; B. a biological material content of less than about 1 CFU / M3; and c. a particulate content of about 1,000 particles of 0.3 μm per foot3 about 10,500 particles of 0.3 μm per foot3, or of about 600 particles of 0.5 μm per foot3a approximately 1,000 particles of 0.5 μm per foot3, in order to obtain an IVF clinical pregnancy rate of at least 50%. 9. Method according to claim 8, characterized by the fact that the clinical pregnancy rate of IVF is 50% to 70%. 10. Method according to claim 8, characterized by the fact that the clinical pregnancy rate of IVF is 50% to 65%. 11. Method according to claim 8, characterized by the fact that the clinical pregnancy rate of IVF is 55% to 70%. 12. Method according to claim 8, characterized by the fact that the clinical IVF pregnancy rate is 55% to 65%. 13. Method for purifying air, comprising the steps of: a. provide purified air (2); B. purify the air with the purified air (2), in order to provide purified air, characterized by the fact that the purified air comprises: c. a TVOC content of less than about 5 ppb; d. a biological material content of less than about 1 CFU / M3; and is. a particulate content of about 1,000 particles from 0.3 μm per foot3 of air to about 10,500 particles of 0.3 μm per foot3 of air, or about 600 particles of 0.5 μm per foot3 of air at about 1,000 μm particles per foot3 of air. 14. Method according to claim 13, characterized in that the air purifier (2) comprises: a. a housing (4) that has an inlet (6) for receiving air and an outlet (8) for exhausting the air, the housing (4) providing an air flow path for air flow in a downstream direction, from the entrance (6) towards the exit (8); B. oxidizing and adsorbent VOC pre-filtration (18) inside the housing (4) downstream of the inlet (6); ç. UV filtration (32) inside the housing (4) downstream of the VOC pre-filtration (18); and d. filtration of final particulate (52) inside the housing (4) downstream of the UV filtration (32). 15. Method for purifying air, characterized by comprising the steps of: a. providing an air flow path through a housing (4) for air flow in a downstream direction; B. filter the air through oxidation pre-filtration and VOC adsorption (18) inside the housing (4); ç. filter the air through UV filtration (32) inside the housing (4), downstream of the oxidation pre-filtration and VOC adsorption (18); and d. filter the air through final particulate filtration (52) inside the housing (4), downstream of the UV filtration (32). Method according to claim 13, characterized in that it further comprises the step of filtering the air through pre-filtration of particulate (12) inside the housing (4), upstream of the pre-filtration of VOC (18). 17. Method according to claim 15, characterized in that the pre-filtration of VOC (18) comprises bonded carbon. 18. Method according to claim 15, characterized in that it further comprises the step of filtering the air through VOC post-filtration and oxidation and adsorption (46) inside the housing (4), downstream of the UV filtration (32) and upstream of the final particulate filtration (52). 19. Method according to claim 15, characterized by the fact that VOC pre-filtration (18) and VOC post-filtration (46) comprise bonded media. 20. Method according to claim 15, characterized in that the pre-filtration of VOC (18) comprises one or more filters (24) that contain bound carbon and KMnO4. 21. Method according to claim 15, characterized in that it further comprises the steps of filtering the air through pre-filtration of particulate (12) inside the housing (4), upstream of the pre-filtration of VOC (18) and filtering the air through VOC post-filtration and oxidation and adsorption within the housing (4), downstream of the UV filtration (32) and upstream of the final particulate filtration (52). 22. Method according to claim 15, characterized by the fact that VOC pre-filtration (18) and VOC post-filtration (46) comprise one or more filters (48, 50) that contain bound carbon and KMnO4 . 23. Method according to claim 15, characterized in that the final filtration of particulate (52) includes one or more filters (54, 56) selected from the group consisting of HEPA filters and ULPA filters. 24. Method according to claim 13, characterized in that the air purifier comprises: a. a housing (4) that has an inlet (6) for receiving air and an outlet (8) for exhausting the air, the housing (4) providing an air flow path for air flow in a downstream direction, from the entrance (6) towards the exit (8); B. UV filtration (32) inside the housing (4) downstream of the inlet (6); ç. oxidation and adsorption VOC post-filtration (46) within the housing (4) downstream of the UV filtration (32); and d. final filtration of particulates (52) inside the housing (4) downstream of the VOC post-filtration (46). 25. Method according to claim 24, characterized in that the air purifier (4) comprises a booster fan (10) inside the housing (4), downstream from the inlet (6) and upstream from the filtration UV (32). 26. Method according to claim 24, characterized in that the final filtration of particulate (52) includes one or more filters (54, 56) selected from the group consisting of HEPA filters and ULPA filters. 27. Method according to claim 13, characterized in that the air purifier (2) comprises a housing (4) that has an inlet (6) for receiving air and an outlet (8) for exhausting air, the housing (4) provides an air flow for the air flow in a downstream direction, from the inlet (6) in the direction of the outlet (8), where the following are provided in the housing: VOC filtration (18, 46 ), UV filtration (32) and HEPA or ULPA filtration (54, 56).

Images