WO2007125376A1 - The hygienic infection free therapeutic mattress - Google Patents

Abstract

Hospital care acquired infections (HCAI) is the main problem addressed by the invention. Relating to hospital aftercare services field reference is also made to latex foam and polyurethane film manufacturing fields. Secondary infection during hospital aftercare is a common occurrence and is propelled by contaminated mattresses on hospital beds. Conventional mattresses are vulnerable to contamination due to absorption. They are often overlooked owing to time consuming cleaning requirements. Capitalizing on this issue the Hygienic Infection free Therapeutic mattress was developed which constitutes a natural latex based mattress (FIG.1) covered by a specially developed polyurethane lamination film (FIG.6). The lamination prevents contamination and effects easy cleaning. The natural latex together with special therapeutic ingredients effects comfort, eliminate bedsores and accelerates the recovery process. The self adhesive lamination eliminates seams, threading and edges with no contaminable areas. Application of this mattress helps any aftercare facility to enhance patient turnaround with ease.

Description

THE HYGIENIC INFECTION FREE THERAPEUTIC MATTRESS

The hygienic, infection free therapeutic mattress is a product developed with a two pronged objective. On one hand it is designed to extend absolute comfort and hygiene for the users and on the other for absolute ease of maintenance. Emphasis is made however to the absolute comfort and absolute hygiene features as it is our main proposition to the market. The incorporation of these objectives into one product forms the basis for the invention and a life saving cost effective product for addressing the growing concerns of the caring industry.

Technical field Reference is warranted to a combination of technical fields for the proper assessment of the invention. These would be the latex foam manufacturing field, poly urethane film manufacturing field and hospital care and infectious disease aspect of the medical field.

Background art

The thought process to develop this product was greatly influenced by exposure to the after care aspect of the hospital services industry. The hospital services industry in it's self is quite vast and complex and the comprehension of same in its entirety is not warranted here. However though, much emphasis is placed on the after care aspect of the hospital services industry which is mandatory in assessing the applicability of the invention. During the remainder of the discussion any reference to industry or sector would ideally mean the after care aspect of the hospital services industry unless otherwise stated.

Hospital aftercare services have been and are being increasingly focused upon by hospital administrators for faster patient turn around, focusing of course on the obvious competitive, profitability and cost reduction angles. The cost mechanism is directly influenced by patient turn around and patient turnaround is directly proportional to the rate of recovery of patients. Unlike any other industry the equation of patient to customer give rise to a sensitive operating environment where customer satisfaction becomes quick recovery from illness and recovery on the other hand is considered in both the emotional and physical contexts which are interrelated. Whilst a certain part of the emotional aspect is handled by the staff (doctors, nurses etc) the physical aspects with its significant influence on comfort directly relates to the reduction of agonizing experiences to patients and thereby contributes to the emotional well being and faster recovery of patient. As such the physical aspect commands prime attention in the event of any improvement to the service or when faster patient turn around is expected. These physical aspects in question would of course be the equipment provided for after care purposes and amongst them what matters most to the equation are the objects that are frequently and personally in contact with the patient.

Yet another perspective to this administrative focus on after care is the concern on after care infections. After care infections are costing hospitals millions of dollars, by way of law suits with the worst case scenario leading to irrecoverable loss of life upon instances where such infections reach acute stages. The issue is generally classified as Hospital Care Acquired Infections (HCAI) and will be further dealt with during the remainder of this discussion.

As seen from above it is but evident that there exists great opportunity and need for solutions to address significant problems of the sector and to further the hospital after care services. However in the approach towards the provision of such solutions further clinical focus is warranted on the specific influencers to the issues of the sector. As such combined with our significant empirical exposure to the sector and along the lines of the earlier discussion we can logically relate to three specific criteria that would have great influence on enhancing services and addressing issues of the industry. They are namely, the provision of comfort for patient (customer) that helps speed up the recovery process, absolute hygiene to avoid after care infections and an effective sustenance mechanism (ease of maintenance) ensuring the previous two criteria are constantly maintained in the most cost effective manner. These three criteria now form the basis for the remainder of the discussion and will be dealt with individually in greater detail to assess and validate the applicability of the invention.

Provision of comfort

As we learnt earlier comfort plays a noticeable role in a patient's recovery process and that comfort is a product of quality physical resources supplied to the patient. Assessment of these resources of course is also complex considering all the physical aspects starting from the patient's room, bed, temperature, toilet facilities etc. There is however one component that clearly stands out in consideration of maximum contact with the patient. The item in concern is the bed and there upon the mattress on the bed as the core component. On an average it is quite logical to express that the patient spends at least 75% of his/her recovery time on the bed and where in some cases the figure quite rationally could reach up to the 100% mark. In the context of long bed ridden applications the comfort factor of the mattress is found to play a major role in the control of bed sores. Comfort generally associates with the hardness of the surface in this case the mattress and in the context of clinical studies on bedsores (pressure ulcers) it is more fully termed as interface pressure (IP) of the surface. Many studies are being carried out on the relationship of interface pressure (IP) to pressure ulcers (PU) and it has been found that IP is one main concern to be considered in the control of pressure ulcers (PU). Source the European Pressure Ulcer Advisory Panel (epuap). Considering the above points we can arrive at the conclusion that the provision of comfort to a patient is important and in doing so it is inevitable that the mattress of the hospital bed receive primary attention. This fact brings us towards the consideration of one sub inventive step related to the main invention characterizing one of the final product's features of providing absolute comfort.

Provision of hygiene The reflection here is to create an environment hostile to various contagious micro organisms. It can be further elaborated with the term absolute cleanliness which is responsible for developing such an environment.

In the industry, the term Hospital Care Acquired Infection (HCAI) has significant focus and is a major concern. This concern is present in almost every hospital globally and is focused upon on a daily basis. HCAI is a product directly proportional to the levels of cleanliness of a hospital and is especially associated with after care services. In brief HCAI is the term identified to reflect infections or illnesses that are caused by merely being in a hospital for reasons totally unrelated to such illnesses. As far back as 1990 reports have reflected patients being infected by various bugs during hospital care. Patients with wounds or after surgery are especially vulnerable since it creates an easy means for bacteria to enter and propagate and also it is a time that the immune systems are generally at very low levels. This is the very reason that such infections are generally visible in and around hospital premises warranting much clinical attention. It has been found that bacteria such as MRSA, Pseudomonas Aeruginosa, Ceratia Marusessence, Hepatitis, TB 95 etc are generally associated with most of the infections. Amongst these of course the MRSA bug is now feared the most dangerous of them all. It is a bug known as Staphylococcus aureus or Staph for short. This bug (bacteria) generally is responsible for effecting skin diseases and is highly active in areas where the skin is disturbed with cuts or wounds etc. It also penetrates through wounds to blood and the bone creating bone

100 disintegration and even has the capability to cause pneumonia and finally causing fatalities. This bug is found to be highly resistive to antibiotics even to the powerful Methicillin a synthetic variant of Penicillin deriving its name Methicillin Resistant Staphylococuss Aureus (MRSA). Many fatalities during after care have been found to be caused by MRSA and is a fact continuing even as of now. Its seriousness is well

105 established and reflected through out many information sources including the internet which has immense amount of data. For the purposes of this discussion however much reference to information published by the CDC (centre for disease control) of the US and the HICC (hospital infection countermeasures committees) based at many hospitals and universities in Japan, were made.

110 In response to this grave problem hospital infection counter measures have been deployed through out the world and are being constantly improved to control after care infections. The teams from many parts of the world have conducted various tests to detect the propagation of these bacteria so that the results can effectively influence countermeasures to control the issue. One such interesting report was published from the Kitazato Research

115 Institute of Japan which had clearly pointed out that the most conducive place for any bacteria to propagate is the mattress on the hospital bed. It also revealed that from a test conducted amongst 10 hospitals in Japan, almost all beds in all the hospitals were infected with the staphylococcus bacteria. A freighting but a true fact now found to be common in many hospitals.

120 The above research had also pointed out that by general hygienic practice hospitals do subject items such as futon, bed pads /sheets, pillows, clothes, pillow covers etc for thorough cleaning but most often miss the point of cleaning the mattress. It is also quite difficult to clean conventional mattresses due to its absorption properties making them almost impossible to clean. The main identified issue is that, bacteria and its by-products

125 such as pus and humor penetrates deep into the mattress where there's an environment which is not visible to the outside world and never subjected to external cleaning measures. The penetration of human waste, sweat and blood also into the mattress creates an environment absolutely conducive for the propagation of micro organisms in this case bacteria. Hence no matter how much effort is applied on external cleanliness there is a

130 domain of infectious bacteria within the mattress which can recurrently infect all those who come in contact with it. This then brings us towards the consideration of yet another sub inventive step related to the main invention characterizing another feature of the final product, the provision of absolute hygiene.

Sustenance mechanism

135 Ease of maintenance contributes immensely in ensuring consistency in the provision of comfort and hygiene to the patient and hence the sustenance of the earlier two criteria. If the maintenance process is complex there is much possibility for lapses during execution of maintenance tasks. Also complex procedures are often related with high costs and hospital administrators would be under constant pressure to focus on profitability at the

140 expense of hygiene. In considering some of the related maintenance practices we can apply focus to hospital rooms where after care is normally administered for patients. For the purpose of this discussion we shall now limit the focus to the bed inside the hospital room. During the above discussion we identified few cleaning practices in and around the patient's bed and also found out that cleaning the mattress is most often overlooked

145 although it is now found to be a very significant issue. If we consider the cleaning of all other associated material (covers, pillows, sheets etc) we tend to wonder why the mattress is not on the list. The reason behind this of course is the very fact of cleaning a mattress is so complex and time consuming (from a washing perspective long hours on drying, large quantities of detergents etc) and would definitely be of high cost. Also since infectious

150 substances penetrate inside the mattress one could never assess complete cleanliness.

Hence from a business perspective this does not make sense at all. As such the situation opens up a great opportunity for alternative cost effective solutions. This then brings us towards the consideration of yet another sub inventive step related to the main invention characterizing the product's easy maintenance feature. 155 At this juncture due diligence is warranted to the macro business perspective and in that context it is the patient turnaround time that is the key to business success. Whilst the provision of comfort and absolute hygiene ensure speedy recovery the simplified maintenance minimizes idle time between patients resulting in faster patient turn around. The course of hospital infection(innai kansen no Yukue) published by Kawade from Japan

160 reflects that on average the patient turnaround in hospitals experiencing hospital infections is 17 days longer than that with hospitals that have had no reports on after care infections. The other business impact is the legal issues and law suits since the after care infections are clearly identified as within the responsibilities of the hospital. CDC had published a report as far back as 1993 stating that additional costs incurred by hospitals due to hospital

165 infections were US$ 2, 100 per patient.

Reflecting back at the three criteria of comfort, hygiene and ease of maintenance and identifying growing industry concerns on these lines it was clearly visible that a product which could simultaneously satisfy all these concerns could attain good demand in the market. Having also understood that the facts revolved around a hospital mattress it was

170 concluded that the solution lies in the form of an improvement to a mattress or a whole new design of a mattress. Being involved in the mattress manufacturing business for a considerable period of time and being timely and well informed of the industry to be addressed I firmly believed that the invention is well poised to provide the ultimate solution to the industry.

175 Disclosure

Summarizing all of the above and arriving at the problem(s) being addressed, as is customary, makes the easier assessment of the relevance of the invention. As such it could rightfully be reflected that the main problem being addressed here is hospital care acquired infections. With combined focus on provisioning comfort and the reduction in

180 maintenance efforts the solution is designed to drive the final objective of cost-effective efficient patient turnaround.

In revisiting the considerations of the sub-inventive steps and the criteria above we find that, provisioning of comfort to patients relates with the hospital mattress, the control of hospital care infections relates to the levels of contamination of the hospital mattress and

185 that major lapses in cleaning, due to complexity and additional effort also associates with the hospital mattress. As all these associates with the hospital mattress the -window of opportunity was thus capitalized and the inventive concept was derived to develop a unique hospital mattress that could give absolute comfort aiding therapy, resist any type of contamination even for bacteria and have a physical structure allowing cost-effective easy

190 maintenance. Thus the Hygienic, Infection free, Therapeutic mattress was born.

The product as a whole constitutes two parts, they are namely the Inner Core and the Lamination Film. The core of the entire mattress is made out of pure natural Latex (NR foam mattress). Please refer FIG.l. A special poly urethane film, which will be termed as the lamination film from now on, was then developed to be laid on the latex core and to

195 cover all sides of the core. The inner surface of the lamination film contains an adhesive layer for easy, even and seamless application. Please refer FIG.2. Once the lamination film was pasted to cover the entire core (o% exposure), the main product was completed. Please refer FIG.6. For further comprehension of derivation of features of the product, let us examine the two

200 main components, the inner core and the lamination film in greater detail.

The inner core

It has been researched and found that natural latex, or more fully known as Natural Rubber (NR) has very low interface pressure (IP) owing to its natural internal cell structure. This is sometimes expressed as having low internal cell pressure providing low IP. The low IP

205 also expresses the feature of even weight distribution since there are no high peak pressure areas obstructing the distribution of weight. This feature is easily identifiable through ergonomic test equipment specific to cushioning, where in this case the well known brand ErgoCheck was extensively used in testing the product. In the area of health this fact effect smoother and even blood circulation characterizing the remarkable feature of reducing

210 bedsores. Natural latex especially in the form of foam mattresses is also well known to take the body contour of a person mήiimizing or eliminating areas of non contact between the body and the mattress. This further aids ha the whole process of delivering comfort. Apart from above facts on provisioning comfort, Natural Rubber (NR) is also well known for it's properties of durability, elongation and compression providing product durability

215 and character maintenance over a considerable period of time. It is also found to burn more slowly and emit very less toxins during a fire unlike its synthetic alternatives. NR also is proven to be environment friendly due to its degradable properties affected by the presence of natural proteins. NR is also considered safe even to the extent of associating with food and is also a preferred choice when making toys for infants.

220 Applying due consideration to these facts the selection of a natural latex foam mattress as the inner core for the product was an obvious choice.

The lamination film

The comfort aspect and the resultant partial therapeutic features were established with the selection of the NR inner core. The next step was to apply the hygienic aspect to the

225 product and with it a structure that would facilitate lesser effort on maintenance.

Reference is made here to the discussion during the background art on hospital care acquired infection (HCAI). It was expressly reflected that the contamination of the inner mattress of hospital beds was the primary cause for infection propagation and that the complexity of cleaning the mattress often led to over sights on cleanliness practices.

230 A solution was thus warranted to prevent such contamination of the selected NR inner core and to contain any contamination to an area easily cleanable. The approach taken was to cover the inner core with a material non permeable to liquids, bacteria, etc. preventing most types of contamination. In the event of contamination the contaminants would remain on the surface of the covering material being fully exposed to external cleaning

235 measures. The covering material also had to have characteristics of durability, flexibility and the texture had to be in a manner that would not interfere with the qualities of comfort of the NR inner core. The covering material, having the primary exposure to cleaning measures and practices, also had to be resilient to such practices so that no damage occurred as a result.

240 Guided by these directives and subject to extensive research, tests and development a very thin but strong poly urethane film was developed as the most appropriate for the use as the covering material. This then derived the second component of the final product the lamination film. In general Urethane is known to contain the best properties of rubber and plastic without the inherent brittleness of plastic. The compounds contain various

245 properties, otherwise not found in other thermoplastics, which gives extensive design flexibility. Extremely thin films can be produced with commendable durability and tensile strength. Urethane also comes with the ability to elongate which would help to maintain flexibility of the mattress and also has significant abrasion resistance. One other significant character of Urethane, thus a significant influencer for consideration, was the 250 chemical and environmental resistance which extended to hydrocarbons, ozone, bacteria, fungus and moisture and even to skin oils. Polyurethane has been also found to be harmless in their applications and is being currently considered for medical applications even to the extent of usage on artificial hearts, blood vessels and stitching applications. All such features were immeasurable for our end product design which helped to address most 255 of the product feature needs. These features with further improvement through varying concentration and ratios of the Resins applied hi manufacturing the Polyurethane film brought about the specific and much needed characteristics for the end product. The lamination film was further developed and modified to make effect other special features that were of value to the end product. As such the following are the full list of features that 260 directly associates with the lamination film. a) Anti permeability - Enhancing on polyurethane' s inherent characteristics the lamination film provides water impermeability to the fullest and with the backing of it's significant air impermeability feature, no contamination what so ever is permitted through the material. This is extended even to micro organisms such as 265 bacteria and then: by-products i.e. pus and humor. To certify the fact the developed material was subjected to the water vapor permeability test under Japanese Industrial Standards JIS L 1099-1993 which returned very positive results. The anti permeability to air restricts oxidation of the inner core and as such the core and its inherent characteristics are protected for a considerable period of time.

270 b) Resilience to cleaning measures - It was found that hospitals use detergents such as

Alcohols (mostly), Iodine, Hibiten etc in their cleansing practices and all these and their variants have been identified to be effective against bacteria associated with HCAI issues. Another aspect found was the application of hot water, generally at temperatures close to 100°c, as measures of disinfection. The resin concentration of 275 the polyurethane covering material, namely the lamination film of the product, was thus modified to withstand such detergents and temperature. In effect tests further proved that the developed lamination film was capable of handling up to 140°c of hot water before disintegration took place. c) Surface friction - The selection of materials to develop the lamination film was two 280 fold. For the top and side surfaces materials were selected and developed to give high friction on the lamination film surface where the patient and covers did not slide down when the product was placed on foldable beds (gatch beds). For the bottom surface however materials were selected and developed to minimize friction on the lamination film surface. This way the product was easily slid both 285 on and off the bed. d) Self adhesive - Subsequent to extensive research the lamination film was developed with an adhesive layer on its inner surface for ease of application to the inner core. This fact further confirmed the status of absolute hygiene since there were no seams, threading or edges, otherwise found on conventional mattresses,

290 creating vulnerable areas for contamination. Further more the durability of the lamination film is further enhanced by the firm and complete pasting with no areas sagging and being subjected to unnecessary tension. e) Special self therapeutic effect - To enhance the therapeutic effects it was decided to further develop the lamination film to contain therapeutic material which can easily

295 emit therapeutic values to the patient. For this purpose two very special therapeutic materials (minerals) identified by two eminent scientists in Japan were used. The materials in concern have been extensively researched and tested and have been classified under the category of Naturally Occurring Radio Active Material, or NORMS as is commonly known. The application of finely powdered NORMS to

300 the lamination film thus created a special inventive step for generating therapeutic effects on a mattress. The NORMS selected for our specific purpose have the distinct values of de-odorant effect, antibacterial effect, infrared rays effect and hot spring effect. These values have been in use in Japan for therapeutic applications for a considerable period of time. Alternatively further research is underway to

305 develop this concept (the self therapeutic effect) of a mattress. Tests are being conducted on the application of Titanium Di-Oxide (Tiθ2) with its photo synthesis process effecting similar therapeutic characteristics as would the selected NORMS. So far TiO2 has been identified with good antibacterial and deodorizing effects when exposed to light and is freely available for application. 310 In summery we have arrived at the Hygienic Infection free Therapeutic Mattress having a natural latex foam mattress as its inner core and a specially developed laminated film acting as a lamination covering all its surfaces. The product is resilient to most cleaning methods at hospitals, its flexible and easy to handle. Its anti permeable capabilities have proven to withstand penetration of even micro organisms (especially bacteria) which acts

315 as the nucleolus of all features that aids the combat against HCAIs expressing its absolute hygienic features. This fact was further confirmed through the subjection of the product to an Anti Bacterial Effect and Anti Permeability of Pus /Humor testing process jointly conducted by Kitazato university, Iwate medical university and Morioka Yuai hospital all based in Japan. It was conducted under the guidelines of Examination on Laundry and

320 Hospital Infection Countermeasures efforts in Japan. The tests especially associated with the infusion of MRSA (along with other bacteria) on to the mattress and observing the behavior of the bacteria after cleaning with alcohol. The results were very positive since the observations reflected that all bacteria were dead within 30 seconds of detergent application and that there was no evidence of any penetration or contamination of the core.

325 The anti permeability effect was also further validated by subjecting the product to a water vapor permeability test under Japanese Industrial Standards namely JIS L 1099 where a fair assessment of both liquid and air permeability was obtained. Here the evaporation of water through the product was tested for a period of 24hrs. The results obtained were 0.48kg/m2/24 hrs where in the permeability scale it is considered to be very low. The self

330 therapeutic effects discussed under section e) above were also subjected to further testing. The specific testing was on the antibacterial characteristic of the therapeutic effects. The product was subjected to an Antibacterial Efficiency Test under the Japanese Industrial Standards namely, JIS Z 2801:2000 5.2 done at the Nippon food analysis centre. Here too the test was associated with the infusion of MRSA, however without any external

335 cleansing agents. The observation after 24hrs proved that the product has self antibacterial effects where the bacteria count had drastically reduced while in the conventional products(mattresses) the count had increased by 10-15 times. The efforts above, subjecting the developments to various tests, were based on the objective of challenging the concept and certifying its feasibility in the empirical context.

340 In this case the results were favorable and further validated the product's hygienic infection free therapeutic features. These values when complemented by significant comfort and ease of maintenance express the confidence of the invention being a major contributor to the hospital care /after care industry. It aids very comprehensively against the combat of HCAIs and the deadly MRSA propagation. In summery the invention, i.e. 345 the Hygienic Infection free Therapeutic mattress was designed to address many issues in the health care industry especially the ones associating with the aftercare applications. The following expresses the comprehensive array of benefits from the product,

Advantageous effects

The product's ease of handling especially supports the administrative efforts of hospitals 350 ensuring the fact of consistent higher levels of maintenance. Even the most deadliest bacteria could be simply wiped away with a cloth and a little detergent. Its durability, simplicity and cost effective maintenance encourages administrators to achieve higher levels of hygiene. As such achieving the satisfaction of the hospital adrninistrators and or hospitals services personnel ensures that the product can become an obvious choice in the 355 application of after care services. Attaining such application would then be the portal of opportunity to extend immeasurable values to patients or in the context of business, the customers. This winning combination of administrative ease and patient satisfaction encourages service level consistency and an almost autonomous cycle thus evolves towards the enhancement of after care practices. In the event of commendable aftercare 360 practices the patient turnaround would be greater enhancing both profitability to the organization and healthier lives to human beings. The following would be the comprehensive array of features and advantages of the final product, a) Absolute comfort (patient satisfaction) b) Elimination of bedsores (faster recovery) 365 c) Absolute hygiene (cleanliness) d) Easy to clean and maintain (cost effective and ensure consistency) e) Elimination of bedsores (faster recovery) f) Anti permeability to liquids preventing contamination (cleanliness) g) Anti permeability to air protecting the characteristics of the inner core (durability) 370 h) Antibacterial effect with restriction of bacteria to the surface (infection free) i) Self Antibacterial effect to compensate for lapses in hygienic measures (infection free) j) No stitches and edges (seamless) non conducive for contamination k) Self therapeutic effects (faster recovery) 375 1) Resilient to hot water up to 140°c (durability) m) Resilient to detergents (durability) n) Quicker patient turn around and higher profitability o) Reduced complaints and almost zero possibility for law suits

Description of drawings

380 FIG.l. Reflects the Natural Latex mattress which will be considered as the inner core of the product. 50 refers to the inner core and 55 refers to the pin holes normally found on Latex foam mattresses which effects the control of density.

FIG.2. Reflects the rolled and completed Lamination film before application, where 70 refers to the Lamination film, 75 refers to the outer paper based protective layer and 76

385 refers to the inner paper based protective layer which also protects the adhesive layer.

FIG.3. Reflects the application of the bottom Lamination to the inner core where, 50 refers the inner core and 70 refers to the Lamination film (bottom, frictionless). Note extra width and length of Lamination for side coverage. FIG.4. Reflects the partially completed product with the bottom Lamination layer securely

390 in place where, 50 refers to the inner core and 70 refers to the laminated part.

FIG.5. Reflects the application of the top Lamination to the partially completed inner core where, 50 refers to the inner core, 70 refers to the bottom laminated part and 71 refers to the top Lamination (friction type). Note excessive width and length of Lamination for greater side coverage.

395 FIG.6. Reflects the fully completed product with both the Laminations in place where, 70 refers to the bottom Laminated part and 71 refers to the top and side laminated parts. Note the core is completely covered with the Laminations.

FIG.7. Reflects an exploded view of a side surface expressing the coverage by each Lamination where 70 refers to the bottom Lamination and 71 refers to the top Lamination.

400 Here it is shown that the top Lamination covers most of the side surface and that there exist and overlap to ensure firm and seamless coverage. In this case on a typical product with a height of 85mm, the top Lamination covers 65mm of the side surface and the. bottom Lamination covers 35mm of the side surface resulting in an overlap of 15mm. This holds true to all side surfaces.

405 Best mode for carrying out the invention

As it was expressed throughout above discussions there exists two main parts for the product. They are namely the natural Latex inner core and the other the Lamination film. First and fore most the size of the mattress needs to be identified as fit for the industry in concern. For this purpose a research was conducted throughout many hospitals in Japan

410 and arrived at the following most preferred sizes. W780mm x Ll 910mm x H85mm W830mm x L1910mm X H85mm W910mm x L1910mm x H85mm (where, W= width, L=length, H=height)

415 The height was further subjected to ergonomic tests and confirmed that the 85mm was the best possible option considering the comfort and ease of handling the product. Also it was further confirmed that a density of 85 on the Latex hardness scale be considered for the product to deliver the intended features of comfort. The production of the inner core follows an already well established latex foam mattress

420 manufacturing process. This is known as the Dunlop process. Since the process is commonly practiced, a detailed description is avoided though following highlights are expressed as relevant for the comprehension of carrying out the invention. The inputs to the process would be natural Latex from the sap of Rubber which at the compounding and dispersion stages is mixed with various agents including the ones for the provision of

425 gelling and foaming. This dispersion as it is normally addressed is then injected as foam to an array of closed moulds. Once the moulds are fully and evenly filled with they are sent through a steam chamber to activate the vulcanizing process which solidifies the Latex. Once the moulds cool down they are opened and the now hardened mattresses are taken off the moulds. A point to note is that the moulds are most often designed to best suit the

430 dimensions of the end product requirement and also special emphasis is given to the density requirement (comfort level as required by ergo checks) by the application of what is known as pins on the moulds. The size of the pins that creates holes in the mattress determines the amount of Latex applied to a mattress and hence it's density. The pins also help the vulcanizing process delivering a dual benefit. Subsequently mattresses that are

435 taken off the moulds are sent through a thorough washing process to take away most of the agents that were initially introduced. This activity is responsible for bringing purity back into the product and the resultant proclamation of the pure natural latex mattress. Once the mattresses are thoroughly washed they are then sent through a radio frequency (RF) drying mechanism to completely disperse all water content. The outcome is a pure fully dry

440 natural latex mattress. In the case of smoothening edges and further dimension requirements they are then sent through cutters to obtain perfectly sized pieces. These perfectly sized pure Natural Latex mattresses are the ones that will then be considered as the inner core for the invention. Please refer FIG.l Next activity is to produce the lamination material. Here too standard and established

445 Polyurethane film manufacturing methods are considered such as Blown Film method and Extrusion method. Reflecting on the best mode though the Extrusion method is suggested for the ease of infusion of other special material as is required for the end product. Extrusion method in simple is the forcing of melted material through a Die with an opening of the required shape and then cooling down immediately after the material

450 extrudes off the Die. The basic process contains a vertical container called the hopper where plastic resins, pellets or flaxes are entered (special other materials added at this stage) which then feeds them to an extruder unit. The steel extruder is responsible for converting the solid pellets to a melted liquid and forcing it down to the Die. For this purpose the extruder has a long screw type device inserted through a tube which rotates

455 continuously. The Resins are fed into this tubing and are crushed to a melt by the screwing action. The screw angle is designed to flow the crushing action towards the Die and as such when the material reaches the Die it is well melted and is in a viscous state. Further screw action from this point converts to a pumping action as it forces the melted material out of the Die which has an opening as desired for the product. A point of emphasis here is

460 that the Die in concern should be selected for plastic film processing. The thin liquid layer extruding off the Die is then immediately sent through rotating rollers (the clearance known as nips) which are constantly cooled. The assembly of rollers which are generally known as down stream equipment will be responsible for solidifying and maintaining the size of the film. 465 The resins and resin ratios applied during the process determines the features of the polyurethane film. The thickness of the film is understood to be as thin as possible without of course loosing the required durability. This is due to the fact that emphasis is applied to deliver the natural comfort from the Latex inner core and as such least amount of external material is considered. Accordingly owing to many tests and research we have found the

470 appropriate film thickness to be at 40 microns.

As expressed in previous discussions two types of lamination films are required for the end product. Whilst both lamination films will have the main characteristics of water, air impermeability and resilience to heat and alcohol one lamination film would contain a minor infusion of adhesive on its top surface that would deliver an effect of friction. This

475 particular lamination film is the one that will be applied to the top and side portions of the product which gives the valuable feature of friction where the patients and linen find easy to be set on the mattress and will not slide down or slip away. The top surface of the other lamination film will however not have any adhesive type material and will be further infused with finer resins to deliver a complete frictionless surface. This frictionless

480 lamination film will be the one that is applied to the bottom of the product which will enable the mattress to be easily placed on and off the beds. The bed guides or railed edges would be the supports that would keep the mattress in place. Once both the types of lamination films are developed as above, the inner side of the lamination films or the bottom surfaces of the lamination films are applied with a thin film

485 of strong adhesive that will act as the binding to the inner core. The specially selected adhesive is placed in a bath with a roller fixed on top. One part of the roller is submerged in the adhesive bath and the lamination films are rolled over on the other, exposed, part of the roller through a roller assembly. When the roller turns, the adhesive in the bath gets spread on the roller and in turn the adhesive on the roller gets attached to the lamination

490 film which travels on top of the roller. In this manner a very thin and even application of the adhesive is ensured. The completed films will have two paper based covering layers to protect both the top surface and the adhesive based inner surface. The lamination films will be produced in rolls and stored for usage on requirement. Please refer FIG.2. The width of the lamination film will depend on the dimensions of the core and or product

495 requirement. Having to cover the side surfaces the width of the film is usually in excess of the width of the core by twice the height of the core especially in the case of the top lamination.

At the final production stage both the inner core and the lamination films are carefully delivered as individual items to the facility. A final assessment of the order requirement is

500 carried out in terms of dimensions, weight and density (comfort) of the inner core before the application of the lamination films. On confirmation the inner core is placed on a smooth contamination free surface. A rightly cut piece (with provision for covering part of the side surfaces) of bottom lamination film (frictionless type) is then care fully placed on the inner core with its inner adhesive applied surface exposed towards the inner core.

505 Please refer FIG.3. It is then neatly spread by hand to a complete bonding and will be extended to the sides to about 35mm (generally about 40% of the height) from its height of 85mm on all of the side surfaces. It is immaterial at this stage which main surface of the inner core is considered as the top since there is no change to the Latex characteristics on either side. The top and bottom of the final product is purely decided upon by the type of

510 lamination film applied. Having done the above step the bottom surface of the final product is now complete. Please refer FIG.4. The exercise is then repeated to the other side of the core this time applying the friction type lamination film making that surface the top of the product. Please refer FIG.5. In this step however the sides will have to be extended to fully cover the remaining areas of the side surfaces overlapping extended edge

515 of the bottom lamination film. Care is taken to limit extension before the end of the bottom surface. This is to make sure that the end points of each lamination are away from the edges of the mattress to avoid strip out during handling. In this case the side lamination film will be extended up to about 65 mm from top which will over lap the bottom edge of lamination film by 15mm. Please refer FIG.7. In general considering durability the

520 effective ratios are kept in and around 40% of side coverage of the height by the bottom lamination film and the over lap of the two laminations to be within the frame of 15-20% of the height on the side surfaces. The specifics however are subject to change according to final product dimension requirements. Special emphasis is vested upon the production steps where the bottom surface of the product is to be completed before the top and the

525 steps should not be reversed. This is due to the edge of the bottom lamination film otherwise being exposed towards the top of the product, where vulnerability for contamination exists in case of liquid spill out. Once both the laminations are carefully secured to the core the final product is complete. Please refer FIG.6. The entire final production process (i.e. combining the core with the

530 lamination film) is carried out by hand to ensure delicate handling of the lamination film, even placement on the core, hygiene and simultaneous primary quality check. In the empirical context our manufacturing facilities have arrays of human driven assembly lines for carrying out the finishing process. It is very important that the facility must be of very high hygienic standard to prevent any type of contamination of the inner core before the

535 application of lamination.

As a special case let us now reflect on the application of special therapeutic material which delivers the self therapeutic capabilities of the product. As was explained during the disclosure, sections e) under the lamination two naturally occurring radio active materials (NORMs) found by eminent scientist in Japan are used. The specific materials with

540 described characteristics (deodorant, antibacterial, infrared and hot spring effect) have been identified as Inoue ore (stone) and Futamata ore (stone) which are classified and filed under the protection of the respective founders. The material when finely ground appears as a powder. This powder is then infused during the lamination manufacturing process. It is also described as kneading the powder to the lamination film material. Subjected to

545 many tests and research it was found that an approximate value of 1 part to 100 parts of the lamination material was suffice to effect the hygienic (deodorant effect, antibacterial effect) and therapeutic (infrared rays and hot spring effect) values. As such the lamination can be manufactured to contain these effects and subsequently be placed on the inner cores to complete the self therapeutic end product. As per requirement it is also possible to apply

550 these NORMs on to the inner core manufacturing process (Latex foam manufacturing process) which avails even the inner core to contain self therapeutic effects. This was also tested and the cores were subjected to the earlier discussed Antibacterial Efficiency Test JIS Z 2801 :2000 5.2 which delivered encouraging results. As per the final product in concern though (The Hygienic, Infection Free, Therapeutic Mattress) the infusion of these

555 values to the lamination method was selected. As was the case during the disclosure here too it is re-iterated that further efforts are being applied to enhance the self hygienic and therapeutic effects of a mattress with the application of titanium dioxide (Tiθ2) which also is considered as an alternative inventive step in the main inventive concept. Industrial applicability

560 The Hygienic Infection free Therapeutic mattress was originally designed to aid the recovery process of patients. Hence the predominant application would associate with after care services. As such Hospital care, Aged care, Rehabilitation care would be the areas of consideration for the product. In the context of after care infection, significant concerns world wide associate with the

565 hospital care industry where a notable amount of cases succumbed to the wrath of MRSA a grave problem under HCAI. Since patients come with various sicknesses the vulnerability of mattress contamination too is high during hospital care. Also in general hospital care is considered short term and a bed may be used as much as by 10-15 patients a month, widening the scope of infection and restricted time for good hygiene practices.

570 Considering the expressed features of the product especially it's design for faster patient turnaround and ease of maintenance it is understood that the product best suits the hospital after care services industry.

The product is supplied as one complete unit with no external assembly requirement. Its seamless integration to existing beds makes the applicability much easier and the

575 conversion of existing conventional, hard to maintain, dirty beds to super hygiene and super comfort beds is easy and instantaneous. They would be as complete as their installation at a brand new site. The dimensions of the product expressed earlier are the ones most commonly used, however in the event of any differ the cores can easily be cut and shaped to any customized requirement.

580 The product's level of comfort and bedsore eliminating feature avails its applicability for long term bed ridden applications and in that context aged care and rehabilitation services industry can be considered. The ease of maintenance too compliments this application. Further more the product could also be considered for home use and some mobile applications such as caravans etc utilizing its comfort, flexibility, durability and ease of

585 maintenance features. Of course the justification of cost for such application should be considered.

The product will be branded to reflect its main purposes, namely ease of maintenance and care for patient. Hence it is named as CareEasy and is introduced to the market as such. Individual units will be simply packaged and will be available in ready to use condition.

590 Considering the areas of applicability, CareEasy will be mainly targeted to hospital services companies and the usage will be justified primarily on cost comparing the time consuming complex cleaning practices associated with conventional mattresses. This has proven to make good business sense since research has shown that the product is capable of reducing maintenance costs significantly. Also this forms a very effective and fruitful means for product penetration. The immeasurable and unique values of the product will then take position to place CareEasy well above the existing products in the market whilst addressing issues of HCAI a significant and growing concern in the industry. Further marketing efforts are drawn up to apply the product with additional services such as 1 year 1 to 1 replacement. In summery the product is designed to deliver absolute comfort, absolute hygiene with therapeutic effects combined with absolute ease of maintenance. As such where ever patient care and or bedridden care are warranted the value of CareEasy is immeasurable.

Claims

1. The invention of a Hygienic, Infection free Therapeutic Mattress where, features of absolute hygiene characterized by the elimination of contamination, non infectious effect characterized by resilience to bacteria and easy cleansing design and self therapeutic effects characterized by infusion of special therapeutic material coupled with natural Latex comfort have all been combined and effected through one uniquely designed mattress product. The product contains a natural Latex core covered with a specially developed Lamination film seamlessly pasted on all its surfaces. The Lamination film with its resilience to detergents, alcohols and hot water coupled with a frictionless surface at the bottom characterizes ease of maintenance.

2. Claim (1) suggests a Therapeutic mattress that aids quick patient recovery characterized by natural Latex comfort and invigorating effects of special therapeutic ingredients.

3. Claim (1) suggests a Hygienic mattress characterized by special features of water and air impermeability resisting all types of external contaminants.

4. Claim (1) suggests an Infection free mattress characterized by self resistance to bacteria and odor and its resilience to bacteria cleansers such as alcohols detergents and hot water.

5. Claim (1) suggests a unique hospital mattress characterized by its hygienic and non infectious features to be used for hospital care acquired infection counter efforts.

6. Claim (1) suggests a Natural latex core covered fully by a durable self adhesive Lamination film characterizing a seam less and fine edge product design.

7. Claim (1) suggests a laminated mattress characterizing a clean and well protected inner core.

8. Claim (7) suggests elimination of oxidation of the inner core characterized by the air impermeability feature of the Lamination, effecting considerable usage periods of the product.

9. Claim (1) suggests the use of Natural latex core with low internal pressure (IP) characterizing smoother blood circulation and elimination of bedsores.

10. Claim (1) suggests the infusion of special ingredients to a mattress characterizing self therapeutic values.

11. Claim (1) suggests design for easy maintenance of a mattress characterized by a special Lamination that restricts contamination to the surface.

12. Claim (1) suggests elimination of contamination of a mattress characterizing a significant step towards hygiene.