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“The Vacuum-Dry Diaper:
 The Diaper That Likes to Stay Dry”




           Presented By:
Carlos Richer and Virginio Marconato




   Richer Investment S.A. de C.V.
       -Diaper Consulting Services-




                                      Insight 2008
                                      15 Oct, St. Louis MO

                                                   1
After half a century…Oh my, you disposable diaper thing, you are getting old!

The human race realized something was urgently needed when they were confronted with the
horrible and smelly mess resulting from accumulated human wastes being discarded in public
places, like the organic waste generated by small babies and adult incontinent people. It was not
only a requirement for the modern civilized world, but also an imperative need for sanitation and
good public health.

It was this need and men’s creativity that resulted in the invention of diapers. Disposable diapers
were developed as a natural step in the evolution of the cloth diaper that had been with us for
several centuries. Disposable diapers have been used for almost 50 years since the time they
were first conceived for mass distribution at the end of the 50’s, when Vic Mills took his famous
summer vacation with his baby grandson, which lead to the development of Pampers.

In all this time, disposables have evolved from the primitive products of the 60’s, that used multi
layers of crepé tissue paper on top of a plastic backsheet and a rayon nonwoven cover to the
modern diapers that we have today; with fancy printed cloth-like backsheet, sophisticated high
performing acquisition layers, fluff and curly fibers mixed with superabsorbent, mechanical
closure systems, and elasticized ears.

A key issue to understand is that all diapers, new or old, share the same basic principle and
unfortunately the same original design flows; it will become more obvious after reading the
following definition. From Wikipedia: “A diaper or nappy is an absorbent garment worn by
individuals who are incapable of controlling their bladder or bowel movements, or are unable or
unwilling to use a toilet. When diapers become full and can no longer hold any more waste, they
require changing; this process is often performed by a secondary person such as a parent or
caregiver”. According to this definition, a diaper was invented to hold the organic wastes by
keeping them under control inside the diaper. Note that it is not just a collecting device; it is
designed to hold the liquids until it becomes full.

In this paper I will introduce a brand new patented technology that will not only challenge the
current understanding of the purpose of a diaper, it will also change the way we look at the
problem and challenge the whole industry to respond to the new opportunities presented here.

I will concentrate on the adult incontinence sector because in my opinion this is the sector that
has the most urgent need for this new technology, for reasons that I will later explain, however I
will also mention briefly how this new technology can be used in sanitary napkins, and with
tampons. In fact there are several other industrial applications where this new technology will be
a great success like when used to collect toxic spills and with agricultural applications.




                                                                                          2
Before we try to find solutions to the ancient problem of adult incontinence, let us first try
to understand it: What is Urinary Incontinence?

Urinary Incontinence is that condition under which the involuntary leakage of urine is significant
enough that it creates a hygienic and social problem.

Two people leaking in the same way, for example a few (demonstrable) drops through the
urethra are both classified as incontinent. While one of the two, if not constantly interrogated,
might not care about the problem, considers it as almost normal and keeps having a normal life;
the other one, because of his/her self perception, because of his/her life style, because of his/her
commitments, might consider the same modest incontinence as totally incompatible with his/her
life style.

In fact many men and women, when they start “leaking”, they become “incontinent”, they
become embarrassed, isolated, stigmatized, depressed and some even face regression.


Continence requires:

•   Functional and anatomical integrity of the last trait of the urinary tract
•   Adequate mental activity
•   Self sufficiency
•   Motivation and physical skill

Every one of these points, taken alone or combined with others, can become a target of
pathological conditions which have high prevalence among the elder population and lead
continent persons not to be continent anymore. Urinary incontinence is such a wide spread
problem that an international society (International Continence Society) has been created in order
to study this pathology.


DIMENSIONS OF THE PROBLEM

Female Urinary Incontinence

Prevalence 20-50%

20-30% in the juvenile belt
30-40% in the middle age belt
30-50% in the elder belt

Only 11% is transitory (because it is mainly stress incontinence due to the failure of the sphincter
system) so the number of women affected by chronic incontinence is enormous.




                                                                                           3
Male urinary incontinence

There are not many studies for males (from the International Continence Society).
The prevalence is about 50% less than the female one. The incidence is close to 9%.

It is transitory in the 27% of the cases (urge incontinence linked to overactive bladder). Prostate
and intestinal inflammatory diseases can determine a higher incidence of incontinence).

Regurgitation incontinence (retention by B.P.H.- Benign Prostatic Hypertrophy-)
Urge urinary incontinence (40-80%)
Mixed incontinence (10-30%)
Pure stress urinary incontinence (10% after surgical e.g. Radical Prostatectomy or TURP)




CLASSIFICATION OF URINARY INCONTINENCE (male and female)

1. Stress incontinence

2. Urge incontinence

3. Mixed (1+2)

4. Overflow (retention)




ANATOMY/PHYSIOLOGY

Urinary continence is a physiological state guaranteed by the interaction of 3 corporal districts:

1. Brain, it recognizes the stimulus that comes from the bladder

2. Spinal Cord which rules the reflexes necessary to the function of reservoir of the bladder

3. Integrity of sphincter mechanism and it’s anatomic relations

Incontinence is due to failure of one or more of these following 4 “points” (which are the most
important answers that the specialist wants to know during a Pressure/Flow Study of bladder):




                                                                                           4
S.C.D.U.
Once the urine arrives, the bladder expands itself progressively and it periodically gives signals
(the stimulus) which we usually can postpone until the filling is not excessive in order to fill and
empty the bladder reservoir as we deem necessary:

Sensibility (S ) (that can be + than normal, normal, or - than normal)
Compliance (C) (that can be + than normal, normal, or - than normal)
Detrusor muscle (D) (that can be + than normal, normal, or - than normal)
Urethra (and sphincters) (U) (that can be + than normal, normal, or - than normal)

Sensibility (S ): + than normal (for irritation) can be cause of incontinence; sensibility - than
normal (like in neurological cases) can be cause of incontinence for overflow (too full).

Compliance (C): + than normal (like in neurological or in bad habits) can be cause of
incontinence for overflow (too full); compliance - than normal like in loss of capacity (reservoir)
like in chronic affection post radiotherapy.

Detrusor muscle (D): + than normal (like in neurological overactive bladder incontinence for
not inhibited contraction of bladder); detrusor - (like in neurological low contraction of
bladder not void incontinence for overflow).

Urethral and sphincter (U)
This structure is represented by the muscular fibers of

1) Bladder neck                    }     (internal sphincter)

2) Intrinsic urethral mechanism

                                   }        (2+3= external sphincter)

3) Extrinsic muscles.

Woman                                           Man




                                                                                           5
When the bladder is full, a conscious command generates the contraction of the detrusor
(muscular fibers inside the bladder wall) and the contemporary overture of the muscular
bladder neck fibers, the fibers of the intrinsic mechanism and of extrinsic muscles
(muscles of pelvic floor); this correct dance of contractions and relaxations permit
continence.


In the woman

We can say that, prior to a woman’s 50 years of age, incontinence is given mainly by a
bad functioning of the urethra’s sphincter’s mechanism which makes urine leak when a
physical effort, even a very modest one (like coughing, climbing the stairs, sneezing or
laughing), is done.

After menopause the cause becomes the involuntary contraction (overactive bladder),
which leads to the inability to wait for voiding after the perception that the bladder is full
(generally idiopathic).

A cause that is common to all the ages is the relaxation of pelvic floor (support’s
damages or sphincter incompetence). If sphincter mechanism is in the right position,
abdominal pressure is correctly transmitted to urethra (closure) and there is no leakage:




If sphincter mechanism is in wrong position, abdominal pressure is not correctly
transmitted to urethra (not a total closure) and there is leakage.



                                                                                            6
During pregnancy, the prevalence of incontinence is from 30% to 60% (sphincter
mechanism can be “pushed” in wrong position), like when there is prolix, or obesity, etc.

Urge functional (but definitive) incontinence is also secondary to neurological
pathologies (important walk limitations, reflexes’ mechanisms’ alterations e.g. because of
different reasons people are no longer able to reach the bathroom on time and they are
even no longer able to control the normal stimulus to urinate.

Summary of Urinary Incontinence

Often different kinds of urinary incontinence are associated so in order to better
understand the problem the doctor has to examine, for e.g. with the anamnesis:

   a) Duration, frequency, entity and characteristics of the urinary incontinence;
   b) Symptoms referable to disorder of the low urinary trait like urge, frequency,
      dysuria, etc.
   c) Modifications of the continence state associated to the appearance and/or
      worsening of alterations of the cognitive state and of the mobility, social-
      environmental changes;
   d) Use of absorbers or other devices;
   e) Alterations of sexuality or of the alvo;
   f) Habits in the consumptions of liquids;
   g) Medicines;
   h) Previous surgical or medical treatments;
   i) Expectations on the results of the treatment…


                                                                                        7
To complete the anamnesis, the voiding diaries (edited for 2-3 days by patient) and
many other clinical or instrumental tests are needed to study a patient with urinary
incontinence. The objective is to identify not only the pathological conditions that can
cause incontinence and therefore influence the prognosis, but also to evaluate the general
health, cognitive and functional state, his/her self perception, his/her life style, his/her
commitments even for the same kind of incontinence or the same volume of leakage, or
the same age, etc.

Because every patient has to be treated in a peculiar way, a single standard solution is a
good solution only for a little number of subjects. Only a solution that can provide a
personalized answer to every one of them is the right solution.


Size of the adult incontinence market in the USA and the world.

Urinary incontinence affects more than 15 million Americans in community and
institutional settings in 2008; these are merely the people that have accepted the fact that
they have an incontinence problem. The actual size of the market is much larger. Thirty-
eight percent of non-institutionalized patients older than 60 years of age experience
urinary incontinence, and almost 50 percent of institutionalized patients. More than 2.4
billion Dollars of adult incontinence products are expected to be sold in the United States
in 2008. The institutional market consumed more than 2.3 billion units and the consumer
market used more than 2.7 billion units just in the United States. In comparison to
worldwide adult incontinence, the market potential for the USA represents less than 10%
of the world market needs.


Well, now that we know what causes urine incontinence and the size of the market,
let us pause for a minute to meditate on what has been our current approach to this
sensitive condition, and why we urgently need to break this paradigm and provide a
better solution:

It is clear that in adult incontinence as well as with babies, the largest problem to solve is
urinary incontinence. In the case of adults, fecal incontinence even when we know it
exists and it is an important problem to solve, it is several orders of magnitude less
frequent and for sure much less frequent with adults than with babies that have not been
potty trained.

If urine and humidity in general, is the most important reason for skin disease problems
and comfort issues associated with the use of a diaper; does it make sense to manufacture
a product that is designed to keep the urine in close proximity to the skin?

If urine smells bad and it is also highly embarrassing for the adult incontinent user that is
socializing, does it make sense to keep the urine inside the diaper exposed to the
environment? Does it make sense to mask the odor with chemicals, when we can remove
almost the entire odor by simply removing the urine from the diaper



                                                                                            8
If the bulky size of a diaper is often rated the number one concern in focus groups due to
personal discretion and comfort issues, does it make sense to use high loadings of SAP
that we know will make the diaper grow in volume once wet, when it is possible to
achieve the same level of dryness, if not much better, by extracting all the liquids and
remaining thin and discreet?

If it takes time and great effort to change the diaper of a handicapped person or anyone
with limited mobility, does it make sense to manufacture a diaper that will keep him/she
wet and un-comfortable while he/her is waiting extended lengths of time until the next
diaper is finally changed?

Does it make sense to pollute the environment with an excessive amount of diapers when
it is possible to achieve a much better quality of life and reduce the total number of daily
diapers by less than half at the same time?

If you had a choice, would you rather like to store your organic waste fluids close to your
skin where you can feel them getting cold every time you apply pressure (for example
while sitting down) when you had the option of extracting all of the liquids in a discrete
way far away from your skin and remaining with your skin warm?

Don’t you think incontinent people would sleep better at night simply by making sure
they will be always dry and comfortable while in bed?

Would you like your taxes to be spent in additional an unnecessary incontinence care in
government institutions?

As an incontinent individual, would you like to spend more money taking care of your
own urinary incontinence?

Why would you pay more for the use of SAP when you can have a better diaper by
simply replacing the SAP with “cost free” vacuum?


Removing liquids from a garment is not new, so what’s new about this technology?

There are many systems available today with the purpose of collecting and removing the
urine from a garment using an external bag or similar container; some of them with a
direct catheter connection to the urethra; others using a simple bag with a check valve
and attached at the leg using a small plastic cup or funnel to catch the liquids and
allowing gravity to do its job. None of these systems have been proven to be truly
successful in the market, except in small micro niches, because they are either too
uncomfortable for extended wear or because they leak. Other systems rely on the
supposition that the user knows ahead of time when he is ready to pee (like the disposable
toilet, a simple bag with SAP), and most of them are not discreet enough or cannot be
used except in a private place. Mark Harvie invented a urine control system in 2004 that
suggested the use of vacuum using a battery operated pump with an electronic sensor and



                                                                                          9
an inflatable internal balloon designed to collect urine from personnel in long military
operations, like with extended fighter airplane missions or military ground operation, for
example inside a tank. Because you cannot generate the vacuum power needed with a
small 1.5V battery, the required battery and the size of the pump in addition to the
electronic sensor required to detect the urine, make the system extremely expensive for
normal mass commercial use (look at http://www.omnimedicalsys.com to look at current
prices). In addition these systems are large and bulky and require the use of an expensive
battery similar to the batteries used on a laptop computer. It is obvious that current
technology did not have the knowhow, like the pre-charged vacuum container and the
simple mechanical control valve system that we now present in this new product.

It is clear we cannot continue with the old reference, the new definition for a diaper
has to change, the adult diaper of today does not provide a good answer anymore.
It is time to break all the rules!

One of the problems with the commercial products available today, is that they are often
left for long times on the users, especially for those bedridden incontinent people, those
with mobility problems who have to use wheelchairs, or those that have to be assisted by
a nurse or guardian. Even for healthy active adults with incontinence using disposable
products, it is often difficult for them to find a place to change the product so they have to
keep using it until they find an opportunity to change it. This translates into irritated skin
and sometimes maceration or other skin diseases.

What is the proposed solution to the adult incontinence problem?

A new kind of diaper technology, instead of being designed to hold and keep the urine
locked inside the product; the new design will keep itself dry by removing the fluids
continuously and automatically. This new invention that I now present does not require
the use of any kind of electronic sensing devices; it does not require the use of any
battery or electrically operated pump to generate the required high vacuum needed to
start the suction of the liquids; and because of its unique “liquid sensitive valve design”,
the regulation system can start up the suction of the urine or organic fluids automatically
and without the risk of losing any of the container’s vacuum capacity due to the suction
of air previous to the actual insult with liquids, or due to the extended shelf time of the
product before it is being sold to the consumer.

This present invention introduces some novel ideas for the construction of the suction
device (or also referred here as a “salt valve” or “liquid sensitive valve”), and some
practical applications designed to improve the efficiency and at the same time simplify its
reliability at a very low cost, making this new invention very attractive to anyone with
incontinence and competitive in price to other typical incontinence products currently
sold but with significant advantages.

It can achieve this purpose without the need of any electronic sensor, without electric
motors or batteries due to its simple design as I am going to show. In addition, it works
best without the need of superabsorbent and can be made extremely thin. The resulting



                                                                                           10
diaper is drier to the skin, almost odorless, with better rewets and with much less cost per
day and similar costs per unit. Its overall working capacity is basically unlimited. We are
planning to replace SAP with free and always plentiful “vacuum” and prove without a
doubt that this is a better solution for adult urinary incontinence care than anything
available today. Liquids will be extracted from being close to the skin contact using a
small reusable external container which can be anatomically designed to be also portable.
The system can be recharged with vacuum as many times as needed without having to
remove the diaper from the user.

Introducing the new Vacuum-Dry diaper: the diaper that likes to stay dry.

The invention relates to the removal of organic liquids from absorbent products such as
diapers and sanitary towels and the like; in particular relates to the use of a regulated
suction device operated by a “salt valve” or a “liquid sensitive valve” connected to a
vacuum container for the removal of organic liquids for hygienic and sanitary uses.




The whole system is comprised of four individual components interconnected:

   1- A container previously charged with high vacuum (under high negative pressure).
   2- A suction tube with flow rate regulation control.


                                                                                         11
3- A “liquid sensitive” starting valve.
   4- And a disposable diaper (specially made for this purpose, with no sap).




How does it work?

The high vacuum container, preferably charged with 15 to 30 Psi of negative pressure (this is
free of any cost), is connected to a suction tube located inside the diaper using a liquid sensitive
valve in its path. The valve remains closed, avoiding any loss of vacuum from the container until
there is enough urine inside the diaper to activate the automatic opening mechanism that opens
the valve. Once the valve is opened, the suction generated by the vacuum container collects the
liquids in the diaper basically by capillarity and permits the transport of the liquids with the use
of a connecting hose (catheter) until they are safely locked inside the container where they
remain until discharged. The time delay required to activate the valve as well as the required
flow rate can be easily controlled to better adapt to each kind of incontinence (as I will later
explain). Once the container is full of liquid, the urine can be discarded into a toilet and the
container can be recharged with new vacuum and re used as many times as required until the
diaper is disposed. The diaper with the suction device and the liquid sensitive valve can be
discarded, but the container is reusable.


Let’s take a look at each component:

   1- The vacuum container.

The container can be made of many materials, like any hard plastic, metal, glass, etc. It just has
to be strong enough to stand the high negative pressure without being physically deformed by the
vacuum. The simplest form of the container is just an empty bottle with a shut off valve used to
open or close the bottle. The same valve can be used to recharge with vacuum using an external
manual pump. This way you can have one or more spare bottles already charged with vacuum
and use as needed. A more sophisticated design of the container can have a manual piston
already integrated to the container; this manual pump can be used to generate the required
vacuum by pushing the piston several times with the thumb until the high vacuum is achieved.
An even more complete system can have a mechanical pressure indicator (such as a simple
spring). The pressure indicator can show in an easy way whether or not the container has any
vacuum left and when it has to be recharged (just by looking at the position of the piston, fully
extended or retracted). This way you can easy prevent an accidental failure of the system by
alerting the user when there is low vacuum in the system. The size of the container can be easily
adapted for portability, like when used by mobile incontinent users (for example less than 250
ml), or can be of larger size, like when used by handicapped people in a wheelchair or people in
the bed (for example from 400 to 750 ml). A small battery could also be used as an option in
order to alert the user with a sound or with a vibration signal when the vacuum is getting low,
this could be another way for preventing a malfunction due to low vacuum.




                                                                                         12
2- The suction tube with flow rate control.

In its simplest form, the suction tube is just a piece of plastic tube connected to a catheter hose
small enough to be inserted comfortably and discreetly deep into the diaper. At the inserted end
of the tube, a piece of cotton with an extended length is placed into the tube with pressure. The
amount of pressure used and the amount of length of cotton inside the tube can easily be adjusted
to control the required flow rate once the system is activated. This flow rate can be adjusted for
patients with different kinds of urinary incontinence, for example like those that require a high
flow rate in a short time, and those that leak just a few drops per minute but continuously (for
example only 1 ml per minute or less). Table 1 shows a correlation between flow rate and cotton
length in one particular application. Another way of controlling the flow rate is using a flow
control valve or different diameter hoses. The cotton inside the tube prevents the entrance of gas
but permits the suction of liquid due to the capillarity flow within the cotton fibers. For this
function to operate correctly it is necessary that the cotton fibers are wet or at least semi-wet, if
they are dry they will take in air and loose vacuum. This is why the “liquid sensitive” valve is an
important key element and the brain of the whole system.




                                                                                          13
Length
Cotton
(mm)
      Flow
Rate
(ml/min)

                              20
                     1.3

                              10
                     4.3

                              
5
                     9.3

                               2
                      13

                               1
                      18


                    Table
1
Flow
rate
as
a
function
of
cotton

                       
Length
inside
the
suction
device





   3- “Liquid sensitive” valve.

The “liquid sensitive” valve has the function of closing the catheter that connects the vacuum
container with the suction tube and keep the connection closed until it detects the presence of
liquids inside the diaper. Once this happens, that valve remains open. This function is extremely
important as it is the only way to avoid the loss of vacuum while the system is waiting for the


                                                                                       14
first urine insult of the user. It can be easily incorporated by a simple mechanical action without
the need for batteries or electronic sensors.


Here a list of several options available:

   1- The use of a “salt valve” operated by a grain of salt that closes the connecting hose using
      direct mechanical pressure (like an open electrical terminal). When the liquid dissolves
      the salt after a short delay, the valve opens as there is no more obstruction.
   2- The same “salt valve” using a pressure chamber or mechanical spring to assist the
      opening of the hose once the salt has dissolved.
   3- The use of “medicine-like” capsules. After contact with water the capsule softens and the
      valve is open. The time delay required depends on how thick is the capsule and the
      number of capsules used. Table 2 shows and example of the correlation between open
      time and one particular kind of capsule.




                  Samples of liquid sensitive valve (electric terminal and Medicine cap)




                                                                                        15
Table 2 Using two different medicine caps to
                 control the start timing of the suction




Liquid Sensitive Valve (medicine cap design) integrated with Suction Device




                                                                              16
4- Disposable Adult Incontinence Diaper:

Even when it is possible to use a regular commercial diaper with some minor adaptations, the
system works better when the superabsorbent is completely removed from the diaper. The
reason is that the SAP is competing against the vacuum and it only makes it more difficult for the
vacuum to do its job. When the SAP is removed, the liquid can be easily extracted from the pad
without any additional efforts. The best diaper for this job is a diaper with a thick acquisition
distribution layer (a good ADL), to keep the skin of the user separated from the absorbent core,
and just enough liquid capacity and retention to hold the urine while the liquid sensitive valve is
activated by the contact with the urine without any risk of leaking urine out of the diaper. The
pad can be made of 100% fluff or it can also be fully synthetic, like air laid, curly fiber, or
similar materials. A preferred diaper design will have a pouch like a kangaroo that allows the
insertion of the suction control and the “liquid sensitive” valve (sold as a kit) deep into the
absorbent core. This way the kit will be in direct contact with the absorbent material and close to
the insult. An alternative option is to open a small tongue on the front top sheet, the kit is placed
on top of the pad and then the tongue is closed with soft Velcro material. A kit can be designed
for every kind of incontinence, with different time delays and different flow rate suctions. At the
beginning it may be sold with medical prescription. In the future, once the product is better
known, it will be sold over the counter without a prescription. This kit, with an initial estimated
manufacturing cost of 3 US cents per unit, will be connected to a vacuum container, one of the
many kinds of containers that I have already described. It is important to remember that this
container is fully reusable. The expected cost of the container is expected to be from 5 to 15
USD depending on the included options. The new diaper will have about the same
manufacturing cost than current commercial diapers because this new diaper does not need any
SAP, and the savings obtained from the SAP will probably pay for the kit and the use of a thicker
ADL. In addition, because there will be less diapers used every day, the actual cost of diapering
will be for sure much less than current practices. A good realistic estimate is that a typical user
will spend less than half of the money they spend today.




         Diaper with suction device KIT inserted into diaper in direct contact with fluff


                                                                                          17
It is not only cheaper, it is much better!

The new technology uses less resources and it is by far a better solution for the environment and
amazingly enough, for the final user too! There are no toxic products required and no additional
natural or synthetic resources; in fact the most important component of this technology is
NOTHING (yes, free abundant vacuum). It will result in less CO2 emissions and also in less
contamination to the landfill. There are many more social and economic benefits; for example, it
makes it easier for the nurse or guardian to provide quality care. It also reduces the cost of skin
care associated with diaper rash and maceration due to extended lengths in contact with the
urine. It improves the quality of life of millions of end user by providing a more comfortable and
discreet solution, both in diaper thickness and with regards to odor control. You can almost
forget about feeling the cold liquid near the skin every time you seat or apply pressure to a wet
diaper. It will be the closest thing to restoring a normal life to an incontinent adult. Draining the
container when needed will be almost equivalent to going to the toilet, as anyone else who is
continent. This new technology makes an incontinent person feel more like a continent person
again.



Benchmark of the Vacuum Dry Diaper .vs. Commercial products.


Unfortunately I cannot share laboratory results of the new vacuum-dry diaper prototype against
some of the best adult incontinence diapers in the world, as this work is currently under way at
this time and it was not ready on time for this presentation. In addition we do not have a
protocol to use with this new technology. Interesting to note is that while a commercial diaper
starts to have performance problems after a secondary or third rewet test, for the new vacuum-
dry diaper this issue is less relevant due to the unlimited capacity of the diaper after renewing the
vacuum, so we can test 3rd, 4th or 5th rewet if we ever wanted. We believe there are still a lot of
things to do to improve the design of a diaper that will be used with this new technology. For
example, we suggest using a much thicker ADL to help keep the skin of the user even drier. It is
also better to use special zones within the pad designed to move the liquid to a centralized
location in the diaper for an easier liquid extraction. One thing we have noted is that the current
vacuum-dry prototypes we have tested work better in women than in men. One reason is the
larger spread area for the urine in males when compared with females. We have modified the use
on men by adapting the “liquid sensitive” valve and the vacuum dry technology to a male “pee
cup”, made of a pad that is half open (similar to a long sanitary napkin folded in two). It is
designed for the easy placement of the penis and it can be closed with a Velcro tab, all other
edges sealed. Instead of a “leg cuff”, a “penis cuff” near the top is used for a good leakage seal at
optimal comfort. Although we cannot claim perfection at this time, we have enough evidence to
prove that this technology has a promising future and much lower costs; I also believe it will
replace many adult urinary products in the near future. How long it will take depends on you.




                                                                                          18
A live performance for the many skeptics: Seeing is believing!


I know all I have said so far may be difficult for many of you to digest; after all we have been
making disposable diapers in a very different way for the last 50 years, the best way we knew.
Many of you have invested lots of money in equipment and new technology. Pay attention, if
you do not understand the new concepts and pretend that nothing happened in this presentation,
you will end up missing the boat. I will do a live demonstration and I will challenge you to come
to the front and feel the diapers by yourself and inspect the individual components used. In an
industry that seemed almost mature, with only few small insignificant changes, finally a new
fresh idea that will change the way we think. Get ready! There is no magic, only a smart fresh
idea. This new technology is here to stay; I will make absolutely sure of that!


For the next step, you are invited to join us!

We are looking for a small group of companies who are willing to take this challenge to the next
step and move it from a simple prototype to a new mass merchandise reality. This new patented
technology will be a new reality that will improve the quality of life of millions of people all
over the world. The first companies showing a firm commitment to join us will have the greater
benefits and concessions.

 I have been in this industry for 25 years; during this time I was responsible for the manufacture
of more than 7 billion diapers. I have seen many diaper improvements during this time and have
visited diaper factories in many countries in my current job as an industry consultant. I believe
this experience has given me a unique global vision of the diaper industry. I strongly believe this
is one of the best inventions for the adult diaper incontinence industry ever. You can expect a fair
Win-win deal from somebody that understands this industry (by the way, the big W is your
company; we are only looking to get a very small “w” in this Win-win relationship). Finally, I
would like to challenge anyone who is still not a believer to give me a chance to present this
technology to your R&D and Marketing staffs. In these extremely critical financial times, it is
about time we get over the “Not Invented Here” syndrome and accept good ideas wherever they
come from. It is about time we find ways to stop wasting our precious resources. This is the only
diaper providing good answers to all the initial questions. This is the way how urinary
incontinence should be treated from now on! I think it is about time that we deliver a better
solution to the millions of incontinent people suffering this problem all over the world.




It is a small world, Get connected: use my LinkedIn to stay connected and join my Diaper
Industry Network group on LinkedIn.




                                                                                         19
You can download the videos presented in the conference using these links:

http://www.youtube.com/watch?v=eBUDVXhF7oc
http://www.youtube.com/watch?v=jsaVHTjFO9Q
http://www.youtube.com/watch?v=jLRxOueKxcM
http://www.youtube.com/watch?v=7qZreXAEtDQ
http://www.youtube.com/watch?v=9aoyd7RbbeI



My sincere thanks to the following individuals who provided important feedback and
insight in the preparation of this paper:


   -   Andrew Urban (Urban Consultants)
   -   Price Hanna (John Starr)
   -   Ricardo Zambrano (PGI)
   -   Bill Dehaas (Global Market Technologies)
   -   Juan Guadalupe Marcos (Lambi)
   -   Ivan Tava (Mova Marketing)
   -   Pat Gillis (Seattle)
   -   Doctors and Pharmacists from the city of Venice Italy and all people involved.
   -   My brother Eugene and sister Hilda who provided key constructive criticism.
   -   My nephew Eugene who made the very nice animations (Camaleon)
   -   To my wife and kids who helped with each stage of this project.




                                                                                        20

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Carlos Richer Insight2008

  • 1. “The Vacuum-Dry Diaper: The Diaper That Likes to Stay Dry” Presented By: Carlos Richer and Virginio Marconato Richer Investment S.A. de C.V. -Diaper Consulting Services- Insight 2008 15 Oct, St. Louis MO 1
  • 2. After half a century…Oh my, you disposable diaper thing, you are getting old! The human race realized something was urgently needed when they were confronted with the horrible and smelly mess resulting from accumulated human wastes being discarded in public places, like the organic waste generated by small babies and adult incontinent people. It was not only a requirement for the modern civilized world, but also an imperative need for sanitation and good public health. It was this need and men’s creativity that resulted in the invention of diapers. Disposable diapers were developed as a natural step in the evolution of the cloth diaper that had been with us for several centuries. Disposable diapers have been used for almost 50 years since the time they were first conceived for mass distribution at the end of the 50’s, when Vic Mills took his famous summer vacation with his baby grandson, which lead to the development of Pampers. In all this time, disposables have evolved from the primitive products of the 60’s, that used multi layers of crepé tissue paper on top of a plastic backsheet and a rayon nonwoven cover to the modern diapers that we have today; with fancy printed cloth-like backsheet, sophisticated high performing acquisition layers, fluff and curly fibers mixed with superabsorbent, mechanical closure systems, and elasticized ears. A key issue to understand is that all diapers, new or old, share the same basic principle and unfortunately the same original design flows; it will become more obvious after reading the following definition. From Wikipedia: “A diaper or nappy is an absorbent garment worn by individuals who are incapable of controlling their bladder or bowel movements, or are unable or unwilling to use a toilet. When diapers become full and can no longer hold any more waste, they require changing; this process is often performed by a secondary person such as a parent or caregiver”. According to this definition, a diaper was invented to hold the organic wastes by keeping them under control inside the diaper. Note that it is not just a collecting device; it is designed to hold the liquids until it becomes full. In this paper I will introduce a brand new patented technology that will not only challenge the current understanding of the purpose of a diaper, it will also change the way we look at the problem and challenge the whole industry to respond to the new opportunities presented here. I will concentrate on the adult incontinence sector because in my opinion this is the sector that has the most urgent need for this new technology, for reasons that I will later explain, however I will also mention briefly how this new technology can be used in sanitary napkins, and with tampons. In fact there are several other industrial applications where this new technology will be a great success like when used to collect toxic spills and with agricultural applications. 2
  • 3. Before we try to find solutions to the ancient problem of adult incontinence, let us first try to understand it: What is Urinary Incontinence? Urinary Incontinence is that condition under which the involuntary leakage of urine is significant enough that it creates a hygienic and social problem. Two people leaking in the same way, for example a few (demonstrable) drops through the urethra are both classified as incontinent. While one of the two, if not constantly interrogated, might not care about the problem, considers it as almost normal and keeps having a normal life; the other one, because of his/her self perception, because of his/her life style, because of his/her commitments, might consider the same modest incontinence as totally incompatible with his/her life style. In fact many men and women, when they start “leaking”, they become “incontinent”, they become embarrassed, isolated, stigmatized, depressed and some even face regression. Continence requires: • Functional and anatomical integrity of the last trait of the urinary tract • Adequate mental activity • Self sufficiency • Motivation and physical skill Every one of these points, taken alone or combined with others, can become a target of pathological conditions which have high prevalence among the elder population and lead continent persons not to be continent anymore. Urinary incontinence is such a wide spread problem that an international society (International Continence Society) has been created in order to study this pathology. DIMENSIONS OF THE PROBLEM Female Urinary Incontinence Prevalence 20-50% 20-30% in the juvenile belt 30-40% in the middle age belt 30-50% in the elder belt Only 11% is transitory (because it is mainly stress incontinence due to the failure of the sphincter system) so the number of women affected by chronic incontinence is enormous. 3
  • 4. Male urinary incontinence There are not many studies for males (from the International Continence Society). The prevalence is about 50% less than the female one. The incidence is close to 9%. It is transitory in the 27% of the cases (urge incontinence linked to overactive bladder). Prostate and intestinal inflammatory diseases can determine a higher incidence of incontinence). Regurgitation incontinence (retention by B.P.H.- Benign Prostatic Hypertrophy-) Urge urinary incontinence (40-80%) Mixed incontinence (10-30%) Pure stress urinary incontinence (10% after surgical e.g. Radical Prostatectomy or TURP) CLASSIFICATION OF URINARY INCONTINENCE (male and female) 1. Stress incontinence 2. Urge incontinence 3. Mixed (1+2) 4. Overflow (retention) ANATOMY/PHYSIOLOGY Urinary continence is a physiological state guaranteed by the interaction of 3 corporal districts: 1. Brain, it recognizes the stimulus that comes from the bladder 2. Spinal Cord which rules the reflexes necessary to the function of reservoir of the bladder 3. Integrity of sphincter mechanism and it’s anatomic relations Incontinence is due to failure of one or more of these following 4 “points” (which are the most important answers that the specialist wants to know during a Pressure/Flow Study of bladder): 4
  • 5. S.C.D.U. Once the urine arrives, the bladder expands itself progressively and it periodically gives signals (the stimulus) which we usually can postpone until the filling is not excessive in order to fill and empty the bladder reservoir as we deem necessary: Sensibility (S ) (that can be + than normal, normal, or - than normal) Compliance (C) (that can be + than normal, normal, or - than normal) Detrusor muscle (D) (that can be + than normal, normal, or - than normal) Urethra (and sphincters) (U) (that can be + than normal, normal, or - than normal) Sensibility (S ): + than normal (for irritation) can be cause of incontinence; sensibility - than normal (like in neurological cases) can be cause of incontinence for overflow (too full). Compliance (C): + than normal (like in neurological or in bad habits) can be cause of incontinence for overflow (too full); compliance - than normal like in loss of capacity (reservoir) like in chronic affection post radiotherapy. Detrusor muscle (D): + than normal (like in neurological overactive bladder incontinence for not inhibited contraction of bladder); detrusor - (like in neurological low contraction of bladder not void incontinence for overflow). Urethral and sphincter (U) This structure is represented by the muscular fibers of 1) Bladder neck } (internal sphincter) 2) Intrinsic urethral mechanism } (2+3= external sphincter) 3) Extrinsic muscles. Woman Man 5
  • 6. When the bladder is full, a conscious command generates the contraction of the detrusor (muscular fibers inside the bladder wall) and the contemporary overture of the muscular bladder neck fibers, the fibers of the intrinsic mechanism and of extrinsic muscles (muscles of pelvic floor); this correct dance of contractions and relaxations permit continence. In the woman We can say that, prior to a woman’s 50 years of age, incontinence is given mainly by a bad functioning of the urethra’s sphincter’s mechanism which makes urine leak when a physical effort, even a very modest one (like coughing, climbing the stairs, sneezing or laughing), is done. After menopause the cause becomes the involuntary contraction (overactive bladder), which leads to the inability to wait for voiding after the perception that the bladder is full (generally idiopathic). A cause that is common to all the ages is the relaxation of pelvic floor (support’s damages or sphincter incompetence). If sphincter mechanism is in the right position, abdominal pressure is correctly transmitted to urethra (closure) and there is no leakage: If sphincter mechanism is in wrong position, abdominal pressure is not correctly transmitted to urethra (not a total closure) and there is leakage. 6
  • 7. During pregnancy, the prevalence of incontinence is from 30% to 60% (sphincter mechanism can be “pushed” in wrong position), like when there is prolix, or obesity, etc. Urge functional (but definitive) incontinence is also secondary to neurological pathologies (important walk limitations, reflexes’ mechanisms’ alterations e.g. because of different reasons people are no longer able to reach the bathroom on time and they are even no longer able to control the normal stimulus to urinate. Summary of Urinary Incontinence Often different kinds of urinary incontinence are associated so in order to better understand the problem the doctor has to examine, for e.g. with the anamnesis: a) Duration, frequency, entity and characteristics of the urinary incontinence; b) Symptoms referable to disorder of the low urinary trait like urge, frequency, dysuria, etc. c) Modifications of the continence state associated to the appearance and/or worsening of alterations of the cognitive state and of the mobility, social- environmental changes; d) Use of absorbers or other devices; e) Alterations of sexuality or of the alvo; f) Habits in the consumptions of liquids; g) Medicines; h) Previous surgical or medical treatments; i) Expectations on the results of the treatment… 7
  • 8. To complete the anamnesis, the voiding diaries (edited for 2-3 days by patient) and many other clinical or instrumental tests are needed to study a patient with urinary incontinence. The objective is to identify not only the pathological conditions that can cause incontinence and therefore influence the prognosis, but also to evaluate the general health, cognitive and functional state, his/her self perception, his/her life style, his/her commitments even for the same kind of incontinence or the same volume of leakage, or the same age, etc. Because every patient has to be treated in a peculiar way, a single standard solution is a good solution only for a little number of subjects. Only a solution that can provide a personalized answer to every one of them is the right solution. Size of the adult incontinence market in the USA and the world. Urinary incontinence affects more than 15 million Americans in community and institutional settings in 2008; these are merely the people that have accepted the fact that they have an incontinence problem. The actual size of the market is much larger. Thirty- eight percent of non-institutionalized patients older than 60 years of age experience urinary incontinence, and almost 50 percent of institutionalized patients. More than 2.4 billion Dollars of adult incontinence products are expected to be sold in the United States in 2008. The institutional market consumed more than 2.3 billion units and the consumer market used more than 2.7 billion units just in the United States. In comparison to worldwide adult incontinence, the market potential for the USA represents less than 10% of the world market needs. Well, now that we know what causes urine incontinence and the size of the market, let us pause for a minute to meditate on what has been our current approach to this sensitive condition, and why we urgently need to break this paradigm and provide a better solution: It is clear that in adult incontinence as well as with babies, the largest problem to solve is urinary incontinence. In the case of adults, fecal incontinence even when we know it exists and it is an important problem to solve, it is several orders of magnitude less frequent and for sure much less frequent with adults than with babies that have not been potty trained. If urine and humidity in general, is the most important reason for skin disease problems and comfort issues associated with the use of a diaper; does it make sense to manufacture a product that is designed to keep the urine in close proximity to the skin? If urine smells bad and it is also highly embarrassing for the adult incontinent user that is socializing, does it make sense to keep the urine inside the diaper exposed to the environment? Does it make sense to mask the odor with chemicals, when we can remove almost the entire odor by simply removing the urine from the diaper 8
  • 9. If the bulky size of a diaper is often rated the number one concern in focus groups due to personal discretion and comfort issues, does it make sense to use high loadings of SAP that we know will make the diaper grow in volume once wet, when it is possible to achieve the same level of dryness, if not much better, by extracting all the liquids and remaining thin and discreet? If it takes time and great effort to change the diaper of a handicapped person or anyone with limited mobility, does it make sense to manufacture a diaper that will keep him/she wet and un-comfortable while he/her is waiting extended lengths of time until the next diaper is finally changed? Does it make sense to pollute the environment with an excessive amount of diapers when it is possible to achieve a much better quality of life and reduce the total number of daily diapers by less than half at the same time? If you had a choice, would you rather like to store your organic waste fluids close to your skin where you can feel them getting cold every time you apply pressure (for example while sitting down) when you had the option of extracting all of the liquids in a discrete way far away from your skin and remaining with your skin warm? Don’t you think incontinent people would sleep better at night simply by making sure they will be always dry and comfortable while in bed? Would you like your taxes to be spent in additional an unnecessary incontinence care in government institutions? As an incontinent individual, would you like to spend more money taking care of your own urinary incontinence? Why would you pay more for the use of SAP when you can have a better diaper by simply replacing the SAP with “cost free” vacuum? Removing liquids from a garment is not new, so what’s new about this technology? There are many systems available today with the purpose of collecting and removing the urine from a garment using an external bag or similar container; some of them with a direct catheter connection to the urethra; others using a simple bag with a check valve and attached at the leg using a small plastic cup or funnel to catch the liquids and allowing gravity to do its job. None of these systems have been proven to be truly successful in the market, except in small micro niches, because they are either too uncomfortable for extended wear or because they leak. Other systems rely on the supposition that the user knows ahead of time when he is ready to pee (like the disposable toilet, a simple bag with SAP), and most of them are not discreet enough or cannot be used except in a private place. Mark Harvie invented a urine control system in 2004 that suggested the use of vacuum using a battery operated pump with an electronic sensor and 9
  • 10. an inflatable internal balloon designed to collect urine from personnel in long military operations, like with extended fighter airplane missions or military ground operation, for example inside a tank. Because you cannot generate the vacuum power needed with a small 1.5V battery, the required battery and the size of the pump in addition to the electronic sensor required to detect the urine, make the system extremely expensive for normal mass commercial use (look at http://www.omnimedicalsys.com to look at current prices). In addition these systems are large and bulky and require the use of an expensive battery similar to the batteries used on a laptop computer. It is obvious that current technology did not have the knowhow, like the pre-charged vacuum container and the simple mechanical control valve system that we now present in this new product. It is clear we cannot continue with the old reference, the new definition for a diaper has to change, the adult diaper of today does not provide a good answer anymore. It is time to break all the rules! One of the problems with the commercial products available today, is that they are often left for long times on the users, especially for those bedridden incontinent people, those with mobility problems who have to use wheelchairs, or those that have to be assisted by a nurse or guardian. Even for healthy active adults with incontinence using disposable products, it is often difficult for them to find a place to change the product so they have to keep using it until they find an opportunity to change it. This translates into irritated skin and sometimes maceration or other skin diseases. What is the proposed solution to the adult incontinence problem? A new kind of diaper technology, instead of being designed to hold and keep the urine locked inside the product; the new design will keep itself dry by removing the fluids continuously and automatically. This new invention that I now present does not require the use of any kind of electronic sensing devices; it does not require the use of any battery or electrically operated pump to generate the required high vacuum needed to start the suction of the liquids; and because of its unique “liquid sensitive valve design”, the regulation system can start up the suction of the urine or organic fluids automatically and without the risk of losing any of the container’s vacuum capacity due to the suction of air previous to the actual insult with liquids, or due to the extended shelf time of the product before it is being sold to the consumer. This present invention introduces some novel ideas for the construction of the suction device (or also referred here as a “salt valve” or “liquid sensitive valve”), and some practical applications designed to improve the efficiency and at the same time simplify its reliability at a very low cost, making this new invention very attractive to anyone with incontinence and competitive in price to other typical incontinence products currently sold but with significant advantages. It can achieve this purpose without the need of any electronic sensor, without electric motors or batteries due to its simple design as I am going to show. In addition, it works best without the need of superabsorbent and can be made extremely thin. The resulting 10
  • 11. diaper is drier to the skin, almost odorless, with better rewets and with much less cost per day and similar costs per unit. Its overall working capacity is basically unlimited. We are planning to replace SAP with free and always plentiful “vacuum” and prove without a doubt that this is a better solution for adult urinary incontinence care than anything available today. Liquids will be extracted from being close to the skin contact using a small reusable external container which can be anatomically designed to be also portable. The system can be recharged with vacuum as many times as needed without having to remove the diaper from the user. Introducing the new Vacuum-Dry diaper: the diaper that likes to stay dry. The invention relates to the removal of organic liquids from absorbent products such as diapers and sanitary towels and the like; in particular relates to the use of a regulated suction device operated by a “salt valve” or a “liquid sensitive valve” connected to a vacuum container for the removal of organic liquids for hygienic and sanitary uses. The whole system is comprised of four individual components interconnected: 1- A container previously charged with high vacuum (under high negative pressure). 2- A suction tube with flow rate regulation control. 11
  • 12. 3- A “liquid sensitive” starting valve. 4- And a disposable diaper (specially made for this purpose, with no sap). How does it work? The high vacuum container, preferably charged with 15 to 30 Psi of negative pressure (this is free of any cost), is connected to a suction tube located inside the diaper using a liquid sensitive valve in its path. The valve remains closed, avoiding any loss of vacuum from the container until there is enough urine inside the diaper to activate the automatic opening mechanism that opens the valve. Once the valve is opened, the suction generated by the vacuum container collects the liquids in the diaper basically by capillarity and permits the transport of the liquids with the use of a connecting hose (catheter) until they are safely locked inside the container where they remain until discharged. The time delay required to activate the valve as well as the required flow rate can be easily controlled to better adapt to each kind of incontinence (as I will later explain). Once the container is full of liquid, the urine can be discarded into a toilet and the container can be recharged with new vacuum and re used as many times as required until the diaper is disposed. The diaper with the suction device and the liquid sensitive valve can be discarded, but the container is reusable. Let’s take a look at each component: 1- The vacuum container. The container can be made of many materials, like any hard plastic, metal, glass, etc. It just has to be strong enough to stand the high negative pressure without being physically deformed by the vacuum. The simplest form of the container is just an empty bottle with a shut off valve used to open or close the bottle. The same valve can be used to recharge with vacuum using an external manual pump. This way you can have one or more spare bottles already charged with vacuum and use as needed. A more sophisticated design of the container can have a manual piston already integrated to the container; this manual pump can be used to generate the required vacuum by pushing the piston several times with the thumb until the high vacuum is achieved. An even more complete system can have a mechanical pressure indicator (such as a simple spring). The pressure indicator can show in an easy way whether or not the container has any vacuum left and when it has to be recharged (just by looking at the position of the piston, fully extended or retracted). This way you can easy prevent an accidental failure of the system by alerting the user when there is low vacuum in the system. The size of the container can be easily adapted for portability, like when used by mobile incontinent users (for example less than 250 ml), or can be of larger size, like when used by handicapped people in a wheelchair or people in the bed (for example from 400 to 750 ml). A small battery could also be used as an option in order to alert the user with a sound or with a vibration signal when the vacuum is getting low, this could be another way for preventing a malfunction due to low vacuum. 12
  • 13. 2- The suction tube with flow rate control. In its simplest form, the suction tube is just a piece of plastic tube connected to a catheter hose small enough to be inserted comfortably and discreetly deep into the diaper. At the inserted end of the tube, a piece of cotton with an extended length is placed into the tube with pressure. The amount of pressure used and the amount of length of cotton inside the tube can easily be adjusted to control the required flow rate once the system is activated. This flow rate can be adjusted for patients with different kinds of urinary incontinence, for example like those that require a high flow rate in a short time, and those that leak just a few drops per minute but continuously (for example only 1 ml per minute or less). Table 1 shows a correlation between flow rate and cotton length in one particular application. Another way of controlling the flow rate is using a flow control valve or different diameter hoses. The cotton inside the tube prevents the entrance of gas but permits the suction of liquid due to the capillarity flow within the cotton fibers. For this function to operate correctly it is necessary that the cotton fibers are wet or at least semi-wet, if they are dry they will take in air and loose vacuum. This is why the “liquid sensitive” valve is an important key element and the brain of the whole system. 13
  • 14. Length
Cotton
(mm)
 Flow
Rate
(ml/min)
 20
 1.3
 10
 4.3
 
5
 9.3
 2
 13
 1
 18
 Table
1
Flow
rate
as
a
function
of
cotton
 
Length
inside
the
suction
device
 3- “Liquid sensitive” valve. The “liquid sensitive” valve has the function of closing the catheter that connects the vacuum container with the suction tube and keep the connection closed until it detects the presence of liquids inside the diaper. Once this happens, that valve remains open. This function is extremely important as it is the only way to avoid the loss of vacuum while the system is waiting for the 14
  • 15. first urine insult of the user. It can be easily incorporated by a simple mechanical action without the need for batteries or electronic sensors. Here a list of several options available: 1- The use of a “salt valve” operated by a grain of salt that closes the connecting hose using direct mechanical pressure (like an open electrical terminal). When the liquid dissolves the salt after a short delay, the valve opens as there is no more obstruction. 2- The same “salt valve” using a pressure chamber or mechanical spring to assist the opening of the hose once the salt has dissolved. 3- The use of “medicine-like” capsules. After contact with water the capsule softens and the valve is open. The time delay required depends on how thick is the capsule and the number of capsules used. Table 2 shows and example of the correlation between open time and one particular kind of capsule. Samples of liquid sensitive valve (electric terminal and Medicine cap) 15
  • 16. Table 2 Using two different medicine caps to control the start timing of the suction Liquid Sensitive Valve (medicine cap design) integrated with Suction Device 16
  • 17. 4- Disposable Adult Incontinence Diaper: Even when it is possible to use a regular commercial diaper with some minor adaptations, the system works better when the superabsorbent is completely removed from the diaper. The reason is that the SAP is competing against the vacuum and it only makes it more difficult for the vacuum to do its job. When the SAP is removed, the liquid can be easily extracted from the pad without any additional efforts. The best diaper for this job is a diaper with a thick acquisition distribution layer (a good ADL), to keep the skin of the user separated from the absorbent core, and just enough liquid capacity and retention to hold the urine while the liquid sensitive valve is activated by the contact with the urine without any risk of leaking urine out of the diaper. The pad can be made of 100% fluff or it can also be fully synthetic, like air laid, curly fiber, or similar materials. A preferred diaper design will have a pouch like a kangaroo that allows the insertion of the suction control and the “liquid sensitive” valve (sold as a kit) deep into the absorbent core. This way the kit will be in direct contact with the absorbent material and close to the insult. An alternative option is to open a small tongue on the front top sheet, the kit is placed on top of the pad and then the tongue is closed with soft Velcro material. A kit can be designed for every kind of incontinence, with different time delays and different flow rate suctions. At the beginning it may be sold with medical prescription. In the future, once the product is better known, it will be sold over the counter without a prescription. This kit, with an initial estimated manufacturing cost of 3 US cents per unit, will be connected to a vacuum container, one of the many kinds of containers that I have already described. It is important to remember that this container is fully reusable. The expected cost of the container is expected to be from 5 to 15 USD depending on the included options. The new diaper will have about the same manufacturing cost than current commercial diapers because this new diaper does not need any SAP, and the savings obtained from the SAP will probably pay for the kit and the use of a thicker ADL. In addition, because there will be less diapers used every day, the actual cost of diapering will be for sure much less than current practices. A good realistic estimate is that a typical user will spend less than half of the money they spend today. Diaper with suction device KIT inserted into diaper in direct contact with fluff 17
  • 18. It is not only cheaper, it is much better! The new technology uses less resources and it is by far a better solution for the environment and amazingly enough, for the final user too! There are no toxic products required and no additional natural or synthetic resources; in fact the most important component of this technology is NOTHING (yes, free abundant vacuum). It will result in less CO2 emissions and also in less contamination to the landfill. There are many more social and economic benefits; for example, it makes it easier for the nurse or guardian to provide quality care. It also reduces the cost of skin care associated with diaper rash and maceration due to extended lengths in contact with the urine. It improves the quality of life of millions of end user by providing a more comfortable and discreet solution, both in diaper thickness and with regards to odor control. You can almost forget about feeling the cold liquid near the skin every time you seat or apply pressure to a wet diaper. It will be the closest thing to restoring a normal life to an incontinent adult. Draining the container when needed will be almost equivalent to going to the toilet, as anyone else who is continent. This new technology makes an incontinent person feel more like a continent person again. Benchmark of the Vacuum Dry Diaper .vs. Commercial products. Unfortunately I cannot share laboratory results of the new vacuum-dry diaper prototype against some of the best adult incontinence diapers in the world, as this work is currently under way at this time and it was not ready on time for this presentation. In addition we do not have a protocol to use with this new technology. Interesting to note is that while a commercial diaper starts to have performance problems after a secondary or third rewet test, for the new vacuum- dry diaper this issue is less relevant due to the unlimited capacity of the diaper after renewing the vacuum, so we can test 3rd, 4th or 5th rewet if we ever wanted. We believe there are still a lot of things to do to improve the design of a diaper that will be used with this new technology. For example, we suggest using a much thicker ADL to help keep the skin of the user even drier. It is also better to use special zones within the pad designed to move the liquid to a centralized location in the diaper for an easier liquid extraction. One thing we have noted is that the current vacuum-dry prototypes we have tested work better in women than in men. One reason is the larger spread area for the urine in males when compared with females. We have modified the use on men by adapting the “liquid sensitive” valve and the vacuum dry technology to a male “pee cup”, made of a pad that is half open (similar to a long sanitary napkin folded in two). It is designed for the easy placement of the penis and it can be closed with a Velcro tab, all other edges sealed. Instead of a “leg cuff”, a “penis cuff” near the top is used for a good leakage seal at optimal comfort. Although we cannot claim perfection at this time, we have enough evidence to prove that this technology has a promising future and much lower costs; I also believe it will replace many adult urinary products in the near future. How long it will take depends on you. 18
  • 19. A live performance for the many skeptics: Seeing is believing! I know all I have said so far may be difficult for many of you to digest; after all we have been making disposable diapers in a very different way for the last 50 years, the best way we knew. Many of you have invested lots of money in equipment and new technology. Pay attention, if you do not understand the new concepts and pretend that nothing happened in this presentation, you will end up missing the boat. I will do a live demonstration and I will challenge you to come to the front and feel the diapers by yourself and inspect the individual components used. In an industry that seemed almost mature, with only few small insignificant changes, finally a new fresh idea that will change the way we think. Get ready! There is no magic, only a smart fresh idea. This new technology is here to stay; I will make absolutely sure of that! For the next step, you are invited to join us! We are looking for a small group of companies who are willing to take this challenge to the next step and move it from a simple prototype to a new mass merchandise reality. This new patented technology will be a new reality that will improve the quality of life of millions of people all over the world. The first companies showing a firm commitment to join us will have the greater benefits and concessions. I have been in this industry for 25 years; during this time I was responsible for the manufacture of more than 7 billion diapers. I have seen many diaper improvements during this time and have visited diaper factories in many countries in my current job as an industry consultant. I believe this experience has given me a unique global vision of the diaper industry. I strongly believe this is one of the best inventions for the adult diaper incontinence industry ever. You can expect a fair Win-win deal from somebody that understands this industry (by the way, the big W is your company; we are only looking to get a very small “w” in this Win-win relationship). Finally, I would like to challenge anyone who is still not a believer to give me a chance to present this technology to your R&D and Marketing staffs. In these extremely critical financial times, it is about time we get over the “Not Invented Here” syndrome and accept good ideas wherever they come from. It is about time we find ways to stop wasting our precious resources. This is the only diaper providing good answers to all the initial questions. This is the way how urinary incontinence should be treated from now on! I think it is about time that we deliver a better solution to the millions of incontinent people suffering this problem all over the world. It is a small world, Get connected: use my LinkedIn to stay connected and join my Diaper Industry Network group on LinkedIn. 19
  • 20. You can download the videos presented in the conference using these links: http://www.youtube.com/watch?v=eBUDVXhF7oc http://www.youtube.com/watch?v=jsaVHTjFO9Q http://www.youtube.com/watch?v=jLRxOueKxcM http://www.youtube.com/watch?v=7qZreXAEtDQ http://www.youtube.com/watch?v=9aoyd7RbbeI My sincere thanks to the following individuals who provided important feedback and insight in the preparation of this paper: - Andrew Urban (Urban Consultants) - Price Hanna (John Starr) - Ricardo Zambrano (PGI) - Bill Dehaas (Global Market Technologies) - Juan Guadalupe Marcos (Lambi) - Ivan Tava (Mova Marketing) - Pat Gillis (Seattle) - Doctors and Pharmacists from the city of Venice Italy and all people involved. - My brother Eugene and sister Hilda who provided key constructive criticism. - My nephew Eugene who made the very nice animations (Camaleon) - To my wife and kids who helped with each stage of this project. 20