DE102010033356A1 - Breast epithesis, breast orthosis or breast prosthesis for use by breast cancer affected woman, has artificial nipple that swells, bends and falls down, and stimulation unit with electrodes for creating feeling of movements on skin - Google Patents

Abstract

The epithesis, orthosis or prosthesis has an artificial nipple that swells, bends and falls down, and a non-invasive, transcutaneous electronic nerve stimulation unit with individually controllable electrodes for creating feeling of movements on skin of a carrier i.e. woman. A microphone is provided for stimulating acoustic signals, and a wireless receiving/transmitting unit enables selection/updation of parameters. An automatic sequence controller is provided for causing relish feelings during contact of the epithesis, orthosis or prosthesis of the carrier by a partner.

Description

Background and state of the art:

About every 10th woman is confronted with the shocking diagnosis of breast cancer during her lifetime.

In many cases, there is no choice but to amputate the diseased breasts, which is an extreme mental burden, both for the sufferer and for the partner.

While there are operational opportunities to at least partially rebuild a breast surgically, many women are shying away from further surgery, especially since such procedures, which commonly involve the use of silicone oil implants, are considered to be of the highest risk class - it often happens that such implants burst and leak.

In order to give breaststroked women reasonably the feeling of "being a woman", various manufacturers offer so-called "epitheses" - silicone products, which are based on the appearance, "rocking behavior" and the feeling of touch, a female breast as far as possible.

These are in the simplest case simply loosely inserted into the brassiere or (more advantageously) glued to the skin, eg. B. by self-adhesive coatings.

The following patents describe such epitheses (incidentally under the term "breast prosthesis" which does not apply here):
DE 3889462 T2 06.10.1994
DE 19838428 B4 15.09.2005
DE 19838428A1 09.03.2000

But such epitheses are naturally lifeless objects without any sense of touch. The wearer does not really have the feeling that she has a real breast.

It must also be mentioned that such epitheses are not only worn by breast-amputees. They are also often used by women who are dissatisfied with the perceived as too small size of their natural breasts.

Also interested men (transvestites, transgender ...) use such products.

Physically healthy user groups have the advantage that their nerve tissue in the chest area is fully intact, in particular the particularly touch-sensitive nipple. Because even these target groups usually want to have the feeling of having a "real" female breast; If you want to be stroked by the pleasant feelings, you will want real nipples that swell when aroused. But the current state of the art can not fulfill these wishes.

The invention:

The aim of the invention is to realize a breast pithesis or -Orthese which the wearer / the carrier, in addition to the above properties, especially when touched, largely gives the feeling, so to speak, "consist of meat".

That is, a touch of the artificial breast should as much as possible resemble the feeling as if a natural breast were being touched.

For this purpose, no surgical intervention is necessary - the invention is as previously provided with a self-adhesive coating and glued to the skin.

The (as far as given) still intact nerves are stimulated "transcutaneously", thus through the skin surface, which goes so far that in this way even sexual arousal can be brought about.

An almost intangible technical interior captures the touch of the artificial breast, evaluates it and finally stimulates the nerves.

Furthermore, the invention has the property that tender caresses of Kunstbusens stiffens the nipple, which subsides after some time. This process is based on the natural behavior of a female breast and can be triggered as often as desired.

• – Möglichst realitätsnahes Empfinden für Trägerin und Partner.
• – Nahezu keine Beeinträchtigung des „Wippverhaltens”.
• – Innenleben quasi nicht ertastbar, auch nicht bei kräftigerem „Kneten”.
• – Berührsensitiv auf der gesamten Kunstoberfläche.
• – Multi-Touch fähig (mehrere Berührstellen werden gleichzeitig erfasst).
• – Berührsensitiv auch für Gegenstände.
• – Unterscheidung und subjektiv möglichst reale Weitergabe von:
• – Sanftestem Streicheln
• – Drüberstreichen (wie beim Waschen)
• – Stumpfer Druck
• – Kratzen
• – Kneifen
• – Sensoren immun gegen Wippen (keine Fehlmeldung von Berührsignalen).
• – Weitgehend wasserdicht.
• – Pflegeleicht.
• – Keine nennenswerte Alterung bzw. Verschleiß.
• – Gute Hafteigenschaften auf der Haut.
• – Medizinisch unbedenklich (Material, elektrische Parameter).
• – Anschwellen der Brustwarzen schon bei sanftester Stimulation.
• – Anschwellen/Abschwellen naturgetreu beliebig oft auslösbar.
• – Alle Variablen individuell parametrierbar.
• – Akkufüllung hält unter realitätsnahen Bedingungen min. 16 Stunden.

The following list gives an overview of the characteristics of the invention in short keywords:

• - As realistic as possible for the wearer and partner.
• - Almost no impairment of the "rocking behavior".
• - Inner life virtually untouchable, not even with stronger "kneading".
• - Touch sensitive on the entire art surface.
• - Multi-touch capable (several touch points are detected simultaneously).
• - Touch-sensitive also for objects.
• - Distinction and subjectively as real as possible dissemination of:
• - softest stroking
• - Drüberstreichen (as washing)
• - Dull pressure
• - Scratch
• - Pinch
• - Sensors immune to rockers (no false signal from touch signals).
• - largely waterproof.
• - Easy to clean.
• - No significant aging or wear.
• - Good adhesive properties on the skin.
• - Medically safe (material, electrical parameters).
• - Swelling of the nipples even with gentle stimulation.
• - swelling / swelling lifelike as often as possible triggered.
• - All variables can be parameterized individually.
• - Battery filling keeps under realistic conditions min. 16 hours.

• – Auto-Stimulation (sich automatisiert scheinbar „streicheln” lassen).
• – Mehrere Stimulationsprogramme, „von zart bis hart”.
• – Software-Editor zum Erstellen individueller Programme am PC.
• – Integriertes Mikrofon für Stimulation im Takt zur Musik.
• – Fernbedienung.

The following properties, which go beyond the natural behavior of a breast, are also feasible with the invention:

• - Auto-stimulation (seemingly "caressed" automatically).
• - Multiple stimulation programs, "tender to hard".
• - Software editor for creating individual programs on the PC.
• - Integrated microphone for stimulation in time with the music.
• - Remote control.

The list mentions it already: The invention includes electronics, as well as an energy source, in the form of a battery.

• 1) Sensorik (das Erfassen der Berührungen).
• 2) „Aktorik” (die Stimulation der Nerven).
• 3) Das Versteifen der Brustwarze.

For the realization of the invention, the following three problems are relevant, in contrast to conventional breast epitheses, in particular:

• 1) Sensor (detecting the touches).
• 2) "Aktorik" (the stimulation of the nerves).
• 3) Stiffening of the nipple.

1) Sensor technology:

A natural breast is very sensitive to even the softest stroking. In particular, the nipple is extremely sensitive as an erogenous zone.

Much stronger mechanical influences, as z. B. caused by the natural "rocking" of the breast, z. B. when walking, however, are perceived significantly less strong.

In order to take this circumstance into account, the sensors or the evaluation of the sensor signals must be able to reliably differentiate between contacts of the surface with other forces.

Since a breast naturally is very flexible, sometimes quite "kneaded" during sex, a suitable sensor must withstand all these influences without being tactile.

• 1) Erfassung der Berührungen direkt an der Oberfläche der Kunstbrust.
• 2) Erfassung aus Distanz zur Oberfläche, durch weiter innen liegende Technik.

For this purpose, two basic principles are available that are used individually or in combination in the invention:

• 1) Detecting the touches directly on the surface of the artificial breast.
• 2) Detection from distance to the surface, through further internal technology.

Option 1 is in the art u. a. applied in "touch screens".

• a) Berührung der Oberfläche und
• b) Kraftwirkungen innerhalb der Brust beim „Wippen”.

Advantage is the possibility of very reliable distinction between:

• a) touching the surface and
• b) Power effects within the chest during "rocking".

The disadvantage is that such a solution usually requires electrical contacts, which imposes considerable restrictions on the mechanical strength and longevity.

Option 2 works without electrical contacts to the breast surface.

For practical reasons, optical methods are suitable for this purpose, as well as pressure-sensory methods in which pressure sensors (piezoelectric sensors, resistive sensors, capacitive sensors, etc.) mounted inside the breast, as far as possible under the surface, detect force effects and separate them into their force components by means of suitable filtering (Strength, direction vector) to draw conclusions about the type of force.

Since each of these techniques has its own advantages and disadvantages, depending on the shape and size of the artificial breast, the most appropriate technique or technique combination must be selected.

Thus, with very flat breasts, it is easily possible to dispense with sensors directly on the surface or optical processes (by means of image sensors etc.) and to work exclusively with pressure sensors implemented further inside, since the damping of the filling material used in the epitheses / orthoses ( mostly cross-linked silicone gel) can not be particularly strong in flat designs.

In more lush versions, however, when the damping of the abundant Filling material makes it difficult to correctly evaluate by means of deeply placed inside sensors, it may be better to use a kind of touch screen technology that detects touch signals directly on the surface of the artificial breast.

For reasons of longevity and to increase the mechanical strength, in the invention in such cases usually a special, stretchable in all directions, textile fabric is used, which is traversed with electrically conductive fibers and acted below the artificial breast skin in the product becomes.

The patent DE10242785A1 01.04.2004 describes such a yarn, which can be stretched relatively strong without significant loss of conductivity.

With an XY matrix of such fibers, which do not touch each other at rest, it is possible by resistance measurements to locate one or more points of contact spatially exactly when cross-over fibers touch each other.

This technique has the disadvantage that a high number of fibers has to be contacted, whereby nothing should be palpable and that the longevity is subject to certain restrictions.

Instead of resistance measurements, it is also possible to detect measurements of capacitance changes that occur when the surface is touched, because conductors that are insulated from each other generally form a capacitance whose value depends on factors that change significantly on contact (or even mere approximation).

In addition, piezoelectrically active fibers are known today, which can also be used to realize pressure-sensitive, flexible surfaces.

However, resistive as well as capacitive or piezoelectric methods require complex electrical contacts.

For this reason, such methods are usually used only in larger models, where the attenuation of the filling material of the artificial breast makes it difficult to detect or falsify at a greater distance. For the purpose of cost savings u. U. also only in spatially limited regions - meaningfully in the area of the nipple.

A simplified variant uses conductive fibers, which run as a thin strand of the artificial nipple to the electronics inside and are surrounded in the area of the artificial nipple of coal dust. In this way, a sensor is realized in the manner of a carbon microphone, each of the conductive fibers is a separate sensor channel, so that from the force on the nipple directional information can be obtained.

This technique works without textile fabric as a useful carrier material, but also requires at least some electrical contacts.

Optical methods do not have this disadvantage.

A deep inside the artificial breast mounted image sensor, in conjunction with a suitable light source, eg. As infrared LEDs, detected by the substantially transparent filling material, deformations of the surface, wherein an evaluation of the image signals local deformations, when touching the surface of such deformations differs, as z. B. arise when "rocking" of the chest.

Again, such optical methods have the disadvantage that it is difficult to detect the entire breast surface, especially to the edges.

For the above reasons, in the invention, depending on the size, shape and desired properties of the breast, taking into account economic aspects, therefore combinations of said techniques are used.

• – Sensoren an der Oberfläche erfassen präzise den besonders wichtigen Bereich der Brustwarze. Diese Sensoren können resistiver, kapazitiver oder piezoelektrischer Art sein.
• – Optische Sensoren im Inneren erfassen kontaktlos einen größeren Bereich der Brust.
• – Der weniger relevante Randbereich wird von weiter innen liegenden, resistiven, kapazitiven oder piezoelektrischen Sensoren erfasst, wobei die durch Distanz zwischen Sensor und Oberfläche bedingten Ungenauigkeiten in Kauf genommen werden, bzw. durch elektronische Filterung und Interpolierung, im Rahmen des Möglichen, eliminiert werden.

An example of a larger version:

• - Sensors on the surface precisely capture the most important area of the nipple. These sensors can be resistive, capacitive or piezoelectric in nature.
• - Optical sensors inside detect contactlessly a larger area of the chest.
• - The less relevant edge area is detected by sensors located further inside, resistive, capacitive or piezoelectric, taking into account the inaccuracies caused by the distance between the sensor and the surface, or eliminated as far as possible by electronic filtering and interpolation.

The - depending on the individual case so different - sensor signals are evaluated by a microcontroller, processed and finally passed on to the "actuators".

2) "Actors":

• 2.1) Modulierte, transkutane Reizströme
• 2.2) „Mikrovibrationen”
• 2.3) Kinetische Einflussnahme

Depending on the needs, three different techniques are used to stimulate the nerves, either individually or (mostly) in combination, depending on individual circumstances:

• 2.1) Modulated transcutaneous stimulation currents
• 2.2) "Microvibrations"
• 2.3) Kinetic influence

2.1) Modulated transcutaneous stimulation currents:

Commercially available Transcutaneous Electronic Nerve Stimulation (TENS) devices typically employ 1 to 4 electrode pairs and relatively large area electrodes.

Such devices, originally developed for medical use, are often used today for sexual stimulation.

However, due to the small number of electrodes, their large surface area and the usual electrical parameters, it is not possible to stimulate exactly single nerves in space, thus imitating impressions such as gentle strokes over the skin.

Furthermore, it is virtually impossible to produce "very pleasant" sensations with commercially available TENS devices, since the currents generated as a whole rather than "stabbing" perceived nerve irritation.

On the other hand, the invention described here uses a high number of rather small electrodes, which are in electrical contact with the natural skin.

Due to the small electrode areas, compared to standard TENS devices, around 1000 times lower current levels are sufficient for the desired result. Therefore, in the area of the heart area no danger to the user is to be feared. The currents in the invention move in the range of less microamps, but, for the purpose of individual adaptation, for. B. in damaged nerves, also be raised significantly, up to the double-digit mA range.

In order to be able to replicate striking strokes of the breast spatially exactly and forward these signals spatially corresponding to the natural nerve tissue, the invention is able to individually control each individual electrode on the skin - in all parameters.

"All parameters" here means not only the current or the width of the pulses, but the complete shape of each electrical signal at each electrode, can be individually defined exactly.

An electronic circuit with a microcontroller and D / A converters causes the formation of individual electrical signals, according to the situation, with high clock frequency and current control of each channel a very accurate dosage of the respective amount of energy is achieved.

To illustrate, a simple example:
If a row of electrodes is driven in the style of a "running light", this already gives the impression of a sweeping movement along the line or shape formed by the electrodes.

But for a close-to-reality experience of touches, simply driving a number of electrodes is not enough.

For optimal sensation, the shape of the electrical signals and the amount of energy delivered per time is of utmost importance.

Thus, permanently applied DC currents, as well as relatively slow (quasi-unipolar) waveforms are usually perceived as "pungent".

Since the respective sensation varies greatly from person to person and is also dependent on other factors (contact resistance, given by skin moisture, etc.), an individual adaptation of the individual parameters and an automatic readjustment is necessary.

The required parameters are stored internally, z. In an EEPROM or other suitable memory technology, and may be modified at any time so as to ensure optimal sensing.

For individual shaping of the electrical signals, the invention has per electrode as mentioned above each a digital-to-analog converter and a current control circuit.

A dual power supply ensures that the generated signal forms can assume any polarity.

To illustrate, imagine a single body hair, which is swept over very gently with your finger.

• 1) Das Haar wird berührt.
• 2) Der Finger streicht nun über das Haar und versetzt dieses in Schwingungen.
• 3) Am Ende „schnappt” das Haar zurück und „federt” dabei etwas nach.

This process includes three sub-aspects:

• 1) The hair is touched.
• 2) The finger now strokes the hair and puts it into vibration.
• 3) At the end, the hair "snaps" back and "springs" a bit.

In particular, point three is incidentally considered to be particularly pleasurable.

If one imagines that said hair is a sensor and records its signal, a complex signal shape would result.

Much more complex than could be simulated by simple, "rectangular" control in the style of on / off / on / off or by triangular signals ....

The invention is now able to replicate even such complex waveforms for each one of the several dozens of electrodes covering almost the entire natural skin surface.

Which signal forms must be generated in detail, "decides" a microcontroller, based on acquired sensor data, taking into account the internally stored, individually adjustable parameters.

As an alternative to the complex, analogue current control of D / A converted values, with lower-cost versions, a pulse-width-modulated technology can also be used, with a unipolar power supply.

Since the energy levels required for targeted nerve stimulation are very low and must be precisely metered, the PWM frequency must be correspondingly high (up to the three-digit MHz range).

In order to work with unipolar power supply, no common ground electrode is used in the case, but those electrodes which are spatially closest to the respective target electrode, are switched to the respective opposite potential. The current is distributed in such a way that the highest current density in the region of the target electrode is achieved.

In addition, in order to keep the stimuli in the region of the counterelectrodes below the stimulus threshold, the counterelectrodes can also be actuated with a time delay, such that the current supplied flows through the target electrode over a longer time than through the individual counterelectrodes.

The advantage of this PWM technology is the hardware considerably realizable feasibility, whereas the disadvantage is that the exact dosage of energy is more difficult, since never all the electrodes can be controlled simultaneously, since the surrounding electrodes are temporarily "abused" as counterelectrodes to to achieve this way any flow directions. Consequently, the digital computational effort is higher, which makes the software especially complex.

In both cases, whether with analog current control or with PWM technology, a supply voltage of up to 40 V is used. For PWM as mentioned, however, only unipolar.

The invention therefore includes a circuit for increasing the battery voltage to up to 40 V.

In the case of PWM, this supply voltage can be arbitrarily lowered by the electronics in order, in addition to the metering of the energy by means of pulse width modulation, to also be able to influence the parameter of the driving voltage.

Since, in the case of PWM, if necessary, only one electrode is active (while the surrounding electrodes represent only the opposite pole at this time), the current flow through the target electrode can be accurately detected by measuring the total current, so that in this way, By adjusting the PWM and / or driving voltage, a regulation of the amount of energy delivered into the skin at the respective location is possible.

2.2) Microvibrations:

If a finger or an object brushes over a surface, even over a skin surface, friction will cause vibrations there.

In some cases, it may be useful, instead of transcutaneous electronic nerve stimulation - or as a supplement to this - to forward such microvibrations to healthy skin.

Various actuators are suitable, for. B. electromagnetic vibrators.

In particular, for reasons of space and because usually only very fine vibrations are needed, piezoelectric crystals are used in the invention, but in a way that is also capable of producing stronger vibrations, with greater amplitude, than it is with individual Piezos would be possible.

For this purpose, no single piezos are used, but usually at least two or more pieces, individually controlled in a way that a hard object, which the Piezos touched simultaneously, a feed force is applied.

For clarity, a simple example:

If two piezos are mounted on a horizontal surface, which expand in the vertical direction with an electrical signal, a horizontal feed on a hard object, which touches both piezos, is produced with individual, mutually phase-shifted activation.

Example for the control of two piezos, with quadrature signals phase-shifted by 90 degrees:

• 01 (left piezo off, right piezo on)
• 11 (both piezos on)
• 10 (left piezo off, right piezo on)
• 00 (both piezos off)

Through any repetition of this pattern, in a frequency which corresponds to the resonant frequency of the mechanical total system, an arbitrary feed in a horizontal direction can be effected in this way.

If the phase position is reversed, the feed direction also reverses.

By permanently repeated polarity reversal of the phase position of both signals, a horizontal vibration can now be effected, with an amplitude which depends on how often the sequence mentioned in the example is repeated before the phase position is reversed.

This technique is therefore not really about linear feeds, but rather an amplification of the amplitude of the piezo-vibrations, as well as to reduce these frequencies to a desired level, since the piezo's are operated with their (clearly located in the ultrasonic range) resonant frequency.

With a corresponding structure and suitable control can be generated in this way on the skin noticeable vibrations with (in the relevant, noticeable range) arbitrary fundamental frequency and amplitude, which far exceeds the possible, very minimal modulation amplitude of a single piezo and is independent of the Uncertainly high natural resonance frequency of the individual piezos.

This technique is not exclusive, but in particular, suitable for stimulating the natural nipple and is used on some models.

2.3) Kinetic influence:

Although in many cases, transcutaneous electronic nerve stimulation is capable of inducing feelings such as those arising from vigorous skin contact, or even "kneading" the breast, it may be useful to actually exert "greater" mechanical forces on the healthy skin.

In particular, to stimulate a healthy nipple, it may be useful to move them mechanically.

Also for this task different techniques are basically applicable, such. B. electromechanical actuators.

In addition to the already described possibility to generate feed forces by means of piezoelectric actuators, another variant is usefully applicable and is used in the invention as needed: Memory Metal Alloy, z. Nitinol / Flexinol).

"When needed" means that the optimal technique always depends on the respective user, because especially in cases of mastectomy, with different impairment of the nervous tissue, the most appropriate technique should be used individually.

It is therefore foreseeable that the invention will be used in several hundred model variants with different technology combinations.

By means of so-called "shape memory alloys", such as nitinol / flexinol, it is possible to realize extremely powerful actuators, based on the total weight.

Nitinol wires on reaching the activation temperature enable a reduction in length of the order of a few percent, while being able to convert relatively considerable mechanical forces.

Example: A Nitinol / Flexinol current-carrying wire with a diameter of only 25 micrometers and a transformation temperature of e.g. B. 70 degrees Celsius, reached at an ambient temperature of 25 degrees Celsius its activation temperature already at a current flow of about 20 mA and is able to exert a tensile force of about 0.07 N - a force comparable to the finger pressure on a light switch etc.

By connecting adhesive dots on the skin with nitinol wire of suitable diameter, thus can be transmitted to the skin force effects, such as. B. arise when squeezing the breast tissue.

By approximately spoke-like arrangement of Nitinoldrähten, placed on the nipple platelets in both horizontal dimensions can be moved, at least partially rotate, and slightly raise and lower.

3) Stiffening of the nipple:

The stiffening of the artificial nipple, in sexual stimulation, is done by increasing the internal pressure.

For this purpose, a suitable, usually liquid medium is transported into the nipple.

In low-cost variants of the invention, a principle is used, which does not require electronics and is roughly comparable to the principle of a pipette in which air mechanically displaced from the artificial nipple and a liquid medium is sucked in, with a not completely tight valve rapid backflow of the medium for a while prevented.

Since the valve is deliberately not made completely tight, there is a swelling with time by itself.

Disadvantage of this simple technique is that the nipple must be pressed repeatedly and relatively strong in order to bring about the mentioned effect.

For higher-quality versions, therefore, an electrically driven micropump is used, which, after evaluation of the signals of the touch sensors, pumps the medium into the nipple, or pumps it out there again.

This is a reservoir inside the invention, which is connected via a thin, barely palpable hose with the artificial nipple.

In order to survive any deformation of the breast unscathed, this tube is of some flexibility and slightly longer than required at rest.

Since the pump is to work absolutely inaudibly and without noticeable vibrations, a nitinol wire is generally used in the invention, which shortens when there is a flow of current and thereby presses a movable plate against the reservoir so that the medium contained therein passes through the hose into the reservoir Nipple is pressed, which increases its internal pressure, so that the nipple swells and stiffened.

The principle is similar to a bellows, which is compressed by the shortening wire.

The tube is also surrounded in some models by electrically conductive fibers that connect the located on the nipple touch sensors with the electronics, which is located near the reservoir inside the chest.

As an alternative to the use of nitinol wire, the desired effect can also be achieved with piezos by, as described above, a feed is applied to a movable part, which is thereby pressed against the reservoir so that the desired pressure is achieved.

Mechanical construction of the invention

So that the electronics are virtually untouchable, this is in a flat, dome-shaped housing, which is mounted almost directly on the natural skin of the wearer and is significantly smaller than the entire artificial breast.

This dome contains, in addition to the electronics, the reservoir for the medium for stiffening the artificial nipple.

From the "roof" of the dome leads the mentioned, thin tube to the nipple, which is wrapped in some model variants with conductive fibers, which allow the contact of the sensors on the nipple.

The skin-like surface of the invention is usually made of PU film, as usual in previous breastthroplasty.

As usual, the breast is usually filled with a gel of cross-linked silicone.

Due to the dome shape of the case and its flatness, as well as the still abundant silicone gel as filling material, the technical interior of the breast is virtually untouchable.

The inner dome housing is, depending on the design, provided on the surface with pressure sensors of resistive, capacitive or piezoelectric nature, which pressure on the chest, through the gel-like filling material, detect and dissolve reasonably spatially, a microcontroller interpolates the signals and in this way the apparent resolution increases.

In order to improve the signal quality and the spatial resolution, a sieve-like structure can span the sensors on the dome housing like a second dome, whereby lateral force components on the sensors are largely damped and almost only one relative to the respective sensor relative, vertical force component can reach the sensor.

For clarity, imagine a dome-shaped curved, provided with numerous holes plastic plate under which pressure sensors are located. The whole assembly is embedded in silicone gel, which is exposed to mechanical forces.

The thicker the perforated material is and the thinner the bore diameter relative to the material thickness, the more lateral force components are damped. Only vertical forces reach the sensors below the holes.

Instead of the pressure sensors on the dome surface - or as a supplement to these - can be mounted on the dome surface and optical sensors plus light sources, or optical "windows", for internally mounted sensors and light sources.

These detect, by the largely transparent filling material (silicone gel) through, from inside her deformities on the breast surface.

The underside of the dome lies on the natural skin of the wearer, or is glued to it.

The entire underside of the invention, so that surface which is glued to the skin, is traversed by dozens of electrical traces, which end in electrodes that serve to direct the TENS signals targeted to defined areas of the skin, so as spatially possible to ensure exact stimulation of the nerves.

For this purpose, medically acceptable, adhesive coatings are available, such as those used in the electrodes of commercially available TENS devices.

Furthermore, electrically conductive silicones are now available on the market, even with self-adhesive properties.

A special position is occupied by the area of the natural nipple.

Although lead electrodes to the edge of the nipple, but this itself is free, so they - if desired, depending on the model - by appropriate actuators in addition to the electrical stimulation also can be moved mechanically.

It moves a contact plate, which touches the nipple slightly, in all three dimensions, so also raising / lowering is possible.

The movement of the contact plate can in principle be effected electromagnetically, or piezoelectrically, or by nitinol wires, which are arranged approximately in the manner of spokes of a bicycle.

By shifting the points of attack of the nitinol wires to the contact plate, tangent to its center, in addition to any shifts and increases / decreases of the plate, even slight rotational movements can be realized.

The contact plate also represents itself an electrode, which is connected to a TENS output, to be able to feed the stimulation currents in the uppermost point of the nipple, with each of the surrounding electrodes can be selectively switched as an opposite pole to in this way, pure electrically, to evoke the feeling of lateral nipple touch, including "pinching".

Since the use of nitinol wire - despite all the advantages - is technically extremely difficult and only makes sense in mass production (machine production), for models with a lower number of pieces alternatively a cheaper technology can be used, in which the contact plate for the nipple is moved by Piezos.

The rough principle of how to achieve feed in this way has already been described above.

By a two-dimensional arrangement of a plurality of piezos, with individual control of these, a feed force in any two-dimensional direction can be exercised. Even complete rotations are possible, unlike nitinol wire designs as actuators.

Disadvantage of the use of Piezos is the risk that arise during the feed unwanted, audible vibrations. Furthermore, it requires additional effort to move the contact plate in the third dimension, so this raise / lower.

In addition, it must be ensured that all piezos touch the (necessarily rigid) contact plate.

For the latter reason therefore usually a flexible circuit board is used as a carrier for the piezo, which is pressed at several points against the contact plate.

For this purpose, the contact pad may comprise a core of magnetic material, e.g. B. iron sheet or ferrite dust, wherein behind the circuit board with the piezo are mounted several small magnets, so that the piezos are thereby pressed against the platelets and the platelets requires no further mechanical fixation.

Since the moving contact plate simultaneously acts as an electrode for a TENS channel, it is conductively coated on the side facing the natural nipple, through-contacted and connected via sliding contacts with the TENS channel. It must be ensured that the plate can not cause a short circuit on the piezo - so the sliding contacts must be placed only outside the zone with the piezo and the movement of the plate must be mechanically limited accordingly that at no time an electrically conductive area a piezo can touch.

At the open point of the natural nipple the ingress of moisture, eg. As to prevent sweat, the actual contact plate can also be moved magnetically, through a, waterproof plastic layer.

The moving through Piezos or Nitinoldraht slide transmits its movement magnetically, through the waterproof plastic layer through, on the actual contact plate.

Alternatively, to achieve watertightness, the contact pad can also be connected to the edge with a very extensible "film" (eg made of latex), which in turn is glued to the unmoved underside of the artificial breast.

Disadvantage over magnetic movement is that the bonding with the stretchable latex o. Ä. No full rotational movements can be realized.

Inductive methods are available for charging the built-in rechargeable battery, which however requires the use of a special charging station and is complicated from the standpoint of electromagnetic compatibility (EMC). Alternatively, the battery can be charged via the contact points that are usually glued to the skin. To exclude a reverse polarity, therefore, the invention includes a bridge rectifier. In this charging technique, only a commercial plug-in power supply is required, with a special contact surface which is pressed onto selected, marked electrodes and adheres there by the self-adhesive properties of the skin electrodes, with two pairs of small magnets additionally prevent unwanted detachment. The electrodes used for charging the battery are, in contrast to the other skin electrodes, designed to be particularly low-impedance.

To charge the battery, the invention must be removed from the skin.

Additional features:

Software updates, parameterization

To change the parameters (TENS, stiffening of the artificial nipple, movement of the natural nipple) and to import new software, wireless technology can be used, or the use of a low-cost infrared receiver, taking advantage of the far infrared transparency of the artificial breast.

To change parameters or to import new software, the invention does not have to be detached from the skin.

The data transmission is bidirectional possible; Thus, the invention includes not only a receiving unit but also a transmitting unit (radio technology or infrared). In this way, parameters or a serial number can be read out in order to ensure that only the software suitable for the respective model is imported.

Car stimulation

By selecting an appropriate program, it is possible to trigger the stimulation independently of the artifical's touch.

A program sequence simulates selectable "touching or stroking sequences", which then run automatically and can be passively enjoyed without further action.

Stimulation by acoustic signals

More luxurious variants of the invention additionally include a microphone to provide stimulation in time with the music. The filling material of the artificial breast automatically dampens the unrelevant, higher frequencies.

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• DE 3889462 T2 [0006]
• DE 19838428 B4 [0006]
• DE 19838428 A1 [0006]

Claims (8)

Breast epithesis or breast orthosis or breast prosthesis with the property to make touches of the artificial breast for the wearer / wearer by active technical measures palpable. Breast epithesis or breast orthosis or breast prosthesis with the property that the artificial nipple can swell when needed and stiffen, and can swell. The use of non-invasive, transcutaneous electronic nerve stimulation with high spatial resolution through a high number (more than 10) individually controllable electrodes, in order to create the feeling of stroking movements on the skin. TENS stimulation currents with completely arbitrary waveforms, through the use of D / A conversion and regulation of the amount of energy delivered. Stimulation of the natural nipple by technical means, by direct movement of the nipple in all spatial degrees of freedom, or indirectly, by "swiping" or turning or lifting / lowering an electrically driven object that touches the nipple. Equipment of a breast epithesis or breast orthosis or breast prosthesis with wireless reception / transmission technology, for importing new software or reading / updating parameters, without having to remove the artificial breast. Equipment of a chest epithesis or breast orthosis or breast prosthesis with a microphone, for the purpose of stimulation by acoustic signals. Use of "auto-stimulation" in connection with a chest epithesis or breast prosthesis by automatic sequencing, without further interactions, to produce pleasurable feelings, such as when touched by a partner.