EP2142255A2

EP2142255A2 - Covering and sleeve

Info

Publication number: EP2142255A2
Application number: EP08748764A
Authority: EP
Inventors: Robert Simmoteit; Detlef Gorski; Manfred Helbig
Original assignee: 3mach GmbH
Current assignee: 3mach GmbH
Priority date: 2007-05-03
Filing date: 2008-04-19
Publication date: 2010-01-13
Also published as: WO2008135011A3; WO2008135011A2; DE112008001856A5; WO2008135011A4; DE102007020726A1

Abstract

The invention relates to a covering, sleeve and sheath consisting of bacterial cellulose and to the use thereof. When used in conjunction with medical equipment that emits high-energy rays and sound waves, the invention permits the development of existing therapeutic and diagnostic methods or enhances the application options for said methods. The invention can be used in cosmetic, medical, diagnostic and pharmaceutical methods. The coverings, sleeves and sheaths consisting of a fibre cross-linked hydrated layer are preferably used in or according to medical and commercial treatment methods, to transfer substances and to transfer high-energy rays or waves, or to protect against said rays or waves. The re-usability of the coverings, sleeves and sheaths, even when incorporated into devices, permits both economic and material savings to be made.

Description

Overlay and case

Field of the invention

The present invention relates to a support, casing or sheath and their use düng in conjunction with medical devices and a device for transmitting sound. The invention finds application in cosmetic, medical, pharmaceutical and technical processes, preferably in the medical and cosmetic treatment of outer tissue layers.

Background of the invention

The skin is responsible for the regulation of the water balance and serves as a barrier and protective layer against external influences. In order to be able to penetrate deeper tissue regions from the outside, a number of medical procedures have been developed. These methods are used to kill cancer cells, to stimulate tissue cells or to increase the penetration of drugs. Other methods use sound sources to stimulate internal healing processes or for tissue analysis. Such a method and device is described in DE 692 146 72 T2 for the emission of sound waves. Here, thermal effects and gravitational effects are generated in the tissue. EP 1364 624 A1 uses a gel pad made of polyacylamides in order to improve the laser treatment. In the known methods, energy is supplied to the biological tissue via the skin in the form of electromagnetic fields, light, ionizing radiation or ultrasound waves. Difficulties always occur when the protective layer of the skin has already been damaged or allergic reactions occur.

To penetrate deeper tissue layers, z. As water-filtered infrared A-rays (wIRA) or unfiltered infrared light used. As described in DE 101 16 763 C1, the radiation of a halogen lamp is filtered by a special Hydroküvette, which takes out the skin-loading radiation components. It comes here to an increased depth effect with known main effects of the irradiated tissues, such as a relaxation of the muscles, anti-inflammatory and pain relief.

Other methods use ultrasound to make drugs more active in the skin or hair or to stimulate tissue regeneration by pulsed ultrasound. In order to transmit the sound into the tissue, a coupling substance is needed. As a rule, substances are used, e.g. Aquasonic® or other commercially available ultrasound gels, for coupling. These gels are necessary for the ultrasound signal to be transmitted. DE 100 56 062 A1 describes a treatment method for hair in which active ingredients are introduced into the hair with the aid of ultrasound and with a temperature increase. Also known are hydrogel flow paths such as SonarAid, which are used in ultrasound diagnostics of inaccessible places.

It is also known from the prior art that ultrasound medicaments can be incorporated in creams into deeper tissue regions. The method is called ultrasonophoresis. Basically, due to the sound vibrations, especially at higher dosage and a continuous application, there is a warming especially at the boundary layers. This temperature increase of about 40 - 45 ⁰ C improves the extensibility of the collagen tissue (scars, tendons, ligaments).

A disadvantage is in particular that are used in the current ultrasound treatments gel pad and lead lines of artificial materials and the fast through - -

Pressure from outside be destroyed. The use of commercially available gels, on the other hand, is unsuitable for wounds and in inaccessible areas, such as on the eye, in tight skin folds or in the vagina. The known methods have the serious disadvantage that no controllable material exchange takes place in the immediate environment of the skin or in the case of a wound sufficient sterility can not be ensured. Of particular disadvantage is that the energy beams or ultrasonic waves impinge directly on the skin and it already comes here to a skin and tissue damage. For treatments with high-energy rays or sound waves that last for several weeks, it is known that the ability to regenerate the skin and the inner tissue can not only be impaired, but even completely destroyed. Such tissue defects lead to difficult-to-heal wounds or severe scarring of the treated tissue regions. In the latter case, activated fibroblasts produce too much collagen. The disadvantage is that medical devices that emit energy beams or sound waves lead to complications and side effects that affect the quality of life of patients. These include skin pigmentation, dandruff, soft tissue edema, radiodermatitis, eczema, just to name a few.

The described disadvantages of the skin and tissue treatments are transferable to other medical, pharmaceutical and cosmetic fields as well as to biological and technical fields.

Summary of the invention

The object of the invention relates primarily to a support and casing or a Ummante- ment for the transmission of sound waves and secondarily also a mass transfer in conjunction with high-energy radiation or sound waves. Furthermore, the invention makes it possible to further develop existing therapeutic and diagnostic methods and improves or expands the possibilities for using these methods. The reprocessing of the pads or casings makes an economical and material-saving use possible. The pads, sheaths and sheaths are used in combination with medical devices and after medical and technical treatment procedures. The use of a hydro tissue in the area of medical irradiation and ultrasound methods, the introduction of pharmaceutical substances and the cosmetic treatment make them safer for humans and additionally permit a transfer of the substance before and after the treatment. In particular, a substance transfer and mass transfer via the skin may be assisted, for example with the aim of see how to activate regeneration processes of the skin and internal tissues. The invention can be used particularly advantageously in the field of ultrasound diagnostics and ultrasound treatment, since the invention expands the use of this technology and, in so doing, the economic use and hygiene of the treatment is improved.

This object is achieved by a support or shell according to claim 1 and by a device according to claim 16. The dependent claims relate to advantageous embodiments of the invention.

It has surprisingly been discovered that a close-fitting and absorbent hydrous tissue of bacterial cellulose having a smooth surface and a high water or liquid content, the transmission of radiation, light and sound waves or substances, in particular by a high mobile water content in a network of thin Fibers or with a fiber-crosslinked hydro layer, favors. Investigations were conducted with a bacterial cellulose fiber network and found that the material transmits ultrasonic waves and enables ultrasound diagnostics. Thus, the material offers a useful alternative to the ultrasound gel.

The object is preferably achieved by a support, casing and sheath in the field of medical, pharmaceutical, cosmetic and technical applications, characterized in that it consists of a hydro tissue made of bacterial cellulose fibers or of a fiber composite material and with a water or aqueous solution fraction of the hydro tissue forming at least one own aqueous film or a thin aqueous layer on or between material surfaces for coupling sound waves and in conjunction with the remaining solution fraction in the hydro tissue provides a transmission medium for sound waves or decelerates radiation, scatters or filters out.

The pads and sheaths are defined as a sheet-like or shaped or tubular material layer which can be used in combination with a probe, a catheter, a holder, a medical component or alone. By the mobile water fraction is meant an extrudable contiguous aqueous portion which can be extruded and / or mechanically agitated from the fine mesh fine fiber network of bacterial cellulose fibers or a composite of these fibers with microfibers or gel bodies of another fabric. The material referred to as Hydrogewebe is defined as fibrous material or substance that is technically or biologically produced and contains a high aqueous content. This also includes fleece-like materials. Fiber composite material, do not consist of a material compound fibrous materials or may also contain several different fibrous materials.

It has unexpectedly been found that straight bacterial cellulose nonwoven webs form a coherent water layer and film of water, which are particularly well suited to the transmission of sound waves and scattering, and to water film

Filtering of rays are suitable. By contact with a skin or a tissue or by slight pressure from the outside or from above, a water film of a few μm up to the nm range forms by itself. This film is in contact with the inner water layer and thus represents a suitable medium for the coupling of sound waves and the scattering and filtering of radiation.

It has been found that the invention can be applied in the form of a dressing or a wrapper to all bacterial celluloses. An advantage is z. B., if a mobile water content or liquid content of at least 60 wt.% Is present. In particular, the formation of its own ever rebuilding water film improves the coupling of ultrasound. This property of the hydro tissue has the advantage over known gel pads or gels that the ultrasonic probe slides particularly well on the overlay or in conjunction with a sleeve, without losing the coupling contact. In this case, no high contact pressure is required from above. Accordingly, this applies if the hydro tissue completely or only partially covers or envelops the ultrasound probe. Here is a water film, z. B. on the skin, and thus supports the sliding. A coherent water layer of thicknesses of z. B. 2 - 10 mm in the hydro tissue forms a suitable forward and scattering distance or a filter section for high-energy radiation or a coupling medium for sound waves. Already layer thicknesses in the hydro tissue between 0.2 - 2 mm, allow the coupling of sound waves. Greater thicknesses of up to 20 mm and more are more suitable for the therapeutic application of high-energy radiation or for targeted coupling of highly focused ultrasound (FUS).

It has been found that in the novel use particularly flexible and absorbent Hydrogewebe on uneven ground have advantages over conventional ultrasound gels in the ultrasonic imaging. For example, studies in humans have shown that the image quality in echocardigraphy with a bacterial cellulose support as a transfer medium compared to gel significantly improved (Table 1). - -

Table 1. Image quality of thoracic echocardigraphy

(IQ = image quality, 1 very good, 2 = good, 3 = bad) BC = Synthesized bacterial cellulose

The above Table 1 shows that the ultrasound image in the thorax region with an edition of synthesized bacterial cellulose is improved by approximately 20% and this even at a lower contact pressure than with ultrasound gel.

Preferably, the hydro tissue has a tissue content of bacterial cellulose fibers between 60-100%. The fact that this proportion is distributed uniformly and reticulated in the material, the peculiarities of the bacterial cellulose arise. Depending on its nature and ingredients, this material naturally possesses or separates liquid or liquid molecules on its surface. A conventional sponge does not have these properties but has partitions or parting surfaces. The proportion by weight of water or of aqueous solution in the bacterial cellulose can be up to 99% and is held firmly in the first place by physical forces and / or by hydrogen bonds, without dripping from the fabric by itself.

It has been shown that bacterial cellulose with a smooth surface in the nm range and a continuous cross-linked structure is particularly well suited for ultrasound transmission on uneven surfaces, because the bacterial cellulose sucks on a biological surface without technical assistance and forms a contact layer. The use is more hygienic compared to known ultrasound gels. The water or the liquid contained in the bacterial cellulose is not bound as in a gel. The layer or envelope made of bacterial cellulose with layer thicknesses of 0.2 - 20 mm behaves like a stable layer of water, without which it can flow apart. This water layer serves as a kind of preliminary route for rays and waves for transmission to the skin, tissue or other material. By z. B. pressing of the ultrasound head, water or liquid is forced out of the bacterial cellulose and it forms a thin aqueous film, at least on the smooth cellulose surface. In this case, aqueous medium is displaced to the outside and depending on the pressure from above, a direct contact with the inner movable and herauspressbaren water or solvent fraction is produced. The deformable structure of the hydro tissue additionally ensures that the shape of the ultrasound head can nestle optimally. The direct contact with the movable aqueous content also improves the location Materialtransp ^', z. B. in the material or out of this. Since the release of water can also be caused by evaporation, it comes in addition to an effective cooling of the skin, without this dries out.

It has been found that a bacterial cellulose with a high water content of over 70% by weight with a smooth surface not only allows the formation of a separate water film for ultrasonic coupling, but also an effective, rapid evaporation and thus a mass transfer with the environment. However, gels or highly cross-linked hydrogel overlays do not have these properties. Our observations prove, however, that it is precisely this water mobility in the bacterial cellulose tissue, which consists of the finest fiber networks, not only provides advantages for the coupling of ultrasound, but also changed the effect of high-energy rays meaningful. The preferred bacterial cellulose has a DPw value between 4000 to 9000 (degree of polymerization), wherein the synthesis direction preferably proceeds in the plane. The soft surface with a surface roughness in the nm range allows the smallest unevenness to be imaged by another surface. However, in order to use the material, especially in the medical field, longer bacterial cellulose molecular chains, a continuous hydronic network and a smooth surface are advantageous. For hygienic reasons, the material may contain alcoholic or other antiseptic solutions. Since the material forms a sterile barrier, it is possible to apply the ultrasound over a wound area or via an internal organ. It is particularly advantageous that such conditions can be used to cover the surgical field or as organ covers. In this case, the surgical field can be observed with ultrasound diagnostics via the support in the immediate vicinity and without gel. In particular, since the pads can be made in different thicknesses and shapes, here the ultrasonic probe can sit flat, although the substrate deformations, z. B. elevations or depressions possesses. The sound signal is thus forwarded particularly well compared to gel. What is important for the ultrasound, z. As a smooth flat surface on uneven ground, is also important for the introduction of high-energy radiation. The treatment procedure in deeper tissue regions can thus be optimally adjusted and standardized.

According to the invention, the hydro tissue or hydro tissue according to the invention find similar materials with the property that these fluids can precipitate, preferably in ultrasound diagnostics (echo pulse method) or in ultrasound treatment such that an ultrasound head is connected here is used with a support or a wrapper or enclosure for coupling ultrasound. The ultrasound heads can be placed without gel on the hydro tissue and through the soft, moist and smooth surface, the sound is transmitted to the skin or a biological tissue. The hydro fabric also forms on uneven surfaces and supports the application in that aqueous molecules can be transported in and out of the material and thus a close contact without air entrapment with biological surfaces is produced. In particular, in the case of flat surfaces, a defined ultrasound transmission layer thickness can be produced from hydro tissue despite the movement of the ultrasound head, which is advantageous in the echo-pulse method. Alternatively, the hydro tissue may be changeably connected to a holder with an ultrasound probe. In the development of the invention, it is also conceivable that other materials exude the liquid and have only a small proportion of solids, such. As soft and pore-containing substances that can store liquid and are suitable for the transmission of ultrasound. Collagenous tissue or hydratable cellulosic sheets of native cellulose are such substances. Also conceivable would be silicones, ie plastics with similar properties.

According to the invention it has also been found that the overlay in an infrared light treatment behaves like a water filter. In this case, the bacterial cellulose is on the skin to be irradiated. Depending on the thickness of the overlay, some of the damaging radiation is filtered out, at the same time the relevant tissue areas are cooled and even a temperature-driven mass transfer is made possible. The inventive requirement can also be used in the field of radiological radiotherapy (eg gamma irradiation) for generating stray radiation and used to combat skin cancer. Stray radiation is actually undesirable in deeper tissue. Alternatively, the material could be usefully used in intensity modulated radiation therapy (IMRT). In the case of skin treatment, it may be desirable that the intensity of the radiation, e.g. As the ionizing radiation, can be adjusted at the site of action and beyond substances are additionally exchanged with the environment or with the tissue. It goes without saying that the hydraulic material is also used in the field of wet wound care. The special properties of the cooling coupled with a mass transfer allows that z. B. the treatment of a thorax irradiated after the irradiation is continued. The aim is that substances that are produced during cell death and activated tissue cells are removed from the upper tissue or upper skin layers or thinned out here.

According to the further aspect of the invention, the hydro tissue replaces the usual ultrasound gel as a coupling medium or a transfer medium as a cover or as a support for ultrasound probes. The advantage is that the material as a protective cover in the form of a hollow body or as a kind of protective cap envelops the probe and flexes even on uneven surfaces and sucks, thereby additionally displace the air between the interfaces. The fact that wet contact surfaces or a liquid film is present, the sound can be optimally transmitted. Through this protective cover, it is possible that the ultrasound probe in inaccessible places in the body, such. B. in the vagina, can be introduced. Another area of application is the eyeball. Here, for example, a support from the hydro tissue is used. Alternatively, the material can wrap extremities such as fingers or toes entirely or only in the front part in order to protect them or treat them safely. This also applies to other parts of the body. Application of high-frequency probes (up to 50 MHz), but also pulsed frequencies of different areas can be combined with the hydro tissue.

In accordance with the purpose of the invention, it has been found that, in particular, increased heat energy generated in a biological tissue by the treatment leads to an increased substance transfer. At the same time, the tissue or the skin is protected from excessive energy input. The high solution and water content, which in a suitable case is more than 90% by weight in the hydro tissue, is a prerequisite for enabling said functions in combination with ionizing radiation, laser light or sound waves during or after the treatment of a biological material. In this case, the support or the casing may contain bacterial cellulose solutions with or without active ingredients and be provided in the further embodiment of the invention, a transfer of these drugs through the skin. The fact that the water or the liquid is reversibly bound in the bacterial cellulose, the material supports in conjunction with energetic rays or sound waves preferably a temperature-driven mass transfer with a biological tissue see. This is done by an increase in the evaporation of substances, which is caused by the fact that energy is or was supplied from the outside.

Furthermore, it has been found that bacterial cellulose enables a hydrobalance, a substance transfer and a purification of the biological tissue during, but also after the treatment with energetic rays or sound waves. This can be done in such a way that substances and germs from the upper regions of an adjacent biological surface, such as the z. As a skin, reinforced immigrate into the material or in the protective layer or germs attach to the lower material surface, without damaging the skin or the biological tissue. The invention thereby supports the cellular balance in such a way that tissue regeneration is naturally promoted in conjunction with a solution exchange. This in turn has an influence on fibroblast activation as well as on other cellular processes. This is also evident in the way that the dandruff and - - A skin pigmentation, for example, after radiotherapy, is reduced by the inventive edition. The formation of a Radidermatitis is thus reduced in the area of irradiated skin areas.

Since the material is a biocompatible and preferably native wet material, the field of application is not limited to intact skin. The material may also be used in wounds or biological tissues in conjunction with additional radiation or sonication therapy. In doing so, the energetic radiation or the sound waves in the overlay or in the shell itself will also generate heat. The heat development in the overlay and over the biological tissue is used as an additional driving force for the mass transfer. This compatible effect shortens the mass transfer times and improves the acceptance in the application and economic use. A further advantage is that high-energy infrared or ionizing radiation, laser light or ultrasound waves damage the skin and the inner tissues to a lesser extent due to the high protective content of the water in the overlay. In addition, less heat in the biological tissue and temperatures above 45 ⁰ C are very largely avoided.

According to another aspect of the invention, it is provided that the bacterial cellulose hydrous tissue can be sterilized and purified in water vapor or by another method. The type of cleaning can be done by washing, but also by suitable solvents and cleaning agents. In order to clean the hydro-tissue, which always has to be wet, with an ultrasound probe or the ultrasound probe itself, a specially designed cleaning and storage device with a spray nozzle can be used. Since there are currently no suitable and specific ultrasonic probe cleaning devices, this device can also wash out the commercial gel. The bacterial cellulose used is stable against alcoholic solutions, but also against alkalis. Thus, appropriate cleaning agents can be used to ensure hygiene. Furthermore, it is conceivable that the hydro tissue is also formed or connected as a sponge, nonwoven or gel pad or partially or completely encased. Envelopes or additional coverings may be latices, silicones, polyurethanes, and other films or shells, with or without pores, that allow water molecules to pass outward to allow for a water film.

According to the invention, it is preferable to use a bacterial cellulose hydrocloth or in combination with a plastic material or a combination of these materials in the form of a gel-like film, woven or nonwoven fabric or a sponge-like structure. Here are z. As bacterial celluloses suitable that have no thin and delimited layer structure, similar to a puff pastry or as the pages in a book. A uniform and consistently high material layer with thicknesses between 0.2 - 20 mm transmits the sound better than a non-uniform structure. It is not important how the bacterial cellulose is made, but only important that this cellulose produces its own liquid or water film. Here it was found that a uniformly structured and synthetically produced bacterial cellulose having a surface roughness between 10 - 500 nm and a more than 60% by weight of herauspressbarem water or a liquid is preferred to z. B. to allow a 1 - 200 microns thick water layer or a water film. By pressing out or slight mechanical pressure from above, more water can get onto the surface and thus increase the film thickness. Thicker film thicknesses arise only where z. B. from above a pressure is generated. The bacterial cellulose has an average degree of polymerization with a DPw value between 4000-9000. This bacterial cellulose may contain other components or fillers which are firmly crosslinked with the cellulose and / or only stored. This is necessary if the material is to be freeze-dried or if the hydro fabric must meet certain mechanical requirements. The freeze-dried bacterial cellulose must be soaked with a solution adapted to the application before use.

In the present invention, the contained water or liquid is physically mobile and may, for example, evaporate. Due to the evaporation effect and the low surface roughness in the nm range a direct contact with the adjacent surface is created. Flat contact improves and increases the exchange of matter with a biological surface. It has also been found that the preferred bacterially synthesized cellulose can also contain small quantities of plastic fibers with thicknesses in the μm range in small quantities. A mixed tissue of foreign fibers and biological fibers is created by the biological activity of Acetobacter Xylinum bacteria, which weave the foreign fibers with bacterial cellulose. In the interstices of the network, water and solution molecules are preferably connected by hydrogen bonding and OH groups on the cellulose threads. In a simple embodiment, a pure and native bacterial cellulose or a mixed material with other hydrogels, such as Kollidon or other substances, such as. As hyaluronic acid, can be used. The known manufacturing process ensures that the bacterial cellulose has a mean degree of polymerisation (DPw value) of at least 4000. According to the desired properties, 0.1-10% of PVA, CMC or MC or other additives in the form of hydrogels may be added to the nutrient medium. - -

Bacterial cellulose in the form of pads or shells are inoculated by known manufacturing processes with cellulose-forming bacteria, for example with a dimensionally stable cellulosic layer producing strain of the microorganism Acetobacter Xylinum and cultured at a temperature of about 28 ⁰ C (see preparation WO01061026, DE 100 2275C2). The nutrient solution contains in a known manner D-glucose, disodium hydrogen phosphate, citric acid and standard extracts. The stability and internal structure of the bacterial cellulose can be improved in the production by additional additions of water-soluble polymers or tissue fibers or nets. These additives can z. As polyvinyl alcohol (PVA), carboxymethyl cellulose (CMC) or methyl cellulose (MC) or similar additives. These additives are added in concentration between 0.1-10% to the culture medium. The total water content of a suitable hydro tissue is between 80-99% by weight and may, however, be 70% by weight with additives or by removal of water, the extrudable fraction being at least 60%. Due to the fabric-like structure, the bacterial cellulose, especially at thicknesses below 5 mm, has good semitransparent properties. At thicknesses above 10 mm, the hydro tissue is no longer transparent. In a further development of a known production method, for the first time a matrix, impression or a shaped substrate or base was introduced into the production container, it was observed that the bacteria reproduce this shaped substrate. This results in an edition but also shell with different thicknesses or with a suitable impression for resting on the eyes, noses, extremities, breast and Pobereich or other shaped areas of the human body.

The construction of the pads, sheaths and / or sheath may be designed such that a perforated foil or a film with visible pores for the expansion of the usability of the material is introduced during the manufacturing process. The connection is not made by sewing, but by depositing the film on an existing cellulose layer. Subsequently, the structure is wetted with inoculated nutrient solution and the process of wetting repeated. Alternatively, the bacterial cellulose may have holes to connect to an ultrasound probe or in conjunction with a holder therewith. Also conceivable is a device in the form that a Velcro strip is sewn with a bacterial cellulose. With this device, the material can completely or partially envelop a probe tip.

The appropriate hydro-tissue pad has high ductility and flexibility and can be used on uneven areas of the skin such as the knee, face or shoulder. -LO area, rest. Thus, the pads offer good overall properties for the application z. B. in the form of a plaster, as a wound dressing, as an envelope or as Päd.

The strength and structure of the hydro tissue has the advantage that the pads or sheaths from the hydro tissue can be treated by simple cleaning and / or sterilization. A simple cleaning is done in the form that the used material is cleaned in boiling water. The procedure is as follows: used Hydroauflagen be introduced into a vessel with a lid and doused with sufficient boiling water. Subsequently, salt or a salt mixture is added to a physiological saline solution, eg. B. Ringer or saline solution to produce. As an alternative to boiling water, the hydro tissue is placed in a physiological solution and the solution is boiled by a microwave oven. After cooling, the hydro tissue is as good as sterile and can be used. Advantageous are cleaning process in which z. For example, a spray jet is also used for cleaning in order to remove particle deposits on the material.

The cleaning can also be done automatically with a cleaning device having a spray nozzle in the bottom. This may be useful if the material is used in conjunction with an ultrasound probe or ultrasound probe and should not be removed from this probe in every application. At the same time, the device serves as a storage device in order to keep the bacterial cellulose moist. Alternatively, it can be further provided that the cleaning or storage solution contained here is boiled in the device by means of heating rods in order to achieve a sterilization. A device for cleaning ultrasound probes improves the hygiene in the field of UI rapid diagnosis altogether even without the connection with hydromaterials. In this case, the device can be used alone, but also in conjunction with an ultrasound device application.

Fields of application and embodiments

According to the invention, the overlay or wrapper may be used as follows: a) The overlay is placed or preceded in the first step as a protective, barrier or transfer layer on a biological tissue surface. In this case, z. As infrared rays or ultrasonic waves on this layer of material and are transmitted to the biological tissue surface. The radiation is filtered by the water content and substance content and sound waves forwarded. She was- Ineentwicklung or the sound entry is thus not directly on the tissue surface. Tissue damage is avoided. After treatment, the material remains on the fabric for a certain time and continues to exchange fabrics with the adjacent surface. b) A bacterial cellulose pad or bacterial cellulose pad or sheath is mechanically releasably bonded directly to the probe head via, for example, a fixation device. The probe thus prepared is placed on the skin of a patient or passed over the skin and thus carried out an ultrasound diagnosis or treatment.

Embodiments of the dressings, sheaths, wraps and / or caps made of bacterial cellulose result from the applications. These may include the following embodiments:

1. Small pads in round or oval shape for eye applications. 2. Larger pads in round or rectangular shape to cover irradiation fields.

3. Small pads with thicknesses up to 1 -2 cm for therapeutic ultrasound treatments.

4. Elongated sleeves or caps or moldings with an opening for ultrasonic probes for insertion into body orifices. 5. Cover as sheaths for other ultrasound probes.

6. Strip-shaped pads for the neck area or for extremities.

7. Covers with apertures to cover surgical areas for microsurgical procedures.

8. Covers with suitable recesses or formations to fit the breast, buttocks, mouth, nose, eyes or face.

9. Devices in which the bacterial cellulose is connected to a holder, staple, Fixiermanschette or with other foreign materials to allow the sheet or shaped bacterial cellulose with z. B. a probe to connect.

In the field of ultrasound diagnosis and treatment, bacterial cellulose or the inventive hydro tissue is suitable for the following fields of application:

• Ultrasonic diagnosis of the thyroid gland

• Pediatric ultrasound diagnosis

• Ultrasound diagnosis in gastroenterology • Cardioechography

• Ultrasound diagnosis in dermatology

• Ultrasound diagnosis in traumatology (eg depth of necrosis) _

• Ultrasound therapy in sports physiotherapy

• Ultrasound therapy for poorly healing wounds and fractures

• Focused ultrasound therapy

• Ultrasonophoresis

In a preferred embodiment in the form of a flat support, the hydro tissue contains an alcoholic or antibacterial solution and is applied as a contact surface on the skin in order to enable image diagnostics. In the field of another ultrasound diagnosis, a rod-shaped ultrasound probe is covered with a cap made of hydro tissue. In the reusable form, this cap is additionally slipped over with a latex tube and introduced, for example, in the vaginal opening. The advantage is that no contamination or contamination on the ultrasound probe occurs and the cleaning of the probe from the gel is unnecessary. Alternatively, the latex tube is omitted if the product is to be used as a disposable product and / or sterile.

An embodiment in which the bacterial cellulose or the hydro tissue surrounds or envelopes an ultrasound probe in the front area is also preferred. For example, to use a flat strip, which is also available as a support for a wrapper, this z. B. sewn with a Velcro or otherwise connected. Since the material is sewable, z. B. the material and the Velcro strip with a sewing thread or alternatively a clip connected. This device allows the flexible fixation of the material with an ultrasound probe. Alternatively, a molded Kunststoffhalte- tion or a molded part with a clamping zone connect the material mechanically releasable. Most simply, this task can also take over a ring, a clamping spring or fixing collar.

A practical application of the invention is the treatment of body regions with infrared light. Here are flat pads with a thickness between z. B. 1 - 6 mm placed on the skin and irradiated at a defined distance with a conventional infrared source. For smaller surfaces and a higher radiation dose, larger thicknesses are used. The high-energy infrared light impinges on the Hydrogewebeauflage and generates an elevated temperature here. The safe part of light is filtered out by the containing water. Despite the elevated temperature, the skin does not suffer from skin damage due to the cooling effect of the overlay. The increase in temperature in the irradiated area allows a faster absorption of substances from the upper layers of the skin and thus leads to purification. In cosmetic and / or hygienic embodiments, the hydro tissue may contain substances such as hyaluronic acid, soluble collagen, pharmaceutical or cosmetic active ingredients, tannin, vitamins, vegetable extracts, oils etc. or other cosmetically relevant active ingredients with or without disinfectants and / or cleaning solutions or by Inkuba - tion with a solution containing these substances are introduced. Bacterial cellulose dressings are used here for the treatment of scar tissue or after peeling of the skin in combination with laser or ultrasound probes. The aim is to introduce cosmetic substances, water and / or physiological solutions into the upper layers of the skin. This may be useful if an injection with hyaluronic acid has previously taken place.

The invention can be applied to all fields of life as well as to commercial or industrial applications where a protective, cooling and transfer pad or sheath with an exchange of substances, liquids, media or particles is desired. In particular, wherever it is necessary to ensure an economical cosmetic and medical treatment.

Further advantages of the invention will become apparent from the choice of the field of application, the forms of treatment and applications as well as by an economical use of the materials used and from the description and the attached drawing.

It is understood that the features mentioned above and those yet to be explained can be used not only in the particular combination indicated, but also in other combinations or alone, without departing from the scope of the present invention.

EXEMPLARY EMBODIMENTS

Embodiments of the invention are illustrated in the drawing and are explained in more detail in the following description. Show it:

Fig. 1 Use and function of the invention in the ultrasonic diagnosis or treatment as a support or shell in contact with a surface.

Fig. 2a formation of a water film in conjunction with an ultrasonic head. Fig. 2b. Support for producing a flat surface on an uneven surface.

Fig. 3. Use and function of the invention in the infrared treatment of tissue.

Fig. 4. Use and function of the invention in radiation treatment with ionizing

Rays.

Fig. 5. Use and function of the invention in examination in body cavities.

Fig. 6. Detailed view of a jacketed bag with a media supply.

Fig. 7. Device with a Velcro in conjunction with an ultrasound probe

FIG. 1 shows the use and function of the invention in ultrasound diagnosis or treatment as a support or sleeve in contact with a surface. Figure A shows a hydro-tissue 1 or a hydro-layer, which rests on a surface 12 of a skin or a material 5. As a result of the pressure (arrow e.) Of the probe 4 from above, further water is forced out, at least on the surface 3, and a thin film of water (not shown) is formed. This film may also form between the surface 12 and the outer surface of the bacterial cellulose. The outer surface 3 also allows evaporation of the water. In the case of a skin layer, the hydro-tissue 1 can absorb substances (arrow d.) From the skin or optionally also offer substances for replacement. To determine an ultrasound image, the ultrasound probe 4 rests directly on the surface 3 of the support 1. The ultrasound 9 is on the support 1, z. On the surface 3, into the material 5 (eg skin). At 10, the echo is shown, which takes its way back to the probe. In Figure B is an ultrasound probe 4, at least in the front part of a hydro-tissue sleeve 2 sheathed and z. B. fixed with a silicone ring 6 at this. The pressure from above (arrow e) also produces a film of water between the surface 3 and the outer surface of the probe. The depressed water content, however, can not drain. In Figure C, a sleeve 2 is also shown in section, which covers an ultrasonic head 4. Here, however, the ultrasound head is not directly on the hydro tissue, but inside the sleeve 2 is a space 8, in which a solution or a gel can be introduced. This solution is used for sound transmission and the water film between the bacterial cellulose and the skin or material improves the sound transmission. Through the use of bacterial cellulose, the sound signal is optimally forwarded. The sleeve 2 is fixed with a sleeve 7 so that the inner solution or the material can not escape. The latter embodiment can preferably be used in material testing, but also for the introduction of active ingredients into the skin.

FIG. 2a. shows the formation of a water film in conjunction with an ultrasound head. It is shown how by pressing from above (arrow e) additional water or aqueous medium (arrow g.) Is pushed out of a hydro tissue 1 or a hydro layer and accumulates between ultrasound head 4 and the surface 3 to a visible aqueous film 33. The film 33 is only a few microns thick and the aqueous medium is forced by the pressure from top to outside 34. Although the thickness of the film is reduced, the contact with the inner movable liquid layer remains. This layer 33 in the form of a glossy skin already forms by the weight of the material. In this layer thickness it is hardly visible on the surface of the material. A water film also forms between a biological tissue and the overlay, but this film is affected by the evaporation through the hydrocloth. Furthermore, this creates a direct contact and exchange with the mobile medium in the support (arrow g.). Depending on the pressure, density and structure of the hydro-textile 1, a permanent aqueous film can form between the lower side of the hydroentangle 1 and the surface 12. By evaporation (arrow f) liquid is discharged to the outside and this in turn sucks liquid (arrow d) z. B. from the skin 5 on. Due to the soft and deformable surface 3 of the hydro-tissue 1, the film continues to move with the movement of the ultrasound head, thus enabling optimum coupling for the ultrasound signal.

Fig. 2b. shows a support for producing a flat surface on an uneven surface. Shown is a support 1, which has a Ab- or molding 35. By this formation 35, the support optimally covers an uneven surface 12, z. B. from an uneven body region 5 in order to carry out a treatment here. A tarp or planar outer surface 3 is made into an uneven surface. Also shown is an ultrathin liquid layer 33, which is particularly typical of thicker bacterial cellulose pads. Due to the flat surface with a soft deformable surface 3, the ultrasonic probe can lie smoothly without an air layer and the sound can be coupled in here. The transmission 9 and reception signal 10 is optimally introduced. Thus, the edition improves the use of the echo-pulse method. Alternatively, a sheath may have ab- or formations.

Figure 3 shows the use and function of the invention in the infrared treatment of tissue. On the skin 5 of a patient is a two-dimensional hydro-tissue support 1. About a spaced light source 14 ultra-bright light 11 of different intensity is emitted. The emitted light 11 is filtered by the support, which is in direct contact with the skin surface 12, and only the longer rippled light is transmitted. In the skin 5, the penetrated red light component generates a heating. This in turn drives the evaporation over the surface 3 (see arrow a.) and allows cooling, despite the energy supply to the skin. A water film 33 can likewise form at the boundary layer 12, since the entry of the tissue water into the overlay 1 is also controlled by the evaporation and more liquid can be offered via the skin than is evaporated.

FIG. 4 shows the use and function of the invention in radiation treatment with ionizing radiation. Corresponding to FIG. 3, ionizing or electromagnetic radiation is emitted via an X-ray or other radiation source 15. Spaced apart here is a support 1 on a skin surface 12. The radiation 13 penetrates via the surface 3 first in the hydro tissue 1 and generates a scattered radiation 16, which penetrates in a typical manner (arrows a) in the skin or in an adjacent tissue 5. Due to the thickness of the flow path of the support 1, a suitable dose of action is introduced into the upper tissue region. As the material cools continuously and material exchange takes place, combined treatments can be made possible. The development of heat as a secondary effect or with a time delay and concomitant increased perspiration of the skin may occur. In this case, an aqueous film 33 can likewise form in the contact area skin / support.

FIG. 5 shows the use and function of the invention during examination in body cavities. A rod-shaped ultrasound probe 4 is surrounded in the front region with a hydro tissue 2. Alternatively, the material can completely envelop the insertable probe region 4. With a silicone ring 6 or a sleeve 7, the shell is connected to the head part. The Hydrogewebehülle 2 is used for ultrasonic transmission into a body cavity 17. At the interface between body tissue and bacterial cellulose 12, a water film 33 is formed by mechanical pressure of the ultrasound probe. This is also possible because the tissue itself can give off fluid. If no additional casing for protection and only one sterile casing 2 made of bacterial cellulose is used, a mass transfer can also take place here. Alternatively, the device may additionally be surrounded by a thin latex sheath which serves as protection against infections. This additional plastic sleeve can be discarded. Shown is the application of an echo-pulse method. Alternatively, a therapeutic ultrasound for the treatment of the tissue can also be used here. Also conceivable would be the destruction of kidney stones. Here, the bacterial cellulose would serve as a transmission medium for shockwaves.

FIG. 6 shows a detailed representation of a jacketed bag with a media feed. The sectional view shows a bag 18, which is covered by a hydro fabric 2. The bag 18 is supplied via a hose 19 with solution. At 20 it is shown that via channels in the bag 18 substances can penetrate the wall of the shell 2. Alternatively, the interior 8 of the bag 18 may also be impermeable to solutions. In this case, radioactive rays 13, z. As technetium introduced. Due to the high aqueous content of the bacterial cellulose casing 2, a suitable scattered radiation 16 is made possible. The latter in turn can destroy cancer cells inside a body. Instead of a bag, a catheter may be embedded or sheathed with the hydro tissue here. This device has the advantage that the inner patient tissue can be specifically irradiated.

FIG. 7 shows a device with a Velcro strip in conjunction with an ultrasound probe. Figure A shows a device in which a hydro tissue 1 from a bacterial cellulose strip is sewn terminally with a hook and loop tape 37 via sewing threads 38. Alternatively, a molded part can also clamp the hydro tissue at the terminal end. This molded part, in turn, is part of a holding or fixing device and can be connected to a suitable holding trough or holding counterpart on the ultrasonic head so as to fix the hydro-tissue to the ultrasonic head. The Velcro 37 should allow the changeable fixation. In this case, the hydro-fabric 1 may also have lateral elevations or an edge or have a shoe-like shape. With this device, a dargesteller in Figure B ultrasound head 4, wrapped or wrapped in the front. This connection is shown in Figure C. The Velcro strip 37 has created a detachable connection. Figure D shows a detail in a side view. In side view, the flanks 41 of the front ultrasound head region 4 are enveloped by the bacterial cellulose 1. By means of the Velcro strip 37, the bacterial cellulose strip is changeably connected to the transducer 4. By virtue of the fact that the coated transducer 4 can be stored in a liquid-filled storage container or holder, liquid 39/8 will accumulate if the material 1 does not fit snugly against the lower region of the probe 4. If the probe is used (Figure E), liquid 8/39 is displaced and liquid from the bacterial cellulose 1 is also distributed to the skin 12 by pressure from above. A thin liquid film 33 forms, which ensures that the probe 4 slides over the skin surface 12 and the ultrasonic signal is coupled in. The fact that the material 1 contains a lot of liquid, it is ensured that enough liquid is supplied. Part of the liquid can also be deposited laterally. Alternatively, if a suitable shell, cap or a suitable shaped body is used, an optimal form fit with the ultrasound probe would be given. In addition, an additional fluid reservoir could be located here to provide fluid to the front transducer area.

Claims

claims

1st edition, sheath and wrapping in the field of medical, pharmaceutical, cosmetic and technical applications, characterized in that they consist of a hydro tissue (1, 2) of bacterial cellulose fibers or of a fiber composite material and with a water or aqueous solution fraction from the hydro tissue (1, 2) at least one own aqueous film (33) or a thin aqueous layer is formed on or between material surfaces (3, 12) for coupling sound waves and in connection with the remaining solution proportion in the hydro tissue (1, 2) provides a transmission medium for sound waves (9, 10) or decelerates, scatters or filters out radiation (11, 13).

Second edition, casing and sheath according to claim 1, characterized in that the hydro fabric (1, 2) is used as a flow path for sound waves and / or filter section for io- nisierenden beams, laser and infrared light and the aqueous film

(33) by a movable and herauspressbaren solution portion in the hydro fabric (1, 2) builds up by itself and / or by pressure from above.

3. edition, casing and sheath according to claim 1, characterized in that the hydro fabric (1, 2) is deformable and consists only of a Fasemart or contains additional foreign fibers or networks and / or gel body or hydrogels and thereby an aqueous contact and sliding layer provides for an ultrasound probe and supplies this layer with liquid via a containing mechanically mobile and releasable aqueous solution fraction.

4. Edition, casing and sheath according to claim 1 to 3, characterized in that it sucks on biological or technical surfaces or here fits tightly and / or slides over these surfaces.

5. casing and sheath according to one of claims 1 to 4, characterized in that between the ultrasonic probe (4) and a surface (3), a space (8) is formed, in which solution, gel or water is.

6. casing and sheath according to one of claims 1 to 5, characterized in that it encloses an ultrasound probe (4), a bag (18), a catheter, a limb completely, partially or only in the front region.

7. envelope and sheath according to claim 6, characterized in that this encloses a bag (18) or catheter and the bag or catheter through a hose (19) is supplied with solution.

8th edition, casing and sheath according to claim 1 to 7, characterized in that the hydro fabric (1, 2) by externally supplied sound waves, shock waves or radiation energy has an increased mass transfer.

9. Edition according to one of claims 1 to 8, characterized in that it is used as a protective or transfer pad during and after a treatment.

10. Circulation according to claim 9, characterized in that it covers a wound or an OP-FeId or a skin surface to be irradiated or comes into contact with a wound or biological tissue and / or organs.

11th edition, casing and sheath according to one of claims 1 to 10, characterized in that the hydro tissue (1, 2) generates a scattered radiation (16) or filters out short-wave light.

12th edition, casing and sheath according to one of claims 1 to 11, characterized in that it consists of bacterial cellulose and has a surface roughness of 10 - 500 nm and a DPw value of 4000 - 9000 has.

13th edition, casing and sheath according to one of claims 1 to 12, characterized in that it has at least on one side formations, impressions or mold structures (35).

14th edition, casing and wrapping according to one of claims 1 to 13, characterized in that the hydro fabric (1, 2) in the interior with a film or with others

Material structures in different shapes and thicknesses combined or directly linked together. - -

15. The overlay, casing and wrapping according to one of claims 1 to 14, characterized in that they can be treated by cleaning and / or cooking or sterilizing or a disinfecting, sterilizing or cleaning solutions and / or substances such as hyaluronic acid, soluble collagen, tannin, Vitamins, herbal extracts, oils or pharmaceutical and kosmetrische agents contains.

16. A device for ultrasound probes, characterized in that a hydro tissue (1, 2) is releasably connected via a mounting or a fixing device with an ultrasonic probe (4).

17. The device according to claim 16, characterized in that the device supports the sliding of the probe by liquid secretion (8, 39) and by forming a liquid film (33) on the skin or a tissue.

18. The apparatus of claim 16 and 17, characterized in that the hydro fabric (1, 2) with a hook and loop fastener (37) or with a ring (6), sleeve (7), molded part or with a holder sewn or mechanically connected.

19. Device according to one of claims 16 to 18, characterized in that the envelope of an ultrasonic probe is a strip of material, a sheath, a cap or a shaped body.

20. Device according to one of claims 16 to 19, characterized in that the hydro tissue (1, 2) encases or envelops the lateral flanks (41) of an ultrasound probe.