EP2934409A1 - Corps d'aspiration pour le traitement thérapeutique d'une plaie par dépression - Google Patents

Corps d'aspiration pour le traitement thérapeutique d'une plaie par dépression

Info

Publication number
EP2934409A1
EP2934409A1 EP13811940.9A EP13811940A EP2934409A1 EP 2934409 A1 EP2934409 A1 EP 2934409A1 EP 13811940 A EP13811940 A EP 13811940A EP 2934409 A1 EP2934409 A1 EP 2934409A1
Authority
EP
European Patent Office
Prior art keywords
wound
absorbent body
negative pressure
superabsorbent polymer
deep
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP13811940.9A
Other languages
German (de)
English (en)
Inventor
Pierre Croizat
Axel Eckstein
Cornelia Wolf
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Paul Hartmann AG
Original Assignee
Paul Hartmann AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Paul Hartmann AG filed Critical Paul Hartmann AG
Publication of EP2934409A1 publication Critical patent/EP2934409A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/53—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the absorbing medium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91—Suction aspects of the dressing
    • A61M1/915—Constructional details of the pressure distribution manifold
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91—Suction aspects of the dressing
    • A61M1/916—Suction aspects of the dressing specially adapted for deep wounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00536—Plasters use for draining or irrigating wounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F2013/00361—Plasters
    • A61F2013/00727—Plasters means for wound humidity control
    • A61F2013/00748—Plasters means for wound humidity control with hydrocolloids or superabsorbers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/53—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the absorbing medium
    • A61F2013/530481—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the absorbing medium having superabsorbent materials, i.e. highly absorbent polymer gel materials
    • A61F2013/53051—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the absorbing medium having superabsorbent materials, i.e. highly absorbent polymer gel materials being only in particular parts or specially arranged
    • A61F2013/530547—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the absorbing medium having superabsorbent materials, i.e. highly absorbent polymer gel materials being only in particular parts or specially arranged positioned in a separate layer or layers
    • A61F2013/530554—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators characterised by the absorbing medium having superabsorbent materials, i.e. highly absorbent polymer gel materials being only in particular parts or specially arranged positioned in a separate layer or layers and being fixed to a web

Definitions

  • the invention generally relates to an absorbent body for the therapeutic treatment of a wound on the human or animal body by means of negative pressure.
  • the invention relates to an absorbent body for the therapeutic treatment of a wound, which comprises on its surface a sensitive and intact body deep-lying tissue structure such as a tendon or bone, by means of negative pressure.
  • a wound is understood to mean the separation of the connection between tissues of the body shell in humans or animals. It can be associated with a loss of substance.
  • W01993 / 009727 describes a device for promoting wound healing by the application of negative pressure on the skin area having the wound and surrounding the wound.
  • the device according to W01993 / 009727 comprises a vacuum device for generating the negative pressure, an airtight cover of the wound designated as a sealing device, which is in a functional connection with the vacuum device, and a wound dressing designated as a protective device for positioning on the wound within the sealing device.
  • Protective device is an open-cell polymer foam
  • polyester foam for example, polyester foam.
  • the use of negative pressure therapy can accelerate wound healing of different types of wounds such as burns, pressure sores or lacerations.
  • Devices for negative pressure therapy are commercially available, for example, the therapy system Vivano ® the applicant Paul Hartmann AG (Germany). Both commercially available devices for negative pressure therapy of wounds is often a wound dressing of an open-cell polymer foam used. In practice, it has been shown that wounds which include sensitive and intact body deep-lying tissue structures such as tendons or bone on their surface, can only be treated unsatisfactory with such devices, since there is a risk of dehydration of the bone and tendon tissue.
  • WO2010 / 075313 is directed to a negative pressure therapy system comprising a membrane which is brought into contact with the tissue to be treated with negative pressure.
  • the side of the membrane resting on the tissue to be treated has a multiplicity of protuberances which form at least one channel which forwards the negative pressure to the tissue.
  • the system is preferably used for the treatment of bone tissue, wherein the preferably flexible, biodegradable membrane to which the suction tube is connected at least partially covers the bone.
  • an absorbent body which comprises a superabsorbent polymer is suitable as a wound dressing for the negative pressure therapy of a wound which comprises sensitive tissue structures lying deep in the intact body, such as, for example, tendons or bones, on its surface.
  • the absorbent body is in this case brought into contact with the sensitive tissue structure during the negative pressure therapy, so that the structure is protected by the absorbent body until it is covered by newly formed granulation tissue.
  • the protective effect and the therapeutic success is particularly pronounced when the absorbent body is subjected to a solution.
  • the absorption of the absorbent body always takes place before the wound therapy, for example by the manufacturer or immediately before the therapy by the user.
  • the delicate and intact body deep tissue structure is kept in a moist environment and does not dry out, so that the tissue structure does not die during the negative pressure therapy and rapid and successful wound healing is promoted.
  • Further advantageous properties of the absorbent body acted upon by a solution are its soft structure and its low tendency to stick to the wound surface and / or to grow together.
  • the invention relates to an absorbent body comprising a superabsorbent polymer for the therapeutic treatment of a wound comprising on its surface a sensitive tissue structure lying deep in the intact body by means of negative pressure, the absorbent body preferably applying a solution, in particular Ringer's solution is.
  • the invention according to this first aspect comprises a product for the therapeutic treatment of a wound, wherein the product is an absorbent comprising a superabsorbent polymer and wherein the product is for use in the negative pressure therapy of a wound having on its surface a sensitive and in the intact body comprises low-lying fabric structure is used.
  • the product is preferably applied with a solution, in particular with Ringer's solution.
  • the invention also relates to the use of an absorbent body comprising a superabsorbent polymer, for the therapeutic treatment of a wound, which comprises on its surface a sensitive and deep-seated intact body tissue structure, by means of negative pressure, wherein the absorbent body
  • the invention according to the first aspect therefore provides:
  • a superabsorbent polymer for the therapeutic treatment of a wound, which comprises on its surface a sensitive tissue structure deep in the intact body, by means of negative pressure, wherein the superabsorbent polymer is contained in an absorbent body and wherein the absorbent body is preferably applied with a solution, in particular with Ringer's solution is.
  • a superabsorbent polymer for the production of an absorbent body for use in the therapeutic treatment of a wound, which comprises on its surface a sensitive tissue structure deep in the intact body, by means of negative pressure, wherein the absorbent body is preferably applied with a solution, in particular with Ringer's solution.
  • the invention according to a second aspect comprises an absorbent body comprising a superabsorbent polymer for the therapeutic treatment of a wound by means of negative pressure, wherein the absorbent body is brought into contact with the tissue structure during treatment with a sensitive tissue structure deep in the intact body at the surface of the wound to protect against dehydration, and where the
  • the invention preferably with a solution, in particular with Ringer's solution, is acted upon.
  • the invention according to this second aspect comprises a product for the therapeutic treatment of a wound, wherein the product is an absorbent comprising a superabsorbent polymer, and wherein the product is at the surface during a negative pressure therapy with a delicate tissue structure deep in the intact body the wound is brought into contact to protect the tissue structure from dehydration.
  • the product is preferably applied with a solution, in particular with Ringer's solution.
  • the invention also relates to the use of an absorbent body comprising a superabsorbent polymer, for the therapeutic treatment of a wound by means of negative pressure, wherein the absorbent body is brought into contact with the surface of the wound during treatment with a sensitive tissue structure which is deeply embedded in the intact body, in order to protect the fabric structure from drying out, and wherein the absorbent body is preferably subjected to a solution, in particular Ringer's solution.
  • a solution in particular Ringer's solution.
  • the invention according to the second aspect thus provides:
  • a superabsorbent polymer for the therapeutic treatment of a wound by means of negative pressure wherein the superabsorbent polymer is contained in an absorbent body and wherein the absorbent body is brought into contact with the tissue structure during treatment with a sensitive and intact body deep tissue structure at the surface of the wound to protect against dehydration, and wherein the absorbent body preferably with a solution, in particular with Ringer's solution, is applied.
  • the product is preferably applied with a solution, in particular with Ringer's solution.
  • the second aspect of the invention thus also relates to the use of an absorbent body comprising a superabsorbent polymer for the therapeutic treatment of a wound by means of negative pressure, wherein the absorbent body during the treatment for contacting with a sensitive tissue structure deep in the intact body provided on the surface of the wound is to protect the fabric structure from dehydration, and wherein the absorbent body is preferably applied to a solution, in particular Ringer's solution.
  • the invention thus provides, based on the substances used in the therapeutic treatment of wounds, the invention thus provides, based on the aforementioned second aspect:
  • a superabsorbent polymer for the therapeutic treatment of a wound by means of negative pressure wherein the superabsorbent polymer is contained in an absorbent body and wherein the absorbent body is provided at the surface of the wound during the treatment for contacting a sensitive and intact body tissue structure to protect the fabric structure from drying out, and wherein the absorbent body is preferably subjected to a solution, in particular Ringer's solution.
  • a superabsorbent polymer for the manufacture of an absorbent body for use in the therapeutic treatment of a wound by means of negative pressure, wherein the absorbent body is provided at the surface of the wound during treatment for contacting a delicate and intact body tissue structure to the tissue structure to protect against dehydration, and wherein the absorbent body preferably with a solution, in particular with Ringer's solution, is applied.
  • the invention comprises an absorbent body comprising a superabsorbent polymer for the therapeutic treatment of a wound by means of negative pressure, wherein the absorbent body is used during the treatment to moisturize a sensitive tissue structure deep in the intact body on the surface of the wound in order to project the tissue structure Desiccation to protect, and wherein the absorbent body preferably with a solution, in particular with Ringer's solution, is applied.
  • the invention according to this third aspect comprises a product for the therapeutic treatment of a wound, wherein the
  • the invention also relates to the use of an absorbent body comprising a superabsorbent polymer for the therapeutic treatment of a wound by means of negative pressure, wherein the absorbent body is used during the treatment to moisturize a sensitive tissue structure deep in the intact body at the surface of the wound to protect the fabric structure from drying out, and wherein the absorbent body is preferably subjected to a solution, in particular Ringer's solution.
  • the invention according to the third aspect thus provides:
  • a superabsorbent polymer for the therapeutic treatment of a wound by means of negative pressure wherein the superabsorbent polymer is contained in an absorbent body and wherein the absorbent during the treatment for moisturizing a sensitive and In the intact body deep-lying tissue structure is used on the surface of the wound to protect the tissue structure from drying out, and wherein the absorbent body preferably with a solution, in particular with Ringer's solution, is applied.
  • the absorbent body and the superabsorbent polymer contained therein are claimed in connection with the specific application in a method of therapeutic treatment (specific medical indications).
  • a specific application in a method of therapeutic treatment specifically medical indications.
  • Treatment in the context of the present invention is the treatment of a wound by means of negative pressure, wherein the wound on its surface comprises a sensitive tissue structure deep in the intact body according to the definitions made in the present document.
  • the effect of the absorbent body and the superabsorbent polymer contained therein is to be seen in particular to keep the fabric structure moist during the treatment and thus to protect against dehydration, for which the absorbent body with the therein contained
  • the superabsorbent polymer is preferably brought into contact with the fabric structure and is preferably applied to a solution.
  • Another specific application in a method of therapeutic treatment (specific medical indication) in the context of the present invention is the protection of a sensitive and intact body deep tissue structure according to the definitions given herein on the surface of a wound which is treated with negative pressure, before dehydration, for which the absorbent body with the superabsorbent polymer contained therein is preferably brought into contact with the fabric structure and is preferably applied with a solution.
  • the invention includes a device for negative pressure therapy of wounds.
  • the device comprises an air-impermeable cover material with which the wound is sealed airtight.
  • the device further comprises a means for functional connection of the wound space with a vacuum source located outside the cover material.
  • a vacuum source located outside the cover material.
  • the device comprises at least one absorbent body or at least one product or superabsorbent polymer according to one of the aforementioned aspects of the invention, which can be introduced into the space between the surface of the wound and the covering material or
  • Vacuum source located outside the cover material, so that a negative pressure in the wound space can be produced and liquids are sucked from the wound space, wherein the absorbent body preferably with a solution, in particular with Ringer solution, is applied and preferably with the sensitive and intact body deep-lying tissue structure on the surface the wound is brought into contact.
  • the method for use in the negative pressure therapy of wounds comprises a further step in which a pressure distribution layer is introduced into the wound.
  • the method comprises the following steps: a) introducing a absorbent body comprising a superabsorbent polymer into a wound, which has on its surface a delicate tissue structure which is located deep in the intact body,
  • a pressure distribution layer preferably a pressure distribution layer comprising a foam, particularly preferably a pressure distribution layer comprising an open-cell polyurethane foam, into the wound, c) sealing the wound by means of an air-impermeable covering material, so that a wound space is formed between the surface of the wound and the covering material, which comprises the absorbent body and the pressure distribution layer,
  • Vacuum source located outside the cover material, so that a negative pressure in the wound space can be produced and liquids are sucked from the wound space, wherein the absorbent body preferably with a solution, in particular with Ringer solution, is applied and preferably with the sensitive and intact body deep-lying tissue structure on the surface the wound is brought into contact, and wherein the pressure distribution layer is preferably arranged between the absorbent body and the cover material.
  • a further method for use in the negative-pressure therapy of wounds can be followed by the methods mentioned, which comprises the following steps: a) introducing a wound dressing, preferably a wound dressing comprising a wound dressing
  • Foam particularly preferably a wound dressing comprising an open-celled polyurethane foam, into a wound,
  • the absorbent according to the invention comprises a superabsorbent polymer.
  • a superabsorbent polymer is generally understood to be a water-insoluble swellable polymer which can take many times its own weight of liquid, such as water, saline solutions or body fluids. The fluid intake leads to the formation of a hydrogel. The clean water capacity is typically higher than the saline liquid capacity.
  • the term superabsorbent polymer is understood in particular to mean a polymer which according to the standard test method WSP 240.2 (05) has a free swell capacity of at least 10 g / g, preferably at least 20 g / g.
  • the test method WSP 240.2 (05) for determining the w value is described in "Standard Test Methods for the Nonwovens and Related Industries", 2008 edition
  • WSP 240.2 (05) according to EDANA is a standard test method for
  • the wounds contemplated by the present invention are wounds on the human or animal body which comprise one or more delicate tissue structures deep within the intact body.
  • Sensitive in the context of the present invention means that the tissue structure during the negative pressure therapy is exposed to a particularly high risk of dehydration, as a result of which the tissue structure may die off. This is the case in particular if the tissue structure has only few or no blood vessels and thus the mass transfer of the tissue structure or the mass transfer of parts of the tissue structure is essentially based on diffusion processes.
  • wounds with sensitive tissue structures deep in the intact body can be damaged by a mechanical trauma
  • the absorbent body according to the invention is intended to protect the sensitive and deep tissue structures in the intact body during the negative pressure therapy from dehydration by keeping them moist or equivalent holds it in a moist environment.
  • the absorbent body according to the invention is particularly suitable for keeping the sensitive and intact body deep tissue structures moisturized when it has been subjected to a solution.
  • the absorbent body according to the invention is preferably used with the sensitive and im
  • Wound contact layer can be ensured that the absorbent body according to the invention can keep the sensitive and intact body deep-lying tissue structure in a moist environment. Furthermore, it is advantageous if the tissue structure to be protected from dehydration is completely covered by the absorbent body. Depending on the size of the tissue structure to be treated in relation to the size of the absorbent body, one absorbent body may be sufficient for this purpose or several absorbent bodies must be used.
  • Criteria are, for example, the amount of exudate exuded by the wound and the proportion or size of the exposed tissue structure.
  • a risk of dehydration of the sensitive tissue structure deep in the intact body can be present in particular if the tissue structure occupies an area of at least 1 cm 2 , for example at least 2 cm 2 or at least 3 cm 2 .
  • a suitable square grid film can be applied to the wound surface. On the film, the outline of the sensitive tissue structure deep in the intact body is transferred and its area is determined by means of the dot counting method. The point counting method is described in detail in the article "What has not been documented, is not provided" (Hoppe et al, The Nurse's Sister, Volume 45, 1 1/06).
  • the absorbent body is preferably brought into contact with the fabric structure for at least 6 hours, more preferably for at least 1 day, most preferably for at least 2 days.
  • the absorbent body according to the invention is not longer than 4 days, preferably not longer than 3 days with the
  • the absorbent body can be changed and the negative pressure therapy can be continued, preferably until the tissue structure lying deep in the intact body is no longer freely present in the wound, ie it is no longer located on the surface of the wound. Until this time, a repeated replacement of the absorbent body may be required.
  • the negative pressure therapy can be carried out using other wound dressings and supplementary surgical measures, such as a split skin transplant - to be continued. It is also possible to the method proposed here for negative pressure therapy, medical standard
  • connection therapies are known to the person skilled in the art from the prior art, for example from the already mentioned WO1993 / 009727.
  • a suitable connection therapies are known to the person skilled in the art from the prior art, for example from the already mentioned WO1993 / 009727.
  • Connection therapy can also be to use a suction body as used in the present invention without the use of negative pressure as a wound dressing.
  • a connection therapy will be in the as yet unpublished European
  • the superabsorbent polymer is a superabsorbent polyacrylate.
  • the monomer content is in particular more than 70% by weight of acrylic acid and / or a salt thereof (based on the total weight of the polyacrylate).
  • polyacrylates according to the invention have a monomer content of more than 80% by weight of acrylic acid and / or a salt thereof, and more preferably more than 95% by weight of acrylic acid and / or a salt thereof based on the total weight of the polyacrylate.
  • the polyacrylate as homopolymer,
  • Copolymer or block polymer If the polyacrylate as a copolymer or
  • the monomer content of the monomer M1 in the polymer is more than 70 percent by weight, in particular more than 80 percent by weight and very particularly preferably more than 95 percent by weight based on the
  • comonomers M2 of the ⁇ , ⁇ -unsaturated carboxylic acids especially methacrylic acid (2-methylpropenoic acid), ethacrylic acid (2-ethylpropenoic acid), crotonic acid (2-butenoic acid), sorbic acid (trans-trans-2,4-hexadienoic acid), maleic acid (c / s-2-butenedioic acid) or fumaric acid (trans-2-butenedioic acid).
  • the polyacrylate is preferably present as a partially neutralized polymer, in particular the degree of neutralization should be between 20% and 90%, more preferably between 45% and 80%.
  • the absorbent body may comprise, in addition to the superabsorbent polymer, which is preferably a superabsorbent polyacrylate, a carrier material, wherein the carrier material comprises a hydrophilic fiber material.
  • hydrophilic fiber material in particular water-insoluble fibers of cellulose, in particular largely delignified technical pulp fibers, in particular
  • Wood pulp fibers in particular with a fiber length of ⁇ 5 mm find use.
  • the fibrous material may also be hydrophilic fibrous material of regenerated cellulose,
  • the absorbent body is an absorbent body surrounded by a textile sheath.
  • the shell is at least partially liquid permeable and the superabsorbent polymer is disposed therein.
  • the superabsorbent polymer is surrounded by the shell.
  • the shell may consist of a single material or comprise multiple materials.
  • the sheath can in particular consist of an interlock knit
  • Polypropylene fibers exist.
  • thermoplastic sleeves may, for example, have a round, rectangular or oval shape. However, other forms are conceivable.
  • the absorbent body can have different amounts of superabsorbent polymer and carrier material.
  • the absorbent body contains at least 10
  • Weight percent polyacrylate (based on the carrier material).
  • absorbent bodies which comprise at least 20 percent by weight, in particular at least 25 percent by weight and very particularly preferably at least 30 percent by weight polyacrylate (based on the support material).
  • the content of polyacrylate with respect to the carrier material is preferably not more than 90% by weight and in particular not more than 75% by weight.
  • the absorbent body is subjected to a solution.
  • the application is preferably to saturation and preferably with an aqueous solution which swells the superabsorbent polymer and turns it into a gelatinous state.
  • the aqueous solution is preferably saline.
  • the aqueous solution is further a synthetic solution, which is to be understood as meaning that the solution is prepared in a technical manner and does not include body fluids or body-separated fluids such as wound exudate.
  • the solution used for the application can be delivered by the absorbent body during the negative pressure therapy, wherein the solution is only partially removed irreversibly from the wound space by the applied negative pressure.
  • the absorbent may optionally absorb wound exudate and absorb bacteria and other harmful components contained therein, which counteract wound infection and further promote wound healing.
  • the absorbent body is preferably applied with less than 5000 weight percent, for example less than 3500 weight percent, for example less than 2500 weight percent of an aqueous solution.
  • the absorbent body contains that amount of an aqueous solution which corresponds to its maximum absorption capacity for Ringer's solution.
  • the maximum uptake capacity for Ringer's solution can be determined according to the aforementioned test method WSP 240.2 (05), but a) instead of the saline solution used in WSP 240.2 (05) Ringer solution is used and b) instead of the sealed in a shell test substance ("Bag" according to Section 6.1 of WSP 240.2 (05)) of the absorbent body according to the invention is used.
  • the maximum absorption capacity corresponds to the gravimetrically determined weight difference between the dry absorbent body and the applied absorbent body, wherein a deviation of the weight difference by up to 15% is included above or below.
  • the solution is a synthetic, aqueous solution, in particular Ringer's solution.
  • a Ringer's solution is meant an approximately to the blood iso-osmotic synthetic solution comprising sodium chloride, potassium chloride and calcium chloride dissolved in distilled water.
  • the Ringer solution contains 147 mmol / l sodium ions, 4.0 mmol / l potassium ions, 3.0 mmol / l calcium ions and 157 mmol / l chloride ions, whereby a deviation of the respective ion concentration from the specified value by 5% is possible ,
  • the absorbent body for example as an alternative or in addition to the aqueous solution described above, a
  • a particularly preferred polybiguanide is polyhexamethylene biguanide (PHMB or polyhexanide).
  • PHMB polyhexamethylene biguanide
  • Other suitable cationic substances with antimicrobial action are polyguanidines such as polyhexamethyleneguanidines (PHMG), / V-octyl-1 - [10- (4-octyliminopyridin-1-yl) decyl] pyridin-4-imine (octenidine), quaternary ammonium compounds, how to
  • benzalkonium chloride or cetylpyridinium chloride triazines such as 1- (3-chloroallyl) -3,5,7-triaza-1 -azoniaadamantane chloride or the ammonium compound taurolidine.
  • the airtight cover material may be in the form of, for example, a shell made of a solid material or in the form of a flexible film. Also conceivable are combinations of fixed frames or support plates with flexible films.
  • the covering material for airtight sealing of the wound comprises a water-insoluble polymer or a metal foil.
  • the water-insoluble polymer is polyurethane, polyester, polypropylene, polyethylene, polyamide or polyvinyl chloride, polyorganosiloxane (silicone), or a mixture thereof.
  • the person skilled in the art is familiar with further suitable polymeric film materials.
  • cover material and finished products can be used which have the aforementioned properties.
  • cover material and finished products can be used which have the aforementioned properties.
  • As a particularly suitable covering material for the device according to the invention has Hydrofilm ® polyurethane film (Paul
  • the device according to the invention for the negative pressure therapy of wounds furthermore comprises a means for the functional connection of the wound space with an outside of the wound space
  • Covering located vacuum source, so that a negative pressure in the wound room can be produced and liquids are sucked from the wound room.
  • negative pressure in the wound space in the context of the invention means a reduced air pressure within the wound dressing compared to the ambient air pressure (atmospheric air pressure).
  • ambient air pressure atmospheric air pressure
  • Negative pressure is often referred to as “negative pressure”. The pressure difference between the air pressure within the wound dressing and the
  • Ambient air pressure is given in the context of the invention in mm Hg (millimeter mercury column), since this is common in the field of negative pressure therapy.
  • 1 mm Hg corresponds to a torr or 133.322 Pa (Pascal).
  • the negative pressure i. the pressure difference between the air pressure within the wound dressing and the ambient air pressure, expressed as a positive value in mm Hg.
  • the negative pressure is a negative pressure of at most 250 mmHg. This negative pressure range of at most 250 mmHg has proven to be suitable for wound healing. In a preferred embodiment of the invention, the negative pressure is a negative pressure of at least 10 mm Hg and at most 150 mm Hg. As is well known in the art, the vacuum may be a constant or time varying vacuum.
  • the functional connection can be made for example with a connecting line or with a vacuum fitting.
  • Vacuum fittings are known in the art as "port”.
  • Connecting line can be passed through the cover material.
  • the at least one connecting line can be carried out under the edge of the covering material.
  • the passage point must be hermetically sealed, so that the desired negative pressure in the dressing can be maintained.
  • a sealant for example, an adhesive film, an adhesive, or an adhesive strip is suitable.
  • the connecting line is expediently at the end, which is located outside the wound dressing, via a vacuum adapter to the other
  • connection line has an opening at the end, which is located within the wound dressing.
  • the means for operatively connecting the wound space to a source of negative pressure external to the covering material is a negative pressure fitting (port) which can be fixed to one of the inside or outside of the covering material, the
  • Covering material has suitable openings. Also in this embodiment, attention must be paid to an airtight seal either the passage opening (port inside) or the support surface (port outside).
  • the seal can be made for example with an adhesive film, with an adhesive, or with an adhesive strip. It is also conceivable that the port itself has corresponding fastening devices, such as adhesive surfaces.
  • Suitable vacuum fittings are commercially available. These are typically vacuum fittings, which are on the outside of the
  • covering material and the means for the functional connection of the wound space with a vacuum source located outside the covering material are already provided ready for use connected to each other. It is very particularly preferred that this embodiment contains a film of one or more water-insoluble polymers which has a self-adhesive edge, since this arrangement substantially facilitates the application of the dressing.
  • Underpressure therapy further comprises at least one pressure distribution layer, which is introduced or introduced between the absorbent body and the covering material.
  • the advantage of an additional pressure distribution layer may be that the through the
  • Pressure distribution layer is even more evenly distributed. Furthermore, the
  • Pressure distribution layer store additional wound exudate or further improve the suction of the wound exudate from the wound room.
  • the additional pressure distribution layer may consist of an open-cell or semi-open-cell foam, a spacer fabric, a textile layer, a structured gel, or a permeable non-woven layer.
  • the open-cell or semi-open-cell foam may be polyvinyl alcohol foam,
  • Suitable textile layers include ES compresses or lattice grommets.
  • the additional pressure distribution layer may be configured to pass liquid such as wound exudate through it.
  • the pressure distribution layer may contain suitable channels or openings, or consist of a material permeable to liquids.
  • Pressure distribution layer may be adhesively or non-adherently bonded to the absorbent body. It can also be separated from the absorbent body by a further layer, for example a layer of a textile layer.
  • Underpressure therapy further comprises at least one wound contact layer which is between the Surface of the wound and the pressure distribution layer and / or between the surface of the wound and the absorbent body is introduced or is introduced.
  • the additional wound contact layer may be adhesively or non-adhesively bonded to the absorbent body or the pressure distribution layer.
  • the device for negative pressure therapy may also comprise several wound contact layers of possibly different materials.
  • any wound contact layer known from the prior art may be considered wound contact layer as long as, on the one hand, a passage of liquids through the wound contact layer is ensured and, on the other hand, the material has no tendency to coalesce or adhere to the wound tissue.
  • Wound-contact layer may be, for example, an open-cell or semi-open-cell foam, in particular polyurethane, a hydrocolloid, a structured gel
  • the device for negative pressure therapy further comprises at least one wound contact layer, which is introduced between the surface of the wound and the pressure distribution layer.
  • FIG. 1 shows an embodiment of the device according to the invention for negative pressure therapy of wounds (schematic side view).
  • FIG. 2 shows a further embodiment of the device according to the invention for negative pressure therapy of wounds, wherein the device comprises a pressure distribution layer (schematic side view).
  • FIG. 3 shows a further embodiment of the device according to the invention for negative pressure therapy of wounds, wherein the device comprises a pressure distribution layer (schematic side view).
  • FIG. 4 shows a further embodiment of the device according to the invention for negative pressure therapy of wounds, wherein the device comprises a pressure distribution layer and a wound contact layer (schematic side view).
  • FIG. 5 shows a further embodiment of the device according to the invention for negative pressure therapy of wounds, wherein the device comprises a pressure distribution layer and a wound contact layer (schematic side view).
  • Figure 1 shows an embodiment of the device according to the invention for
  • the device comprises an air-impermeable
  • the wound comprises on its surface (2), as a sensitive tissue structure deep in the intact body, a part of a bone (3) which has been brought into contact with one of the absorbent bodies (4).
  • the absorbent bodies (4) should be placed in the wound space (5) so that as few cavities as possible and good contact with the wound surface (2) and in particular the exposed bone portion (3) is ensured. The number of this
  • necessary absorbent body (4) in this embodiment depends essentially on the size of the wound space (5).
  • the covering material (1) is fastened in the area of the wound environment (6), which usually has intact skin.
  • the size of the covering material should be such that the covering material outside the wound area in the area of the
  • the cover material (1) may be in various dimensions and shapes, for example circular, oval or rectangular. It may also be present in an irregular shape adapted to the wound.
  • the cover material (1) can be an opaque material, a partially transparent material, or a completely transparent material. The use of transparent material may be advantageous to control the
  • the covering material (1) can also be a rigid material, which is applied in the form of a wound-open shell over the wound area and fastened in the region of the wound environment (6).
  • the covering material (1) must be fastened in the area around the wound environment (6) and sealed airtight. This can be done, for example, by the covering material (1) having an adhesive edge. The adhesive edge should be as far as possible until the application of the
  • an adhesive may be applied either to the edge of the cover material (1) and / or to the intact skin around the wound environment. This has the advantage that an adaptation of the covering material to the shape and size of the wound is easier.
  • An attachment and air-tight sealing of the device can also be achieved by the use of adhesive tape or adhesive.
  • the means for the functional connection of the wound space (5) to a vacuum source (10) located outside the covering material comprises, in the embodiment shown in Figure 1, a vacuum connection piece (7), which is also referred to as a "port". 7) is via a hose (8) with the
  • Vacuum unit (10) connected. Between the vacuum fitting (7) and the vacuum unit (10) is still a collecting vessel (9) for the extracted liquids.
  • the vacuum connector (7) is located in this embodiment on the side facing away from the wound outside of the air-impermeable cover material (1). To the wound space (5) with an outside of the cover material
  • vacuum unit (10) functionally, one or more through the cover material (1) passing through openings must be in this arrangement in the region of the vacuum connector (7). Furthermore, an airtight seal must be ensured.
  • Suitable vacuum fittings which usually include adhesive attachment means for attaching the port to the cover material, are commercially available, for example, the vacuum fitting "VivanoTec” port from Paul Hartmann AG, Germany.
  • FIGS. 2 and 3 Further embodiments of the device according to the invention for the negative pressure therapy of wounds are shown in FIGS. 2 and 3.
  • the device according to Figures 2 and 3 each further comprises a pressure distribution layer (1 1), which is arranged between the absorbent body (4) and covering material (1).
  • the dressing components shown in Figure 2 here also substantially the entire wound surface (2) including the exposed bone portion (3) is brought into contact with the absorbent bodies (4) and covered.
  • the variant of the device for negative pressure therapy of wounds shown in FIG. 3 in contrast to the embodiments shown in FIGS.
  • the exposed bone portion (3) has been brought into contact and covered with the absorbent body (4).
  • the absorbent body (4) covers the exposed bone portion (3) as completely as possible.
  • the absorbent body (4) is the
  • the wound space (5) is thus by the
  • Pressure distribution layer (1 1) which in this embodiment between the absorbent body (4) and the cover material (1) is arranged, substantially completely filled. In this case, the pressure distribution layer (1 1) is different from that shown in FIG.
  • Wound surface (2) which does not include a sensitive structure.
  • Pressure distribution layer (1 1) is thus also not in direct contact with the bone (3).
  • the additional pressure distribution layer (11) may be configured to pass liquid such as wound exudate through it. This can be the
  • Pressure distribution layer containing suitable channels or opening.
  • it may consist of a material which allows the passage of wound exudate without further
  • the device furthermore comprises a wound contact layer (12) which is applied to that portion of the wound surface (2) which does not comprise any sensitive structure.
  • Pressure distribution layer (1 1) is applied accordingly to the wound contact layer (12) and on the absorbent body (4).
  • the wound contact layer (12) should be such that wound exudate can pass the wound contact layer (12). It is also possible to use several wound contact layers. It can also different
  • wound contact layers are combined with each other.
  • the wound contact layer (12) may also comprise fibers or tamponade strips.
  • FIG. 5 A further embodiment of the device according to the invention for negative pressure therapy of wounds shown in FIG. 5 differs from that shown in FIG.
  • Wound surface is applied and thus the sensitive structure (exposed bone section, 3) covered.
  • the wound contact layer (12) does not prevent the absorbent body (4) from holding the bone section (3) in a moist environment.
  • TenderWet active cavity is a wound cushion saturated with Ringer's solution, which forms a shell of an interlock knit
  • the vacuum fitting is connected via a hose to a collection vessel and a vacuum unit (VivanoTec negative pressure therapy unit with secretion canister, Paul Hartmann AG, Germany). At the vacuum unit, a vacuum of 125 mmHg is set in continuous mode.
  • the components used for the wound dressing (absorbent body, pressure distribution layer,
  • Cover foil, vacuum fitting) as well as the tube and the collecting vessel are used in a sterile condition.
  • Negative pressure in the wound room The wound exudate can be sucked off and collected in the collecting vessel. If the receptacle is completely filled, it can be replaced with a new one without having to change the dressing.
  • the dressing is changed and the wound is assessed. After renewed debridement, a new wound dressing is applied as described above. This is repeated until sufficient granulation tissue has formed, so that the tendon and bone tissue is no longer exposed (medical assessment). Subsequently, the patient is prepared for a split skin transplant. Here, a thin layer of skin is removed from an intact body site of the patient. This is by a Apparatus in its area increased by a multiple and fixed as a split skin graft on the ulcer wound.
  • the negative pressure therapy is continued, wherein the suction body is not longer in use and the wound space completely with open-cell polyurethane foam (VivanoMed Foam), optionally in combination with a wound contact layer (for example Atrauman ® or Atrauman Ag ®, Paul Hartmann AG, Germany), is completed. Finally, the negative pressure therapy is stopped. The wound treatment with a hydrogel or hydrocolloid wound dressing (HydroTac ® or Hydrocoll ®, Paul Hartmann AG, Germany) continued until complete wound closure.
  • a hydrogel or hydrocolloid wound dressing Hydrogel or hydrocolloid wound dressing

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  • Health & Medical Sciences (AREA)
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  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
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  • Epidemiology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne de manière générale un corps d'aspiration pour le traitement thérapeutique d'une plaie sur le corps humain ou animal par dépression. L'invention concerne en particulier un corps d'aspiration pour le traitement thérapeutique par dépression d'une plaie qui comprend à sa surface une structure tissulaire sensible et située en profondeur dans le corps indemne comme, par exemple, un tendon ou un os.
EP13811940.9A 2012-12-21 2013-12-19 Corps d'aspiration pour le traitement thérapeutique d'une plaie par dépression Withdrawn EP2934409A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE201210025125 DE102012025125A1 (de) 2012-12-21 2012-12-21 Saugkörper zur therapeutischen Behandlung einer Wunde mittels Unterdruck
PCT/EP2013/077398 WO2014096197A1 (fr) 2012-12-21 2013-12-19 Corps d'aspiration pour le traitement thérapeutique d'une plaie par dépression

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EP2934409A1 true EP2934409A1 (fr) 2015-10-28

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US (1) US20140228786A1 (fr)
EP (1) EP2934409A1 (fr)
DE (1) DE102012025125A1 (fr)
RU (1) RU2015121868A (fr)
WO (1) WO2014096197A1 (fr)

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US8808259B2 (en) 2007-11-21 2014-08-19 T.J. Smith & Nephew Limited Suction device and dressing
WO2014024048A1 (fr) 2012-08-08 2014-02-13 Smith & Nephew Plc Appareils et procédés de traitement de plaie sur mesure destinés à être utilisés dans une thérapie de plaie par pression négative
EP3096725B1 (fr) 2014-01-21 2023-10-18 Smith & Nephew plc Appareils de traitement de plaies
GB201414146D0 (en) * 2014-08-08 2014-09-24 Medtrade Products Ltd Wound dressing
AU2017256692B2 (en) * 2016-04-26 2022-03-03 Smith & Nephew Plc Wound dressings and methods of use with integrated negative pressure source having a fluid ingress inhibition component
GB201718014D0 (en) 2017-11-01 2017-12-13 Smith & Nephew Dressing for negative pressure wound therapy with filter
DE202019101382U1 (de) * 2019-03-12 2020-06-15 Lohmann & Rauscher Gmbh Unterdruckbehandlungsanordnung

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EP0594034B1 (fr) 1992-10-22 1997-01-08 IVF Hartmann AG Compresse à déformation plastique
DE19609551C1 (de) 1996-03-12 1997-07-17 Fraunhofer Ges Forschung Biologisch degradierbare und/oder biologisch resorbierbare (Endlos)Fasern, Verfahren zu deren Herstellung und deren Verwendung als Verstärkungsfasern
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RU2015121868A (ru) 2017-01-26
US20140228786A1 (en) 2014-08-14
WO2014096197A1 (fr) 2014-06-26
DE102012025125A1 (de) 2014-06-26

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