ES2776709T3 - Apósito para heridas - Google Patents
Apósito para heridas Download PDFInfo
- Publication number
- ES2776709T3 ES2776709T3 ES17171833T ES17171833T ES2776709T3 ES 2776709 T3 ES2776709 T3 ES 2776709T3 ES 17171833 T ES17171833 T ES 17171833T ES 17171833 T ES17171833 T ES 17171833T ES 2776709 T3 ES2776709 T3 ES 2776709T3
- Authority
- ES
- Spain
- Prior art keywords
- layer
- wound
- wound dressing
- dressing apparatus
- absorbent
- 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.)
- Active
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- 239000002250 absorbent Substances 0.000 claims abstract description 57
- 230000002745 absorbent Effects 0.000 claims abstract description 57
- 230000005540 biological transmission Effects 0.000 claims abstract description 53
- 239000012530 fluid Substances 0.000 claims abstract description 46
- 210000000416 exudates and transudate Anatomy 0.000 claims abstract description 31
- 239000007788 liquid Substances 0.000 claims abstract description 22
- 238000004891 communication Methods 0.000 claims abstract description 8
- 230000000699 topical effect Effects 0.000 claims abstract description 8
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- 230000035699 permeability Effects 0.000 claims description 8
- 239000004820 Pressure-sensitive adhesive Substances 0.000 claims description 7
- 230000002209 hydrophobic effect Effects 0.000 claims description 4
- 239000004810 polytetrafluoroethylene Substances 0.000 claims description 4
- 229920001343 polytetrafluoroethylene Polymers 0.000 claims description 4
- 239000012982 microporous membrane Substances 0.000 claims description 3
- 229920006264 polyurethane film Polymers 0.000 claims description 3
- 238000005086 pumping Methods 0.000 claims description 3
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- 206010052428 Wound Diseases 0.000 description 180
- 208000027418 Wounds and injury Diseases 0.000 description 180
- 238000002560 therapeutic procedure Methods 0.000 description 19
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- 230000029663 wound healing Effects 0.000 description 3
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 2
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- HEFNNWSXXWATRW-UHFFFAOYSA-N Ibuprofen Chemical compound CC(C)CC1=CC=C(C(C)C(O)=O)C=C1 HEFNNWSXXWATRW-UHFFFAOYSA-N 0.000 description 1
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- BQCADISMDOOEFD-UHFFFAOYSA-N Silver Chemical compound [Ag] BQCADISMDOOEFD-UHFFFAOYSA-N 0.000 description 1
- 206010048038 Wound infection Diseases 0.000 description 1
- 229910021536 Zeolite Inorganic materials 0.000 description 1
- HCHKCACWOHOZIP-UHFFFAOYSA-N Zinc Chemical compound [Zn] HCHKCACWOHOZIP-UHFFFAOYSA-N 0.000 description 1
- RHJVJSBJAPQUOS-UHFFFAOYSA-N [S].[Ag].C1=CC=NN=C1 Chemical compound [S].[Ag].C1=CC=NN=C1 RHJVJSBJAPQUOS-UHFFFAOYSA-N 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- NIXOWILDQLNWCW-UHFFFAOYSA-N acrylic acid group Chemical group C(C=C)(=O)O NIXOWILDQLNWCW-UHFFFAOYSA-N 0.000 description 1
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- 239000002738 chelating agent Substances 0.000 description 1
- 238000012864 cross contamination Methods 0.000 description 1
- HNPSIPDUKPIQMN-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane Chemical compound O=[Si]=O.O=[Al]O[Al]=O HNPSIPDUKPIQMN-UHFFFAOYSA-N 0.000 description 1
- 230000009977 dual effect Effects 0.000 description 1
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- 239000011159 matrix material Substances 0.000 description 1
- 239000003771 matrix metalloproteinase inhibitor Substances 0.000 description 1
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- 239000003475 metalloproteinase inhibitor Substances 0.000 description 1
- 238000009581 negative-pressure wound therapy Methods 0.000 description 1
- 239000003921 oil Substances 0.000 description 1
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- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- 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
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/022—Adhesive bandages or dressings with fluid retention members having more than one layer with different fluid retention characteristics
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- 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
- A61F13/02—Adhesive bandages or dressings
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- A—HUMAN NECESSITIES
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- 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
- A61F13/00051—Accessories for dressings
- A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
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- A—HUMAN NECESSITIES
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- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/0206—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
-
- A—HUMAN NECESSITIES
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- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/0206—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
- A61F13/0209—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings comprising superabsorbent material
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- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0203—Adhesive bandages or dressings with fluid retention members
- A61F13/0226—Adhesive bandages or dressings with fluid retention members characterised by the support layer
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- A61F13/00—Bandages or dressings; Absorbent pads
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/025—Adhesive bandages or dressings characterised by the skin-adhering layer having a special distribution arrangement of the adhesive
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- 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
- A61F13/02—Adhesive bandages or dressings
- A61F13/0246—Adhesive bandages or dressings characterised by the skin-adhering layer
- A61F13/0253—Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the adhesive material
-
- 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]
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- 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
-
- 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
- A61M1/912—Connectors between dressing and drainage tube
-
- 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
- A61M1/96—Suction control thereof
- A61M1/962—Suction control thereof having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
-
- 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
- A61M1/98—Containers specifically adapted for negative pressure wound therapy
- A61M1/984—Containers specifically adapted for negative pressure wound therapy portable on the body
- A61M1/985—Containers specifically adapted for negative pressure wound therapy portable on the body the dressing itself forming the collection container
-
- 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
- A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
-
- 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
- A61F2013/00089—Wound bandages
- A61F2013/00246—Wound bandages in a special way pervious to air or vapours
-
- 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
- A61F2013/00089—Wound bandages
- A61F2013/0028—Wound bandages applying of mechanical pressure; passive massage
-
- 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
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7536—General characteristics of the apparatus with filters allowing gas passage, but preventing liquid passage, e.g. liquophobic, hydrophobic, water-repellent membranes
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Dermatology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Otolaryngology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
Abstract
Un aparato de apósito para heridas para uso en un sistema de presión negativa tópico (TNP) que comprende: un apósito para heridas que comprende: una capa de contacto con la herida (102) una capa absorbente (110) para absorber el exudado de la herida; una capa de transmisión (105) inferior permeable a gases y a líquidos por debajo de la capa absorbente; una capa de filtro (130) impermeable a líquidos y permeable a gases sobre la capa absorbente; una capa de transmisión (112) adicional permeable a gases y líquidos entre la capa de filtro y la capa absorbente; y una capa de cubierta (160) que comprende al menos un otificio en donde, cuando se usa, se genera una presión negativa por debajo de la capa de cubierta mediante una bomba; en donde regiones periféricas de la capa de transmisión inferior y la capa de transmisión adicional se pellizcan juntas para proporcionar caminos de comunicación de fluidos a través de los que el fluido se puede transmitir desde la capa de transmisión inferior a la capa de transmisión adicional.
Description
DESCRIPCIÓN
Apósito para heridas
La presente invención se refiere a un método y a un aparato para vendar una herida y a un método para fabricar un apósito para heridas. En particular, pero no exclusivamente, la presente invención se refiere a un apósito para heridas utilizable durante terapia de presión negativa tópica (TNP) en la que el apósito para heridas en sí mismo actúa como un contenedor de residuos para recoger y almacenar el exudado de la herida extraído de un sitio de la herida.
Existe mucha técnica anterior disponible con relación a la provisión de un aparato y métodos de uso del mismo para la aplicación de terapia de presión negativa tópica (TNP) en heridas junto con otros procesos terapéuticos destinados a mejorar los efectos de la terapia TNP. Ejemplos de tal técnica anterior incluyen los enumerados y descritos brevemente a continuación.
La terapia TNP ayuda al cierre y a la curación de heridas reduciendo el edema tisular; a fomentar el flujo sanguíneo y la granulación de tejido; a eliminar el exceso de exudados y puede reducir la carga bacteriana y, de este modo, la infección de la herida. Además, la terapia TNP permite menos perturbación externa de la herida y fomenta una curación más rápida.
En la solicitud de patente internacional WO 2004/037334 se describen un aparato, un apósito para heridas y un método para aspirar, irrigar y limpiar heridas. En términos muy generales, la aplicación describe el tratamiento de una herida mediante la aplicación de terapia TNP para aspirar la herida junto con la provisión adicional de fluido adicional para irrigar y/o limpiar la herida, cuyo fluido, que comprende tanto exudados de herida como fluido de irrigación, se extrae luego mediante los medios de aspiración y se hace circular a través de los medios para separar los materiales beneficiosos en los mismos de materiales perjudiciales. Los materiales que son beneficiosos para la curación de heridas se recirculan a través del apósito para heridas y aquellos materiales perjudiciales para la curación de heridas se descartan en una bolsa o recipiente de recogida de desechos.
En la solicitud de patente internacional WO 2005/046760 se describen un aparato, un apósito para heridas y un método para limpiar una herida usando aspiración, irrigación y limpieza de heridas. De nuevo, en términos muy generales, la invención descrita en este documento utiliza un aparato similar al del documento WO 2004/037334 con respecto a la aspiración, irrigación y limpieza de la herida, sin embargo, incluye además la etapa adicional importante de proporcionar medios de calentamiento para controlar la temperatura de ese material beneficioso que se devuelve al sitio de la herida/apósito de modo que esté a una temperatura óptima, por ejemplo, tenga el efecto terapéutico más eficaz sobre la herida. En la solicitud de patente internacional WO 2005/105180 se describen un aparato y un método para la aspiración, irrigación y/o limpieza de heridas. De nuevo, en términos muy generales, este documento describe un aparato similar a los dos documentos mencionados previamente antes mencionados, pero con la etapa adicional de proporcionar medios para el suministro y la aplicación de agentes fisiológicamente activos al sitio de la herida/apósito para fomentar la curación de la herida.
Sin embargo, el aparato y los métodos descritos anteriormente generalmente sólo son aplicables a un paciente cuando está hospitalizado, ya que el aparato usado es complejo, necesitando personas que tengan conocimientos especializados en cómo operar y mantener el aparato, y también son relativamente pesados y voluminosos, no estando adaptados para una fácil movilidad fuera de un entorno hospitalario por parte de un paciente, por ejemplo. Algunos pacientes que tienen heridas relativamente menos graves que no requieren hospitalización continua, por ejemplo, pero que, sin embargo, se beneficiarían de la aplicación prolongada de la terapia TNP, podrían ser tratados en casa o en el trabajo sujeto a la disponibilidad de un aparato de terapia TNP fácilmente transportable y fácil de mantener. Con este fin, el documento GB-A-2 307 180 describe una unidad de terapia TNP portátil que se puede transportar por un paciente y sujetar a un cinturón o a un arnés. Se puede aplicar, de este modo, una presión negativa a un sitio de la herida.
Durante la terapia TNP, una unidad de terapia portátil o no portátil genera una presión negativa en un sitio de la herida. Como se elimina fluido, incluyendo aire, así como el material de exudado de la herida, del sitio de la herida, éste se debe recoger de alguna manera remota del sitio de la herida. Con unidades de terapia conocidas anteriores la recogida y el almacenamiento de material de exudado de la herida se lleva a cabo típicamente mediante un contenedor de desechos conectado a una unidad de bombeo de la unidad de terapia. El uso de un contenedor, sin embargo, puede dar como resultado que el aparato de la unidad de terapia en sí mismo sea bastante voluminoso y costoso de fabricar. También sustituir un contenedor o una bolsa en un contenedor en el que se recoge el exudado de la herida puede llevar mucho tiempo y ser un proceso relativamente antihigiénico.
Las unidades de terapia conocidas anteriores también suelen incluir una bomba que se usa para generar la presión negativa. Tales bombas pueden ser costosas de fabricar y son relativamente pesadas.
El documento WO 2007/030601 describe un apósito para heridas autónomo con una microbomba. La bomba para arrastrar fluido de la herida hacia una zona de vacío se incluye en un apósito para heridas en sí mismo. Sin embargo, el exudado de la herida del apósito sólo se puede extraer a través de una serie compleja de etapa. El
proceso de extracción del exudado también es propenso a la contaminación, dado que una vez que una capa absorbente está completamente saturada con exudado de la herida, se debe abrir una puerta de acceso en el apósito de la herida de modo que la se puedan extraer la capa absorbente y la microbomba. Se apreciará que tal extracción de exudado y extracción de bomba pueden llevar mucho tiempo y pueden conducir a una contaminación cruzada entre usuarios. Un problema adicional es que el apósito de la herida es propenso a expansión excesiva y ruptura.
El documento CA 2 586 650 A1 describe un aparato de apósito de herida para uso en un sistema de presión negativa tópico, en donde el exudado se recoge y se almacena en el apósito de herida.
Es un objetivo de la presente invención mitigar, al menos en parte, los problemas mencionados anteriormente. Es un objetivo de ciertas realizaciones de la presente invención proporcionar un método para proporcionar presión negativa en un sitio de la herida para ayudar al cierre y la curación de la herida en el cual el exudado de la herida arrastrado desde un sitio de la herida durante la terapia se recoge y almacena en un apósito para heridas.
Es un objetivo de ciertas realizaciones de la presente invención proporcionar un apósito para heridas que sea capaz de ser colocado sobre un sitio de la herida y que incluya una bomba integrada para generar presión negativa en el sitio de esa herida. También para ciertas realizaciones, el apósito para heridas puede recoger cualquier exudado de la herida.
La invención es como se define en las reivindicaciones.
Según un primer aspecto de la presente descripción, se proporciona un aparato para vendar una herida, que comprende:
una capa absorbente para absorber el exudado de la herida;
una capa de filtro impermeable a líquidos y permeable a gases sobre la capa absorbente; y
una capa de cubierta que comprende al menos un orificio; en donde la capa absorbente está en comunicación de fluidos con la capa de filtro;
De acuerdo con un segundo aspecto de la presente descripción se proporciona un método de aplicación de presión negativa tópica (TNP) al sitio de la herida que comprende las etapas de:
bombear el exudado de la herida y el aire desde un sitio de la herida, siendo una región periférica alrededor del sitio de la herida sellada con un apósito para heridas;
recoger el exudado de la herida, bombeado desde el sitio de la herida en una capa absorbente del apósito para heridas; y
expulsar gas a través de al menos un orificio en una capa de cubierta del apósito para heridas y una capa de filtro en comunicación de fluidos con la capa absorbente.
Ciertas realizaciones de la presente invención proporcionan la ventaja de que un apósito para heridas desechable se puede fijar sobre un sitio de la herida y se puede usar simultáneamente para proporcionar presión negativa en el sitio de la herida y recoger y almacenar el exudado de la herida.
La presente invención proporciona la ventaja de que no se requiere una unidad de terapia separada para generar presión negativa en un sitio de la herida y para recoger y almacenar cualquier exudado de la herida. Más bien un apósito para heridas puede llevar a cabo un proceso tanto de bombeado como de recogida del exudado de la herida. El apósito para heridas puede ser entonces un artículo de un sólo uso que se puede desechar posterior a su uso. Esto reduce el riesgo de contaminación.
Ciertas realizaciones de la presente invención proporcionan la ventaja de que un apósito para heridas se puede usar para recoger el exudado de la herida generado durante un proceso de terapia de presión negativa. Una bomba remota del apósito para heridas se puede conectar al apósito para heridas y reutilizar, mientras que el apósito para heridas en sí mismo se usa para recoger el exudado de la herida y se puede desechar entonces después de su uso. Se describirán ahora en lo sucesivo realizaciones de la presente invención, a modo de ejemplo solamente, con referencia a los dibujos adjuntos, en los que:
La Figura 1 ilustra un apósito para heridas;
La Figura 2 ilustra una vista superior de un apósito para heridas;
La Figura 3 ilustra una parte del apósito para heridas;
La Figura 4 ilustra una vista de despiece de un apósito para heridas con una bomba montada; y
La Figura 5 ilustra una vista de una sección horizontal a través de un apósito para heridas.
En los dibujos, números de referencia iguales se refieren a partes similares.
La Figura 1 ilustra una sección transversal a través de un apósito 100 para heridas según una realización de la presente invención. Una vista en planta desde arriba del apósito 100 para heridas se ilustra en la Figura 2 con la línea A-A indicando la ubicación de la sección transversal mostrada en la Figura 1. Se entenderá que la Figura 1 ilustra una vista esquemática generalizada de un aparato 100. Se entenderá que las realizaciones de la presente invención son generalmente aplicables para su uso en sistemas de presión negativa tópica (TNP). En resumen, la terapia de heridas por presión negativa ayuda al cierre y la curación de muchas formas de heridas “difíciles de curar” reduciendo el edema tisular; favoreciendo el flujo sanguíneo y la formación de tejido granular; eliminando el exceso de exudado y reduciendo la carga bacteriana (y de este modo el riesgo de infección). Además, la terapia permite menos perturbación de una herida conduciendo a una curación más rápida.
El apósito 100 para heridas se puede situar sobre el sitio de la herida a ser tratada. El apósito 100 forma una cavidad sellada sobre el sitio de la herida. Opcionalmente, se puede usar un envasador de heridas dentro de una cavidad de la herida por debajo del apósito. Acertadamente, el material de envasador puede ser un material de gasa o espuma PU reticulada.
Se prevé que el intervalo de presión negativa para el aparato que incorpora la presente invención puede estar entre alrededor de -50 mmHg y -200 mmHg (obsérvese que estas presiones son relativas a la presión atmosférica normal, de este modo, -200 mmHg serían aproximadamente 560 mmHg en términos prácticos). Acertadamente el intervalo de presión puede estar entre alrededor de -75 mmHg y -150 mmHg. Alternativamente, se puede usar un intervalo de presión de hasta -75 mmHg, hasta 80 mmHg o por encima de -80 mmHg. También, acertadamente, se podría usar un intervalo de presión de por debajo de 75 mmHg. Alternativamente, se podría usar un intervalo de presión de por encima de -100 mmHg o por encima de -150 mmHg.
Como se ilustra en la Figura 1, una superficie 101 inferior del apósito 100 para heridas está provista con una capa 102 de contacto con la herida. La capa 102 de contacto con la herida puede ser una capa de poliuretano o una capa de polietileno u otra capa flexible que esté perforada, por ejemplo, a través de un proceso de perno caliente o de alguna otra forma, o de otra forma hecha permeable a líquido y gas. La capa de contacto con la herida tiene una superficie 101 inferior y una superficie 103 superior. Las perforaciones 104 son agujeros pasantes en la capa de contacto con la herida que permiten que un fluido fluya a través de la capa. La capa de contacto con la herida ayuda a prevenir el encarnado de tejido en el otro material del apósito para heridas. Las perforaciones son lo suficientemente pequeñas para cumplir con este requisito, pero aun así dejan pasar fluido. La capa de contacto con la herida también ayuda a mantener todo el apósito para heridas junto y actúa como un portador para una capa adhesiva superior (no mostrada) y una inferior opcional. Por ejemplo, se puede proporcionar un adhesivo sensible a la presión inferior en la superficie 101 del envés del apósito para heridas, mientras que se puede proporcionar una capa adhesiva sensible a la presión superior en la superficie 103 superior de la capa de contacto con la herida. El adhesivo sensible a la presión que puede ser un adhesivo a base de silicona o acrílico u otros tales adhesivos se pueden formar en ambos lados u opcionalmente en uno seleccionado o ninguno de los lados de la capa de contacto con la herida. Cuando se utiliza una capa de adhesivo sensible a la presión inferior, esto ayuda a adherir el apósito para heridas a la piel alrededor del sitio de la herida.
Una capa 105 de material poroso tal como una capa de espuma o similar está situada por encima de la capa de contacto con la herida. Esta capa porosa permite la transmisión de fluido, incluyendo líquido y gas, lejos del sitio de la herida hacia las capas superiores del apósito para heridas. La capa 105 también ayuda a distribuir la presión generada por una bomba, mencionada con más detalle a continuación, de modo que todo el sitio de la herida vea una presión negativa igualada. Espuma reticulada o un material no tejido que podría ser natural o sintético se puede usar como el material poroso de la capa 105 porosa.
Se proporciona una capa 110 de material absorbente por encima de la capa 105 de transmisión. El material absorbente que puede ser una espuma o un material natural o sintético no tejido y que opcionalmente puede incluir o ser un material superabsorbente forma un depósito para el fluido, particularmente líquido, eliminado del sitio de la herida. El material de la capa absorbente también evita que el líquido recogido en el apósito para heridas fluya de una manera que salpique. La capa absorbente 130 también ayuda a distribuir fluido en toda la capa a través de una acción de mecha, de modo que el fluido se arrastre desde el sitio de la herida y se almacene en toda la capa absorbente. Esto evita la aglomeración en áreas de la capa absorbente. Dado que, en uso, la capa absorbente experimenta presiones negativas, el material de la capa absorbente se elige para absorber líquido bajo tales circunstancias. Un material superabsorbente es un ejemplo de tal material. Se puede utilizar, no obstante, material no superabsorbente incluso cuando se prevén presiones negativas significativas. El material de la capa absorbente no necesita ser hidrófilo. Acertadamente, se puede usar un material con vacíos abiertos conectivos. Acertadamente se usa un material que puede resistir la fuerza de compresión de la presión negativa, por ejemplo, espuma precomprimida FT11M fabricada por Foam Techniques. Acertadamente se selecciona el material absorbente de modo que se evita que el fluido se drene hacia atrás cuando se extrae el apósito. Se ha de observar que si se usa un superabsorbente, tal material es capaz de expandirse contra la fuerza de compresión de la presión negativa.
Una capa 112 adicional de material poroso, tal como una capa de espuma o similar, está situada por encima de la capa 110 absorbente. Esta capa porosa permite la transmisión de fluido, incluyendo líquido y gas que se alejan de un sitio de la herida hacia las capas superiores del apósito para heridas. La capa 112 también ayuda a distribuir la presión generada por una bomba, mencionada con más detalle a continuación, de modo que todo el sitio de la herida vea una presión negativa igualada. Una espuma reticulada o un material no tejido que podría ser natural o sintético se puede usar como material poroso de la capa 112 porosa. El material puede ser el mismo o diferente de la capa 105 de material poroso anteriormente mencionada.
Se proporciona una capa 130 de filtro sobre la capa 110 absorbente. La capa de filtro permite que la atraviese vapor de humedad y gas, pero no líquido. Un material adecuado para el material de filtro de la capa 130 de filtro es PTFE expandido GoreTM de 0,2 micras de la gama MMT. También se pueden usar tamaños de poros más grandes, pero éstos pueden requerir una capa de filtro secundaria para asegurar la contención completa de la carga biológica. Como el fluido de la herida contiene lípidos, es preferible, aunque no esencial, usar una membrana de filtro oleófila, por ejemplo, MMT-332 de 1,0 micras antes de MMT-323 de 0,2 micras. Esto evita que los lípidos bloqueen el filtro hidrófilo.
Se entenderá que se podrían usar otros tipos de material para la capa de filtro. De manera más general, se puede usar una membrana microporosa que sea una lámina delgada y plana de material polimérico, que contiene miles de millones de poros microscópicos. Dependiendo de la membrana elegida, estos poros pueden oscilar de tamaño desde 0,01 hasta más de 10 micrómetros. Las membranas microporosas están disponibles en formas tanto hidrófilas (filtrado de agua) como hidrófobas (repelentes de agua). Acertadamente el apósito 100 para heridas según ciertas realizaciones de la presente invención usa membranas hidrófobas microporosas (MHM). Se pueden emplear numerosos polímeros para formar las MHM. Por ejemplo, PTFE, polipropileno, PVDF y copolímero acrílico. Todos estos polímeros opcionales se pueden tratar con el fin de obtener características específicas de la superficie que puede ser tanto hidrófoba como oleófila. Como tales, repelerán los líquidos con bajas tensiones superficiales, tales como infusiones multivitamínicas, lípidos, surfactantes, aceites y disolventes orgánicos.
Las MHM bloquean los líquidos al tiempo que permiten que el aire fluya a través de las membranas. También son filtros de aire altamente eficientes que eliminan aerosoles y partículas potencialmente infecciosos. Una única pieza de MHM es bien conocida como opción para sustituir válvulas mecánicas o respiraderos. La incorporación de las MHM puede reducir de este modo los costos de ensamblaje del producto mejorando las ganancias y la relación coste/beneficio para un paciente.
La capa 130 de filtro permite de este modo que el gas sea expulsado hacia arriba a través del apósito para heridas. Líquido, partículas y patógenos, sin embargo, se contienen en el apósito.
Una capa 140 de sellado impermeable a gases se extiende a lo ancho del apósito para heridas. La capa de sellado que puede ser, por ejemplo, una película de poliuretano que tiene un adhesivo sensible a la presión en ambos lados es impermeable a gases y, de este modo, esta capa opera para sellar una cavidad de la herida sobre la cual se coloca el apósito para heridas. De esta forma, se crea una cámara eficaz debajo de la capa de sellado y entre la capa de sellado y un sitio de la herida donde se puede establecer una presión negativa. La capa 140 de sellado está sellada a la capa 130 de filtro. Por ejemplo, a través de adhesivo o técnicas de soldadura. El gas que sale del apósito pasa, de este modo, a través de la capa de filtro y la capa de sellado.
Acertadamente el material de la capa de sellado puede tener una alta permeabilidad al vapor de humedad, por ejemplo, Elastollan (nombre comercial) SP9109 fabricado por BASF. Opcionalmente, se puede usar un adhesivo acrílico con un patrón de puntos para ayudar a mejorar la permeabilidad al vapor de humedad. Una ventaja de usar un material de alta permeabilidad al vapor de humedad como la capa 160 de sellado es que la capacidad de manejo del fluido del apósito se puede aumentar significativamente por la acción de la humedad que transpira a través de la película y que se dispersa a la atmósfera. Ventajosamente, las tasas de transpiración se pueden lograr fácilmente del orden de 3000 gramos/centímetro cuadrado/24 horas como resultado de la humedad alta la lograda en el apósito y el contacto íntimo del material logrado durante el uso del aparato a una presión negativa de hasta 250mmHg por debajo de la presión atmosférica.
Como se ilustra en la Figura 1, se proporciona una agrupación de rejilla de los agujeros pasantes 141 en la capa de sellado. Esto permite que el fluido, incluyendo gas y líquido, pase a través de la capa 140 de sellado. Alternativamente, cuando se usan una capa de cubierta y una capa de sellado separadas, la capa de sellado puede extenderse solamente alrededor de un área circunferencial de las capas subyacentes donde se sella entre una capa externa (mencionada a continuación con más detalle) y la capa de filtro. Como resultado, cualquier gas que salga del sitio de la herida debe salir a través de la capa de filtro. El líquido se retiene en las capas por debajo de la capa de filtro.
Una capa 150 de material poroso, tal como una capa de espuma o similar, está situada por encima la capa 140 de sellado. Esta capa porosa permite la transmisión de fluido incluyendo líquido y gas lejos de un sitio de la herida. La capa 150 también ayuda a distribuir la presión generada por una bomba, mencionada con más detalle a continuación, de modo que todo el sitio de la herida vea una presión negativa igualada. Espuma reticulada o un material no tejido que podría ser natural o sintético se puede usar como el material poroso de la capa 150. El material puede ser igual o diferente del material de las capas 105, 112 subyacentes.
Una capa 160 de cubierta cubre la capa absorbente del apósito 100 para heridas. La capa de cubierta que, por ejemplo, puede ser una película de poliuretano, actúa como barrera bacteriana y ayuda a retener el líquido dejando de ensuciar. La capa de cubierta también proporciona integridad al apósito y es impermeable al vapor de humedad y a gases. La capa de cubierta ayuda a mantener el apósito de la herida junto, proporcionando, de este modo, integridad estructural. Una superficie 171 superior también presenta una superficie sin suciedad libre de bacterias. Como alternativa el material de la capa de cubierta puede tener una alta permeabilidad al vapor de humedad, por ejemplo, Elastollan (nombre comercial) SP9109 fabricado por BASF. Opcionalmente, se puede usar un adhesivo acrílico con patrón de puntos para ayudar a mejorar la permeabilidad al vapor de la humedad. Una ventaja de usar un material de alta permeabilidad al vapor de humedad como la capa 160 de cubierta es que la capacidad de manejo del fluido del apósito se puede aumentar significativamente por la acción de la humedad que transpira a través de la película y que se dispersa a la atmósfera. Ventajosamente, se pueden lograr fácilmente tasas de transpiración del orden de 3000 gramos/centímetro cuadrado/24 horas como resultado de la alta humedad lograda en el apósito y el contacto íntimo del material logrado durante el uso del aparato a una presión negativa de hasta 250mmHg por debajo de la presión atmosférica.
Una única abertura 165 formada como un único agujero o una disposición cerrada de agujeros está formada en una región central de la capa de cubierta superior. La abertura 165 está en comunicación de fluidos con una entrada a una bomba 170 que está montada en la superficie 171 superior de la capa de cubierta. En operación, la bomba 170 bombea fluido a través del apósito para heridas desde un sitio de la herida por debajo de la capa 102 de contacto con la herida hacia arriba a través de la primera capa 105 de transmisión, la capa 110 absorbente, la capa 112 de transmisión adicional, la capa 130 de filtro, la capa 140 de sellado y la capa 150 de transmisión adicional.
Volviendo a la Figura 2, que ilustra un apósito 100 para heridas según una realización de la presente invención, uno puede ver la superficie 171 superior de la capa 170 de cubierta que se extiende radialmente hacia afuera lejos de un centro del apósito hacia una región 200 de borde que rodea una región 201 elevada central superpuesta a las capas de espuma y la capa 110 del absorbente. La Figura 2 también ayuda a ilustrar la ubicación de la bomba 170 en la capa de cubierta. Como se indica en la Figura 2, la forma general del apósito para heridas es un cuadrado que tiene las longitudes de los lados iguales con las regiones 202 de las esquinas redondeadas. Se apreciará que los apósitos para heridas según otras realizaciones de la presente invención pueden estar formados de manera diferente, tal como apósitos rectangulares, circulares o elípticos.
La Figura 3 ilustra una vista ampliada de la región 200 de borde del apósito 100 para heridas ilustrado en las Figuras 1, 2 y 3. Como se ve, la capa 160 de cubierta se extiende sobre la capa 150 de transmisión de espuma hacia una región de borde. Aquí, la capa de cubierta se asegura a la capa 140 de sellado y la capa 102 de contacto con la herida. La Figura 3 también ayuda a ilustrar cómo las perforaciones 104 en la capa 102 de contacto con la herida se extienden alrededor de la capa 105 de espuma y la capa 110 absorbente. Se observará que un espacio 301 se indica en la Figura 3 debajo de la capa 140 de sellado y por encima de la capa 102 de contacto con la herida y los extremos de las capas 105, 112 de transmisión y la capa 110 absorbente. El espacio 301 se muestra solamente por razones ilustrativas y, en la práctica, las capas de transmisión y las capas absorbentes estarán algo biseladas para reducir el espacio. Un espacio 302 adicional se ilustra del mismo modo en la Figura 3 por encima de la capa de sellado y por debajo de la superficie interior de la capa de cubierta. De nuevo, esto se incluye solamente por ilustración y, en la práctica, estos espacios se evitarán debido a un proceso de pellizcado en el método de fabricación. También se apreciará por los expertos en la técnica que cuando se ponga en uso, el apósito para heridas se someterá a una presión negativa dentro de una región definida por la superficie interna de la capa de cubierta. Tal presión negativa tenderá a colapsar cualquier espacio restante.
La capa de contacto con la herida según las realizaciones de la presente invención es porosa al agua y se enfrenta a un sitio de la herida subyacente. Una capa 105 porosa inferior, tal como una capa de espuma PU reticulada, se usa para distribuir la extracción de gas y fluido, de manera que todas las áreas de una herida se sometan a igual presión. La capa de sellado junto con la capa de filtro forma un sellado sustancialmente estanco a líquidos sobre la herida. De este modo a medida que la bomba 170 bombea se genera una presión negativa por debajo de la capa de sellado. Esta presión negativa se experimenta de este modo en el sitio de la herida objetivo. El fluido, incluyendo aire y exudado de la herida, se arrastra a través de la capa de contacto con la herida y la capa 105 de espuma reticulada. El exudado de la herida arrastrado a través de las capas inferiores del apósito para heridas se disipa y se absorbe en la capa absorbente donde se recoge y almacena. El aire y el vapor de humedad se arrastran hacia arriba a través del apósito para heridas a través de la capa 112 de transmisión intermedia y a través de la capa de filtro y la capa de sellado. La capa de filtro y la capa de sellado se aseguran entre sí para evitar un movimiento hacia arriba a través del apósito de la herida de cualquier cosa distinta de vapor de humedad y aire. Este aire y vapor de humedad se arrastran hacia arriba por la bomba 170 hacia la entrada 300 de fluido. La bomba expulsa el fluido como aire y vapor de humedad a través de una salida de fluido (no mostrada).
El uso de la capa 150 de transmisión superior y la capa 160 de cubierta es útil durante el uso de orientación múltiple cuando partes de la capa de filtro podrían llegar a ser ocluidas de otro modo.
Aún como opciones adicionales, el apósito puede contener antimicrobianos, por ejemplo, agentes nanocristalinos de plata en la capa de contacto con la herida y/o diazina de sulfuro de plata en la capa absorbente. Éstos se pueden usar por separado o juntos. Éstos matan respectivamente microorganismos en la herida y microorganismos en la
matriz de absorción. Como una opción adicional más, se pueden incluir otros componentes activos, por ejemplo, supresores del dolor, tales como ibuprofeno. También se podrían utilizar agentes que mejoran la actividad celular, tales como factores de crecimiento o que inhiben enzimas, tales como inhibidores de la metaloproteinasa de matriz, tales como inhibidores tisulares de la metaloproteinasa (TIMPS) o quelantes de zinc. Como una opción adicional más, elementos que atrapan el olor, tales como carbón activado, ciclodextrina, zeolita o similares se pueden incluir en la capa absorbente o como una capa adicional por encima de la capa de filtro.
La Figura 4 ilustra una vista de despiece del apósito para heridas ilustrado en las Figuras 1, 2 y 3. Como se ilustra en la Figura 4, la capa más baja del apósito para heridas es una capa 102 de contacto con la herida perforada. Se apreciará que antes de usar una capa protectora aún más baja se puede asegurar a la superficie 101 inferior de la capa de contacto con la herida. El papel protector (no mostrado) se retira inmediatamente antes de la aplicación del apósito para heridas sobre el sitio de la herida. Durante la fabricación, una región 400 central de la capa 102 de contacto con la herida se hace ligeramente cóncava para proporcionar una superficie 103 superior aplanada para la capa de contacto con la herida.
Una capa 105 de transmisión está situada debidamente en la región 400 central aplanada de la capa de contacto con la herida. La capa de espuma incluye una región 401 de base sustancialmente rectangular junto con una agrupación de columnas 402 verticales. Como se ilustra en la Figura 4, se puede usar una agrupación de 8 x 8 columnas 402. Se apreciará que se pueden utilizar otros números de columnas. Las columnas 402 tienen una sección transversal sustancialmente circular, aunque se apreciará que se podrían usar elementos de columna que tienen diferentes formas de sección transversal. Los elementos de columna 402 y la sección 402 de base están formados acertadamente de manera integral, aunque éstos se podrían formar por separado, con los elementos de columna estando asegurados a la sección de base de alguna forma apropiada tal como a través de técnicas de adhesivo.
La capa 110 absorbente está situada por encima de la capa 105 de transmisión. La capa 110 absorbente es una capa de material absorbente e incluye agujeros pasantes 403 formados en un bloque 404 sustancialmente rectangular de material absorbente. Los agujeros pasantes se establecen en una agrupación de 8 x 8 para coincidir con las columnas 402 verticales en la capa de transmisión subyacente. Se apreciará que el número y el patrón de agujeros pasantes 403 se seleccionan para cuadrar con la forma, el número y la disposición de las columnas.
La capa 112 de transmisión intermedia es una sección 405 de base sustancialmente rectangular de material poroso tal como espuma reticulada con una agrupación de columnas 406 que se extienden hacia abajo desde una superficie inferior de la base 405. Las columnas 406 coinciden con ubicaciones de los agujeros pasantes 403 en la capa absorbente. Se apreciará que las columnas 406 de la capa 112 de transmisión intermedia se pueden formar integralmente con la parte 405 de base de la capa de transmisión o se pueden asegurar de alguna forma a la misma. La altura de las columnas 402, 406 de las capas de transmisión inferior e intermedia respectivamente es tal que una superficie de contacto superior de las columnas 402 de la capa de transmisión inferior y una superficie de contacto inferior de las columnas 406 de la capa de transmisión intermedia entran en contacto cuando se coloca el apósito para heridas junto.
De este modo, éstos proporcionan caminos de transmisión de fluido a través de la capa absorbente, de modo que fluido, incluyendo aire y exudado de la herida y líquido, se arrastra desde la región inferior hacia arriba a través de la capa absorbente cuando la bomba 170 está funcionando.
Una capa rectangular de material 130 de filtro está situada por encima de la superficie superior de la sección 405 de base de la capa de transmisión intermedia. La capa de filtro bloquea el movimiento a través de la misma del líquido. La capa de filtro es acertadamente una lámina de PTFE expandido GoreTM de 0,2 micras.
Una capa 140 de sellado está situada sobre la capa 130 de filtro. La capa de sellado tiene una región de borde y una región 407 central generalmente cóncava. El envés de la capa 140 de sellado está de este modo rebajada. Una agrupación de aberturas establecida en una agrupación de rejilla de 5 x 5 se crea a través de la capa 140 de sellado. La capa de sellado lejos de las aberturas es estanca a gases y fluidos. Si se usa opcionalmente un material que tiene una alta permeabilidad al vapor de humedad, entonces la capa de sellado será, por supuesto, permeable al vapor de humedad. El fluido, que incluye líquido y gas, por supuesto, puede penetrar a través de las perforaciones. La capa 130 de filtro que está asegurada en el envés de la capa de sellado, sin embargo, evita la penetración de líquido a través de las aberturas y, en cierta medida, evita la penetración de aire a través de las aberturas. El vapor de humedad puede penetrar a través de las aberturas.
Una capa de transmisión superior formada como una lámina de espuma reticulada está situada sobre la región central de la superficie superior de la capa 140 de sellado. La capa de transmisión superior actúa como un colector y un difusor para ayudar a propagar la presión negativa generada por la bomba 170.
Una capa 160 de cubierta está situada sobre la capa de sellado y la capa 150 de transmisión superior. La capa de cubierta tiene una región 200 de borde y una región 201 elevada central. El envés de la capa de cubierta de este modo presenta una región aplanada central para recibir la capa de transmisión superior, la región central elevada de la capa de sellado y la capa de filtro, la capa de transmisión intermedia, la capa absorbente y la capa de transmisión
inferior. Una abertura 165 central está hecha en el centro de la superficie superior de la capa de cubierta. La abertura 165 central se sitúa coincidiendo con una entrada 300 de fluido de la bomba 170. De este modo, en uso, cuando una bomba 170 está en uso, se genera una presión negativa debajo de la cubierta 160. Esta presión negativa se distribuye en todo el apósito para heridas y en un sitio de la herida objetivo situado debajo de la capa de contacto con la herida. A medida que se establece y mantiene la presión negativa, el exudado de la herida y el aire se arrastran hacia arriba lejos del sitio de la herida a través del apósito para heridas. El líquido y el aire se arrastran hacia arriba a través de la capa de contacto con la herida hacia la base de la capa 105 de transmisión inferior y hacia arriba a través de las columnas de conexión en la capa de transmisión inferior y la capa de transmisión intermedia. Se apreciará, por supuesto, que las columnas que tienen una altura suficiente para abarcar la totalidad de la capa absorbente se podrían proporcionar o bien en la superficie superior de la capa 105 de transmisión inferior o bien en la superficie inferior de la capa 112 de transmisión intermedia. Alternativamente, las aberturas 403 en la capa absorbente se pueden rellenar con material transmisivo, tal como cilindros de espuma, cuando se fabrica el apósito para heridas. Cualquier exudado de la herida que se arrastra hacia arriba a través del apósito para heridas se disipa hacia afuera del material absorbente en las regiones de abertura de la capa absorbente. De este modo, el líquido se recoge y se almacena en la capa absorbente. El aire y el vapor de humedad continúan hacia arriba a través de la capa 130 de filtro y la capa 140 de sellado y se evacúan por la bomba 170.
La Figura 5 ilustra una sección transversal horizontal a través del apósito para heridas que ilustra una superficie 404 superior de la capa absorbente que incluye las aberturas 403. Cada una de las aberturas 403 está llena de material absorbente tal como las columnas 402 de la capa intermedia inferior.
Se apreciará que, según la presente invención, los caminos de comunicación de fluidos a través de los cuales se puede transmitir fluido desde la capa de transmisión inferior hasta la capa de transmisión intermedia se hacen pellizcando entre sí regiones periféricas de las regiones inferior e intermedia. De este modo, la transmisión de fluido seguiría alrededor de los bordes periféricos del apósito para heridas. Tales caminos de fluido pueden sustituir los caminos de fluido formados por las columnas que pasan a través de las aberturas en la capa absorbente o, alternativamente, pueden tomar el lugar de tales etapas. Esto maximizaría la cantidad de material absorbente en la capa 110 en el apósito para heridas resultante.
Se ha de observar que, según otras ciertas realizaciones de la presente invención, se puede montar una bomba remota en una región de borde del apósito para heridas en lugar de sobre la superficie superior. En tal caso, los tubos se pueden conectar directamente a la bomba. Posterior a un solo uso, el apósito para heridas y la bomba se pueden desechar, de este modo. Como opción, los tubos pueden estar provistos de un conector de ajuste de clic u otro conector de ajuste fácil que se pueden conectar a los correspondientes conectores de acoplamiento a través de los tubos correspondientes a una bomba remota. De esta forma una bomba remota se puede reutilizar mientras el apósito para heridas en sí mismo incluyendo los tubos de conexión y los conectores, es desechable después de un solo uso.
Se apreciará que, alternativamente, los tubos se podrían proporcionar mediante un solo tubo de lumen doble. Como una alternativa adicional más, los tubos se pueden proporcionar mediante un solo tubo de bucle continuo, pasando el tubo entonces a través de rodillos de presión para una bomba peristáltica.
Se entenderá que para las realizaciones de la presente invención que incluyen una bomba montada en la capa de cubierta o en un área de borde periférico del apósito, se pueden incluir una fuente de potencia integral y circuitería de control. Alternativamente la fuente de potencia puede ser externa a la bomba y estar montada remotamente. Una fuente de potencia y/o circuitería de control remota mejora la capacidad de desechado del apósito y permite recargar la batería si se usan baterías de repuesto.
Se ha de señalar que, en uso, el apósito se puede usar “del revés”, en ángulo o vertical. Las referencias a la parte superior y la parte inferior se usan, de este modo, con propósitos de explicación solamente.
Cuando se utilizan una capa de cubierta y una capa de sellado separadas, tales capas se pueden fabricar a partir de los mismos o diferentes materiales.
En toda la descripción y las reivindicaciones de esta especificación, las palabras “comprenden” y “contienen” y las variaciones de las palabras, por ejemplo “comprendiendo” y “comprende”, significan “que incluyen, pero no se limitan a”, y no están destinadas a excluir (y no excluyen) otros restos, aditivos, componentes, enteros o etapas.
En toda la descripción y las reivindicaciones de esta especificación, el singular abarca el plural a menos que el contexto lo requiera de otro modo. En particular, donde se usa el artículo indefinido, se ha de entender la especificación como que contempla la pluralidad, así como la singularidad, a menos que el contexto lo requiera de otro modo.
Los rasgos, los números enteros, las características, los componentes, los restos químicos o los grupos descritos junto con un aspecto, una realización o un ejemplo particular de la invención han de ser entendidos que son aplicables a cualquier otro aspecto, realización o ejemplo descrito en la presente memoria, a menos que sean incompatible con los mismos.
Claims (21)
1. Un aparato de apósito para heridas para uso en un sistema de presión negativa tópico (TNP) que comprende: un apósito para heridas que comprende:
una capa de contacto con la herida (102)
una capa absorbente (110) para absorber el exudado de la herida;
una capa de transmisión (105) inferior permeable a gases y a líquidos por debajo de la capa absorbente; una capa de filtro (130) impermeable a líquidos y permeable a gases sobre la capa absorbente;
una capa de transmisión (112) adicional permeable a gases y líquidos entre la capa de filtro y la capa absorbente; y
una capa de cubierta (160) que comprende al menos un otificio en donde, cuando se usa, se genera una presión negativa por debajo de la capa de cubierta mediante una bomba;
en donde regiones periféricas de la capa de transmisión inferior y la capa de transmisión adicional se pellizcan juntas para proporcionar caminos de comunicación de fluidos a través de los que el fluido se puede transmitir desde la capa de transmisión inferior a la capa de transmisión adicional.
2. El aparato de apósito para heridas de la reivindicación 1, en donde la capa de cubierta comprende un material que tiene una permeabilidad al vapor de humedad elevada.
3. El aparato de apósito para heridas de la reivindicación 1, en donde la capa de cubierta es una película de poliuretano.
4. El aparato de apósito para heridas según cualquier reivindicación anterior, en donde la capa de cubierta comprende una única abertura formada como un único agujero en una región central de la capa de cubierta.
5. El aparato de apósito para heridas según cualquier reivindicación anterior, en donde la capa absorbente incluye material superabsorbente.
6. El aparato de apósito para heridas según la reivindicación 1 o la reivindicación 2, que además comprende una capa protectora liberable sobre una superficie inferior de la capa de contacto con la herida.
7. El aparato de apósito para heridas según cualquier reivindicación anterior, que además comprende un adhesivo sensible a la presión inferior que se proporciona sobre la superficie del envés del apósito para heridas.
8. El aparato de apósito para heridas según la reivindicación 6, que además comprende un adhesivo sensible a la presión superior sobre una superficie superior de la capa de contacto con la herida.
9. El aparato de apósito para heridas según la reivindicación 1, en donde la forma general del apósito para heridas comprende un cuadrado que tiene las longitudes de los lados iguales con las regiones de las esquinas redondeadas.
10. El aparato de apósito para heridas según cualquier reivindicación anterior, en donde la capa de filtro es una membrana microporosa.
11. El aparato de apósito para heridas según cualquier reivindicación anterior, en donde la capa de filtro es una membrana microporosa hidrófoba.
12. El aparato de apósito para heridas según cualquier reivindicación anterior, en donde la capa de filtro comprende PTFE.
13. El aparato de apósito para heridas según cualquier reivindicación anterior, en donde el apósito para heridas es un artículo de un solo uso que se puede desechar posterior a su uso.
14. El aparato de apósito para heridas según cualquier reivindicación anterior, que además comprende una bomba remota conectada al apósito para heridas.
15. El aparato de apósito para heridas según la reivindicación 14, en donde la bomba remota está montada en un área de borde del apósito para heridas.
16. El aparato de apósito para heridas as según la reivindicación 14 o 15, en donde la bomba remota incluye una fuente de potencia integral y circuitería de control.
17. El aparato de apósito para heridas según cualquier reivindicación anterior, en donde la capa absorbente está en comunicación de fluidos con la capa de filtro y/o en donde la capa de transmisión inferior está en comunicación de
fluidos con la capa de filtro.
18. El aparato de apósito para heridas según cualquier reivindicación anterior, que además comprende una tercera capa de transmisión permeable a gases entre la capa de cubierta y la capa de filtro.
19. El aparato de apósito para heridas según la reivindicación 1, en donde el aparato está configurado para aplicar presión negativa tópica en un sitio de herida y realizar las etapas de:
bombear el exudado de la herida y aire desde el sitio de la herida, estando sellada un área periférica alrededor de la herida con el apósito de herida; recoger el exudado de la herida, bombeado desde el sitio de la herida, en la capa absorbente del apósito para heridas; y expulsar gas a través del al menos un orificio en la capa de cubierta y la capa de filtro.
20. El aparato de apósito para heridas según la reivindicación 19, en donde el aparato está configurado para: conectar la capa de transmisión inferior a la capa de transmisión adicional en una o más localizaciones más allá de un borde de la capa absorbente.
21. El aparato de apósito para heridas según cualquier reivindicación anterior, en donde el aparato está configurado para proporcionar presión negativa en el intervalo de entre -50 mmHg y -200 mmHg
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