ES2579490T3 - Sistemas de implante para tratar apnea obstructiva del sueño - Google Patents

Sistemas de implante para tratar apnea obstructiva del sueño Download PDF

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Publication number
ES2579490T3
ES2579490T3 ES09764133.6T ES09764133T ES2579490T3 ES 2579490 T3 ES2579490 T3 ES 2579490T3 ES 09764133 T ES09764133 T ES 09764133T ES 2579490 T3 ES2579490 T3 ES 2579490T3
Authority
ES
Spain
Prior art keywords
implant
tongue
sleep apnea
obstructive sleep
loop
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
Application number
ES09764133.6T
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English (en)
Inventor
Kevin S. Weadock
Robert A. Rousseau
John R. Jacobs
David Lindh, Sr.
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.)
Ethicon Inc
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Ethicon Inc
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Filing date
Publication date
Priority claimed from US12/325,350 external-priority patent/US8783258B2/en
Application filed by Ethicon Inc filed Critical Ethicon Inc
Application granted granted Critical
Publication of ES2579490T3 publication Critical patent/ES2579490T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
    • 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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • 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
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/56—Devices for preventing snoring
    • A61F5/566—Intra-oral devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/02—Inorganic materials
    • A61L27/04—Metals or alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00535—Surgical instruments, devices or methods pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0404—Buttons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • A61B2017/06176—Sutures with protrusions, e.g. barbs

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Nursing (AREA)
  • Pulmonology (AREA)
  • Otolaryngology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Prostheses (AREA)
  • Orthopedics, Nursing, And Contraception (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Un sistema (1100) para tratar apnea obstructiva del sueño que comprende: un primer implante (1200, 1300,b,c,d, 1405) adaptado para su implantación en una región submandibular y un elemento de tipo lazo (1105, 1401) que tiene un primer (1110) y un segundo (1112) extremo caracterizado porque el primer implante (1200, 1300b,c,d, 1405) tiene al menos una abertura (1202, 1304, 1404) a través del mismo y porque el elemento de tipo lazo (1105, 1401) tiene una sección transversal no circular y sustancialmente uniforme a lo largo de la longitud del mismo, donde el elemento de tipo lazo (1105, 1401) está adaptado para su implantación en una lengua (L) con el primer (1110) y segundo (1112) extremo se extiende a través de al menos una abertura (1202, 1404) en el primer implante (1200, 1300b,c,d, 1405) para acoplar dicho elemento de tipo lazo (1105, 1401) con dicho primer implante 1200, 1300b,c,d, 1405).

Description

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La primera parte de implante 22 o elemento de fijación mostrado y descrito anteriormente puede implantarse en el tejido submandibular y más preferentemente entre la musculatura de genihioideo GH y la musculatura de milohioideo MH. En una realización, la primera parte de implante 22 están en una capa poroso que permite el crecimiento interno del tejido (por ejemplo, tejido cicatricial) en las capas, y está preferentemente implantado entre la musculatura de genihioideo GH y la musculatura de milohioideo MH como parte de una primera fase de procedimiento quirúrgico. Los músculos genihioideo y milohioideo están deseablemente expuestos al hacer una pequeña incisión en el tejido plegado bajo la mandíbula MD. Después de implantar la primera parte de implante 22, la primera parte de implante 22 se deja en su lugar para que el tejido cicatricial puede formarse en y/o alrededor de la primera parte de implante. El tejido cicatricial que se forma en y/o alrededor de la primera parte de implante. El tejido cicatricial que se formar en y/o alrededor de la primera parte de implante forma preferentemente un plano cicatricial o placa cicatricial que se extiende entre la musculatura de genihioideo GH y la musculatura de milohioideo MH. El plano cicatricial o placa cicatricial forma deseablemente un ancla suave para una segunda parte de implante colocad en una lengua, como se describirá con más detalle más abajo. La primera parte de implante puede reabsorberse cuando se forma el tejido cicatricial.
Ahora en referencia a las FIGS. 7A y 7B, después de haber implantado la primera parte de implante 22 entre la musculatura de genihioideo GH y la musculatura de milohioideo MH, y después de haber dejado que se forme el tejido cicatricial (por ejemplo, un plano cicatricial) alrededor de la primera parte de implante 22, una segunda parte de implante 24, como se ha mostrado y descrito anteriormente en las FIGS. 4B y 5A-C, pueden conectarse con la primera parte de implante 22 y/o el tejido cicatricial que se ha formado alrededor de la primera parte de implante.
La segunda parte de implante o implante de lengua puede implantarse haciendo avanzar el primer y segundo brazo 32, 32 de la segunda parte de implante 24 en direcciones laterales a través de la parte trasera de la lengua L hasta que la sección de contrafuerte 30 de la segunda parte de implante 24 se centra en la lengua L. El avance del primer y segundo brazo se facilitar preferentemente uniendo elementos penetrantes en tejido tales como agujas a los extremos libres de ambos brazos. En una realización, un trocar de diámetro pequeño avanza deseablemente a través de la musculatura y a la base de la boca cercana a la base de la lengua. Puede introducirse un lazo a través del lumen de cada trocar para agarrar los extremos distales 24, 26 del respectivo primer y segundo brazo 30, 32. Se tira del primer y segundo brazo 30, 32 a través del trocar y el trocar se retira. Se tira de los extremos libres 26, 28 del primer y segundo brazo 32, 34 deseablemente hasta que la parte trasera de la lengua L avanza justo lo suficiente para no formar un sello contra la pared trasera de la faringe. El primer y segundo brazo 32, 34 pueden unirse a la primera parte de implante 22 y/o el tejido cicatricial para fijar la lengua en la nueva posición. En realizaciones donde la primera parte de implante es reabsorbible y donde el tejido cicatricial se forma sin usar un implante, el primer y segundo brazo pueden estar unidos al tejido cicatricial formado en la región mandibular. Al asegurar la primera parte de implante 22 en el tejido blando tal como el plano entre la musculatura de genihioideo GH y la musculatura de milohioideo MH, se evita el efecto “cortador de queso” encontrado en los implantes de lengua que tienen topes duros (por ejemplo, un ancla ósea). El primer y segundo brazo 32, 34 de la segunda parte de implante 24 pueden estar unidos al primer implante y/o tejido cicatricial usando suturas, pegamento, palancas, soldadura ultrasónica, interferencia con elementos con púas, o atadura directa de la segunda parte de implante alargado 24 con la primera parte de implante 22 o el tejido cicatricial.
En una realización, la segunda parte de implante está fabricada como un armazón trenzado estrecho hueco a través del cual los extremos libres del primer y segundo brazo pasan. Una vez que la lengua se fija en la posición adecuada, el extremo grande del tubo flexible pasa sobre los extremos flexibles del primer y segundo brazo. El extremo con diámetro pequeño del tubo se empuja hacia arriba en la dirección de la lengua en unión con el elemento con púas. Cuando el tubo colapsa y el extremo con diámetro pequeño del tubo se aprieta contra el extremo con diámetro grande, la masa colapsada del tubo sirve cono un elemento que soporta la caga contra el tejido blando circundante. Aunque esta realización particular no está limitada por ninguna teoría particular de operación, se cree que la estructura anteriormente descrita proporciona un número infinito de localizaciones o puntos de fijación para cada extremo distal del primer y segundo brazo de la primera parte del implante.
Un cirujano puede ajustar la longitud del respectivo primer y segundo brazo 32, 34 para mover la lengua T en una dirección anterior y/o inferior para minimizar la posibilidad de episodios de AOS. El primer y segundo brazo 32, 34 pueden incluir púas que permiten que el primer y segundo brazo avancen a través de los intersticios o poros de la primera parte de implante 22 y/o el tejido cicatricial en la región mandibular. Las púas permiten preferentemente que los brazos se muevan más fácilmente en la dirección designada A1, mientras proporcionan más resistencia al movimiento cuando se tira de los brazos en la dirección designada A2.
En referencia a las FIGS. 8A y 8B, en una realización, la segunda parte de implante 24 o implante de lengua está preferentemente situado en la lengua L para que la sección de contrafuerte 30 se sitúe en el centro del cuerpo de la lengua y se extienda lateralmente hacia los lados de la cavidad oral. La sección de contrafuerte 30 se extiende a lo largo de un eje que atraviesa o es sustancialmente perpendicular a un eje anterior-posterior (designado A-P) de la lengua L, y preferentemente tiene un área de superficie más grande que otras secciones de la segunda parte de implante 24 para fijar la segunda parte de implante en su lugar para evitar el efecto “cortador de queso” presente cuando se usan implantes con posiciones de fijación inmovibles (por ejemplo, anclas de hueso), o implantes que tienen un filamento con un diámetro relativamente pequeño implantado en la lengua. El primer y
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Claims (1)

  1. imagen1
ES09764133.6T 2008-12-01 2009-11-20 Sistemas de implante para tratar apnea obstructiva del sueño Active ES2579490T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US325350 1981-11-27
US12/325,350 US8783258B2 (en) 2008-12-01 2008-12-01 Implant systems and methods for treating obstructive sleep apnea
US12/578,271 US8800567B2 (en) 2008-12-01 2009-10-13 Implant systems and methods for treating obstructive sleep apnea
US578271 2009-10-13
PCT/US2009/065293 WO2010065341A1 (en) 2008-12-01 2009-11-20 Implant systems and methods for treating obstructive sleep apnea

Publications (1)

Publication Number Publication Date
ES2579490T3 true ES2579490T3 (es) 2016-08-11

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ID=41527649

Family Applications (1)

Application Number Title Priority Date Filing Date
ES09764133.6T Active ES2579490T3 (es) 2008-12-01 2009-11-20 Sistemas de implante para tratar apnea obstructiva del sueño

Country Status (12)

Country Link
US (2) US8800567B2 (es)
EP (1) EP2381904B1 (es)
JP (1) JP5502100B2 (es)
KR (1) KR101590338B1 (es)
CN (1) CN102231972B (es)
AU (1) AU2009322708B2 (es)
BR (1) BRPI0922768A2 (es)
CA (1) CA2745146C (es)
ES (1) ES2579490T3 (es)
NZ (1) NZ592742A (es)
RU (1) RU2519960C2 (es)
WO (1) WO2010065341A1 (es)

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US8915252B2 (en) 2014-12-23
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US20130186412A1 (en) 2013-07-25
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NZ592742A (en) 2013-08-30

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