WO2014093840A1 - Dispositif pour protéger le cerveau chez les patients ayant subi une craniectomie - Google Patents

Dispositif pour protéger le cerveau chez les patients ayant subi une craniectomie Download PDF

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Publication number
WO2014093840A1
WO2014093840A1 PCT/US2013/075049 US2013075049W WO2014093840A1 WO 2014093840 A1 WO2014093840 A1 WO 2014093840A1 US 2013075049 W US2013075049 W US 2013075049W WO 2014093840 A1 WO2014093840 A1 WO 2014093840A1
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WO
WIPO (PCT)
Prior art keywords
layer
skull
brain
applying
patient
Prior art date
Application number
PCT/US2013/075049
Other languages
English (en)
Inventor
Jawad A. Shah
Original Assignee
IINN, Inc.
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 IINN, Inc. filed Critical IINN, Inc.
Publication of WO2014093840A1 publication Critical patent/WO2014093840A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • 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
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/58—Materials at least partially resorbable by the body
    • 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
    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
    • A61L31/04—Macromolecular materials
    • A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/02—Materials or treatment for tissue regeneration for reconstruction of bones; weight-bearing implants

Definitions

  • the present invention relates to methods of improving recovery from decompressive craniectomy.
  • DC Decompressive craniectomy
  • a monocryl suture has been developed to significantly reduce wound complications following hemicraniectomy that improves upon other closure techniques, but this method increases operative time and cost. The monocryl suture also does not allow for brain expansion that results in contralateral subdural and epidural hematomas.
  • U.S. Patent Application Publication No. 2008/0200954 to Tucci discloses a fastening system and method that includes a deformable connecting member configured for being connected at one end to a skull flap of a patient who has undergone a craniectomy procedure, and at the other end to the skull of the patient. In this manner, the skull flap is attached to the skull in a manner allowing limited movement of the skull flap. This allows for relief of intra-cranial pressures for patients having undergone a craniectomy procedure.
  • the connecting members are made of a material, which is biocompatible with the patient.
  • U.S. Patent Application Publication No. 2009/0036918 to Burgess discloses an apparatus for the containment of a surgical site, such as the area of a craniectomy procedure, and includes an enclosure, with at least one port, securely coupled to the surgical site and a source of pressurized fluid in fluid communication with the enclosure via the at least one port providing pressurized fluid to the surgical site.
  • the pressurized fluid establishes a hemostatic equilibrium within the enclosure by reducing blood egress through injuries in blood vessels at the surgical site thereby preventing bleeding at the surgical site.
  • the enclosure can be constructed from aluminum, titanium or a polymer such as, but not limited to, polyethylene terephthalate, polyacrylate, polyurethane, or polycarbonate.
  • At least a portion of the enclosure can be constructed from a transparent material thereby allowing a surgeon to see inside of the enclosure, or the enclosure can include a window formed therein to allow a surgeon to see inside the enclosure.
  • a method for the containment of a surgical site includes securely coupling an enclosure to a surgical site; fluidly coupling a source of pressurized fluid to the enclosure; and continuously providing pressurized fluid to the enclosure from the source of pressurized fluid and draining fluid from the enclosure. The pressurized fluid establishes a hemostatic equilibrium within the enclosure.
  • U.S. Patent Application Publication No. 2007/0293865 to Ko discloses a method of performing a decompressive craniectomy includes removing a bone flap from a cranium, attaching one end of a movable plate to one end of the bone flap, and attaching another end of the movable plate to the cranium.
  • the movable plate is configured to allow the bone flap to move to accommodate swelling of intracranial contents.
  • the movable plate can be made of titanium, titanium alloy, stainless steel, plastics, organic bioabsorbable substrate, or ceramics, or any combination of two or more thereof.
  • U.S. Patent No. 7,510,725 to Damien, et al. discloses dura substitutes to be used as prostheses for dural defects in the field of neurosurgery and processes for producing the same.
  • Damien, et al. provides artificial dura mater materials comprising sheets of microbial-derived polysaccharide processed to have the necessary strength characteristics, conformability and physical properties.
  • Damien, et al. does not disclose an additional waterproof and breathable layer to more fully protect a dural defect.
  • Miyake, et al. (Neurol Med Chir (Tokyo) 46, 104-106, 2006) describes a technique for decompressive craniectomy with duraplasty when brain swelling is present at closure.
  • An ePTFE membrane is placed under the dura, covering the brain surface, without the use of sutures. The dura is then loosely sutured.
  • One drawback to this method is that using ePTFE alone can result in adhesion to the brain or other tissue, and removal prior to craniotomy is complex and risky.
  • the present invention provides for a device including a first layer of a dural substitute and a second layer of a sheet of waterproof and breathable material.
  • the present invention provides for a method of covering a removed skull portion in a craniectomy by applying the first layer of the dural substitute over the exposed brain after the skull cap has been removed from a patient, fixing the second layer of the sheet of waterproof and breathable material over a portion of the skull that has been removed, preventing foreign substances from entering the skull, and allowing brain expansion.
  • the present invention also provides for a method of covering a surgical area in a patient after surgery, by applying a first layer of a dural substitute over an exposed area after surgery, fixing a second layer of a sheet of waterproof and breathable material over the first layer, and allowing for breathability in the surgical area, expansion of the surgical area, and protecting from fluid leakage.
  • the present invention provides for a method of covering a surgical area in a patient after surgery, by applying a first material layer that conforms to tissue and protects against fluid leakage, and applying a second material layer over the first layer that is waterproof, breathable, allows for expansion of the surgical area, and protects from fluid leakage.
  • FIGURE 1 is a cross-sectional view of the device applied to a patient's brain and skull.
  • FIGURE 2 is a top view of the device applied to a patient's brain and skull.
  • the present invention is generally directed to methods and devices to perform craniectomies and other surgeries.
  • Device 10, shown generally in FIGURES 1 and 2 preferably includes a first layer 12 of a dural substitute and a second layer 14 of a waterproof and breathable material.
  • the first layer 12 can be DURAGEN® (Integra) or any other suitable dura graft matrix, synthetic or biological, that conforms to brain tissue 18 (or other tissue), protects against cerebrospinal fluid leakage, and completely resorbs in the body over time.
  • DURAGEN® Integra
  • Other examples include, but are not limited to, LYOPLANT® (Aesculap), ETHISORB® Dura Patch (Codman), microbial-derived cellulose, or collagen-based dural substitutes.
  • the first layer 12 can be applied in sheets, sprayed, painted, or injected over the tissue 18 with any suitable applicator, in the form of a membrane, fabric, felt, sponge, non-woven matrix, or produced by 3D printing.
  • the first layer 12 can be packaged separately from the second layer 14 or the first layer 12 can be packaged with the second layer 14. Alternatively, the first layer 12 can be omitted at the surgeon's discretion depending on an individual patient's needs.
  • the second layer 14 of waterproof and breathable material allows for air or perspiration (such as water molecules) to escape from below the material and prevents water droplets from entering into the brain (hydrophobic) and is placed on the skull 16 (further described below).
  • the second layer 14 is in the form of a sheet that can be made or cut in various sizes depending on the area of open tissue.
  • the sheet can be made from expanded polytetrafluoroethylene.
  • the sheet is preferably a sheet of GORE-TEX® (W.L. Gore & Associates, Inc.), but can also be NEOSHELL® (Polartec), or OMNI-DRY® (Columbia Sportswear Company).
  • the sheet be non-adherent and preferably slippery and most preferably it is preferable for the material to be breathable yet capable of preventing penetration of bacteria and other pathogens and the like therethrough.
  • the sheet can include silicone and/or polyurethane, and preferably a silicone and/or polyurethane that does not degrade in the body.
  • the sheet can also be made from any other suitable surgical material that is sterile, maintains a watertight seal, and is approved for surgical use on human patients.
  • the second layer 14 can be sprayed, painted, or injected over the first layer 12 with any suitable applicator, in the form of a membrane, fabric, or produced by 3D printing. The second layer 14 can be in direct contact with the first layer 12.
  • the device 10 is used in the following manner after a craniectomy of a patient in order to cover a removed skull portion.
  • the first layer of the dural substitute is applied over the exposed brain after the skull cap has been removed from a patient.
  • the first layer conforms to brain tissue and protects against cerebrospinal fluid leakage.
  • the second layer of the sheet of waterproof and breathable material is fixed over a portion of a skull that has been removed from a patient, and prevents unwanted foreign substances from entering the skull and allows for brain expansion. The first layer then resorbs into the body.
  • the first layer and the second layer work synergistically in that the first layer protects against adhesion of brain or other tissue to the second layer, and the first layer conveniently becomes resorbed over a period of several weeks. This can yield significantly reduced risk after cranioplasty.
  • the skull portion can be inserted subcutaneously in the patient's abdomen. This allows the skull portion to remain sterile until it is replaced.
  • the second layer is placed atop bone outlying the incision in the skull, guideholes are drilled in the skull, and fixed in place with surgical screws or other securing mechanisms 20. Titanium grommets (not shown) can also be applied to shield the body from the screws or securing mechanisms 20.
  • the second layer and/or dural substitute are removed before cranioplasty takes place to reattach the skull portion.
  • the device can also be used in any other surgical procedure in order to cover a desired surgical area where breathability is desired as well as the possibility for expansion of the area, and protection from fluid leakage.
  • the device can be used in spinal surgery (such as discectomy, foramenotomy, laminectomy, spinal fusion, spinal disc replacement, or any anterior spinal procedure) or in any other suitable surgical procedure.
  • the present invention also provides for a method of covering a surgical area in a patient after surgery, by applying a first layer of a dural substitute over an exposed area after surgery, fixing a second layer of a sheet of waterproof and breathable material over the first layer, and allowing for breathability in the surgical area, expansion of the surgical area, and protecting from fluid leakage.
  • the present invention also provides generally for a method of covering a surgical area in a patient after surgery, by applying a first material layer that conforms to tissue and protects against fluid leakage, and applying a second material layer over the first layer that is waterproof, breathable, allows for expansion of the surgical area, and protects from fluid leakage. It should be understood that any materials that are able to perform the above functions can be used in this method.
  • Using the device in a surgical procedure can be atraumatic and cause no bleeding.
  • the device can provide quicker access or reaccess to a surgical site.
  • the device can be used to cover an injury site to allow for the transport of a patient.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

La présente invention concerne un dispositif comprenant une première couche d'un substitut dural et une deuxième couche d'une feuille de matériau imperméable à l'eau et perméable à l'air. La présente invention concerne un procédé pour recouvrir une partie de crâne enlevée dans une craniectomie en appliquant la première couche du substitut dural sur le cerveau exposé après que la calotte crânienne ait été enlevée chez un patient, la fixation de la deuxième couche de la feuille de matériau imperméable à l'eau et perméable à l'air sur une partie du crâne qui a été enlevée, ce qui empêche les corps étrangers de pénétrer dans le crâne, et permet l'expansion du cerveau. La présente invention concerne en outre un procédé pour recouvrir une zone chirurgicale chez un patient après une intervention chirurgicale, par application d'une première couche d'un substitut dural sur une zone exposée après chirurgie, la fixation d'une deuxième couche d'une feuille de matériau imperméable à l'eau et perméable à l'air au-dessus de la première couche, et l'étape consistant à permettre le passage d'air à travers la zone chirurgicale, l'expansion de la zone chirurgicale, et la protection contre les fuites de fluide.
PCT/US2013/075049 2012-12-13 2013-12-13 Dispositif pour protéger le cerveau chez les patients ayant subi une craniectomie WO2014093840A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261736617P 2012-12-13 2012-12-13
US61/736,617 2012-12-13

Publications (1)

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WO2014093840A1 true WO2014093840A1 (fr) 2014-06-19

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI568421B (zh) * 2015-01-23 2017-02-01 Skull surgery device
TWI577348B (zh) * 2015-01-23 2017-04-11 Skull surgery positioning system
RU2646567C1 (ru) * 2017-06-13 2018-03-05 Федеральное государственное бюджетное образовательное учреждение высшего образования "Воронежский государственный медицинский университет им. Н.Н. Бурденко" Министерства здравоохранения Российской Федерации Способ герметизации швов твердой мозговой оболочки
CN113171489A (zh) * 2020-11-09 2021-07-27 北京大学 一种透明的新型脑骨替代装置及其制备方法

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5357972A (en) * 1993-05-17 1994-10-25 Medical Graphics Corporation Disposable pneumotachograph flowmeter
US5997895A (en) * 1997-09-16 1999-12-07 Integra Lifesciences Corporation Dural/meningeal repair product using collagen matrix
US6436099B1 (en) * 1999-04-23 2002-08-20 Sdgi Holdings, Inc. Adjustable spinal tether
US20050283256A1 (en) * 2004-02-09 2005-12-22 Codman & Shurtleff, Inc. Collagen device and method of preparing the same
US20070293865A1 (en) * 2006-06-09 2007-12-20 Gyrus Productions Method of performing a decompressive craniectomy
US20090054995A1 (en) * 2007-07-24 2009-02-26 Aesculap Ag, A Corporation Of Germany Planar implant
US20120165879A1 (en) * 2009-09-27 2012-06-28 Rohit Khanna Telescopic cranial bone screw
US20120184999A1 (en) * 2010-12-13 2012-07-19 Neurovention, LLC Decompressive Craniotomy Device and Methodology
WO2012116401A1 (fr) * 2011-02-28 2012-09-07 Anatomics Pty Ltd Implant chirurgical et procédé associé

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5357972A (en) * 1993-05-17 1994-10-25 Medical Graphics Corporation Disposable pneumotachograph flowmeter
US5997895A (en) * 1997-09-16 1999-12-07 Integra Lifesciences Corporation Dural/meningeal repair product using collagen matrix
US6436099B1 (en) * 1999-04-23 2002-08-20 Sdgi Holdings, Inc. Adjustable spinal tether
US20050283256A1 (en) * 2004-02-09 2005-12-22 Codman & Shurtleff, Inc. Collagen device and method of preparing the same
US20070293865A1 (en) * 2006-06-09 2007-12-20 Gyrus Productions Method of performing a decompressive craniectomy
US20090054995A1 (en) * 2007-07-24 2009-02-26 Aesculap Ag, A Corporation Of Germany Planar implant
US20120165879A1 (en) * 2009-09-27 2012-06-28 Rohit Khanna Telescopic cranial bone screw
US20120184999A1 (en) * 2010-12-13 2012-07-19 Neurovention, LLC Decompressive Craniotomy Device and Methodology
WO2012116401A1 (fr) * 2011-02-28 2012-09-07 Anatomics Pty Ltd Implant chirurgical et procédé associé

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
WINSTON, KR ET AL.: "Bandages, dressings, and cranial neurosurgery", JOURNAL OF NEUROSURGERY: PEDIATRICS, vol. 106, no. 6, June 2007 (2007-06-01), pages 450 - 454 *

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI568421B (zh) * 2015-01-23 2017-02-01 Skull surgery device
TWI577348B (zh) * 2015-01-23 2017-04-11 Skull surgery positioning system
RU2646567C1 (ru) * 2017-06-13 2018-03-05 Федеральное государственное бюджетное образовательное учреждение высшего образования "Воронежский государственный медицинский университет им. Н.Н. Бурденко" Министерства здравоохранения Российской Федерации Способ герметизации швов твердой мозговой оболочки
CN113171489A (zh) * 2020-11-09 2021-07-27 北京大学 一种透明的新型脑骨替代装置及其制备方法

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