WO2017190126A1 - Procédé de mise en correspondance rapide de plaques et gabarit de cranioplastie - Google Patents

Procédé de mise en correspondance rapide de plaques et gabarit de cranioplastie Download PDF

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Publication number
WO2017190126A1
WO2017190126A1 PCT/US2017/030368 US2017030368W WO2017190126A1 WO 2017190126 A1 WO2017190126 A1 WO 2017190126A1 US 2017030368 W US2017030368 W US 2017030368W WO 2017190126 A1 WO2017190126 A1 WO 2017190126A1
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WO
WIPO (PCT)
Prior art keywords
plates
kit
cranioplasty
patient
templates
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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.)
Ceased
Application number
PCT/US2017/030368
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English (en)
Inventor
Matthew A. Howard
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.)
University of Iowa Research Foundation UIRF
Original Assignee
University of Iowa Research Foundation UIRF
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 University of Iowa Research Foundation UIRF filed Critical University of Iowa Research Foundation UIRF
Publication of WO2017190126A1 publication Critical patent/WO2017190126A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • 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 or setting implements
    • 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
    • A61B17/8061—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20—Holders specially adapted for surgical or diagnostic appliances or instruments
    • A61B50/22—Racks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B50/00—Containers, covers, furniture or holders specially adapted for surgical or diagnostic appliances or instruments, e.g. sterile covers
    • A61B50/20—Holders specially adapted for surgical or diagnostic appliances or instruments
    • A61B50/24—Stands
    • 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
    • A61F2/28—Bones
    • A61F2/2875—Skull or cranium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • A61B2034/108—Computer aided selection or customisation of medical implants or cutting guides
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30604—Special structural features of bone or joint prostheses not otherwise provided for modular
    • A61F2002/30616—Sets comprising a plurality of prosthetic parts of different sizes or orientations
    • 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
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30667—Features concerning an interaction with the environment or a particular use of the prosthesis
    • A61F2002/3071—Identification means; Administration of patients
    • 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
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2002/4632—Special tools for implanting artificial joints using computer-controlled surgery, e.g. robotic surgery
    • A61F2002/4633—Special tools for implanting artificial joints using computer-controlled surgery, e.g. robotic surgery for selection of endoprosthetic joints or for pre-operative planning

Definitions

  • a craniectomy is a medical surgical procedure commonly performed to manage intractable brain swelling, often caused by trauma or stroke.
  • two surgeries are normally required.
  • a craniotomy is performed, wherein a section of the skull is removed and then the skin or scalp is closed over the skull opening.
  • the craniectomy allows for the brain tissue to expand through the opening to reduce intracranial pressure.
  • a second cranioplasty operation is required to replace the saved native bone material, or alternatively, to implant a prosthetic skull piece, such as a thin titanium skull plate. This second operation restores a solid covering over the skull opening or defect.
  • the removal of the skull section during the craniectomy procedure allows the brain tissue to expand without restriction by the skull. Without the skull protection, the brain is vulnerable under the skin until swelling reduces in the following weeks or months, and the cranioplasty surgery takes place to repair the skull defect.
  • the patient normally wears a helmet to protect the brain.
  • the cranioplasty surgery increases the high costs associated with caring for these injured patients.
  • the cranioplasty procedure also increases the risk of further injury to the patient, due to the requirement to manipulate scalp and brain tissue during the cranioplasty procedures. These risks include intracranial hemorrhage and seizures, infection, and wound breakdown.
  • the implanted cranioplasty plate For a cranioplasty procedure to be successful the implanted cranioplasty plate must have a size and shape that fits the patient's skull well.
  • a custom cranial plate can be manufactured to properly fit the patient's skull.
  • Such custom plates are produced using a CT scan of the patient, with the CT scan data being sent to a manufacturer.
  • An image processing algorithm is used to define the dimensions of the removed or missing bone flap for the patient.
  • a computer-aided manufacturing machine can create the custom cranial plate using the patient's imaged data. The plate is then shipped to the hospital prior to the scheduled craniectomy implantation surgery.
  • a primary objective of the present invention is the provision of a method for matching a cranioplasty plate selected from a kit of multiple plates to fit a patient's skull.
  • Another objective of the present invention is the provision of a method for matching a cranial plate template from a kit of different sized and shaped templates, to the patient's skull.
  • Another objective of the present invention is a provision of a method of quickly matching cranioplasty templates and plates to a patient's skull utilizing imaging data of the patient's skull.
  • a further objective of the present invention is the provision of a method to quickly and easily provide a properly fit cranioplasty plate for a patient.
  • Still another objective of the present invention is the provision of a kit of cranioplasty plates and templates for use in emergency combined craniectomy-cranioplasty procedures.
  • Another objective of the present invention is the provision of a process which allows for selection of an appropriate cranioplasty plate from a collection of plates done virtually over the internet by a technician remote from the operating room.
  • a further objective of the present invention is the provision of a collection of different sized and shaped cranioplasty plates held in spaced apart upright positions by a slotted base, with indicia on each plate to facilitate quick and easy selection of the appropriate plate for a patient based upon on imaging of the patient's skull.
  • Yet another objective of the present invention is the provision of a set of cranioplasty plates and a set of cranioplasty templates, both having varying sizes and shapes, and in which corresponding pairs of plates and templates having identical indicia for proper matching of a selected template and a selected plate.
  • a further objective of the present invention is the provision of a process for simplifying emergency or non-elective combined craniectomy-cranioplasty operations which quickly, easily and safely matches a cranioplasty plate to a patient's skull opening.
  • a method for matching a cranioplasty plate to the skull opening of a patient who has had a craniectomy, particularly in an emergency or a non-elective clinical setting involves the collection or creation of a kit having a plurality of different sized and shaped cranioplasty plates. Imaging data of the patient's skull is provided to a technician or other medical personnel. Then, one of the cranioplasty plates from the kit or collection is selected which most closely matches skull dimensions obtained from the patient's imaging data. The selection or matching step may be done from a location remote from the operating room, such as over the internet using email or other communication tools.
  • the kit includes a comprehensive range of plates which may be used for different patients having skulls of different sizes and shapes.
  • the kit may also include a plurality of bone flap templates, each having different sizes and shapes.
  • the cranioplasty plates and the cranial plate templates have indicia, such as numbering, to quickly match pairs of templates and cranioplasty plates, in accordance with the results of the imaging data analysis.
  • the plates and templates are stored in a sterilized environment, such as in a stand or base having slots to hold the plates and templates in spaced apart, upright orientations.
  • Figure 1 is a flow chart showing one embodiment of the cranioplasty template matching process of the present invention.
  • Figure 2 is sketch showing an example of a kit having different sized and shaped cranioplasty templates, according to the present invention.
  • Figure 3 is a sketch showing an exploded view of a kit, with a base and multiple plates and/or templates, in accordance with the present invention.
  • the present invention provides a range of cranioplasty plates and templates of various sizes and shapes in a kit stored on-site, in or near the operating room, so that an appropriately sized template and plate can be selected from the kit at the operating room supply facility and used with a craniectomy patient.
  • the kit will contain a first set of numbered cranioplasty plates 10 (Figure 3), and a second set of numbered templates 12 ( Figure 3) which do not have the functionality of the plates but which match the plates 10 in size and shape.
  • the templates 12 are used to confirm the proper plate size to implant, and to trace around so as to outline the dimensions of the bone flap that will be removed from the patient's skull.
  • each kit includes at least one base or stand 14 having a plurality of slots 16 which hold the plates 10 and templates 12 in spaced apart, substantially vertical or upright positions.
  • the slots 16 can be formed in the base 14, as shown in Figure 3, or can be formed by upstanding fingers or dividers 18, as shown in Figure 2.
  • all the templates 12 and plates 10 can be stored upright in one base or stand 14.
  • separate bases or stands 14 can be provided for the plates 10 and templates 12, and/or for the left and right hemisphere of the skull, to segregate the left and right plates, and the left and right templates.
  • a cover (not shown) may be provided on the base to enclose the plates and templates, and to maintain sterility of the plates and templates.
  • kits of cranioplasty plates 10 and templates 12 a study or survey can be conducted to determine the range of skull plate sizes and shapes that are appropriate for patients undergoing decompressive craniectomy operations. For example, 100 patients who have undergone such surgery can be sampled so as to ascertain a comprehensive range of "off the shelf plate sizes/shapes which would collectively provide an acceptable "fit" for all possible craniectomy patients.
  • the kit can include 12-15 different sizes with left and right hemisphere plates. Every hospital which performs such craniectomy surgical procedures will have the kit containing the full size/shape range of sterilized plates ready for implantation.
  • the plates 10 and templates 12 have indicia, such as numbers, as shown at the top of the templates in Figure 2 and the top of the plates in Figure 3, for ease of selection.
  • the indicia can be located anywhere on the templates and plates that allows for easy reading while the plates and templates are stored in the slots of the base.
  • the process for selecting the properly sized plate from the kit should be efficient and effective.
  • the plate/template selection can be made by the surgeon prior to implantation.
  • the selection process can utilize telemedicine and image processing technologies. Since all trauma surgery hospitals have electronic medical record (EMR) systems 20 which store digital imaging data 22, when a patient who will require a craniectomy has a CT scan 24, the imaging data 22 is placed in the EMR system 20 for access via the internet 26 to care providers 28 and cranial plate companies 30 located anywhere.
  • EMR electronic medical record
  • the surgeon reviews the patient's CT scan and other clinical relevant data, and decides whether to perform a decompressive craniectomy procedure. If such an emergency procedure is required, the operating room staff is notified and the procedure is scheduled.
  • a trained member of the staff sends an email (preferably with secured encryption) to create a patient medical record number (MRN), and indicate whether a left or right sided hemicraniectomy procedure is planned.
  • MRN patient medical record number
  • a trained representative downloads the patient's CT scan data, and then creates a surface rendering of the patient's skull.
  • a virtual bone flap template scaled to the patient's skull is overlaid on the image using a standard imaging algorithm.
  • the representative uses the same algorithm to determine or select the cranioplasty plate size from the kit of plates, which conforms best to the size and shape of the patient's skull.
  • This "best fit” information is then sent to the operating room staff, preferably by secure email, which then conveys the information to the surgeon who uses the information for selection of the template 12 and the cranioplasty plate 10, in an efficient and effective manner. This process eliminates the time-consuming trial and error empiric fitting process that would be required otherwise in attempting to select and match the proper template and plate to the patient's skull.
  • Figure 1 shows the process according to the present invention, for the templates contained in the kit. Once the kits are created, they can be maintained on site at the hospital. As templates 12 and plates 10 are removed from the kit, the kit should be replenished to maintain a full set of the ranges of different sized and shaped templates and plates.
  • the kit of cranioplasty plates 10 and templates 12 includes a container or case for enclosing and storing the plates and templates.
  • the plates and templates can be housed in separate containers.
  • the container or case should be maintained in a sterile condition.
  • the plates and templates can be sterilized after removal from the case and before use on the patient.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention porte sur un procédé permettant de mettre en correspondance une plaque et un gabarit de cranioplastie sur le crâne d'un patient conjointement avec une intervention chirurgicale de craniectomie d'urgence ou non élective. L'invention concerne également un kit contenant une pluralité de tailles et de formes de plaques de cranioplastie et de gabarits de plaques, de sorte que le praticien ou technicien médical peut sélectionner la plaque et le gabarit qui correspondent le mieux aux dimensions du crâne du patient sur la base de l'imagerie du crâne. Le kit et le procédé de sélection rendent inutile de fabriquer une plaque de cranioplastie personnalisée et permettent ainsi également de gagner du temps.
PCT/US2017/030368 2016-04-29 2017-05-01 Procédé de mise en correspondance rapide de plaques et gabarit de cranioplastie Ceased WO2017190126A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201662329659P 2016-04-29 2016-04-29
US62/329,659 2016-04-29

Publications (1)

Publication Number Publication Date
WO2017190126A1 true WO2017190126A1 (fr) 2017-11-02

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2017/030368 Ceased WO2017190126A1 (fr) 2016-04-29 2017-05-01 Procédé de mise en correspondance rapide de plaques et gabarit de cranioplastie

Country Status (1)

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WO (1) WO2017190126A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5690631A (en) * 1996-09-11 1997-11-25 Walter Lorenz Surgical, Inc. Multi-configurable plating system
US20120138495A1 (en) * 2009-11-09 2012-06-07 Bettenhausen Cary A Universal surgical fastener sterilization caddy
US20120203289A1 (en) * 2009-09-24 2012-08-09 Academisch Ziekenhuis Maastricht Cranial implant
US20150265448A1 (en) * 2012-11-09 2015-09-24 Ernst-Johannes HABERL System for reshaping skull

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5690631A (en) * 1996-09-11 1997-11-25 Walter Lorenz Surgical, Inc. Multi-configurable plating system
US20120203289A1 (en) * 2009-09-24 2012-08-09 Academisch Ziekenhuis Maastricht Cranial implant
US20120138495A1 (en) * 2009-11-09 2012-06-07 Bettenhausen Cary A Universal surgical fastener sterilization caddy
US20150265448A1 (en) * 2012-11-09 2015-09-24 Ernst-Johannes HABERL System for reshaping skull

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