Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
  • A61B90/14—Fixators for body parts, e.g. skull clamps; Constructional details of fixators, e.g. pins
• • G—PHYSICS
  • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
  • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
  • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
  • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
• • G—PHYSICS
  • G09—EDUCATION; CRYPTOGRAPHY; DISPLAY; ADVERTISING; SEALS
  • G09B—EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS
  • G09B23/00—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes
  • G09B23/28—Models for scientific, medical, or mathematical purposes, e.g. full-sized devices for demonstration purposes for medicine
  • G09B23/30—Anatomical models
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
  • A61B2090/364—Correlation of different images or relation of image positions in respect to the body
  • A61B2090/365—Correlation of different images or relation of image positions in respect to the body augmented reality, i.e. correlating a live optical image with another image
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/50—Supports for surgical instruments, e.g. articulated arms
  • A61B90/57—Accessory clamps

Definitions

• FIG. 2 depicts a rear perspective view of the skull clamp of FIG. 1.
• FIG. 3 depicts a front perspective view of another exemplary skull clamp for use in simulating a patient stabilization.
• FIG. 4 depicts a rear perspective view of the skull clamp of FIG. 3.
• FIG. 5 depicts a front view of another exemplary skull clamp for use in simulating a patient stabilization.
• FIG. 10 depicts a schematic view of an exemplary physical skull clamp and an exemplary virtual skull clamp and virtual patient’s head shown on an exemplary display.
• FIGS. 1-4 illustrate an exemplary head stabilization simulation system 10 that includes a head fixation or stabilization device in the form of a skull clamp 100.
• Skull clamp 100 includes a frame 102 made up of a first arm 104 and a second arm 106. Each arm 104, 106 defines a respective upright portion 108 110 and a lateral or base portion 112, 114.
• First and second arms 104, 106 are adjustable in their relative position to change a space between them to accommodate patient heads of various size.
• skull clamp 100 includes a ratchet system that allows first arm 104 and second arm 106 to be moved closer together.
• adapter assembly 120 may be detachable and re-attachable with skull clamp 100 at either first arm 104 or second arm 106. Irrespective of the connection means with skull clamp 100, adapter assembly 120 is connectable with skull clamp 100 in a consistent and repeatable way such that the position (i.e., coordinates in three-dimensional system), and orientation (i.e., tilt or angulation about axes in three-dimensional system) of adapter assembly 120 relative to skull clamp 100 is known or defined.
• First arm 204 includes a stabilization assembly 216
• second arm 206 includes a stabilization assembly 218.
• Each stabilization assembly 216, 218 is configured to receive at least one stabilization feature (not shown), which may be a skull pin in some examples, or a pad in some other examples.
• skull clamp 200 may be configured to use a combination of stabilization feature types, i.e., some pins and some pads in the same use configuration.
• skull clamp 200 is selectively connectable with other structures, such as one or more of a swivel adapter, a base unit, an operating table, etc. when used to stabilize the head of a patient.
• each is configured to selectively receive a computing device, such as computing devices 400, 401 discussed later.
• Adapter assembly
• skull clamp 200 having dual adapter assemblies 220, 221 and two computing devices 400, 401, in some versions the position and orientation of computing device 401, e.g., is known based on communication between computing devices 400, 401.
• one computing device can be the primary computing device for the initial position and orientation and the other computing device can be the secondary computing device where its position and orientation is determined relative to the primary computing device.
• skull clamp 200 includes the ability for a width adjustment by changing the position of first and second arms 204, 206 relative to each other.
• a benefit of skull clamp 200 with dual adapter assemblies 220, 221 and computing devices 400, 401 is that the width setting or configuration of skull clamp 200 can be determined.
• Computing device 400 can be associated with connected devices 426 that may be external to computing device 400 and either wired or wirelessly connected with computing device 400.
• an exemplary connected device 426 comprises an external display 428.
• external display 428 is a monitor located remote from computing device 400.
• connected devices 426 includes glasses or goggles equipped with a display such that a user can wear the glasses or goggles and view content received from computing device 400 and displayed on the glasses or goggles.
• connected devices 426 includes a separate computing device that may be detected and/or paired with computing device 400.
• Step 606 involves selecting stabilization equipment parameters. These may include, among others, things like the skull clamp model being used, the adapter assembly configuration (i.e., single adapter assembly or dual adapter assembly), the stabilization features (i.e., pin configuration and/or pad configuration), and any other equipment that would be used in the actual stabilization (i.e., swivel adapter, base unit, table adapter, operating table, etc.).
• Step 608 involves selecting key process indicators (KPI) reporting. Based on the simulated stabilization conducted, this would include metrics like a surgeon ergonomic rating, a patient positioning rating, an equipment selection rating, a time, etc.
• Step 610 involves selecting test or evaluation parameters.
• KPI key process indicators
• KPI for the patient positioning rating information about the ultimate position and orientation of the patient is used to assess a risk of injury or trauma to the patient. The time a patient is maintained in a given position may also be a factor. Where a simulated stabilization results in a low risk of injury to the patient, a more desirable KPI rating is assigned. Conversely, where there is a greater risk of injury or trauma to the patient, a less desirable KPI rating is assigned.
• the stabilization feature used comprises one or more skull pins
• a pinning rating can be either a standalone KPI or incorporated as a factor within the KPI for the patient positioning rating.
• factors to consider can include, among others, the pinning geometry (i.e., is a triangular pinning geometry present), the pinning location (i.e., are two of three pins located below the equator of the skull; does the pinning location avoid the forehead area that would leave cosmetic scarring as opposed to being concealed within the hairline), and the pinning depth relative to the bone structure (i.e., would the insertion depth and required force be suitable for the patient’s given bone structure). Still other factors or considerations for pinning location include if the pins are located in the safe zone.
• the user visualizes a virtual reality environment 700 on a display that in one version is the display 410 of computing device 400.
• this display can be a display that is external to computing device 400, i.e., a glasses or goggles display, a remote monitor, etc.
• the user observes a virtual skull clamp 300 that represents the physical skull clamp 100, 200. Additionally, the user observes a virtual representation of the patient’s head 310 in virtual reality environment 700.
• the user manipulates the physical skull clamp 100, 200 to change its position and/or orientation.
• the user would grasp skull clamp 100 or skull clamp 200 depending on the setup, and move the skull clamp to change its position and/or to change its orientation.
• a change in position refers to a change in the spatial three-dimensional coordinates
• a change in orientation refers to a change in the tilt or angulation about axes in the three-dimensional system, i.e., X, Y, and Z axes defined e.g., by the skull clamp.
• the user visualizes virtual reality environment 700 on the display to observe movements of virtual skull clamp 300 relative to the virtual head of the patient 302 based on or mimicking the movements of physical skull clamp 100 or skull clamp 200 as the case may be.
• application 500 is in an education or training mode.
• the user manipulates the position and/or orientation of skull clamp 100 or skull clamp 200, as the case may be depending on which skull clamp is being used. This manipulation is done according to instructions from application 500.
• application 500 instructs or guides the user as to how to manipulate the position and/or orientation of skull clamp 100, 200 to achieve an acceptable virtual patient stabilization or an optimal virtual patient stabilization in virtual reality environment 700.
• step 624 application 500 is in a test or evaluation mode.
• the user In this mode, the user’s performance of conducting a virtual stabilization is assessed.
• application 500 does not instruct or guide the user in a step-by-step fashion as described above with respect to step 622. Instead, application 500 monitors the movements the user makes with skull clamp 100, 200 to achieve the virtual stabilization and thereafter can provide feedback as an output in terms of KPI reporting, etc.
• the order of the steps depicted in FIG. 9 is not fixed such that the steps may occur in any order and are not required to be carried out precisely sequentially as shown.
• virtual skull clamp 300 is shown without adapter assemblies shown to provide a more realistic visual experience since the actual skull clamps used in the actual procedures may not include the adapter assemblies.
• various other ways to correlate the position and orientation of a physical skull clamp to a virtual skull clamp and depict the same using application 500 and computing device 400 or a similar application and/or computing device will be apparent to those of ordinary skill in the art.

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Medical Informatics (AREA)
• General Health & Medical Sciences (AREA)
• Physics & Mathematics (AREA)
• General Physics & Mathematics (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Molecular Biology (AREA)
• Heart & Thoracic Surgery (AREA)
• Biomedical Technology (AREA)
• Veterinary Medicine (AREA)
• Pathology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Computational Mathematics (AREA)
• Mathematical Optimization (AREA)
• Educational Technology (AREA)
• Educational Administration (AREA)
• Business, Economics & Management (AREA)
• Pure & Applied Mathematics (AREA)
• Mathematical Physics (AREA)
• Theoretical Computer Science (AREA)
• Mathematical Analysis (AREA)
• Algebra (AREA)
• Medicinal Chemistry (AREA)
• Chemical & Material Sciences (AREA)
• Neurosurgery (AREA)
• Surgical Instruments (AREA)
• Instructional Devices (AREA)

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• 2023
  • 2023-05-15 WO PCT/IB2023/000252 patent/WO2023223090A1/en not_active Ceased
  • 2023-05-15 US US18/317,491 patent/US20230363850A1/en active Pending
  • 2023-05-15 EP EP23735366.9A patent/EP4526872A1/en active Pending
  • 2023-05-15 JP JP2024568008A patent/JP2025518510A/ja active Pending
  • 2023-05-15 CN CN202380040985.8A patent/CN119487562A/zh active Pending

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