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WO2024156054A1 - Ensemble instrument chirurgical articulé et ses utilisations - Google Patents

Ensemble instrument chirurgical articulé et ses utilisations Download PDF

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Publication number
WO2024156054A1
WO2024156054A1 PCT/CA2024/050074 CA2024050074W WO2024156054A1 WO 2024156054 A1 WO2024156054 A1 WO 2024156054A1 CA 2024050074 W CA2024050074 W CA 2024050074W WO 2024156054 A1 WO2024156054 A1 WO 2024156054A1
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WO
WIPO (PCT)
Prior art keywords
effector
shaft
instrument assembly
assembly
tool
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.)
Ceased
Application number
PCT/CA2024/050074
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English (en)
Inventor
Dale Podolsky
Jones LAW
James Drake
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Hospital for Sick Children HSC
Original Assignee
Hospital for Sick Children HSC
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Filing date
Publication date
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Publication of WO2024156054A1 publication Critical patent/WO2024156054A1/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
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1604—Chisels; Rongeurs; Punches; Stamps
    • A61B17/1606—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other
    • A61B17/1608—Chisels; Rongeurs; Punches; Stamps of forceps type, i.e. having two jaw elements moving relative to each other the two jaw elements being linked to two elongated shaft elements moving longitudinally relative to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1613—Component parts
    • A61B17/1633—Sleeves, i.e. non-rotating parts surrounding the bit shaft, e.g. the sleeve forming a single unit with the bit shaft
    • 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
    • A61B34/30—Surgical robots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/14—Surgical saws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1613—Component parts
    • A61B17/1631—Special drive shafts, e.g. flexible shafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3201—Scissors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00305—Constructional details of the flexible means
    • A61B2017/00314—Separate linked members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B2017/1602—Mills
    • 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
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A61B2034/2046—Tracking techniques
    • A61B2034/2055—Optical tracking systems
    • 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
    • A61B34/30—Surgical robots
    • A61B2034/301—Surgical robots for introducing or steering flexible instruments inserted into the body, e.g. catheters or endoscopes
    • 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
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • 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
    • A61B90/37—Surgical systems with images on a monitor during operation

Definitions

  • the present disclosure relates generally to surgical instruments, and in particular to surgical instruments having a guide assembly for use in craniofacial surgery.
  • Craniosynostosis is a congenital abnormality in which the cranial sutures of a baby’s skull prematurely fuse and affects 3-5 children per 10,000 live births.
  • the fused suture can restrict cranial growth, decrease cerebral blood flow, increase intracranial pressure, and cause craniofacial dysmorphism (see, Thompson DR, Zurakowski D, Haberkem CM, Stricker PA, Meier PM, Bannister C, et al. Endoscopic Versus Open Repair for Craniosynostosis in Infants Using Propensity Score Matching to Compare Outcomes: A Multicenter Study from the Pediatric Craniofacial Collaborative Group. Anesthesia and analgesia.
  • Cranial suture fusions result in characteristic abnormal head shapes.
  • Surgery is often recommended to correct the abnormal head shape as well as to prevent functional sequalae such as elevated intracranial pressure.
  • Surgery can be performed either open or minimally invasively using an endoscope.
  • the endoscopic approach has specific advantages due to its lower invasiveness resulting in less blood loss, shorter hospital stay, decreased size of the required incisions, and reduced operative time and cost (see, Thompson and Goyal A, Lu VM, Yolcu YU, Elminawy M, Daniels DJ. Endoscopic versus open approach in craniosynostosis repair: a systematic review and meta-analysis of perioperative outcomes. Child's nervous system.
  • the open approach utilizes a large bicoronal incision that allows for more extensive osteotomies and correction of the abnormal head shape.
  • the open approach may result in more blood loss, may present a higher risk of blood transfusion and may result in a longer hospital stay and operative time (see Yan, H., Abel, T. J., Alotaibi, N. M., Anderson, M., Niazi, T. N., Weil, A. G., Fallah, A., Phillips, J. H., Forrest, C. R., Kulkarni, A. V., Drake, J. M., & (2004), G. M. (2018).
  • the patient does not require a molding helmet as the bones can be reshaped and repositioned more extensively using the large open exposure.
  • surgeons utilize conventional surgical instruments to perform the endoscopic approach.
  • These conventional surgical instruments usually consist of three parts: an end-effector (typically comprising a scissor, a grasper, a bone punch, and/or other instruments), a straight extension rod, and a handle.
  • Conventional powered instruments, such as saw’s and craniotomes are also straight rigid instruments that require larger incisions to access the craniofacial skeleton. These instruments can be simple and intuitive to manipulate in surgery with open accessibility, but can be difficult to use in tight areas with sharp turns, such as in the craniofacial area using minimal access incisions.
  • an instrument assembly for navigating a craniofacial skeleton comprising a shaft extending between a proximal end and a distal end, at least a portion of the shaft is articulable; a drive unit operatively coupled to the articulable section of the shaft for controlling movement of the articulable section; and an interchangeable tool having an end-effector, the interchangeable tool operatively coupled to the shaft; wherein in operation, the articulable section is configured to provide at least one degree of freedom of motion to the end-effector.
  • the end-effector may be a unitary tool and may be one of a bone punch, a burr, a scissor, ultrasonic bone cutter, piezoelectric mechanism, a rongeur type mechanism, a laser bone cutter, and a saw.
  • the end effector may be a combination tool and may comprise at least one of a scalp retractor-dissector and a dural retractor-dissector and at least one of a bone punch, a burr, a scissor, ultrasonic bone cutter, piezoelectric mechanism, a rongeur type mechanism, a laser bone cutter, and a saw.
  • the interchangeable tool may comprise an end-effector control system for controlling actuation of the end effector.
  • the end-effector may be a unitary tool and may be one of a scalp retractor-dissector and a dural retractor-dissector.
  • the articulable section of the shaft may comprise a continuum linkage.
  • the at least one degree of freedom of motion may comprise at least two degrees of freedom.
  • the interchangeable tool may comprise an arm, the arm of the interchangeable tool may be joined to the shaft, and the end-effector may be coupled to the arm of the interchangeable tool.
  • the shaft may comprise a channel and the arm of the interchangeable tool may extend through the channel of the shaft.
  • the end-effector of the interchangeable tool may be directly coupled to the shaft.
  • the instrument assembly may further comprise a visualization device.
  • the visualization device may be detachable from the instrument assembly.
  • the visualization device may be an endoscope.
  • the drive unit may be detachable from the shaft.
  • the drive unit may further comprise a motor operatively coupled to the end-effector.
  • the instrument assembly may further comprise a cautery device operatively coupled to the end-effector.
  • the shaft may further comprise a rigid generally straight section and a rigid generally curved section intermediate the proximal end and the articulable section.
  • the end-effector may be a unitary tool and is one of a bone punch, a burr, a scissor, ultrasonic bone cutter, piezoelectric mechanism, and a saw.
  • the end-effector may be a combination tool and may comprise at least one of a scalp retractor-dissector and a dural retractor-dissector and at least one of a bone punch, a burr, a scissor, ultrasonic bone cutter, piezoelectric mechanism, and a saw.
  • the drive unit may be operatively coupled to the articulable section by at least one cable.
  • the instrument assembly may further comprise a mounting assembly for attaching the instrument assembly to a robot manipulator.
  • a guide assembly for navigating a craniofacial skeleton comprising a shaft extending between a proximal end and a distal end, the shaft having a channel for receiving at least a portion of an interchangeable tool, and at least a portion of the shaft is articulable; and a drive unit operatively coupled to the articulable section of the shaft for controlling movement of the articulable section; wherein in operation, the articulable section is configured to provide at least one degree of freedom of motion to the articulable section.
  • the guide assembly may further comprise a flexible conduit joined to the shaft.
  • the guide assembly may further comprise a mounting assembly for attaching the guide assembly to a robot manipulator.
  • the shaft may further comprise a rigid generally straight section and a rigid generally curved section.
  • the instrument assembly may be used for performing craniofacial surgery.
  • the instrument assembly may be used for performing neurosurgery.
  • the instrument assembly may be used for performing any bone cutting procedure.
  • FIG. la depicts a perspective view of a craniofacial surgical instrument assembly, according to a non-limiting embodiment.
  • FIG. lb depicts a left-side view of the craniofacial surgical instrument assembly of FIG. la.
  • FIG. 1c depicts a right-side view of the craniofacial surgical instrument assembly of FIG. la.
  • FIG. Id depicts the craniofacial surgical instrument assembly of FIG. la mounted to a robot manipulator for robotic guided operations, according to a non-limiting embodiment.
  • FIG. 2a depicts a perspective view of a guide assembly and a visualization device of the craniofacial surgical instrument assembly of FIG. la.
  • FIG. 2b depicts the guide assembly and the visualization device of FIG. 2a with an optical tracker of the instrument assembly removed.
  • FIG. 2c depicts the guide assembly of FIG. 2a.
  • FIG. 2d depicts a top view of the guide assembly of FIG. 2c.
  • FIG. 2e depicts a left-side view of the guide assembly of FIG. 2c.
  • FIG. 2f depicts a right-side view of the guide assembly of FIG. 2c.
  • FIG. 2g depicts a transparent view of the guide assembly of FIG. 2f, showing a driving unit of the guide assembly.
  • FIG. 2h depicts a back view of the guide assembly of FIG. 2c.
  • FIG. 3a depicts the guide assembly of FIG. 2c with a bending section of the guide assembly bending at an “upward and straight” position.
  • FIG. 3b depicts the guide assembly of FIG. 2c with a bending section of the guide assembly bending at a “downward-and-righf ’ position.
  • FIG. 3 c depicts a top view of the guide assembly of FIG. 3b.
  • FIG. 3d depicts a side view of the guide assembly of FIG. 2c with a bending section of the guide assembly bending at an “upward-and-righf ’ position.
  • FIG. 3e depicts a top view of the guide assembly of FIG. 3d.
  • FIG. 3f depicts a side view of the guide assembly of FIG. 2c with a bending section of the guide assembly bending at an “upward-and-leff ’ position.
  • FIG. 3g depicts a top view of the guide assembly of FIG. 3f.
  • FIG. 3h depicts a side view of the guide assembly of FIG. 2c with a bending section of the guide assembly bending at an “downward-and-leff ’ position.
  • FIG. 3i depicts a top view of the guide assembly of FIG. 3h.
  • FIG. 3j depicts a left-side side view of the guide assembly of FIG. 3h.
  • FIG. 3k depicts side view of the guide assembly of FIG. 2c with a bending section of the guide assembly bending at an “downward-and-straighf ’ position.
  • FIG. 31 depicts a top view of the guide assembly of FIG. 3k.
  • FIG. 3m depicts a left-side side view of the guide assembly of FIG. 3k.
  • FIG. 4a depicts a shaft section of the guide assembly of FIG. 2a.
  • FIG. 4b depicts a cross-sectional view of a shaft section of the guide assembly of FIG. 2a, taken along line 4b-4b in FIG. 2a.
  • FIG. 4c depicts a cross-sectional view of a shaft section of the guide assembly of FIG. 2a, taken along line 4c-4c in FIG. 2a.
  • FIG. 5a depicts a transparent view of the guide assembly of FIG. 2a, showing a driving unit of the guide assembly.
  • FIG. 5b depicts a partial cross-sectional view of the guide assembly of FIG. 2a, taken along line 5b-5b in FIG. 2d.
  • FIG. 5c depicts the driving unit of FIG. 5a.
  • FIG. 5d depicts a back-view of the driving unit of FIG. 5c.
  • FIG. 6a depicts a right-side view of an interchangeable tool of the craniofacial surgical instrument assembly of FIG. la.
  • FIG. 6b depicts a perspective view of the interchangeable tool of FIG. 6a.
  • FIG. 6c depicts a transparent view of an actuator of the interchangeable tool of FIG. 6a, the actuator is operable to actuate an end-effector of the interchangeable tool of FIG. 6a.
  • FIG. 6d depicts a perspective view of an end-effector of the interchangeable tool of FIG. 6a, the end-effector is a bone punch end-effector.
  • FIG. 6e depicts a transparent view of the bone punch end-effector of FIG. 6d, the bone punch end-effector is shown in an open arrangement.
  • FIG. 6f depicts a transparent view of the bone punch end-effector of FIG. 6d, the bone punch end-effector shown in a closed arrangement.
  • FIG. 7a depicts a perspective view of a burr type end-effector, according to a nonlimiting embodiment.
  • FIG. 7b depicts a side view of the burr type end-effector of FIG. 7a.
  • FIG. 8a depicts a perspective view of a scissors type end-effector, according to a non-limiting embodiment.
  • FIG. 8b depicts a transparent view of the scissors type end-effector of FIG. 8a, the scissors type end-effector shown in an open arrangement.
  • FIG. 8c depicts a transparent view the scissors type end-effector of FIG. 8a, the scissors type end-effector shown in a closed arrangement.
  • FIG. 9a depicts a perspective view of a second example of a craniofacial surgical instrument assembly, according to a non-limiting embodiment.
  • FIG. 9b depicts the craniofacial surgical instrument assembly of FIG. 9a with a visualization device attached thereto.
  • FIG. 9c depicts a side view of the craniofacial surgical instrument assembly of FIG.
  • FIG. 9d depicts a transparent view of the craniofacial surgical instrument assembly of FIG. 9c.
  • FIG. 9e depicts a cross-sectional view of a handle portion of the craniofacial surgical instrument assembly of FIG. 9a, taken along line 9e-9e in FIG. 9a.
  • FIG. 9f depicts a perspective view of the handle portion of the craniofacial surgical instrument assembly of FIG. 9e.
  • FIG. 9g depicts a rear perspective view of a handle portion of the craniofacial surgical instrument assembly of FIG. 9a.
  • FIG. 9h depicts a cross-sectional view of a shaft of the craniofacial surgical instrument assembly of FIG. 9a, taken along line 9h-9h in FIG. 9c.
  • FIG. 9i depicts a cross-sectional view of a shaft of the craniofacial surgical instrument assembly of FIG. 9a, taken along line 9i-9i in FIG. 9c.
  • FIG. 10a depicts a perspective view of an end-effector of the craniofacial surgical instrument assembly of FIG. 9a.
  • FIG. 10b depicts a side view of the end-effector of FIG. 10a, the end-effector shown in an opened position.
  • FIG. 10c depicts a transparent view of the end-effector of FIG. 10b.
  • FIG. lOd depicts a side view of the end-effector of FIG. 10a, the end-effector shown in a closed position.
  • FIG. lOe depicts a bending section of the craniofacial surgical instrument assembly of FIG. 9a bending at an “upward” position.
  • FIG. lOf depicts a bending section of the craniofacial surgical instrument assembly of FIG. 9a bending at a “downward” position.
  • FIG. I la depicts a perspective view of a bending section of a craniofacial surgical instrument assembly, according to a non-limiting embodiment.
  • FIG. 11b depicts a side view of the bending section of FIG. I la bending at an “extended” position.
  • FIG. 11c depicts a side view of the bending section of FIG. I la bending at a “downward” position.
  • FIG. l id depicts an enlarged transparent view of a portion of the bending section of FIG. I la, taken at section l id in FIG. 1 lb.
  • FIG. l ie depicts an enlarged transparent view of a portion of the bending section of FIG. I la, taken at section 1 le in FIG. 11c.
  • FIG. 12a depicts a prototype of the bending section of FIG. I la bending at an “extended” position.
  • FIG. 12b depicts the prototype of the bending section of FIG. I la, bending at a “downward” position.
  • FIG. 13a depicts a perspective view of a craniofacial surgical instrument assembly, according to a non-limiting embodiment.
  • FIG. 13b depicts the craniofacial surgical instrument assembly of FIG. 13 a, shown with a portion of a housing removed.
  • FIG. 13c depicts a side view of the craniofacial surgical instrument assembly of FIG. 13b.
  • FIG. 13d depicts a perspective view of the craniofacial surgical instrument assembly of FIG. 13a, shown with a visualization device attached thereto.
  • FIG. 13e depicts a side view of the craniofacial surgical instrument assembly of FIG. 13 d.
  • FIG. 13f depicts a driving unit of the craniofacial surgical instrument assembly of FIG. 13 a.
  • FIG. 13g depicts a transparent view of the driving unit of FIG. 13f
  • FIG. 13h depicts a perspective view of the driving unit of FIG. 13f
  • FIG. 13i depicts an enlarged perspective view of an end-effector of the craniofacial surgical instrument assembly of FIG. 13 a.
  • FIG. 13j depicts a side view of the end-effector of FIG. 13i.
  • FIG. 13k depicts an enlarged perspective view of the end-effector of FIG. 13i.
  • FIG. 131 is a front view of the end-effector of FIG. 13i with a scalp retractordissector removed therefrom.
  • FIG. 14a depicts a perspective view of a craniofacial surgical instrument assembly, according to a non-limiting embodiment.
  • FIG. 14b depicts an enlarged perspective view of an end-effector of the craniofacial surgical instrument assembly of FIG. 14a.
  • FIG. 15a depicts a perspective view of a simulated workspace overlay on a skull model, according to a non-limiting embodiment.
  • FIG. 15b depicts a side view of the simulated workspace overlay of FIG. 15a.
  • FIG. 15c depicts a top view of the simulated workspace overlay of FIG. 15a.
  • FIG. 15d depicts a simulated workspace analysis of a craniofacial surgical instrument assembly inserted at anterior fontanelle, according to a non-limiting embodiment.
  • FIG. 15e depicts a side view of the simulated workspace analysis of the craniofacial surgical instrument assembly of FIG. 15d, the craniofacial surgical instrument assembly shown along the bone curvature toward the frontal area.
  • FIG. 15f depicts a top view of simulated workspace analysis of the craniofacial surgical instrument assembly of FIG. 15e.
  • FIG. 15g depicts a top view of simulated workspace analysis of the craniofacial surgical instrument assembly of FIG. 15d, the craniofacial surgical instrument assembly shown along the bone curvature toward the frontal right area.
  • FIG. 15h depicts a top view of simulated workspace analysis of the craniofacial surgical instrument assembly of FIG. 15d, the craniofacial surgical instrument assembly shown along the bone curvature toward the frontal left area.
  • FIG. 16a depicts a minimal access incision on the scalp of a sagittal craniosynostosis simulator.
  • FIG. 16b depicts an end effector of a craniofacial surgical instrument assembly approaching the minimal access incision and sagittal craniosynostosis simulator of FIG. 16a.
  • FIG. 16c depicts the craniofacial surgical instrument assembly of FIG. 16b after entry of the sagittal craniosynostosis simulator through the minimal access incision, the instrument assembly shown mounted to a robot manipulator and shown on the display screen is an endoscopic view demonstrating a soft tissue pocket above the skull.
  • FIG. 16d depicts the craniofacial surgical instrument assembly of FIG. 16b after entry of the sagittal craniosynostosis simulator through the minimal access incision, showing the instrument assembly reaching the inferior aspect of the occiput.
  • a bone cutting instrument for example, specifically designed to navigate along the curvatures of the skull and face could provide the capability to perform more extensive osteotomies as well as dissect within soft tissue pockets using minimal access incisions. Such a device could incorporate the advantages of both the endoscopic and open approach, while reducing patient morbidity.
  • Such a device could allow the surgeon to place minimal access incisions and cut bone in any direction along any path over the calvarium and facial bones. Such a device could therefore expand the indications to any type of craniosynostosis, may limit the size of incisions (and scars), and may limit blood loss while allowing for maximal osteotomy extent and limit the need for a molding helmet and an internal assistive device that may require a second procedure for removal post-operatively.
  • Described herein are instruments for use in surgical operations, such as craniofacial surgical operations (including minimally invasive craniosynostosis surgery).
  • the described systems relate to surgical instruments and systems that include, for example, bone cutting tools.
  • the described instruments are capable of articulating/bending to change its path of advancement during surgical operation, such as an osteotomy.
  • the described instruments may perform osteotomies with, for example, punching, shearing, sawing, or burring actuation.
  • the osteotomy treatment is typically carried out in a safe and effective manner along the curvature on the skull bone and facial bones that minimizes or prevents shearing/compression and stress on the scalp, dura, and brain.
  • the described systems are generally directed to overcoming the disadvantages of the standard instruments described above by, according to at least some embodiments, increasing accessibility and visualisation of craniosynostosis surgery.
  • the described instruments can be advantageously used in robotically assisted and/or robotically controlled minimally invasive surgical procedures beyond craniosynostosis around the skull and facial bones as well as along the soft tissues of the scalp and face.
  • the instruments described herein may be used for any type of neurosurgical procedure and in particular, neurosurgical procedures that require skull surgery requiring bone cuts and/or craniotomies.
  • the described instrument assemblies may have at least one of the following features and/or functions:
  • Manual bone cutting end-effectors include, but are not limited to, bone punches, scissors, and rongeur type mechanisms.
  • Powered bone cutting end- effectors include, but are not limited to burrs, saws, ultrasonic bone cutters, and laser bone cutters. The bone cutting end-effector may be interchangeable.
  • a separate visualization device such as an endoscope may be used to visualize the end-effector or a camera may be integrated into the instrument.
  • a working channel for receiving a tool that may be used to (a) create soft tissue tunnels; (b) dissect soft tissue; (c) control bleeding; (d) provide visualization; and/or; (e) remove tissue, under the scalp and facial soft tissues in preparation for the osteotomies.
  • tools include, but are not limited to, graspers, suctionirrigation, cautery, elevators.
  • a manual and/or powered driving unit to control movement of the endeffector.
  • a dural protection mechanism at the end-effector to protect the dura and brain on the endocortical surface of the skull.
  • the device can be remotely controllable using a teleoperated robot and/or may have autonomous features.
  • the device can be used with a collaborate robot manipulator where the tool remains handheld, but may be attached to the collaborative robot manipulator that provides haptic feedback to the user to ensure the tool stays on course and follows pre-defined paths.
  • the assembly can be used in craniosynostosis surgery using minimal access or open incisions to perform extensive cranial and facial bone cuts. 16.
  • the assembly can be used for any craniotomy such as those used in neurosurgical procedure using either minimal access or open incisions.
  • the assembly can be used to make bone cuts in the facial skeleton using minimal access incisions.
  • the assembly can be used to cut any bone within the body including bones of the thorax, spine, pelvis, upper and lower extremities.
  • the assembly may be used for soft tissue only procedures to dissect within soft tissue, elevate soft tissue to access craniofacial regions.
  • the assembly may be used in craniosynostosis surgery to first create a soft tissue pathway above the skull in either a subgalial or subpericranial plane prior to craniotomies. Following creation of soft tissue pockets and pathways the assembly can than be used to perform the craniotomies.
  • the assembly may include interchangeable end-effectors that only perform soft tissue maneuvers that can be changed to end-effectors that perform bone maneuvers.
  • the instrument assembly 100 may include a guide assembly 102, at least one interchangeable tool 104, and at least one visualization device 106.
  • the guide assembly 102 may include a driving unit 108 and a shaft 110.
  • the shaft 110 may extend from a proximal end 114 near the driving unit 108 to a shaft distal end 112.
  • the driving unit 108 may be operable to control movement (e.g., bending, articulation, etc.) of the shaft 110 (described in more detail below).
  • the guide assembly 102 in particular the shaft 110 of the guide assembly 102, may receive (e.g., via at least one channel) and/or may support at least one of the interchangeable tool 104 and the visualization device 106. Accordingly, the guide assembly 102, in particular the shaft 110 of the guide assembly 102, may define a path to a surgical site for the interchangeable tool 104 and/or the visualization device 106 and may control movement of the interchangeable tool 104 and/or the visualization device 106 at/near the surgical site.
  • a portion of the interchangeable tool 104 extends within a channel of the guide assembly 102 and the visualization device 106 is supported by the guide assembly 102.
  • interchangeable tools 104 may be joined to (i.e., receivable by and/or supported by), and therefore at least partially controlled by, the guide assembly 102.
  • the interchangeable tool may be configured as (a) a bone punch 120 as depicted in FIGS. 6d-6f, which may be used to punch and cut a small section of the bone; (b) a burr 122 as depicted in FIGS. 7a and 7b, which may be used to burr bone via continuous rotating actuation; (c) a saw (not shown) which may be used to cut bone; (d) a scissor 124 as depicted in FIG.
  • a scalp retractor-dissector 242 as shown in FIGS. 14a-14b, which may be used to elevate and retract the scalp to create a soft tissue pocket and opening that may allow for visualization of the end-effector and working tools during operation; and/or (f) a dural retractor-dissector 244 which may be used to separate the dura from the endocortical surface of the bone.
  • the interchangeable tool 104 may include an arm 132, and an end-effector 134, and an end-effector control system 136 (examples of various types of end-effectors are described in more detail below).
  • the end-effector 134 may be a unitary tool or a multipurpose/combination tool.
  • the endeffector 134 is a unitary tool and is configured as a bone punch 120.
  • the end-effector 134 is a unitary tool and is configured as a burr 122.
  • the end-effector 134 is a combination tool and which includes each of a burr 128, a scalp retractor-dissector 242, and a dural retractordissector 244.
  • An actuator 130 of the end-effector control system 136 may be operable to actuate the end-effector 134. That is, the operator may signal the end-effector 134 to operate (the specific movement of the end-effector may vary depending on the type of end-effector) via the actuator 130.
  • the end-effector 134 is a bone punch and the actuator 130 is a lever.
  • the lever can be depressed and retracted by an operator and depression and retraction of the lever (i.e., actuation of the actuator 130) causes the bone punch (i.e., the end-effector 134) to open and close. It will be appreciated that other types of actuators 130 may be used.
  • the actuator 130 may be a dial, a foot peddle, a button, a receiver for receiving a signal from a transmitter, etc., and may be mechanical, electric, electromechanical, pneumatic, magnetic, etc. It will be appreciated that some end-effectors 134 may be passive and the interchangeable tool 104 may not require an end-effector control system 136.
  • the interchangeable tool 104 may include an arm 132 as shown in FIG. 6a
  • the arm 132 the of interchangeable tool 104 may be joined to the shaft 110 of the guide assembly 102 (e.g., may extend within a channel of the shaft 110 or may be attached to an exterior to the shaft 110).
  • the arm 132 of the interchangeable tool 104 may move with movement of the shaft 110 of the guide assembly 102.
  • each of the actuator 130, arm 132, and end-effector 134 of the first interchangeable tool 104 may be disconnected from the guide assembly 102 and the second interchangeable tool 104, having an actuator 130, arm 132, and end-effector 134 may be installed in place of the first interchangeable tool 104.
  • the actuator 130 and/or the arm 132 of the interchangeable tool 104 may be integrally formed with the guide assembly 102 (e.g., the arm 132 of the interchangeable tool 104 may be the shaft 110 of the guide assembly 102) and only the end-effector 134 of the interchangeable tool 104 may be interchangeable. Further, it is to be understood that while the interchangeable tool 104 is described herein as interchangeable, in some examples of the instrument assembly 100, the interchangeable tool 104 may not be interchangeable.
  • the instrument assembly 100 may include at least one visualization device 106.
  • the visualization device 106 may allow an operator to visualize the end-effector 134 of the interchangeable tool 104 and target surgical areas when operating the instrument assembly 100.
  • the visualization device 106 may include a distal tip 140 having at least an objective lens, an extension tube, and a display.
  • the visualization device 106 is an endoscope having an eye piece 146.
  • the visualization device 106 may include a camera connected to a digital display (see, e.g., FIG. 16c).
  • the visualization device 106 may be a separate component from the guide assembly 102 and may be detachable from the guide assembly 102.
  • a flexible conduit 142 may extend along the shaft 110 of the guide assembly 102 and may passively bend/move with the shaft 110, and a portion of the visualization device 106 may extend therethrough so that at least a portion of the visualization device 106 moves with the guide assembly 102.
  • the visualization device 106 may be integrally formed with the guide assembly 102. That is, the visualization device 106 may not be separable from the guide assembly 102.
  • the instrument assembly 100 may include a navigational device 144.
  • the navigational device 144 may include an optical system that may determine the position and orientation of the interchangeable tool 104, in particular the end-effector 134 of the interchangeable tool 104, relative to a patient’s anatomy. This may involve registering the instrument assembly 100 to the patient’s anatomy using a vision system such as an optical tracker. Navigation may also involve the utilization of patient imaging (such as a computed tomography (CT) scan) to provide the surgeon with a visualization of the interchangeable tool 104 relative to the patient’s anatomy.
  • CT computed tomography
  • the instrument assembly 100 may include a mounting assembly 150 (see, for example, in FIG. la).
  • the mounting assembly 150 may allow the instrument assembly 100 to be connected to a robot manipulator 152 (see, for example, FIG. Id).
  • the mounting assembly 150 includes a tool side mounting interface 154 and a robot side interface 156.
  • the mounting assembly 150 is coupled to the instrument assembly 100 at the top of the driving unit 108 of the instrument assembly 100.
  • the mounting assembly 150 may be otherwise positioned on the instrument assembly 100.
  • the robot side interface 156 of the mounting assembly 150 may be attached to a robot side mounting interface 158 on a robot manipulator 152 to enable robotic guided operation by the robot manipulator 152.
  • the guide assembly 102 may include a shaft 110 and a driving unit 108 for controlling movement (e.g., bending, articulation, etc.) of the shaft 110.
  • the shaft 110 may comprise a continuum linkage for controlling movement of the shaft 110. It may be desirable for movement of the shaft to be controlled by a continuum linkage (i.e., a type of linkage that is characterised by infinite degrees of freedom and number of joints) so that the shaft can navigate the craniofacial skeleton using a minimal access approach.
  • the entire shaft 110 may be moveable relative to the driving unit 108 (i.e., the entire length of the shaft 110 may be moveable). In other examples, only a portion of the shaft 110 may be moveable relative to the driving unit 108.
  • the shaft 110 may include a moveable bending section 110a (i.e., an articulable section), a rigid generally straight section 110b, and a rigid generally curved section 110c. It may be desirable for the shaft 110 to include a rigid generally straight section 110b and a rigid generally curved section 110c to extend the reach of the shaft 110 and thereby the reach of the end-effector 134 of the interchangeable tool 104 associated with the guide assembly 102.
  • the rigid generally straight section 110b which may be tubular in shape, may help provide a clearance distance between the actuator 130 and/or driving unit 108 and the patient, and hence, may improve maneuverability and may provide the operator with better visualization of the end-effector 134 when the instrument assembly 100 is in use.
  • the generally curved section 110c may help provide a rigid extension that follows the curvature of the flatter part of the skull, allowing the bending section 110a to reach the steeping part of the skull, such as the frontal bone area in craniofacial surgeries, without obstructing the view of the surgical site.
  • the guide assembly 102 may be configured to move the end-effector 134 about one degree of freedom (DOF), two DOFs, three DOFs, four DOFs, five DOFs, six DOFs, seven DOFs, etc.
  • FIG. 9a depicts an example of a guide assembly 102 having one DOF.
  • the example shown in FIG. la has an end-effector 134 movable in two DOFs.
  • the example shown in FIG. 13a has an end-effector 134 movable in four DOFs.
  • the DOFs of the bending section 110a may involve combinations of pitch, yaw, roll, and longitudinal movement, to achieve a desired bending path.
  • FIG. 3 a shows a non-limiting example of a bending section 110a.
  • the bending section 110a is constructed with a continuum linkage 174 having six hinge joints 176 of alternating pitch and yaw.
  • any number of hinge joints 176 may be used, which may be less than or greater than six, and the hinge joints 176 may alternate in pitch and yaw or not.
  • a bending angle between adjacent hinge joints 176 of the continuum linkage 174 may be limited by edges of the hinge joints 176 to prevent the adjacent hinge joints 176 from over bending relative to each other (see, e.g., FIGS. lOe and lOf in which the bending section 230a of this non-limiting embodiment is constructed with three hinge joints 288 at pitch direction and the bending angle is limited by the edges 290, 292 of each link).
  • the curvature of the bending section 110a can be adjusted via the driving unit 108 to conform the shaft 110 to the desired path of the osteotomy or other suitable surgical applications. That is, the driving unit 108 translates an input/signal from the operator to movement of the bending section 110a (e.g., via a mechanical or electromechanical mechanism).
  • the driving unit 108 may be manually operable and/or controlled by embedded actuators controlled by a manually controlled interface (such as joystick, foot peddle, or buttons) and/or software.
  • the driving unit 108 includes a mechanical mechanism that may include, but is not limited to, a cable driven system, a rod system, multiple linked rod system, a multi -backbone driven system, a concentric tube system, an internal motorized system, a pneumatic system, a hydraulic system, a pin jointed system, a multi-link system, and/or a gear driven system.
  • a mechanical mechanism may include, but is not limited to, a cable driven system, a rod system, multiple linked rod system, a multi -backbone driven system, a concentric tube system, an internal motorized system, a pneumatic system, a hydraulic system, a pin jointed system, a multi-link system, and/or a gear driven system.
  • FIGS. 5a-5c depict exploded views of an exemplary driving unit 108 of a guide assembly 102.
  • the driving unit 108 includes two pairs of cables 160a, 160b that extend to the bending section 110a of the shaft 110. Extension and retraction of the cables 160a, 160b causes the bending section 110a to move within two degrees of freedom (pitch and yaw).
  • each pair of cables 160a, 160b may be responsible for one degree of freedom of bending.
  • the cable pairs 160a, 160b may be routed and anchored on a capstan 180, which may be drivingly connected to a respective worm-gear drive 164.
  • Each worm-gear drive 164 may be mounted on a gear shaft 182 (e.g., shaft 182a and shaft 182b), which may be supported by a bearing 184 at both ends to enable rotation thereof.
  • the worm-gear drive 164 and gear shaft 182 may be connected to a turning knob 188 or other suitable driving component, which can be controlled manually or automatically. Therefore, it will be appreciated that rotation of the respective turning knobs 188 may cause extension and/or retraction of the respective cable pairs 160a, 160b. Accordingly, rotation of the turning knobs 188 may control movement of the bending section 110a.
  • a rotatory encoder (not shown) maybe installed to the worm gear drive 164 and/or gear shaft 182 to provided digital feedback to an operator about the bending angle of the bending section 110a.
  • the shaft 110 may be hollow so that, for example, cables for controlling bending (e.g., cables 160a, 160b), an interchangeable tool arm 132, and/or cables connected to an end-effector may be passed through the shaft 110 towards the distal end 112 of the shaft 110.
  • cables for controlling bending e.g., cables 160a, 160b
  • an interchangeable tool arm 132 e.g., cables 160a, 160b
  • cables connected to an end-effector may be passed through the shaft 110 towards the distal end 112 of the shaft 110.
  • At least one flexible conduit 142 may be joined to the shaft 110 and may move with movement of the shaft 110. As described above, it may be desirable to join at least one flexible conduit 142 to the shaft 110 to allow for, for example, an endoscope to pass therethrough.
  • the flexible conduit 142 may house an interchangeable tool arm 132, light source, or another tool type.
  • the instrument assembly 100 may include multiple flexible conduits 142 joined to the shaft 110. According to some embodiments, the flexible conduit(s) 142 may be attached to the shaft 110 by multiple retainer rings, such as rings 192.
  • a mount frame 198 is available for the visualisation device 106, such as a flexible endoscope, to attach onto the instrument 100 (see FIG. la).
  • the instrument assembly 100 may include an end-effector 134 positioned at the distal end 112 of the shaft 110.
  • the end-effector 134 may be a component of an interchangeable tool 104 that includes an arm 132 that is separate from the shaft 110 (i.e., the end-effector 134 may be indirectly coupled to the shaft 110), or the end-effector 134 may be a component of an interchangeable tool 104 that does not have a separate arm 132 from the shaft 110 (i.e., the end-effector 134 may be directly coupled to the shaft 110).
  • the end-effector 134 may or may not be interchangeable.
  • the end-effector 134 may be a unitary tool or a combination tool. Accordingly, the end-effector 134 (or at least one tool of a combination tool type endeffector 134) may be integrally formed with and/or rigidly coupled to the shaft 110 of the guide assembly 102. Alternatively, the end-effector 134 (or at least one tool of a combination tool type end-effector 134) may be removably attached to the shaft 110 of the guide assembly 102 or attached to an arm 132 of an interchangeable tool 104 that passes along the shaft 110. It will be appreciated that combination tool type end-effectors may have a tool that is rigidly coupled to the shaft 110 and a tool that is attached to an arm 132 of an interchangeable tool 104 that passes along the shaft 110.
  • Non-limiting examples of an end-effector 134 include a bone punch 120, rongeur type of mechanism, scissors 124, burr 122, graspers, forceps, cautery, suction-irrigation, saws, elevators, dissection tools, needle drivers, scalp retractor-dissectors 242, dural retractors-dissectors 244, ultrasonic mechanisms, lasers, or any energy mechanism that can cut bone.
  • movement (i.e., pitch, yaw, roll) of the end-effector 134 may be controlled by the guide assembly 102, in particular, the bending section 110a of the shaft 110 of the guide assembly 102.
  • Operation of the end-effector 134 may be controlled by a manual and/or a powered end-effector control system 136.
  • the end-effector control system 136 may translate an input from the operator to movement and/or actuation of the end-effector 134.
  • the endeffector control system 136 may be spatially separated from the end-effector 134 and may be connected thereto by cables (or rods or other linking mechanisms) that impart tension to control movement of the end-effector 134.
  • the end-effector control system 136 may be positioned proximate the end-effector 134.
  • actuation of the end-effector 134 may be driven by an end-effector control system 136 having an electric motor.
  • actuation of the end-effector 134 at the distal end 112 of the shaft 110 of the guide assembly 102 is driven by an end-effector control system 136 configured as a lever 202 positioned proximate a handle 204 of instrument assembly 100.
  • the end-effector control system 136 of the instrument assembly 100 of FIG. lb is illustrated.
  • the end-effector control system 136 may comprise a linkage mechanism 206 which is triggered by the lever 202.
  • An actuation cable 210 may be routed and anchored on a sliding bar 212 in the handle 204.
  • the sliding bar 212 may be constrained by a linear guide 214 in the handle 204 such that it can only slide longitudinally in the direction of the handle 204.
  • linear guide 214 may include a slot 216.
  • the linkage mechanism 206 pushes the sliding bar 212 backward and hence pulls the actuation cable 210 which causes the end-effector 134 to close.
  • the spring 218, or other suitable biasing element(s) at the rear end of the sliding bar 212 pushes the sliding bar 212 back to its original position which causes the end-effector 134 to open.
  • a linkage mechanism 220 such as a three-bar linkage mechanism 222, may be used to translate linear motion of the actuation cable 210 to actuation of the end-effector 134.
  • the three-bar linkage mechanism 222 has a proximal link 222a, an intermediate link 222b, and a distal link 222c.
  • the actuation cable 210 may extend from the lever 202 to the proximal link 222a.
  • the intermediate link 222b and distal link 222c may be pivotally connected in series to proximal link 222a.
  • the distal link 222c may be pivotally fixed in place.
  • retraction of the actuation cable 210 may cause distal link 222c to pivot which may be considered actuation of the end-effector (i.e., the upper jaw 228 may rotate towards the lower jaw 226).
  • one of the upper jaw 228 and lower jaw 226 may be passive and may not move during actuation of the endeffector.
  • the end-effector 134 may be configured such that each of the upper and lower jaws 228, 226 move.
  • the bone punch 120 may be configured to perform a cautery function.
  • the instrument assembly 100 may further comprise a cautery device separate from the bone punch 120. Having the ability to cauterize the tissue may allow for dissection of the subcutaneous tissue and control of bleeding.
  • the instrument assembly 100 may further comprise a suction and/or irrigation system. Having a suction and/or irrigation system may improve visualization during use of the instrument assembly 100. Having additional functionality may help ensure the instrument assembly 100 stays in-Situ to perform all necessary steps of the operation being performed including creating a subcutaneous pocket above the skull and facial bones, dissection under the skull between the dura and skull allowing for bone cutting along this dissected path.
  • the end-effector control system 136 may include a motor.
  • the motor may be integrated in the handle 204 and the power may be transmitted to the end-effector 134 through a flexible conduit that extends through or along shaft 110.
  • the rotations per minute (RPM) of the motor may be controlled by the end-effector control system 136.
  • RPM rotations per minute
  • the amount a button or lever is pressed may be proportional to the speed of the motor. It is to be understood that any end-effector 134 that has moving components may be controlled and/or partially controlled by a motor.
  • the end-effector may be a scalp retractor-dissector 242 and/or a dural -protector-dis sector 244, which may help protect the scalp and the dura from being damaged by other components of the instrument assembly during use thereof.
  • the scalp retractor-dissector 242 may have the shape of an elevator.
  • the scalp retractor-dissector 242 of the instrument assembly may have at least one of two functions.
  • One function may be to operate as an elevator and dissector to separate tissue layers.
  • the scalp retractor-dissector 242 may separate between the pericranium and bone to operate within a subpericranial space or between the galea and pericranium in a subgalial space.
  • the dissection and elevation of soft tissue within these two spaces can be performed as a separate step prior to performance of bone cuts.
  • the scalp retractor-dissector 242 may be used as a unitary tool to create a soft tissue pocket and path for bone cutting.
  • the dissection and elevation of soft tissue can be performed simultaneously with bone cutting. That is, the scalp retractor-dissector 242 may be co-located with a bone cutting tool at the distal end 112 of the shaft 110 (i.e., be a component of a combination tool type endeffector).
  • an end-effector 134 may be a unitary tool and configured as a scalp retractor-dissector 242 and in other examples, an end-effector 134 may be configured as a combination tool having a scalp retractor-dissector 242 and at least one other tool (e.g., a bone punch 120, rongeur type of mechanism, scissors 124, burr 122, graspers, forceps, cautery, dural retractor-dissector suction-irrigation, saws, ultrasonic mechanisms, lasers, or any energy mechanism that can cut bone).
  • a bone punch 120 rongeur type of mechanism
  • scissors 124 rongeur type of mechanism
  • burr 122 graspers
  • forceps cautery
  • dural retractor-dissector suction-irrigation saws, ultrasonic mechanisms, lasers, or any energy mechanism that can cut bone.
  • advancement of the instrument assembly may allow for separation of the soft tissue (in either a subpericranial or subgalial space) via the scalp retractor-dissector 242 and for performance of the osteotomies.
  • a second function of the scalp retractor-dissector 242 may be to act as a retractor of the soft tissue to maintain a soft tissue pocket or cavity that allows for visualization of the operative site.
  • the dural retractor-dissector 244 may have the shape of an elevator.
  • the dural retractor-dissector 244 may have two functions. One function may be to separate the dura from the inner surface (endocortical) of the skull to create a safe pathway for the instrument assembly to perform bone cuts.
  • the dural retractor-dissector 244 may be a unitary (stand alone) end-effector or may be used in combination with another tool (i.e., be configured as a combination tool.
  • the end-effector may include (a) only one of a scalp retractor-dissector 242 and a dural retractor-dissector 244; (b) both a scalp retractor-dissector 242 and a dural retractor-dissector but no other end-effectors; (c) only one of a scalp retractor-dissector 242 and a dural retractor-dissector 244 in combination with another tool; or (d) a scalp retractor-dissector 242 and a dural retractordissector 244 and at least one other tool.
  • the dissection and elevation of the dura away from the skull can be performed as a separate step whereby the epidural space is created first to allow for safe osteotomies. This separation can also be performed while the osteotomies are being performed simultaneously.
  • the dissector can be a separate interchangeable tool that acts only as a dural dissector. The second function of the protector-dissector is to protect the dura and brain while the osteotomies are performed.
  • the instrument assembly 100 may be connectable to a robot manipulator 152.
  • Any robot manipulator 152 known in the art capable of supporting and positioning the instrument assembly 100 may be used.
  • the robot manipulator 152 is a DENSO robot manipulator with 6 DOFs.
  • the robot manipulator 152 may be a collaborative robot manipulator.
  • the robot manipulator 152 may be tele-operated whereby the operator sits at a console to remotely control the robot manipulator 152 and the position and orientation of the tool assembly 100.
  • the entire instrument assembly may be configured as a stand-alone robot manipulator where the components of the instrument assembly are integrated into a robotic manipulator.
  • FIG. 9a shows another example of a craniofacial surgical instrument assembly 100b, according to non-limiting embodiments.
  • This example combines the guide assembly 102, flexible conduit 142, and interchangeable tool 104 to a singular shaft 230.
  • the singular shaft 230 may have a smaller cross-sectional area compared to the combination of the shaft 110 and flexible conduit 142 as shown in FIG. la, which may help further reducing invasiveness.
  • a flexible conduit like flexible conduit 142 shown in FIG. la, could be joined to the shaft 230.
  • the instrument assembly 100b may comprise a driving unit 232 with turning knob 234, an elongated shaft 230 with a straight section 230c and a curved section 230b, a bending section 230a, an end-effector 134 having a bone punch, a scalp retractor-dissector 242 and dural retractor-dissector 244, a handle 246, an actuation lever 248, and a visualization device channel 250.
  • a driving unit 232 with turning knob 234 an elongated shaft 230 with a straight section 230c and a curved section 230b, a bending section 230a, an end-effector 134 having a bone punch, a scalp retractor-dissector 242 and dural retractor-dissector 244, a handle 246, an actuation lever 248, and a visualization device channel 250.
  • the instrument assembly 100b is shown with a detachable visualization device 352 (an endoscope in the example shown) joined thereto.
  • the detachable visualization device may include a clamp 350 configured to attach the visualization device to the handle 246 of the instrument assembly 100b.
  • the visualization device may be integrated with the handle 246.
  • the bending degree of freedom is simplified to pitch only (e.g., flexure about the pitch axis).
  • the bending degree of freedom may be simplified to yaw only (e.g., flexure about the yaw axis).
  • the bending degree of freedom may include pitch, yaw, and/or roll.
  • FIGS. 9d-9e an example of a driving unit 232 for controlling movement of the bending section 230a of the shaft 230 and an end-effector control system 278 for controlling end-effector actuation is shown.
  • a pair of cables 252 that control movement of the bending section 230a is routed by a set of pulleys 254 and are anchorage on a capstan 256 which is drivingly coupled to a worm-gear drive 258.
  • the worm gear 258 may be driven manually by the turning knob 234.
  • the gear shafts 260 supporting the worm gear 258 may be supported by a bearing 262 at each end.
  • actuation of the end-effector 134 is controlled by pushing and/or pulling a cable 264 which is connected to a sliding bar 266 in the handle 246.
  • the sliding bar 266 may be constrained by a linear guide 268, such that the sliding bar 266 will move backward and pull the cable 264 when the lever 248 is pressed and push the cable 264 when the lever is released.
  • FIGS. 9h-9i A cross-section view of the elongated shaft 230 of this example embodiment of instrument 100b is shown in FIGS. 9h-9i, indicating an example arrangement of the visualization device channel 250, the two channels 272, 274 at top and bottom for the cable pair 252 for controlling movement of the bending section 230a, and the channel 276 at the side for cable 264 for actuating the end-effector 134.
  • FIG. 10a shows an opening 286 that may be positioned proximate to the end-effector 134 for distal end of a visualization device to protrude out from.
  • the bending section 300 includes five links 302a, 302b, 302c, 302d, 302e connected in series.
  • a similar bending section may include more or less than five links.
  • adjacent links 302 may be connected by respective pin joints 304.
  • the pin joints 304 allow for adjacent links 302 to rotate (bend) relative to each other.
  • a pair of linkage cables 306a, 306b extend between pairs of gapped adjacent links 302 (i.e., every other link 302) (e.g., links 302a and 302c in the example illustrated).
  • the linkage cables 306a, 306b may be non-stretchable and rigid in length. As shown in FIG.
  • a first distal end 308a of the first linkage cable 306a may be fixed to a first side 310 of a first link 302a and a second distal end 308b of the first linkage cable 306a may be fixed to a second side 312 of a gapped adjacent link 302c.
  • a first distal end 314a of the second linkage cable 306b may be fixed to a second side 316 of the first link 302a and a second distal end 314b of the second linkage cable 306b may be fixed to a first side 318 of the third link 302c. As shown in FIG.
  • each of the first linkage cable 306a and second linkage cable 306b may pass through a channel 320 in the gapped link (i.e., intermediate link) (e.g., link 302b in the example illustrated) as they traverse from first/second sides 310, 316 of the first link 302a to first/second sides 312, 318 of the third link 302c.
  • the gapped link i.e., intermediate link
  • a pair of actuation cables 320a, 320b extend along a length of the bending section 300.
  • a distal end 322, 324 of each of the actuation cables 320a, 320b may be fixed to a distal link 344 (link 302e in the example illustrated) of the bending section 300.
  • bending of the bending section 300 may be controlled by applying a force and pulling one of the actuation cables 320a, 320b. That is, with reference to FIG.
  • a bending section 300 as constructed as described above may bend such that bending angles between each pair of adjacent links within the bending segment 300 are approximately equal, or equal, when a force is applied to one of the actuation cables 320a, 320b.
  • the bending section shown in FIGS. I la to l ie may only bend about the pivot joints 304
  • the pivot joints 304 may be replaced with a ball joint (and/or additional pivot joints having a different bending axis may be used) so that the bending section may be bendable in multiple directions (e.g., up, down, left, right).
  • more than two actuation cables may be used to control the bending movements and more than two linkage cables may extend between adjacent links.
  • the linkage cables 306a, 306b and actuation cables 320a, 320b may be constructed from any material known in the art having a high tensile strength and resistant to bending fatigue, for example, stainless steel 316 and/or tungsten.
  • the actuation cables 320a, 320b may be controlled by any driving unit known in the art.
  • the driving unit may include servo motors, gearboxes, capstans, and pulleys which may be operable to retract and protract the actuation cables.
  • each actuation cable 320a, 320b may be linked to a respective capstan-motor module. Accordingly, the two motors can function as a variable stiffness robot joint actuator, enabling the adjustment of stiffness over a wide range through tendon tensions.
  • FIG. 13a shows another example of a craniofacial surgical instrument assembly 100c.
  • the instrument assembly 100c is different from assembly 100 and 100b in that the instrument assembly 100c includes a detachable coupling interface 360 to the driving unit 362; three separate tool channels (visualization device channel 364; suction irrigation channel 366; and additional tool channel 368) and their respective insertion port (visualization device port 370; suction irrigation port 372; and additional tool port 374); and a detachable end-effector 134 as well as additional degrees-of-freedom.
  • the guide assembly 382 of the instrument assembly 100c has four DOFs.
  • the four DOFs of the guide assembly 100c include pitch in large radius 384, pitch in medium radius 386, and pitch and yaw in short radius 388. It will be appreciated that in other examples, each of the large radius 284, medium radius 286, and the short radius 388 may include pitch and/or yaw.
  • FIGS. 13d-13e show the surgical instrument assembly 100c with a visualization device 390 attached thereto.
  • the detachable coupling interface 360 is illustrated.
  • the driving unit 362 within the coupling interface 360 may comprise four capstans 392 that can drive the cables for the four DOFS of the bending section 300.
  • the driving actuator(s) 394 for controlling actuation of the end-effectors 134 may transmit rotation or linear motion, depending on the type of end-effector 134 that is used.
  • FIGS. 15a-15c an example workspace simulation of a skull model 396 is shown, and FIGS. 15a-15c indicate the areas 398 that the end-effector of the instrument can reach and perform surgical operations from a single incision 404.
  • FIGS. 15d-l 5h the craniofacial surgical instrument assembly 100b demonstrates its reachability within the workspace with a skull model overlayed, while conforming to the curvature of the skull.
  • the workspace analysis shows the capability of this invention to perform surgeries in wide area and minimize the invasiveness of the operation.
  • the materials used to construct the instrument assembly may comprise of a combination of metal (e.g., aluminium, steel, stainless steel, brass, copper, titanium, nickel titanium alloy), rigid plastic (e.g., PLA, ABS) and flexible plastic (e.g., polyethylene).
  • metal e.g., aluminium, steel, stainless steel, brass, copper, titanium, nickel titanium alloy
  • rigid plastic e.g., PLA, ABS
  • flexible plastic e.g., polyethylene
  • the small structural supporting parts such as the shaft and end-effector of the guide assembly may be made of aluminum
  • the cable used for the force transmission mechanism may be made of stainless steel cable, which could be replaced with other high strength materials such as tungsten.
  • the gears used in the driving unit may be made of metal such as brass.
  • Larger structural parts such as the housing of the driving unit and the handle can be constructed with rigid plastic like polylactic acid (P A) or acrylonitrile butadiene (ABS), which could be 3D printed, machined, or injection molded. Flexible material may be used for passive bending parts such as the flexible channel.
  • P A polylactic acid
  • ABS acrylonitrile butadiene
  • the instrument assembly as described above may be used in a sequence of steps in which the instrument assembly may be used to manipulate both soft and hard (bone) tissue. Prior to performing osteotomies, the instrument may be used to free scalp soft tissue and dura to ensure the instrument assembly is in the correct plane and that soft tissue pathways have been created prior to performing osteotomies.
  • the scalp soft tissue dissection can be performed by the instrument assembly by dissecting and elevating tissue within a subpericranial space or within a subgalial space.
  • the instrument assembly with its articulating bending mechanism may allow for performance of soft tissue dissection using minimal access incisions to the extent required to perform the required osteotomies.
  • Soft tissue dissection can be performed in two ways. The full extent of the soft tissue dissection required can be performed prior to performance of the osteotomies. This can be done using an end-effector configured solely as a scalp retractor-dissector or using a combination end-effector (e.g., an end-effector having a tool (e.g., a bone cutter) and a scalp retractor-dissector).
  • the dural dissection can be performed by the instrument assembly by separating the dura from the inner surface of the skull. This can be performed as an initial step to free the dura along all the planned osteotomy extents using the dural retractordissector or using a separate interchangeable dural elevator that can attach to the device.
  • the articulating bending section may allow for dural separation within the epidural space along an extent not possible with existing instruments through a single burr hole. Separation of the dura from the endocortical space using a single burr hole requires utilization of a visualization system that traverses with the elevator in the epidural space.
  • the scalp soft tissue dissection and dural dissection can also be performed during the performance of the osteotomies in a step-wise function.
  • the instrument assembly may be advanced along the planned osteotomy and may perform the dural dissection and scalp dissection (subgalial or subpericranial) simultaneously.
  • the following functions may be performed simultaneously or in near simultaneous fashion. This involves, dissection of the dura from the bone using the dural retractor-dissector, protection of the dura and brain using a dural retractor-dissector, elevation of the scalp in the subgalial or subpericranial space using the scalp retractor-dissector and performance of the osteotomies.
  • the performance of the osteotomies may be aided by the utilization of a navigational device to localize the instrument assembly, and particularly the end-effector of the instrument assembly, with respect to the craniofacial anatomy.
  • Planned osteotomies with the aid of navigation may allow for the performance of scalp soft tissue and dural dissection along pre-determined paths ensuring the paths are accurate with respect to patient anatomy.
  • the osteotomies can than be performed using the navigational device to ensure they follow pre-determined paths relative to patient anatomy.
  • the instrument can perform suction-irrigation during soft tissue dissection to maintain the visual field as well as during bone cutting to ensure the visual field is maintained and to clear bone debris after cutting.
  • a working channel may allow for the utilization of graspers, which may be needed to remove tissue pieces or to interact with the tissue.
  • graspers which may be needed to remove tissue pieces or to interact with the tissue.
  • Cautery which can be integrated into a stand-alone cautery or as part of a metallic instrument can be used to obtain hemostasis.
  • the integration of the instrument assembly with a robotic manipulator that is either teleoperated or acting as a collaborative robot may ensure that pre-determined paths are followed and maintained during operation.
  • An additional utilization of the device is the performance of osteotomies with the device operating within the epidural space. This would involve the performance of a bunhole with the device entering the burr hole in the epidural space. The device would than be required to separate the dura from the inner surface of the skull to create safe epidural spaces along the planned osteotomies. The tool would than perform the osteotomies while visualizing from within the epidural space.
  • a component that is configured to or enabled to perform a function is configured to or enabled to perform the function, or is suitable for performing the function, or is adapted to perform the function, or is operable to perform the function, or is otherwise capable of performing the function.
  • components in the present application may be described as being “operatively connected to”, “operatively coupled to”, and the like, to other components. It is understood that such components are connected or coupled to each other in a manner to perform a certain function. It is also understood that “connections”, “coupling” and the like, as recited in the present application include direct and indirect connections between components.
  • references in the application to "one embodiment”, “an embodiment”, “an implementation”, “a variant”, etc., indicate that the embodiment, implementation or variant described may include a particular aspect, feature, structure, or characteristic, but not every embodiment, implementation or variant necessarily includes that aspect, feature, structure, or characteristic. Moreover, such phrases may, but do not necessarily, refer to the same embodiment referred to in other portions of the specification. Further, when a particular aspect, feature, structure, or characteristic is described in connection with an embodiment, it is within the knowledge of one skilled in the art to affect or connect such module, aspect, feature, structure, or characteristic with other embodiments, whether or not explicitly described. In other words, any module, element or feature may be combined with any other element or feature in different embodiments, unless there is an obvious or inherent incompatibility, or it is specifically excluded.
  • the term "about” can refer to a variation of ⁇ 5%, ⁇ 10%, ⁇ 20%, or ⁇ 25% of the value specified.
  • “about 50" percent can in some embodiments carry a variation from 45 to 55 percent.
  • the term “about” can include one or two integers greater than and/or less than a recited integer at each end of the range. Unless indicated otherwise herein, the term “about” is intended to include values and ranges proximate to the recited range that are equivalent in terms of the functionality of the composition, or the embodiment.
  • ranges recited herein also encompass any and all possible sub-ranges and combinations of sub-ranges thereof, as well as the individual values making up the range, particularly integer values.
  • a recited range includes each specific value, integer, decimal, or identity within the range. Any listed range can be easily recognized as sufficiently describing and enabling the same range being broken down into at least equal halves, thirds, quarters, fifths, or tenths. As a non-limiting example, each range discussed herein can be readily broken down into a lower third, middle third and upper third, etc.

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  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
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  • Robotics (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne des exemples d'ensembles instrument utilisés pour se déplacer dans un squelette cranio-facial au cours d'une opération de craniosynostose. Dans certains exemples, l'ensemble instrument peut comprendre : (a) une tige s'étendant entre une extrémité proximale et une extrémité distale, au moins une partie de la tige pouvant être articulée ; (b) une unité d'entraînement accouplée de manière fonctionnelle à la section d'articulation de la tige pour commander le mouvement de la section d'articulation ; et (c) un outil interchangeable avec un effecteur terminal et un système de commande d'effecteur terminal pour commander l'actionnement de l'effecteur terminal. L'outil interchangeable peut être accouplé de manière fonctionnelle à la tige. Lors de l'utilisation, la section articulée peut être configurée pour fournir au moins un degré de liberté de mouvement à l'effecteur terminal.
PCT/CA2024/050074 2023-01-23 2024-01-23 Ensemble instrument chirurgical articulé et ses utilisations Ceased WO2024156054A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US202363440470P 2023-01-23 2023-01-23
US63/440,470 2023-01-23
US202363537017P 2023-09-07 2023-09-07
US63/537,017 2023-09-07
US202463619083P 2024-01-09 2024-01-09
US63/619,083 2024-01-09

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20250169829A1 (en) * 2022-03-21 2025-05-29 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Surgical Drill for Craniosynostosis and Endoscopic Procedures

Citations (4)

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Publication number Priority date Publication date Assignee Title
US20080064921A1 (en) * 2006-06-13 2008-03-13 Intuitive Surgical, Inc. Guide tube control of minimally invasive surgical instruments
US20190000466A1 (en) * 2017-06-28 2019-01-03 Ethicon Llc Surgical instrument comprising an offset articulation joint
WO2019000090A1 (fr) * 2017-06-26 2019-01-03 The Hospital For Sick Children Outil chirurgical agile 4-dof pour articulation compacte
WO2020154596A1 (fr) * 2019-01-24 2020-07-30 Noah Medical Corporation Dispositifs à usage unique avec capacités de vision intégrées

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080064921A1 (en) * 2006-06-13 2008-03-13 Intuitive Surgical, Inc. Guide tube control of minimally invasive surgical instruments
WO2019000090A1 (fr) * 2017-06-26 2019-01-03 The Hospital For Sick Children Outil chirurgical agile 4-dof pour articulation compacte
US20190000466A1 (en) * 2017-06-28 2019-01-03 Ethicon Llc Surgical instrument comprising an offset articulation joint
WO2020154596A1 (fr) * 2019-01-24 2020-07-30 Noah Medical Corporation Dispositifs à usage unique avec capacités de vision intégrées

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20250169829A1 (en) * 2022-03-21 2025-05-29 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Surgical Drill for Craniosynostosis and Endoscopic Procedures

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