WO2019202320A1 - Dispositif de mesure angulaire d'outil chirurgical - Google Patents

Dispositif de mesure angulaire d'outil chirurgical Download PDF

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Publication number
WO2019202320A1
WO2019202320A1 PCT/GB2019/051095 GB2019051095W WO2019202320A1 WO 2019202320 A1 WO2019202320 A1 WO 2019202320A1 GB 2019051095 W GB2019051095 W GB 2019051095W WO 2019202320 A1 WO2019202320 A1 WO 2019202320A1
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WO
WIPO (PCT)
Prior art keywords
surgical
tool
surgical tool
measurement device
angular measurement
Prior art date
Application number
PCT/GB2019/051095
Other languages
English (en)
Inventor
Eric Renault
Original Assignee
Corin Limited
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 Corin Limited filed Critical Corin Limited
Publication of WO2019202320A1 publication Critical patent/WO2019202320A1/fr

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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
    • A61B90/06—Measuring instruments not otherwise provided for
    • 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
    • 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 or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4657—Measuring instruments used for implanting artificial joints
    • 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
    • A61B2034/2048—Tracking techniques using an accelerometer or inertia sensor
    • 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/067—Measuring instruments not otherwise provided for for measuring angles
    • 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 or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4657—Measuring instruments used for implanting artificial joints
    • A61F2002/4668—Measuring instruments used for implanting artificial joints for measuring angles

Definitions

  • the present invention relates to a surgical-tool angular measurement device for removable attachment to a surgical tool.
  • the invention further relates to a surgical system for use in total hip arthroplasty and a method of orienting a surgical tool in a total hip arthroplasty procedure.
  • Total hip arthroplasty is a procedure for the treatment of arthritis of the hip, a condition which causes considerable pain and loss of movement.
  • the hip is a ball and socket joint which allows the upper leg to move from side to side, back to front, and to rotate.
  • the joint is made up of the head of the femur, the ball, which fits into the acetabulum, the socket.
  • the hip joint may be required to be replaced with an acetabular cup aligned with, inserted into and attached to the acetabulum.
  • a replacement femoral head is attached to the body of the femur and is inserted into the acetabular cup.
  • the acetabular cup may conventionally be aligned with the acetabulum with reference to an anteversion angle and an inclination angle. This may typically be done by the surgeon by eye or by palpation which can result in a less precise alignment of the acetabular cup.
  • angular measurement devices are known which can assist with the alignment of the acetabular cup; however these can be unreliable and/or inaccurate
  • the present invention seeks to provide a solution to these problems.
  • a surgical-tool angular measurement device for removable attachment to a surgical tool, the device comprising a housing, and an inertial measurement element having one or more inertial sensors and/or magnetometers, the housing including fastening means for removable engagement with a surgical tool, acceleration damping means for damping undesirable linear and/or rotational acceleration imparted by said surgical tool.
  • the inertial measurement element and the ability to removably engage the surgical-tool angular measurement device with a surgical tool allows for said surgical tool to be orientated with respect to a patient, in particular being correctly orientated with the acetabulum, or other surgical site, and therefore for reaming or acetabular cup insertion to be carried out at a desired orientation.
  • the acceleration damping means allows for the inertial measurement element to be attached to the surgical tool without affecting the accuracy or reliability of the determination of the angular orientation by the inertial sensors and/or magnetometers. This is due to the acceleration damping means reducing the impact, force or acceleration when attaching the device to the surgical tool. High acceleration or force acting on inertial sensors is associated with less accurate angular measurements. Acceleration damping for the angular measurement device may also be required if the surgical tool is used to hammer, ream or otherwise physically interact with the patient in a forceful manner.
  • the damping means makes it possible to use the inertial measurement element in the measuring ranges where it is the most sensitive and has the best precision.
  • inertial sensors typically have different sensitivity ranges.
  • accelerometers may have sensitivity ranges of +/- 2, +/- 4, +/- 8, +/- 16 g and gyroscopes may have sensitivity ranges of +/- 125, + / - 250, +/- 500, +/- 1000, +/- 2000 degrees per second (dps).
  • the most accurate measurements are obtained using the smallest possible measurement ranges.
  • the measurement performed during total hip arthroplasty is typically performed with very low accelerations of less than 1 g and low angular velocities of less than 250 dps.
  • the damping means enables the use of sensors of smaller sensitivity ranges by fdtering, preventing or limiting background or unintentional accelerations greater than the measurement ranges selected. This maintains better sensitivity, and therefore accuracy, for angle measurements.
  • the housing may include a tray adapted to receive the inertial measurement element, the tray having one or more sides and a base, the fastening means and/or the acceleration damping means extending from the base of the tray.
  • a tray having sides and a base allows for the inertial measurement element to be held by the housing.
  • the acceleration damping means and/or fastening means extending from the base of the tray allows for the inertial measurement element to be spaced apart from the point of attachment of the surgical -tool angular measurement device with the surgical tool.
  • the acceleration damping means may include a plurality of mounting members interconnecting the tray and fastening means.
  • a plurality of spaced apart mounting members is able to damp smaller accelerations, vibrations or forces and or more effectively damp than a single mounting member.
  • At least one of the mounting members may be any one of cylindrical, substantially cylindrical, tubular, substantially tubular, a straight or curvate blade.
  • a tubular mounting member is able to damp smaller accelerations, vibrations or forces and or more effectively damp than a single mounting member.
  • a curvate blade shaped mounting member is able to directionally dampen accelerations and therefore can be more effective at damping accelerations in a given direction than non curvate mounting members.
  • the acceleration damping means may include the tray, the tray having an inner tray element adapted to receive the inertial measurement element, and an outer tray element attached to the inner tray element and disposed therearound, the outer tray element interposing the mount and the inner tray element.
  • An inner and outer tray provides damping without necessarily extending the separation of the inertial measurement element and the surgical tool. This therefore provides a more compact arrangement than if arranged otherwise.
  • the fastening means may include a plurality of magnetic elements adapted to engage with the surgical tool. Magnetic elements provide a releasable fastening means which may be attachable faster than other typical fastening means.
  • the acceleration damping means may include a directional damping element on a surgical- tool engaging surface of the mount.
  • the directional damping element such as a flexible blade, provides directional damping which can be more effective at damping accelerations in a given direction than non- directional mounting members.
  • the fastening means may be a mount having any one of a curvate, V-shaped, or L- shaped profile being at least in part adapted to receive a shaft of the surgical tool.
  • a range of profiles of the fastening means enables the surgical-tool angular measurement device to be adapted for connection to surgical tools of various cross-sections.
  • the plurality of inertial sensors may include at least one three-axis accelerometer and at least one three-axis gyroscope.
  • An accelerometer can provide an indication of the direction of gravity and therefore an indication of the surgical tool’s orientation with respect to gravity.
  • a gyroscope can detect the angular rotation of the surgical tool.
  • a surgical system for use in total hip arthroplasty comprising: a surgical tool adapted to engage an implant at or adjacent to an acetabulum of a patient; and a surgical-tool angular measurement device preferably in accordance with the first aspect of the present invention, for removable attachment to the surgical tool, the device comprising a housing, and an inertial measurement element having one or more inertial sensors and/or magnetometers, the housing including fastening means for removable engagement with a surgical tool, and acceleration damping means for damping undesirable linear and/or rotational acceleration when attaching the device to said surgical tool and/or when the surgical tool is impacted.
  • the damping means allows the inertial measuring element to be used in the smallest measurement ranges of the accelerometer and gyroscope, to maximise precision.
  • the surgical system may further comprise an electronic display device communicatively connected to the surgical-tool angular measurement device.
  • An electronic display device enables the orientation of the surgical tool to be displayed to the surgeon to allow the surgical tool to be orientated correctly.
  • the plurality of inertial sensors may include at least one 3 -axis accelerometer and at least one 3 -axis gyroscope.
  • An accelerometer can provide an indication of the direction of gravity and therefore an indication of the surgical tool’s orientation with respect to gravity.
  • a gyroscope can detect the angular rotation of the surgical tool.
  • a method of orienting a surgical tool in a total hip arthroplasty procedure comprising the steps of: providing a surgical system preferably according to a second aspect of the present invention; collecting patient specific pre-operative data; with the patient in a supine position, aligning the surgical tool with one or more anatomical landmarks of the patient and/or a patient support device, and obtaining calibration data for one or more said surgical-tool angular measurement devices of the surgical system; processing the calibration data and calibrating the or each angular measurement device of the surgical system; interoperatively collecting in real-time surgical tool orientation data using the angular measurement device, processing the surgical tool orientation data, and providing real-time surgical tool orientation indicia based on the surgical tool orientation data; and orienting the surgical tool with respect to the patient’s anatomy based on real-time surgical tool orientation indicia.
  • Collecting patient specific pre-operative data allows for a target angle of inclination and/or anteversion to be determined so enable optimal positioning of the acetabular cup.
  • Obtaining calibration data enables the inclination angle to be measured interoperatively with respect to the patient.
  • Providing and processing the surgical tool orientation data and providing surgical tool orientation data allows for the surgeon to be directed towards the optimal orientation of the surgical tool.
  • the patient specific pre-operative data may include an acetabular anteversion angle and/or an acetabular inclination angle. Both an anteversion and inclination angle allow for an implantation axis to be defined to allow the definition of the optimal acetabular positioning and/or orientation.
  • the patient specific pre-operative data may be transformed from one of an operative, radiographic or anatomical reference system to another of the operative, radiographic or anatomical reference systems.
  • Transforming the patient specific pre-operative data allows for a target anteversion and inclination angle to be determined and provided in a given reference system and then for the surgeon to be provided with direction and/or indicia in another reference system. This allows for the use of target angles or safety factors, which may be provided in medical literature, to be used regardless of whether the reference frame they are provided corresponds to the reference frame used during surgery of the patient.
  • the calibration data may at least in part be obtained by aligning at least part of the surgical system with the iliac spines of a pelvis of the patient.
  • the iliac spines provide an indication of the transverse direction of the patient and are easily found by interoperative palpation by the surgeon.
  • the surgical tool orientation indicia may be displayed on the electronic display device.
  • the surgical tool orientation indicia being displayed electronically allows for orientation indicia to be displayed in various formats such as numerical or graphical.
  • the surgical tool orientation indicia may include a range of surgical tool orientation data, corresponding to a safety zone.
  • the provision of a safety zone gives a range of acceptable implantation axes or orientations.
  • a method of orienting a surgical tool in a total hip arthroplasty procedure comprising the steps of: providing a surgical system preferably according to a second aspect of the present invention; collecting patient specific pre-operative data; with the patient in a lateral decubitis position, aligning the surgical tool with one or more anatomical landmarks of the patient and/or a patient support device, and obtaining calibration data for one or more said surgical-tool angular measurement devices of the surgical system; processing the calibration data and calibrating the or each angular measurement device of the surgical system; interoperatively collecting in real-time surgical tool orientation data using the angular measurement device, processing the surgical tool orientation data, and providing real-time surgical tool orientation indicia based on the surgical tool orientation data; and orienting the surgical tool with respect to the patient’s anatomy based on real-time surgical tool orientation indicia.
  • Figure 1 shows a perspective representation of a first embodiment of a surgical-tool angular measurement device, in accordance with the first aspect of the present invention
  • Figure 2 shows a side view of the surgical-tool angular measurement device of Figure 1 with an inertial measurement element removed for clarity;
  • Figure 3 shows a perspective representation of a first embodiment of the surgical system in accordance with the second aspect of the present invention in use being positioned at an acetabulum;
  • Figures 4a, 4b and 4c show indicative representations of the angles of inclination and anteversion in the Operative, Radiographic and Anatomic reference frames respectively.
  • Figure 5 shows a side view of a second embodiment of a surgical-tool angular measurement device, in accordance with the first aspect of the present invention, with the inertial measurement element removed for clarity;
  • Figure 6 shows a perspective representation of a lateral cross-section of a third embodiment of a surgical-tool angular measurement device, in accordance with the first aspect of the present invention, with the inertial measurement element removed for clarity;
  • Figure 7 shows a side view of a fourth embodiment of a surgical-tool angular measurement device, in accordance with the first aspect of the present invention, with the inertial measurement element removed for clarity;
  • Figure 8 shows a perspective view of a fifth embodiment of a surgical-tool angular measurement device, in accordance with the first aspect of the present invention, with the inertial measurement element removed for clarity;
  • Figure 9 shows a further perspective view of the surgical-tool angular measurement device of Figure 8, with the inertial measurement element removed for clarity
  • Figure 10 shows a front perspective view of sixth embodiment of a surgical -tool angular measurement device, in accordance with the first aspect of the present invention, with the inertial measurement element removed for clarity;
  • Figure 11 shows a longitudinal cross-section of the surgical-tool angular measurement device of Figure 9, in accordance with the first aspect of the present invention, with the inertial measurement element removed for clarity;
  • Figure 12 shows a top perspective representation of a seventh embodiment of a surgical-tool angular measurement device, in accordance with the first aspect of the present invention, with the inertial measurement element removed for clarity.
  • FIG. 1 and 2 there is shown a first embodiment of a surgical-tool angular measurement device 10 for removable attachment to a surgical tool 12 having a housing 14 and an inertial measurement element 16 having one or more inertial sensors and/or magnetometers.
  • the housing 14 includes a fastening means 18 for removable engagement with the surgical tool 12 and acceleration damping means 20 for damping undesirable linear and/or rotational acceleration imparted by said surgical tool 12.
  • the housing 14 preferably includes a tray 22 adapted to receive the inertial measurement element 16, the tray 22 having one or more sides and a base 24.
  • the base 24 is or is substantially rectangular in shape and each side projects at or adjacent to each edge of the base 24.
  • the sides are here contiguous with each other and there are two longitudinal sides 26 and two transverse sides 28, the longitudinal sides 26 being of greater length than the transverse sides 28.
  • Each side 26, 28 extends in a direction normal or substantially normal to an inertial-measurement-element engaging surface of the base 24.
  • Each side 26, 28 is a short upstanding wall which projects from the base.
  • Each longitudinal side 26, 28 preferably has an inertial -measurement-element access opening 30 through a transverse extent thereof. The inertial- measurement-element access opening 30 here extending to an upper or distal edge of the longitudinal side 26, 28.
  • the base may in fact be any other shape such as circular, elliptical or triangular.
  • the base whilst described as having four sides with a side projecting at or adjacent to each edge of the base, it is appreciated that there may be fewer or more than four sides or no sides at all, and that each side may be positioned away from the edge of the base or there may not be a side for each edge.
  • each longitudinal side is shown as having an inertial- measurement-element access opening, it is appreciated that there may not be an inertial-measurement- element access opening, there may be fewer than two, or they may be on one of the transverse sides.
  • the tray may have a covering, cap or lid for securing the angular measurement element within the tray.
  • the acceleration damping means 20 preferably extends from the base 24 of the tray 22 and may extend from an acceleration-damping-means engaging surface 32 of the base 24.
  • the acceleration-damping- means engaging surface 32 opposes an inertial-measurement-element engaging surface of the base 24.
  • the acceleration damping means 20 preferably includes a plurality of mounting members 34 which interconnect the tray 22 and the fastening means 18.
  • the mounting members 34 are discontinuously aligned with each other along a longitudinally extending centre-line of the base 24.
  • the mounting members 34 are therefore spaced apart from each other.
  • Each mounting member 34 preferably has at least one curvate surface and here each surface of each mounting member 34 which opposes another mounting member 34 is curvate. Although described as having curvate surfaces it is appreciated that each mounting member 34 may in fact not have a curvate surface.
  • the mounting members 34 may preferably extend in a lateral direction of the base 24 to a greater extent than in a longitudinal extent of the base 24.
  • the acceleration damping means 20 Whilst the acceleration damping means 20 is described as being a plurality of spaced apart mounting members 34, the acceleration damping means 20 may alternatively be considered to be a single mounting member 34.
  • the mounting member 34 would be strip shaped and aligned with a longitudinally extending centre-line of the base 24 having a plurality, and here five, apertures 36 extending through a transverse extent of the mounting member 34. Each aperture 36 may have curvate walls.
  • the fastening means 18 comprises a mount 38 and has a tubular or substantially tubular form, having a substantially cylindrical channel 40 or groove extending in an axial direction of the mount 38.
  • the mount 38 is elongate and extends in a direction parallel to the longitudinally extending centre-line of the base 24.
  • the mount 38 is positioned at or adjacent to the acceleration damping means 20 and/or base 24 and a longitudinally extending opening 42 extends in an axial direction, distal from the base 24 and/or the acceleration damping means 20.
  • a strip-shaped guiding member 44 extends outwardly at or adjacent to each edge of the opening 42. Each guiding member 44 extends at least in part away from each other and radially or substantially radially away from the channel 40.
  • the intersection between the guiding members 44 and the cylindrical channel of the mount 38 may be considered be a neck 46 of the mount 38.
  • the mount 38 may be considered to have a U-shaped, substantially U-shaped, horseshoe-shaped and/or substantially horseshoe-shaped profile or transverse cross-section.
  • the inertial measurement element 16 is positioned within the housing 14 and preferably received between the sides 26, 28 of the tray 22 engaging the mount 38.
  • the inertial sensors of the inertial measurement element 16 preferably include at least one accelerometer and/or at least one gyroscope. More preferably the inertial sensors make up a six-axes inertial measuring unit having a three-axes accelerometer, a three-axes gyroscope and a motion fusion processor or sensor fusion processor.
  • a motion fusion processor or sensor fusion processor combines or computes the measurements or readings from the accelerometer, gyroscope and/or magnetometer. This provides less uncertainty for the output of the inertial measurement element 16.
  • the inertial measurement element 16 provides indication of yaw, pitch and roll. Whilst the inertial sensors are described and shown as preferably having both accelerometers and gyroscopes, it will be appreciated that either accelerometers or gyroscopes may be used. For example, if the patient is in a supine position, the measurement of an anteversion angle could be achieved only by a three-axis accelerometer and the measurement of the inclination angle could be achieved with only a three-axis gyroscope. However, the use of both accelerometers and gyroscopes in combination improves measurement accuracy and precision and is therefore preferred.
  • At least part of the housing 14, including at least part of the tray 22, acceleration damping means 20 and or fastening means 18, may be formed from an elastomeric material such as silicone; polyether block amide, for example PEBA 2301; Nylon 12, for example PA 2200; or another flexible and/or pliable material.
  • elastomeric material such as silicone; polyether block amide, for example PEBA 2301; Nylon 12, for example PA 2200; or another flexible and/or pliable material.
  • a surgical system 48 for use in total hip arthroplasty the surgical system 48 firstly comprising a surgical tool 12 adapted to engage an implant at or adjacent to an acetabulum 50 of a patient.
  • the surgical tool 12 here has a head 52, for supporting an in use acetabular cup 54, a handle 56 and an elongate stem 58 interconnecting the handle 56 and the head 52.
  • the stem 58 here has a constant or a substantially constant lateral extent and may have a circular or substantially circular lateral cross-section. Whilst the surgical tool 12 is described as being for engaging an implant at or adjacent to the acetabulum 50, it will be appreciated that the surgical tool 12 may in fact be for reaming the acetabulum 50 and/or for other surgical activities concerning total hip arthroplasty or otherwise.
  • the surgical tool Whilst the surgical tool is described as having a handle, a stem and a head, it is appreciated that the surgical tool may in fact be a uniformly shaped member and not have distinct parts. Additionally, the stem may here not have a constant or circular lateral extent and may in fact have different shaped lateral extent, for example elliptical, rectangular or triangular. Any tool for use in total hip arthroplasty could be combined with the present arrangement.
  • the surgical system 48 further comprises a surgical -tool angular measurement device 10’ for removable attachment to the surgical tool 12.
  • the surgical -tool angular measurement device 10’ may be the same as, similar or different to the embodiment described previously.
  • the surgical-tool angular measurement device 10’ may be removably attached to the stem 58 of the surgical tool 12 via the fastening means 18 engaging with the stem 58.
  • the stem 58 may be received within and therefore extend through the axial extent of the channel 40 of the mount 38.
  • the stem 58 of the surgical tool 12 preferably has a greater diameter than an inner width of the neck 46 of the mount 38 and therefore there is a reduced chance of unintentional removal.
  • the surgical system 48 may preferably also comprise an electronic display device 60 communicatively connected to the surgical-tool angular measurement device 10’.
  • the electronic display device 60 may be part of a portable electronic device 62 separate and external to the surgical-tool angular measurement device 10’.
  • the portable electronic device 62 may have a data storage device and a processor.
  • the surgical-tool angular measurement device 10’ preferably has a data connection with the electronic display device 60.
  • the data connection may be wireless and so the surgical-tool angular measurement device 10’ may have a data emitter and the electronic display device 60 may have a data receiver. In this way, readings or measurements from the inertial measurement element 16 may be transmitted from the surgical-tool angular measurement device 10’ to the electronic display device 60 and there displayed.
  • the electronic display device may be attached to or positioned at or adjacent to the surgical-tool angular measurement device and/or may have a wired connection therebetween.
  • the surgical-tool angular measurement device 10’ is attached to the stem 58 of the surgical tool 12. This may be achieved by aligning a longitudinal extent of the stem 58 and the surgical-tool angular measurement device 10’.
  • the guiding members 44 are engaged with the stem 58 and the surgical-tool angular measurement device 10’ and the surgical tool 12 are forced, pushed or moved together.
  • the neck 46 of the mount 38 may be narrower than the diameter of the stem 58
  • the mount 38 may be required to deform so as to widen the neck 46 such that the stem 58 of the surgical tool 12 may pass through the neck 46 and into the curvate portion of the channel 40.
  • the mount 38 returns to its initial shape to form an interference or snap fit around the stem 58 and at least part of an inner circumferential extent of the mount 38 engages an outer circumferential extent of the stem 58 of the surgical tool 12.
  • vibrations, force and/or acceleration caused by the device and tool impacting each other.
  • These vibrations, forces and/or accelerations are typically reduced by comparison with those of a conventional attachment means of a surgical tool 12 and device which may be magnetic.
  • the vibrations, force and/or acceleration which do occur may travel from the mount 38 to the acceleration damping means 20, which interconnects the fastening means 18 and the tray 22.
  • the mounting members 34 damp the vibrations whereby the mounting members 34 are caused to extend, compress or otherwise deform by the aforementioned forces. This converts the vibrations, forces and/or accelerations into heat energy, thus dissipating any impact forces.
  • the mounting members may be considered to friction damp, hysteresis damp or extensionally damp the vibrations, force and/or acceleration.
  • the ability of the mounting members 34 to damp the vibrations by extending and compressing is enhanced by their spaced apart arrangement. Additionally, the aforementioned materials the acceleration damping means 20 may be formed from have a lower elastic modulus than typical engineering materials and therefore are more likely to extend, compress and convert energy. By reducing the vibrations, forces and/or accelerations through the surgical-tool angular measurement device 10’, the inertial measurement element 16 may not be affected by the vibrations, forces and/or accelerations. The inertial measurement element 16 may therefore provide more accurate and/or reliable readings or measurements.
  • the longitudinally spaced apart arrangement of the mounting members 34 here dampens vibrations, accelerations and/or forces which act through a longitudinal extent of the surgical-tool angular measurement device 10’ and or the surgical system 48.
  • each mounting member is able to deform in a longitudinal direction of the surgical -tool angular measurement device 10’ in the same axis, maximising the damping effect.
  • Each mounting member 34 extending in a lateral extent of the base more than a longitudinal extent allows each mounting member to deform more easily in a longitudinal direction than in a lateral direction. This thereby provides a greater proportion of longitudinal damping.
  • patient pre-operative data is collected which may take the form of determining an anteversion angle and an inclination angle of the acetabulum 50 of the patient.
  • the acetabular cup 54 When attaching the acetabular cup 54 to the acetabulum 50, the acetabular cup 54 should be aligned with a predetermined implantation axis I.
  • the implantation axis I can be defined by a target anteversion angle and a target inclination angle.
  • the implantation axis I, and target anteversion and/or the inclination angle is patient specific pre-operative data.
  • the anteversion and inclination angles can be defined in three different reference systems: the radiographic, operative and anatomical reference systems.
  • the radiographic reference system is used in X-Ray imaging procedures and also in surgery when the patient is supine.
  • the anteversion angle a is given by the angle between the implantation axis and a coronal plane C.
  • the inclination angle Q is given by the angle between the implantation axis G projected in the coronal plane C and a sagittal plane S.
  • the operative reference frame is used when in surgery and the patient is on their side in a lateral decubitis position.
  • the anteversion angle f is given by the angle between the coronal plane C the implantation axis I” is projected on the sagittal plane S.
  • the inclination angle d is given by the angle between the sagittal plane S and the implantation axis I.
  • the anatomical reference frame is when the patient is upstanding.
  • the anteversion angle g is given by the angle between the implantation axis G” projected on a transverse plane T and the coronal plane C.
  • the inclination angle b is the angle between the implantation axis I and a longitudinal axis F.
  • Determination of the inclination and anteversion angles of the implantation axis I may be made preoperatively through reconstruction of the patient’s anatomy to determine the likely range of motion of the femoral stem 58 relative to the acetabular cup 54. This may be achieved through X-Ray imaging, ultrasound scanning, magnetic resonance imaging and/or other imaging techniques.
  • the desired implantation axis I and associated inclination and anteversion angles typically in a radiographic reference frame given their determination through radiology, are recorded.
  • the recorded target inclination and anteversion angles may be transferred to the portable electronic device 62 and stored on the data storage device or stored directly on the surgical-tool angular measurement device 10’.
  • the incision is commonly made anterior to the hip.
  • the head portion of the femur and the acetabulum 50 are then exposed and the head of the femur is dislocated from the acetabulum 50.
  • the head of the femur is removed and a femoral head prosthetic may be attached to the remainder of the femur.
  • a reamer is required and it may be desirable to orient the reamer according to or with reference to the implantation axis I.
  • the aforementioned surgical tool 12 is a reamer and the reamer may be orientated with respect to the implantation axis I in a similar way as will be described subsequently for the implantation of the acetabular cup 54. Any vibrations, accelerations or forces caused by the reamer may be damped or dissipated by the acceleration damping means 20 so as to not to affect the readings provided by the inertial measurement element 16.
  • the acetabular cup 54 is attached to the head 52 of the surgical tool 12 and is required to be implanted at the previously determined implantation axis I.
  • the anteversion and inclination angles a, Q in the radiographic reference frame are required to be determined real-time during surgery.
  • the real-time anteversion and inclination angles a, Q may be considered to be real-time surgical tool 12 orientation data.
  • calibration data or a reference measurement is first required to be taken.
  • the calibration data is taken by aligning the surgical tool 12 with a transverse direction of the patient, indicated by anatomical landmarks such as the iliac spines of the patient or the transverse direction of the patient support device, for example a table.
  • the readings of yaw, pitch and roll of the inertial measurement element 16 when the surgical tool 12 is aligned in this way may be recorded so as to provide calibration data.
  • the recording may take the form of transferring the readings from the surgical- tool angular measurement device 10’ to the portable electronic device 62.
  • the data of the readings may be electronically stored on the surgical-tool angular measurement device 10’.
  • the recording and or transferal of calibration data may be initiated by the surgeon triggering a button, lever or other switch. In this way the surgical-tool angular measurement device 10’ is calibrated.
  • the inclination angle Q of the surgical tool 12 is then given by the difference in yaw between the position of the surgical tool 12 and the calibration data or reference measurement, subtracted from 90°.
  • the anteversion angle a of the surgical tool 12 is given by the reading of pitch provided by the inertial measurement element 16 on the surgical tool 12.
  • the coronal plane C can be approximated to be the horizontal plane, which may be defined as being as a plane perpendicular to the direction of gravity, which in turn is measurable by the accelerometer of the inertial measurement element 16. Therefore, the measurement of the anteversion angle does not require a reference and is given by the pitch reading of the inertial measurement element 16 with respect to the horizontal.
  • the real-time anteversion and inclination angles a, Q of the surgical tool 12 may thus be measured and the readings may be transferred from the inertial measurement element 16 to the electronic display device 60 where they are displayed in real-time.
  • the predetermined target inclination and anteversion angles a, Q are similarly displayed on the electronic display device 60 and the surgeon or other medical practitioner may attempt to match the real-time readings with the target angles.
  • This provides surgical tool 12 orientation indicia. This would align the surgical tool 12, and thus the acetabular cup 54, with the predetermined implantation axis I.
  • the predetermined target inclination and anteversion angles a, Q, the surgical tool 12 orientation indicia may be shown with a safety factor, for example plus or minus 10° to either or both angles.
  • the difference between the target inclination and anteversion angles and the real-time surgical tool 12 orientation data may be displayed graphically on the electronic display device 60 so as to result in graphical real-time surgical tool 12 orientation indicia.
  • the surgical-tool angular measurement device 10’, the electronic display device 60, or the portable electronic device 62 may have an audio emitter to emit audio feedback to guide the surgeon to the predetermined implantation axis I.
  • the acetabular cup 54 may then be implanted at the determined orientation and may be fixed in place with bone cement.
  • the femoral head prosthesis may then be inserted into the acetabular cup 54 and the incision closed.
  • the real-time anteversion and inclination angles f, d may be measured through a different method as the operative reference system is used.
  • the inclination angle d is given by the pitch as measured by the inertial measurement element 16 between the horizontal and the surgical tool 12, subtracted from 90°. This provides at least part of the real-time surgical tool 12 orientation data.
  • the anteversion angle f is provided by first taking calibration data.
  • Calibration data may be taken by aligning the surgical tool 12 with the longitudinal axis L of the patient and/or the patient support device, such as a table.
  • the anteversion angle f is then given from the difference in yaw between the calibration data and the orientation of the surgical tool 12.
  • the surgical tool 12 may thus be oriented in an operative reference frame in the same way as described in the radiographic reference frame.
  • the portable electronic device 62 and/or the surgical-tool angular measurement device 10’ may therefore have a processor and a data storage device for performing these calculations so as to enable interoperative calculation of the real-time surgical tool 12 orientation data and/or real-time surgical tool 12 orientation indicia.
  • Conversion and/or transformation of the relevant anteversion and/or inclination angles may be required if suggested anteversion and/or inclination angles are given in medical literature in different reference frames from which the surgeon may be using interoperatively. For example, if the surgeon desires to use a target angle with a given safety zone, such as plus or minus 10°, which may be quoted in medical literature in an anatomic reference frame. If the surgeon is carrying out a surgery with the patient on their side, this angle would be required to be transformed to an operative reference frame.
  • a target angle with a given safety zone such as plus or minus 10°
  • FIG. 5 and 6 there is shown a second embodiment of a surgical-tool angular measurement device 110 wherein the acceleration damping means 120 include a plurality of cylindrical or substantially cylindrical mounting members 134.
  • the acceleration damping means 120 include a plurality of cylindrical or substantially cylindrical mounting members 134.
  • Elements which are similar or identical to those of the preceding embodiments are denoted by the same or similar reference numbers with a prefix of‘ G and further detailed description is omitted.
  • the cylindrical mounting members 134 are preferably hollow and/or tubular along a longitudinal extent of the mounting member 134. However, it is appreciated that the mounting members 134 may be solid or at least in part solid and therefore not hollow.
  • the cylindrical mounting members 134 are spaced apart from one another in a longitudinal and/or transverse direction of the base 124 and project from the acceleration-damping-means engaging surface 132 of the base 124.
  • the mounting members 134 are thus arranged so that there is one mounting member 134 aligned with the longitudinally extending centre-line of the base 124 of the tray 122.
  • the said two mounting members 134 are aligned in a transverse direction of the base 124 and are transversely spaced apart from the longitudinally extending centre-line of the base 124. Whilst described as being in the above spatial arrangement, it is appreciated that the cylindrical mounting members 134 may arranged in a different arrangement, for example the mounting members 134 may be linearly aligned or uniformly distributed.
  • the second embodiment of a surgical-tool angular measurement device 110 is used as the first embodiment is described in use.
  • the hollow and spaced apart mounting members 134 may more easily deform than other arrangements and thereby damp lower energy vibrations and or provide a greater damping effect.
  • the mounting members 134 being symmetrical and spaced apart in a longitudinal and lateral extent of the base 124 enables the mounting members 134 to deform in either a longitudinal or lateral extent.
  • the fact that the mounting members 134 are hollow allows for them to more easily deform in a direction or substantially a direction from the fastening means 118 to the tray 122. This therefore provides a damping effect in this direction, which may be considered to be a vertical direction.
  • mounting members may in fact only be one of cylindrical and hollow.
  • FIG. 7 there is shown a third embodiment of a surgical-tool angular measurement device 210 wherein the mounting members 234 include at least one curvate blade.
  • the mounting members 234 include at least one curvate blade.
  • the curvate blades 234 are strip shaped or substantially strip shaped and are be spaced apart in a longitudinal direction of the base 224 of the tray 222.
  • the mounting member 234 are preferably uniformly spaced apart.
  • Each blade 234 here has a concave and a convex surface, with concave and convex surfaces of adjacent mounting members 234 opposing each other.
  • the mounting members 234 may therefore be considered to be arcuate or substantially arcuate. Whilst described as having both convex and concave surfaces, it is appreciated that each mounting member 234 may in fact only have a convex or a concave surface.
  • the third embodiment of a surgical -tool angular measurement device 210 is used as the first and second embodiment is described in use.
  • the mounting members 234 are curvately biased or oriented in a given direction, the mounting members 234 can more effectively damp accelerations and or vibrations in a longitudinal direction of the surgical-tool angular measurement device 210.
  • the mounting members 234 may be able to more easily deform in a direction substantially in a radially inward direction of the arcuate mounting member 234.
  • the arcuate nature of the mounting members 234 enables them to more easily deform in a direction or substantially a direction from the fastening means 218 to the tray 222. This therefore provides a damping effect in this direction, which may be considered to be a vertical direction.
  • the acceleration damping means 320 includes the tray 322, the tray 322 having an inner tray element 364 adapted to receive the inertial measurement element, and an outer tray element 366 attached to the inner tray element 364 and disposed therearound, the outer tray element 366 interposing the mount 338 and the inner tray element 364.
  • Elements which are similar or identical to those of the initial embodiments are denoted by the same or similar reference numbers with a prefix of ‘3’ and further detailed description is omitted.
  • Each of the inner and outer tray elements 364, 366 are preferably similarly formed as the tray 22 in the preceding embodiments, each having sides 326, 328, a base 324 and at least one inertial-measurement- element access opening 330.
  • the inner tray element 364 preferably has a smaller longitudinal and lateral extent than the outer tray element 366 with the inner tray element 364 being received within the outer tray element 366.
  • the inertial-measurement-element access openings 330 of the inner tray element 364 and the outer tray element 366 are preferably aligned to allow access therethrough.
  • the inner tray element 364 is preferably attached to the outer tray element 366 via at least one, and here a plurality of, inter-tray mounting members 368.
  • the inter-tray mounting members 368 interengage an inner surface of the outer tray element 366 and an outer surface of the inner tray element 364.
  • the inter-tray mounting members 368 are here spaced apart and interengage the comers and the lateral sides of the inner and outer tray elements 364, 366. However, it is appreciated that the inter-tray mounting members 368 may in fact interengage any part of either tray element 364, 366.
  • the base of the inner tray element may be suspended or supported above the base of the outer tray element.
  • the bases may interengage or form a single unitarily formed base.
  • the outer tray element 366 may be attached to the fastening means 318 or further acceleration damping means 320 and in this way interposes the mount 338 and the inner tray element 364.
  • the outer tray is described and shown as having the same form and/or shape as the inner tray and the tray in the preceding embodiments, it will be appreciated that the outer tray is not for directly holding the inertial measurement element. Therefore, the form of the outer tray is not required to correspond to the inertial measurement element and may therefore not have a substantially rectangular cross-section or profile.
  • the outer tray may in fact have any curvate or polygonal cross-section or profile.
  • the fourth embodiment of a surgical-tool angular measurement device 310 is used as the preceding embodiments is described in use.
  • the separation of the inner and outer tray elements 364, 366 reduces, limits or prevents acceleration, forces or vibrations from affecting the inner tray element 364 and therefore the inertial measurement element 16.
  • the outer tray element 366, the inner tray element 364 and/or the inter-tray mounting members 368 may provide damping through damping and thus may deform, extend and/or compress. Given that the inner tray 364 may be interposed and/or spaced apart from the outer tray 366 by inter-tray mounting members 368 in or in substantially a longitudinal, lateral and what may be considered to be vertical direction, damping may be provided in these directions.
  • FIG. 9 there is shown a fifth embodiment of the surgical-tool angular measurement device 410 wherein the mount 438 has a V-shaped or substantially V-shaped profile.
  • Elements which are similar or identical to those of the initial embodiments are denoted by the same or similar reference numbers with a prefix of‘4’ and further detailed description is omitted.
  • the mount 438 or fastening means 418, has two fastening members 470 which extend at right angles or substantially at right angles to each other. Whilst described as extending at or substantially at right angles, it is appreciated that the fastening members may extend at an angle to each other greater or less than 90°, for example between 80° and 100°.
  • Each fastening member 470 preferably has at least one magnetic element 472 and here each fastening member 470 has two magnetic elements 472, although any number of magnetic elements 472 may be included.
  • the magnetic elements 472 may be spaced apart from one another and are each be positioned at, adjacent to and/or spaced apart from a surgical-tool engaging surface 474 of the mount 438.
  • the magnetic elements 472 are insertable into each of the fastening members 470 of the V-shaped mount 438 through a surface opposing the surgical-tool engaging surface 474 of the mount 438.
  • the magnetic element 472 may have a drive to enable ease of insertion and removal. Although described in this arrangement it is appreciated that the magnetic elements 472 may not be insertable through the fastening members 470 and in fact each fastening member 470 may be a magnetic element 472. Additionally, each magnetic element 472 may be insertable through the surgical-tool engaging surface 474 of the mount 438.
  • the acceleration damping means 420 of the surgical-tool angular measurement device 410 preferably further includes a flexible blade 476.
  • the flexible blade 476 is arcuate or substantially arcuate in shape and may be positioned in an opening 478 within the housing 414, between the surgical-tool engaging surface 474 of the mount 438 and the remainder of the acceleration damping means 420 and/or the tray 422. It will be appreciated that the blade may be substantially planar and/or not positioned within the opening.
  • the flexible blade 476 is here elongate and aligned with a longitudinal extent of the surgical- tool angular measurement device 410. The flexible blade 476 may extend beyond the surgical-tool engaging surface 474 of the mount 438 so as to be directly engageable with the surgical tool 12.
  • the surgical-tool angular measurement device 410 may be fastened to the surgical tool 12.
  • the V-shaped mount 438 allows for the surgical-tool angular measurement device 10 to be attached directly to surgical tools 12 having stems 58 with angular or rectangular lateral cross-sections. Assuming that the surgical tool 12 is a magnetic element and/or is magnetic, the magnetic elements 472 of the mount 438 may magnetically attract with the surgical tool 12 so as to fasten the surgical -tool angular measurement device 410 to the surgical tool 12.
  • Fastening via magnetic elements 472 typically causes a high acceleration impact due to the increasing magnetic attractive force between the magnetic elements 472 as the distance between the magnetic elements 472 decreases.
  • the surgical tool 12 may engage the flexible blade 476.
  • the flexible blade 476 Upon engaging the flexible blade 476, the flexible blade 476 provides resistance to the engagement of the fastening members 470 and the surgical tool 12 and deforms. Therefore, the acceleration and/or speed of the movement of the surgical tool 12 and the surgical-tool angular measurement device 10 towards each other is reduced.
  • the deformation of the flexible blade 476 causes the dissipation and/or damping of the acceleration, forces, vibrations, and/or energy of the fastening of the surgical tool 12 and the surgical-tool angular measurement device 10. Therefore, the intensity and/or amount of vibrations and/or acceleration acting on the inertial measurement element 16 is reduced as compared to a conventional arrangement. Through damping, the flexible blade 476 may provide ongoing damping to acceleration, forces, vibrations, and/or energy resulting from the use of the surgical tool 12 during surgery.
  • FIG. 12 there is shown a sixth embodiment of the surgical-tool angular measurement device 510 wherein the mount 538 has a L-shaped or substantially L-shaped profile. Elements which are similar or identical to those of the initial embodiments are denoted by the same or similar reference numbers with a prefix of‘5’ and further detailed description is omitted.
  • the sixth embodiment has two fastening members 570.
  • the two fastening members 570 may again be at right angles to each other, although it is appreciated that they may extend at different angles to each other.
  • a first fastening member 580 may extend in a direction aligned with a longitudinally extending centre line and thus is here substantially coplanar with the base 524 of the tray 522.
  • a second fastening member 582 may extend in plane parallel with the sides 526, 528 of the tray 522.
  • Magnetic elements 572 may be positioned with respect to the sixth embodiment in the same or similar way as they are with respect to the fifth embodiment. Here the magnetic elements 572 are insertable through the surgical-tool engaging surface 574 of the mount 538.
  • the sixth embodiment may include a flexible blade in a similar or identical arrangement to that of the fifth embodiment.
  • the sixth embodiment may be used in a similar or identical way as preceding embodiments.
  • the surgical-tool angular measurement device has an inertial measurement element to allow desirable orientation of the surgical tool with respect to a patient and more specifically a patient’s acetabulum.
  • Fastening means enables the surgical-tool angular measurement device to be attached to the surgical tool and acceleration damping means interconnecting the surgical tool and angular measurement device prevent or limit the angular measurement device from being adversely affected by vibrations and/or accelerations.

Abstract

L'invention concerne un dispositif de mesure angulaire d'outil chirurgical (10 ; 110 ; 210 ; 310 ; 410 ; 510) destiné à être fixé de manière amovible à un outil chirurgical (12), le dispositif comprenant un boîtier (14), et un élément de mesure inertielle (16) ayant un ou plusieurs capteurs inertiels et/ou magnétomètres, le boîtier (14) comprenant des moyens de fixation (18) pour une mise en prise amovible avec un outil chirurgical (12), des moyens d'amortissement d'accélération (20) pour amortir une accélération non souhaitée et/ou rotative conférée par ledit outil chirurgical (12).
PCT/GB2019/051095 2018-04-20 2019-04-17 Dispositif de mesure angulaire d'outil chirurgical WO2019202320A1 (fr)

Applications Claiming Priority (2)

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GB1806491.5A GB2573014A (en) 2018-04-20 2018-04-20 Surgical-tool angular measurement device
GB1806491.5 2018-04-20

Publications (1)

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WO2019202320A1 true WO2019202320A1 (fr) 2019-10-24

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WO (1) WO2019202320A1 (fr)

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