WO2024110337A1 - Système d'assistance au chirurgien lors de la réalisation d'une coupe dans un os d'un patient - Google Patents
Système d'assistance au chirurgien lors de la réalisation d'une coupe dans un os d'un patient Download PDFInfo
- Publication number
- WO2024110337A1 WO2024110337A1 PCT/EP2023/082231 EP2023082231W WO2024110337A1 WO 2024110337 A1 WO2024110337 A1 WO 2024110337A1 EP 2023082231 W EP2023082231 W EP 2023082231W WO 2024110337 A1 WO2024110337 A1 WO 2024110337A1
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- WO
- WIPO (PCT)
- Prior art keywords
- bone
- saw
- cut
- sensor
- difference
- 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.)
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Classifications
-
- 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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/14—Surgical saws
- A61B17/142—Surgical saws with reciprocating saw blades, e.g. with cutting edges at the distal end of the saw blades
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/14—Surgical saws
- A61B17/15—Guides therefor
- A61B17/154—Guides therefor for preparing bone for knee prosthesis
- A61B17/157—Cutting tibia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00017—Electrical control of surgical instruments
- A61B2017/00115—Electrical control of surgical instruments with audible or visual output
- A61B2017/00128—Electrical control of surgical instruments with audible or visual output related to intensity or progress of surgical action
-
- 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
- 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
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3937—Visible markers
-
- 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
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/10—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis
- A61B90/11—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints
- A61B90/13—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges for stereotaxic surgery, e.g. frame-based stereotaxis with guides for needles or instruments, e.g. arcuate slides or ball joints guided by light, e.g. laser pointers
Definitions
- the present invention relates to a system for assisting a surgeon during the performance of a bone surgery, such as an arthroplasty surgery.
- a system which is suitable for guidance of the performance of a cut during the preparation of the bone when performing such a surgery, e.g. as part of a uni-compartmental knee arthroplasty.
- Partial knee replacement is a well-documented and increasingly used treatment for patients with knee osteoarthritis. Close to 2 million knee replacements are performed annually in OECD countries, and UKA surgery constitutes a growing proportion of these knee replacements.
- periprosthetic fracture A fracture related to the prosthesis (periprosthetic fracture) after UKA surgery can be an extremely severe complication. While they rarely occur (estimated 0.4% of UKAs), periprosthetic fractures have a major impact on the outcome for the patients. More invasive revision surgery is needed, resulting in an increased risk of infections and worse knee function.
- a first sensor configured to:
- a second sensor configured to: • be arranged on an associated bone-saw to be used for performing the cut,
- - - a receiver configured to:
- the system will be described with respect to the performance of a sagittal cut, since that is the use for which it was developed. However, it can also be used for cuts in other orientation.
- the sagittal plane or longitudinal plane, is an imaginary anatomical plane which divides the body into right and left parts. The plane may be in the centre of the body and split it into two halves (mid- sagittal) or away from the midline and split it into unequal parts (para-sagittal).
- sagittal cut is meant a cut in a sagittal plane so that if a patient is standing, a "sagittal cut” will be a vertical cut.
- the system has been developed for use during uni-compartmental knee arthroplasty, but it may be used in any type of cuts where it is important to keep a desired cutting angle. It is particularly advantageous for performing cuts where the surgeon performing the cut has limited or no direct view to the blade of the bone-saw at least during a part of the cutting process.
- a cutting guide is a small plate, typically made from metal, configured to be temporarily fixed to the bone by use of pins or screws. With this commonly accepted technique, the cutting guide remains with a stable fixation to the bone, in the desired position as described in the operative technique, throughout the bone cutting procedure.
- a cutting guide is typically arranged so that the upper surface constitutes a plane which is perpendicular to the cut to be made. Thus, when the bone-saw is kept so that the cutting edge of the blade extends in a direction parallel to the upper surface of the cutting guide, the cut will not continue further into the bone than intended.
- the feature that the first sensor is configured to be arranged on an associated cutting guide also includes embodiments in which the first sensor is built-into the cutting guide.
- bone-saw is to be understood as any tool that is suitable for the performance of a cut in a bone during a surgery.
- the measured spatial orientations of the cutting guide and of the blade of the bone-saw are the actual measures at the time of the measurement.
- the sampling rate of the first and second sensors should therefore be high enough to ensure that any changes of the spatial orientations are captured fast enough to prevent any accidental cuts outside of the desired cutting orientation provided that the surgeon reacts immediately to any changes of the indication presented on the at least one angle conformity indicator.
- the term "measure” used here and in the following in relation to the first and second sensors could also be referred to as “detect” or “detect and measure”.
- spatial orientation means a three- dimensional representation of the roll and pitch of the sensors compared to a given fixed orientation which is typically with the mounting surface of the sensor horizontal and with a height of the sensor aligned with the direction of gravity. However, for other desired cutting orientations, this may vary correspondingly.
- the use of a system according to the invention is expected to lower the risk of bone fracture caused by excessive angling during the performance of a cut during knee surgery. Such a fracture has a large impact on the patients experiencing it. Furthermore, a lowering of the risk of making an error will improve the working conditions for the surgeon, since such risk can cause an unpleasant pressure even on experienced surgeons.
- At least one of the first and second sensors may comprise a gyroscope.
- first and second sensors may comprise an accelerometer.
- both the first and the second sensors comprise both a gyroscope and an accelerometer.
- the gyroscope measures the orientation based gravity
- the accelerometer measures the orientation based on acceleration/vibration. They therefore complement each other and at least for some sensors result in a higher precision in the calculation of the angle than if only one type of sensor was used.
- Such types of sensors are already on the market and ready for use in the system. It is therefore expected that the cost of a system according to the invention will be relatively low compared to the cost of just one knee surgery.
- At least one of the first and second sensors is configured to be encoded, such as to be encoded in dependence of an actual application.
- the same sensors could be used in multiple types of surgery, by encoding the reference angles and any needed offsets to align the bone-saw with an optimal reference angle for a specific cut to be made.
- the first and/or the second output signals may be wirelessly transmitted to the receiver. This will make the handling of the system easier both during the placement of the cutting guide and the sensor thereon and during the performance of the cut. This is e.g. because the mutual arrangement of the sensors and the receiver is not limited by otherwise possible cables and because this removes the risk of damaging a cable. Furthermore, it is advantageous when the sensors are to be used in a sterile operating theatre where cables across the surgical field could cause contamination.
- the first and/or second signals may e.g. be radiofrequency signal(s) or Bluetooth signal(s).
- the second sensor is configured to be integrated in the bone-saw. It may e.g. be a permanent integration, possibly made during the manufacturing of the bone-saw, or it may be a replaceable arrangement. It may e.g. be possible to use different second sensors in a given bone-saw, so that the second sensor can be selected for a given application.
- the second sensor is to be mounted on an outer surface of the bone-saw without being integrated therewith. Such mounting could be by any suitable means such as by a screw-connection or by mutually engaging hatches.
- the receiver may be configured to be adjusted with respect to how the indication of the difference should be presented, such as dependent on which type of angle conformity indicator it is to be presented on. It may e.g. be possible to change between different types of indication dependent on a surgeon's preference.
- the angle conformity indicator may comprise one or more of the following: a display showing a numerical value, at least one light indicator of variable colour, a plurality of light indicators that can be individually lit, and a loudspeaker.
- a display showing a numerical value
- at least one light indicator of variable colour e.g., a plurality of light indicators that can be individually lit
- a loudspeaker e.g., a loudspeaker
- the first and second sensors are arranged and configured to measure the spatial orientations of the cutting guide and the blade of the bone-saw, respectively, in a saggital plane of the bone.
- system may further comprise:
- a third sensor configured to:
- a fourth sensor configured to:
- axial plane is preferably meant a plane perpendicular to the sagittal plane. When the sagittal plane is vertical, the axial plane will be horizontal.
- the third sensor is further configured to emit a laser beam for:
- the anatomic landmark to use will typically be the anterioir superior iliac spine of the ipsilateral hip and the laser beam of the third sensor will be pointed towards the medial side of the patella.
- An example of such a system and the use thereof will be shown in the figures.
- the receiver may be configured to send a switch-off signal to the bone-saw when the determined difference exceeds a predefined threshold value.
- a larger safety can be built into the system, since the bone-saw can be stopped automatically even if the surgeon does not react as intended in response to the provided indication.
- system further comprises:
- the system is designed so that is is configured to be mounted on an already existing cutting guide and bone-saw.
- This cutting guide and/or bone-saw may be delivered by the same supplier as the one supplying a system according to the presetn invention, or it may be another supplier.
- the invention in a second aspect, relates to a method of assisting a surgeon during the performance of a cut in a bone by use of a system according to the first aspect of the invention, the method comprising the following steps: - placing a cutting guide on the bone in which the cut is to be made,
- the step of arranging the second sensor on the bone-saw may be performed at a previous time than the other method steps. It will e.g. be possible to keep the second sensor on the bone-saw for longer periods of time instead of having to rearrange it there before each use.
- the first sensor may be permanently built into the cutting guide so that the step of arranging the first sensor on the cutting guide is performed at a previous time.
- the method may further comprise the following steps:
- the correct arrangement of the third sensor during preparation of the cut is typically obtained by placing the third sensor on the anatomic landmark , and
- the bone-saw is manually handled. This is the use for which the invention was developed, since this is the use where the risk of performing a cut at a wrong angle is highly dependent on the skills of the surgeon.
- the cutting guide and/or the bonesaw is integrated in a robot.
- Figure 1 schematically shows the bones of a knee and a bone-saw for performing a cut in the knee; the figure shows a sagittal cut.
- Figure l.a shows the intended angle of the bone-saw and figure l.b exaggerated shows a wrong cutting angle that will result in too deep a cut.
- FIG. 2 schematically shows an embodiment of the invention.
- Figure 3 schematically shows first and second sensors each provided with a gyroscope and an accelerometer.
- Figure 4 is a flow-chart of a method according to the invention.
- Figure 5 schematically shows an embodiment comprising third and fourth sensors.
- Figure 6 schematically shows another embodiment of the invention which is an alternative to the one in figure 5.
- Figure 1 schematically illustrates how it can cause problems when a bone-saw 1 is not held at the correct angle during the performance of a sagittal cut in a bone 2 of a patient.
- the bone 2 is a knee, since the invention has been developed based on a need for improvement in relation to unicompartmental knee arthroplasty.
- the system can also be used for other types of surgery where a cutting guide is used, and where assistance of the cutting angle is of advantage.
- Figure l.a shows a bone 2 on which a cutting guide
- Figure 2 schematically shows a system according to the invention when ready for use for the performance of a sagittal cut.
- the system would work in the same manner for cuts being performed in other orientations, such as a horizontal cut.
- a first sensor 8 is arranged on the cutting guide 3 which is placed on the bone 2 in which the sagittal cut is to be made. As explained in relation to figure 1, the cutting guide 3 defines a desired cutting orientation and cutting depth.
- a second sensor 9 is arranged on an outer surface of the bone-saw 1 to be used for performing the sagittal cut. As mentioned above, the second sensor 9 may alternatively be configured to be integrated in the bone-saw 1.
- the system has been developed for surgeries in which the bone-saw 1 is manually handled. However, the scope of protection also covers systems in which the cutting guide 3 and/or the bone-saw 1 is integrated in a robot (not shown).
- the first sensor 8 is configured to measure the spatial orientation of the cutting guide 3 and transmit a first output signal 10 representative of the spatial orientation of the cutting guide 3; this is shown in figure 3.
- the second sensor 9 is configured to measure the spatial orientation of the blade 5 of the bone-saw 1 and transmit a second output signal 11 representative of the spatial orientation of the bone-saw 1.
- the first and second sensors 8,9 may be configured to be encoded in dependence of an actual application.
- the system further comprises a receiver 12 which is configured to receive the first and second output signals 10,11 transmitted by the first and second sensors 8,9, respectively.
- the receiver 12 determines a difference between the spatial orientations of the blade 5 and the cutting guide 3 and thereby a difference between an actual cutting orientation and the desired cutting orientation; this difference is shown as 3 in figure 2.
- the receiver 12 presents an indication of the difference to the surgeon on at least one angle conformity indicator 13.
- the receiver 12 is shown as comprising the angle conformity indicator 13, but it may also be separate units.
- the angle conformity indicator 13 is a plurality of light indicators 14 that can be individually lit.
- the light indicators 14 preferably have different colours e.g. so that the middle light indicator is green and indicate that the bone-saw 1 is held at the correct angle, the two neighbouring light indicators are yellow, and the outermost light indicators are red.
- angle conformity indicators 13 may e.g. be a display showing a numerical value, at least one light indicator of variable colour, or a loudspeaker. More than one type may be used in combination, or it may be possible to switch between different types, e.g. based on the surgeon's personal preference.
- the receiver 12 may be configured to send a switch-off signal to the bone-saw 1 when the determined difference 3 exceeds a predefined threshold value. Hereby the risk of cutting errors can be lowered even further.
- At least one of the first and second sensors 8,9 comprises a gyroscope 15, and at least one of the first and second sensors 8,9 comprises an accelerometer 16.
- Figure 3 schematically shows an embodiment in which both sensors 8,9 comprise both a gyroscope 15 and an accelerometer 16.
- the first and second output signals 10,11 are wirelessly transmitted to the receiver 12, e.g. as radiofrequency or Bluetooth signals.
- Figure 4 is a flow-chart of a method according to the second aspect of the invention. The method comprises the following steps:
- A Placing a cutting guide 3 on the bone 2 in which the cut is to be made.
- step B may be performed at a previous time than the other method steps. It will e.g. be possible to keep the second sensor 9 on the bonesaw 1 for longer periods instead of having to re-arrange it there before each use. Steps D and E will in practise be performed simultaneously.
- FIG. 5 schematically shows an embodiment comprising third and fourth sensors 17,18.
- the figure shows the system when set-up and ready for use.
- the third sensor 17 is shown as being arranged on an anatomic landmark 21 related to the bone 2.
- the third sensor 17 is configured to measure the spatial orientation of the desired cut in an axial plane of the bone 2, and to transmit a third output signal 19 representative of the spatial orientation of the desired cut in the axial plane.
- a fourth sensor 18 is arranged on the bone-saw 1.
- the receiver 12 It is configured to measure the spatial orientation of the blade 5 of the bone-saw 1 in the axial plane of the bone 2, and to transmit a fourth output signal 20 representative of the spatial orientation of the blade of the bone-saw in the axial plane.
- the receiver 12 resembles the one shown in figure 2 and the description will therefore not be repeated. It is further configured to receive the third and fourth output signals 19,20 transmitted by the third and fourth sensors 17,18. Based on the received third and fourth output signals 19,20, the receiver 12 can determine a difference y between the spatial orientations of the blade 5 and the desired orientation of the cut in the axial plane and present an indication of this difference y to the surgeon on the angle conformity indicator in the same manner as described above in relation to the first and second sensors (8,9) and their functioning. There may e.g. two rows of LEDs arranged perpendicular to each other in order to visually represent the two angles.
- the third sensor 17 is further configured to emit a laser beam 22.
- the illustrated system is shows as being used in relation to a knee replacement, and the anatomic landmark 21 is the anterioir superior iliac spine of the ipsilateral hip.
- the laser beam 22 of the third sensor 17 will be pointed towards the medial side of the patella. Thereby it can be used for guiding the cutting process by visually indicating the desired orientation of the cut in the axial plane.
- Figure 6 schematically shows another embodiment of the invention which is an alternative to the one in figure 5.
- the desired orientation of the cut in the axial plane is ensured by the arrangement of a laser 23 on the bone-saw 1.
- the laser 23 emits a laser beam 22 towards a guiding plate 24 located at the anatomic landmark 21.
- the laser beam 23 hits the central region of the guiding plate 24 as shown in the figure.
- the guiding plate 24 may be provided with a laser sensor (not shown) configured to register when it is being hit by the laser beam 22.
- the laser sensor can then send a signal to the angle conformity indicator e.g. in the same way as described above for the other sensors.
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- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Medical Informatics (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
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Abstract
L'invention concerne un système d'assistance au chirurgien lors de la réalisation d'une coupe, telle qu'une coupe sagittale, dans un os (2) d'un patient. Il comprend un premier capteur (8) destiné à être disposé sur un guide de coupe associé (3) placé sur l'os (2), le guide de coupe définissant une orientation de coupe souhaitée. Il comprend également un second capteur (9) destiné à être disposé sur une scie à os (1) associée. Les premier et second capteurs mesurent l'orientation spatiale du guide de coupe et une lame (5) de la scie à os, respectivement, et transmettent des signaux de sortie (10, 11) représentatifs des orientations spatiales à un récepteur (12). Sur la base des premier et second signaux de sortie reçus, le récepteur détermine une différence (β) entre les orientations spatiales de la lame et du guide de coupe et présente une indication de la différence au chirurgien sur au moins un indicateur de conformité d'angle (13).
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP22208743.9A EP4374798A1 (fr) | 2022-11-22 | 2022-11-22 | Système d'assistance d'un chirurgien pendant la réalisation d'une découpe dans un os d'un patient |
| EP22208743.9 | 2022-11-22 | ||
| EP23165040.9 | 2023-03-29 | ||
| EP23165040 | 2023-03-29 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2024110337A1 true WO2024110337A1 (fr) | 2024-05-30 |
Family
ID=88863453
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2023/082231 Ceased WO2024110337A1 (fr) | 2022-11-22 | 2023-11-17 | Système d'assistance au chirurgien lors de la réalisation d'une coupe dans un os d'un patient |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2024110337A1 (fr) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE202011052439U1 (de) * | 2011-12-22 | 2012-01-31 | Aesculap Ag | Chirurgische Sägelehre, chirurgisches Sägeblatt und chirurgisches Sägesystem |
| US20140107471A1 (en) * | 2011-06-27 | 2014-04-17 | Hani Haider | On-board tool tracking system and methods of computer assisted surgery |
| US20200323540A1 (en) * | 2019-04-12 | 2020-10-15 | Mako Surgical Corp. | Robotic Systems And Methods For Manipulating A Cutting Guide For A Surgical Instrument |
| US20210369349A1 (en) * | 2006-06-16 | 2021-12-02 | Board Of Regents Of The University Of Nebraska | Method and apparatus for computer aided surgery |
-
2023
- 2023-11-17 WO PCT/EP2023/082231 patent/WO2024110337A1/fr not_active Ceased
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20210369349A1 (en) * | 2006-06-16 | 2021-12-02 | Board Of Regents Of The University Of Nebraska | Method and apparatus for computer aided surgery |
| US20140107471A1 (en) * | 2011-06-27 | 2014-04-17 | Hani Haider | On-board tool tracking system and methods of computer assisted surgery |
| DE202011052439U1 (de) * | 2011-12-22 | 2012-01-31 | Aesculap Ag | Chirurgische Sägelehre, chirurgisches Sägeblatt und chirurgisches Sägesystem |
| US20200323540A1 (en) * | 2019-04-12 | 2020-10-15 | Mako Surgical Corp. | Robotic Systems And Methods For Manipulating A Cutting Guide For A Surgical Instrument |
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