Tracker for surgical instrument

Abstract

An optical tracker usable with a handheld surgical instrument, the optical tracker comprising: a tracker frame comprising a mounting body, the tracker frame defining an instrument engagement aperture having a longitudinal axis; and a biasing body extending proximally from the mounting body. The instrument engagement aperture is configured to receive a proximal region of a surgical instrument such that a longitudinal axis of the tracker is aligned with an axis of the surgical instrument. Three radial segments of equal proportion are defined about the longitudinal axis and collectively surround the longitudinal axis. The tracker also includes at least six markers arranged to form at least two arrays coupled to the tracker frame and positioned such that at least one marker is positioned within each radial section. A portion of each array is coupled to the biasing body and positioned proximal to the mounting body.

Description

[0001] This application is a divisional application of Chinese patent application No. 202080077613.9, filed on September 28, 2020, entitled “Tracker for Surgical Instruments”. Background Technology

[0002] During surgery, surgeons frequently use instruments that must be inserted into the patient's body. Once inside, the surgeon cannot see the end of the instrument. In such cases, to assist the surgeon in navigating the instrument, a surgical navigation system can be used to track it and provide visual or auditory guidance.

[0003] One method for tracking the device is to attach a tracker to it. A camera in the operating room senses the tracker and generates data to calculate the tracker's position and, consequently, the device's position. Typically, the patient is also tracked, which allows the device's position relative to the patient to be calculated.

[0004] Further improvements to the tracker are needed. Attached Figure Description

[0005] The advantages of this disclosure will be readily understood when considered in conjunction with the accompanying drawings, as these advantages can be better understood by referring to the following detailed description.

[0006] Figure 1 This is an exemplary surgical kit illustrating a surgical navigation system.

[0007] Figure 2 This is an environmental view of a first embodiment of the tracker and the surgical instruments held by the user.

[0008] Figure 3 yes Figure 2 A perspective view of a tracker having a tracker frame attached to a surgical instrument and three radial segments arranged around the longitudinal axis of the tracker.

[0009] Figure 4 yes Figure 2 Another perspective view of the tracker, in which the tracker frame is shown as being attached to a surgical instrument.

[0010] Figure 5 yes Figure 2 The side view of the tracker shows the tetrahedral shape of the tracker frame and the two lines of sight between the tracker and the surgical instruments.

[0011] Figure 6 yes Figure 2 A top view of the tracker and surgical instruments, showing the marker array and areas.

[0012] Figure 7 yes Figure 2 The proximal view of the tracker and surgical instruments shows the emission patterns of three radial segments, a first region and a second region, and several markers.

[0013] Figure 8 yes Figure 2 A perspective view of the tracker, showing the tetrahedral shape of the tracker frame as well as the marker array and regions.

[0014] Figure 9 yes Figure 2 A perspective view of the tracker, showing the instrument engagement hole and the relief area.

[0015] Figure 10 yes Figure 2 The distal perspective view of the tracker shows the instrument engagement hole and retaining assembly.

[0016] Figure 11 yes Figure 2 An exploded view of the tracker, showing the interior of the tracker frame and the marker array.

[0017] Figure 12 This is a perspective view showing another embodiment of a tracker attached to a surgical instrument.

[0018] Figure 13 yes Figure 12 Another perspective of the tracker.

[0019] Figure 14 yes Figure 12 A side view of the tracker.

[0020] Figure 15 yes Figure 12 A top view of the tracker.

[0021] Figure 16 yes Figure 12 A close-up view of the tracker.

[0022] Figure 17 This is a perspective view showing yet another embodiment of a tracker attached to a surgical instrument.

[0023] Figure 18 yes Figure 17 Another perspective of the tracker.

[0024] Figure 19 yes Figure 17 A side view of the tracker.

[0025] Figure 20 yes Figure 17 A top view of the tracker.

[0026] Figure 21 yes Figure 17 A close-up view of the tracker.

[0027] Figure 22 This is a perspective view of another embodiment of the tracker.

[0028] Figure 23 yes Figure 22 A perspective view of the tracker.

[0029] Figure 24 yes Figure 22 A close-up view of the tracker.

[0030] Figure 25 It is connected to the surgical instruments. Figure 22 A side view of the tracker.

[0031] Figure 26 This is a perspective view of the tracker and surgical navigation cart. Detailed Implementation

[0032] Referring to the accompanying drawings, in which the same numerals denote the same components in several views, this disclosure includes a tracker 100 for a handheld surgical instrument 34, a surgical navigation system 12, and a method for operating the tracker 100. Figure 1 An exemplary surgical system 10 is shown, which may include a surgical navigation system 12 for tracking one or more surgical instrument assemblies 30, the surgical instrument assemblies 30 including surgical instruments 34 and trackers 100, to assist medical professionals (such as surgeons) in performing medical procedures.

[0033] The surgical navigation system 12 may include a navigation interface comprising one or more display units 14 and one or more user input terminals 16. The display units 14 of the surgical navigation system 12 may be configured to display various prompts or data input boxes. For example, the display unit 14 may be configured to display text boxes or prompts that allow the surgeon to manually input or select the type of surgical procedure to be performed. The display unit 14 may also be configured to display patient data, such as preoperative images or scans. As described above, preoperative images may be MRI scans, radiographic scans, or computed tomography (CT) scans based on the patient's anatomy. Preoperative images may be uploaded to the surgical navigation system 12 and displayed on the display unit 14. The display unit 14 may be further configured to display a surgical plan of a medical procedure overlaid on the patient data or images. The surgical plan may include a surgical path for performing the medical procedure or a planned trajectory or orientation of a medical device during the medical procedure. The surgical plan may also include overlaying the location and / or orientation of an implant or medical device to be inserted during the medical procedure onto the patient data or images. It is envisioned that the surgical navigation system 12 may include a display unit 14 configured to display and / or project a holographic image of a surgical path for performing a medical procedure or a planned trajectory or orientation of a medical device during the procedure. This may include projecting the surgical path onto a patient or other surface in the operating room. It may also include projecting the surgical path onto a head unit (e.g., lenses, shields, or glasses) worn by the surgeon. An exemplary configuration of the surgical navigation system 12 including a display unit worn by the surgeon to display a target trajectory and / or target location is disclosed in International Patent Application No. PCT / IB2018 / 053130, the entire contents of which are incorporated herein by reference.

[0034] User input terminal 16 can be configured to allow surgeons to input or type patient data or modify surgical plans. Patient data may include patient images, such as preoperative images of the patient's anatomy. These images may be based on MRI, radiographic, or computed tomography (CT) scans of the patient's anatomy. Patient data may also include additional information relating to the type of medical procedure being performed, the patient's anatomical features, the patient's specific medical condition, and / or operational settings used for surgical navigation. For example, during spinal surgery, the surgeon may input information via user input terminal 16 relating to the specific vertebra on which the procedure is being performed. The surgeon may also input various anatomical dimensions relating to the size and shape of the vertebra and / or medical devices or implants to be inserted during the procedure. User input terminal 16 may also be configured to allow surgeons to select, edit, or manipulate patient data. For example, the surgeon may identify and / or select anatomical features from the patient data. This may include selecting a surgical site, such as selecting a vertebra and / or a specific area on the vertebra on which the procedure is to be performed.

[0035] The surgical navigation system 12 may also include a navigation processor 18. The navigation processor 18 may be located on a personal computer or laptop computer. The navigation processor 18 may communicate with a user input terminal 16, a display unit 14, a central processing unit (CPU) and / or other processors, memory (not shown), and storage (not shown). The navigation processor 18 may also include software and / or operating instructions related to the operation of the surgical navigation system 12 and to implementing the various routines and / or methods disclosed herein. The software and / or operating instructions may include a planning system configured to find the precise position and / or angular alignment of the surgical instrument 34 relative to the patient 20. The navigation processor 18 may communicate directly or indirectly with the surgical instrument assembly 30 via wired or wireless communication.

[0036] The surgical navigation system 12 may also include a tracking unit 22 or a locator, which includes one or more sensors 24. Sensors may include cameras, such as CCD cameras, CMOS cameras and / or optical imaging cameras, magnetic sensors, radio frequency sensors, or any other sensors suitable for detecting and / or sensing the position of the tracking device 100 of the surgical instrument assembly 30. The locator 22 is capable of detecting radiation or light from the plurality of markers 128 and is capable of generating a locator signal representing the detected radiation or light. The exemplary surgical navigation system 12 may be configured to use a tracker 100 having a fixed spatial relationship between the markers 128. A description of the various suitable locators that may be used can be found in U.S. Patent No. 10,531,926 B2, which is incorporated herein by reference in its entirety.

[0037] Processor 18 may be able to receive locator signals. Processor 18 may also be able to register and track the tracker 100 based on the received sensor signals. Based on the locator signals, the processor may also be able to calculate the orientation and / or position of the tracker 100 relative to the locator 22. Processor 18 may have access to information about spatial relationships. In this case, a three-dimensional image captured by a stereo camera would not be required, and the camera may consist of only a single two-dimensional image sensor.

[0038] Processor 18 may also be configured to receive and / or store information about the patient's body 20 (e.g., computed tomography scans and / or tracking signals of the patient's body). Processor 18 may then calculate the position and / or orientation of surgical instrument 34 relative to the patient's body 20. Processor 18 may be configured to generate visual or auditory signals instructing the tracking of surgical instrument 34. Visual signals may be displayed on a display unit. Processor 18 may be part of a computing device separate from the locator. Alternatively, the locator may include a processor.

[0039] Figure 2A perspective view of a first configuration of the tracker 100 and surgical instrument 34 is shown. The surgical instrument 34 has a proximal end 36 and a distal end 38 spaced apart along an instrument axis 40. In, for example... Figure 2 In many of the cases shown, the surgical instrument 34 transmits mechanical energy along the instrument axis 40 from a source (e.g., a motor or ultrasonic transducer) located near the proximal end 36 to an attachment 42 coupled to the distal end 38 of the surgical instrument 34. An example of this arrangement is shown in... Figures 2-7 As shown, surgical instrument 34 is illustrated as a high-speed drill. Here, surgical instrument 34 may include a housing 46, a motor (not shown) disposed within the housing 46, a flexible power cable 48 extending from the housing 46 in the proximal region, and an attachment interface 50 located near the distal end 38 of surgical instrument 34. Exemplary surgical instruments can be found in U.S. Patent No. 8,597,316 and U.S. Patent Publication No. 2017 / 0319217, which are incorporated herein by reference in their entirety.

[0040] Tracker 100 can operate in conjunction with surgical instruments 34 and a surgical navigation system to determine the position and / or orientation of surgical instruments 34 within the operating room. To accurately determine the position of surgical instruments 34, tracker 100 is coupled to surgical instruments 34 and configured to prevent relative movement between them during surgery. Furthermore, tracker 100 should be coupled to surgical instruments 34 to maximize the visibility of tracker 100 via the surgical navigation system.

[0041] Although surgical instrument 34 is shown as a high-speed drill in all figures, tracker 100 can be used with surgical instrument 34 other than a high-speed drill. For example, tracker 100 can be attached to a handheld ultrasonic ablation tool or biopsy needle or part of a robotic device (e.g., a robotic end effector). Similarly, tracker 100 can be adapted to be attached to other surgical instruments (not shown), such as handheld drills, saws, or drill bits. Furthermore, attachment 42 attached to the distal end 38 of surgical instrument 34... Figure 2 The attachment shown is angled and drives the rotating tool on an axis (not shown) different from the instrument axis 40. For example, the attachment can be straight, tilted at 15 degrees, 45 degrees, etc.; the attachment can have various lengths, such as 30 mm, 50 mm, etc.

[0042] Surgical instruments can be small in mass and structurally weak. When a heavy tracker is attached to such a handheld surgical instrument 34, the tracker 100 causes a shift in the center of gravity, which can be irritating (e.g., due to the torque applied to the gripping hand). Furthermore, the surgical instrument 34 may deform or even be damaged (elastically or plastically) due to the weight of the attached heavy tracker 100. Trackers 100, as shown throughout the figures, generally have a reduced weight. Therefore, the aforementioned disadvantages are reduced or eliminated. The handheld surgical instrument 34 is likely to be less tiring to hold and less likely to deform due to the weight of the tracker 100.

[0043] To facilitate detachable attachment of the tracker 100 to the surgical instrument 34, the tracker 100 includes a tracker frame 102 comprising a mounting body 104 defining an instrument engagement hole 106 extending therethrough along a longitudinal axis 108. As will be discussed in more detail below, the instrument engagement hole 106 is configured to receive the surgical instrument 34 such that the instrument axis 40 is aligned with the longitudinal axis 108 of the mounting body 104. In other words, the mounting body 104 may be concentric with the body of the surgical instrument 34. The tracker frame 102 may also include a biasing body 110 supported on the mounting body 104 and extending proximally and generally parallel to the longitudinal axis 108. The biasing body 110 may define an incision 118 extending therethrough in a direction generally perpendicular to the longitudinal axis 108. The tracker frame 102 may comprise a metal (e.g., titanium), a polymer (e.g., nylon), or an epoxy resin (e.g., an aromatic epoxyamine resin). The tracker frame may include any other suitable materials for use in a medical setting, thereby providing the necessary rigid structure for the tracker 100. The tracker frame may be composed of polymers and may be manufactured using additive manufacturing techniques.

[0044] Alternatively, the tracker 100 and surgical instrument 34 can be mechanically connected for single-use. The tracker 100 and surgical instrument 34 can be integrally formed (e.g., during injection molding). For example, the tracker 100 can be integrally formed with the handle of the surgical instrument 34. With the tracker 100 attached to the instrument 34, the surgeon can use the surgical instrument 34 immediately without having to attach the tracker 100 to it. The surgeon can discard the tracker 100 and surgical instrument 34 after single-use.

[0045] To track the position and orientation of surgical instrument 34, tracker 100 includes a plurality of markers 128 selectively arranged in one or more arrays 162, 164, 166 and coupled to tracker frame 102. Tracker frame 102 may have three sides, each aligned with a corresponding radial segment 112, 114, 116, each side oriented at approximately 120 degrees to the other sides. The plurality of arrays 162, 164, 166 are positioned such that each array 162, 164, 166 is arranged on one of the three sides and oriented in different directions from each other. A first array 162 is arranged on the side aligned with a first radial segment 112, a second array 164 is arranged on the side aligned with a second radial segment 114, and a third array 166 is arranged on the side aligned with a third radial segment 116. The side aligned with the first radial segment 112 is positioned on bias body 110. The offset body 110 and the mounting body 104 cooperate to define two sides aligned with the second radial segment 114 and the third radial segment 116. Other numbers of arrays and / or other numbers of sides are also conceivable.

[0046] Although each side has a specific radial arrangement, the angles of the sides can be configured such that they are tilted toward a common vertex, such that they converge at a point beyond the proximal end 152 of the bias body 110. The bias body 110 and / or the first array 162 may define a tilt axis such that the bias body 110 extends from the mounting body 104 along this tilt axis. The tilt axis may also define three tilted segments (similar to radial segments not discussed herein) proportional to the tilt axis. Here, at least six markers 128 are arranged radially about a longitudinal axis, and at least three markers 128 are arranged radially about the tilt axis and on the bias body 110 such that one of these at least three markers 128 is located in each of the three tilted segments and spaced apart from the longitudinal axis 108 to provide clearance for the flexible power cable 48.

[0047] One method for improving the accuracy of a surgical navigation system includes maximizing the visibility of tracker 100. Improving the accuracy of tracker 100 can be achieved in several ways, such as increasing the size of tracker 100, increasing the number of markers 128, increasing the brightness of markers 128, etc. However, these methods may result in increased size and / or increased weight of tracker 100; for example, increasing the brightness of markers 128 will come at the cost of power consumption, thus shortening the duration of operation of tracker 100, or requiring a heavier battery with increased capacity.

[0048] The visibility of tracker 100 can also be improved through the strategic arrangement of markers 128 on tracker frame 102. Figure 3 andFigure 7 As best shown, three radial segments 112, 114, and 116 are defined around the longitudinal axis 108. Each radial segment 112, 114, and 116 has a volume corresponding to a respective portion of the tracker 100 and the arrangement of components of the tracker 100. As shown, the first radial segment 112 may generally be defined to be aligned with the bias body 110. The second radial segment 114 and the third radial segment 116 are aligned across the longitudinal axis 108 in a manner opposite to the bias body 110. For example, as Figure 3 As shown, each radial segment 112, 114, 116 extends 120 degrees around the periphery of tracker 100. Radial segments 112, 114, 116 are defined such that all three radial segments are equal in size.

[0049] In some configurations, tracker 100 may include a body housing 120, for example Figures 2-11 The first configuration shown and Figures 12-16 The second configuration is shown. The body shell 120 covers multiple portions of the tracker frame 102 and surrounds the inner 122 and outer 124 of the tracker frame 102 (see...). Figure 11 As will be discussed in more detail below, certain components of tracker 100 may be arranged within the interior 122 of tracker frame 102. The body housing 120 may be constructed of polymeric material, titanium, or other suitable materials. Tracker frame 102 may be a monolithic or integral structure, such that there are no separate mounting bodies 104 and / or biasing bodies 110. Suitable manufacturing processes for forming tracker frame 102 and body housing 120 may include injection molding, additive manufacturing (3D printing), computer numerical control (CNC) machining, polymer casting, vacuum forming, and blow molding, etc.

[0050] Tube guide 126 may be defined on tracker frame 102 within mounting body 104 and configured to receive surgical irrigation tube 52. Tube guide 126 receives irrigation tube 52 and neatly arranges it around tracker frame 102 in a manner that avoids the surgeon, such that the irrigation tube does not interfere with the tracker frame in unpredictable ways. Tracker 100 may include two tube guides 126 configured to receive irrigation tubes 52 with different diameters. These tube guides 126 may be identical in size or sized differently to accommodate irrigation tubes 52 of various sizes. Figure 2 As shown, the tube guide 126 is configured to guide the irrigation tube 52 through a bend of approximately 90 degrees so that it is substantially parallel to the longitudinal axis 108 when it encounters the surgical instrument 34. The tube guide can also be configured as a guide for other elongated components, such as cables for powering trackers and suction cannulas.

[0051] When in perspective (e.g. in)Figure 8 When viewed in the image, the tracker frame 102 may have a generally tetrahedral shape due to the arrangement of three sides aligned with radial segments 112, 114, and 116. Each of these sides forms one of the four faces of a tetrahedron 154, and the edges are defined at the intersection of each side. The fourth face of the tetrahedron is formed by a distal guide surface 184 on the mounting body 104. This distal guide surface 184 is generally perpendicular to the longitudinal axis 108 and defines a portion of the instrument engagement hole 106. The distal guide surface 184 is arranged opposite to the proximal guide surface 185 of the mounting body 104. The distal guide surface 184 and the proximal guide surface 185 generally form the corresponding distal and proximal ends of the mounting body 104. The tetrahedral shape can be implemented as a regular tetrahedron (having all four identical faces) or an irregular tetrahedron (where some faces are sized differently and intersect at different angles).

[0052] In some embodiments, tracker 100 may include as few as four markers 128 to track surgical instruments 34. In these embodiments, each marker 128 is coupled to tracker frame 102 and arranged at the vertices of a tetrahedral shape. Each marker 128 forms an array with two other markers 128 visible to the navigation system. Each marker 128 may be oriented differently from the other markers to maximize radial emission of light around longitudinal axis 108.

[0053] As described above, the bias body 110 is supported on the mounting body 104 and extends in the proximal direction. The bias body 110 extends from its attachment to the mounting body 104 and adjacent to the distal guide surface 184 to a proximal end 152. The length 156 of the bias body 110 is defined between the distal end 150 and the proximal end 152, corresponding to the distance between the proximal end 152 and the mounting body 104. The proximal end 152 is adjacent to a vertex of the tetrahedron 154 defined by the tracker frame 102. Figure 6 , Figure 8 and Figure 10 As best shown, the bias body 110 tapers from the distal end 150 to the proximal end 152; in other words, the proximal end 152 has a smaller profile than the distal end 150.

[0054] As also described above, the bias body 110 is typically arranged in the first radial segment 112, and further, as Figure 5 As best shown, the tracker frame 102 is spaced at a height 158 ​​from the longitudinal axis 108. Partly due to the smaller profile of the proximal end 152 and the height 158 ​​at which it is spaced, the tracker frame 102 provides a release area 160 for the flexible power cable 48 of the surgical instrument 34. Figure 5As best shown in the side view, the release area 160 is generally centered on the flexible power cable 48 and minimizes potential contact between the flexible power cable 48 and the tracker frame 102. For example, when a user such as a surgeon uses a similar... Figure 2 When the pencil gripper is used with the surgical instrument 34 as shown, the flexible power cable 48 will typically bend towards the floor and away from the surgeon. Because the flexible power cable 48 has mass, it exerts a force on the proximal end 36 of the surgical instrument 34, which becomes a torque centered on the position where the surgeon is gripping the surgical instrument 34. As the surgical instrument 34 moves during the surgical procedure, the surgeon typically becomes familiar with the forces naturally associated with the flexible power cable 48 after that movement. If the flexible power cable 48 accidentally comes into contact with something, the balance of the surgical instrument 34 is affected. When the instrument 34 is not balanced, the surgeon's fine movements may be affected, potentially leading to undesirable movement at the distal end 38 of the surgical instrument 34. By providing a large release area 160 below the bias body 110, the surgeon can move the surgical instrument 34 with confidence and an increased range of motion, while reducing the chance that the flexible power cable 48 will come into contact with the tracker frame 102. Release area 160 provides a gap for flexible power cable 48 to bend freely with a small bending radius (i.e., at a large angle to the instrument axis 40) without contacting tracker frame 102.

[0055] In addition to reducing the quality of tracker 100, it is also desirable to reduce any interference with the surgeon's visibility of the surgical site. In some cases, the surgeon may want to observe the surgical site along line of sight 188, such as... Figure 5As schematically shown, the line of sight 188 is approximately aligned with the instrument axis 40. If a large tracker is used with the surgical instrument 34, it may obstruct the surgeon's view or require the surgeon to hold the instrument 34 in a less than preferred manner, thus increasing the angle between the tracker and the longitudinal axis where the surgeon is observing the surgical site. The angle of the line of sight 188 is affected by both the length of the surgical instrument 34 and the height 158 ​​of the bias body 110 relative to the longitudinal axis 108. Therefore, it is desirable to reduce the height 158 ​​of the bias body 110 to minimize the angle of the line of sight 188. However, since the distance by which the proximal end 152 of the bias body 110 extends proximally from the distal end 150 of the bias body 110 (i.e., the length 156) is greater than the distance by which the bias body 110 is spaced from the longitudinal axis 108 (i.e., the height 158), the area of ​​each array 162, 164, 166 is still maximized, thereby maximizing the accuracy of the tracker 100. The reduced height 158 ​​of the bias body 110 allows the angle of the line of sight 188 to be less than 40 degrees. Depending on the attachment 42 connected to the surgical instrument 34, the line of sight can be further reduced to less than 30 degrees, or further reduced to less than 20 degrees. In some configurations, no part of the tracker 100 extends more than 1, 2, 3, or 4 cm from the longitudinal axis.

[0056] As described above, the tracker 100 is attached to the surgical instrument 34 via the instrument engagement hole 106, such that the instrument axis 40 and the longitudinal axis 108 are aligned. Since the defined relationship between the tracker 100 and the surgical instrument 34 helps to accurately determine the position of the surgical instrument 34, their connection should be secure and detachable. Figure 4 and Figure 9 As shown, tracker 100 may also include a retaining component 132 configured to secure surgical instrument 34 within instrument engagement hole 106. The retaining component 132 may be implemented in several different ways depending on the specific surgical instrument 34 to be tracked and the structure of tracker frame 102. Specifically, some retaining components 132 may be more suitable for tracker frame 102 comprising a metal structure, while others may be more suitable for a polymer structure. Suitability may be determined in part by the physical characteristics of the surgical instrument 34 (e.g., weight or diameter) or cost (e.g., whether tracker 100 is disposable or durable, depending on the circumstances). In some cases, tracker 100 may include more than one retaining component 132 to improve compatibility across a variety of surgical instruments 34.

[0057] The housing 46 of the surgical instrument 34 is slidably engaged with the tracker frame 102 to securely connect the tracker 100 and the surgical instrument 34. More specifically, this is achieved by aligning the instrument axis 40 and the longitudinal axis 108 and inserting the distal end 38 of the surgical instrument 34 proximally through the instrument engagement hole 106.

[0058] The first alternative to retaining component 132 is implemented as follows: Figure 8 and Figure 10 The friction clamp 134 is best shown in the diagram. Here, the clamp channel 138 is defined in the mounting body 104 in a through-type manner. Two elastic arms 140A and 140B are disposed in the clamp channel 138, each elastic arm 140A and 140B having a reference end 142A and 142B and a movable end 144A and 144B. The reference ends 142A and 142B are both connected to the mounting body 104 on one side of the clamp channel 138 and extend into the clamp channel 138 and extend to the corresponding movable ends 144A and 144B. Figure 10 As best shown, the instrument engagement hole 106 is positioned to align with the resilient arms 140A, 140B, thereby allowing the resilient arms 140A, 140B to contact opposite sides of the housing 46 of the surgical instrument 34 during use. Near each movable end 144A, 144B, each resilient arm 140A, 140B has a reduced-width overlapping portion 146A, 146B. The overlapping portion 146A of the distal resilient arm 140A has a reduced width in the distal direction, and the overlapping portion 146B of the proximal resilient arm 140B has a reduced width in the proximal direction. The reduced width of the overlapping portions 146A, 146B allows each resilient arm 140A, 140B to wrap around the housing 46 of the surgical instrument 34 in a larger manner (greater than 180 degrees) than when the movable ends 144A, 144B are abutted.

[0059] Here, to securely connect the surgical instrument 34 and the tracker 100, the diameter of the instrument engagement hole 106 is smaller than the diameter of the housing 46. When the housing 46 is slidably engaged with the mounting body 104, the movable ends 144A and 144B of the elastic arms 140A and 140B open to increase the diameter of the instrument engagement hole 106 to match the housing 46. The force from deformation causes the elastic arms 140A and 140B to apply a clamping force to the housing 46. Due to the friction and contact between the elastic arms 140A and 140B and the housing 46, the tracker 100 is thus securely held to the surgical instrument 34.

[0060] In addition to the resilient arms 140A and 140B, the retaining assembly may also include an attachment protrusion 148, shown as being disposed proximal to the instrument engagement hole 106, such as Figure 9As best shown. An exemplary attachment protrusion 148 is arranged radially about a longitudinal axis 108 and configured for engagement with the surgical instrument 34 at indexing along the instrument axis 40. Specifically, the attachment protrusion 148 engages with a complementary shaped notch in the housing 46 of the surgical instrument 34 to index the tracker frame 102 to rotational alignment about the instrument axis 40. Here, the attachment protrusion 148 has a generally rectangular profile, is adjacent to the instrument engagement hole 106, and is asymmetrically positioned such that full engagement of the surgical instrument 34 and the tracker 100 can only be achieved in a single location. Engagement of the indexing surgical instrument 34 and the tracker 100 can be achieved by using one or more attachment protrusions 148, which can provide redundancy or further retention for securely attaching the tracker 100.

[0061] The second alternative to retaining component 132 is implemented as follows Figures 12-16 and Figures 17-21 The cam locks 136′ and 136″ are shown.

[0062] As described above, tracker 100 may include a plurality of markers 128 arranged to be coupled to a plurality of arrays 162, 164, 166 of tracker frame 102. Figure 3 , Figure 7 and Figure 11 The tracker 100 is shown to be configured such that the plurality of markers 128 are further defined as at least six markers 128, wherein, Figure 7 At least one of at least six markers 128 is shown positioned on the tracker frame 102 in each radial segment 112, 114, 116. In other words, each radial segment 112, 114, 116 contains one of the markers 128, wherein some radial segments 112, 114, 116 may have more than one marker 128.

[0063] While the tracker 100 described above includes at least six markers 128, a greater number of markers 128 may be required. For example, tracker 100 may include nine markers 128 to achieve higher three-dimensional accuracy. Reducing the number of markers 128 can decrease the power consumption of tracker 100, which may be desirable in trackers 100 used for tracking motion with finite degrees of freedom (e.g., five degrees of freedom) or, for example, surgical instruments 34. Tracker 100 may include more than nine markers 128 to increase redundancy. Alternatively, the tracker may include exactly nine, ten, eleven, or twelve markers to minimize energy consumption, maximize line-of-sight, and maintain tracking accuracy. Again, alternatively, the tracker may include fewer than twelve markers.

[0064] Alternatively, or as an alternative to the above arrangement of markers 128 in each of the radial segments 112, 114, 116, tracker 100 may be configured such that a plurality of markers 128 are coupled to tracker frame 102 and arranged radially asymmetrically about longitudinal axis 108. Figure 5 and Figure 7 The edge of a longitudinal plane 168 is shown, which is parallel to the longitudinal axis 108 and bisects the instrument engagement hole 106 to define a first region 170 and a second region 172. The arrangement of the markers 128 is further defined relative to the first region 170 and the second region 172. A first number of markers 128 are located in the first region 170, and a second number of markers 128 are located in the second region 172, the first number being greater than the second number. For example, one configuration of the tracker 100 may include nine markers 128, with a first number of seven markers 128 positioned on the tracker frame 102 such that they are located in the first region 170 or above the longitudinal plane 168, and a second number of two markers 128 positioned on the tracker frame 102 such that they are located in the second region 172 or below the longitudinal plane 168. According to this example, there may be more or fewer markers 128 in either region 170 or 172, such that a first number of markers 128 in the first region 170 is greater than a second number of markers 128 in the second region 172.

[0065] Tracker 100 is adaptable to be compatible with a variety of different surgical navigation systems and position tracking technologies. For example, tracker 100 may employ a passive tracking marker that reflects infrared light or radiation emitted from a camera unit or another light source. Although one embodiment of the navigation system is described herein, the navigation system may have any other configuration suitable for monitoring tracker 100, and it may have various types and configurations. For example, the navigation system may include other types of cameras and / or markers 28.

[0066] In some embodiments, the navigation system may be radio frequency (RF) based. For example, tracker 100 may include an RF transmitter or repeater, which may be passive or actively activated. Alternatively, in some embodiments, the navigation system may be electromagnetic (EM) based. For example, the navigation system may include an EM transceiver coupled to a computing device, controller, etc. Here, tracker 100 may include EM components attached thereto (e.g., various types of magnetic trackers, electromagnetic trackers, inductive trackers, etc.), which may be passive or actively activated.

[0067] As shown throughout the accompanying drawings and specifically referenced again. Figure 7The marker 128 is an infrared emitter capable of emitting infrared radiation or light that can be sensed by the surgical navigation system. Infrared wavelengths are preferred because the ambient lighting used by the surgeon emits light in the visible spectrum, but the wavelength of infrared light makes the brightness of the marker 128 detectable by the surgical navigation system substantially independent of the ambient lighting brightness. Therefore, because the marker 128 emits infrared light, it can operate at lower brightness, which reduces the current required to power the marker 128. The current required to power the marker can be as low as 15 mA or less.

[0068] Here, the infrared emitter is an infrared light-emitting diode (IR-LED), which can emit infrared radiation and light at a relatively low power level. The current of at least one IR-LED can be limited by the internal resistance of the IR-LED and the resistance of at least one resistor connected in series with at least one IR-LED. The current of at least one IR-LED can be limited by one or more resistors connected in series with at least one IR-LED.

[0069] Tracker 100 includes circuitry placed within tracker frame 102, which will be discussed further below. The circuitry includes IR-LEDs (shown as marker 128), a battery 182, and resistors (not shown). The circuitry includes wires (not shown) electrically connecting the battery 182 to each IR-LED. The IR-LEDs, battery 182, and resistors are connected in series. Therefore, the resistance of the resistor limits the current to the IR-LED. The resistor has a resistance such that the current to the IR-LED does not exceed approximately 15 mA. In one embodiment, the IR-LEDs are connected in parallel with each other. Therefore, if one IR-LED fails, the electrical connection between the battery 182 and the remaining IR-LEDs is not interrupted. Each resistor forms a series circuit with its corresponding IR-LED. Furthermore, each IR-LED contributes its own resistance to the resistance of the resulting series circuit. According to Ohm's law, current is inversely proportional to resistance. Therefore, by adjusting the resistance of each resistor, the current through that resistor and through its corresponding IR-LED can be adjusted. An exemplary circuit configuration can be found in U.S. Patent Publication No. 2019 / 0321108, which is incorporated herein by reference.

[0070] In one configuration, tracker 100 includes four resistors, equal to the number of IR-LEDs. Alternatively, tracker 100 may include a different number of resistors. Each resistor is disposed between battery 182 and its corresponding IR-LED. The resistors are disposed within tracker frame 102, and each resistor is connected in series to its corresponding IR-LED. The resistors are electrically connected between the IR-LED and the positive terminal of battery 182. Alternatively, at least one resistor may be electrically connected between a corresponding IR-LED and the negative terminal of battery 182. This embodiment includes a smaller number of resistors and therefore has lower material costs. Alternatively, more than one resistor may be connected in series to multiple IR-LEDs. For example, two resistors may each be connected in series to an IR-LED.

[0071] The circuit may further include a switch 186, which is user-operable and configured to electrically open and close the circuit. Thus, the IR-LED can be operated by actuating switch 186, which opens and closes the circuit connecting battery 182 to the IR-LED. Alternatively, multiple switches may be provided, configured to individually control the power supply to each IR-LED. As another alternative, tracker 100 may include at least one disposable switch. This disposable use can be achieved by switch 186, which includes a removable insulating material (e.g., paper or polymer strip, such as Mylar or Kapton), wherein switch 186 is configured to close the circuit once the insulating material is removed. Alternatively, the disposable switch may be implemented as exposed contacts shorted together when the tracker 100 is assembled.

[0072] The circuit can be configured to limit the radiant intensity of at least one IR-LED to no more than 40 microwatts (μW / sr) per steradian, preferably 20 μW / sr, and more preferably 10 μW / sr. The circuit can be configured to limit the maximum or average radiant intensity of at least one IR-LED to a range between 0.1 μW / sr and 40 μW / sr, for example, between 0.5 μW / sr and 20 μW / sr, or between 1 μW / sr and 10 μW / sr. The circuit can be configured to limit the radiant intensity of some or all of a plurality of IR-LEDs to 40 μW / sr or less, as described above.

[0073] Battery 182 can be implemented as a single button cell (also known as a coin cell). However, battery 182 may also comprise multiple cell units. Button cells are lightweight, thus reducing the weight of tracker 100. Battery 182 may have a weight of less than 5 grams, for example, 3 grams. Battery 182 can be a non-rechargeable primary battery, or alternatively, a rechargeable secondary battery. Battery 182 may use an anode material including zinc or lithium. Battery 182 can be an alkaline battery or a lithium battery, such as the commonly used CR2032 or CR2025 batteries with a spherical or cylindrical shape. Alternatively, battery 182 can be a zinc-air battery. The capacity of battery 182 may be between 100 mAh and 1000 mAh (e.g., between 200 mAh and 400 mAh).

[0074] exist Figure 3 and Figures 5-6 In the figures, battery 182 is shown in dashed lines to indicate that it is placed within the interior 122 of tracker 100 to protect it from contaminants (e.g., blood, water, and disinfectants) that may occur during surgery. Throughout the various embodiments shown in the figures, battery 182 may be removable from tracker 100 by the user. Alternatively, battery 182 may be non-removable from tracker 100 (e.g., when tracker 100 is configured as a disposable item). Since the current is limited for at least one of the plurality of markers 128, battery 182 may be sufficient as a power source and an external power source may not be required. Tracker 100 may not include a power cord connected to an external power source.

[0075] Battery 182 provides, for example, a DC voltage of 3V. Each IR-LED has, for example, an operating voltage of 1.5V. Therefore, the battery voltage drops by 3V – 1.5V = 1.5V at each resistor. Each resistor has a resistance of 150Ω. Therefore, the current through each resistor and thus through each IR-LED is 1.5V / 150Ω = 10mA. Due to the resistors, the circuit is configured to limit the current to each IR-LED to no more than 15mA. In this way, the circuit also limits the radiant intensity of at least one IR-LED to no more than 40µW / sr lumen.

[0076] The button cell battery 182 is lightweight and has a small capacity (e.g., 520mAh). Because the circuitry is optionally configured to limit the current to each IR-LED to no more than 15mA or 20mA, the capacity of the button cell battery is still sufficient to safely operate the tracker 100 during typical surgical navigation procedures. For example, with a CR2032 battery having a capacity of 520mAh and each powering four IR-LEDs at a current of 10mA, the tracker 100 can operate sustainably for 520mAh / (4 x 10mA) = 5.5 hours. The tracker 100 can be configured to accommodate additional batteries to extend its operating time. For example, a tracker with two 520mAh batteries can operate for more than 10 hours.

[0077] Because the current load is reduced, tracker 100 is configured for continuous operation of marker 128. Tracker 100 can be configured to operate at least two of the multiple markers 128 simultaneously. Tracker 100 can also be configured to operate all markers 128 simultaneously. Alternatively, tracker 100 can be configured to operate multiple markers 128 sequentially.

[0078] Alternatively, tracker 100 can be configured for quasi-continuous or pulsed operation. Quasi-continuous operation may also include circuitry capable of adjusting the brightness of marker 128, for example via pulse width modulation (PWM) circuitry, wherein the duty cycle of the electrical signal supplied to marker 128 is modified such that the on-time is longer than the off-time, thereby increasing brightness, and vice versa. Quasi-continuous operation can be performed at an operating frequency exceeding 0.5 kHz. This quasi-continuous operation reduces the power consumption of tracker 100.

[0079] In addition to the aforementioned IR-LED, tracker 100 may also include circuitry for a status indicator electrically connected to at least one of the IR-LED, battery, and resistor. In one embodiment, the status indicator may include an LED emitting visible light (i.e., non-infrared light), allowing the surgeon to easily verify that tracker 100 has been activated and is operational. The status indicator may be configured to provide the surgeon with additional diagnostic or operational information, such as remaining battery capacity. For example, the status indicator may flash or blink when the battery voltage corresponds to a first level, and may turn off when the battery voltage corresponds to a second level. The status indicator may also utilize more than one LED or LEDs capable of emitting more than one color. If more than one LED is used, the battery voltage level may correspond to the number of LEDs lit simultaneously. If multi-color LEDs are used, the colors may correspond to the battery voltage level.

[0080] As described above, the markers 128 are positioned around the longitudinal axis 108 either by being arranged in each of the radial segments 112, 114, 116 or by a number located on one side of the longitudinal plane 168. These configurations increase the visibility of the tracker 100 and thus improve the ability of the surgical navigation system to accurately determine the position and orientation of the surgical instruments 34. Furthermore, these configurations position the markers 128 at multiple angular locations around the longitudinal axis 108, enabling the markers 128 to emit infrared radiation or light radially around at least 260 degrees of the longitudinal axis 108. This radial emission is shown in… Figure 7 In the diagram, an exemplary emission pattern of each of a plurality of markers 128 is shown relative to tracker 100 and surgical instrument 34. The radial emission shown here is 360 degrees around longitudinal axis 108. Again, marker 128 is an IR-LED with a hypothetical total emission angle 174 of approximately 150 degrees. In other words, each IR-LED is capable of emitting at a normal 175 with peak intensity (see [reference]). Figure 25 The IR-LED emits radiation at an angle of 75 degrees to its centerline, typically referred to as a half-angle. The normal 175 of the IR-LED is generally orthogonal to the mounting plane of the IR-LED and defines the centerline of the peak intensity. IR-LEDs with larger or smaller half-angle values ​​can be implemented in alternatives, such as 65 degrees or 85 degrees. An IR-LED configuration with an exemplary emission angle 174 of 150 degrees allows the radiation or light emitted from the IR-LED to be visible to a navigation system via approximately 360 degrees of rotation of the tracker 100 along the longitudinal axis 108, as may occur during surgery as the surgeon manipulates the surgical instrument 34 as needed.

[0081] In some embodiments, the distance between at least two of the plurality of markers 128 may be less than 70 millimeters (mm). The distance between at least two of the plurality of markers 128 may be in the range between 1 mm and 70 mm, for example, between 3 mm and 35 mm or between 5 mm and 30 mm. As will be discussed below, the markers 128 may be placed in a common plane. Alternatively, the markers 128 may be configured such that they are not arranged in a common plane.

[0082] Turning Figure 11Each circuit includes an IR-LED (i.e., marker 128), which is attached (e.g., via soldering) to printed circuit boards (PCBs) 176, 178, and 180, which are in turn coupled to tracker frame 102. Three PCBs 176, 178, and 180 are shown here, with three markers 128 coupled to each PCB. Each of PCBs 176, 178, and 180 is electrically connected to a voltage source (shown here as battery 182) that provides power to the multiple markers 128. PCBs 176, 178, and 180 have a generally flat and planar configuration to which the markers 128 and other components (e.g., resistors discussed herein) are attached. More specifically, each PCB 176, 178, 180 defines a plane 176A, 178A, 180A, which is generally perpendicular to the direction of radiation emitted by the corresponding marker 128. Two or more, or three or more, PCBs 176, 178, 180 are arranged such that they are not parallel to each other. In some configurations, a battery 182 may be connected to circuitry on only one of the PCBs 176, 178, 180. Here, the battery 182 is electrically connected to the upper PCB 176. Each of the other PCBs 178, 180 is electrically connected to the upper PCB 176 via wiring to power all markers 128. Alternatively, all markers 128 may be connected to a single flexible PCB configured with flexible portions, thereby allowing the PCB to have a single surface oriented along at least three different directions.

[0083] The following text will combine Figure 22 The tracker shown As discussed in the fourth embodiment, some embodiments may include a battery socket (e.g., a tray). It retains battery 182 and can be used with the tracker frame. The battery 182 is slidably engaged to position it in electrical communication with the IR-LED. In some configurations, the battery 182 and battery tray 183 are arranged to directly engage the PCB in a low-profile configuration. When the battery 182 is configured as a coin cell (e.g., CR2032, as described above), one of the circular faces of the battery contacts a conductive element of the PCB. By positioning the battery 182 in contact with the PCB, the overall height of the PCB assembly is minimized. As described above, reducing the height of the tracker 100 advantageously reduces the angle of view 188 during use.

[0084] Since the markers 128, when configured as infrared emitters or IR-LEDs, are connected to the corresponding non-parallel PCBs 176, 178, 180, each marker 128 emits radiation perpendicular to the planes 176A, 178A, 180A on which it is disposed. Therefore, the markers 128 emit radiation in at least as many directions as the non-parallel planes 176A, 178A, 180A. (See again...) Figure 7 The diagram shows three different directions.

[0085] To utilize the radial emission characteristics provided by the configuration of the markers 128, the surgical navigation system may be able to determine which markers 128 correspond to a specific arrangement on the tracker frame 102. As described above, a plurality of markers 128 are arranged to form at least two arrays, each array having at least three markers 128, a portion of each array being coupled to the bias body 110. More specifically, Figure 11 The tracker 100 shown includes three arrays 162, 164, and 166 connected to the tracker frame 102. The first array 162 is connected to the bias body 110 and faces... Figure 11 The top of the second array 164 is connected to the mounting body 104 and the biasing body 110 and faces the top. Figure 11 The lower left. The third array 166 is also connected to the mounting body 104 and the biasing body 110 and faces. Figure 11 It is located at the lower right. However, other array arrangements can be envisioned.

[0086] In addition to a portion of each of at least two arrays 162, 164, and 166 being coupled to the bias body 110, a portion of each of at least two arrays 162, 164, and 166 is positioned proximally to the mounting body 104, and this portion of at least two arrays 162, 164, and 166 located proximally to the mounting body 104 includes exactly one marker 128. As described above, a portion of the bias body 110 extends proximally from the mounting body 104 and terminates at a proximal end 152. This proximal end 152 of the bias body 110, along with the same tracker frame 102, is positioned proximally to the proximal end 36 of the surgical instrument 34. Figure 7 As shown in the optimal configuration, three markers 128 from the first array 162, the second array 164, and the third array 166 are arranged on the tracker frame 102, proximal to the proximal end 36 of the surgical instrument 34, near the proximal end 152 of the bias body 110.

[0087] The camera includes two lenses for focusing infrared light emitted by multiple IR-LEDs. These lenses allow more light to enter the camera compared to a non-focusing opening, such as a slit. Therefore, the camera can detect low-brightness light sources, such as IR-LEDs operating with limited current.

[0088] The camera also includes two two-dimensional image sensors 66. These two-dimensional image sensors 66 are capable of sensing solid angles (i.e., two-dimensional angles). In contrast, conventional one-dimensional sensor arrays typically require synchronization with detected light sources, and may only allow tracking of a single light source per scan. Since the two-dimensional image sensors 66 can detect all IR-LEDs at once, the tracker 100 can be configured to operate at least two, and in particular all, of multiple IR-LEDs simultaneously. This simultaneous operation does not require synchronization between the camera and the tracker 100. Therefore, the tracker 100 does not require a communication interface (e.g., a wireless transceiver) for communicating with the camera, which further reduces the weight of the tracker 100. Other advantages of the transceiver-free tracker 100 include preventing unwanted interference between the transmitted signal and external systems, preventing unwanted signal interference in the received signal, reduced cost, and reduced complexity.

[0089] The surgical navigation system may include two two-dimensional image sensors, which are part of a stereo camera. This stereo camera is capable of capturing three-dimensional image data. Therefore, the known spatial relationship between IR-LEDs is unnecessary. Thus, a stereo camera can be used when multiple individual IR-LEDs are attached to the patient. Due to manual attachment, the spatial relationship between IR-LEDs is unknown. However, because the stereo camera is capable of capturing three-dimensional image data, it can track the IR-LEDs.

[0090] In one configuration, identification of each of arrays 162, 164, 166 is performed by the surgical navigation system by determining the distance to each marker 128 and performing triangulation of the position relative to the camera, as described above. Each array 162, 164, 166 can be independently tracked in more than one dimension (e.g., 2D or 3D) by configuring arrays 162, 164, 166 using more than one marker 128. As shown throughout the figures, each array 162, 164, 166 is defined by three markers 128, for a total of nine markers 128. The specific arrangement of the markers 128 can vary between each array 162, 164, 166 to accurately distinguish each array 162, 164, 166. In one example, the first array 162 may define a first region 162A (… Figure 6 ), which is the region of a triangle whose vertices are located at a common reference point on each of the corresponding markers 128. Similarly, the second array 164 may define a second region 164A (Figure 8 Furthermore, the third array 166 can define the third region 166A ( Figure 5 Both the second region 164A and the third region 166A are regions of triangles whose vertices are located at a common reference point on each of the corresponding markers 128. Here, the first region 162A may be larger than the second region 162A, and the second region 164A may be larger than the third region 166A.

[0091] In another example, in particular Figures 22-26 The tracker shown (This will be discussed in more detail below), Second Area and the third region They can be equal. Here, the second array... and the third array Markers can be configured at the same positions relative to the corresponding array. Second array and the third array The dimensions of the invention can be the same (or substantially the same) in opposite or mirror configurations. This provides a pleasing appearance and reduced manufacturing costs.

[0092] Now for reference Figures 12-16 Another embodiment of tracker 100' is shown, wherein tracker frame 102' includes a cam lock retaining mechanism 136'. In many respects, tracker 100' may be similar to the trackers previously described, wherein similar numbers (plus apostrophes (')) correspond to similar components, and any disclosure shared by corresponding components that may be omitted for brevity should not be construed as limiting. It should be understood that corresponding components on tracker frame 102' may be modified in a suitable manner to allow surgical instruments 34 to be inserted into and removed from instrument engagement holes 106' in the aforementioned manner. Furthermore, it should be understood that although discussed in the context of retaining mechanism 132', which may be integrated with or coupled to any mounting body 104' (e.g., the previously described mounting body 104'), in general, this disclosure is applicable to tracker 100' and / or tracker frame 102'.

[0093] exist Figures 12-16In the diagram, tracker 100′ is shown as including tracker frame 102′, which has mounting body 104′ and biasing body 110′ supported thereon. Similar to the above, mounting body 104′ defines instrument engagement hole 106′, which is configured to slidably engage surgical instrument 34 at its proximal end 36. The distal end 38 of surgical instrument 34 is inserted proximally into instrument engagement hole 106′ and slides distally until a collar, having a diameter larger than that of instrument engagement hole 106′, abuts the mounting body 104′ and is attached to the proximal end 36 of surgical instrument 34. The collar defines a complementary recess in the housing 46 of surgical instrument 34, the recess being configured to engage an attachment protrusion 148′ adjacent to instrument engagement hole 106′. Here, the retaining mechanism 132' has a release knob with an inclined cam surface that engages a collar of the surgical instrument 34. This release knob biases the surgical instrument 34 toward engagement with the instrument engagement hole 106'. Moving the knob to the release position disengages the collar and allows the surgical instrument 34 to be removed from the tracker 100'.

[0094] Figure 16 Radial segments 112′, 114′, and 116′ are shown when they are arranged around the longitudinal axis 108′. The asymmetrical arrangement of markers 128′ on the tracker body 102′ improves the visibility of the tracker 100′ to the surgical navigation system by emitting infrared radiation or light at least 260 degrees around the longitudinal axis 108′. Some arrangements of the markers 128′ can emit light at 360 degrees around the longitudinal axis 108′.

[0095] Now for reference Figures 17-21 Another embodiment of tracker 100″ is shown, wherein tracker frame 102″ is a spatial frame structure. Here, tracker 100″ also includes a cam lock holding mechanism 136″. In many respects, tracker 100″ may be similar to the tracker previously described, wherein similar numbers (plus double apostrophes (″)) correspond to similar components, and any disclosure shared by corresponding components that may be omitted for brevity should not be construed as limiting. It should be understood that corresponding components on tracker frame 102″ may be modified in a suitable manner to allow surgical instruments 34 to be inserted into and removed from instrument engagement holes 106″ in the aforementioned manner. Furthermore, it should be understood that although discussed in the context of tracker frame 102″, this disclosure is generally applicable to tracker 100″ and / or tracker frame 102″.

[0096] exist Figures 17-21In the diagram, tracker 100″ is shown as including tracker frame 102″, which has mounting body 104″ and biasing body 110″ supported thereon. Similarly, mounting body 104″ defines instrument engagement hole 106″, which is configured to slidably engage surgical instrument 34 at its proximal end 36. The distal end 38 of surgical instrument 34 is inserted into the proximal side of instrument engagement hole 106″ and slides distally until a collar coupled to the proximal end 36 of surgical instrument 34 and having a diameter larger than that of instrument engagement hole 106″ abuts the mounting body 104″.

[0097] In this embodiment, the tracker frame 102″ is formed of a bent plate, thereby forming each of the three sides. The tracker frame 102″ is bent such that each side is aligned with... Figure 21 The three radial segments 112″, 114″, and 116″ shown are aligned. The tracker frame 102″ is made of a lightweight and durable metal material, such as titanium. Because the tracker 100″ is designed to be reusable, this construction allows for the repair or replacement of certain components. For example, at least two arrays 162″, 164″, and 166″ are connected to the tracker frame 102″ using threaded fasteners. Similarly, this allows at least two arrays 162″, 164″, and 166″ to be removed for cleaning.

[0098] As previously described, a plurality of markers 128″ are arranged on the tracker frame 102″ such that at least one marker 128″ is positioned in each of the radial segments 112″, 114″, and 116″. Furthermore, Figure 21 The edge of the longitudinal plane 168″ is shown, which is parallel to the longitudinal axis 108″ and bisects the instrument engagement hole 106″ to define a first region 170″ and a second region 172″. The arrangement of the markers 128″ is further defined relative to the first region 170″ and the second region 172″, wherein a first number of a plurality of markers 128″ is positioned in the first region 170″ and a second number of a plurality of markers 128″ is positioned in the second region 172″, the first number being greater than the second number.

[0099] Figure 18 The proximal end 152" of the bias body 110" is shown, which is spaced apart around the longitudinal axis 108" to define a release region 160" that provides clearance for the flexible power cable 48. Here, portions of at least two arrays 162" , 164" , 166" are positioned proximal to the mounting body 104" and this portion includes exactly one marker 128".

[0100] Some embodiments of tracker 100 may be configured with a PCB as an outward-facing outer surface, where these surfaces are exposed and readily come into contact with debris or fluids. Short circuits can damage components connected to the PCB (e.g., marker 128 or resistors), potentially leading to malfunction of tracker 100. The components forming each tracker array and the PCB can be protected by applying a conformal coating that forms a barrier on the PCB to prevent debris and liquid ingress. An exemplary conformal coating may include a parylene film applied to the assembled PCB.

[0101] Now for reference Figures 22-26 An optical tracker without a handheld surgical instrument 34 is shown. Another alternative implementation. In the tracker In this embodiment, the holding mechanism 132 employs a rod clamp. In the form of. As mentioned above, in many respects, tracker 100' can be similar to the one described above, where similar numbers (plus apostrophes) Any disclosure shared by corresponding components that correspond to similar parts and may be omitted for brevity should not be construed as restrictive. Here, the lever clamp... Includes two flexible arms It is connected to the tracker frame at the first end. And at the second end they are spaced apart from each other, and the rods Pivotibly connected to the elastic arm The second end. Elastic arm. Collaboration to define instrument engagement holes Its installation body Inner along the longitudinal axis extend.

[0102] Bias body Supported by the mounting body It extends upwards and along the proximal direction. The biased body... With longitudinal axis Spacing out and defining the incisions The incision Approximately perpendicular to the longitudinal axis Extending in the direction through the bias body In biased ontology Inside, what is shown here is the rod. The rod With tracker framework The shape is roughly the shape of a tetrahedron, with a corresponding triangle shape on one face. (Rock) The tracker frame can be pivoted between a clamping position and a released position (not shown) to hold the tracker frame. Secure it to the surgical instrument 34.

[0103] Each elastic arm It has an ear at one end Rod With each ear It engages and can pivot about a rod axis, which is typically perpendicular to the tracker frame. longitudinal axis In one case, each ear A rod support hole can be defined, which extends along the rod axis through the lug. Rod It may include two pins arranged on the rod axis and capable of engaging with rod support holes. The engagement between the pins and the rod support holes is beneficial to the rod. Pivoting motion between the clamping and releasing positions. In another case, the lever... and ears It can be configured with an ear The protruding pin and the rod are fixed in place. The rod support hole in the middle.

[0104] As mentioned above, the tracker framework It can include plastic or polymer materials. Therefore, the tracker frame... The tracker frame can be formed using injection molding or additive manufacturing processes. Formed as a single whole. By using the tracker framework. Forming it into a single unit can eliminate issues such as clamps Assembled into tracker frame Such steps. In addition, the tracker framework. Dimensional accuracy can be improved by reducing tolerance stacking. Furthermore, the tracker frame can be improved by eliminating any joints between components. The stiffness can be reduced. This eliminates the geometrical issues that would arise from connecting multiple components together, further reducing the tracker frame's rigidity. The weight and precision of the mating surfaces are required. When formed from plastic or polymer materials, the elastic arm... It can be slightly bent, which allows the ear to They are shifted relative to each other, thus allowing the defined distance between them to be shortened. When the user moves the lever... When pivoting from the released position to the clamping position, the ear They were moved closer together, which narrowed the instrument engagement hole. The diameter. When surgical instrument 34 is inserted into the instrument engagement hole. And the rod When pivoted into the clamping position, the elastic arm It is tightened against the outer surface of the surgical instrument 32 to prevent relative movement between them.

[0105] The trackers 100, 100′, and 100″ mentioned in this article The structure is optimized to reduce mass and size to facilitate the formation of low-cost disposable trackers. In some embodiments, the tracker including a battery may weigh 40g. Some embodiments of the tracker including a power source may have a mass of less than 50g, 40g, or less than 35g.

[0106] A method for calibrating and registering a tracker 100 and a tracking array for surgical procedures using a locator is also disclosed. (To be continued) Figures 24-26 The method steps are illustrated for calibrating and registering a tracking array having a first tracking surface TF1 and a second tracking surface TF2 connected to each other. The tracking array may also include a third tracking surface TF3 connected to the first tracking surface TF1 and the second tracking surface TF2. The method steps are described in the tracker above. These steps are described in the context of the fourth embodiment; however, they are applicable to trackers 100, 100', 100'', and 100'' described herein. Each of them. Therefore, any tracker 100, 100′, 100″, ... All can be calibrated according to the method described below. The elements described in conjunction with this method are substantially similar in each of the four embodiments, wherein similar numbers correspond to similar parts and any apostrophes are omitted for clarity.

[0107] The tracker is calibrated in the operating room to achieve high tracking accuracy. High tracking accuracy corresponds to accurate and precise measurement of the relative position of each optical tracking element. By calibrating the tracker in place, the navigation system can accurately measure the position of each optical tracking element to compensate for high manufacturing tolerances. Due to the high accuracy achievable through the calibration process, the tracker can be manufactured in a cost-effective and lightweight manner. In an exemplary embodiment of the tracker, the tracker frame can be formed using stereolithography and epoxy resin.

[0108] Calibration and registration of the tracking array can be initiated by a user (e.g., a surgeon) before or at the start of surgery by connecting tracker 100 to medical device 34 or the patient and activating tracker 100 (e.g., by activating a disposable switch). Alternatively, the calibration and registration procedure can be initiated automatically by surgical navigation system 12 upon detection of the tracker or via user input 16. Upon initiation of calibration and registration, navigation processor 18 can provide the user with a first set of instructions on display unit 14. These instructions can be a static list of steps or can be dynamically updated, as discussed below.

[0109] Some embodiments of the surgical navigation system 12 include a storage device (not shown) on which manufacturing dimensions of a tracking array may be stored. The manufacturing dimensions may include a first set of geometric data, including geometric data for a first tracking surface TF1, a second tracking surface TF2, and a third tracking surface TF3. The first tracking surface geometric data may include data indicating the expected relative positions of a plurality of optical tracking elements 128 on the first tracking surface TF1, their positions relative to each other, and the expected orientation of the plurality of optical tracking elements 128 on the first tracking surface. The second tracking surface geometric data may include data indicating the expected relative positions of the plurality of optical tracking elements 128 on the second tracking surface TF2, their positions relative to each other, and the expected orientation of the plurality of optical tracking elements 128 on the second tracking surface. The third tracking surface geometric data may include data indicating the expected relative positions of the plurality of optical tracking elements 128 on the third tracking surface TF3, their positions relative to each other, and the expected orientation of the plurality of optical tracking elements on the third tracking surface TF3. This data may also include distances between the individual optical tracking elements 128, angles of normals 175°, expected manufacturing position tolerances, and other data characterizing the tracking array.

[0110] The first tracking surface TF1, the second tracking surface TF2, and the third tracking surface TF3 may each include a plurality of optical tracking elements 128 detectable by the navigation system 12. Calibration of the tracker 100 may be initiated by positioning the tracking array such that the plurality of optical tracking elements 128 of at least two of the first tracking surface TF1, the second tracking surface TF2, and / or the third tracking surface TF3 are at least partially visible to the locator 22. In a next step, while the plurality of optical tracking elements 128 are visible to the locator 22, the relative positions of the plurality of optical tracking elements 128 are measured.

[0111] As described above, the optical tracking element 128 (or marker) can be an infrared light-emitting diode (IR-LED) that emits light in the infrared spectrum in the form of a generally conical beam along the normal 175. However, the optical tracking element 128 can be implemented as a reflective tracking element or retroreflector that reflects light from the source near the locator 22 in a direction closely aligned with the infrared light source.

[0112] As previously described, each tracking element 128 has a normal 175 that is approximately orthogonal to the corresponding tracking surface and defines a center line of peak intensity. In other words, the orientation of the normal 175 represents the orientation of the optical tracking element 128. In addition to measuring the relative positions of the multiple optical tracking elements 128, the navigation system 12 can detect the normals 175 of the multiple optical tracking elements 128, while the multiple optical tracking elements 128 are visible to the locator 22 on each tracking surface. For some tracker configurations, such as when the tracker comprises an array defining three distinct regions, the detection step can be omitted.

[0113] Some embodiments of the tracker 100 can be configured such that the tracking array has two tracking surfaces, wherein the optical tracking elements 128 are arranged in the same geometric configuration. In other words, the optical tracking elements 128 are arranged on one tracking surface in the same relative position to the optical tracking elements 128 on the other tracking surface. Figure 24 In the illustrative example shown, the second tracking surface TF2 is one tracking surface, and the third tracking surface TF3 is another tracking surface. The distance or relative position between each optical tracking element 128 on the second tracking surface TF2 and the third tracking surface TF3 is the same. Furthermore, the optical tracking elements 128 on each of those tracking surfaces define the same triangular region. However, as Figure 24 As can be seen, the second tracking surface TF2 and the third tracking surface TF3 are mirror-arranged structures, wherein the normals 175 of the individual optical tracking elements 128 are opposite to each other. By determining the normal 175 / orientation of each visible optical tracking element 128 or at least one optical tracking element 128 on each surface, the navigation processor can distinguish between two or more tracking surfaces.

[0114] Once the normal 175 of the visible optical tracking element 128 has been detected, the optical tracking element 128 can be grouped into a first rigid body and a second rigid body based on the measured relative position and orientation, each of the first rigid body and the second rigid body including at least one tracking element 128. Based on the measured relative position and orientation of the plurality of optical tracking elements 128 on the third tracking surface TF3, the plurality of visible optical tracking elements 128 can be further grouped into a third rigid body.

[0115] The method further includes the step of positioning the tracking array such that at least one of the optical tracking elements 128 of the first tracking surface TF1, at least one of the optical tracking elements 128 of the second tracking surface TF2, or at least one of the optical tracking elements 128 of the third tracking surface TF3 are simultaneously visible to the positioner 22. The positioner 22 is used to measure the relative position when at least one optical tracking element 128 belonging to the corresponding first tracking surface TF1, second tracking surface TF2, or third tracking surface TF3 is simultaneously visible. In some configurations, the positioning step may require that at least three optical tracking elements 128 of the first tracking surface TF1 be simultaneously visible, while at least one optical tracking element 128 of the second tracking surface TF2 or the third tracking surface TF3 is visible. Similarly, to establish a correspondence between the second tracking surface TF2 and the third tracking surface TF3, at least three optical tracking elements 128 of the second tracking surface TF2 may need to be simultaneously visible with at least one optical tracking element 128 of the third tracking surface TF3. It should be understood that it is not limited to three tracking surfaces, and this implementation is useful for trackers with only two or four or more surfaces.

[0116] Using the navigation processor 18, a composite rigid body can be created based on: a first rigid body, a second rigid body, and a third rigid body; and the measured relative positions of at least one optical tracking element 128 of the first tracking surface TF1, at least one optical tracking element 128 of the second tracking surface TF2, and at least one optical tracking element 128 of the third tracking surface TF3. Alternatively, the composite rigid body can be created solely based on the measured relative positions of at least one optical tracking element 128 of the first tracking surface TF1, at least one optical tracking element 128 of the second tracking surface TF2, and at least one optical tracking element 128 of the third tracking surface TF3.

[0117] The tracker can be identified by measuring the relative positions of multiple optical tracking elements 128, which are at least three optical tracking elements on a single tracking surface. In some embodiments, the identification step may be further based on orientation data detected by the multiple optical tracking elements.

[0118] The navigation processor can identify the tracking array by comparing the positions and / or detected orientations of at least three optical tracking elements on the tracking surface with a first set of geometric data. This identification can be based on the expected orientations of multiple optical tracking elements 128 on the first tracking surface TF1, the expected orientations of multiple optical tracking elements 128 on the second tracking surface TF2, and / or the expected orientations of multiple optical tracking elements 128 on the third tracking surface TF3. Despite the fact that the visibility of the optical tracking elements may be limited to avoid reducing measurement accuracy at wide angles, the positioner 22 may be able to identify the tracker by utilizing this orientation. This identification step can trigger the calibration workflow.

[0119] As described above and as Figure 26 As shown, to facilitate accurate calibration, the navigation system 12 can display calibration instructions to the user via the display unit 14. These displayed instructions can be updated based on which calibration step the user is currently performing or which calibration step has just been completed. The instructions may include graphics indicating to the user that the tracking array is rotated relative to the locator 22 such that at least one optical tracking element 128 of the first tracking surface TF1 and at least one optical tracking element 128 of the second tracking surface TF2 are simultaneously visible to the locator 22. The instructions may also include graphics indicating to the user that the tracking array is rotated relative to the locator 22 such that at least one optical tracking element 128 of the first tracking surface TF1 and at least one optical tracking element 128 of the third tracking surface TF3 are simultaneously visible to the locator 22. Furthermore, the instructions may subsequently include graphics indicating to the user that the tracking array is rotated relative to the locator 22 such that at least one optical tracking element 128 of the second tracking surface TF2 and at least one optical tracking element 128 of the third tracking surface TF3 are simultaneously visible to the locator 22. The same step can be indicated for both the third tracking surface TF3 and the first tracking surface TF1.

[0120] The calibration and registration method may also include the step of identifying a medical device 34 associated with tracker 100. Identification of the medical device 34 is based on associating a composite rigid body of a tracker array formed by a navigation processor with the medical device 34, which can be used in surgical procedures. By associating the composite rigid body with the medical device 34, the tracking array can be further assigned to a specific medical device 34 in the same manner. The method may also include determining the positional relationship between a portion of the medical device 34 and the composite rigid body by positioning a portion of the medical device 34 at a known reference location. Various techniques, such as triggering a reference location being tracked by locator 22, can be used to calibrate to the medical device. In one example, the reference location is a known location on a trackable calibration device.

[0121] Terms:

[0122] I. A method of operating a tracker, wherein the tracker includes a tracker frame 102 and circuitry supported by the tracker frame 102, wherein the circuitry includes at least one infrared light-emitting diode (IR-LED), and wherein the circuitry further includes a battery or a wireless power receiving device configured to wirelessly receive power, the method comprising: supplying power from the battery or the wireless power receiving device to operate the at least one IR-LED; and limiting the current of at least one of the at least one IR-LEDs to no more than 15 mA via the circuitry.

[0123] II. A method for tracking the position and orientation of a tracker coupled to a surgical instrument within a surgical navigation system, the tracker defining a longitudinal axis and comprising at least three arrays, each of the at least three arrays having at least three infrared emitters, the at least three arrays being arranged radially around the longitudinal axis, the method comprising: measuring the position of each of the at least three infrared emitters to determine the position and orientation of each array; calculating a correction factor corresponding to the position of at least one marker of each array relative to the other arrays; determining the relative position and orientation of at least one marker of each array visible to the surgical navigation system; and determining the position and orientation of the tracker by correlating the relative position and orientation of the at least one marker of each array with the absolute position of the tracker using the correction factor.

[0124] III. A method for calibrating a tracking array for surgical procedures using a locator, the tracking array having a first tracking surface and a second tracking surface connected to each other, the first tracking surface and the second tracking surface collectively including a plurality of optical tracking elements, the method comprising: positioning the tracking array such that the plurality of optical tracking elements of the first tracking surface and the second tracking surface are visible to the locator; measuring the relative positions of the plurality of optical tracking elements while they are visible to the locator; detecting the orientation of the plurality of optical tracking elements while they are visible to the locator; and grouping the plurality of optical tracking elements into a first rigid body and a second rigid body based on the measured relative positions and orientations of the plurality of optical tracking elements, wherein the first... Each of the rigid body and the second rigid body includes at least one tracking element; the tracking array is positioned such that at least one optical tracking element of the first rigid body and at least one optical tracking element of the second tracking surface are simultaneously visible to the positioner; when at least one optical tracking element of the first tracking surface and at least one optical tracking element of the second tracking surface are visible to the positioner, the relative positions of at least one optical tracking element of the first tracking surface and at least one optical tracking element of the second tracking surface are measured; and a composite rigid body is formed based on the measured relative positions of the first rigid body, the second rigid body, and at least one optical tracking element of the first tracking surface and at least one optical tracking element of the second tracking surface when they are simultaneously visible.

[0125] IV. A method for calibrating a tracking array for surgical procedures using a locator, the tracking array having a first tracking surface and a second tracking surface connected to each other, the first tracking surface and the second tracking surface collectively including a plurality of optical tracking elements, the method comprising: positioning the tracking array such that a plurality of optical tracking elements of the first tracking surface and the second tracking surface are visible to the locator; measuring the relative positions of the plurality of optical tracking elements while they are visible to the locator; positioning the tracking array such that at least one optical tracking element of the first tracking surface and at least one optical tracking element of the second tracking surface are simultaneously visible to the locator; measuring the relative positions of at least one optical tracking element of the first tracking surface and at least one optical tracking element of the second tracking surface while they are simultaneously visible to the locator; and forming a composite rigid body based on the relative positions measured when at least one optical tracking element of the first tracking surface and at least one optical tracking element of the second tracking surface are simultaneously visible to the locator.

[0126] V. A disposable optical tracker for tracking surgical instruments, the optical tracker comprising: a circuit board having a planar configuration; an arrangement of at least three IR-LEDs connected to the circuit board and placed in a common plane, wherein the distance between any two IR-LEDs is unique; circuitry configured to limit the current of the at least three IR-LEDs to no more than 15 mA; a battery electrically connected to the at least three IR-LEDs; and wherein the disposable optical tracker does not include a communication interface and does not include a power cord.

[0127] VI. A disposable optical tracker as described in Clause V, wherein the arrangement of at least three IR-LEDs is configured for continuous or quasi-continuous operation.

[0128] VII. A disposable optical tracker as described in Clause V, wherein the circuitry includes at least one resistor configured to limit the current of at least one of the at least three IR-LEDs.

[0129] VIII. A disposable optical tracker as described in Clause VII, wherein the current of at least one of the at least three IR-LEDs is limited by the internal resistance of at least one of the at least three IR-LEDs and the resistance of at least one resistor that is connected in series with at least one of the at least three IR-LEDs.

[0130] IX. A disposable optical tracker as described in Clause VII, wherein the circuitry is configured to limit the radiant intensity of at least one of the at least three IR-LEDs to no more than 40 microwatts (μW / sr) per steradian.

[0131] X. A disposable optical tracker as described in Clause VII, wherein the distance between two of the at least three IR-LEDs is less than 70 mm.

[0132] XI. A disposable optical tracker as described in Clause VII, wherein the circuitry is configured to operate the at least three IR-LEDs simultaneously.

[0133] XII. A disposable optical tracker as described in Clause VII, wherein the mass of the disposable optical tracker does not exceed 40g.

[0134] XIII. A disposable optical tracker as described in Clause V, wherein the disposable optical tracker further includes a battery socket configured to engage the battery, and wherein the battery is further defined as a coin cell battery.

[0135] XIV. A disposable optical tracker as described in Clause V, wherein the disposable optical tracker further includes a disposable switch electrically connected to the at least three IR-LEDs.

[0136] XV. A surgical navigation system comprising a tracker as described in Clause V and a camera capable of detecting light from at least one IR-LED and generating a camera signal indicating the detected light.

[0137] Several examples have been discussed in the preceding description. However, the examples discussed herein are not intended to be exhaustive or to limit the invention to any particular form. The terminology used is intended to be descriptive rather than restrictive. In light of the foregoing teachings, many modifications and variations are possible, and the invention may be practiced in ways other than those specifically described.

Claims

1. A navigation system for navigating medical devices, the system comprising: Positioner; A tracking array having a first tracking surface and a second tracking surface connected to each other, the first tracking surface and the second tracking surface together comprising a plurality of optical tracking elements; Processor, the processor being configured to: It is determined that the plurality of optical tracking elements of the first tracking surface and the second tracking surface are visible to the positioner; When the plurality of optical tracking elements are visible to the locator, the relative positions of the plurality of optical tracking elements are measured; It is determined that at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner; When at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner, measure the relative position of at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface; as well as A composite rigid body is formed based on the relative positions measured when both the first tracking surface and the second tracking surface are simultaneously visible to the locator.

2. The system as claimed in claim 1, wherein, The processor is further configured to: When the plurality of optical tracking elements are visible to the locator, the orientation of the plurality of optical tracking elements is detected; Based on the measured relative positions and orientations of the plurality of optical tracking elements, the plurality of optical tracking elements are grouped into a first rigid body and a second rigid body, each of the first rigid body and the second rigid body including at least one tracking element; as well as The composite rigid body is formed based on the relative positions of the first rigid body, the second rigid body, and the at least one optical tracking element of the first tracking surface and the at least one optical tracking element of the second tracking surface when they are simultaneously visible to the locator.

3. The system as described in claim 1, wherein, The processor is further configured to: The manufacturing dimensions of the tracking array are stored in the storage device of the navigation system. The manufacturing dimensions include a first set of geometric data, which includes first tracking surface geometric data and second tracking surface geometric data. When the plurality of optical tracking elements are visible to the locator, the orientation of the plurality of optical tracking elements is detected; as well as The tracking array is identified based on the first set of geometric data, the measured relative positions of the plurality of optical tracking elements, and the detected orientation of the plurality of optical tracking elements.

4. The system as claimed in claim 3, wherein: The first tracking surface geometry data includes data indicating the expected relative positions of the plurality of optical tracking elements on the first tracking surface and the expected orientation of the plurality of optical tracking elements on the first tracking surface; as well as The second tracking surface geometry data includes data indicating the expected relative positions of the plurality of optical tracking elements on the second tracking surface and the expected orientation of the plurality of optical tracking elements on the second tracking surface.

5. The system as described in claim 3, wherein, The processor is further configured to cause the display to show calibration instructions based on the step of identifying the tracking array.

6. The system of claim 5, wherein, The calibration command caused by the display includes causing the display to display a graphic instructing the user to rotate the tracking array relative to the locator such that at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the locator.

7. The system of claim 4, wherein, Identifying the tracking array includes comparing the orientation of the detected plurality of optical tracking elements, the expected orientation of the plurality of optical tracking elements on the first tracking surface, and the expected orientation of the plurality of optical tracking elements on the second tracking surface.

8. The system of claim 1, wherein, The processor is further configured to assign the tracking array to the medical device by associating the composite rigid body with the medical device.

9. The system of claim 8, wherein, The processor is further configured to identify the medical device based on associating the composite rigid body with the medical device.

10. The system of claim 1, wherein: The tracking array also includes a third tracking surface; The first tracking surface, the second tracking surface, and the third tracking surface together include the plurality of optical tracking elements; as well as The processor is further configured to: When the plurality of optical tracking elements are visible to the locator, the orientation of the plurality of optical tracking elements is detected; When the plurality of optical tracking elements are visible to the locator, the relative positions of the plurality of optical tracking elements are measured; Based on the measured relative positions and orientations of the plurality of optical tracking elements, the plurality of optical tracking elements are grouped into a first rigid body, a second rigid body, and a third rigid body, each of the first rigid body, the second rigid body, and the third rigid body including at least one tracking element; When at least one optical tracking element of the first tracking surface or at least one optical tracking element of the second tracking surface and at least one optical tracking element of the third tracking surface are visible to the locator, measure the relative position of at least one optical tracking element of the first tracking surface or at least one optical tracking element of the second tracking surface and at least one optical tracking element of the third tracking surface; as well as The composite rigid body is formed based on the relative positions of the first rigid body, the second rigid body, and the third rigid body, as well as the measured relative positions of at least one optical tracking element on the first tracking surface, at least one optical tracking element on the second tracking surface, and at least one optical tracking element on the third tracking surface.

11. A method for calibrating a tracking array for surgical procedures using a locator, the tracking array having a first tracking surface and a second tracking surface connected to each other, the first tracking surface and the second tracking surface collectively including a plurality of optical tracking elements, the method comprising: Position the tracking array such that the plurality of optical tracking elements on the first tracking surface and the second tracking surface are visible to the positioner; When the plurality of optical tracking elements are visible to the locator, the relative positions of the plurality of optical tracking elements are measured; Position the tracking array such that at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner; When at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner, measure the relative position of at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface; as well as A composite rigid body is formed based on the measured relative positions of at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface when they are simultaneously visible to the locator.

12. The method of claim 11, wherein, The method further includes: When the plurality of optical tracking elements are visible to the locator, the orientation of the plurality of optical tracking elements is detected; Based on the measured relative positions and orientations of the plurality of optical tracking elements, the plurality of optical tracking elements are grouped into a first rigid body and a second rigid body, each of the first rigid body and the second rigid body including at least one tracking element; and The composite rigid body is formed based on the relative positions of the first rigid body, the second rigid body, and at least one optical tracking element of the first tracking surface and at least one optical tracking element of the second tracking surface when they are simultaneously visible to the locator.

13. The method of claim 11, wherein, The method further includes: The manufacturing dimensions of the tracking array are stored in the storage device of the navigation system. The manufacturing dimensions include a first set of geometric data, which includes first tracking surface geometric data and second tracking surface geometric data. When the plurality of optical tracking elements are visible to the locator, the orientation of the plurality of optical tracking elements is detected; and The tracking array is identified based on the first set of geometric data, the measured relative positions of the plurality of optical tracking elements, and the detected orientation of the plurality of optical tracking elements.

14. The method of claim 13, wherein: The first tracking surface geometry data includes data indicating the expected relative positions of the plurality of optical tracking elements on the first tracking surface and the expected orientation of the plurality of optical tracking elements on the first tracking surface; as well as The second tracking surface geometry data includes data indicating the expected relative positions of the plurality of optical tracking elements on the second tracking surface and the expected orientation of the plurality of optical tracking elements on the second tracking surface.

15. The method of claim 13, wherein, The method also includes displaying calibration instructions based on the step of identifying the tracking array.

16. The method of claim 15, wherein, The step of displaying calibration instructions further includes displaying a graphic that instructs the user to rotate the tracking array relative to the locator such that at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the locator.

17. The method of claim 15, wherein, The identification step includes comparing the orientation of the detected plurality of optical tracking elements, the expected orientation of the plurality of optical tracking elements on the first tracking surface, and the expected orientation of the plurality of optical tracking elements on the second tracking surface.

18. The method of claim 11, wherein, The method further includes assigning the tracking array to the medical device by associating the composite rigid body with the medical device.

19. The method of claim 18, wherein, The method also includes identifying the medical device by associating the composite rigid body with the medical device.

20. The method of claim 11, wherein: The tracking array also includes a third tracking surface; The first tracking surface, the second tracking surface, and the third tracking surface together include the plurality of optical tracking elements; and The method further includes: When the plurality of optical tracking elements are visible to the locator, the orientation of the plurality of optical tracking elements is detected; When the plurality of optical tracking elements are visible to the locator, the relative positions of the plurality of optical tracking elements are measured; Based on the measured relative positions and orientations of the plurality of optical tracking elements, the plurality of optical tracking elements are grouped into a first rigid body, a second rigid body, and a third rigid body, each of the first rigid body, the second rigid body, and the third rigid body including at least one tracking element; When at least one optical tracking element on the first tracking surface, or at least one optical tracking element on the second tracking surface, and at least one optical tracking element on the third tracking surface are visible to the positioner, measure the relative positions of the at least one optical tracking element on the first tracking surface, or at least one optical tracking element on the second tracking surface, and at least one optical tracking element on the third tracking surface; and The composite rigid body is formed based on the relative positions of the first rigid body, the second rigid body, and the third rigid body, as well as the measured relative positions of at least one optical tracking element on the first tracking surface, at least one optical tracking element on the second tracking surface, and at least one optical tracking element on the third tracking surface.

21. A method for operating a tracker, wherein, The tracker includes a tracker frame and circuitry supported by the tracker frame, wherein the circuitry includes at least one infrared light-emitting diode (IR-LED), and further includes a battery or wireless power receiving device configured to wirelessly receive power. The method includes: Power is supplied by the battery or the wireless power receiving device to operate the at least one infrared light-emitting diode; and The circuit limits the current of at least one of the at least one infrared light-emitting diodes to no more than 15 mA.

22. A method for tracking the position and orientation of a tracker coupled to a surgical instrument within a surgical navigation system, the tracker defining a longitudinal axis and comprising at least three arrays, each of the at least three arrays having at least three infrared emitters, the at least three arrays being arranged radially about the longitudinal axis, the method comprising: The position of each of the at least three infrared emitters is measured to determine the position and orientation of each array; Calculate the correction factor corresponding to the position of at least one marker in each array relative to the other arrays; Determine the relative position and orientation of at least one marker in each array visible to the surgical navigation system; as well as The position and orientation of the tracker are determined by associating the relative position and orientation of at least one marker in each array with the absolute position of the tracker using the correction factor.

23. A method for calibrating a tracking array for surgical procedures using a locator, the tracking array having a first tracking surface and a second tracking surface connected to each other, the first tracking surface and the second tracking surface collectively including a plurality of optical tracking elements, the method comprising: Position the tracking array such that the plurality of optical tracking elements on the first tracking surface and the second tracking surface are visible to the positioner; When the plurality of optical tracking elements are visible to the locator, the relative positions of the plurality of optical tracking elements are measured; When the plurality of optical tracking elements are visible to the locator, the orientation of the plurality of optical tracking elements is detected; Based on the measured relative positions and orientations of the plurality of optical tracking elements, the plurality of optical tracking elements are grouped into a first rigid body and a second rigid body, each of the first rigid body and the second rigid body including at least one tracking element; Position the tracking array such that at least one optical tracking element of the first rigid body and at least one optical tracking element of the second tracking surface are simultaneously visible to the positioner; When at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner, the relative positions of the at least one optical tracking element on the first tracking surface and the at least one optical tracking element on the second tracking surface are measured. as well as A composite rigid body is formed based on the relative positions of the first rigid body, the second rigid body, and the at least one optical tracking element of the first tracking surface and the at least one optical tracking element of the second tracking surface when they are simultaneously visible to the locator.

24. A method for calibrating a tracking array for surgical procedures using a locator, the tracking array having a first tracking surface and a second tracking surface connected to each other, the first tracking surface and the second tracking surface collectively including a plurality of optical tracking elements, the method comprising: Position the tracking array such that the plurality of optical tracking elements on the first tracking surface and the second tracking surface are visible to the positioner; When the plurality of optical tracking elements are visible to the locator, the relative positions of the plurality of optical tracking elements are measured; Position the tracking array such that at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner; When at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner, measure the relative position of at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface; as well as A composite rigid body is formed based on the relative positions of at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface when they are simultaneously visible to the locator.

25. A disposable optical tracker for tracking surgical instruments, the optical tracker comprising: Circuit board with a planar configuration; An arrangement of at least three IR-LEDs is connected to the circuit board and placed in a common plane, wherein the distance between any two IR-LEDs is unique; A circuit configured to limit the current of the at least three IR-LEDs to no more than 15mA; A battery, which is electrically connected to the at least three IR-LEDs; and The disposable optical tracker does not include a communication interface or a power cord.

26. A tracker for a handheld surgical instrument having an instrument axis, the tracker comprising: A tracker frame includes a mounting body defining an instrument engagement hole with a longitudinal axis and including an attachment protrusion projecting parallel to the longitudinal axis and capable of engaging a surgical instrument to constrain the tracker frame in rotation along the instrument axis, wherein the instrument engagement hole is bisected by a plane parallel to the longitudinal axis to define a first region and a second region; and Multiple LED emitters are coupled to the tracker frame and arranged around the longitudinal axis such that a first number of LED emitters are positioned in a first region and a second number of LED emitters are positioned in a second region, the first number being greater than the second number to reduce obstruction to the surgical instrument.

27. A tracker for a handheld surgical instrument, the tracker having a proximal end spaced apart from a distal end along the instrument axis, the tracker comprising: A tracker frame, formed of polymer and defining an instrument engagement hole, the instrument engagement hole defining a longitudinal axis and configured for slidably engaging the surgical instrument such that the longitudinal axis of the instrument engagement hole is aligned with the instrument axis, wherein the tracker frame is non-rotatably fixed to the surgical instrument; and Multiple infrared emitters, electrically connected to a power source and coupled to the tracker frame, wherein the radiation intensity of each of the infrared emitters is less than 40 microwatts (µW / sr) per steradian.

28. A tracker for a handheld surgical instrument, the tracker comprising: A tracker frame including a mounting body defining an instrument engagement hole defining a longitudinal axis, the tracker frame being configured to slidably engage the surgical instrument such that the longitudinal axis of the instrument engagement hole is aligned with the instrument axis. and At least four infrared emitters are each connected to the tracker frame, wherein the at least four infrared emitters are arranged to form a three-dimensional volume, and wherein the three-dimensional volume is a tetrahedron.

29. An optical tracker for a handheld surgical instrument having an instrument axis, the optical tracker comprising: A tracker frame including a mounting body defining an instrument engagement hole defining a longitudinal axis, the tracker frame being configured to slidably engage the surgical instrument such that the longitudinal axis of the instrument engagement hole is aligned with the instrument axis. Multiple optical markers are attached to the tracker frame; The optical tracker defines a first array comprising at least three of the plurality of optical markers, wherein the at least three optical markers define a first region; The optical tracker further defines a second array comprising at least three of the plurality of optical markers, wherein the at least three optical markers define a second region; The optical tracker further defines a third array comprising at least three of the plurality of optical markers, wherein the at least three optical markers define a third region, wherein the third region is equal to the second region; and The first array, the second array, and the third array are arranged to define a tetrahedral shape having an edge and a face intersecting the longitudinal axis, such that the vertices of the tetrahedral shape are spaced apart from the longitudinal axis.

30. A tracking handheld surgical instrument having a body and a flexible power cable, the body extending between a proximal and distal end along an instrument axis, the flexible power cable being coupled to the body and extending from the proximal end and configured to bend away from the handheld surgical instrument at a distance equal to the bending radius of the flexible power cable, the tracking handheld surgical instrument comprising: A tracker frame including a mounting body defining an instrument engagement hole defining a longitudinal axis, the tracker frame being configured to slidably engage the body of a handheld surgical instrument at its proximal end such that the longitudinal axis of the instrument engagement hole is aligned with the instrument axis, wherein three proportionally proportioned radial segments are defined around the longitudinal axis to collectively surround the longitudinal axis, and wherein the proximal end of the tracker frame is proximally spaced from the proximal end of the handheld surgical instrument and positioned relative to the flexible power cable such that contact between the proximal end of the tracker frame and the flexible power cable is minimized; and At least six optical markers are attached to the tracker frame and positioned such that at least one of the at least six optical markers is positioned in each radial segment, and at least two of the at least six optical markers are positioned proximally at the proximal end of the handheld surgical instrument.

31. An optical tracker for surgical instruments, the optical tracker comprising: A tracker frame including a mounting body defining an instrument engagement hole defining a longitudinal axis, the tracker frame being configured for attachment to the surgical instrument such that the longitudinal axis is aligned with the instrument axis; At least nine optical markers are coupled to the tracker frame and arranged to form at least three arrays, wherein each array includes at least three of the at least nine optical markers, and wherein the at least three optical markers in each array are configured to emit light in the same direction; A disposable switch and battery electrically connected to the at least nine optical markers; and Each of the at least three arrays is oriented to emit light in a different direction from each other.

32. A method for calibrating a tracking array for surgical procedures using a locator, the tracking array having a first tracking surface and a second tracking surface connected to each other, the first tracking surface and the second tracking surface collectively including a plurality of optical tracking elements, the method comprising: Position the tracking array such that the plurality of optical tracking elements on the first tracking surface and the second tracking surface are visible to the positioner; When the plurality of optical tracking elements are visible to the locator, the relative positions of the plurality of optical tracking elements are measured; When the plurality of optical tracking elements are visible to the locator, the orientation of the plurality of optical tracking elements is detected; Based on the measured relative positions and orientations of the plurality of optical tracking elements, the plurality of optical tracking elements are grouped into a first rigid body and a second rigid body, each of the first rigid body and the second rigid body including at least one tracking element; Position the tracking array such that at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner; When at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner, measure the relative position of at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface; as well as A composite rigid body is formed based on the relative positions of the first rigid body, the second rigid body, and the at least one optical tracking element of the first tracking surface and the at least one optical tracking element of the second tracking surface when they are simultaneously visible to the locator.

33. A system for navigating a medical device, the system comprising: Positioner; A tracking array having a first tracking surface and a second tracking surface connected to each other, the first tracking surface and the second tracking surface together comprising a plurality of optical tracking elements; Processor, the processor being configured to: When the plurality of optical tracking elements are visible to the locator, the relative positions of the plurality of optical tracking elements are measured; When the plurality of optical tracking elements are visible to the locator, the orientation of the plurality of optical tracking elements is detected; Based on the measured relative positions and orientations of the plurality of optical tracking elements, the plurality of optical tracking elements are grouped into a first rigid body and a second rigid body, each of the first rigid body and the second rigid body including at least one tracking element; When at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner, measure the relative position of at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface; as well as A composite rigid body is formed based on the relative positions of the first rigid body, the second rigid body, and the at least one optical tracking element of the first tracking surface and the at least one optical tracking element of the second tracking surface when they are simultaneously visible to the locator.

34. A method for calibrating a tracking array for surgical procedures using a locator, the tracking array having a first tracking surface and a second tracking surface interconnected with each other, the first tracking surface and the second tracking surface collectively comprising a plurality of optical tracking elements, the method comprising: Position the tracking array such that the plurality of optical tracking elements on the first tracking surface and the second tracking surface are visible to the positioner; When the plurality of optical tracking elements are visible to the locator, the relative positions of the plurality of optical tracking elements are measured; Position the tracking array such that at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner; When at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface are simultaneously visible to the positioner, measure the relative position of at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface; as well as A composite rigid body is formed based on the measured relative positions of at least one optical tracking element on the first tracking surface and at least one optical tracking element on the second tracking surface when they are simultaneously visible to the locator.

35. An optical tracker for surgical instruments, the optical tracker comprising: A tracker frame, the tracker frame including a mounting body configured to be coupled to the surgical instrument, the tracker frame being made of a polymer; At least six optical markers are coupled to the tracker frame and arranged to form at least two arrays, wherein each array includes at least three of the at least six optical markers, and wherein the at least three optical markers in each array are configured to emit light in the same direction; A battery electrically connected to the at least six optical markers; and Each of the at least three arrays is oriented to emit light in a different direction from each other.

36. An optical tracker for surgical instruments, the optical tracker comprising: A tracker frame including a mounting body defining an instrument engagement hole defining a longitudinal axis, the tracker frame being configured for attachment to the surgical instrument such that the longitudinal axis is aligned with the instrument axis; At least nine optical markers are coupled to the tracker frame and arranged to form at least three arrays, wherein each array includes at least three of the at least nine optical markers, and wherein the at least three optical markers in each array are configured to emit light in the same direction; Each of the at least three arrays is oriented to emit light in a direction different from each other; and Two of the at least three arrays are configured such that the positions of the at least three optical markers are mirror images of the longitudinal axis.

37. An optical tracker for surgical instruments, the optical tracker comprising: A tracker frame, the tracker frame including a first portion and a second portion defining an instrument engagement, and the tracker frame further including a polymer; A first circuit board is coupled to a first portion of the tracker frame and includes at least three LEDs defining a first array; A second circuit board is attached to a second portion of the tracker frame and includes at least three LEDs defining a second array; The first array is oriented to emit light in a direction different from that of the second array; A battery, which is electrically connected to the first circuit board and the second circuit board; and The optical tracker does not have a communication interface.

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