Surgical instrument tracker

Abstract

We provide an optical tracker that can be used with handheld surgical instruments. [Solution] The optical tracker comprises a tracker frame, which includes a mounting body defining an instrument engagement opening having a longitudinal axis, and an offset body projecting proximal to the mounting body. The instrument engagement opening is configured to receive the proximal region of a surgical instrument so that the longitudinal axis of the tracker is aligned with the axis of the surgical instrument. Three radial portions of equal proportions define the longitudinal axis and collectively surround it. The tracker further comprises at least six markers, which are arranged to form at least two arrays coupled to the tracker frame, and are positioned so that at least one marker is positioned within each radial portion. A portion of each array is coupled to the offset body and positioned proximal to the mounting body.

Description

Technical Field

[0001] This application claims priority to U.S. Provisional Patent Application No. 62 / 906,629, filed on September 26, 2019, the entire content of which is incorporated herein by reference.

Background Art

[0002] During surgery, surgeons often need to use instruments that need to be inserted into the patient's body. When the instrument enters the patient's body, the tip of the instrument becomes invisible to the surgeon. In such cases, to assist the surgeon in navigating the instrument, a surgical navigation system can be used to track the instrument and provide visual or acoustic guidance to the surgeon.

[0003] One way to track an instrument is to attach a tracker to the instrument. The cameras in the operating room detect the tracker and generate data that is used to calculate the position of the tracker and thus the position of the instrument. Usually, the patient is also tracked, allowing the position of the instrument relative to the patient to be calculated.

Summary of the Invention

[0004] Further improvements to trackers are desired.

[0005] The advantages of the present disclosure will become better understood by referring to the following detailed description in conjunction with the accompanying drawings, as will be readily appreciated.

Brief Description of the Drawings

[0006] [Figure 1] FIG. is a diagram showing an exemplary surgical facility showing a surgical navigation system. [Figure 2] ​​​​​​​​This is a diagram illustrating the first embodiment of the tracker and the environment of the surgical instrument being held by the user. [Figure 3] Figure 2 is a perspective view of a tracker, which has a tracker frame attached to a surgical instrument, with three radial sections arranged around the longitudinal axis of the tracker. [Figure 4] Another perspective view of the tracker in Figure 2, showing the tracker frame attached to the surgical instrument. [Figure 5] Figure 2 is a side view of the tracker, showing the tetrahedron shape of the tracker frame and the two lines of sight between the tracker and the surgical instruments. [Figure 6] Figure 2 is a top view of the tracker and surgical instrument, showing the marker array and area. [Figure 7] Figure 2 shows a proximal view of the tracker and surgical instrument, illustrating the three radial sections, the first and second regions, and the emission patterns of several markers. [Figure 8] Figure 2 is a perspective view of the tracker, showing the tetrahedron shape of the tracker frame, the marker array, and the region. [Figure 9] Figure 2 is a perspective view of the tracker, showing the device engagement opening and the relief area. [Figure 10] The device engagement opening and retaining assembly are shown. This is a distal perspective view of the tracker in Figure 2. [Figure 11] Figure 2 is an exploded view of the tracker, showing the inside of the tracker frame and marker array. [Figure 12] This is a perspective view of another embodiment of the tracker, showing it being coupled to a surgical instrument. [Figure 13] Figure 12 is another perspective view of the tracker. [Figure 14] Figure 12 is a side view of the tracker. [Figure 15] Figure 12 is a top view of the tracker. [Figure 16] Figure 12 is a proximal view of the tracker. [Figure 17] This is a perspective view of yet another embodiment of the tracker, showing it coupled to a surgical instrument. [Figure 18] Another perspective view of the tracker of FIG. 17. [Figure 19] A side view of the tracker of FIG. 17. [Figure 20] A top view of the tracker of FIG. 17. [Figure 21] A proximal view of the tracker of FIG. 17. [Figure 22] A perspective view of another embodiment of the tracker. [Figure 23] A perspective view of the tracker of FIG. 22. [Figure 24] A proximal view of the tracker of FIG. 22. [Figure 25] A side view of the tracker of FIG. 22 coupled to a surgical instrument. [Figure 26] A perspective view of the tracker and a surgical navigation cart.

BEST MODE FOR CARRYING OUT THE INVENTION

[0007] Referring to the drawings, in which like numerals indicate like parts throughout several views, the present disclosure includes a tracker 100 for a handheld surgical instrument 34, a surgical navigation system 12, and a method for operating the tracker 100. FIG. 1 shows an exemplary surgical system 10 comprising a surgical navigation system 12 for tracking one or more surgical instrument assemblies 30 including a surgical instrument 34 and a tracker 100 to assist a medical professional, such as a surgeon, in performing a medical procedure.

[0008] The surgical navigation system 12 can comprise a navigation interface including one or more display units 14 and one or more user inputs 16. The display unit 14 of the surgical navigation system 12 can display various prompts and data . It may be configured to display a terminal entry box. For example, the display unit 14 is external A text box that allows doctors to manually enter or select the type of surgical procedure they will perform. It may be configured to display a message or prompt. The display unit 14 displays the preoperative image Alternatively, it may be configured to display patient data such as scans. As mentioned above, Preoperative images are obtained from MRI scans, radiographs, or computer scans of the patient's anatomical structure. This can be based on tomography (CT) scans. Preoperative images are used in surgical navigation systems. It can be uploaded to stem 12 and displayed on display unit 14. T14 displays the surgical plan for the medical procedure, overlaid on the patient's data or image. It may be further configured to include a surgical route for performing medical procedures, or medical This may include the planned trajectory or orientation of medical instruments during treatment. The image shows the position and / or orientation of implants or medical devices inserted during a medical procedure, according to the patient's perspective. This may also include overlaying data or images. Surgical Navigation System 1 2 refers to the planned surgical route for performing medical procedures, or the medical instruments used during medical procedures. Configured to display and / or project a holographic image of a specific orbit or orientation. It is conceivable that a display unit 14 may be provided. This is to show the surgical route to the patient or It may also include projecting onto other surfaces within the operating room. Project the surgical route onto a head unit, such as the lens, shield, or glasses of a head unit. This may also include: displaying the target trajectory and / or target position, surgically. An exemplary configuration of a surgical navigation system 12, which includes a display unit worn by a physician, is: The entire International Patent Application No. PCT / IB2018 / is incorporated herein by reference. It is disclosed in document number 053130.

[0009] User input 16 allows the surgeon to enter patient data or modify the surgical plan. It may be configured to allow this. Patient data may include preoperative images of the patient's anatomical structure. Images may be included. These images may be MRI scans of the patient's anatomical structures, radiation. It can be based on a line scan or computed tomography (CT) scan. The data includes the type of medical procedure being performed, the patient's anatomical characteristics, the patient's specific medical condition, and Includes additional information related to operational settings for and / or surgical navigation settings. It is also possible. For example, when performing spinal surgery, the surgeon can use user input 16 to perform medical procedures. Information related to the specific vertebra being treated can be entered. The surgeon can input information about the vertebra, and / or relating to the size and shape of medical devices or implants inserted during medical procedures. Various anatomical dimensions can also be entered. User input 16 is for the surgeon to input patient data. It may be configured so that it can be selected, edited, or manipulated. For example, a surgeon This allows for the identification and / or selection of anatomical features from patient data. Select the surgical site, such as choosing the vertebra and / or a specific area on the vertebra to be treated. It may include doing so.

[0010] The surgical navigation system 12 further includes a navigation processor 18. This is possible. The navigation processor 18 is a personal computer or laptop. It can be located on the top computer. The navigation processor 18 is used by the user Input 16, display unit 14, central processing unit (CPU) and / or other processor, It can communicate with memory (not shown) and storage (not shown). Navigation The suction processor 18 is related to the operation of the surgical navigation system 12, as specified herein. Software for implementing the various routines and / or methods disclosed in It may further include / or operation instructions. The software and / or operation instructions are Find the precise position and / or angular alignment of the surgical instruments 34 related to patient 20. The navigation processor 18 may include a planning system configured to do so. The surgical instrument assembly 30 can be connected directly or indirectly via wired or wireless communication. .

[0011] The surgical navigation system 12 includes a tracking unit containing one or more sensors 24. It can also have 22 or a localizer. The sensor is a CCD camera, CMOS camera. Cameras such as optical imaging cameras, magnetic sensors, radio frequency sensors, and Alternatively, the tracking device 100 detects and / or senses the position of the surgical instrument assembly 30. It may include any other sensors that are compatible with it. The localizer 22 has multiple marks It can detect radiation or light from K128, and a row representing the detected radiation or light. It can generate a colorizer signal. An exemplary surgical navigation system 12 is a ma It may be configured to utilize trackers 100 that have a fixed spatial relationship between the trackers 128. The descriptions of various appropriate localizers that may be available are incorporated herein by reference in their entirety. It is found in U.S. Patent No. 10,531,926 (B2).

[0012] The processor 18 may be capable of receiving localizer signals. The tracker 100 may be able to be matched and tracked based on the received sensor signal. The processor, based on the localizer signal, determines the tracker 100 for localizer 22. The orientation and / or position can also be calculated. The processor 18 performs operations related to spatial relationships. It is possible to access the information captured by the stereo camera. The original image is not needed, and the camera only needs to contain a single 2D image sensor.

[0013] The processor 18 processes information about the patient's body 20 (for example, computed tomography images of the patient's body). Further configured to receive and / or store shadow scan and / or tracking signals. It may be done. Next, the processor 18 determines the position of the surgical instrument 34 relative to the patient's body 20 and / or the orientation can be calculated. The processor 18 provides a visual indicator showing the tracking of the surgical instrument 34. It may be configured to generate visual or acoustic signals. Visual signals are displayed on the display unit. It may be shown. The processor 18 is a computing device separate from the localizer. It may be part of it. Alternatively, the localizer may include a processor.

[0014] Figure 2 is a perspective view of the first configuration of the tracker 100 and surgical instrument 34. Surgical instrument 3 4 has a proximal end 36 and a distal end 38 spaced apart along the instrument axis 40. As shown in Figure 2. In many cases, the surgical instrument 34 has a source (for example, a motor) located near the proximal end 36. Alternatively, an attachment connected to the distal end 38 of the surgical instrument 34 (from an ultrasonic transducer) Mechanical energy is transmitted to the ment 42 along the instrument shaft 40. An example of this arrangement is shown in Figure 2. As shown in Figure 7, surgical instrument 34 is shown as a high-speed drill. Here, surgical instrument 34 This includes a housing 46, a motor (not shown) located inside the housing 46, and a proximal region. A flexible supply cable 48 protruding from the housing 46, and the distal end of the surgical instrument 34. It can include nearly 38 attachment interfaces 50. Exemplary surgical instrument This refers to U.S. Patent No. 8,597,316 and U.S. Patent No. 8,597,316, which are incorporated herein by reference. This can be seen in National Patent Application Publication No. 2017 / 0319217.

[0015] The Tracker 100 can operate with surgical instruments 34 and surgical navigation systems. Yes, it determines the position and / or orientation of the surgical instrument 34 in the operating room. To precisely determine the position of 4, the tracker 100 is attached to the surgical instrument 34, and the surgical procedure It is configured to prevent their relative movement. In addition, the Tracker 100 is a surgical navigation system. To maximize the visibility of the Tracker 100 using the ergonomic system, it is connected to the surgical instrument 34. It should be combined.

[0016] Throughout the drawing, surgical instrument 34 is shown as a high-speed drill, but tracker 100 It can be used with surgical instruments 34 other than high-speed drills. For example, tracker 10 0 is a handheld ultrasound ablation tool or biopsy needle, or a robotic end-f It may be coupled to a part of a robotic device such as an ejector. Similarly, the Tracker 100 is handheld. It is configured to be attached to other surgical instruments (not shown), such as a drill, saw, or bur. Good. Similarly here, the attachment 42 connected to the distal end 38 of the surgical instrument 34 is In Figure 2, an inclined attack that drives the rotary tool on an axis (not shown) different from the tool axis 40. It is shown as an attachment. For example, even if the attachment is straight, 15 It can be tilted at degrees such as 45 degrees, and attachments can be 30mm, 50mm, etc. They can be of any length.

[0017] Surgical instruments are small in mass and can be structurally weak. Such handheld surgical instruments 34 When a heavy tracker is attached, the tracker 100 shifts its center of gravity, (for example, The torque applied to the hand holding the instrument can cause fatigue. Furthermore, the surgical instrument 34 can be removed. The weight of the attached heavy Tracker 100 causes it to deform (elastically or plastically), and furthermore It can be damaged. The Tracker 100 shown throughout the drawings is typically lightweight. Therefore, the above-mentioned drawbacks are reduced or eliminated. The handheld surgical instrument 34 is held in the hand. It is less tiring to hold, and the Tracker 100 is less likely to deform due to its weight. obtain.

[0018] To facilitate the detachable attachment of the tracker 100 to the surgical instrument 34, Tracker 100 comprises a tracker frame 102 including a mounting body 104, and the mounting body 104 is A fixture engagement opening 106 is defined that penetrates along the longitudinal axis 108. Further details are provided below. As explained below, the fixture engagement opening 106 is located on the longitudinal axis 1 of the mounting body 104, where the fixture shaft 40 is located. It is configured to receive the surgical instrument 34 so that it is aligned with 08. In other words, The mounting body 104 may be concentric with the main body of the surgical instrument 34. The tracker frame 102 is an offset body supported by the mounting body 104 and extending proximal to the longitudinal axis 108 substantially parallel to it. It may further include 110. The offset body 110 is substantially perpendicular to the longitudinal axis 108. A notch 118 that penetrates in the direction can be defined. The tracker frame 102 is made of titanium. Metals such as cellulose, polymers such as nylon, or epoxy resins such as aromatic epoxyamine resins It can contain resin. The tracker frame is suitable for use in medical settings and can be any other Including the materials, it is possible to provide the rigid structure required for Tracker 100. Tracker Frame The frame may be composed of polymers and may be manufactured using additive manufacturing techniques.

[0019] Alternatively, the tracker 100 and surgical instrument 34 are mechanically connected for single use. It is also possible that the tracker 100 and the surgical instrument 34 are integrally formed (for example, during injection molding). The tracker 100 may be formed integrally with, for example, the handle of the surgical instrument 34. Good. Since Tracker 100 is already attached to instrument 34, the surgeon can use Tracker 1 The surgical instrument 34 can be used immediately without needing to attach 00 to the surgical instrument 34. The surgeon shall dispose of both the Tracker 100 and the surgical instrument 34 after a single use. It is possible.

[0020] To track the position and orientation of the surgical instrument 34, the tracker 100 is optionally equipped with 1 Arranged in one or more arrays 162, 164, 166 and tracker frame 102 It comprises multiple markers 128 coupled to each other. Tracker frame 102 has each radiation It can have three sides aligned to the shaped portions 112, 114, and 116, respectively. Each side is oriented at approximately 120 degrees from the other side. Multiple arrays 162, 164, 166 are each a Rays 162, 164, and 166 are positioned on one of the three sides, facing in different directions from each other. They are positioned to face each other. The first array 162 is aligned with the first radial portion 112. The second array 164 is positioned on the side and is aligned with the second radial portion 114. The third array 166 is positioned on the side and aligned with the third radial portion 116. It is positioned on the side. The side aligned with the first radial portion 112 is offset body 1 It is positioned on 10. The offset body 110 and the mounting body 104 cooperate to produce the second radiation. This defines two sides that are aligned with the shaped portion 114 and the third radial portion 116. Other array numbers and / or side numbers are also possible.

[0021] Each side has a specific radial arrangement, but the angle of the side is such that the side slopes toward a common vertex. It may be configured to converge at an oblique angle, beyond the proximal end 152 of the offset body 110. The offset body 110 and / or the first array 162 are such that the offset body 110 is obliquely oriented. The oblique axis can be defined so as to protrude from the mounting body 104 along the oblique axis. Three equally proportioned diagonal sections (similar to the radial sections described herein) centered on It can be further defined as follows: Here, at least six markers 128 are located along the longitudinal axis. At least three markers 128 are arranged radially around the oblique axis. And, positioned on the offset body 110, of these at least three markers 128 One of these is located in each of the three slanted sections, spaced apart from the longitudinal axis 108, and is a flexible supply cable. It is designed to provide space for a 48-inch cable.

[0022] One way to improve the accuracy of the surgical navigation system is to improve the visibility of the Tracker 100. This includes maximizing recognition. The accuracy of the Tracker 100 can be improved in several ways. Yes, it is possible. For example, the size of tracker 100 can be increased, and the number of markers 128 can be increased. It can be increased, the brightness of marker 128 can be increased, and there are other methods as well. However, these methods increase the size and / or mass of the Tracker 100. This can happen; for example, increasing the brightness of marker 128 will consume power. This shortens the period during which the Tracker 100 can be operated, or the battery The weight increases as the capacity increases.

[0023] The visibility of the Tracker 100 is enhanced by the strategic placement of markers 128 on the Tracker frame 102. It can also be enhanced by doing so. As best shown in Figures 3 and 7, three radiation The projectile portions 112, 114, and 116 are defined around the longitudinal axis 108. The shaped parts 112, 114, and 116 are the respective parts of the tracker 100 and the tracker 10 It has a volume corresponding to the arrangement of the constituent elements of 0. As shown in the figure, the first radial portion 112 is The offset body 110 may be defined in approximate alignment with the second radial portion 114. The third radial portion 116 crosses the longitudinal axis 108 on the opposite side of the offset body 110. They are then aligned. For example, as shown in Figure 3, each radial portion 112, 114, 116 It extends 120 degrees around tracker 100. Radial portions 112, 114, and 116 are 3 It is specified that all of the sizes are equal.

[0024] In some configurations, the tracker 100 has the first configuration shown in Figures 2 to 11, and Figure 1 The main body shell 120 can be provided with a second configuration as shown in Figures 2 to 16. 120 covers a portion of the tracker frame 102, and inside the tracker frame 102 122 and surrounding the outer 124 (see Figure 11). As will be explained in more detail below, the tracker One of the components 100 may be placed inside 122 of the tracker frame 102. The shell 120 may be made of polymer material, titanium, or other suitable material. The lacquer frame 102 has separate mounting bodies 104 and / or offset bodies 110. To avoid this, it may be a single or integrated structure. Tracker frame 102 and main body A suitable manufacturing process for forming the shell 120 is, in particular, injection molding, additive manufacturing (3D). Printing, computer numerical control (CNC) machining, polymer casting, vacuum forming, and It may include raw molding.

[0025] The tube guide 126 is specified on the tracker frame 102 of the mounting body 104, for surgical use The tube guide 126 may be configured to receive the perfusion tube 52. Accept tube 52 and route the perfusion tube 52 neatly around the tracker frame 102. And, so as not to interfere with the surgeon, the irrigation tube tracks the cuff in an unpredictable way. Ensure it does not interfere with the frame. The Tracker 100 accepts perfusion tubes 52 of different diameters. It may be equipped with two tube guides 126 that can be configured to insert these. The tube guide 126 allows for the insertion of multiple sizes of perfusion tubes 52, even if they are of the same size. They may be of different sizes to accommodate them. As shown in Figure 2, tube guide 126 The irrigation tube is positioned so that when it is in contact with the surgical instrument 34, it is approximately parallel to the longitudinal axis 108. The 52 is configured to be bent and pointed at approximately a 90-degree angle. The tube guide is for tracker and suction. It is configured to serve as a guide for other elongated components, such as wires that supply power to the tube. It may also be used.

[0026] As seen in the perspective view shown in Figure 8, the tracker frame 102 has radial portions 112, 114 The arrangement of the three sides aligned to 116 gives it a roughly tetrahedral shape. Yes, it is possible. Each of these sides forms one of the four faces of the tetrahedron 154, and each side The edges are defined at the intersections. The fourth face of the tetrahedron is the distally facing face 184 of the mounting body 104. Thus it is formed. This distally facing surface 184 is approximately perpendicular to the longitudinal axis 108, and the vessel A portion of the engagement opening 106 is defined. The distally facing surface 184 is the proximal part of the mounting body 104. It is positioned on the opposite side of the facing surface 185. Distal facing surface 184 and proximal facing surface 18 5 generally forms the distal and proximal ends of the mounting body 104, respectively. The tetrahedral shape is , as a regular tetrahedron with all four faces being the same size, or with some faces being of different sizes, It may be realized as an irregular tetrahedron with elements touching at different angles.

[0027] In some embodiments, the tracker 100 has four meters for tracking the surgical instrument 34. It may be provided with only marker 128. In these embodiments, each of the marker 128 These are connected to the tracker frame 102 and positioned at the vertices of the tetrahedron shape. Each marker 12 8 forms an array with two other markers 128 that are visible to the navigation system. Each marker 128 maximizes the emission of radial light centered on the longitudinal axis 108. Therefore, it can face a different direction than the other markers 128.

[0028] As mentioned above, the offset body 110 is supported by the mounting body 104 and extends in the proximal direction. The offset body 110 has a distal end 150 connected to the mounting body 104, and a distal surface It extends adjacent to 184 to the proximal end 152. The length 156 of the offset body 110 is distal The distance defined between end 150 and proximal end 152, where the proximal end 152 is separated from the mounting body 104 It corresponds to separation. The proximal end 152 is a tetrahedron 15 defined by the tracker frame 102. It is adjacent to one vertex of 4. As best shown in Figures 6, 8, and 10, the offset The T-body 110 is tapered from the distal end 150 to the proximal end 152, in other words, proximal End 152 has a smaller contour than distal end 150.

[0029] Furthermore, as mentioned above, the offset body 110 is generally positioned in the first radial portion 112. Furthermore, as best shown in Figure 5, it is spaced 158 units away from the longitudinal axis 108. The proximal end 152 has a smaller contour and the proximal end 152 is separated at a height 158. As a result, the tracker frame 102 is connected to the flexible supply cable 48 of the surgical instrument 34. A relief area 160 is provided. As best shown in the side view of Figure 5, the relief area 160 is generally located around the flexible supply cable 48, and the flexible supply cable 48 and Minimize the possibility of contact with the lacquer frame 102. For example, surgeons and other medical professionals. If you use a pencil grip with surgical instrument 34 in the same way as shown in Figure 2, In this case, the flexible supply cable 48 generally curves toward the floor and away from the surgeon. Since the supply cable 48 has mass, force is applied to the proximal end 36 of the surgical instrument 34, This moment is centered on the point where the surgeon is holding the surgical instrument 34. As the instrument 34 moves, the surgeon engages the flexible supply cable 48 which naturally follows this movement. You often get used to the force that connects to it. If the flexible supply cable 48 unexpectedly comes into contact with something, your hand The balance of surgical instrument 34 is affected. If the balance of instrument 34 is not constant, the surgeon's precision The movement may be affected, which may result in the distal end 38 of the surgical instrument 34 Undesirable movement may occur. A large relief area below the offset body 110. By providing 160, the surgeon can connect the flexible supply cable 48 to the tracker frame 10 To move the surgical instrument 34 confidently through a wide range of motion while reducing the possibility of contact with 2. This is possible. The relief area 160 is where the flexible supply cable 48 is located, and the tracker frame 102 Without contact, with a small bending radius (i.e., at a large angle with respect to the instrument axis 40) It provides a gap for free curvature.

[0030] In addition to reducing the mass of the Tracker 100, it also improves the surgeon's visibility of the surgical site. It is desirable to reduce any interference. In some cases, the surgeon may, schematically as shown in Figure 5. As shown, it may be desirable to view the surgical site along a line of sight 188 that is roughly aligned with the instrument axis 40. When a large tracker is used with surgical instrument 34, the tracker obstructs the surgeon's view. Or, if the surgeon needs to grasp the surgical instrument 34 in a less desirable way, This can result in a larger angle from the longitudinal axis from which the surgeon views the surgical site. The angle of line 188 is the length of the surgical instrument 34 and the offset body 110 from the longitudinal axis 108. It is affected by both the height of 158 and the angle of view of 188. Therefore, it is desirable to reduce the height of the offset body 110, which is 158. However, The proximal end 152 of the offset body 110 extends proximally from the distal end 150 of the offset body 110. The distance (i.e., length 156) is the distance at which the offset body 110 is separated from the longitudinal axis 108. Since it is greater than the distance (i.e., height 158), the regions of each array 162, 164, and 166 are It remains the maximum, thereby maximizing the accuracy of the Tracker 100. Offset By reducing the body height of 110 to 158, the angle of the line of sight (188) can be reduced to less than 40 degrees. This is possible. Depending on the attachment 42 connected to the surgical instrument 34, the line of sight can be less than 30 degrees. , or can be further reduced to less than 20 degrees. In some configurations, Any part of the Tracker 100 is not within 1, 2, 3, or 4 cm of the longitudinal axis. It's not extended beyond the boundary.

[0031] As mentioned above, the tracker 100 is aligned with the instrument axis 40 and the longitudinal axis 108. The surgical instrument 34 is connected to the surgical instrument 34 via the instrument engagement opening 106. Precise positioning is facilitated by the clear relationship between the tracker 100 and the surgical instrument 34. Therefore, these connections should be removable yet securely fixed. As shown in Figures 4 and 9, the tracker 100 inserts the surgical instrument 34 into the instrument engagement opening 10 The system may further include a retaining assembly 132 configured to be fixed within 6. The holding assembly 132 tracks specific surgical instruments 34 and tracker frame 102. Depending on the structure, it can be implemented in several different ways. Specifically, some retaining assemblies Ri 132 may be more suitable for tracker frame 102 including a metal structure, and others The retaining assembly 132 may be more suitable for the polymer structure. The fit is heavy Depending on the physical characteristics of the surgical instrument 34, such as its volume or diameter, or in some cases, the tracker The cost is partially determined by factors such as whether the 100 units are single-use disposable or durable. It is possible. In some cases, the Tracker 100 is compatible with a wide variety of surgical instruments 34. To enhance this, multiple retaining assemblies 132 may be provided.

[0032] The housing 46 of the surgical instrument 34 is slidably engaged with the tracker frame 102, Securely connect the tracker 100 and the surgical instrument 34. More specifically, connect the instrument shaft 40 and the longitudinal Align with the directional axis 108, and place the distal end of the surgical instrument 34 on the proximal side of the instrument engagement opening 106. This is done by inserting 38.

[0033] A first alternative to the retaining assembly 132 is the friction clamp best shown in Figures 8 and 10. This is implemented as part 134. Here, the clamp channel 138 is defined on the mounting body 104. It penetrates the mounting body 104. Two elastic arms 140A and 140B are clamped. Arranged within the flannel 138, each elastic arm 140A, 140B has a reference end 142A, 142 It has B and movable ends 144A, 144B. The reference ends 142A, 142B are both C The lamp channel 138 is coupled to the mounting body 104 on one side, and the clamp channel 138 is connected to the navel It extends to the respective movable ends 144A and 144B. The device engagement is best shown in Figure 10. The opening 106 is positioned to align with the elastic arms 140A and 140B. As a result, during use, the elastic arms 140A and 140B are attached to the housing 46 of the surgical instrument 34. It becomes possible to make contact with both sides. Each elastic arm 140A, 140B has a movable end 144 Near A and 144B, there are overlapping portions 146A and 146B having a small width. The overlapping portion 146A of the distal elastic arm 140A has a small width in the distal direction, and the proximal elastic arm The overlapping portion 146B of section 140B has a smaller width in the proximal direction. Overlapping portion 146A, Due to the small width of 146B, each elastic arm 140A, 140B has a movable end 144A , greater than when 144B is in contact, and here exceeding 180 degrees, surgical instrument 34 It can wrap around the housing 46.

[0034] Here, in order to securely connect the surgical instrument 34 and the tracker 100, the instrument engagement opening 1 The diameter of 06 is smaller than the diameter of housing 46. Housing 46 slides against mounting body 104. When movably engaged, the movable ends 144A and 144B of the elastic arms 140A and 140B spread apart. Therefore, the diameter of the fixture engagement opening 106 is increased to match the housing 46. The elastic arms 140A and 140B apply a clamping force to the housing 46 through force. Due to friction and contact between the sex arms 140A, 140B and the housing 46, the tracker 100 is securely held by the surgical instrument 34.

[0035] In addition to the elastic arms 140A and 140B, the retaining assembly is best shown in Figure 9. The device may further include a mounting projection 148 located proximal to the device engagement opening 106. The exemplary mounting projections 148 are arranged radially around the longitudinal axis 108, and the device axis 4 It is configured to index and engage with the surgical instrument 34 along the 0. Specifically, the mounting projection 14 8 engages with the complementary recess of the housing 46 of the surgical instrument 34, and the tracker frame 1 02 is determined and positioned so that it can rotate around the instrument shaft 40. Here, the mounting projection 14 8 has a substantially rectangular contour that is adjacent to the fixture engagement opening 106 and positioned asymmetrically. Therefore, complete engagement between the surgical instrument 34 and the tracker 100 can be achieved in only one position. The indexing engagement between the surgical instrument 34 and the tracker 100 is performed by one or more mounting protrusions. This can be done by using the start 148, thereby ensuring that the tracker 100 is securely connected. This can provide redundancy or additional retention for that purpose.

[0036] A second alternative for the retaining assembly 132 is shown in Figures 12-16 and 17-21. This will be implemented as a cam lock 136' and 136".

[0037] As mentioned above, Tracker 100 is a combination of multiple elements attached to Tracker Frame 102 It can be equipped with multiple markers 128 positioned at I162, 164, and 166. Figure 3 Figures 7 and 11 show that multiple markers 128 are used as at least six markers 128. The tracker 100 may be configured as specified below. Figure 7 shows at least Also, at least one of the six markers 128 is in each radial portion 112, 114, 116 This indicates that it is positioned on the tracker frame 102. In other words, each radiation The shaped portions 112, 114, and 116 include one of the markers 128, and the radial portion 112 Some of 114 and 116 may have multiple markers 128.

[0038] The aforementioned Tracker 100 has at least 6 markers 128, but a larger number of markers The CA128 may be preferable in some cases. For example, the Tracker 100 is for higher 3D accuracy. It can be equipped with nine markers 128. By reducing the number of markers 128, The power consumption of the Rakka 100 can be reduced, which is due to the limitations of degrees of freedom (such as 5 degrees of freedom). Movements, or, for example, in a tracker 100 for tracking a surgical instrument 34, There are cases where this is not possible. Tracker 100 has more than 10 markers 128 to increase redundancy. It can be equipped. Alternatively, the tracker minimizes energy consumption and the line of sight. To increase the size and maintain tracking accuracy, use just 9, 10, 11, or 12 ma It can have markers. Or, furthermore, the tracker can have more than 12 markers. It is possible.

[0039] In addition to the above arrangement of markers 128 in each of the radial portions 112, 114, and 116 Alternatively, the Tracker 100 has multiple markers 128 on the Tracker frame 102 They are connected and configured to be arranged asymmetrically radially with respect to the longitudinal axis 108. It may also be the case that Figures 5 and 7 are parallel to the longitudinal axis 108 and the device engagement opening 10 A longitudinal plane 168 that bisects 6 to define the first region 170 and the second region 172. The edges are shown. The placement of marker 128 is with respect to the first region 170 and the second region 172. Further defined: A first number of markers 128 are positioned in the first region 170. Multiple markers 128 of the second number are positioned in the second region 172, and the first number is the second number It is larger than that. For example, one configuration of Tracker 100 has nine markers 128. And the seven markers 128 of the first number are within the first region 170 or the longitudinal plane 168 It may be positioned on the tracker frame 102 so as to be above, and two of the second number The marker 128 is located within the second region 172 or below the longitudinal plane 168. It may be positioned on the lacquer frame 102. In this example, the first region 170 The first number marker 128 in the area is greater than the second number marker 128 in the second area 172. To increase the number of markers, more or fewer markers 12 are placed in each region 170 and 172. 8 is possible.

[0040] The Tracker 100 is compatible with various different surgical navigation systems and position tracking technologies. It can be made compatible. For example, the Tracker 100 can be made compatible with the camera unit or a separate This involves employing passive tracking markers that reflect infrared or infrared radiation emitted from a light source. This is possible. One embodiment of a navigation system is described herein, but the navigation The system may have any other suitable configuration for monitoring tracker 100. They may be of various types and configurations. For example, a navigation system may be a different type It can be equipped with an Ip camera and / or marker 28.

[0041] In some embodiments, the navigation system is radio frequency (RF) based. That's fine. For example, the Tracker 100 may be equipped with an RF emitter or transponder. These can be done, and they may be energized passively or actively. Alternatively, some implementations In terms of form, the navigation system may be electromagnetic (EM) based. For example. The navigation system is coupled to computing devices, controllers, etc. It can be equipped with an EM transceiver. Here, the tracker 100 is equipped with an EM component Trackers (for example, various types of magnetic trackers, electromagnetic trackers, inductive trackers, etc.) are available. It may be attached, and it may be either passively or actively energized.

[0042] As shown throughout the drawings, and especially with reference to Figure 7, marker 128 is hand Infrared radiation or red light that can be detected by surgical navigation systems It is an external emitter. The ambient lighting used by surgeons emits in the visible light spectrum, Infrared wavelengths are preferred, but infrared light wavelengths can be detected by surgical navigation systems. The wavelength of the effective marker 128 is such that its brightness is essentially independent of the brightness of the ambient light. Therefore, by marker 128 emitting infrared light, marker 128 moves at a lower brightness. Because this can be done, the current required to supply power to marker 128 is reduced. The current required to supply power to the marker may be 15mA or less.

[0043] Here, the infrared emitter is an infrared light-emitting diode (IR-LED), and it uses relatively low power. At a certain power level, it can emit infrared radiation and infrared light. One current is drawn through the internal electrical resistance of the IR-LED, and through the power supplied to at least one IR-LED. It can be limited by the electrical resistance of at least one resistor connected in series. At least one IR-LED's current is connected electrically in series with at least one IR-LED. It can be restricted by one or more consecutive resistors.

[0044] Tracker 100 is located within tracker frame 102, and is further described below. It is equipped with an air circuit. The electrical circuit includes an IR-LED (shown as marker 128) and a battery 18 2, and resistors (not shown). The electrical circuit powers each of the IR-LEDs from battery 182. Includes electrical wiring (not shown) to electrically connect each component. IR-LED, battery 182, The resistors are connected electrically in series. Therefore, the IR is determined by the electrical resistance of the resistors. -The LED current is limited. Because resistors have electrical resistance, the current of the IR-LED is approximately The current does not exceed 15mA. In one embodiment, the IR-LEDs are electrically connected in parallel to each other. Therefore, even if one of the IR-LEDs fails, the battery 182 and the remaining I The electrical connection with the R-LED is not interrupted. Each resistor is directly connected to the corresponding IR-LED. A series circuit is formed. Furthermore, each IR-LED has its own electrical resistance, resulting in This applies to the electrical resistance of a series circuit. According to Ohm's law, current is inversely proportional to resistance. Therefore, by adjusting the resistance of each resistor, the resistor and its corresponding IR -The current flowing through the LED can be adjusted. An exemplary circuit configuration is shown in this specification. This is incorporated into the book and can be found in U.S. Patent Application Publication No. 2019 / 0321108.

[0045] In one configuration, the Tracker 100 has four resistors, equal to the number of IR-LEDs. Alternatively, the Tracker 100 can be equipped with a different number of resistors. Each resistor is, It is placed between the battery 182 and its corresponding IR-LED. The resistor is a tracker frame. Located within Room 102, each resistor is electrically connected in series with its corresponding IR-LED. The resistor is electrically connected between the IR-LED and the positive terminal of battery 182. Alternatively, at least one resistor is connected to the corresponding IR-LED and the negative terminal of battery 182. They may be electrically connected between them. This embodiment includes fewer resistors. Therefore, the material cost is low. Alternatively, multiple resistors each supply electrical power to multiple IR-LEDs. They may be connected in series. For example, two resistors may each be electrically connected in series with the IR-LED. It may also be connected to it.

[0046] The electrical circuit is user-operable and configured to electrically switch on and off. It can further be equipped with a switch 186. Thus, the battery 182 and IR -By operating the switch 186 that opens and closes the electrical circuit connected to the LED, IR - The LEDs can be operated. Alternatively, the power supply to each IR-LED can be controlled individually. Multiple switches configured to control the operation may be provided. As a further alternative, a track The K100 may be equipped with at least one single-use switch. For single use, remove insulating material (e.g., paper, or Mylar or Kapton) This can be achieved by switch 186 including polymer strips, and switch 18 6 is configured to close the electrical circuit when the insulating material is removed. Alternatively, a single The switch used is an exposed contact that is shorted together when the Tracker 100 is assembled. It may be implemented as a ct.

[0047] The electrical circuit controls the radiation intensity of at least one IR-LED to 40 microwatts per minute. Radians (μW / sr), preferably 20 μW / sr, more preferably 10 μW / sr The circuit may be configured to limit the limit so as not to exceed it. The electrical circuit has at least one IR-LE The maximum or average radiation intensity of D is set to 0.1 μW / sr to 40 μW / sr, for example, 0 Limit the power consumption to 0.5 μW / sr to 20 μW / sr or 1 μW / sr to 10 μW / sr. It may be configured in such a way. As mentioned above, the electrical circuit may be a part of a plurality of IR-LEDs or It may be configured to limit the total radiant intensity to 40 μW / sr or less.

[0048] Battery 182 is implemented as a single button cell (also called a coin cell). However, the 182 battery can also contain multiple batteries. Button batteries are light Because of the battery size, the Tracker 100 is lightweight. The Battery 182 weighs less than 5 grams. It can have a mass of, for example, 3 grams. Battery 182 is a primary battery, not a rechargeable battery. It may be a battery, or a rechargeable secondary battery. Battery 182 The anode material can be a zinc or lithium-containing material. Battery 182 is , such as the commonly available round or cylindrical CR2032 or CR2025 battery. It may be alkaline or lithium type. Alternatively, battery 182 may be air zinc battery It can also be a battery. Battery 182 is 100 milliampere-hours (mAh) to 1000 It can have a capacity of mAh (for example, 200mAh to 400mAh).

[0049] In Figures 3, 5, and 6, battery 182 is shown by a dashed line, and battery 182 is It is located inside the tracker 100 122 to detect contaminants that may be generated during surgery (e.g., blood, The diagram shows that the battery 182 is designed to be protected from water and disinfectants. In various embodiments shown through the body, the battery 182 is transmitted by the user to the tracker 1 00 may be removable. Alternatively, battery 182 may be detachable by the user. It may be impossible to remove from the 100 (for example, if the 100 is a disposable item) (When configured as follows). The current of at least one of the multiple markers 128 is limited. Therefore, battery 182 may be sufficient as a power source, and an external power source may not be necessary. The Tracker 100 does not need to have a power cord for an external power source.

[0050] Battery 182 provides a DC voltage, for example, 3V. The operating voltage of each IR-LED. For example, the voltage is 1.5V. Therefore, in each resistor, 3V - 1.5V = 1. The 5V battery voltage drops. The electrical resistance of each resistor is 150Ω. Therefore, each The current flowing through the resistor and, consequently, each IR-LED, is 1.5V / 150Ω = 10mA. By adding a resistor, the electrical circuit ensures that the current of each IR-LED does not exceed 15mA. It is configured to limit the IR-LED's output. In this way, the electrical circuit also limits the IR-LED's output. Limit the radiant intensity of at least one of the devices so as not to exceed 40 μW / sr lumens.

[0051] The coin cell battery in the 182 series is lightweight, but also has a small capacity (e.g., 520mAh). The electrical circuit optionally allows you to set the current for each IR-LED to 15mA or 20mA. Because it is configured to limit the capacity so that it does not exceed the limit, the capacity of the coin cell battery is a common surgical navigation system. This is sufficient to safely operate the Tracker 100 during the procedure. For example, Using a 520mAh CR2032 battery, one IR-LED is powered by 1 When power is supplied with a current of 0mA, the Tracker 100 has a capacity of 520mAh / (4 × 10mA) = It can operate for a period of 5.5 hours. Tracker 100 is Tracker 100 It may be configured to accommodate an additional battery to extend the operating period. For example, the Tracker, equipped with two 520mAh batteries, can last for over 10 hours. It can operate in this way.

[0052] Since the current load is reduced, tracker 100 is configured for continuous operation of marker 128. The tracker 100 will operate at least two of the multiple markers 128 simultaneously. It may be configured as follows. Tracker 100 will operate all markers 128 simultaneously. It may be further configured. Alternatively, the tracker 100 may sequentially track multiple markers 128. It may be configured to operate.

[0053] Alternatively, the tracker 100 may be configured for semi-continuous or pulsed operation. Continuous operation allows adjustment of the brightness of marker 128 via a pulse width modulation (PWM) circuit or the like. The circuit may further include the duty cycle of the electrical signal supplied to marker 128. However, by changing it to be on for a larger proportion of time than when it is off, the brightness The coefficient of the This is possible. This type of semi-continuous operation reduces the power consumption of the Tracker 100.

[0054] In addition to the IR-LEDs mentioned above, the Tracker 100 also features an IR-LED, battery, and resistor. A circuit for a status indicator is electrically coupled to at least one of the resistors. It can be prepared for the following. In one implementation form, the status indicator is visible (that is, It can include an LED that emits non-infrared light, and the Tracker 100 is activated and functioning. The status indicator allows surgeons to easily confirm its presence. Even if configured to provide additional diagnostic information or operational information such as battery level to the surgeon Good. For example, when the battery voltage corresponds to the first level, the status indicator It may blink or flicker, and when the battery voltage corresponds to the second level, the stator The status indicator may be turned off. The status indicator may also have multiple LEs. D may be implemented with LEDs that can light up in multiple colors. In this case, the battery voltage level may correspond to the number of LEDs lit simultaneously. (Multicolor LED) When using D, the color may correspond to the battery voltage level.

[0055] As mentioned above, the marker 128 is placed in each of the radial portions 112, 114, and 116. By doing so, or by having a certain number of them located on one side of the longitudinal plane 168, the longitudinal It is positioned around the directional axis 108. These configurations enhance the visibility of the tracker 100. Therefore, a surgical navigation system that accurately determines the position and orientation of the surgical instrument 34 Enhance the capabilities of Tem. Furthermore, these configurations have multiple angles centered on the longitudinal axis 108. The marker 128 is positioned at a certain angle, and the marker 128 emits infrared radiation or infrared light along the longitudinal direction. It can be emitted radially at an angle of at least 260 degrees around the directional axis 108. This radial emission is shown in Figure 7, illustrating the exemplary emission from each of the multiple markers 128. The patterns are shown for tracker 100 and surgical instrument 34. Radiation shown here The emission of the shape is 360 degrees around the longitudinal axis 108. Here too, marker 128 It is an IR-LED and has a virtual total emission angle of 174 degrees, approximately 150 degrees. In other words, IR -Each LED is at an angle of 75 degrees from the normal 175 (see Figure 25) or the center line of the peak intensity. At this angle, it can emit at least 50% of its peak intensity radiation, and this angle is generally This is called a half-angle. The normal vector 175 of the IR-LED is approximately perpendicular to the mounting plane of the IR-LED, and - Defines the centerline of the intensity. Greater or smaller than 65 degrees or 85 degrees, for example. An IR LED with a half-angle value can be implemented in the alternative. Exemplary emission of 150 degrees. The IR LED configuration with an angle of 174° allows surgeons to use it as needed during the surgical procedure. Tracker 100 on the longitudinal axis 108, which may occur when manipulating surgical instrument 34 Through approximately 360-degree rotation, the radiation or light emitted from the IR-LED is used for navigation. It can be made visible in the system.

[0056] In some embodiments, the distance between at least two of the plurality of markers 128 is It may be smaller than 70 millimeters (mm). At least two of the multiple markers 128. The distance between the two points can be between 1mm and 70mm, for example, 3mm to 35mm, or 5mm to 30mm. It may be within that range. As explained below, even if marker 128 is placed on the common plane That's fine. Alternatively, marker 128 may be configured not to be placed in the common plane.

[0057] Referring to Figure 11, each electrical circuit includes an IR-LED (i.e., marker 128), The R-LED is attached to printed circuit board (PCB) 176, 178, 180 (for example, by soldering). The printed circuit board is mounted (by means of) and coupled to the tracker frame 102. Here, three PCBs 176, 178, and 180 are shown, and three markers 128 are on each PCB It is coupled to PCBs 176, 178, and 180. Each of PCBs 176, 178, and 180 is Here, it is shown as a battery 182 used to supply power to multiple markers 128. It is electrically connected to the voltage source. PCBs 176, 178, and 180 are substantially flat and planar in shape. It has components, and the marker 128 and other components (such as the resistor described herein) are attached. More specifically, each PCB176, 178, and 180 has its own marker 1 This defines planes 176A, 178A, and 180A that are approximately perpendicular to the direction in which 28 emits radiation. Two or more PCBs 176, 178, and 180 are arranged so that they are not parallel to each other. It is located at PCBs 176, 178, and 180. It may be connected to only one of the electrical circuits. Here, battery 182 is connected to the upper PC It is electrically coupled to B176. Each of the other PCBs, 178 and 180, is connected to all markers 1 To supply power to 28, it is electrically coupled to the upper PCB176 via wiring. Alternatively, all markers 128 may be bonded to a single flexible PCB, and this flexible PCB The CB has a single surface in which the PCB is oriented in at least three different directions due to its flexible portion. It is configured to allow this to happen.

[0058] As described below in relation to the fourth embodiment of tracker 100'' shown in Figure 22, Some embodiments may include a battery receptacle such as tray 183''. This battery receptacle holds battery 182 and connects battery 182 to IR-L Slidably engaged with tracker frame 102''' to be positioned in electrical communication with ED. It may be possible. In some configurations, the battery 182 and the battery tray 183 It is positioned to engage directly with the PCB in a low-profile configuration. Battery 182 is a button cell battery. When configured as a battery (for example, a CR2032 as mentioned above), the circular shape of the battery One of the surfaces contacts a conductive element of the PCB. The battery 182 is brought into contact with the PCB. By arranging them this way, the overall height of the PCB assembly can be minimized. As mentioned above, Reducing the height of the Tracker 100 is advantageous because it reduces the angle of the line of sight (188) during use. ru.

[0059] When marker 128 is configured as an infrared emitter or IR-LED, it Since they are coupled to their respective non-parallel PCBs 176, 178, and 180, each marker 128 is It emits radiation perpendicular to the planes 176A, 178A, and 180A in which it is positioned. Therefore, Marker 128 is at least equivalent to the existence of non-parallel planes 176A, 178A, and 180A. It collectively emits radiation in the direction of the number. Here again, refer to Figure 7 which shows three different directions. ru.

[0060] To utilize the radial emission characteristics brought about by the configuration of marker 128, surgical The navigation system determines which marker 128 is in a specific position on the tracker frame 102. It may be possible to decide whether to respond. As mentioned above, multiple markers 128 are less They are arranged to form two arrays, and each array has at least three markers 128 It has such that a portion of each array is coupled to the offset body 110. More specifically, as shown in Figure 11 The tracker 100 shown consists of three arrays 162, 16 coupled to the tracker frame 102. 4, 166 are provided. The first array 162 is coupled to the offset body 110, as shown in Figure 11. It faces upwards. The second array 164 is connected to both the mounting body 104 and the offset body 110. They are joined together and face the lower left of Figure 11. The third array 166 also has mounting body 104 and offset body Both 110 are coupled and face the lower right of Figure 11. However, the arrangement of other arrays is considered. It is possible.

[0061] At least two arrays 162, 164, 166 are coupled to the offset body 110. In addition to parts of each of the above, parts of at least two arrays 162, 164, and 166 are , positioned proximal to the mounting body 104, and a small At the very least, parts of the two arrays 162, 164, and 166 have just one marker 128 Includes. As mentioned above, a portion of the offset body 110 protrudes proximally from the mounting body 104. And terminates at the proximal end 152. The proximal end 152 of this offset body 110 and similarly the trough The buck frame 102 is positioned proximal to the proximal end 36 of the surgical instrument 34. Figure 7 shows the most As clearly shown, the first array 162, the second array 164, and the third array 166 Three markers 128, one from each side, near the proximal end 152 of the offset body 110. The surgical instrument 34 is positioned on the tracker frame 102 at a location proximal to the proximal end 36.

[0062] The camera uses two lasers to focus the infrared light emitted by multiple IR-LEDs. Includes lenses. Lenses let in more light compared to non-focusing apertures like slit apertures. This allows light to enter the camera. Therefore, the camera operates on a limited current. It can detect low-brightness light sources such as IR-LEDs.

[0063] The camera further includes two 2D image sensors 66. The 2D image sensors 66 are stereoscopic It can sense angles (i.e., 2D angles). On the other hand, conventional 1D sensor arrays, Typically, this requires synchronization with the detected light source, enabling tracking of a single light source per scan. It is possible that the 2D image sensor 66 can detect all IR-LEDs at once. Therefore, the Tracker 100 can do at least two, especially all of the multiple IR-LEDs. They can be configured to operate simultaneously. Such simultaneous operation involves the camera and the Tracker 100. It does not require synchronization with the camera. Therefore, the Tracker 100 does not require communication with the camera. Because it does not require an interface (e.g., a wireless transceiver), the Tracker 100 The weight becomes even lighter. Another advantage of the Tracker 100, which does not include a transceiver, is that it transmits To protect the signal from unwanted interference with external systems, and to prevent unwanted signal interference in the received signal. This includes preventing interference, reducing costs, and lowering complexity.

[0064] The surgical navigation system consists of two 2D image sensors, which are part of a stereo camera. Such a stereo camera can capture three-dimensional image data. This is possible. Therefore, known spatial relationships between IR-LEDs are not necessary. A stereo camera can be used when attaching a single IR-LED to a patient. Since it is installed manually, the spatial relationship between the IR-LEDs is unknown. However, The REO camera can capture 3D image data, so it uses IR-LEDs to capture stereo images. It can be tracked by Mera.

[0065] In one configuration, the identification of each of the arrays 162, 164, and 166 is up to each marker 128. By determining the distance and triangulating the position from the aforementioned camera, surgical navigation is performed. This is done by a combination system. Each array 162, 164, and 166 is configured in multiple dimensions (e.g., 2 Independent tracking in D or 3D involves multiple marks on arrays 162, 164, and 166. This is achieved by constructing with K128. As shown throughout the drawing, a total of 9 In the case of one marker 128, each array 162, 164, 166 is determined by three markers 128. It is defined as follows. In order to accurately distinguish each array 162, 164, and 166, marker 128 The specific arrangement can vary among arrays 162, 164, and 166, respectively. The first array 162 has three vertices, each with a common reference point for each of the markers 128. A first region 162A (Figure 6), which is a rectangular region, can be defined. Similarly, the second Array 164 can define a second region 164A (Figure 8), and a third array 16 6 can define a third region 166A (Figure 5), a second region 164A and a third region Both regions 166A have vertices at the common reference point of each of the respective markers 128. Based on a rectangular region. Here, the first region 162A is larger than the second region 164A. Often, the second region 164A may be larger than the third region 166A.

[0066] Another example, particularly tracker 100 shown in Figures 22-26 (which will be explained in more detail below) In ( ), the second region 164A''' and the third region 166A''' may be equal. Here, the second array 164''' and the third array 166''' are respectively The array may be composed of markers 128'''' at the same position. Second array 16 4'' and the third array 166'' are dimensionally in opposing or mirrored configurations. They may be identical (or substantially identical). This provides a good appearance and reduces manufacturing costs. It can be reduced.

[0067] Next, referring to Figures 12 to 16, the tracker frame 102' is the cam lock retaining mechanism 1 Another implementation of Tracker 100', including 36', is shown. Tracker 100' is multi In this respect, it may be similar to the one mentioned above, and the same numbers (and prime symbol (')) have a similar structure Disclosures corresponding to the constituent elements and common to the corresponding constituent elements have been omitted for brevity. It can be considered as such and should not be interpreted as being limited. Tracker frame 102' The corresponding component inserts the surgical instrument 34 into the instrument engagement opening 106' in the manner described above. It can be removed from the device engagement opening 106' in an appropriate manner. Please understand that this may be modified. Furthermore, the mounting body 104', for example, the aforementioned mounting body 10 This is described in the context of a retaining mechanism 132' that can be integrated with or coupled to 4, but this disclosure More generally, applicable to Tracker 100' and / or Tracker Frame 102'. Please understand that this could be a form of Noh theater.

[0068] Figures 12 to 16 show the mounting body 104' and the offset body 11 supported by the mounting body 104'. A tracker 100' is shown, comprising a tracker frame 102' having 0'. Similarly, the mounting body 104' is slidably engaged with the surgical instrument 34 at its proximal end 36. The configured instrument engagement opening 106' is defined. The distal end 38 of the surgical instrument 34 is instrument engagement It is inserted proximal to the opening 106' and connected to the proximal end 36 of the surgical instrument 34, and is connected to the instrument. Until the collar, which has a diameter larger than the fitting opening 106', comes into contact with the mounting body 104', It slides in the lateral direction. The collar defines a complementary recess within the housing 46 of the surgical instrument 34. Furthermore, this recess engages with the mounting projection 148' adjacent to the device engagement opening 106'. This is configured. Here, the retaining mechanism 132' is an inclined cam surface that engages with the collar of the surgical instrument 34. It has a release knob which engages the surgical instrument 34 with the instrument engagement opening 106'. Bias it so that. When you move the knob to the release position, the collar comes off and the surgical instrument 34 It can be removed from the Tracker 100'.

[0069] Figure 16 shows radial portions 112', 114', and 116' arranged around the longitudinal axis 108'. This shows how it is placed. The asymmetrical arrangement of marker 128' on tracker frame 102' is It emits infrared radiation or infrared light at a range of at least 260 degrees around the longitudinal axis 108'. This improves the visibility of the Tracker 100' using the surgical navigation system. To make it easier, some placements of marker 128' are 360 ​​degrees around the longitudinal axis 108'. It can emit light.

[0070] Next, referring to Figures 17 to 21, the tracker frame 102" is a space frame structure. Another implementation of the Tracker 100" is shown. Here too, the Tracker 100" It features a cam lock retaining mechanism 136”. The Tracker 100” is similar in many ways to the aforementioned... They can be similar, and similar numbers (and double prime symbols (")) correspond to similar components, and opposite Disclosures common to the corresponding components can be considered omitted for the sake of brevity. It should not be interpreted as being limited. The corresponding component on tracker frame 102” The surgical instrument 34 can be inserted into the instrument engagement opening 106" in the manner described above, and the instrument It may be modified in an appropriate manner so that it can be removed from the engagement opening 106” Please understand. Furthermore, as explained in the context of Tracker Frame 102, this disclosure is more Generally applicable to Tracker 100" and / or Tracker Frame 102" Please understand that this is possible.

[0071] Figures 17 to 21 show the mounting body 104" and the offset body 11 supported by the mounting body 104". A tracker 100" is shown, comprising a tracker frame 102" having 0". Similarly, the mounting body 104" is slidably engaged with the surgical instrument 34 at its proximal end 36. The configured instrument engagement opening 106" is defined. The distal end 38 of the surgical instrument 34 is instrument engagement It is inserted proximal to the opening 106" and connected to the proximal end 36 of the surgical instrument 34, and the instrument is connected Until the collar, which has a diameter larger than the fitting opening 106”, contacts the mounting body 104”, It slides in the direction of the position.

[0072] In this implementation, the tracker frame 102" is formed from a curved plate, thereby creating three Each of the sides forms the tracker frame 102" with three sides as shown in Figure 21. It is bent to align with the projectile sections 112”, 114”, and 116”. Tracker The 102" frame is formed from lightweight and durable metal materials such as titanium. Since the "K100" is intended to be reusable, the structure consists of several components. Allows for inspection or replacement. For example, at least two arrays 162”, 16 The 4" and 166" are joined to the tracker frame 102" by screw parts. Therefore, at least two arrays 162”, 164”, and 166”, were removed for cleaning. It is possible.

[0073] As mentioned above, multiple markers 128'' are such that at least one marker 128'' is Tracker frames are positioned to be located in the radial sections 112”, 114”, and 116”. It is positioned on the 102" axis. In addition, Figure 21 is parallel to the longitudinal axis 108", and The device engagement opening 106" is divided into two equal parts to define a first region 170" and a second region 172". The sides of the defined longitudinal plane 168" are shown. The placement of the marker 128" is in the first region 170" and further specified with respect to the second region 172"; multiple markers of the first number 128" The first region 170" is positioned, and the second number of multiple markers 128" are positioned in the second region 1 It is positioned at 72", and the first number is greater than the second number.

[0074] Figure 18 defines a relief region 160” that provides a gap for the flexible supply cable 48. To determine this, the proximal end 15 of the offset body 110" is spaced apart around the longitudinal axis 108" It shows 2". Here too, at least two arrays 162”, 164”, and 166”, 、positioned proximal to the attachment body 104”, and this portion includes exactly one marker 128 .

[0075] Some embodiments of the tracker 100 may be composed of a PCB as an outer surface facing outward, exposed, and likely to come into contact with debris or fluid. Short circuits may damage components coupled to the PCB, such as the marker 128 or resistors, which may cause undesirable operation of the tracker 100. Each PCB and component forming the tracker array may be protected by applying a conformal coating that creates a barrier on the PCB to prevent the intrusion of debris and fluid. An exemplary conformal coating may include a parylene film applied to the assembled PCB.

[0076] Next, referring to FIGS. 22 - 26, another alternative implementation of the optical tracker 100''' is shown without the handheld surgical instrument 34. In this implementation of the tracker 100''', the holding mechanism 132 takes the form of a lever clamp 192'''. As described above, the tracker 100''' may be similar in many respects to those described above, and like numbers (and triple prime symbols (''')) correspond to similar components, and the disclosures common to the corresponding components may be considered to be omitted for brevity and should not be construed as limiting. Here, the lever clamp 192''' is coupled to the tracker frame 102''' at a first end, and includes two elastic arms 194''' spaced apart from each other at a second end, and a lever 196''' pivotally coupled to the second end of the elastic arms 194'''. The elastic arms 194''' cooperate to be along the longitudinal axis 108''' within the attachment body 104''' and at the second end, a lever 196''' pivotally coupled to the second ends of the elastic arms 194'''. The elastic arms 194''' cooperate to be along the longitudinal axis 108''' within the attachment body 104''' The elastic arms 194''' cooperate to be along the longitudinal axis 108''' within the attachment body 104'''​​​​​ This defines the extending device engagement opening 106''''.

[0077] The offset body 110''' is supported by the mounting body 104' and extends in the proximal direction. The body 110''' is spaced apart from the longitudinal axis 108''' and is adjacent to the longitudinal axis 108'''. A notch 118''' is defined that penetrates the offset body 110' in a nearly vertical direction. The tracker frame 102'' has a triangular shape corresponding to one face of the roughly tetrahedron-like shape. Within the offset body 110''', which indicates that, is the lever 196'''. Lever 19 6'' is a clamp used to secure the tracker frame 102'' to the surgical instrument 34. It is rotatable between a fixed position and an unclamped position (not shown).

[0078] Each elastic arm 194''' has an ear portion 198''' at one end. Lever 196''' It engages with each ear portion 198''' and the longitudinal axis 108' of the tracker frame 102''' It is rotatable around a lever axis that is approximately perpendicular to ''. In one example, each ear portion 198'' is A lever support hole can be defined that penetrates the lug portion 198'' along the lever axis. Lever 196''' has two pins positioned on the lever shaft and capable of engaging with the lever support holes. It can include a pin. The engagement of the pin with the lever support hole allows for clamping and non-clamping positions. The rotational movement of lever 196''' between positions is facilitated. In another example, lever 19 6'' and ear portion 198'''' have a pin and lever 1 protruding from ear portion 198''''. It may be configured with lever support holes as specified in 96''.

[0079] As mentioned above, the tracker frame 102'' is made of plastic or polymer material. This may include the tracker frame 102''', which can be injection molded or laminated. It can be formed using a molding process, and the tracker frame 102'''' can be a single unit. Formed by forming the tracker frame 102''' as a single unit, This eliminates steps such as assembling the 192''' into the tracker frame 102'''. This can be achieved. Furthermore, by reducing the accumulation of tolerances, the tracker frame 102'' This can improve the dimensional accuracy. In addition, by eliminating joints between parts, traction can be reduced. The rigidity of the 102''' frame can be increased. By joining multiple parts together The geometric shape formed for this purpose further reduces the weight of the Tracker Frame 102''. This can be eliminated by reducing the need to control the precision of the mating surface. Elastic arm 19 4'' is slightly flexible when formed from plastic or polymer material. Because this is possible, the ear portions 198'' can be displaced relative to each other, and thereby, the ear The distance defined between section 198''' can be reduced. When 6''' is rotated from the non-clamped position to the clamped position, the ear portions 198''' move closer together. Therefore, the diameter of the instrument engagement opening 106' becomes smaller. The surgical instrument 34 is the instrument engagement opening Inserted into 106'', when lever 196''' is swung to the clamp position, the elastic arm The 194''' is tightened against the outer surface of the surgical instrument 32, preventing relative movement between them. ingredient.

[0080] The structures of Tracker 100, 100', 100'', and 100''' described herein are low-cost. In promoting the creation of disposable trackers for strikes, reduce both mass and size. is optimized. In some embodiments, the mass of the tracker including the battery is 40 g and may be so. Some embodiments of the tracker including the power supply can have a mass of less than 50 g, 40 g, or less than 35 g respectively.

[0081] Also, a method for calibrating and aligning the tracker 100 and the tracking array for a surgery using a localizer is disclosed. Referring to FIGS. 24-26, steps for calibrating and aligning a tracking array in which a first tracking surface TF1 and a second tracking surface TF2 are coupled to each other are shown. The tracking array can further include a third tracking surface TF3 coupled to both the first tracking surface TF1 and the second tracking surface TF2. The method steps are shown in the context of the fourth implementation form of the tracker 100''' described above, but the steps are applicable to each of the trackers 100, 100', 100'', 100''' described herein. Therefore, any of the trackers 100, 100', 100'', 100''' can be calibrated according to the method described below. Elements described in relation to this method are substantially similar among each of the four implementation forms, and similar numbers correspond to similar components, and prime symbols are omitted for clarity. Calibrate the tracker in the operating room to achieve high tracking accuracy. High tracking accuracy can correspond to accurate and precise measurement of the relative positions of each of the optical tracking elements. By calibrating the tracker on-site, the navigation system can accurately measure the position of each of the optical tracking elements and compensate for high manufacturing tolerances. The high accuracy achievable by the calibration procedure allows for low-cost

[0082] ​​​​​​​​​​​​​The tracker can be manufactured in a way that can make it lightweight. Exemplary implementation of the tracker In terms of form, the tracker frame is formed using a stereolithography process and epoxy resin. It is possible.

[0083] Calibration and alignment of the tracking array should be performed by the user, such as a surgeon, before or at the start of surgery. Next, connect the tracker 100 to the medical device 34 or the patient, and activate the tracker 100. It can be started by (for example, by activating a single-use switch) Yes, it is possible. Alternatively, the calibration and alignment procedure may be performed when the tracker is identified, or when the user enters The procedure may be automatically initiated by the surgical navigation system 12 via force 16. When correction and alignment are initiated, the navigation processor 18 will send a message to the display unit 14. A first set of instructions can be provided to the user. These instructions are static steps Even in the case of a strike, it may be dynamically updated as described later.

[0084] Some embodiments of the surgical navigation system 12 include a memory device (not shown). This can store the manufacturing dimensions of the tracking array. The manufacturing dimensions are stored in the first tracking plane TF. Geometric data of plane 1, geometric data of the second tracking plane TF2, and the third tracking plane TF3 It may include a first set of geometric data, which includes the geometric data of the first tracking surface. The scientific data includes the predicted relative positions of multiple optical tracking elements 128 on the first tracking surface TF1, and multiple The relative positions of the optical tracking elements 128, and the multiple optical tracking elements 12 on the first tracking surface. It may include data indicating the predicted opposing direction of 8. The geometric data of the second tracking surface is the second tracking Predicted relative positions of multiple optical tracking elements 128 on the trace surface TF2, and the relative positions of multiple optical tracking elements 128. The position relative to the second tracking surface 128, and the expected opposing direction of the multiple optical tracking elements 128. This may include data showing the geometric data of the third tracking surface, multiple of the third tracking surface TF3. The expected relative position of the optical tracking element 128, the relative positions of the multiple optical tracking elements 128, This may include data indicating the expected opposing directions of multiple optical tracking elements on the third tracking surface TF3. These data are the distance between individual optical tracking elements 128, the angle of the normal 175, and the expected This may further include manufacturing position tolerances and other data that can characterize the tracking array.

[0085] The first tracking surface TF1, the second tracking surface TF2, and the third tracking surface TF3 are each navigating The system may include multiple optical tracking elements 128 detectable by the tracking system 12. The calibration of the tracker 100 is performed on the first tracking surface TF1, the second tracking surface TF2, and / or At least two of the optical tracking elements 128 of the third tracking surface TF3 are at least part By positioning the tracking array so that it is partially visible to the localizer 22, It can be started. In the next step, multiple optical tracking elements 128 are visible to the localizer 22. During a certain period, the relative positions of multiple optical tracking elements 128 are measured.

[0086] As mentioned above, the optical tracking element 128 (or marker) is an infrared light-emitting diode (IR- This may be an LED, which is a roughly conical beam along the normal 175 and emits an infrared spectrum. It emits light. However, the optical tracking element 128 emits infrared light near the localizer 22. A reflection tracking element that reflects light from a radiation source in a direction closely aligned with an infrared source or It may be implemented as a retroreflector.

[0087] As mentioned above, each of the tracking elements 128 is approximately perpendicular to its respective tracking plane and has a peak. It has a normal vector 175 that defines the center line of intensity. In other words, the direction of the normal vector 175 is optical. Represents the opposing direction of the tracking element 128. Measures the relative position of multiple optical tracking elements 128. In addition, the navigation system 12 has multiple optical tracking elements 128 that track each tracking surface. - While visible to the colorizer 22, the normals 175 of multiple optical tracking elements 128 are detected. This is possible. For example, when the tracker includes an array that defines three distinct regions, how many In that tracker configuration, the detection step may be omitted.

[0088] In some implementations of the Tracker 100, the tracking array has the same geometry as the optical tracking element 128. It may be configured to have two tracking surfaces arranged in a specific configuration. In other words, optical tracking The tracking element 128 is positioned on one tracking surface at the same relative position as the optical tracking element 128 on the other tracking surface. They are arranged. In the exemplary example shown in Figure 24, the second tracking surface TF2 is one of the tracking surfaces. The third tracking surface TF3 is the other tracking surface. The second tracking surface TF2 and the third tracking surface The distance between each of the optical tracking elements 128 in TF3, or their relative positions, is the same. Furthermore, the optical tracking element 128 on each of those tracking surfaces is located in the same triangular area. It is defined. However, as can be seen in Figure 24, the second tracking surface TF2 and the third tracking surface TF3 is a specular arrangement, where the normal vectors 175 of each optical tracking element 128 are separated from each other. The navigation processor faces the direction. For each of the visible optical tracking elements 128, Alternatively, the normal 175 / opposing direction is determined for at least one optical tracking element 128 on each surface. This allows us to distinguish between two or more tracking surfaces.

[0089] When the normal 175 of the visible optical tracking element 128 is detected, the optical tracking element 128 is measured Based on their relative positions and opposing directions, they are grouped into a first rigid body and a second rigid body. The first rigid body and the second rigid body each include at least one tracking element 128. The measured relative position and opposing direction of the multiple optical tracking elements 128 of the third tracking surface TF3. Based on this, the multiple visible optical tracking elements 128 are further grouped into a third rigid body. good.

[0090] The method involves at least one of the optical tracking elements 128 of the first tracking surface TF1, and the second tracking... At least one of the optical tracking elements 128 of the tracking surface TF2, or the third tracking surface TF3 At least one of the optical tracking elements 128 is visible to the localizer 22 at the same time. The process further includes the step of positioning the tracking array. Each first tracking surface TF1, At least one optical tracking element belonging to the second tracking surface TF2 or the third tracking surface TF3 While 128 is visible simultaneously, the relative position is measured by the localizer 22. In that configuration, the positioning step is performed on the second tracking surface TF2 or the third tracking surface TF3 At least one optical tracking element 128 is visible, and at the same time, the first tracking surface TF1 It may be necessary that at least three optical tracking elements 128 be visible. Similarly, In order to establish the correspondence between the second tracking surface TF2 and the third tracking surface TF3, the second tracking surface T At least three optical tracking elements 128 of F2 are at least one of the third tracking surface TF3 It may need to be visible at the same time as the optical tracking element 128. Not limited to three tracking surfaces, The mounting configuration is useful for trackers with only two sides or four or more sides. I want to be treated that way.

[0091] Using the navigation processor 18, the first rigid body, the second rigid body, and the third rigid body The body, at least one optical tracking element 128 of the first tracking surface TF1, and the second tracking surface TF2 at least one optical tracking element 128 and at least one third tracking surface TF3 Based on the measured relative position of the optical tracking element 128, a composite rigid body can be created. Alternatively, at least one optical tracking element 128 of the first tracking surface TF1, the second tracking At least one optical tracking element 128 of surface TF2, and at least one of the third tracking surfaces TF3 Furthermore, a composite rigid body is created based solely on the measured relative position of another optical tracking element 128. That's good too.

[0092] Multiple optical tracking elements 128 of at least three optical tracking elements on a single tracking surface are measured. The tracker can be identified using its relative position. In some implementations, Another step can be based on the detected opposing direction data of multiple optical tracking elements. Cut.

[0093] The navigation processor determines the position of at least three optical tracking elements on the tracking surface and / Alternatively, the detected opposing direction is compared with a first set of geometric data to track the array. It is possible to identify the following. Identification is performed by predicting the multiple optical tracking elements 128 of the first tracking surface TF1. The expected opposing direction, the expected opposing direction of the multiple optical tracking elements 128 of the second tracking surface TF2, and / Alternatively, it can be based on the expected opposing directions of multiple optical tracking elements 128 on the third tracking surface TF3. By utilizing the opposing direction, the localizer 22 can control the visibility of the optical tracking element. Despite the fact that it may be limited, it is possible to identify the tracker and measure accuracy at a wide angle. This helps avoid a decrease in accuracy. This identification step triggers the calibration workflow. It is possible.

[0094] As mentioned above and shown in Figure 26, the navigation system is designed to facilitate accurate calibration. The unit 12 can display calibration commands to the user via the display unit 14. These commands are for the calibration that the user is currently executing or has just completed. It can be updated according to the step. The instruction is at least one of the first tracking surfaces TF1 The optical tracking element 128 and at least one optical tracking element 128 of the second tracking surface TF2 At the same time, the tracking array is routed to the localizer 22 so that it is visible to the localizer 22. The instructions may include graphics to show the user that it is rotating. At least one optical tracking element 128 and at least one optical third tracking surface TF3 To ensure that the tracking element 128 is visible to the localizer 22 at the same time, It may further include graphics that show the user the tracking array rotating. The instruction then specifies that at least one optical tracking element 128 and the third tracking element of the second tracking surface TF2 should be connected. At least one optical tracking element 128 of the tracking surface TF3 is visible to the localizer 22 at the same time. The user is shown the possibility of rotating the tracking array relative to the localizer 22. It may include graphics. The third tracking surface TF3 and the first tracking surface TF1 mentioned above. However, the same steps can be encouraged.

[0095] The calibration and alignment method identifies the medical device 34 to which the tracker 100 is coupled. It may further include a top. Identification of medical device 34 is performed by the navigation processor. The composite rigid body of the tracker array created is related to a medical instrument 34 that may be used in surgical procedures. It is based on linking. In the same way, by associating the composite rigid body with the medical device 34, The trace array may be further assigned to a specific medical device 34. This method applies to medical device 3 By positioning a portion of 4 at a known reference position, a portion of the medical device 34 and the composite rigid body This can further include determining the positional relationship with [the object]. Tracker 100 is local Various techniques, such as touching off at a reference point being tracked by The 22. The procedure can be used to calibrate the medical device. In one example, the reference position is traceable. It is a known position on the calibration device.

[0096] Clause I. A method for operating a tracker, wherein the tracker includes a tracker frame 102 and The electrical circuit is supported by a lacquer frame 102, and the electrical circuit comprises at least one The electrical circuit includes an infrared light-emitting diode (IR-LED) and is battery-powered or powerless. The method further includes a wireless power receiving device configured to receive power via a wire, and the method is battery or wireless The power receiving device supplies power to operate at least one IR-LED. The step and the electrical circuit, at least one of at least one IR-LED A method comprising the step of limiting the current so as not to exceed 15 milliamperes (mA).

[0097] II. Position and orientation of trackers attached to surgical instruments within the surgical navigation system A method for tracking a vehicle, wherein the tracker defines a longitudinal axis and uses at least three infrared sensors It comprises at least three arrays, each having an emitter, and the at least three arrays are The method involves arranging radially around the longitudinal axis, and comprising at least three infrared emitters. The steps include measuring the position of each array to determine the position and orientation of each array, and the small size of each array. At the very least, calculate the correction coefficient corresponding to the position of one marker relative to each of the other arrays. The top and at least one marker in each array that is visible to the surgical navigation system The steps include determining the relative position and orientation, and using a correction coefficient, the less By correlating the relative position and orientation of one marker with the absolute position of the tracker, A method comprising the steps of determining the position and orientation of a tracker.

[0098] III. A method for calibrating a surgical tracking array using a localizer. The tracking array has a first tracking surface and a second tracking surface that are coupled to each other, and the first tracking The first tracking surface and the second tracking surface collectively include a plurality of optical tracking elements, and the method is to use the first tracking surface And the tracking array such that multiple optical tracking elements on the second tracking surface are visible to the localizer. The steps include positioning I and, while multiple optical tracking elements are visible to the localizer, The steps involve measuring the relative positions of several optical tracking elements, and the localization of multiple optical tracking elements. The steps include detecting the opposing directions of multiple optical tracking elements while they are visible, and detecting the opposing directions of multiple optical tracking elements. Based on the measured relative position and opposing direction of the trace elements, multiple optical trace elements are assigned to the first rigid A step of grouping the first rigid body and the second rigid body A grouping step where each of the groups includes at least one tracking element, and a first tracking surface At least one optical tracking element and at least one optical tracking element of the second tracking surface The steps include simultaneously positioning the tracking array so that it is visible to the localizer, and simultaneously While visible to the localizer, at least one optical tracking element of the first tracking surface and the A step of measuring the relative position of at least one optical tracking element on two tracking surfaces, and simultaneously While being a sight, the first rigid body, the second rigid body, and at least one optical plane of the first tracking surface Based on the measured relative position of the tracking element and at least one optical tracking element on the second tracking surface A method comprising the step of creating a composite rigid body.

[0099] IV. A method for calibrating a surgical tracking array using a localizer. The tracking array has a first tracking surface and a second tracking surface that are coupled to each other, and the first tracking The first and second tracking surfaces collectively include a plurality of optical tracking elements, and the method is performed on the first tracking surface The tracking array such that multiple optical tracking elements of the second tracking surface are visible to the localizer. The steps of positioning and multiple optical tracking elements while they are visible to the localizer A step of measuring the relative position of the optical tracking element and at least one optical of the first tracking surface At least one optical tracking element of the tracking element and the second tracking surface can be used simultaneously with the localizer. The steps involve positioning the tracking array so that it is visible to the localizer at the same time. During this time, at least one optical tracking element of the first tracking surface and at least of the second tracking surface A step of measuring the relative position of one optical tracking element, and simultaneously, while visible, the first tracking At least one optical tracking element on the trace surface and at least one optical tracking element on the second trace surface A method comprising the step of creating a composite rigid body based on the measured relative positions of the elements.

[0100] V. A disposable optical tracker for tracking surgical instruments, having a planar circuit A substrate and at least three IR- An arrangement of LEDs in which the distance between any two IR-LEDs is unique, and a small number of The current of at least three IR-LEDs is limited to no more than 15mA. It features an air circuit and a battery electrically connected to at least three IR-LEDs, and is disposable. The optical tracker does not include a communication interface or power cord; it is a disposable optical tracker. Student Tracker.

[0101] VI. The arrangement of at least three IR-LEDs is configured for continuous or semi-continuous operation. A disposable optical tracker as described in item V.

[0102] VII. The electrical circuit must have current flowing through at least one of the three IR-LEDs. The disposable optical as described in Section V, including at least one resistor configured to limit Tracker.

[0103] VIII. The current of at least one of the three IR-LEDs is at least Also, the internal electrical resistance of at least one of the three IR-LEDs, and at least three At least one resistor electrically connected in series to at least one of the IR-LEDs A disposable optical tracker as described in Section VII, limited by the electrical resistance of the instrument.

[0104] IX. The electrical circuit must have at least one irradiance of at least three IR-LEDs The system is designed to limit the output to no more than 40 microwatts per steradian (μW / sr). A disposable optical tracker as described in Section VII.

[0105] X. The distance between at least two of the three IR-LEDs is less than 70mm. Disposable optical trackers as described in Section VII.

[0106] XI. The electrical circuit is configured to operate at least three IR-LEDs simultaneously. The disposable optical tracker described in item VII.

[0107] XII. Disposable optical trackers whose mass does not exceed 40g, as described in Section VII. Optical tracker.

[0108] XIII. Further comprising a battery receptacle configured to engage with the battery. The aforementioned battery is further defined as a coin cell battery, as described in Section V, a disposable battery. Optical tracker.

[0109] XIV. A single-use switch electrically connected to at least three IR-LEDs. A disposable optical tracker as described in Section V, to be prepared for this purpose.

[0110] XV. Detect the light from the tracker described in Section V and at least one IR-LED. A surgical navigation system equipped with a camera capable of generating a camera signal indicating the light it has been illuminated. System.

[0111] Several examples are described in the above explanation. However, the following are not described in this specification. The examples given are not intended to be exhaustive, nor are they intended to limit this disclosure to any particular form. The terminology used is intended to be descriptive rather than restrictive. Many modifications and variations are possible in light of the above teachings, and the present invention is specifically described below. It can be implemented by methods other than those mentioned above.

Claims

1. Optical trace for handheld surgical instruments having a proximal end spaced apart from the distal end along the instrument axis. It is a kka, A tracker frame including a mounting body that defines an appliance engagement opening, wherein the appliance engagement opening The part defines the longitudinal axis, and the tracker frame is in the longitudinal direction of the device engagement opening. The axis is positioned to align with the instrument axis, and the proximal region of the surgical instrument is to be received. It is composed of three radial portions of equal proportions defined around the longitudinal axis, and the length The tracker frame collectively surrounds the hand-direction axis, and protrudes proximally from the mounting body. The set further includes a tracker frame, At least six optical markers coupled to the tracker frame, the least Each of the six optical markers is positioned so that at least one of them is located within each radial portion. At least six optical markers are positioned, Equipped with, At least two of the six optical markers are located near the mounting body. An optical tracker that determines the outcome.

2. Claim 1, the offset body extends from the distal end connected to the mounting body to the proximal end. Optical tracker as described.

3. The proximal end of the offset body is spaced apart from the longitudinal axis of the offset body. The optical tracker according to claim 2, which is spaced at a distance greater than the distance from the distal end. 。

4. The offset body is tapered from the distal end to the proximal end, claim 2 or Optical tracker as described in 3.

5. The proximal end of the offset body is positioned at only one of the radial portions. The optical tracker according to any one of claims 2 to 4.

6. The at least six optical markers are infrared LEDs, any one of claims 1 to 5. Optical tracker as described.

7. The at least six infrared LEDs emit light in succession and simultaneously, as described in claim 6. Optical tracker.

8. The at least six optical markers are arranged to form at least two arrays. Each array includes at least three of the six optical markers, and the minimum Claims 1 to 7 wherein at least a portion of each of the two arrays is positioned proximal to the mounting body. The optical tracker listed in any one of the following.

9. Each of the at least two arrays is coupled to the at least three optical markers The optical transistor according to claim 8, comprising circuit boards, wherein the circuit boards are non-parallel to one another. Okay.

10. The aforementioned at least six optical markers are further defined as at least nine optical markers. The optical tracker according to claim 8 or 9.

11. The aforementioned at least two arrays are further defined as at least three arrays, and At least three arrays are arranged radially around the longitudinal axis, and at The nine optical markers emit infrared light radially in a 360-degree arc around the longitudinal axis. The optical tracker according to claim 10.

12. The portion of each of the at least two arrays positioned proximal to the mounting body is , an optical track according to any one of claims 1 to 11, including exactly one optical marker mosquito.

13. The optical system according to any one of claims 1 to 12, wherein the tracker frame comprises a polymer. Tracker.

14. The coupling opening is defined in the mounting body, and the mounting body has two that are positioned in the coupling opening The present invention further includes an elastic arm, each elastic arm having a reference end and a movable end, and the elastic arm is The optical device according to any one of claims 1 to 13, which cooperates to define the engagement opening of the device. Rakka.

15. A single-use switch coupled to the tracker frame and electrically communicating with the optical marker Claim 1 further comprises a switch, wherein the single-use switch includes a removable insulating material. An optical tracker as described in any one of the following 14 items.

16. The line of sight defined between the tracker frame and the surgical instrument is less than 30 degrees. An optical tracker as described in any one of the requirements 1 to 15.

17. It is coupled to the tracker frame and is capable of pivoting about an axis parallel to the longitudinal axis. An optical tracker according to any one of claims 1 to 16, further comprising a latch.

18. The tracker frame comprises a pair of spaced-apart arms that cooperate to define the device engagement opening. The arm further includes a swivelly coupled to each of the spaced arms, and the spaced arms Claims 1 to 17 further include levers that are movable to bias the frames toward each other. An optical tracker as described in one of the following.

19. The tracker frame is connected to the mounting body and radiates outwards from the longitudinal axis. The mounting projection is further positioned at a single location along the axis of the device. The surgical instrument is configured to index and engage with the surgical instrument, as described in any one of claims 1 to 18. Optical tracker.

20. Having an instrument shaft, coupled to the optical tracker according to any one of claims 1 to 19, Portable surgical instruments.

21. A tracker for a handheld surgical instrument having an instrument shaft, A tracker frame including a mounting body that defines a device engagement opening having a longitudinal axis, , protruding parallel to the longitudinal axis, and rotating the tracker frame along the instrument axis. It includes a mounting projection that can engage with the surgical instrument to allow restraint, and the instrument engagement opening is The region is bisected by a plane parallel to the longitudinal axis, defining a first region and a second region. The tracker frame, Multiple LEDs are coupled to the tracker frame and arranged around the longitudinal axis. A emitter, wherein a first number of the plurality of LED emitters is located in the first region. The second number of the plurality of LED emitters is positioned in the second region. To reduce interference with the surgical instruments, a plurality of L, where the first number is greater than the second number. ED emitter and, A tracker equipped with this feature.

22. The tracker frame is supported by the mounting body and positioned in the first region. The offset body further includes an offset body, the offset body having a distal end coupled to the mounting body The tracker according to claim 21, which protrudes proximally to the proximal end.

23. The proximal end of the offset body is spaced apart from the longitudinal axis of the offset body. The tracker according to claim 22, wherein the tracker is spaced at a distance greater than the distance from the distal end.

24. The offset body is tapered from the distal end to the proximal end, claim 22 or This is the tracker described in 23.

25. The plurality of LED emitters emit light in succession, any one of claims 21 to 24 Tracker as described.

26. The plurality of LED emitters are arranged to form at least two arrays, and each The Ray includes at least three LED emitters, as described in any one of claims 21 to 25. The tracker.

27. Each of the at least two arrays includes a circuit board, and the plurality of LED emitters At least three of the above are attached to the circuit board, and the circuit boards are not relative to each other. The tracker according to claim 26, which is parallel.

28. The at least two arrays are arranged radially around the longitudinal axis, and the LE The D emitter emits infrared light radially in a 360-degree radius around the longitudinal axis. The tracker according to claim 26 or 27.

29. At least a portion of the two arrays is positioned on the offset body. The tracker according to claim 26 or 27, which is positioned proximal to the mounting body.

30. The tracker frame comprises a polymer or titanium, any one of claims 21 to 29 Optical tracker as described above.

31. A coupling channel is defined in the mounting body, and the mounting body is positioned in the coupling channel. It further includes two elastic arms, each having a reference end and a movable end, and the elastic arms The parts cooperate to define the device engagement opening, as described in any one of claims 21 to 30. Tracker.

32. A single unit coupled to the tracker frame and electrically communicating with the plurality of LED emitters The system further comprises a switch for use, the single-use switch including removable insulating material. or the tracker according to any one of claims 21 to 31.

33. Three radial portions of equal proportion are defined around the longitudinal axis, The multiple LED emitters are collectively enclosed, and the multiple LED emitters are at least six LED emitters. As defined therein, the at least six LED emitters are the at least six LED emitters At least one of the emitters is positioned within each radial portion. or the tracker according to any one of claims 21 to 32.

34. A handheld instrument having a shaft and coupled to a tracker according to any one of claims 21 to 33. Chi-type surgical instruments.

35. Tracker for handheld surgical instruments having a proximal end spaced apart from the distal end along the instrument axis. And, A tracker frame formed from a polymer and defining an instrument engagement opening, front The device engagement opening defines a longitudinal axis, and the longitudinal axis of the device engagement opening is the device It is configured to slidably engage with the surgical instrument so as to be aligned with the shaft, The tracker frame is rotatably fixed to the surgical instrument, and the tracker frame is... Multiple infrared emitters electrically connected to the power supply and coupled to the tracker frame. The radiation intensity of each of the infrared emitters is 40 microwatts per steradian. A tracker comprising multiple infrared emitters, each having a value of less than (μW / sr).

36. A tracker for handheld surgical instruments, A tracker frame including a mounting body that defines an appliance engagement opening, wherein the appliance engagement opening The part defines the longitudinal axis, and the tracker frame is in the longitudinal direction of the device engagement opening. The shaft is configured to slidably engage with the surgical instrument so that it is aligned with the instrument shaft. The tracker frame, At least four infrared emitters coupled to each of the tracker frames, Note: At least four infrared emitters are arranged to form a 3D volume, and the 3 The D volume is a tetrahedron, with at least four infrared emitters, A tracker equipped with this feature.

37. An optical tracker for a handheld surgical instrument having an instrument shaft, A tracker frame including a mounting body that defines an appliance engagement opening, wherein the appliance engagement opening The part defines the longitudinal axis, and the tracker frame is in the longitudinal direction of the device engagement opening. The shaft is configured to slidably engage with the surgical instrument so that it is aligned with the instrument shaft. The tracker frame is constructed, Multiple optical markers coupled to the tracker frame, Equipped with, The optical tracker is a first array that includes at least three of the plurality of optical markers. (i) is defined, and the at least three optical markers define the first region, The optical tracker includes a second array containing at least three of the plurality of optical markers. (i) further defines the at least three optical markers that define the second region. The optical tracker includes a third array containing at least three of the plurality of optical markers. (i) further defines the at least three optical markers that define the third region, and the third The region is equal to the second region described above. The first array, the second array, and the third array are arranged along the longitudinal axis and Arranged to define a tetrahedron shape having one intersecting edge and one face, The vertices of the tetrahedron-like shape are spaced apart from the longitudinal axis. Optical tracker.

38. The at least three optical markers of the first array are the at least three optical markers of the second array An optical tracker according to claim 37, which is different from at least three optical markers.

39. The at least three optical markers of the first array are the at least three optical markers of the third array An optical tracker according to claim 38, which is different from at least three optical markers.

40. The at least three optical markers of the second array are the at least three optical markers of the third array An optical tracker according to claim 39, which is different from at least three optical markers.

41. A handheld surgical instrument with a tracking mechanism, comprising a body extending along the instrument axis between the proximal and distal ends. , comprising a flexible supply cable connected to the main body and protruding from the proximal end, The flexible supply cable is curved away from the handheld surgical instrument at a distance equal to the bending radius of the cable. In a tracking handheld surgical instrument configured to do so, A tracker frame including a mounting body that defines an appliance engagement opening, wherein the appliance engagement opening The part defines the longitudinal axis, and the tracker frame is in the longitudinal direction of the device engagement opening. The proximal part of the body of the handheld surgical instrument is positioned so that the shaft is aligned with the instrument shaft. Configured to engage slidably at the ends, with three radial portions of equal proportions in the longitudinal direction Defined around an axis, collectively enclosing the longitudinal axis, and the proximal end of the tracker frame However, the handheld surgical instrument is separated at the proximal end, and the tracker frame is separated at the proximal end. The flexible supply cable is designed so that the terminal end of the flexible supply cable does not come into contact with the flexible supply cable A tracker frame positioned relative to the rudder, At least six optical markers coupled to the tracker frame, the least Each of the six optical markers is positioned so that at least one of them is located within each radial portion. Positioned, at least two of the at least six optical markers are held At least six optical markers are positioned proximal to the proximal end of the surgical instrument, A handheld surgical instrument with tracking capabilities.

42. The proximal end of the tracker frame is located in only one of the three radial portions. The trackable handheld surgical instrument as defined in claim 41.

43. The tracker frame is supported by the mounting body and is oriented parallel to the longitudinal axis. Claim 41 further includes an offset body extending to the proximal end of the tracker frame. Or, the trackable handheld surgical instrument described in section 42.

44. The proximal end of the handheld surgical instrument is positioned proximal to the proximal end of the mounting body. A trackable, handheld surgical instrument according to claim 43.

45. The tracker frame is connected to the mounting body and radiates outwards from the longitudinal axis. The mounting projection is further positioned at a single location along the axis of the device. The surgical instrument is configured to index and engage with the surgical instrument, as described in any one of claims 41 to 44. A portable, trackable surgical instrument.

46. An optical tracker for surgical instruments, A tracker frame including a mounting body that defines an appliance engagement opening, wherein the appliance engagement opening The section defines the longitudinal axis, and the tracker frame is positioned such that the longitudinal axis is aligned with the instrument axis. A tracker frame is configured to be attached to the surgical instrument in the attached state, It is coupled to the tracker frame and arranged to form at least three arrays. A set of at least nine optical markers, each array comprising the at least nine optical markers It includes at least three of the markers, and the at least three optical markers of each array are the same At least nine optical markers configured to emit light in the same direction, A single-use switch and battery electrically communicate with the at least nine optical markers. Ri and, Equipped with, Each of the three arrays is oriented to emit light in different directions from each other. Optical tracker.

47. The at least three arrays emit light at an angle of at least 260 degrees around the longitudinal axis. The optical tracker described in claim 46.

48. The single-use switch includes removable insulating material, as described in claim 46 or 47. Optical tracker.

49. A method for calibrating a surgical tracking array using a localizer, The tracking array has a first tracking surface and a second tracking surface that are coupled to each other, The first tracking surface and the second tracking surface collectively include a plurality of optical tracking elements, The aforementioned method, The plurality of optical tracking elements on the first tracking surface and the second tracking surface are localized The steps include positioning the tracking array so that it is visible to the, While the plurality of optical tracking elements are visible to the localizer, the plurality of optical tracking elements The steps include measuring the relative position of the raw materials, While the plurality of optical tracking elements are visible to the localizer, the plurality of optical tracking elements Steps include detecting the original opposing direction, Based on the measured relative positions and opposing directions of the plurality of optical tracking elements, The step of grouping a number of optical tracking elements into a first rigid body and a second rigid body, Each of the first rigid body and the second rigid body includes at least one tracking element, Steps for dividing into groups, The first tracking surface has at least one optical tracking element and the second tracking surface has at least one optical tracking element At least one optical tracking element is visible to the localizer at the same time, the tracking element A step of positioning I, At the same time, while visible to the localizer, the at least one of the first tracking surfaces The relative position of at least one optical tracking element between the optical tracking element and the second tracking surface is measured. The steps to take, While simultaneously visible, the first rigid body, the second rigid body, and the first tracking surface at least one optical tracking element and the at least one optical tracking element of the second tracking surface The steps include creating a composite rigid body based on the measured relative positions of the trace elements, Methods that include...

50. Steps include storing the manufacturing dimensions of the tracking array in the memory device of the navigation system. The manufacturing dimensions are determined by the geometric data of the first tracking surface and the geometry of the second tracking surface. A storage step including a first set of geometric data including target data, The first set of geometric data, the measured relative position of the plurality of optical tracking elements Based on the position and the detected opposing directions of the plurality of optical tracking elements, the tracking array Steps to identify, The method according to claim 49, further comprising:

51. The geometric data of the first tracking surface is obtained from the plurality of optical tracking elements of the first tracking surface. The expected relative position and the expected opposing directions of the plurality of optical tracking elements on the first tracking surface are shown. Includes, The geometric data of the second tracking surface is obtained from the plurality of optical tracking elements of the second tracking surface. The expected relative position and the expected opposing directions of the plurality of optical tracking elements on the second tracking surface are shown. The method according to claim 50, including a data.

52. The identification step involves the detected opposing direction of the plurality of optical tracking elements and the The expected opposing directions of the plurality of optical tracking elements on the first tracking surface, and the second tracking surface Claim 51 includes the step of comparing the predicted opposing directions of a plurality of optical tracking elements. The method.

53. The step of displaying a calibration command based on the step of identifying the tracking array further includes The method according to any one of claims 50 to 52.

54. The step of displaying the calibration command involves the at least one optical tracking on the first tracking surface. The tracking element and at least one optical tracking element of the second tracking surface simultaneously with the local To make it visible to the user, rotate the tracking array relative to the localizer. The method according to claim 53, further comprising the step of displaying graphics shown in the browser.

55. By associating the composite rigid body with a medical device, the tracking array is assigned to the medical device. The method according to any one of claims 49 to 54, further comprising the step of hitting.

56. The medical device is identified by associating the composite rigid body with the medical device. The method according to claim 55, further comprising a top.

57. The first tracking surface and the second tracking surface are mirror images of each other, according to any of claims 49 to 56. Choose one of the following methods.

58. The tracking array further includes a third tracking surface, the first tracking surface, the second tracking surface, and the third tracking surface collectively includes the plurality of optical tracking elements, The aforementioned method, The plurality of optical tracking elements on the third tracking surface are visible to the localizer, The steps include positioning the tracking array, Based on the measured relative positions and opposing directions of the plurality of optical tracking elements, The steps involve grouping a number of optical tracking elements into a third rigid body, While visible to the localizer, the at least one optical tracking of the first tracking surface Tracking element or at least one optical tracking element of the second tracking surface and the third tracking surface A step of measuring the relative position of at least one optical tracking element, The first rigid body, the second rigid body, and the third rigid body, and the first track At least one optical tracking element on the surface, the at least one optical tracking element on the second tracking surface The element and the measured phase of the at least one optical tracking element of the third tracking surface The steps include creating a composite rigid body based on its relative position, A method according to any one of claims 49 to 57, including the method described above.

59. The method according to any one of claims 49 to 58, wherein the optical tracking element is a reflective element.

60. The optical tracking element is an infrared light-emitting diode, as described in any one of claims 49 to 59. Method of loading.

61. By positioning a part of a medical device at a known reference position, the part of the medical device and Any one of claims 49 to 60 further includes the step of determining the positional relationship with the composite rigid body. One method.

62. The method according to claim 61, wherein the reference position is a known position on a traceable calibration device. 。

63. Claims 49 to 49 further include the step of binding the tracking array to a medical device or a patient. A method according to any one of 62.

64. A system for navigating medical devices, Localizer and, A tracking array having a first tracking surface and a second tracking surface coupled to each other, the The first tracking surface and the second tracking surface collectively include a plurality of optical tracking elements, forming a tracking array. and, Processor and Equipped with, The aforementioned processor, While the plurality of optical tracking elements are visible to the localizer, the plurality of optical tracking Measuring the relative position of elements, While the plurality of optical tracking elements are visible to the localizer, the plurality of optical tracking Detecting the opposing direction of elements, Based on the measured relative positions and opposing directions of the plurality of optical tracking elements, The 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 includes at least one tracking element, group To delete, At the same time, while visible to the localizer, at least one of the first tracking surfaces The relative position of the optical tracking element and at least one optical tracking element of the second tracking surface is measured. To determine, While simultaneously visible, the first rigid body, the second rigid body, and the first track At least one optical tracking element of the surface and the at least one optical of the second tracking surface Based on the measured relative positions of the tracking elements, a composite rigid body is created, A system configured to perform the following actions.

65. A method for calibrating a surgical tracking array using a localizer, The tracking array has a first tracking surface and a second tracking surface that are coupled to each other, The first tracking surface and the second tracking surface collectively include a plurality of optical tracking elements, The aforementioned method, The plurality of optical tracking elements on the first tracking surface and the second tracking surface are localized The steps include positioning the tracking array so that it is visible to the, While the plurality of optical tracking elements are visible to the localizer, the plurality of optical tracking elements The steps include measuring the relative position of the raw materials, The first tracking surface has at least one optical tracking element and the second tracking surface has at least one optical tracking element At least one optical tracking element is visible to the localizer at the same time, the tracking element A step of positioning I, At the same time, while visible to the localizer, the at least one of the first tracking surfaces The relative position of at least one optical tracking element between the optical tracking element and the second tracking surface is measured. The steps to take, At the same time, while visible, at least one optical tracking element of the first tracking surface and the Based on the measured relative position of the at least one optical tracking element on the second tracking surface , the step of creating a composite rigid body, Methods that include...

66. An optical tracker for surgical instruments, Includes an attachment body configured to be attached to the surgical instrument, and is made of polymer. Lacquer frame and, It is coupled to the tracker frame and arranged to form at least two arrays. A set of at least six optical markers, each array comprising the at least six optical markers It includes at least three of the markers, and the at least three optical markers of each array are the same At least six optical markers configured to emit light in the same direction, A battery electrically connected to the at least six optical markers, Equipped with, Each of the three arrays is oriented to emit light in different directions from each other. Optical tracker.

67. An optical tracker for surgical instruments, A tracker frame including a mounting body that defines an appliance engagement opening, wherein the appliance engagement opening The section defines the longitudinal axis, and the tracker frame is positioned such that the longitudinal axis is aligned with the instrument axis. A tracker frame is configured to be attached to the surgical instrument in the attached state, It is coupled to the tracker frame and arranged to form at least three arrays. A set of at least nine optical markers, each array comprising the at least nine optical markers It includes at least three of the markers, and the at least three optical markers of each array are the same At least nine optical markers configured to emit light in the same direction, Equipped with, Each of the three arrays is oriented to emit light in different directions from each other. Re, Two of the at least three arrays are the positions of the at least three optical markers. An optical tracker configured such that its surface becomes a mirror surface around the aforementioned longitudinal axis.

68. An optical tracker for surgical instruments, A trap comprising a first part and a second part defining the device engagement portion, further comprising a polymer Kaframe and, A minimum number of elements coupled to the first portion of the tracker frame and defining the first array A first circuit board containing at least three LEDs, A small number of elements coupled to the second portion of the tracker frame and defining the second array A second circuit board including at least three LEDs, wherein the first array is the second array A second circuit board, oriented to emit light in a different direction from Ray, A battery electrically coupled to the first circuit board and the second circuit board, Equipped with, The aforementioned optical tracker does not have a communication interface.

69. The optical tracker according to claim 68, wherein the battery is a coin cell battery.

70. The optical transistor according to claim 68 or 69, wherein the battery has a mass of less than 5 grams. Okay.

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