WO2025088575A1 - Système et méthode de navigation - Google Patents
Système et méthode de navigation Download PDFInfo
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- WO2025088575A1 WO2025088575A1 PCT/IB2024/060536 IB2024060536W WO2025088575A1 WO 2025088575 A1 WO2025088575 A1 WO 2025088575A1 IB 2024060536 W IB2024060536 W IB 2024060536W WO 2025088575 A1 WO2025088575 A1 WO 2025088575A1
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- WIPO (PCT)
- Prior art keywords
- tracking device
- instrument
- pose
- field
- relative
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00681—Aspects not otherwise provided for
- A61B2017/00725—Calibration or performance testing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
- A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
- A61B2034/2046—Tracking techniques
- A61B2034/2051—Electromagnetic tracking systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0807—Indication means
- A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
Definitions
- the subject disclosure is related generally to a tracking and navigation system, and particularly to tracking using an electromagnetic field and related sensor.
- An instrument can be navigated relative to a subject for performing various procedures.
- the subject can include a patient on which a surgical procedure is being performed.
- an instrument can be tracked in a physical space which may also be referred to as an object or subject space.
- the subject space can be a patient space defined by a patient. The location of the instrument that is tracked can be displayed on a display device relative to an image of the patient.
- the position of the patient can be determined with a tracking system.
- a patient is registered to the image, via tracking an instrument relative to the patient to generate a translation map between the subject or object space (e.g., patient space) and the image space.
- This often requires a user, such as a surgeon, to identify one or more points in the subject space and correlating, often identical points, in the image space.
- the position of the instrument can be appropriately displayed on the display device while tracking the instrument.
- the position of the instrument relative to the subject can be displayed as a graphical representation, sometimes referred to as an icon on the display device.
- an imaging system may be used to acquire image data of a subject.
- the imaging system may include an ultrasound imaging system that includes an ultrasound (US) probe that generally includes an ultrasound transducer to emit and receive ultrasound frequencies. It is understood, however, that the imaging system may include separate components that emit and receive ultrasound frequencies.
- a tracking system such as a tracking system that emits an electromagnetic field, may be used to track one or more tracking devices.
- the tracking devices may be positioned on instruments (which may include procedure instruments, imagers, or other members) and tracked in a physical space also referred to as a patient space.
- the position of the tracking device and an instrument with which it is associated may be displayed in an image representing the subject. For example, the determined position may be superimposed on a portion of the image.
- An electromagnetic (EM) field may be emitted by an emitter or transmitter and may be sensed by an electromagnetic sensing device of the tracking device.
- the electromagnetic sensing device may include one or more coils of a conductive material or may include other sensors including but not limited to Hall effect, flux gate, magneto-resistive, tunnel junction, optical, microelectromechanical systems (MEMS), magneto-optical, sensors or may include combinations thereof.
- Various other materials such as conductive, magnetic, or conductive and magnetic materials, may interfere with a field being sent by the sensor. The interference with the field that is sensed by the sensor, however, may be quantified and analyzed to determine the position or orientation or subsets of such degrees of freedom of a portion that is interfering with the field.
- a navigation system may be used to register or after an image is registered to a navigation space. Thus a pose of a tracked portion or member may be displayed relative to an image. Also, systems may be used where a patient is not registered to an image but where an imaging device is tracked so that a pose of the acquired image data and related image are tracked.
- a sensor may be positioned relative to an object that is an interfering object.
- the interfering object may be moved relative to the sensor and where related distortion may be measured in the sensed field.
- a metric may be used to determine the amount of distortion. Metrics may include geometry determination and/or phase shift determinations.
- the position of the interfering object may be characterized by the metric being used to measure the distortion. The value of the metric may change based upon the position of the distorting or interfering object. Therefore, even if a tracking device is not attached directly to an interfering object, a position of the interfering objection may be characterized and determined relative to the tracking device including an EM field sensor in a volume. Therefore, the position of the interfering object may be determined relative to an instrument portion including the tracking device.
- FIG. 1 is diagrammatic view illustrating an overview of a robotic system and a navigation system, according to various embodiments
- FIG. 2 is a schematic illustration of an instrument having at least a first portion and a second portion, according to various embodiments;
- FIG. 3 is a detailed schematic view of the instrument to Fig. 2 positioned in a portion of a subject;
- FIG. 4 is a schematic illustration of an instrument having two portions moveable in one degree of freedom in a first configuration
- FIG. 5A is a schematic illustration of the instrument of Fig. 4 having two portions in a second configuration
- FIG. 6A is a schematic illustration of the instrument of Fig. 4 having two portions in a third configuration, according to various embodiments;
- FIG. 7 is a schematic illustration of an instrument having at least first and second portions moveable in two degrees of freedom in a first configuration, according to various embodiments;
- Figs. 8A and 8B are schematic illustrations of the instrument of Fig. 7 in a second configuration;
- FIGs. 9A and 9B are schematic illustrations of the instrument of Fig. 7 in a third configuration
- FIG. 10 is a schematic illustration of an instrument in a first configuration having at least three degrees of freedom of movement of a first portion relative to a second portion, according to various embodiments;
- FIG. 11 is a schematic illustration of the instrument of Fig. 10 in a second configuration
- Fig. 12 includes a schematic illustration of various instruments in multiple configurations.
- Fig. 13 is a flowchart illustrating a process, according to various embodiments.
- a tracking system that may be used to track a selected tracking device.
- the tracking system may operate, according to various embodiments, by emitting an electromagnetic (EM) field from a localizer, also referred to as an EM localizer.
- the EM field may be emitted from one or more coils that may be oriented relative to an origin point.
- the coils may emit the field.
- the field may be a largely magnetic field.
- the field may be constant or varying in time.
- a tracking device may include one or more coils of conductive material that operate as sensors to sense the field.
- the field may generate a voltage or current within the coil of the tracking device.
- a determination of a position and orientation (also referred to collectively as a “pose”) of the tracking device may be made based on a determination of the induced voltage or current from the field. It is further understood that an EM, or any appropriate tracking system, may operate by emitting a signal (e.g., EM fields) from the tracking device and receiving signals at the localizer.
- a signal e.g., EM fields
- Various materials are conductive or conductive and magnetic, such as conductive polymers, metal or metal alloys, or other materials. Objects or items may be formed with these materials. If an item formed with these materials is also in or near the field generated by the EM localizer, a current may be formed or induced or magnetization coerced in the object.
- the object may be referred to as an interfering or target object.
- a field may also be produced.
- a field produced due to the induced current or coerced magnetization in the interfering object may also be referred to as an interfering field.
- These interfering fields may alter the field sensed by the tracking device such that it is not always sensing only the EM field generated by the EM localizer.
- the tracking device may sense both the EM field from the localizer and the EM field that is the interfering field. According to various theories, the sensed field may be a combination of both and/or the EM field from the EM localizer that is altered by the interfering field.
- a tracking system may be incorporated into a navigation system that includes one or more instruments that may be tracked relative to the subject.
- the navigation system may include one or more tracking systems that track various portions, such as tracking devices, associated with instruments.
- the tracking system may include a localizer that is configured to, alone or in combination with a processor, determine the pose of a tracking device in a navigation system coordinate system. Determination of the navigation system coordinate system may include those described at various references including U.S. Pat. No. 8,737,708; U.S. Pat. No. 9,737,235; U.S. Pat. No. 8,503,745; and U.S. Pat. No. 8,175,681 ; all incorporated herein by reference.
- a localizer may be able to track an object within a volume relative to the subject.
- the navigation volume, in which a device may be tracked may include or be referred to as the navigation coordinate system or navigation space.
- a determination or correlation between two coordinate systems may allow for or also be referred to as a registration between two coordinate systems.
- images may be acquired of selected portions of a subject.
- the images may be displayed for viewing by a user, such as a surgeon.
- the images may have superimposed on a portion of the image can include a graphical representation of a tracked portion or member, such as an instrument.
- the images may have a coordinate system and define an image space.
- the graphical representation may be superimposed on the image at an appropriate position due to registration of an image space (also referred to as an image coordinate system) to a subject space.
- a method to register a subject space defined by a subject to an image space may include those disclosed in U.S. Pat. Nos. U.S. Pat. No. 8,737,708; U.S. Pat. No. 9,737,235; U.S. Pat.
- the imaging device may be tracked so its images may be tracked in a navigation space.
- a display of tracked instruments relative to tracked images without a tracked or registered patient may occur.
- displaying tracked instruments and images relative to a tracked and registered patient may occur.
- the tracking of an instrument during a procedure allows for navigation of a procedure.
- image data When image data is used to define an image space it can be correlated or registered to a physical space defined by a subject, such as a patient as discussed herein. According to various embodiments, therefore, the patient defines a patient space in which an instrument can be tracked and navigated.
- the image space defined by the image data can be registered to the patient space defined by the patient. The registration can occur with the use of fiducials that can be identified in the image data and in the patient space.
- Fig. 1 is a diagrammatic view illustrating an overview of a procedure room or arena.
- the procedure room may include a surgical suite in which may be placed a robotic system 20 and a navigation system 26 that can be used for various procedures.
- the robotic system 20 may include a Mazor XTM robotic guidance system, sold by Medtronic, Inc.
- the robotic system 20 may be used to assist in guiding a selected instrument, such as drills, screws, etc. relative to a subject 30.
- the robotic system 20 may hold and/or move an imaging system, such as an ultrasound (US) probe 33 or 33’.
- the robotic system 20 may include a mount 34 that fixes a portion, such as a robotic base 38, relative to the subject 30.
- the robotic system 20 may include one or more arms 40 that are moveable or pivotable relative to the subject 30, such as including an end effector 44.
- the robotic arm 40 may be controlled by a selected robotic control module, which may be included with the navigation system or processor, as discussed herein, or a separate robotic control module 45.
- the robotic control module 45 may include one or more processors or memory that may communicate, execute instructions, or store instructions for operation of the robotic arm 40.
- the end effector may be any appropriate portion, such as a tube, guide, or passage member. Affixed to and/or in place of the end effector may be the imaging system that may be the US probe 33.
- the end effector 44 may be moved relative to the base 38 with one or more motors.
- the position of the end effector 44 may be known or determined relative to the base 38 with one or more encoders at one or more joints, such as a wrist joint 48 and/or an elbow joint 52 of the robotic system 20.
- One or more portions of the robotic system 20 may be formed of conductive materials.
- the navigation system 26 can be used to track the location of one or more tracking devices and/or determine and/or illustrate a pose thereof.
- Tracking devices may include a robot tracking device 54, a subject tracking device 58, an imaging system tracking device 62, an imaging system or second imaging system tracking device 81 , and/or an instrument or tool tracking device 66.
- a tool or moveable member 68 may be any appropriate tool such as a drill, forceps, catheter, or other tool operated by a user 72.
- the tool 68 may also be and/or an implant, such as a spinal implant or orthopedic implant. Further, the tool 68 may include one or more moveable portions, such as deployable portions.
- a heart valve replacement and related inserter tool that may insert the instrument 68 or selected portion, such as an implant, into a heart 127 of the subject 30 and/or any other appropriate portion of any appropriate subject.
- the navigation system 26 may be used to navigate any type of instrument, implant, or delivery system, including: guide wires, arthroscopic systems, orthopedic implants, spinal implants, deep brain stimulation (DBS) probes, etc.
- the instruments may be used to navigate or map any region of the body.
- the navigation system 26 and the various instruments may be used in any appropriate procedure, such as one that is generally minimally invasive or an open procedure.
- imaging system 80 may be used to acquire pre-, intra-, or post-operative or real-time image data of a subject, such as the subject 30. It will be understood, however, that any appropriate subject can be imaged and any appropriate procedure may be performed relative to the subject.
- the imaging system 80 comprises an 0-arm® imaging device sold by Medtronic Navigation, Inc. having a place of business in Colorado, USA.
- the imaging system 80 may have a generally annular gantry housing 82 in which an image capturing portion is moveably placed and/or enclosed.
- the imaging system 80 can include those disclosed in U.S. Pat. Nos.
- the imaging system 80 can know its position relative to the patient 30 or other references.
- the precise knowledge of the position of the image capturing portion can be used in conjunction with a tracking system to determine the position of the image capturing portion and the image data relative to the tracked subject, such as the patient 30.
- the imaging system tracking device 62, 81 may be used and/or operable to determine a pose of the imaging system 33, 80 at a selected time such as during image data acquisition.
- the position of the imaging system may be used for registration of an image space or coordinate system to a patient space or coordinate space.
- the robotic system may also be registered to one or more spaces or coordinate systems such as by the system and method as disclosed in U.S. Pat. No. 11 ,135,025, incorporated herein by reference.
- More than one tracking system can be used to track the instrument 68 or other portion, such as the US probe 33 with the tracking device 81 in the navigation system 26.
- these can include an electromagnetic tracking (EM) system having the EM localizer 94 and/or an optical tracking system having the optical localizer 88.
- EM electromagnetic tracking
- optical tracking system having the optical localizer 88.
- Either or both of the tracking systems can be used to track selected tracking devices, as discussed herein. It will be understood, unless discussed otherwise, that a tracking device can be a portion trackable with a selected tracking system.
- a tracking device need not refer to the entire member or structure to which the tracking device is affixed or associated.
- Image data acquired from the imaging system 33 can be acquired at and/or forwarded from an image device controller 96, that may include a processor module, to a navigation computer and/or processor module (also referred to as a processor) 102 that can be a part of a controller or work station 98 having the display 84 and a user interface 106. Further, a memory system or module 103, of any appropriate type, may be accessed by the processor 102. It will also be understood that the image data is not necessarily first retained in the controller 96, but may also be directly transmitted to the work station 98.
- the work station 98 can provide facilities for displaying the image data as an image 108 on the display 84, saving, digitally manipulating, or printing a hard copy image of the received image data.
- the user interface 106 which may be a keyboard, mouse, touch pen, touch screen or other suitable device, allows the user 72 to provide inputs to control the imaging device 80, 33, via the image device controller 96, or adjust the display settings of the display 84.
- the work station 98 may also direct the image device controller 96 to adjust the image capturing portion of the imaging device 80 to obtain various two-dimensional images along different planes in order to generate representative two- dimensional and three-dimensional image data.
- the navigation system 26 can further include the tracking system including either or both of the electromagnetic (EM) localizer 94 and/or the optical localizer 88.
- the tracking systems may include a controller and interface portion 110.
- the controller 110 can be connected to the processor portion 102, which can include a processor included within a computer.
- the EM tracking system may include the STEALTHSTATION® AXIEMTM Navigation System, sold by Medtronic Navigation, Inc. having a place of business in Louisville, Colorado; or can be the EM tracking system described in U.S. Patent Application Serial No. 10/941 ,782, filed Sept. 15, 2004, and entitled "METHOD AND APPARATUS FOR SURGICAL NAVIGATION"; U.S. Patent No.
- the navigation system 26 may also be or include any appropriate tracking system, including a STEALTHSTATION® TREON®, S7TM , S8TM tracking systems having an optical localizer, that may be used as the optical localizer 88, and sold by Medtronic Navigation, Inc. of Colorado.
- Other tracking systems include an acoustic, radiation, radar, etc. The tracking systems can be used according to generally known or described techniques in the above incorporated references. Details will not be included herein except when to clarify selected operation of the subject disclosure.
- Wired or physical connections can interconnect the tracking systems, imaging device 80, etc.
- various portions such as the instrument 68 may employ a wireless communications channel, such as that disclosed in U.S. Patent No. 6,474,341 , entitled “Surgical Communication Power System,” issued November 5, 2002, herein incorporated by reference, as opposed to being coupled directly to the controller 110.
- the tracking devices 62, 66, 54 can generate a field and/or signal that is sensed by the localizer(s) 88, 94.
- the instrument can also include more than one type or modality of tracking device 66, such as an EM tracking device and/or an optical tracking device.
- the instrument 68 can include a graspable or manipulable portion at a proximal end and the tracking devices may be fixed near the manipulable portion of the instrument 68.
- the navigation system 26 may be a hybrid system that includes components from various tracking systems.
- the navigation system 26 can be used to track any appropriate portion such as the US probe 33 and/or the instrument 68 relative to each other or the patient 30.
- the instrument 68 can be tracked with the tracking system, as discussed above.
- Image data of the patient 30, or an appropriate subject can be used to assist the user 72 in guiding the instrument 68.
- the image data may or may not be registered to the patient 30.
- the US probe 33 is tracked and generates the image data.
- the image data need not be registered to the subject to display a pose of the tracked instrument 68 relative to the image data generator with the tracked US probe 33.
- the image data defines the image space that is registered to the patient space defined by the patient 30.
- the registration can be performed as discussed herein, automatically, manually, or combinations thereof.
- the registration can include the process and the final transformation (including a translation and rotation) map.
- registration includes determining points in the image data and the subject space and determining a transformation map therebetween. Once done, the image space are registered to the subject space, or any two or more coordinate spaces.
- registration also allows a transformation map to be generated of a tracked physical pose of the instrument 68 relative to the image space of the image data.
- the transformation map allows the tracked position of the instrument 68 to be displayed on the display device 84 relative to the image data 108.
- the graphical representation 68i also referred to as an icon, can be used to illustrate the location of the instrument 68 relative to the image data 108.
- a subject registration system or method can use the tracking device 58.
- the tracking device 58 may include portions or members 120 that may be trackable, but may also act as or be operable as a fiducial assembly.
- the fiducial assembly 120 can include a clamp or other fixation portion 124 and the imageable fiducial body 120. It is understood, however, that the members 120 may be separate from the tracking device 58.
- the fixation portion 124 can be provided to fix any appropriate portion, such as a portion of the anatomy.
- the fiducial assembly 120 can be interconnected with a portion of a spine 126 such as a spinous process 130.
- the fixation portion 124 can be interconnected with a spinous process 130 in any appropriate manner.
- a pin or a screw can be driven into the spinous process 130.
- the tracking device 58 may be operable to track with one or more tracking systems or modalities, such as EM tracking system or optical tracking system.
- the imaging device 33 may include the US probe 33 that may be positioned relative to the subject 30, such as by the robotic system 20 and/or the surgeon 72.
- the surgeon 72 may operate the robotic arm 20 and/or hold the US probe 33 separate therefrom.
- the robotic system 20 may move the US probe 33 to a selected position relative to the subject 30.
- the imaging system may be positioned relative to the subject in any appropriate manner.
- Determination of a position of an object may be performed in any appropriate manner. Further, positions of various portions relative other tracking device may also be determined. According to various embodiments, a pose of an interfering object (which may be conductive) may be determined relative to a tracking device within an EM navigation coordinate system particularly when an EM field is emitted and distorted relative to a interfering item that may generate or emit fields in light of induced currents or coerced magnetizations in the item.
- the instrument 68 may be any appropriate instrument, and as discussed herein may include an instrument that may be used in various procedures.
- the instrument 68 may include an inserter or guided catheter 200, as illustrated in Figs. 2-6B.
- the instrument 200 may be used in addition to and/or as the instrument 68. Therefore, discussion of the instrument 200 may include all the features identified above relative to the instrument 68, such as tracking and illustration of a pose of the instrument 68 relative to the selected image data, such as with the graphical representation 68i.
- the instrument 200 may include various portions that allow the instrument 200 to be used relative to the subject 30.
- the instrument 200 may include a handle 202 that may include various portions, such as guiding or directing portions 204 that may cause a catheter or extension portion 208 of the instrument 200 to bend or move relative to an axis 210 of the handle 202.
- the instrument 200 may include one or more extendable portions, such as a capsule 212 that may move, such as axially, relative to a distal tip 214 of the extension portion 208.
- the capsule portion 212 may extend or be moved along an axis 216 that may be extend or be defined by the distal portion 214 of the catheter portion 208.
- the catheter portion 208 may be moved within the subject 30 for a selected procedure.
- the directing portions 204 on the handle 202 may be used to bend or move the catheter portion 208 to direct an angle or turn of the distal end 214.
- the tracking device 66 may be positioned at or near the distal tip 214 of the catheter portion 208. According to various embodiments, the tracking device 66 may be connected (e.g., fixed) to the catheter portion 208, such as at the distal tip 214. Accordingly, the tracking device 66 may be used to track a pose of at least the distal tip 214 of the catheter portion 208. As discussed above, however, as the capsule 212 moves away from the distal tip 214, a specific pose of the capsule may not be directly known due to the tracked pose of the tracking device 66. As discussed herein, the capsule 212 may be proximate, including in contact with, the distal tip 214.
- the tracked pose of the tracking device 66 may be used to know directly the pose of the capsule 212 when proximate the distal tip 214.
- the capsule 212 may move away from and/or be remote from the distal tip 214.
- the tracked pose of the tracking device may not be used to directly know the pose of the capsule 212.
- a metric may be measured at or with the tracking device 66.
- the capsule 212 may include at least a portion and/or be entirely formed of an interfering material (which may be a conductive material)
- the interfering material of the capsule 212 may have currents induced to therein due to the EM field generated by the EM localizer 94.
- the induced currents in the capsule 212, including in the conductive material thereof, may generate fields that are emitted from the capsule 212.
- the fields emitted from the capsule 212 may affect the tracking device 66 and/or the fields sensed by the tracking device 66.
- induced fields The fields emitted by the induced currents in the capsule 212 may be referred to as induced fields.
- a pose of the capsule 212 may be determined relative to the subject 30 at least based upon the induced fields sensed at the tracking device 66 and the tracked pose of the tracking device 66.
- the instrument 200 including the catheter portion 208 may be positioned within a selected portion of the subject 30, such as a heart 127.
- the instrument 200 may be used to position selected implant, such as a valve replacement 224.
- the valve assembly 224 may be any appropriate valve assembly and/or any appropriate implant, that may be positioned within an appropriate subject, such as the patient 30.
- the Intrepid TM transcatheter mitral valve replacement system a valve replacement under investigation by Medtronic, Inc., having a place of business in Minneapolis, Minnesota.
- the instrument 200 may be a catheter use to provide or move the implant into a selected location, such as at or near a mitral valve 226 of the subject within the heart 127.
- the instrument 200 including the catheter portion 208, may include a first portion 230 and a second portion 234.
- the two portions 230, 234 may move relative to one another, as illustrated in Fig. 3.
- the tracking device 66 may be positioned nearthe distal tip 214 of the second portion 234. Therefore, the tracking device 66 may be used to track a pose of the distal tip 214 of the instrument 200.
- the pose of the tracking device 66 may be used to determine or understand the position of the capsule 212 as the capsule 212 is at a fixed position relative to the distal end 214.
- the capsule 212 may be moved remote from the distal tip 214 such as relative to a piston 238.
- the piston 238 may seal relative to an interior wall 239 of the capsule 212.
- a fluid may be moved or forced through a tube (also referred to as a movement member) 242 that may extend from the distal end 214.
- the tube 242 may be generally rigid such that it extends along an axis 244 that is generally perpendicular to a face plane 246 of the distal end 214 of the catheter portion 208.
- the capsule 212 may be sealed at a distal end such that as fluid is forced past the piston 238 the capsule with will move along the axis 244.
- the capsule 212 may move axially relative to the distal end 214, such as generally in one degree to freedom along the axis 244.
- the capsule 212 may be affected by fields emitted by the EM localizer 94.
- Currents may be induced in the capsule 212 (such as in the conductive portions thereof) and one or more fields, such as represented by field lines 250 may be generated due to the induced currents in the capsule 212.
- the induced field 250 may affect or be sensed by the tracking device 66.
- the piston 238 may move relative to the distal end 214 of the instrument 200 due pressure of a fluid moving through the tube 242 and past the piston 238 to move the capsule 212 relative to the distal end 214.
- the piston 238 stays stationary with respect to 214 and the fluid pushes the capsule 212 out along linear dimension 250 relative to the piston 238 the end 214 and the tracker 66.
- the capsule 212 is configured and able to move relative to the tracking device 66 which is fixed to the insertion portion 208 of the instrument 200.
- the dimension 250 of the capsule 212 may also relate to and/or be the dimension of the distal point 254 of the capsule 212 from the tracking device 66.
- the induced eddy current 264 may, therefore, be known and/or predetermined such that the interfering field 268 may also be known that is sensed by the tracking device 66.
- the point 254 that may move with the capsule 212 may move relative to a distal end point to 270 that may be at a distal end of the piston 238. In the initial position, such as when the capsule 212 is contacting the extension portion 208, the distal point 270 of the piston may be substantially coextensive with the distal point 254 of the capsule 212. Nevertheless, as the capsule 212 moves, the distal point 254 moves away from the distal point 270 of the piston 238.
- the geometry of the tracking device 66 may be determined.
- the geometry may be measured to be substantially equilateral, as illustrated in the tracking device 66.
- a measured or determined tracking device 66Z1 may be determined.
- the tracking device that is measured 66Z1 may have each of the coils measured, such as a first measured coil 280', as a second measured coil 284', and a third measured coil 288'.
- the measured or determined distances between each of the coils may not be the equilateral distances but may be other distances such as a first measured distance 290' between the first measured coil 280’ and the second measured coil 284’, a second measured distance 292' between the first measured coil 280’ and the third measured coil 288’, and a third measured distance 294' between the second measured coil 284’ and the third measured coil 288’.
- the different distances may be the metric that is measured.
- the three distances or orientation of the coil may be measured and compared to a predetermined measurement that is based upon a predetermined distance of the capsule 212.
- the predetermined measurements of the metric and the related predetermined post of the capsule 212 (such as a distance from the tracking device 66) may be saved in a memory module. Therefore, the geometry of the measured tracking device 66Z1 , as illustrated in Fig. 5B for example, may relate to the distance 258 as illustrated in Fig. 5A. Therefore, if a measured geometry of the tracking device 66Z1 is measured during a procedure, the distance 258 may be determined, such as via the lookup table. The determined distance 258 may be based upon a lookup table of a predetermined distance 258 and the predetermined measured geometry 66Z1. Therefore, the displayed icon or graphical representation of the device 68i may illustrate the dimension 258 of the capsule 212.
- the capsule 212 may continue to move in the direction of the arrow 253 relative to the piston 238. Again, the terminal or distal point 254 of the capsule may move relative to the distal point 270 of the piston 238. As illustrated in Fig. 6A, the implant 224 may be completely released from the capsule 212. The capsule 212 may therefore be at a second position such that the distal end 256 is a distance 300 from the distal end 214 of the catheter portion 208. Again, the tracking device 66 may be positioned or fixed to the distal end 214.
- the capsule 212 may still be affected by emitted fields from the EM localizer 94 such that the current 264 is induced therein which further generates the induced field 268.
- the induced field 268 may still affect the tracking device 66.
- the induced field 268 may have a different strength, orientation, or the like relative to the tracking device 66 when the distance 300 of the capsule 212 exists. Therefore, the sensed field may be a slightly changed field 268' as illustrated in Fig. 6A.
- the tracking device 66 may have a known and fixed geometry of various tracking coils or portions 280-288, as illustrated in Fig. 6B. Due to the slightly changed field 268', however, a sensed or measured tracking device 66Z2 may be measured.
- the measured coils 280", 284" and 288" may have the metric defined relative to them measured. Distances between these may include a first distance 290", a second distance 292", and a third distance 294". These three distances 290"-294" may also be predetermined based upon the distance 300 of the capsule 212 in the field emitted by the EM localizer 94. Therefore, again, when the measured tracking device 66Z2 is measured, a lookup table may be used to determine a dimension or the position of the capsule 212, which may be determined to have the dimension 300 relative to the distal end 214. The determined position of the capsule 212 may then be illustrated on the display device 84, such as with a graphical representation 68i.
- the tracking device 66 and the sensed field therewith may be used to determine a pose of a portion of the instrument 68 that is not directly tracked with a tracking device affixed thereto, such as the tracking device 66.
- the portion that moves relative to the tracking device 66 may affect the field emitted by the EM localizer 94 and/or generate a secondary field, such as the field 268, that may be sensed by the tracking device 66.
- a metric that is measured by the navigation system may be used to determine a pose of the movable portion, such as the capsule 212, relative to the tracking device 66.
- the metric may be used to determine a precise pose of the portion that has moved relative to the tracking device 66, particularly when the movement is limited in various dimensions.
- the capsule 212 generally moves only along the axis in the direction of the arrow 253. Therefore, the dimension of the capsule 212 relative to the distal end 214 may be determined based upon the measured metrics of the tracking device 66.
- one measured and determined geometry metric may be used to determine one distance or one degree of freedom.
- various techniques may be used to measure distorted fields and determine non-distorted fields, such as those disclosed in U.S. Pat. No. 11 ,439,317, U.S. Pat. No. 11 ,571 ,261 , U.S. Pat. App. No.
- an average tracked position and orientation of the coils may remain largely constant from configuration 66 to 66z1 to 66z2.
- the triangle plane and centroid may remain largely constant from configuration 66 to 66z1 to 66z2 so that the determined position and orientation of tracker 66 remains largely constant as capsule 212 moves away from tracker 66.
- Figs. 5A and 6A may be displayed as graphical representations on the display device 84 to illustrate the determined pose or navigated pose of various portions such as the capsule 212, the extension portion 208, the implant 224, or the like. It is also understood that the representations may relate to a real or patient space pose of the various portions, such as illustrated in Fig. 3. Accordingly, the details and schematic illustrations in Figs. 5A and 6A are exemplary illustrations of real or determined poses of the instrument 68 and portions thereof.
- the capsule 212 may be formed of a selected conductive material. For example, various steel or steel alloys may be used. Other conductive materials may also be provided in the capsule 212. Further, capsule 212 may not be made entirely of a conductive material, but may have conductive portions formed therewith. For example, the capsule 212 may be formed of a polymer material having one or more conductive members or features included therewith, such as metallic sheets or the like. Nevertheless, the conductive portions may have currents induced therein, such as the current 264, that may then emit or generate the field 268. This may allow a determination of a pose of the capsule or movable portion that does not have a tracking device relative to a tracking device, such as the tracking device 66.
- an instrument 320 is illustrated.
- the instrument 320 may be similar to the instrument 68 as discussed above save for the portions discussed herein. Accordingly, discussion of the instrument 320 may relate to and/or be incorporated into a discussion of the instrument 68 above and may include features similar thereto.
- the instrument 320 may include an extendable or catheter member 324 and a relatively movable member or capsule 326.
- the capsule 326 may be similar to the capsule 220 discussed above.
- the instrument 320 may further include the tracking device 66 dispositioned near a distal end 328 of the extendable portion 324.
- the capsule 326 may be formed or include conductive materials, such as that discussed above.
- the capsule 326 may be moved away from the distal end 328 of the catheter member 324.
- the tracking device 66 may be maintained at or near the distal end 328.
- the catheter member 324 may extend along an axis 332.
- the axis 332 may be defined or known relative to the tracking device 66.
- the axis 332 may be referred to or understood as long axis of the extendable instrument portion 324 and/or the tracking device 66.
- the capsule 326 may be moved away from the distal end 328 by an extending or pushing portion or driving portion 334.
- the extending or driving portion 334 may move or push the capsule 326 away from the distal end 328 and/or the driving portion 334 may be a tube to apply or move a fluid to move the capsule 326 away from a distal end or end of the driving member 334 as discussed above.
- the capsule 326 may be moved a distance 338 from the distal end 328.
- the distance 338 may be measured from a distal end 340 of the capsule 336 from the distal end 328 of the extendable portion 324.
- the distance 338 may be measured along the axis 332.
- the capsule 326 may be moved away from the axis 332.
- the capsule 326 may define or have an axis 344 and the capsule axis 344 may extend at an angle 348 from the axis 332. Therefore, the capsule 326 may move along an arc 352 relative to the central axis 332.
- the arc 352 may be defined by rotation of the capsule 326 relative to the central axis 332, such as the direction of arrow 356. Therefore, a pose of the capsule 326 may include at least two degrees of freedom, including the distance 338 and the angle 380 which may allow the capsule 326 to be moved in the arc at a pose relative to the tracking device 66.
- angle 348 may be considered fixed so that two degrees of freedom that may be determined may include the extension distance 338 and rotation angle 380 around arc 352. This may allow the tracking device 66 to be tracked directly by the navigation system, the pose of the capsule 326 may not be directly known by tracking the tracking device 66.
- a current may be induced in the capsule or a portion of the capsule 326.
- a representation of the current includes the current line or circle 360.
- the current may be induced in a conductive portion of the capsule 326, similar to the discussion above.
- the induced current may generate a field 364 that is emitted or generated by the induced current 360.
- the field 364 may be sensed by the tracking device 66, as discussed above.
- a metric may be measured at the tracking device or determined at the tracking device 66 to assist in determining a pose of the capsule 326 relative to the tracking device 66. Again, the metric may be any appropriate metric, such as those discussed above including a geometric change measurement metric.
- a pose of the capsule 326 may be determined by measuring the metric at the tracking device 66.
- two or more measured and determined metric components or metrics may be used to determine various measurements, such as in one instance one distance and one rotation or in another instance two degree of freedoms.
- the pose of the capsule 326 may be predetermined based upon the metric.
- the determined pose may include both the distance 338 and the angle 380.
- the angle 380 may be defined relative to the tracking device 66 as the capsule 326 rotates around the axis 332 but the tracking device 66 remains in a single position.
- the capsule 326 may be rotated relative to the axis 332 in the direction of the arrow 368. Therefore, the axis 344 of the capsule 326 may form an angle 384 around the axis 332. While the angle 370 may be similar or identical to the angle 348, the arc position relative to the tracking device 66 may be different, as illustrated in Figs. 9A and 9B relative to the arc position illustrated in Figs. 8A and 8B. Therefore, the arc position of the capsule 326 may again be determined due to the inducement of the current 360 and the field 364' generated by the induced current 360.
- the pose of the capsule 326 may be determined in at least two degrees of freedom including the arc position and a distance from the tracking device 66. Again, the determined pose of the capsule 326 may be determined in the patient space and/or illustrated with a graphical representation and image such as the supply device 84. Therefore, the determined pose of an untracked or indirectly tracked portion may be determined in at least two degrees of freedom relative to a tracking device.
- the pose of the capsule 326 when extended from the distal end 328, may include the distance 338 in both the arcuate positions illustrated in Figs. 8A and 9A.
- the arcuate position along the circle 352 may be an arc position 380 that is illustrated to be above the tracking device 66.
- the capsule 326 in an arc position 384 that is illustrated to be below the tracking device 66.
- the relative arc positions 380, 384 may be understood to be right, left, up or down of the tracking device 66 but may be predetermined or measured relative to the tracking device 66. Therefore, the respective fields 364, 364' may be based upon both the distance 338 and the arc position. Further the distance 338 may vary, similar to the various positions of the capsule 212 discussed above.
- the instrument 390 may include portions similar to those discussed above, such as an extendable portion 394 that may be moved in the selected region, the tracking device 66, that may extend along or define an axis 398. Further, the instrument 390 may include a movable or capsule member 402. The capsule 402 may extend along an axis 404. The capsule 402 may have a distal end or portion 408. The distal end 408 may be moved relative to a distal end 412 of the extendable portion 394. The axis 404 may define an angle 418 relative to the axis 398. As discussed above, the distal end 408 may also be moved a distance away from the distal end 412 of the extendable member 394.
- the capsule 402 may have a current 422 induced therein that may generate a field 426 that may be sensed by the tracking device 66. Similar to that discussed above, the sensing at the tracking device 66 of the field 426 may be used to determine a distance 430 and an arc length or position relative to the tracking device 66. Further, according to various embodiments, the push or moving member 434 may be flexible and allow the capsule 402 to be positioned at different angles relative to the axis 398. Therefore, the angle 418 may also be specifically determined. Thus, the navigation system may determine three degrees of freedom of a pose of the capsule 402 relative to the tracking device 66. Thus, the capsule 402 may be positioned relative to the distal end 412 and the three degrees of freedom including the distance 430, the angle 418, and an arc length or position, such as the arc 352, as discussed above.
- an angle 438 may be different than the angle 418 between the axis 404 and the axis 398 of the instrument 390.
- the distance and arc displacement may be the same, while the angle may be different.
- the capsule 402 may also be at a different angle when the moving or forcing member 434 is flexible.
- the instrument 390 may have three degrees of freedom of movement of the capsule 402 relative to the tracking device 66 that may be determined relative to the tracking device 66.
- three or more measured and determined metric components or metrics may be determined to determine three degrees of freedom (e.g., angles or dimensions).
- the instrument 390 may include features similar to the instrument 68 discussed above and the schematic illustrations of Figs. 10 and 11 may represent a physical or patient space position of the various portions of the instrument 390 and/or a graphical representation thereof.
- the pose or position of the capsule 402 may be determined relative to the tracking device.
- the tracking device may be tracked with the navigation system 20 for a representation and determination of the pose of the capsule 402.
- the pose of the capsule 402 may be determined due to the field 426, 426' that is generated based upon the induced current 422.
- the metric may be measured or determined at the tracking device 66 based upon the field 426, 426' that is generated by the capsule portion 402. This allows a determination of a pose of the capsule portion 402 relative to the tracking device 66 while the capsule portion 402 is not directly tracked by a tracking device connected directly thereto.
- a stapler may have various configurations or portions, as exemplary illustrated in Fig. 12.
- An instrument 460 is illustrated according to various embodiments in Fig. 12.
- the staplers 460 may include a first stapler 464 that includes a handle or grasping region 468 and a movable or stapling region 472.
- the moving region 472 may generally be movable and/or have a portion that is movable relative to the tracking device 66 that may be connected to a shaft 474 that extends from the handle.
- the stapler assembly 464 may include a first portion 478 that is substantially immovable relative to the shaft 474 and generally stays aligned with an axis 480 of the shaft.
- a distal tip point 484 which may also be referred to as a primary point, may generally be known at a fixed pose relative to the tracking device 66.
- a second portion or jaw 486 may move at a pivot point 488 relative to the first jaw portion 478. Therefore, an angle 490 may be formed between the first jaw 478 and the second jaw 486. The angle 490 may vary as the instrument 464 is manipulated during use.
- a measured or metric point 494 may be determined relative to the tracking device 66 and/or any other portion of the instrument 464 in a manner similar to that discussed above.
- the EM localizer 94 may generate a field that causes an induced current in at least the second jaw portion 486.
- an induced current 498 may generate a field 500 similar to that discussed above.
- the field 500 may be sensed by the tracking device 66. Therefore, a metric measured at the tracking device 66 may include the metrics as discussed above.
- the pose of the metric or measured point 494 may then be determined based upon the measurement of the metric at the tracking device 66. This may allow for a determination of the pose of at least the second jaw 486 relative to a portion of the instrument 464, such as the first jaw 478.
- the tracking of the metric or measured point 494 may allow for determination of a pose of both distal portions of the instrument 464. It may further assist in ensuring that appropriate tissues are captured for stapling or manipulating with the instrument 464. Further, it may be used to confirm that a selected distance or pose is achieved between various portions of the instrument 464, such as ensuring that the second jaw 486 moves close enough to the first jaw 478 for stapling selected tissues. Again, a pose of the various jaws of the instrument 464 may allow for confirming or performing a procedure.
- an instrument 520 may also include a handle portion 524 similar to the handle portion 468, a shaft portion 526 similar to the shaft portion 474 with a tracking device 66 connected thereto.
- the shaft may extend along an axis 528 that is substantially immovable relative to the handle 524.
- the instrument 520 may include two jaws or movable members including a first movable member 532 and a second movable member 534. The two movable members may move relative to a pivot portion 536 of the instrument 520.
- an instrument 460 may include an instrument 570.
- the instrument 570 may again include a handle 574 similar to the handle 524 discussed above, a shaft 576 similar to the shaft 526 discussed above and a tracking device 66 connected to the shaft 576.
- the shaft 576 may extend along an axis 578 relative to the tracking device 66, as discussed above.
- the instrument 570 may include two jaws or members including a first jaw 580 and a second jaw 584. Each of the jaws may move relative to each other and/or the shaft at a pivot point or joint 588.
- a field may be generated by a portion that does not have tracking device connected directly thereto. Therefore, a portion, such as a jaw or a capsule, may move relative to a tracking device while the tracking device remains stationary in a subject or a navigation space.
- the moving portion may have a current induced to therein which generates a field.
- the field generated by the induced current in the moving portion may effect a measurement of a metric at the tracking device 66, according to various embodiments as discussed above.
- the effect at the tracking device 66 may be a metric or may include a metric that is measured.
- the measurement of the metric may be used to determine a pose of the moving portion at an appropriate time, such as during movement or after it has stopped.
- the determined pose of the moving portion may be based upon a predetermined pose and measurement of the metric that may be predetermined and stored in a lookup table or other appropriate memory system. Therefore, when a metric is measured, the metric value may be compared to the lookup table to determine the pose of the moving portion.
- the moving portion need not have a tracking device connected directly thereto to allow for a determination of a pose of the moving portion.
- the lookup table may include a selected number of specific poses (e.g., locations and orientations) of the movable portion relative to the tracking device 66.
- Each of the poses may correlate to, as saved in the a lookup table, a measurement of the metric.
- a measured value of the metric is correlated to one pose of the moveable portion.
- a measured value of the metric may not match identically to only one predetermined measured value of the metric.
- the saved measurement value may include 1 , 2, and other values but the measured value may be 1.6. Therefore, the system, such as the processor module executing instructions, may interpolate between at least between two values to determine a likely pose of the movable portion during navigation. For example, the system may determine that the moveable portion is between the poses related to the measured values or 1 and 2, but 60% closer to the pose for the measured value of 2.
- a discrete lookup table of single or multiple metric parameters to single or multiple pose degrees of freedom may be saved.
- An interpolation between or amongst them using single or multivariate, linear or nonlinear, global or local, functions or splines or other interpolations may occur.
- a model (e.g., of the above interpolations) may be generated.
- the model may describe the relationship or relationships between or amongst single or multiple metric parameters to single or multiple pose degrees of freedom.
- the method 700 may be used to assist in performing a procedure to determine a pose of an instrument or at least a portion of an instrument that does not have a tracking device connected or affixed thereto.
- the tracking device may be affixed to at least a portion of an instrument and a second portion may move relative to the tracking device.
- the second portion may be a capsule, movable jaw, or any appropriate portion.
- the second or moveable portion may be navigated when no tracking device is connected directly thereto. Accordingly, discussion herein of a capsule is merely exemplary of a movable portion may have a current induced therein that generates a field.
- the method or process 700 may start in start block 704.
- the method 700 may then include loading an implant into an instrument as an optional step.
- the instrument may include an implant delivery system and therefore loading an implant block 708 may be optional step.
- the method 700 may then include positioning the capsule at a first position relative to the tracking device in block 710.
- the positioning of the capsule at a first position may include connecting or holding the capsule at a first position relative to the instrument, such as the instrument 200. This may include a time when the capsule is being moved or prior to the capsule being moved to a selected implant position.
- the moving of the instrument may include moving all of the instrument, including the capsule at the first position relative to the tracking device.
- the capsule may be moved relative to the tracking device, such as to a second position in block 714.
- Moving the capsule relative to the tracking device may include moving or pumping a fluid relative to the capsule as discussed above. This may allow the capsule to move relative to another portion of the instrument, such as a portion including the tracking device, as discussed above.
- the movement of the capsule may include moving the capsule from a proximate position near the tracking device to a remote position away from the tracking device.
- the capsule may include at least two poses relative to the tracking devices.
- the moveable portion may include a plurality of remote poses as discussed above.
- the process 700 may include portions that are generally inclusive of moving the instrument for various purposes, such as moving an instrument with an implant relative to a human subject.
- the process 700 may include at least a subroutine or portion 720 that includes the steps or elements as discussed above including optionally loading the implant in block 708, positioning the capsule at the first position relative to the tracking device in block 710, moving the instrument to a selected position in block 712, and moving a capsule to a second position relative to the tracking device in block 714.
- the navigation system including the tracking device 66, may be used to track the instrument substantially directly during the instrument having the capsule in the first position relative to the tracking device.
- Moving the capsule to the (or at least one) second position relative to the tracking device may allow the navigation system to measure a metric, as discussed above. Therefore, the navigation system may execute various instructions to determine a pose of the capsule once it is moved from the first position as discussed above, and according to at least the portions of a subroutine 730.
- a signal may be received from the tracking device based upon a sensing with the tracking device in block 734.
- a determination of a measurement of the metric may be made in block 736.
- the metric may be any appropriate metric, such as those discussed above.
- the determination of the metric may be based upon measuring the or receiving the sensed measurement and/or performing a calculation based upon this sensed measurement. For example, as discussed above, a field may be measured with the tracking device 66.
- the metric may be based upon the measurement of the field such as the field that is based upon or generated due to an induced current in the capsule.
- a recalled pose of the capsule may be made in block 740.
- the pose of the capsule may be predetermined based upon various measured or determined metrics. Therefore, the pose may be recalled once the metric is determined in block 736.
- the recall may include a use of a lookup table that compares the determined measurement of the metric with predetermined metric measurements and corelated poses.
- the pose may be output in block 744.
- the output pose may be recalled and/or determined.
- the pose may be based upon an interpolation between at least two predetermined measurements of the metric and related poses.
- the output may include various outputs, such as a visual indication of a pose of the capsule, such as a graphical representation on the display device 84.
- Other outputs may include an audio or visual confirmation of a predetermined pose, such as a proximity of the jaws of an instrument.
- a determination of whether the capsule has moved may be made in block 748.
- the determination of whether the capsule has moved in block 748 may be according to various processes. For example, the user may input that the capsule has moved such as with an appropriate input. Further, the system may sense that the capsule has moved such as with a change in the measured metric or signal received from the tracking device, such as with a continuous or constant measurement. Regardless, if a determination of the capsule has been moved is made a YES path 750 may be followed to receive a signal from the sensing of the tracking device in block 734. Therefore, the process 730 may iterate to allow for a continuous update of a pose of the capsule. The update may be substantially real time and may allow for a continuous iteration until the user has provided an input that the capsule has stopped moving or is not moving.
- the NO path 752 may include an optional confirmation of capsule pose relative to a plan in block 758.
- the capsule may be used to assist in positioning the implant 224. Therefore, the user may confirm that the capsule is at a selected pose, such as a pre-planned and/or determined pose, relative to the tracking device prior to ending a procedure.
- the navigation of the moveable portion e.g., the capsule
- the process 700 may end in END block 760 after determination that the capsule is no longer going to be moved by following path 752. However, if the capsule is not in a confirmed posed, the process may again iterate to receive additional signals in block 734, if selected.
- the system may be used to track a portion of an instrument that is not directly connected to a tracking device.
- the system may execute instructions similar or including instructions for forming at least a part of the method 700, such as the position determining sub-routine 730.
- the navigation system may include a processor that executes instructions to perform the steps as discussed above to allow for a determination, such as is substantially automatic determination, of the pose of a portion of the instrument, such as the capsule. Therefore, the system discussed above may allow for a substantially automatic determination by executing an instruction similar to those discussed above.
- the ultrasound probe may emit or transmit ultrasound waves in a selected pattern or plane.
- the plane may be a shape as is understood by one skilled in the art.
- the plane is generally able to acquire data in a field of view to generate images, also referred to as sonograms when images are generated based on ultrasound data.
- a system to navigate an instrument comprising: a first instrument portion; a tracking device connected to the first instrument portion; a second instrument portion having an interfering portion, wherein the second instrument portion is moveable relative to the tracking device; a navigation processor configured to execute instructions to: receive a field signal from the tracking device based at least in part on an interfering field generated by the interfering portion of the second instrument portion, determine a pose of the second instrument portion relative to the tracking device based on the received interfering field signal, and output the determined pose.
- the system of Claim 1 further comprising: a memory module having saved therein at least one of a look up table having saved therein at least a first pose of the second instrument portion related to a measurement of a metric measured at the tracking device based on the induced field or a model based thereon; wherein the navigation processor configured to execute instructions includes accessing the lookup table to recall the first pose to determine the pose of the second instrument portion relative to the tracking device.
- the memory module includes the lookup table having saved therein a plurality of poses of the second instrument portion related to a plurality of measurements of the metric measured at the tracking device based on the induced field; wherein the navigation processor configured to execute instructions includes accessing the lookup table to recall at least one pose to related to at least one measure of the plurality of measurements to determine the pose of the second instrument portion relative to the tracking device.
- the navigation processor configured to execute instructions includes accessing the lookup table to recall at least one pose to related to at least one measure of the plurality of measurements to determine the pose of the second instrument portion relative to the tracking device.
- the memory module includes the lookup table having saved therein a plurality of poses of the second instrument portion related to a plurality of measurements of the metric measured at the tracking device based on the induced field; wherein the navigation processor configured to execute instructions includes accessing the lookup table to recall at least two measurements of the plurality of measurements and interpolate between the recalled at least two measurements when only one of the measurements of the plurality of measurements does not match the measurement based on the received induced field signal.
- the system of Claim 1 further comprising: an imaging system configured to acquire an image or image data of the subject; wherein an image of the subject is operable to be reconstructed from the image data and displayed.
- a method to navigate an instrument having a first instrument portion and a second instrument portion within a field comprising: receiving an field signal from a tracking device connected to the first portion based at least in part on an interfering field generated by an interfering portion of the second instrument portion; determining a pose of the second instrument portion relative to the tracking device based on the received interfering field signal; and outputting the determined pose.
- a system to navigate an instrument comprising: a first instrument portion; a tracking device connected to the first instrument portion; a second instrument portion having an interfering portion, wherein the second instrument portion is moveable relative to the tracking device; a navigation processor configured to execute instructions to: receive a field signal from the tracking device based at least in part on an interfering field generated by the interfering portion of the second instrument portion, determine a pose of the second instrument portion relative to the tracking device based on the received interfering field signal, and output the determined pose.
- the system of Claim 1 further comprising: an electromagnetic (EM) field generator; wherein an EM generator field is generated by the EM field generator produces an interfering field from the interfering portion of the second instrument portion; wherein the navigation processor is configured to execute further instructions to receive a localizer signal from the tracking device based on the EM generator field generated by the EM field generator.
- EM electromagnetic
- the memory module includes the lookup table having saved therein a plurality of poses of the second instrument portion related to a plurality of measurements of the metric measured at the tracking device based on the induced field; wherein the navigation processor configured to execute instructions includes at least one of (1) accessing the lookup table to recall at least one pose to related to at least one measure of the plurality of measurements to determine the pose of the second instrument portion relative to the tracking device, or (2) accessing the lookup table to recall at least two measurements of the plurality of measurements and interpolate between the recalled at least two measurements when only one of the measurements of the plurality of measurements does not match the measurement based on the received induced field signal.
- a method to navigate an instrument within a field comprising: providing the instrument having a first instrument portion and a second portion; providing a tracking device connected to the first instrument portion; providing an interfering portion with second instrument portion; configuring the second instrument portion to be moveable relative to the tracking device; providing a navigation processor configured to execute instructions for: receiving a field signal from the tracking device based at least in part on an interfering field generated by an interfering portion of the second instrument portion, determining a pose of the second instrument portion relative to the tracking device based on the received interfering field signal, and outputting the determined pose.
- Example embodiments are provided so that this disclosure will be thorough and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure. In some example embodiments, well-known processes, well-known device structures, and well-known technologies are not described in detail.
- Instructions may be executed by a processor and may include software, firmware, and/or microcode, and may refer to programs, routines, functions, classes, data structures, and/or objects.
- the term shared processor circuit encompasses a single processor circuit that executes some or all code from multiple modules.
- the term group processor circuit encompasses a processor circuit that, in combination with additional processor circuits, executes some or all code from one or more modules. References to multiple processor circuits encompass multiple processor circuits on discrete dies, multiple processor circuits on a single die, multiple cores of a single processor circuit, multiple threads of a single processor circuit, or a combination of the above.
- the term shared memory circuit encompasses a single memory circuit that stores some or all code from multiple modules.
- the term group memory circuit encompasses a memory circuit that, in combination with additional memories, stores some or all code from one or more modules.
- a processor also referred to as a processor module
- a processor module may include a special purpose computer (i.e. , created by configuring a processor) and/or a general purpose computer to execute one or more particular functions embodied in computer programs.
- the computer programs include processor-executable instructions that are stored on at least one non-transitory, tangible computer-readable medium.
- the computer programs may also include or rely on stored data.
- the computer programs may include a basic input/output system (BIOS) that interacts with hardware of the special purpose computer, device drivers that interact with particular devices of the special purpose computer, one or more operating systems, user applications, background services and applications, etc.
- BIOS basic input/output system
- the computer programs may include: (i) assembly code; (ii) object code generated from source code by a compiler; (iii) source code for execution by an interpreter; (iv) source code for compilation and execution by a just-in-time compiler, (v) descriptive text for parsing, such as HTML (hypertext markup language) or XML (extensible markup language), etc.
- source code may be written in C, C++, C#, Objective-C, Haskell, Go, SQL, Lisp, Java®, ASP, Perl, Javascript®, HTML5, Ada, ASP (active server pages), Perl, Scala, Erlang, Ruby, Flash®, Visual Basic®, Lua, or Python®.
- Communications may include wireless communications described in the present disclosure can be conducted in full or partial compliance with IEEE standard 802.11-2012, IEEE standard 802.16-2009, and/or IEEE standard 802.20-2008.
- IEEE 802.11- 2012 may be supplemented by draft IEEE standard 802.11ac, draft IEEE standard 802.11ad, and/or draft IEEE standard 802.11 ah.
- a processor, processor module, module or ‘controller’ may be used interchangeably herein (unless specifically noted otherwise) and each may be replaced with the term ‘circuit.’ Any of these terms may refer to, be part of, or include: an Application Specific Integrated Circuit (ASIC); a digital, analog, or mixed analog/digital discrete circuit; a digital, analog, or mixed analog/digital integrated circuit; a combinational logic circuit; a field programmable gate array (FPGA); a processor circuit (shared, dedicated, or group) that executes code; a memory circuit (shared, dedicated, or group) that stores code executed by the processor circuit; other suitable hardware components that provide the described functionality; or a combination of some or all of the above, such as in a system-on-chip.
- ASIC Application Specific Integrated Circuit
- FPGA field programmable gate array
- processors or processor modules such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuitry.
- DSPs digital signal processors
- ASICs application specific integrated circuits
- FPGAs field programmable logic arrays
- processors or processor modules may refer to any of the foregoing structure or any other physical structure suitable for implementation of the described techniques.
- the techniques could be fully implemented in one or more circuits or logic elements.
- the processor or processors may operate entirely automatically and/or substantially automatically. In automatic operation the processor may execute instructions based on received input and execute instructions in light thereof. Thus, various outputs may be made without further or any manual (e.g., user) input.
- a system to navigate an instrument comprising: a first instrument portion; a tracking device connected to the first instrument portion; a second instrument portion having an interfering portion, wherein the second instrument portion is moveable relative to the tracking device; a navigation processor configured to execute instructions to: receive a field signal from the tracking device based at least in part on an interfering field generated by the interfering portion of the second instrument portion, determine a pose of the second instrument portion relative to the tracking device based on the received interfering field signal, and output the determined pose.
- Example 2 The system of Example 1 , further comprising: an electromagnetic (EM) field generator; wherein an EM generator field is generated by the EM field generator produces an interfering field from the interfering portion of the second instrument portion.
- EM electromagnetic
- Example s The system of Example 2, wherein the navigation processor is configured to execute further instructions to receive a localizer signal from the tracking device based on the EM generator field generated by the EM field generator.
- Example 4 The system of Example 1 , further comprising a display device configured to display a graphical representation based on the output determined pose.
- Example 5 The system of Example 4, wherein the display is configured to display an image of subject and the graphical representation is displayed relative to the image of the subject at a pose of the second instrument portion relative to the subject.
- Example 6 The system of Example 1 , wherein the second instrument portion is formed entirely of a interfering material.
- Example 7 The system of Example 1 , further comprising: an implant held relative to the second instrument portion.
- Example 8 The system of Example 1 , further comprising:
- a memory module having saved therein at least one of a look up table having saved therein at least a first pose of the second instrument portion related to a measurement of a metric measured at the tracking device based on the induced field or a model based thereon; wherein the navigation processor configured to execute instructions includes accessing the lookup table to recall the first pose to determine the pose of the second instrument portion relative to the tracking device.
- Example 9 The system of Example 8, wherein the memory module includes the lookup table having saved therein a plurality of poses of the second instrument portion related to a plurality of measurements of the metric measured at the tracking device based on the induced field; wherein the navigation processor configured to execute instructions includes accessing the lookup table to recall at least one pose to related to at least one measure of the plurality of measurements to determine the pose of the second instrument portion relative to the tracking device.
- Example 10 The system of Example 8, wherein the memory module includes the lookup table having saved therein a plurality of poses of the second instrument portion related to a plurality of measurements of the metric measured at the tracking device based on the induced field; wherein the navigation processor configured to execute instructions includes accessing the lookup table to recall at least two measurements of the plurality of measurements and interpolate between the recalled at least two measurements when only one of the measurements of the plurality of measurements does not match the measurement based on the received induced field signal.
- Example 11 The system of Example 1 , further comprising: an imaging system configured to acquire an image or image data of the subject; wherein an image of the subject is operable to be reconstructed from the image data and displayed.
- Example 12 A method to navigate an instrument within a field, comprising: providing the instrument having a first instrument portion and a second portion; providing a tracking device connected to the first instrument portion; providing an interfering portion with second instrument portion; configuring the second instrument portion to be moveable relative to the tracking device; providing a navigation processor configured to execute instructions for: receiving a field signal from the tracking device based at least in part on an interfering field generated by an interfering portion of the second instrument portion, determining a pose of the second instrument portion relative to the tracking device based on the received interfering field signal, and outputting the determined pose.
- Example 13 The method of Example 12, further comprising: providing an EM field generator to generate an EM generator field that produces the interfering field from the interfering portion of the second instrument portion.
- Example 14 The method of Example 13, further comprising: configuring the navigation processor to execute further instructions for receiving a localizer signal from the tracking device based on the EM generator field generated by the EM field generator.
- Example 15 The method of Example 12, further comprising: providing the second instrument portion formed entirely of a interfering material.
- Example 16 The method of Example 12, further comprising: providing a memory module having saved therein a look up table having saved therein at least a first pose of the second instrument portion related to a measurement of a metric measured at the tracking device based on the induced field;
- Example 17 The method of Example 16, further comprising: providing the memory module having saved therein the lookup table having saved therein a plurality of poses of the second instrument portion related to a plurality of measurements of the metric measured at the tracking device based on the induced field; configuring the navigation processor to execute further instructions for accessing the lookup table to recall at least one pose to related to at least one measure of the plurality of measurements to determine the pose of the second instrument portion relative to the tracking device.
- Example 18 The method of Example 16, further comprising: providing the memory module having saved therein the lookup table having saved therein a plurality of poses of the second instrument portion related to a plurality of measurements of the metric measured at the tracking device based on the induced field; configuring the navigation processor to execute further instructions for accessing the lookup table to recall at least two measurements of the plurality of measurements and interpolate between the recalled at least two measurements when only one of the measurements of the plurality of measurements does not match the measurement based on the received induced field signal.
- Example 19 The method of Example 12, further comprising: proving an imaging system configured to acquire an image or image data of the subject, wherein an image of the subject is operable to be reconstructed from the image data and displayed.
- Example 20 A method to navigate an instrument having a first instrument portion and a second instrument portion within a field, comprising: receiving an field signal from a tracking device connected to the first portion based at least in part on an interfering field generated by an interfering portion of the second instrument portion; determining a pose of the second instrument portion relative to the tracking device based on the received interfering field signal; and outputting the determined pose.
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Heart & Thoracic Surgery (AREA)
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Abstract
L'invention concerne un système d'aide au guidage et à la réalisation d'une intervention sur un sujet. Le sujet peut être n'importe quel sujet approprié tel qu'un objet inanimé et/ou un objet animé.
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| US202363593864P | 2023-10-27 | 2023-10-27 | |
| US202363593841P | 2023-10-27 | 2023-10-27 | |
| US63/593,841 | 2023-10-27 | ||
| US63/593,864 | 2023-10-27 |
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| Publication Number | Publication Date |
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| WO2025088575A1 true WO2025088575A1 (fr) | 2025-05-01 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/IB2024/060536 Pending WO2025088575A1 (fr) | 2023-10-27 | 2024-10-25 | Système et méthode de navigation |
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| WO (1) | WO2025088575A1 (fr) |
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