Patent Application
20230015694
The present disclosure relates to navigation, mapping, and tracking during endoscopic procedures. More particularly, the present disclosure relates to the use of an accelerometer for navigation, mapping, and tracking during endoscopic procedures.
During endoscopic procedures, there is a need to know the position of the scope tip. Currently, the position of the scope as well as other tools are tracked using fluoroscopy. However, when using fluoroscopy, there is a risk of prolonged exposure to radiation for the patient, physician, and operating room staff. Conventional electromagnetic sensors may be large and/or expensive. Conventional electromagnetic sensors may also require special conditions, such as, but not limited to, ferrite free environments and/or expensive capital. Further, even when using fluoroscopy and/or active computerized tomography (CT) are used, it may be impractical to receive real time data, such as roll, pitch, and positioning data of the endoscope and/or other tools. It may be desirable to provide systems and methods for navigation, mapping, and tracking of an endoscope which allow for the gathering of real-time data as well as a reduction in the exposure to radiation.
This disclosure provides design, material, manufacturing method, and use alternatives for medical devices.
In a first example, a method for determining and mapping a location of a distal end region of an elongate shaft may comprise obtaining data from an accelerometer, the accelerometer located in the elongate shaft adjacent a distal end thereof, determining a length of the elongate shaft inserted into a body from a reference point, merging the accelerometer data and the length of the elongate shaft to localize the distal end region of the elongate shaft, reconstructing a line of travel of the medical device within the body, and superimposing the reconstructed line of travel over an image of an anatomy of the patient.
Alternatively or additionally to any of the examples above, in another example, the method may further comprise obtaining an image from a camera positioned at the distal end of the elongate shaft.
Alternatively or additionally to any of the examples above, in another example, the method may further comprise detecting feature points from the image.
Alternatively or additionally to any of the examples above, in another example, the method may further comprise merging the feature points and the localized distal end region of the elongate shaft.
Alternatively or additionally to any of the examples above, in another example, the image of the anatomy may be a 3-dimensional (3D) reconstruction of the anatomy adjacent to the distal end region.
Alternatively or additionally to any of the examples above, in another example, the image of the anatomy may be a 3-dimensional CT scan.
Alternatively or additionally to any of the examples above, in another example, obtaining the data from an accelerometer and determining the length of the elongate shaft inserted into the body may be performed with the distal end of the elongate shaft at a same location.
Alternatively or additionally to any of the examples above, in another example, obtaining data from an accelerometer may comprise obtaining accelerometer data from a plurality of different locations of the distal end of the elongate shaft.
Alternatively or additionally to any of the examples above, in another example, determining the length of the elongate shaft inserted into the body may comprise obtaining a length from a plurality of different locations of the distal end of the elongate shaft.
Alternatively or additionally to any of the examples above, in another example, obtaining an image may comprise obtaining an image from a plurality of different locations of the distal end of the elongate shaft.
In another example, a system for determining a position of a medical device in a body may comprise an elongate shaft extending from a proximal end to a distal end, an accelerometer located in the elongate shaft adjacent to the distal end thereof, a plurality of demarcations formed on an outer surface of the elongate shaft, the demarcations longitudinally spaced at predefined intervals along a length of the elongate shaft, a first optic sensor and a second optic sensor, the first and second optic sensors configured to be positioned adjacent to the body and longitudinally spaced apart, and a computing device operably coupled to the accelerometer, the first optic sensor and the second optic sensor.
Alternatively or additionally to any of the examples above, in another example, the first and second optic sensors may be configured to detect and count the plurality of demarcations as the elongate shaft is advanced into the body.
Alternatively or additionally to any of the examples above, in another example, the first and second optic sensors may be configured to detect a direction of travel of the elongate shaft.
Alternatively or additionally to any of the examples above, in another example, the computing device may be configured to determine a length of the elongate shaft that has been advanced into the body from a reference point based on the detection and counting of the plurality of demarcations.
Alternatively or additionally to any of the examples above, in another example, the system may further comprise a gyro sensor.
In another example, a method for tracking a location of a medical device may comprise advancing a medical device within a body of a patient, receiving data from an accelerometer, the accelerometer positioned adjacent a distal end of an elongate shaft of the medical device, determining an insertion length of the elongate shaft, reconstructing a line of travel of the medical device within the body, superimposing the reconstructed line of travel over an image of an anatomy of the patient, and displaying the image of the anatomy with the superimposed line of travel on a user interface.
Alternatively or additionally to any of the examples above, in another example, the image of the anatomy may be a 3-dimensional CT scan.
Alternatively or additionally to any of the examples above, in another example, the method may further comprise positioning virtual markers on the image of the anatomy with the superimposed line of travel.
Alternatively or additionally to any of the examples above, in another example, the virtual markers may be placed through actuation of a button on a handle of the medical device.
Alternatively or additionally to any of the examples above, in another example, the method may further comprise receiving data from a gyro sensor,
The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
The disclosure may be more completely understood in consideration of the following detailed description in connection with the accompanying drawings, in which:
While the disclosure is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the disclosure to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
It is noted that references in the specification to “an embodiment”, “some embodiments”, “other embodiments”, etc., indicate that the embodiment described may include one or more particular features, structures, and/or characteristics. However, such recitations do not necessarily mean that all embodiments include the particular features, structures, and/or characteristics. Additionally, when particular features, structures, and/or characteristics are described in connection with one embodiment, it should be understood that such features, structures, and/or characteristics may also be used connection with other embodiments whether or not explicitly described unless clearly stated to the contrary.
The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the disclosure.
Systems and methods for the navigation, mapping, and tracking of an endoscope and/or various tools used therewith are described herein. During a medical procedure (e.g., an endoscopic procedure, ureteroscopic procedure, etc.), it is desirable for the physician to know the location of the distal tip of the endoscope, ureteroscope, or other device or tool to help the physician navigate complex anatomy. To help the physician navigate in the anatomy, an accelerometer chip may be embedded in the distal tip of an elongate shaft of a device. The accelerometer may provide the direction of movement and/or acceleration of the chip in the X, Y, and Z directions, and thus the direction movement and/or acceleration of the distal tip in the X, Y, and Z directions. Together with determining a length of insertion and/or retraction of the shaft of the device, the movement of the device in 3-dimensional (3-D) space can be computed. While the present systems and methods are described with respect to an endoscope, it should be understood the present disclosure is not limited to such a device. For example, the systems and methods described herein may be used with other medical devices in which navigation, mapping, and/or tracking are utilized including, but not limited to ureteroscopes, colonoscopes, nephroscopes, catheters, intravascular devices, etc.
In some embodiments, the endoscopic system 20 may be in electronic communication with a workstation via a wired connection or data transmission cable 50. In some embodiments, the workstation may include a touch panel computer, an interface box for receiving the wired connection 50, a cart, and a power supply, among other features. In some embodiments, the electronic device to which the wired connection 50 is connected may have functionality for recognizing and exchanging data with other endoscopic accessories. Other configurations are also contemplated. In some embodiments, the interface box may be configured with a wired or wireless communication connection with a controller of the fluid management system. The touch panel computer may include at least a display screen and an image processor. In some embodiments, the workstation may be a multi-use component (e.g., used for more than one procedure) while the endoscopic system 20 may be a single use device, although this is not required. In some embodiments, the workstation may be omitted and the endoscopic system 20 may be electronically coupled directly to the controller of the fluid management system. Additionally, or alternatively, a microprocessor may be embedded in the handle 22 of the endoscopic system 20. In some cases, the wired connection may be configured to transmit data and/or image signals from one or more components of the endoscopic system 20. It is contemplated that the elongate shaft 30 may include one or more working lumens within which the data transmission cable 50 (e.g., fiber optic cable, optic cable, connector, wire, etc.) may extend.
As shown in
In some embodiments, the location of the distal end region 32 of the elongate shaft 30 may be tracked during use. For example, as will be described in more detail herein, the accelerometer 36 may provide the direction of the movement and/or acceleration of the chip which may be used to determine a location of the distal end region 32. In some cases, the accelerometer 36 may be used in combination with a CT scan, or other imaging capability. The workstation and/or control unit may communicate to determine the position of the accelerometer 36 relative to the patient.
The endoscopic system 20 includes the handle 22 coupled to a proximal end of the elongate shaft 30. The handle 22 may have an optional fluid flow on/off switch 23, which allows the user to control when fluid is flowing through the endoscopic system 20 and into the treatment site. The handle 22 may further include other buttons 24, 26 that perform other various functions. For example, in some embodiments, the handle 22 may include buttons to control the temperature of the fluid, fluid flow rate, activation of another medical device, etc. It will be understood that while the exemplary embodiment describes a ureteroscope, the features detailed above may also be directly integrated into another endoscope (e.g., a cystoscope, a nephroscope, a hysteroscope), or virtually any device with an image capability. In some embodiments, the endoscopic system 20 may also include a drainage port 28 which may be connected to a drainage system (not shown). Some illustrative drainage systems are described in commonly assigned U.S. Patent Application Publication No. 2018/0361055, titled AUTOMATED FLUID MANAGEMENT SYSTEM, the disclosure of which is hereby incorporated by reference.
Briefly, the fluid management system may include an inflow pump configured to pump and/or transfer fluid from a fluid supply source (e.g., a fluid bag, etc.) to the medical device 20 and/or a treatment site within a patient at a fluid flow rate. In some cases, the fluid may pass through a fluid warming system for heating fluid to be delivered to the patient via the one or more supply line(s) prior to entering the endoscopic system 20. In some embodiments, the fluid management system may be one that may be used in an endoscopic procedure, such as flexible ureteroscopy (fURS) procedures (e.g., ureteroscopy, percutaneous nephrolithotomy (PCNL), benign prostatic hyperplasia (BPH), transurethral resection of the prostate (TURP), etc.), gynecology, and other endoscopic procedures. Some illustrative fluid management systems and fluid warming systems are described in described in commonly assigned U.S. Patent Application Publication No. 2018/0361055, titled AUTOMATED FLUID MANAGEMENT SYSTEM, the entire disclosure of which is hereby incorporated by reference.
The distal end region 32 of the elongate shaft 30 may further include an accelerometer 36. The accelerometer 36 may be a multi-axis accelerometer, such as, but not limited to a 3-axis accelerometer or a 6-axis accelerometer. For example, the accelerometer 36 may measure acceleration in the X, Y, and Z planes. Additionally or alternatively, the accelerometer 36 may measure acceleration in the yaw, pitch, and roll axes. The accelerometer 36 may be positioned a predetermined or known distance from the distal end 42 of the elongate shaft 30 in order to determine a location of the distal tip. The accelerometer 36 may have a size that allows it to be disposed within or embedded within the elongate shaft 30. It is contemplated that the accelerometer 36 need not be positioned in a particular orientation. For example, the accelerometer 36 is not necessarily positioned such that it is oriented towards the distal end 42.
The accelerometer 36 may be communicatively coupled to a workstation, or other processing device, via one or more data transmission cables 56. The data transmissions cables 56 may extend proximally from the accelerometer 36 through the elongate shaft 30 to the handle 22. In the illustrated embodiment, the accelerometer 36 may include eight connector points and therefore eight cables 56 may extend from the accelerometer 36 through the elongate shaft 30 to the handle 22. However, fewer than eight or more than eight connector points and/or cables 56 may be provided, as desired.
It is contemplated that the direction of movement and/or acceleration of the accelerometer 36 in the X, Y, Z direction as provided by the accelerometer 36 can be combined with a length of insertion and/or retraction of the elongate shaft 30 to compute the movement of the endoscopic system 20.
The demarcations 60 may be used in conjunction with one or more sensors to determine the insertion length of the elongate shaft 30, and thus the distance the distal end region 32 of the elongate shaft has traveled from some reference point (e.g., the entry point into the patient). The demarcations 60, in conjunction with the one or more sensors may also determine the direction of movement of the elongate shaft, either distal advancement into the body of the patient or proximal retraction out of the body of the patient. For example, the distal end 64 of the demarcation 60 may create a first output and the proximal end 66 of the demarcation 60 may create a second output. At least one sensor, or two or more sensors 70, 72 (schematically illustrated in
The computing device 100 may include a bus 104 that, directly and/or indirectly, couples the following devices: a processing unit 102, a memory 106, an input/output (I/O) port 108, a user interface 110, and a power supply 112. Any number of additional components, different components, and/or combinations of components may also be included in or connected to the computing device. The memory 106 may be in communication with the processor 102. The memory 106 may be used to store any desired information such as, but not limited to, control algorithms, configuration protocols, set points, and the like. In some embodiments, the memory 106 may include specific programs or modules configured to determine a position and/or orientation of the distal end region 32 of the elongate shaft 30 and/or generate an image of the endoscopic system 20. The memory 106 may be any suitable type of storage device including, but not limited to, RAM, ROM, EPROM, flash memory, a hard drive, and/or the like. In some cases, the processor 102 may store information within the memory 106 and may subsequently retrieve the stored information from the memory 106. In embodiments, the memory 106 stores computer-executable instructions for causing the processor 102 to implement aspects of embodiments of system components discussed herein and/or to perform aspects of embodiments of methods and procedures discussed herein.
The computer-executable instructions may include, for example, computer code, machine-useable instructions, and the like such as, for example, program components capable of being executed by one or more processors associated with the computing device. Program components may be programmed using any number of different programming environments, including various languages, development kits, frameworks, and/or the like. Some or all of the functionality contemplated herein may also, or alternatively, be implemented in hardware and/or firmware.
The input/output port (I/O port) 108 may have a number of wire terminals for receiving one or more signals from the camera 33, sensors 34, 35, 36, 37, 70, 72 and/or system components and/or for providing one or more signals to the system components. In some cases, the I/O port 108 may communicate with one or more components of the endoscopic system 20, including, but not limited to, the camera 33 and/or sensors 34, 35, 36, 37, 70, 72. The computing device 100 may have any number of wire terminals for accepting a connection from one or more components of the system 10. However, how many wire terminals are utilized and which terminals are wired is dependent upon the particular configuration of the endoscopic system 20. Different systems 20 having different components and/or types of components may have different wiring configurations. In some cases, the I/O port 108 may be configured to receive wireless signals from the camera 33, sensors 34, 35, 36, 37, 70, 72 and/or one or more components or sensors (not explicitly shown). Alternatively, or additionally, the I/O port 108 may communicate with another controller.
The user interface 110 may include a display and a means for receiving user input (e.g., a microphone, a joystick, a satellite dish, a scanner, a printer, a wired and/or wireless device, a keyboard, a pen, a voice input device, a touch input device, a touch-screen device, an interactive display device, a mouse, and/or the like). In some cases, the user interface 110 may be integral to, or a part of, the computing device 100. Alternatively, or additionally, the computing device 100 may be operatively coupled to a remotely located user interface 110 including a display and a means for receiving user input. For example, the remotely located user interface 110 may be a separate display, a portable device, such as, but not limited to a smartphone, tablet computer, laptop computer, etc., or other such device. Additionally, or alternatively, the user interface 110 may further include other components configured to present information to a user such as, for example, a display device, a speaker, a printing device, and/or the like. In some cases, a user interface 110 may be omitted.
The bus 104 represents what may be one or more busses (such as, for example, an address bus, data bus, or combination thereof). Similarly, in embodiments, the computing device 100 may include a number of processing units 102, a number of memory components 106, a number of I/O ports 108, a number of user interface components 110, and/or a number of power supplies 112. Additionally, any number of these components, or combinations thereof, may be distributed and/or duplicated across a number of computing devices.
The computing device may receive data from the camera 33, accelerometer 36, and optic sensors 70, 72 to determine and map a location of the distal end region 32 of the elongate shaft 30.
The accelerometer 36 may transmit the accelerometer reading 202 as raw count data for the X, Y, and Z axis. The raw count may depend on the measurable range of force (e.g., g-force) and the resolution. For example, the accelerometer 36 may have a range of about 8 g with a 14 A/D converter (ADC) resolution. However, a range of less than 8 g or more than 8 g may be used, as desired. Further, the resolution may be less than 14 ADC or greater than 14 ADC, as desired. The raw count data may be converted to acceleration values in appropriate units, such as meters per second squared (m/s2). The optical sensors 70, 72 may be configured to maintain a count of the demarcations 60 which can be converted into the insertion length 204 of the elongate shaft 30. For example, the optical sensors 70, 72 may be configured to count both distal advancement and proximal retraction of the elongate shaft 30 so that the length of the shaft 30 that is within the patient can be determined at any point in time. The accelerometer reading 202 and the elongate shaft 30 insertion length 204 at any temporal occasion may be combined or merged 203 to localize the distal end region 32 of the elongate shaft, as shown at block 208. This may provide an estimate or approximation of the tip location. It is contemplated that an accelerometer reading 202 and an insertion length 204 may be determined for a plurality of tip locations 302, 304, 306, 308. Fewer than four or more than four tip locations may be used, as desired. For example, steps 202, 204, 203, 208 may be repeated for a plurality of different tip locations.
In some cases, the camera 33 may be configured to transmit live video or still images as the endoscopic system 20 is advanced through the body. It is contemplated that an individual image frame 206 may be analyzed for feature point detection 210. For example, the camera 33 may constantly (i.e., continuously) or intermittently capture image frames 206 from which feature points may be extracted. Feature points P1, P2, P3, P4 (see, for example,
The computing device 100 may then combine 209 the tip localization data 208 and the feature point data 210 to perform visual inertial odometry 212 to determine an accurate tip location. For example, the position and orientation of the distal end 42 of the elongate shaft 30 may be determined by analyzing the image and the movement of the distal end region 32 (as determined by the insertion length 204 and accelerometer reading). After the tip location is calculated, structure from motion imaging technique 214 may then be applied to calculate the 3D coordinates of the feature's points. For example, the local motion signals (e.g., from the accelerometer), 3D coordinates of the feature points, and/or the two-dimensional images from the camera 33 may be combined to generate a 3D structure or image of the anatomical structure.
The computing device 100 then utilizes the structure from motion analysis 214 to generate a 3D reconstruction 216 of the anatomical structure with the distal end region 32 of the elongate shaft 30. This computing device 100 may then display the rendering on the user interface 110 or other display, as shown at block 218.
The computing device 100 may be programmed to utilize the accelerometer data 402, the data from a shape sensing or gyro sensor 404 and the shaft insertion and/or retraction length 406 to reconstruct or generate a line of travel of the elongate shaft 30 in 3D space 408. The computing device 100 may then superimpose the line of travel over a 3D CT scan of the anatomy, or other imaging technique, to be displayed on the user interface 110.
The computing device 100 may be further configured to identify anatomical landmarks 508 utilizing video data or still images obtained from the camera 33. For example, the computing device 100 may be configured to utilize finger printing techniques and/or optical navigation to obtain a picture of the anatomy. The computing device 100 may be programmed to utilize the accelerometer data 402, the data from a shape sensing or gyro sensor 404 and the shaft insertion and/or retraction length 406, and the anatomical landmarks 410 to reconstruct or generate a 3D reconstruction of the anatomy. It is contemplated that virtual markings may be positioned on the reconstruction to facilitate navigation to a previous position of the elongate shaft. In other cases, virtual markings may be used to help locate kidney stones. Virtual markings or pins may be dropped or placed on the display through actuation of a button on the handle 22 of the endoscopic system 20 or through the user interface 110, as desired.
It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the disclosure. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The disclosure's scope is, of course, defined in the language in which the appended claims are expressed.
This application claims the benefit of and priority to U.S. Provisional Patent Application Ser. No. 63/221,995 filed on Jul. 15, 2021, the disclosure of which is incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63221995 | Jul 2021 | US |
