System for guiding an interventional instrument to an internal target

Abstract

A system for guiding an interventional instrument (150) to an internal target in a subject is provided. The system includes a guiding device (100) configured to be placed on an external surface of the subject and a shape sensing device (140). The guiding device includes a holder (120) configured to receive the interventional instrument (150) and provide an entry trajectory of the interventional instrument (150) to guide the interventional instrument (150) to the target, and a fastener (130) attached to a portion of the guiding device (100). The shape sensing device (140) provides shape sensing data indicative of a shape of at least a portion of the shape sensing device (140) fixed to the guiding device (100) by the fastener (130). The shape sensing data enables determination of a position and an orientation of the guiding device (100) on the external surface of the subject.

Description

Background Technology

[0001] Minimally invasive surgery relies on the ability to accurately access targets (such as blood vessels, internal organs, or tumors) within the patient's body using interventional instruments with minimal damage to surrounding areas. Achieving the correct location for percutaneous access to the internal target requires identifying the access point on the patient's surface (e.g., x, y, z coordinates in a three-dimensional coordinate system) and two angular adjustments that define the trajectory of the interventional instrument from the access point to the internal target. Typically, providing navigation guidance improves target localization and reduces procedure time. Furthermore, in cases where x-ray imaging is used during minimally invasive surgery, effective navigation guidance reduces the x-ray dose the patient would otherwise receive.

[0002] One option for providing guidance during percutaneous access is to integrate the sensor directly into the interventional device itself. However, this has the disadvantages of requiring modifications to the interventional device, which can be hampered by geometric limitations (e.g., especially for needles), the wide range of available interventional device types, and various price points. Summary of the Invention

[0003] According to one aspect of this disclosure, a system for guiding an interventional device to an internal target within a subject is provided. The system includes a guiding device configured to be placed on an outer surface (e.g., skin) of the subject, the guiding device comprising: at least one retainer configured to receive the interventional device and guide it to the target according to an entry trajectory; and a fastener attached to or capable of being attached to a portion of the guiding device having a fixed shape having at least one identifiable shape feature. The system also includes a shape sensing device secured to the guiding device by the fastener, such that at least a portion of the shape sensing device secured to the guiding device has a fixed shape having at least one identifiable shape feature, the shape sensing device being arranged to provide shape sensing data relating to the fixed shape of the at least portion of the shape sensing device secured to the guiding device by the fastener.

[0004] The system may also include a processing unit and a memory for storing instructions, which, when executed by the processing unit, cause the processing unit to: receive initial image data from an initial image of the target within the subject's body; define the location of the target in the initial image data; receive shape sensing data from a shape sensing device indicating the shape of at least a portion of the shape sensing device attached (e.g., inserted through a sleeve) to a guide device; use the shape sensing data to determine the location and orientation of the guide device; use the shape sensing data to determine the location of an interventional instrument relative to a portion of the shape sensing device attached to the guide device, the location including the entry point and entry trajectory of the interventional instrument; and display on a display an indication of the determined location of the interventional instrument overlapping with the initial image of the region of interest, thereby enabling a user or robot to manipulate the interventional instrument toward the target using the initial image data and / or feedback from sensors on the guide device. Attached Figure Description

[0005] The exemplary embodiments can be best understood by reading in conjunction with the accompanying drawings and the following detailed description. It should be emphasized that the features are not necessarily drawn to scale. In fact, dimensions may be increased or decreased arbitrarily for clarity of explanation. Where applicable and practical, the same reference numerals refer to the same elements.

[0006] Figure 1A This is a plan view of a guide device with an optical shape sensing (OSS) device according to a representative embodiment, the guide device being configured to guide an interventional instrument to an internal target within a subject's body.

[0007] Figure 1B This is a plan view of a guide device having a shape sensing device attached to an interventional device, according to a representative embodiment, for guiding the interventional device to an internal target within a subject's body.

[0008] Figure 2A This is a plan view of a retainer according to a representative embodiment, the retainer including discrete guide channels corresponding to different entry trajectories for guiding interventional instruments.

[0009] Figure 2B This is a plan view of a retainer according to a representative embodiment, the retainer including a single, pivoting guide channel that provides a series of entry trajectories for guiding interventional instruments.

[0010] Figure 3 This is a simplified block diagram of a guidance system according to a representative embodiment, the guidance system including a guidance device for guiding an interventional instrument to an internal target within a subject's body.

[0011] Figure 4It is an initial X-ray image of an internal target according to a representative embodiment, wherein the guiding device is in the field of view.

[0012] Figure 5A This is a top plan view of a guiding device integrated with an ultrasound probe, according to a representative embodiment, for guiding interventional instruments to internal targets within a subject's body.

[0013] Figure 5B This is a bottom plan view of a guiding device integrated with an ultrasound probe, according to a representative embodiment, for guiding interventional instruments to internal targets within a subject's body.

[0014] Figure 6 This is a plan view of a guide device with a visual indicator for guiding an interventional device to an internal target within a subject, according to a representative embodiment.

[0015] Figure 7A This is a plan view of a deformable guide device in a neutral orientation according to a representative embodiment.

[0016] Figure 7B This is a plan view of a deformable guide device in a neutral orientation according to a representative embodiment.

[0017] Figure 7C This is a plan view of a deformable guide device in a neutral orientation according to a representative embodiment.

[0018] Figure 8A This is a plan view of a deformable guide device in a neutral orientation according to a representative embodiment.

[0019] Figure 8B This is a plan view of a deformable guide device in a neutral orientation according to a representative embodiment.

[0020] Figure 8C This is a plan view of a deformable guide device in a neutral orientation according to a representative embodiment.

[0021] Figure 9 It is a flowchart illustrating a method, according to a representative embodiment, for guiding an interventional instrument to an internal target within a subject using a guiding device and a shape sensing device. Detailed Implementation

[0022] In the following detailed description, representative embodiments with specific details disclosed are set forth for purposes of explanation and not limitation, in order to provide a thorough understanding of embodiments according to this teaching. Descriptions of known systems, apparatuses, materials, methods of operation, and methods of manufacture may be omitted to avoid obscuring the description of representative embodiments. However, systems, apparatuses, materials, and methods within the scope of this teaching are applicable to those skilled in the art and can be used according to representative embodiments. It should be understood that the terminology used herein is for describing particular embodiments only and is not intended to be limiting. The defined terminology complements the technical and scientific meanings of the defined terms commonly understood and accepted in the art of this teaching.

[0023] It should be understood that although the terms first, second, third, etc., may be used herein to describe various elements or components, these elements or components should not be limited by these terms. These terms are used only to distinguish one element or component from another. Therefore, without departing from the teachings of the inventive concept, the first element or component discussed below may be referred to as the second element or component.

[0024] The terminology used herein is used only to describe particular embodiments and is not intended to be limiting. As used in the specification and appended claims, the singular forms of the terms “a,” “an,” and “the” are intended to include both the singular and plural forms unless the context clearly indicates otherwise. Furthermore, the terms “comprising,” “including,” and / or similar terms specify the presence of the stated features, elements, and / or components, but do not exclude the presence or addition of one or more other features, elements, components, and / or groups thereof. As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items.

[0025] Unless otherwise stated, when an element or component is referred to as being “connected,” “joined,” or “adjacent” to another element or component, it should be understood that the element or component may be directly connected or joined to the other element or component, or that there may be an intermediate element or component between them. That is, these and similar terms cover situations where two elements or components can be connected using one or more intermediate elements or components. However, when an element or component is referred to as being “directly connected” to another element or component, this only covers situations where the two elements or components are connected to each other without any intermediate or intervening element or component.

[0026] Therefore, this disclosure is intended to provide one or more advantages, specifically indicated below, through its aspects, embodiments, and / or particular features or sub-components. Exemplary embodiments with specific details disclosed are presented for purposes of explanation and not limitation, in order to provide a thorough understanding of embodiments according to these teachings. However, other embodiments consistent with this disclosure and departing from the specific details disclosed herein remain within the scope of the appended claims. Furthermore, descriptions of well-known devices and methods may be omitted so as not to obscure the description of exemplary embodiments. Such methods and devices are within the scope of this disclosure.

[0027] Figure 1A This is a plan view of a guide device with a shape sensing device according to a representative embodiment, the guide device being configured to guide an interventional instrument to an internal target within a subject's body.

[0028] refer to Figure 1A The guiding device 100 is configured to be placed on the outer surface (e.g., skin) of the subject and includes a support structure 110 configured to receive an interventional device (e.g., Figure 1B The guide device 100 (illustrated as 150) and retainer 120 guide the device toward the target according to the entry trajectory, along with fasteners 130 attached to a portion of the support structure 110. The guide device 100 must be correctly positioned on the subject for percutaneous entry such that the device intersects the target as it advances through the retainer 120. This requires identifying the position (x, y, z position) in a three-dimensional (3D) coordinate system on the subject's surface, and two angular adjustments to define the entry trajectory. This navigation guidance improves the device's entry into the target, thereby reducing procedure time and eliminating or reducing the need for real-time imaging. When imaging is provided by an X-ray system, this reduces the X-ray dose required during navigation.

[0029] In the illustrated embodiment, the support structure 110 has an outer frame 115 forming the outer periphery of the guide device 100, and cross supports that attach the retainer 120 to the outer frame 115 across an opening region within the outer periphery of the guide device 100. The cross supports include a first cross support 111 and a second cross support 112 arranged across the opening region in a first direction, and a third cross support 113 arranged in a second direction substantially perpendicular to the first direction. Thus, the first cross support 111, the second cross support 112, and the third cross support 113 secure the retainer 120 to the outer frame 115.

[0030] The guiding device 100 can be rigid or flexible. That is, in one embodiment, the support structure 110 can be formed of a flexible material (e.g., silicone rubber). This allows the support structure 110 to deform against the outer layer of the subject, which can help guide the interventional device toward the target by increasing the degrees of freedom of the entry trajectory options provided by the retainer 120. Alternatively, the support structure 110 can be formed of a substantially rigid material, such as acrylonitrile-butadiene-styrene (ABS) or other thermoplastic polymers, which, for example, can increase durability.

[0031] In the illustrated embodiment, the outer frame 115 of the support structure 110 is substantially circular, and for illustrative purposes, the retainer 120 is secured by three representative cross supports: a first cross support 111, a second cross support 112, and a third cross support 113. However, it should be understood that the outer frame 115 can have any of a variety of different shapes, such as square, rectangular, triangular, elliptical, and trapezoidal, without departing from the scope of the invention. It should also be understood that the support structure 110 can have more or fewer than three cross supports arranged at any angle relative to each other to secure the retainer 120, without departing from the scope of the invention. Alternatively, without departing from the scope of the invention, the retainer 120 can be secured by a material that substantially fills the opening area defined by the outer frame 115.

[0032] Fastener 130 is configured to receive shape sensing device 140, such as an elongated optical shape sensing (OSS) device, thereby securing it to a portion of support structure 110 in a manner that maintains a recognizable fixed shape relative to support structure 110, wherein the fixed shape has at least one recognizable shape feature. For example, fastener 130 may take the shape of a portion of support structure 110 to which it is attached, such that at least one recognizable shape feature is the shape of shape sensing device 140, such as a bend. Of course, other recognizable shape features may be included, such as one or more protrusions and / or one or more recesses, without departing from the scope of this teaching. In the illustrated embodiment, fastener 130 is implemented as a sleeve through which it inserts into shape sensing device 140. The sleeve may be formed of, for example, a polytetrafluoroethylene (PTFE) plastic tube, but may contain any compatible material. Moreover, in the illustrated embodiment, fastener 130 presents the shape of a portion of the periphery of support structure 110 to which it is attached, in this case, the shape of the upper part of outer frame 115. In alternative embodiments, the fastener 130 may be any means or structure capable of securing the shape sensing device 140 to the support structure 110 of the guide device 100, such that the shape sensing device has an identifiable fixed shape and / or other identifiable shape features. For example, the fastener 130 may include a “U”-shaped channel formed along a portion of the outer frame 115, wherein the shape sensing device 140 is press-fitted into the “U”-shaped channel. Alternatively, the fastener 130 may include one or more clips that are attached to or capable of being attached to the guide device 100 and attach the shape sensing device 140 to a portion of the outer frame 115.

[0033] In the illustrated embodiment, the outer frame 115 has a distinctive shape or curvature profile, including one or more distinctive shape features that are converted into a path defined by the fastener 130 as identifiable shape features upon attachment to the outer frame 115. The distinctive shape allows detection of the guide device 100 and alignment of the guide device 100 with the shape sensing device 140. In the illustrated embodiment, the outer frame 115 includes three representative shape features that are nodular portions projecting from an additional circular outer periphery of the support structure 110. That is, the outer frame 115 and the fastener 130 include a first protrusion 131 located at the 12 o'clock position (frame top), a second protrusion 132 located at the 9 o'clock position (OSS device entry position), and a third protrusion 133 located at the 3 o'clock position (OSS device exit position) of the outer frame 115.

[0034] The shape sensing device 140 may be an OSS device, for example, comprising one or more optical fibers having an integrated fiber Bragg grating (FBG) used as a strain sensor to detect shape information and provide shape sensing data indicative of the shape of the shape sensing device 140, as is known to those skilled in the art. The shape sensing device 140 may be implemented by any shape sensing device that can be inserted into or otherwise secured by a fastener 130, such as a guidewire, conduit, or sheath. For example, the shape sensing device 140 may be implemented using fiber optic true shape (FORS) technology, in which case the shape sensing data includes FORS data, including but not limited to the 3D shape, curvature, and axial strain of the shape sensing device 140. In alternative embodiments, the shape sensing device 140 may be implemented using shape sensing techniques other than optical shape sensing. For example, the shape sensing device 140 may include transducers, electrodes, and / or electromagnetic sensors arranged along at least a portion of the shape sensing device, such that the shape of the device can be determined. For example, if three or more electromagnetic sensors are attached to the shape sensing device 140, shape and / or other identifiable shape features can be determined from these three locations, thereby providing position and orientation for the guide device 100. Generally, the more sensors arranged on the shape sensing device 140, the better the shape resolution and accuracy will be provided. Typically, the guide device 100 includes specific features located in the insertion path of the interventional instrument that can be detected in the shape profile (e.g., curvature, strain, temperature) provided by the shape sensing device 140.

[0035] Since the shape sensing device 140 is inserted into or otherwise attached to the fastener 130, the shape sensing data provided by the shape sensing device 140 indicates the shape of the fastener 130, and thus indicates the shape and / or other identifiable shape features of the upper portion of the outer frame 115 to which the fastener 130 is attached. Therefore, the position of the upper portion of the outer frame 115 can be located in a 3D coordinate system based on this distinctive shape sensing data. Furthermore, the first protrusion 131, the second protrusion 132, and the third protrusion 133 enable the shape sensing device 140 to accurately indicate the specific portion of the upper portion of the outer frame 115. Once the position of the upper portion of the outer frame 115 is determined, the position of the retainer 120, which is also the location of the initial insertion point of the interventional device, can also be determined. Therefore, the location of the initial insertion point of the interventional device can be determined in a 3D coordinate system using the shape sensing data provided by the shape sensing device 140. Assuming that the shape sensing data and the anatomical structure are located in the same 3D coordinate system, the location of the initial insertion point can be found without the need for additional medical imaging. Typically, as is known to those skilled in the art, the medical imaging 3D coordinate system (or anatomical 3D coordinate system) and the shape sensing 3D coordinate system must be aligned (or registered) in the same 3D coordinate system to know where the initial insertion point should be.

[0036] As described above, retainer 120 may provide at least one channel, for example, configured to receive an interventional instrument, thereby providing an entry trajectory for the interventional instrument at an initial insertion point on the subject's surface to guide the interventional instrument toward the target. In various embodiments, retainer 120 may be implemented using other compatible means, such as a clamping mechanism for holding the interventional instrument and then periodically releasing the interventional instrument according to the insertion step, so as to progressively drive the interventional instrument toward the target according to the entry trajectory, for example as described in U.S. Patent Application Publication No. 2016 / 0249991 entitled "Gripper for Robotic Image Guided Needle Insertion" (published September 1, 2016), which is hereby incorporated herein by reference in its entirety, wherein such retainer is integrated into a robotic system. The entry trajectory is the angle of entry of the interventional instrument relative to a plane defined by the bottom surface of the support structure 110 of the guide device 100 (which may be substantially the same as the plane defined by the outer surface of the subject). This entry trajectory, combined with the determination of the insertion point as described above, enables the determination of the position of the interventional device relative to the target within the subject's body, especially when the length of the interventional device is known.

[0037] Figure 1BThis is a plan view of a guide device having a shape sensing device attached to an interventional device, according to a representative embodiment, for guiding the interventional device to an internal target within a subject's body.

[0038] refer to Figure 1B An embodiment of the guiding device 100 is illustrated, wherein the distal end of the shape sensing device 140 is connected to the proximal end of the interventional device 150. The interventional device 150 is inserted into a channel or other trajectory guide formed by the retainer 120 with a selected entry trajectory. Since the shape sensing device 140 is connected to the interventional device 150, shape sensing data can also be used to determine the length, position, and orientation of the interventional device 150 in a 3D coordinate system. For example, when the shape sensing device 140 is connected to the interventional device 150, dynamic components (e.g., the z-axis of the interventional device 150) can be tracked.

[0039] Figure 2A and Figure 2B An embodiment of a retainer 120 for guiding an interventional device into a subject's body along a predetermined entry trajectory is illustrated. Specifically, Figure 2A This is a plan view of a retainer according to a representative embodiment, the retainer including a plurality of fixed guide channels corresponding to different entry trajectories for guiding interventional instruments, and Figure 2B This is a plan view of a retainer according to a representative embodiment, the retainer including a single pivoting guide channel providing a series of entry trajectories for guiding interventional instruments.

[0040] refer to Figure 2A The retainer 120 includes four fixed guide channels corresponding to four entry trajectories relative to a reference line L (shown as a dashed line) in a reference plane P, wherein the reference plane P is substantially perpendicular to the plane defined by the bottom surface of the support structure 110. In the illustrated example, the retainer 120 includes a first fixed channel 121 at a zero-degree angle to the reference line L, a second fixed channel 122 at a 30-degree angle to the reference line L, a third fixed channel 123 at a 45-degree angle to the reference line L, and a fourth fixed channel 124 at a 60-degree angle to the reference line L. Of course, the retainer 120 may include more or fewer fixed guide channels at the same or different angles without departing from the scope of the invention.

[0041] Figure 2ARepresentative interventional devices 150 (e.g., needles, cannulas, sheaths, introducers) are also shown, each with a different orientation corresponding to one of four different entry trajectories defined by insertion into a first fixed channel 121, a second fixed channel 122, a third fixed channel 123, and a fourth fixed channel 124. In practice, depending on the entry trajectory required to reach the target within the subject's body, the interventional device 150 will be inserted by the user into only one of the first fixed channel 121, the second fixed channel 122, the third fixed channel 123, and the fourth fixed channel 124 at a time. Furthermore, for illustrative purposes, the first fixed channel 121, the second fixed channel 122, the third fixed channel 123, and the fourth fixed channel 124 are all in a plane P that is substantially perpendicular to the reference plane defined by the support structure 110. In one embodiment, the interventional device 150 can be inserted into the intended channel by a robot configured to control the positioning and insertion of the interventional device.

[0042] refer to Figure 2B The retainer 120 includes a single pivot channel 125 configured to rotate within a plane P through a continuous range of access paths (indicated by arrows). For illustrative purposes, the plane P may be substantially perpendicular to the reference plane defined by the support structure 110. The pivot channel 125 can be rotatably connected to the support structure 110 via a pivot joint, which, for example, allows the pivot channel 125 to pivot through a continuous range of access paths. The access path of the interventional device 150 is set by the user selecting a chosen angle of the pivot channel 125 within the continuous range of access paths. In the illustrated example, the continuous range of access paths extends from approximately 60 degrees (e.g., negative) on one side of the reference line L (shown as a dashed line) to approximately 60 degrees (positive) on the other side of the reference line L, reaching a continuous range of approximately 120 degrees, where the reference line L is substantially perpendicular to the reference plane defined by the support structure 110. In one embodiment, the entry trajectory of the interventional device 150 can be set by a robot using a pivot channel 125, wherein the robot is configured to control the positioning and insertion of the interventional device.

[0043] The value of the selected angle can be identified by the user using a scale on the pivot channel 125 or other angle-encoded indicator. Furthermore, in embodiments where the distal end of the shape sensing device 140, as described above, is connected to the proximal end of the interventional device 150, the value of the selected angle can be identified using shape sensing data provided by the shape sensing device 140. For example, the position of the pivot channel 125 can be determined relative to the upper part of the outer frame 115, thereby indicating a first point corresponding to the distal end of the interventional device 150, and similarly, the position of the distal end of the shape sensing device 140 can be determined relative to the upper part of the outer frame 115 and / or the first point, thereby indicating a second point corresponding to the proximal end of the interventional device 150. The relative angle between the first and second points can then be calculated to provide the selected angle of the pivot channel 125.

[0044] Figure 3 This is a simplified block diagram of a guidance system according to a representative embodiment, the guidance system including a guidance device 100 and for guiding an interventional instrument 150 to a target within a subject's body.

[0045] refer to Figure 3 The guidance system 300 includes a guidance device 100, a shape sensing device 140, a processing unit 350, and a memory 352 for guiding an interventional device 150 to an internal target t within the body of a subject 310. In one embodiment, for example, the processing unit 350 and the memory 352 may be implemented in a controller. Moreover, in one embodiment, the interventional device 150 may be guided to the internal target t by a robot (not shown) in response to entry trajectory and positioning information provided by shape sensing data. For example, the target t may be a predetermined location in an artery or blood vessel within the leg of the subject 310, and the interventional device 150 may be a needle for entering the artery at the predetermined point. Alternatively, the target t may be, for example, a tumor, blood clot, or other abnormality, and the interventional device 150 may be a device for imaging, treating, and / or removing the abnormality. The shape sensing device 140 may be, for example, an OSS shape sensing device, which communicates with the processing unit 350 via a shape sensing interface 345 through a wired or wireless network connection. In other words, the shape sensing device 140 receives control commands from the processing unit 350 through the shape sensing interface 345 and provides shape sensing data to the processing unit 350.

[0046] The guidance system 300 communicates with the imaging device 320, which is configured to acquire images of the region of interest including the target t within the body of the subject 310, and to provide the corresponding image data to the processing unit 350. Before guiding the interventional device 150 to the target t using the guidance device 100, the imaging device 320 acquires at least one image of the target t. The image data is used to determine the initial position of the target t. The imaging device 320 can be any type of medical imaging device capable of providing images of internal targets, including, for example, an X-ray imaging device providing X-ray, CT, and / or fluoroscopic image data, an ultrasound imaging device providing ultrasound image data, or a magnetic resonance imaging (MRI) imaging device providing MRI images. The imaging device 320 communicates with the processing unit 350 via an imaging interface 325 through a wired or wireless network connection. That is, the imaging device 320 receives control commands from the processing unit 350 through the imaging interface 325 and provides imaging data to the processing unit 350 in response.

[0047] Shape sensing data provided by shape sensing device 140 is registered to image data provided by imaging device 320, such that the shape sensing data is provided in the same 3D coordinate system as the image data and the position of the target t in the image data. As known to those skilled in the art, this registration can be achieved in various ways. For example, registration can be performed using one or two X-ray images provided by imaging device 320, wherein shape sensing device 140 is visible in the field of view of the X-ray images. The 3D coordinate systems of imaging device 320 and shape sensing device 140 can then be aligned, thereby locating shape sensing device 140 using a manual process or automatic image processing algorithm that identifies a portion of shape sensing device 140 in the image, and knowing geometric information about imaging device 320 (X-ray system). Examples relating to the registration of shape sensing data and imaging data are provided in U.S. Patent Application Publication No. 2014 / 0114180 entitled “Live 3D Angiogram using Registration of a Surgical Tool Curve to an X-ray Image” (published April 24, 2014) and U.S. Patent Application Publication No. 2015 / 0254526 entitled “Three Dimensional Polyline Registration using Shape Coonstraints” (published September 10, 2015), which are incorporated herein by reference in their entirety.

[0048] The image may also include an image of all or part of the guiding device 100, which can help determine the relative initial position of the guiding device 100 and the target t. For example, assuming the imaging device 320 is an X-ray imaging device, Figure 4 An initial X-ray image of a target t located within an artery 430, taken by imaging device 320 according to a representative embodiment, is shown, with guide device 100 in the field of view. The X-ray image also shows a portion of shape sensing device 140, thereby enabling simultaneous visualization of the target t, guide device 100, and shape sensing device 140. Processing unit 350 is able to use image data from the X-ray image to determine the relative initial positions of guide device 100 and target T.

[0049] While the imaging device 320 provides real-time images throughout the guidance process, such as in the case of fluoroscopy or ultrasound imaging, the processing unit 350 can perform a dynamic, continuous re-registration process to compensate for deformable tissues within the subject 310. For example, when the target t is in a shifted position due to pressure induced by the guide device 100 on the skin surface of the subject 310 or due to the advancement of the interventional device 150 and / or being pushed to one side into a blood vessel, the target t will be in a shifted position. In this case, the processing unit 350 continuously updates the target position and similarly determines corresponding adjustments regarding the position and orientation of the guide device 100 and / or the interventional device 150.

[0050] In the illustrated embodiment, the processing unit 350, together with the memory 352, implements at least a portion of the method for guiding the interventional device 150 into the target t within the subject 310, and can be configured to execute and / or control Figure 9 All or part of the steps of the process shown herein are described below. In various embodiments, processing unit 350 may include one or more of a computer processor, digital signal processor (DSP), central processing unit (CPU), graphics processing unit (GPU), remote application programming interface (API), field-programmable gate array (FGA), application-specific integrated circuit (ASIC), or a combination thereof, thereby using any combination of hardware, software, firmware, hardwired logic circuitry, or a combination thereof. Processing unit 350 may include its own processing memory for storing computer-readable code (e.g., software, software modules, software engines) that enables the execution of the various functions described herein.

[0051] As used herein, the term "processor" encompasses any electronic component capable of executing programs or machine-executable instructions, and should be interpreted as including more than one processor or processing core, as in a multi-core processor. A processor can also refer to a collection of processors within a single computer system or distributed across multiple computer systems. A program has software instructions that are executed by one or more processors, which may be located within the same computing device or distributed across multiple computing devices.

[0052] Memory 352 refers to one or more memories and databases including processing memories, and multiple memories and databases including distributed and networked memories and databases. Memory 352 can be various types of random access memory (RAM), read-only memory (ROM), and / or other storage media, including flash memory, electrically programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), compact disc read-only memory (CD-ROM), digital versatile disc (DVD), registers, latches, triggers, hard disks, removable disks, magnetic tapes, floppy disks, Blu-ray discs, or Universal Serial Bus (USB) drives, or any other form of storage media known in the art that is tangible and non-transitory (e.g., compared to transiently propagating signals). As used herein, the term "non-transitory" should not be construed as a permanent characteristic of a state, but rather as a characteristic of a state that will persist for a period of time. The term "non-transitory" explicitly denies transient characteristics, such as the characteristics of a carrier wave or signal, or other forms that exist only temporarily at any time and place. Memory 352 can store software instructions and / or computer-readable code capable of performing various functions. The memory 352 may be volatile or non-volatile, secure and / or encrypted, or insecure and / or unencrypted, without departing from the scope of this teaching.

[0053] "Memory" and "database" are examples of computer-readable storage media and should be interpreted as potentially multiple memories or databases. As stated above, a memory or database can be, for example, multiple memories or databases local to a computer, and / or multiple memories or databases distributed among multiple computer systems or computing devices.

[0054] User interface 365 is configured to provide information and data output by processing unit 350 and / or memory 352 to a user and / or to receive information and data input by the user, and may include a network interface. That is, user interface 365 enables a user to input data and to control or manipulate multiple aspects of guiding interventional device 150 to target t, and also enables processing unit 350 to indicate the effects of the user's control or manipulation. User interface 365 may include one or more of ports, disk drives, wireless antennas, or other types of receiver circuitry. User interface 365 may also connect to one or more user interfaces, such as a mouse, keyboard, trackball, joystick, microphone, camera, touchpad, touchscreen, or voice or gesture recognition captured by a microphone or camera.

[0055] The display 360 can be a monitor, such as a computer monitor, television, liquid crystal display (LCD), organic light-emitting diode (OLED), flat panel display, solid-state display, or cathode ray tube (CRT) display or electronic whiteboard. The display 360 may include one or more display interfaces in conjunction with the user interface 365, in which case the display 360 can provide a graphical user interface (GUI) for displaying information to and receiving information from the user.

[0056] exist Figure 3 In this configuration, the distal end of the shape sensing device 140 is connected to the proximal end of the interventional device 150, as shown in the reference above. Figure 1B As discussed above. In this configuration, the processing unit 350 can determine additional information based on shape sensing data provided by the shape sensing device 140. For example, when the shape sensing device 140 is connected to the interventional device 150, the shape sensing data indicates the positions of the distal and proximal ends of the interventional device 150 in a 3D coordinate system, wherein the distal end of the interventional device 150 initially coincides with the position of the retainer 120 in the 3D coordinate system. Therefore, the processing unit 350 is able to calculate the length of the interventional device 150 by determining the difference between the distal and proximal ends.

[0057] Once determined (or otherwise known), the length of the interventional device 150 can be used to track the distal end (e.g., the tip of a needle) of the interventional device 150 as it advances through the guide device 100 into the body of the subject 310. That is, as the interventional device 150 advances through at least one channel of the guide device 100 toward the target t, the distance between the proximal end of the interventional device 150 and the retainer 120 shortens. The processing unit 350 is able to continuously determine this distance using shape sensing data. Therefore, the processing unit 350 can calculate the position of the distal end of the interventional device 150 by simply determining the remaining length of the interventional device 150 inside the subject and determining the distal end as the remaining length from the retainer 120 in the entry trajectory. Moreover, as described above, the processing unit 350 can calculate the entry trajectory of the interventional device 150 by determining the angle between the distance and the proximal end.

[0058] In various embodiments, in addition to imaging device 320, the guiding device may be integrated with another imaging device to receive real-time feedback on the movement of the interventional instrument via the guiding device. Figure 5A and Figure 5B These are top and bottom plan views of a guide device integrated with an ultrasound probe according to a representative embodiment, the guide device being used to guide interventional instruments to internal targets within a subject's body.

[0059] refer to Figure 5A and Figure 5BThe guiding device 100 is shown integrated with an ultrasound probe 520, which may be, for example, a portable wireless “puck” ultrasound probe, but may also include other types of ultrasound probes without departing from the scope of the invention. In the illustrated embodiment, the guiding device 100 and the ultrasound probe 520 are physically integrated and computationally integrated because, as described above, the guiding device 100 and the ultrasound probe 520 are registered to the same three-dimensional coordinate system. In an alternative embodiment, the guiding device 100 and the ultrasound probe 520 are integrated because they are registered to the same three-dimensional coordinate system, but they are not physically integrated (i.e., they are not attached or are physically separate).

[0060] More specifically, the ultrasound probe 520 is attached to the lower part of the outer frame 115 and is arranged such that the bottom surface of the ultrasound probe 520 is substantially coplanar with the bottom surface of the outer frame 115. Thus, the ultrasound probe 520 and the outer frame 115 are in close proximity to each other on the outer surface of the subject 310 in a fixed mechanical relationship. The ultrasound probe 520 emits sound waves into the subject 310 within a field of view 525 to obtain ultrasound images of the interventional device 150 and the target t, which, in the illustrated example, is located in the artery 530. The corresponding ultrasound image data can be transmitted to the processing unit 350 for processing via an ultrasound interface (not shown). Therefore, the progress of the interventional device 150 can be tracked in real time using both the shape sensing data provided by the shape sensing device 140 and the ultrasound probe 520. The target t and / or the blood vessel, artery, or other structure containing the target t can also be continuously tracked using the ultrasound probe 520 to monitor any deformation or movement. When the target t moves, this information can be determined by the processing unit 350, which updates the expected target position on the user interface 365 and / or the display 360.

[0061] The guiding device may also include visual, auditory, and / or tactile indicators to guide the user on how to move or redirect the guiding device so that the interventional instrument can be accurately advanced to the target. Figure 6 This is a plan view of a guide device with an indicator according to a representative embodiment, the guide device being used to guide an interventional instrument to an internal target within a subject's body.

[0062] refer to Figure 6The guiding device 100 also includes a representative indicator disposed on the fastener 130, configured to indicate the expected direction of rotation and / or expected repositioning of the guiding device 100 on the subject's outer surface in order to guide the interventional instrument to the target. Alternatively, the indicator may be disposed on the support structure 110 of the guiding device 100. In the illustrated example, the representative indicator is a visual indicator such as a light-emitting diode (LED), configured to emit light to indicate the expected direction of rotation of the guiding device 100 and / or the direction of movement of the guiding device 100 toward the expected position on the subject's surface. That is, a first visual indicator 631 is positioned at the top center of the support structure 110. A second visual indicator 632, a third visual indicator 633, and a fourth visual indicator 634 are arranged sequentially from the first visual indicator 631 along the left side of the fastener 130, and a fifth visual indicator 635, a sixth visual indicator 636, and a seventh visual indicator 637 are arranged sequentially from the first visual indicator 631 along the right side of the fastener 130. The first visual indicator 631 to the seventh visual indicator 637 are selectively illuminated to indicate to the user whether and how to move the guiding device 100 in order to properly guide the interventional instrument to the target.

[0063] The first visual indicator 631 through the seventh visual indicator 637 can be configured to be selectively illuminated in a rotation mode or a repositioning mode, which can be selected by the user, for example, via the processing unit 350. In rotation mode, the first visual indicator 631 illuminates when the guide device 100 is pointing in the correct direction. (Alternatively, no visual indicator is illuminated when the guide device 100 is pointing in the correct direction). This means that as the interventional instrument 150 advances through the retainer 120, it will bring the target into contact with the guide device in its current rotational orientation. When the guide device 100 is not pointing in the correct direction, the remaining visual indicators illuminate to indicate the direction and amount of rotation. Thus, the second, third, and fourth visual indicators 632-634 illuminate to indicate a counterclockwise rotation by the amount indicated by their respective positions. That is, the illumination of the second visual indicator 632 indicates a smaller amount of counterclockwise rotation compared to the illumination of the third visual indicator 633 or the fourth visual indicator 634. Similarly, the fifth, sixth, and seventh visual indicators 635-637 are illuminated to indicate clockwise rotation by the amount indicated by their respective positions. That is, the illumination of the fifth visual indicator 635 indicates a smaller amount of clockwise rotation compared to the illumination of the sixth visual indicator 636 or the seventh visual indicator 637. Alternatively, the first visual indicators 631 through the seventh visual indicator 637 can be illuminated in different colors to indicate the direction of rotation. For example, the selected visual indicator can be illuminated in green, while the unselected visual indicator can be illuminated in red.

[0064] To determine the amount of rotation, processing unit 350 determines the projected position of the distal end of interventional device 150 as it is guided through retainer 120 along the current entry trajectory with guide device 100 in its current orientation. The target position is known from initial image data, the orientation of guide device 100 is known from shape sensing data, and the length and orientation of interventional device 150 are known or can be determined from shape sensing data. The projected position will match the target position, or will be located to the left or right by the determined amount. Therefore, processing unit 350 can control a first visual indicator 631 to illuminate when the projected position matches the target position, can control one of the second to fourth visual indicators 632-634 to illuminate when the projected position is to the right of the target position by an amount corresponding to the illuminated visual indicator, and can control one of the fifth to seventh visual indicators 635 to illuminate when the projected position is to the left of the target position by an amount corresponding to the illuminated visual indicator. The user then manually rotates guide device 100 as indicated by the illuminated visual indicator.

[0065] In positioning mode, visual indicators are selectively illuminated based on the offset of the guide device 100 relative to the expected position to indicate the direction in which the user moves the guide device 100. Thus, the first visual indicator 631 is illuminated to indicate a planned forward movement of the guide device 100, one of the second, third, or fourth visual indicators 632-634 is illuminated to indicate a planned leftward movement of the guide device at a corresponding angle, and one of the fifth, sixth, or seventh visual indicators 635-637 is illuminated to indicate a planned rightward movement of the guide device at a corresponding angle. In one embodiment, the brightness and / or color of the illuminated indicators can also be adjusted to indicate the corresponding distance of the planned movement; for example, the brighter the indicator, the farther the guide device will move in the indicated direction to cover a larger offset. Alternatively, the first visual indicator 631 through the seventh visual indicator 637 can be illuminated in different colors to indicate the direction of repositioning. For example, the selected visual indicator indicating the expected direction of movement can be illuminated in green, while the unselected visual indicator can be illuminated in red.

[0066] To determine the amount of movement, processing unit 350 determines the projected position of the distal end of interventional device 150 as it is guided through retainer 120 along the current entry trajectory, given the current position of guide device 100 on the subject. Furthermore, the target position is known from the initial image data, and the initial position of guide device 100 on the surface of subject 310 is known from the shape sensing device 140 and the initial registration between shape sensing device 140 and the initial image data. Moreover, the orientation of guide device 100 is known from the shape sensing data, and the length and orientation of interventional device 150 are known or can be determined from the shape sensing data. The projected position will match the target position, or will be at a certain distance and direction from the target position. Therefore, processing unit 350 can control one of the first visual indicators 631 to the seventh visual indicator 637 to illuminate, thereby indicating the direction in which guide device 100 should be moved, such that interventional device 150 will intersect the target as it advances through retainer 120. The user then manually repositions guide device 100 as indicated by the illuminated visual indicator.

[0067] As described above, other types of indicators may be included to indicate the direction and amount of rotation and / or repositioning of the guide device 100 without departing from the scope of this teaching. For example, the indicator may be an audible indicator configured to emit sound to indicate the intended direction of rotation and / or direction toward the intended position of the guide device 100. Different audible indicators may have different volumes and / or tones to indicate the direction and / or amount of rotation or repositioning of the guide device 100. Alternatively, the indicator may be a tactile indicator configured to induce vibration to indicate the intended direction of rotation and / or direction toward the intended position of the guide device 100. Different tactile indicators may apply different vibration intensities to indicate the direction and / or amount of rotation or repositioning of the guide device 100.

[0068] As described above, another approach to using the fixable shape sensing device 140 to track the dynamic components of the interventional instrument 150 is to make the support structure 110 and the fastener 130 flexible. This flexibility allows the support structure 110 and the shape sensing device 140 to deform in any angular direction according to the interventional instrument 150 (when it is in the retainer 120), thereby increasing the degrees of freedom in the trajectory options provided by the retainer 120. For example, when the shape curvature from the shape sensing data is used to position the guide device 100, then the guide device 100 can be flexible, but a portion of it must retain the shape template used for identification. For example, refer to... Figure 6As long as the guide device 100 is relatively rigid between the second visual indicator 632 and the fifth visual indicator 635, this is sufficient to enable automatic positioning of the guide device 100 using shape sensing data. The rest of the guide device 100 can be more flexible, provided the distance between the tip of the guide device 100 (e.g., at the first visual indicator 631) and the needle insertion point at the retainer 120 is known. The guide device 100 can be more flexible overall when relying on axial strain or temperature changes for positioning. However, the distance between the point where the shape sensing device 140 is located in the guide device 100 and the needle insertion point must still be known.

[0069] Figure 7A , Figure 7B and Figure 7C This is a plan view of a deformable guide device 100A deformable in the lateral (right and left) direction according to a representative embodiment. All or part of the support structure 110 of the deformable guide device 100A is formed of a flexible material such as silicone rubber. The deformable guide device 100A is otherwise identical to the guide device 100 described above. Although not shown, it should be understood that a shape sensing device 140, such as an OSS device, will be fixed to a portion of the support structure 110 of the deformable guide device 100A to provide shape sensing data.

[0070] Figure 7A A deformable guide device 100a in a neutral orientation is shown, wherein the interventional instrument 150 is in a selected entry trajectory. Figure 7B A deformable guide device 100a is shown tilted to the right, while the interventional instrument 150 remains on the selected entry trajectory, allowing the interventional instrument 150 to be adjusted to enter the subject at an angle to the right of the centerline of the deformable guide device 100a. Similarly, Figure 7C A deformable guide device 100a tilted to the left is shown, while the interventional device 150 remains on the selected entry trajectory, thereby allowing the interventional device 150 to be adjusted to enter the subject at an angle to the left of the centerline.

[0071] Figure 8A , Figure 8B and Figure 8C This is a plan view of a deformable guide device 100B deformable in the longitudinal (upward and downward) direction according to a representative embodiment. Furthermore, all or part of the support structure 110 of the deformable guide device 100B is formed of a flexible material such as silicone rubber. The deformable guide device 100B is otherwise identical to the guide device 100 described above. Although not shown, it should be understood that a shape sensing device 140, such as an OSS device, will be fixed to a portion of the support structure 110 of the deformable guide device 100B.

[0072] Figure 8A A deformable guide device 100B in a neutral orientation is shown, wherein the interventional instrument 150 is in an entry trajectory of 30 degrees. Figure 8B A downwardly tilted deformable guide device 100B is shown for shallower insertion of the interventional instrument 150, thereby allowing the entry trajectory of the interventional instrument 150 to be adjusted to 15 degrees. Figure 8C A deformable guide 100B, tilted upwards, is shown for steeper insertion of the interventional instrument 150, allowing the entry trajectory of the instrument 150 to be adjusted to 45 degrees. In the illustrated example, the deformable guide 100B remains neutral in the lateral direction, allowing the interventional instrument 150 to enter the subject along the centerline of the deformable guide 100B. In one embodiment, the deformable guide can be configured for deformation in both lateral and longitudinal directions, thus combining the properties of deformable guides 100A and 100B.

[0073] Alternative visualization methods could include back projection onto the subject's skin. In this case, the initial image data may also include optical image data of the subject's skin, which is also registered to shape sensing data and image data from the imaging device 320. The target location can then be displayed on the subject's skin along with adjustment measurements for the guiding device 100.

[0074] Figure 9 This is a flowchart illustrating a method for guiding an interventional instrument to an internal target within a subject's body using a guiding device and a shape sensing device, according to a representative embodiment. The method can be implemented via computer-readable instructions or computer code (e.g., stored in memory 352 and executable by processing unit 350), as described above.

[0075] refer to Figure 9 In block S911, image data of a target (t) within the subject (310) is received from the imaging device (320), where the image data corresponds to an initial image of the subject taken by the imaging device. This image data can be, for example, X-ray, CT, fluoroscopy, ultrasound, or MRI image data, but may also include other types of medical imaging capable of providing image data of internal targets. The image may also include an image of a guiding device (100) located on the subject. In block S912, the image data is used to define the target's position in a 3D coordinate system and stored in memory (352). Target localization can be performed automatically, for example, by applying shape recognition algorithms or automatic labeling of anatomical structures to the image data, or it can be performed based on user input such as manually selecting a single point in the image to indicate the target's location.

[0076] In block S913, shape sensing data is received from a shape sensing device (140), such as an OSS device, indicating the shape of a portion of the shape sensing device attached to or inserted through a fastener (130) passing through the guide device. The shape sensing data may be, for example, FORS data. As described above, in block S914, the shape sensing device and the shape sensing data are registered to image data such that the shape sensing device and the image are in the same 3D coordinate system. In block S915, the registered shape sensing data is used relative to the image data to define the position and orientation of the guide device. Positioning and orientation can be performed automatically using the shape sensing data from the shape sensing device and stored in memory. Since the shape sensing device follows a known contour of the guide device (e.g., the upper part of the outer frame of the guide device), specific features (e.g., curvature) of the guide device can be identified as identifiable shape features using the shape sensing data. When the guide device is rigid or semi-rigid, the curvature contour of the guide device can be saved as a predefined template prior to this process. The received shape sensing data is processed (S913) and compared with the predefined template. A known matching algorithm (e.g., cross-association) is applied to identify a predefined template within the newly received shape sensing data. The position of the guide device is then determined as the location where a match occurs along the shape sensing device, and the orientation of the guide device is then determined, for example, based on features relative to that position.

[0077] The unique shape features of the outer frame of the guide device in the shape sensing data also help determine the orientation. For example, when the guide device has a uniquely shaped protrusion (131) at the top of the outer frame, the shape sensing data will capture the shape of the protrusion at that specific location and can extrapolate the position and orientation of the guide device (with known dimensions) from the protrusion location. Where the initial image data also shows the guide device, as described above, the unique arrangement of the cross supports within the outer frame will visually indicate the orientation of the guide device. For example, the first cross support (111) can connect the retainer (channel guide) (120) to the top of the outer frame such that the first cross support effectively points in the direction in which the interventional instrument will move as it advances through the retainer. Alternatively, the position and orientation of the guide device can be manually defined using a predefined template. Furthermore, the position of the guide device can be determined using the curvature / shape of the guide device and the shape sensing device attached to the guide device, or using axial strain / temperature. For example, a small thermal sensor can be placed at a point along the guide device where the shape sensing device is very close. Then, when there is an increase in axial strain due to temperature rise at the location of the thermal sensor, the corresponding position of the guiding device is known.

[0078] In frame S916, using shape sensing data and known dimensions of the guide device, the position of the interventional instrument is determined relative to a portion of the shape sensing device that is attached to or inserted through the guide device. Determining the position of the interventional instrument includes determining the entry point of the distal end of the interventional instrument at the retainer and the entry trajectory of the interventional instrument in a 3D coordinate system. Known dimensions may include, for example, the distance between the top of the outer frame and the position of the retainer, such that once the position of the top is determined from the shape sensing data, the entry point can be extrapolated based on the distance to the retainer. The entry trajectory can be determined based on values ​​of the entry trajectory selected and input by the user. Alternatively, when the shape sensing device is attached to the proximal end of the interventional instrument, as... Figure 1B As shown, shape sensing data can be used to calculate the length and entry trajectory of an interventional device in real time without user input. The calculation of the entry trajectory is known to those skilled in the art. For example, it can be assumed that the distal end of the interventional device coincides with the position of the retainer (entry point) determined using initial image data in a 3D coordinate system, and the proximal end of the interventional device can be determined using shape sensing data in the same 3D coordinate system. Geometry can then be used to determine the entry trajectory to find the relationship between the distal and proximal ends of the interventional device. Alternatively, the user or robot can define the entry trajectory based on the angles allowed by the retainer.

[0079] In block S917, adjustments to the position and orientation of the guide device and / or the trajectory angle of the interventional instrument can be optionally determined, the calculations of which are known to those skilled in the art. For example, the initial position of the target is known from block S912, the initial position and orientation of the guide device 25 is known from block S915, and the entry point and entry trajectory of the interventional instrument are known from block S916. Using the initial position of the target, the initial position and orientation of the guide device, and the entry point and entry trajectory of the interventional instrument, it can be geometrically determined whether the interventional instrument will intersect the target as it advances through the retainer on the current entry trajectory. When the interventional instrument advances from the guide device on the current entry trajectory at the current position and orientation, the calculated point where the distal end of the interventional instrument will be located can be displayed on the display for the user to observe.

[0080] If it is determined that the distal end of the interventional device does not intersect the target location, a new position and / or orientation of the guidance device is calculated in a 3D coordinate system using the geometric relationships between the known location of the target, the known entry trajectory, and alternative positions (movement of the guidance device along the subject's outer surface) and / or alternative orientations (rotation of the guidance device around the entry point). From this new position and / or orientation, the interventional device can be accurately advanced to the target with the known entry trajectory. Alternatively, a new entry trajectory can again be calculated in a 3D coordinate system using the geometric relationships, allowing the interventional device to be accurately advanced to the target with the existing position and orientation of the guidance device. Adjustments to the entry trajectory and / or adjustments to the current position and orientation relative to the new position, orientation, and / or angle are then calculated based on the current offset relative to the new position and / or orientation. These adjustments can be indicated to the user, for example, by indicators and / or displays showing the direction and amount of rotation and / or movement of the guidance device and / or the amount of angular correction of the interventional device. Then, after the calculated adjustments, the guiding device can be repositioned and / or reoriented, and / or the angle of the interventional device can be readjusted (e.g., by changing the angle setting or by deforming the guiding device).

[0081] In frame S918, indications of the defined positions of the guiding device and interventional instrument are superimposed on the initial image of the target on the display. Shape sensing data is used to track the advancement of the interventional instrument, and indications of the shape sensing data can also be displayed superimposed on the initial image. This allows the user or robot to manipulate the interventional instrument toward the target using image data, meaning that additional images captured by the imaging device are not required.

[0082] According to various embodiments of this disclosure, the methods described herein can be implemented using a hardware computer system that executes software programs. Furthermore, in exemplary, non-limiting embodiments, implementations may include distributed processing, component / object distributed processing, and parallel processing. Virtual computer system processing can implement one or more of the methods or functions described herein, and the processors described herein can be used to support virtual processing environments.

[0083] Although the developed adaptive predictive analysis has been described with reference to several exemplary embodiments, it should be understood that the terms used are descriptive and illustrative, not limiting. Changes may be made within the scope of the appended claims (as hereby stated and modified) without departing from the scope of optimization of the interventional procedure in its various aspects. While the developed adaptive predictive analysis has been described with reference to specific devices, materials, and embodiments, it is not intended to be limited to the disclosed details; rather, it extends to all functionally similar structures, methods, and uses, for example, within the scope of the appended claims.

[0084] The illustrations of the embodiments described herein are intended to provide a general understanding of the structure of the various embodiments. These illustrations are not intended to be a complete description of all elements and features of the disclosure described herein. Many other embodiments will be apparent to those skilled in the art upon review of this disclosure. Other embodiments may be utilized and derived from this disclosure, allowing for structural and logical substitutions and changes without departing from the scope of this disclosure. Furthermore, these illustrations are representative only and may not be drawn to scale. Some scales in the illustrations may be exaggerated, while others may be minimized. Therefore, this disclosure and the accompanying drawings should be considered illustrative rather than restrictive.

[0085] One or more embodiments of this disclosure may be referred to herein, individually and / or collectively, by the term "invention," merely for convenience and not intended to voluntarily limit the scope of this application to any particular invention or inventive concept. Furthermore, although specific embodiments have been illustrated and described herein, it should be understood that any subsequent arrangements designed to achieve the same or similar purpose may replace the specific embodiments shown. This disclosure is intended to cover any and all subsequent changes or variations of the various embodiments. Combinations of the above embodiments and other embodiments not specifically described herein will be apparent to those skilled in the art after reviewing this specification.

[0086] Furthermore, in the preceding detailed description section, for the purpose of simplifying the disclosure, features may be grouped together or described together in a single embodiment. This disclosure should not be construed as reflecting an intention that the claimed embodiments require more features than those expressly recited in each claim. Rather, as reflected in the following claims, the inventive subject matter may address fewer than all features in any of the disclosed embodiments. Therefore, the following claims are incorporated into the detailed description section, wherein each claim independently defines a separately claimed subject matter.

[0087] The foregoing description of the disclosed embodiments is intended to enable any person skilled in the art to practice the concepts described in this disclosure. Therefore, the subject matter disclosed above is to be considered illustrative rather than restrictive, and the appended claims are intended to cover all such modifications, enhancements, and other embodiments falling within the scope of this disclosure. Accordingly, to the maximum extent permitted by law, the scope of this disclosure shall be determined by the broadest permissible interpretation of the following claims and shall not be bound or limited by the foregoing detailed description.

Claims

1. A system for guiding an interventional device (150) to an internal target (t) within a subject (310), the system comprising: A guiding device (100) configured to be placed on the outer surface of the subject (310), the guiding device (100) comprising: At least one retainer (120) configured to receive the interventional instrument (150) and guide the interventional instrument (150) to the target (t) according to the entry trajectory; and Fastener (130), which is attached to or can be attached to a portion of a fixed shape having at least one identifiable shape feature of the guide device (100); and A shape sensing device (140) is fixed to the guide device (100) by the fastener (130) when the fastener (130) is attached to the portion of the guide device (100), such that at least a portion of the shape sensing device (140) fixed to the guide device (100) has the fixed shape with the at least one identifiable shape feature, the shape sensing device (140) is arranged to provide shape sensing data relating to the fixed shape of the at least portion of the shape sensing device (140) fixed to the guide device (100) by the fastener (130), wherein one end of the shape sensing device (140) is arranged to be attachable to the interventional device (150).

2. The system according to claim 1, wherein, The system also includes: A processing unit (350) and a memory (352) for storing instructions, which, when executed by the processing unit (350), cause the processing unit (350) to: Image data is received from an image of the target (t) within the body of the subject (310); The image data is used to define the position of the target (t) in the coordinate system; Receive the shape sensing data from the shape sensing device (140); The shape sensing data is used to determine the position and orientation of the guiding device (100) in the coordinate system; The shape sensing data is used to determine the position of the interventional instrument (150) relative to the shape sensing device (140) of at least a portion secured to the guide device (100) by the fasteners, the position including the entry point and entry trajectory of the interventional instrument (150); and Provides an indication of the determined position of the interventional device (150) in the coordinate system, which can be used by the user interface (365) to enable a user or robot to manipulate the interventional device toward the target.

3. The system according to claim 1, wherein, The system further includes a processing unit (350) and a memory (352) for storing instructions, which, when executed by the processing unit (350), cause the processing unit (350) to: Image data is received from an image of the target within the body of the subject (310); The position and orientation of the guiding device (100) are registered to the image data using the shape sensing data; Determine the adjustment of the guiding device (100) on the outer surface of the subject (310) such that the entry trajectory of the interventional device (150) will guide the interventional device (150) to the target (t); and Adjustment parameters are provided to enable the determined adjustment.

4. The system according to claim 1, wherein, The shape sensing device (140) includes an optical shape sensing device (140).

5. The system according to claim 1, wherein, The fastener (130) includes a sleeve through which the shape sensing device (140) can be inserted. The sleeve is attached to or can be attached to a portion of at least one identifiable shape feature of the guide device (100) so that the guide device (100) can be detected when the shape sensing device (140) is inserted through the sleeve.

6. The system according to claim 1, wherein, The guiding device (100) is deformable in at least one of the lateral or longitudinal directions, thereby enabling adjustment of the interventional instrument (150).

7. The system according to claim 1, wherein, The at least one retainer (120) is arranged such that a plurality of discrete angular positions of the interventional device (150) are selectable, the plurality of discrete angular positions corresponding to a plurality of angles relative to the outer surface of the subject (310).

8. The system according to claim 1, wherein, The at least one retainer (120) is arranged to have a pivot joint that is movable relative to the outer surface of the subject (310) through a continuous range of angles.

9. The system according to claim 1, wherein, The at least one retainer (120) is arranged to have a pivot joint that is movable relative to the outer surface of the subject (310) through a continuous range of angles.

10. The system according to claim 2, wherein, The guiding device can be connected to an ultrasound probe (520) configured to acquire ultrasound images of the interventional instrument (150) in the region of interest and / or ultrasound images of the target (t), and When the instruction is executed by the processing unit (350), the instruction also causes the processing unit (350) to continuously update the position and / or entry trajectory of the target (t) using ultrasound image data from the ultrasound image.

11. The system according to claim 1, wherein, The system also includes: A plurality of indicators (631, 632, 633, 634, 635, 636, 637) are located on the guide device (100), the plurality of indicators being configured to indicate the expected rotation direction and / or expected position of the guide device (100) on the outer surface of the subject (310).

12. The system according to claim 11, wherein, The plurality of indicators (631, 632, 633, 634, 635, 636, 637) include: Multiple light-emitting diodes (LEDs) are configured to emit light to indicate the intended rotation direction of the guide device (100) and / or the direction of movement of the guide device (100) toward the intended position; Multiple auditory sensors are configured to emit sound to indicate the expected rotation direction of the guide device (100) and / or the direction of movement of the guide device (100) toward the expected position; or Multiple tactile sensors are configured to induce vibrations to indicate the intended rotation direction of the guide device (100) and / or the direction of movement of the guide device (100) toward the intended position.

13. The system according to claim 2, wherein, The image data includes: X-ray image data, CT image data, or fluorescence fluoroscopy image data from an X-ray system are registered with the shape sensing device (140); Ultrasonic image data from the ultrasound system, which is registered with the shape sensing device (140); or Magnetic resonance imaging (MRI) image data from an MRI system, which is registered with the shape sensing device (140).

14. The system according to claim 1, wherein, The system also includes a processing unit (350) programmed to determine the position and orientation of the guide device (100) on the outer surface of the subject (310) based on the shape sensing data.

15. The system according to claim 11, wherein, The system also includes a processing unit (350) programmed to determine the position and orientation of the guide device (100) on the outer surface of the subject (310) based on the shape sensing data.

16. The system according to claim 1, wherein, The system further includes a processing unit (350) programmed to determine the position of the interventional instrument (150) relative to the shape sensing device (140) of at least a portion of the portion fixed to the guide device (100), the position including the entry point and entry trajectory of the interventional instrument (150).

17. The system according to claim 14, wherein, The system also includes: A display (360) connected to the processing unit (350) is used to display a representation of the guiding device (100) that overlaps with an image of the target (t) within the body of the subject (310).

18. The system according to claim 16, wherein, The system also includes: A display (360) connected to the processing unit (350) is used to display a representation of the interventional device (150) superimposed on an image including the target (t) within the body of the subject (310).

19. A system for guiding an interventional device (150) to an internal target (t) within a subject (310), the system comprising: A guiding device (100) configured to be placed on the outer surface of the subject (310), the guiding device (100) comprising: At least one retainer (120) configured to receive the interventional instrument (150) and guide the interventional instrument (150) to the target (t) according to the entry trajectory; and Fastener (130), which is attached to or can be attached to a portion of a fixed shape having at least one identifiable shape feature of the guide device (100); and An optical shape sensing device (140), which is fixed to the guide device (100) by the fastener (130), such that at least a portion of the optical shape sensing device (140) fixed to the guide device (100) has the fixed shape with the at least one identifiable shape feature, wherein one end of the optical shape sensing device (140) is arranged to be attachable to the interventional instrument (150); and A processing unit (350) and a memory (352) for storing instructions, which, when executed by the processing unit (350), cause the processing unit (350) to: Image data is received from the image of the target (t) inside the body of the subject (310); The location of the target (t) is defined using the image data; Shape sensing data is received from the optical shape sensing device (140), the shape sensing data indicating the shape of the at least portion of the optical shape sensing device (140) fixed to the guide device (100); The shape sensing data is used to determine the position and orientation of the guide device (100); and An indication of the position of the interventional device (150) that overlaps with the image of the target (t) is displayed on the display (360), thereby enabling the interventional device (150) to be manipulated toward the target (t) using the image data.

20. The system according to claim 19, wherein, When the instruction is executed by the processing unit (350), the instruction also causes the processing unit (350) to: The shape sensing data is used to determine the position of the interventional instrument (150) relative to the optical shape sensing device (140) and the at least portion of it that is fixed to the guide device (100), the position including the entry point and the entry trajectory of the interventional instrument (150).

21. The system according to claim 19, wherein, The guiding device (100) is deformable in at least one of the lateral and longitudinal directions, thereby enabling adjustment of the interventional instrument (150).

22. The system according to claim 19, wherein, The instruction also causes the processing unit (350) to: The position and orientation of the guiding device (100) are registered to the image data using the shape sensing data; Determine the adjustment of the guiding device (100) on the outer surface of the subject (310) such that the entry trajectory of the interventional device (150) will guide the interventional device (150) to the target (t); and Adjustment parameters are provided for manipulating the interventional device (150) toward the target (t).

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