Patent Application
20170354387
The subject matter disclosed herein relates to the field of image-guided interventional devices and methods, and more specifically to guiding devices and techniques utilized with the interventional devices and methods.
Interventional devices, procedures and methods are used in a variety of situations, such as providing the necessary treatment or diagnostic interaction with the tissue or region of interest within the patient but in a minimally invasive manner, thereby greatly lessening the trauma and recovery time for the patient undergoing the procedure or treatment. As a result, these minimally invasive medical interventional devices, procedures and methods are becoming increasingly important in the treatment of various conditions, including coronary heart disease and are also increasing in the field of biopsies, spinal column treatments and tumor ablations.
In a minimally invasive interventional procedure, one or more medical devices, e.g., a needle, are introduced into the body of a patient for treatment or diagnostic purposes. After the initial insertion of the needle into the patient's body, at least the tip of the needle is no longer visible for a physician performing the interventional procedure. In order to navigate the needle within the body of the patient, the needle must therefore be visualized in a suitable way to illustrate the position of the needle to enable the clinician to move the needle to the desired area of interest within the patient.
Various systems and methods are available today for determining the position of the instrument in the patient's body during minimally invasive medical interventions, which is necessary for visualizing the instrument, in particular the tip of the instrument, in image information from inside the patient's body. Some examples of these types of systems and methods are illustrated in U.S. Pat. No. 6,487,431 entitled Radiographic Apparatus And Method For Monitoring The Path Of A Thrust Needle and US Patent Application Publication No. US2008/0200876 entitled Needle Guidance With Dual-Headed Laser, both of which are expressly incorporated by reference herein in their entirety for all purposes. These systems and methods involve the use of image information obtained on the body region acquired preoperatively or intraoperatively by an imaging system, such as a computed tomography scanner, a magnetic resonance device or a C-arm X-ray device as 2D images, or as a 3D image. The information provided by the images can be utilized to assist the clinician in determining an appropriate insertion path along which to insert the interventional device into the patient. The initial point of the insertion path on the skin of the patient can be illuminated by a laser or other suitable light emitting device to enable the clinician to insert the device at the proper starting point. The imaging system can then obtain addition image information on the positioning of the device relative to the area of interest to guide the device.
However, certain significant issues are present with regard to these prior art systems and methods relates to the laser utilized to illuminate the insertion point on the skin of the patient. For example, in those systems where the laser is aligned coaxially with the imaging system, i.e., in a bull's-eye view where the laser and the X-ray beam emitted by the imaging system to strike the detector are coaxial, depending upon the position of the body of the patient, the area of interest within the patient, and the desired path of insertion, it may not be possible to position the imaging system at the proper location to enable the laser to illuminate the entry point on the patient.
A further drawback of the coaxial position of the laser and the X-ray beam is that, because the point identified by the laser is positioned within the imaging field defined by the imaging system, the clinician must place his or her hands within the field in order to properly locate the interventional device on the patient. Doing so necessarily exposes the clinician to the radiation from the imaging system which is detrimental to the clinician, unless the clinician is utilizing an extender for the device, which necessarily limits the effectiveness of the positioning of the device by the clinician.
To address this issue, other prior art systems have been developed in which the laser is disposed on an armature separate from the imaging system, such as on a robotic arm. The arm can be positioned in order to illuminate the entry point on the patient for the interventional device, without need to be coupled to the imaging system. However, in these systems the clinician has to assume that the armature has properly positioned the laser with regard to the patient to illustrate the entry path, which is often not the case due to errors with regard to the operation of the system.
There is a need or desire for a system and method that can provide images for the guidance of an interventional device used in a minimally invasive surgical procedure that does not include the above-mentioned drawbacks and needs in the prior art. These issues are addressed by the embodiments described herein in the following description of the invention, which is a system and method for increasing the angular positions for the detector in which the procedure can be performed and without the need for the clinician/physician performing the procedure to place their hands within the beam striking the detector.
In the exemplary embodiments of the system and associated method, an imaging system utilized to obtain X-ray/fluoro images of the area of interest and the position of the interventional device within the patient includes one or more light sources or emitters, e.g., lasers, positioned on the detector for the imaging system. The lasers are positioned in multiple different offset locations with regard to the detector, such that the lasers are not coaxial with the X-ray beam. This positioning enables each laser to direct a laser beam at a location on the patient within the X-ray beam generated by the imaging system that enables the physician to access the point indicated by the laser beam with a tool without obstructing the view of the positioning laser and without the physician having to place their hands within the field of the X-ray beam. Further, the offset location of the laser enables the detector to be positioned at locations relative to the patient where the laser can project an entry point for the tool on the patient that were previously not possible with prior art coaxial systems. In addition, the system and method allows the clinician/physician to position the tool while simultaneously using the imaging system to check the position/depth of the interventional device as it is moved towards the area of interest.
According to one exemplary embodiment of the invention, a system for image-guided navigation of a tool is provided that includes an X-ray source capable of emitting an X-ray beam, an X-ray collimator capable of limiting the beam extent, an X-ray detector capable of detecting the X-ray beam on a first position of the detector and a light emitting device disposed on the detector in a second position, wherein the second position is offset from the first position.
According to another exemplary embodiment of the invention, a method of providing image-guided navigation during a medical procedure includes the steps of providing an image-guided navigation system including a movable gantry on which is disposed an X-ray source capable of emitting an X-ray beam, an X-ray detector capable of detecting the X-ray beam on a first position of the detector and a light source disposed on the detector in a second position, wherein the second position is offset from the first position, a target support disposed within the field of movement of the gantry and a system controller including a user input operably connected to the gantry, the X-ray source, the X-ray detector, the laser and the target support, operating the X-ray source and X-ray detector to obtain at least one image of a target within a body, determining an optimal trajectory for the insertion of a tool into the body to intersect the target, positioning the gantry to locate the light source at a point where a light beam is emitted from the light source along the optimal trajectory outside of the X-ray beam.
According to another exemplary embodiment of the invention, a method of providing image-guided navigation of a tool includes the steps of providing an image-guided navigation system including a movable gantry on which is disposed an X-ray source capable of emitting an X-ray beam, an X-ray detector capable of detecting the X-ray beam on a first position of the detector and a laser disposed on the detector in a second position, wherein the second position is offset from the first position, a target support disposed within the field of movement of the gantry and a system controller including a user input operably connected to the gantry, the X-ray source, the X-ray detector, the laser and the table, operating the X-ray source and X-ray detector to obtain at least one image of a target within a body, determining an optimal trajectory for the insertion of a tool into the body to intersect the target, positioning the gantry to locate the laser at a point where a laser beam is emitted from the laser along the optimal trajectory, marking a calculated entry point on the body with the laser beam along the optimal trajectory, positioning a tip of the tool at the entry point, aligning the tool with the laser beam marking the optimal trajectory, inserting the tool into the body at the entry point along the optimal trajectory and obtaining an image of a position of the tool and the target within the body to compare with the optimal trajectory.
It should be understood that the brief description above is provided to introduce in simplified form a selection of concepts that are further described in the detailed description. It is not meant to identify key or essential features of the claimed subject matter, the scope of which is defined uniquely by the claims that follow the detailed description. Furthermore, the claimed subject matter is not limited to implementations that solve any disadvantages noted above or in any part of this disclosure
The drawings illustrate the best mode presently contemplated of carrying out the disclosure. In the drawings:
In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments, which may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments, and it is to be understood that other embodiments may be utilized and that logical, mechanical, electrical and other changes may be made without departing from the scope of the embodiments. The following detailed description is, therefore, not to be taken in a limiting sense.
Exemplary embodiments of the invention disclosed herein relate to a system and method for identifying an optimal trajectory for the insertion of an interventional device into a patient and displaying the position of the device as it is inserted into the body of the patient towards an area of interest.
The system and method disclosed herein may be suitable for use with a range of imaging and navigation systems. To facilitate explanation, the present disclosure will primarily discuss the invention in the context of a C-arm fluoroscopic system. However, it should be understood that the following discussion may also be applicable to other and navigation systems.
With this in mind, an example of a C-arm fluoroscopic imaging and navigation system 10 designed to acquire X-ray attenuation data at a variety of views around a patient and suitable for tomographic reconstruction is provided in
The collimator 14 permits X-rays 16 to pass into a region in which a patient 18, is positioned. In the depicted example, the X-rays 16 are collimated to be a cone-shaped or pyramidal-shaped beam, i.e., a cone-beam, that passes through the imaged volume of the patient 18 containing the area of interest or target T. A portion of the X-ray radiation beam 20 passes through or around the patient 18 (or other subject of interest) and impacts a detector array, represented generally at reference numeral 22. Detector elements of the array produce electrical signals that represent the intensity of the incident X-rays 20. These signals are acquired and processed to reconstruct images of the features within the patient 18.
Source 12 is controlled by a system controller 24, which furnishes both power, and control signals for the examination sequences. In the depicted embodiment, the system controller 24 controls the source 12 via an X-ray controller 26 which may be a component of the system controller 24. In such an embodiment, the X-ray controller 26 may be configured to provide power and timing signals to the X-ray source 12.
Moreover, the detector 22 is coupled to the system controller 24, which controls acquisition of the signals generated in the detector 22. In the depicted embodiment, the system controller 24 acquires the signals generated by the detector using a data acquisition system 28. The data acquisition system 28 receives data collected by readout electronics of the detector 22. The data acquisition system 28 may receive sampled analog signals from the detector 22 and convert the data to digital signals for subsequent processing by a processor 30 discussed below. Alternatively, in other embodiments the digital-to-analog conversion may be performed by circuitry provided on the detector 22 itself. The system controller 24 may also execute various signal processing and filtration functions with regard to the acquired image signals, such as for initial adjustment of dynamic ranges, interleaving of digital image data, and so forth.
In the embodiment illustrated in
The linear and rotational positioning subsystem 34 may enable the patient 18, or more specifically a table supporting the patient, also called the target support, to be displaced within the imaging field of view of the system 10. Thus, the table may be linearly or rotationally moved (in a continuous or step-wise fashion) within the gantry to generate images of particular areas of interest or target T within the patient 18. In the depicted embodiment, the system controller 24 controls the movement of the gantry 32 and/or the positioning of the table 34 via a motor controller 36.
In general, system controller 24 commands operation of the imaging system 10 (such as via the operation of the source 12, detector 22, and positioning systems described above) to execute examination protocols and to process acquired data. For example, the system controller 24, via the systems and controllers noted above, may rotate a gantry supporting the source 12 and detector 22 about an area of interest or target T so that X-ray attenuation data may be obtained at a variety of views relative to the target T. In the present context, system controller 24 may also include signal processing circuitry, associated memory circuitry for storing programs and routines executed by the computer (such as routines for executing image processing techniques described herein), as well as configuration parameters, image data, and so forth.
In the depicted embodiment, the image signals acquired and processed by the system controller 24 are provided to a processing component 30 for reconstruction of images. The processing component 30 may be one or more conventional microprocessors. The data collected by the data acquisition system 28 may be transmitted to the processing component 30 directly or after storage in a memory 38. Any type of memory suitable for storing data might be utilized by such an exemplary system 10. For example, the memory 38 may include one or more optical, magnetic, and/or solid state memory storage structures. Moreover, the memory 38 may be located at the acquisition system site and/or may include remote storage devices for storing data, processing parameters, and/or routines for image reconstruction, as described below.
The processing component 30 may be configured to receive commands and scanning parameters from an operator via an operator workstation 40, typically equipped with a keyboard and/or other input devices. An operator may control the system 10 via the operator workstation 40. Thus, the operator may observe the reconstructed images and/or otherwise operate the system 10 using the operator workstation 40. For example, a display 42 coupled to the operator workstation 40 may be utilized to observe the reconstructed images and to control imaging. Additionally, the images may also be printed by a printer 44 which may be coupled to the operator workstation 40.
Further, the processing component 30 and operator workstation 40 may be coupled to other output devices, which may include standard or special purpose computer monitors and associated processing circuitry. One or more operator workstations 40 may be further linked in the system for outputting system parameters, requesting examinations, viewing images, and so forth. In general, displays, printers, workstations, and similar devices supplied within the system may be local to the data acquisition components, or may be remote from these components, such as elsewhere within an institution or hospital, or in an entirely different location, linked to the image acquisition system via one or more configurable networks, such as the Internet, virtual private networks, and so forth.
It should be further noted that the operator workstation 40 may also be coupled to a picture archiving and communications system (PACS) 46. PACS 46 may in turn be coupled to a remote client 48, radiology department information system (RIS), hospital information system (HIS) or to an internal or external network, so that others at different locations may gain access to the raw or processed image data.
While the preceding discussion has treated the various exemplary components of the imaging system 10 separately, these various components may be provided within a common platform or in interconnected platforms. For example, the processing component 30, memory 38, and operator workstation 40 may be provided collectively as a general or special purpose computer or workstation configured to operate in accordance with the aspects of the present disclosure. In such embodiments, the general or special purpose computer may be provided as a separate component with respect to the data acquisition components of the system 10 or may be provided in a common platform with such components. Likewise, the system controller 24 may be provided as part of such a computer or workstation or as part of a separate system dedicated to image acquisition.
Referring now to
Each laser 50 is mounted to the detector 22 at a static and known position, such that the system 10 includes a value for the offset angle and distance that the laser 50 is positioned from the center of the X-ray beam 20 striking the detector 22. However, in another exemplary embodiment, the laser(s) 50 can be movably positionable relative to the detector 22. In this exemplary embodiment, once the laser(s) 50 is in the desired position, the system 10 determines the location (e.g., the offset angle and distance) of each laser 50 relative to the detector 22 for use in the procedure to be performed utilizing the system 10.
Looking at
Once the optimal trajectory 64 is determined, in block 102 the system controller 24 determines the gantry 32 and patient support 34 position for the Bull's Eye view as well as for the “Laserview” and a Progress view used by the system 10. The Laserview is defined by the location of the detector 22 relative to the patient 18 where the selected laser 50 is positioned to illuminate the entry point 63 by directing the laser beam 58 along the computed optimal trajectory 64 to the target T, as shown in
The Laserview position is achieved by adjusting the gantry 32 and patient support/table 34 linearly and/or rotationally to align the laser beam 58 with the desired angles for the trajectory 64. The position of each angle/axis is determined by the system controller 24 using the trajectory (α,β) determined at step 100 offset by the known angle/position of the laser 50 relative to the detector 22. In one exemplary embodiment, the gantry 32 and table 34 provide up to 5 extra degrees of freedom (2 rotations and 3 translations) enabling multiple solutions for the Laserview position to be determined, in which case, the system controller 24 selects an optimal position given the clinical task/procedure to be performed as indicated to the system 10 by the operator. The Laserview can be reached by the movement of the gantry 32 alone, provided that it has 2 rotational and 3 translational degrees of freedom such as the Discovery IGS 740 from GE Healthcare. However, many implementations will have the gantry 32 provide the 2 rotational degrees of freedom and the patient support/table 34 provide the 3 translational degrees of freedom.
In determining the Laserview configuration for the source 12 and detector 22, the system controller 24 additionally determines which laser 50 should be aligned to the trajectory 64 based on whether the position for the detector 22 at that trajectory 64 is reachable or not due to potential interference/collisions, for example between the detector 22 and/or tube 12 and the patient 18 and/or table 34 on which the patient is positioned and in order to optimize the access of the physician 62 at that trajectory 64, as shown in
After the Laserview to be utilized in the procedure has been determined, in block 102 the system controller 24 can optionally operate rotational subsystem 26 to position the source 12 and the detector 22 in a Bull's-eye view configuration relative to the trajectory 64 where the target T is centered in the image, if this view is reachable. At this position one or more images are taken at this position to verify the location of the target T and that the patient 18 has not moved thereby confirming the trajectory 64. If the Bull's eye view is not reachable, other suitable views such as two orthogonal views can be used.
Once the position of the target T and patient 18 has been confirmed, the method proceeds to block 104 where the system controller 24 moves the source 12 and detector 22 back to the Laserview configuration where the physician places the tip 61 of the interventional device/needle 60 at the entry point 63 indicated by the beam 58 emitted from the laser 50.
In block 106 the physician then moves the device 60 in order to align the device 60 with the trajectory 64 indicated by the angles of the beam 58 relative to the entry point 63, while keeping the tip 61 on the entry point 63, schematically shown in
As the physician is inserting the device 60 into the patient 18, upon the request of the physician, in block 110 the system controller 24 can position the gantry 32 and/or table 34 at the Laserview or Progress view. In doing so, the system controller 24 can take one or more additional images of the patient 18 in order to display the position of the tip of the device 60 relative to the trajectory 64 and to the target T. In the Laserview configuration, with the only assumption being that the device 60 is inserted at the entry point 63 and aligned with the laser beam 58, the system controller 24 can readily illustrate to the physician the three-dimensional position and depth of the device 60 along the trajectory 64 simultaneously with the physician holing the device 60 to assist in guiding the device 60 to the target T. This can be shown to the physician on the display 42, optionally with the image taken in the Laserview position used as an overlay over a three-dimensional image of the planned trajectory through the patient 18 compiled from prior images. From this combined image, the system controller 24 can indicate to the physician the exact position of the device 60 in the patient 18, accuracy of the insertion of the device 60 along the trajectory 64, can identify any corrections that need to be made to the device 60 placement, and can display the remaining distance between the device 60 and the target T, among other suitable information concerning the procedure.
Alternatively, where the image is obtained in a Progress view configuration for the source 12 and detector 22, the system controller 24 moves the gantry 32 to the appropriate position to obtain the Progress view image, and then optionally returns the gantry 32 to the Laserview position. The Progress view image can then be used by itself or with the three-dimensional trajectory planning image to enable the physician to see the device 60 as it is being manipulated and its position in the patient 18 relative to the planned trajectory 64. Also, switching between these view configurations can provide access to more information at a lower dose while maintaining the accuracy.
After insertion of the device 60 in block 110, or as another check prior to the insertion of the device 60, the physician can request that the system controller 24 perform a check on the position of the patient 18 in order to determine that the patient 18 is still in the proper position relative to the planned trajectory 64. To do so, in block 112, upon the request of the physician, the system controller 24 operated the gantry 32 and/or or the table 34 to place the source 12 and detector 22 in one or more suitable views, potentially including the Bull's-eye view configuration. The system controller 24 then operates the source 12 and detector 22 to obtain an image is taken of the target T and check that the target T is at the proper location relative to the planned trajectory 64.
The written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.
