Patent Application
20190343590
This disclosure relates generally to medical procedures and, more specifically, to template systems and methods using the same for image-guided medical procedures.
Targeted procedures to aim suspicious foci visible in Magnetic Resonance Imaging (MRI) have been proposed as a strong alternative to other systematic non-targeted procedures. MRI provides improved imaging characteristics and an increased ability to define suspicious areas and detect, characterize, and stage potentially harmful tissue (e.g., cancerous tissue). Additionally, MRI provides superior visualization of suspicious foci and can both target and guide treatment and diagnostic apparatus to the foci enabling image targeted/guided procedures.
Examples of procedures of interest in this field include but are not limited to biopsies, ablations, or brachytherapy. These procedures can be performed under ultrasound, X-ray Computed Tomography (CT), or MRI guidance. In case of ultrasound or CT-guided procedures, the MRI taken before the procedures but also used to define the foci, will be digitally fused to intra-operative ultrasound or CT. This image fusion helps physicians to localize foci in the ultrasound or CT, which otherwise cannot localize the foci. In case of MRI-guided procedures, MRI taken before the procedure but also used to define the foci, can be also fused to intra-operative MRI to identify target foci in the intra-operative MRI. One can also use intra-operative MRI only to set foci to aim in the procedures.
Currently, the foci can be aimed by diagnostic and therapeutic tools using a perforated template tool guide with a pre-defined tool-guide holes having discrete spacing between holes. This discrete spacing between holes a template limits the accuracy of tool placement in targeted approaches, since MRI can localize suspicious foci in higher resolution than pre-defined hole pattern can handle. Additionally, clinician error can also occur because the clinician is responsible for counting small diameter holes in order to correctly place needles.
Therefore, there is a need to make an improved template system that can aim the foci with targeting resolution close to that of MRI.
The present disclosure provides systems and methods for using a template system for an image-guided medical procedure. In particular, systems and methods are provided for a system to create a patient specific template for guiding a diagnostic and therapeutic tools with the assistance of MRI. The template is used to guide one or more tools to an area of interest in a medical procedure.
In one aspect, the present disclosure provides a method for creating a template using a robotic assembly of a template system. The template system including a template holder configured to receive the template, a guide coupling aperture, and a controller in communication with an imaging system. The method includes arranging the template holder adjacent to a region of interest of a patient such that the template holder restricts access to the region of interest of the patient, acquiring one or more images of the template holder and the region of interest of the patient with the imaging system, and determining, using the one or more images, an geometric location of the region of interest. The method further includes engaging the template with the robotic assembly of the robotic-guided assembly system, robotically guiding the guide coupling aperture to a location on the template corresponding to the geometric location of the region of interest, and creating a hole in the template at the location on the template corresponding to the geometric location of the region of interest.
In another aspect, the present disclosure provides a method of performing an image guide medical procedure on a patient within an imaging system. The method includes placing a template holder adjacent to a region of interest of the patient such that the template holder restricts access to the region of interest of the patient, and robotically creating a template. The template is robotically created by capturing one or more images of the template holder and the region of interest of the patient with the imaging system, identifying, using the one or more images, an area of tissue within the region of interest of the patient, engaging the template with a robotic assembly of a robotic-guided assembly system, robotically guiding a guide coupling aperture of the robotic assembly to a location on the template corresponding to the geometric location of the identified area of tissue, and creating a hole in the template at the location on the template corresponding to the geometric location of the identified area of tissue. The method further includes upon creating the hole in the template, disengaging the template from the robotic assembly and engaging the template with the template holder, inserting a needle through the hole in the template and into the patient, verifying a position of the needle within the patient via the imaging system, performing a treatment on the identified area of tissue within the patient, and removing the needle from the patient.
In yet another aspect, the present disclosure provides a method for automated guidance of an image-guided medical procedure. The method includes accessing one or more images of a region of interest of a patient and a template holder arranged adjacent to the region of interest of the patient such that the template holder restricts access to the region of interest of the patient from at least one direction, and using the one or more images of the region of interest and template holder, identifying desired tissue in the region of interest and a geometric location relative to the template holder that provides access to the desired tissue through the template holder from the at least one direction. The method further includes communicating the geometric location to a controller configured to create a hole in a template configured to be coupled with the template holder to provide access to the desired tissue from the at least one direction through the template when the template is engaged with the template holder, accessing one or more images of a needle being inserted through the hole in the template from the at least one direction and into the patient toward the desired tissue, and verifying a position of the needle within the patient using the one or more images of the needle being inserted.
In still another aspect, the present disclosure provides a template system for an image guided medical procedure performed on a patient. The template system includes a first motor, a second motor and a robotic assembly. The robotic assembly includes a robotic assembly frame including a first guide and a second guide. The first guide is moveable along a first axis and operably coupled to the first motor, and the second guide is moveable along a second axis substantially perpendicular to the first axis and operably coupled to the first motor. The robotic assembly further includes a hole guide coupling to couple the first guide to the second guide and having a guide coupling aperture. The template system further includes a template configured to be received within the robotic assembly frame, and a controller configured to control the first motor and the second motor to move the first guide and the second guide and thereby position the guide coupling aperture in one or more pre-determined locations.
In yet another aspect, the present disclosure provides a disposable template for a guided medical procedure. The template configured to be removably received within a template holder. The template includes a first side and a second side each coated with a removable thin film. The template is fabricated from a non-ferrous material.
The foregoing and other aspects and advantages of the invention will appear from the following description. In the description, reference is made to the accompanying drawings which form a part hereof, and in which there is shown by way of illustration a preferred embodiment of the invention. Such embodiment does not necessarily represent the full scope of the invention, however, and reference is made therefore to the claims and herein for interpreting the scope of the invention.
The invention will be better understood and features, aspects and advantages other than those set forth above will become apparent when consideration is given to the following detailed description thereof. Such detailed description makes reference to the following drawings.
Robotic devices have been introduced to overcome some of the access challenges for magnetic resonance imaging (MRI)-guided procedures, and to improve tool placement accuracy with a goal of better diagnostic and therapeutic outcome. However, these current robotic devices are costly because they must be fabricated from a MRI compatible material. That is, current robotic devices are required to be placed within the limited spaced of an MR bore and, therefore, the entirety of the robotic device must be fabricated from a costly non-ferrous material. Additionally, current robotic devices are typically limited to holding one needle which limits the robotic device to only make multiple needle insertions one at a time (i.e., not simultaneously).
Due to the current deficiencies in robotic MRI-guided procedures, it would be desirable to have a template system for MRI-guided medical procedures having a disposable template for accurately locating a target area. The disposable template can improve targeting accuracy, acquisition of harmful tissue, and reduce procedure time as related to the manual procedures. Further, only the disposable template is required to be fabricated from an MRI compatible material which significantly reduces a cost of the template system when compared to current robotic devices.
The first driver 16 is connected to a first motor 22. The first motor 22 is coupled to a robotic assembly 24 and configured to provide motion of the robotic assembly 24 in along a first axis in response to a signal from the first driver 16. A first limit switch 26 is operably coupled to the first motor 22 and in communication with the controller 14. The first limit switch 35 is configured to prevent the first motor 22 from moving the robotic assembly 24 along the first axis beyond a pre-defined limit. A first encoder 28 is in communication with the controller 14 and configured to send positional feedback signals to the controller 14. That is, the first encoder 28 is configured to communicate a position of the robotic assembly 24 along the first axis to the controller 14.
The second driver 18 is connected to a second motor 30. The second motor 30 is coupled to the robotic assembly 24 and configured to provide motion of the robotic assembly 24 along a second axis perpendicular to the first axis in response to a signal from the second driver 18. A second limit switch 32 is operably coupled to the second motor 30 and in communication with the controller 14. The second limit switch 32 is configured to prevent the second motor 30 from moving the robotic assembly 24 along the second axis beyond a pre-defined limit. A second encoder 34 is in communication with the controller 14 and configured to send positional feedback signals to the controller 14. That is, the second encoder 34 is configured to communicate a position of the robotic assembly 24 along the second axis to the controller 14.
The third driver 20 is connected to a third motor 36. The third motor 36 is coupled to the robotic assembly 24 and configured to provide motion of the robotic assembly 24 along a third axis perpendicular to the first axis and the second axis in response to a signal from the third driver 20. A third limit switch 38 is operably coupled to the third motor 36 and in communication with the controller 14. The third limit switch 38 is configured to prevent the third motor 36 from moving the robotic assembly 24 along the third axis beyond a pre-defined limit. A third encoder 40 is in communication with the controller 14 and configured to send positional feedback signals to the controller 14. That is, the third encoder 40 is configured to communicate a position of the robotic assembly 24 along the second axis to the controller 14. A fourth motor 42 is connected to the controller 14 and coupled to the robotic assembly 24. The fourth motor is configured to provide rotational motion of the robotic assembly 24.
The robotic assembly 24 includes a base 44 and a robotic assembly frame 46 coupled to the base 44. The base 44 includes an assembly platform 48 that extends substantially perpendicularly from a vertical wall 50. The robotic assembly frame 46 is mounted on the assembly platform 48 of the base 44. The vertical wall 50 includes a plurality of apertures 52 and a pair of opposing horizontal walls 54. The plurality of apertures 52 extend through the vertical wall 50. The pair of opposing horizontal walls 54 extend substantially perpendicularly from the vertical wall 50 in an opposite direction as the assembly platform 48. The pair of opposing horizontal walls 54 and the vertical wall 50 define a cavity where, in one non-limiting example, the first motor 22 and the second motor 30 can be mounted.
The illustrated robotic assembly frame 46 defines a substantially rectangular shape. In other non-limiting examples, the robotic assembly frame 46 may define an alternative shape, as desired. The robotic assembly frame 46 includes a first frame slot 56, a second frame slot 58, a third frame slot 60, and a fourth frame slot 62. The first frame slot 56 slidably receives a one end of a first guide 64 and the second frame slot 58 slidably receives the other end of the first guide 64. The third frame slot 60 slidably receives one end of a second guide 66 and the fourth frame slot 62 slidably receives the other end of the second guide 66. The first guide 64 and the second guide 66 are configured to be arranged substantially perpendicularly to each other and moveable in perpendicular directions with respect to each other. That is, the first hole perforator guide 64 is configured to be movable along the first frame slot 56 and the second frame slot 58 in a direction parallel to the first axis in response to movement of the first motor 22. Similarly, the second guide 66 is configured to be moveable along the third frame slot 60 and the fourth frame slot 62 in a direction parallel to the second axis in response to movement of the second motor 30.
With continues reference to
The hole guide coupling 72 is configured to receive a hole perforating assembly 74. The hole perforating assembly 74 includes a hole punch 76 and a handle 78. The illustrated hole perforating assembly 74 enables a user of the template system 10 to manually drill, or punch, a hole in the template 43 in a pre-determined location on the template 43. It should be known that the hole perforating assembly 74 may be configured to produce a hole in the template 43 using another mechanism known in the art, for example, laser machining or water jets. In other non-limiting examples, the hole perforating assembly 74 can be coupled to the third motor 36 and the fourth motor 42 to automate the drilling process with the hole perforating assembly 74.
The robotic assembly frame 46 includes a first frame template slot 77 arranged below the third frame slot 60 and a second frame template slot 79 arranged below the fourth frame slot 62. The first guide 64 includes a first guide template slot 80. The first frame template slot 77, the second frame template slot 79, and the first guide template slot 80 are horizontally aligned and are each configured to slidably receive the template 43. That is, when a user of the template system 10 desires to perforate the template 43 in one or more pre-determined locations, the user can insert the template 43 through the first frame template slot 78 and thereby through first guide template slot 80 towards the second frame template slot 79.
Turning to
The first guide displacement assembly 80 includes a drive shaft 86, driving gears 88, a first gear set 90, a second gear set 92, a first shaft 94, and a second shaft 96. The first motor 22 is configured to be coupled to the driving gears 88 to rotate the drive shaft 86 in a desired direction. The first gear set 90 is coupled to a first end of the drive shaft 86 and the first shaft 94. The second gear set 92 is coupled to an opposing second end of the drive shaft 86 and the second shaft 96. The first shaft 94 and the second shaft 96 are arranged substantially perpendicularly to the drive shaft 86. The first shaft 94 and the second shaft 96 are each received in a respective coupling aperture 97 of the first guide 64 which couples the first shaft 94 and the second shaft 96 to the first guide 64. The coupling apertures 97 of the first guide 64 are arranged on opposing ends of the first guide 64. In one non-limiting example, the first shaft 94 and the second shaft include external threads.
The second guide displacement assembly 82 includes a drive shaft 98, driving gears 100, a first gear set 102, a second gear set 104, a first shaft 106, and a second shaft 108. The second motor 30 is configured to be coupled to the driving gears 100 to rotate the drive shaft 98 in a desired direction. The first gear set 102 is coupled to a first end of the drive shaft 98 and the first shaft 106. The second gear set 104 is coupled to an opposing second end of the drive shaft 98 and the second shaft 108. The first shaft 106 and the second shaft 108 are arranged substantially perpendicularly to the drive shaft 98. The first shaft 106 and the second shaft 108 are each received in a respective coupling aperture 109 of the second guide 66 which couples the first shaft 106 and the second shaft 108 to the second guide 66. The coupling apertures 109 of the second guide 66 are arranged on opposing ends of the second guide 66. In one non-limiting example, the first shaft 106 and the second shaft 108 include external threads.
In operation, the first motor 22 is configured to rotate the drive shaft 86 in a desired direction. The rotation of the drive shaft 86 in the desired direction results in rotation of the first shaft 94 and the second shaft 96 in desired directions which is converted into movement of the first guide 64 along the first frame slot 56 and the second frame slot 58. As described above, the first frame slot 56 and the second frame slot 58 restrict the first guide 64 to movement along the first axis. The second motor 30 is configured to rotate the drive shaft 98 in a desired direction. The rotation of the drive shaft 98 in the desired direction results in rotation of the first shaft 106 and the second shaft 108 in desired directions which is converted into movement of the second guide 66 along the third frame slot 60 and the fourth frame slot 62. As described above, the third frame slot 60 and the fourth frame slot 62 restrict the second guide 66 to movement along the second axis. As described above, movement of the first guide 64 and/or the second guide 66 results in the hole guide coupling 72 to move along either the first guide slot 68 and/or the second guide slot 70. In this way, the robotic assembly 24 enables the template system 10 to robotically position the guide coupling 72 in a desired position (i.e., X,Y coordinate location) within the robotic assembly frame 46.
With continued reference to
The illustrated template 43 defines a substantially rectangular shape. In other non-limiting examples, the template 43 may define an alternative shape, such as an elliptical shape, a round shape, a square shape, or a polygonal shape, as desired. The template 43 is fabricated from a material that will not interfere with an MRI imaging process. For example, the template 43 can be fabricated from a non-ferrous metal or a plastic material. In most non-limiting examples, the template is sterilized and includes a thin film covering both sides of the template 43 to preserve the sterilized nature of the template 43. It should be known that the illustrated template 43 is shown with a plurality of pre-drilled holes, however, this is merely for illustrative purposes and, in operation, the template 43 would be provided without any pre-drilled holes.
Turning to
Once the one or more holes in pre-determined locations have been drilled, or punched, into the template 43, the thin film can be removed from the template 43, and the template 43 can be placed in a template holder 124, as shown in
As shown in
The pulse sequence server 144 functions in response to instructions downloaded from the operator workstation 136 to operate a gradient system 154 and a radiofrequency (“RF”) system 156. Gradient waveforms necessary to perform the prescribed scan are produced and applied to the gradient system 154, which excites gradient coils in an assembly 158 to produce the magnetic field gradients Gx, Gy, and Gz used for position encoding magnetic resonance signals. The gradient coil assembly 158 forms part of a magnet assembly 160 that includes a polarizing magnet 162 and a whole-body RF coil 164 or local RF coil.
In operation, RF waveforms are applied by the RF system 156 to the RF coil 164, or a separate local coil, in order to perform the prescribed magnetic resonance pulse sequence. Responsive magnetic resonance signals detected by the RF coil 164, or a separate local coil, are received by the RF system 156, where they are amplified, demodulated, filtered, and digitized under direction of commands produced by the pulse sequence server 144. The RF system 156 includes an RF transmitter for producing a wide variety of RF pulses used in MRI pulse sequences. The RF transmitter is responsive to the scan prescription and direction from the pulse sequence server 144 to produce RF pulses of the desired frequency, phase, and pulse amplitude waveform. The generated RF pulses may be applied to the whole-body RF coil 164 or to one or more local coils or coil arrays (not shown in
The RF system 156 also includes one or more RF receiver channels. Each RF receiver channel includes an RF preamplifier that amplifies the magnetic resonance signal received by the coil 130 to which it is connected, and a detector that detects and digitizes the I and Q quadrature components of the received magnetic resonance signal. The magnitude of the received magnetic resonance signal may, therefore, be determined at any sampled point by the square root of the sum of the squares of the I and Q components:
M=√{square root over (I2+Q2)} (1);
and the phase of the received magnetic resonance signal may also be determined according to the following relationship:
The pulse sequence server 144 also optionally receives patient data from a physiological acquisition controller 166. By way of example, the physiological acquisition controller 166 may receive signals from a number of different sensors connected to the patient, such as electrocardiograph (“ECG”) signals from electrodes, or respiratory signals from a respiratory bellows or other respiratory monitoring device. Such signals are typically used by the pulse sequence server 144 to synchronize, or “gate,” the performance of the scan with the subject's heart beat or respiration.
The pulse sequence server 144 also connects to a scan room interface circuit 168 that receives signals from various sensors associated with the condition of the patient and the magnet system. It is also through the scan room interface circuit 168 that a patient positioning system 170 receives commands to move the patient to desired positions during the scan.
The digitized magnetic resonance signal samples produced by the RF system 156 are received by the data acquisition server 146. The data acquisition server 146 operates in response to instructions downloaded from the operator workstation 136 to receive the real-time magnetic resonance data and provide buffer storage, such that no data is lost by data overrun. In some scans, the data acquisition server 146 does little more than pass the acquired magnetic resonance data to the data processor server 114. However, in scans that require information derived from acquired magnetic resonance data to control the further performance of the scan, the data acquisition server 146 is programmed to produce such information and convey it to the pulse sequence server 144. For example, during prescans, magnetic resonance data is acquired and used to calibrate the pulse sequence performed by the pulse sequence server 144. As another example, navigator signals may be acquired and used to adjust the operating parameters of the RF system 156 or the gradient system 154, or to control the view order in which k-space is sampled. In still another example, the data acquisition server 146 may also be employed to process magnetic resonance signals used to detect the arrival of a contrast agent in a magnetic resonance angiography (“MRA”) scan. By way of example, the data acquisition server 146 acquires magnetic resonance data and processes it in real-time to produce information that is used to control the scan.
The data processing server 148 receives magnetic resonance data from the data acquisition server 146 and processes it in accordance with instructions downloaded from the operator workstation 136. Such processing may, for example, include one or more of the following: reconstructing two-dimensional or three-dimensional images by performing a Fourier transformation of raw k-space data; performing other image reconstruction algorithms, such as iterative or backprojection reconstruction algorithms; applying filters to raw k-space data or to reconstructed images; generating functional magnetic resonance images; calculating motion or flow images; and so on.
Images reconstructed by the data processing server 148 are conveyed back to the operator workstation 136 where they are stored. Real-time images are stored in a data base memory cache (not shown in
The MRI system 134 may also include one or more networked workstations 176. By way of example, a networked workstation 176 may include a display 178; one or more input devices 180, such as a keyboard and mouse; and a processor 182. The networked workstation 176 may be located within the same facility as the operator workstation 136, or in a different facility, such as a different healthcare institution or clinic.
The networked workstation 176, whether within the same facility or in a different facility as the operator workstation 136, may gain remote access to the data processing server 148 or data store server 150 via the communication system 152. Accordingly, multiple networked workstations 142 may have access to the data processing server 148 and the data store server 150. In this manner, magnetic resonance data, reconstructed images, or other data may be exchanged between the data processing server 148 or the data store server 150 and the networked workstations 142, such that the data or images may be remotely processed by a networked workstation 176. This data may be exchanged in any suitable format, such as in accordance with the transmission control protocol (“TCP”), the internet protocol (“IP”), or other known or suitable protocols.
In one non-limiting example, the external controller 12 of the template system 10 may be the processor 142 of the operator workstation 136. In another non-limiting example, the external controller 12 of the template system 10 may be the processor 182 of the network workstation 176. In either case, the external controller 12 is configured to relay information to the controller 14 based on the images taken by the MRI system 134, as will be described below.
Turning to
One non-limiting example of the operation of the template system 10 will be described below with reference to
The user, or trained medical professional, then determines at step 212 if additional targets remain in the images obtained at step 204. If additional target areas are identified, the user, or trained medical professional can revert back to step 208 and mark these additional target areas. If no more suspicious areas are identified, the controller 14 can be initialized to start a zeroing procedure at step 214. During the zeroing procedure at step 214, the controller 14 instructs the first driver 16 and the second driver 18 to move the first motor 22 and the second motor 30 to a known zeroed X,Y location. Following the zeroing procedure at step 214, the controller 14 is configured robotically instruct at step 216, via the first driver 16 and the second driver 18, the first motor 22 and the second motor 30 to move the first guide 64 and the second guide 66 such that the guide coupling aperture 114 of the hole guide coupling 72 is in the X,Y coordinates on the template 43 that correspond with the target location(s) marked at step 208. Once the guide coupling aperture 114 of the hole guide coupling 72 is positioned in the correct X,Y coordinate position, a hole can be drilled, or punched, into the template 43 using the hole perforating assembly 74 at step 218. Once the hole is punched in the template 43 at step 218, the controller 14 determines is additional target locations remain. If additional target locations remain, the controller 14 instructs the first motor 22 and the second motor 30 to move to the X,Y coordinates on the template 43 of the next target location at step 216, as described above. If all the target locations have been punched in the template 43, then the thin film can be removed from the template 43 and the template 43 is removed from the robotic assembly 24 and placed in the template holder 124 at step 222 thereby ending the pre-procedure at step 224. It should be known that although the above described pre-procedure of
Once the pre-procedure process of
As shown in
As described above, the present disclosure provides a template system 10 which can be used to robotically locate areas of interest within a patient to more accurately perform an image guided medical procedure. This can enable non discrete guidance to the identified locations for higher accuracy and result is less failed procedures.
Thus, while the invention has been described above in connection with particular embodiments and examples, the invention is not necessarily so limited, and that numerous other embodiments, examples, uses, modifications and departures from the embodiments, examples and uses are intended to be encompassed by the claims attached hereto. The entire disclosure of each patent and publication cited herein is incorporated by reference, as if each such patent or publication were individually incorporated by reference herein.
This application is based on, claims priority to, and incorporates herein by reference in its entirety, each of U.S. Provisional Application Ser. No. 62/211,035, filed Aug. 28, 2015, and entitled and entitled “NEEDLE PLACEMENT GUIDANCE TEMPLATES,” and U.S. Provisional Application Ser. No. 62/276,152, filed Jan. 7, 2016, and entitled “SYSTEMS AND METHODS FOR A TEMPLATE SYSTEM USED IN IMAGE GUIDED MEDICAL PROCEDURES.”
This invention was made with government support under grant no. P41EB015898/EB awarded by the National Institutes of Health. The government has certain rights in the invention.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US16/48897 | 8/26/2016 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62211035 | Aug 2015 | US | |
| 62276152 | Jan 2016 | US |
