Systems exist for the robotic feeding of percutaneous interventional devices such as guide wires and working catheters into guide catheters and procedures exist for the placement and seating of guide catheters such that their distal ends are adjacent the site of action for the intervention, typically a valve or chamber of the heart or a lesion in a blood vessel such as an artery. The guide catheter is typically placed by manual manipulation of medical personnel and its continued seating after placement assumed or determined by feel. The interventional devices such as guide wires and working catheters may be fed by the operation of robotic controls by medical personnel such as shown in U.S. Pat. No. 7,887,549.
The present invention involves the use of X-ray markers that appear in fluoroscopic images and are detected by image processing software to partially or fully automate or assist in the performance of one or more of the steps of a percutaneous interventional procedure typically involving a guide catheter.
The present invention also involves a process for mapping the three dimensional configuration of a blood vessel of a human subject by providing an elongated percutaneous device, a system for measuring advancement and retraction of the elongated percutaneous device and a fluoroscopic imaging system which provides a two dimensional image of a portion of the elongated percutaneous device in the blood vessel. A first fluoroscopic image is obtained when the portion of the elongated percutaneous device is at a first location within the blood vessel and a second fluoroscopic image is obtained when the portion of the elongated percutaneous device is at a second location within the blood vessel. A measurement is made of a first distance that the elongated percutaneous device has advanced or retracted when the first fluoroscopic image is taken and a measurement is made of a second distance that the elongated percutaneous device has advanced or retracted between the first fluoroscopic image and the second fluoroscopic image. The fluoroscopic images are correlated with the distance measurements to provide an indication of the travel of the elongated percutaneous device out of the plane of the fluoroscopic image.
The present invention further involves a process to optimize the plane of a fluoroscopic image used to monitor a percutaneous interventional procedure on a human subject involving a blood vessel by providing an elongated percutaneous device, a system for measuring advancement and retraction of the elongated percutaneous device and a fluoroscopic imaging system which provides a two dimensional image of a portion of the elongated percutaneous device in the blood vessel. The elongated percutaneous device is advanced into or retracted out of the blood vessel and a first fluoroscopic image is obtained when the portion of the elongated percutaneous device is at a first location within the blood vessel and a second fluoroscopic image is obtained when the portion of the elongated percutaneous device is at a second location within the blood vessel. A first distance that the elongated percutaneous device has advanced or retracted is measured when the first fluoroscopic image is taken and a second distance that the elongated percutaneous device has advanced or retracted between the first fluoroscopic image and the second fluoroscopic image is measured. The fluoroscopic images are correlated with the length measurements to provide an indication of the travel of the elongated percutaneous device out of the plane of the fluoroscopic image and the plane of the fluoroscopic image is adjusted to minimize the amount of travel of the elongated percutaneous device out of the plane of the fluoroscopic image.
The present invention additionally involves apparatus for mapping the three dimensional configuration of a blood vessel of a human subject which comprises a guide catheter configured to have its distal end positioned at the ostium of a blood vessel, a fluoroscopic imaging system which provides a two dimensional image of the blood vessel, a robotically driven guide wire carrying an X-ray marker, a measuring mechanism which reports the distance the guide wire has been advanced into the guide catheter, and a control mechanism which captures fluoroscopic images of the X-ray marker of the guide wire when the X-ray marker is at various distances from the distal end of the guide catheter and correlates them to the distances that the guide wire has been advanced into the guide catheter.
This application will become more fully understood from the following detailed description, taken in conjunction with the accompanying figures, wherein like reference numerals refer to like elements in which:
An embodiment involves mapping the path to be followed in deploying a percutaneous intervention device at its site of action. One approach involves deploying a guide catheter in the conventional manner, i.e. manually, and then feeding a guide wire through the guide catheter and measuring its apparent travel path in two-dimensional fluoroscopic images. This may be combined with measurements about the length of guide wire fed into the guide catheter and a general map of the artery system in which the guide catheter is deployed to render a three dimensional map of the path which includes travel in the z direction relative to the two dimensional fluoroscopic images.
A three dimensional relative height map of the artery system is built iteratively by comparing the length of the guide wire fed into the catheter guide to the measurement of the 2D motion of the distal end of the guide wire in the fluoroscopic image between two successive positions. The map can be sampled at a given incremental fixed length of guide wire by acquiring a fluoroscopic image every time a fixed length of wire is inserted and measuring the 2D motion of the wire along the path of the artery. Alternatively a fluoroscopic image can be acquired at regular time interval and a measurement of the length of the wire inserted and the 2D motion the wire along the path of the artery acquired. The measurement of the length of wire fed into the guide catheter and the measured path of the wire along the artery produce a relative height measurement between the initial and final position of the wire by using simple foreshortening geometry. This method only determines the magnitude of the differential height. The polarity of the displacement (up or down) must be inferred by anatomical observation of the arteries or by acquiring a second orthogonal fluoroscopic with a two plane system,
The measurement of the 2D motion of the wire in the artery can be facilitated by insertion of an easily detected fluoroscopic marker on the guide wire. The marker position can be easily be detecting by image processing of the fluoroscopic image.
An embodiment involves providing additional markers to determine the height at multiple positions along the guide wire or working catheter being fed into a guide catheter. The additional markers may be on the guide wire or working catheter being fed or both. Multiple, concurrent height measurements can be achieved along the guide wire or working catheter by simultaneously detecting all the makers and measuring their 2D motion individually. The marker positions can be easily be detecting by image processing of the fluoroscopic image or a plurality of fluoroscopic images.
One of the markers may be inserted at the tip of the wire.
The height map can be updated iteratively every time a guide wire is inserted or any other wire containing marker is inserted into the guide catheter. By changing the sampling time of the fluoroscopic images or the length or rate of insertion of the wire into the catheter guide, the measurement of the height will occur at different locations along the arteries and will fill up the height map.
The accuracy of the height map can be improved by estimating the 2D location of the markers more accurately. The successive 2D fluoroscopic images can be registered to each other by estimating the global 2D motion of each image with respect to a reference image. The estimation of the overall motion is represented by a unique 2D translation vector. The estimation of the overall motion is additionally represented by a unique 2D rotation angle. Once the 2D images are globally aligned, a secondary local alignment close to the marker can be performed for additional accuracy. The global and local alignment can be performed by normalized correlation of the current image and reference image or images or two other images to be aligned. The global and local alignment can be performed using the generalized Hough transform of the current image and reference image or images to be aligned.
An embodiment involves robotically advancing a guide wire or working catheter (i.e. a catheter that carries a balloon, a stent or both) through a guide catheter until it is close to the end of the guide catheter adjacent to the site of action such as a blood vessel lesion or a chamber or valve of the heart. The tip of the guide wire or the distal end of the working catheter and the distal end of the guide catheter may both be provided with a marker visible in a fluoroscopic image.
An embodiment involves providing additional markers, possibly distinctive, to better monitor the progress of the guide wire or working catheter in the guide catheter. The additional markers may be on the guide catheter or the guide wire or working catheter being fed or both. Fluoroscopic images in which these markers appear may be combined with information about the length of guide wire or working catheter fed into the guide catheter to estimate the position of the tip of the guide wire or the end of the working catheter. The multiple markers on the guide catheter may also be used to estimate the effective velocity of the guide wire or working catheter as it is being fed through the guide catheter and this effective velocity may take account of the travel out of the plane of the fluoroscopic images.
The control mechanism of the drive feeding the guide wire or working catheter into the guide catheter causes the feeding to substantially slow or stop as the two markers approach each other. One approach involves taking fluoroscopic images of the progress of the guide wire or working catheter through the guide catheter and using image processing software to estimate the distance between the two markers. The feeding can then be slowed or stopped when the distance falls below a preset value. The X-ray exposure of the patient may be reduced by taking intermittent fluoroscopic images and the frame rate may be selected in accordance with the velocity of feeding of the guide wire or working catheter.
When multiple markers are used on either the guide wire or working catheter and the guide catheter, redundant detection of set of markers decreases the risk of overshooting the end of the guide catheter by imposing a stop if a maker or a set of marker preceding the last distal marker are not detected within a predefined length of guide wire or working catheter.
The use of multiple markers increase the accuracy of the velocity estimation by averaging multiple measurements individually affected by variable foreshortening due to the out of fluoroscopic plane wire incursion.
Additionally, accuracy of the velocity and tip position is increase by the use of a precomputed 3D map of the arteries that take into account foreshortening.
An embodiment involves providing proximal markers for greater safety. One approach is to provide additional markers on the guide catheter spaced proximally from its distal end and using these markers to better assure the control of the emergence of the guide wire or working catheter out of the distal end of the guide catheter.
An embodiment involves determining whether the distal end of a guide catheter has become unseated after it was placed adjacent to the site of action, such as an arterial lesion or a chamber or valve of the heart, and taking corrective action to reseat it. In some cases when a working catheter carrying a stent, a balloon or both passes through a guide catheter toward its distal end seated near the site of action, it causes the guide catheter to move in the opposite direction causing the distal end to unseat. The corrective action may involve applying pressure to the guide catheter in the distal direction to cause it to reseat.
An embodiment involves monitoring the arterial pressure or the ST wave or an electrocardiogram of the patient undergoing the interventional procedure or observing the appearance of a cloud of contrast agent. A change in one of the first two parameters may be used as an indication that the guide catheter is becoming unseated. The appearance of the third may also be used as an indication that distal end of the guide catheter is not in its proper position when contrast agent is being fed through the guide catheter.
The contrast agent may be detected by means of image processing of the fluoroscopic images.
An embodiment involves comparing two registered fluoroscopic images by subtracting from each other and thresholding the resulting subtracted image and computing the size of the thresholded area. The two registered images are comprised of a reference image and the current image or the two registered images are comprised of two successive images.
An embodiment involves stabilizing an angioplasty or stent deployment balloon in its proper position for activation using a robotic feed mechanism. This may involve advancing or retracting the working catheter that is deploying the balloon. The positioning may be monitored by the examination of fluoroscopic images with image processing software and the software may then signal the needed amount of adjustment. For instance, if the balloon, with or without stent, is being deployed over a lesion, image processing software may monitor fluoroscopic images in which markers at both ends of the balloon and the lesion appear and signal the appropriate amount of advancement or retraction to assure that the balloon is in its proper position for inflation.
The system may use a pre-computed 3D height map to correct for foreshortening and compute the foreshortened adjusted length of catheter that needs to be fed. The adjusted length of catheter is provided to the robotic system to advance the catheter by that amount.
The system may measure the length of the balloon in the 2D fluoroscopic image and in infer the local 3D height at that location by comparing the 2D length of the balloon to the known length of the balloon using simple foreshortening trigonometry. The height information is then to compute the foreshortened adjusted length of catheter that needs to be fed. The adjusted length of catheter is provided to the robotic system to advance the catheter by that amount.
An embodiment involves utilizing the guide catheter as an ultrasonic conduit to determine its position. The boundary conditions at the distal end of the conduit may be used to determine whether it is properly seated.
An embodiment involves using multiple images of different areas involved in a percutaneous interventional procedure. It may be advantageous to use multiple fields of view and to tailor the frequency of X-ray imaging to the particular field of view. For instance, one field of view may involve all or most of the path of percutaneous devices such as guide catheters, guide wires and/or working catheters and another to involve the immediate area of the site of action. It may be that more frequent imaging is appropriate for the latter field of view. The differential sampling rates may allow for reducing the overall X-ray exposure of the patient.
The position of the area of interest at the distal end of the catheter may be updated by using an estimation of the velocity of the catheter or guide write feed through the catheter guide to position the window prior to the next fluoroscopic acquisition. The velocity of the device being fed through the guide catheter may be estimated using X-ray markers as discussed above.
An embodiment involves adjustment of the plane of fluoroscopic images of the guide wire or working catheter as it advances through and out of the guide catheter. It may be advantageous to adjust the plane of the images to maximize the portion of the travel of the device that is in the plane of the fluoroscopic image. This may involve a comparison of the apparent travel path in two-dimensional fluoroscopic images with the length of the guide wire or working catheter that has been fed into the guide catheter.
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While the foregoing written description of the invention enables one of ordinary skill to make and use what is considered presently to be the best mode thereof, those of ordinary skill will understand and appreciate the existence of variations, combinations, and equivalents of the specific embodiment, method, and examples herein. The invention should therefore not be limited by the above described embodiment, method, and examples, but by all embodiments and methods within the scope and spirit of the invention as claimed.
This application claims priority to U.S. Provisional Application No. 61/839,459 entitled Robotic Image Control System filed on Jun. 26, 2013 which is incorporated herein by reference in its entirety.
Number | Date | Country | |
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61839459 | Jun 2013 | US |