Locating and analyzing perforator flaps for plastic and reconstructive surgery

Abstract

A method and an apparatus for preoperative identification of a perforator vessel for plastic and/or reconstructive surgery using ICG fluorescence angiography imaging are disclosed. Time-resolved image processing is used to highlight perforator locations and to enable visual discrimination among candidate perforators by various computed metrics. Based on these metrics, the surgeon is able to interactively locate and select perforator vessels suitable for plastic and reconstructive surgery.

Claims

1. A method for evaluating tissue perfusion in a tissue of a subject, the method comprising: detecting, through a skin surface, a fluorescence response from the tissue arising from a bolus of ICG having been administered into the bloodstream of the subject; acquiring a temporal sequence of images of the fluorescence response over a period of time; independently processing each pixel in the temporal sequence of images of the tissue to (i) compute a temporally-based value for each pixel, wherein each temporally-based value is based on a plurality of images of the temporal sequence of images, and (ii) generate a spatial map of the computed temporally-based values; and displaying the spatial map of the computed temporally-based values, wherein each temporally-based value is a peak value of the fluorescence response for the respective pixel.

2. The method of claim 1, further comprising applying a contrast transfer function to the fluorescence response.

3. The method of claim 2, wherein the contrast transfer function represents a linear or nonlinear function which transforms the fluorescence response into an overlay image representing different perfusion characteristics in different colors.

4. The method of claim 3, further comprising displaying in the overlay image a zero (0) marker representative of a background fluorescence response of (a) substantially unperfused tissue, (b) background noise, or (c) residual ICG and a hundred (100) marker representative of a fluorescence response of well perfused tissue.

5. The method of claim 4, wherein the zero marker is associated with a non-fluorescent object placed on the substantially unperfused tissue.

6. The method of claim 4, wherein the zero marker is derived from a fluorescence response from tissue prior to arrival of the ICG bolus in the tissue.

7. The method of claim 4, further comprising displaying numerical values of the fluorescence response in the overlay image.

8. The method of claim 4, further comprising: normalizing the numerical values of the fluorescence response to a range between the zero marker and the hundred marker, and displaying normalized numerical values of the fluorescence response in the overlay image.

9. The method of claim 8, wherein the normalized numerical values of the fluorescence response are computed for different image regions of an anatomical feature.

10. The method of claim 9, wherein the normalized numerical values of the fluorescence response are computed with the following steps: computing the fluorescence response for all pixels, averaging the fluorescence response over a predefined region in the image, normalizing the averaged fluorescence response in the entire image, and scaling the normalized averaged fluorescence response of the contrast transfer function.

11. The method of claim 2, wherein the contrast transfer function is a non-linear function with regions of different slope, and wherein the different slopes and transition between the different slopes are adjusted during a procedure to evaluate the perfusion of the tissue.

12. The method of claim 1, further comprising: identifying a first reference label associated with native tissue apart from the tissue being evaluated; identifying a second reference label associated with fluorescence response of the tissue being evaluated that achieves a predetermined perfusion; normalizing at least one additional label associated with fluorescence response of pixel values for a second region of the tissue being evaluated to the range established by the first and second reference labels; and displaying the first reference label, the second reference label, and the at least one additional label on a color or black-and-white image.

13. The method of claim 12, wherein the first reference label, the second reference label, and the one additional label are each numerical values.

14. The method of claim 1, further comprising: selecting a zone from the tissue being evaluated for use in a subsequent surgical step based on the spatial map of the computed temporally-based values.

15. The method of claim 1, further comprising: determining a zone from the tissue being evaluated for use in reconstructive surgery based on perforator vessels in the tissue being evaluated represented in the spatial map of the computed temporally-based values.

16. The method of claim 1, further comprising: selecting, in the temporal sequence of images or in the spatial map, a target region, a first reference region representing a well-perfused tissue, and a second reference region representing background, and processing the target region using the first reference region and the second reference region to compute a quantitative representation of tissue perfusion in the target region.

17. The method of claim 1, further comprising: generating in real time a composite overlay image of the fluorescence response.

18. An apparatus for evaluating perforator vessels in candidate perforator flaps, comprising: means for detecting a fluorescence response from blood-carried ICG in the perforator vessels in the candidate perforator flaps; means for acquiring a temporal sequence of images of the fluorescence response over a predetermined time; means for processing the sequence of images to yield a time-integrated intensity or time-derivative of the intensity for pixel values in the images corresponding to the blood-carried ICG in the perforator vessels in the candidate perforator flaps, said means for processing including an algorithm that inversely weights the pixel values in relation to elapsed time from application of an ICG bolus into the bloodstream until fluorescence; and means for displaying the time-integrated intensity or time-derivative of the intensity as a color or black-and-white image.

19. An apparatus for evaluating tissue perfusion in a tissue of a subject, comprising: a camera configured to detect, through a skin surface, a fluorescence response from the tissue arising from a bolus of ICG having been administered into the bloodstream of the subject; a processor configured to acquire a temporal sequence of images of the fluorescence response over a period of time, and independently process each pixel in the temporal sequence of images of the tissue to (i) compute a temporally-based value for each pixel, wherein each temporally-based value is based on a plurality of images of the temporal sequence of images, and (ii) generate a spatial map of the computed temporally-based values; and a display configured to display the spatial map of the computed temporally-based values, wherein each temporally-based value is a peak value of the fluorescence response for the respective pixel.

20. The apparatus of claim 19, wherein the processor is further configured to select, in the temporal sequence of images or in the spatial map, a target region, a first reference region representing a well-perfused tissue, and a second reference region representing background, and process the target region using the first reference region and the second reference region to compute a quantitative representation of tissue perfusion in the target region.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The following Figures depict certain illustrative embodiments of the invention in which like reference numerals refer to like elements. These depicted embodiments are to be understood as illustrative of the invention and not as limiting in any way.

(2) FIG. 1 shows schematically a camera system for observing ICG fluorescence;

(3) FIG. 2 shows an ICG fluorescence image of an area of skin, with the pixel values integrated over time;

(4) FIG. 3 shows an ICG fluorescence image of an area of skin integrated over time, with the pixel values inversely weighted by elapsed time;

(5) FIG. 4 shows an ICG fluorescence image of an area of skin, with the pixel values determined by the rate of increase of fluorescence;

(6) FIG. 5 shows an ICG fluorescence image of an area of skin, with the pixel values determined by elapsed time to maximum fluorescence; and

(7) FIG. 6 shows an ICG fluorescence image of an area of skin, with the pixel values determined by peak fluorescence;

(8) FIG. 7 shows an overlay of the fluorescence image processed with a variable contrast transfer function;

(9) FIG. 8 shows an overlay of the fluorescence image processed with another variable contrast transfer function;

(10) FIG. 9 shows an overlay of the fluorescence image processed with yet another variable contrast transfer function;

(11) FIG. 10A is a fluorescence image of the perfused region; and

(12) FIG. 10B is a black/white rendition of a colored overlay corresponding to the fluorescence image of FIG. 10A, with markers indicating a normalized intensity.

DETAILED DESCRIPTION

(13) The invention is directed to preoperative determination of the location of perforator vessels in perforator flaps by a non-invasive method, before any incision is made.

(14) FIG. 1 shows schematically a device for a non-invasive, through the skin determination of tissue perfusion in operative, in particular preoperative, applications by ICG fluorescence imaging. An infrared light source, for example, one or more diode lasers or LEDs, with a peak emission of about 780-800 nm for exciting fluorescence in ICG is located inside housing 1. The fluorescence signal is detected by a CCD camera 2 having adequate near-IR sensitivity; such cameras are commercially available from several vendors (Hitachi, Hamamatsu, etc.). The CCD camera 2 may have a viewfinder 8, but the image may also be viewed during the operation on an external monitor which may be part of an electronic image processing and evaluation system 11.

(15) A light beam 3, which may be a divergent or a scanned beam, emerges from the housing 1 to illuminate an area of interest 4, i.e. the area where a flap with suitable perforator vessels is expected to be located. The area of interest may be about 10 cm10 cm, but may vary based on surgical requirements and the available illumination intensity and camera sensitivity.

(16) A filter 6 is typically placed in front of the camera lens 7 to block excitation light from reaching the camera sensor, while allowing fluorescence light to pass through. The filter 6 may be an NIR long-wave pass filter (cut filter), which is only transparent to wavelengths greater than about 815 nm, or preferably a bandpass filter transmitting at peak wavelengths of between 830 and 845 nm and having a full width at half maximum (FWHM) transmission window of between about 10 nm and 25 nm, i.e. outside the excitation wavelength band. The camera 2 may also be designed to acquire a color image of the area of interest to allow real-time correlation between the fluorescence image and the color image.

(17) In the context of the present invention, the device illustrated in FIG. 1 is used to identify/locate perforator vessels prior to surgerythis will assist the surgeon in selecting the best flap or flap zone for use during the reconstruction.

(18) In other post-operative applications, the device can be used to:

(19) Validate anastomotic patency and arterial and venous flowthis can potentially improve outcomes to eliminate flap failure which can be a result of poor arterial flow and inadequate perfusion as well as poor venous return resulting in congestion.

(20) Visualize and confirm complete tissue perfusion, as micro-vascular perfusion to the entire flap and native tissue is critical to flap survival.

(21) With the invention, perforator locations are visualized by image processing and presentation techniques to enable easy and objective visual discrimination among candidate perforators. ICG is injected and the entire ICG fluorescence perfusion and wash-out cycle is captured by the imaging device. After image acquisition, the entire sequence or some temporal sub-range of the images is processed by an image processing algorithm, which may be selected by the surgeon.

(22) Processed results of the fluorescence measurements may be visualized, for example, as false color images or as a contour map, to enable rapid visual evaluation according to the applied algorithm metric. For example, the fluorescence intensity for each pixel may be rendered as a spectral color varying from blue (cool spots or low fluorescence-intensity or rate) to red (hot spots or high fluorescence-intensity or rate). Other spectral associations are easily accommodated. The output may be presented as a semi-transparent overlay on the original anatomical images. This enables visual correlation of hot spots with the underlying anatomy. The meaning of hot spots varies with the algorithm employed, such as integrated intensity, weighted or unweighted, rate of increase or wash-out.

(23) The user is given interactive control over the hot to cool color mapping and can vary it in real time to explore finer or coarser sub-ranges of the dynamic range of each algorithm's output metric. As the color window is widened, the hottest regions are highlighted first, followed by the cooler regions. This kind of adjustment can be made by changing the mapping of luminosity or contrast between the acquired pixels and the pixels in the displayed image. Such mapping functions may be included in standard imaging programs. This windowing process based on the currently employed metric aids in discriminating between perforators and enhances perception and improves understanding by the surgeon of the applied ICG dynamics.

(24) The invention also supports the simultaneous display and evaluation of two sequences from two different locations on the patient's skin. This enables comparison of candidate flaps that are separated by a distance greater than the imaging system's field of view.

(25) FIG. 2 shows an image of an area of a patient's skin where suitable perforator vessels are to be identified. Each pixel represents the time integral of fluorescence intensity over the exposure time for the image sequence. This mode is typically referred to as integration mode in image processing and many image processors offer this mode as a standard feature. In practice, the pixel intensities (collected charges in a CCD) acquired during each frame in the image sequence are added on a pixel-by-pixel basis, for example in the image processor, and divided by the number of frames, whereafter the sum may be normalized to a fixed dynamic range, for example, from 1 to 255 (8-bits). The notion is that brighter pixels in an image represent an area of the skin infused with a greater volume of blood carrying ICG over a preset period of time. In FIG. 2, the perforator vessel 24 exhibits the highest integrated fluorescence intensity, with another perforator vessel exhibiting weaker fluorescence intensity shown as 26.

(26) Note that the transparency of the image has been set such that the physician's marker 22 is visible through the transparent color overlay of the ICG fluorescence image at the upper right of the screen.

(27) FIG. 3 shows an ICG fluorescence image of the same area of skin integrated over time, with the pixel values inversely weighted by elapsed time. This image processing algorithm is similar to the previously described integration, but instead of adding the measured intensities of each pixel directly, the measured intensity values are first divided by the elapsed time after start of the observation of ICG fluorescence, before being added. In this way, earlier fluorescence signals are given a greater significance that fluorescence signals acquired later. The hottest pixels are those pixels that in the sequence of image frames fluoresce earlier than other pixels which the ICG bolus reaches at a later time. The same perforator vessel 34 is identified as in FIG. 2, with another vessel 36 barely identifiable.

(28) FIG. 4 shows an ICG fluorescence image, again of the same area of skin, with the pixel values in this image determined by the rate of increase of fluorescence intensity. In this image processing algorithm, a slope of the pixel intensity versus elapsed time is computed for each pixel in an image. For example, each pixel may have an assigned lowest intensity value (baseline) and an assigned highest intensity value (or another relatively high-intensity value). For each pixel, the time when the pixel intensity crosses the baseline and the time when the pixel intensity crosses the high-intensity value are noted. From this information, the image processing algorithm computes a rate of increase for each pixel in the image, with hotter pixels having a greater slope, i.e., they reach the high-intensity value faster than cooler pixels. This embodiment of the image processing algorithm thus highlights the speed at which the ICG bolus reaches the perforator vessels. The transparency has been turned off in FIG. 4, so that the surgeon's tool is not visible in the image.

(29) The previously identified perforator vessel, shown here with the reference symbol 44, is much better defined, as are the vessel 46 (previously shown as 26 and 36) and another vessel 48.

(30) FIG. 5 shows an ICG fluorescence image of the same area of skin, with the pixel values determined by elapsed time to maximum fluorescence. Unlike FIG. 4, which displays the time rate of change, the image processing algorithm of FIG. 5 displays the time at which pixels reach their maximum intensity, with the hotter pixels reaching their respective peak fluorescence intensity sooner than cooler pixels. The algorithm thus highlights areas of the image in the order in which perforators reach their peak intensity. In this image, the previously identified perforator vessels 24, 34, 44 is again clearly distinguishable, as are the vessels 56 and 58 which correspond to the vessels 46 and 48 of FIG. 4.

(31) FIG. 6 shows an ICG fluorescence image of the same area of skin, with the pixel values determined by the peak fluorescence value at each pixel. Higher (hot) fluorescence intensity values 64 may indicate a higher ICG concentration or may be caused by perforator vessels located closer to the skin surface, which reduces absorption of the excitation light/fluorescence response. The vessels 66, 68 which were clearly visible in FIGS. 4 and 5, are barely distinguishable from the background.

(32) While the images shown, for example, in FIGS. 2 and 6 are rendered with a linear contrast transfer function providing a 1:1 mapping of pixel values processed with the various algorithms described above to the displayed pixel intensities, images can also be rendered (as contour maps or false color overlays) with a variable contrast transfer function to enhance the visual differences in the image. In addition, labels may be placed in the overlay images, hereinafter referred to as ACR (accumulated or time-integrated intensity ratio) labels, which facilitate a quantitative comparison between two or more regions of the anatomy.

(33) Because absolute pixel values in the image change when the dynamic range and slope of the variable contrast transfer function is modified, the ACR labels allow the user to compare the relative perfusion in different image regions as measured by any of the selected overlay techniques (e.g. accumulated/time-averaged intensity, etc.).

(34) The following approach is used to compute the ACR label values. For clarity, we assume that accumulated intensity is selected as overlay technique, although the same approach can be used with any of the available overlay techniques.

(35) 1) The accumulated intensity for all pixels for all images in the image sequence is computed over a time window.

(36) 2) The accumulated intensity is averaged over a region of the selected label (for example, a 55 pixel square matrix).

(37) 3) The averaged intensity is normalized to the maximum value of the accumulated intensity in the entire image.

(38) 4) The normalized averaged is intensity scaled, with the maximum value of the transfer function representing 100%.

(39) By following this approach, the relative ratio of two different ACR labels remains unchanged even though the slope of the transfer function is modified. FIGS. 7 and 8 show a fluorescence image from the image sequence that has been processed with one of the aforementioned algorithms (upper part of the gray-scale image) and the false-color overlay image rendering the accumulated intensity from the sequence in color (from blue for low values to red for high values) for two different contrast functions. The pixel values in FIG. 7 are processed with a first contrast transfer function, giving two regions with 52% and 72% intensity, respectively, corresponding to a ratio of 52/72=0.72 between the two labeled regions. The second overlay image in FIG. 8 shows the same pixel values processed with a different contrast transfer function, with the intensity in the two regions now labeled 99% and 71%, respectively. However, their relative ratio remains essentially unchanged at 71/99=0.72.

(40) The user can modify the transfer function so that a control region is labeled at 100%, wherein all other regions could then be compared to the control region.

(41) FIG. 9 shows that the overlay is transparent where accumulated intensity pixels have a value less than the point where the bottom of the transfer function ramp intersects the horizontal pixel value axis. Further, this demonstrates that in this example 12% of the image area (Coverage number in the lower right of the bottom window) has accumulated intensity greater than 52% of the maximum accumulated intensity. The illustration shows several regions bounded by their 52% contours.

(42) In the aforedescribed approach, the user could place labels on the image to compare relative perfusion of different tissue zones. These labels would normalize the accumulated intensity in a small region beneath the label to the accumulated intensity present in the zone at the top end of the color map range of interest. Although the value of individual labels would vary as the color mapping range was shifted, the ratios of the labels to one another would remain constant.

(43) Practical trials have demonstrated that modifications in the aforedescribed methods would be desirable in order to better quantify the results and allow a more consistent comparison between profused areas. Clinicians generally want to perform a consistent comparison of the perfusion of suspect tissue to that of well-perfused, good tissue. One way of doing that with the original technique described above is to go through the burdensome process of manually adjusting the color mapping range until a label placed on well-perfused tissue reaches 100%. This label may now be used as a good tissue reference. Clinicians generally want to identify whether tissue which exhibits relative accumulated intensity at some percentage as compared to good tissue will suffer from necrosis. Inherent noise in the camera, variable conditions of illumination and surface reflectivity, and the presence of residual ICG in the patient make it difficult to ensure that the ratios are consistent. Although the label ratios remained constant as the color mapping changed, clinicians found it confusing that the label values themselves vary in the process.

(44) In one modified approach, two reference labels are placed on the image, either explicitly in a manual operation or implicitly through automatic computation as described below. The labels are denoted as the background or 0 Marker and the reference or 100 Marker. Any additional labels placed on the accumulated intensity matrix are normalized to the range established by these markers.

(45) Ideally, the 0 Marker will be placed on native tissue outside the transplant flap. The accumulated intensity in a small region beneath this marker denotes background intensity that would result from background noise in the camera, possibly combined with signal from some residual ICG in the patient from prior acquisitions.

(46) Using clinical judgment, the operator places the 100 Marker on tissue that the clinician has identified as being well-perfused, good tissue. This establishes the good tissue reference.

(47) The two markers now support direct normalized quantitative comparison of regions of perfusion on the flap.

(48) Labels values are computed using the following formula:
L=100*(A.sub.labelA.sub.0)/(A.sub.100A.sub.0),
where: A.sub.label represents the accumulated intensity in the area beneath the label A.sub.0 represents the background accumulated intensity in the area beneath the 0 Marker A.sub.100 represents the reference accumulated intensity in the area beneath the 100 Marker

(49) All existing and newly placed label values are now normalized to the range between the 0 Marker and 100 Marker. Label values can exceed 100% and now do not change as the color mapping range is shifted for enhanced visualization.

(50) FIGS. 10A and 10B illustrate an exemplary embodiment of this technique. FIG. 10A is a fluorescence image of the perfused region, similar to those described above with reference to FIGS. 2 to 6. FIG. 10B is a black/white rendition of a colored overlay, with markers or label values computed with the formula:
L=100*(A.sub.labelA.sub.0)/(A.sub.100A.sub.0).

(51) The 0 Marker is denoted in the upper left corner by the circle enclosing a 0 and the 100 Marker is denoted in the upper right corner by the circle enclosing a 100. Because all areas of the tissue show some perfusion, the 0 Marker has been placed on a surgical clip within the field of view.

(52) The following are additional/alternative options for deriving values for the 0 Marker or accumulated background intensity: If no separate 0 Marker is explicitly placed, a value for the 0 Marker can be derived by averaging the accumulated intensity present in the first frame captured prior to the arrival of the ICG bolus. The average accumulated intensity is then computed by multiplying initial frame values by the number of frames in the sequence. Alternatively, in the absence of a separate 0 Marker, a value for the 0 Marker can be derived by first automatically determining what pixels represent tissue and then examining the first frame to compute the average background intensity only for those tissue pixels. The changing pixels are those which receive blood with ICG. To locate these tissue pixels, the software locates pixels whose intensity changes to exceed a predetermined threshold value. Unchanged pixels are disregarded. A physical reference standard or patch with a known near-infrared reflectance may be placed in the field of view. Several of these physical patches would be provided to simulate different skin tones with known reflectance in the visual spectrum. The 0 Marker could then be explicitly placed over these markers to approximate the accumulated intensity underneath the tissue that is not perfused with ICG-laden blood. This would allow normalization to different illumination conditions in the operating room.

(53) In summary, labels can be used to easily compare different perfusion boundaries to the perfusion that is present in known good tissue. These labels now correct for the effects of residual ICG, camera noise, and other NIR scattering effects.

(54) The described embodiments detect a fluorescence signal emitted transcutaneously by ICG following excitation in the near-infrared spectral range. However, those of skill in the art will appreciate that other dyes which can be excited and emit fluorescence in a spectral range where tissue transmits light can also be used.

(55) While the present invention has been described with reference to an example of arterial blood flow, i.e. supply of blood to the perforator vessel(s), the method may also detect graft failure due to venous congestion by quantifying and displaying the rate of change from peak intensity back down to the baseline. This will highlight venous return in the perfusion area.

(56) While the invention is receptive to various modifications, and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that the invention is not limited to the particular forms or methods disclosed, but to the contrary, the invention is meant to cover all modifications, equivalents, and alternatives falling with the spirit and scope of the appended claims.