SYSTEM AND METHOD OF ADVENTITIAL TISSUE CHARACTERIZATION
1. A tangible, non-transient computer readable medium comprising microprocessor executable instructions that, when executed, perform operations comprising:
- receiving, from an intravascular imaging device, image data;
transforming the image data into a frequency domain;
identifying a frequency spectrum for a portion of the image data;
characterizing whether the frequency spectrum corresponds to a region of interest of a blood vessel; and
providing an alert representative of a presence of the region of interest of the blood vessel based on the tissue characterizing step.
Disclosed herein is a system and method for characterizing adventitial tissue. In one aspect, a system and method are disclosed that characterizes tissue types within the adventitial tissue including nerve bundles and blood vessels. In a further aspect, the adventitia is imaged and characterized to provide guidance for crossing lesions within an occluded vessel.
- 1. A tangible, non-transient computer readable medium comprising microprocessor executable instructions that, when executed, perform operations comprising:
receiving, from an intravascular imaging device, image data; transforming the image data into a frequency domain; identifying a frequency spectrum for a portion of the image data; characterizing whether the frequency spectrum corresponds to a region of interest of a blood vessel; and providing an alert representative of a presence of the region of interest of the blood vessel based on the tissue characterizing step.
- View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
- 16. A tangible, non-transient computer readable medium comprising microprocessor executable instructions that, when executed, perform operations comprising:
receiving, from an intravascular imaging device, image data; performing a spectral analysis of the image data and determining a plurality of spectral properties of the image data; identifying one or more of the plurality of spectral properties for a portion of the image data; characterizing whether the spectral properties corresponds to a region of interest of a blood vessel; and providing an alert representative of a presence of the region of interest of the blood vessel based on the characterizing step.
- View Dependent Claims (17, 18, 19)
- 20. A tangible, non-transient computer readable medium comprising microprocessor executable instructions that, when executed, perform operations comprising:
receiving, from an intravascular imaging device, image data; performing a differential analysis of the image data and determining a plurality of properties of the image data, wherein the differential analysis comprises at least one of a frequency analysis, a spectral analysis, an autoregression technique, a wavelet decomposition, and a curvelet decomposition on the image data; identifying one or more of the plurality of properties for a portion of the image data; characterizing whether the properties corresponds to a region of interest of a blood vessel; and
The present application is a continuation U.S. patent application Ser. No. 15/457,795, filed Mar. 13, 2017, which is a continuation of U.S. patent application Ser. No. 14/212,451, filed Mar. 14, 2014, now U.S. Pat. No. 9,592,027, which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/784,570, filed Mar. 14, 2013, which are hereby incorporated by reference in its entireties.
The present disclosure relates generally to tissue characterization and more particularly to procedures utilization tissue characterization of the adventitial tissues.
Intravascular tissue characterization is currently performed in conjunction with the evaluation of lesions within the lumens of vessels. Such characterization generally evaluates the properties of the lesion and provides a graphic display of the tissue types for the user. Example of such tissue characterization techniques are disclosed in U.S. Pat. Nos. 7,627,156 and 7,789,834, each of which is hereby incorporated by reference in its entirety. While these systems have been sufficient at providing information concerning properties of the lesion, there remains a need to determine additional information about the vessel and surrounding supportive tissue to evaluate vessel health and determine appropriate therapies. Such additional features can also consider further aspects about prosthetic devices positioned in the vasculature.
In addition, intravascular imaging systems have been developed to identify the border between different layers within a vessel. For example, U.S. Pat. Nos. 7,463,759 and 8,233,718, each of which is incorporated herein by reference in its entirety, disclose techniques for determining the borders been various regions within the vessel. Although such techniques provide valuable information in many situations, when occlusions have disrupted vessel layer boundaries or the imaging device is not directed perpendicular to the boundaries, such boundaries may be difficult or impossible to image. Thus, there remains a need for better imaging techniques to provide additional information concerning the vessel walls.
The devices, systems, and methods disclosed herein overcome one or more of the deficiencies of the prior art.
In one aspect, the present disclosure provides a system and method for performing tissue characterization of adventitial tissue of a vessel. Among other features, the adventitial tissue characterization information can assist the user in one or more of the following: evaluation of the location of nerve bundles, evaluation of tissue to be ablated, the amount of energy to utilize, the extent of the area to be ablated, damage to adjacent tissue, the direction of the tissue to be ablated, the depth of ablation, amount and direction of vasa vasorum, myocardium encroachment or positioning adjacent the adventitial tissue, and guidance across through occlusions within a vessel.
In one embodiment, the present disclosure provides a method that includes imaging a vessel including surrounding adventitial tissue and performing tissue characterization on the adventitial tissue. The results of the adventitial tissue characterization can then be displayed to a user. In one aspect, the display is a colorized display overlaid on an intravascular ultrasound image. In another aspect, the image is a three dimensional model highlighted with color to illustrate structures identified within the adventitial tissue. In one aspect, the tissue characterization includes identifying nerve bundles within the adventitial tissue. In another aspect, the imaging includes imaging the adventitia and the perivascular supportive tissue surrounding an artery and the identifying includes identifying nerve bundles within the perivascular tissue. In a further aspect, the method includes identifying myocardial muscular tissue surrounding the vessel and displaying the location to a user. In another aspect, the tissue characterization includes identifying and displaying vasa vasorum within the adventitial tissue. In another further aspect, the tissue characterization includes identifying the transition of the medial to adventitial tissue and the location of the adventitial tissue.
In another aspect of the present disclosure, a method is provided for performing a first imaging of the vessel and first tissue characterization of the adventitial tissue of the vessel, conducting a therapy on the vessel, performing a second imaging of the vessel and second tissue characterization of the adventitial tissue of the vessel, comparing the first and second tissue characterizations and displaying the differences to the user. In one aspect, additional therapy can be delivered based on the differences displayed to the user. In one embodiment, the therapy is includes an ablation therapy. In another form, the therapy includes stenting within the vessel. In still a further aspect, the time between delivery of the therapy and the second imaging is a period of at least several days, and the differences displayed illustrate changes to tissue within or around the stent and/or changes to the stent structure itself.
In still a further aspect, the present disclosure provides a system for adventitial tissue characterization. The system includes a data base of known adventitial tissue patterns, a sensor for collecting imaging data from a vessel, and a processor configured to compare the sensor imaging data to the data base of known adventitial tissue patterns and determine tissue characterizations within the adventitial tissues.
In yet a further aspect, the present disclosure provides a method for utilizing tissue characterization in image guided therapy. In one aspect, the method includes positioning an imaging device and a therapy device within the lumen of a vessel and imaging the vessel including the adventitial tissue surrounding at least a portion of the lumen. The method continues with performing tissue characterization on the adventitial tissue and displaying adventitial tissue characteristics to a use. The position of the therapy device can then be changed in response to the displayed adventitial tissue characteristics. In one aspect, the method includes defining a longitudinal direction of the therapy device and alerting to the user to the presence of adventitial tissue in the longitudinal direction of the therapy device. In still a further aspect, the therapy device is a chronic total occlusion crossing device and the changing includes changing the longitudinal direction of the device. In yet a further aspect, the therapy device is an ablation device and the changing includes changing the longitudinal or radial position of the ablation device within the vessel in response to the adventitial tissue characteristics.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory in nature and are intended to provide an understanding of the present disclosure without limiting the scope of the present disclosure. In that regard, additional aspects, features, and advantages of the present disclosure will be apparent to one skilled in the art from the following detailed description.
The accompanying drawings illustrate embodiments of the devices and methods disclosed herein and together with the description, serve to explain the principles of the present disclosure. Throughout this description, like elements, in whatever embodiment described, refer to common elements wherever referred to and referenced by the same reference number. The characteristics, attributes, functions, interrelations ascribed to a particular element in one location apply to those elements when referred to by the same reference number in another location unless specifically stated otherwise.
The figures referenced below are drawn for ease of explanation of the basic teachings of the present disclosure only; the extensions of the figures with respect to number, position, relationship and dimensions of the parts to form the preferred embodiment will be explained or will be within the skill of the art after the following description has been read and understood. Further, the exact dimensions and dimensional proportions to conform to specific force, weight, strength and similar requirements will likewise be within the skill of the art after the following description has been read and understood.
The following is a brief description of each figure used to describe the present invention, and thus, is being presented for illustrative purposes only and should not be limitative of the scope of the present invention.
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications to the described devices, instruments, methods, and any further application of the principles of the present disclosure are fully contemplated as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. For simplicity, in some instances the same reference numbers are used throughout the drawings to refer to the same or like parts.
The present disclosure relates generally to an apparatus, systems, and methods for image-guided diagnostic procedures and monitoring of therapy delivery procedures through adventitial tissue characterization. The present disclosure describes systems and methods for tissue characterization by analyzing images created by an energy emission device, such as, by way of non-limiting example, an ultrasound transducer, deployable with an imaging system to facilitate interpretation of images of vessel adventitial tissues, including ablated and neighboring tissue. The systems and methods described herein correlate image properties of the adventitial tissue with pre-determined tissue properties to automatically and reproducibly characterize the adventitial tissues in real time (i.e., as the tissues are being imaged and/or ablated). By automatically and reproducibly characterizing the adventitial tissues in real time, the systems and methods described herein minimize the known observer-variability associated with tissue characterization by observers. As used herein, unless expressly indicated otherwise, the adventitial tissues being referred to and characterized are the tissue layers immediately outside the media along with the perivascular supportive tissues surrounding the adventitia that include various intermingled tissue types generally within about 3-5 mm of the media that can include nerves, nerve bundles, blood vessels, muscle fibers (especially in the coronary arteries), connective tissue, fibroblasts and fat cells.
The interface 140 is configured to connect the catheter 110 to a patient interface module or controller 210, which may include a graphic user interface (GUI) 215, such as a display or a touch screen. More specifically, in some instances the interface 140 is configured to communicatively connect at least the imaging apparatus 180 and the ablative element 170 of the catheter 110 to a controller 210 suitable for carrying out ablation and intravascular imaging. The controller 210 is in communication with and performs specific user-directed control functions targeted to a specific device or component of the system 100, such as the ablation catheter 110, the imaging apparatus 180, and/or the ablative element 170.
The interface 140 may also be configured to include a plurality of electrical connections, each electrically coupled to the ablative element 170 via a dedicated conductor and/or a cable (not shown), respectively, running through the lumen 125 of the body 120. Such a configuration allows for a specific group or subset of electrodes on the ablative element 170 to be easily energized with either monopolar or bipolar energy, for example. Such a configuration may also allow the ablative element 170 to transmit data from any of a variety of sensors on the ablative element via the controller 210 to data display modules such as a GUI 215 and/or a processor 220. The interface 140 is coupled to an ablation source 225 via the controller 210, with the controller 210 allowing energy to be selectively directed to the portion of the target tissue that is engaged by the ablative element 170.
In the pictured embodiment, the imaging apparatus 180 comprises an ultrasound imaging transducer. The imaging apparatus 180 can take the form of any one of a number of known ultrasound imaging transducers, such as, for example and without limitation, a phased array, a forward-looking array, a mechanically steered sector array, a rotational transducer, a vector array, a forward-looking oscillator transducer or a linear array. For example, in some embodiments involving cardiac ablation applications, the imaging apparatus comprises intracardiac echocardiography (ICE) or forward-looking ICE. The imaging apparatus has an imaging field of view 223 that may or may not overlap with the ablating field 221. In the pictured embodiment, the imaging field of view 223 is shown overlapping with the ablating field 221, thereby allowing the user to image the tissue being ablated within the ablating field 221 in real-time.
It should be appreciated that while the exemplary embodiments herein are described in terms of an ultrasonic imaging apparatus, or more particularly the use of IVUS data (or a transformation thereof) to render images of an object, the present disclosure is not so limited. Thus, for example, an imaging apparatus using backscattered data (or a transformation thereof) based on electromagnetic radiation (e.g., light waves in non-visible ranges such as Optical Coherence Tomography, X-Ray CT, infrared spectroscopy, etc.) to render images of any tissue type or composition (not limited to vasculature, but including other human as well as non-human structures) is within the spirit and scope of the present disclosure. Any form of imaging, measuring, and/or evaluation device (and resultant data) is within the spirit and scope of the present disclosure. Still further, while the system and techniques are described in the context of an invasive ultrasound system, it will be appreciated that the system and method of conducting tissue characterization may be accomplished throughout the body whether tissues are accessed through natural openings or through openings formed through the skin.
The controller 210 is connected to the processor 220, which is typically an integrated circuit with power, input, and output pins capable of performing logic functions, an imaging energy generator 222, and the ablation source 225. The processor 220 may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), or equivalent discrete or integrated logic circuitry. In some examples, processor 220 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, or one or more FPGAs, as well as other discrete or integrated logic circuitry. The functions attributed to processor 220 herein may be embodied as software, firmware, hardware or any combination thereof.
The processor 220 may include one or more programmable processor units running programmable code instructions for implementing the ablative methods described herein, among other functions. The processor 220 may be integrated within a computer and/or other types of processor-based devices suitable for a variety of intravascular applications, including, by way of non-limiting example, ablation, intravascular imaging, and tissue characterization. The processor 220 can receive input data from the controller 210, a memory 245, a tissue pattern recognition database 250 usable for tissue characterization, accessory devices 240, the imaging apparatus 180, and/or the ablative element 170 directly or via wireless mechanisms. The processor 220 can interpret and use such input data to generate control signals to control or direct the operation of the catheter 110. In some embodiments, the user can program or direct the operation of the catheter 110 and/or the accessory devices 240 from the controller 210 and/or the GUI 215. In some embodiments, the processor 220 is in wireless communication with the imaging apparatus 180 and/or the ablative element 170, and can receive data from and send commands directly to the imaging apparatus 180 and/or the ablative element 170.
In various embodiments, the processor 220 is a targeted device controller that may be connected to a power source 230, accessory devices 240, the memory 245, and/or the ablation source 225. In such a case, the processor 220 is in communication with and performs specific control functions targeted to a specific device or component of the system 100, such as the imaging apparatus 180 and/or the ablative element 170, without utilizing user input from the controller 210. For example, the processor 220 may direct or program the imaging apparatus 180 and/or the ablative element 170 to function for a period of time without specific user input to the controller 210. In some embodiments, the processor 220 is programmable so that it can function to simultaneously control and communicate with more than one component of the system 100, including the accessory devices 240, the power source 230, and/or the ablation source 225. In other embodiments, the system includes more than one processor and each processor is a special purpose controller configured to control individual components of the system.
In the pictured embodiment, the controller 210 is configured to couple the imaging apparatus 180 to the imaging energy generator 222. In embodiments where the imaging apparatus 180 is an intravascular ultrasound (IVUS) transducer(s), the imaging energy generator comprises an ultrasound energy generator. Under the user-directed operation of the controller 210, the imaging energy generator 222 may generate a selected form and magnitude of energy (e.g., a particular energy frequency) best suited to a particular application. At least one supply wire (not shown) passing through the body 120 and the interface 140 connects the imaging apparatus 180 to the imaging energy generator 222. The user may use the controller 130 to initiate, terminate, and adjust various operational characteristics of the imaging energy generator 222.
The power source 230 may be a rechargeable battery, such as a lithium ion or lithium polymer battery, although other types of batteries may be employed. In other embodiments, any other type of power cell is appropriate for power source 230. The power source 230 provides power to the system 100, and more particularly to the processor 220. The power source 230 may be an external supply of energy received through an electrical outlet. In some examples, sufficient power is provided through on-board batteries and/or wireless powering.
The various peripheral devices 240 may enable or improve input/output functionality of the processor 220. Such peripheral devices 240 include, but are not necessarily limited to, standard input devices (such as a mouse, joystick, keyboard, etc.), standard output devices (such as a printer, speakers, a projector, graphical display screens, etc.), a CD-ROM drive, a flash drive, a network connection, and electrical connections between the processor 220 and other components of the system 100. By way of non-limiting example, a processor may manipulate signals from the imaging apparatus 180 to generate an image on a display device, may coordinate aspiration, irrigation, and/or thermal neuromodulation, and may register the treatment with the image. Such peripheral devices 240 may also be used for downloading software containing processor instructions to enable general operation of the catheter 110, and for downloading software implemented programs to perform operations to control, for example, the operation of any auxiliary devices attached to the catheter 110. In some embodiments, the processor may include a plurality of processing units employed in a wide range of centralized or remotely distributed data processing schemes.
The memory or database 245 is typically a semiconductor memory such as, for example, read-only memory, a random-access memory, a FRAM, or a NAND flash memory. The memory 245 interfaces with processor 220 such that the processor 220 can write to and read from the memory 345. For example, the processor 220 can be configured to read data from the imaging apparatus 180 and write that data to the memory 345. In this manner, a series of data readings can be stored in the memory 245. The processor 220 is also capable of performing other basic memory functions, such as erasing or overwriting the memory 245, detecting when the memory 345 is full, and other common functions associated with managing semiconductor memory. In the pictured embodiment, the memory 245 comprises a database of characterization data.
The tissue pattern recognition or characterization application 250 is adapted to receive data (e.g., imaging data) from the processor 220 and/or the controller 210. The characterization application may exist as a single application or as multiple applications and be locally or remotely stored. In an exemplary embodiment, the characterization application 250 is adapted to receive and store characterization data (e.g., tissue type, adventitial characteristics, ablation characteristics, stent characteristics, myocardium characteristics, and secondary parameters or patterns). In particular, to create a database of characterization data, after a tissue specimen has been imaged and IVUS data has been collected, a histology correlation is prepared by collecting, dissecting, and preparing the tissue specimen for slide review (e.g., fixing and staining the tissue specimen with a process that is well known in the art). Slide review allows a clinician to identify and characterize the tissue type(s) and/or histological chemicals/markers (i.e., chemicals and/or markers associated with particular tissue types) found within the specimen. It should be noted that the particular method used to characterize the tissue specimen is not a limitation of the present disclosure, and all tissue specimen characterization methods generally known to those skilled in the art are within the scope of the present disclosure.
In one embodiment, the tissue specimen comprises a region of ablated tissue. The tissue may be any of a variety of tissue types, including, by way of non-limiting example, muscle tissue, fatty tissue, fibrous tissue, fibrolipidic tissue, vessel tissue (e.g., by way of non-limiting example, compositional tissues such as vessel wall, luminal wall, medial-adventitial boundary, adventitial tissue, myocardium), neural tissue, calcific tissue, necrotic tissue, calcified-necrotic tissue, collagen compositions, cholesterol deposits, and/or adventitial tissue. In addition, the tissue specimen can comprise ablated tissue in any of a variety of stages of ablation, including, by way of non-limiting example, minimally ablated tissue, moderately ablated tissue, majorly ablated tissue, and/or completely ablated tissue. The characterization data gathered from the tissue specimens can include all other identifiable characteristics generally known to those of skill in the art. In some embodiments, tissue specimens having a full range of varying degrees of ablation per tissue type are interrogated (imaged and histologically sectioned) for inclusion in the characterization application 250.
The identified tissue type(s) and/or characterization conclusions are provided to the characterization application 250 as characterization data. In some embodiments, the characterization data is provided via the GUI 215 or another input device that is electrically coupled to the controller 210 and/or the processor 220. The characterization data is then stored in the memory or database 245.
In one embodiment, the characterization application 250 is adapted to create a histology image of the tissue specimen and to identify the at least one corresponding region on an image (e.g., an IVUS image) of the tissue specimen. A region of interest (ROI) on the histology image (which may be provided to the characterization application 250 via the GUI 215 or another input device in the form of digitized data that is used to create the histology image) can then be identified by the user. The ROI may be characterized by the characterization data, and can comprise the whole tissue specimen or only a portion thereof. The characterization application is adapted to identify a corresponding region on the scanned image (e.g., IVUS image).
In some instances, the histology image may need to be morphed or warped to accurately match and substantially fit the contour of the IVUS image (thereby removing histological preparation artifacts). In some embodiments, therefore, the characterization application 250 is adapted to morph or warp the histology image to accurately match the IVUS image. Specifically, the characterization application 250 is configured to identify at least one landmark common to both the histology image and the IVUS image and is adapted to use various algorithms to substantially align the two images. The landmark may comprise an anatomic landmark (such as, by way of non-limiting example, side-branch vessels, a vessel wall, and a tumor border) or a marker (such as, by way of non-limiting example, a suture tie or an inked mark). In one embodiment, the characterization application is adapted to use a first algorithm (e.g., a morphometric algorithm) to substantially align the corresponding landmarks and a second algorithm (e.g., a thin plate spline (TPS) deformation technique) to substantially align the non-landmark portions of the object.
In one embodiment, the characterization application 250 is further adapted to determine and store at least one parameter associated with the ROI portion of the IVUS image. In particular, the characterization application 250 is adapted to identify the IVUS data (i.e., the raw backscatter data) that corresponds to the ROI identified on the IVUS image (i.e., the IVUS data that was originally used to create the ROI on the IVUS image). Different types and densities of tissue absorb and reflect emitted energy differently. Each reflected signal is characteristic of the type of tissue and the condition of the tissue that reflected it. Differences in the reflected signal along each path can be determined by performing analysis on the signals. As a result, identifying different signal characteristics along each reflected path allows for a correlation to the type of tissue and the condition of the tissue associated with those particular signal characteristics. As will be described below, the signal characteristics of each reflected signal can serve as a signature for different types of components within the scanned tissue, including, for example and without limitation, necrotic plaque components within an artery, adventitia, neural tissue, minimally ablated muscle tissue, or completely ablated neural tissue.
The at least one parameter is then stored in the memory 245, where it is linked to the characterization data associated with the ROI. Each parameter may be associated with more than one tissue type or degree of ablation. For example, a first parameter may be common to multiple tissue types and multiple degrees of ablation. In some embodiments, signal analysis (i.e., frequency analysis, etc.) is performed on the identified IVUS data before the parameters are identified because the frequency information can serve as a “signature” for a particular tissue type or characteristic. The IVUS data may be converted or transformed into the frequency domain to identify the specific frequency spectrum of the ROI. The characterization application 250 and this transformation process are described in further detail below with reference to
It should be appreciated that the number and location of the components depicted in
An exemplary method of populating the training database or memory 245 is illustrated in
The process depicted in
Referring more specifically to
With reference back to
Referring now to the example shown in
The signal properties of the transmit and receive signals are processed by the characterization application 250, which is configured to correlate the signal properties of the scan line segment with the type of tissue component having those or similar signal properties. In that regard, the characterization application 250 is configured to compare and match the signal properties to pre-determined or pre-generated adventitial tissue signal properties contained within the memory or database 245. Various parameters may comprise the database of pre-determined tissue signal properties. The parameters comprising the database 245 would be pertinent to both the desired application or tissue-of-interest and the imaging modality of the imaging probe (i.e., ultrasound, OCT, spectroscopy, etc.). The characterization application 250 is configured to recognize the type of imaging modality employed by the imaging probe 110 and to use the appropriate pre-determined tissue signal properties associated with that particular imaging modality. For example, if the imaging modality being used were ultrasound, the pre-determined signal properties may include various parameters in the spectral domain directly associated with scatter size, density, viscosity, and their acoustic properties such as impedance and attenuation coefficient. The pattern recognition training database also contains macro-data about overall characteristics, such as size, nerve cell directionality, vasa vasorum directionality, morphology, as well as patient demographic information such as age, gender, race and relevant medical history, such as known diabetic, cardiovascular disease, hypertension information and others.
In some embodiments, the imaging system 100 may employ a multitude of different imaging modalities to image the same object such as blood vessel 450. In some embodiments, these imaging modalities are used sequentially, whereas in other embodiments, the different imaging modalities are used simultaneously (e.g., using a multi-modality imaging apparatus). In one example, the imaging probe is first energized to image the adjacent tissue of the vessel with a 40 MHz ultrasonic pulse. Following the first imaging pass of the probe, the imaging probe is energized to image the adjacent tissue with a 20 MHz ultrasonic pulse. In such a system, the image data from both passes may be compared to corresponding data in by the characterization application 250. In still a further aspect, the imaging probe may be constructed to provide and detect harmonic variations of the center frequency such that different frequencies can be detected within a single pulse. In still a further embodiment, the imaging probe 110 may be configured to image the object using a multitude of different imaging modalities (e.g., OCT and ultrasound). In some embodiments, the characterization application 250 is configured to combine or analyze the pre-determined signal properties and patterns associated with each imaging modality used to perform adventitial tissue characterization.
Secondary parameters may be included within the data structure to reflect the type of tissue and/or the particular pre-existing conditions or differential diagnoses of the patient. The secondary parameters may be utilized by the correlation logic to more accurately compare and match the signal properties to the pre-determined signal properties 480. One secondary parameter may comprise the type of vessel being observed. For example, in larger vessels the vessel walls may be much thicker and the overall diameter of the vessel may be much larger. Thus, it is anticipated that the imaging device may need to be positioned closer to one wall within a large vessel to perform adventitial tissue characterization on only a portion while in a smaller vessel, such as a coronary artery, it may be possible to perform adventitial tissue characterization on the full circumference of the adventitial tissue. In some embodiments, the imaging system 100 can determine the type of tissue or anatomic region observed with the vessel and use this as a secondary parameter before automatically selecting the appropriate pre-determined signal properties associated with the type of tissue or anatomic region or appropriately adjusting the pre-determined signal properties to reflect the type of tissue or anatomic region. In other embodiments, the user may enter the type of tissue or anatomic region manually (e.g., via the GUI 215), and either the user or the imaging system 100 may select the appropriate pre-determined signal properties associated with that type of tissue/region or appropriately adjust the pre-determined signal properties to reflect this type of tissue/region. For example, if the tissue being scanned includes a calcified vascular plaque, either the user or the imaging system 100 may select the appropriate pre-determined signal properties associated with calcified plaque tissue or appropriately adjust the pre-determined signal properties to reflect changes observed for calcified plaque tissue. In some embodiments, a three-dimensional data set can be constructed with the imaging apparatus 110 to provide further parameters related to tissue type and matched back to the secondary parameters in the database 245 that contains these pre-determined ablation values for various tissue types.
Another secondary parameter associated with the imaging may comprise the particular frequency or harmonics employed by the imaging apparatus 110. For example, the database 245 may contain particular sets of pre-determined signal properties associated with particulars frequencies or harmonic patterns.
With reference again to
In one embodiment, the signal analyzer logic includes logic to transform the data to the frequency domain and analyze frequency information of the signals to determine one or more signal properties. It will be appreciated that the signal analyzer logic may be embodied as part of an ultrasound imaging console, an ablation system console, or as part of a separate system that receives raw radio frequency data from an ultrasound apparatus. If the radio frequency data is in analog form, a digitizer may be provided to digitize the data. A signal processing logic is configured to process each scan line of the ultrasound data and transform it to a format that can be analyzed. To reduce processing time, a border detection or segmentation logic may be used to determine the location of the borders of the object being scanned, particularly the border between the media and the adventitia such that the characterization application 250 can focus on analyzing the echo returns from adventitial tissue extending beyond the media including the perivascular tissues. Because the analysis is most interested in the components of the adventitial tissue, scan line data outside of the adventitial tissue can be filtered and removed. One example of a border detection system is described in U.S. Pat. No. 6,381,350, entitled “Intravascular Ultrasonic Analysis Using Active Contour Method and System,” which is incorporated herein by reference for all purposes.
After border detection, the scan line data is transformed. Of course, border detection can be performed after transformation. Transformation logic is configured to transform the remaining scan line data into a format suitable for analysis. In general, the transformed format should match the same format used to build the pre-determined signal properties of the object component. In one embodiment, the transformation logic transforms the data to a power spectrum plot of frequency versus power output. Various transformation algorithms include a Fourier transformation, Welch periodograms, and auto-regressive modeling. Other types of transformations can include transforming the data to wavelets that provide an image with frequency and time information. For example, other signal processing techniques may include wavelet decomposition or curvelet decomposition to deliver parameters that are relevant for discrimination between tissue types while not being influenced by the system transfer function of the imaging system and probe. Another transformation includes using impedance, rather than frequency, which gives an image of acoustic impedance. In this format, different tissue components have different impedance properties that provide different signal reflections.
A variety of pattern recognition approaches may be used by the classification logic and/or correlation logic. For example, the database 245 of relevant secondary parameters and pre-determined tissue signal properties could be the starting point of various pattern recognition approaches, covering, but not limited to, classification trees, random forests, neural networks, regression trees, principal components, and/or a combination of these to arrive at an accurate tissue characterization. For example, in one embodiment, the pre-determined tissue signal properties and/or the secondary parameters may be stored in the database 245 as a classification tree or a regression tree having branch node conditions based on the pre-determined tissue signal properties and one or more leaf nodes that identify a tissue component of adventitial tissue. In another embodiment, the pre-determined tissue signal properties may be embodied in the database as an artificial neural network having one or more nodes that identify a tissue component of adventitial tissue. In some embodiments, the classification logic and/or the correlation logic may utilize a random forest classifier to analyze a number of classification trees (e.g., different classification trees based on different pre-determined signal properties or based on a multitude of different imaging modalities) to arrive at a tissue characterization.
The characterization application 250 may be configured to reconstruct the received data into displayed 2D or 3D images, and the identified adventitia components may be visually distinguished on a display associated with the GUI 215. In some embodiments, a display may be included as a component of an imaging system console (not shown). In other embodiments, the display may be an independently located device that communicates either wirelessly or through a wired connection with the characterization system 100. In some embodiments, the display may be remotely located.
Referring now to
The imaging apparatus 100 in the pictured embodiment is an intravascular ultrasound (IVUS) apparatus. The entire IVUS apparatus may extend through the body and include all the components associated with an IVUS module, such as a transducer(s), multiplexer(s), electrical connection(s), etc., for performing IVUS imaging. The imaging apparatus 100 of the pictured embodiment may utilize any IVUS configuration that allows at least a portion of the body to be introduced over a guidewire. For example, in some instances, the imaging apparatus utilizes an array of transducers (e.g., 32, 64, 128, or other number transducers) disposed circumferentially about the central lumen 925 of the body 920 in a fixed orientation. In other embodiments, the IVUS portion is a rotational IVUS system. In some instances, the imaging apparatus includes components similar or identical to those found in IVUS products from Volcano Corporation, such as the Eagle Eye® Gold Catheter, the Visions® PV8.2F Catheter, the Visions® PV 0.018 Catheter, the Visions® PV 0.035 Catheter and/or the Revolution® 45 MHz Catheter, and/or IVUS products available from other manufacturers. Further, in some instances the catheter 850 includes components or features similar or identical to those disclosed in U.S. Pat. Nos. 4,917,097, 5,368,037, 5,453,575, 5,603,327, 5,779,644, 5,857,974, 5,876,344, 5,921,931, 5,938,615, 6,049,958, 6,080,109, 6,123,673, 6,165,128, 6,283,920, 6,309,339; 6,033,357, 6,457,365, 6,712,767, 6,725,081, 6,767,327, 6,776,763, 6,779,257, 6,780,157, 6,899,682, 6,962,567, 6,976,965, 7,097,620, 7,226,417, 7,641,480, 7,676,910, 7,711,413, and 7,736,317, each of which is hereby incorporated by reference in its entirety.
In alternate embodiments, the imaging apparatus 980 may be or include, by way of non-limiting example, any of grey-scale IVUS, forward-looking IVUS, rotational IVUS, phased array IVUS, solid state IVUS, spectroscopy, or optical coherence tomography. It is understood that, in some instances, wires associated with the imaging apparatus extend along the length of the elongated tubular body through the handle and along electrical connection to the interface such that signals from the imaging apparatus can be communicated to the controller. In some instances, the imaging apparatus communicates wirelessly with the controller and/or the processor.
The devices, systems, and methods described herein may be used to characterize tissue and provide real-time feedback as to the level of ablation during a variety of diagnostic, ablation and/or neuromodulation applications, including without limitation: carotid body ablation, cardiac ablation (including myocardial), renal neuromodulation, intravascular lesion ablation, and chronic total occlusion crossing. In each of these embodiments, the database or memory would be configured to contain pre-determined tissue imaging properties and secondary parameters associated with particular types of tissue at varying levels of ablation. The imaging apparatus utilizes this database 245 to compare and correlate the signal properties of the tissue-of-interest with the pre-determined properties to accurately characterize the tissue.
Referring now to
Referring now to
Referring now to
Referring to the right half of
Referring now to
Referring now to
Referring now to
Referring now to
While the present invention has been illustrated by the description of embodiments thereof, and while the embodiments have been described in considerable detail, it is not the intention of the applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. Therefore, the invention, in its broader aspects, is not limited to the specific details, the representative apparatus, and illustrative examples shown and described. Accordingly, departures may be made from such details without departing from the spirit or scope of the applicant'"'"'s general inventive concept.
Persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In that regard, although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and, in a manner, consistent with the present disclosure.