Medical imaging diagnostic device, system, and method

Abstract

A medical imaging diagnostic device (10) is provided, comprising a flexible skin patch (12) including an adhesive layer (14) on an underside (16) thereof and at least one fiducial marker (18) secured to an upper side (20) of the skin patch (12). The fiducial marker (18) comprises a radiopaque core (22) and an infrared-reflective coating (24). In this manner, the skin patch (12) can be removably adhered to the skin (26), and the fiducial marker (18) is detectable as a single location in space via both stereoscopic computer vision (28) and computed tomography imaging (30) modalities, enabling correlation between virtual and physical space as a navigation aid for image-guided medical procedures. Related medical imaging diagnostic systems (32) and methods are also included.

Description

[Technical Field]

[0001] The present invention relates generally to medical imaging and related image-guided medical procedures, and more particularly to medical imaging devices, systems, and related methods. [Background technology]

[0002] The following discussion of the background art is intended solely to facilitate an understanding of the present invention, and is not intended as an admission or acknowledgement that any of the material referred to is or was part of the common general knowledge as of the priority date of this application.

[0003] Medical imaging is known and traditionally is the process of imaging the interior of the body for clinical analysis and medical intervention, as well as visual representation of the function of some organs or tissues. Generally, medical imaging aims to reveal internal structures hidden beneath the skin and bones, and to diagnose and treat disease.

[0004] For example, a computed tomography scan (CT scan) is a medical imaging technique used to obtain detailed internal images of the body. CT scanners typically use a rotating X-ray tube and an array of detectors mounted on an opposing gantry to measure the attenuation of X-rays by various tissues in the body. Multiple X-ray measurements taken from different angles are then typically processed on a computer using tomographic reconstruction algorithms to generate cross-sectional or sectional images, or "virtual slices," of the body.

[0005] The availability of medical imaging has led to the development of image-guided surgery and related medical procedures. Image-guided surgery generally refers to surgical procedures in which physicians use tracked surgical instruments in conjunction with preoperative or intraoperative medical images to directly or indirectly guide the procedure. Image-guided surgery typically helps surgeons perform safer, less invasive procedures and has become recognized as the standard of care in managing diseases, including cranial, ENT, spine, orthopedic, and cardiovascular. For example, in addition to its role as a diagnostic imaging modality, CT is routinely used as a guidance tool for many interventional radiology procedures, including biopsy, aspiration, drain placement, and thermal ablation.

[0006] Accuracy of navigation during image-guided surgery and related medical procedures is essential to ensure patient safety and avoidance of complications, and various navigation systems have been developed. Two metrics commonly used to evaluate the accuracy of navigation systems are root mean square (RMS) and target registration error (TRE). RMS is a calculation of the error between "theoretical" points selected as fiducial markers or anatomical landmarks and "ground truth" from the patient's preoperative imaging, such as a computed tomography (CT) scan.

[0007] Applicant has identified shortcomings in conventional CT-guided procedural techniques in measuring the difference between the actual locations of fiducials or anatomical landmarks in three-dimensional (3D) space and the predicted locations of such navigation points according to the patient's on-site or preoperative CT imaging. To achieve as close a match as possible between the anatomical landmarks and the preoperative imaging, conventional procedures are often performed using invasive and repetitive methods, resulting in increased risk to the patient and unnecessary time and radiation exposure.

[0008] For example, current practice often relies on tracking systems along with bone anchor markers for fusion between virtual space (via X-ray) and physical space (via bone anchor markers), where anatomical landmarks scanned with X-rays can be integrated with physical markers. Such bone anchor markers essentially require an invasive procedure performed by a surgeon who accesses the bone through an incision, as opposed to many physicians and radiologists who perform minimally invasive procedures using CT guidance.

[0009] An example of such a conventional practice is described in European Patent Application No. EP 3936079 A1 by Spine Align LLC, which describes various intraoperative alignment assessment practices, i.e., alignment assessment practices that occur or are performed during the course of a surgical procedure. These practices are illustrated using a trackable surgical tool that includes a dynamic reference frame for the tool. Some embodiments of the present invention include an assembly with an array of 3D tracking markers available for discrete signaling to an acquisition system. In some embodiments, the assembly includes four tracking markers that form a dynamic reference frame (DRF) and two tracking stray markers (TSMs). In some embodiments, the center of the assembly includes a rotating shield that can be positioned to cover selected TSMs or not cover them at all. In some embodiments, because the tool geometry is known, the acquisition system software can interpret which TSMs are exposed, and based on pre-programmed combinations, the tool can communicate discrete messages with the acquisition system. In some embodiments, for example, if a first TSM is covered, this indicates that the system is in a particular state, while if a second TSM is covered, this indicates a different state. In some embodiments, because the tool includes a DRF, its position and pose can be interpreted with a 3D tracking camera, and the placement of covered and uncovered stray markers can be used to communicate specific commands or device states. This approach is used to indicate anatomical reference axes to the user that might otherwise be difficult to interpret.

[0010] This prior art system allows software to use CT scans to interpret the location of exposed regions and initialize the patient prior to intraoperative assessment of spinal alignment, and such intraoperative interpretation of acquired data can be performed with or without the use of fiducial landmarks, such as skin-attachable fiducial markers. In this way, based on the preoperative and / or intraoperative data initialization, it is possible to initialize the patient's anatomy by calculating displacement vectors from one region of interest to another, representing the location of unexposed regions.

[0011] These prior art methods are cumbersome, inaccurate (e.g., requiring invasive procedures to improve accuracy via attachment of bone markers), computationally intensive to implement, and do not provide immediate feedback when the dynamic reference frame or position of the surgical instrument changes. The present invention was devised with these shortcomings in mind and with the objective of improving upon such prior methods. Summary of the Invention

[0012] Those skilled in the art will understand that references herein to "stereoscopic computer vision" generally refer to any suitable technology for implementing artificial systems that can obtain information from multi-dimensional objects in space, and any suitable arrangement that addresses how a computer or similar processing system can obtain positional information for objects in three-dimensional space, as conventionally known in the art of computer and vision engineering.

[0013] It should also be understood that references herein to "real time" are understood to mean points in time that may include delays that typically result from processing, computation, and / or transmission times inherent in electronic processing systems. These transmission and computation times generally result in small, but measurable delays, typically less than a second, or even within milliseconds or microseconds, while feedback is provided relatively quickly, substantially instantaneously, or in substantial "real time."

[0014] According to a first aspect of the present invention, there is provided a medical imaging diagnostic apparatus, the apparatus comprising: a flexible skin patch having an adhesive layer on the underside so as to be removably adhered to the skin in use; at least one fiducial marker secured to an upper side of said skin patch, i. a radiopaque core detectable via a first imaging modality; and ii. an infrared reflective coating detectable via a second imaging modality; and a fiducial marker including The fiducial marker is detectable as a shared single location in space via both the first and second imaging modalities to enable real-time correlation of virtual and physical spaces as a navigation aid for image-guided medical procedures.

[0015] Those skilled in the art will appreciate that the first and second imaging modalities may be operable or responsive to different electromagnetic spectrums.

[0016] In one embodiment, the first imaging modality comprises a computed tomography, or CT scan.

[0017] In one embodiment, the second imaging modality includes stereoscopic computer vision.

[0018] Those skilled in the art will understand that a flexible skin patch generally includes a relatively small bandage, adhesive bandage, or skin dressing that can be removably adhered to a patient's skin. Similarly, references to "virtual space" generally refer to three-dimensional space established via computed tomography imaging modalities, and "physical space" refers to three-dimensional space established via stereoscopic computer vision modalities.

[0019] In one embodiment, the flexible skin patch is made from a woven fabric, a polymer such as PVC, polyethylene, or polyurethane, or latex.

[0020] In one embodiment, the adhesive layer comprises an acrylate, such as a methacrylate and an epoxy diacrylate.

[0021] In one embodiment, the fiducial markers are fabricated from a radiopaque material that is also infrared reflective, for example a metal such as gold.

[0022] According to a second aspect of the present invention, there is provided a medical image diagnostic system, the system comprising: a stereoscopic computer vision system configured to monitor a physical space near the patient; a computed tomography scanner configured to perform a CT scan to generate a virtual space of the patient; at least one medical imaging device comprising a flexible skin patch having an adhesive layer on its underside and at least one fiducial marker secured to its upper side, the fiducial marker comprising a radiopaque core having an infrared reflective coating, the imaging device being capable of being adhered to a surface of a patient; a processor disposed in signal communication with the stereoscopic computer vision system and the computed tomography scanner, the processor configured to correlate the virtual space with the physical space using the fiducial marker as a single shared correspondence location; a display configured to display such correlation space in real time as a navigation aid for image-guided medical procedures; Equipped with.

[0023] In one embodiment, the system includes a medical device for use in an image-guided medical procedure, the device configured to be detected by a stereoscopic computer vision system and displayed on a display within such correlation space, i.e., equipped with an infrared reflective coating or the like.

[0024] According to a third aspect of the present invention, there is provided a medical image diagnostic method, the method comprising: adhering at least one medical imaging device to a surface of a patient, the medical imaging device comprising a flexible skin patch having an adhesive layer on an underside and at least one fiducial marker affixed to an upper side, the fiducial marker comprising a radiopaque core having an infrared reflective coating; performing a CT scan on a patient via a computed tomography scanner to generate a virtual space of the patient; monitoring a physical space near the patient via a stereoscopic computer vision system; correlating, via a processor, the virtual space and the physical space using the fiducial marker as a single corresponding location shared between the virtual space and the physical space as a real-time navigational aid for an image-guided medical procedure; Includes:

[0025] In one embodiment, adhering the medical imaging devices comprises adhering a plurality of devices to a surface of the patient.

[0026] In one embodiment, the method includes displaying such correlation space via a suitable display as a navigational aid for an image-guided medical procedure.

[0027] In one embodiment, the method includes detecting a medical instrument for use in an image-guided surgical procedure via a stereoscopic computer vision system and displaying the instrument within such correlation space.

[0028] According to a further aspect of the present invention there is provided a medical imaging apparatus, a medical imaging system, and an associated medical imaging method substantially as described and / or illustrated herein.

[0029] The description will be made with reference to the accompanying drawings. [Brief explanation of the drawings]

[0030] [Figure 1]1 is a schematic perspective view illustrating an embodiment of a medical imaging diagnostic apparatus according to an aspect of the present invention; [Figure 2] FIG. 2 is a schematic cross-sectional side view of the medical image diagnostic apparatus of FIG. 1. [Figure 3] 1 is a schematic perspective view of a medical imaging diagnostic system according to one aspect of the present invention; [Figure 4] 1 is a schematic top view illustrating an example of an embodiment of a medical imaging diagnostic device applied to the skin of a patient. DETAILED DESCRIPTION OF THE INVENTION

[0031] Further features of the present invention are more fully described in the following description of several non-limiting embodiments thereof. This description is provided solely for the purpose of illustrating the invention to those skilled in the art. It should not be understood as limiting the broad summary, disclosure, or description of the invention set forth above.

[0032] In the drawings incorporated to illustrate features of the exemplary embodiments, like reference numerals are used to identify like parts throughout. Additionally, features, features, and aspects that are well known and understood in the art will not be described in detail as such features, features, and aspects are within the understanding of those skilled in the art.

[0033] Additionally, the accompanying figures do not represent engineering or design drawings, but rather provide only a functional overview of the invention. As a result, necessary features and practical structural details of various embodiments may not be shown in the figures, although such structural requirements would be within the understanding of one of ordinary skill in the art.

[0034] Generally, the present invention provides medical imaging devices, systems, and related methods that facilitate non-invasive correlation or registration of anatomical landmarks through pre- and / or intra-operative imaging during image-guided surgical or related medical procedures.

[0035] Referring now to the accompanying drawings, there is shown one possible embodiment of such a medical imaging diagnostic device 10. The device 10 generally comprises a flexible skin patch 12 including an adhesive layer 14 on an underside or one side 16 and at least one fiducial marker 18 secured to an upper or opposite side 20 of the skin patch 12. The flexible skin patch 12 is generally a relatively small bandage, adhesive plaster, or skin dressing that can be removably adhered to the skin 26 of a patient 34. Accordingly, the skin patch 12 can take on a variety of shapes and sizes as desired, and such variations are expressly included herein.

[0036] In one embodiment, the flexible skin patch 12 is made from a woven fabric, a polymer such as PVC, polyethylene, or polyurethane, or latex. In one embodiment, the adhesive layer 14 comprises an acrylate, such as methacrylate and epoxy diacrylate. Of course, variations in this regard are possible and anticipated. The skin patch 12 may also include additional layers and / or coatings, such as a fluid-impermeable or fluid-resistant coating.

[0037] Importantly, as more clearly shown in FIG. 2 , fiducial marker 18 generally includes a radiopaque core 22 and an infrared-reflective coating or covering 24. The radiopaque core is detectable via a first imaging modality, and the infrared-reflective coating is detectable via a second imaging modality, the first and second imaging modalities operating in different electromagnetic spectrums. For example, in a typical embodiment, the first imaging modality includes computed tomography, or CT, scanning, and the second imaging modality includes stereoscopic computer vision, or the like. However, because fiducial marker 18 is a single object in space that is detectable via different imaging modalities, it can function as a single location or point shared between virtual and physical space, where virtual space can be defined via a CT scan that can reveal internal anatomical features, and physical space can be defined as visually identifiable external anatomical features that are readily visible to medical personnel.

[0038] Those skilled in the art will appreciate that different embodiments of the device 10 may include different numbers of fiducial markers 18 secured to the skin patch 12. Similarly, multiple fiducial markers 18 on a single skin patch 12 may be arranged in predetermined orientations and / or positions relative to one another, e.g., a known triangular orientation, a known number of markers 18 arranged in a row with known spacing, etc. In one embodiment, the medical imaging diagnostic device 10 comprises an array of fiducial markers 18 arranged in a predetermined manner.

[0039] The radiopaque core 22 can take a variety of forms, as is commonly understood in the art. For example, a radiopaque material having appropriate radiopacity appropriate for the desired spectrum can be used so that it is easily detected by x-ray without obscuring internal organs or causing excessive shadowing in x-ray imaging modalities. Thus, radiopacity should not be construed as absolute, but rather as including a "degree" of opacity to electromagnetic radiation in the desired spectrum.

[0040] Similarly, the reflective coating or covering 24 can be configured to reflect other frequency spectrums as desired, and can be achieved in several ways. For example, a reflective coating containing appropriate pigments and / or spectrally appropriate reflective compounds, such as the visible light spectrum, can be applied over the radiopaque core 22. Alternatively, in one embodiment, the fiducial marker 18 can be fabricated from a radiopaque material that is also reflective in infrared or other spectrums, such as a metal such as gold.

[0041] It should further be understood that fiducial marker 18 can take a variety of forms. For example, any manner of radiopaque core 22 with a reflective coating or covering 24 is suitable, so long as fiducial marker 18 forms a single shared location or point in space that is detectable by the first and second imaging modalities, as described herein. Thus, the shape of fiducial marker 18 and the materials used are not limited.

[0042] In this manner, the skin patch 12 can be removably adhered to the skin 26 of the patient 24, and the fiducial marker 18 can be detected as a single location or point in space via both stereoscopic computer vision 28 and computed tomography 30 imaging modalities, enabling correlation of virtual and physical space as a navigation aid for image-guided surgical procedures. As described, such virtual space generally refers to the three-dimensional space established via the computed tomography, or CT scan, imaging modality, and the physical space refers to the three-dimensional space established via the stereoscopic computer vision 28 modality. For example, in the described method, the radiopaque core 22 and coating 24 are approximately concentrically arranged spheres whose common center of gravity occupies a single location in space, such that the fiducial marker 18 can be detected as a single location or point in space.

[0043] In one embodiment, fiducial marker 18 is detectable as a shared, single location in space by having a shared or corresponding center for each of the spherical layers, i.e., core 22 and coating 24. One example of detecting such a shared, single location in space is via respective detection by first and second imaging modalities, as described, and a suitable image processing computing system having software instructions configured to consider such shared center location as an origin in a Cartesian coordinate system or the like. For example, such software may consider the dually detected fiducial markers, i.e., each component of core 22 and coating 24, as circles or spheres that can be juxtaposed or superimposed to determine a center point or location, or at least a common portion that can serve as an origin, or the like. Variations in this regard are possible, anticipated, and expressly included in this disclosure.

[0044] The present invention further includes an associated medical imaging diagnostic system 32, one possible embodiment of which is illustrated in Figure 3. Such a system 32 generally includes a stereoscopic computer vision system 28 configured to monitor a physical space near a patient 34, and a computed tomography scanner 30 configured to perform a CT scan to generate a virtual space of the patient 34. Such stereoscopic computer vision systems 28 and computed tomography scanners 30 are known in the art and will not be described in detail.

[0045] The system 32 also operatively includes at least one medical imaging device 10, as described above, which can be adhered to a surface of the patient 34, typically the skin 26, if desired. The system 32 further includes a suitable processor 36 disposed in signal communication with the stereoscopic computer vision system 28 and the computed tomography scanner 30, the processor 36 configured to correlate the virtual and physical spaces using the fiducial markers 18 as correspondences. In this manner, as described, the system 32 can correlate or register pre-operative imaging in the virtual space with anatomical landmarks in the physical space.

[0046] The system 32 also typically includes a suitable display 38 disposed in signal communication with the processor 26 and configured to display such correlation space as a navigational aid for an image-guided medical procedure. Thus, the system 32 can display the alignment of the virtual and physical spaces, often in real time, to guide a physician when performing a medical procedure.

[0047] Typically, the system 32 includes a medical device 40 for use in an image-guided medical procedure, the device including an infrared (or other spectral) reflective coating that is detected by the stereoscopic computer vision system 28 and displayed on the display 38 within such correlation space. The medical device 40 may also be detectable by the computed tomography scanner 30 and displayed on the display 38 within such correlation space, i.e., within the alignment between physical and virtual space.

[0048] Those skilled in the art will appreciate that the present invention further includes a related medical imaging method, including the steps of adhering at least one medical imaging device 10 to the surface of a patient 34, performing a CT scan on the patient via a computed tomography scanner 30 to generate a virtual space of the patient, monitoring a physical space near the patient via a stereoscopic computer vision system 28, and correlating the virtual space with the physical space via a processor 36 using the fiducial markers 18 as corresponding locations as a navigation aid for an image-guided medical procedure.

[0049] In one embodiment, adhering the medical imaging device 10 includes adhering multiple devices 10 to the surface of the patient 34. In one embodiment, multiple imaging devices 10 are adhered to the patient 34 in a predetermined or desired manner depending on the medical procedure to be performed. For example, as shown in FIG. 4 , in one embodiment, the adhesive layer 14 may include a strip having multiple fiducial markers 18, e.g., ten, disposed therealong, with two such strips 14 adhered perpendicular to each other on the patient, i.e., representing an x / y graph of the markers 18 at the desired locations.

[0050] Typically, the method includes displaying such correlation space as a navigation aid for the image-guided medical procedure via a suitable display 38. Additionally, the method typically includes detecting a medical device 40 for use in the image-guided medical procedure via a stereoscopic computer vision system 28 and a computed tomography scanner 30 and displaying the device within such correlation space.

[0051] Applicant believes that the present invention is particularly advantageous in that it provides a means of facilitating a reduction in the overall duration of a surgical or related medical procedure by improving precision and accuracy in applying medical device 40 to a desired location within a patient, and an associated reduction in radiation exposure due to the fewer CT passes required when assessing location during such image-guided surgical or related medical procedures. Similarly, the fact that fiducial markers 18 are detectable via different imaging modalities but occupy a single shared location in space facilitates correlation between virtual and physical spaces without requiring intensive computing power, as well as real-time display of such correlation as a navigation aid for image-guided medical procedures.

[0052] As a result, accurate, real-time medical guidance is achieved when performing minor surgical procedures such as injections by simply applying the medical imaging diagnostic device 10 to the patient, without the need for various X-ray or similar scans of the patient, and without the use of sophisticated operating tables or patient positioning structures. This results in improved patient comfort, allowing both the patient and medical personnel some freedom of movement during minor medical procedures such as injections without adverse effects.

[0053] Optional embodiments of the present invention may be broadly described as consisting of any or all combinations of two or more of the parts, elements, and features, individually or collectively, referred to or shown in this specification, and where specific components having known equivalents in the technical field to which the present invention pertains are referred to herein, such known equivalents are deemed to be incorporated herein as if individually set forth. In the illustrative embodiments, well-known processes, well-known device structures, and well-known techniques are not described in detail, as they will be readily apparent to those skilled in the art.

[0054] The use of the terms "a," "an," "said," "the," and / or similar reference words in the context of describing various embodiments (particularly in the context of claimed subject matter) is to be construed to cover both the singular and the plural unless stated otherwise herein or clearly contradicted by context. The terms "comprising," "having," "including," and "containing" are to be construed as open-ended terms (i.e., meaning "including, but not limited to") unless otherwise indicated. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0055] References herein to "one example" or "one example" of the invention or similar exemplary language (e.g., "such as") should not be understood to be made in an exclusive sense. Thus, one example illustrates a particular aspect of the invention, while other aspects may be exemplified by different examples. These examples are intended to aid those skilled in the art in practicing the invention, and are not intended to limit the overall scope of the invention unless the context clearly indicates otherwise.

[0056] Variations (e.g., modifications and / or enhancements) of one or more of the embodiments described herein will become apparent to those skilled in the art upon reading this application. The inventors expect that such variations will be adopted by those skilled in the art as appropriate, and intend that the claimed subject matter may be embodied in forms other than those specifically described herein.

[0057] The method steps, processes, and operations described herein should not be construed as necessarily requiring execution in the particular order described or illustrated, unless specifically indicated as such, and it will be understood that additional or alternative steps may be employed.

Claims

1. a flexible skin patch having an adhesive layer on the underside so as to be removably adhered to the skin in use; at least one fiducial marker secured to an upper side of the skin patch, i. a radiopaque core detectable via a first imaging modality; and ii. An infrared reflective coating detectable via a second imaging modality and a fiducial marker including the fiducial marker is detectable as a shared single location in space via both first and second imaging modalities to enable real-time correlation of virtual and physical spaces as a navigation aid for image-guided medical procedures; Medical imaging diagnostic equipment.

2. The medical imaging system of claim 1 , wherein the first imaging modality comprises computed tomography.

3. The medical imaging diagnostic system of claim 1 , wherein the second imaging modality comprises stereoscopic computer vision.

4. 4. The medical imaging diagnostic device of claim 1, wherein the flexible skin patch is made from a woven fabric, a polymer, polyethylene, polyurethane, or latex.

5. The medical imaging diagnostic device according to claim 1 , wherein the adhesive layer comprises an acrylate, such as a methacrylate or an epoxy diacrylate.

6. The medical imaging diagnostic device of claim 1 , wherein the fiducial markers are fabricated from a radiopaque material that is also infrared reflective.

7. a stereoscopic computer vision system configured to monitor a physical space near the patient; a computed tomography scanner configured to perform a CT scan to generate a virtual space of the patient; at least one medical imaging device comprising a flexible skin patch having an adhesive layer on an underside thereof and at least one fiducial marker secured to an upper side thereof, the fiducial marker comprising a radiopaque core having an infrared reflective coating, the imaging device being capable of being adhered to a surface of the patient; a processor disposed in signal communication with the stereoscopic computer vision system and the computed tomography scanner, the processor configured to correlate the virtual space with the physical space using the fiducial marker as a single shared correspondence; a display configured to display such correlation space in real time as a navigation aid for image-guided medical procedures; A medical image diagnostic system comprising:

8. 9. The medical imaging diagnostic system of claim 8, including a medical device for use in the image-guided medical procedure, the device configured to be detected by the stereoscopic computer vision system and displayed on the display within such correlation space.

9. adhering at least one medical imaging device to a surface of a patient, the medical imaging device comprising a flexible skin patch having an adhesive layer on an underside thereof and at least one fiducial marker affixed to an upper side thereof, the fiducial marker comprising a radiopaque core having an infrared reflective coating; performing a CT scan on the patient via a computed tomography scanner to generate a virtual space of the patient; monitoring a physical space near the patient via a stereoscopic computer vision system; correlating, via a processor, the virtual space and the physical space using the fiducial marker as a single corresponding location shared between the virtual space and the physical space as a real-time navigational aid for an image-guided medical procedure; A medical image diagnostic method comprising:

10. The method of claim 9 , wherein the step of adhering the medical imaging device comprises adhering a plurality of devices to the surface of the patient.

11. 11. The method of claim 9, further comprising displaying such correlation space in real time via a suitable display as a navigation aid for the image-guided medical procedure.

12. 12. The method of any one of claims 9 to 11, comprising detecting a medical instrument for use in the image-guided surgical procedure via the stereoscopic computer vision system and displaying the instrument within such correlation space.

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