Systems and methods for anatomical feature determination
By analyzing images before and after the procedure to identify the location of mineral deposits, the problem of natural leaflets obstructing the coronary artery access after prosthetic valve implantation was solved, achieving accurate coronary artery access estimation and improving the success rate of the operation.
Patent Information
- Application Number
- CN202511135785.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2020-02-04
- Filing Date
- 2021-02-02
- Publication Date
- 2025-11-07
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Figure CN120899432A_ABST
Abstract
Description
[0001] This application is a divisional application of the original application with a filing date of February 2, 2021, application number 202180012532.5, entitled “SYSTEMS AND METHODS FOR ANATOMICAL FEATURE DETERMINATION”, the entirety of which is incorporated herein by reference.
[0002] Cross Reference to Related Applications
[0003] This application claims priority to U.S. Provisional Application No. 62 / 970,110, filed February 4, 2020, entitled “SYSTEMS AND METHODS FOR ANATOMICAL FEATURE DETERMINATION”, the entirety of which is incorporated herein by reference. TECHNICAL FIELD
[0004] The present disclosure relates to the field of medical devices and procedures. BACKGROUND
[0005] Aortic valve calcification occurs when calcium deposits form on the aortic valve of the heart. The calcium deposits can cause the aortic valve to narrow and / or harden at the opening. When calcification is severe, the aortic valve cannot open and close properly, affecting blood flow through the valve, a condition known as aortic valve stenosis. Certain cases of aortic valve calcification or stenosis require replacement of the aortic valve with a prosthetic valve. SUMMARY
[0006] Described herein are one or more methods and / or systems for anatomical feature determination. In some aspects, the present disclosure relates to methods and systems for determining access for anatomical features based on analysis of one or more images showing mineral deposits.
[0007] In some embodiments, the present disclosure relates to a method for determining a location of a native leaflet. The method can include obtaining a pre-procedural image showing a native valve within a heart vessel and analyzing the pre-procedural image to determine a location of mineral deposits on a native leaflet of the native valve. The method can also include obtaining, by a control circuit, a post-procedural image showing a prosthetic valve implanted at the native valve and analyzing the post-procedural image to identify a location of mineral deposits within the heart vessel. Further, the method can include determining, by the control circuit, a location of the native leaflet within the heart vessel. The location of the native leaflet can be determined based at least in part on the location of the mineral deposits on the native leaflet and the location of the mineral deposits within the heart vessel. In some implementations, the native valve comprises an aortic valve and the heart vessel comprises an aorta.
[0008] In some embodiments, the method further includes determining access to a fluid vessel associated with the heart vessel based at least in part on the location of the native leaflet within the heart vessel. In some implementations, the method further includes identifying a location of at least a portion of the endoprosthetic valve within the heart vessel based at least in part on the analysis of the post-procedure image. The determination of the access to the fluid vessel can be based at least in part on the location of the at least a portion of the endoprosthetic valve within the heart vessel. Further, in some implementations, the method further includes identifying a location of a coaptation leaflet within the heart vessel based at least in part on the analysis of the pre-procedure image; determining a distal end of the native leaflet based at least in part on the location of the coaptation leaflet; and determining a distance between the distal end of the native leaflet and the mineral deposit. The determination of the access to the fluid vessel can be based at least in part on the distance between the distal end of the native leaflet and the mineral deposit.
[0009] In some embodiments, the analysis of the pre-procedure image to identify a location of a mineral deposit on the native leaflet can include generating user interface data that presents the pre-procedure image; providing the user interface data to a display device; receiving an input regarding the mineral deposit; and identifying the location of the mineral deposit based at least in part on the input. Further, in some embodiments, the analysis of the pre-procedure image to identify a location of a mineral deposit on the native leaflet can include performing one or more image processing techniques on the pre-procedure image to identify the location of the mineral deposit on the native leaflet.
[0010] In some implementations, the present disclosure is directed to a computing system including a control circuit and a memory communicatively coupled to the control circuit and storing executable instructions that, when executed by the control circuit, cause the control circuit to perform operations. The operations can include receiving data indicative of a location of a mineral formation on a native leaflet of a native valve within a heart vessel; generating graphical interface data that presents an image of an endoprosthetic valve implanted at the native valve; receiving an input regarding a location of a mineral presentation in the image; and determining a location of the native leaflet within the heart vessel based at least in part on the input and the data. In some implementations, the image includes at least one of a computed tomography image or an x-ray image of the heart vessel.
[0011] In some embodiments, the native valve includes an aortic valve and the heart vessel includes an aorta. In some implementations, the operations further include determining an amount of access to a coronary artery based at least in part on the location of the native leaflet within the heart vessel. Further, in some implementations, the operations further include identifying a location of at least a portion of the endoprosthetic valve within the aorta. The determination of the amount of access to the coronary artery can be based at least in part on the location of the at least a portion of the endoprosthetic valve within the aorta.
[0012] In some embodiments, the data indicates a location of the mineral formation relative to a tip of the native leaflet, and determining the location of the native leaflet within the heart vessel is based at least in part on the location of the mineral formation relative to the tip of the native leaflet. Further, in some embodiments, the data indicates one or more characteristics of the mineral formation, and the operations further include, based at least in part on the data, performing one or more image processing techniques on the image to determine that the mineral formation in the image exhibits mineral formation on the native leaflet.
[0013] In some implementations, the disclosure relates to a method that includes obtaining, by a control circuit, an image exhibiting a prosthetic valve implanted at a native valve within a heart vessel and receiving, by the control circuit, data indicating a location of mineral formation on a native leaflet prior to implantation of the prosthetic valve. The method can further include analyzing the image to identify a location of the mineral formation within the heart vessel and determining a location of the native leaflet within the heart vessel based at least in part on the location of the mineral formation and the data.
[0014] In some implementations, the method further includes determining an amount of access to a fluid vessel associated with the heart vessel based at least in part on the location of the native leaflet within the heart vessel. In some implementations, the method further includes identifying a location of at least a portion of the prosthetic valve within the heart vessel. Determining the amount of access to the fluid vessel can be based at least in part on the location of the at least a portion of the prosthetic valve within the heart vessel. Further, in some implementations, the method further includes identifying a location of a coaptation leaflet within the heart vessel, determining a tip of the native leaflet based at least in part on the location of the coaptation leaflet, and determining a distance between the tip of the native leaflet and the mineral formation. Determining the amount of access to the fluid vessel can be based at least in part on the distance between the tip of the native leaflet and the mineral formation.
[0015] In some embodiments, the data indicates a location of the mineral formation relative to a tip of the native leaflet. Determining the location of the native leaflet within the heart vessel can be based at least in part on the location of the mineral formation relative to the tip of the native leaflet. Further, in some embodiments, analyzing the image to identify a location of the mineral formation within the heart vessel includes performing one or more image processing techniques on the image to identify the location of the mineral formation within the heart vessel.
[0016] In some implementations, the disclosure relates to a method that includes analyzing a first image to determine a location of mineral deposits on native leaflets within a heart vasculature and analyzing a second image to determine a location of mineral deposits within the heart vasculature. The first image can depict a native valve and the second image can depict a prosthetic valve. The method can also include determining an approach to a coronary artery based at least in part on the location of mineral deposits on the native leaflets and the location of mineral deposits within the heart vasculature and providing an indication indicative of a condition of the approach to the coronary artery. The indication can be based at least in part on the determined approach to the coronary artery. In some implementations, the indication is indicative of a risk level associated with performing a procedure that includes accessing the coronary artery.
[0017] In some implementations, the indication is indicative of an amount of the approach to the coronary artery. In some implementations, the method further includes determining that the amount of the approach to the coronary artery is less than a threshold and refraining from performing a procedure that includes accessing the coronary artery based at least in part on determining that the amount of the approach to the coronary artery is less than the threshold. Further, in some implementations, the method further includes determining that the amount of the approach to the coronary artery is greater than a threshold and performing a procedure that includes accessing the coronary artery based at least in part on determining that the amount of the approach to the coronary artery is greater than the threshold.
[0018] For purposes of summarizing the disclosure, certain aspects, advantages and novel features are described. It is to be understood that not necessarily all such advantages can be achieved in accordance with any particular embodiment. Thus, embodiments disclosed can be executed in a manner that achieves or optimizes one advantage or a limited number of advantages as taught herein without necessarily achieving other advantages as can be taught or implied by other embodiments. BRIEF DESCRIPTION OF DRAWINGS
[0019] Various implementations are depicted in the drawings and are by no means intended to limit the scope of the present disclosure. Further, various features of different disclosed implementations can be combined to form further implementations that are part of the present disclosure. Throughout the drawings, reference numbers can be re-used to indicate correspondence between referenced elements.
[0020] FIG. 1 A perspective view of an example heart is illustrated in accordance with one or more implementations.
[0021] FIG. 2 A cross-sectional top view of an example heart is illustrated in accordance with one or more implementations.
[0022] FIG. 3 A cross-sectional view of an example heart with mineral formation on an aortic valve is illustrated in accordance with one or more implementations.
[0023] FIG. 4An example of a cross-sectional view of a heart with a prosthetic valve implanted at the aortic valve is illustrated in accordance with one or more embodiments. FIG. 3 An example cross-sectional view of a heart with a prosthetic valve implanted at the aortic valve.
[0024] FIG. 5 An example architecture for determining access to an anatomical feature based on analysis of one or more images showing mineral deposits is illustrated in accordance with one or more embodiments.
[0025] FIG. 6 An example cross-sectional view of an example native leaflet and mineral formation is illustrated in accordance with one or more embodiments.
[0026] FIG. 7 An example cross-sectional view of an example native leaflet, mineral formation, and prosthetic valve is illustrated in accordance with one or more embodiments.
[0027] FIG. 8A-8B An example flowchart of a process for analyzing one or more images to determine a location / characteristic of an anatomical feature is illustrated in accordance with one or more embodiments.
[0028] FIG. 9 An example flowchart of a process for providing an interface to determine a location / characteristic of an anatomical feature is illustrated in accordance with one or more embodiments.
[0029] FIG. 10 An example image of a heart vasculature prior to implantation of a prosthetic valve is illustrated in accordance with one or more embodiments.
[0030] FIG. 11 An example image of a heart vasculature after implantation of a prosthetic valve is illustrated in accordance with one or more embodiments. DETAILED DESCRIPTION
[0031] The headings provided herein are merely for convenience and do not necessarily affect the scope or meaning of the claimed subject matter. This disclosure relates to systems, devices, and methods for determining access to an anatomical feature based on analysis of one or more images showing mineral deposits.
[0032] While certain preferred embodiments and examples are disclosed herein, the subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and to modifications and equivalents of the embodiments and examples disclosed. It is intended that the scope of the following claims include all such alternatives. For example, in any method or process disclosed herein, the acts or operations can be performed in any suitable order where appropriate. The descriptions, aspects and advantages of certain embodiments and examples follow. It is not intended that any one or more of these aspects or advantages be relied upon as a prerequisite to any patentability, issued or pending, nor that the scope of any patent be determined by any such aspect or advantage. Various implementations of the subject matter, as described, can be realized. The disclosed subject matter can be implemented by realizing various aspects or features of the implementations. Accordingly, various aspects of the implementations have been described above.
[0033] The term "associated with" is used herein according to its broad and ordinary meaning. For example, where a first feature, element, component, device, or member is described as "associated with" a second feature, element, component, device, or member, such description is to be understood to indicate that the first feature, element, component, device, or member is physically coupled, attached, or connected with the second feature, element, component, device, or member, is integral therewith, is at least partially embedded therein, or is otherwise physically related thereto, whether directly or indirectly.
[0034] SUMMARY
[0035] As mentioned above, some cases of aortic valve calcification or stenosis require replacement of the aortic valve with a prosthetic valve. Prosthetic heart valve implantation can involve delivering the prosthetic valve to the natural valve and deploying it against the valve and / or surrounding anatomy. For example, when a prosthetic valve is implanted at the aortic valve, the natural leaflets of the valve are displaced toward the aortic wall and surrounding anatomy. In some cases, one or more of the natural leaflets may completely or partially obstruct the coronary ostium, thus blocking access to the coronary arteries. In the future, access to the coronary arteries may be required to perform other procedures on the heart or surrounding anatomy (sometimes called "re-access procedures"). For example, in some re-access procedures, a physician may navigate a device such as an endoscope or catheter through the aorta to the aortic valve and attempt to reach the coronary arteries through the coronary ostium. However, the physician may not be aware of the extent to which the natural leaflets have been displaced by the prosthetic valve to the degree to which the natural leaflets are obstructing access to the coronary arteries. Such blocking may result in unsuccessful re-access procedures and / or failures when executing re-access procedures because they might have succeeded.
[0036] This disclosure describes techniques and systems for determining access to anatomical features based on the analysis of one or more images displaying mineral deposits. In some embodiments, the techniques can estimate the location of the natural valve after implantation of a prosthetic valve. For example, the techniques can analyze pre-procedural images of the natural valve to determine the location of mineral deposits on the natural leaflet, such as calcium deposits. After implantation of the prosthetic valve, the techniques can analyze post-procedural images of the prosthetic valve to identify the location of mineral deposits within the heart valve region. Based on the location of mineral deposits on the natural leaflet (determined from the pre-procedural images) and the location of mineral deposits within the heart valve region (identified from the post-procedural images), the techniques can estimate the location of the natural leaflet after prosthetic valve implantation. Such information can be used to determine the amount of access (e.g., available space) to a blood vessel (such as a coronary artery) located near the natural valve.
[0037] In many embodiments, the techniques and systems described are discussed in the context of calcium and / or phosphate formation on the valves, such as in the case of aortic valve calcification / stenosis. However, these techniques and systems can be applied to a variety of contexts, such as other mineral and / or anatomical features.
[0038] Example heart anatomy
[0039] FIG. 1 and 2 An example heart 100 having various characteristics related to certain aspects of this disclosure is provided. Specifically, FIG. 1 An example of a 3D image of the heart (size 100) is shown, while FIG. 2A cross-sectional top view of a heart 100 is illustrated. The heart 100 includes four chambers, namely a left ventricle 102, a left atrium 104, a right ventricle 106, and a right atrium 108. A muscular wall, referred to as the septum, separates the left-side chambers from the right-side chambers. Specifically, an atrial septum wall portion separates the left atrium 104 from the right atrium 108, and a ventricular septum wall portion separates the left ventricle 102 from the right ventricle 106. The lower pointed end 110 of the heart 100 is referred to as the cardiac apex, and is generally located in the fifth intercostal space on or near the sternum.
[0040] The heart 100 includes four valves for assisting blood circulation therein. Heart valves can generally include a relatively dense ring of fibers (referred to herein as an annulus), and a plurality of leaflets or cusps attached to the annulus. Generally, the size and position of the leaflets or cusps can be such that when the heart contracts, and thus the increased blood pressure generated within the corresponding heart chamber forces the leaflets to at least partially open to allow flow from the heart chamber. As the pressure in the heart chamber subsides, the pressure in the subsequent chamber or vessel can become dominant and push back against the leaflets. As a result, the leaflets / cusps coapt with one another, thereby closing the flow passage.
[0041] Surrounding the ventricles (102, 106) are a plurality of arteries 112 (sometimes referred to as "coronary arteries 112") that supply oxygenated blood to the myocardium, and a plurality of veins (not shown) that return blood from the myocardium to the right atrium 108 via the coronary sinus, which is a relatively large vein that extends generally around the upper portion of the left ventricle 102 and provides a return conduit for blood to the right atrium 108.
[0042] The left ventricle 102 is the primary pumping chamber of the heart 100. A healthy left ventricle is generally conical or apical in shape, as it is longer (relative to the average electrical axis of the heart 100) than it is wide (relative to a transverse axis extending between opposing walls of the left ventricle 102, at its widest point), and tapers from a base 114 of reduced cross-sectional diameter and / or circumference down to a point or apex 110. Generally, the apical region of the heart 100 can be considered the bottom region of the heart 100, which is within the left ventricle region and / or the right ventricle region, but distal to the mitral valve 202 and the tricuspid valve 204 and arranged toward the apex 110 of the heart.
[0043] Pumping blood from the left ventricle 102 is accomplished by a squeezing motion and a twisting or torsional motion. The squeezing motion occurs between the lateral wall and the septum of the left ventricle 102. The twisting motion is a result of the contraction of the myocardial fibers that run in a generally circular or spiral direction around the heart 100. When these fibers contract, they produce a gradient of angular displacement of the myocardium around the mean electrical axis of the heart 100, from the apex 110 to the base 114. The resultant vector extends at an angle of about 30-60 degrees to the blood flow through the aortic valve 208 and ascending aorta 116. When viewed from the apex 110 (i.e., an inferior view of the heart 100), the contraction of the heart 100 appears as a counterclockwise rotation of the apex 110 relative to the base 114. The contraction of the heart 100, in combination with the filling volumes of the left atrium 104 and left ventricle 102, respectively, results in relatively high fluid pressures on the left side of the heart 100 at least during certain phases of the cardiac cycle.
[0044] The primary role of the chambers on the left side of the heart 100 (i.e., the left atrium 104 and the left ventricle 102) is to act as a holding chamber for blood returning from the lungs (not shown) and as a pump that carries blood to other areas of the heart 100. The left atrium 104 receives oxygenated blood from the lungs through the pulmonary veins. The oxygenated blood collected in the left atrium 104 from the pulmonary veins enters the left ventricle 102 through the mitral valve 202. In some patients, the walls of the left atrium 104 are slightly thicker than the walls of the right atrium 108. Deoxygenated blood enters the right atrium 108 through the inferior vena cava 118 and the superior vena cava 120. The right side of the heart 100 (i.e., the right atrium 108 and the right ventricle 106) then pumps this deoxygenated blood into the pulmonary artery 120 that surrounds the lungs. There, fresh oxygen enters the blood stream, and the blood moves to the left side of the heart 100 through the network of pulmonary veins that ultimately terminate in the left atrium 104. In FIG. 1 In the middle, the portion of the pulmonary trunk is removed (i.e., shown in dashed lines) to expose the left coronary artery 112 (A).
[0045] The valves of the heart 100 include the tricuspid valve 204 that separates the right atrium 108 from the right ventricle 106. The tricuspid valve 204 can generally have three cusps or leaflets and can generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The valves of the heart 100 also include the pulmonary valve 206 that separates the right ventricle 106 from the pulmonary artery 120 and can be configured to open during systole so that blood can be pumped to the lungs and to close during diastole to prevent blood from leaking back from the pulmonary artery 120 to the heart 100. The pulmonary valve 206 generally has three cusps / leaflets, each of which can have a crescent shape. The heart 100 also includes the mitral valve 202 that generally has two cusps / leaflets and separates the left atrium 104 from the left ventricle 102. The mitral valve 202 can generally be configured to open during diastole so that blood in the left atrium 104 can flow into the left ventricle 102 and to close during diastole to prevent blood from leaking back to the left atrium 104. Further, the heart 100 includes the aortic valve 208 that separates the left ventricle 102 from the aorta 116. The aortic valve 208 generally has three cusps / leaflets, each of which can have a crescent shape. The aortic valve 208 is configured to open during systole to allow blood to exit the left ventricle 102 into the aorta 116 and to close during diastole to prevent blood from leaking back to the left ventricle 102.
[0046] The atrioventricular (i.e., mitral and tricuspid) heart valves are generally associated with a sub-valvular apparatus that includes a collection of chordae tendinae and papillary muscles that secure the leaflets of the respective valves to promote and / or facilitate proper coaptation of the valve leaflets and prevent prolapse thereof. The papillary muscles can generally include finger-like projections that originate from the walls of the ventricles, for example. The chordae tendinae generally prevent the leaflets from opening in the wrong direction, thereby preventing blood from flowing back to the left atrium 104.
[0047] With further reference to the aortic anatomy of the heart 100, the ascending aorta generally originates at the opening of the aortic valve 208 in the left ventricle 102 of the heart. The ascending aorta can pass through a common pericardial sheath with the pulmonary trunk. At the root of the ascending aorta, the blood cavity can generally present three relatively small pockets between the cusps of the aortic valve 208 and the wall of the aorta 116 (i.e., aortic sinuses or "Vasa Vasorum"). The left aortic sinus contains the origin of the left coronary artery 112(A) (also referred to as "LCA 112(A)"), while the right aortic sinus likewise produces the right coronary artery 112(B) (also referred to as "RCA 112(B)"). The posterior aortic sinus does not produce a coronary artery.
[0048] FIG. 2Various features associated with the coronary arteries 112 are shown. As described above, the left coronary artery 112(A) and the right coronary artery 112(B) originate in the aortic sinus. The left coronary artery 112(A) originates above the left cusp 208(A) (also referred to as the “left leaflet 208(A)”) of the aortic valve 208, while the right coronary artery 112(B) originates above the right cusp 208(B) (also referred to as the “right leaflet 208(B)”) of the aortic valve 208. The root of the aorta 116 includes coronary orifices 210 where the coronary arteries 112 connect, with the left coronary orifice 210(A) being located above the left cusp 208(A) and the right coronary orifice 210(B) being located above the right cusp 208(B).
[0049] Example aortic valve calcification and prosthetic valve
[0050] FIG. 3 and 4 A cross-sectional view of a heart 100 with mineral formation on the aortic valve 208 is illustrated in accordance with one or more embodiments. As used herein, the term “mineral formation” or “mineral deposits” can generally refer to one or more minerals that are embedded and / or attached to an anatomical feature. For example, in FIG. 3 and 4 calcium and / or phosphate is embedded and / or attached to the aortic valve 208, such as on / within the leaflets of the aortic valve 208. Although many example embodiments are discussed in the context of calcium and / or phosphate formation on the aortic valve, other types of mineral formation can occur on the aortic valve and / or other valves / anatomical features.
[0051] In the examples of FIG. 3 and 4 the aortic valve 208 includes relatively severe calcification (e.g., aortic stenosis) that requires replacement with a prosthetic valve 402 FIG. 4The native leaflets of the aortic valve 208 can limit access to the coronary arteries (not shown in FIG. 1) when the native leaflets are displaced toward the aortic wall. That is, the native leaflets can obstruct access from the aorta 116 to the coronary arteries 112 via the coronary ostia 210.
[0052] In any case, when the prosthetic valve 402 is implanted, the leaflets of the aortic valve 208 can be displaced toward the aortic wall, as shown in FIG. 2. For example, the prosthetic valve 402 can radially expand and press the leaflets of the aortic valve 208 toward the aortic wall. In other words, the size / diameter of the prosthetic valve 402 can change to provide an outward radial force and displace the leaflets of the aortic valve 208 toward the aortic wall. Once implanted, the prosthetic valve 402 can continue to provide the outward radial force and maintain the leaflets of the aortic valve 208 in the position shown in FIG. 2. In certain cases, when the native leaflets of the aortic valve 208 are displaced toward the aortic wall, the native leaflets can limit access to the coronary arteries (not shown in FIG. 2). That is, the native leaflets can obstruct access from the aorta 116 to the coronary arteries 112 via the coronary ostia 210. FIG. 4 FIG. 4 In certain cases, when the native leaflets of the aortic valve 208 are displaced toward the aortic wall, the native leaflets can limit access to the coronary arteries (not shown in FIG. 2). That is, the native leaflets can obstruct access from the aorta 116 to the coronary arteries 112 via the coronary ostia 210. FIG. 3 4 In certain cases, when the native leaflets of the aortic valve 208 are displaced toward the aortic wall, the native leaflets can limit access to the coronary arteries (not shown in FIG. 2). That is, the native leaflets can obstruct access from the aorta 116 to the coronary arteries 112 via the coronary ostia 210.
[0053] The prosthetic valve 402 (sometimes referred to as an "artificial heart valve 402") can include various types of prosthetic valves, such as a catheter-based prosthetic valve (e.g., a transcatheter heart valve (THV)), a surgical prosthetic valve, etc. In some embodiments, the prosthetic valve 402 is configured to be radially compressed into a compressed state for delivery through the vasculature of a patient. Once positioned at a desired location within the vasculature of the patient, the prosthetic valve 402 can be configured to self-expand to a natural, uncompressed state or functional state having a pre-set diameter.
[0054] In some embodiments, the prosthetic valve 402 can include a support frame, which can include a lattice frame (e.g., a stent) configured to secure the prosthetic valve 402 within or near the defective annulus of the heart 100. The support stent structure can also provide stability and prevent migration of the prosthetic valve 402 after its implantation. The support stent structure can include any suitable or desired material, such as a memory metal, a metal alloy such as stainless steel or cobalt-chromium alloy, and / or a polymer. In addition, the support stent structure can have a different configuration than that shown. For example, the support stent structure can have a different shape, more or fewer vertical support struts, and / or other structures for improved stability. In certain embodiments, the support stent structure can include a strut web and / or a sleeve structure. FIG. 4
[0055] In some embodiments, the support stent structure can be secured to a valve leaflet assembly. The valve leaflet assembly can include a plurality of leaflets that collectively function as a one-way valve by coapting against one another. For example, for a prosthetic aortic valve, the valve leaflet assembly can include three leaflets. However, it should be understood that a prosthetic valve can have a greater or lesser number of leaflets. The various components of the valve leaflet assembly can be formed, in whole or in part, of any suitable biological material or polymer, such as polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), and the like.
[0056] Example architecture
[0057] FIG. 5 An example architecture 500 illustrating determining access to an anatomical feature based on analysis of one or more images showing mineral deposits in accordance with one or more embodiments is illustrated. The architecture 500 includes one or more imaging devices 502 (referred to for ease of discussion as "imaging devices 502") configured to capture / generate one or more images of a patient 504 and one or more computing systems 506 (referred to for ease of discussion as "computing systems 506") configured to evaluate the one or more images to determine access to an anatomical feature associated with the patient 502. The imaging devices 502 and the computing systems 506 can be configured to communicate over one or more networks 508, such as to send / receive data including the one or more images produced by the imaging devices 502 and / or any other data. The computing systems 506 can be configured to receive input from and / or provide output to a user, such as a physician, technician, radiologist, and the like.
[0058] In some embodiments, imaging device 502 can be configured to generate one or more pre-procedural images of patient 504 and provide the one or more pre-procedural images to computing system 506 prior to implantation of a prosthetic valve. Computing system 506 can interface with a physician or operate independently to determine a location / characteristic of one or more mineral formations on a native valve based on the one or more pre-procedural images. After or during implantation of the prosthetic valve, imaging device 502 can be configured to generate one or more procedural images or post-procedural images of patient 504 and provide the one or more procedural images or post-procedural images to computing system 506. Computing system 506 can interface with a physician or operate independently to identify a location of the one or more mineral formations within a heart vessel. Further, computing system 506 can use pre-procedural data indicative of a location of the one or more mineral formations to determine a location of a native valve within a heart vessel, which can be approximately a shifted location due to implantation of a prosthetic valve. Further, computing system 506 can determine a location of a prosthetic valve within a heart vessel. Based on the location of the native valve and / or the prosthetic valve, computing system 506 can determine an amount of space available to access a fluid vessel within a heart vessel, such as a coronary artery.
[0059] Although computing system 506 and imaging device 502 are discussed in many embodiments as performing both pre-procedural processing and post-procedural processing, computing system 506 and / or imaging device 502 can be implemented as one or more devices / systems that can perform pre-procedural processing and / or post-procedural processing. In some embodiments, a first computing system and / or imaging device can be used to perform pre-procedural processing, while a second computing system and / or imaging device can be used to perform post-procedural processing. Further, in some embodiments, imaging device 502 and computing system 506 are located in the same facility / environment / location, while in other embodiments, imaging device and computing system 506 are located in separate facilities / environments / locations.
[0060] The computing system 506 can be implemented as one or more computing devices, such as one or more desktop computers, laptop computers, servers, smartphones, e-reader devices, mobile handsets, personal digital assistants, portable navigation devices, portable gaming devices, tablet computers, wearable devices (e.g., watches, optical head-mounted displays, etc.), portable media players, televisions, set-top boxes, computer systems in vehicles, appliances, cameras, security systems, home computer systems, projectors, medical monitors, etc. In some implementations, the one or more computing devices are configured in a cluster, data center, cloud computing environment, or combination thereof. Moreover, in some implementations, the one or more computing devices are implemented as remote computing resources located remotely from the imaging device 502. In other implementations, the one or more computing devices are implemented as local resources located locally within the environment of the imaging device 502.
[0061] As shown, the computing system 506 can individually / independently and / or collectively / combinatorially include one or more of the following components, devices, modules, and / or units (referred to herein as "components"): control circuitry 510, one or more I / O components 512, one or more network interfaces 514, and / or data storage / memory 516. Although FIG. 5 Certain components of the computing system 506 are illustrated in FIG. 1, but it should be appreciated that other components not shown can also be included in implementations consistent with this disclosure. Moreover, certain components of the example can be omitted in some implementations. Although the control circuitry 510 is illustrated in the diagram of FIG. 1 as a single component, it should be appreciated that any or all of the remaining components of the computing system 506 can be at least partially embodied in the control circuitry 510. That is, the control circuitry 510 can include various devices (active and / or passive), semiconductor materials and / or domains, layers, regions, and / or portions thereof, conductors, leads, vias, connectors, and / or the like, in which one or more other components of the computing system 506 and / or portions thereof can be at least partially formed and / or embodied by. FIG. 5 Although the control circuitry 510 is illustrated in the diagram of FIG. 1 as a single component, it should be appreciated that any or all of the remaining components of the computing system 506 can be at least partially embodied in the control circuitry 510. That is, the control circuitry 510 can include various devices (active and / or passive), semiconductor materials and / or domains, layers, regions, and / or portions thereof, conductors, leads, vias, connectors, and / or the like, in which one or more other components of the computing system 506 and / or portions thereof can be at least partially formed and / or embodied by.
[0062] The various components of the computing system 506 can be electrically and / or communicatively coupled using certain connectivity circuitry / devices / features, which can or can not be part of the control circuitry 510. For example, the connectivity features can include one or more printed circuit boards configured to facilitate mounting and / or interconnection of at least some of the various components / circuitry of the computing system 506. In some embodiments, two or more of the control circuitry 510, the one or more I / O components 512, the one or more network interfaces 514, and / or the data storage / memory 516 can be electrically and / or communicatively coupled to one another.
[0063] The one or more I / O components 512 can include a number of components that receive input and / or provide output to, for example, interface with a user. The one or more I / O components 512 can be configured to receive touch, voice, gesture, or any other type of input. Further, the one or more I / O components 512 can be configured to output display data, audio data, haptic feedback data, or any other type of output data. The one or more I / O components 512 can include one or more displays (sometimes referred to as “one or more display devices”), touchscreens, touchpads, controllers, mice, keyboards, wearable devices (e.g., optical head-mounted displays), virtual or augmented reality devices (e.g., head-mounted displays), speakers (e.g., configured to output sound according to audio signals), microphones (e.g., configured to receive sound and generate audio signals), cameras, and the like. The one or more displays can include one or more liquid crystal displays (LCDs), light-emitting diode (LED) displays, organic LED displays, plasma displays, e-paper displays, and / or any other type(s) of technology. In some embodiments, the one or more displays include one or more touchscreens configured to receive input and / or display data.
[0064] The one or more network interfaces 514 can be configured to communicate with one or more devices / systems over the one or more networks 508. For example, the one or more network interfaces 514 can transmit / receive data, such as one or more images captured by the imaging device 502, over a network in a wireless and / or wired manner. The one or more networks 508 can include one or more local area networks (LANs), wide area networks (WANs) (e.g., the Internet), personal area networks (PANs), body area networks (BANs), and the like. In some embodiments, the one or more network interfaces 514 can implement wireless technologies such as Bluetooth, Wi-Fi, near-field communication (NFC), or similar technologies.
[0065] As shown, memory 516 can include feature determination component 518, graphical user interface component 520, and / or image processing component 522 configured to facilitate the various functionalities discussed herein. In some embodiments, one or more of components 518-522 can include and / or be implemented as one or more executable instructions that, when executed by control circuit 510, cause control circuit 510 to perform one or more operations. Although many embodiments are discussed in the context of components 518-522 including one or more instructions that are executable by control circuit 512, any of components 518-522 can be implemented at least partially as one or more hardware logic components, such as one or more application specific integrated circuits (ASICs), one or more field programmable gate arrays (FPGAs), one or more special-purpose programmable standard products (ASSPs), one or more complex programmable logic devices (CPLDs), and / or the like. Moreover, although components 518-522 are shown as being included within computing system 506, any of components 518-522 can be implemented at least partially within another device / system, such as imaging device 502 and / or another device / system. Similarly, any other components of computing system 506 can be implemented at least partially within another device / system.
[0066] The feature determination component 518 can be configured to identify one or more anatomical features and / or characteristics / locations of the one or more anatomical features. For example, the feature determination component 518 can evaluate one or more pre-procedural images captured by the imaging device 502 and / or stored in an image datastore 524. The one or more pre-procedural images can illustrate one or more features of the patient 504 prior to implanting a medical device in the patient 504, such as prior to implanting a prosthetic valve within a heart vessel. Evaluation of the one or more pre-procedural images can determine one or more characteristics / locations of one or more anatomical features within the patient 504. For example, the feature determination component 518 can determine characteristics / locations of native leaflets (e.g., locations of native leaflets within a heart vessel, lengths of leaflets, distances from tips of leaflets to a particular plane, based on locations of native leaflet tips of coapted leaflets, etc.), characteristics / locations of mineral deposits (e.g., locations of mineral deposits on native leaflets, sizes of mineral deposits, etc.), characteristics / locations of anatomical structures surrounding native leaflets (e.g., diameters of coronary arteries, diameters of the aorta, distances of coronary ostia from a valve annulus plane and basal plane, etc.), characteristics / locations of coapted leaflets (e.g., locations of coapted leaflets), etc. The feature determination component 518 can store data indicative of such characteristics / locations in an anatomical feature datastore 526 (sometimes referred to as “pre-procedural data”).
[0067] Further, the feature determination component 518 can evaluate one or more procedural images or post-procedural images captured by the imaging device 502 and / or stored in the image datastore 524. The one or more procedural images or post-procedural images can illustrate one or more features of the patient 504 while the medical device is being implanted in the patient 504 and / or after the medical device has been implanted, such as after a prosthetic valve is implanted within a heart vessel. Evaluation of the one or more procedural images or post-procedural images can determine one or more characteristics / locations of one or more anatomical features within the patient 504 during / after the procedure. For example, the feature determination component 518 can determine one or more characteristics / locations related to the aortic valve annulus / valve region, such as characteristics / locations of native leaflets during / after the procedure, characteristics / locations of mineral deposits on native leaflets during / after the procedure, characteristics / locations of anatomical structures surrounding native leaflets during / after the procedure, amounts of access to anatomical features during / after the procedure (e.g., amounts of access to coronary arteries), etc. The feature determination component 518 can store data indicative of such characteristics / locations in the anatomical feature datastore 526 (sometimes referred to as “procedural data” or “post-procedural data”).
[0068] In assessing one or more pre-procedure images or post-procedure images, the feature determination component 518 can reference data stored in the anatomical feature data store 526, such as pre-procedure data. For example, the feature determination component 518 can identify a calcium show in a post-procedure image and determine that the calcium show corresponds to a particular calcium deposit on a native leaflet based on pre-procedure data indicating a particular calcium deposit property (e.g., size of the calcium deposit). Further, the feature determination component 518 can also determine a location of the native leaflet within the heart vessel based on the pre-procedure data, which can indicate a location of the calcium deposit on the native leaflet, such as a distance from the end of the native leaflet to the calcium deposit. Further, the feature determination component 518 can determine an amount of access to a fluid vessel in which the native leaflet is positioned near (e.g., determine to what extent the location of the native leaflet obstructs access to the fluid vessel). For example, it can be determined whether there is sufficient space around the native leaflet (which can now be partially covering a coronary artery ostium) for a medical instrument to access the coronary artery from the aorta.
[0069] In some embodiments, the feature determination component 518 can evaluate one or more pre-procedure images, procedure images, and / or post-procedure images to identify anatomical features visible / present in the one or more images, such as walls, calcium deposits, coaptation leaflets, lumens, and / or other visible / present anatomical features. Based on identifying such visible / present anatomical features, the feature determination component 518 can determine properties / locations of the visible / present anatomical features. Further, the feature determination component 518 can identify hidden / absent anatomical features and / or properties / locations of the hidden / absent anatomical features based on the properties / locations of the visible / present anatomical features. The feature determination component 518 can store properties / locations of the present and / or absent anatomical features in the anatomical feature data store 526.
[0070] In some embodiments, the feature determination component 518 can evaluate multiple pre-procedure, procedure, and / or post-procedure images from different orientations / positions / angles. For example, the feature determination component 518 can identify one or more properties / locations of anatomical features by analyzing a first image from a first orientation / position within the patient and analyzing a second image from a second orientation / position within the patient.
[0071] Example characteristics / locations of one or more anatomical features can include characteristics / locations of native leaflets (e.g., thickness / length / width / shape of native leaflets, location of native leaflets within a heart vessel, distance of a tip of a native leaflet to a particular plane, location of a native leaflet tip based on a coapted leaflet, etc.), characteristics / locations of mineral formations (e.g., thickness / length / width / shape of mineral formations, location of mineral formations on native leaflets, location of mineral formations within a heart vessel, etc.), characteristics / locations of fluid vessels (e.g., diameter of a coronary artery, diameter of an aorta / aortic root, etc.), characteristics / locations of openings (e.g., location of a coronary ostium within an aortic valve annulus region and / or relative to native leaflets / prosthetic valve, etc.), and / or any other features / dimensions. In some embodiments, locations of anatomical features are exhibited / indicated with dimensions such as distance to another anatomical feature, distance to a prosthetic valve, distance to a mineral formation, etc. Further, in some embodiments, locations of anatomical features can include one or more coordinates of the anatomical features within a coordinate system / space.
[0072] In some embodiments, one or more characteristics / locations of an anatomical feature can include one or more characteristics / locations of a device implanted at the anatomical feature, such as a size / shape / location of a prosthetic valve implanted within a human anatomy. Further, in some embodiments, one or more characteristics / locations of an anatomical feature can include one or more characteristics / locations of a mineral formation attached and / or embedded with the anatomical feature. Further, in some embodiments, one or more characteristics / locations of an anatomical feature can include characteristics / locations of a visual representation of the anatomical feature in an image, such as a size of the visual representation, a color / shading of the visual representation, a location of the visual representation, etc. within the image.
[0073] In some embodiments, the feature determination component 518 operates in cooperation with the graphical user interface component 520. For example, the graphical user interface component 520 can be configured to provide an interface including the image. A user, such as a physician or technician, can view the image and provide input regarding characteristics of the anatomical features. In one example, the user can designate a representation in the image as representing a particular anatomical feature, such as a calcium deposit, a leaflet, a coronary artery, an aortic wall, etc. In another example, the user can designate a first point / location on the image and a second point / location in the image and provide input requesting a distance between the first point / location and the second point / location be calculated. The user can also provide input to label the distance. In examples, the user can provide input to determine / label any of the example dimensions discussed in FIG. 6 and 7 discussed in the discussion of FIGS. 5A-5C. In examples, the feature determination component 518 can utilize the input provided by the user to evaluate one or more images and / or stored data regarding one or more characteristics / locations of one or more anatomical features in the anatomical feature data store 526.
[0074] Additionally, in some embodiments, the feature determination component 518 operates in cooperation with the image processing component 522 to evaluate the images. For example, the image processing component 522 can perform one or more image processing techniques on one or more images to automatically identify one or more image-based features within the one or more images and / or classify the one or more image-based features as anatomical features. In some embodiments, the image processing component 522 utilizes one or more artificial intelligence techniques, such as one or more machine-trained models, to analyze the one or more images. In an example, the feature determination component 518 can utilize information determined by the image processing component 522 to evaluate the one or more images and / or stored data regarding characteristics / locations of one or more anatomical features in the anatomical feature data store 526.
[0075] In some embodiments, one or more of the components 518-522 evaluate one or more images to identify anatomical features that are generally not visible / presentable in the one or more images. For example, due to characteristics of the native leaflets (e.g., size / dimensions of the native leaflets), characteristics of the imaging device 502 (e.g., a detectable resolution of the imaging device 502), and / or the like, the native leaflets can not be visible / presentable in images of the heart vessel. To illustrate, the imaging device 502 can be configured to detect anatomical features that are greater than a particular size / thickness and the native leaflets can be smaller than this particular size / thickness. In some embodiments, the native leaflets can not be detected due to the native leaflets being in close proximity to the prosthetic valve, the prosthetic valve can have a greater size than the native leaflets and / or have other characteristics that result in the imaging device 502 detecting a stronger signal from the prosthetic valve, thus the native leaflets can not be detected. That is, the signal from the prosthetic valve can be stronger than the signal from the native leaflets, resulting in the native leaflets not being detected.
[0076] In some embodiments, while individual leaflets can not be visible / presentable in the images, the commissure leaflets can be visible / presentable in the images. The location / characteristics of the commissure leaflets can be used to determine the tips / ends of the native leaflets. For example, one or more of the components 518-522 can evaluate the images to identify the commissure leaflets and determine characteristics / locations of the commissure leaflets and / or other anatomical features within the heart vessel, such as a distance of mineral deposits to the tips of the native leaflets (i.e., the commissure leaflets).
[0077] The data / information generated / determined herein can be utilized in a variety of ways. In some embodiments, data regarding the characteristics / locations of anatomical features can be used to determine whether a procedure can be performed, such as a re-access procedure. For example, the computing system 506 can generate data indicating an amount of access to a coronary artery after implantation of a prosthetic valve at the aortic valve. Such data can be used to determine whether a medical instrument, such as a catheter, can access the coronary artery from the aorta. In an example, if the amount of available space is two to three times larger than the diameter of the medical instrument, it can be determined that there is sufficient space for the medical instrument to access the coronary artery. In an example, the access to the coronary artery can occur above / around / through the prosthetic valve (e.g., through a frame of the prosthetic valve), and / or above / around a native leaflet. In an example, data regarding the amount of access to an anatomical feature, such as a coronary artery, can be provided to a user, such as a physician, technician, patient, etc., to assist the user in making a decision regarding the likelihood of successfully performing a procedure and / or successfully selecting a patient for a procedure after implantation of a prosthetic valve. In an example, such information can be displayed to the user through a user interface.
[0078] Further, in some embodiments, data regarding the characteristics / locations of anatomical features can be used to generate instructions / information for performing a procedure, such as information indicating where / how a medical instrument should access a coronary artery from the aorta. The procedure can be performed by a physician and / or a robotic system (e.g., a robotically-controlled procedure). Further, in some embodiments, data regarding the characteristics / locations of anatomical features can be used during a procedure such as an initial implantation of a prosthetic valve and / or after a procedure to reposition a prosthetic valve. Such data can assist in positioning or repositioning a prosthetic valve in an appropriate location to minimize obstruction of a coronary artery and / or other anatomical features. Further, in some embodiments, data regarding the characteristics / locations of anatomical features can be used to implant an additional prosthetic valve within an implanted prosthetic valve (sometimes referred to as a "TAVI-in-TAVI procedure"). Further, in some embodiments, data regarding the characteristics / locations of anatomical features can be collected from a plurality of patients and used to determine metrics regarding the plurality of patients, such as an average location of a native leaflet, an average amount of available space to access a fluid vessel, etc. In an example, such metrics can be provided to a user to assist in making a decision regarding performance of a procedure.
[0079] As described above, the image data store 524 can store one or more images such as pre-procedure images, procedure images, and / or post-procedure images. The image data store 524 can store images from the imaging device 502 and / or other imaging devices. Similarly, the anatomical feature data store 526 can store data regarding characteristics / locations of pre-procedure anatomical features, procedure anatomical features, and / or post-procedure anatomical features. The anatomical feature data store 526 can store data determined / generated by the feature determination component 518, the graphical user interface component 520, the image processing component 522, and / or another device / system. Although the image data store 524 and the anatomical feature data store 526 are illustrated as being included within the computing system 506, in some embodiments, the image data store 524 and / or the anatomical feature data store 526 can be implemented elsewhere, such as within a remote resource.
[0080] The imaging device 502 can be implemented as one or more computed tomography (CT) or computed axial tomography (CAT) devices, magnetic resonance imaging (MRI) devices, x-ray devices, ultrasound devices, infrared thermal imaging (IRT) devices, positron emission tomography (PET) devices, and / or other types of medical imaging devices. The imaging device 502 can generally be configured to capture / generate one or more images, including visual representations of internal anatomical structures, such as visual representations of organs / tissues / other anatomical features of a patient. In some embodiments, the imaging device 502 captures / generates one or more images from different orientations / angles of the patient 504. This can allow for viewing of the anatomical structure of the patient 504 with different data slices and / or from different orientations. The imaging device 502 can be configured to produce two-dimensional (2D) images, three-dimensional (3D) images, models, etc. In some embodiments, contrast dye or other substances are utilized to assist in capturing / generating the images. For example, it can be necessary for the patient to ingest a substance having contrast dye to assist in capturing / generating the images with the imaging device 502.
[0081] As illustrated, the imaging device 502 can individually / independently and / or in combination / jointly include one or more of the following components, devices, modules, and / or units (referred to herein as "components"): a control circuit 528, one or more network interfaces 530, a data store / memory 532, one or more I / O components 534, and one or more imaging components 536. Although the control circuit 528 is illustrated as being included within the imaging device 502, in some embodiments, the control circuit 528 can be implemented elsewhere, such as within a remote resource. FIG. 5 Certain components of the imaging device 502 are illustrated in FIG. 5, but it should be understood that other components not shown can also be included in embodiments consistent with the present disclosure. Moreover, certain illustrated components can be omitted in some embodiments. Although the control circuit 528 is illustrated as being included within the imaging device 502, in some embodiments, the control circuit 528 can be implemented elsewhere, such as within a remote resource. FIG. 5The example in the diagram of imaging device 502 is a single component, but it should be understood that any or all of the remaining components of imaging device 502 can be at least partially embodied in control circuit 528. That is, control circuit 528 can include various devices (active and / or passive), semiconductor materials and / or domains, layers, regions, and / or portions thereof, conductors, leads, vias, connectors, and / or the like, in which one or more other components of imaging device 502 and / or portions thereof can be at least partially formed and / or embodied.
[0082] The various components of imaging device 502 can be electrically and / or communicatively coupled using certain connectivity circuitry / devices / features, which can or can not be part of control circuit 528. For example, the connectivity feature(s) can include one or more printed circuit boards configured to facilitate mounting and / or interconnection of at least some of the various components / circuitry of imaging device 502. In some implementations, two or more of control circuit 528, network interface(s) 530, data storage / memory 532, I / O component(s) 534, and / or imaging component(s) 536 can be electrically and / or communicatively coupled to one another.
[0083] The network interface(s) 530 can be configured to communicate with one or more devices / systems over the network(s) 508. For example, the network interface(s) 530 can transmit / receive data, such as one or more images, over a network in a wireless and / or wired manner. In some implementations, the network interface(s) 530 can implement wireless technologies, such as Bluetooth, Wi-Fi, near field communication (NFC), or the like.
[0084] The one or more I / O components 534 can include a number of components that receive input and / or provide output (e.g., to interface with a user). The one or more I / O components 534 can be configured to receive touch, voice, gesture, or any other type of input. Further, the one or more I / O components 534 can be configured to output display data, audio data, haptic feedback data, or any other type of output data. The one or more I / O components 534 can include one or more displays (sometimes referred to as “one or more display devices”), touchscreens, touchpads, controllers, mice, keyboards, wearable devices (e.g., optical head-mounted displays), virtual or augmented reality devices (e.g., head-mounted displays), speakers (e.g., configured to output sound according to audio signals), microphones (e.g., configured to receive sound and generate audio signals), cameras, and the like. The one or more displays can include one or more liquid crystal displays (LCDs), light-emitting diode (LED) displays, organic LED displays, plasma displays, electronic paper displays, and / or any other type(s) of technology. In some embodiments, the one or more displays include one or more touchscreens configured to receive input and / or display data.
[0085] The one or more imaging components 536 can include generators, sensors, detectors, cameras, and the like configured to provide / generate signals / radiation and / or receive / detect signals / radiation, which can be used to capture / generate one or more images. In some embodiments, the imaging device 502 can include a structure that holds and / or moves the patient 504 in proximity to the one or more imaging components 536.
[0086] The term "control circuit" is used herein according to its broad and ordinary meaning, and can refer to any collection of one or more processors, processing circuitry, processing modules / units, chips, dies (e.g., semiconductor dies, including one or more active and / or passive devices and / or connectivity circuitry), microprocessors, microcontrollers, digital signal processors, microcomputers, central processing units, graphics processing units, field-programmable gate arrays, programmable logic devices, state machines (e.g., hardware state machines), logic circuitry, analog circuitry, digital circuitry, and / or any device that manipulates signals (analog and / or digital) based on hard coding of the circuitry and / or operational instructions. A control circuit can further include one or more storage devices, which can be embodied in a single storage device, multiple storage devices, and / or embedded circuitry of the device. Such data storage can include read-only memory, random access memory, volatile memory, non-volatile memory, static memory, dynamic memory, flash memory, cache memory, data storage registers, and / or any device that stores digital information. It should be noted that in embodiments where the control circuit includes a hardware state machine (and / or implements a software state machine), analog circuitry, digital circuitry, and / or logic circuitry, the data storage device(s) / register(s) storing any associated operational instructions can be embedded within or external to the circuitry including the state machine, analog circuitry, digital circuitry, and / or logic circuitry.
[0087] The term "memory" is used herein according to its broad and ordinary meaning, and can refer to any suitable or desired type of computer-readable medium. For example, a computer-readable medium can include one or more volatile data storage devices, non-volatile data storage devices, removable data storage devices, and / or non-removable data storage devices implemented in any technology, layout, and / or data structure(s) / protocol, including any suitable or desired computer-readable instructions, data structures, program modules, or other types of data.
[0088] Computer-readable media that can be implemented in accordance with embodiments of the present disclosure include, but are not limited to, phase change memory, static random access memory (SRAM), dynamic random access memory (DRAM), other types of random access memory (RAM), read only memory (ROM), electrically erasable programmable read only memory (EEPROM), flash memory or other memory technology, compact disc read only memory (CD-ROM), digital versatile discs (DVD) or other optical storage, magnetic cassettes, magnetic tapes, magnetic disk storage or other magnetic storage devices, or any other non-transitory medium that can be used to store information for access by a computing device. As used in some contexts in this document, computer-readable media can not generally include communication media such as modulated data signals and carrier waves. Thus, computer-readable media should generally be understood to refer to non-transitory media.
[0089] Example heart vasculature
[0090] FIG. 6 and 7 Cross-sectional views of example anatomical features and properties / locations of the anatomical features are illustrated in accordance with one or more embodiments. Specifically, FIG. 6 and 7 Anatomical features associated with the aorta 602 are illustrated, namely the aortic annulus / valve region, including native leaflets 604 attached to the aortic annulus 606 at the tips 608 of the native leaflets 604 and the coronary arteries 610 fluidly connected to the aorta 602 via the coronary ostia 612. As shown, the native leaflets 604 include calcifications 614 embedded in and / or attached to the native leaflets 604. In these examples, the coronary arteries 610 are left coronary arteries, which in some cases can have a higher risk of occlusion after a prosthetic valve implantation as compared to the right coronary arteries. However, it should be understood that the description regarding the left coronary arteries 610 can be similarly applicable to the right coronary arteries (not shown), another type of fluid vessel, and / or any other anatomical feature. FIG. 6 Native leaflets 604 in a pre-procedure state without a prosthetic valve 702 implanted within the aortic valve are illustrated, FIG. 7 Native leaflets 604 in a post-procedure state with a prosthetic valve 702 implanted within the aortic valve are illustrated.
[0091] In some embodiments, the techniques and systems discussed herein can evaluate the display of FIG. 6One or more pre-procedure images of the anatomical features shown are used to identify visible / displayed anatomical features in the one or more pre-procedure images, such as the aortic wall (one or more), calcium deposits 614, lobule tips / termini (e.g., based on occlusive lobules), coronary arteries 610, and / or other visible / displayed anatomical features. In some examples of evaluating the one or more pre-procedure images, lobule tips / termini may be identified when a natural lobule occludes with another lobule, such as during closure / diastole. Based on the identification of visible / displayed anatomical features in the one or more pre-procedure images, the technique and system can determine the characteristics / location of the visible / displayed anatomical features (and / or hidden / undisplayed anatomical features) in cases where the location is displayed in one or more sizes.
[0092] FIG. 6 The following are some example dimensions that can be determined for one or more pre-procedural images (which can show / identify the location of anatomical features), including: distance / size A between the plane 618 of the valve annulus and the plane 620 (also referred to as “lower plane 620”) of the coronary artery ostium 612; distance / size B between the plane 622 of natural lobule occlusion and the plane 624 of natural commissure; diameter / size C of the coronary artery 610 (which can show the diameter of the left coronary artery 610 near its ostium 612); distance / size D between the upper end of the calcium deposit 614 and the lower plane 620 of the coronary artery ostium 612; distance / size E between the upper end 616 of the calcium deposit 614 and the lower end 616 of the leaflet 604; distance / size F between the plane 618 of the valve annulus and the plane 622 of natural lobule occlusion; and / or distance / size G between the upper end of the calcium deposit 614 and the plane 618 of the valve annulus.
[0093] In some embodiments, if the upper end of the calcium deposit 614 during diastole is located below the plane 620 of the coronary ostium 612, such as FIG. 6 As shown, distance D can be associated with an identifier to indicate this situation (e.g., a positive sign (+)). Furthermore, if the upper end of calcium deposit 614 is located above the plane 620 of the coronary ostium 612 during diastole, distance D can be associated with an identifier to indicate this situation (e.g., a negative sign (-)).
[0094] FIG. 7 An example of a 702 prosthetic valve implanted therein was shown. FIG. 6 Example of an aortic valve. Specifically, a prosthetic valve 702 is expanded at the aortic valve to an implanted / deployed state. As shown, the natural leaflet 604 is repositioned to a substantially straight and vertical position. At this point, the natural leaflet 604 and / or the prosthetic valve 702 at least partially obstruct the coronary ostium 612.
[0095] In some implementations, the techniques and systems discussed herein can be evaluated and demonstrated. FIG. 7 One or more procedural / post-procedural images of the anatomical features shown are used to identify visible / displayed anatomical features in the one or more images, such as the aortic wall (one or more), calcium deposits 614, coronary arteries 610, prosthetic valves 710, and / or other visible / displayed anatomical features. Based on the identification of visible / displayed anatomical features in the one or more procedural / post-procedural images, the technique and system can determine the characteristics / location of the visible / displayed anatomical features (and / or hidden / undisplayed anatomical features) in cases where the location is displayed in one or more sizes.
[0096] FIG. 7 The following are some example dimensions (which can show / identify the location of anatomical features) that can be determined with respect to one or more procedural images / post-procedural images, including: the distance / size H between the plane 620 of the coronary ostium 612 and the upper end of the calcium deposit 614 (e.g., the plane 704 of the upper end of the calcium deposit 614); the distance / size I between the frame of the prosthetic valve 702 and the center of the coronary ostium 612; the distance / size J between the plane 704 of the upper end of the calcium deposit 614 and the plane 706 of the sino-tubular junction (STJ); and / or the distance / size K between the plane 704 of the upper end of the calcium deposit 614 and the upper end 708 of the prosthetic valve 702.
[0097] In some implementations, if the upper end of the calcium deposit 614 is below the plane 620 of the coronary ostium 612 after the prosthetic valve 702 is deployed, the distance H can be associated with an identifier to indicate this situation (e.g., a positive sign (+)). Furthermore, if the upper end of the calcium deposit 614 is above the plane 620 of the coronary ostium 612 after the prosthetic valve 702 is deployed, such as... FIG. 7 As shown, distance H can be associated with an identifier to indicate this situation (e.g., a minus sign (-)). Furthermore, in some embodiments, when the prosthetic valve 702 is implanted, the upper / terminal portion of the natural leaflet 604 is positioned close to the center of the coronary ostium 612.
[0098] In some implementations, the techniques and systems discussed herein may be based on the references above. FIG. 6and / or 7 to determine one or more other dimensions to demonstrate / identify anatomical features of the implanted prosthetic valve 702, including, for example: a distance / dimension K-H (i.e., distance K plus distance H) between the superior end 708 of the prosthetic valve 702 and the plane 620 of the coronary ostium 612; a distance / dimension J-K (i.e., distance J minus distance K) between the STJ plane 706 and the superior end 708 of the prosthetic valve 702; a distance / dimension J-E (i.e., distance J minus distance E) between the STJ plane 706 and the superior end / terminus 616 of the native leaflet 604; a distance / dimension K-E (i.e., distance K minus distance E) between the superior end 708 of the prosthetic valve 702 and the superior end 616 of the native leaflet 604; and / or a distance / dimension E-H (i.e., distance E plus distance H) between the superior end 616 of the native leaflet 604 and the plane 620 of the coronary ostium 612.
[0099] In some embodiments, the techniques and systems discussed herein can utilize one or more of the dimensions discussed above to determine an amount of access to the coronary artery 620. For example, the distances K-H, K-E, and / or J-E can indicate an amount of space available to access the coronary artery 610 above the prosthetic valve 702 / through the prosthetic valve 702 and / or above the native leaflet 604. In other words, the distances K-H, K-E, and / or J-E can indicate a degree to which the prosthetic valve 702 and / or the native leaflet 604 obstructs the coronary ostium 612 to the coronary artery 610. Such information can be used to determine whether a procedure can be performed on an access to the coronary artery 610 due to the implantation of the prosthetic valve 702. As shown, the amount of access to the coronary artery 610 is reduced after the prosthetic valve 702 is implanted in the aortic valve (as shown) compared to an aortic valve without a prosthetic valve (as shown). FIG. 6 As shown, the amount of access to the coronary artery 610 is reduced after the prosthetic valve 702 is implanted in the aortic valve (as shown) compared to an aortic valve without a prosthetic valve (as shown). FIG. 7 Although the distances K-H, K-E, and / or J-E are discussed in examples, one or more other dimensions can be used to determine an amount of space available to access the coronary artery 610.
[0100] Although some example dimensions are discussed with reference to FIG. 6 and 7 In some embodiments, the techniques and systems discussed herein can utilize one or more algorithms to determine distances / dimensions associated with anatomical features, such as algorithms that convert a number of pixels in an image or a distance between pixels to a distance / dimension of an anatomical feature.
[0101] Example flowchart
[0102] FIG. 8A 、 8BFIGS. 9 and 9 illustrate example flowcharts of processes for performing one or more techniques discussed herein. Various blocks related to the processes are performed by one or more devices / systems, users, etc. For example, one or more of the blocks can be performed by the control circuit of the computing system 506 and / or the imaging device 502, and / or by a physician, technician, and / or any other user.
[0103] FIG. 8A-8B FIG. 8 illustrates an example flowchart of a process 804 for analyzing one or more images to determine a location / characteristic of an anatomical feature in accordance with one or more embodiments. In FIG. 8A In block 802, the process 800 can include obtaining one or more first images that illustrate a native valve within a heart vessel. In some embodiments, the control circuit of a device / system can receive one or more pre-procedural images from an imaging device. The one or more pre-procedural images can include data that illustrate an aortic valve within a heart vessel, such as an aortic annulus region. Further, in some embodiments, a user can obtain / receive one or more pre-procedural images from an imaging device, a computing system, and / or another device / system.
[0104] In block 804, the process 800 can include analyzing the one or more first images to determine one or more characteristics / locations of one or more mineral deposits. In an example, a characteristic of a mineral formation can include a size / shape / dimension of the mineral formation. Further, in an example, a location of a mineral formation can include a location of the mineral formation relative to an anatomical feature, such as a tip / terminal end or other portion of a native leaflet, a coronary artery, an aortic wall, a coordinate system / space, etc.
[0105] In some embodiments, as illustrated in block 806, the control circuit can perform one or more image processing techniques on the one or more pre-procedural images to determine one or more characteristics / locations of one or more mineral formations. For example, the one or more image processing techniques can include detection that seeks to identify one or more image features (e.g., edges, corners, blobs, ridges, etc.) within an image, tracking that seeks to track one or more image features throughout an image / frame, and / or classification that seeks to classify the one or more image features into one or more categories. In an example, the one or more image processing techniques can utilize one or more models, such as a machine-trained model, a user-trained model, or other model trained to classify image features (e.g., as image features that illustrate mineral formations). In some embodiments, the control circuit can determine a reference FIG. 6 and 7 Any of the dimensions discussed.
[0106] Furthermore, in some embodiments, as exemplified in block 806, the control circuitry may provide a user interface and / or receive input regarding one or more characteristics / locations of one or more mineral formations. For example, the control circuitry may generate user interface data displaying a user interface including a pre-program image and / or send the user interface data to a display device displaying the user interface including the pre-program image. The user can view the pre-program image through the interface and provide input to identify the location of the mineral formation. In one example, the user may designate a display / location in the image as a display of a mineral formation. In another example, the user may designate a first point / location and a second point / location on the image and provide input requesting the calculation of the distance between the first point / location and the second point / location. The first point / location and / or the second point / location may be on or near the mineral display. Thus, the distance may indicate the location of the mineral formation relative to another feature. In some embodiments, the user may select various points / locations on the image to designate (and / or have the control circuitry determine) a reference. FIG. 6 and 7 The discussion covers any size.
[0107] In some implementations, the control circuitry and / or the user may identify the tips / termini of natural leaflets based on fused leaflets (i.e., leaflets that are in contact with or close to each other). For example, the control circuitry and / or the user may identify regions in an image associated with a specific shading / color / size, which is generally associated with fused leaflets. The control circuitry and / or the user may designate regions of fused leaflets as the tips / termini of natural leaflets. In an example, the control circuitry and / or the user may determine the location of mineral formation relative to the tips / termini of natural leaflets, such as the distance between the location of mineral formation and the tips / termini of natural leaflets.
[0108] At block 810, process 800 may include generating pre-process data indicating one or more characteristics / locations of the formation of the one or more minerals. In some embodiments, control circuitry may generate pre-process data indicating one or more characteristics / locations of the formation of the one or more minerals based on the characteristics / locations determined / identified at block 804. Once generated, the pre-process data may be stored in data storage, such as data storage associated with the control circuitry and / or located on a network.
[0109] At block 812, process 800 may include acquiring one or more second images showing a prosthetic valve implanted at a natural valve site. In some embodiments, control circuitry may receive one or more programmed / post-programmed images from an imaging device. The one or more programmed / post-programmed images may include data showing a prosthetic valve in the heart's blood vessels, such as a prosthetic aortic valve deployed in the aortic valve. Furthermore, in some embodiments, a user may acquire / receive one or more programmed / post-programmed images from an imaging device, a computing system, and / or other devices / systems.
[0110] At block 814, process 800 may include obtaining pre-procedure data. In some embodiments, control circuitry may retrieve (read out) the pre-procedure data from data storage, which in some cases may be located on a network. In the example, the pre-procedure data may indicate one or more characteristics / locations of one or more mineral formations prior to implantation of the prosthetic valve. Furthermore, in some embodiments, a user may obtain / receive the pre-procedure data.
[0111] exist FIG. 8B In the context of box 816, process 800 may include analyzing the one or more second images to determine one or more characteristics / locations of one or more mineral formations and / or one or more characteristics / locations of a prosthetic valve.
[0112] In some implementations, as shown in block 818, the control circuitry may perform one or more image processing techniques on one or more procedural / post-procedural images to determine one or more characteristics / locations of one or more mineral formations. These image processing techniques may include one or more of the techniques discussed above with reference to block 806. In an example, the control circuitry may obtain pre-procedural data indicating characteristics of mineral formation / pre-procedural mineral display, such as the size / shape / color of the mineral formation and / or the size / shape / color of the visual display of the mineral formation in the pre-procedural image. The control circuitry may utilize the pre-procedural data to identify mineral displays in the procedural / post-procedural images that have one or more characteristics similar to the mineral formation / mineral display in the pre-procedural image (e.g., satisfying one or more similarity thresholds).
[0113] Additionally, in some embodiments, the control circuit can perform one or more image processing techniques on the one or more program images / post-procedure images to determine one or more characteristics / locations of the prosthetic valve. For example, if one or more of the renderings are positioned along a substantially vertical plane / axis, are connected together via one or more connections, have characteristics of a typical prosthetic valve, etc., the control circuit can identify one or more of the renderings in the post-procedure images as corresponding to one or more elements of the prosthetic valve. In an example, the control circuit can reference a prosthetic valve database to identify characteristics of the prosthetic valve such as a size / shape of a typical frame or other features of the prosthetic valve.
[0114] Additionally, in some embodiments, the control circuit can also provide a user interface to the user and / or receive input regarding one or more mineral formations and / or one or more characteristics / locations of the prosthetic valve, as also illustrated in block 818. For example, the control circuit can generate and / or transmit user interface data to a display device that displays a user interface including the program images / post-procedure images. The user can view the program images / post-procedure images through the interface and provide input identifying locations of the mineral formations and / or locations of the prosthetic valve, similar to one or more techniques discussed above with reference to block 806. In an example, the user interface can view pre-procedure images and / or information regarding the mineral formations in the pre-procedure images to assist the user in identifying the mineral formations in the program images / post-procedure images.
[0115] At block 820, the process 800 can include determining a location of a native valve within the heart vessel. In some embodiments, the control circuit and / or the user can determine a location of a native valve / leaflet within the heart vessel based on a location of the mineral formations on the native leaflet prior to implantation of the prosthetic valve (which can be indicated in the pre-procedure data) and / or a location of the mineral formations within the heart vessel after implantation of the prosthetic valve. In an example, a location / orientation of the native leaflet can be estimated based on a location of one or more of the mineral formations and / or a location of the prosthetic frame. For example, if multiple mineral formations are identified in a substantially vertical plane / axis and / or a frame element of the prosthetic valve, it can be estimated that the native leaflet is substantially parallel to and / or within a distance from the vertical plane / axis.
[0116] At block 822, the process 800 can include determining an access to a fluid vessel associated with the heart vessel. For example, the control circuit and / or the user can determine an amount of access to the fluid vessel associated with the heart vessel based on a location of the native valve within the heart vessel after implantation of the prosthetic valve, a location of the prosthetic valve within the heart vessel, etc. The amount of access can be indicative of available space above the native leaflet and / or a portion of the prosthetic valve above the native leaflet. In some embodiments, the control circuit can determine the amount of access based on a distance between the native leaflet and the prosthetic valve and / or a distance between the prosthetic valve and the fluid vessel. FIG. 6and / or one or more dimensions shown in FIG. 7, and utilize the one or more dimensions to determine an amount of available space, such as space between a distal / end of a native leaflet and a portion of the aortic wall substantially above the distal / end of the native leaflet, space between an upper end of a prosthetic valve and a portion of the aortic wall substantially above the end of the prosthetic valve, etc.
[0117] Further, in some embodiments, the control circuit can provide a program image / program post image to a user interface, and a user can provide input to select an upper end of a mineral formation and select a portion of the aortic wall. The user can provide input requesting a distance between the upper end of the mineral formation and the portion of the aortic wall be calculated. The control circuit can determine such a distance and utilize the distance, along with any other distances, to determine an amount of access space.
[0118] At block 824, the process 800 can include generating data indicative of one or more characteristics / locations of the native valve and / or the prosthetic valve. For example, the control circuit can generate data indicative of one or more characteristics / locations of the native valve / leaflet and / or the prosthetic valve after the prosthetic valve is implanted within the heart vessel. In some embodiments, the data can also be indicative of an amount of access to the fluid vessel, such as a dimension indicative of an amount of access to the fluid vessel. The control circuit can store the data in a data store.
[0119] At block 826, the process 800 can include providing an indication indicative of an access condition of the fluid vessel, such as a coronary artery access condition. In some examples, an indication can be provided indicative of a risk / risk level associated with performing a procedure including accessing the fluid vessel (e.g., a high / medium / low risk of coronary artery occlusion resulting from implantation of a prosthetic valve and / or a location of a native leaflet). For example, the indication can indicate that an access to a coronary artery is completely occluded, partially occluded, open (e.g., unoccluded), etc. The indication can be based on and / or indicative of an amount of access to the fluid vessel. In some embodiments, the indication is provided to a user via a display or other output device, such as a visual / audio presentation. However, the indication can be provided in other ways. In some embodiments, a patient can be associated with the indication indicative of the access condition of the fluid vessel.
[0120] At block 828, the process 800 can include performing or refraining from performing a procedure including accessing the fluid vessel. In some embodiments, the process 800 can include determining that the amount of access to the coronary artery is less than a threshold value and / or determining that the risk / risk level is a particular value (e.g., a relatively high risk coronary obstruction) and refraining from performing the procedure including accessing the coronary artery based on such determination. Alternatively or additionally, the process 800 can include determining that the amount of access to the coronary artery is greater than a threshold value and / or determining that the risk / risk level is a particular value (e.g., a relatively low risk coronary obstruction) and performing the procedure including accessing the coronary artery based on such determination.
[0121] One or more of blocks 802-828 can be performed at various times. In some embodiments, one or more of blocks 802-810 can be performed prior to implanting the prosthetic valve, and one or more of blocks 812-828 can be performed after implanting the prosthetic valve. Further, in some embodiments, one or more of blocks 802-810 can be performed after implanting the prosthetic valve. For example, one or more pre-procedural images taken prior to implanting the prosthetic valve can be analyzed after implanting the prosthetic valve. However, blocks 802-828 can be performed at other times and / or in any order.
[0122] FIG. 9 An example flowchart illustrating a process 900 for providing an interface to determine a location / feature of an anatomical feature in accordance with one or more embodiments is shown. At block 902, the process 900 can include receiving data indicative of a location / feature of a mineral formation. For example, the control circuit can retrieve pre-procedural data from a data store. In some embodiments, the pre-procedural data can be indicative of one or more features / locations of one or more mineral formations prior to implanting a prosthetic valve, such as a location of a mineral formation relative to a tip / terminus of a native leaflet.
[0123] At block 904, the process 900 can include generating graphical interface data that presents an image of a prosthetic valve implanted at a native valve. For example, the control circuit can generate user interface data that presents a user interface including a procedural image / post-procedural image of a prosthetic valve implanted at a native valve.
[0124] At block 906, the process 900 can include providing the graphical interface data to a display device. For example, the control circuit can transmit the graphical interface data to a display device that displays the user interface, including the procedural image / post-procedural image. In some embodiments, the display device is a component of a computing system in which the control circuit is located, while in other embodiments the display device is a component of another computing system.
[0125] At block 908, the process 900 can include receiving input regarding the location / characteristics of the mineralization depicted in the image. For example, the control circuit can receive input regarding the location / characteristics of the mineralization depicted in the procedural image / post-procedural image through the user interface, such as input identifying the location of the mineralization formation, the size associated with the mineralization formation, and the like.
[0126] At block 910, the process 900 can include performing one or more image processing techniques on the image. For example, the control circuit can perform one or more image processing techniques on the procedural image / post-procedural image to determine that the mineralization depicted in the image depicts mineralization on a native leaflet. In an example, the one or more image processing techniques can utilize data indicative of one or more characteristics of the mineralization formation.
[0127] At block 912, the process 900 can include determining the location of a native valve and / or a prosthetic valve within a heart vessel. For example, the control circuit can determine the location of a native valve / leaflet within a heart vessel based on the input received at block 908, the image processing performed at block 910, and / or pre-procedural data indicative of the location / characteristics of the mineralization formation.
[0128] At block 914, the process 900 can include determining an approach to a fluid vessel associated with the heart vessel. For example, the control circuit can determine an amount of an approach to a coronary artery based on the location of the native valve / leaflet and / or the location of at least a portion of the prosthetic valve within the heart vessel.
[0129] Example images
[0130] FIG. 10 and 11 Example pre-procedural and post-procedural images 1000 and 1100, respectively, that can be generated by an imaging device are illustrated in accordance with one or more embodiments. In these examples, the images 1000 and 1100 depict CT images or x-ray images that depict various anatomical features within an aortic valve region. For example, the images 1000 and 1100 depict an aortic valve 1002 positioned between a left ventricle 1004 and an aorta 1006 and depict a coronary artery 1008 positioned above the aortic valve 1002. FIG. 10 depicts the aortic valve region in a pre-procedural state without a prosthetic valve 1102, whereas FIG. 11 depicts the aortic valve region with the prosthetic valve 1102 implanted to replace the aortic valve 1002. Although the native leaflets of the aortic valve 1002 are typically not visible / depicted in CT images or x-ray images, for ease of illustration, the native leaflets of the aortic valve 1002 are shown in FIG. 10 and 11 are shown in dashed lines in the images 1000 and 1100, respectively.
[0131] In these examples, the aortic valve 102 includes calcium deposits 1010, which may appear as a white display (e.g., a brighter area) within images 1000 and 1100. Calcium deposits 1010 may include specific characteristics / locations that enable them to be detected by the imaging apparatus. For example, each calcium deposit 1010 may have a size that satisfies a size / thickness threshold associated with detection by the imaging apparatus. Although examples of calcium deposits 1010 are attached to the top of the natural leaflet of the aortic valve 1002, in these examples, calcium deposits 1010 may be attached to / embedded below and / or within the natural leaflet.
[0132] like FIG. 10 As shown, the pre-procedure image 1000 also includes a slightly darker region 1012 depicting the occlusal leaflets. The occlusal leaflets may include specific characteristics / locations that enable them to be detected by the imaging device. For example, since the occlusal leaflets comprise two or more natural leaflets that may be in contact or close to each other, creating a region significantly thicker than a single natural leaflet, the occlusal leaflets can meet size / thickness thresholds associated with detection by the imaging device. Region 1012 generally displays the tips / termini of the natural leaflets of the aortic valve 1002. Therefore, although the natural leaflets of the aortic valve 1002 may generally not be visible / displayed in the pre-procedure image 1000, the tips / termini of the natural leaflets can be visible / displayed (e.g., the darker region 1012) when the natural leaflets of the aortic valve 1000 are occlusal with another leaflet.
[0133] In some implementations, the systems and techniques discussed herein can be analyzed. FIG. 10 The system and techniques are used to identify visible / displayed features within the pre-process image 1000 and / or determine one or more characteristics / locations of visible / displayed features and / or hidden / undisplayed features. For example, the system and techniques may identify calcium deposits 1010, the region 1012 displaying the distal / terminal portion of the natural leaflet of the aortic valve 1002, the aortic wall, the coronary arteries 1008, and / or other anatomical features. The system and techniques may also determine characteristics of these features, such as the location of the feature, the size / shape of the feature, etc. In some embodiments, the system and techniques may utilize the location of the calcium deposits 1010 to estimate the location of the natural leaflet of the aortic valve 1002. For example, the location of the natural leaflet of the aortic valve 1002 may be estimated as below / above / at the calcium deposits 1010. Data (and / or other information) regarding the characteristics / location of calcium deposit 1010 and / or the estimated characteristics / location of the natural leaflets of aortic valve 1002 may be stored as pre-procedural data.
[0134] As mentioned above,FIG. 11 An example is shown in post-procedure image 1100 depicting the aortic valve region, where a prosthetic valve 1102 has been implanted to replace the aortic valve 1002. At this point, the natural leaflets of the aortic valve 1002 are pressed against the aortic wall and coronary artery 1008 by the radially outward force exerted by the prosthetic valve 1002. Since the frame of the prosthetic valve 1102 can generally have a size / thickness that meets the size / thickness threshold associated with detection by the imaging device, the frame of the prosthetic valve 1102 can be detected by the imaging device and displayed in post-procedure image 1100. FIG. 11 As shown, the framework of the prosthetic valve 1102 is depicted in white (e.g., showing multiple framework elements / parts).
[0135] In some implementations, the systems and techniques discussed herein can be analyzed. FIG. 11 The post-procedure image 1100 is used to identify visible / displayed features within the post-procedure image 1100 and / or determine one or more characteristics / locations of visible / displayed features and / or hidden / undisplayed features. For example, the system and techniques can identify calcium deposits 1010, the aortic wall, coronary arteries 1008, prosthetic valve 1102 frame elements, and / or other anatomical features. The system and techniques can also determine characteristics of these features, such as the location of the feature, the size / shape of the feature, etc. In some embodiments, the system and techniques can utilize the location of calcium deposits 1010 in the pre-procedure image 1000 to estimate the location of the natural leaflets of the aortic valve 1002 and / or the access pathway to the coronary arteries 1008 (e.g., the amount of access pathway to the coronary arteries 1008). Data regarding the characteristics / location of calcium deposits 1010, the estimated characteristics / location of the natural leaflets of the aortic valve 1002, and / or the estimated access pathway (and / or other information) can be stored as post-procedure data. In some implementations, the systems and techniques discussed herein can map potential sinus sequestration.
[0136] Other features and implementations
[0137] The above description of the disclosed implementations is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed above. While specific implementations and examples are described above, a person having ordinary skill in the relevant art will appreciate a variety of equivalent modifications and alternative constructions that fall within the scope of the disclosure. For example, although processes or blocks are presented in a given order, alternative implementations can perform routines having steps, or employ systems having blocks, in a different order, and some processes or blocks can be deleted, moved, added, subdivided, combined, and / or modified to provide alternative or equivalent implementations. Each of these processes or blocks can be implemented in a variety of different ways. Also, while processes or blocks are at times shown as being performed in series, these processes or blocks can instead be performed or implemented in parallel, or can be performed at different times.
[0138] Certain positional terms are used herein with respect to various disclosed implementations. Although certain spatially relative terms, such as "outer," "inner," "upper," "lower," "below," "above," "vertical," "horizontal," "top," "bottom," and like terms are used herein for the purpose of describing the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it is understood that these terms are used herein for ease of description to describe the positional relationship between elements(s) / structure(s) as illustrated in the drawings. The spatially relative terms are intended to encompass different orientations of the elements(s) / structure(s) in use or operation in addition to the orientations depicted in the drawings. For example, an element / structure described as being "above" another element / structure can also exhibit an orientation relative to the object patient or element / structure in which it is positioned below or beside the other element / structure, or vice versa.
[0139] Conditional language used herein, such as, among others, "can," "could," "might," "may," "e.g.," and like terms, is intended to be conditional language and is used in the sense that a feature, element, or step being described can or can not be utilized, employed, or made, as appropriate, depending on the circumstances, and is not intended to be exclusive or exhaustive of various implementations of the disclosure. Thus, such conditional language is not intended to imply that a feature, element, or step is necessary or indispensable for one or more implementations of the disclosure, or that a feature, element, or step is necessary or indispensable for the inclusion of logic to determine (with or without author input or prompting) whether the feature, element, or step is included or will be performed in any particular implementation.
[0140] It should be understood that certain ordinal terms (e.g., “first” or “second”) can be provided for ease of reference only and do not necessarily imply a physical or chronological order. Thus, as used herein, ordinal terms for modifying elements, such as structures, components, operations, etc. (e.g., “first,” “second,” “third,” etc.) do not necessarily indicate a priority or order of the element relative to another element, but rather, the element can be generally distinguished from another element having a similar or identical name (but not using ordinal terminology). Additionally, as used herein, the indefinite articles “a” and “an” can indicate “one or more” rather than “one.” Furthermore, an operation performed “based on” a certain condition or event can also be performed based on one or more other conditions or events that are not explicitly recited. In some cases, an operation or event is described as being performed “based on” or “at least in part on” an operation or event that occurs or is performed can be understood as being triggered by or performed in response to the recited event or condition.
[0141] With respect to the various methods and processes disclosed herein, although certain orders of example and / or described operations are illustrated, it should be appreciated that the various steps and operations can be performed in any suitable or desirable order. Moreover, any example and / or described operations can be omitted from any given method or process, and example / described methods and processes can include other operations not explicitly illustrated or described.
[0142] It should be understood that, in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description of a process for ease of understanding and to help illustrate one or more aspects of the disclosure. However, this disclosure method should not be construed that any claim requires more features than explicitly recited in that claim. Moreover, any of the components, features, or steps in any of the specific embodiments described herein can be applied to any of the other embodiments (one or more) or used in any other embodiment (one or more). Also, for each embodiment, any of the components, features, steps, or combinations of components, features, or steps are not essential or indispensable. Thus, it is intended that the scope of the disclosure herein should not be limited by the above description of specific embodiments, but should instead be determined by a fair reading of the claims together with the full range of equivalents to which such claims are entitled.
[0143] Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise," "comprising," "have," "having," "include," "including," and the like are to be construed in an open, inclusive way, in contrast to the more restrictive "consist of," "consisting of," "consists of," "consisting only of," and the like. That is, the terms "comprise," "comprising," "have," "having," "include," "including," and the like are not intended to be limiting, but to the contrary, are intended to cover also
[0144] As generally used herein, the word "coupled" means the direct or indirect coupling between or among two or more elements, whether mechanical, electrical, and / or otherwise, without being necessarily directly in physical contact between them (e.g., via one or more intermediate elements, components, and / or devices). Also, the words "herein," "above," "below," and words of similar meaning are used herein to refer to this application as a whole, including the disclosure of any patent or application incorporated by reference herein, and not to the individual sections, unless the context clearly requires otherwise. Where the context permits, words in the singular or plural number used in this disclosure can also include the plural or singular number, respectively.
[0145] The word "or" means to any one of the listed items, or any combination of the listed items, in an inclusive, rather than an exclusive, sense unless the context clearly requires otherwise. Also, the term "and / or" as used herein refers to any one or more of the items in the list, in which the items are separated by "and / or" in the list. For example, a phrase such as "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."
[0146] As can be used herein, the terms "substantially" and "approximately" provide the industry-accepted tolerances for their corresponding terms and / or relationships between items. For some industries, the industry-accepted tolerances are less than 1%, while for other industries, the industry-accepted tolerances can be 10% or more. Other examples of industry-accepted tolerances range from less than 1% to 50%. Industry-accepted tolerances correspond to, but are not limited to, component values, integrated circuit process variations, temperature variations, rise and fall times, thermal noise, dimensions, signaling errors, dropped packets, temperature, pressure, material composition, and / or performance metrics. Within an industry, the acceptable tolerances can vary by more or less than a percentage level (e.g., less than about + / - 1% dimensional tolerance). The range of some relationship between items can vary from less than a percentage level difference to several percentage differences. The range of other relationships between items can vary from several percentage differences to order of magnitude differences.
[0147] The method steps for performing the specified functions and their relationships have been described above with respect to one or more implementations by way of example. Boundaries between the functionality of the functional building blocks have been defined for the convenience of the reader in order to provide a clear implementation. Alternate boundaries can be defined for the functionality of the functional building blocks without materially changing the implementation or the intended utilization. Functional building blocks can be implemented in varying orders of dependency, and not necessarily relying on dependencies of previous functional building blocks, so long as the intended functionality of the building blocks or other implementation is upheld. Although the functional building blocks have been defined by described method steps, alternative functional building blocks can be implemented by other method steps not expressly described or illustrated. It is therefore intended that alternatives provided be within the scope of the implementations. Moreover, it is not intended that alternative functional building blocks be required to make use of the implementations. Nor is it intended that the described implementations be required to achieve the intended functionality.
[0148] The boundaries and order of the functional building blocks and the flowchart elements have been defined for the convenience of the reader in order to illustrate one or more implementations. Alternate boundaries or orders can be employed without materially changing the functionality of the implemented implementation. Additionally, the flowchart elements can be implemented in various software modules or hardware components. For example, the flowchart elements can be implemented in a single software module or multiple software modules, or a single hardware component or multiple hardware components. Further, the flowchart elements can be implemented in a computer program product tangibly embodied in a machine-readable storage medium (e.g., a non-transitory computer-readable medium) having instructions for execution by a processor.
[0149] One or more aspects, features, concepts, and / or examples have been illustrated with respect to one or more implementations herein. Physical implementations of devices, articles, machines, and / or processes can include one or more aspects, features, concepts, examples, etc. described with respect to one or more implementations discussed herein. Further, between figures and figures, implementations can incorporate identically or similarly named functions, steps, modules, etc. that can use the same, related, or unrelated reference numbers. Related features, elements, functions, operations, modules, etc. can be the same or similar functionality or can be unrelated.
Claims
1. A method for identifying anatomical features in the context of a prosthetic valve implanted at a native valve, the method comprising: identifying anatomical features based on one or more dimensions, including: (i) a distance between an upper end of the prosthetic valve and a plane of a coronary ostium; (ii) a distance between a sinus tubular junction (STJ) plane and an upper end of the prosthetic valve; (iii) a distance between the STJ plane and an upper end of a native leaflet of the native valve; (iv) a distance between the upper end of the prosthetic valve and the upper end of the native leaflet; and / or (v) a distance between the upper end of the native leaflet and the plane of the coronary ostium, wherein: the distance between the upper end of the prosthetic valve and the plane of the coronary ostium is a distance K+H, the distance between the STJ plane and the upper end of the prosthetic valve is a distance J-K, the distance between the STJ plane and the upper end of the native leaflet of the native valve is a distance J-E, the distance between the upper end of the prosthetic valve and the upper end of the native leaflet is a distance K-E, and the distance between the upper end of the native leaflet and the plane of the coronary ostium is a distance E+H; where E is a distance between an upper end of a mineral deposit and the upper end of the native leaflet, and is determined from a pre-procedure image, where H is a distance between the plane of the coronary ostium and the upper end of the mineral deposit, J is a distance between the upper end of the mineral deposit and the STJ plane, and K is a distance between the upper end of the mineral deposit and the upper end of the prosthetic valve, and wherein each of H, J, and K is determined from a procedure image / post-procedure image; wherein the pre-procedure image demonstrates a native valve within a heart vessel, and is analyzed to determine a location of the mineral deposit on the native leaflet of the native valve; wherein the procedure image / post-procedure image demonstrates the prosthetic valve implanted at the native valve, and is analyzed to identify a location of the mineral deposit within the heart vessel when the prosthetic valve has been implanted at the native valve.
2. The method of claim 1, wherein the native valve comprises an aortic valve, and the heart vessel comprises an aorta.
3. The method of claim 1, further comprising: determining, based at least in part on one or more of the dimensions, an approach to a coronary artery associated with the heart vessel.
4. The method of claim 3, wherein: determining an approach to the coronary artery is based at least in part on one or more of the K+H, K-E, and J-E distances.
5. The method of claim 4, wherein the K+H, K-E, and / or J-E distances can be indicative of an amount of space available to access the coronary artery over / through the prosthetic valve and / or over the native leaflet.
6. The method of claim 1, further comprising: identifying, based at least in part on the analysis of the pre-procedure image, a location of a coaptation leaflet within the heart vessel; determining a distal end of the native leaflet based at least in part on the position of the coaptation leaflet; and determining a distance E between the distal end of the native leaflet and the mineral deposit.
7. The method of claim 6, further comprising: determining an approach to a coronary artery associated with the heart vessel based at least in part on the distance E.
8. The method of any of claims 3-7, wherein the determined approach to the coronary artery is used to determine whether a procedure can be performed through the approach to the coronary artery after implantation of the prosthetic valve.
9. The method of claim 1, wherein analyzing the pre-procedure image to identify a location of the mineral deposit on the native leaflet comprises: generating user interface data that presents the pre-procedure image; providing the user interface data to a display device; receiving an input regarding the mineral deposit; and identifying the location of the mineral deposit based at least in part on the input.
10. The method of claim 1, wherein analyzing the pre-procedure image to identify a location of the mineral deposit on the native leaflet comprises: performing one or more image processing techniques on the pre-procedure image to identify the location of the mineral deposit on the native leaflet.