Systems and methods for anatomical feature determination - Patents.com
The method and system analyze pre- and post-treatment images to determine native valve leaflet positions and prosthetic valve placement, addressing the issue of blocked coronary access post-aortic valve replacement, enhancing the success of re-access procedures.
Patent Information
- Application Number
- JP2022547254
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2020-02-04
- Filing Date
- 2021-02-02
- Publication Date
- 2025-05-20
- Estimated Expiration
- 2041-02-02
AI Technical Summary
Aortic valve calcification leads to narrowing and stiffening, affecting blood flow and often requiring replacement with a prosthetic valve, which can displace native cusps and block access to coronary arteries, complicating re-access procedures.
A method and system for determining the position of native valve leaflets and prosthetic valves using image analysis to assess access to cardiac vessels, including pre- and post-treatment images to estimate the displacement of native cusps and blockage of coronary ostia.
Enables accurate determination of access to coronary arteries post-prosthetic valve implantation, reducing the risk of unsuccessful re-access procedures by providing data on available space and potential blockages.
Smart Images

Figure 0007680457000001 
Figure 0007680457000002 
Figure 0007680457000003
Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 62 / 970,110, filed February 4, 2020, and entitled “SYSTEMS AND METHODS FOR ANATOMICAL FEATURE DETERMINATION,” the entire contents of which are incorporated herein by reference.
[0002] The present disclosure relates to the field of medical devices and procedures. [Background technology]
[0003] 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 stiffen at the opening. If the calcification becomes severe, the aortic valve is unable to open and close properly, affecting blood flow through the valve, a condition called aortic stenosis. In some cases of aortic valve calcification or stenosis, the aortic valve needs to be replaced with an artificial valve. Summary of the Invention [Problem to be solved by the invention]
[0004] Described herein are one or more methods and / or systems for determining anatomical features. 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 representative of mineral deposits. [Means for solving the problem]
[0005] In some embodiments, the present disclosure relates to a method for determining a position of a native valve leaflet. The method can include acquiring a pre-treatment image representative of a native valve in a cardiac vessel and analyzing the pre-treatment image to determine a position of mineral deposits on the native leaflets of the native valve. The method can also include acquiring a post-treatment image representative of a prosthetic valve implanted in the native valve and analyzing the post-treatment image to identify a position of the mineral deposits in the cardiac vessel by the control circuit. Furthermore, the method can include determining, by the control circuit, a position of the native valve leaflet in the cardiac vessel. The position of the native valve leaflet can be determined based at least in part on the position of the mineral deposits on the native valve leaflet and the position of the mineral deposits in the cardiac vessel. In some implementations, the native valve includes an aortic valve and the cardiac vessel includes an aorta.
[0006] In some implementations, the method further includes determining access to a fluid vessel associated with the cardiac vessel based at least in part on a location of the native leaflets within the cardiac vessel. In some implementations, the method further includes identifying a location of at least a portion of a prosthetic valve within the cardiac vessel based at least in part on analysis of the post-procedure images. Determining access to a fluid vessel may be based at least in part on a location of at least a portion of a prosthetic valve within the cardiac vessel. Additionally, in some embodiments, the method further includes identifying a location of a coapted leaflet within the cardiac vessel based at least in part on analysis of the pre-procedure images, determining an end of the native leaflet based at least in part on the location of the coapted leaflets, and determining a distance between the end of the native leaflet and the mineral deposits. Determining access to a fluid vessel may be based at least in part on a distance between the end of the native leaflet and the mineral deposits.
[0007] In some implementations, analyzing the pre-treatment images to identify locations of mineral deposits on the native valve leaflets may include generating user interface data representing the pre-treatment images, providing the user interface data to a display device, receiving input regarding the mineral deposits, and identifying the locations of the mineral deposits based at least in part on the input. Further, in some implementations, analyzing the pre-treatment images to identify locations of mineral deposits on the native valve leaflets may include performing one or more image processing techniques using the pre-treatment images to identify locations of mineral deposits on the native valve leaflets.
[0008] In some embodiments, the present disclosure relates 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 in a cardiac vessel, generating graphical interface data representing an image of a prosthetic valve implanted in the native valve, receiving input regarding a location of the mineral representation in the image, and determining a location of the native leaflet in the cardiac vessel based at least in part on the input and the data. In some embodiments, the image includes at least one of a computed tomography image or an x-ray image of the cardiac vessel.
[0009] In some implementations, the native valve includes an aortic valve and the cardiac vessel includes an aorta. In some embodiments, the operations further include determining an amount of coronary artery access based at least in part on a location of the native valve cusps within the cardiac vessel. Further, in some embodiments, the operations further include identifying a location of at least a portion of the prosthetic valve within the aorta. Determining the amount of coronary artery access may be based at least in part on a location of at least a portion of the prosthetic valve within the aorta.
[0010] In some implementations, the data indicates a location of the mineral formation relative to ends of the native valve leaflets, and determining the location of the native valve leaflets within the cardiac vessel is based at least in part on the location of the mineral formation relative to the ends of the native valve leaflets. Further, in some implementations, the data indicates one or more characteristics of the mineral formation, and the operations further include performing one or more image processing techniques using the image to determine, based at least in part on the data, that a mineral representation in the image represents mineral formation on the native valve leaflets.
[0011] In some embodiments, the present disclosure relates to a method, the method including acquiring, by a control circuit, an image representing a prosthetic valve implanted on a native valve within a cardiac vessel, and receiving, by the control circuit, data indicative of a location of mineral formation on the native valve leaflets prior to implantation of the prosthetic valve. The method may also include analyzing the image to identify a location of mineral formation within the cardiac vessel, and determining a location of the native valve leaflets within the cardiac vessel based at least in part on the location of the mineral representation and the data.
[0012] In some implementations, the method further includes determining an amount of access to a fluid vessel associated with the cardiac vessel based at least in part on a location of the native leaflets within the cardiac vessel. In some embodiments, the method further includes identifying a location of at least a portion of the prosthetic valve within the aorta. Determining the amount of access to the fluid vessel may be based at least in part on a location of at least a portion of the prosthetic valve within the cardiac vessel. Further, in some embodiments, the method further includes identifying a location of the coapted leaflets within the cardiac vessel, determining an end of the native leaflets based at least in part on the location of the coapted leaflets, and determining a distance between the end of the native leaflets and a mineral formation. Determining the amount of access to the fluid vessel may be based at least in part on a distance between the end of the native leaflets and a mineral formation.
[0013] In some implementations, the data indicates a location of the mineral formation relative to the ends of the native valve leaflets. Determining the location of the native valve leaflets within the cardiac vessel may be based at least in part on the location of the mineral formation relative to the ends of the native valve leaflets. Further, in some implementations, analyzing the image to identify a location of the mineral deposits within the cardiac vessel includes performing one or more image processing techniques using the image to identify a location of the mineral formation within the cardiac vessel.
[0014] In some embodiments, the present disclosure relates to a method, the method including analyzing a first image to determine a location of mineral deposits on a native valve leaflet in a cardiac vessel, and analyzing a second image to identify a location of the mineral deposits in the cardiac vessel. The first image may represent a native valve, and the second image may represent a prosthetic valve. The method may also include determining coronary access based at least in part on the location of the mineral deposits on the native valve leaflet and the location of the mineral deposits in the cardiac vessel, and providing an indication indicative of a coronary access status. The indication may be based at least in part on the determined access to the coronary artery. In some implementations, the indication indicates a risk level associated with performing a procedure that includes accessing the coronary artery.
[0015] In some implementations, the indication indicates an amount of coronary artery access. In some embodiments, the method further includes determining that the amount of coronary artery access is less than a threshold and refraining from performing a procedure involving coronary artery access based at least in part on determining that the amount of coronary artery access is less than a threshold. Additionally, in some embodiments, the method further includes determining that the amount of coronary artery access is greater than a threshold and performing a procedure involving coronary artery access based at least in part on determining that the amount of coronary artery access is greater than a threshold.
[0016] For purposes of summarizing the present disclosure, certain aspects, advantages, and novel features have been described. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, the disclosed embodiments may be practiced in a manner that achieves or optimizes one advantage or advantages as taught herein, without necessarily achieving other advantages as may be taught or suggested herein.
[0017] Various embodiments are illustrated in the accompanying drawings for illustrative purposes and should not be construed as limiting the scope of the present disclosure. In addition, various features of different disclosed embodiments may be combined to form additional embodiments that are part of the present disclosure. Throughout the drawings, reference numerals may be reused to indicate correspondence between referenced elements. [Brief description of the drawings]
[0018] [Figure 1] FIG. 1 illustrates a perspective view of an exemplary heart in accordance with one or more embodiments. [Diagram 2] FIG. 1 illustrates a cross-sectional top view of an exemplary heart in accordance with one or more embodiments. [Diagram 3] FIG. 1 illustrates a cross-sectional view of an exemplary heart having mineral formation on an aortic valve, in accordance with one or more embodiments. [Figure 4] FIG. 4 is an illustrative cross-sectional view of the heart of FIG. 3 with a prosthetic valve implanted in the aortic valve, in accordance with one or more embodiments. [Diagram 5] 1 is an exemplary architecture for determining access to an anatomical feature based on analysis of one or more images representing mineral deposits, according to one or more embodiments. [Figure 6] 1A-1C are cross-sectional views of an exemplary native valve leaflet and mineral formations, according to one or more embodiments. [Figure 7] 1A-1C are cross-sectional views of an exemplary native valve leaflet, mineral formations, and prosthetic valve, according to one or more embodiments. [Figure 8A]FIG. 13 is an example flow diagram of a process for analyzing one or more images to determine the location / characteristics of anatomical features, according to one or more embodiments. [Figure 8B] FIG. 13 is an example flow diagram of a process for analyzing one or more images to determine the location / characteristics of anatomical features, according to one or more embodiments. [Figure 9] FIG. 13 is an example flow diagram of a process for providing an interface for determining the location / characteristics of an anatomical feature, according to one or more embodiments. [Figure 10] 1 is an exemplary image of a cardiac vasculature prior to implantation of a prosthetic valve, according to one or more embodiments. [Figure 11] 1 is an exemplary image of a cardiac vasculature following implantation of a prosthetic valve, according to one or more embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0019] The headings provided herein are for convenience only and do not necessarily affect the scope or meaning of the claimed subject matter.The present disclosure relates to systems, devices, and methods for determining access for anatomical features based on analysis of one or more images representative of mineral deposits.
[0020] Although some preferred embodiments and examples are disclosed below, the subject matter extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Thus, the scope of claims that may arise herefrom is not limited by any of the specific embodiments described below. For example, in any method or process disclosed herein, the acts or operations of the method or process may be performed in any suitable order, and are not necessarily limited to any particular disclosed order. Although various operations may be described in sequence as multiple separate operations in a manner that may be helpful to understand some embodiments, the order of description should not be construed to imply that these operations are order dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components. In order to compare various embodiments, some aspects and advantages of these embodiments are described. Not necessarily all such aspects or advantages are achieved by any particular embodiment. Thus, for example, various embodiments may be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein, without necessarily achieving other aspects or advantages as may be taught or suggested herein.
[0021] The term "associated with" is used herein in accordance with its broad and ordinary meaning. For example, when a first feature, element, component, device, or member is described as "associated with" a second feature, element, component, device, or member, such description should be understood as indicating that the first feature, element, component, device, or member is physically coupled, attached, connected, integrated with, at least partially embedded within, or otherwise physically associated with the second feature, element, component, device, or member, whether directly or indirectly.
[0022] overview As mentioned above, in some cases of aortic valve calcification or stenosis, it is necessary to replace the aortic valve with a prosthetic valve. Implantation of a prosthetic heart valve may involve delivering a prosthetic valve to the native valve and deploying the prosthetic valve against the valve and / or surrounding anatomical structures. For example, when a prosthetic valve is implanted into the aortic valve, the native cusps of the valve are displaced toward the aortic wall and the surrounding anatomical structures. In some cases, one or more native cusps may completely or partially block the coronary ostia, blocking access to the coronary arteries. In the future, access to the coronary arteries may be required to perform other procedures (sometimes referred to as "re-access procedures") on the heart or surrounding anatomical structures. For example, in some re-access procedures, a physician may navigate a device, such as a scope or catheter, through the aorta to the aortic valve and attempt to navigate through the coronary ostia into the coronary arteries. However, the physician may not realize that the native cusps have been displaced by the prosthetic valve to the extent that they are blocking access to the coronary arteries. Such a blockage may result in an unsuccessful re-access procedure and / or a failure to perform the re-access procedure, given the likelihood of success.
[0023] The present disclosure describes techniques and systems for determining access for anatomical features based on the analysis of one or more images representing mineral deposits. In some embodiments, the techniques can estimate the location of a native valve after a prosthetic valve is implanted therein. For example, the techniques can analyze pre-treatment images of the native valve to determine the location of mineral deposits on the native valve leaflets, such as calcium deposits on the native valve leaflets. Following implantation of the prosthetic valve, the techniques can analyze post-treatment images of the prosthetic valve to identify the location of mineral deposits within the heart valve area. Based on the location of mineral deposits on the native valve leaflets (as determined from the pre-treatment images) and the location of mineral deposits within the heart valve area (as identified from the post-treatment images), the techniques can estimate the location of the native valve leaflets after implantation of the prosthetic valve. Such information can be used to determine the amount of access (e.g., available space) to blood vessels located in close proximity to the native valve, such as the coronary arteries.
[0024] In many embodiments, the techniques and systems are discussed in the context of calcium and / or phosphate formation on valves, such as in aortic calcification / stenosis, however, the techniques and systems can be applied to a variety of situations, such as other mineral and / or anatomical features.
[0025] Exemplary Cardiac Anatomy 1 and 2 illustrate an exemplary heart 100 having various features relevant to certain aspects of the present disclosure. In particular, FIG. 1 illustrates a perspective view of the heart 100, and FIG. 2 illustrates a cross-sectional top view of the heart 100. The heart 100 includes four chambers: a left ventricle 102, a left atrium 104, a right ventricle 106, and a right atrium 108. A muscular wall, called the septum, separates the left chamber from the right chamber. In particular, an atrial septal wall portion separates the left atrium 104 from the right atrium 108, while an interventricular septal wall portion separates the left ventricle 102 from the right ventricle 106. A lower end 110 of the heart 100, called the apex, is generally located on or near the clavicular midline in the fifth intercostal space.
[0026] The heart 100 includes four valves to aid in the circulation of blood therein. A heart valve may generally include a relatively dense fibrous ring, referred to herein as the annulus, as well as multiple leaflets or cusps attached to the annulus. Generally, the leaflets or cusps may be sized and positioned such that, as the heart contracts, the resulting increased blood pressure generated within the corresponding heart chamber forces the leaflets at least partially open, allowing flow from the heart chamber. When pressure within a heart chamber decreases, pressure within the subsequent heart chamber or vessel may prevail and push the leaflets back. As a result, the leaflets / cusps appose each other, thereby closing off the flow path.
[0027] Surrounding the ventricles (102, 106) are numerous arteries 112 (sometimes referred to as "coronary arteries 112") that supply oxygenated blood to the heart muscle, and numerous veins (not shown) that return blood from the heart muscle to the right atrium 108 via the coronary sinus, a relatively large vein that extends generally around the top of the left ventricle 102 and provides a return conduit for blood returning to the right atrium 108.
[0028] The left ventricle 102 is the primary pumping chamber of the heart 100. A healthy left ventricle is generally longer (relative to a transverse axis extending at its widest point between the opposing walls of the left ventricle 102) than it is wide (relative to the mean electrical axis of the heart 100) and is generally conical or apical in shape, in that it descends from a base 114 to a point or apex 110 where the cross-sectional diameter and / or circumference decreases. In general, the apical region of the heart 100 can be considered the bottom region of the heart 100, located within the left and / or right ventricular regions, but distal to the mitral valve 202 and tricuspid valve 204, and disposed toward the apex 110 of the heart.
[0029] The pumping of blood from the left ventricle 102 is accomplished by squeezing and twisting or torsional motions. The squeezing motion occurs between the lateral wall of the left ventricle 102 and the septum. The twisting motion is the result of contraction of myocardial fibers that extend in a roughly circular or spiral direction around the heart 100. As these fibers contract, a gradient of angular displacement of the myocardium from the apex 110 to the base 114 about the mean electrical axis of the heart 100 is produced. The resultant force vector extends at an angle of approximately 30-60 degrees relative to the flow of blood through the aortic valve 208 and the ascending aorta 116. Contraction of the heart 100 manifests as a counterclockwise rotation of the apex 110 relative to the base 114 when viewed from the apex 110 (i.e., an inferior view of the heart 100). Contractions of the heart 100, in conjunction with the filling volumes of the left atrium 104 and ventricle 102, respectively, can result in relatively high fluid pressures on the left side of the heart 100, at least during certain phases of the cardiac cycle.
[0030] The primary role of the left chambers 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 to transport blood to other regions of the heart 100. The left atrium 104 receives oxygenated blood from the lungs via the pulmonary veins. Oxygenated blood collected from the pulmonary veins in the left atrium 104 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 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 around the lungs. There, fresh oxygen enters the bloodstream and the blood travels to the left side of the heart 100 via a network of pulmonary veins that eventually end in the left atrium 104. In FIG. 1, a portion of the pulmonary trunk has been removed (ie, shown by the dotted line) to expose the left coronary artery 112(A).
[0031] The valves of the heart 100 include a tricuspid valve 204 that separates the right atrium 108 from the right ventricle 106. The tricuspid valve 204 may generally have three valve points or leaflets and may generally close during ventricular contraction (i.e., systole) and open during ventricular expansion (i.e., diastole). The valves of the heart 100 further include a pulmonary valve 206 that separates the right ventricle 106 from the pulmonary artery 120 and may be configured to open during systole to allow blood to be pumped towards the lungs and to close during diastole to prevent blood from leaking from the pulmonary artery 120 back into the heart 100. The pulmonary valve 206 generally has three leaflets / cusps and may each have a crescent shape. The heart 100 also includes a mitral valve 202 that generally has two leaflets / cusps and separates the left atrium 104 from the left ventricle 102. The mitral valve 202 may generally be configured to open during diastole to allow blood in the left atrium 104 to flow into the left ventricle 102 and close during systole to prevent blood from leaking back into the left atrium 104. Additionally, the heart 100 includes an 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 may have a crescent shape. The aortic valve 208 is configured to open during systole to allow blood exiting the left ventricle 102 to enter the aorta 116 and close during diastole to prevent blood from leaking back into the left ventricle 102.
[0032] Atrioventricular (i.e., mitral and tricuspid) heart valves are generally associated with a subvalvular apparatus that includes a collection of chordae tendineae and papillary muscles that secure the leaflets of the respective valves to promote and / or facilitate proper coaptation of the leaflets and prevent their prolapse. For example, the papillary muscles may generally include finger-like projections from the ventricular wall. The chordae tendineae generally prevent the leaflets from opening in the wrong direction, thereby preventing blood from flowing back into the left atrium 104.
[0033] With further reference to the anatomy of the aorta 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 may pass through a pericardial sheath common to the pulmonary trunk. At the root of the ascending aorta, the vessel lumen may generally present three relatively small pockets (i.e., the aortic sinuses or "sinuses of Valsalva") between the cusps of the aortic valve 208 and the wall of the aorta 116. The left aortic sinus contains the origin of the left coronary artery 112(A) (also referred to as "LCA 112(A)"), and the right aortic sinus similarly originates from the right coronary artery 112(B) (also referred to as "RCA 112(B)"). The posterior aortic sinus does not give rise to a coronary artery.
[0034] 2 illustrates various features associated with the coronary arteries 112. As discussed above, the left coronary artery 112(A) and the right coronary artery 112(B) originate from the aortic sinus. The left coronary artery 112(A) originates above the left cusp 208(A) (also referred to as "left cusp 208(A)") of the aortic valve 208, and the right coronary artery 112(B) originates above the right cusp 208(B) (also referred to as "right cusp 208(B)") of the aortic valve 208. The root of the aorta 116 includes coronary ostia 210 that connect to the coronary arteries 112, with the left coronary ostia 210(A) located above the left cusp 208(A) and the right coronary ostia 210(B) located above the right cusp 208(B).
[0035] Exemplary aortic valve calcification and prosthetic valves 3 and 4 show cross-sectional views of a heart 100 having mineral formations on an aortic valve 208, according to one or more embodiments. As used herein, the term "mineral formation" or "mineral deposit" may generally refer to one or more minerals embedded in and / or attached to an anatomical feature. For example, in FIGS. 3 and 4, calcium and / or phosphate are embedded in and / or attached to the aortic valve 208, such as on or within the leaflets of the aortic valve 208. Although many exemplary embodiments are discussed in the context of calcium and / or phosphate formations on the aortic valve, other types of mineral formations may occur on the aortic valve and / or other valves / anatomical features.
[0036] In the example of FIG. 3 and FIG. 4, the aortic valve 208 includes relatively severe calcification (e.g., aortic stenosis) and the aortic valve 208 needs to be replaced with a prosthetic valve 402 (shown in FIG. 4). In some embodiments, the prosthetic valve 402 may be implanted in the aortic valve 208 by performing a minimally invasive procedure. For example, a physician may make a relatively small incision (e.g., below a threshold size) in the patient, such as in the patient's leg or chest, to access the patient's anatomical lumen, such as an artery or vein. The physician may advance a catheter-based device into the anatomical lumen (e.g., femoral vein / artery, inferior vena cava, etc.) and navigate the catheter-based device to the implantation site, i.e., the aortic valve 208. Using the catheter-based device or another device (e.g., a balloon catheter), the physician may deploy the prosthetic valve 402 in the aortic valve 208 to replace the native aortic valve 208. In some embodiments, such procedures include transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI) procedures using transcatheter access. Although some embodiments are discussed in the context of implanting a prosthetic valve using transcatheter access, the prosthetic valve may be implanted using other procedures, such as more invasive procedures involving cutting into the heart (e.g., to implant a surgical prosthetic valve).
[0037] In any case, when implanting the prosthetic valve 402, the leaflets of the aortic valve 208 may be displaced toward the aortic wall, as shown in FIG. 4. For example, the prosthetic valve 402 may expand radially, pushing the leaflets of the aortic valve 208 toward the aortic wall. In other words, the size / diameter of the prosthetic valve 402 may vary to provide an outward radial force, displacing the leaflets of the aortic valve 208 toward the aortic wall. Once implanted, the prosthetic valve 402 may continue to provide an outward radial force, maintaining the leaflets of the aortic valve 208 in the position shown in FIG. 4. In some cases, with the native leaflets of the aortic valve 208 displaced toward the aortic wall, the native leaflets may limit access to the coronary arteries (not shown in FIGS. 3 and 4). That is, the native leaflets may obstruct access from the aorta 116 to the coronary arteries 112 via the coronary ostia 210.
[0038] The prosthetic valve 402 (sometimes referred to as "prosthetic heart valve 402") can include various types of prosthetic valves, such as catheter-based prosthetic valves (e.g., transcatheter heart valves (THVs)), surgical prosthetic valves, etc. In some embodiments, the prosthetic valve 402 is configured to be radially compressed into a compressed state for delivery through the patient's vasculature. The prosthetic valve 402 can be configured to self-expand to a natural, uncompressed, or functional state having a preset diameter once placed at a desired location within the patient's vasculature.
[0039] In some embodiments, the prosthetic valve 402 can include a support frame, which may include a lattice-like framework, such as a stent, configured to secure the prosthetic valve 402 within or adjacent to a defective annulus of the heart 100. The support stent structure can provide additional stability and prevent the prosthetic valve 402 from migrating after it is implanted. 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 chrome, and / or a polymer. Additionally, the support stent structure can have configurations other than those shown in FIG. 4. For example, the support stent structure can have a different shape, more or fewer vertical support bars, and / or additional structures for additional stability. In some embodiments, the support stent structure can include a strut mesh and / or a sleeve structure.
[0040] In some embodiments, the support stent structure can be secured to the leaflet assembly. The leaflet assembly can include multiple leaflets that collectively function as a one-way valve by joining together. For example, with respect to a prosthetic aortic valve, the leaflet assembly can include three leaflets. However, it will be appreciated that the prosthetic valve can have a greater or lesser number of leaflets. The various components of the leaflet assembly can be formed in whole or in part from any suitable biomaterial or polymer, such as, for example, polyethylene terephthalate (PET), ultra-high molecular weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE), etc.
[0041] Exemplary Architecture 5 illustrates an exemplary architecture 500 for determining access to anatomical features based on analysis of one or more images representative of mineral deposits, according to one or more embodiments. The architecture 500 includes one or more imaging devices 502 (referred to as "imaging devices 502" for ease of discussion) configured to capture / generate one or more images of a patient 504, and one or more computing systems 506 (referred to as "computing systems 506" for ease of discussion) configured to evaluate the one or more images to determine access to anatomical features associated with the patient 504. The imaging devices 502 and computing systems 506 can be configured to communicate, such as to transmit / receive data including one or more images and / or any other data created by the imaging devices 502, over one or more networks 508. The computing systems 506 can be configured to receive input from and / or provide output to a user, such as a physician, technician, radiologist, etc.
[0042] In some embodiments, the imaging device 502 can be configured to generate one or more pre-treatment images of the patient 504 prior to implantation of the prosthetic valve and provide the one or more pre-treatment images to the computing system 506. The computing system 506 can interface with a physician or operate independently to determine the location / characteristics of one or more mineral formations on the native valve based on the one or more pre-treatment images. Following or during implantation of the prosthetic valve, the imaging device 502 can be configured to generate one or more treatment or post-treatment images of the patient 504 and provide the one or more treatment or post-treatment images to the computing system 506. The computing system 506 can interface with a physician or operate independently to identify the location of one or more mineral formations within the cardiac vessel. Additionally, the computing system 506 can use the pre-treatment data indicative of the location of the one or more mineral formations to determine the location of the native valve within the cardiac vessel, which may generally be a displaced location due to implantation of the prosthetic valve. Additionally, the computing system 506 can determine the location of the prosthetic valve within the cardiac vessel. Based on the location of the native valve and / or prosthetic valve, the computing system 506 can determine the amount of space available to access fluid vessels within cardiac vasculature, such as coronary arteries.
[0043] Although the computing system 506 and the imaging device 502 are described in many embodiments as performing both pre-treatment and post-treatment processing, the computing system 506 and / or the imaging device 502 may be implemented as one or more devices / systems capable of performing pre-treatment and / or post-treatment processing. In some embodiments, a first computing system and / or imaging device may be used to perform pre-treatment processing, while a second computing system and / or imaging device may be used to perform post-treatment processing. Additionally, in some embodiments, the imaging device 502 and the computing system 506 are located in the same facility / environment / location, while in other embodiments, the imaging device and the computing system 506 are located in separate facilities / environments / locations.
[0044] The computing system 506 may be implemented as one or more computing devices, such as one or more desktop computers, laptop computers, servers, smartphones, electronic reader devices, mobile handsets, personal digital assistants, portable navigation devices, portable gaming devices, tablet computers, wearable devices (e.g., wristwatches, optical head mounted displays, etc.), portable media players, televisions, set-top boxes, in-vehicle computer systems, appliances, cameras, security systems, home-based computer systems, projectors, medical monitors, etc. In some embodiments, the one or more computing devices are configured in a cluster, data center, cloud computing environment, or combinations thereof. Additionally, in some embodiments, the one or more computing devices are implemented as remote computing resources located away from the imaging device 502. In other embodiments, the one or more computing devices are implemented as local resources located locally in the environment of the imaging device 502.
[0045] As shown, the computing system 506 may include one or more of the following components, devices, modules, and / or units (referred to herein as "components"): a control circuit 510, one or more I / O components 512, one or more network interfaces 514, and / or a data storage / memory 516, separately / individually and / or in combination / collectively. Although several components of the computing system 506 are shown in FIG. 5, it should be understood that additional components not shown may be included in embodiments according to the present disclosure. Furthermore, in some embodiments, some of the illustrated components may be omitted. Although the control circuit 510 is shown as a separate component in the diagram of FIG. 5, it should be understood that any or all of the remaining components of the computing system 506 may be embodied, at least in part, in the control circuit 510. That is, the control circuitry 510 may include various devices (active and / or passive), semiconductor materials and / or areas, layers, regions, and / or portions thereof, conductors, leads, vias, connections, etc., and one or more of the other components of the computing system 506 and / or portions thereof may be at least partially formed and / or embodied in / by such circuit components / devices.
[0046] The various components of the computing system 506 may be electrically and / or communicatively coupled using a number of connecting circuits / devices / functionality that may or may not be part of the control circuitry 510. For example, the connecting functionality may 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 may be electrically and / or communicatively coupled to one another.
[0047] The one or more I / O components 512 may include various components for receiving input and / or providing output, such as for interfacing with a user. The one or more I / O components 512 may be configured to receive touch, speech, gestures, or any other type of input. Additionally, the one or more I / O components 512 may 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 may include one or more displays (sometimes referred to as "one or more display devices"), touch screens, touch pads, 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 based on an audio signal), microphones (e.g., configured to receive sound and generate audio signals), cameras, etc. The one or more displays may 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 of technology. In some embodiments, the one or more displays include one or more touch screens configured to receive input and / or display data.
[0048] The one or more network interfaces 514 may be configured to communicate with one or more devices / systems over one or more networks 508. For example, the one or more network interfaces 514 may transmit / receive data wirelessly and / or wired over the network, such as one or more images captured by the imaging device 502. The one or more networks 508 may include one or more local area networks (LANs), wide area networks (WANs) (e.g., the Internet), personal area networks (PANs), body area networks (BANs), etc. In some embodiments, the one or more network interfaces 514 may implement wireless technologies such as Bluetooth, Wi-Fi, near field communications (NFC), etc.
[0049] As shown, the memory 516 may include a characterization component 518, a graphical user interface component 520, and / or an image processing component 522 configured to facilitate various functions described herein. In some embodiments, one or more of the components 518-522 may include and / or be implemented as one or more executable instructions that, when executed by the control circuitry 510, cause the control circuitry 510 to perform one or more operations. Although many embodiments are described in the context of the components 518-522 including one or more instructions executable by the control circuitry 512, any of the components 518-522 may be implemented at least in part 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 program specific standard products (ASSPs), one or more complex programmable logic devices (CPLDs), etc. Additionally, although components 518-522 are shown as being included within computing system 506, any of components 518-522 may be implemented at least partially within another device / system, such as imaging device 502 and / or another device / system. Similarly, any of the other components of computing system 506 may be implemented at least partially within another device / system.
[0050] The characterization component 518 can be configured to identify one or more anatomical features and / or properties / locations of one or more anatomical features. For example, the characterization component 518 can evaluate one or more pre-treatment images captured by the imaging device 502 and / or stored in the image data store 524. The one or more pre-treatment images can represent one or more features of the patient 504 before a medical device is implanted in the patient 504, such as before a prosthetic valve is implanted in a cardiac vessel. Evaluation of the one or more pre-treatment images can determine one or more properties / locations of one or more anatomical features in the patient 504. For example, the feature determination component 518 can determine characteristics / locations of the native leaflets (e.g., location of the native leaflets within the cardiac vessel, length of the leaflets, distance from the end of the leaflets to a particular plane, location of the end of the native leaflets based on the coapted leaflets, etc.), characteristics / locations of mineral deposits (e.g., location of mineral deposits on the native leaflets, dimensions of mineral deposits, etc.), characteristics / locations of anatomical structures surrounding the native leaflets (e.g., diameter of coronary arteries, diameter of aorta, distance of coronary ostia from the annulus plane and base, etc.), characteristics / locations of coapted leaflets (e.g., location of coapted leaflets), etc. The feature determination component 518 can store data indicative of such characteristics / locations in the anatomical feature data store 526 (sometimes referred to as "pre-treatment data").
[0051] Additionally, the characterization component 518 can evaluate one or more treatment or post-treatment images captured by the imaging device 502 and / or stored in the image data store 524. The one or more treatment or post-treatment images can represent one or more characteristics of the patient 504 while the medical device is implanted in the patient 504 and / or after the medical device is implanted, such as after a prosthetic valve is implanted in a cardiac vessel. Evaluation of the one or more treatment or post-treatment images can determine one or more characteristics / locations of one or more anatomical features in the patient 504 during / after the treatment. For example, the characterization component 518 can determine one or more characteristics / locations related to the aortic annular / valve region, such as characteristics / locations of the native valve leaflets during / after the treatment, characteristics / locations of mineral deposits on the native valve leaflets during / after the treatment, characteristics / locations of anatomical structures surrounding the native valve leaflets during / after the treatment, amount of access to the anatomical features during / after the treatment (e.g., amount of access to the coronary arteries). The feature determination component 518 can store data indicative of such characteristics / locations in the anatomical feature data store 526 (sometimes referred to as "treatment data" or "post-treatment data").
[0052] In evaluating one or more treatment or post-treatment images, the characterization component 518 can reference data stored in the anatomical feature data store 526, such as pre-treatment data. For example, the characterization component 518 can identify calcium representations in the post-treatment images and determine that the calcium representations correspond to particular calcium deposits on the native valve leaflets based on the pre-treatment data indicating characteristics of the particular calcium deposits (e.g., dimensions of the calcium deposits). In addition, the characterization component 518 can also determine the location of the native valve leaflets within the cardiac vessel based on the pre-treatment data, which can indicate the location of the calcium deposits on the native valve leaflets, such as the distance from the end of the native valve leaflets to the calcium deposits. In addition, the characterization component 518 can determine the amount of access to the fluid vessel located proximate to the native valve leaflets (e.g., determine how much the location of the native valve leaflets blocks access to the fluid vessel). For example, it can determine whether there is enough space around the native valve leaflets (which may currently be partially covering the coronary ostium) for a medical device to access the coronary arteries from the aorta.
[0053] In some embodiments, the feature determination component 518 can evaluate one or more pre-treatment, treatment, and / or post-treatment images to identify anatomical features that are visible / represented in the one or more images, such as walls, calcium deposits, coapted leaflets, cavities, and / or other anatomical features that are visible / represented. Based on the identification of such visible / represented anatomical features, the feature determination component 518 can determine properties / locations of the visible / represented anatomical features. Additionally, the feature determination component 518 can identify hidden / unrepresented anatomical features and / or properties / locations of hidden / unrepresented anatomical features based on the properties / locations of the visible / represented anatomical features. The feature determination component 518 can store the properties / locations for the represented and / or unrepresented anatomical features in the anatomical feature data store 526.
[0054] In some embodiments, the characterization component 518 can evaluate multiple pre-treatment, treatment, and / or post-treatment images from different orientations / positions / angles. For example, the characterization component 518 can identify one or more characteristics / locations of an anatomical feature by analyzing a first image from a first orientation / position within the patient and a second image from a second orientation / position within the patient.
[0055] Exemplary characteristics / locations of one or more anatomical features may include characteristics / locations of native leaflets (e.g., thickness / length / width / shape of native leaflets, location of native leaflets in a cardiac vessel, distance from an end of the native leaflets to a particular plane, location of the end of the native leaflets based on the coapted leaflets, 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 in a cardiac vessel, etc.), characteristics / locations of fluid vessels (e.g., diameter of coronary arteries, diameter of aorta / aortic root, etc.), characteristics / locations of orifices (e.g., location of coronary ostia in the aortic annulus region and / or relative to the native leaflets / prosthetic valve, etc.), and / or any other characteristics / dimensions. In some embodiments, the location of an anatomical feature is represented / illustrated in terms of a dimension such as distance to another anatomical feature, distance to a prosthetic valve, distance to a mineral formation, etc. Additionally, in some embodiments, the location of an anatomical feature may include one or more coordinates of the anatomical feature in a coordinate system / space.
[0056] In some embodiments, the one or more characteristics / locations of the anatomical feature may include one or more characteristics / locations of a device implanted in the anatomical feature, such as the size / shape / location of a prosthetic valve implanted in the human body structure. Additionally, in some embodiments, the one or more characteristics / locations of the anatomical feature may include one or more characteristics / locations of a mineral formation attached and / or embedded in the anatomical feature. Additionally, in some embodiments, the one or more characteristics / locations of the anatomical feature may include a characteristic / location of a visual representation of the anatomical feature in an image, such as the size of the visual representation, the color / shade of the visual representation, the location of the visual representation in the image, etc.
[0057] 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 an 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 valve cusp, a coronary artery, an aortic wall, etc. In another example, the user can provide input requesting that a first point / location on the image and a second point / location in the image be designated and 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 an example, the user can provide input to determine / label any of the exemplary dimensions discussed in FIG. 6 and FIG. 7. In an example, the feature determination component 518 can use the input provided by the user to evaluate one or more images and / or store data regarding one or more characteristics / locations of one or more anatomical features in the anatomical feature data store at 526.
[0058] Further, 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 using one or more images to automatically identify image-based features in 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 uses 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 use information determined by the image processing component 522 to evaluate the one or more images and / or store data regarding the properties / locations of one or more anatomical features in an anatomical feature data store at 526.
[0059] In some embodiments, one or more of the components 518-522 evaluate one or more images to identify anatomical features that may not generally be visible / represented in one or more images. For example, a native valve leaflet may not be visible / represented in a cardiovascular image due to characteristics of the native leaflet (e.g., size / dimensions of the native leaflet), characteristics of the imaging device 502 (e.g., detectable resolution of the imaging device 502), etc. To illustrate, the imaging device 502 may be configured to detect anatomical features that are larger than a certain size / thickness, and the native leaflet may be smaller than that certain size / thickness. In some embodiments, the native leaflet may not be detected due to the proximity of the native leaflet to a prosthetic valve that may have a larger size than the native leaflet, and / or other characteristics that would cause the imaging device 502 to detect a stronger signal from the prosthetic valve. That is, the signal from the prosthetic valve may be stronger than the signal from the native leaflet, preventing the native leaflet from being detected.
[0060] In some embodiments, a single leaflet may not be visible / represented in the image, but the coapted leaflet may be visible / represented in the image. The location / characteristics of the coapted leaflet may be used to determine the tip / end of the native leaflet. For example, one or more of components 518-522 may evaluate the image to identify the coapted leaflet and determine the characteristics / location of the coapted leaflet and / or other anatomical features within the cardiovascular system, such as the distance from mineral deposits to the tip of the native leaflet (i.e., the coapted leaflet).
[0061] The data / information generated / determined herein can be used in a variety of ways. In some embodiments, data regarding the characteristics / locations of anatomical features can be used to determine whether a procedure, such as a re-access procedure, can be performed. For example, the computing system 506 can generate data indicative of the amount of access to the coronary arteries after implantation of a prosthetic valve in the aortic valve. Such data can be used to determine whether a medical device, such as a catheter, can access the coronary arteries from the aorta. In an example, it can be determined that there is sufficient space to access the coronary arteries with a medical device if the amount of space available is 2-3 times greater than the diameter of the medical device. In an example, access to the coronary arteries can be performed above / around / through the prosthetic valve, such as through the frame of the prosthetic valve, and / or above / around the native valve leaflets. In an example, data regarding the amount of access to anatomical features, such as the coronary arteries, can be provided to a user, such as a physician, technician, or patient, to assist the user in making decisions regarding the likelihood of success in performing a procedure after implantation of a prosthetic valve and / or in selecting a suitable patient for the procedure. In an example, such information can be displayed to the user via a user interface.
[0062] 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 device should access the coronary arteries from the aorta. This 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 after a procedure to initially implant a prosthetic valve and / or to reposition a prosthetic valve. Such data can assist in positioning or repositioning a prosthetic valve in an appropriate location to minimize blockage to the coronary arteries and / or other anatomical features. Additionally, in some embodiments, data regarding the characteristics / locations of anatomical features can be used to implant additional prosthetic valves 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 multiple patients and used to determine metrics for multiple patients, such as the average location of the native valve leaflets, the average amount of space available to access the fluid vessels, etc. In an example, such metrics can be provided to a user to assist in making decisions regarding the performance of the procedure.
[0063] As described above, the image data store 524 can store one or more images, such as pre-treatment, treatment, and / or post-treatment 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 the characteristics / locations of pre-treatment, treatment, and / or post-treatment 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 shown 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.
[0064] The imaging device 502 may 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 thermography (IRT) devices, positron emission tomography (PET) devices, and / or other types of medical imaging devices. The imaging device 502 may be configured to capture / generate one or more images that generally include visual representations of internal anatomical structures, such as organs / tissues / other anatomical features of the patient. In some embodiments, the imaging device 502 captures / generates one or more images from different orientations / angles of the patient 504. This allows the anatomy of the patient 504 to be viewed at different slices of data and / or from different orientations. The imaging device 502 may be configured to generate two-dimensional (2D) images, three-dimensional (3D) images, models, and / or the like. In some embodiments, contrast agents or other substances are used to assist in the capture / generation of the images. For example, the patient may be required to ingest a substance containing a contrast agent to assist the imaging device 502 in capturing / producing an image.
[0065] As shown, the imaging device 502 may 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 storage / memory 532, one or more I / O components 534, and one or more imaging components 536, separately / individually and / or in combination / collectively. Although several components of the imaging device 502 are shown in FIG. 5, it should be understood that additional components not shown may be included in embodiments according to the present disclosure. Furthermore, in some embodiments, some of the illustrated components may be omitted. Although the control circuit 528 is shown as a separate component in the diagram of FIG. 5, it should be understood that any or all of the remaining components of the imaging device 502 may be embodied, at least in part, in the control circuit 528. That is, the control circuitry 528 may include various devices (active and / or passive), semiconductor materials and / or areas, layers, regions, and / or portions thereof, conductors, leads, vias, connections, etc., and one or more of the other components of the imaging device 502 and / or portions thereof may be at least partially formed and / or embodied in / by such circuit components / devices.
[0066] The various components of the imaging device 502 may be electrically and / or communicatively coupled using a number of connecting circuits / devices / functionality that may or may not be part of the control circuitry 528. For example, the connecting functionality may 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 imaging device 502. In some embodiments, two or more of the control circuitry 528, the one or more network interfaces 530, the data storage / memory 532, the one or more I / O components 534, and / or the one or more imaging components 536 may be electrically and / or communicatively coupled to one another.
[0067] The one or more network interfaces 530 may be configured to communicate with one or more devices / systems over one or more networks 508. For example, the one or more network interfaces 530 may transmit / receive data wirelessly and / or wired over the network, such as one or more images. In some embodiments, the one or more network interfaces 530 may implement wireless technologies such as Bluetooth, Wi-Fi, Near Field Communication (NFC), etc.
[0068] The one or more I / O components 534 may include various components for receiving input and / or providing output, such as for interfacing with a user. The one or more I / O components 534 may be configured to receive touch, speech, gestures, or any other type of input. Additionally, the one or more I / O components 534 may 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 may include one or more displays (sometimes referred to as "one or more display devices"), touch screens, touch pads, 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 based on an audio signal), microphones (e.g., configured to receive sound and generate audio signals), cameras, etc. The one or more displays may 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 of technology. In some embodiments, the one or more displays include one or more touch screens configured to receive input and / or display data.
[0069] The one or more imaging components 536 may include generators, sensors, detectors, cameras, etc. configured to provide / generate and / or receive / detect signals / radiation and may be used to capture / generate one or more images. In some embodiments, the imaging device 502 may include structure for holding the patient 504 and / or moving the patient 504 into proximity of the one or more imaging components 536.
[0070] As used herein, the term "control circuit" is used in its broad and ordinary sense and refers to any set of one or more processors, processing circuits, processing modules / units, chips, dies (e.g., semiconductor dies including one or more active and / or passive devices and / or connection circuits), 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 circuits, analog circuits, digital circuits, and / or any device that operates on signals (analog and / or digital) based on circuitry and / or hard coding of operational instructions. The control circuit can further include one or more storage devices that can be embodied within a single memory device, multiple memory devices, and / or the 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. Note that in embodiments where the control circuit includes a hardware state machine (and / or implements a software state machine), data storage devices / registers that store any associated operational instructions can be embedded within or external to the circuit including the state machine, analog circuit, digital circuit, and / or logic circuit.
[0071] 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, non-volatile, removable, and / or non-removable data storage devices implemented using any technology, layout, and / or data structures / protocols that contain any suitable or desired computer-readable instructions, data structures, program modules, or other types of data.
[0072] Computer-readable media that can be implemented according to 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 disk read-only memory (CD-ROM), digital versatile disk (DVD) or other optical storage, magnetic cassette, magnetic tape, magnetic disk storage or other magnetic storage device, or any other non-transitory medium that can be used to store information for access by a computing device. As used in some contexts herein, computer-readable media may 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.
[0073] Exemplary Cardiovascular 6 and 7 illustrate cross-sectional views of exemplary anatomical features and anatomical feature characteristics / locations, according to one or more embodiments. In particular, FIGS. 6 and 7 illustrate anatomical features associated with the aorta 602, namely, the aortic annulus / valve region, including the native leaflets 604 attached to the aortic annulus 606 at their ends 608, and the coronary arteries 610 fluidly connected to the aorta 602 via the coronary ostia 612. As illustrated, the native leaflets 604 include calcium deposits 614 embedded and / or attached to the native leaflets 604. In these examples, the coronary artery 610 is the left coronary artery, which in some cases may be at higher risk of occlusion during prosthetic valve implantation, as compared to the right coronary artery. However, it should be understood that the discussion regarding the left coronary artery 610 is equally applicable to the right coronary artery (not shown), another type of fluid vessel, and / or any other anatomical feature. FIG. 6 shows the native valve leaflets 604 in a pre-procedure state without a prosthetic valve 702 implanted in the aortic valve, and FIG. 7 shows the native valve leaflets 604 in a post-procedure state with a prosthetic valve 702 implanted in the aortic valve.
[0074] In some embodiments, the techniques and systems discussed herein can evaluate one or more pre-treatment images representing the anatomical features shown in FIG. 6 to identify anatomical features visible / represented in the one or more pre-treatment images, such as the aortic wall, calcium deposits 614, leaflet tips / ends (e.g., based on coapted leaflets), coronary arteries 610, and / or other anatomical features visible / represented. In some examples of evaluating one or more pre-treatment images, native leaflet tips / ends can be identified when a leaflet coapts with another leaflet, such as during closure / diastole. Based on identifying anatomical features visible / represented in one or more pre-treatment images, the techniques and systems can determine characteristics / locations of the visible / represented anatomical features (and / or hidden / unrepresented anatomical features), the location being expressed in one or more dimensions.
[0075] FIG. 6 illustrates several example dimensions (which may represent / identify the location of anatomical features) that may be determined for one or more pre-treatment images, including the distance / dimension A between the plane 618 of the annulus and the plane 620 of the coronary ostium 612 (also referred to as the “inferior plane 620”), the distance / dimension B between the plane 622 of native leaflet coaptation and the plane 624 of native commissure, the diameter / dimension C of the coronary artery 610 (which may represent the diameter of the left coronary artery 610 proximate its ostium 612), the distance / dimension D between the upper end of the calcium deposit 614 and the bottom surface 620 of the coronary ostium 612, the distance / dimension E between the upper end 616 of the calcium deposit 614 and the end 616 of the leaflet 604, the distance / dimension F between the plane 618 of the annulus and the plane 622 of native leaflet coaptation, and / or the distance / dimension G between the upper end of the calcium deposit 614 and the plane 618 of the annulus.
[0076] 6, if the upper end of the calcium deposit 614 is located below the plane 620 of the coronary ostium 612 during diastole, the distance D may be associated with an identifier indicating such (e.g., a positive sign (+)). Further, if the upper end of the calcium deposit 614 is located above the plane 620 of the coronary ostium 612 during diastole, the distance D may be associated with an identifier indicating such (e.g., a negative sign (-)).
[0077] 7 illustrates an example of the aortic valve of FIG. 6 with a prosthetic valve 702 implanted. In particular, the prosthetic valve 702 is expanded to an implanted / deployed state in the aortic valve. As shown, the native valve leaflets 604 are repositioned to a substantially straight and vertical position. Here, the native valve leaflets 604 and / or the prosthetic valve 702 at least partially block the coronary ostium 612.
[0078] In some embodiments, the techniques and systems discussed herein can evaluate one or more treatment / post-treatment images representative of the anatomical features shown in Figure 7 to identify anatomical features visible / represented in the one or more images, e.g., aortic wall, calcium deposits 614, coronary arteries 610, prosthetic valves 710, and / or other anatomical features visible / represented. Based on identifying anatomical features visible / represented in the one or more treatment / post-treatment images, the techniques and systems can determine characteristics / locations of the visible / represented anatomical features (and / or hidden / non-represented anatomical features), the positioning expressed in one or more dimensions.
[0079] FIG. 7 shows several example dimensions (which may represent / identify the location of anatomical features) that may be determined for one or more treatment / post-treatment images, including the distance / dimension 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 / dimension I between the frame of the prosthetic valve 702 and the center of the coronary ostium 612, the distance / dimension J between the plane 704 of the upper end of the calcium deposit 614 and the sinotubular junction (STJ) plane 706, and / or the distance / dimension K between the plane 704 of the upper end of the calcium deposit 614 and the upper end 708 of the prosthetic valve 702.
[0080] In some embodiments, if the upper end of the calcium deposit 614 is located below the plane 620 of the coronary ostium 612 after deployment of the prosthetic valve 702, the distance H may be associated with an identifier indicating such (e.g., a positive sign (+)). Further, if the upper end of the calcium deposit 614 is located above the plane 620 of the coronary ostium 612 after deployment of the prosthetic valve 702, as shown in FIG. 7, the distance H may be associated with an identifier indicating such (e.g., a negative sign (-)). Further, in some embodiments, when the prosthetic valve 702 is implanted, the position of the upper end / tip of the native valve leaflet 604 approaches the position of the center of the coronary ostium 612.
[0081] In some embodiments, the techniques and systems discussed herein can determine one or more additional dimensions to represent / identify anatomical features with the implanted prosthetic valve 702 based on one or more of the dimensions discussed above with reference to FIG. 6 and / or FIG. 7, including, for example, the distance / dimension KH between the upper end 708 of the prosthetic valve 702 and the plane 620 of the coronary ostium 612 (i.e., distance K plus distance H), the distance / dimension JK between the STJ plane 706 and the upper end 708 of the prosthetic valve 702 (i.e., distance J minus distance K), the distance / dimension JE between the STJ plane 706 and the upper end / tip 616 of the native valve 604 (i.e., distance J minus distance E), the distance / dimension KE between the upper end 708 of the prosthetic valve 702 and the upper end 616 of the native leaflet 604 (i.e., distance K minus distance E), and / or the distance / dimension EH between the upper end 616 of the native leaflet 604 and the plane 620 of the coronary ostium 612 (i.e., distance E plus distance H).
[0082] In some embodiments, the techniques and systems discussed herein can use one or more of the dimensions discussed above to determine the amount of access to the coronary artery 620. For example, the distances KH, KE, and / or JE can indicate the amount of space available to access the coronary artery 610 over / through the prosthetic valve 702 and / or over the native valve cusps 604. In other words, the distances KH, KE, and / or JE can indicate how much the prosthetic valve 702 and / or the native valve cusps 604 obstruct the coronary ostium 612 to the coronary artery 610. Such information can be useful in determining whether implantation of the prosthetic valve 702 allows a procedure to be performed with access through the coronary artery 610. When the prosthetic valve 702 is implanted in the aortic valve (as shown in FIG. 7), the amount of access to the coronary artery 610 is reduced compared to an aortic valve without a prosthetic valve (as shown in FIG. 6). Although distances KH, KE, and / or JE are discussed in the examples, one or more other dimensions may be used in determining the amount of space available to access the coronary artery 610.
[0083] 6 and 7, although other dimensions may additionally or alternatively be determined. In some embodiments, the techniques and systems discussed herein may use one or more algorithms to determine the distance / dimension associated with an anatomical feature, for example, an algorithm that converts the number of pixels in an image or the distance between pixels to the distance / dimension of the anatomical feature.
[0084] Exemplary Flow Diagram 8A, 8B, and 9 illustrate example flow diagrams of processes for performing one or more techniques described herein. Various blocks associated with the processes may be performed by one or more devices / systems, users, etc. For example, one or more of the blocks may be performed by control circuitry of the computing system 506 and / or the imaging device 502, and / or may be performed by a physician, technician, and / or any other user.
[0085] 8A-8B show an example flow diagram of a process 804 for analyzing one or more images to determine the location / characteristics of an anatomical feature, according to one or more embodiments. In FIG. 8A, at block 802, the process 800 can include acquiring one or more first images representing a native valve in a cardiac vessel. In some embodiments, the control circuitry of the device / system can receive one or more pre-treatment images from an imaging device. The one or more pre-treatment images can include data representing a cardiac vessel, such as an aortic valve in an aortic annulus region. Additionally, in some embodiments, a user can acquire / receive one or more pre-treatment images from an imaging device, a computing system, and / or another device / system.
[0086] At block 804, the process 800 may include analyzing the one or more first images to determine one or more characteristics / locations of one or more mineral formations. In an example, the characteristics of the mineral formation may include a size / shape / dimension of the mineral formation. Further, in an example, the location of the mineral formation may include a location of the mineral formation relative to an anatomical feature such as a tip / end or another portion of a native valve leaflet, a coronary artery, an aortic wall, a coordinate system / space, etc.
[0087] In some embodiments, as shown in block 806, the control circuitry can perform one or more image processing techniques using the one or more pre-treatment 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, which attempts to identify one or more image features (e.g., edges, corners, blobs, ridges, etc.) in the image, tracking, which attempts to track one or more image features across images / frames, and / or classification, which attempts to classify one or more image features into one or more categories. In an example, the one or more image processing techniques can use one or more models, such as a machine-trained model, a user-trained model, or another model trained to classify image features (e.g., image features representative of mineral formations). In some embodiments, the control circuitry can determine any of the dimensions described with reference to FIG. 6 and FIG. 7.
[0088] Further, in some embodiments, as shown in block 806, the control circuitry can provide a user interface to a user and / or receive input regarding one or more characteristics / locations of one or more mineral formations. For example, the control circuitry can generate user interface data representing a user interface including a pre-treatment image and / or transmit user interface data to a display device for display of a user interface including the pre-treatment image. A user can view the pre-treatment image through an interface and provide input identifying a location of a mineral formation. In one example, a user can designate a representation / location in the image as representing a mineral formation. In another example, a user can designate a first point / location on the image and a second point / location on the image and provide input requesting that a distance between the first point / location and the second point / location be calculated. The first point / location and / or the second point / location can be on or near the mineral representation. Thus, the distance can indicate the location of the mineral formation relative to another feature. In some embodiments, a user can select various points / locations on the image to designate (and / or have the control circuitry determine) any of the dimensions described with reference to FIG. 6 and FIG. 7.
[0089] In some embodiments, the control circuitry and / or user can identify the tips / ends of the native leaflets based on coapted leaflets (i.e., leaflets that are touching or in close proximity to each other). For example, the control circuitry and / or user can identify an area in the image that is associated with a particular shade / color / size typically associated with coapted leaflets. The control circuitry and / or user can designate the area of the coapted leaflets as the tips / ends of the native leaflets. In an example, the control circuitry and / or user can determine the location of the mineral formation relative to the tips / ends of the native leaflets, such as the distance between the location of the mineral formation and the tips / ends of the native leaflets.
[0090] At block 810, process 800 may include generating pre-treatment data indicative of one or more characteristics / locations of the one or more mineral formations. In some embodiments, the control circuitry may generate pre-treatment data indicative of one or more characteristics / locations of the one or more mineral formations based on the characteristics / locations determined / identified at block 804. Once generated, the pre-treatment data may be stored in a data store, such as a data store associated with the control circuitry and / or located on a network.
[0091] At block 812, the process 800 may include acquiring one or more second images representative of the prosthetic valve implanted in the native valve. In some embodiments, the control circuitry may receive one or more treatment / post-treatment images from the imaging device. The one or more treatment / post-treatment images may include data representative of a prosthetic valve in a cardiovascular vessel, such as a prosthetic aortic valve deployed in an aortic valve. Additionally, in some embodiments, a user may acquire / receive one or more treatment / post-treatment images from the imaging device, a computing system, and / or another device / system.
[0092] At block 814, process 800 may include obtaining pre-treatment data. In some embodiments, the control circuitry may retrieve the pre-treatment data from a data store, which in some cases may be located on a network. In an example, the pre-treatment data may indicate one or more characteristics / locations of one or more mineral formations prior to implantation of the prosthetic valve. Additionally, in some embodiments, a user may obtain / receive the pre-treatment data.
[0093] In FIG. 8B, at block 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 the prosthetic valve.
[0094] In some embodiments, as indicated at block 818, the control circuitry may perform one or more image processing techniques using the one or more treatment / post-treatment images to determine one or more characteristics / locations of one or more mineral formations, which may include one or more of the techniques described above with reference to block 806. In an example, the control circuitry may obtain pre-treatment data indicative of characteristics of the mineral formations / pre-treatment mineral representations, such as size / shape / color of the mineral formations and / or size / shape / color of a visual representation representing the mineral formations in the pre-treatment images. The control circuitry may use the pre-treatment data to identify mineral representations in the treatment / post-treatment images that have one or more similar characteristics (e.g., satisfying one or more similarity thresholds) as the mineral formations / mineral representations in the pre-treatment images.
[0095] Further, in some embodiments, the control circuitry can perform one or more image processing techniques using one or more treatment / post-treatment images to determine one or more characteristics / locations of the prosthetic valve. For example, the control circuitry can identify one or more representations in the post-treatment image as corresponding to one or more elements of the prosthetic valve if the one or more representations are arranged along a substantially perpendicular plane / axis, are connected to one another via one or more connection representations, have characteristics of a typical prosthetic valve, etc. In an example, the control circuitry can reference a library of prosthetic valve data to identify characteristics of the prosthetic valve, such as a typical frame size / shape or another feature of the prosthetic valve.
[0096] Further, in some embodiments, as also shown in block 818, the control circuitry can provide a user interface to a user and / or receive input regarding one or more mineral formations and / or one or more characteristics / locations of the prosthetic valve. For example, the control circuitry can generate user interface data representing a user interface including the treatment / post-treatment images and / or transmit the user interface data to a display device for display of the user interface. The user can view the treatment / post-treatment images via the interface and can provide input identifying the location of the mineral formations and / or the location of the prosthetic valve, similar to one or more of the techniques described above with reference to block 806. In an example, the user interface can display information regarding the pre-treatment images and / or the mineral formations within the pre-treatment images to assist the user in identifying the mineral formations within the treatment / post-treatment images.
[0097] At block 820, the process 800 may include determining a position of the native valve within the cardiac vessel. In some embodiments, the control circuitry and / or the user may determine the position of the native valve / cusp within the cardiac vessel based on the position of the mineral formations on the native valve leaflets prior to implantation of the prosthetic valve (which may be shown in the pre-treatment data) and / or the position of the mineral formations within the cardiac vessel after implantation of the prosthetic valve. In an example, the position / orientation of the native valve leaflets may be estimated based on the position of one or more mineral formations and / or the position of the prosthetic frame. For example, if multiple mineral formations and / or frame elements of the prosthetic valve are identified in a substantially perpendicular plane / axis, the native valve leaflets may be estimated to be substantially parallel to and / or within a distance to the perpendicular plane / axis.
[0098] At block 822, the process 800 may include determining access to a fluid vessel associated with the cardiac vessel. For example, the control circuitry and / or user may determine an amount of access to a fluid vessel associated with the cardiac vessel based on a location of the native valve within the cardiac vessel after implantation of the prosthetic valve, a location of the prosthetic valve within the cardiac vessel, etc. The amount of access may indicate available space over the native valve leaflets and / or the prosthetic valve, and / or through a portion of the prosthetic valve that is above the native valve leaflets. In some embodiments, the control circuitry may determine one or more of the dimensions shown in FIG. 6 and / or FIG. 7 and use the one or more dimensions to determine an amount of available space, such as between the tip / end of the native valve leaflet and a portion of the aortic wall that is substantially above the tip / end of the native valve leaflet, between the top end of the prosthetic valve and a portion of the aortic wall that is substantially above the end of the prosthetic valve, etc.
[0099] Additionally, in some embodiments, the control circuitry can provide treatment / post-treatment images to a user interface, and a user can provide input to select the top of the mineral formation and select a portion of the aortic wall. The user can provide input requesting that a distance between the top of the mineral formation and the portion of the aortic wall be calculated. The control circuitry can determine such distance and use that distance, as well as any other distances, to determine the amount of access space.
[0100] At block 824, process 800 may include generating data indicative of one or more characteristics / locations of the native valve and / or prosthetic valve. For example, the control circuitry may generate data indicative of one or more characteristics / locations of the native valve / cusps and / or prosthetic valve after implantation of the prosthetic valve within a cardiac vessel. In some embodiments, the data may also indicate an amount of access to a fluid vessel, such as a dimension indicative of an amount of access to the fluid vessel. The control circuitry may store the data in a data store.
[0101] At block 826, the process 800 can include providing an indication indicating an access status of the fluid vessel, such as a coronary access status. In some examples, an indication can be provided indicating a risk / risk level associated with performing a procedure that includes accessing a fluid vessel (e.g., high / medium / low risk that there is a block to the coronary artery due to implantation of a prosthetic valve and / or the position of the native valve leaflets). For example, the indication can indicate that the access to the coronary artery is fully blocked, partially blocked, open (e.g., not blocked), etc. The indication can be based on and / or indicate the amount of access to the fluid vessel. In some embodiments, the indication is provided to the user via a display or other output device, such as a visual / audio representation. However, the indication can be provided in other ways. In some embodiments, the patient can be associated with an indication indicating the access status of the fluid vessel.
[0102] At block 828, the process 800 may include performing a procedure including accessing the fluid vessel or refraining from performing a procedure. In some embodiments, the process 800 may include determining that the amount of access to the coronary artery is below a threshold and / or that the risk / risk level is a particular value (e.g., a relatively high risk of a block to the coronary artery) and, based on such a determination, refraining from performing a procedure including accessing the coronary artery. Alternatively or additionally, the process 800 may include determining that the amount of access to the coronary artery is above a threshold and / or that the risk / risk level is a particular value (e.g., a relatively low risk of a block to the coronary artery) and, based on such a determination, performing a procedure including accessing the coronary artery.
[0103] One or more of blocks 802-828 may be performed at various times. In some embodiments, one or more of blocks 802-810 may be performed before the prosthetic valve is implanted, and one or more of blocks 812-828 may be performed after the prosthetic valve is implanted. Additionally, in some embodiments, one or more of blocks 802-810 may be performed after the prosthetic valve is implanted. For example, one or more pre-procedure images taken before the prosthetic valve is implanted may be analyzed after the prosthetic valve is implanted. However, blocks 802-828 may be performed at other times and / or in any order.
[0104] 9 illustrates an example flow diagram of a process 900 for providing an interface for determining a location / characteristic of an anatomical feature, according to one or more embodiments. At block 902, the process 900 can include receiving data indicative of a location / characteristic of a mineral formation. For example, the control circuitry can retrieve pre-treatment data from a data store. In some embodiments, the pre-treatment data can indicate one or more characteristics / locations of one or more mineral formations prior to implantation of the prosthetic valve, for example, a location of the mineral formation relative to the ends / tips of the native valve leaflets.
[0105] At block 904, the process 900 may include generating graphical interface data representing an image of the prosthetic valve implanted on the native valve. For example, the control circuitry may generate user interface data representing a user interface including treatment / post-treatment images of the prosthetic valve implanted on the native valve.
[0106] At block 906, process 900 may include providing graphical interface data to a display device. For example, the control circuitry may transmit the graphical interface data to the display device to display a user interface including the treatment / post-treatment images. In some embodiments, the display device is a component of a computing system in which the control circuitry is located, and in other embodiments, the display device is a component of another computing system.
[0107] At block 908, process 900 may include receiving input regarding locations / characteristics of mineral representations within the images. For example, the control circuitry may receive input via a user interface regarding locations / characteristics of mineral representations shown in the treatment / post-treatment images, such as input identifying locations of mineral formations, dimensions associated with mineral formations, etc.
[0108] At block 910, the process 900 may include performing one or more image processing techniques using the images. For example, the control circuitry may perform one or more image processing techniques using the treatment / post-treatment images to determine that a mineral representation in the image represents mineral formation on a native valve leaflet. In an example, the one or more image processing techniques may use data indicative of one or more characteristics of the mineral formation.
[0109] At block 912, process 900 may include determining the location of the native valve and / or prosthetic valve within the cardiac vessel. For example, the control circuitry may determine the location of the native valve / valve leaflets within the cardiac vessel based on the input received at block 908, the image processing performed at block 910, and / or pre-treatment data indicative of the location / characteristics of mineral formations.
[0110] At block 914, the process 900 may include determining access to a fluid vessel associated with a cardiac vessel. For example, the control circuitry may determine an amount of access to a coronary artery based on a position of a native valve / valve leaflet and / or a position of at least a portion of a prosthetic valve within the cardiac vessel.
[0111] Example images 10 and 11 show exemplary pre-treatment images 1000 and post-treatment images 1100, respectively, that may be generated by an imaging device according to one or more embodiments. In these examples, images 1000 and 1100 represent CT or X-ray images showing various anatomical features within the aortic valve region. For example, images 1000 and 1100 show an aortic valve 1002 located between a left ventricle 1004 and an aorta 1006, and a coronary artery 1008 located above the aortic valve 1002. FIG. 10 shows the aortic valve region in a pre-treatment state without a prosthetic valve 1102, while FIG. 11 shows the aortic valve region with a prosthetic valve 1102 implanted to replace the aortic valve 1002. Although the native leaflets of the aortic valve 1002 may not generally be visualized / represented in a CT or X-ray image, for ease of illustration, the native leaflets of the aortic valve 1002 are shown in FIGS. 10 and 11 with dotted lines.
[0112] In these examples, the aortic valve 102 includes calcium deposits 1010, which may appear as white representations (e.g., lighter areas) in the images 1000 and 1100. The calcium deposits 1010 may include specific characteristics / locations that may enable the calcium deposits 1010 to be detected by an imaging device. For example, the calcium deposits 1010 may each have a size that meets a size / thickness threshold associated with detection by an imaging device. Although the calcium deposits 1010 are shown in these examples as attached to the apexes of the native leaflets of the aortic valve 1002, the calcium deposits 1010 may be attached / embedded beneath and / or within the native leaflets.
[0113] As shown in FIG. 10, the pre-treatment image 1000 also includes a slightly darker region 1012 indicative of the coapted leaflets. The coapted leaflets may include certain characteristics / locations that may allow the coapted leaflets to be detected by the imaging device. For example, the coapted leaflets may include two or more native leaflets that may be in contact with or close to each other, creating a substantially thicker region than the native leaflets alone, so that the coapted leaflets may meet a size / thickness threshold associated with detection by the imaging device. The region 1012 may generally represent the end / tip of the native leaflet of the aortic valve 1002. Thus, while the native leaflets of the aortic valve 1002 may generally not be visible / represented in the pre-treatment image 1000, the tip / end of the native leaflet of the aortic valve 1000 may be visible / represented (e.g., in the darker region 1012) when the native leaflet is coapted with another leaflet.
[0114] In some embodiments, the systems and techniques discussed herein can analyze the pre-treatment image 1000 of FIG. 10 to identify features that are visible / represented in the pre-treatment image 1000 and / or determine one or more characteristics / locations of the visible / represented and / or hidden / not represented features. For example, the systems and techniques can identify calcium deposits 1010, regions 1012 representing tips / ends of native leaflets of the aortic valve 1002, the aortic wall, coronary arteries 1008, and / or other anatomical features. The systems and techniques can also determine characteristics related to such features, such as location of the feature, size / shape of the feature, etc. In some embodiments, the systems and techniques can use the location of the calcium deposits 1010 to estimate the location of the native leaflets of the aortic valve 1002. For example, the location of the native leaflets of the aortic valve 1002 can be estimated to be below / above / below the calcium deposits 1010. Data regarding the characteristics / location of the calcium deposits 1010 and / or the estimated characteristics / location of the native leaflets of the aortic valve 1002 (and / or other information) may be stored as pre-treatment data.
[0115] As mentioned above, Fig. 11 shows a post-procedure image 1100 showing an aortic valve region having a prosthetic valve 1102 implanted to replace the aortic valve 1002, where the native leaflets of the aortic valve 1002 are pushed towards the aortic wall and coronary artery 1008 by the radially outward force exerted by the prosthetic valve 1002. The frame of the prosthetic valve 1102 may generally have a size / thickness that meets a size / thickness threshold associated with detection by the imaging device, and thus the frame of the prosthetic valve 1102 may be detected by the imaging device and represented in the post-procedure image 1100. As shown in Fig. 11, the frame of the prosthetic valve 1102 is shown in a white representation (e.g., representing multiple frame elements / portions).
[0116] In some embodiments, the systems and techniques discussed herein can analyze the post-treatment image 1100 of FIG. 11 to identify features that are visible / represented in the post-treatment image 1100 and / or determine one or more characteristics / locations of the visible / represented and / or hidden / not represented features. For example, the systems and techniques can identify calcium deposits 1010, the aortic wall, the coronary arteries 1008, frame elements of the prosthetic valve 1102, and / or other anatomical features. The systems and techniques can also determine characteristics related to such features, such as the location of the features, the size / shape of the features, etc. In some embodiments, the systems and techniques can use the location of the calcium deposits 1010 in the pre-treatment image 1000 to estimate the location of the native leaflets of the aortic valve 1002 and / or the access to the coronary arteries 1008 (e.g., the amount of access to the coronary arteries 1008). Data regarding the characteristics / location of the calcium deposits 1010 and / or the estimated characteristics / location of the native leaflets of the aortic valve 1002 and / or the estimated access (and / or other information) can be stored as post-procedure data. In some embodiments, the systems and techniques discussed herein can map the likelihood of sinus isolation.
[0117] Additional Features and Embodiments The above description of the embodiments of the present disclosure is not intended to be exhaustive or to limit the present disclosure to the precise form disclosed above. Although specific embodiments and examples have been described above for illustrative purposes, various equivalent modifications are possible within the scope of the present disclosure, as one skilled in the art will recognize. For example, while processes or blocks are presented in a given order, alternative embodiments may perform routines having steps or use systems having blocks in a different order, and some processes or blocks may be deleted, moved, added, subdivided, combined, and / or modified. Each of these processes or blocks may 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 may instead be performed in parallel or at different times.
[0118] Several terms of location are used herein with respect to various disclosed embodiments. Although several spatially relative terms such as "outer", "inner", "upper", "lower", "lower", "upper", "vertical", "horizontal", "top", "bottom" and similar terms are used herein to describe the spatial relationship of one device / element or anatomical structure to another device / element or anatomical structure, it should be understood that these terms are used herein for ease of description to describe the positional relationship between the elements / structures as shown in the drawings. The spatially relative terms are intended to encompass different orientations of the elements / structures in use or operation in addition to the orientation shown in the drawings. For example, an element / structure described as "above" another element / structure can represent a position that is below or beside such other element / structure with respect to the intended patient or alternative orientations of the element / structure, and vice versa.
[0119] Conditional language used herein, e.g., "can," "could," "might," "may," "for example," and the like, is intended in its ordinary sense unless otherwise indicated or understood as used within the context, and is intended to convey that, generally, some embodiments include certain features, elements, and / or steps, while other embodiments do not. Thus, such conditional language is not intended to imply that features, elements, and / or steps are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining, with or without author input or prompting, whether those features, elements, and / or steps are included in or should be performed in any particular embodiment.
[0120] It should be understood that some order terms (e.g., "first" or "second") may be provided for ease of reference and do not necessarily imply physical characteristics or order. Thus, as used herein, order terms (e.g., "first," "second," "third," etc.) used to modify elements such as structures, components, operations, etc., do not necessarily indicate a priority or order of the element with respect to any other elements, but rather, generally allow the element to be distinguished from another element having a similar or identical name (however order terms may be used). In addition, indefinite articles ("a" and "an") used herein may indicate "one or more" rather than "one". Furthermore, an action that is performed "based on" a condition or event may also be performed based on one or more other conditions or events not explicitly listed. In some contexts, a description of an action or event occurring or being performed "based on" or "at least in part based on" a stated event or condition may be interpreted as being triggered by or being performed in response to the stated event or condition.
[0121] Although a particular order of operations or steps has been illustrated and / or described with respect to the various methods and processes disclosed herein, it should be understood that the various steps and operations illustrated and described may be performed in any suitable or desired temporal order. Further, any of the illustrated and / or described operations or steps may be omitted from any given method or process, and the illustrated / described methods and processes may include additional operations or steps not explicitly illustrated or described.
[0122] In the above description of the embodiments, it should be appreciated that various features may be grouped together in a single embodiment, figure, or description thereof to streamline the disclosure and aid in understanding one or more of the various aspects of the disclosure. However, this method of disclosure should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Furthermore, any component, feature, or step illustrated and / or described in a particular embodiment herein may be applied to or used with any other embodiment. Furthermore, no component, feature, step, or group of components, features, or steps is necessary or essential to each embodiment. Thus, it is intended that the scope of the present disclosure should not be limited by the particular embodiments described above, but should be determined solely by a fair reading of the claims that follow.
[0123] Unless the context clearly requires otherwise, throughout the specification and claims, the words "comprise," "comprising," "have," "having," "include," "including," and the like are intended to be interpreted in an open, inclusive sense, i.e., "including but not limited to," as opposed to a closed, exclusive, or exhaustive sense.
[0124] The term "coupled," as used generally herein, refers to two or more elements that can be physically, mechanically, and / or electrically connected or otherwise associated, whether directly or indirectly (e.g., through one or more intermediate elements, components, and / or devices). Additionally, as used herein, the terms "herein," "above," "below," and terms of similar import shall refer to this application as a whole, including any disclosure incorporated by reference, and not to any particular portions of this disclosure. Where the context permits, terms in this disclosure using the singular or plural number can also include the plural or singular number, respectively.
[0125] The word "or," in reference to a list of two or more items, includes all of the following interpretations of that word: any of the items in the list, all of the items in the list, and any combination of the items in the list. Additionally, as used herein, the term "and / or" used between elements (e.g., between the last two of a list of elements) means any one or more of the referenced / associated elements. For example, the phrase "A, B, and / or C" means "A," "B," "C," "A and B," "A and C," "B and C," or "A, B, and C."
[0126] The terms "substantially" and "about" may be used herein to provide an industry-accepted tolerance for its corresponding term and / or relativity between items. In some industries, the industry-accepted tolerance may be less than 1 percent, while in other industries, the industry-accepted tolerance may be 10 percent or more. Other examples of industry-accepted tolerances range from less than 1 percent to 50 percent. 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 tolerances of the accepted tolerances may be greater or smaller than the percentage level (e.g., dimensional tolerances of less than about + / -1%). Some relativities between items may range from less than the percentage level to a few percent difference. Other relativities between items may range from a few percent difference to the magnitude of the difference.
[0127] One or more embodiments have been described above with method steps illustrating the performance of certain functions and their relationships. The boundaries and sequences of these functional building blocks and method steps have been arbitrarily defined herein for convenience of description. Alternative boundaries and sequences can be defined as long as the specified functions and relationships are properly performed. Thus, any such alternative boundaries or sequences are within the scope and spirit of the claims. Furthermore, the boundaries of these functional building blocks have been arbitrarily defined herein for convenience of description. Alternative boundaries can be defined as long as some important functions are properly performed. Similarly, blocks in the flow diagrams have also been arbitrarily defined herein to illustrate certain important functions.
[0128] To the extent used, the flow diagram block boundaries and sequences could have been defined otherwise and still perform some significant functionality. Thus, such alternative definitions of both functional units, flow diagram blocks, and sequences are within the scope and spirit of the claims. Those skilled in the art will also recognize that the functional units and other example blocks, modules, and components herein can be implemented as shown, or by discrete components, application specific integrated circuits, processors executing appropriate software, or the like, or any combination thereof.
[0129] One or more embodiments are used herein to illustrate one or more aspects, one or more features, one or more concepts, and / or one or more examples. A physical embodiment of an apparatus, an article of manufacture, a machine, and / or a process may include one or more of the aspects, features, concepts, examples, etc. described with reference to one or more of the embodiments discussed herein. Furthermore, between figures, the embodiments may incorporate the same or similarly named functions, steps, modules, etc., which may use the same reference numbers, related reference numbers, or unrelated reference numbers. Related features, elements, functions, operations, modules, etc. may be of the same or similar functionality, or may be unrelated. [Explanation of symbols]
[0130] 100 Heart 102 Left ventricle 104 Left atrium 106 Right ventricle 108 Right atrium 110 Bottom end 112 Coronary Arteries 114 Base 116 Ascending aorta 118 Inferior vena cava 120 Superior Vena Cava 202 Mitral Valve 204 Tricuspid Valve 206 Pulmonary valve 208 Aortic Valve 402 Artificial valves 500 Architecture 502 Imaging Device 504 patients 506 Computing Systems 508 Network 510 Control circuit 512 I / O Components 514 Network Interface 516 Data Storage / Memory 518 Characterization Component 520 Graphical User Interface Components 522 Image Processing Component 524 Image Data Store 526 Anatomical Features Data Store 528 Control Circuit 530 Network Interface 532 Data Storage / Memory 534 I / O Components 536 Imaging Components 602 Aorta 604 Natural leaflet 606 Aortic valve annulus 608 End 610 Coronary Arteries 612 Coronary Ostium 614 Calcium deposits 616 Upper end 618 plane 620 plane 622 plane 624 Natural commissural plane 702 Artificial valves 704 plane 706 plane 708 Top 1000 Pre-Treatment Images 1002 Aortic valve 1004 Left ventricle 1006 Aorta 1008 Coronary Artery 1010 Calcium deposits 1012 area 1100 Post-treatment image 1102 Artificial valve
Claims
1. 1. A method of operating a control circuit to determine a position of a native valve leaflet, comprising: the control circuitry acquiring a pre-treatment image representative of a native valve within a cardiac vessel; the control circuitry analyzing the pre-treatment images to determine a location of mineral deposits on the native leaflets of the native valve; identifying, based at least in part on analysis of the pre-treatment images by the control circuitry, a location of a coapted leaflet within the cardiac vessel, the coapted leaflet including two or more native leaflets that may be in contact or proximity with one another, creating a thicker region than a single native leaflet; the control circuit determining a position of an end of the native leaflet as being at the identified position of the coaptation leaflet; the control circuit determining a distance between the end of the native valve leaflet and the mineral deposit; the control circuitry acquiring a post-procedure image representative of a prosthetic valve implanted onto the native valve; the control circuitry analyzing the post-treatment images to identify a location of the mineral deposits within the cardiac vessel; the control circuitry determines a position of the native valve leaflet within the cardiac vessel based at least in part on the position of the mineral deposit on the native valve leaflet, the distance between the edge of the native valve leaflet and the mineral deposit, and the position of the mineral deposit within the cardiac vessel; The method includes:
2. 2. The method of claim 1, wherein the native valve comprises an aortic valve and the cardiovascular vessel comprises an aorta. and determining whether the control circuitry has access to a fluid vessel associated with the cardiac vessel based at least in part on the position of the native valve leaflets within the cardiac vessel.
3. The method of claim 1 or 2, further comprising: and determining whether or not the prosthetic valve is located within the cardiac vessel based at least in part on the analysis of the post-procedure images. and wherein the step of determining access to the fluid vessel is based at least in part on the location of at least the portion of the prosthetic valve within the cardiac vessel. The method of claim 3.
5. determining access to the fluid vessel based at least in part on the distance between the edge of the native valve leaflet and the mineral deposits; The method of claim 3.
6. 20. The method of claim 19, further comprising: analyzing the pre-treatment images to identify the location of the mineral deposits on the native valve leaflets, generating user interface data representative of the pre-treatment image; providing the user interface data to a display device; receiving input regarding the mineral deposit; identifying the location of the mineral deposit based at least in part on the input; 6. The method according to any one of claims 1 to 5, comprising:
7. 20. The method of claim 19, further comprising: analyzing the pre-treatment images to identify the location of the mineral deposits on the native valve leaflets, performing one or more image processing techniques using the pre-treatment images to identify the location of the mineral deposits on the native valve leaflets.
7. The method of claim 1 , comprising:
8. A control circuit; communicatively coupled to the control circuitry, and when executed by the control circuitry, causing the control circuitry to receiving data indicative of a location of mineral formation on a native leaflet of a native valve within a cardiac vessel, the data including a location of a coapted leaflet within the cardiac vessel, a distance between an end of the native leaflet and the mineral formation, and a location of the mineral formation relative to the end of the native leaflet, the coapted leaflet including two or more native leaflets that may be in contact or proximity with one another creating a thicker area than a single native leaflet, and a location of the end of the native leaflet based on the location of the coapted leaflets; generating graphical interface data representing an image of a prosthetic valve implanted in the native valve; receiving an input regarding a location of a mineral representation within the image; determining a position of the native valve leaflet within the cardiac vessel based at least in part on the input, the distance between the end of the native valve leaflet and the mineral formation, the position of the mineral formation relative to the end of the native valve leaflet, and the data; a memory storing executable instructions for performing operations including A computing system comprising:
9. The computing system of claim 8 , wherein the images include at least one of a computed tomography image or an x-ray image of the cardiovascular vessels.
10. 10. The computing system of claim 8 or 9, wherein the native valve comprises an aortic valve and the cardiovascular system comprises an aorta.
11. The operation, determining an amount of coronary artery access based at least in part on the location of the native valve leaflets within the cardiac vessel; 11. The computing system of claim 8, further comprising:
12. The operation, Identifying a location of at least a portion of the prosthetic valve within the aorta.
12. The computing system of claim 11, further comprising: wherein the determining the amount of access to the coronary artery is based at least in part on the position of at least the portion of the prosthetic valve within the aorta.
13. the data being indicative of one or more characteristics of the mineral formation, and the operation comprising: performing one or more image processing techniques using the image to determine, based at least in part on the data, that the mineral representation in the image represents the mineral formation on the native valve leaflets.
13. The computing system of claim 8, further comprising:
14. A method of operating a control circuit, comprising the steps of: the control circuit acquiring an image representative of a prosthetic valve implanted in a native valve within a cardiovascular vessel; receiving, by the control circuitry, data indicative of a location of mineral formation on a native valve leaflet prior to implantation of the prosthetic valve; the control circuitry analyzing the images to identify a location of the mineral formation within the cardiac vessel; the control circuit identifying a location of a coapted leaflet within the cardiac vessel, the coapted leaflet including two or more native leaflets that may be in contact or proximity to one another, creating a thicker region than a single native leaflet; the control circuit determining a position of an end of the native leaflet as being at the identified position of the coaptation leaflet; the control circuit determining a distance between the edge of the native valve leaflet and the mineral formation; the control circuitry determines a position of the native valve leaflet within the cardiac vessel based at least in part on the location of the mineral formation on the native valve leaflet, the distance between the edge of the native valve leaflet and the mineral formation, and the data; The method includes:
15. The control circuitry determining an amount of access to a fluid vasculature associated with the cardiac vessel based at least in part on the position of the native valve leaflets within the cardiac vessel.
15. The method of claim 14, further comprising:
16. The control circuitry identifying a location of at least a portion of the prosthetic valve within the cardiac vessel. and wherein the determining the amount of access to the fluid vessel is based at least in part on the location of at least the portion of the prosthetic valve within the cardiac vessel. The method of claim 15.
17. The method of claim 16, wherein the step of determining the amount of access to the fluid vessel is based at least in part on the distance between the end of the native valve leaflet and the mineral formation. The method of claim 15.
18. 18. The method of any one of claims 14 to 17, wherein the data indicates a position of the mineral formation relative to an end of the native valve leaflet, and wherein the step of determining the position of the native valve leaflet within the cardiovascular vessel is based at least in part on the position of the mineral formation relative to the end of the native valve leaflet.
19. 20. The method of claim 19, further comprising: performing one or more image processing techniques using the image to identify the location of the mineral formation within the cardiac vessel.
19. The method of any one of claims 14 to 18, comprising:
20. A method of operating a control circuit, comprising the steps of: analyzing a first image, the first image representing a native valve, to determine a location of mineral deposits on a native valve leaflet within a cardiac vessel; identifying, based at least in part on analysis of the first image by the control circuitry, a location of a coapted leaflet within the cardiac vessel, the coapted leaflet including two or more native leaflets that may be in contact or proximity with one another, creating a thicker region than a single native leaflet; the control circuit determining a position of an end of the native leaflet as being at the identified position of the coaptation leaflet; the control circuit determining a distance between the end of the native valve leaflet and the mineral deposit; analyzing a second image, the second image representing a prosthetic valve, to identify a location of the mineral deposit within the cardiac vessel, the control circuitry analyzing the second image representing a prosthetic valve; the control circuitry determining coronary access based at least in part on the location of the mineral deposits on the native valve leaflets, the distance between the edge of the native valve leaflets and the mineral deposits, and the location of the mineral deposits within the cardiac vessel; the control circuitry providing an indication indicative of a coronary artery access status, the indication being based at least in part on the determined access to the coronary artery; The method includes:
21. 21. The method of claim 20, wherein the indication indicates a risk level associated with performing a procedure that involves accessing the coronary artery.
22. the indication indicating an amount of access to the coronary artery, the method comprising: the control circuit determining that the amount of access to the coronary artery is less than a threshold; refraining from performing a procedure involving accessing the coronary artery based at least in part on the control circuitry determining that the amount of access to the coronary artery is less than the threshold; 22. The method of claim 20 or 21, further comprising:
23. the indication indicating an amount of access to the coronary artery, the method comprising: the control circuit determining that the amount of access to the coronary artery is greater than a threshold; performing a procedure including accessing the coronary artery based at least in part on the control circuitry determining that the amount of access to the coronary artery is greater than the threshold; and 22. The method of claim 20 or 21, further comprising:
24. A control circuit; a memory communicatively coupled to said control circuitry and storing executable instructions that, when executed by said control circuitry, cause said control circuitry to perform each step of the method of any one of claims 1 to 7 and claims 14 to 23; A computing system comprising:
Citation Information
Patent Citations
Analyzing aortic valve calcification
JP2017532085A