System, computer program and computer program product for planning, preparing, monitoring and / or executing of a clinical intervention for implanting a cardiac valve

Abstract

The present invention relates to a system a computer program and a computer program product for automatic planning and / or preparing of a clinical intervention for implanting a cardiac valve in a patient. The system (100) comprises an input interface (101) for entering data and a computing unit (102). Said computing unit (102) is adapted to receive input data via the input interface (101). The input data comprise patient data (201) relating to characteristics of the patient, cardiac valve data (202) relating to the orientation of a prosthetic cardiac valve (202) with respect to a delivery tool (401) to be used for implantation and / or with respect to a loading tool (402) for loading the prosthetic cardiac valve (202) into the delivery tool (401), preferably, placement data (203) relating to the placement of the delivery tool (401) with respect to the patient, in particular before insertion of the delivery tool (401) into the vessel of the patient. The computing unit (102) is adapted to determine orientation data (300) relating to the expected orientation of the prosthetic cardiac valve (2) with respect to the native cardiac valve (1), in particular to the position of the coronaries (RCA, LCA) and / or to the position commissures (4), in the final position of the prosthetic cardiac valve (1) on basis of the input data.

Description

[0001] SYSTEM, COMPUTER PROGRAM AND COMPUTER PROGRAM PRODUCT FOR PLANNING, PREPARING, MONITORING AND / OR EXECUTING OF A CLINICAL INTERVENTION FOR IMPLANTING A CARDIAC VALVE

[0002] The present invention relates to a system, a method, a computer program and a computer program product for planning, preparing, monitoring and / or executing of a clinical intervention for implanting a cardiac valve in a patient according to the independent claims .

[0003] Implanting a prosthetic cardiac valve may concern an aortic valve replacement, a mitral replacement, a tricuspid valve replacement or a pulmonary valve replacement by an artificial heart valve. Current aortic valve replacement approaches may include closed heart surgery. Trans-catheter aortic valve implantation (TAVI) or trans-catheter aortic valve replacement (TAVR) is a minimally invasive procedure for treating a failing aortic valve.

[0004] A valve implant (e.g. a bioprosthetic valve made of e.g. porcine or bovine pericardium sutured on a metal stent) typically is crimped inside a catheter. The catheter is inserted, for example, via the femoral artery and is pushed upstream along the aorta up to the diseased native valve, delivering the prosthetic cardiac valve to a final position, in which the valve implant is deployed. Main complications during implantation are vascular injury, stroke, cardiac injury, aortic regurgitation, cardiac conduction abnormalities and valve misplacement.

[0005] In particular, the orientation of the implanted prosthetic cardiac valve should comply with the orientation of the commissures of the native valve to provide an optimal access to the coronaries after the implantation. Due to a commissural misalignment, the coronary access may be limited, and consequently the coronary artery flow may be disturbed. There may arise a stress and a strain to the leaflets, and in the worst case a central leak. The effectiveness of an outer sealing skirt may be affected due to misalignment. The grade of commissural alignment or misalignment can be detected by a fluoroscopic image. In case of misalignment, it might be necessary to reposition or even to reimplant the valve.

[0006] Typically, the implantation process is image guided and makes use of patient images taken and annotated in the planning stage. Identifying how to perform the procedure optimally is time consuming, requires considerable skills of the operator and bears the risk of errors.

[0007] Co-pending EP 4 477 174 Al discloses a system and a method for automatic planning of a clinical intervention for implanting a cardiac valve in a patient, wherein a selected surgical tool and / or a selected surgical method are selected on basis of input data. The input data may comprise characteristics relevant for commissural alignment, which may relate to the intended or target orientation of an implant valve at the implant position and / or to an orientation of an implant valve within a delivery device or delivery tool, for example to the valve crimping position, which may be adjustable and / or which has to be taken into account.

[0008] Preparing of a clinical intervention for implanting a prosthetic cardiac valve implant may include loading a prosthetic valve into a delivery tool, in particular using a loading tool, such as a crimping device. It i s an obj ect of the present invention to overcome the drawbacks of the prior art . In particular , the system and the method according to the present invention shall provide proper commis sural alignment .

[0009] These and other obj ects are solved with systems , methods and a computer program according to the independent claims .

[0010] According to a first aspect of the invention , the system for monitoring a clinical intervention for implanting a prosthetic cardiac valve in a patient comprises an input interface for entering data , a computing unit , and an output interface , preferably a display device , for providing output data .

[0011] According to the f irst a spect , the computing unit is adapted to receive input data via the input interface .

[0012] The input data at least comprise patient data relating to characteristics of the patient , in particular characteri stic relating to the native anatomy at the target site , preferably image data of the native valve .

[0013] The input data further comprise valve data relating to the position and / or the orientation of the prosthetic cardiac valve with re spect to the patient , preferably image data of the pros thetic cardiac valve .

[0014] The valve data preferably relate to the position and / or the orientation of the prosthetic cardiac valve during delivery, preferably close to the final position .

[0015] The image data of the prosthetic valve may comprise a characteri stic feature of the prosthetic cardiac valve , for example a radiopaque element or an element with a di stinctive geometry, which indicates a rotational position of the prosthetic valve .

[0016] The input data may comprise deployment data , relating to characteristics of the relea se of the prosthetic cardiac valve from the delivery tool .

[0017] The computing unit may be adapted to receive target orientation data and / or may be adapted to determine target orientation data based on the patient data . The target orientation data may refer to an orientation of the native anatomy at the target site . The orientation of the target i s in particular a rotational position of the native heart valve around an axis of the heart valve . A characteristic feature of the valve prosthe sis should be aligned in the finally deployed state with re spect to this target orientation .

[0018] The computing unit is adapted to determine orientation data based on the input data . The orientation data relate to the expected orientation of the prosthetic cardiac valve in an at least partially deployed configuration with respect to the native valve .

[0019] The computing unit may use a trained Al model for determining the expected orientation of the prosthetic valve with respect to the native valve .

[0020] The computing unit is adapted to provide output data to the output interface which are based on the orientation data and preferably on the target orientation .

[0021] Preferably, the di splay device is adapted for di splaying an orientation indicator ba sed on the output data . The orientation indicator indicates the expected orientation of the prosthetic valve with respect to the native cardiac valve. Preferably the orientation indicator also indicates the target orientation, in particular the rotational position of the native valve with respect to the axis of the native valve.

[0022] According to a second aspect of the invention, the system for planning, preparing, monitoring and / or executing of a clinical intervention for implanting a prosthetic cardiac valve in a patient comprises an input interface for entering data and a computing unit. Preferably, it is a system as described above. The planning, preparing, monitoring and in particular executing can be carried out at least partially automatically.

[0023] The computing unit is adapted to receive input data via the input interface.

[0024] The input interface preferably is selected from the group of a keyboard, a vocal interface, a mechanical button or switch, a mouse, joystick, haptic glove, a graphical user interface, in particular a touchscreen, a motion detector, in particular a gaze tracker or a head motion detector, a virtual reality or an augmented reality interface, and a 3D monitor, in particular a hologram presentation combined with a haptic glove or a motion detection .

[0025] The input data comprise patient data relating to characteristics of the patient.

[0026] The patient data relating to characteristics of the patient may comprise imaging data, in particular 2D and / or 3D imaging data and / or 2D sliced imaging data. The 3D imaging data may include one or a combination of MRI (Magnetic resonance imaging) -data, CBCT (Cone-beam computed tomography) -data , multi-view ultrasound data, 3D ultrasound data and data of a surface scanning, for example using pressure sensors or a balloon.

[0027] The patient data relating to characteristics of the patient may relate to (i) the vessel shape, in particular of vessels on the path from the access point to the native valve, such as the femoral artery and the aorta, such as vessel length, width and tortuosity, and / or may relate to (ii) the vessel state, such as the presence of an aneurism and / or a thrombosis, the existence of calcifications and / or plaques.

[0028] The patient data relating to characteristics of the patient may relate to characteristics of the native valve to be functionally replaced, for example shape, such as diameter, and state of native valve, such as kind of malfunction or grade of calcification and orientation of the commissures and the shape of the left ventricular outflow tract.

[0029] The patient data relating to characteristics of the patient may comprise information about an insertion tool, in particular regarding type and size, and when already fixed to the patient and the axis of the insertion tool coincides with the axis of the vessel relating to the rotational orientation of the insertion tool with respect to the vessel axis.

[0030] The input data further comprise cardiac valve data relating to (i) the orientation of a prosthetic cardiac valve with respect to a delivery tool to be used for implantation and / or (ii) relating to the orientation of a prosthetic cardiac valve with respect to a loading tool for loading the prosthetic cardiac valve into the delivery tool and / or ( iii ) relating to the position , orientation and / or deployment state of the prosthetic cardiac valve with respect to the patient , preferably in the vicinity of the final position .

[0031] The deployment state characteri zes the degree of expans ion of the prosthetic valve .

[0032] In particular , the input data comprise image data of the prosthetic cardiac valve during delivery and / or deployment .

[0033] In the present application , the terms "orientation" and "rotation" relate to a rotational position around the valve axis . Typically, when arranged in the delivery tool or in the loading tool , the prosthetic valve is concentrically arranged in at least a part of the tool , such that the valve axis coincides with the axi s of the respective part of the tool . Even when the tool axis and the valve axis coincide ( also when the prosthetic valve i s not arranged within the tool ) the valve may have different orientations within respect to the re spective tool as there i s still a rotational degree of freedom . The orientation may be given by a rotational angle between a specific mark on the prosthetic valve and a specific mark on the tool .

[0034] Cardiac valve data relating to the orientation of a prosthetic cardiac valve with respect to a delivery tool to be used for implantation may include information about the orientation of the prosthetic cardiac valve with respect to a typical part of the delivery device , for example an introducer sheath and / or to a delivery balloon . Cardiac valve data may comprise information about characteristic features , such as markers on the prosthetic valve , in particular rotational markers .

[0035] Different manufacturers use various markers for facilitating commis sure alignment of the prosthetic valve .

[0036] These characteristic features may be part of or derived from image data provided by an imaging device or imaging system and / or the information about the characteristic feature s may be provided separately .

[0037] As long as the prosthetic cardiac valve is not fully expanded, and in particular during delivery, it may be pos sible to correct the orientation of the prosthetic valve . If an expected orientation of the fully deployed valve is not properly aligned with the native anatomy, the delivery tool may be rotated such as to adj ust the rotational pos ition of the prosthetic valve , typically after the delivery tool has been withdrawn to an area facilitating its rotation such as the descending aorta . Selfexpandable prosthetic cardiac valves may for example be retracted into the delivery tool , such that the orientation of the valve may be changed by rotating the delivery tool .

[0038] The cardiac valve data relating to the pos ition and / or orientation of the prosthetic valve with respect to the patient may be provided by an imaging system and / or a vis ion tracking system supported by an Al model . The image data can be pre-proces sed by an imaging system or a vision tracking system or they can be fully proces sed by the present system . The imaging system or the vis ion tracking system can also be part of the present sys tem . The imaging system and / or the vision tracking system may be based on fluoroscopy .

[0039] The computing unit may be adapted to receive information on and / or to determine a reference coordinate system .

[0040] The reference coordinate system may relate to the patient , the delivery tool , an operating table and / or an X-ray device . The reference coordinate system may be related to the orientation and pos ition of the native valve .

[0041] The input data may further comprise deployment data relating to characteristics of the release of the prosthetic cardiac valve from the delivery tool . Depending on the characteristics of the deployment tool and / or the prosthetic cardiac valve , the prosthetic cardiac valve may e . g . rotate around a certain angle when released or after being released from the delivery tool .

[0042] Prosthetic cardiac valve s deployed by an inf latable balloon may remain oriented more stably than self-deploying prosthetic cardiac valves .

[0043] Deployment data relating to characteri stics of the release may provide a rotation angle of a specific prosthetic valve after release . Deployment data relating to characteristics of the release preferably are based on a statistical model such as a trained Al model .

[0044] A rotation angle after release may be taken into account for predicting the expected orientation of the prosthetic valve in the finally deployed pos ition . Input data may comprise delivery tool data relating to the characteristics of the delivery tool and / or relating to the position and / or orientation of the delivery tool with respect to the patient .

[0045] It may not be nece s sary to provide such delivery tool characteri stics data , for example , when a torsion free delivery tool is used . For a torsion f ree delivery tool , a relative orientation between distal end and proximal end remains constant .

[0046] Delivery tool data may be provided by a measurement of the delivery tool position and / or orientation , in particular the position and / or orientation of the distal end hous ing the prosthetic valve during movement towards the native valve .

[0047] Delivery tool data relating to the pos ition and / or orientation of the distal end of the delivery tool with respect to the patient may be provided by image data , preferably by the same image data as for the cardiac valve data relating to the position and / or orientation of the prosthetic cardiac valve with respect to the patient , for example comprising markers on the prosthetic cardiac valve .

[0048] The input data may further comprise placement data relating to the placement of the loading tool with respect to the delivery tool , in particular before loading the prosthetic cardiac valve into the delivery tool .

[0049] The orientation of the loading tool with respect to the delivery tool may be predetermined in order to provide an unambiguous connection between the loading tool and the delivery tool .

[0050] Alternatively, there may a rotational degree of freedom, when functionally connecting the loading tool and the delivery tool . A combination of placement data relating to the placement of the loading tool with re spect to the delivery tool and the orientation of a prosthetic cardiac valve with respect to the loading tool may result in the orientation of a prosthetic cardiac valve with re spect to a delivery tool .

[0051] The input data may further comprise placement data relating to the placement of the delivery tool with re spect to the patient , in particular before insertion of the delivery tool into the ves sel of the patient . The orientation of the delivery tool with re spect to an insertion tool , which may be fixed to the patient , may be predetermined in order to provide an unambiguous acces s of the delivery tool into the insertion tool . Alternatively, there may a rotational degree of f reedom, when inserting the delivery tool into the insertion tool .

[0052] Placement data relating to the placement of the delivery tool with re spect to the patient may include orientation data relating to the rotational orientation of the delivery tool with respect to a ves sel axis when the axis of the valve holding part of the delivery tool coincides with the axis of the ves sel , relating to the rotational orientation of the delivery tool with respect to an the axis of an insertion tool when the axis of the valve holding part coincide s with the axis of the insertion tool .

[0053] Placement data may also include an angle between the axis of the valve holding part and the axis of the ves sel and / or position data of the delivery tool with re spect to a reference sys tem such as the room .

[0054] Said computing unit is further adapted to determine orientation data relating to the expected orientation of the prosthetic cardiac valve with respect to the native cardiac valve . The orientation with respect to the native cardiac valve may be the orientation with respect to any native valve feature , but also an orientation with respect to feature s of the environment of the native valve . In particular , the expected orientation may be an orientation with respect to the position of at least one the coronaries and / or to the position of at least on commis sure of the native valve , in the final position of the prosthetic cardiac valve on basis of the input data .

[0055] Orientation data relating to the expected orientation of the prosthetic cardiac valve may for example be given by an angle between the commis sures of the native valve and the commis sure s of the prosthetic valve .

[0056] On the basis of an initial orientation of the valve , in particular before insertion into the patient , and / or based on an intermediate orientation of the prosthetic cardiac valve during delivery and / or during deployment , and preferably on the basis of the characteristics of the used tools , in particular delivery tool data , and / or on the ba sis of the characteri stics of the patient , the system may determine the expected f inal orientation of the prosthetic valve .

[0057] Based on the position and / or the orientation of the prosthetic cardiac valve during delivery, in particular during advancement and / or close to an intended deployment pos ition , and ba sed on the characteristics of the patient , the system may determine and predict the expected final orientation of the prosthetic valve . The computing unit may be adapted to determine the expected final orientation of the prosthetic valve relative to the native valve , in particular its rotational position .

[0058] For example , the computing unit may be adapted to determine the rotational position of a characteristic feature of the prosthetic cardiac valve relative to a characteristic feature of the native valve .

[0059] The characteristic feature of the native valve may be part of the input data and / or the computing unit may be adapted to determine the characteristic feature on the ba sis of the input data , for example based on image data of the native heart valve .

[0060] The system may comprise a trained Al model for predicting rotational positions of the prosthetic valve after deployment , which model may be specifically trained for a specif ic type of prosthetic cardiac valve or for any prosthetic cardiac valve .

[0061] Thus , before final deployment , a user can anticipate the final position and orientation of the prosthetic valve .

[0062] This determination of orientation data allows to improve the delivery proces s of the prosthetic valve and / or the preparation of the delivery in order to achieve an optimized orientation of the deployed prosthetic valve .

[0063] The computing unit may be adapted to determine orientation data on basi s of input data , received before and / or during the delivery procedure . Thus , the computing unit may be adapted to determine and / or to update orientation data also during the delivery proce s s . The computing unit may be adapted to determine orientation data on the basis of input data as explained above and / or on the basis of data stored in the system, for example delivery tool characteristics data and / or pre-operational data .

[0064] The computing unit may be adapted to determine a target orientation or an optimal orientation of the prosthetic cardiac valve and / or an acceptable target range , for example with reference to reference coordinates .

[0065] The target orientation and / or the target range may be related to at least one characteristic feature of the native valve , such as the rotational position of the commi s sures and / or the coronaries .

[0066] The computing unit may be adapted to compare the expected orientation of the prosthetic cardiac valve with a target orientation and / or an acceptable orientation range .

[0067] The computing unit may be adapted to determine a dif ference between the target orientation ( e . g . the rotational position of the native valve ) and an expected orientation of the prosthetic cardiac valve , e . g . in terms of an angle .

[0068] The computing unit may be adapted to determine a dif ference between a target range ( e . g . an angular range around the rotational position of the native valve ) and an expected orientation of the prosthetic cardiac valve , e . g . in terms of an angle .

[0069] The input data may comprise data relating to the type and / or size of the prosthetic cardiac valve . The input data may also comprise data relating to local hemodynamics such as pres sure and / or flow gradient .

[0070] Data relating to the type of the cardiac valve may relate to the shape of the valve to be implanted and the target position and / or the intended target orientation of the valve to be implanted with respect to the native valve to be functionally replaced, in particular the intended implantation depth , the tilt and the orientation of the valve to be implanted .

[0071] In particular , data relating to the type of the prosthetic cardiac valve may comprise information about a specific or characteri stic feature which can be used as a reference mark for characterizing the rotational orientation of the prosthetic valve with respect to the delivery tool , the loading tool , a ves sel of the patient and / or the native valve .

[0072] The computing unit may be adapted to provide output data .

[0073] The output data may comprise output data for displaying orientation data on an output device and / or a display device .

[0074] The output data may comprise the target orientation and / or a target range , in particular with respect to a reference coordinate system .

[0075] The output data may comprise a difference value between the target orientation and the expected orientation of the prosthetic cardiac valve . The output data may comprise data for displaying an orientation indicator relating to the difference between the target orientation and the expected orientation of the prosthetic cardiac valve .

[0076] The output data may comprise output data related to an optimized orientation of the prosthetic cardiac valve with respect to the delivery tool , in particular for providing signals and / or instructions to rotate the prosthetic cardiac valve within the delivery tool and / or for providing signal s and / or instructions for loading the prosthetic cardiac valve into the delivery tool .

[0077] An optimized orientation of the prosthetic cardiac valve with respect to the delivery tool re sults in an expected orientation of the prosthetic cardiac valve with respect to the native cardiac valve wherein the prosthetic valve is at least not completely misaligned .

[0078] Signals and / or instructions may provide for directly and automatically controlling a respective tool .

[0079] Signals and / or instructions may inform a user to control a respective tool .

[0080] The output data may comprise data related to monitoring , in particular related to an axial and / or rotational motion of the delivery tool and / or the prosthetic cardiac valve during delivery and / or during deployment and / or data related to the position and / or the orientation of the prosthetic cardiac valve af ter deployment . The output data may comprise data related to an optimized position of the delivery tool with respect to the patient before insertion of the delivery tool into the ve ssel of the patient , in particular for providing signals and / or instructions to change the position of the delivery tool with re spect to patient , preferably for providing signal s and / or instructions to change the position of the delivery tool with re spect to an insertion device , and / or for providing s ignals and / or instructions to change the position of the insertion device with respect to the patient .

[0081] Data related to an optimized position of the delivery tool with respect to the patient may include information about the angle s for insertion the delivery device into the ves sel and to orientate the cardiac valve in a proper way, that is to choose the proper angle between ves sel axi s and valve axis , and to choose a rotation angle of the valve with respect to ve s sel and / or valve axis .

[0082] The output data may comprise output data related to an optimized navigation of the delivery tool to the final position of the cardiac valve , in particular for providing navigation data in terms of movement instructions . Movement instructions may include requests to rotate the delivery tool in certain direction when achieving at a certain position .

[0083] The computing unit may be adapted to determine a rotational parameter of the finally deployed prosthetic valve . The rotational parameter may be related to the dif ference between a target orientation and / or an optimal orientation and / or a target range and the rotational position of the fully deployed prosthetic cardiac valve . The rotational parameter may e . g . be stored in a patient file for post treatment analyses . The output data may comprise data related to a ris k value based on the orientation data . The output data in particular may comprise output data for di splaying the ris k value , preferably continuously and / or in real time .

[0084] The ris k value may be related to the orientation data and as the orientation data may be updated during the delivery proces s , also the ris k value may be updated .

[0085] The computing unit may be adapted to provide output data for carrying out a procedure selected from loading the prosthetic valve or a valve component into the delivery tool , moving and in particular rotating the prosthetic valve with respect to a loading tool , moving and in particular rotating the prosthetic cardiac valve within the delivery tool , positioning the delivery tool with respect to the patient , navigating the delivery tool to the vicinity of the final position , withdrawing the delivery tool from the vicinity of the f inal position, rotating the delivery tool , preferably in the descending aorta .

[0086] Output data concerning the loading the prosthetic valve into the delivery tool may comprise data being related to the orientation of the prosthetic valve with re spect to the delivery tool and / or to the orientation of a loading tool with respect to the delivery tool .

[0087] Output data concerning the rotating the prosthetic valve with respect to a loading tool may be related to a rotation of the valve before , during and / or after being crimping . Output data concerning the positioning of the delivery tool with re spect to the patient may relate to the positioning of the delivery tool with respect to an insertion tool .

[0088] Output data concerning the navigation of the delivery tool to the vicinity of the final position may relate to recommendations with re spect to a movement direction and / or velocity .

[0089] Output data concerning withdrawing the delivery tool may comprise instructions to withdraw the delivery tool , in particular for moving the distal end of the delivery tool with the prosthetic cardiac valve , to the de scending aorta . There , the distal end of the delivery tool ( and hence the prosthetic cardiac valve housed therein ) may be rotated .

[0090] Output data concerning the rotation of the delivery tool may comprise instructions to rotate the delivery tool around a certain angle , preferably in the descending aorta .

[0091] For example , when the computing unit has determined that the expected orientation of the prosthetic cardiac valve is outside a predetermined acceptable range , the computing unit may provide output data , instructing a user to bring the delivery device into an appropriate position , for example in the descending aorta , where the delivery device and thus the prosthetic cardiac valve can be more easily rotated .

[0092] Alternatively, the computing unit may provide output data , inviting a user to rotate the prosthetic cardiac valve , if pos sible . Alternatively, the computing unit may provide output data to control a delivery robot for the axial movement and / or rotation of the delivery tool and / or the prosthetic cardiac valve .

[0093] The cardiac valve data may comprise a rotational pos ition of a characteristic feature of the prosthetic cardiac valve during delivery, for example with respect to a reference coordinate system .

[0094] The rotational pos ition may comprise an angle within the reference coordinate system, for example linked to the va sculature of the patient near the native valve or linked to the orientation of the native valve .

[0095] Alternatively, the computing unit may be adapted to determine the orientation of a characteri stic feature of the prosthetic cardiac valve during delivery based on delivery tool data , in particular image data of the di stal end comprising the prosthetic cardiac valve of the delivery tool during delivery .

[0096] Based on the rotational position of the characteristic feature during delivery and based on the patient data , the computing unit may determine the expected orientation of the characteris tic feature and thus the expected orientation of the prosthetic cardiac valve in the finally deployed position .

[0097] The cardiac valve data may comprise an annular position or orientation of a characteri stic feature of the prosthetic cardiac valve placed in a delivery device with respect to the delivery device .

[0098] The cardiac valve data may comprise an annular position or orientation of a characteri stic feature of the prosthetic cardiac valve with respect to a loading tool for loading the prosthetic cardiac valve to the delivery device , in particular a crimping device .

[0099] The characteristic feature of the prosthetic cardiac valve may be a suture hole , a commis sural post , a fixation element and / or a marker , for example attached to a metal support . The characteri stic feature usually is a feature , that may be detectable in image data provided by an imaging device or by imaging system comprising a computer vision system combined with Al .

[0100] The computing unit may be adapted to create a virtual model representing a body part involved in the procedure and the prosthetic valve to represent the orientation data . The computing unit may be adapted to simulate the navigation of the prosthetic valve through the delivery path and / or to determine suitable pos itions for rotation and / or rotation angles of the delivery tool during delivery .

[0101] The computing unit may be adapted for providing output data to an output interface , in particular the system may comprise an output interface .

[0102] The output interface may compri se an output device for representing output data , such as a monitor , in particular a 3D monitor , a display, a virtual reality or an augmented reality interface , a warning indicator and / or a visual pointer or an acoustic output such as a synthetic voice generator . The synthetic voice may be generated in any desired language .

[0103] The visual pointer may be a laser pointer , preferably to be arranged in a predetermined relationship with respect to the patient or to a representation of the patient . The laser pointer may highlight a path and / or a specific position, for example on a 2D or 3D representation of a virtual model of a body part.

[0104] The output interface may be connected or connectable to the delivery tool, to an insertion tool, to a loading tool, such as a crimping device, and / or to a robot and / or to a display. The output interface may provide control commands to the delivery tool, the insertion tool and / or the loading tool and / or may provide output data to an output device of the delivery tool, the insertion tool and / or the loading tool.

[0105] An assembly may comprise a system as described above and a at least one of a delivery tool, an insertion tool, a loading tool, an output device, a display device, an imaging device and a prosthetic valve or valve component.

[0106] The delivery tool and / or the loading tool may comprise means for rotating the prosthetic cardiac valve, for example elements, which allow active rotation and / or passive rotation and / or self-orientation of the prosthetic valve around the valve axis.

[0107] A rotation controller may be integrated in the delivery system, which allows for simple and straightforward alignment.

[0108] An imaging device, such as an X-ray device, an MRT (magnetic resonance tomography) device, an MDCT (multi detector computed tomography) device and / or a fluoroscopy device, may provide data for representing at least a part of the patient' s body.

[0109] The display device may be adapted for displaying an orientation indicator, preferably a real-time orientation indicator. The orientation indicator may show the expected orientation of the partially or fully expanded prosthetic heart valve a s compared to the target orientation or the optimal orientation of the prosthetic heart valve .

[0110] The expected orientation is determined based on input data , in particular compris ing a position and / or orientation of the prosthetic cardiac valve relative to the patient during delivery .

[0111] According to further aspect of the invention , a method for computer-based monitoring of a clinical intervention for implanting a prosthetic cardiac valve in a patient is provided . The method preferably uses a system according to the first aspect of the invention a s described above .

[0112] The method comprises the steps of

[0113] - receiving input data relating to characteri stics of the patient via an input interface , preferably image data of the native valve ,

[0114] - receiving input data , preferably image data , relating to the pos ition and / or orientation of the prosthetic cardiac valve with respect to the patient , preferably in the vicinity of the final pos ition ,

[0115] - preferably, receiving input data relating to characteristics of the release of the prosthetic cardiac valve from the delivery tool ,

[0116] - determining orientation data relating to the expected orientation of the prosthetic cardiac valve in a partially or fully deployed pos ition with respect to the native valve , in particular with re spect to a feature of a valve environment , for example a position of at lea st one coronary and / or a pos ition of at least one commis sure , - preferably di splaying an orientation indicator , which indicates the expected orientation of the prosthetic cardiac valve with re spect to the native valve .

[0117] An imaging device and / or an imaging system comprising computer vision algorithms combined with Al , may provide image data of the region of the native valve .

[0118] An orientation of a target point or a target range of the native valve , which corresponds to an optimal angular pos ition of a characteri stic feature of the finally deployed prosthetic cardiac valve , may be received or may be determined .

[0119] An imaging device and / or an imaging system comprising computer vision algorithms combined with Al , may provide image data of the prosthetic valve placed in the delivery device , preferably of a characteristic feature of the prosthetic valve in the vicinity of the native valve before final deployment .

[0120] The delivery tool and the contained prosthetic cardiac valve may be tracked during delivery and the rotational position of a characteristic feature , such a marker feature , of the prosthetic cardiac valve may be determined with respect to coordinate s in a reference coordinate system .

[0121] On the basis of the patient data and delivery tool characteris tics , the rotational pos ition of the characteristic feature during delivery may be determined and an expected orientation of the characteristic feature at the partially or finally deployed position may be predicted .

[0122] If the expected orientation of the characteristic feature is not in a predetermined target range , the user or a robot may be instructed to rotate the delivery tool in order to rotate the prosthetic cardiac valve . The user or a robot may be f irst instructed to reposition and in particular to withdraw the delivery tool , such that the distal end is positioned in the descending aorta and subsequently to rotate the delivery tool and thus the prosthetic cardiac valve .

[0123] The expected orientation of the characteri stic feature at the final position may then be determined again and may be compared with the target position or a target region .

[0124] An output device may display an orientation indicator , which may show the expected orientation of the prosthetic cardiac valve a s compared to the native valve , for example the expected orientation as compared to the target point or the target range .

[0125] According to a further a spect of the invention , a method for computer-based planning , preparing , monitoring and / or executing of a clinical intervention for implanting a cardiac valve in a patient is provided . The method may be a method as described above and may use a system as described above .

[0126] According to the method, input data relating to characteristics of the patient are received via an input interface .

[0127] Input data are received relating to the orientation of a cardiac valve to be implanted with respect to a delivery tool to be used for implantation and / or with respect to a loading tool for loading the prosthetic cardiac valve into the delivery tool . Preferably, input data relating to the placement of the delivery tool with respect to the patient are received, in particular before insertion of the delivery tool into the ves sel of the patient .

[0128] Input data are received via an input interface . Input data correspond to input data as described above .

[0129] The method comprises the step of determining orientation data relating to the orientation of the cardiac valve with respect to the native valve and / or a feature of a valve environment , in particular to the position of at least one coronary and / or to the pos ition of at least one commis sure , in the final position .

[0130] Orientation data correspond to orientation data as described above .

[0131] The method may comprise the further step of receiving data relating to the type and / or size of the cardiac valve or to local hemodynamics such as pre s sure and / or f low gradient . Data relating to the type and / or s ize of the cardiac valve correspond to cardiac valve data as de scribed above .

[0132] The method may comprise the further step of providing output data as described above .

[0133] The output data may be selected from output data for di splaying orientation data on an output device , output data related to an optimized orientation of the prosthetic cardiac valve with respect to the delivery tool , in particular providing signals and / or instructions to move and in particular to rotate the prosthetic cardiac valve within delivery tool and / or for providing signals and / or instructions for loading into the delivery tool , output data related to an optimized pos ition of the delivery tool with respect to the patient before insertion of the delivery tool into the ves sel of the patient , in particular for providing signals and / or instructions to change the position of the delivery tool with respect to patient , preferably providing signals and / or instructions to change the position of the delivery tool with respect to an insertion device , output data related to an optimized navigation of the delivery tool to the final position of the cardiac valve , in particular providing navigation data in terms of movement instructions and output data related a to ris k value ba sed on the orientation data .

[0134] The method may comprise the further step of carrying out a procedure selected from loading the prosthetic valve or a valve component into the delivery tool , moving and in particular rotating the prosthetic valve with respect to the loading tool , moving and in particular rotating the prosthetic cardiac valve with re spect to the delivery tool , in particular within the delivery tool .

[0135] The method may comprise the further step of carrying out a procedure selected from pos itioning the delivery tool with respect to the patient , in particular positioning the delivery tool with re spect to an insertion tool and navigating the delivery tool to the final position .

[0136] Additionally, or alternatively, the method may comprise the step of withdrawing the delivery tool from the vicinity of the final position and rotating the delivery tool , preferably in the des cending aorta . Additionally, or alternatively, the method may comprise the steps of interrupting or stopping the valve delivery and / or retrieving the valve or a valve component . Thi s may be beneficial in particular if during the procedure , problems or ris ks become apparent .

[0137] The method may comprise the step of receiving cardiac valve data , wherein the cardiac valve data i s selected from an orientation of a characteristic feature of the prosthetic cardiac during delivery, for example with respect to a reference coordinate system, an annular position or orientation of a characteri stic feature of the prosthetic cardiac valve placed in a delivery device with respect to the delivery device , and an annular position or orientation of a characteristic feature of the prosthetic cardiac valve with respect to a loading device for loading the prosthetic cardiac valve to the delivery device , in particular a crimping device .

[0138] The method may comprise the further step of creating a virtual model representing a body part involved in the procedure and the prosthetic valve to represent the orientation data .

[0139] A computer program according to the invention compri ses a program code for carrying out the steps of the method a s described above when the program i s executed on a computer , in particular on a computer of a system as de scribed above and / or an as sembly as described above .

[0140] A computer program product according to the invention can be loaded directly into an internal memory of a digital computer and comprise s software code portions executing the method as described above when the program is running on the digital computer of a system as des cribed above and / or an a s sembly as described above . The invention is explained in the following by means of exemplary embodiments and the accompanying drawing , in which :

[0141] Fig . 1 is a schematic pre sentation of a system according to the invention ;

[0142] Fig . 2 shows a view to the annular plane of an aortic root having ( i ) a native valve and ( ii ) having an implanted valve ;

[0143] Fig . 3 shows a first example of an orientation indicator;

[0144] Fig . 4 shows a first example of an orientation indicator .

[0145] Fig . 1 is a schematic presentation of a system 100 according to the invention .

[0146] The system 100 is for automatic planning and / or preparing of a clinical intervention for implanting a prosthetic cardiac valve in a patient .

[0147] The system 100 comprises an input interface 101 for entering data , a computing unit 102 and an output interface 103 .

[0148] The computing unit 102 i s adapted to receive input data 201 , 202 , 203 via the input interface 101 .

[0149] The input data 201 , 202 , 203 comprise patient data 201 relating to characteristics of the patient , cardiac valve data 202 relating to the orientation of a prosthetic cardiac valve with respect to a delivery tool to be used for implantation and / or with re spect to a loading tool for loading the prosthetic cardiac valve into the delivery tool and placement data 203 relating to the placement of the delivery tool with respect to the patient . The computing unit 102 i s adapted to determine orientation data

[0150] 300 relating to the expected orientation of the prosthetic cardiac valve with re spect to the native cardiac valve , in particular to the coronaries position and / or to the commis sural position , in the final position of the prosthetic cardiac valve on basi s of the input data .

[0151] The computing unit 102 i s adapted to provide output data 301 on basi s of the orientation data 300 relating to the expected orientation of the prosthetic cardiac valve to the output device 103 .

[0152] The output data 301 is selected from output data 301 for displaying orientation data 300 on an output device 104 , output data 301 related to an optimized orientation of the prosthetic cardiac valve with respect to the delivery tool , output data

[0153] 301 related to an optimi zed pos ition of the delivery tool with respect to the patient before insertion of the delivery tool into the ves sel of the patient , output data 301 related to an optimized navigation of the delivery tool 401 to the final position of the cardiac valve and output data 301 related to a ris k value based on the orientation data .

[0154] The output data 301 may be displayed on the output device 104 .

[0155] The output device displays an orientation indicator 105 .

[0156] The output device 103 may use output data 301 for controlling a delivery tool 401 and / or a loading tool 402 .

[0157] Fig . 2 shows the annular plane of an aortic root heart having ( i ) a native valve 1 and ( ii ) having an implanted prosthetic cardiac valve 2 . The commissures 3 of the implanted prosthetic cardiac valve 2 may have an orientation that deviates by an angle a from the orientation of the commissures 4 of the native valve 1.

[0158] As long as the deviation angle a is between 0° and 15°, "commissural alignment" is assumed. The path to the right coronary artery RCA and to the left coronary artery LCA remains undisturbed .

[0159] A "mild" commissural misalignment is assumed for an angle range between 15° and 30°, a "moderate" commissural misalignment is assumed for an angle range between 30° and 45° and a "severe" commissural misalignment is assumed for an angle range between 45° and 60°.

[0160] Due to commissural misalignment the coronary access may be limited, and consequently the coronary artery flow may be disturbed. There may arise a stress and a strain to the leaflets, and in the worst case a central leak. The effectiveness of the outer sealing skirt may be affected due to misalignment, and it might be necessary to reimplant the valve.

[0161] In a view, which brings neighbouring cusps to overlap (see dashed arrow) , one of the TAVI-valve commissural posts should be lateralized at the right side of the fluoroscopic image. Alternatively, a view which brings the right and the left coronary ostia to overlap may be used.

[0162] Orientation data 300 relating to the expected orientation of the prosthetic cardiac valve 2 given by the deviation angle a and defining a grade of commissural alignment or misalignment can be determined by the system 100 on bas is of input data relating to the patient , to the delivery tool 401 and to the prosthetic cardiac valve 2 .

[0163] For automatically determining the grade of commi s sural alignment of an implant valve , a 3D geometrical model of the , preferably patient specific , aortic anatomy from femoral acces s to the annular ring , in particular a rigid model , a valve crimping position and a delivery device orientation before implantation can be used as input data .

[0164] Optionally, a 3D biomechanical model of the patient artery can be taken into account as further input data , which for example provide s the individual eccentricity of the coronaries RCA, LCA with re spect to the native valve 1 and which may be provided by a fluoroscopy imaging method .

[0165] A model simulating the interaction of the delivery device with the static 3 D anatomy or / and a model s imulating the interaction of the delivery device with the dynamic 3D anatomy can be provided by the computing unit ( see figure 1 ) .

[0166] A reduced model of the delivery device can be used a s input data .

[0167] On basi s of the calculated orientation data for example given by the grade of the commis sural alignment an optimal valve crimping pos ition and an optimal delivery device orientation before implantation may be provided as output data .

[0168] According to the intended final position and orientation , the computing unit may provide an output on how to crimp the valve on the delivery device and at which angle the delivery device should be inserted into the artery and into the native valve . Figure 3 shows a f irst example of an orientation indicator 105 .

[0169] An output device may be adapted for di splaying the orientation indicator 105 , preferably a real-time orientation indicator .

[0170] The orientation indicator 105 shows the predicted orientation of the deployed prosthetic heart valve as an arrow 106 , as compared to a target orientation 107 of the prosthetic cardiac valve , in this example the 12 o ' clock position .

[0171] Around the target orientation 107 of the prosthetic cardiac valve , the orientation indicator 105 shows a target range 108 .

[0172] As long as the arrow 106 is within the target range 108 , the prosthetic cardiac valve is expected to as sume an appropriate orientation after full deployment .

[0173] If the arrow 106 i s outs ide the target range 108 , the delivery tool may be retracted into the descending aorta . The delivery tool und thus the prosthetic cardiac valve can then be rotated and be placed again at a proper position for deployment .

[0174] New input data concerning the amended orientation of the prosthetic cardiac valve are received by the computing unit , updated orientation data are determined and updated output data 301 ( see figure 1 ) for displaying the orientation data are provided .

[0175] The arrow 106 of the orientation indicator 105 point s to a respective updated, new predicted position . Additionally, the orientation indicator 105 may show a further arrow 106 ' , representing the previous expected orientation before the prosthetic cardiac valve has been rotated .

[0176] Alternatively, the orientation indicator 105 may show an arrow , which represents the orientation of a marker feature of the prosthetic cardiac valve with respect to coordinates in a reference coordinate system, for example connected to the delivery tool , or to a proj ection of the aorta .

[0177] Preferably, the expected orientation i s determined and indicated a s long as the prosthetic cardiac valve is not fully deployed and released from the delivery tool . For self -expanding prosthetic cardiac valve s , the expected orientation still may be determined and indicated when the prosthetic cardiac valve is already partially expanded . If the expected deployed orientation is not appropriate , the prosthetic cardiac valve may be retracted into the delivery tool and may be rotated for re-ad- j ustment .

[0178] Additionally, the final orientation may be determined and / or indicated when the prosthetic cardiac valve is already fully deployed in the final position . If the final orientation is outs ide the target range , it may be neces sary to reposition the prosthetic cardiac valve or to remove the prosthetic cardiac valve and to provide a new prosthetic cardiac valve .

[0179] The orientation indicator 105 may comprise an outer ring region 109 , which may take a colour providing an indication of a quality of the rotational alignment . Alternatively, the arrow 106 may be shown in a particular colour . If the predicted orientation is outside of the target range or if a readj ustment of the prosthetic cardiac valve re sults in a worsened orientation , the colour may e . g . be red .

[0180] If predicted orientation might need further improvement or if a readj ustment of the prosthetic cardiac valve results in an improved orientation , but still needs further improvement , the colour may be orange .

[0181] If the orientation is within the target range , the colour may be green .

[0182] Figure 4 shows a second example of an orientation indicator .

[0183] The orientation indicator 105 shows the expected orientation of the prosthetic heart valve as a lateral position of an arrow 106 in a bar display . The target orientation 107 of the prosthetic cardiac valve is shown in the centre .

[0184] Around the target orientation 107 of the prosthetic cardiac valve , the orientation indicator 105 shows a target range 108 .

[0185] The arrow 106 shows , in which direction the prosthetic cardiac valve has to be rotated to achieve an optimal expected orientation .

[0186] Additionally, the orientation indicator 105 may show a further arrow 106 ' , representing the expected orientation of a previous valve position and / or orientation .

[0187] The arrow 106 may be shown in a specif ic colour ( for example a s explained above ) to indicate quality .

Claims

Claims1. A system for monitoring a clinical intervention for implanting a prosthetic cardiac valve (2) in a patient, the system (100) comprising- an input interface (101) for entering data,- a computing unit (102) , and- an output interface, preferably a display device for providing output data, wherein said computing unit (102) is adapted- to receive input data via the input interface (101) , the input data comprising o patient data (201) relating to characteristics of the patient, preferably image data of the native valve, o valve data (202) relating to the position and / or the orientation of the prosthetic cardiac valve with respect to the patient, preferably in the vicinity of the final position, preferably image data of the prosthetic cardiac valve during delivery and before final deployment,- to determine orientation data (300) based on the input data, said orientation data (300) relating to the expected orientation of the prosthetic cardiac valve (2) in an at least partially deployed configuration with respect to the native cardiac valve,- and to provide output data to the output interface based on the orientation data and preferably based on a target orientation , and wherein preferably, the display device is adapted for displaying an orientation indicator (105) , which indicates the expected orientation of the prosthetic cardiac valve (2) with respect to the native valve.A system for planning, preparing, monitoring and / or executing of a clinical intervention for implanting a prosthetic cardiac valve (2) in a patient, the system (100) comprising- an input interface (101) for entering data,- a computing unit (102) , wherein said computing unit (102) is adapted- to receive input data (201, 202, 203) via the input interface (101) , the input data comprising o patient data (201) relating to characteristics of the patient , o cardiac valve data (202) relating to the orientation of a prosthetic cardiac valve (202) with respect to a delivery tool (401) to be used for implantation and / or relating to the orientation of a prosthetic cardiac valve (202) with respect to a loading tool (402) for loading the prosthetic cardiac valve (202) into the delivery tool (401) and / or relating to the position and / or the orientation of the prosthetic cardiac valve (2) with respect to the patient, preferably in the vicinity of the final position , o preferably, delivery tool data, relating to the characteristics of the delivery tool and / or relating to the position and / or orientation with respect to the patient , o preferably, deployment data, relating to characteristics of the release of the prosthetic cardiac valve (202) from the delivery tool, o preferably, placement data (203) relating to the placement of the delivery tool (401) with respect tothe patient, in particular before insertion of the delivery tool (401) into the vessel of the patient, - to determine orientation data (300) relating to the expected orientation of the prosthetic cardiac valve (2) with respect to the native cardiac valve or a feature of a valve environment (1) , in particular to the position of the coronaries (RCA, LCA) and / or to the position commissures (4) , in the final position of the prosthetic cardiac valve (1) on basis of the input data (201, 202, 203) .

3. A system according to claim 1 or 2, wherein the input data comprise data relating to at least one of (i) the type of the prosthetic cardiac valve (2) , (ii) the size of the prosthetic cardiac valve (2) (iii) local hemodynamics such as pressure and / or flow gradient.

4. A system according to claim 1, 2 or 3, wherein the computing unit is adapted to provide output data (301) , wherein the output data (301) is selected from- output data (301) for displaying orientation data (300) on an output device (104) ,- output data (301) related to an optimized orientation of the prosthetic cardiac valve (2) with respect to the delivery tool (401) , in particular for providing signals and / or instructions to rotate the prosthetic cardiac valve (2) within the delivery tool (401) and / or for providing signals and / or instructions for loading into the delivery tool (401) ,- output data (301) related to an optimized position of the delivery tool (401) with respect to the patient before insertion of the delivery tool (401) into the vessel of the patient, in particular for providing signalsand / or instructions to change the position of the delivery tool (401) with respect to patient, preferably for providing signals and / or instructions to change the position of the delivery tool (401) with respect to an insertion device,- output data (301) related to an optimized navigation of the delivery tool (401) to the final position of the prosthetic cardiac valve (2) , in particular for providing navigation data in terms of movement instructions and- output data (301) related to a risk value based on the orientation data.

5. A system according to one of the preceding claims, wherein the computing unit is adapted to provide output data (301) for carrying out a procedure selected from- loading the prosthetic cardiac valve (2) or a valve component into the delivery tool,- moving, in particular rotating, the prosthetic cardiac valve (2) with respect to a loading tool;- moving, in particular rotating, the prosthetic cardiac valve (2) within the delivery tool,- positioning the delivery tool (401) with respect to the patient ,- navigating the delivery tool (401) to the vicinity of the final position,- withdrawing the delivery tool from the vicinity of the final position,- rotating the delivery tool and the prosthetic cardiac valve, preferably in the descending aorta.

6. A system according to any of the preceding claims, wherein the prosthetic cardiac valve (2) data comprise at least one of- a rotational position of a characteristic feature of the prosthetic cardiac valve (2) before final deployment,- an annular position of a characteristic feature of the prosthetic cardiac valve (2) placed in a delivery device with respect to the delivery device, and- an annular position of characteristic feature of the prosthetic cardiac valve (2) with respect to a loading tool (402) for loading the prosthetic cardiac valve to the delivery device, in particular a crimping device.

7. A system according to any of the preceding claims, wherein the computing unit (102) is adapted to create a virtual model representing a body part involved in the procedure and the prosthetic cardiac valve (2) to represent the orientation data.

8. A system according to any of the preceding claims, wherein the computing unit (102) is adapted for providing output data (301) to an output interface (103) , in particular the system comprising an output interface (103) .

9. A system according to claim 8, wherein the output interface (103) comprises an output device (104) for representing output data (301) , such as- a monitor, in particular a 3D monitor,- a display,- a virtual reality or an augmented reality interface ,- a warning indicator,a visual pointer an acoustic output such as a synthetic voice generator .

10. A system according to claim 8 or 9, wherein the output interface (103) is connected or connectable to the delivery tool, to an insertion tool and / or to a loading tool.

11. An assembly comprising a system according to any of the preceding claims, and further comprising at least one of- a delivery tool,- an insertion tool,- a loading tool,- an output device,- a display device,- an imaging device,- a prosthetic valve or valve component.

12. A method for computer-based monitoring a clinical intervention for implanting a prosthetic cardiac valve (2) in a patient, preferably using a system according to one of claims 1 to 10, the method comprising the steps of receiving input data (201) relating to characteristics of the patient via an input interface (101) , preferably image data of the native valve; receiving input data (202) , preferably image data, relating to the position and / or orientation of the prosthetic cardiac valve (2) with respect to the patient, preferably in the vicinity of the final position;- preferably, receiving input data (202) relating to characteristics of the release of the prosthetic cardiac valve (202) from the delivery tool;- determining orientation data (300) relating to the expected orientation of the prosthetic cardiac valve (2) a partially or fully deployed position with respect to the native valve (1) ;- preferably, displaying an orientation indicator, which indicates the expected orientation of the prosthetic cardiac valve with respect to the native valve.

13. A method for computer-based planning, preparing, monitoring and / or executing of a clinical intervention for implanting a prosthetic cardiac valve (2) in a patient, preferably using a system according to one of claims 1 to 10, the method comprising the steps of receiving input data (201) relating to characteristics of the patient via an input interface (101) ; receiving input data (202) relating to the orientation of a prosthetic cardiac valve (2) to be implanted with respect to a delivery tool (401) to be used for implantation, and / or input data (202) relating to the orientation of the prosthetic cardiac valve (2) with respect to a loading tool (402) for loading the prosthetic cardiac valve (2) into the delivery tool and / or input data relating to the position and / or orientation of the prosthetic cardiac valve (2) with respect to the patient, preferably in the vicinity of the final position;- preferably, receiving input data (202) relating to the characteristics of the delivery tool and / or relating to the position and / or orientation with respect to the patient;- preferably, receiving input data (202) relating to characteristics of the release of the prosthetic cardiac valve (202) from the delivery tool; preferably receivinginput data (203) relating to the placement of the delivery tool (401) with respect to the patient, in particular before insertion of the delivery tool (401) into the vessel of the patient;- determining orientation data (300) relating to the expected orientation of the prosthetic cardiac valve (2) with respect to the native valve (1) or a feature of a valve environment, in particular to the position of at least one the coronary (RCA, LCA) and / or to the position of at least one commissure (4) , in the final position.

14. A method according to claim 12 or 13 comprising the further step of receiving data relating to the type and / or size of the prosthetic cardiac valve (2) or to local hemodynamics such as pressure and / or flow gradient.

15. A method according to claim 12, 13 or 14 comprising the further step of providing output data (301) , wherein the output data is selected from- output data (301) for displaying orientation data on an output device (104) ,- output data (301) related to an optimized orientation of the prosthetic cardiac valve (2) with respect to the delivery tool, in particular providing signals and / or instructions to move the prosthetic cardiac valve (2) within delivery tool (401) and / or for providing signals and / or instructions for loading into the delivery tool,- output data (301) related to an optimized position of the delivery tool (401) with respect to the patient before insertion of the delivery tool (401) into the vessel of the patient, in particular for providing signals and / or instructions to change the position of the delivery tool (401) with respect to patient, preferablyproviding signals and / or instructions to change the position of the delivery tool (401) with respect to an insertion device,- output data (301) related to an optimized navigation of the delivery tool (401) to the final position of the cardiac valve, in particular providing navigation data in terms of movement instructions, and- output data (301) related a to risk value based on the orientation data (300) .

16. A method according to any of claims 12 to 15 comprising the further step of carrying out a procedure selected from loading the prosthetic cardiac valve or a valve component (2) into the delivery tool; moving and in particular rotating the prosthetic cardiac valve (2) with respect to the loading tool; moving and in particular rotating the prosthetic cardiac valve (2) with respect to the delivery tool, in particular within the delivery tool.

17. A method according to any of claims 12 to 16 comprising at least one further step of carrying out a procedure selected from- positioning the delivery tool (401) with respect to the patient,- navigating the delivery tool (401) to the final position- withdrawing the delivery tool from the vicinity of the final position,- rotating the delivery tool, preferably in the descending aorta,- interrupting or stopping the valve deliveryretrieving the valve or a valve component.

18. A method according to any of claims 12 to 17 comprising the step of receiving cardiac valve data (202) , wherein the cardiac valve data (202) is selected from- an orientation of a characteristic feature of the prosthetic cardiac valve (2) during delivery,- an annular position of a characteristic feature of the prosthetic cardiac valve (2) placed in a delivery device with respect to the delivery device, and- an annular position of characteristic feature of the prosthetic cardiac valve (2) with respect to a loading device for loading the prosthetic cardiac valve to the delivery device, in particular a crimping device.

19. A method according to any of claims 12 to 18 comprising the further step of creating a virtual model representing a body part involved in the procedure and the prosthetic cardiac valve (2) to represent the orientation data (300) .

20. A computer program comprising program code for carrying out the steps of the method according to any one of the claims 12 to 19 when the program is executed on a computer of a system according to one of claims 1-10 and / or an assembly according to claim 11.

21. A computer program product which can be loaded directly into an internal memory of a digital computer, and which comprises software code portions executing the method steps of at least one of the claims 12 to 19 when the program is running on the digital computer of a system according to one of claims 1-10 and / or an assembly according to claim 11.

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