Patent Description:
Non-invasive percutaneous implantation of cardiac devices poses certain challenges to physicians. As opposed to surgically invasive procedures, such as, for example, open heart surgery, physicians performing non-invasive cardiac implantation procedures have a limited field of view and are generally limited to guidance during the procedure using images generated by two-dimensional (2D) imaging modalities (e.g., ultrasound, fluoroscopy, etc.). Because physicians are typically limited to 2D imaging during the performance of a procedure, proper periprocedural planning and evaluation is required to accurately assess and determine, for example, the size of certain anatomical structures and the type(s) and/or size(s) of devices to be used during the procedure (e.g., catheters).

As with in-procedure guidance, however, conventional periprocedural planning technology has generally been based on imaging platforms and modalities that employ 2D imaging. Accordingly, like the implantation procedure itself, periprocedural planning for such procedures poses challenges to physicians due to the inherent limitations of the conventional 2D imaging that is used.

Accordingly, there is a need for a periprocedural planning method and system that minimizes and/or eliminates one or more of the above-identified deficiencies in conventional periprocedural planning methodologies/techniques.

<CIT> describes a method of analyzing hollow anatomical structures for percutaneous implantation.

<CIT> describes a method for pre-planning and performing a cardiac procedure on a heart.

"<NPL>, describes multidetector computed tomography of the left atrial appendage.

<CIT> describes a method for valve quantification using a 3D heart model.

<CIT> describes evaluating prosthetic heart valve placement.

The invention is defined by appended independent claims <NUM>, <NUM> and <NUM>. There is provided a method for selecting a medical device for use in the performance of a medical procedure involving the left atrial appendage, LAA, of a patient's heart according to claim <NUM>. There is also provided a corresponding computer-readable storage medium according to claim <NUM> and system according to claim <NUM>.

According to one embodiment, a method for selecting a medical device for use in the performance of a medical procedure is provided. The method comprises acquiring image data relating to an anatomical region of interest of a patient's body, generating a multi-dimensional depiction of the anatomical region of interest using the acquired image data, defining a plurality of points relative to the multi-dimensional depiction, determining one or more measurements based on the defined plurality of points, and selecting a medical device to be used based on the determined measurements.

According to another embodiment, a non-transitory, computer-readable storage medium storing instructions thereon is provided. The stored instructions are such that when they are executed by one or more electronic processors, the one or more processors are caused to carry out the method of: acquiring image data relating to an anatomical region of interest of a patient's body; generating a multi-dimensional depiction of the anatomical region of interest using the acquired image data; defining a plurality of points relative to the multi-dimensional depiction; determining one or more measurements based on the defined plurality of points; and selecting a medical device to be used based on the determined measurements.

According to yet another embodiment, a system for selecting a medical device of use in a medical procedure is provided. The system comprises an electronic processor and an electronic memory device electrically coupled to the electronic processor and having instructions stored therein. The processor is configured to access the memory device and execute the instructions stored therein such that it is operable to acquire image data relating to an anatomical region of interest of a patient's body, generate a multi-dimensional depiction of the anatomical region of interest using the acquired image data, define a plurality of points relative to the multi-dimensional depiction, determine one or more measurements based on the defined plurality of points, and select a medical device to be used based on the determined measurements.

One or more embodiments of the invention will hereinafter be described in conjunction with the appended drawings, wherein like designations denote like elements, and wherein:.

The system and method described herein can assist physicians in pre-operational planning (also referred to as "peri procedural planning") of percutaneous procedures, for example and without limitation, procedures involving the implantation of medical devices such as prosthetic heart valves, left atrial appendage (LAA) occlusion devices, and the like. Generally, the system and method described herein use advanced imaging and modeling strategies to accurately assess the location and size of various anatomical structures of interest and to determine or select an ideal or optimal type and size of medical device (e.g., catheter) to be used in the performance of a medical procedure (e.g., implantation procedure) that is specific to the particular patient on which the procedure is to be performed. Although the system and method may be applicable to planning for and evaluating a variety of procedures, of particular applicability are procedures involving the LAA, and in particular the implantation of device for occluding the LAA. Accordingly, the description below will be primarily with respect to the selection of a medical device in the form of catheter that is used to deliver an occlusion device to the LAA. It will be appreciated, however, that various teachings set forth herein could also be applied to any number of other procedures, both cardiac-related and otherwise. For example, the teachings may be applied to the selection a catheter for delivering a prosthetic mitral valve to the mitral annulus of the patient's heart. Thus, it will be appreciated that the present disclosure is not intended to be limited to the use of the system and method described herein for any particular type of procedure.

For purposes of context, <FIG> illustrates a portion of a human heart <NUM> including the LAA <NUM>, the left atrium <NUM>, the left ventricle <NUM>, the right ventricle <NUM>, the right atrium <NUM>, the interatrial wall <NUM>, and the inferior vena cava (IVC) <NUM>. The LAA is a pocket of sorts that receives blood from, and drains blood into, the left atrium. Although the LAA does not contribute to or serve an important function in the operation of the heart, it is a site of concern as it relates to cardiac thrombosis. More specifically, the LAA provides an area within the heart where blood may collect or pool, coagulate, and form a clot. It is well known that blood clots and other emboli traveling through the bloodstream of a patient can have deleterious effects. A clot in the LAA may migrate from the LAA into the left atrium, pass through the mitral valve into the left ventricle, travel through the aortic valve into the aorta and enter the patient's bloodstream where it may obstruct blood flow to, for example, the heart, lungs, or brain, potentially causing heart attacks, strokes, or other undesirable occurrences.

To mitigate against the migration of clots from the LAA, procedures can be performed to occlude the LAA. For example, an occlusion device, such as, for example, the Watchman® device commercially available from Boston Scientific may be placed and secured at or near the ostium of the LAA. As is known in the art, a special elongate medical device (e.g., a catheter) may be used to deliver such an occlusion device to the appropriate location. In at least one embodiment of the system and methodology described herein, the system and method can be used to, for example, determine or select an ideal or optimal type and size of the catheter that is used in the delivery of the occlusion device to the LAA.

<FIG> depicts an illustrative embodiment of a system <NUM> for determining or selecting a medical device to be used in the delivery of a medical device to an anatomical region of interest of a patient's body. In an embodiment, the medical device may comprise an implantable device such as a prosthetic heart valve (e.g. a prosthetic mitral valve) or an occlusion device (e.g., an LAA occlusion device), and the anatomical region of interest is at least a region of the patient's heart. In the illustrative embodiment, the system <NUM> comprises, among potentially other components, an electronic control unit (ECU) <NUM>, a display device <NUM>, and one or more user interface devices <NUM>.

The ECU <NUM> may comprise one or more electronic processors <NUM> having one or more electrical inputs and one or more electrical outputs. The electronic processor <NUM> may comprise any suitable electronic processor known in the art (e.g., a microprocessor, a microcontroller, an ASIC, etc.) that is configured to execute electronic instructions.

The ECU <NUM> may further include, or be electrically connected to and/or configured to access, an electronic memory device <NUM>. The memory device <NUM> may be part of or electrically connected to and/or accessible by the processor <NUM>. The electronic memory device <NUM> may comprise any suitable memory device known in the art and may store a variety of data, information, and/or instructions therein or thereon. In an embodiment, the memory device <NUM> has information and instructions for one or more of software, firmware, programs, algorithms, scripts, applications, data structures (e.g., look-up tables) etc. stored therein or thereon that may govern and/or facilitate all or part of the methodology described herein. In at least some embodiments, the memory device <NUM> may comprise a computer-readable storage medium (e.g. a non-transitory or non-transient storage medium) that may comprise any mechanism for storing information in a form readable by a machine or electronic processors/computational devices (e.g., processor <NUM>), including, without limitation: a magnetic storage medium (e.g. floppy diskette); optical storage medium (e.g. CD-ROM); magneto optical storage medium; read only memory (ROM); random access memory (RAM); erasable programmable memory (e.g. EPROM ad EEPROM); flash memory; or electrical or other types of medium for storing such information/instructions. In addition, program instructions may be communicated using optical, acoustical, or other form of propagated signal (e.g., carrier waves, infrared signals, digital signals, or other types of signals or mediums).

In any event, in an embodiment, the processor <NUM> may access the memory device <NUM> and execute and/or use that or those instructions and information to carry out or perform some or all of the functionality and methodology describe herein.

The display device <NUM> may comprise any number of display devices known in the art, for example and without limitation, liquid crystal display (LCD), cathode ray tube (CRT), plasma, or light emitting diode (LED) monitors or displays. The display device <NUM> is electrically connected or coupled to the ECU <NUM> and is configured to be controlled by the ECU <NUM> such that images, models, or depictions of, for example, anatomical structures generated, obtained, or acquired by the ECU <NUM>-including those used in performing the method described below-may be displayed thereon and may be used for the purposes described herein. Additionally, in an embodiment wherein the ECU <NUM> may be configured to generate an interactive graphical user interface (GUI) that allows, for example, a physician to manipulate images or models displayed on the display device (e.g., rotating/moving models, sectioning models, hiding portions of the models, defining points or planes relative to models/depictions, etc.), facilitate the determining measurements, etc., the display device <NUM> may also display such a GUI. In any event, the display device <NUM> is configured to receive electrical signals from the ECU <NUM> and to display content represented by the received signals which may be viewed by, for example, a physician.

The user interface device(s) <NUM> may comprise any number of suitable devices known in the art. For example, and without limitation, the user input device(s) <NUM> may comprise one or a combination of a touch screen (e.g., LCD touch screen), a keypad, a keyboard, a computer mouse or roller ball, and/or a joystick, to cite a few possibilities. In certain implementations, the display device <NUM> and user input device <NUM> may be combined together into a single device such that they are one in the same. Regardless of the particular form the user interface device(s) take, the user input device(s) <NUM> may be electrically connected or coupled (e.g., via wired or wireless connections) to the ECU <NUM>, and are configured to facilitate communication between a user (e.g., physician) and the system <NUM>, and the ECU <NUM> thereof, in particular. More particularly, the user interface device(s) <NUM> may allow a physician to manipulate images or models/depictions displayed on the display device <NUM> (e.g., hiding portions of models/depictions, defining points or planes relative to models/depictions, rotating/moving models/depictions, etc.), to select or command the determination of measurements relating to anatomical structures represented in models/depictions displayed on the display device <NUM>, etc..

While certain components of the system <NUM> have been described above, it will be appreciated that in some implementations, the system <NUM> may include more or fewer components than are included in the arrangement described above. Accordingly, the present disclosure is not intended to be limited to any particular implementation(s) or arrangement(s) of the system <NUM>.

Turning now to <FIG>, there is shown an illustrative embodiment of a method (method <NUM>) for determining or selecting a medical device to be used in the performance of a medical procedure. More particularly, <FIG> illustrates a method of selecting an elongate medical device (e.g., catheter) to be used in the performance of a procedure during which a medical device is delivered to and implanted within a structure of interest located in a particular anatomical region of a patient's body. In a particular illustrative embodiment, the device to be implanted is an LAA occlusion device, and thus, the anatomical region in which the structure of interest (i.e., the LAA) is located includes at least a portion of the patient's heart. For purposes of illustration, the description below will be primarily with respect to selecting a catheter for use in delivering and placing an LAA occlusion device. It will be appreciated, however, that the methodology described herein may be used to evaluate the placement of other devices, some of which may be described below.

In at least some embodiments, all of the steps of method <NUM> may be performed or carried out by an appropriately or suitably configured system, for example and without limitation, the system <NUM> described above, either alone or in conjunction with input from a user (e.g., physician). In other embodiments, however, some, but not all, of the steps may be performed or carried out by different systems such that certain steps may be performed by one system (e.g., system <NUM>), and other steps may be performed by one or more other suitable systems. For purposes of illustration, the description below will be primarily with respect to an embodiment wherein the method <NUM> is performed by the system <NUM> (and the performance of some or all of the steps of the method <NUM> is/are facilitated at least in part by software stored in, for example, the memory device <NUM> of the system <NUM>), either alone or in conjunction with user input. It will be appreciated, however, that the present disclosure is not limited to such an embodiment. Additionally, it will be appreciated that unless otherwise noted, the performance of method <NUM> is not meant to be limited to any one particular order or sequence of steps, or to any particular component(s) for performing the steps.

In an embodiment, method <NUM> includes a step <NUM> of acquiring image data relating to an anatomical region of the patient's heart that may include at least portions of the structure in which a medical device is to be implanted. For instance, in an embodiment where an LAA occlusion device is to be implanted in the LAA of a patient's heart, the image data acquired in step <NUM> may relate to at least portions of the LAA, the left atrium, the right atrium, and the inferior vena cava (IVC) of the patient's heart.

In an illustrative embodiment, the image data comprises computed tomography (CT) image data, and more particularly, two-dimensional (2D) CT data. It will be appreciated, however, that in other embodiments, the image data may comprise data acquired using an imaging modality other than CT, for example, magnetic resonance imaging (MRI), echocardiogram imaging, or another suitable imaging modality. Accordingly, the present disclosure is not intended to be limited to any particular type of image data; however, for purposes of illustration and clarity, the description below will be primarily with respect to an embodiment wherein CT image data is used. Additionally, in an embodiment, the image data may be acquired during the diastolic phase of the patient's cardiac cycle. It will be appreciated, however, that in other embodiments, image data may be additionally or alternatively acquired during the systolic phase of the cardiac cycle. In any event, one or more 2D images or views of the anatomical region to which the image data acquired in step <NUM> corresponds may be generated or produced from the acquired image data. <FIG> show examples of such images taken along different planes of the patient's heart, wherein <FIG> is an image taken along the coronal plane, <FIG> is an image taken along the axial plane, and <FIG> is an image taken along the sagittal plane.

In a step <NUM>, that or those 2D images may be used to identify and define one or more anatomical structures shown therein. For example, using one or more of the 2D images shown in <FIG>, the fossa ovalis of the patient's heart may be located/identified, and the boundary of the fossa ovalis defined. As shown in <FIG>, the boundary of the fossa ovalis may be defined by placing one or more markers <NUM> onto the image at locations corresponding to points along the interatrial septum disposed between the left atrium and right atrium. In addition to defining the fossa ovalis, these markers also represent potential insertion points through the interatrial septum for the medical device being selected using method <NUM>. (Because during certain procedures (e.g., LAA-related procedures), the medical device has to cross through the interatrial septum from the right atrium to the left atrium. ) In an embodiment, once a marker <NUM> is placed in one view or image of an anatomical region, it automatically appears in other views/images of the anatomical region if the location corresponding to the marker <NUM> is visible in that or those other views, as is shown in <FIG>.

An anatomical structure (e.g., the fossa ovalis) may be defined by the placement of the one or more markers <NUM> in a number of ways. For example, one or more markers <NUM> may be placed automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable image processing software/techniques. In other embodiments, the one or more markers <NUM> may be placed by a user (e.g., physician). More specifically, a 2D image may be displayed on the display device <NUM> and the user may place one or more markers <NUM> thereon using the user interface device(s) <NUM> of the system <NUM>. For example, the user may manipulate a computer mouse to move a cursor to a desired location in the displayed image and "click" the mouse to place a marker <NUM>.

While certain techniques or implementations for defining an anatomical structure of interest have been provided above, it will be appreciated that any suitable technique(s) for doing so may be used. Accordingly, the present disclosure is not intended to be limited to any particular technique(s) for doing so.

In any event, the performance of steps <NUM> and <NUM> may be facilitated at least in part by software stored in, for example, the memory device <NUM> of the system <NUM>. In an embodiment, this software may comprise a software program commercially available from Materialise NV under the name Mimics®; though any other suitable software may certainly be used instead.

Following step <NUM>, and in at least some embodiments, following both step <NUM> and step <NUM>, method <NUM> may proceed to a step <NUM> of acquiring one or more depictions/models of an anatomical region of interest of the patient's body. Accordingly, as shown in <FIG>, in an embodiment, step <NUM> comprises acquiring one or more depictions or models <NUM> of at least a portion of the patient's heart that includes, among other structures, the LAA <NUM>, the left atrium <NUM>, and the right atrium <NUM>. The model(s) or depiction(s) <NUM> acquired in step <NUM> may also include markers used in step <NUM> to define one or more structures of interest (e.g., the boundary of the fossa ovalis). Accordingly, the depiction shown in <FIG> includes at least some of the markers <NUM> placed in step <NUM> to define the fossa ovalis of the patient's heart. In an embodiment, the depiction(s) <NUM> comprise one or more computer-generated models of the anatomical region of interest, for example, one or more multi-dimensional models (e.g., one or more three-dimensional (3D) models). For purposes of illustration and clarity, the description below will be with respect to an embodiment wherein the acquired depiction(s) <NUM> comprise a 3D model of the anatomical region of interest. It will be appreciated, however, that in other embodiments, different types of depictions may be used (e.g., computer-generated models other than 3D models).

In an embodiment where a 3D model is acquired in step <NUM>, that model may be acquired in a number of ways. One way is by obtaining a previously-generated model from a memory device, for example, the memory device <NUM> of the system <NUM>. Another way is by generating the model from image data, for example 2D image data. In the latter instance, the image data may be the same image data acquired in step <NUM> or alternatively may be other image data (e.g., 2D CT image data) acquired as part of step <NUM>. In either instance, the model may be generated using techniques well known in the art, such as, for example, that or those techniques described in <CIT>; and in an embodiment, may be generated by, for example, the ECU <NUM> of the system <NUM>, and the processor <NUM> thereof, in particular. Accordingly, it will be appreciated that the present disclosure is not intended to be limited to any particular way(s) of acquiring the one or more depictions in step <NUM>.

Regardless of how the one or more depictions/models <NUM> is/are acquired in step <NUM>, in an embodiment, the acquired depictions <NUM> (e.g., the single 3D model) may be generated by and/or copied into or used by a suitable software program for performing the steps below. An example of such software is that commercially available from Materialise NV under the name <NUM>-Matic STL. As briefly described above, if applicable, representations of one or more markers <NUM> placed in step <NUM> to define an aspect (e.g., boundary) of one or more anatomical structures may also be imported into the model/depiction <NUM> acquired in step <NUM>.

In at least some embodiments, the depiction(s) <NUM> acquired in step <NUM> may be such that portions of the depiction representative of different anatomical structures may be selectively hidden so as to provide, for example, a better or clearer view of other anatomical structures. For example, the depiction shown in <FIG> includes the LAA <NUM>, the left atrium <NUM>, and the right atrium <NUM>. In the depictions shown in, for example, <FIG>, however, the right atrium is hidden so as to provide a better, clearer view of the LAA <NUM> and left atrium <NUM>. Accordingly, the present disclosure is not intended to be limited to the acquisition of any particular type of depiction(s) (e.g., static or dynamic) in step <NUM>.

Once a depiction of the anatomical region of interest is acquired in step <NUM>, the method <NUM> moves to a step <NUM> of using the acquired depiction <NUM> to define one or more planes corresponding to one or more anatomical structures shown in the acquired depiction <NUM>. For example, in an embodiment such as that illustrated in <FIG>, step <NUM> comprises defining a plane that contains the ostium of the LAA <NUM>. In an embodiment, the plane being defined does not correspond to or contain what is conventionally considered by those of ordinary skill in the art to be the ostium of the LAA (referred to below as the "false ostium"), which is the opening of the LAA immediately adj acent the left atrium. Rather, the "ostium" of the LAA for purposes of this disclosure (referred to below as the "true ostium") may comprise the portion or point of the LAA that has the greatest circumference/perimeter, that is distal of the conventional "ostium" of the LAA (i.e., further into the LAA and away from the left atrium than the conventional ostium), and that has a plane that is perpendicular to the centroid of the LAA. For purposes of illustration, <FIG> illustrates a plane <NUM> containing the false ostium and a plane <NUM> containing the true ostium (plane <NUM> containing the true ostium is also shown in <FIG>).

The plane <NUM> of the true ostium may be defined in a number of ways. One way is by tracing the perimeter of the LAA <NUM> at its largest point. Another way is by placing and positioning a cross-sectional plane at the desired location in or on the depiction <NUM>. In either case, the plane <NUM> may be defined automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable image processing software/techniques. Alternatively, the plane <NUM> may be defined by a user (e.g., physician) manipulating the user interface device(s) <NUM> of the system <NUM>. More specifically, the depiction <NUM> acquired in step <NUM> may be displayed on the display device <NUM> and the user may trace the perimeter of the LAA <NUM> or place a cross-sectional plane onto the depiction <NUM> using the user interface device(s) <NUM>. For example, the user may manipulate a computer mouse to move a cursor to a desired location in the displayed depiction <NUM> and "click" the mouse to place a cross-sectional plane at that location. Regardless of how the plane <NUM> is defined, in an embodiment, a representation of the defined plane <NUM> may be displayed on the depiction <NUM> for the user to view, as shown in <FIG> and <FIG>.

While certain techniques or implementations for defining the true ostium plane <NUM> of the LAA <NUM> have been provided above, it will be appreciated that any suitable technique(s) for doing so may be used. Accordingly, the present disclosure is not intended to be limited to any particular technique(s) for doing so.

Another plane that may be defined in step <NUM> is a plane that contains the mitral annulus of the patient's heart; that plane being referred to herein as the "mitral plane. " Alternatively, the mitral plane may be defined in a step of method <NUM> performed before or after step <NUM>, or may not be defined at all. In an instance where the mitral plane is defined, it may be done so in a number of ways using any number of techniques known in the art. For example, in one embodiment, step <NUM> may comprise acquiring image data relating to an anatomical region of the patient's heart that includes, for example, the left ventricle, left atrium, and aorta of the patient's heart. The image data may be the same image data acquired in step <NUM> or comprise different image data. In either instance, the image data may comprise CT image data, and more particularly, 2D CT image data. It will be appreciated, however, that in other embodiments, the image data may comprise data acquired using a suitable imaging modality other than CT, for example, one or more of those imaging modalities identified elsewhere herein. Accordingly, the present disclosure is not intended to be limited to any particular type of image data. However, for the purposes of illustration and clarity, the description below will be with respect to the use of CT data. Additionally, in an embodiment, image data may be acquired for both the diastolic and systolic phases of the cardiac cycle, and in such an embodiment, the mitral plane may be defined for each phase. Alternatively, data may be acquired and the mitral plane defined for only one of the diastolic and systolic phases.

In an embodiment, one or more 2D images generated from the acquired CT image data may be used to define the mitral plane. More particularly, a 2D image may be used to define a certain number of points (e.g., three (<NUM>) points) that may be used to define the mitral plane. In an embodiment, one or more predetermined landmarks (e.g., anatomical landmarks) may be used to identify/define the plane-defining points. The particular landmarks used may depend, at least in part, on the nature of structure proximate the mitral annulus. For example, in an instance wherein the structure is a native mitral valve, the landmarks may include areas of calcification and/or leaflet tips and/or insertion points at the mitral annulus of the native valve, to cite few possibilities. In an instance wherein the structure comprises a previously-implanted device or object, for example, a mitral ring, the landmarks may comprise that device or at least certain portions thereof. Finally, in an instance wherein the structure comprises a previously-implanted prosthetic mitral valve, the landmarks may comprise portions of the previously-implanted valve, for example, the tips of the struts of the previously-implanted valve. In any event, the plane-defining points may be defined or identified in a number of ways.

In one embodiment, the points may be defined automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable image processing software/techniques. In other embodiments, the points may be defined by a user (e.g., physician). More specifically, the 2D image may be displayed on the display device <NUM> and the user may define the plane-defining points using the user interface device(s) <NUM> of the system <NUM>. For example, the user may manipulate a computer mouse to move a cursor to a desired location on the image and to "click" the mouse to define a point. In any event, once the plane-defining points are defined, a plane containing all of the defined points can be defined as the mitral plane. In at least some embodiments, the mitral plane can be represented on a 2D image by, for example, a spline. While certain techniques or implementations for defining the mitral plane-defining points, and thus, defining the mitral plane itself have been provided above, it will be appreciated that any suitable technique(s) for doing so may be used. Accordingly, the present disclosure is not intended to be limited to any particular technique(s) for doing so.

In another embodiment, rather than using a 2D image to define the mitral plane, the depiction <NUM> acquired in step <NUM> may be used. For example, a cross-sectional plane may be positioned at the desired location in or on the depiction <NUM>. In such an embodiment, the mitral plane may be defined automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable image processing software/techniques. Alternatively, the plane may be defined by a user (e.g., physician) manipulating the user interface device(s) <NUM> of the system <NUM>. More specifically, the depiction <NUM> acquired in step <NUM> may be displayed on the display device <NUM> and the user may manipulate a computer mouse to move a cursor to a desired location in the displayed depiction <NUM> and "click" the mouse to place a cross-sectional plane at that location. In such an instance, in an embodiment wherein portions of the depiction <NUM> acquired in step <NUM> may be hidden, structures that were previously hidden during the performance of other steps of method <NUM> may be displayed in order to facilitate the performance of step <NUM> (e.g., the left ventricle, the mitral valve, the mitral annulus, etc.).

Regardless of how the mitral plane is defined, in an embodiment, a representation of the defined mitral plane may be displayed on the depiction <NUM>, as shown, for example, in <FIG> wherein reference numeral <NUM> corresponds to the defined mitral plane. While certain techniques or implementations for defining the mitral plane <NUM> have been provided above, it will be appreciated that any suitable technique(s) for doing so may be used. Accordingly, the present disclosure is not intended to be limited to any particular technique(s) for doing so. Additionally, the performance of step <NUM> may be facilitated at least in part by software stored in, for example, the memory device <NUM> of the system <NUM>. In an embodiment, this software may comprise a software program commercially available from Materialise NV under the name 3Matic STL or Mimics®; though any other suitable software may certainly be used instead.

While the description of step <NUM> has thus far been with respect to the defining of planes containing or corresponding to certain specific anatomical structures, it will be appreciated that in other embodiments, additional or alternative planes may be defined. Accordingly, the present disclosure is not necessarily limited to the defining of any particular planes in step <NUM>, but rather any number of suitable planes may be defined in step <NUM>.

Turning back to <FIG>, in an embodiment, the method <NUM> may further include an optional step <NUM> of moving the true ostium plane <NUM> defined in step <NUM> along the object coordinate system (X&Y) until the origin of the plane <NUM> is in the center of the true ostium of the LAA <NUM>. In an embodiment, a hollow body blood volume model may be used to perform this step. In an embodiment, step <NUM> may be performed automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable image processing software/techniques. Alternatively, the step <NUM> may be performed by a user (e.g., physician) manipulating the user interface device(s) <NUM> of the system <NUM>. More specifically, the user may manipulate a computer mouse to move the plane <NUM> to a desired point or location corresponding to the center of the true ostium of the LAA in the displayed depiction.

Whether or not method <NUM> includes step <NUM>, and with reference to <FIG> and <FIG>, in an embodiment method <NUM> includes a step <NUM> of duplicating the true ostium plane <NUM> to create a duplicate plane <NUM>, and moving the duplicate plane <NUM> along the objects coordinate system perpendicular to the plane <NUM> (e.g., in the Z direction) to a point that is outside or beyond the LAA <NUM> in the depiction <NUM>. The plane <NUM> may hereinafter be referred to as the perpendicular offset plane <NUM> or the offset true ostium plane <NUM>. In an embodiment, the distance between the LAA <NUM> and the point outside or beyond the LAA <NUM> may be on the order of a few centimeters, though the present disclosure is not intended to be limited to any particular distance. In an embodiment, step <NUM> may be performed automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable image processing software/techniques. Alternatively, the step <NUM> may be performed by a user (e.g., physician) manipulating the user interface device(s) <NUM> of the system <NUM>. More specifically, the user may manipulate a computer mouse to cause the plane <NUM> to be duplicated to and to then move the duplicate plane <NUM> to a desired point or location beyond the LAA <NUM> in the displayed depiction <NUM>, thereby establishing the perpendicular offset plane <NUM>.

In an embodiment, method <NUM> may further include a step <NUM> of defining a plurality of points relative to the depiction <NUM> (i.e., in/on or in the vicinity of the depiction <NUM>), two or more which will be used to determine or calculate one or more measurements relative to one or more anatomical structures that will, in turn, be used in the selection of a medical device to be used in the performance of a medical procedure.

In an embodiment such as that illustrated in <FIG>, step <NUM> includes a number of substeps, including identifying and defining the origin(s) of one or more planes. For example, in an illustrative embodiment, step <NUM> includes a substep of identifying and defining the origin of one or both of the true ostium plane <NUM> and the perpendicular offset plane <NUM>. Step <NUM> may also include a substep of identifying and defining the origin of a plane containing the fossa ovalis (i.e., the centroid of the fossa ovalis (also referred to as the origin of the fossa ovalis plane)) and/or the origin of a plane containing the ostium of the IVC (i.e., the centroid of the IVC ostium (also referred to as the origin of the IVC ostium plane)), which are respectively identified in <FIG> by reference numerals <NUM>, <NUM>. In other embodiments, the origin(s) of one or more planes in addition to or other than those mentioned above may be identified and defined. In any event, each of the substeps of step <NUM> may be performed in a number of ways.

One way is by placing a point or marker <NUM> on or at the origin/centroid of the planes/structures of interest, as shown in <FIG> wherein marker 54a corresponds to the origin/centroid of the fossa ovalis and marker 54b corresponds to the origin/centroid of the IVC ostium. In an embodiment, one or more of the substeps may be performed automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable image processing software/techniques. Alternatively, one or more of the substeps may be performed by a user (e.g., physician) manipulating the user interface device(s) <NUM> of the system <NUM>.

More specifically, the user may manipulate a computer mouse to rotate or move the depiction <NUM> displayed on the display <NUM> and/or move a cursor to a desired location in the displayed depiction <NUM> corresponding to the desired origin/centroid and "click" the mouse to place a point or marker at that location. As it relates to identifying/defining the origin of the plane that contains the fossa ovalis, in an embodiment such as that shown in <FIG>, the markers <NUM> corresponding to the boundary of the fossa ovalis defined, for example, in step <NUM> may be used to guide the identification and definition of the origin/centroid 54a. In another embodiment such as that shown in <FIG>, a thickness analysis tool may be used to identify/define the origin/centroid 54a of the fossa ovalis. More specifically, such a tool may be used to identify the thinnest or narrowest area of the fossa ovalis. For example, the tool may generate a color map wherein different colors represent different thicknesses (e.g., red being the thinnest and green is the thickest). Using this map, the thinnest point can be identified and considered to be the origin/centroid 54a of the fossa ovalis, and a plane including that origin/centroid 54a can be defined. In another embodiment, the plane may be defined using image data, for example CT data. More particularly, using a 2D CT image, a point where the left and right atrium meet can be identified in an image and a plane can be defined that includes that point. Accordingly, it will be appreciated that any number of techniques may be used.

Accordingly, it will be appreciated that the present disclosure is not intended to be limited to any particular way or technique of performing step <NUM>. Additionally, it will be appreciated in view of, for example, <FIG>, <FIG>, and <FIG> that in some embodiments wherein portions of the depiction <NUM> acquired in step <NUM> may be hidden, structures that were previously hidden during the performance of other steps of method <NUM> may be displayed in order to facilitate the performance of step(s) <NUM>.

In at least some embodiments, the markers <NUM> corresponding to the identified/defined origins/centroids may be displayed on the depiction for the user to view, regardless of how the origins/centroids are identified/defined.

While the description above is with respect to the identification/definition of the origins/centroids of certain specific structures/planes, it will be appreciated that in other embodiments, such as, for example, those described below, the origin(s)/centroid(s) of additional or alternate structures/planes may be identified/defined. Accordingly, the present disclosure is not intended to be limited to the identification/definition of the origin(s)/centroid(s) of any particular structures/planes in step <NUM>.

As shown in <FIG> and with reference to <FIG>, in an embodiment, method <NUM> further includes a step <NUM> of duplicating the mitral plane <NUM> defined in step <NUM> and moving the duplicate plane or a representation of the plane <NUM> (represented by reference numeral <NUM> in <FIG>) along the objects coordinate system perpendicular to the plane <NUM> (e.g., in the Z direction) to a point such that the representation <NUM> of the plane <NUM> is both offset from the mitral plane <NUM> and aligned or level with the origin of the true ostium plane <NUM> (represented by reference numeral <NUM>), as is shown in <FIG>. The representation <NUM> comprising an offset mitral plane.

In at least some embodiments, method <NUM> may further include a step <NUM> of duplicating the mitral plane <NUM> a second time and moving the second duplicate plane or a representation of the plane <NUM> (represented by reference numeral <NUM> in <FIG>) along the objects coordinate system perpendicular to the plane <NUM> (e.g., in the Z direction) to a point such that the representation <NUM> of the plane <NUM> is both offset from the mitral plane <NUM> and the representation <NUM> of the plane <NUM>, and is also aligned or level with the origin/centroid 54a of the fossa ovalis, as is shown in <FIG>. The representation <NUM> also comprising an offset mitral plane.

Whether method <NUM> includes one or both of steps <NUM>, <NUM>, one or both of those steps may be performed automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable image processing software/techniques. Alternatively, one or both of steps <NUM>, <NUM> may be performed by a user (e.g., physician) manipulating the user interface device(s) <NUM> of the system <NUM>. More specifically, the user may manipulate a computer mouse to cause the mitral plane <NUM> shown on the depiction <NUM> displayed on the display <NUM> of the system <NUM> to be duplicated one or more times, and to then move (e.g., drag) the duplicate mitral plane(s) (i.e., representation <NUM> and/or <NUM>) to the desired point(s) or location(s) to establish one or more offset mitral planes. Additionally, it will be appreciated that in some embodiments wherein portions of the depiction acquired in step <NUM> may be hidden, structures that were previously hidden during the performance of other steps of method <NUM> may be displayed in order to facilitate the performance of step(s) <NUM>, <NUM>.

Using, at least in part, the points identified or defined in step <NUM>, method <NUM> comprises a step <NUM> of determining or calculating various measurements, for example, distances between two or more of the defined points and/or angles defined by a combination of points. For example, and with reference to <FIG>, in one embodiment wherein method <NUM> is being used to determine or select a medical device (e.g., catheter) to be used in an LAA-related procedure (e.g., to deliver and place an LAA occlusion device), one or more of the following five (<NUM>) measurements may be determined, and one or more of the determined measurements may be used to determine or select a medical device.

A first measurement, identified as measurement "<NUM>" in <FIG>, is the distance between the point 54b corresponding to the origin/centroid of the IVC ostium (i.e., origin of a plane containing the IVC ostium) and the point 54a corresponding to the origin/centroid of the fossa ovalis (i.e., origin of a plane containing the fossa ovalis).

A second measurement, identified as measurement "<NUM>" in <FIG>, is the distance between the point 54a corresponding to the origin/centroid of the fossa ovalis and the point <NUM> corresponding to the origin of the plane <NUM> of the true ostium.

A third measurement, identified as measurement "<NUM>" in <FIG>, is the angle formed by the point 54b corresponding to the origin/centroid of the IVC ostium, the point 54a corresponding to the origin/centroid of the fossa ovalis, and the point <NUM> corresponding to the origin of the plane <NUM> of the true LAA ostium.

A fourth measurement, identified as measurement "<NUM>" in <FIG>, is the angle formed by the point 54a corresponding to the origin/centroid of the fossa ovalis, the point <NUM> corresponding to the origin of the plane <NUM> of the true LAA ostium, and a point <NUM> corresponding to the origin of the offset LAA true ostium plane <NUM> (also referred to as the offset true ostium plane <NUM>).

And a fifth measurement, identified as measurement "<NUM>" in <FIG>, is the distance between the first and second offset mitral planes <NUM>, <NUM> that intersect with the true ostium plane <NUM> and the origin/centroid 54a of the fossa ovalis, respectively.

It will be appreciated that while certain specific measurements are identified and discussed above, in other embodiments, one or more measurements in addition to or instead of those described above may be determined and used as described below.

For example, and with reference to <FIG>, in an embodiment wherein method <NUM> is used to select a medical device for use in a procedure relating to the mitral valve, method <NUM> may include a step (not shown) that is performed before step <NUM> and that comprises duplicating the plane represented in <FIG> and <FIG> as reference numeral <NUM> that contains the origin/centroid 54a of the fossa ovalis (i.e., fossa ovalis plane), and moving or offsetting the duplicate plane or a representation of the plane <NUM> (represented as reference numeral <NUM> in <FIG> and <FIG>) along its origin until it intersects with an axis <NUM> of the origin of the mitral plane <NUM>. The mitral plane <NUM> is then duplicated yet again, and the duplicated plane or representation of the plane <NUM> (represented by reference numeral <NUM> in <FIG> and <FIG>) is moved or offset to the point at which the offset fossa ovalis plane <NUM> intersects with the axis <NUM>.

As shown in <FIG>, in at least some embodiments, this step may be performed using a view wherein all mitral plane edges and the fossa ovalis plane edge are aligned. In any event, the step described above may be performed automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable image processing software/techniques. Alternatively, the step may be performed by a user (e.g., physician) manipulating the user interface device(s) <NUM> of the system <NUM>. More specifically, the user may manipulate a computer mouse to cause the mitral plane <NUM> and fossa ovalis plane <NUM> displayed on the display <NUM> of the system <NUM> to be duplicated one or more times, and to then move (e.g., drag) the duplicate offset plane(s) to the desired point(s) or location(s). Additionally, it will be appreciated that in some embodiments wherein portions of the depiction acquired in step <NUM> may be hidden, structures that were previously hidden during the performance of other steps of method <NUM> may be displayed in order to facilitate the performance of this step.

In an embodiment wherein method <NUM> includes the step described above, step <NUM> comprises using the points identified in step <NUM>, the planes defined in one or more steps <NUM>, <NUM>, and the intersection point(s) described above to determine or calculate various measurements. For example, and with reference to <FIG> and <FIG>, one or more of the following eight (<NUM>) different measurements may be determined and used to determine select a medical device.

A first measurement is the distance between the original of the mitral plane <NUM> and the origin of the offset mitral plane <NUM> (i.e., the distance between points "A" and "B" in <FIG>).

A second measurement is the distance between the origin of the mitral plane <NUM> and the intersection point of the offset mitral plane <NUM> and the offset fossa ovalis plane <NUM> (i.e., the distance between points "A" and "C" in <FIG>).

A third measurement is the distance between the origin of the offset mitral plane <NUM> and the intersection point of the offset mitral plane <NUM> and the offset fossa ovalis plane <NUM> (i.e., the distance between points "B" and "C" in <FIG>).

A fourth measurement is the angle formed by the points corresponding to the origin of the offset mitral plane <NUM>, the origin of the mitral plane <NUM>, and the intersection point of the offset mitral plane <NUM> and the offset fossa ovalis plane <NUM> (i.e., the angle "BAC" in <FIG>).

A fifth measurement is the angle formed by the points corresponding to the origin of the mitral plane <NUM>, the origin of the offset mitral plane <NUM>, and the intersection point of the offset mitral plane <NUM> and the offset fossa ovalis plane <NUM> (i.e., the angle "ABC" in <FIG>).

A sixth measurement is the angle formed by the points corresponding to the origin of the mitral plane <NUM>, the intersection point of the offset mitral plane <NUM> and the offset fossa ovalis plane <NUM>, and the origin of the offset mitral plane <NUM> (i.e., the angle "ACB" in <FIG>).

A seventh measurement is the angle formed by the points corresponding to the origin/centroid 54b of the IVC ostium, the origin/centroid 54a of the fossa ovalis, and the origin of the mitral plane <NUM> (i.e., the angle at point "D" in <FIG>).

And an eighth measurement is the angle formed by the points corresponding to the origin/centroid 54a of the fossa ovalis, the origin of the mitral plane <NUM>, and the origin of the offset mitral plane <NUM> (i.e., the angle "DAB" in <FIG> and shown as angle "E" in <FIG>.

Again, it will be appreciated that while certain specific measurements are identified and discussed above, in other embodiments, one or more measurements in addition to or instead of those described above may be determined. Additionally, as shown in <FIG> and <FIG>, in at least some embodiments, some or all of the depiction <NUM> acquired in step <NUM> may be hidden to provide a clear view of the measurements being determined in step <NUM>.

Regardless of the particular measurement(s) determined in step <NUM>, in an embodiment, step <NUM> may be performed automatically by the ECU <NUM> of the system <NUM> (e.g., by the processor <NUM> of the ECU <NUM>) using, for example, suitable software/techniques. Alternatively, step <NUM> may be performed by a combination of the ECU <NUM> and user input. More particularly, a user (e.g., physician) may manipulate the user interface device <NUM> to select the measurement(s) to be determined (e.g., select two points between which a distance is to be determined, select three points that define the angle that is to be determined, etc.), and then the ECU <NUM> may determine/calculated the appropriate, selected measurement(s). Accordingly, the present disclosure is not intended to be limited to any particular way of performing step <NUM>.

As illustrated in <FIG>, once the appropriate measurement(s) is/are determined in step <NUM>, method <NUM> proceeds to a step <NUM> of selecting or determining a medical device based on that or those measurements determined in step <NUM>. In an embodiment, a data structure, for example, an empirically-derived look-up table (e.g., a multi-dimensional look-up table) that is configured to correlate the measurement(s) determined in step <NUM> (input(s)) with different types (e.g., sizes, shapes, etc.) of medical devices (output) is used to select/determine the appropriate medical device. In an embodiment, the data structure may be stored in a memory of the system <NUM> (e.g., the memory <NUM> of the ECU28), and the processor <NUM> of the ECU <NUM> may be configured to look up the measurements determined in step <NUM> in the data structure to select or determine an appropriate medical device to use. It will be appreciated, however, that other suitable ways/technique for selecting a medical device may certainly be used instead.

In addition to the foregoing, in at least some embodiments, the appropriateness or suitability of one or more insertion points through an anatomical structure and/or one or more medical devices used to perform the medical procedure may be evaluated. In an embodiment, this evaluation may comprise part of the method <NUM>, and thus, the steps of the evaluation process may be performed after one or more of the above-described steps of method <NUM> (e.g., after one or more of steps <NUM>-<NUM>). It will be appreciated, however, that the steps of the evaluation process may also be performed independently of method <NUM>, or may require only some of the steps of method <NUM>. For purposes of illustration only, the description below will be with respect to insertion points through the interatrial septum, and the fossa ovalis in particular, and medical devices comprising catheters (e.g., catheters used in procedures relating to the implantation of LAA occlusion devices). It will be appreciated, however, that the appropriateness of insertion points through other anatomical structures and/or devices other than catheters may be evaluated in the manner described below.

In at least some embodiments, the evaluation process includes a step of identifying or one or more insertion points through the interatrial septum. The depiction <NUM> acquired in step <NUM> or a different depiction acquired in a similar manner as that described in step <NUM> may be used to identify or select one or more possible insertion points. The possible insertion points may be identified or selected in any number of ways, including, for example and without limitation, in the manner described elsewhere above with respect to the identification of markers <NUM>. <FIG> illustrates the depiction <NUM> having a single insertion point represented by marker <NUM>; though it will be appreciated that more than one insertion point may certainly be identified.

Once one or more insertion points are identified, one or more models of one or more medical devices (e.g., catheters) may be selected and imported into the depiction <NUM>. In an illustrative embodiment, the identified insertion points are evaluated individually one at a time, with one or more selected models being imported into the depiction for a given insertion point. In other embodiments, however, multiple insertion points may be evaluated at the same time, with one or more models being imported for each insertion point.

The selection of a model of a device may be carried out in a number of ways. In at least some embodiments, the selection of a model of a particular medical device may be made from a number of different models having different characteristics. For example, in an illustrative embodiment, a particular model may be selected from a series of models representative of devices from different manufactures, devices having different material properties assigned thereto, and/or devices having different shapes, sizes, geometries (e.g., lengths, diameters, curvatures (both number and degrees of curvature(s)), minimum/maximum bend radii, and/or other characteristics). The selection may also be from models of devices used for different procedures. Accordingly, it will be appreciated that the selection of a model (or models) may be based on a number of factors/ characteristics, including, but not limited to, those identified above.

In an embodiment, the models from which a selection is made may be contained in a digital library or database that may be stored in or on a suitable component of the system <NUM>, or a component that is accessible by system <NUM>. In one illustrative embodiment, the library or database containing the models is stored in or on the memory device <NUM> of the ECU <NUM> of the system <NUM>. The model selection may be made automatically by the system <NUM> (i.e., the processor <NUM>) or may be made manually by a user via, for example, the user interface device(s) <NUM>, the display devices <NUM>, or a combination of the user interface device <NUM> and display <NUM>. In the latter instance, a list of possible models may be displayed on the display device <NUM> and a user may manipulate the user interface device <NUM> (or the display device itself) to select the desired model(s). The models in the list may be identified by words describing the model and/or the device represented thereby (e.g., manufacture name, device name, device model number, etc.). Additionally, or alternatively, visual depictions of the models themselves may be displayed (e.g., thumbnail images of the models/devices).

In an illustrative embodiment, one or more user-inputtable or user-selectable fields (e.g., radio buttons, drop-down menus, text boxes for entering information, etc.) may be displayed to allow a user to provide certain information that the system <NUM> can use to narrow down the universe of models from which the selection is made. This may include, for example, the name of a preferred device manufacturer, the name of the procedure to be performed, etc. In response to the user input, the system <NUM> may automatically select the model(s) to be used, or may present a list of models from which a selection can be made by the user.

In view of the foregoing, it will be appreciated that the selection of one or more models of one or more medical devices may be carried out in a number of ways, including, but certainly not limited to, those described above.

In certain embodiments, the selection of a model results in the selected model being imported into the depiction <NUM>, or at least displayed along with the depiction <NUM>. In other embodiments, however, a user must affirmatively command the importation of a selected model by, for example, manipulating an "import" button that may be displayed or disposed on the display <NUM> or on the user interface <NUM>. In an illustrative embodiment, an imported model is automatically placed and positioned within the depiction <NUM> in such a way that it shows how the device represented by the model would be disposed if actually used in the performance of the medical procedure (i.e., it shows the model in the landing position of the device). For example, in an instance wherein the medical procedure involves the implantation of an LAA occlusion device and the model is a model of a catheter used in the performance of such a procedure, the model of the catheter may be placed such that the distal tip of the catheter model is located proximate (i.e., near or in) the LAA ostium. The user may then be able to fine tune the position of the model using, for example, the user interface device <NUM> by translating and/or rotating the model. The system <NUM> may be configured to automatically position the model based on certain pre-defined points within or relative to the depiction <NUM>, including, for example, an identified insertion point through the interatrial septum. These points may include some or all of the points defined in step <NUM> of method <NUM> described above. For example, in <FIG>, the positioning of a model <NUM> within the depiction <NUM> is defined or dictated by a plurality of points defined in step <NUM>, namely, the origin of a plane that contains the IVC ostium, the origin of a plane that contains the fossa ovalis, and the origin of a plane that contains the true ostium of the LAA. In other embodiments, the points used in the automatic placement/positioning of the model may comprise additional and/or different points than those defined in step <NUM> that is/are defined manually by the user or automatically by the system <NUM>.

In other embodiments, rather than the model being automatically placed as described above, the user may be able to manually place the model at one or more desired locations using, for example, the user interface device <NUM>. For example, the user may "click" and "drag" the model to a desired position within the depiction <NUM>. Alternatively, the user may use "translate" and/or "rotate" tools to move the model to a desired location. In such am embodiment, the user may also reposition the model to a different desired location within the depiction <NUM>.

Once one or more device models have been imported for one or more insertion points, the trajectory of each imported model for each respective insertion point can be viewed or determined, and a determination can be made as to the appropriateness of each device and/or the respective insertion point(s). More particularly, <FIG> shows the model <NUM> imported into the depiction <NUM> relative to an insertion point <NUM>. The model <NUM> is placed such that it is positioned at a location corresponding to a desired landing point of the device represented by the model <NUM>. The user may then view the trajectory that the device would have relative to various anatomical structures shown or represented in the depiction <NUM>, and then determine, based at least in part and the trajectory, whether the device represented by the model <NUM>, and/or the insertion point <NUM>, is/are appropriate.

Additionally, or alternatively, the system <NUM>, and the ECU <NUM> thereof in particular, may be configured to make the determination as to the appropriateness of the device and/or insertion point automatically. More specifically, information relating to the device represented by the model <NUM> (i.e., minimum bend radius, maximum diameter, etc.) may be stored in, for example, the memory device <NUM> or another suitable memory device that is part of or accessible by the system <NUM>. The processor <NUM> of the ECU <NUM> of the system <NUM>, or another suitable component of system <NUM> or otherwise, may be configured to access the device information and use it to grade or determine the appropriateness of the device and/or a given insertion point. The points defined in, for example, step <NUM> may also be used along with this information to determine the appropriateness of the device and/or a given insertion point.

If only the appropriateness of the device is being evaluated, and it is determined that the device is appropriate, then the user may select that device for use in performing the procedure. Otherwise, the above-described process may be repeated for a different device, or if multiple devices were being evaluated at the same time, the user may select a device deemed to be most appropriate. If only the appropriateness of the insertion point is being evaluated, and it is determined that the insertion point is appropriate, then the user may select that insertion point as the target insertion point for the procedure. Otherwise, the above-described process may be repeated for a different insertion point, or if multiple insertion points were being evaluated at the same time, the user may select the insertion point deemed to be most appropriate. Finally, if the appropriateness of the device and the insertion point are being evaluated, and it is determined that both a given insertion point and a given device are appropriate, then the user may select that device and insertion point for use in performing the procedure. Otherwise, the above-described process may be repeated for a different device/insertion point combination, or if either multiple devices and/or multiple insertion points were being evaluated at the same time, the user may select the device/insertion point combination deemed to be most appropriate.

Accordingly, it will be appreciated that the appropriateness or suitability of a medical device and/or insertion point through an anatomical structure may be determined in a variety of ways, including, but not limited to, those described above.

It is to be understood that the foregoing is a description of one or more embodiments of the invention. The invention is not limited to the particular embodiment(s) disclosed herein, but rather is defined solely by the claims below. Furthermore, the statements contained in the foregoing description relate to particular embodiments and are not to be construed as limitations on the scope of the invention or on the definition of terms used in the claims, except where a term or phrase is expressly defined above. Various other embodiments and various changes and modifications to the disclosed embodiment(s) will become apparent to those skilled in the art.

Claim 1:
A method for selecting a medical device for use in the performance of a medical procedure involving the left atrial appendage, LAA (<NUM>), of a patient's heart, comprising:
acquiring image data relating to an anatomical region of interest of a patient's body;
generating a multi-dimensional depiction of the anatomical region of interest using the acquired image data;
defining a plurality of points relative to the multi-dimensional depiction, wherein the plurality of points defined in the defining step comprises two or more of the following individual points:
a point (<NUM>) within a plane (<NUM>) that contains a true ostium of the LAA ("true ostium plane"), wherein the point corresponds to the centroid of the true ostium of the LAA, this true ostium being the portion of the LAA having the greatest circumference, and the plane that contains the true ostium being spaced from the conventional ostium of the LAA, namely the opening of the LAA immediately adjacent the left atrium;
a point (<NUM>) within a plane (<NUM>) that is a duplicate of and offset from the true ostium plane in a direction that is perpendicular to the true ostium plane ("offset true ostium plane"), wherein the point corresponds to an origin of the offset true ostium plane, which corresponds to the centroid of the true ostium of the LAA offset in a direction perpendicular to the true ostium plane;
a point (54a) within a plane that contains the fossa ovalis of the patient's heart ("fossa ovalis plane"), wherein the point corresponds to the centroid of the fossa ovalis; or
a point (54b) within a plane that contains the inferior vena cava ("IVC") ostium of the patient's heart ("IVC ostium plane"), wherein the point corresponds to the centroid of the IVC ostium;
determining one or more measurements based on the defined plurality of points; and
selecting a medical device to be used based on the determined measurements, wherein the medical device is a catheter used to deliver an LAA occlusion device to the LAA of the patient's heart.