Navigation with arbitrary catheter geometries and method of contact assessment

A method and system for determining a location of a treatment element relative to an anatomical feature and for estimating contact between the treatment element and the anatomical feature in the context of a navigation system. The system may include a medical device including at least one treatment element and at least one navigation electrode and a navigation system in communication with the one or more navigation electrodes, the navigation system including a processing unit. The processing unit may be programmed to determine a plurality of points that define a surface geometry of the at least one treatment element, calculate a distance between each of the points and a closest point on the anatomical feature, and estimate the likelihood of contact between the points.

CROSS-REFERENCE TO RELATED APPLICATION

TECHNICAL FIELD

The present invention relates to a method and system for determining a location of a treatment element of a medical device and for estimating contact between the treatment element and tissue in the context of a navigation system.

BACKGROUND

In many non-invasive or minimally invasive surgical and treatment procedures, navigating a medical device within a patient's body can be very challenging. Navigation systems are frequently used to help the user identify the location of the medical device and to steer the medical device to the target treatment location. For example, navigation is an important tool in many electrophysiological (EP) procedures because it helps the user understand the placement of the medical device within the cardiac space. Additionally, navigation is often used to place medical devices at areas targeted for thermal treatment and/or ablation.

In many navigation systems, a medical device includes navigation electrodes, which can be detected by the system by a variety of means. The position of these navigation electrodes can be displayed to the user relative to an anatomical structure, such as the endocardial surface of the heart. This navigation capability allows the user to position the medical device relative to the target tissue and subsequently document activity, such as the application of ablative therapy, at that location.

When the medical device is a focal catheter, for instance, the ablating surface may be directly imaged on the navigation system and there is a close, sometimes direct, coupling between the navigation and the delivered therapy. However, navigation electrodes other medical devices, such as balloon catheters, may not exactly correlate with the ablating surface (e.g., the surface of the balloon). Thus, it may be difficult to accurately determine the location of the balloon ablating surface using a traditional navigation system. Additionally, although including additional navigation electrodes on the device may help locate the device, doing so poses new challenges for catheter design, manufacture, and steering, to name a few.

SUMMARY

The method and system disclosed herein allows for determination of a location of a treatment element relative to an anatomical feature and for estimation of contact between the treatment element and the anatomical feature in the context of a navigation system. In one embodiment, a system for determining a location of a medical device relative to an anatomical feature includes: a medical device including: an elongate body having a distal portion, a proximal portion, and a longitudinal axis; at least one treatment element coupled to the elongate body distal portion, the at least one treatment element having a surface geometry; and at least one navigation electrode coupled to the elongate body distal portion. The system also includes a navigation system in communication with the at least one navigation electrode, the navigation system including a processing unit having processing circuitry configured to: determine a first surface of the anatomical feature; determine a spatial location of each of the at least one navigation electrode; calculate the surface geometry of the at least one treatment element; define a plurality of points on the surface geometry of the at least one treatment element; for each of the plurality of points on the surface geometry of the at least one treatment element, define a point on the first surface of the anatomical feature that is closest to a corresponding point of the plurality of points on the surface geometry of the at least one treatment element; and for each defined point on the first surface of the anatomical feature, estimate a likelihood of contact between the defined point on the first surface of the anatomical feature and a corresponding point of the plurality of points on the surface geometry of the at least one treatment element.

In one embodiment, the medical device includes a first navigation electrode and a second navigation electrode.

In one embodiment, the first navigation electrode is distal to the at least one treatment element and the second navigation electrode is proximal to the at least one treatment element.

In one embodiment, the at least one treatment element is an expandable treatment element.

In one embodiment, the expandable treatment element is a substantially spherical balloon, the processing circuitry being configured to calculate the surface geometry of the balloon according to the equation:
Sb=f1(p1,p2,R,θ,φ)  (1)
where p1is a location of the first navigation electrode and p2is a location of the second navigation electrode.

In one embodiment, the expandable treatment element is a substantially cylindrical balloon, the processing circuitry being configured to calculate the surface geometry of the balloon according to the equation:
Sc=f2(p1,p2,R,θ,z)  (2)
where p1is a location of the first navigation electrode and p2is a location of the second navigation electrode.

In one embodiment, the at least one treatment element is an expandable array of electrodes, the processing circuitry being configured to calculate the surface geometry of the expandable array of electrodes according to the equation:
Sx=f3(p1,p2,xn,yn,zn)  (3)
where p1is a location of the first navigation electrode, p2is a location of the second navigation electrode, and n is a value sufficient to represent the surface geometry of the expandable array of electrodes.

In one embodiment, the at least one treatment element is a plurality of treatment elements located over a linear distance, the processing circuitry being configured to calculate the surface geometry of the plurality of treatment elements located over a linear distance according to the equation:
Sl=f3(p1,p2,g1(p1,p2),g2(p1,p2),g3(p1,p2))   (4)
where p1is a location of the first navigation electrode and p2is a location of the second navigation electrode.

In one embodiment, the processing circuitry is further configured to store an anatomical image of an area including the anatomical feature.

In one embodiment, the processing circuitry is configured to determine the first surface of the anatomical feature based on the anatomical image.

In one embodiment, the processing circuitry is further configured to determine a second surface of the anatomical feature, the second surface being opposite the first surface, the processing circuitry being configured to determine the first surface based on the second surface.

In one embodiment, the processing circuitry is configured to determine the first surface by transforming the second surface according to the equation:
[S1]=[M][S2]  (5)
where M is a transform.

In one embodiment, the processing circuitry is configured to estimate the likelihood of contact by assigning a value to each defined point on the first surface of the anatomical feature, the value being one of highly probable contact, likely contact, and no contact.

In one embodiment, the processing circuitry is configured to: assign a value of highly probable contact to a defined point on the first surface of the anatomical feature when a distance between the defined point on the first surface of the anatomical feature and the nearest point of the plurality of points on the surface geometry of the at least one treatment element is less than a first predetermined distance; and assign a value of likely contact to a defined point on the first surface of the anatomical feature when a distance between the defined point on the first surface of the anatomical feature and the nearest point of the plurality of points on the surface geometry of the at least one treatment element is between the first predetermined distance and a second predetermined distance, the first predetermined distance being less than the second predetermined distance.

In one embodiment, the first predetermined distance is 0.5 mm and the second predetermined distance is 1.0 mm.

In one embodiment, the processing circuitry is configured to estimate the likelihood of contact by assigning a value on a continuous scale to each defined point on the first surface of the anatomical feature, the value being one of: a minimum value indicating no contact; a maximum value indicating definite contact; and an intermediate value between the minimum value and the maximum value along the continuous scale, the intermediate value indicating possible contact with a varying degree of certainty.

In one embodiment, a system for determining a location of a medical device relative to an anatomical feature includes: a medical device including: an elongate body having a distal portion, a proximal portion, and a longitudinal axis; at least one treatment element coupled to the elongate body distal portion, the at least one treatment element having a surface geometry; and a first navigation electrode coupled to the elongate body distal portion distal to the at least one treatment element and a second navigation electrode coupled to the elongate body distal portion proximal to the at least one treatment element. The system also includes a navigation system in communication with the at least one navigation electrode, the navigation system being configured to store an anatomical image of an area including the anatomical feature, the navigation system including a processing unit having processing circuitry with a memory and a processor, the memory in communication with the processor and having instructions that, when executed by the processor, configure the processor to: determine a first surface of the anatomical feature and a second surface of the anatomical feature that is opposite the first surface, the processor being configured to determine the first surface based on one of: the anatomical image; and transformation of the second surface; determine a spatial location of each of the at least one navigation electrode; calculate the surface geometry of the at least one treatment element; define a plurality of points on the surface geometry of the at least one treatment element; for each of the plurality of points on the surface geometry of the at least one treatment element, define a point on the first surface of the anatomical feature that is closest to a corresponding point of the plurality of points on the surface geometry of the at least one treatment element; and for each defined point on the first surface of the anatomical feature, estimate a likelihood of contact between the defined point on the first surface of the anatomical feature and a corresponding point of the plurality of points on the surface geometry of the at least one treatment element, the estimation being one of: a minimum value indicating no contact; a maximum value indicating definite contact; and an intermediate value between the minimum value and the maximum value along a continuous scale, the intermediate value indicating possible contact with a varying degree of certainty, with the degree of certainty being less when the intermediate value is closer to the minimum value than when the intermediate value is closer to the maximum value.

In one embodiment, a method for determining a location of a medical device relative to an anatomical feature includes: providing an anatomical image of an area including the anatomical feature; providing a medical device, the medical device including at least one treatment element and at least one navigation electrode, the at least one treatment element having a surface geometry and each of the at least one navigation electrode being at a known location relative to the surface geometry; determining a surface of the anatomical feature based at least in part on the anatomical image; determining a spatial location of each of the at least one navigation electrode relative to the surface of the anatomical feature; calculating the surface geometry of the at least one treatment element; defining a plurality of points on the surface geometry of the at least one treatment element; for each of the plurality of points on the surface geometry of the at least one treatment element, defining a point on the first surface of the anatomical feature that is closest to a corresponding point of the plurality of points on the surface geometry of the at least one treatment element; and for each defined point on the surface of the anatomical feature, estimating a likelihood of contact between the defined point on the first surface of the anatomical feature and a corresponding point of the plurality of points on the surface geometry of the at least one treatment element.

In one embodiment, estimating the likelihood of contact includes assigning a value to each defined point on the first surface of the anatomical feature, the value being one of: highly probable contact; likely contact; and no contact.

In one embodiment, assigning a value to each defined point on the first surface includes: assigning the value of highly probable contact to a defined point on the first surface of the anatomical feature when a distance between the defined point on the first surface of the anatomical feature and the nearest point of the plurality of points on the surface geometry of the at least one treatment element is less than a first predetermined distance; and assigning a value of likely contact to a defined point on the first surface of the anatomical feature when a distance between the defined point on the first surface of the anatomical feature and the nearest point of the plurality of points on the surface geometry of the at least one treatment element is between the first predetermined distance and a second predetermined distance, the first predetermined distance being less than the second predetermined distance.

In one embodiment, the method further includes: providing a database containing geometrical information about the surface geometry of the at least one treatment element; and parameterizing the surface geometry of the at least one treatment element based on the geometrical information.

DETAILED DESCRIPTION

The method and system disclosed herein allows for determination of a location of a treatment element relative to an anatomical feature and for estimation of contact between the treatment element and the anatomical feature in the context of a navigation system. Generally speaking, the system may include a medical device including at least one treatment element and at least one navigation electrode and a navigation system in communication with the one or more navigation electrodes, the navigation system including a processing unit. The processing unit may be programmed to determine a plurality of points that define a surface geometry of the at least one treatment element, calculate a distance between each of the points and a closest point on the anatomical feature, and estimate the likelihood of contact between the points. The method may include determining a plurality of points that define a surface geometry of an at least one treatment element of a medical device, calculating a distance between each of the points and a closest point on the anatomical feature, and estimating the likelihood of contact between the points.

Before describing in detail exemplary embodiments that are in accordance with the disclosure, it is noted that components have been represented where appropriate by conventional symbols in drawings, showing only those specific details that are pertinent to understanding the embodiments of the disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

Referring now to the drawing figures in which like reference designations refer to like elements, an embodiment of a medical system constructed in accordance with the principles of the present invention is shown inFIGS. 1A and 1B, generally designated as “10.” The system10generally includes a medical device12that may be coupled to a control unit14or operating console and a navigation system16in communication with the device12and the control unit14. The medical device12may generally include one or more diagnostic or treatment elements for energetic, therapeutic, and/or investigatory interaction between the medical device12and a treatment site or region. The diagnostic or treatment region(s) may deliver, for example, cryogenic therapy, thermal energy, radiofrequency energy, ultrasound energy, laser energy, or other energetic transfer with a tissue area in proximity to the treatment region(s), including cardiac tissue.

The medical device12may be a treatment and/or mapping device. Broadly, the device12may be any catheter, medical device, or insertable element requiring visualization on a navigation system. The medical device12may include an elongate body18passable through a patient's vasculature and/or proximate to a tissue region for diagnosis or treatment. For example, the device12may be a catheter that is deliverable to the tissue region via a sheath or intravascular introducer (not shown). The elongate body18may define a proximal portion20, a distal portion22, and a longitudinal axis24, and may further include one or more lumens disposed within the elongate body18thereby providing mechanical, electrical, and/or fluid communication between the elongate body proximal portion20and the elongate body distal portion28.

The medical device12may further include one or more treatment elements30at, coupled to, or on the elongate body distal portion22. In the non-limiting embodiment shown inFIGS. 1A and 1B, the device may include a treatment element30that is expandable, such as one or more balloons. However, it will be understood that the device may include one or more treatment elements30that are not expandable. For example, the device12may be a focal catheter that includes one or more electrodes on the distal portion22, and each electrode may be considered to be a treatment element30. Even if the device12includes an expandable treatment element, the device12may also include one or more treatment electrodes on the expandable treatment element, the catheter body, and/or other suitable locations, even though treatment electrodes are not shown in the figures. Further, the medical device12may have a configuration that provides complex geometry to the treatment element(s). For example, instead of an expandable balloon, the medical device12may include one or more carrier arms bearing the treatment element(s).

The expandable treatment element30of the system shown inFIG. 1Bmay be coupled to a portion of the elongate body distal portion22. The device may optionally include a shaft that is slidably disposed within the elongate body18and at least a portion of the shaft may be located within the expandable treatment element30. The shaft may further include or define a distal tip34that may protrude beyond the distal end of the expandable treatment element30. The expandable treatment element30may further include one or more material layers providing for puncture resistance, radiopacity, or the like. If the device12is used to delivery cryotherapy (or if used with another energy modality that requires fluid to be delivered to the inner chamber of the treatment element30), the device may also include one or more fluid injection elements. A device having a non-expandable treatment element may also include one or more fluid injection elements within the elongate body18proximate the one or more treatment elements30(for example, treatment electrode(s)). Further, if the device12is used or mapping in addition to or instead of for the delivery of treatment, the device12may include one or more mapping electrodes. Although the term “treatment element” is used herein, it will be understood that a mapping element or mapping electrodes could be used instead.

As is discussed in more detail below, the device12may also include one or more navigation electrodes38that are used by the navigation system16to visualize the device12on a control unit display and/or a navigation system display. For example, the device12shown inFIGS. 1A and 1Bmay include a first navigation electrode38adistal to the expandable portion of the treatment element30and a second navigation electrode38bproximal to the expandable portion of the treatment element30. Although the navigation electrodes38a,38bare shown as being coupled to the portion of the treatment element30that is coupled to the elongate body and/or shaft of the device, the navigation electrodes38a,38bcould alternatively be located distal and proximal to all portions of the treatment element. Additionally, the device may include more or fewer navigation electrodes38than are shown inFIGS. 1A and 1B. Regardless of the number, configuration, or location of the navigation electrode(s)38, each navigation electrode38is a known distance from, or location relative to, the treatment element(s)30.

Each treatment electrode (if included) and navigation electrode38may be electrically conductive segments for conveying an electrical signal, magnetic signal, current, or voltage to a designated tissue region and/or for measuring, recording, receiving, receiving, assessing, or otherwise using one or more electrical properties or characteristics of surrounding tissue or other electrodes. The electrodes may be configured in a myriad of different geometric configurations or controllably deployable shapes, and may also vary in number to suit a particular application, targeted tissue structure or physiological feature.

If the treatment element(s)30includes treatment electrodes, each treatment electrode may be electrically coupled to an output portion of a power source42, such as a radiofrequency energy generator or other type of energy generator, and may be in electrical communication with the control unit14. Each navigation electrode38may also be in communication with the navigation system16and the control unit14, and may be configured to receive magnetic or electric signals from the navigation system and transmit signals to the control unit14and/or navigation system16in a wired and/or wireless connection.

The system10may include one or more sensors to monitor the operating parameters throughout the system, including for example, pressure, temperature, flow rates, volume, power delivery, impedance, or the like in the control unit14and/or the medical device12, in addition to monitoring, recording or otherwise conveying measurements or conditions within the medical device12or the ambient environment at the distal portion of the medical device12. The sensor(s) may be in communication with the control unit14for initiating or triggering one or more alerts or therapeutic delivery modifications during operation of the medical device12. One or more valves, controllers, or the like may be in communication with the sensor(s) to provide for the controlled dispersion or circulation of fluid through the lumens/fluid paths of the medical device12. Such valves, controllers, or the like may be located in a portion of the medical device12and/or in the control unit14.

The medical device12may include a handle44coupled to the elongate body proximal portion20. The handle44may include circuitry for identification and/or use in controlling of the medical device12or another component of the system. Additionally, the handle44may also include connectors46that are mateable to the control unit14to establish communication between the medical device12and one or more components or portions of the control unit14. The handle44may also include one or more actuation or control features that allow a user to control, deflect, steer, or otherwise manipulate a distal portion of the medical device12from the proximal portion of the medical device12. For example, the handle44may include one or more components such as a lever or knob46for manipulating the elongate body18and/or additional components of the medical device12.

As used herein, the term “control unit14” for simplicity may include any system components that are not part of the medical device12itself, other than components of the navigation system, regardless of whether the component is physically located within or external to the control unit14. Further, the navigation system16may be a standalone system in communication with the control unit14or may be contained within or integrated with the control unit14, even though it is shown as being physically separated from the control unit inFIGS. 1A and 1B. The control unit14may include one or more components for the delivery of one or more energy modalities for which the system is used. For example, if the system10is used to deliver cryotherapy, the control unit14may include a supply48of a fluid such as a coolant, cryogenic refrigerant, or the like, an exhaust or scavenging system for recovering or venting expended fluid for re-use or disposal, as well as various control mechanisms. In addition to providing an exhaust function for the fluid or coolant supply48, the control unit14may also include pumps, valves, controllers or the like to recover and/or re-circulate fluid delivered to the handle44, the elongate body18, and/or the fluid pathways of the medical device12. Further, a vacuum pump50in the control unit14may create a low-pressure environment in one or more conduits within the medical device12so that fluid is drawn into the conduit(s)/lumen(s) of the elongate body18, away from the distal portion22and towards the proximal portion20of the elongate body18. Additionally or alternatively, the control14unit may include a radiofrequency generator or power source42as a treatment or diagnostic mechanism in communication with treatment electrode(s) of the medical device12. The radiofrequency generator42may have a plurality of output channels, with each channel coupled to an individual treatment electrode. The radiofrequency generator42may be operable in one or more modes of operation.

The control unit14may include one or more controllers, processors, and/or software modules52containing circuitry configured to execute instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein. For example, the processor(s)52may be configured, programmed, or programmable to perform the calculations and make the determinations discussed in greater detail below to identify a target location for a medical device relative to an anatomical feature, even if that device has complex geometry that has traditionally made the process challenging. Further, the control unit14may include one or more user input devices, controllers, and displays54for collecting and conveying information from and to the user.

The navigation system16may be any commercially available navigation system suitable for use with the control unit14, device12, and type of procedure. As a non-limiting example, the navigation system16may include a plurality of surface electrodes56, a reference electrode (not shown), and a processing unit58that collects and processes signals from the navigation electrodes38, and a display that displays to the user the location of the device12within the patient's body57and/or relative to the target anatomical feature (for example, a pulmonary vein ostium), and recommended landing zones for the device12. The processing unit58may include processing circuitry including a memory and a processor, the memory in communication with the processor and having instructions that, when executed by the processor, configure the processor to perform the calculations and determinations discussed herein. Additionally or alternatively, this information may be displayed on the display64of the control unit14. The navigation system16may also include an energy generator (not shown) for delivering energy to the plurality of surface electrodes56. Alternatively, the navigation system may be in communication with the control unit power source42. It will be understood that the calculations discussed herein may additionally or alternatively be performed by one or more processors64within the control unit14.

As shown inFIGS. 1A and 1B, the surface electrodes56may be applied to the patient's skin and may deliver relatively low-frequency radiofrequency energy through the patient toward the procedure site, current device location, or the target anatomical feature. The navigation electrode(s)38on the device12may each record a voltage and impedance from this energy and transmit data to the processing unit58, which may then determine a position of the electrode(s)38, and therefore the device12, within the patient. The processing unit58may perform this calculation many times during a procedure, frequently updating the registered location and displaying such to the user so the user can visualize the location of the device relative to the target anatomical feature in real time. However, it will be understood that the navigation electrode(s)38may be configured to be used with navigation systems other than impedance-based systems, such as navigation systems that are magnetic field based, hybrid impedance/magnetic field based, ultrasound field based, and/or radiation based.

The navigation system16may be configured to receive, store, manipulate, display, or otherwise use a digital image of the anatomical structure including the target treatment area. The image may be obtained using an imaging system68, such as a computed tomography (CT) system, a magnetic resonance imaging (MRI) system, or other system suitable for creating images of locations within a patient's body. For example, the imaging system68may create images in Digital Imaging and Communications in Medicine (DICOM) format. The imaging system68may be in communication with and digitally transmit images to the navigation system16and/or the control unit14for further processing. Additionally or alternatively, images recorded by the imaging system68may be recorded and transferred to the navigation system12and/or the control unit14by a user.

Now referring toFIG. 2, a schematic representation of a method for locating a medical device relative to a target tissue structure is shown. The system10may identify one or more target anatomical features, such as pulmonary vein(s), prior to or during the procedure. A target pulmonary vein ostium, for example, may be manually defined by the user or automatically or semi-automatically defined by the control unit14or navigation system16using an algorithm executed by the processor(s)64or processing unit58. When executed, the algorithm may be used to estimate a location of the device12relative to the anatomical structure and quality of contact between target tissue and the treatment element30.

The process performed by the processing unit58of the navigation system16is now discussed in more detail. However, if the algorithm for the initial identification of the target anatomical feature is executed by the processor(s)64of the control unit14, this information will be transmitted from the control unit14to the navigation system16, which may then perform the calculations/execute further algorithm(s) for determining the optimal device position for the procedure.

As an initial step, a digital anatomical image (for example, a DICOM file) may be transmitted to, uploaded to, or otherwise made accessible to the navigation system16(Step100). The image may be of a particular structure that includes the target anatomical feature. In the next step, the surface geometry may be determined. As a non-limiting example, the structure that will be referred to in describing the method may be a heart and the target anatomical feature may be a left atrial wall. However, it will be understood that this method may be used for other structures and anatomical features as well. In Step102, the processing unit58may determine endocardial first surface Sendoand its geometry from the image. Additionally or alternatively, the processing unit58may infer the endocardial surface Sendofrom an epicardial second surface Sepiimage using a suitable transform M according to the following equation:
[Sendo]=[M][Sepi]  (1)
Put another way, the processing unit58may apply a transform M to the epicardial surface Sepiin the image to estimate the endocardial surface Sendo. The endocardial surface may then be displayed on the navigation system display60and/or the control unit display54.

The medical device12may then be navigated through the patient's body and into the heart. The navigation system16may detect the navigation electrode(s)38and the processing unit58may determine the spatial location of each navigation electrode38(Step104) within the heart using the navigation system16. For example, the location may be defined with Cartesian coordinates (e.g., p1(x1, y1, z1), p2(x2, y2, z2), etc.); however, it will be understood that any other system of defining a location may additionally or alternatively be used.

In the next step, the processing unit58may calculate the surface geometry of the medical device treatment element(s)30relative to navigation electrode data38(Step106). If the treatment element30is a balloon, the surface geometry may be the geometry of the outer surface of the balloon. If the treatment element(s)30are arranged in a linear pattern (for example, if the device is a focal catheter or a multi-electrode linear or non-linear device), the surface geometry may be the geometry of the length of the device body18over which the treatment element(s)30are located. The treatment element(s)30may be arranged in a more complex configuration, such as may be the case for devices having an expandable electrode array31as shown inFIG. 1A. In this case, the surface geometry may be a geometry of an imaginary surface that includes all the treatment element(s)30. The processing unit58may access a database containing geometrical information about the surface geometry of the particular treatment element30used on the device12relevant to the navigation electrode(s)38. The database may be stored within the navigation system16, the control unit14, and/or in a component external to the navigation system16and/or the control unit14. This data may be used to parameterize the surface geometry of the treatment element(s). For example, the processing unit58may parameterize a substantially spherical treatment element (Sb)30, such as a balloon, as a function of geometrical variables such as R(θ, φ), θ, φ to map the surface extent of the treatment element30relative to the navigation electrode(s)38:
Sb=f1(p1,p2,R,θ,φ)  (2)
Likewise, if the treatment element30has a geometry that may conveniently be expressed in cylindrical coordinates (for example, an elongated, substantially cylindrical balloon), the processing unit58may use the geometrical variables (R, θ, z), where z may be expressed relative to the navigation electrode(s)38(for example, p1and p2) rather than the absolute coordinate system of Sendo:
Sc=f2(p1,p2,R,θ,z)  (3)
As a further example, the processing unit58may use a combination of cubic splines or other functions for a device12with one or more treatment element(s)30over a region with linear geometry (for example, a focal catheter), and the number of navigation electrode(s)38on the device12should be sufficient to uniquely reflect the location of the linear segment:
Sl=f3(p1,p2,g1(p1,p2),g2(p1,p2),g3(p1,p2))  (4)
where g is a predetermined curve fit for the structure. The values for g may be determined based on the device construction and/or shape the device takes based on the location of the navigation electrodes. The variable g is representative of any number of geometric points along the cubic splines. Therefore, g1, g2, and g3are representative of the number of navigation electrodes38used on the device12. Additionally, variables f1, f2, and f3indicate functions of the variables within the parentheses. For example, f1is a first function, f2is a second function, and f3is a third function.

In other cases, the geometry of the device12may be expressed entirely as a set of points (e.g., (xn, yn, zn) relative to the navigation electrode(s)38where the index n can be chosen to be any arbitrary value sufficient to adequately represent the catheter surface:
Sx=f3(p1,p2,xn,yn,zn)  (5)
As a non-limiting example, this calculation may be used for devices in which the treatment element is an expandable array31of electrodes, a balloon with non-spherical or non-cylindrical geometry, and for other devices having a non-uniform treatment element or array31of treatment elements.

The processing unit58may now analyze each point on the surface of the treatment element(s)30and/or surface geometry of an area including treatment element(s) (for example, in the case of a device having an expandable electrode array31or a focal catheter having a length over which treatment element(s) are located) to determine a distance to the nearest point on the endocardial surface Sendo(Step108). At each point, a zone of influence may be used to estimate the likelihood of contact between the treatment element(s)30and the endocardial surface. For example, the zone of influence may be chosen such that a distance of less than a first predetermined amount (for example, 0.5 mm) between the treatment element(s)30and its nearest point on the endocardial surface Sendowould be labeled as “highly probable contact” and a second predetermined amount (for example, between 0.5 mm and 1.0 mm) would be labeled as “likely contact.” Other points not labeled as “highly probable contact” or “likely contact” may be labeled as “no contact” for simplicity, even if there is a small likelihood of contact. The zones of influence of each contact indicator may be displayed as isolines77,79, and81in the endocardial surface map72.

Alternatively, contact assessment could be based on a continuous scale instead of the ordinal scale disclosed immediately above. As a non-limiting example, the scale may begin at a minimum value (for example, 0) indicating no contact, and end at a maximum value (for example, 100) indicating definite contact. The intermediate values between the minimum and maximum values may represent all levels of confidence between a determination of “no contact” and a determination of “definite contact.” The intermediate values and associated indications of contact may also be based on distance between a point on the treatment element(s)30and its nearest point on the endocardial surface Sendo, which each value being displayed as an isoline77,79, and81in the endocardial surface map72. Intermediate values may indicate possible contact with a varying degree of certainty. For example, a value indicating possible contact with a high degree of certainty (that is, closer to the maximum value of the continuous scale) may be interpreted as equivalent to an ordinal value of “highly likely contact.” Although the values on the continuous scale may be presented to the user in the same way as the values in the ordinal scale, but using the continuous scale may enable the system to communicate to the user a larger number of contact indicators. Nuances in the areas represented by the contact indicators may help the user better understand the overall state of contact between the endocardial surface Sendoand the treatment element(s)30.

Further, the zone of influence may be adjusted for various aspects of the navigation system16. For example, the zone of influence may be adjusted to compensate for the accuracy of the navigation positioning system itself, if the navigation positioning system accuracy were to be less than ideal.

The processing unit58may then augment the endocardial surface Sendoand display an adjusted endocardial surface map72on the navigation system display60and/or control unit display54to graphically distinguish the different points of treatment element-to-tissue contact. For example, physical points of contact and estimated contact quality (zone of influence) as described above may be displayed and graphically distinguished using markers, for example, different colors, shading, symbols, or the like. Points identified as being within a zone of highly probable contact may be identified on the endocardial surface map72with “high probability” markers (for example, by color, shading, symbols, or the like) and points identified as being within a zone of likely contact may be identified on the endocardial surface map72with “likely” markers (Step110).

Exemplary endocardial surface maps72are shown inFIGS. 3 and 4. The endocardial surface Sendomay be shown in a three-dimensional image. In the images shown inFIGS. 3 and 4, for example, the treatment element30may be shown in a first color. Areas of the treatment element30that are not in contact or are not likely to be in contact (identified as “no contact”)76and the corresponding isoline77may be also be shown in the first color. In other words, the only areas of the treatment element30that are shown in a different color, or are otherwise graphically distinguished, from the treatment element30are the areas of the treatment element identified as being areas of likely contact78and the corresponding isoline79and areas of highly probable contact80and the corresponding isoline81. For example, areas of likely contact78may be shown in a second color and areas of highly probable contact80may be shown in a third color. However, it will be understood that any scheme for differentiating these points may be used.

The endocardial surface map72may be continuously refreshed as the device12is moved relative to the endocardial surface Sendoand/or the image may be captured for display and storage.FIG. 3shows an endocardial map72in which initial contact is detected between the treatment element(s)30(here, a spherical or approximately spherical treatment element such as a spherical or approximately spherical balloon) and the endocardial surface Sendois indicated. InFIG. 4, contact between the treatment element(s)30and the endocardial surface Sendomay increase or improve as the device12is maneuvered relative to the target anatomical feature. For example,FIG. 4shows an increased size of the area identified as highly probable contact80and the corresponding isoline81, meaning contact is improving or has improved.

The processing unit58may infer the zone of contact from the position of the device within the heart based on the location(s) of the navigation electrode(s)38and the geometry of the treatment element30relative to the navigation electrode(s)38and the endocardial surface Sendo. This method may allow devices with arbitrary geometry to be displayed relative to the endocardial surface Sendousing a minimal amount of navigation electrode(s)38. Since the processing unit58defines the treatment element geometry entirely as a set of points (xn, yn, zn), these points may be used as reference points to determine a location of the device, thereby reducing the number of required navigation electrode(s)58. Additionally, the calculated contact regions between the treatment element(s)30and the tissue may be qualified with a zone of influence indicator, thus providing the user with a better representation of treatment element-to-tissue contact.

As will be appreciated by one of skill in the art, certain concepts described herein may be embodied as a method, data processing system, and/or computer program product. Accordingly, these concepts described herein may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the disclosure may take the form of a computer program product on a tangible computer usable storage medium having computer program code embodied in the medium that can be executed by a computer. Any suitable tangible computer readable medium may be utilized including hard disks, CD-ROMs, electronic storage devices, optical storage devices, or magnetic storage devices.