User interface with 3D environment for configuring stimulation therapy

The disclosure describes a method and system that allows a user to configure electrical stimulation therapy by defining a three-dimensional (3D) stimulation field. After a stimulation lead is implanted in a patient, a clinician manipulates the 3D stimulation field in a 3D environment to encompass desired anatomical regions of the patient. In this manner, the clinician determines which anatomical regions to stimulate, and the system generates the necessary stimulation parameters. In some cases, a lead icon representing the implanted lead is displayed to show the clinician where the lead is relative to the 3D anatomical regions of the patient.

TECHNICAL FIELD

The invention relates to medical devices and, more particularly, to user interfaces for configuring electrical stimulation therapy.

BACKGROUND

Implantable electrical stimulators may be used to deliver electrical stimulation therapy to patients to treat a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. In general, an implantable stimulator delivers neurostimulation therapy in the form of electrical pulses. An implantable stimulator may deliver neurostimulation therapy via one or more leads that include electrodes located proximate to target tissues of the brain, the spinal cord, pelvic nerves, peripheral nerves, or the stomach of a patient. Hence, stimulation may be used in different therapeutic applications, such as deep brain stimulation (DBS), spinal cord stimulation (SCS), pelvic stimulation, gastric stimulation, or peripheral nerve stimulation. Stimulation also may be used for muscle stimulation, e.g., functional electrical stimulation (FES) to promote muscle movement or prevent atrophy.

In general, a clinician selects values for a number of programmable parameters in order to define the electrical stimulation therapy to be delivered by the implantable stimulator to a patient. For example, the clinician ordinarily selects a combination of electrodes carried by one or more implantable leads, and assigns polarities to the selected electrodes. In addition, the clinician selects an amplitude, which may be a current or voltage amplitude, a pulse width and a pulse rate for stimulation pulses to be delivered to the patient. A group of parameters, including electrode combination, electrode polarity, amplitude, pulse width and pulse rate, may be referred to as a program in the sense that they drive the neurostimulation therapy to be delivered to the patient. In some applications, an implantable stimulator may deliver stimulation therapy according to multiple programs either simultaneously or on a time-interleaved, overlapping or non-overlapping, basis.

The process of selecting electrode combinations and other parameters can be time consuming, and may require a great deal of trial and error before a therapeutic program is discovered. The “best” program may be a program that best balances greater clinical efficacy and minimal side effects experienced by the patient. In addition, some programs may consume less power during therapy. The clinician typically needs to test a large number of possible electrode combinations within the electrode set implanted in the patient, in order to identify an optimal combination of electrodes and associated polarities. As mentioned previously, an electrode combination is a selected subset of one or more electrodes located on one or more implantable leads coupled to an implantable neurostimulator. As a portion of the overall parameter selection process, the process of selecting electrodes and the polarities of the electrodes can be particularly time-consuming and tedious.

The clinician may test electrode combinations by manually specifying combinations based on intuition or some idiosyncratic methodology. The clinician may then record notes on the efficacy and side effects of each combination after delivery of stimulation via that combination. In some cases, efficacy can be observed immediately within the clinic. For example, spinal cord stimulation may produce parasthesia and side effects that can be observed by the clinician based on patient feedback. In other cases, side effects and efficacy may not be apparent until a program has been applied for an extended period of time, as is sometimes the case in deep brain stimulation. Upon receipt of patient feedback and/or observation of symptoms by the clinician, the clinician is able to compare and select from the tested programs.

In order to improve the efficacy of neurostimulation therapy, electrical stimulators have grown in capability and complexity. Modern neurostimulators tend to have larger numbers of electrode combinations, larger parameter ranges, and the ability to simultaneously deliver multiple therapy configurations by interleaving stimulation pulses in time. Although these factors increase the clinician's ability to adjust therapy for a particular patient or disease state, the burden involved in optimizing the device parameters has similarly increased. Unfortunately, fixed reimbursement schedules and scarce clinic time present challenges to effective programming of neurostimulator therapy.

Existing lead sets include axial leads carrying ring electrodes disposed at different axial positions, and so-called “paddle” leads carrying planar arrays of electrodes. Selection of electrode combinations within an axial lead, a paddle lead, or among two or more different leads presents a challenge to the clinician. The emergence of more complex lead array geometries presents still further challenges. The design of the user interface used to program the implantable neurostimulator, in the form of either a clinician programmer or patient programmer, has a great impact on the ability to efficiently define and select efficacious stimulation programs.

SUMMARY

The disclosure is directed to a method and system that allows a user to configure electrical stimulation therapy by defining a stimulation field in three-dimensions (3D) in a 3D environment. The stimulation field may be delivered via one or more leads having a complex electrode array geometry. The techniques may be applied to a programming interface associated with a clinician programmer, a patient programmer, or both.

After a stimulation lead is implanted in a patient, a clinician manipulates a 3D stimulation field presented in a 3D environment of a device to encompass desired anatomical regions. In this manner, the clinician determines which anatomical regions to stimulate, and the system is able to automatically generate the necessary stimulation parameters to approximate the defined stimulation field within the patient.

To manipulate a stimulation field delivered by a complex lead array geometry, a user interface may permit a user to view one or more leads and stimulation fields produced by the leads from different perspectives. In addition, the lead may be displayed with a representation of the anatomical structure in which the lead is implanted. For example, the user interface may provide one or more perspectives of a lead with a cross-sectional perspectives of the anatomical structure. In a DBS application, for example, the perspectives may include a sagittal view, a coronal view and an axial view of the lead implanted within the brain.

A complex electrode array geometry generally refers to an arrangement of stimulation electrodes at multiple non-planar or non-coaxial positions, in contrast to simple electrode array geometries in which the electrodes share a common plane or a common axis. An example of a simple electrode array geometry is an array of ring electrodes distributed at different axial positions along the length of a lead. Another example of a simple electrode array geometry is a planar array of electrodes on a paddle lead.

An example of a complex electrode array geometry, in accordance with this disclosure, is an array of electrodes positioned at different axial positions along the length of a lead, as well as at different angular positions about the periphery, e.g., circumference, of the lead. In some embodiments, the electrodes in the complex array geometry may appear similar to non-contiguous, arc-like segments of a conventional ring electrode. A lead with a complex electrode array geometry may include multiple “rings” of such electrode segments. Each ring is disposed at a different axial position. Each electrode segment within a given ring is disposed at a different angular position. The lead may be cylindrical or have a circular cross-section of varying diameter. Another example of a complex electrode array geometry is an array of electrodes positioned on multiple planes or faces of a lead. As an illustration, arrays of electrodes may be positioned on opposite planes of a paddle lead or multiple faces of a lead having a polygonal cross-section.

An electrode combination is a selected subset of one or more electrodes located on one or more implantable leads coupled to an implantable stimulator. The electrode combination also refers to the polarities of the electrodes in the selected subset. The electrode combination, electrode polarities, amplitude, pulse width and pulse rate together define a program for delivery of electrical stimulation therapy by an implantable stimulator via an implantable lead or leads.

In some cases, a lead icon representing the implanted lead is displayed to show the clinician where the lead is relative to one or more anatomical regions of the patient. Electrodes mounted at different axial and angular positions of an implanted lead may allow the clinician to provide a more directional stimulation field to more effectively stimulate a target nerve site, reduce side affects, or compensate for inaccurate lead placement.

The task of effectively configuring electrical stimulation therapy increases substantially as geometries and capabilities of stimulation leads become more complex. In particular, leads with complex electrode array geometries present the difficult task of orienting the position of lead electrodes to anatomical structures of the patient in a manner intuitive to the clinician. Allowing the clinician to partially or completely disregard the electrode locations and focus on manipulating the stimulation field to stimulate the desired anatomical structures may decrease time and confusion in configuring the electrical stimulation and increase therapy efficacy.

The disclosure describes multiple embodiments of a user interface designed to allow the clinician to effectively program delivery of stimulation from leads having complex electrode array geometries. The user interface may use a 3D environment to display the anatomical region of the patient and the stimulation field which may allow a clinician to more effectively visualize and efficiently program the stimulation from complex lead geometries than would be possible using multiple two-dimensional representations.

The techniques described herein may be used during a test or evaluation mode to select different electrode combinations in an effort to identify efficacious electrode combinations. Additionally, the techniques may be used to select different electrode combinations associated with different stimulation programs during an operational mode, either directly or by selection of programs including such electrode combinations. For example, the techniques and associated user interfaces may be implemented in a clinician programmer used by a clinician to program a stimulator, in a patient programmer used by a patient to program or control a stimulator, or in an external stimulator including both pulse generation and programming functionality.

In one embodiment, the disclosure provides a method that includes representing a three-dimensional (3D) anatomical region of a patient in a 3D environment, representing a 3D stimulation field within the 3D anatomical region, and receiving stimulation field input from a user defining the 3D stimulation field in the 3D environment. The method also includes generating electrical stimulation parameters in a programming device based upon the 3D stimulation field and a location of at least one electrode within patient.

In another embodiment, the disclosure provides a system that includes a user interface that provides a three-dimensional (3D) environment and a processor that represents a 3D stimulation field within a 3D anatomical region of a patient within the 3D environment, receives stimulation field input from a user via the user interface defining the 3D stimulation field within the 3D environment, and generates electrical stimulation parameters based upon the 3D stimulation field and a location of at least one electrode within patient.

In an additional embodiment, the disclosure provides a computer-readable medium that includes instructions that cause a processor to represent a three-dimensional (3D) anatomical region of a patient in a 3D environment, represent a 3D stimulation field within the 3D anatomical region, receive stimulation field input from a user defining the 3D stimulation field in the 3D environment, and generate electrical stimulation parameters in a programming device based upon the 3D stimulation field and a location of at least one electrode within patient.

In various embodiments, the disclosure may provide one or more advantages. The system may automatically generate the electrode combinations and stimulation parameters necessary to approximate the defined stimulation field in the patient. Thus, a clinician may define a stimulation field in three dimensions and adjust the stimulation field to reduce the time required to identify parameters for stimulation anatomical region of the patient relative to conventional trial and error techniques. The clinician may also be able to more effectively avoid producing side effects with the stimulation. In some embodiments, the clinician may visually define a more directional stimulation field to target anatomical regions for stimulation and avoid the lengthy and tedious task of manually selecting stimulation parameters to try and find the most effective parameters.

DETAILED DESCRIPTION

Electrical stimulation therapy may provide relief to a patient from many conditions. However, the stimulation therapy efficacy is contingent on a clinician correctly configuring, or programming, the stimulation parameters in a manner that provides therapy to the patient while minimizing side-effects produced from the stimulation. Due to physiological diversity, condition differences, and inaccuracies in stimulation lead placement, the parameters may vary greatly between patients. Therefore, the clinician must individually program stimulation parameters for each patient. This programming process continues throughout the therapy as patient needs change.

Implanting stimulation leads with complex electrode array geometries introduces more complex programming challenges for the clinician. Although leads with complex electrode array geometries provide greater flexibility in defining a stimulation field to provide therapy, the clinician must identify effective electrodes, electrode polarity, current and voltage amplitudes, pulse widths, and pulse frequencies of each electrode combination. Clinicians may prefer to focus on stimulating a particular anatomical structure or target tissue of the patient, which becomes difficult when facing potentially millions of programming options presented by a complex electrode array geometry.

A complex electrode array geometry generally refers to an arrangement of stimulation electrodes at multiple non-planar or non-coaxial positions, in contrast to simple electrode array geometries in which the electrodes share a common plane or a common axis. An example of a simple electrode array geometry is an array of ring electrodes distributed at different axial positions along the length of a lead. Another example of a simple electrode array geometry is a planar array of electrodes on a paddle lead.

An example of a complex electrode array geometry, in accordance with this disclosure, is an array of electrodes positioned at different axial positions along the length of a lead, as well as at different angular positions about the circumference of the lead. In some embodiments, the electrodes in the complex array geometry may appear similar to non-contiguous, arc-like segments of a conventional ring electrode. A lead with a complex electrode array geometry may include multiple rings of electrode segments. Each ring is disposed at a different axial position. Each electrode segment within a given ring is disposed at a different angular position. The lead may be cylindrical or have a circular cross-section of varying diameter.

Another example of a complex electrode array geometry is an array of electrodes positioned on multiple planes or faces of a lead. As an illustration, arrays of electrodes may be positioned on opposite planes of a paddle lead or multiple faces of a lead having a polygonal cross-section in a plane transverse to the longitudinal axis of the lead. As further examples, electrodes may be arranged at different axial and angular positions on leads defining spherical, hemispherical or generally rounded surfaces. Leads with complex electrode array geometries may have a defined shape or be at least partially conformable to an anatomical structure. In some embodiments, electrodes may be arc sections conforming to the overall lead geometry. In addition, the electrodes may also be recessed within the lead.

An electrode combination is a selected subset of one or more electrodes located on one or more implantable leads coupled to an implantable stimulator. The electrode combination also refers to the polarities of the electrode segments in the selected subset. The electrode combination, electrode polarities, amplitude, pulse width and pulse rate together define a program for delivery of electrical stimulation therapy by an implantable stimulator via an implantable lead or leads. By selecting particular electrode combinations, a physician can target particular anatomic structures. By selecting values for amplitude, pulse width and pulse rate, the physician can attempt to optimize the electrical therapy delivered to the patient via the selected electrode combination or combinations.

As stimulation is moved from one electrode to another electrode around the periphery, e.g., circumference, of a lead, the stimulation may affect entirely different anatomical structures. For this reason, providing the clinician with an interface that shows the electrodes in relation the anatomical regions of the patient may be beneficial to effective and efficient programming. Displaying the anatomy of the patient to the clinician may allow the clinician to focus on configuring a stimulation field such that it is applied to targeted tissue, instead of manually manipulating electrodes of a lead to conform to the anatomical structures of the patient. Once desired stimulation field is “marked” on an anatomical region of the patient, a system may automatically generate the required stimulation parameters needed to approximate the defined stimulation field requested by the clinician. The stimulator then applies the stimulation parameters to produce the field within the patient.

In accordance with this disclosure, a user interface facilitates electrical stimulation programming by allowing a clinician to define and manipulate a stimulation field within anatomical regions representing the anatomical structures of the patient using a “field view.” The stimulation field may be shown in conjunction with a representation of the implanted lead, e.g., a lead icon; and the field and lead representations may be shown in relation the anatomical structures.

The resulting user interface may provide a programming environment that promotes delivering therapy instead of programming individual stimulation parameters of each electrode. However, an electrode view that permits programming of individual parameters and electrodes may be provided on a selective basis.

The user interface may include two or more two dimensional (2D) views of anatomical regions of the patient, or a 3D representation of the anatomical regions. One or more stimulation fields are displayed on the anatomical regions, and the clinician may adjust or manipulate the stimulation fields to reach the target one or more anatomical regions.

The user interface may be applied to any type electrical stimulation lead. Even programming a lead with one electrode, or an array of electrodes in one plane (2D), may become less demanding of clinic resources and result in greater quality of patient therapy when compared to trial and error programming techniques that focus on manual selection of electrodes instead of the stimulation field that the electrodes produce.

To select electrode combinations within a complex lead array geometry, in accordance with this disclosure, a user interface permits a user to view electrodes from different perspectives relative to the lead. For example, the user interface may provide one or more axial perspectives of a lead and a cross-sectional perspective of the lead in a plane transverse to a longitudinal axis of the lead. For DBS applications, examples of multiple perspectives include views of coronal, sagittal and horizontal planes of the brain and the lead implanted within the brain.

As an alternative or in addition to defining and manipulating a stimulation field to program the electrical stimulation therapy, the user may program the stimulation therapy by selecting the appropriate structure of the anatomical region to stimulate. For example, the system may provide the user with an atlas, or reference anatomical region of a reference anatomy, that the user may use to select structures to stimulate. Alternatively, the system may provide the user with a morphed atlas that combines the reference anatomical region with a specific patient anatomical region. This morphed atlas may allow the user to view known structures while correlating the known structures to the specific patient anatomical region. The system may determine the stimulation parameters for stimulation based upon the selected structures from the morphed atlas. In this manner, programming the stimulation parameters may be more efficient for a clinician by reducing or eliminating the need to manually program the stimulation parameters.

In other embodiments, the system may show the user the tissue that will be affected by the electrical stimulation as defined by the user. The system may create a stimulation template set defining stimulation parameters that best matches the stimulation field defined by the user. The template set may be shown to the user in relation to the desired stimulation field to illustrate the tissue that will be stimulated by the system. The stimulation template set may be created from many stimulation templates stored within the system and used to simplify the process of generating stimulation parameters that fit the desired stimulation field.

Alternatively, the system may illustrate an electrical field over the anatomical region to illustrate the estimated tissue that will be affected by the defined stimulation field. The electrical field may be estimated by modeling the tissue around the complex electrode array geometry, and determining the propagation of the electrical field. The system may use the electrical field to determine stimulation parameters, and the user may desire to view the electrical field to review which structures of the anatomical region will be affected by the electrical field of the therapy. In addition to the electrical field, the system may apply a neuron model to the electrical field and use the resulting activation model to determine which tissues within the electrical field will be activated by the stimulation. The activation model may be provided to the user such that the user can accurately review which structures of the anatomical region will be activated by the stimulation. The activation model may allow a user to avoid stimulation of unwanted structures, and confirm that desired structures are stimulated.

FIG. 1is a conceptual diagram illustrating an example stimulation system with a stimulation lead implanted in the brain of a patient. As shown inFIG. 1, stimulation system10includes implantable medical device (IMD)20, lead plug22, lead wire24and lead14implanted within patient12. Specifically, lead14enters through cranium16and is implanted within brain18to deliver deep brain stimulation (DBS). One or more electrodes of lead14provides electrical pulses to surrounding anatomical regions of brain18in a therapy that may alleviate a condition of patient12. In some embodiments, more than one lead14may be implanted within brain18of patient12to stimulate multiple anatomical regions of the brain. As shown inFIG. 1, system10may also include a programmer19, which may be a handheld device, portable computer, or workstation that provides a user interface to a clinician. The clinician interacts with the user interface to program stimulation parameters.

DBS may be used to treat dysfunctional neuronal activity in the brain which manifests as diseases or disorders such as Huntington's Disease, Parkinson's Disease, or movement disorders. The exact reasons why electrical stimulation therapy is capable of treating such conditions of the brain is unknown, but symptoms of these disease can be lessened or eliminated with stimulation therapy. Certain anatomical regions of brain18are responsible for producing the symptoms of such brain disorders. For example, stimulating an anatomical region, such as the Substantia Nigra, in brain18may reduce the number and magnitude of tremors experienced by patient12. Other anatomical regions may include the subthalamic nucleus, globus pallidus interna, ventral intermediate, and zona inserta. Anatomical regions such as these are targeted by the clinician during lead14implantation. In other words, the clinician attempts to position the lead as close to these regions as possible.

While DBS may successfully reduce symptoms of some neurological diseases, the stimulation commonly causes unwanted side effects as well. Side effects may include incontinence, tingling, loss of balance, paralysis, slurred speech, loss of memory, and many other neurological problems. Side effects may be mild to severe; however, most side effects are reversible when stimulation is stopped. DBS may cause one or more side effects by inadvertently providing electrical stimulation pulses to anatomical regions near the targeted anatomical region. For this reason, the clinician typically programs the stimulation parameters in order to balance effective therapy and minimal side effects.

Typical DBS leads include one or more electrodes placed along the longitudinal axis of the lead, such as lead14. Each electrode is typically a ring electrode that resides along the entire circumference of the lead. Therefore, electrical current from the ring electrodes propagates in all directions from the active electrode. The resulting stimulation field reaches anatomical regions of brain18within a certain distance in all directions. The stimulation field may reach the target anatomical region, but the stimulation field may also affect non-target anatomical regions and produce unwanted side effects. Implanting a lead with a complex electrode array geometry may help to customize the stimulation field and provide improved therapy while decreasing side effects. In this manner, specific electrodes of the complex electrode array geometry may be selected to produce a stimulation field at desired portions of the circumference instead of always producing a stimulation field around the entire circumference of the lead. Also, the complex electrode array geometry may require a three dimensional method for a clinician to define which electrodes to use.

Lead14has a complex electrode array geometry in the preferred embodiment, but the lead may also include one or more single ring electrodes along the longitudinal axis in other embodiments. For example, the disclosure may be applicable to leads having all ring electrodes, or one or more ring electrodes in combination with electrodes at different axial positions and angular positions around the circumference of the lead. As an example, lead14includes a plurality of electrodes positioned at different axial positions along the longitudinal axis of the lead and a plurality of electrodes positioned at different angular positions around the circumference of the lead (which may be referred to as segmented electrodes). In this manner, electrodes may be selected along the longitudinal axis of lead14and along the circumference of the lead. Activating selective electrodes of lead14can produce customizable stimulation fields that may be directed to a particular side of lead14in order to isolate the stimulation field around the target anatomical region of brain18.

Producing irregular stimulation fields with a lead14with a complex electrode geometry not only allows system10to more effectively treat certain anatomical regions of brain18, but the system can also reduce or eliminate side effects from more spherical stimulation fields produced by a conventional array of ring electrodes. The center of the stimulation field may be moved away from lead14to avoid unwanted stimulation or compensate for inaccurately placed leads. If leads migrate within brain18slightly, a customizable stimulation field may provide a longer duration of effective therapy as stimulation needs of patient12change.

Programming lead14is more involved and complex when compared to traditional leads because of the increased number of possible electrode combinations and resulting stimulation fields. Effective programming may be difficult for the clinician if the clinician is required to systematically select each electrode of lead14in order to find the electrode combinations that provide therapy and minimal side effects. While the clinician may still desire the ability to manually select certain general areas of electrodes of lead14, e.g., the group of circumferential electrodes at one level or length of the lead, programming time may be reduced if the clinician uses a user interface that enables the clinician to define a stimulation field and automatically generate the stimulation parameters that would produce the stimulation field in patient12.

The user interface of programmer19displays a representation of the anatomical regions of patient12, specifically anatomical regions of brain18. The 3D space of the anatomical regions may be displayed as multiple 2D views or one 3D visualization environment. Lead14may also be represented on the display of the user interface, positioned according to the actual implantation location by the clinician or directly from an image taken of the lead within brain18.

The clinician interacts with the user interface to manually select and program certain electrodes of lead14, select an electrode level of the lead and adjust the resulting stimulation field with the anatomical regions as guides, or defining one or more stimulation fields only affect anatomical regions of interest. Once the clinician has defined the one or more stimulation fields, system10automatically generates the stimulation parameters associated with each of the stimulation fields and transmits the parameters to IMD20.

System10may provide the clinician with additional tools that allow the clinician to accurately program the complex electrode array geometry of lead14for therapy. These tools may include creating and displaying a stimulation template set that corresponds to the stimulation field defined by the clinician. The stimulation template set may indicate to the clinician the actual stimulation that will occur based upon the stimulation field. Alternatively, system10may provide an electrical field or activation field to the clinician that illustrates the exact structures of the anatomical region that will be affected by the stimulation field. The electrical field may be indicative of the electrical propagation through the tissue surrounding lead14, while the activation field may be indicative of the actual neurons within the electrical field that are activated by the therapy. Further, instead of or in addition to defining a stimulation field over an anatomical region of the patient, system10may provide a reference anatomical region of a reference anatomy, or an atlas, that allows the clinician to directly select the structures of the atlas that are targeted for therapy. The atlas may be mapped to the anatomical region of the patient anatomy or morphed together with the patient specific imaging to create a morphed atlas that indicates where each structure of the patient specific imaging resides. System10may then generate stimulation parameters to stimulate the selected structures. These alternative aspects of system10will be described in detail below.

Because clinicians are more familiar with physiology and anatomy than the operation and programming of stimulation parameters, clinicians may spend much less time configuring therapy for patient12by choosing what structures of the anatomical region should be stimulated. In some cases, system10may even indicate which structures the clinician has selected through the use of a pop-up bubble or structure list. Alternatively, the clinician may be able to select one or more specific outcomes from a list, e.g., outcome selection input, where the outcome is a common result of stimulation to one or more structures of patient12. Less clinician programming time with the user interface may result in a greater number of patients receiving effective therapy with potentially less side effects from time induced clinician mistakes.

The user interface provided in many different embodiments may allow a clinician to define a stimulation field which is used to generate stimulation parameters for IMD20and lead14. A first embodiment may utilize 2D views, or sections, of the anatomical regions of brain18. The clinician may place a lead icon over the anatomical regions in each 2D view to represent the actual location of implanted lead14. Once the lead icon is present, the clinician may select an electrode level and adjust the stimulation field position and magnitude by switching between different 2D views. Example 2D views may include coronal, sagittal, and axial slices of brain18.

Another embodiment is similar to the first embodiment in that multiple 2D views are provided to the clinician to represent the 3D anatomical regions. The clinician defines, with an outline for example, one or more stimulation fields on three 2D views of the anatomical regions of patient12. A 3D stimulation field volume is therefore defined by the 2D outlines and programmer19automatically generates appropriate stimulation parameters to at least approximate the defined field. The clinician may adjust the stimulation field by reviewing the 2D views and moving the outline. The outline may be established automatically by the programmer or the clinician may draw the outline using a stylus and touchscreen or other input media.

Further embodiments of system10allow the user to define a stimulation field on each of multiple 2D views in accordance to which structures of the anatomical region should be stimulated. System10then creates a stimulation template set that best fits the defined stimulation field. The stimulation template set that best fits the stimulation field may be presented to the clinician via the user interface over the defined stimulation field. If the clinician is not satisfied with the stimulation template set that is provided, the clinician may change the stimulation field until a template set is acceptable.

Other embodiments of system10provide an atlas to the clinician to reduce the difficulty of finding the desired structure to stimulate. In this case, the clinician may select the desired structure by selecting the structure from a simple drop down menu or from a graphical representation of the atlas. The atlas may be overlaid with the anatomical region of the patient anatomy for easy identification of structures of the patient. Alternatively, system10may generate a morphed atlas based upon the atlas and the patient anatomical region. Essentially, the locations of structures in the atlas are mapped to the patient anatomical region for selection.

Further embodiments of system10provide an electrical field model or an activation field model to the clinician over the anatomical region to indicate which structures will actually be affected by the defined stimulation. After defining the stimulation field and viewing the resulting electrical field or activation field, the clinician may be able to increase or decrease the amplitude to adjust the model according to what structures need to be stimulated by lead14.

An additional embodiment utilizes a 3D visualization environment that enables the clinician to view a 3D representation of anatomical regions of brain18. The clinician places a 3D stimulation field within the anatomical regions and manipulates the shape, size, and placement of the 3D stimulation field to stimulation the target anatomical regions. The clinician may rotate and zoom the view to see exactly what anatomical regions the stimulation field will reach. A 3D lead icon may be present to show the clinician how the stimulation field relates to the position of implanted lead14.

The 3D visualization environment may also incorporate an atlas, a morphed atlas, a stimulation template set, an electrical field model, or an activation model to assist the clinician in programming the stimulation therapy. The 3D environment allows the physician to rotate and zoom in on any portion of the 3D anatomical region represented in the 3D environment. The clinician can easily see which structures will be stimulated according to the defined stimulation field and which structures will be left unaffected. The 3D environment may reduce the amount of time the clinician must spend to initially program the stimulation therapy and optimize the therapy.

Other embodiments of the user interface are also contemplated, such as combinations of elements of the three embodiments described briefly above. For example, the clinician may select an electrode level of a lead icon in the 3D environment and manipulate the stimulation field provided by the electrodes of that electrode level. Some embodiments may begin with 2D views of the 3D anatomical regions and generate a 3D view of the defined stimulation field within the anatomical structures. In any embodiment, the user interface may restrict clinician defined stimulation fields based upon the stimulation abilities of IMD20and lead14. For example, the clinician may not make the stimulation field larger when the voltage cannot be increased or no more electrodes are available in the direction of the stimulation field. Additionally, the user interface may restrict the clinician from applying the stimulation field to an anatomical region or structure specifically banned from stimulation. Stimulation of these areas may severely alter the physiology of patient12and cause detrimental side effects or irreversible side effects.

The stimulation field defined by the clinician using a user interface described herein is associated with certain stimulation parameter values. Programmer19automatically generates the stimulation parameters required by the stimulation field and wirelessly transmits the parameters to IMD20. The parameters may also be saved on programmer19for review at a later time. In some cases, programmer19may not be capable of generating stimulation parameters that can produce the defined stimulation field within brain18. Programmer19may display an error message to the clinician alerting the clinician to adjust the stimulation field. Programmer19may also display a reason why the stimulation field cannot be provided, such as the field is too large or an electrode is malfunctioning and cannot be used. Other errors may also be displayed to the clinician.

Generally, the user interface is not used to provide real-time programming to IMD20. The clinician will use the user interface to define stimulation fields, and programmer19automatically generates the stimulation parameters when the clinician has determined the stimulation field is ready for therapy. In this manner, stimulation therapy perceived by patient12does not change at the same time the clinician changes the stimulation field. However, the user interface could be used as such in a real-time programming environment to provide immediate feedback to the clinician. In this manner,

System10may also include multiple leads14or electrodes on leads of other shapes and sizes. The user interface may allow the clinician to program each lead simultaneously or require the clinician to program each lead separately. In some DBS patients, two leads14are implanted at symmetrical locations within brain18for bilateral stimulation. In particular, a first lead is placed in the right hemisphere of brain18and a second lead is placed at the same location within the left hemisphere of the brain. Programmer19may allow the clinician to create a stimulation field for the first lead and create a mirrored stimulation field for the second lead. The clinician may be able to make fine adjustment to either stimulation field do accommodate the slight anatomical region differences between the left and right hemispheres.

While lead14is described for use in DBS applications throughout this disclosure as an example, lead14, or other leads, may be implanted at any other location within patient12. For example, lead14may be implanted near the spinal cord, pudendal nerve, sacral nerve, or any other nervous or muscle tissue that may be stimulated. The user interface described herein may be used to program the stimulation parameters of any type of stimulation therapy. In the case of pelvic nerves, defining a stimulation field may allow the clinician to stimulate multiple desired nerves without placing multiple leads deep into patient12and adjacent to sensitive nerve tissue. Therapy may also be changed if leads migrate to new locations within the tissue or patient12no longer perceives therapeutic effects of the stimulation.

FIGS. 2A and 2Bare conceptual diagrams illustrating two different implantable stimulation leads. Leads26and34are embodiments of lead14shown inFIG. 1. As shown inFIG. 2A, lead26includes four electrode levels32(includes levels32A-32D) mounted at various lengths of lead housing30. Lead26is inserted into through cranium16to a target position within brain18.

Lead26is implanted within brain18at a location determined by the clinician to be near an anatomical region to be stimulated. Electrode levels32A,32B,32C, and32D are equally spaced along the axial length of lead housing30at different axial positions. Each electrode level32may have two or more electrodes located at different angular positions around the circumference of lead housing30. Electrodes of one circumferential location may be lined up on an axis parallel to the longitudinal axis of lead26. Alternatively, electrodes of different electrode levels may be staggered around the circumference of lead housing30. In addition, lead26or34may include asymmetrical electrode locations around the circumference of each lead or electrodes of the same level that have different sizes. These electrodes may include semi-circular electrodes that may or may not be circumferentially aligned between electrode levels.

Lead housing30may include a radiopaque stripe (not shown) along the outside of the lead housing. The radiopaque stripe corresponds to a certain circumferential location that allows lead26to the imaged when implanted in patient12. Using the images of patient12, the clinician can use the radiopaque stripe as a marker for the exact orientation of lead26within the brain of patient12. Orientation of lead26may be needed to easily program the stimulation parameters by generating the correct electrode configuration to match the stimulation field defined by the clinician. In other embodiments, a marking mechanism other than a radiopaque stripe may be used to identify the orientation of lead14. These marking mechanisms may include something similar to a tab, detent, or other structure on the outside of lead housing30. In some embodiments, the clinician may note the position of markings along lead wire24during implantation to determine the orientation of lead14within patient12.

FIG. 2Billustrates lead34that includes more electrode levels than lead26. Similar to lead26, lead34is inserted though a burr hole in cranium16to a target location within brain18. Lead34includes lead housing38. Eight electrode levels40(40A-40H) are located at the distal end of lead34. Each electrode level40is evenly spaced from the adjacent electrode level and includes one or more electrodes. In a preferred embodiment, each electrode level40includes four electrodes distributed around the circumference of lead housing38. Therefore, lead34includes 32 electrodes in a preferred embodiment. Each electrode may be substantially rectangular in shape. Alternatively, the individual electrodes may have alternative shapes, e.g., circular, oval, triangular, or the like.

In alternative embodiments, electrode levels32or40are not evenly spaced along the longitudinal axis of the respective leads26and34. For example, electrode levels32C and32D may be spaced approximately 3 millimeters (mm) apart while electrodes32A and32B are 10 mm apart. Variable spaced electrode levels may be useful in reaching target anatomical regions deep within brain18while avoiding potentially dangerous anatomical regions. Further, the electrodes in adjacent levels need not be aligned in the direction as the longitudinal axis of the lead, and instead may be oriented diagonally with respect to the longitudinal axis.

Leads26and34are substantially rigid to prevent the implanted lead from varying from the expected lead shape. Leads26or34may be substantially cylindrical in shape. In other embodiments, leads26or34may be shaped differently than a cylinder. For example, the leads may include one or more curves to reach target anatomical regions of brain18. In some embodiments, leads26or34may be similar to a flat paddle lead or a conformable lead shaped for patient12. Also, in other embodiments, leads26and34may any of a variety of different polygonal cross sections taken transverse to the longitudinal axis of the lead.

Lead housings30and38may continue directly into lead wire24. A retention device may be used to squeeze the lead and shape it to approximately a 90 degree angle as it exits cranium16. In some embodiments, lead housing30or38may include a right angle connector that allows lead26and34to be inserted into cranium16via a burr hole cap. In embodiments of system10including two or more leads14, two or more leads may be connected to a common lead wire24. In this case, a connector at the surface of cranium16may couple each lead14to lead wire24.

FIGS. 3A-3Dare transverse cross-sections of example stimulation leads having one or more electrodes around the circumference of the lead. As shown inFIGS. 3A-3D, one electrode level, such as one of electrode levels32and40of leads26and34, respectively, are shown to include one or more circumferential electrodes.FIG. 3Ashows electrode level42that includes circumferential electrode44. Circumferential electrode44encircles the entire circumference of electrode level42. Circumferential electrode44may be utilized as a cathode or anode as configured by the user interface.

FIG. 3Bshows electrode level46which includes two electrodes48and50. Each electrode48and50wraps approximately 170 degrees around the circumference of electrode level46. Spaces of approximately 10 degrees are located between electrodes48and50to prevent inadvertent coupling of electrical current between the electrodes. Each electrode48and50may be programmed to act as an anode or cathode.

FIG. 3Cshows electrode level52which includes three equally sized electrodes54,56and58. Each electrode54,56and58encompass approximately 110 degrees of the circumference of electrode level52. Similar to electrode level46, spaces of approximately 10 degrees separate electrodes54,56and58. Electrodes54,56and58may be independently programmed as an anode or cathode for stimulation.

FIG. 3Dshows electrode level60which includes four electrodes62,64,66and68. Each electrode62-68covers approximately 80 degrees of the circumference with approximately 10 degrees of insulation space between adjacent electrodes. In other embodiments, up to ten or more electrodes may be included within an electrode level. In alternative embodiments, consecutive electrode levels of lead14may include a variety of electrode levels42,46,52or60. For example, lead14may include electrode levels that alternate between electrode levels52and60depicted inFIGS. 3C and 3D. In this manner, various stimulation field shapes may be produced within brain18of patient12. Further the above-described sizes of electrodes within an electrode level are merely examples, and the invention is not limited to the example electrode sizes.

Also, the insulation space, or non-electrode surface area, may be of any size. Generally, the insulation space is between approximately 1 degree and approximately 20 degrees. More specifically, the insulation space may be between approximately 5 and approximately 15 degrees. Smaller insulation spaces may allow a greater volume of tissue to be stimulated. In alternative embodiments, electrode size may be varied around the circumference of an electrode level. In addition, insulation spaces may vary in size as well. Such asymmetrical electrode levels may be used in leads implanted at tissues needing certain shaped stimulation fields.

FIG. 4is a functional block diagram of an example implantable medical device that generates electrical stimulation signals.FIG. 4illustrates components of IMD20, which can be utilized by any of the IMD embodiments described herein. In the example ofFIG. 4, IMD20includes a processor70, memory72, stimulation generator74, telemetry interface76, and power source78. As shown inFIG. 4, stimulation generator74is coupled to lead wire24(which includes lead14). Alternatively, stimulation generator74may be coupled to a different number of leads as needed to provide stimulation therapy to patient12.

Processor70controls stimulation generator74to deliver electrical stimulation therapy according to programs generated by a user interface and stored in memory72and/or received from programmer19via telemetry interface76. As an example, a new program received from programmer19may modify the electrode configuration and amplitude of stimulation. Processor70may communicate with stimulation generator74to change the electrode configuration used during the therapy and modify the amplitude of stimulation. Processor70may then store these values in memory72to continue providing stimulation according to the new program. Processor70may stop the previous program before starting the new stimulation program as received from programmer19. In some embodiments, amplitude of the stimulation signal may be ramped down or ramped up as a program is being turned off or turned on. In this manner, no abrupt stimulation changes may be perceived by patient12. A ramp up of the new program may provide patient12time to stop stimulation if the new program is uncomfortable or even painful.

Processor70may comprise any one or more of a microprocessor, digital signal processor (DSP), application specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other digital logic circuitry. Memory72stores instructions for execution by processor70, e.g., instructions that when executed by processor70cause the processor and IMD to provide the functionality ascribed to them herein, as well as stimulation programs. Memory72may include any one or more of a random access memory (RAM), read-only memory (ROM), electronically-erasable programmable ROM (EEPROM), flash memory, or the like.

Stimulation generator74may provide stimulation in the form of pulses to patient12. Alternatively, stimulation generator74may provide therapy in the form of some continuous signal such as a sine wave or other non-pulse therapy. Stimulation parameters for each stimulation program may include electrode configuration, current or voltage amplitude, pulse width, pulse rate, or duty cycle. Other parameters may be used depending on the therapy to be provided to patient12. Stimulation generator74may independently utilize any circumferential electrodes32or40or leads26and34, respectively. In this manner, stimulation generator74may be utilized to deliver stimulation via numerous different electrode configurations to provide therapy for a wide variety of patient conditions. In addition, stimulation generator74may test the functionality of electrodes on lead14. Based upon the impedance testing, specific electrodes may be removed from possible use in therapy when the test indicates that the impedance is above or below normal operating limits.

Telemetry interface76may include circuitry known in the art for facilitating wireless telemetry, e.g., via radio frequency (RF) communication or proximal inductive interaction with similar circuitry within external programmer19. Power source78delivers operating power to the components of IMD20. Power source78may include a battery and a power generation circuit to produce the operating power. In some embodiments, the battery may be rechargeable to allow extended operation. Recharging may be accomplished through proximal inductive interaction between an external charger and an inductive charging coil within IMD20. In other embodiments, non-rechargeable batteries may be used. As a further alternative, an external power supply could transcutaneously power IMD20whenever stimulation is needed or desired.

FIG. 5is a functional block diagram of an example programmer. As shown inFIG. 5, external programmer19includes processor80, memory82, user interface84, telemetry interface86, and power source88. Programmer19may be used to present anatomical regions to the user via user interface84, select stimulation programs, generate new stimulation programs with stimulation fields, and transmit the new programs to IMD20. As described herein, programmer19may allow a clinician to define stimulation fields and generate appropriate stimulation parameters. For example, as described herein processor80may store stimulation parameters as one or more programs in memory82. Processor80may send programs to IMD20via telemetry interface86to control stimulation automatically and/or as directed by the user.

Programmer19may be one of a clinician programmer or a patient programmer in some embodiments, i.e., the programmer may be configured for use depending on the intended user. A clinician programmer may include more functionality than the patient programmer. For example, a clinician programmer may include a more featured user interface, allow a clinician to download usage and status information from IMD20, and allow a clinician to control aspects of the IMD not accessible by a patient programmer embodiment of programmer19.

A user, either a clinician or patient12, may interact with processor80through user interface84. Any of the user interface embodiments described herein may be embodiments of user interface84, such as user interfaces90,314,380,456,554,600,652,730,798,850,876,916,964,1072,1114,1162,1198. User interface84may include a display, such as a liquid crystal display (LCD), light-emitting diode (LED) display, or other screen, to show information related to stimulation therapy, and buttons or a pad to provide input to programmer19. In embodiments where user interface84requires a 3D environment, the user interface may support 3D environments such as a holographic display, a stereoscopic display, an autostereoscopic display, a head-mounted 3D display, or any other display that is capable of presenting a 3D image to the user. Buttons may include an on/off switch, plus and minus buttons to zoom in or out or navigate through options, a select button to pick or store an input, and pointing device, i.e. a mouse, trackball, pointstick or stylus. Other input devices may be a wheel to scroll through options or a touch pad to move a pointing device on the display. In some embodiments, the display may be a touch screen that enables the user to select options directly from the display screen.

As described, the display may be more involved for the 3D user interface189. In this case, programmer19may be a workstation within a laboratory, clinic room, or surgical room. The clinician may need to immerse within the display to fully utilize the functionality of the user interface. In some cases, programmer19may be a hand held device for all features except the 3D environment when the 3D environment necessitates a larger system. However, programmer19may still be integrated with or communicate with the 3D environment to simplify system10for the user.

Processor80processes instructions from memory82and may store user input received through user interface84into the memory when appropriate for the current therapy. In addition, processor80provides and supports any of the functionality described herein with respect to each embodiment of user interface84. Processor80may comprise any one or more of a microprocessor, digital signal processor (DSP), application specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other digital logic circuitry.

Memory82may include instructions for operating user interface84, telemetry interface86and managing power source88. Memory82also includes instructions for generating stimulation fields and stimulation parameters from the stimulation fields. These instructions may include a set of equations needed to characterize brain tissue and interpret stimulation field dimensions. Memory82may include any one or more of a random access memory (RAM), read-only memory (ROM), electronically-erasable programmable ROM (EEPROM), flash memory, or the like. Processor80may comprise any one or more of a microprocessor, digital signal processor (DSP), application specific integrated circuit (ASIC), field-programmable gate array (FPGA), or other digital logic circuitry.

Memory82may store program instructions that, when executed by processor80, cause the processor and programmer19to provide the functionality ascribed to them herein. For example, memory82may include a plurality of stimulation templates that are used by processor80to create a stimulation template set. Memory82may also include instructions for generating stimulation parameters based upon the defined stimulation field. In addition, instructions that allow processor80to create electrical field models and activation field models may be stored within memory82. An atlas or reference anatomical region may also be stored in memory82for presentation to the clinician. In some embodiments, memory82does not contain instructions for all functionality for the user interfaces and programming of stimulation parameters as described herein. In this case, memory82may only hold the necessary instructions for the specific embodiment that the user desires. Memory82may be reformatted with different sets of instructions when needed.

Wireless telemetry in programmer19may be accomplished by radio frequency (RF) communication or proximal inductive interaction of programmer19with IMD20. This wireless communication is possible through the use of telemetry interface86. Accordingly, telemetry interface86may include circuitry known in the art for such communication.

Power source88delivers operating power to the components of programmer19. Power source88may include a battery and a power generation circuit to produce the operating power. In some embodiments, the battery may be rechargeable to allow extended operation. Recharging may be accomplished through proximal inductive interaction, or electrical contact with circuitry of a base or recharging station. In other embodiments, primary batteries may be used. In addition, programmer19may be directly coupled to an alternating current source, such would be the case with a stationary workstation for 3D visualization environments.

FIGS. 6-13describe an example embodiment of the user interface for programming stimulation therapy.FIG. 6is an example screen shot of a lead icon placed on a coronal view of brain tissue. As shown inFIG. 6, a representation of anatomical regions of brain18is displayed by user interface90. Programmer19displays coronal view92to the clinician, which is a front-back vertical section of brain18. Coronal view92may be an actual image of brain18produced with magnetic resonance imaging (MRI), computed tomography (CT), or another imaging modality. These images are used to produce the anatomical regions needed to help the clinician program the stimulation parameters.

Coronal view92is a 2D coronal slice of brain18. Differently shaded portions of coronal view92indicate varying densities of tissue within brain18. Darker portions indicate less dense tissue. For example, the darkest portion of coronal view92is indicative of spaces within brain18that contain cerebral spinal fluid (CSF). White portions of brain18indicate dense tissue and more neurons. The clinician may be able to recognize target anatomical regions by viewing coronal view92. It should be noted that coronal view92is only an example, and actual images may include a wider range of shades and higher image resolution. Coronal view92provides a first perspective of the lead and the anatomical region in which the lead is implanted.

Coronal view92includes lead icon94, pointer96, previous arrow98and next arrow100. The clinician uses pointer96to drag lead icon94into position on top of the anatomical regions to duplicate the position of lead14within brain18. Programmer19may initially orient the clinician to the middle depth of the coronal view92or another depth that the programmer automatically selects based upon they type of therapy, implant location, or some other simple indication of location. However, the clinician may use arrows98and100to move to another coronal depth where lead14is implanted in brain18.

Pointer96may be controlled with a mouse and buttons, a track-ball, touch-pad, or other movement input device. In addition, programmer19may include a touch screen to enable the clinician to use a stylus to click on the touch screen and drag lead icon94into position. Pointer96may also be used to rotate lead icon94within coronal view92to correctly orient the lead icon according to the actual position of lead14within brain18. In other embodiments, the clinician may first select the type of lead implanted within patient12and select the correctly scaled size of lead icon94to correspond with the anatomical regions of coronal view92.

The clinician may zoom in to or out of coronal view92for a larger view of anatomical regions of the coronal view. In addition, the clinician may move coronal view92up, down, left, or right to view a greater portion of brain18. Input mechanisms for adjusting coronal view92may be located on programmer19or directly within user interface92.

While the clinician may manually position lead icon94within coronal view92, user interface90may automatically position lead icon94based upon stereotactic data generated before lead14implantation is performed. A stereotactic frame may be placed on cranium16to specifically locate areas of brain18. In addition, this stereotactic information may be used to provide coordinates of the exact location of lead14implantation. In other embodiments, brain18may be imaged after implantation of lead14such that the lead is identifiable on coronal view92. The clinician may point to and identify electrodes of lead14in the image to allow programmer19to reconstruct the correct position of the lead. In some cases, programmer19may automatically identify lead14and place lead icon94correctly within the anatomical region without any input from the clinician.

Once lead icon94is correctly placed on coronal view92, the clinician may move to the next view of user interface90by selecting view button101to cycle through available orthogonal views. Coronal view92is only one 2D representation of brain18. Two more 2D views of brain18may be used to correctly orient lead icon94according to the implant orientation of lead14, including another axial view from the sagittal perspective and a cross-sectional view from the horizontal perspective.

FIG. 7is an example screen shot of a lead placed on a sagittal view of brain tissue. As shown inFIG. 7, user interface90includes sagittal view102of brain18. The anatomical regions represented in sagittal view102may be generated with the same imaging data used for coronal view92inFIG. 6. Sagittal view102also includes lead icon104, pointer106, previous arrow108and next arrow110, similar to lead icon94, pointer96, previous arrow98and next arrow100FIG. 6. The clinician may zoom in and out of sagittal view102and move the view to the left, right, up and down.

The initial placement of lead icon104corresponds to the position determined in coronal view92ofFIG. 6. The clinician uses pointer106to drag lead icon104into its correct place among the represented anatomical regions. The clinician may also rotate lead icon104if necessary to match the orientation of lead14implanted within patient12. Programmer19may initially orient the clinician to the depth of sagittal view102that corresponds to the initial placement of lead icon94in view92. However, the clinician may use arrows108and110to move to another sagittal depth where lead14is implanted in brain18.

In the example of Parkinson's disease, stimulation therapy is generally directed to an anatomical region of brain18identified as the Substantia Nigra (SN). Simulation of the SN is generally regarded as a mechanism to reduce the motor tremors associated with Parkinson's disease. The clinician uses sagittal view102, and coronal view92, to locate lead icon14near the SN because lead14is implanted near the SN. Stimulation of adjacent non-target anatomical regions of brain18may produce side effects in patient12. In some embodiments, the clinician may target the Subthalamic Nucleus, instead of or in addition to the Substantia Nigra.

Similar to coronal view92, lead icon104may be automatically placed in the proper position of sagittal view102or the actual location of lead14may be shown to allow a user to correct the orientation of lead icon104. Once lead icon104is correctly positioned, the clinician may move to an axial view (or another previous view such as sagittal or coronal) by pressing view button111to finish orienting lead icon104within user interface90.

FIG. 8is an example screen shot of a lead placed on an axial view of brain tissue. As shown inFIG. 8, user interface90provides axial view112. Axial view112displays pointer116, lead icon114, previous arrow118and next arrow120. The initial position of lead icon114is determined by the positioning of lead icons94and104inFIGS. 6 and 7. The clinician uses pointer116to rotate lead icon114such that the lead icon is correctly oriented in the circumferential direction according to implanted lead14. Programmer19may initially orient lead icon114to the axial depth of axial view112. However, the clinician may use arrows118and120to move to another coronal depth where lead14is implanted in brain18.

Lead icon114includes stripe115extending from the lead icon that corresponds to a radiopaque stripe or other marker on lead14. The clinician matches the stripe location to match lead14orientation such that stimulation parameters, including electrode configurations, are correct. Once the rotation of lead icon top114is complete, the lead icon is correctly positioned within user interface90. The stripe aids the user in maintaining a sense of spatial relationship between the lead and the anatomical structure.

In some embodiments, lead14may not actually be completely perpendicular with axial view112. Even though the orientation of lead icons94,104and114and lead14may not be perfectly matched, the generally matched orientations may be sufficiently accurate to effectively program stimulation therapy. In other embodiments, axial view112may display lead icon114as a slightly oblique view of that illustrated inFIG. 8to match the actual placement of lead14within brain18.

After correctly orienting lead icons94,104and114within user interface90, the clinician may define stimulation fields that can be transposed from the user interface to IMD20. At any time during the programming process, the clinician may return to re-position lead icons94,104, or114if the placement is not accurate. The clinician may select view button121to cycle through the other views. In some embodiments, programmer19may display one or more of coronal view92, sagittal view102, or axial views102at the same time to allow the clinician to simultaneously position lead icons94,104and114and continue programming therapy. In alternative embodiments, the correct placement of lead icon94may not lie within one of the coronal view92, sagittal view102, or axial view102. Instead, lead icon94may lie within an oblique view, e.g., a view in a plane not parallel to one of the aforementioned orthogonal views. In this case, the clinician may be able to request that programmer19generate and present the oblique view with or without lead icon94to facilitate stimulation programming. In addition, programmer19may be able to display other orthogonal views to the oblique view, wherein the oblique or orthogonal view allows the clinician to view down the central axis of lead icon94.

FIG. 9is an example screen shot of stimulation field selection on a coronal view of brain tissue. As shown inFIG. 9, field view122of user interface90allows the clinician to select and adjust one or more stimulation fields. Field view122includes lead icon124, pointer126, stimulation field136, fine control142, control slide144, previous arrow138, and next arrow140. Lead icon124is similar to lead icon94ofFIG. 6, but the clinician may user pointer126to select one of electrode levels128,130,132or134to place a stimulation field over the selected electrode level. An electrode level may have one or more electrodes around the circumference of lead icon124, e.g., a complex electrode array geometry. All circumferential electrodes of the selected electrode level are initially activated for programming. Generally, the clinician attempts to place stimulation field136over the anatomical regions targeted for stimulation therapy while avoiding anatomical regions that may initiate unwanted side effects. In some embodiments, stimulation field136may be a representation of an electrical field, current density, voltage gradient, or neuron activation, applied to a generic human tissue or the anatomy of patient12. In addition, the clinician may be able to switch between any of these representations when desired.

The clinician selected electrode level132and stimulation field136shows the anatomical region that would be stimulated with the electrode level. The clinician may use pointer126to drag stimulation field136to a smaller or larger size that corresponds to a lower or higher voltage or current amplitude. For example, the user may click on a border, or perimeter of the field, and then drag the border to expand or contract the field. This adjustment is the coarse control of the size of stimulation field136. The clinician may use pointer126to move control slide144up to slightly increase the size of stimulation field136or down to slightly decrease the size of stimulation field136. In some embodiments, the actual voltage or current amplitude associated with stimulation field136is displayed on field view122as the field changes.

When a user clicks on the field border and drags it, the entire field may be expanded in two dimensions in equal proportions. Alternatively, the field may expand only in the direction in which the user drags the field. For example, horizontal dragging of the field perimeter to enlarge the field may result in overall enlargement of the field, keeping the vertical to horizontal aspect ratio constant. Alternatively, horizontal dragging may result only in horizontal expansion, leaving the vertical dimension constant. The application of a constant or varying aspect ratio may be specified by a user as a user preference. Alternatively, the programmer may provide different aspect ratio modes on a selective basis for expansion and shrinkage of the field. Programmer19may limit the rate of movement of stimulation field136. In other words, stimulation field136may only be moved a certain number of steps per second within user interface136, or any other user interface that allows the clinician to drag the stimulation field. This rate movement limit may prevent unnecessary calculations or ensure patient comfort in real-time changing of stimulation parameters with modifications of stimulation field136.

The initial size of stimulation field136may be determined by a minimal threshold voltage previously determined effective in brain18. In other embodiments, the initial stimulation field size may be small to allow the clinician to safely increase the size of stimulation field136. The size of stimulation field136may be limited by a volume parameter or a maximum voltage limit previously defined by user interface90. The limit may be associated with capabilities of IMD20or safe voltage or current levels. Once the size of stimulation field136is met, the clinician may no longer be able to drag the size of the stimulation field away from lead icon124.

Stimulation field136may grow or split in size if the clinician selects more than one electrode level128,130,132or134. For example, the clinician may select electrode levels92and86to generate stimulation fields associated with each electrode level. The clinician may also move stimulation field136along the length of lead icon124and user interface may automatically select which electrode levels to activate to produce the stimulation field on field view122. The clinician may also move to other depths or slices of coronal view122with arrows138and140. The clinician may continue to adjust the stimulation therapy on an axial view or other view by selecting view button141to cycle through other orthogonal views.

FIG. 10is an example screen shot of stimulation field adjustment on an axial view of brain tissue. As shown inFIG. 10, user interface90includes adjust view146and lead icon148(similar to lead icon114). The size and location of stimulation field152on the axial view of brain tissue indicates the anatomical regions that would receive electrical stimulation. The user may use pointer150to drag the position of stimulation field152and increase or decrease the size of the stimulation field.

Dragging stimulation field152away from the center of lead icon148, e.g., offsetting or directing the stimulation field in a radial direction from the lead icon, would require that the multiple electrodes of an electrode level have different voltage or current amplitudes. InFIG. 10, electrodes on the side of lead icon148with the greater portion of stimulation field152must generate a greater voltage or current amplitude than electrodes on the opposite side of lead icon148. Limitations of electrode locations, voltage or current capabilities, or physiological safe guards may limit the clinician of moving stimulation field152to certain locations of adjust view146. In some embodiments, the clinician may use pointer150to modify stimulation field152shape to a non-circular shape such as an ellipse or curved field. In some embodiments, user interface90may present an error message to the clinician if stimulation field152cannot be supported by system10.

The clinician moves stimulation field152in adjust view146to create the most effective stimulation therapy program. The clinician uses the anatomical regions represented by user interface90to focus electrical stimulation to target anatomical regions and avoid side effects from the stimulation of surrounding tissue. Specifically, this trade-off between maximum therapeutic effects and minimal side effects is how patient12may evaluate the success of the stimulation therapy.

The clinician may continue to evaluate other electrode levels by selecting previous arrow154and returning to field view122. Alternatively, the clinician may use arrows154and156to move to other axial depths and view other cross-sections of the volumetric stimulation field partially defined by stimulation field152. The clinician may also return to other views by selecting view button157. Once the clinician is satisfied with the orientation of the stimulation field, the clinician may press a “generate” or “apply” button on programmer19or provided by user interface that causes programmer19to generate a program of the stimulation parameters necessary to produce the stimulation field in patient12. The clinician may generate multiple programs for patient12to evaluate during the course of therapy. In some cases, patient12may prefer one program over another depending on the activity of the patient. The programs are transmitted from programmer19to IMD20for therapy to begin.

In some embodiments, adjust view146may include a control that allows the clinician to scroll through various axial depths of the anatomical regions. In this manner, the clinician may identify the shape of the stimulation field at various locations along the longitudinal length of lead icon124ofFIG. 9. In other embodiments, adjust view146may include a depth chart to show the clinician where the 2D axial view is in relation to the lead icon124. In systems that include more than one lead14implanted within patient12, user interface90may provide lead representations of two or more of the leads instead of just a single side and cross-sectional view of one lead.

FIG. 11is a flow diagram illustrating an example technique for implanting a stimulation lead in a brain of a patient. As shown inFIG. 11, patient12is imaged using an MRI or CT scanner. In particular, brain18is scanned to create the representation of anatomical regions (158). Either shortly after or several days later, patient12is prepared for surgery and implantation of lead14(160). Preparation may include generating stereotactic information with a stereotactic frame attached to cranium18. The implant site may also be precisely located and images of brain18reviewed to identify any abnormalities of brain18.

Once in surgery, the clinician creates a burr hole in cranium16of patient12(162). The clinician inserts lead14into brain18and places the lead near the target anatomical regions (164). The clinician next tests if lead14is correctly placed in brain18(166). The clinician may use micro recordings or patient feedback to identify results from small electrical stimulation of brain18. If lead14is not correctly placed, the clinician may reposition lead14(164). If lead14is correctly placed in brain18, the clinician secures lead14within brain18and reattaches patient12scalp (168). The clinician may also tunnel lead wire24to IMD20and implant the IMD.

In some embodiments, lead14may be implanted in a different manner. For example, lead14may be implanted with a robotic assistant using a map of brain18to increase the accuracy of lead placement. In other embodiments, more leads may be implanted within brain18for stimulation therapy as well.

FIG. 12is a flow diagram illustrating an example technique for positioning a lead icon over anatomical regions of a patient. More particularly, the clinician places lead icons94,104,114within respective views to correspond to the correct location of lead14within brain18. The clinician enters the brain imaging data into user interface90(170). The clinician selects the coronal view (172) and drags lead icon94to the appropriate location within the coronal view (174). Next, the clinician selects the sagittal view (176) and drags lead icon104to the correct location within the anatomical regions represented within the sagittal view (178).

The clinician next selects the axial view (180) and rotates the lead icon114to correctly orient the stripe of the lead icon within brain18(182). Once lead icon114is correctly placed, the clinician proceeds to determine the therapeutic configuration of the stimulation parameters (184). In other embodiments, lead icons94,104and114may be automatically placed in user interface90based on an image taken post-implant, and the clinician may review the placement to look for placement errors. The order of lead icon placement may be switched in some embodiments as well.

FIG. 13is a flow diagram illustrating an example technique for adjusting the stimulation field for stimulation therapy. As shown inFIG. 13, the clinician begins by selecting an electrode level in field view122of user interface90(186). All electrodes, i.e., electrodes at different angular positions around the lead circumference, in the electrode level are active. The clinician adjusts the stimulation field136size (188) and proceeds to test the stimulation field on patient12to determine the therapeutic effect, if any (190). If there are more electrode levels to try (192), the clinician repeats this process by selecting another electrode level and testing it on patient12.

If there are no more electrode levels to test, the clinician selects the most effective electrode level (194) and adjusts the stimulation field size again in field view122(196). The clinician next drags the stimulation field in adjust view146to minimize side effects and maximize the therapy (198). The clinician may return to field view122and fine adjust the stimulation field (200). In some embodiments, the clinician may adjust the simulation field in any of sagittal, coronal, or axial field views as desired by the clinician. In other embodiments, user interface90may require that the clinician enters each of the sagittal, coronal, and axial field views at least once before adjustment of the stimulation can be completed. Once the stimulation field is adjusted to produce effective therapy, the clinician saves the electrode configuration and other stimulation parameters as a stimulation program and transmits the program to IMD20(202). In some embodiments, the clinician may repeat the programming procedure with user interface90to create multiple stimulation programs. The clinician may also reprogram the therapy at any time.

Programmer19uses the information received via user interface90to automatically generate stimulation parameters according to the stimulation field defined by the clinician. The user interface determines the dimensions of the stimulation field to create a 3D vector field identifying the distances from lead14that stimulation may reach. Programmer19uses the 3D vector field with an equation approximating electrical current propagation within brain18tissue. The resulting data determines the electrode combination, voltage and current amplitudes, pulse rates, and pulse widths needed for reproducing the stimulation field within patient12. In other embodiments, programmer19interprets density of tissue in the imaging data to more precisely approximate the stimulation parameters.

FIGS. 14A-14Fare conceptual diagrams illustrating different stimulation fields produced by combinations of electrodes from the complex electrode array geometry. As shown inFIGS. 14A-14F, the potential stimulation fields along the length of lead204are shown, where lead206is an embodiment of lead14. Stimulation fields are shown along only one side of lead206; however, similar stimulation fields may be produced between other electrodes around the circumference of lead206. The stimulation fields may be similar to a stimulation template for that electrode configuration, where a stimulation template is a predetermined stimulation volume that is defined by a set of stimulation parameters. As mentioned previously, a stimulation template may be a volumetric stimulation field defined by stimulation parameters. Programmer19may include a certain number of stimulation templates that are used to automatically generate stimulation parameters that best fit a user defined stimulation field. In addition to the stimulation fields shown with lead206, reversing the polarity of the electrodes that produce each stimulation field may result in a similar stimulation field, but have a different therapeutic effect on patient12.

FIG. 14Aillustrates electrode configuration204providing one stimulation field210that is formed from designating electrode208A as the anode and electrode208C as the cathode. Stimulation field210could be similarly produced by any other adjacent electrode pair, such as electrodes208A and208B.FIG. 14Billustrates electrode configuration205that includes stimulation fields212and214. Stimulation field212is produced by electrode208A as an anode and electrode208B as a cathode. Stimulation field214is produced by electrode208C as a cathode and electrode208D as an anode. Electrode configuration205may be used when different structures of the anatomical region are desired to be stimulated.

FIGS. 14C and 14Dillustrate larger stimulation fields that are produced from overlapping smaller stimulation fields.FIG. 14Cpresents electrode configuration207that includes stimulation fields216and218. Stimulation fields16and17are created by anode electrode208B and cathode electrodes208A and208C.FIG. 14Dpresents electrode configuration209that includes stimulation fields220,222and224. Stimulation field220is produced by electrodes208A and208B, stimulation field222is produced by electrodes208B and208C, and stimulation field224is produced by electrodes208C and208D. Polarity of collective electrodes208may be altered while maintaining the stimulation fields of electrode configuration209.

FIGS. 14E and 14Fprovide examples of stimulation fields that span over inactivated electrodes.FIG. 14Eillustrates electrode configuration211of electrodes208A and208C that produce stimulation field226. Stimulation field226covers electrode208B without activating the electrode. Activating electrode208B as an anode or cathode may affect the shape of stimulation field226.FIG. 14Fillustrates electrode configuration213of active electrodes208A and208B. Stimulation field228overlaps inactive electrodes208B and208C. The polarity of either electrode configurations211or213may be changed without modifying the shape of the corresponding stimulation field; however, the tissue treated by these stimulation fields may be affected differently.

FIGS. 15A-15Dare conceptual diagrams illustrating possible cross-sections of stimulation templates for electrodes of two adjacent levels of a complex electrode array geometry. A stimulation template is a predetermined volumetric stimulation field that programmer19can use to match to a desired stimulation field from the clinician. Each stimulation template may be based upon any one or combination of modeled data, experimental data, or analytical calculations prior to being stored in programmer19. Cross-sections of example stimulation templates are provided to illustrate possible fields around the circumference of implanted lead14.FIGS. 15A-15Dillustrate possible cross-sections of stimulation templates of an electrode of one electrode level paired to another electrode at another electrode level at the same circumferential position. Even through only cross-sections of stimulation templates are shown, they will be referred to as a stimulation template for simplicity. When creating a stimulation template set to provide stimulation therapy, system10may use such stimulation templates to create the stimulation template set. If only one electrode template is chosen, at least one other electrode above or below the selected electrode must also be used to create the stimulation template. In other embodiments, similar stimulation templates may be created for complex electrode array geometries having more or less than four electrodes in a given electrode level. The stimulation template may not indicate the exact shape of the resulting stimulation field, as the tissue adjacent to the electrode may affect the propagation of the electrical stimulation. In alternative embodiments, programmer19may only store one volumetric stimulation template per electrode combination and scale each template as needed to the size of the stimulation field. In other words, programmer19may adjust the current or voltage amplitude to increase or decrease the volumetric stimulation template to best fit the stimulation field.

While generally bipolar electrode combinations are described herein, volumetric stimulation templates may include unipolar electrodes. Unipolar electrodes may be anodes or cathodes that are combined with an electrode to complete the circuit that is located on the housing of stimulator12or some other location not on lead14. Unipolar electrodes may allow for increased flexibility in programming effective therapy.

FIG. 15Ashows electrode232and corresponding cross-section of idealized stimulation field234that is included in template230.FIG. 15Bshows electrode238and corresponding cross-section of idealized stimulation field240that is included in stimulation template236.FIG. 15Cincludes stimulation template242which includes electrode244and corresponding cross-section of idealized stimulation field246adjacent to the electrode.FIG. 15Dindicates that stimulation template248includes electrode250and corresponding cross-section of idealized stimulation field252. The actual shape of each stimulation template may vary depending upon the surrounding tissue to the implanted lead. However, system10may use the idealized stimulation templates as approximate stimulation templates for the purpose of matching the best template to the user defined stimulation field. For all stimulation templates, system10may be able to adjust the current amplitude or voltage amplitude to alter the size of the stimulation field provided by the stimulation template to cover the desired stimulation field identified by the clinician. In addition, system10may combine any of the stimulation templates230,236,242and248to stimulate tissue at certain locations around the lead. In some embodiments, polarity of an electrode of a stimulation template may be changed to accommodate the combine stimulation templates, or stimulation template set.

FIG. 16is a flow diagram illustrating an example technique for creating a template set from volumetric stimulation templates stored in programmer19. As shown inFIG. 16, system10may use stimulation templates stored within programmer19to create a stimulation template set that defines the stimulation therapy for patient12. Once programmer19has received stimulation field input from the clinician, processor80of programmer19retrieves volumetric stimulation templates from memory82that best correlate to the stimulation field input from the clinician (254). Each stimulation template may be stored as a volumetric stimulation template and compared to the stimulation field input by processor80. In some cases, processor80may use an iterative process to find the best one or more stimulation templates that fit the stimulation field input, e.g., step-by-step narrowing of templates according to most important variables first and less important variables next. In other embodiments, processor80may use a point field in which each template is labeled with the points the template includes. The template, or templates, with points most closely matching the stimulation field input may be selected. Storing volumetric stimulation templates may effectively reduce the time needed to find a stimulation template by limiting possible templates to only those capable of being created by the complex electrode array geometry. If template small sections or 2D slices were employed, constructing a viable volumetric template that can be produced by the complex electrode array geometry may be time consuming or computation intensive.

If the clinician has loaded patient anatomy data for the anatomical region (256), processor80receives the patient anatomy data and data indicating the location of the one or more leads implanted within brain18(258). The patient anatomy data may be information created by an imaging modality such as magnetic resonance imaging (MRI), computed tomography (CT), or positron emission tomography (PET). The patient anatomy set may be used as a “map” of the patient anatomical structure. The location of the lead may be determined by stereotactic techniques or a post-implant image of the lead with respect to the anatomy. Processor80next correlates the patient anatomy data to the lead location in order to create a single coordinate system (260). Next, processor80slices the volumetric stimulation template to create a cross-section that can be displayed in accordance with the stimulation field input from the clinician (262). If there is no patient anatomy data (256), processor80proceeds directly to slice the volumetric stimulation template as needed. Since the patient anatomy data set may only be used to display the stimulation field and template over the anatomical region of the patient, some embodiments may display the template and stimulation field without the patient anatomy data.

Processor80next determines if the anatomical region should be displayed on user interface84. If there is no anatomical region to be displayed, processor80will directly add the necessary stimulation templates, if there are more than one needed, to create the “best fit” stimulation template set to treat patient12, e.g., the stimulation template set that best matches the desired stimulation field as indicated by the clinician. If the anatomical region is to be displayed to the clinician, processor80maps the stimulation templates to the patient anatomical region (266) and adds the templates together to create the stimulation template set (268). Processor80presents the stimulation template set to the user for review and verification (270). If there is an anatomical region to display to the clinician in addition to the stimulation template set, user interface84will display the stimulation template set over the associated areas of the anatomical region.

Each stimulation template may be stored as a set of equations that govern the template. For example, variables of the template equations may be stimulation parameters such as voltage amplitude, current amplitude, pulse rate, pulse width, or frequency. A clinician may change proposed stimulation parameters by modifying the stimulation field input or directly change the size of the stimulation template on user interface84. Changes in the stimulation field input will affect the size or selection of the stimulation template set, and changes in the size of the stimulation template will affect the stimulation parameters. Other variables may include physical parameters such as electrode size, shape, and curvature. In less complicated embodiments, each electrode may have a predefined number of possible templates that are defined by predetermined stimulation parameters. In this manner, processor80selects the template that best fits defined stimulation field from the clinician, compiles each template, and creates the stimulation template set. In some embodiments, system10may store and process stimulation templates differently. For example, the clinician may even search memory82for possible templates to manually create a stimulation template set or adjust a previously created stimulation template set.

FIGS. 17A and 17Bare conceptual diagrams illustrating a template set that does not target any tissue outside of a defined stimulation area. As shown inFIG. 17A, the clinician has defined stimulation field276in relation to one level of lead274in view272. Stimulation field276outlines the area of an anatomical region (not shown) that the clinician desires to stimulate.FIG. 17Billustrates stimulation template set288in view278that processor80creates according to stimulation field276. In the example ofFIG. 17B, the processor creates the stimulation template set with the highest priority of not affecting areas of the anatomical region outside of stimulation field276. The next highest priority for processor80is to create a stimulation template set288that affects as much of the area within the stimulation field area as possible. Template set288is created by an anode electrode282and cathode electrode284of lead274. While a larger template set288may be able to stimulate more of the area within stimulation field286, the additional stimulated tissue may cause unwanted side effects to patient12. The clinician may use the similar process for each level of lead274to treat other areas of the anatomical region along the length of the lead. In some embodiments, the priorities of when to avoid non-target tissue, cover non-target tissue, or some combination of covered target and non-target tissue may be variable based upon the type of stimulation therapy or user adjustable.

FIGS. 18A and 18Bare conceptual diagrams illustrating a template set that targets all tissue within a defined stimulation area. As shown inFIG. 18A, the clinician has defined stimulation field294in relation to one level of lead292in view290. Stimulation field294outlines the area of an anatomical region (not shown) that the clinician desires to stimulate.FIG. 18Billustrates stimulation templates310and312that processor80creates according to stimulation field294. In the example ofFIG. 17B, the processor creates the stimulation template set with the highest priority of stimulating all tissue areas within stimulation field308. Next, processor80attempts to stimulate the least amount of tissue outside of stimulation field308. This method of creating template sets may cause side effects to patient12with the benefit of possibly treating the entire patient condition. Template310is created by an anode electrode302and cathode electrode304of lead298. Template312is created by an anode electrode306and cathode electrode308of lead298. Templates310and312together create the stimulation template set for therapy, but only a cross-section of the volumetric stimulation template is displayed. In addition, templates310and312are only idealized estimations of the actual stimulation field produced within patient12. However, this estimation may be adequate to aid the clinician in programming the stimulation therapy of a complex electrode array geometry. The clinician may use the similar process for each level of lead292or298to treat other areas of the anatomical region along the length of the lead.

FIGS. 19-22are illustrative of another embodiment of this disclosure intended to allow physicians to focus on patient anatomy.FIGS. 19-22may generate stimulation parameters according to predetermined stimulation equations, stored stimulation templates, or another method of generating parameters based upon the defined stimulation field.FIG. 19is an example screen shot of an outline of a stimulation field placed on a coronal view of brain tissue. As shown inFIG. 19, user interface314is displayed on programmer316, which may be substantially similar to programmer19described above with reference toFIG. 5. User interface314includes coronal view318of brain18. Also shown on coronal view318are pointer330, stimulation field328, previous arrow320, next arrow322, menu324, and view indicator326. Stimulation field328is a cross-sectional view of volumetric stimulation field, which is further defined in other orthogonal views. Coronal view318is a 2D slice of a 3D image of brain18. White areas indicate dense neuronal tissue while dark areas indicate generally fluid filled area, where the fluid is CSF.

The clinician begins by examining the anatomical regions displayed in coronal view318. The clinician identifies the target anatomical regions that should be stimulated to treat patient12. In the example of Parkinson's disease, the clinician identifies the SN and other structures of brain18. The clinician moves pointer330to create an outline defining the outer edges of the stimulation field. While a representation of lead14is not shown on coronal view318, other embodiments may show a lead icon for a starting point.

The clinician may zoom in or out of an area of coronal view318. In addition, the clinician may move coronal view right, left, up or down to isolated areas of interest. Zoom may be of interest to the clinician when outlining the target anatomical region in order to fine tune the resulting stimulation field. Programmer may set limit boundaries to the outline that the clinician may generate. These limit boundaries may be shown on coronal view318. In some embodiments, user interface314may allow the clinician to move up or down to view cross-section coronal views in other depths of brain18using arrows320and322. This movement through 2D slices may allow the clinician to identify each area of stimulation field328throughout the 3D stimulation field represented by user interface314.

The clinician may select menu324to view or change preferences of user interface314. For example, preferences may be appearance preferences such as brightness or contrast of the display of programmer316. Alternatively, the clinician may select the manner in which programmer316determines the stimulation parameters based upon stimulation field330when the clinician has completed defining the stimulation field and stimulation parameters can be generated. Pressing menu324may bring up a pop-up window that includes the menu choices for the clinician. View indicator326allows the user to change to a different 2D view of the anatomical region, such as sagittal or axial views. “Coronal” is highlighted to indicate that the current view is a coronal section of brain18. Previous arrow320and next arrow322may allow the clinician to move between slices of adjacent depths of brain18and the stimulation field328in relation to the anatomical region of the other depths.

In some embodiments, user interface314may include a wand tool, e.g., a virtual automatic selection based upon one selected point, that the clinician can use to select an area. Then, all pixels of that same shade of color may be outlined or highlighted. In this manner, the physician may select all anatomical regions of the same density which may be indicative of an entire target region. The clinician may define the range of pixel shade, e.g., allowable variability in tissue density, with one selection. The clinician may then modify the automatically selected area to provide greater flexibility in stimulation field selection. Alternatively, the clinician may manually modify the outlined area after using the wand tool.

The benefit to the clinician outlining desired areas includes allowing the clinician to focus on the anatomy and physiology of patient12instead of manipulating an implanted device. The clinician is an expert at understanding the anatomy and physiology of patient12, but may not be as adept at understanding then the effect of different combinations of stimulation parameters on the stimulation delivered by an IMD. Consequently, automatically generating stimulation parameters according to the desired stimulation area may increase therapy efficacy and decrease programming time.

In other embodiments, user interface314may allow the clinician to use a stylus or finger on a touch screen to define the stimulation field and outline. In alternative embodiments, user interface314may identify and label certain anatomical regions to help guide the clinician in quickly orienting the stimulation field to brain18of patient12.

FIG. 20is an example screen shot of an outline of a stimulation field placed on a sagittal view of brain tissue. Since the defined stimulation field is three dimensional, the clinician must outline the stimulation field on three 2D views, rather than just the coronal view ofFIG. 19. As shown inFIG. 20, the clinician uses pointer344to create stimulation field342within sagittal view332of user interface314. Stimulation field342defines the structures of the anatomical region that the clinician desires to stimulate. Stimulation field342is also a cross-sectional view of volumetric stimulation field, which is further defined by other orthogonal views, such as the cross-section stimulation field328of coronal view318. Previous arrow334and next arrow336may be used to move to other slices of the sagittal plane of the anatomical region, while menu338may be selected and used similar to menu324. View indicator340also highlights the word “Sagittal” to remind the clinician which plane of the anatomical region the clinician is viewing. Similar toFIG. 19, the clinician may zoom in and out of sagittal view332and move the view to display different areas within the current slice of the sagittal plane. Additionally, the clinician may use a wand tool to select a range of pixel shades to quickly select anatomical regions that will be included in the stimulation field.

FIG. 21is an example screen shot of an outline of a stimulation field placed on an axial view of brain tissue. As shown inFIG. 21, user interface314is provided by programmer316and includes axial view346that displays pointer358, stimulation field356, previous arrow348and next arrow350. Simulation field356is a cross-section of the volumetric stimulation field defined in views318and322. User interface314also includes view indicator354. Similar to coronal view318and sagittal view332, the clinician uses pointer358to create an outline of stimulation field356around target structures of the anatomical region.

The clinician may make adjustments to stimulation field356in axial view346or using previous arrow348and next arrow350to step up or down in axial slices of brain18. The clinician may also go back and forth between views318,332and346to make fine adjustments to the stimulation field defined by the outlines in the three orthogonal views. Similar toFIGS. 19 and 21, the clinician may zoom in and out of axial view346, as well as move the view to the right, left, up and down of the anatomical region. The clinician may also use a wand tool to select similar pixels in the same area.

Once all stimulation fields328,342and356are complete, the clinician may have programmer316automatically generate stimulation parameters associated to the 3D stimulation field defined by stimulation fields328,342and356. The clinician may test the stimulation field on patient12and adjust the stimulation parameters, if necessary. In other embodiments, stimulation fields328,342and356are not all defined from separate outlines. For example, once stimulation field328is defined, programmer316may display a line that indicates the different orthogonal view to aid the clinician in creating stimulation field342, both of which are cross-sections of the volumetric stimulation field actually produced in therapy. Alternatively, programmer316may use stimulation field328to estimate an initial volumetric stimulation field which determines the starting point for stimulation field342that the clinician modifies. In any case, the order in which the clinician accesses views318,332, and346to create stimulation fields328,342, and356may be changed by the clinician or alternative instructions stored in memory82programmer316.

User interface314may include limits to the shape and size of the outline from the clinician. In some embodiments, processor80may use stimulation templates to generate the stimulation parameters requested by the stimulation field, as described previously. In other embodiments, stimulation parameter equations may be used to determine the appropriate stimulation parameters that will satisfy the stimulation field. In the case where stimulation parameters cannot create an identical match to the defined stimulation field, user interface314may provide a percent under or over indication to the clinician that indicates the error of the best fit stimulation field. User interface314allows the clinician to focus on structures of the anatomical region without worrying about the exact position of lead14within brain18. Processor80will compare the position of the stimulation field to the actual lead position. If the defined stimulation field cannot be satisfied because it is out of range of lead14, a warning message may be delivered to the clinician via user interface314. Otherwise, processor80will determine parameters for delivery of stimulation via lead14that will approximately result in the stimulation field defined by the clinician using the user interface.

FIG. 22is a flow diagram illustrating an example technique for defining a 3D stimulation field over an anatomical region without reference to an implanted lead. While user interface314does not provide a lead icon to the user when defining the stimulation field, other embodiments may provide the lead icon as a reference to the origination of stimulation therapy. As shown inFIG. 22, the clinician begins programming by selecting coronal view318(360) and outlining a 2D cross-section of the stimulation field in the coronal view (362). Next, the clinician selects sagittal view332(364) and outlines the 2D cross-section of the stimulation field in that view (366). The clinician continues to define the stimulation field by selecting axial view346(368) and outlining the 2D cross-section of the stimulation field in that view (370). The clinician instructs programmer19to automatically generate stimulation parameters corresponding to the 3D stimulation field defined by the 2D stimulation fields drawn in each of the three views, and the programmer transmits the parameters to IMD20(372).

The clinician delivers test stimulation with the generated stimulation parameters (374). If the clinician desires to adjust the stimulation therapy (376), the clinician repeats the process by selecting coronal view318(360). If the stimulation does not need to be adjusted, the clinician finalizes the stimulation therapy and sets IMD20to continue stimulation therapy (378).

In some embodiments, the clinician may continue to generate more stimulation fields to produce multiple stimulation programs for patient12to evaluate at home. Since programming may become easier than manually selecting parameters, using user interface314may allow the clinician to spend more time producing multiple therapy programs.

FIGS. 23-27are illustrative of another embodiment of this disclosure intended to allow physicians to define a stimulation field with respect to a lead icon within the anatomical region.FIG. 23is an example screen shot of an outline of a stimulation field placed around a lead icon on a coronal view of brain tissue. As shown inFIG. 23, user interface380is displayed on programmer382, which may be substantially similar to programmer19. User interface380includes coronal view384of brain18. Also shown on coronal view384are pointer394, lead icon396, stimulation field398, previous arrow386, next arrow388, menu390, and view indicator392. Stimulation field384is a cross-section of a volumetric stimulation field further defined in other sagittal and axial orthogonal views. Coronal view384is a 2D slice of a 3D image of brain18. White areas indicate dense neuronal tissue while dark areas indicate generally fluid filled area, where the fluid is CSF.

The clinician begins by examining the anatomical regions displayed in coronal view384. The clinician identifies the target anatomical regions that should be stimulated to treat patient12. In the example of Parkinson's disease, the clinician identifies the SN and other structures of brain18. The clinician moves pointer394to create an outline defining the outer edges of the stimulation field398. Lead icon396is a representation of lead14. Lead icon396location may be determined by the clinician moving the lead icon to the appropriate place according to the implantation in the manner discussed above. However, lead icon396may be automatically placed if the anatomical region is imaged with the lead implanted, as also discussed above.

The clinician uses pointer394to create the outline of stimulation field398, using lead icon396and the anatomical region as guidelines. The clinician may use lead icon396to define stimulation field398to correspond to the location of the electrodes of the lead icon. In this manner, the clinician may be able to stimulate the appropriate structures of the anatomical region and use desired electrode levels to do so. In some embodiments, lead icon396may only show the location of lead14and not provide the electrode level details of lead icon396.

The clinician may zoom in or out of an area of coronal view384. In addition, the clinician may move coronal view right, left, up or down to isolated areas of interest within the plane. Zoom may be of interest to the clinician when outlining the target anatomical region in order to fine tune the resulting stimulation field. Programmer80may set limit boundaries to the outline that the clinician may generate. These limit boundaries may be shown on coronal view384. In some embodiments, user interface380may allow the clinician to move up or down to view cross-section coronal views in other depths of brain18with arrows386and388. This movement through 2D slices may allow the clinician to identify each area of stimulation field398throughout the 3D stimulation field represented by user interface380.

The clinician may select menu390to perform any of the operations discussed above with respect to menus324,338, or352of user interface314. View indicator392allows the user to change to a different 2D view of the anatomical region, such as sagittal or axial views. “Coronal” is highlighted to indicate that the current view is a coronal section of brain18. Previous arrow386and next arrow388may allow the clinician to move between slices of adjacent depths of brain18and the stimulation field398in relation to the anatomical region of the other depths.

In some embodiments, user interface380may include a wand tool that the clinician can use to select an area. Then, all pixels of that same shade of color are outlined or highlighted. In this manner, the physician may select all anatomical regions of the same density which may be indicative of an entire target region. The clinician may define the range of pixels selected at one click. In addition, the clinician may manually modify the outlined area after using the wand tool.

The benefit to the clinician outlining desired areas includes allowing the clinician to focus on the anatomy and physiology of patient12instead of manipulating an implanted device. In other embodiments, user interface380may allow the clinician to use a stylus or finger on a touch screen to define the stimulation field and outline. In alternative embodiments, user interface380may identify and label certain anatomical regions to help guide the clinician in quickly orienting the stimulation field to brain18of patient12.

FIG. 24is an example screen shot of an outline of a stimulation field placed around a lead icon on a sagittal view of brain tissue. Since the defined stimulation field is three dimensional, the clinician must outline the stimulation field on three 2D views, rather than just the coronal view384ofFIG. 23. As shown inFIG. 24, the clinician uses pointer410to create stimulation field414around lead icon412within sagittal view400of user interface380. Stimulation field414encompasses the structures of the anatomical region that the clinician desires to stimulate and is a cross-section of the volumetric stimulation field defined by cross-sectional stimulation fields398and430in other orthogonal views. In some embodiments, programmer382may display a dotted line to indicate to the clinician where the previous cross-section stimulation field398was defined. In other embodiments, programmer382estimates the volumetric stimulation field from only one cross-section, e.g., stimulation field398, and presents the estimation to the clinician as stimulation field414which the clinician may alter as desired. Previous arrow402and next arrow404may be used to move within other slices of the sagittal place of the anatomical region, while menu406may be selected and used similar to menu390. View indicator408also highlights the word “Sagittal” to remind the clinician which plane of the anatomical region the clinician is viewing. Similar toFIG. 23, the clinician may zoom in and out of sagittal view400and move the view around the display. Additionally, the clinician may use a wand tool to select a range of pixel shades to quickly select anatomical regions that will be included in the stimulation field.

Similar toFIG. 23, lead icon412is a representation of lead14. Lead icon412location may be determined by the clinician moving the lead icon to the appropriate place according to the implantation. In addition, the clinician may rotate lead icon412to correctly position the lead icon within the anatomical region. However, lead icon396may be automatically placed if the anatomical region is imaged with the lead implanted.

FIG. 25is an example screen shot of an outline of a stimulation field placed around a lead icon on an axial view of brain tissue. As shown inFIG. 25, user interface380is provided by programmer382and includes axial view416that displays pointer426, stimulation field430, previous arrow418and next arrow420. Stimulation field430is a cross-section of the volumetric stimulation field defined in coronal and sagittal views384and400. User interface380also includes view indicator424. Similar to coronal view384and sagittal view400, the clinician uses pointer426to create an outline of stimulation field430around target structures of the anatomical region and lead icon428. Similar toFIGS. 23 and 24, lead icon428is placed in the correct position within the anatomical region according to the implanted lead14position. While lead icon428indicates that lead14is positioned orthogonal to axial view416, the actual position of lead14may be tilted.

The clinician may make adjustments to stimulation field430in axial view416or using previous arrow418and next arrow420to step up or down in axial slices of brain18. The clinician may also go back and forth between views384,400and416to make fine adjustments to the stimulation field defined by the one or more outlines in each of the three orthogonal views. Similar toFIGS. 23 and 24, the clinician may zoom in and out of axial view416, as well as move the view to the right, left, up and down of the anatomical region. The clinician may also use a wand tool to select similar pixels in the same area.

Once all stimulation fields398,414and430are complete, the clinician may have user interface380automatically generate stimulation parameters associated to the 3D stimulation field defined by stimulation fields398,414and430. The clinician may test the stimulation field on patient12and adjust the stimulation accordingly. Programmer382may provide limits to the shape and size of the outline from the clinician. In some embodiments, processor80may use stimulation templates to generate the stimulation parameters required to approximately reproduce the defined stimulation field, as described previously. In other embodiments, stimulation parameter equations may be used to determine the appropriate stimulation parameters that will satisfy the defined 3D stimulation field.

FIG. 26is an example screen shot of an outline of a stimulation field placed away from a lead icon on a sagittal view of brain tissue. As shown inFIG. 26, user interface380presents sagittal view432to the clinician with programmer382. Similar toFIG. 24, previous arrow434, next arrow436, menu438, and view indicator440are also provided to the clinician. Lead icon444represents the correct location of lead14implanted within patient12. Using pointer442, the clinician has outlined cross-sectional stimulation field446to cover the desired structures of the anatomical region. However, stimulation field446and the corresponding volumetric stimulation field does not overlap with any portion of lead icon444. Therefore, any stimulation therapy will affect tissue outside of stimulation field446between the stimulation field and implanted lead14. The clinician may be able to program the therapy in this manner, depending on the preferences stored within memory82of programmer382.FIG. 27indicates what may happen if a clinician creates a stimulation field such as stimulation field446.

FIG. 27is an example screen shot of a warning message regarding the best template set available for a stimulation field on a sagittal view of brain tissue. As shown inFIG. 27, user interface380provides sagittal view448on programmer382. In this embodiment, system10uses stimulation templates to automatically generate stimulation parameters according to the stimulation field. However, according toFIG. 26, the clinician has defined a stimulation field446that does not overlap with lead icon444. Therefore, warning box450is presented to the clinician. Warning box450indicates that the best fit stimulation template set will affect tissue of patient12that resides outside of the defined stimulation area446. The clinician may select cancel button452to remove stimulation field446and re-define a stimulation field. Alternatively, the clinician may select keep button454to disregard the warning and proceed with the currently defined stimulation area446.

In some embodiments, a similar message may be presented to the clinician without the use of stimulation templates, i.e., in embodiments in which stimulation parameters are automatically generated from the stimulation field defined by the clinician using any of the techniques described herein. In other embodiments, warning box450may provide a selection to the clinician that allows programmer382to suggest an alternative stimulation field that incorporates the currently selected stimulation field and areas adjacent to the lead. Warning box450may also be applied to user interface314ofFIGS. 19-21.

FIGS. 28-32illustrate user interfaces which provide 2D views of an anatomical region overlaid with a stimulation field and corresponding best fit stimulation template set.FIG. 28is an example screen shot of an outline of a stimulation field and corresponding template set on a coronal view of brain tissue. Programmer458presents coronal view460of an anatomical region of brain18to the clinician via user interface456. Programmer458may be substantially similar to programmer19. User interface456also includes previous arrow462, next arrow464, menu466, view indicator468, and voltage slider470. Lead icon474represents the location of lead14implanted within patient12. The clinician uses pointer472to define stimulation field476. Programmer458creates a stimulation template set478that best fits stimulation field496. Stimulation field476and stimulation template set478are each cross-sectional views of a volumetric stimulation field and a volumetric stimulation template, respectively. After the clinician has only defined one cross-section of the volumetric stimulation field, programmer458may estimate the volume and modify the estimation with further input from the clinician in other orthogonal views.

In the example ofFIGS. 28-30, stimulation template sets are selected by programmer458, e.g., processor80, to best fit the stimulation field, such as stimulation field476. Processor80is governed by instructions stored in memory82which may indicate that a stimulation template set should cover as much area within stimulation field476without affecting any area of the anatomical region outside of the stimulation field. In this manner, all portions of a desired structure may not be treated by the electrical stimulation. However, unwanted side effects that could occur from stimulation affecting areas outside of stimulation field476may be less likely. As discussed above, in other examples, processor80may be governed by instructions stored in memory82that define how the stimulation template set must correlate to the stimulation field. In some cases, the instructions may cause the processor to select a stimulation template set that covers as much of the stimulation field without covering tissue outside of the stimulation area. In other cases, the instructions may cause processor80to select a stimulation template set that at least covers all of the stimulation field.

Voltage slider470may be used by the clinician to increase or decrease the overall size of stimulation field476from the origin of lead icon474. Voltage slider470is an analog adjustment mechanism and may also be in the form of an adjustment knob instead of the slider. As the size of stimulation field476changes, the resulting best fit stimulation template set478may change, e.g., processor80may create a better fitting template set. In other embodiments, a new stimulation template set that fits the changes stimulation field476may only be provided if the user enters menu466to request programmer458try to identify a new stimulation template set. In addition, the clinician may view other coronal slices of the anatomical region by selecting previous button462or next button464that move to a different depth of the anatomical region. In some embodiments, programmer458may extrapolate stimulation field476and stimulation template478into other coronal slices of the anatomical regions if the clinician changes the slice. In other embodiments, lead icon474may be present in other slices, but stimulation field476, stimulation template468, or both, may not be present until the clinician defines the stimulation in at least one more orthogonal view so that programmer458can generate the volumetric stimulation field and template.

FIG. 29is an example screen shot of an outline of a stimulation field and corresponding template set on a sagittal view of brain tissue. As shown inFIG. 29, user interface456presents sagittal view480of an anatomical region of brain18to the clinician via programmer458. User interface456also includes previous arrow482, next arrow484, menu486, view indicator488, and voltage slider490. Lead icon494represents the location of lead14implanted within patient12. The clinician uses pointer492to outline and define stimulation field496. Stimulation field496is a cross-section of a volumetric stimulation field defined by multiple orthogonal views. Programmer458continues to display the sagittal view of template478if that template remains the best fit to stimulation field498. Otherwise, programmer458will generate a new stimulation template set that is a best fit for the volumetric stimulation field defined by stimulation fields476and496. In some embodiments, the clinician may reference stimulation field476from coronal view460by a dotted line indicating the orthogonal 2D stimulation field476. In other embodiments, stimulation field496may already be present in sagittal view480if programmer458estimates the volumetric stimulation field based upon the input inFIG. 28. In this case, the clinician may simply adjust the presented stimulation field to create stimulation field496as shown. These processes of defining the volumetric stimulation field may be used when viewing coronal, sagittal, and axial views in any order, not only the example order described herein.

The clinician may change the size of stimulation field496using voltage slider490. Voltage slider490is an analog adjustment mechanism and may also be in the form of an adjustment knob instead of the slider. The modified stimulation field496size may accommodate a different stimulation template set498that best fits the defined stimulation field. In addition, the clinician may move stimulation field496with pointer492to another location in sagittal view480. As inFIG. 28, the clinician may view different depth slices of the anatomical region by selecting previous arrow482or next arrow484.

FIG. 30is an example screen shot of an outline of a stimulation field and corresponding template set on an axial view of brain tissue. As shown inFIG. 29, user interface456presents axial view500of an anatomical region of brain18to the clinician via programmer458. User interface456also includes previous arrow502, next arrow504, menu506, view indicator508, and voltage slider510. Lead icon514represents the location of lead14implanted within patient12. Stimulation field516is already displayed on axial view500and is a cross-section of the volumetric stimulation field defined by stimulation fields476and496ofFIGS. 28 and 29, if they are defined first. However, the clinician may use pointer512to alter the shape or size of stimulation field516. Programmer458creates a stimulation template set518that best fits stimulation field516. In other embodiments, the clinician may have selected to begin defining the volumetric stimulation field in axial view500; therefore, there stimulation field516may not be already displayed on the axial view.

The clinician may change the size of stimulation field516using voltage slider510. Voltage slider510is an analog adjustment mechanism and may also be in the form of an adjustment knob instead of the slider. The modified stimulation field516size may accommodate a different stimulation template set518that best fits the defined stimulation field. In addition, the clinician may move stimulation field516with pointer512to another location in axial view500. As inFIG. 28, the clinician may view different depth slices of the anatomical region by selecting previous arrow502or next arrow504.

FIG. 31is an example screen shot of a menu window for template sets over a sagittal view of brain tissue. User interface456includes menu box524, which may be accessed from menu522, which may be substantially similar to any of menus466,486or506. Menus466,486and506have similar functionality, and are numbered differently to reflect that they are present in different views of user interface456. Menu box524provides options for the clinician such as accept button526, reposition button528, modify button530, and template button532. The clinician may select any of buttons526,528,530and532when the clinician desires that function. The clinician may also select exit button534to close menu box524. Alternative embodiments of menu button524may include more or less buttons that perform similar tasks related to programming the stimulation therapy.

FIG. 32is a flow diagram illustrating an example technique for creating a stimulation template set based upon received stimulation fields defined by the user. As shown inFIG. 32, user interface456begins by displaying the first default 2D view of the anatomical region, e.g., a coronal view, or the 2D view selected by the clinician (536). User interface456next receives the outline of a stimulation field from the clinician (538) and selects the best initial template set that fits the stimulation field currently defined by the clinician (540). User interface then displays the stimulation template set with the stimulation field in the selected 2D view (542). If the user selects another 2D view (544), user interface456displays the newly selected 2D view (536). After multiple stimulation fields have been defined in different orthogonal views, the volumetric stimulation field becomes more accurate to reflect the desired therapy of the clinician.

If the user does not select a different 2D view (544), user interface456will generate stimulation parameters according to the stimulation template set that best fits the stimulation field (546). Programmer458will transmit the stimulation parameters to IMD20and deliver test stimulation with the stimulation parameters (548). If the clinician desires to adjust the stimulation therapy (550), user interface will again display a selected or default 2D view of the anatomical region (536). If the clinician does not need to make any therapy adjustments, system10will finalize the stimulation therapy for chronic use (552).

In some embodiments, test stimulation may be provided to patient12in real time as the clinician defines new stimulation fields. This manner of testing therapy may take less time for the clinician to find an appropriate therapy. In other embodiments, programmer458may not need to generate stimulation parameters after the stimulation template set has been selected because the stimulation template set may already include stimulation parameters as needed by IMD20to provide the therapy.

FIGS. 33-38illustrate user interfaces that provide an atlas to a clinician for selecting structures of an anatomical region to stimulate.FIG. 33is an example screen shot of a coronal view of reference anatomy brain tissue to aid the user in selecting a structure of the anatomy to stimulate. As shown inFIG. 33, user interface554presents coronal view558of an atlas to the clinician via programmer556. Programmer556is an embodiment of programmer19. User interface554also includes previous arrow560, next arrow562, menu564, view indicator566, and structure box568. Pointer570is used by the clinician, or another user, to select a structure of the anatomical region represented in coronal view558to program stimulation therapy.

Coronal view558presents an atlas, where the atlas is a reference anatomical region of a reference anatomy. The atlas may be represented in the form of a drawing or actual image from an imaging modality such as magnetic resonance imaging (MRI), computer-aided tomography (CT), or other similar imaging technique. The reference anatomy may be an anatomy different from patient12anatomy. Specific structures of the reference anatomy may be identified and their locations within the reference anatomy determined to create an atlas. The atlas may be stored in memory82. While the atlas of coronal view558is mostly likely slightly different from the patient anatomical region of patient12anatomy, the structure locations may be close enough to generate stimulation parameters based upon the atlas. In this manner, the clinician may not need to recognize each structure of patient12. Instead, the clinician may only need to select the structure that is recognizable in the atlas. The clinician may use pointer570to select a specific structure of the atlas, at which time the structure name is displayed in structure box568. In the example ofFIG. 33, the substantia nigra has been identified in the atlas, and programmer556will map that structure of the atlas to the location of lead14in brain18.

User interface554may also allow the clinician to view other 2D sections of the atlas by using previous arrow560and next arrow562to move to other depths of the atlas. Since structures may be located throughout the volume of the 3D atlas, the clinician may need to move to other slices of the atlas to find a structure of interest. In some embodiments, user interface554may include a search input that allows the clinician to type in a structure name to move directly to the correct depth of the atlas.

Programmer556generates stimulation parameters based upon the location of the one or more selected structures to the location of lead14. In some embodiments, generating stimulation parameters may include selection of stimulation templates and creation of a stimulation template set based on the selected structures. In any case, the atlas allows the clinician to quickly select the most appropriate structure that needs to be stimulated to treat the condition of patient12.

FIG. 34is an example screen shot of a sagittal view of reference anatomy brain tissue to aid the user in selecting a structure of the anatomy to stimulate. As shown inFIG. 34, user interface554presents sagittal view572of an atlas to the clinician via programmer556. User interface554also includes previous arrow574, next arrow576, menu578, view indicator580, and structure box582. Pointer584is used by the clinician, or another user, to select a structure of the atlas represented in sagittal view572to program stimulation therapy, similar toFIG. 33.

Previous arrow574and next arrow576allow the clinician to move to other depths of the atlas for sagittal view572. Since structures may be located throughout the volume of the 3D atlas, the clinician may need to move to other slices of the atlas to find a structure of interest. In some embodiments, user interface554may include a search input that allows the clinician to type in a structure name to move directly to the correct depth of the atlas in the sagittal plane. In some embodiments, the clinician may not need to access sagittal view572because the desired structure may be found in coronal view558.

FIG. 35is an example screen shot of an axial view of reference anatomy brain tissue to aid the user in selecting a structure of the anatomy such that parameters for stimulation of patient12may be automatically determined based on the selected structure. As shown inFIG. 35, user interface554presents axial view586of an atlas to the clinician via programmer556. User interface554also includes previous arrow588, next arrow590, menu592, view indicator594, and structure box596. Pointer598is used by the clinician, or another user, to select a structure of the atlas represented in sagittal view572to program stimulation therapy, similar toFIGS. 33 and 34. In some embodiments, the clinician may not need to access axial view586because the desired structure may be found in coronal view558or sagittal view572.

Previous arrow588and next arrow590allow the clinician to move to other depths of the atlas for axial view586. Since structures may be located throughout the volume of the 3D atlas, the clinician may need to move to other slices of the atlas to find a structure of interest. In some embodiments, user interface554may include a search input that allows the clinician to type in a structure name to move directly to the correct depth of the atlas in the sagittal plane.

In some embodiments of user interface554, the user interface may highlight the selected one or more structures once the clinician has made the selection in the atlas. This graphical representation of the selected structures may allow the clinician to review the structures for accuracy in where stimulation therapy should occur. Alternatively, the atlas may show areas of atlas where stimulation therapy should be avoided to prevent unwanted side-effects. The highlighted structures may allow the clinician to make sure that no overlaps occur between the selected structures and areas where stimulation should be avoided.

FIG. 36is an example screen shot of a coronal view of reference anatomy brain tissue with the lead icon to aid the user in selecting a structure of the anatomy such that parameters for stimulation of patient12may be automatically determined based on the selected structure. As shown inFIG. 36, user interface600presents coronal view604of an atlas of to the clinician via programmer602. Programmer602is an embodiment of programmer19. User interface600also includes previous arrow606, next arrow608, menu610, view indicator612, and structure box614. Pointer616is used by the clinician, or another user, to select a structure of the anatomical region represented in coronal view604to program stimulation therapy.FIG. 36is substantially similar toFIG. 33, except that lead icon618is provided in user interface600to represent the implant location of lead14.

The clinician may place lead icon618into coronal view604of the atlas according to the implantation location within patient12. In alternative embodiments, system10may automatically enter the correct lead icon618location according to coordinates provided by the clinician, a surgeon, or an image of lead14within patient12. The clinician may prefer to use lead icon618location within the atlas as a reference location to select the appropriate structures. Based on the location of lead icon618and the selected structures within the atlas, programmer602may be able to automatically determine parameters for delivery of stimulation from lead14to patient12.

FIG. 37is an example screen shot of a sagittal view of reference anatomy brain tissue with the lead icon to aid the user in selecting a structure of the anatomy to stimulate. As shown inFIG. 37, user interface600presents sagittal view620of an atlas to the clinician via programmer602. User interface600also includes previous arrow622, next arrow624, menu626, view indicator628, and structure box630. Pointer632is used by the clinician, or another user, to select a structure of the atlas represented in sagittal view620to program stimulation therapy.FIG. 37is substantially similar toFIG. 34, except that lead icon634is provided in user interface600to represent the implant location of lead14for reference to the clinician. The clinician may adjust the location of lead icon634in coronal view620of the atlas according to the implantation location within patient12. Similar toFIG. 36, the clinician may prefer to use lead icon634location within the atlas as a reference location to select the appropriate structures for generating stimulation parameters.

FIG. 38is an example screen shot of an axial view of reference anatomy brain tissue with a lead icon to aid the user in selecting a structure of the anatomy to stimulate. As shown inFIG. 38, user interface600presents axial view636of an atlas to the clinician via programmer602. User interface600also includes previous arrow638, next arrow640, menu642, view indicator644, and structure box646. Pointer648is used by the clinician, or another user, to select a structure of the atlas represented in coronal view604or sagittal view620to program stimulation therapy, similar toFIG. 35.FIG. 38is substantially similar toFIG. 35, except that lead icon650is provided in user interface600to represent the implant location of lead14for reference to the clinician. The clinician may adjust the location of lead icon650in axial view636of the atlas according to the implantation location within patient12. Similar toFIG. 36, the clinician may prefer to use lead icon350location within the atlas as a reference location to select the appropriate structures for generating stimulation parameters.

FIGS. 39-41illustrate a user interface which includes an atlas overlaid with a patient anatomical region (shown in the examples via dotted lines and shading) that allows a clinician to select a structure for stimulation. In other embodiments, the atlas may be computer generated images while the patient anatomy is an actual CT image. Alternatively, both the atlas and patient anatomy are CT images or some other imaging modality which are separated by coloration, shading, or some other visual distinction. Furthermore, while not necessary, the clinician may be able to search different slices of each 2D view in order to locate specific anatomical structures in the atlas and patient anatomical region.FIG. 39is an example screen shot of a coronal view of reference anatomy brain tissue overlaid over a coronal view of the patient anatomy to aid the user in selecting a structure of the anatomy to stimulate. As shown inFIG. 39, programmer654presents coronal view656of an atlas670and a coronal view656of a patient anatomical region672to the clinician via user interface652. Programmer654may be substantially similar to programmer19. User interface652also includes previous arrow658, next arrow660, menu662, view indicator664, and structure box666. Pointer668is used by the clinician, or another user, to select a structure of atlas670represented in coronal view656to program stimulation therapy.FIG. 39is substantially similar toFIG. 33, except that patient anatomical region672is provided over atlas670to allow the clinician to view both the atlas and actual anatomy of patient12at the same time.

The clinician may select structures directly from the locations within atlas670. Patient anatomical region672is scaled to atlas670and provided to indicate to the clinician where the actual structure of patient12is located in relation to the atlas. In cases where atlas670closely mirrors the anatomy of patient12, overlaying patient anatomical region672may not be necessary for programming stimulation therapy. However, adding patient anatomical region672may be beneficial to the clinician in correctly treating patient12while avoiding problematic areas of brain18that may induce side-effects. Patient anatomical region672may be partially transparent so that atlas670may be readily viewable by the clinician or other user.

In some embodiments, user interface652may allow the clinician to toggle between viewing only atlas670or patient anatomical region672for clarity. Menu662may allow the clinician to select the transparency of patient anatomical region672according to their preference. In alternative embodiments, user interface may also present a lead icon in coronal view656, similar toFIG. 36. The lead icon may be placed within patient anatomical region672to accurately show the clinician from where stimulation therapy will be originating in patient12.

FIG. 40is an example screen shot of a sagittal view of reference anatomy brain tissue overlaid over a sagittal view of the patient anatomy to aid the user in selecting a structure of the patient anatomy to stimulate. As shown inFIG. 40, user interface652presents sagittal view674of an atlas688and a patient anatomical region690to the clinician via programmer654. User interface652also includes previous arrow676, next arrow679, menu680, view indicator682, and structure box684. Pointer686is used by the clinician, or another user, to select a structure of atlas688represented in sagittal view674to program stimulation therapy.FIG. 40is substantially similar toFIG. 34, except that patient anatomical region690is provided over atlas688to allow the clinician to view both the atlas and actual anatomy of patient12at the same time. As inFIG. 39, patient anatomical region690is at least partially transparent so that atlas688can be seen as well. The clinician may also use previous arrow676and next arrow678to move between slices at different depths than is shown in sagittal view674.

FIG. 41is an example screen shot of an axial view of reference anatomy brain tissue overlaid over an axial view of the patient anatomy to aid the user in selecting a structure of the patient anatomy to stimulate. As shown inFIG. 41, programmer654presents axial view690of an atlas704and a patient anatomical region706to the clinician via user interface652. User interface652also includes previous arrow692, next arrow694, menu696, view indicator698, and structure box700. Pointer702is used by the clinician, or another user, to select a structure of atlas704represented in axial view690to program stimulation therapy.FIG. 41is substantially similar toFIG. 35, except that patient anatomical region706is provided over atlas704to allow the clinician to view both the atlas and actual anatomy of patient12at the same time. As inFIG. 39, patient anatomical region706is at least partially transparent so that atlas704can be seen as well. The clinician may also use previous arrow692and next arrow694to move between slices at different depths than is shown in axial view690. Once the clinician is satisfied with the selected structures, the clinician can use menu696to request that programmer654generate stimulation parameters based upon the selected structures. In other embodiments, user interface652may provide a separate button to generate the stimulation parameters.

FIG. 42is a flow diagram illustrating an example technique for receiving stimulation input from a user using the reference anatomy, or atlas.FIG. 42may correspond to the process of programming the stimulation therapy illustrated in any examples ifFIGS. 33-41. However, user interface554ofFIGS. 33-35will be used as an example. The method begins when programmer556correlates the actual lead14position within patient12to the coordinates of the atlas (708). User interface556then presents the atlas to the clinician (710) and receives the structure selection from the clinician after the clinician has viewed the various 2D views of the atlas (712). Processor80of programmer558next generates stimulation parameters for the selected one or more structures in accordance with the location of lead14relative to the structures selected (714). Processor80also calculates an error for the stimulation therapy to the structures that are to be treated (716). Calculating the error may involve identifying the extent to which structures other than the selected structure must be stimulation in order for an IMD to deliver stimulation from lead to the selected structures. Processor80may calculate the error as a volume of extraneous tissue stimulated. Processor80may apply a weighting factor to the error based on the likelihood that stimulation of the particular extraneous tissue will result in side effects. If the error is greater than a predetermined threshold (718), user interface558prompts the clinician to select a new structure that may have a lower error (720). Then, user interface556again receives structure selection from the clinician (712).

If the error is smaller than the predetermined threshold, programmer558may store the stimulation parameters and initiate the transfer of the stimulation parameters to IMD20. Calculating the error may reduce the frequency and magnitude of side-effects that may be produced from stimulation therapy affecting non-target structures. In addition, calculating the error may reduce the number of ineffective stimulation parameters tried that do not fully treat the structure of concern. In either case, the error calculation may improve therapy efficacy and reduce clinician programming trial and error.

FIG. 43is an illustration that shows how the reference anatomy may be combined with the patient anatomy to result in a morphed atlas for programming the stimulation therapy. Atlas724is shown as a CT image while patient anatomical region726is illustrated as a computer model. In other embodiments, atlas724and patient anatomical region726may be any combination of CT images and/or computer models. As shown inFIG. 43, atlas724is a reference anatomical region of a reference anatomy. Atlas724is beneficial to use in programming stimulation therapy because the location of specific structures is know and readily identifiable. However, atlas724does not represent the actual anatomy of patient12surrounding implanted lead14. Patient anatomical region726represents the actual anatomy of patient12, but a clinician may not be able to easily identify the specific location of structures that should be subject to electrical stimulation.

To fit atlas724to patient anatomical region726, programmer19may essentially map the locations of structures of the atlas to the actual locations of the tissue of the patient anatomical region. This fitting may be completed by identifying specific markers common to all anatomies and fitting the remaining atlas724to the coordinates of patient anatomical region726. This resulting morphed atlas728may allow a clinician to select structures at the specific location in question. One example of how programmer19may create morphed atlas728is described in U.S. Patent Application No. 2005/0070781 by Dawant et al., entitled, “ELECTROPHYSIOLOGICAL ATLAS AND APPLICATIONS OF SAME” and filed Jul. 1, 2004.FIGS. 44-47illustrate the use of morphed atlas728for programming stimulation therapy.

Morphed atlas728may provide some advantages to the clinician over atlas724or patient anatomical region726alone. For example, the clinician may be able to define a stimulation field on morphed atlas728and review that the desire structure resides within the volumetric stimulation field. Alternatively, the clinician may request a particular structure, and morphed atlas728may point the clinician directly to the corresponding location of the patient anatomy.

FIG. 44is an example screen shot of a coronal view of a morphed atlas to aid the user in selecting a structure of the anatomy to stimulate. As shown inFIG. 44, user interface730presents coronal view734of morphed atlas728to the clinician via programmer732. Programmer732is an embodiment of programmer19. User interface730also includes previous arrow736, next arrow738, menu740, view indicator742, and structure box744. Lead icon748represents the location of lead14in patient12. Pointer746is used by the clinician, or another user, to select a structure of coronal view734of morphed atlas728to program stimulation therapy. The clinician may select any structure by pointing to a location of coronal view734, and the specific structure is then listed in structure box744.

Other 2D slices of morphed atlas728at different depths may be viewed by the clinician via selecting previous arrow736or next arrow738. Programmer732generates stimulation parameters based upon the one or more selected structures from coronal view734of morphed atlas728and the location of the structures to the location of lead14represented by lead icon748. In some embodiments, generating stimulation parameters may include the use of stimulation templates and creating a stimulation template set according to the selected structures. In any case, the morphed atlas allows the clinician to quickly select the most appropriate structure that needs to be stimulated to treat the condition of patient12.

FIG. 45is an example screen shot of a sagittal view of a morphed atlas to aid the user in selecting a structure of the anatomy to stimulate. As shown inFIG. 45, user interface730presents sagittal view750of morphed atlas728to the clinician via programmer732. User interface730also includes previous arrow752, next arrow754, menu756, view indicator758, and structure box760. Lead icon764represents the location of lead14in patient12. Pointer762is used by the clinician, or another user, to select a structure of sagittal view750of morphed atlas728to program stimulation therapy. The clinician may select any structure by pointing to a location of sagittal view750, and the specific structure is then listed in structure box760. Similar toFIG. 44, the clinician may go to other depths of morphed atlas728by using previous arrow752and next arrow754. The clinician may also move lead icon764to correctly position the lead icon based on the location of lead14, if adjustments are necessary.

FIG. 46is an example screen shot of an axial view of a morphed atlas to aid the user in selecting a structure of the anatomy to stimulate. As shown inFIG. 46, user interface730presents axial view766of morphed atlas728to the clinician via programmer732. User interface730also includes previous arrow768, next arrow770, menu772, view indicator774, and structure box776. Lead icon780represents the location of lead14in patient12. Pointer778is used by the clinician, or another user, to select a structure of axial view766of morphed atlas728to program stimulation therapy. The clinician may select any structure by pointing to a location of axial view766, and the specific structure is then listed in structure box776. Similar toFIG. 44, the clinician may go to other depths of morphed atlas728by using previous arrow768and next arrow770. The clinician may also move lead icon780to correctly position the lead icon to lead14, if adjustments are necessary. The clinician may also use view indicator774to switch between coronal view734, sagittal view750, and axial view766. Menu772may be used to request that programmer732generate stimulation parameters to fit the structures that are selected from morphed atlas728.

FIG. 47is a flow diagram illustrating an example technique for creating the morphed atlas and receiving a structure selection from the user. As shown inFIG. 47, programmer732begins by creating an atlas coordinate system (ACS) which includes structures defined within the ACS (782). Next programmer732creates a patient data coordinate system (PCS) according to the stored patient anatomy data (784). Programmer732scales the sizes of the ACS to the size of the PCS before any other operation takes place (786). Programmer then can fit, or morph, the ACS to the PCS in order to create the morphed atlas728(788). In addition, programmer732determines the lead14location within morphed atlas728based on its position in the patient anatomy so that the programmer can generate appropriate stimulation parameters (790). User interface730can then present 2D views of morphed atlas728as needed to the clinician (792). When prompted by the clinician, user interface730receives structure selection from the clinician (794) and generates the appropriate stimulation parameters from the selected structures associated with morphed atlas728(796).

In some embodiments, programmer732may use stimulation templates in order to generate stimulation parameters for therapy. Alternatively, programmer732may use a set of stimulation equations that can handle structure coordinates from the morphed atlas to produce stimulation parameter sets. In other embodiments, morphed atlas732may need to be generated by a stand alone workstation with sufficient processing power. Programmer732embodied as a hand held computing device may not be capable of generating the morphed atlas in an appropriate time frame. It should be mentioned that other methods of producing the morphed atlas from the original atlas and patient anatomy may be used and remain within the scope of this disclosure.

FIG. 48is an example user interface that allows the user to select structures to stimulate from multiple pull down menus. As shown inFIG. 48, the clinician may utilize user interface798to select structures that should be stimulated by IMD20. Alternatively, the clinician may determine “keepout” regions by selection of one or more structures to prevent or avoid electrical stimulation of those selected regions. Programmer800may be substantially similar to programmer19. Programmer800displays structure view802to a clinician which includes structure menus806,812and818. Structure view802also includes previous arrow824, next arrow826, menu828, accept button830, add button832, reset button834and map button836. Structure menus806,812and818may be considered “drop-down menus,” although other means for selecting structures, such as text boxes that allow the clinician to enter text of the structure to stimulate, may be used in alternative embodiments. User interface798is an alternative to providing the clinician with a graphical representation of an atlas as illustrated in user interface554.

A user, such as the clinician, uses pointer804to select arrow808to open structure menu806in which provides multiple structures by name to the clinician. The clinician can then select one of the structures from structure menu806as the first structure that is to be stimulated. The clinician may also define the magnitude of the stimulation therapy to the selected first structure. Power value810allows the clinician to set a percentage of the default stimulation for that structure. For example, if the clinician desires to only stimulate part of the first structure, the clinician may set power value810to 50% so that the entire structure is not subject to the electrical stimulation.

The user may also select more structures to be stimulated. The user may select a second structure from structure menu812using arrow808and a third structure from structure menu818using arrow820. Although illustrated as three, any number of structures may be selected. Similar to the first structure, the clinician may use power values816and822to specific the stimulation magnitude for each respective structure. User interface798may provide more structure menus to the clinician by including a scroll option in structure view802. The clinician may select add button832to add another structure menu. Alternatively, user interface798may require the clinician to enter another screen to view additional structure menus. In other embodiments, user interface798may only provide structures that are physically capable of being stimulated by lead14based upon the lead location and IMD20capabilities.

Once the clinician has finished selecting the one or more structures for stimulation, the clinician may select accept button830. Once accept button830is selected, programmer800may generate the best stimulation parameters according to the selected structures. If the clinician desires to change the structures, the clinician may select reset button834to return each structure menu806,812and818to its default setting of “none.” In addition, the clinician may desire to visualize the selected structures on the atlas or morphed atlas. Once the clinician selects map button836, structure view802may be replaced by a graphical representation of an atlas similar to any of views558,572or586of user interface554. Alternatively, any of user interfaces600,652or730may be used to visualize the structures to the clinician after the selection of map button836.

FIG. 49is an example user interface that shows a pull down menu ofFIG. 48which contains anatomical structures that the user may select to program the stimulation therapy. As shown inFIG. 49, structure view838displays that the clinician has selected arrow844of structure menu842to view the available structures to stimulate in list846. Scroll bar848may be used to view all structures of list846. Using pointer840, the clinician is about to select “SUBSTANTIA NIGRA” as the first structure to be stimulated. Once selected, list846disappears to allow the clinician to select a second structure if desired. The structures of list846are merely exemplary, and may depend upon the anatomical region of interest or allowable stimulated structures of brain18.

FIG. 50is an example illustration of a coronal view of an atlas with structure menu858which contains anatomical structures that the user may select to program the stimulation therapy. As shown inFIG. 50, user interface850presents structure menu858over coronal view854of an atlas, similar toFIG. 36, of to the clinician via programmer852. Programmer852is an embodiment of programmer19. User interface850also includes previous arrow864, next arrow866, menu868, view indicator870, amplitude slide874, and structure button872.

Once the clinician selects structure button872, structure menu858may pop up over the atlas to allow the clinician to easily select the structure of interest. Pointer856is used by the clinician, or another user, to select arrow856and view list860. Scroll bar862may allow the clinician to view all structures within list860. Once the clinician selects the desired structure from list860, the selected structure may then be added to the structures for stimulation. In some embodiments, the selected structure may be highlighted, shaded, or colored for easy identification in coronal view854. Structure menu858may be substantially similar to a structure menu842ofFIG. 49, except that structure menu858is displayed over an atlas. In alternative embodiments, user interface850may include structure menu858over any views of user interfaces554,600,652or730.

FIG. 51is an example screen shot of a coronal view of a morphed atlas that indicates which structure the user has pointed to with a pop-up message. As shown inFIG. 51, user interface876is an embodiment of any of user interfaces554,600,652or730. However, user interface876uses morphed atlas728of user interface730as an example. User interface876provides coronal view880on programmer878. Programmer878is an embodiment of programmer19. User interface876also presents previous arrow886, next arrow888, menu890, view indicator892, structure box894and labels button896. As the clinician moves pointer882over coronal view880, pop-up884will appear and indicate which structure pointer882would select if the clinician selects that area of morphed atlas728. Pop-up884may be turned off by selecting labels button896.

FIG. 52is flow diagram illustrating an example technique for receiving a structure selection from a user and displaying the structure to the user. The method ofFIG. 52may be used with any of user interfaces798,850or876; however, the method is described with reference to structure menus of user interface798. Programmer800is used as an example inFIG. 52, but any of programmers800,852, or878may be used. Programmer800provides a structure menu, e.g., a drop down menu, to a clinician (898). User interface798next receives one or more structure selections from the clinician (900). Once prompted, programmer800generates stimulation parameters for the one or more selected structures (902). Programmer800will next calculate an error based upon the stimulation that will be delivered from lead14to the selected structures (904). If the error is greater than a predetermined threshold (906), programmer800will prompt the clinician to select a new structure that will produce a lesser error (908). Programmer800will then proceed to receive new structure selection from the clinician (900). If the error is less than the predetermined threshold (906), user interface798will determine if the structure should be displayed on the atlas (910). If the structure is not to be displayed, programmer800will store the generated stimulation parameters and transmit the parameters to IMD20for therapy (914). If the structure is to be presented on the atlas to the clinician, processor800controls user interface798will display the atlas and structure to the clinician (912) prior to storing the stimulation parameters and transmitting the parameters to IMD20.

FIGS. 53-57illustrate an electrical field model that is displayed to a user in orthogonal 2D views to approximate actual stimulation effects from therapy.FIG. 53is an example screen shot of a coronal view of a patient anatomy with an electrical field model of the defined stimulation therapy. As shown inFIG. 53, programmer918controls user interface916to display coronal view920. Programmer918may be substantially similar to programmer19, and coronal view920may be a 2D view of any one of an atlas, a morphed atlas, or a patient anatomical region as described herein. User interface916also includes previous arrow922, next arrow924, menu926, view indicator928, and amplitude932with slider934. The clinician interacts with user interface916using pointer930.

Programmer918controls user interface916to display lead icon936and electrical field938to illustrate to the clinician what the electrical field of the stimulation therapy would look like according to the stimulation parameters defined by the clinician using any of the programming techniques described herein. Electrical field938represents where the electrical current will propagate from lead14within brain18, as tissue variation within brain18may change the electrical current propagation from the lead. The variations in electrical field propagation may affect the ability of the therapy to actually treat a desired structure or cause a side-effect.

Electrical field938is a 2D slice of the volumetric electrical field model created by programmer918. Programmer918utilizes the patient anatomical region data with electrical field model equations that define current propagation. In this manner, electrical field938can be estimated and modeled for the clinician. Accordingly, the clinician may be able to increase or decrease the amplitude of the stimulation parameters with slider934and view how the amplitude change would affect the size and shape of electrical field938. Slider934is an analog adjustment mechanism and may also be in the form of an adjustment knob instead of the slider. The clinician may move to other depths of brain18by selecting previous arrow922or next arrow924and continue to view electrical field938and the surrounding anatomical region. In some embodiments, user interface916may allow the clinician to redefine the stimulation field and generate new stimulation parameters if electrical field938is not acceptable for therapy.

FIG. 54is an example screen shot of a sagittal view of a patient anatomy with an electrical field model of the defined stimulation therapy. As shown inFIG. 54, programmer918controls user interface916to display sagittal view940to a clinician. Similar toFIG. 53, sagittal view940may be a 2D view of any one of an atlas, a morphed atlas, or a patient anatomical region as described herein. User interface916also includes previous arrow942, next arrow944, menu946, view indicator948, and amplitude933with slider935. The clinician interacts with user interface916using pointer931. Similar toFIG. 53, electrical field939provides a model of the actual electrical stimulation around lead icon937according to the generated stimulation parameters for therapy. The clinician may move to different depths of sagittal view940with previous arrow942or next arrow944while adjusting the amplitude of electrical field939with slider935. Slider935is an analog adjustment mechanism and may also be in the form of an adjustment knob instead of the slider.

FIG. 55is an example screen shot of an axial view of a patient anatomy with an electrical field model of the defined stimulation therapy. As shown inFIG. 55, user interface916displays axial view941to a clinician via control from programmer918. Similar toFIG. 53, axial view941may be a 2D view of any one of an atlas, a morphed atlas, or a patient anatomical region as described herein. User interface916also includes previous arrow943, next arrow945, menu947, view indicator949, and amplitude953with slider955. The clinician interacts with user interface916using pointer951. Similar toFIG. 53, electrical field959provides a model of the actual electrical stimulation around lead icon957according to the generated stimulation parameters for therapy. The clinician may move to different depths of axial view941with previous arrow943or next arrow945while adjusting the amplitude of electrical field959with slider955. Similar to slider935, slider955is an analog adjustment mechanism and may also be in the form of an adjustment knob instead of the slider. When the clinician is finished viewing the electrical field model, the clinician may select menu947to either reprogram the stimulation therapy or deliver therapy with the current stimulation parameters.

FIG. 56is an example screen shot of an axial view of a patient anatomy with an electrical field model of the enlarged defined stimulation therapy fromFIG. 55.FIG. 56includes user interface916that displays axial view961, lead icon969and electrical field971. The clinician has used pointer963to move slide967towards greater amplitude to increase the size of electrical field971as compared to electrical field959ofFIG. 55. Not only does the size of electrical field971increase, but the shape of the electrical field changes as well because of the electrical propagation through the anatomical region. Alternatively, the clinician may grab electrical field950to make it bigger, which moves slide967towards greater amplitude. It should be noted that increasing the current or voltage amplitude of electrical field971will increase power consumption from power source78of simulator20. In some embodiments, user interface916may include a power consumption indicator that displays therapy duration with proposed power consumption, rate of power consumption, or some other indicator that the clinician can use to program the stimulation therapy.

FIG. 57is a flow diagram illustrating an example technique for calculating and displaying the electrical field model of defined stimulation described with reference to the examples ofFIGS. 54-56. As shown inFIG. 57, programmer918receives patient anatomy data necessary for creating an electrical field (952). Programmer918enters the patient anatomy data in stored electrical field model equations or equation sets to satisfy anatomical variable (954). Programmer918next calculates the electrical field model from the data and equations (956). Once user interface916receives stimulation input from the clinician defining the stimulation field (958), programmer918generates the electrical field that is displayed to the clinician via the user interface (960). If the clinician desires to change the stimulation input (962), user interface916receives a change in the stimulation input and programmer918makes the corresponding changes (958). If the clinician does not request a stimulation input change (962), user interface916continues to display the electrical field to the clinician according to programmer918(960).

FIGS. 58-62illustrate an activation field model that is presented to a user.FIG. 58is an example screen shot of a coronal view of a patient anatomy with an activation field model of the defined stimulation therapy. As shown inFIG. 58, user interface964includes a programmer that displays coronal view968to a clinician. Programmer966may be substantially similar to programmer19, and coronal view968may be a 2D view of any one of an atlas, a morphed atlas, or a patient anatomical region as described herein. Coronal view968also includes previous arrow970, next arrow972, menu947, view indicator976, and amplitude980with slider982. The clinician interacts with programmer966using pointer978.

Programmer966displays lead icon984and activation fields986,988and990on coronal view968to illustrate to the clinician which neurons in the anatomical region will be activated by the produced electrical field. An activation field model is generated by applying a neuron model to a generated electrical field model. The neuron model indicates the voltage or current amplitude that is required for the tissue within the anatomical region to be stimulated. Since some tissue may be covered by an electrical field of voltage too small to activate the neurons in that tissue, this tissue is not actually affected by the electrical field. The activation field model may accurately indicate which tissues will be treated by the electrical field. As shown in coronal view968, the activation field model is not continuous. Due to some tissue not activated by the electrical field, the activation field model is broken into activation fields986,988and990.

Activation fields986,988and990are 2D slices of the volumetric activation field model created by programmer966. Programmer966utilizes the patient anatomical region data with electrical field model equations to define an electrical field model. A neuron model is applied to the electrical field model to create the activation field model shown inFIG. 58. Accordingly, the clinician may be able to increase or decrease the amplitude of the stimulation parameters with slider982, or analog adjustment mechanism, in view how the amplitude change would affect the size and shape of activation fields986,988and990. Changing the amplitude of the stimulation may change the number of activation fields as different numbers of neurons in the tissue are activated. The clinician may move to other depths of brain18by selecting previous arrow970or next arrow972and continue to view 2D slices of the activation field model and the surrounding anatomical region. In some embodiments, programmer966may allow the clinician to redefine the stimulation field and generate new stimulation parameters if activation fields986,988and990is not acceptable for therapy.

FIG. 59is an example screen shot of a sagittal view of a patient anatomy with an activation field model of the defined stimulation therapy. As shown inFIG. 59, user interface964includes a programmer966that displays sagittal view992to a clinician. Similar toFIG. 58, sagittal view992may be a 2D view of any one of an atlas, a morphed atlas, or a patient anatomical region as described herein. Sagittal view992also includes previous arrow994, next arrow996, menu998, view indicator1000, and amplitude1004with slider1006. The clinician interacts with programmer966using pointer1002. Similar toFIG. 58, activation fields1010and1012provide a model of the actual neurons that are activated around lead icon1008according to the generated stimulation parameters for therapy. The clinician may move to different depths of sagittal view992with previous arrow994or next arrow996while adjusting the amplitude of the activation field model with slider1006, e.g., an analog adjustment mechanism.

FIG. 60is an example screen shot of an axial view of a patient anatomy with an activation field model of the defined stimulation therapy. As shown inFIG. 60, user interface964includes programmer966that displays axial view1014to a clinician. Similar toFIG. 58, axial view1014may be a 2D view of any one of an atlas, a morphed atlas, or a patient anatomical region as described herein. Axial view1014also includes previous arrow1016, next arrow1018, menu1020, view indicator1022, and amplitude1026with slider1028. The clinician interacts with user interface964using pointer1024. Similar toFIG. 58, activation fields1032,1034,1036and1038provide a model of the actual neurons that are activated around lead icon1030according to the generated stimulation parameters for therapy. The clinician may move to different depths of axial view1014with previous arrow1016or next arrow1018while adjusting the amplitude of the activation field model with slider1028, e.g., an analog adjustment mechanism. When the clinician is finished viewing the activation field model of user interface964, the clinician may select menu1020to either reprogram the stimulation therapy or deliver therapy with the current stimulation parameters.

FIG. 61is an example screen shot of an axial view of a patient anatomy with an activation field model of the enlarged defined stimulation therapy fromFIG. 60.FIG. 61includes user interface964that displays axial view1040(similar to axial view1014) lead icon1048and activation fields1050,1052,1054and1056of the full activation field model. The clinician has used pointer1042to move slide1046towards greater amplitude to increase the size of the activation field model, which is shown by new activation fields1050,1052,1054and1056as compared to electrical fields1032,1034,1036and1038ofFIG. 60. Not only does the size of the activation fields increase, but the shape and location of the activation fields change because the increased amplitude of the electrical field changes the tissues that are activated from the stimulation. Alternatively, the clinician may grab any of activation fields1050-1056to make it bigger, which moves slide1046towards greater amplitude. It should be noted that increasing the current or voltage amplitude of electrical field971, and the corresponding activation fields, will increase power consumption from power source78of simulator20. In some embodiments, user interface964may include a power consumption indicator that displays therapy duration with proposed power consumption, rate of power consumption, or some other indicator that the clinician can use to program the stimulation therapy.

FIG. 62is a flow diagram illustrating an example technique for calculating and displaying the activation field model of defined stimulation. As shown inFIG. 62, programmer966receives patient anatomy data through user interface964indicative of the anatomy of patient12(1058) and the programmer calculates the electrical field model from the patient anatomy data (1060). Programmer966then retrieves the neuron model and fits the neuron model to the electrical field (1062). Programmer966then calculates the activation field model based upon the electrical field model and neuron model (1064). Programmer966is then is able to receive stimulation input through user interface964from the clinician defining what structures of the anatomical region should be stimulated (1066). The resulting activation field model is displayed by user interface964(1068). If the clinician desires to change the stimulation input (1070), user interface964receives stimulation input from the clinician modifying the previous stimulation input (1066). If the stimulation input does not need to be changed (1070), the activation field model continues to be displayed by programmer966(1068).

FIGS. 63-66are related to an embodiment of the disclosure allowing a user to define a stimulation field in a 3D environment.FIG. 63is a conceptual diagram illustrating a 3D visualization environment including a 3D brain model for defining a 3D stimulation field.FIG. 63is a conceptual diagram illustrating a three-dimensional (3D) environment including a 3D brain model for defining a 3D stimulation field. As shown inFIG. 63, user interface1072includes 3D view1074, brain model1076, stimulation field1078, and hand1080. 3D view1074is a 3D environment for the clinician to program IMD20. Brain model1076is a 3D anatomical region and stimulation field1078is a 3D stimulation field within brain model1076. Hand1080controls the view and aspects of 3D view according to user input from the clinician. Generally, brain model1076is stationed showing a sagittal view.

3D view1074may be displayed on a hand held programmer, which may include components similar to those illustrated with reference to programmer19inFIG. 5, or rendered in a 3D virtual reality space provided by a computing device that shows depth with any type of 3D display. 3D view1074can be displayed on a 2D display by using partially transparent surfaces and grey or color shades. A fully interactive 3D view1074may allow a clinician to view within brain model1076and identify anatomical regions that are targets for stimulation therapy. User interface1072may even include a glove or finger device that is the input mechanism for rotating and adjusting 3D view1074. Brain model1076may be generated from imaging data from MRI, CT, or other imaging modality. While shading of brain model1076are not shown inFIGS. 63-65, the clinician would see anatomical regions of brain18.

While a lead icon representing lead14is not shown in 3D view1074, user interface1072may incorporate imaging data after lead14is implanted to automatically recognize the orientation and location of the lead within patient12. Alternatively, the clinician may place a lead icon within brain model1076based upon stereotactic data or implant coordinates.

User interface1072initially displays stimulation field1078based upon the location of lead14. The clinician can adjust and manipulate stimulation field1078as desired with hand1080. The clinician may also use hand1080to rotate and spin brain model1076in any direction. User interface1072also supports zooming in and out and “flying” around 3D view1074to see stimulation field1078within brain model1076.

User interface1072may include a wand tool that allows the clinician to highlight various ranges in brain model1076to be included in stimulation field1078. The wand tool may automatically select pixels in all three dimensions. In other dimensions, the clinician may grab one of several predefined stimulation field shapes and place the shape within brain model1076to become stimulation field1078. In any case, user interface1072may set limits to stimulation field1078based upon the characteristics of lead14and the capabilities of IMD20. Patient12safety may also govern the size and location of stimulation field1078.

FIG. 64is a conceptual diagram illustrating a rotated 3D brain model with the currently defined 3D stimulation field. As shown inFIG. 64, user interface1072includes 3D view1074, brain model1082, stimulation field1084and hand1086. The clinician has grabbed brain model1082with hand1086to rotate the brain model to show a coronal view from the front of the brain. 3D view1074also shows that stimulation field1084is located in the left hemisphere of brain18. The clinician may move or adjust stimulation field1084to cover target anatomical regions and avoid adjacent regions not to be stimulated.

FIG. 65is a conceptual diagram illustrating a manipulated 3D stimulation field positioned within a 3D brain model.FIG. 65is a conceptual diagram illustrating a manipulated 3D stimulation field positioned within 3D brain model1088. As shown inFIG. 65, the clinician has stretched the shape of stimulation field1090with hand1092. The clinician may continue to stretch and mold the shape of stimulation field1090until the stimulation field covers the anatomical regions targeted for electrical stimulation. The clinician may zoom in to have greater fine control over the shape of stimulation field1090.

The clinician may also use user interface1072to add additional stimulation fields, shrink stimulation fields, or split a stimulation field into two stimulation fields. In some embodiments, certain areas of brain18may be blocked from stimulation. User interface1072may automatically eliminate stimulation from those areas without the clinician needing to match the outline of the blocked areas. Once the clinician is completed with adjusting stimulation field1088, user interface1072may utilize programmer19to generate the associated stimulation parameters.

User interface1072may be very intuitive and even instructional to clinicians needing to program IMD20with a 3D lead such as lead14. Programming mechanisms similar to this may help a greater number of patients receive the full benefits from stimulation therapy by avoiding some of the less than ideal therapies resulting from manual electrode programming and the lengthy times associated with manual programming.

In some embodiments, user interface1072may allow the clinician to locate the correct placement of the lead icon representation of lead14within 3D brain model1088and continue defining a stimulation field in 2D orthogonal views such as the ones described in user interface90. Since the central axis of the lead icon may not lie completely within, e.g., be parallel to, the plane of a preset coronal view92, sagittal view102, or axial view102, 3D brain model1088may allow the clinician to easily identify an oblique plane (oblique view) that is substantially parallel with the central axis of the lead icon. The clinician may then lock this oblique view and use the oblique view and other orthogonal planes of the oblique view to define a stimulation field, similar to user interface90. In addition, user interface1072may automatically identify an oblique plane that includes the lead icon and allow the clinician to rotate the oblique plane around the lead icon until the clinician creates the desired oblique view. The clinician may then use this oblique view to continue programming using 2D views.

FIG. 66is a flow diagram illustrating an example technique for defining a 3D stimulation field within a 3D brain model of the patient.FIG. 66is a flow diagram illustrating an exemplary technique for defining a 3D stimulation field within a 3D brain model of the patient. As shown inFIG. 66, the clinician implants lead14according to the technique shown inFIG. 11(1094). The clinician then images the head of patient12to generate the needed data of brain18(1096). The clinician uploads the image data to programmer19(1098) and the programmer generates the 3D environment (1100). Programmer19generates brain model1076and the initial stimulation field1078(1102).

Programmer19receives stimulation field input from a clinician via user interface1072to adjust and manipulate stimulation field1078(1104). Programmer19generates stimulation parameters according to stimulation field1078(1106) and IMD20delivers test stimulation with the parameters (1110). If the clinician desires to adjust stimulation (1108), programmer19again receives stimulation field input (1104). If the stimulation therapy is effective, the clinician saves the stimulation parameters in IMD20so that patient12can receive therapy with the parameters (1112).

FIGS. 67-70illustrate a 3D environment for defining a 3D stimulation field with stimulation templates.FIG. 67is a conceptual diagram illustrating a 3D visualization environment that facilitates programming with a stimulation template set. As shown inFIG. 67, user interface1114presents 3D environment1116to the clinician which allows the clinician to define 3D stimulation field1122within 3D brain model1120. User interface1114may be provided by a programmer substantially similar to programmer19, or another computing device. User interface1114may be similar to user interface1072ofFIG. 63. However, user interface1114is directed to creating a stimulation template set from 3D stimulation field1122. 3D brain model1120is an anatomical region of the patient anatomy and is represented with shading, colors, or some other mechanism of representing the brain18in three dimensions to the clinician. The clinician uses hand1118to grasp 3D stimulation field1122and change the stimulation field shape and size. In some embodiments, user interface1114may allow the clinician to split 3D stimulation field1122into more than one continuous region. In other embodiments, user interface1114may provide a lead icon that represents lead14implanted within patient12.

FIG. 68is a conceptual diagram illustrating a three-dimensional (3D) visualization environment including a 3D brain model and the template set created based on the defined 3D stimulation field. As shown inFIG. 68, user interface1114displays 3D brain model1126in 3D environment1116, similar toFIG. 67. Within 3D brain model1126is 3D stimulation field1128and corresponding stimulation template set1130. Hand1124may still be used to alter the shape, size, and location of 3D stimulation field1128. User interface1114may change stimulation template set1130to match and 3D stimulation field1128changes, e.g., by adding, removing or replacing stimulation templates from the template sets. The clinician may also use hand1124to rotate, zoom in, zoom out, and view 3D brain model1126from different angles and perspectives to identify the actual structures of brain18that stimulation template set1130would affect during therapy.

Stimulation template set1130may be created from one or more stimulation templates that relate to each electrode of lead14. Stimulation template set1130may be created in a similar manner as described inFIGS. 28-32. The volumetric stimulation templates that are a best fit to stimulation field1128may be combined to create the volumetric stimulation template set1130. 3D environment1116allows the clinician to view the entire stimulation template set1130and tissue structures simultaneously to review the suggested stimulation therapy for patient12.

FIG. 69is substantially similar toFIG. 68. User interface1114displays 3D brain model1134in 3D environment1116. Within 3D brain model1134is 3D stimulation field1136and corresponding stimulation template set1138. Hand1132may still be used to alter the shape, size, and location of 3D stimulation field1128. In addition, lead icon1140is provided within 3D brain model1134to allow the clinician to view the proposed stimulation template set1138in relation to electrodes of lead14implanted within patient12. As shown inFIG. 69, stimulation template set1138surrounds lead icon1140in a cylindrical type formation. However, any other stimulation template set supported by system10may be used to attempt to match 3D stimulation field1136.

FIG. 70is a flow diagram illustrating an example technique for creating a template set and displaying the template set in a 3D brain model of the patient. As shown inFIG. 70, user interface1114displays 3D brain model1126in 3D environment1116(1142). User interface1114next receives stimulation field input from the clinician (1144). Processor80calculates the error between the stimulation field and the available stimulation templates, e.g., based on a comparison of their volumes (1146). From the error calculations, processor80selects the stimulation template set with the smallest error between the templates and the stimulation field (1148). Typically, the template set must remain within the defined stimulation area to prevent stimulation of non-target tissue. However, some embodiments, may allow stimulation template sets that best fit the stimulation area even when a portion of the stimulation template set stimulates tissue outside of the stimulation field.

If the best fit stimulation template set error is greater than a predetermined threshold (1150), user interface1114will provide the stimulation template set to the clinician with an error message indicating that the template set exceeds the error threshold (1152). If the best fit stimulation template set error is less than the predetermined threshold (1150), user interface1114provides the stimulation template set to the clinician (1154). If the clinician does not accept the created stimulation template set (1156), user interface1114will again receive stimulation field input (1144). If the clinician wants to accept the stimulation template set for therapy (1156), programmer19stores the stimulation parameters from the stimulation template set (1158). Programmer19then delivers the stimulation parameter sets to IMD20which delivers the stimulation therapy to patient12(1160).

FIGS. 71-73illustrate example electrical field models that show a user which structures of brain18will be covered by the electrical field resulting from delivery of stimulation.FIG. 71is a conceptual diagram illustrating a three-dimensional (3D) visualization environment including a 3D brain model and 3D electrical field model. As shown inFIG. 71, user interface1162displays 3D brain model1168via 3D environment1164. 3D environment1164is provided to a user through an embodiment of programmer19. Once the user, or clinician, defines the stimulation field, the appropriate stimulation parameters are generated for therapy. Electrical field model1172is generated by a processor, such as processor80, and is displayed within 3D brain model1168. Electrical field model1172may be the 3D approximation of electrical fields described inFIGS. 53-57. Lead icon1170represents the location of lead14in brain18and is shown within electrical field model1172. The clinician may user hand1166to rotate, zoom in, and zoom out of 3D brain model1168to review the proposed stimulation therapy. In some embodiments, the clinician may use hand1166to modify electrical field model1172size, shape, or location. In this manner, the corresponding stimulation parameters will change accordingly.

FIG. 72is a conceptual diagram illustrating a three-dimensional (3D) visualization environment including a 3D brain model and enlarged 3D electrical field model as defined by the user.FIG. 72is similar toFIG. 71. User interface1162displays 3D brain model1178and lead icon1180via 3D environment1164. Electrical field model1182has been increased in size over electrical field model1172ofFIG. 71. The clinician has used hand1174to pull electrical field model1182in the direction of arrow1176to cause this increase in the electrical field model size. Additionally, hand1174may cause electrical stimulation field1182to change location or alter its shape as directed by the clinician.

Changes to electrical field model1182are essentially caused by hand1174forcing changes to the stimulation parameters that define the electrical field model. As electrical field model1182increases in size, the shape of the electrical field model changes to reflect the electrical current propagation within the tissue of brain18(represented by 3D brain model1178). Electrical stimulation field1182may have limits to the size or location of the field based upon the limitations of system10.

FIG. 73is a flow diagram illustrating an example technique for calculating an electrical field model and displaying the field model to the user. The technique is described with reference to programmer19, which may provide any of the user interfaces described above with reference toFIGS. 71 and 72. As shown inFIG. 73, programmer19receives patient anatomy data via user interface1162necessary for creating an electrical field (1184). Programmer19enters the patient anatomy data in stored electrical field model equations or equation sets to satisfy anatomical variable (1186). Programmer19next calculates the electrical field model from the data and equations (1188). Once programmer19receives stimulation input from the clinician via user interface1162defining the stimulation field (1190), the programmer generates the 3D electrical field model according to the stimulation parameters (1192). The 3D electrical field model may be displayed to the clinician via user interface1162(1194). If the clinician desires to change the stimulation input (1196), programmer19receives a change in the stimulation input via user interface1162(1190). If the clinician does not request a stimulation input change (1196), programmer19continues to display the 3D electrical field model to the clinician via user interface1162(1194). Programmer19may also provide a mechanism to exit the viewing of 3D environment1164.

FIGS. 74-76illustrate example three-dimensional (3D) activation field models that show a user which neurons of brain18tissue will be activated by the produced electrical field during therapy.FIG. 74is a conceptual diagram illustrating a 3D environment including a 3D brain model and 3D activation field model. As shown inFIG. 74, user interface1198displays 3D brain model1204via 3D environment1200. 3D environment1200is provided to a user through an embodiment of programmer19or other computing device. Once the user, or clinician, defines the stimulation field, the appropriate stimulation parameters are generated for therapy. An electrical field model, such as described inFIGS. 71-73, is applied to a neuron model of brain tissue to generate activation fields1208,1210and1212(collectively the activation field model) displayed within 3D brain model1204. Activation fields1208,1210and1212are 3D versions of the activation fields described inFIGS. 58-62. Lead icon1206represents the location of lead14in brain18and is shown within activation fields1208,1210and1212. The clinician may use hand1202to rotate, zoom in, and zoom out of 3D brain model1204to review the proposed stimulation therapy. In some embodiments, the clinician may use hand1202to modify the activation field model size, shape, or location. In this manner, activation fields1208,1210and1212may will change accordingly. While the activation field model is separated into three separate activation fields1208,1210and1212, the activation field may include one continuous activation field around lead icon1206or many smaller separated activation fields caused by pockets of neurons in brain18that are not activated by the generated electrical field of the stimulation therapy.

FIG. 75is a conceptual diagram illustrating a three-dimensional (3D) visualization environment including a 3D brain model and enlarged 3D activation field model as defined by the user.FIG. 75is similar toFIG. 74. User interface1198displays 3D brain model1218and lead icon1220via 3D environment1200. Activation fields1222,1224and1226have been increased in size over activation fields1208,1210and1212ofFIG. 74. The clinician has used hand1214to pull the activation fields1222,1224and1226in the direction of arrow1216to cause this increase in the number of activated neurons. Additionally, hand1214may be used to move activation fields1222,1224and1226or alter their shape as directed by the clinician.

Changes to activation fields1222,1224and1226are essentially caused by hand1214forcing changes to the stimulation parameters that define the electrical field model, and thus the activation field model. As the activation field model increases in size, the shape of activation fields1222,1224and1226change to reflect the actual neurons of brain18that would be activated by the electrical field produced by lead14(represented by 3D brain model1220). The activation field model may have limits to the size or location of the field based upon the limitations of system10.

FIG. 76is a flow diagram illustrating an example technique for calculating an activation field model and displaying the field model to the user. The technique is described with reference to programmer19, which may provide any of the user interfaces described above with reference toFIGS. 74 and 75. As shown inFIG. 76, programmer19receives patient anatomy data indicative of the anatomy of patient12via user interface1198(1228) and the programmer calculates the electrical field model from the patient anatomy data (1230). Programmer19then retrieves the neuron model and fits the neuron model to the electrical field (1232). Programmer19next calculates the activation field model based upon the electrical field model and neuron model (1234). Programmer then is able to receive stimulation input from the clinician via user interface1198defining what structures of the anatomical region should be stimulated (1236). Programmer19subsequently generates the 3D activation field model (1238) and user interface1198displays the activation field model to the clinician (1240). If the clinician desires to change the stimulation input (1242), user interface1198receives stimulation input from the clinician modifying the previous stimulation input (1236). If the stimulation input does not need to be changed (1242), the activation field model continues to be displayed by user interface1198(1240). The clinician may also be able to leave viewing the activation field model to deliver the stimulation therapy or change aspects of the stimulation parameters.

Although the disclosure may be especially applicable to the simulation of the deep brain, the invention alternatively may be applied more generally to any type of stimulation wherein the parameters of stimulation programs may be automatically generated based upon a defined stimulation field. As examples, cortical brain stimulation, spinal cord stimulation, sacral or pudendal nerve stimulation, or dorsal root stimulation may benefit from the user interface described herein.

Although this disclosure has referred to neurostimulation applications generally, and DBS and SCS applications more particularly, such applications have been described for purposes of illustration and should not be considered limiting of the invention as broadly embodied and described herein. The invention may be more generally applicable to electrical stimulation of tissue, such as nerve tissue or muscle tissue, and may be applicable to a variety of therapy applications including spinal cord stimulation, pelvic floor stimulation, deep brain stimulation, cortical surface stimulation, neuronal ganglion stimulation, gastric stimulation, peripheral nerve stimulation, or subcutaneous stimulation. Such therapy applications may be targeted to a variety of disorders such as chronic pain, peripheral vascular disease, angina, headache, tremor, Parkinson's disease, epilepsy, urinary or fecal incontinence, sexual dysfunction, obesity, or gastroparesis. Also, the invention is not necessarily limited to use with completely implanted neurostimulators, and may also be applicable to external stimulators coupled to implanted leads via a percutaneous port.

In addition, although electrode array geometries having four or eight axial electrode levels and four angular electrode positions have been described, the disclosure may be applicable to a wide variety of electrode array geometries including virtually any number of axial and angular electrode positions. Again, a complex electrode array geometry generally refers to an arrangement of stimulation electrodes at multiple non-planar or non-coaxial positions, in contrast to simple electrode array geometries in which the electrodes share a common plane or a common axis. An example of a simple electrode array geometry is an array of ring electrodes distributed at different axial positions along the length of a lead. Another example of a simple electrode array geometry is a planar array of electrodes on a paddle lead.

An example of a complex electrode array geometry, in accordance with this disclosure, is an array of electrodes positioned at different axial positions along the length of a lead, as well as at different angular positions about the circumference of the lead. In some embodiments, the electrodes in the complex array geometry may appear similar to non-contiguous, arc-like segments of a conventional ring electrode. A lead with a complex electrode array geometry may include multiple rings of electrode segments. Each axially positioned ring is disposed at a different axial position. Each electrode segment within a given ring is disposed at a different angular position. The lead may be cylindrical or have a circular cross-section of varying diameter. Another example of a complex electrode array geometry is an array of electrodes positioned on multiple planes or faces of a lead. As an illustration, arrays of electrodes may be positioned on opposite planes of a paddle lead or multiple faces of a lead having a polygonal cross-section. Also, electrodes positioned at particular axial or angular positions need not be aligned with other electrodes. Rather, in some embodiments, electrodes may be arranged in a staggered or checkerboard-like pattern.

Further, although a single lead may be useful in various stimulation applications, multiple leads may be useful in other applications such as bi-lateral DBS, SCS, or multi-site stimulation for gastric, pelvic or peripheral nerve stimulation. Accordingly, electrode combinations may be formed between electrodes carried by a single lead, electrode combinations formed between electrodes carried by one lead of a pair of leads, or electrode combinations formed between electrodes on different leads, as well as electrodes carried by a stimulator housing, e.g., in a so-called active can configuration.

The techniques described herein may be techniques may be applied to a programming interface or control interface associated with a clinician programmer, a patient programmer, or both. Hence, a clinician may use a clinician programmer in clinic to program and evaluate different electrode combinations and stimulation parameter values. A patient may use a patient programmer during daily use to adjust parameter values, select different electrode combinations, subject to keepout zones and ranges specified by the clinicians. The clinician programmer or patient programmer may be a small, portable, handheld device, similar to a personal digital assistant (PDA). Alternatively, in the case of a clinician programmer, the programmer may be implemented in a general purpose desktop or laptop computer, computer workstation, or dedicated desktop programming unit.

In addition, the programming functionality described in this disclosure may be used to program an implantable stimulator coupled to one or more implantable leads or an external stimulator coupled to one more percutaneous leads. For example, the invention may be used for trial stimulation or chronic stimulation.

The disclosure also contemplates computer-readable media comprising instructions to cause a processor to perform any of the functions described herein. The computer-readable media may take the form of any volatile, non-volatile, magnetic, optical, or electrical media, such as a random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically-erasable programmable ROM (EEPROM), flash memory, or any other digital media. Programmer19also may contain a more portable removable memory type to enable easy data transfer or offline data analysis.

Various embodiments of the described invention may be implemented using one or more processors that are realized by one or more microprocessors, Application-Specific Integrated Circuits (ASIC), Field-Programmable Gate Arrays (FPGA), or other equivalent integrated or discrete logic circuitry, alone or in any combination.

Many embodiments of the disclosure have been described. Various modifications may be made without departing from the scope of the claims. These and other embodiments are within the scope of the following claims.