Interactive medical visualization system and method for visualizing stimulation lead placement

Abstract

Embodiments herein relate to interactive medical visualization systems and related methods for visualizing the placement of stimulation leads. In one embodiment, a medical visualization system may be included having a video processing circuit, a central processing circuit in communication with the video processing circuit, and a user interface. The user interface may be generated by the video processing circuit and may include a three-dimensional model. The three-dimensional model may include at least a portion of the anatomical structure of the subject and a graphical representation, the graphical representation including at least one cancer treatment stimulation lead and a visible thermal heating zone associated with the graphical representation of the at least one cancer treatment stimulation lead and / or a visible electric field strength zone associated with the graphical representation of the at least one cancer treatment stimulation lead. Other embodiments are also included herein.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application was filed as a PCT International Patent Application on June 26, 2023 in the name of Cardiac Pacemakers, Inc. (a U.S. national corporation, designated as applicant for all countries) and Devon N. Arnholt, a U.S. citizen, Michael J. Kane, a U.S. citizen, and Brian L. Schmidt, a U.S. citizen (designated as inventors for all countries). This application claims priority to U.S. Provisional Application No. 63 / 355,728, filed on June 27, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0003] Embodiments herein relate to interactive medical visualization systems and related methods for visualizing placement of stimulation leads. Background Art

[0004] Various forms of brain cancer, such as glioblastoma, meningioma, etc. can be treated using electrical stimulation. However, in order to be able to effectively treat these diseases and prevent damage to non-target brain tissue, blood vessels and nerves of the subject, it is important to place the electrodes correctly.

[0005] Many instruments with optical devices or electronic imaging cameras allow visual observation of the internal organs of a subject that are otherwise difficult to see. For example, bronchoscopes, endoscopes, etc. allow the clinician to visually observe portions of the subject's anatomy that are otherwise hidden.

[0006] Similarly, many of the technologies used in medical imaging also allow clinicians to visually observe portions of a subject's anatomy. These technologies may include radiography, fluoroscopy, computerized axial tomography (CAT), and magnetic resonance imaging (MRI). However, many of these technologies are two-dimensional or present a two-dimensional display, which may make the results difficult to interpret or present challenges for applying the results in subsequent procedures. Summary of the invention

[0007] Embodiments herein relate to interactive medical visualization systems and related methods for visualizing the placement of stimulation leads. In a first aspect, a medical visualization system may be included having a video processing circuit, a central processing circuit in communication with the video processing circuit, and a user interface. The user interface may be generated by the video processing circuit and may include a three-dimensional model. The three-dimensional model may include at least a portion of an anatomical structure of a subject and a graphical representation, the graphical representation including at least one cancer treatment stimulation lead and a visible thermal heating zone associated with the graphical representation of the at least one cancer treatment stimulation lead.

[0008] In a second aspect, in addition to or in the alternative of one or more of the preceding or following aspects, a visual thermal heating zone provides a graphical representation of temperature surrounding at least one cancer therapy stimulation lead.

[0009] In a third aspect, in addition to or in the alternative of one or more of the preceding or following aspects, a visual thermal heating zone provides a graphical representation of the temperature of tissue surrounding at least one cancer treatment stimulation lead.

[0010] In a fourth aspect, in addition to one or more of the previous or following aspects, or in an alternative to some aspects, the three-dimensional model may also include at least one selected from the group consisting of patient data collected in real time, previously stored patient data, and idealized model data.

[0011] In a fifth aspect, in addition to or in the alternative of one or more of the previous or following aspects, the video processing circuitry may be located remotely from the machine that displays the user interface.

[0012] In a sixth aspect, in addition to or in the alternative to one or more of the previous or following aspects, the video processing circuitry may be co-located with a machine that displays a user interface.

[0013] In a seventh aspect, in addition to or in the alternative of one or more of the previous or following aspects, the three-dimensional model may further include a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0014] In an eighth aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, a graphical representation of at least one cancer therapy stimulation lead may be displayed as being positioned at or near the site of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0015] In a ninth aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, the graphical representation of at least one cancer therapy stimulation lead can be displayed as positioned within a cancerous tumor, a resection cavity, and / or a contrast enhancement region.

[0016] In a tenth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the graphical representation may also include three cancer therapy stimulation leads, wherein the three cancer therapy stimulation leads may be shown as positioned around a center point of a cancerous tumor, a resection cavity, and / or a contrast enhanced region.

[0017] In an eleventh aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, three cancer therapy stimulation leads may be shown positioned approximately 120 degrees around a center point of a cancerous tumor, resection cavity, and / or contrast enhancement region.

[0018] In a twelfth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the graphical representation may further include four cancer therapy stimulation leads, wherein the four cancer therapy stimulation leads may be displayed as being positioned around a center point of the cancerous tumor, resection cavity, and / or contrast enhancement area.

[0019] In a thirteenth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, a graphical representation of four cancer therapy stimulation leads may be displayed positioned at approximately 90 degrees around a center point of a cancerous tumor, resection cavity, and / or contrast enhancement region.

[0020] In a fourteenth aspect, additionally or in the alternative of some aspects, a user interface displays electrode locations to provide therapy based on the location of the cancerous tumor, resection cavity, and / or contrast-enhanced region.

[0021] In a fifteenth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, a user interface displays placement of one or more cancer therapy stimulation leads based on the location of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0022] In a sixteenth aspect, additionally or in the alternative of some aspects, a user interface displays placement of one or more electrodes based on a location of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0023] In a seventeenth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the predetermined treatment parameters displayed by the user interface may include a duty cycle based on the location of the cancerous tumor, the resection cavity and / or the contrast enhancement area.

[0024] In an eighteenth aspect, in addition to or in the alternative of one or more of the preceding or following aspects, at least one cancer therapy stimulation lead may include at least one electrode.

[0025] In a nineteenth aspect, in addition to or in the alternative of one or more of the previous or following aspects, at least one electrode may be insulated to induce directionality in field strength.

[0026] In a twentieth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, at least one electrode may include a heat shield, wherein the heat shield may be configured to shape the electrode of the at least one electrode.

[0027] In a twenty-first aspect, in addition to or in the alternative of one or more of the preceding or following aspects, at least one cancer therapy stimulation lead may include two electrodes.

[0028] In a twenty-second aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, at least a portion of the subject's anatomical structure may include at least one selected from the group consisting of brain, heart, pancreas, lung, liver, uterus, ovary, stomach, prostate, kidney, thyroid, bladder, and intestine.

[0029] In a twenty-third aspect, in addition to one or more of the previous or following aspects, or in an alternative to some aspects, the three-dimensional model can be configured to present the placement of at least one cancer therapy stimulation lead, and wherein the at least one cancer therapy stimulation lead can be placed to avoid one or more critical structures.

[0030] In a twenty-fourth aspect, in addition to or in the alternative of one or more of the previous or following aspects, a user interface informs a user of the field strength.

[0031] In a twenty-fifth aspect, additionally or in the alternative of some aspects, the user interface notifies the user to place one or more additional cancer therapy stimulation leads to increase field strength.

[0032] In a twenty-sixth aspect, additionally or in the alternative of some aspects, the user interface notifies a user when at least one cancer therapy stimulation lead is accessible to a critical structure.

[0033] In a twenty-seventh aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the critical structure may include at least one selected from the group consisting of bones, pituitary gland, blood vessels, hypothalamus, ventricles, brain stem, amygdala, thalamus, cerebellum, and corpus callosum.

[0034] In a twenty-eighth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, a user interface notifies a user when a calculated temperature of a critical structure or other designated area exceeds a programmable maximum temperature value.

[0035] In a twenty-ninth aspect, in addition to one or more of the previous or following aspects, or in an alternative to some aspects, the user interface may include at least one visual burr hole representation, wherein the at least one visual burr hole representation provides a graphical representation of optimal burr hole placement.

[0036] In a thirtieth aspect, additionally or in the alternative of some aspects, at least one visual burr hole representation may be displayed as having a diameter of at least 1 / 4 inch.

[0037] In a thirty-first aspect, in addition to or in the alternative of one or more of the preceding or following aspects, at least one visual burr hole representation may be displayed as having a diameter of approximately 5 / 8 inch.

[0038] In a thirty-second aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the user interface may further include a visual lead trajectory, wherein the visual lead trajectory provides a graphical representation of an optimal trajectory of at least one cancer therapy stimulation lead.

[0039] In a thirty-third aspect, in addition to one or more of the previous or following aspects, or in an alternative to some aspects, the user interface may also include a visual thermal representation of at least a portion of the subject's anatomical structure, wherein the visual thermal representation of at least a portion of the subject's anatomical structure may be associated with the three-dimensional model.

[0040] In a thirty-fourth aspect, additionally or in the alternative of some aspects, a visual thermal representation of at least a portion of the anatomy of the subject estimates a temperature distributed within the three-dimensional model.

[0041] In a thirty-fifth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, aspects of the visible thermal heating zone are calculated based on power and duty cycle settings of electrodes disposed on at least one cancer therapy stimulation lead.

[0042] In a thirty-sixth aspect, in addition to or in the alternative of one or more of the previous or following aspects, a user interface may be configured to display one or more therapy vector patterns between electrodes.

[0043] In a thirty-seventh aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, aspects of the visible thermal heating zone can be calculated based on a treatment vector pattern between electrodes, power of the electrodes, and a duty cycle of the electrodes.

[0044] In a thirty-eighth aspect, a medical visualization system may be included, having a video processing circuit, a central processing circuit in communication with the video processing circuit, and a user interface, wherein the user interface may be generated by the video processing circuit. The user interface may include a three-dimensional model, the three-dimensional model may include at least a portion of the subject's anatomy, and a graphical representation including at least one cancer therapy stimulation lead and a visible thermal heating zone. The visible thermal heating zone may be associated with the graphical representation of the at least one cancer therapy stimulation lead. The system may also include a notification system, wherein the notification system may be configured to provide one or more notifications to a user.

[0045] In a thirty-ninth aspect, additionally or in the alternative of some aspects, a notification system notifies a user when at least one cancer therapy stimulation lead is accessible to one or more critical structures.

[0046] In a fortieth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the critical structure may include at least one selected from the group consisting of bones, pituitary gland, blood vessels, hypothalamus, ventricles, brain stem, amygdala, thalamus, cerebellum and corpus callosum.

[0047] In a forty-first aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the medical visualization system notifies a user when a calculated temperature of a critical structure or other designated area exceeds a programmable maximum temperature value.

[0048] In a forty-second aspect, additionally or in the alternative of some aspects, the notification system notifies the user to place one or more additional cancer therapy stimulation leads to increase field strength.

[0049] In a forty-third aspect, in addition to or in the alternative of one or more of the previous or following aspects, the notification system notifies the user to place one or more additional electrodes to increase field strength.

[0050] In a forty-fourth aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, the one or more additional electrodes may include at least one from the group consisting of a subcutaneous electrode, a subcranial electrode, and an external electrode.

[0051] In a forty-fifth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the notification system notifies the user of the field strength.

[0052] In aspect 46, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the notification system may include at least one selected from the group consisting of a pop-up alert, a sound alert, a texture change in the graphical representation, and a color change in the graphical representation.

[0053] In a forty-seventh aspect, a method for visualizing placement of a cancer therapy lead may be included, the method comprising acquiring three-dimensional imaging data of a region of tissue at or near a cancerous tumor, a resection cavity, and / or a contrast enhancing region; generating a predetermined model using the three-dimensional imaging data, wherein the predetermined model may be configured to assign one or more electrical properties to the region of tissue; positioning one or more cancer therapy stimulation leads to the region of tissue within the predetermined model at or near the cancerous tumor, the resection cavity, and / or the contrast enhancing region; and calculating one or more electric fields to the region of tissue at or near the cancerous tumor, the resection cavity, and / or the contrast enhancing region, and superimposing one or more electric field lines on the predetermined model.

[0054] In a 48th aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the method may further include calculating one or more temperatures of a region of tissue at or near a cancerous tumor, a resection cavity, and / or a contrast-enhanced region, and superimposing one or more temperature contours onto a predetermined model.

[0055] In a forty-ninth aspect, in addition to or in the alternative of one or more of the previous or following aspects, wherein the predetermined model can be configured to predict changes in a region of tissue over a period of time.

[0056] In a fiftieth aspect, in addition to or in the alternative of one or more of the preceding or following aspects, the change is caused by a void or tissue swelling left after resection of a cancerous tumor, resection cavity, and / or contrast enhanced area.

[0057] In a fifty-first aspect, in addition to or in the alternative of one or more of the previous or following aspects, one or more electrical properties may be assigned based on a type of tissue.

[0058] In a fifty-second aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the type of tissue may include at least one selected from the group consisting of cancerous tissue, muscle, bone, and healthy tissue.

[0059] In a fifty-third aspect, in addition to or in the alternative of one or more of the previous or following aspects, the method may further include setting a maximum temperature limit for healthy tissue.

[0060] In a fifty-fourth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the method may also include notifying a system user when the calculated temperature of the critical structure or other designated area exceeds the maximum temperature limit.

[0061] In a fifty-fifth aspect, in addition to or in the alternative of one or more of the previous or following aspects, the method may further comprise setting a maximum temperature limit for the cancerous tissue.

[0062] In a fifty-sixth aspect, in addition to or in the alternative of one or more of the previous or following aspects, the method may further include notifying a system user when the calculated temperature of the cancerous tissue exceeds a maximum temperature limit.

[0063] In a fifty-seventh aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the method may further include setting a minimum electric field strength.

[0064] In a fifty-eighth aspect, in addition to or in the alternative of one or more of the preceding or following aspects, one or more cancer therapy stimulation leads are independently controllable.

[0065] In a fifty-ninth aspect, in addition to or in the alternative of one or more of the preceding or following aspects, one or more cancer therapy stimulation leads comprise one or more electrodes.

[0066] In a sixtieth aspect, in addition to or in the alternative of one or more of the previous or following aspects, wherein one or more cancer therapy stimulation leads include a temperature measurement component.

[0067] In a sixty-first aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, one or more cancer therapy stimulation leads include a thermal gradient and a therapy gradient extending outwardly from the one or more cancer therapy stimulation leads.

[0068] In a sixty-second aspect, in addition to or in the alternative of one or more of the preceding or following aspects, the three-dimensional imaging data may be obtained using magnetic resonance imaging data or computed tomography data.

[0069] In a sixty-third aspect, a medical visualization system may be included having a video processing circuit, a central processing circuit in communication with the video processing circuit, and a user interface, wherein the user interface may be generated by the video processing circuit. The user interface may include a three-dimensional model including at least a portion of an anatomical structure of a subject and a graphical representation including at least one cancer therapy stimulation lead and a visible electric field intensity region. The visible electric field intensity region may be associated with the graphical representation of the at least one cancer therapy stimulation lead.

[0070] In a sixty-fourth aspect, additionally or in the alternative of some aspects, the visible electric field strength region comprises a graphical representation of electric field strength surrounding at least one cancer therapy stimulation lead.

[0071] In aspect sixty-fifth, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the three-dimensional model may also include at least one selected from the group consisting of patient data collected in real time, previously stored patient data, and idealized model data.

[0072] In a sixty-sixth aspect, in addition to or in the alternative of one or more of the preceding or following aspects, the three-dimensional model may further include a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0073] In a sixty-seventh aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, a graphical representation of at least one cancer therapy stimulation lead may be displayed as being positioned at or near the site of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0074] In a sixty-eighth aspect, additionally or in the alternative of some aspects, a graphical representation of at least one cancer therapy stimulation lead may be displayed as positioned within a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0075] In a sixty-ninth aspect, in addition to or in the alternative of one or more of the previous or following aspects, a user interface displays electrode locations to provide treatment based on the location of the cancerous tumor, resection cavity, and / or contrast-enhanced region.

[0076] In a seventieth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, a user interface displays placement of one or more cancer therapy stimulation leads based on the location of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0077] In a seventy-first aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, a user interface displays placement of one or more electrodes based on the location of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0078] In a seventy-second aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, the predetermined treatment parameters displayed by the user interface may include a duty cycle based on the location of the cancerous tumor, the resection cavity, and / or the contrast-enhanced region.

[0079] In a seventy-third aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, at least a portion of the subject's anatomy may include at least one selected from the group consisting of a brain, a heart, a pancreas, a lung, a liver, a uterus, an ovary, a stomach, a prostate, a kidney, a thyroid gland, a bladder, and an intestine.

[0080] In a seventy-fourth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, wherein the three-dimensional model can be configured to present the placement of at least one cancer therapy stimulation lead, and wherein the at least one cancer therapy stimulation lead can be positioned to avoid one or more critical structures.

[0081] In a seventy-fifth aspect, in addition to or in the alternative of one or more of the previous or following aspects, a user interface informs a user of field strength.

[0082] In a seventy-sixth aspect, additionally or in the alternative of some aspects, the user interface notifies the user to place one or more additional cancer therapy stimulation leads to increase field strength.

[0083] In a seventy-seventh aspect, additionally or in the alternative of some aspects, a user interface notifies a user when at least one cancer therapy stimulation lead is accessible to a critical structure.

[0084] In aspect seventy-eight, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, the critical structure may include at least one selected from the group consisting of bone, pituitary gland, blood vessel, hypothalamus, ventricle, brain stem, amygdala, thalamus, cerebellum and corpus callosum.

[0085] In a seventy-ninth aspect, in addition to one or more of the preceding or following aspects, or in an alternative to some aspects, the user interface may include at least one visual burr hole representation, wherein the at least one visual burr hole representation provides a graphical representation of optimal burr hole placement.

[0086] In an eightieth aspect, in addition to or in the alternative of one or more of the previous or following aspects, the user interface may further include a visual lead trajectory, wherein the visual lead trajectory provides a graphical representation of an optimal trajectory of at least one cancer therapy stimulation lead.

[0087] In an eighty-first aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the user interface may also include a visual thermal representation of at least a portion of the subject's anatomy, wherein the visual thermal representation may be associated with the three-dimensional model.

[0088] In an eighty-second aspect, additionally or in the alternative of some aspects, one or more of the preceding or following aspects, the visual thermal representation comprises an estimate of the temperature throughout the three-dimensional model.

[0089] In an eighty-third aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, a user interface notifies a user when an estimated temperature of a critical structure or other designated area exceeds a programmable maximum temperature value.

[0090] In an eighty-fourth aspect, in addition to or in the alternative of one or more of the preceding or following aspects, a user interface may be configured to display one or more therapy vector patterns between electrodes.

[0091] In an eighty-fifth aspect, a medical visualization system may be included, comprising: a video processing circuit; a central processing circuit, wherein the central processing circuit can communicate with the video processing circuit; and a user interface, wherein the user interface can be generated by the video processing circuit, the user interface can include a three-dimensional model, the three-dimensional model can include at least a portion of the subject's anatomy; a graphical representation, the graphical representation can include at least one cancer therapy stimulation lead; a visible thermal heating zone, wherein the visible thermal heating zone can be associated with the graphical representation of at least one cancer therapy stimulation lead; and a visible electric field strength zone, wherein the visible electric field strength zone can be associated with the graphical representation of at least one cancer therapy stimulation lead.

[0092] In an eighty-sixth aspect, additionally or in the alternative of some aspects, the visual thermal heating zone comprises a graphical representation of temperature surrounding at least one cancer therapy stimulation lead.

[0093] In an eighty-seventh aspect, additionally or in the alternative of some aspects, the visible thermal heating zone comprises a graphical representation of the temperature surrounding tissue adjacent to at least one cancer therapy stimulation lead.

[0094] In an 88th aspect, additionally or in the alternative of some aspects, the visible electric field strength region comprises a graphical representation of the electric field strength surrounding at least one cancer therapy stimulation lead.

[0095] In an eighty-ninth aspect, additionally or in the alternative of some aspects, the visible electric field strength region comprises a graphical representation of electric field strength surrounding tissue adjacent to at least one cancer therapy stimulation lead.

[0096] In a ninetieth aspect, in addition to or in the alternative of one or more of the preceding or following aspects, wherein one of the visible thermal heating zone and the visible electric field strength zone is superimposed on the other.

[0097] In aspect ninety-one, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the three-dimensional model may also include at least one selected from the group consisting of patient data collected in real time, previously stored patient data, and idealized model data.

[0098] In a ninety-second aspect, in addition to or in the alternative of one or more of the preceding or following aspects, the three-dimensional model may further include a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0099] In a ninety-third aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, the graphical representation of at least one cancer therapy stimulation lead may be displayed as being positioned at or near the site of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0100] In a ninety-fourth aspect, additionally or in the alternative of some aspects, the graphical representation of at least one cancer therapy stimulation lead may be displayed as positioned within a cancerous tumor, a resection cavity, and / or a contrast enhancement region.

[0101] In a ninety-fifth aspect, additionally or in the alternative of some aspects, a user interface displays electrode locations to provide therapy based on the location of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0102] In a ninety-sixth aspect, in addition to or in the alternative of one or more of the preceding or following aspects, a user interface displays placement of one or more cancer therapy stimulation leads based on the location of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0103] In a ninety-seventh aspect, in addition to or in the alternative of one or more of the preceding or following aspects, a user interface displays placement of one or more electrodes based on the location of a cancerous tumor, a resection cavity, and / or a contrast-enhanced region.

[0104] In a ninety-eighth aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, the predetermined treatment parameters displayed by the user interface may include a duty cycle based on the location of the cancerous tumor, the resection cavity, and / or the contrast enhancement area.

[0105] In a ninety-ninth aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, at least a portion of the subject's anatomical structure may include at least one selected from the group consisting of brain, heart, pancreas, lung, liver, uterus, ovary, stomach, prostate, kidney, thyroid, bladder, and intestine.

[0106] In a hundredth aspect, in addition to one or more of the previous or following aspects, or in an alternative to some aspects, wherein the three-dimensional model can be configured to present the placement of at least one cancer therapy stimulation lead, and wherein the at least one cancer therapy stimulation lead can be positioned to avoid one or more critical structures.

[0107] In a one hundred and first aspect, in addition to or in the alternative of one or more of the previous or following aspects, a user interface informs a user of field strength.

[0108] In a one hundred second aspect, additionally or in the alternative of some aspects, a user interface notifies a user to place one or more additional cancer therapy stimulation leads to increase field strength.

[0109] In a one hundred third aspect, additionally or in the alternative of some aspects, a user interface notifies a user when at least one cancer therapy stimulation lead is accessible to a critical structure.

[0110] In aspect one hundred and fourth, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, the critical structure may include at least one selected from the group consisting of bone, pituitary gland, blood vessel, hypothalamus, ventricle, brain stem, amygdala, thalamus, cerebellum, and corpus callosum.

[0111] In aspect one hundred and five, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the user interface may include at least one visual burr hole representation, wherein the at least one visual burr hole representation provides a graphical representation of optimal burr hole placement.

[0112] In a one hundred sixth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, the user interface may further include a visual lead trajectory, wherein the visual lead trajectory provides a graphical representation of an optimal trajectory of at least one cancer therapy stimulation lead.

[0113] In aspect one hundred and seventh, in addition to one or more of the previous or following aspects, or in an alternative to some aspects, the user interface may also include a visual thermal representation of at least a portion of the subject's anatomical structure, wherein the visual thermal representation of at least a portion of the subject's anatomical structure may be associated with the three-dimensional model.

[0114] In a one hundred and eighth aspect, additionally or in the alternative of some aspects, a visual thermal representation of at least a portion of the anatomy of the subject estimates a temperature of the entire three-dimensional model.

[0115] In a one hundred and ninth aspect, in addition to one or more of the previous or following aspects, or in the alternative of some aspects, aspects of the visual thermal representation of at least a portion of the subject's anatomy are calculated based on power and duty cycle settings of electrodes disposed on at least one cancer therapy stimulation lead.

[0116] In a one hundred and tenth aspect, in addition to one or more of the preceding or following aspects, or in the alternative of some aspects, various aspects of a visual thermal representation of at least a portion of the subject's anatomy may be calculated based on a treatment vector pattern between electrodes, power of the electrodes, and a duty cycle of the electrodes.

[0117] In a one hundred eleventh aspect, in addition to or in the alternative of one or more of the preceding or following aspects, a user interface can be configured to display one or more therapy vector patterns between electrodes.

[0118] The present disclosure is an overview of some of the teachings of the present application and is not intended to be an exclusive or exhaustive treatment of the subject matter. Further details can be found in the specific embodiments and the appended claims. Other aspects will be apparent to those skilled in the art upon reading and understanding the following detailed description and viewing the accompanying drawings which form a part thereof, each of which should not be construed as having a limiting meaning. The scope of this article is defined by the appended claims and their legal equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0119] Aspects of the present invention may be more fully understood in conjunction with the following drawings, in which:

[0120] Figure 1is a schematic diagram of a medical visualization system according to various embodiments herein.

[0121] Figure 2 is a schematic diagram of a user interface showing electric field strength regions according to various embodiments herein.

[0122] Figure 3 is a schematic diagram of a user interface illustrating a thermal heating zone according to various embodiments herein.

[0123] Figure 4 is a schematic diagram of a user interface illustrating placement of various cancer treatment stimulation leads according to various embodiments herein.

[0124] Figure 5 is a schematic diagram of a user interface illustrating placement of various cancer treatment stimulation leads according to various embodiments herein.

[0125] Figure 6 is a schematic diagram of a user interface showing multiple views of placement of cancer therapy stimulation leads according to various embodiments herein.

[0126] Figure 7 is a top view of a graphical representation of the placement of various cancer treatment stimulation leads in the area of ​​a cancerous tumor in accordance with various embodiments herein.

[0127] Figure 8 is a top view of a graphical representation of the placement of four cancer therapy stimulation leads in the area of ​​a cancerous tumor in accordance with various embodiments herein.

[0128] Fig. 9 is a top view of a graphical representation of the placement of two cancer therapy stimulation leads in the area of ​​a cancerous tumor in accordance with various embodiments herein.

[0129] Fig.10 is a top view of a graphical representation of placement of a cancer therapy stimulation lead in the area of ​​a cancerous tumor in accordance with various embodiments herein.

[0130] Fig.11 is a top view of a graphical representation of the placement of two cancer therapy stimulation leads in the area of ​​a cancerous tumor in accordance with various embodiments herein.

[0131] Fig.12 is a top view of a graphical representation of the placement of two cancer therapy stimulation leads and subcutaneous electrodes in the area of ​​a cancerous tumor in accordance with various embodiments herein.

[0132] Fig.13 is a schematic diagram of a graphical representation of the placement of various cancer treatment stimulation leads in the region of a cancerous tumor in accordance with various embodiments herein.

[0133] Fig.14 is a schematic diagram of a cancer treatment stimulation lead according to various embodiments herein.

[0134] Fig.15 is a schematic cross-sectional view of a cancer treatment stimulation lead according to various embodiments herein.

[0135] Fig.16 is a diagram of various components of a medical visualization system according to various embodiments herein.

[0136] Fig.17

[0013] Methods for visualizing placement of cancer treatment stimulation leads according to various embodiments herein.

[0137] Fig.18 is a schematic diagram of a user interface showing electric field strength regions according to various embodiments herein.

[0138] Fig.19 is a schematic diagram of a user interface illustrating a thermal heating zone according to various embodiments herein.

[0139] Although the embodiments are susceptible to various modifications and alternative forms, the specific details thereof have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that the scope of the present invention is not limited to the specific embodiments described. On the contrary, it is intended to cover modifications, equivalents and substitutes that fall within the spirit and scope of this article. DETAILED DESCRIPTION

[0140] Many techniques for medical imaging allow clinicians to observe portions of a subject's anatomy and collect data about the anatomy. These techniques may include radiography, fluoroscopy, computerized axial tomography (CAT), ultrasound, and magnetic resonance imaging (MRI). However, many of these techniques present displays that are difficult to interpret or otherwise present challenges for use in subsequent surgery.

[0141] Many invasive surgeries may require the correct placement of medical device equipment, such as electrical stimulation leads. Correct placement of various devices in certain areas of the subject's anatomy is critical to providing targeted therapy. In some scenarios, the correct placement of the device is also critical to minimizing damage to surrounding healthy tissue. For example, when placing an electrical stimulation lead that applies an electric field strength sufficient to provide treatment when treating a tumor resection site, a cavity, or the tumor itself, it is important to minimize damage to surrounding healthy tissue, including blood vessels or nerves. In the context of a tumor resection site or tumor in the head, there is a particular need to minimize damage to healthy tissue.

[0142] Embodiments herein relate to an interactive medical visualization system that uses a three-dimensional model of a subject's anatomy and a virtual stimulation lead to determine placement of an electrical stimulation lead. The medical visualization system may use the three-dimensional model of the subject's anatomy to inform optimized placement of the electrical stimulation lead in the subject's anatomy, and may also provide a user with interactive capabilities to improve the planned placement of the electrical stimulation lead prior to a surgical procedure for actual placement. As discussed herein, visual placement of the electrical stimulation lead may be optimized for treatment of the subject's anatomy and safety of the subject. Additionally, the medical visualization system may be configured to provide a user with interactive capabilities to identify how different possible positions of the virtual stimulation lead may focus treatment on a desired target area while avoiding tissue damage to healthy tissue.

[0143] Reference now Figure 1 , a schematic diagram of a medical visualization system 100 according to various embodiments herein is shown. The medical visualization system 100 may include a user interface 102. The user interface 102 may be generated by a video processing circuit (discussed in detail below) and projected to a video display 104 for the user. The video processing circuit may be local to the user computer 106, or it may be located at a central node or server on or off-site. In various embodiments, the video processing circuit is co-located with the computer that displays the user interface. The medical visualization system 100 may be configured to accept input from the user via various user interface devices, including but not limited to a keyboard 108 and / or a computer mouse 110. It should be understood that various additional user interface devices are contemplated herein, including one or more of a keyboard, a mouse, a joystick, a touchpad, a touch screen, a smart pen, a stylus, voice commands, and the like.

[0144] The user interface 102 of the medical visualization system 100 may include various features presented to the user. The user interface 102 may include a three-dimensional model of at least a portion of the subject's anatomy. In various embodiments, the three-dimensional model may include, for example, Figure 1 1. A representation of a brain 112 is shown. However, the application of the present invention is not limited to the brain, and in some embodiments, the user interface may include a three-dimensional model of one or more tissues, including the heart, pancreas, lungs, liver, uterus, ovaries, stomach, prostate, kidneys, thyroid, bladder, and intestines. Other tissue types may also be presented in the three-dimensional visualization system, including blood vessels, lymphatic vessels, bones, neural tissue, and connective tissue.

[0145] In a given organ or organ structure, tissue substructures and subtypes can be represented. For example, in the brain, gray matter, white matter, ventricles, etc. can be represented. As another example, in the kidney, cortex, medulla, collecting ducts, etc. can be distinguished.

[0146] In various embodiments, user interface 102 may also include and / or be used to construct a model of a contrast enhanced volume / region / area of ​​the subject's anatomy.

[0147] The three-dimensional model may extend in X, Y, and Z dimensions and may be manipulated by the user to change the viewpoint on the user interface 102. The user interface 102 may also include various interactive menu bars, radio buttons, form fields, toggle switches, and the like.

[0148] The medical visualization system 100 may be configured to present a three-dimensional model using medical imaging data obtained from a subject or, for example, based on data from a subject population. It should be understood that a three-dimensional model of an anatomical structure of a subject may be generated using a variety of data sources, including subject data collected in real time, previously stored subject data (such as data stored in a file, folder, and / or database), and idealized model data. Subject data collected in real time may include data, such as medical imaging data, including but not limited to radiographic data, fluoroscopic data, computer axial tomography (CAT) data, magnetic resonance imaging (MRI) data, camera data, and the like. Previously stored subject data may include data, such as medical imaging data, including but not limited to radiographic data, fluoroscopic data, computer axial tomography (CAT) data, magnetic resonance imaging (MRI) data, camera data, and the like.

[0149] In some embodiments, idealized model data can be used to visualize and include anatomical structures, including but not limited to idealized models of major organs (heart, lungs, liver, kidneys, brain, etc.), joints, skeletal structures, muscle tissue, thorax, vascular system, central and peripheral venous systems, cardiopulmonary system, lymphatic system, liver system, kidney system, head and brain, sinuses, etc. and / or medical devices used in medical procedures, including but not limited to implants, heart valves, embolic protection devices, stents, grafts, medical instruments, cardiac rhythm management devices, pacemakers, implantable cardioverter defibrillators, cardiac resynchronization therapy devices, ventricular assist devices, etc. Idealized model data can be stored in a CAD file format, including information about the geometry (wireframe, surface, solid, etc.), or can be stored in other file formats, including similar information about the idealized model. It should be understood that the idealized model data may include data obtained from population-level data of a representative group of age-matched, gender-matched, and size-matched individuals. In some embodiments, the idealized model data can be generated from averaged population-level data.

[0150] The medical visualization system 100 can be configured to use the three-dimensional model and calculate the placement of at least one cancer therapy stimulation lead to be used to treat the medical condition. As part of the calculation, the medical visualization system can assign electrical properties to tissue types of the three-dimensional model. For example, the medical visualization system can assign electrical properties to healthy tissue, cancerous tissue, and various critical structures. As used herein, the term "critical structure" can refer to various tissues, including one or more of bone, nerve, pituitary gland, blood vessel, hypothalamus, ventricle, brainstem, amygdala, thalamus, cerebellum, or corpus callosum. The electrical property values ​​of healthy tissue, cancerous tissue, and critical structures can be referenced using a lookup table of expected scenarios, or can be obtained by performing calculations based on the tissue type identified by the three-dimensional model.

[0151] Using the assignment of corresponding tissue types, the medical visualization system 100 can calculate and identify optimal placement of at least one therapeutic stimulation lead in the anatomy of the subject to treat a medical condition or otherwise provide therapy in the subject. The medical conditions and / or therapies treated can include, but are not limited to, treating a tumor resection site, region, or cavity to prevent cancer recurrence, treating a tumor, cancerous tumor, precancerous lesion, region, or tissue area of ​​concern or risk, or other cancer or related conditions. In addition to cancer, the medical conditions treated herein can include dystonia, epilepsy, cancerous tumors, obsessive compulsive disorder, or Parkinson's disease.

[0152] In various embodiments, the medical visualization system 100 may be configured to calculate placement of at least one cancer therapy stimulation lead by avoiding one or more critical structures present in a three-dimensional model of the subject's anatomy. Critical structures may include any portion of the subject's anatomy that may be damaged or have reduced functionality if disrupted by a foreign object. For example, the medical visualization system may be configured to determine placement of at least one cancer therapy stimulation lead to avoid various critical structures, including bones, nerves, blood vessels, pituitary gland, hypothalamus, ventricles, brainstem, amygdala, thalamus, cerebellum, or corpus callosum. In various embodiments, the medical visualization system may be configured to calculate placement of at least one cancer therapy stimulation lead to treat the subject's condition and avoid one or more critical structures.

[0153] The medical visualization system 100 can be configured to calculate not only the location of at least one cancer therapy stimulation lead, but also the number of cancer therapy stimulation leads required, the number of electrodes required on each cancer therapy stimulation lead, and the pattern and timing of the electrode duty cycle. Exemplary cancer therapy stimulation leads are disclosed in commonly owned U.S. Patent Application No. 63 / 298,528, the contents of which are incorporated herein by reference in their entirety.

[0154] The medical visualization system herein can be configured to construct a model of the electric field strength zones associated with cancer therapy stimulation leads, which can be used to further improve the placement of cancer therapy stimulation leads. In general, the field in a zone or region can be estimated at any point in time based on active electrodes. Now referring to Figure 2 , shows a schematic diagram of a user interface 102 showing a graphical representation of electric field strength regions according to various embodiments herein. The user interface 102 may include a three-dimensional model of at least a portion of an anatomical structure of a subject, such as a brain 112. The three-dimensional model of the anatomical structure of the subject may also include a cancerous tumor 202 ( Figure 2 In various embodiments, the user interface 102 may include a menu bar 200 that includes various interactive menu options such as, but not limited to, File, Edit, User, Command, Effect, Mode, View, Help, etc.

[0155] The user interface 102 may display a graphical representation of at least one cancer treatment stimulation lead positioned at a treatment site within the three-dimensional model of the subject's anatomy. Figure 2 In the illustrated embodiment, two cancer treatment stimulation leads 204 and 206 are present in a target area for treatment, such as opposite sides of a cancerous tumor 202. In various embodiments herein, the area of ​​the cancerous tumor 202 shown may instead represent a tumor resection site or region. Figure 2 Two cancer therapy stimulation leads are shown, but it should be understood that in some embodiments, the user interface 102 can display 1 to 5 cancer therapy stimulation leads. In various embodiments, the user interface 102 can display 1, 2, 3, 4, or 5 cancer therapy stimulation leads. In various embodiments, more than 5 cancer therapy stimulation leads can be used.

[0156] The medical visualization system herein may be configured to provide optimal placement of one or more cancer treatment stimulation leads and may provide a graphical representation of the electric field regions at the lead placement sites superimposed on a three-dimensional model. Figure 2 A graphical representation of an electric field strength region 208 associated with cancer therapy stimulation leads 204 and 206 is included. The graphical representation of the electric field strength region 208 may include one or more electric field strength gradients as represented by electric field strengths 210, 212, 214, 216, 218, and 220 that decrease in strength in a radial direction away from the center of the cancer therapy stimulation lead 204. It should be understood that each cancer therapy stimulation lead in the graphical representation may include an electric field strength gradient. In various embodiments, each cancer therapy stimulation therapy lead may include the same electric field strength gradient. In various other embodiments, each cancer therapy stimulation therapy lead may include a different electric field strength gradient.

[0157] An electric field strength scale 222 including electric field strength values ​​may be included as a legend in the user interface 102 to identify the value of the electric field strength depicted on the display. Figure 2 The electric field strength in FIG. 20 is represented as discrete regions within electric field strength zones 208, but it should be understood that the strength of the electric field strength may decrease in a diffuse gradient (or a continuous gradient) in a radial direction away from the center of the cancer therapy stimulation lead, rather than in discrete circular regions (or in a step gradient). It should also be understood that in some embodiments, there is overlap between electric field strength zones centered on one or more cancer therapy stimulation leads, as will be described below with respect to FIG. Figures 7 to 12 In various embodiments, overlapping electric field strength regions may result in an increase in electric field strength that is greater than non-overlapping electric field strength regions. However, it should be understood that in many cases, the nature of the field increase is not simply a matter of looking at the intersection of the various field gradients. However, embodiments herein may use various techniques as described herein to determine the actual shape of the field enhancement.

[0158] In various embodiments, the electric field strength modeled by the medical visualization system may be calculated using various methods. In some embodiments, the medical visualization system may calculate the local electric field strength at the treatment site as the quotient E=J / σ, where J is the current density of the tissue at the treatment site, and σ is the tissue conductivity. In some embodiments, the medical visualization system may calculate the average electric field strength at the treatment site as the quotient E=I / Aσ, where I is the current of the stimulation lead, A is the active electrode area, and σ is the tissue conductivity. For the area proximal to the stimulation lead, the electric field strength may be approximated as E≈I / A(R2 / R1)σ, where I is the current of the stimulation lead, A is the active electrode area, R2 is the radial distance from the surface of the stimulation lead, R1 is the radius of the stimulation lead, and σ is the tissue conductivity. In some embodiments, in order to make measurements at greater distances (such as more than a few diameters or more than a few centimeters from the stimulation lead), the electric field strength may be calculated using conventional finite element methods (FEM), model-based estimation, and / or lookup tables.

[0159] In various embodiments, the electric field strength modeled by the medical visualization system may include 0 volts / cm (V / cm) to 70 V / cm, or 0 volts / cm (V / cm) to 25 V / cm, or 0 volts / cm (V / cm) to 10 V / cm, or 0 volts / cm (V / cm) to 5 V / cm. In some embodiments, the electric field strength may be greater than or equal to 0 V / cm, 0.01 V / cm, 1 V / cm, 2 V / cm, 3 V / cm, 4 V / cm, 5 V / cm, 7.5 V / cm, 10 V / cm, 15 V / cm, 20 V / cm, 30 V / cm, 40 V / cm, 50 V / cm, 60 V / cm, or 70 V / cm, or an amount within a range between any of the foregoing values.

[0160] The electric field strengths described herein may be modeled at a delivery power of 0.1 Watt (W) to 20 W or more, 0.1 Watt (W) to 15 W, 0.1 Watt (W) to 10 W, 0.1 Watt (W) to 7.5 W, 0.1 Watt (W) to 5 W, 2 Watts (W) to 5 W, etc. In some embodiments, the electric field strengths described herein may be modeled at a delivery power greater than or equal to 0.10 W, 0.35 W, 0.60 W, 0.85 W, 1.10 W, 1.35 W, 1.50 W, 2 W, 2.5 W, 3 W, 3.5 W, 4 W, 5 W, 7.5 W, 10 W, 12.5 W, 15 W, 17.5 W, 20 W, or an amount falling within a range between any of the foregoing values.

[0161] In some embodiments, the system may be configured to accept user input regarding a region of interest around a tumor or surgical tumor resection site. For example, the user input may mark the tumor site or surgical site, such as by directly interacting with the user interface using a touch interface or input device, such as a pen, mouse, or keyboard (or the information may be pre-inserted), and specify a specific distance (such as 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 centimeters or more, or a number falling within a range between any of the foregoing values), and the calculated field strength within that region is then displayed by the medical visualization system. In that manner, the system may specifically highlight information about the field strength in the region of greatest interest to the clinician or other system user. In some embodiments, the system may be configured to display a field strength gradient within the region of interest. In some embodiments, the system may be configured to display an area within the region of interest where the field strength exceeds a threshold value (such as exceeding a minimum threshold value) as set by user input. In some embodiments, the system may be configured so that a user with a therapeutic field strength requirement may select a region of interest (a tumor, a tumor resection boundary region, a specific anatomical structure, a contrast-enhanced region, etc.), and the system may calculate the parameters necessary to provide a region of interest that meets the therapeutic field strength requirement. The region of interest may be designated by accepting user input, such as through a touch screen interface, pointing device, keyboard commands, etc. In some embodiments, using the suggested electrode and / or lead positions, the system may calculate and / or report an estimated power required to achieve a local minimum field or a local average field strength at a given site, region, or area of ​​interest.

[0162] In addition to or in lieu of modeling field strength, the medical visualization system of the present invention may also be configured to model the thermal heating zone associated with the cancer therapy stimulation lead, which may also be used to further improve the placement of the cancer therapy stimulation lead. Figure 3 , shows a schematic diagram of a user interface 102 of an embodiment showing a graphical representation of a thermal heating zone according to various embodiments herein. The user interface 102 may include a three-dimensional model of at least a portion of an anatomical structure of a subject, such as a brain 112. The three-dimensional model of the anatomical structure of the subject may also include a cancerous tumor 202 ( Figure 3 In various embodiments, the user interface 102 may include a menu bar 200 that includes various interactive menu options such as, but not limited to, File, Edit, User, Command, Effect, Mode, View, Help, etc.

[0163] The user interface 102 may display a graphical representation of at least one cancer therapy stimulation lead positioned at a treatment site within the three-dimensional model of the subject's anatomy. Figure 3 In the illustrated embodiment, two cancer treatment stimulation leads 204 and 206 are present on opposite sides of a cancerous tumor 202. Figure 3 Two cancer therapy stimulation leads are shown, but it should be understood that in some embodiments, the user interface 102 can display 1 to 5 cancer therapy stimulation leads. In various embodiments, the user interface 102 can display 1, 2, 3, 4, or 5 cancer therapy stimulation leads. In various embodiments, more than 5 cancer therapy stimulation leads can be used.

[0164] The medical visualization system herein may be configured to provide optimal placement of one or more cancer therapy stimulation leads and may provide a graphical representation of thermal heating zones at the lead placement sites superimposed on a three-dimensional model. Figure 3 A virtual thermal heating zone 300 associated with the cancer therapy stimulation wires 204 and 206 is included. The graphical representation of the thermal heating zone 300 may include one or more thermal heating gradients, including temperatures 310, 312, 314, 316, 318, and 320 whose intensity may decrease in a radial direction away from the center of the cancer therapy stimulation wire 204. It should be understood that each cancer stimulation therapy wire in the graphical representation may include a thermal heating zone gradient. In various embodiments, each cancer therapy stimulation therapy wire may include the same thermal heating zone gradient. In various other embodiments, each cancer therapy stimulation therapy wire may include a different thermal heating zone gradient. In various embodiments, each estimate of the thermal gradient may be configured to include parameter contributions of tissue impedance, treatment duty cycle, electrode thermal diffusion, return electrode, and local thermal impedance, as well as other factors that may include daily or special cause thermal fluctuations.

[0165] A temperature scale 324 may be included as a legend in the user interface 102 to identify the value of the temperature depicted on the display. Figure 3 The temperatures in are represented as discrete areas within the thermal heating zone 300, but it should be understood that the intensity of the temperature will decrease in a diffuse gradient (or continuous gradient) in the radial direction away from the center of the cancer therapy stimulation lead, rather than in different circular areas (or in a step gradient). It should also be understood that in some embodiments, there is overlap between thermal heating zones centered on one or more cancer therapy stimulation leads, as will be described below with respect to Figures 7 to 12 In various embodiments, overlapping thermal heating zones may result in a greater increase in temperature than non-overlapping thermal heating zones.

[0166] The user interface 102 may display a thermal heating zone extending in a radial direction away from the center point of the cancer therapy stimulation lead around the cancer therapy stimulation lead. In some embodiments, the temperature of the thermal heating zone may be between 36°C and 48°C. In some embodiments, the temperature may be greater than or equal to 36°C, 37°C, 38°C, 39°C, 40°C, 41°C, 42°C, 43°C, 44°C, 45°C, 46°C, 47°C, or 48°C, or an amount within a range between any of the foregoing values).

[0167] In various embodiments, the thermal heating zone modeled by the medical visualization system can be approximated using various methods. In some embodiments, the medical visualization system can approximate the thermal heating zone using a lookup table scaled with current tissue density values, duty cycle, tissue type, and geometry data. In some embodiments, the medical visualization system can approximate the thermal heating zone using electric field strength calculated in conjunction with tissue properties.

[0168] The thermal heating zones described herein may be modeled at a delivered power of 0.1 Watt (W) to 20 W or more, 0.1 Watt (W) to 15 W, 0.1 Watt (W) to 10 W, 0.1 Watt (W) to 7.5 W, 0.1 Watt (W) to 5 W, 2 Watt (W) to 5 W, etc. In some embodiments, the thermal heating zones described herein may be modeled at a delivered power greater than or equal to 0.10 W, 0.35 W, 0.60 W, 0.85 W, 1.10 W, 1.35 W, 1.50 W, 2 W, 2.5 W, 3 W, 3.5 W, 4 W, 5 W, 7.5 W, 10 W, 12.5 W, 15 W, 17.5 W, 20 W, or an amount within a range between any of the foregoing values.

[0169] In some embodiments, the medical visualization system may be configured to allow the user to manipulate the position of one or more cancer therapy stimulation leads, and the medical visualization system 100 may recalculate the positions and values ​​of the electric field strength zones 208 and the thermal heating zones 300. The user interface 102 may be updated during such recalculation to display the new position data of the cancer therapy stimulation leads as manipulated by the user. The user interface 102 may also be updated during such recalculation to display the new and updated electric field strength and / or thermal heating zone information.

[0170] In some embodiments, the medical visualization system may be configured to allow a user to mark a point of interest and view the temperature of the thermal heating zone at that point. For example, the system may be configured to allow a user to select a specific point or structure (using, for example, a mouse, a pen input device, a touch screen, etc.) and view (such as via a pop-up box or text field or graphical object) the temperature associated with that particular point or structure of interest.

[0171] It should be understood that in various embodiments, the medical visualization system can be configured to display both the thermal heating zone and the electric field strength associated with the cancer treatment stimulation lead. By having the medical visualization system simultaneously present both the thermal heating zone and the electric field strength, the user can use the modeling data associated with the thermal heating zone and the electric field strength to improve the placement of the stimulation lead to obtain optimal placement. Additionally, the user can also visualize how improving the placement of the stimulation lead affects both the thermal heating zone and the electric field strength.

[0172] The medical visualization system 100 can be configured to present a three-dimensional model with multiple cancer treatment stimulation leads on a user interface. Figure 4 , shows a schematic diagram of a user interface 102 showing an embodiment with placement of cancer treatment stimulation leads 400, 402, and 404 according to various embodiments herein. The user interface 102 may include the above reference Figure 2 and Figure 3 The user interface 102 may include a portion of a three-dimensional representation of the subject's anatomy, including the brain 112 and the skull 406 .

[0173] As described above, the medical visualization system can calculate optimal placement of one or more cancer therapy stimulation leads, and the user interface 102 can display the locations of the cancer therapy stimulation leads and any corresponding electric field strengths (indicated by dashed lines surrounding each cancer therapy stimulation lead 400, 402, and 404). In some embodiments, the medical visualization system can calculate the optimal locations of the cancer therapy stimulation leads 400, 402, and 404 around the cancerous tumor 202. In other embodiments, such as those described herein, Fig.18 As shown, the medical visualization system can calculate optimal placement of cancer therapy stimulation leads 400, 402, and 404 within or around a tumor resection site or cavity.

[0174] In some embodiments, cancer therapy stimulation leads 400, 402, and 404 may be positioned in an area containing a cancerous tumor 202. In some embodiments, cancer therapy stimulation leads 400, 402, and 404 may be positioned around a central point of a cancerous tumor 202. In other embodiments, cancer therapy stimulation leads 400, 402, and 404 may be positioned around a non-central point of a cancerous tumor 202. In some embodiments, cancer therapy stimulation leads may be positioned around the circumference of a cancerous tumor.

[0175] In various embodiments, the cancer therapy stimulation leads herein may be placed 70 to 120 degrees apart from each other relative to the center point of the cancerous tumor 202. In various embodiments, the cancer therapy stimulation therapy leads may be positioned around the cancerous tumor at intervals greater than or equal to 70, 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, or 180 degrees relative to each other, or an amount that may fall within a range between any of the foregoing values. For example, Figure 4 The cancer therapy stimulation leads 400, 402, 404 in FIG. 2 are shown as being positioned at 120 degrees around the center point of the cancerous tumor 202. In some embodiments, the cancer therapy stimulation leads may be equally spaced around the center point of the cancerous tumor. In other embodiments, the cancer therapy stimulation leads may be unequally spaced around the center point of the cancerous tumor. In various embodiments, one or more cancer therapy stimulation leads may be positioned within the cancerous tumor.

[0176] In some embodiments, the user interface 102 may be configured to display a top view or a bird's eye view of the three-dimensional model. Alternatively, the user interface 102 may also be configured to display a side view or a perspective view of the three-dimensional model. Figure 5 , shows a schematic diagram of a user interface 102 of an embodiment showing placement of a cancer treatment stimulation lead according to various embodiments herein. Figure 5 In the illustrated embodiment, the user interface 102 includes a side view of cancer therapy stimulation leads 400, 402, and 404, wherein each cancer therapy stimulation lead includes two electric field generating electrodes 502 disposed along the length of the cancer therapy stimulation lead. Each cancer therapy stimulation lead includes a proximal and a distal electric field generating electrode. It should be understood that each cancer therapy stimulation lead may include one or more electric field generating electrodes. The cancer therapy stimulation leads and the electric field generating electrodes disposed thereon will be discussed in more detail below.

[0177] Figure 5 The side view shown also includes placing cancer therapy stimulation leads 400, 402, and 404 in appropriate locations around the cancerous tumor 202 and within the entry point of the burr hole 500 on the subject's skull 406. The medical visualization system can be configured to utilize a three-dimensional model of the subject's anatomy to provide placement of one or more burr holes in the subject's skull to optimize placement of one or more cancer therapy stimulation leads at the cancerous tumor in the brain. It should be understood that in some embodiments, one burr hole can be used with one or more (e.g., one, two, three, or more) leads and / or electrodes. In some embodiments, multiple burr holes can each be used with one or more (e.g., one, two, three, or more) leads and / or electrodes.

[0178] In various embodiments, the user interface 102 may also include biographical and biometric data, which may include personal information and device information, such as an identification number, a device model, the number of cancer therapy stimulation leads in the user interface, the viewing angle of the user interface, the temperature of the cancer therapy stimulation leads, the electric field strength of the cancer therapy stimulation leads, and the coordinates of the cancer therapy stimulation leads.

[0179] In various embodiments, the user interface 102 may display multiple views of the treatment at one time. Figure 6 , shows a schematic diagram of a user interface 102 showing multiple views of placement of a cancer treatment stimulation lead according to various embodiments herein. The user interface 102 may include, for example, Figure 5 The user interface 102 may also include various zoomed-in views 600 and 602. Zoomed-in view 600 may include a more detailed view of the cancer therapy stimulation lead 400 and its placement in the treatment area. Zoomed-in view 602 may include a more detailed view of the cancer therapy stimulation lead 404 and its placement in the treatment area. It should be understood that the user interface 102 may be configured to switch between any number of cancer therapy stimulation leads 400, 402, and 404. The user interface 102 may also include a vertical view 604 that includes features of a main view 606 rotated 90 degrees relative to the main view 606.

[0180] The user interface 102 may include various interactive command interface objects, including tabs 608, 610, 612, and 614. The command interface objects may include various elements that a user may interact with in the user interface 102 to manipulate views, change parameters, and add various effects. The command interface objects may include, but are not limited to, buttons, menu trees, menu bars, ratio buttons, slide bars, dials, pointers, cursors, etc. For example, a user may manipulate a three-dimensional model using a user interface device that may be used to interact with the various command interface objects, such as a keyboard and / or a mouse. User engagement or actuation of the command interface objects may perform various actions or functions on the user interface 102.

[0181] The user interface 102 may be configured to be manipulated by the user so that various visualization components may be turned off or on. The visualization components may include the subject's anatomical structures, including the brain 112, the skull 406, the cancerous tumor 202, the cancer therapy stimulation wires 400, 402, and 404, and various key structures. For example, the user may turn off portions of the subject's anatomical structures, including the brain 112 and the skull 406, while leaving the cancerous tumor 202 and the cancer therapy stimulation wires 400, 402, and 404 open. Alternatively, the user may turn off the subject's anatomical structures and the cancerous tumor 202, while leaving the cancer therapy stimulation wires 400, 402, and 404 and any key structures that may be present open. In some embodiments, the user interface 102 may allow the user to quickly navigate between various views with different visualization components turned on and off.

[0182] Figures 7 to 12 Included are exemplary cancer therapy stimulation lead placements, wherein various numbers of cancer therapy stimulation leads are shown positioned within the region of a cancerous tumor or within a tumor resection site or region. Figure 7 , a top view of a graphical representation of the placement of three cancer therapy stimulation leads in the region of a cancerous tumor according to various embodiments herein is shown. The cancer therapy stimulation leads 700, 702, and 704 may be positioned approximately 120 degrees apart from each other around a center point of the cancerous tumor 202 (or a tumor resection site). Each cancer therapy stimulation lead may be modeled to generate an electric field strength zone 208 around the circumference of the lead. In various embodiments, each of the cancer therapy stimulation leads 700, 702, and 704 may include an electric field strength zone 208 that may overlap at least a portion of the cancerous tumor 202 or the tumor resection site. In various embodiments, each of the cancer therapy stimulation leads 700, 702, and 704 may include an electric field strength zone 208 that may overlap an adjacent electric field strength zone 208.

[0183] Reference now Figure 8 , shows a top view of a graphical representation of the placement of four cancer therapy stimulation leads in the area of ​​a cancerous tumor in accordance with various embodiments herein. The cancer therapy stimulation leads 800, 802, and 804 are positioned approximately 120 degrees apart from one another about a center point of the cancerous tumor 202 (or a tumor resection site). Each cancer therapy stimulation lead may be modeled to generate an electric field strength zone 208 around the circumference of the lead. In various embodiments, each of the cancer therapy stimulation leads 800, 802, and 804 may include an electric field strength zone 208 that may overlap at least a portion of the cancerous tumor 202 or the tumor resection site. In various embodiments, each of the cancer therapy stimulation leads 800, 802, and 804 may include an electric field strength zone 208 that may overlap an adjacent electric field strength zone 208. Additionally, in Figure 8In the illustrated embodiment, a fourth cancer therapy stimulation lead 808 may be positioned within the cancerous tumor 202 or a tumor resection site.

[0184] Reference now Fig. 9 , shows a top view of a graphical representation of the placement of two cancer therapy stimulation leads in the region of a cancerous tumor according to various embodiments herein. The two cancer therapy stimulation leads 900 and 902 may be positioned approximately 180 degrees apart from each other around a center point of the cancerous tumor 202 such that the electric field strength zones 208 of both the cancer therapy stimulation leads 900 and 902 overlap. Each cancer therapy stimulation lead may be modeled to generate an electric field strength zone 208 around the circumference of the lead. In various embodiments, each of the cancer therapy stimulation leads 900 and 902 may include an electric field strength zone 208 that may overlap at least a portion of the cancerous tumor 202 or a tumor resection site. In various embodiments, each of the cancer therapy stimulation leads 900 and 902 may include an electric field strength zone 208 that may overlap an adjacent electric field strength zone 208.

[0185] Reference now Fig.10 , a top view of a graphical representation of the placement of a single cancer therapy stimulation lead in the region of a cancerous tumor according to various embodiments herein is shown. The cancer therapy stimulation lead 1000 may be positioned in the region of the cancerous tumor 202 or in a tumor resection site. In various embodiments, a portion of the electric field intensity zone 208 generated by the cancer therapy stimulation lead overlaps a portion of a subject's bone 1002. The medical visualization system may be configured to accept input from a user to change the positioning of the cancer therapy stimulation lead 1000 by moving it away from the portion of the subject's bone 1002. Alternatively, the medical visualization system 100 may provide a notification to the user that the cancer therapy stimulation lead 1000 is adjacent to the portion of the subject's bone 1002, thereby allowing the user to interact with the system to reposition the cancer therapy stimulation lead 1000 as needed. Use of the notification by the medical visualization system will be described in more detail below.

[0186] Reference now Fig.11, a top view of a graphical representation of the placement of two cancer therapy stimulation leads in the region of a cancerous tumor 202 according to various embodiments herein is shown. Cancer therapy stimulation leads 1100 and 1102 may be positioned in the region of the cancerous tumor 202. Cancer therapy stimulation lead 1102 may be positioned adjacent to a portion of a subject's bone 1002. In various embodiments, the cancer therapy stimulation lead may include one or more insulated or partially insulated directional electric field generating electrodes, such as insulated or partially insulated electric field generating electrode 1104, to manipulate the electric field strength region 208 in a direction away from healthy tissue and toward the cancerous tumor 202 or a tumor resection site. In various embodiments, the insulated electric field generating electrodes may be presented by the medical visualization system to show the induced directionality of the field strength. It should be understood that the effect of the insulated or partially insulated directional electrodes varies with size. Typically, small diameter electrodes will have little effect. In various embodiments, the system may also model the effect of longitudinal segmentation of the electrodes. For example, the system may model the effect of different amounts of longitudinal segmentation of the electrodes to enable visualization and enable the user to manipulate the field distribution.

[0187] In various embodiments, at least one electrode may include a shield (such as a shield that shields against electric fields and / or heat), wherein the shield may be configured to shape the electric field generated by the electric field generating electrode. The shield may take the form of an insulating material or a separate component. For example, an electric field shaping element (not shown) may be implanted with the cancer treatment stimulation lead 1102, wherein the electric field shaping element may be configured to shape the electric field intensity zone 208 and direct it away from the subject's bone 1002 and toward the cancerous tumor 202. Exemplary electric field shaping elements are disclosed in commonly owned U.S. Publication No. 2019 / 0117972, filed on October 22, 2018, which is incorporated herein by reference in its entirety.

[0188] Reference now Fig.12, a top view of a graphical representation of the placement of two cancer treatment stimulation leads and auxiliary electric field generating electrodes in the region of a cancerous tumor according to various embodiments herein is shown. Cancer treatment stimulation leads 1200 and 1202 are positioned in the region of a cancerous tumor 202 or in a tumor resection site. Additional auxiliary electric field generating electrodes 1204 may be positioned on the opposite side of the skull of a subject in the region of a cancerous tumor 202 or in a tumor resection site to provide a supplemental electric field strength zone 208 to the treatment site where a supplemental electric field strength zone 208 is needed or where in other cases, it may be difficult to reach the tumor. In some embodiments, the auxiliary electric field generating electrodes 1204 may be positioned subcutaneously. In various embodiments, the auxiliary electric field generating electrodes 1204 may be positioned percutaneously. In other embodiments, the auxiliary electric field generating electrodes 1204 may be positioned externally, such as in the context of a patch-type electrode. In some embodiments herein, even the leads may be omitted, and all electrodes may be external, such as in the context of a patch-type electrode. In some embodiments, some of the electrodes may be implanted (on the leads or at other locations), and some of the electrodes may be external. In some embodiments, all electrodes may be internal (on the leads or at other locations).

[0189] Reference now Fig.13 , a schematic diagram of a graphical representation of the placement of various cancer treatment stimulation wires in the area of ​​a cancerous tumor according to various embodiments of the present invention is shown. Each of the cancer treatment stimulation wires 1300, 1302, and 1304 includes two electric field generating electrodes (e.g., a proximal electrode 1306 and a distal electrode 1308). However, it should be understood that in some embodiments, a greater number or a lesser number of electrodes may be used. In some embodiments, each of the cancer treatment stimulation wires 1300, 1302, and 1304 may include a different number of electrodes from each other. For example, each cancer treatment stimulation wire may include one electrode, two electrodes, or a combination thereof. The cancer treatment stimulation wires 1300, 1302, and 1304 are arranged in close proximity to the cancerous tumor 202 or the tumor resection site. The electric field can be visualized along various stimulation vectors (paths of tissue / tumors that interconnect two different electrodes) through the coil electrode.

[0190] Each cancer therapy stimulation lead 1300, 1302, and 1304 can generate an electric field strength region 208 around the longitudinal axis of the cancer therapy stimulation lead. The electric field strength region 208 can be shaped like an hourglass, a cylinder, etc. The electric field strength region of the cancer therapy stimulation lead can be centered around the electric field generating electrodes 1306 and 1308.

[0191] Cancer Treatment Stimulation Leads

[0192] Reference now Fig.14, shows a schematic diagram of a cancer therapy stimulation lead 1400 according to various embodiments of the present invention. The cancer therapy stimulation lead 1400 may include a lead body 1402 having a proximal end 1404 and a distal end 1406. In this example, a first electrode 1408 and a second electrode 1409 are coupled to the lead body 1402, such as being positioned near its distal end 1406. In some embodiments, the electrodes 1408, 1409 may include electric field generating electrodes. In various embodiments, the electrodes 1408, 1409 may include electric field sensing electrodes. The electrodes 1408, 1409 may be internally connected or internally independent. In the example where the electrodes 1408, 1409 are independent, the system of the present invention may model each as an independent field and heat source. The lead body 1402 may define a cavity. The electrodes 1408, 1409 may include various conductive materials, such as platinum, silver, gold, iridium, titanium, and various alloys. In some embodiments, the cancer therapy stimulation lead 1400 includes more than two electrodes.

[0193] The cancer therapy stimulation lead 1400 may include one or more thermistors disposed along the length of the cancer therapy stimulation lead. The thermistors may be used to measure thermal heating around the cancer therapy stimulation lead to provide feedback to the clinician regarding localized thermal heating zones around the lead. In some embodiments, thermistor data may be recorded and subsequently compared to modeled thermal data to enhance the modeling function or algorithm, or to improve the accuracy of thermal modeling.

[0194] The cancer therapy stimulation lead 1400 may also include terminal pins 1410 for connecting the cancer therapy stimulation lead 1400 to an implantable device, such as a cancer therapy device. The terminal pins 1410 may be compatible with various lead-header interface design standards, including DF-1, VS-1, IS-1, LV-1, and IS-4 standards, as well as other standards.

[0195] In some embodiments, the cancer therapy stimulation lead 1400 may further include a fixation element 1412, such as an element that may be adhered to a part of the subject's body to maintain the position of the cancer therapy stimulation lead 1400 and / or the electrode 1408. In various embodiments, the fixation element 1412 may be disposed along the distal end 1406 of the cancer therapy stimulation lead 1400. However, in some embodiments, the fixation element 1412 is omitted.

[0196] Reference now Fig.15 , showing how to follow the various embodiments according to this document Fig.14Schematic diagram of a cross-section of a cancer therapy stimulation lead 1400 taken along line 6-6′ of FIG. Cancer therapy stimulation lead 1400 may include an outer layer 1500 having an outer surface 1502. Outer layer 1500 may be flexible and may be configured to protect other components disposed within a cavity of outer layer 1500. In some embodiments, outer layer 1500 may be circular in cross-section. In some embodiments, outer layer 1500 includes a dielectric material and / or an insulator. In some embodiments, outer layer 1500 may include various biocompatible materials, such as polysiloxane, polyethylene, polyamide, polyurethane, and the like.

[0197] In various embodiments, the cancer therapy stimulation lead 1400 may include one or more conductors, such as a first conductor 1504 and a second conductor 1506. In some embodiments, the first conductor 1504 and the second conductor 1506 may be disposed within a lumen of the outer layer 1500. The first conductor 1504 and the second conductor 1506 may be configured to provide electrical communication between the electrode 1408 and the proximal end 1404 of the cancer therapy stimulation lead 1400. The first conductor 1504 and the second conductor 1506 may include various materials, including copper, aluminum, silver, gold, and various alloys, such as tantalum / platinum, MP35N, etc. Insulators 1508 and 1510 may surround the first conductor 1504 and the second conductor 1506. The insulators 1508 and 1510 may include various materials, such as electrically insulating polymers.

[0198] In some embodiments, each of the electrodes 1408 may have a separate first conductor 1504 and a second conductor 1506 to electrically couple the electrode 1408 to the proximal end 1404 of the cancer therapy stimulation lead 1400. However, in some embodiments, each of the electrodes 1408 is connected to only a single conductor to electrically couple the electrode 1408 to the proximal end 1404 of the cancer therapy stimulation lead 1400. In some embodiments, the first conductor 1504 and the second conductor 1506 may be configured as a coil or cable. Multiple conductors may be disposed within the cavity of the outer layer 1500. For example, a separate conductor or a group of conductors may communicate with each electrode disposed along the lead. In various embodiments, the first conductor 1504 and the second conductor 1506 may form a portion of a circuit through which an electric field from an electric field generating circuit is delivered to a site of cancer tissue. Within the embodiments herein, more than one conductor may be included. Fig.15 For example, the cancer therapy stimulation lead 1400 can include 1, 2, 3, 4, 5, 6, 7, 8, 10, 15, or 20 or more conductors, or any number of conductors falling within a range between any of the foregoing values.

[0199] In some embodiments, the cancer therapy stimulation lead 1400 may include a central channel 1512. The central channel 1512 may be configured to pass a lead or other implanted device, such as to facilitate implantation of the cancer therapy stimulation lead 1400 and the electrode 1408. In some cases, additional channels (not shown) are provided within the cancer therapy stimulation lead 1400.

[0200] Characteristics of Medical Visualization Systems

[0201] In one embodiment, a medical visualization system is included. The medical visualization system may include video processing circuitry, central processing circuitry in communication with the video processing circuitry, and communication circuitry in communication with the central processing circuitry. The medical visualization system may also include a user interface generated by the video processing circuitry. The user interface may include a three-dimensional model of at least a portion of an anatomical structure of a subject observed from a first perspective. The first perspective may be configured to be controlled by a user.

[0202] The medical visualization system herein can be configured to display various information to the user. In some embodiments, the medical visualization system can be configured to present information on a user interface that informs the user of the electric field strength. In some embodiments, the medical visualization system can be configured to present information on a user interface that informs the user to place one or more additional cancer treatment stimulation leads to increase the field strength, optimize the field strength to cover the target area for treatment, optimize the field strength according to an acceptable heating level, etc.

[0203] In some embodiments, the medical visualization system may be configured to present information on a user interface that notifies a user when at least one cancer therapy stimulation lead is placed within a threshold or distance of a critical structure. These thresholds or distances may be set by a system user and / or may be preset within the system. In some embodiments, the medical visualization system may be configured to present information on a user interface that notifies a user of a critical structure, such as a critical anatomical structure, including at least one selected from the group consisting of a bone, a pituitary gland, a blood vessel, a hypothalamus, a ventricle, a brainstem, amygdala, thalamus, cerebellum, and a corpus callosum, or other structures that may be specified by a user or preset within the system.

[0204] In various embodiments, the medical visualization system can be configured to present an area of ​​interest to a user, which can include a surgical access site, a lead implant site, such as, for example, a burr hole or a proposed placement of multiple burr holes for inserting one or more cancer therapy stimulation leads. In some embodiments, the medical visualization system can be configured to present information on a user interface that includes a graphical representation of the placement of burr holes within a subject's skull. In various embodiments, the graphical representation of the burr holes provides a graphical representation of optimal burr hole placement. In one embodiment, the visual burr hole representation is shown as being at least 0.25 inches in diameter. In one embodiment, the visual burr hole representation is shown as being approximately 0.625 inches in diameter.

[0205] In some embodiments, a medical visualization system may be configured to present information on a user interface, the information comprising a visual lead trajectory, wherein the visual lead trajectory provides a graphical representation of an optimal trajectory of at least one cancer therapy stimulation lead.

[0206] In some embodiments, the medical visualization system may be configured to present information on a user interface, the information comprising a visual thermal representation of at least a portion of an anatomical structure of a subject, wherein the visual thermal representation of at least a portion of an anatomical structure of the subject is associated with a three-dimensional model. In some embodiments, the medical visualization system is configured to present information to a user, the information showing that the visual thermal representation of at least a portion of an anatomical structure of the subject estimates the temperature throughout the three-dimensional model (which may be a portion of a particular anatomical structure or body part or may be all of an anatomical structure or body part - such as an entire head or an entire brain, etc.).

[0207] In some embodiments, the medical visualization system may be configured to display electrode locations to provide treatment based on the location of a cancerous tumor or a tumor resection site. In some embodiments, the medical visualization system is configured to present information to a user that displays placement of one or more cancer treatment stimulation leads based on the location of a cancerous tumor or a tumor resection site. In some embodiments, the medical visualization system is configured to present information to a user that displays placement of one or more electrodes based on the location of a cancerous tumor or a tumor resection site.

[0208] In addition to cancerous tumors and tumor resection sites, it should be understood that the systems herein can also be used to visualize aspects of electric field therapy with respect to contrast enhanced volumes / regions / areas.

[0209] In some embodiments, the medical visualization system is configured to present information to a user that displays predetermined treatment parameters including a duty cycle based on the location of the cancerous tumor or tumor resection site. In some embodiments, the medical visualization system is configured to present information to a user that displays one or more treatment vector patterns between electrodes.

[0210] In some embodiments, a medical visualization system includes an apparatus including a graphical display and a machine-readable medium including instructions. When executed by one or more processors, the instructions may perform various operations. For example, the operations may include those according to the methods or operations described herein. The machine-readable medium may include a random access memory (RAM), a read-only memory (ROM), a magnetic data storage medium, an optical data storage medium, a flash memory, etc.

[0211] An apparatus for displaying a three-dimensional model of at least a portion of an anatomical structure of a subject and / or a user interface thereof may include various components. Fig.16 , a diagram showing various components according to some embodiments. The medical visualization system may include central processing circuitry, which may include various components, such as a central processing unit. By way of example, the medical visualization system may include a central processing unit (CPU) 1605 or processor, which may include a conventional microprocessor, a random access memory (RAM) 1610 for temporary storage of information, and a read only memory (ROM) 1615 for permanent storage of information. A memory controller 1620 is provided for controlling the system RAM 1610. A bus controller 1625 is provided for controlling a data bus 1630, and an interrupt controller 1635 is provided for receiving and processing various interrupt signals from other system components.

[0212] Mass storage may be provided by a magnetic or flash memory drive 1641 including removable or non-removable media connected to bus 1630 by controller 1640; an optical drive, such as a CD-ROM or DVD drive 1646, connected to bus 1630 by controller 1645; and / or a hard disk drive 1651 (magnetic or solid state) connected to bus 1630 by controller 1650. In some embodiments, mass storage may be provided by a device connected via a Universal Serial Bus (USB), eSATA, FireWire, or Thunderbolt interface, or other type of connection. User input to the programmer system may be provided by a variety of devices. For example, a keyboard and mouse may be connected to bus 1630 by keyboard and mouse controller 1655. A DMA controller 1660 is provided for performing direct memory access to system RAM 1610. In some embodiments, user input may be provided by a pen, light pen, glove, wearable object, gesture control interface, etc.

[0213] Video processing circuitry may be included and may generate a user interface. The video processing circuitry may include a video controller 1665 or video output that controls a video display 1670. In some embodiments, the video controller 1665 may also include one or more graphics processing units (GPUs). The video processing circuitry may communicate with a central processing circuit.

[0214] The medical visualization system may also include a communication interface 1690 or communication circuitry that allows the system to interface with other systems and / or servers and exchange data. The communication circuitry may communicate with the central processing circuitry. In some embodiments, the communication interface 1690 may include a network interface card or circuitry to facilitate communication with a packet-switched (such as IP) or other type of data network.

[0215] It should be understood that some embodiments may lack Fig.16 In addition, Fig.16 The architecture shown in is just one example of how the discrete components may be arranged, and other architectures are expressly contemplated herein.

[0216] In addition to related Fig.16 In addition to or in lieu of the components described above Fig.16 As with the components described, it should be understood that the system may also include a microcontroller, a programmable logic controller (PLC), an ASIC, an FPGA, a microprocessor or other suitable technology.

[0217] The video processing circuit (local or on a remote node) can generate a 3D (or less or more dimensional) image based on information including one or more of the geometry, perspective, texture, lighting and shadow information and the above-mentioned other information. In some embodiments, the information for rendering the image is combined in a scene file. The term "graphics pipeline" can be used to refer to a series of steps for creating a 2D raster representation of a 3D scene. The video processing circuit can perform one or more steps of the graphics pipeline. The video processing circuit can also include one or more physical components for the graphics pipeline. Using the above information, the graphics pipeline may include one or more stages of creating scenes from geometric primitives, modeling and transformation, camera transformation, lighting, projection transformation, shearing, scan conversion or rasterization, and texture and fragment shading. In various embodiments, other operations may also be performed. In various embodiments, the graphics pipeline may use OpenGL, DirectX or other protocols.

[0218] method

[0219] Many different methods are contemplated herein, including, but not limited to, methods of manufacture, methods of use, etc. Aspects of the system / device operations described elsewhere herein may be performed as operations of one or more methods according to various embodiments herein.

[0220] Reference now Fig.17 , in one embodiment, includes a method 1700 for visualizing placement of a cancer therapy lead. The method may include obtaining three-dimensional imaging data of a region of tissue at or near a cancerous tumor or a tumor resection cavity at 1702. The method may also include generating a predetermined model using the three-dimensional data at 1704. The predetermined model is configured to assign one or more electrical properties to a region of tissue. The method also includes positioning one or more cancer therapy stimulation leads within the predetermined model at 1706 in the region of tissue at or near a cancerous tumor or a tumor resection cavity. The method also includes calculating one or more electric fields to the region of tissue at or near a cancerous tumor or a tumor resection cavity at 1708, and superimposing one or more electric field lines on the predetermined model.

[0221] In one embodiment, the method may further include calculating one or more temperatures of a region of tissue at or near the cancerous tumor or tumor resection cavity and superimposing one or more temperature contours onto the predetermined model.

[0222] In one embodiment, the predetermined model is configured to predict changes in a tissue region over a period of time.

[0223] In one embodiment, the change is caused by a void or tissue swelling left by the removal of a cancerous tumor.

[0224] In one embodiment, one or more electrical properties are assigned based on the type of tissue.

[0225] In one embodiment, the type of tissue includes at least one selected from the group consisting of cancerous tissue, muscle, bone, and healthy tissue.

[0226] In one embodiment, the method further comprises setting a maximum temperature limit for healthy tissue.

[0227] In one embodiment, the method further comprises setting a maximum temperature limit for the cancerous tissue.

[0228] In one embodiment, the method further comprises setting a minimum electric field strength.

[0229] In one embodiment, one or more cancer therapy stimulation leads are independently controlled.

[0230] In one embodiment, one or more cancer therapy stimulation leads include one or more electrodes.

[0231] In one embodiment, one or more cancer therapy stimulation leads may include components that can be used to measure temperature. For example, in some embodiments, the cancer therapy stimulation leads may include a thermistor, a thermocouple, a resistance temperature detector, a semiconductor junction-based temperature measurement component, etc.

[0232] In one embodiment, the one or more cancer therapy stimulation leads include a thermal gradient and a therapy gradient extending outwardly from the one or more cancer therapy stimulation leads.

[0233] In one embodiment, the three-dimensional imaging data is obtained using magnetic resonance imaging data or computed tomography data.

[0234] notify

[0235] In one embodiment, the medical visualization system may include a notification system that presents one or more notifications to a user in a user interface. The notification system may notify the user of various matters. For example, the notification system may warn the user when a cancer treatment stimulation lead is in close proximity to one or more critical structures, such as a bone, nerve, pituitary gland, blood vessel, hypothalamus, ventricle, brain stem, amygdala, thalamus, cerebellum, or corpus callosum.

[0236] Additionally, the notification system can alert the user when the electric field strength region generated by the cancer therapy stimulation lead decreases and / or increases the electric field strength based on a preset strength or when the electric field strength falls within a threshold value. Similarly, the notification system can alert the user when the cancer therapy stimulation lead or surrounding tissue decreases and / or increases the temperature based on a preset temperature or when the temperature exceeds a threshold value or falls within a threshold value.

[0237] The notification system can indicate to the user when placement of one or more additional cancer therapy stimulation leads or one or more additional electrodes may be required to enhance the electric field strength. The one or more additional electrodes can be selected from the group consisting of a subcutaneous electrode, a subcranial electrode, and an external electrode.

[0238] The notification system can use various ways to notify the user of any of the above situations. For example, the notification system can provide a pop-up alert on the user interface. The notification system can provide an audible alert. The notification system can provide a texture and / or color change in the user interface's graphical representation of the cancer therapy stimulation lead, the subject's anatomy, critical structures, and / or cancerous tumor.

[0239] Tumor resection cavity

[0240] As previously discussed, the medical visualization system can be configured to provide optimal placement of one or more cancer treatment stimulation leads and can provide a graphical representation of the electric field zones at the lead placement sites superimposed on a three-dimensional model. The area being treated can be a cancerous or non-cancerous tumor, a tumor resection site, area or cavity (such as to prevent cancer recurrence), a precancerous lesion, area, contrast-enhancing tissue, such as proximal to a resection or tumor, or other tissue areas of concern or risk or other cancer or related or non-related conditions. Reference is now made to Fig.18, which is a graphical representation of an electric field strength region 208 associated with cancer therapy stimulation leads 204 and 206 positioned at a treatment site. The treatment site may include an area 1800 that includes a tumor resection cavity or other target tissue for treatment. The user interface 102 may display a graphical representation of at least one cancer therapy stimulation lead positioned at a treatment site within a three-dimensional model of the subject's anatomy. Fig.18 In the illustrated embodiment, two cancer therapy stimulation leads 204 and 206 are present on opposite sides of region 1800. In some embodiments, cancer therapy stimulation leads 204, 206 can be positioned within region 1800. In other embodiments, cancer therapy stimulation leads 204, 206 can be positioned around region 1800 within the treatment site. Fig.18 Two cancer therapy stimulation leads are shown, but it should be understood that in some embodiments, the user interface 102 can display 1 to 5 cancer therapy stimulation leads. In various embodiments, the user interface 102 can display 1, 2, 3, 4, or 5 cancer therapy stimulation leads. In various embodiments, more than 5 cancer therapy stimulation leads can be used.

[0241] The graphical representation of the electric field strength region 208 may include one or more electric field strength gradients as represented by electric field strengths 210, 212, 214, 216, 218, and 220 that decrease in strength in a radial direction away from the center of the cancer therapy stimulation lead 204. It should be understood that each cancer therapy stimulation therapy lead in the graphical representation may include an electric field strength gradient. In various embodiments, each cancer therapy stimulation therapy lead may include the same electric field strength gradient. In various other embodiments, each cancer therapy stimulation therapy lead may include a different electric field strength gradient.

[0242] An electric field strength scale 222 including electric field strength values ​​may be included as a legend in the user interface 102 to identify the value of the electric field strength depicted on the display. Fig.18 The electric field strength in is represented as discrete areas within the electric field strength zone 208, but it should be understood that the intensity of the electric field strength may decrease in a diffuse gradient (or a continuous gradient) in a radial direction away from the center of the cancer treatment stimulation lead, rather than in discrete circular areas (or in a step gradient).

[0243] In various embodiments, the electric field strength modeled by the medical visualization system may be calculated using various methods and include various electric field strengths as previously described herein.

[0244] In some embodiments, the system may be configured to accept user input regarding a region of interest around a resection cavity site. For example, the user input may mark the resection cavity site (or this information may be pre-inserted) and specify a particular distance (such as 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 centimeters or more, or a number falling within a range between any of the foregoing values), and the calculated field strength within that region is then displayed by the medical visualization system. In that manner, the system may specifically highlight information about the field strength in the region of greatest interest to the clinician or other system user. In some embodiments, the system may be configured to display a field strength gradient within a region of interest. In some embodiments, the system may be configured to display an area within the region of interest where the field strength exceeds a threshold value (such as exceeding a minimum threshold value) as set by the user input.

[0245] Additionally, as previously discussed herein, the medical visualization system herein may also be configured to model the thermal heating zones associated with the cancer therapy stimulation leads, which may also be used to further improve the placement of the cancer therapy stimulation leads. In various embodiments, the average heat output is generally proportional to the electrode power multiplied by the duty cycle. Referring now to Fig.19 , shows a schematic diagram of a user interface 102 of an embodiment showing a graphical representation of a thermal heating zone according to various embodiments herein. The user interface 102 may include a three-dimensional model of at least a portion of an anatomical structure of a subject, such as a brain 112. The three-dimensional model of the anatomical structure of the subject may also include an area 1800, which may include a tumor resection site or cavity.

[0246] The user interface 102 may display a graphical representation of at least one cancer treatment stimulation lead positioned at a treatment site within the three-dimensional model of the subject's anatomy. Fig.19 In the illustrated embodiment, two cancer therapy stimulation leads 204 and 206 are present on opposite sides of the treatment area 1800. Fig.19 Two cancer therapy stimulation leads are shown, but it should be understood that in some embodiments, the user interface 102 can display 1 to 5 cancer therapy stimulation leads. In various embodiments, the user interface 102 can display 1, 2, 3, 4, or 5 cancer therapy stimulation leads. In various embodiments, more than 5 cancer therapy stimulation leads can be used.

[0247] The medical visualization system herein may be configured to provide optimal placement of one or more cancer therapy stimulation leads and may provide a graphical representation of thermal heating zones at the lead placement sites superimposed on a three-dimensional model. Fig.19A virtual thermal heating zone 300 associated with the cancer therapy stimulation leads 204 and 206 is included. The graphical representation of the thermal heating zone 300 may include one or more thermal heating gradients including temperatures 310, 312, 314, 316, 318, and 320 whose intensity may decrease in a radial direction away from the center of the cancer therapy stimulation lead 204. It should be understood that each cancer therapy stimulation therapy lead in the graphical representation may include a thermal heating zone gradient. In various embodiments, each cancer therapy stimulation therapy lead may include the same thermal loading zone gradient. In various other embodiments, each cancer therapy stimulation therapy lead may include a different thermal loading zone gradient.

[0248] A temperature scale 324 may be included as a legend in the user interface 102 to identify the value of the temperature depicted on the display. Fig.19 The temperatures in are represented as discrete areas within the thermal heating zone 300, but it should be understood that the intensity of the temperature will decrease in a diffuse gradient (or continuous gradient) in a radial direction away from the center of the cancer treatment stimulation lead, rather than in different circular areas (or in a step gradient).

[0249] The user interface 102 may display a thermal heating zone extending in a radial direction away from the center point of the cancer therapy stimulation lead around the cancer therapy stimulation lead. In some embodiments, the temperature of the thermal heating zone may be between 36°C and 48°C. In some embodiments, the temperature may be greater than or equal to 36°C, 37°C, 38°C, 39°C, 40°C, 41°C, 42°C, 43°C, 44°C, 45°C, 46°C, 47°C, or 48°C, or an amount within a range between any of the foregoing values).

[0250] In various embodiments, the thermally heated zones modeled by the medical visualization system may be approximated using various methods, as discussed previously herein.The thermally heated zones may be modeled at various delivered powers, as discussed previously herein.

[0251] In some embodiments, the medical visualization system may be configured to allow the user to manipulate the position of one or more cancer therapy stimulation leads, and the medical visualization system 100 may recalculate the positions and values ​​of the electric field strength zones 208 and the thermal heating zones 300. The user interface 102 may be updated during such recalculation to display the new position data of the cancer therapy stimulation leads as manipulated by the user. The user interface 102 may also be updated during such recalculation to display the new and updated electric field strength and / or thermal heating zone information.

[0252] It should be understood that the heating effect is sensitive to the duty cycle of the treatment. Therefore, in various embodiments herein, the system can model the effect of the duty cycle on heating. For example, the system can receive input from the user regarding a specific duty cycle value and then apply it to the calculations herein (heating, field strength, etc.) to display the effect of the duty cycle setting to the user.

[0253] In some embodiments, the medical visualization system may be configured to allow a user to mark a point of interest and view the temperature of the thermal heating zone at that point. For example, the system may be configured to allow a user to select a specific point or structure (using, for example, a mouse, a pen input device, a touch screen, etc.) and view (such as via a pop-up box or text field or graphical object) the temperature associated with that particular point or structure of interest.

[0254] It should be understood that the medical visualization system can be configured to display both the thermal heating zone and the electric field strength associated with the cancer treatment stimulation lead. By having the medical visualization system simultaneously present both the thermal heating zone and the electric field strength, the user can use the modeling data associated with the thermal heating zone and the electric field strength to improve the placement of the stimulation lead to obtain optimal placement. Additionally, the user can visualize how improving the placement of the stimulation lead affects both the thermal heating zone and the electric field strength. Additionally, the user can improve the settings applied for the treatment, such as duty cycle settings, active electrodes, treatment stimulation vectors, vector switching modes, power, etc.

[0255] System Recommendations

[0256] The medical visualization system embodied herein can be configured to suggest one or more optimization parameters to a user. The medical visualization system can be configured to calculate the optimization parameters using one or more optimization functions or algorithms. The optimization function can include consideration of factors such as average field strength at the treatment site, calculated electric field strength at different locations within the treatment area, average temperature of the entire treatment area, calculated thermal heating zone of the entire treatment area, tissue density and type in and around the treatment site, location and type of critical structures in and around the treatment site, and location of the cancerous tumor or resection cavity to be treated.

[0257] The optimization function or algorithm used herein may include differentiable and non-differentiable objective functions (e.g., those using derivatives and those not using derivatives). The optimization function or algorithm herein may include, but is not limited to, first-order derivative methods, gradient methods, partial derivative methods, second-order derivative methods, methods based on Hessian matrices, bracket algorithms (such as Fibonacci search, golden section search, dichotomy), local descent algorithms, gradient descent algorithms, Newton's method, secant method, quasi-Newton's method, direct algorithms (including cyclic coordinate search, Powell's method, Hooketeff method, Ned-Mead simplex search), random algorithms (including simulated annealing, evolutionary strategies, cross entropy methods), and population algorithms (including genetic algorithms, differential evolution methods, particle swarm optimization, etc.).

[0258] In some embodiments, the medical visualization system can provide recommendations to the user based on one or more optimization functions. In some embodiments, the medical visualization system calculates optimal parameters to ensure that the subject's anatomy can be safely and effectively treated.

[0259] For example, the medical visualization system may suggest an optimal number of cancer therapy stimulation wires and / or electrodes for treating a cancerous tumor or a resection cavity. In some embodiments, the medical visualization system may display the optimal number of cancer therapy stimulation wires and / or electrodes to be used on a user interface. In other embodiments, the medical visualization system may use one or more of the notification methods previously described herein to notify the user of the optimal number of cancer therapy stimulation wires and / or electrodes to be used. In some examples, the optimal number of cancer therapy stimulation wires and / or electrodes may be sufficient to increase the field strength on the target area for treatment to at least a threshold number, sufficient to generate a field strength exceeding a threshold number on the target area for treatment in view of an acceptable heating level, etc. For example, in some embodiments, the system may perform an optimization function (such as those described herein) to determine whether the use of a particular number of wires (e.g., 2 vs. 3 vs. 4, etc.) provides a benefit in terms of the field strength (average or another measurement) achieved on the target area for treatment (such as a tumor resection site, a tumor, etc.) in view of the heating effect. For example, if the system determines that the use of 3 wires provides a benefit (such as a better average field strength on the target area or another benefit), the system may provide such a suggestion to the user, such as through an indication on the user interface. The target area for treatment may be specified by the user through a user interface and / or may be loaded from another device or system, or may be preset.

[0260] Similarly, in some embodiments, the system may perform an optimization function (such as those described herein) to determine whether using a particular number of electrodes on each lead (e.g., 1 vs. 2 vs. 3 vs. 4, etc.) provides a benefit in terms of field strength (average or another measure) achieved over a target area for treatment (such as a tumor resection site, a tumor, etc.) in view of the heating effect. For example, if the system determines that using a certain number of electrodes provides a benefit (such as a better average field strength over the target area or another benefit), the system may provide such a recommendation to the user, such as through an indication on a user interface.

[0261] In addition to the number of leads and / or electrodes, using similar optimization methods, the system herein may also make recommendations regarding the type of leads and / or electrodes to be used. For example, the system may make recommendations regarding the use of one or more additional leads / electrodes in the form of subcutaneous leads / electrodes, subcranial leads / electrodes, and external leads / electrodes. For example, in some cases, it may be recommended to use subcutaneous electrodes to enhance the field strength in the target area for treatment.

[0262] In some embodiments, the medical visualization system may suggest an optimal location for a cancer therapy stimulation lead at a treatment site. In some embodiments, the medical visualization system may display the optimal placement of a cancer therapy stimulation lead on a user interface. As previously described, the system may perform an optimization function (such as those described herein) to determine whether a particular placement of the lead provides a benefit, such as in terms of field strength (average or another measurement) achieved over a target area for treatment (such as a tumor resection site, a tumor, etc.) in view of the heating effect. For example, if the system determines that a particular placement of the lead provides a benefit (such as a better average field strength over the target area or another benefit), the system may provide such a suggestion to the user, such as through an indication on a user interface.

[0263] Additionally, the medical visualization system may suggest optimal placement of an implantable field generator (IFG) unit. For example, the medical visualization system may suggest a location within the subject's anatomy for safely implanting the IFG unit. In some embodiments, the medical visualization system may suggest implanting the IFG unit within the subject's brain. In other embodiments, the medical visualization system may suggest implanting the IFG unit further away from the cancer treatment stimulation lead, such as implanting the IFG unit in the subject's neck, chest, arm, or leg. In some embodiments, the system may perform optimization functions (such as those described herein) to determine whether a particular placement of the IFG provides sufficient space within the patient's particular anatomy or otherwise provides a benefit, such as in terms of field strength (average or another measurement) achieved on a target area for treatment (such as a tumor resection site, a tumor, etc.) in view of the heating effect.

[0264] In some embodiments, the medical visualization system may suggest a duty cycle timing or pattern for a cancer therapy stimulation lead. In some embodiments, the medical visualization system may suggest vectors and vector patterns between two or more electrodes. In some embodiments, the system may perform an optimization function (such as those described herein) to determine whether a particular duty cycle timing or pattern for a cancer therapy stimulation lead provides a benefit, such as in terms of the amount of tissue exposure to the treatment herein or in terms of the field strength (average or another measurement) achieved at a target area for treatment (such as a tumor resection site, a tumor, etc.) in view of the heating effect. For example, if the system determines that a particular duty cycle timing or pattern for a cancer therapy stimulation lead provides a benefit (such as a better average field strength at the target area, the total amount of exposure of the target area to the treatment, or another benefit), the system may provide such a suggestion to the user, such as through an indication on a user interface.

[0265] Trajectory of stimulation leads for cancer treatment

[0266] The medical visualization system embodied herein can be configured to provide a visual guidewire trajectory for each cancer therapy stimulation lead. The visual guidewire trajectory can provide a graphical representation of the optimal trajectory of the cancer therapy stimulation lead from the lead's entry point to the final placement. The visual guidewire trajectory can take into account the location of the cancerous tumor or resection cavity being treated, any critical structures that the cancer therapy stimulation lead may encounter during implantation, and the size and number of cancer therapy stimulation leads, among other things.

[0267] In some embodiments, the medical visualization system may suggest an optimal cancer therapy stimulation lead trajectory. The medical visualization system may use one or more of the optimization functions as previously described herein to suggest the optimal cancer therapy stimulation lead trajectory. For example, the system may model a series of different lead trajectories and then use the optimization function to determine the optimal lead trajectory in terms of average field strength over the target area for treatment in view of thermal effects (this is just one example). However, it should be understood that in addition to average field strength, the optimization may be performed in view of endpoints.

[0268] In many examples herein, the wires are shown as being parallel or substantially parallel to each other. However, it should be understood that non-parallel wire placement is also explicitly contemplated herein, and system modeling, operations, recommendations, outputs, etc. may be performed in the context of non-parallel wire placement.

[0269] Placement of burr holes

[0270] The medical visualization system may include a user interface having a visual burr hole representation that may provide a graphical representation of optimal burr hole placement for one, two, or more burr holes in the subject's head prior to surgery if a cancer therapy stimulation lead is to be implanted into the subject's brain to reach a cancerous tumor or resection cavity.

[0271] In one embodiment, the diameter of the graphical representation of the burr hole may be at least 0.25 inches. In some embodiments, the diameter of the graphical representation of the burr hole may be approximately 0.625 inches. Thus, the graphical representation of the burr hole may be approximately 0.25 inches in diameter, 0.333 inches in diameter, 0.5 inches in diameter, or 0.625 inches in diameter, or an amount within a range between any of the foregoing values.

[0272] In some embodiments, the medical visualization system may suggest an optimal burr hole placement. The medical visualization system may use one or more of the optimization functions as previously described herein to suggest the optimal burr hole placement. For example, the system may model a series of different burr hole placements and then use the optimization function to determine the optimal burr hole placement in terms of average field strength over the target area for treatment in view of thermal effects (this is just one example). However, it should be understood that the optimization may be performed in view of endpoints other than average field strength.

[0273] Anticipate MRI heating

[0274] The medical visualization system can be configured to provide an expected heating zone observed at the treatment site during an MRI. During an MRI procedure, heating occurs due to the time-varying radio frequency and gradient fields caused by the currents induced by the scanner. With continuous RF exposure and no heat dissipation, the local tissue temperature rises linearly in time with the RF power absorbed per exposed mass, i.e., the specific absorption rate (SAR). By applying one or more models to the SAR, the medical visualization system can calculate and provide a graphical representation of the expected thermal heating of the entire treatment site during an MRI. In some embodiments, the expected heating zone includes the expected thermal heating during an MRI when the subject has one or more cancer treatment stimulation leads implanted in the treatment site. The medical visualization system can take into account the location of the cancer treatment stimulation leads, the size and number of cancer treatment stimulation leads and electrodes implanted in and around the treatment site, and the type of tissue that may be affected in and around the treatment site.

[0275] It should also be noted that, as used in this specification and the appended claims, the phrase "configured to" describes a system, device, or other structure that is constructed or configured to perform a particular task or adopt a particular configuration. The phrase "configured to" may be used interchangeably with other similar phrases, such as arranged and configured, constructed and arranged, constructed, manufactured and arranged, etc.

[0276] All publications and patent applications in this specification are indicative of the common technical level in the field to which the invention pertains. All publications and patent applications are incorporated herein by reference to the same extent as if each individual publication or patent application was specifically and individually indicated by reference.

[0277] As used herein, the recitation of numerical ranges by endpoints shall include all numbers subsumed within that range (eg, 2 to 8 includes 2.1, 2.8, 5.3, 7, etc.).

[0278] The headings used herein are provided to be consistent with the recommendations under 37 CFR 1.77 or to otherwise provide organizational cues. These headings should not be considered to limit or characterize the invention set forth in any claims that may issue from this disclosure. As an example, although a heading mentions "field," such claims should not be limited to the language selected under that heading to describe the so-called technical field. In addition, the description of a technology in the "background" does not admit that the technology is prior art to any invention in the disclosure. "Summary of the invention" also cannot be considered to characterize the invention set forth in the issued claims.

[0279] The embodiments described herein are not intended to be exhaustive of the invention or to limit the invention to the precise forms disclosed in the following detailed description. On the contrary, the embodiments are selected and described so that other persons skilled in the art can understand and appreciate the principles and practices. Therefore, various aspects have been described with reference to various specific and preferred embodiments and techniques. However, it should be understood that many changes and modifications may be made while remaining within the spirit and scope of this article.

Claims

1. A medical visualization system, comprising: Video processing circuit; a central processing circuit, wherein the central processing circuit is in communication with the video processing circuit; as well as A user interface, wherein the user interface is generated by the video processing circuit, and the user interface comprises: a three-dimensional model comprising at least a portion of an anatomical structure of a subject; a graphical representation including at least one cancer therapy stimulation lead; and A visible thermal heating zone, wherein the visible thermal heating zone is associated with the graphical representation of the at least one cancer therapy stimulation lead.

2. The medical visualization system of any one of claims 1 and 3 to 10, wherein the visible thermal heating zone provides a graphical representation of the temperature surrounding tissue adjacent to the at least one cancer therapy stimulation lead.

3. The medical visualization system according to any one of claims 1 to 2 and 4 to 10, the three-dimensional model further comprising a cancerous tumor, a resection cavity or a contrast-enhanced area.

4. The medical visualization system of any one of claims 1 to 3 and 5 to 10, wherein the user interface displays placement of one or more electrodes based on the location of the cancerous tumor, resection cavity, or contrast-enhancing region.

5. The medical visualization system according to any one of claims 1 to 4 and 6 to 10, wherein the three-dimensional model is configured to represent the placement of the at least one cancer therapy stimulation lead; and Wherein the at least one cancer treatment stimulation lead is positioned to avoid one or more critical structures.

6. The medical visualization system of any one of claims 1 to 5 and 7 to 10, wherein the user interface informs the user to place one or more additional cancer therapy stimulation leads to increase field strength.

7. The medical visualization system according to any one of claims 1 to 6 and 8 to 10, wherein the user interface notifies the user when the at least one cancer therapy stimulation lead is proximate to a critical structure; and The critical structures include at least one selected from the group consisting of bones, pituitary gland, blood vessels, hypothalamus, ventricles, brain stem, amygdala, thalamus, cerebellum and corpus callosum.

8. The medical visualization system of any one of claims 1 to 7 and 9 to 10, the user interface further comprising at least one visual burr hole representation, wherein the at least one visual burr hole representation provides a graphical representation of optimal burr hole placement.

9. The medical visualization system of any one of claims 1 to 8 and 10, the user interface further comprising a visual lead trajectory, wherein the visual lead trajectory provides a graphical representation of an optimal trajectory of the at least one cancer therapy stimulation lead.

10. The medical visualization system of any one of claims 1 to 9, wherein aspects of the visible thermal heating zone are calculated based on a therapy vector pattern between electrodes, power of the electrodes, and duty cycle of the electrodes.

11. A medical visualization system, comprising: Video processing circuit; a central processing circuit, wherein the central processing circuit is in communication with the video processing circuit; as well as A user interface, wherein the user interface is generated by the video processing circuit, and the user interface comprises: a three-dimensional model comprising at least a portion of an anatomical structure of a subject; a graphical representation including at least one cancer treatment stimulation lead; a visible thermal heating zone, wherein the visible thermal heating zone is associated with a graphical representation of at least one cancer therapy stimulation lead; and A notification system, wherein the notification system is configured to provide one or more notifications to the user.

12. The medical visualization system of any one of claims 11 and 13 to 14, wherein the notification system notifies the user when the at least one cancer therapy stimulation lead is proximate to one or more critical structures.

13. The medical visualization system of any one of claims 11 to 12 and 14, wherein the medical visualization system notifies the user when the calculated temperature of a critical structure or other designated area exceeds a programmable maximum temperature value.

14. The medical visualization system according to any one of claims 11 to 13, wherein the notification system notifies the user to place one or more additional electrodes to increase field strength.

15. A medical visualization system, comprising: Video processing circuit; a central processing circuit, wherein the central processing circuit is in communication with the video processing circuit; as well as A user interface, wherein the user interface is generated by the video processing circuit, and the user interface comprises: a three-dimensional model comprising at least a portion of an anatomical structure of a subject; a graphical representation including at least one cancer therapy stimulation lead; and A visible electric field strength region, wherein the visible electric field strength region is associated with the graphical representation of the at least one cancer therapy stimulation lead.

Images