# US 9,750,946 B2 · Systems, methods, and devices for evaluating lead placement based on generated visual representations of sacrum and lead > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,750,946 B2 - Document ID: US9750946B2 - Status: Granted - Kind: B2 - Application number: 15/174,318 - Filed: 2016-06-06 - Published: 2016-12-15 - Granted: 2017-09-05 - Earliest claimed: 2015-06-09 - Assignees: Nuvectra Corporation - Applicants: Nuvectra Corporation - Inventors: Norbert Kaula; Yohannes Iyassu; Steven Siegel - Web page: https://patentgrep.com/patent/US9750946B2 ## CPC - A61N 1/37247: {User interfaces, e.g. input or presentation means} - A61N 1/36057: {adapted for stimulating afferent nerves} - A61N 1/36071: {Pain} - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61N 1/36107: {Sexual dysfunction (stimulating genital organs A61N1/36007)} - A61N 1/36132: {using patient feedback} - A61N 1/36135: {using physiological parameters} - A61N 1/36142: {for improving safety} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract A method of evaluating an implantation of a lead is disclosed. Via a graphical user interface of an electronic device, a visual representation of a sacrum of the patient and a lead that is implanted in the sacrum is displayed. The lead includes a plurality of electrode contacts. An evaluation is made as to how well the lead has been implanted in the sacrum based on the visual representation of the sacrum and the lead. The evaluating comprises: determining whether the lead is inserted in a predetermined region of the sacrum, determining how far a predetermined one of the electrode contacts is located from an edge of the sacrum, and determining a degree of curvature of the lead. ## Claims ### Claim 1 A portable electronic programmer, comprising: a graphical user interface configured to receive an input from a user and display an output to the user; an electronic memory storage configured to store programming instructions; and one or more processors configured to execute the programming instructions to perform the following steps: displaying, via the graphical user interface, a visual representation of a sacrum of the patient and a lead that is implanted in the sacrum, the lead including a plurality of electrode contacts; and evaluating how well the lead has been implanted in the sacrum based on the visual representation of the sacrum and the lead, wherein the evaluating comprises: determining whether the lead is inserted in a predetermined region of the sacrum; determining how far a predetermined one of the electrode contacts is located from an edge of the sacrum; and determining a degree of curvature of the lead. ### Claim 2 (depends on 1) The portable electronic programmer of claim 1, wherein the steps further comprise: communicating, to a user via the graphical user interface, an evaluation of how well the lead has been implanted. ### Claim 3 (depends on 2) The portable electronic programmer of claim 2, wherein the communicating comprises providing, via the graphical user interface, instructions on guiding the user to reposition the lead. ### Claim 4 (depends on 1) The portable electronic programmer of claim 1, wherein the steps further comprise: displaying, via the graphical user interface, a visual representation of an expected lead that is superimposed on the visual representation of the sacrum, wherein the visual representation of the expected lead represents an implant location of the lead that is expected to result in optimal electrical stimulation therapy. ### Claim 5 (depends on 1) The portable electronic programmer of claim 1, wherein: the determining of whether the lead is inserted into a predetermined region of the sacrum comprises determining whether the lead is inserted into an S3 foramen and along a vertebral fusion plane; the determining of how far the predetermined one of the electrode contacts is located from an edge of the sacrum comprises determining whether an electrode contact at an end of the lead is located within a predetermined distance from the edge of the sacrum; and the determining of the degree of curvature comprises determining whether the degree of curvature is within a predefined threshold. ### Claim 6 (depends on 1) The portable electronic programmer of claim 1, wherein the visual representation of the sacrum and the lead contains three-dimensional (3D) models. ### Claim 7 (depends on 1) The portable electronic programmer of claim 1, wherein the electronic programmer comprises a clinician programmer configured to program a pulse generator to deliver electrical stimulation to the patient through the lead. ### Claim 8 A medical system, comprising: a pulse generator configured to generate electrical stimulation pulses as a part of an electrical stimulation therapy for a patient; an implantable lead configured to deliver the electrical stimulation pulses to the patient; and a portable electronic device that is telecommunicatively coupled to the pulse generator through a communications link, wherein the portable electronic device is configured to perform the following steps: displaying, via a graphical user interface of an electronic device, a visual representation of a sacrum of the patient and a lead that is implanted in the sacrum, the lead including a plurality of electrode contacts; and evaluating how well the lead has been implanted in the sacrum based on the visual representation of the sacrum and the lead, wherein the evaluating comprises: determining whether the lead is inserted in a predetermined region of the sacrum; determining how far a predetermined one of the electrode contacts is located from an edge of the sacrum; and determining a degree of curvature of the lead. ### Claim 9 (depends on 8) The medical system of claim 8, wherein the steps further comprise: communicating, to a user via the graphical user interface, an evaluation of how well the lead has been implanted. ### Claim 10 (depends on 9) The medical system of claim 9, wherein the communicating comprises providing, via the graphical user interface, instructions on guiding the user to reposition the lead. ### Claim 11 (depends on 8) The medical system of claim 8, wherein the steps further comprise: displaying, via the graphical user interface, a visual representation of an expected lead that is superimposed on the visual representation of the sacrum, wherein the visual representation of the expected lead represents an implant location of the lead that is expected to result in optimal electrical stimulation therapy. ### Claim 12 (depends on 8) The medical system of claim 8, wherein: the determining of whether the lead is inserted into a predetermined region of the sacrum comprises determining whether the lead is inserted into an S3 foramen and along a vertebral fusion plane; the determining of how far the predetermined one of the electrode contacts is located from an edge of the sacrum comprises determining whether an electrode contact at an end of the lead is located within a predetermined distance from the edge of the sacrum; and the determining of the degree of curvature comprises determining whether the degree of curvature is within a predefined threshold. ### Claim 13 (depends on 8) The medical system of claim 8, wherein the visual representation of the sacrum and the lead contains three-dimensional (3D) models. ### Claim 14 (depends on 8) The medical system of claim 8, wherein the electronic device comprises a clinician programmer configured to program the pulse generator to deliver electrical stimulation to the patient through the lead. ### Claim 15 A method of evaluating an implantation of a lead configured to deliver electrical stimulation therapy for a patient, comprising: displaying, via a graphical user interface of an electronic device, a visual representation of a sacrum of the patient and a lead that is implanted in the sacrum, the lead including a plurality of electrode contacts; and evaluating, via one or more hardware processors of the electronic device, how well the lead has been implanted in the sacrum based on the visual representation of the sacrum and the lead, wherein the evaluating comprises: determining whether the lead is inserted in a predetermined region of the sacrum; determining how far a predetermined one of the electrode contacts is located from an edge of the sacrum; and determining a degree of curvature of the lead. ### Claim 16 (depends on 15) The method of claim 15, further comprising: communicating, to a user via the graphical user interface, an evaluation of how well the lead has been implanted. ### Claim 17 (depends on 16) The method of claim 16, wherein the communicating comprises providing, via the graphical user interface, instructions on guiding the user to reposition the lead. ### Claim 18 (depends on 15) The method of claim 15, further comprising: displaying, via the graphical user interface, a visual representation of an expected lead that is superimposed on the visual representation of the sacrum, wherein the visual representation of the expected lead represents an implant location of the lead that is expected to result in optimal electrical stimulation therapy. ### Claim 19 (depends on 15) The method of claim 15, wherein: the determining of whether the lead is inserted into a predetermined region of the sacrum comprises determining whether the lead is inserted into an S3 foramen and along a vertebral fusion plane; the determining of how far the predetermined one of the electrode contacts is located from an edge of the sacrum comprises determining whether an electrode contact at an end of the lead is located within a predetermined distance from the edge of the sacrum; and the determining of the degree of curvature comprises determining whether the degree of curvature is within a predefined threshold. ### Claim 20 (depends on 15) The method of claim 15, wherein the visual representation of the sacrum and the lead contains three-dimensional (3D) models.