IP Library Granted Patent US 9,750,946
Granted Patent B2
US 9,750,946 · App. 15/174,318 · Granted Sep 5, 2017

Systems, methods, and devices for evaluating lead placement based on generated visual representations of sacrum and lead

Inventors: Norbert Kaula (Arvada, CO); Yohannes Iyassu (Denver, CO); Steven Siegel (North Oaks, MN)
Assignee: NUVECTRA CORPORATION
A61N1/37247A61N1/36057A61N1/36071A61N1/0551A61N1/36007A61N1/36107A61N1/36132A61N1/36135A61N1/36142
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Quick Facts
Patent No.
US 9,750,946
App. No.
15/174,318
Granted
Sep 5, 2017
Kind
B2
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 (50)

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.

2. 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.

3. 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.

4. 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.

5. 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.

6. The portable electronic programmer of claim 1 , wherein the visual representation of the sacrum and the lead contains three-dimensional (3D) models.

7. 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.

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.

9. 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.

10. 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.

11. 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.

12. 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.

13. The medical system of claim 8 , wherein the visual representation of the sacrum and the lead contains three-dimensional (3D) models.

14. 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.

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.

16. 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.

17. The method of claim 16 , wherein the communicating comprises providing, via the graphical user interface, instructions on guiding the user to reposition the lead.

18. 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.

19. 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.

20. The method of claim 15 , wherein the visual representation of the sacrum and the lead contains three-dimensional (3D) models.

Assignments (4)
PATENT SECURITY AGREEMENT Recorded Jan 30, 2023
From: CIRTEC MEDICAL CORP.
To: BMO HARRIS BANK N.A., AS COLLATERAL AGENT
Reel/Frame 062559/0098 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 18, 2020
From: NUVECTRA CORPORATION
To: CIRTEC MEDICAL CORP.
Reel/Frame 052185/0680 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 19, 2017
From: SIEGEL, STEVEN WILLIAM, MD
To: NUVECTRA CORPORATION
Reel/Frame 042748/0356 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2016
From: KAULA, NORBERT; IYASSU, YOHANNES
To: NUVECTRA CORPORATION
Reel/Frame 038819/0641 →
Continuity (3)
Provisional Application 62173118 · Jun 9, 2015
Provisional Application 62181827 · Jun 19, 2015
Related Publication 20160361554A1 · Dec 15, 2016