Treatment planning for electroporation-based therapies

• US 9,198,733 B2
• Filed: 10/18/2010
• Issued: 12/01/2015
• Est. Priority Date: 04/29/2008
• Status: Active Grant

• Current Assignee: Virginia Tech Intellectual Properties, Inc.
• Original Assignee: Virginia Tech Intellectual Properties, Inc.
• Inventors: Neal, Robert E. II, Davalos, Rafael V., Rossmeisl, John H., Robertson, John L., Garcia, Paulo A.
• Primary Examiner(s): Stoklosa, Joseph
• Assistant Examiner(s): Ram, Jocelyn D
• Application Number:
  US12/906,923
• Publication Number:
  US 20110106221A1
• Time in Patent Office: 1,870 Days
• Field of Search: 606/34, 606/41, 435/173.6
• US Class Current: 1/1
• CPC Class Codes: A61B 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 2018/00613 Irreversible electroporation reversible electroporation A61N1/327
• CPC Class Codes: A61B 2034/104 Modelling the effect of the tool, e.g. the effect of an implanted prosthesis or for predicting the effect of ablation or burring
• CPC Class Codes: A61B 2034/105 Modelling of the patient, e.g. for ligaments or bones
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations
• CPC Class Codes: A61N 1/0412 Specially adapted for transcutaneous electroporation, e.g. including drug reservoirs
• CPC Class Codes: C12N 13/00 Treatment of microorganisms or enzymes with electrical or wave energy, e.g. magnetism, sonic waves
• CPC Class Codes: G16H 50/50 for simulation or modelling of medical disorders

Abstract

The present invention provides systems, methods, and devices for electroporation-based therapies (EBTs). Embodiments provide patient-specific treatment protocols derived by the numerical modeling of 3D reconstructions of target tissue from images taken of the tissue, and optionally accounting for one or more of physical constraints or dynamic tissue properties. The present invention further relates to systems, methods, and devices for delivering bipolar electric pulses for irreversible electroporation exhibiting reduced or no damage to tissue typically associated with an EBT-induced excessive charge delivered to the tissue.

Claims

1. A treatment planning system for determining a patient-specific electroporation-based treatment protocol comprising:

a processing module operably configured for performing the following stages;

receiving and processing information from medical images of a target structure and preparing a 3-D reconstruction model of the target structure;

performing a numerical model analysis using as inputs in the analysis the 3-D reconstruction and electrical conductivity; and

constructing one or more protocols each providing a treatment region with parameters for electroporating the target structure; and

a processor for executing the stages of the processing module.

2. The treatment planning system of claim 1, wherein the processing module is capable of performing the stages in real time.

3. The treatment planning system of claim 2, wherein the processing module further comprises functionality for monitoring electrode or tissue temperature in real time and for considering electrode or tissue temperature in the analysis.

4. The treatment planning system of claim 1, wherein the information from medical images is extracted from an array of images obtained from one or more imaging modalities chosen from radiographs, tomography, nuclear scintigraphy, CT, MRI, fMRI, PET, or US.

5. The treatment planning system of claim 1, wherein the numerical model analysis comprises finite element modeling (FEM).

6. The treatment planning system of claim 5, wherein the target structure is a targeted region or mass;

or is a targeted region or mass with neighboring regions;

or is a 3D map of voxels to be treated as independent elements in the finite modeling software.

7. The treatment planning system of claim 1, wherein the 3D reconstruction is a surface or a solid volume.

8. The treatment planning system of claim 1, wherein the numerical model analysis involves accounting for physical constraints, tissue heterogeneities, dynamic effects of electropermeabilization, dynamic thermal effects, and multiple-treatment effects.

9. The treatment planning system of claim 1, further comprising a self-optimization algorithm for constructing the protocols.

10. The treatment planning system of claim 9, wherein the self-optimization algorithm is capable of repeatedly evaluating one or more of physical constraints, placement of electrodes, electric field distribution simulations, and outcome success of the protocols, and evaluation of outcome success until one or more effective protocol is constructed.

11. The treatment planning system of claim 1, wherein the treatment region and parameters for electroporating are determined automatically, interactively, or automatically and interactively with or without user input.

12. The treatment planning system of claim 1, capable of constructing protocols for an initial patient treatment or retreatment with or without additional medical images.

13. The treatment planning system of claim 1, further adapted for instructing an electrical waveform generator to perform the protocol.

14. The treatment planning system of claim 13, further comprising an electrical waveform generator in operable communication with the processing module and capable of receiving and executing the treatment protocol.

15. The treatment planning system of claim 14, wherein the generator is operably configured for delivering a bipolar pulse train.

16. The treatment planning system of claim 13, wherein instructing comprises specifying a number of bipolar pulses to be delivered, a length of pulse duration at any pole, and a length of any delay between pulses.

17. The treatment planning system of claim 1, wherein the electrical conductivity is provided as a conductivity map.

18. A treatment planning method comprising:

receiving and processing information from medical images of a target structure and preparing a 3-D reconstruction model of the target structure;

performing a numerical model analysis using as inputs in the analysis the 3-D reconstruction and electrical conductivity;

and constructing an electroporation protocol based on results of the analyzing;

wherein the receiving, processing, analyzing, and constructing is performed in real time.

19. The treatment planning system of claim 18, wherein the electrical conductivity is provided as a conductivity map.

20. The method of claim 18, wherein the information from medical images is extracted from images obtained from one or more imaging modalities chosen from radiographs, tomography, nuclear scintigraphy, CT, MRI, fMRI, PET, or US.

21. The method of claim 18, wherein the numerical model analysis comprises finite element modeling (FEM).

22. The method of claim 21, wherein the target structure is a targeted region or mass;

or is a targeted region or mass with neighboring regions;

or is a 3D map of voxels to be treated as independent elements in the finite modeling software.

23. The method of claim 18, wherein the 3D reconstruction is a surface or a solid volume.

24. The method of claim 18, wherein the numerical model analysis involves accounting for physical constraints, tissue heterogeneities, dynamic effects of electropermeabilization, dynamic thermal effects, or multiple-treatment effects.

25. The method of claim 18, wherein the electroporation protocol is determined automatically, interactively, or automatically and interactively with or without user input.

26. The method of claim 18, capable of constructing protocols for an initial patient treatment or retreatment with or without additional medical images.

27. The method of claim 18, further comprising instructing an electrical waveform generator to perform the electroporation protocol.

28. The method of claim 27, wherein the instructing comprises specifying a number of bipolar pulses to be delivered, a length of pulse duration at any pole, and a length of any delay between pulses.

29. The method of claim 27, wherein the instructing comprises instructions for delivering a bipolar pulse train.

30. The method of claim 18, further comprising monitoring electrode or tissue temperature in real time and considering electrode or tissue temperature in the analyzing.