Pulse applicator

• US 10,252,050 B2
• Filed: 05/15/2017
• Issued: 04/09/2019
• Est. Priority Date: 05/16/2016
• Status: Active Grant

• Current Assignee: Pulse Biosciences, Inc
• Original Assignee: Pulse Biosciences, Inc
• Inventors: Kreis, Mark P., Danitz, David J., Hinman, Cameron D.
• Primary Examiner(s): Fairchild, Mallika D
• Application Number:
  US15/595,684
• Publication Number:
  US 20170326361A1
• Time in Patent Office: 694 Days
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61N 1/0408 Use-related aspects
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/18 Applying electric currents by contact electrodes
• CPC Class Codes: A61N 1/20 continuous direct currents
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/32 alternating or intermittent currents applying electric fields by inductive or capacitive coupling A61N1/40; microwave apparatus A61N5/02
• CPC Class Codes: A61N 1/36002 Cancer treatment, e.g. tumour

Abstract

The pulse applicator includes a first arm, including a first electrode, a second arm, including a second electrode, and a spacer. The first arm, the spacer, and the second arm are movably connected, and define a gap between the first arm and the second arm. The first electrode, the gap, and the second electrode are selectively alignable, and the first electrode and the second electrode are configured to deliver an electrical field across the gap in response to an electrical pulse received across the first and second electrodes.

Claims

1. A pulse applicator, comprising:

a first arm, comprising a first electrode;

a second arm, comprising a second electrode; and

a spacer comprising a cavity, the spacer positioned such that the first arm and the second arm are on opposing sides of the spacer,

wherein the first arm, the spacer, and the second arm are movably connected to selectively position one or both of the first electrode and the second electrode in alignment with and adjacent to the cavity of the spacer, and wherein the first electrode and the second electrode are configured to deliver an electrical field across the cavity.

2. The pulse applicator of claim 1, wherein each of the first and second arms is independently movable with respect to the spacer.

3. The pulse applicator of claim 1, wherein the cavity is configured to receive and to form at least a partial boundary around a treatment site.

4. The pulse applicator of claim 3, wherein the cavity forms a closed boundary around the treatment site.

5. The pulse applicator of claim 3, wherein the treatment site includes a tumor.

6. The pulse applicator of claim 1, wherein the first arm, the spacer, and the second arm are configured to be movable such that, while at least one of the first arm or the second arm is spaced apart from the spacer, the cavity is exposed so as to be viewable.

7. The pulse applicator of claim 1, further comprising:

a first actuator configured to move the first arm with respect to the spacer; and

a second actuator configured to move the second arm with respect to the spacer.

8. The pulse applicator of claim 7, wherein at least one of the first actuator or the second actuator has an over center design.

9. The pulse applicator of claim 7, wherein at least one of the first actuator or the second actuator causes a linear and a rotational movement of the first arm or the second arm, respectively.

10. The pulse applicator of claim 7, wherein the first arm, the spacer, and the second arm are assembleable and disassembleable by hand, without any tools.

11. The pulse applicator of claim 1, wherein while the first electrode of the first arm is adjacent to the cavity and the second electrode of the second arm is adjacent to the cavity, the first and second electrodes are spaced apart by a predetermined distance so that the electric field has a magnitude equal to a voltage of a pulse applied across the first and second electrodes divided by the predetermined distance.

12. The pulse applicator of claim 1, wherein the first and second electrodes are configured to deliver the electrical field using electric pulses of sub-microsecond pulse duration.

13. The pulse applicator of claim 1, wherein at least one of the first arm, the second arm, or the spacer is configured to pivot about a pivot point.

14. The pulse applicator of claim 1, wherein the spacer is configured to hold a treatment site within the cavity during treatment without applying a force on the treatment site with the first and the second electrodes.

15. A pulse applicator, comprising:

a first arm, comprising a first electrode;

a second arm, comprising a second electrode; and

a spacer positioned such that the first arm and the second arm are on opposing sides of the spacer,

wherein the first arm, the spacer, and the second arm are rotatably connected, such that the first arm and the spacer are configured to face each other and to hold a tumor of a subject adjacent the first electrode and the second arm is configured to be movable so as to selectively position the second electrode adjacent the tumor, and wherein the first electrode and the second electrode are configured to deliver an electrical field across the tumor in response to an electrical pulse received across the first and second electrodes.

16. The pulse applicator of claim 15, wherein the spacer comprises a cavity configured to at least partially bound the tumor.

17. The pulse applicator of claim 15, wherein while the second electrode is adjacent the tumor, the tumor is occluded by the second arm.

18. The pulse applicator of claim 16, wherein the spacer is configured to keep the first electrode at a predefined distance apart from the second electrode when both electrodes are positioned adjacent and aligned with the cavity.

19. The pulse applicator of claim 15, wherein the first and second electrodes are configured to deliver the electrical field using electric pulses of sub-microsecond pulse duration.

20. The pulse applicator of claim 15, further comprising at least one actuator configured to move at least one of the first electrode or the second electrode linearly and rotationally.

21. A method of using a pulse applicator, the pulse applicator comprising a first arm having a first electrode, a second arm having a second electrode, and a spacer positioned such that the first arm and the second arm are on opposing sides of the spacer, wherein the first arm, the spacer, and the second arm are movably connected, the method comprising:

rotating the first arm with respect to the spacer to hold a tumor of a subject adjacent the first electrode;

rotating the second arm with respect to the spacer to align the tumor between the first and second electrodes; and

delivering an electrical field across the tumor in response to an electrical pulse received across the first and second electrodes.

22. The method of claim 21, wherein rotating the first arm with respect to the spacer causes tissue connecting the tumor to the subject to be compressed between the first arm and the spacer.

23. The method of claim 21, wherein the spacer is configured to keep the first electrode at a predefined distance apart from the second electrode when both electrodes are positioned adjacent and aligned with the tumor.

24. The method of claim 21, wherein the first and second electrodes are configured to deliver the electrical field having a nanosecond pulse duration.

25. The method of claim 21, wherein the spacer comprises a cavity configured to hold the tumor.

26. The method of claim 25, further comprising pressing a tissue connected to the tumor against the spacer while at least one of the first or the second arm is spaced apart from the cavity.

27. The method of claim 21, the method comprising, prior to rotating the first arm with respect to the spacer, positioning the spacer relative to the tumor to assist in positioning the first electrode adjacent the tumor.

28. The method of claim 21, the method comprising causing a linear and a rotational movement of at least one of the first or the second arm relative to the spacer.

29. The method of claim 21, the method comprising applying a force to a first actuator to rotate the first arm.

30. A method of using a pulse applicator, the pulse applicator comprising a first arm having a first electrode, a second arm having a second electrode, and a spacer comprising a cavity and positioned such that the first arm and the second arm are on opposing sides of the spacer, the method comprising:

positioning the first and the second arms relative to the spacer such that the cavity of the spacer is viewable;

placing a treatment site such that it is aligned with and at least partially bound by the cavity;

moving the second arm to substantially align the second electrode with the cavity such that the second electrode is adjacent the treatment site; and

moving the first arm to substantially align the first electrode with the cavity.

31. The method of claim 30, wherein positioning the first and the second arms relative to the spacer comprises rotatably moving the first arm relative to the spacer such that the first electrode is spaced apart from the cavity.

32. The method of claim 30, wherein moving the first arm and/or the second arm comprises pivoting the first arm and/or the second arm about a pivot point.

33. The method of claim 30, wherein placing the treatment site to be aligned with the cavity causes the treatment site to be observable by a user.

34. The method of claim 30, wherein the second arm is a bottom arm and moving the second arm to substantially align the second electrode with the cavity causes tissue connecting the treatment site to a subject to be between the second arm and the spacer.

35. The method of claim 30, further comprising delivering an electrical field across the treatment site in response to an electrical pulse received across the first and second electrodes.

36. The method of claim 35, wherein while the first electrode of the first arm is adjacent to the cavity and the second electrode of the second arm is adjacent to the cavity, the first and second electrodes are spaced apart by a predetermined distance so that the electric field has a magnitude equal to a voltage of the electrical pulse applied across the first and second electrodes divided by the predetermined distance.

37. The method of claim 35, wherein the electric field delivered across the treatment site has a sub-microsecond pulse duration.

38. The method of claim 30, wherein the treatment site is not connected to a subject.

39. The method of claim 30, the method comprising moving the first electrode with respect to the cavity by applying a force to a first actuator and moving the second electrode with respect to the cavity by applying a force to a second actuator.

40. The method of claim 30, wherein moving the second arm to substantially align the second electrode with the cavity comprises causing a linear and/or a rotational movement of the second electrode.

41. The method of claim 30, further comprising disassembling the pulse applicator by hand without any tools.