Percutaneous electrical therapy system with sharp point protection

• US 6,539,264 B1
• Filed: 12/01/1999
• Issued: 03/25/2003
• Est. Priority Date: 12/01/1999
• Status: Expired due to Fees

• Current Assignee: Meagan Medical, Inc.
• Original Assignee: Vertis Neuroscience, Inc. (Northstar Neuroscience, Inc.)
• Inventors: Leyde, Kent W., Bishay, Jon M., Leonard, Paul
• Primary Examiner(s): Layno, Carl
• Application Number:
  US09/451,547
• Time in Patent Office: 1,210 Days
• Field of Search: 607/46, 607/115, 607/116, 607/146, 607/145
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

A percutaneous electrical therapy system includes sharp point protection. In one embodiment, the system includes a control unit; an electrode assembly adapted to deliver electrical therapy to a patient, where the electrode assembly has an electrode electrically connectable to the control unit, the electrode having a sharp point at a distal end adapted to be inserted into the patient'"'"'s tissue; and a sharp point protection assembly operable with the electrode assembly for reducing the risk of unintended exposure to the electrode'"'"'s point. The system can also include an electrode assembly and sharp point protection assembly for a percutaneous electrical therapy system, as described above, apart from the control unit. In another embodiment, a method of performing percutaneous electrical therapy can include providing an electrode assembly having an electrode, the electrode having a sharp point at a distal end; inserting the sharp point of the electrode into a patient'"'"'s tissue without exposing the sharp point to anyone but the patient; and applying an electrical signal to the electrode from a control unit.

Claims

1. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable a the control unit, the electrode comprising a sharp point at a distal end configured to be inserted into the patient'"'"'s tissue; and

a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode'"'"'s point;

wherein the sharp point protection assembly comprises a housing to contain at least the sharp point of the electrode when the electrode is in an undeployed state; and

wherein the sharp point protection assembly further comprises a locking assembly preventing relative movement between the electrode and the housing.

2. The system of claim 1 wherein the sharp point of the electrode is outside of the housing in a deployed state, the housing being configured to contain a portion of the electrode in the deployed state.

3. The system of claim 1 wherein the locking assembly comprises a spring-biased detent.

4. The system of claim 1 further comprising a tool configured to release the locking assembly and to move the sharp point of the electrode out of the housing.

5. The system of claim 4 wherein the tool is further configured to move the sharp point of the electrode back into the housing after having moved the sharp point of the electrode out of the housing and to engage the locking assembly to prevent further relative movement between the electrode and the housing.

6. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable to a control unit, the electrode comprising a sharp point at a distal end configured to be inserted into the patient'"'"'s tissue; and

a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode'"'"'s point;

wherein the sharp point protection assembly comprises a housing to contain at least the sharp point of the electrode when the electrode is in an undeployed state; and

wherein the electrode assembly further comprises an actuator attached to a proximal end of the electrode, the actuator being disposed within and movable within the housing; and

wherein the system further comprises

an actuator tool configured to interact with the actuator to move the sharp point of the electrode out of the housing.

7. The system of claim 6 wherein the actuator tool is further configured to move the sharp point of the electrode back into the housing after having moved the sharp point of the electrode out of the housing.

8. The system of claim 7 wherein the actuator tool has an electrical contact configured to make electrical communication between the electrode and the control unit.

9. The system of claim 6 further comprising a locking assembly preventing relative movement between the actuator and the housing, the actuator tool being configured to release the locking mechanism and to move the sharp point of the electrode out of the housing.

10. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable to a control unit, the electrode comprising a sharp point at a distal end configured to be inserted into the patient'"'"'s tissue; and

a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode'"'"'s point;

wherein the sharp point protection assembly comprises a housing to contain at least the sharp point of the electrode when the electrode is in an undeployed state; and

wherein the housing is configured to contain none of the electrode when the electrode is in a deployed state in which the sharp point of the electrode has been inserted into the patient'"'"'s tissue.

11. The system of claim 10 wherein the housing is configured to contain a plurality of electrodes.

12. The system of claim 10 further comprising an actuator configured to move the electrode out of the housing.

13. The system of claim 12 wherein the housing is configured to contain a plurality of electrodes, the actuator being further configured to move each electrode out of the housing one at a time.

14. The system of claim 10 wherein the electrode assembly further comprises a patch configured to be placed on the patient'"'"'s skin and to support the electrode in the deployed state.

15. The system of claim 14 wherein the patch has an opening configured to surround a portion of the electrode when the electrode is in the deployed state.

16. The system of claim 15 wherein the patch further comprises an annular member disposed in the patch opening and configured to engage a handle portion of the electrode.

17. The system of claim 16 wherein the annular member comprises a raised portion disposed above the patch and configured to engage an aperture of the housing.

18. The system of claim 10 further comprising an electrical connector attachable to the electrode handle portion to make electrical communication between the electrode and the control unit.

19. The system of claim 10 wherein the sharp point protection assembly further comprises an aperture in the housing configured to permit the electrode to pass through for deployment of the electrode.

20. The system of claim 10 wherein the housing is a first housing, the sharp point protection assembly further comprising a second housing to contain at least the sharp point of the electrode when the electrode has moved from the deployed state to an undeployed state.

21. The system of claim 20 further comprising an actuator configured to move the electrode into the second housing.

22. The system of claim 21 further comprising an electrode grasper configured to grasp the electrode in response to movement of the actuator.

23. The system of claim 22 wherein the electrode grasper is a fork configured to mate with a handle portion of the electrode.

24. The system of claim 20 wherein the second housing is configured to contain at least the sharp points of a plurality of electrodes.

25. The system of claim 24 further comprising an actuator configured to move a plurality of electrodes into the second housing.

26. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable to a control unit, the electrode comprising a sharp point at a distal end configured to be inserted into the patient'"'"'s tissue;

a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode'"'"'s point;

a movable actuator configured to move the sharp point of the electrode into the patient'"'"'s tissue; and

an actuator limit element limiting movement of the actuator and controlling depth of insertion of the sharp point of the electrode into the patient'"'"'s tissue.

27. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable to a control unit, the electrode comprising a sharp point at a distal end configured to be inserted into the patient'"'"'s tissue; and

a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode'"'"'s point;

wherein the electrode assembly further comprises an electrode insertion depth control mechanism.

28. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable to a control unit, the electrode comprising a sharp point at a distal end configured to be inserted into the patient'"'"'s tissue;

a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode'"'"'s point; and

an electrode insertion axial stabilizer configured to provide axial stability to the electrode during insertion of the sharp point of the electrode into the patient'"'"'s tissue.

29. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable to a control unit, the electrode comprising a sharp point at a distal end configured to be inserted into the patient'"'"'s tissue;

a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode'"'"'s point; and

an electrode insertion pain reducer configured to reduce pain experienced by the patient during insertion of the sharp point of the electrode into the patient'"'"'s tissue.

30. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a patient, the electrode assembly comprising an electrode electrically connectable to a control unit, the electrode comprising a sharp point at a distal end configured to be inserted into the patient'"'"'s tissue;

a sharp point protection assembly operable with the electrode assembly for reducing risk of unintended exposure to the electrode'"'"'s point; and

an electrode angle of entry controller configured to control the electrode'"'"'s entry angle during insertion of the sharp point of the electrode into the patient'"'"'s tissue.

31. A method of performing percutaneous electrical therapy comprising:

providing an electrode assembly comprising an electrode, the electrode comprising a sharp point at a distal end;

inserting the sharp point of the electrode into a patient'"'"'s tissue without exposing the sharp point to anyone but the patient; and

applying an electrical signal to the electrode from a control unit;

wherein inserting the sharp point of the electrode into a patient'"'"'s tissue comprises using the electrode assembly to guide electrode entry angle.

32. The method of claim 31 further comprising:

removing the electrode from the patient'"'"'s tissue without exposing the sharp point to anyone but the patient.

33. The method of claim 31 further comprising:

making an electrical connection between the electrode and the control unit.

34. The method of claim 31 further comprising after the inserting step:

supporting the electrode in the patient'"'"'s tissue.

35. A method of performing percutaneous electrical therapy comprising:

providing an electrode assembly comprising an electrode, the electrode comprising a sharp point at a distal end;

inserting the sharp point of the electrode into a patient'"'"'s tissue without exposing the sharp point to anyone but the patient; and

applying an electrical signal to the electrode from a control unit;

wherein inserting the sharp point of the electrode into a patient'"'"'s tissue comprises using an introducer to guide electrode entry angle.

36. The method of claim 35 wherein the inserting step comprises:

providing axial stability to the electrode during insertion.

37. The method of claim 35 wherein the inserting step comprises:

placing a housing adjacent the patient'"'"'s tissue; and

moving the sharp point of the electrode out of the housing and into the patient'"'"'s tissue.

38. A method of performing percutaneous electrical therapy comprising:

providing an electrode assembly comprising an electrode, the electrode comprising a sharp point at a distal end;

inserting the sharp point of the electrode into a patient'"'"'s tissue without exposing the sharp point to anyone but the patient; and

applying an electrical signal to the electrode from a control unit;

wherein inserting the sharp point of the electrode into a patient'"'"'s tissue comprises;

placing a housing adjacent the patient'"'"'s tissue; and

moving the sharp point of the electrode out of the housing and into the patient'"'"'s tissue; and

wherein the method further comprises

placing a patch on the patient'"'"'s tissue prior to placing a housing adjacent the patient'"'"'s tissue, wherein placing a housing adjacent the patient'"'"'s tissue comprises placing the housing adjacent the patch.

39. The method of claim 38 wherein the patch comprises an opening, and moving the sharp point of the electrode comprises moving the sharp point of the electrode out of the housing, through the opening and into the patient'"'"'s tissue.

40. The method of claim 38 further comprising:

mechanically supporting at least a portion of the electrode with the patch.

41. A method of performing percutaneous electrical therapy comprising:

providing an electrode assembly comprising an electrode, the electrode comprising a sharp point at a distal end;

inserting the sharp point of the electrode into a patient'"'"'s tissue without exposing the sharp point to anyone but the patient; and

applying an electrical signal to the electrode from a control unit;

wherein inserting the sharp point of the electrode into a patient'"'"'s tissue comprises;

placing a housing adjacent the patient'"'"'s tissue; and

moving the sharp point of the electrode out of the housing and into the patient'"'"'s tissue;

wherein moving the sharp point of the electrode comprises;

moving the entire electrode out of the housing; and

removing the housing from the patient'"'"'s tissue;

wherein the housing comprises a first housing, the method further comprising;

removing the electrode from the patient'"'"'s tissue into a second housing without exposing the sharp point to anyone but the patient.