Percutaneous electrical therapy system with electrode depth control

• US 6,549,810 B1
• Filed: 12/01/1999
• Issued: 04/15/2003
• 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: Bishay, Jon M., Leonard, Paul
• Primary Examiner(s): LAYNO, CARL HERNANDZ
• Application Number:
  US09/452,508
• Time in Patent Office: 1,231 Days
• Field of Search: 600/372, 600/382, 600/386, 600/584, 128/907, 128/DIG.26, 607/46, 607/115, 607/145, 607/148, 607/149
• US Class Current: 607/115
• 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 with electrode angle of entry control. In one embodiment, the system includes a control unit; an electrode assembly adapted to deliver electrical therapy to a patient, the electrode assembly including an electrode electrically connectable to the control unit, the electrode having a sharp point at a distal end adapted to be inserted into a patient'"'"'s tissue; and an electrode depth control assembly adapted to control insertion of the electrode'"'"'s point to a predetermined depth into the patient'"'"'s tissue. The electrode depth control assembly can have a limit stop limiting length of travel of the electrode'"'"'s point. The system can also include the percutaneous electrode and depth control assembly described above apart from the control unit. In another embodiment, a method of performing percutaneous electrical therapy includes providing an electrode assembly comprising an electrode, the electrode having a sharp point at a distal end; using an electrode depth control assembly to insert the sharp point of the electrode a predetermined depth into a patient'"'"'s tissue; 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 recipient, 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 recipient'"'"'s tissue;

an electrode depth control assembly configured to control insertion of the electrode'"'"'s point to a predetermined depth into the recipient'"'"'s tissue, the electrode depth control assembly including an electrode actuator and a limit stop that limits a length of travel of the electrode'"'"'s point and limits movement of the electrode actuator; and

an actuator tool configured to interact with the actuator to move the electrode'"'"'s sharp point into the recipient'"'"'s tissue, wherein the actuator tool has an electrical contact configured to make electrical communication between the electrode and the control unit.

2. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a recipient, 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 recipient'"'"'s tissue;

an electrode depth control assembly configured to control insertion of the electrode'"'"'s point to a predetermined depth into the recipient'"'"'s tissue;

an electrode introducer configured to insert the electrode into the recipient and release the electrode, the electrode introducer comprising the depth control assembly; and

a transmission assembly configured to insert the electrode'"'"'s point the predetermined depth into the recipient'"'"'s tissue when the actuator is moved a predetermined actuator distance, the predetermined depth being greater than the predetermined actuator distance;

wherein the electrode depth control assembly comprises a limit stop limiting length of travel of the electrode'"'"'s point; and

wherein the electrode introducer comprises an actuator cooperating with the limit stop, the actuator being configured to move the sharp point of the electrode into the recipient'"'"'s tissue.

3. The system of claim 2 wherein the transmission assembly transmits linear movement of the actuator into linear movement of the electrode.

4. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a recipient, 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 recipient'"'"'s tissue; and

an electrode depth control assembly configured to control insertion of the electrode'"'"'s point to a predetermined depth into the recipient'"'"'s tissue;

wherein the electrode depth control assembly comprises an electrode holder configured to be mounted on the recipient and to interact mechanically with the electrode; and

wherein the electrode holder comprises an adhesive patch.

5. A percutaneous electrical therapy system, comprising:

an electrode assembly configured to deliver electrical therapy to a recipient, 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 recipient'"'"'s tissue; and

an electrode depth control assembly configured to control insertion of the electrode'"'"'s point to a predetermined depth into the recipient'"'"'s tissue;

wherein the electrode depth control assembly comprises an electrode holder configured to be mounted on the recipient and to interact mechanically with the electrode, and further comprises a handle portion on a proximal end of the electrode.

6. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a recipient, 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 recipient'"'"'s tissue;

an electrode depth control assembly configured to control insertion of the electrode'"'"'s point to a predetermined depth into the recipient'"'"'s tissue; 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 recipient'"'"'s tissue.

7. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a recipient, 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 recipient'"'"'s tissue;

an electrode depth control assembly configured to control insertion of the electrode'"'"'s point to a predetermined depth into the recipient'"'"'s tissue; and

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

8. A percutaneous electrical therapy system comprising:

an electrode assembly configured to deliver electrical therapy to a recipient, 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 recipient'"'"'s tissue;

an electrode depth control assembly configured to control insertion of the electrode'"'"'s point to a predetermined depth into the recipient'"'"'s tissue; 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 recipient'"'"'s tissue.

9. 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;

using an electrode depth control assembly to insert the sharp point of the electrode a predetermined depth into a recipient'"'"'s tissue; and

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

wherein using an electrode depth control assembly comprises moving an actuator a predetermined actuator distance, the actuator moving the electrode to insert the sharp point of the electrode into the recipient'"'"'s tissue, wherein the predetermined actuator distance is less than the predetermined depth.

10. 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;

using an electrode depth control assembly to insert the sharp point of the electrode a predetermined depth into a recipient'"'"'s tissue by mounting an electrode holder on the recipient and mechanically interacting the electrode with the electrode holder; and

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

wherein using an electrode depth control assembly comprises moving an actuator a predetermined actuator distance, the actuator moving the electrode to insert the sharp point of the electrode into the recipient'"'"'s tissue.

11. The method of claim 10 wherein mechanically interacting the electrode with the electrode holder comprises inserting the electrode through an opening in the electrode holder.

12. 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;

using an electrode depth control assembly to insert the sharp point of the electrode a predetermined depth into a recipient'"'"'s tissue; and

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

wherein using an electrode depth control assembly comprises using an actuator tool to move an actuator, the actuator moving the electrode to insert the sharp point of the electrode into the recipient'"'"'s tissue.

13. The method of claim 12 further comprising using the actuator tool to remove the sharp point of the electrode from the recipient.

14. 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;

using an electrode depth control assembly to insert the sharp point of the electrode a predetermined depth into a recipient'"'"'s tissue; and

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

wherein using an electrode depth control assembly to insert the sharp point of the electrode comprises using the electrode assembly to guide an electrode entry angle.

15. 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;

using an electrode depth control assembly to insert the sharp point of the electrode a predetermined depth into a recipient'"'"'s tissue; and

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

wherein using an electrode depth control assembly to insert the sharp point of the electrode comprises using an introducer to guide an electrode entry angle.

16. 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;

using an electrode depth control assembly to insert the sharp point of the electrode a predetermined depth into a recipient'"'"'s tissue; and

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

wherein using an electrode depth control assembly to insert the sharp point of the electrode comprises;

providing axial stability to the electrode during insertion.

17. 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;

using an electrode depth control assembly to insert the sharp point of the electrode a predetermined depth into a recipient'"'"'s tissue; and

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

wherein using an electrode depth control assembly to insert the sharp point of the electrode comprises;

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

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

wherein the method further comprises

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

18. The method of claim 17 wherein the patch comprises an opening, and wherein 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 recipient'"'"'s tissue.

19. The method of claim 17 further comprising:

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

20. A percutaneous electrical therapy system, comprising:

a housing configured to removably receive an actuator tool;

an electrode electrically connectable to a control unit, the electrode having a sharp point configured to be inserted into a recipient'"'"'s tissue, the electrode being movable relative to the housing between a stowed position and a deployed position, the electrode being positioned to make electrical contact with the actuator tool when the actuator tool is received by the housing; and

an electrode depth control assembly configured to control insertion of the sharp point of the electrode to a predetermined depth in the recipient'"'"'s tissue.

21. The system of claim 20, further comprising an actuator received in the housing, wherein the actuator supports the electrode and wherein the actuator is releasably engageable with the actuator tool when the actuator tool is received in the housing.

22. The system of claim 20, further comprising the actuator tool.

23. The system of claim 20, further comprising an adhesive patch attached to the housing and positioned to releasably adhere to the recipient'"'"'s skin.

24. A percutaneous electrical therapy system, comprising:

a housing configured to be removably positioned against the skin of a recipient;

an electrode electrically connectable to a control unit, the electrode having a sharp point configured to be inserted through the recipient'"'"'s skin and into the recipient'"'"'s tissue, the electrode being movable relative to the housing between a stowed position and a deployed position; and

an electrode depth control assembly configured to control insertion of the sharp point of the electrode to a predetermined depth in the recipient'"'"'s tissue.

25. The system of claim 24, further comprising an actuator received in the housing, wherein the actuator supports the electrode and wherein the actuator is releasably engageable with an actuator tool when the actuator tool is received in the housing.

26. The system of claim 24, further comprising:

an actuator received in the housing, wherein the actuator supports the electrode; and

an actuator tool releasably engageable with the actuator to move the actuator and the electrode relative to the housing.

27. The system of claim 24, further comprising an adhesive patch attached to the housing and positioned to releasably adhere to the recipient'"'"'s skin.

28. A percutaneous electrical therapy system, comprising:

a housing configured to removably receive an actuator tool, the housing having a surface positioned to be removably placed against the skin of a recipient;

an electrode electrically connectable to a control unit, the electrode having a sharp point configured to be inserted into the recipient'"'"'s tissue, the electrode being positioned to make electrical contact with the actuator tool when the actuator tool is received by the housing;

an actuator carrying the electrode, the actuator being movable relative to the housing between a first position with the electrode stowed in the housing and a second position with the electrode deployed from the housing; and

an electrode depth control assembly configured to engage the actuator and control insertion of the sharp point of the electrode to a predetermined depth in the recipient'"'"'s tissue.

29. The system of claim 28, further comprising an actuator tool releasably engageable with the actuator to move the actuator and the electrode relative to the housing.

30. The system of claim 28, wherein the surface of the housing includes an adhesive patch positioned to releasably adhere to the recipient'"'"'s skin.

31. A percutaneous electrical therapy system, comprising:

a housing;

an electrode electrically connectable to a control unit, the electrode having a sharp point configured to be inserted into the recipient'"'"'s tissue;

an actuator carrying the electrode, the actuator being movable relative to the housing between a first position with the electrode stowed in the housing and a second position with the electrode deployed from the housing;

an electrode depth control assembly configured to control insertion of the sharp point of the electrode to a predetermined depth in the recipient'"'"'s tissue; and

an actuator tool removably engaged with the actuator to move the actuator between the first position and the second position, wherein the actuator tool makes electrical contact with the electrode when the actuator tool is engaged with the actuator.