Percutaneous electrical therapy system with electrode entry angle control

• US 6,622,051 B1
• Filed: 12/01/1999
• Issued: 09/16/2003
• 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): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/452,477
• Time in Patent Office: 1,385 Days
• Field of Search: 607/116, 607/1, 607/2, 607/46, 600/372, 600/373, 600/377, 606/129, 606/108
• US Class Current: 607/116
• 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, wherein the system includes a control unit; an electrode electrically connectable to the control unit to deliver electrical therapy to a patient, the electrode having a sharp point at a distal end adapted to be inserted into a patient'"'"'s tissue; and an electrode angle of insertion assembly controlling the electrode'"'"'s angle of entry into the patient'"'"'s tissue. The invention also includes the percutaneous electrode and electrode angle of insertion assembly described above apart from the control unit.

The invention is also a method of performing percutaneous electrical therapy including the steps of: aligning an electrode assembly housing with a patient'"'"'s tissue; inserting a sharp point of an electrode into the patient'"'"'s tissue, the housing supporting the electrode during insertion to control the electrode'"'"'s angle of insertion; and applying an electrical signal to the electrode from a control unit.

Claims

1. A percutaneous electrical therapy system, comprising:

a control unit configured to transmit an electrical therapy signal;

an electrode electrically connectable to the control unit to deliver electrical therapy to a recipient, the electrode having a sharp point at a distal end configured to be inserted into tissue of the recipient;

a housing having an actuator supporting the electrode and configured to control an angle of entry of the electrode into the tissue as the electrode moves relative to the housing, the housing having an aperture positioned to allow the electrode to pass through the housing into the tissue, the housing having an adhesive patch positioned to contact the tissue and releasably secure the housing to the tissue; and

a mechanical connection between the electrode and the housing during insertion of the electrode into the patient'"'"'s tissue, wherein the housing is adapted to be separated from the electrode after insertion of the electrode into the patient'"'"'s tissue but before application of electrical therapy to the patient.

2. The system of claim 1 wherein the housing comprises a distal face adapted to be placed on the patient to control the angle between the housing and the patient.

3. The system of claim 2 wherein the housing further comprises an aperture in the distal face, the aperture being adapted to surround at least a portion of the electrode during insertion of the electrode into the patient'"'"'s tissue.

4. The system of claim 2 wherein the distal face has a diameter greater than the housing'"'"'s diameter.

5. The system of claim 1 wherein the electrode is adapted to move with respect to the housing during insertion of the electrode into the patient'"'"'s tissue.

6. The system of claim 1 wherein the electrode and the housing are adapted to remain mechanically connected during application of electrical therapy to the patient.

7. The system of claim 1 wherein the electrode angle of insertion assembly further comprises a housing alignment member configured to be disposed on the patient'"'"'s tissue and adapted to mechanically interact with the housing to align the housing with respect to the patient'"'"'s tissue.

8. The system of claim 7 wherein the housing alignment member comprises a patch configured to be attached to the patient'"'"'s tissue.

9. The system of claim 8 wherein the patch comprises an annular member adapted to mate with the housing and to surround the electrode during insertion of the electrode into the patient'"'"'s tissue.

10. A method of performing percutaneous electrical therapy comprising:

aligning an electrode assembly housing with a patient'"'"'s tissue;

releasably attaching the housing to the patient'"'"'s tissue with an adhesive patch;

inserting a sharp point of an electrode into the patient'"'"'s tissue, the housing having an actuator supporting the electrode during insertion to control the electrode'"'"'s angle of insertion; and

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

removing the housing from the electrode after inserting the electrode and before applying the electrical signal to the electrode from the control unit.

11. A percutaneous electrical therapy system, comprising:

a control unit configured to transmit an electrical therapy signal;

an electrode electrically connectable to the control unit to deliver electrical therapy to a recipient, the electrode having a sharp point at a distal end configured to be inserted into tissue of the recipient; and

a housing having an actuator supporting the electrode and configured to control an angle of entry of the electrode into the tissue as the electrode moves relative to the housing, the housing having an aperture positioned to allow the electrode to pass through the housing into the tissue, the housing having an adhesive patch positioned to contact the tissue and releasably secure the housing to the tissue, wherein the housing is separable from the electrode after the electrode is inserted into the tissue but before electrical therapy is administered to the patient.

12. A percutaneous electrical therapy system, comprising:

a control unit configured to transmit an electrical therapy signal;

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

an electrode angle of insertion assembly configured to control the electrode'"'"'s angle of entry into the patient'"'"'s tissue, the electrode angle of insertion assembly comprising a housing supporting the electrode during insertion of the electrode into the patient'"'"'s tissue, the housing being adapted to be separated from the electrode after insertion of the electrode into the patient'"'"'s tissue but before application of electrical therapy to the patient, the electrode angle of insertion assembly further comprising a housing alignment member configured to be disposed on the patient'"'"'s tissue and adapted to mechanically interact with the housing to align the housing with respect to the patient'"'"'s tissue, the housing alignment member comprising a patch configured to be attached to the patient'"'"'s tissue; and

a mechanical connection between the electrode and the housing during insertion of the electrode into the patient'"'"'s tissue.

13. The system of claim 12 wherein the patch comprises an annular member adapted to mate with the housing and to surround the electrode during insertion of the electrode into the patient'"'"'s tissue.