Implantable, expandable, multicontact electrodes and insertion needle for use therewith

• US 6,415,187 B1
• Filed: 02/07/2001
• Issued: 07/02/2002
• Est. Priority Date: 02/10/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Kuzma, Janusz A., Mann, Carla M.
• Primary Examiner(s): Layno, Carl
• Application Number:
  US09/778,267
• Time in Patent Office: 510 Days
• Field of Search: 607/116, 607/117, 607/142, 607/152, 607/43
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

A paddle-type electrode or electrode array is implantable like a percutaneously inserted lead, i.e., without requiring major surgery. Once implanted, the electrode array provides a platform for many electrode configurations. In a preferred embodiment, the electrode array is provided on a flexible, foldable or compressible, subcarrier or substrate. Such subcarrier or substrate folds or compresses during implantation, thereby facilitating its insertion using an insertion needle. Once implanted, such subcarrier or substrate expands, thereby placing the electrodes in a desired spaced-apart positional relationship, and thus achieving a desired electrode array configuration. The insertion needle has a lumen with a non-circular cross-sectional shape, e.g., having a width greater than its height, to facilitate sliding the folded or compressed paddle-type electrode array therein.

Claims

1. An implantable electrode array comprising:

a foldable paddle having a perimeter edge and including a plurality of electrode contacts arranged in a spaced-apart relationship along the perimeter edge;

a shape-memory wire made from a metal or a polymer formed in the perimeter edge of the foldable paddle, said shape-memory wire assuming a desired shape in the absence of external forces, said shape-memory wire having flexible properties that allow the shape-memory wire to bend and fold when subjected to external forces;

means for making electrical contact with each of the plurality of electrode contacts; and

an opening in the foldable paddle;

wherein the electrode array may be folded to assume a small cross-sectional area during implantation, but whereby the electrode array unfolds to assume an expanded configuration as controlled by the desired shape of the shape-memory wire after implantation; and

wherein an attachment loop of the shape-memory wire is exposed in the opening of the foldable paddle, which attachment loop is usable with an insertion stylet to help position the electrode array during implantation.

2. A system for implanting an expandable electrode array comprising:

an electrode array, the electrode array comprising;

a flexible substrate,

a plurality of parallel columns of spaced-apart electrodes integrally formed on a surface of the flexible substrate, and

means for making electrical contact with each electrode in each of the plurality of parallel columns of electrodes,

the flexible substrate normally assuming a planar flat shape, but being collapsible so as to configure the electrode array in a folded or compressed state;

an insertion tube adapted to facilitate implantation of the electrode array into living tissue while still in its folded or compressed state, wherein the insertion tube has a lumen passing longitudinally therethrough having a width L1 and a height L2, where L1 is not equal to L2, and wherein the electrode array, when in its folded or compressed state, may be inserted into the lumen; and

wherein the insertion tube further comprises a loading element detachably connected to a proximal end of the lumen, the loading element having a funnel-shape that facilitates configuring the electrode array in its folded or compressed state from its planar flat state as the electrode array is longitudinally inserted into the lumen.

3. A system for implanting an expandable electrode array comprising:

an electrode array, the electrode array comprising;

a flexible substrate,

a plurality of parallel columns of spaced-apart electrodes integrally formed on a surface of the flexible substrate, and

means for making electrical contact with each electrode in each of the plurality of parallel columns of electrodes,

the flexible substrate normally assuming a planar flat shape, but being collapsible so as to configure the electrode array in a folded or compressed state;

an insertion tube adapted to facilitate implantation of the electrode array into living tissue while still in its folded or compressed state, wherein the insertion tube has a lumen passing longitudinally therethrough having a width L1 of about 4 mm and a height L2 of about 3 mm, and wherein the electrode array, when in its folded or compressed state, may be inserted into the lumen; and

wherein the insertion tube comprises an insertion needle having a sharp distal tip that facilitates its insertion into living tissue.

4. A method of percutaneously implanting a paddle-type electrode array through the lumen of a needle, comprising:

forming a paddle-type electrode array having a plurality of spaced apart electrodes on a flexible membrane;

making an insertion needle having a lumen passing longitudinally therethrough, the lumen having dimensions adapted to allow the paddle-type electrode array to be received therein, and further having a sharp distal tip;

inserting the paddle-type electrode array into the lumen of the insertion needle;

injecting the insertion needle in living tissue;

expelling the paddle-type electrode array from the lumen of the insertion needle so that the paddle-type electrode array is positioned within the living tissue.

5. The method of claim 4 wherein the step of inserting the paddle-type electrode array in the lumen of the insertion needle comprises folding the paddle-type electrode array and inserting the folded paddle-type electrode array into the lumen of the insertion needle.

6. The method of claim 4 wherein the step of inserting the paddle-type electrode array in the lumen of the insertion needle comprises compressing the paddle-type electrode array and inserting the compressed paddle-type electrode array into the lumen of the insertion needle.

7. The method of claim 4 wherein the step of making an insertion needle comprises making the insertion needle with a lumen, wherein the lumen has a width L1 and a height L2, wherein L1 is not equal to L2.

8. The method of claim 7 wherein the step of making an insertion needle comprises making the insertion needle with a lumen, wherein the lumen has a width of about 4 mm and a height of about 3 mm.

9. A method of percutaneously inserting a paddle-type electrode array into the spinal cord cavity of a patient, comprising:

forming an insertion needle having a sharp distal tip and a lumen passing longitudinally therethrough, the lumen having a proximal opening and a distal opening, and further having a non-circular cross sectional shape that allows the paddle-type electrode array to be received therein;

sliding the paddle-type electrode array into the lumen through the proximal opening of the lumen;

inserting the insertion needle, with the paddle-type electrode array located within the lumen, through the patient'"'"'s tissue until the distal tip is near the spinal cord cavity; and

expelling the paddle-type electrode array from the distal tip of the lumen of the insertion needle so that the paddle-type electrode array is positioned within the spinal cord cavity.

10. The method of claim 9 wherein expelling the paddle-type electrode array from the lumen comprises pushing the paddle-type electrode array out of the distal opening of the lumen.

11. The method of claim 10 wherein expelling the paddle-type electrode array from the lumen comprises inserting a stylet through the lumen of the needle so as to engage a distal portion of the paddle-type electrode array while still within the lumen of the needle, and then pushing the stylet, while retracting the needle, to thereby expel the paddle-type electrode array from the distal opening of the lumen.

12. The method of claim 9 wherein sliding the paddle-type electrode array into the lumen through the proximal opening of the lumen comprises folding the paddle-type electrode array so that it slidingly fits within the non-circular cross sectional shape of the lumen of the needle, and then sliding the folded paddle-type electrode array into the lumen.

13. The method of claim 9 wherein sliding the paddle-type electrode array into the lumen through the proximal opening of the lumen comprises compressing the paddle-type electrode array so that it slidingly fits within the non-circular cross sectional shape of the lumen of the needle, and then sliding the compressed paddle-type electrode array into the lumen.