Apparatus and method for percutaneous implant of a paddle style lead

• US 6,309,401 B1
• Filed: 04/30/1999
• Issued: 10/30/2001
• Est. Priority Date: 04/30/1999
• Status: Expired due to Fees

• Current Assignee: Kenneth M. Alo, Vladimir Redko
• Original Assignee: Kenneth M. Alo, Vladimir Redko
• Inventors: Redko, Vladimir, Alo, Kenneth M.
• Primary Examiner(s): Recla, Henry J.
• Assistant Examiner(s): HO, TAN-UYEN THI
• Application Number:
  US09/302,694
• Time in Patent Office: 914 Days
• Field of Search: 606/185, 606/15, 607/117, 607/116, 607/115, 604/105, 604/272, 604/273, 604/274, 604/181, 604/187, 604/264
• US Class Current: 606/185
• CPC Class Codes: A61B 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61M 25/065 Guide needles
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

A needle and method for introduction of a paddle style lead near a spinal column or other nervous system structures, central or peripheral, of a patient includes a body having a proximal end and a distal end, and a lumen with a continuous oblong cross section. The distal end of the body has an introducer portion where the top side of the introducer has an orifice to allow for protrusion of the paddle style lead from the lumen into the spinal column area or into or near other nervous system structures. The needle has a hub affixed to the proximal end of the body which is adapted to receive a stylet. The needle may also have a stylet that is inserted within the lumen. The introducer of the needle has a curvature extending from the bottom side toward the top side at the distal end and guides the introduction of the paddle style lead near the spinal column or other nervous system structures.

Claims

1. A needle for introduction of a paddle style lead near a spinal column or into or near nervous system structures of a patient, comprising, in combination:

a body having a proximal end and a distal end,

a lumen having a continuous oblong cross section defined by a solid outer wall, and

a stylet having a handle end at a proximal end, a solid body extending from the proximal end to the distal end and adapted to be inserted within the lumen.

2. The needle of claim 1, wherein the distal end is further defined by an introducer portion having a top side and a bottom side, the top side of the introducer having an orifice to allow for protrusion of the paddle style lead from the lumen.

3. The needle of claim 2, wherein the introducer has a curvature extending from the bottom side toward the top side at the distal end to provide a guide for introduction of the paddle style lead near the spinal column or into or near nervous system structures.

4. The needle of claim 3, wherein the stylet fills in the top side of the introducer element preventing tissue from entering the lumen during insertion.

5. The needle of claim 1, wherein the body is further defined by a hub affixed to the proximal end of the body adapted to receive the stylet.

6. The needle of claim 1, wherein the hub is a Luer lock.

7. The needle of claim 1, wherein the stylet fills in the distal end of the body preventing tissue from entering the lumen during insertion.

8. A needle for introduction of a paddle style lead near a spinal column or into or near nervous system structures of a patient, comprising, in combination:

a body having a proximal end and a distal end,

a lumen having a continuous oblong cross section defined by a solid outer wall,

the paddle style lead having a lead body and wires connected at a transition area adapted to be inserted through the oblong cross section of the lumen.

9. The needle of claim 8, wherein the combination further comprises at least two wire leads adapted to be inserted through the oblong cross section of the lumen.

10. A needle for introduction of a paddle style lead near a spinal column or into or near nervous system structures of a patient, comprising, in combination:

a body having a proximal end and a distal end,

a lumen having a continuous oblong cross section defined by a solid outer wall, wherein the distal end is further defined by an introducer portion having a top side and a bottom side,

the top side of the introducer portion having an orifice to allow for protrusion of the paddle style lead from the lumen;

a hub affixed to the proximal end of the body adapted to receive a stylet, and

the stylet having a handle end at a proximal end, a solid body extending from the proximal end to the distal end and adapted to be inserted within the lumen.

11. The needle of claim 10, wherein the introducer has a curvature extending from the bottom side toward the top side at the distal end to provide a guide for introduction of the paddle style lead near the spinal column or into or near nervous system structures.

12. The needle of claim 10, wherein the hub is a Luer lock.

13. The needle of claim 10, wherein the stylet fills in the top side of the introducer element preventing tissue from entering the lumen during insertion.

14. A needle for introduction of a paddle style lead near a spinal column or into or near nervous system sues of a patient comprising, in combination:

a body having a proximal end and a distal end,

a lumen having a continuous oblong cross section defined by a solid outer wall, wherein the distal end is further defined by an introducer portion having a top side and a bottom side,

the top side of the introducer portion having an orifice to allow for protrusion of the paddle style lead from the lumen,

a hub affixed to the proximal end of the body adapted to receive a stylet, and

the paddle style lead having a lead body and wires connected at a transition area adapted to be inserted through the oblong cross section of the lumen.

15. The needle of claim 14, wherein the combination further comprises at least two wire leads adapted to be inserted through the oblong cross section of the lumen.

16. A needle for introduction of a paddle style lead near a spinal column or into or near nervous system structures of a patient, comprising, in combination:

a body having a proximal end and a distal end, and a lumen having a continuous oblong cross section, wherein the distal end is further defined by an introducer portion having a top side and a bottom side, the top side of the introducer having an orifice to allow for protrusion of the paddle style lead from the lumen, the introducer having a curvature extending from the bottom side toward the top side at the distal end to provide a guide for introduction of the paddle style lead near the spinal column or into or near nervous system structures;

a hub affixed to the proximal end of the body adapted to receive a stylet; and

a stylet having a handle end at a proximal end and adapted to be insertable within the lumen, wherein the stylet fills in the top side of the introducer element preventing tissue from entering the lumen during insertion.

17. The needle of claim 16, wherein the combination further comprises a paddle style lead having a lead body and wires connected at a transition area adapted to be inserted through the oblong cross section of the lumen.

18. The needle of claim 16, wherein the combination further comprises at least two wire leads adapted to be inserted through the oblong cross section of the lumen.

19. A needle for introduction of a paddle style lead near a spinal column or into or near nervous system structures of a patient, comprising, in combination:

a body having a primal end and a distal end, and a lumen having a continuous oblong cross section defined by a solid outer wall, wherein the distal end is further defined by an introducer portion having a top side and a bottom side, the top side of the introducer having an orifice to allow for protrusion of the paddle style lead from the lumen, the introducer having a curvature extending from the bottom side toward the top side at the distal end to provide a guide for introduction of the paddle style lead near the spinal column or into or near nervous system structures;

a hub affixed to the proximal end of the body adapted to receive a stylet;

a stylet having a handle end at a proximal end and adapted to be inserted within the lumen, wherein the stylet fills in the top side of the introducer element preventing tissue from entering the lumen during insertion; and

the paddle style lead having a lead body and wires connected at a transition area adapted to be inserted through the oblong cross section of the lumen.

20. A needle for introduction of a paddle style lead near a spinal column or into or near nervous system structures of a patient, comprising, in combination;

a body having a proximal end and a distal end, and a lumen having a continuous oblong cross section defined by a solid outer wall wherein the distal end is further defined by an introducer portion having a top side and a bottom side, the top side of the introducer having an orifice to allow for protrusion of the paddle style lead from the lumen, the introducer having a curvature extending from the bottom side toward the, top side at the distal end to provide a guide for introduction of the paddle style lead near the spinal column or into or near nervous system structures;

a hub affixed to the proximal end of the body adapted to receive a stylet;

a stylet having a handle end at a proximal end and adapted to be insertable within the lumen, wherein the stylet fills in the top side of the introducer element preventing tissue from entering the lumen during insertion; and

at least two wire leads adapted to be inserted through the oblong cross section of the lumen.