Percutaneous flat lead introducer

• US 20080009929A1
• Filed: 06/28/2007
• Published: 01/10/2008
• Est. Priority Date: 08/29/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Klein, Joseph, Harris, Charmaine
• Granted Patent: US 8,386,052 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• 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 25/0102 Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
• CPC Class Codes: A61M 25/06 Body-piercing guide needles or the like
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 29/00 Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

In general, the invention is directed to a technique for percutaneously introducing a stimulation lead into a target stimulation site via the epidural region proximate the spine of a patient. The process of introducing the stimulation lead may include the use of a hollow stimulation lead introducer, which comprises an elongated sheath and an elongated dilator. The dilator fits within the sheath and serves to widen a path through the epidural region for the introduction of a stimulation lead. At least a portion of the stimulation lead introducer has an oblong cross-section, allowing passage of stimulation leads such as paddle leads. The stimulation lead introducer may enter the epidural region proximate a spine of a patient via a guidewire. The stimulation lead introducer provides a path through the epidural region of a patient to a target stimulation site. A stimulation lead may travel through the path to reach the target stimulation site where it may provide therapy to the patient.

Claims

1. A stimulation lead introducer comprising:

an elongated dilator defining a dilator lumen sized to advance over a guidewire, the dilator having a substantially conical distal tip, wherein at least a portion of the conical distal tip has a substantially oblong cross-section; and

an elongated sheath defining a sheath lumen sized to accommodate the dilator or a stimulation lead.

2. The stimulation lead introducer of claim 1, wherein the sheath has a substantially oblong cross-section.

3. The stimulation lead introducer of claim 1, wherein the sheath has a substantially oblong cross-section with a width of the cross-section of the sheath that is greater than approximately two times a height of the cross-section of the sheath.

4. The stimulation lead introducer of claim 1, wherein the dilator lumen has a substantially oblong cross-section.

5. The stimulation lead introducer of claim 1, wherein the sheath lumen has a substantially oblong cross-section.

6. The stimulation lead introducer of claim 1, wherein the dilator comprises a dilator material that is substantially deformable.

7. The stimulation lead introducer of claim 6, wherein the dilator material is polyethylene.

8. The stimulation lead introducer of claim 1, wherein the sheath comprises a sheath material that is substantially deformable.

9. The stimulation lead introducer of claim 8, wherein the sheath material is polyethylene.

10. The stimulation lead introducer of claim 1, wherein the dilator is at least as long as the sheath.

11. The stimulation lead introducer of claim 1, wherein the substantially conical distal tip comprises a proximal opening and a distal opening, the proximal opening having a substantially oblong cross-section and the distal opening having a substantially circular cross-section.

12. The stimulation lead introducer of claim 1, wherein the substantially conical distal tip comprises a proximal opening having an oblong cross-section such that a width of the proximal opening is greater than a height of the proximal opening.

13. The stimulation lead introducer of claim 12, wherein the width of the proximal opening is greater than or equal to approximately three times the height of the proximal opening.

14. The stimulation lead introducer of claim 1, wherein the sheath includes radiopaque material that is viewable under fluoroscopic imaging.

15. The stimulation lead introducer of claim 1, wherein the sheath lumen has a cross-section with a width of the cross-section of the sheath lumen that is greater than approximately two times a height of the cross-section of the sheath lumen.

22. The stimulation lead introducer of claim 1, wherein a width of an outside of the sheath is within a range from approximately 5.21 millimeters to approximately 7.75 millimeters, and a height of the outside of the sheath is within a range from approximately 3.05 millimeters to approximately 3.56 millimeters.

23. The stimulation lead introducer of claim 1, wherein the dilator and the sheath are sized for insertion into an epidural region of a patient.

16. A dilator for widening a path for a stimulation lead to travel through an epidural region proximate a spine of a patient, the dilator having a proximal end and a distal end, wherein the dilator defines a dilator lumen sized to advance over a guidewire, the dilator having a substantially conical distal tip, wherein at least a portion of the conical distal tip has a substantially oblong cross-section.

17. The dilator of claim 16, wherein the dilator is formed from a material that is substantially deformable.

18. The dilator of claim 17, wherein the material is polyethylene.

19. The dilator of claim 16, wherein the dilator lumen has a substantially oblong cross-section.

20. The dilator of claim 16, wherein the substantially conical distal tip comprises a proximal opening and a distal opening, the proximal opening having a substantially oblong cross-section and the distal opening having a substantially circular cross-section.

21. The dilator of claim 20, wherein the width of the proximal opening is greater than or equal to approximately three times the height of the proximal opening.

24. A kit comprising:

a stimulation lead introducer, wherein the stimulation lead introducer includes;

an elongated dilator defining a dilator lumen sized to advance over a guidewire, the dilator having a substantially conical distal tip, wherein at least a portion of the conical distal tip has a substantially oblong cross-section, and

an elongated sheath defining a sheath lumen sized to accommodate the dilator or a stimulation lead; and

the stimulation lead, wherein a distal end of the stimulation lead has a substantially oblong cross-section and includes at least one electrode.

25. The kit of claim 24, wherein the distal end of the stimulation lead has a substantially rectangular cross-section.

26. The kit of claim 24, wherein the distal end of the stimulation lead is substantially paddle-shaped.

27. The kit of claim 24, wherein a width of an outside of the sheath is within a range from approximately 5.21 millimeters to approximately 7.75 millimeters, and a height of the outside of the sheath is within a range from approximately 3.05 millimeters to approximately 3.56 millimeters, and the distal end of the stimulation lead has a width within a range from approximately 3.81 millimeters to approximately 4.32 millimeters and a height within a range from approximately 1.02 millimeters to approximately 1.40 millimeters.

28. The kit of claim 24, wherein the dilator and the sheath are sized to enter an epidural region of a patient.

29. The kit of claim 24, wherein the sheath comprises a material that is substantially deformable.