Percutaneous flat lead introducer

• US 20050049664A1
• Filed: 02/05/2004
• Published: 03/03/2005
• Est. Priority Date: 08/29/2003
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Klein, Joseph J., Harris, Charmaine K.
• Granted Patent: US 8,340,779 B2
• Time in Patent Office: Days
• US Class Current: 607/115
• 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 the 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 sheath comprises a material that is substantially deformable.

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

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

9. The stimulation lead introducer of claim 8, wherein the 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.

16. A method for introducing a stimulation lead comprising:

inserting a stimulation lead introducer into an epidural region proximate a spine of a patient via a guidewire, wherein the introducer includes;

an elongated dilator defining a dilator lumen sized to advance over the 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 the stimulation lead;

withdrawing the dilator from the sheath; and

introducing a stimulation lead to a target site within the epidural region via the sheath.

17. The method of claim 16, further comprising:

inserting a needle with a stylet into the epidural region proximate a spine of a patient;

withdrawing the stylet from the needle;

inserting the guidewire into the needle such that a distal end of the guidewire extends to the target site within the epidural region;

withdrawing the needle;

inserting the stimulation lead introducer into the patient via the guidewire following withdrawal of the needle;

withdrawing the guidewire; and

introducing the stimulation lead via the sheath following withdrawal of the dilator and the guidewire.

18. The method of claim 17, further comprising withdrawing the sheath.

19. The method of claim 17, further comprising activating the stimulation lead to stimulate a nerve.

20. The method of claim 17, further comprising attaching a syringe to the needle, prior to inserting the guidewire into the needle, and attempting to inject fluid into the epidural region via the syringe and the needle to evaluate a position of the needle.

21. The method of claim 17, further comprising using an imaging technique to visualize introduction of the stimulation lead.

22. The method of claim 21, wherein the imaging technique comprises fluoroscopic imaging.

23. The method of claim 17, wherein the needle is a Tuohy needle.

24. The method of claim 16, wherein the sheath has a substantially oblong cross-section.

25. The method of claim 16, 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.

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

27. The method of claim 16, wherein the sheath lumen has a substantially oblong cross-section.

28. The method of claim 16, wherein the sheath comprises a material that is substantially deformable.

29. The method of claim 28, wherein the material is polyethylene.

30. The method of claim 16, wherein the dilator comprises a material that is substantially deformable.

31. The method of claim 30, wherein the material is polyethylene.

32. The method of claim 16, wherein the dilator is at least as long as the sheath.

33. The method 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.

34. The method of claim 16, 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.

35. The method of claim 34, wherein the width of the proximal opening is greater than or equal to approximately three times the height of the proximal opening.

36. The method of claim 16, wherein the sheath includes radiopaque material that is viewable under fluoroscopic imaging.

37. The method of claim 16, 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.

38. 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.

39. The dilator of claim 38, wherein the dilator is formed from a material that is substantially deformable.

40. The dilator of claim 39, wherein the material is polyethylene.

41. The dilator of claim 38, wherein the dilator lumen has a substantially oblong cross-section.

42. The dilator of claim 38, 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.

43. The dilator of claim 42, wherein the width of the proximal opening is greater than or equal to approximately three times the height of the proximal opening.