Pacing lead stylet

• US 4,796,642 A
• Filed: 12/28/1987
• Issued: 01/10/1989
• Est. Priority Date: 12/28/1987
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Cordis Leads Incorporated
• Inventors: Harris, Donald L.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US07/138,434
• Time in Patent Office: 379 Days
• Field of Search: 128/657, 128/772, 128/785, 128/786, 128/348.1, 604/95, 604/164, 604/166, 604/170, 604/171
• US Class Current: 600/585
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

The pacing lead stylet includes a proximal end, a stylet wire, a decreasing taper, a flat, an increasing taper and a tip. The decreasing taper is connected to the stylet wire and extends in a distal direction away from the wire distal end for a decreasing taper distance. The decreasing taper has a decreasing cross section which is reduced from the stylet cross sectional area to a decreased cross sectional area at a decreasing taper distal end of the decreasing taper. The flat is connected to the decreasing taper and extends in a distal direction away from the decreasing taper distal end for a flat distance to a flat distal end. The increasing taper is connected to the flat and extends in a distal direction away from the flat distal end for an increasing taper distal. The increasing taper has an increasing cross section from the minimum extension to the stylet cross section area. The tip is connected to the increasing taper extends in a distal direction away from the increasing taper for a predetermined distance, preferably equal to at least three pitch distances of a helical coil of the pacing lead. The tip has a generally constant tip cross section area except at a tip distal end which is hemispherical. The tip distal end has a maximum hemispherical cross section area nearly equal to the tip cross section area, and has a hemispherical radius of curvature larger than half a maximum tip cross section.

Claims

1. A pacing lead stylet for insertion into a pervenous pacing lead for facilitating insertion of the lead into a patient, the pervenous pacing lead including at least one helical coil in an insulating sheath surrounding a lumen, the lumen being open at a proximal end of the pacing lead and extending to a distal end of the pacing lead where it is generally closed by a pacing lead electrode assembly, said stylet comprising:

a proximal end adapted for manipulation;

a distal end;

a stylet wire connected to said proximal end and extending in distal direction from the proximal end to said distal end and having an axial length sufficient to nearly contact the pacing lead electrode assembly with said stylet distal end, when said stylet wire is fully inserted into the lumen, said stylet wire having a generally constant stylet cross sectional area;

a decreasing taper connected to said stylet wire and extending in a distal direction away from the wire distal end for a decreasing taper distance, said decreasing taper having a decreasing cross section which is reduced from the stylet cross sectional area to a decreased cross sectional area at a decreasing taper distal end of said decreasing taper;

a flat connected to said decreasing taper and extending in a distal direction away from the decreasing taper distal end for a flat distance to a flat distal end, said flat having a cross section which has a maximum extent and a minimum extent;

an increasing taper connected to said flat and extending in a distal direction away from said flat distal end for an increasing taper distance, said increasing taper having an increasing cross section from the minimum extent of the flat to the stylet cross section area; and

a tip at said stylet distal end connected to said increasing taper extending in a distal direction away from said increasing taper for a predetermined distance, said tip having a generally constant tip cross section area except at a tip distal end which is hemispherical, has a maximum hemispherical cross section area nearly equal to the tip cross section area, and has a hemispherical radius of curvature larger than half a maximum tip cross section.

2. The pacing lead stylet of claim 1 wherein:

said decreasing taper, said flat and said increasing taper overlap for portions of their respective distances.

3. The pacing lead stylet of claim 2 wherein:

said flat overlaps the distal third of said decreasing taper, and overlaps the proximal third of said increasing taper.

4. The pacing lead stylet of claim 1 wherein:

said decreasing taper has a decreasing taper distance which is at least six times a maximum cross section of said stylet wire.

5. The pacing lead stylet of claim 4 wherein:

said decreasing taper, said flat and said increasing taper overlap for portions of their respective distances.

6. The pacing lead stylet of claim 5 wherein:

said flat overlaps the distal third of said decreasing taper, and overlaps the proximal third of said increasing taper.

7. The pacing lead stylet of claim 6 wherein:

said increasing taper has an increasing taper distance which is less than three times the maximum cross section of said stylet wire.

8. The pacing lead stylet of claim 7 wherein:

said flat has a flat distance which is about twenty times the maximum cross section of said stylet wire.

9. The pacing lead stylet of claim 8 wherein:

said stylet wire has a generally circular cross section;

said decreasing taper has a generally conical cross section with the cone apex at its distal end; and

said increasing taper has a generally conical cross section with the cone apex at a proximal end.

10. The pacing lead stylet of claim 9 wherein:

said flat has a maximum extent approximately equal to the diameter of said stylet wire.

11. The pacing lead stylet of claim 10 wherein:

said flat has a minimum extent approximately one third of the maximum extent.

12. The pacing lead stylet of claim 1 for use with a pacing lead having at least one helically coiled wire conductor with each coil or turn having a predetermined pitch, a specific pitch distance between turns, and wherein said tip has a length equal to at least three pitch distances.

13. A pacing lead stylet for insertion into a pervenous pacing lead for facilitating insertion of the lead into a patient, the pervenous pacing lead including at least one helical coil in an insulating sheath surrounding a lumen, the lumen being open at a proximal end of the pacing lead and extending to a distal end of the pacing lead where it is generally closed by a pacing lead electrode assembly, the helical coil having a specific pitch distance between adjacent turns, said stylet comprising:

a proximal end adapted for manipulation;

a distal end;

a stylet wire connected to said proximal end and extending in distal direction from the proximal end and having an axial length sufficient to nearly contact the pacing lead electrode with said stylet distal end, when said stylet wire is fully inserted into the lumen, said stylet wire having a generally constant wire cross sectional area, and having a cross section wire maximum extent and a wire minimum extent;

a decreasing taper connected to said stylet wire and extending in a distal direction away from the wire distal end for a decreasing taper distance, said decreasing taper having a decreasing cross section which is reduced from the stylet cross sectional area to a decreased cross sectional area at a decreasing taper distal end of said decreasing taper;

a flat connected to said decreasing taper and extending in a distal direction away from the decreasing taper distal end for a flat distance to a flat distal end, said flat having a cross section which has a flat maximum extent and a flat minimum extent, the flat minimum extent being approximately one third of the wire maximum extent;

an increasing taper connected to said flat and extending in a distal direction away from said flat distal end for an increasing taper distance, said increasing taper having an increasing cross section from the flat minimum extent to the wire cross section area; and

a tip connected to said increasing taper extending in a distal direction away from said increasing taper for a distance equal to at least three pitch distances said tip having a generally constant tip cross section area approximately equal to the wire cross sectional area except at a tip distal end which is hemispherical, has a maximum hemispherical cross section area nearly equal to the tip cross section area, and has a hemispherical radius of curvature larger than half a maximum tip cross section.

14. The pacing lead stylet of claim 13 wherein:

said decreasing taper has a decreasing taper distance which is at least six times the wire minimum extent.

15. The pacing lead stylet of claim 14 wherein:

said decreasing taper, said flat and said increasing taper overlap for portions of their respective distances.

16. The pacing lead stylet of claim 15 wherein:

said flat overlaps the distal third of said decreasing taper, and overlaps the proximal third of said increasing taper.

17. The pacing lead stylet of claim 16 wherein:

said increasing taper has an increasing taper distance which is less than two thirds the decreasing taper distance.

18. The pacing lead stylet of claim 17 wherein:

said flat has a flat distance which is about twenty times the maximum cross section of said stylet wire.

19. A pacing lead stylet for insertion into a pervenous pacing lead for facilitating insertion of the lead into a patient, the pervenous pacing lead including at least one helical coil in an insulating sheath surrounding a lumen, the lumen being open at a proximal end of the pacing lead and extending to a distal end of the pacing lead where it is generally closed by a pacing lead electrode assembly, the helical coil having a specific pitch distance between adjacent turns, said stylet comprising:

a proximal end adapted for manipulation;

a distal end;

a cylindrical stylet wire connected to said proximal end and extending in distal direction from the proximal end and having an axial length sufficient to nearly contact the pacing lead electrode assembly with said stylet distal end, when said stylet wire is fully inserted into the lumen, said stylet wire having a generally constant wire diameter;

a decreasing taper connected to said stylet wire and extending in a distal direction away from the wire distal end for a decreasing taper distance, said decreasing taper having a decreasing cross section which is reduced for the wire diameter to a decreased taper diameter at a decreasing taper distal end of said decreasing taper;

a flat connected to said decreasing taper and extending in a distal direction away from the decreasing taper distal end for a flat distance to a flat distal end, said flat having a cross section which has a flat maximum extent being approximately equal to the wire diameter and a flat minimum extent, the flat minimum extent being approximately one third of the wire diameter;

an increasing taper connected to said flat and extending in a distal direction away from said flat distal end for an increasing taper distance, said increasing taper having an increasing cross section from the flat minimum extent to the wire diameter; and

a cylindrical tip connected to said increasing taper extending in a distal direction away from said increasing taper for a distance equal to at least three pitch distances said tip having a generally constant tip diameter approximately equal to the wire diameter except at a tip distal end which is hemispherical, has a maximum hemispherical cross section area nearly equal to the tip cross section area, and has a hemispherical radius of curvature larger than half the wire diameter.