Telescopic, peel-away introducer and method of using the same

• US 20030208220A1
• Filed: 05/06/2002
• Published: 11/06/2003
• Est. Priority Date: 05/06/2002
• Status: Active Grant

• Current Assignee: Pressure Products Medical Supplies Incorporated
• Original Assignee: Pressure Products Medical Supplies Incorporated
• Inventors: Kurth, Paul, Worley, Seth J.
• Granted Patent: US 7,384,422 B2
• Time in Patent Office: Days
• US Class Current: 606/190
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

An introducer system is used for implantation of pacemaker leads into the venous system of the human heart through the coronary sinus. The system is comprised of three telescopic components, an inner telescoping core, a precurved inner telescoping sheath, and an outer telescoping sheath, introducer, guide or catheter. In an embodiment where a core is used it is torsionally stiff. In an embodiment where no core is used, the inner sheath is torsionally stiff. In either case, the member which is torsionally stiff is torqueable. In general, the inner sheath and outer guide will be both laterally and torsionally flexible, while the core will be torsionally stiff. The core and inner sheath, when curved together in the venous system and proximally coupled, will be sufficiently bound to each other that proximal rotation of the core will be coupled to and cause distal rotation of the inner sheath.

Claims

1. A telescopic introducer apparatus for use in the coronary sinus venous system comprising:

a flexible, elongate, outer sheath; and

a flexible, elongate, telescopic inner sheath slidingly disposed in the outer sheath, the inner sheath having a prebiased curvature for navigation with the venous system.

2. The telescopic introducer apparatus of claim 1 further comprising means for rotating a distal end of the inner sheath from a proximal end of the inner sheath so that the inner sheath is steerable within the venous system.

3. The telescopic introducer apparatus of claim 2 where the means for rotating a distal end of the inner sheath from a proximal end of the inner sheath so that the inner sheath is steerable within the venous system comprises a torsionally stiff core, and wherein the inner sheath is torsionally flexible.

4. The telescopic introducer apparatus of claim 3 wherein the inner sheath is unreinforced.

5. The telescopic introducer apparatus of claim 2 where the means for rotating a distal end of the inner guide from a proximal end of the inner guide so that the inner guide is steerable within the venous system comprises means for rendering the inner guide torsionally stiff.

6. The telescopic introducer apparatus of claim 5 where the means for rendering the inner guide torsionally stiff comprises braiding incorporated in or on the inner or outer sheath.

7. The telescopic introducer apparatus of claim 1 where the inner sheath has at least one longitudinal lumen defined therethrough adapted for injection of a fluid.

8. The telescopic introducer apparatus of claim 1 where the inner sheath has at least one longitudinal lumen defined therethrough adapted for disposition of a guide wire therethrough.

9. The telescopic introducer apparatus of claim 7 further comprising a proximal sidearm communicated to the at least one longitudinal lumen and a hemostatic valve coupled to and terminating the sidearm.

10. The telescopic introducer apparatus of claim 1 further comprising a distal radioopaque section or marker on the inner sheath.

11. The telescopic introducer apparatus of claim 3 further comprising a distal radioopaque section or marker on the core.

12. The telescopic introducer apparatus of claim 1 where the inner sheath comprises a proximal flexible unbiased portion and a distal precurved portion, which has a curvature for optimally steering the inner sheath into the coronary sinus venous system of the heart.

13. The telescopic introducer apparatus of claim 12 wherein the distal precurved portion has a single radius of curvature and a distal most straight portion.

14. The telescopic introducer apparatus of claim 13 wherein the inner sheath has a longitudinal axis and the single radius of curvature and relative length of the distal precurved portion are such that an open curve is obtained, an open curve being defined as having an angle between the direction of the longitudinal axis of the proximal portion of the inner sheath where it joins the precurved portion and the direction of the longitudinal axis at a distal end of the precurved portion of the inner sheath of more than 90°

.

15. The telescopic introducer apparatus of claim 13 wherein the inner sheath as a longitudinal axis and the single radius of curvature and relative length of the distal precurved portion are such that a closed curve is obtained, a closed curve being defined as having an angle between the direction of the longitudinal axis of the proximal portion of the inner sheath where it joins the precurved portion and the direction of the longitudinal axis at a distal end of the precurved portion of the inner sheath of less than 90°

.

16. The telescopic introducer apparatus of claim 12 where the precurved portion of the inner sheath comprises two curved subportions and a straight subportion therebetween of form a flattened hook.

17. The telescopic introducer apparatus of claim 16 where the two curved subportions comprise a proximal curved subportion having a radius of curvature of a first magnitude and a distal curved subportion having a radius of curvature of a second magnitude less than the first magnitude.

18. The telescopic introducer apparatus of claim 17 where the radius of curvature of the first magnitude is approximately 1 inch and where the radius of curvature of the second magnitude is approximately 0.2 to 0.3 inch.

19. The telescopic introducer apparatus of claim 1 where the outer guide or sheath is longitudinally openable or separable.

20. The telescopic introducer apparatus of claim 1 where the inner sheath is longitudinally openable or separable.

21. The telescopic introducer apparatus of claim 1 where the outer guide and inner sheath are both longitudinally openable or separable.

22. The telescopic introducer apparatus of claim 1 further comprising a distal balloon.

23. The telescopic introducer apparatus of claim 1 further comprising a proximal sidearm communicated to the at least one longitudinal lumen and a hemostatic valve coupled to and terminating the sidearm.

24. A telescopic introducer for use in the coronary sinus venous system comprising:

a flexible, elongate, nontorqueable sheath having a longitudinal lumen defined therein; and

an elongate, telescopic core slidingly disposed in the lumen of the sheath, the core being structurally reinforced so that it is torsionally stiff while remaining radially flexible by virtue of a structural reinforcement in or on the core, the core being adapted to rotationally couple with the sheath so that a distal end of the sheath is rotated when a proximal end of the core is rotated.

25. The telescopic introducer of claim 24 where the core is reinforced by a braid.

48. The telescopic introducer of claim 24 where the core and sheath are both shaped with at least similar shapes and where the rotational coupling between the core and sheath arises at least in part due the interference fit between the shaped core and sheath.

49. The telescopic introducer of claim 24 further comprising a first hub proximally connected to the sheath and a second hub proximally connected to the core and where the rotational coupling between the core and sheath arises at least in part due the coupling of the first and second hub.

50. The telescopic introducer of claim 24 where the rotational coupling between the core and sheath arises at least in part from the frictional contact between the lumen of the sheath and the core.

26. A method for use of a telescopic introducer in the coronary sinus venous system comprising:

disposing a flexible, elongate, outer sheath in the sinus venous system; and

slidingly disposing a flexible, elongate, telescopic inner sheath in the outer sheath; and

curving the inner sheath in the sinus venous system by means of a prebiased curvature.

27. The method of claim 26 further comprising rotating a distal end of the inner sheath from a proximal end of the inner sheath to steer the inner sheath within the venous system.

28. The method of claim 27 where rotating a distal end of the inner sheath from a proximal end of the inner sheath to steer the inner sheath within the venous system comprises rotating a torsionally stiff core, while the inner sheath remains torsionally flexible.

29. The method of claim 26 where the inner sheath has at least one longitudinal lumen defined therethrough and further comprising injecting a fluid therethrough.

30. The method of claim 26 where the inner sheath has at least one longitudinal lumen defined therethrough and further comprising disposing a guide wire through the lumen.

31. The method of claim 30 further comprising communicating a proximal sidearm to the at least one longitudinal lumen and to a hemostatic valve coupled to and terminating the sidearm.

32. The method of claim 26 further comprising providing a distal radioopaque section or marker on the inner sheath.

33. The method of claim 28 further comprising providing a distal radioopaque section or marker on the core.

34. The method of claim 26 where curving the inner sheath in the sinus venous system by means of a prebiased curvature comprises providing an inner sheath with a proximal flexible unbiased portion and a distal precurved portion, which has a curvature for optimally steering the inner sheath into the coronary sinus venous system of the heart.

35. The method of claim 34 wherein providing an inner sheath with a prebiased curvature provides the distal precurved portion with a single radius of curvature and a distal most straight portion.

36. The method of claim 35 wherein providing an inner sheath with a prebiased curvature provides the inner sheath with a longitudinal axis and the single radius of curvature and relative length of the distal precurved portion are such that an open curve is obtained, an open curve being defined as having an angle between the direction of the longitudinal axis of the proximal portion of the inner sheath where it joins the precurved portion and the direction of the longitudinal axis at a distal end of the precurved portion of the inner sheath of more than 90°

.

37. The method of claim 35 wherein providing an inner sheath with a prebiased curvature provides the inner sheath with a longitudinal axis and so that the single radius of curvature and relative length of the distal precurved portion are form a closed curve, a closed curve being defined as having an angle between the direction of the longitudinal axis of the proximal portion of the inner sheath where it joins the precurved portion and the direction of the longitudinal axis at a distal end of the precurved portion of the inner sheath of less than 90°

.

38. The method of claim 34 where providing an inner sheath with a prebiased curvature provides the precurved portion of the inner sheath with two curved subportions and a straight subportion therebetween of form a flattened hook.

39. The method of claim 38 where providing an inner sheath with two curved subportions comprises providing a proximal curved subportion having a radius of curvature of a first magnitude and a distal curved subportion having a radius of curvature of a second magnitude less than the first magnitude.

40. The method of claim 39 where providing the radius of curvature of the first magnitude provides a magnitude of approximately 1 inch and a radius of curvature of the second magnitude of approximately 0.2 to 0.3 inch.

41. The method of claim 26 further comprising longitudinally separating the outer sheath.

42. The method of claim 26 further comprising longitudinally separating the inner sheath.

43. The method of claim 26 further comprising longitudinally separating the inner and outer sheaths.

44. The method of claim 26 further providing a distal balloon.

45. The method of claim 26 further comprising communicating a proximal sidearm to the at least one longitudinal lumen defined in the inner sheath and to a hemostatic valve coupled to and terminating the sidearm.

46. A method for use in the coronary sinus venous system comprising:

disposing into the coronary sinus venous system a flexible, elongate, nontorqueable sheath having a longitudinal lumen defined therein; and

slidingly disposing an elongate, telescopic core into the lumen of the sheath, the core being structurally reinforced so that it is torsionally stiff while remaining radially flexible by virtue of a structural reinforcement in or on the core;

rotating a proximal end of the core; and

consequently rotating a distal end of the sheath by rotation of the core.

47. The method of claim 46 where slidingly disposing an elongate, telescopic core into the lumen of the sheath comprises slidingly disposing a core reinforced by a braid into the lumen.

51. The method of claim 46 where the core and sheath are both shaped with at least similar shapes and where consequently rotating a distal end of the sheath by rotation of the core comprises coupling the core and sheath at least in part by the interference fit between the shaped core and sheath.

52. The method of claim 46 where a first hub arises proximally connected to the sheath and a second hub is proximally connected to the core and where consequently rotating a distal end of the sheath by rotation of the core comprises coupling the first and second hub together and proximally rotating the first and second hubs.

53. The method of claim 46 where consequently rotating a distal end of the sheath by rotation of the core comprises frictionally engaging the lumen of the sheath with the core as the core is being rotated.