Telescopic introducer with a compound curvature for inducing alignment and method of using the same

• US 20040019359A1
• Filed: 07/24/2002
• Published: 01/29/2004
• Est. Priority Date: 07/24/2002
• 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 7,993,351 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• 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: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

An introducer system for implantation of pacemaker leads into the venous system of the human heart through the coronary sinus is comprised of a flexible, elongate, outer elongate element having a first shape or bias along a portion. The first shape on the outer element may be prebiased or may be initially straight and subsequently biased once deployed in the body chamber. A flexible, elongate, telescopic inner elongate element has a second shape or bias on its distal portion and has the first shape or bias on a more proximal portion. The inner elongate element is telescopically disposed in the outer sheath. The outer and inner elongate elements are rotatable with respect to each other, such that when the inner elongate element is distally extended from the outer sheath, there exists an angular orientation between the inner and outer sheaths which is congruent, when there is at least partial alignment between the distal portion of the outer elongate element and the more proximal portion of the inner sheath, both having the first shape or bias. This results in the rotation of the distal second shape or curve of the inner elongate element into a predetermined three dimensional location.

Claims

1. A telescopic introducer apparatus comprising:

an outer elongate element; and

an inner elongate element having a preferred relative orientation with respect to the outer elongate element, the inner elongate element being telescopically disposed in the outer elongate element, the outer and inner elements including means for orienting one with respect to the other, such that when the inner elongate element is distally extended from the outer element, there exists a preferred orientation between the inner and outer elements.

2. The introducer apparatus of claim 1 where:

the outer elongate element has a first shape or bias along a first-shape portion; and

the inner elongate element has a second shape or bias on its distal portion and has the first shape or bias on a more proximal first-shape portion, the outer and inner elements being relatively, angularly orientable with respect to each other, such that when the inner elongate element is distally extended from the outer element, the preferred angular orientation between the inner and outer elements is achieved, which angular orientation is congruent when there is at least partial alignment between the first-shape portion of the outer elongate element and the first-shape portion of the inner elongate element.

3. The telescopic introducer apparatus of claim 2 wherein the alignment between the first-shape portion of the outer elongate element and the more proximal first-shape portion of the inner elongate element comprises an alignment of a longitudinal shape or bias.

4. The telescopic introducer apparatus of claim 2 wherein the alignment between the first-shape portion of the outer elongate element and the more proximal first-shape portion of the inner elongate element comprises an alignment of a radial cross-sectional shape.

5. The telescopic introducer apparatus of claim 3 wherein the alignment between the first-shape portion of the outer elongate element and the more proximal first-shape portion of the inner elongate element also comprises an alignment of a radial cross-sectional shape.

6. The telescopic introducer apparatus of claim 2 further comprising means for rotating a distal end of the inner elongate element from a proximal end of the inner elongate element so that the inner elongate element is steerable.

7. The telescopic introducer apparatus of claim 6 where the means for rotating a distal end of the inner elongate element from a proximal end of the inner elongate element comprises a torsionally stiff core, and wherein the inner elongate element is torsionally flexible.

8. The telescopic introducer apparatus of claim 7 wherein the inner elongate element is unreinforced.

9. The telescopic introducer apparatus of claim 6 where the means for rotating a distal end of the inner elongate element from a proximal end of the inner elongate element comprises means for rendering the inner elongate element torsionally stiff.

10. The telescopic introducer apparatus of claim 9 where the means for rendering the inner elongate element torsionally stiff comprises braiding incorporated in or on the inner elongate element.

11. The telescopic introducer apparatus of claim 2 where the inner elongate element has at least one longitudinal lumen defined therethrough adapted for injection of a fluid.

12. The telescopic introducer apparatus of claim 2 where the inner elongate element has at least one longitudinal lumen defined therethrough adapted for disposition of a guide wire therethrough.

13. The telescopic introducer apparatus of claim 11 further comprising a proximal sidearm communicated to the at least one longitudinal lumen and a hemostatic valve coupled to and terminating the sidearm.

14. The telescopic introducer apparatus of claim 2 further comprising a distal radioopaque section or marker on the inner elongate element.

15. The telescopic introducer apparatus of claim 7 further comprising a distal radioopaque section or marker on the core.

16. The telescopic introducer apparatus of claim 2 where the inner elongate element comprises a proximal flexible unbiased portion and a distal precurved portion, which has a curvature for optimally steering the inner elongate element into the coronary sinus venous system of the heart.

17. The telescopic introducer apparatus of claim 16 wherein the distal precurved portion has a single radius of curvature and a distal most straight portion.

18. The telescopic introducer apparatus of claim 17 wherein the inner elongate element 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 elongate element where it joins the precurved portion and the direction of the longitudinal axis at a distal end of the precurved portion of the inner elongate element of more than 90°

.

19. The telescopic introducer apparatus of claim 17 wherein the inner elongate element 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 elongate element where it joins the precurved portion and the direction of the longitudinal axis at a distal end of the precurved portion of the inner elongate element of less than 90°

.

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

21. The telescopic introducer apparatus of claim 20 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.

22. The telescopic introducer apparatus of claim 21 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.

23. The telescopic introducer apparatus of claim 2 where the outer elongate element is longitudinally openable or separable.

24. The telescopic introducer apparatus of claim 2 where the inner elongate element is longitudinally openable or separable.

25. The telescopic introducer apparatus of claim 2 where the outer and inner elements are both longitudinally openable or separable.

26. The telescopic introducer apparatus of claim 2 further comprising a distal balloon.

27. The telescopic introducer apparatus of claim 2 further comprising a proximal sidearm communicated to the at least one longitudinal lumen and a hemostatic valve coupled to and terminating the sidearm.

28. The introducer apparatus of claim 1 where the means for orienting the outer elongate element with respect to the inner elongate element comprises a key defined on one the outer or inner elongate elements and a corresponding keyway defined in the other one of the outer or inner elongate elements.

29. The introducer apparatus of claim 1 where the means for orienting the outer elongate element with respect to the inner elongate element comprises a detent pin defined on one the outer or inner elongate elements and a corresponding detent cavity defined in the other one of the outer or inner elongate elements.

30. The introducer apparatus of claim 1 where the means for orienting the outer elongate element with respect to the inner elongate element comprises a follower pin defined on one the outer or inner elongate elements and a corresponding helical groove defined in the other one of the outer or inner elongate elements.

56. The introducer apparatus of claim 2 where the first-shape portion and the second-shape portion of the inner and outer elongate elements are compound curves.

57. The introducer apparatus of claim 2 where the first-shape portion and the second-shape portion of the inner and outer elongate elements are defined as elephant curves.

58. The introducer apparatus of claim 2 where the first-shape portion and the second-shape portion of the inner and outer elongate elements lie in a common plane, the first-shape portion comprising portions having its radii of curvature lying on one side of the elongate element and the second-shape portion comprising portions having its radii of curvature lying on an opposing side of the elongate element.

59. The introducer apparatus of claim 58 where the second-shape portion of the inner and outer elongate elements has a hockey stick curve.

60. The introducer apparatus of claim 58 where the second-shape portion of the inner and outer elongate elements has a multipurpose curve.

61. The introducer apparatus of claim 58 where the second-shape portion of the inner and outer elongate elements has a hook curve.

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

an outer elongate element having a longitudinal lumen defined therein and having a first shape or bias along a first-shape portion;

a nontorqueable inner elongate element having a longitudinal lumen defined therein and having a first shape or bias along a first-shape portion, and a second shape or bias along a second-shape portion, the inner elongate element being telescopically disposed within the outer elongate element; and

an elongate, telescopic core having the second shape or bias on its distal portion and having the first shape or bias on a more proximal portion, the core being telescopically disposed in the lumen of the inner elongate element, the core being structurally reinforced so that it is torsionally stiff while remaining radially flexible,

wherein the inner elongate element and the core in combination are relatively rotatable as a unit with respect to the outer elongate element, and when the inner elongate element along with the core are distally extended from the outer elongate element, there exists an angular orientation between the inner elongate element and core combination which is congruent with the first-shape portion of the outer elongate element.

32. The telescopic introducer system of claim 31 where the core is adapted to rotationally couple with an inner elongate element and when in a congruent match with the inner elongate element shape or curve, the distal end of the inner elongate element being rotated when a proximal end of the core is rotated.

33. The telescopic introducer of claim 31 where the core is reinforced by a braid.

34. A method for use of a telescopic introducer comprising:

disposing a flexible, outer elongate element having a portion with a first-shape curvature into a branched body system to achieve a predetermined position of an inner elongate element in the branched body system;

biasing a flexible, inner elongate element to match the first-shape curvature defined in the outer elongate element;

telescopically disposing the inner elongate element into the outer elongate element, the inner elongate element having a distal portion with a second-shape curvature;

distally extending the inner elongate element from the outer elongate element to allow the inner elongate element to assume the second-shape curvature in the branched body system; and

angularly orienting the outer and inner elongate elements with each other to congruently match the more proximal first-shape portion of the inner elongate element with the first-shape portion of the outer elongate element so that the distal second-shape portion of the inner elongate element assumes a predetermined three dimensional orientation in the branched body system.

35. The method of claim 34 further comprising rotating a distal end of the inner elongate element from a proximal end of the inner elongate element to steer the inner elongate element within the branched body system.

36. The method of claim 35 where rotating a distal end of the inner elongate element comprises rotating a torsionally stiff core disposed within a torsionally flexible the inner elongate element.

37. The method of claim 34 where the inner elongate element has at least one longitudinal lumen defined therethrough and further comprising injecting a fluid therethrough.

38. The method of claim 34 where the inner elongate element has at least one longitudinal lumen defined therethrough and further comprising disposing a guide wire through the lumen.

39. The method of claim 38 further comprising communicating a proximal sidearm to the at least one longitudinal lumen and to a hemostatic valve coupled to and terminating the sidearm.

40. The method of claim 34 further comprising providing a distal radioopaque section or marker on the inner elongate element.

41. The method of claim 36 further comprising providing a distal radioopaque section or marker on the core.

42. The method of claim 34 where distally extending the inner elongate element in the branched body system comprises providing an inner elongate element with a proximal-most flexible unbiased portion and wherein the second-shape curvature is chosen for optimally steering the inner elongate element into a coronary sinus venous system of a heart.

43. The method of claim 42 wherein providing an inner elongate element with a second-shape curvature provides the distal portion with a single radius of curvature and a distal most straight portion.

44. The method of claim 43 wherein providing an inner elongate element with a second-shape curvature provides the inner elongate element 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 elongate element where it joins the precurved portion and the direction of the longitudinal axis at a distal end of the precurved portion of the inner elongate element of more than 90°

.

45. The method of claim 43 wherein providing an inner elongate element with a second-shape curvature provides the inner elongate element 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 elongate element where it joins the precurved portion and the direction of the longitudinal axis at a distal end of the precurved portion of the inner elongate element of less than 90°

.

46. The method of claim 42 where providing an inner elongate element with a second-shape curvature provides the precurved portion of the inner elongate element with two curved subportions and a straight subportion therebetween of form a flattened hook.

47. The method of claim 46 where providing an inner elongate element 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.

48. The method of claim 47 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.

49. The method of claim 34 further comprising longitudinally separating the outer elongate element.

50. The method of claim 34 further comprising longitudinally separating the inner elongate element.

51. The method of claim 34 further comprising longitudinally separating the inner and outer elongate elements.

52. The method of claim 34 further providing a distal balloon.

53. The method of claim 34 further comprising communicating a proximal sidearm to the at least one longitudinal lumen defined in the inner elongate element and to a hemostatic valve coupled to and terminating the sidearm.

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

disposing into the cardiac venous system a flexible, nontorquable elongate element having a longitudinal lumen defined therein and having a distal portion with a second-shape curvature and a more proximal first-shape curvature;

curving a core to match the first-shape curvature defined in the elongate element;

telescopically disposing the core into the lumen of the elongate element, 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 having a distal portion with a second-shape curvature and a more proximal first-shape curvature;

rotating a proximal end of the core;

consequently rotating the elongate element by rotation of the core,

distally extending the core from the elongate element to allow the core to assume the second-shape curvature;

angularly orienting the core and elongate element with each other to congruently match a more proximal portion of the core having the first-shape curvature with the portion of the elongate element having the first-shape curvature so that the distal end of the core assumes a predetermined three dimensional orientation in the coronary sinus venous system.

55. The method of claim 54 where telescopically disposing an elongate, telescopic core into the lumen of the elongate element comprises slidingly disposing a core reinforced by a braid into the lumen.