Claims
- 1. A slittable delivery sheath sized for seating in the coronary sinus or a branch vein thereof, comprising:
a slittable hub; and a substantially-straight body defining an inner lumen, the body comprising:
a shaft section and a distal section that is distal to the shaft section, the shaft section being formed of a material that is harder than the distal section; and a slittable braid extending adjacent to at least a portion of one of the shaft section and the distal section.
- 2. The sheath of claim 1, wherein the braid is formed of stainless steel.
- 3. The sheath of claim 2, wherein the braid has an ultimate tensile strength of between approximately 200 and 250 kilo-pounds per square inch (ksi).
- 4. The sheath of claim 3, wherein the braid has a pic count of between 35 and 55 pics per inch.
- 5. The sheath of claim 4, wherein the braid is formed of a wire having a diameter of approximately 0.002 inches.
- 6. The sheath of claim 5, wherein the wire is type-304 vacuum melt stainless steel wire.
- 7. The sheath of claim 1, and further comprising an internal liner adjacent at least a portion of the inner lumen.
- 8. The sheath of claim 7, wherein the internal liner is formed of a lubricious material.
- 9. The sheath of claim 8, wherein the lubricious material is selected from the group consisting of PolyTetraFluoroEthylene (PTFE), PolyVinylDieneFluoride (PVDF), and High-Density PolyEthylene (HDPE).
- 10. The sheath of claim 1, wherein the inner lumen has an inner diameter ranging from about 0.86 to 0.106 inches.
- 11. The sheath of claim 10, wherein the inner diameter is approximately 0.096 inches.
- 12. The sheath of claim 1, wherein the shaft section and the distal tip section are formed of a polymer tubing.
- 13. The sheath of claim 12, wherein the shaft section is formed of PEBAX tubing having a hardness ranging from approximately 55D to 72D (Shore).
- 14. The sheath of claim 13, wherein the shaft section has a length ranging from approximately 43 to 62 cm.
- 15. The sheath of claim 14, wherein the distal section is formed of PEBAX tubing having a hardness ranging from approximately 25D to 35D (Shore).
- 16. The sheath of claim 15, wherein the distal section has a length ranging from approximately 1.5 to 3.5 cm.
- 17. The sheath of claim 16, wherein the distal section includes a flourovisible marker band.
- 18. The sheath of claim 16, and further including a transition section that is distal to shaft section and proximal to distal section, the transition section being softer than the shaft section and harder than the distal section.
- 19. The sheath of claim 18, wherein transition section is formed of PEBX tubing having a hardness ranging from approximately 35D to 40D (Shore).
- 20. The sheath of claim 19, wherein transition section has a length ranging from about 2.25 and 5.5 cm.
- 21. The sheath of claim 20, wherein at least one of the shaft section, the transition section, and the distal section includes a radiopaque filler material.
- 22. The sheath of claim 20, wherein the shaft section further includes:
a proximal shaft segment; an intermediate shaft segment that is distal to, and softer than, the proximal shaft segment; and a distal shaft segment that is distal to, and softer than, the intermediate shaft segment.
- 23. The sheath of claim 22, wherein the proximal shaft segment is formed of PEBAX having a hardness ranging from approximately 70D to 72D (Shore), the intermediate shaft segment is formed of PEBAX having a hardness ranging from approximately 63D to 70D, and the distal shaft segment is formed of PEBAX having a hardness ranging from approximately 55D to 63D.
- 24. The sheath of claim 23, wherein the distal section further includes:
a soft distal segment; an intermediate distal segment distal to, and harder than, the soft distal segment; and a soft tip that is distal to, and softer than, the intermediate distal segment.
- 25. The sheath of claim 24, wherein the soft distal segment is formed of PEBAX having a hardness ranging from approximately 25D to 35D (Shore), the intermediate distal segment is formed of PEBAX having a hardness ranging from approximately 35D to 72D, and the soft tip is formed of PEBAX having a hardness ranging from approximately 25D to 35D.
- 26. The sheath of claim 25, wherein braid terminates at a location within intermediate distal segment.
- 27. The sheath of claim 23, wherein the transition section further includes:
a proximal transition segment; and a distal transition segment that is distal to, and softer than, the proximal transition segment.
- 28. The sheath of claim 27, wherein the proximal transition segment is formed of PEBAX having a hardness of approximately 40D, and the distal transition segment is formed of BEBAX having a hardness of approximately 35D.
- 29. A system for positioning implantable medical devices within the coronary sinus or a branch vein thereof, comprising:
a substantially straight slittable sheath having an inner lumen, a shaft section, and a distal section that is distal to, and softer than, the shaft section, the sheath further including a slittable braid adjacent to at least a portion of at least one of the shaft section and the distal section; and a steerable catheter having a shaft adapted to be inserted within the inner lumen of the sheath.
- 30. The system of claim 20, wherein the steerable catheter is an EP catheter.
- 31. The system of claim 30, wherein the braid is formed of stainless steel.
- 32. The system of claim 31, wherein the braid has an ultimate tensile strength of between approximately 200 and 250 kilo-pounds per square inch (ksi).
- 33. The system of claim 32, wherein the braid has a pic count of between 35 and 55 pics per inch.
- 34. The system of claim 33, wherein the braid is formed of a wire having a diameter of approximately 0.002 inches.
- 35. The system of claim 34, wherein the wire is type-304 vacuum melt stainless steel wire.
- 36. The system of claim 35, and further comprising an internal liner adjacent at least a portion of the inner lumen.
- 37. The system of claim 36, wherein the internal liner is formed of a lubricious material.
- 38. The system of claim 37, wherein the lubricious material is selected from the group consisting of PolyTetraFluoroEthylene (PTFE), PolyVinylDieneFluoride (PVDF), and High-Density PolyEthylene (HDPE).
- 39. The system of claim 29, wherein the inner lumen has an inner diameter ranging from about 0.86 to 0.106 inches.
- 40. The system of claim 39, wherein the inner diameter is approximately 0.096 inches.
- 41. The system of claim 40, wherein the shaft of the steerable catheter has an outer diameter of less than 0.093 inches.
- 42. The system of claim 41, wherein the shaft section and the distal tip section are formed of a polymer tubing.
- 43. The system of claim 42, wherein the shaft section is formed of PEBAX tubing having a hardness ranging from approximately 55D to 72D (Shore).
- 44. The system of claim 43, wherein the shaft section has a length ranging from approximately 43 to 62 cm.
- 45. The system of claim 44, wherein the distal section is formed of PEBAX tubing having a hardness ranging from approximately 25D to 35D (Shore).
- 46. The system of claim 45, wherein the distal section has a length ranging from approximately 1.5 to 3.5 cm.
- 47. The system of claim 46, wherein the distal section includes a flourovisible marker band.
- 48. The system of claim 46, and further including a transition section that is distal to shaft section and proximal to distal section, the transition section being softer than the shaft section and harder than the distal section.
- 49. The system of claim 48, wherein transition section is formed of PEBX tubing having a hardness ranging from approximately 35D to 40D (Shore).
- 50. The system of claim 49, wherein transition section has a length ranging from about 2.25 and 5.5 cm.
- 51. The system of claim 50, wherein at least one of the shaft section, the transition section, and the distal section includes a radiopaque filler material.
- 52. The system of claim 50, wherein the shaft section further includes:
a proximal shaft segment; an intermediate shaft segment that is distal to, and softer than, the proximal shaft segment; and a distal shaft segment that is distal to, and softer than, the intermediate shaft segment.
- 53. The system of claim 52, wherein the distal section further includes:
a soft distal segment; an intermediate distal segment distal to, and harder than, the soft distal segment; and a soft tip that is distal to, and softer than, the intermediate distal segment.
- 54. A method for seating implantable medical devices within the coronary sinus or branch veins, comprising:
a.) providing a slittable sheath having a substantially-straight body defining an inner lumen, wherein the body of the sheath comprises:
a shaft section and a distal section that is distal to the shaft section, the shaft section being formed of a material that is harder than the distal section; and a slittable braid extending adjacent to at least a portion of one of the shaft section and the distal section; b.) inserting a steerable catheter within the inner lumen of the sheath; c.) positioning the steerable catheter and sheath within a body; and d.) navigating the steerable catheter and the sheath into the coronary sinus.
- 55. The method of claim 54, wherein step d.) comprises:
advancing a distal end of the steerable catheter beyond a distal end of the sheath; cannulating the coronary sinus with the steerable catheter; and advancing the distal tip of the sheath over the distal end of the steerable catheter and into the coronary sinus.
- 56. The method of claim 55, and further comprising:
withdrawing the steerable catheter from the body; advancing a balloon catheter within the inner lumen; obtaining a venogram; and withdrawing the balloon catheter from the body.
- 57. The method of claim 55, and further comprising advancing an implantable medical device (IMD) within the inner lumen of the sheath.
- 58. The method of claim 57, wherein the IMD is a lead.
- 59. The method of claim 58, wherein the lead has a lumen, and further including loading the lumen of the lead with a navigational device prior to advancing the lead within the inner lumen of the sheath.
- 60. The method of claim 58, wherein the advancing step includes:
advancing a navigational device within the inner lumen of the sheath; and advancing the lead over the navigational device.
- 61. The method of claim 59 or 60, wherein the navigational device is selected from the group consisting of a stylet, a guidewire, and a micro-deflection mechanism.
- 62. The method of claim 61, and further including sub-selecting a branch vein of the coronary sinus.
- 63. The method of claim 62, wherein the lead and navigational device are used to sub-select the branch vein.
- 64. The method of claim 62, and further including:
sub-selecting the branch vein with the sheath; and advancing the lead beyond the distal tip of the sheath.
- 65. The method of claim 64, and further including withdrawing the sheath and the navigational device from the body.
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of commonly-assigned U.S. patent application Ser. No. 09/822,678 filed Mar. 30, 2001, which is related to, and claims the benefit of, provisionally-filed U.S. patent application Ser. No. 60/193,695 filed Mar. 31, 2000, entitled “Intraluminal Visualization System with Deflectable Mechanism”.
[0002] Cross-reference is hereby made to commonly assigned related U.S. Applications, filed concurrently herewith, docket number P-10017.03 CIP2, entitled “METHOD AND SYSTEM FOR DELIVERY OF A MEDICAL ELECTRICAL LEAD WITHIN A VENOUS SYSTEM”, and docket number P-10017.04 CIP3, entitled “METHOD AND SYSTEM FOR DELIVERING A MEDICAL ELECTRICAL LEAD WITHIN A VENOUS SYSTEM”.
Provisional Applications (1)
|
Number |
Date |
Country |
|
60193695 |
Mar 2000 |
US |
Continuation in Parts (1)
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Number |
Date |
Country |
Parent |
09822678 |
Mar 2001 |
US |
Child |
10131436 |
Apr 2002 |
US |