Reduced profile delivery sheath for use in interventional procedures

• US 6,679,902 B1
• Filed: 07/19/2000
• Issued: 01/20/2004
• Est. Priority Date: 07/19/2000
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Boyle, William J., Huter, Benjamin C., Denison, Andy E.
• Primary Examiner(s): Denion, Thomas
• Assistant Examiner(s): TRIEU, THAI BA
• Application Number:
  US09/619,001
• Time in Patent Office: 1,280 Days
• Field of Search: 604/264, 604/104-109, 604/103.1, 604/523, 604/529, 604/532, 604/536, 606/200
• US Class Current: 606/200
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 25/0068 Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 Tip not integral with tube
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

A delivery sheath is provided for deploying a self-expanding intravascular filter. The sheath includes a stiff proximal portion which provides for good pushability and trackability through tortuous vessels and a soft, flexible, low profile, radiopaque distal tip for holding and delivering a deployable filter. The soft distal tip minimizes the formation of embolic particles that may be produced by contact between the sheath and an arterial lesion. The distal tip may be molded from a polymer containing radiopaque particles held in suspension and thereby provides for good visualization under fluroscopy.

Claims

1. A sheath for delivering and deploying an intravascular filter device within a body lumen, comprising:

an elongated, tubular proximal portion adapted for deployment within a body lumen and a tubular distal tip extending from the proximal portion, wherein the outside diameter of the distal tip is less than the outside diameter of the proximal portion; and

the distal tip has a cavity sized for slidable receipt of an intravascular filter device.

2. The delivery sheath of claim 1, wherein:

the distal tip includes means for achieving radiopacity.

3. The delivery sheath of claim 1, wherein:

the means for achieving radiopacity comprises a plurality of radiopaque marker bands attached to the distal tip.

4. The delivery sheath of claim 2, wherein:

the means for achieving radiopacity comprises radiopaque particles in suspension within a polymer which forms the tip.

5. The delivery sheath of claim 4, wherein:

the radiopaque particles are bismuth particles.

6. The delivery sheath of claim 4, wherein:

the polymer is polyethylene.

7. The delivery sheath of claim 4, wherein:

the polymer is PeBax 40D.

8. The delivery of sheath of claim 1, wherein:

the distal tip is sufficiently long to fully enclose the intravascular filter.

9. The delivery sheath of claim 1, wherein:

distal portion is formed from a polymer material with a modulus of elasticity lower than that of the material which forms the proximal portion.

10. The delivery sheath of claim 9, wherein:

the proximal portion is formed from high density polyethylene and the distal is formed from low density polyethylene.

11. The delivery of sheath of claim 1, wherein:

the proximal portion and the distal tip are co-molded to form a single unitary sheath.

12. The delivery sheath of claim 1, wherein:

the proximal portion and the distal tip are formed as discrete components and are joined to form a unitary sheath.

13. The delivery sheath of claim 1, wherein:

the proximal portion has a thick wall with a relatively small lumen sized for receipt of a guidewire and wherein the distal portion has a comparatively thin wall and a comparatively large lumen for receipt of a filter device.

14. A sheath for delivering and deploying an intravascular filter within a body lumen, the sheath comprising:

an elongated proximal portion having proximal and distal ends and a lumen extending therebetween, the proximal portion being adapted for deployment in a body lumen; and

a distal tip connected to the proximal portion, wherein the outside diameter of the distal tip is less than the outside diameter of the proximal portion, the distal tip including a profiled cavity having a through-hole for communicating with the lumen of the proximal portion, wherein the profiled cavity is adapted to slidably receive and hold an intravascular filter in a half-load position.

15. The delivery sheath of claim 14, wherein:

the profiled cavity is cylindrical with a conical end portion.

16. The delivery sheath of claim 14, wherein:

the profiled cavity is cylindrical with a parabolic end portion.

17. The delivery of sheath claim 14, wherein:

the proximal portion and the distal tip are co-molded to form a single unitary sheath.

18. The delivery sheath of claim 14, wherein:

the distal tip includes means for achieving radiopacity.

19. The delivery sheath of claim 18, wherein:

the means for achieving radiopacity comprises a plurality of radiopaque marker bands attached to the distal tip.

20. The delivery sheath of claim 18, wherein:

the means for achieving radiopacity comprises radiopaque particles in suspension within a polymer which forms the tip.

21. The delivery sheath of claim 20, wherein:

the radiopaque particles are bismuth particles.

22. The delivery sheath of claim 20, wherein:

the radiopaque particles are barium oxide particles.

23. A delivery system for delivering an intravascular filter device within a body lumen, the system comprising:

an expandable filter device deployable within a vessel lumen;

a guide wire having proximal and distal ends, wherein the filter device is attached to the distal end of the guide wire;

a delivery sheath having an elongated tubular proximal portion and a tubular distal tip connected to the proximal portion, wherein the outside diameter of the distal tip is less than the outside diameter of the proximal portion and the proximal portion and distal tip are adapted for deployment within a body lumen;

the distal tip including a cavity having a hole for communication with the lumen of the proximal portion, the cavity being adapted for slidable receipt of an intravascular filter;

the distal tip further including radiopaque means for achieving radiopacity, wherein the tip is visible during fluoroscopy;

means for positively locating the filter within the profiled cavity; and

the proximal end of the guide wire being threaded through the distal tip of the delivery sheath, wherein the filter is seated within the profiled cavity.

24. The delivery system of claim 23, wherein:

the radiopaque means comprises barium particles held in suspension within the polymer which forms the tip.

25. The delivery system of claim 24, wherein:

the radiopaque means comprises a plurality of radiopaque markers attached to the tip.

26. The delivery system of claim 23, wherein:

the means for positively locating the filter within the profiled cavity includes a radiopaque marker affixed to the guide wire proximal of the filter and a bearing surface withing the profiled cavity, wherein the radiopaque marker abuts the bearing surface when the guide wire is fully threaded through the delivery sheath.

27. The delivery system of claim 23, wherein:

the profiled cavity is adapted to slidably receive and hold an intravascular filter in a half-load position.

28. The delivery system of claim 23, further including:

an obturator which provides a smooth transition from the tip to the filter device.