Inner and outer telescoping catheter delivery system

• US 7,717,899 B2
• Filed: 01/28/2002
• Issued: 05/18/2010
• Est. Priority Date: 01/28/2002
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bowe, Wade A., Johnson, Eric
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Stigell; Theodore J
• Application Number:
  US10/059,809
• Publication Number:
  US 20030144657A1
• Time in Patent Office: 3,032 Days
• Field of Search: 604/95.01, 604/95.04, 604/158, 604/159, 604/161, 604/530, 604/532, 604523-528, 604/164.01, 604/164.03, 600/585, 606/41
• US Class Current: 604/525
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 25/0026 Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• 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 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0144 having flexible regions as a result of inner reinforcement means, e.g. struts or rods
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes

Abstract

A catheter assembly employs an outer catheter with a pre-formed distal end and an open lumen. An inner catheter having an open lumen and a pre-formed distal end is movably disposed within the outer catheter. Relative rotation and extension of the inner and outer catheters provides the distal end of the catheter assembly with an adjustable range of two- and three-dimensional shapes. The inner catheter can include sections of varying stiffness, such that extension of the inner catheter within the outer catheter modifies the shape of the outer catheter'"'"'s pre-formed distal end. The adjustable shaping of the catheter assembly'"'"'s distal tip provides an improved system for locating and cannulating cardiac venous structures, particularly the coronary sinus via the right atrium.

Claims

1. A catheter assembly for cannulating the coronary sinus of a patient'"'"'s heart from the right atrium, comprising:

an outer catheter comprising an open lumen and a pre-formed distal end having a plurality of curved sections and a generally straight distal tip section, all of the curved sections in the pre-formed distal end being oriented so as to assume the same general direction of curvature, the generally straight distal tip section extending from a distal-most curved section in a direction defined by the curvature of the distal-most curved section;

an inner catheter comprising an open lumen and a pre-formed distal end having an open distal tip, the pre-formed distal end including at least two adjacent longitudinal sections of varying stiffness and a stiffness transition region between the at least two adjacent longitudinal sections of varying stiffness, at least a portion of the inner catheter including a braid covered by an exterior jacket, the inner catheter movably disposed within the open lumen of the outer catheter, the pre-formed distal end of the inner catheter being more flexible than the pre-formed distal end of the outer catheter, and the pre-formed distal end of the inner catheter extendable beyond the preformed distal end of the outer catheter; and

a proximal mechanism for axially rotating the outer catheter relative to the inner catheter and longitudinally translating the inner catheter relative to the outer catheter, an orientation of the pre-formed distal end of the outer catheter relative to the pre-formed distal end of the inner catheter modified by relative axial rotation and relative longitudinal translation between the outer and inner catheters such that one or both of a bend radius and a bend angle of the pre-formed distal end of the outer catheter is modified and a distal end of the catheter assembly can assume a selectable plurality of multidimensional shapes appropriate for accessing the coronary sinus.

2. A catheter assembly according to claim 1, wherein the pre-formed distal end of the outer catheter further comprises:

at least two adjacent longitudinal sections of varying stiffness; and

at stiffness transition region between the at least two adjacent longitudinal sections of varying stiffness.

3. A catheter assembly according to claim 1, wherein the pre-formed distal end of the inner catheter includes a taper.

4. A catheter assembly according to claim 1, wherein the inner catheter is disposed within the open lumen of the outer catheter such that the distal end of the inner catheter protrudes from about 3 cm to about 15 cm from a distal tip of the outer catheter.

5. A catheter assembly according to claim 1, wherein the pre-formed distal end of the inner catheter further comprises one or more substantially straight sections adjacent one or more curved sections.

6. A catheter assembly according to claim 1, wherein the pre-formed distal end of the inner catheter further comprises at least one bend with a bend radius ranging from about 0.5 cm to about 5.0 cm and a bend angle ranging from about 0 degrees to about 180 degrees.

7. A catheter assembly according to claim 1, wherein the pre-formed distal end of the outer catheter further comprises one or more substantially straight sections adjacent one or more of the plurality of curved sections.

8. A catheter assembly according to claim 1, wherein:

the generally straight distal tip section of the outer catheter has a length of about 0 cm to about 6 cm; and

the pre-formed distal end of the outer catheter comprises;

a first curve proximally adjacent to the distal tip section having a bend radius of about 1 cm to about 5 cm and a bend angle of about 0 degrees to about 80 degrees;

a second straight section proximally adjacent to the first curve having a length of about 0 cm to about 6 cm; and

a second curve proximally adjacent to the second straight section having a bend radius of about 1 cm to about 5 cm and a bend angle of about 0 degrees to about 100 degrees.

9. A catheter assembly according to claim 8, wherein the pre-formed distal end of the outer catheter further comprises:

a third straight section proximally adjacent to the second curve having a length of about 0 cm to about 6 cm; and

a third curve proximally adjacent to the third straight section having a bend radius of about 1 cm to about 5 cm and a bend angle of about 0 degrees to about 125 degrees.

10. A catheter assembly according to claim 1, further comprising a steering mechanism disposed within an open lumen of the inner catheter, the steering mechanism comprising a guide member and a pull wire, the guide member and the pull wire extendable beyond the pre-formed distal end of the inner catheter.

11. A catheter assembly according to claim 10, wherein a bend at a distal section of the guide member is developed upon application of a force to the pull wire.

12. A catheter assembly according to claim 10, wherein the distal end of the catheter assembly assumes a plurality of two- and three-dimensional shapes in response to axial rotation and longitudinal transition of the outer catheter relative to the inner catheter and application of force to the pull wire.

13. A catheter assembly according to claim 10, wherein the guide member comprises a guide wire.

14. A catheter assembly according to claim 10, wherein the guide member comprises a guide ribbon.

15. A catheter assembly according to claim 14, wherein the inner catheter further comprises longitudinal slots disposed along an open lumen of the inner catheter, the guide ribbon slidably disposed within the longitudinal slots of the inner catheter.

16. A catheter assembly according to claim 1, further comprising:

at least one electrode located on the distal end of at least one of the inner and outer catheters; and

an electrical conductor coupled to the at least one electrode, the conductor disposed within at least one of the inner and outer catheters.

17. A catheter assembly according to claim 1, further comprising an occlusion balloon connected to the distal end of the inner catheter.

18. A catheter assembly according to claim 17, wherein the pre-formed distal end of the outer catheter further comprises:

at least two adjacent longitudinal sections of varying stiffness; and

a stiffness transition region between the at least two adjacent longitudinal sections of varying stiffness.

19. A catheter assembly according to claim 1, further comprising an occlusion balloon connected to the distal end of the outer catheter.

20. A catheter assembly, comprising:

an outer catheter comprising an open lumen and a pre-formed distal end having a plurality of curved sections and a generally straight distal tip section, all of the curved sections in the pre-formed distal end being oriented so as to assume the same general direction of curvature, the generally straight distal tip section extending from a distal-most curved section in a direction defined by the curvature of the distal-most curved section;

an inner catheter having an open lumen, a pre-formed distal end having an open distal tip, at least two adjacent longitudinal sections of varying stiffness, and a stiffness transition region between the at least two adjacent longitudinal sections of varying stiffness, at least a portion of the inner catheter including a braid covered by an exterior jacket, the inner catheter movably disposed within the open lumen of the outer catheter, the pre-formed distal end of the inner catheter being more flexible than the pre-formed distal end of the outer catheter, and the pre-formed distal end of the inner catheter extendable beyond the preformed distal end of the outer catheter; and

a proximal mechanism for axially rotating the outer catheter relative to the inner catheter and longitudinally translating the inner catheter relative to the outer catheter, an orientation of the pre-formed distal end of the outer catheter relative to the pre-formed distal end of the inner catheter modified by relative axial rotation and relative longitudinal translation between the outer and inner catheters and a shape of the pre-formed distal end of the outer catheter changed by relative longitudinal translation between the outer and inner catheters thereby changing orientation of the sections of varying stiffness of the inner catheter relative to the pre-formed distal end of the outer catheter, such that a distal end of the catheter assembly can assume a selectable plurality of multidimensional shapes.

21. A catheter assembly according to claim 20, wherein the pre-formed distal end of the inner catheter is tapered.

22. A catheter assembly according to claim 20, wherein the stiffness transition region of the inner catheter is about 5 cm to about 20 cm from a distal tip of the inner catheter.

23. A catheter assembly according to claim 20, wherein the pre-formed distal end of the inner catheter comprises a bend having a bend radius ranging from about 0.5 cm to about 5.0 cm and a bend angle ranging from about 0 degrees to about 180 degrees.

24. A catheter assembly according to claim 20, wherein the pre-formed distal end of the outer catheter further comprises one or more substantially straight sections adjacent one or more of the plurality of curved sections.

25. A catheter assembly according to claim 20, wherein:

the generally straight distal tip section of the outer catheter has a length of about 0 cm to about 6 cm; and

the pre-formed distal end of the outer catheter comprises;

a first curve proximally adjacent to the distal tip section having a bend radius of about 1 cm to about 5 cm and a bend angle of about 0 degrees to about 80 degrees;

a second straight section proximally adjacent to the first curve having a length of about 0 cm to about 6 cm; and

a second curve proximally adjacent to the second straight section having a bend radius of about 1 cm to about 5 cm and a bend angle of about 0 degrees to about 100 degrees.

26. A catheter assembly according to claim 25, wherein the pre-formed distal end of the outer catheter further comprises:

a third straight section proximally adjacent to the second curve having a length of about 0 cm to about 6 cm; and

a third curve proximally adjacent to the third straight section having a bend radius of about 1 cm to about 5 cm and a bend angle of about 0 degrees to about 125 degrees.