Inner and outer telescoping catheter delivery system

• US 20030144657A1
• Filed: 01/28/2002
• Published: 07/31/2003
• 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: Johnson, Eric, Bowe, Wade A.
• Granted Patent: US 7,717,899 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• 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;

an inner catheter comprising a lumen and a pre-formed distal end, 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 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 inner 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.

3. 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.

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

5. 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.

6. 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.

7. 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.

8. 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 curved sections.

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

a first straight section at a distal tip of the outer catheter having a length of about 0 cm to about 6 cm;

a first curve proximally adjacent to the first straight 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;

10. A catheter assembly according to claim 9, 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.

11. 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.

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

13. A catheter assembly according to claim 11, 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.

14. A catheter assembly according to claim 11, wherein the guide member comprises a guide wire.

15. A catheter assembly according to claim 11, wherein the guide member comprises a guide ribbon.

16. A catheter assembly according to claim 15, 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.

17. 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.

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

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

21. A catheter assembly according to claim 18, 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.

20. A catheter assembly, comprising:

an outer catheter comprising an open lumen and a pre-formed distal end;

an inner catheter having a lumen, a pre-formed distal end, 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, 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.

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

23. 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.

24. 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.

25. 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 curved sections.

26. A catheter assembly according to claim 20, wherein the pre-formed distal end of the outer catheter comprises:

a first straight section at a distal tip of the outer catheter having a length of about 0 cm to about 6 cm;

a first curve proximally adjacent to the first straight 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.

27. A catheter assembly according to claim 26, 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.

28. A method of inserting a payload into a coronary sinus of a patient'"'"'s heart, comprising:

providing a catheter assembly, comprising;

an outer catheter having an open lumen and a pre-formed distal end;

an inner catheter comprising a lumen and a pre-formed distal end, 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 a distal end of the catheter assembly can assume a selectable plurality of multidimensional shapes appropriate for accessing the coronary sinus;

inserting the distal end of the catheter assembly through a patient'"'"'s right atrium via an access vessel;

axially rotating the outer catheter relative to the inner catheter and longitudinally displacing the inner catheter relative to the outer catheter to direct the distal end of the inner catheter for locating and cannulating the patient'"'"'s coronary sinus;

longitudinally sliding the outer catheter over the distal end of inner catheter to deep seat the outer catheter within the patient'"'"'s coronary sinus;

longitudinally sliding the inner catheter out of the proximal end of the catheter assembly to remove the inner catheter; and

inserting a payload through the proximal end of the outer catheter such that the payload is inserted into the patient'"'"'s coronary sinus.

29. A method according to claim 28, further comprising removing the catheter assembly by axially sliding the outer catheter over the payload.

30. A method according to claim 28, wherein the catheter assembly further comprises 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, and wherein locating and cannulating the patient'"'"'s coronary sinus further comprises applying a force to the pull wire to direct the distal end of the inner catheter into the patient'"'"'s coronary sinus.

31. A method according to claim 28, wherein the payload comprises a pacing lead.

32. A method according to claim 28, wherein the payload comprises an occlusion catheter.

33. A method according to claim 28, further comprising inserting a guide wire through a patient'"'"'s right atrium via an access vessel after providing a catheter assembly, and wherein inserting the distal end of the catheter assembly further comprises inserting the distal end of the catheter assembly over the guide wire through the patient'"'"'s right atrium via an access vessel.

34. A method according to claim 28, further comprising injecting a contrast media through the inner catheter for mapping blood vessels after locating and cannulating the patient'"'"'s coronary sinus.

35. A method of accessing a pulmonary vein of a patient'"'"'s heart, comprising:

providing a catheter assembly, comprising;

an outer catheter having an open lumen and a pre-formed distal end;

an inner catheter comprising a lumen and a pre-formed distal end, 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 a distal end of the catheter assembly can assume a selectable plurality of multidimensional shapes;

inserting the distal end of the catheter assembly through a patient'"'"'s right atrium via an access vessel;

inserting a transseptal needle through an interatrial septum of the patient'"'"'s heart from the right atrium to create a transseptal puncture into the left atrium;

axially rotating the outer catheter relative to the inner catheter and longitudinally displacing the inner catheter relative to the outer catheter to direct the distal end of the catheter assembly for locating and cannulating the transseptal puncture; and

inserting a payload through the proximal end of the outer catheter such that the payload is inserted into the pulmonary vein via the left atrium.

36. A method according to claim 35, wherein the catheter assembly further comprises 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, and wherein locating and cannulating the transseptal puncture further comprises applying a force to the pull wire to direct the distal end of the catheter assembly into the transseptal puncture.

37. A method according to claim 35, wherein the payload comprises an ablation catheter.

38. A method according to claim 35, wherein the payload comprises a mapping catheter.

39. A method according to claim 35, further comprising injecting a contrast media through the catheter assembly for mapping blood vessels after locating and cannulating the transseptal puncture.