Inner and outer telescoping catheter delivery system and method

• US 8,401,673 B2
• Filed: 04/07/2010
• Issued: 03/19/2013
• Est. Priority Date: 01/28/2002
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Bowe, Wade A., Johnson, Eric T.
• Primary Examiner(s): STIGELL, THEODORE J
• Application Number:
  US12/755,924
• Publication Number:
  US 20100191315A1
• Time in Patent Office: 1,077 Days
• Field of Search: 604/95.04, 604/158, 604/528, 604/532, 606/32, 606/41, 606/194, 607/122, 600/585
• US Class Current: 607/122
• 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 method of delivering a payload to a destination vessel branching from a coronary sinus of a patient'"'"'s heart. The method comprises inserting a catheter assembly into a right atrium of the patient'"'"'s heart. The catheter assembly comprises an outer catheter and an inner catheter movably disposed within the open lumen of the outer catheter. The inner and outer catheters are operable to be rotated and translated relative to one another such that the distal end of the outer catheter can assume a selectable plurality of shapes appropriate for accessing the coronary sinus. The method further comprises locating and cannulating the patient'"'"'s coronary sinus by adjusting a relative orientation or longitudinal position of the inner catheter relative to the outer catheter, longitudinally sliding the outer catheter over the distal end of the inner catheter to deep seat the outer catheter within the patient'"'"'s coronary sinus, and delivering a payload to the destination vessel through the outer catheter or the inner catheter.

Claims

1. A method of delivering a payload to a destination vessel branching from a coronary sinus of a patient'"'"'s heart, comprising:

inserting a catheter assembly into a right atrium of the patient'"'"'s heart, the catheter assembly comprising;

an outer catheter having an open lumen and a pre-formed distal end defined by 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 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 extendable beyond the preformed distal end of the outer catheter, the inner and outer catheters operable to be axially rotated and longitudinally translated relative to one another such that the distal end of the outer catheter can assume a selectable plurality of multi-dimensional shapes appropriate for accessing the coronary sinus;

locating and cannulating the patient'"'"'s coronary sinus by adjusting a relative orientation or longitudinal position of the inner catheter relative to the outer catheter 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;

longitudinally sliding the outer catheter over the distal end of the 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

delivering a payload to the destination vessel through the outer catheter.

2. The method of claim 1 further comprising removing the outer catheter from the patient'"'"'s vasculature while leaving the payload in the destination vessel.

3. The method of claim 1 wherein the payload is a pacing electrode on a pacing lead.

4. The method of claim 1 wherein the catheter assembly further comprises a steering mechanism disposed within the 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 where in 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.

5. The method of claim 1 further comprising inserting a guide wire through a patient'"'"'s right atrium via an access vessel, and wherein inserting the catheter assembly further comprises inserting the catheter assembly over the guide wire through the patient'"'"'s right atrium via an access vessel.

6. The method of claim 1 further comprising injecting a contrast media through the inner catheter for mapping blood vessels after locating and cannulating the patient'"'"'s coronary sinus.

7. The method of claim 1 wherein the pre-formed distal end of the inner catheter includes 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.

8. The method of 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.

9. The method of 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.

10. The method of 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 method of delivering a payload to a destination vessel branching from a coronary sinus of a patient'"'"'s heart, comprising:

inserting a catheter assembly into a right atrium of the patient'"'"'s heart, the catheter assembly comprising;

an outer catheter having an open lumen and a pre-formed distal end defined by 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 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 extendable beyond the preformed distal end of the outer catheter;

the inner and outer catheters operable to be rotated and translated relative to one another such that the distal end of the outer catheter can assume a selectable plurality of multi-dimensional shapes appropriate for accessing the coronary sinus;

locating and cannulating the patient'"'"'s coronary sinus by adjusting a relative orientation or longitudinal position of the inner catheter relative to the outer catheter such that one of both of a bend radius and a bend angle of the pre-formed distal end of the outer catheter is modified;

longitudinally advancing the inner catheter within the outer catheter to a location within or proximate the destination vessel;

inserting a payload through the inner catheter to a position within the destination vessel; and

longitudinally sliding the inner catheter and the outer catheter over the payload to remove the inner and outer catheters from the patient while leaving the payload positioned in the destination vessel.

12. The method of claim 11 wherein the payload is a pacing electrode on a pacing lead.

13. The method of claim 11 further comprising inserting a guide wire through a patient'"'"'s right atrium via an access vessel, and wherein inserting the catheter assembly further comprises inserting the catheter assembly over the guide wire through the patient'"'"'s right atrium via an access vessel.

14. The method of claim 11 further comprising injecting a contrast media through the inner catheter for mapping blood vessels after locating and cannulating the patient'"'"'s coronary sinus.

15. The method of claim 11 wherein the pre-formed distal end of the inner catheter includes 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.

16. The method of claim 11 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.

17. The method of claim 11 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.

18. The method of claim 17 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.

19. A method of delivering a payload to a destination vessel branching from a coronary sinus of a patient'"'"'s heart, comprising:

inserting a catheter assembly into a right atrium of the patient'"'"'s heart, the catheter assembly, comprising;

an outer catheter having an open lumen and a pre-formed distal end defined by 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 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 extendable beyond the preformed distal end of the outer catheter;

selectively altering a shape of the catheter assembly by adjusting a relative orientation or longitudinal position of the inner catheter relative to the outer catheter 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, in order to locate and cannulate the patient'"'"'s coronary sinus;

longitudinally advancing the inner catheter to a location within or proximate the destination vessel;

inserting a payload through the inner catheter to a position within the destination vessel; and

longitudinally sliding the inner catheter and the outer catheter to remove the inner and outer catheters from the patient while leaving the payload positioned in the destination vessel.

20. The method of claim 19 wherein inserting the payload through the inner catheter includes inserting a pacing lead through the inner catheter.