Telescoping guide catheter with peel-away outer sheath

• US 8,126,570 B2
• Filed: 04/13/2010
• Issued: 02/28/2012
• Est. Priority Date: 12/31/2001
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Manning, Frank E., Peterson, Charles R., Graham, Howard P.
• Primary Examiner(s): Manuel, George
• Application Number:
  US12/759,379
• Publication Number:
  US 20100198194A1
• Time in Patent Office: 686 Days
• Field of Search: 607/119
• US Class Current: 607/119
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

A guide catheter includes an outer guide having an open lumen and a longitudinal pre-stress line extending between a distal end and a proximal end of the outer guide. The outer guide has a longitudinal stiffness that facilitates transmission of forces and prevention of kinking during steering of the outer guide within cardiac vasculature and structures. An inner guide has an open lumen and is movably displaceable within the open lumen of the outer guide. At least a distal end of the outer guide and inner guide are dimensioned for passage into the patient'"'"'s coronary sinus. A guide handle is connected to the proximal end of the outer guide and includes a longitudinal pre-stress line separable into at least two sections such that guide handle separation splits the outer guide along the longitudinal pre-stress line at the proximal end of the outer guide.

Claims

1. A guide catheter having proximal and distal ends, comprising:

an outer guide having an open lumen and a longitudinal pre-stress line extending between a distal end and a proximal end of the outer guide, at least the distal end of the outer guide dimensioned for passage into a patient'"'"'s coronary sinus and having either varying stiffness or a pre-formed bend at a deflection location;

an inner guide having an open lumen and a compliancy greater than that of the outer guide, the inner guide movably displaceable within the open lumen of the outer guide such that the inner guide can rotate axially and translate longitudinally relative to the outer guide, at least a distal end of the inner guide having a pre-formed curve and dimensioned for passage into the patient'"'"'s coronary sinus;

a guide handle comprising a steering mechanism and having a distal end connected to the proximal end of the outer guide, the guide handle separable into at least two sections such that guide handle separation splits the outer guide along the longitudinal pre-stress line at the proximal end of the outer guide, the outer guide further splitting along the longitudinal pre-stress line upon outer guide retraction in a proximal direction relative to the inner guide;

a steering tendon anchored at a distal tip of the outer guide, extending along the outer guide, and coupled to the steering mechanism; and

a guide tip defined by a distal tip of the inner guide when extended beyond the distal tip of the outer guide, the guide tip modifiable in terms of tip angle, tip shape, and tip length in response to changes in steering tendon tension and relative axial and longitudinal movement between the distal end of the inner guide and the distal end of the outer guide having the varying stiffness.

2. The catheter of claim 1, wherein the inner guide has a longitudinal stiffness that facilitates maintaining of inner guide position when the outer guide is retracted in a proximal direction relative to the inner guide.

3. The catheter of claim 1, wherein the pre-formed curve of the inner guide is located about 1 centimeter to about 10 centimeters from the distal tip of the inner guide and comprises a bend angle ranging from about 20 degrees to about 100 degrees.

4. The catheter of claim 1, wherein the inner guide comprises a lubricious lining along its inner surface.

5. The catheter of claim 1, further comprising an occlusion balloon provided at the distal end of the inner guide.

6. The catheter of claim 1, further comprising an occlusion balloon provided at the distal end of the outer guide.

7. The catheter of claim 1, further comprising mapping electrodes provided at the distal end of the inner guide.

8. The catheter of claim 1, further comprising mapping electrodes provided at the distal end of the outer guide.

9. The catheter of claim 1, wherein the steering mechanism is supported by one of the at least two sections of the guide handle.

10. The catheter of claim 1, wherein the steering mechanism comprises a pivotally mounted steering handle.

11. The catheter of claim 1, wherein the inner guide is configured to receive a pacing lead having an outer diameter smaller than an inner diameter of the inner guide.

12. The catheter of claim 1, wherein the outer guide, after removal of the inner guide from the outer guide, is configured to receive a pacing lead having an outer diameter smaller than an inner diameter of the outer guide.

13. A guide catheter having proximal and distal ends, comprising:

an outer guide having an open lumen and two opposing longitudinal pre-stress lines extending between a distal end and a proximal end of the outer guide, at least the distal end of the outer guide dimensioned for passage into a patient'"'"'s coronary sinus and having either varying stiffness or a pre-formed bend at a deflection location;

an inner guide having an open lumen and a compliancy greater than that of the outer guide, the inner guide movably displaceable within the open lumen of the outer guide such that the inner guide can rotate axially and translate longitudinally relative to the outer guide, at least a distal end of the inner guide having a pre-formed curve and dimensioned for passage into the patient'"'"'s coronary sinus;

a guide handle comprising a steering mechanism, two opposing handle members, a channel defined within the guide handle between the two handle members, and a distal end connected to the proximal end of the outer guide, the guide handle comprising two opposing seams along which the guide handle is separable into at least two sections, each of the two sections including a respective one of the two handle members, the two opposing seams of the guide handle aligned longitudinally with the two opposing longitudinal pre-stress lines of the outer guide, the two handle members extending proximally of the outer guide'"'"'s proximal end and positioned such that relative movement between the two handle members concentrates leverage assisted force at the proximal end of the outer guide to split the outer guide along the two opposing longitudinal pre-stress lines, the channel dimensioned to allow passage of the distal end of the inner catheter through the channel and into the open lumen of the outer guide such that the inner guide is longitudinally displaceable and axially rotatable within, and relative to, the guide handle;

a steering tendon anchored at a distal tip of the outer guide, extending along the outer guide, and coupled to the steering mechanism; and

a guide tip defined by a distal tip of the inner guide when extended beyond the distal tip of the outer guide, the guide tip modifiable in terms of tip angle, tip shape, and tip length in response to changes in steering tendon tension and relative axial and longitudinal movement between the distal end of the inner guide and the distal end of the outer guide having the varying stiffness.

14. The catheter of claim 13, wherein the steering tendon is situated along the outer guide positioned 90 degrees relative to the two opposing pre-stress lines of the outer guide.

15. The catheter of claim 13, wherein the steering mechanism comprises a pivotally mounted steering handle.

16. The catheter of claim 13, wherein the inner guide has a longitudinal stiffness that facilitates maintaining of inner guide position when the outer guide is retracted in a proximal direction relative to the inner guide.

17. The catheter of claim 13, wherein the pre-formed curve of the inner guide is located about 1 centimeter to about 10 centimeters from the distal tip of the inner guide and comprises a bend angle ranging from about 20 degrees to about 100 degrees.

18. The catheter of claim 13, further comprising an occlusion balloon provided at the distal end of one or both of the inner guide and the outer guide.

19. The catheter of claim 13, further comprising mapping electrodes provided at the distal end of one or both of the inner guide and the outer guide.

20. A method, comprising:

advancing a guide catheter to a location in a patient'"'"'s right atrium proximate an ostium of the patient'"'"'s coronary sinus, the catheter comprising;

an outer guide having an open lumen and a longitudinal pre-stress line extending between a distal end and a proximal end of the outer guide, at least the distal end of the outer guide dimensioned for passage into the coronary sinus and having either varying stiffness or a pre-formed bend at a deflection location;

an inner guide having an open lumen and a compliancy greater than that of the outer guide, the inner guide movably displaceable within the open lumen of the outer guide such that the inner guide can rotate axially and translate longitudinally relative to the outer guide, at least a distal end of the inner guide having a pre-formed curve and dimensioned for passage into the coronary sinus;

a guide handle comprising a steering mechanism and having a distal end connected to the proximal end of the outer guide, the guide handle separable into at least two sections;

a steering tendon anchored at a distal tip of the outer guide, extending along the outer guide, and coupled to the steering mechanism; and

a guide tip defined by a distal tip of the inner guide when extended beyond the distal tip of the outer guide;

modifying the guide tip in terms of tip angle, tip shape, and tip length to locate and cannulate the coronary sinus by changing steering tendon tension and relative axial and longitudinal movement between the distal end of the inner guide and the distal end of the outer guide having the varying stiffness;

delivering a payload through the inner guide after cannulation of the coronary sinus; and

retracting the outer guide relative to the inner guide by splitting the guide handle and the outer guide along the longitudinal pre-stress line without dislodging the payload.