System and method for accessing the coronary sinus to facilitate insertion of pacing leads

• US 20040147826A1
• Filed: 01/27/2003
• Published: 07/29/2004
• Est. Priority Date: 01/27/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Peterson, Eric D.
• Granted Patent: US 6,928,313 B2
• Time in Patent Office: Days
• US Class Current: 600/374
• CPC Class Codes: A61M 2025/0063 having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
• CPC Class Codes: A61M 2025/09141 made of shape memory alloys which take a particular shape at a certain temperature
• CPC Class Codes: A61M 25/09025 with sliding mandrils
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A guiding catheter system employs an outer jacket with one or more inflation lumens provided along the length of the jacket. The lumens are in fluid communication with one or more fluted balloons mounted at a distal end of the outer jacket. A torquable stylet is movably disposed within an open lumen of the outer jacket. A guidewire is movably disposed in an open lumen of the torquable stylet. The outer jacket can be provided with break-away features allowing the jacket to be peeled off of a pacing lead.

Claims

1. A guiding catheter system for accessing a patient'"'"'s heart, comprising:

an outer jacket, comprising;

an open guide lumen;

at least one inflation lumen provided along an exterior surface of the outer jacket; and

at least one segment of a distal balloon fixably mounted at a distal portion of the outer jacket, the distal balloon in fluid communication with the at least one inflation lumen; and

a stylet disposed within the guide lumen of the outer jacket and comprising a distal pre-formed bend, the stylet rotatable within the outer jacket along a longitudinal axis of the outer jacket, the distal pre-formed bend of the stylet dimensioned to deflect the outer jacket laterally of the longitudinal axis of the outer jacket upon rotation of the stylet.

2. The guiding catheter system of claim 1, wherein the outer jacket further comprises a peel away feature provided along a longitudinal length of the outer jacket.

3. The guiding catheter system of claim 2, wherein the peel away feature comprises an undercut between the at least one inflation lumen and the exterior surface of the outer jacket.

4. The guiding catheter system of claim 2, wherein the peel away feature comprises a thickened section at an interface between the at least one inflation lumen and the exterior surface of the outer jacket.

5. The guiding catheter system of claim 1, wherein the stylet comprises an open lumen, the guiding catheter system further comprising a guidewire movably disposed within the open lumen of the stylet.

6. The guiding catheter system of claim 5, wherein the guidewire comprises a loop at a distal tip of the guidewire.

7. The guiding catheter system of claim 5, wherein the guidewire is formed from a material such that a distal tip of the guidewire is substantially straight at ambient temperature and the distal tip assumes a shape of a loop at body temperature.

8. The guiding catheter system of claim 5, wherein the guidewire comprises a sensor at a distal tip of the guidewire.

9. The guiding catheter system of claim 8, wherein the sensor comprises an electrode.

10. The guiding catheter system of claim 1, wherein the open guide lumen of the outer jacket is dimensioned to receive a medical electrical lead.

11. The guiding catheter system of claim 1, further comprising one or more secondary balloons integrated into the inflation lumen, the secondary balloons proximal to the distal balloon segment.

12. A method of cannulating a destination blood vessel, comprising:

introducing an outer jacket and a stylet of a catheter system into an access vessel;

rotating the stylet within a guide lumen of the outer jacket so that a pre-formed bend on a distal end of the stylet deflects the outer jacket to steer a distal end of the outer jacket;

advancing a guidewire through an open lumen of the stylet to engage the destination blood vessel with a distal end of the guidewire; and

inflating a balloon attached to a distal portion of the outer jacket to engage a portion of the access vessel or the destination blood vessel with the outer jacket.

13. The method of claim 12, wherein engaging the destination vessel with a distal end of the guidewire further comprises using a sensor disposed at the distal end of the guidewire to direct the distal end of the guidewire to the destination blood vessel.

14. The method of claim 13, wherein the sensor comprises an electrode.

15. The method of claim 12, further comprising advancing the outer jacket over the guidewire after the distal end of the guidewire has engaged the destination blood vessel to seat the outer jacket in the destination blood vessel.

16. The method of claim 12, further comprising removing the guidewire and stylet after seating the outer jacket in a destination blood vessel.

17. The method of claim 16, further comprising advancing an electrical medical lead through the outer jacket for passage into or through the destination blood vessel.

18. The method of claim 16, further comprising advancing an electrical medical lead through the outer jacket for passage into or through a left heart blood vessel or a left heart chamber.

19. The method of claim 12, wherein engaging a portion of the access vessel with the outer jacket further comprises inflating a second balloon attached to the outer jacket proximal to the balloon at the distal end.

20. A guiding catheter system for accessing a patient'"'"'s heart, comprising:

an outer jacket having an open guide lumen and a plurality of fluted balloons fixably mounted at a distal portion of the outer jacket, each of the fluted balloons fluidly coupled to an inflation lumen provided along a length of the outer jacket;

a stylet disposed within the guide lumen of the outer jacket, the stylet rotatable within the outer jacket along a longitudinal axis of the outer jacket, the stylet comprising an open lumen; and

a guidewire movably disposed within the open lumen of the stylet.

21. The guiding catheter system of claim 20, wherein the outer jacket further comprises a peel away feature provided along a longitudinal length of the outer jacket.

22. The guiding catheter system of claim 20, wherein the guidewire is formed from a material such that a distal tip of the guidewire is substantially straight at ambient temperature and the distal tip assumes a shape of a loop at body temperature.

23. The guiding catheter system of claim 20, wherein the guidewire comprises a sensor at a distal tip of the guidewire.

24. The guiding catheter system of claim 20, wherein the stylet comprises a pre-formed curve at a distal portion of the stylet, the pre-formed curve dimensioned to impart a deflection to the outer jacket.

25. The guiding catheter system of claim 20, further comprising one or more secondary balloons integrated into the inflation lumen, the secondary balloons proximal to the fluted balloons.