Guiding introducer for introducing medical devices into the coronary sinus and process for using same

• US 20020029030A1
• Filed: 08/15/2001
• Published: 03/07/2002
• Est. Priority Date: 08/13/1993
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: Daig Corporation (Abbott Laboratories Incorporated)
• Inventors: Benditt, David G., Starks, Daniel J., Lurie, Keith G., Blanc, Jean Jacques
• Granted Patent: US 6,656,166 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2210/125 Heart
• 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 25/0668 splittable, tear apart
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems

Abstract

A coronary sinus guiding introducer utilized to introduce medical devices, such as electrode leads, into the coronary sinus of a human heart. This guiding introducer contains a precurved distal portion, which curves through an arc of about 50 to 150 degrees. Preferably, the distal portion contains a pair of generally coplanar curves, wherein the arc of the first curve is from about 20 to about 60 degrees and the arc of the second curve is from about 30 to about 90 degrees and wherein the second curve is generally coplanar with the first curve. In an alternative embodiment, the second curve curves out of a plane formed by the first curve from about 15 to about 90 degrees. In addition, preferably the guiding introducer is splittable. Also disclosed is a process for introducing medical devices through the lumen of the precurved, coronary sinus guiding introducer.

Claims

1. A precurved coronary sinus guiding introducer comprising:

an elongated member with a proximal and distal end, a lumen extending through the elongated member from the proximal to the distal end, wherein the elongated member comprises a first generally straight, proximal section and a second precurved distal section, wherein the precurved distal section curves through an arc of about 50 to about 150 degrees.

2. The guiding introducer of claim 1 wherein the introducer is splittable from its proximal to its distal end.

3. The guiding introducer of claim 1 wherein the precurved distal section comprises a first and second curved portions wherein the first curved portion is curved in an arc of about 20 to about 60 degrees, wherein the second curved portion is curved in an arc of about 30 to 90 degrees, and wherein the first and second curved apportions are substantially coplanar.

4. The guiding introducer of claim 1 wherein the precurved distal section of the introducer comprises a first curved portion with a first arc and a second curved portion with a second arc, wherein the first curved portion is curved in substantially the same direction as the second curved portion, and wherein the sum of the arcs of the first and second curved portions is about 50 to about 150 degrees.

5. The guiding introducer of claim 4 wherein the sum of the arcs of the first and second curved portions is about 85 to about 115 degrees.

6. The guiding introducer of claim 3 wherein the arc of the first curved portion has a radius of about 2.0 (5.1 cm) to about 5.0 inches (12.7 cm).

7. The guiding introducer of claim 3 wherein the arc of the second curved portion has a radius of about 0.2 (0.5 cm) to about 2.0 inches (5.1 cm).

8. The guiding introducer of claim 1 wherein the precurved distal section comprises a first and second curved portion, wherein the first curved portion is curved in an arc of about 20 to about 60 degrees, wherein the second curved portion is curved in an arc of about 30 to 90 degrees, and wherein the second curved portion extends out of a plane formed by the first curved portion about 15 to about 90 degrees.

9. The guiding introducer of claim 1 wherein the precurved distal section comprises a plurality of curved sections and a plurality of straight sections resulting in an overall curve from about 50 to 150 degrees.

10. A process for introducing a medical device into the coronary sinus of a heart of a patient, comprising the steps of:

(a) introducing a stiffening means into a lumen of a coronary sinus guiding introducer, wherein the guiding introducer contains proximal and distal ends, and wherein the lumen extends from the proximal to the distal end of the guiding introducer,

(b) introducing the coronary sinus guiding introducer with stiffening means into vasculature of the patient,

(c) directing the coronary sinus guiding introducer with stiffening means through the vasculature of the patient into a right atrium of the patient'"'"'s heart,

(d) introducing a distal tip of the coronary sinus guiding introducer into the coronary sinus of the patient'"'"'s heart,

(e) introducing the medical device into the lumen of the coronary sinus guiding introducer, and

(f) advancing the medical device through the lumen of the coronary sinus guiding introducer until it extends away from the distal tip of the coronary sinus guiding introducer into the patient'"'"'s coronary sinus.

11. The process of claim 10 wherein the stiffening means is withdrawn from the coronary sinus guiding introducer prior to introducing the coronary sinus guiding introducer into the coronary sinus.

12. The process of claim 10 wherein the stiffening means is withdrawn from the coronary sinus guiding introducer after the introduction of the coronary sinus guiding introducer into the coronary sinus.

13. The process of claim 10 further comprising the steps of removing the coronary sinus guiding introducer from the patient by splitting it into separate, longitudinal portions.

14. The process of claim 10 wherein the stiffening means is a dilator.

15. The process of claim 10 wherein the stiffening means is a catheter.

16. The process of claim 10 wherein the medical device is a pacemaker lead.

17. The process of claim 10 wherein the coronary sinus guiding introducer comprises an elongated member containing a generally straight proximal section and a precurved, distal section, wherein the precurved, distal section is curved in an arc from about 50 to 150 degrees.

18. The process of claim 17 wherein the precurved distal section comprises first and second curved portions, wherein the first curved portion curves in an arc of about 20 to about 60 degrees, wherein the second curved portion curves in an arc of about 30 to 90 degrees, and wherein the first and second curved portions are substantially coplanar.

19. The process of claim 17 wherein the precurved distal section of the guiding introducer comprises a first curved portion with a first arc and a second curved portion with a second arc, wherein the first curved portion is curved in substantially the same direction as the second curved portion, and wherein the sum of the arcs of the first and second curved portions is about 50 to 150 degrees.

20. The process of claim 19 wherein the sum of the arcs of the first and second curved portions is from about 85 to about 115 degrees.

21. The process of claim 14 wherein the dilator comprises a precurved member, wherein the precurved member comprises a first generally straight proximal section and a second precurved, distal section, wherein the precurved, distal section curves through an arc of about 50 to about 150 degrees.

22. The process of claim 21 wherein the precurved distal section comprises a first and second curved portions wherein the first curved portion is curved in an arc of about 20 to about 60 degrees, wherein the second curved portion is curved in an arc of about 30 to 90 degrees, and wherein the first and second curved portions are substantially coplanar.

23. The process of claim 17 wherein the stiffening means is a dilator.

25. The precurved dilator of claim 24 wherein the precurved distal section comprises a first and second curved portions wherein the first curved portion is curved in an arc of about 20 to about 60 degrees, wherein the second curved portion is curved in an arc of about 30 to 90 degrees, and wherein the first and second curved portions are substantially coplanar.

24. A precurved dilator comprising an elongated member with a proximal and distal end, wherein the elongated member comprises a first generally straight, proximal section and a second precurved distal section, wherein the precurved distal section curves through an arc of about 50 to about 150 degrees.