Method and system for delivery of a medical electrical lead within a venous system

• US 6,836,687 B2
• Filed: 04/25/2002
• Issued: 12/28/2004
• Est. Priority Date: 03/31/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sommer, John L., Gardeski, Kenneth C., Meregotte, Pedro A., Hine, Douglas S., Bjorklund, Vicki L., Kelley, James F., Spear, Stanten C., Maier, John J., Vaughn, James H.
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US10/131,388
• Publication Number:
  US 20020165536A1
• Time in Patent Office: 978 Days
• Field of Search: 606/1, 606/41, 607/115, 607/116, 607/114, 607/122, 607/126, 604/164.01, 604/164.02, 604/164.13, 604/264
• US Class Current: 607/122
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61M 2025/0042 Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0047 the inner layer having a higher lubricity
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0161 wherein the distal tips have two or more deflection regions
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0054 with regions for increasing flexibility
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: A61M 39/0613 with means for adjusting the seal opening or pressure A61M39/0693 takes precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

A system for delivering a medical electrical lead within a coronary venous system that includes an introducer kit for establishing venous access to the coronary venous system and a plurality of delivery sheaths, each corresponding to a desired approach to a coronary sinus of the coronary venous system and insertable within the coronary venous system through the navigation pathway. A hemostasis valve is coupled to a delivery sheath of the plurality of delivery sheaths, and a guide wire is inserted within the lead lumen, guiding delivery of the distal tip of the medical electrical lead to a target site within the coronary venous system through the hemostasis valve and the delivery sheath. Subsequent to the distal tip being delivered to the target sight, the hemostasis valve is advanced over the connector of the medical electrical lead to remove the hemostasis valve from the medical electrical lead.

Claims

1. A method of delivering a medical electrical lead within a coronary venous system, comprising the steps of:

establishing venous access to the coronary venous system using an introducer tool kit;

choosing a delivery sheath from a plurality of delivery sheaths corresponding to a desired approach to a coronary sinus of the coronary venous system;

coupling a hemostasis valve over a proximal portion of the delivery sheath;

positioning the delivery sheath within the venous access;

inserting a guide wire within a lead lumen at a distal tip of the medical electrical lead;

inserting the distal tip of the medical electrical lead through the hemostasis valve and within the delivery sheath;

guiding advancement of the distal tip of the medical electrical lead to a target site within the coronary venous system using the guide wire; and

decoupling the hemostasis valve from the delivery sheath and advancing the hemostasis valve over a connector of the medical electrical lead to remove the hemostasis valve from the medical electrical lead.

2. The method of delivering a medical electrical lead within a coronary venous system according to claim 1, wherein the guide wire is a stylet having a stylet knob, and the step of decoupling the hemostasis valve includes advancing the hemostasis valve over the stylet knob to remove the hemostasis valve from the medical electrical lead.

3. The method of delivering a medical electrical lead within a coronary venous system according to claim 2, further comprising the step of fixedly engaging the connector within a loading tool, wherein the step of inserting the guide wire includes loading the stylet wire within the lead lumen using the loading device, and wherein the step of decoupling the hemostasis valve includes advancing the hemostasis valve over the loading tool to remove the hemostasis valve from the medical electrical lead.

4. The method of delivering a medical electrical lead within a coronary venous system according to claim 1, wherein the step of decoupling the hemostasis valve includes advancing the hemostasis valve over an anchoring sleeve positioned on the lead.

5. The method of delivering a medical electrical lead within a coronary venous system according to claim 1, wherein the step of positioning the delivery sheath includes inserting the delivery sheath within the coronary venous system using one of a steerable catheter and an introducer guide wire.

6. The method of delivering a medical electrical lead within a coronary venous system according to claim 5, further comprising the step of securing excess length of one of the guide wire and the introducer guide wire to prevent the excess length from entering a sterile field while allowing repositioning of the guide wire and the introducer guide wire.

7. The method of delivering a medical electrical lead within a coronary venous system according to claim 1, wherein the connector is an IS-1 connector.

8. The method of delivering a medical electrical lead within a coronary venous system according to claim 1, wherein the plurality of delivery sheaths include a left-sided venous access delivery sheath and a right-sided delivery sheath.

9. The method of delivering a medical electrical lead within a coronary venous system according to claim 1 wherein the medical electrical lead is one of an over-the-wire lead and a side-lumen lead.

10. The method of delivering a medical electrical lead within a coronary venous system according to claim 1, further comprising the step of inserting a balloon catheter within the delivery sheath to obtain a venogram to guide advancement of the guide wire and the lead to the target site.

11. A system for delivering a medical electrical lead within a coronary venous system, the medical electrical lead extending from a connector to a distal tip and having a lead lumen located at the distal tip, the system comprising:

an introducer kit establishing venous access to the coronary venous system;

a plurality of delivery sheaths, each corresponding to a desired approach to a coronary sinus of the coronary venous system and insertable within the coronary venous system through the navigation pathway;

an anchoring sleeve positioned along the medical electrical lead;

a hemostasis valve coupled to a delivery sheath of the plurality of delivery sheaths; and

a guide wire insertable within the lead lumen, guiding delivery of the distal tip of the medical electrical lead to a target site within the coronary venous system though the hemostasis valve and the delivery sheath, wherein, subsequent to the distal tip being delivered to the target sight, the hemostasis valve is advanced over the connector and the anchoring sleeve of the medical electrical lead to remove the hemostasis valve from the medical electrical lead.

12. The system of claim 11, wherein the guide wire is a stylet having a stylet knob, and the hemostasis valve is advanced over the stylet knob to remove the hemostasis valve from the medical electrical lead.

13. The system of claim 12, further comprising a loading device fixedly engaged with the connector to load the stylet wire within the lead lumen, wherein the hemostasis valve is advanced over the loading tool to remove the hemostasis valve from the medical electrical lead.

14. The system of claim 13, wherein the connector is an IS-1 connector.

15. The system of claim 14, wherein the tool kit includes a steerable catheter and an introducer guide wire, and wherein the delivery sheath is inserted within the coronary venous system through the navigation pathway using one of the steerable catheter and the introducer guide wire.

16. The system of claim 15, further comprising a guide wire clip capable of being positioned in one of a non-engaging open position and an engaging closed position, the guide wire clip securing excess length of one of the guide wire and the introducer guide wire to prevent the guide wire and the introducer guide wire from entering a sterile field while allowing repositioning of the guide wire and the introducer guide wire when the guide wire clip is in the closed position.

17. The system of claim 16, wherein the plurality of delivery sheaths include a left-sided venous access delivery sheath and a right-sided delivery sheath.

18. The system of claim 17, wherein the medical electrical lead is one of an over-the-wire lead and a side-lumen lead.