Intraluminal visualization system with deflectable mechanism

• US 6,743,227 B2
• Filed: 03/30/2001
• Issued: 06/01/2004
• Est. Priority Date: 03/31/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Chan, Eric, Seraj, Mahmoud K., Kelley, James F.
• Primary Examiner(s): ROLLINS, ROSILAND STACIE
• Application Number:
  US09/822,678
• Publication Number:
  US 20010044624A1
• Time in Patent Office: 1,159 Days
• Field of Search: 606/41, 607/122, 600/585, 600/264, 604/264, 604/164.13, 604/528
• US Class Current: 606/41
• 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 25/0051 made from fenestrated or weakened tubing layer
• 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 25/0147 with movable mechanical means, e.g. pull wires
• 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
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

This is a combination method and system for intravascularly accessing and visualizing a body structure. A system is disclosed comprising a sheath, a balloon catheter, and a catheter deflection mechanism. A micro-deflection mechanism, which may be placed into the lumen of devices such as cardiac leads or electrophysiology catheters, is also provided for accurate guidance and placement of such devices to their target location. In one embodiment, a procedure for a lead or catheter placement is described in which a combination deflection mechanism, balloon catheter, and sheath assembly access the coronary sinus ostium via a superior approach. A distal balloon on the catheter is inflated and an occlusive venogram is obtained under fluoroscopic guidance to visualize the coronary veins. The sheath is advanced into the coronary sinus ostium and the balloon is deflated. The catheter and deflection mechanism are then removed. Next, a micro-deflection mechanism that has been inserted into the lumen of a cardiac lead is deployed through the sheath, allowing the lead to deflect with a high degree of accuracy and control as it is placed in the selected location.

Claims

1. A method of delivering an implantable medical device within a body, comprising the steps of;

advancing a first deflection mechanism, including a first shaft having a first shaft wall extending from a first proximal section to a first distal section, within the device;

deflecting the first deflection mechanism in a first predetermined pattern along the first distal section to correspondingly deflect the device in the first predetermined pattern, the first predetermined pattern corresponding to parameters of the first shaft wall;

advancing a sheath, having a sheath inner lumen, and a guide catheter disposed within the sheath inner lumen, within the body, the guide catheter including a shaft having a shaft wall and extending to a shaft distal tip, and a catheter inner lumen formed within the shaft;

inflating a balloon of the guide catheter;

advancing the sheath into the coronary sinus over the shaft of the guide catheter;

deflating the balloon;

withdrawing the guide catheter and the first deflection mechanism from the sheath;

placing a second deflection mechanism, including a second shaft having a second shaft wall extending from a second proximal section to a second distal section within a central lumen of a lead so that the second distal section engages a distal section of the lead;

advancing the second deflection mechanism and the lead within the sheath inner lumen within the coronary sinus; and

deflecting the second deflection mechanism in a second predetermined pattern along the second distal section to correspondingly defied the lead in the second predetermined pattern, the second predetermined pattern corresponding to parameters of the second shaft wall.

2. The method of claim 1, wherein the first shaft wall and the second shaft wall include a plurality of notches positioned along the first distal section and the second distal section, respectively, the plurality of notches being relatively spaced corresponding to the respective first predetermined pattern and second predetermined pattern.

3. The method of claim 2, wherein the plurality of notches have variable shapes and sizes.

4. The method of claim 2, wherein the first shaft wall and the second shaft wall have a variable thickness along the first distal section and the second distal section, respectively, the variable thickness corresponding to the respective first predetermined pattern and second predetermined pattern.

5. The method of claim 2, wherein the plurality of notches have variable depth.

6. The method of claim 1, wherein the first shaft wall and the second shaft wall have a variable thickness along the respective first distal section and second distal section corresponding to the respective first predetermined pattern and second predetermined pattern.

7. The method of claim 6, wherein the deflection of the first and second distal section corresponds to reduced thickness of the first shaft wall and the second shaft wall, respectively, as a function of one or both of length and circumferential position of the thickness.

8. A deflection system for delivering an implantable medical device within a targeted area of a body, comprising:

a first deflection mechanism adapted to be slidably inserted within the device, the first deflection mechanism including a first shaft having a first shaft wall extending from a first proximal section to a first distal section;

a spring positioned at the first distal section of the first shaft;

a pull wire extending through the first shaft and attached to the spring; and

a handle positioned at the first proximal section of the first shaft and affixed to the pull wire, wherein manipulation of the handle deflects the first shaft of the first deflection mechanism through the pull wire in a first predetermined pattern along the first distal section to correspondingly deflect the device in the first predetermined pattern, the first predetermined pattern corresponding to parameters of the first shaft wall;

a sheath having an inner lumen;

a catheter having an inflation member and adapted to be slidably inserted within the inner lumen of the sheath, the catheter having a catheter shaft, extending from a proximal section to a distal section, and a catheter inner lumen;

a medical electrical lead having a central lumen; and

a second deflection mechanism adapted to be slidably inserted within the central lumen of the lead, the second deflection mechanism including a second shaft having a second shaft wall extending from a second proximal section to a second distal section, wherein the second deflection mechanism is deflectable in a second predetermined pattern along the second distal section to correspondingly deflect the lead in the second predetermined pattern, the second predetermined pattern corresponding to parameters of the second shaft wall.

9. The deflection system of claim 8, wherein the first shaft wall and the second shaft wall include a plurality of notches positioned along the first distal section and the second distal section, respectively, the plurality of notches being relatively spaced corresponding to the respective first predetermined pattern and second predetermined pattern.

10. The deflection system of claim 9, wherein the plurality of notches have variable shapes and sizes.

11. The deflection system of claim 9, wherein the first shaft wall and the second shaft wall have a variable thickness along the first distal section and the second distal section, respectively, the variable thickness corresponding to the respective first predetermined pattern and second predetermined pattern.

12. The deflection system of claim 9, wherein the plurality of notches have variable depth.

13. The deflection system of claim 8, wherein the first shaft wall and the second shaft wall have a variable thickness along the respective first distal section and second distal section corresponding to the respective first predetermined pattern and second predetermined pattern.

14. The deflection system of claim 13, wherein the deflection of the first and second distal section corresponds to reduced thickness of the first shaft wall and the second shaft wall, respectively, as a function of one or both of length and circumferential position of the thickness.