Guide catheters for accessing cardiac sites

• US 20060247751A1
• Filed: 04/28/2005
• Published: 11/02/2006
• Est. Priority Date: 04/28/2005
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Seifert, Kevin R.
• Granted Patent: US 7,974,710 B2
• Time in Patent Office: Days
• US Class Current: 607/122
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

Guide catheters and methods of using same for facilitating implantation of cardiac leads for applying electrical stimulation to and/or sensing electrical activity of the heart through one or more electrode positioned at an implantation site within a heart chamber or cardiac vessel adjacent a heart chamber and more particularly to a method and apparatus for introducing such a cardiac lead having low torqueability and pushability through a pathway to enable attachment of the cardiac lead at the implantation site are disclosed. The catheter body comprises delivery lumen to introduce a small diameter cardiac lead and a guide lumen to receive a guide tool to locate the catheter body distal end at the implantation site. The small diameter lumen within a small diameter guide tube extends distally from the delivery exit port of the delivery lumen. The catheter body is shaped to bias the delivery lumen exit port toward the heart.

Claims

1. A guide catheter for introducing a cardiac lead having a distal fixation mechanism through a pathway from an incision to an implantation site relative to a heart chamber, comprising:

an elongated catheter body extending between a catheter body proximal end and a catheter body distal end, the catheter body having a catheter body sidewall and comprising a proximal portion and a distal leader extending distally from the distal end of the proximal portion;

the catheter body sidewall enclosing a guide lumen extending between a guide lumen entry port and the catheter body distal end, the guide lumen diameter sized to receive a guide tool inserted therein to aid in steering the guide catheter body through the pathway;

the proximal portion of the catheter body sidewall enclosing a delivery lumen extending between a delivery lumen entry port and a delivery lumen exit port through the catheter body sidewall proximal to the catheter body distal end; and

at least one of the proximal portion and distal leader of the catheter body shaped in at least a segment thereof to bias the delivery lumen exit port toward the heart during advancement through the pathway to facilitate passage of the fixation mechanism of the cardiac lead through a vessel wall into the myocardium.

2. The guide catheter of claim 1, wherein the delivery lumen includes a delivery lumen diameter sized to receive the cardiac lead having a lead body enclosing a lead conductor and extending between a proximal lead connector element and a distal electrode to enable introduction of the cardiac lead through the pathway to the implantation site.

3. The guide catheter of claim 1, wherein the cardiac lead fixation mechanism is one of a fixation helix adapted to be screwed through the vessel wall into the myocardium or a hook or a prong adapted to be extended through the vessel wall into the myocardium.

4. The guide catheter of claim 1, wherein the guide lumen terminates in a guide lumen exit port in the distal leader formed to receive a guide tool inserted into the guide lumen as the guide catheter is advanced over the guide tool.

5. The guide catheter of claim 1, wherein the catheter body is formed with the delivery lumen having a delivery lumen axis and the guide lumen having a guide lumen axis extend in side-by-side relation through the proximal portion, wherein the proximal portion of the catheter body preferentially bends in a preferential bending direction substantially transverse to a geometric axis plane defined by the delivery lumen axis and the guide lumen axis, wherein the delivery lumen exit port is oriented in the preferential bending direction.

6. The guide catheter of claim 5, wherein the guide catheter body includes at least one substantially flat major side that extends along at least a segment of the proximal portion of the catheter body substantially parallel with the axis plane, the flat major side generating the preferential bending and biasing the delivery lumen exit port toward the heart during advancement of the guide catheter body through the pathway to facilitate passage of the fixation mechanism of the cardiac lead through the vessel wall into the myocardium.

7. The guide catheter of claim 6, wherein the distal end of the delivery lumen includes a curved portion proximal to the delivery lumen exit port that deflects the distal fixation mechanism of the cardiac lead out of the axis plane and toward the preferential bending direction.

8. The guide catheter of claim 5, wherein the distal end of the delivery lumen is curved into a guide bend proximal to the delivery lumen exit port that deflects the distal fixation mechanism of the cardiac lead out of the axis plane and toward the preferential bending direction.

9. The guide catheter of claim 1, wherein the catheter body is formed with the delivery lumen having a delivery lumen axis and the guide lumen having a guide lumen axis extending in side-by-side relation through the proximal portion, the delivery lumen axis and the guide lumen axis defining a geometric axis plane, and the catheter body includes a flange extending transverse to the axis plane to form at least one substantially flat surface that enables preferential bending of the catheter body substantially transverse to the axis plane, and wherein the delivery lumen exit port is oriented in the preferential bending direction.

10. The guide catheter of claim 9, wherein the distal end of the delivery lumen includes a curved portion proximal to the delivery lumen exit port that deflects the distal fixation mechanism of the cardiac lead out of the axis plane and toward the preferential bending direction.

11. A guide catheter for introducing a plurality of cardiac leads having distal fixation mechanisms through a pathway from an incision to implantation sites relative to a heart chamber, comprising:

an elongated catheter body extending between a catheter body proximal end and a catheter body distal end, the catheter body having a catheter body sidewall and comprising a proximal portion and a distal leader extending distally from the distal end of the proximal portion;

the catheter body enclosing a guide lumen extending between a guide lumen entry port and the catheter body distal end, the guide lumen diameter sized to receive a guide tool inserted therein to aid in steering the guide catheter body through the pathway;

the proximal portion of the catheter body enclosing a first delivery lumen extending between a first delivery lumen entry port and a first delivery lumen exit port through the catheter body sidewall disposed along the catheter body proximal to the catheter body distal end and a second delivery lumen extending between a first delivery lumen entry port and a second delivery lumen exit port through the catheter body sidewall disposed along the catheter body proximal to the catheter body distal end; and

at least one of the proximal portion and distal leader of the catheter body shaped in at least a segment thereof to bias one of the first delivery lumen exit port and the second delivery lumen exit port toward the heart during advancement through the pathway to facilitate passage of the fixation mechanism of the cardiac lead through the vessel wall into the myocardium.

12. The guide catheter of claim 11, wherein the first and second delivery lumens have a delivery lumen diameter sized to receive a cardiac lead to enable introduction of the cardiac lead through the pathway to the implantation site.

13. The guide catheter of claim 11, wherein the guide lumen terminates in a guide lumen exit port in the distal leader enabling advancement of the guide catheter over a guide tool inserted into the guide lumen.

14. The guide catheter of claim 11, wherein the guide lumen is sized in guide lumen diameter to receive a guide tool inserted through the guide lumen entry port, the guide tool comprising one of a guide wire, a stiffening stylet, and a steerable stylet.

15. The guide catheter of claim 11, wherein a plurality of bends are formed in a distal segment of the proximal portion of the catheter body and the distal leader that bear against the vessel wall to urge the first and second delivery lumen exit ports toward the heart.

16. A guide catheter for introducing a cardiac lead having a distal fixation mechanism through a pathway from an incision to an implantation site relative to a heart chamber, comprising:

an elongated catheter body extending between a catheter body proximal end and a catheter body distal end, the catheter body having a catheter body sidewall and comprising a proximal portion and a distal leader extending distally from the distal end of the proximal portion;

the catheter body sidewall enclosing a guide lumen having a guide lumen axis and extending between a guide lumen entry port and the catheter body distal end, the guide lumen diameter sized to receive a guide tool inserted therein to aid in steering the guide catheter body through the pathway;

the proximal portion of the catheter body sidewall enclosing a delivery lumen having a delivery lumen axis and extending between a delivery lumen entry port and a delivery lumen exit port through the catheter body sidewall proximal to the catheter body distal end, wherein the delivery lumen and the guide lumen extend in side-by-side relation through a proximal segment of the proximal portion and a geometric axis plane is defined by the delivery lumen axis and guide lumen axis having a first orientation that causes the proximal segment of the proximal portion to preferentially bend in a direction transverse to the axis plane and to bias the delivery lumen exit port toward a blood vessel wall at the implantation site.

17. The guide catheter of claim 16, wherein the geometric axis plane in a distal segment of the proximal portion of the catheter body is substantially orthogonal to the first orientation to orient the delivery lumen exit port out of the first orientation of the axis plane.

18. The guide catheter of claim 17, wherein the guide catheter body is shaped to have at least one substantially flat major side that extends along at least a segment of the proximal portion of the catheter body substantially parallel with the first orientation of the axis plane that augments the preferential bending and biases the delivery lumen exit port toward the heart during advancement through the pathway to facilitate passage of the fixation mechanism of the cardiac lead through the vessel wall into the myocardium.

19. The guide catheter of claim 18, wherein the distal end of the delivery lumen includes a curved portion forming a guide bend proximal to the delivery lumen exit port that deflects the distal fixation mechanism of the cardiac lead out of the axis plane and toward the preferential bending direction.

20. The guide catheter of claim 17, further comprising:

an inner tube positioned along the proximal segment of the proximal portion of the guide catheter body enclosing the guide lumen and delivery lumen in side-by-side relation that is shaped to have at least one substantially flat major side that extends along at least a segment of the proximal portion of the catheter body substantially parallel with the first orientation of the axis plane, the flat major side generating the preferential bending and biasing the delivery lumen exit port toward the heart during advancement of the guide catheter through the pathway to facilitate passage of the fixation mechanism of the cardiac lead through the vessel wall into the myocardium; and

an outer sheath formed over the inner tube having a substantially cylindrical sheath outer surface.

21. The guide catheter of claim 16, wherein the delivery lumen has a delivery lumen diameter sized to receive the cardiac lead to enable introduction of the cardiac lead through the pathway to the implantation site.

22. The guide catheter of claim 16, wherein the guide lumen terminates in a guide lumen exit port in the distal leader enabling advancement of the guide catheter over a guide tool inserted into the guide lumen.

23. The guide catheter of claim 22, wherein the guide tool comprises a guide wire advanced through the pathway distal to the catheter body distal end.

24. The guide catheter of claim 16, wherein the guide lumen is sized in guide lumen diameter to receive a guide tool inserted through the guide lumen entry port, the guide tool comprising one of a guide wire, a stiffening stylet, and a steerable stylet.