System and method for placing a medical electrical lead

• US 6,697,677 B2
• Filed: 04/05/2001
• Issued: 02/24/2004
• Est. Priority Date: 12/28/2000
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gardeski, Kenneth C., Pedersen, Brad D., Dahl, Roger, Zytkovicz, Duane
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US09/826,730
• Publication Number:
  US 20020147484A1
• Time in Patent Office: 1,055 Days
• Field of Search: 600/372-381, 600/505, 607/122-132, 607/116, 607/119
• US Class Current: 607/128
• 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 2001/058 Fixing tools
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

An improved system and method that is capable of delivering multiple electrode assemblies to predetermined implant sites within a body is disclosed. The system includes an elongated member such as an introducer sheath. The introducer includes an elongated channel along at least a distal end portion of the introducer. The elongated channel opens to the exterior surface of the introducer through an elongated slot. One or more electrode assemblies may be retained within the elongated channel such that the leads exit the introducer via the elongated slot. The elongated introducer further includes a lumen that is in fluid communication with channel through openings, or gaps. The electrode assemblies are loaded within the channel at predetermined positions with respect to the openings. A distal end of a stiffening member such as a stylet may then be advanced within the lumen and through a selected one of the openings to engage an electrode assembly. The distal end of the stylet, along with the electrode assembly, is pushed in a distal direction within the channel until the electrode assembly exits the channel at a predetermined implant site. The stylet is then de-coupled from the electrode assembly, and the distal end is again retracted into the lumen. The distal end of the stiffening member may be re-directed into a different opening to engage a second electrode assembly. After the introducer is repositioned at a second implant site, the second electrode assembly may be deployed in a manner similar to that discussed above. The process may be repeated to deploy an array of electrodes. According to one aspect of the invention, the stylet distal end is canted to extend from the lumen of the introducer into the channel.

Claims

1. An electrode assembly system, comprising:

an elongated member including a first lumen forming a cutaway portion and a second lumen substantially parallel to the first lumen, the first lumen in fluid communication with an external surface of the elongated member via the cutaway portion; and

a plurality of electrode assemblies positioned within the first lumen, wherein the first lumen and the second lumen form one or more apertures, the first lumen being in fluid communication with the second lumen via the one or more apertures.

2. The electrode assembly system of claim 1, further comprising a stiffening member inserted within the second lumen.

3. The electrode assembly system of claim 2, wherein the stiffening member includes marker means for enabling the stiffening member to be positioned at one or more predetermined locations within the second lumen.

4. The electrode assembly system of claim 2, wherein the stiffening member is a canted stylet adapted to be advanced within the first lumen from the second lumen through the one or more apertures to engage the plurality of electrode assemblies and advance the plurality of electrode assemblies through the first lumen and outward from a distal end of the elongated member.

5. The electrode assembly system of claim 4, wherein the canted stylet includes a keyed structure to engage the plurality of electrode assemblies.

6. The electrode assembly system of claim 4, wherein one of the plurality of electrode assemblies includes an expandable member adapted to expand after being advanced outward from the distal end of the elongated member.

7. The electrode assembly system of claim 6, wherein the expandable member is an expandable tine.

8. The electrode assembly system of claim 6, wherein the expandable member is an expandable braided structure.

9. The electrode assembly system of claim 6, wherein the expandable member is a deformable, substantially tubular structure.

10. The electrode assembly system of claim 4, further comprising:

a plurality of lead bodies;

a plurality of conductors, each of the plurality of conductors positioned within a corresponding one of the plurality of lead bodies and coupling an electrode assembly of the plurality of electrode assemblies to a proximal end of the corresponding one of the plurality of lead bodies;

a connector pin positioned proximally from the plurality of lead bodies;

a connector assembly positioned distally from the connector pin; and

a common conductor extending from the connector pin to the connector assembly and electrically coupling the plurality of conductors to the connector pin, wherein the stiffening member is extended outside and along the connector assembly and the plurality of lead bodies to engage the plurality of electrodes during advancing of the plurality of electrode assemblies via the stiffening member.

11. The electrode assembly system of claim 10, wherein the plurality of electrode assemblies include a first electrode electrically coupled to a first conductor of the plurality of conductors and a second electrode electrically coupled to a second conductor of the plurality of conductors, and wherein the stiffening member is advanced to the first conductor to deploy the first electrode along a first site of the multiple sites and to the second conductor to deploy the second conductor along a second site of the multiple sites different from the first site while the first conductor is deployed along the first site.

12. The electrode assembly system of claim 11, wherein the first conductor has a first conductor length and the second conductor has a second conductor length greater than the first conductor length.

13. The electrode assembly system of claim 4, wherein the plurality of electrode assemblies include a slotted portion receiving the stiffening member during the advancing of the plurality of electrode assemblies via the stiffening member.

14. The electrode assembly system of claim 4, wherein the plurality of electrode assemblies assume a first shape, corresponding to the elongated member, prior to the advancing of the plurality of electrode assemblies and a second shape subsequent to the advancing of the plurality of electrode assemblies.

15. The electrode assembly system of claim 4, wherein the plurality of electrode assemblies assume a first non-tubular shape immediately following the advancing of the plurality of electrode assemblies outward from the distal end of the elongated member and a generally tubular shape subsequent to assuming the non-tubular shape.

16. The electrode assembly system of claim 4, wherein an electrode assembly of the plurality of electrode assemblies is an expandable electrode.

17. The electrode assembly system of claim 16, wherein the electrode assembly of the plurality of electrode assemblies includes a collar engaging the stiffening member during deployment.

18. The electrode assembly system of claim 16, further comprising:

a plurality of lead bodies; and

a plurality of conductors, each of the plurality of conductors positioned within a corresponding one of the plurality of lead bodies and coupling an electrode assembly of the plurality of electrode assemblies to a proximal end of the corresponding one of the plurality of lead bodies, wherein the electrode assembly of the plurality of electrode assemblies is formed of a braided elastic material and includes conductive strands electrically coupled to a corresponding conductor of the plurality of conductors.

19. The electrode assembly system of claim 1, further comprising an inflation member adapted to temporarily retain the elongated member at a predetermined location within a body.

20. The electrode assembly system of claim 1, further comprising a plurality of lead bodies, wherein each of the plurality of electrode assemblies is coupled to a lead body of the plurality of lead bodies extending through the cutaway portion and positioned adjacent the external surface of the elongated member.

21. The electrode assembly system of claim 20, further comprising a sheath surrounding ones of the plurality of lead bodies.

22. The electrode assembly system of claim 21, wherein the sheath includes a tether to the elongated member.

23. The electrode assembly system of claim 1, wherein the one or more electrode assemblies are formed from a deformable superelastic alloy.

24. The electrode assembly system of claim 23, wherein the deformable superelastic alloy is Nitonal.