Apparatus for removing an elongated structure implanted in biological tissue

• US 20020010475A1
• Filed: 05/17/2001
• Published: 01/24/2002
• Est. Priority Date: 05/17/2000
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Vascular Incorporated (Cook Group Incorporated)
• Inventors: Lui, Chun K.
• Granted Patent: US 6,712,826 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

Disclosed is a heart lead removal apparatus for removing an range of different sized implanted cardiac pacemaker or defibrillator leads from the heart, typically through a blood vessel leading to the heart. The lead removal apparatus comprises a stylet, an expandable portion, and an actuator portion which is manually advanced by the operator to cause the expandable portion to engage the coils within a pacemaker coil lumen. In one preferred embodiment, the expandable portion comprises a multifilar wire bundle that is helically wound around the stylet and attached about the tip thereof. The actuator portion, which comprises an elongate metal cannula attached to a first handle, is urged forward to contact the proximal end of the expandable portion, thereby causing the individual wires of the multifilar wire bundle to deform outward in a random fashion.

Claims

1. A lead removal apparatus for removing an implanted, lead from a patient, the lead including a coiled structure having a passageway extending longitudinally therein, comprising:

a stylet having a distal end;

an expandable portion comprising a plurality of expandable members and having a first diameter sized for insertion into the passageway of the coiled structure, wherein the expandable portion is disposed over the stylet and attached about the distal portion of the stylet;

an actuator portion disposed proximal the expandable portion, wherein the expandable portion is longitudinally moveable and laterally expandable to a second diameter when the actuator portion is urged against the expandable portion, thereby resulting in one or more of the plurality of expandable members expanding laterally to engage the coiled structure when situated in the passageway thereof; and

wherein the expandable portion is adapted such that the second diameter is sufficiently large for the lead removal apparatus to engage with a plurality of different sizes of the lead in which the diameter of the coiled structure passageway ranges from at least 0.4 mm to at least 0.9 mm.

2. The lead removal apparatus of claim 1 wherein the plurality of expandable members comprise a plurality of wires.

3. The lead removal apparatus of claim 1 the expandable portion comprises a multifilar wire bundle that includes a series of helical windings around the stylet, the multifilar wire bundle comprising a plurality of wires.

4. The lead removal apparatus of claim 3 wherein the multifilar wire bundle includes at least four wires.

5. The lead removal apparatus of claim 3 wherein the multifilar wire bundle includes at least six wires.

6. The lead removal apparatus of claim 3 wherein the multifilar wire bundle includes spaces between the adjacent helical windings of the multifilar bundle.

7. The lead removal apparatus of claim 5 wherein the expandable member comprises a proximal section, an intermediate section, and a distal section, wherein the adjacent helical windings each include a space therebetween, the width of at least one space located between the adjacent helical windings of the intermediate section being greater than the width of the space located between the adjacent windings of the proximal and distal sections.

8. The lead removal apparatus of claim 1 wherein the actuator portion comprises an elongated cannula.

9. The lead removal apparatus of claim 8 wherein the actuator portion further includes a handle attached about the proximal end thereof.

10. The lead removal apparatus of claim 9 wherein the actuator handle includes a deployment guard to prevent premature advancement of the actuator portion, the deployment guard manipulable by an operator to selectively permit advancement of the actuator portion.

11. The lead removal apparatus of claim 10 wherein the stylet includes a handle attached therealong, the stylet handle being interconnected with the actuator handle via the deployment guard such that the deployment guard is either severable or disconnectable from at least one of the stylet handle and actuator handle to allow advancement of the actuator portion relative to the stylet.

12. The lead removal apparatus of claim 1 wherein the actuator portion is integrally part of the expandable portion.

13. A lead removal apparatus for removing an implanted, cardiac lead from a patient, the lead including a coiled structure having a passageway extending longitudinally therein, comprising:

a stylet having a distal end;

an expandable portion comprising a multifilar wire bundle that includes a series of helical windings around the stylet, the expandable portion being attached about the distal end of the stylet, wherein the helical windings of the multifilar wire bundle of at least an intermediate section of the expandable portion include a series of gaps therebetween, the individual wires of the multifilar bundle being closely spaced together; and

an actuator portion disposed proximal the expandable portion, wherein the expandable portion is longitudinally moveable and laterally expandable to a second diameter when the actuator portion is urged against the expandable portion, thereby resulting in one or more of the plurality of expandable members expanding laterally to engage the coiled structure when situated in the passageway thereof.

14. The lead removal apparatus of claim 13 wherein the multifilar wire bundle includes at least four wires.

15. The lead removal apparatus of claim 13 wherein the multifilar wire bundle includes at least six wires.

16. The lead removal apparatus of claim 13 wherein the actuator portion comprises an elongated cannula.

17. A lead removal apparatus for removing an implanted, cardiac lead from a patient, the lead including a coiled structure having a passageway extending longitudinally therein, comprising:

a stylet having a distal end;

an expandable portion comprising a plurality of expandable members comprising a multifilar wire bundle comprising annealed stainless steel wires, the mulitfilar wire bundle including a series of helical windings around the stylet, the expandable portion being attached to the stylet, the stylet and expandable portion being sized for insertion into the passageway;

an actuator portion disposed proximal the expandable portion, wherein the expandable portion is longitudinally moveable and laterally expandable to a second diameter when the actuator portion is urged against the expandable portion, thereby resulting in one or more of the plurality of expandable members expanding laterally to engage the coiled structure when situated in the passageway thereof; and

wherein the expandable portion is adapted such that the second diameter is sufficiently large for the lead removal apparatus to engage a plurality of different sizes of the lead in which the diameter of the coiled structure passageway is at least 0.4 mm to at least 0.9 mm.