Cardiac electrode and method for installing same

• US 4,452,254 A
• Filed: 07/13/1981
• Issued: 06/05/1984
• Est. Priority Date: 07/13/1981
• Status: Expired due to Fees

• Current Assignee: Goldberg, Edward M., Seymour Bazell
• Original Assignee: Goldberg, Edward M., Seymour Bazell
• Inventors: Goldberg, Edward M., Bazell, Seymour
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Shein, Mitchell J.
• Application Number:
  US06/282,750
• Time in Patent Office: 1,058 Days
• Field of Search: 128/419 P, 128/784, 128/785, 128/786
• US Class Current: 607/127
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

A novel cardiac lead assembly is described which includes an elongatable coil spring which serves to connect a screw-in electrode tip with a connector. A flange is affixed to the electrode tip and the lead is positioned inside a tubular lead insertion device. In order to install this lead in a heart, the coil spring is stretched while using the installation device to position the flange precisely with respect to the heart. Once proper position of the electrode tip has been assured, the coil spring is released abruptly such that the potential energy of the spring propels the electrode tip against the heart with sufficient momentum to embed the electrode tip in the heart in a single motion. Preferably, the spring also imparts an angular momentum to the electrode tip which tends to screw the electrode tip into the heart. The illustrated embodiments of the lead include a plurality of spirally oriented elongated prongs which serve to engage the surface of the heart mechanically. Also, a braided wire sheath is disclosed which is rigidly attached to the flange at its distal end and serves to transmit torques down the length of the lead efficiently for screwing the lead into or out of the heart as desired.

Claims

1. A method for attaching an electrical lead to a heart comprising the following steps:

providing a cardiac lead assembly which comprises an elongated cardiac lead, with an exposed electrically conductive electrode tip, projecting axially from the one end of the cardiac lead that serves as an attachment end, and a lead insertion device for holding the cardiac lead;

pointing the electrode tip at a selected portion of a heart but spaced from the heart; and

then

accelerating the electrode tip, at its position spaced from the heart, as a projectile pointed toward the heart and away from the lead insertion device to provide the electrode tip with a momentum sufficient to cause the electrode tip to penetrate a surface of the heart, thereby embedding the electrode tip in the heart.

2. The invention of claim 1 wherein the electrode tip is a screw-in electrode tip and the acceleration step imparts an angular momentum to the cardiac lead and the electrode tip, which angular momentum tends to screw the screw-in electrode tip into the heart.

7. The invention of claim 1 or 3 or 5 wherein the portion of the heart is located on an exterior surface of the heart and the cardiac lead is an epicardial lead.

8. The invention of claim 1 or 3 or 5 wherein the portion of the heart is located on an interior surface of the heart and the cardiac lead is an endocardial lead.

3. A method for attaching an electrical lead to a heart comprising the following steps:

providing a cardiac lead assembly which comprises an elongated cardiac lead, with an exposed electrically conductive electrode tip, projecting axially from one end of the cardiac lead, to serve as an attachment end, a biasing member coupled to the electrode tip, and a lead insertion device for holding the cardiac lead;

selectively moving the biasing member with respect to the insertion device into a biased position, thereby storing potential energy in the biasing member;

pointing the electrode tip at a selected portion of the heart, but spaced from said selected heart portion; and

releasing the biasing member from the biased position to allow the biasing member to accelerate the electrode tip as a projectile, toward the heart and away from the insertion device, and so as to provide the electrode tip with a momentum sufficient to cause the electrode tip to penetrate a surface of the heart, thereby embedding the electrode tip in the heart.

4. The invention of claim 3, wherein the electrode tip is a screw-in tip and the biasing member operates to impart an angular momentum to the cardiac lead and the electrode tip, which angular momentum tends to screw the screw-in electrode tip into the heart.

5. A method for attaching an electrical lead to a heart comprising the following steps:

providing a cardiac lead assembly which comprises a cardiac lead, a coil spring included in the lead, a screw-in electrode tip secured to the coil spring, and a tubular insertion device disposed about the lead;

extending the coil spring against the insertion device into an extended position, thereby storing potential energy in the coil spring and urging the electrode tip toward the insertion device;

pointing the electrode tip at a portion of a heart; and

then

releasing the coil spring from the extended position, thereby propelling the electrode tip toward the heart and away from the insertion device to provide the electrode tip with a momentum sufficient to cause the electrode tip to penetrate a surface of the heart, thereby embedding the electrode tip in the heart.

6. The invention of claim 5 wherein the coil spring operates to impart an angular momentum to the electrode tip, which angular momentum tends to screw the screw-in electrode tip into the heart.

9. A cardiac lead assembly comprising:

an axially elongated electrical lead;

an electrically conductive electrode tip, included in the lead and positioned to extend away from one end of the lead; and

means for simultaneously accelerating, as a projectile, the electrical lead and the electrode tip both axially of and angularly about the longitudinal axis of the electrode lead, toward a portion of the heart that is spaced from the electrode tip, with a momentum sufficient to cause the electrode tip to penetrate a surface of a heart, thereby embedding the electrode tip in the heart.

10. The invention of claim 9 wherein the electrode tip is a screw-in electrode tip and the accelerating means includes means for imparting an angular momentum to the electrode tip, which angular momentum tends to screw the screw-in electrode tip into the heart.

11. The invention of claim 9 wherein said electrical lead further comprises an annular metal flange concentric about the axis of the lead and its electrode tip, and being secured adjacent to and surrounding but spaced from the electrode tip such that the tip extends axially outwardly relative to the flange, and with the metal flange being electrically insulated from the electrode tip and from the electrical lead.

12. The invention of claim 11 wherein the annular flange defines at least one elongated prong positioned on the flange, and adapted to penetrate and mechanically engage and grip the heart when the lead is selectively manually rotated about its axis, thereby securing the flange and the lead to the heart.

13. The invention of claim 12 wherein said at least one prong comprises two prongs, wherein each of the prongs is oriented in a spiral axial pattern relative to the annular flange such that the prongs cooperate to urge respective portions of the heart toward the lead tip.

14. The invention of claim 9 wherein the accelerating means comprises a tubular structure positioned around the lead, wherein the electrode tip comprises a screw-in electrode tip, and wherein the lead assembly further comprises means for transmitting torque from the tubular structure to the screw-in electrode tip.

15. The invention of claim 9, wherein the accelerating means comprises:

a tubular structure positioned around a portion of the lead and providing abutment means thereon for cooperation with the lead for limiting axial and rotational movement of the lead relative to the tubular structure;

a coil spring, included in the lead and extending along the length of the lead; and

a handle operatively associated with the coil spring for selectively potentiating the coil spring of the lead against the abutment means on the tubular structure.

16. The invention of claim 15 wherein the lead further comprises a transverse flange secured to the coil spring of the lead adjacent the electrode tip, and one end of the tubular structure being adapted to bear against the transverse flange.

17. A cardiac lead assembly comprising:

an electrical lead having a tip end and a proximal end;

an exposed electrode tip included in said lead and positioned to extend away from the tip end of said lead;

a lead insertion device including holding means for releasably manually holding and pointing the tip end of said lead at a selected portion of a body, spaced from the tip end of said lead, and into which the electrode tip is to be implanted; and

resilient biasing means included in said lead and constructed and oriented to normally resist movement of the proximal end of said lead away from the holding means;

said biasing means acting to store potential energy when the proximal end of said lead is moved away from the holding means and held so as to stress the biasing means, and then to impart sufficient projectile momentum to the tip end of said lead, when the proximal end of the biasing means is released from being held in its stressed position, to cause the electrode tip to be projected against and to penetrate a surface of a heart, thereby embedding the electrode tip in the heart; and

handle means operatively associated with the biasing member for manually selectively moving the proximal end of the biasing member in an axial direction away from the holding means.

18. The invention of claim 17 wherein the means for manually holding and pointing the tip end of the lead comprises a tubular structure disposed around the lead.

19. The invention of claim 18 wherein a portion of the lead is resiliently elongatable and the biasing member comprises a coil spring included in the lead and normally oriented to resist resilient elongation of the lead.

20. The invention of claim 19 wherein the lead further comprises a flange adjacent the tip end of the lead and the holding means comprises a tubular structure disposed around the lead such that the flange is positioned to normally bear against the tubular structure when the coil spring is elongated by the handle means.

21. The invention of claim 17 wherein the electrode tip comprises a helical screw-in electrode tip and the biasing member is adapted to impart an angular momentum to the tip, which angular momentum tends to screw the screw-in electrode tip into the heart.

22. The invention of claim 17 wherein the electrode tip comprises a screw-in electrode tip and the lead insertion device comprises key means for locking the screw-in electrode tip against rotation with respect to the lead insertion device.

23. A cardiac lead comprising:

an electrode tip;

an elongatable coil spring electrically connected to the tip to form an electrical conductor extending away from the tip;

an elongatable insulating sheath disposed around the coil spring;

said coil spring and sheath cooperating to form an elongatable lead having a spring constant within a selected range, such that the lead can be selectively manually manipulated to cause the coil spring to impart a momentum to the tip sufficient to embed the tip in a heart.

24. The invention of claim 23 further comprising a tubular tip shield positioned removably around the insulating sheath and the electrode tip, said tip shield defining a plurality of flexible segments having a rest, closed position in which the segments substantially surround the electrode tip, and an open position in which the segments expose the electrode tip such that the lead can be passed through a blood vessel with the segments in the closed position, thereby substantially preventing the electrode tip from snagging on the blood vessel, and the tip shield can then be selectively withdrawn, thereby moving the segments to expose the electrode tip.

28. The invention of claim 23 or 25 wherein the electrode tip comprises a screw-in electrode tip.

29. The invention of claim 23 or 25 wherein the lead further comprises a transverse attachment flange secured to the coil spring and adjacent the electrode tip such that the electrode tip extends axially beyond the most distal surface of the flange.

30. The invention of claim 29 wherein the attachment flange includes a plurality of elongated prongs positioned on the flange space radially outwardly of the electrode tip and adapted to penetrate and mechanically engage the heart, thereby securing the flange to the heart.

31. The invention of claim 30 wherein each of the prongs extends, from its connection to the flange, radially spirally outwardly away from the electrode tip.

25. A cardiac lead assembly comprising:

an electrode tip;

an elongatable coil spring electrically connected to the tip to form an electrical conductor extending away from the tip;

an elongatable insulating sheath disposed around the coil spring;

a tubular lead insertion device slidably disposed around the elongatable sheath;

said coil spring and sheath cooperating to form an elongatable lead having a spring constant within a selected range, such that the lead can be selectively manually stretched axially against the insertion device and then released to cause the coil spring to impart a momentum to the tip sufficient to embed the tip in a heart.

26. The invention of claim 25 wherein the electrode tip comprises a screw-in electrode tip, and the lead further includes means for locking the screw-in electrode tip against rotation with respect to the lead insertion device.

27. The invention of claim 25 further comprising a tubular tip shield positioned removably around the lead insertion device and the electrode tip, said tip shield defining a plurality of flexible segments having a rest, closed position in which the segments substantially surround the electrode tip in an open position in which the segments expose the electrode tip such that the lead can be passed through a blood vessel with the segments in the closed position, thereby substantially preventing the electrode tip from snagging on the blood vessel, and the tip shield can then be withdrawn, thereby moving the segments to expose the electrode tip.

32. A cardiac lead comprising:

a screw-in electrode tip;

a flexible conductor connected to the electrode tip to extend away from the tip;

a flexible torque transmitting structure disposed around the flexible conductor, said structure comprising;

a first plurality of flexible filaments disposed in a helical pattern around the flexible conductor, each of said first plurality of flexible filaments defining respective proximal and distal ends;

a second plurality of flexible filaments disposed in a helical pattern around the flexible conductor, each of the second plurality of flexible filaments defining respective proximal and distal ends, the helical pattern of the first plurality of flexible filaments being reversed with respect to the helical pattern of the second plurality of flexible filaments such that the first plurality of flexible filaments repeatedly crosses the second plurality of flexible filaments; and

means for locking the electrode tip against rotation with respect to the distal ends of the first and second pluralities of flexible filaments.

33. The invention of claim 32 further comprising a flexible insulator sheath disposed over the torque transmitting structure.

34. The invention of claim 32 wherein the first and second pluralities of flexible filaments are included in a braided cable.

35. The invention of claim 34 wherein the flexible filaments are formed of a metal.

36. In a method for attaching an elongated electrical lead to a portion of a living body, such as the heart, where the electrical lead is an elongated flexible body having a proximal end and a distal end, with portions of the flexible body defined by coil spring means that serves as a flexible, but shape sustaining, electrical lead body, and which includes an exposed, spread coil, helical electrode tip segment at the lead'"'"'s distal end, said electrode tip segment being spaced by a transverse rigidifying flange from the flexible, shape sustaining electrical lead body, the spread coil tip being adapted to effect a screw-in of the electrode tip into a portion of a living body;

and wherein a portion of the elongated lead body is surrounded by tubular handle means which provides means for holding and pointing the lead'"'"'s distal end in alignment with, and closely spaced from, that portion of the living body wall which is to have the spread coil helical electrode tip screwed thereinto;

the improvement in the method comprising, in combination;

gaining access to a selected surfact of the living body that is to receive the screw-in electrode tip;

holding the handle means while aiming the screw-in electrode tip toward the selected surface of the living body to be pierced by the electrode tip;

using manually graspable means to elongate a portion of the coil spring that extends between said transverse rigidifying flange and the proximal end of the elongated lead body, to develop a projecting, restoring, force within the elongated lead body;

and suddenly releasing the elongated coil spring to cause the developed projecting force to operate to accelerate the exposed spread coil, helical electrode tip, toward the selected living body wall portion and to effect penetration of said selected wall portion of the living body, and embedding at least a portion of the exposed spread coil electrode tip in said selected wall portion of the living body.

37. The improved method as in claim 36 wherein the portion of the coil spring that is elongated by the manually graspable means is also twisted about the longitudinal axis of the coil spring to also potentialize an angular restoring force in the coil spring, so that, upon release of the manually graspable means, the screw-in electrode tip has imparted thereto a helical acceleration, having both an axial component and an angular component, which operates to cause the screw-in electrical tip to be projected with both angular and axial momentum that causes the screw-in electrical tip to screw itself into the selected area of the living body.

38. A means for implanting a cardiac lead assembly comprising, in combination:

an elongated, electrically conductive, resilient and axially extensible cardiac lead member having a proximal end and a distal end;

transverse flange means secured to said elongated member between its ends and adjacent to, but not at, the distal end of said elongated electrically conductive member;

means electrically isolating the exterior axial length of said conductive, resilient member, from adjacent its proximal end to said transverse flange means, and also electrically isolating all surfaces of the transverse flange, from inadvertently delivering electrical energy therefrom to the surrounding environment;

a portion of the elongated, electrically conductive, resilient member extending distally past the isolated transverse flange means to provide an exposed, electrically conductive, implantable electrode tip adapted to be implanted in cardiac tissue;

an annular attachment disc located on the distal side of the transverse flange means, positioned to surround and be spaced from said implantable electrode tip, and being electrically isolated from all portions of the cardiac lead, the axial length of the implantable electrode tip being greater than the axial length of said annular attachment disc;

and implanting means for the cardiac lead assembly comprising an elongated tubular insertion device having proximal and distal ends and being located between the transverse flange means and the proximal end of the axially extensible lead member, and with said elongated electrically isolated member slidably extending axially therethrough, with the proximal end of the cardiac lead projecting forwardly of the insertion device, and with the distal end of the insertion device being adapted to, and being of a size to, abut the electrically isolated transverse flange;

by means between the insertion device and transverse flange for separable interengagement for preventing relative rotation between the cardiac lead and the insertion device;

a handle means, carried on a portion of the resilient and axially extensible conductive member that projects toward the proximal end of the cardiac lead and beyond the proximal end of the tubular insertion device, for manually axially stretching, and also providing for rotatably twisting, the conductive member to store resilient forces therein, when the insertion device is held abutting, and keyed to, the transverse flange; and

the release of the stretched and/or rotated handle means being operative to project the implantable electrode tip in a distal direction away from the manually held insertion device.