Soluble covering for cardiac pacing electrode

• US 4,827,940 A
• Filed: 04/13/1987
• Issued: 05/09/1989
• Est. Priority Date: 04/13/1987
• Status: Expired due to Term

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Berglund, June M., Mayer, David W., Gilman, Byron L., Walgren, Susan M.
• Primary Examiner(s): Cohen, Lee S.
• Application Number:
  US07/037,684
• Time in Patent Office: 757 Days
• Field of Search: 128/784-786, 128/642, 128/419 P, 604/265
• US Class Current: 600/375
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/288 for foetal cardiography, e.g. scalp electrodes
• CPC Class Codes: A61B 5/29 for permanent or long-term implantation
• CPC Class Codes: A61B 5/4362 Assessing foetal parameters
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61N 1/0565 Electrode heads
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

A biocompatible covering, soluble in body fluids, surrounds the fixation helix of an implantable cardiac electrode as the electrode, and its adjoining lead, are inserted intravenously to a selected cardiac chamber. The covering size and shape are selected for protection of blood vessels and other body tissues during insertion, and for exposure of the fixation element shortly after its proper positioning. The covering may be applied to the fixation element by a dip coating process, or formed separately by casting or injection molding, for later attachment to the lead distal end using an adhesive.

Claims

1. An intravascular lead implantable inside a patient, including:

an electrode having a fixation element for effecting penetration into endocardial tissue at a selected location to secure said electrode at said selected location;

a flexible electrical conductor;

a flexible, biocompatible dielectric sheath surrounding said conductor along substantially the entire length thereof; and

a coupling means for electrically and mechanically joining said electrode to a distal end of said conductor, whereby the conductor and electrode transmit electrical signals between said selected location and a proximal end of said conductor; and

a biocompatible covering surrounding said fixation element for facilitating intravascular movement of said electrode, said covering soluble in body fluids, stable in an ambient environment, having a melting point of at least 60°

C., tending to maintain its structural integrity in an environment of bodily fluids at approximately body temperature, and having thickness selected to allow at least a predetermined minimum time for the intravascular insertion of said electrode and the positioning of said electrode at least proximate said selected location, before said covering dissolves sufficiently to expose said fixation element and permit said penetration, said covering consisting essentially of at least one of the following constituents;

mannitol;

dextrose;

sorbose;

sucrose;

sodium chloride;

potassium chloride; and

sodium carbonate.

2. The intravascular lead of claim 1 wherein:

said covering consists essentially of mannitol.

3. The intravascular lead of claim 1 wherein:

said covering consists of one of said constituents.

4. The intravascular lead of claim 1 wherein:

said covering comprises a preformed capsule with means forming a bore in said capsule for accommodating said fixation element, and means joining said capsule with respect to said electrode with said fixation element inside of said bore.

5. The intravascular lead of claim 4 wherein:

said joining means comprises an adhesive.

6. The intravascular lead of claim 4 wherein:

said fixation element is a helix, and said bore has a helical shape corresponding to the shape of said helix.

7. The intravascular lead of claim 1 wherein:

said electrode includes an electrically conductive and porous electrode portion proximally of said fixation element.

8. The intravascular lead of claim 7 wherein:

said covering overlies part of said porous electrode portion and leaves the remainder of said portion exposed.

9. An apparatus for facilitating intravascular insertion of a body implantable device, comprising:

a body implantable device, a fixation element at a distal end of said device, and a bicompatible, non-pyrogenic covering substantially surrounding said fixation element, said covering having a melting point of at least 60°

C., being stable in an ambient environment, soluble in body fluids, tending to maintain its structural integrity in an environment of bodily fluids at approximatley body temperature, and having a thickness selected to allow at least a predetermined time for the intravascular insertion of said distal end at least proximate to a selected location inside a body of a living animal, before said covering dissolves sufficiently to expose said fixation element to permit penetration of the fixation element into body tissue at said selected location, said covering consisting essentially of at least one of the following constituents;

mannitol;

dextrose;

sorbose;

asucrose;

sodium chloride;

sodium carbonate; and

potassium chloride.

10. The apparatus of claim 9 wherein:

said covering consists essentially of mannitol.

11. The apparatus of claim 9 wherein:

said covering consists essentially of one of said constituents.

12. The apparatus of claim 9 wherein:

said body implantable device comprises a cardiac pacing electrode.

13. The apparatus of claim 12 wherein:

said covering is formed by dip coating a material comprising said covering in liquid melt form onto said fixation element for solidifying in surrounding relation to said element.

14. The apparatus of claim 12 wherein:

said covering comprises a preformed capsule and means forming a bore in said capsule to accommodate said fixation element, said apparatus further including means for connecting said capsule with respect to said electrode with said fixation element contained in said bore.

15. The apparatus of claim 14 wherein:

said fixation element is a helix, and said bore has a helical shape corresponding to the shape of said helix.

16. The apparatus of claim 14 wherein:

said electrode includes a porous screen, and said capsule, when connected with respect to said electrode, overlies most of said screen, leaving the remainder of said screen exposed.

17. The apparatus of claim 12 wherein:

said electrode includes an electrically conductive and porous screen located proximally of said fixation element, and said electrode is selectively dip coated to cover said fixation element and a portion of said screen, leaving the remainder of said screen exposed.

18. An intravascular lead implantable inside a patient, including:

an electrode having a fixation element for effecting penetration into endocardial tissue at a selected location to secure said electrode at said selected location;

a flexible electrical conductor;

a flexible, biocompatible dielectric sheath surrounding said conductor along substantially the entire length thereof; and

a coupling means for electrically and mechanically joining said electrode to a distal end of said conductor, whereby the conductor and electrode transmit electrical signals between said selected location and a proximal end of said conductor; and

a biocompatible covering surrounding said fixation element for facilitating intravascular movement of said electrode, said covering soluble in body fluids, stable in an ambient environment, having a melting point of at least 60°

C., tending to maintain its structural integrity in an environment of bodily fluids at approximately body temperature, and having a thickness selected to allow at least a predetermined minimum time for the intravascular insertion of said electrode and the positioning of said electrode at least proximate said selected location, before said covering dissolves sufficiently to expose said fixation element and permit said penetration, wherein said covering is formed by dip coating said fixation element with a liquid melt of material comprising said covering.