EP0337035A1
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Soluble covering for cardiac pacing electrode
Assignee: Cardiac Pacemakers Inc
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Filing: 1988-12-15
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Granted: —
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Expires: 2008-12-15
Abstract
Abstract A biocompatible covering (30), soluble in body fluids, surrounds the fixation helix (28) of an implantable cardiac electrode as the electrode, and its adjoining lead (16), 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 (28) shortly after its proper positioning. The covering (30) may be applied to the fixation element (28) by a dip coating process, or formed separately by casting or injection molding, for later attachment to the lead (16) distal end using an adhesive.
Inventors
- 👤 David W. Mayer
- 👤 Byron L. Gilman
- 👤 Susan M. Walgren
- 👤 June M. Berglund
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-30 12:48
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/68; A61B5/6846; A61B5/6847; A61B5/6852; A61B5/24; A61B5/25; A61B5/279; A61B5/28; A61B5/283; A61B5/288; A61B5/29; A61B5/43; A61B5/4306; A61B5/4343; A61B5/4362; A61N; A61N1/00; A61N1/02; A61N1/04; A61N1/05; A61N1/056; A61N1/0565; A61N1/057; A61N1/0573
Claims Analysis
Total Claims: 14
Claim 1
Independent Claim
209 words
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 lead and 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 substantially of at least one of the following constituents: mannitol; dextrose; sorbose; sucrose; sodium chloride; potassium chloride; and sodium carbonate.
Claim 2
Dependent Claim
49 words
The apparatus or intravascular lead of Claim 1 2 or 3 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.
Claim 3
Dependent Claim
15 words
The apparatus or intravascular lead of Claim 4 wherein: said joining means comprises an adhesive.
Claim 4
Dependent Claim
29 words
The apparatus or 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.
Claim 5
Dependent Claim
24 words
The intravascular lead of Claim 2,3,4,5 or 6 wherein: said electrode includes an electrically conductive and porous electrode portion proximally of said fixation element.
Claim 6
Dependent Claim
24 words
The intravascular lead of Claim 7 wherein: said covering overlies part of said porous electrode portion and leaves the remainder of said portion exposed.
Claim 7
Independent Claim
153 words
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 biocompatible, 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 approximately 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 substantially of at least one of the following constituents: mannitol; dextrose; sorbose; sucrose; sodium chloride; sodium carbonate; and potassium chloride.
Claim 8
Dependent Claim
15 words
The apparatus of Claim 9 wherein: said body implantable device comprises a cardiac pacing electrode.
Claim 9
Independent Claim
35 words
The apparatus of any preceding Claim 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.
Claim 10
Dependent Claim
46 words
The apparatus of Claim 2 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.
Claim 11
Dependent Claim
162 words
A process for coating a fixation element of a body implantable electrode, including the steps of: (a) selecting a biocompatible, non-pyrogenic material soluble in bodily fluids and having a melting point substantially above normal body temperature, and heating said material to a temperature slightly above its melting point; (b) dipping a fixation element of a body implantable electrode into a solution of said material maintained at said temperature; (c) removing said fixation member, along with an initial portion of said material adhering to said fixation member, from said solution and permitting them to cool a sufficient time to allow said first portion to at least partially solidify; (d) dipping said fixation member and material portion, after said cooling, into said solution for a time sufficient to permit a subsequent portion of said material to adhere to said initial portion; and (e) removing said fixation member, initial portion and subsequent portion from said solution, and permitting them to cool to an ambient temperature.
Claim 12
Dependent Claim
33 words
The process of Claim 11 including the further steps of: repeating steps (d) and (e) until the combined thickness of said initial portion and all subsequent portions is at least a predetermined value.
Claim 13
Dependent Claim
87 words
The process of Claim 11 or 12 including the further steps of: providing means defining a cavity having a selected size and shape, and heating a wall forming said cavity to a preselected temperature at least as high as the melting point of said material; and with the combined thickness of said material portions being at least said predetermined value to form a tip larger than said cavity, momentarily inserting said tip into said cavity to melt excess material; and draining said excess material from said cavity.
Claim 14
Dependent Claim
204 words
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 approximatley 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.
References Cited (Backward Citations)
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