Formable cardiac pacer lead and method of assembly and attachment to a body organ

Claim 2

A body implantable lead adapted to transmit electrical signals, said lead having an initial, substantially linear configuration, said lead comprising: (a) an electrically conductive electrode for being disposed in electrical contact with a body organ; (b) a flexible electrical conductor having a predetermined length and electrically coupled to said electrode; (c) first means coupled to said lead and actuatable in response to the application of heat and force for being shaped initially to impart to said lead a first, non-linear configuration to dispose said electrode in efficient contact with a desired portion of the body organ, said first means comprising a flexible, insulating material; and (d) second means for providing an electrically insulating, protective surface inert to body fluids and tissues and disposed about said lead, said insulating material having the property of being shaped at a temperature less than that temperature at which said second means is adversely affected.

Claim 3

A body implantable lead as claimed in claim 1, wherein said first means comprises an insulating layer disposed about said electrical conductor and made of a repeatably heat-deformable insulating material.

Claim 4

A body implantable lead as claimed in claim 1, wherein said insulating material of said first means has the property of being heat-deformable at a temperature greater than body temperature.

Claim 5

A body implantable lead as claimed in claim 2, wherein said insulating material comprises polyethylene.

Claim 6

A body implantable lead as claimed in claim 2, wherein said insulating material comprises polyurethane.

Claim 7

A body implantable lead as claimed in claim 2, wherein said insulating material comprises polypropylene.

Claim 8

A cardiac pacer lead adapted for applying electrical stimulation from a cardiac pacer to the ventricular and atrial portions of a patient's heart, said pacer lead having a first, substantially linear configuration, said lead comprising: (a) first and second electrically conductive contacts for being coupled to the ventricle and atrium stimulating portions of the patient's cardiac pacer; (b) first and second electrically conductive electrodes for being disposed, respectively, in efficient electrical contact with the ventricular and atrial portions of the patient's heart; (c) first and second electrical conductors each having leading and trailing end portions and affixed to and electrically coupled, respectively, to said first contact and electrode, and said second contact and electrode; (d) first means comprising a covering disposed about said first and second electrical connectors and made of a first flexible, shapeable insulating material and actuable in response to the application of heat of a given temperature for being disposed to a second configuration to impart to said pacer lead a selected, corresponding configuration whereby a portion of said pacer lead corresponding to said leading portion of said conductors is offset with respect to the remaining portion thereof so that said second electrode may be offset with respect to the trailing portion thereof, maintaining said second electrode in efficient electrical contact with the atrial portion of the patient's heart; and (e) second means for providing a protective surface about said pacer lead and made of a second insulating material resistant to corrosion by the patient's body fluids, said temperature being less than that temperature at which said second insulating material is degraded.

Claim 9

A cardiac pacer lead adapted for applying electrical stimulation from a cardiac pacer to the ventricular and atrial portions of a patient's heart, said pacer lead having a first, substantially linear configuration, said lead comprising: (a) first and second electrically conductive contacts for being coupled to the ventricle and atrium stimulating portions of the patient's cardiac pacer; (b) first and second electrically conductive electrodes for being disposed, respectively, in efficient electrical contact with the ventricular and atrial portions of the patient's heart; (c) first and second electrical conductors each having leading and trailing end portions and affixed to and electrically coupled, respectively, to said first contact and electrode, and said second contact and electrode; (d) first means comprising a covering disposed about said first and second electrical connectors and made of a first flexible, shapeable insulating material and actuable in response to the application of heat of a given temperature for being disposed to a second configuration to impart to said pacer lead a selected, corresponding configuration whereby a portion of said pacer lead corresponding to said leading portion of said conductors is offset with respect to the remaining portion thereof so that said second electrode may be offset with respect to the trailing portion thereof, maintaining said second electrode in efficient electrical contact with the atrial portion of the patient's heart; and (e) second means for providing a protective surface about said pacer lead and made of a second insulating material resistant to corrosion by the patient's body fluids, said temperature being less than that temperature at which said second insulating material is degraded.

Claim 10

The cardiac pacer lead as claimed in claim 7, wherein said first means comprises a covering disposed about said first and second electrical connectors and made of a flexible, shapeable insulating material.

Claim 11

The cardiac pacer lead as claimed in claim 8, wherein said insulating material of said second means comprises a silicone rubber.

Claim 12

The cardiac pacer lead as claimed in claim 7, wherein said leading portion of said pacer lead is configured in a substantially circular configuration, whereby said second electrode is displaced from said trailing portion of said pacer lead.

Claim 13

The cardiac pacer lead as claimed in claim 7, wherein said pacer lead is configured in a substantially S-shaped configuration, whereby said second electrode is displaced from the direction of extent of said trailing portion of said pacer lead.

Claim 14

The combination of a body implantable lead adapted to transmit electrical signals, said lead having a first substantially linear configuration, and rigid means for maintaining said body implantable lead in said first linear configuration; said lead comprising: (a) an electrically conductive electrode for being disposed in an electrical contact with a body organ; (b) a flexible electrical conductor having a predetermined length and electrically coupled to said electrode; (c) first means coupled to said lead and actuatable in response to the application of heat and force for being shaped initially to impart to said lead a second, non-linear configuration to dispose said electrode in efficient contact with a desired portion of the body organ, said first means comprising a flexible, insulating material; (d) second means for providing an electrically insulating protective surface inert to body fluids and tissues and disposed about said lead; (e) said insulating material having the property of being shaped at a temperature less than that temperature at which said second means is adversely affected; and (f) third means for receiving said rigid means, whereby said lead is reformed from said second non-linear configuration to said first linear configuration to facilitate the insertion of said lead into the body.

Claim 15

The combination of a body implantable lead adapted to transmit electrical signals, said lead having a first substantially linear configuration, and rigid means for maintaining said body implantable lead in said first linear configuration; said lead comprising: (a) an electrically conductive electrode for being disposed in an electrical contact with a body organ; (b) a flexible electrical conductor having a predetermined length and electrically coupled to said electrode; (c) first means coupled to said lead and actuatable in response to the application of heat and force for being shaped initially to impart to said lead a second, non-linear configuration to dispose said electrode in efficient contact with a desired portion of the body organ, said first means comprising a flexible, insulating material; (d) second means for providing an electrically insulating protective surface inert to body fluids and tissues and disposed about said lead; (e) said insulating material having the property of being shaped at a temperature less than that temperature at which said second means is adversely affected; and (f) third means for receiving said rigid means, whereby said lead is reformed from said second non-linear configuration to said first linear configuration to facilitate the insertion of said lead into the body.

Claim 16

The combination as claimed in claim 12, wherein said third means defines an opening extending along substantially the entire length of said lead for receiving said elongated means.

Claim 19

The method as claimed in claim 14, wherein said lead comprises an opening for receiving straightening means, and said step of shaping and maintaining is effected by inserting said straightening means into said opening, and said reshaping step is effected by withdrawing said straightening means from said opening.

Claim 20

The method as claimed in claim 14, wherein the step of heating raises the lead temperature to a temperature which is in excess of body temperature.