# US 2008/0077215 A1 · Self-sealing insulation employed on a catheter or lead > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2008/0077215 A1 - Document ID: US20080077215A1 - Status: Published application - Kind: A1 - Application number: 11/946,453 - Filed: 2007-11-28 - Published: 2008-03-27 - Earliest claimed: 2005-08-17 - Assignees: Pacesetter, Inc. - Inventors: Yougandh Chitre; Cheuk Tang - Web page: https://patentgrep.com/patent/US20080077215A1 ## CPC - A61N 1/056: {Transvascular endocardial electrode systems} - A61N 1/05: for implantation or insertion into the body, e.g. heart electrode (A61N1/06 takes precedence) - A61N 1/057: {Anchoring means; Means for fixing the head inside the heart} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract An implantable electrical medical lead for a pulse generator includes a distal electrode, a connector for electrical connection with the pulse generator, an electrical conductor within the lead extending between the connector and the distal electrode, and an insulating sheath of flexible resilient material normally covering the electrical conductor having self sealing properties to re-insulate the electrical conductor in the event a rupture of the sheath should occur which exposes the electrical conductor. The insulating sheath includes an outer insulative layer, an inner insulative layer, and an intermediate plasticized layer to seal any occurring rupture in the insulating sheath and re-insulate the electrical conductor which has been exposed. ## Claims ### Claim 1 An implantable electrical medical lead extending between proximal and distal ends for use with a pulse generator to be implanted within a human body, the lead comprising: a distal electrode; a connector providing an electrical connection with the pulse generator; an electrical conductor within the lead extending between a proximal end for attachment with the connector and a distal end for attachment to the distal electrode; and an insulating sheath of flexible resilient material normally covering the electrical conductor and extending from the proximal end to the distal end and having self sealing properties to re-insulate the electrical conductor in the event of an abrasion of the sheath; wherein the insulating sheath includes: an outer insulative layer; an inner insulative layer; and a plasticized layer intermediate the outer insulative layer and the inner insulative layer to seal any occurring rupture in the insulating sheath and re-insulate the electrical conductor which has been exposed. ### Claim 2 (depends on 1) An implantable electrical medical lead as set forth in claim 1 wherein the material of the plasticized layer is a chemically softened silicone, polyurethane, or combination thereof. ### Claim 3 (depends on 1) An implantable electrical medical lead as set forth in claim 1 wherein the outer insulative layer has a thickness in the range of about 0.003 inches to about 0.010 inches; wherein the inner insulative layer has a thickness in the range of about 0.001 inches to about 0.005 inches; and wherein the plasticizer layer has a thickness in the range of about 0.0005 inches to about 0.0050 inches. ### Claim 4 (depends on 1) An implantable electrical medical lead as set forth in claim 1 wherein the outer insulative layer of the insulating sheath is composed of material selected from the group consisting of silicone, polyurethane, or a combination thereof; wherein the inner insulative layer of the insulating sheath is composed of material selected from the group consisting of fluorinated polymer, silicone, polyurethane, or a combination thereof; and wherein the material of the plasticized layer is a chemically softened silicone, polyurethane, or combination thereof. ### Claim 5 A method of sealing an implantable electrical medical lead, the integrity of which may be compromised, the lead extending between a proximal end for attachment with a connector for providing an electrical connection with the pulse generator and a distal end for attachment to the distal electrode, the method comprising: (a) with an insulating sheath of flexible resilient material, covering the electrical conductor extending from the proximal end to the distal end; (b) providing the insulating sheath with self sealing properties to re-insulate the electrical conductor in the event a rupture of the sheath should occur which exposes the electrical conductor, the insulating sheath being a polymeric material; and (c) forming the insulative sheath with an outer insulative layer, an inner insulative layer, and a plasticized layer intermediate the outer insulative layer and the inner insulative layer to re-insulate the electrical conductor in the event a rupture of the sheath should occur which exposes the electrical conductor. ### Claim 6 (depends on 5) The method as set forth in claim 5 wherein the material of the plasticized layer is a chemically softened silicone, polyurethane, or combination thereof. ### Claim 7 (depends on 5) The method as set forth in claim 5 wherein the outer insulative layer has a thickness in the range of about 0.003 inches to about 0.010 inches; wherein the inner insulative layer has a thickness in the range of about 0.001 inches to about 0.005 inches; and wherein the plasticizer layer has a thickness in the range of about 0.0005 inches to about 0.0050 inches; ### Claim 8 (depends on 5) The method as set forth in claim 5 wherein the outer insulative layer of the insulating sheath is composed of material selected from the group consisting of silicone, polyurethane, or a combination thereof; wherein the inner insulative layer of the insulating sheath is composed of material selected from the group consisting of fluorinated polymer, silicone, polyurethane, or a combination thereof; and wherein the material of the plasticized layer is a chemically softened silicone, polyurethane, or combination thereof. ### Claim 9 An implantable electrical medical lead extending between proximal and distal ends for use with a pulse generator to be implanted within a human body, the lead comprising: at least one electrode; a connector configured to provide an electrical connection with the pulse generator; an electrical conductor within the lead extending between a proximal end attached to the connector and a distal end attached to the at least one electrode; and an insulating sheath of flexible resilient material normally covering the electrical conductor and extending from the proximal end to the distal end and having self sealing properties to re-insulate the electrical conductor in the event of an abrasion of the sheath; wherein the insulating sheath includes: an outer insulative layer; an inner insulative layer; and a plasticized layer intermediate the outer insulative layer and the inner insulative layer to seal any occurring rupture in the insulating sheath and re-insulate the electrical conductor which has been exposed. ### Claim 10 (depends on 9) An implantable electrical medical lead as set forth in claim 9 wherein the material of the plasticized layer is a chemically softened silicone, polyurethane, or combination thereof. ### Claim 11 (depends on 9) An implantable electrical medical lead as set forth in claim 9 wherein the outer insulative layer has a thickness in the range of about 0.003 inches to about 0.010 inches; wherein the inner insulative layer has a thickness in the range of about 0.001 inches to about 0.005 inches; and wherein the plasticizer layer has a thickness in the range of about 0.0005 inches to about 0.0050 inches; ### Claim 12 (depends on 9) An implantable electrical medical lead as set forth in claim 9 wherein the outer insulative layer of the insulating sheath is composed of material selected from the group consisting of silicone, polyurethane, or a combination thereof; wherein the inner insulative layer of the insulating sheath is composed of material selected from the group consisting of fluorinated polymer, silicone, polyurethane, or a combination thereof; and wherein the material of the plasticized layer is a chemically softened silicone, polyurethane, or combination thereof.