Self-sealing insulation employed on a catheter or lead

• US 7,353,066 B1
• Filed: 08/17/2005
• Issued: 04/01/2008
• Est. Priority Date: 08/17/2005
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Chitre, Yougandh, Tang, Cheuk
• Primary Examiner(s): Sykes; Angela D.
• Assistant Examiner(s): Dietrich; Joseph M
• Application Number:
  US11/206,448
• Time in Patent Office: 958 Days
• Field of Search: 607/116, 607/119, 607/122, 607/125, 600/372, 600/373, 600/374, 600/375, 600/377, 336/94, 336/96
• US Class Current: 607/116
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart

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. In one instance, the insulating sheath is of polymeric material embedded with a plurality of pellets, each pellet having a frangible shell containing a liquid sealing material that solidifies when the frangible shell is broken and thereby filling in any voids in the polymeric material. In another instance, 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

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 is of polymeric material embedded with a plurality of pellets, each pellet having a frangible shell containing a liquid sealing material that fills a rupture and solidifies when the frangible shell is broken;

wherein the flexible resilient material of the insulating sheath is selected from the group consisting of silicone or polyurethane or a combination thereof;

wherein the material of the shell of each pellet is at least one of a polycarbonate and a polyvinyl chloride; and

wherein the liquid sealing material in each pellet is a body (temperature) curable adhesive.

2. An implantable electrical medical lead as set forth in claim 1

wherein the plurality of the pellets occupy in the range of about 30% to about 70% of the volume of the insulating sheath.

3. An implantable electrical medical lead as set forth in claim 1

wherein the insulating sheath has a thickness in the range of about 0.003 inches to about 0.010 inches;

and

wherein each of the pellets has a transverse dimension in the range of about 0.0005 inches to about 0.0010 inches.

4. An implantable electrical medical lead as set forth in claim 1

wherein the plurality of the pellets occupy in the range of about 30% to about 70% of the volume of the insulating sheath;

wherein the insulating sheath has a thickness in the range of about 0.003 inches to about 0.010 inches; and

wherein each of the pellets has a transverse dimension in the range of about 0.0005 inches to about 0.0010 inches.

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 a pulse generator and a distal end for attachment to a distal electrode, the method comprising:

(a) with an insulating sheath of flexible resilient material, covering an electrical conductor extending from the proximal end to the distal end; and

(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;

wherein the insulating sheath is of polymeric material; and

including the step of;

(c) embedding the polymeric material of the insulating sheath with a plurality of pellets, each pellet having a frangible shell containing a liquid sealing material that fills a rupture and solidifies when the frangible shell is broken;

wherein the flexible resilient material of the insulating sheath is selected from the group consisting of silicone or polyurethane or a combination thereof;

wherein the shell of each pellet is a polycarbonate; and

wherein the liquid sealing material in each pellet is epoxy.

6. The method as set forth in claim 5

wherein the plurality of the pellets occupy in the range of about 30% to about 70% of the volume of the insulating sheath.

7. The method as set forth in claim 5

wherein the insulating sheath has a thickness in the range of about 0.003 inches to about 0.010 inches;

and

wherein each of the pellets has a transverse dimension in the range of about 0.0005 inches to about 0.0010 inches.

8. The method as set forth in claim 5

wherein the plurality of the pellets occupy in the range of about 30% to about 70% of the volume of the insulating sheath;

wherein the insulating sheath has a thickness in the range of about 0.003 inches to about 0.010 inches; and

wherein each of the pellets has a transverse dimension in the range of about 0.0005 inches to about 0.0010 inches.

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;

an insulating sheath of flexible resilient material normally covering the electrical conductor and extending from the proximal end to the distal end; and

a self-sealing member operative to re-insulate the electrical conductor in the event of an abrasion of the sheath;

wherein the insulating sheath is of polymeric material embedded with a plurality of pellets, each pellet having a frangible shell containing a liquid sealing material that fills a rupture and solidifies when the frangible shell is broken;

wherein the flexible resilient material of the insulating sheath is selected from the group consisting of silicone or polyurethane or a combination thereof;

wherein the material of the shell of each pellet is at least one of a polycarbonate and a polyvinyl chloride; and

wherein the liquid sealing material in each pellet is a body (temperature) curable adhesive.