Medical devices including polyisobutylene based polymers and derivatives thereof

• US 8,942,823 B2
• Filed: 01/31/2014
• Issued: 01/27/2015
• Est. Priority Date: 09/02/2009
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Desai, Shrojalkumar, Reddy, G. Shantanu
• Primary Examiner(s): Alter, Alyssa M
• Application Number:
  US14/170,200
• Publication Number:
  US 20140144580A1
• Time in Patent Office: 361 Days
• Field of Search: 607/116, 298/74
• US Class Current: 607/116
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: C08G 18/12 using two or more compounds having active hydrogen in the first polymerisation step
• CPC Class Codes: C08G 18/3206 aliphatic
• CPC Class Codes: C08G 18/4063 Mixtures of compounds of group C08G18/62 with other macromolecular compounds
• CPC Class Codes: C08G 18/4854 Polyethers containing oxyalkylene groups having four carbon atoms in the alkylene group
• CPC Class Codes: C08G 18/6204 Polymers of olefins unsaturated polymers of conjugated dienes C08G18/69
• CPC Class Codes: C08G 18/6705 Unsaturated polymers not provided for in the groups C08G18/671, C08G18/6795, C08G18/68 or C08G18/69
• CPC Class Codes: C08G 18/7671 containing only one alkylene bisphenyl group
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 29/49204 Contact or terminal manufacturing

Abstract

The present invention is directed to a medical electrical lead including an insulative lead body formed, at least in part, from a polyisobutylene urethane, urea or urethane/urea copolymer. In some applications, the lead body can include at least one outer tubular insulator and/or an inner elongated member formed from a polyisobutylene urethane, urea or urethane/urea copolymer. Portions of the lead body formed form the polyisobutylene urethane, urea or urethane/urea copolymer can be either extruded or molded.

Claims

1. A method of manufacturing an implantable medical lead comprising:

forming a lead body portion having a Shore hardness from about 30 A to about 75 D from a polymer material comprising a polyisobutylene urethane, urea or urethane/urea copolymer, wherein the copolymer comprises soft polymer segments and hard polymer segments in a weight ratio of from 50;

50 to 90;

10, wherein the soft polymer segments comprise a polyisobutylene segment and at least one additional polymer segment comprising a residue of;

a polyether diol, a fluorinated polyether diol, a fluoropolymer diol, a polyester diol, a polyacrylate diol, a polymethacrylate diol, a polysiloxane diol, a fluorinated polysiloxane diol, or a polycarbonate diol; and

associating the lead body portion with a conductor and an electrode connected to the conductor.

2. The method of claim 1 wherein the lead body portion is formed by extruding or injection molding the polymer material.

3. The method according to claim 1, wherein the polyisobutylene urethane, urea or urethane/urea copolymer comprises an unsaturated polyisobutylene segment.

4. The method according to claim 1, wherein the polyisobutylene urethane, urea or urethane/urea copolymer comprises a polyisobutylene segment formed from a saturated polyisobutylene diol having a number average molecular weight of between about 1000 and 5000.

5. The method according to claim 1, wherein the polyisobutylene urethane, urea or urethane/urea copolymer comprises a polytetramethylene oxide segment formed from a polytetramethylene oxide diol having a number average molecular weight of between about 500 and 3000.

6. The method according to claim 1, further comprising the step of combining the polyisobutylene urethane, urea or urethane/urea copolymer with at least one processing aid or stabilizer to form a mixture.

7. The method according to claim 6, further comprising the step of extruding the lead body portion from the mixture.

8. The method according to claim 6, wherein the stabilizer is a plasticizer or wax and wherein the stabilizer is an antioxidant or thermal stabilizer.

9. The method according to claim 1, wherein forming the lead body portion comprises forming a proximal region including a first shore hardness, a middle region comprising a second shore hardness and a distal region comprising a third shore hardness, wherein each of the first, second and third regions comprises the polyisobutylene urethane, urea or urethane/urea copolymer.

10. The method according to claim 1, wherein the proximal region comprises a first weight ratio of soft segments to hard segments in the polyisobutylene urethane, urea or urethane/urea copolymer, the middle region comprises a second weight ratio of soft segments to hard segments in the polyisobutylene urethane, urea or urethane/urea copolymer, and the distal region comprises a third weight ratio of soft segments to hard segments in the polyisobutylene urethane, urea or urethane/urea copolymer.

11. The method according to claim 1, wherein the forming step comprises electrospinning the polyisobutylene urethane, urea or urethane/urea copolymer.