Method of manufacturing an mri compatible conductive lead body

• US 8,834,657 B2
• Filed: 08/19/2011
• Issued: 09/16/2014
• Est. Priority Date: 08/20/2010
• Status: Expired due to Fees

• Current Assignee: Kenergy, Inc.
• Original Assignee: Kenergy, Inc.
• Inventors: Claude, Timothy J., Bulkes, Cherik T., Norby, Mary K.
• Primary Examiner(s): Orlando, Michael
• Assistant Examiner(s): DULKO, MARTA S
• Application Number:
  US13/199,097
• Publication Number:
  US 20120043011A1
• Time in Patent Office: 1,124 Days
• Field of Search: 156/173
• US Class Current: 156/172
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: B29C 53/32 Coiling B29C53/56 takes precedence
• CPC Class Codes: B29C 61/006 the force created by the liberation of the internal stresses being used for compression moulding or for pressing preformed material
• CPC Class Codes: B29D 23/001 Pipes; Pipe joints pleated hoses B29D23/18
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

Abstract

A method of manufacturing an implantable electrical lead body MRI used in such applications as cardiac pacing, electrical nerve stimulation and intracardiac defibrillation applications that is biocompatible upon implantation in an animal and compatible with a magnetic resonance imaging scanner for the purpose of diagnostic quality imaging is disclosed. The method involves a relatively rigid first substrate layer, a conductive coil layer being precisely placed over the first substrate layer, a relatively soft second substrate layer over the conductive coil layer and a relatively rigid third substrate layer over the second substrate layer.

Claims

1. A method of manufacturing an implantable electrical lead body that is MRI compatible for the purpose of diagnostic quality imaging, comprising the steps of:

a. providing a mandrel defining a first end, a second end and an outer diameter;

b. applying a first substrate layer over the mandrel;

c. reflowing the first substrate layer to conform closely to the mandrel;

d. winding at least one conductive coil layer around the outer surface of the first substrate layer, wherein the conductive coil layer as a helix pitch and diameter;

e. securing the conductive coil layer to the mandrel at least at the first end and the second end;

f. applying a second substrate layer over the first substrate layer and the conductive coil layer;

g. reflowing the second substrate layer to fuse with the first substrate layer and encapsulate the conductive coil layer, permanently securing the conductive coil layer to the lead body and preserving the helix pitch and diameter;

h. applying a third substrate layer over the second substrate layer;

i. reflowing the third substrate layer to fuse with the second substrate layer;

j. removing the lead body from the mandrel; and

k. trimming the lead body to expose the conductive coil layer, allowing the lead body to be capable of electrical communication.

2. The method of claim 1 wherein the first substrate layer and the third substrate layers have a similar flexibility.

3. The method of claim 1 wherein the second substrate layer is a softer material than the first substrate layer and the third substrate layer.

4. The method of claim 3 wherein the first substrate layer and third substrate layer are made of a 55D polyurethane material.

5. The method of claim 3 wherein the second substrate layer is made from an 80A polyurethane material.

6. The method of claim 1 wherein reflowing the first, second and third substrate layers progressively uses first, second and third lengths of heat shrink material over the first, second and third substrate layers followed by the application of sufficient amounts of heat for periods of time sufficient to cause the first, second and third lengths of heat shrink material to decrease in size and to reflow the respective first, second and third substrate layers.

7. The method of claim 1 wherein reflowing the first substrate layer uses a first length of heat shrink material over the mandrel followed by the application of a sufficient amount of heat for a period of time sufficient to cause the first length of heat shrink material to decrease in size and reflow the first substrate layer, reflowing the second substrate layer uses a second length of heat shrink material over the mandrel followed by the application of a sufficient amount of heat for a period of time sufficient to cause the second length heat shrink material to decrease in size and reflow the second substrate layer and reflowing the third substrate layer uses a third length of heat shrink material over the mandrel followed by the application of a sufficient amount of heat for a period of time sufficient to cause the third length of heat shrink material to decrease in size and reflow the third substrate layer.

8. The method of claim 1 wherein the first end of the mandrel is tapered.

22. The method of claim 1 wherein each step of applying a first substrate layer, applying a second substrate layer, and applying a third substrate layer results in the respective substrate layer extending proximate to first and second ends of the implantable electrical lead.

9. A method of manufacturing an implantable electrical lead body that is MRI compatible for the purpose of diagnostic quality imaging, comprising the steps of:

a. providing a mandrel defining a first end and a second end and an outer dimension substantially conforming to a desired inner dimension of a lumen defined by the lead body, the mandrel coated with a non-stick material;

b. placing a first set of blockers at the first and second end of the mandrel, the first set of blockers serving to prevent the migration of subsequently applied layers during the method;

c. applying a first substrate layer between the first set of blockers;

d. applying a first length of heat shrink material over the first substrate;

e. exposing the first length of heat shrink material to a sufficient amount of heat for a sufficient length of time to cause the first substrate layer to reflow, resulting in the first substrate layer conforming to the coated mandrel;

f. removing the first length of heat shrink material;

g. winding at least one conductive coil layer over the outer surface of the first substrate layer;

h. securing the conductive coil layer to the mandrel;

i. placing a second set of blockers at the first and second end of the lead body;

j. applying a second substrate layer between the second set of blockers;

k. applying a second length of heat shrink material over the second substrate;

l. exposing the second length of heat shrink material to a sufficient amount of heat for a sufficient length of time to cause the second substrate layer to reflow, resulting in the second substrate layer encapsulating the conducting coil layer and fusing with the first substrate layer;

m. removing the second length of heat shrink material;

n. applying a third substrate material over the uncompleted lead body;

o. applying a third length of heat shrink material over the third substrate;

p. exposing the third length of heat shrink material to a sufficient amount of heat for a sufficient length of time to cause the third substrate layer to reflow and bond with the second substrate layer;

q. removing the third length of heat shrink material;

r. loosening the blockers from the mandrel;

s. removing the lead body from the mandrel; and

t. removing the blockers to expose the conductive coil layer, allowing the lead body to be capable of electrical communication.

10. The method of claim 9 wherein the first substrate layer and the third substrate layers have a similar flexibility.

11. The method of claim 9 wherein the second substrate layer is a softer material than the first substrate layer and the third substrate layer.

12. The method of claim 11 wherein the first substrate layer and third substrate layer are a 55D polyurethane material.

13. The method of claim 11 wherein the second substrate layer is an 80A polyurethane material.

14. The method of claim 9 wherein the reflowed first substrate layer has a substantially similar outer dimension as the first set of blockers.

15. The method of claim 9 wherein the reflowed second substrate layer has a substantially similar outer dimension as the second set of blockers.

16. The method of claim 9 wherein a third set of blockers is placed on the lead body following winding of the conductive coil layer and before application of the third substrate layer.

17. The method of claim 9 wherein the first end of the mandrel is tapered.

23. The method of claim 9 wherein each step of applying a first substrate layer, applying a second substrate layer, and applying a third substrate layer results in the respective substrate layer extending proximate to first and second ends of the implantable electrical lead.

18. A method for fabricating an electrical lead for an implantable electronic medical device, said method comprising:

a. placing a first tube of a polymer over a mandrel;

b. placing a first heat shrinkable tubing over the mandrel and the first tube;

c. applying heat to shrink the first heat shrinkable tubing around the first tube and to reflow the first tube to conform to the mandrel;

d. removing the first heat shrinkable tubing from the first tube;

e. winding an electrical conductor in a longitudinal spiral around the first tube, thereby forming a conductive coil layer;

f. placing a second tube of a polymer over the mandrel, the first tube, and the conductive coil layer;

g. placing a second heat shrinkable tubing over the mandrel, the first tube, the conductive coil layer, and the second tube; and

h. applying heat to shrink the second heat shrinkable tubing around the second tube and reflow the second tube to fuse with the first tube and encapsulate the conductive coil layer.

19. The method as recited in claim 18 further comprising:

i. removing the second heat shrinkable tubing from around the second tube;

j. placing a third tube of a polymer over the mandrel, the first tube, the conductive coil layer, and the second tube;

k. placing a third heat shrinkable tubing over the mandrel, the first tube, the conductive coil layer, the second tube and the third tube; and

l. applying heat to reflow the third tube and shrink the third heat shrinkable tubing around the third tube.

20. The method as recited in claim 19 further comprising removing the third heat shrinkable tubing from around the third tube.

21. The method of claim 18 wherein each step of placing a first tube and placing a second tube results in the first and second tube extending proximate to first and second ends of the implantable electrical lead.