Process of Manufacturing a Medical Use Electrical Lead

• US 20100036376A1
• Filed: 06/10/2005
• Published: 02/11/2010
• Est. Priority Date: 08/05/2004
• Status: Active Grant

• Current Assignee: Cathrx Ltd
• Original Assignee: Cathrx Ltd
• Inventors: Chong, Evan K., Booth, Norman, Anderson, Neil L.
• Granted Patent: US 8,286,338 B2
• Time in Patent Office: Days
• US Class Current: 606/41
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/49156 with selective destruction of conductive paths
• CPC Class Codes: Y10T 29/49162 by using wire as conductive path
• CPC Class Codes: Y10T 29/49224 with coating

Abstract

A process for manufacturing an electrical lead (10) having one or more electrodes (11) includes providing an elongate member (14) having at least one polymeric region and further having at least one electrical conductor (13) that extends along at least a part of a length of the elongate member (14) and that is contained in a wall of the elongate member. A length of the at least one electrical conductor (13) is accessed at the at least one polymeric region (34). An electrically conductive adhesive (15) is applied to the length of the at least one electrical conductor (13) that has been accessed.

Claims

1. A process for manufacturing a medical use electrical lead having one or more electrodes, the process including:

providing an elongate member having at least one polymeric region and further having at least one electrical conductor that extends along at least a part of a length of the elongate member and that is contained in a wall of the elongate member;

accessing a length of the at least one electrical conductor at the at least one polymeric region; and

;

applying an electrically conductive adhesive to the length of the at least one electrical conductor that has been accessed.

2. The process of claim 1 in which the electrically conductive adhesive comprises a silver filled epoxy.

3. The process of claim 2 in which at least some of the silver particles of the silver filled epoxy are coated with platinum or palladium.

4. The process of claim 1 which includes applying at least one electrically conductive material to the electrically conductive adhesive.

5. The process of claim 1 which includes overlaying the electrically conductive adhesive with a metal including platinum.

6. The process of claim 4 which includes overlaying the electrically conductive material with a metal including platinum.

7. The process of claim 1 in which the elongate member includes a plurality of electrical conductors and in which the process includes accessing a length of each of a plurality of the electrical conductors at circumferentially spaced intervals about the elongate member and applying a pad of the electrically conductive adhesive to the accessed length of each electrical conductor.

8. The process of claim 7 which includes applying a layer of at least one electrically conductive material to each pad of electrically conductive adhesive.

9. The process of claim 7 which includes overlaying each pad of electrically conductive adhesive with a metal layer including platinum or palladium.

10. The process of claim 9 in which the pads of electrically conductive adhesive are arranged in longitudinally aligned relationship about the circumference of the elongate member and in which the process includes applying the metal layer about the circumference of the elongate member as a continuous layer and, thereafter, separating the layer into a plurality of electrically isolated segments arranged at circumferentially spaced intervals to form a plurality of discrete electrodes arranged about the circumference of the elongate member.

11. The process of claim 6 which includes applying the metal including platinum by mounting a ring over the elongate member and securing the ring in position.

12. The process of claim 1 which includes isolating an electrical contact of the electrical lead from said one or more electrodes by:

accessing the electrical contact;

applying an electrically conductive adhesive to the first electrical contact; and

electrochemically treating the electrically conductive adhesive such that a portion of the electrically conductive adhesive is converted to an electrically non-conductive portion.

13. The process of claim 12 in which electrochemically treating the electrically conductive material comprises passing a current through the electrical contact in an ionic environment.

14. The process of claim 13 in which the ionic environment comprises a saline (NaCl) solution to convert a metal in the electrically conductive adhesive electrochemically to a metal chloride.

15. The process claim 12 in which the electrical contact is a contact of a thermocouple junction.

47. The process of claim 10 which includes applying the metal including platinum by mounting a ring over the elongate member and securing the ring in position.

16. A process of electrically isolating a first electrical contact of a medical use electrical lead from a second electrical contact of the electrical lead, the process including:

accessing the first electrical contact;

applying an electrically conductive adhesive to the first electrical contact; and

electrochemically treating the electrically conductive adhesive such that a portion of the electrically conductive adhesive is converted to an electrically non-conductive portion.

17. The process of claim 16 in which the electrochemical treatment comprises the step of passing a current through the electrical contact in an ionic environment.

18. The process of claim 17 in which the ionic environment comprises a saline (NaCl) solution to convert a metal in the electrically conductive adhesive electrochemically to a metal chloride.

19. The process of claim 16 in which the first electrical contact comprises a temperature sensing member.

20. The process of claim 16 in which the second electrical contact comprises an energy transmitting electrode.

21. The process of claim 20 in which the temperature sensing member comprises a thermocouple, the thermocouple having a first wire made of copper and a second wire made of Constantan.

22. A process of manufacturing a medical use electrical lead, the process including:

providing an elongate member having a proximal end and a distal end, at least one electrical conductor contained in the elongate member and extending from the proximal end towards the distal end of the elongate member, the at least one electrical conductor terminating in electrical connection with an electrically conductive zone arranged externally of the elongate member;

cutting the elongate member distally of the electrically conductive zone;

forming a non-conductive termination distally of the electrically conductive zone; and

applying a conductive material over the electrically conductive zone and the termination to form an end electrode of the electrical lead.

24. The process of claim 22 which includes applying the termination in a liquid state.

25. The process of claim 24 which includes applying the termination in two stages, a first layer being applied to seal the distal end of the elongate member and a second layer being applied and shaped to provide a desired shape to the end electrode.

26. The process of claim 22 which includes applying a solid termination to the distal end of the elongate member.

27. The process of claim 22 which includes applying the electrically conductive material in two stages.

28. The process of claim 27 which includes applying a first layer to the electrically non-conductive termination and to the electrically conductive zone bridging the electrically conductive zone and the termination.

29. The process of claim 28 which includes overlaying the first layer with a conductive, biocompatible material.

23. A process of manufacturing a medical use electrical lead, the process including:

providing an elongate member having a proximal end and a distal end, the elongate member having one or more polymeric regions and further having a plurality of electrical conductors that extend along at least a part of a length of the elongate member towards the distal end of the elongate member, the electrical conductors being contained within a wall of the elongate member;

in respect of each of at least some of the electrical conductors, forming an electrically conductive zone in electrical contact with its associated electrical conductor by;

accessing a length of each of the at least some electrical conductors through the polymeric region of the elongate member and applying an electrically conductive adhesive to each accessed electrical conductor;

applying conductive material at an access point associated with each electrical conductor to form a plurality of longitudinally spaced electrically conductive zones along the length of the elongate member;

cutting the elongate member distally of one of the electrically conductive zones;

applying an electrically non-conductive termination distally of the one electrically conductive zone; and

applying an electrically conductive material to bridge the electrically conductive zone and the termination to form an end electrode of the elongate member.

48. The process of claim 23 which includes applying the termination in a liquid state.

49. The process of claim 48 which includes applying the termination in two stages, a first layer being applied to seal the distal end of the elongate member and a second layer being applied and shaped to provide a desired shape to the end electrode.

50. The process of claim 23 which includes applying a solid termination to the distal end of the elongate member.

51. The process of claim 23 which includes applying the electrically conductive material in two stages.

52. The process of claim 51 which includes applying a first layer to the electrically non-conductive termination and to the electrically conductive zone bridging the electrically conductive zone and the termination.

53. The process of claim 52 which includes overlaying the first layer with a conductive, biocompatible material.

30. A medical use electrical lead which includes:

an elongate member having a proximal end and a distal end, at least one electrical conductor contained in the elongate member and extending from the proximal end towards the distal end of the elongate member, the at least one electrical conductor terminating in electrical connection with an electrically conductive zone arranged externally of the elongate member;

a non-conductive termination arranged distally of the electrically conductive zone and at a distal end of the elongate member; and

at least one layer of an electrically conductive material bridging the electrically conductive zone and the non-conductive termination to form an end electrode of the electrically conducive member.

31. The lead of claim 30 in which the termination is made from a non-conductive material including a resin.

32. The lead of claim 31 in which the termination is a synthetic resin.

33. The lead of claim 30 in which the termination is a solid element which is adhesively secured to the distal end of the elongate member both to seal the end and to form a desired shape for the end electrode.

34. A process of manufacturing a medical use electrical lead, the process including:

providing an elongate member having a proximal end and a distal end, at least one electrical conductor contained in the elongate member and extending from the proximal end towards the distal end of the elongate member, the at least one electrical conductor terminating in electrical connection with an electrically conductive zone arranged externally of the elongate member;

forming an access point in the elongate member to provide access to the at least one electrical conductor;

applying a radio opaque material to a region of the elongate member longitudinally in register with the access point but out of electrical contact with the access point; and

forming the electrically conductive zone by applying at least one layer of an electrically conductive material about the elongate member to be in electrical contact with the conductor through the access point and to overlie the radio opaque material.

35. The process of claim 34 which includes applying the radio opaque material as a layer to an external surface of the elongate member to form a cuff about the elongate member.

36. The process of claim 35 which includes positioning the cuff in a diametrically opposed position to the access point on the elongate member.

37. The process of claim 36 which includes applying the layer of electrically conductive material over the cuff, the layer of electrically conductive material comprising a first conductive layer overlaid with a second, biocompatible, electrically conductive material layer.

38. The process of claim 34 which includes inserting the radio opaque material into a recess formed in the elongate member, the recess being formed in a region of the elongate member diametrically opposed to the access point.

39. A medical use electrical lead which includes:

an elongate member having a proximal end and a distal end, at least one electrical conductor contained in the elongate member and extending from the proximal end towards the distal end of the elongate member;

an access point formed at a predetermined location in a wall of the elongate member to provide access to the electrical conductor;

a zone of radio opaque material carried by the elongate member in a region of the elongate member longitudinally in alignment with the access point but circumferentially spaced from the access point; and

at least one layer of an electrically conductive material carried at the predetermined location of the elongate member to provide electrical contact with the electrical conductor through the access point and to overlie the radio opaque material.

40. The lead of claim 39 in which the access point is in the form of a slit arranged transversely in a wall of the elongate member, the slit following the direction of winding of the electrical conductors.

41. The lead of claim 39 in which radio opaque material comprises approximately 70 to 80% non-conductive material and about 20 to 30% of adhesive material.

42. The lead of claim 41 in which the adhesive material comprises an epoxy.

43. The lead of claim 41 in which the radio opaque material is applied as a layer about a part of the circumference of the elongate member.

44. The lead of claim 43 in which the epoxy of the adhesive material of the radio opaque material is matched to that of the layer of the electrically conductive material.

45. The lead of claim 42 in which the radio opaque material is contained within a;

recess in the elongate member, the recess being arranged in a diametrically opposed position relative to the access point.

46. The lead of claim 45 in which the epoxy of the radio opaque material is selected to be the same as that used in filling the access point.