Implantable lead construction

• US 4,711,027 A
• Filed: 08/04/1986
• Issued: 12/08/1987
• Est. Priority Date: 12/15/1983
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Harris, Donald L.
• Primary Examiner(s): Goldberg, Howard N.
• Assistant Examiner(s): Arbes, Carl J.
• Application Number:
  US06/892,959
• Time in Patent Office: 491 Days
• Field of Search: 29/447, 29/857, 29/869, 29/868, 128/419 P, 128/419 D, 128/785, 128/788, 174/84 R
• US Class Current: 29/869
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: Y10T 29/49174 Assembling terminal to elongated conductor
• CPC Class Codes: Y10T 29/49195 with end-to-end orienting

Abstract

A method is provided for constructing a mechanically strong and fluid tight assembly of an electrode along the length of an implantable lead, such as those leads suitable for cardiac pacing and diagnosis and the like. In the preferred embodiment, a short annular sheath polymeric tube is closely positioned over a coiled insulated conductor, an electrode is positioned over the short annular sheath, and a section of the insulating sheath of the lead is positioned over a flange of the electrode and sealed to a shape that is substantially isodiametric with the electrode surface.

Claims

1. A method for constructing an implantable lead, comprising:

positioning a first section of flexible insulating polymeric sheath over a coiled conductor member having an insulator coating;

providing a short annular sheath over said coiled conductor member, said short annular sheath being radially recessed with respect to and axially extending beyond said first insulating sheath section;

uncoiling a length of said coiled conductor member and removing a portion of its insulator coating to form a free conductor length having an uninsulated portion;

wrapping at least a portion of said free conductor length generally around at least a portion of said short annular sheath;

engaging an electrode member into electrical communication with said uninsulated portion of said free conductor length;

butting together said electrode member and said first section of flexible insulating polymeric sheath until one axial face of said electrode member engages an axial face of said first section of insulating polymeric sheath; and

sliding a second section of flexible insulating polymeric sheath over said coiled conductor member and butting together said electrode member and said second section of flexible insulating polymeric sheath until another axial face of said electrode member engages an axial face of said second section of insulating polymeric sheath.

2. The method according to claim 1, wherein said coiled conductor member is a multifilar coil and a plurality of electrode members are provided, and wherein said method includes a plurality of said uncoiling and wrapping steps, followed by engaging each uninsulated portion of each free conductor length with one of said electrode members, and said butting and sliding steps are repeated to provide a structure wherein the electrode members are insulated from each other.

3. The method according to claim 1, further including circumferentially flaring an end portion of said second section of flexible insulating polymeric sheath in order to form a flared end portion thereof prior to said sliding step, and subsequent to said sliding step reforming said flared end portion so as to be substantially isodiametric with the remainder of said second section and with the surface of said electrode member.

4. The method according to claim 1, further including circumferentially flaring an end portion of said first section of flexible insulating polymeric sheath in order to form a flared end portion thereof prior to said positioning step, and subsequent to said butting step reforming said flared end portion so as to be substantially isodiametric with the remainder of said first section and with the surface of said electrode member.

5. The method according to claim 3, further including providing an axially extending flange of said electrode member, and forming at least one opening through said flange, whereby during said reforming step polymeric material from said second section of insulating sheath is joined with polymeric material from said radially recessed short annular sheath.

6. The method according to claim 4, further including providing an axially extending flange of said electrode member and forming at least one opening through said flange, whereby during said reforming step polymeric material from said first section of insulating sheath is joined with polymeric material from said radially recessed short annular sheath.

7. The method according to claim 1, wherein said engaging step includes spot welding said uninsulated portion of the free conductor length onto an axially extending flange of said electrode member.

8. The method according to claim 1, wherein said step of providing a radially recessed short annular sheath over said coiled conductor member includes imparting heat and pressure to an end portion of said first section of flexible insulating polymeric sheath to the extent that the inner surface of the thus formed radially recessed short annular sheath engages and generally conforms to the external shape of said coiled conductor member.

9. The method according to claim 1, wherein said step of providing a radially recessed short annular sheath over said coiled conductor member includes positioning a polymeric tube over said coiled conductor member and under said electrode member, which polymeric tube has an outside diameter less than that of the inside diameter of the first section of flexible insulating sheath.

10. The method according to claim 9, wherein said polymeric tube is shaped so as to have at least a portion of its inside surface engaged with and in substantial shape conformity with the outside surface of the coiled conductor member.

11. A method for constructing an implantable lead, comprising:

positioning a first section of flexible insulating polymeric sheath over a coiled conductor member having an insulator coating;

locating a short annular sheath polymeric tube over said coiled conductor member, said short annular sheath polymeric tube having an outside diameter less than that of said first section of flexible insulating polymeric sheath;

moving onto said coiled conductor member an electrode member having an electrode surface and an axially directed flange that is radially recessed with respect to the electrode surface, said electrode member having an axial bore with an internal diameter greater than the external diameter of said short annular sheath polymeric tube, and said axially directed flange having an outside diameter no greater than the greatest inside diameter of the first section of flexible insulating sheath;

imparting relative sliding movement between said electrode member and said short annular sheath polymeric tube;

uncoiling a length of said coiled conductor member and removing a portion of its insulation to form a free conductor length having an uninsulated portion;

wrapping at least a portion of said free conductor length generally around at least a portion of said electrode flange;

sliding an end portion of said first section of flexible insulating polymeric sheath over said wrapped conductor length and heat-reforming said end portion of the first section until same is secured to and is substantially isodiametric with the remainder of said first section and with the electrode surface of the electrode member; and

sliding a second section of flexible insulating polymeric sheath over said coiled conductor member and butting together said electrode member and said second section of flexible insulating polymeric sheath.

12. The method according to claim 11, wherein said electrode member includes a second axially directed flange that is radially recessed with respect to said electrode surface and that extends in a direction opposite to that of said first flange, said step of moving the electrode member with respect to the short annular sheath polymeric tube includes positioning said short annular sheath polymeric tube under said second flange, and said method further includes heat-reforming an end portion of the second section of flexible insulating polymeric sheath until same is secured to and is substantially isodiametric with the remainder of said second section and with the electrode surface of the electrode member.

13. The method according to claim 11, further including providing at least one opening through said flange portion of the electrode member, and said end portion heat-reforming step includes joining, through said opening, an internal portion of said first section of flexible insulating sheath with an external portion of said short annular sheath polymeric tube.

14. The method according to claim 12, further including forming at least one opening through said second flange portion of the electrode member, and said end portion heat-reforming step includes joining, through said opening, an internal portion of said second section of flexible insulating sheath with an external portion of said short annular sheath polymeric tube.

15. The method according to claim 11, further including flaring said end portion of the first section of flexible insulating polymeric sheath, and said heat-reforming step includes reforming said flared end portion to said substantially isodiametric condition.

16. The method according to claim 12, further including, prior to said second section sliding and butting step, flaring said end portion of the second section of flexible polymeric insulating sheath, and said step of heat-reforming the second section includes reforming said flared end portion to said substantially isodiametric condition.

17. A method for constructing an implantable lead, comprising:

selecting a length of multifilar coil having a plurality of coaxially wound coil conductors alternately interwound with each other, each said conductor being insulated;

positioning a first section of flexible insulating polymeric sheath over a length of said multifilar coil;

forming an annular, radially recessed step at an end of said first sheath section;

uncoiling a length of one of said coil conductors and removing at least a portion of its insulation to form a free conductor length;

wrapping said free conductor length generally around said annular, radially recessed step;

assembling an electrode member over said annular, radially recessed step and over said wrapped conductor length until said electrode member substantially covers at least said uninsulated portion of the wrapped conductor length and the innermost length of said recessed step and until the leading end of the first section of insulating polymeric sheath generally butts against said electrode member; and

sliding a second section of flexible insulating polymeric sheath over said multifilar coil until its leading end generally butts against said electrode member.

18. The method according to claim 17, further including:

forming an annular, radially recessed step at an opposite end of said second sheath section; and

sliding a third section of flexible insulating sheath over said multifilar coil until its leading end circumferentially engages and substantially fully covers the annular radially recessed step of said second sheath section.

19. The method according to claim 17, further including:

forming a second annular, radially recessed step on an opposite end of said second sheath section;

uncoiling a length of another of said coil conductors and removing at least a portion of its insulation to form a second free conductor length;

wrapping said second free conductor length generally around said second annular, radially recessed step;

assembling another electrode member over said second recessed step and over said second wrapped conductor length until said another electrode member substantially covers at least said uninsulated portion of the second wrapped conductor length and the innermost length of said second recessed step and until the leading end of the second section of insulating polymeric sheath generally butts against said another electrode member; and

sliding a third section of flexible insulating polymeric sheath over said multifilar coil until its leading end generally butts against said another electrode member.

20. The method according to claim 19, wherein one of said electrodes is a ventricular electrode and another of said electrodes is an atrial electrode.

21. The method according to claim 17, wherein said forming of an annular, radially recessed step includes imparting heat and pressure to a length of said sheath section.

22. The method according to claim 17, wherein said annular, radially recessed step is formed to have a length greater than the axial length of the electrode.

23. The method according to claim 17, wherein said second section sliding step is followed by imparting heat and pressure to the leading end of the second sheath section.