Electrically isolating electrical components in a medical electrical lead with an active fixation electrode

• US 8,224,440 B2
• Filed: 09/01/2010
• Issued: 07/17/2012
• Est. Priority Date: 11/09/2006
• Status: Expired due to Fees

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Bauer, Ryan Thomas, Brainard, Scott, Kane, Lawrence M., Dabney, Warren S., Johnson, Robert Shawn, Stevenson, Robert A., Moschiano, Holly Noelle
• Primary Examiner(s): Manuel, George
• Application Number:
  US12/873,862
• Publication Number:
  US 20100324640A1
• Time in Patent Office: 685 Days
• Field of Search: 607/2
• US Class Current: 607/2
• 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/086 Magnetic resonance imaging [MRI] compatible leads
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents
• CPC Class Codes: H01F 2017/065 Core mounted around conductor to absorb noise, e.g. EMI filter
• CPC Class Codes: H01F 27/027 specially adapted for combination of signal type inductors or transformers with electronic circuits, e.g. mounting on printed circuit boards
• CPC Class Codes: H01F 27/40 Structural association with built-in electric component, e.g. fuse
• CPC Class Codes: H03H 1/0007 of radio frequency interference filters
• CPC Class Codes: H03H 2001/0042 Wound, ring or feed-through type capacitor
• CPC Class Codes: H03H 2007/013 Notch or bandstop filters
• CPC Class Codes: H03H 7/0115 comprising only inductors and capacitors H03H7/075, H03H7/09, H03H7/12, H03H7/13 take precedence

Abstract

A lead body adapted for in-vivo implantation in a living subject includes a proximal end configured for electrical and mechanical connection to a therapy or a monitoring device, and a distal end. A collar is disposed at the distal end of the lead body, and a casing is disposed within the collar and is translatable along a central longitudinal axis of the collar. At least one electrical conductor extends substantially the length of the lead body, and an electronic component is disposed within the casing and conductively coupled to the electrical conductor. An electrode is mechanically connected to the casing and conductively coupled to the electronic component. A seal is disposed between the casing assembly and the collar to prevent passage of ionic fluid into the lead body through its distal end.

Claims

1. An implantable medical lead, comprising:

a) a lead body adapted for in-vivo implantation in a living subject, the lead body comprising at least one electrical conductor extending from a conductor distal end to a conductor proximal end that is configured to be electrically connectable to a therapy delivery or a monitoring device;

b) a collar disposed at the distal end of the lead body, the collar comprising a proximal collar end extending to an open distal collar end;

c) a casing extending from a proximal casing end to a distal casing end, wherein the casing is disposed within the collar and translatable along a longitudinal axis thereof;

d) at least one electronic component disposed within the casing, but electrically insulated therefrom, wherein the electronic component is electrically coupled to the distal end of the electrical conductor;

e) an electrode electrically connected to the electronic component at the distal casing end; and

f) a seal supported by at least one of the collar and the casing and extending to the other of the collar and the casing so as to substantially prevent passage of fluid to the proximal casing end from the open distal collar end,

g) wherein the at least one electrical conductor, the casing and the electrode are axially translatable along the collar to extend the electrode distally beyond the open distal collar end and to alternatively retract the electrode proximally into the collar as a contact location of the seal between an inner surface of the collar and an outer surface of the casing changes upon such axial proximal and distal translation thereof.

2. The lead of claim 1, wherein the seal is supported at at least one of a distal end, a proximal end, or along a middle of the casing.

3. The lead of claim 1, wherein the seal is supported by the collar, fixed relative to the casing.

4. The lead of claim 1, wherein the seal is supported by the casing, fixed relative to the collar.

5. The lead of claim 1, wherein the at least one electrical component is selected from the group consisting of a bandstop filter, an electronic switch, a MEMS switch, a diode array, a multiplexer, a PIN diode, a capacitor, a resister, an inductor, and any combination thereof.

6. The lead of claim 1, including an insulative conformal coating disposed about at least a portion of the casing.

7. The lead of claim 6, wherein the conformal coating comprises a dielectric ceramic coating.

8. The lead of claim 6, wherein the conformal coating is characterized as having been applied by a process selected from the group consisting of sputtering, chemical vapor deposition, physical vapor deposition, dipping in a chemical solution, and by applying a chemical solution.

9. The lead of claim 6, wherein the conformal coating comprises alumina or parylene.

10. The lead of claim 1, wherein the casing comprises a dielectric ceramic coating.

11. The lead of claim 1, wherein the casing comprises alumina.

12. The lead of claim 1, wherein the casing comprises a distal pin and a proximal pin, both pins being electrically insulated from the casing, and wherein the at least one electrical conductor is attached to the proximal pin and the electrode is attached to the distal pin.

13. The lead of claim 12, including a drive shaft connected to a distal end of the at least one electrical conductor.

14. The lead of claim 13, wherein the drive shaft comprises a hollow stylet-receiving drive shaft.

15. The lead of claim 14, wherein the hollow stylet-receiving drive shaft comprises a rigid tube surrounding at least a portion of the proximal pin of the casing.

16. The lead of claim 12, including an insulative conformal coating disposed about the proximal pin such that the proximal and distal pins are electrically insulated when surrounded by an ionized fluid.

17. The lead of claim 1, wherein the seal comprises a plurality of seals.

18. The lead of claim 1, wherein the seal is selected from the group consisting of multiple wipers, o-rings, thin disks, and thin sheets.

19. The lead of claim 1, wherein the seal comprises a bellows disposed between the collar and the casing.

20. The lead of claim 19, wherein the bellows is expandable and collapsible.

26. The lead of claim 2 wherein the conformal coating comprises a dielectric ceramic coating comprising alumina characterized as having been applied by a process selected from the group consisting of sputtering, chemical vapor deposition, physical vapor deposition, dipping in a chemical solution and and applying a chemical solution.

21. An implantable medical lead, comprising:

a) a lead body adapted for in-vivo implantation in a living subject, the lead body comprising at least one electrical conductor extending from a conductor distal end to a conductor proximal end that is configured to be electrically connectable to a therapy delivery or a monitoring device;

b) a collar disposed at the distal end of the lead body, the collar comprising a proximal collar end extending to an open distal collar end;

c) a casing extending from a proximal casing end to a distal casing end, wherein the casing is disposed within the collar and translatable along a longitudinal axis thereof;

d) at least one electronic component disposed within the casing, but electrically insulated therefrom, wherein the electronic component is electrically coupled to the distal end of the electrical conductor;

e) an electrode electrically connected to the electronic component at the distal casing end;

f) a seal supported by at least one of the collar and the casing and extending to the other of the collar and the casing so as to substantially prevent passage of fluid to the proximal casing end from the open distal collar end; and

g) an insulative conformal coating disposed about at least a portion of the casing, the at least one electrical conductor, or both

h) wherein the at least one electrical conductor, the casing and the electrode are axially translatable along the collar to extend the electrode distally beyond the open distal collar end and to alternatively retract the electrode proximally into the collar as a contact location of the seal between an inner surface of the collar and an outer surface of the casing changes upon such axial proximal and distal translation thereof.

22. The lead of claim 21, wherein the seal is fixed relative to the casing or the collar.

23. The lead of claim 21, wherein the seal is selected from the group consisting of a plurality of seals, multiple wipers, o-rings, thin disks, thin sheets, and a bellows disposed between the collar and the casing.

24. The lead of claim 23, wherein the bellows is expandable and collapsible.

25. The lead of claim 21, wherein the at least one electrical component is selected from the group consisting of a bandstop filter, an electronic switch, a MEMS switch, a diode array, a multiplexer, a PIN diode, a capacitor, a resister, an inductor, and any combination thereof.

27. The lead of claim 21, wherein the insulative conformal coating comprises a dielectric ceramic coating comprising alumina.

28. The lead of claim 21, wherein the casing comprises a distal pin and a proximal pin, both pins being electrically insulated from the casing, and wherein the at least one electrical conductor is attached to the proximal pin and the electrode is attached to the distal pin.

29. The lead of claim 28 wherein the insulative conformal coating is disposed about the proximal pin such that the proximal and distal pins are electrically insulated when surrounded by an ionized fluid.

30. The lead of claim 29, including a drive shaft connected to a distal end of the at least one electrical conductor.

31. The lead of claim 30, wherein the drive shaft comprises a hollow stylet-receiving drive shaft including a rigid tube surrounding at least a portion of the proximal pin of the casing.

32. An implantable medical lead, comprising:

a) a lead body adapted for in-vivo implantation in a living subject, the lead body comprising at least one electrical conductor extending from a distal end to a proximal end that is configured to be electrically connectable to a therapy delivery or a monitoring device;

b) a collar disposed at the distal end of the lead body, the collar comprising a proximal collar end extending to an open distal collar end;

c) a casing extending from a proximal pin at a proximal casing end to a distal pin at a distal casing end, wherein the casing is disposed within the collar and translatable along a longitudinal axis thereof and wherein the proximal and distal pins are electrically insulated from the casing;

d) at least one electronic component disposed within the casing, but electrically insulated therefrom, wherein the electronic component is electrically coupled to the electrical conductor at the proximal pin;

e) an electrode mechanically and electrically coupled to the electronic component at the distal pin; and

f) a seal disposed between the casing and the collar to substantially prevent passage of fluid to the proximal casing end from the open distal collar end thereof.

33. An implantable medical lead, comprising:

a) a lead body adapted for in-vivo implantation in a living subject, the lead body comprising at least a first and a second electrical conductors extending from respective first and second distal ends to first and second proximal ends that are configured to be electrically connectable to a therapy delivery or a monitoring device;

b) a collar disposed at the distal end of the first electrical conductor, the collar comprising a proximal collar end extending to an open distal collar end;

c) a casing extending from a proximal casing end to a distal casing end, wherein the casing is disposed within the collar and translatable along a longitudinal axis thereof;

d) at least one electronic component disposed within the casing, but electrically insulated therefrom, wherein the electronic component is electrically coupled to the distal end of the second electrical conductor;

e) an electrode electrically connected to the electronic component at the distal casing end; and

f) a seal supported by at least one of the collar and the casing and extending to the other of the collar and the casing so as to substantially prevent passage of fluid to the proximal casing end from the open distal collar end,

g) wherein the second electrical conductor, the casing and the electrode are axially translatable along the collar to extend the electrode distally beyond the open distal collar end and to alternatively retract the electrode proximally into the collar as a contact location of the seal between an inner surface of the collar and an outer surface of the casing changes upon such axial proximal and distal translation thereof.

34. An implantable medical lead, comprising:

a) a lead body adapted for in-vivo implantation in a living subject, the lead body comprising at least a first and a second electrical conductors extending from respective first and second distal ends to first and second proximal ends that are configured to be electrically connectable to a therapy delivery or a monitoring device;

b) a collar disposed at the distal end of the first electrical conductor, the collar comprising a proximal collar end extending to an open distal collar end;

c) a casing extending from a proximal casing end to a distal casing end, wherein the casing is disposed within the collar and translatable along a longitudinal axis thereof;

d) at least one electronic component disposed within the casing, but electrically insulated therefrom, wherein the electronic component is electrically coupled to the distal end of the second electrical conductor;

e) an electrode electrically connected to the electronic component at the distal casing end; and

f) an annular seal supported by the casing and extending to the collar to substantially prevent passage of fluid to the proximal casing end from the open distal collar end thereof,

g) wherein the second electrical conductor, the casing and the electrode are axially translatable along the collar to extend the electrode distally beyond the open distal collar end and to alternatively retract the electrode proximally into the collar as a contact location of the seal against an inner surface of the collar changes upon such axial proximal and distal translation thereof.

35. An implantable medical lead, comprising:

a) a lead body adapted for in-vivo implantation in a living subject, the lead body comprising at least one electrical conductor extending from a conductor distal end to a conductor proximal end that is configured to be electrically connectable to a therapy delivery or a monitoring device;

b) a collar disposed at the distal end of the lead body, the collar comprising a proximal collar end extending to an open distal collar end;

c) a casing extending from a proximal casing end to a distal casing end, wherein the casing is disposed within the collar and translatable along a longitudinal axis thereof;

d) at least one electronic component disposed within the casing, but electrically insulated therefrom, wherein the electronic component is electrically coupled to the distal end of the at least one electrical conductor;

e) an electrode electrically connected to the electronic component at the distal casing end; and

f) a seal support connected between the distal casing end and the electrode, the seal support supporting an annular seal extending to the collar to substantially prevent passage of fluid to the proximal casing end from the open distal collar end thereof,

g) wherein the at least one electrical conductor, the casing, the seal support including the seal, and the electrode are axially translatable along the collar to extend the electrode distally beyond the open distal collar end and to alternatively retract the electrode proximally into the collar as a contact location of the seal against an inner surface of the collar changes upon such axial proximal and distal translation thereof.

36. The implantable medical lead of claim 35 wherein the collar is electrically connected to a second electrical conductor.

37. An implantable medical lead, comprising:

a) a lead body adapted for in-vivo implantation in a living subject, the lead body comprising at least one electrical conductor extending from a conductor distal ends to a conductor proximal end that is configured to be electrically connectable to a therapy delivery or a monitoring device;

b) a collar disposed at the distal end of the lead body, the collar comprising a proximal collar end extending to an open distal collar end;

c) a casing extending from a proximal casing end to a distal casing end, wherein the casing is disposed within the collar and translatable along a longitudinal axis thereof;

d) at least one electronic component disposed within the casing, but electrically insulated therefrom, wherein the electronic component is electrically coupled to the distal end of the electrical conductor;

e) an electrode electrically connected to the electronic component at the distal casing end;

f) a seal support connected between the distal casing end and the electrode, the seal support supporting a first, annular seal extending to the collar to substantially prevent passage of fluid to the proximal casing end from the open distal collar end thereof; and

g) a second seal supported by at least one of the collar and the casing and extending to the other of the collar and the casing so as to substantially prevent passage of fluid to the proximal casing end,

h) wherein the at least one electrical conductor, the casing, the seal support including the first seal, and the electrode are axially translatable along the collar to extend the electrode distally beyond the open distal collar end and to alternatively retract the electrode proximally into the collar as a contact location of the first seal against an inner surface of the collar changes and as a contact location of the second seal between the inner surface of the collar and an outer surface of the casing changes upon such axial proximal and distal translation thereof.

38. The implantable medical lead of claim 37 wherein the collar is electrically connected to a second electrical conductor.