Cardiac stimulation using leadless electrode assemblies

• US 8,644,934 B2
• Filed: 09/13/2007
• Issued: 02/04/2014
• Est. Priority Date: 09/13/2006
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Hastings, Roger N., Lafontaine, Daniel M., Pikus, Michael J., Willard, Martin R.
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): KIMBALL, JEREMIAH T
• Application Number:
  US11/854,844
• Publication Number:
  US 20090018599A1
• Time in Patent Office: 2,336 Days
• Field of Search: 607/60, 607/32, 607/65, 128/903
• US Class Current: 607/32
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An implantable cardiac tissue excitation system includes an implantable pacing controller unit with a pulse generation circuit. The system also includes a lead with a lead body extending between a proximal lead end attachable to the pacing controller unit and a distal lead end configured to be implanted within a heart. A lead conductor extends within the lead body. The system also includes a transmitter assembly located near the distal lead end that is electrically connected to the pulse generation circuit through the lead conductor to wirelessly transmit pacing control information and pacing energy. The system also includes a leadless electrode assembly configured to be implanted within the heart that includes a receiver to receive the wireless transmission, a charge storage unit to store the charge energy, and an electrical stimulation circuit to deliver an electrical stimulus to cardiac tissue using the pacing control information and the charge energy.

Claims

1. A cardiac tissue excitation lead, comprising:

a flexible elongate lead body having a proximal end adapted to be inserted into an implantable pulse generator assembly and having a distal end adapted to be positioned within a heart;

one or more lead conductors extending within the lead body; and

a plurality of transmitter assemblies located at different locations along a length of the lead body near the distal end of the lead body and electrically connected to the pulse generator assembly via the one or more lead conductors to wirelessly transmit pacing control information and pacing energy from respective transmitter assemblies to respective implantable leadless electrode assemblies;

wherein the respective transmitter assemblies include at least one transmitter assembly that is configured to control a respective implantable leadless electrode assembly independently of other leadless electrode assemblies.

2. The cardiac tissue excitation lead of claim 1, wherein at least one of the plurality of transmitter assemblies comprises a coil wound around a ferrite core.

3. The cardiac tissue excitation lead of claim 2, wherein the wireless transmission of pacing control information and pacing energy occurs when the pulse generator assembly supplies a time-varying current to the coil through the lead conductor to emit a magnetic field.

4. The cardiac tissue excitation lead of claim 1, wherein at least one of the plurality of transmitter assemblies comprises an ultrasonic transducer.

5. The cardiac tissue excitation lead of claim 4, wherein the wireless transmission of pacing control information and pacing energy occurs when the pulse generator assembly supplies an electrical current to the ultrasonic transducer through the lead conductor to emit an ultrasonic beam.

6. The cardiac tissue excitation lead of claim 1, wherein at least one of the plurality of transmitter assemblies comprises a pair of separated electrodes.

7. The cardiac tissue excitation lead of claim 6, wherein the wireless transmission of pacing control information and pacing energy occurs when the pulse generator assembly supplies a time-varying current through the lead conductor across the pair of separated electrodes to emit an electric field.

8. The cardiac tissue excitation lead of claim 1, further comprising a first magnet positioned near at least one of the plurality of transmitter assemblies that magnetically attracts a second magnet included with a respective leadless electrode assembly to orient the transmitter assembly and the respective leadless electrode assembly.

9. The cardiac tissue excitation lead of claim 1, wherein the pacing control information includes pace timing information and a pace trigger signal.

10. The cardiac tissue excitation lead of claim 1, wherein each of the transmitter assemblies in the plurality of transmitter assemblies transmits pacing control information and pacing energy to a different implantable leadless electrode assembly in a plurality of respective implantable leadless electrode assemblies.

11. The cardiac tissue excitation lead of claim 1, wherein the respective transmitter assemblies are configured to be coupled to the implantable pulse generator assembly including coupling to a pacing controller unit that is commonly shared amongst the respective transmitter assemblies.

12. An implantable cardiac tissue excitation system, comprising:

an implantable pacing controller unit comprising a pulse generation circuit;

a lead comprising a lead body extending between a proximal lead end attachable to the pacing controller unit and a distal lead end configured to be implanted within a heart, one or more lead conductors extending within the lead body, and a plurality of transmitter assemblies located at different locations along a length of the lead body near the distal lead end, the transmitter assemblies electrically connected to the pulse generation circuit through at least one lead conductor to wirelessly transmit pacing control information and charge energy from the transmitter assemblies when the pulse generation circuit provides an electrical current to the transmitter assemblies through the lead conductor; and

respective leadless electrode assemblies configured to be implanted within the heart and each comprising a receiver to receive the wireless transmission from a respective lead transmitter assembly, a charge storage unit to store the charge energy, and an electrical stimulation circuit to deliver an electrical stimulus to cardiac tissue using the pacing control information and the charge energy;

wherein the respective transmitter assemblies include at least one transmitter assembly that is configured to control a respective implanted leadless electrode assembly independently of the other leadless electrode assemblies according to control signals from the implantable pacing controller unit.

13. The implantable cardiac tissue excitation system of claim 12, further comprising implantable remote pacing stimulators in communicable contact with a respective leadless electrode assembly, each of the one or more remote pacing stimulators located in the heart and configured to apply pacing stimuli to surrounding heart tissue at the direction of the respective leadless electrode assembly.

14. The implantable cardiac tissue excitation system of claim 13, wherein each of the remote pacing stimulators communicates with the respective leadless electrode assembly wirelessly.

15. The implantable cardiac tissue excitation system of claim 13, wherein each of the one or more remote pacing stimulators communicates with the respective leadless electrode assembly over a wire between the respective leadless electrode assembly and the remote pacing stimulator.

16. The implantable cardiac tissue excitation system of claim 12, wherein a respective leadless electrode assembly further comprises a sense circuit for sensing electrical cardiac activity and a transmitter for wirelessly transmitting information associated with the sensed electrical cardiac activity.

17. The implantable cardiac tissue excitation system of claim 12, wherein the pacing controller passes a time-varying current through a respective transmitter assembly to generate an electric field to transmit the pacing control information and charge energy.

18. The implantable cardiac tissue excitation system of claim 12, wherein a respective transmitter assembly comprises a coil enclosing at least a portion of a ferrite core.

19. The implantable cardiac tissue excitation system of claim 18, wherein the pacing controller passes a time-varying current through the coil to generate a magnetic field to transmit the pacing control information and charge energy.

20. The implantable cardiac tissue excitation system of claim 12, wherein a respective transmitter assembly comprises a magnetic coil.

21. The implantable cardiac tissue excitation system of claim 20, wherein a respective leadless electrode assembly includes a magnet, and wherein a magnetic force between the magnetic coil and the magnet assists in orienting the respective leadless electrode assembly.

22. The implantable cardiac tissue excitation system of claim 12, further comprising a magnet assembly configured to be affixed to a heart wall and including a magnet that attracts a magnet included in a respective leadless assembly to position the respective leadless electrode assembly.

23. A method of operating a cardiac pacing system, the method comprising:

transmitting respective energy signals wirelessly using a wired lead whose distal end is positioned within a heart, using respective transmitter assemblies located at different locations along a length of a lead body of the wired lead near the distal end, and whose proximal end is coupled to a pulse generator;

receiving the transmitted energy signals at respective wireless pacing electrode assemblies coupled respectively to the respective transmitter assemblies, the respective transmitter assemblies positioned within the heart; and

controlling issuance of a pacing pulse from a respective wireless pacing electrode independently of other wireless pacing electrodes using a respective transmitter assembly.

24. The method of claim 23, wherein the energy transmission comprises charging energy and pacing information.

25. The method of claim 23, wherein transmitting a respective energy signal wirelessly from the wired lead comprises generating an electric field created at the wired lead positioned in a first chamber of the heart.

26. The method of claim 23, wherein transmitting a respective energy signal wirelessly from a wired lead comprises generating a magnetic field created at the wired lead positioned in a first chamber of the heart.

27. The method of claim 23, wherein transmitting a respective energy signal wirelessly from a wired lead comprises generating an ultrasonic beam at the wired lead positioned in a first chamber of the heart.

28. The method of claim 23, wherein a plurality of wireless pacing electrode assemblies receive respective transmitted energy signals.

29. The method of claim 23, wherein the distal end of the wired lead is positioned in a first chamber of the heart and at least one of the wireless pacing electrode assemblies is positioned in a second, different chamber of the heart.

30. The method of claim 29, wherein the first chamber is a right ventricle of the heart and the second chamber is a left ventricle of the heart.

31. A method of operating a cardiac pacing system, the method comprising:

transmitting respective energy signals wirelessly using a wired lead whose distal end is positioned in a first chamber of a heart, using respective transmitter assemblies located at different locations along a length of a lead body of the wired lead near the distal end, and whose proximal end is coupled to a pulse generator;

receiving the transmitted energy signals at respective wireless pacing electrode assemblies coupled respectively to the respective transmitter assemblies, the respective transmitter assemblies positioned within a second chamber of the heart; and

controlling issuance of a pacing pulse from a respective wireless pacing electrode assembly independently of other wireless pacing electrode assemblies using a respective transmitter assembly, including inhibiting issuance of a pacing pulse when a native cardiac electrical signal is sensed by the respective wireless pacing electrode assembly within a specified time period from receipt of a respective transmitted energy signal by the respective wireless pacing electrode assembly.

32. The method of claim 31, wherein the energy transmission comprises charging energy and pacing information.

33. The method of claim 31, wherein a respective wireless pacing electrode assembly includes sense circuitry to sense the native cardiac electrical signal.

34. The method of claim 31, wherein transmitting a respective energy signal wirelessly from the wired lead comprises generating an electric field created at the wired lead implanted in the first chamber of the heart.

35. The method of claim 31, wherein transmitting a respective energy signal wirelessly from the wired lead comprises generating a magnetic field created at the wired lead implanted in the first chamber of the heart.

36. The method of claim 31, wherein transmitting a respective energy signal wirelessly from the wired lead comprises generating an ultrasonic beam at the wired lead implanted in the first chamber of the heart.

37. The method of claim 31, wherein the native cardiac electrical signal originates at a sino-atrial node of the heart.