SYSTEM FOR LEADLESS PACING OF THE HEART

• US 20140243848A1
• Filed: 02/24/2014
• Published: 08/28/2014
• Est. Priority Date: 02/25/2013
• Status: Active Grant

• Current Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM USA (MicroPort Scientific Corp.)
• Inventors: Auricchio, Angelo, Vitali, Luca
• Granted Patent: US 9,669,223 B2
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

Devices for use in providing stimulation to cardiac tissue are provided. One device is configured for implantation in or near the heart and includes a flexible, elongate body. The body is configured to be positioned across two different sections of the vasculature such that (a) the first end can be positioned in a first section of the vasculature through which the device can stimulate a first chamber of the heart and (b) the second end can be positioned in a second section of the vasculature through which the device can stimulate a second chamber of the heart. The device further includes a receiver circuit configured to receive signals wirelessly from a transmitter device and to convert the signals into electrical power. The device also includes at least a first set of one or more electrodes configured to stimulate the heart using the electrical power.

Claims

1. A device that is configured for implantation in a vasculature within or proximate to a heart of a patient so as to accommodate stimulation of at least one of a first chamber and a second chamber of the heart, respectively, the device comprising:

a flexible, elongated body that has a first end and an opposite second end, wherein the body has a substantially isodiametric tubular shape across a length of the body between the first end and the opposite second end, wherein the body is configured to be positioned across two different sections of the vasculature such that (a) the first end can be positioned in a first section of the vasculature through which the device can stimulate the first chamber of the heart and (b) the second end can be positioned in a second section of the vasculature through which the device can stimulate the second chamber of the heart;

a receiver circuit configured to receive signals wirelessly from a transmitter device and to convert the signals into electrical power; and

at least a first set of one or more electrodes that is positioned on the body proximate to the first end and that is configured to receive the electrical power from the receiver circuit and to stimulate the heart.

2. The device according to claim 1, wherein the receiver circuit is configured to receive the signals wirelessly from the transmitter device, to convert the signals into electrical power, and to transmit the electrical power directly to the one or more electrodes to stimulate the heart.

3. The device according to claim 1, further comprising (a) an energy storage device configured to receive and to store the electrical power from the receiver circuit and (b) a stimulation circuit configured to transmit stimulation signals to the one or more electrodes using the electrical power stored in the energy storage device.

4. The device according to claim 3, wherein the signals received from the transmitter comprise control signals configured to control one or more parameters of the stimulation signals transmitted to the one or more electrodes by the stimulation circuit.

5. The device according to claim 3, wherein the stimulation circuit comprises a stimulation control circuit configured to control the provision of stimulation to the heart by the one or more electrodes without requiring external control signals to be received from the transmitter device.

6. The device according to claim 1, further comprising a second set of one or more electrodes positioned on the body proximate to the second end and configured to receive the electrical power from the receiver circuit and to stimulate the heart.

7. The device according to claim 6, wherein the first set of electrodes is positioned within the first section of the vasculature and the second set of electrodes is positioned within the second section of the vasculature, wherein at least one of the first section and the second section of the vasculature into which the body is configured to be positioned is external to the heart, and wherein at least one of the first set of electrodes and the second set of electrodes is configured to epicardially stimulate at least one of the first chamber and the second chamber of the heart.

8. The device according to claim 7, wherein the first section of the vasculature comprises a coronary vein and the second section of the vasculature comprises a coronary sinus, wherein the first set of electrodes is configured to epicardially stimulate a left ventricle of the heart, and wherein the second set of electrodes is configured to epicardially stimulate a left atrium of the heart.

9. The device according to claim 1, wherein the first and second ends are open ends and wherein the body has a central lumen that communicates with both ends.

10. The device according to claim 1, wherein the first and second ends are closed ends.

11. The device according to claim 1, wherein the receiver circuit comprises a plurality of coils distributed across the length of the body.

12. The device according to claim 1, wherein the receiver circuit is configured to receive the signals from the transmitter device using one or more of inductive coupling, radio frequency radiation, and ultrasound radiation.

13. The device according to claim 12, wherein the receiver circuit is configured to receive power signals from the transmitter device using one of inductive coupling, radio frequency radiation, and ultrasound radiation, and wherein the receiver circuit is configured to receive control signals configured to control one or more parameters of stimulation provided to the heart using another of inductive coupling, radio frequency radiation, and ultrasound radiation.

14. The device according to claim 1, wherein at least one of the first end and the second end of the body comprises a deployment attachment configured to allow a deployment device to disengage and reengage from the body within the vasculature without requiring removal of the deployment device and body from the patient.

15. The device according to claim 1, wherein at least one of the first end and the second end of the body comprises an anchoring attachment configured to stabilize at least a portion of the device in a substantially immobile position after the device has been inserted in the vasculature.

16. The device according to claim 15, wherein the anchoring attachment and at least one of the one or more electrodes together comprise an active stent.

17. The device according to claim 1, wherein the device is configured for use during a magnetic resonance imaging (MRI) procedure.

18. The device according to claim 1, further comprising an energy harvesting circuit configured to generate electrical energy to be used in stimulating the heart from flexural motion generated during a cardiac cycle.

19. A deployment device for inserting a wireless stimulation device in a vasculature within or proximate to a heart of a patient, the wireless stimulation device having an elongated, flexible body with a substantially isodiametric tubular shape across a length of the body and being configured to stimulate the heart using signals received wirelessly from a transmitter device, the deployment device comprising:

an elongated body having a first end configured to be inserted into the vasculature and a second end configured to extend outside of the patient and be used to control movement of the deployment device; and

a clamping device coupled to the first end of the elongated body and configured to be releasably coupled to an end of the wireless stimulation device,

(a) wherein the clamping device includes a plurality of prongs configured to clamp around a proximal end of the wireless stimulation device, wherein at least one of the plurality of prongs is configured to recess at least partially into at least one indentation of the proximal end of the wireless stimulation device and to allow the deployment device to rotate the wireless stimulation device,

(b) wherein the clamping device is configured to be disengaged and reengaged from the wireless stimulation device within the vasculature without requiring removal of the clamping device and wireless stimulation device from the patient, and

(c) the clamping device is configured to attach the elongated body of the deployment device to the body of the wireless stimulation device in a substantially coaxial configuration, such that a user of the deployment device may push the wireless stimulation device ahead of the clamping device and pull the wireless stimulation device behind the clamping device through the vasculature during implantation of the wireless stimulation device.

20. The deployment device according to claim 19, further comprising a sleeve configured to slide longitudinally along the elongated body, wherein the sleeve is configured to slide forward to cause the prongs to engage the wireless stimulation device and slide backward to cause the prongs to disengage from the wireless stimulation device.

21. The deployment device according to claim 19, wherein the deployment device is configured to position the wireless stimulation device in a position for the wireless stimulation device to epicardially stimulate at least one chamber of the heart.

22. The deployment device according to claim 19, wherein the deployment device comprises a central lumen, and wherein the wireless stimulation device is deployed through the use of a guiding wire.

23. The deployment device according to claim 19, wherein at least one of the first end and the second end of the body comprises an anchoring attachment configured to stabilize at least a portion of the device in a substantially immobile position after the device has been inserted in the vasculature.

24. The deployment device according to claim 23, wherein the anchoring device comprises an active stent configured to stimulate the heart.

25. A wireless stimulation device that is configured for implantation in a vasculature within or proximate to a heart of a patient so as to accommodate stimulation of at least one of a first chamber and a second chamber of the heart, respectively, the wireless stimulation device comprising:

a flexible, elongated body that has a first end and an opposite second end, wherein the body has a substantially isodiametric tubular shape across a length of the body between the first end and the opposite second end, wherein the body is configured to be positioned across two different sections of the vasculature such that (a) the first end can be positioned in a first section of the vasculature through which the device can stimulate the first chamber of the heart and (b) the second end can be positioned in a second section of the vasculature through which the device can stimulate the second chamber of the heart;

a receiver circuit configured to receive signals wirelessly from a transmitter device and to convert the signals into electrical power; and

at least a first set of one or more electrodes that is positioned on the body proximate to the first end and that is configured to receive the electrical power from the receiver circuit and to stimulate the heart,

wherein the body comprises a deployment attachment on at least one of the first end and second end configured to couple releasably to a plurality of prongs of a deployment device that is configured to insert the wireless stimulation device into the vasculature, and

wherein the deployment attachment (a) comprises one or more indentations into which one or more prongs are configured to recess to allow the deployment device to rotate the wireless stimulation device and (b) is configured to allow the deployment device to disengage and reengage from the wireless stimulation device within the vasculature without requiring removal of the deployment device and wireless stimulation device from the patient.

26. The wireless stimulation device according to claim 25, wherein the receiver circuit is configured to receive the signals wirelessly from the transmitter device, to convert the signals into electrical power, and to transmit the electrical power directly to the one or more electrodes to stimulate the heart.

27. The wireless stimulation device according to claim 25, further comprising (a) an energy storage device configured to receive and to store the electrical power from the receiver circuit and (b) a stimulation circuit configured to transmit stimulation signals to the one or more electrodes using the electrical power stored in the energy storage device.

28. The wireless stimulation device according to claim 27, wherein the signals received from the transmitter comprise control signals configured to control one or more parameters of the stimulation signals transmitted to the one or more electrodes by the stimulation circuit.

29. The wireless stimulation device according to claim 27, wherein the stimulation circuit comprises a stimulation control circuit configured to control the provision of stimulation to the heart by the one or more electrodes without requiring external control signals to be received from the transmitter device.

30. The wireless stimulation device according to claim 25, further comprising a second set of one or more electrodes positioned on the body proximate to the second end and configured to receive the electrical power from the receiver circuit and to stimulate the heart.

31. The wireless stimulation device according to claim 30, wherein the first set of electrodes is positioned within the first section of the vasculature and the second set of electrodes is positioned within the second section of the vasculature, wherein at least one of the first section and the second section of the vasculature into which the body is configured to be positioned is external to the heart, and wherein at least one of the first set of electrodes and the second set of electrodes is configured to stimulate epicardially at least one of the first chamber and the second chamber of the heart.

32. The wireless stimulation device according to claim 31, wherein the first section of the vasculature comprises a coronary vein and the second section of the vasculature comprises a coronary sinus, wherein the first set of electrodes is configured to stimulate epicardially a left ventricle of the heart, and wherein the second set of electrodes is configured to stimulate epicardially a left atrium of the heart.

33. The wireless stimulation device according to claim 25, wherein the first and second ends are open ends and wherein the body has a central lumen that communicates with both ends.

34. The wireless stimulation device according to claim 25, wherein the receiver circuit is configured to receive the signals from the transmitter device using one or more of inductive coupling, radio frequency radiation, and ultrasound radiation.

35. The wireless stimulation device according to claim 25, wherein at least one of the first end and the second end of the body comprises an anchoring attachment configured to stabilize at least a portion of the device in a substantially immobile position after the device has been inserted in the vasculature.

36. The wireless stimulation device according to claim 35, wherein the anchoring device and at least one of the one or more electrodes together comprise an active stent.

37. The wireless stimulation device according to claim 25, wherein the device is configured for use during a magnetic resonance imaging (MRI) procedure.