Hybrid system forming an active implantable medical device

• US 10,099,060 B2
• Filed: 06/19/2015
• Issued: 10/16/2018
• Est. Priority Date: 06/25/2014
• Status: Active Grant

• Current Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Original Assignee: Sorin CRM SAS (MicroPort Scientific Corp.)
• Inventors: Regnier, Willy
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US14/744,991
• Publication Number:
  US 20160008612A1
• Time in Patent Office: 1,215 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0015 characterised by features of the telemetry system
• CPC Class Codes: A61B 5/0028 Body tissue as transmission medium, i.e. transmission systems where the medium is the human body
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61N 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• 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 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

A hybrid system forming an active implantable medical device includes a subcutaneous autonomous capsule and at least one intracorporeal autonomous leadless capsule. The subcutaneous capsule is a hybrid capsule having a seal body of dimensions comparable to those of a leadless capsule, but extended by a detection/stimulation microlead, without any intermediate connector. The leadless capsule includes a seal body, anchoring means in a wall of an organ and a detection/stimulation electrode. The hybrid capsule and the leadless capsules each include transmitter/receiver means for intracorporeal mutual wireless communication so as to constitute a network wherein the hybrid capsule is the master and leadless capsules are the slaves. The hybrid capsule further includes means for centralizing data transmitted by the leadless capsules and for exchanging data with remote external equipment.

Claims

1. A system forming an active implantable medical device comprising:

a subcutaneous autonomous unit, comprising;

a first seal body housing electronic circuitry and power supply means for the electronic circuitry; and

at least one lead for detecting and/or delivering therapy extending from said first seal body, such lead comprising at least one electrode; and

at least one intracorporeal autonomous leadless capsule suitable for implantation in or against a body and comprising;

a second seal body housing electronic circuitry and power supply means for these circuits;

anchoring means coupled to a wall of said second seal body; and

at least one electrode suitable for coming into direct contact with said second seal body,

in which the subcutaneous autonomous unit and the leadless capsule each include transmitter/receiver means for intracorporeal mutual wireless communication, the subcutaneous autonomous unit operating as master and the leadless capsules operating as slaves under the control of the subcutaneous autonomous unit,

and wherein the subcutaneous autonomous unit further comprises;

centralization means of the data transmitted by the leadless capsules, and

means of communication with the outside, able to operate a remote transmission, to a remote device, of the data collected by the means of centralization of data,

wherein the at least one detection and/or therapy delivery lead is a microlead comprising at least one microcable formed of an electrically conductive core cable connected to one pole of said electronic circuits, with an insulation layer surrounding the core cable and comprising at least a selectively exposed area formed in the insulation layer and for forming said electrode for detection and/or therapy delivery,

the diameter of the microlead being at most 1 French (0.33 mm) in its distal region comprising said selectively exposed area; and

wherein the subcutaenous autonomous unit is a hybrid capsule whose volume is at most 1 cm³ and wherein;

the microlead is directly connected to the electronic circuits of the hybrid capsule,

the at least one microlead extends said first seal body on one side thereof, and

the core cable of the microcable, or of each microcable, is directly connected to a respective pole of the electronic circuits of the hybrid capsule.

2. The system of claim 1, wherein the hybrid capsule is devoid of means for anchoring to a wall of an organ.

3. The system of claim 1, wherein the seal body of the hybrid capsule is a metal body comprising at least one hermetic and electrically insulating bushing for passage of the connection of the core cable of the microcable, or of each core cable of each microcable, to the respective pole of the electronic circuits contained in the body of the hybrid capsule.

4. The system of claim 1, wherein the body of the hybrid capsule supports, at the side opposite to the side closed by the microlead, an antenna for transmitting/receiving wireless communication with said remote device.

5. The system of claim 1, wherein the at least one microlead for detection and/or therapy delivery comprises, in the proximal region of the microlead attached to the body of the hybrid capsule, a transition zone with variable stiffness gradient, decreasing in the distal direction.

6. An active implantable medical device, comprising:

an implantable master unit with a volume of at most 1 cm³, comprising;

a body housing a circuit and a power supply;

a microlead extending from the body, wherein the microlead is directly connected to the circuit, the microlead including a microcable directly connected to a pole of the circuit, wherein the diameter of the microlead is at most 1 French (0.33 mm) in a distal region;

a transmitter and a receiver for wireless communication; and

a memory; and

an implantable leadless capsule, comprising;

a body housing a circuit and a power supply;

an anchor configured to be coupled to a wall of an organ;

an electrode; and

a transmitter and a receiver for wireless communication with the master unit.

7. The active implantable medical device of claim 6, wherein the master unit does not include any mechanism for anchoring the body to a wall of an organ.

8. The active implantable medical device of claim 6, wherein the body of the master unit is a metal body comprising a hermetic and electrically insulating bushing for passage of a core cable of the microcable to the respective pole of the circuit.

9. The active implantable medical device of claim 6, wherein the master unit further comprises an antenna for wirelessly communicating with a remote device.

10. The active implantable medical device of claim 9, wherein the remote device is located outside of a patient and the antenna is used to transmit data collected from the leadless capsule and stored in the memory.

11. The active implantable medical device of claim 6, wherein the microlead comprises, in a region proximate to the body of the master unit, a transition zone with variable stiffness gradient, decreasing in a distal direction.

12. The active implantable medical device of claim 6, wherein the master unit is configured to operate as a master device and the leadless capsule is configured to operate as a slave device under the control of the master unit.

13. The active implantable medical device of claim 12, further comprising a second implantable leadless capsule, the second implantable leadless capsule including a transmitter and a receiver for wireless communication with the master unit.

14. The active implantable medical device of claim 13, wherein the second implantable leadless capsule is configured to operate as a slave device under the control of the master unit.

15. The active implantable medical device of claim 6, wherein the microcable includes an insulation layer surrounding a core cable, the insulation layer including a selectively exposed area for forming an electrode for at least one of detection or therapy delivery.

16. The active implantable medical device of claim 6, wherein the master unit is a hybrid capsule.

17. The active implantable medical device of claim 16, wherein the hybrid capsule does not include a separate electrical connector between the microlead and the hybrid capsule.

18. The active implantable medical device of claim 17, wherein the microlead further includes a second microcable and wherein the second microcable is directly connected to a second pole of the circuit.

19. The active implantable medical device of claim 6, wherein the diameter of the hybrid capsule is at most 20 French (6.6 mm).