IMPLANT ASSIST APPARATUS FOR ACOUSTICALLY ENABLED IMPLANTABLE MEDICAL DEVICE

• US 20100016840A1
• Filed: 07/01/2009
• Published: 01/21/2010
• Est. Priority Date: 07/15/2008
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Collier, Jamie S., Comisar, Marshall S., Tran, Binh C., Huelskamp, Paul J., Stahmann, Jeffrey E., Maile, Keith R., Sridharan, Krishna
• Granted Patent: US 8,934,987 B2
• Time in Patent Office: Days
• US Class Current: 606/1
• CPC Class Codes: A61B 2560/063 Devices specially adapted for delivering implantable medical measuring apparatus
• 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 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/282 Holders for multiple electrodes for introduction into the body A61B5/287
• CPC Class Codes: A61B 5/6869 Heart
• 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 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Devices, systems and methods for delivering and positioning an implantable medical device and for evaluating an acoustic communication link are disclosed. An illustrative system includes a catheter adapted to contain an implantable device with a biosensor and an acoustic transducer configured to transmit an acoustic signal, and an implant assist device in acoustic communication with the implantable device via an acoustic communication link. The implant assist device includes an acoustic transducer adapted to receive the acoustic signal transmitted by the implantable medical device, and control/processing circuitry configured to evaluate a performance of the acoustic link.

Claims

1. A system for delivering and positioning an implantable device at a target location within a patient'"'"'s body, comprising:

a catheter adapted to deliver an implantable device, the implantable device including a biosensor and at least one acoustic transducer configured to transmit an acoustic signal; and

an implant assist device in acoustic communication with the implantable device via an acoustic communication link, the implant assist device including at least one acoustic transducer adapted to receive the acoustic signal from the implantable device and circuitry configured to evaluate a performance of the acoustic communication link based at least in part on the acoustic signal transmitted from the implantable device.

2. The system of claim 1, wherein the implant assist device is an external device.

3. The system of claim 1, wherein the implant assist device is an implantable device.

4. The system of claim 1, wherein the implant assist device includes a user feedback device.

5. The system of claim 1, wherein the implant assist device is configured to receive the acoustic signal from the implantable device while the implantable device is at least partially disposed within an interior lumen of the catheter.

6. An implant assist device for evaluating an acoustic communication link with an implantable device, the implantable device configured to transmit an acoustic signal at a location within a patient'"'"'s body, the implant assist device comprising:

at least one acoustic transducer adapted to receive the acoustic signal transmitted by the implantable device;

circuitry configured to evaluate a performance of the acoustic communication link based at least in part on evaluating one or more parameters of the acoustic signal transmitted by the implantable device; and

a user interface configured to provide information indicative of the performance of the acoustic communication link to a user.

7. The implant assist device of claim 6, wherein the implant assist device is an external device.

8. The implant assist device of claim 6, wherein the implant assist device is an implantable device.

9. A method for evaluating an acoustic communication link between an implantable device and an implant assist device, comprising:

establishing an acoustic communication link between the implantable device and the implant assist device, the implant assist device including an acoustic transducer configured to receive an acoustic signal transmitted by the implantable device and circuitry configured to evaluate a performance of the acoustic communication link;

evaluating the performance of the acoustic communication link between the implant assist device and the implantable device based at least in part on one or more parameters associated with the acoustic signal; and

providing information to a user interface indicating the performance of the acoustic communication link.

10. The method of claim 9, wherein establishing an acoustic communication link between the implantable device and the implant assist device includes transmitting the acoustic signal while the implantable device is at least partially disposed within an interior lumen of a delivery catheter.

11. The method of claim 9, wherein evaluating the performance of the acoustic communication link includes evaluating a signal strength and quality of the acoustic signal received by the implant assist device.

12. The method of claim 9, wherein evaluating the performance of the acoustic communication link includes evaluating at least one of a noise floor level parameter, carrier frequency parameter, signal timing parameter, signal duration parameter, signal morphology parameter, receiver gain parameter, receiver threshold parameter, carrier frequency parameter, decode ratio parameter, bit error rate parameter, bit correction rate parameter, an acoustic dampening parameter, and wake-up threshold margin parameter.

13. The method of claim 9, wherein the one or more parameters includes signal amplitude, and where evaluating the performance of the acoustic communication link includes comparing the amplitude of the acoustic signal against a threshold amplitude value.

14. The method of claim 9, wherein the one or more parameters includes a plurality of weighted parameters.

15. The method of claim 9, further comprising adjusting a pulse count or pulse duration of the acoustic signal transmitted by the implantable device, and wherein evaluating the performance of the acoustic communication link includes evaluating a response of the acoustic signal to the adjusted pulse count or pulse duration.

16. The method of claim 9, further comprising adjusting a clock skew of the acoustic signal, and wherein evaluating the performance of the acoustic communication link includes evaluating a response of the acoustic signal to the adjusted clock skew.

17. The method of claim 9, wherein establishing an acoustic communication link includes transmitting a first acoustic signal from the implant assist device to the implantable device and receiving a second acoustic signal from the implantable device, wherein the second acoustic signal received from the implantable device is proportional in amplitude to the first acoustic signal.

18. A method for delivering and positioning an implantable device at a target location within a patient'"'"'s body, the method comprising:

introducing a delivery catheter into a patient'"'"'s body, the delivery catheter including a distal portion having a lumen containing an implantable device including a biosensor and an acoustic transducer adapted to transmit an acoustic signal;

advancing the delivery catheter to a target region within the patient'"'"'s body;

establishing an acoustic communication link between the implantable device within the catheter and an implant assist device, the implant assist device including an acoustic transducer adapted to receive the acoustic signal from the implantable device and circuitry configured to evaluate a performance of the acoustic communication link;

evaluating the performance of the acoustic communication link between the implant assist device and the implantable device based at least in part on one or more parameters associated with the acoustic signal;

providing information to a user interface indicating the performance of the acoustic communication link; and

deploying the implantable device at a target region within the patient'"'"'s body.

19. The method of claim 18, wherein evaluating the performance of the acoustic communication link includes evaluating a signal strength and quality of the acoustic signal received by the implant assist device.

20. The method of claim 18, wherein the target region is within a pulmonary artery.

21. The method of claim 18, further comprising adjusting a position of the implantable device within the target region based at least in part on the signal strength of the acoustic communication link.

22. The method of claim 18, wherein the position of the implantable device is adjusted by moving or rotating the catheter within the body based on feedback from the user interface.

23. The method of claim 18, further comprising re-evaluating the performance of the acoustic communication link once the implantable device is adjusted within the target region.

24. The method of claim 18, further comprising confirming the performance of the acoustic communication link between the implantable device and the implant assist device after deployment of the implantable device within the body.

25. The method of claim 18, wherein evaluating the acoustic communication link includes transmitting a first acoustic signal from the implant assist device to the implantable device and receiving a second acoustic signal from the implantable device, wherein the second acoustic signal received from the implantable device is proportional in amplitude to the first acoustic signal.