Monitoring system for remote detection of endoleaks and/or changes in morphology of implanted endoluminal devices
View Patent ↗An endoluminal device including a prosthesis and at least one indicator member affixed to the prosthesis that can be remotely monitored to indicate a change in pressure or morphology of the prosthesis. The indicator member may be an optical fiber, a strain gauge, or a first material having a first magnetic resonance imaging (MRI) susceptibility value that contrasts with a second MRI susceptibility value of a second material that comprises one or more remaining members of the prosthesis. A prosthesis monitoring system includes an endoluminal device as well as a subcutaneous electronics package and external electronics. Methods of detecting endoleaks or changes in morphology involve implanting an endoluminal device with the indicator and detecting information from the indicator.
1. A monitoring system for an endoluminal device comprising:
the endoluminal device for implantation in a lumen;
at least a first optical fiber member having a first end affixed to the endoluminal device and a second end;
a light source in communication with the first optical fiber at the second end for sending an input optical signal through the optical fiber;
a spectrometer in communication with the first optical fiber at the second end for receiving an output optical signal from the optical fiber; and
a transmitter responsive to the spectrometer for transmitting information related to the output optical signal.
2. The monitoring system of claim 1 wherein the prosthesis is deployed to isolate an aneurysm having an aneurysm sac, the system further comprising:
a second optical fiber having a first end disposed in or on the aneurysm sac and a second end in communication with the light source and the spectrometer.
3. The monitoring system of claim 2 wherein the first optical fiber and the second optical fiber are each configured to measure pressure at the first ends of the first and second optical fibers.
4. The monitoring system of claim 1 wherein the light source, spectrometer, and transmitter comprise subcutaneous electronics adapted to be subcutaneously implanted.
5. The monitoring system of claim 4 wherein the subcutaneous electronics are adapted to be sutured to a portion of skin.
6. The monitoring system of claim 4 wherein the transmitter is adapted to generate an electromagnetic signal or an optical signal transmittable through human skin.
7. The monitoring system of claim 4 wherein the subcutaneous electronics further comprise a battery.
8. The monitoring system of claim 7 wherein the subcutaneous electronics further comprise a remotely-activatable switch for turning power from the battery on and off.
9. The monitoring system of claim 8 wherein the switch is a magnetic switch.
10. The monitoring system of claim 1 wherein the first optical fiber is configured to measure bending of the optical fiber.
11. The monitoring system of claim 1 wherein the first optical fiber is configured to measure pressure at the first end of the optical fiber.
12. The monitoring system of claim 1 , wherein the endoluminal device comprises a prosthesis.
13. The monitoring system of claim 1 , wherein the endoluminal device comprises a stent, a graft, or a combination thereof.
14. A monitoring system at least partially implantable within a body for detecting a change in morphology of an implanted endoluminal device, the system comprising:
an indicator affixed to the endoluminal device for indicating a change in morphology of the endoluminal device in a remotely measurable manner; and
a remote monitoring device for detecting the indication of the change in morphology provided by the indicator;
wherein the indicator comprises at least one optical fiber.
15. The monitoring system of claim 14 wherein the system further comprises:
means, in communication with the means for conveying, for sending an input optical signal and receiving an output optical signal from the optical fiber.
16. The monitoring system of claim 14 , wherein the endoluminal device comprises a prosthesis.
17. The monitoring system of claim 14 , wherein the endoluminal device comprises a stent, a graft, or a combination thereof.
18. A monitoring system at least partially implantable within a body for detecting a change in morphology of an implanted endoluminal device, the system comprising:
at least one indicator member integral to the endoluminal device that has a first magnetic resonance imaging (MRI) susceptibility value that contrasts with a second MRI susceptibility value of a second material that comprises one or more remaining members of the endoluminal device, the indicator member having a configuration adapted to change in response to the change in morphology;
a remote monitoring device comprising a magnetic resonance imager adapted to remotely detect the configuration of the member to detect the change in the indicator member effected by the change in morphology; and
means for conveying information from the indicator member to the remote monitoring device.
19. The monitoring system of claim 18 , wherein the endoluminal device comprises a prosthesis.
20. The monitoring system of claim 18 , wherein the endoluminal device comprises a stent, a graft, or a combination thereof.
21. The monitoring system of claim 18 , wherein the first material of the indicator member has a positive MRI susceptibility value and second material of the one or more remaining members of the prosthesis has a negative MRI susceptibility value.
22. A prosthesis monitoring system at least partially implantable within a body for detecting an endoleak in an implanted prosthesis, the system comprising:
an implantable indicator for indicating a change in pressure attributable to an endoleak, the indicator comprising at least one optical fiber;
means for sending an input optical signal and for receiving an output optical signal through the optical fiber; and
remote monitoring means for detecting the indication of the change in pressure provided by the indicator.
23. The prosthesis monitoring system of claim 22 wherein the indicator is integral to the prosthesis.
24. The prosthesis monitoring system of claim 23 , wherein the prosthesis comprises an aortic trunk and at least one iliac leg and the indicator member is integral to the at least one iliac leg.
25. The prosthesis monitoring system of claim 22 wherein the prosthesis is adapted to be deployed to isolate an aneurysm having an aneurysm sac and the indicator is adapted to be disposed in the aneurysm sac.
26. The prosthesis monitoring system of claim 22 wherein the prosthesis is adapted to be deployed to isolate an aneurysm having an aneurysm sac and the indicator comprises a first optical fiber member adapted to be mounted (a) in the aneurysm sac to detect pressure or (b) on the aneurysm sac to detect (b)(i) a change in morphology of the aneurysm sac or (b)(ii) pulsatile motion of the sac.
27. The prosthesis monitoring system of claim 26 wherein the indicator consists of only the first optical fiber member.
28. The prosthesis monitoring system of claim 22 wherein the prosthesis is adapted to be deployed to isolate an aneurysm having an aneurysm sac and the indicator comprises a first optical fiber member adapted to be mounted in the aneurysm sac to detect pressure, and a second optical fiber member affixed to the prosthesis and that is adapted to detect pressure, the system further comprising means for sending a first input optical signal and receiving a first output optical signal through the first optical fiber and sending a second input optical signal and receiving a second output optical signal through the second optical fiber.
29. A monitoring system at least partially implantable within a body for detecting a change in pressure or morphology of a prosthesis, the prosthesis comprising a graft and a stent having a compressed configuration for introduction into the body and an expanded configuration for deployment in the body, the system comprising:
an indicator sandwiched between the graft and the stent in the expanded configuration for indicating a change in morphology of the prosthesis in a remotely measurable manner, wherein the indicator comprises a strain gauge; and
a remote monitoring device for detecting the indication of the change in morphology provided by the indicator.
30. A monitoring system at least partially implantable within a body for detecting a change in pressure or morphology of a prosthesis, the prosthesis comprising a graft and a stent having a compressed configuration for introduction into the body and an expanded configuration for deployment in the body, the system comprising:
an indicator sandwiched between the graft and the stent in the expanded configuration for indicating a change in morphology of the prosthesis in a remotely measurable manner, wherein the indicator comprises a first material having a first magnetic resonance imaging (MRI) susceptibility value that contrasts with a second MRI susceptibility value of a second material that comprises one or more remaining members of the prosthesis; and
a remote monitoring device for detecting the indication of the change in morphology provided by the indicator.
31. A prosthesis monitoring system at least partially implantable within a body for detecting a change in pressure or morphology of an implanted prosthesis, the system comprising:
the prosthesis, comprising an aortic trunk and at least one iliac leg;
an indicator member affixed to the iliac leg of the prosthesis for indicating a change in morphology of the prosthesis in a remotely measurable manner, wherein the indicator member is adapted to be remotely monitored to indicate a change in pressure or morphology of the prosthesis, the indicator member comprising an optical fiber, a strain gauge, or a first material having a first magnetic resonance imaging (MRI) susceptibility value that contrasts with a second MRI susceptibility value of a second material that comprises one or more remaining members of the prosthesis; and
a remote monitoring device for detecting the indication of the change in morphology provided by the indicator.
32. The monitoring system of claim 31 , wherein the indicator member is woven into the iliac leg of the prosthesis.
33. The monitoring system of claim 31 , wherein the first material of the indicator member has a positive MRI susceptibility value and second material of the one or more remaining members of the prosthesis has a negative MRI susceptibility value.