Endoluminal implant with fluid flow sensing capability

• US 5,967,986 A
• Filed: 11/25/1997
• Issued: 10/19/1999
• Est. Priority Date: 11/25/1997
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: VascuSense, Inc.
• Inventors: Keilman, George W., Cimochowski, George E.
• Primary Examiner(s): Jaworski, Francis J.
• Assistant Examiner(s): Imam, Ali M.
• Application Number:
  US08/978,038
• Time in Patent Office: 693 Days
• Field of Search: 600/437, 600/438, 600/454, 600/455, 600/459, 600/462, 600/467, 600/381, 600/504, 600/505, 334/24 R
• US Class Current: 600/454
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0002 for data transfer

Abstract

A stent or graft stent energized from an external power source is provided with one or more sensors to sense a parameter, producing a signal that is transmitted outside a vessel in which the stent is implanted. At least a portion of a body of the stent or an insulated electrical conductor comprises a plurality of turns that serve as an RF antenna. An expandable mesh or helical coils that form the stent body may serve as the antenna or it may comprise a separate insulated conductor. The RF antenna receives energy electromagnetically coupled to the antenna from an external (or implanted) coil and conveys a data signal corresponding to the parameter sensed by the sensor(s) on the stent or stent graft to a monitor disposed outside the patient'"'"'s body. In one form of the invention, a plurality of conformal array transducers are used to produce and sense ultrasonic waves that are affected by a fluid flowing through a lumen of the stent. This transducer determines fluid flow or fluid velocity. In other embodiments, one or more integrated circuit (IC) sensors are used to sense other physical or biological parameters in the proximity of the stent, producing signals that are multiplexed by an electronics circuit and transmitted to the external monitor/power supply.

Claims

1. An endoluminal implant adapted to be inserted into a body passage and to determine a condition of fluid flow through the endoluminal implant within the body passage, comprising:

(a) a generally tubular shaped member having two states, including a compact state in which the member has a first cross-sectional size and an expanded state in which the member has a second cross-sectional size, said second cross-sectional size being substantially greater than said first cross-sectional size, said member including an electrical conductor;

(b) a sensor that is adapted to monitor a parameter related to fluid flow through said member, producing a signal indicative of said parameter; and

(c) a data transmitter coupled to the sensor to receive the signal, said data transmitter also being coupled to the member and adapted to transmit electromagnetic data corresponding to the signal outside the body passage in which the endoluminal implant is installed, using the electrical conductor of the member as an antenna.

2. The endoluminal implant of claim 1, further comprising an external coil adapted to be disposed proximate to the member, but outside the body passage, said external coil receiving the electromagnetic data transmitted from the member.

3. The endoluminal implant of claim 2, further comprising a monitor that is coupled to the external coil for displaying an indication of the parameter, as a function of the electromagnetic data, said monitor including a power source, said external coil electromagnetically transferring electrical power to the electrical antenna from the power source.

4. The endoluminal implant of claim 1, wherein the member comprises a spiral winding.

5. The endoluminal implant of claim 1, wherein the member comprises a helical braid.

6. The endoluminal implant of claim 1, wherein the sensor comprises an ultrasonic transmitter that produces an ultrasonic waveform directed through an interior portion of the member, said ultrasonic waveform being affected by a fluid flowing through the interior portion of the member to provide an indication of the condition of the fluid flow through the member.

7. The endoluminal implant of claim 6, wherein the ultrasonic transmitter also operates as an ultrasonic receiver, to receive an echo of the ultrasonic waveform that is reflected from the fluid flow through the member.

8. The endoluminal implant of claim 6, wherein the sensor further comprises an ultrasonic receiver that receives the ultrasonic waveform produced by the transmitter after said ultrasonic waveform is affected by the fluid flow through the member, said ultrasonic receiver producing the signal indicative of the parameter.

9. The endoluminal implant of claim 8, wherein the ultrasonic transmitter and ultrasonic receiver each comprise a conformal array of a plurality of spaced-apart, flexible transducer elements that have a curved configuration generally conforming to a curvature of the member, said conformal arrays being disposed either inside or outside of the member, and said conformal array for the ultrasonic transmitter being configured so that it produces ultrasonic waveforms, which propagate through the interior portion of the member in a predefined direction relative to a longitudinal axis of the member.

10. The endoluminal implant of claim 6, wherein the parameter is one of a fluid velocity and a fluid volumetric flow rate.

11. The endoluminal implant of claim 8, wherein the ultrasonic receiver is disposed on an opposite side of the member from where the ultrasonic transmitter is disposed.

12. The endoluminal implant of claim 1, wherein the sensor comprises a distal and a proximal pressure transducer, said distal pressure transducer being exposed to a fluid pressure of the fluid flow through an interior portion of the member adjacent to where the fluid exits the member and said proximal pressure transducer being exposed to a fluid pressure of the fluid flow through the interior portion of the member adjacent to where the fluid enters the member, said signal being indicative of a differential pressure corresponding to a difference between a proximal and a distal pressure respectively sensed by the proximal and distal pressure transducers.

13. The endoluminal implant of claim 1, wherein the endoluminal implant comprises a stent.

14. The endoluminal implant of claim 1, wherein the endoluminal implant comprises a stent graft.

15. The endoluminal implant of claim 1, wherein the electrical conductor is generally coiled about the member in a plurality of turns, to form the antenna.

16. The endoluminal implant of claim 15, wherein the member includes a break point at a joint fastened with a nonconductive material, said break point preventing the member from acting as a shorted turn that would reduce an efficacy of the antenna.

17. An endoluminal implant adapted to inserted into a body passage to monitor a parameter within the body passage, comprising:

(a) a generally tubular shaped member that is expandable within a body passage, said member including an electrical conductor that comprises an antenna;

(b) a sensor disposed on the member and adapted to sense the parameter, producing a signal indicative of said parameter; and

(c) a data transmitter affixed to the member and coupled to the sensor to receive the signal, said data transmitter being also adapted to transmit electromagnetic data corresponding to the signal through the antenna and outside the body passage in which the endoluminal implant is adapted to be installed.

18. The endoluminal implant of claim 17, wherein the antenna is adapted to electromagnetically couple to a source of electrical power that is outside the body passage, said electrical power providing an electrical current used to energize at least one of the data transmitter and the sensor.

19. The endoluminal implant of claim 17, wherein the parameter monitored by the sensor is indicative of a condition of fluid flow through an interior portion of the member, including one of flow velocity and volumetric rate of flow.

20. The endoluminal implant of claim 19, wherein the sensor comprises an ultrasonic transducer that produces an ultrasonic waveform, which is affected by a fluid flow within the endoluminal implant and the body passage.

21. The endoluminal implant of claim 17, wherein the sensor is adapted to be exposed to a fluid flowing through an interior portion of the member, the parameter monitored by the sensor comprising a physiological metabolite level in the fluid flowing through the interior portion of the member.

22. The endoluminal implant of claim 17, wherein the sensor comprises a pressure transducer that determines a pressure of the fluid flowing through an interior portion of the member.

23. The endoluminal implant of claim 17, wherein the sensor comprises a strain sensor that monitors displacement of disparate points that are spaced apart about the member.

24. The endoluminal implant of claim 17, wherein the sensor is adapted to monitor a property of organic matter disposed adjacent to or within the member to determine a type of the organic matter.

25. The endoluminal implant of claim 17, wherein the member further comprises a heater and wherein the sensor comprises a plurality of temperature sensors that determine a differential temperature between at least two of the temperature sensors.

26. The endoluminal implant of claim 25, wherein the heater heats the fluid at a modulated periodically varying rate, further comprising a filter for filtering the differential temperature, producing a filtered signal from which the signal is derived, said signal being indicative of a velocity of a fluid flow through the member.

27. The endoluminal implant of claim 17, wherein the member includes a helical element that expands outwardly to increase a size of the body passage, said electrical conductor comprising at least a portion of the helical element.

28. The endoluminal implant of claim 17, further comprising a plurality of sensors disposed on the member at a corresponding plurality of spaced-apart locations and adapted to sense the parameter at the corresponding plurality of locations or to monitor a plurality of different parameters, each of the plurality of sensors producing a signal indicative of the parameter that it senses.

29. The endoluminal implant of claim 28, wherein the member further comprises a plurality of separate electrical conductors and a plurality of data transmitters each separately connected to a different one of the electrical conductors, and wherein the plurality of sensors are each coupled to a different one of the plurality of data transmitters, each of said plurality of data transmitters transmitting the signal produced by the sensor coupled to that data transmitter through the electrical conductor connected to that data transmitter.

30. The endoluminal implant of claim 26, wherein the member further comprises a plurality of electrical conductors connected in series and a plurality of data transmitters connected to at least one of the electrical conductors, and wherein the plurality of sensors are each coupled to a different one of the plurality of data transmitters, each of said plurality of data transmitters transmitting the signal produced by the sensor coupled to that data transmitter through the electrical conductors.

31. The endoluminal implant of claim 17, wherein the electrical conductor is configured in a saddle-shaped coil around a portion of the member.

32. The endoluminal implant of claim 17, wherein the electrical conductor crosses over itself in a plurality of locations about the member and is insulated to avoid electrical conduction where it crosses over itself at least at some of said locations.

33. The endoluminal implant of claim 17, wherein the endoluminal implant comprises a stent.

34. The endoluminal implant of claim 17, wherein the endoluminal implant comprises a stent graft.

35. The endoluminal implant of claim 17, wherein the conductor is coiled about the member.

36. The endoluminal implant of claim 35, wherein the member includes a break point at a joint fastened with a nonconductive material, said break point preventing the member from acting as a shorted turn that would reduce an efficacy of the antenna.

37. A method for conveying a parameter sensed in a vicinity of an endoluminal implant, which is adapted to be moved to a treatment site inside a body passage, to an external location disposed outside the body passage, comprising the steps of:

(a) sensing the parameter within the body passage, producing a signal indicative of the parameter;

(b) connecting the signal to an electrical conductor comprising the endoluminal implant;

(c) electromagnetically coupling the signal from the electrical conductor to the external location; and

(d) receiving the signal at the external location to monitor the signal.

38. The method of claim 37, wherein the step of sensing the parameter comprises the steps of:

(a) producing an ultrasonic waveform that is directed into the body passage, said ultrasonic waveform being affected by a fluid flow through the body passage;

(b) receiving the ultrasonic waveform after it is affected by the fluid flow in the body passage; and

(c) producing the signal as a function of the ultrasonic waveform affected by the fluid flow, so that the parameter indicated by the signal is one of a fluid flow velocity and a fluid flow rate.

39. The method of claim 37, wherein the electrical conductor comprises at least a portion of a spiral element of the endoluminal implant that is adapted to apply a radially outward-directed force against deposits disposed on an interior surface of the body passage.

40. The method of claim 37, wherein the electrical conductor comprises at least a portion of a mesh that is adapted to apply a radially outward-directed force against deposits disposed on an interior surface of the body passage.

41. The method of claim 37, further comprising the step of electromagnetically coupling electrical power from the external location into the electrical conductor, said electrical power being used to provide power for electromagnetically coupling the signal from the electrical conductor to the external location.

42. The method of claim 37, wherein the step of sensing the parameter comprises the step of exposing a biochemical sensor responsive to organic substances to a biological fluid flowing through the body passage.

43. The method of claim 37, wherein the step of sensing the parameter comprises the step of providing a strain sensor to monitor stress between spaced-apart points on the endoluminal implant.

44. The method of claim 37, wherein the step of sensing the parameter comprises the step of providing a pressure transducer to monitor pressure of a fluid flowing inside the endoluminal implant.

45. The method of claim 37, wherein the step of sensing the parameter comprises the step of providing a temperature sensor to monitor a temperature in the vicinity of the endoluminal implant.

46. The method of claim 37, wherein the step of sensing the parameter comprises the step of providing a deposit and ingrowth sensor for detecting fatty deposits and tissue ingrowth within an interior portion of the endoluminal implant.

47. The method of claim 46, wherein the deposit and ingrowth sensor senses a permittivity of any tissue disposed within the interior portion of the endoluminal implant.

48. The method of claim 46, wherein the deposit and ingrowth sensor senses at least one of a resistance and a capacitance of any tissue disposed within the interior of the endoluminal implant.

49. The method of claim 37, wherein the parameter that is sensed determines a state of fluid flow through the endoluminal implant.

50. The method of claim 49, further comprising the step of providing a conformal array of ultrasonic transducer elements that extends at least partly around the endoluminal implant and is carried on a band that elastically distorts with the endoluminal implant when it is being inserted into the body passage.

51. The method of claim 37, wherein the external location is disposed proximate to and outside of a wall of the body passage.

52. The method of claim 37, wherein the external location is disposed outside a body of a patient in which the endoluminal implant is implanted.

53. The method of claim 37, wherein the endoluminal implant comprises a stent.

54. The method of claim 37, wherein the endoluminal implant comprises a stent graft.