Ultrasonic sensors for monitoring the condition of flow through a cardiac valve

• US 6,398,734 B1
• Filed: 08/12/1999
• Issued: 06/04/2002
• Est. Priority Date: 10/14/1997
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: VascuSense, Inc.
• Inventors: Keilman, George W., Cimochowski, George E.
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US09/373,445
• Time in Patent Office: 1,027 Days
• Field of Search: 600/437, 600/439, 600/454-456, 600/459, 600/504, 623/222, 623/900
• US Class Current: 600/454
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/6876 Blood vessel
• CPC Class Codes: A61B 5/6884 Clamps or clips
• CPC Class Codes: A61B 8/04 Measuring blood pressure
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4227 characterised by straps, belts, cuffs or braces
• CPC Class Codes: A61B 8/4472 Wireless probes
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections

Abstract

A parameter indicative of the condition of a cardiac valve is determined by monitoring blood flow and/or velocity in a vessel that is coupled to the cardiac valve or in a chamber adjacent to an artificial cardiac valve. One or more ultrasonic transducers are provided either in a wall or a cuff disposed about a cardiac vessel to monitor the parameter in regard to a natural or artificial cardiac valve, or in a support sewing ring of an artificial cardiac valve. A conformal array transducer or a tilted element is used to monitor fluid flow or velocity based on the effect of the blood on ultrasonic waves produced by the transducers. The conformal array transducer comprises a plurality of elements that are excited with an input signal provided by an implantable electronics circuit, producing ultrasonic waves. Transit time or Doppler measurements are made using an appropriate number of these transducers to determine either blood volumetric flow or velocity. Various implantable electronic circuits are disclosed that enable a transducer to be driven and to receive an ultrasonic signal indicative of the status of blood flow and thus, the condition of the cardiac valve. A radio frequency (RF) coil is coupled to an external coil. The external coil is connected to a power supply and monitoring console, conveying power to the ultrasonic transducers and receiving data signals that enable the condition of the cardiac valve to be determined.

Claims

1. A band adapted to be applied externally around a cardiac vessel in a vicinity of a cardiac valve to monitor a condition of the cardiac valve that controls blood flow through the cardiac vessel in a patient'"'"'s body, comprising:

(a) a biocompatible material that is sufficiently elastomeric to be wrapped around said cardiac vessel, forming a cuff;

(b) a first transducer disposed within the wall of the cuff, said first transducer producing a signal indicative of a parameter of the blood flowing through the cardiac vessel, and thus, indicative of a condition of the cardiac valve; and

(c) a coil coupled to the first transducer for conveying the signal to a point external to the patient'"'"'s body, for use in evaluating a condition of the cardiac valve, as a function of the parameter of the blood flowing through the cardiac vessel.

2. The band of claim 1, wherein said first transducer includes a plurality of elements formed on a piezoelectric substrate, which when excited by a radio frequency signal, emit ultrasonic waves that propagate into the cardiac vessel, said ultrasonic waves being affected by the blood flowing through the cardiac vessel, further comprising a receiver of the ultrasonic waves that produces the signal indicative of the parameter, said receiver being coupled to the coil so that the signal produced by the receiver is conveyed outside the patient'"'"'s body.

3. The band of claim 2, wherein the parameter is one of a velocity and a flow of the blood through the cardiac vessel, said signal indicative of the parameter being determined as a function of the blood'"'"'s effect on the ultrasonic waves within the cardiac vessel.

4. The band of claim 2, wherein the receiver comprises a second transducer that includes a plurality of elements formed on a piezoelectric substrate, said second transducer being disposed within the wall of the cuff and responding to the effect of the blood in the cardiac vessel on the ultrasonic waves to produce the signal indicative of the parameter.

5. The band of claim 4, wherein the first transducer and the second transducer are disposed on opposite sides of the cuff, so that the ultrasonic waves pass through the cardiac vessel when traveling from the first transducer to the second transducer, said signal produced by the second transducer providing an indication of a transit time of the ultrasonic waves through the cardiac vessel.

6. The band of claim 5, wherein the plurality of elements comprising the first transducer and the second transducer are sufficiently flexible to conform to a curved shape of an exterior surface of a cardiac vessel.

7. The band of claim 5, wherein the plurality of elements comprising the first transducer are divided into a first portion and a second portion, elements comprising the first portion being interdigitally dispersed among elements comprising the second portion and adapted to couple to the radio frequency signal in one polarity, the elements comprising said second portion being adapted to couple to the radio frequency signal with an opposite polarity, so that the ultrasonic waves produced by the elements comprising the second portion are phase shifted by about 180°

relative to the ultrasonic waves produced by the elements comprising the first portion.

8. The band of claim 5, further comprising a phase shifter, wherein the elements comprising the first transducer are divided into four portions arranged in an ordered array in which each successive element is from a different one of the four portions, taken in order, the radio frequency signal being applied to the phase shifter, and a phase shifted signal produced by the phase shifter being applied to at least two of each successive four elements to provide about a 90°

phase difference between the ultrasonic waves emitted by successive elements, so that the ultrasonic waves that are emitted by the first transducer in one direction are substantially canceled due to a destructive interference.

9. The band of claim 4, wherein the first transducer and the second transducer are spaced apart from each other along a side of the cuff, further comprising a reflector disposed on an opposite side of the cuff from the first transducer and generally opposite a point between the first transducer and the second transducer, so that the ultrasonic waves from the first transducer pass through the cardiac vessel and are reflected back toward the second transducer by the reflector.

10. The band of claim 4, wherein the first transducer and the second transducer alternately function as an emitter and as a receiver of the ultrasonic waves during successive time intervals, said radio frequency signal being coupled to the plurality of elements comprising the second transducer when it functions as the emitter, while the plurality of elements comprising the first transducer are then coupled to the coil and produce the signal indicative of the parameter in response to the ultrasonic waves affected by the blood in the cardiac vessel.

11. The band of claim 10, further comprising a multiplexer that is used for alternately coupling the first and the second transducers to the radio frequency signal and to the coil.

12. The band of claim 2, wherein the frequency of the radio frequency signal is controlled to determine a beam angle along which the ultrasonic waves are emitted by the first transducer.

13. The band of claim 2, wherein the coil is adapted to couple to a source of energy that is external to the patient'"'"'s body, to provide electrical power for energizing electrical components of the band.

14. The band of claim 13, wherein the coil is adapted to electromagnetically couple to an external coil that is connected to the source of energy.

15. The band of claim 2, wherein the receiver comprises the first transducer, said radio frequency signal being applied to the plurality of elements as a pulse, causing the plurality of ultrasonic waves to be emitted as a pulse, said plurality of elements comprising the first transducer then receiving an echo of the pulse of the ultrasonic waves that is reflected from the blood to determine the parameter based on a Doppler effect.

16. The band of claim 1, wherein the coil is disposed within the wall of the cuff.

17. The band of claim 1, wherein the coil comprises an insulated wire formed in a plurality of loops.

18. The band of claim 1, wherein the coil is adapted to be implanted under a dermal layer in the patient'"'"'s body, separate from the band and electrically coupled thereto.

19. A system for monitoring a parameter indicative of a condition of a cardiac valve, said system comprising:

(a) a carrier band that is adapted to couple about a cardiac vessel through which blood flows either to or from the cardiac valve, so that the carrier band is in close proximity to at least one side of the cardiac vessel;

(b) a first transducer having at least one conformal element disposed on the carrier band, said at least one conformal element being sufficiently flexible and shaped so that it is adapted to curve about the cardiac vessel, conforming to its shape, said first transducer being adapted to couple to a radio frequency signal and producing ultrasonic waves when excited by the radio frequency signal, said ultrasonic waves being emitted from said at least one conformal element and being directed into an interior of the cardiac vessel; and

(c) a receiver disposed to receive the ultrasonic waves after they have propagated at least partially through the cardiac vessel, said receiver producing a signal indicative of an effect on the ultrasonic waves due to the blood in the cardiac vessel and thus, indicative of a parameter relating to a flow of the blood through the cardiac vessel and of a condition of the cardiac valve.

20. The system of claim 19, wherein the ultrasonic waves are emitted as a pulse, the first transducer alternately comprising an emitter of the pulse of the ultrasonic waves, and then comprising the receiver, said pulse of ultrasonic waves being reflected from the blood in the cardiac vessel back toward the first transducer.

21. The system of claim 19, wherein the carrier band is formed of a material adapted to be disposed within a patient'"'"'s body, said system being used to monitor the flow of the blood through the cardiac vessel to determine whether the cardiac valve is functioning properly.

22. The system of claim 21, further comprising a second transducer having at least one conformal element on the carrier band, said at least one conformal element being sufficiently flexible and shaped so that it is adapted to curve about the cardiac vessel, conforming to a shape of the cardiac vessel.

23. The system of claim 22, wherein said second transducer is adapted to couple to the radio frequency signal and produces ultrasonic waves when excited by the radio frequency signal, said first transducer and said second transducer alternately interchangeably functioning as the receiver and as an emitter of the ultrasonic waves during successive time intervals.

24. The system of claim 22, wherein the first transducer and the second transducer are disposed on opposite sides of the carrier band when it is fitted about the cardiac vessel, said second transducer comprising the receiver of the ultrasonic waves emitted by the first transducer, said parameter being determined as a function of a transit time for the ultrasonic waves to pass through the cardiac vessel.

25. The system of claim 22, wherein said at least one conformal element of each of the first transducer and the second transducer are shaped like segments of a sine wave having a period substantially equal to a circumference of the cardiac vessel.

26. The system of claim 25, wherein an amplitude of the sine wave having segments relating to the shape of said at least one conformal element of each of the first and the second transducers substantially determines a beam angle of the ultrasonic waves.

27. The system of claim 22, wherein the carrier band comprises a substrate of a piezoelectric material on which a plurality of electrodes are formed to define conformal elements of the first and the second transducers.

28. The system of claim 27, wherein the piezoelectric material is uniformly polarized, every fourth electrode of the plurality of electrodes being coupled together.

29. The system of claim 27, wherein the piezoelectric material is zone polarized, every other electrode that comprises the plurality of electrodes being coupled together.

30. The system of claim 27, wherein the carrier band further comprises an acoustic backing layer that encompasses the plurality of electrodes formed on the piezoelectric material.

31. The system of claim 27, wherein the carrier band further comprises a radio frequency shield encompassing the plurality of electrodes formed on the piezoelectric material.

32. The system of claim 19, wherein the ultrasonic waves emitted by successive elements of the first transducer are 90°

out of phase, so that the ultrasonic waves emitted in one direction are canceled due to a destructive interference.

33. The system of claim 19, further comprising a coil adapted to receive power from an external source and to provide an electrical current that is used for energizing components of the system.

34. The system of claim 33, wherein the coil is disposed within a wall of the carrier band.

35. The system of claim 33, wherein the coil is disposed on the carrier band.

36. The system of claim 33, further comprising a power supply, and a multiplexer, both being adapted to be internally disposed within the patient'"'"'s body, said multiplexer alternately coupling the coil to the receiver and then to the power supply, so that power from the external source is supplied to the power supply when the coil is coupled to the power supplied by the multiplexer, and the signal produced by the receiver is supplied to the coil when the coil is coupled to the receiver.

37. The system of claim 19, wherein opposite ends of the carrier band are adapted to be joined after the carrier band is wrapped around the cardiac vessel.

38. The system of claim 19, wherein the parameter comprises at least one of a volumetric flow and a velocity of blood flowing through the cardiac vessel and the cardiac valve, any defects in the cardiac valve being evident in the parameter.

39. A method for remotely determining a condition of a cardiac valve within a patient'"'"'s body, for an extended period of time, comprising the steps of:

(a) providing a first transducer that includes a plurality of elements for producing ultrasonic waves, carried on a band fitted about an exterior surface of the cardiac vessel, said plurality of elements being sufficiently flexible to conform to a curved shape of the cardiac vessel and being spaced apart along one side of the band;

(b) producing ultrasonic waves with the first transducer that are directed into the cardiac vessel, blood within the cardiac vessel affecting the ultrasonic waves;

(c) receiving the ultrasonic waves after they have been affected by the blood in the cardiac vessel, and producing a signal in response thereto that is indicative of a parameter related to the flow of the blood through the cardiac vessel;

(d) transmitting the signal to a point outside the patient'"'"'s body; and

(e) producing an indication of the parameter and thus of the condition of the cardiac valve, as a function of the signal.

40. The method of claim 39, wherein the first transducer emits a pulse of the ultrasonic waves, and then receives the ultrasonic waves reflected by the blood, a Doppler effect of the blood providing the indication of the parameter.

41. The method of claim 39, wherein a transit time of the ultrasonic waves through the cardiac vessel provides the indication of the parameter.

42. The method of claim 41, further comprising the steps of:

(a) providing a second transducer that includes a plurality of elements for producing ultrasonic waves, carried on the band, said plurality of elements being sufficiently flexible to conform to the curved shape of the wall and being spaced apart along a side of the band;

(b) receiving the ultrasonic waves with the second transducer; and

(c) producing the signal in response to the ultrasonic waves that are received with the second transducer.

43. The method of claim 42, wherein the first and second transducers are disposed on a common side of the band, spaced apart from each other.

44. The method of claim 43, wherein the first and the second transducers each emit pulses of ultrasonic waves and each receive reflected pulses of the ultrasonic waves back from the blood, further comprising the step of correlating signals produced in response to the reflected pulses to determine the parameter.

45. The method of claim 43, further comprising the step of providing a reflector disposed on an opposite side of the band from that along which the first and the second transducers are disposed, wherein the second transducer receives the ultrasonic waves produced by the first transducer that have passed through the cardiac vessel, been reflected by the reflector, and passed back through the cardiac vessel.

46. The method of claim 44, wherein the second transducer is disposed on an opposite side of the band from the first transducer, said second transducer receiving the ultrasonic waves produced by the first transducer and producing the signal which varies as a function of a transit time through the cardiac vessel.

47. The method of claim 39, wherein the step of transmitting comprises the step of electromagnetically coupling the signal from a coil implanted within the patient'"'"'s body to an external coil disposed outside the patient'"'"'s body.

48. The method of claim 47, further comprising the step of electromagnetically coupling electrical energy from an external power source that is connected to the external coil to the coil implanted within the patient'"'"'s body, to supply electrical power to at least the first transducer.

49. The method of claim 39, wherein the band is formed as a cylinder, further comprising the steps of cutting the band;

wrapping the band around the cardiac vessel; and

reconnecting ends of the band so that the band substantially encircles the cardiac vessel.

50. The method of claim 39, wherein the parameter comprises at least one of a volumetric flow of blood, and a velocity of blood flowing through the cardiac vessel.

51. The method of claim 39, further comprising the steps of cutting the cardiac vessel;

slipping the band over the cut cardiac vessel, and reconnecting cut ends of the cardiac vessel.

52. The method of claim 39, further comprising the step of remotely monitoring the condition of the cardiac valve while a patient in which it is disposed is ambulatory.

53. An artificial cardiac valve that monitors blood flow therethrough to determine a condition of said cardiac valve after it is mounted in a patient'"'"'s heart, comprising:

(a) a movable valve element, which in a first position, enables blood to flow in a desired direction through the artificial cardiac valve, but in a second position, blocks blood flow therethrough in an opposite direction;

(b) a generally annular support for the valve element;

(c) a flow transducer disposed within the support and oriented to monitor flow through the artificial cardiac valve within a portion of a chamber in a patient'"'"'s heart after the artificial cardiac valve is mounted in said heart, said flow transducer producing a signal indicative of blood flow through the artificial cardiac valve during a cardiac cycle, said signal being indicative of a condition of the artificial cardiac valve and being adapted to couple through a radio link to an external monitoring site that is outside the patient'"'"'s body to enable the condition of the artificial cardiac valve to be monitored at least from time to time;

(d) an additional flow transducer disposed within the support and oriented to monitor flow through the artificial cardiac valve within a different portion of said chamber, producing an additional signal that is adapted to couple with the external monitoring device through the radio link and which is further indicative of blood flow through the artificial cardiac valve, to better determine said blood flow and thereby, to better determine the condition of the artificial cardiac valve; and

(e) a multiplexer that is coupled to the flow transducer and to the additional flow transducer, said multiplexer being adapted to selectively alternatively couple the flow transducer and the additional flow transducer to the radio link.

54. The artificial cardiac valve of claim 53, further comprising an antenna coil disposed within the support, said antenna coil being used to couple energy from an external source into the flow transducer to energize it and to transmit the signal produced by the flow transducer to the external monitoring device.

55. The artificial cardiac valve of claim 53, further comprising an implanted antenna coil that is adapted to be disposed within the patient'"'"'s body, outside the patient'"'"'s heart and apart from the flow transducer, but connected thereto, said implanted antenna coil being used to couple energy from an external source into the flow transducer to energize it and to transmit the signal produced by the flow transducer to the external monitoring device.

56. The artificial cardiac valve of claim 53, wherein the flow transducer produces range-gated pulsed Doppler ultrasonic pulses that are usable to determine blood flow velocity through the cardiac valve.

57. The artificial cardiac valve of claim 53, wherein the flow transducer and the additional flow transducer produce range gated ultrasonic pulses that are usable to determine blood flow along a line bisecting an angle between ultrasound beams produced by the flow transducer and the additional flow transducer, respectively.

58. The artificial cardiac valve of claim 57, wherein the flow transducer and the additional flow transducer are disposed on the support so that when the artificial cardiac valve is mounted in a patient'"'"'s heart, the ultrasound beams are directed into a cardiac chamber disposed upstream from the artificial cardiac valve.

59. A method for monitoring blood flow through an artificial cardiac valve to determine a condition of said valve, comprising the steps of:

(a) providing an artificial cardiac valve that includes at least one flow transducer disposed therein;

(b) mounting the artificial cardiac valve within a patient'"'"'s heart;

(c) with said at least one flow transducer, producing ultrasonic pulses directed into a cardiac chamber adjacent to the artificial cardiac valve;

(d) monitoring blood flow through the cardiac valve with said at least one flow transducer, producing a flow signal; and

(e) transmitting the flow signal to an external receiver over a radio link, said flow signal indicating the blood flow through the artificial cardiac valve, enabling a condition of the artificial cardiac valve to be determined.

60. The method of claim 59, further comprising the steps of:

(a) providing an antenna coil that is coupled to said at least one flow transducer;

(b) transmitting the flow signal to the external receiver via the antenna coil; and

(c) receiving electrical power to energize said at least one flow transducer from an external transmitter through the antenna coil.

61. The method of claim 60, wherein the antenna coil is disposed in the artificial cardiac valve.

62. The method of claim 61, further comprising the step of processing the ultrasonic pulses as a plurality of range-gated Doppler pulses.

63. The method of claim 62, further comprising the step of using the range-gated Doppler pulses to monitor blood flow velocity through the artificial cardiac valve, for use in determining a condition of the artificial cardiac valve.

64. A band adapted to be applied externally around a tubular passage in a patient'"'"'s body to monitor a fluid flow through the tubular passage, comprising:

(a) a biocompatible material that is sufficiently elastomeric to be wrapped around the tubular passage, forming a cuff;

(b) a first transducer disposed within the wall of the cuff, said first transducer producing a signal indicative of a parameter of the fluid flowing through the tubular passage; and

(c) a coil coupled to the first transducer for conveying the signal to a point external to the patient'"'"'s body, for use in evaluating a condition of the patient'"'"'s body, as a function of the parameter of the fluid flowing through the tubular passage.