Ultrasonic sensors for monitoring the condition of a vascular graft

• US 5,807,258 A
• Filed: 10/14/1997
• Issued: 09/15/1998
• Est. Priority Date: 10/14/1997
• 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
• Assistant Examiner(s): IMAM, ALI M
• Application Number:
  US08/949,413
• Time in Patent Office: 336 Days
• Field of Search: 600/454, 600/381, 600/486, 600/459, 600/455, 600/467, 128/691, 128/692, 128/903, 623/12
• 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 5/6862 Stents
• CPC Class Codes: A61B 5/6876 Blood vessel
• 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 8/56 Details of data transmission or power supply
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: Y10S 128/903 Radio telemetry

Abstract

A parameter indicative of the status of fluid flow is remotely monitored in a vessel, a natural graft, or a synthetic graft. One or more transducers are provided either in a wall of a synthetic graft or adjacent to a vessel or natural graft to monitor the parameter. A conformal array transducer or a tilted element is used to monitor fluid flow or velocity through the graft or vessel based on the effect of the fluid on ultrasonic waves produced by the transducers. The conformal array transducer comprises a plurality of elements that curve around the graft or vessel and are excited with an input signal provided by an implantable electronics circuit, producing ultrasonic waves that propagate into the fluid flowing within the graft or vessel. Transit time or Doppler measurements are made using an appropriate number of these transducer to determine either fluid flow or velocity. Various implantable electronic circuits are provided that enable a selected transducer to be driven and to receive an ultrasonic signal or a pressure signal indicative of the status of fluid flow monitored by the transducer. The implanted electronic circuit is connected to an implanted radio frequency (RF) coil. An external coil that is connected to a power supply and monitoring console is coupled to the implanted RF coil to convey power and receive data signals from the transducer that are indicative of the parameter being monitored.

Claims

1. A graft adapted to be coupled into a patient'"'"'s vascular system, comprising:

(a) a biocompatible material formed into a generally cylindrical shape and having a circular wall defining a lumen extending along a longitudinal axis of the graft, said lumen being adapted to convey a fluid through the graft;

(b) a first transducer disposed within the wall of the graft, said first transducer producing a signal indicative of a parameter of the fluid flowing through the lumen; 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 graft.

2. The graft of claim 1, wherein the first transducer comprises a first pressure sensor and the signal is indicative of a pressure of the fluid in the lumen.

3. The graft of claim 2, further comprising a second pressure sensor disposed within the wall of the graft, said second pressure sensor also producing a signal indicative of the pressure of the fluid in the lumen, said first pressure sensor being disposed adjacent one end of the graft and said second pressure sensor being disposed adjacent an opposite end of the graft, to monitor the pressure of the fluid in the lumen at each end of the graft, a difference between the pressure of the fluid at each end of the graft providing an indication of the condition of the graft.

4. The graft 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 lumen, said ultrasonic waves being affected by the fluid flowing through the lumen, 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.

5. The graft of claim 4, wherein the parameter is one of a velocity and a flow of the fluid through the lumen of the graft, said signal indicative of the parameter being determined as a function of the fluid'"'"'s effect on the ultrasonic waves within the lumen.

6. The graft of claim 4, 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 graft and responding to the effect of the fluid in the lumen on the ultrasonic waves to produce the signal indicative of the parameter.

7. The graft of claim 6, wherein the first transducer and the second transducer are disposed on opposite sides of the graft, so that the ultrasonic waves pass through the lumen 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 lumen.

8. The graft of claim 7, wherein the plurality of elements comprising the first transducer and the second transducer are sufficiently flexible to conform to a curved shape of the wall.

9. The graft of claim 7, 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.

10. The graft of claim 7, 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.

11. The graft of claim 6, wherein the first transducer and the second transducer are spaced apart from each other along a side of the graft, further comprising a reflector disposed on an opposite side of the graft 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 lumen and are reflected back toward the second transducer by the reflector.

12. The graft of claim 6, 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 fluid in the lumen.

13. The graft of claim 12, 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.

14. The graft of claim 4, 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.

15. The graft of claim 4, 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 graft.

16. The graft of claim 15, wherein the coil is disposed within the wall of the graft.

17. The graft of claim 16, wherein the coil comprises a mesh of insulated wire formed in a plurality of loops.

18. The graft of claim 16, wherein the coil is generally saddle shaped, substantially conforming to a curvature of the wall about the longitudinal axis of the graft.

19. The graft of claim 15, wherein the coil is adapted to electromagnetically couple to an external coil that is connected to the source of energy.

20. The graft of claim 4, wherein the receiver comprises the first transducer, said radio frequency signal being applied to the plurality of element 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 fluid to determine the parameter based on a Doppler effect.

21. A method for remotely determining a condition of a graft that is disposed within a patient'"'"'s body, for an extended period of time, comprising the steps of:

(a) providing a first pressure sensor that is disposed in a wall of the graft, said first pressure sensor producing a signal indicative of a first pressure of a fluid flowing through the graft;

(b) transmitting the signal produced by the first pressure sensor to a point external to the patient'"'"'s body; and

(c) receiving the signal and producing an indication of the condition of the graft as a function of the signal.

22. The method of claim 21, further comprising the steps of:

(a) providing a second pressure sensor that is disposed in the wall of the graft, said second pressure sensor producing a signal indicative of a second pressure of a fluid flowing through the graft, said first and second pressure sensors being disposed at spaced-apart points along a length of the graft;

(b) transmitting the signal produced by the second pressure sensor to a point external to the patient'"'"'s body; and

(c) receiving the signal produced by the second pressure sensor, a difference between the first pressure and the second pressure of the fluid providing the indication of the condition of the graft.

23. A method for remotely determining a condition of a graft disposed 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, disposed in one of two locations, said two locations including;

(i) within a wall of the graft, wherein said plurality of elements are spaced apart along one side of a lumen of the graft; and

(ii) carried on a band fitted about an exterior surface of the wall, said plurality of elements being sufficiently flexible to conform to a curved shape of the wall and being spaced apart along one side of the graft;

(b) producing ultrasonic waves with the first transducer that are directed into the lumen of the graft, a fluid within the lumen affecting the ultrasonic waves;

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

(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 fluid flow through the graft, as a function of the signal.

24. The method of claim 23, wherein the first transducer emits a pulse of the ultrasonic waves, and then receives the ultrasonic waves reflected by the fluid, a Doppler effect of the fluid providing the indication of the parameter.

25. The method of claim 23, wherein a transit time of the ultrasonic waves through the graft provides the indication of the parameter.

26. The method of claim 23, further comprising the steps of:

(a) providing a second transducer that includes a plurality of elements for producing ultrasonic waves, disposed in one of two locations, said two locations including;

(i) within the wall of the graft, wherein said plurality of elements being spaced apart along one side of a lumen of the graft; and

(ii) 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 graft; and

(b) receiving the ultrasonic waves with the second transducer, and producing the signal in response thereto.

27. The method of claim 26, wherein the first and second transducers are disposed on a common side of the graft, spaced apart from each other.

28. The method of claim 27, 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 fluid, further comprising the step of correlating signals produced in response to the reflected pulses to determine the parameter.

29. The method of claim 27, further comprising the step of providing a reflector disposed on an opposite side of the graft 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 graft, been reflected by the reflector, and passed back through the graft.

30. The method of claim 26, wherein the second transducer is disposed on an opposite side of the graft 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 graft.

31. The method of claim 23, 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.

32. The method of claim 31, 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.