System of implantable ultrasonic emitters for preventing restenosis following a stent procedure

• US 7,857,766 B2
• Filed: 06/20/2005
• Issued: 12/28/2010
• Est. Priority Date: 06/20/2005
• Status: Active Grant

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Mandell, Lee J., Lasater, Brian J.
• Primary Examiner(s): Winakur; Eric F
• Assistant Examiner(s): Fernandez; Katherine L
• Application Number:
  US11/158,166
• Publication Number:
  US 20060287598A1
• Time in Patent Office: 2,017 Days
• Field of Search: 128/899, 623/1.36, 623/1.21, 623/1.11, 623/1.1, 600/443, 600/437, 600/407, 600/439, 601/2
• US Class Current: 600/439
• CPC Class Codes: A61B 17/22012 in direct contact with, or very close to, the obstruction or concrement for removing obstructions in blood vessels by laser A61B18/245
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/30668 Means for transferring electromagnetic energy to implants
• CPC Class Codes: A61F 2250/0001 Means for transferring electromagnetic energy to implants

Abstract

A system and method that minimizes plaque accumulation on a stent and thereby restenosis that could require a subsequent invasive medical procedure following implantation of the stent in a patient. A plurality of electrically-powered, biocompatible devices, implantable via injection, are positioned within the patient proximate to the stent and under control of a externally-placed controller are commanded to emit ultrasonic waves corresponding to the mechanical resonance of the stent. By controlling the frequency and the relative phases of the ultrasonic waves, the accumulation of plaque on the stent can thus be minimized.

Claims

1. A system for preventing restenosis following placement of a stent in a vessel of a patient, said system comprising:

two or more implantable devices configured for implantation via injection in sites proximate to the stent, wherein each said implantable device is electrically powered and comprises controller circuitry and an ultrasonic emitter configured to emit an ultrasonic wave at a determined frequency, said ultrasonic emitter activated by said controller circuitry in response to an externally-provided command signal that is individually addressable to each of said implantable devices, said two or more implantable devices configured for wireless communication; and

an externally-placed control device in wireless communication with said two or more implantable devices for providing said addressable command signals to each of said implantable devices to control the relative phase of each of said emitted ultrasonic waves to enable said ultrasonic waves to constructively add to induce mechanical vibrations in the stent to minimize plaque buildup on the stent.

2. The system of claim 1 wherein said vessel of a patient is a blood vessel.

3. The system of claim 1 wherein said vessel of a patient is a ureter.

4. The system of claim 1 wherein the determined frequency is selectable to correspond to the mechanical resonant frequency of the stent.

5. The system of claim 1 wherein said externally-placed control device additionally includes coupling to two or more EKG leads suitable for placement on the patient to enable said addressable command signals to be synchronized to heart beats of the patient.

6. The system of claim 1 additionally comprising an ultrasound imaging device for determining the mechanical resonant frequency of the stent in response to said induced mechanical vibrations produced by said ultrasonic waves.

7. The system of claim 6 wherein said ultrasound imaging device is coupled to said externally-placed control device to automatically determine the mechanical resonant frequency of the stent.

8. The system of claim 7 wherein said ultrasound imaging device coupled to said externally-placed control device additionally automatically determines the relative phase relationship between the ultrasonic waves emitted by said implantable devices that maximizes the amplitude of mechanical vibrations in the stent.

9. The system of claim 1 additionally comprising an ultrasound imaging device for determining when the phase relationship between the emitted ultrasonic waves maximizes the amplitude of mechanical vibrations in the stent.

10. The system of claim 9 wherein said ultrasound imaging device is coupled to said externally-placed control device to automatically determine the relative phase relationship between the ultrasonic waves emitted by said implantable devices that maximizes the amplitude of mechanical vibrations in the stent.

11. The system of claim 1 wherein said implantable devices are configured to generate an electrical signal for powering said implantable device in response to an externally-provided AC magnetic field.

12. The system of claim 11 wherein said externally-placed control device additionally produces said externally-provided AC magnetic field.

13. The system of claim 12 wherein said externally-provided AC magnetic field is amplitude modulated with said externally-provided addressable command signals and each said implantable device includes a receiving portion for responding to said addressable command signals.

14. The system of claim 13 wherein said command signal includes instructions to determine parameters of said ultrasonic waves selected from the set of the frequency, amplitude, and phase of said ultrasonic waves.

15. The system of claim 1 wherein said implantable devices are each contained within a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm.

16. A method of preventing restenosis following placement of a stent in a vessel of a patient, said method comprising the steps of:

implanting two or more implantable devices via injection in sites proximate to the stent, wherein each said implantable device is electrically powered and comprises controller circuitry and an ultrasonic emitter configured to emit an ultrasonic wave at a determined frequency, said ultrasonic emitter activated by said controller circuitry in the implantable device in response to an externally-provided command signal that is individually wirelessly addressable to each of said implantable devices, said two or more implantable devices configured for wireless communication;

positioning a transducer proximate to said one or more implanted devices, wherein said transducer is coupled to an external controller; and

instructing said external controller to cause said transducer to emit a wireless command signal to said controller circuitry in the implanted devices to minimize accumulation of plaque on the implanted stent by controlling parameters of said ultrasonic waves emitted by the ultrasonic emitter of each of said implanted devices, wherein said parameters are selected from the set of amplitude, frequency, and phase of said emitted ultrasonic waves.

17. The method of claim 16 additionally comprising the steps of:

sensing the EKG of the patient to determine the relative position of the patient'"'"'s heart; and

synchronizing said command signals to said sensed EKG to cause said implantable devices to emit said ultrasonic waves at a predetermined relative position of the patient'"'"'s heart.

18. The method of claim 17 additionally comprising the steps of:

sensing the ultrasonic energy accumulated by the stent using an ultrasound imager; and

causing said command signal to adjust said determined ultrasound frequency emitted by said implantable devices to maximize the sensed ultrasonic energy accumulated by the stent.

19. The method of claim 16 additionally comprising the steps of:

sensing the ultrasonic energy accumulated by the stent using an ultrasound imager; and

causing said command signal to adjust said determined ultrasonic frequency emitted by said implantable devices to maximize the sensed ultrasonic energy accumulated by the stent.

20. The method of claim 19 additionally comprising the step of causing said command signal to adjust the relative phases of the ultrasonic waves emitted by said implantable devices to maximize the sensed ultrasonic energy accumulated by the stent.

21. The method of claim 16 additionally comprising the steps of:

sensing the ultrasonic energy accumulated by the stent using an ultrasound imager; and

causing said command signal to adjust the relative phases of the ultrasonic waves emitted by said implantable devices to maximize the sensed ultrasonic energy accumulated by the stent.

22. The method of claim 16 wherein said step of instructing said controller to cause said transducer to emit a command signal to said implantable devices additionally comprises, following placement of the stent in a blood vessel of a patient, the steps of:

determining the resonant frequency of the stent; and

determining relative phase offsets between said implantable devices to maximize ultrasonic energy accumulated by the stent.

23. The method of claim 16 additionally comprising the steps of:

implanting an extravascular structure proximate to the stent implanted within a blood vessel of the patient; and

wherein

the step of instructing said external controller to cause said transducer to emit a command signal to said controller circuitry in the implantable devices to minimize accumulation of the plaque on the implanted stent additionally comprises the step of focusing said ultrasonic waves toward said extravascular structure which in turn imparts its ultrasonic energy to the implanted stent.