Implantable therapeutic device and method

• US 6,585,763 B1
• Filed: 02/23/1998
• Issued: 07/01/2003
• Est. Priority Date: 10/14/1997
• Status: Expired due to Term

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: VascuSense, Inc.
• Inventors: Cimochowski, George E., Keilman, George W.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/028,173
• Time in Patent Office: 1,954 Days
• Field of Search: 623/1.1, 623/1.42, 623/1.43, 604/891.1
• US Class Current: 623/1.42
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• 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 8/445 Details of catheter construction
• CPC Class Codes: A61B 8/4483 characterised by features of the ultrasound transducer
• CPC Class Codes: A61B 8/56 Details of data transmission or power supply
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis

Abstract

A system includes a first coil, a signal source and a first control module. The first control module regulates coupling between the signal source and the first coil. The system also includes an implantable device having a second coil coupled to a therapeutic transducer comprising an ultrasonic transducer. When the first coil is aligned with the second coil, the signal source is able to supply electrical power to the implantable device to enable the therapeutic transducer to operate. The control module is able to activate the therapeutic transducer under the control of a physician.

Claims

1. For subsequently altering a biological activity of a medication in a localized area of a body after the medication had been introduced intravascularly into the body, a vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

a first transducer coupled to a wall of said vascular graft; and

an implantable circuit for receiving electromagnetic signals, said implantable circuit coupled to said first transducer, said first transducer configured to receive a first energy from said circuit to emit a second energy having one or more frequencies and power levels to alter said biological activity of said medication in said localized area of said body subsequent to implantation of said first transducer in said body near said localized area.

2. The vascular graft of claim 1 wherein said first transducer is selected from a group consisting of the following:

an ultrasonic transducer, a plurality of light sources, an electric field transducer, an electromagnetic transducer, and a resistive heating transducer.

3. The vascular graft of claim 1 wherein said first transducer comprises a coil.

4. The vascular graft of claim 1 wherein said first transducer comprises a regular solid including piezoelectric material, and wherein a first resonance frequency, being of said one or more frequencies, is determined by a first dimension of said regular solid and a second resonance frequency, being of said one or more frequencies, is determined by a second dimension of said regular solid and further including a first electrode coupled to said regular solid and a second electrode coupled to said regular solid.

5. The vascular graft of claim 1 further comprising a second transducer coupled to said vascular graft, wherein said first and second transducers are coupled to said implantable electronic circuit and comprise ultrasonic transducers configured to provide acoustic standing waves having said one or more frequencies to alter said biological activity of said medication in a space between said first and second transducers in response to signals from said implantable electronic circuit.

6. The vascular graft of claim 1 further comprising a second transducer coupled to said vascular graft, wherein said first transducer is an ultrasonic transducer and said second transducer provides signals indicative of fluid flow through said vascular graft, said implantable circuit coupled to said second transducer.

7. The vascular graft of claim 1 wherein said implantable circuit includes a coil attached to a wall of said vascular graft and coupleable to a source of energy external to said body, to provide electrical power for energizing electrical components of said vascular graft.

8. The vascular graft of claim 7 wherein said coil is selected from a group consisting of the following:

a cylindrical coil, a simple helix, a multiple helix, a woven mesh of insulated wire formed in a plurality of helices, a substantially spiral-like structure, and a saddle-shaped coil.

9. The vascular graft of claim 7 wherein said coil is generally saddle shaped and integrated into said wall, substantially conforming to a curvature of said wall about said longitudinal axis.

10. The vascular graft of claim 7 wherein said coil is adapted to electromagnetically couple to another coil that is connected to a source of energy.

11. The vascular graft of claim 1 further comprising a battery coupled to said implantable circuit.

12. For subsequently altering a biological activity of a medication in a localized area in a body after the medication had been introduced intravascularly into the body, a vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

an apparatus including a first coil, a signal source and a first control module, said first control module regulating coupling between said signal source and said first coil;

one or more diagnostic transducers sized and constructed to be implanted into said body; and

an implantable device including a second coil coupled to a therapeutic transducer, said first coil being aligned with said second coil such that said signal source is configured to supply electrical power to said implantable device to energize said therapeutic transducer, said therapeutic transducer configured to emit energy, when energized, having one or more frequencies and one or more power levels to alter the biological activity of the medication in the localized area in the body subsequent to implantation of said therapeutic transducer into the body near the localized area.

13. The vascular graft of claim 12, wherein said implantable device includes a second control module coupled to said therapeutic transducer, said second control module configured to receive control signals and to activate said therapeutic transducer in response to said control signals.

14. The vascular graft of claim 13 wherein said second control module is configured to supply signals to said one or more diagnostic transducers, to receive signals from said one or more diagnostic transducers indicative of fluid flow through said vascular graft and to supply signals to said first control module describing a condition of said vascular graft based on said signals received from said one or more diagnostic transducers.

15. The vascular graft of claim 12 wherein said therapeutic transducer is an ultrasonic transducer configured to emit ultrasound to alter the biological activity of the medication by insonification.

16. For subsequently altering a biological activity of a medication after the medication had been introduced intravascularly into the body, a vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

an implantable electronic circuit including a multiplexer;

a therapeutic transducer coupled to said multiplexer, said therapeutic transducer configured to emit energy having one or more frequencies and one or more power levels to alter the biological activity of the medication in the localized area in the body subsequent to implantation of said therapeutic transducer into the body near the localized area; and

a diagnostic transducer coupled to said multiplexer.

17. The vascular graft of claim 16 wherein said diagnostic transducer provides signals via said multiplexer to a RF modulator contained in said implantable electronic circuit for transmission via an implantable coil that is coupled to said implantable electronic circuit, wherein said diagnostic transducer is capable of providing signals indicative of a condition of fluid flow through said vascular graft.

18. The vascular graft of claim 17, wherein said therapeutic transducer is an ultrasonic transducer configured to emit ultrasonic energy to alter the biological activity of the medication by insonification.

19. For subsequently releasing a medication encapsulated in a delivery vehicle into a localized area of a body after the encapsulated medication had been introduced intravascularly into the body, a vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

a first transducer disposed within a wall of said vascular graft; and

an implantable circuit for receiving electromagnetic signals, said implantable circuit coupled to said first transducer, said first transducer configured to receive a first energy from said implantable circuit to emit a second energy having one or more frequencies and power levels to rupture said delivery vehicle in said localized area thereby releasing said medication encapsulated in said delivery vehicle into said localized area of said body subsequent to implantation of said first transducer in said body near said localized area.

20. The vascular graft of claim 19 wherein said first transducer is selected from a group consisting of the following:

an ultrasonic transducer, a plurality of light sources, an electric field transducer, an electromagnetic transducer, and a resistive heating transducer.

21. The vascular graft of claim 19 wherein said first transducer comprises a coil.

22. The vascular graft of claim 19 wherein said first transducer comprises a regular solid including piezoelectric material, and wherein a first resonance frequency, being of the one or more frequencies, is determined by a first dimension of said regular solid and a second resonance frequency, being of the one or more frequencies, is determined by a second dimension of said regular solid, and further including a first electrode coupled to said regular solid and a second electrode coupled to said regular solid.

23. The vascular graft of claim 19, further comprising a second transducer coupled to said vascular graft, wherein said first and second transducers are coupled to said implantable circuit and comprise ultrasonic transducers configured to provide acoustic standing waves having the one or more frequencies to rupture the delivery vehicle in a space between said first and second transducers in response to signals from said implantable circuit.

24. The vascular graft of claim 19, further comprising a second transducer coupled to said vascular graft, wherein said first transducer is an ultrasonic transducer and said second transducer provides signals indicative of fluid flow through said vascular graft, said implantable circuit coupled to said second transducer.

25. The vascular graft of claim 19 wherein said implantable circuit includes a coil attached to a wall of said vascular graft and coupleable to a source of energy external to said body, to provide electrical power for energizing electrical components of said vascular graft.

26. The vascular graft of claim 25 wherein said coil is selected from a group consisting of the following:

a cylindrical coil, a simple helix, a multiple helix, a woven mesh of insulated wire formed in a plurality of helices, a substantially spiral-like structure, and a saddle-shaped coil.

27. The vascular graft of claim 25 wherein said coil is generally saddle shaped and integrated into said wall, substantially conforming to a curvature of said wall about said longitudinal axis.

28. The vascular graft of claim 25 wherein said coil is adapted to electromagnetically couple to another coil that is connected to a source of energy.

29. The vascular graft of claim 19 further comprising a battery coupled to said implantable circuit.

30. For subsequently releasing a medication encapsulated in a delivery vehicle into a localized area of a body after the encapsulated medication had been introduced intravascularly into the body, a vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

an apparatus including a first coil, a signal source and a first control module, said first control module regulating coupling between said signal source and said first coil;

one or more diagnostic transducers sized and constructed to be implanted into said body; and

an implantable device including a second coil coupled to a therapeutic transducer, said first coil aligned with said second coil such that said signal source is configured to supply electrical power to said implantable device to energize said therapeutic transducer, said therapeutic transducer configured to emit energy, when energized, having one or more frequencies and one or more power levels to rupture said delivery vehicle in said localized area thereby releasing said medication encapsulated in said delivery vehicle into said localized area of said body subsequent to implantation of said first transducer in said body near said localized area.

31. The vascular graft of claim 30, wherein said implantable device includes a second control module coupled to said therapeutic transducer, said second control module capable to receive control signals and to activate said therapeutic transducer in response to said control signals.

32. The vascular graft of claim 31 wherein said second control module is configured to supply signals to said one or more diagnostic transducers, to receive signals from said one or more diagnostic transducers indicative of fluid flow through said vascular graft and to supply signals to said first control module describing a condition of said vascular graft based on said signals received from said one or more diagnostic transducers.

33. The vascular graft of claim 30 wherein said therapeutic transducer is an ultrasonic transducer configured to emit ultrasonic energy to rupture said delivery vehicle.

34. For subsequently releasing a medication encapsulated in a delivery vehicle into a localized area of a body after the medication had been introduced intravascularly into the body, a vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

an implantable electronic circuit including a multiplexer; and

a therapeutic transducer coupled to said multiplexer, said therapeutic transducer configured to emit energy having one or more frequencies and one or more power levels to rupture said delivery vehicle in the localized area thereby releasing the medication encapsulated in said delivery vehicle into said localized area of said body subsequent to implantation of said therapeutic transducer in said body near said localized area.

35. The vascular graft of claim 34, further comprising a diagnostic transducer wherein said diagnostic transducer provides signals via said multiplexer to a RF modulator contained in said implantable electronic circuit for transmission via an implantable coil that is coupled to said implantable electronic circuit, wherein said diagnostic transducer is capable of providing signals indicative of a condition of fluid flow through said vascular graft.

36. The vascular graft of claim 35, wherein said therapeutic transducer is an ultrasonic transducer configured to emit ultrasonic energy to rupture said delivery vehicle.

37. For subsequently altering a biological response to a medication in a localized area of a body after the medication had been introduced intravascularly into the body, a vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

a first transducer disposed within a wall of said vascular graft; and

an implantable circuit for receiving electromagnetic signals, said implantable circuit coupled to said first transducer, said first transducer configured to receive a first energy from said implantable circuit to emit a second energy having one or more frequencies and power levels to alter said biological response to said medication of said portion of said body in said localized area of said body subsequent to implantation of said first transducer in said body near said localized area.

38. The vascular graft of claim 37 wherein said first transducer is selected from a group consisting of the following:

an ultrasonic transducer, a plurality of light sources, an electric field transducer, an electromagnetic transducer, and a resistive heating transducer.

39. The vascular graft of claim 37 wherein said first transducer comprises a coil.

40. The vascular graft of claim 37 wherein said first transducer comprises a regular solid including piezoelectric material, and wherein a first resonance frequency, being of the one or more frequencies, is determined by a first dimension of said regular solid and a second resonance frequency, being of the one or more frequencies, is determined by a second dimension of said regular solid, and further including a first electrode coupled to said regular solid and a second electrode coupled to said regular solid.

41. The vascular graft of claim 37 further comprising a second transducer coupled to said vascular graft, wherein said first and second transducers are coupled to said implantable circuit and comprise ultrasonic transducers configured to provide acoustic standing waves having the one or more frequencies to alter said biological activity in a space between said first and second transducers in response to signals from said implantable circuit.

42. The vascular graft of claim 37, further comprising a second transducer coupled to said vascular graft, wherein said first transducer is an ultrasonic transducer and said second transducer provides signals indicative of fluid flow through said vascular graft, said implantable circuit coupled to said second transducer.

43. The vascular graft of claim 37 wherein said implantable circuit includes a coil attached to a wall of said vascular graft and coupleable to a source of energy external to said body, to provide electrical power for energizing electrical components of said vascular graft.

44. The vascular graft of claim 43 wherein said coil is selected from a group consisting of the following:

a cylindrical coil, a simple helix, a multiple helix, a woven mesh of insulated wire formed in a plurality of helices, a substantially spiral-like structure, and a saddle-shaped coil.

45. The vascular graft of claim 43 wherein said coil is generally saddle shaped and integrated into said wall, substantially conforming to a curvature of said wall about said longitudinal axis.

46. The vascular graft of claim 43 wherein said coil is adapted to electromagnetically couple to another coil that is connected to a source of energy.

47. The vascular graft of claim 37 further comprising a battery coupled to said implantable circuit.

48. For subsequently altering a biological response to a medication in a localized area of a body after the medication had been introduced intravascularly into the body, a vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

an apparatus including a first coil, a signal source and a first control module, said first control module regulating coupling between said signal source and said first coil;

one or more diagnostic transducers coupled to a vascular graft sized and constructed to be implanted into said body; and

an implantable device including a second coil coupled to a therapeutic transducer said first coil being aligned with said second coil such that said signal source is configured to supply electrical power to said implantable device to energize said therapeutic transducer, said therapeutic transducer configured to emit energy, when energized, having one or more frequencies and one or more power levels to alter said biological response to said medication of said portion of said body in said localized area in said body subsequent to implantation of said therapeutic transducer in said body near said localized area.

49. The vascular graft of claim 48, wherein said implantable device includes a second control module coupled to said therapeutic transducer, said second control module capable to receive control signals and to activate said therapeutic transducer in response to said control signals.

50. The vascular graft of claim 49 wherein said second control module is configured to supply signals to said one or more diagnostic transducers, to receive signals from said one or more diagnostic transducers indicative of fluid flow through said vascular graft and to supply signals to said first control module describing a condition of said vascular graft based on said signals received from said one or more diagnostic transducers.

51. The vascular graft of claim 48 wherein said therapeutic transducer is an ultrasonic transducer configured to emit ultrasonic energy to alter said biological response to said medication.

52. For altering a biological response to a medication of a portion of a body in a localized area of said body, a vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

an implantable electronic circuit including a multiplexer;

a therapeutic transducer coupled to said multiplexer, said therapeutic transducer configured to emit energy having one or more frequencies and one or more power levels to alter said biological response to said medication of said portion of said body in said localized area of said body subsequent to implantation of said therapeutic transducer into said body near said localized area;

a diagnostic transducer coupled to said multiplexer; and

a vascular graft coupled to said diagnostic transducer.

53. The vascular graft of claim 52 wherein said diagnostic transducer provides signals via said multiplexer to a RF modulator contained in said implantable electronic circuit for transmission via an implantable coil that is coupled to said implantable electronic circuit, wherein said diagnostic transducer is capable of providing signals indicative of a condition of fluid flow through said vascular graft.

54. The vascular graft of claim 53, wherein said therapeutic transducer is an ultrasonic transducer configured to emit ultrasonic energy to alter said biological response to said medication of said portion of said body.

55. A vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

a first transducer coupled to a wall of said vascular graft; and

an implantable circuit for receiving electromagnetic signals, said implantable circuit coupled to said first transducer, said first transducer configured to receive a first energy from said circuit to emit a second energy having one or more frequencies and power levels to subsequently alter a biological activity of a medication in a localized area of a body after the medication had been introduced intravascularly into said body, subsequent to implantation of said first transducer in said body near said localized area.

56. A vascular graft comprising:

a biocompatible material formed into a shape having a longitudinal axis to enclose a lumen disposed along said longitudinal axis of said shape, said lumen positioned to convey fluid through said vascular graft;

a first transducer disposed within a wall of said vascular graft; and

an implantable circuit for receiving electromagnetic signals, said implantable circuit coupled to said first transducer, said first transducer configured to receive a first energy from said implantable circuit to emit a second energy having one or more frequencies and power levels to subsequently rupture a delivery vehicle containing an encapsulated medication in a localized area of a body after the encapsulated medication had been introduced intravascularly into said body, to release said encapsulated medication into said localized area of said body, subsequent to implantation of said first transducer in said body near said localized area.