Apparatus and methods for vibratory intraluminal therapy employing magnetostrictive transducers

• US 5,728,062 A
• Filed: 11/30/1995
• Issued: 03/17/1998
• Est. Priority Date: 11/30/1995
• Status: Expired due to Fees

• Current Assignee: PharmaSonics, Inc.
• Original Assignee: PharmaSonics, Inc.
• Inventors: Brisken, Axel F.
• Primary Examiner(s): Buiz, Michael Powell
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US08/566,740
• Time in Patent Office: 838 Days
• Field of Search: 606/169, 607/97, 604/22, 601/2, 310/26
• US Class Current: 604/22
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/22021 electric leads passing through the catheter
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61M 3/0279 Cannula; Nozzles; Tips; their connection means
• CPC Class Codes: B06B 1/08 operating with magnetostriction magnetostrictive devices per se H10N30/00

Abstract

An energy-transmitting catheter comprises a catheter body having a vibrating assembly at its distal end. The vibrating assembly comprises a magnetostrictive driver which is mechanically coupled to an interface member on the catheter for radiating energy into an environment surrounding the distal end of the catheter. Usually, the vibrating assembly further includes a tail mass, an interface member, and a spring element which together and in combination with the magnetostrictive driver define a resonant assembly for amplification of the displacement of the interface surface provided by the magnetostrictive driver. The catheter is useful for treating luminal conditions, such as vascular clot and plaque. Optionally, a therapeutic agent may be delivered through the catheter before, after, or simultaneously with the application of vibratory energy.

Claims

1. An energy-transmitting catheter, said catheter comprising:

a flexible catheter body having a proximal end and a distal end;

a magnetostrictive driver disposed near and within the distal end of the catheter body; and

an interface surface mechanically coupled to the driver so that said surface can be oscillated relative to the catheter body.

2. An energy-transmitting catheter as in claim 1, wherein the magnetostrictive driver comprises a linear element and a coil disposed coaxially about the linear element.

3. An energy-transmitting driver as in claim 2, wherein the linear element has a geometry and is composed of a material which provide oscillation at a frequency in the range from 10 kHz to 300 kHz.

4. An energy-transmitting catheter as in claim 2, wherein the linear element is composed of a polycrystalline alloy of terbium, dysprosium, and iron.

5. An energy-transmitting catheter as in claim 2, wherein the linear element is a tube or a solid rod having a length in the range from 3 mm to 12 mm and a diameter in the range from 0.5 mm to 3 mm.

6. An energy-transmitting catheter as in claim 1, wherein the magnetostrictive driver is included in a resonant spring-mass assembly.

7. An energy-transmitting catheter as in claim 6, wherein the resonant spring-mass assembly comprises

an interface member having the interface surface thereon;

a tail mass at the distal end of the catheter body; and

a spring element attached to and extending between the tail mass and the interface member with the magnetostrictive driver therebetween;

wherein the tail mass has a mass which is much greater than that of the interface member and wherein the spring element provides a spring force in combination with the elastic modulus of the magnetostrictive driver which permits resonant driving by the magnetostrictive driver.

8. An energy-transmitting catheter as in claim 7, wherein the tail mass has a mass which is at least four times the mass of the interface member.

9. An energy-transmitting catheter as in claim 8, wherein the tail mass has a mass in the range from 0.1 gm to 10 gm and the interface member has a mass in the range from 0.01 gm to 1 gm.

10. An energy-transmitting catheter as in claim 7, wherein the spring element comprises at least one rod secured at a proximal end to the tail mass and at a distal end to the interface member.

11. An energy-transmitting catheter as in claim 10, wherein the spring element consists of a single rod disposed coaxially within the catheter.

12. An energy-transmitting catheter as in claim 10, wherein the spring element comprises at least two parallel rod members disposed symmetrically about the axis of the catheter body.

13. An energy-transmitting catheter as in claim 1, wherein the interface surface includes at least a portion which extends laterally over a distal end of the catheter and which forwardly transmits longitudinal oscillations into the environment surrounding the distal end of the catheter.

14. An energy-transmitting catheter as in claim 13, wherein the interface surface has a generally convex shape.

15. An energy-transmitting catheter as in claim 1, wherein the interface surface includes at least a portion which extends axially over a lateral surface of the catheter body.

16. An energy-transmitting catheter as in claim 1, wherein the catheter body has at least one lumen for delivering a therapeutic agent therethrough.

17. An improved ultrasonic catheter of the type comprising a flexible catheter body having a peripheral surface and an ultrasonic driver near a distal end thereof, wherein the improvement comprises a magnetostrictive driver mechanically coupled to an interface surface on the catheter body, wherein the magnetostrictive driver is disposed entirely within the peripheral surface of the catheter body.

18. An improved catheter as in claim 17, wherein the magnetostrictive driver comprises a linear element and a coil disposed coaxially about the linear element.

19. An improved driver as in claim 18, wherein the linear element has a geometry and is composed of a material which provides oscillation at a frequency in the range from 10 kHz to 300 kHz.

20. An improved catheter as in claim 18, wherein the linear element is composed of a polycrystalline alloy of terbium, dysprosium, and iron.

21. An improved catheter as in claim 18, wherein the linear element is a tube or a solid rod having a length in the range from 3 mm to 12 mm and a diameter in the range from 0.5 mm to 3 mm.

22. An energy-transmitting catheter as in claim 17, wherein the magnetostrictive driver is included in a resonant spring-mass assembly.

23. An energy-transmitting catheter as in claim 22, wherein the resonant spring-mass assembly comprises

an interface member having the interface surface thereon;

a tail mass at the proximal end of the catheter body; and

a spring element attached to and extending between the tail mass and the interface member with the magnetostrictive driver therebetween;

wherein the tail mass has a mass which is much greater than that of the interface surface and wherein the spring element provides a spring force which permits resonant driving by the magnetostrictive driver.

24. An improved catheter as in claim 23, wherein the tail mass has a mass which is at least four times the mass of the interface member.

25. An improved catheter as in claim 24, wherein the tail mass has a mass in the range from 0.1 gm to 10 gm and the interface member has a mass in the range from 0.01 gm to 1 gm.

26. An improved catheter as in claim 23, wherein the spring element comprises at least one rod secured at a proximal end to the tail mass and at a distal end to the interface member.

27. An improved catheter as in claim 26, wherein the spring element consists of a single rod disposed coaxially within the catheter.

28. An improved catheter as in claim 26, wherein the spring element comprises at least two parallel rod members disposed symmetrically about the axis of the catheter body.

29. An energy-transmitting catheter as in claim 17, wherein the interface surface includes at least a portion which extends laterally over a distal end of the catheter and which forwardly transmits longitudinal oscillations into the environment surrounding the distal end of the catheter.

30. An improved catheter as in claim 29, wherein the interface surface has a generally convex shape.

31. An improved catheter as in claim 17, wherein the interface member includes at least a portion which extends axially over a lateral surface of the catheter body.

32. An improved catheter as in claim 17, wherein the catheter body has at least one lumen for delivering a therapeutic agent therethrough.

33. A method for treating an intraluminal target site, said method comprising:

providing a flexible catheter having a magnetostrictive driver disposed at and within a distal end of the catheter, wherein the magnetostrictive driver is mechanically coupled to an interface surface near the distal end of the catheter;

advancing the distal end of the catheter to an intraluminal region near the target site; and

energizing the magnetostrictive driver to oscillate the interface surface and impart vibratory energy into a fluid environment surrounding the distal end of the catheter.

34. A method as in claim 33, wherein the intraluminal target site contains a vascular stenosis.

35. A method as in claim 34, wherein the interface member surface is engaged against a vascular obstruction.

36. A method as in claim 33, wherein the interface surface is oscillated at a frequency in the range from about 10 kHz to 300 kHz.

37. A method as in claim 36, wherein the interface member is driven with a longitudinal amplitude in the range from 0.05 μ

m to 20 μ

m.

38. A method as in claim 33, wherein at least a portion of the interface surface extends laterally over the distal end of the catheter.

39. A method as in claim 38, wherein the laterally extending portion of the interface surface has an area in the range from 0.5 mm² to 20 mm².

40. A method as in claim 33, wherein at least a portion of the interface surface extends axially over a lateral surface of the catheter body.

41. A method as in claim 33, further comprising delivering a therapeutic agent through the catheter to the intraluminal lesion.

42. A method as in claim 41, wherein the therapeutic agent is delivered while ultrasonic energy is being radiated into the region.

43. A method as in claim 42, wherein the therapeutic agent is a fibrinolytic agent delivered to a vascular stenosis to treat clot.

44. A method as in claim 42, wherein the therapeutic agent is delivered to a previously treated vascular site to inhibit restenosis.