Sheath for use with an ultrasound element

• US 7,413,556 B2
• Filed: 02/18/2003
• Issued: 08/19/2008
• Est. Priority Date: 06/29/1998
• Status: Expired due to Fees

• Current Assignee: EKOS Corporation (Boston Scientific Corporation)
• Original Assignee: EKOS Corporation (Boston Scientific Corporation)
• Inventors: Rodriguey, James E., Lichttenegger, Gary, Zhang, John, Tachibana, Katsuro
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): GRAY, PHILLIP A
• Application Number:
  US10/369,270
• Publication Number:
  US 20030216681A1
• Time in Patent Office: 2,009 Days
• Field of Search: 604 20- 22, 604/107, 604/18, 604/500, 604506-510, 604/192, 604/33, 601/2, 600/466, 600/467, 600/471, 607/97, 607/115, 607/116, 607/122
• US Class Current: 604/22
• CPC Class Codes: A61B 1/00135 Oversleeves mounted on the endoscope prior to insertion
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320073 probe
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2018/00011 with fluids
• 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: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 37/0092 using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor

Abstract

A system for delivering ultrasound energy to a treatment section in a vessel is disclosed. The system includes a sheath with a utility lumen and an energy delivery section at least partially constructed from a material which transmits ultrasound energy. The system also includes a drug delivery member having a plurality of drug delivery ports which are positioned adjacent the energy delivery section. The system further includes an elongated body including at least one ultrasound element and configured to be movably positioned within the utility lumen to transmit the ultrasound energy from the ultrasound element through the energy delivery section.

Claims

1. A method for treating a clot in a blood vessel, the method comprising:

advancing a guidewire at least partially through a clot,

advancing a sheath having a utility lumen, a distal energy delivery section, and a drug delivery member over the guidewire such that at least a portion of the distal energy delivery section is located in the clot,

withdrawing the guidewire from the utility lumen,

when at least a portion of the distal energy delivery section is located in the clot, inserting an elongated body having at least one ultrasound element into the utility lumen defined by the sheath, such that the at least one ultrasound element is positioned at least partially within the distal energy delivery section,

abutting a proximal stop portion of the elongated body against a proximal portion of the sheath, wherein the proximal stop portion comprises a conically-shaped portion of the elongated body, at least a portion of which has a larger diameter than an inner diameter of the utility lumen,

delivering a drug solution to the clot through the drug delivery member,

delivering ultrasound energy to the clot, and

moving the elongated body relative to the sheath to enhance an effect of the ultrasonic energy.

2. The method of claim 1, wherein withdrawing the guidewire from the utility lumen comprises holding the sheath stationary.

3. The method of claim 1, further comprising delivering cooling fluid to cool the at least one ultrasound element.

4. The method of claim 3, wherein delivering cooling fluid to cool the at least one ultrasound element comprises delivering cooling fluid through the utility lumen.

5. The method of claim 1, wherein advancing a guidewire through a clot comprises advancing the guidewire through a deep vein thrombus in a patient'"'"'s lower leg.

6. The method of claim 1, wherein delivering ultrasound energy to the clot involves generating ultrasound energy from electrical power delivered to the at least one ultrasound element.

7. The method of claim 1, further comprising simultaneously delivering ultrasound energy and a drug solution to at least a portion of the clot.

8. The method of claim 1, further comprising moving the at least one ultrasound element axially within the utility lumen during delivery of ultrasound energy.

9. The method of claim 1, further comprising rotating the at least one ultrasound element within the utility lumen during delivery of ultrasound energy.

10. The method of claim 1, further comprising expanding a balloon positioned on the sheath until the balloon contacts the clot.

11. A method for delivering ultrasound energy and a drug solution to a vascular occlusion, the method comprising:

advancing a sheath having a lumen through a patient'"'"'s vasculature, such that a distal end of the sheath is advanced at least partially through the vascular occlusion;

inserting an elongated body having at least one ultrasound element into the lumen;

after the distal end of the sheath is advanced at least partially through the vascular occlusion, advancing the elongated body through the lumen until the at least one ultrasound element is positioned adjacent the vascular occlusion;

abutting a proximal stop portion of the elongated body against a proximal portion of the sheath, wherein the proximal stop portion comprises a conically-shaped portion of the elongated body, at least a portion of which has a larger diameter than an inner diameter of the lumen;

delivering a drug solution to the vascular occlusion from the sheath, and

delivering ultrasound energy to the vascular occlusion.

12. The method of claim 11, further comprising:

advancing a guidewire to the vascular occlusion;

advancing the sheath over the guidewire; and

withdrawing the guidewire from the lumen.

13. The method of claim 11, further comprising moving the ultrasound element relative to the sheath.

14. A method of treating an occlusion in a blood vessel at a treatment site, the method comprising:

advancing a guidewire to the treatment site;

advancing a sheath having a lumen and a drug delivery member over the guidewire, such that at least a portion of the sheath is advanced at least partially through the occlusion;

withdrawing the guidewire from the lumen;

inserting an elongated body having at least one ultrasound element into the lumen;

advancing the elongated body through the lumen such that the at least one ultrasound element is positioned at the treatment site;

abutting a proximal stop portion of the elongated body against a proximal portion of the sheath, wherein the proximal stop portion comprises a conically-shaped portion of the elongated body, at least a portion of which has a larger diameter than an inner diameter of the lumen;

delivering a drug solution to the treatment site through the drug delivery member; and

delivering ultrasound energy to the treatment site.

15. The method of claim 14, further comprising moving the elongated body relative to the sheath.

16. A method for treating a clot in a blood vessel, the method comprising:

advancing a guidewire at least partially through a clot;

providing a sheath having a utility lumen, a proximal region having a first ultrasonic absorption, a distal energy delivery section having a second ultrasonic absorption that is lower than the first ultrasonic absorption, and a drug delivery member;

advancing the sheath over the guidewire such that at least a portion of the distal energy delivery section is located in the clot;

withdrawing the guidewire from the utility lumen;

inserting an elongated body having at least one ultrasound element into the utility lumen defined by the sheath, such that the at least one ultrasound element is positioned at least partially within the distal energy delivery section;

abutting a proximal stop portion of the elongated body against a proximal portion of the sheath, wherein the proximal stop portion comprises a conically-shaped portion of the elongated body, at least a portion of which has a larger diameter than an inner diameter of the utility lumen;

delivering a drug solution to the clot through the drug delivery member;

delivering ultrasound energy to the clot; and

moving the elongated body relative to the sheath to enhance an effect of the ultrasonic energy.

17. The method of claim 16, wherein moving the elongated body relative to the sheath further comprises moving the elongated body such that at least one ultrasound element remains within the distal energy delivery section.

18. The method of claim 16, further comprising simultaneously delivering ultrasound energy and a drug solution to at least a portion of the clot.

19. The method of claim 16, further comprising rotating the at least one ultrasound element within the utility lumen during delivery of ultrasound energy.

20. A method for treating a clot in a blood vessel, the method comprising:

advancing a guidewire at least partially through a clot;

providing a sheath having a utility lumen, a distal energy delivery section, and a drug delivery member that is hydraulically separated from the utility lumen;

advancing the sheath over the guidewire such that at least a portion of the distal energy delivery section is located in the clot;

withdrawing the guidewire from the utility lumen;

when at least a portion of the distal energy delivery section is located in the clot, inserting an elongated body having at least one ultrasound element into the utility lumen defined by the sheath, such that the at least one ultrasound element is positioned at least partially within the distal energy delivery section;

delivering a drug solution to the clot through the drug delivery member;

delivering ultrasound energy to the clot; and

moving the elongated body relative to the sheath to enhance an effect of the ultrasonic energy.

21. The method of claim 20, further comprising passing a cooling fluid through the utility lumen to cool the at least one ultrasound element.

22. The method of claim 20, further comprising simultaneously delivering ultrasound energy and a drug solution to at least a portion of the clot.

23. The method of claim 20, further comprising rotating the at least one ultrasound element within the utility lumen during delivery of ultrasound energy.

24. A method for treating a clot in a blood vessel, the method comprising:

advancing a guidewire at least partially through a clot;

providing a sheath having a utility lumen, a distal energy delivery section, and a drug delivery member having a plurality of drug delivery ports on a sheath circumferential surface;

advancing the sheath over the guidewire such that at least a portion of the distal energy delivery section is located in the clot;

withdrawing the guidewire from the utility lumen;

inserting an elongated body having at least one ultrasound element into the utility lumen defined by the sheath, such that the at least one ultrasound element is positioned at least partially within the distal energy delivery section;

delivering a drug solution to the clot through the plurality of drug delivery ports;

delivering ultrasound energy to the clot; and

moving the elongated body relative to the sheath to enhance an effect of the ultrasonic energy.

25. The method of claim 24, further comprising passing a cooling fluid through the utility lumen to cool the at least one ultrasound element.

26. The method of claim 24, further comprising simultaneously delivering ultrasound energy and a drug solution to at least a portion of the clot.

27. The method of claim 24, wherein the plurality of drug delivery ports are arrayed around the sheath in a spiral configuration.

28. A method for treating a clot in a blood vessel, the method comprising:

advancing a guidewire at least partially through a clot,

advancing a sheath having a utility lumen, a distal energy delivery section, and a drug delivery member over the guidewire such that at least a portion of the distal energy delivery section is located in the clot,

withdrawing the guidewire from the utility lumen,

when at least a portion of the distal energy delivery section is located in the clot, inserting an elongated body having at least one ultrasound element into the utility lumen defined by the sheath, such that the at least one ultrasound element is positioned at least partially within the distal energy delivery section,

delivering a drug solution to the clot through the drug delivery member,

delivering ultrasound energy to the clot, and

moving the elongated body relative to the sheath to enhance an effect of the ultrasonic energy, wherein the elongated body is not extended past a distal end of the sheath.

29. The method of claim 28, wherein the elongated body and the sheath are shaped such that the elongated body cannot be extended past a distal end of the sheath.

30. The method of claim 28, further comprising simultaneously delivering ultrasound energy and a drug solution to at least a portion of the clot.

31. The method of claim 28, further comprising rotating the at least one ultrasound element within the utility lumen during delivery of ultrasound energy.