Ultrasonic angioplasty-atherectomy catheter and method of use

• US 6,454,737 B1
• Filed: 06/25/1999
• Issued: 09/24/2002
• Est. Priority Date: 01/11/1991
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Nita, Henry, Mills, Timothy
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Lam, Ann Y
• Application Number:
  US09/344,766
• Time in Patent Office: 1,187 Days
• Field of Search: 604/22, 604/27, 604/28, 604/35, 604/48, 604/500, 604/93.01, 604/264, 606/171, 606/169, 128/660.01, 128/663.01, 601/2.4, 607/97, 607/122
• US Class Current: 604/22
• 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 18/245 for removing obstructions in blood vessels or calculi
• CPC Class Codes: A61B 2017/00101 using an array of thermosensors
• CPC Class Codes: A61B 2017/00849 with respect to tissue, e.g. hollow organs
• CPC Class Codes: A61B 2017/22014 the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire not applied in A61B17/22012
• CPC Class Codes: A61B 2017/22039 eccentric
• CPC Class Codes: A61B 2017/22041 outside the catheter
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61F 2002/30092 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0042 using a fluid, e.g. circulating
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

An ultrasonic device and method for removing obstructive matter from an anatomical structure or passageway (e.g., blood vessel). The device comprises an elongate pliable catheter having a distal tip member attached to the distal end thereof, and an ultrasound transmission member which extends longitudinally therethrough to carry ultrasound from the proximal end of the catheter to the distal tip member. The distal tip member has a concave indentation formed in the distal surface thereof, and at least one inlet passageway extending therethrough in communication with a catheter lumen to facilitate suctioning of severed matter which becomes located within the concave indentation of the distal tip. The device may further incorporate means for infusing fluid (e.g., irrigation fluid, medicaments) separately or concurrently with the aspiration of the severed obstructive matter.

Claims

1. An ultrasonic device for removing obstructive matter from a tortuous anatomical passageway, said device comprising:

an elongate pliable catheter body having a proximal end, a distal end and further comprising;

an outer tube having a proximal end, a distal end and a hollow lumen of a luminal diameter extending longitudinally therethrough; and

an inner tube having an outer surface of an outer diameter, a proximal end, a distal end, and a hollow lumen extending longitudinally therethrough;

the outer diameter of said inner tube being smaller than the luminal diameter of said outer tube, and said innter tube being disposed within the lumen of said outer tube;

a distal tip member fixedly attached to the distal end of said catheter body for engaging the obstuctive matter, wherein said distal tip member is in abutting contact with the distal ends of said inner and outer tubes, said distal tip member having a distal surface;

a solid, flexible ultrasound transmission member extending longitudinally through said catheter body to transmit ultrasound from an ultrasound source located externally to said catheter body, through said catheter body, to said distal tip member; and

at least one aspiration passageway extending longitudinally through said distal tip member from the proximal surface thereof to the distal surface thereof, said aspiration passageway being in communication with the lumen of said outer tube such that matter located at the distal tip member may be aspirated, in the proximal direction, through said passageway and through the lumen of said outer tube.

2. The ultrasonic device of claim 1 wherein said catheter body comprises a pliable plastic cardiovascular catheter sized to be inserted into a mammalian blood vessel.

3. The ultrasonic device of claim 1 wherein said inner and outer tubes have central longitudinal axes, and said inner tube is positioned coaxially within the lumen of said outer tube.

4. The ultrasonic device of claim 3 wherein the lumenal diameter of the outer tube is at least 0.1 mm larger than the outer diameter of the inner tube, such that a luminal space of at least 0.1 mm exists between the lumenal surface of the outer tube and the outer surface of the inner tube.

5. The ultrasonic device of claim 1. further comprising:

at least one outlet passageway extending longitudinally through said distal tip member from the proximal surface thereof to the distal surface thereof;

wherein the lumen of the inner tube is in communication with said at least one outlet passageway such that fluid may be infused through said lumen, through said outlet passageway, and out the distal end of said catheter device.

6. The ultrasonic device of claim 1 wherein said ultrasound transmission member is formed of material which exhibits super elastic properties in the range of temperatures encountered by said ultrasound transmission member during operation of said device.

7. The ultrasonic device of claim 6 wherein the material of which said ultrasound transmission member is formed comprises nickel-titanium alloy.

8. The device of claim 7 wherein said nickel titanium alloy constitutes 50.8 anatomic percent nickel.

9. The ultrasonic device of claim 1 further comprising:

a guidewire passageway extending longitudinally through said distal tip member from the proximal end thereof to the distal end thereof, said guidewire passageway being in communication with a lumen of said catheter body such that a guidewire may be passed through the lumen of said catheter body and through said distal tip member.

10. The ultrasonic device of claim 9 further comprising:

a guidewire tube having a proximal end and a distal end, said guidewire tube being disposed in a lumen of said catheter body, the distal end of said guidewire tube being in communication with said guidewire passageway formed in said distal tip member, and the proximal end of said guidewire tube being in communication with a proximal guidewire outlet aperture formed in said device at a location proximal to the distal end of said catheter body.

11. The ultrasonic device of claim 10 wherein said proximal guidewire outlet aperture comprises an aperture formed in said pliable catheter body at a location 10-30 cm from the distal end of said catheter body.

12. The ultrasonic device of claim 10 wherein said proximal outlet guidewire aperture is located adjacent the proximal end of said catheter body.

13. The ultrasonic device of claim 1 further comprising:

a proximal connector assembly mounted on the proximal end of said catheter body, said proximal connector assembly incorporating a sonic connector apparatus whereby an external ultrasound source may be connected to the proximal end of said ultrasound transmission member.

14. The ultrasonic device of claim 13 wherein said proximal connector assembly further comprises:

a suction outlet port located on said proximal connector assembly in communication with the lumen of said catheter body which is in communication with said aspiration passageway, to facilitate aspiration of matter in the proximal direction, through said aspiration passageway, through said lumen, and out of said suction port.

15. The ultrasonic device of claim 1 further comprising:

at least one outlet passageway separated from the aspiration passageway, the outlet passageway extending longitudinally through said distal tip member, from the proximal surface thereof to the distal surface thereof, said at least one outlet passageway being in communication with a lumen of said catheter body such that fluid may be infused through said lumen, through said outlet passageway, and out of the distal end of said catheter device.

16. The device of claim 15 further comprising:

a proximal connector assembly mounted on the proximal end of said catheter body, said proximal connector assembly incorporating a sonic connector apparatus whereby an external ultrasound source may be connected to the proximal end of said ultrasound transmission member and a fluid inlet port located on said proximal connector assembly in communication with the lumen of the catheter body which is in communication with said outlet passageway to facilitate infusion of fluid, in the distal direction, through said fluid inlet port, through said lumen, through said outlet passageway, and out of the distal end of said device.

17. The device of claim 1 wherein the distal end of said inner tube terminates a spaced-distance short of the distal end of said outer tube, and wherein said distal tip member comprises:

a generally cylindrical member having a generally cylindrical outer surface of a diameter substantially the same as the lumenal diameter of said outer tube;

an annular depression formed about the periphery of the proximal surface of said tip member, said annular depression defining therewithin a central cylindrical proximal projection;

said distal tip member being inserted into the distal end of said catheter body such that outer cylindrical surface of said distal tip member is in abutment with the luminal surface of said outer tube, and such that the cylindrical proximal projection of said tip member is inserted into the distal end of the lumen of said inner tube.

18. The ultrasonic device of claim 1 wherein at least one outlet passageway is formed longitudinally through said distal tip member, from the proximal surface of the central proximal projection thereof, to the distal surface thereof such that fluid may be infused from the lumen of the inner tube, through the outlet passageway, and out of the distal end of the device.

19. The ultrasonic device of claim 18 wherein the at least one aspiration passageway extends longitudinally through said distal tip member from the annular shoulder formed in the proximal surface thereof to the distal surface thereof and in communication with the lumenal space between the lumenal surface of the outer tube and the outer surface of the inner tube such that matter may be aspirated from the distal surface of the distal tip member, through the aspiration passageway and into the lumenal space.

20. The ultrasonic device of claim 19 further comprising:

a plurality of aspiration passageways, each of which is in communication with the lumenal space between the lumenal surface of the outer tube and the outer surface of the inner tube; and

a plurality of infusion passageways, each of which is in communication with the lumen of the inner tube;

whereby aspiration and infusion may occur simultaneously.

21. The apparatus of claim 3 wherein said distal tip member is inserted into the distal end of a lumen of said catheter body, and secured to said catheter body by adhesive.

22. The apparatus of claim 3 wherein said distal tip member is inserted into the distal end of a lumen of said catheter body, and secured to said catheter body by heat fusing.

23. The ultrasonic device of claim 1 wherein the distal tip member comprises a concave indentation formed in the distal surface.

24. The ultrasonic device of claim 1 further comprising:

an infusion passageway formed through the distal tip member;

a plurality of lumina disposed in the catheter body such that separate lumina are in communication with the aspiration passageway and the infusion passageway;

whereby aspiration and infusion may be performed simultaneously.

25. The ultrasonic device of claim 24 further comprising:

a plurality of aspiration passageways each of which is in communication with a first lumen of the catheter body; and

a plurality of infusion passageways, each of which is in communication with a second lumen of the catheter body.

26. A method for removing obstructive matter from an anatomical passageway, said method comprising the steps of:

a) providing an ultrasonic catheter device which comprises;

an elongate pliable catheter body having a proximal end, a distal end, and at least one lumen extending longitudinally therethrough;

a distal tip member fixedly attached to the distal end of said catheter body for engaging the obstructive matter, said distal tip member having a distal surface;

an ultrasound transmission member extending longitudinally through said catheter body to transmit ultrasound from an ultrasound source located adjacent the proximal end of said catheter body, through said catheter body, to said distal tip member;

at least one aspiration passageway extending longitudinally through said distal tip member from the proximal surface thereof to the distal surface thereof, said aspiration passageway being in communication with a lumen of said catheter such that matter located at the distal tip member may be aspirated, in the proximal direction, through said passageway and through said lumen of said catheter;

b) inserting said catheter body into said anatomical passageway wherein the obstructive material is located;

c) advancing said catheter body to a point where said distal tip member is located adjacent the obstructive matter to be removed;

d) passing ultrasound through said ultrasound transmission member through said distal tip member, thereby causing said distal tip member to undergo ultrasonic vibratory movement;

e) advancing said catheter body such that the distal surface of said distal tip member comes into contact with said obstructive matter, and such that the ultrasonic vibratory movement of said distal tip member facilitates severance of a portion of said obstructive matter; and

f) causing a severed portion of said obstructive matter to be aspirated in the proximal direction, through said aspiration passageway, and through a lumen of said catheter body.

27. The methods of claim 26 where in the catheter provided in step a) further comprises at least one outlet passageway which extends longitudinally through said distal tip member, in communication with a lumen of said catheter body, and wherein said method further comprises:

g) infusing fluid through said lumen of said catheter body and out of said outlet passageways, in the area of said obstructive matter.

28. The method of claim 27 wherein steps f and g are conducted seperately.

29. A method for removing obstructive matter from a tortuous anatomical passageway, said method comprising the steps of:

a) providing an ultrasonic catheter device which comprises;

an elongate pliable catheter body having a proximal end, a distal end, and at least one lumen extending longitudinally therethrough;

a distal tip member fixedly attached to the distal end of said catheter body for engaging the obstructive matter, said distal tip member having a distal surface;

a solid, flexible ultrasound transmission member extending longitudinally through said catheter body to transmit ultrasound from an ultrasound source located externally to said catheter body, to said distal tip member;

at least one aspiration passageway extending longitudinally through said distal tip member from the proximal surface thereof to the distal surface thereof, said aspiration passageway being in communication with a lumen of said catheter such that matter located at the distal tip member may be aspirated, in the proximal direction, through said passageway and through said lumen of said catheter;

at least one outlet passageway which extends longitudinally through said distal tip member, in communication with a lumen of said catheter body;

b) inserting said catheter body into said tortuous anatomical passageway wherein the obstructive material is located;

c) advancing said catheter body through said tortuous anatomical passageway to a point where said distal tip member is located adjacent the obstructive matter to be removed;

d) passing ultrasound through said ultrasound transmission member through said distal tip member, thereby causing said distal tip member to undergo ultrasonic vibratory movement;

e) advancing said catheter body through said tortuous anatomical passageway such that the distal surface of said distal tip member comes into contact with said obstructive matter, and such that the ultrasonic vibratory movement of said distal tip member facilitates serverance of a portion of said obstructive matter;

f) causing a severed portion of said obstructive matter to be aspirated in the proximal direction, through said aspiration passageway, and through a lumen of said catheter body; and

g) infusing fluid through said lumen of said catheter body and out of said outlet passageways, in the area of said obstructive matter;

where in steps f and g are conducted concurrently.