Flexible elongate device having a vibratory impact tip and method of its use

• US 5,449,369 A
• Filed: 04/28/1994
• Issued: 09/12/1995
• Est. Priority Date: 12/01/1992
• Status: Expired due to Term

• Current Assignee: Avantec Vascular Corporation (Nipro Corporation)
• Original Assignee: Intelliwire Incorporated
• Inventors: Imran, Mir A.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): DAWSON, GLENN K
• Application Number:
  US08/235,127
• Time in Patent Office: 502 Days
• Field of Search: 128/656-658, 128/772, 128/898, 604/22, 604/95, 604/96, 604/104, 604/164, 604/170, 604/264, 604/280-282, 606/1, 606/127, 606/128, 606/159, 606/167, 606/170, 606/171, 606/169, 606/190-194
• US Class Current: 606/159
• 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 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61M 25/0113 Mechanical advancing means, e.g. catheter dispensers
• CPC Class Codes: A61M 25/09041 Mechanisms for insertion of guide wires

Abstract

A flexible elongate device including a flexible elongate tubular member having proximal and distal extremities. A flexible coil spring is provided having proximal and distal extremities. The proximal extremity of the coil spring is secured to the distal extremity of the flexible elongate tubular member. A rounded tip is secured to the distal extremity of the coil spring. A flexible elongate element having proximal and distal extremities is disposed within said coil spring and extends longitudinally of the coil spring. The distal extremity of the flexible elongate element is secured to the rounded tip. A vibrator is secured to the proximal extremity of the flexible elongate element for imparting vibratory motion to the flexible elongate element to cause vibratory impact motion of the rounded tip in a direction longitudinal of the axis of the flexible elongate element.

Claims

1. A flexible elongate device comprising a flexible elongate tubular member having proximal and distal extremities, a flexible coil spring having proximal and distal extremities, means securing the proximal extremity of the coil spring to the distal extremity of the flexible elongate tubular member, a rounded tip secured to the distal extremity of the coil spring, a flexible elongate element having proximal and distal extremities disposed within said coil spring and having an axis extending longitudinally of the coil spring, means securing the distal extremity of the flexible elongate element to the rounded tip and means secured to the proximal extremity of the flexible elongate element for imparting vibratory motion to the flexible elongate element to cause vibratory impact motion of the rounded tip in a direction longitudinal of the axis of the flexible elongate element.

2. A device as in claim 1 wherein said means secured to the proximal extremity of the flexible elongate element is in the form of an electrically actuated solenoid having a plunger, wherein said flexible elongate element is secured to said plunger and wherein said solenoid is provided with means for retaining said plunger in said solenoid, said flexible elongate element serving as a safety wire for retaining the rounded tip on the distal extremity of the coil spring.

3. A device as in claim 2 wherein said means secured to the proximal extremity of the flexible elongate element includes a power supply connected to the solenoid for supplying electrical energy to the solenoid and control means connected to the power supply for adjusting the amount of energy supplied to the solenoid to adjust the impact provided by the rounded tip.

4. A device as in claim 1 wherein said flexible elongate element is in the form of a shape-memory alloy element together with electrical means connected to the shape-memory alloy element for supplying current to the shape-memory alloy element to increase the stiffness of the shape-memory alloy element.

5. A device as in claim 2 together with a tube disposed within the spring and having a bore therein through which the flexible elongate element extends and serving to minimize the friction encountered by the flexible elongate element as it is reciprocated by the solenoid.

6. A device as in claim 1 together with a plurality of circumferentially disposed flexible elongate elements having a negative coefficient of expansion disposed within the interior of the coil spring and having distal extremities secured to the distal extremity of the coil spring and conductive means for supplying energy in the form of electrical currents to the plurality of flexible elongate elements having a negative coefficient of expansion and control means for adjusting the electrical currents supplied through the plurality of flexible elongate elements having a negative coefficient of expansion to cause steering of the distal extremity of the coil spring.

7. A device as in claim 1 wherein the flexible elongate tubular member is in the form of a catheter together with an inflatable balloon mounted on the distal extremity of the catheter and means carried by the flexible elongate member for inflating and deflating the balloon.

8. A method for crossing a stenosis of a totally or almost totally occluded vessel of a patient by the use of a flexible elongate device having proximal and distal extremities and having a coil spring with proximal and distal extremities with the proximal extremity of the coil spring secured to the distal extremity of the flexible elongate device and a rounded tip secured to the distal extremity of the coil spring and electrically actuatable means carried by the distal extremity of the flexible elongate device and connected to the rounded tip for imparting vibratory motion to the rounded tip comprising advancing the rounded tip of the device into the vessel into contact with the stenosis, supplying electrical energy from the proximal extremity to the electrically actuable means at the distal extremity of the flexible elongate device to generate substantially undamped vibratory motion solely at the distal extremity of the flexible elongate device so as to impart vibratory motion to the rounded tip to facilitate advancement of the rounded tip through the stenosis to form a passage through the stenosis without danger of penetrating the wall of the vessel.

9. The method as in claim 8 wherein said device is a guide wire together with a balloon dilatation catheter having a balloon, further comprising the steps of inserting the balloon dilatation catheter over the guide wire to advance the balloon of the balloon dilatation catheter into and through the stenosis and inflating and deflating the balloon to enlarge the passage through the stenosis and thereafter withdrawing the balloon dilatation catheter and the guide wire.

10. A method as in claim 8 wherein said device is in the form of a balloon dilatation catheter having a balloon further comprising the steps of advancing the balloon dilatation catheter into the passage in the stenosis after the tip has crossed the stenosis so that the balloon is in registration with the stenosis and inflating and deflating the balloon to increase the size of the passage through the stenosis and thereafter withdrawing the balloon dilatation catheter.

11. A method as in claim 8 wherein the vibratory motion is imparted in a direction which is generally parallel to the vessel wall.

12. A flexible elongate device for crossing a stenosis of a totally or almost totally occluded vessel of a patient comprising a flexible elongate tubular member having proximal and distal extremities, a flexible coil spring having proximal and distal extremities and having an axis, means securing the proximal extremity of the coil spring to the distal extremity of the flexible elongate tubular member, a rounded tip secured to the distal extremity of the coil spring, electrically actuatable means carried by the distal extremity of the flexible elongate tubular member and connected to the rounded tip and means for supplying electrical energy from the proximal extremity of the flexible elongate tubular member to the electrically actuable means at the distal extremity of the flexible elongate tubular member to generate substantially undamped vibratory motion solely at the distal extremity of the flexible elongate tubular member which is imparted to the rounded tip in a direction longitudinal of the axis of the coil spring.