Catheter apparatus, system and method for intravascular two-dimensional ultrasonography

• US 4,794,931 A
• Filed: 02/28/1986
• Issued: 01/03/1989
• Est. Priority Date: 02/28/1986
• Status: Expired due to Term

• Current Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiovascular Systems Incorporated (Boston Scientific Corporation)
• Inventors: Yock, Paul G.
• Primary Examiner(s): Jaworski, Francis J.
• Application Number:
  US06/834,893
• Time in Patent Office: 1,040 Days
• Field of Search: 128/660, 128/661, 128/663, 128/4-6, 128/303.1, 128/305, 128/303.15, 128/303.17
• US Class Current: 600/439
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 2017/00924 for ultrasonic waves
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22045 fixed to the catheter; guiding tip
• CPC Class Codes: A61B 2017/22052 eccentric
• CPC Class Codes: A61B 2017/22074 the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
• CPC Class Codes: A61B 2017/22078 for rotating the instrument within a channel, e.g. an optical fibre
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 2090/3784 both receiver and transmitter being in the instrument or receiver being also transmitter
• 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 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe

Abstract

Ultrasonic apparatus, system and method for high resolution intravascular imaging to assist indovascular lesions and to monitor the results of interventional therapy. An ultrasonic transducer is carried by the distal end of a catheter adapted for insertion into a vessel, and either the transducer or another element is rotated and/or translated relative to the catheter to image different portions of the vessel.

Claims

1. A catheter apparatus for obtaining an image of a patient'"'"'s vessel having a wall comprising:

a flexible tubular element adapted for insertion into the body lumen, the tubular element having distal and proximal extremities;

a housing having distal and proximal ends and a longitudinal axis, the proximal end of the housing being secured to the distal extremity of the tubular element, the housing having a portion thereof that is substantially transparent to ultrasonic energy;

ultrasonic means for generating ultrasonic signals and directing the ultrasonic signals in a direction that is substantially perpendicular to the longitudinal axis of the housing and for receiving reflections of the signals generated, the ultrasonic means including a rotatable member that is movable longitudinally and rotatably relative to the housing during scanning to permit scanning a discrete length of the vessel wall;

drive means extending through the tubular element and connected to the rotatable member for causing both longitudinal and rotational movement of the rotatable member with respect to the housing about the longitudinal axis of the housing whereby the ultrasonic signals generated by the ultrasonic means are directed onto the vessel wall and the ultrasonic signals reflected by the vessel wall are received by the ultrasonic means;

and a cutting element secured to said rotatable member for longitudinal movement relative to the housing, said cutting element having a circular cutting edge lying in a plane which is substantially perpendicular to the longitudinal axis of the housing.

2. Apparatus as in claim 1 together with means carried by the housing for collecting material which is removed by the cutting edge.

3. Apparatus as in claim 1 wherein the cutting element includes a recess formed therein for receiving material removed by the cutting edge.

4. Apparatus as in claim 1 together with flexible guide wire means associated with the housing for facilitating steering of the catheter apparatus.

5. Apparatus as in claim 1 wherein the circular cutting edge faces in a direction towards the distal extremity of the housing.

6. Apparatus as in claim 1 wherein the circular cutting edge faces in a direction toward the proximal extremity of the housing.

7. In a catheter apparatus for obtaining an image of a vessel in the vascular system of a patient, a flexible tubular element adapted to be inserted into the vessel and having a longitudinal axis, a flexible rotatable element disposed within the tubular element for rotational movement about the longitudinal axis relative to the tubular element, an ultrasonic transducer carried by the flexible tubular element for generating and receiving ultrasonic signals, electrical circuit means carried by the tubular element and connected to the transducer for supplying signals to and receiving signals from the transducer, and drive means for imparting longitudinal and rotational movement to the rotatable element and directing means mounted on the rotatable element for causing the ultrasonic signals to be directed outwardly and received inwardly relative to the axis of rotation of the rotatable element during rotational and longitudinal movement of the rotatable element so that the ultrasonic signals are rotated and moved longitudinally to provide an image of the portion of the vessel being veiwed.

8. A catheter apparatus as in claim 7 together with means for displaying an image from the signals received from the transducer during rotating of the rotatable element.

9. A catheter apparatus as in claim 7 wherein said reducing means is a cutting device.

10. A catheter apparatus as in claim 7 wherein said ultrasonic transducer includes a crystal together with a backing material carried by the crystal for inhibiting propagation of sonic waves from the crystal in the direction of the backing material.

11. A catheter apparatus as in claim 7 wherein said circuit means is carried by the tubular element.

12. In a catheter apparatus for obtaining an image of a vessel in the vascular system of a patient, a flexible tubular element adapted to be inserted into the vessel, a flexible rotatable element disposed within the tubular element for rotational movement relative to the tubular element, an ultrasonic transducer carried by the flexible tubular element for generating ultrasonic signals, electrical circuit means carried by the tubular element and connected to the transducer for supplying signals to and receiving signals from the transducer, and drive means for imparting rotational movement to the rotatable element and directing means mounted on the rotatable element for causing the ultrasonic signals to be directed outwardly and received inwardly relative to the axis of rotation of the rotatable element during rotation of the rotatable element to provide information with respect to an image of the portion of the vessel being viewed and reducing means secured to the rotatable element for reducing a stenosis within the vessel, the ultrasonic transducer being disposed in relatively close proximity to the reducing means.

13. A catheter apparatus as in claim 12 together with inflatable balloon carried by the reducing means and adapted to be inflated to stabilize the reducing means, and wherein said tubular element includes means for inflating and deflating the balloon.

14. In a catheter system for obtaining an image of a vessel in a vascular system, an elongate flexible element adapted to enter the vessel, a flexible rotatable elongate element disposed in the tubular element, an ultrasonic transducer carried by the flexible rotatable element and being rotatable therewith for scanning the vessel, motor means for rotating the flexible rotatable element, the flexible rotatable element and the transducer carried thereby being movable longitudinally with respect to the tubular element, transmitter means coupled to the ultrasonic transducer and producing electrical signals and supplying the same to the ultrasonic transducer to cause ultrasonic waves to be propagated therefrom and to be shifted longitudinally as the rotatable element is moved longitudinally and rotated as the rotatable element is rotated, receiver means coupled to the ultrasonic transducer, the ultrasonic transducer being capable of receiving reflected ultrasonic waves and supplying electrical signals to the receiver means, timing control means for causing operation of the transmitter means, the receiver means and the motor means and means connected to the receiver means for creating a visual display of the vessel being scanned by the ultrasonic transducer.

15. A system as in claim 14 together with a work performing device carried by the flexible rotatable element.

16. In a method for obtaining an image of a vessel in the vascular system of a patient using a vascularly interventional catheter having a cutting means for reducing a stenosis within the vessel, and a housing that carries an ultrasonic transducer, introducing the catheter into the vessel, scanning the vessel ultrasonically both rotationally and longitudinally while the cutting means is being operated and creating an image from the scan.

17. A catheter apparatus for obtaining an image of a vascular vessel having a wall comprising:

an elongate flexible tubular element having distal and proximal extremities;

a housing having distal and proximal ends and a longitudinal axis, the proximal end of the housing being secured to the distal extremity of the tubular element, the housing having a portion thereof that is substantially transparent to ultrasonic energy;

ultrasonic means for generating ultrasonic signals and directing the ultrasonic signals in a direction that is substantially perpendicular to the longitudinal axis of the housing and toward the wall of the vessel and for receiving reflections from the walls of the vessel of the ultrasonic signals generated, the ultrasonic means including a rotatable member that is movable longitudinally and rotatably relative to the housing during scanning to permit scanning a discrete length of the vessel; and

motorized drive means extending through the tubular element and connected to the rotatable member and being movable longitudinally and for causing rotational movement of the rotatable member with respect to the housing about the longitudinal axis of the housing so that the ultrasonic signals generated are rotated and can be moved longitudinally with respect to the wall of the vessel.

18. Apparatus as recited in claim 17 wherein said rotatable member carries the ultrasonic transducer.

19. Apparatus as in claim 17 wherein said rotatable member is a reflector inclined at an angle of approximately 45°

and wherein the transducer is disposed in a direction which is perpendicular to the longitudinal axis of the housing and is mounted in a fixed position in the housing, whereby ultrasonic energy from the transducer is directed onto the reflector and reflected ultrasonic energy is received by the reflector and directed onto the transducer.

20. Apparatus as in claim 17 wherein the housing is provided with a cutout on one side, together with an inflatable balloon carried by the housing and disposed on the exterior of the housing on the side of the housing opposite the cutout and means carried by the tubular element for inflating and deflating the inflatable balloon.

21. A catheter apparatus for obtaining an image of a vascular vessel having a stenosis therein comprising:

a flexible tubular element adapted for insertion into the vascular vessel, the tubular element having distal and proximal extremities;

a housing having distal and proximal ends and a longitudinal axis, the proximal end of the housing being secured to the distal extremity of the tubular element, the housing having a portion thereof that is substantially transparent to ultrasonic energy;

ultrasonic means for generating ultrasonic signals and directing the ultrasonic signals in a direction that is substantially perpendicular to the longitudinal axis of the housing and for receiving reflections of the signals generated, the ultrasonic means including a rotatable member that is movable longitudinally and rotatably relative to the housing during scanning to permit scanning a discrete length of the vessel;

drive means extending through the tubular element and connected to the rotatable member permitting longitudinal movement and for causing rotational movement of the rotatable member with respect to the housing about the longitudinal axis of the housing so that the ultrasonic signals generated by the ultrasonic means are directed onto the vessel and the ultrasonic signals reflected by the vessel are received by the ultrasonic means; and

means coupled to said drive means for removing materials from the stenosis including a cutter having an annular cutting edge.

22. A catheter apparatus for obtaining an image of a vascular vessel having a wall comprising:

a flexible tubular member adapted for insertion into the vascular vessel and having a longitudinal axis,

ultrasonic means for generating ultrasonic signals and detecting reflections of the ultrasonic signals, the ultrasonic means including a rotatable element disposed within the tubular member and adapted for rotational and longitudinal movement relative to the longitudinal axis of the tubular member, the rotatable element directing the ultrasonic signals outwardly from the catheter apparatus towards the wall of the vessel,

drive means connected to the rotatable element and extending through the tubular member for rotating the rotational element relative to the longitudinal axis of the tubular member, and permitting longitudinal movement of the rotatable element along the longitudinal axis and

reducing means carried by the tubular member for reducing a stenosis within the vessel, the reducing means and the ultrasonic means being adapted so that imaging of the vessel can occur simultaneously while reducing the stenosis.

23. In a catheter apparatus for obtaining an image of a vessel in a body and reducing a stenosis within the vessel the vessel having a vessel wall,

a flexible tubular element adapted for insertion into the vessel and having a longitudinal axis,

a cutter rotatable relative to the tubular element with respect to the longitudinal axis of the tubular element for reducing the stenosis,

ultrasonic means for generating ultrasonic signals and detecting reflections of the ultrasonic signals, the ultrasonic means including a rotatable element adapted for rotational movement with the cutter relative to the longitudinal axis of the tubular member for directing the ultrasonic signals outwardly from the catheter apparatus towards the vessel wall, and

drive means connected to the cutter and rotatable element and extending through the tubular member for rotating the cutter and rotatable element relative to the tubular member.

24. A catheter apparatus as in claim 23, further comprising a motor means for rotating the drive means.

25. In a catheter apparatus for obtaining an image of the wall of a vessel in the vascular system of a patient, an elongate flexible tubular element having distal and proximal extremities, said distal extremity having a longitudinal axis, flexible guide wire means adapted to extend beyond the distal extremity of the tubular element longitudinally of the longitudinal axis of the distal extremity of the tubular element, the flexible guide wire means and the tubular element being of a size such that they can be readily introduced into the vessel, the tubular element and the flexible guide wire means having a flexibility so that the distal extremity of the tubular element can be advanced in the vessel and follow the path of the vessel, the distal extremity of the tubular element having a portion thereof which is substantially transparent to ultrasonic energy, means including an ultrasonic transducer disposed within the distal extremity of the tubular element for generating ultrasonic energy and for directing the same through said portion toward the wall of the vessel, electrical circuit means connected to the ultrasonic transducer and carried by the tubular element and motor-driven elongate flexible drive means extending through the flexible tubular element and connected to said means for generating and directing ultrasonic energy.

26. A cathether apparatus as in claim 25 wherein said distal extremity of the tubular element is in the form of a housing.

27. A catheter apparatus as in claim 26 wherein the flexible guide wire means is secured to the housing.

28. A catheter apparatus as in claim 25 wherein the means disposed within the tubular element for generating ultrasonic energy and for directing the same also includes a rotatable mirror connected to the flexible drive means.