Intravascular ultrasonic catheter probe for treating intravascular blockage

Claim 1

An ultrasonic apparatus for the treatment of a patient having blood vessels obstructed by deposits of atherosclerotic plaque or blood clots, comprising: an ultrasonic energy source; an elongated, solid, flexible probe having first and second ends and coupled at the first end to the ultrasonic energy source and having a tip at the second end, the probe length selected so as to provide both longitudinal and transverse motion of the probe tip, the probe tip having a bulbous shape such that the tip of the probe is rounded and has a diameter greater than that of the remainder of the probe; and a hollow catheter for internally carrying a portion of the probe, the catheter having first and second ends; and the probe is adapted to slide within the catheter and to be extendable from the second end of the catheter into a mass of atherosclerotic plaque or blood clots.

Claim 9

An apparatus for use with an ultrasonic energy source and capable of being advanced in a blood vessel to the site of a blockage due to atherosclerotic plaque or blood clot for the treatment of the blockage, comprising: a flexible, elongated metal wire probe having one end adapted to be coupled to the ultrasonic energy source and having a bulbous, rounded tip at the other end, and the length of the probe being selected so that the probe length is an acoustical length of a whole number multiple of a one-half wavelength of the frequency of the ultrasonic energy source in the material of which the probe is constructed, with the bulbous tip of the probe located at an antinode of the probe length; a hollow catheter comprised of a flexible material having an inside diameter sufficient to internally carry the bulbous rounded tip of the probe, adapted to be inserted into the blood vessel at one end, and having an inflatable cuff at the inserted end that may be inflated to axially center the catheter and probe in the blood vessel; and means, coupled to the catheter, for introducing fluid into the blood vessel through the catheter.

Claim 10

An apparatus for use with an ultrasonic energy source and capable of being advanced in a blood vessel to the site of a blockage due to atherosclerotic plaque or blood clot for the treatment of the blockage, comprising: a flexible, elongated metal wire probe having one end adapted to be coupled to the ultrasonic energy source and having a bulbous, rounded tip at the other end, and the length of the probe being selected so that the probe length is an acoustical length of a whole number multiple of a one-half wavelength of the frequency of the ultrasonic energy source in the material of which the probe is constructed, with the bulbous tip of the probe located at an antinode of the probe length; a hollow catheter comprised of a flexible material having an inside diameter sufficient to internally carry the bulbous rounded tip of the probe, adapted to be inserted into the blood vessel at one end, and having an inflatable cuff at the inserted end that may be inflated to axially center the catheter and probe in the blood vessel; and means, coupled to the catheter, for introducing fluid into the blood vessel through the catheter.

Claim 11

A method of treating a patient suffering from partial or total blood vessel blockage due to the deposition of fibrous or calcified plaque or a blood clot on the blood vessel interior wall, employing an ultrasonic energy source; an elongated, hollow catheter; and an elongated, solid, flexible probe carried internally within the catheter, the probe having a bulbous, rounded tip, and having a length that results in both longitudinal and transverse motion of the probe tip; the method comprising the steps of: (a) attaching a first end of the catheter and probe to means for generating ultrasonic energy such that a second end of the probe is coextensive with a second end of the catheter; (b) making an incision in the outer skin of the patient down to a blood vessel; (c) introducing the catheter carrying the probe into the blood vessel and advancing the catheter and probe to the site of blockage by viewing a real-time x-ray image of the catheter and probe in the blood vessel; (d) extending the probe from the end of the catheter and thereby making contact with the fibrous or calcified plaque or blood clot at the site of blockage; and (e) transmitting ultrasonic energy along the probe so as to vibrate the probe tip at ultrasonic frequencies in the longitudinal and transverse directions, thereby breaking up and pulverizing the blockage.

Claim 12

A method of treating a patient suffering from partial or total blood vessel blockage due to the deposition of fibrous or calcified plaque or a blood clot on the blood vessel interior wall, employing an ultrasonic energy source; an elongated, hollow catheter; and an elongated, solid, flexible probe carried internally within the catheter, the probe having a bulbous, rounded tip, and having a length that results in both longitudinal and transverse motion of the probe tip; the method comprising the steps of: (a) attaching a first end of the catheter and probe to means for generating ultrasonic energy such that a second end of the probe is coextensive with a second end of the catheter; (b) making an incision in the outer skin of the patient down to a blood vessel; (c) introducing the catheter carrying the probe into the blood vessel and advancing the catheter and probe to the site of blockage by viewing a real-time x-ray image of the catheter and probe in the blood vessel; (d) extending the probe from the end of the catheter and thereby making contact with the fibrous or calcified plaque or blood clot at the site of blockage; and (e) transmitting ultrasonic energy along the probe so as to vibrate the probe tip at ultrasonic frequencies in the longitudinal and transverse directions, thereby breaking up and pulverizing the blockage.

Claim 15

The method of any one of claims 8 to 10 further comprising the step of: supplying a physiologic fluid through the catheter to the site of arterial blockage to control the temperature of the probe tip while the ultrasonic energy is being applied.

Claim 16

The method of any one of claims 8 to 11 further com­prising the step of: removing plaque debris from the area of the treatment site by creating a suction through the catheter.

Claim 17

The method of any one of claims 8 to 12 wherein the catheter has a plurality of internal passageways extending along its length, the method further comprising the step of: removing plaque debris from the area of the treatment site by creating a suction through one of the internal passageways.

Claim 18

The method of any one of claims 8 to 13 wherein the catheter has an annular, inflatable cuff located around the outer circumference of the first end of the catheter; and the step (d) of the method further includes inflating the annular cuff, thereby blocking off the treatment site and centering the catheter in the blood vessel.

Claim 19

A method of treating a patient suffering from partial or total blockage of a blood vessel due to the deposition of fibrous or calcified plaque or a blood clot on the blood vessel interior wall, employing an ultrasonic apparatus comprising an ultrasonic energy source; an elongated, solid, flexible probe coupled at a first end to the ultrasonic energy source and having a tip at a second end; and a hollow catheter for internally carrying a portion of the probe; such that the catheter is adapted to be coupled at a first end to means for introducing fluid into the catheter and inserted at a second end of the catheter into the blood vessel to be treated, the probe is adapted to slide within the catheter and to be extendable from the second end of the catheter into a mass of atherosclerotic plaque or blood clot, the probe tip has a bulbous shape such that the tip of the probe is rounded and has a diameter greater than that of the remainder of the probe, and the probe is selected to have a length that results in both longitudinal and transverse motion at the bulbous tip; the method comprising the steps of: (a) inserting the probe within the catheter and attaching the first end of the probe to the ultrasonic energy source such that the second end of the probe is coextensive with the second end of the catheter; (b) making an incision in the outer skin of the patient down to a blood vessel and inserting a self-sealing sheath into the blood vessel; (c) introducing the catheter carrying the probe through the self-sealing sheath and into the blood vessel, and advancing the catheter and probe to the site of blockage by viewing a real-time x-ray image of the catheter and probe in the blood vessel; (d) extending the probe from the end of the catheter and thereby making contact with the fibrous or calcified plaque or blood clot at the site of arterial blockage; and (e) transmitting ultrasonic energy along the probe so as to vibrate the probe tip at ultrasonic frequencies in the longitudinal and transverse directions, thereby breaking up and pulverizing the fibrous or calcified plaque or blood clot.

Claim 20

A method of treating a patient suffering from partial or total blockage of a blood vessel due to the deposition of fibrous or calcified plaque or a blood clot on the blood vessel interior wall, employing an ultrasonic apparatus comprising an ultrasonic energy source; an elongated, solid, flexible probe coupled at a first end to the ultrasonic energy source and having a tip at a second end; and a hollow catheter for internally carrying a portion of the probe; such that the catheter is adapted to be coupled at a first end to means for introducing fluid into the catheter and inserted at a second end of the catheter into the blood vessel to be treated, the probe is adapted to slide within the catheter and to be extendable from the second end of the catheter into a mass of atherosclerotic plaque or blood clot, the probe tip has a bulbous shape such that the tip of the probe is rounded and has a diameter greater than that of the remainder of the probe, and the probe is selected to have a length that results in both longitudinal and transverse motion at the bulbous tip; the method comprising the steps of: (a) inserting the probe within the catheter and attaching the first end of the probe to the ultrasonic energy source such that the second end of the probe is coextensive with the second end of the catheter; (b) making an incision in the outer skin of the patient down to a blood vessel and inserting a self-sealing sheath into the blood vessel; (c) introducing the catheter carrying the probe through the self-sealing sheath and into the blood vessel, and advancing the catheter and probe to the site of blockage by viewing a real-time x-ray image of the catheter and probe in the blood vessel; (d) extending the probe from the end of the catheter and thereby making contact with the fibrous or calcified plaque or blood clot at the site of arterial blockage; and (e) transmitting ultrasonic energy along the probe so as to vibrate the probe tip at ultrasonic frequencies in the longitudinal and transverse directions, thereby breaking up and pulverizing the fibrous or calcified plaque or blood clot.

Claim 24

The method of any one of claims 15 to 18 wherein the catheter has an annular balloon around its outer circumference at its second end and includes means for inflating the annular balloon; and the step (c) includes inflating the annular balloon so as to block off the treatment site and center the catheter in the blood vessel.