Apparatus and method for the treatment of thrombotic occlusions in vessels

• US 5,688,234 A
• Filed: 01/26/1996
• Issued: 11/18/1997
• Est. Priority Date: 01/26/1996
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Vascular Enterprises Limited (Abbott Laboratories)
• Original Assignee: Cardiometrics, Inc. (Koninklijke Philips N.V.)
• Inventors: Frisbie, Jeffrey S.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): TAO, ELLEN
• Application Number:
  US08/592,001
• Time in Patent Office: 662 Days
• Field of Search: 604/35-36, 604/41-43, 604/52-53, 604/96, 604/105-108, 604/22, 604/49, 606/127-28, 606/194, 606/159, 606/180
• US Class Current: 604/22
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/2215 having an open distal end

Abstract

Apparatus for the treatment of a thrombotic occlusion in a vessel of a patient comprising a flexible elongate tubular sheath having proximal and distal extremities. A relatively large lumen defined by a thin flexible wall extends from the proximal extremity to the distal extremity of the tubular sheath so that the distal extremity is open. An occlusion disruption device is slidably and rotatably disposed in the lumen in the tubular sheath and includes a flexible elongate torsionally rigid shaft having a length greater than the length of the tubular sheath and having proximal and distal extremities. The shaft has a guide wire lumen extending from the proximal extremity to the distal extremity. Disruption elements are secured to the distal extremity of the shaft which when rotated disrupt the thrombotic occlusion by causing it to break into pieces. Suction is applied to the lumen in the tubular sheath to aspirate pieces into the large lumen of the tubular sheath to remove them from the vessel of the patient.

Claims

1. Apparatus for use with a guide wire for the treatment of a thrombotic occlusion in a patient having a vessel with thrombus and plaque therein and capable of being advanced to said thrombotic occlusion comprising a flexible elongate tubular sheath having proximal and distal extremities and having a relatively large lumen extending from the proximal extremity to the distal extremity so that the distal extremity is open and the lumen is defined by a thin flexible wall, a thrombotic occlusion disruption device slidably and rotatably disposed in the lumen in the tubular sheath, said thrombotic occlusion disruption device including a flexible elongate torsionally rigid shaft having a length greater than the length of the tubular sheath and having proximal and distal extremities, the shaft having a guide wire lumen extending from the proximal extremity to the distal extremity of the shaft and sized to receive the guide wire, said shaft being sufficiently flexible so that it can be advanced over and follow said guide wire to the thrombotic occlusion in a vessel, a plurality of distally extending prong shaped disruption elements having proximal and distal extremities means securing the proximal extremities of the disruption elements to the distal extremity of the shaft, the distal extremities of the disruption elements being movable between retracted positions when disclosed in the lumen of the tubular sheath and expanded positions when disposed outside the lumen of the tubular sheath, means coupled to the proximal extremity of the shaft for rotating the shaft and the disruption elements carried thereby, said disruption elements being rigid enough so that during rotation the thrombotic occlusion in the vessel of the patient is disrupted by causing it to break into smaller pieces, said disruption elements also being flexible enough so that during rotation the plaque in the vessel is left intact and means coupled to the proximal extremity of the tubular sheath for aspirating into the large lumen of the tubular sheath pieces of the thrombotic occlusion and removing them from the vessel of the patient.

2. Apparatus as in claim 1 further comprising a balloon mounted on the distal extremity of the tubular sheath, said balloon being proximal of the plurality of when the plurality of are in the expanded position and means carried by the tubular sheath for inflating and deflating the balloon.

4. Apparatus as in claim 1 wherein said disruption elements are formed of a radiopaque material.

5. Apparatus as in claim 1 wherein said disruption elements have inwardly turned distal extremities.

6. Apparatus as in claim 1 wherein said disruption elements are spaced apart circumferentially.

7. Apparatus as in claim 1 together with additional lumens formed in the tubular sheath.

3. Apparatus for use with a guide wire for the treatment of a thrombotic occlusion in a patient having a vessel with thrombus and plaque therein and capable of being advanced to said thrombotic occlusion comprising a flexible elongate tubular sheath having proximal and distal extremities and having a relatively large lumen extending from the proximal extremity to the distal extremity so that the distal extremity is open and the lumen is defined by a thin flexible wall, a thrombotic occlusion disruption device slidably and rotatably disposed in the lumen in the tubular sheath, said thrombotic occlusion disruption device including a flexible elongate torsionally rigid shaft having a length greater than the length of the tubular sheath and having proximal and distal extremities. the shaft having a guide wire lumen extending from the proximal extremity to the distal extremity of the shaft and sized to receive the guide wire, said shaft being sufficiently flexible so that it can be advanced over and follow said guide wire to the thrombotic occlusion in a vessel, a plurality of disruption elements having proximal and distal extremities, means securing the proximal extremities of the disruption elements to the distal extremity of the shaft, the distal extremities of the disruption elements being movable between retracted positions when disposed in the lumen of the tubular. sheath and expanded positions when disposed outside the lumen of the tubular sheath, means coupled to the proximal extremity of the shaft for rotating the shaft and the disruption elements carried thereby, said disruption elements being rigid enough so that during rotation the thrombotic occlusion in the vessel of the patient is disrupted by causing it to break into smaller pieces, said disruption elements also being flexible enough so during rotation the plaque in the vessel is left intact, said shaft also having an outer surface, said outer surface being provided with a helix for carrying the smaller pieces of the thrombotic occlusion from the distal extremity to the proximal extremity of the shaft and means coupled to the proximal extremity of the tubular sheath for aspirating into the large lumen of the tubular sheath pieces of the thrombotic occlusion and removing them from the vessel of the patient.

8. A method for treatment of thrombotic occlusions in a patient having a vessel with thrombus and plaque therein by the use of a flexible tubular sheath having proximal and distal extremities with a lumen extending from the proximal extremity to the distal extremity, a thrombotic occlusion disruption device slidably and rotatably disposed within the lumen of the sheath, said disruption device having a shaft with proximal and distal extremities and a guide wire lumen extending from the proximal extremity to the distal extremity of the shaft, distally extending prong shaped disruption elements having poroximal and distal extremities, means securing the proximal extremities of the disruption elements to the distal extremity of the shaft, the distal extremities of the disruption elements being movable between retracted positions when disposed in the lumen of the tubular sheath and expanded positions when disposed outside the lumen of the tubular sheath, the method comprising providing a guide wire having a distal extremity, the method comprising inserting the guide wire into the vessel of a patient through said shaft until the distal extremity of the guide wire is in the proximity of the thrombotic occlusion in the vessel of the patient, advancing the occlusion disruption device out of the tubular sheath so that the disruption elements are exposed, causing rotation of the disruption elements while advancing the same through the thrombotic occlusion to cause disruption of the thrombotic occlusion into pieces, applying suction from the tubular sheath to aspirate the pieces dislodged from the thrombotic occlusion and withdrawing the occlusion disruption device from the vessel while leaving the plaque intact inside the vessel.

9. A method as in claim 8 wherein said shaft is rotated at a speed from 10 rpm to 500 rpm.

10. Apparatus for use with a guide wire for the treatment of a thrombotic occlusion in a patient having a vessel with thrombus and plaque therein and capable of being advanced to said thrombotic occlusion comprising a flexible elongate tubular sheath having proximal and distal extremities and having a relatively large lumen extending from the proximal extremity to the distal extremity so that the distal extremity is open and the lumen is defined by a thin flexible wall, a thrombotic occlusion disruption device slidably and rotatably disposed in the lumen in the tubular sheath, said thrombotic occlusion disruption device including a flexible elongate torsionally rigid shaft having a length greater than the length of the tubular sheath and having proximal and distal extremities, the shaft having a guide wire lumen extending from the proximal extremity to the distal extremity of the shaft and sized to receive the guide wire, said shaft being sufficiently flexible so that it can be advanced over and follow said guide wire to the thrombotic occlusion in a vessel, a plurality of distally extending prong shaped disruption elements secured to the distal extremity of the shaft, means coupled to the proximal extremity of the shaft for rotating the shaft and the disruption elements carried thereby, said disruption elements being rigid enough so that during rotation the thrombotic occlusion in the vessel is disrupted by causing it to break into smaller pieces, said disruption elements also being flexible enough so that during rotation the plaque in the vessel is left intact and means coupled to the proximal extremity of the tubular sheath for aspirating into the large lumen of the tubular sheath pieces of the thrombotic occlusion and removing them from the vessel of the patient.