Apparatus and method of removing occlusions using an ultrasonic medical device operating in a transverse mode

Abstract

A method for removing an occlusion is provided comprising introducing a transverse mode ultrasonic probe into a blood vessel, positioning the probe in proximity to the occlusion, and transmitting ultrasonic energy to the probe, until the occlusion is removed. The probe has a small cross-sectional lumen and is articulable for navigating in a tortuous vessel path. The probe can be used with acoustic and/or aspirations sheaths to enhance destruction and removal of an occlusion. The probe can also be used with a balloon catheter. The probe, sheaths, and catheter can be provided in a sharps container which further provides a means of affixing and detaching the probe from an ultrasonic medical device.

We claim:  
     
         1 . An ultrasonic probe for removing an occlusion in a blood vessel comprising: 
 a first terminus at a proximal end of the ultrasonic probe;    a second terminus at a distal end of the ultrasonic probe terminating in a probe tip; and    a longitudinal axis between the first terminus and the second terminus;    wherein the ultrasonic probe vibrates in a transverse direction generating a plurality of nodes and a plurality of anti-nodes of cavitation energy along the longitudinal axis of the ultrasonic probe to produce an occlusion destroying effect along at least a portion of the longitudinal axis of the ultrasonic probe.    
     
     
         2 . The ultrasonic probe of  claim 1  wherein a diameter of the ultrasonic probe decreases at defined intervals from the first terminus to the second terminus.  
     
     
         3 . The ultrasonic probe of  claim 1  wherein a diameter of the ultrasonic probe is approximately uniform from the first terminus to the second terminus.  
     
     
         4 . The ultrasonic probe of  claim 1  wherein the ultrasonic probe has a flexibility to articulate the ultrasonic probe through the blood vessel.  
     
     
         5 . The ultrasonic probe of  claim 1  wherein a sheath surrounds at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         6 . The ultrasonic probe of  claim 1  wherein the occlusion is reduced to micron-sized particles.  
     
     
         7 . The ultrasonic probe of  claim 1  wherein the ultrasonic probe comprises one or more irrigation passages along at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         8 . The ultrasonic probe of  claim 1  wherein the ultrasonic probe comprises one or more aspiration channels along at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         9 . The ultrasonic probe of  claim 1  wherein a transverse vibration of the ultrasonic probe generates a retrograde flow of debris away from the probe tip.  
     
     
         10 . An ultrasonic medical device for destroying an occlusion in a blood vessel comprising: 
 an ultrasonic probe having a first terminus at a proximal end, a second terminus at a distal end and a longitudinal axis between the first terminus and the second terminus; and    a transducer coupled to the first terminus of the ultrasonic probe,    wherein the transducer transfers an ultrasonic energy to the ultrasonic probe creating a transverse vibration along at least a portion of the longitudinal axis of the ultrasonic probe.    
     
     
         11 . The ultrasonic medical device of  claim 10  further comprising a sheath surrounding at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         12 . The ultrasonic medical device of  claim 10  wherein the transverse vibration creates a plurality of nodes and a plurality of nodes along at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         13 . The ultrasonic medical device of  claim 12  wherein the plurality of nodes are regions of maximum energy emitted by the ultrasonic probe.  
     
     
         14 . The ultrasonic medical device of  claim 10  wherein the transverse vibration creates a cavitation in a medium surrounding the ultrasonic probe to destroy the occlusion.  
     
     
         15 . The ultrasonic medical device of  claim 10  wherein the occlusion is reduced to micron-sized particles.  
     
     
         16 . The ultrasonic medical device of  claim 10  wherein the ultrasonic probe comprises one or more irrigation passages along at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         17 . The ultrasonic medical device of  claim 10  wherein the ultrasonic probe comprises one or more aspiration channels along at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         18 . An ultrasonic medical device for removing an occlusion from a vessel comprising: 
 an ultrasonic probe having a first terminus at a proximal end, a second terminus at a distal end of the ultrasonic probe terminating in a probe tip and a longitudinal axis between the first terminus and the second terminus;    a transducer coupled to the first terminus of the ultrasonic probe; and    a balloon catheter comprising a balloon supported by the balloon catheter,    wherein the balloon transmits an ultrasonic energy from the ultrasonic probe to the occlusion to remove the occlusion.    
     
     
         19 . The ultrasonic medical device of  claim 18  further comprising a sheath surrounding at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         20 . The ultrasonic medical device of  claim 18  wherein the balloon is inflated to engage a wall of the vessel.  
     
     
         21 . The ultrasonic medical device of  claim 18  wherein the ultrasonic energy from the ultrasonic probe creates a transverse ultrasonic vibration along at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         22 . The ultrasonic medical device of  claim 18  wherein a transverse ultrasonic vibration of the ultrasonic probe creates a cavitation in a medium surrounding the ultrasonic probe to remove the occlusion.  
     
     
         23 . The ultrasonic medical device of  claim 18  wherein the occlusion is reduced to micron-sized particles.  
     
     
         24 . A kit for removing an occlusion comprising: 
 an ultrasonic probe having a first terminus at a proximal end of the ultrasonic probe, a second terminus at a distal end of the ultrasonic probe and a longitudinal axis between the first terminus and the second terminus;    a sheath sized to surround at least a portion of the longitudinal axis of the ultrasonic probe; and    instructions for assembling and tuning an ultrasonic medical device.    
     
     
         25 . The kit of  claim 24  further comprising packaging wherein the ultrasonic probe and the sheath are pre-sterilized and sealed against contaminants.  
     
     
         26 . The kit of  claim 24  further comprising a container for the ultrasonic probe.  
     
     
         27 . The kit of  claim 26  wherein the container complies with regulations governing the storage, handling and disposal of a sharp medical device.  
     
     
         28 . The kit of  claim 26  wherein the container comprises a single use locking mechanism.  
     
     
         29 . A method of removing an occlusion from a blood vessel comprising: 
 providing an ultrasonic probe having a first terminus at a proximal end of the ultrasonic probe, a second terminus at a distal end of the ultrasonic probe and a longitudinal axis between the first terminus and the second terminus;    inserting the ultrasonic probe into the blood vessel;    moving the ultrasonic probe to a site of the occlusion; and    activating an ultrasonic generator coupled to the ultrasonic probe,    wherein the occlusion is removed in areas adjacent to a plurality of energetic nodes produced along a portion of the longitudinal axis of the ultrasonic probe, the plurality of energetic nodes generated from a transverse vibration of the ultrasonic probe.    
     
     
         30 . The method of  claim 29  further comprising irrigating the site of the occlusion by at least one irrigation passage located along at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         31 . The method of  claim 29  further comprising aspirating the site of the occlusion by at least one aspiration channel located along at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         32 . The method of  claim 29  further comprising reducing the occlusion to micron-sized particles by the transverse vibration.  
     
     
         33 . The method of  claim 29  further comprising transmitting an ultrasonic energy from the ultrasonic generator by a transducer engaging the first terminus of the ultrasonic probe to transversely vibrate the ultrasonic probe.  
     
     
         34 . The method of  claim 29  further comprising providing an imaging device to view the ultrasonic probe.  
     
     
         35 . The method of  claim 29  further comprising providing a sheath surrounding at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         36 . The method of  claim 35  wherein the sheath comprises an at least one irrigation channel.  
     
     
         37 . The method of  claim 35  wherein the sheath comprises an at least one aspiration channel.  
     
     
         38 . The method of  claim 29  further comprising providing the ultrasonic probe having a flexibility allowing the ultrasonic probe to be articulated in the blood vessel.  
     
     
         39 . A method for destroying an occlusion in a blood vessel comprising: 
 providing an ultrasonic probe having a first terminus at a proximal end of the ultrasonic probe, a second terminus at a distal end of the ultrasonic probe and a longitudinal axis between the first terminus and the second terminus;    providing a balloon catheter having a balloon supported by the balloon catheter;    inserting the balloon catheter proximal to the occlusion;    inserting the ultrasonic probe through the balloon catheter and moving the ultrasonic probe proximal to the occlusion;    inflating the balloon of the balloon catheter to engage the balloon with a wall of the blood vessel;    activating an ultrasonic generator engaged to the ultrasonic probe to provide an ultrasonic energy to the ultrasonic probe creating a transverse ultrasonic vibration of the ultrasonic probe,    wherein the balloon transmits the ultrasonic energy from the ultrasonic probe to the occlusion to destroy the occlusion.    
     
     
         40 . The method of  claim 39  further comprising providing a sheath surrounding at least a portion of the longitudinal axis of the ultrasonic probe.  
     
     
         41 . The method of  claim 39  further comprising reducing the occlusion to micron-sized particles by the transverse ultrasonic vibration of the ultrasonic probe.  
     
     
         42 . The method of  claim 39  wherein the balloon of the balloon catheter is inflated to a pressure to maintain engagement between the balloon and the wall of the blood vessel.  
     
     
         43 . The method of  claim 39  further comprising providing an imaging device to view the ultrasonic probe.  
     
     
         44 . The method of  claim 39  wherein the transverse ultrasonic vibration creates a plurality of nodes and a plurality of anti-nodes along at least a portion of the longitudinal axis of the ultrasonic probe.