Use of focused ultrasound for vascular sealing

Abstract

An ultrasonic applicator unit ( 2 ) is used diagnostically to locate a puncture wound ( 316 ) in an artery and then therapeutically to seal the puncture wound with high intensity focused ultrasound (HIFU). A control unit ( 6 ) coupled to the applicator unit includes a processor ( 74 ) that automates the procedure, controlling various parameters of the diagnostic and therapeutic modes, including the intensity and duration of the ultrasonic energy emitted by the applicator unit. A protective, sterile acoustic shell ( 4 ), which is intended to be used with a single patient and then discarded, is slipped over the applicator unit to protect against direct contact between the applicator unit and the patient and to maintain a sterile field at the site of the puncture. The apparatus and method are particularly applicable to sealing a puncture made when inserting a catheter into an artery or other vessel. Several different procedures are described for locating the puncture wound, including imaging the vessel in which the puncture is disposed and use of a locator rod to determine the disposition of the puncture along the longitudinal axis of the artery.

1 . A system for delivering energy to a vascular treatment site, the system comprising:
 a first ultrasonic transducer configured to deliver ultrasound therapy to the vascular treatment site; and   a control unit configured to detect an alignment of the first ultrasonic transducer relative to the vascular treatment site, wherein the control unit is further configured to control the first ultrasonic transducer based at least in part on the detected alignment of the first ultrasonic transducer relative to the vascular treatment site.   
     
     
         2 . The system of  claim 1 , wherein the first ultrasonic transducer comprises a phased array ultrasonic transducer. 
     
     
         3 . The system of  claim 1 , further comprising a second ultrasonic transducer configured to send and receive a downstream pulsed Doppler line. 
     
     
         4 . The system of  claim 3 , wherein the second ultrasonic transducer is configured to send and receive an upstream pulsed Doppler line. 
     
     
         5 . The system of  claim 4 , wherein the second ultrasonic transducer is configured to send sequentially the downstream pulsed Doppler line and the upstream pulsed Doppler line. 
     
     
         6 . The system of  claim 5 , wherein the downstream pulsed Doppler line and the upstream pulsed Doppler line are disposed on a common plane. 
     
     
         7 . The system of  claim 6 , wherein the control unit is configured to receive the downstream pulsed Doppler line and the upstream pulsed Doppler line from the second ultrasonic transducer to detect the alignment of the first ultrasonic transducer relative to the second ultrasonic transducer. 
     
     
         8 . The system of  claim 7 , wherein the control unit is configured to activate the first ultrasonic transducer to deliver the ultrasound therapy to the vascular treatment site when the downstream pulsed Doppler line and the upstream pulsed Doppler line are substantially aligned with an artery. 
     
     
         9 . The system of  claim 1 , wherein the first ultrasonic transducer is configured to deliver an ultrasonic pulse to detect the presence of a nerve structure. 
     
     
         10 . The system of  claim 9 , wherein the intensity of the ultrasonic pulse is less than about 1,000 Watts per square centimeter. 
     
     
         11 . The system of  claim 1 , wherein the control unit comprises a processor configured to perform an alignment detection scheme. 
     
     
         12 . A system for delivering energy to a vascular treatment site, the system comprising:
 a first ultrasonic transducer configured to deliver ultrasound therapy to the vascular treatment site; and   a second ultrasonic transducer configured to image the vascular treatment site,   wherein the first ultrasonic transducer is configured to overscan the vascular treatment site when delivering the ultrasound therapy such that the delivery of the ultrasound therapy by the first ultrasonic transducer results in a region of therapy surrounding the vascular treatment site, and wherein the ultrasound therapy is based at least in part on the imagining provided by the second ultrasonic transducer.   
     
     
         13 . The system of  claim 12 , further comprising a control unit configured to send signals to the first ultrasound transducer, wherein the signals enable transcutaneous delivery of ultrasound therapy to the vascular treatment site. 
     
     
         14 . The system of  claim 13 , wherein the control unit comprises a processor configured to control at least one of the first ultrasonic transducer and the second ultrasonic transducer. 
     
     
         15 . The system of  claim 12 , wherein the first ultrasonic transducer has an aspheric shape. 
     
     
         16 . The system of  claim 12 , wherein the second ultrasonic transducer is configured to send and receive a downstream pulsed Doppler line. 
     
     
         17 . The system of  claim 16 , wherein the second ultrasonic transducer is configured to send and receive an upstream pulsed Doppler line. 
     
     
         18 . The system of  claim 17 , wherein the second ultrasonic transducer is configured to send sequentially the downstream pulsed Doppler line and the upstream pulsed Doppler line. 
     
     
         19 . The system of  claim 18 , wherein the downstream Doppler line and the upstream Doppler line are disposed on a common plane. 
     
     
         20 . The system of  claim 12 , wherein the ultrasound therapy comprises an ultrasonic pulse configured to detect the presence of a nerve structure. 
     
     
         21 . The system of  claim 20 , wherein the intensity of the ultrasonic pulse is less than about 1,000 Watts per square centimeter. 
     
     
         22 . A system for delivering energy to a vascular treatment site, the system comprising:
 a first ultrasonic transducer configured to deliver ultrasound therapy to the vascular treatment site;   a second ultrasonic transducer configured to image the vascular treatment site; and   a control unit configured to receive a first alignment input from the second ultrasonic transducer and to control the first ultrasonic transducer   
     
     
         23 . The system of  claim 22 , wherein the control unit is further configured to send signals to the first ultrasound transducer, wherein the signals enable transcutaneous delivery of ultrasound therapy to the vascular treatment site 
     
     
         24 . The system of  claim 22 , wherein the control unit is further configured to receive a second alignment input from an operator. 
     
     
         25 . The system of  claim 24 , wherein the control unit controls the first ultrasonic transducer based at least in part on at least one of the first alignment input and the second alignment input. 
     
     
         26 . The system of  claim 22 , wherein the second ultrasonic transducer is configured to send and receive a downstream pulsed Doppler line. 
     
     
         27 . The system of  claim 26 , wherein the second ultrasonic transducer is configured to send and receive an upstream pulsed Doppler line. 
     
     
         28 . The system of  claim 27 , wherein the second ultrasonic transducer is configured to send sequentially the downstream pulsed Doppler line and the upstream pulsed Doppler line. 
     
     
         29 . The system of  claim 28 , wherein the downstream Doppler line and the upstream Doppler line are disposed on a common plane. 
     
     
         30 . The system of  claim 22 , wherein the ultrasound therapy comprises an ultrasonic pulse configured to detect the presence of a nerve structure. 
     
     
         31 . The system of  claim 30 , wherein the intensity of the ultrasonic pulse is less than about 1,000 Watts per square centimeter. 
     
     
         32 . The system of  claim 30 , wherein the ultrasound therapy delivered by the first ultrasonic transducer is based at least in part on the detection of a nerve structure. 
     
     
         33 . The system of  claim 22 , wherein the control unit comprises a processor configured to control at least one of the first ultrasonic transducer and the second ultrasonic transducer.