Systems and methods for making and using image-guided intravascular and endocardial therapy systems

Abstract

A catheter assembly includes a catheter and a delivery element. The catheter has a distal end with a distal tip, a proximal end, and a longitudinal length. The catheter includes a body that defines a central lumen extending along the catheter to the distal end. The catheter also includes a forward-facing transducer array disposed at the distal tip of the catheter. The transducer array is configured and arranged for transforming applied electrical signals to acoustic signals and also for transforming received echo signals to electrical signals. At least one catheter conductor is electrically coupled to the transducer array and extends along the catheter. The delivery element is disposed in the lumen of the catheter. The delivery element includes a distal tip that is configured and arranged for contacting patient tissue. The distal tip of the delivery element is configured and arranged to extend beyond the distal tip of the catheter.

What is claimed as new and desired to be protected by Letters Patent of the United States is: 
     
         1 . A method for performing an intravascular or endocardial therapy procedure, the method comprising:
 inserting a catheter assembly into a catheter-insertion location within a blood vessel of a patient, the catheter assembly comprising a catheter defining a lumen and a delivery element having a distal tip disposed in the lumen, wherein the catheter comprises a forward-facing transducer array disposed a distal end portion of the catheter;   guiding the catheter through patient vasculature such that the distal tip of the delivery element is in proximity to a target therapy site;   generating at least one image of the target therapy site using the transducer array;   inserting a distal tip of the delivery element into patient tissue at the target therapy site; and   drawing a dose of a therapeutic agent from a therapeutic source through the delivery element to the target therapy site.   
     
     
         2 . The method of  claim 1 , wherein guiding the catheter through patient vasculature comprises guiding the catheter to a portion of a wall of the left ventricle of the heart of the patient. 
     
     
         3 . The method of  claim 1 , wherein guiding the catheter through patient vasculature comprises generating at least one image of patient vasculature between the catheter-insertion location and the target therapy site using the transducer array. 
     
     
         4 . The method of  claim 1 , wherein generating at least one image of the target therapy site using the transducer array comprises generating an intravascular or endocardial ultrasound image. 
     
     
         5 . The method of  claim 1 , wherein generating at least one image of the target therapy site using the transducer array comprises generating an image from a transducer array that comprises a plurality of capacitive micromachined ultrasonic transducer imaging elements. 
     
     
         6 . The method of  claim 1 , wherein generating at least one image of the target therapy site using the transducer array comprises generating an image from a transducer array that is electrically coupled to at least one integrated circuit disposed along the catheter. 
     
     
         7 . The method of  claim 1 , wherein generating at least one image of the target therapy site using the transducer array comprises generating an image from an annular transducer array. 
     
     
         8 . The method of  claim 7 , wherein inserting a distal tip of the delivery element into patient tissue at the target therapy site comprises extending the distal tip of the delivery element through the middle of the annular transducer array. 
     
     
         9 . The method of  claim 1 , wherein inserting a distal tip of the delivery element into patient tissue at the target therapy site comprises piercing patient tissue with the distal tip of the delivery element. 
     
     
         10 . The method of  claim 1 , further comprising detecting when the delivery element is contacting patient tissue using the at least one image generated of the target therapy site. 
     
     
         11 . The method of  claim 1 , further comprising providing information for improving selection of the location of the target therapy site using the at least one image generated of the target therapy site. 
     
     
         12 . The method of  claim 11 , wherein providing information for improving selection of the location of the target therapy site comprises providing information on the thickness of patient tissue at the target therapy site. 
     
     
         13 . The method of  claim 11 , wherein providing information for improving selection of the location of the target therapy site comprises detecting the presence of at least one of fibrosis or a region of infarct along patient tissue at the target therapy site. 
     
     
         14 . The method of  claim 1 , wherein drawing a dose of a therapeutic agent from a therapeutic source through the delivery element to the target therapy site comprises drawing the therapeutic agent through at least one lumen defined along the delivery element. 
     
     
         15 . The method of  claim 1 , wherein drawing a dose of a therapeutic agent from a therapeutic source through the delivery element to the target therapy site comprises drawing from the therapeutic source an angiotensin-converting-enzyme inhibitor. 
     
     
         16 . The method of  claim 1 , wherein drawing a dose of a therapeutic agent from a therapeutic source through the delivery element to the target therapy site comprises drawing from the therapeutic source an anti-inflammatory agent. 
     
     
         17 . The method of  claim 1 , wherein drawing a dose of a therapeutic agent from a therapeutic source through the delivery element to the target therapy site comprises drawing from the therapeutic source a non-steroidal anti-inflammatory drug. 
     
     
         18 . The method of  claim 1 , wherein drawing a dose of a therapeutic agent from a therapeutic source through the delivery element to the target therapy site comprises drawing from the therapeutic source an angiogenic agent. 
     
     
         19 . The method of  claim 1 , wherein drawing a dose of a therapeutic agent from a therapeutic source through the delivery element to the target therapy site comprises drawing from the therapeutic source an inotropic agent. 
     
     
         20 . The method of  claim 1 , wherein drawing a dose of a therapeutic agent from a therapeutic source through the delivery element to the target therapy site comprises drawing from the therapeutic source a sclerosing agent.