Needleless injection device components, systems, and methods

Abstract

Described are needleless injection systems and methods that involve features including one or more of a tissue tensioner and a fitting that includes or attaches to a shaft, exemplary embodiments including: an elastic sleeve sized to fit under tension about the distal end of a flexible scope, such as an endoscope; a non-metal, polymeric tube-like device being optionally attached to the elastic sleeve for delivering a therapeutic fluid to a treatment site within a patient wherein the elastic sleeve may include an integral balloon (tissue tensioner) feature that can be used to position the injection orifice of the tube-like device proximate a treatment area.

1 - 14 . (canceled) 
     
     
         15 . A needleless injection device capable of injecting fluid into tissue, the device comprising
 a working shaft comprising a working shaft proximal end and a working shaft distal end,   a lumen assembly comprising a proximal end, a distal end, a tubular inner shaft extending from the proximal end to the distal end, and a tubular outer shaft extending from the proximal end to the distal end, an injection lumen being located at an interior of the tubular inner shaft, and an inflation lumen being located at an annular space between the tubular inner shaft and the tubular outer shaft, and   a tissue tensioner engaged with the working shaft, the tissue tensioner comprising an inflatable balloon in fluid communication with the proximal end of the inflation lumen.   
     
     
         16 . A needless injection device according to  claim 15  comprising the working shaft and a tissue tensioner assembly, the tissue tensioner assembly comprising the tissue tensioner, the lumen assembly, and a removable fitting that can be removably attached to the working shaft. 
     
     
         17 . A needless injection device according to  claim 15  comprising the working shaft, a tissue tensioner assembly, and a lumen assembly, the device further comprising a post that can removably connect the tissue tensioner assembly to the working shaft. 
     
     
         18 . A needleless injection device according to  claim 15  wherein the lumen assembly is located along a length of the working shaft at an exterior of the working shaft. 
     
     
         19 . A needleless injection device according to  claim 16  wherein the removable fitting comprises an elongate receptor comprising one or more of: an elastic band, a snap-fit engagement, an elastic channel, a press-fit engagement, a threaded engagement, a key-fit engagement, and combinations of these fittings. 
     
     
         20 . A needleless injection device according to  claim 15  wherein the working shaft comprises a steerable distal end. 
     
     
         21 . A needleless injection device according to  claim 15  wherein the inner shaft is an injection shaft comprising a sidewall and an injection orifice comprising a bore through the sidewall, the injection orifice located along a length of the injection shaft distal end a distance in the range from about 1 to about 40 millimeters on a proximal side of a distal end tip of the injection lumen. 
     
     
         22 . A needleless injection device according to  claim 21  wherein
 the injection shaft comprises
 an injection orifice at the injection shaft distal end, and 
 an injection lumen in fluid communication with the injection orifice and extending between an injection shaft proximal end and an injection shaft distal end, wherein the injection lumen is capable of withstanding a pressure of at least 200 pounds per square inch. 
 
 
     
     
         23 . A needleless injector device according to  claim 15  wherein the inflatable balloon is capable of expanding asymmetrically relative to a longitudinal axis of the working shaft measured at a distal end of the working shaft. 
     
     
         24 . A needleless injector device according to  claim 15  wherein the injection shaft comprises an injection orifice and the inflatable balloon is capable of expanding in a direction opposite a direction of fluid ejected from the injection orifice. 
     
     
         25 - 35 . (canceled) 
     
     
         36 . A method of injecting tissue of a patient, the method comprising
 providing a needleless injection device according to  claim 15 ,   placing a distal end of the needleless injection device in a body lumen of a patient with the tissue tensioner in a non-expanded state,   expanding the tissue tensioner within the body lumen, and   ejecting a fluid stream from the injection lumen such that the injection stream penetrates tissue.   
     
     
         37 . A method according to  claim 36  comprising ejecting a fluid stream from the injection lumen such that the injection stream penetrates tissue of a body lumen. 
     
     
         38 . A method according to  claim 37  wherein the body lumen is a prostatic urethra and the injection stream penetrates prostate tissue. 
     
     
         39 . A method according to  claim 36  comprising inflating the balloon, wherein the balloon expands asymmetrically relative to a longitudinal axis of the working shaft measured at a distal end of the working shaft. 
     
     
         40 . A method according to  claim 36  comprising inflating the balloon and ejecting fluid from an injection orifice, wherein the balloon expands in a direction opposite a direction of the ejected fluid stream. 
     
     
         41 - 42 . (canceled)