Fully integrated, disposable tissue visualization device

Abstract

The present invention relates to a fully integrated sterilizable one time use disposable tissue visualization device and methods for using such devices. Preferred embodiments of the invention facilitate the visualization of an internal tissue site while causing a minimum of damage to the surrounding tissue. Further preferred embodiments may allow for the delivery of fluids and other treatment to an internal tissue site.

What is claimed is: 
     
         1 . A sterilized, integrated, one time use disposable tissue visualization device, comprising:
 a handle comprising a visualization sensor;   a monitor configured to display an image;   an elongated body, extending along a longitudinal axis between a proximal end affixed to the handle, and a distal end comprising a laterally deflected, sharpened tip;   an elongate optical element extending through the elongated body, the optical element having a proximal end in optical communication with the visualization sensor and a distal end;   a control on the handle, for axially moving the elongated body between a proximal position in which the sharpened tip is proximal to the distal end of the optical element, and a distal position in which the sharpened tip is distal to the distal end of the optical element;   wherein the distal end of the elongated body is configured to pierce through tissue along the longitudinal axis; and   wherein the distal end of the elongate optical element comprises a viewing axis deflected laterally from the longitudinal axis.   
     
     
         2 . The tissue visualization device of  claim 1 , wherein the lateral displacement of the sharpened tip is 50% of an outside diameter of the elongated body. 
     
     
         3 . The tissue visualization device of  claim 1 , wherein the viewing axis is at a 15 degree angle from the longitudinal axis. 
     
     
         4 . The tissue visualization device of  claim 1 , wherein the elongate optical element further comprises a field of view, the field of view comprising a frontward view along the longitudinal axis. 
     
     
         5 . The tissue visualization device of  claim 1 , wherein the visualization sensor communicates with the monitor wirelessly. 
     
     
         6 . The tissue visualization device of  claim 1 , wherein the handle comprises a clamshell shape. 
     
     
         7 . The tissue visualization device of  claim 1 , wherein the distal end is laterally deflected via an axially movable control wire. 
     
     
         8 . The tissue visualization device of  claim 1 , wherein the elongated body comprises a lumen configured to deliver an anti-inflammatory agent to the internal tissue site. 
     
     
         9 . The tissue visualization device of  claim 1 , further comprising a rotational sensor, the rotational sensor configured to determine the rotational orientation of the visualization device. 
     
     
         10 . The tissue visualization device of  claim 9 , wherein the rotational sensor communicates with the monitor to rotate the image such that a patient reference direction will always appear on the top of the screen. 
     
     
         11 . The tissue visualization device of  claim 1 , wherein the elongated body comprises an outer tubular body, wherein the outer tubular body is constructed from a heat-sensitive material. 
     
     
         12 . A method of manufacturing a tissue visualization device, comprising
 slicing a tubular reflective material at a desired angle to expose an angled surface;   milling the angled surface until the angled surface is configured to reflect an image;   inserting the tubular reflective material into a tubular body, the tubular body comprising a window; and   positioning the tubular reflective material such that the angled surface reflects light passing through the window.