Medical device sheath apparatus and method of making and using same

Abstract

A medical device sheath apparatus and a method for using the apparatus is described. The sheath may include a self sealing fitting suitable for receiving a medical device, a first sheath for receiving the medical device as it passes through the fitting, and a second sheath surrounding the first sheath. A dilator, coupled to at least the second sheath, may also be provided. The apparatus allows therapeutic or diagnostic energy in such forms as electromagnetic radiation or acoustic to be applied to a treatment area. A method for making the apparatus is also described.

1 . A medical device sheath apparatus comprising: 
 a fitting being suitable for receiving said medical device in a self sealing manner;    a first sheath for receiving said medical device as it passes through said fitting;    a second sheath surrounding said first sheath;    a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through; and,    a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus.    
     
     
         2 . The apparatus of  claim 1 , wherein said medical device comprises an endoscope comprising a channel suitable for receiving an optical fiber suitable for irradiating biologic material through said dilator.  
     
     
         3 . The apparatus of  claim 1 , wherein said dilator is substantially non-distensible.  
     
     
         4 . The apparatus of  claim 1 , wherein said fitting comprises: 
 a seal housing; and,    a seal secured by said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device.    
     
     
         5 . The apparatus of  claim 4 , wherein said seal comprises at least one elastomeric material.  
     
     
         6 . The apparatus of  claim 4 , further comprising at least one retainer securing said seal to said housing.  
     
     
         7 . The apparatus of  claim 6 , wherein said seal, housing and retainer are integral.  
     
     
         8 . The apparatus of  claim 1 , further comprising a tube having an end positioned with respect to said window to enable introduction of a material substantially adjacent to said window through said fitting.  
     
     
         9 . The apparatus of  claim 1 , further comprising a tube having an end positioned with respect to said window to enable evacuation of material from an area substantially adjacent to said window through said fitting.  
     
     
         10 . The apparatus of  claim 1 , wherein said window is substantially transparent.  
     
     
         11 . The apparatus of  claim 10 , wherein said window comprises at least one anti-reflective coating.  
     
     
         12 . The apparatus of  claim 1 , wherein said first and second sheaths are adapted such that said medical device provides sufficient rigidity to insert said apparatus into a bodily cavity.  
     
     
         13 . The apparatus of  claim 1 , wherein said first sheath and fitting are coupled so as to permit a substantially distal portion of said medical device to be displaceable within said treatment area.  
     
     
         14 . The apparatus of  claim 1 , further comprising means for inflating said dilator wherein said means for inflating further comprises means for inflating said first sheath.  
     
     
         15 . The apparatus of  claim 1 , further comprising at least one marking on said first sheath, second sheath or dilator being suitable for determining a position of a substantially distal portion of said medical device using said medical device.  
     
     
         16 . The apparatus of  claim 15 , wherein said at least one marking is directly viewable.  
     
     
         17 . The apparatus of  claim 1 , wherein said first sheath and fitting are configured to define a substantially closed space upon insertion of said medical device.  
     
     
         18 . The apparatus of  claim 17 , wherein said dilator and first sheath define a second substantially closed space.  
     
     
         19 . A method for irradiating at least a portion of a bodily cavity comprising: 
 providing a sheath apparatus comprising: 
 a fitting being suitable for receiving said medical device in a self sealing manner;  
 a first sheath for receiving said medical device as it passes through said fitting;  
 a second sheath surrounding said first sheath;  
 a dilator defining a treatment area, coupled to at least said second sheath, and being suitable for dilating a bodily cavity and passing therapeutic or diagnostic energy there though; and,  
 a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus; and,  
   inserting at least a portion of said medical device into said apparatus;    positioning said medical device containing apparatus in said bodily cavity using direct viewing through said window and said medical device; and,    irradiating said portion of said bodily cavity through said apparatus using said medical device.    
     
     
         20 . The method of  claim 19 , further comprising partially withdrawing said medical device with respect to said apparatus prior to said irradiating, and advancing an irradiating device through said medical device to facilitate said irradiating, wherein said apparatus positioning remains substantially unchanged during said partial withdrawing of said device and advancing of said irradiating device.  
     
     
         21 . The method of  claim 20 , further comprising withdrawing said irradiating device through said medical device after to said irradiating, and advancing said medical device with respect to said apparatus after said irradiating.  
     
     
         22 . The method of  claim 21 , further comprising dilating said portion of said bodily cavity prior to said irradiating using said device containing apparatus.  
     
     
         23 . The method of  claim 22 , further comprising un-dilating said bodily cavity after said irradiating using said apparatus.  
     
     
         24 . The method of  claim 23 , further comprising removing said device containing apparatus after said irradiating.  
     
     
         25 . The method of  claim 19 , wherein said positioning and irradiating occur in a single insertion into said bodily cavity.  
     
     
         26 . The method of  claim 19 , wherein said medical device includes an irradiating device, further comprising partially withdrawing said medical device with regard to said apparatus, wherein said apparatus and irradiating device positioning with respect to said bodily cavity remains substantially unchanged during said partial withdrawing of said medical device.  
     
     
         27 . A method for making a medical device sheath apparatus comprising: 
 coupling a first sheath to a fitting being suitable for receiving said medical device in a self sealing manner;    coupling a second sheath to said fitting so as to surround said first sheath;    coupling a dilator defining a treatment area and being suitable for dilating a bodily cavity and passing therapeutic electromagnetic radiation there through to said second sheath; and,    coupling said first sheath to a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus.    
     
     
         28 . The method of  claim 27 , further comprising passing at least one air, water or suction line through said fitting.  
     
     
         29 . The method of  claim 28 , further comprising banding said at least one air, water or suction line to said inner sheath.  
     
     
         30 . The method of  claim 28 , further comprising securing said at least one of said at least one air, water or suction line substantially adjacent to said window.  
     
     
         31 . The method of  claim 27 , further comprising coupling said second sheath to said window.  
     
     
         32 . A medical device sheath apparatus comprising: 
 a fitting being suitable for receiving said medical device;    a seal being suitable for receiving said medical device through said fitting;    a sheath for receiving said medical device through said fitting and seal;    a dilator defining a treatment area, coupled to said sheath, and being suitable for dilating a bodily cavity and passing energy therethrough; and,    a window operatively positioned with respect to said sheath so as to enable viewing of an area substantially adjacent to said sheath upon insertion of said medical device into said apparatus.    
     
     
         33 . The apparatus of  claim 32 , wherein said medical device comprises an endoscope comprising a channel or attachment suitable for receiving an instrument suitable for passing a form of energy through said dilator.  
     
     
         34 . The apparatus of  claim 33 , wherein said endoscope comprises at least one of an irradiating fiber and ultrasound transducer.  
     
     
         35 . The apparatus of  claim 32 , wherein at least one of said dilator and sheath is substantially non-distensible.  
     
     
         36 . The apparatus of  claim 32 , wherein at least one of said dilator and sheath is substantially distensible.  
     
     
         37 . The apparatus of  claim 32 , wherein said fitting comprises: 
 a seal housing; and,    a seal secured in said housing and comprising a bore being suitable for receiving said medical device and sized to provide an air seal against an outside diameter of said medical device.    
     
     
         38 . The apparatus of  claim 37 , further comprising at least one retainer securing said seal to said housing.  
     
     
         39 . The apparatus of  claim 38 , wherein said seal, housing and retainer are integral.  
     
     
         40 . The apparatus of  claim 37 , wherein said seal comprises at least one elastomeric material.  
     
     
         41 . The apparatus of  claim 32 , further comprising a tube having an end positioned with respect to said window to enable introduction of a material substantially adjacent to said window through said fitting.  
     
     
         42 . The apparatus of  claim 32 , further comprising a tube having an end positioned with respect to said window to enable evacuation of material from an area substantially adjacent to said window through said fitting.  
     
     
         43 . The apparatus of  claim 32 , wherein said window is substantially transparent.  
     
     
         44 . The apparatus of  claim 43 , wherein said window comprises at least one anti-reflective coating.  
     
     
         45 . The apparatus of  claim 32 , wherein said sheath is sufficiently flexible such that said medical device provides sufficient rigidity to insert said apparatus into a bodily cavity.  
     
     
         46 . The apparatus of  claim 32 , wherein said sheath and fitting are coupled so as to permit a substantially distal portion of said medical device to be displaceable within said treatment area.  
     
     
         47 . The apparatus of  claim 32 , further comprising at least one marking on said sheath, medical device or dilator being suitable for determining a position of a substantially distal portion of said medical device.  
     
     
         48 . The apparatus of  claim 47 , wherein said at least one marking is directly viewable using said medical device.  
     
     
         49 . The apparatus of  claim 32 , wherein said sheath and fitting are configured to define a substantially closed space upon insertion of said medical device.  
     
     
         50 . The apparatus of  claim 47 , further comprising a second sheath secured to said fitting such that said dilator and second sheath define a second substantially closed space.  
     
     
         51 . The apparatus of  claim 37 , wherein said housing defines an internal bore corresponding to said bore of said seal, and said housing bore comprises a plurality of internal steps.  
     
     
         52 . The apparatus of  claim 51 , wherein said housing further comprises a first bonding location for said first sheath and a second bonding location for said second sheath.  
     
     
         53 . A method for making a medical device sheath apparatus comprising: 
 coupling a first sheath to a fitting being suitable for receiving said medical device in a self sealing manner;    coupling a second sheath to said fitting so as to surround said first sheath;    coupling a dilator defining a treatment area and being suitable for dilating a bodily cavity and passing therapeutic or diagnostic energy there through to said second sheath; and,    coupling said first sheath to a window operatively positioned with respect to said first sheath so as to enable viewing of an area substantially adjacent said second sheath upon insertion of said medical device into said apparatus.