Medical instrument for accessing a breast duct for performing a medical procedure

Abstract

A medical instrument including a ductal access device comprising a low profile, ergonomic manifold hub usable to introduce fluids into a breast duct and collect ductal fluid samples including ductal epithelial cells and clumps of ductal epithelial cells from within a breast duct. The ductal access device also comprises an elongated access catheter having a distal end, one lumen and dimensions which permit introduction of the distal end through a ductal orifice so that a distal end of the catheter may be positioned distal to the ductal sphincter of a human breast. The medical instrument may also include at least one spacing member for adjustably positioning the manifold hub a desired distance above the surface of the nipple. The spacing member may control the insertion depth of the catheter into the duct. The medical instrument may also include at least one member for anchoring the device to the breast.

1 . A device for being introduced and positioned within a breast duct for introducing or removing material within the breast duct, said apparatus comprising: 
 a manifold hub comprising a plurality of port openings in fluid communication with an interior of said manifold hub;    a catheter extending from the manifold hub, said catheter being sized and configured for positioning within a breast duct and;    an anchoring member secured to said manifold hub for securing the device to the body of a patient;    wherein said catheter includes a longitudinal axis; and said manifold hub includes a height that extends substantially parallel to said longitudinal axis of said catheter and a length that extends substantially perpendicular to said longitudinal axis of said catheter, wherein said length of said manifold hub is greater than the height of said manifold hub.    
     
     
         2 : The device of  claim 1  wherein said plurality of ports of said manifold hub comprises at least four ports in fluid communication with an interior of said manifold hub.  
     
     
         3 : The device of  claim 1  wherein said catheter extends from a first end of said manifold hub, and further comprising a sealing fitting positioned at a second end of said manifold hub opposite said catheter, said sealing fitting including an aperture that may be repeatedly opened and closed.  
     
     
         4 : The device of  claim 3  wherein said sealing fitting includes a Touhy-Borst fitting for sealing about a member extending through said manifold hub at said second end of said manifold hub.  
     
     
         5 : The device of  claim 4  wherein said Touhy-Borst fitting comprises a silicone plug comprising said aperture and a threaded cap such that when said cap is turned in a first direction, the silicone plug is altered and a size of said opening within said silicone plug is reduced, thereby forming a seal about said member extending through said manifold hub.  
     
     
         6 : The device of  claim 1  wherein said anchoring member has a lower surface for contacting the body of the patient, and said lower surface includes a biocompatible adhesive.  
     
     
         7 : The device of  claim 1  further comprising a source of negative pressure in communication with said manifold hub for directing a ductal fluid sample from within said manifold hub to a ductal fluid collection receptacle.  
     
     
         8 : The device of  claim 7  wherein said source of negative pressure comprises a powered vacuum source in fluid communication with said manifold hub.  
     
     
         9 : The device of  claim 7  wherein said source of negative pressure comprises a mechanically controlled negative pressure source in fluid communication with said manifold hub.  
     
     
         10 : The device of  claim 1  further comprising a fluid container for holding a fluid being delivered to the breast duct, a fluid infusion member for delivering fluid from said fluid container to said manifold hub, a ductal fluid collection receptacle and a ductal fluid collection member extending between said manifold hub and said collection receptacle for delivering ductal fluid samples from said manifold hub to said collection receptacle.  
     
     
         11 : The device of  claim 10  wherein said fluid container includes a fluid bag for housing a biocompatible fluid, said fluid bag being positionable vertically above said manifold hub for delivering the biocompatible fluid to said manifold hub.  
     
     
         12 : The device of  claim 10  wherein said fluid infusion member includes a syringe.  
     
     
         13 : The device of  claim 10  wherein said ductal fluid collection receptacle includes a syringe.  
     
     
         14 : The device of  claim 10  wherein said ductal fluid collection receptacle includes a fluid collection bag for being vertically spaced below said manifold hub to receive a ductal fluid sample from within said manifold hub.  
     
     
         15 : The device of  claim 10  wherein said fluid infusion member and/or said ductal fluid collection member includes a one-way check valve.  
     
     
         16 : The device of  claim 1  wherein said catheter includes a microcatheter having a lubricious coating that allows said catheter to be easily introduced into the breast duct openings.  
     
     
         17 : The device of  claim 16  wherein said lubricious coating may include a lubricant, a cleaning agent, anesthetic and/or a dilating agent.  
     
     
         18 : The device of  claim 16  wherein a proximal end of said microcatheter includes an atraumatic tip.  
     
     
         19 : The device of  claim 1  wherein said manifold hub is formed of a transparent material.  
     
     
         20 : The device of  claim 19  wherein said transparent material includes an ABS plastic.  
     
     
         21 : The device of  claim 1  wherein said spacer comprises at least two telescoping members extending between the manifold hub and a portion of the catheter.  
     
     
         22 : The device of  claim 1  wherein said spacer includes a member that is moveable relative to the manifold hub such that a portion of the manifold hub is received within said moveable member.  
     
     
         23 : The device of  claim 1  wherein said manifold hub includes vertical sidewalls with recesses for receiving fingers of a practitioner or attendant for the easy manipulation of said manifold hub relative to the breast.