Steerable endoluminal punch

Abstract

This invention is a transvascularly placed punch, further including internal steerability and the ability to articulate in a direction at right angles to its longitudinal axis at or near its distal end. The punch is generally fabricated from stainless steel and includes an outer tube, an intermediate tube, a central stylet, hub structures, and a distal articulating region. The punch can be advanced through a body lumen in its straight configuration and then be selectively articulated or curved to permit negotiation of tortuous curvature or to permit optimal approach or access to a puncture site. The punch is able to create holes in the atrial septum of the heart or other structures and is easier to use than punches that are pre-curved near their distal tip since it is easier to advance through accessory catheters.

1 . An apparatus adapted for punching a hole in a body lumen or hollow organ of a mammal comprising: 
 an outer axially elongate hollow tube having a proximal end and a distal end;    an inner axially elongate hollow tube having a proximal end and a distal end;    a central lumen within said outer tube and extending substantially the length of said tube, wherein the inner tube can concentrically reside and rotate about its longitudinal axis;    a central lumen within said inner tube and extending substantially the length of said tube;    a first hub affixed to the proximal end of the outer axially elongate tube;    a second hub affixed to the proximal end of the inner axially elongate tube;    lock to selectively fix the rotational position of the first hub relative to the second hub;    a distal end of the either the inner tube or the outer tube configured to be sharp, wherein the sharp distal end is capable of punching a hole in a structure within the body lumen or hollow organ; and    an obturator slidably disposed within the central lumen of the inner tube, wherein the obturator can be advanced forward out the distal end of the tube or it can be removed from the tube by withdrawal through the proximal end of the tube.    
   
   
       2 . The apparatus of  claim 1  wherein said second hub comprises a valve at its proximal end.  
   
   
       3 . The apparatus of  claim 1  wherein said inner tube and said outer tube form an assembly, further wherein the inner and outer tubes are each pre-bent to form a curve proximate their distal end, wherein alignment of the curves of the inner and outer tube causes the assembly to comprise a bend and wherein when the inner and outer tube bends are directed opposite each other, the punch is substantially straight and uncurved.  
   
   
       4 . The apparatus of  claim 1  comprising pull wires and a flexible region, wherein asymmetrical tension on the pull wires at the proximal end of the first hub causes the pull wires, which are affixed at a point distal to the flexible region to bend the inner and the outer tubes in the flexible region.  
   
   
       5 . The apparatus of  claim 1  wherein the first hub and the second hub comprise pointer devices to confirm alignment of the first hub relative to the second hub.  
   
   
       6 . The apparatus of  claim 1  comprising at least one control rod and a flexible region, wherein axial tension or compression on the control rod at the proximal end of the first hub causes the control rod, which is affixed at a point distal to the flexible region to bend the inner and the outer tubes in the flexible region.  
   
   
       7 . The apparatus of  claim 1  wherein axial advancement of the inner tube relative to the outer tube exposes a sharp distal end on the inner tube, wherein said sharp distal end is capable of punching a hole in tissue.  
   
   
       8 . A method of punching a hole in a body lumen or hollow organ wall comprising the steps of: 
 Inserting a guidewire into a patient's body lumen and routing the guidewire to a location near a target site, wherein the target site is a organ or body lumen wall;    Advancing a guiding catheter over the guidewire to the target site;    Removing the guidewire;    Inserting an axially elongate punch into the guiding catheter and routing the punch to the target site, wherein the punch is substantially straight and uncurved;    Deflecting a region near the distal end of the punch so that the punch is oriented toward and against the target site; and    Punching a hole in the body lumen or hollow organ wall.    
   
   
       9 . The method of  claim 8  wherein the deflecting step comprises rotating a pre-curved intermediate tube relative to a pre-curved outer tube such that to maximize curvature, the curves of the intermediate tube and the outer tube are aligned with each other.  
   
   
       10 . The method of  claim 8  wherein the deflecting step comprises retracting or advancing a control rod, wherein the control rod extends substantially from the proximal end of the axially elongate punch to the region near the distal end of the punch that is deflected.  
   
   
       11 . The method of  claim 8  wherein the deflection step comprises electrically activating a shape memory actuator near the distal end of the punch.  
   
   
       12 . The method of  claim 8  wherein the deflection step comprises generating tension on one or more control wires, wherein the control wires extend substantially from the proximal end of the punch to the region near the distal end of the punch that is deflected.  
   
   
       14 . The method of  claim 8  further comprising the step of inserting an adjustable spacer between a hub of the punch and a hub of the guiding catheter, wherein the spacer prevents the distal tip of the punch to extend beyond the distal tip of the guiding catheter prior to the punching step.  
   
   
       15 . The method of  claim 8  further comprising the step of locking an adjustable spacer to a hub of the punch and a hub of the guiding catheter.  
   
   
       16 . The method of  claim 8  further comprising the step of advancing the punch through the hole in the body lumen or cavity.  
   
   
       17 . The method of  claim 8  further comprising the step of advancing the guide catheter and an obturator, having a central lumen, through the hole in the body lumen or cavity over the punch.  
   
   
       18 . The method of  claim 8  further comprising the step of removing the punch from the body lumen or cavity leaving a guide catheter in place.  
   
   
       19 . An apparatus adapted for punching a hole in a body lumen or hollow organ wall comprising: 
 An axially elongate tube comprising a distal end, a proximal end and a central lumen;    A means for punching tissue disposed at or near the distal end of the axially elongate tube;    A means for protecting the sharp distal end of the axially elongate tube while said axially elongate tube is being advanced to the treatment site;    A means for deflecting a region near the distal end of the axially elongate tube from a straight to a substantially curved configuration; and    A means to actuate the punch from the proximal end of the axially elongate tube.    
   
   
       20 . The apparatus of  claim 19  wherein said means for protecting the sharp distal end of the axially elongate tube comprises an accessory catheter through which the punch is inserted.