Pulmonary occlusal stent delivery catheter, loading system and methods of use

Abstract

Methods, systems and devices are provided for performing lung volume reduction in patients suffering from chronic obstructive pulmonary disease or other conditions where isolation of a lung segment or reduction of lung volume is desired. The methods are minimally invasive with instruments being introduced through the mouth (endotracheally) and rely on isolating the target lung tissue segment from other regions of the lung and occluding various lung passageways with the use of occlusal stents. The occlusal stents are delivered with the use of an occlusal stent delivery system which is loaded with the occlusal stent with the use of an occlusal stent loading system.

1 . A delivery system for delivering an occlusal stent to a target lung passageway comprising: 
 a placement instrument configured for endobronchial advancement into a lung passageway leading to the target lung passageway, the instrument having a proximal end, a distal end, a working lumen extending therethrough;    a delivery catheter having a proximal end, a distal end and a receptacle formable within its distal end for loading the occlusal stent therein, the delivery catheter configured to be advanced through the working lumen of the placement instrument so that its distal end extends beyond the distal end of the placement instrument, and wherein its distal end is retractable so that retraction of its distal end releases the occlusal stent to the target lung passageway; and    a clamp connector attachable to the working lumen and having a passageway that allows passage of the delivery catheter through the passageway and into the working lumen of the placement instrument.    
     
     
         2 . A delivery system as in  claim 1 , wherein the placement instrument comprises a visualization element and an occlusive element near its distal end.  
     
     
         3 . A delivery system as in  claim 2 , wherein the delivery catheter includes a handle and the clamp connector includes a locking mechanism which is capable of locking the handle of the delivery catheter to the clamp connector.  
     
     
         4 . A delivery system as in  claim 2 , wherein the clamp connector comprises a connector body having a first end, a second end and an arc-shaped arm connecting the first and second ends, and wherein the passageway passes through the first and second ends.  
     
     
         5 . A delivery system as in  claim 1 , wherein the delivery catheter comprises a positioning rod, a tubular shaft extending from its proximal end to its distal end, and a handle positioned at its proximal end, wherein the positioning rod is disposed within the tubular shaft and is fixedly attached to the handle.  
     
     
         6 . A delivery system as in  claim 5 , wherein the tubular shaft is slidable in relation to the positioning rod.  
     
     
         7 . A delivery system as in  claim 6 , wherein the receptacle has an axial length and is formable within the tubular shaft distal to the distal end of the positioning rod.  
     
     
         8 . A delivery system as in  claim 7 , wherein the tubular shaft is configured so that sliding of the tubular shaft shortens the axial length of the receptacle exposing the occlusal stent.  
     
     
         9 . A delivery system as in  claim 8 , further comprising the occlusal stent wherein the occlusal stent is self-expanding so that release of the occlusal stent deploys the occlusal stent within the lung passageway.  
     
     
         10 . A delivery system as in  claim 5 , wherein the positioning rod comprises a main body coil extending along the positioning rod terminating at a plunger tip.  
     
     
         11 . A delivery system as in  claim 1 , wherein the visualization instrument comprises a bronchoscope.  
     
     
         12 . A delivery system as in  claim 11 , wherein the visualization instrument further comprises a sheath having a proximal end, a distal end, a lumen extending therethrough and the occlusive member disposed near its distal end, the lumen configured to receive the bronchoscope so that the occlusive member is disposed near the distal end of the bronchoscope.  
     
     
         13 . A delivery system as in  claim 12 , wherein the sheath comprises a flexible tubular body having a length in the range from 40 cm to 70 cm, an inside lumen diameter in the range from 1.5 mm to 10 mm, and a wall thickness in the range from 0.3 mm to 0.7 mm.  
     
     
         14 . A delivery system as in  claim 1 , wherein the distal end of the delivery catheter has portions of variable flexibility.  
     
     
         15 . A delivery system as in  claim 1 , further comprising the occlusal stent, wherein the occlusal stent is self expanding to a configuration which occludes the target lung passageway.  
     
     
         16 . A delivery system as in  claim 15 , wherein the occlusal stent is self expanding in free space to a configuration that has an approximately 11 mm outer diameter.  
     
     
         17 . A delivery system as in  claim 15 , wherein the occlusal stent comprises a wire structure at least partially encapsulated in a polymer.  
     
     
         18 . A loading system comprising: 
 an occlusal stent that is transitionable between an expanded configuration and a contracted configuration;    a loading body having a wide-mouthed end and a narrow-mouthed end, wherein the wide-mouthed end is configured to receive the occlusal stent in the expanded configuration and the narrow-mouthed end is configured to hold the occlusal stent in the contracted configuration; and    a loading mandrel having a proximal end, a distal end, and an attachment device disposed near its distal end that is removably attachable to the occlusal stent, wherein the mandrel is configured to load the removably attached occlusal stent into the wide-mouthed end and move the occlusal stent to the narrow-mouthed end.    
     
     
         19 . A loading system as in  claim 18 , wherein the loading body comprises a loading receptacle within the wide-mouthed end, wherein the loading receptacle is sized to receive the occlusal stent in the expanded configuration.  
     
     
         20 . A loading system as in  claim 19 , wherein the loading receptacle has a diameter in the range of approximately 10 to 13 mm.  
     
     
         21 . A loading system as in  claim 19 , wherein the loading body comprises a holding tube within the narrow-mouthed end, wherein the holding tube is sized to receive the occlusal stent in the contracted configuration.  
     
     
         22 . A loading system as in  claim 21 , wherein the holding tube has a diameter in the range of approximately 2 to 2.5 mm.  
     
     
         23 . A loading system as in  claim 21 , wherein the loading body comprises a restrictor disposed between the loading receptacle and the holding tube, wherein the restrictor has a funnel shape to transition the occlusal stent from the expanded configuration to the contracted configuration.  
     
     
         24 . A loading system as in  claim 18 , wherein the loading mandrel includes a first marking near its distal end and the loading body includes a second marking near its narrow-mouthed end, wherein alignment of the first marking with the second marking positions the occlusal stent within the narrow-mouthed end.  
     
     
         25 . A loading system as in  claim 18 , further comprising a delivery catheter having a proximal end, a distal end and a receptacle formable within its distal end for loading the occlusal stent therein.  
     
     
         26 . A loading system as in  claim 25 , wherein the narrow-mouthed end of the loading body is configured to mate with the distal end of the delivery catheter.  
     
     
         27 . A loading system as in  claim 26 , wherein the loading mandrel is configured to move the occlusal stent from the narrow-mouthed end to the receptacle within the distal end of the delivery catheter.  
     
     
         28 . A system as in  claim 18 , wherein the attachment device comprises a hook, fork, clasp, fastener or magnet.  
     
     
         29 . A method of delivering an occlusal stent to a lung passageway within a lung of a patient comprising: 
 providing a visualization instrument, wherein the instrument has a proximal end, distal end, a working lumen therethrough, means for visualization near the distal end, and an occlusive member disposed near its distal end which is configured to be expandable to occlude the lung passageway;    advancing the visualization instrument through a trachea of the patient to a first location within the lung passageway;    occluding the lung passageway at the first location with the occlusive member;    evacuating the lung passageway;    providing a delivery catheter having a proximal end, a distal end, and an occlusal stent loaded within a receptacle in its distal end;    advancing the delivery catheter through the working lumen of the visualization instrument so that the distal end of the delivery catheter extends beyond the distal end of the bronchoscope to a second location within the lung passageway; and    retracting the distal end of the delivery catheter which releases the occlusal stent from the receptacle at the second location within the evacuated lung passageway.    
     
     
         30 . A method as in  claim 29 , wherein the lung passageway comprises a main passageway and at least one branch passageway, wherein the first location is disposed within the main passageway and the second location is disposed within one of the at least one branch passageways.  
     
     
         31 . A method as in  claim 30 , further comprising withdrawing the delivery catheter from the visualization instrument after releasing the occlusal stent while the lung passageway remains evacuated.  
     
     
         32 . A method as in  claim 31 , further comprising: 
 providing another delivery catheter having a proximal end, a distal end, and another occlusal stent loaded within a receptacle within its distal end; and    advancing the another delivery catheter through the working lumen of the visualization instrument so that the distal end of the another delivery catheter extends beyond the distal end of the instrument to a third location within the evacuated lung passageway.    
     
     
         33 . A method as in  claim 32 , wherein the third location is disposed within another of the at least one branch passageways.  
     
     
         34 . A method as in  claim 29 , wherein the delivery catheter comprises a tubular shaft extending from its proximal end to its distal end, and wherein the occlusal stent is disposed within the tubular shaft, and wherein releasing comprises withdrawing the tubular shaft to expose the occlusal stent.  
     
     
         35 . A method as in  claim 34 , wherein the delivery catheter comprises a handle disposed at its proximal end, and wherein the tubular shaft is slidably connected with the handle by a handle button, wherein withdrawing comprises moving the handle button to withdraw the tubular shaft.  
     
     
         36 . A method as in  claim 29 , wherein the visualization instrument has a handle near its proximal end, further comprising connecting a clamp connector to the handle of the instrument.  
     
     
         37 . A method as in  claim 36 , wherein the clamp connector has a passageway, and wherein advancing the delivery catheter comprises passing the distal end of the delivery catheter through the passageway of the clamp connector and into the working lumen of the instrument.  
     
     
         38 . A method as in  claim 37 , wherein the delivery catheter comprises a tubular shaft extending from its proximal end to its distal end and a handle disposed at its proximal end, and wherein the clamp connector has a locking mechanism, the method further comprising actuating the locking mechanism to lock the handle of the delivery catheter to the clamp connector.  
     
     
         39 . A method as in  claim 38 , wherein the tubular shaft is slidably connected with the handle of the catheter by a handle button, wherein releasing comprises moving the handle button to withdraw the tubular shaft and expose the occlusal stent.  
     
     
         40 . A method as in  claim 29 , wherein releasing comprises expanding the occlusal stent to occlude the lung passageway.  
     
     
         41 . A method comprising: 
 providing a loading mandrel having a proximal end, a distal end and an occlusal stent removably attached to its distal end, wherein the occlusal stent is transitionable between an expanded configuration and a contracted configuration;    providing a loading body having a wide-mouthed end and a narrow-mouthed end, wherein the wide-mouthed end is configured to receive the occlusal stent in the expanded configuration and the narrow-mouthed end is configured to hold the occlusal stent in the contracted configuration;    positioning the loading mandrel within the loading body so that the occlusal stent is near the wide-mouthed end; and    manipulating the loading mandrel to load the occlusal stent into the wide-mouthed end and move the occlusal stent to the narrow-mouthed end within the loading body.    
     
     
         42 . A method as in  claim 41 , wherein the loading body comprises a loading receptacle within the wide-mouthed end, and wherein manipulating the loading mandrel comprises moving the loading mandrel relative to the loading body so that the occlusal stent is positioned within the loading receptacle.  
     
     
         43 . A method as in  claim 42 , wherein the loading body includes a restrictor adjacent to the loading receptacle, and wherein manipulating the loading mandrel comprises moving the loading mandrel relative to the loading body so that the occlusal stent enters the restrictor.  
     
     
         44 . A method as in  claim 43 , wherein the loading body includes a holding tube adjacent to the restrictor, and wherein manipulating the loading mandrel comprises moving the loading mandrel relative to the loading body so that the occlusal stent is positioned within the holding tube.  
     
     
         45 . A method as in  claim 41 , wherein the loading mandrel includes a first marking near its distal end and the loading body includes a second marking near its narrow-mouthed end, further comprising aligning the first marking with the second marking indicating that the occlusal stent is positioned within the narrow-mouthed end.  
     
     
         46 . A method as in  claim 41 , further comprising detaching the occlusal stent from the loading mandrel.  
     
     
         47 . A method as in  claim 45 , further comprising: 
 providing a delivery catheter having a proximal end, a distal end and a receptacle formable within its distal end for loading the occlusal stent therein; and    transferring the occlusal stent from the narrow-mouthed end of the loading body to the receptacle of the delivery catheter.    
     
     
         48 . A method as in  claim 46 , further comprising mating the distal end of the delivery catheter with the narrow-mouthed end of the loading body prior to the transferring step.  
     
     
         49 . A method as in  claim 47 , wherein transferring comprises advancing the loading mandrel through the open-mouthed end of the loading body which pushes the occlusal stent into the distal end of the delivery catheter.  
     
     
         50 . A clamp connector comprising: 
 a connector body having a first end, a second end and a passageway therethrough, the passageway configured to receive at least a portion of a catheter; and    a fitting on the first end for attaching the connector body to a handle of a visualization instrument, the visualization instrument having a proximal end, a distal end, a working lumen extending therethrough, means for visualization near the distal end and the handle disposed near its proximal end so that attachment of the connector body to the handle joins the passageway with the working lumen to allow advancement of the catheter from the passageway into the working lumen.    
     
     
         51 . A clamp connector as in  claim 50 , further comprising a locking mechanism configured to lock the at least a portion of a catheter to the connector body which holds the at least a portion of the catheter relative to the visualization instrument  
     
     
         52 . A clamp connector as in  claim 50 , wherein the connector body further includes an arm connecting the first end to the second end to form a C-shape.  
     
     
         53 . A clamp connector as in  claim 50 , wherein the fitting comprises a quick connector.  
     
     
         54 . A clamp connector as in  claim 53 , wherein the quick connector comprises a side-action quick connector which allows the connector to be attached and detached from a side approach.  
     
     
         55 . A clamp connector as in  claim 50 , wherein the locking mechanism tightens the passageway through the connector body to hold the at least a portion of the catheter by frictional forces.  
     
     
         56 . A clamp connector as in  claim 55 , wherein the locking mechanism comprises a screw, knob or tensioning lever.  
     
     
         57 . A clamp connector comprising: 
 a connector body having a passageway therethrough; and    means for connecting the connector body to a visualization instrument having a working lumen so that insertion of an instrument through the passageway of the connector body inserts the instrument into the working lumen of the visualization instrument.    
     
     
         58 . A clamp connector as in  claim 57 , wherein the visualization instrument comprises a bronchoscope.  
     
     
         59 . A clamp connector as in  claim 57 , wherein the passageway and the working lumen are non-axially aligned during connection.  
     
     
         60 . A clamp connector as in  claim 57 , wherein the means for connecting comprises a fitting.  
     
     
         61 . A clamp connector as in  claim 60 , wherein the fitting comprises a quick connector.  
     
     
         62 . A clamp connector as in  claim 57 , further comprising a locking mechanism configured to lock the at least a portion of an instrument to the connector body which holds the at least a portion of the instrument relative to the visualization instrument.  
     
     
         63 . A delivery system for delivering an implant to a target location within a body comprising: 
 an access instrument configured for advancement to the target location, the instrument having a proximal end, a distal end, a working lumen extending therethrough and an access port communicating with the working lumen;    a delivery catheter comprising a shaft having a proximal end, a distal end and a receptacle within its distal end for holding the implant, the delivery catheter configured to be advanced into the working lumen of the access instrument, the catheter further comprising an inner core axially movable relative to the shaft; and    a positioning mechanism attachable to the proximal end of the access instrument and further attachable to the inner core of the catheter.    
     
     
         64 . A system as in  claim 63 , wherein the positioning mechanism is attachable to the proximal end of the access instrument while the shaft is movable relative to the inner core and access instrument so as to release the implant from the receptacle.  
     
     
         65 . A system as in  claim 63 , wherein the positioning mechanism is attachable to the proximal end of the access instrument while the inner core is movable relative to the shaft and the access instrument so as to release the implant from the receptacle.  
     
     
         66 . A system as in  claim 65 , wherein the delivery catheter includes a handle near its distal end, the handle insertable a distance into the visualization instrument.