Methods, devices and therapeutic platform for automated, selectable, soft tissue resection

Abstract

An excisional device may comprise an introducer comprising a distal trough portion and a cutting assembly. The cutting assembly may comprise an axial band element configured to selectively bow out of and away from the distal trough portion and to retract into the distal trough portion and a helical cutting element wound around the axial band element. A rotating drum may be provided to cause the cutting assembly to selectively rotate, bow and retract according to a mechanically-driven first cutting profile that is defined by a shape of a channel formed in the drum. An optical guidance projector assembly may be coupled to the excisional device and may be configured to visually indicate when a distal portion of the excisional device is aligned with an imaging plane of an imaging probe and in a desired position.

1 . An excisional device, comprising:
 an introducer comprising a distal trough portion; and   a cutting assembly, comprising:
 an axial band element configured to selectively bow out of and away from the distal trough portion and to retract into the distal trough portion; and 
 a helical cutting element wound around the axial band element. 
   
     
     
         2 . The excisional device of  claim 1 , wherein the cutting assembly is removable from the introducer. 
     
     
         3 . The excisional device of  claim 1 , wherein a distal portion of the cutting assembly is configured to pivot against a distal portion of the introducer as it bows out of and retracts back into the distal trough portion of the introducer. 
     
     
         4 . The excisional device of  claim 1 , wherein the distal trough portion comprises at least one abutment at or near a distal end thereof, the at least one abutment being configured to enable a distal portion of the cutting assembly to pivot relative to the introducer as the cutting assembly bows out of and retracts back into the distal trough portion thereof. 
     
     
         5 . The excisional device of  claim 1 , further comprising a driving assembly that is configured to at least one of rotate, bow and retract the cutting assembly. 
     
     
         6 . The excisional device of  claim 1 , wherein at least a portion of the cutting assembly is energized with radiofrequency energy. 
     
     
         7 . The excisional device of  claim 1 , wherein the axial band is further configured to enable fluids to be evacuated from and delivered to a excisional procedure site. 
     
     
         8 . The excisional device of  claim 1 , further comprising a plurality of first fenestrations disposed within the axial band that are configured to enable fluids to be evacuated from an excisional procedure site and a plurality of second fenestrations disposed within the axial band element that are configured to enable fluids to be evacuated from the excisional procedure site. 
     
     
         9 . The excisional device of  claim 1 , further comprising a collection assembly comprising an initially furled bag mounted to a distal end thereof, wherein the collection assembly is configured to be inserted into the introducer, to unfurl the bag and to enable collection of a cut tissue specimen therein. 
     
     
         10 . The excisional device of  claim 9 , wherein the collection assembly further comprises a hoop mounted to the distal end thereof, the hoop being configured to bend away from a longitudinal axis of the collection assembly and to unfurl the bag. 
     
     
         11 . The excisional device of  claim 1 , wherein the cutting assembly is further configured to cut a volume of revolution along having a predetermined shape dictated by a mechanically-driven cutting profile. 
     
     
         12 . The excisional device of  claim 1 , further configured to deliver an implantable material to an excisional procedure site. 
     
     
         13 . The excisional device of  claim 1 , wherein the distal trough portion is scoopula-shaped. 
     
     
         14 . The excisional device of  claim 1 , wherein the introducer and the cutting assembly are configured to cut tissue with substantially no dead space at a distal end of the device. 
     
     
         15 . The excisional device of  claim 14 , wherein a distal end of the cutting assembly is coupled to a distal end of the introducer such that the cutting assembly is configured to bow out to an extent that reduces the dead space substantially to zero. 
     
     
         16 . The excisional device of  claim 1 , further comprising a guide assembly over which the introducer may be introduced into tissue, the guide assembly comprising a tube portion and defining a distal end; at least one distal stabilizing projection configured to emerge from the tube portion at the distal end, to flex outward away from a longitudinal axis of the tube portion and to stabilize a position of the guide assembly within tissue; and at least one injecting tube configured to emerge from the tube portion at the distal end and to deliver one or more agents to the tissue. 
     
     
         17 . The excisional device of  claim 1 , wherein the introducer is configured to be introduced into tissue without the cutting assembly and wherein the cutting assembly is further configured to be inserted within the introducer after the introducer is inserted into tissue. 
     
     
         18 . The excisional device of  claim 1 , further comprising an ultrasound device configured to be inserted within the introducer. 
     
     
         19 . An excisional device, comprising:
 an introducer comprising a distal trough portion;   a cutting assembly configured to rotate and to selectively bow out of and away from the distal trough portion and to retract into the distal trough portion;   a drum configured to rotate and comprising a first channel;   a follower configured to move within the first channel and to cause the cutting assembly to selectively rotate, bow and retract according to a mechanically-driven first cutting profile that is defined by a shape of the first channel.   
     
     
         20 . The excisional device of  claim 19 , wherein the drum comprises a second channel, wherein the follower is further configured to selectively move within the second channel and to cause the cutting assembly to selectively rotate, bow and retract according to a mechanically-driven second cutting profile that is defined by a shape of the second channel. 
     
     
         21 . The excisional device of  claim 20 , wherein the first and second cutting profiles each define a predetermined revolution sweep angle of the cutting assembly. 
     
     
         22 . The excisional device of  claim 19 , wherein at least the cutting assembly is configured to be one of manually driven and actuated by an electric motor. 
     
     
         23 . An excisional biopsy system, comprising:
 an excisional device comprising a proximal body portion and a distal portion that is configured to be placed within tissue and to obtain a tissue specimen therefrom; and   an optical guidance projector assembly coupled to the proximal body portion of the excisional device, the optical guidance projector assembly being configured to project, onto a probe, visible indicia configured to indicate at least when the distal portion is aligned with an imaging plane of the probe.   
     
     
         24 . The excisional biopsy system of  claim 23 , further comprising a reflective guidance sensor strip configured to affixed to the probe and configured to reflect the visible indicia projected by the optical guidance projector assembly. 
     
     
         25 . The excisional biopsy system of  claim 24 , wherein the reflective guidance sensor strip comprises at least one optical sensing element. 
     
     
         26 . The excisional biopsy system of  claim 23 , wherein the optical guidance projector assembly is configured to project a pattern of dots onto the probe as the visible indicia. 
     
     
         27 . The excisional biopsy system of  claim 23 , wherein the probe is an ultrasound probe and wherein the imaging plane of the probe is an ultrasound imaging plane. 
     
     
         28 . The excisional biopsy device of  claim 23 , wherein the optical guidance projector assembly is configured to project optical indicia indicative of the distal portion being directly under a center of the probe. 
     
     
         29 . The excisional biopsy system of  claim 23 , wherein the optical guidance projector assembly is configured to couple to an ultrasound imaging system configured to interpret and display at least one of projected trajectory, orientation and positioning information obtained from the optical guidance projector assembly. 
     
     
         30 . The excisional biopsy system of  claim 23 , wherein the optical guidance projector assembly is configured to provide a visible feedback to guide the distal portion to a desired placement and orientation within the tissue. 
     
     
         31 . A method of performing an excisional procedure, comprising:
 inserting, in a first orientation, a distal portion of an excisional device to a first location in tissue, the excisional device comprising an optical guidance projector assembly mounted thereon;   disposing an imaging probe over the tissue;   projecting visible indicia from the optical guidance projector onto a surface of the imaging probe;   carrying out at least one of:
 moving the excisional device from the first orientation to a second orientation based upon the visible indicia projected upon the surface of the imaging probe; and 
 moving the excisional device from the first location to a second location based upon the visible indicia projected upon the surface of the imaging probe. 
   
     
     
         32 . The method of  claim 31 , wherein the optical guidance projector assembly is configured to project a plurality of dots of light onto the surface of the imaging probe. 
     
     
         33 . The method of  claim 31 , further comprising moving the excisional device until the plurality of dots projected onto the surface of the imaging probe indicate that the distal portion of the excisional device is aligned with an imaging plane of the probe. 
     
     
         34 . The method of  claim 31 , further comprising affixing a reflective guidance sensor strip onto the probe, the reflective guidance sensor strip being configured to reflect the visible indicia projected by the optical guidance projector. 
     
     
         35 . The method of  claim 31 , wherein the reflective guidance sensor strip comprises at least one optical sensing element that is responsive to the visible indicia projected onto the surface of the probe and wherein the method further comprises feeding an output of the at least one optical sensing element to an imaging system. 
     
     
         36 . The method of  claim 31 , further comprising the imaging system interpreting the output of the at least one optical sensing element and displaying the interpreted output on a display. 
     
     
         37 . The method of  claim 36 , further comprising changing the displayed interpreted output as the excisional device is moved. 
     
     
         38 . The method of  claim 31 , wherein the probe is an ultrasound probe and wherein the method comprises the visible indicia indicating when the distal portion of the excisional device is aligned with an ultrasound imaging plane of the ultrasound probe. 
     
     
         39 . A soft tissue guide assembly, comprising:
 a tube portion defining a longitudinal axis and a distal end   at least one distal stabilizing projection disposed within the tube portion and configured to emerge from the tube portion at the distal end, to flex outward away from the longitudinal axis of the tube portion and to stabilize a position of the guide assembly within tissue; and   at least one injecting tube disposed within the tube and configured to emerge from the tube portion at the distal end and to deliver one or more devices, agents or materials to the tissue.   
     
     
         40 . The soft tissue guide assembly of  claim 39 , further configured to enable at least one device to be introduced into the tissue there over. 
     
     
         41 . The soft tissue guide assembly of  claim 39 , wherein the at least one distal stabilizing projection is biased to bow out in an arc away from the longitudinal axis of the tube portion at the distal end thereof. 
     
     
         42 . The soft tissue guide assembly of  claim 39 , wherein the at least one injecting tube is biased to bow out in an arc away from the longitudinal axis of the tube portion at the distal end thereof 
     
     
         43 . The soft tissue guide assembly of  claim 39 , wherein the at least one stabilizing projections and the at least one injecting tube are configured to be retracted within the tube portion.