Methods and devices for cutting and collecting soft tissue

Abstract

A device for cutting and collecting a specimen from a mass of tissue may include a shaft, an integrated cut and collect assembly coupled to the shaft and an actuator. The shaft may define an opening and may include an outer surface that defines a trough adjacent the opening, the trough defining a ledge portion that is cut out of the shaft. The integrated cut and collect assembly may include an RF cutting portion and a collection portion that includes a flexible membrane, the collection portion being attached to the cutting portion, the integrated cut and collect assembly being configured to assume a retracted position at least partially within the opening such that part of the collection portion is disposed within the trough and in contact with the ledge portion and a selectable expanded position that extends through the opening and away from the shaft. The cutting portion may be configured to cut the specimen from the mass of tissue and the collection portion may be configured to collect the cut specimen and to isolate the cut specimen within the membrane. The trough may be configured to minimize contact of the cutting portion with the tissue to be cut as the cutting portion is becoming fully energized in the retracted position. The actuator may be coupled to the integrated assembly such that operation of the actuator causes a deployment of the integrated assembly from the retracted position to the selectable expanded position.

1 . A device for cutting and collecting a specimen from a mass of tissue, comprising:
 a shaft, the shaft defining an opening and including an outer surface that defines a trough adjacent the opening, the trough defining a ledge portion that is cut out of the shaft;   an integrated cut and collect assembly coupled to the shaft, the integrated cut and collect assembly including a cutting portion configured to be energized by RF energy and a collection portion that includes a flexible membrane, the collection portion being attached to the cutting portion, the integrated cut and collect assembly being configured to assume a retracted position at least partially within the opening such that part of the collection portion is disposed within the trough and in contact with the ledge portion and a selectable expanded position that extends through the opening and away from the shaft, the cutting portion being configured to cut the specimen from the mass of tissue and the collection portion being configured to collect the cut specimen and to isolate the cut specimen within the membrane, the trough being configured to minimize contact with the tissue to be cut while becoming fully energized in the retracted position, and   an actuator, the actuator being coupled to the integrated assembly such that operation of the actuator causes a deployment of the integrated assembly from the retracted position to the selectable expanded position.   
     
     
         2 . The device of  claim 1 , wherein the integrated cut and collect assembly assumes a bowed shape in the expanded position. 
     
     
         3 . The device of  claim 1 , wherein the thin flexible membrane is configured to at least partially encapsulate the cut specimen. 
     
     
         4 . The device of  claim 1 , wherein the thin flexible membrane is configured to encapsulate at least 40% of the specimen. 
     
     
         5 . The device of  claim 1 , wherein the cutting portion defines a cutting edge and a trailing edge and wherein the collection portion of the integrated cut and collect assembly extends from the trailing edge to the shaft. 
     
     
         6 . The device of  claim 1 , wherein the thin flexible membrane portion includes a polymeric material. 
     
     
         7 . The device of  claim 6 , wherein the polymeric material includes one of an organic, inorganic and organic-inorganic polymer. 
     
     
         8 . The device of  claim 6 , wherein the polymeric material includes a silicone or silicone-containing elastomer. 
     
     
         9 . The device of  claim 1 , wherein the integrated cut and collect assembly includes an RF cutting portion. 
     
     
         10 . The device of  claim 1 , wherein the cutting portion is configured to be energized by an RF energy source. 
     
     
         11 . The device of  claim 1 , wherein the flexible membrane is substantially non-conductive in tissue and includes an RF resistant material. 
     
     
         12 . The device of  claim 1 , wherein the flexible membrane includes a teraphthalate, a tetrafluoroethylene, a polytetrafluoroethylene, a polymide, a polyester, Kevlar® and M5®. 
     
     
         13 . The device of  claim 1 , wherein the flexible membrane has a laminar structure that includes a reinforcing layer. 
     
     
         14 . The device of  claim 13 , wherein the reinforcing layer includes at least one of polyester, polyurethane and polyimide. 
     
     
         15 . The device of  claim 13 , wherein a layer of silicone or silicone-containing elastomer is disposed between the reinforcing layer and a point of contact with the tissue cutting portion. 
     
     
         16 . The device of  claim 1 , wherein the flexible membrane is shaped like a bag. 
     
     
         17 . The device of  claim 1 , wherein the flexible membrane is fluid-tight. 
     
     
         18 . The device of  claim 1 , wherein the actuator is effective to simultaneously operate the cutting and the collection portions of the integrated cut and collect assembly. 
     
     
         19 . The device of  claim 1 , wherein expansion of the cutting portion causes an expansion of the collection portion of the integrated cut and collect assembly. 
     
     
         20 . The device of  claim 1 , wherein the integrated cut and collect assembly is configured as a single loop that expands and retracts upon operation of the actuator. 
     
     
         21 . The device of  claim 1 , wherein the cutting portion includes a braided leading edge. 
     
     
         22 . The device of  claim 21 , wherein the cutting portion defines a braided metallic tube. 
     
     
         23 . The device of  claim 22 , wherein the collection portion is attached to the braided metallic tube. 
     
     
         24 . The device of  claim 1 , wherein the cutting portion includes a metallic braided cutter disposed around a mandrel that supports the collection portion of the integrated cut and collect assembly. 
     
     
         25 . The device of  claim 1 , wherein the collection portion defines a flexible membrane that includes a locally thicker portion around which the cutting portion is crimped. 
     
     
         26 . The device of  claim 1 , wherein the cutting portion includes first and second metallic ribbons disposed so as to sandwich a portion of the flexible membrane therebetween. 
     
     
         27 . The device of  claim 26 , wherein the first metallic ribbon is attached to the second metallic ribbon through at least one of a rivet, a weld and a pin. 
     
     
         28 . The device of  claim 1 , wherein the cutting portion includes a metallic ribbon and wherein the flexible membrane is sewn onto the metallic ribbon. 
     
     
         29 . The device of  claim 1 , wherein the cutting portion includes a flat flexible metallic ribbon that defines a plurality of windows defining a centerline, and wherein the flat metallic ribbon is bent at the centerline around a portion of the collection portion. 
     
     
         30 . The device of  claim 1 , wherein the cutting portion includes a first ribbon and wherein the thin flexible membrane is attached to a second ribbon, both the first and second ribbon being mechanically coupled to one another and to the actuator. 
     
     
         31 . The device of  claim 30 , wherein the second ribbon is coupled to an RF energy source. 
     
     
         32 . The device of  claim 30 , wherein the second ribbon is disposed so as to at least partially overlap the first ribbon. 
     
     
         33 . The device of  claim 30 , further including a mechanical coupling between the first and second ribbons. 
     
     
         34 . The device of  claim 1 , wherein the cutting portion has a generally cylindrical shape that defines an internal lumen in which a first part of the collection portion is secured, a remaining part of the collection portion emerging from a slot defined in the cutting portion and being attached to the shaft. 
     
     
         35 . The device of  claim 34 , further including a flexible mandrel disposed within the internal lumen of the cutting portion, the first part of the flexible membrane being wrapped around the mandrel, a length of the mandrel being larger than a length of the slot. 
     
     
         36 . The device of  claim 1 , further including an inflatable balloon disposed on the shaft. 
     
     
         37 . The device of  claim 1 , wherein the inflatable balloon is configured to be inflated by one of a gas and a fluid. 
     
     
         38 . The device of  claim 1 , wherein the balloon is configured to massage the mass of tissue by pulsating the inflation of the balloon. 
     
     
         39 . The device of  claim 1 , wherein the inflatable balloon is configured as a cooling sleeve. 
     
     
         40 . The device of  claim 1 , wherein the inflatable balloon is configured as a tissue expander. 
     
     
         41 . The device of  claim 1 , wherein the inflatable balloon is configured to stabilize the device when inserted in tissue. 
     
     
         42 . The device of  claim 1 , wherein the inflatable balloon is configured to at least one of seal an incision through which the device is inserted and to provide hemostatis. 
     
     
         43 . The device of  claim 1 , wherein the inflatable balloon is configured to reduce capacitive coupling to reduce tissue heating. 
     
     
         44 . The device of  claim 1 , wherein the integrated cut and collect assembly is single use and disposable. 
     
     
         45 . The device of  claim 1 , wherein the shaft and the integrated cut and collect assembly are single use and disposable. 
     
     
         46 . The device of  claim 1 , wherein the device is single use and disposable. 
     
     
         47 . The device of  claim 1 , wherein the membrane of the collection portion is configured so as to enable the collected and isolated specimen to at least partially trail behind the device as the device is retracted from the mass of tissue. 
     
     
         48 . The device of  claim 1 , wherein the cutting portion includes a first ribbon and wherein the collecting portion includes a second ribbon and a tube encircling at least a portion of the second ribbon, the thin flexible membrane being attached to the tube and to an exterior surface of the device, both the first and second ribbon being mechanically coupled to one another and to the actuator. 
     
     
         49 . The device of  claim 1 , wherein the flexible membrane is attached to the collection portion by an adhesive. 
     
     
         50 . The device of  claim 49 , wherein the adhesive includes a cyanoacrylate. 
     
     
         51 . The device of  claim 1 , wherein the trough is configured to separate the integrated cut and collect assembly from the mass of tissue when the integrated assembly is in the retracted position. 
     
     
         52 . The device of  claim 1 , wherein the trough is configured to reduce thermal damage to the tissue to be cut while the cutting portion is energizing in the trough. 
     
     
         53 . The device of  claim 1 , wherein the membrane is disposed over the trough and attached to the shaft, the cut and collect assembly being configured so as to stretch the membrane open and closed as the cut and collect assembly is expanded and retracted, respectively. 
     
     
         54 . The device of  claim 1 , wherein the cut and collect assembly includes a single ribbon that is split into a cutting portion and a collecting portion, the flexible membrane being attached to the collecting portion and to the shaft. 
     
     
         55 . A method of cutting and isolating a specimen from a mass of tissue, comprising the steps of:
 inserting an instrument that includes a shaft, an actuator and an integrated cut and collect assembly into the mass of tissue, the shaft having an exterior surface that defines an opening and a trough adjacent the opening, the trough defining a ledge portion that is cut from the shaft, the integrated cut and collect assembly being coupled to the shaft and to the actuator such that operation of the actuator causes a deployment of the integrated assembly out of the opening from a retracted position at least partially within the shaft to a selectable expanded position away from the shaft, the assembly including a cutting portion and a collection portion that includes a thin flexible membrane, the collection portion being attached to the cutting portion, the cutting portion being configured to cut the specimen from the mass of tissue and the collection portion being configured to collect the cut specimen from the mass of tissue and to isolate the cut specimen from the mass of tissue within the membrane;   energizing the cutting portion using an RF energy source while the cutting portion is at least partially disposed within the trough and at least part of the collection portion disposed in contact with the ledge portion, the trough and the ledge portion being configured to minimize contact of the cutting portion with the tissue to be cut while the cutting portion is becoming fully energized in the retracted position;   isolating the specimen from surrounding tissue by cutting the specimen from the mass of tissue with the energized cutting portion and collecting the cut specimen within the flexible membrane of the collecting portion.   
     
     
         56 . The method of  claim 55 , wherein the isolating step is initiated by acting upon the actuator to cause a simultaneous deployment of both the cutting and collecting portions of the integrated cut and collect assembly. 
     
     
         57 . The method of  claim 55 , wherein the instrument further includes an inflatable balloon disposed on the shaft and wherein the method further includes inflating the balloon. 
     
     
         58 . The method of  claim 57 , wherein the inflating step is carried after the inserting step. 
     
     
         59 . The method of  claim 57 , wherein the inflating step inflates the balloon by one of a gas and a fluid. 
     
     
         60 . The method of  claim 57 , further including the step of massaging the mass of tissue by pulsating the inflation of the balloon. 
     
     
         61 . The method of  claim 57 , further comprising the step of cooling the inflatable balloon by inflating the balloon with cooled gas or fluid. 
     
     
         62 . The method of  claim 57 , further comprising the step of expanding the tissue by inflating the balloon. 
     
     
         63 . The method of  claim 57 , further comprising the step of stabilizing the device by inflating the balloon. 
     
     
         64 . The method of  claim 57 , further comprising at least one of a step of sealing an incision through which the instrument is inserted and providing hemostatis by inflating the balloon. 
     
     
         65 . The method of  claim 57 , further comprising the step of reducing tissue heating by reducing capacitive coupling through inflation of the balloon. 
     
     
         66 . A device for cutting and collecting a specimen from a mass of tissue, comprising:
 a shaft defining a proximal and a distal end;   a work assembly near the distal end of the shaft, the work assembly being configured to cut the specimen from the mass of soft tissue and to isolate the cut specimen from surrounding tissue;   a single actuator near the proximal end of the shaft, the single actuator being mechanically coupled to the work assembly such that rotation of the device and operation of the single actuator is effective to cut, collect and isolate the specimen from the mass of tissue as the device is rotated.   
     
     
         67 . The device of  claim 66 , wherein the device defines a longitudinal axis and wherein the actuator is configured to selectively slide along the longitudinal axis to selectively deploy and retract the work assembly. 
     
     
         68 . The device of  claim 66 , wherein the work assembly is configured to be energized by an RF energy source. 
     
     
         69 . The device of  claim 67 , wherein the device is further configured such that sliding the actuator toward the distal end deploys the work assembly and wherein sliding the actuator in the proximal position retracts the work assembly. 
     
     
         70 . The device of  claim 69 , wherein the work assembly is configured so that the collected specimen is isolated from the mass of tissue when the actuator is slid in the proximal position and the work element is retracted. 
     
     
         71 . Method of collecting a tissue specimen from a mass of tissue, comprising the steps of:
 inserting a surgical instrument into the mass of tissue to a target location within the mass of tissue, the instrument including a shaft and a work assembly near a distal end of the shaft, the work assembly being configured to controllably cut the specimen from the mass of soft tissue and to isolate the cut specimen from the mass of tissue within a tissue isolator;   controlling the work assembly of the surgical instrument to cut and isolate the specimen, and   retracting the instrument from the mass of tissue while the specimen is isolated within the tissue isolator and at least partially trails the distal end of the shaft.   
     
     
         72 . The method of  claim 71 , further including a step of making an incision into the mass of tissue prior to the inserting step, the instrument creating an insertion path defined between the incision and the target location and wherein the isolated specimen trails the distal end of the shaft within the insertion path during the retracting step. 
     
     
         73 . The method of  claim 71 , further including a step of making an incision into the mass of tissue prior to the inserting step, the incision making step making an incision that is only as large as needed to enable insertion of the distal end of the shaft into the mass of tissue and wherein the retracting step retracts the isolated specimen from the tissue mass without substantially enlarging the incision.