Delivery applicator for radioactive staples for brachytherapy medical treatment

Abstract

An instrument used for brachytherapy delivery in the treatment of cancer by radiation therapy including a handle having first and second handle actuators; an end effector; and an instrument shaft that connects the handle with the end effector. The end effector has first and second adjacent disposed staple cartridges that each retain a set of staples. The first mechanism is for holding standard staples in a first array, and dispensing the standard staples under control of the corresponding first handle actuator. The second mechanism is for holding radioactive source staples in a second array, and dispensing said radioactive source staples under control of the corresponding second handle actuator. The actuating device is removably attachable to an actuator arm on a proximal end. A staple applicator cartridge holder is attached to the actuator arm on a distal end. The staple applicator cartridge is mountable in the holder and having a plurality of slots for mounting of radioactive source staples therein. An anvil therein crimps the staples.

1 . An instrument used for brachytherapy delivery in the treatment of cancer by radiation therapy, said instrument comprising:
 a handle having first and second handle actuators;   an end effector;   an instrument shaft that connects the handle with the end effector;   said end effector comprised of first and second adjacent disposed cartridges that each retain a set of staples;   said first cartridge for holding standard staples in a first array, and dispensing said standard staples under control of the corresponding first handle actuator;   said second cartridge for holding radioactive source staples in a second array, and dispensing said radioactive source staples under control of the corresponding second handle actuator;   said first and second cartridges being retained in a substantially parallel array so that the standard staples close the incision at a surgical margin while the source staples are secured adjacent thereto.   
     
     
         2 . The instrument of  claim 1  wherein both of said arrays of staples are disposed spaced both longitudinally and laterally. 
     
     
         3 . The instrument of  claim 1  wherein said staples are constructed of any one of platinum, titanium, nickel-titanium alloys, gold, stainless steel, palladium, silica and alumina. 
     
     
         4 . The instrument of  claim 1  wherein the staples of both arrays are spaced apart about 1.0 mm both longitudinally and laterally. 
     
     
         5 . The instrument of  claim 1  wherein said standard staples are positionable for piercing said tissue in performing a surgical procedure at a surgical margin while substantially concurrently said source staples secure said radioactive source in a fixed position at said surgical margin. 
     
     
         6 . The instrument of  claim 5  wherein said array of source staple is constructed and arranged to extend spaced longitudinally of the surgical margin. 
     
     
         7 . The instrument of  claim 1  wherein the radioactive source is for cancer treatment and the standard staples are applied followed by applying the source staples. 
     
     
         8 . The instrument of  claim 7  wherein a complete line of standard staples are applied followed by a complete line of source staples. 
     
     
         9 . An instrument used as a brachytherapy delivery means in the treatment of cancer by radiation therapy, said apparatus comprising:
 a control handle;   an end effector;   an instrument shaft that connects the control handle with the end effector;   said end effector comprised of first and second adjacently disposed cartridges that each retain a set of staples;   said first cartridge for holding standard staples in a first array, and dispensing said standard staples under operation from said control handle;   said second cartridge for holding radioactive source staples in a second array;   said source staples each comprised of a base, tissue piercing ends, a radioactive source, and means for mounting the radioactive source to the base;   said second cartridge for dispensing said source staples under operation from said control handle;   said cartridges for retaining and selectively applying the staples along a surgical margin so that the standard staples close the incision at a surgical margin while the source staples are secured adjacent thereto.   
     
     
         10 . The instrument of  claim 9  including a distal holder for retaining the first and second cartridges in a substantially parallel array. 
     
     
         11 . The instrument of  claim 10  wherein each cartridge control handle also has respective first and second handle actuators for controlling the application of staples. 
     
     
         12 . The instrument of  claim 9  wherein said source staples fix the position of the radioactive source relative to the surgical martin to provide a stable dose distribution thereat. 
     
     
         13 . A staple delivery applicator for delivering radioactive source staples during a medical treatment, said staple delivery applicator comprising:
 an actuating means, said actuating means for controlling crimping of the source staples located distally from said actuating means;   an actuator arm, said actuating means being removably attachable to said actuator arm on a proximal end; and   a cartridge holder, said cartridge holder operatively attached to said actuator arm on a distal end and adapted to removably mount therein a source staple cartridge;   wherein said actuating means is adapted for closing the anvil of the cartridge holder and for firing of the source staples in the cartridge therein to cause the staples to crimp, and opening and closing of the anvil.   
     
     
         14 . The staple delivery applicator for delivering radioactive source staples as recited in  claim 13 , wherein said actuating means comprises a device operated by hand, by mechanical means, or electrical/mechanical means. 
     
     
         15 . The staple delivery applicator as recited in  claim 14 , wherein said mechanical means comprises a trigger device comprising:
 a hand holding section, a lever mounted in said hand holding section;   a control section, said control section having one or more controls therein thereon for crimping staples located distally from said trigger device, said control section having a control for closing the anvil of the cartridge holder and for firing of the source staples in the cartridge therein to cause the staples to crimp, and a control for opening the anvil and releasing the trigger device from the actuator arm; and   an actuator arm mounting section.   
     
     
         16 . The staple delivery applicator as recited in  claim 13 , wherein said actuator arm has a proximal end and a distal end, said proximal end having a control cable extending therefrom which is mountable in said actuator arm mounting section, said distal end being adapted to mount to said cartridge holder. 
     
     
         17 . The staple delivery applicator as recited in  claim 13 , wherein said cartridge holder further includes said anvil and a firing hammer, said firing hammer being translatable within said staple cartridge, said firing hammer operatively pushing upwards upon one or more staple holders mounted therein, said pushing crimping the legs of staples against said anvil. 
     
     
         18 . The staple delivery applicator as recited in  claim 13 , wherein said staple cartridge may be removably attached to said cartridge holder, said staple cartridge having a plurality of slots for mounting of radioactive source staples therein, said anvil for crimping the staples therein. 
     
     
         19 . The staple delivery applicator as recited in  claim 13 , further including a connector, said staple holder being adapted for removably mounting in said connector, said connector being removably mounted to a surgical staple holder. 
     
     
         20 . The staple delivery applicator as recited in  claim 19 , wherein said connector may be mounted to one side or the other side of said surgical staple holder. 
     
     
         21 . The staple delivery applicator as recited in  claim 20 , wherein said connector further includes radiation shielding. 
     
     
         22 . The staple delivery applicator as recited in  claim 13 , further including a modular connector with two modular units, one modular unit being adapted to removably hold said source staple cartridge holder, the other modular unit being adapted to removably hold a surgical staple cartridge holder, said units being removably mounted together in said modular connector when in use. 
     
     
         23 . The staple delivery applicator as recited in  claim 21 , wherein said modular unit for said cartridge holder may be mounted to either side of the modular unit for holding said surgical staple holder. 
     
     
         24 . The staple delivery applicator as recited in  claim 23 , wherein said connector further includes radiation shielding. 
     
     
         25 . The staple delivery applicator as recited in  claim 13 , said anvil further includes radiation shielding. 
     
     
         26 . A staple delivery applicator for delivering radioactive staples during medical treatment, said staple delivery applicator comprising:
 an actuating means, said actuating means for controlling crimping of the source staples located distally from said actuating means;   an actuator arm, said actuating means being removably attachable to said actuator arm on a proximal end;   a cartridge holder, said cartridge holder operatively attached to said actuator arm on a distal end and adapted to removably mount therein a source staple cartridge;   a connector, said staple holder being adapted to removably mount in said connector;   wherein said actuating means is adapted for closing the anvil of the cartridge holder and for firing of the source staples in the cartridge therein to cause the staples to crimp, and opening and closing of the anvil.   
     
     
         27 . The staple delivery applicator for delivering radioactive source staples as recited in  claim 26 , wherein said actuating means comprises a device operated by hand, by mechanical means, or electrical/mechanical means. 
     
     
         28 . The staple delivery applicator as recited in  claim 27 , wherein said mechanical means comprises a trigger device comprising:
 a hand holding section, a lever mounted in said hand holding section;   a control section, said control section having one or more controls therein thereon for crimping staples located distally from said trigger device, said control section having a control for closing the anvil of the cartridge holder and for firing of the source staples in the cartridge therein to cause the staples to crimp, and a control for opening the anvil and releasing the trigger device from the actuator arm; and   an actuator arm mounting section.   
     
     
         29 . The staple delivery applicator as recited in  claim 26 , wherein said connector may be mounted to one side or the other side of said surgical staple holder. 
     
     
         30 . The staple delivery applicator as recited in  claim 26 , wherein said connector further includes radiation shielding. 
     
     
         31 . The staple delivery applicator as recited in  claim 26 , further including a modular connector with two modular units, one modular unit being adapted to removably hold said cartridge holder, the other modular unit being adapted to removably hold a surgical staple cartridge holder, said units being removably mounted together in said modular connector when in use. 
     
     
         32 . The staple delivery applicator as recited in  claim 31 , wherein said modular unit for said cartridge holder may be mounted to either side of the modular unit for holding said surgical staple holder. 
     
     
         33 . The staple delivery applicator as recited in  claim 19 , wherein said modular connector further includes radiation shielding.