Fiberoptic-guided interstitial seed manual applicator and seed cartridge

Abstract

A method and apparatus for implanting seeds in or about a target area, such as a tumor, within a patient. The implantation device includes an implantation needle having a bore extending longitudinally therethrough from a proximal end to a distal end of the needle, the needle bore being adapted to permit at least one seed to pass therethrough. An elongated plunger extends longitudinally through the implantation device in aligned relation to the needle bore and is selectively movable in the longitudinal direction relative the needle from a retracted position spaced apart from the needle to an extended position wherein the plunger is advanced through the needle bore eject at least one of the seeds through the bore, out of the distal end of needle and into the target area. An optical device is carried by and operatively connected to the plunger to provide visual assistance to an operator of the implantation device to guide and verify implantation of the ejected seed into the target area. A seed cartridge is releasable connected to the implantation device to store unused seeds and to load the sees into the implantation device.

We claim:  
     
         1 . An implantation device for implanting seeds within or adjacent to a target area, such as a tumor, located within a patient, comprising: 
 an implantation needle having a bore extending longitudinally therethrough from a proximal end to a distal end of the needle, the needle bore being adapted to permit at least one seed to pass therethrough;    an elongated plunger extending longitudinally through the implantation device, the plunger being in aligned relation to the needle bore and being selectively movable in the longitudinal direction relative the needle from a retracted position spaced apart from the needle to an extended position wherein the plunger is advanced through the needle bore to eject at least one of the seeds through the bore, out of the distal end of needle and into the target area; and    an optical device carried by and operatively connected to the implantation device, the optical device providing visual assistance to an operator of the implantation device to guide and verify implantation of the ejected seed into the target area.    
     
     
         2 . The implantation device according to  claim 1 , wherein the optical device is at least temporarily positioned within the implantation device adjacent the distal end of the needle.  
     
     
         3 . The implantation device according to  claim 2 , wherein the optical device is carried by and operatively connected to the plunger so that when the plunger is selectively moved to the extended position, the optical device is carried by the plunger through the needle bore to a position proximate the distal end of the needle.  
     
     
         4 . The implantation device according to  claim 3 , wherein the optical device is a fiberoptic scope.  
     
     
         5 . The implantation device according to  claim 3 , wherein the optical device is an optical scope.  
     
     
         6 . The implantation device according to  claim 3 , further comprising an elongated outer sheath substantially enclosing the plunger, wherein the outer sheath is selectively movable in predetermined increments in the longitudinal direction relative the needle.  
     
     
         7 . The implantation device according to  claim 3 , further comprising an elongated inner sheath located within the outer sheath, the inner sheath substantially enclosing the plunger and at least a portion of the needle.  
     
     
         8 . The implantation device according to  claim 3 , further comprising: 
 an elongated member having a seed alignment channel extending longitudinally therethrough, the seed alignment channel adapted to retain the seeds in end-to-end aligned relation within the implantation device;    a seed transfer barrel having at least one seed chamber adapted to receive a single seed, the seed chamber being selectively movable from a loading position in aligned relation and communicating with the seed alignment channel to a firing position in aligned relation to the needle and plunger, wherein, in the loading position, a single seed may be advanced from the seed alignment channel into the seed chamber, and, in the firing position, the plunger may be selectively advanced through the seed chamber to eject the seed contained within the seed chamber out of the transfer barrel, through the needle bore and into the target area at the plunger moves from the retracted position to the extended position.    
     
     
         9 . The implantation device according to  claim 8 , wherein the seed transfer barrel is selectively rotatable along a longitudinal axis in order to move the seed chamber between the loading and firing positions.  
     
     
         10 . The implantation device according to  claim 9 , wherein the seed transfer barrel comprises a plurality of spaced apart, substantially parallel seed chambers, each seed chamber being selectively movable between the loading and firing positions in response to rotation of the seed transfer barrel.  
     
     
         11 . The implantation device according to  claim 10 , wherein the seed transfer barrel comprises a total of four seed chambers.  
     
     
         12 . The implantation device according to  claim 10 , further comprising: 
 a cam portion formed on the circumference of the seed transfer barrel; and    an advancing pin having at least one advancing tooth formed thereon, the advancing pin being selectively movable relative the transfer barrel to engage and disengage the advancing tooth from the cam portion, wherein the transfer barrel is rotatably driven by the advancing pin when the advancing tooth engages the cam portion.    
     
     
         13 . The implantation device according to  claim 12 , wherein a plurality of spaced apart cam portions are formed on the circumference of the seed transfer barrel.  
     
     
         14 . The implantation device according to  claim 13 , wherein the plurality of cam portions comprises a first cam portion formed on the circumference of the seed transfer barrel proximate a distal end of the transfer barrel and a second cam portion formed along the circumference of the seed transfer barrel proximate a proximal end of the transfer barrel, the first and second cam portions being spaced apart and offset from one another along the circumference of the transfer barrel, and the advancing pin having a proximal advancing tooth and a distal advancing tooth formed thereon, the proximal advancing tooth being spaced apart from the distal advancing tooth, wherein movement of the advancing pin in a first direction relative the transfer barrel causes the first advancing tooth to engage the first cam portion to rotatably drive the transfer barrel a first predetermined angular distance while the second advancing tooth is disengaged from the second cam portion, and wherein movement of the advancing pin in a second direction relative the transfer barrel causes the second advancing tooth to engage the second cam portion to rotatably drive the transfer barrel a second predetermined angular distance while the first advancing tooth is disengaged from the first cam portion.  
     
     
         15 . The implantation device according to  claim 14 , wherein a plurality of equally spaced, alternating first and second cam portions are formed along the circumference of the seed transfer barrel.  
     
     
         16 . The implantation device according to  claim 8 , further comprising a seed biasing member positioned within the seed alignment channel adapted to bias the seeds aligned within the seed alignment channel in a direction toward a seed chamber aligned with the seed alignment channel.  
     
     
         17 . The implantation device according to  claim 8 , wherein the elongated member further comprises an optical channel extending longitudinally through the elongated member for slidingly receiving the plunger, the optical channel being spaced apart and substantially parallel to the seed alignment channel and also being in aligned relation to and in communication with the bore through the needle.  
     
     
         18 . The implantation device according to  claim 8 , further comprising a seed lock located between the seed transfer barrel and the proximal end of the needle, the seed lock being in aligned relation to and communication with the bore of the needle and comprising a resilient spring-like member that is adapted to prevent a seed from passing from the seed chamber through the needle bore unless that seed is being driven by the plunger as the plunger moves from the retracted to the extended position.  
     
     
         19 . The implantation device according to  claim 6 , further comprising: 
 a housing located at a proximal end of the outer sheath; and    means for selectively moving the outer sheath in predetermined increments in the longitudinal direction relative the housing.    
     
     
         20 . The implantation device according to  claim 19 , wherein the means for selectively moving the outer sheath comprises a roticulator ring operably connecting the proximal end of the outer sheath to the housing.  
     
     
         21 . The implantation device according to  claim 20 , further comprising indicia formed on the roticulator ring to provide a visual indication of the selective movement of the outer sheath relative the housing.  
     
     
         22 . The implantation device according to  claim 19 , wherein the means for selectively moving the outer sheath comprises: 
 a control lever carried by the housing, the control lever having a plurality of gear teeth formed thereon for driving at least one gear rotatably mounted within the housing; and    a plurality of gear teeth formed on at least a portion of the outer sheath for interlocking engagement with the at least one gear, wherein rotation of the at least one gear in response to actuation of the control lever causes the outer sheath to move longitudinally relative the housing.    
     
     
         23 . The implantation device according to  claim 22 , further comprising indicia formed on the housing to provide a visual indication of the selective movement of the outer sheath relative the housing.  
     
     
         24 . The implantation device according to  claim 19 , further comprising means for selectively moving the plunger from the retracted position to the extended position.  
     
     
         25 . The implantation device according to  claim 24 , wherein the means for selectively moving the plunger comprises: 
 a second gear rotatably mounted within the housing, the second gear being driven in response to actuation of the control lever from a first angular position to a second angular position;    a plurality of gear teeth formed on at least a portion of the plunger for interlocking engagement with the second gear, wherein rotation of the second gear in response to actuation of the control lever causes the plunger to move longitudinally from the retracted position to the extended position.    
     
     
         26 . The implantation device according to  claim 25 , wherein actuation of the control lever from the second angular position to the first angular position causes the plunger to move longitudinally from the extended position to the retracted position.  
     
     
         27 . The implantation device according to  claim 14 , further comprising means for selectively moving the advancing pin in the first and second directions relative the seed transfer barrel in order to rotate the transfer barrel.  
     
     
         28 . The implantation device according to  claim 27 , wherein the means for selectively moving the advancing pin comprises: 
 a third gear rotatably mounted within a housing located at a proximal end of the implantation device, the third gear being driven in response to actuation of a control lever carried by the housing, the control lever having a plurality of gear teeth formed thereon for driving the third gear in response to actuation of the lever;    a rack having a first resilient hook projecting therefrom, the rack being slidably mounted within the housing and comprising a plurality of teeth for interlocking engagement with the third gear;    a hook member having a second resilient hook projecting therefrom, the hook member being slidably mounted within the housing; and    a linking shaft having a proximal end and a distal end, the distal end of the linking shaft being operatively connected to the advancing pin and the proximal end of the linking shaft being operatively connected to the hook member, wherein the rack is longitudinally driven relative the hook member in response to rotation of the third gear between a disengaged position where the first and second hooks are disengaged and an engaged position where the first and second hooks are releasably engaged.    
     
     
         29 . The implantation device according to  claim 3 , further comprising a seed counter indicator for providing a numerical visual indication of the number of seeds ejected from the implantation device through the needle.  
     
     
         30 . The implantation device according to  claim 8 , further comprising a removable seed cartridge adapted to hold a plurality of seeds for use with the implantation device, the seed cartridge having a proximal end and a distal end, the distal end being releasably connected to the implantation device for feeding the seeds into the seed alignment channel from the seed cartridge.  
     
     
         31 . The implantation device according to  claim 30 , wherein the seed cartridge comprises: 
 an elongated cylindrically-shaped core member having a seed conduit extending longitudinally therethrough, the seed conduit being in aligned relation to and communication with the seed alignment channel when the seed cartridge is releasably connected to the implantation device and the seed conduit being adapted to retain the plurality of seeds in end-to-end aligned relation prior to feeding the seeds into the seed alignment channel; and    an elongated seed advancement push rod slidably received within the seed conduit, wherein longitudinal movement of the push rod toward the distal end of the seed cartridge causes the seeds contained within the seed conduit to advance into the seed alignment channel from the seed cartridge.    
     
     
         32 . The implantation device according to  claim 31 , wherein the core member comprises a circumferential slot extending longitudinally throughout the length of the core member, the slot opening into the seed conduit; and wherein the push rod comprises a tab projecting therefrom that extends through the circumferential slot so that an operator of the implantation device may grip the tab to advance the push rod longitudinally through the seed conduit.  
     
     
         33 . The implantation device according to  claim 32 , further comprising an elongated, cylindrically-shaped outer sleeve having a bore extending therethrough for receiving the core member, the outer sleeve having a circumferential groove extending throughout the length of the outer sleeve and opening into the bore, wherein the push rod tab projects through the groove in the outer sleeve so that the operator of the implantation device may grip the tab to advance the push rod longitudinally through the seed conduit.  
     
     
         34 . The implantation device according to  claim 33 , wherein the circumferential groove formed in the outer sleeve is substantially parallel to the slot formed in the core member.  
     
     
         35 . The implantation device according to  claim 33 , wherein the outer sleeve is rotatable relative the core member and the circumferential groove formed in the outer sleeve is generally curved throughout the length of the outer sleeve so that the outer sleeve is caused to rotate relative the core member as the push rod tab is moved longitudinally through the outer sleeve groove and core member slot.  
     
     
         36 . The implantation device according to  claim 35 , wherein the outer sleeve is adapted to expose no more than one seed contained within the seed conduit through the outer sleeve groove and core member slot at any given time as the push rod tab is moved longitudinally through the outer sleeve groove and core member slot.  
     
     
         37 . The implantation device according to  claim 32 , wherein the core member includes a plurality of substantially parallel, spaced apart seed conduits extending longitudinally therethrough, each seed conduit being adapted to retain a plurality of seeds in end-to-end aligned relation prior to feeding the seeds into the seed alignment channel, the core member having a plurality of substantially parallel, spaced apart circumferential slots formed therein and extending longitudinally throughout the length of the core member, each slot opening into one of the seed conduits, and the seed cartridge adapted to be releasably connected to the implantation device so that any one of the seed conduits is in aligned relation to and communication with the seed alignment channel when the seed cartridge is releasably connected to the implantation device.  
     
     
         38 . The implantation device according to  claim 30 , wherein the seed cartridge comprises a locking key projecting from the distal end of the seed cartridge, the locking key being received within a keyhole formed within a housing of the implantation device to releasably connect the seed cartridge to the implantation device.  
     
     
         39 . The implantation device according to  claim 37 , wherein the seed cartridge comprises at least one locking key projecting from the distal end of the seed cartridge, the locking key being received within one of a plurality of keyholes formed within a housing of the implantation device to releasably connect the seed cartridge to the implantation device.  
     
     
         40 . The implantation device according to  claim 33 , further comprising an alignment adaptor comprising a proximal end and a distal end, the distal end being releasably connected to the implantation device and the proximal end being releasably connected to the outer sleeve, the alignment adaptor having a central bore extending therethrough so that, when the adaptor is connected to the implantation device and outer sleeve, the adaptor bore is in aligned relation to and communication with the seed alignment channel and a seed conduit extending through the core member.  
     
     
         41 . The implantation device according to  claim 40 , wherein at least one circumferential groove is formed on the proximal end of the alignment adaptor for releasably engaging an associated locking key formed on the outer sleeve and projecting into the outer sleeve bore when at least the proximal end of the alignment adaptor is received within the outer sleeve bore in order to releasably connect the seed cartridge to the implantation device.  
     
     
         42 . The implantation device according to  claim 41 , further comprising a plurality of spaced apart circumferential grooves formed on the proximal end of the alignment adaptor, each circumferential groove releasably engaging an associated locking key formed on the outer sleeve and projecting into the outer sleeve bore when at least the proximal end of the alignment adaptor is received within the outer sleeve bore in order to releasably connect the seed cartridge to the implantation device.  
     
     
         43 . The implantation device according to  claim 3 , wherein the implantation device is a single use device that is disposable after implantation of one or more seeds within the patient.  
     
     
         44 . The implantation device according to  claim 3 , wherein the implantation device is adapted to be sterilized for repeated use.  
     
     
         45 . A seed cartridge for holding a plurality of seeds for use with an implantation device of the type having a seed alignment channel, a hollow needle and a moveable plunger that causes seeds within the device to pass through the hollow needle and be implanted within or adjacent to a target area, such as a tumor, located within a patient, the seed cartridge comprising: 
 an elongated cylindrically-shaped core member having a seed conduit extending longitudinally therethrough, the seed conduit being adapted to retain the plurality of seeds in end-to-end aligned relation prior to feeding the seeds into the seed alignment channel of the implantation device;    locking means adapted to releasably connect the core member to the implantation device so that the seed conduit is in aligned relation to and communication with the seed alignment channel of the implantation device; and    an elongated seed advancement push rod slidably received within the seed conduit, the push rod being adapted to move longitudinally within the seed conduit to cause the seeds contained within the seed conduit to advance into the seed alignment channel of the implantation device from the seed cartridge.    
     
     
         46 . The seed cartridge according to  claim 45 , wherein the core member comprises a circumferential slot extending longitudinally throughout the length of the core member, the slot opening into the seed conduit; and wherein the push rod comprises a tab projecting therefrom that extends through the circumferential slot so that an operator of the implantation device may grip the tab to advance the push rod longitudinally through the seed conduit.  
     
     
         47 . The seed cartridge according to  claim 46 , further comprising an elongated, cylindrically-shaped outer sleeve having a bore extending therethrough for receiving the core member, the outer sleeve having a circumferential groove extending throughout the length of the outer sleeve and opening into the bore, wherein the push rod tab projects through the groove in the outer sleeve so that the operator of the implantation device may grip the tab to advance the push rod longitudinally through the seed conduit.  
     
     
         48 . The seed cartridge according to  claim 47 , wherein the circumferential groove formed in the outer sleeve is substantially parallel to the slot formed in the core member.  
     
     
         49 . The seed cartridge according to  claim 47 , wherein the outer sleeve is rotatable relative the core member and the circumferential groove formed in the outer sleeve is generally curved throughout the length of the outer sleeve so that the outer sleeve is caused to rotate relative the core member as the push rod tab is moved longitudinally through the outer sleeve groove and core member slot.  
     
     
         50 . The implantation device according to  claim 49 , wherein the outer sleeve is adapted to expose no more than one seed contained within the seed conduit through the outer sleeve groove and core member slot at any given time as the push rod tab is moved longitudinally through the outer sleeve groove and core member slot.  
     
     
         51 . The seed cartridge according to  claim 46 , further comprising: 
 a plurality of substantially parallel, spaced apart seed conduits extending longitudinally through the core member, each seed conduit being adapted to retain a plurality of seeds in end-to-end aligned relation prior to feeding the seeds into the seed alignment channel; and    a plurality of substantially parallel, spaced apart circumferential slots formed on and extending longitudinally throughout the length of the core member, each slot opening into one of the seed conduits; wherein the locking means is adapted to releasably connect the core member to the implantation device so that any one of the seed conduits is in aligned relation to and communication with the seed alignment channel when the core member is releasably connected to the implantation device.    
     
     
         52 . The seed cartridge according to  claim 47 , wherein the locking means is formed on an end of the outer sleeve.  
     
     
         53 . The seed cartridge according to  claim 45 , wherein the locking means comprises a locking key projecting from an end of the seed cartridge, the locking key adapted to be received within a keyhole formed within a housing of the implantation device to releasably connect the seed cartridge to the implantation device.  
     
     
         54 . The seed cartridge according to  claim 51 , wherein the locking means comprises at least one locking key projecting from an end of the seed cartridge, the locking key being adapted to be received within one of a plurality of keyholes formed within a housing of the implantation device to releasably connect the seed cartridge to the implantation device.  
     
     
         55 . The seed cartridge according to  claim 47 , further comprising an alignment adaptor having a proximal end and a distal end, the distal end being adapted to be releasably connected to the implantation device and the proximal end being releasably connected to the outer sleeve, the alignment adaptor having a central bore extending therethrough so that, when the adaptor is connected to the implantation device and outer sleeve, the adaptor bore is in aligned relation to and communication with the seed alignment channel in the implantation device and a seed conduit extending through the core member.  
     
     
         56 . The seed cartridge according to  claim 55 , wherein at least one circumferential groove is formed on the proximal end of the alignment adaptor for releasably engaging an associated locking key formed on the outer sleeve and projecting into the outer sleeve bore when at least the proximal end of the alignment adaptor is received within the outer sleeve bore in order to releasably connect the seed cartridge to the implantation device.  
     
     
         57 . The seed cartridge according to  claim 55 , further comprising a plurality of spaced apart circumferential grooves formed on the proximal end of the alignment adaptor, each circumferential groove releasably engaging an associated locking key formed on the outer sleeve and projecting into the outer sleeve bore when at least the proximal end of the alignment adaptor is received within the outer sleeve bore in order to releasably connect the seed cartridge to the implantation device.  
     
     
         58 . The seed cartridge according to  claim 49 , further comprising: 
 a proximal end cap releasably secured to a proximal end of the outer core, the proximal end cap having at least one cut-out section to facilitate introduction of the push rod into the seed conduit and the push rod tab within the circumferential slot and groove of the core member and outer sleeve, respectively; and    a distal end cap releasably secured to a distal end of the inner core, the distal end cap having a plurality of apertures formed therein, each aperture being in aligned relationship and communication with one of the seed conduits.    
     
     
         59 . The seed cartridge according to  claim 58 , further comprising first and second foils for sealing the seed cartridge prior to use with the implantation device, the first foil located between the distal end cap and the core member and the second foil located between the proximal end cap and the outer sleeve, wherein the first and second foils may be penetrated by the push rod as the push rod is advance through the seed cartridge.  
     
     
         60 . A method for loading and discharging a plurality of seeds from an implantation device, comprising the steps of: 
 loading the seeds into the implantation device;    selectively positioning one of the seeds in aligned relation to and communication with a bore through a hollow implantation needle operatively connected to the device;    selectively moving an elongated plunger from a retracted position spaced apart from the needle to an extended position to advance the aligned seed through the needle bore and out of the needle; and    viewing the aligned seed prior to advancement through the needle and following discharge of the aligned seed out of the needle using an a optical device carried by the implantation device to provide visual assistance to the operator of the implantation device to guide and verify implantation of the discharged seed into a target area of a patient.    
     
     
         61 . The method according to  claim 60 , wherein the optical device is operatively connected to and carried by the plunger so that when the plunger is selectively moved to the extended position, the optical device is carried by the plunger through the needle bore to a position proximate the distal end of the needle.  
     
     
         62 . The method according to  claim 61 , wherein the optical device is a fiberoptic scope.  
     
     
         63 . The method according to  claim 61 , wherein the optical device is an optical scope.  
     
     
         64 . The method according to  claim 61 , further comprising the step of selectively moving an elongated outer sheath in predetermined increments relative the needle to position the needle at the desired target area.  
     
     
         65 . The method according to  claim 64 , further comprising the steps of: 
 receiving the seeds in aligned relation within a seed alignment channel: 
 inserting one of the seeds located within the seed alignment channel into a selectively movable seed chamber in aligned relation to and communication with the seed alignment channel; and  
 selectively advancing the seed channel containing the inserted seed to a firing position in aligned relation to and communication with the needle bore.  
   
     
     
         66 . The method according to  claim 65 , further comprising the step of selectively moving the elongated plunger from the extended position to the retracted position prior to selectively advancing the seed channel.  
     
     
         67 . The method according to  claim 65 , wherein the step of selectively advancing the seed channel comprises the steps of: 
 selectively moving a first advancing pin tooth in a first direction into engagement with a first circumferential cam portion formed on a seed transfer barrel in which the seed channel is formed to rotate the seed channel a first predetermined angular distance; and    selectively moving a second advancing pin tooth in a second direction into engagement with a second circumferential cam portion formed on the seed transfer barrel to rotate the seed channel a second predetermined angular distance.    
     
     
         68 . The method according to  claim 65 , further comprising the step of biasing the seeds aligned within the seed alignment channel toward the seed chamber.  
     
     
         69 . The method according to  claim 61 , further comprising the step of preventing the positioned seed from passing through the needle bore unless that positioned seed is being driven by the plunger as the plunger is selectively moved from the retracted position to the extended position.  
     
     
         70 . The method according to  claim 66 , wherein the step of selectively moving the plunger from the retracted position to the extended position comprises the step of actuating a control lever having a first set of gear teeth formed thereon from a first position to a second position in order to drive a second set of gear teeth formed on a portion of the plunger.  
     
     
         71 . The method according to claim  70 , wherein the step of selectively moving the outer sheath comprises the step of actuating the control lever having a first set of gear teeth formed thereon from the second position to a third position to drive a third set of gear teeth formed on a portion of the outer sheath.  
     
     
         72 . The method according to claim  71 , wherein the step of selectively advancing the seed channel comprises the step of actuating the control lever from the third position back to the first position.  
     
     
         73 . The method according to claim  71 , wherein the step of selectively moving the plunger from the extended position to the retracted position comprises the step of actuating the control lever from the third position back to the first position.  
     
     
         74 . The method according to  claim 61 , further comprising the step of providing a visual indication of the number of seeds ejected from the implantation device through the needle.  
     
     
         75 . The method according to  claim 65 , wherein the step of loading the seeds into the implantation device comprises the step of: 
 placing a plurality of seeds within a seed conduit formed within a cartridge;    releasably connecting the seed cartridge to the implantation device so that the seed conduit is in aligned relation and communication with the seed alignment channel; and    advancing the seeds within the seed conduit out of the seed cartridge and into the seed alignment channel of the implantation device.    
     
     
         76 . The method according to claim  75 , wherein the step of advancing the seed within the seed conduit comprises the step of inserting a push rod into the seed conduit to force the seeds contained therein out of the seed cartridge and into the seed alignment channel of the implantation device.