Tethered and/or visually coded brachytherapy devices and related methods

Abstract

Brachytherapy devices include a respective flexible elongate tether with an external free tail end that has an opposing end that is attached to a proximal end portion of the corresponding strand. The tethers can be color-coded to match a color associated with the corresponding strand and/or radioactive material to facilitate visual correspondence for redeployment when a strand is in an undesired implanted location. Grids with color-coded rows may also be used to facilitate surgical placement and/or identification of respective strand/tether pairs.

1 . (canceled) 
     
     
         2 . A brachytherapy device, comprising:
 a needle;   an implantable strand with radioactive material held by the needle for implantation; and   a flexible tether attached to a proximal end portion of the strand that has a length that is sufficient to extend outside a patient body as an external tail thereof when the strand is implanted in the patient, wherein the flexible tether comprises visual indicia on the external tail that corresponds to visual indicia associated with the strand and/or radioactive material of the strand to visually identify that the tether and strand are attached to thereby facilitate visual recognition of the strand associated with an external tether tail when the strand is implanted in a patient.   
     
     
         3 . The device of  claim 2 , wherein, when the strand is implanted in the patient, the external tail is an external free end, and wherein the tether and strand are color coded to provide the visual indicia. 
     
     
         4 . The device of  claim 2 , wherein the visual indicia of the tether and strand comprises color so that at least a distal end of the strand has the visual indicia color that corresponds to the visual indicia color on the tail of the flexible tether, and wherein the visual indicia color of a respective strand and tether pair is also associated with a corresponding color in a row or column of a brachytherapy template grid having a plurality of different defined colors for respective rows and/or columns with a series of ports to allow a visual recognition of an improperly placed strand based on correlation of a grid location having a color corresponding to the visual indicia color of the tether and strand pair. 
     
     
         5 . The device of  claim 2 , wherein the tether extends beyond the needle in a direction away from the strand a distance between 1-12 inches, and wherein the external tail and the strand are color-coded to provide the visual indicia. 
     
     
         6 . The device of  claim 2 , wherein the length of the tether is between about 100-500 mm, and wherein, in position when the strand is implanted in the patient, the external tail is an external free end, and wherein the tether and strand are color-coded to provide the visual indicia. 
     
     
         7 . The device of  claim 2 , in combination with between 10-60 of the brachytherapy devices, wherein respective pairs of tethers and strands of the 10-60 brachytherapy devices all having different colors, with each pair of tether and strand being color-coded to each other to provide the visual indicia. 
     
     
         8 . The combination of  claim 7 , wherein the radioactive material of the strands comprises radioactive seeds, and wherein at least a distal seed of the different strands comprise a different color from the other strands, the color corresponding to a color of the respective color-coded strand and tether pair, and wherein the different colors are used for tether and strand pairs having a common radioactive material. 
     
     
         9 . A set of brachytherapy assemblies, comprising between 10-60 brachytherapy assemblies, each assembly comprising:
 a needle, wherein the needle comprises a needle handle at a proximal portion thereof;   a strand with radioactive material residing in a distal end portion of the needle, the strand comprising a flexible tether that has a length sufficient to provide an external tail that resides external of a patient when the strand is implanted, wherein the tether and the strand and/or radioactive material of the strand comprises corresponding visual indicia, and wherein the between 10-60 brachytherapy assemblies each comprise different corresponding visual indicia and a common radioactive material;   a plunger residing in the needle configured to slidably hold the tether, wherein the plunger comprises a plunger handle at a proximal portion thereof; and   a deployment guard that releasably resides between the needle handle and the plunger handle prior to active deployment,   wherein, in operation, the plunger handle slides the plunger a distance into the needle to force the strand with the radioactive material to exit the needle into target tissue, and wherein the external tail of the tether extends externally away from the assembly between the needle handle and the plunger handle when the deployment guard is in position.   
     
     
         10 . The set of  claim 9 , wherein the tether and the strand are color-coded to provide corresponding visual indicia. 
     
     
         11 . The set of  claim 10 , wherein the strand radioactive material comprises a plurality of spaced apart radioactive seeds, and wherein the tether and at least a distal seed are color-coded. 
     
     
         12 . The set of  claim 9 , wherein the plunger comprises a longitudinally extending bore and/or slot that receives the tether therein. 
     
     
         13 . The set of  claim 9 , wherein the tether has a length sufficient to extend inside the needle to exit at a proximal portion of the needle and extend a distance beyond the needle in a direction away from the strand a distance between 1-12 inches, and wherein the external tail and the strand are color-coded to provide the visual indicia. 
     
     
         14 . The set of  claim 9 , wherein the tether resides in a center bore of the plunger inside the needle and exits the plunger and needle at a location that is proximate a handle associated with the needle. 
     
     
         15 . The set of  claim 9 , wherein the deployment guard comprises a pair of arms that define a longitudinally extending channel that releasably holds a stem of the plunger. 
     
     
         16 . The set of  claim 9 , wherein the tether and strand of each brachytherapy assembly are color-coded to provide the corresponding visual indicia, with each of the between 10-60 brachytherapy assemblies having different colors for the color-coded visual indicia, and wherein at least one of the plunger handle or needle handle is also color-coded to a respective strand and tether pair. 
     
     
         17 . A set of brachytherapy strands comprising:
 a plurality of strand and flexible tether pairs for a respective single patient therapy, wherein a respective strand of the strand and flexible tether pairs comprises radioactive material and is implantable, wherein a flexible tether of a respective flexible tether of the strand and flexible tether pairs has a length sufficient to define an external tail that is external of a patient's body when a corresponding strand of radioactive material of the strand and flexible tether pair is implanted, and wherein the external tails comprise different colors from each other, and wherein each strand and tether pair can be slidably independently repositioned and/or withdrawn.   
     
     
         18 . The set of  claim 17 , wherein each strand and flexible tether pair is color-coded to each other, and wherein different tether and strand pairs have different color-coding. 
     
     
         19 . The set of  claim 17 , wherein the radioactive material comprises a plurality of spaced apart seeds, and wherein each strand comprises a color on a distal radioactive seed that is color-coded to a color of a respective flexible tether. 
     
     
         20 . The set of  claim 17 , further comprising a plurality of elongate needles, each needle holding a corresponding strand of a strand and a flexible tether pair so that the external tail extends a distance out of the needle away from the strand, wherein the plurality of pairs is between 10-60, each external tail comprising a different color and a common radioactive material. 
     
     
         21 . A brachytherapy template grid, comprising:
 a grid body with a set of channels with intrabody entry ports arranged in defined columns and rows, wherein at least one of the rows is configured to have different color indicia than other rows.   
     
     
         22 . The grid of  claim 21 , wherein at least six rows of the grid body each have color indicia that is different from each other, and the defined columns and rows comprise unique alphanumeric indicia that correspond to specific channel locations. 
     
     
         23 . A method of carrying out a brachytherapy procedure, comprising:
 providing a plurality of needles comprising strands of radioactive material attached to a flexible tether, wherein different stands have different colors and different flexible tethers have different colors and pairs of the strands and flexible tethers are color-coded to each other, the needles comprising a plunger;   slidably extending the plungers in the needles to implant the strands of radioactive material into a patient while the associated tethers remain attached so that the tethers extend through a respective needle to exit a proximal portion thereof with a length sufficient to extend outwardly away from the needle to provide external tails of the tethers with different colors; and   visually identifying a color on an implanted strand of radioactive material and/or on the radioactive material that is in an undesired location in the body;   visually identifying what external tail has the identified color; and   pulling the tether with the identified color from the undesired location in the body of the patient.   
     
     
         24 . The method of  claim 23 , further comprising, before the slidably extending, aligning the needles with a grid having an array of grid channels, with channels and/or rows of channels having the different colors and inserting the needle having a corresponding color strand and/or tether into the channel and/or row having the same color. 
     
     
         25 . The method of  claim 23 , further comprising aligning the needles with a grid having an array of grid channels, with channels and/or rows of channels having a color corresponding to at least one of the different colors, inserting respect needle with the strand and tether into a channel of the grid having a corresponding color, and wherein the inserting is repeated a plurality of times to insert different color strands with tethers into channels in rows with corresponding colors. 
     
     
         26 . The method of  claim 23 , further comprising slidably extending the tethers through a respective slot or bore in a respective plunger a distance substantially equal to a distance the radioactive strand travels during the extendings tep. 
     
     
         27 . The method of  claim 23 , wherein the providing step is carried out by providing between 10-60 needles, each with different colors of strands and tethers. 
     
     
         28 . A method of fabricating brachytherapy strands, comprising:
 providing a strand of radioactive material with a flexible tether that has a length with an external free end that extends outside a body of a patient when the radioactive material is in an implanted position;   placing color indicia on the tether that corresponds to color indicia on the strand, wherein the tether color indicia corresponds to color indicia of the strand of the radioactive material; and   repeating the providing and placing steps using different color indicia for different tether and strand pairs having a common radioactive material.   
     
     
         29 . The method of  claim 28 , further comprising repeating the providing and placing steps to provide a set of between 10-60 brachytherapy strands and tether pairs for a single patient therapy with different color indicia. 
     
     
         30 . The method of  claim 28 , wherein tether has a length that is between about 100-500 mm.