Surgery – Radioactive substance applied to body for therapy – Radioactive substance placed within body
Reexamination Certificate
2003-03-24
2004-04-27
Winakur, Eric F. (Department: 3736)
Surgery
Radioactive substance applied to body for therapy
Radioactive substance placed within body
Reexamination Certificate
active
06726617
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates, generally, to a surgical tool for implanting radioactive seeds into a prostate gland or other internal organ. More particularly, it relates to a tool having disposable parts.
2. Description of the Prior Art
Radioactive seeds are implanted into a cancerous prostate gland to kill the tumor or tumors therein. Such seeds may also be used to attack tumors in other internal organs of the body.
In use, an applicator comes into contact with a patient's blood and other body fluids. Earlier applicators were therefore designed to be disposed of after use.
For example, U.S. Pat. No. 6,213,932 to the present inventor discloses a disposable applicator having the general appearance of a hypodermic syringe. It includes a transparent plastic cartridge for holding a plurality of radioactive tumor-killing seeds. Since the entire device is disposable after use, materials used in its construction must be re-cycled to avoid wasting such materials.
Pending U.S. patent application Ser. No. 09/829,190, now U.S. Pat. No. 6,561,967 also to the present inventor, improves upon the patented tool by providing an applicator having a plurality of cartridges that are stored on the body of the applicator so that a new cartridge is easily retrieved when all of the seeds have been discharged from an old cartridge. That patent application is incorporated herein by reference. The applicator of the pending patent application includes a disposable section from the needle to where the seeds are deployed from the cartridge. This represents an improvement over the earlier device because the entire applicator need not be discarded after use.
However, the patent pending applicator is not easily disassembled for cleaning.
It would therefore be advantageous if an applicator were provided that could be easily disassembled for cleaning. It would be even more advantageous if only the parts of an applicator that directly contact body fluids would be disposable while the rest of the applicator could be taken apart and cleaned easily for re-use.
Another drawback of earlier devices is that complete shielding of the cartridges precludes visual inspection of the seeds therewithin. A physician using an applicator would prefer to visually inspect the cartridges to see how many are remaining in a cartridge at any given time. If the cartridge is shielded (offers radiation protection), it is no longer transparent.
However, in view of the prior art considered as a whole at the time the present invention was made, it was not obvious to those of ordinary skill in the pertinent art how such need could be fulfilled.
SUMMARY OF THE INVENTION
The long-standing but heretofore unfulfilled need for an improved cartridge and applicator for implanting radioactive seeds in internal organs is now met by a new, useful, and nonobvious invention. The invention includes a disposable internal part that comes into contact with a patient's blood and other body fluids. The disposable inner part is made of two elongate half parts and each half part has a longitudinally-extending groove formed therein. Moreover, each of the half parts has half of a cartridge housing formed therein as well. An elongate throughbore is formed by joining together the two half parts. Specifically, the elongate throughbore is formed by juxtaposition of the longitudinally-extending grooves.
A cartridge housing is also formed by joining together the two half parts. More particularly, the cartridge housing is formed by juxtaposition of the halves of the cartridge housing formed in said halves of said disposable inner part.
The elongate throughbore is discontinuous at the cartridge housing and has a trailing part on a trailing side of the cartridge housing and a leading part on a leading side of the cartridge housing.
The novel applicator further includes a polyimide transition tube having a trailing end captured by the leading part of the elongate throughbore. The transition tube has a leading end that extends from the elongate throughbore in leading relation thereto and the transition tube leading end is adapted to be positioned within a lumen of an elongate needle that has a sharp distal end for penetrating tissue.
The novel applicator outer shell is formed by two half shells. Each of the two outer half shells has a longitudinally-extending half-channel formed therein. An elongate channel is formed by joining together the two half shells in juxtaposition with one another.
A cartridge housing-receiving recess is formed in each of the half shells. Each half channel is discontinuous at the cartridge housing-receiving recess. The disposable inner part, including the cartridge housing, is disposed in sandwiched relation between the half shells when the half shells are in juxtaposition with one another.
A longitudinally-extending groove is formed in an external side wall of each of the half shells. A slide member has a generally “U”-shaped configuration that includes a pair of upstanding side walls projecting from a base wall in parallel relation to one another. A longitudinally-extending tongue is formed in each side wall of the pair of side walls. The longitudinally-extending tongues protrude toward one another so that the longitudinally-extending tongues respectively slideably engage the longitudinally-extending grooves formed in the exterior side walls of the applicator half shells.
The applicator half shells are held in juxtaposition to one another by the slide member to form the applicator shell. Removal of the slide member from the applicator half shells enables cleaning of the slide member and the applicator half shells.
An elongate rod is secured to and projects from the slide member in leading relation thereto. A “U”-shaped support member is secured to a leading end of the elongate rod.
A transversely disposed handle is secured to a trailing end of a preselected applicator half shell. The transversely disposed handle is centered with respect to the applicator shell when the applicator half shells are joined together.
The novel seed cartridge for holding radioactive seeds includes a seed housing adapted to hold a plurality of radioactive seeds. The seed housing includes a shielded front plate and a shielded door is formed in the front plate. The shielded door is adapted to be opened and closed so that seeds within the seed housing may be viewed when the shielded door is open and so that the seeds within the seed housing may not be viewed when the shielded door is closed. The shielded door and shielded front plate protect an ambient environment from radiation when the door is closed.
More particularly, a vertically extending opening is formed in the front plate and a vertically extending tongue is formed in opposite vertically extending edges of the vertically extending opening. A vertically extending groove is formed in each vertically extending edge of the shielded door and a door handle is secured to the shielded door so that a user may slide the door in the opening in a first direction to view seeds disposed in the housing and so that a user may slide the door in the opening in a second direction to close the door.
In a second embodiment of the invention, the disposable internal parts are integrally formed with one another.
In a third embodiment of the invention, the disposable internal parts are integrally formed with the two applicator half shells.
An important object of this invention is to provide an applicator having disposable internal parts that directly contact a patient's blood and other body fluids.
Another important object is to provide an applicator that is easily disassembled so that the internal parts requiring disposal are easily separated from the rest of the applicator for such disposal.
Still another object is to provide an applicator where the parts thereof that do not require disposal are easily assembled and disassembled and easily cleaned for re-use.
Yet another object is to provide a cartridge having a sliding door so that a physician may slide the door open to vi
Miller Stanley M.
Veniaminov Nikita R
Winakur Eric F.
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