Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-12-29
2001-08-07
Kennedy, Sharon (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S060000, C600S007000
Reexamination Certificate
active
06270472
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to apparatus and a method for introducing implants such as radioactive seeds, or pellets or dissolvable capsules carrying medication or transgenes, into soft tissue such as tumors, and particularly intra-abdominal or intrathoracic tumors. Specifically, it relates to such an apparatus and method which deposits multiple implants in soft tissue with precise, selectable spacing between implants.
2. Background Information
It is known to inject radioactive seeds into the prostate to treat malignancies. Early devices for this purpose injected a single seed using a hollow needle from which the seed was ejected by a plunger. Later devices have the capability of introducing multiple seeds. Some deposit a single elongated implant having multiple seeds distributed longitudinally. Others have a plunger with multiple, axially spaced seed cavities inserted through a cannula with equally spaced side openings for laterally discharging the seeds. Neither of these approaches offer flexibility in the spacing between multiple implants. Furthermore, there is difficulty in laterally discharging the implants in the second arrangement. It has been proposed to incorporate small leaf springs in the cavities to push the implants clear of the cannula, but withdrawing the cannula past the seeds disturbs their positions and the diameter of the cannula must be enlarged to accommodate the springs. Still other multiple seed ejectors rely upon the user to set the spacing between seeds. The accuracy of this technique is dependent upon the skill of the user or requires fluoroscopy to monitor seed location.
There is a need for an improved apparatus for introducing implants into soft tissue.
There is a particular need for an improved apparatus for introducing multiple implants at precisely spaced locations within the soft tissue.
There is a related need for such apparatus with which the spacing between implants can be easily and accurately adjusted.
There is also a need for such apparatus which can be used to introduce implants into soft tissue within a cavity such as intra-abdominal and intrathoracic tumors.
There is an additional need for such apparatus which can be easily loaded and simple to use, and particularly which only requires one hand of the user to deposit the implants with precise spacing.
There is a further need for such a device which can be used for various types of implants, such as radioactive seeds, or pellets bearing or dissolvable capsules containing medications or transgenes.
SUMMARY OF THE INVENTION
These needs and others are satisfied by the invention which is directed to apparatus and a method for introducing implants into soft tissue at spaced intervals.
The apparatus includes an introducer in the form of an elongated tube having a distal end which is insertable into the soft tissue and within which a plurality of implants are retained. An obturator is slidable within the introducer from the proximal end. The apparatus further includes a sleeve through which the introducer slidably extends. An operating means incrementally withdraws the introducer rearward relative to the sleeve a distance L. Initially, the obturator remains stationary while the introducer is withdrawn so that an implant is pushed out of the end of the introducer. After the introducer has been withdrawn a distance L
s
equal to the length of one implant, automatic coupling means of the operating mechanism couples the obturator to the introducer so that both the obturator and the introducer are withdrawn the remainder of the distance L. This distance L
p
that the obturator and introducer are withdrawn together provides spacing between the implants. Thus, the implants are deposited within the soft tissue with precise spacing in between. In accordance with one aspect of the invention, this spacing L
p
is adjustable.
The implants which are deposited by the apparatus of the invention can be radioactive seeds. They can also be dissolvable capsules containing medication or transgenes. The implants can also be resorbable pellets carrying medication or transgenes. The invention is particularly suitable for depositing implants in intra-abdominal and intrathoracic tumors. In such case, the sleeve of the apparatus can have a tubular extension which is inserted through an incision in the external wall defining the cavity in which the tumor is located. The tubular extension can be positioned for inserting the introducer into the tumor by a laparoscope or thoracoscope inserted through another small incision as is known. This eliminates the need to use a fluoroscope or an open incision to align the apparatus with a tumor. With the tubular extension on the sleeve properly aligned relative to the tumor, the introducer is extended through the tubular extension into the tumor. To this end, the introducer is provided with a sharpened end.
Several lines of spaced implants can be deposited within the tumor using the invention. After each line of implants has been deposited, the tubular extension is repositioned such as by using the laparoscope or thoracoscope and the procedure is repeated. As used throughout, the term “forward” will be used in reference to movement toward or into the soft tissue and the term “rearward” in reference to movement away from or out of the soft tissue.
The preferred embodiment of the invention is particularly suited for depositing multiple lines of implants in soft tissue. In this embodiment, the introducer has an enlarged proximal end in the form of a tubular member which is received in the sleeve. The means incrementally withdrawing the introducer comprises a trigger mechanism including a trigger supported on the tubular member. A slide is slidable forward relative to the tubular member upon actuation of the trigger. A one-way clutch locks the slide to the sleeve as the trigger is actuated so that, in effect, the slide remains stationary relative to the sleeve and the tubular member is incrementally withdrawn rearward the distance L with respect to the sleeve each time the trigger is actuated. The means automatically coupling the obturator to the introducer is a holding device engaged by the slide which holds the obturator stationary relative to the sleeve until the introducer has been withdrawn the distance L
s
. A slip clutch through which the obturator slips as the introducer moves the distance L
s
couples the obturator to the introducer for movement with the introducer over the distance L
p
.
Preferably, the one-way clutch which locks the slide to the sleeve includes a rack and a pawl member, with the rack provided on the slide and the pawl member mounted on the sleeve. A spring biases the slide rearward upon release of the trigger. Means such as an O-ring resist forward movement of the tubular member relative to the sleeve in response to this bias. As the slide moves rearward, the pawl member slides over the rack teeth and the apparatus is ready for deposit of another implant by reactuation of the trigger. Each time the trigger is actuated, the tubular member, and therefore the introducer, moves incrementally rearward to deposit an implant and provide the spacing L
p
. When the desired number of implants have been deposited in a row, the pawl member is lifted, and the tubular member/introducer is slid forward relative to the sleeve to reset the introducer for laying down another row of implants.
In the preferred embodiment of the invention, the means holding the obturator stationary relative to the sleeve while the implant is deposited comprises a fore shuttle slidable in the tubular member, and a directional clutch blocking rearward movement of the obturator relative to the fore shuttle. This holding device further includes a decoupling spring between the slide and the fore shuttle holding the fore shuttle stationary relative to the sleeve while the introducer moves the distance L
s
relative to the sleeve until the fore shuttle seats relative to the tubular member and is then carried rearward with the tubular member against the d
Antaki James F.
Greenberger Joel S.
Holmes John A.
Schauer Philip
Eckert Seamans Cherin & Mellott , LLC
Kennedy Sharon
University of Pittsburgh of the Commonwealth System of Higher Ed
Westerhoff Richard V.
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