Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-12-22
2001-02-20
Bockelman, Mark (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06190350
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to an implanter device and method. More particularly, the invention relates to a hand held implanter for containing and depositing a subcutaneous implant beneath the skin of a patient.
BACKGROUND OF THE INVENTION
Many different types of delivery systems for delivering beneficial agents such as pharmaceuticals for the prevention, treatment, and diagnosis of disease are known in the art. One type of delivery system is the subcutaneous implant which contains a supply of a beneficial agent and is implanted beneath the skin of a patient to deliver the beneficial agent over time. Some of the different types of subcutaneous implants include osmotic drug delivery implants, dissolvable or erodable pellet type implants, and diffusional implants. Some examples of osmotic delivery implant systems are described in U.S. Pat. Nos. 4,111,202; 4,111,203; and 4,203,439.
The process of placing subcutaneous osmotic implants and other types of implants under the skin has previously been performed by use of a trocar system which is a two piece system including a cannula and an obturator. With this system, an incision is first made through the skin and the cannula and obturator are inserted together through the skin. The obturator is then withdrawn leaving the cannula in place as a guide for inserting the implant. The implant is inserted through the cannula while the obturator is used to push the implant to the end of the cannula. The obturator is then used to force the implant out of the cannula while the cannula is withdrawn to deposit the implant in the channel previously occupied by the cannula. The cannula and obturator are then withdrawn completely leaving the implant in place beneath the skin.
This trocar insertion process requires substantial expertise in coordinating the pressing of the obturator and the withdrawing of the cannula to deposit the implant in the channel. If these two processes are not properly coordinated, the implant may be forced into the tissue so that the implant has to make its own channel as it is inserted. Forcing the implant into the tissue causes additional trauma to the tissue and may cause the implant to become damaged by the force exerted by the obturator.
This method of insertion of an implant with a trocar is relatively time consuming and cumbersome. In addition, with this prior art insertion method the removal of the obturator for insertion of the implant through the cannula and the reinsertion of the obturator increase the possibility that sterility of the implant site will be compromised during this process.
An implanting apparatus for use in subcutaneously implanting multiple pellets in animals, disclosed in U.S. Pat. No. 4,105,030, provides a one-handed implanting system which reduces the risk of trauma to the tissue due to forcing the implant into the tissue and reduces contamination. The animal implant apparatus includes a handle, a needle containing the pellets to be implanted, and a rod positioned within the needle for pushing the pellets out of the needle. Once the needle containing the pellets has been inserted subcutaneously, a spring loaded trigger on the handle is activated which causes the needle to be automatically withdrawn by a spring leaving the implanted pellets in place. However, the handle configuration of this implanting device is designed for use in animals, such as cattle, and due to it's size and shape would be difficult to use for inserting implants subcutaneously in humans. Further, it is not possible to control the motion of the needle in this device because the needle will automatically retract upon activation of the trigger. The complex spring loaded propelling system and trigger of this implant apparatus increase the chances that the device will jam and fail to eject the pellets when required.
Accordingly, it would be desirable to provide a device for insertion of subcutaneous implants which would simplify the insertion process, allow one handed implant insertion, provide better control over the insertion process, and improve reliability by avoiding implanter jams.
OBJECTS AND SUMMARY OF THE INVENTION
The implanter according to a preferred embodiment of the present invention addresses the disadvantages of the known implant insertion methods by providing a one piece, hand held implanter which is not susceptible to becoming jammed due to binding of moving parts, and allows better control of the implant insertion process than spring actuated implanters.
According to one aspect of the present invention, an implanter for inserting implants includes a handle for grasping the implanter during insertion of an implant, a rod longitudinally fixed to the handle, and a hollow cannula position coaxially around and longitudinally slidable over the rod. The hollow cannula is movable from an extended position in which an implant is retained in the cannula to a retracted position in which the implant is released from the cannula. An actuator is connected to the cannula and slidable in the track of the handle to move the cannula from the extended position to the retracted position.
According to a further aspect of the present invention, a subcutaneous implant insertion system includes an implanter and a subcutaneous implant contained within a cannula of the implanter. The implanter includes a handle, a rod longitudinally fixed within the handle, a hollow cannula longitudinally slidable on the rod, and an actuator connected to the cannula and longitudinally slidable in the handle to move the cannula from an extended position to a retracted position to release the implant from the cannula.
According to a further aspect of the present invention, a method of inserting a subcutaneous implant with an implanter includes inserting a cannula of an implanter beneath the skin of a patient with an implant positioned within the cannula, manually retracting the cannula to release the implant beneath the skin, and withdrawing the implanter from the patient. The implanter used in the method includes a handle and an actuator attached to the cannula such that by sliding the actuator along a track in the handle, the implant is released.
In accordance with another aspect of the present invention, an implant inserting system includes a vial, an elongated implant secured within the vial, and an implanter. The vial has an opening and a closure for closing the opening. The implant is secured within the vial with a longitudinal axis of the implant aligned with the opening of the vial. The implanter has a handle and an elongated cannula extending from the handle for receiving the implant from the vial. The cannula is configured to be inserted into the vial through the opening to remove the implant from the vial.
According to a further aspect of the present invention, an implant vial includes an implant containing a beneficial agent to be delivered, a vial body having an open end, and an implant holding member positioned within the vial body for retaining a position of the implant within the vial. A tapered mouth positioned in the open end of the vial directs a cannula inserted into the open end of the vial body around the implant. A stopper having a sealing surface is arranged to seal a dispensing opening of the implant to prevent the beneficial agent from leaking from the implant. The stopper also seals the open end of the vial body.
According to another further aspect of the present invention, a kit for inserting an implant and maintaining sterile conditions includes an implanter including a handle, a rod longitudinally fixed within the handle, a hollow cannula longitudinally slidable on the rod, and an actuator connected to the cannula and longitudinally slidable in the handle to move the cannula from an extended position to a retracted position to release the implant from the cannula; a cutting device for making an implanting incision in tissue; supplies for maintaining sterility of the implant insertion process; and wound dressings.
It is an object of the present invention to provide a single device insertion system fo
Davis Craig R.
Peery John R.
ALZA Corporation
Bockelman Mark
Clarke Pauline A.
Lynch Cindy A.
Stone Steven F.
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