Surgery – Instruments
Reexamination Certificate
2000-09-14
2002-03-19
Fidei, David T. (Department: 3728)
Surgery
Instruments
C606S045000, C206S365000
Reexamination Certificate
active
06358241
ABSTRACT:
BACKGROUND OF THE INVENTION
This invention relates to packages for surgical devices, and particularly to packages for removable tips of such devices.
Examples of surgical devices with removable tips include electrosurgical devices, such as monopolar cauterization devices and diathermy devices. Other types of removable tips are sharp tips (e.g., needles, pics, and blades) that are attached to the end of a handle.
SUMMARY OF THE INVENTION
This invention features a package for a surgical device tip which may be used for insertion of the tip onto and removal of the tip from the handle of the surgical device, without requiring any direct contact between the user's hand and the tip.
In one general aspect of the invention, a package for a tip of a surgical device capable of removable attachment to an end of a handle includes a housing having a tip cavity shaped to receive the tip and an opening through which the end of the handle is insertable for removable attachment to the tip. Related aspects of the invention feature the combination of the package and a tip disposed in the package, and methods of using the package to attach the tip onto, and detach the tip from, the handle.
Preferred embodiments may include one or more of the following features.
A releasable locking mechanism, which is released in response to the end of the handle being disposed in the opening for removable attachment to the tip, retains the tip in the tip cavity. The releasable locking mechanism is a movable protrusion of an inner surface of the housing which forms the-cavity, and is movable by the end of the handle to release the tip.
The package is made from a single piece of molded material, which may be a clear plastic material such as co-polyester PETG or polyvinyl chloride. The package is made by molding, such as vacuum molding.
In another general aspect of the invention, the package includes a top portion, a bottom portion, and a hinging segment connecting the top portion and the bottom portion. The top portion and the bottom portion form a tip cavity when the top portion and the bottom portion are folded together along the hinging segment. The tip cavity is shaped to receive the tip and has an opening through which the end of the handle is insertable for removable attachment to the tip.
Preferred embodiments may also include one or more of the following features.
A releasable locking mechanism, including a releasable locking recess formed in the top portion and the bottom portion, holds the tip within the tip cavity. The locking mechanism is releasable in response to the end of the handle being disposed in the opening for removable attachment to the tip.
The tip includes a protrusion, and the top portion includes a positioning cavity shaped to receive the protrusion to prevent the tip from rotating within the tip cavity. The end of the handle has a bevel, and the locking mechanism has a ramp disposed adjacent to the locking recess so that the bevel contacts the ramp to release the locking mechanism.
The top and bottom portions include several molded features. For example, the top portion includes a molded pocket and the bottom portion includes a molded boss, the boss engaging the pocket to hold the top portion and the bottom portion together when folded along the hinging segment. The top and bottom portions also include interlocking ribs. The top portion includes a molded placement indicator to indicate placement of a user's fingers, and a molded directional indicator to indicate a direction of movement of the handle in the tip cavity.
In use, a tip disposed within the package is attached to the end of a handle by inserting the end of the handle into the package opening to release the tip, pushing the end of the handle inserted into the opening to attachably engage the tip to the end of the handle, and withdrawing the end of the handle from the opening with the attachably engaged tip. Similarly, the tip is detached from the handle and stored in the package by inserting the end of the handle with the removably attached tip into the package opening, pushing the end of the handle inserted into the opening until the tip is released and retained in the package, and withdrawing the end of the handle from the opening. Pressure may be applied to and released from the package to assist in the attachment of the tip onto and the removal of the tip from the handle.
The invention is particularly well-suited, but by no means limited, for use with bipolar electrosurgical devices with removable bipolar tips which can be easily and conveniently detached from the handle, such as the devices disclosed in the parent application.
Thus, in one embodiment, the tip is attachable to a handle having an opening and a plurality of coaxial, axially spaced electrical contacts. The tip includes a tip housing having a proximal end and a distal end, the proximal end of the tip housing configured to be received within the opening of the handle. A plurality of electrodes are disposed through the tip housing, the electrodes having distal ends that extend distally from the distal end of the tip housing and proximal ends that are coaxial and axially spaced from each other and that extend proximally from the proximal end of the tip housing for connection to the coaxial, axially spaced electrical contacts of the handle when the proximal end of the tip housing is inserted in the opening of the handle. The proximal end of the tip housing is constructed to be releasably secured to the handle (e.g., by a snap fit) for operation of the surgical device solely by inserting the proximal end of the tip housing axially into the opening of the handle. The package has a tip cavity shaped to receive the tip. In an alternative embodiment, the tip is a sharp tip.
In use, the user simply selects a packaged tip from an inventory of such tips, and installs the tip onto the device handle in the manner described above. The device is then ready for use in surgery. After it is used, the tip is removed from the handle and stored in the package, using the procedure described above, and discarded or stored for subsequent use during the same surgical procedure. If desired, another packaged tip may be selected, inserted onto the handle, and used to perform a different treatment (e.g., cauterization) during the same surgical procedure.
The package securely retains and protects each tip, thereby eliminating several safety and sterility concerns that accompany the use of removable surgical tips. Among other advantages, the package eliminates the need for the user's hand to contact the tips during either installation or removal of the tips. Use of the package prevents contamination or exposure by the user to used tips. Further, tips delivered in sterile packages can be attached to the handle without risking contamination from the user's hands.
The package allows for simple insertion of tips onto and removal of tips from the handle of the surgical device. The package may be shaped to accommodate various types of tips used with the handle. The package, which may permit the user to see the tip inside, allows for efficient organization of tips during a surgical procedure.
The package also protects the user from the sharp ends of the tips' electrodes. The interlocking ribs of the top and bottom portions and the hinging segment help to avoid accidental release of the tip retained in the package and to prevent the sharp end of the tip electrode from sliding out through the sides of the package. Also, the electrical contacts of the tip electrodes that attach to the handle are recessed in the opening of the housing to avoid accidental contact with the user's hands.
Other features and advantages of the invention will become apparent from the following description and from the claims.
REFERENCES:
patent: 2953243 (1960-09-01), Roehr
patent: 3785051 (1974-01-01), Dawidowicz et al.
patent: 4173285 (1979-11-01), Kiraly et al.
patent: 4548207 (1985-10-01), Reimels
patent: 4732149 (1988-03-01), Sutter
patent: 4823791 (1989-04-01), D'Amelio et al.
patent:
Crocetta, Jr. Michael J.
Johnson Wayne
Shapeton Mark
Fidei David T.
Medtronic Xomed, Inc.
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