Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-05-08
2002-11-19
Walberg, Teresa (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S104000, C604S106000, C604S107000, C606S198000
Reexamination Certificate
active
06482178
ABSTRACT:
BACKGROUND OF THE INVENTION
Localization devices are frequently used in the treatment of tumors to guide treatment to a specific location under fluoroscopy or ultrasound. These devices can be manipulated to engage tissue at the target site via one or more barbs, tines, or other structures to prevent dislodgement or to stabilize the region be treated. During a procedure, there often is a tendency for an organ or other anatomical body to shift as it is being manipulated. Certain procedures optimally require stabilizing the position of the target structure such that precise placement of treatment can occur. For example, in brachytherapy of the prostate, interstitial anchoring devices immobilize the prostate at a fixed distance from a template to allow a brachytherapy needle to penetrate to a known depth for the placement of the radioactive seed. In other applications, anchoring of the target tissue or structure is followed by treatment to same site. The usual practice is for a separate surgical instrument to be guided to the site marked by the localization device. Placement of the second device usually requires a second entry site and increases the duration that the patient is under fluoroscopy.
SUMMARY OF THE INVENTION
The foregoing problems are solved and a technical advance is achieved in an illustrative embodiment of a localization device comprising an outer needle cannula, optionally with a sharp beveled tip, an inner sleeve cannula and an anchor stylet comprising a plurality of preformed superelastic alloy wires that once deployed from the end sleeve and needle cannulae, function as curved barbs projecting outward to anchor the device into tissue, an organ, or a foreign body. The combination of the anchoring wires and sleeve cannula can be removed from the outer needle cannula so that medicants or other materials can be infused at the anatomical site through the needle cannula. If desired, the sleeve cannula and anchoring wires can be easily reintroduced into the needle cannula. Without the sleeve cannula to recompress the anchoring wires for reloading, it would be very difficult to load the anchor stylet with its outwardly-projecting barbs into the needle cannula. In one embodiment, a smaller inner cannula is used to secure the anchoring wires together and facilitate axial movement of the anchor stylet within the sleeve cannula. Possible uses of the localization device include positioning the anchor at a target site and removing the outer needle cannula over the anchor stylet and sleeve cannula. A dilator and sheath can then be placed over the anchor such that a catheter, or other device (e.g., a cryoprobe) can been introduced to the desired location, usually following removal of the anchor stylet and sleeve cannula.
In another embodiment of the present invention, a slidable collet or other locking member, such as a pin vise, can be included over the outer needle cannula for securing the anchoring device against a template such as the type used in a brachytherapy or hyperthermia treatment procedure. The locking member can made to be removable from the proximal end to permit advancement of another device over the needle.
In another aspect of the invention, the surface of the outer needle cannula about the distal end can be made to be echogenic for visibility under ultrasound. Additionally, the radiopacity of the device can be enhanced by the addition of a well-known, biocompatible radiopaque material such as tantalum, platinum, gold, etc., to one or more device components.
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Andrews Marvin O.
Fischer, Jr. Frank J.
Ward John H.
Cook Urological Incorporated
Dahbour Fadi H.
Hunt James B.
Walberg Teresa
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