Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1998-02-17
2001-01-16
Lateef, Marvin M. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S431000, C600S007000, C606S116000
Reexamination Certificate
active
06175760
ABSTRACT:
TECHNICAL FIELD OF THE INVENTION
The present invention relates to medical devices for marking locations for subsequent surgery. Particularly, the invention relates to a localizing device utilizing nuclear medicine imaging.
BACKGROUND OF THE INVENTION
It is well known that cancer is a deadly disease. Early detection and treatment are essential to improving a patient's ability to avoid life-threatening complications and to maximize their chances of survival. One such method of early detection involves non-invasive examination of the patient to identify lesions. As these lesion areas may include cancerous or other diseased tissue, once detected they can be surgically removed.
When radiograms or X-rays are used to locate lesions, as in periodic mammogram screens for breast cancer, a guidewire, needle, or similar device can be placed in the tissue as close as possible to the lesion so that the lesion location may be identified during subsequent surgery. As the localizing device and the lesion itself are both visible to radiograms and X-rays, the relative location of the lesion with respect to the localizing device can be determined by examining a radiograph of the lesion site with the localizing device inserted. However, since it is normally impossible to distinguish lesion tissue from normal healthy tissue by sight or feel, and the radiograph is not always available or usable during surgery, the surgeon must rely only on the localizing device and the earlier radiogram to determine the lesion site during surgery. Accurate determination of the location of the lesion from the localizing device allows the surgeon to approach the site accurately, remove a relatively small amount of tissue and yet still be confident that all the lesion tissue is removed. Several devices have been directed toward increasing the accuracy of localizer placement with respect to the lesion site. For example, inventions to more securely anchor the localizing device in the tissue to prevent inadvertent localizer movement prior to surgery are disclosed in U.S. Pat. Nos. 4,616,656 to Nicholson et al. and 5,221,269 to Miller et al. Additionally, a device which incorporates radiopaque markings at predetermined positions along the axial length of the localizer to further assist in identifying the relative location of the lesion is disclosed in U.S. Pat. No. 5,409,004 to Sloan.
However, many lesions are undetectable through radiographic means due to their depth in the tissue or their proximity to bone material. In these cases, alternative detection means are necessary. One such recently developed alternative involves inoculating the patient with a radioactive isotope which preferentially absorbs in lesion tissue. The presence of the radioactive isotope in the lesions makes the lesion visible to nuclear medicine scans.
One limitation generally associated with the prior art localizing devices is that they are insufficiently visible for use with the localizing techniques developed for nuclear medicine scanning. Another limitation of the prior art localizing devices is that they are limited for use in soft tissue material, such as female breast tissue.
SUMMARY OF THE INVENTION
One aspect of the present invention contemplates an apparatus including a radioactive capsule capable of being anchored in bone as a marker for subsequent surgery. Another aspect of the present invention contemplates a method of localizing lesions in hard tissue by installing a radioactive marker securely in bone adjacent the lesion and which has a cable extending from the marker to the exterior of the patient's skin to identify an entry site for subsequent surgery to remove the lesion. The method includes placement of a localizing marker needle with a radiation source imbedded near its distal point, and a flexible cable extending from its proximal end, inside a guide needle. The guide needle with the localizing needle so-installed, is introduced through the patient's skin and observed on a radiation persistence scope, displaying the lesion, which is visible on the scope due to an accumulation of a radioactive isotope in the lesion. The guide needle with the localizing needle therein is advanced with the help of the imaging scope to a point of contact of a needle with the bone adjacent the lesion. According to a method with one embodiment of the invention, the localizing needle has helical hooks at its distal end and, with the guide needle held against the bone, and a torque applying handle connected to the proximal end of the cable, the cable is turned to screw the hooks into the bone. Then the torque-applying handle is removed from the cable, the guide needle is removed, and the portion of the cable outside the body is taped to the skin to be readily located when the patient is moved to a site for subsequent surgery. According to the preferred embodiment of the invention, the localizing needle has a screw threaded point. After locating the threaded point on the bone adjacent the lesion, and then holding the point of the guide needle securely on the bone adjacent the lesion, the localizing needle is withdrawn from the guide needle. Then a sharp-pointed T-handled drill shaft is inserted through the guide needle to the bone and turned to drill a starter hole in the bone. Then the drill is removed, and the localizing needle re-inserted and the sharp, screw-threaded tip thereof is inserted into the starter hole. A needle driver releasably coupled to the proximal end of the localizing needle and having a handle portion extending outside of the guide needle, is engaged with and used to rotate and thereby drive the screw tip of the localizing needle into the bone for anchorage thereof. When the stability and accuracy of location of the localizing needle relative to the lesion are observed in the scope, the needle driver is removed and the guide needle is removed and the portion of the cable protruding from the skin is then taped to the skin for marking the entrance location for subsequent surgery.
The primary object of the present invention is to provide apparatus and method for providing accurate localization prior to treatment, of sites for surgery or other treatment for bony lesions detectable by radionuclide imaging prior to surgery or other treatment.
REFERENCES:
patent: 2269458 (1942-01-01), Kahn
patent: 3674006 (1972-07-01), Holmer
patent: 3811426 (1974-05-01), Culver et al.
patent: 4086914 (1978-05-01), Moore
patent: 4096862 (1978-06-01), DeLuca
patent: 4402308 (1983-09-01), Scott
patent: 4616656 (1986-10-01), Nicholson et al.
patent: 4627420 (1986-12-01), Katz
patent: 4781198 (1988-11-01), Kanabrocki
patent: 4787384 (1988-11-01), Campbell et al.
patent: 4787391 (1988-11-01), Elefteriades
patent: 4815449 (1989-03-01), Horowitz
patent: 4861520 (1989-08-01), Van't Hooft et al.
patent: 4957476 (1990-09-01), Cano
patent: 4969863 (1990-11-01), Van't Hooft et al.
patent: 5037426 (1991-08-01), Goble et al.
patent: 5154179 (1992-10-01), Ratner
patent: 5183455 (1993-02-01), Hayman et al.
patent: 5195526 (1993-03-01), Michelson
patent: 5199939 (1993-04-01), Dake et al.
patent: 5221269 (1993-06-01), Miller et al.
patent: 5234426 (1993-08-01), Rank et al.
patent: 5282781 (1994-02-01), Liprie
patent: 5320100 (1994-06-01), Herweck et al.
patent: 5361766 (1994-11-01), Nichols et al.
patent: 5399868 (1995-03-01), Jones et al.
patent: 5409004 (1995-04-01), Sloan
patent: 5425733 (1995-06-01), Schmieding
patent: 5429617 (1995-07-01), Hammersmark et al.
patent: 5540659 (1996-07-01), Teirstein
patent: 5591207 (1997-01-01), Coleman
patent: 5595193 (1997-01-01), Walus et al.
patent: 5606981 (1997-03-01), Tartacower et al.
patent: 5626613 (1997-05-01), Schmieding
patent: 5647374 (1997-07-01), Cutrer
patent: 5662111 (1997-09-01), Cosman
patent: 5665092 (1997-09-01), Mangiardi et al.
patent: 5682890 (1997-11-01), Kormos et al.
patent: 5687739 (1997-11-01), McPherson
patent: 5772594 (1998-06-01), Barrick
patent: 5800445 (1998-09-01), Ratcliff et al.
patent: 5810841 (1998-09-01), McNeirney et al.
patent: 5853366 (1998-12-01), Dowlatshahi
patent:
Barnhart William H.
Baskin Kevin M.
Lateef Marvin M.
Shaw Shawna J
University of Iowa Research Foundation
Woodard Emhardt Naughton Moriarty & McNett
LandOfFree
Lesion localizer for nuclear medicine does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Lesion localizer for nuclear medicine, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Lesion localizer for nuclear medicine will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2533343