Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1999-10-13
2001-10-23
Casler, Brian L. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C606S002000, C606S015000
Reexamination Certificate
active
06308092
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to guide wires used to localize lesions and relates more specifically to guide wires incorporating optical fibers to facilitate visually locating the forward end of the guide wire.
BACKGROUND OF THE INVENTION
Ultrasound, mammography, magnetic resonance imaging, and other medical imaging modalities are widely used to identify suspicious lesions within the body of a patient. Historically, when a suspicious lesion is located within the body of a patient, a guide wire was inserted by the physician to mark the location of the lesion to enable a surgeon to locate the lesion for removal. The guide wires typically include barbs or hooks at their forward ends to securely anchor the guide within the target tissue.
A problem with such guide wires, however, is that it is sometimes difficult for the surgeon to locate the forward end of the guide wire. While tugging on the guide wire will cause movement at the forward end which the surgeon can visually identify, the tugging action can also dislodge the guide wire from the target tissue. Accordingly, another method of locating the forward end of a guide wire was needed.
To address this problem, the prior art discloses a guide wire fabricated from an optical fiber. Hooks were affixed to the forward end of the optical fiber to anchor the tip of the fiber in the target tissue. The free end of the optical fiber was hooked up to a small laser, and a beam of light was directed through the fiber. A diffuser tip at the forward end of the guide wire created a point of light which could easily be visualized by a surgeon through several centimeters of tissue, thereby facilitating the location of the forward end of the guide wire. U.S. Pat. No. 5,782,771 to Hussman and an article entitled
Optical Breast Lesion Localization Fiber: Preclinical Testing of a New Device
from the September 1996 issue of RADIOLOGY describe the optical fiber localization device in detail.
While this prior art device represents an improvement in terms of locating the forward end of the guide wire without dislodging the guide wire from the tissue, there are significant structural problems inherent in the design of the device. Specifically, the optical fiber incorporates a stepdown portion at the forward tip of the fiber to diffuse the transmitted light. This step-down portion, however, also creates a structural weakness that is exacerbated by the hooks being mounted to the reduced portion. In short, any significant torque on the hooks can cause the tip of the optical fiber to break off.
Thus there is a need for an optical fiber tissue localization device which better resists breakage in response to torque exerted by the hooks.
There is a further need for an optical fiber tissue localization device which meets the foregoing needs while being inexpensive to manufacture.
SUMMARY OF THE INVENTION
Stated generally, the present invention comprises an improved tissue localization device of the type which employs an optical fiber, the forward tip of which is anchored within the target tissue by hooks affixed to the device and illuminates to facilitate localization of the target tissue by the physician. The optical fiber tissue localization device of the present invention better resists breakage of the optical fiber in response to torque exerted by the hooks.
Stated somewhat more specifically, the present invention relates to an apparatus for marking a location within the tissue of a patient. An optical fiber has a forward end shaped into a tapered tip. A strain relief tube is disposed around the outer diameter of the optical fiber adjacent the forward end of the optical fiber. An anchor means is mounted to the strain relief tube for engaging the tissue of a patient to secure the tip of the optical fiber within the tissue of the patient. The anchor means may be deployed to anchor the tip of the optical fiber in the vicinity of a location desired to be marked. The rearward end of the optical fiber is optically coupled to a light source to transmit light through the optical fiber to illuminate the tip, thereby to facilitate a physician in visually locating the tip.
Thus it is an object of the present invention to provide an improved optical fiber tissue localization device.
It is another object of the present invention to provide an improved optical fiber tissue localization device which is less susceptible to breakage resulting from torque exerted by the hooks which anchor the fiber within the target tissue.
Other objects, features, and advantages of the present invention will become apparent upon reading the following specification, when taken in conjunction with the drawings and the appended claims.
REFERENCES:
patent: 4007732 (1977-02-01), Kvalve et al.
patent: 4567882 (1986-02-01), Heller
patent: 5111828 (1992-05-01), Kornberg et al.
patent: 5643251 (1997-07-01), Hillsman et al.
patent: 5722426 (1998-03-01), Kolff
patent: 5782771 (1998-07-01), Hussman
patent: 6129683 (2000-10-01), Sutton et al.
Optical Breast Lesion Localization Fiber: Preclinical Testing of a New Device,Radiology, Sep. 1996, pp. 865 and 866.
C. R. Bard Inc.
Casler Brian L.
Kilpatrick & Stockton LLP
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