Surgery – Diagnostic testing – Detecting nuclear – electromagnetic – or ultrasonic radiation
Reexamination Certificate
1999-10-13
2002-05-21
Smith, Ruth S. (Department: 3737)
Surgery
Diagnostic testing
Detecting nuclear, electromagnetic, or ultrasonic radiation
C600S478000, C606S002000
Reexamination Certificate
active
06393312
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to guide wires used to localize lesions wherein the guide wires incorporate optical fibers to facilitate visually locating the forward end of the guide wire. More specifically the invention relates to a connector for facilitating coupling the optical fiber of a tissue localization device to a light source.
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.
A problem with respect to prior art optical fiber tissue localization devices concerns the requirement of optically connecting the rearward end of the optical fiber to a light source. A coupling is typically employed to couple an optical fiber to a light source. However, in the case of an optical fiber tissue localization device, the forward end of the device is delivered through a hollow cannula, which must then be withdrawn over the length of the optical fiber and off the rearward end. To permit the cannula to be withdrawn over the rearward end of the optical fiber, the coupling cannot be mounted to the fiber until the forward end of the device is positioned within the patient and the cannula has been withdrawn. Accordingly, the coupling must be quickly, easily, and reliably mounted to the fiber under operating room conditions.
Thus there is a need for a quick-connect coupling for an optical fiber tissue localization device which can be quickly, easily, and reliably mounted to the fiber under operating room conditions.
A further problem concerns the possibility of contaminating the light source and the difficulty of sterilizing the light source. When the cannula is removed from the patient's tissues and withdrawn over the length of the cannula, the entire length of the optical fiber, including its rearward end which couples to the light source, is likely to become contaminated by contact of the contaminated cannula with the optical fiber. Consequently, when the rearward end of the optical fiber is coupled to the light source, the light source may become contaminated. Because it is difficult to sterilize the light source after each procedure, there is a need for an apparatus and method for coupling an optical fiber to a light source which avoids contamination of the light source. There is a further need for an apparatus and method for coupling an optical fiber to a light source wherein the coupling is inexpensive to manufacture, such that the coupling is disposable after a single-patient use.
SUMMARY OF THE INVENTION
Stated generally, the present invention comprises a quick-connect coupling for an optical fiber tissue localization device which can be quickly, easily, and reliably mounted to the fiber under operating room conditions. The coupling physically isolates the optical fiber from the light source while optically coupling the fiber to the light source, thereby preventing contamination of the light source by a contaminated optical fiber. The coupling is inexpensive to manufacture, such that the coupling is disposable after a single-patient use.
Stated somewhat more specifically, an optical fiber has anchor means operatively associated with a forward portion for engaging the tissue of a patient to secure the tip of the optical fiber within the tissue of the patient. A light source is mounted to a mount. A coupling means is provided for coupling the rearward end of the optical fiber to the mount so as to optically couple the light source to the optical fiber.
Thus it is an object of the present invention to provide an improved connector for coupling an optical fiber tissue localization device to a light source.
It is another object of the present invention to provide a quick-connect coupling for an optical fiber tissue localization device which can be quickly, easily, and reliably mounted to the fiber under operating room conditions.
Still another object of the present invention is to provide an apparatus and method for coupling an optical fiber to a light source which avoids contamination of the light source.
It is yet another object of the present invention to provide an apparatus and method for coupling an optical fiber to a light source in accordance with the foregoing objects wherein the coupling is inexpensive to manufacture, such that the coupling is disposable after a single-patient use.
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.
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C. R. Bard Inc.
Kilpatrick & Stockton LLP
Smith Ruth S.
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