Surgery – Body protecting or restraining devices for patients or infants – Drapes
Reexamination Certificate
2001-08-31
2004-01-20
Lucchesi, Nicholas D. (Department: 3764)
Surgery
Body protecting or restraining devices for patients or infants
Drapes
C359S510000
Reexamination Certificate
active
06679267
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the field of undistorted transmission of a collimated visible light beam through an optically clear material. More particularly, the invention relates to a sterile drape, which allows a laser beam to pass through a clear portion of the drape while maintaining clarity of projection and precision of alignment of the beam. The drape helps maintain a sterile environment in an operating or diagnostic setting where a laser targeting system and imaging equipment, such as a fluoroscope, are used.
2. Background Art
Many diagnostic and surgical procedures involving complex devices or calling for use of multiple medical tools and pieces of equipment must be performed in a sterile operating environment. Most known medical procedures require a surgeon or a technician to identify a position of a particular region of interest inside a patient's body and later access that region to perform the required operation. Identifying a region of interest inside the patient is often done with the help of imaging equipment, such as fluoroscopes, computer tomographs (CT scanners), or magnetic resonance imaging equipment (MRI), which are commonly known and widely used for diagnostic and surgical purposes.
Imaging equipment is often used in conjunction with a targeting system, which emits a collimated visible light beam, such as a laser beam. In many applications the laser beam is used by a surgeon to specify the location and direction of entry into a patient's body for such procedures as biopsies, bone fixations and other precision operations normally performed using fluoroscopic methods.
When the desired region, or a subsurface target, inside a patient is ascertained, a surgeon needs to determine the preferred path of approaching and reaching the target in order to perform a surgery or another invasive medical procedure. A targeting system helps the surgeon to determine such a path. The visible light beam of the targeting system illuminates the selected path, making it a visible and convenient guide to the subsurface target. The direction of the light beam represents the angle of approach to the target. Furthermore, the light beam projects a dot on the skin of the patient, marking it as a point of entry to the internal region of interest, so that the region can be reached with a minimal error. An example of a laser targeting system for use during fluoroscopic procedures is a Dual Radiation Targeting System (DRTS), manufactured and marketed by MINRAD.
It is also often the case that the imaging equipment or the targeting system used with the imaging equipment can not be easily sterilized, so various sterile drapes are used to maintain sterile conditions in the room where operations or diagnostic procedures are performed. Standard sterile drapes are usually pliable plastic drapes. These drapes are usually clear and acceptable for many applications, including those requiring a user to operate equipment through the drape. However, such drapes can not provide clarity required for laser transmission. Without a drape, the accuracy of a laser beam is +/−1 mm at a distance of 1 meter, and the laser beam projects a dot approximately 1 mm in diameter. When propagating through clear drapes, the laser beam is usually distorted both in clarity of the projection of the dot and in the precision of identification of the subsurface target to which the surgeon is directed by the beam.
Sterile drapes known in the art and used specifically for imaging and targeting equipment are usually optically clear, or transparent, but these drapes distort the quality of projection of the laser beam in both clarity and direction for a variety of reasons. Furthermore, any movement or displacement of the drape from its intended position, can alter the clarity of transmission and precision of projection of the laser beam on the skin of the patient. Errors in the position of the beam or in the location of the entry point are consistently created by the use of existing sterile drapes.
For example, U.S. Pat. No. 5,490,524 to Williams et al. discloses a surgical drape for use with a laser targeting device mounted on an x-ray machine. In that patent a transparent window of flexible acetate film is attached to the x-ray transparent sheet material of the drape. There are two apparent disadvantages in the flexible acetate window disclosed in that patent. The first disadvantage relates to the fact that a flexible window may become curved from packaging or storage pressure, or when the drape is wrapped around laser targeting device. If the drape bends or curves, it becomes a cross section of a meniscus lens, diverting an incident light beam from its desired direction. The second disadvantage lies in the inability of is acetate films to withstand the process standardly used to sterilize surgical drapes during manufacture—the gamma radiation sterilization. This type of sterilization causes acetate to yellow, thus, affecting the transmission of light having frequencies above 600 nm. It would be desirable, of course, to have a drape with an optically clear window made of such a material on which optical properties gamma sterilization will have minimal or no effect.
It would be also desirable to provide a drape which could be maintained in correct alignment with a targeting device in order to allow the light beam to exit the targeting device without refraction or distortion.
SUMMARY OF THE INVENTION
Accordingly it is an object of the present invention to provide for an optical window through which a laser beam can be transmitted without distortion or displacement.
It is another object of the present invention to provide an optically clear window which resists bending and remains rigid during packaging, storage and use.
It is yet another object of the present invention to provide a sterile surgical drape with an optically clear rigid window made of a material with optical properties remaining unaffected by the gamma-radiation sterilization process.
It is also an object of the present invention to provide a surgical drape with a window, which will allow one to detect misalignment between the disk and a laser beam of the laser targeting device.
The sterile drape of the present invention overcomes disadvantages described with regard to existing sterile drapes. The present invention provides a sterile drape, which consists of two components: a sterile bag for covering a targeting device and a window for clear and undistorted transmission of the light beam emitted by the targeting device.
The sterile drape includes a plastic drape with an optically clear window made of a variety of optically clear polymers that resist bending or curving. The drape is adapted to being wrapped around a targeting device used together with imaging equipment, such as, for example, a fluoroscope. Both clarity and precision of projection of the laser beam are preserved when the window is properly aligned on the laser targeting device. If the window is misaligned, the laser beam projects a primary beam and a second, smaller laser beam, which is refracted away by the misaligned window from the desired path and location. The second beam, therefore, serves as an indicator of the degree and direction of misalignment. When the misalignment is detected, the positions of the window and the drape can be easily adjusted on the targeting device with the help of a drape window positioning device to allow for the undistorted and undeflected transmission of the laser beam from the targeting device to the patient.
Still other objects and advantages of the present invention will become readily apparent to those skilled in this art from the following detailed description, wherein a preferred embodiment is shown and described, simply by way of illustration of the best mode contemplated by the inventor for carrying out the invention. As will be realized, the invention is capable of other and different embodiments and its several details are capable of modifications in various obvious res
Burns, Jr. William H.
McNeirney John C.
Hodgson & Russ LLP
Hwang Victor
Lucchesi Nicholas D.
Minrad Inc.
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