Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Thermal applicators
Reexamination Certificate
1998-08-21
2001-05-15
Dvorak, Linda C. M. (Department: 3739)
Surgery: light, thermal, and electrical application
Light, thermal, and electrical application
Thermal applicators
C607S112000, C126S263020, C126S263070
Reexamination Certificate
active
06231596
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates generally to the field of surgical instrumentation and consumable items associated therewith. More specifically, the present invention relates to a disposable device for warming surgical instruments.
BACKGROUND OF THE INVENTION
Surgical use of laproscopic or endoscopic instruments has become more frequent in recent years. Once used almost exclusively for orthopedic procedures, the use of endoscopic devices has expanded to corrective procedures associated with the shoulder and spine. Additionally, endoscopic devices enjoy an expanded use in imaging the interior viscera including interior surfaces of the stomach, small intestines, and colon. The use of endoscopic devices has been expanded to heart surgery as well and for the removal of gall bladders. Each application dictates a specific shape of an endoscope.
In the operating room environment, a first sterile back field is arranged and configured to accept and store surgical instrumentation, where the surgical assistant works to organize, prepare and manage orthoscopic equipment before, during and after surgery. After preparation for surgery, the patient lies in a second sterile back field immediately surrounding the patient. During endoscopic surgery, the surgeon or his assistant may place the endoscope in the first sterile back field adjacent to other surgical instruments before and between uses.
One problem common to the use of endoscopic devices relates to the temperature difference between the operating room air and that of the human tissue. For example, the operating room temperature is approximately 14° C. to approximately 18° C., which is considerably lower than the 37° C. body temperature of a patient. If a surgeon inserts an endoscope at operating room temperature into an incision at body temperature, the moisture in the incision condenses on the endoscope lens as a result of the temperature difference in the moist environment Lens condensation impedes image input to the camera and further causes a distorted or blurry video signal, which impedes a surgeon's ability to view a patient's anatomy in the operative anatomical area.
Surgeons have developed techniques to prevent an endoscopic lens from fogging due to temperature differences between the scope and patient tissue. A most common solution eliminates the temperature difference between the scope and tissue by warming the scope prior to insertion in patient tissue so that there will be no condensation on the scope. Several warming techniques are commonly known.
One warming technique utilizes an electric warming pad to heat the scope. Although effective at raising the endoscope temperature, problems arise out of the requirement for a power source for warming pads. The endoscopic surgical environment typically abounds with cable feeds from fiber optic equipment, video feeds and power lines. Thus, an additional cable for a warming pad is undesirable in that it adds to the operating room clutter. Furthermore, if operating room personnel trip over the cord, the endoscope may fall from its table to the floor and become damaged. Endoscopes are extremely expensive and such falling risks are undesirable.
Another solution to the problem of condensation forming on the lens of a scope entails immersing the endoscope in a sterile saline bath maintained at least at body temperature. Disadvantages associated with the saline immersion warming method include possible spillage of the saline solution, the cumbersome nature of an open liquid container in the operating room environment and the corrosive effect of the saline solution on the scope
With the forgoing disadvantages of the prior art in minds it is an object of the present invention to provide a warming device which safely warms a surgical instrument without the need for an energy source separate from the warming device.
It is another object of the present invention to provide a warming blanket which protects and encapsulates a surgical instrument such as an endoscope, in event that the endoscope falls from a table to a floor in the operating room environment.
It is another object of the present invention to provide a surgical warming device which is capable of withstanding gamma radiation for sterilization purposes.
It is another object of the present invention to provide a surgical instrument warming device which surrounds and protects the instrument sterility.
It is another object of the present invention to provide a surgical instrument warming device which maintains heat between uses on a single patient.
It is another object of the present invention to provide a surgical instrument warming device which is completely portable.
It is another object of the present invention to provide a surgical instrument warming device which assumes its own flat surface for facilitating stability of the surgical instrument on a surface in the sterile field.
It is another object of the present invention to provide a surgical instrument warming device which is opened in the secondary sterile field to maintain sterility of the warming device.
It is another object of the present invention to provide a surgical instrument warming device which has an upper heat limit to prevent tissue damage.
It is another object of the present invention to provide a surgical instrument warming device which absorbs fluids from the surgical instrument after use on a patient.
It is another object of the present invention to provide a surgical instrument warming device which is manufactured, inserted within a sealed bag, then sterilized.
Other objects, features and advantages of the present invention will become apparent upon reading the following specification, when taken in conjunction with the accompanying drawings.
SUMMARY OF THE INVENTION
Generally speaking, the present invention relates to an apparatus for warming a surgical instrument before and between uses on a single patient. More specifically, the present invention relates to a self-contained, disposable, single-use apparatus for warming and protecting a surgical instrument in a sterile back field.
The self-contained apparatus may essentially comprise a flexible outer bag enclosing heat generating compounds which become activated when mixed with one another and when exposed to air. A surgical assistant squeezes and/or shakes the outer bag to mix the interior components to initiate the generation of heat and wraps a surgical instrument, such as an endoscope, in the warmer, by folding the warmer about the instrument. The warming device then transfers enough heat to the endoscope necessary to raise the endoscope temperature to approximately body temperature, thereby preventing condensation of water vapor on a camera lens (fogging), which often occurs when a relatively cold endoscope contacts warm body tissue. The surgical warming device wraps around the instrument, takes no longer than approximately 15 minutes to heat the surgical instrument to approximately body temperature, is completely self-contained, and is easily discarded after a single use (a single use is considered to be one surgical procedure on a single patient).
In one embodiment of the present invention, the surgical instrument warming apparatus includes a sterile, flexible outer bag which contains the heat-generating materials and has external surfaces arranged and configured to fold about and to at least partially enclose a surgical instrument, wherein the outer bag includes an inner cavity and perforations through the outer bag for allowing air to pass into the outer bag inner cavity. Alternatively, the bag fabric may be air permeable for allowing air to pass to the outer bag inner cavity. The apparatus may also include an inner bag disposed within the cavity of the outer bag, wherein the inner bag includes perforations to pass air from the inner cavity of the outer bag to an inside cavity of the inner bag. The inner and outer bags may be formed from any material, and most preferably a non-woven web.
The inner bag includes in its inner cavity a heat generating composition which a
Dvorak Linda C. M.
Heat Max, Inc.
Ram Jacelyn
Thomas, Kaydon, Horstemeyer & Risley, LLP
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