Thermal treatment system and method for maintaining...

Electric heating – Heating devices – Combined with container – enclosure – or support for material...

Reexamination Certificate

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C219S438000, C219S433000, C604S114000, C604S291000, C004S655000

Reexamination Certificate

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06255627

ABSTRACT:

BACKGROUND OF THE INVENTION
1. Technical Field
The present invention pertains to improvements in methods and apparatus for heating or cooling sterile surgical liquids and collecting surgical sterile slush. In particular, the present invention is an improvement of the methods and apparatus disclosed in U.S. Pat. No. 4,393,659 (Keyes et al), U.S. Pat. No. 4,934,152 (Templeton), U.S. Pat. No. 5,163,299 (Faries, Jr. et al), U.S. Pat. No. 5,331,820 (Faries, Jr. et al), U.S. Pat. No. 5,333,326 (Faries, Jr. et al), U.S. Pat. No. 5,457,962 (Faries, Jr. et al), U.S. Pat. No. 5,522,095 (Faries, Jr. et al), U.S. Pat. No. 5,524,643 (Faries, Jr. et al) and U.S. Pat. No. 5,615,423 (Faries, Jr. et al), and copending U.S. patent application Ser. No. 08/807,095, entitled “Surgical Drape and Stand for Use in Thermal Treatment Basins”, filed Feb. 27, 1997. The disclosures of the aforementioned patents and copending patent application (i.e., U.S. patent application Ser. No. 08/807,095) are incorporated herein by reference in their entireties.
2. Discussion of Related Art
The above-referenced Keyes et al U.S. Pat. No. (4,393,659) discloses a surgical slush producing system having a cabinet with a heat transfer basin located at its top surface. A refrigeration mechanism in the cabinet takes the form of a closed refrigeration loop including: an evaporator in heat exchange relation to the outside surface of the heat transfer basin; a compressor; a condenser; and a refrigeration expansion control, all located within the cabinet. A separate product basin is configured to be removably received in the heat transfer basin. Spacers, in the form of short cylindrical stubs or buttons, are arranged in three groups spaced about the heat transfer basin and projecting into the heat transfer basin interior to maintain a prescribed space between the two basins. During use, that space contains a thermal transfer liquid, such as alcohol or glycol, serving as a thermal transfer medium between the two basins. A sterile drape, impervious to the thermal transfer medium, is disposed between the product basin exterior and the liquid thermal transfer medium to preserve the sterile nature of the product basin. Surgically sterile liquid, such as sodium chloride solution, is placed in the product basin and congeals on the side of that basin when the refrigeration unit is activated. A scraping tool is utilized to remove congealed sterile material from the product basin side to thereby form a slush of desired consistency within the product basin. Some users of the system employ the scraping tool to chip the solid pieces from the basin side.
As noted in the above-referenced Templeton U.S. Pat. No. (4,934,152), the Keyes et al system has a number of disadvantages. In particular, the separate product basin must be removed and re-sterilized after each use. Additionally, the glycol or other thermal transfer medium is typically highly flammable or toxic and, in any event, complicates the procedure. The Templeton patent discloses a solution to these problems by constructing an entirely new apparatus whereby the product basin is eliminated in favor of a sterile drape impervious to the sterile surgical liquid, the drape being made to conform to the basin and directly receive the sterile liquid. Congealed liquid is scraped or chipped from the sides of the conformed drape receptacle to form the desired surgical slush.
The Faries, Jr. et al U.S. Pat. No. (5,163,299) notes that scraping congealed liquid from the drape is undesirable in view of the potential for damage to the drape, resulting in a compromise of sterile conditions. As a solution to the problem, the Faries, Jr. et al U.S. Pat. No. (5,163,299) proposes that the drape be lifted or otherwise manipulated by hand to break up the congealed liquid adhering to the drape. Although this hand manipulation is somewhat effective, it is not optimal, and often is inconvenient and constitutes an additional chore for operating room personnel.
The Faries, Jr. et al U.S. Pat. No. (5,331,820) resolves the problem of manual manipulation of the drape by providing a method and apparatus to automatically remove congealed liquid adhering to the drape without endangering the integrity of the drape. A flat disk or plate is typically provided at the bottom of the basin under the drape. The plate is moved in an up and down manner to manipulate the drape and disengage the congealed liquid adhering to the drape. The plate may be attached to a mechanism below the basin, or to the drape itself as disclosed in the Faries, Jr. et al U.S. Pat. No. (5,457,962).
In addition to accommodating surgical slush, the Templeton patent provides an electrical heater disposed at the bottom of the basin to convert sterile surgical slush to warmed sterile liquid, or to heat additional sterile liquid added to the basin. The electrical heater typically includes a heating element in the form of a thin wafer having a circular opening defined at the center of the heating element. A threaded stud projects through the opening to engage a heating plate via a nut and lock washer. The heating plate serves to dissipate excess heat from the heating element within a system cabinet and to aid in securing the heating element against the basin. The lock washer is typically constructed of an insulating material to minimize heat transfer between the heating element and stud, thereby preventing formation of a hot spot at the center of the basin floor that may melt the drape during system operation. The Templeton patent describes the need for warm sterile liquid as occurring after a surgical procedure is completed to facilitate raising the body cavity of the surgery patient back to its normal temperature by contact with the warmed liquid. However, there are a number of instances during a surgical procedure when it is desirable to have simultaneous access to both warmed sterile liquid and sterile surgical slush. For example, if the surgical slush is not of a desired consistency (e.g., too thick), the availability of warm sterile liquid to be added to the slush permits rapid adjustability of slush consistency. Likewise, maintaining instruments at or near body temperature during surgery is a desirable feature permitted by warm sterile liquid. Generally, if warm sterile liquid is simultaneously available with surgical slush, there is no need to wait for the slush to melt at the end of the surgical procedure. Moreover, the simultaneous provision of sterile surgical slush and warm sterile liquid permits the two to be comprised of different compounds as is sometimes necessary for various surgical procedures.
In response to the foregoing need for simultaneous availability of warmed sterile liquid and sterile surgical slush, the Faries, Jr. et al U.S. Pat. Nos. (5,333,326, 5,522,095 and 5,524,643) disclose a thermal treatment system of the type having at least a warming basin for containing warm surgical liquid and a surgical slush or cooling basin of the type disclosed in the Templeton patent. The warming basin may be implemented as a separate unit and secured to a preexisting surgical slush system (e.g., a thermal treatment system having a cooling basin to produce surgical slush), may be constructed as part of an integral cabinet that houses warming and cooling basins, or may be implemented as a separate unit and attached to an individual surgical slush unit a (e.g., a cooling basin producing surgical slush that is implemented as an individual unit) with the warming and surgical slush units supported by a common base. A large surgical drape covers both the warming and cooling basins and contains the warm surgical liquid and surgical slush in a sterile manner. In addition, the drape may include centering indicia to direct placement of the drape over the thermal treatment system and within each basin.
Typically, a sterile surgical drape is placed over a single or multiple basin thermal treatment system with a portion of the drape disposed within each thermal treatment system basin to form a drape receptacle within each basin for containing a sterile liqu

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