CA2464651C

CA2464651C - Medical solution thermal treatment system and method of controlling system operation in accordance with detection of solution and leaks in surgical drape containers

Info

Publication number: CA2464651C
Application number: CA2464651A
Authority: CA
Inventors: Durward I. Faries, Jr.; Bruce R. Heymann; Calvin Blankenship
Original assignee: OR Solutions Inc
Current assignee: OR Solutions Inc
Priority date: 2001-10-22
Filing date: 2002-09-23
Publication date: 2010-07-13
Anticipated expiration: 2022-09-23
Also published as: WO2003039387A1; EP1446066A1; CA2464651A1; DE60209520T2; US20030075183A1; DE60209520D1; US6910485B2; EP1446066B1; US20030172937A1; AU2002336429B2; ATE318551T1; US6810881B2

Abstract

A drape including a sensing device is disposed over a thermal treatment system having a basin recessed therein to form a drape container or receptacle within the basin for collecting a sterile medium. The thermal treatment system may either heat or congeal the sterile medium. The sensing device is typically disposed through the drape to provide a signal indicating the presence of liquid and/or leaks within the drape container to the system to facilitate control of system operation. In addition, the sensing device may be affixed to a plural basin drape utilized for a multiple basin thermal treatment system.
The drape forms a drape receptacle within each basin, while a sensing device is typically disposed within each drape receptacle to detect the presence of liquid and/or a leak within that drape receptacle to facilitate control of system operation in substantially the same manner described above.

Description

MEDICAL SOLUTION THERMAL TREATMENT SYSTEM AND METHOD
OF CONTROLLING SYSTEM OPERATION IN ACCORDANCE WITH
DETECTION OF SOLUTION AND LEAKS IN SURGICAL DRAPE CONTAINERS

2 1. Technical Field

3 The present invention pertains to improvements in methods and apparatus for

4 thermally treating a sterile surgical liquid. In particular, the present invention pertains to a thermal treatment system employing a corresponding surgical drape to contain a sterile 6 surgical solution therein, wherein the presence of solution and/or leaks within the drape 7 container is detected to control system operation. The present invention is an improvement 8 ofthe methods and apparatus disclosed inU.S. PatentNos. 4,393,659 (Keyes et al), 4,934,152 9 (Templeton), 5,163,299 (Faries, Jr. et al), 5,331,820 (Faries, Jr. et al),

5,333,326 (Faries, Jr.
et al), 5,400,616 (Faries, Jr. et al), 5,402,644 (Faries, Jr. et al), 5,429,801 (Faries Jr. et al), 11 5,457,962 (Faries, Jr. et al), 5,502,980 (Faries, Jr. et al), 5,522,095 (Faries, Jr. et al), 5,524,643 12 (Faries, Jr. et al), 5,551,240 (Faries, Jr. et al), 5,615,423 (Faries, Jr.
et al), 5,653,938 (Faries, 13 Jr. et al), 5,809,788 (Faries, Jr. et al), 5,816,252 (Faries, Jr. et al), 5,857,467 (Faries, Jr. et al), 14 5,862,672 (Faries, Jr, et al), 5,879,621 (Faries, Jr. et al), 5,950,438 (Faries, Jr. et al), 6,003,328 (Faries, Jr, et al), 6,035,855 (Faries, Jr. et al), 6,087,636 (Faries, Jr. et al), 6,091,058 (Faries, 16 Jr. et al), 6,255,627 (Faries, Jr. et al) and copending U.S. Patent Application Serial No.
17 09/572,903, filed May 17, 2000 and entitled "Remote Controlled Thermal Treatment System 18 and Method for Controlling the System Remotely to Thermally Treat Sterile Surgical Liquid".
19 The disclosures in the above-mentioned patents and copending patent application are incorporated herein by reference in their entireties.
21 2. Discussion of the Related Art 22 The above-referenced Keyes et al patent (4,393,659) discloses a surgical slush 23 producing system having a cabinet with a heat transfer basin at its top surface. A refrigeration 24 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 26 compressor; a condenser; and a refrigeration expansion control, all located within the cabinet.

1 A separate product basin is configured to be removably received in the heat transfer basin.
2 Spacers, in the form of short cylindrical stubs or buttons, are arranged in three groups spaced 3 about the heat transfer basin and projecting into the heat transfer basin interior to maintain a 4 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

6 basins. A sterile drape, impervious to the thermal transfer medium, is disposed between the

7 product basin exterior and the liquid thermal transfer medium to preserve the sterile nature

8 of the product basin. Surgically sterile liquid, such as sodium chloride solution, is placed in

9 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 11 basin side to thereby form a slush of desired consistency within the product basin. Some users 12 of the system employ the scraping tool to chip the solid pieces from the basin side.
13 As noted in the above-referenced Templeton patent (4,934,152), the Keyes et al system 14 has a number of disadvantages. h1 particular, the separate product basin must be removed and re-sterilized after each use. Additionally, the glycol or other thermal transfer medium is 16 highly flammable or toxic and, in any event, complicates the procedure. The Templeton 17 patent (4,934,152) discloses a solution to these problems by constructing an entirely new 18 apparatus whereby the product basin is eliminated in favor of a sterile drape impervious to the 19 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 21 receptacle to form the desired surgical slush.
22 The Faries, Jr. et al patent (5,163,299) notes that scraping congealed liquid from the 23 drape is undesirable in view of the potential for damage to the drape, resulting in a 24 compromise of sterile conditions. As a solution to the problem, the Faries, Jr. et al patent (5,163,299) proposes that the drape be lifted or otherwise manipulated by hand to break up 26 the congealed liquid adhering to the drape. Although this hand manipulation is somewhat 27 effective, it is not optimal, and often is inconvenient and constitutes an additional chore for 28 operatingroompersonnel. Accordingly, several ofthe Faries, Jr. et alpatents (e.g., 5,331,820;
29 5,400,616; 5,457,962; 5,502,980; 5,653,938; 5,809,788; 5,857,467;
5,950,438; 6,003,328; and 6,035,855) resolve the problem of manual drape manipulation by disclosing various 1 techniques and/or dislodgment mechansms to automatically remove the congealed liquid 2 adhering to the drape without endangering the integrity of the drape.
3 The Templeton patent (4,934,152) further discloses an electrical heater disposed at the 4 bottom of the basin to convert the sterile slush to warmed liquid, or to heat additional sterile liquid added to the basin. Templeton describes the need for such warm sterile liquid as 6 occurring after a surgical procedure is completed to facilitate raising the body cavity of the 7 surgery patient back to its normal temperature by contact with the warmed liquid. However, 8 there are a number of instances during a surgical procedure when it is desirable to have 9 simultaneous access to both warmed sterile liquid and sterile surgical slush. Accordingly, several of the Faries, Jr. et al patents (e.g., 5,333,326; 5,429,801;
5,522,095; 5,524,643;
11 5,615,423; 5,653,938; 5,816,252; 5,862,672; 5,857,467; 5,879,621;
6,091,058; and 6,255,627) 12 disclose a mamler in which to simultaneouslyprovide both surgical slush and warmed surgical 13 liquid during a surgical procedure by utilizing a machine having plural basins with each basin 14 either producing surgical slush or heating a sterile liquid. This machine typically utilizes a single surgical drape that forms a drape receptacle within each basin to collect sterile slush 16 and heated sterile liquid produced by the machine in the respective basins.
17 In addition, several of the drapes and thermal treatment systems disclosed in the 18 above-mentioned patents and copending application include specialized features to enhance 19 various aspects of thermal treatment system operation. For example, some of the specialized features may include: bladder drapes (e.g., as disclosed in U.S. Patent Nos.
5,809,788;
21 5,950,438; and 6,003,328); drapes having plates or disks (e.g., as disclosed in U.S. Patent 22 Nos. 5,457,962 and 5,502,980); reinforced drapes (e.g., as disclosed in U.S. Patent No.
23 5,857,467); drape indicators and corresponding thermal treatment system detection devices 24 to ensure sterility by enabling system operation in response to detecting a sterile drape placed on the system (e.g., as disclosed in U.S. Patent Nos. 5,653,938 and 5,879,621); drapes having 26 indicia to direct placement of the drapes on thermal treatment systems (e.g., as disclosed in 27 U.S. Patent No. 5,615,423); surgical drapes constructed of materials having a coefficient of 28 friction in a particular range and/or drapes including attachment mechanisms such that a drape 29 may withstand being drawn under a dislodgment mechanism (e.g., as disclosed in U.S. Patent No. 6,035,855); a stand to elevate objects within a heated basin above the basin floor (e.g., 31 as disclosed in U.S. Patent No. 6,087,636) and/or a heater configured to cover a portion of the 1 basin (e.g., as disclosed in U.S. Patent Nos. 6,091,058 and 6,255,627) to prevent the drape 2 from overheating and puncturing when obj ects are placed within the basin;
and remote control 3 of a thermal treatment system (e.g., as disclosed in U.S. Patent Application Serial No.
4 09/572,903).
However, when insignificant amounts of liquid are present within a thermal treatment 6 system basin, the system heating and cooling mechanisms operate with minimal thermal 7 resistance, thereby enabling the mechanisms to become damaged. Further, the drapes 8 employed by the system may be damaged by being disposed proximate the heating or cooling 9 mechanism without having the liquid to absorb the thermal energy. Since only sterile drapes are to be used during surgical procedures, a leak in a surgical drape compromises sterility and 11 contaminates the entire surgical procedure, thereby increasing the risk of injury to a patient.
12 The related art has attempted to overcome this problem by employing sensing devices 13 with surgical drapes. For example, U.S. Patent No. 5,524,643 (Faries, Jr.
et al) discloses a 14 surgical drape combined with a sensor, preferably attached to the drape, to detect the presence of liquid within a drape container conforming to a heating/cooling thermal treatment system 16 basin. An alternative embodiment employs sensors at opposite surfaces of the drape to 17 measure conductance and, thereby, leakage through the drape. A
microprocessor of each 18 embodiment receives a signal representing, for example, an electrical conductance 19 measurement and determines the presence of liquid and/or a leak. If liquid is not present or a leak is determined to exist, the microprocessor disables a temperature controller for the 21 basin to prevent damage to the drape and heating and cooling mechanisms.
22 U.S. Patent No. 5,816,252 (Faries, Jr. et al) discloses a drape for use with a system for 23 thermally treating a sterile medium. The drape includes liquid sensitive material that changes 24 color upon contact with liquid to indicate the presence of a leak. The liquid sensitive material may be placed between the drape and a receiving basin or affixed to the drape in the form of 26 indicia symbolically directing placement of the drape over the system. The system may 27 include a single basin and be of the type that either thermally cools or heats the sterile 28 medium, or the system may include a plurality of basins with each basin either thermally 29 cooling or heating the sterile medium. The liquid sensitive material detects leaks within the drape while assisting the operator in properly aligning and placing the drape over the system.

1 U.S. PatentNo. 6,102,044 (Naidyhorski) discloses an electrode carrying surgical drape 2 including a polymeric film having opposing surfaces and an electrode receiving aperture 3 therethrough. An electrode is disposed through the aperture, while patches sealingly affix 4 electrode portions to each of the opposing surfaces of the polymeric film in the vicinity of the aperture to form a reinforced laminated structure capable of maintaining the sterility of an 6 established sterile field.
7 The above-described systems can stand some improvement. In particular, the Faries, 8 Jr. et al sensor drape (U.S. Patent No. 5,524,643) employs a plug connector disposed through 9 the drape to facilitate connections between the drape sensor and the thermal treatment system, thereby complicating the process of effectively sealing the drape to prevent contamination of 11 the sterile field. Further, the drape is required to be placed on the system with the plug 12 aligned with a corresponding plug receptacle for system operation, thereby restricting the 13 manners in which the drape may be positioned on the system to form the drape container. The 14 Faries, Jr. et al system employing liquid sensitive material with a drape (U.S. Patent No.
5,816,252) indicates the presence of a leak within the drape container.
However, this system 16 relies on operating room personnel to respond to the leak indication and perform appropriate 17 actions with respect to system operation. Thus, the system may continually operate in the 18 presence of a drape container leak until persomzel notice and respond to the leak indication, 19 thereby increasing the risk of contamination of a surgical procedure and damage to the system heating or cooling mechanism when a drape leak occurs. The Naidyhorski drape utilizes a 21 plurality of patches to sealingly affix the electrode to the drape, thereby increasing system 22 materials, complexity and costs. Moreover, the Naidyhorski electrode primarily serves as a 23 conduit or path through the drape and typically requires additional components to perform 24 sensing functions, thereby increasing costs and complexity of employing that drape with sensing functions.

27 Accordingly, it is an object of the present invention to detect the presence of solution 28 and/or a leak within a drape container disposed in a thermal treatment system basin and 29 control system operation in accordance with detected drape container conditions.
It is another object of the present invention to dispose a conductor or other object 31 through a sterile surgical drape while maintaining the sterile field.

1 Yet another object of the present invention is to employ a surgical drape including 2 solution and/or leak sensors with a thermal treatment system including circuitrythat interfaces 3 the drape to control system operation in accordance with drape conditions detected by the 4 sensors and circuitry.
The aforesaid objects may be achieved individually and/or in combination, and it is 6 not intended that the present invention be construed as requiring two or more of the obj ects 7 to be combined unless expressly required by the claims attached hereto.
8 According to the present invention, a drape including a sensing device is disposed 9 over a top surface of a thermal treatment system having a basin recessed therein. A portion of the drape is pushed down into, and conforms to, the basin to form a drape container or 11 receptacle within the basin for collecting a sterile medium. The thermal treatment system may 12 be of the type that either heats or congeals the sterile medium to respectivelyproduce a warm 13 sterile liquid or sterile slush within the basin. The sensing device is typically disposed through 14 the drape to provide a signal indicating the presence of liquid and/or leaks within the drape container to the system to facilitate control of system operation. In addition, the sensing 16 device may be affixed to a drape utilized for a multiple basin thermal treatment system 17 wherein each basin may either heat or congeal the sterile medium as described above. The 18 multiple basin drape forms a drape receptacle within each basin, while a sensing device is 19 typically disposed within each drape receptacle to detect the presence of liquid and/or a leak within that drape receptacle and provide a signal to the system to facilitate control of system 21 operation in substantially the same manner described above.
22 The above and further objects, features and advantages of the present invention will 23 become apparent upon consideration of the following detailed description of specific 24 embodiments thereof, particularly when taken in conjunction with the accompanying drawings, wherein like reference numerals in the various figures are utilized to designate like 26 components.

28 Fig. 1 is a view in perspective of a surgical drape including a sensing device and 29 disposed over a thermal treatment system according to the present invention.
Fig. 2 is a view in perspective of the surgical drape of Fig. 1 according to the present 31 invention.

1 Fig. 3 is a view in perspective of an alternative surgical drape including a sensing 2 device according to the present invention.
3 Fig. 4 is a view in elevation and partial section of a basin portion of the thermal 4 treatment system of Fig. 1 with the drape placed thereon.
Fig. 5 is an exploded top view of the thermal treatment system of Fig. 1 illustrating 6 system electrical connections.
7 Fig. 6 is an exploded top view of the thermal treatment system of Fig. 1 illustrating 8 an alternative arrangement for system electrical connections.
9 Fig. 7 is an electrical schematic diagram of control circuitry of the thermal treatment system of Fig. 1.
11 Fig. 8 is a schematic block diagram of a condition circuit for determining the presence 12 of liquid and/or leaks within a drape container.
13 Figs. 9A-9B are detailed electrical schematic diagrams of the condition circuit of Fig.
14 8.
Fig. 10 is an exploded view of a surgical drape including plural sensing devices and 16 disposed over a plural basin thermal treatment system according to the present invention.
17 Fig. 11° is an exploded view in perspective of an alternative surgical drape including 18 a sensing device and disposed over a thermal treatment system according to the present 19 invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
21 A thermal treatment system and corresponding drape according to the present 22 invention for heating a sterile medium (e.g., solution or liquid) and for detecting the presence 23 of the medium and leaks within a drape container is illustrated in Fig. 1.
Specifically, the 24 system includes a cabinet or housing 31, a wiring housing 44 attached to the cabinet and a warming basin 33 recessed into a cabinet top surface 34. Basin 33 may be of any shape, 26 however, by way of example only, the basin is illustrated as being substantially rectangular.
27 A heater power switch 37 and a temperature controller/indicator 38 are provided on top 28 surface 34 toward the cabinet front wall with the warming basin residing between the power 29 switch and controller. Wiring housing 44 is attached to the cabinet side wall that is closest to heater power switch 37 and facilitates system connections as described below. A heater 70 31 (Fig. 7) is disposed on the underside of the basin to heat the basin and the sterile medium 32 contained therein. The heater is controlled by controller 38 in accordance with an entered 1 desired temperature and temperatures measured by a temperature sensor 72 (Fig. 7) as 2 described below. Heater 70 is typically implemented by a conventional etched foil silicon 3 rubber heating pad and is attached to the basin underside via a pressure sensitive or other type 4 of adhesive. The heater may alternatively be of any quantity (e.g., at least one), shape or size, and may include any configuration (e.g., strips, bars, segments, etc.) that covers the entirety 6 or any portion of the basin. In addition, the heater may be implemented by any conventional 7 or other type of heater or heating element (e.g., heating coils, etc.) that may be disposed on 8 the basin at any suitable locations.
9 Temperature sensor 72 is preferably implemented by a conventional resistive temperature device (RTD) (e.g., a 1,000 Olnn RTD). However, the sensor may be 11 implemented by any conventional or other type of temperature sensor, and may be disposed 12 at any suitable location on the basin or within the cabinet. It is to be understood that the 13 thermal treatment system described above may have various configurations.
For example, the 14 thermal treatment system may be configured to cool and/or congeal the medium to produce cooled liquid or surgical slush. W this instance, the heater may be replaced by refrigeration 16 devices that are controlled in substantially the same manner described below in response to 17 detection of solution and leafs within the drape container. Further, the thermal treatment 18 system may include a plurality of basins warming and/or cooling a sterile medium as 19 described below. Examples of cooling and/or plural basin systems are disclosed in several of the above-mentioned Faries, Jr. et al. patents (e.g., 5,333,326; 5,429,801;
5,522,095;
21 5,524,643; 5,615,423; 5,653,938; 5,816,252; 5,862,672; 5,857,467;
5,879,621; 6,091,058; and 22 6,255,627).
23 A sterile drape 17, preferably transparent, is typically disposed over the top and sides 24 of cabinet 31 and made to conform to the side wall and bottom of basin 33.
Power switch 37 and controller 38 are disposed on top surface 34 of system cabinet 31 and are adjustable 26 manually through drape 17. The portion of drape 17 disposed in basin 33 serves as a sterile 27 container or receptacle for sterile liquid placed therein to be heated.
Typical sterile liquid 28 treated by the thermal treatment system is a 0.80% to 0.95% sodimn chloride solution (i.e., 29 saline). Drape 17 is made from a material that is impervious to the sterile liquid and sufficiently soft and flexible to conform to a basin wall. The thickness of the drape is 31 preferably minimized to render thermal transfer therethrough most efficient, yet the thickness 32 is sufficient to resist tearing and puncturing during normal use. The drape may be made of 1 materials commonly used in hospitals for surgical drapes and has a thickness, by way of 2 example only, of approximately five mils. However, the drape may have a thickness in the 3 approximate range of three through ten mils. Drape 17 may also be made of polyurethane 4 film as disclosed for the drape in U.S. Patent No. 4,934,152 (Templeton).
The drape may further include a preformed container portion contoured to match the contour of a basin. The 6 preformed container portion is typically thicker than the remaining portions of the drape 7 described above in order to resist puncture and enable the container portion to maintain the 8 shape of the basin. By way of example only, the container portion may be made of a heavy 9 gauge polyethylene/ionomer resin blend having a thiclcness of approximately ten through sixteen mils. The percentage of ionomer resin in the blend is in the approximate range of 11 forty to seventy percent. The drape is designed to be disposable after a single use and is 12 provided presterilized and prepackaged in a manner to preserve its sterile state during storage.
13 The drape is typically positioned over the thermal treatment system with a portion of 14 the drape disposed in a basin to form a drape receptacle as described above. The drape forms a sterile field above the basin to maintain sterility of the sterile medium.
However, a 16 puncture, tear or other opening in the drape disrupts the sterile field and may contaminate the 17 sterile liquid, thereby risking injury to a patient. Further, the thermal treatment system may 18 damage the drape (e.g., via the heating or refrigeration device) in the event that liquid is not 19 present within the drape container.
In order to detect the presence of liquid and/or leaks within the drape container to 21 maintain drape integrity and sterility of the sterile medium, drape 17 includes a sensing device 22 as illustrated in Fig. 2. Specifically, drape 17 is substantially rectangular and includes a 23 sensing device 20 to detect the presence of liquid and leaks within a drape container. Sensing 24 device 20 is in the form of a pair of electrodes 22, 24 that are affixed to a generally rectangular strip 25 disposed on an intermediate portion of the drape sterile surface. The electrodes are 26 disposed on the electrode strip toward respective strip longer dimensioned edges and extend 27 substantially in parallel. The electrode strip is enclosed within a pouch 26 to secure the 28 electrodes to the drape and to protect the electrodes from sharp obj ects that may be disposed 29 within the basin. In addition, the pouch assists to prevent grounding of the electrodes or formation of a current flow path therebetween due to placement of conductive objects (e.g., 31 instruments, stainless steel pitchers, etc.) in the basin that may produce erroneous detections 32 as described below. The pouch is formed from a substantially rectangular segment or flap 28 1 that is attached (e.g., welded) to the drape sterile surface and sealed by seams 30, each formed 2 toward and extending along a respective flap longer dimensioned edge. The distal ends of the 3 electrodes are attached to a plug or connector 40 that interfaces detection circuitry within the 4 thermal treatment system as described below. The plug includes electrode traces disposed on a plug top surface. The distal portions of strip 25 and electrodes 22, 24 pass through the 6 drape from the sterile to the non-sterile drape sides via an opening or slit 27 defined in the 7 drape at a location slightly offset from a drape central portion. A
substantially circular 8 segment or patch 42 is attached to the sterile drape surface to seal opening 27. The patch 9 basically encompasses opening 27 and effectively seals that opening to prevent escape of liquid from, and maintain sterility of, the drape container. Flap 28 and patch 42 are preferably 11 constructed of drape materials, however, the flap and patch maybe constructed of any suitable 12 materials, may be of any shape or size, and may be disposed on the drape at any suitable 13 locations via any conventional or other techniques.
14 Sensing device 20 detects the presence of liquid and leaks within the drape container in response to placement of drape 17 over the thermal treatment system. In particular, current 16 flow between the electrodes is initiated in response to the electrodes contacting liquid.
17 Further, the presence of a leak within the drape container enables current to flow between the 18 electrodes and ground (e.g., the basin beneath the drape). The current flow from each of these 19 conditions causes a respective change in voltage that is detected by detection circuitry within the thermal treatment system as described below. The magnitude of the voltage change is 21 utilized by the detection circuitry to detect the presence of solution and/or leaks within the 22 drape container and to control system operation in accordance with the detected conditions.
23 Wiring housing 44 (Fig. 1 ) receives signals from the electrodes and includes wiring to transfer 24 signals between that housing and the detection circuitry. The housing further includes indicators in the form of light emitting diodes to indicate drape container conditions. The 26 detection circuitry determines the drape container conditions based on the electrode signals 27 and controls system operation accordingly. In addition, the detection circuitry selectively 28 illuminates the diodes to indicate the particular determined drape container conditions as 29 described below.
In order to enable the liquid in the drape container to contact the electrodes and 31 facilitate current flow between those electrodes, flap 28 includes a series of slots 36. The slots 32 are defined in the flap between seams 30 and are spaced from each other in a direction of the 1 flap longer dimension. The slots are generally rectangular and extend substantially 2 perpendicular to electrodes 22, 24. Each slot includes a longer dimension substantially similar 3 to the width of strip 25 and encompasses portions of each electrode 22, 24 to facilitate 4 enhanced exposure of the electrodes to liquid within the drape container.
Alternatively, flap 28 may include a series of substantially circular openings 39 defined therein to permit contact 6 between the liquid and electrodes as illustrated in Fig. 3. Flap 28 may include any quantity 7 of slots or openings of any shape or size and disposed at any locations in ally desired fashion 8 to facilitate contact between the electrodes and liquid within the drape container.
9 Referring to Fig. 4, drape 17 is disposed over the thermal treatment system and within basin 33 to conform to the basin and form a drape container as described above. Electrodes 11 22, 24 are disposed on the sterile surface of the drape and pass through the drape to the non-12 sterile drape surface adjacent the basin bottom. The electrodes extend along basin walls 13 beneath the drape to wiring housing 44 attached to cabinet 31. The wiring housing includes 14 a receptacle 46 for receiving connector 40, thereby connecting the drape to detection circuitry disposed within the cabinet as described below. The wiring housing and/or receptacle may 16 alternatively be disposed at any location on cabinet 31 (e.g., top surface, side walls, cabinet 17 interior, etc.). The electrodes provide signals to the detection circuitry to facilitate detection 18 of liquid and/or leaks within the drape container.
19 The manner in which the detection circuitry and associated connections are facilitated within the cabinet is illustrated, by way of example only, in Fig. 5.
Specifically, the upper 21 portion of cabinet 31 includes the basin (not shown) and corresponding wiring. Wiring 22 housing 44 is mounted on a cabinet side wall toward the cabinet rear portion, while a power 23 cord 56 is disposed on that side wall toward a cabinet front portion.
Wiring housing 44 24 includes receptacle 46 and light-emitting diodes 47, 49, 51 that indicate drape container conditions. By way of example only, the wiring housing includes: green diode 47 to indicate 26 operation of the system (e.g., solution present without a drape container lealc); yellow diode 27 49 to indicate the absence of solution and leaks within the drape container; and red diode 51 28 to indicate the presence of a leak within the drape container. The detection circuitry basically 29 prevents system operation (e.g., disables controller 38) in response to a leak or the absence of liquid within the drape container, or in response to the absence of a connection between the 31 drape and the thermal treatment system. The wiring housing receives connector 40 within 32 receptacle 46 and facilitates connections via appropriate wiring between the receptacle, diodes 1 and a circuit board 52 of the detection circuitry containing a condition circuit as described 2 below. The wiring extends through housing 44 and the adjacent cabinet side wall to circuit 3 board 52. Fuses 48 are disposed in the cabinet side wall adjacent wiring housing 44. The 4 fuses protect the system circuitry from power surges and/or spikes that may cause damage to the system.
6 A generally rectangular base or plate 45 is disposed within the cabinet upper portion 7 above fuses 48. The top surface of the plate supports basin 33, while the underside of the 8 plate includes circuit board 52, a corresponding power supply 54 and a wiring harness 9 connector 50. The circuit board is connected to power supply 54, a corresponding fuse 48, diodes 47, 49, 51 and receptacle 46 via the wiring. Power conductors 58, 60 are connected 11 to power cord 56 and are associated with a ground 62 connected or grounded to the cabinet 12 upper portion and plate. Connector 50 is comlected to power conductors 58, 60, fuses 48, 13 power supply 54 and circuit board 52 to establish appropriate connections between the 14 components.
Alternatively, three fuses 48 may be employed in the system wiring as illustrated, by 16 way of example only, in Fig. 6. This arrangement is substantially similar to the arrangement 17 described above for Fig. 5 except that the alternative arrangement includes an additional fuse 18 48, and power conductors 58, 60 are each directly connected to a corresponding fuse.
19 Connector 50 is connected to the fuses, power supply and circuit board to establish appropriate connections, while the circuit board is further connected to power supply 54, a 21 corresponding fuse 48, diodes 47, 49, 51 and receptacle 46 via wiring as described above.
22 An exemplary control circuit for controlling system operation is illustrated in Fig. 7.
23 The control circuit is illustrated with respect to the wiring arrangement of Fig. 6, however, 24 any suitable wiring arrangement may be employed. Specifically, control circuit 100 includes heat control circuitry 110 and detection circuitry 120. Heat control circuitry 110 includes 26 connector 50, power switch 37, temperature controller 38, heater 70 and temperature sensor 27 72. Power plug or cord 56, preferably a hospital grade plug (e.g., 115V
AC), is connected to 28 a hospital outlet receptacle and to power conductors 58, 60 and ground 62.
Fuses 48 are 29 disposed in series with the respective power conductors between connector 50 and plug 56 to protect the system circuitry from damage as described above. Connector 50 is further 31 connected to power switch 37, controller 38 and connector plugs 74, 76 that interface 32 detection circuitry 120 as described below. An additional fuse 48 is disposed between plug 1 76 and connector 50 to protect the circuitry from power surges. The connector facilitates 2 appropriate connections between the circuitry components as described above.
3 Power switch 37 enables power to the system and is connected to controller 38. The 4 controller is further connected to heater 70 and temperature sensor 72 to control the heater in response to a desired or set point temperature entered by a user and the temperature measured 6 by the temperature sensor. In particular, controller 38 is typically implemented by a 7 conventional temperature controller and controls power to the heater based on a comparison 8 of the temperature measured by temperature sensor 72 and the set point temperature entered 9 by the user. When the measured temperature exceeds the set point temperature, controller 3 8 disables or reduces power to the heater. Conversely, when the measured temperature is below 11 the set point temperature, controller 38 enables or increases power to the heater. By way of 12 example only, controller 38 may be implemented by a 16A Series or a 1600 Series 13 Temperature/Process controls available from Love Controls, a Division of Dwyer Instruments, 14 Incorporated. A thermostat 68 is disposed between the controller and heater and basically disables current to heater 70 in response to a temperature measurement exceeding a 16 temperature threshold. In other words, the thermostat disables the heater in response to 17 detection of excessive heater temperatures. The thermostat may be implemented by any 18 conventional switching type or limiting devices, such as a high limit thermostat, and may be 19 disposed at any suitable location within the cabinet.
Controller 3 8 further controls heater 70 in response to signals received from detection 21 circuitry 120. The detection circuitry detects the presence of solution and leaks within the 22 drape container and provides appropriate signals to heat control circuitry 110 via plug 76. The 23 heat control circuitry disables the heater in response to the absence of solution within the 24 drape container and/or a drape container leak as indicated by the detection circuitry signals.
The detection circuitry includes circuit board 52 including a condition circuit 53 (Fig.
26 8), power supply 54 and diodes 47, 49, 51 indicating the drape container conditions. The 27 circuit board includes a series of pins or terminals 1-12 to facilitate connections, a plurality 28 of indicator lights 79 and a plug receptacle 80 for receiving plug 76 of heat control circuitry 29 110. By way of example only, pins 1 and 2 are connected to the wiring housing receptacle or connector 46 to receive electrode signals, while pins 9 and 11 are connected to the positive 31 and reference terminals of power supply 54, respectively. Pins 6 - 8 are connected to pin 9 32 and provide a voltage (e.g, +12V DC) to the condition circuit, while pin 12 is connected to 1 pin 11 and provides a ground. Green diode 47 is connected between pins 3 and 6 and is 2 illuminated in response to detection of solution within the drape container without a leak, 3 while yellow diode 49 is connected between pins 4 and 7 and is illuminated in response to 4 detection of the absence of solution and a leak within the drape container.
Red diode 51 is connected between pins 5 and 8 and is illuminated in response to detection of a leak within 6 the drape container. Pin 10 is basically inoperable and utilized to facilitate compatible 7 comlections with the board. Power supply 54 includes a plug receptacle 82 to receive plug 8 74 of heat control circuitry 110, thereby providing power signals from power plug 56 to the 9 power supply.
An exemplary condition circuit for detecting the presence of solution and leaks within 11 the drape container is illustrated in Figs. 8, 9A and 9B. Initially, the condition circuit prevents 12 operation of the thermal treatment system in the event a drape is damaged (e.g., contains a 13 leak) or not connected to the detection circuitry, or in the event solution is absent from the 14 drape container. The condition circuit is coupled to the drape electrodes via pins 1 and 2 of circuit board 52. The presence of solution within the drape container causes current flow 16 between the electrodes, while a leak facilitates current flow between the electrodes and ground 17 as described above. Accordingly, the current flow causes a voltage change at pins 1 and 2 of 18 the circuit board, thereby enabling detection of solution and leaks by the condition circuit.
19 In particular, the condition circuit includes comparators 84, 86, logic circuitry 88, 90, inverters 92, 94, a power switch 96 and an oscillator 98. Pin 1 of circuit board 52 is connected to the 21 non-inverting input of comparator 84, while that input is further connected to a resistor 91 22 (e.g., 180K Ohm) disposed in series with a supply voltage (e.g., 12V DC).
The non-inverting 23 input of comparator 84 is further coupled to additional circuitry (Fig. 9B) (e.g., a resistor 106 24 (e.g., 6.8K Ohm) connected in series with pin 1, a resistor 108 (e.g., l OK
Ohm) coupled to resistor 91 and the supply voltage, a diode 104 connected in parallel with resistor 91, and a 26 capacitor 102 (e.g., 1.5 ~,f) connected in parallel with resistor 91 and diode 104) to protect the 27 circuit from damage in the event an external voltage is applied to pins 1 and 2 and to provide 28 filtering to prevent a response to noise. A diode 95 is disposed in a feedback path of 29 comparator 84 to maintain the state of a particular condition as described below. The inverting input of comparator 84 is similarly coupled to additional circuitry (Fig. 9B) (e.g., 31 a resistor 112 (e.g., 6.8K Ohm) connected between resistor 108 and a gromid potential, and 32 a capacitor 114 (e.g., .1 ~f) connected in parallel with resistor 112) to enhance circuit 1 performance. Resistors 108 and 112 basically provide the comparator inverting input with 2 a reference voltage (e.g., SV DC). Comparator 84 determines the presence of a drape 3 container leak by comparing the input of pin 1 to the reference voltage (e.g., SV DC). If pin 4 1 exceeds the reference voltage, the comparator provides a high level logic signal indicating the absence of a leak (e.g., the signal LEAK in the figures indicates the absence of a drape 6 container leak when attaiung a high logic level); otherwise a low level logic signal indicating 7 the presence of a leak is produced by the comparator.
8 Pin 2 is connected to the inverting input of comparator 86, while that input is further 9 connected to a resistor 93 (e.g., 270K Ohm) disposed between the comparator input and a ground potential. The inverting input is further coupled to additional circuitry (Fig. 9A) (e.g., 11 a resistor 124 (e.g., 6.8K Ohm) connected in series with pin 2, a diode 116 connected in series 12 with a supply voltage (e.g., 12V DC), a diode 118 connected in parallel with resistor 93, and 13 a capacitor 122 (e.g., .68 ~,fJ connected in parallel with resistor 93 and diode 118) to protect 14 the circuit fiom damage in the event an external voltage is applied to pins 1 and 2 and to provide filtering to prevent a response to noise. The non-inventing input of comparator 86 16 is coupled to additional circuitry (Fig. 9A) (e.g., a resistor 126 (e.g., 270K Ohm) coimected 17 in a comparator feedback path, a resistor 128 (e.g, 27K Ohm) connected between the non-18 inverting input and a supply voltage (e.g.,12V DC), a resistor 130 (e.g., 6.8K Ohm) connected 19 between the non-inverting input and a ground potential, and a resistor 132 (e.g., lOK Ohm) connected between a supply voltage (e.g.,12V DC) and the comparator output) that basically 21 provides a reference voltage (e.g., 2.SV DC) for the comparator non-inverting input.
22 Comparator 86 determines the presence of solution within the drape container by comparing 23 the input of pin 2 with the reference voltage. If pin 2 exceeds the reference voltage (e.g., 24 2.SV), the comparator produces a high level logic signal indicating the absence of solution within the drape container (e.g., the signal SOL in the figures indicates the absence of 26 solution within the drape container when attaining a lugh logic level);
otherwise a low level 27 logic signal indicating the presence of solution is produced.
28 The output of comparator 84 is coupled to inverter 94, to an input of logic circuitry 88 29 and to an input of logic circuitry 90. The comparator output is fiuther coupled to additional circuitry (Fig. 9B) (e.g., a resistor 134 (e.g., lOK Ohm) connected between the comparator 31 output and a supply voltage (e.g., 12V DC)) to enhance circuit performance.
Inverter 94 is 1 in the form of a NAND gate (Fig. 9B) and inverts the comparator output.
Since comparator 2 84 provides a low level logic signal in response to the presence of a leak as described above, 3 inverter 94 inverts the comparator output to provide a high level logic signal in response to 4 a leak (e.g., the signal LEA in the figures indicates the presence of a drape container leak when attaining a lugh logic level). The inverter is connected to a timer 98 that serves as a low 6 frequency oscillator and is actuated by the high level logic signal produced by inverter 94 in 7 response to the presence of a leak. Additional circuitry (Fig. 9B) (e.g., a resistor 136 (e.g., 8 1.SM Ohrn) connected in series with the NAND gate output, a resistor 138 (e.g., 270 I~ Ohm) 9 comlected between timer inputs, a capacitor 140 (e.g.,1.5 ~,f) connected between resistor 13 8 and a ground potential, and a capacitor 142 (e.g., .1 ~.f) connected between a timer input and 11 the ground potential) is connected to and/or between the inverter and oscillator to enhance 12 actuation of the oscillator in response to a high level logic signal from the inverter. The 13 oscillator output is coupled to a reference terminal of a speaker 97 and to pin 5 for actuating 14 red diode 51. A resistor 143 (e.g., 1K Ohm) is disposed between pin 5 and the oscillator output, while a speakerpositive terminal is connected to a supply voltage (e.g.,12V DC). The 16 oscillator output is in the form of a pulse train that provides periodic low level logic signals.
17 The low level signals provide a sufficient voltage differential to enable the supply voltages 18 of the red diode (e.g., 12V DC of pin 8) and speaker (e.g., 12V DC of the speaker positive 19 terminal) to drive those devices. Thus, the oscillator produces a pulse train that enables the diode to flash and the speaker to beep at rates proportional to the pulse train frequency when 21 a leak is present in the drape container.
22 Conversely, when a leak is absent from the drape container, comparator 84 provides 23 a high level logic signal as described above. Inverter 94 inverts the comparator output to 24 provide a low level logic signal in response to the absence of a leak. The low level logic signal is insufficient to actuate oscillator 98, thereby disabling red diode 51 and speaker 97 26 when a leak is not present within the drape container.
27 Logic circuitry 88 determines the presence of conditions to enable the heater (e.g., 28 solution is present within the drape container without a leak). The logic circuitry is coupled 29 to outputs of comparators 84 and 86. An inverter 92 in the form of a NAND
gate (Fig. 9A) is disposed between logic circuitry 88 and comparator 86 to invert the comparator output.
31 Since comparator 86 produces a low level logic signal in response to the presence of solution 1 within the drape container, inverter 92 inverts the comparator output to provide a high level 2 logic signal in response to the presence of solution (e.g., the signal SOLwithin the figures 3 indicates the presence of solution within the drape container when attaining a high logic 4 level). Logic circuitry 88 combines the signals (e.g., LEAK, SOL) from comparator 84 and inverter 92, indicating leak and solution conditions, and provides a signal to illuminate green 6 diode 47 and actuate power switch circuitry 96 to enable heater 70 in response to the signals 7 indicating the presence of solution without a leak in the drape container.
8 Logic gate circuitry 88 (Fig. 9A) includes a NAND gate 144 and a comparator 146.
9 The NAND gate receives output signals from comparator 84 and inverter 92 and produces a low level logic signal in response to the signals indicating the presence of solution in the drape 11 container without a leak. The NAND gate output is connected to the non-inverting input of 12 comparator 146, while the comparator inverting input is connected to a reference voltage (e.g., 13 SV DC). The comparator produces a low level logic signal in response to a low NAND gate 14 output in order to drive power switch circuitry 96 to enable heater 70 when solution is present within the drape container without a leak. NAND gate 144 is further coupled to additional 16 circuitry (e.g., a ground potential coupled to a gate terminal, a supply voltage (e.g., 12V DC) 17 coupled to another gate terminal with a capacitor 148 (e.g., .1 ~,f) connected between that gate 18 terminal and a ground potential) to enhance gate operation.
19 Power switch circuitry 96 includes an optocoupler 150 and a triac 154. The triac is connected between conductors 160, 162 of plug 76 and has a gate terminal coupled to an 21 output of the optocoupler. An optocoupler input is coupled to circuit board pin 3 and, hence, 22 to green diode 47 disposed between circuit board pins 3 and 6, while a resistor 158 (e.g., 1K
23 Ohm) is connected between pin 3 and the optocoupler. The output of comparator 146 24 indicating drape container conditions is connected to another input of the optocoupler to drive the power switch circuitry in response to the presence of solution without a leak in the drape 26 container as described above. A resistor 152 (e.g., 22 Ohms) is connected to an optocoupler 27 output and in series with the triac, while a resistor 156 (e.g., 1 K Ohm) is connected between 28 the triac gate terminal and conductor 162 of plug 76. A low level logic signal produced by 29 comparator 146 provides a ground that enables the optocoupler input to receive appropriate current to produce outputs that drive the triac. Thus, the low level logic signal from 31 comparator 146 enables actuation of the green diode and triac to indicate the presence of 1 solution without a leak in the drape container and to enable the heater, respectively. The triac 2 provides signals to heat control circuitry 110 (Fig. 7) via plug 76 to control actuation of the 3 heater as described above.
4 Conversely, when a leak is present within, or solution is absent from, the drape container, comparators 84, 86 provide signals that enable NAND gate 144 to produce a high 6 level logic signal. Comparator 146 generates a high level logic signal in response to the high 7 level NAND gate output, therebypreventing actuation ofpower switch 96, green diode 47 and 8 heater 70 when a leak is present within, or solution is absent from, the drape conatiner.
9 Logic circuitry 90 determines the presence of conditions to illuminate yellow diode 49 (e.g., neither solution nor a leak is present within the drape container).
The logic circuitry 11 is coupled to the outputs of comparators 84 and 86. Logic circuitry 90 combines the signals 12 (e.g., LEAK, SOL ) from comparators 84, 86 indicating drape container conditions and 13 provides a signal to actuate yellow diode 49 in response to the comparator signals indicating 14 the absence of solution and a leak within the drape container.
Logic circuitry 90 (Fig. 9A) includes a NAND gate 164 and a comparator 166.
The 16 NAND gate receives output signals from comparators 84 and 86 and produces a low level 17 logic signal in response to the comparator signals indicating the absence of solution and a leak 18 within the drape container. The NAND gate output is comlected to the non-inverting input of 19 comparator 166, while the comparator inverting input is connected to a reference voltage (e.g., SV DC). The comparator provides a low level logic signal in response to a low NAND gate 21 output in order to illuminate yellow diode 49. The yellow diode is disposed between circuit 22 board pins 4 and 7 with a resistor 170 (e.g., 1K Ohm) connected between pin 4 and the 23 comparator output. A low level logic signal produced by comparator 166 provides a sufficient 24 voltage differential to enable pin 7 connected to a supply voltage (e.g.,12V DC) to illuminate yellow diode 49. Conversely, when a leak or solution is present within the drape container, 26 comparators 84, 86 provide signals that enable NAND gate 164 to produce a high level logic 27 signal. Comparator 166 generates a high level logic signal in response to the high level 28 NAND gate output, thereby preventing illumination of yellow diode 49 when a leak or 29 solution is present within the drape container.
The condition circuit basically controls system operation in response to detected drape 31 container conditions. The circuit is arranged to enable signals from comparators 84, 86 to 1 selectively facilitate a particular action (e.g., illuminate the red diode and speaker, enable the 2 green diode and heater, or illuminate the yellow diode) in response to the occurrence of 3 corresponding conditions for that action. In other words, a particular action is initiated by the 4 condition circuit in response to the occurrence of corresponding conditions, while remaining actions are disabled. Thus, the green diode and heater are enabled by the condition circuit in 6 response to the presence of solution without a leak in the drape container, and are disabled 7 during occurrence of other drape container conditions (e.g., a leak or no solution within the 8 drape container). Enablement and disablement of the yellow diode and red diode and speaker 9 are facilitated in a similar manner with respect to their corresponding conditions. The condition circuit and/or circuit board may further include circuitry to record the time and/or 11 date when the system or heater is enabled and disabled or any other information. The stored 12 information may be retrieved for hospital records or to assist in evaluating system 13 performance.
14 The manner in which the condition circuit operates is described, by way of example only, with reference to Fig. 8. Initially, when solution is absent from the drape container, no 16 current flow exists between electrodes 22, 24 (Fig. 2) and the voltage applied to pins 1 and 17 2 of circuit board 52 is maintained at twelve and zero volts, respectively.
These conditions are 18 similarly present when the drape is disconnected from or incompatible with the system. The 19 output of comparators 84 and 86 are high (e.g., indicating no leak and no solution), thereby enabling logic circuitry 90 to illuminate yellow diode 49 as described above, while the heater, 21 speaker and green and red diodes are disabled as described above.
22 W the event that solution is present without a leak in the drape container, a conductive 23 path is formed between the electrodes and, hence, between pins 1 and 2 of the circuit board.
24 Since the conductive path has a low resistance relative to resistors 91 and 93, these resistors basically form a voltage divider with resistor 91 connected to the supply voltage of 12V DC
26 and resistor 93 connected to ground. The voltage divider provides each pin 1 and 2 with 27 approximately 7.2 V DC. Accordingly, the output of comparator 84 is high (e.g., indicating 28 no leak), while the output of comparator 86 is low (e.g., indicating the presence of solution), 29 thereby enabling logic circuitry 88 to illuminate the green diode and actuate the power switch to enable the heater, while the speaker and red and yellow diodes are disabled as described 31 above.

1 A leak within the drape container forms a conductive path between the electrodes (e.g., 2 and, hence, pins 1 and 2) and ground. Thus, the potential of pin 1 is reduced below the 3 comparator reference potential (e.g., SV DC), thereby causing comparator 84 to produce a low 4 level logic signal. Diode 95 provides feedback to maintain the state of the leak condition until power is disabled. The low output of comparator 84 is inverted by inverter 94, thereby 6 actuating oscillator 98. The oscillator illuminates red diode 51 and actuates speaker 97 to 7 provide an audio leak indication, while the heater and green and yellow diodes are disabled 8 as described above. The output of comparator 86 has no bearing on leak detection and is 9 ignored with respect to actuation of the oscillator. The condition circuit basically generates signals to control the heater and provides visual and audio indications to inform a user of the 11 drape container status.
12 The condition circuitry may employ any conventional or other components that 13 perform the above-described functions. The reference voltages utilized by comparators 84, 14 86 to detect drape container conditions may be any suitable voltages. By way of example only, the reference voltages utilized by those comparators in the condition circuit are derived 16 from properties of saline or salt-water type solutions. Further, the reference voltages may be 17 adjusted to account for objects placed in the basin. For example, placement of conductive 18 objects (e.g., instruments, stainless steel pitchers, etc.) within the basin may establish a path 19 for current flow between the electrodes irrespective of the presence of solution, thereby enabling the condition circuit to indicate erroneous conditions. Accordingly, the reference 21 voltages may be adjusted to differentiate between current flow initiated by solution and the 22 current flow initiated by a conductive object. Alternatively, conductive objects may be 23 utilized in combination with and placed on a stand disposed within the basin to elevate the 24 objects above the electrodes and basin floor in a manner similar to that disclosed in U.S.
Patent No. 6,087,636.
26 Operation of the thermal treatment system is described with reference to Figs. 1, 4, 7 27 and 8. Initially, drape 17 is placed over the top surface of the thermal treatment system and 28 disposed in basin 33 to form a drape receptacle. Connector 40 of the drape is inserted within 29 receptacle 46 of wiring housing 44 to connect the drape to detection circuitry 120 to facilitate detection of drape container conditions. Power switch 37 is actuated and detection circuitry 31 120 senses no voltage change across the electrodes (e.g., and, hence, pins 1 and 2 of the circuit 32 board), thereby indicating the absence of solution and a leak within the drape container as 1 described above. The detection circuitry illuminates yellow diode 49, while disabling the 2 heater, speaker and red and green diodes as described above. A sterile medium is disposed 3 within the drape receptacle and a desired temperature for the medium is entered into the 4 system by the user via controller 38. The sterile medium forms a conductive path between the electrodes that affects the voltage thereof (e.g., and, hence, of pins 1 and 2 of the circuit 6 board). Detection circuitry 120 senses the voltage change indicating the presence of solution 7 without a leak in the drape container, and illuminates green diode 47 and enables actuation 8 of the heater, while disabling the speaker and red and yellow diodes as described above.
9 Temperature controller 38 subsequently controls power to heater 70 in accordance with a comparison of the desired temperature with a temperature measured by temperature sensor 11 72 as described above.
12 When a leak occurs within the drape container, a conductive path is formed between 13 the electrodes and the basin serving as ground, thereby affecting the voltage of the electrodes 14 (e.g., and, hence, of pins 1 and 2 of the circuit board). The detection circuitry senses the voltage change indicating a leak within the drape container, and provides an audio indication 16 via speaker 97, flashes red diode 51 and disables the heater and yellow and green diodes as 17 described above.
18 It is to be understood that the present invention maybe employed for thermal treatment 19 systems including a plurality of basins that either heat or cool the sterile medium. An exemplaryplural basin system and corresponding drape according to the present invention are 21 illustrated in Fig. 10. Specifically, the plural basin system includes an integral assembly 190 22 including warming basin 33 and a substantially circular cooling basin 182 to thermally treat 23 sterile liquid. The system includes power switches 37, 186 and controllers 38, 187 to control 24 operation of the warming and cooling basins, respectively. The assembly further houses the heating and refrigeration devices and control circuitry (not shown) for the individual basins 26 to thermally treat those basins and liquid contained therein as described above. A drape 188, 27 substantially similar to drape 17 described above, is placed over the system and within each 28 basin to form a drape receptacle therein as described above. Sensing devices 20 are affixed 29 at appropriate locations on the drape in the manner described above for insertion within a corresponding basin to detect drape container conditions within that basin.
Electrode signals 31 are conveyed from each sensing device disposed within a basin to a corresponding individual 32 condition circuit associated with that basin to determine drape container conditions and 1 provide signals to control the basin in substantially the same manner described above. The 2 assembly may further include a wiring housing 44 associated with each basin to receive 3 connector 40 of the associated sensing device and transfer signals between that housing and 4 a corresponding individual condition circuit in substantiallythe same manner described above.
Each wiring housing typically includes diodes 47, 49, 51 to indicate drape container 6 conditions within a corresponding basin and a receptacle 46 to receive a corresponding 7 connector 40 as described above. The individual basins each basically function in 8 substantially the same manner as the single basin system described above, where the plural 9 basins may be individually controlled or collectively controlled (e.g., all basins enabled or disabled) in response to drape container conditions.
11 In addition, the sensing device electrodes may alternatively traverse a drape edge to 12 extend between the sterile and non-sterile drape surfaces and interface detection circuitry 13 disposed within the cabinet as illustrated in Fig. 11. hutially, the thermal treatment system 14 and drape are substantially similar to the system and drape described above for Fig. 1, except that sensing device 20 traverses a drape bottom edge (e.g., without being disposed through the 16 drape) to extend between sterile and non-sterile drape surfaces.
Specifically, the thermal 17 treatment system includes cabinet 31, wiring housing 44, power switch 37, controller 38 and 18 warming basin 33 recessed into cabinet top surface 34, each as described above. Drape 17 is 19 typically positioned over the thermal treatment system with a portion of the drape disposed in basin 33 to form a drape receptacle as described above. The drape forms a sterile field 21 above the basin to maintain sterility of the sterile medium. Drape 17 includes sensing device 22 20 to detect the presence of liquid and leaks within the drape container.
Sensing device 20 23 is in the form of a pair of electrodes 22, 24 that are affixed to strip 25 with the strip proximal 24 portion secured to an intermediate section of the drape sterile surface (e.g., the strip proximal portion may be disposed within pouch 26). The distal ends of the electrodes are attached to 26 plug 40 that interfaces detection circuitry within the thermal treatment system as described 27 above. Strip 25 extends from the drape container along the drape sterile surface covering the 28 basin and cabinet walls to a drape bottom or peripheral edge. The strip traverses the drape 29 bottom edge to pass from the sterile to the non-sterile drape surface, and further extends beneath the drape to wiring housing 44 attached to cabinet 31. The wiring housing includes 31 receptacle 46 for receiving connector 40, thereby connecting the drape to detection circuitry 32 disposed within the thermal treatment system as described above. The electrodes provide 1 signals to the detection circuitry to facilitate detection of liquid and/or leaks within the drape 2 container as described above. Further, the sensing devices of plural basin drape 188 may be 3 fastened to that drape with respective electrode strips traversing a drape edge (e.g., without 4 being disposed through the drape) to extend between the sterile and non-sterile drape surfaces for connection to corresponding detection circuitry disposed within the plural basin system 6 in substantially the same manner described above.
7 It will be appreciated that the embodiments described above and illustrated in the 8 drawings represent only a few of the many ways of implementing a medical solution thermal 9 treatment system and method of controlling system operation in accordance with detection of solution and leaks in surgical drape containers.
11 The warming, cooling and plural basin systems and their corresponding cabinets, 12 assemblies or housings may be of any shape or size and may be constructed of any suitable 13 materials. The plural basin system may include any quantity of heating and/or cooling basins 14 in any combinations. The basins of the systems may be of any shape or size, may be constructed of any suitable thermal conducting materials (e.g., stainless steel) and may be 16 disposed at any suitable locations on or within the housings. The systems may include any 17 conventional or other heating and/or refrigeration units to thermally treat the sterile medium 18 or other substance to any desired temperature. The heating unit may include any conventional 19 or other heating device and components to control heating of a basin to any desired temperature (e.g., preferablyto temperatures near (e.g., above, at orbelow) body temperature, 21 such as temperatures in the approximate range of 60° F - 160°
F). The heater may be of any 22 quantity (e.g., at least one), shape or size, and may include any configuration (e.g., strips, bars, 23 segments, etc.) that covers the entirety or any portion of a basin. The heater may be attached 24 to a basin via any conventional or other fastening techniques (e.g., any type of adhesives, brackets, etc.). In addition, the heater may be implemented by any conventional or other type 26 of heater or heating element (e.g., heating coils, etc.) that may be disposed on or proximate 27 a basin at any suitable locations.
28 The cooling unit may include any conventional or other cooling or refrigeration device 29 and components to control cooling of a basin to any desired temperature (e.g., preferably to temperatures near or below the freezing temperature of the sterile liquid or medium, such as 31 temperatures in the approximate range of -32° F to 32° F).
The various power switches and 1 controllers of the systems may be implemented by any conventional or other power and 2 control devices and may be disposed on the systems at any suitable locations.
3 The temperature sensor maybe implemented by any conventional or other temperature 4 sensing device (e.g., infrared, RTD, etc.) and maybe disposed at any location on orproximate a basin or within the systems. The basins of the systems may be disposed in any arrangement 6 or at any suitable locations on the systems. The systems may thermally treat (e.g., heat or 7 cool) any type of medium or liquid, while a cooling basin may further include any type of 8 conventional or other dislodgement mechanism, such as those described in the aforementioned 9 patents.
The wiring housing may be of any quantity, shape or size, may be constructed of any 11 suitable materials, and may be disposed at any suitable locations on the systems. The wiring 12 housing and/or systems may include any suitable conductors or other medium (e.g., wireless, 13 fiberoptics, etc.) to transfer signals between system components. The wiring housing may 14 include any type of receptacle disposed at any suitable location on the wiring housing or systems to interface the drape sensing device. The wiring housing may include any quantity 16 of any type of indicator (e.g., audio, speech synthesis, LED, display screen with text or 17 images, etc.) to indicate the drape container status. The indicator may be disposed on the 18 wiring housing or systems at any suitable locations. The diodes may be of any quantity or 19 color, may be disposed at any suitable locations on the wiring housing or systems and may be illuminated in any desired fashion or pattern (e.g., flashing, continuous illumination, etc.).
21 A drape container or other condition may be associated with any quantity of any diodes of any 22 color (e.g., the same or different colors in any desired combinations).
23 The drapes employed with the heating, cooling and plural basin systems may be of any 24 size or shape, and may be constructed of any suitable materials. The drapes are preferably transparent or translucent to facilitate manipulation of controls through the drape, however, 26 these drapes may have any degree of transparency (e.g., including opaque).
The drapes may 27 be manipulated in any fashion with any portions of the drapes serving as a drape receptacle 28 within a corresponding basin. The drapes may be of sufficient size to accommodate and form 29 drape receptacles within any quantity of thermal treatment system basins.
The sensing device may include any quantity of electrodes or electrode strips disposed 31 at any suitable locations on a drape. The electrodes may be constructed of any suitable 32 conductive materials. The electrode strip maybe of any shape or size, and maybe constructed 1 of any suitable materials. The electrodes maybe fastened to the strip at any suitable locations 2 via any conventional or other fastening techniques. The pouch may be of any quantity, shape 3 or size, may be constructed of any suitable materials, may contain any portions of the 4 electrodes or electrode strip and may be fastened to the drape at any suitable locations via any conventional or other fastening techniques. The flap may be of any quantity, shape or size, 6 may be attached to the drape at any suitable locations via any conventional or other fastening 7 techniques to form the pouch and may be constructed of any suitable materials. The seams 8 may be disposed on the flap at any suitable locations to attach the flap to the drape to form the 9 pouch. The flap rnay include any quantity of openings or slots of any shape or size disposed in any suitable locations on the flap or pouch and arranged in any fashion to enable liquid 11 within the drape container to contact the electrodes. Alternatively, the sensing device or 12 electrode strip maybe attached to the drape (i.e., without the pouch) via the patch or any other 13 securing mechanisms (e.g., adhesives, welding, etc.) to sense drape container conditions.
14 The drape opening may be of any quantity, shape or size and may be defined in the drape at any suitable locations. The patch may be of any quantity, shape or size, may be 16 constructed of any suitable materials and may be disposed at any suitable locations on the 17 drape. The drape may include any quantity of openings and corresponding patches disposed 18 on or attached to either or both of the sterile and non-sterile drape surfaces. The drape may 19 include any quantity of sensing devices for a corresponding basin where the sensing device signals may be combined in any fashion (e.g., at least one device detecting liquid, combined 21 logically (e.g., AND, OR, etc.), etc.) to determine occurrence of drape container conditions 22 (e.g., solution or leaks present). The sensing device plug may be implemented by any 23 conventional or other plug or connector where the electrode traces may be disposed at any 24 locations on the plug. Alternatively, the electrode strip or other objects may traverse a drape peripheral or other edge (e.g., without being disposed through the drape) to extend between 26 the sterile and non-sterile drape surfaces.
27 The electrical connections may include any quantity of components (e.g., power cord, 28 fuses, conductors, connectors, power supply, circuit board, diodes, etc.) arranged in any 29 desired fashion, where each component may be implemented by any conventional or other component performing the described function. The control circuit may be disposed within 31 the systems at any suitable locations and may be implemented by any conventional or other 32 circuitry components arranged in any desired fashion to perform the described functions. The 1 plugs comlecting thermal control circuitry to the detection circuitry may be implemented by 2 any conventional or other connectors for transfernng signals. The temperature controller may 3 be implemented by any conventional or other temperature controller and include any desired 4 devices for entering a temperature (e.g., buttons, keypad, etc.). The basin power switches of the systems may be implemented by any conventional or other switching device, while the 6 fuses may be implemented by any conventional fuse or other limiting device and may be 7 configured for any current or voltage levels. The wiring harness connector may be 8 implemented by any conventional or other connector to facilitate component connections, 9 while the power cord may be implemented by any conventional or other cord or cable and be configured to acconnnodate any desired power signals. The thermostat may be implemented 11 by any conventional switching type or limiting devices, such as a high limit thermostat, and 12 may be disposed at any suitable location within the systems.
13 The circuit board housing the condition circuit may include any quantity of terminals 14 or pins each associated with any desired signals or portion of the condition circuit. The circuit board may include any quantity of indicators disposed at any suitable locations to indicate the 16 occurrence or status of any desired circuit portion or condition. The circuit board receptacle 17 may be implemented by any conventional or other receptacle and be suitable for receiving any 18 type of plug or connector to interface thermal control circuitry. The power supply may be 19 implemented by any conventional or other power supply or source and provide any desired power signals, and may include any type of conventional or other receptacle for receiving any 21 type of plug or connector to interface thermal control circuitry. The diodes or other indicators 22 may be connected to the circuit board pins in any desired fashion. The circuit board may 23 house the condition circuit and/or any other desired system circuitry.
Further, the circuit 24 board may include devices to record any types of information relating to system operation for subsequent retrieval and analysis (e.g., date and time of thermal treatment disablement and 26 enablement, etc.).
27 The condition circuit may include any quantity of conventional or other components 28 arranged in any desired fashion to perform the functions described herein.
The circuit 29 comparators may be implemented by any conventional or other comparators or comparing devices and may utilize any suitable reference potentials to detect solution, leaks or any other 31 conditions. The inverters maybe implemented by any conventional or other inverting devices 32 (e.g., logic gates, circuitry, etc.) to invert circuit signals. The logic circuitry and 1 corresponding logic gates maybe implementedby anylogic gates or combinational logic (e.g., 2 AND, OR, NAND, NOR, XOR, etc.) and/or circuitry (e.g., comparator, inverter, transistors, 3 etc.) arranged in any desired fashion to combine signals to determine the occurrence of any 4 conditions. The logic circuitry comparators maybe implemented by any conventional or other compaxators or comparing devices and utilize any desired reference potentials.
The oscillator 6 may be implemented by any conventional or other timer or oscillating device producing 7 outputs at any desired frequency. The oscillator may drive any type of device (e.g., speaker, 8 speech synthesis, diode, etc.) to indicate the presence of a condition, while the indicator 9 devices may alternatively be driven by any type of circuitry or mechanism.
The speaker may be implemented by any conventional or other speaker or audio device and may provide any 11 suitable audio indication (e.g., beep at any suitable periodic interval, continuous audio output, 12 etc.).
13 The triac may be implemented by any conventional or other triac or relay type device 14 to provide signals to thermal control circuitry for controlling thermal treatment of a basin.
The condition circuit may include any additional circuitry (e.g., resistors, capacitors, 16 inductors, diodes, supply and ground potentials, etc.) arranged in any fashion and including 17 any desired electrical characteristic values (e.g., resistance, potential, capacitance, etc.) to 18 facilitate circuit operation. The condition circuit signals may include any desired logic or 19 voltage levels. The optocoupler may be implemented by any conventional or other optocoupler or other circuitry to control the triac to provide signals to the thermal control 21 circuitry.
22 The plural basin system may include individual thermal control and detection circuitry 23 associated with each basin to monitor drape container conditions and control basin operation.
24 Alternatively, the plural basin system may include common thermal control and detection circuitry to control each basin in response to drape container conditions. The common 26 circuitry may receive signals from each sensing device and control the basins individually or 27 collectively in response to the drape container conditions. The common circuitrymayprocess 28 and combine the signals in any fashion (e.g., AND, OR, etc.) to determine conditions for 29 controlling the basins. The detection circuitry of the systems may alternatively include a microprocessor to process electrode signals and control the diodes, heater, speaker or any 31 other devices. In this case, electrode signals are converted to digital signals and compared 32 by the microprocessor to threshold levels for each condition. The microprocessor may 1 generate the appropriate control signals to control basin thermal devices and various indicators 2 in accordance with the determined conditions.
3 The drape may facilitate placement of any types of obj ects (e.g., conductors, tubes or 4 other fluid passages, various communication medium, etc.) through or around the drape in any manner (e.g., traverse any drape opening or drape edge, etc.) to enable communication or 6 passage between the sterile and non-sterile sides of the drape without compromising the sterile 7 field. Further, the electrodes or other communication medium may be connected to various 8 sensors or any other types of measuring, analytical and/or control devices to measure, 9 determine andlor indicate any types of conditions and/or control system operation in any desired fashion in response thereto.
11 It is to be understood that the terms "top", "bottom", "front", "rear", "side", "height", 12 "length", "width", "upper", "lower" and the like are used herein merely to describe points of 13 reference and do not limit the present invention to any particular orientation or configuration.
14 From the foregoing description, it will be appreciated that the invention makes available a novel medical solution thermal treatment system and method of controlling system 16 operation in accordance with detection of solution and leaks in surgical drape containers 17 wherein a surgical drape includes a sensing device to provide signals indicating drape 18 container conditions to a thermal treatment system to facilitate control of system operation.
19 Having described preferred embodiments of a new and improved medical solution thermal treatment system and method of controlling system operation in accordance with 21 detection of solution and leaks in surgical drape containers, it is believed that other 22 modifications, variations and changes will be suggested to those skilled in the art in view of 23 the teachings set forth herein. It is therefore to be understood that all such variations, 24 modifications and changes are believed to fall within the scope of the present invention as defined by the appended claims.

Claims

What is Claimed is:

1. A system for detecting conditions within containers formed by surgical drapes during surgical procedures and controlling thermal treatment of said containers in response to said detected conditions, said system comprising:
a thermal treatment unit to thermally treat a liquid and including a basin;
a surgical drape, covering and substantially conforming to said basin, to serve as a drape container for said liquid;
a sensing device including a plurality of conductors each disposed on a sterile drape surface within said drape container and extending therefrom to a non-sterile drape surface, wherein potentials of said conductors are responsive to contact between said conductors and said liquid and indicate conditions of said drape container;
a controller to operate said thermal treatment unit to control a temperature of said basin; and a detection unit in communication with said sensing device to determine occurrence of said drape container conditions from said potentials of said conductors and to control said controller to operate said thermal treatment unit in accordance with said determined drape container conditions.

2. The system of claim 1 wherein said plurality of conductors includes a plurality of electrodes.

3. The system of claim 1 wherein said drape includes an opening defined therein to permit passage of said plurality of conductors therethrough and a material segment attached to a drape surface coincident said opening to seal said opening and secure said plurality of conductors within said drape container.

4. The system of claim 1 wherein said drape includes a receptacle attached to said sterile drape surface to contain a proximal portion of each said conductor, wherein said receptacle includes a series of openings defined therein to enable said liquid within said drape container to contact said plurality of conductors contained within said receptacle.

5. The system of claim 1 wherein said sensing device includes a connector to receive a distal end of each said conductor and couple said sensing device to said detection unit.

6. The system of claim 5 further including a wiring unit to facilitate connections between said sensing device and said detection unit, wherein said wiring unit includes a connector receptacle to receive said connector and couple said sensing device to said detection unit.

7. The system of claim 1 further including a plurality of indicators to indicate drape container conditions, wherein said indicators are actuable in response to control signals generated by said detection unit in accordance with said determined occurrence of said drape container conditions.

8. The system of claim 7 wherein at least one indicator includes a visual indicator to visually indicate occurrence of a drape container condition.

9. The system of claim 7 wherein at least one indicator includes an audio indicator to produce audio signals to indicate occurrence of a drape container condition.

10. The system of claim 1 wherein said detection unit disables said thermal treatment unit in response to said potentials of said conductors indicating presence of a leak or absence of said liquid within said drape container.

11. The system of claim 1 wherein said detection unit enables said thermal treatment unit in response to said potentials of said conductors indicating presence of said liquid and absence of a leak within said drape container.

12. The system of claim 1 wherein said thermal treatment unit is operative to cool said liquid in said drape container.

13. The system of claim 1 wherein said thermal treatment unit produces a heated liquid in said drape container.

14. The system of claim 1 further including:
a plurality of said thermal treatment units to thermally treat said liquid and each including a basin, wherein said surgical drape covers and substantially conforms to each said basin to serve as said drape container for said liquid in each said basin;
a plurality of said sensing devices each including a plurality of said conductors disposed on said sterile drape surface within a corresponding drape container and extending therefrom to a non-sterile drape surface;
at least one controller to operate said thermal treatment units to control temperature of each said basin; and at least one detection unit in communication with each said sensing device to determine occurrence of drape container conditions within said each basin from said potentials of said conductors associated with that basin to control said at least one controller to operate said thermal treatment units in accordance with said determined drape container conditions.

15. A device for detecting conditions within a basin of a thermal treatment system during surgical procedures and facilitating control of thermal treatment of said basin and liquid contained therein in response to said detected conditions, said device comprising:
a surgical drape to cover and substantially conform to said basin to serve as a drape container for said liquid; and a sensing device including a plurality of conductors each disposed on a sterile drape surface within said drape container and extending therefrom to a non-sterile drape surface, wherein potentials of said conductors are responsive to contact between said conductors and said liquid and indicate conditions of said drape container.

16. The detecting device of claim 15 wherein said plurality of conductors includes a plurality of electrodes.

17. The detecting device of claim 15 wherein said drape includes an opening defined therein to permit passage of said plurality of conductors therethrough and a material segment attached to a drape surface coincident said opening to seal said opening and secure said plurality of conductors within said drape container.

18. The detecting device of claim 15 wherein said drape includes a receptacle attached to said sterile drape surface to contain a proximal portion of each said conductor, wherein said receptacle includes a series of openings defined therein to enable said liquid within said drape container to contact said plurality of conductors contained within said receptacle.

19. The detecting device of claim 15 wherein said sensing device includes a connector to receive a distal end of each said conductor and couple said sensing device to said thermal treatment system.

20. The detecting device of claim 15 wherein:
said thermal treatment system includes a plurality of said basins to thermally treat said liquid; and said drape covers and substantially conforms to each said basin to serve as said drape container for said liquid in each said basin, wherein said drape further includes a plurality of said sensing devices each including a plurality of said conductors disposed on said sterile drape surface within a corresponding drape container and extending therefrom to said non-sterile drape surface, and wherein potentials of said conductors associated with a drape container are responsive to contact between those conductors and said liquid and indicate conditions of that drape container.

21. In a thermal treatment system including a basin for thermally treating a liquid, a method of detecting conditions during surgical procedures within a container formed within said basin by a surgical drape and controlling thermal treatment of said container in response to said detected conditions, wherein said drape includes a sensing device with a plurality of conductors disposed on a sterile drape surface within said drape container and extending therefrom to a non-sterile drape surface, said method comprising the steps of:
(a) placing said surgical drape over said thermal treatment system to cover and substantially conform to said basin to serve as a drape container for said liquid;

(b) altering potentials of said conductors in response to contact between said conductors and said liquid to indicate conditions of said drape container; and (c) determining occurrence of said drape container conditions from said potentials of said conductors and controlling said thermal treatment system to thermally treat said basin in accordance with said determined drape container conditions.

22. The method of claim 21 wherein said plurality of conductors includes a plurality of electrodes, and step (b) further includes:
(b.1) altering potentials of said electrodes in response to contact between said electrodes and said liquid to indicate conditions of said drape container.

23. The method of claim 21 wherein said sensing device includes a connector to receive a distal end of each said conductor, and step (a) further includes:
(a.1) coupling said sensing device to said thermal treatment system via said connector.

24. The method of claim 23 wherein said thermal treatment system further includes a wiring unit to facilitate connections between said sensing device and said thermal treatment system, wherein said wiring unit includes a connector receptacle to receive said connector, and step (a.1) further includes:
(a.1.1) coupling said sensing device to said thermal treatment system by inserting said connector within said connector receptacle.

25. The method of claim 21 wherein said thermal treatment system further includes a plurality of indicators to indicate drape container conditions, and step (c) further includes:
(c.1) generating control signals to selectively actuate said plurality of indicators in accordance with said determined occurrence of said drape container conditions.

26. The method of claim 25 wherein at least one indicator includes a visual indicator, and step (c.1) further includes:
(c.1.1) visually indicating occurrence of a drape container condition via said visual indicator.

27. The method of claim 25 wherein at least one indicator includes an audio indicator, and step (c.1) further includes:
(c.1.1) producing audio signals to indicate occurrence of a drape container condition via said audio indicator.

28. The method of claim 21 wherein step (c) further includes:
(c.1) disabling thermal treatment of said basin in response to said potentials of said conductors indicating presence of a leak or absence of said liquid within said drape container.

29. The method of claim 21 wherein step (c) further includes:
(c.1) enabling thermal treatment of said basin in response to said potentials of said conductors indicating presence of said liquid and absence of a leak within said drape container.

30. The method of claim 21 wherein said thermal treatment system includes a plurality of said basins, and step (a) further includes:
(a.1) placing said surgical drape over said thermal treatment system to cover and substantially conform to each said basin to serve as a drape container for said liquid, wherein said surgical drape includes a plurality of said sensing devices each including a plurality of said conductors disposed on said sterile drape surface within a corresponding drape container and extending therefrom to said non-sterile drape surface;
step (b) further includes:
(b.1) altering potentials of said conductors of a corresponding drape container in response to contact between those conductors and said liquid to indicate conditions of that drape container; and step (c) further includes:
(c.1) determining occurrence of conditions of each said drape container from said potentials of said conductors associated with that drape container and controlling said thermal treatment system to thermally treat said basins in accordance with said determined drape container conditions.

31. A method of detecting conditions within a basin of a thermal treatment system during surgical procedures and facilitating control of thermal treatment of said basin and liquid contained therein in response to said detected conditions, said method comprising the steps of:
(a) forming a surgical drape to cover and substantially conform to said basin to serve as a drape container for said liquid; and (b) disposing a sensing device including a plurality of conductors on a drape portion serving as said drape container with said conductors disposed on a sterile drape surface within said drape container and extending therefrom to a non-sterile drape surface, wherein potentials of said conductors are responsive to contact between said conductors and said liquid and indicate conditions of said drape container.

32. The method of claim 31 wherein said plurality of conductors includes a plurality of electrodes, and step (b) further includes:
(b.1) disposing said electrodes on said sterile drape surface within said drape container, wherein said electrodes extend between sterile and non-sterile drape surfaces.

33. The method of claim 31 wherein step (b) further includes:
(b.1) defining an opening within said drape to permit passage of said plurality of conductors therethrough; and (b.2) attaching a material segment to a drape surface coincident said opening to seal said opening and secure said plurality of conductors within said drape container.

34. The method of claim 31 wherein step (a) further includes:
(a.1) attaching a receptacle to said sterile drape surface to contain a proximal portion of each said conductor, wherein said receptacle includes a series of openings defined therein to enable said liquid within said drape container to contact said plurality of conductors contained within said receptacle.

35. The method of claim 31 wherein step (b) further includes:

(b.1) placing a distal end of each said conductor within a connector to facilitate coupling of said sensing device to said thermal treatment system.

36. The method of claim 31 wherein said thermal treatment system includes a plurality of said basins to thermally treat said liquid, and step (a) further includes:
(a.1) forming said drape to cover and substantially conform to each said basin to serve as said drape container for said liquid in each said basin; and step (b) further includes:
(b.1) disposing a sensing device including a plurality of conductors on each drape portion serving as a drape container with said conductors of each sensing device disposed on said sterile drape surface within a corresponding drape container and extending therefrom to said non-sterile drape surface, wherein potentials of said conductors associated with a drape container are responsive to contact between those conductors and said liquid and indicate conditions of that drape container.

37. A system for detecting conditions within containers formed by surgical drapes during surgical procedures and controlling thermal treatment of said containers in response to said detected conditions, said system comprising:
thermal treatment means for thermally treating a liquid and including a basin;
a surgical drape, covering and substantially conforming to said basin, to serve as a drape container for said liquid;
sensing means for sensing conditions within said drape container, wherein said sensing means includes a plurality of conducting means for maintaining a potential, wherein said plurality of conducting means are disposed on a sterile drape surface and within said drape container and extend therefrom to a non-sterile drape surface, and wherein said potentials of said plurality of conducting means are responsive to contact between said plurality of conducting means and said liquid and indicate conditions of said drape container;
control means for operating said thermal treatment means to control a temperature of said basin; and detection means in communication with said sensing means for determining occurrence of said drape container conditions from said potentials of said plurality of conducting means and for controlling said control means to operate said thermal treatment means in accordance with said determined drape container conditions.

38. The system of claim 37 further including condition indicating means for indicating drape container conditions, wherein said condition indicating means is actuable in response to control signals generated by said detection means in accordance with said determined occurrence of said drape container conditions.

39. The system of claim 37 wherein said detection means includes thermal control means for disabling said thermal treatment means in response to said potentials of said plurality of conducting means indicating presence of a leak or absence of said liquid within said drape container.

40. The system of claim 37 wherein said detection means includes thermal control means for enabling said thermal treatment means in response to said potentials of said plurality of conducting means indicating presence of said liquid and absence of a leak within said drape container.

41. The system of claim 37 further including:
a plurality of said thermal treatment means for thermally treating said liquid and each including a basin, wherein said surgical drape covers and substantially conforms to each said basin to serve as said drape container for said liquid in each said basin;
a plurality of said sensing means each including a plurality of said conducting means disposed on said sterile drape surface of a corresponding drape container and extending therefrom to said non-sterile drape surface;
at least one control means for operating said plurality of thermal treatment means to control temperature of each said basin; and at least one detection means in communication with each said sensing means for determining occurrence of drape container conditions within said each basin from said potentials of said plurality of conducting means associated with that basin to control said at least one control means to operate said plurality of thermal treatment means in accordance with said determined drape container conditions.

42. A device for detecting conditions within a basin of a thermal treatment system during surgical procedures and facilitating control of thermal treatment of said basin and liquid contained therein in response to said detected conditions, said device comprising:
a surgical drape to cover and substantially conform to said basin to serve as a drape container for said liquid; and sensing means for sensing conditions within said drape container, wherein said sensing means includes a plurality of conducting means for maintaining a potential, wherein said plurality of conducting means are disposed on a sterile drape surface within said drape container and extend to a non-sterile drape surface, and wherein said potentials of said plurality of conducting means are responsive to contact between said plurality of conducting means and said liquid and indicate conditions of said drape container.

43. The detecting device of claim 42 wherein said drape includes an opening defined therein to permit passage of said plurality of conducting means therethrough and sealing means attached to a drape surface coincident said opening for sealing said opening and securing said plurality of conducting means within said drape container.

44. The detecting device of claim 42 wherein said drape includes securing means attached to said sterile drape surface for containing a proximal portion of each said conducting means, wherein said securing means includes a series of openings defined therein to enable said liquid within said drape container to contact said plurality of conducting means contained within said securing means.

45. The detecting device of claim 42 wherein said sensing means includes connecting means for receiving a distal end of each said conducting means and coupling said sensing means to said thermal treatment system.

46. The detecting device of claim 42 wherein:
said thermal treatment system includes a plurality of said basins to thermally treat said liquid; and said drape covers and substantially conforms to each said basin to serve as said drape container for said liquid in each said basin, wherein said drape further includes a plurality of said sensing means each including a plurality of said conducting means disposed on said sterile drape surface within a corresponding drape container and extending therefrom to said non-sterile drape surface, and wherein potentials of said plurality of conducting means associated with a drape container are responsive to contact between those conducting means and said liquid and indicate conditions of that drape container.

47. The system of claim 1 wherein said plurality of conductors are each disposed through said drape to extend between said sterile and non-sterile drape surfaces.

48. The system of claim 1 wherein said plurality of conductors each extend along said sterile drape surface and traverse a drape peripheral edge to extend between said sterile and non-sterile drape surfaces.

49. The system of claim 1 wherein said potentials of said conductors indicate conditions of said drape container including the presence of said liquid and a leak within said drape container.

50. The device of claim 15 wherein said plurality of conductors are each disposed through said drape to extend between said sterile and non-sterile drape surfaces.

51. The device of claim 15 wherein said plurality of conductors each extend along said sterile drape surface and traverse a drape peripheral edge to extend between said sterile and non-sterile drape surfaces.

52. The device of claim 15 wherein said potentials of said conductors indicate conditions of said drape container including the presence of said liquid and a leak within said drape container.

53. The method of claim 21 wherein step (c) further includes:
(c.l) determining occurrence of said drape container conditions from said potentials of said conductors including the presence of said liquid and a leak within said drape container.

54. The method of claim 31 wherein step (b) further includes:
(b.1) disposing said conductors through said drape to extend between said sterile and non-sterile drape surfaces.

55. The method of claim 31 wherein step (b) further includes:
(b.1) disposing said conductors on said sterile drape surface to extend along that surface and traverse a drape peripheral edge to extend between said sterile and non-sterile drape surfaces.

56. The method of claim 31 wherein step (b) further includes:
(b.1) disposing said conductors on said sterile drape surface within said drape container, wherein said potentials of said conductors indicate conditions of said drape container including the presence of said liquid and a leak within said drape container.

57. The system of claim 37 wherein said plurality of conducting means are disposed through said drape to extend between said sterile and non-sterile drape surfaces.

58. The system of claim 37 wherein said plurality of conducting means extend along said sterile drape surface and traverse a drape peripheral edge to extend between said sterile and non-sterile drape surfaces.

59. The system of claim 37 wherein said potentials of said plurality of conducting means indicate conditions of said drape container including the presence of said liquid and a leak within said drape container.

60. The device of claim 42 wherein said plurality of conducting means are disposed through said drape to extend between said sterile and non-sterile drape surfaces.

61. The device of claim 42 wherein said plurality of conducting means extend along said sterile drape surface and traverse a drape peripheral edge to extend between said sterile and non-sterile drape surfaces.

62. The device of claim 42 wherein said potentials of said plurality of conducting means indicate conditions of said drape container including the presence of said liquid and a leak within said drape container.