APPARATUS AND METHOD FOR AUTOMATICALLY COUNTING GAUZES AND THE LIKE USED DURING SURGICAL PROCEDURES

DESCRIPTION

The present invention refers to an apparatus and a method for automatic counting of gauzes and the like, used during surgical procedures.

One of the technical aspects to be solved during surgical procedures is that of avoiding gauzes and other objects such as swabs, pads and the like being left in the patient's body upon conclusion of the procedures.

By definition the surgical procedure is considered concluded only when the number of sterile gauzes withdrawn coincides with the number of gauzes used and discarded. Currently this count is done manually, left to the skill of the surgical staff, and is therefore subject to human error.

The patient is not sutured and woken until the count of used gauzes has been completed. Despite this, the risk of leaving gauzes in the patient's body is very high. Even with double counts, the risk of gauzes being left in the patient's body is not averted.

Leaving one or more gauzes in the patient's body causes the occurrence of serious infections and post-operative complications, which subject the patient to subsequent treatment and procedures. This leads to increased costs for the hospital, as well as legal damage claims procedures, including penal procedures in the event of death and/or physical damage to the patient.

No systems are currently known to the art which are able to account automatically for gauzes in order to eliminate causes of error and consequently raise the level of safety during surgical procedures.

US patent 3.834.390 describes gauzes used in operating rooms provided with X-ray detectable (radio opaque) threads. This is to afford the possibility of performing investigations on the patient, by means of X-rays, should the suspicion arise that a gauze has been left in the patient's body. It should be noted that this system can not be used as a preventive measure, that is, to prevent oversights during the procedure, but only as a

means of investigation after the procedure.

In any case counting of the gauzes (or similar products) is carried out manually by the surgical staff, with obvious complications due to the presence of organic liquids and blood which have dried at the time of the count, making it difficult to separate the gauzes from one another in order to count them accurately.

Patents are known to the art which describe insertion into the gauzes of devices detectable by radiofrequency, electromagnetic fields and bar codes. These detection systems provide for the use of special gauzes, different from those normally used and provided with radio opaque threads, as specified by current standards.

However, at present such systems have not been welcomed by the medical field, since the use of special gauzes leads to a considerable increase in costs with respect to the cost of i the gauzes currently used. Furthermore, the detection systems associated therewith are not very versatile and are unsuitable to be applied in an operating room since they can interfere with other complex, fundamental apparatus that must be able to operate undisturbed.

US patent 5.629.498 describes an apparatus for sensing the weight of the organic fluids absorbed by the gauzes during operations, through the use of a load cell on which a suspended container is placed. Such a system also requires the use of photoelectric cells for mechanical counting of the items placed inside the apparatus. The gauzes pass through suitable openings of a size compatible with the gauzes used.

Such a system, as it is conceived, does not guarantee a real count, therefore it is unreliable, and has not met with success in the medical field. In fact, if two gauzes were to be inserted simultaneously, something which happens absolutely often during surgery, only one gauze would be counted.

Therefore, manual counting of gauzes continues to be used in operating theatres. Manual counting, besides being inaccurate, ineffective and inefficient, leads to a lengthening of surgical procedure's times, with a resulting increase in costs. In fact, it is not possible to commence subsequent scheduled operations until the one underway is completed.

In the event of doubt and/or infection (due to a gauze being left in the patient's body) the

hospital proceeds with investigation of any forgotten gauzes by means of X-rays which sometimes do not offer a clear indication. In any case this is not a preventive procedure.

Object of the present invention is to overcome the drawbacks of the prior art by providing an apparatus and a method for automatic counting of gauzes and the like, used during surgical procedures, which are extremely accurate, effective, efficient and rapid.

This object is achieved in accordance with the invention with the characteristics listed in appended independent claims 1 and 16.

Advantageous embodiments of the invention are apparent from the dependent claims.

According to the invention, the apparatus for automatically counting gauzes and the like used during surgical procedures comprises: - a console for dispensing sterile gauzes comprising first weight sensing means for sensing the weight of the sterile gauzes withdrawn during the surgical procedure,

- and extraction system adapted to receive the discarded, used gauzes, impregnated with organic liquids, so as to allow extraction of said organic liquids,

- a weighing system comprising second weight sensing means to sense the weight of said used gauzes without the organic liquids,

- a processing system to derive the number of sterile gauzes withdrawn and the gauzes discarded, according to the weight values of the sterile gauzes and the used gauzes, respectively, and

- a control unit which puts said first weight sensing means of the console and said second weight sensing means of the weighing system into communication with said processing system.

The invention is based on the count made by sensing the weight of the used gauzes (and/or the like), after performing an operation to extract organic fluids.

It should be noted that the weight of gauzes impregnated with blood and/or organic fluids increases remarkably (in a manner that is not constant and/or foreseeable) with respect to the dry weight of said gauzes. The weight increases in relation to the time of contact (absorption) with the blood and/or organic fluids of the human body.

The weight of the soiled gauzes alone would not be sufficient to define the number

(quantity) of gauzes accurately. This is because during surgical procedures different types of gauzes are used (different weights and sizes with different absorption capability). Through extraction of organic fluids, for example by compression (a sort of squeezing) of soiled gauzes, it is possible to make their weight constant and reproducible according to the type (format) of gauze.

Further characteristics of the invention will be made clearer by the detailed description that follows, referring to a purely exemplifying and therefore non limiting embodiment thereof, illustrated in the appended drawings, in which: Figure 1 is a block diagram illustrating diagrammatically the apparatus for counting gauzes according to the invention;

Figures 2, 3 e 4 are diagrammatic views illustrating three successive stages of the gauze counting method according to the invention, performed with the apparatus of Figure 1.

The apparatus for counting the gauzes according to the invention, indicated as a whole with reference numeral 1, is described with the aid of the figures. The apparatus 1 comprises a console 2 for dispensing sterile gauzes, operationally connected to a central unit 3 for disposal and counting of the gauzes used during surgery.

The gauze dispensing console 2 comprises a plate 20 adapted to support sterile gauzes 4, 4' destined to be used during the procedure. In the plate 20 of the console are mounted weight sensing means 21, 21', such as, for example, load cells, electronic scales, or other equivalent means. The gauzes 4, 4' are stacked in groups of different types which are placed on the respective load cells 21, 21'.

Even if in the figure a console 2 with two load cells 21, 21' for two groups of different types of gauzes 4, 4', has been illustrated, it is evident that the console 2 can also have more than two load cells to receive more than two groups of gauzes of different types.

Thus the load cells 21, 21' detect the weight of the gauzes 4, 4' on the plate 20 of the console in real time. To each withdrawal of gauze(s) there corresponds a decrease in the overall weight of the gauzes available for the procedure on the plate 20 of the console.

The central unit 3 comprises a numerical control (CNC) 30 which is operationally connected to a squeezing system 5, to a weighing system 6 and to a processing system 7, such as a PC. Clearly the numerical control 30 can be integrated into the processing

system 7.

The console 2 is connected/interfaced, by cable or wireless connection, to the central unit 3. Alternatively, the console 2 can be integrated into the central unit 3. The console 2 is responsible for transmitting to the central unit 3 all withdrawals of gauzes made by personnel. Each withdrawal of gauzes 4, 4' leads to a decrease in the weight sensed by the load cells 21, 21' which, accordingly, send a signal indicating said weight decrease to the CNC 30 of the central unit. The CNC 30 communicates this information to the PC 7 to store it in a memory. Each withdrawal of gauzes 4, 4' is thus recorded automatically.

The squeezing system 5 comprises a funnel or hopper 50 to convey the used (soiled) gauzes to a compression chamber 51 in which they are squeezed to cause the organic fluids to be expelled. The side walls of the compression chamber 51 consist of two pressure plates 52, 52' at least one of which 52' moves horizontally driven by an electric motor 53, such as a direct current motor, controlled by the CNC 30.

All parts of the machine 1 destined to come into contact with the dirty gauzes, such as the funnel 50 and the compression plates 52, 52' are advantageously interchangeable so that they can be easily removed, once the count is completed, and sent for cleaning and sterilization.

Sensing means 54 able to detect the passage of the gauzes through the funnel 50 or the presence of gauzes in the compression chamber 51 are provided at the outlet of the funnel 50 and in the compression chamber 51. The gauze sensing means 54 are connected to the CNC 30.

The base of the compression chamber 51 consists of a filter or grid 55 adapted to support the squeezed gauzes and allow the passage of the organic fluids expelled by squeezing of the gauzes 40, 40'. An interchangeable receptacle 56 for collection of the organic fluids is placed beneath the grid 55. Weighing means associated with said receptacle 56 can be provided for sensing the weight of the organic fluids collected.

The weighing system 6 is disposed alongside the pressing system 5. The weighing system 6 comprises an interchangeable container 60 at the base of which are positioned weight sensing means 61, such as an electronic scale or a load cell, which weigh the contents of the container 60.

The scale 61 is connected to the CNC 30 which in turn is connected to the PC 7. In this manner the weight of the used gauzes held in the container 60 is stored in real time in the memory of the PC 7.

The PC 7 has special software which, according to the weight stored in its memory, identifies the number and type of gauzes that correspond to said weight.

Operation of the apparatus 1 according to the invention is described hereunder.

During the surgical procedure, personnel withdraw the sterile gauzes 4, 4' from the console 2. As a result, the load cells 21, 21 ', by means of the CNC 30, send the PC 7 a signal indicative of the weight of the gauzes withdrawn, which is stored in the memory of the PC 7. The software of the PC 7 according to the weight value stored, derives the exact number and type of sterile gauzes 4, 4' withdrawn.

As shown in Figure 2, the gauzes 40, 40' used in the procedure, impregnated with body fluids, are thrown into the funnel 50 and conveyed into the compression chamber 51. After the sensor means 54 have sensed the passage of the gauzes 40, 40' through the funnel 50 or the presence of the gauzes in the compression chamber 51, the CNC 30 sends a control signal to the motor 53 which drives at least one of the two pressure plates 52, 52' in translation, so as to compress the gauzes 40, 40' therebetween, as shown in Figure 3.

As a result, the organic fluids 57 squeezed from the gauzes 40, 40' pass through the grid 55 and are collected in the receptacle 56. Thus, the weight of the squeezed gauzes 40, 40' is substantially equal to the weight of the original sterile gauzes 4, 4', or in any case the change in weight between the squeezed gauzes 40, 40' and the sterile gauzes 4, 4' is such that the weight of the squeezed gauzes can be traced back to the weight of the sterile gauzes with extreme accuracy.

Once the squeezing operation has been completed, the CNC 30 sends a control signal to the electric motor 53 which drives in translation both pressure plates 52, 52' coupled to each other, so as to convey the gauzes 40, 40' towards the weighing system 6.

As shown in Fig. 4, when the pressure plates 52, 52' are on the container 60 of the

weighing system, the CNC 30 orders uncoupling thereof, then the electric motor 53 drives at least one of the plates in translation so as to move them away from each other and allow the squeezed gauzes 40, 40' to drop into the container 60.

At this point the load cell 61 of the weighing system 6 senses the weight of the gauzes 40, 40' in the container 60 and sends the CNC 30 a signal indicating the weight of the squeezed gauzes 40, 40', which is stored in the memory of the PC 7.

The software of the PC 7, according to said stored weight value, derives the exact number and type of squeezed gauzes 40, 40' contained in the container 60 of the weighing system. Thus the software of the PC 7 continuously compares the number and type of sterile gauzes 4, 4' withdrawn with the number and type of used, discarded gauzes 40, 40'. In fact this difference between gauzes withdrawn 4, 4' and gauzes discarded 40, 40' corresponds to the number and type of gauzes present in the patient's body.

In this manner it is possible to know in real time how many gauzes have been withdrawn, how many have been discarded and how many are still physically inside the patient's body (during the surgical procedure).

If the apparatus is asked for a check and the number of gauzes withdrawn 4, 4' is greater than the number of gauzes discarded 40, 40', this means that not all the used gauzes 40, 40' have been thrown into the hopper 50. That is, at least one gauze 4, 4', 40, 40' has been lost in the operating theatre or is in the patient's body. In this case, an alarm is then given to warn that the operation has not been completed.

The present invention which provides for automatic counting of the sterile gauzes 4, 4' to be used and of the discarded gauzes 40, 40' presents various advantages with respect to the prior art. In fact the possibility of human error is completely eliminated, average surgery times are reduced, the level of safety during surgical procedures is raised, and the stress on the personnel making up the surgical staff is reduced.

Furthermore the apparatus 1 proves extremely versatile, since it works with all the gauzes currently supplied to operating theatres, without the need for special dedicated gauzes.

Furthermore the receptacle 56 for organic fluids 57 deposited beneath the compression chamber 51 has a dual purpose: that of allowing the weight of the organic fluids 57 taken

during the operation to be measured and that of protecting the machine from organic fluids, with the resulting saving in washing otherwise necessary on completion of the surgery.

Furthermore the machine does not require long set-up times between one procedure and another.

Even if specific reference has been made in the present detailed description to a squeezing system 5, this squeezing system can be replaced or aided by an equivalent system for extracting organic fluids, such as a suction pump, for example.

Furthermore, even if in Figure 1 a console 2 with two load cells 21, 21' physically separated from the central unit 3 and a numerical control 30 physically separated from the processing unit 7 has been illustrated, it is obvious to experts in the field that the console 2 can have more than two load cells and that it can be integrated into the central unit 3. Furthermore the numerical control 30 can be integrated into the processing unit 7.

Numerous changes and modifications of detail within the reach of a person skilled in the art can be made to the present embodiment of the invention without thereby departing from the scope of the invention, as set forth in the appended claims.