WO2004047660A1

WO2004047660A1 - Apparatus for controlling the quantity of surgical material used in an operating room

Info

Publication number: WO2004047660A1
Application number: PCT/EP2003/013258
Authority: WO
Inventors: Luca Innocenti; Stefano Luigi Giovanni Negroponte; Riccardo Munari
Original assignee: M.G. S.N.C. Di Munari Galdino & C.
Priority date: 2002-11-27
Filing date: 2003-11-25
Publication date: 2004-06-10
Also published as: ITVR20020123A1; AU2003293721A1

Abstract

An apparatus for controlling the quantity of surgical material used in an operating room, comprising a supporting structure (2) for a receptacle (4) that is designed to receive the used surgical material, and comprising sensors (6a,6b) adapted to detect the transit of the used surgical material through the inlet (4b) of the receptacle (4).

Description

APPARATUS FOR CONTROLLING THE QUANTITY OF SURGICAL MATERIAL USED IN AN OPERATING ROOM Technical Field

The present invention relates to an apparatus for controlling the quantity of surgical material used in an operating room. Background Art

Keeping control over the quantity of surgical material, such as for example instruments, gauzes, sheets and so forth, used during surgical procedures is a strongly felt problem. In particular, it is extremely important to control precisely the number of gauzes used during surgical procedures, in order to avoid the severe consequences that arise from leaving one or more gauzes in the body of the patient.

This control is currently ensured by means of a count, performed manually by nursing staff, of the gauzes prepared before starting the procedure and by means of an equally manual count of the gauzes used during the procedure.

The drawback that affects these manual counts is of course the possibility of human error during their execution. Disclosure of the Invention

The aim of the present invention is to provide a valid solution to the problem described above by providing an apparatus for controlling the quantity of surgical material used in an operating room that allows to make this control, and particularly the count of the gauzes used during surgical procedures, safer and simpler.

Within this aim, an object of the present invention is to provide an apparatus for controlling the quantity of surgical material used in an operating room that is compact and can be installed easily in an operating room. Another important object of the present invention is to provide an apparatus for controlling the quantity of surgical material used in an operating room that is capable of quantifying the weight of the used surgical material and in particular of quantifying the amount of blood imbibing the used gauzes. Another object of the present invention is to provide an apparatus for controlling the quantity of surgical material used in an operating room that is constructively simple and easy to use and handle.

Another object of the present invention is to provide an apparatus for controlling the quantity of surgical material used in an operating room that has low production costs in order to be competitive also from an economical standpoint.

This aim and these and other objects that will become better apparent hereinafter are achieved by an apparatus for controlling the quantity of surgical material used in an operating room, characterized in that it comprises a supporting structure for a receptacle that is designed to accomodate said used surgical material and sensing means adapted to detect the transit of said surgical material through the inlet of said receptacle.

Advantageously, the apparatus according to the invention comprises counter means that can be functionally connected to said sensing means in order to count the surgical material detected by said sensing means.

Brief description of the drawings

Further characteristics and advantages of the invention will become better apparent from the description of a preferred but not exclusive embodiment of an apparatus for controlling the quantity of surgical material used in an operating room according to the invention, illustrated by way of non-limiting example in the accompanying drawings, wherein:

Figure 1 is a perspective view of the apparatus according to the invention;

Figure 2 is a side elevation view of a detail of the apparatus according to the invention, with parts shown in partial cross-section; Figure 3 is a top view of the apparatus according to the invention; Figure 4 is a sectional view, taken along the line IV-IV of Figure 3; Figure 5 is a schematic view of the apparatus according to the invention, functionally connected to a computer. Ways to carrying out the Invention

In the examples of embodiments that follow, individual characteristics, given in relation to specific examples, may actually be interchanged with other different characteristics that exist in other examples of embodiment. With reference to the figures, an apparatus for controlling the quantity of surgical material used in an operating room according to the invention, generally designated by the reference numeral 1, comprises a supporting structure 2 that has a base 2a that is preferably provided with castors 2b.

A supporting rod 2c rises from the base 2a, preferably at an adjustable height, and supports two arms 2d that are substantially parallel and have a substantially horizontal axis, and a body 3, which is substantially flat and arranged above said two arms 2d.

In particular, the arms 2d are adapted to support, preferably in a detachable manner, a receptacle 4 that is designed to accomodate the surgical material that is used during surgical procedures and is therefore to be discarded, so as to allow its collection.

Advantageously, said receptacle 4 is constituted by a collection bag 4a, made for example of plastics and disposable, and has, substantially at its inlet 4b, sleeve elements 4c in which it is possible to insert the arms 2d in order to allow to fix it detachably to the supporting structure 2. Preferably, as shown in Figure 2, the arms 2d are of an extendable type, so that it is easy for the user to couple the receptacle 4 to the supporting structure 2.

An opening 5 is provided on the body 3 and lies on a substantially horizontal plane. The inlet 4b of the receptacle 4 is located below the opening 5 and substantially adjacent thereto. Also according to the invention, the apparatus 1 is provided with sensing means that are adapted to detect the transit of the used surgical material through the inlet 4b of the receptacle 4.

In particular, in the embodiment shown in the figures, the sensing means are arranged substantially at the opening 5, so that they can detect the transit through the opening 5 of the used surgical material, to be collected in the underlying receptacle 4.

Preferably, the sensing means use optical sensor means, such as for example photocell means, which are constituted by emitter means 6a and receiver means 6b arranged on opposite sides of the opening 5 so that the beam of light projected by the emitter means 6a onto the receiver means 6b passes transversely through the opening 5, so as to form an optical barrier.

Advantageously, the sensing means can be functionally connected to counter means CM, which are designed to count the surgical material detected by the sensing means as a consequence of the interruption of the beam of light emitted by the emitter means 6a caused by the transit through the opening 5 of the surgical material that falls freely from a region overlying the opening 5 toward the inlet of the receptacle 4.

In an equivalent manner, said counter means can be accommodated in an appropriately provided box-like portion formed on the body 3 or can be external with respect to the supporting structure 2 or with respect to the body 3 and can therefore be connected to the sensing means, for example by means of a connecting cable.

Conveniently, the counter means use a memory unit to store the quantity of surgical material to be used during the surgical procedure and the number of transits detected by the sensing means.

There are also, at the body 3, user interfacing means that comprise a display 8a and a keypad 8b for setting the counter means.

Advantageously, it is possible to functionally connect to the counter means CM, printing means PM, constituted for example by an ordinary printer, in order to allow printing of a report regarding the number of transits detected. Said printing means can be optionally integrated with the supporting structure 2 or the body 3.

In order to ensure its maximum portability, the apparatus according to the invention is provided with electric power supply means EP equipped with a rechargeable battery that is accommodated within an appropriately provided seat, from which it can be removed easily to allow its recharging.

Such rechargeable battery ensures the operation of the apparatus according to the invention for a preset period of maximum continuous running time and its discharge is indicated with a certain advance by suitable visual and/or acoustic indicators. If the rechargeable battery is completely discharged and the apparatus 1 shuts down, it is sufficient to replace the rechargeable battery in order to be able to continue the activity in progress, since the memory unit of the counter means is capable of ensuring the persistence of the data related to the count performed.

Conveniently, there are also signaling means SM, which are capable of emitting an optical and/or acoustic warning signal when the counter means have counted a preset quantity of used surgical material and optionally whenever the sensing means detect the transit of the surgical material through the opening 5.

Advantageously, it is possible to fix detachably to the body 3 a hopper element 8 in order to facilitate the conveyance of the used surgical material toward the opening 5.

As shown in the figures, the apparatus according to the invention can be configured as a trolley by having, in addition to said castors 2b, a steering handle 9 fixed to the supporting structure 2.

Operation of the apparatus according to the invention is as follows. First of all, the apparatus according to the invention is preset for use by acting on the supporting rod 2c in order to adjust the body 3 to a suitable height, fastening the receptacle 4 to the arms 2d, taking care to arrange the inlet 4b below the opening 5 and fixing the hopper element 8 to the body 3.

By way of the hopper element 8, the used surgical material to be disposed is guided toward the receptacle 4 and the sensing means detect its transit through the opening 5. The counter means, reset to zero beforehand, count the number of transits sensed by the sensing means and the count is displayed on the display 8a.

The signaling means emit a warning signal, such as for example a two- tone beep, in order to report to the user that the sensing means have detected the transit of the used surgical material introduced in the hopper element 8, without said user having to look at the display 8a.

Once the count has ended, it is possible to request the printing means PM, for example by way of a wired, or wireless, or infrared connection, to print the report regarding the count performed.

By means of the keypad 8b it is possible to set the counter means, before starting the count, with data such as the number of prepared items of surgical material that one intends to use during the surgical procedure or the remaining number of items still to be counted.

When the counter means have counted a number of items equal to the set number, the signaling means emit a signal. Accordingly, the signaling means can emit a signal at each individual transit and/or upon reaching a predefined value.

When the surgical procedure ends, the user is able to know rapidly and precisely the quantity of surgical material used and whether it matches the quantity prepared for the procedure. The invention thus conceived is susceptible of numerous modifications and variations, all of which are within the scope of the appended claims.

Thus, for example, the optical sensing means can be constituted, as an alternative, by television camera means TM of a conventional or infrared type, which detect the transit of the used surgical material by means of an image acquisition or can be constituted by means that employ the reflection of a beam of laser light or of any other kind of visible or non- visible light, said means being formed by a light source and by mirrors that reflect the light emitted by the light source at a precise angle.

According to another embodiment of the invention, the sensing means can also comprise means for identifying the type of surgical material used, which are advantageously associated cooperatively with the counter means, so that the apparatus according to the invention is able to discern the type of surgical material used and introduced in the receptacle 4 in addition to counting it. Substantially, by way of the means for identifying the type of surgical material used, the apparatus according to the invention is for example capable of distinguishing whether the surgical material introduced in the receptacle 4 is constituted by a gauze of one kind or a gauze of another kind or of distinguishing a gauze from a mask or a sheet and so forth. Conveniently, said means for identifying the type of surgical material used employ reader means RM that are adapted to detect an identification component or feature associated with the surgical material.

In detail, the reader means can be constituted by magnetic sensor means that are capable of recognizing an identification component that is constituted for example by an element made of a suitable detectable material, such as a magnetic material. In this case, the reading performed by the reader means allows, for example, to distinguish only the particular surgical material that is provided with the identification component from the others that are not provided with it. In practice, it is possible to make provisions so that if gauzes of two different types are used during the surgical procedure, the identification component is applied for example to gauzes of one type and is not applied to those of the other type, so that the type provided with an identification component can be distinguished, by way of the reader means, from the type that is not provided with it. According to another example of embodiment, the reader means can be constituted by inductive sensor means, which are capable of detecting, during the transit of the used surgical material through the inlet 4b or in general when the used surgical material is inside the receptacle 4, an identification component constituted for example by an electronic microcircuit or microchip that stores data for identifying the type of surgical material with which the identification component is associated in order to allow qualitative discrimination of said surgical material.

More specifically, the inductive sensor means are capable of reading a code that is programmed in the electronic microcircuit, which can be conveniently a unique identification code that is associated for example by means of an appropriately provided relational database with a corresponding type of surgical material.

This example of embodiment, therefore, allows to recognize all the types of surgical material that have been introduced in the receptacle 4 and to count, again by using the counter means, the number of items of each type of surgical material introduced in the receptacle 4. For this purpose, the memory unit of the counter means is provided advantageously with at least two separate memory cells, each of which is adapted to store the number of counted items of a respective type of surgical material. From the operation point of view, the transit of the surgical material through the inlet 4 in fact activates the sensing means 4 and in particular the means for identifying the type of used surgical material and the counter means, which update the content of the appropriately provided cell of their memory unit, which stores the number of counted items of the type of surgical material detected by the identification means.

The electronic microcircuit can be programmed optionally so as to store, in addition to the unique identification code, other information related to the individual item of surgical material with which it is associated, such as for example its weight before use or the material of which it is made or other data that can be considered useful. In another variation, the sensing means can comprise volume measurement means, which can be provided with optical volume detectors constituted for example by at least three television cameras or by a television camera TM and at least three optical barriers. In a manner known per se, said three television cameras TM are arranged conveniently along the three fundamental dimensions so as to be able to reconstruct with sufficient approximation the outer shape of the object and therefore assess its volume. Advantageously, the television cameras are controlled by an image processing device provided with a management software that allows to extract, from the images that arrive from the television cameras, the three- dimensional shape of the detected objects.

Moreover, the apparatus according to the invention can comprise weighing means WM that are designed to measure the weight of the used surgical material. By way of example, said weighing means can be constituted by an electronic measurement circuit that is functionally connected to at least one load cell, which can be associated, with reference to the illustrated example, with the arms 2d or, according to another possible embodiment of the invention, with a supporting element that supports a rigid container that provides the receptacle 4. With such a structure, the weighing means allow to know the total weight of the surgical material accumulated in the receptacle 4 (i.e., the total weight of all the surgical material deposited in the receptacle 4), so that the weight of each individual item of used surgical material introduced in the receptacle 4 can be determined on the basis of the increase in said measurement as a consequence of its insertion in the receptacle 4, i.e., by simply determining the difference between the weight measured by the weighing means after inserting the individual item of surgical material in the receptacle 4 and the weight measured by said means before said insertion. In this way, by integrating the weight variation measured by the weighing means with the identification information that can be obtained from the means for identifying the type of surgical material used, it is possible to know and assign to each one of the surgical materials used and accumulated in the receptacle 4 its respective weight. Furthermore, by using the information related to the weight of each surgical material before use, contained in the corresponding associated electronic microcircuit, and by knowing, by way of the weighing means, the weight of each surgical material used, it is possible to calculate easily by subtraction the weight of the liquid and more specifically of the blood of the patient absorbed by each surgical material during its use during the surgical procedure. For example, it becomes possible to determine the amount of blood absorbed by gauzes and sheets and so forth and to know the total amount of blood absorbed by all the surgical materials used during the surgical procedure. Accordingly, the report regarding the performed count that can be printed by the printing means can contain, for example in table form, the number of items used for each type of surgical material and the weight of the blood absorbed by each one of said items, as well as the weight of the blood absorbed as a whole by all the used surgical material. Moreover, it should be noted that the type of surgical material used can also be recognized by said television camera means, particularly if they are of the color type, since by color determination it is possible to discriminate type of surgical material used.

It should also be added that by way of a processing of the data that arrive from the optical volume sensors together with the processing of the weight measurement obtained by the weighing means, it is possible to define, if of course one has a statistically significant number of samples available, the material that constitutes the surgical material used and introduced in the receptacle 4 and accordingly distinguish its type. In another possible variation of the invention, it is possible to connect the apparatus according to the invention to a computer 10, such as an ordinary personal computer, for example a portable one, to program the counter means or perform the count.

An embodiment is also provided in which the apparatus according to the invention can be connected to other devices and can integrate or provide for the integration of the measurements taken together with other information so as to be able to perform other functions, which may be diagnostic, management-related, et cetera. For example, it is possible to connect the apparatus according to the invention to the device or devices designed to manage the inventory in order to achieve automatic removal of the material used from inventory.

The surgical material used can also be conveyed inside the receptacle 4 by suitable conveyor means 11, such as for example conveyor belts or the like. All the characteristics of the invention indicated above as advantageous, convenient or the like may also be omitted or may be replaced by equivalents.

In practice it has been found that the invention has achieved its intended aim and objects in all the embodiments. In particular, it is noted that the apparatus according to the invention has proved to be extremely versatile, since it can be used to count any type of surgical material used in an operating room, thanks to its particularity of having both the counter means and the means for identifying the type of surgical material used, and by the fact that it is provided with the means for measuring the volume of surgical material used and the weighing means to determine the amount of liquids absorbed by the used surgical material.

In practice, the materials used, as well as the shapes and dimensions, may be any according to requirements.

All the details may further be replaced with other technically equivalent elements. The disclosures in Italian Patent Application No. VR2002A000123 from which this application claims priority are incorporated herein by reference.

Claims

1. An apparatus for controlling the quantity of surgical material used in an operating room, characterized in that it comprises a supporting structure (2) for a receptacle (4) that is designed to accomodate the used surgical material and sensing means (6a,6b) adapted to detect the transit of said surgical material through the inlet (4b) of said receptacle (4).

2. The apparatus according to claim 1, characterized in that it comprises counter means (CM) that can be connected functionally to said sensing means (SM) in order to count the surgical material detected by said sensing means.

3. The apparatus according to one or more of the preceding claims, characterized in that said sensing means (SM) comprise optical sensor means (6a,6b).

4. The apparatus according to one or more of the preceding claims, characterized in that said optical sensor means (6a,6b) comprise photocell means.

5. The apparatus according to one or more of the preceding claims, characterized in that said optical sensor means (6a,6b) comprise television camera means (TM).

6. The apparatus according to one or more of the preceding claims, characterized in that said optical sensor means (6a,6b) comprise sensing means based on the reflection of a beam of light.

7. The apparatus according to one or more of the preceding claims, characterized in that said sensing means (SM) comprise means (RM) for identifying the type of said surgical material used.

8. The apparatus according to one or more of the preceding claims, characterized in that said means for identifying the type of said used surgical material comprise reader means (RM) that are adapted to detect an identification component that is associated with said surgical material.

9. The apparatus according to one or more of the preceding claims, characterized in that said reader means (RM) comprise magnetic sensor means, said identification component comprising an element made of magnetic material.

10. The apparatus according to one or more of the preceding claims, characterized in that said reader means (RM) comprise inductive sensor means, said identification component comprising an electronic microcircuit.

11. The apparatus according to one or more of the preceding claims, characterized in that said sensing means (SM) comprise means for measuring the volume of said used surgical material.

12. The apparatus according to one or more of the preceding claims, characterized in that it comprises means (WM) for quantifying absorbed liquids, which are adapted to calculate the quantity of liquids of the patient absorbed by said used surgical material.

13. The apparatus according to one or more of the preceding claims, characterized in that said means for quantifying the absorbed liquids comprise means for weighing (WM) said used surgical material.

14. The apparatus according to one or more of the preceding claims, characterized in that it comprises user interfacing means (8a, 8b) that are functionally connected to said counter means (CM).

15. The apparatus according to one or more of the preceding claims, characterized in that said user interfacing means comprise a display (8a) and a keypad (8b) for setting said counter means (CM).

16. The apparatus according to one or more of the preceding claims, characterized in that it comprises electric power supply means (EP) that are provided with a rechargeable battery.

17. The apparatus according to one or more of the preceding claims, characterized in that it comprises printing means (PM) that can be functionally connected to said counter means (CM).

18. The apparatus according to one or more of the preceding claims, characterized in that it comprises signaling means (SM) that are adapted to signal the counting and reaching of a preset quantity of said surgical material detected by said sensing means (SM).

19. The apparatus according to one or more of the preceding claims, characterized in that said supporting structure comprises a body (3) that forms an opening (5) that is provided with said sensing means (SM) and lies on a substantially horizontal plane, the inlet (4b) of said receptacle (4) being arranged below said opening (5).

20. The apparatus according to one or more of the preceding claims, characterized in that it comprises a hopper element (8) that can be detachably fixed to said body (3) to convey said surgical material toward said opening (5).

21. The apparatus according to one or more of the preceding claims, characterized in that said receptacle (4) is formed inside a collection bag (4a) that can be detachably coupled to said supporting structure (2).

22. The apparatus according to one or more of the preceding claims, characterized in that it can be functionally connected to a computer (10).

23. The apparatus according to one or more of the preceding claims, characterized in that it comprises conveyor means (11) that are adapted to convey said used surgical material toward the inlet of said receptacle (4).