WO1994017767A1 - Surgical compresses and device for counting same - Google Patents

Abstract

A device for counting surgical compresses (8), a method for counting surgical compresses (8), and easily countable and detectable compresses (8), are disclosed. In particular, the use of a metal detector (5, 105, 106) to count compresses (8) having metal markers (7, 10, 101, 102) is disclosed.

Description

 SURGICAL COMPRESSES AND DEVICE FOR COUNTING THE SAME.

The present invention relates to a device for counting surgical compresses, to a method for counting surgical compresses as well as to compresses allowing easy counting and detection. The present invention relates to a device for counting compresses (8) used during surgical procedures. It is composed of a counter (4) of surgical compresses avoiding any manipulation of the contaminated compresses (8) and allowing a counting of the compresses (8) used by prohibiting any forgetting of compresses (8) inside the patient's body and compresses (8) marked by a recognition device (10, 7).

The technical sector of the invention is in the medical field, more particularly surgical, especially in the types of surgery where the risk of forgetting compresses in the patient's body is significant. The main application of the invention is the counting of compresses (8) used in general, bone, visceral, gynecological surgery, etc., in order to prevent one or more compresses from being forgotten in situ when the closure is closed. operative route.

Indeed, until then, the compresses are counted manually by a third person.

The compresses are counted before sterilization, then sterilized in packs in a determined number, then counted by the operating aid before being used by the operator. Once the compresses are soiled, they are then recounted by a third person, which leads to a risk of errors.

In case of mismatch, there are compresses with a radiopaque marker which allows the surgeon to check their absence in the operating site.

But for this, it is necessary to have radiography equipment with all the problems that this entails, x-rays, sterilization, immediate availability of the device, difficult interpretation of the image, etc.

In case of doubt, the surgeon must intervene manually to remove this foreign body with all the consequences that this entails for the patient.

The problem posed is thus to have complete equipment for counting compresses (8) to allow the surgical team to find the same number of compresses (8) after use, as before use and without manipulation. from a third person.

Patent Application GB-A-2 242 551 describes a device for detecting and identifying surgical instruments as well as compresses when they are introduced into a receptacle. Nothing is provided to allow the detection of a plurality of compresses introduced simultaneously. In addition, the identification of each object introduced between the use of a computer with a high cost price and whose sterilization or isolation from the operating site poses problems.

Patent Application FR-A-2,078,861 describes compresses comprising a magnetic marker enabling the detection of compresses which have been forgotten on the operating site. This patent does not provide for any device for counting used compresses.

It is therefore an object of the present invention to provide a device making it possible to ensure that all the compresses used during a surgical operation have been removed from the operating site. It is also an object of the present invention to provide such a device whose operation is particularly safe.

It is also an object of the present invention to provide such a device, the operation of which is automatic.

It is also an object of the present invention to provide compresses capable of being detected by such a device.

It is also an object of the present invention to offer a detector or counter for easily sterilizable compresses.

It is also an object of the present invention to offer a stand-alone, compact compressors detector or counter. It is also an object of the present invention to offer a pad detector having a moderate cost price.

It is also an object of the present invention to offer compresses comprising a marker allowing their detection or counting whose performance is not degraded by sterilization.

It is also an object of the present invention to offer such compresses having a low cost price.

These problems are solved according to the present invention by depositing on each compress to count a magnetic or electromagnetic marker, by counting the new (marked) compresses, by depositing the used compresses in a detector or a counter of compresses according to the invention and by carrying out a detection or counting of the compresses present in the detector or the counter at the end of the operation.

Advantageously, all the compresses comprise an identical or similar marker, the collective detectable effect of all the markers being equal to the sum of the individual effects of each marker and to an individual effect multiplied by the number of compresses. Thus, it suffices to divide the detected value by the value corresponding to a pad to deduce the number of pads present in the detector. As a variant, the value of the collective effect of all the markers of the new compresses is detected and memorized before the operation and this value is compared with the value detected at the end of the operation. In the event of a match, all the used compresses are in the detector according to the present invention. Otherwise, it is imperative to find the missing pad (s).

In the preferred embodiment of the device according to the invention, each compress is provided with a metallic element, in particular non-magnetic, advantageously identical or substantially identical, preferably in the form of a thin metal strip, the detector or counter of the markers being of the “metal detector” type detecting the quantity of metal present in a container for receiving the compresses of the detector.

The counting carried out during or after the removal of the pads (8) must be compatible with a random ("loose") removal of several pads (8). Only specifically marked compresses (8) can be counted.

The invention mainly relates to surgical compresses, characterized in that they comprise an electromagnetic marker comprising a non-magnetic metallic element, in particular a thin metal strip, preferably made of aluminum or an insulated wire, in particular made of copper.

The invention also relates to a set of surgical compresses, characterized in that each compress comprises a magnetic or electromagnetic marker having identical magnetic or electromagnetic properties, the collective detectable effect of all the markers being equal to the sum of the individual effects of each marker.

The subject of the invention is also a device for counting surgical compresses comprising a magnetic or electromagnetic marker, preferably a soft iron element, a permanent element or a metallic element, in particular a thin strip or a wire comprising a receptacle, in particular a tank intended to receive the compresses to be counted and means for displaying the number of compresses detected, characterized in that it comprises means for detecting the number of compresses present simultaneously in the receptacle.

The invention also relates to a device, characterized in that it comprises a metal detector making it possible to detect the quantity of metal present in the receptacle.

The invention also relates to a device, characterized in that the metal detector comprises a primary winding supplied with alternating current and a secondary winding placed nearby, preferably around a receptacle for countable compresses and measuring means the relative phase shift between the signals present in the primary and secondary windings.

The invention also relates to a device, characterized in that the primary winding and the secondary winding are each connected to a signal shaping and impedance matching circuit. The invention also relates to a device, characterized in that the metal detector comprises a multiplier of the signals coming from the primary and secondary windings.

The invention also relates to a device, characterized in that it comprises a circuit ensuring the scaling and calibration of the relative phase shift between the primary winding and the secondary winding.

A subject of the invention is also a method of counting surgical compresses comprising the steps consisting in: a) placing a magnetic or electromagnetic marker on each compress, b) counting the new compresses to be used, c) disposing the used pads to be counted near a magnetic or electromagnetic detector, in particular in a tank, d) detect and count used pads, e) display the number of pads detected, f) compare the number of new pads counted in step b) with the number of compresses displayed in step d), characterized in that step d) of detection and counting of the compresses is a detection of the compresses simultaneously present near the electromagnetic detection means, in particular in the tank , at the time of measurement.

The invention also relates to a method, characterized in that step d) of counting of compresses is a step of detecting the quantity of metal present in the receptacle or the tank.

In a first alternative embodiment, the counter is equipped with a device creating a magnetic field. The compresses (8) are equipped with a permanent magnet (10) or not (7) or with any material having a behavior not indifferent to the magnetic field. All the compresses in the same set have identical magnets, permanent (10) or not (7).

The main application of this invention is therefore the location and counting of said recognition elements (10, 7) included in the compress (8). The following description and Figure 1 correspond to a particular embodiment by "flow measurement" (1): The principles:

- The compresses (8) are marked by means of a permanent magnet (10), placed inside a plastic capsule (11) sewn or glued to each compress (8).

- The tank (5) (non-magnetic material) intended to receive the compresses (8) arranged along the axis of two coils (12) in the HELMOHOLTZ position.

- A calibrated flow meter (1), connected to the two coils (12), indicates the number of compresses (8) present in the tank (5).

- Note / Orientation of the marking magnets (10): in order to measure a magnetic flux proportional to the number of pads (8) deposited, the marking magnets (10) must be oriented in the same direction. As such, two solutions can be envisaged: ^* The geometry of the magnet (10) - free of any movement in the capsule (11) - characterizes a specific orientation.

^* The magnet (10) is oriented by means of a coil (12) provided for this purpose: OPERATION:

At the end of the surgical intervention, all the compresses 0 (8) used are supposed to have been deposited in the tank (5) by the surgeon. The operation is as follows:

1) Energizing the magnet orientation coil (12) (10) (optional).

2) Energizing the flow meter (1). 5 3) Flow measurement.

4) Display of the number of compresses (8) [magnets (10)] in the tank (5).

In the event of a mismatch with the number of compresses (8) used, research on the patient is carried out by means of a detector of the "Hall effect sensor" type.

The following description and FIG. 2 correspond to a particular embodiment by "measuring the field" (2):

Field measurement:

PRINCIPLE: - The compresses (8) are marked by means of a permanent magnet (10), placed inside a plastic capsule (11) sewn or glued to each compress (8).

- The tank (5) (non-magnetic material) intended to receive the compresses (8) deposited is placed in an enclosure where the Hall effect probes (13) are arranged.

- A calibrated magnetometer (14), connected to the probes (13), indicates the number of compresses (8) present in the tank (5).

Two types of measurement are possible: 1) Read head: the (or the) probe (s) (13) are placed along a vertical axis constituting a "read head". The compresses (8) being deposited in the tank (5), the latter is maneuvered in rotation, while the magnetometer (14) records the variation of the field for one revolution. Such a device requires an orientation of the magnets (10). 2) Probes (13) arranged around the perimeter of the enclosure: the magnets (10) being oriented "north face" outwards, the magnetic field is measured by several probes (13) arranged around the perimeter of the pregnant:

OPERATION: At the end of the surgical intervention, all the compresses

(8) used are assumed to have been deposited in the tank (5) by the surgeon. The operation is as follows:

1) Energizing the magnet orientation device (10). 2) Solution N ° 1: energizing the magnetometer (14) and rotating the tank (5) [orientation of the magnets (10)].

Solution No. 2: energizing the magnetometer (14) [orientation of the magnets (10)].

3) Field measurement. 4) Display of the number of compresses (8) [magnets (10)] in the tank (5).

If the number of compresses (8) used does not match, research on the patient is carried out using a metal detector. The description and FIG. 3 correspond to a particular embodiment by "weighing" (3):

Weighing:

PRINCIPLE: 5 - The compresses (8) are marked by means of one or more soft iron balls (7) placed inside a plastic capsule (9) sewn or glued to each compress (8).

- The tank (5) (non-magnetic material) intended to receive the compresses (8) deposited is placed inside a coil (6) where it is suspended or placed on a calibrated scale (15).

OPERATION:

At the end of the surgical intervention, all the compresses (8) used are supposed to have been deposited in the tank (5) by the surgeon. The operation is then as follows: 5 1) Measurement of the force No. 1 exerted on the balance (15) (mass of the deposit).

2) Energizing the coil (6) and creating a vertical force applied to each of the balls (7): Fm.

3) Measure of the force N ° 2 exerted on the balance (15): F1 + 0 Fm.

4) Display of the number of compresses (8) [balls (7)] in the tank (5): F2 - F1.

In the event of a mismatch with the number of compresses (8) used, research on the patient is carried out by means of a metal detector.

For these three cases, the information means is a visual display means (4) or a sound means.

The above descriptions and the figures below represent exemplary embodiments of the invention but are in no way limiting. 0 The marker must not prevent folding of the compress.

Either a small marker (Figures 1 to 3) or a flexible marker capable of being folded with the compress (Figures 4 and 5) is used.

In Figure 4, we can see the preferred embodiment of a compress 8 according to the invention comprising a metal strip 101 5 forming an electromagnetic marker. In the preferred embodiment, using a rectangular strip having, for example 10 cm in length and 5 mm in width, made of thin aluminum, for example of the food grade aluminum type.

Advantageously, a strip of plasticized aluminum or metallized plastic is used, which allows the marker 101 to be fixed to the fabric of the compress by heating, for example by ultrasonic welding. Excellent results have been obtained using plasticized edible aluminum. If necessary, in particular for reasons of hygiene, biological compatibility and / or to meet standards, the metal strip 101 can be entirely included in hermetically sealed plastic film.

The pad 8 of Figure 4 can be detected safely and effectively while having a moderate cost.

In FIG. 5, one can see an alternative embodiment of a compress 8 according to the present invention comprising a metallic wire 102 of small diameter forming an electromagnetic marker.

Advantageously, the wire comprises an insulating sheath 103 ensuring, on the one hand, its fixing, for example on the tissue of the compress, in particular by ultrasonic welding and, advantageously, its hermetic sealing.

In such a case, the wire 102 has, advantageously at each of its ends, a length slightly less than that of the sheath 103. To reduce the cost, it is possible to use signal transmission wires of known type, such as telephone wire. In FIG. 6, one can see a particularly efficient example of a detector or pad counter of FIGS. 4 and 5. The detector comprises a receptacle for the pads to be detected or counted, for example a receiving tank 5 advantageously non-metallic and not magnetic. The device of FIG. 6 is advantageously of the type

"metal detector" for measuring the total amount of metal present in the tank 5 for receiving the pads. This device makes it possible to detect or count the compresses present in the tank 5 independently of their order of introduction and is not disturbed by the simultaneous introduction of several compresses. In addition, the compresses soiled with physiological fluid are perfectly counted and detected. The detector or counter of FIG. 6 comprises a generator of sine waves 104 operating for example between 100 and 200 kHz supplying a first coil 105 forming the primary winding of a transformer. One or more coils 106 form the secondary winding of the transformer. The coil 105 has for example 130 turns, an internal diameter of 160 mm, a height of 195 mm and an inductance of 1 mH. The secondary winding 106 advantageously comprises two coils, each comprising 65 turns and having a diameter of 160 mm, a height of 97.5 mm and an inductance of 400 mH. Advantageously, the secondary windings 106 are placed contiguously inside the primary winding 105. Advantageously, the coils 106 are connected in opposition. The output of the coil (s) 106 is connected to a circuit 107 for measuring the quantity of metal present in the tank 5. It is for example possible to use a metal detection circuit of known type measuring the variation of the frequency picked up by the coil 106 as a function of the quantity of metal present in the tank 5. However, advantageously a metal detector specially developed for the device according to the present invention is implemented, comprising means for measuring the phase shift signals from the coils 105 and 106 having a significantly higher resolution. However, it is important that the total phase shift introduced by all the pads cannot be greater than 360 °, which would cause ambiguity in the measurement. With the compresses of figure 4, we obtain a resolution of a 10th of a degree per compress. As a result, there is no risk of ambiguity for normal surgical operations for which one never uses more than one of a few tens of compresses. However, the volume of the tank 5 is advantageously limited so as not to allow the introduction of a number of compresses capable of causing a phase shift greater than 360 °. It should be noted that the device according to the present invention is intended to ensure that one or more compresses have not remained in the operating site. The risk of having forgotten several tens or hundreds of compresses can be considered negligible.

The circuit 107 advantageously includes a first impedance matching and wave shaping circuit 108 whose input is connected to the output of the primary coil 105 and a second impedance matching and waveforming circuit 109 connected to the output of the coils 106 placed in series. We use, for example, the circuit sold under the reference AD521 by the company ANALOG DEVICE. The outputs of circuits 108 and 109 are connected to the inputs of a multi-channel 110 ensuring analog multiplication of the signals. For example, the circuit sold under the reference AD630 by the company ANALOG DEVICE is used. The output of the multipier 110 is connected to the input of a low-pass filter 111 ensuring the removal of the alternative components of the signal. The cut-off frequency of the filter 111 is for example equal to 100 Hz. The output of the filter 111 is connected to the input of a processing circuit 112. The processing circuit 112 ensures the scaling of the signal, its display and its possible calibration.

In a first exemplary embodiment, the processing circuit 112 operates in analog.

Advantageously, the processing circuit 112 operates in digital mode after sampling the signal at the output of the filter 111. One uses, for example, a microcontroller or a signal sampling device, and an associated low power microprocessor program memories of the permanent memory, read-only memory, erasable programmable read-only memory, or electrically erasable programmable read-only memory (ROM, PROM, EPROM, EEPROM in English terminology), as well as a working random access memory (RAM in Anglo-Saxon terminology). The output of the processing circuit 112 is connected to a display device 113, for example comprising so-called "seven-segment" digital displays or an alphanumeric display, for example with liquid crystals or light emitting diodes. It may be advantageous to be able to keep a record of the counting of compresses to serve as proof in the event of a dispute about the good progress of the operation by the patient or his family. In such a case, the processing circuit can be connected to a printer 114 and / or to a recorder (not shown).

Advantageously, the circuit 107 includes means for calibrating the pad counter or for selecting a particular type of pad and markers. In such a case, an input device 115 in particular a keyboard makes it possible to introduce a reference value into the processing device 112. In a first case, it is for example a keyboard making it possible to select the type of compresses used among a plurality of types of memorized compresses. One can for example choose between a compress having a band 101 of Figure 4 and a compress having a wire 102 of Figure 5. Similarly, various sizes of compresses may include markers 1 1 or 102 having different sizes.

In a second exemplary embodiment, the quantities and / or the type of metal contained in the compresses which it is desired to use are entered on the keyboard 115.

In a third embodiment, a single compress is placed in the tank 5 and a measurement is triggered, which causes the device to be calibrated. In a fourth exemplary embodiment, the set of compresses to be used is placed during the operation, and by a command on the keyboard 115, a measurement with memorization is triggered. This measurement can be carried out both at once and several times if, during operation, it becomes apparent that the number of compresses initially planned may not be sufficient to carry out the operation . In such a case, the results of the various measurements of the new compresses are summed. After the operation, the used compresses are placed, as well as possibly the compresses which have not been used, but which have been counted before the operation, in the tank 5, and a measurement of the quantity of metal. This quantity is compared with the quantity measured before operation. When there is a concordance of results, it is displayed on the display 113 that all the compresses are in the tank 5. Otherwise, the surgeon is alerted so that he performs additional research to find the compress (s) he may have forgotten in the operating site.

It is understood that the metal detector of FIG. 6 comprising means for measuring the phase shift of the signal between the primary circuits and the secondary circuits can be implemented for other applications than the detection or counting of surgical compresses but for metal detection as well as precise measurements of the quantity of metals detected and / or the location of metal parts.

Other embodiments are possible within the scope and scope of the present invention, in particular by changing the shape, the dimensions of the tanks 5, the coils 6, 12 or the probes 13 or by changing the number, the shape or the composition of witness 10, 7, 101, 102 included in the pads 8.

Claims

1. Surgical compresses, characterized in that they comprise an electromagnetic marker comprising a non-magnetic metallic element, in particular a thin metal strip, preferably made of aluminum or an insulated wire, in particular made of copper. 2. Set of surgical compresses, characterized in that each compress comprises a magnetic or electromagnetic marker having identical magnetic or electromagnetic properties, the collective detectable effect of all the markers being equal to the sum of the individual effects of each marker. 3. Device for counting surgical compresses (8) comprising a magnetic or electromagnetic marker, preferably a soft iron element (7), a permanent element (10) or a metallic element, in particular a thin strip (101) or a wire (102) comprising a receptacle, in particular a tank (5) intended to receive the compresses (8) to be counted and means for displaying the number of compresses (8) detected, characterized in that it comprises means for detection of the number of compresses present simultaneously in the receptacle (5). 4. Device according to claim 3, characterized in that it comprises a metal detector making it possible to detect the quantity of metal present in the receptacle (5). 5. Device according to claim 4, characterized in that the metal detector comprises a primary winding (105) supplied with alternating current and a secondary winding (106) placed nearby, preferably around a receptacle (5) of compresses (8) counting and means (107) for measuring the relative phase shift between the signals present in the primary (105) and secondary (106) windings. 6. Device according to claim 5, characterized in that the primary winding and the secondary winding are each connected to a circuit (108, 109) for signal shaping and impedance matching. 7. Device according to claim 5 or 6, characterized in that the metal detector (107) comprises a multipier (110) signals from the primary windings (105) and secondary (106). 8. Device according to claim 5, 6 or 7, characterized in that it comprises a circuit (112) ensuring the scaling and calibration of the relative phase shift between the primary winding (105) and the secondary winding (106). 9. Method for counting surgical pads (8) comprising the steps of: a) placing a magnetic or electromagnetic marker on each pad, b) counting the new pads to be used, c) disposing the used pads count near a magnetic or electromagnetic detector, especially in a tank (5), d) detect and count used compresses, e) display the number of compresses detected, f) compare the number of new compresses counted in step b) with the number of compresses displayed in step d), characterized in that step d) of detection and counting of the pads (8) is a detection of the pads simultaneously present near the electromagnetic detection means, in particular in the tank, at the time of the measurement. 10. Method according to claim 9, characterized in that step d) of counting of compresses (8) is a step of detecting the amount of metal present in the receptacle or the tank (5).