WO2000057783A1

WO2000057783A1 - Intelligent system for the detection of textiles in the field of surgery

Info

Publication number: WO2000057783A1
Application number: PCT/ES2000/000060
Authority: WO
Inventors: Gloria Hermida Borrego; José Antonio LLAMAS LEON; Eduardo DE LA PEÑA CASCON; Marcos Reillo Florkrans
Original assignee: Surgi-Wire, S.L.
Priority date: 1999-03-26
Filing date: 2000-02-22
Publication date: 2000-10-05
Also published as: ES2149729B1; ES2149729A1

Abstract

System for the detection of surgical textiles, and the like and surgical instrument provided with said system to be used in surgery during or at the end of an operation with the aim to detect if, for any reason, textile material remains within the patient before proceeding to the closing of the surgical wound or even once the wound has been closed for verification purposes. The textile material is fabricated with a weft yarn mixture which incorporates the detectable component. It is based on the remote detection of the response generated by certain metal alloys exposed to electromagnetic fields and having predetermined characteristics, making them identifiable explicitly. The detectable component is provided with the characteristics of durability, innocuity, sterilizability, biocompatibility, electric and electromagnetic security, etc., which are necessary for surgical applications. This system is compatible with the X-ray detection without the need for additives.

Description

INTELLIGENT TEXTILE DETECTION SYSTEM WITHIN THE SURGICAL FIELD

SECTOR OF THE TECHNIQUE TO WHICH THE INVENTION REFERS

The invention relates to an intelligent system for detecting textiles, related materials and instruments within the surgical field by means of detectable elements placed in these materials, whose obvious purpose is to easily, safely and effectively achieve the location of textiles (packs, cloths and gauze) and surgical instruments that are necessarily used in surgical interventions.

The aforementioned problem affects textiles, materials and related surgical accessories, as well as the instruments normally used in surgical interventions and which, due to their size, shape, color or position adopted in their use, are likely to be forgotten or lost in the procedure. Operative field during surgery. In this sense, it may happen that material used during the operation remains in the patient's body.

BACKGROUND OF THE INVENTION

Currently there are no means on the market that allow an effective location of compresses and other material used in surgical interventions and that do not pose risks to the patient. The location can only be done when the intervention has finished, but not in the development of it. Consequently, there is no mechanism to detect textiles in the human organism during the operation.

The systems used today are applied after surgery. One of these systems is based on the use of threads containing barium sulfate, a substance Radiopaque detectable by X-rays Thus, when X-rays are applied, the presence of the material containing the aforementioned thread is detected. However, the use of this system has two fundamental drawbacks, namely, in the first place, routine use is not carried out or recommends because of the increased risk of cancer that the use of X radiation would produce in the community, and secondly the radiographic process after the operation unnecessarily prolongs the surgical procedure and the anesthesia time, being precise if surgical material is detected inside , proceed to the descosido and extraction of the same of the body of the patient, which supposes a serious disorder for the people involved and especially for the patient that suffers these inclemencies and increases the risk of surgical complications

Other commonly used procedures consist of counting the compresses that are used or hanging tweezers of a string representing each compress. These means are very primitive and highly exposed to human error. There are even aggravating situations that can alter the count, such as improper packaging of an erroneous number of packs in a package, the complicated interventions that make it necessary to neglect the count to take care of the vital urgency, that any compress or surgical instrument can accompany an excised piece or a newborn, that takes place a turn by turn of staff work during the intervention, or the existence of interventions that predispose to the inadvertent abandonment of surgical textiles (such as laminectomies)

In view of these considerations, it can be affirmed that there is no safe and harmless method that offers guarantees of leaving an operative field free of surgical material

Despite the existence of other inventions and documents that have addressed the problem, none of the solutions they provide have been up to date put on the market, since they involve the use of extremely complex or unreliable techniques, or the definitive placing on the market of the final product becomes difficult due to the high production costs involved However, the invention claimed herein, even based on the response produced by well-known physical phenomena, is distinguished from them in that it has been conceived as a global solution to the problem. That is, the invention described below points to to solve not only the problem of the remote detection of textiles and other surgical instruments, but also provides the industrial solution enabling the implementation in a simple way Industrial applicability is achieved by incorporating the detectable device in the materials and not its addition to the original product, in the case of a new manufactured

Thus, while the other solutions provided consist in the addition to the textile of a device that acted as an element to be detected, in this case we are talking about the incorporation of the detectable element in the same process of formation or manufacture of the textile. a thread that is threaded during the weaving process or at the end of the same according to (fig. 1) or a metal film that covers a flat support or in any other way that is convenient in the fabric manufacturing process

OBJECT OF THE INVENTION

The invention relates to an intelligent textile detection system (compresses, cloths and gauze) and instruments within the surgical field by means of detectable elements placed in the compresses, related textiles and other surgical instruments whose obvious purpose is to achieve in an easy, safe and easy way. effective, the location of these tools that are necessarily used in surgical interventions, and thus solve the problem that arises from involuntary abandonment inside the patient

The estimated incidence of involuntary abandonment of compresses, by far the predominant surgical material, is 1 in 100 to 3,000 interventions. These compresses or gauze can produce a suppurative reaction, behaving in a similar way to an abscess, forcing a surgical intervention to extract the foreign material. On the other hand, it can produce a fibrosis and encapsulation reaction that at best will not cause any discomfort during the whole life of the patient, or on the contrary resemble both a neoplastic process that makes the patient unnecessarily undergo radical oncological surgery

It is known that this problem has been the origin of the failure of organ transplants (these are very prolonged interventions in which staff turnover frequently occurs during the surgical intervention) However, mortality could amount to 20% of the total of abandoned packs

Likewise, this problem causes a huge accumulation of judicial claims that the affected patients file with the medical class requesting, at least, an important compensation for the damages and losses caused. It is estimated that more than 10% of the claims won against doctors are for this concept.

DETAILED DESCRIPTION

This system is based on the adoption as a detectable element of a wire or metallic film (Fig. 2) covered with a film of plastic material harmless to the organism (silicone or te-flon type) in order to protect the patient from internal contact with the thread or film and the loss of eventual metal fragments

The incorporation of the detectable element is carried out in the same textile formation process. A thread is used for this, the description of which will be detailed later, which is threaded during the weaving process or at the end of the same according to (fig. 1) or a metal film that covers a flat support or in any other way that is convenient during manufacturing

The plastic material that covers the detectable element will comply with the corresponding sanitary regulations. Thus, it will avoid the contact of the metallic elements with the organism, so there will be no risk of producing allergies in patients or any other type of complications On the other hand, it will protect the thread from possible breakage and consequently, the reliability of the system will be very high. In addition, the surface characteristics of this material will repel liquids, thereby preventing blood from hiding the original color of the plastic and thereby improving its visual location, with or without enhancing substances such as fluorescent and others. This circumstance helps considerably to those who wish to locate the product, detected or not. The wire or metal film can have a varied diameter between a few thousandths and a few tenths of a millimeter, and its section can be circular or any other that suits the manufacturing system, weaving, positioning or improving its detection characteristics

Its composition is based on a mixture of metals whose electromagnetic characteristics are combined in a way that gives it the property of responding differentiated and specifically to pulses of electromagnetic energy. The form of its response consists of a signal composed of a set of waves, mainly harmonics, that are detectable at a distance by combining an exciter and a receiver in a transceiver that will perform the detection functions referred to below.

This reaction is based mainly on the well-known physical principle of electromagnetic energy induction, considering the detectable element as the induced circuit in the excitation phase and inductive circuit in the response phase, taking advantage of the internal resistance inherent to the metal alloy itself.

The aforementioned alloy may also contain other elements that not yet belonging to the chemical group of metals, can enhance the desired electromagnetic response effect referred to above, either by increasing the response energy, needing less excitation energy, or by responding with a signal whose composition is more easily differentiable. These types of alloys, such as the so-called "Vicalloy", "Arnochrome" and others in continuous research and development process, have long been used successfully in security applications for anti-shoplifting detection in stores for their characteristic response. This demonstrates the reliability of this technique. However, in the case of the invention described herein, even using the same physical principle, it is necessary to use more sophisticated detection techniques that allow the detection of the textile immersed in an adverse environment Thus, the transceiver must have a size that guarantees detection at a certain distance, even in the most unfavorable conditions

The reasons that make us catalog the medium as adverse are. immersion in saline serum and / or blood, diversity of permeabilities between air, water, bone, presence of large metal masses such as the operating table itself, nearby surgical instruments, electromagnetic fields generated by adjacent medical teams, etc. The possibility that there is More than one device forgotten in the operative field must be considered an adverse factor, especially if we take into account that the large antennas, such as those installed in the characteristic stores of this detection system, do not apply in the invention described by obvious reasons, having to resort to the combination of smaller antennas and a more sensitive and sophisticated electronics In addition, the obligation to observe the electrical safety aspects of medical equipment for surgical applications make it necessary to design a transceiver as detailed (fig . 3). The transceiver-detector equipment can be manual or fixed, with analog and / or digital circuits and governed or not by one or several microprocessors. It can also incorporate an incremental gain system in transmission and / or reception, having the possibility of connecting to computers or other peripherals

The transceiver equipment is preferably composed of the circuits or modules described below.

The module (1) is the origin of the operation of the transceiver This module 1 controls the power applied to the coil (2) that generates a magnetic field for the necessary time in order to obtain a polarization or "bias" in the element to be detected , if necessary, depending on the alloy selected and the surrounding conditions The module (3) oscillates by means of a system controlled by a quartz crystal. This oscillation occurs in a precise, stable and continuous way at a frequency that will then be electronically treated in order to obtain the desired value of the same, which we can set a priori at a value less than 1000 MHz

The module (4) has the mission of controlling the phase of the signal generated by the module (3), so that we can obtain the perfect synchronization that may be necessary

The module (5) controls the amplitude of the signal, adapting the level of amplification to the value necessary to obtain the complete excitation of the element to be detected, without reaching the unwanted saturation The amplitude control receives information from the module (6)

The module (6) has the mission of generating the signal with the characteristics of the excitation that we need to respond to the element to be detected, that is Height, connection and disconnection times, repetition value, as well as the pulse morphology itself. For example, module (5) can generate continuous excitation or even pulses containing one or more cycles of the signal originated by (3), depending on the specific needs

The explained combination is delivered to the module (7) This module controls both the impedance adaptation and the "Q" factor of the final stage of the excitation, and is connected to the transmission loop (8)

The result of the process explained is the appropriate excitation of the element to be detected, which will emit the expected response signal and will be received by the receiving loop (9a). This receiving loop (9a) may be composed of one, two or more coils for the purpose of enable "signal differentiation" by (9b) and its location through the corresponding multiplexing by (9c)

The / s signal / is received / s is / are filtered / s in the module (10) eliminating the parasitic signals coming from the radio environment Subsequently, the signal will be amplified by the module (1 1), which will apply the necessary gain factor to get a signal with the appropriate amplitude for the module (12) to process it and adapt it to the needs of the module (13a) This last module is responsible for analyzing the signal and defining whether it matches the expected pattern as a characteristic response of the element to be detected . The characteristic response of said element would be programmable at the factory and even selectable by the user from a group of options preprogrammed in the module (13b). Thus, it is possible to use different improved alloys for the element to be detected.

This selection could also be made automatically by the detector microprocessor by means of a "sweep" of the options in order to find the one best suited for the alloy used at that time. In positive case, it will be sent to the module (14) that controls the microprocessor as fundamental component There, we proceed to inform the user of the result by means of an acoustic tone (15) and another complementary visual indication (16), constituted by deviation of the indicator, message on the screen or simply a confirmation light This information, together with the date and The time may be printed on paper using the optional printer (17), which would provide documentary evidence of having carried out the verification and its result. The paper printing system can be incorporated or external

Special mention the module (18) which acts as a synchronizer, informing the transmitting side when to act and when to rest He does the same part of polarization and co receiving ^'n the multiplexer, preventing if necessary the receiver " listen to "the transmitted signal generating false results and thus enabling the correct operation of the entire system controlled by the microprocessor

As an alternative system, the analysis of the received signal could be used and, after filtering, use methods such as signal subtraction

All of the above is powered by a system of rechargeable batteries (19) or not, offering the necessary guarantee of electrical safety for the patient in the surgical environment Among the tasks of the microprocessor is to dose the transmitted energy by sweeping in an ascending or descending ramp in order to identify if there is an element to be detected in the scanned field The scanning is carried out by successive attempts with different power values and / or parameters of excitation finding coincidence with the pattern of behavior of the element to be detected, selected or programmed in the pattern bank This is an intelligent detection that offers maximum sensitivity with the minimum of false positives

The entire system will bring together the characteristics of reliability, safety and ease of use

The set of transceiver loops can be optimized to be able to share several of the described functions, resulting in a smaller number than the one described, smaller size, or a simpler or more compact arrangement.

The set of transceiver coils, can be arranged in several formats (fig 4) One possibility would be to arrange the coils as a "racket" (4a), solidary or not with the transceiver, which allows free movement over the explored field. it could be arranged as a rigid panel (4b) or as a flexible and waterproof "blanket" that contains them inside for fixed placement in the patient during the intervention. A third format (4c) can have the configuration of the type "curved bar "that by means of a concentration of the focus of the coils it would allow the most precise location of the situation of the element to be detected, after obtaining the positive reading with the normal coil. Another option (4d) would be a curved panel as a" tunnel "on the patient Also, the coils may be configured as fixed to the device or disconnectable

Any of the variants should enable the sterilization or proper cleaning of at least the proximal part or the use of a sterilizable sheath In this sense, the materials selected for the element to be detected allow, without risk, the usual sterilization processes, both industrial and hospital, either by steam, chemical process or by radiation of the product.

The guarantee of correct operation is achieved by the initial automatic check of the transceiver every time it is connected, and the calibration by the user with an element to be detected before starting the intervention using the "CAL" function of the transceiver that will simulate the own losses of intracorporeal application.

In case of doubt or improbable improper operation of the system, being the element to detect a wire or metallic film, it could also be detected using the X-ray system as this material is opaque to said radiation. In addition, it is possible, as another alternative system, to be tracked by ultrasound with an actuation band between 1 '8 and 14 MHz., For example by performing an ultrasound.

Claims

1 Intelligent system for the detection of textiles, related products and surgical instruments within the surgical field, characterized in that it can be used during or at the end of an operation in order to detect if there is any material mentioned inside the patient before proceeding with the closure of the surgical wound or, once it is closed in order to check it without opening it. The detection system is based on a detectable element, of particular characteristics, incorporated in these materials and a transceiver-detector equipment

2 Intelligent textile, related and surgical instrument detection system, according to claim number 1, characterized in that the textile incorporates, in addition to the current and / or specific fibers, one or several films or threads of the metallic alloy to be detected (fig 2), of concrete and determined composition and covered by an innocuous plastic material The thread is threaded during the weaving process or at the end of the same (fig 1) The metal film is applied so that it covers a flat support or in any other way that suits

3 Intelligent system for the detection of textiles, related and surgical instruments within the surgical field according to claim 1 and 2, characterized in that the textile contains the film or wire of the metal alloy to be detected, whether it is woven, on an edge, in a container or bag, or simply housed inside

4 Intelligent textile, related and surgical instrument detection system within the surgical field according to claim 1, characterized in that the metal alloy film or wire to be detected can be added to the surgical material during its production process or after the manufacture thereof; by example by banding, threading, knotting, stapling, encapsulating, gluing, crimping, or any other fixing means

Intelligent textile, related and surgical instrument detection system within the surgical field according to claim 1 whose detectable element is a metal alloy in the form of agglomerable powder in another subject as appropriate

Intelligent system for the detection of textiles, related and surgical instruments within the surgical field according to previous claims, characterized in that the wire or metal film can have a varied diameter between a few thousandths and a few tenths of a millimeter, and its section can be circular or any other It is convenient and is coated on the outside of plastic or elastic material harmless to the body to protect the inner thread or film from contact with the body environment and the loss of any metallic fragments This plastic material will repel liquids improving visual location with or without enhancer substances such as fluorescent or others, and may be subject to different treatments for the best fixation, manufacture, duration, resistance to external agents, and sterilization

Intelligent textile, related and surgical instrument detection system, according to previous claims, characterized in that the metal alloy has electromagnetic characteristics that allow it to respond in a differentiated and specific way to pulses of electromagnetic energy emitted by the transceiver-detector equipment The aforementioned alloy can contain other elements that not yet belonging to the chemical group of metals, can enhance the effect of the electromagnetic response It can be added with substances that combine its electromagnetic response with others such as opacity to X-rays, and / or detection by other means such as ultrasound The aforementioned alloy reacts by retransmitting a specific signal whose content identifies the composition of the material Intelligent textile, related and surgical instrument detection system, according to claim 1, characterized in that the warning of the detector equipment can be visual and / or acoustic, with the possibility of printing the test results together with the date and time of the same as well as other intervention data

Intelligent textile, related and surgical instrument detection system according to claims 1 and 8, characterized in that the detector equipment has a set of excitation-polarization, transmission and reception coils that can be configured as fixed to the equipment or disconnectable, this being last complementary possibility with a range of loops for different applications

Intelligent textile, related and surgical instrument detection system according to claims 1, 8 and 9, characterized in that the detector equipment can be manual or fixed, with analog and / or digital circuits and governed or not by one or more microprocessors It can incorporate a Incremental gain system in transmission and / or reception The paper printing system can be incorporated or external, and the warning form by means of a screen, pilot light, needle indicator or similar, can incorporate acoustic indication of detection as well as other functions , including system error You can have communication with computers or other peripherals You can have a range of antennas adapted to specific applications

Intelligent textile, related and surgical instrument detection system according to claims 1, 8, 9 and 10 characterized in that the metal wire or film detector equipment is preferably composed of the circuits or modules described below as the module of origin of the operation of the transceiver and power controller (1), coil (2) that generates a magnetic field for the necessary time in order to obtain a polarization or "bias" in the element to be detected, module that oscillates (3) by a controlled system by a quartz crystal in a precise, stable and continuous way at a frequency that will later be electronically treated in order to obtain the desired value thereof, which we can set a priori at a value below 1000 MHz; module that controls the phase of the generated signal (4), module that controls the amplitude of the signal (5), adapting the amplification level to the value necessary to obtain the complete excitation of the element to be detected, without reaching the unwanted saturation . The module (6) generates the signal with the characteristics of the excitation that we need to respond to the element to be detected; module that controls both the adaptation of the impedances and the "Q" factor of the final stage of the excitation (7) and is connected to the transmission loop (8). The result of the process explained is the adequate excitation of the element to be detected, which will emit the expected response signal and will be received by the receiving loop (9a), the module (10) filters the signal / s received. The module (11) amplifies the signal, and another module that processes it and adapts it (12) to the needs of the module (13a) which analyzes the signal and defines whether it matches the expected pattern as a characteristic response of the element to be detected. The characteristic response of said element would be factory programmable and even user selectable from a group of options preprogrammed in the module (13b). In this way, it is possible to use different improved alloys for the element to be detected.

12. Intelligent textile, related and surgical instrument detection system according to claim 1, characterized in that the receiving loop of the detecting equipment may be composed of one, two or more coils in order to enable "signal differentiation" and its location through the corresponding multiplexing.

13. Intelligent textile, related and surgical instrument detection system according to claims 1, 8, 9, 10, 1, and 12 characterized in that the metal wire or film detector equipment could automatically select the signal by the microprocessor which incorporates through a "sweep" of the options in order to find the best adapted for the alloy used at that time. If positive, it will be sent to a module where the microprocessor is located and informs the user of the result. Intelligent textile, related and surgical instrument detection system according to claims 1, 8, 9, 10, 11, 12 and 13 characterized in that the metal wire or film detector equipment includes a module that acts as a synchronizer, informing the transmitting party when to act and when to rest Do the same with the polarization part and the receiver with its multiplexer, preventing the receiver from "listening" to the transmitted signal generating false results All of the above is powered by a rechargeable battery system or not, offering the necessary guarantee of electrical safety for the patient in the surgical environment

Intelligent textile, related and surgical instrument detection system according to claims 1, 8, 9, 10, 1 1, 12, 13 and 14 characterized in that the microprocessor of the metal wire or film detecting equipment dosages the transmitted energy by scanning ascending or descending ramp in order to identify if there is an element to be detected in the scanned field The scan is carried out by successive attempts with different power values and / or excitation parameters finding a match with the behavior pattern of the element to be detected, selected or programmed in the pattern bank

Intelligent textile, related and surgical instrument detection system according to claims 1, 8, 9, 10, 1 1, 12, 13, 14 and 15 characterized in that the metal wire or film detecting device may arrange the transceiver coil assembly in several formats (4) One possibility would be to arrange the coils as a "racket" in solidarity or not with the transceiver that allows free movement over the scanned field, or as a rigid and even flexible and waterproof "blanket" that contains them in inside for fixed placement in the patient during the intervention A third format can have the type configuration

"curved bar", which would enable a more precise location of the coils to be concentrated after the positive reading with the normal coil was obtained

Another option would be a curved panel as a "tunnel" on the patient. Any of the variants should allow the sterilization or proper cleaning of at least the proximal part or the use of a sterilizable sheath.