EP2701627A1

EP2701627A1 - Medical device provided with an innovative marking system enabling rapid, repeated and remote identification

Info

Publication number: EP2701627A1
Application number: EP12722466.5A
Authority: EP
Inventors: Marc Antoine SERGEANT
Original assignee: Individual
Current assignee: Individual
Priority date: 2011-04-26
Filing date: 2012-04-24
Publication date: 2014-03-05
Also published as: FR2974496A1; US20140088570A1; FR2974496B1; WO2012146867A1

Abstract

The invention relates to a medical device comprising a reusable or non-reusable surgical instrument made from metal, polymer or plastic, or any implant or prosthesis substitute made from metal, polymer or plastic, which is equipped with a marking system enabling rapid identification of the instrument. The marking system comprises: an RFID component called a "tag"; and a resin protuberance which is rigidly connected to the surgical instrument or implant substitute to be marked, said protuberance containing, and completely surrounding the tag.

Description

Medical device with an innovative marking system, allowing quick, multiple and remote identification.

The present invention relates to the field of remote identification of reusable medical equipment. The present invention more particularly proposes a system for integrating an identification component, of the RFID component type, in a resin protuberance, on a reusable metal, polymer or plastic surgical instrument. This present invention may also be declined for implant substitutes or metal prostheses, plastic or polymer.

The conclusion is simple: the number of deaths related to nosocomial infections remains significant for several years, the various current measures are not sufficient to drastically reduce this rate, more in a perspective of cost reduction private health facilities, public are looking for ways to optimize their management. The sterilization of health facilities, where the instruments are cleaned and sterilized, as well as the operating theaters, are areas where significant progress can be made. The skilled person knows that an effective solution, allowing a reduction of costs but also allowing a better risk management, is traceability to the surgical instrument. Surgical instruments will be discussed here, but all that we will mention will be applicable to implant and prosthetic substitutes as well as any reusable medical equipment, where traceability to the element is interesting.

The skilled person knows that a simple traceability to remotely identify an instrument, record and update any useful information on the instrument, for example, its serial number, the clinical history of patients operated, usage, maintenance, and sterilization specifications, as well as remotely identifying multiple instruments, offers financial benefits, but also facilitates risk management. It allows first of all to give a characteristic name to an instrument, as well as a date of purchase, which makes it possible to make use of manufacturer's guarantees, action can not be realized without identification of the instrument.

In addition, a recent study has revealed that more than one in three operational incidents is due to poor management of surgical instruments, this being due to first, the stress of surgeons and nurses, most often caused by poor management of surgical instruments. By performing a traceability to the instrument, it allows to acquire the certainty that a box of instruments is complete. Thus, we know directly if all the instruments at the entrance of the operating theater are present in the box. Indeed, the recurring problems are incomplete or poorly constituted boxes.

The number of nosocomial infections contracted in the operating room is significant. A good way to reduce this risk, in addition to the usual constraints on safety in blocks (white areas), is to trace the instrument. With traceability, we can be sure that the instrument will have followed the sterilization steps. Moreover, this technology makes it possible to certify that all marked instruments have followed the entire sterilization process, and also not to confuse single-use instruments with reusable instruments. Many cases of fraud have been detected in hospitals, which could lead to an increased risk of patient contamination. Recent cases, such as that of the Sport Clinic, have shown the importance of rigor in the sterilization cycles of the surgical instruments used. In this case, more than 1300 patients were affected by Xenopi bacteria. Such fraud would not have been possible where the instruments had been identified and certified by traceability.

At the legal level several regulations have emerged since 2001 concerning the traceability of instruments in France. In 2001 the circular DGS / 5 C / DHOS / E 2 n ° 2001 -138 of March 14, 2001 relates to the precautions to be observed during care to reduce the risks of transmission of unconventional transmissible agents. In this circular a first mention appears in relation to the traceability of the instruments specifying that the establishment must make every effort to facilitate the traceability of the surgical instrument in case of problem. Other circulars followed in 2009 to arrive at the WHO checklist which requires the counting of instruments before and after surgery, and there can be up to 500 instruments per operation, which creates an obvious loss of time. . Traceability to the instrument would facilitate this step, and especially avoid human errors that can be important here.

Hospitals are criminally responsible for the acts performed. As an example, the AP-HP receives 1,200 annual complaints concerning medical errors or bad patient care as well as infections. within the hospital. Better traceability of surgical instruments is the best way for hospitals to guard against some of these legal procedures.

Legislation on the prion requires being able to find the last patients operated with a medical device used in the patient with whom a risk of infection was found. Such recognition is possible only if one can trace the instruments one by one.

An incomplete or incorrect box arriving at the block is a real waste of time. It is immediately returned to the sterilization zone. As a result, the instruments in the box are thus re-submitted to the entire sterilization process. Traceability to the instrument makes it possible to know with certainty the presence of the instruments in a box, whether at the sterilization outlet or at the entrance to the operating room. This avoids the presence of non-compliant boxes at the entrance of the operating room, and thus avoid the loss of time in the planning of operations, and also significantly reduce the number of laps of sterilization performed unnecessarily.

The management of human resources and the allocation of their tasks remains a major problem in hospital structures. Now, the constitution of boxes, their preparation in block, etc. are responsibilities of the block nurses, functions currently lacking staff. Identification with the instrument would free the nurses from these time-consuming procedures to delegate them to sterilization operators who will only have to present the instruments in front of a detector, the software indicating them the box corresponding to each of the instruments .

This traceability to the supply instrument is a valuable aid to the maintenance, the management of stocks and expired in the instrumentation park and to recompose the instrument trays for the operating theaters during their reprocessing.

In the prior art there are several traceability systems to the instrument. First of all, it is observed that in a certain number of establishments, the identification is done visually, one recognizes a type of instrument, and not an instrument in particular, by comparing it to a photograph, moreover in respect of the law, the instruments are counted at the entrance and exit of the block. This process is only visual, the errors are numerous, and some financial optimization actions are impossible: the realization of a complete inventory, the management of the renewal and maintenance of the instrument fleet, the fight against theft or the loss of instruments, the reduction in the number of unnecessary sterilization lapses, or the management of human resources.

Another solution is to carry out a color marking of the surgical instruments, in particular described in the patent application FR2760630A1, in this document it is planned to machine, in one or more places, the surgical instrument for affix color markers. By creating color combinations, the operator can identify the instruments and store them in their respective boxes. This invention despite a reduced cost advantage is very limited and has some weaknesses. Indeed the number of instrument being important, the number of color combination will have to be too high, an operator will not be able to memorize them, and it will be forced to refer to a document making him waste a precious time with regard to the amount of instrument to store. Always linked to the increasing number of instruments and the resulting multiple color combinations, the instrument will have to be machined in several places which will weaken the structure of the instrument, and will increase the risk of loss of the color marker, for example in the body of a patient. In addition, this solution has no financial advantage, it does not allow automation of part of the identification, management gain, time or security.

The European patent number EP0681252A1, proposes a solution of traceability to the instrument similar to the identification by bar code, this technology is more commonly called "datamatrix" or barcode in two dimensions. This solution proposes to laser mark the surgical instruments, by engraving on a part of the instrument a two-dimensional barcode, this code containing a certain amount of information. As for the classic bar code, the identification must be done at short distance by visual detection. Any opaque element between the reader and the marked part of the instrument prevents the reading of the code. The advantage of this technique is that it can be expensive and more efficient from a time-saving point of view than color marking solutions. Nevertheless, several major imperfections go against the democratization of this method: the presence of water between the barcode and the detector makes it impossible to read, but in sterilization the instruments are either wet or dirty, under these conditions the operator must look for the location of the barcode and then wash and dry the area before reading this code. The Datamatrix does not save time or multiple or remote identification. The engraving of the instrument also has many disadvantages. Two possibilities exist: deep laser marking of the instrument or a superficial barcode. In the first case, the marking creates a significant roughness on the surface of the instrument and constitutes a zone of significant risk in the deposit of infectious elements, while weakening the structure of the instrument. In the second case, the marking disappears easily and must be repeated often.

A more interesting solution is disclosed in the French patent number FR2935602A1, as well as in similar forms in the US Pat. No. 3,737,684B2, the French patent FR2947713A1, or the European patent EP21 16208A1, this solution recommends machining the surgical instrument for use therein. introduce a remote identification tag, better known as RFID tag (Radio-frequency-identification). Radio identification, more often referred to as Radio Frequency Identification (RFID), is a method for remotely storing and retrieving data using markers called "RFID tags", "RFID tags" or "RFID transponders". ". The purpose of this solution is to dig on the instrument a housing for receiving inside the transponder, or RFID tag, and close it with the help of either a material identical to the composition of the instrument, or with the help of an element allowing the radio waves to pass. This technology has significant advantages, such as the robustness of the support to the environment, the information storage capacity inside the chip, the ease of reading in an unsuitable environment. The traceability to the instrument is only interesting when it verifies the following properties: individual identification of the instruments fast, inexpensive with regard to the unit cost of an instrument and in conformity with the requirements of sanitary security present in a hospital environment. As part of the solution described in the patents mentioned above, machining each instrument and incorporating small tags represents a considerable work time and is extremely expensive. In addition, this causes a significant weakening of the instrument. The effectiveness of the RFID action is also reduced: the integration of a high-frequency tag in a metal cavity causes disturbances, both emissions and the reception of electromagnetic waves, due to the known phenomenon of Faraday cage for the case of metal instruments. The performance of the system is greatly altered: reduced reading distance to contact and use of more expensive detection equipment. A solution to overcome the problem of wave disturbance by the instrument could be to use low-frequency RFID tags. Nevertheless, the performance of the overall system will not be improved, the detection of the instruments should then be performed individually and the reading time would be significantly longer because of the turn-on and turn-off periods of the RFID tag chip circuit. In addition, in order to use this technology, the necessary detectors must emit a concentric magnetic field, imposing a reading distance to contact and very high investments.

A last solution, much closer to that previously described, is proposed by the French company IS-Medical in its patent application number FR2868393A1 dated 14/04/04. The company also proposes to integrate RFID tags to surgical instruments but here it recommends to enclose the tag in a metal capsule and solder this capsule to the instrument. As part of this solution, the advantages exist: the robustness of the association between the RFID tag and the surgical instrument, the reliability of the link between the support and the instrument, the important information storage capacity of the chip, and the possibility of use in a degraded environment, but the financial and technical constraints of weakening the instrument remain unchanged. This case is similar to that previously mentioned, the integration of an RFID tag in a metal cavity implies the requirement to use low frequency RFID tags. Also, the technical tests showed that the use of a concentric field of the emitter is necessary, and consequently imposed also a reading with the contact and individual of the instruments. Moreover, as previously, the use of small chip, and the method of integration entail costs, although lower than the previous solution, remain always important.

The present invention aims to overcome many of the disadvantages of the prior art, it proposes to allow traceability of a metal surgery instrument, polymer or plastic, reusable or not, using a system of reading ; this present invention may also be declined for implant substitutes or metal prostheses, plastic or polymer, dental or veterinary instruments. In the remainder of the document, the term "element to be marked" means any type of metal surgical instrument, made of polymer, plastic, reusable or not, implant substitutes, metal prostheses, plastic or polymer, dental or veterinary instruments.

The present invention wants to be able to respond to the problems mentioned above, problems encountered in sterilization, and plateau at the limits of existing techniques. To this end, the invention relates to an innovative technique for integrating an identification element into a protrusion on a surgical instrument or on another element to be identified.

The present invention is resistant in time, have a lifetime equivalent to that of the elements to be marked, it is cheap, in order to provide a maximum of elements to mark, is easily used: easy detection, multiple and remote, wants to be secure, with no roughness that can cause the presence of infectious agent, and finally resistant to the environment of sterilization.

To achieve this goal, the invention will use RFID technology, identified by those skilled in the art, as the most likely to answer questions of safety, simplicity and cost management in sterilization. The transponder or tag comprises a microprocessor, a memory, an analog input interface and an antenna. A transponder is linked to the element to be marked, as will be shown by the present invention, to ensure rapid identification of the appropriate element, by detecting this transponder remotely by a suitable reading system. The system is connected with a computer system for retrieving information related to the element to be marked, in some via a database. Also, the advantages of this technology are an important information storage, a fast and multiple reading. The difficulty of the present invention lies in the association of the RFID tag with the element to be marked.

The advantages of using an RFID tag, or transponder, for the present invention are numerous, the person skilled in the art will easily identify the potential of this technology coupled with the present invention, here is a set of illustration of these advantages, This list is not exhaustive ; the use of the invention should not be limited to the only examples presented below. The use of an RFID tag or transponder in the present invention has, inter alia, the purpose of linking each patient to all the instruments used during his operation, and each instrument to all the patients for whom he will have used, to verify that an instrument has followed all the steps of sterilization by automatic or manual detection at each stage of sterilization, in the case of non-compliance with these steps the instrument must be able to be located and removed from the cycle , to quantify the number of cycles of sterilization cycles and operations that the instrument will have performed, to know its date of purchase in order to ability to use manufacturer's warranties. Another advantage of this technology is that it is sometimes used in sterilization for the detection of instrument containers, boxes or bags, which allows an adaptation of the systems already in place.

The invention is characterized in that the transponder, or RFID tag, is integrated in a protrusion, or housing, of specific material, said housing being integrated in the element to be marked so that no part of the said transponder is too close to the element to be marked. The present invention relates to a medical device reusable or not, characterized in that it comprises:

A protuberance of material allowing the electromagnetic waves, integral with said medical device, to pass through, at least partially,

An electronic chip responding to radio frequencies inserted entirely or partially into said protuberance.

In the rest of the document will be designated under "tag", any type of RFID component such as said transponder, or RFID tag, or RFID chip, or electronic chip, or radio tag. The characteristic positioning of the said tag on the outside of the element to be marked in a non-conductive material which, associated or not with an insulator, makes it possible to limit the effects of the Faraday cage in the case of metal marking elements. , which facilitates the transfer of remote information between the reader and the tag, this feature is the innovation of the present invention is the original approach of this solution.

The invention is characterized in that said material is a resin. Several large families of resins may correspond to the objectives of the present invention: epoxy type resins, polyamides, polycarbonates, polystyrenes, polyethylenes, polypropylenes, acrylonitriles, butadienes, styrenes, acrylics, polyurethanes, nylons. Advantageously we will move, in the following document to the epoxy type resins. This resin will be more particularly an EPOXY resin, two-component, high thermal stability and resistant to the effects of water for plastic-metal compatible substrates, meeting medical standards. It should be obvious to those skilled in the art that the present invention allows embodiments in many other specific forms, using different resins for different applications, without moving it away from the scope of the application. invention. Therefore, the present embodiments should be considered as illustration, and the invention should not be limited to the single resin shown below.

These two-component EPOXY adhesives develop high resistance to the chemical agents used in prewash, but also to tensile and shear effects on a wide variety of plastics and metals. The polymerization of the resin-hardener couple creates a cohesive thermosetting plastic with good chemical and thermal resistance. When integrated and used, the resin has the characteristic of having a limited shrinkage effect. Their final structure must have the characteristic of being completely homogeneous, and in particular without air bubbles, so as not to degrade their mechanical resistance, but also without any roughness on their surface in order to verify the health prerogatives imposed by the supervisory authorities. .

The inventor has determined that this particular type of material responds to the thermal, chemical and mechanical stresses for the binding of the tag and of an element to be marked and has an adverse surface state to the deposits.

The integration of the resin with the element to be marked can be carried out according to two particular methods: one by molding in the case of a liquid or solid resin, the other by bonding in the case of a pasty resin with said element to mark. The process by bonding involves a preliminary preparation of the resin used: the said resin is pre-cut and in some cases formed to accommodate the tag, the cut will accommodate the marking portion of said element to be marked. The tag will be embedded in the resin.

According to particular embodiments said tag can be integrated directly with said resin to the element to be marked, this integration to the element can be done either by molding, or by gluing, or by any other method of resin bonding on metal, according to a particular process.

According to other particular embodiments, said protuberance is first integrated into the element to be marked, this protuberance having a hollow zone of the shape of said tag with additional space for closure, this integration of the protuberance the element can be made either by molding, in the case of a liquid or solid resin with a mold having the expected shape and the housing required to receive the tag either by gluing, in the case of a resin pasty, by precut of the expected shape and the housing of the tag, or by any other method of bonding resins on metal, this according to a particular procedure. The said tag will then be positioned in the space left vacant in the said protuberance, and a lid, of the same composition as the said protrusion, will be placed on the said tag to close the opening. Said cover may be ultrasonically welded using a sonotrode, the protuberance, according to a particular method. According to another feature, said cover is glued to the body of the protuberance so as to ensure the tightness of the housing. The welding or gluing of the lid makes it possible to ensure continuity between the surface of the protuberance and the lid, in order to guarantee the tightness of the housing of said tag. According to other particular embodiments, said protuberance is first integrated into the element to be marked, this protuberance does not have a hollow zone, this integration of the protuberance with the element can be done either by molding, in the case of a liquid or solid resin with a mold having the expected shape, either by gluing, in the case of a pasty resin, by precutting the expected shape, or by any other method of bonding resins to metal, this according to a particular method. A housing allowing the integration of said tag and a lid is then machined, according to a particular method, the positioning of said tag defined on the protuberance. The said tag will then be positioned in the space left vacant in the said protuberance, then a lid, of the same composition as the said protuberance, will be placed on the said tag to close the opening. Said cover may be ultrasonically welded using a sonotrode to the protuberance, according to a particular method. According to another feature, said cover is glued to the body of the protuberance so as to ensure the tightness of the housing. The welding or gluing of the cover, ensures a continuity between the surface of the protuberance and the cover.

According to another feature, the diameter and the depth of the housing formed by the machining are substantially greater than the diameter and the depth of said tag and said cover so that said tag is positioned in a housing equidistant parts upper planes of the protuberance when the lid is welded or glued to the body of the element to be marked.

According to another particularity, it will be advisable to leave a minimum distance of at least 1 mm between the tag and the instrument, space filled by the resin, and a sufficient distance of material between the tag is the outside so that the latter is totally isolated in the resin protuberance, to ensure the protection of said tag, the strength of said protrusion, and to limit disturbances caused by other metal elements in the vicinity of the protuberance during identification.

For this invention several possibilities of tags may be proposed according to the expected applications of the invention, by the skilled person.

A goal is achieved by proposing a use of an element to be marked according to the invention, characterized in that the tag is a passive tag in the case where the user wants an inexpensive solution.

Another object is achieved by proposing a use of an element to be marked according to the invention, characterized in that the tag is an active tag, if the user wants a solution that takes into account more information, and offers possibilities wider operation.

Another purpose is achieved by proposing a use of an element to be marked according to the invention, characterized in that the tag is a tag in simple read mode, if only the code of the instrument and some fixed information interest the user. .

Another purpose is achieved by proposing a use of an element to be marked according to the invention, characterized in that the tag is a tag in read and write mode, in the case where the user wants a solution allowing him to register. the information also collected on the memory of the tag, so on the element to be marked.

Another object is achieved by proposing a use of an element to be marked according to the invention, characterized in that the tag is a low frequency tag, having little disturbance related to metals or to the human body, but a reading speed more low therefore a multiple reading of element to mark more difficult.

Another object is achieved by proposing a use of an element to be marked according to the invention, characterized in that the tag is a high frequency or ultra high frequency tag allowing a fast and therefore multiple reading. For HF and UHF tags, the present solution makes it possible to reduce the faraday cage effects linked to the metal of the element to be marked, by positioning the tag away from the element to be marked.

It should be obvious to those skilled in the art that the present invention allows embodiments in many other specific forms, by incorporating different tags for different applications, without moving it away from the scope of the application. invention. Therefore the presents Embodiments should be considered by way of illustration, and the invention should not be limited to the only tags presented above.

According to another particularity, the tag used for the present invention may be encapsulated in a structure before being integrated directly into said material. According to another particularity, the tag can be directly integrated with said material without having been previously enclosed in a protective structure.

The invention is characterized in that the resin protuberance containing the tag is integrated in the element to be marked so that its position is in no way annoying for optimal use by the user, nor for the implementation of a handle.

According to another feature, the shape of the protuberance can be adapted to the expectations of the nursing staff, while assuming that the optimal shape remains that which we will present during the explanatory description, this form having the purpose of disturbing at least the grip of the patient. 'user. Thanks to these devices, the link between the chip and the reusable marking element is, at the same time, highly resistant to mechanical shock, to aggressive environments, especially to chemical cleaning agents, said resin protuberance serving to protect the said tag, and sufficiently flexible to withstand the different thermal expansions of the chip and the reusable medical device. In addition, the fact that the chip is present at a minimum distance from the element to be marked metallic the effects of disturbance of the element on the waves are reduced, the fact of using an EPOXY resin material causes that the risks of deposits are limited or non-existent.

Other objects, features, details and advantages of the present invention will appear more clearly in the course of the description which follows, description made for an explanatory and non-limiting purpose, with reference to the appended figures given by way of non-limiting example in which:

FIG. 1 illustrates the use of a marked surgical instrument with the aid of the present invention, cooperating with a reading system associated with a computer system.

FIG. 2A represents a top view of a surgical instrument, such as an iliac clamp, on which the resin protuberance has been integrated. comprising the RFID component, which is said tag, on one of the chisel rings, and an enlarged top view of this marked ring.

FIG. 2B represents a top view of a surgical instrument, such as an iliac clamp, on which has been integrated the resin protrusion containing the RFID component on one of the rings, and a protuberance of different shape on the other ring, protuberance not normally comprising RFID component.

FIG. 3A represents a top view of a surgical instrument, such as the needle holder, on which the resin protuberance comprising the RFID component, which is said tag, has been integrated on one of the chisel rings.

FIG. 3B represents a top view of a surgical instrument, such as the needle holder, on which the resin protrusion containing the RFID component on one of the rings has been integrated, as well as a protuberance of different shape on the other ring, protuberance not normally comprising RFID component.

Figure 4 shows a top view of a surgical instrument, such as a clamp called "PAD Cushing", on which was integrated the resin protrusion containing the RFID component, which can be seen by transparency.

FIG. 5 represents a top view of a surgical instrument, such as a scalpel, the blade having been dotted, the solid line handle on which the resin protuberance containing the RFID component has been integrated, which can be seen by transparency.

FIG. 6A is a longitudinal sectional view of the marked rings of the instruments represented in FIGS. 2A, 2B, 3A, 3B, it makes it possible to visualize the inside of the protuberance, and also to see by transparency the RFID component. This figure represents a mode of integration of the protuberance and the RFID component, the instrument.

FIG. 6B is a longitudinal sectional view of the marked rings of the instruments represented in FIGS. 2A, 2B, 3A, 3B, it makes it possible to visualize the inside of the protuberance, and also to see by transparency the RFID component. This figure represents another mode of integration of the protuberance, and the RFID component, to the instrument.

FIG. 7 is a plan view of a substitute implant or prosthesis made of polymer or plastic, which is here a tibial prosthesis, on which has incorporated a resin protrusion comprising an RFID component. An enlarged sectional view of this protuberance has also been added, it can be seen by transparency the RFID component.

Throughout the description, medical devices such as reusable metal surgery instruments, or a polymer prosthesis substitute will be presented, however, the scope of the present invention is not limited to this type of reusable medical device.

In general, the medical device according to the invention comprises a reusable surgical instrument or not of metal, or polymer or plastic, or any substitute implant or prosthesis metal, polymer or plastic, provided with a marking system for rapid identification of the instrument. The marking system comprises:

an RFID component commonly known as a "tag", and

a resin protuberance integral with the surgical instrument or the implant substitute to be marked, the protuberance completely containing and surrounding the tag, the resin thickness surrounding the tag being, for example, greater than or equal to 1 mm.

Advantageously, the resin of the protuberance is an EPOXY type resin.

In one embodiment, the protuberance incorporating the tag is fixed on the surgical instrument or on the implant substitute to be marked in a location corresponding to a portion forming a gripping means of the instrument. It should be noted that the portion of the protuberance attached to the surgical instrument or the implant substitute to be marked marries the shape of the instrument or the implant substitute. In addition, the medical device according to the invention may comprise at least one additional protuberance, the latter being adapted to balance the surgical instrument or the implant substitute. In addition, this additional protuberance may contain a tag.

In different embodiments, at least one protuberance:

contains at least two tags, the at least two tags being oriented in different directions,

- contains an opaque radio element,

- is color-coded to identify the medical device. In one embodiment, radiofrequency insulation is disposed between the instrument or the implant substitute to be marked and the protuberance.

Advantageously, the surgical instrument 103, 201, 21 1, 301, 31 1, 401, 501, 701, equipped with an RFID component 202, 212, 302, 312, 404, 503, 604, 615, 703 enabling its remote identification makes it possible to improve the monitoring of said instrument, its traceability within the establishment, as well as in certain cases its traceability between different health establishments, also improves the management of said instrument, by associating it for example with the patient operated, inventory management and inventories, this list is not exhaustive.

With reference to the figures the invention proposes to add to a metal surgical instrument, in polymer or plastic, or on an implant or prosthesis substitute 103, 201, 21 1, 301, 31 1, 401, 501, 701, a protrusion of material allowing the electromagnetic waves to pass, here more particularly a resin, 104, 203, 213, 303, 313, 402, 504, 603, 613, 702, in which there is an RFID component 202, 212, 302 , 312, 404, 503, 604, 615, 703. In the remainder of the description the term "surgical instrument" should be taken without limitation. This term may include reusable or non-reusable surgical instruments, made of metal, polymer or plastic, or an instrument in part of one, implant or prosthetic substitutes, dental or veterinary instruments. The instruments presented in the diagrams are to be taken as an example.

In the remainder of the description we will speak of tag in a non-limiting way, the term "tag" will include any type of RFID component. These RFID components may be previously encapsulated in a protection structure, or may be naked tags. For the sake of clarity, a circular tag of conventional size, with a diameter of one to two millimeters, and a height of approximately half a millimeter, will be used as the basis of the illustrations. The present descriptions and examples proposed should be considered by way of illustration, but may be modified by the expectations of the user, the invention should not be limited to the details given above.

The surgical instrument shown in the example of Figure 2A, is an iliac clamp 201, which is an instrument for example to expand a natural cavity to facilitate examination and possibly introduce an instrument. In this example the location of the protrusion 203 of resin is provided on one of the two rings of the chisel 204. The said tag 202 being enclosed within this protuberance.

Figure 3A shows a second example of a surgical instrument marked with the present invention, the illustrated instrument is a needle holder 301 which is an instrument used by surgeons to more easily handle suturing needles. In this example the location of the protrusion 303 of resin is provided on one of the two rings of the chisel. The said tag 302 being enclosed within this protuberance. In these examples, the protrusion 203, 303 has an elliptical portion in which the tag 202, 302, the portion attached to the ring 204 comes to marry the shape of said ring 204, so as not to disturb the grip of the chisel 201 , 301 by the surgeon. The half-ellipse shape containing the tag 202, 302 also makes it possible to disturb the grip of the instrument 201, 301 as much as possible by the surgeon, this shape makes it possible to espouse the shape of the instrument and the tag in order to limit the size of the protuberance, but also to limit its weight. The main advantage of this invention is that the positioning of the tag within the protrusion is such that the disturbances on the information transmissions by waves, due to metal instruments, are limited. In addition, the structure of the instrument is not modified, the instrument is not machined, which limits marking costs, as well as the risk of weakening of the structure of the instrument.

It should be noted that the protuberance 203, 303 is disposed in the continuity of the instrument to be marked so that the junction between the protuberance 203, 303 and the instrument to be marked does not have any recess (fault), such a junction prohibiting the deposition (the nesting) of bacteria between the protuberance 203, 303 and the instrument to be marked.

Alternatively, the protrusion may be on another portion of the instrument and have a different shape, it will depend on the expectations of the user, the present invention is not limited to the applications proposed by this description, we can place a protuberance of different shape on the ring, or on the junction zone between the two parts of the ring; nevertheless this type of instrument being invasive, it is then necessary that the part of the instrument in contact with the patient keeps its original shape, the protuberance should not be on these parts. The advantages of positioning, and shape proposed in this example, are that the shape comes to marry the shape of the ring, without causing great disruption for the surgeon.

The protuberance 203, 303 will advantageously be EPOXY resin, with high thermal stability for substrates compatible with metal plastic, to medical standards, these EPOXY components develop a high resistance to prewash, tensile and shear on a wide variety of plastics and metals. They polymerize to make a cohesive thermosetting plastic with good thermal and chemical resistance, they cause a small shrinkage. This particular type of material responds to the thermal, chemical and mechanical stresses for the binding of the tag and a reusable surgical instrument and has a surface condition unfavorable to the deposits. This resin may be integrated in liquid form, solid, or advantageously in the form of paste.

The use of a resin as a material gives the protuberance 203, 303 considerable resistance to the aggressive conditions of the sterilization cycles.

In an advantageous embodiment of the invention, the resin used for the protuberance 203, 303 is biocompatible.

Passive tags, here 202, 302 cylindrical are known to those skilled in the art for their use for object markings, these tags are composed of an electrical circuit with two plugs on which are welded a coil formed of a wire wound on a ferrite core.

The present invention provides a use of the marked surgical instruments as described in FIG. The surgical instruments 103 marked with the present invention 104 is here grouped on a plate 102, this description being an illustration of the use of the invention it is not limiting. Reading / writing of the tags present in the protuberances 104 of the surgical instruments 103 is performed using the tag antenna formed by the annular winding capable of transmitting and receiving a radio frequency signal containing information, a computer software 101 will allow interfacing between the user and the data stored on the tags, as well as on a database 107 automatically coupled to the detection of marked surgical instruments. A transmitter / receiver 105 will make the communication between the instruments and the software, the software linking it to the database 107 and the user. This transmitter / receiver 105 emits an electromagnetic field 106 containing the information is that field 106 which will allow the information to be deposited between the tag of the surgical instrument 103 and the software 101.

The use of the present invention as marking of a surgical instrument, present in its use, a step of reading the information contained in the tag located in the protrusion 104 by means of the reading system 105, the transmission of this information to the software that interfaces with the user 101 and the database 107, a step of transmission of the data by the software to the user, as well as an update of the database 107. The traceability data related to the surgical instrument, stored in the database 107 can be changed as and when the identification of the surgical instrument 103, automatically by the software or manual by the user, these functions will be adapted at the convenience of the user.

Other examples of labeling using the present invention are shown in FIGS. 4 and 5. FIG. 4 shows a surgical instrument 401, more specifically a "Cushing" forceps 401 assisting the surgeon in the dissection, the figure 5 it presents as a surgical instrument a scalpel 501. In this example, the location of the protuberance 402, 504 of resin is provided at the bottom of the surgical instruments, in the continuity of the surgical instruments. The said tag 404, 503 being locked inside this protuberance. In these examples, the protuberance 402, 504 has an elliptical portion in which is located the tag 404, 503, the part attached to the lower part of the surgical instrument 403, 502 comes to follow the shape of said surgical instrument 403, 502, so as not to disturb the grip of the surgical instruments 401, 501 by the surgeon. The half-ellipse shape containing the tag 404, 503 also makes it possible to disturb the grip of the surgical instrument 401, 501 by the surgeon at least, this shape makes it possible to espouse the shape of the surgical instrument 403 and the tag to limit the size of the protuberance, but also to limit its weight. Another advantage of this solution is the structure of the surgical instrument 401, 501 is not modified, the surgical instrument 401, 501 is not machined, which limits the marking costs, as well as the risks. weakening the structure of the surgical instrument 401, 501.

Alternatively the protuberance may be on another portion of the surgical instrument and have a different shape, it will depend on the expectations of the user, the present invention is not limited to the applications proposed by this description, we can place a shape protuberance different on the lower part of the surgical instrument, or on another area of the instrument, but do not forget that this type of surgical instrument is invasive, it is then necessary that the part of the instrument of surgery surgery in contact with the patient keeps its original shape, the protuberance should not be on these parts. The advantages of the positioning, and the form proposed in these examples, are that the shape comes to marry the shape of the ring, without causing great disruption for the surgeon.

It will be noted that the transparency view present in these two figures makes it possible to see the positioning of the tag 404, 503 with respect to the surgical instrument 401, 501 inside the resin 402, 504. minimum 405 must be left between the chip and the structure of the surgical instrument. Indeed, the purpose of the present invention being inter alia to limit disturbances caused on the transfer of information between the tag and the transmitter / receiver, the positioning of the tag is then essential, a distance of at least 1 to 2mm must be left between the surgical instrument and the tag, this gap being filled with resin.

As an alternative to FIGS. 2A and 3B, which have two integration solutions of the present invention, two examples of surgical instruments having a base composed of two rings, it is possible to integrate on the second ring a second protrusion of resin, this second protuberance can be used to balance the surgical instrument so as not to change the work habits of the surgeon.

Alternatively this second protrusion could also contain a tag, to increase the detection field of the surgical instrument to mark. One could also imagine integrating several tags into each of the protuberances, tags oriented in different directions.

Alternatively it would be possible to multiply the resin protuberances on an instrument, each of these protuberances may contain one or more tags, this would increase the chances of identification of the marked surgery instrument. We can position these tags in different directions, to increase the chances of identifying the surgical instrument.

As a variant, the resin of the protuberances could be colored, according to a predefined color code, which would facilitate the visual traceability of the instruments, when there are no reading systems. Indeed a color code adapted to block number, or surgeon, could be adopted depending on the health facility in which the traceability system is installed.

Alternatively one could add to the resin of the protrusion an opaque radio element and easy to locate by radio waves, allowing a simple localization, this would easily check in case of loss of an instrument in the operating room that it does not did not stay in the patient's body.

In a variant, an objective is achieved when, for each of the processes mentioned above, it is advantageous to apply an insulator at the interface between the resin protuberance and the marking zone 602, 612 of the metal of the instrument to be marked. A step of integrating said insulation can then be added in the processes described above, before the step of integrating the resin protrusion to the instrument.

FIG. 6A shows a sectional view of the instruments 601 shown in FIGS. 2 and 3, this figure makes it possible to understand a method of integrating the protuberance 603. It should be noted in this figure that the resin protuberance 603 conforms well to the shape of the ring 602 of the instrument. This figure illustrates the following method of integrations of the protuberance 603, according to particular embodiments said tag 604 can be integrated directly with said resin to the instrument to be marked 601. It will be possible to add, during this step, advantageously an insulator at the level of the resin-metal interface 602. This integration with the surgical instrument may be done by molding in the case of a liquid or solid resin, under vacuum or otherwise a mold conforming to the shape of the ring 602 may be used. The said mold must precisely respect the position of the tag 604, indeed as explained above, the position of the tag relative to the instrument is very important to limit the disturbances of the metal surgery instrument on the electromagnetic field allowing the transfers of between the tag and the identification system, a minimum distance 606 of at least 1 mm must be respected between the instrument 602 and the tag 604. Moreover, a sufficient quantity of resin must surround 605, 607 said tag advantageously, a resin height of at least 1 mm will be respected, this thickness of resin will make it possible not to weaken the structure, and multiple readings in the case where the marked surgical instrument is surrounded by metal instruments.

As a variant, the method of integrating the protruding couple resin 603, tag 604 with the instrument, can be done either by gluing in the case of a pasty resin, the process by bonding involves a preliminary preparation of the resin used: the said resin is pre-cut and formed to accommodate the said tag 604, the cutout will accommodate the marking portion of said element to be marked 601. Tag 604 will be directly embedded in the space left vacant. The formed resin protuberance couple 603, tag 604, will be integrated into the surgical instrument 601 by gluing. During this step, advantageously an insulator may be added at the level of the resin-metal interface 602.

FIG. 6B shows a sectional view of the instruments 61 1 shown in FIGS. 2 and 3, this figure makes it possible to understand a method of integrations of the protuberance 613. It is noted in this figure that the protuberance 613 of resin conforms well to the shape of the ring 612 of the instrument. This figure illustrates the following methods of integrations of the protuberance 613, according to particular embodiments said protuberance 613 is first integrated with the element to be marked. During this step, it is advantageous to add an insulator at the level of the resin-metal interface 612. This protuberance 613 has a hollow zone 615, 614 of the form of said tag with additional space for closing 614. integration of the protuberance 613 to the surgical instrument 61 1 can be done either by molding, vacuum or not, using a mold conforming to the shape of the ring as described above. Said hollow will have to respect precisely the position of the tag 615, indeed as explained above, the position of the tag relative to the instrument is very important to limit the disturbances of the instrument on the electromagnetic field allowing the transfer of information between the tag and the identification system, a minimum distance 616 of at least 1 mm must be respected between the instrument 612 and the tag 615. Moreover a sufficient quantity of resin will have to surround 617, 618 said tag, advantageously one will respect a resin height of at least 1 mm, this thickness of resin will not weaken the structure, and a multiple reading in the case where the marked surgical instrument is surrounded by metal instruments. The diameter of said hollow will be substantially greater than the diameter of said tag 615. The depth of said hollow will be substantially greater than the sum of the depth of said tag 615, and the resin height required 618 to cover said tag 615 in its cavity, to provide protection, and maximum resistance of the resin couple 613, tag 615.

As a variant, the method of integrating the resin protuberance having a recess as previously described 614, 615 can be done either by gluing in the case of a pasty resin, the gluing process involves a preparation for preliminary of the resin used: said resin is pre-cut to the desired shape 613, leaving the housing defined for said tag 615 according to the characteristics mentioned in the preceding paragraph, or by any other method of bonding resin to metal, according to a particular process, under vacuum or not. During this step, advantageously, an insulator may be added at the resin-metal interface 612. The pair formed protrusion of resin 613, tag 615, will be integrated into the surgical instrument 601 by gluing.

The said tag 615 will then be positioned or wedged in the housing 615 left vacant in the said protuberance 613. The method of integrating the tag 615 on the instrument then comprises a step of positioning the cover 614, this cover will advantageously be same composition as the said protuberance 613. The said cover will be placed on the said tag to close the opening. Then a step comprising a welding operation of the cover to the rest of the protrusion 613, will be performed so that the outer surface of the protuberance has no protruding asperity. The said weld can be advantageously ultrasonically using a sonotrode, according to a particular method.

Alternatively, said cover 614 is bonded to the body of the protuberance 613 so as to seal the housing. The welding or gluing of the lid, under vacuum or not, ensures a continuity between the surface of the protrusion 613 and the cover 614, to ensure the tightness of the housing of said tag 615.

As a variant, another method of integrating the protruding couple 613, tag 615, could be illustrated by FIG. 6B. According to particular embodiments, said protuberance 613 is first integrated into the element to be marked, this protuberance 613 not having a hollow zone. This integration of the protuberance 613 to the element can be done either by molding, under vacuum or not, using a mold conforming to the shape of the ring as described above.

As a variant, the method of integrating the resin protuberance 613 can be done either by gluing in the case of a pasty resin, the gluing process involves a preliminary preparation of the resin used: the said resin is precut according to the desired form 613, or by any other method of bonding resin to metal, according to a particular method, under vacuum or not. During this step, advantageously, an insulator may be added at the level of the resin-metal interface 612. The method of integrating the tag on the instrument then comprises a step of machining the resin 613. A housing for the integration of said tag 615 and a cover 614 is then machined according to a particular method. The said housing must precisely respect the position of the tag 615, indeed as explained above, the position of the tag relative to the instrument is very important to limit the disturbances of the instrument on the electromagnetic field for the transfer of information between the tag and the system of identifications, a minimum distance 616 of at least 1 mm must be respected between the instrument 612 and the tag 615. Moreover a sufficient quantity of resin will have to surround 617, 618 said tag not to weaken the structure. The diameter of said housing will be substantially greater than the diameter of said tag 615. The depth of said housing will be substantially greater than the sum of the depth of said tag 615, and the resin height required 618 to cover said tag 615 in its cavity, to provide protection, and maximum resistance of the resin couple, tag. The said tag 615 will then be positioned or wedged in the housing 615 being left vacant in the said protuberance. The method of integrating the tag on the instrument then comprises a step of positioning the cover 614, this cover will advantageously have the same composition as the said protrusion 613. The said cover will be placed on the said tag to close the opening. Then a step comprising a welding operation of the cover to the rest of the protrusion 613, will be performed so that the outer surface of the protuberance has no protruding asperity. The said weld can be advantageously ultrasonically using a sonotrode, according to a particular method. Alternatively, said cover 614 is bonded to the body of the protuberance 613 so as to seal the housing. The welding or gluing of the cover makes it possible to ensure continuity between the surface of the protuberance and the cover, in order to ensure the tightness of the housing of said tag 615.

FIG. 7 shows an implant substitute 701 or of a polymer or plastic prosthesis, which is here a tibial prosthesis, on which has been incorporated a protuberance 702 of resin comprising a tag 703. This figure makes it possible to illustrate the method of integrating the present invention with any non-metallic instrument. The method of integrating the tag 703 on the instrument comprises a step of integrating the tag 703 with its resin envelope 702. In this case again this step can be done by molding, mold adopting the shape of the instrument to be marked , we will take care to respect the resin heights to be applied around the said tag 703 in order to ensure good resistance of the protruding couple, and multiple reading in the event that the marked instrument 701 is surrounded by metal instruments.

The method of integrating the tag 703 on the instrument 701 then comprises a step of welding the resin couple 702, tag 703, thus molded, this welding step can be done by an ultrasonic weld between the polymer or plastic of the marking element 701 and the resin of the protrusion 702. Alternatively this step may be a bonding step, or any other method of bonding resin to polymer, according to a particular method. As a variant, the method of integration of the present invention on medical instruments of the implant substitute type 701 or of a polymer or plastic prosthesis may also be carried out in the following manner, first under vacuum or not, a step of integrating a protuberance 702 of resin to the implant substitute 701, the protuberance 702 is either previously formed using a mold in the case of liquid or solid resin, mold respecting the size constraints, and of shape, and of no disturbance gripping the instrument, is formed by a cut in the case of use of a resin in the form of paste. Then making a machining of said protuberance 702, to create a housing for the tag 703, and a space for positioning a lid to close the said housing, the cover being advantageously of the same composition as the said protuberance 613, this machining will respect the positioning of the tag 703 in the resin 702, it will take care to respect the resin heights to be applied around the said tag 703 to ensure a good resistance of the protruding couple, and a multiple reading in the case where the marked instrument will be surrounded by metal instruments.

We will then be careful to position the said tag 703, in said housing, the positioning of the said tag to respect the shape of the space assigned to it. The said lid will be placed on the said tag in order to close the opening. Then a step comprising a welding operation of the cover to the rest of the protuberance 702, will be performed so that the outer surface of the protrusion 702 has no protruding asperity. The said weld can be advantageously ultrasonically using a sonotrode, according to a particular method. In a variant, the tag may be of a different shape than that presented here, it will then suffice to adapt the shape of the protuberance to the tag, and thus, adapt each step of the integration of the resin-tag pair, to the new data.

It should be obvious to those skilled in the art that the present invention allows embodiments in many other specific forms without departing from the scope of the invention as claimed. Therefore, the present embodiments should be considered by way of illustration, but may be modified in the field defined by the scope of the appended claims and the invention should not be limited to the details given above.

Claims

Medical device, comprising a surgical instrument (103, 201, 211, 301, 311, 401, 501, 701) reusable or not of metal (103, 201, 211, 301, 311, 401, 501), or of polymer or plastic, or any implant substitute (701) or prosthesis made of metal, polymer or plastic, provided with a marking system for rapid identification of the instrument, characterized in that the marking system comprises:

an RFID component (202, 212, 302, 312, 404, 503, 604, 615, 703) commonly called "tag", and

a protuberance (104, 203, 213, 303, 313, 402, 504, 603, 613, 702) made of resin integral with the surgical instrument (103, 201, 211, 301, 311, 401, 501) or implant substitute (701) to be marked, said protuberance completely enclosing and surrounding said tag (202, 212, 302, 312, 404, 503, 604, 615, 703).

Medical device according to claim 1, characterized in that the resin of the protuberance (104, 203, 213, 303, 313, 402, 504, 603, 613, 702) is an EPOXY type resin.

Medical device according to one of claims 1 or 2, characterized in that the protuberance (104, 203, 213, 303, 313, 402, 504, 603, 613, 702) incorporating the tag (202, 212; 302, 312 , 404, 503, 604, 615, 713) is attached to the surgical instrument (103, 201, 211, 301, 311, 401, 501) or to the implant substitute (701) to be marked at a location ( 403, 502, 602, 612) corresponding to a portion forming a gripping means of the instrument.

4. Medical device according to one of claims 1 to 3, characterized in that the resin thickness surrounding the tag (604, 615) is greater than or equal to 1 mm.

5. Medical device according to one of the preceding claims characterized in that the portion of the protuberance attached to the surgical instrument (103, 201, 21 1, 301, 31 1, 401, 501) or implant substitute (701) to marry the shape of said instrument (103, 201, 21 1, 301, 31 1, 401, 501) or said implant substitute (701).

6. Medical device according to one of the preceding claims characterized in that it comprises at least one additional protrusion (214, 314).

7. Medical device according to claim 6, characterized in that the additional protrusion (214, 314) is adapted to balance the surgical instrument (103, 201, 21 1, 301, 31 1, 401, 501) or the substitute implant (701).

8. Medical device according to one of claims 6 or 7 characterized in that said additional protrusion (214, 314) contains a tag.

Medical device according to one of the preceding claims, characterized in that at least one protuberance (104, 203, 213, 214, 303, 313, 314, 402, 504, 603, 613, 702) contains at least two tags. said at least two tags being oriented in different directions.

10. Medical device according to one of the preceding claims characterized in that at least one protrusion (104, 203, 213, 214, 303, 313, 314, 402, 504, 603, 613, 702) contains an opaque radio element .

1 1. Medical device according to one of the preceding claims, characterized in that a radiofrequency insulation is disposed between the instrument (103, 201, 21 1, 301, 31 1, 401, 501) or the implant substitute (701) to mark and the protuberance (104, 203, 213, 214, 303, 313, 314, 402, 504, 603, 613, 702).

Medical device according to one of the preceding claims, characterized in that at least one protuberance (104, 203, 213, 214, 303, 313, 314, 402, 504, 603, 613, 702) is color-coded to identify said medical device.