EP2701627A1 - Dispositif médical muni d'un système innovant de marquage, permettant une identification rapide, multiple et à distance - Google Patents
Dispositif médical muni d'un système innovant de marquage, permettant une identification rapide, multiple et à distanceInfo
- Publication number
- EP2701627A1 EP2701627A1 EP12722466.5A EP12722466A EP2701627A1 EP 2701627 A1 EP2701627 A1 EP 2701627A1 EP 12722466 A EP12722466 A EP 12722466A EP 2701627 A1 EP2701627 A1 EP 2701627A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- tag
- instrument
- protuberance
- resin
- medical device
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/90—Identification means for patients or instruments, e.g. tags
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/90—Identification means for patients or instruments, e.g. tags
- A61B90/92—Identification means for patients or instruments, e.g. tags coded with colour
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/90—Identification means for patients or instruments, e.g. tags
- A61B90/98—Identification means for patients or instruments, e.g. tags using electromagnetic means, e.g. transponders
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
- G06K19/00—Record carriers for use with machines and with at least a part designed to carry digital markings
- G06K19/06—Record carriers for use with machines and with at least a part designed to carry digital markings characterised by the kind of the digital marking, e.g. shape, nature, code
- G06K19/067—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components
- G06K19/07—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components with integrated circuit chips
- G06K19/077—Constructional details, e.g. mounting of circuits in the carrier
- G06K19/0772—Physical layout of the record carrier
- G06K19/07728—Physical layout of the record carrier the record carrier comprising means for protection against impact or bending, e.g. protective shells or stress-absorbing layers around the integrated circuit
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06K—GRAPHICAL DATA READING; PRESENTATION OF DATA; RECORD CARRIERS; HANDLING RECORD CARRIERS
- G06K19/00—Record carriers for use with machines and with at least a part designed to carry digital markings
- G06K19/06—Record carriers for use with machines and with at least a part designed to carry digital markings characterised by the kind of the digital marking, e.g. shape, nature, code
- G06K19/067—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components
- G06K19/07—Record carriers with conductive marks, printed circuits or semiconductor circuit elements, e.g. credit or identity cards also with resonating or responding marks without active components with integrated circuit chips
- G06K19/077—Constructional details, e.g. mounting of circuits in the carrier
- G06K19/07749—Constructional details, e.g. mounting of circuits in the carrier the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card
- G06K19/07758—Constructional details, e.g. mounting of circuits in the carrier the record carrier being capable of non-contact communication, e.g. constructional details of the antenna of a non-contact smart card arrangements for adhering the record carrier to further objects or living beings, functioning as an identification tag
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/28—Surgical forceps
- A61B17/29—Forceps for use in minimally invasive surgery
- A61B17/2909—Handles
- A61B2017/2911—Handles rings
Definitions
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- machining each instrument and incorporating small tags represents a considerable work time and is extremely expensive.
- 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.
- 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.
- 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.
- 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.
- 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.
- tag any type of RFID component such as said transponder, or RFID tag, or RFID chip, or electronic chip, or radio tag.
- tag any type of RFID component such as said transponder, or RFID tag, or RFID chip, or electronic chip, or radio tag.
- the invention is characterized in that said material is a resin.
- resins may correspond to the objectives of the present invention: epoxy type resins, polyamides, polycarbonates, polystyrenes, polyethylenes, polypropylenes, acrylonitriles, butadienes, styrenes, acrylics, polyurethanes, nylons.
- 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.
- EPOXY resin two-component, high thermal stability and resistant to the effects of water for plastic-metal compatible substrates, meeting medical standards.
- 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.
- the resin 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- the tag used for the present invention may be encapsulated in a structure before being integrated directly into said material.
- 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.
- 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.
- 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.
- 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.
- 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.
- a surgical instrument such as an iliac clamp
- 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.
- a surgical instrument such as a clamp called "PAD Cushing”
- 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.
- the medical device 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:
- 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.
- the resin of the protuberance is an EPOXY type resin.
- 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.
- 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.
- this additional protuberance may contain a tag.
- At least one protuberance is a protuberance
- radiofrequency insulation is disposed between the instrument or the implant substitute to be marked and the protuberance.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- FIG 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.
- 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.
- 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.
- 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.
- 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.
- 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 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 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- this second protrusion could also contain a tag, to increase the detection field of the surgical instrument to mark.
- tags could also be integrating several tags into each of the protuberances, tags oriented in different directions.
- each of these protuberances may contain one or more tags, this would increase the chances of identification of the marked surgery instrument.
- 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.
- a color code adapted to block number, or surgeon could be adopted depending on the health facility in which the traceability system is installed.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- FIG. 6B another method of integrating the protruding couple 613, tag 615, could be illustrated by FIG. 6B.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Public Health (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Pathology (AREA)
- General Health & Medical Sciences (AREA)
- Physics & Mathematics (AREA)
- Computer Hardware Design (AREA)
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Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR1101311A FR2974496B1 (fr) | 2011-04-26 | 2011-04-26 | Dispositif medical muni d'un systeme innovant de marquage, permettant une identification rapide, multiple et a distance |
PCT/FR2012/050898 WO2012146867A1 (fr) | 2011-04-26 | 2012-04-24 | Dispositif médical muni d'un système innovant de marquage, permettant une identification rapide, multiple et à distance |
Publications (1)
Publication Number | Publication Date |
---|---|
EP2701627A1 true EP2701627A1 (fr) | 2014-03-05 |
Family
ID=46146961
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP12722466.5A Withdrawn EP2701627A1 (fr) | 2011-04-26 | 2012-04-24 | Dispositif médical muni d'un système innovant de marquage, permettant une identification rapide, multiple et à distance |
Country Status (4)
Country | Link |
---|---|
US (1) | US20140088570A1 (fr) |
EP (1) | EP2701627A1 (fr) |
FR (1) | FR2974496B1 (fr) |
WO (1) | WO2012146867A1 (fr) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8600478B2 (en) | 2007-02-19 | 2013-12-03 | Medtronic Navigation, Inc. | Automatic identification of instruments used with a surgical navigation system |
US8477076B1 (en) * | 2012-01-25 | 2013-07-02 | Clearcount Medical Solutions, Inc. | Antenna coupler mechanism |
WO2014017530A1 (fr) * | 2012-07-24 | 2014-01-30 | 株式会社日本インフォメーションシステム | Appareil médical sur lequel est fixée une étiquette à circuit intégré et procédé de fixation de celle-ci |
WO2015086775A1 (fr) * | 2013-12-11 | 2015-06-18 | Caretag Surgical Aps | Fixation et protection d'une étiquette d'identification électronique |
US9280738B2 (en) | 2014-05-04 | 2016-03-08 | Haldor Advanced Technologies Ltd | Identification tag and attachment |
WO2015177490A1 (fr) * | 2014-05-23 | 2015-11-26 | Spa Track Medical Limited | Ensemble étiquette rfid |
US10187742B2 (en) | 2015-01-19 | 2019-01-22 | Haldor Advanced Technologies Ltd | System and method for tracking and monitoring surgical tools |
JP5924608B1 (ja) * | 2015-11-25 | 2016-05-25 | 有限会社東奥電気 | 器材管理システム、器材管理方法、およびコード付き器材 |
EP3471651B1 (fr) * | 2016-06-21 | 2020-03-11 | Haldor Advanced Technologies Ltd | Attache d'étiquette d'identification |
US20190167386A1 (en) * | 2017-07-19 | 2019-06-06 | Sreevatsan Raghavan | Smart orthodontic bracket |
FR3092985A1 (fr) * | 2019-02-22 | 2020-08-28 | Bruno Thoret | Procédé de marquage de prothèses au moyen d’une puce électronique RFID inerte et le dispositif de marquage isolé. |
DE102022124571A1 (de) * | 2022-09-23 | 2024-03-28 | Aesculap Ag | Elektrochirurgisches Instrument mit Transponder, Transponderkommunikationssystem und Herstellungsverfahren |
Family Cites Families (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5575810A (en) | 1993-10-15 | 1996-11-19 | Ep Technologies, Inc. | Composite structures and methods for ablating tissue to form complex lesion patterns in the treatment of cardiac conditions and the like |
EP0681252A1 (fr) | 1994-05-06 | 1995-11-08 | Takaharu Honda | Méthode pour marquer par un code un instrument chirurgical et instrument chirurgical muni d'un code |
FR2760630B1 (fr) | 1997-03-12 | 1999-09-24 | Chapelle Philippe | Procede de marquage d'instruments en vue de leur reconnaissance, et instrument obtenu par un tel procede |
US6366206B1 (en) * | 1999-06-02 | 2002-04-02 | Ball Semiconductor, Inc. | Method and apparatus for attaching tags to medical and non-medical devices |
EP1402470B1 (fr) * | 2001-05-21 | 2014-06-04 | Scott Laboratories, Inc. | Etiquette d'identification rf pour receptacle medical |
US7104502B2 (en) | 2004-03-31 | 2006-09-12 | Rosemount Aerospace Inc. | Ice detector for improved ice detection at near freezing condition |
FR2868939B3 (fr) * | 2004-04-14 | 2006-07-28 | Is Medical | Dispositif de tracabilite adaptable sur tous instruments et materiels de blocs operatoires |
US7307530B2 (en) * | 2005-02-10 | 2007-12-11 | Fabian Carl E | Surgical implement detector utilizing a radio-frequency identification marker |
US7256699B2 (en) * | 2005-03-24 | 2007-08-14 | Sdgi Holdings, Inc. | Button-type RFID tag |
US7837694B2 (en) * | 2005-04-28 | 2010-11-23 | Warsaw Orthopedic, Inc. | Method and apparatus for surgical instrument identification |
EP2062234A1 (fr) * | 2007-03-12 | 2009-05-27 | Rf Surgical Systems, Inc. | Logement et dispositif de transpondeur pour marquer des instruments |
FR2918769B1 (fr) * | 2007-07-09 | 2009-11-13 | Nicolas Bara | Marqueur d'identification radiofrequence radio opaque. |
FR2930887A1 (fr) | 2008-05-06 | 2009-11-13 | Ats Sferic Stellite S A S Soc | Instrument chirurgical invasif muni d'un transpondeur |
FR2935602A1 (fr) | 2008-09-09 | 2010-03-12 | Advanced Track & Trace | Dispositif medical reutilisable et procede pour le realiser |
FR2947713B1 (fr) | 2009-07-08 | 2011-09-09 | Sferic Stellite | Procede d'integration d'un composant rfid dans un substitut de prothese ou d'implant ou dans un instrument chirurgical en polymere ou en plastique |
-
2011
- 2011-04-26 FR FR1101311A patent/FR2974496B1/fr active Active
-
2012
- 2012-04-24 EP EP12722466.5A patent/EP2701627A1/fr not_active Withdrawn
- 2012-04-24 US US14/113,848 patent/US20140088570A1/en not_active Abandoned
- 2012-04-24 WO PCT/FR2012/050898 patent/WO2012146867A1/fr active Application Filing
Non-Patent Citations (2)
Title |
---|
None * |
See also references of WO2012146867A1 * |
Also Published As
Publication number | Publication date |
---|---|
FR2974496A1 (fr) | 2012-11-02 |
FR2974496B1 (fr) | 2014-10-17 |
US20140088570A1 (en) | 2014-03-27 |
WO2012146867A1 (fr) | 2012-11-01 |
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