DE102016121478A1 - Surgical instrument with RFID tag - Google Patents

Abstract

The invention relates to a surgical / medical instrument (4) having a basic instrument body (2), in particular of metal or plastic, and an identification element (20) arranged on the instrument main body (2), in particular an RFID transponder, for storing information and Identification, localization and / or identification of the surgical / medical instrument (4). The identification element (20) is accommodated in a recess (6) provided on the instrument main body (2), in particular in a shielded and insulated manner relative to the instrument main body (2). Moreover, the invention relates to a method for, in particular subsequent, introducing an identification element (20), in particular an RFID transponder, in a surgical / medical instrument (4).

Description

The invention relates to a medical / surgical / medical instrument having a basic instrument body, in particular made of metal or plastic, and an identification element arranged on the instrument body, in particular an RFID transponder, for storing information and for identifying, locating and / or identifying the medical / medical device. surgical / medical instrument.

State of the art

From the prior art it is known to equip medical devices and instruments with RFID transponders / tags / chips / pins on which electronic information and parameters for marking the device or instrument can be stored and on which the device / instrument can be automatically localized and identified by radio frequency identification or RFID (Radio Frequency Identification Device).

In other words, the Radio Frequency Identification not only enables localization of the appropriate equipment and instruments, but also provides efficient access to medical data (information on sterilization procedures, sterilization time, manufacturer, part number, serial number, date of manufacture, use and location, etc .) and therefore contributes to the improvement of the hospital's internal processes and to an increased patient safety. In particular, the documentation of work processes can be greatly simplified with the help of RFID technology.

RFID systems basically consist of an electronic data carrier, ie an RFID transponder / tag / chip / pin, and a reader. If the RFID transponder is within range of the reading device, communication and data exchange between the RFID transponder and the reading device can take place with the aid of electromagnetic waves, preferably inductively. An antenna of the reader basically emits radio waves, which are absorbed by the RFID transponder, converted and reflected back.

Up to now, RFID transponders / pins or identification elements in the prior art have always been attached or attached to an instrument outside, ie externally, to a surgical / medical / medical instrument or device by means of different joining methods. Attachment of the RFID tag exterior to the instrument, however, has proven disadvantageous in many respects.

On the one hand, medical / surgical / medical devices and instruments generally, in particular with regard to design requirements and the risk of damage to sterile packaging, have few edges, corners and thus flat surfaces, which makes it difficult to attach RFID identification elements on the outside of the instrument. In other words, the geometric shape and the design of the devices or instruments often hinder attachment of the RFID identification element on the outside of the instrument / device. In addition, it has been shown that due to the exposed arrangement of the marking elements on the outside of the instrument they are often dropped / destroyed or fail due to external mechanical stresses and strains and loads in the course of chemical treatments.

Brief description of the invention

Against this background, it is an object of the present invention to avoid or at least mitigate these disadvantages of the prior art. In particular, a secure attachment of an RFID tag to a medical / surgical / medical instrument or device is to be provided and an improved protection of the RFID tag to mechanical, thermal, chemical or other external loads can be realized without the functionality or functionality of the RFID -System influence or affect.

This object is achieved by a surgical / medical instrument having the features of claim 1 and a method for, in particular subsequent, introduction of an identification element in a surgical / medical instrument having the features of claim 10. Advantageous embodiments / examples or developments are claimed in the subclaims and / or explained below. A surgical / medical instrument is understood below and in the claims to be any type of medical, surgical or medical instrument or device. In other words, the subject matter of the claims is not limited to surgically used medical instruments such as surgical scalpels, knives, scissors, tweezers, forceps, clamps, hooks, spreaders, retainers, etc. but relates to any type of medical work equipment (especially mobile but also stationary, both reusable and one-way).

The invention relates first to a surgical / medical / medical instrument with a basic instrument body, in particular made of metal or plastic, and arranged on the instrument body (electronically readable) identification element (information carrier), in particular an RFID tag / RFID transponder / RFID (transponder ) Pin, for storage of information and for identification, localization and / or identification of the surgical / medical / medical instrument. The marking element is accommodated in a recess provided on the instrument main body, in particular in a shielded and insulated manner relative to the instrument main body.

The identification element according to the invention is preferably an electronic data carrier, such as an RFID transponder / tag / chip / pin or the like, and is securely and captively received, fixed, secured and aligned in a recess / recess provided on the instrument main body. In other words, the identification element is recessed in the surgical instrument / instrument main body, that is, at least partially disposed within the instrument main body. Thus, according to the invention, a repeatable, in particular subsequent, insertion of an identification element into a surgical instrument is made possible, and at the same time an improved protection against mechanical and chemical stress, in particular during chemical preparation and handling of the surgical instrument, is provided.

Preferably, the identification element is completely arranged without external projection in the recess and thus within the instrument base body / received (that is, flush with the surface).

The identification element thus preferably has no outwardly projecting / protruding sections and is therefore suitably protected against external mechanical loads. The marking element according to the invention can not simply be dropped or destroyed by the improved protection achieved. The identification element is preferably adapted in shape and size to the recess / to a portion of the recess (or vice versa) (label element aligned) and received positively and / or cohesively in the recess.

It is advantageous if the marking element for shielding against the preferably metallic instrument main body of an insulating element, in particular of glass and / or a plastic / resin / glass fiber reinforced plastic (GRP) / non-ferrous metal (non-ferrous metal), sheathed / enclosed / surrounded / encapsulated.

Preferably, the insulation element / the insulation device is designed as a non-metallic, in particular non-ferrous metallic insulation capsule / insulation sleeve / insulation encapsulation. In particular, it has been found that a suitable shielding or insulation of the identification element / RFID transponder to the metallic instrument main body can be achieved by an insulation element / an insulation device made of glass / plastic / resin / GRP / non-ferrous metal. The shielding ensures that an antenna signal of the identification element / RFID transponder is not disturbed by the metallic base material of the instrument main body. Interference signals can thus be excluded by preference, but at least inhibited. In addition, a read-out of the identification element / RFID transponder with the aid of a reading device is made possible only by the shielding of the identification element / RFID transponder to the metallic instrument main body. Preferably, the identification element formed as an RFID transponder / pin is completely encapsulated by a sleeve / capsule / encapsulation / enclosed / enclosed / surrounded and / or the sleeve / capsule / encapsulation together with the marking element completely without outer projection (flush with the surface) within the received on the instrument base body provided recess and fixed therein / secured. The insulation element can preferably be adapted in shape and size to any recess provided on an instrument main body.

Advantageously, the marking element is firmly bonded by means of a plastic element and / or adhesive and / or casting resin and / or filler layer surrounding the marking element and protecting it against external influences, and / or the recess is defined by the plastic and / or or adhesive and / or casting resin and / or filler completely filled / filled.

Preferably, therefore, the insulating element, which encapsulates the (RFID) identification element, completely surrounded by a plastic / adhesive / casting resin / filler. The marking element is thus preferably fixed by means of the plastic / adhesive / casting resin / filler within the recess and a cavity which remains when the identification element is arranged together with the insulating element in the recess or sunk, is completely with the Plastic / adhesive / cast resin / filler filled. From an instrument outside then preferably only the plastic / adhesive / casting resin / filler is visible and visible from the outside plastic / adhesive / cast resin / filler layer is flush with the instrument main body, in particular a Instrumentengrundkörperumwandung (body surface) from. It is thus achieved that a, preferably encapsulated in an insulating element designed as an RFID transponder / pin identification element is securely and captively fixed within a basic instrument body of a surgical instrument / aligned / attached. The marker is then, in some respects, sealed off to the outside / to an outside of the instrument and protected within the recess. The plastic / adhesive / cast resin / filler layer also provides suitable protection against external chemical and mechanical stresses. At the same time, the plastic / adhesive / cast resin / filler layer allows leakage of electromagnetic signals / radio frequency waves from the (RFID) tag to an instrument exterior. Preferably in the plastic / adhesive / casting resin / filler color pigments for individual coloring, identification and recognition (corporate identity) are included.

An advantageous embodiment is characterized in that the recess has at least one blind hole / blind hole-like bore / is adapted in shape and size to the preferably pin-shaped or cylindrical identification element that the pin-shaped or cylindrical marking element repeatable and aligned in a predetermined, defined Direction can be used in the blind hole.

The insulation element and the identification element accommodated therein are thus preferably pin-shaped or cylindrical and are received within the blind-hole-like bore without an outer projection. A length of the identification element embodied as an RFID transponder pin is preferably larger than a diameter of the blind bore and a blind base of the blind hole preferably constitutes a stop for the identification element, so that a repeatable, reproducible and aligned insertion thereof into the recess can be achieved. In other words, a geometry of the insertion / recess is designed in such a way that the identification element can be introduced in a predetermined position and orientation into the instrument main body of different surgical instruments in a repeatable and reliable manner.

It is expedient if the recess has at least one, preferably two, three or more signal bores, which extend from an instrument outside to the identification element and allow escape of, in particular electromagnetic, signals from the identification element located within the instrument main body to an instrument exterior. Provision of at least one signal bore makes it possible for the identification element / RFID transponder to be better recognized and read by a reader or a tunnel reader. The signal port is basically an aperture implemented in the instrument body which does not shield the electromagnetic signals or radio frequency waves of the tag / RFID transponder. Preferably, the recess according to the invention of a blind hole and at least one signal hole is formed and the at least one signal hole extends to the blind hole down. Egress of electromagnetic signals / radio frequency waves is then made possible both via the signal bore and via the blind hole bore to an instrument outside. More preferably, a plurality of preferably uniformly distributed signal bores are provided, which extend from different sides to the identification element and allow leakage of electromagnetic signals in different spatial directions, which in turn a suitable readability of the signals in different spatial directions is achieved.

Moreover, it is advantageous if the recess is a blind hole receiving the marking element and a signal bore formed in particular as an extension of the blind bore, reduced in diameter relative to the blind bore and / or at least one, preferably two, from an outside of the instrument to a lateral surface of the blind bore, preferably Has at least approximately perpendicular to the lateral surface of the blind hole standing and / or compared to the blind hole diameter-reduced, signal holes.

If the at least one signal bore is reduced in diameter relative to the blind bore and the identification element (with isolation element) is adapted in shape and size to the blind bore, the marker does not fit into the signal bore and a user can not inadvertently insert the marker into the signal bore. Particularly preferably, the recess according to the invention consists of a blind hole, one formed as an extension of the blind hole and thus parallel to the blind hole Signal bore and two from opposite sides of a Instrumentengrundkörperumwandung to a lateral surface of the blind hole reaching signal holes. All provided signal holes are reduced in diameter in an advantageous manner relative to the blind hole. The defined by the signal holes and the blind hole cavity is preferably completely filled with plastic / adhesive / casting resin / filler, so that the marking element against an instrument outside at all openings (signal holes, blind hole) is completely sealed.

It is advantageous if a plastic and / or an adhesive and / or a casting resin and / or a filler from the instrument outside on the blind hole and / or the at least one signal bore in the instrument body for fixing and securing the marking element within the instrument main body and is introduced for sealing the recess to an instrument outside.

Particularly preferably, the plastic / adhesive / casting resin / filler, in particular under pressure, at the same time introduced via the blind hole and the at least one, preferably two, three or more signal holes in the recess, that the marking element is accommodated with insulation element centered in the blind hole. The insulating element is preferably completely surrounded by the plastic / adhesive / filler / sheathed and thus not in contact with the preferably metallic instrument main body.

In addition, the identification element embodied as an RFID transponder pin is preferably received in a discharge direction of the same in a blind hole of the recess.

In other words, an antenna of the RFID transponder pin is arranged such that an axial direction of the blind hole bore coincides with the emission direction of the RFID transponder pin. This is achieved when the antenna is at least partially perpendicular to the axial direction of the blind hole arranged or aligned. Particularly preferably, the antenna is arranged and aligned such that it is at least partially or approximately perpendicular both on the blind hole and on the provided signal holes.

This is achieved, for example, when the blind bore and the signal holes provided lie in one plane and the antenna is at least partially or approximately perpendicular to this plane. If the RFID transponder pin is received in the same direction in the blind hole, optimal signal transmission from electromagnetic signals / radio frequency waves to the outside can be achieved.

The invention further relates to a method for, in particular subsequent, introduction of an identification element, in particular RFID transponder, in a surgical / medical instrument, in particular as described above, with the steps: inserting the located in an isolation element marking element in a on, in particular metallic, instrument main body of the surgical instrument previously elaborated recess; and injecting / introducing a plastic and / or filler and / or adhesive material into the recess for securing and fixing the inserted or to be inserted identification element within the instrument base body (or within components that are fixed / fixed to the instrument main body).

In summary, according to the invention, an isolated (RFID) identification element is provided which is secure, captive, invisible, repeatable, reproducible, process-reliable and resistant to chemical and mechanical stresses within a basic instrument body of a surgical / medical / medical instrument / device is. By provided on the instrument main body openings which do not shield the signals of the marking element, a readability of the marking element can be ensured by means of a reader / Tunnelreaders. The functionality or functionality of the RFID system according to the invention is in no way influenced or impaired. Existing instruments can also be retrofitted with the present invention in a simple manner.

list of figures

• 1 eine Schnittansicht einer Anordnung eines Kennzeichnungselements in einem ersten Instrumentengrundkörper;
• 2 eine Schnittansicht einer Anordnung eines Kennzeichnungselements in einem zweiten Instrumentengrundkörper;
• 3 eine Schnittansicht einer Anordnung eines Kennzeichnungselements in einem dritten Instrumentengrundkörper; und
• 4 eine Schnittansicht einer Anordnung eines Kennzeichnungselements in einem vierten Instrumentengrundkörper.

The invention will be further explained below with the aid of figures. Show it:

• 1 a sectional view of an arrangement of an identification element in a first instrument body;
• 2 a sectional view of an arrangement of an identification element in a second instrument body;
• 3 a sectional view of an arrangement of an identification element in a third instrument body; and
• 4 a sectional view of an arrangement of an identification element in a fourth instrument body.

figure description

The figures are merely schematic in nature and are for the sole purpose of understanding the invention. The same elements are provided with the same reference numerals.

In the 1 to 4 each are a sectional view of an instrument main body 2 a surgical / medical instrument according to the invention 4 shown. The surgical / medical instrument 4 For example, it may be a surgical scalpel, knife, scissors, tweezers, forceps, clamp, hook, spreader, holder, or the like. The surgical / medical instrument 4 however, it may be any other surgical, medical, or medical device or instrument.

In 1 has the metallic instrument body 2 of the present surgical / medical instrument 4 a recess 6 on, which is a blind hole 8th and three (at least one) signal holes 10 . 12 . 14 composed. The blind hole 8th and the signal bores 10, 12, 14 are in one plane, namely in the in 1 arranged cutting plane arranged. In other words, the axes of the signal holes lie 10 . 12 . 14 in the same plane as the axis of the blind hole 8th , The blind hole 8th ranges from an instrument outside 16 in the basic instrument body 2 into, does not penetrate this and stands in 1 slanted on an instrument surface / outside 17. The signal bore 10 is as a diameter-reduced, coaxial extension of the blind hole 8th educated. The signal holes 12 . 14 are regarding the blind hole 8th arranged diametrically opposite one another and are obliquely on a lateral surface 18 the blind hole 8th , The signal holes 12 . 14 are parallel to each other, but not coaxial but in the axial direction of the blind hole 8th staggered. The signal holes 12 . 14 show how the signal hole 10 a smaller diameter than the blind hole 8th on.

In 2 has the instrument main body 2 as well a recess 6 with a blind hole 8th and three (at least one) signal holes 10 . 12 . 14 on which all in one level, namely in the 2 Section shown, are arranged. That means also in 2 lie the axes of the signal holes 10 . 12 . 14 in the same plane as the axis of the blind hole 8th , The blind hole 8th ranges from an instrument outside 16 in the basic instrument body 2 in and the signal hole 10 is as a diameter-reduced, coaxial extension of the blind hole 8th educated. The signal holes 12 . 14 are in 2 regarding the blind hole 8th diametrically opposed, parallel and approximately coaxial with each other (slightly offset), have a smaller diameter than the blind hole 8th up and upright on the blind hole 8th or a lateral surface 18 the blind hole 8th ,

Also in 3 has the metallic instrument body 2 of the present surgical / medical instrument 4 a recess 6 on, which is a blind hole 8th and three (at least one) signal holes 10 . 12 . 14 composed. The axes of the signal bores 10 . 12 . 14 again lie in the same plane as the axis of the blind hole 8th , The blind hole 8th ranges from an instrument outside 16 in the basic instrument body 2 into, does not penetrate this and stands in 3 perpendicular to an instrument surface / exterior 17. The signal bore 10 is as a diameter-reduced, coaxial extension of the blind hole 8th educated. The signal holes 12 . 14 are regarding the blind hole 8th arranged diametrically opposite one another and are perpendicular to a lateral surface 18 the blind hole 8th , The signal holes 12 . 14 are arranged parallel to each other and coaxially. The signal holes 12 . 14 have a smaller diameter than the blind hole 8th on.

In 4 has the metallic instrument body 2 again a recess 6 on, which is a blind hole 8th and three (at least one) signal holes 10 . 12 . 14 composed. The axes of the signal bores 10 . 12 . 14 again lie in the same plane as the axis of the blind hole 8th , The blind hole 8th ranges from an instrument outside 16 in the basic instrument body 2 into, does not penetrate this and stands in 4 perpendicular to an instrument surface / exterior 17. The signal bore 10 is as a diameter-reduced, coaxial extension of the blind hole 8th educated. The signal holes 12 . 14 are regarding the blind hole 8th diametrically opposite each other, parallel to each other and in the axial direction of the blind hole 8th arranged offset (not coaxial) and are perpendicular to a lateral surface 18 the blind hole 8th , The signal holes 12 . 14 also point in 4 a smaller diameter than the blind hole 8th on.

The 1 to 4 show various embodiments of the invention or embodiments of the recess 6 within the instrument body 2 , In particular, it should be shown that the inventive concept can be applied to many different (cross-sectional shapes of) instrument main body (s) 2. By way of example, in the figures, rectangular cross-sectional shapes (see 1 and 3 ), a round cross-sectional shape (see 2 ) and a parallelogram-like cross-sectional shape (see 3 ). However, the present invention is based on arbitrarily shaped instrument body 2 applicable. All embodiments have in common is that all signal holes 10 . 12 . 14 in each case to the outside of the instrument main body 2 / to the outside of the instrument 16 are open.

The following description refers to all 1 to 4 ,

In the blind hole 8th the recess 6 is a designed as an RFID transponder pin identification element 20 added. The label element 20 is of a designed as a glass capsule / glass sleeve insulation element 22 enclosed. The label element 20 is in front of the instrument body 2 isolated and shielded way in the recess 6 added. The label element 20 and the isolation element 22 are completely without outer projection in the blind hole 8th recorded and thus within the basic instrument body 2 arranged.

The label element 20 and the isolation element 22 are inside the recess 6 by means of a plastic / adhesive / cast resin / filler layer 24 fixed. Both the blind hole 8th as well as the signal bores 10 . 12 . 14 are completely through the plastic / adhesive / cast resin / filler layer 24 completed or filled. The plastic / adhesive / casting resin or filler is preferably simultaneously from the instrument outside 16 over the blind hole 8th and the signal holes 10 . 12 . 14 injected under pressure, leaving the insulation element 22 and the label element 20 in the middle in the blind hole 8th are arranged and the insulation element 22 thus not directly on the instrument body 2 is applied. The plastic / adhesive / cast resin / filler layer 24 is thus preferred between the insulating element 22 and the instrument main body 2 provided, whereby a further improved insulation and shielding of the marking element 20 to the instrument main body 2 is reached.

Because of the blind hole 8th or the signal holes 10 . 12 . 14 protrude from different sides / from different directions in the instrument main body and each with the plastic / adhesive / Gießharz- / or filler layer 24 filled / filled, becomes an excellent fixation of the label element 20 within the instrument body 2 reached.

The blind hole 8th is in shape and size to the insulation element 22 or to the label element 20 customized. A diameter of the marking element 20 and the insulation element 22 is larger than a diameter of the signal holes 10 . 12 . 14 ,

An antenna, not shown, of the identification element designed as an RFID transponder pin 20 is preferably aligned such that a radiation direction thereof with an axial direction of the blind hole 8th coincides. In other words, the antenna is perpendicular to the axial direction of the blind bore 8th arranged or aligned. If the antenna of the marking element, not shown 20 on the in the 1 to 4 represent cross-sectional plane is vertical, electromagnetic signals or radio frequency waves on the blind hole 8th as well as the signal bores 10 . 12 . 14 to an instrument outside 16 reach. The electromagnetic signals or radio frequency waves of the marking element 20 be through the isolation element 22 and the plastic / adhesive / cast resin / filler layer 24 neither inhibited nor stopped and can thus on the blind hole 8th and the signal holes 10 . 12 . 14 get to an instrument outside, so that readability of the label element 20 is made possible by means of a reader or tunnel reader not shown in different directions.

LIST OF REFERENCE NUMBERS

2

Instrument base body

4

surgical / medical instrument

6

recess

8th

Blind hole

10

signal hole

12

signal hole

14

signal hole

16

Instrument outside

17

Instrument surface / outside

18

lateral surface

20

identification element

22

insulation element

24

Plastic / adhesive / casting resin / or filler layer

Claims (10)

Surgical / medical instrument (4) with a basic instrument body (2), in particular made of metal or plastic, and an identification element (20) arranged on the instrument main body (2), in particular an RFID transponder, for storing information and for identification, localization and / or identification of the surgical / medical instrument (4), characterized in that the identification element (20) is received in a recess (6) provided on the instrument main body (2), in particular in a shielded and isolated manner relative to the instrument main body (2) , Surgical / medical instrument (4) according to Claim 1 , characterized in that the identification element (20) is arranged completely without outer projection in the recess (6) and thus within the instrument base body (2). Surgical / medical instrument (4) according to Claim 1 or 2 , characterized in that the marking element (20) for shielding against the preferably metallic instrument main body (2) of an insulating element (22), in particular of glass and / or plastic and / or synthetic resin and / or glass fiber reinforced plastic and / or non-ferrous Metal, is enclosed. Surgical / medical instrument (4) according to one of the preceding claims, characterized in that the marking element (20) cohesively by means of a marking element (20) surrounding and this protects against external influences plastic and / or adhesive and / or Gießharz- and / or filler layer (24) is fixed within the recess (6) and / or the recess (6) through the plastic and / or adhesive and / or casting resin and / or filler layer (24) is completely filled. Surgical / medical instrument (4) according to one of the preceding claims, characterized in that the recess (6) has at least one blind hole (8) and / or which in shape and size in such a way to the preferably pin-shaped or cylindrical identification element (20). is adapted, that the marking element (20) is repeatedly accurate and aligned in a predetermined, defined direction in the blind hole (8) can be inserted. Surgical / medical instrument (4) according to one of the preceding claims, characterized in that the recess (6) has at least one, preferably two, three or more signal bores (10, 12, 14) which extend from an instrument outer side (16) towards reach the identification element (20) and allow the escape of signals from the identification element (20) located within the instrument main body (2) to an instrument exterior (16). Surgical / medical instrument (4) according to one of the preceding claims, characterized in that the recess (6) has a blind hole (8) receiving the marking element (20) and a blind hole (8) formed as an extension of the blind hole (8) ) diameter-reduced signal bore (10) and / or at least one, preferably two of an instrument outer side (16) to a lateral surface (18) of the blind hole (8) reaching, preferably at least approximately perpendicular to the lateral surface (18) standing and / or against the Blind hole (8) diameter-reduced, signal bores (12, 14). Surgical / medical instrument (4) according to Claim 7 , characterized in that a plastic and / or an adhesive and / or a casting resin and / or a filler from the instrument outer side (16) via the blind hole (8) and / or the at least one signal bore (10, 12, 14) in the Instrument main body (2) for fixing and securing the identification element (20) within the instrument base body (2) and for sealing the recess (6) to an instrument outer side (16) is introduced. Surgical / medical instrument (4) according to one of the preceding claims, characterized in that the identification element (20) designed as an RFID transponder pin is received in a discharge direction of the same in a blind hole (8) of the recess (6). Method for, in particular retrofitting, introducing an identification element (20), in particular RFID transponders, into a basic instrument body (2) of a surgical / medical instrument (4), in particular according to one of the preceding claims, comprising the steps of: inserting itself into an isolation element (22) located marking element (20) in a on a, in particular metallic, instrument main body (2) of the surgical instrument (4) previously elaborated recess (6); and introducing a plastic and / or filler and / or adhesive layer (24) into the recess (6) for Securing and fixing the inserted or to be used labeling element (20) within the instrument main body (2).

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