DE202014100483U1 - Foil cover for protecting a rod-shaped medical instrument and medical instrument system - Google Patents

Abstract

A film cover (2) for protecting a rod-shaped medical instrument (8), comprising a telescopically folded film cover (1) and an insertion opening (9) at the proximal end (10) of the film cover (1) and with leaf-shaped lining parts (13, 14 ) is formed of flexible material which are completely separated when closed and which are openable to open the insertion opening (9) by means of pressure on side edges (15, 16) spatially, characterized by a plug-in receptacle (3) at the distal end (4). the film casing (1) is formed and adapted to receive a medical working tool (5) which is to be detachably coupled to a medical instrument (8) to be inserted into the film casing (1) via the insertion opening (9), wherein in the plug receptacle (3 ) an inner and an outer plug sleeve (6, 7) aufeinanderitzen, such that the film envelope (1) is clamped therebetween.

Description

The invention relates to a film coating for protecting a rod-shaped medical instrument and a medical instrument system.

background

Such film coatings are aids for the protection of any medical instruments, in particular surgical instruments, against septic contamination during the use of the medical instrument, for example during an operation.

From the document EP 0 371 909 A1 is a film coating for the protection of a surgical instrument known which has a telescopic pleat. The insertion of the film coating is formed with two elastic leaf-shaped, with the insertion opening closed over the entire surface, each two opposite each other, substantially congruent side edges and spatially spread apart lining parts. The insertion opening is formed at the proximal end of the telescopically folded film envelope. At the opposite distal end of the film sleeve is bagged.

Summary

The object of the invention is to provide an improved film coating for the protection of a rod-shaped medical instrument and a medical instrument system in which a film coating is formed in a simple and inexpensive manner producible, which application can be coupled to a medical work tool.

To achieve the object, a film coating for protecting a rod-shaped medical instrument according to claim 1 is provided. Furthermore, a medical instrument system according to the independent claim 11 is provided. Advantageous embodiments are the subject of dependent subclaims.

According to one aspect, a film cover for protecting a rod-shaped medical instrument is provided, which has a telescoping film envelope, in particular plastic film, with an insertion, which is formed at the proximal end of the film envelope and with leaf-shaped lining parts of flexible material, the entire surface in the closed state and which are openable to open the insertion by means of pressure on side edges jaw-like. The rod-shaped medical instrument can then be inserted into the film casing through the insertion opening thus opened. At its distal end, the foil wrapper has a plug-in receptacle which is set up to receive a medical working tool, which is then releasably coupled to the medical instrument inserted into the foil wrapper via the insertion opening. In this way, any combination of medical instrument and medical work tool can be used in conjunction with the film coating. The plug-in receptacle is formed with an inner and an outer plug-in sleeve, which are arranged aufeinander sitting so that the film envelope is clamped therebetween. With the help of this clamp connection, the plug-in receptacle is secured with the receptacles at the distal end of the film envelope.

In one embodiment, it may be provided to provide an article in which the film cover is arranged in a sterile packaging.

In another aspect, a medical instrument system is provided. The instrument system has a film coating of the aforementioned type, in which the telescoping film envelope is at least partially unfolded. In the at least partially unfolded film envelope a rod-shaped medical instrument is inserted through the insertion opening at the proximal end. A medical work tool is inserted into the socket at the distal end of the film wrap and releasably coupled within the film wrap to the rod-shaped medical instrument. The instrument system formed in this way is prepared for medical use, for example as part of an operation. After use, the medical instrument can be released from the working tool and removed from the foil cover. Foil cover and remaining in the socket medical working tool can then be disposed of as used disposable items professionally. For a new application, the medical instrument is then used with a new foil cover and a new working tool inserted here in the plug-in receptacle.

The plug-in receptacle on the film cover can be produced with the help of the receptacles in a simple manner and with little effort. At the same time secures the clamping connection with the clamped between the sockets film sleeve secure attachment of the plug-in receptacle on the film envelope. Even in use, the film cover with the plug-in receptacle is easy to use by the medical work tool, such as a working electrode, is inserted from the front into the socket.

A further development provides that the film envelope is closed in the unused initial state in the region of the distal end. This means that the front access to the interior of the plug-in receptacle is closed by the foil cover. The medical working tool can only be inserted into the plug-in receptacle by puncturing the foil cover in this case. Alternatively, it can be provided that on the front of the plug-in receptacle, the foil cover forms an opening assigned to the interior of the plug-in receptacle into which the medical working tool can then be inserted in order finally to fix it in the plug receptacle. In the various embodiments, it may be provided that the film casing on the front side of the plug-in receptacle protrudes in a length or a circumference, which allows inserted when inserting the working tool from the front into the plug-in portions of the front side projecting film envelope into the interior of the plug receptacle be clamped in this way between the working tool and the inner surface of the inner receptacle.

In one embodiment, it may be provided that the film casing has a perforation in a section arranged on the front side of the plug-in receptacle. The plug-in receptacle associated perforation, in particular a predetermined breaking point can be formed, can reduce the resistance of the film sleeve during insertion of the medical work tool into the socket. With the aid of the perforation, in one embodiment, a predetermined tear line for a distal tip of the foil wrapper may be made at the distal end thereof so that the user can sever the distal tip of the foil wrapper prior to insertion of the medical implement by taking the tip between two fingers and peeling it off becomes.

The portion of the foil cover on the front side of the plug-in receptacle can span a front opening of the plug receptacle. The overvoltage of the front opening of the plug-in receptacle may be such that the film envelope is stretched in a planar shape on the opening.

The plug-in receptacle can be arranged in a tapered section of the film casing.

An embodiment may provide that the inner and / or outer plug sleeve are designed as a hollow cylinder. The inner and / or the outer sleeve may be formed as a tube sleeve with the same or different wall thickness. In a simple embodiment, the tube sleeves may be pieces of a flexible and elastic material tube.

The inner plug-in sleeve can have one or more projections and / or one or more depressions on a sleeve inner side. With the aid of projections and / or depressions, the fixation of the medical working tool in the plug-in supportive elements may be formed. The projections and / or recesses may be circumferentially formed on the inside, be it in continuous and / or interrupted form. The projections and / or recesses may in this case cooperate with associated complementarily executed depressions and / or projections on the medical working tool. The formation of one or more circumferential lips may be provided.

A further development may provide that the inner plug-in sleeve has on one outer side of the sleeve and / or the outer plug-in sleeve has one or more clamping projections and / or clamping recesses on a casing inner side. Clamping projections and clamping recesses on the two sleeves can interlock. But it can also press clamping projections on an opposite smooth surface to support the clamp connection.

The inner and / or the outer receptacle may consist of a yielding material. Alternatively or additionally, the inner and / or the outer plug sleeve may be formed from an elastic and / or a flexible material. For example, a silicone material can be used.

One embodiment provides that the inner and the outer plug-in sleeve and the film sleeve clamped therebetween are adhesively bonded in the region of the plug-in receptacle. This means in particular that the clamping connection between the sleeves and the film envelope is formed free of adhesives. Also, no adhesion is produced in adhesion-free training. The plug-in receptacle can be formed separable, such that the receptacles are separable from each other, whereby the clamped portion of the film envelope is released again. In an alternative embodiment, an adhesive bond is made between the sleeves and / or between sleeves and film wrap material. This can be done using adhesives, for example. Alternatively, the heating may be provided for forming a fusion bond or the ultrasonic welding.

The film cover can be used in conjunction with any medical instruments. For example, in the surgical fields of medicine, especially in surgery, it is necessary to cut tissue and blood vessels close to avoid blood loss. Among others, diathermy is available for this purpose. Here, by means of a generator (RF generator) high-frequency alternating currents are used, which are passed through the patient. For this purpose, two electrodes are applied to the organism: a planar electrode (so-called neutral electrode) and a pointed electrode (cautery). When closing the circuit, the passage of the alternating current in the organism and at the contact of the electrodes to the body or tissue generates heat, wherein the generated heat is concentrated under the point electrode due to the increased current density punctiform and leads to the heating of the adjacent tissue. As a result, the tissue is circumscribed denatured. Depending on the quality of the selected alternating current, the tissue can be carbonized or shrunk thereby resulting in separation of the tissue and / or occlusion of blood vessels contained therein.

In the medical instrument system with film coating and medical instrument can be provided that the medical work is a working electrode. In one embodiment, it may be a diathermy electrode, which then couples to a high frequency generator which is connected to the medical instrument received in the foil sheath, wherein the medical instrument may be a handpiece.

Description of exemplary embodiments

In the following, further embodiments will be explained in more detail with reference to figures of a drawing. Hereby show:

1 a schematic representation of a medical instrument system in which a film envelope of a film coating is telescopically folded,

2 a schematic representation of the medical instrument system 1 , wherein the film cover is partially unfolded, and

3 a schematic representation of a plug-in receptacle in cross section.

1 shows a schematic representation of a medical instrument system in which a foil cover 1 a film coating 2 is folded telescope. When displayed in 2 is the foil cover 1 partially unfolded.

The foil cover 1 may be designed as a plastic film, preferably as a polyethylene film with wall thicknesses of about 0.01 mm to about 1.00 mm.

According to 1 is in a plug-in receptacle 3 at the distal end 4 the foil cover 1 an executed here as an electrode, medical work tool 5 plugged in. The plug-in receptacle 3 is in accordance with the detailed representation in 3 with an inner socket 6 and an outer receptacle 7 educated. Between the sockets 6 . 7 is the foil cover 1 clamped.

As shown in 2 couples the work tool 5 to a medical instrument 8th , For example, handpiece, which is designed rod-shaped and through an insertion 9 at the proximal end 10 the foil cover 1 is introduced herein.

The work tool designed as an electrode 5 has an electrically conductive pin 11 (Tip electrode), preferably a metal pin which extends through a tool sleeve 12 extends from an electrically non-conductive material, in particular plastic. The electrically conductive pin 11 extends outside and inside the foil wrapper 1 , The outer part of the pen 11 can be designed as a tip, ball, sling, hook or blade or cutting edge. The inner part of the pen 11 is designed so that it can be connected to a commercially available handpiece of a diathermy device (cf. 2 ).

The diathermy procedure presupposes the following electrical or electronic components: a control unit with HF generator (not shown) connected to the general power supply (alternating current 230 V), a handpiece with pushbutton switches for receiving the tip electrode, a connecting cable of the handpiece to the control unit ( not shown), the tip electrode which is inserted into the handpiece, a neutral electrode with cable (not shown), which connects with the organism (human, animal) with the control unit. Instead of key switches on the handpiece also connected to the control unit foot switch can be used.

Another method dispenses with a planar neutral electrode and places the electrodes in a pointed shape in the manner of the branches of tweezers. The tip electrode faces the neutral electrode without interposition of the organism. This allows tissue taken between the two electrodes to be heated and denatured at the conclusion of the circuit. In this case one speaks of bipolar coagulation of the tissue. The usual devices in the form of tweezers are called bipolar forceps. They are connected to the controller using a connection cable.

All components must be suitably electrically isolated and meet the required safety regulations. It should be noted that the components that come into contact with the organism, must work reliably even in a humid environment. The technology is mature today.

Not only in the diathermy procedure, the application to the patient in the operating room requires compliance with hygienic standards to safely exclude the transmission of diseases. The production of diathermy devices is therefore technically relatively complicated due to the regulations to be observed. They must be approved as reusable medical devices. The selling prices of the components are correspondingly high. Because they are multi-use medical devices, they are reprocessed after human use in accordance with the regulations for the reprocessing of medical devices. This reprocessing is costly and time-consuming, but still significantly less expensive than disposing of used components after use. Repeated treatments have been shown to cause damage to the electrical components of the diathermy devices with functional failure. The number of reprocessing cycles is therefore limited.

In a preferred embodiment, the film wrapper 1 at the distal end 4 before inserting the working tool 8th formed with blind end (blind bag).

The thus configured tubular container 8th is sterilized after manufacture with the known methods (heat, radiation, plasma, gas) in a suitable package (peel off).

For the handling of the film coating 2 is the length of the foil wrapper 1 significant. For example, it should be between about 1 m and about 5 m, preferably between about 2 m and about 3 m. For special purposes, other embodiments are possible. In any case, must be out of the insertion hole 9 protrude the diathermy cable. That is, the connection cable should be longer than the foil cover 2 , This can then be introduced or connected to the control unit of the diathermy device. The insertion opening 9 of the film coating 2 is regularly outside the sterile operating area and can be closed, for example, with clamps or tape unsterile, taking into account the emerging cable.

Likewise, diameter or cross section of the film coating 2 for the optimal function of importance. Introducing the medical instrument 8th into the interior using gravity should be ensured. Preferred are circular cross sections with diameters between about 10 mm and about 100 mm. Also foil covers 1 with conical shape, with varying diameter or with other cross-sections, for example rectangular, square, oval, elliptical or cross-shaped, may be provided. The foil cover 1 can be folded one or more times in the longitudinal and / or transverse direction, in particular in the manner of a bellows.

In the area of the insertion opening 9 the film cover has lining parts 13 . 14 on which in the representation in 1 congruent superimposed. As a result, a reinforcement or reinforcement is formed. By pressure on side edges 15 . 16 can the insertion 9 open mouthed, then on the medical instrument 8th introduce. The lining parts 13 . 14 consist for example of cardboard, plastic, metal, ceramic and / or fabric.

After use, for example, this is performed as a handpiece medical instrument 8th inside the foil cover 1 from the work tool 5 separated and removed by train to this. The container is disposed of as a disposable product. Cable and handpiece can be used again without further measures. If necessary, a wet cleaning and a wipe disinfection come into question.

A comparable device for bipolar diathermy is designed so that the foil sheath 1 is divided at one end y-shaped (not shown), with two blind ends arise. Each of these blind ends has a plug-in receptacle of the type described above and each receives a working tool, in particular an electrode. The outer parts of the electrode may be formed in the manner of a tweezers industry. The internal parts may be hollow and designed to fit snugly with the tails of commercial bipolar forceps. In this case, analogous to the above-described monopolar handpiece with cable, the non-sterile bipolar forceps with cable connection can be introduced. Using external manipulation with sterile gloves, bipolar tweezers are inserted into the cavities of the electrically conductive pins. After connecting the cable exiting through the insertion opening to the control unit, the bipolar coagulation is ready for use in the sterile field. After use, the bipolar forceps inside the foil wrapper 1 separated from the electrically conductive pins and removed with the cable.

The features disclosed in the above description, the claims and the drawings may be important both individually and in any combination for the realization of the various embodiments

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• EP 0371909 A1 [0003]

Claims (13)

Film coating ( 2 ) for protecting a rod-shaped medical instrument ( 8th ), with - a telescopically folded film envelope ( 1 ) and - an insertion opening ( 9 ) at the proximal end ( 10 ) of the film casing ( 1 ) and with leaf-shaped lining parts ( 13 . 14 ) is formed of flexible material, which are completely separated when closed and the opening of the insertion ( 9 ) by pressure on side edges ( 15 . 16 ) are spatially spread apart, characterized by a plug-in receptacle ( 3 ) at the distal end ( 4 ) of the film casing ( 1 ) is a medical working tool ( 5 ), which fits into a film envelope ( 1 ) via the insertion opening ( 9 ) medical device ( 8th ) is releasably to couple, wherein at the plug-in receptacle ( 3 ) an inner and an outer socket ( 6 . 7 ), so that the film envelope ( 1 ) is clamped in between. Foil cover according to claim 1, characterized in that the foil cover ( 1 ) in the unused initial state in the region of the distal end ( 4 ) closed is. Foil cover according to claim 1 or 2, characterized in that the film envelope ( 1 ) in one on the front of the plug-in receptacle ( 3 ) arranged portion has a perforation. Foil cover according to at least one of the preceding claims, characterized in that the section of the foil cover ( 1 ) on the front of the plug-in receptacle ( 3 ) a front opening of the plug receptacle ( 3 ) spans. Foil cover according to at least one of the preceding claims, characterized in that the plug-in receptacle ( 3 ) in a tapered portion of the film envelope ( 1 ) is arranged. Foil cover according to at least one of the preceding claims, characterized in that the inner and / or outer plug sleeve ( 6 . 7 ) are designed as a hollow cylinder. Foil coating according to at least one of the preceding claims, characterized in that the inner plug-in sleeve ( 6 ) has on one sleeve inside one or more projections and / or one or more recesses. Foil coating according to at least one of the preceding claims, characterized in that the inner plug-in sleeve ( 6 ) on a sleeve outside and / or the outer plug ( 7 ) has on one inside of the shell one or more clamping projections and / or clamping recesses. Foil cover according to at least one of the preceding claims, characterized in that the inner and / or outer plug sleeve ( 6 . 7 ) consist of a yielding material. Foil cover according to at least one of the preceding claims, characterized in that the inner and the outer sleeve ( 6 . 7 ) and the film envelope clamped in between in the region of the plug-in receptacle ( 3 ) are connected without liability. Medical instrument system, with - a film coating ( 2 ) according to at least one of the preceding claims, in which the telescopically folded film envelope ( 1 ) is at least partially deployed, - a rod-shaped medical instrument ( 8th ), which through the insertion ( 9 ) at the proximal end ( 10 ) in the film casing ( 1 ), and - a medical work tool ( 5 ), which in the plug-in receptacle ( 3 ) at the distal end ( 4 ) of the film casing ( 1 ) is inserted and in the film envelope ( 1 ) detachable to the rod-shaped medical instrument ( 8th ) couples. Instrument system according to claim 11, characterized in that the medical working tool ( 5 ) is a working electrode. Instrument system according to claim 11 or 12, characterized in that the working electrode is a diathermy electrode.

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