WO2010026090A1 - Method for sterilizing a surgical compartment and corresponding surgical compartment - Google Patents

Abstract

The invention relates to a method for providing a sterile surgical environment. According to said method, an at least partially transparent surgical compartment which comprises at least one glove extending into the surgical compartment is sterilized, preferably by irradiation with ionizing radiation. The surgical compartment is glued around the area of a body to be treated and is inflated if necessary. The invention further relates to a corresponding, preferably inflatable surgical compartment.

Description

 Method for sterilizing an operating chamber together with

operation chamber

The invention relates to a method for sterilizing an operating chamber and an operating chamber for the implementation of medical, surgical E in griffes

An operation in the medical field is performed in an operating room of a hospital to meet the required sterile requirements. The disadvantage of carrying out such operations is that a high level of technical effort is required, even for minor interventions when carrying out operations in an operating theater, it can not be ruled out that infectious agents are transmitted through the air

In order to ensure sterility in an operating room improved, according to the document EP 1 1 40 268 A2 an operating room to be hung in the operating room above the operating table is proposed, with which sterile air is blown towards the operating table. By doing so, a more sterile ambient air is achieved then, however, constantly exposed to a flow of air also increases the technical effort to be operated

DE-OS 1 091 7 1 0 discloses a walk-in climate chamber in which medical operations are to be carried out. The climate chamber thus represents an operating room which can be set up in a building in order to improve operating conditions. The technical outlay to be operated is again very large The object of the invention is to provide a simple method for the implementation of surgical procedures and an associated operating chamber

The task is performed by a procedure with the characteristics of

Main claim and solved by a device with the features of the independent claim Advantageous embodiments will become apparent from the dependent claims

To solve the task is a completely or partially transparent

A small volume in the sense of the present invention means that this chamber can not be entered. The surgical chamber is dimensioned such that an opening of the surgical chamber is fastened around a region to be treated, for example around a corresponding area of an operating chamber The diameter of the opening is therefore generally not more than 50 cm or the opening is not larger than 50 cm by 50 cm (long times width) As a rule, up to 20 cm large openings, so for example circular openings are sufficient with a diameter of up to 20 cm or up to 20 cm by 20 cm

As a rule, the diameter of a circular opening is at least 5 cm, preferably at least 10 cm, or the opening is at least 5 cm by 5 cm, preferably at least 10 cm by 10 cm, in order to be able to carry out a surgical procedure without problems

The surgical chamber comprises at least one, preferably at least two, gloves extending into the chamber or other means for external surgery within the surgical chamber. In addition, in the surgical chamber, in the event of surgery, there are means and instruments suitable for carrying out an operation These include regularly scalpel, needle, suture, tweezers, swab, anesthetic, syringe, one or more collection vessels such as blood bags, electrocautery and / or one or more Ampoules For example, in the case of an intervention, in the case of an intervention, the means and instruments required for the removal of bone marrow, ie at least one needle or syringe for aspiration, is a suitable receptacle and the required amount of an anticoagulant solution if necessary, appropriately sterilized together with the abovementioned means and instruments prior to the performance of an operative procedure, and then affixed to the body to be treated and preferably glued so that the area of the body to be treated is shielded outwardly by the operating chamber The surgical chamber then contains means and instruments for carrying out an operative procedure. The area to be treated is then shielded from the outside by the surgical chamber so that no germs can reach the area to be treated from the outside

Electrically operated instruments such as an electrocautery, which is typically used for the staunching of blood, are preferably operated by a battery in order to avoid its own power supply into the operating chamber. However, it is also possible to introduce current into the operating chamber via a cable connection. to power such electrically powered instruments as an electrocautery device

In a wall of the operating chamber, for example, a lamp can be integrated with which the area to be operated can be illuminated

The sterilization of the operating chamber can be carried out in a particularly simple and reliable manner by means of a straightening treatment. The chamber then becomes an ionizing radiation, such as, for example

Gamma radiation, X-rays or electron irradiation exposed to free the chamber of living microorganisms or living germs. In the same way, means and instruments, ie for the Needed intervention, if necessary, be sterilized immediately before the procedure

Appropriate apparatus for carrying out sterilization usually belong to the equipment of a doctor's office. There is therefore basically no need to technically upgrade in this respect

After the area of a body to be operated on has been sterilized outwards in a sterile manner, the surgical procedure can be carried out. This can be done both in an operating room and outside

Operating rooms, for example, in the practice of a doctor happen After attaching the operating chamber to a body infection carriers can no longer get from the outside to the opening point The operating conditions have been improved compared to the conditions prevailing in a conventional operating room without a large techni cal Expenditure to operate The operating persons are also exposed to any drafts or comparable disturbing boundary conditions

In one embodiment, the surgical chamber is inflatable This is then first secured in a non-aufgebla senen state on the body and then inflated sterile sterile The desired sterile conditions are further improved and that in particular compared to the aforementioned prior art Furthermore, it can then be easily determined whether the operating chamber has been secured sufficiently gastight on a body, since otherwise the volume of the operating chamber quickly decreases again. In the non-inflated state, this operating chamber can easily be sterilized by irradiation

To be able to inflate the surgical chamber in a sterile manner, the

Operating chamber in one embodiment One or more sterile valves which ensure that air blown into the chamber via the valves is sterilized. The surgical chamber can then even be inflated with the mouth In another embodiment is in the operating chamber before inflation, a gas capsule, which is opened for inflation, so broken, for example, then escapes the required amount of sterile gas in d the Operationskam mer The handling can be simplified

Nitrogen, carbon dioxide, helium or another suitable medical gas is preferably present in the gas capsule in order to be able to provide a sterile, health-friendly atmosphere in the operating chamber

Preferably, gases are provided which have an antibacterial or self-stabilizing effect. Such a particularly suitable gas is ozone, ie an irritating gas which is generally to be avoided, but whose use is made possible by the present invention. In this embodiment, it is further ensured that sterile operating conditions are ensured be optimized

In one embodiment of the invention, the opening of the

Operation chamber initially closed The opening is preferably uncovered shortly before the surgical procedure is performed. This embodiment further ensures that the surgical chamber can not be cleaned. Particularly in this embodiment, the surgical chamber, even in the closed state, contains means and instruments for the intended intervention, for example the means and instrument required for the removal of bone marrow For a doctor, such a complete set is provided in order to be able to carry out the desired procedure under minimal conditions of preparation under optimized conditions

The Versch luss the opening may consist of an adhesive film, which is also first glued together with an edge region of the operating chamber on the intended body area immediately before the Carrying out the surgical procedure, the closure is removed, thus exposing the opening

In one embodiment of the invention, the closure of the opening via a, for example, annular tear-off is materially connected to the

Operating chamber connected The tear-off edge can be formed by pre-punched, perforated rings After attaching the operating chamber to a body, the closure is separated along the tear-off edge of the operating chamber and the opening is thus exposed as desired for the implementation of the intervention

In one embodiment of the invention, the surgical chamber comprises at least two gloves or glove pairs which are of different sizes. It is then possible for two persons with different sized hands to be involved in the same operation without the intervention being impaired due to too large or too small gloves

In one embodiment of the invention, the surgical chamber comprises a sluice through which means and instruments can be brought into or out of the operating chamber during the operation. The sluice is in particular double-walled and thus has an antechamber so provided, which is outwardly and inwardly can be opened and closed An instrument is then, for example, first inserted into the antechamber from the outside and then closed Meanwhile, the access of the antechamber is closed inwards After the chamber has been closed from the outside, the access is opened inwards and so the desired means or instrument placed in the operating chamber. Conversely, a Mitlei or instrument can be removed from the operating chamber

In order to be able to open and close openings of the lock, a Velcro or zipper can suffice for this purpose. In one embodiment of the invention, at least one closure means of the lock comprises For example, a particular consisting of a film flap a self-adhesive edge region or equipped with a pressure sensitive adhesive edge region, so that at least one opening of the lock reliably sufficiently gas-tight after opening can be closed again

Also, the antechamber of the lock can be configured sterile inflatable to ensure the Steπlitatsbedingungen further improved

In the antechamber and / or in the operating chamber are in one

Embodiment means available to carry out a spray disinfection Also in this way further improved sterility contributed

In one embodiment of the invention, the surgical chamber comprises a straw-shaped or tubular access into the surgical chamber, to which a nipple can be connected. The tubular or straw-shaped access is so designed and dimensioned that it can be aspirated in a manner typically used in the medical field The closure may in turn be an externally applied, peelable, self-adhesive film. In one embodiment of the invention, the operating chamber comprises means for directing a gas through the operation chamber Means preferably comprise a pressure relief valve, via which the gas can be routed out of the operating chamber again This embodiment makes it possible, if necessary with the help of a pump via a Steπlventil pumping air into the operating chamber, wel This embodiment allows the problem-free execution or continuation of an operation in case an undesired or unpredictable pressure drop should occur in the operating chamber during an intervention. It can also be ensured by this embodiment that leaks under no circumstances Germs will occur because in the case of leaking leaks the pumped gas escapes through the leaks. If this result is to be ensured, a gas is continuously pumped into the operating chamber from the beginning

Instead of an overpressure valve, a small leak may be provided, through which gas continuously fed into the operating chamber escapes outward. The continuous gas feed is then adjusted or controlled so that a balance between gas supply and gas outflow occurs Operating chamber adjusts

If a gas due to egg ner corresponding continuous gas feed from the surgical chamber au ch out continuously out, so this is preferably done through a lock through the gas flow leading to the outside is then so improved achieved that slid over the lock means and instruments into or out without contaminating the interior of the operating chamber

In one embodiment of the invention, the operating chamber comprises a magnifying glass in order to be able to view the area to be operated through the magnifying glass. The magnifying glass can be integrated into a wall of the operating chamber or be part of a wall of the surgical camera Operating chamber The magnifying glass can consist of glass or of weight and production reasons made of transparent plastic

In one embodiment of the invention, eyelets or other means are provided on the outside of the operating chamber to which the operating chamber can be held. It is thus possible to attach the operating chamber to an outer holder, for example on a separate frame or on a hook, for example in addition to be able to ensure in this way that the Operationskam mer is kept stable in the desired position This embodiment ensures improved, that the position of the operating chamber n ichi accidentally Also, this embodiment is of particular importance when the weight of the operating chamber is so high, for example, due to an integrated interior lighting, that such Befestigungsmoghchkeit is required or even necessary

The volume of the operating chamber available for the operative intervention can vary as a function of the required amount. Basically, a volume of up to 50 liters is sufficient if the operating chamber is fastened to a body and inflated if necessary. Smaller volumes are also regularly sufficient such as, for example, up to 25 liters. The volume available in the surgical chamber is preferably at least 5 liters in order to have sufficient space for a minor surgical procedure

In one embodiment of the invention, the Operationska is already sterilized by the manufacturer and then packaged sterile. This embodiment of the invention expands the suction capacity of the surgical chamber, since then no means must be available at the site of the procedure to sterilize the surgical chamber. The surgical chamber is then intended in particular only for a single use. After performing an intervention, the surgical chamber is then not open used again

The sterile packaging may also contain sterilized means and instruments to perform a desired procedure, such as bone marrow removal The invention will be explained in more detail with reference to the figures

FIG. 1 outlines the basic principle of a person lying on a base 1, initially being suitably prepared for carrying out an operative attack. The intended location of the body is in particular suitably washed and / or disinfected. Hair may be shaved off sterilized operating chamber 3 with means and instruments therein provided for performing the surgical procedure, adhered around the area to be treated on the body The operating chamber is made of a transparent film and is baghole-shaped The opening of the "bag" can with a Alternatively, an adhesive, such as a silicone adhesive, may have been suitably applied to the body so as to adhere the bag-shaped surgical chamber to the body. Then, the surgical chamber is inflated and surgical intervention is performed with the aid of the O After completion of the operation, the operating chamber is released from the body

In FIG. 2, further details of the operating chamber from FIG. 1 are shown. In the operating chamber, for example, there is a syringe 4 required for carrying out an operative procedure. Furthermore, the presence of a flexible glove 5 extending into the operating chamber is shown Help from the outside surgical intervention can be made using a sterile valve

6, the operating chamber can be inflated via a pressure relief valve

7, gas, such as air escaping in the event of overpressure from the Operationska mmer on eyelets 8, the operating chamber can be hung to stabilize the situation The operating chamber shown further includes a sch leuchförmige supply 9, which in the chamber hinin clockwise and with a stopper 1 0 is closed The stopper 1 0 can be opened to connect a Saugeinrichtu ng The Operαtionskαmmer is provided with a self-adhesive Rαndbereich 1 1, which runs around an opening 1 2, and which has been glued to the body of the person 2

The volume of the inflated shown in Figures 1 and 2

Operating chamber is about 1 5 liters, if only minor interventions such as a removal of bone marrow should be made

By means of the invention, operations and interventions can be carried out under controlled hygienic conditions. A patient is protected against contamination from the outside. Conversely, however, the environment and, in particular, the personnel are also protected against infections and the like. The invention is therefore also of particular advantage when problematic be treated, for example, with antibiotic - resistant bacteria (eg MRSA, ESBL etc), suffer from gas gangrene, anthrax etc or who are infected with problematic viruses such as hepatitis, HIV, etc. The staff is by the invention also in the case of septic interventions (abscess etc) effectively protected

Of particular importance is the invention especially in the case of minor procedures such as arthroscopies, which are carried out in the so-called interventional trauma according to the prior art The desired protection of the patient and the surgeon can be ensured m it relatively little effort

Claims

claims Method for the creation of a sterile operating room, according to which an at least partially transparent operating chamber (3), which comprises at least one holding shoe (5) extending into the operating chamber, is sterilized, preferably by irradiation with an ionizing radiation A method according to claim 1, wherein after the sterilization, the surgical chamber (3) is fastened around a body region, in particular adhesively bonded, such that a space is created which shields the body region to the outside Method according to the preceding claim, in which, prior to gluing, means and / or instruments (4) for carrying out an operative engagement are brought into the operating chamber, so that after the attachment above the body region (2) a space is created in which the means and / or instruments are available for carrying out the surgical procedure Method according to one of the preceding claims, in which a scalpel, needle, thread, tweezers, anesthetic, syringe (4), one or more receptacles such as blood bags and / or one or more ampoules are placed therein with solutions in the operating chamber Verfa hear according to any one of the preceding claims, in which together with the surgical chamber means and / or Instru elements for the implementation of an operational E ingriffs sterilized 6. The method according to any one of the preceding claims, wherein the surgical chamber is fixed around a body region around and then inflated, 7. Method according to one of the preceding claims, in which the sterilized and attached to a body region around operating chamber is inflated by opening or breaking a gas capsule and with air through a Steπl valve (6) therethrough. 8. The method according to any one of the preceding claims, wherein the surgical chamber is packaged sterile after sterilization. 9. The method according to any one of the preceding claims, wherein the surgical chamber is removed from a sterile packaging prior to sticking to a body. 1 0. A method according to any one of the preceding claims, wherein an opening of the operating chamber is opened prior to performing an operative procedure and so the access to the operating area of a body is exposed. 1 1. Method according to one of the preceding claims, in which ozone is pumped into the surgery chamber. 1 2. The method according to any one of the preceding claims, in which continuously a gas, in particular air is pumped into the operating chamber, which can escape via a pressure relief valve (7) from the operating chamber 3. The method according to any one of the preceding claims, wherein a gas is continuously fed via a Schle use the operation chamber from the operating chamber out. 4. The method according to any one of the preceding claims, wherein the operating chamber is attached hanging, in particular on a frame. 5. A method for the protection of personnel in a medical intervention, in which an at least partially transparent operating chamber (3) comprising at least one glove (5) extending into the operating chamber is fastened to a body of a patient to be treated such that the body area to be treated is shielded from the personnel. 6. Operating chamber (3) for carrying out a medical, operational E ing riffs, which is at least partially transparent and which comprises at least one extending into the operating chamber glove (5). 7. Operating chamber according to the preceding claim with an internal useful volume of not more than 50 liters, preferably not more than 20 liters. 8. Operating chamber according to one of the two preceding claims with an opening (1 2) of not more than 50 cm by 50 cm, preferably of not more than 20 cm ma l 20 cm or with a diameter of not more than 50 cm, preferably not more than 20 cm. Operαtionskαmmer according to one of the preceding device claim with an opening (1 2), the edge region (1 1) is provided with an adhesive, in particular with a pressure-sensitive adhesive for adhering the opening to a body Operating chamber according to one of the preceding device claims with means for inflating the surgical chamber, in particular with a Steπlitatsventil (6) and / or a gas-filled capsule The surgical chamber of any preceding apparatus claim, wherein the surgical chamber is germ-free The surgical chamber of any preceding apparatus claim, wherein the surgical chamber is packaged sterilized and sterilized Operating chamber according to one of the preceding device claims with means and instruments in the operating chamber for carrying out an operative procedure, in particular scalpel, needle, thread, tweezers, anesthetic, swab, syringe (4), one or more collection vessels such as blood bags and / or one or more several ampoules with therein solution en Operating chamber according to one of the preceding device claims, which consists entirely or at least predominantly of a plastic film Operating chamber according to one of the preceding device claims with a lockable pre-chamber designed as a lock 26. Operαtionskαmmer according to one of the preceding device claims with two different sized gloves. 27. Operating chamber according to one of the preceding device claim with a closable opening (1 2) for the implementation of a surgical procedure. 28. Operating chamber according to one of the preceding device claims with a tubular access (9) into the operation chamber, 29. Operating chamber according to one of the preceding device claims with a pressure relief valve (7) for the escape of gas from the operating chamber when an overpressure occurs. 30. Operating chamber according to one of the preceding device claims with externally mounted eyelets (8).