DE102007047623A1 - Method for packing medical products in a sterile manner comprises inserting first medical products into a gas-tight protective packaging, closing, inserting into a final packaging with a second medical product and further processing - Google Patents

Abstract

The present invention relates to a method and a device for the sterile packaging of a plurality of medical devices. Compared to the methods and devices known from the prior art, the object of the present invention is to provide a simplified packaging and a simplified method for the sterile packaging of a plurality of medical devices, a part of which may not be sterilized with ETO. This object is achieved by a method for sterile packaging of a plurality of medical devices (3, 4 ', 5') with the steps of introducing a first medical device (4 ', 5') into a gas-tight protective packaging (2 '), closing the gas-tight Protective packaging (2 '), introducing the gastight protective packaging (2') with the first medical device (4 ', 5') and at least one second medical device (3) into a final package (1), closing the final packaging (1) and sterilizing the protective packaging (2 ') and the second medical device (3) in the final package (1') with the aid of a gas. The object is further achieved by a device for sterile packaging of medical devices (3, 4 ', 5') with a final packaging (1) and a gastight protective packaging (2 '), the protective packaging (2') being in the final packaging ( 1) is arranged, that the protective packaging (2 ') forms a first packaging space for receiving a first medical device (4', 5 ') and the final packaging (1) a ...

Description

The The present invention relates to a method and a device for the sterile packaging of a plurality of medical devices.

It is known, medical devices, such as surgical (OP) covers, Scalpels and sutures using ethylene oxide (ETO for short) to sterilize. Ethylene oxide kills Bacteria, mold and fungus and can therefore be used for sterilization also be used by heat-sensitive substances. It is it's common the medical devices in their final packaging, in which they are sent to consumers, especially hospitals and doctors, delivered be able to contribute, seal these, and medical devices then sterilize in the final package with ETO. That way is guaranteed that both the medical devices as well as the surrounding packaging material get sterile from the inside to the consumers.

Next the packaging of individual medical devices in separate packaging, for example, a hypodermic syringe in a deep-drawn plastic shell with a tear-off lid from me medical paper, it is also known, various Compilations of a plurality of medical devices into a single Final packaging and sterilize in the final packaging with ETO. Such compilations are known in particular as surgical sets, in those in a single final package for a specific operation required Medical devices are included. To prepare the operation must then in Operating room will be opened only a single packaging and all the required medical devices can taken at once and for the operation be prepared.

Certain Medical devices, especially special sutures, swabs and However, medications are allowed can not be sterilized with ETO as they may ETO absorb so that after the sterilization ETO emerges as residual gas from these materials. This is to be avoided, since ETO also applies to the human organism toxic and above is carcinogenic.

Therefore These ETO resorbing medical devices are mostly with the help sterilized by γ radiation, placed in a second final packaging and closed. following Be the first sealed end-of-line packaging that is ETO-sterilized Contains medical devices and the second sealed end package, which is the example with γ-radiation contains sterilized medical devices, brought together and, for example by gluing on their outsides connected with each other. Alternatively, the two sealed end packs sold separately as individual products and loose to the consumer merged.

The Production of such sets proves to be expensive and costly, since the two components d. H. the already closed first and second end packages, subsequently interconnected Need to become. About that In addition, it can be used during transportation and also on site for detaching the first come from the second final packaging, so that the sets the operating room possibly only incomplete to reach. Are the first and second end packages with the sold separately in them, both must Packs must be ordered separately and stored. In separate Deliveries of the two end packaging can cause confusion come, so that, for example time delays in Operation sequence can occur. Therefore, the OR staff is providing in the operating theater of an overall product to simplify the workflows preferred.

Opposite this Prior art, it is an object of the present invention a simplified packaging and a simplified procedure for sterile packaging of a plurality of medical devices, of which a part may not be sterilized with ETO provide.

These The object is achieved by a Method for sterile packaging of a plurality of medical devices solved, comprising the steps of introducing a first medical device in a gastight protective packaging, sealing the gastight protective packaging, Introducing the gas-tight protective packaging with the first medical device and at least one second medical device in a final package, close the final packaging and sterilization of the protective packaging and the second medical device in the final packaging with the aid of a gas.

Medical Devices For the purposes of the present application, all medical and medical technology Products as used to treat a patient in the human or veterinary medicine are needed, this includes both medical instruments, such as As scalpels, needles, scissors, surgical instruments, Syringes, catheters, tubes, etc. as well as medicines or drugs, Sutures and, for example, covers and bandage material.

In particular, the first medical device is a product which must not be sterilized with gas, in particular ethylene oxide. These are on the one hand due to appropriate regulations and guidelines medicines or pharmaceuticals and on the other hand such products, which the Resorb gas used for sterilization, so that the surface of the products subsequently emits residual amounts of gas continuously.

These not to be sterilized with a gas products are in advance with an alternative method, in particular with γ-radiation, sterilized and in the protective packaging introduced. This is then sealed gas-tight. Subsequently, the first medical device in the gas-tight sealed Protective packaging with one or more other medical devices brought together, placed in a final package and after the close the final packaging in this with the help of a gas, in particular with ethylene oxide, sterilized. Due to the gastight protective packaging, which preferably for Ethylene oxide is dense, passes during Do not sterilize with gas the first medical device in contact with the gas, but only the outside of the protective packaging and the second or the other medical devices sterilized.

The inventive method and the packaging according to the invention enable to provide a single product in a single end-package, which all for example for a Surgery required medical devices. Because the final packaging all Contains medical devices, The purchase will be easier to manage the order at only allows a supplier. In front Only one package needs to be stored and provided which in turn, for example, the workflow in an operating room simplified. About that In addition, the inventive method help and the corresponding packaging largely to avoid confusion.

The inventive method is in one embodiment for the Sterilize with ethylene oxide suitable, with the protective packaging for ethylene oxide is tight.

The End packaging is in one embodiment for the sterilizing Gas, especially ethylene oxide, permeable, while for other gases and gas mixtures, especially air, impermeable is. That way you can the medical devices placed in the final packaging in the closed Final packaging can be sterilized with ethylene oxide without the Medical devices succeed in losing your sterility again.

The The aforementioned object is also achieved by a device for packaging solved by medical devices with a final packaging and a gastight protective packaging, wherein the protective packaging is arranged in the final packaging, that the protective packaging a first packaging space for receiving a first medical device forms and the final packaging forms a second packaging space, in which the gas-tight protective packaging is arranged and in the outside the gas-tight protective packaging a second medical device can be received is.

In an embodiment the invention is the protective packaging at least in sections from a metal-coated plastic, preferably one with aluminum vapor-deposited plastic film, produced. Most Plastic materials as such prove to be gases, in particular ethylene oxide, as permeable, so that one additional metal layer on the surface the plastic must be provided to prevent that gas used for sterilization into the protective packaging diffuses and so the first medical device but with the gas in Contact is coming.

In a further embodiment the protective packaging is at least partially made of metal, preferably Aluminum, manufactured.

there are natural also embodiments possible, in which the protective packaging combinations of the aforementioned Has materials. An embodiment has a basic body from pressed Aluminum, which closed with the aid of an aluminum-coated plastic film is. The plastic film is expediently designed as a tear-off film.

In an embodiment the invention, the protective packaging has a substantially hollow cylindrical Sleeve with two ends and at least one lid, wherein at least one End of the sleeve can be closed gas-tight with the lid. Both the sleeve as also the lid can alternatively either of a metal coated plastic or completely made of metal, preferably aluminum.

Meanwhile in one embodiment the hollow cylindrical sleeve one fixed to one end of the sleeve with the sleeve connected ground up while the other of the sleeve with the lid is also closed gas-tight.

In an embodiment is at one end of the sleeve provided a screw thread, wherein the lid is also a screw thread has, so that sleeve and Lid gas-tight connectable to each other.

In an embodiment the invention, the protective packaging is a sleeve made of aluminum with a bottom and a screw thread at its open end, wherein the lid is also made of aluminum and has a screw thread.

The Final packaging is in one embodiment preferably made of medical paper, d. H. one with a plastic coated paper, or at least partially made of a plastic produced. Tyvek (registered Brand) available from Du Pont.

The Device according to a embodiment The present invention is particularly for an operation set with a Majority of medical devices.

Further Advantages, features and applications of the present The invention will be apparent from the following description of preferred embodiments and the associated Figures clearly.

1 schematically shows the structure of a package according to a first embodiment of the invention.

2 shows an alternative embodiment of the package according to the invention.

3 shows the protective packaging according to the alternative embodiment of the present invention 2 ,

4 shows a flow chart of the method for sterile packaging of medical devices according to an embodiment of the invention.

In 1 schematically a first embodiment of the invention is shown. The packaging has a final packaging 1 as well as a protective packaging 2 inside the final packaging 1 on. The final packaging 1 consists of a medical paper which forms a bag-like container as a packaging space. The inside of the packaging space of the final packaging 1 arranged objects 2 . 3 be after closing the final packaging 1 and kept sterile once in the packaging room. In addition to the protective packaging 2 is in 1 an example of a scalpel 3 in the packaging room of the final packaging 1 and outside the protective packaging 2 intended. 1 shows the final packaging 1 in the still open condition before sealing and subsequent sterilization with ETO.

The protective packaging 2 inside the final packaging 1 In the illustrated embodiment, it is a welded bag of aluminum vaporized polyethylene. This forms a further packaging space which is separated from the packaging space of the final packaging. Due to the metal evaporation is the protective packaging 2 gas-tight. Inside the protective packaging 2 , ie in their packaging space, are medical devices, exemplified here a pack of drugs 4 as well as sutures 5 , contain. These medical devices 4 . 5 should not due to their ethylene oxide resorbent property with the ethylene oxide to sterilize the other contents 3 the final packaging 1 get in touch. Therefore, the items were 4 . 5 in protective packaging 2 before closing the protective packaging 2 and the introduction into the final packaging 1 sterilized using γ-radiation.

In 2 an alternative embodiment of the packaging is shown. This is like the packaging 1 a final packaging 1 from medical paper. In contrast to the presentation 1 is in 2 the final packaging 1 shown in the closed state. Inside the final packaging 1 is as before as an example of a medical device a scalpel 3 contain. Next to the scalpel 3 is in the final packaging 1 a protective packaging 2 ' with a medicine box 4 ' as well as sutures 5 ' , which in turn may not be sterilized with gas, provided in their interior.

Unlike the in 1 embodiment shown is the protective packaging 2 ' in this embodiment, an aluminum sleeve by means of a screw cap 6 is sealed gas-tight.

3 shows the protective packaging 2 ' out 2 in detail. The protective packaging 2 ' has a basic body 7 made of aluminum sheet, which forms a substantially hollow cylindrical shape. In these inner medical devices can be introduced, which should not come into contact with the ethylene oxide. The main body 7 has a bottom at one end 8th on or is integrally connected to this. In contrast, the other end has an external thread 9 on which the lid 6 that has a matching internal thread 10 has, can be screwed so that the lid 6 the main body 7 the protective packaging 2 ' gastight closes.

Here, the main body 7 as well as the lid 6 the protective packaging 2 ' in another embodiment, not shown, have any other shape, as long as their function, ie the protection of the medical devices contained in the protective packaging from the sterilization gas, is maintained.

To illustrate the method according to the invention for the sterile packaging of medical devices is in 4 a flow chart illustrating the method for packaging according to the representations of 2 and 3 shows. In step 100 those medical devices which must not be sterilized with ethylene oxide, in this case a wound treatment drug, and an ethylene oxide resorbent suture, with the aid of γ radiation together with the protective packaging 2 ' sterilized. After that, in step 101 the γ-sterilized medical devices in the protective packaging 2 ' introduced and this in step 102 with the help of the lid 6 sealed gas-tight. Below are the protective packaging 2 ' as well as the other medical devices 3 in the final packaging 1 introduced (step 103 ) and the final packaging 1 is closed (step 104 ). In the final step 105 will be the final packaging 1 together with the medical devices contained therein 3 and the protective packaging 2 ' sterilized by means of ethylene oxide. This is done sterilizing the medical devices 3 and the protective package with ETO through the sealed end package. In this way, the sterile products can now be transported to the end user, in this case in the operating room of a hospital, without losing their sterility.

For purposes the original one Revelation is noted that all features as they are from the present description, the drawing and the claims for a To open up a specialist, even if they are specific only in connection with certain others Characteristics have been described, both individually and in any Compilations with other features disclosed herein or Feature groups are combinable, unless this is expressly excluded was or technical conditions such a combination impossible or make pointless. On the comprehensive, explicit representation of all conceivable combinations of features is here only for brevity and omitted for the readability of the description. While the Invention in detail in the drawings and the foregoing description has been shown and described, this representation takes place and Description is exemplary only and is not intended to be limiting of Scope as he is defined by the claims. The invention is not limited to the disclosed embodiments.

modifications the disclosed embodiment are for the skilled artisan apparent from the drawings, the description and the appended claims. In the claims includes the word "do not have" other elements or steps out and the indefinite article "a" or "an" includes one The majority are not. The terms used in the claims First and second medical devices preclude the presence of others Medical devices are not, but merely serve to distinguish them. The mere Fact that certain Characteristics claimed in different claims excludes their Combination is not enough. Reference signs in the claims are not as a restriction of the protected area.

1

terminally

2

protective packaging

2 '

protective packaging

3

scalpel

4, 4 '

drugs

5, 5 '

sutures

6

screw

7

body

8th

ground

9

external thread

10

inner thread

100

γ-sterilization a first medical device

101

bring a first medical device in the protective packaging

102

Closing the protective packaging

103

bring the protective packaging and other medical devices in the final packaging

104

Closing the terminally

105

Sterilize protective packaging and other medical devices in the final packaging with ETO

Claims (12)

Method for sterile packaging of a plurality of medical devices ( 3 . 4 . 4 ' . 5 . 5 ' ) with the steps of introducing a first medical device ( 4 . 4 ' . 5 . 5 ) in a gastight protective packaging ( 2 . 2 ' ), Closing the gastight protective packaging ( 2 . 2 ' ), Introduction of the gastight protective packaging ( 2 . 2 ' ) with the first medical device ( 4 . 4 ' . 5 . 5 ' ) and at least one second medical device ( 3 ) in a final package ( 1 ), Closing the final packaging ( 1 ) and sterilizing the protective packaging ( 2 . 2 ' ) and the second medical device ( 3 ) in the final packaging ( 1 ) with the help of a gas. Method according to claim 1, characterized in that the first medical device ( 4 . 4 ' . 5 . 5 ' ) in an ethylene oxide-tight protective package ( 2 . 2 ' ), using ethylene oxide for sterilization. A method according to claim 1 or 2, characterized in that before sealing the gas-tight protective packaging ( 2 . 2 ' ) the first medical device ( 4 . 4 . 5 . 5 ' ), preferably by means of gamma radiation. Device for the sterile packaging of medical devices ( 3 . 4 . 4 ' . 5 . 5 ' ) with a final packaging ( 1 ) and a gastight protective packaging ( 2 . 2 ' ), the protective packaging ( 2 . 2 ' ) in the final packaging ( 1 ), that the protective packaging ( 2 . 2 ' ) a first packaging space for receiving a first medical device ( 4 . 4 ' . 5 . 5 ' ) and the final packaging ( 1 ) forms a second packaging space in which the gas-tight protective packaging ( 2 . 2 ' ) and in which outside the gas-tight protective packaging ( 2 . 2 ' ) a second medical device ( 3 ) is receivable. Device according to claim 4, characterized in that the protective packaging ( 2 ) is at least partially made of a metal-coated plastic film. Device according to claim 4 or 5, characterized in that the protective packaging ( 2 ' ) is at least partially made of metal, preferably aluminum. Device according to one of claims 4 to 6, characterized in that the protective packaging ( 2 ' ) a substantially hollow cylindrical sleeve ( 7 ) with two ends and a lid ( 6 ), wherein at least one end of the sleeve ( 7 ) with the lid ( 6 ) is gas-tight closable. Apparatus according to claim 7, characterized in that at one end of the sleeve ( 7 ) a screw thread ( 9 ) is provided and the lid ( 6 ) a screw thread ( 10 ), so that sleeve ( 7 ) and lid ( 6 ) are gas-tight connected to each other. Device according to one of claims 4 to 8, characterized in that the final packaging ( 1 ) is at least partially made of medical paper. Device according to one of claims 4 to 9, characterized in that the final packaging ( 1 ) is at least partially made of a plastic material. Operations set with a first and a second Medical device and with a device for sterile packaging of medical devices according to one of claims 4 to 10. Use of a gas-tight protective packaging for a first Medical device in a final package for at least a second outside the protective packaging arranged medical device.