CN101132826A - Packaging for medical devices - Google Patents

Abstract

The present invention provides an assembly for preparing a medical device, in particular a urinary catheter, by releasing a fluid medium onto the medical device. The medical device is packaged in a package containing a fluid medium, wherein the fluid medium is confined in one compartment. In order to ensure a pre-preparation of the medical device, the package is preferably adapted to open the compartment and the package simultaneously in one and the same opening action, to open the compartment at the latest when the package is opened. Thus, removal of the medical device from the package requires opening the compartment and the medical device is automatically wetted as part of the opening process.

Description

Packaging of medical devices

technical field

The present invention relates to an assembly for wetting a medical device such as a catheter, such as a urinary catheter, with a fluid medium such as an antimicrobial agent or a lubricant or a salt for activating a hydrophilic low friction surface aqueous solution. The assembly includes a package containing a medical device and a compartment containing a fluid medium such that the fluid medium does not come into contact with the medical device.

Background technique

Typically, medical devices such as catheters must be wetted with a fluid medium prior to use. For example, it is often desirable to wet a medical device with an antimicrobial agent or a substance used to control friction on the surface of the medical device. In one embodiment, a medical catheter, such as a urinary catheter used to empty the bladder, must be inserted into the body through a natural or artificial body passage, such as the urethra. To facilitate insertion, a friction-reducing substance is often used on the catheter. In the remainder of this specification, the invention is described in connection with urinary catheters, but other applications of the invention, such as catheters for blood vessels, ventilation of the respiratory system, etc., will be readily apparent to those skilled in the art.

Catheters to empty the bladder are used as intermittent and indwelling or permanent insertion catheters. Often, patients with urinary retention, such as hemiplegic or quadriplegic patients who urinate uncontrollably and voluntarily, use urinary catheters. Urinary catheters have been developed that facilitate insertion of the catheter into the body and have low friction surface properties with body tissue, such as catheters with lubricated surfaces or surfaces with hydrophilic surface coatings.

Typically, urinary catheters are distributed in hermetically sealed and sterile packages which, in addition to the catheter, may contain a substance that activates the low-friction properties of the surface of the catheter. Some existing packages deliver the substance in a compartment separating the substance from the catheter, such as in a pouch or a small plastic bottle. Before the catheter is inserted into the body, the user must manipulate and empty the compartment in order to bring the contents into contact with the catheter. Manipulating the compartments in the package can be difficult because the user's dexterity is sometimes reduced.

Contents of the invention

It is an object of embodiments of the present invention to facilitate wetting of medical devices, such as preparing a urinary catheter prior to its insertion into the body. Therefore, the present invention provides an assembly of the kind mentioned in the technical field and also includes opening means adapted to combine an opening action so that both the package and the compartment are opened. As the compartment is emptied due to the combined opening action as part of a complete opening procedure, the risk of misuse, eg forgetting to use the fluid medium before using the medical device, is reduced.

A combined open action can be:

a) the user uses a separate grip in the assembly, such as squeezing, pressing or bending the assembly, to open the package and the compartment;

b) The user moves a single part relative to another part of the assembly, so that this moving action opens the pack and the compartments simultaneously or one after the other. In one embodiment, the components in the assembly are moved backwards and/or forwards in one direction, or rotated clockwise and/or counterclockwise, thereby opening the package and the compartment. The two parts of the assembly that move relative to each other are for example two parts of a package made of flexible material such as foil material, or the two parts are two separate parts, for example during dispensing of the assembly to the user , the parts are joined together in the form of a breakable adhesive joint. In another embodiment, relative movement between the catheter and the package opens the compartment. or

c) access to the medical device by means of a predetermined method of opening the package, which automatically causes the compartment to open. For example, packaging may include cutting, tearing or rupturing features. This feature is, for example, simply an indication on the front surface, such as a line along which the user wants to open the package. The compartment is arranged such that the tearing, cutting or rupturing feature is also used to open the compartment by the same opening action.

As used herein, "open package" means that the package is broken, ruptured, cut, twisted, or opened in any manner that is structurally prepared to make the medical device accessible.

Packaging contains a medical device in the sense that at least a part of the medical device is protected in the space formed by the packaging, usually that part of the medical device which remains sterile until it is used. The packaging is any suitable type of packaging for the medical device in question, typically formed by joining sheets of foil material, or eg of a hose or tube of polymeric material.

By the fluid medium not being in contact with the medical device is meant that the fluid medium cannot interact with the medical device until the compartment is opened.

Opening the compartment means that the fluid medium can be released from the compartment and thus interact with the medical device.

The medical device may be of any type, and as previously stated, the medical device is a urinary catheter of the type known in the art, i.e. comprising an elongated body extending between an insertable tip at a proximal end and an axially opposite distal end , the distal end includes, for example, a connector. The tip may form an opening which is the opening for the discharge of bodily fluids, such as urine, into the inner catheter from the body through the catheter to a disposal site. The connector can be used to attach to a collection bag, or to a hose that is an extension of a urinary catheter. The type of urinary catheter may also form an axially extending outer groove that guides urine along the outer surface.

The surface of a medical device may, for example, be coated with a hydrophilic coating activated by a swelling medium, such as a saline solution.

The compartment may be a sachet forming part of a package, a bottle, a pocket, or any similar device for containing a fluid medium so that the medium does not come into contact with the urinary catheter. In one embodiment, a urinary catheter is packaged with several compartments each containing a fluid medium that, alone or in combination with fluid medium in other packages, provides the desired treatment of the medical device. One compartment contains, for example, an antimicrobial agent and the other compartment may contain a friction-reducing substance.

In particular, the compartment may comprise an outlet, for example formed at a weak point of the compartment which is prone to rupture, or by other means enabling the fluid medium to be evacuated onto the urinary catheter. Weak points may for example consist of welds which are weak or comprise weak channels, or weak points of reduced wall thickness of the compartment, or of indentations provided on the edges of the compartment to cause pressure failure thereof. Additionally, or as an alternative to a point of weakness, a cutting edge is provided on the inner surface of the package to rupture the compartment when it comes into contact with the cutting edge.

The fluid medium can be a liquid medium, a gas or a powder. For example, the liquid medium may be a low surface friction saline solution or similar medium used to activate a hydrophilic medical device, or a lubricant in which the liquid is a hydrogel. The fluid medium also includes active substances that treat the organism, or the medium may include antimicrobial agents. For example, the medium may be an aqueous solution of an antibacterial agent such as chiorhexidine digluconate, chiorhexidine dihydrochloride, benzalkonium chloride, peroxide Hydrogen peroxide, silver chloride, silver sulfadiazine, silver hydantoin, silver 5-5 dimethylhydantoinate (sliver-5, 5dimethylhydantoinate) or a combination thereof. In another embodiment, the assembly contains, for example, a first substance in the form of a liquid, a gas or a powder to be contained in contact with a medical device, and the compartment, for example, contains another substance that is a liquid, a powder or a gas, when the compartment Upon opening, the second substance reacts with the first substance to form an active substance that provides the desired function, eg friction reduction or disinfection of the medical device.

The assembly may be made such that the compartment and the package are opened substantially simultaneously, for example breaking the seal of the package while opening the compartment. But it is also possible to open the compartment before opening the package, thereby allowing the fluid medium to wet the surface, or to interact with the surface even before the package is opened. Alternatively, the compartment is only opened after the packaging has been opened, for example because the medical device is to be removed or partially removed from the packaging.

The assembly may also have an easy-to-grasp shape, especially for users with reduced dexterity. The opening means and possibly other parts of the assembly can be made ergonomically shaped and made of a synthetic material such as a soft rubber material or have a surface texture such as knobs, bumps for improved handling. Ribs, ribs, or dents. Improved handling is achieved eg by providing a large area of friction or by providing a soft deformable outer surface on which a hand grip can secure the assembly and at least the opening means of the assembly. In a particular embodiment, the combined opening action is facilitated by moving one part of the assembly relative to the other part. The part preferably protrudes from the package for opening purposes by pushing the part against an obstacle such as a wall or wash basin.

In order to establish contact between the fluid medium and the medical device, for example for wetting a urinary catheter with an antibacterial or lubricating liquid medium, the outlet is preferably located near the medical device, and preferably the outlet includes a Conduit for fluid flow from chamber to medical device. If the medical device is a urinary catheter inserted into the living body, the outlet is preferably placed near or possibly in direct contact with the insertable portion of the catheter, so that the fluid medium acts directly on the portion of the catheter that needs to act on the fluid medium. In this way, contact between the fluid and the portion of the catheter that is touched by the user is prevented.

To further prevent contact between the fluid and specific areas of the medical device, the assembly also includes a spacer, for example in the form of a gasket, septum, etc., placed in the package and sealed between the inner wall of the package and the outer wall of the catheter, thereby Fluid is prevented from passing between the surface of the catheter and the surface of the package. A gasket may be a ring-shaped member placed around a medical device. The gasket can be made of any suitable elastic material such as rubber or silicone. The gasket even forms part of the medical device or forms part of the packaging, such as forming a protrusion on the surface of the medical device or packaging. If the medical device is a urinary catheter, it is advantageous to prevent fluid from entering the inner catheter of the catheter. For this purpose, for example, the inlet provided on the insertable proximal end of the urinary catheter can be sealed with a sealing structure which forms part of the packaging and which can be used when the insertable part of the urinary catheter emerges from the packaging or When the catheter is completely removed from the package, it is automatically removed from the catheter.

The compartment may remain fixed in a position that is above the medical device during normal handling of the assembly. In this way, gravity can be used to force fluid flow across the entire medical device insertable surface. In order to facilitate the arrangement of the assembly in a desired orientation to effect the gravity-assisted diffusion of the above-mentioned fluids, the assembly may include a suspending structure, which may be a hook, hole, adhesive strip or similar structure, which facilitates suspending the fluid in an orientation. An assembly in which a compartment is located over a medical device or at least a portion of a medical device that is intended to come into contact with a fluid during the preparation of the medical device. Furthermore, the compartment may be located at the level of the connector or above the connector if the medical device is a urinary catheter. During use, the connector portion of the urinary catheter is generally grasped by the user to control the insertion or removal of the catheter from the body, and the dry connector portion facilitates this. To prevent fluid from coming into contact with the connector, the package may include an elongated sleeve that just encloses the insertable portion of the catheter, and to release fluid directly onto the catheter at a location remote from the connector, the outlet may be located within the sleeve. In one embodiment, the volume of the cannula is in the range of 1-20 times the volume of the insertable part of the urinary catheter, such as in the range of 1-10 times or in the range of 1-5 times. The compartment preferably contains a sufficient amount of fluid medium to achieve the desired effect on the medical device, eg moistening at least the insertable portion of a urinary catheter.

As noted above, the gasket prevents fluid from contaminating portions of the medical device that are not intended to come into contact with the fluid, such as preventing fluid from flowing from the insertable portion of the catheter to the connector portion of the catheter. In this embodiment, the main part of the compartment is on one side of the gasket and the outlet is on the other side of the gasket, so that fluid can be stored in a location near parts of the medical device that are not intended to be wetted, e.g. Immediately adjacent locations, for example near the connector portion of the urinary catheter, while fluid release is adjacent to a portion intended to come into contact with the fluid, such as near the insertable portion of the urinary catheter.

The package may comprise a container portion and a removable closure which interacts with the compartment to open the compartment when the closure is moved relative to the container. The closure and container can be connected by screwing, by removable sealing tape, adhesive, frictional resistance between the parts, or by any type of joint between the two parts. Similarly, the container part and the detachable closure can be separated prior to use by breaking, twisting, twisting, breaking, squeezing or cutting the parts. Closed containers and closures are generally distributed under sterile conditions.

In one embodiment, the closure forms part of, or is adhesively connected to, the compartment so that the compartment ruptures and opens when the closure is removed from the container. In an alternative embodiment, the closure body is positioned relative to the compartment such that the closure body can press against the compartment and thus rupture the compartment. To facilitate rupturing the compartment, the cutting edge may be placed within the container or closure, or the cutting edge may form part of the container or closure.

The closure may be designed such that opening of the compartment is required to release the closure from the container. The opening device can thereby be adapted to open the compartment at the latest at the same time as the packaging is opened. In one embodiment, release of the closure may require movement of the closure towards the compartment. In another embodiment, the closure and compartment are connected such that the closure can be released without breaking the compartment. Do not remove from container. In this way, the user also opens the medical device in a predetermined manner by opening the compartment, or at least accesses the medical device, so that the user can remove the medical device during a procedure in which the fluid medium has been released on the medical device.

If the medical device is elongated, as is the case with most catheters, the compartment may fit right around the catheter, thus allowing even wetting and saving space. For example, the compartment may be elongated, either disposed along the length of the medical device or wrapped around the medical device, or the compartment may include a through-hole through which the medical device can extend outwardly. The compartment may for example be annular.

The assembly may form a space for storing one or more medical devices and/or one or more compartments. In one embodiment, the assembly includes a plurality of individual and spaced-apart packages for containing a plurality of spaced apart medical devices, or a plurality of medical devices, each of which is at least partially Separated from another medical device. In this embodiment, a separate compartment may be provided with release means for releasing the fluid medium into one or all of the packages during the opening action of the package, or the compartment may be provided in connection with each package to individually moisten the individual compartments. Opened medical device.

In a second aspect, the invention provides a method of wetting a medical device with a liquid medium contained in a compartment, the method comprising placing the medical device and the compartment in a package such that the liquid medium and the medical device are not directly contact steps. The method also includes the step of opening the compartment and the package by the same opening action, for example in any of the ways described above.

In a third aspect, the invention provides a compartment for an assembly according to the first aspect of the invention, the compartment being adapted to enclose a medical device in a packaging.

Any feature described in connection with the first aspect may also be applied in the second and third aspects.

Description of drawings

Figure 1 shows the sequence of opening of components according to the invention;

Figure 2 shows the opening sequence of an alternative embodiment of the invention;

Figure 3 shows the opening sequence of an alternative embodiment of the invention;

Figure 4 shows a top view of an assembly according to the invention;

Figures 5a and 5b show different sealing joints between the container part and the top of the assembly;

Figure 6 shows the assembly with the gasket;

Figure 7 shows an enlarged view of the top of the assembly shown in Figure 6;

Figure 8 shows an applicator using the top as a catheter for clean handling; and

Figure 9 shows an alternative embodiment of the assembly.

Detailed ways

The further scope of application of the present invention can be understood more clearly from the following detailed introduction and specific examples.

Figure 1 shows the wetting of components of a medical device with a fluid medium. The assembly comprises a package comprising a closure 2 and a container comprising an elongated sleeve 3 . The elongated sleeve 3 just seals the insertable part of the catheter and is connected with the cup-shaped top 4 which opens upward. The package accommodates a catheter 5 and also a compartment 6 with a liquid medium, indicated by an air bubble 7 . The liquid medium remains isolated from the catheter until the compartment is opened and emptied prior to use. The urinary catheter includes a proximal end 8 formed to be inserted into the body of a user, and includes an inlet 9 for expelling body material into the catheter within the catheter. The opposite distal end of the catheter has a connection portion 10 from which bodily fluids can be drained to a disposal site. In order to reduce the amount of liquid medium that must be used to wet the insertable portion of the catheter, the container forms an elongated sleeve that just seals off the proximal end of the catheter.

FIG. 1 shows four steps in the opening process of the assembly 1 . In FIG. 1 a the urinary catheter is eg hermetically sealed in a sterile package. In FIG. 1 b , the user breaks the gap between the closure 2 and the container 3 , 4 by pushing the closure in the direction indicated by the arrow 11 , whereby the edge 12 of the closure pushes the compartment in the direction of the sharp cutting edge 13 . seal. After this breaking of the seal, the compartment is emptied, whereby the liquid (indicated by the gas bubbles) flows down into the elongated sleeve 3 . In FIG. 1c the closure body has been removed from the container to enable removal of the catheter from the packaging. To remove the closure, the user pulls the closure upwards in the direction opposite to the direction indicated by the arrow 11 , or the user breaks the top 14 of the closure, separating it from the bottom 15 . The disclosed assembly includes additional opening features including a seal 16 such as a thin foil bonded to the top surface of the enclosure to cover the opening 17 . During the initial push of the closure in the direction indicated by arrow 11, the distal portion of the catheter pierces the foil or keeps the foil out of contact with the closure, so that the catheter can be removed from the package without further steps. Unpack. The top 14 of the closure is made of a soft flexible material which can be squeezed into contact with the catheter using only finger pressure and which can constitute an applicator which facilitates contamination-free handling of the catheter tube without direct contact between the user's hand and the catheter, see Figure 8.

Due to the distance between the catheter and the foil and the distance between the closure and the compartment, the compartment is opened before or at least simultaneously with the package. This prevents attempts to remove the catheter from the package before the compartment is opened and ensures that the catheter is moistened prior to use.

Figure 2 shows an alternative embodiment of the assembly. In this embodiment, the closure is connected to the container via a threaded connection 18 . To open the package, the user twists the closure as far as it will go in the direction indicated by arrow 19 until the top 20 of the closure breaks away from the bottom 21 . At this point, the compartment is pushed down onto the sharp edge 22, thereby opening the compartment. The downward travel limit of the closure may be limited, for example, by the threads of the inner surface of the container and/or the length of the threads of the outer surface of the closure, or the travel may pass through the side 23 of the closure to the bottom surface 24 of the surface on which the compartment 25 rests. to limit. Compared with the embodiment shown in FIG. 1 , the compartment is adjacent to the catheter at a position away from the connecting portion 26 of the catheter so that the liquid substance is released closer to the insertable top 27 of the proximal end to be released to the catheter. Insertion into that portion of the patient's urinary catheter where reduced friction and/or improved antimicrobial protection are particularly desired.

Figure 3 shows an embodiment of the assembly in which the closure body 28 forms part of the compartment 29 or is connected to the compartment 29 by a connecting part 30 comprising elastic bands 31 secured to the closure body and the compartment . When the closure is removed from the container 32 in the upward direction indicated by arrow 33, the connecting portion follows the closure and thereby ruptures the compartment, the contents of which flow onto the surface of the insertable part of the catheter.

Figure 4 shows a top view of the assembly in an embodiment having a tubular/annular shape. The outer periphery of the closure body 34 surrounds a compartment 35 which surrounds a urinary catheter 36 .

Figure 5a shows an assembly in which the sealing is represented by sealing means 37 arranged between the threads 38 of the closure and the threads 39 of the container to seal the package. In Fig. 5b sealing means 37' are shown arranged to surround the cup-shaped top 4.

FIG. 6 shows an assembly in which the gasket 40 is disposed between the inner surface of the container forming the sleeve portion and the outer surface of the urinary catheter 42 . The gasket separates the package into a first storage space 43 and a second storage space 44, preventing liquid from passing between them. The insertable part of the urinary catheter is arranged in the second storage space, and the connector is arranged in the first storage space.

Figure 7 shows an enlarged view of one embodiment of an assembly with a gasket. The compartment includes an elongated channel 45 . An elongated channel 45 extends between the first and second spaces such that the compartment can be accommodated in the first space and an outlet 46 releases liquid into the second space. The compartment 47 is made of a flexible material and when the closure 48 is pushed down towards the compartment the internal pressure of the liquid increases to the point where the seal 49 is severed and the liquid drains into the second space.

Figure 8 illustrates the use of a removable closure portion or top 14 for contamination-free insertion of a urinary catheter. The top is made of a soft elastic material which can be squeezed into contact with the catheter 5 after being released from the container to isolate the outer surface of the catheter from the user's hand.

FIG. 9 is an alternative embodiment of the invention in which the container comprises a first part 50 and a second part 51 connected by a piston seal 52 in the form of an expansion joint. The second part comprises a compartment 53 containing a fluid medium and a cavity 54 containing a medical instrument. The fluid medium is separated from the medical device by a wall 55 . A piston seal is attached to or forms part of the first portion and engages the inner surface of the second portion. During opening, the first part is pushed into the second part, or more particularly, the first part is pushed into the compartment. During the movement of the first part relative to the second part, the top foil 56 is released, thereby pushing the catheter 57 or similar medical device out of the package, and the fluid pressure in the compartment increases until a part 58 of the wall 55 ruptures. . At this point, the fluid medium represented by the gas bubbles is pushed from the compartment into the cavity containing the medical device so that the fluid and the medical device come into contact. To enable rupture of the wall 55, the wall may include weak points such as notches or cuts or similar features, whereby the strength of the wall is locally reduced. As an alternative to rupturing the wall, the wall may comprise an opening sealed with a closure, such as a strip of elastic or the like. When the first part moves relative to the second part, the closing body moves away from the opening under the effect of the increased pressure of the fluid medium. A protrusion 59 is provided to facilitate gripping the package by hand.

Claims (21)

1. assembly with the moistening medical apparatus and instruments of fluid media (medium), described assembly comprises the packing of holding described fluid media (medium), described assembly also comprises and holds fluid media (medium) so that at least one compartment that described fluid media (medium) does not contact with described medical apparatus and instruments, it is characterized in that, thereby described assembly comprises the device for opening that is applicable to that the combination opening action all is opened described packing and compartment.

2. assembly as claimed in claim 1, wherein, described device for opening is suitable for opening described packing and compartment by relative second component movement of first parts that makes described assembly.

3. assembly as claimed in claim 2, wherein, parts in these parts push in the process of relative second component movement of described first parts or destroy described compartment, thereby described compartment is opened.

4. as the described assembly of claim 2 to 3, wherein, described first parts form the part of described compartment, or adhesively are connected with compartment, when the described relatively compartment of described first parts moves described compartment is broken.

5. assembly as claimed in claim 4, wherein, described compartment is fixed on the part of described packing, thereby destroys compartment at described first parts when the part of described packing moves.

6. as the described assembly of claim 1 to 5, wherein, described device for opening is suitable for preventing making under the situation of not opening described compartment earlier described medical apparatus and instruments to expose.

7. as each described assembly in the above-mentioned claim, wherein, described device for opening is suitable for opening at the latest described compartment when opening described packing.

8. as each described assembly in the above-mentioned claim, wherein, described packing comprises container and have the opening that medical apparatus and instruments is come out from described packing, described opening is sealed by dismountable obturator, wherein, described obturator and compartment interact, to open described compartment when the described relatively container of described obturator moves.

9. assembly as claimed in claim 8, wherein, described obturator and compartment interact, to open described compartment when described packing is removed obturator.

10. as each described assembly in the above-mentioned claim, comprise cutting edge, described cutting edge forms and pierce through described compartment when the described device for opening of operation.

11. as claim 8 and 10 described assemblies, wherein, described cutting edge forms the part of described obturator.

12. as claim 8 and the described assembly of 10-11, wherein, described cutting edge forms the part of described container.

13. as each described assembly in the above-mentioned claim, wherein, described fluid media (medium) comprises antibiotic substance.

14. as each described assembly in the above-mentioned claim, wherein, described packing is held described compartment.

15. as each described assembly in the above-mentioned claim, wherein, described packing is held the first fluid medium, described compartment holds second fluid media (medium), wherein, described first and second fluid media (medium)s interact, and to provide before use medical apparatus and instruments are wished the active substance handled.

16. as each described assembly in the above-mentioned claim, wherein, described packing is formed for holding at least the slender casing of the length inserted of medical apparatus and instruments.

17. as each described assembly in the above-mentioned claim, wherein, described medical apparatus and instruments comprises and is suitable for inserting the intravital insertable part of live body, wherein, described compartment comprises being provided with and is used for making fluid media (medium) to be discharged into outlet on the described insertable part.

18. as each described assembly in the above-mentioned claim, wherein, described medical apparatus and instruments is a catheter.

19. as each described assembly in the above-mentioned claim, wherein, described compartment is around described medical apparatus and instruments.

20. method with the moistening medical apparatus and instruments of fluid media (medium), described fluid media (medium) is contained at least one compartment, described method comprises described medical apparatus and instruments and compartment is placed in the packing, with the step that does not directly contact at described fluid media (medium) of storage period chien shih and medical apparatus and instruments, with open described compartment with same opening action and pack, thereby the step that fluid is contacted with medical apparatus and instruments.

21. a compartment that is used for assembly as claimed in claim 19, described compartment forms around conduit.

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