EP4301449A1

EP4301449A1 - Medicinal product, functional part for a medicinal product, and method for sterilizing and/or for producing sterilization stability in a medicinal product or functional part

Info

Publication number: EP4301449A1
Application number: EP22710535.0A
Authority: EP
Inventors: Liesa Gläß; Benjamin Widmer; Manuel Arnaldi
Original assignee: B Braun Melsungen AG
Current assignee: B Braun Melsungen AG
Priority date: 2021-03-03
Filing date: 2022-02-25
Publication date: 2024-01-10
Also published as: DE102021202061A1; WO2022184582A1; US20240149042A1

Abstract

The invention relates to a medicinal product having an elastically deformable functional part with an openable slot arrangement, wherein the slot arrangement widens or opens in the event of elastic deformation of the elastically deformable functional part, and closes again when the elastic deformation ceases, wherein slot wall surfaces of the slot arrangement have a separation means that has or consists of a solid. The invention also relates to an elastically deformable functional part for a medicinal product, and to a method for sterilizing and/or producing sterilization stability in a medicinal product or in an elastically deformable functional part.

Description

Medical product, functional part for a medical product and method for sterilizing and/or making a medical product or functional part resistant to sterilization

FIELD OF APPLICATION AND PRIOR ART

The invention relates to a medical product that has an elastically deformable functional part with an openable slit arrangement, a corresponding functional part for a medical product, and a method for sterilizing and/or producing

Resistance to sterilization of such a medical product or functional part.

Gamma irradiation is a common sterilization method for medical products. If the medical products have a radiation-crosslinkable material, such as silicone elastomers, these materials also react when exposed to high-energy radiation

crosslinking reactions. In the case of slit valves, this can lead to undesired clogging of the slits, also referred to as healing.

In order to prevent such healing of slits, additives are usually added. The disadvantage is that such an additization usually leads to opaque materials. However, for many applications, for example connecting devices in the field of medical infusion therapy, it is absolutely necessary for individual functional parts, such as valve bodies, to remain transparent for the intended use. Another problem is that the addition of solid additives can bring about fundamental changes in material properties.

In addition to solid additives, liquid additives are also used. However, these must have sufficient wettability and, in particular, position stability in order to be able to perform their function. Radiation sterilization, aging processes and transport processes usually involve increased temperatures, which means that the separating effect of liquid separating agents often proves to be insufficient over time. In addition, some liquid release agents, such as silicone oils, also react to radiation sterilization, which can further reduce the release effect.

TASK AND SOLUTION

The present invention is therefore based on the object of providing a medical product and a functional part for a medical product which, in connection with generic medical products or functional parts, has known disadvantages, in particular clogging of slits and/or loss of transparency is partially or completely prevented. The invention is also based on the object of providing a method for sterilizing and/or making a medical product or functional part for a medical product sterilization-resistant, which partially or completely avoids the disadvantages mentioned at the outset.

This object is achieved by a medical product according to independent claim 1, by a functional part according to claim 14 and by a method according to claim 15. Preferred developments of the invention are defined in the dependent claims and in the description. The wording of all claims is hereby made part of the content of the present description by express reference.

According to a first aspect, the invention relates to a medical product.

The medical product has an elastically deformable functional part with an openable slit arrangement, with the slit arrangement widening, opening or folding up when the elastically deformable functional part undergoes elastic deformation and closing again when the elastic deformation ceases. Preferably, the slit arrangement widens during the elastic deformation of the elastically deformable functional part or the slit arrangement opens during the elastic deformation of the elastically deformable functional part in such a way that a fluid, in particular a liquid, preferably a medical solution, or a gas can flow through releases through the elastically deformable functional part. An elastic deformation of the elastically deformable functional part can take place, for example, when the medical product is connected to an infusion syringe, a hose or hose system or the like, in particular a medical infusion system.

The medical product is particularly characterized in that the slit wall surfaces of the slit arrangement have or are provided with a separating agent that has a solid, preferably a biocompatible solid, or consists of a solid, preferably a biocompatible solid. The slit wall surfaces, in particular only the slit wall surfaces, of the slit arrangement are preferably at least partially, in particular only partially or completely, i.e. over the entire surface or continuously, coated with the separating agent.

In a closed position of the slot arrangement, the slot wall surfaces are preferably at least partially, in particular only partially or, which is preferred, arranged or positioned continuously, in particular along a fluid passage axis, in particular central longitudinal axis, of the elastically deformable molded part. In an open position of the slit arrangement, the slit wall surfaces or slit walls are preferably pressed apart, for example by an infusion syringe, a tube or a tube system or the like, in particular of a medical infusion system.

In the context of the present invention, the term “functional part” should be understood to mean a component or a component or a component element of the medical product.

For the purposes of the present invention, the expression “slot wall surfaces” is to be understood as meaning surfaces or surfaces of walls which form or define a slot or are involved in the formation of a slot.

For the purposes of the present invention, the expression “release agent” should be understood to mean a substance which is able to reduce or (completely) avoid clogging, in particular radiation-induced clogging, of slots.

The term “biocompatible solid” is to be understood in the context of the present invention as a solid that can be used in the medical field, in particular in medical fields with direct or indirect patient contact, without any health concerns or risks.

The invention is based on the surprising finding that solids, preferably biocompatible solids, are suitable as separating agents to prevent healing phenomena, ie slits from becoming overgrown, in elastically deformable functional parts and medical products that have such functional parts. When exposed to radiation, in particular gamma radiation, beta radiation, X-ray radiation or electron beam radiation (e-beam radiation), better protection against radiation-induced crosslinking phenomena can thus be achieved. It is particularly advantageous that the invention enables radiation sterilization, in particular gamma radiation sterilization, to be carried out with a radiation dose of at least 32 kGy without (significant) clogging of slits. It is also advantageous that the invention makes it possible to increase the resistance to aging. The release agent is preferably liquid-free, ie free of liquids. As a result, the disadvantages described in the introduction in connection with liquid additives can be avoided.

In an embodiment of the invention, the functional part is transparent, i.e. translucent, at least in sections, in particular only in sections or completely. In the context of the present invention, the expression “transparent” or “translucent” should be understood to mean the ability of matter to let through electromagnetic waves with a wavelength of 380 nm to 780 nm (transmission). In this respect, the invention is based on the further surprising finding that the release agent additization provided according to the invention does not lead to an opaque change in the functional part in the case of a transparent functional part. Rather, the transparency of the elastically deformable functional part is advantageously retained.

In a further embodiment of the invention, the elastically deformable functional part has an elastically deformable material, in particular a transparent, i.e. translucent, elastically deformable material, or the elastically deformable functional part is, in particular in one piece, made of an elastically deformable material, in particular transparent, i.e. translucent, elastic deformable material.

The elastically deformable material is preferably an elastomer and/or thermoplastic elastomer.

The elastomer can in particular be selected from the group consisting of silicone elastomers such as silicone rubber, acrylonitrile butadiene rubber, hydrogenated acrylonitrile butadiene rubber and mixtures of at least two of the aforementioned elastomers. Alternatively or in combination, the elastomer may be another polymer that is capable of crosslinking or in which crosslinking reactions predominate.

In a further embodiment of the invention, the slit wall surfaces, in particular only the slit wall surfaces, of the slit arrangement are at least partially, in particular only partially or completely, ie continuously or over the entire surface, coated with the release agent, in particular powdered or wetted. The elastically deformable functional part is preferably free of the separating agent, apart from the slot wall surfaces of the slot arrangement. In particular, the separating agent is not present within the elastically deformable functional part, in particular in a dispersed or distributed manner. Instead, the release agent is preferably located exclusively on the slot wall surfaces slot arrangement. As a result, the risk of material properties, such as in particular transparency and/or mechanical properties, of the functional part changing can advantageously be additionally reduced.

In a further embodiment of the invention, the solid is in the form of a powder. As a result, the separating agent, for example by means of compressed air, can be applied or introduced onto the slot wall surfaces or between the slot wall surfaces of the slot arrangement without any complications. This in turn contributes to an optimal release effect of the release agent.

In a further embodiment of the invention, the solid, in particular the powder, has a grain size or an average particle diameter of <(read: smaller) 400 μm, in particular 1 μm to 50 μm, preferably 0.1 μm to 10 μm. As a result, an application can be additionally optimized.

In a further embodiment of the invention, the solid is a salt. In particular, the solid, in particular salt, can be an alkali metal salt, in particular selected from the group consisting of alkali metal chloride, alkali metal bromide, alkali metal iodide and mixtures of at least two of the aforementioned alkali metal salts.

The alkali metal chloride can in particular be selected from the group consisting of lithium chloride, sodium chloride, potassium chloride and mixtures of at least two of the aforementioned alkali metal chlorides.

The alkali metal bromide can in particular be selected from the group consisting of lithium bromide, sodium bromide, potassium bromide and mixtures of at least two of the aforementioned alkali metal bromides.

The alkali metal iodide can in particular be selected from the group consisting of lithium iodide, sodium iodide, potassium iodide and mixtures of at least two of the aforementioned alkali metal iodides.

The solid is particularly preferably sodium chloride.

When using the aforementioned salts, in particular sodium chloride, the advantages according to the invention can be realized particularly well. In a further embodiment of the invention, the solid is a saccharide. In principle, the saccharide can be a monosaccharide, oligosaccharide, such as a disaccharide, or polysaccharide, or a mixture of at least two of the aforementioned saccharides.

The solid, in particular the saccharide, is preferably glucose.

When using a saccharide, in particular glucose, the advantages according to the invention are (also) very pronounced.

In a further embodiment of the invention, the solid is a vitamin, in particular ascorbic acid, preferably L-(+)-ascorbic acid, i.e. vitamin C. The advantages according to the invention are (also) when using ascorbic acid, preferably L-(+)-ascorbic acid or vitamin C, particularly easy to implement.

It can further be preferred that the solid is present in the form of a mixture. The mixture preferably has at least two substances or consists of at least two substances selected from the group consisting of salts, saccharides, vitamins and mixtures of at least two of the aforementioned substances. The mixture can particularly preferably have at least two substances or consist of at least two substances which are selected from the group consisting of sodium chloride, glucose and L-(+)-ascorbic acid (vitamin C). Accordingly, the mixture can contain, for example, sodium chloride and glucose or consist of sodium chloride and glucose. Alternatively, the mixture may include, for example, sodium chloride and L-(+)-ascorbic acid or consist of sodium chloride and L-(+)-ascorbic acid. Alternatively, the mixture can, for example, contain glucose and L-(+)-ascorbic acid or consist of glucose and L-(+)-ascorbic acid. Alternatively, the mixture may include, for example, sodium chloride, glucose and L-(+)-ascorbic acid or consist of sodium chloride, glucose and L-(+)-ascorbic acid.

Furthermore, the separating agent can contain a liquid in addition to the solid. This can advantageously improve the wettability of the slot wall surfaces of the slot arrangement and also the adhesion of the separating agent to the slot wall surfaces of the slot arrangement. In particular, the solid can be wetted with a corresponding liquid for this purpose. For example, the liquid may be an oil or a mixture of oils. In a further embodiment of the invention, the slot arrangement is designed as a longitudinal slot arrangement, ie a linear slot arrangement.

Alternatively, the slot arrangement can be designed differently, for example in the shape of a cross, i.e. as a so-called cross slot arrangement.

In a further embodiment of the invention, the elastically deformable functional part is designed as a valve body.

In a further embodiment of the invention, the elastically deformable functional part, in particular the valve body, has a head area, in particular a cover-shaped head area. The slot arrangement is preferably formed along a transverse extent, i.e. transverse to a longitudinal extent, of the head portion. The slot arrangement particularly preferably extends, in particular centrally, along a longitudinal axis or fluid passage axis, in particular central longitudinal axis, through the head region. A jacket of the elastically deformable functional part preferably adjoins the head area, in particular directly. If the elastically deformable functional part is designed as a valve body, which is preferred according to the invention, a valve jacket is attached to the head area, in particular directly. The valve jacket preferably has a radial cross section, which preferably has a greater longitudinal extent than transverse extent. The radial cross section of the valve jacket is related to a longitudinal axis or fluid passage axis of the valve body, which preferably corresponds to a central longitudinal axis of the valve body. The head area and/or jacket, for example only the head area or only the jacket, of the elastically deformable functional part, in particular the valve body, can be made transparent, i.e. a transparent, elastically deformable material, preferably an elastomer, in particular silicone elastomer, and/or thermoplastic Elastomer, have or be made of such a material. With regard to other suitable materials, reference is made to the preceding description.

The elastically deformable functional part is preferably used for a connecting device of a medical infusion system. A corresponding connecting device is known, for example, from EP 3 216 486 A1. The features and advantages described there in relation to the connection device are made part of the content of the present description by express reference.

In a further embodiment of the invention, the medical product is a medical product for infusion therapy. This is particularly preferred Medical product around a connecting device, in particular a medical infusion system. The medical product, in particular the connecting device, can be designed, for example, as a one-way stopcock, two-way stopcock, three-way stopcock, four-way stopcock or as a stopcock bank, ie as a unit or a system with or made up of one-way stopcocks arranged or connected in series. The medical product, in particular the connecting device, is preferably designed as a two-way stopcock, three-way stopcock, four-way stopcock or as a stopcock bank.

The medical product is preferably present in sterilized form, in particular sterilized by radiation, preferably sterilized by gamma rays, sterilized by beta radiation, sterilized by X-rays or sterilized by electron beams. The medical product is preferably exposed to radiation, preferably gamma radiation, beta radiation, X-ray radiation or electron beam radiation (e-beam radiation), in particular with a radiation dose of at least 32 kGy, in particular 32 kGy to 100 kGy, in particular 32 kGy to 45kGy, sterilized.

Alternatively, the medical device can be in non-sterilized form.

According to a second aspect, the invention relates to an elastically deformable functional part for a medical product.

The elastically deformable functional part has an openable slot arrangement which widens, opens or unfolds when the elastically deformable functional part undergoes elastic deformation and closes again when the elastic deformation ceases. Slit wall surfaces of the slit arrangement have a separating agent which has a solid, preferably a biocompatible solid, or consists of a solid, preferably a biocompatible solid.

With regard to further features and advantages of the elastically deformable functional part, in particular the slot arrangement and the separating means, as well as the medical product, reference is made in full to the corresponding statements made under the first aspect of the invention. The features and advantages described there also apply analogously to the elastically deformable functional part according to the second aspect of the invention.

According to a third aspect, the invention relates to a method for sterilizing and/or making a medical product resistant to sterilization according to the first Aspect of the invention or an elastically deformable functional part according to the second aspect of the invention. The method has the following steps in chronological order: a) Coating or impingement, in particular powdering or wetting, of the slot wall surfaces of the slot arrangement with the separating agent, which has a solid, preferably a biocompatible solid, or consists of a solid, preferably a biocompatible solid, and b) Sterilizing the medical product or elastically deformable functional part, in particular by exposure to radiation, preferably gamma radiation, X-ray radiation, beta radiation or electron beam radiation (e-beam radiation).

The method according to the third aspect of the invention is thus characterized in that step b) is carried out after step a).

The slot wall surfaces of the slot arrangement can be coated or applied, in particular powdered or wetted, with the release agent only partially or completely, i.e. continuously or over the entire surface.

Furthermore, step a) can be carried out by means of compressed air, which conveys the separating agent to the slot wall surfaces of the slot arrangement. Step a) can be carried out under an air pressure of 0.1 bar to 7 bar, preferably 0.5 bar to 3 bar. Furthermore, step a) can be carried out with an air volume flow time of 1 ms (0.001 s) to 5 s, preferably 50 ms (0.05 s) to 1 s.

A salt, in particular an alkali metal salt, preferably an alkali metal chloride, particularly preferably sodium chloride, is preferably used as the solid. With regard to other possible salts, reference is made to the corresponding salts disclosed under the first aspect of the invention. The salts additionally described there can also be used in the process according to the invention.

Alternatively, a saccharide, in particular monosaccharide, oligosaccharide (such as disaccharide) or polysaccharide, is preferably used as the solid. Glucose is particularly preferably used as the biocompatible solid.

Alternatively, a vitamin, in particular ascorbic acid, particularly preferably L-(+)-ascorbic acid (vitamin C), is preferably used as the solid. Furthermore, step b) can be carried out with a radiation dose of at least 32 kGy, in particular 32 kGy to 100 kGy, in particular 32 kGy to 45 kGy.

With regard to further features and advantages of the method, reference is made in full to the corresponding statements made under the first and second aspects of the invention. The features and advantages described there, in particular with regard to the elastically deformable functional part and the medical product, also apply analogously to the method according to the third aspect of the invention.

Further features and advantages of the invention result from the following description of preferred embodiments with reference to figures, descriptions of figures and dependent claims. Individual features of the invention can be implemented individually or in combination with one another. The preferred embodiments are merely illustrative of the invention, which is in no way intended to be limited thereto.

FIGURE SHORT DESCRIPTIONS

1 shows a plan view of an embodiment of a medical product according to the invention in the form of a connecting device,

FIG. 2 shows a section through the medical product according to FIG. 1 along the section line II-II in FIG. 1,

3 shows a view from below of a functional part of the medical product according to FIG. 2 designed as a valve body,

4 shows a longitudinal section through the valve body according to FIG. 3 along the section line IV-IV in FIG. 3,

Fig. 5 shows a further longitudinal section through the valve body along section line V-V in Fig. 3,

6 shows a plan view of the valve body according to FIGS. 3 to 5,

7 to 9 in sectional representations different steps when connecting a component to the medical product according to FIG 10a, b show an embodiment of a method according to the invention.

DETAILED CHARACTER DESCRIPTIONS

1 schematically shows an embodiment of a medical product according to the invention in the form of a connecting device 1 of a medical infusion system. The connecting device 1 can, for example, be designed as a three-way valve, as shown in FIG. It goes without saying, however, that the connecting device 1 can deviate from this, in particular as a one-way or two-way valve or as a bank of valves, i.e. as a unit or a system with or from one-way valves connected in series, i.e. one behind the other.

The connecting device 1 has a housing 2 , a connecting piece 3 and two connecting areas 4 , 5 . In the housing 2, an actuator 6 is rotatably mounted. A total of three connecting channels are also provided in the housing 2, which are blocked or connected to one another depending on the position of the actuator 6. A connecting channel of the housing 2 leads to the connecting piece 3. Another connecting channel arranged at right angles leads to the connecting area 4 and opposite thereto a third connecting channel leads to the connecting area 5. One of the two connecting areas 4, 5 is provided for the connection of a patient line. The other connection area 4, 5 is used to connect a connecting line to a fluid container.

The connecting piece 3 is preferably provided for temporarily connecting a component of the medical infusion system, such as a syringe in particular, in order to supply (additional) medication or the like to the patient line, for example. Additionally or alternatively, the connecting piece 3 can be provided for a connection, in particular a permanent connection (permanent connection), of an additional line.

The connecting piece 3 is explained in more detail with reference to the following FIGS. 3 to 5.

The connecting piece 3 can have a dimensionally stable cap 8 which is connected, preferably firmly, to a dimensionally stable bottom section 7 of the housing 2 on its end face facing the housing 2 . The cap 8 is sleeve-shaped and has a thickened edge region on the side facing the base section 7, which is firmly connected to the base section 7, for example by welding. The bottom section 7 is plate-shaped and protrudes relative to a central longitudinal axis L of the connecting piece 3 radially outwards. The bottom section 7 surrounds a channel section that tapers conically toward an interior of the housing 2 .

The cap 8 is provided with a passage 10 in its end region remote from the base section 7, which passage can be closed by a valve body 11 of the connecting device 1, which is described in more detail below. The passage 10 is surrounded by a thickened edge area which is provided with connection profiles 9 in the form of Luer lock profiles.

The valve body 11 is preferably designed in the manner of a cup or bell and is in particular made in one piece from an elastically deformable material. The elastically deformable material is preferably an elastomer or thermoplastic elastomer. The elastically deformable material is particularly preferably a silicone elastomer, such as silicone rubber. In addition, the elastically deformable material is preferably transparent, i.e. translucent.

The valve body 11 preferably has an outer contour which, in an unloaded, i.e. undeformed, initial state, lies flush and flat against the inner contour of the cap 8 over the entire height of the cap 8 . The valve body 11 has a head area, in particular a cover-shaped head area 12 . The head area 12 can have a rotationally symmetrical, in particular circular, or, as shown, a rotationally asymmetrical, in particular oval, base area (see in particular FIGS. 3 and 6). The valve body 11 also has a valve casing 15 . The valve jacket 15 adjoins the head area 12, preferably directly. The valve jacket 15 is preferably provided with a bottom ring 16 on a lower front end area. The head portion 12 is provided with a slot arrangement 14 . A surface 13 of the head area 12 is preferably smooth and flat.

It can be seen from FIG. 7 that the surface 13 of the head area 12 can terminate flush with a peripheral edge of the passage 10 in an unloaded initial state of the valve body 11 in the cap 8 . From this edge of the passage 10, an oblique chamfer extends outwards to an end face of the edge area of the cap 8 that defines the passage 10. In the unloaded initial state of the valve body 11, the end face of the edge area of the cap 8, including the surface 13 of the head area 12 of the valve body 11 can be cleaned and disinfected by medical personnel in a simple manner, for example using a disinfectant wipe or the like. The valve jacket 15 of the valve body 11 is preferably designed to be rotationally symmetrical relative to the central longitudinal axis L. The valve jacket 15 preferably has a wall that thickens from the head area 12 to the bottom area 16 . The thickening can be discontinuous and not linear, as can be seen from the two visible edges shown. The edges are preferably annular. In this case, the valve casing 15 can have a first wall section of constant thickness which adjoins the head region 12 and widens in the manner of a truncated cone. A second wall section can adjoin this first wall section in the direction of the base ring 16 , the inner wall of which runs cylindrically and coaxially to the central longitudinal axis L and the outer wall of which runs further outwardly curved towards the base ring 16 . A wall section on the bottom side can adjoin this, in particular middle, wall section. The bottom wall section preferably includes the bottom ring 16. In this area, the inner wall preferably tapers from the cylindrical central area to the bottom section, resulting in an inner wall section that tapers conically downwards.

Toward the end face of the bottom ring 16 , the inner wall can again expand conically, forming a contact area 18 . Accordingly, an egg-shaped or O-shaped inner contour 17 can result over the height of the valve jacket 15 (see FIGS. 4 and 5).

An inner surface of the head region 12 pointing into the interior of the valve jacket 15 can, as shown in FIG. 5, be designed as a dome-like contour 19.

The passage 10 of the cap 8 can be rotationally symmetrical or rotationally asymmetrical. In the case of a rotationally asymmetrical head region 12, the passage 10 is preferably also designed to be rotationally asymmetrical in a complementary manner.

As can be seen from FIGS. 2 and 7 to 9, the conical contact surface 18 of the base ring 16 of the valve body 11 in the area of the base section 7 is assigned a complementary conical support surface 20, whereby the valve body 11 in the area of the base ring 16 extends over its entire radial Width flat on the bottom section 7 is supported.

The slot arrangement 14 is aligned transversely to a longitudinal extent of the head region 12, as can be seen from FIGS. 4 to 6. The slot arrangement 14 preferably extends centrally along the central longitudinal axis L through the head region 12 . The slot arrangement 14 has two slot wall surfaces 21, 22 which close the slot arrangement 14 in an unloaded initial state of the valve body 11, preferably tightly. The slit wall surfaces 21, 22 of the slit arrangement 14 are provided with a separating agent 23. The slit wall surfaces 21, 22 can be provided, in particular coated, with the separating agent 23 only partially or completely, ie over the entire surface.

The separating agent 23 is preferably located only on the slot wall surfaces 21, 22 of the slot arrangement 14. In other words, the rest of the head region 12 and the valve jacket 15 are preferably free of a separating agent, i.e. free of the separating agent

The separating means 23 can advantageously prevent radiation-induced crosslinking of the elastically deformable material of the valve body 11, for example during gamma sterilization, beta sterilization, X-ray sterilization or electron beam sterilization (e-beam sterilization) of the connecting device 1. As a result, the risk of the slot arrangement 14 becoming overgrown can be significantly reduced or even completely avoided.

The separating means 23 has a solid, preferably a biocompatible solid, or consists of a solid, preferably a biocompatible solid. The solid is preferably a salt, particularly preferably sodium chloride.

Alternatively or in combination, the solid may preferably be a saccharide, most preferably glucose.

Alternatively or in combination, the solid can be a vitamin, particularly preferably vitamin C.

The aforementioned substances have proven to be particularly suitable with regard to preventing the slit arrangement 14 from growing or healing during radiation sterilization, such as in particular gamma radiation sterilization. A further advantage of these substances consists in particular in the fact that they do not impair any transparency of the valve body 11 . In addition, the aforementioned substances can advantageously contribute to an increase in the aging resistance of the valve body 11 .

As soon as a tip of a component K to be attached to the connection piece 3 is brought up to the connection piece 3 from the outside, the tip comes into planar contact with the outer surface of the head area 12 and presses the head area 12 into the interior of the cap 8 . The slit arrangement 14 widens, and elastically deformed sections of the head area 12 lie down as the tip of the component K penetrates further outside to the top. When the tip is disconnected and the tip is removed outwards as a result, the head area 12 returns to the starting position according to FIG. 7 .

FIGS. 10a and b schematically show an embodiment of a method according to the invention.

In the method, the slot wall surfaces 21, 22 of the slot arrangement 14 are first coated with a powdery solid as a release agent. For this purpose, a valve body 11 is placed in a receptacle or directly on a nozzle 24 . In this case, the nozzle 24 can be approached with a hold-down device and/or a compression pad until the valve body 11 is compressed. Furthermore, as shown in Figs. 10a and b, the valve body 11 can be pressed against a luer-like or cylindrical component 25, causing the valve body 11 to open at least partially. In this way, the component 25 can retract somewhat, as shown in FIG. 10b.

The powdered solid is preferably applied by an air flow that is conducted through the partially or fully open valve body 11 in such a way that the air flow floods the slot wall surfaces 21 , 22 of the slot arrangement 14 with the powdery solid. The transport of the powdery solid by the air stream takes place in the direction of the arrow (see FIG. 10b).

The air pressure for conveying the powdered solid to the slot wall surfaces 21, 22 of the slot arrangement 14 can be selected from 0.1 bar to 7 bar, preferably 0.5 bar to 3 bar. Furthermore, a volume flow time of 1 ms to 5 s, in particular 50 ms to 1 s, can be selected.

The valve body 11 is preferably compressed and therefore opened in such a way that the inner lumen of the valve body 11 is not powdered.

Claims

patent claims

1. Medical product comprising an elastically deformable functional part with an openable slit arrangement, the slit arrangement widening or opening when the elastically deformable functional part undergoes elastic deformation and closing again when the elastic deformation ceases, characterized in that the slit wall surfaces of the slit arrangement have a separating agent, comprising or consisting of a solid, wherein the slot wall surfaces of the slot arrangement are at least partially, in particular only partially or completely, coated with the release agent.

2. Medical product according to claim 1, characterized in that the elastically deformable functional part is designed to be transparent, i.e. translucent, at least in sections.

3. Medical product according to claim 1 or 2, characterized in that the elastically deformable functional part is made of a silicone elastomer and/or thermoplastic elastomer.

4. Medical product according to one of the preceding claims, characterized in that only the slot wall surfaces of the slot arrangement are at least partially, in particular only partially or completely, coated with the separating agent.

5. Medical product according to one of the preceding claims, characterized in that the solid is in the form of a powder.

6. Medical product according to one of the preceding claims, characterized in that the solid has a grain size of <400 μm, in particular 1 μm to 50 μm, preferably 0.1 μm to 10 μm.

7. Medical product according to one of the preceding claims, characterized in that the solid is a salt, in particular an alkali metal salt, preferably sodium chloride.

8. Medical product according to one of claims 1 to 6, characterized in that the solid is a saccharide, in particular a monosaccharide, preferably glucose.

9. Medical product according to one of claims 1 to 6, characterized in that the solid is a vitamin, in particular L-(+)-ascorbic acid.

10. Medical product according to one of the preceding claims, characterized in that the slot arrangement is designed as a longitudinal slot arrangement.

11. Medical product according to one of the preceding claims, characterized in that the elastically deformable functional part is designed as a valve body.

12. Medical product according to one of the preceding claims, characterized in that the elastically deformable functional part has a head area, the slot arrangement being formed along a transverse extent of the head area and extending centrally through the head area along a central longitudinal axis.

13. Medical product according to one of the preceding claims, characterized in that the medical product is a medical product for infusion therapy, in particular a connecting device, in particular in the form of a one-way, two-way, three-way or four-way tap or a tap bank, a medical infusion system.

14. An elastically deformable functional part for a medical product, characterized in that the elastically deformable functional part is designed according to at least one of the preceding claims.

15. Method for producing sterilization resistance of a medical product according to one of claims 1 to 13 or of an elastically deformable functional part according to claim 14, characterized in that the method has the following steps in chronological order: a) coating or impinging on the slit wall surfaces of the slit arrangement with the separating agent comprising or consisting of a solid, and b) sterilizing the medical product or elastically deformable functional part, preferably by exposure to gamma, X-ray, beta or electron beam radiation.