EP4301449A1 - Produit médicinal, partie fonctionnelle pour un produit médicinal et procédé de stérilisation et/ou de production d'une stabilité de stérilisation dans un produit médicinal ou une partie fonctionnelle - Google Patents

Produit médicinal, partie fonctionnelle pour un produit médicinal et procédé de stérilisation et/ou de production d'une stabilité de stérilisation dans un produit médicinal ou une partie fonctionnelle

Info

Publication number
EP4301449A1
EP4301449A1 EP22710535.0A EP22710535A EP4301449A1 EP 4301449 A1 EP4301449 A1 EP 4301449A1 EP 22710535 A EP22710535 A EP 22710535A EP 4301449 A1 EP4301449 A1 EP 4301449A1
Authority
EP
European Patent Office
Prior art keywords
medical product
functional part
elastically deformable
solid
product according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22710535.0A
Other languages
German (de)
English (en)
Inventor
Liesa Gläß
Benjamin Widmer
Manuel Arnaldi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
B Braun Melsungen AG
Original Assignee
B Braun Melsungen AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by B Braun Melsungen AG filed Critical B Braun Melsungen AG
Publication of EP4301449A1 publication Critical patent/EP4301449A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J3/00—Processes of treating or compounding macromolecular substances
    • C08J3/28—Treatment by wave energy or particle radiation
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J7/00—Chemical treatment or coating of shaped articles made of macromolecular substances
    • C08J7/04—Coating
    • C08J7/06—Coating with compositions not containing macromolecular substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1061—Break-apart tubing connectors or couplings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/24—Check- or non-return valves
    • A61M2039/2426—Slit valve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22—Valves or arrangement of valves
    • A61M39/26—Valves closing automatically on disconnecting the line and opening on reconnection thereof
    • A61M2039/263—Valves closing automatically on disconnecting the line and opening on reconnection thereof where the fluid space within the valve is decreasing upon disconnection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2207/00—Methods of manufacture, assembly or production
    • A61M2207/10—Device therefor
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2300/00—Characterised by the use of unspecified polymers
    • C08J2300/26—Elastomers
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
    • C08J2383/00—Characterised by the use of macromolecular compounds obtained by reactions forming in the main chain of the macromolecule a linkage containing silicon with or without sulfur, nitrogen, oxygen, or carbon only; Derivatives of such polymers
    • C08J2383/04—Polysiloxanes

Definitions

  • 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
  • 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
  • additives are usually added.
  • the disadvantage is that such an additization usually leads to opaque materials.
  • individual functional parts such as valve bodies, 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the term “functional part” should be understood to mean a component or a component or a component element of the medical product.
  • 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.
  • 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.
  • 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.
  • radiation in particular gamma radiation, beta radiation, X-ray radiation or electron beam radiation (e-beam radiation)
  • 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.
  • 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.
  • the functional part is transparent, i.e. translucent, at least in sections, in particular only in sections or completely.
  • 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).
  • 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.
  • 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.
  • the elastomer may be another polymer that is capable of crosslinking or in which crosslinking reactions predominate.
  • 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.
  • the separating agent is not present within the elastically deformable functional part, in particular in a dispersed or distributed manner.
  • the release agent is preferably located exclusively on the slot wall surfaces slot arrangement.
  • the solid is in the form of a powder.
  • 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.
  • the solid, in particular the powder has a grain size or an average particle diameter of ⁇ (read: smaller) 400 ⁇ m, in particular 1 ⁇ m to 50 ⁇ m, preferably 0.1 ⁇ m to 10 ⁇ m.
  • ⁇ (read: smaller) 400 ⁇ m in particular 1 ⁇ m to 50 ⁇ m, preferably 0.1 ⁇ m to 10 ⁇ m.
  • the solid is a salt.
  • 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.
  • the solid is a saccharide.
  • 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.
  • the solid is a vitamin, in particular ascorbic acid, preferably L-(+)-ascorbic acid, i.e. vitamin C.
  • ascorbic acid preferably L-(+)-ascorbic acid
  • vitamin C particularly easy to implement.
  • 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).
  • the mixture can contain, for example, sodium chloride and glucose or consist of sodium chloride and glucose.
  • the mixture may include, for example, sodium chloride and L-(+)-ascorbic acid or consist of sodium chloride and L-(+)-ascorbic acid.
  • the mixture can, for example, contain glucose and L-(+)-ascorbic acid or consist of glucose and L-(+)-ascorbic acid.
  • the mixture may include, for example, sodium chloride, glucose and L-(+)-ascorbic acid or consist of sodium chloride, glucose and L-(+)-ascorbic acid.
  • 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.
  • the solid can be wetted with a corresponding liquid for this purpose.
  • the liquid may be an oil or a mixture of oils.
  • the slot arrangement is designed as a longitudinal slot arrangement, ie a linear slot arrangement.
  • the slot arrangement can be designed differently, for example in the shape of a cross, i.e. as a so-called cross slot arrangement.
  • the elastically deformable functional part is designed as a valve body.
  • 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.
  • 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.
  • the medical device can be in non-sterilized form.
  • 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.
  • 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).
  • radiation preferably gamma radiation, X-ray radiation, beta radiation or electron beam radiation (e-beam radiation).
  • step b) is carried out after step a).
  • 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.
  • 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.
  • 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.
  • an alkali metal salt preferably an alkali metal chloride, particularly preferably sodium chloride
  • the salts additionally described there can also be used in the process according to the invention.
  • 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.
  • 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.
  • FIG. 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,
  • FIG. 3 shows a view from below of a functional part of the medical product according to FIG. 2 designed as a valve body
  • FIG. 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,
  • FIGS. 3 to 5 shows a plan view of the valve body according to FIGS. 3 to 5
  • FIG 10a, b show an embodiment of a method according to the invention.
  • the connecting device 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 .
  • an actuator 6 is rotatably mounted 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.
  • 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.
  • 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 .
  • an oblique chamfer extends outwards to an end face of the edge area of the cap 8 that defines the passage 10.
  • 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.
  • 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.
  • the inner wall preferably tapers from the cylindrical central area to the bottom section, resulting in an inner wall section that tapers conically downwards.
  • 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.
  • the passage 10 is preferably also designed to be rotationally asymmetrical in a complementary manner.
  • 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.
  • the solid may preferably be a saccharide, most preferably glucose.
  • 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 .
  • the aforementioned substances can advantageously contribute to an increase in the aging resistance of the valve body 11 .
  • 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.
  • FIGS. 10a and b schematically show an embodiment of a method according to the invention.
  • the slot wall surfaces 21, 22 of the slot arrangement 14 are first coated with a powdery solid as a release agent.
  • a valve body 11 is placed in a receptacle or directly on a nozzle 24 .
  • the nozzle 24 can be approached with a hold-down device and/or a compression pad until the valve body 11 is compressed.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Polymers & Plastics (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un produit médicinal comportant une partie fonctionnelle élastiquement déformable pourvue d'un agencement de fentes pouvant être ouvert, l'agencement de fentes s'élargissant ou s'ouvrant en cas de déformation élastique de la partie fonctionnelle élastiquement déformable, et se fermant à nouveau lorsque la déformation élastique cesse, les surfaces de paroi de fente de l'agencement de fentes possédant un moyen de séparation qui contient un solide ou en est constitué. L'invention concerne également une partie fonctionnelle élastiquement déformable pour un produit médicinal, et un procédé de stérilisation et/ou de production d'une stabilité de stérilisation dans un produit médicinal ou dans une partie fonctionnelle élastiquement déformable
EP22710535.0A 2021-03-03 2022-02-25 Produit médicinal, partie fonctionnelle pour un produit médicinal et procédé de stérilisation et/ou de production d'une stabilité de stérilisation dans un produit médicinal ou une partie fonctionnelle Pending EP4301449A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102021202061.5A DE102021202061A1 (de) 2021-03-03 2021-03-03 Medizinprodukt, Funktionsteil für ein Medizinprodukt und Verfahren zum Sterilisieren und/oder zum Herstellen von Sterilisationsbeständigkeit eines Medizinprodukts oder Funktionsteils
PCT/EP2022/054802 WO2022184582A1 (fr) 2021-03-03 2022-02-25 Produit médicinal, partie fonctionnelle pour un produit médicinal et procédé de stérilisation et/ou de production d'une stabilité de stérilisation dans un produit médicinal ou une partie fonctionnelle

Publications (1)

Publication Number Publication Date
EP4301449A1 true EP4301449A1 (fr) 2024-01-10

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EP22710535.0A Pending EP4301449A1 (fr) 2021-03-03 2022-02-25 Produit médicinal, partie fonctionnelle pour un produit médicinal et procédé de stérilisation et/ou de production d'une stabilité de stérilisation dans un produit médicinal ou une partie fonctionnelle

Country Status (4)

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US (1) US20240149042A1 (fr)
EP (1) EP4301449A1 (fr)
DE (1) DE102021202061A1 (fr)
WO (1) WO2022184582A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102022207782A1 (de) 2022-07-28 2024-02-08 B. Braun Melsungen Aktiengesellschaft Medizinprodukt, Funktionsteil für ein Medizinprodukt und Verfahren zum Sterilisieren und/oder zum Herstellen von Sterilisationsbeständigkeit eines Medizinprodukts oder Funktionsteils

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1411850A1 (de) 1962-10-03 1968-10-31 Hans Lissner Herstellung von Ventilsaecken
DK1449585T3 (da) 1999-07-07 2007-11-05 3M Innovative Properties Co Mikrofluid artikel
KR20110129869A (ko) * 2009-01-23 2011-12-02 큐엘티 인코포레이티드 하나 이상의 제제의 서방형 전달
AT508099B1 (de) 2009-03-17 2015-07-15 Semperit Ag Holding Verfahren zur herstellung eines vernetzten elastomers
JP5770736B2 (ja) * 2010-09-17 2015-08-26 テルモ株式会社 シリコーンゴム組成物
EP2554214A1 (fr) * 2011-08-04 2013-02-06 B. Braun Melsungen AG Connecteur sans aiguille doté d'un raccord de membrane résilient démontable et procédé correspondant
AU2013243693B2 (en) * 2012-04-04 2016-10-20 The General Hospital Corporation Peroxide cross-linking of polymeric materials in the presence of antioxidants
AT513212B1 (de) 2012-07-05 2014-05-15 Semperit Ag Holding Verfahren zur Behandlung einer Oberfläche eines Elastomerprodukts
DE102016203518A1 (de) 2016-03-03 2017-09-07 B. Braun Melsungen Ag Verbindungseinrichtung eines medizinischen Infusionssystems
CN114173835B (zh) * 2019-06-14 2023-01-06 盖斯特里希医药公司 含有抗坏血酸的可注射式水性植入物制剂

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WO2022184582A1 (fr) 2022-09-09
US20240149042A1 (en) 2024-05-09

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