WO2022258646A1 - Verbindungssystem für medizinische anwendungen - Google Patents
Verbindungssystem für medizinische anwendungen Download PDFInfo
- Publication number
- WO2022258646A1 WO2022258646A1 PCT/EP2022/065464 EP2022065464W WO2022258646A1 WO 2022258646 A1 WO2022258646 A1 WO 2022258646A1 EP 2022065464 W EP2022065464 W EP 2022065464W WO 2022258646 A1 WO2022258646 A1 WO 2022258646A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- adhesive
- annular gap
- connector
- connection system
- capsule shell
- Prior art date
Links
- 230000001070 adhesive effect Effects 0.000 claims abstract description 127
- 239000000853 adhesive Substances 0.000 claims abstract description 126
- 230000004913 activation Effects 0.000 claims abstract description 25
- 230000000295 complement effect Effects 0.000 claims abstract description 12
- 239000002775 capsule Substances 0.000 claims description 76
- 238000005538 encapsulation Methods 0.000 claims description 7
- 239000000126 substance Substances 0.000 claims description 7
- 210000000697 sensory organ Anatomy 0.000 claims description 2
- 238000007654 immersion Methods 0.000 claims 1
- 230000037431 insertion Effects 0.000 abstract 1
- 238000003780 insertion Methods 0.000 abstract 1
- 239000011257 shell material Substances 0.000 description 41
- 239000000463 material Substances 0.000 description 10
- 239000007788 liquid Substances 0.000 description 6
- 230000006378 damage Effects 0.000 description 5
- 239000003205 fragrance Substances 0.000 description 5
- 239000002904 solvent Substances 0.000 description 5
- 230000009969 flowable effect Effects 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 235000011837 pasties Nutrition 0.000 description 3
- 230000036541 health Effects 0.000 description 2
- 239000010410 layer Substances 0.000 description 2
- 238000010008 shearing Methods 0.000 description 2
- 239000004831 Hot glue Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000037237 body shape Effects 0.000 description 1
- 230000009172 bursting Effects 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000000284 resting effect Effects 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
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
- A61M39/1011—Locking means for securing connection; Additional tamper safeties
-
- 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
- A61M2039/1094—Tube connectors; Tube couplings at least partly incompatible with standard connectors, e.g. to prevent fatal mistakes in connection
Definitions
- Luer lock connection system is generally known from medical technology. Luer lock connection systems are used to connect medical fluid systems or to connect medical syringes to catheters or other medical connection systems. Luer lock connection systems of this type are used for the detachable connection of corresponding medical functional sections. In some medical applications it is necessary to be able to no longer loosen a connection between two medical functional parts once it has been closed.
- the object of the invention is to create a connection system of the type mentioned at the outset, which enables reliable use in medical specialist areas in which there is a high health risk for patients and users.
- the activation system can be assigned directly or indirectly to the adhesive arrangement, as will be explained below.
- the indirect assignment is preferably to be understood as a mechanical encapsulation of the adhesive arrangement.
- a direct association is to be understood as meaning physical properties or chemical properties of the adhesive arrangement which only allow the adhesive arrangement to be activated under certain physical or chemical conditions.
- the adhesive arrangement can be made of one or more components. Corresponding adhesive components of the adhesive arrangement can be separated from one another in the inactive state. Appropriate adhesive components include not only components of a two-component adhesive, but also primers that are used to pretreat a material to be bonded, or fragrances that can be detected by a user when they are released.
- connection system as a whole and the male connector in particular can be handled in the same way as with connection systems that are not provided with an adhesive arrangement. Corresponding users therefore do not have to be specially trained in order to be able to use the connection system according to the invention.
- the activation of the adhesive arrangement takes place in a simple manner by the connection of the female connector to the male connector, without additional process steps having to be carried out or specific specifications by the user having to be observed.
- connection system can be used particularly advantageously for a Luer-Lock connection system with male and female connectors that are provided with standardized geometries in accordance with the aforementioned ISO 80369-7:2021 (E).
- the activation system has an encapsulation of the adhesive arrangement by means of at least one capsule shell.
- the adhesive arrangement has at least one liquid, free-flowing or pasty adhesive component which, after destruction of the capsule shell, inevitably flows or is displaced between corresponding wall surfaces of the threads of the female and male connectors and hardens.
- the at least one capsule shell sealingly encloses a corresponding adhesive component of the adhesive assembly.
- the encapsulation can be provided by single-layer or multi-layer encapsulation of the adhesive components on the same or different encapsulation materials.
- a corresponding capsule shell can thus also be designed with one or more layers.
- One or more capsule shells can be provided for each adhesive component. The capsule shells serve to enclose primers in the same way as to enclose components of a two-component adhesive or to enclose a one-component adhesive.
- the adhesive arrangement has different adhesive components, which are accommodated in different capsule shells.
- the two different adhesive components are separated from one another by the capsule shells as long as the male and female connectors are not connected to one another.
- a primer is also provided as an adhesive component, which makes a non-adhesive material of the male connector or of the female connector adhesive before the actual adhesive of the connection system according to the invention takes effect.
- the capsule shells with the different adhesive components are positioned in the annular gap depending on an activation sequence of the adhesive components.
- the capsule shells are positioned in such a way that when the female connector dips into the annular gap of the male connector, the capsule shells with the adhesive components are first destroyed, which are necessary for an operative connection with the subsequent adhesive components or with the material of the connectors.
- the at least one capsule shell filled with the primer is destroyed first when the female connector penetrates, in order to be able to flow along the corresponding surfaces.
- the capsule shells which contain the adhesive components for the non-detachable connection between the female connector and the male connector, are subsequently destroyed. All adhesive components of the adhesive arrangement, i.e. also a corresponding primer, are liquid or flowable in their encapsulated state in the respective capsule shell in order to reliably penetrate into corresponding cavities between the internal thread of the annular gap of the male connector and the external thread of the female connector after the corresponding capsule shell has been destroyed to be able to
- the at least one capsule shell is designed to be low-resistance such that when the female connector is connected to the male connector, contact between the female connector and the capsule shell destroys the capsule shell, releasing the at least one adhesive component.
- the destruction preferably takes place through shearing and/or compressive stresses on the capsule shell due to the screwing in of the female connector. This ensures that with the connection between the female and male connectors, the adhesive arrangement is also released, so that the fixation of the connection between the female and male connectors is ensured.
- the fixation is given when the at least one adhesive component has cured.
- the at least one capsule shell provided with an adhesive component is fixed in the annular gap in a force-fitting or form-fitting or material-fitting manner. This ensures that the corresponding hollow body of capsule shell and adhesive component when handling the male connector is not unintentionally from the annular gap of the male connector falls out.
- a positive or non-positive fixation is preferably achieved by appropriate dimensioning of the at least one capsule shell and consequently the correspondingly designed hollow body such that the capsule shell including the adhesive component is introduced into the annular gap with appropriate deformation without being damaged or destroyed.
- a cohesive fixation of the hollow body and thus the capsule shell including the adhesive component enclosed by it can be achieved by an additional adhesive or by a solvent that dissolves a surface of the connector and thus enables the capsule shell to be fixed to a corresponding wall section of the annular gap of the male connector.
- the male connector and/or the female connector have an optically or haptically recognizable coding, which enables a user to distinguish them from a known connection system without an adhesive arrangement.
- the coding is designed geometrically in a suitable way.
- the connection system according to the invention is preferably marked in color in order to enable a user to distinguish it from other connection systems. This ensures that the user does not inadvertently use a connection in which the male and female connectors cannot be permanently fixed relative to one another.
- FIG. 1 schematically shows an embodiment of a device according to the invention
- connection system In the form of a Luer lock connection system,
- Fig. 2 in an enlarged sectional view of a male Luer lock connector of the
- FIG. 3 shows another male Luer lock connector according to another
- FIG. 4 is a sectional view of a male luer lock connector of another
- FIG. 5 shows a sectional view of a male Luer lock connector according to a further embodiment of a Luer lock connection system according to the invention
- Fig. 7a shows a representation similar to Fig. 6a
- FIGS. 6a and 7a shows a further sectional view similar to FIGS. 6a and 7a
- FIG. 10 shows a male Luer lock connector according to a further embodiment of a Luer lock connection system according to the invention
- FIG. 12 shows an enlarged view of a section of the arrangement according to FIG. 11 and
- FIG. 13 shows a male Luer lock connector according to a further embodiment of a Luer lock connection system according to the invention.
- a medical connection system in the form of a Luer-Lock connection system 1 according to FIG. 1 has a male Luer-Lock connector 2 and a female Luer-Lock connector 3, only partially shown.
- the male Luer lock connector 2 is provided in a manner known in principle with a Luer plug tip 4 onto which a Luer plug receptacle 5 is plugged in the connected state.
- the luer plug tip 4 of the male luer lock connector 2 and the luer plug receptacle 5 of the female luer lock connector 3 are designed to be conical, complementary to one another.
- the male Luer-Lock connector 2 also has an annular wall concentrically surrounding the Luer plug-in tip 4 at a radial distance, which is spaced apart from an outer jacket of the Luer plug-in tip 4 by an annular gap 6 .
- the annular wall has an internal thread 7 which protrudes radially into the annular gap and is provided with one or more thread turns.
- the female Luer lock connector 3 On its outer circumference, has an external thread 8 which is complementary to the internal thread 7 and which, analogously to the internal thread 7 , is provided with one or more thread turns.
- Both the female Luer lock connector 3 and the male Luer lock connector 2 are each made in one piece from a plastic material.
- the female Luer lock connector 3 with its Luer plug receptacle 5 is placed on an upper part of the Luer plug tip 4 of the male Luer lock connector 2, with a lower end edge of an annular casing of the Luer plug receptacle 5 of the female Luer lock connector 3 already partially protrudes into the annular gap 6 of the male Luer lock connector 2 .
- Luer lock connection systems 1 are described below with reference to FIGS male Luer lock connector 2 is provided and only by screwing the female Luer lock connector 3 into the annular gap 6 of the male Luer lock connector 2 is activated. Activation is to be understood as an activation of the adhesive properties of the adhesive arrangement K, which leads to the adhesive arrangement K curing and consequently to a fixing of the screwed-on connection position between the male Luer lock connector 2 and the female Luer lock connector 3 .
- the embodiments of the Luer lock connection systems 1 according to the invention described below and illustrated with reference to FIGS different embodiments are provided. The illustrated and described Luer lock connection systems 1 differ only with regard to corresponding adhesive arrangements and corresponding activation systems for these adhesive arrangements.
- an adhesive arrangement K is provided in that a plurality of small capsule shells H is introduced into the annular gap 6 of the male Luer lock connector 2, each with a liquid or flowable adhesive component are filled.
- Each capsule shell H is essentially spherical and forms a closed hollow body that encloses the adhesive component.
- the spherical capsule shells H are introduced along the thread of the internal thread 7 of the annular gap 6, so that the capsule shells H are inserted over an entire length of the Thread of the internal thread 7 are distributed.
- Corresponding outer dimensions of the capsule shells H are dimensioned such that the capsule shells H can be introduced into the annular gap 6 from above in the filled state and are each supported on an upper flank of the thread turn of the internal thread 7 .
- the capsule shells H are designed from a shell material that is destroyed under pressure and shearing stresses that arise when the male Luer lock connector 2 and the female Luer lock connector 3 are screwed together, releasing the adhesive component.
- the covering material is designed to be so resistant that it is not damaged during mechanical or manual handling during introduction into the annular gap 6 .
- the capsule shells H with the enclosed adhesive component give feedback to the user in the event of destruction during screwing between the male and female Luer lock connectors 2, 3, either by acoustically detectable bursting or tearing open of the shell material, initially by an increased and then reduced resistance when screwing in or due to the release of incorporated additives, e.g. fragrances.
- the embodiment according to FIG. 4 differs only in that the adhesive arrangement is provided in the form of a two-component adhesive, one of the two adhesive components being accommodated in each case in its own capsule shell H1, H2.
- a corresponding number of capsule shells Hi and H2 is provided.
- the capsule shells H1 and H2 are distributed evenly in the thread of the annular gap 6a such that when the female Luer lock connector is screwed into the male Luer lock connector 2a, there is always a uniform mixture of the both adhesive components takes place.
- a mixing ratio of 1:1 is provided.
- the same number of capsule casings Hi and capsule casings H2 are then provided and positioned evenly distributed in the annular gap 6a.
- the corresponding surfaces of the male and female Luer lock connectors are activated by the primer, so that improved adhesion of the adhesive arrangement to the respective surface can take place.
- the primer is also enclosed in liquid or free-flowing form by a shell material, forming capsule shells H 3 , as can be seen in FIG. Since activation of the corresponding surfaces is first necessary for a good material connection between the male and female Luer lock connector, the capsule shells H 3 filled with the primer are arranged at the top in the annular gap 6b, so that when the female Luer lock connector on the male Luer lock connector 2b, the capsule shells H 3 are first destroyed and the primer is released. When screwed in further, the capsule shells H1 and H2 are then destroyed, analogously to the previously described embodiments, as a result of which the adhesive components of the adhesive arrangement are mixed.
- a solvent O is used instead of an adhesive K1 , which leads to a dissolving of the corresponding surfaces of the annular gap 6, as a result of which the dissolved area O forms a connection with the shell material of the respective capsule shell H.
- another solvent L is used to dissolve the shell material of the respective capsule shell H itself, with this solvent L advantageously also being applied in the area of the corresponding surfaces of the annular gap 6. The dissolving of the shell material of the respective capsule shell H leads in an analogous manner to a connection between the surface of the annular gap 6 and the shell material of the capsule shell H.
- an adhesive arrangement K 2 is provided in the form of a multiplicity of adhesive drops, without an additional covering by means of a covering material being present.
- the non-encapsulated adhesive arrangement K 2 can also be introduced into the annular gap 6c in any other portioning form instead of in the form of drops.
- the adhesive arrangement K 2 can preferably be formed by a hot-melt adhesive.
- a corresponding adhesive arrangement K 3 can also be shown in FIG. 10 in the form of a ring just below a Entry area of the annular gap 6d can be introduced into the annular gap of the male Luer lock connector 2d.
- the adhesive arrangement K 3 as described with reference to FIGS H 3 is positioned.
- the primer is thus released when the female Luer lock connector is screwed in before the adhesive arrangement K 3 is distributed in the annular gap 6f by screwing in the female Luer lock connector, so that the corresponding contact surfaces of the female Luer lock connector Connector and the male Luer lock connector 2f were activated by the primer before the adhesive arrangement K 3 is distributed and activated and then hardens.
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN202280041335.0A CN117479976A (zh) | 2021-06-08 | 2022-06-08 | 用于医疗应用的连接*** |
EP22733561.9A EP4351697A1 (de) | 2021-06-08 | 2022-06-08 | Verbindungssystem für medizinische anwendungen |
US18/567,176 US20240149038A1 (en) | 2021-06-08 | 2022-06-08 | Connection system for medical applications |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102021205771.3 | 2021-06-08 | ||
DE102021205771.3A DE102021205771A1 (de) | 2021-06-08 | 2021-06-08 | Verbindungssystem für medizinische Anwendungen |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2022258646A1 true WO2022258646A1 (de) | 2022-12-15 |
Family
ID=82214299
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP2022/065464 WO2022258646A1 (de) | 2021-06-08 | 2022-06-08 | Verbindungssystem für medizinische anwendungen |
Country Status (5)
Country | Link |
---|---|
US (1) | US20240149038A1 (de) |
EP (1) | EP4351697A1 (de) |
CN (1) | CN117479976A (de) |
DE (1) | DE102021205771A1 (de) |
WO (1) | WO2022258646A1 (de) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102022208343A1 (de) | 2022-08-11 | 2024-02-22 | B. Braun Melsungen Aktiengesellschaft | Medizinisches Fluidkonnektorsystem |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0829652A2 (de) * | 1996-09-14 | 1998-03-18 | Daimler-Benz Aktiengesellschaft | Fügeverbindung |
EP0935078A1 (de) * | 1998-02-05 | 1999-08-11 | DaimlerChrysler AG | Einrichtung zur Erkennung eines überbelastungsbedingten Ermüdungsbruches einer Schraubverbindung |
US20060047251A1 (en) | 2002-10-22 | 2006-03-02 | Philip Bickford Smith | Medical small-bore tubing system and kit |
DE102018220074A1 (de) * | 2018-11-22 | 2020-05-28 | Robert Bosch Gmbh | Lenkgetriebe und Verfahren zur Montage eines solchen Lenkgetriebes |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5233739A (en) | 1990-07-30 | 1993-08-10 | Dayco Products, Inc. | Adhesive bonding expanded insert hose construction assembly |
DE19960226C1 (de) | 1999-12-14 | 2001-05-10 | Fresenius Ag | Sterilitäterhaltendes Konnektionssystem für medizinische Systeme und dessen Verwendung |
-
2021
- 2021-06-08 DE DE102021205771.3A patent/DE102021205771A1/de active Pending
-
2022
- 2022-06-08 US US18/567,176 patent/US20240149038A1/en active Pending
- 2022-06-08 WO PCT/EP2022/065464 patent/WO2022258646A1/de active Application Filing
- 2022-06-08 EP EP22733561.9A patent/EP4351697A1/de active Pending
- 2022-06-08 CN CN202280041335.0A patent/CN117479976A/zh active Pending
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0829652A2 (de) * | 1996-09-14 | 1998-03-18 | Daimler-Benz Aktiengesellschaft | Fügeverbindung |
EP0935078A1 (de) * | 1998-02-05 | 1999-08-11 | DaimlerChrysler AG | Einrichtung zur Erkennung eines überbelastungsbedingten Ermüdungsbruches einer Schraubverbindung |
US20060047251A1 (en) | 2002-10-22 | 2006-03-02 | Philip Bickford Smith | Medical small-bore tubing system and kit |
DE102018220074A1 (de) * | 2018-11-22 | 2020-05-28 | Robert Bosch Gmbh | Lenkgetriebe und Verfahren zur Montage eines solchen Lenkgetriebes |
Also Published As
Publication number | Publication date |
---|---|
CN117479976A (zh) | 2024-01-30 |
US20240149038A1 (en) | 2024-05-09 |
DE102021205771A1 (de) | 2022-12-08 |
EP4351697A1 (de) | 2024-04-17 |
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