WO2003022561A1 - Mehrschichtiger kunststoffkörper für medizinische anwendungen - Google Patents
Mehrschichtiger kunststoffkörper für medizinische anwendungen Download PDFInfo
- Publication number
- WO2003022561A1 WO2003022561A1 PCT/CH2002/000464 CH0200464W WO03022561A1 WO 2003022561 A1 WO2003022561 A1 WO 2003022561A1 CH 0200464 W CH0200464 W CH 0200464W WO 03022561 A1 WO03022561 A1 WO 03022561A1
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- Prior art keywords
- layer
- plastic
- plastic body
- plastic material
- body according
- Prior art date
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
- B29C45/16—Making multilayered or multicoloured articles
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- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
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- B29C45/16—Making multilayered or multicoloured articles
- B29C45/1642—Making multilayered or multicoloured articles having a "sandwich" structure
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- B32B7/02—Physical, chemical or physicochemical properties
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B2439/00—Containers; Receptacles
- B32B2439/80—Medical packaging
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
- Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
- Y10T428/1393—Multilayer [continuous layer]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/24—Structurally defined web or sheet [e.g., overall dimension, etc.]
- Y10T428/24942—Structurally defined web or sheet [e.g., overall dimension, etc.] including components having same physical characteristic in differing degree
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/31504—Composite [nonstructural laminate]
Definitions
- the invention relates to a multi-layer plastic body for handling medical, diagnostic, pharmaceutical and cosmetic products.
- the plastic body primarily serves for the storage or passage of fluid products, including gel-shaped products, or is provided for their storage or passage.
- a number of plastics have the property of forming cracks under mechanical loads and the action of a fluid, ie a liquid, a gas or a gel, which can cause components made from such plastics to fail.
- the mechanical loads can be caused by an external force acting on a component and / or by internal stresses.
- the fluid interacts physically with the plastic, but the cracking only occurs when the plastic material in question is under tension.
- the tensile stress can be brought about by an external force or in particular by internal stresses, ie frozen strains and transverse stresses. This behavior is also known as stress cracking or environmental stress cracking (ESC).
- the fluid acting on the plastic can be the product to be passed through or stored, or a fluid from the external environment of the plastic body, for example alcohol, or a component of a fluid, for example atmospheric oxygen, or another surrounding material, for example skin-tight.
- a fluid from the external environment of the plastic body for example alcohol
- a component of a fluid for example atmospheric oxygen, or another surrounding material, for example skin-tight.
- an external impact In most applications, an action from the inside and an action from the outside occur together, with one in many applications of these actions, which is more critical for crack formation, the prevention or at least disability of which one can concentrate.
- the at least two layers are bonded together. If the plastic body has more than two layers arranged one above the other, in such embodiments each of these layers is preferably integrally bonded to each layer immediately below or above it.
- the connection of the two or more layers can also be purely positive. Especially in sandwich injection molding (co-injection), a preferred manufacturing process, there is only a positive connection. if considered. Furthermore, the connection can be positive and material. Finally, it should also not be ruled out that the connection also partially has the character of a frictional connection, although the production is directed either to a material connection or a positive connection or a combination of a material and a positive connection. Even in the case of purely form-fitting connections of more than two layers, the form-fitting connections can only exist in pairs, as previously described for the material-fit connection, between immediately adjacent layers.
- not all layers of the plastic body have to enclose the cavity, although this can be preferred.
- one of the layers can form a cavity wall in a first area of the plastic body and another of the layers can form a cavity wall in another area of the plastic body.
- at least the first layer of the stress-crack-resistant plastic material with the exception of one or more openings, completely encloses the cavity in order to obtain the required tightness for the passage or storage of the product.
- the product to be handled is preferably a medical, diagnostic, pharmaceutical or cosmetic product.
- pharmaceutical products are insulin for diabetes therapy or growth hormones or irrigation fluids for dialysis.
- Rinsing fluids are also used in diagnostics to flush body fluids from the human body by means of perfusion and, for example, to make them easier to identify and / or quantify ingredients.
- Cosmetic products are often in gel form, for example as creams or ointments.
- the invention is based on the knowledge that the diverse properties which are placed on containers, catheters and other components of fluid systems, in particular in the medical and diagnostic fields, cannot be fulfilled by a single plastic material, at least not in an optimal manner.
- the group of semi-crystalline plastics has sufficient resistance to stress cracking.
- the stress-crack-resistant plastic material of the first layer is preferably selected from this group.
- the semi-crystalline plastics are usually not transparent, but opaque. Their mechanical strength and dimensional stability also do not meet the requirements of most applications.
- the stress-crack-resistant plastic material becomes selected so that it is resistant to stress cracking against the main causer or even more preferably against possibly several stress crack initiators.
- the thickness of the first layer is so small that the first layer has sufficient light has the permeability required for the storage or transit of products, in particular in medical and pharmaceutical applications, in order to be able to visually check the quantity and / or the quality of the product in question.
- the thin first layer is transparent or at least translucent, although the plastic as such would be opaque with a larger layer thickness.
- the second layer or several different plastic layers are arranged between two layers each made of a stress-crack-resistant plastic material.
- One of these two outer layers is in contact with the environment, in most applications of the atmospheric environment, and the other outer layer is preferably an innermost cladding layer which forms a surface towards the product or, if the product is a fluid, preferably directly with it is in contact with the product fluid.
- the plastic body should therefore have the lowest possible permeability for the substances relevant in the respective application.
- the substances that are to be prevented from penetrating can in particular be the constituents of gases, such as oxygen and nitrogen from the ambient air.
- gases such as oxygen and nitrogen from the ambient air.
- the plastic body is preferably designed in such a way that escape of the product or individual products of substances is prevented.
- the plastic body has a layer which acts as a diffusion barrier. This layer can be formed by the second layer. It can also be formed by a further, third layer or, in principle, also by the first layer if the stress-crack-resistant plastic itself already has the required low permeability in relation to the substance to be prevented from diffusion or the plurality of substances to be prevented from diffusion.
- the plastic body is preferably a container, a catheter or a component in a fluid guide system, for example a connecting element for connecting two catheters or a so-called catheter head, or part of such a component.
- the plastic body can also be a housing or a housing part of a device, for example an injection device or an infusion device.
- a housing should not be in contact with the product to be administered, for example insulin, it can happen that the product comes into contact with the housing and has a stress-cracking effect.
- the plastic body is preferably manufactured in multi-component injection molding, so that the material connection and / or form connection between the at least two layers of a wall according to the invention is also produced directly during the shaping.
- a particularly preferred method for producing the plastic body is the co-injection method, which is also referred to as sandwich multi-component injection molding.
- the method is fundamentally known from other areas, but according to the invention is used profitably for the manufacture of a plastic body for the handling of health and beauty care products using a stress-crack-resistant plastic material.
- the multiple layers of the plastic body are molded simultaneously or immediately one after the other in an injection molding tool.
- the layers can also be formed by simultaneous injection during one injection phase and successive injection during another phase.
- the plastic body or a part thereof can instead also be manufactured as a composite injection molded part.
- the combination of composite injection molding and co-injection multi-component injection molding is a preferred type of production.
- FIG. 2 shows an ampoule formed by co-injection multi-component injection molding
- FIG. 4 shows an ampoule formed by composite injection molding
- Figure 5 shows a portion of a co-extruded catheter.
- Figure 1 shows the production of a multilayer plastic body 4 by means of co-injection multi-component injection molding.
- Plastic material is injected into an injection mold of the tool through an injection nozzle 3 of an injection molding tool.
- the injection nozzle 3 is used to inject a stress-resistant plastic material, which in the hardened state is preferably partially crystalline with a proportion of the crystalline phase of preferably at least 30% by weight to form an outer layer 1 up to a partial filling of the mold.
- the partial filling is indicated by the fact that a hollow cross section 10 of the mold in a region remote from the injection nozzle 3 initially only fills with the plastic material forming the outer layer.
- the second layer 2 is a core layer which is completely enclosed in the plastic material of the outer layer 1.
- the two plastic materials are injected coaxially through the same injection nozzle 3, the material of the outer layer 1 surrounding that of the second layer 2.
- the hollow cross section 10 of the mold is filled, so that the layer structure shown in FIG. 2 results for the plastic body 4.
- FIG. 2 shows the plastic body 4 after removal from the injection mold of Figure 1.
- the plastic body 4 forms a simple, open on one side cylinder pot for storing liquids, for example.
- FIG. 3 shows a container 5, in the exemplary embodiment an ampoule, for storing a liquid active ingredient solution, for example insulin or a growth hormone.
- the ampoule 5 also has a core layer 2, which is enclosed in an outer layer 1.
- the ampoule 5 has an opening 6 which is closed sterile, in particular airtight, by a septum 8.
- the septum 8 can be easily pierced by a needle and closes the previous puncture site tightly after the needle is pulled out. Since such septa are well known in ampoules for medical and pharmaceutical applications, no further description is given.
- the septum 8 can be a prefabricated plastic body which is inserted into the mold prior to the injection molding process and is extrusion-coated with the other two plastic materials during the injection in the manner shown, as was described with reference to the exemplary embodiment in FIGS. 1 and 2.
- the septum 8 can also be formed in the injection mold at the same time or immediately before or after the injection of the other plastic materials by injecting a plastic material provided for this purpose into the injection mold.
- the ampoule 5 with septum 8 is obtained by means of a combination of co-injection multi-component injection molding and composite injection molding, the two-component ampoule 5 being obtained by means of co-injection and the closure of the opening 6 by means of composite injection molding.
- the ampoule of FIG. 3 is open at its end opposite the opening 6 by simply running out as a hollow cylinder.
- it is already telbar suitable for use as an ampoule for an injection device or infusion device, since in such uses a plunger serving to distribute the product generally closes the ampoule 5 at its open end in a product-tight manner.
- FIG. 4 shows an ampoule 10 which is similar in shape to ampoule 5 of the exemplary embodiment in FIG. 3 and in particular can also be used as an ampoule for an injection or infusion device.
- the ampoule 10 is designed as a composite injection molded part. Furthermore, it does not have an outer layer that is resistant to stress cracking, but only the inner layer 1 that is resistant to stress cracking. While the several plastic components are injected at the same time or at least virtually simultaneously during the co-injection, the multiple plastic components are introduced sequentially in the composite injection molding and for each of the plastic materials by at least its own nozzle.
- the septum 8 of the exemplary embodiments in FIGS. 3 and 4 can be injected into the mold by means of a separate injection nozzle provided specifically for the material of the septum 8, while the layers 1 and 2 are jointly injected through one or more injection nozzles, preferably as in the exemplary embodiments of Figures 1, 2 and 3 or sequentially as in the example of Figure 4, are injected.
- FIG. 5 shows a length section of a catheter 11 which has been coextruded from two plastic materials.
- One of the plastic materials forms the thin stress-crack-resistant outer skin 1 and the other the inner layer 2, which comes into contact with the product to be passed through.
Abstract
Description
Claims
Priority Applications (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA2459932A CA2459932C (en) | 2001-09-12 | 2002-08-26 | Multi-layered plastic body for medical applications |
EP02754094A EP1425160A1 (de) | 2001-09-12 | 2002-08-26 | Mehrschichtiger kunststoffkörper für medizinische anwendungen |
JP2003526666A JP2005501679A (ja) | 2001-09-12 | 2002-08-26 | 医療用途用の多層プラスチック体 |
US10/798,971 US7374802B2 (en) | 2001-09-12 | 2004-03-11 | Multi-layered plastic body for medical applications |
US12/122,814 US7799400B2 (en) | 2001-09-12 | 2008-05-19 | Multi-layered plastic body for medical applications |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE10144892.9 | 2001-09-12 | ||
DE10144892A DE10144892B4 (de) | 2001-09-12 | 2001-09-12 | Mehrschichtiger Kunststoffkörper |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/798,971 Continuation US7374802B2 (en) | 2001-09-12 | 2004-03-11 | Multi-layered plastic body for medical applications |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2003022561A1 true WO2003022561A1 (de) | 2003-03-20 |
Family
ID=7698757
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/CH2002/000464 WO2003022561A1 (de) | 2001-09-12 | 2002-08-26 | Mehrschichtiger kunststoffkörper für medizinische anwendungen |
Country Status (6)
Country | Link |
---|---|
US (2) | US7374802B2 (de) |
EP (1) | EP1425160A1 (de) |
JP (1) | JP2005501679A (de) |
CA (1) | CA2459932C (de) |
DE (1) | DE10144892B4 (de) |
WO (1) | WO2003022561A1 (de) |
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US10561817B2 (en) | 2014-05-30 | 2020-02-18 | Hollister Incorporated | Flip open catheter package |
US10737013B2 (en) | 2014-07-08 | 2020-08-11 | Hollister Incorporated | Portable trans anal irrigation device |
US10765796B2 (en) | 2014-07-08 | 2020-09-08 | Hollister Incorporated | Trans anal irrigation platform with bed module |
US11020561B2 (en) | 2016-04-22 | 2021-06-01 | Hollister Incorporated | Medical device package with a twist cap |
US11103676B2 (en) | 2016-04-22 | 2021-08-31 | Hollister Incorporated | Medical device package with flip cap having a snap fit |
US11383021B2 (en) | 2016-07-08 | 2022-07-12 | Hollister Incorporated | Wireless electronic pump design for a body cavity irrigation device |
US11497844B2 (en) | 2016-12-14 | 2022-11-15 | Hollister Incorporated | Transanal irrigation device and system |
US11666730B2 (en) | 2017-12-08 | 2023-06-06 | Hollister Incorporated | Package for medical device for ergonomic device removal |
US11707599B2 (en) | 2017-02-21 | 2023-07-25 | Hollister Incorporated | Medical device package with twist-off cap |
US11771865B2 (en) | 2017-10-25 | 2023-10-03 | Hollister Incorporated | Caps for catheter packages |
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US7947236B2 (en) | 1999-12-03 | 2011-05-24 | Becton, Dickinson And Company | Device for separating components of a fluid sample |
US20110172644A1 (en) * | 2002-12-04 | 2011-07-14 | Zanoni Michael S | Multi layer coextruded catheter shaft |
US7601285B2 (en) * | 2003-12-31 | 2009-10-13 | Boston Scientific Scimed, Inc. | Medical device with varying physical properties and method for forming same |
DE102005042678A1 (de) | 2004-12-24 | 2006-07-06 | Rasmussen Gmbh | Verfahren zur Herstellung eines Stutzens |
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CN102149472B (zh) | 2008-07-21 | 2014-08-13 | 贝克顿·迪金森公司 | 密度相分离装置 |
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US9145251B2 (en) | 2012-10-26 | 2015-09-29 | Berry Plastics Corporation | Package |
US9681833B2 (en) * | 2014-04-18 | 2017-06-20 | Tekni-Plex, Inc. | Coextruded plastic capillary tube |
EP3157726A1 (de) * | 2014-06-20 | 2017-04-26 | Lameplast S.p.A. | Verfahren zur herstellung von phiolenstreifen für flüssige produkte, insbesondere für medizinische, pharmazeutische, kosmetische, nahrungsmittelprodukte oder dergleichen |
US9694359B2 (en) | 2014-11-13 | 2017-07-04 | Becton, Dickinson And Company | Mechanical separator for a biological fluid |
US10532872B2 (en) | 2014-12-08 | 2020-01-14 | Berry Plastics Corporation | Package |
US10875224B2 (en) | 2015-08-28 | 2020-12-29 | Hollister Incorporated | Method and apparatus for molding an elongated hollow article |
US11446467B2 (en) * | 2018-09-25 | 2022-09-20 | Smiths Medical Asd, Inc. | Overmolded septum for catheter hub |
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- 2002-08-26 JP JP2003526666A patent/JP2005501679A/ja active Pending
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- 2002-08-26 EP EP02754094A patent/EP1425160A1/de not_active Ceased
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Cited By (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10183112B2 (en) | 2013-08-30 | 2019-01-22 | Hollister Incorporated | Device for trans anal irrigation |
US11116891B2 (en) | 2013-08-30 | 2021-09-14 | Hollister Incorporated | Device for trans anal irrigation |
US10561817B2 (en) | 2014-05-30 | 2020-02-18 | Hollister Incorporated | Flip open catheter package |
US11534573B2 (en) | 2014-05-30 | 2022-12-27 | Hollister Incorporated | Flip open catheter package |
US11497845B2 (en) | 2014-07-08 | 2022-11-15 | Hollister Incorporated | Trans anal irrigation platform with bed module |
US10737013B2 (en) | 2014-07-08 | 2020-08-11 | Hollister Incorporated | Portable trans anal irrigation device |
US10765796B2 (en) | 2014-07-08 | 2020-09-08 | Hollister Incorporated | Trans anal irrigation platform with bed module |
US11020561B2 (en) | 2016-04-22 | 2021-06-01 | Hollister Incorporated | Medical device package with a twist cap |
US11103676B2 (en) | 2016-04-22 | 2021-08-31 | Hollister Incorporated | Medical device package with flip cap having a snap fit |
US11813409B2 (en) | 2016-04-22 | 2023-11-14 | Hollister Incorporated | Medical device package with flip cap having a snap fit |
US11833312B2 (en) | 2016-04-22 | 2023-12-05 | Hollister Incorporated | Medical device package with flip cap having a snap fit |
US11383021B2 (en) | 2016-07-08 | 2022-07-12 | Hollister Incorporated | Wireless electronic pump design for a body cavity irrigation device |
US11497844B2 (en) | 2016-12-14 | 2022-11-15 | Hollister Incorporated | Transanal irrigation device and system |
US11707599B2 (en) | 2017-02-21 | 2023-07-25 | Hollister Incorporated | Medical device package with twist-off cap |
US11771865B2 (en) | 2017-10-25 | 2023-10-03 | Hollister Incorporated | Caps for catheter packages |
US11666730B2 (en) | 2017-12-08 | 2023-06-06 | Hollister Incorporated | Package for medical device for ergonomic device removal |
Also Published As
Publication number | Publication date |
---|---|
DE10144892A1 (de) | 2003-03-27 |
US7799400B2 (en) | 2010-09-21 |
CA2459932A1 (en) | 2003-03-20 |
JP2005501679A (ja) | 2005-01-20 |
CA2459932C (en) | 2010-10-12 |
US20080286575A1 (en) | 2008-11-20 |
US7374802B2 (en) | 2008-05-20 |
DE10144892B4 (de) | 2005-09-08 |
EP1425160A1 (de) | 2004-06-09 |
US20040241364A1 (en) | 2004-12-02 |
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