WO2002066595A1 - Septum d'orifice d'acces et assemblage - Google Patents

Septum d'orifice d'acces et assemblage Download PDF

Info

Publication number
WO2002066595A1
WO2002066595A1 PCT/US2001/043724 US0143724W WO02066595A1 WO 2002066595 A1 WO2002066595 A1 WO 2002066595A1 US 0143724 W US0143724 W US 0143724W WO 02066595 A1 WO02066595 A1 WO 02066595A1
Authority
WO
WIPO (PCT)
Prior art keywords
septum
access port
antimicrobial agent
elastomeric
slit
Prior art date
Application number
PCT/US2001/043724
Other languages
English (en)
Inventor
Emilio Barbera-Guillem
Rick D. Lucas
M. Bud Nelson
Original Assignee
Biocrystal, Ltd.
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 Biocrystal, Ltd. filed Critical Biocrystal, Ltd.
Publication of WO2002066595A1 publication Critical patent/WO2002066595A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • 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
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
    • C12M37/00—Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination
    • C12M37/04—Seals

Definitions

  • the present invention relates to a septum for use in access ports of vessels; and more particularly to a self-sealing, compressed septum for providing and maintaining a leak-proof, sterile seal.
  • access ports permit a user to access fluids; i.e., introduce fluids into a reaction vessel or withdraw fluids contained within the reaction vessel.
  • fluids i.e., introduce fluids into a reaction vessel or withdraw fluids contained within the reaction vessel.
  • a septum which can provide a closure, which is puncturable, and is capable of resealing in a leak-proof manner even after multiple punctures.
  • a reaction vessel such as the cell culture device disclosed in U.S. application number 09/526,006 (the disclosure of which is herein incorporated by reference in its entirety), may further comprise a septum which is inserted and extends into an access port.
  • the septum should permit the introduction of a tip through the septum and into the access port, seal tightly around the tip to prevent leakage through the septum while the tip is present in the septum, allow withdrawal of the tip without unduly restricting the passage of the tip through the septum, and allow for resealing of the septum in maintaining a barrier to contamination of the contents inside the reaction vessel.
  • FIG. 1 illustrates this drawback of conventional septum designs. As illustrated in FIG. 1, there is a tendency of devices to form leaks when a tip is inserted in a septum.
  • gaps 10 are formed by slit deformation around the outer surface of tip 5 where the slit does not conform exactly to the outside surface of the tip resulting in a failure of the slit to completely close at its outer-most ends.
  • This failure leads to a partially open slit.
  • a partially open slit results in passages which create an increased risk of contaminants (e.g., microbes) to enter through open portions of the slit, and to be subsequently introduced through the septum into the sterile environment of the device.
  • contaminants e.g., microbes
  • conventional septum materials, and structural integrity offered by conventional septum designs simply break down after multiple tip insertions, thereby also affecting the ability of a septum to seal around a tip or reseal after a tip has been removed.
  • microbes (used herein to encompass bacteria, fungus, viruses, and yeast, particularly those microbes which are known to serve as sources of contamination in cell cultures) easily grow in warm and humid places, environmental conditions in which cells are typically cultured.
  • a surface of a cell culture exposed to humidity and warmth is conducive to the growth of microbes. If that surface also serves as an access to the culture chamber of a cell culture device (such as the exterior surface of a septum), then that surface serves as a potential source of microbial contamination of cell cultures contained in the cell culture device if microbes on that surface are carried through the access way by an inserted tip.
  • One method to counter the presence and growth of microbes on the surface is to apply a disinfectant to the surface, by wiping the surface prior to each and every tip insertion.
  • a disinfectant provides only temporary antimicrobial protection of the treated surface, as once the disinfectant wears off, the surface will continue to present a suitable environment conducive to microbial growth.
  • a pre-slit septum which, when accommodated by an access port, can minimize leakage through its slit during and after being penetrated by a tip in maintaining a leak-proof seal that serves as a barrier to contamination even after repeatedly being accessed by a tip.
  • a pre-slit septum which has an antimicrobial agent incorporated therein which can migrate to the exterior surface of the septum in providing antimicrobial protection which is also a barrier to contamination.
  • the invention provides for an elastomeric, pre-slit septum which is dimensioned to cause centrally directed compression, when inserted in an access port configured to accommodate the septum, such that: (a) when a tip is inserted into and accesses the slit of the septum-access port assembly, the slit closes around and sealingly engages the outer surface of a tip accessing the septum to prevent leakage between the tip and slit so as to maintain a leak-proof seal; and (b) enhances the ability of the septum to reseal itself (“resealability") after withdrawal of the tip from the slit, even after the septum has been repeatedly accessed by tips.
  • resealability enhances the ability of the septum to reseal itself
  • the elastomeric pre-slit septum further comprises an antimicrobially effective amount of a substantially non-toxic (e.g., to cultured mammalian cells) antimicrobial agent which is incorporated into the matrix (including spaces therein) of the septum material in a manner that allows antimicrobial agent to migrate from the matrix to the exterior surface of the septum when the antimicrobial agent on the septum surface becomes depleted.
  • a substantially non-toxic (e.g., to cultured mammalian cells) antimicrobial agent which is incorporated into the matrix (including spaces therein) of the septum material in a manner that allows antimicrobial agent to migrate from the matrix to the exterior surface of the septum when the antimicrobial agent on the septum surface becomes depleted.
  • FIG. 1 is a perspective view of a conventional septum having a tip inserted therethrough;
  • FIG. 2 is a cross sectional view of a septum according to the present invention.
  • FIG. 3 is a perspective view of a septum according to the present invention
  • FIG. 4 is a front view of a septum according to the present invention
  • FIG. 5 is a cross sectional view of an embodiment of a septum-access port assembly according to the present invention.
  • FIG. 6 is a cross sectional view of another embodiment of the septum according to the present invention
  • FIG. 7 is a cross sectional view of another embodiment of the septum according to the present invention.
  • FIG. 8 is a cross sectional view of another embodiment of the septum according to the present invention.
  • FIG. 9 is a cross sectional view of another embodiment of the septum according to the present invention.
  • FIG. 10 is a cross sectional view of another embodiment of the septum according to the present invention.
  • FIG. 11 is a cross sectional view of another embodiment of the septum according to the present invention.
  • FIG. 12 is a cross sectional view of another embodiment of the septum according to the present invention.
  • FIG. 13 is a cross sectional view of another embodiment of the septum according to the present invention.
  • FIG. 14 is a cross sectional view of another embodiment of the septum according to the present invention.
  • FIG. 15 is a cross sectional view of another embodiment of the septum according to the present invention.
  • slit is used herein, for purposes of the specification and claims, to mean an opening which forms a passageway extending through substantially the entire septum body, as will be more apparent from the following descriptions.
  • the slit is normally biased closed but may be openable under pressure of a tip in inserting the tip through the slit in allowing the tip to pass through the opening comprising the slit.
  • the opening may comprise a form which includes, but is not limited to, a slot, a hole, a star-shaped incision, an eye-shaped incision, an incision, and a bore.
  • the term "device” is used herein, for purposes of the specification and claims, to mean a vessel which is used in scientific and/or biomedical applications in which there is a closed environment (e.g., chamber) formed by the device, and wherein it may be desired to introduce into or withdraw from the closed environment a fluid, while maintaining the sterility of the closed environment (including the sterility of contents that may be contained therein).
  • the device is a cell culture device.
  • the device is a cell culture device disclosed in U.S. application number
  • the cell culture device is comprised of a frame to which is contacted and secured taut thereto, in a leak-proof sealing arrangement, two liquid impermeable membranes. At least one of the membranes is gas-permeable.
  • the chamber of the cell culture apparatus, formed by the frame and membranes, is accessed by at least one access port which extends between the outer surface of the frame and the chamber.
  • the at least one access port serves as a means by which substances (e.g., cells in a fluid and/or tissue culture growth medium) can be introduced into, or withdrawn from, the chamber which is maintained as sterile.
  • the at least one access port is sealed by a septum which comprises an elastomeric, gasket material that fills all or a substantial portion of the access port, and which is sufficiently pliable to be self-sealing; e.g., thereby allowing for penetration by a tip, and resealing after tip withdrawal.
  • a septum which comprises an elastomeric, gasket material that fills all or a substantial portion of the access port, and which is sufficiently pliable to be self-sealing; e.g., thereby allowing for penetration by a tip, and resealing after tip withdrawal.
  • contamination is used herein, for purposes of the specification and claims, to mean the introduction of microbes (e.g., one or more of bacteria, virus, fungi, yeast, and the like) through the septum and into the closed environment which was maintained as sterile until such introduction occurs.
  • microbes e.g., one or more of bacteria, virus, fungi, yeast, and the like
  • tip is used herein, for purposes of the specification and claims, to mean a hollow body which may include, but is not limited to, a micropipette tip, a blunt-ended needle, a syringe needle, a blunt cannula, and the like, hi a preferred embodiment, the tip comprises a micropipette tip or a blunt-ended needle.
  • substantially insoluble in water is used herein, for purposes of the specification and claims, and with respect to an antimicrobial agent, to mean that the antimicrobial agent is either not soluble in water or has low solubility in water (e.g., has a solubility in water at 20°C of less than O.lgm liter, and more preferably of less than 0.05 gms/liter).
  • substantially non-toxic is used herein, for purposes of the specification and claims, and with respect to an antimicrobial agent, to mean that the antimicrobial agent, as used in the present invention, lacks toxicity with respect to cultured cells (e.g., mammalian cells) or is of such low toxicity that it does not prevent the growth of the cells in a cell culture device if the antimicrobial agent contacts the cells, as will be more apparent from the following descriptions.
  • cultured cells e.g., mammalian cells
  • FIGS. 2-5 An elastomeric septum 21 is illustrated in FIGS. 2-5 and is preferably adapted to be inserted into an access port such as that of a cell culture device and to receive a variety of sizes of tips.
  • Septum 21 comprises septum body 23, centrally-disposed curved surface 25 on at least one end of septum body 23, and a centrally located slit 27.
  • the centrally-disposed curved surface may be of a generally concave, convex, or conical shape.
  • the centrally-disposed curved surface is concave and present on each end of the septum, as illustrated in FIGS. 2, 3, and 5.
  • Other embodiments of the shape of a septum according to the present invention are illustrated in FIGS. 6 through 15.
  • a preferred shape of the septum may be used to the exclusion of a shape other than the preferred shape.
  • the septum is comprised of a suitable elastomeric material, and may further comprise one or more additives such as a colorant, filler, and the like.
  • the elastomeric material may be natural or synthetic.
  • the elastomeric material may be a material including, but not limited to, silicone rubber, fluoro-carbon rubber, butyl rubber, polychloroprene rubber, a silicone elastomer composite material, thermoplastic elastomer, medical grades of silicone rubber, polyisoprene, a synthetic isoprene, and a combination thereof.
  • the elastomeric material is substantially nontoxic to cultured cells (e.g., mammalian cells of a cell culture). Additionally, it is preferred that the elastomeric material is compatible with sterilization processes such as gamma irradiation.
  • the elastomeric material may be selected to have a Shore A durometer within the range of from about 30 to about 80.
  • the elastomeric material composition and durometer provide a combination that provides superior resealing qualities, particularly when utilized in the septum-access port assembly according to the present invention, as well as certified as nontoxic to cultured cells by a standard assay known in the art.
  • a septum body comprised of a thermoplastic rubber with a Shore A durometer in the range of from about 45 to about 65, and which has the desired resealing properties when used according to the present invention so that leakage does not occur even after being repeatedly accessed by a tip.
  • the septum body is comprised of a thermoplastic rubber marketed as S ANTOPRENE (available from Advanced Elastomer Systems, USA) with a Shore A durometer of about 55.
  • the septum may be manufactured using methods known in the art, such as by a molding process.
  • the precise dimensions of the septum may be varied depending on factors such as the depth and size of the access port, the forces needed to maintain the septum in position in a radially compressed manner once inserted into and accommodated by the access port, the septum composition (e.g., type of elastomeric material), and the composition of the walls of the access port which contacts the septum body.
  • the length 32 of the septum body from edge to edge is about 3.8 mm
  • the width dimension 34 of the septum body is about 5.9 mm.
  • the precise dimensions of the slit may be, in part, determined by the choice of elastomeric material used in construction of the septum, the septum dimensions, and the different sizes of tips desired to be accommodated by the septum, h continuing with the illustrative dimensions of the septum, the slit length is about 3.0 mm in extending entirely through the length of the septum, and the diameter of the slit is about 0.8 mm.
  • the precise dimensions of the access port in part, will be determined by the size and composition of the septum, the type of device, and the choice of material used in construction of the access port.
  • the access port (particularly the septum-receiving portion as described in more detail herein) is generally oval in enabling the access port to compress the inserted septum in accordance with the present invention.
  • the septum-receiving portion of the access port may comprise an oval that is 4 mm by 6.8 mm. The septum may then be compressed by between approximately 10% and 35% to be inserted into and friction fitted with the access port.
  • the septum further comprises an antimicrobial agent that is incorporated therein in an effective amount to allow the septum to continuously inhibit microbial growth and promote a microbial-free surface during the useful life of the septum.
  • an elastomeric septum dimensioned to be compressed by an access port (e.g., of a device for culturing cells) so as to compress the septum's slit to close around and sealingly engage the outer surface of an inserted tip to prevent leakage between the tip and slit so as to maintain a leak-proof seal
  • the septum comprises an elastomeric material and an antimicrobial agent mixed and formed into the elastomeric septum, wherein the antimicrobial agent becomes incorporated into the elastomeric septum and forms a surface coating on the elastomeric septum, and wherein the antimicrobial agent exhibits migration through the elastomeric septum as the surface coating of antimicrobial agent is depleted.
  • An antimicrobial agent preferably has
  • (c) has sufficient heat stability so as to retain an effective potency of antimicrobial activity after being exposed to temperatures needed to mold the elastomeric material in fabricating the septum (e.g., withstand temperatures involved in melting the septum material); (d) is substantially non-toxic with respect to cultured cells, as may be encountered if the antimicrobial agent comes in contact with cells being cultured in a cell culture device;
  • (e) is dispersible in the elastomeric material used to fabricate the septum
  • (f) has broad spectrum antimicrobial activity, particularly against microbes commonly encountered in cell culture environments, and more preferably, against gram-positive bacteria, gram-negative bacteria, viruses, yeast, and fungi;
  • the antimicrobial agent may be a single agent or a combination of agents.
  • the antimicrobial agent is non-ionic and substantially insoluble in water. Suitable non-ionic antimicrobial agents may include, but are not limited to, phenol derivatives, diphenyl derivatives, diphenyl ethers, chlorinated phenoxys, dichlorophenes, and the like.
  • triclosan (2,4,4'-trichloro- 2'hydroxydiphenyl ether), 5-chloro-2-(2,4-dichlorophenoxy)phenol, and 2-2'-methylene-bis- 4-chloro-phenol.
  • suitable antimicrobial agents may include, but are not limited to, 3- (trifluomethyl)-4,4'-dichloro-carbanilide, or a cationic agent that is substantially insoluble in water. Examples of the latter may include, but are not limited to, biguanide compounds or salts thereof, and more preferably may comprise polyhexamethylene biguanide hydrochlori.de.
  • the antimicrobial agent may further comprise a stabilizer, which is an effective amount to protect the potency of the antimicrobial agent during the process of fabricating the septum, such as an anti-oxidant.
  • a stabilizer may include, but are not limited to, hindered phenols, polyphenols, phosphates, thioesters, and the like.
  • the process of incorporating the antimicrobial agent into the septum material will depend on factors which include, but are not limited to, the nature of the antimicrobial agent, the nature of the elastomeric material comprising the septum, and the method of fabricating the septum.
  • the antimicrobial agent is embedded in the septum during manufacture such as uniformly mixing the antimicrobial agent with the elastomeric material which is in a fluid state prior to molding, and then the mixture is molded to form the septum.
  • an effective amount of the antimicrobial agent may be in powder form or may be mixed with a portion of the elastomeric material in forming a dispersion, and then is gradually mixed with the elastomeric material until a homogenous mixture is obtained.
  • the antimicrobial agent is added to the elastomeric material in forming a mixture, wherein the antimicrobial agent comprises from about 0.05%> to about 5%> by weight of the mixture; and more preferably, from about 0.2%o to about 2%> by weight of the mixture. If the mixture further comprises a stabilizer, the stabilizer comprises about 0.01% to about 1%) by weight of the mixture.
  • antimicrobial agent is combined, in a predetermined amount corresponding to the desired antimicrobial activity, with the elastomeric material in a manner that the antimicrobial agent is incorporated into the spaces of the matrix of the elastomeric material comprising the septum that are normally present.
  • These reservoirs of antimicrobial agent serve to replenish antimicrobial agent that may be depleted at the septum surfaces. More particularly, the antimicrobial agent may migrate from these spaces and through the septum matrix until surface saturation and equilibrium is reached in providing a surface coating of antimicrobial agent that serves as a barrier to microbial contamination, and in continuously inhibiting microbial growth on the septum surface(s) durable over the useful life of the septum.
  • a septum- access port assembly or device 41 adapted to sealingly engage a tip
  • the septum-access port assembly comprising: an access port 43 comprising a housing, and a passageway extending entirely through the housing, wherein the passageway comprises a septum-receiving portion 45 that is generally oval, and an inwardly extending portion 47 that is tapered downwardly in direction toward an end of the access port opposite of the septum-receiving portion; an elastomeric septum comprising septum body 23, centrally-disposed curved surface 25 on at least one end of septum body 23, and a centrally located slit 27; wherein after the septum has been inserted into the access port in forming the septum-access port assembly, the access port compresses the centrally-disposed curved surface of the septum which (a) compresses the slit to be normally biased closed, and (b) allows for the slit to be openable and accessed under pressure of a tip in a process of inserting the tip through
  • the passageway comprises only the septum-receiving portion, and the elastomeric septum extends entirely through the access port so that surface 25b of the septum is in direct contact, and in fluid flow communication, with the chamber of the cell culture device (and contents therein, if any).
  • the septum is held in place inside and by contact with the access port housing by a friction fit.
  • the friction fit may further comprise a roughened or threaded surface of the access port housing which is contacted with the inserted septum to enhance the friction fit and to further minimize possible movement of the septum in the access port during use.
  • the access port housing compresses the septum in exerting pressure concentrated towards the center of the septum in enhancing the ability of the centrally located slit to sealingly engage a tip as well as enhancing the resealability of the septum.
  • the access port is tapered downward towards the inner end of the access port (i.e., the end opposite the septum-receiving portion). The taper in the access port helps direct an inserted tip toward the center of the passageway of the access port.
  • the taper may serve as a "stop" for the septum in preventing the septum to be pushed substantially farther into the passageway of the access port such as during the process of inserting a tip into the septum- access port assembly.
  • the taper may also create an additional force on the septum, as a tip is being inserted in the septum, which also compresses the slit to sealingly engage and close around the outer surface of the inserted tip.
  • the access port housing may further include one or more small notches 51 in the housing which is placed at the beginning of the taper as a further preventative measure in precluding the septum from moving further into the passageway of the access port such as from a force encountered when inserting a tip into the septum of a septum-access port assembly.
  • the access port housing is comprised of plastic or a synthetic resin, and more preferably comprised of polyethylene.
  • molded as part of the frame or housing of a cell culture device is the access port, and inserted therein is the septum in forming the septum-access port assembly.
  • the access port molded as part of the frame or housing of a cell culture device
  • the septum in forming the septum-access port assembly.
  • the outer curved surface 25a of the septum is generally flush with the adjacent surface of the frame of the device, and thus would be exposed to the environment outside of the cell culture device; whereas the inner end 46 of the access port would be the part of the passageway of the access port which would be in fluid flow communication with the chamber of the cell culture device (and contents therein, if any).
  • the septum-access port assembly may be used in a cell culture device to maintain a leak proof seal which serves as a barrier against contamination of the cell culture contents within the device, while allowing for fluid addition or fluid removal from the device while maintaining the contents as sterile.
  • the exterior surface of the septum is wiped with alcohol or other disinfectant or antimicrobial substance to remove or kill microorganisms from the external environment that may be present on the exterior surface of the septum, hi a preferred embodiment, the septum has an antimicrobial agent incorporated therein and which forms a surface coating (as previously described herein in more detail), thereby obviating the need to wipe the exterior surface of the septum with a disinfectant.
  • the slit of the septum- access port assembly is biased close.
  • a sterile tip is directed into the slit in penetrating the slit and forcing the slit open.
  • the slit septum is sufficiently elastomeric so as to permit the inserted tip to be slid easily therethrough while sealingly engaging and closing around the outer surface of the inserted tip. h one embodiment, the inserted tip may be inserted beyond the septum and into the tapered passageway of the access port.
  • the taper guides the tip to align with the passageway that accesses the chamber
  • the passageway comprises a septum-receiving portion and the septum extends to be in direct contact with the chamber
  • the inserted tip may be positioned either in the septum at a point close to the access to the chamber, or to extend part way into the chamber.
  • a fluid may be introduced into or withdrawn when in fluid flow communication with the chamber of the cell culture device.
  • the inserted tip is then retracted from the septum-access port assembly, and the septum causes the slit to reseal against the passage of microorganisms and the like, thus maintaining a leak-proof sterile seal.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Biochemistry (AREA)
  • Genetics & Genomics (AREA)
  • General Engineering & Computer Science (AREA)
  • Sustainable Development (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Molecular Biology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Apparatus Associated With Microorganisms And Enzymes (AREA)

Abstract

L'invention concerne un septum (21) qui a été fendu au préalable et qui peut être comprimé par un orifice d'accès d'un dispositif (41). Ledit septum est destiné à recevoir une pointe dans la fente (27) qui se referme de manière hermétique autour de la surface externe de la pointe insérée, assurant ainsi une étanchéité anti-fuite qui constitue une barrière à la contamination. Le septum élastomère comprend, de préférence, un agent antimicrobien qui permet d'inhiber la croissance microbienne sur les surfaces (25a & b) du septum. L'invention concerne également un ensemble (41) constituant l'orifice d'entrée du septum, conçu pour permettre l'insertion étanche d'une pointe, présentant un orifice d'entrée recevant et comprimant un septum élastomère (21), qui est retenu en place et comprimé par la partie recevant le septum d'orifice d'accès (45).
PCT/US2001/043724 2000-11-07 2001-11-06 Septum d'orifice d'acces et assemblage WO2002066595A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US70758800A 2000-11-07 2000-11-07
US09/707,588 2000-11-07
US71765100A 2000-11-21 2000-11-21
US09/717,651 2000-11-21

Publications (1)

Publication Number Publication Date
WO2002066595A1 true WO2002066595A1 (fr) 2002-08-29

Family

ID=27107910

Family Applications (2)

Application Number Title Priority Date Filing Date
PCT/US2001/030766 WO2002038460A1 (fr) 2000-11-07 2001-09-29 Septum d'orifice d'acces et assemblage
PCT/US2001/043724 WO2002066595A1 (fr) 2000-11-07 2001-11-06 Septum d'orifice d'acces et assemblage

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PCT/US2001/030766 WO2002038460A1 (fr) 2000-11-07 2001-09-29 Septum d'orifice d'acces et assemblage

Country Status (2)

Country Link
AU (1) AU2001294956A1 (fr)
WO (2) WO2002038460A1 (fr)

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005066328A1 (fr) 2003-12-31 2005-07-21 Corning Incorporated Flacon de culture cellulaire
WO2008014447A2 (fr) 2006-07-28 2008-01-31 Becton, Dickinson And Company Solutions et matériaux antimicrobiens pour dispositif d'accès vasculaire
DE102006023301A1 (de) * 2006-05-18 2008-02-28 Raumedic Ag Medizinisches Arbeitsmittel, medizinische Baugruppe mit einem derartigen Arbeitsmittel sowie Verwendung eines derartigen medizinischen Arbeitsmittels
FR2958170A1 (fr) * 2010-04-02 2011-10-07 Perouse Medical Necessaire d'injection d'un liquide dans un patient, comprenant une composition antimicrobienne.
EP2474607A1 (fr) 2005-07-26 2012-07-11 Corning Incorporated Appareil de culture cellulaire multicouche
WO2013048629A1 (fr) * 2011-09-30 2013-04-04 Covidien Lp Orifice d'accès intraveineux pré-percé
WO2016040852A1 (fr) * 2014-09-11 2016-03-17 Nabsys, Inc. Septum de pipette auto-étanche
US9309491B2 (en) 2007-05-29 2016-04-12 Corning Incorporated Cell culture apparatus for co-culture of cells
US9719980B2 (en) 2008-09-03 2017-08-01 Nabsys 2.0 Llc Devices and methods for determining the length of biopolymers and distances between probes bound thereto
US9914966B1 (en) 2012-12-20 2018-03-13 Nabsys 2.0 Llc Apparatus and methods for analysis of biomolecules using high frequency alternating current excitation
WO2018141783A1 (fr) 2017-01-31 2018-08-09 Schierholz Joerg Michael Embouts de cathéters en plastique contenant du phénoxyphénol polychloré (pcpp) en dispersion moléculaire
US10294516B2 (en) 2013-01-18 2019-05-21 Nabsys 2.0 Llc Enhanced probe binding
US10463845B2 (en) 2013-01-23 2019-11-05 C.R. Bard, Inc. Low-profile access port
USD870264S1 (en) 2017-09-06 2019-12-17 C. R. Bard, Inc. Implantable apheresis port
US11274341B2 (en) 2011-02-11 2022-03-15 NABsys, 2.0 LLC Assay methods using DNA binding proteins
US11420033B2 (en) 2013-01-23 2022-08-23 C. R. Bard, Inc. Low-profile single and dual vascular access device
US11464960B2 (en) 2013-01-23 2022-10-11 C. R. Bard, Inc. Low-profile single and dual vascular access device

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7229820B2 (en) 2002-06-13 2007-06-12 Wilson Wolf Manufacturing Corporation Apparatus and method for culturing and preserving tissue constructs
US7514256B2 (en) 2005-02-11 2009-04-07 Emilio Barbera-Guillem Bioreactor for selectively controlling the molecular diffusion between fluids

Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2546672A (en) * 1947-07-25 1951-03-27 Tecalemit Ltd Nipple or lubricant-receiving device
US3853127A (en) * 1973-04-03 1974-12-10 R Spademan Elastic sealing member
US4723950A (en) * 1984-12-12 1988-02-09 C. R. Bard, Inc. Urine drainage bag outlet with barrier against microbial infection
US5114400A (en) * 1990-06-19 1992-05-19 Lynn Lawrence A Blood withdrawal apparatus and method
US5163902A (en) * 1990-09-13 1992-11-17 James R. Longacre Patient fluid manifold
US5354275A (en) * 1993-09-13 1994-10-11 Minnesota Mining And Manufacturing Company Injection or sampling site
US5405331A (en) * 1992-07-29 1995-04-11 Minnesota Mining And Manufacturing Company IV injection site and system
US5785692A (en) * 1992-07-06 1998-07-28 Abbott Laboratories Safety cannula
US5833674A (en) * 1993-08-27 1998-11-10 St. Paul Medical, Inc. Needleless IV medical delivery system
US6171287B1 (en) * 1998-05-29 2001-01-09 Lawrence A. Lynn Luer receiver and method for fluid transfer

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5295658A (en) * 1987-04-27 1994-03-22 Vernay Laboratories, Inc. Medical coupling site including slit reinforcing members
US5964785A (en) * 1988-01-25 1999-10-12 Baxter International Inc. Bayonet look cannula for pre-slit y-site
DK0617634T3 (da) * 1991-12-10 2000-07-24 Abbott Lab Forbindelsesindretning med foropslidset tætning

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2546672A (en) * 1947-07-25 1951-03-27 Tecalemit Ltd Nipple or lubricant-receiving device
US3853127A (en) * 1973-04-03 1974-12-10 R Spademan Elastic sealing member
US4723950A (en) * 1984-12-12 1988-02-09 C. R. Bard, Inc. Urine drainage bag outlet with barrier against microbial infection
US5114400A (en) * 1990-06-19 1992-05-19 Lynn Lawrence A Blood withdrawal apparatus and method
US5163902A (en) * 1990-09-13 1992-11-17 James R. Longacre Patient fluid manifold
US5785692A (en) * 1992-07-06 1998-07-28 Abbott Laboratories Safety cannula
US5405331A (en) * 1992-07-29 1995-04-11 Minnesota Mining And Manufacturing Company IV injection site and system
US5833674A (en) * 1993-08-27 1998-11-10 St. Paul Medical, Inc. Needleless IV medical delivery system
US5354275A (en) * 1993-09-13 1994-10-11 Minnesota Mining And Manufacturing Company Injection or sampling site
US6171287B1 (en) * 1998-05-29 2001-01-09 Lawrence A. Lynn Luer receiver and method for fluid transfer

Cited By (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7078228B2 (en) 2003-12-31 2006-07-18 Corning Incorporated Cell cultivating flask
WO2005066328A1 (fr) 2003-12-31 2005-07-21 Corning Incorporated Flacon de culture cellulaire
US9040290B2 (en) 2005-07-26 2015-05-26 Corning Incorporated Multilayered cell culture apparatus
US11905506B2 (en) 2005-07-26 2024-02-20 Corning Incorporated Multilayered cell culture apparatus
US11274273B2 (en) 2005-07-26 2022-03-15 Corning Incorporated Multilayered cell culture apparatus
US9845451B2 (en) 2005-07-26 2017-12-19 Corning Incorporated Multilayered cell culture apparatus
EP2474607A1 (fr) 2005-07-26 2012-07-11 Corning Incorporated Appareil de culture cellulaire multicouche
US9290730B2 (en) 2005-07-26 2016-03-22 Corning Incorporated Multilayered cell culture apparatus
US8846399B2 (en) 2005-07-26 2014-09-30 Corning Incorporated Multilayered cell culture apparatus
US9045721B2 (en) 2005-07-26 2015-06-02 Corning Incorporated Multilayered cell culture apparatus
DE102006023301A1 (de) * 2006-05-18 2008-02-28 Raumedic Ag Medizinisches Arbeitsmittel, medizinische Baugruppe mit einem derartigen Arbeitsmittel sowie Verwendung eines derartigen medizinischen Arbeitsmittels
EP2046422A4 (fr) * 2006-07-28 2012-10-03 Becton Dickinson Co Solutions et matériaux antimicrobiens pour dispositif d'accès vasculaire
WO2008014447A2 (fr) 2006-07-28 2008-01-31 Becton, Dickinson And Company Solutions et matériaux antimicrobiens pour dispositif d'accès vasculaire
EP2046422A2 (fr) * 2006-07-28 2009-04-15 Becton, Dickinson and Company, Wagner, Jaconda Solutions et matériaux antimicrobiens pour dispositif d'accès vasculaire
US9309491B2 (en) 2007-05-29 2016-04-12 Corning Incorporated Cell culture apparatus for co-culture of cells
US9719980B2 (en) 2008-09-03 2017-08-01 Nabsys 2.0 Llc Devices and methods for determining the length of biopolymers and distances between probes bound thereto
FR2958170A1 (fr) * 2010-04-02 2011-10-07 Perouse Medical Necessaire d'injection d'un liquide dans un patient, comprenant une composition antimicrobienne.
US11274341B2 (en) 2011-02-11 2022-03-15 NABsys, 2.0 LLC Assay methods using DNA binding proteins
US9352138B2 (en) 2011-09-30 2016-05-31 Covidien Lp Pre-pierced IV access port
WO2013048629A1 (fr) * 2011-09-30 2013-04-04 Covidien Lp Orifice d'accès intraveineux pré-percé
US8945087B2 (en) 2011-09-30 2015-02-03 Covidien Lp Pre-pierced IV access port
US9914966B1 (en) 2012-12-20 2018-03-13 Nabsys 2.0 Llc Apparatus and methods for analysis of biomolecules using high frequency alternating current excitation
US10294516B2 (en) 2013-01-18 2019-05-21 Nabsys 2.0 Llc Enhanced probe binding
US11464960B2 (en) 2013-01-23 2022-10-11 C. R. Bard, Inc. Low-profile single and dual vascular access device
US10463845B2 (en) 2013-01-23 2019-11-05 C.R. Bard, Inc. Low-profile access port
US11420033B2 (en) 2013-01-23 2022-08-23 C. R. Bard, Inc. Low-profile single and dual vascular access device
US10583441B2 (en) 2014-09-11 2020-03-10 Nabsys 2.0 Llc Self-sealing pipette septum
WO2016040852A1 (fr) * 2014-09-11 2016-03-17 Nabsys, Inc. Septum de pipette auto-étanche
WO2018141783A1 (fr) 2017-01-31 2018-08-09 Schierholz Joerg Michael Embouts de cathéters en plastique contenant du phénoxyphénol polychloré (pcpp) en dispersion moléculaire
USD885557S1 (en) 2017-09-06 2020-05-26 C. R. Bard, Inc. Implantable apheresis port
USD870264S1 (en) 2017-09-06 2019-12-17 C. R. Bard, Inc. Implantable apheresis port

Also Published As

Publication number Publication date
AU2001294956A1 (en) 2002-05-21
WO2002038460A1 (fr) 2002-05-16

Similar Documents

Publication Publication Date Title
WO2002066595A1 (fr) Septum d'orifice d'acces et assemblage
US11752319B2 (en) IV access port cap for providing antimicrobial protection
CN107377492A (zh) 设备端口清洁器
DE69919262T2 (de) Universaler Stopfen
KR101911970B1 (ko) 제약 및/또는 영양상의 용도를 위한 액체 용액의 수집 및 분배용 장치를 위한, 바늘 없이 천공가능하며, 자동적으로 그리고 밀봉적으로 재 폐색 가능한 밀폐 커넥터
JP3694317B2 (ja) ポートアダプター及びプロテクター並びにこれらを有する容器
CA2495203C (fr) Orifice sans aiguille et procede de fabrication associe
US8641684B2 (en) Closure for tubular access port
EP0960616B1 (fr) Bouchon universel à utilisations multiples
US8480968B2 (en) Luer valve disinfectant swab-pouch
CA1134698A (fr) Event sterile
US6913580B2 (en) Method of body fluid specimen collection
US20080039803A1 (en) Luer protection pouch™ and luer valve/male luer protection method
US5328041A (en) Two piece stopper for blunt fluid connector
RU2015143861A (ru) Регулируемое неклассифицированное наполняющее устройство и способ
DE2824588A1 (de) Einweg-stopfen fuer vakuumroehrchen
DE2706337A1 (de) Verschlusstopfen fuer unterdruckbehaelter
GB2027168A (en) One-way valve assembly
CZ29095A3 (en) Closing device for little containers, particularly for medicaments, for providing access without need of needle
GB2050172A (en) Syringes
JP4802875B2 (ja) 細胞培養容器及び細胞移注方法
US4187149A (en) Cell culture sampling system
BR112014009409B1 (pt) Cartucho e sistema de coleta de sangue
EP2247274A1 (fr) Bouchon de fermeture pour récipients
AU2011362013A1 (en) Puncture free bottle cork and the application thereof

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ OM PH PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
REG Reference to national code

Ref country code: DE

Ref legal event code: 8642

122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP