CA2158477A1 - Medical devices having antimicrobial properties and methods of making and using - Google Patents
Medical devices having antimicrobial properties and methods of making and usingInfo
- Publication number
- CA2158477A1 CA2158477A1 CA002158477A CA2158477A CA2158477A1 CA 2158477 A1 CA2158477 A1 CA 2158477A1 CA 002158477 A CA002158477 A CA 002158477A CA 2158477 A CA2158477 A CA 2158477A CA 2158477 A1 CA2158477 A1 CA 2158477A1
- Authority
- CA
- Canada
- Prior art keywords
- fluid
- access control
- control member
- antimicrobial agent
- fluid path
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/88—Draining devices having means for processing the drained fluid, e.g. an absorber
- A61M1/882—Draining devices provided with means for releasing antimicrobial or gelation agents in the drained fluid
-
- 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
- A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
- A61M39/162—Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
- A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/606—Coatings
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
- A61M39/10—Tube connectors; Tube couplings
- A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Vascular Medicine (AREA)
- Epidemiology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Surgery (AREA)
- Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Medicinal Chemistry (AREA)
- Pulmonology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Disposable medical devices having antimicrobial properties, systems incorporating such devices, and methods of making and using such devices are disclosed. Medical devices of the present invention, such as valves, injection sites, stopcocks, manifolds, dead-enders, movable and resilient plug bodies of the type used as the septums in sample site devices, etc., include a housing (12) having a fluid path (14) therein and at least one port (15) for coupling to a source of fluid. The device further includes an associated access control member (16) which communicates with the fluid path of the housing (12) to selectively control access thereto. The access control member may preferably comprise a synthetic resin material and an antimicrobial agent molded therein.
Description
~ W094/~522 2 1 5 8 ~ 7 7 PCT~S94/0~27 MEDICAL DEVICES HAVING ANTIMICROBIAL
PROPERTIES AND METHODS OF MAKING AND USING
FIELD OF THE INVENTION
This invention relates to disposable medical devices, and more particularly to medical devices having antimicrobial properties and methods of making and using such devices.
BACKGROUND OF THE INVENTION
There is increasingly heightened awareness in the medical community regarding contamination control and infection reduction, particularly in hospital environments. One of the primary sources of nosocomial (hospital related) infections stems from the use of medical devices and systems incorporating medical devices, such as fluid a~r;n;~tration sets and blood pressure monitoring sets, for example, in which fluids received by a patient (i.e., blood, plasma, saline, etc.) contact the devices and pick up infection-causing ba~teria.
Attempts have been made to address the problems of nosocomial infections by utilizing antimicrobial compositions in connection with various . c ., ~ ,.
types of medical devices. In particular, certain medical articles are known to have coatings of an antimicrobial-containing material thereon. Examples include catheters, tubing, drainage bags, etc. The following U.S. patents generally relate to medical devices of various types which include some form of antimicrobial composition: see U.S. Patent Nos.
3,987,007, 4,563,485, 4,581,028, 4,605,654, 4,054,139 and 4,483,688.
German Utility Model 9100743.7 describes a cannula with a socket which acts as an injection port for passage of fluid to a patient. When not in use the port can be sealed by a cap which carries a bung on the underside thereof. The bung is coated with an antimicrobial agent or is formed totally from such an agent or consists of an open-pore material with the agent deposited in the pores. The bung suppresses microbial growth in the injection port.
While it is known to utilize antimicrobial agents in connection with certain medical articles and devices, heretofore there has been no teaching or suggestion of medical devices having antimicrobial properties in accordance with the present invention and as described herein.
SUMMARY OF THE INVENTION
The present invention encompasses medical devices having antimicrobial properties, systems incorporating such devices, and methods of making and using such devices. The invention has particular Al\/IENDE~ ~;HE~T
IPE~/EP
21~8477 -2a-applicability to fluid administration sets and pressure monitoring sets, and the medical device components thereof which contact fluids that in turn contact patients. For example, the present invention contemplates a wide variety of medical devices, including valves, injection sites, stopcocks, manifolds, dead-enders, and both movable and AMEN~rD ~HE~T
IP~ /EP
~ W094/22522 215 8 q 7 7 PCT~S94/02327 resilient plug bodies, such as the septums in sample site devices.
In its broadest aspects, one embodiment of the invention is directed to medical devices which include a housing having a fluid path therein and at least one port for coupling to a source of fluid.
The device further includes a member associated with the housing which is in communication with the fluid path to selectively control access to the fluid path.
This member, referred to herein as an "access control member," has a composition comprising a synthetic resin material and an antimicrobial agent. Suitable synthetic resin materials include high density polyethylene (HDPE), polyurethane, polycarbonate, etc. With respect to the antimicrobial agent, it is known that certain metal ions such as silver, copper, zinc, and derivatives thereof, are "oligodynamic"; in other words, they exhibit antimicrobial activity, and thus can be utilized as the active component in the antimicrobial agent in devices of the present invention.
In one embodiment, the housings of medical devices according to the present invention have substantially no antimicrobial agent molded therein.
The access control member associated with the housing and which communicates with the fluid path does include an antimicrobial agent exposed on at least one surface which communicates with th~ fluid path in W094/22522 5 8 4~ ~ PCT~S94/0~27 the housing. Examples of suitable antimicrobial materials are glass microspheres, platelets or fibers coated with elemental silver. It will be appreciated by persons skilled in the art, however, that various other known antimicrobial materials can be utilized in the devices of the present invéntion. In a preferred embodiment, the access control member is comprised of synthetic resin in the range of about 75% to 99% by weight, and antimicrobial agent in the range of about 1% to 25% by weight.
In an alternative embodiment, the access control member of the device has an antimicrobial agent surface layer adhesively secured to a surface thereof which is in communication with the fluid path in the housing. In yet another alternative embodiment, the access control member of the medical device has an antimicrobial agent at least partially exposed on at least one surface thereof and which is applied thereto by ion beam implantation.
Another aspect of the present invention relates to methods of making medical device components which include a synthetic resin material and an antimicrobial agent. Methods according to this aspect of the invention preferably include the steps of (1) compounding a synthetic resin material and an antimicrobial agent to form a mixture; (2) molding the mixture to produce a medical device component (access control member); and (3) ablating ~ W094/22522 215 8 ~ 7 7 PCT~S94/02327 at least one surface of the component to at least partially expose the antimicrobial agent. The ablating step may comprise exposing the component or a specific desired surface thereof to an oxygen-containing plasma. This step is believed to remove small amounts of the resin material at the surface layer to expose the antimicrobial agent to a greater extent than may otherwise occur during the molding step.
Yet another aspect of the present invention is directed to methods of reducing the incidence of nosocomial infections in patients who are exposed to fluids susceptible of containing infection-causing bacteria. Methods according to this aspect of the invention comprise coupling the fluid into a housing having a fluid path therein and at least one port for coupling to a source of the fluid. Provided in association with the housing and in communication with the fluid path is an access control member for selectively controlling access to the fluid path.
The access control member is of the type described hereinabove and has a composition which includes a synthetic resin material and an effective amount of an antimicrobial agent to kill infection-causing bacteria in the fluid.
In a further aspect of the present invention, systems for adminstering fluid to patients are contemplated. Such systems include a fluid W094/22522 PCT~S94/0~27 2~5~4~ -6-source; a fluid conduit connected to the fluid source and adapted to be placed in fluidic communication with a patient; a housing having a fluid path and at least two ports for coupling the fluid path in series with the fluid conduit; and an access control member associated with the housing and in communication with the fluid path for selectively controlling access to the fluid path. The access control member has a composition comprising a synthetic resin material and an antimicrobial agent. The antimicrobial agent may be of any suitable type, particularly any of those described herein, and the access control member may be a valve, a dead end plug, a movable plug body, a resilient plug body, a syringe plunger, etc.
These and other features and advantages of the present invention will become apparent to persons skilled in the art upon review of the drawings taken in conjunction with the detailed description of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view, partially broken away, of a medical device (stopcock) according to one embodiment of the present invention;
Fig. 2A is a perspective view of two medical devices (stopcock and dead-ender) of the present invention coupled together;
~ W094l22522 215 8 4 7 7 PCT~S94/02327 Fig. 2B is a cross-sectional view of the dead-ender shown in Fig. 2A with a portion of the stopcock shown in phantom;
Fig. 3 is a cross-sectional view, partially broken away, of an alternative embodiment of a medical device (sample site) of the present inventlon;
Fig. 4 is a plan view, partially broken away and in partial cross-section, of another alternative embodiment (syringe with plunger) of the present invention;
Fig. 5 is a schematic representation of a fluid administration system according to the present invention;
Fig. 6A is a schematic representation, in cross-section, of an access control member of the present invention;
Fig. 6B shows the access control member of Fig. 6A subsequent to a surface treatment in accordance with the principles of the present invention;
Fig. 7 is a schematic representation, in cross-section, of an alternative embodiment of an access control member of the present invention; and Fig. 8 is a schematic representation, in 0 cross-section, of another alternative embodiment of an access control member of the present invention.
~S 8 -8- PCT~S94/0~27 DETAILED DESCRIPTION OF THE DRAWINGS
In accordance with general principles of the present invention, medical devices are contemplated which include a housing having a fluid path therein, at least one port for coupling to a source of fluid, and an access control member associated with the housing which is in communication with the fluid path for selectively controlling access to the fluid path. Figs. 1-4 show specific examples of medical device embodiments of the present invention. Fig. 5 is a schematic representation of a fluid A~ri ~; ctration system in accordance with the present invention and which incorporates medical devices of the present invention. Figs. 6A-8 are schematic representations of alternative embodiments of access control members.
With reference to Fig. 1, a stopcock 10 is shown which includes a housing 12 having a fluid path 14 therein and a plurality of ports 15 adapted to be coupled to a fluid source. Fluids which ~ay contain infection-causing bacteria and which contact a patient will flow through fluid path 14 during use of device 10. Stopcock 10 further includes an access control member such as valve 16 which is in communication with fluid path 14 and selectively controls access to the fluid path. Valve 16 is comprised of a synthetic resin material and an antimicrobial agent.
~W094l22522 215 8 ~ 7 7 PCT~S94/0~27 _9_ ~
With reference to Figs. 6A and B, there is shown alternative embodiments, in schematic form and in cross-section, of a portion designated generally as 20, of an access control member, which comprises a synthetic resin material designated generally as 22 and an antimicrobial agent molded therein designated generally as 24. A suitable antimicrobial agent, which will be described hereinbelow, is compounded with a synthetic resin material and molded to form the medical device component, such as the access control member (valve) 16 of Fig. 1. As shown in Fig. 6A, portion 20 has the antimicrobial agent 24 at least partially exposed at a surface 26 thereof. In accordance with further principles of the present invention, surface 26 may be subjected to a treatment, such as plasma etching, to remove resin 22 from the surface layer to thereby expose additional antimicrobial, as represented in schematic form in Fig. 6B. The new surface is designated 26'.
Suitable surface treatments for exposing additional antimicrobial agent will be described hereinafter.
Fig. 2A shows an alternative embodiment of a medical device of the present invention. More particularly, the device shown is a dead-ender 28 received in a port 30 of a stopcock lO. Fig. 2B
shows dead-ender 28 in cross-section, with port 30 of stopcock 10 shown in phantom. Dead-ender 28 comprises a synthetic resin material 22 having an WOg4/22522 PCT~S9410~27 2~5~ o-antimicrobial agent 24 dispersed therein. When dead-ender 28 is inserted into port 30 of stopcock 10, stem portion 32 engages port 30 in a friction fit and thus communicates with fluid path 14 to selectively control access to that fluid path.
Fig. 3 shows another alternative medical device in accordance with the principles of the present invention. Shown is a sample site or injection site device 34 which comprises a housing 36 having a fluid path 38 therein, and an access control member 40 which communicates with fluid path 38 to selectively control access to the fluid path. In this embodiment, access control member 40 may take the form of a resilient plug such as a rubber septum 42 having an antimicrobial agent 44 molded therein.
Alternatively, access control member 40 could be a valve such as seal member 38 shown and described in U.S. patent application Serial No. 07/855,147, filed March 20, 1992, the disclosure of which is fully incorporated herein ~y reference.
Yet another alternative medical device of the present invention is shown in Fig. 4. Syringe 46 has a housing 48 with a fluid path 50 therein.
Syringe 46 further includes a plunger 52 which is in communication with and selectively controls access to fluid path 50. Plunger 52 is preferably comprised of a synthetic resin material, such as rubber, having an antimicrobial agent molded therein, as shown.
W094l22522 PCT~S94/0~27 215~477 Fig. 7 shows, in schematic form, an alternative embodiment of a portion of an access control member for use in medical devices of the present invention. In this embodiment, access control member portion 60 has a layer 62 cont~;ning an antimicrobial agent 63 adhesively secured thereto along a surface 64. Antimicrobial-containing layer 62 is preferably secured to a surface 64 which is in communication with a fluid path in the medical device.
Fig. 8 is a schematic representation of an alternative access control member portion 66 in which a surface 68 thereof, which is to be in communication with a fluid path in a medical device, has an antimicrobial agent 70 implanted therein by ion beam implantation, as described in greater detail below.
Fig. 5 is a schematic representation of a blood pressure monitoring/blood sampling system 100.
The present invention is also intended to encompass although not specifically shown, systems such as fluid administration sets. System 100 shows a catheter 102 inserted into a patient 103 and connected by tubing 104 to a sample site device 34, which may be of the type shown in Fig. 3. Tubing 104 also connects sample site 34 to stopcock 10, which may be of the type shown herein in Fig. 1, and which may have a dead-ender 28, of the type shown in Figs.
2A and 2B, coupled thereto to close one of its outlet W094/~522 PCT~S94/0~27 ~
2i~ % 4~ ~ -12-ports. Tubing 104 is further connected to a source of saline 110. As is well known, saline source 110 may be pressurized by pressure infuser 112 and its associated squeeze bulb 114. Another stopcock 10 is included in the tubing line between squeeze bulb 114 and pressure infuser 112. During use, fluid samples may be withdrawn from system 100 via sample site 34 by means of a syringe 46, which may be of the type shown in Fig. 4.
There are a variety of suitable materials useful in the fabrication of devices and systems of the present invention. For example, in medical devices such as stopcocks, syringes, valves, manifolds, etc., the housing portion is typically molded polycarbonate~ which possesses desirable strength qualities while being transparent. Access control members utilized in stopcocks and dead-enders, as described herein, are preferably molded of high density polyethylene (HDPE). Other access control members, such as the resilient plugs in injection and sample site devices, are typically molded of elastomeric materials, such as latex. It will be appreciated by persons skilled in the art, however, that various other synthetic resin materials, or natural materials may be utilized in the practice of the present invention without departing from the scope thereof.
~W094/22522 21 5 8 ~ 7 7 PCT~S94/0~27 Various antimicrobial agents have been identified which may be used in the devices of the present invention. One such material is synthetic hydroxyapatite (HAP) in which some of the calcium atoms within the crystal structure are replaced with silver ions. One source of a suitable HAP is Sangi Group America (SGA), Los Angeles, CA, available under the trade name APACIDER-AW. Alternatively, silver-coated solid glass spheres may also be utilized as the antimicrobial agent. CONDUCT-O-FIL silver-coated glass microspheres, which have been found to be particularly useful in the practice of the present invention, are available from Potters Industries, Inc. of Parsippany, NJ, under the trade designations S-2429-S and S-5000-S2. It is believed that silver-coated glass platelets and fibers may also be successfully utilized; such materials are available from the PQ Corporation of Chattanooga, TN, under the trade names "AgClad Platelets" and "AgClad Filaments." While the specific materials identified above incorporate silver as the metal ion having antimicrobial properties, it will be appreciated that other metal ions such as copper and zinc, and derivatives thereof, may also possess suitable antimicrobial properties for use in medical devices according to the present invention.
The present invention further encompasses methods of making medical devices, and particularly W094/22522 PCT~S94/0~27 2 i~ 8 ~7 7 -14-the component parts thereof containing the antimicrobial material. In one embodiment, a synthetic resin such as high density polyethylene, in the range of about 75% to 99% by weight, is compounded with an antimicrobial agent in the range of about 1% to 25% by weight, an~d which may be any one of the above described materials, or any other suitable antimicrobial material, to form a mixture thereof. This mixture is subsequently molded, e.g., by injection molding, to form the desired medical device component. The components molded in this manner are typically the access control members used in the medical devices as described herein, since those members will contact the fluids containing infection-causing bacteria. The invention also contemplates, in an alternative embodiment, molding the housing portion of such medical devices with an antimicrobial additive, although under some circumstances doing so may deleteriously effect the physical properties of the housing. To be effective in killing infection-causing bacteria, it is necessary that the antimicrobial material be at least partially exposed on at least one surface of the medical device component which communicates with a fluid path in the device. It may be possible to promote migration of the antimicrobial additive to the surface of molded resin parts by utilizing lower injection pressures, lower injection speed and colder ~ W094/22522 21 S 8 ~ 7 7 PCT~S94/0~27 mold temperatures during the injection molding process.
It has been advantageously determined that increasing the exposure of antimicrobial agent in components of the present invention can be accomplished by ablating at least one surface of the component. One surface treatment which is particularly useful, and which itself is well known in the art, is a plasma ablation treatment in which the medical device component is exposed to an oxygen-containing plasma, and preferably an oxygen/carbon tetrafluoride (O2/CF4) plasma for approximately five minutes. The effect of such a plasma ablation treatment is represented in Figs. 6A and 6B, which show, respectively, an antimicrobial-containing resin component before and after the surface treatment. As shown in Fig. 6B, some of the resin material has been removed from surface 26 and thus a greater amount of the antimicrobial agent 24 is exposed at the new surface 26'.
In another alternative embodiment, shown in Fig. 7, the fluid-contacting surface or surfaces of an access control member used in a medical device of the present invention may have a coating of elemental silver adhesively secured thereto by means of a standard, hot stamp transfer procedure. In such procedures, a silver-cont~;n;ng coating or film 62 is created by standard tPrhn;~ues, i.e., laying down a W094/22522 ~7 ~ PCT~S94/0~27 thin film of elemental silver on a polyester film, followed by an adhesive, and this film 62 is subsequently transferred to the surface 64 of the access control member to whicAh~it is adhesively secured. `~
Alternatively, and as represented in Fig.
8, the surface 68 of a medical device component 66 which is to be in communication with a fluid path has a thin film 70 of an antimicrobial (e.g., elemental silver) deposited thereon by electron beam, DC or RF
sputtering. Furthermore, to improve the adhesion of the silver to the surface of elements made of low surface energy resins (i.e., polyolefins) ion beam implantation can be used following the thin film deposition to mix the deposited silver atoms into the surface. Ion beam enhanced deposition contemplates depositing the thin film of silver concurrent with ion beam bombardment. This approach optimizes adhesion of the silver to the surface. Thin film deposition, ion beam implantation, and ion beam enhanced deposition are all well known t~chn;ques for depositing and imp-anting thin metal films and ions onto exposed surfaces.
While the present invention has been il~ustrated by the description of embodiments thereof, and while the embodiments have been described in detail, it is not the intention of the inventors to restrict or in any way limit the scope ~ WO 94e2522 2 1 5 8 ~ 7 7 PCTNS941~2327 of the appended claims to ~uch detail. Additional advantages and modificatIo~s will readily appear to those skilled in the art. It will be understood that the specific medical device examples described herein are exemplary only, and additional medical devices not specifically described can be produced in accordance with the principles of the present invention to incorporate antimicrobial properties therein. The invention in its broader aspects is lo therefore not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described.
Accordingly, departures may be made from such details without departing from the spirit or scope of the inventors' general inventive concept.
What is claimed is:
PROPERTIES AND METHODS OF MAKING AND USING
FIELD OF THE INVENTION
This invention relates to disposable medical devices, and more particularly to medical devices having antimicrobial properties and methods of making and using such devices.
BACKGROUND OF THE INVENTION
There is increasingly heightened awareness in the medical community regarding contamination control and infection reduction, particularly in hospital environments. One of the primary sources of nosocomial (hospital related) infections stems from the use of medical devices and systems incorporating medical devices, such as fluid a~r;n;~tration sets and blood pressure monitoring sets, for example, in which fluids received by a patient (i.e., blood, plasma, saline, etc.) contact the devices and pick up infection-causing ba~teria.
Attempts have been made to address the problems of nosocomial infections by utilizing antimicrobial compositions in connection with various . c ., ~ ,.
types of medical devices. In particular, certain medical articles are known to have coatings of an antimicrobial-containing material thereon. Examples include catheters, tubing, drainage bags, etc. The following U.S. patents generally relate to medical devices of various types which include some form of antimicrobial composition: see U.S. Patent Nos.
3,987,007, 4,563,485, 4,581,028, 4,605,654, 4,054,139 and 4,483,688.
German Utility Model 9100743.7 describes a cannula with a socket which acts as an injection port for passage of fluid to a patient. When not in use the port can be sealed by a cap which carries a bung on the underside thereof. The bung is coated with an antimicrobial agent or is formed totally from such an agent or consists of an open-pore material with the agent deposited in the pores. The bung suppresses microbial growth in the injection port.
While it is known to utilize antimicrobial agents in connection with certain medical articles and devices, heretofore there has been no teaching or suggestion of medical devices having antimicrobial properties in accordance with the present invention and as described herein.
SUMMARY OF THE INVENTION
The present invention encompasses medical devices having antimicrobial properties, systems incorporating such devices, and methods of making and using such devices. The invention has particular Al\/IENDE~ ~;HE~T
IPE~/EP
21~8477 -2a-applicability to fluid administration sets and pressure monitoring sets, and the medical device components thereof which contact fluids that in turn contact patients. For example, the present invention contemplates a wide variety of medical devices, including valves, injection sites, stopcocks, manifolds, dead-enders, and both movable and AMEN~rD ~HE~T
IP~ /EP
~ W094/22522 215 8 q 7 7 PCT~S94/02327 resilient plug bodies, such as the septums in sample site devices.
In its broadest aspects, one embodiment of the invention is directed to medical devices which include a housing having a fluid path therein and at least one port for coupling to a source of fluid.
The device further includes a member associated with the housing which is in communication with the fluid path to selectively control access to the fluid path.
This member, referred to herein as an "access control member," has a composition comprising a synthetic resin material and an antimicrobial agent. Suitable synthetic resin materials include high density polyethylene (HDPE), polyurethane, polycarbonate, etc. With respect to the antimicrobial agent, it is known that certain metal ions such as silver, copper, zinc, and derivatives thereof, are "oligodynamic"; in other words, they exhibit antimicrobial activity, and thus can be utilized as the active component in the antimicrobial agent in devices of the present invention.
In one embodiment, the housings of medical devices according to the present invention have substantially no antimicrobial agent molded therein.
The access control member associated with the housing and which communicates with the fluid path does include an antimicrobial agent exposed on at least one surface which communicates with th~ fluid path in W094/22522 5 8 4~ ~ PCT~S94/0~27 the housing. Examples of suitable antimicrobial materials are glass microspheres, platelets or fibers coated with elemental silver. It will be appreciated by persons skilled in the art, however, that various other known antimicrobial materials can be utilized in the devices of the present invéntion. In a preferred embodiment, the access control member is comprised of synthetic resin in the range of about 75% to 99% by weight, and antimicrobial agent in the range of about 1% to 25% by weight.
In an alternative embodiment, the access control member of the device has an antimicrobial agent surface layer adhesively secured to a surface thereof which is in communication with the fluid path in the housing. In yet another alternative embodiment, the access control member of the medical device has an antimicrobial agent at least partially exposed on at least one surface thereof and which is applied thereto by ion beam implantation.
Another aspect of the present invention relates to methods of making medical device components which include a synthetic resin material and an antimicrobial agent. Methods according to this aspect of the invention preferably include the steps of (1) compounding a synthetic resin material and an antimicrobial agent to form a mixture; (2) molding the mixture to produce a medical device component (access control member); and (3) ablating ~ W094/22522 215 8 ~ 7 7 PCT~S94/02327 at least one surface of the component to at least partially expose the antimicrobial agent. The ablating step may comprise exposing the component or a specific desired surface thereof to an oxygen-containing plasma. This step is believed to remove small amounts of the resin material at the surface layer to expose the antimicrobial agent to a greater extent than may otherwise occur during the molding step.
Yet another aspect of the present invention is directed to methods of reducing the incidence of nosocomial infections in patients who are exposed to fluids susceptible of containing infection-causing bacteria. Methods according to this aspect of the invention comprise coupling the fluid into a housing having a fluid path therein and at least one port for coupling to a source of the fluid. Provided in association with the housing and in communication with the fluid path is an access control member for selectively controlling access to the fluid path.
The access control member is of the type described hereinabove and has a composition which includes a synthetic resin material and an effective amount of an antimicrobial agent to kill infection-causing bacteria in the fluid.
In a further aspect of the present invention, systems for adminstering fluid to patients are contemplated. Such systems include a fluid W094/22522 PCT~S94/0~27 2~5~4~ -6-source; a fluid conduit connected to the fluid source and adapted to be placed in fluidic communication with a patient; a housing having a fluid path and at least two ports for coupling the fluid path in series with the fluid conduit; and an access control member associated with the housing and in communication with the fluid path for selectively controlling access to the fluid path. The access control member has a composition comprising a synthetic resin material and an antimicrobial agent. The antimicrobial agent may be of any suitable type, particularly any of those described herein, and the access control member may be a valve, a dead end plug, a movable plug body, a resilient plug body, a syringe plunger, etc.
These and other features and advantages of the present invention will become apparent to persons skilled in the art upon review of the drawings taken in conjunction with the detailed description of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view, partially broken away, of a medical device (stopcock) according to one embodiment of the present invention;
Fig. 2A is a perspective view of two medical devices (stopcock and dead-ender) of the present invention coupled together;
~ W094l22522 215 8 4 7 7 PCT~S94/02327 Fig. 2B is a cross-sectional view of the dead-ender shown in Fig. 2A with a portion of the stopcock shown in phantom;
Fig. 3 is a cross-sectional view, partially broken away, of an alternative embodiment of a medical device (sample site) of the present inventlon;
Fig. 4 is a plan view, partially broken away and in partial cross-section, of another alternative embodiment (syringe with plunger) of the present invention;
Fig. 5 is a schematic representation of a fluid administration system according to the present invention;
Fig. 6A is a schematic representation, in cross-section, of an access control member of the present invention;
Fig. 6B shows the access control member of Fig. 6A subsequent to a surface treatment in accordance with the principles of the present invention;
Fig. 7 is a schematic representation, in cross-section, of an alternative embodiment of an access control member of the present invention; and Fig. 8 is a schematic representation, in 0 cross-section, of another alternative embodiment of an access control member of the present invention.
~S 8 -8- PCT~S94/0~27 DETAILED DESCRIPTION OF THE DRAWINGS
In accordance with general principles of the present invention, medical devices are contemplated which include a housing having a fluid path therein, at least one port for coupling to a source of fluid, and an access control member associated with the housing which is in communication with the fluid path for selectively controlling access to the fluid path. Figs. 1-4 show specific examples of medical device embodiments of the present invention. Fig. 5 is a schematic representation of a fluid A~ri ~; ctration system in accordance with the present invention and which incorporates medical devices of the present invention. Figs. 6A-8 are schematic representations of alternative embodiments of access control members.
With reference to Fig. 1, a stopcock 10 is shown which includes a housing 12 having a fluid path 14 therein and a plurality of ports 15 adapted to be coupled to a fluid source. Fluids which ~ay contain infection-causing bacteria and which contact a patient will flow through fluid path 14 during use of device 10. Stopcock 10 further includes an access control member such as valve 16 which is in communication with fluid path 14 and selectively controls access to the fluid path. Valve 16 is comprised of a synthetic resin material and an antimicrobial agent.
~W094l22522 215 8 ~ 7 7 PCT~S94/0~27 _9_ ~
With reference to Figs. 6A and B, there is shown alternative embodiments, in schematic form and in cross-section, of a portion designated generally as 20, of an access control member, which comprises a synthetic resin material designated generally as 22 and an antimicrobial agent molded therein designated generally as 24. A suitable antimicrobial agent, which will be described hereinbelow, is compounded with a synthetic resin material and molded to form the medical device component, such as the access control member (valve) 16 of Fig. 1. As shown in Fig. 6A, portion 20 has the antimicrobial agent 24 at least partially exposed at a surface 26 thereof. In accordance with further principles of the present invention, surface 26 may be subjected to a treatment, such as plasma etching, to remove resin 22 from the surface layer to thereby expose additional antimicrobial, as represented in schematic form in Fig. 6B. The new surface is designated 26'.
Suitable surface treatments for exposing additional antimicrobial agent will be described hereinafter.
Fig. 2A shows an alternative embodiment of a medical device of the present invention. More particularly, the device shown is a dead-ender 28 received in a port 30 of a stopcock lO. Fig. 2B
shows dead-ender 28 in cross-section, with port 30 of stopcock 10 shown in phantom. Dead-ender 28 comprises a synthetic resin material 22 having an WOg4/22522 PCT~S9410~27 2~5~ o-antimicrobial agent 24 dispersed therein. When dead-ender 28 is inserted into port 30 of stopcock 10, stem portion 32 engages port 30 in a friction fit and thus communicates with fluid path 14 to selectively control access to that fluid path.
Fig. 3 shows another alternative medical device in accordance with the principles of the present invention. Shown is a sample site or injection site device 34 which comprises a housing 36 having a fluid path 38 therein, and an access control member 40 which communicates with fluid path 38 to selectively control access to the fluid path. In this embodiment, access control member 40 may take the form of a resilient plug such as a rubber septum 42 having an antimicrobial agent 44 molded therein.
Alternatively, access control member 40 could be a valve such as seal member 38 shown and described in U.S. patent application Serial No. 07/855,147, filed March 20, 1992, the disclosure of which is fully incorporated herein ~y reference.
Yet another alternative medical device of the present invention is shown in Fig. 4. Syringe 46 has a housing 48 with a fluid path 50 therein.
Syringe 46 further includes a plunger 52 which is in communication with and selectively controls access to fluid path 50. Plunger 52 is preferably comprised of a synthetic resin material, such as rubber, having an antimicrobial agent molded therein, as shown.
W094l22522 PCT~S94/0~27 215~477 Fig. 7 shows, in schematic form, an alternative embodiment of a portion of an access control member for use in medical devices of the present invention. In this embodiment, access control member portion 60 has a layer 62 cont~;ning an antimicrobial agent 63 adhesively secured thereto along a surface 64. Antimicrobial-containing layer 62 is preferably secured to a surface 64 which is in communication with a fluid path in the medical device.
Fig. 8 is a schematic representation of an alternative access control member portion 66 in which a surface 68 thereof, which is to be in communication with a fluid path in a medical device, has an antimicrobial agent 70 implanted therein by ion beam implantation, as described in greater detail below.
Fig. 5 is a schematic representation of a blood pressure monitoring/blood sampling system 100.
The present invention is also intended to encompass although not specifically shown, systems such as fluid administration sets. System 100 shows a catheter 102 inserted into a patient 103 and connected by tubing 104 to a sample site device 34, which may be of the type shown in Fig. 3. Tubing 104 also connects sample site 34 to stopcock 10, which may be of the type shown herein in Fig. 1, and which may have a dead-ender 28, of the type shown in Figs.
2A and 2B, coupled thereto to close one of its outlet W094/~522 PCT~S94/0~27 ~
2i~ % 4~ ~ -12-ports. Tubing 104 is further connected to a source of saline 110. As is well known, saline source 110 may be pressurized by pressure infuser 112 and its associated squeeze bulb 114. Another stopcock 10 is included in the tubing line between squeeze bulb 114 and pressure infuser 112. During use, fluid samples may be withdrawn from system 100 via sample site 34 by means of a syringe 46, which may be of the type shown in Fig. 4.
There are a variety of suitable materials useful in the fabrication of devices and systems of the present invention. For example, in medical devices such as stopcocks, syringes, valves, manifolds, etc., the housing portion is typically molded polycarbonate~ which possesses desirable strength qualities while being transparent. Access control members utilized in stopcocks and dead-enders, as described herein, are preferably molded of high density polyethylene (HDPE). Other access control members, such as the resilient plugs in injection and sample site devices, are typically molded of elastomeric materials, such as latex. It will be appreciated by persons skilled in the art, however, that various other synthetic resin materials, or natural materials may be utilized in the practice of the present invention without departing from the scope thereof.
~W094/22522 21 5 8 ~ 7 7 PCT~S94/0~27 Various antimicrobial agents have been identified which may be used in the devices of the present invention. One such material is synthetic hydroxyapatite (HAP) in which some of the calcium atoms within the crystal structure are replaced with silver ions. One source of a suitable HAP is Sangi Group America (SGA), Los Angeles, CA, available under the trade name APACIDER-AW. Alternatively, silver-coated solid glass spheres may also be utilized as the antimicrobial agent. CONDUCT-O-FIL silver-coated glass microspheres, which have been found to be particularly useful in the practice of the present invention, are available from Potters Industries, Inc. of Parsippany, NJ, under the trade designations S-2429-S and S-5000-S2. It is believed that silver-coated glass platelets and fibers may also be successfully utilized; such materials are available from the PQ Corporation of Chattanooga, TN, under the trade names "AgClad Platelets" and "AgClad Filaments." While the specific materials identified above incorporate silver as the metal ion having antimicrobial properties, it will be appreciated that other metal ions such as copper and zinc, and derivatives thereof, may also possess suitable antimicrobial properties for use in medical devices according to the present invention.
The present invention further encompasses methods of making medical devices, and particularly W094/22522 PCT~S94/0~27 2 i~ 8 ~7 7 -14-the component parts thereof containing the antimicrobial material. In one embodiment, a synthetic resin such as high density polyethylene, in the range of about 75% to 99% by weight, is compounded with an antimicrobial agent in the range of about 1% to 25% by weight, an~d which may be any one of the above described materials, or any other suitable antimicrobial material, to form a mixture thereof. This mixture is subsequently molded, e.g., by injection molding, to form the desired medical device component. The components molded in this manner are typically the access control members used in the medical devices as described herein, since those members will contact the fluids containing infection-causing bacteria. The invention also contemplates, in an alternative embodiment, molding the housing portion of such medical devices with an antimicrobial additive, although under some circumstances doing so may deleteriously effect the physical properties of the housing. To be effective in killing infection-causing bacteria, it is necessary that the antimicrobial material be at least partially exposed on at least one surface of the medical device component which communicates with a fluid path in the device. It may be possible to promote migration of the antimicrobial additive to the surface of molded resin parts by utilizing lower injection pressures, lower injection speed and colder ~ W094/22522 21 S 8 ~ 7 7 PCT~S94/0~27 mold temperatures during the injection molding process.
It has been advantageously determined that increasing the exposure of antimicrobial agent in components of the present invention can be accomplished by ablating at least one surface of the component. One surface treatment which is particularly useful, and which itself is well known in the art, is a plasma ablation treatment in which the medical device component is exposed to an oxygen-containing plasma, and preferably an oxygen/carbon tetrafluoride (O2/CF4) plasma for approximately five minutes. The effect of such a plasma ablation treatment is represented in Figs. 6A and 6B, which show, respectively, an antimicrobial-containing resin component before and after the surface treatment. As shown in Fig. 6B, some of the resin material has been removed from surface 26 and thus a greater amount of the antimicrobial agent 24 is exposed at the new surface 26'.
In another alternative embodiment, shown in Fig. 7, the fluid-contacting surface or surfaces of an access control member used in a medical device of the present invention may have a coating of elemental silver adhesively secured thereto by means of a standard, hot stamp transfer procedure. In such procedures, a silver-cont~;n;ng coating or film 62 is created by standard tPrhn;~ues, i.e., laying down a W094/22522 ~7 ~ PCT~S94/0~27 thin film of elemental silver on a polyester film, followed by an adhesive, and this film 62 is subsequently transferred to the surface 64 of the access control member to whicAh~it is adhesively secured. `~
Alternatively, and as represented in Fig.
8, the surface 68 of a medical device component 66 which is to be in communication with a fluid path has a thin film 70 of an antimicrobial (e.g., elemental silver) deposited thereon by electron beam, DC or RF
sputtering. Furthermore, to improve the adhesion of the silver to the surface of elements made of low surface energy resins (i.e., polyolefins) ion beam implantation can be used following the thin film deposition to mix the deposited silver atoms into the surface. Ion beam enhanced deposition contemplates depositing the thin film of silver concurrent with ion beam bombardment. This approach optimizes adhesion of the silver to the surface. Thin film deposition, ion beam implantation, and ion beam enhanced deposition are all well known t~chn;ques for depositing and imp-anting thin metal films and ions onto exposed surfaces.
While the present invention has been il~ustrated by the description of embodiments thereof, and while the embodiments have been described in detail, it is not the intention of the inventors to restrict or in any way limit the scope ~ WO 94e2522 2 1 5 8 ~ 7 7 PCTNS941~2327 of the appended claims to ~uch detail. Additional advantages and modificatIo~s will readily appear to those skilled in the art. It will be understood that the specific medical device examples described herein are exemplary only, and additional medical devices not specifically described can be produced in accordance with the principles of the present invention to incorporate antimicrobial properties therein. The invention in its broader aspects is lo therefore not limited to the specific details, representative apparatus and methods, and illustrative examples shown and described.
Accordingly, departures may be made from such details without departing from the spirit or scope of the inventors' general inventive concept.
What is claimed is:
Claims (23)
1. A medical device comprising a housing having a fluid path therein and at least one port for coupling to a source of fluid, and a fluid access control member associated with the housing and in communication with the fluid path to selectively control fluid access to the fluid path, characterized in that the fluid access control member has a composition comprising a synthetic resin material and an antimicrobial agent and in that the antimicrobial agent is compounded with the synthetic resin material and molded to form the fluid access control member.
2. A device as claimed in Claim 1 wherein the antimicrobial agent is at least partially exposed on at least one surface of the access control member.
3. A device as claimed in Claim 2 wherein the access control member has at least one ablated surface to at least partially expose the antimicrobial agent.
4. A device as claimed in any preceding Claim wherein the access control member comprises in the range of 75% to 99% by weight synthetic resin material and 1% to 25% by weight antimicrobial agent.
5. A device as claimed in Claim 4 wherein the access control member comprises about 75% by weight synthetic resin material and about 25% by weight antimicrobial agent.
6. A device as claimed in Claim 1 wherein the antimicrobial agent comprises glass microspheres coated with e?emental silver or glass platelets coated with silver or glass fibers coated with silver.
7. A medical device comprising a housing having a fluid path therein and at least one port for coupling to a source of fluid, and a fluid access control member associated with the housing and in communication with the fluid path to selectively control access to the fluid path, the access control member comprising a synthetic resin material with a layer of an antimicrobial agent on at least one surface thereof which is in communication with the fluid path, characterized in that the layer of antimicrobial agent is adhesively secured to the surface.
8. A medical device comprising a housing having a fluid path therein and at least one port for coupling to a source of fluid, and a fluid access control member associated with the housing and in communication with the fluid path to selectively control fluid access to the fluid path, characterized in that the fluid access control member has a composition comprising a synthetic resin material and an antimicrobial agent and in that the antimicrobial agent is exposed on at least one surface of the access control member and applied thereto by ion beam implantation.
9. A device as claimed in any one of Claims 1 to 5, 7 or 8 wherein the antimicrobial agent has as an active ingredient a metal selected from the group consisting of silver, copper, zinc, and derivatives thereof.
10. A device as claimed in any one of Claims 1 to 5, 7 or 8 wherein the antimicrobial agent has as an active ingredient silver or a derivative thereof.
11. A device as claimed in any preceding Claim wherein the synthetic resin material includes polyethylene.
12. A device as claimed in any preceding Claim wherein the housing is comprised substantially of a synthetic resin material.
13. A device as claimed in Claim 12 wherein the synthetic resin material including polycarbonate.
14. A device as claimed in any preceding Claim, the housing being substantially devoid of an antimicrobial agent.
15. A device as claimed in any preceding Claim further comprising a second port, the access control member being a valve situated between the first and second ports and operable to selectively control fluid communication between the second port and the fluid path.
16. A device as claimed in any one of Claims 1 to 14 further comprising a second port, the access control member being a dead-end plug receivable in the second port to seal same.
17. A device as claimed in any one of Claims 1 to 14 further comprising a second port communicating with the fluid path, the access control member being a moveable plug body in the second port.
18. A device as claimed in any one of Claims 1 to 14 further comprising a second port communicating with the fluid path, the access control member being a resilient plug body in the second port.
19. A device as claimed in any one of Claims 1 to 14, the housing including a syringe body and the access control member being a syringe plunger moveable within the syringe body.
20. A system for the administration of fluid to a patient comprising a fluid source, a fluid conduit connected to the fluid source and adapted to be placed in fluidic communication with a patient, and a device as claimed in any one of Claims 1 to 14 wherein the housing has at least two ports for coupling the fluid path in series with the fluid conduit.
21. A method of making a medical device component including a synthetic resin material and an antimicrobial agent comprising compounding a synthetic resin material and an antimicrobial agent to form a mixture thereof, characterized in that the method includes molding the mixture to produce a medical device component and ablating at least one surface of the component to at least partially expose the antimicrobial agent.
22. A method as claimed in Claim 21 wherein the ablating step comprises exposing the at least one surface to an oxygen-containing plasma.
23. A method as claimed in Claim 22, the plasma ablating step having a duration of about 5 minutes.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US3991693A | 1993-03-30 | 1993-03-30 | |
| US039,916 | 1993-03-30 |
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| CA2158477A1 true CA2158477A1 (en) | 1994-10-13 |
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Family Applications (1)
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|---|---|---|---|
| CA002158477A Abandoned CA2158477A1 (en) | 1993-03-30 | 1994-03-03 | Medical devices having antimicrobial properties and methods of making and using |
Country Status (5)
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| EP (1) | EP0691869A1 (en) |
| JP (1) | JPH08508421A (en) |
| AU (1) | AU6443394A (en) |
| CA (1) | CA2158477A1 (en) |
| WO (1) | WO1994022522A1 (en) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6706022B1 (en) * | 1999-07-27 | 2004-03-16 | Alaris Medical Systems, Inc. | Needleless medical connector with expandable valve mechanism |
| US7160272B1 (en) | 2002-05-31 | 2007-01-09 | Elcam Plastic | Y-site medical valve |
| US7771383B2 (en) | 2004-10-22 | 2010-08-10 | Medegen, Inc. | Fluid control device with valve and methods of use |
| DE202009013408U1 (en) * | 2009-10-23 | 2011-03-03 | Hopf, Hans-Jürgen | Multi-way tap with antiseptic or antimicrobial surfaces |
| US10426943B2 (en) | 2011-08-11 | 2019-10-01 | Attwill Medical Solutions Sterilflow L.P. | Insert for luer connection |
| US9375561B2 (en) | 2011-09-02 | 2016-06-28 | Carefusion 303, Inc. | Self-flushing valve |
| WO2013115728A1 (en) * | 2012-02-02 | 2013-08-08 | Becton Dickinson Holdings Pte. Ltd. | Adaptor for coupling with a medical container |
| US9695323B2 (en) | 2013-02-13 | 2017-07-04 | Becton, Dickinson And Company | UV curable solventless antimicrobial compositions |
| US9750928B2 (en) | 2013-02-13 | 2017-09-05 | Becton, Dickinson And Company | Blood control IV catheter with stationary septum activator |
| US10792398B2 (en) * | 2014-02-20 | 2020-10-06 | Becton, Dickinson And Company | Antimicrobial inserts for medical devices |
| US10792399B2 (en) | 2014-02-20 | 2020-10-06 | Becton, Dickinson And Company | Antimicrobial inserts for medical devices |
| US9789279B2 (en) | 2014-04-23 | 2017-10-17 | Becton, Dickinson And Company | Antimicrobial obturator for use with vascular access devices |
| US10149971B2 (en) * | 2014-04-23 | 2018-12-11 | Becton, Dickinson And Company | Antimicrobial stopcock medical connector |
| US10376686B2 (en) | 2014-04-23 | 2019-08-13 | Becton, Dickinson And Company | Antimicrobial caps for medical connectors |
| US9675793B2 (en) | 2014-04-23 | 2017-06-13 | Becton, Dickinson And Company | Catheter tubing with extraluminal antimicrobial coating |
| EP3145560A4 (en) | 2014-05-21 | 2018-01-17 | Attwill Medical Solutions Steriflow L.P. | Insert for catheter system |
| US10232088B2 (en) | 2014-07-08 | 2019-03-19 | Becton, Dickinson And Company | Antimicrobial coating forming kink resistant feature on a vascular access device |
| US10004890B2 (en) * | 2015-01-27 | 2018-06-26 | Becton, Dickinson And Company | Antimicrobial inserts for stopcock medical connectors |
| ES2926678T3 (en) | 2015-03-30 | 2022-10-27 | Bard Inc C R | Application of antimicrobial agents to medical devices |
| ES2671844B1 (en) | 2015-06-11 | 2019-03-22 | Attwill Medical Solutions Inc | Medical devices, systems and methods that use anti-thrombin heparin compositions. |
| US10493244B2 (en) | 2015-10-28 | 2019-12-03 | Becton, Dickinson And Company | Extension tubing strain relief |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4054139A (en) * | 1975-11-20 | 1977-10-18 | Crossley Kent B | Oligodynamic catheter |
| US4483688A (en) * | 1980-09-22 | 1984-11-20 | Hiroshi Akiyama | Catheter |
| US4469835A (en) * | 1981-06-05 | 1984-09-04 | Baxter Travenol Laboratories, Inc. | Connector member adapted for ultraviolet antimicrobial irradiation |
| GB8720502D0 (en) * | 1987-08-29 | 1987-10-07 | Giltech Ltd | Antimicrobial composition |
| US5180365A (en) * | 1990-03-01 | 1993-01-19 | Ensminger William D | Implantable infusion device |
| DE9100743U1 (en) * | 1991-01-23 | 1991-04-11 | Vygon GmbH & Co KG, 5100 Aachen | Intravenous cannula |
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1994
- 1994-03-03 WO PCT/US1994/002327 patent/WO1994022522A1/en not_active Application Discontinuation
- 1994-03-03 JP JP6522068A patent/JPH08508421A/en not_active Ceased
- 1994-03-03 CA CA002158477A patent/CA2158477A1/en not_active Abandoned
- 1994-03-03 AU AU64433/94A patent/AU6443394A/en not_active Abandoned
- 1994-03-03 EP EP94912179A patent/EP0691869A1/en not_active Withdrawn
Also Published As
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| AU6443394A (en) | 1994-10-24 |
| EP0691869A1 (en) | 1996-01-17 |
| JPH08508421A (en) | 1996-09-10 |
| WO1994022522A1 (en) | 1994-10-13 |
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