Needleless connector
Inactive Publication Date: 2012-01-24
BAXTER INT INC
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- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Benefits of technology
[0037]There are other secondary objects, one or more if satisfied may promote market acceptance but satisfaction of each may not be necessary. One object of the present invention is to provide a needless connector fitting which may be actuated by a male luer tip without using a sharpened needle or an adapter s
Problems solved by technology
Replacement of catheters and sets is time consuming and expensive.
In addition, a connector may be exposed to negative pressure particularly when such connector is located upstream of an inlet of an intravenous pump.
Failure to prevent aspiration through a connector when the connector is exposed to negative pressure may lead to an aspiration of air and / or microbes into the fluid passageway.
Even a small number of failure is generally unacceptable when a single failure may put a patient or health care provider at risk.
As mentioned previously, although luer connectors are widely found in the medical environment such connections are generally not acceptable when many of the above described requirements need to be satisfied.
This is primarily due to the fact that the opening through the luer connector is not sealed so that upon disconnection the opening and the fluid passageway are open to the environment which would pose a health hazard to the patient.
Another factor which prevents use of luer connection assemblies in administration sets or injection sites is the inability for such a connector to seal against the pressurized fluid found within a set unless that connector is sealed or connected to a mating connector.
Although such connections possess many of the desired characteristics for sealed connections, the sharpened needles poses a needlestick hazard.
These needleless systems performed quite well; however, the septum can not be penetrated with a male luer tip and thus a blunt cannula is utilized having a diameter smaller than a male luer tip.
The requirement of the blunt cannula potentially increases the costs of using these types of connectors.
These connectors appear to all possess shortcomings which hinder widespread acceptance by medical practitioners.
In general, all of these devices perform in an inferior manner when measured relative to the desirable qualities for connector devices discussed above and also in comparison to the performance standards of a injection site for a sharpened needle and resilient septum or a blunt cannula and pre-slit resilient septum
Many or these boots stick in the collapsed position which leads to leaking.
In addition these moving parts present an interface between the movable boot and housing into which fluid may flow and collect and such collected fluids form a fertile environment for microbial growth, and recessed surfaces and gaps are hard to disinfect.
Moreover, the spikes act as flow restrictors and may impart severe turbulence to fluid as it flows through the openings in the spike.
Furthermore, after withdrawal of a male luer tip the boots may not recover quickly enough to seal the entrance through the connector and the fluid passageway may be briefly exposed to the environment.
However, the spike design has exhibited unsatisfactory leakage after a number of connects and disconnects which does not provide for extended use of a set or catheter.
In addition, these connectors have a multitude of parts which increases manufacturing costs and opportunities for malfunction.
Also the interface between the housing and boot is difficult to swab when the boot is in the uncompressed position.
However the septum appears not to be capable of sealing against the pressurized fluid found in a set.
Such a thread design may produce too rapid an increase in engaging force during the connection which may lead to a lock up of the luer lock to the connector.
Such a device suffers from several other drawbacks.
The valve includes a number of components to make up the housing, the environmental valve and check valve, and this high number of components increases manufacturing costs.
Such a thinned housing may fracture upon repeated connections and disconnects.
In addition the thickened axially extending portion of the septum forces the retainer to be thinned such that to presumably supply strength to the retainer the stated preferred material for the retainer is metal which increases manufacturing costs.
In addition it is believed that such valves will not exhibit satisfactory leak pressure after long periods of indwell, likely due to compression set of the septum material due to a perceived high level of compression of the septum material between the tip and retainer.
Method used
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first embodiment
[0069]Referring to FIG. 1, a connector device of the present invention is generally indicated at 10. The connector 10 generally provides multiple fluid connections with a penetrating member 12 (FIG. 2). In an example, the connector 10 may be attached to a conduit 14 in fluid communication with the human body. The conduit 14 may be a peripheral catheter 15, medical tubing or the like and forming a passageway 16 in fluid communication with the body for the flow of fluid to or from a body. The connector 10 may also be attached to other devices such as a vial or vial adapter (not shown) or the like or the connector may be used in lieu of open female luer fittings such as fittings on stopcocks.
[0070]Referring to FIG. 2, in an example, the penetrating member 12 is preferably a male luer slip or luer lock 13 conforming to ANSI or ISO standards; however, examples of other members, with appropriate modifications to the housing and septum, may include blunt cannula, needles, specially designe...
second embodiment
[0090]In an embodiment, the septum 28 is formed of a elastic, resilient material provided by the West Company of Lionville, Pa. It is anticipated that lubricating the septum 28 should facilitate insertion of the luer tip 18. Such lubrication may be applied while forming the slit or by other means such as incorporating the lubrication into the septum material or by applying lubricious coatings to the top surface. In a second embodiment, the septum 28 may be formed of a similar material, such as chlorinated polyisoprene produced by Lexington Medical of Rock Hill, S.C. In addition, the slit may be lubricated after assembly of the housing and septum using silicon oil produced by Dow Corning of Midland, Mich. The housing 26 is rigid and preferably formed of DN003 from Eastar of Kingsport, Tenn.
[0091]Although the housing 26 is shown as forming a luer connection 84 at a lower end, the housing may also be formed as a part of any device into which is it desirable to establish a sealed connec...
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A needless connector is provided which utilizes a resealable preslit septum valve. The valve is resiliently restrained relative to a housing with the valve and housing configured to accept a standard male luer lock having a luer tip which penetrates the valve through the opening to extend within the housing and a luer locking flange of the luer lock extending about the housing. The valve includes a disk shaped upper portion covering the opening, a lower portion spaced from the housing and extending downward from the disk shaped portion into a passageway defined by the housing, and an annular skirt to attach the septum to the housing. The connector exhibits satisfactory leak pressure after multiple connections and disconnects to the luer lock fitting and long periods of indwell of the luer tip.
Description
[0001]This application is a continuation of application Ser. No. 09 / 081728, filed May 20, 1998 now U.S. Pat. No. 5,957,898, issued Sep. 28, 1999, claims the benefit of U.S. Provisional Application No. 60 / 047,161, filed May 20, 1997.FIELD OF THE INVENTION[0002]The present invention relates generally to needleless fluid connection devices and more specifically to a device for repeatedly establishing a sealed connection to a conduit or a container for medical applications.BACKGROUND OF THE INVENTION[0003]One very prevalent form of health care therapy is infusion or intravenous (“I.V.”) therapy whereby fluids possessing desired medication or other characteristics are infused into a patient over varying lengths of time. To practice this infusion therapy frequently a connection needs to be made between components for the transfer of fluid between the two components, along a fluid passageway and eventually to a patient. As an example, administration sets are widely used to administer liqui...
Claims
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Patent Timeline
Login to View More IPC IPC(8): A61M5/00A61M5/14A61M39/02A61M39/04
CPCA61M39/045A61M2005/1404A61M2039/0036A61M2039/263Y10S128/912
InventorJEPSON, STEVEN C.DUDAR, THOMAS E.MONTANEZ, RODRIGO A.BINDOKAS, ALGIRDAS J.FINLEY, MICHAEL J.WHITE, JASON J.SUMMERS, CAMILLEDING, YUAN PANG SAMUELDANIELS, LEWIS E.
OwnerBAXTER INT INC