The present disclosure relates to safety connectors for use in medical applications, particularly for use with compression therapy devices. The present disclosure also relates to discriminating safety connector assemblies and, more particularly, to a discriminating safety connector assembly for fluidly coupling at least two lumens capable of forming a non-leaking fluid circuit.
In a medical environment, many devices have tubing adapted for manual connection in order to provide a fluid connection between devices or between a device and a patient including enteral feeding pumps and intravenous feeding lines. Each of these devices includes one or more connectors that a user or practitioner may inadvertently connect together. This may result in the successful connection of incompatible devices or the supply of fluid or nutrient to an improper intravenous line or a device such as an inflatable bladder used in deep vein thrombosis therapy. Successful connection of incompatible devices may harm patients or damage equipment.
When connecting a medical device to a fluid supply, a non-leaking seal must be made between compatible devices and/or fluid sources. Thus, connections must be designed to provide an adequate seal between sealing surfaces when the devices and/or supply are compatible. Typical devices have a male and female connector that, when pressed together, form a fluid tight seal. The connectors come in different sizes and shapes and typically have O-rings or gaskets to help create a fluid tight seal.
Examples of a medical device connected to a fluid supply include compression therapy devices that are wrapped around a limb to prevent peripheral edema and conditions that form blood clots such as deep vein thrombosis. These devices typically include at least one air bladder that is sized and shaped for being applied around the limb. The bladder is inflated and deflated to artificially stimulate blood flow throughout the appendage that would normally result from, for example, walking. An example of such a device that is configured for disposal about a foot is shown in U.S. Pub. No. 2005/0187499. Typically, these compression devices are connected to a tube set which provides fluid communication from a pressure source to the compression device. A controller is employed to regulate the flow of fluid from the pressure source to the compression device.
The compression device, tube set and controller each contain connections for connecting and disconnecting the compression device from the pressure source. It is desirable to avoid erroneous connection of a medical device other than the compression device, for example an intravenous needle, to the pressure source.
In one aspect, a connector assembly for preventing sealing connection with a non-permitted, substantially uniform internal diameter conduit having an end face comprises a first connector having a floor and a coupling portion. The coupling portion projects outward from the floor and includes a sealing surface and a non-sealing surface. The non-sealing surface is located closer to a free end of the first connector than the sealing surface. The non-sealing surface is sized and shaped to hold the non-permitted conduit off of the sealing surface and prevent sealing therewith. The connector assembly includes a bleed passage located generally adjacent the floor for bleeding fluid out of the connector assembly.
In another aspect, a compression therapy device controller for controlling the supply of fluid from a source of pressurized fluid to a compression therapy device comprises a housing, a fluid port in the housing and a connector assembly for the fluid port. The connector assembly has a connector having a floor and a coupling portion. The coupling portion includes a sealing surface and a non-sealing surface. The non-sealing surface is located closer to a free end of the connector than the sealing surface. The non-sealing surface is sized and shaped to hold a non-permitted conduit off of the sealing surface and prevent sealing therewith. The connector assembly includes a bleed passage located generally adjacent the floor for bleeding fluid out of the connector assembly.
In a further aspect, a system for providing vascular compression comprises a controller, a tube set, and a compression therapy device. The controller includes a first connector assembly having a first connector having a floor and a coupling portion. The coupling portion projects outward from the floor. The coupling portion includes a sealing surface and a non-sealing surface. The non-sealing surface is located closer to a free end of the first connector than the sealing surface. The non-sealing surface is sized and shaped to hold a non-permitted conduit off of the sealing surface and prevent sealing therewith. The first connector assembly includes a bleed passage located generally adjacent the floor for bleeding fluid out of the first connector assembly. The compression therapy device includes a second connector including a sealing member. The tube set includes a tube and a third connector at one end of the tube having a sealing member adapted to engage the non-sealing surface and sealing surface of the first connector of the controller upon connection of the first and third connectors. The tube set includes a second connector assembly comprising a fourth connector having a floor and a coupling portion, the coupling portion including at least one sealing surface and at least one non-sealing surface. The non-sealing surface is located closer to a free end of the fourth connector than the sealing surface. The non-sealing surface is sized and shaped to hold the non-permitted conduit off of the sealing surface and prevent sealing therewith. The second connector assembly includes a bleed passage located generally adjacent the floor of the housing for bleeding fluid out of the second connector assembly. The non-sealing surface of the fourth connector is adapted to engage the sealing member of the second connector upon connection of the second and fourth connectors.
Other objects and features will be in part apparent and in part pointed out hereinafter.
Embodiments of the present disclosure are described herein below with reference to the drawings wherein:
Corresponding reference characters indicate corresponding parts throughout the drawings.
Referring now to the drawings, a connector assembly 30 constructed according to the principles of the present invention is shown in
In the illustrated example, a tube set 20 (
Referring to
Referring to
The receptacle 78 of the second connector 38 has an interior surface 74 and an annular shoulder 75 at the inner end of the interior of the receptacle (
The user must push, in the direction of the arrow “A” in
The open space defined by the longitudinal channels 58 prevents flush engagement of coupling portion 42 with the surface of a non-compliant connector or fluid conduit (lumen). The longitudinal channels 58 may have widths, depths, or lengths other than illustrated herein. One or more longitudinal channels 58 may be oriented parallel, offset, or undulating with the longitudinal axis of the connector 30. The longitudinal channels 58 can be replaced with a raised surface or roughness on the non-sealing surface 52. In addition, the openings 60 defined through a wall 62 help prevent a fluid seal between the first connector 36 and a non-compliant connector. An opening 60 is not limited to size and shape provided the opening leaks with a non-compliant connector attached to the first connector 36. One or more openings 60 diametrically opposed about the wall 62 facilitate leakage with a non-compliant connector.
An inner surface 54 of the first connector 36 and inner surface 74 of the second connector 38 form a fluid pathway therethrough. The inner surfaces (54, 74) are formed to pass fluid according to the particular flow requirements of a medical system such as the controller 2 and compression therapy device 1. Attachment portion 40 or attachment portion 80 is not restricted to one port. A “Y” connector 84 (
The cavities 66 prevent a seal between the first face 64 and a surface of a non-compliant connector. Each cavity 66 aligns with its corresponding outer longitudinal channels 58 to provide a path for leakage when the first connector 36 is inserted into a non-compliant connector. The transverse wall 68 prevents inserting a non-compliant connector into the first connector 36. The cavity 70 helps prevent a sealing surface between the first face 64 and a surface of a non-complaint connector. Likewise, inner longitudinal cavities 72 and the openings 60 though the wall 62 help prevent sealing with a non-compliant connector on the inside or outside of the first connector 36. The open spaces defined by the cavities 66 prevent flush engagement with coupling portion 42 and a surface of a non-compliant connector. A cavity or channel (66, 70, 72, 58) is not limited to a specific width, depth, or length. A cavity or channel (66, 70, 72, 58) is not restricted to orientation and can be parallel, offset or undulating. The present invention is not restricted to one non-sealing surface 52 or one sealing surface 48.
The user holds the second connector 138 using raised ribs 178 to grip and insert the first connector 136 into the second connector 138. In addition to functioning as grips, the ribs 178 also prevent a sealing connection between the second connector 138 and a tube or the like (not shown) received over the exterior of the second connector. The first connector 136 is inserted with its first end 144 passing beyond a sealing flange 176 located inside the second connector 138. The resilient sealing flange 176 conforms to the sealing surface 148 to form a fluid tight seal, after the sealing surface 148 passes beyond the non-sealing surface 152 and engages the flange 176. The user stops applying force when the face of the first end 144 abuts a shoulder 175 a distance beyond the sealing flange 176 of the second connector 138. A bar 181 is located at the inner end of the second connector 138 to inhibit a tube (not shown) from sealingly abutting a first tube 132 inserted inside an attachment portion 180 of the second connector.
The first tubing 132 forms a sealing interference fit with the inner surface 182 of the attachment portion 180. A second tubing 134 is inserted over an attachment portion 140 (
Coupling portion 242 is slidingly and sealingly received by a first end of second connector 238 into the gasket 276 to form a sealing connection between the first and second connectors. The key 252 snaps into the mating cavity 290 to releasably lock the first and second connectors 236, 238 is sealing connection. To release the first connector 236, the user depresses a button 286, with raised edges, and pulls the first connector 236 from the second connector 238, while holding the second connector 238. Depressing the button 286 deforms the first connector and moves the key 252 laterally out of the cavity 290. The key 252 prevents engagement with a non-compliant connector (not shown).
An alternate embodiment of a keyed connector assembly 530 illustrated in
The first connector 336 further comprises a coupling portion 342 with at least one longitudinal channel 372 therethrough (
In operation, the user inserts the cap 374 into the opening at the coupling portion 342. The O-ring 376 is deformed as it moves over the non-sealing surfaces 352 under the force of the user. The O-ring 376 comes to rest in the groove 349 and engages the sealing surface 348 (
The non-sealing surface 452 includes a first face 464. The first face 464 includes a transverse wall 468 that extends across the diameter of coupling portion 442. Transverse wall 468 is configured to prevent sealing engagement of the surface of coupling portion 442 with a non-compliant connector.
The second connector 438 comprises an attachment portion 480, a cap 474, an O-ring 476 inside the cap and sealingly mounted on the cap, and a flex collar 477 (
Referring to
The second connector 638 has a deformable O-ring 663 at the end of the receptacle 678 opposite the attachment portion 680, which is captured by a cap 655. Referring now to
Referring to
Referring to
The second connector 838 includes a receptacle 878. The receptacle 878 mounts to the attachment portion 880 by way of a flange 883. The receptacle 878 has an interior surface 874 and an annular shoulder 875 at the inner end of the interior of the receptacle (
The surface of the gripping portion 841 of the first connector 836 and the surface of the attachment portion 880 of the second connector 838 include raised ridges 814, 824. The raised ridges 814 of the first connector 836 include two generally opposed parentheses shaped first ridges 814a that extend generally lengthwise of the first connector and two flattened U-shaped second ridges 814b spaced lengthwise of the first connector and located between the first ridges (
It is to be understood that the ridges 814 and 824 may have shapes and arrangements that are different from what is illustrated and different from each other within the scope of the present invention. As shaped and arranged in the illustrated embodiment, the ridges 814, 824 provide for the passage of air, but also facilitate gripping the connector 836, 838. In the illustrated embodiment there are ridges (not shown) just like the ridges 814, 824 that may be seen in
Referring to
The first connector 836 includes a coupling portion 842 that projects outward from the floor 871. Standoff ribs 875 that project outward from the floor 871 are circumferentially spaced about the coupling portion 842. Bleed passages generally indicated at 879 are defined between the ribs 875 and floor 871. The bleed passages 879 are recessed from the ribs 875 and communicate with bleed passages 817. If a medical tube MT that is too small to receive the entire connector 836 therein is pushed over the coupling portion 842 as illustrated in
The coupling portion 842 includes a sealing surface 848 and a non-sealing surface 852. The non-sealing surface is closer to the free end of the first connector 836 than the sealing surface 848. The sealing surface extends around the perimeter of the coupling portion 842. The shape and contour of the coupling portion 842 is not restricted to that of the illustrated embodiment, so long as the coupling portion can engage and form a seal with the second connector 838, as will be described. The non-sealing surface 852 has a greater diameter than the sealing surface 848. A number of circumferentially spaced channels 858 in the non-sealing surface 852 extend lengthwise of the first connector 836. The channels 858 operate to inhibit the formation of a sealing connection of the coupling portion 842 with an interior surface of medical tubing.
The second connector 838 has a deformable O-ring 863 at the end of the receptacle 878 opposite the attachment portion 880. The O-ring 863 protrudes radially inward and is positioned axially so that the O-ring can sealingly engage the sealing surface 848 of the first connector 836 when the first connector 836 is received in the second connector 838 to make a fluid-tight connection. In this way, essentially only desired connections are allowed.
For the preferred embodiments described herein, the connectors are fabricated from semi-flexible and flexible materials suitable for vascular compression therapy such as, for example, polymeric materials, depending on the particular vascular therapy application and/or preference. Urethanes and silicones may also be used. One skilled in the art, however, will realize that other materials and fabrication methods suitable for assembly and manufacture, in accordance with the present disclosure, also would be appropriate. A number of alternating sealing and non-sealing surfaces is possible depending on the size and shape of the connector assembly.
When introducing elements of the present invention or the preferred embodiments(s) thereof, the articles “a”, “an”, “the” and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements.
In view of the above, it will be seen that the several objects of the invention are achieved and other advantageous results attained.
As various changes could be made in the above embodiments and methods without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
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