This invention relates to facilities for sealing the terminals of cables, and more particularly to medical cables requiring sterilization.
Medical instrumentation cables used in surgical or other critical environments require sterilization between uses. Such cables typically have a coating of plastic or other sterilizable material, with terminals having end recesses in which reside a number of pins, sockets, or other electrical contacts. Sterilization typically involves immersion of the entire cable assembly in a solution that is effective to sterilize surfaces it contacts. However, such sterilants (such as glutaraldehyde) are corrosive with respect to electronic elements, and may leave behind conductive residue that can generate electrical shorts between conductors of a cable terminal. The electrolytic effects that occur during subsequent use of the cable may accelerate corrosion. Further, to be effective against contaminants that may reside in cracks or recesses, sterilants have fluid characteristics that provide ready penetration, which further aggravates their adverse effects on the electronic components.
To avoid these effects, cable terminals are normally provided with caps that seal them against the sterilant, preventing the sterilant from reaching the electronic contacts. While effective when properly used, problems arise when the caps are not properly used. A common concern is that a user responsible for sterilization may not be aware of the need to cap the cable, or may wrongly assume that the interior of the cable terminal must be sterilized. In other instances, a cap tethered to a cable terminal may be cut off, so that future capping is not possible. Occasionally, even well-informed and well-trained personnel may forget to cap the cable terminals, or may cap them inadequately to prevent incursion of sterilants. Inadequate capping may occur with screw-on terminals that are inadequately seated.
When a pattern of uncapped sterilization occurs, a significant cable failure rate develops. Moreover, even when capping occurs properly, conventional caps require increased time for processing, marginally increasing medical labor costs. Accordingly, there is a need for a system that provides for cable sterilization without dependence on user knowledge or skill to protect cable portions that are sensitive to sterilants.
The present invention overcomes the limitations of the prior art by providing a cap facility for a medical cable having a terminal defining a rimmed chamber containing electrical contacts. The facility has a frame that connects to the terminal. An arm is connected to the frame, and is movable between a first closed position and a second open position. The arm is biased to the closed position, and has a cap adapted to enclose the rimmed chamber when the arm is in the closed position. The cap has an arcuate motion path between the open position and an intermediate position proximate to the closed position, and an initial motion path deviating from the arcuate path, such that the cap moves away from the rim initially upon departing from the closed position. The facility may have a camming mechanism that provides the path.
A sealing mechanism 28 is connected to the terminal, and includes a frame 30 having a partial sleeve 32 that firmly and removably grips a cylindrical portion of the terminal body 14 at a position away from the rim 22. The frame has a boss portion 34 having a flat, circular face 36. A pivot axis 40 is central and perpendicular to the face, and intersects the terminal axis 26 at a right angle.
A pivot element 42 is pivotally connected to the frame for pivoting on the pivot axis between a closed position (shown) and an open position (to be discussed below). The pivot element includes a hub 44 centered on and overlaying the boss face 36, an arm 46 extending from the hub in a first direction toward the free end of the terminal (when in the illustrated closed position), and a handle 50 extending from the hub in a second direction approximately opposite the first direction.
The arm 46 is terminated in a circular cap portion 52 having a diameter slightly larger than the terminal rim 22, and overlaying the rim. The cap has a flexible elastomeric gasket 54 on the cap surface facing the pivot axis. The gasket is in the form of a dome, spherical section, or other suitable shape that provides a leak-proof-seal with the rim when the arm is in the closed position.
In the preferred embodiment, the frame 30 and pivot elements 42 are formed of a resilient thermoplastic resistant to the heat and chemicals used for sterilization, such as Radel R (Polyphenylsulfone). In one typical example, the terminal body 14 has a diameter of 0.627 inch, and the rim 22 has a diameter of 0.469 inch. The arm 46 may have an effective length between the pivot axis 40 and the cap 52 of 1.025 inch, and the gasket 54 may have a diameter of 0.525 inch. The gasket surface may have a radius of 0.875 inch, so that a line perpendicular to the surface of the gasket at the edge is offset by 76 degrees from the terminal axis 26. This will relate to the path the cap follows as the device is opened, as will be discussed below.
The pivot element is configured as will be discussed below to provide smooth operation that avoids the friction, wear, and damage that would lead to inadequate sealing if the pivot operation followed a simple arc centered on the pivot axis 40. The pivot axis is positioned in line with the connector axis 26 to provide accessibility of the actuator handle for ergonomic operation. The position also provides that the arm, when in the open position, is well rearward of the rim plane to avoid interference with an instrument to which the terminal is connected. However, a simple arc movement would cause the gasket to move laterally across the rim, without positive axial sealing force when in the closed position, and with the domed gasket resisting or preventing movement.
Accordingly, the preferred embodiment has a mechanism (to be discussed below) that provides a path of operation that provides positive capping force, and a lack of excessive operating friction. The cap follows a first path portion 56 between the closed position and the intermediate position, and a second path portion 58 between the intermediate position and the open position. To illustrate the paths, a selected point 60 at the center of the cap's outer surface is indicated (all points on the cap follow essentially similar paths.) The point is indicated as point 60′ at the intermediate position, and as point 60″ at the open position. The first path portion 56 extends at a significant angle away from the plane of the rim 22. The angle is established so that even the edge of the gasket recedes from the rim as the cap opens. The angle is at least greater than the angle of the gasket edge surface noted above, and is preferably at least 15 degrees. Thus, there is a significant axial component to the motion, and no rubbing of the gasket on the rim as the device is opened. In addition, with the pivot element biased to the closed position, the biasing force is essentially along the line of the path, so that there is a significant biasing force component in the axial direction to maintain a seal as needed for sterilization.
The second path portion 58 is essentially a simple circular arc centered on the axis 40. When the arm returns from the open position, it follows the same path.
The arm 46 defines a hub aperture 82 that receives the frame's central pin 64. The aperture 82 is significantly larger than the pin diameter, so that the arm has some free play in the lateral direction defined by the connector axis 26 (it also has free play in both axes that define the plane of the face 36.) The hub portion 62 has an arcuate perimeter portion that provides a first cam surface portion 84 centered on the hole 82. The perimeter also defines a notch or recess 86 in the cam surface at a position opposite the arm extension, in registration with the cam pin and roller 70 when the device is in the closed position. The notch has an arcuate portion 90 having the same radius as the roller 70, and a flat ramp portion 92 extending tangentially from the arcuate portion 90 to the first cam surface 84.
In the quadrant opposite the cam surface 84, the arm hub 62 has a bearing surface 94 at a short radius from the hole 82, providing a narrow curved wall that fits between the frame's central pin 64 and the bullet 80. The bullet bears on the bearing surface to bias the hub in the direction of the cam pin and roller 70. In the preferred embodiment, the hole 82 has a diameter of 0.225 inch, the central pin has a diameter of 0.125 inch, the roller has a diameter of 0.150 inch, the cam surface 84 has a radius of 0.75 inch, and the notch extends to a depth of 0.100 into the cam surface 84. The bullet spring has a force of one pound in the position indicated, and the torsion spring provides a torque in the range of 1.0 to 1.5 inch-pounds.
The arm further includes a spring support pin 96 near the forward limit of the cam surface 84, and a torsion spring 100 received on the central pin 64 has arms that bear outward against the pin 96 and the cam pin 66, to bias the arm into the closed position, and to resist opening of the arm, except under deliberate force.
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While the above is discussed in terms of preferred and alternative embodiments, the invention is not intended to be so limited. For instance, while the notched cam is on the arm, and the roller serving as a cam follower is on the frame, these functions may be reversed. Moreover, other mechanisms may be employed to provide the different motion paths (one portion to facilitate decapping and recapping without excessive friction, the other portion to facilitate movement of the cap to a position rear of the rim plane.) The actuator need not be a pivoting lever, but may be a sliding sleeve or a linear actuator such as a button whose motion converts to the desired cap operation.
A pivot element 142 is pivotally connected to the frame for pivoting approximately on the spindle between a closed position and an open position. The pivot element includes a hub 144 centered on and overlaying the face 136, an arm 146 extending from the hub in a first direction toward the free end of the terminal, and a handle 150 connected to and extending from the hub in a second direction approximately opposite the first direction.
The arm 146 is terminated in a circular cap portion 152 having a diameter slightly larger than the terminal rim 22 (not shown), and overlaying the rim. The cap has a flexible elastomeric gasket on the cap surface facing the pivot axis as noted above.
The frame defines a cam channel or track 160 having a first portion 162 that is arcuately centered on the spindle 141, and a second portion 164 that deviates from the arcuate path away from the spindle in a direction away from the terminal rim 22 (not shown.) A face seal, skirt seal or O-ring 166 is received between the face 136 and the arm hub 144 to provide a seal against intrusion of sterilants.
The hub defines a major cylindrical pocket 170 generally centered on the axis 140 and receiving a compressible cam assembly 172, The pocket has a floor (not shown) with a central aperture. A cam roller 173 is connected to the lower surface of the hub, so that it can ride in the channel 160 as the arm pivots, causing the arm to shift laterally in the manner discussed below.
The cam assembly includes a bushing element 174 with a spring arm 176 pivotally connected to the bushing. The bushing element is secured by screw 180 to the spindle, with flats on the sides of the spindle mating with an oblong central hole 182 to prevent rotation of the bushing with respect to the frame 130. The floor of the arm hub is captured between the bushing and the face 136, so that the arm is free to rotate, and also to shift along axis 26 as will be needed for the function discussed below. Thus, the bushing is essentially part of the frame, except that it needs to be detachable for assembly.
The arm 176 pivots with respect to the bushing 174 at pivot axis 184, and has a generally cylindrical outer surface that bears against the interior surface of the sidewall of pocket 170, generally contacting the side of the pocket away from the connector rim 22 (not shown). A compression coil spring 186 is positioned between the respective end portions of the bushing and arm 176 to bias them apart. This causes both surfaces to bear outwardly against the hub pocket, as will further be discussed below.
A torsion spring 190 is received within the hub, in a space defined between the bushing and the spring arm 176. One leg of the spring 190 engages a notch on the lower portion of the spring arm (essentially engaging the fixed frame via the bushing) and the other engages the cap 192. This causes the handle and arm to resist pivoting robustly, and to return firmly to the closed position when released from an open position. A lid 192 is connected to the hub to enclose and seal the pocket 170, to secure the components therein, and to prevent entry of sterilants. Screw 194 attaches the handle 150 to the hub, and set screws 196 are adjustable to limit lateral movement of the hub in a direction perpendicular to axes 26 and 140.
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While the above is discussed in terms of preferred and alternative embodiments, the invention is not intended to be so limited.
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/US03/31541 | 10/3/2003 | WO | 00 | 1/22/2007 |
Publishing Document | Publishing Date | Country | Kind |
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WO2005/043689 | 5/12/2005 | WO | A |
Number | Name | Date | Kind |
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5800188 | Barber et al. | Sep 1998 | A |
Number | Date | Country |
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4214031 | Nov 1993 | DE |
0401723 | Dec 1990 | EP |
0709924 | May 1996 | EP |
Number | Date | Country | |
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20070212924 A1 | Sep 2007 | US |