This relates to the field of medical devices and more particularly to flexible medical tubing and clamping thereof.
Catheters may be located in various venous locations and cavities throughout the body of a patient for introduction of fluids to a body or removal of fluids from the body. Such catheterization may be performed by using a single catheter having multiple lumens. A typical example of a multiple lumen catheter is a dual lumen catheter assembly in which one lumen introduces fluid and the other lumen removes fluid. Catheterization may also be performed by using multiple single-lumen catheters, such as TESIO® catheters sold by Medical Components, Inc. of Harleysville, Pa.
Each catheter lumen is typically connected to a distal end of an extension tube via a hub permanently secured to the catheter and the distal ends of the extension tubes. Each extension tube has a standard connector, such as a luer fitting, at its proximal end for connection to a medical device, such as a hemodialysis machine. A clamp, such as a Halkey Roberts clamp, is typically disposed over the extension tube. The clamp restricts fluid flow through the extension tube by compressing and closing the extension tube between a pair of clamp jaws. For long term catheterization, the clamp must be opened and closed numerous times, which may lead to a failure of the extension tube and blood loss from the catheter.
Clamps of the basic Halkey Roberts type are well-known, and are disclosed in various patents such as U.S. Pat. Nos. 3,942,228; 4,560,378; 4,588,160; 4,589,626; 5,035,399; 5,203,056; and 6,089,527. Structurally, such a clamp is a one-piece plastic member defined more or less by a skeletal framework and having two transverse end walls with apertures therethrough through which the tubing extends, whereby the clamp self-retains on the tubing even in the unlatched or open position. A latch arm extends from one end wall toward the other and includes a latching structure, and the other end wall includes a catch engageable with the latching structure. The latch arm and an opposing wall to the latch arm include tubing engaging surfaces, or clamp jaws, that engage and compress the tubing when the latch arm is in the latched position, which occludes the tubing to shut off fluid flow through the tubing until the clamp is released.
The end wall of the clamp thus described extends to a free end that is exposed and thus may become easily snagged by foreign objects such as clothing or wires or the like, resulting in unintentional and undesirable delatching and unclamping from the tubing. Also, the tubing's resistance to being clamped exerts force in a direction tending to pry the latch arm to overcome the catch and thus open inadvertently, and the skeletal end wall that is remote from the latching arrangement becomes stressed and weakened over repeated clamping/unclamping cycles, eventually leading to failure and breakage in many cases. Commercially available Halkey Roberts clamps commonly extend along the tubing for a length of just under one inch (254 mm).
In above-cited U.S. Pat. Nos. 4,588,160; 4,589,626; and 4,673,161, the clamping jaws are axially offset. In another patent, U.S. Pat. No. 4,623,102, a clamp is disposed transversely and provides a pair of planar clamping surfaces to grip the tube. In both U.S. Pat. Nos. 4,589,626 and 4,623,102, the clamp has two or more clamping positions, enabling either selective occlusion or capability of utility with tubing of different diameters.
It would be desirable to provide a clamp that is more resistant to delatching, that is more durable and that extends substantially less than one inch along the tubing.
Briefly, the present invention is a clamp assembly for flexible tubing that includes a housing and a clamp that is slidable within the housing between a first, or open, position and a second, or closed, position, wherein when in the second position the tubing is occluded. The housing includes openings in two opposing side walls thereof through which the tubing extends, so that the clamp assembly is oriented, and the clamp is movable, transversely with respect to the tubing and can occupy much less length of the tubing. One of the housing and clamp includes at least a pair of tubing-engaging ribs that engage and compress the tubing against a surface of the other of the housing and clamp, to occlude the tubing when the clamp has been moved to its second position. Preferably, the other of the housing and clamp also includes at least one tubing-engaging rib that compresses the tubing in cooperation with the tubing-engaging ribs of the other when the clamp is in its second position.
Preferably, the clamp includes a pair of latch arms that extend longitudinally from an end thereof through the housing to latch with catches of the housing at a corresponding end thereof when the clamp has been moved to its second position. The tubing when clamped exerts resistance against the ribs of the clamp assembly in a direction transverse to the tubing's axis. The clamping resistance is perpendicular to the deflection direction of the latch arms, thus having an insignificant effect on the latching arrangement. Furthermore, any incidental engagement of the tubing with the latch arms would tend to press the latch arms outwardly against the interior side wall surfaces of the housing, preventing deflection of the latch arms, all of which enables the clamp assembly of the present invention to have superior resistance to inadvertent unclamping and to be more durable and robust over repeated clamping cycles.
Also, preferably, the clamp includes a pair of detents that cooperate with recesses of the housing to secure the clamp in an assembled state with the housing when the clamp is in its first or open position, thus securing the clamp assembly to the flexible tubing. In one embodiment, the pair of detents comprises the latch arm free ends, and the recesses comprise a pair of slots spaced from the second end into which the latch arm free ends snap when the clamp is in its first or open position.
Another embodiment of clamp assembly has an oblate or ovate or ovoid shape that is distinctly atraumatic to the patient. In this embodiment, the assembly comprises a pair of clamping members wherein each member defines a portion of the channel along which the flexible tubing extends, and thus can be applied to the tubing from laterally thereof rather than require insertion through a housing aperture of an end of the tubing, as in the first embodiment, and can, if desired, be easily removable therefrom.
The clamp assembly of the present invention has a more robust structure that is far less likely to be delatched and unclamp the tubing, and less likely to be breakable after repeated usage, and occupies much less length of the tubing.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiment of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:
Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The embodiments illustrated below are not intended to be exhaustive or to limit the invention to the precise form disclosed, but are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.
Clamp assembly 10 of
At least one of the clamp 14 and the housing 12 includes at least one tubing-engaging rib extending at least to the channel through which the tubing 100 will extend upon mounting of the assembly 10 to the tubing so that the at least one rib (or jaw) engages and compresses the tubing against an opposing surface of the other of the clamp and the housing, upon movement of the clamp 14 to its second position, thus occluding the tubing. In
Referring to
It is also seen that free ends 64 are exposed to be manually deflectable toward each other to delatch the latch arms 62 when desired, to return clamp 14 to its first, or open, position primarily by pressure from the occluded tubing tending to resume its original cylindrical shape. Second end 26 of housing 12 is seen to have a boss 36 projecting outwardly between the channel exits to provide protection against inadvertent engagement with latch arm free ends 64 and possible unintentional and undesirable delatching thereof. As is easily discerned, latch arms 62 are deflectable inwardly, and any engagement by the flexible tubing within the channel especially when occluded simply urges the latch arms against the housing side walls and has no tendency to delatch the latch arm free ends from their latching engagement with the housing.
In
Seen best in
A second embodiment of clamp 110 is depicted in
First clamp portion 112 is shown to include two tubing-engaging ribs 130, while second clamp portion 114 includes three tubing-engaging ribs 160 which are offset from tubing-engaging ribs 130 to define a tortuous path or channel 128 for the flexible tubing, as demonstrated in
As with clamp 14 of
It is also seen that, when clamp 110 is in its second or occluding position, free ends 164 of latch arms 162 are exposed to be manually deflectable toward each other to delatch the latch arms 162 when desired, to return clamp assembly 110 to its first, or unclamping, position primarily by pressure from the occluded tubing tending to resume its original cylindrical shape. First clamp portion end 126 is seen to have a boss 136 projecting outwardly between the channel exits to provide protection against inadvertent engagement with latch arm free ends 164 and possible unintentional and undesirable delatching thereof. As is easily discerned, latch arms 162 are deflectable inwardly or toward each other, and any engagement by the flexible tubing within the tubing channel especially when occluded simply urges the latch arms against the clamp portion side walls and has no tendency to delatch the latch arm free ends from their latching engagement with first clamp portion 112.
Clamp assembly 10,110 can have a dimension parallel to the flexible tubing 100 extending therethrough, of less than one-half of an inch, or under 127 mm, and is structurally robust and durable over many actuation cycles, with great resistance to inadvertent delatching. The clamp and the housing may be molded of polyethylene plastic, or of polypropylene, or other suitable materials.
It will be appreciated by those skilled in the art that changes could be made to the embodiment described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiment disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 61/108,940 filed Oct. 28, 2008.
Number | Date | Country | |
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61108940 | Oct 2008 | US |