Medical instrument flow stop interface

Details Medical instrument flow stop interface Medical instrument flow stop interface

2001-05-04

2003-10-07

Hayes, Michael J. (Department: 3763)

Surgery

Means for introducing or removing material from body for...

Treating material introduced into or removed from body...

C417S234000

Reexamination Certificate

active

06629955

ABSTRACT:

The invention is generally related to the field of intravenous (“IV”) infusion devices such as infusion pumps and the associated flexible IV tubing and flow stop devices, and more particularly, to devices used to prevent free flow in an IV tube when the infusion pump is disengaged from the IV tube.
BACKGROUND
It is a common practice to deliver fluids such as medications to a patient intravenously by means of a pumping device such as a “four finger” pump or a peristaltic pump. Such pumps are useful because they can deliver the medication in a highly controlled fashion, and because they do so without coming in contact with the medication. The fluid is moved through a flexible IV tube by pressing a pumping member against the outer surface of the tube sufficiently to force fluid downstream through the tube into the patient.
Both a four finger pump and a peristaltic pump operate by occluding the tube at all times so that there can be no free flow or uncontrolled flow between the fluid reservoir and the patient. In the case of a four finger pump, either an upstream valve finger or a downstream valve finger occludes the tube at all times. In the case of a peristaltic pump, at least one of the peristaltic fingers is at all times occluding the tube.
It is common for the pumping mechanism to be disposed in a housing with a hinged door. The tube through which the fluid is to be moved is placed in contact with the pumping mechanism inside the door, with the upstream and downstream ends of the tubing typically extending out the top and bottom, respectively, of the door opening. As the door is shut over the tube, a platen presses against the IV tube to provide a backing surface against which the pumping members can occlude the tube.
This arrangement of the IV tube relative to the pumping mechanism requires that there be some means for preventing flow in the tube when the door is open. Otherwise, during the process of mounting or removing the tube from the pumping mechanism, an unwanted flow of fluid could occur in the IV tube. This could result in the uncontrolled infusion of medication into the patient under the influence of the static head pressure in the tube. Known devices for preventing unwanted flow in the tube include manual clamps separate from the infusion pump, and automatic occluding devices mounted on the pump.
The manual clamp devices require some manipulation skill on the part of the attending technician, and there is the chance that the technician will forget to properly time the occlusion of the tube relative to the opening of the door on the pumping device. Furthermore, the door may be accidentally opened which could result in free flow in the tube.
The automatic flow stop engagement system disclosed in U.S. Pat. No. 5,453,098 has been a major advance in the art. However, in the case where the hinge or hinges of the door of the pump must be moved forward so that the pump has a narrow profile and can be placed closely beside another medical device without interfering with that device when the pump door is opened, such a door may not be squared with the tube. When the platen is mounted to the inner surface of the door, it may apply an undesirable rolling force to the tube when the door is opened and closed. Such a rolling force may stress the tubing any may move the tube out of the correct position in relation to the pumping mechanism and the automatic flow stop feature provided by the pumping mechanism may not be present because the tube is out of position. Typically, the action of opening the door is relied on to initiate the occlusion of the IV tube by the clamp and the action of closing the door is relied on to initiate the release of the IV tube from the clamp. Therefore, free flow of fluid could occur if the door is not located properly in relation to the tube. However, for purposes of ease in automatically controlling the clamp on the tube by the actions of the door opening and closing, it is desirable that door continue to effect such clamp control.
In designs where an engagement device such as a hooked arm is formed as part of the door and which engages the flow stop to move it to the occlusion position before the door permits disengagement of the pumping mechanism with the tube, it would be desirable to provide a warning to medical treatment personnel if the engagement mechanism is not in the correct position before the door is opened. A manual clamp could then be applied to the tube before the door of the pump is opened.
Therefore, those skilled in the art have recognized a need for an apparatus that will automatically and positively occlude an IV tube before the pumping mechanism is disengaged from the tube. A need has also been recognized for an apparatus that will automatically and positively maintain the IV tube in an occluded state until after the pumping mechanism is engaged with the tube and will then move the flow stop to a flow configuration. A need has also been recognized for an apparatus that will perform the above-discussed operations on the tube with a door that has been mounted in a more forward position to accommodate the placement of the pumping apparatus in close proximity to other medical devices. A further need has been recognized for a detection system that will determine if a flow stop engagement device is present with the pump door and will provide an alert if the engagement device is not detected. The present invention fulfills these needs and others.
SUMMARY OF THE INVENTION
The present invention is directed to avoiding the free flow of fluid through a medical instrument by judicious operation of a flow stop in conjunction with instrument loading and unloading operations. With more particularity, a platen is used to control a flow stop coupled to a tube so that movement of the door of the medical instrument controls the configuration of the flow stop.
In one aspect in accordance with the invention, an apparatus is provided for controlling a flow stop to reside in an occluding configuration at which the flow stop occludes a resilient tube and to reside in a flow configuration at which the flow stop permits flow through the resilient tube by the position of a door that is mounted with a first hinge to the housing of a medical instrument, the apparatus comprising a base on the flow stop for holding the resilient tube, a slide clamp slidably mounted on said base and engaging the tube, the slide clamp adapted for movement between the occluding configuration and the flow configuration, and a platen mounted in relation to the housing with a second hinge, the second hinge located at a position different from the position of the first hinge but such that the platen is disposed between the door and the slide clamp of the flow stop wherein moving the door towards the housing engages the platen causing it to engage the slide clamp to move the slide clamp to the flow configuration whereby fluid may flow through the tube.
In more detailed aspects, the platen comprises a body portion and a flow stop actuator portion disposed as an extension of and offset from the body portion of the platen such that the body portion of the platen engages the tube against the medical instrument while being pivoted into position by the movement of the door and the actuator portion contacts the flow stop before the slide clamp may be moved to the open position. Further, the flow stop comprises a locking arm engaged with the slide clamp that prevents the slide clamp from being moved to the flow configuration, and the flow stop comprises a release tab connected to the locking arm that disengages the locking arm from the slide clamp when the release tab is moved to a released position, wherein the flow stop actuator portion of the platen is disposed so as to contact the release tab of the flow stop and move it to the released position before the slide clamp is moved to the flow configuration.
The medical instrument also includes datum pins located at selected positions on the instrument, the pins having a predetermined length selected so that when the platen is engaged with th

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