Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-06-12
2001-07-17
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S249000, C251S007000
Reexamination Certificate
active
06261262
ABSTRACT:
CROSS REFERENCE TO RELATED APPLICATION(S)
Not applicable.
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
Not applicable.
REFERENCE TO A MICROFICHE APPENDIX
Not applicable.
TECHNICAL FIELD
This invention relates to a liquid delivery system and is especially suitable for use as part of an infusion pump system designed to deliver parenteral and enteral fluids, as well as whole blood or red blood cell components, using a wide variety of standard intravenous administration sets and fluid containers.
BACKGROUND OF THE INVENTION
AND
TECHNICAL PROBLEMS POSED BY THE PRIOR ART
One conventional type of infusion pump system employs a peristaltic pump in conjunction with an intravenous administration set. The set consists of flexible thermoplastic tubing through which fluid flows from a suspended container, such as a flexible bag or rigid bottle, to a patient's indwelling vein access device, such as a needle or cannula inserted into the patient. A length of the administration set tubing between the fluid container and the patient is mounted in the peristaltic pump which sequentially squeezes adjacent sections of the tubing so as to pump the fluid via a peristaltic action along the tubing into the patient.
While such pumping systems function generally satisfactorily, there are some disadvantages with various commercial products employing such systems. For example, when medical personnel remove the tubing from the pump, care must be taken to insure that the tubing has been closed with a suitable device, typically a slide clamp, so as to prevent free flow of the fluid from the container into the patient. Thus, it would be desirable to provide an improved system in which the tubing is automatically closed by a suitable clamp before the tubing is removed from the pump.
Further, it would be beneficial if such an improved system could be employed with a relatively simple clamp mounted on the tubing. Preferably, such an improved system should be capable of functioning with a simple or standard slide clamp on standard intravenous administration set tubing and should not require the use of a more complicated, multi-piece clamping mechanism on such tubing.
Typically, a standard intravenous administration set is disposable and is provided to medical personnel in a sterile, protective package. It would be desirable to provide such an administration set with a tubing clamp that can be automatically operated by the improved pump system and that has a relatively simple design which employs a relatively small size and shape facilitating low cost manufacture, which is easy to sterilize, and which is convenient to package, store, and handle.
Further, an improved infusion pump system should accommodate relatively simple assembly procedures. In particular, it would be desirable to provide an improved infusion pump system wherein the administration set tubing can be loaded into the infusion pump in a logical, and preferably intuitive, manner—starting at the top of the pump and terminating at the bottom of the pump. Such a simple tubing loading process can be easier to learn and is less likely to be improperly executed than less intuitive processes.
The present invention provides an improved infusion pump system which can accommodate designs that have the above-discussed benefits and features, which is convenient to use, and which is cost-effective with respect to its manufacture and operation. The system is easily operated and can be used with a wide variety of standard administration sets and fluid containers. The system is designed to meet the growing demand for hospital-wide standardization, as well as alternatesite, in-home healthcare standardization.
SUMMARY OF THE INVENTION
The improved system of the present invention accommodates safe delivery of fluids to a patient. The system is convenient to operate and is easy to set up.
In the preferred embodiment, the system does not permit the loading of the administration set tubing into the pump with an anti-free flow slide clamp unless the clamp is initially in a fail-safe, closed condition on the tubing.
Further, in the preferred embodiment, the pump includes a door closure system which functions to (1) automatically open the anti-free flow slide clamp when the door is closed, and (2) automatically close the anti-free flow slide clamp when the door is opened. The medical operator of the system need not take any special step upon opening the pump door to ensure that the tubing is closed by at least one clamp. This eliminates, or at least minimizes, the possibility of fluid free flowing into a patient upon removal of the tubing from the pump.
The preferred embodiment of the system also accommodates a variety of standard, gravity, intravenous administration sets. Such sets can be conveniently loaded into the pump in a logical, intuitive, top-to-bottom sequence involving relatively few manual operations.
Further, the improved system can be readily accommodated in an infusion pump having a variety of other conventional or special features relating to automatic pumping operation, air purging, flow occlusion monitoring, air-in-line sensing, alarm features, self-test and diagnostic systems, volume/time programming for automatic secondary flow rate calculations, nurse callback, battery backup, etc.
One aspect of the present invention provides a system for delivering fluid through tubing. The system includes a clamp for clamping the tubing. A pump includes a housing having a receiving path for receiving the tubing through which the fluid is pumped. The pump also includes a carrier mounted in the housing for carrying the clamp on the housing. The carrier is movable relative to the housing, but is not intended to be removable during normal operation of the system.
Another aspect of the present invention relates to an improvement in a pump. The pump includes (1) a receiving path for receiving tubing extending from an inlet end of the path to an outlet end of the path, and (2) a peristaltic pump head along the receiving path between the inlet end and the outlet end. A carrier is provided in the pump adjacent the receiving path between the inlet end and pump head. The carrier is adapted to receive an anti-free flow clamp in a closed condition squeezing the tubing into a closed configuration. A portion of the clamp is positioned by the carrier across the receiving path.
In a preferred embodiment of the invention, the clamp has an open condition in which the tubing is free to return to an open configuration. The tubing, with the clamp disposed thereon, can be loaded into the receiving path of the pump from the inlet end to the outlet end.
According to another aspect of the invention, a peristaltic pump includes a housing which defines (1) a receiving path for receiving tubing extending from an inlet end of the path to an outlet end of the path, and (2) a groove that is (a) oriented generally normal to a portion of the receiving path, and (b) communicates with the receiving path. Mounted in the pump is a carrier into which can be inserted an anti free-flow clamp. In the preferred embodiment, the clamp is inserted in a closed condition squeezing the tubing into a closed configuration. The carrier is located adjacent the housing receiving path and groove. The carrier defines first and second slots for receiving portions of the clamp. The second slot extends from the first slot, and the second slot is generally normal to the first slot and is aligned with the housing groove.
According to yet another aspect of the invention, a pump includes a housing having a receiving path for receiving tubing through which fluid is pumped. The pump has a door pivotal about an axis. In the preferred embodiment, the door can be pivoted between a closed position covering the receiving path and an open position exposing the receiving path. A carrier means is provided on the housing for carrying a clamp on the tubing. The carrier means is movable relative to the housing in a direction parallel to the door axis.
According to yet a further aspect of the invention, a pump includes
Briggs Kenneth D.
Hall Allen C.
Sampson Russel M.
Abbott Laboratories
Hayes Michael A.
Seidel Richard K.
Vrioni Beth A.
Woodworth Brian R.
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