Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Statutory Invention Registration
1999-12-13
2003-11-04
Carone, Michael J. (Department: 3641)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S151000
Statutory Invention Registration
active
H0002090
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to fluid administration systems, and more particularly to fluid administration systems having an occluder adapted to prevent fluid free-flow. More specifically, the present invention relates to a one-piece unitary occluder for use with a pump of a fluid administration system which is connected to a tube assembly and adapted to prevent fluid free-flow therethrough.
2. Prior Art
Administering fluid containing medicine or nutrition to a patient is generally well-known in the art. Typically, the fluid is supplied to a patient by a tube assembly which interconnects a fluid source to a patient. The fluid is supplied to the patient through either an enteral connection which accesses a visceral organ (gastrointestinal feeding), or through a parenteral connection which accesses a non-visceral organ (intravenous feeding).
The fluid flow rate through the tube assembly is typically controlled by a mechanical clip which is designed to progressively occlude the tube and selectively impede the fluid flow induced by gravity. One such mechanical clip which operates to occlude a portion of the tube is a conventional roller clamp that has a hollow body with opposed openings and a pair of angled slots opposite one another which are formed transverse to the openings. The clip further includes a wheel having an axle which is coupled to the body with the axle fitted within the slots. The tube is the inserted through the openings and the wheel is rolled along the slots to pinch a portion of the tube against the body which progressively occludes the tube. Although devices of the above-mentioned character operate to provide a cost-efficient method for controlling the flow rate, these devices must be manually actuated. Further, another drawback is that the wheel may be inadvertently bumped or jostled out of position resulting in an inappropriate flow rate.
In order to enhance flow-rate control, calibrated pumps have been found to be useful. One such pump that has been used in the art is a peristaltic pump connected in-line along a portion of the tube between the fluid source and the patient. The pump advances the fluid through the tube by occluding successive portions of the tube and then urging each occluded portion forward. When a pump is utilized to control the flow rate, mechanical clips are typically not employed or are disengaged to prevent the clamp from interfering with the flow rate.
Peristaltic pumps are generally classified as being either a rotary, such as the device described in U.S. Pat. No. 4,913,703 to Pasqualucci et al. entitled “Safety Interlock System for Medical Fluid Pumps”, or linear, such as the device described in U.S. Pat. No. 4,493,706 to Borsangi entitled “Linear Peristaltic Pumping Apparatus and Disposal Cassette Therefore”, both of which are incorporated herein by reference. Generally, rotary peristaltic pumps have a motor driver rotor mounted on a surface of the pump which carries two or more circumferentially spaced apart rollers designed to occlude a portion of the tube. As the motor rotates the rotor, the spaced apart rollers are sequentially brought into contact with, and occlude, portions of the tube. A predetermined volume of fluid is contained between each of the occluded portions so that this measured volume of fluid is advanced through the tube.
Rotary peristaltic pumps can be further subclassified as being either clinical, for use with bedridden patients, or ambulatory, for use with patients that have some degree of mobility. The '703 patent describes a representative clinical pump having a tubing assembly with a pair of members each receivable within a corresponding recess. The tube assembly is engaged with the pump by coupling the first member with the corresponding recess, stretching the tube around the rotor, and then coupling the second member with the other recess. In contrast, ambulatory peristaltic pumps, such as that described in U.S. Pat. No. 5,181,842 granted to Sutherland, et al. entitled “Peristaltic Infusion Device”, include a battery operated pump for use by patients who are capable of some degree of mobility. These peristaltic pumps have a rotor member and a swing arm rotatably mounted adjacent to the rotor. The arm is movable between an open position and a closed position. In the open position, the tube assembly is slack to simplify threading it about the rotor. Then the swing arm is biased into the closed position to automatically align and stretch the tube around the rotor by the arm.
Although clinical and ambulatory peristaltic pumps have substantially improved the art, one drawback found with such devices is that once the tube assembly is disengaged, either intentionally or unintentionally from the pump, the flow rate is unrestrained as the fluid is drawn through the tube due to gravity. This situation is known as fluid free-flow and may present an undesirable, or even life threatening situation, if undetected because of the risk of overfeeding or overmedicating a patient.
In order to overcome the above-noted drawbacks to fluid administration systems utilizing pumps, several devices have been suggested which operate to automatically occlude a portion of the tube and prevent fluid free-flow if the tube becomes disengaged from the pump while also permitting uninhibited fluid flow when the assembly is properly engaged to the pump. For instance, a variety of automatic occluders have been suggested to improve the art such as the device disclosed in U.S. Pat. No. 4,689,043 to Bisha entitled “IV Tube Activator” which describes a clamp for use with a peristaltic pump. The clamp includes a V-shaped channel which is spring biased into a closed position where the narrow portion of the V-shaped channel is sized to substantially crimp, or occlude, a portion of the tube and prevent fluid flow therethrough. The clamp may be urged into an open position by a handle which overlays the pump and depresses the springs such that the tubing is positioned within the wider portion of the V-shaped channel to permit unrestricted flow through the tubing. If the handle is released either intentionally or unintentionally, the V-shaped portion will automatically slide into the closed position and prevent fluid free-flow by crimping or occluding a portion of the tubing assembly.
Another automatic occluder is disclosed in U.S. Pat. No. 5,704,582 to Winterer, et al. entitled “Pinched Clipped Occluder for Infusion Sets” which describes a clip that is positioned between a housing and a cover of a pump. The clip has a plunger biased by a spring towards a portion of the tube so that the tubing may be occluded. Fluid flow through the tube may only be established when the plunger is biased away from the tube which occurs when the cover is properly coupled with the housing. However, once the cover becomes disengaged from the housing, the plunger is automatically biased into the closed position by the spring to prevent fluid free-flow.
Although both of the aforementioned automatic occluders have advanced the art, both devices are mechanically complex and prone to mechanical failure. In addition, the mechanical complexity also results in occluders which are expensive to manufacture.
Accordingly, one skilled in the art can best appreciate that several advances would be still be desirable. For instance, it would be desirable to have a fluid administration system which has an automatic occluder capable of preventing fluid free-flow through a portion of the tube. In addition, it would also be desirable to have an occluder which has a one-piece unitary design.
OBJECTS AND SUMMARY OF THE INVENTION
In brief summary, the present invention overcomes and substantially alleviates the deficiencies present in the art by providing a one-piece unitary occluder for a fluid administration system which is adapted to prevent fluid free-flow. The one-piece unitary occluder is used in a fluid administration system having a pump connected in-line along a tube assembly.
Generally, the pump includes a body having a pair
Carone Michael J.
Lewis, Rice & Fingersh L.C.
Sherwood Services, A.G.
Thomson M.
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