Large volume medical fluid vacuum collection canister

Surgery – Container for blood or body treating material – or means used...

Reexamination Certificate

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Reexamination Certificate

active

06270488

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to collection canisters designed for collecting, retaining and transporting medical fluids collected in surgical procedures. More particularly, the present invention relates to a new and improved blow molded fluid collection canister which, despite its thin wall thickness, can withstand internal vacuums of up to 1.0 atmosphere of vacuum (or about 14.69 psi) without buckling or inwardly collapsing.
Medical collection canisters have been used to collect and transport contaminated fluids generated in surgeries and other medical procedures. These prior art containers generally include open top buckets which collect fluids by gravity flow and vacuum canisters with portals which collect fluids from collection devices by applying a vacuum to one of the portals.
Open top buckets have been used to collect contaminated fluids from fluid collection devices in which the fluid flows from the collection devices to the bucket primarily due to the force of gravity. However, open top buckets pose serious health hazards because objects can fall into the bucket and splash the medical fluids on health care personnel. Open top buckets are difficult to transport and are susceptible to spilling. In addition, open top buckets are not sealed and are therefore unable to collect fluids by vacuum.
Prior art vacuum canisters have not been satisfactory, primarily because they have generally been too small for use in all medical procedures. Prior art vacuum canisters typically contain between 800 and 3,000 cubic centimeters of fluid. Many surgical procedures use large quantities of irrigation fluids, such as orthoscopic and cystoscopic surgery. These types of surgery have been known to utilize an amount of irrigation fluid significantly in excess of 3,000 cc. Furthermore, many extended surgical procedures such as liposuction, organ harvesting, organ transplantation, and open heart surgery produce significantly more than 3,000 cc of contaminated body fluids. Accordingly, numerous prior art vacuum canisters were required in many surgical procedures. These canisters are painstakingly connected in series and/or demand an extensive amount of attention by healthcare personnel. This creates the need for additional healthcare personnel in the operating room or divides the attention of existing healthcare personnel. Surgical procedures may be frequently interrupted to change the vacuum canisters. These interruptions may extend the length of the procedure which is decidedly disadvantageous to the patient.
Because of these shortcomings, collection systems capable of collecting larger volumes of fluid are required which do not involve the need for tandem setups, e.g. the hook up of several similar smaller containers to one vacuum source and one suction tubing end piece. Moreover, more cost effective manufacturing for large canisters is required. The only currently available large volume collection canisters capable of collecting volumes significantly larger than three liters are injection molded and have thick walls to prevent the canister from collapsing during use. The surface area of these prior art injection molded bucket canisters is relatively large and, the force which is directly proportional to the surface area, will increase significantly on the outside of the canister when a vacuum or negative pressure is pulled on the inside of the canister. The thick walled designs have an undesirably high material cost for their manufacture.
At present, the desire for high performance, low cost, large volume collection canisters for use with vacuum collection systems in medical procedures remains unsatisfied.
SUMMARY OF THE INVENTION
In order to remedy the shortcomings and deficiencies of the prior art devices, the present invention provides, in an embodiment, a new and improved large volume medical fluid vacuum collection canister for collecting medical fluids in surgical procedures. The collection canister preferably comprises a blow molded canister body defining a medical fluid receiving cavity. The canister body includes a pair of opposed upstanding sidewalls interconnected by a pair of opposed upstanding end walls, a top wall with an opening and an opposed bottom wall. The canister body has a generally rectangular cross-sectional configuration.
Each sidewall includes at least one re-entrant beam portion extending inwardly from a recess opening disposed in a central region of the sidewall to a beam end face disposed adjacent a middle of the medical fluid receiving cavity. The re-entrant beam portions extending inwardly from opposing sidewalls are disposed in registering alignment with each other so that their respective end faces are disposed in abutting face to face relationship. Preferably, the abutting end faces are connected together, such as by fusing in the molding process.
The bottom wall and each of the opposed end walls includes at least one inwardly directed bellows recess. Each bellows recess includes a central portion extending an entire width of the bottom wall or the end wall and includes a pair of opposed wrap around end portions extending from the central portion around the container an intermediate point defined in an adjacent sidewall. The top opening maybe sealably connected to a vacuum system lid for use in a medical or surgical vacuum system. The canister body is specially configured and designed to withstand internal vacuum pressures in the medical fluid receiving cavity of up to about 1.0 atmosphere of vacuum (or about 14.69 psi) of vacuum without buckling or inwardly collapsing.
In an embodiment, the upstanding end walls and bottom wall each include a plurality of bellows recesses.
In an embodiment, the re-entrant beam portions have a generally tapered four sided configuration which taper inwardly from the recess opening to the beam end face so that the beam end face has a smaller surface area than the surface area defined by the recess opening in the sidewall.
In an embodiment, all corner edges provided by intersecting surfaces of the container are all gently radiused to avoid any sharp edges. Each bellows recess has a generally three sided rectangular cross-section with radiused corner portions.
In an embodiment, the collection canister may further comprise a handle portion disposed above the top wall. In an embodiment, an elongate vertically oriented transparent or translucent viewing window may be provided in an upstanding side wall or both of the upstanding sidewalls to permit fluid filling height of medical fluids collected within the medical fluid receiving cavity to be visually observed from the outside of the container.* (Clear label —transparent or translucent polymer.)
In an embodiment, the collection canister is dimensioned and configured to define a medical fluid collection cavity of at least three liters and preferably up to about 9 to about 12 liters or more.
In an embodiment, the new and improved collection canisters are blow molded from a thermoplastic polymer molding composition. The thermoplastic polymer may comprise a variety of homopolymer, copolymer or polymer blend materials. These polymer formulations may include impact modifiers, fillers, dissimilar polymers and many other additives which are conventionally added to improve the processing properties or final physical properties of the canister. Preferably, the canister body comprises a thermoplastic polymer material having a Young's modulus of from about 200,000 psi to about 500,000 psi. Alternatively, the collection canister is preferably blow molded from a transparent or translucent material so that fluid fill height may be viewed directly through an upstanding sidewall. A see through label having volumetric markings may be placed on the sidewall to permit easy collected volume readings, or volumetric markings may be molded-in the sidewall during blow molding of the canister. A preferred canister comprises a thermoplastic polycarbonate material comprising only polycarbonate or comprising a blend of polycarbonate with a second thermoplastic molding resin.

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