DISPOSABLE FLUID COLLECTION APPARATUS

REFERENCE TO PREVIOUS APPLICATIONS: This Application is a Continuation-in-Part of U.S. Application Serial No. 09/562,064 filed May 1, 2000 which is itself a Continuation in Part of U.S. Application 00/020,708, Filed February 9, 1998 which was based, in part, upon U.S. Provisional Patent Application 60/174,617, filed January 5, 2000.

TECHNICAL FIELD

The disclosed embodiments relate to methods and apparatus for collecting fluids during surgery. Embodiments disclosed herein provide apparatus and methods for collecting infused and bodily fluids released during a wide variety of surgical procedures.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 is a perspective view showing an embodiment of foldable disposable fluid collection apparatus with an attached surgical drape;

Fig. 2 is an exploded view of a double bi-fold embodiment of a disposable fluid collection apparatus.

Fig. 3 is a cross-section of an embodiment of the disposable fluid collection apparatus of Fig. 2 taken at 3 - 3. Fig. 4 is a cross-section of an embodiment of disposable fluid collection apparatus of Fig. 2 taken at 4 - 4.

Fig. 5 is a perspective view of the disposable fluid collection apparatus wherein the embodiment is shown being folded for disposal.

Fig. 6 is a perspective view of an embodiment of the disposable fluid collection apparatus.

Fig. 7 is an exploded perspective view of an embodiment of a fluid collection apparatus.

Fig. 8 is a perspective view according to Fig. 7 wherein the disposable fluid collection apparatus is folded for shipping, storage, or disposal. Fig. 9 is a section detail of an embodiment of the disposable fluid collection apparatus of Fig. 7 taken at 9-9.

Fig. 10 is a section detail of the disposable fluid collection apparatus of Fig. 7 taken at 9-9 wherein the article is folded.

Fig. 11 is an exploded perspective view of an embodiment of a fluid collection apparatus.

Fig. 12 is a bottom view of the disposable fluid collection apparatus base depicted in Fig. 11.

Fig. 13 is a perspective view of an embodiment of the fluid collection apparatus viewed from a corner of the apparatus Fig. 14 is a perspective view of the apparatus embodiment of Fig. 13 viewed from the center of one side.

Fig. 15 is a detailed perspective view of a corner of the apparatus embodiment of Fig. 15.

Fig. 16 is a perspective view f the bottom surface of the apparatus embodiment of Fig. 13.

Fig. 17 shows an exploded perspective of an embodiment of a fluid collection apparatus viewed from a side of an operating table wherein an extension of a surgical drape is affixed to and between the upper surface of a floor-contacting foam polymer wedge base and the lower surface of a non- woven mesh pad. Fig. 18 shows the fluid collection apparatus of Fig. 17 fitted to an operating table viewed from a location behind the normal position of a surgeon and in which the surgical drape is configured to extend a splash barrier substantially beyond the end of the operating table.

Fig. 19 shows an embodiment of the fluid collection apparatus fitted to an operating table showing a surgical drape and fluid removal from multiple drainage ports.

DETAILED DESCRIPTION

The construction of a fluid collection apparatus for surgical procedures may be understood viewing the embodiments shown in accompanying Fig. 1 through Fig. 19. Fig. 1 shows, in perspective, an embodiment of a disposable fluid collection apparatus comprising a generally broad, shallow, vessel 20 to be removably positioned on an operating room floor, the vessel having a foldable sloping floor contacting floor region 22 having at least one portion to direct fluid toward a collection zone lower than the other portions of the floor region 22; a drain portion 24 to provide a fluid passage to drain fluid from the collection zone, a foldable wall 26 peripherally surrounding the floor region 22, and a non-absorbent, non-woven, foldable mesh pad 28 at least partially enclosed by the wall 26 and positioned above the floor region 22. Wall 26, retains nonabsorbent mesh pad 28 which is fitted within the wall 26 of the vessel and overlies floor region 22 of the vessel 20. In an embodiment, the nonabsorbent mesh pad 28 may be a non-woven, textile fiber mesh, an open-cell polymer foam. In another embodiment pad 28 is any mesh structure that prevents or reduces fluid splatter, has a high proportion of void space, and that has low fluid retention. Because the pad is not fluid retaining, it desirably is not slippery, even after fluid has spilled upon and passed through it. It provides a suitable traction surface upon which a surgeon and others of a surgical team may stand during surgery. Pad 28 is also generally flexible so that it can be folded and unfolded while to return to substantially return to its unfolded shape along with the remainder of the vessel 20.

In an embodiment, surgical drape 29, is affixed to the fluid collection apparatus 20. A lower end of drape 29 may be attached a portion of an inside edge of wall portion 26 of the vessel, along the side of the apparatus that is positioned closest to the edge of the operating table. The upper end of drape 29 is placed on the operating table under or adjacent to the patient to catch and direct fluid spilled during surgery to the vessel 20. In an embodiment, the lower end of drape 29 is attached along the end and portions of the adjacent side portions of wall 26. In an

embodiment such a configuration can effectively channel substantially all of the fluid discharged during a surgical procedure into the fluid collection apparatus 20.

Fig. 2 is an exploded perspective view of a double bi-fold embodiment 30 of a disposable fluid collection apparatus 20. It can be seen that, in an embodiment, the drain portion 24 includes a tubular portion 31. In an embodiment bulkhead feed-through fitting 31 couples vessel 20 and tubing 32 to convey fluids that enter the vessel to a collection container (not shown). House vacuum, a separate conventional vacuum pump or a small liquid pump may be used to convey fluids from the collection apparatus through the drain 24 and into the collection container. The floor region 22 of the vessel 20 is inclined to direct the flow of liquid across the floor of the vessel toward the collection zone adjacent drain 24. m an embodiment, drain channels 34 are formed in the bottom portion 22 of the vessel to direct fluids toward the drain 24 and to reinforce the vessel structure, hi an embodiment the floor region slopes from the sides to a central points 35 which are lower than the edges of the floor region. Fluid then flows from central points 35 through drain channels 34 to the collection zone adjacent the drain provided by bulkhead feed-through port 31. Channels 34 slope downwardly from points 35 to port 31.

In bi-fold embodiment 30, shown in Fig. 3, the floor contacting region 22 is divided into separate sections 36 and 38 by a center hinge portion 40. In an embodiment a hinge 40 may be provided to couple section 36 and 38. In an embodiment, hinge 40 is a molded feature of the floor region. In an embodiment, each section of the floor region is further divided into a first part 42 and a second part 44 that are connected by a further bottom hinge 46 which is also a molded feature of the floor region. The mesh pad 28 comprises two separate portions conforming to sections 36 and 38 of floor region 22.

Fig. 3 is a cross-section of an embodiment of disposable fluid collection apparatus 30 taken at 3 - 3 of Fig. 2 showing the mesh pad 28 and the vessel's floor region 22 in greater detail. Floor region 22 is shown sloping from the wall 26 to a central collection regions 35, shown in the center of the bottom portion in this

embodiment. In an embodiment, the wall 26 has a molded floor-contacting external edge region 48.

In an embodiment, region 48 receives suitable adhesives, surface treatments, materials or finishes that impart desired physical properties, such as increased slip resistance, to the fluid collection apparatus 20. An outer wall face 50 is connected by a top portion 52 to the inner wall portion 54 of wall portion 26 which bounds the floor panel 22.

Panel 22 has an upper surface 58 that slopes to a low point 35 where fluids accumulate prior to passage through drain channels 34 for removal to the collection zone adjacent to drain 31. hi an embodiment the low point 35 may be in the center of the panel 56. hi another embodiment , low point 35 is at another convenient location. In an embodiment spacers 62, are situated below panel 22 to support outer peripheral areas of the panel 22 and assist in maintaining a desired fluid draining slope. Fig. 4 is a cross-section of an embodiment of the disposable fluid collection apparatus of Fig. 2 taken at 4 - 4 showing a tubular conduit 64 positioned in a drain channel 34. When present, the conduit 64 extends from the location of low point 35 to bulkhead feed-through 31. Conduit 64 is fitted into channel 34. It may be secured in place by adhesive or mechanical fasteners. In an embodiment, conduit 64, allows fluid to be removed from low point 35 when it is coupled through feed through port 31 to a suction source.

Channel 34 can also provide a gravity driven fluid flow path from low point 35 to the collection zone adjacent port 31 as long as the collection zone is lower than low point 35. Fig. 5 is a perspective view of an embodiment of the disposable fluid collection apparatus 30 wherein the apparatus is shown partially folded for disposal. The functions of the center hinge 40 and of further hinges 46 are clearly revealed in Fig. 5. It is to be appreciated that the fluid collection apparatus 30 can be quickly and easily folded for initial shipping and storage and following use so that the entire article will fits into a conveniently sized disposal container.

Fig. 6 is a perspective view of a surgical drape-equipped embodiment 66 of the disposable fluid collection vessel wherein a surgical drape 29 is affixed to the fluid collection apparatus to direct all fluid from the operating table to the toward the vessel. In an embodiment a drain 24 configuration is depicted wherein each section 36 and 38 is fitted with a bulkhead fitting 31. A "Y" connector 68 is used to connect both of the bulkhead fittings 31 to the conduit 32 that conveys fluids to a collection container.

Fig. 7 is an exploded perspective view of an embodiment 70 of a fluid collection apparatus. In an embodiment, a separate drain base 71 may support a disposable fluid collection insert 70 that has an extended drain inlet 72 at the center of a long edge of each rectangular bottom part 42, 44 of the island. In an embodiment, the drain base 71 is integral to the disposable fluid collection insert 70. It is to be understood that many embodiments of the subject matter disclosed herein can provide a fluid collecting drainage system that can enable surgery to be performed in rooms that lack floor drains. That is particularly true in the configuration disclosed in Fig. 7 which provides a substantial structure for securely retaining lightweight, disposable fluid control inserts 70 that may be replaced following each patient surgery.

It is also possible that the article disclosed herein, in any of the disclosed embodiments and their equivalents, will serve as a fluid drainage system in place of floor drains because the disposable drain system 20 removes the fluids from the operating room for proper disposal (e.g., incineration) rather than as ordinary sanitary waste.

In an embodiment, the bottom portion 22, including the peripheral edge 26, may be formed of solid foam material rather than from sheet foam material.

Although this method of construction uses more material and is more costly as a result, the use of firmer material allows a steeper gradient on the upper surface 58 of the bottom panel as shown in Fig. 9 for example. Conduit extensions 64 reach the center of the junction of the first 42 and second 44 parts of floor contacting region 22.

In an embodiment shown in Fig 7 , solid foam dividers 74 are positioned between each rectangular first part 42 and second part 44. This type of construction may be selected, among other times, when it is desired to make the outer wall 50 angle gradually from the floor surface to the top of the peripheral edge 52. Fig. 5 is a perspective view of an embodiment wherein the disposable fluid collection apparatus 70 is folded for shipping, storage, or disposal.

In an embodiment shown in Fig. 7, dividers 74 may include a slot 76 and a filter block 78 near the center drains 72 to permit fluids to flow from the distal side 42 and be evacuated. In an embodiment the filter block 78 may be made from the same mesh as the pad 28 or other materials.

Fig. 9 is a section detail of the disposable fluid collection apparatus 70 of Fig. 7 taken at 9 - 9 depicting one of the lateral, or bottom, hinges 46, drain 72, and filter block 78. In an embodiment, the mating face of the distal portion 80 can be brought into substantially abutting contact with the mating face of the medial portion 82. However, the faces 80 and 82 need not actually touch to obtain satisfactory operation of the fluid collection apparatus 70 because the center drains 72 withdraw fluids that might flow into the gap between the faces. An overlap 84 may be included to divert fluids from the vicinity of the faces 80, 82 and toward the upper surface of the bottom 58 that is sloped toward the drains 72. Fig. 10 is a section detail of an embodiment of the disposable fluid collection apparatus 70 of Fig. 7 taken at 9 - 9 wherein the article is folded as shown in Fig. 8. The mating relationship among the slot 76, the filter block 78 that fits into the slot, and the overlap 84 are readily seen in this figure.

Fig. 11 is an exploded perspective view of a sheet-formed embodiment of the folding disposable fluid collection apparatus 86. In an embodiment the bottom portion 22 is vacuum formed from stock comprising 1/8" polymer such as a closed cell low density polyethylene foam. In some embodiments other non-absorbent materials are used, such as sheet metals, sheet plastics, and composites. In some embodiments use of closed-cell foam has the advantages of being light-weight, non- absorbent, relatively inexpensive, and readily disposable.

Vacuum forming is relatively inexpensive for short production runs. However, the product might be made in an embodiment using injection molding, particularly if production runs are longer.

The sheet-formed embodiment 86 is shown in Fig. 11 is formed with an optional toe-board 88 that allows a surgeon to re-position the fluid collection apparatus effortlessly during a procedure. Insets 90 stiffen the peripheral edge to better retain the pads 28. However, the bottom 22 is sufficiently resilient to collapse under the weight of a person's foot, a chair or cart wheel, or similar items, then return to the original position when the load is removed. Since the sheet-formed fluid collection apparatus 86 is not intended to support any load when in use, it is believed advantageous to allow it to deform when a load is applied to reduce the likelihood that the load will be tipped or unbalanced.

It can be seen in the embodiment shown in Fig. 11 that the upper surface 58 of the bottom is inclined toward the drain 24. The inclination may be maintained by one or more sets of ridges 92 and valleys 94. The ridges 92 support the pad 28 above the upper surface 58 of the bottom to reduce fluid retention in the island. A center dividing ridge 96 has shoulders 98 for supporting the edges of the pad 28 at the same plane as the ridges 92. Flow directing features such as valleys 94 make channels to direct fluid toward the drain 24 and contact the floor to support the upper surface 58 and maintain the desired inclination.

Fig. 12 is a bottom view of the disposable fluid collection apparatus 86 base depicted in Fig. 11. The floor-contacting portions of the insets 90 and valleys 94 formed in the bottom 22 can be readily seen in this view. In addition, the bulkhead feed-through 31 is easily viewed. Figs 13-16 illustrate an embodiment of the fluid collection apparatus. Figs.

13 and 14 are perspective views from two vantage points showing surface details of the surface of an embodiment of bottom floor region 22. m an embodiment the bottom portion is molded from a flexible foam. A feed through 31 passes through the vessel wall and provides a fluid path from a collection zone 130 to tubing and a collection container (not shown). As can best be seen in Fig. 15, the floor region 22 slopes from the rear wall forwardly toward collection zone 130 to facilitate flow of

received fluid along parallel channels, several of which are marked with reference character 134. In an embodiment, channels 134 drain into peripheral channels 140 which in turn drain into collection zone 130.

In an embodiment shown in Figures 13-16 the bottom portion 22 (and the mesh portion 28 which is not shown in these figures to allow the floor details to be seen) are foldable along hinge lines 136 which facilitate folding by edge cuts and molded hinge features. In an embodiment, a number of surface features 137 are provided across the bottom portion to support the mesh pad (not shown) above the surface of the vessel to facilitate free movement of collected fluids through the pad and across the surface of the vessel and, in part, through channels 134 to the fluid collection ports from which it is removed.

As shown in Fig.17, in an embodiment, a surgical drape 29 is attached proximate the periphery of any embodiments of the vessel so as to convey fluids from an operating table to the vessel. The non-woven mesh or open-cell foam pad 28 may conveniently be placed into the vessel 22 after the drape 29 has been attached, hi an embodiment, it is advantageous to affix the lower edge of the drape to the inner vessel peripheral wall 54 on the side of the vessel that will be closest to the operating table. hi an embodiment, the drape 29 extends several inches along the vessel ends, perpendicular to the side of the vessel closest to the operating table, so as to channel fluids that run from the operating table and patient into the fluid collection apparatus.

In an embodiment, adhesive portions may be incorporated onto the surgical drape 29 to retain the drape on the operating table and to hold other drape elements in their desired configuration.

Fig. 17 is an exploded perspective view of a further embodiment 106 of a fluid collection apparatus viewed from a location at the side of an operating room table wherein an extension of an extended surgical drape 108 is affixed to and between the upper surface of a floor-contacting foamed polymer wedge base 110 and the lower surface of a non- woven mesh pad 28. The surgical drape extension 107 thereby forms a continuous fluid-collecting surface that traverses the space

from beneath the patient and the bulkhead fitting 31. It is also possible to use adhesives, mechanical fasteners, heat sealing, or other means to shape the edges of the first end of the drape extension 107 into a structure that fulfills the fluid- retaining function of peripheral edge 26 of the embodiments. The extended edges 112 of the drape may be folded up the edges of the mesh pad 28 to prevent fluids from dispersing laterally away from the collection island 106. The drape extension 107 and drape 108 may be any convenient polymer film such as a 2 mil polyethylene material having any convenient dimensions for the procedures conducted. In an embodiment, a nylon or other polymeric feed-through fitting 31. The floor-contacting lower side of the polymer foam wedge 110 may optionally have anti-skid material 114 applied in situations where foot traffic may occur. The polymer foam wedge 110 may be any convenient material such as polyurethane or other low-cost material. Dimensions of this embodiment would be similar to those of other alternative embodiments previously described with a sufficient wedge gradient to cause fluid to flow to the feed-through 31 for collection (e.g. 1/2" per foot). A depression or cut-out 115 may be included to facilitate fluid collection by allowing the bulkhead fitting 31 to rest at the lowest point of the inclines created by supporting the drape material from the foam wedge 110 and operating table. Stiffening or shaping members 116 of elastic or springy material may be applied to enhance the fluid-collection functionality and stability of the drape 108. Heat-sealing or adhesives may be used to attach the drape extension 107 to the polymer foam wedge 110 and the mesh pad 28.

Although the drape extension 107 and drape 108 are depicted as formed integrally from a single sheet of plastic film, it is to be understood that either or both may be configured differently without departing from the invention. For example, the drape extension 107 might be formed to attach to the back of a conventional surgical drape 108 or to fit to a permanent fluid-guiding sluice affixed to an operating table. Likewise, it is possible to make this embodiment using different materials for the drape extension 107 and drape 108. Fig. 18 shows the fluid collection apparatus 106 of Fig. 17 fitted to an operating table viewed from a location behind the normal position of a surgeon and

in which an integral combination drape extension 107 and surgical drape 108 is configured to extend a splash barrier substantially beyond the end of the operating table.

It is anticipated that the foam wedge 110 would, in most instances, have very low density such that objects such as feet or instrument stands would compress the foam sufficiently to force the drape extension 107 nearly to the elevation of the floor. It is anticipated that the incremental amount of fluid retained by the embodiment 106 due to the presence of a person standing on the mesh 28 would be negligible and would flow freely toward the drain feed-through 31 as soon as the person moved. To reduce any tendency for fluids to pool where a person may stand, it would be possible to include stiff, rod-like members disposed on the top side of the drape extension 107 below the mesh 28 perpendicular to both the narrow and the wide edges of the wedge 110 such that the weight of a person's foot would compress the foam wedge below the rod-like member, thereby forming a channel in the top side of the drape extension 107 that runs adj acent the rod-like member toward the narrow edge of the wedge 110.

It is possible to make the wedge 110 from any material or with any degree of stiffness or resilience. For example, the wedge could be made of wood, fiberboard, polystyrene, metal, etc., without departing from the scope of the invention disclosed here. It would also be possible to make the wedge 110 from any density of resilient or rigid foam. For example, it would be possible to make the wedge using expanded polystyrene bead board equivalent to the low-density resilient foam believed preferable at the present time.

Likewise, it is possible also to form an embodiment with multiple drain elements. Such drain components could be comprised of at least one vacuum. drain tube 122 affixed to ports 120 formed through the wall of the collection. The ports are connected to vacuum drain tube 122 so that fluids entering it could enter and then be conveyed toward the vacuum source and trapped in collection canisters 104. A vacuum conduit extensions 122 could connect at either end or along the length of such a vacuum drain tube as shown in an embodiment as shown in Figure 19.

Changes and modifications in the specifically described embodiments can be carried out without departing from the scope of the invention which is intended to be limited only by the scope of the appended claims.