Disposable urology drainage bag

A urology drainage bag system has disposable clamps and/or bands that are disposed of along with the disposable urology drape. The drape, clamps, and band may comprise an integrated system for disposal as a unit. In some embodiments, the drape, clamps, and band are assembled together at the time of manufacture and sold as an integrated unit such that assembly of the drape onto the band by the end users at the point of use is not needed. Several plastic molded clamp embodiments are disclosed. Alternative methods and devices for supporting a flexible band and drainage bag relative to an OR table are also disclosed.

BACKGROUND

The present disclosure relates to disposable urology drainage bags and particularly, to urology drainage bags that attach to surgical tables. More particularly, the present disclosure relates, in large part, to urology drainage bag systems having devices that clamp onto the accessory rails of surgical tables.

Urology drainage bags that collect fluids during urological procedures are known. For example, Allen Medical Systems, Inc. markets the URO CATCHER® system, model number O-UC4 that can be used with URO CATCHER drapes, model numbers 0-UC31 and O-UC32, and with Brachytherapy drapes, model numbers A-50007 and A-50008. While the drapes are disposable, the URO CATCHER® system includes reusable accessory rail clamps and a flexible band that interconnects the clamps. Before re-use, the clamps and band are cleaned and may be sterilized. Furthermore, when not in use, the clamps and bands of the prior art URO CATCHER® system need to be stored somewhere.

SUMMARY

According to this disclosure, a urology drainage bag system has disposable clamps and/or bands that are disposed of along with the disposable urology drape. The drape, clamps, and band may comprise an integrated system for disposal as a unit. In some embodiments, the drape, clamps, and band are assembled together at the time of manufacture and sold as an integrated unit such that assembly of the drape onto the band by the end users at the point of use is not needed.

A disposable drainage bag system may include a drainage bag, a band coupled to and supporting the drainage bag, and a rail clamp. The rail clamp may include an upper jaw configured to engage the accessory rail of the surgical table and a slot sized to receive the band.

In some embodiments, the rail clamp may also include a protrusion extending into the slot. The band may be formed to include a hole extending through the band and configured to receive the protrusion when the band is received in a predetermined position in the slot.

The clamp may include a lower platform formed to include a threaded hole and a threaded knob engaging the threaded hole. The clamp may include a protrusion extending into the slot. The lower platform, the upper jaw, and the protrusion may form a monolithic clamp body. In some embodiments, the clamp may include a lever and the protrusion may extend out from the lever. The lever may be movable between a locked position wherein the protrusion extends through the band blocking the band from being removed from the slot and a released position wherein the protrusion is moved out of the slot so that the band can be removed from the slot. The clamp may also include a lower jaw movable relative to the upper jaw to clamp the accessory rail between the upper jaw and the lower jaw.

In some embodiments, the lower jaw may be moved between the open position and the closed position by the threaded knob. The lower jaw may pivot about a jaw axis to move between the open and the closed position.

The upper jaw, the lower platform, and the lower jaw may cooperate to form a monolithic clamp body. The clamp body may include a living hinge defining a jaw axis about which the lower jaw pivots. The clamp body may be formed from a plastics material.

In some embodiments, a clamp for coupling a drainage bag and a band to a surgical table having an accessory rail is disclosed. The clamp may include a beam, an upper jaw extending from the beam, a lower platform extending from the beam and formed to include a threaded hole, and a threaded knob. The threaded knob may engage the threaded hole of the lower platform. The knob may be rotatable to advance an end of the threaded knob toward the upper jaw and to clamp the upper jaw against the accessory rail.

The clamp may be formed to include a slot extending through the clamp and sized to receive the band. The clamp may include a protrusion extending into the slot and configured to locate the band at a predetermined position when the band is received in the slot. In some embodiments, the protrusion may be selectively pivotable out of the slot. The beam, the upper jaw, the lower platform, and the protrusion may form a monolithic clamp body.

The clamp may include a lower jaw and a rail opening may extend between the upper jaw and the lower jaw. The lower jaw may be pivotable about a jaw axis defined by a living hinge.

It is also contemplated that a clamp for coupling a drainage bag to a surgical table having an accessory rail may include a beam, an upper jaw extending from the beam, a lower jaw connected to the beam by a living hinge. The beam, the upper jaw, and the lower jaw may be formed as a monolithic clamp body. The lower jaw may be moved relative to the beam to clamp the accessory rail between the upper and lower jaw.

In some embodiments, the clamp may also include a threaded knob configured to move the lower jaw from the open position to the closed position. The monolithic clamp body may include a lower platform formed to include a threaded hole sized to receive the threaded knob

In many of the disclosed embodiments, it is contemplated that the clamps are molded from a plastics material. Some of the clamp embodiments have living hinges that permit clamp portions to fold around the accessory rails of surgical tables. Some of the clamp embodiments have separate plastic pieces that attach together to encompass some or all of the accessory rails. Some of the clamp embodiments have a first piece with a serrated or barbed protrusion, for example, that extends into a hole, recess, pocket or cavity of a second piece to attach the first and second clamp pieces together. Alternative methods and devices for supporting a flexible band and drainage bag relative to an OR table are also disclosed.

DETAILED DESCRIPTION

An illustrative disposable urology drainage bag system10includes a drainage bag12, a flexible support band14, a first clamp16, and a second clamp18as shown inFIG. 1. Drainage bag system10is configured to be used with a surgical table20having accessory rails22. Drainage bag12is supported and held open by flexible support band14during surgery. Flexible support band14supports drainage bag12as shown, for example, inFIG. 1. Clamps16,18are coupled to flexible support band14and clamps16,18clamp on to accessory rails22of surgical table20to couple drainage bag system10to surgical table20during surgery.

Illustratively, drainage bag12is constructed from a flexible sheet of plastics material. Drainage bag12includes a reservoir portion24, a sleeve portion26, and a flap28as shown inFIG. 1. Reservoir portion24is situated near and contacts an edge29of surgical table20as shown inFIG. 1. Sleeve portion26wraps around flexible support band14and couples drainage bag12to flexible support band14. Flap28extends over surgical table20so that fluids are blocked from contact with surgical table20.

Flexible support band14is operable to support and to hold open reservoir portion24of drainage bag12as shown inFIG. 1. Flexible support band14is flexible in the horizontal direction and is semi-rigid in the vertical direction. On account of its flexibility in the horizontal direction, flexible support band14is operable to flex in response to a surgeon or other caregiver contacting flexible support band14so that the surgeon or caregiver is not blocked from approaching the surgical table20by the drainage bag system10. Flexible support band14is illustratively made from a disposable or recyclable plastics material. However, in other embodiments, flexible support band14may be made from other materials.

Reservoir portion24of drainage bag12collects and directs fluids toward a waste storage system30. Reservoir portion24is coupled to waste storage system30by a tube32. In the illustrative embodiment, a mesh screen34is situated in reservoir portion24to block solid waste, dropped tools, or other non-liquid items from being directed to waste storage system30. In other embodiments, no mesh screen is used.

Clamps16,18are substantially similar and the following description of clamp16applies to clamp18. Clamp16includes a clamp body36and a threaded knob38as shown inFIG. 3. Illustratively, clamp body36is monolithically formed from a plastics material that is readily disposable or recyclable. Threaded knob38includes a head40and a threaded portion42as shown, for example, inFIG. 3. Threaded knob38is illustratively constructed from a plastics material that is readily disposable or recyclable.

Clamp body36is illustratively formed to include a beam44, an upper jaw46, a lower jaw48, and a lower platform50as shown inFIG. 4. Upper jaw46extends from a top end51of beam44. Lower jaw48is coupled to beam44by a living hinge52defining a jaw axis48A shown inFIG. 3. Lower platform50extends from a bottom end53of beam44and is formed to include a threaded hole54sized to engage with the threaded portion42of threaded knob38. Lower jaw48is situated between upper jaw46and lower platform50and an opening57is formed between upper jaw46and lower jaw48to receive accessory rail22as shown inFIGS. 4 and 5.

Lower jaw48of clamp body36moves between an open position, shown inFIG. 4, and a closed position shown inFIG. 5. When lower jaw48is in the open position, clamp16is free to slide on to and along accessory rail22. When lower jaw48is in the closed position, upper and lower jaws46,48are clamped on to accessory rail22as shown inFIG. 5. Lower jaw48is biased toward the open position by living hinge52as suggested inFIG. 4. To move lower jaw48from the open position to the closed position, a user rotates threaded knob38so that threaded knob38moves through lower platform50toward upper jaw46as suggested by arrow38A inFIGS. 4 and 5. Threaded knob38engages lower jaw48as it moves toward upper jaw46and causes lower jaw48to pivot about jaw axis48A as suggested by arrow48P shown inFIGS. 4 and 5. To move lower jaw46from the closed position to the open position, a user rotates the threaded knob38to move threaded knob38away from upper jaw46. When threaded knob38is moved away from upper jaw46, lower jaw48moves away from upper jaw46.

Beam44of clamp body36is formed to include a slot55and a protrusion56as shown, for example, inFIG. 3. Slot55is sized to receive flexible support band14. In the illustrative embodiment ofFIGS. 1-5, slot55is in communication with opening57configured to receive accessory rail22. In other embodiments, slot55may be independent from opening57. Protrusion56is configured to be received in a hole58formed in flexible support band14to locate flexible support band14in clamp16when flexible support band14is received in slot55.

Another embodiment110is shown inFIG. 6in which a flexible band112is secured to lower sections or portions114of a pair of rail clamps116which also have an upper section or portion118. The upper and lower portions114,118of the pair of rail clamps116are separable into two pieces that selectively attach to one another that detach from one another. In the illustrative example, band112is removed along with the lower section114of the rail clamps. Clamps116attach to accessory rails120of an OR table or surgical table122. An embodiment210in which a flexible band212is detachable from associated rail clamps216is shown inFIG. 7.

A flexible band312has its opposite ends integrated with a respective clamp316of a pair of rail clamps316as shown in the embodiment310ofFIG. 8. The clamps316are mounted to accessory rails320of a surgical table322. In this example, the flexible band312has side portions that are squeezed or flexed inwardly toward another in the direction of arrows313to snap the clamps316off of the accessory rails320in the directions of arrows315.

An embodiment510in which a rail clamp516has a larger, first channel524sized to receive an accessory rail (not shown inFIG. 9) of a surgical table and a smaller, second channel526sized to receive an end of a flexible band512is shown inFIG. 9. An end513of flexible band512is arranged for insertion into the second channel526. The end513is held in channel526by an interference fit in some embodiments. In other embodiments, end513is adhered to clamp516such as by heat (e.g., RF or sonic welding) or by using an adhesive material (e.g., glue or cement). In an alternative embodiment610, shown inFIG. 10, an end613of a flexible band612is adhered to a vertical wall615of a rail clamp616via heat or adhesive material. Thus, clamp616ofFIG. 10is similar to clamp516ofFIG. 9except that the structure of the clamp516forming channel526is omitted in clamp616.

Referring now toFIG. 11, an embodiment710of a rail clamp716has two clamp halves714,718each of which has a groove721that receives upper and lower edge regions723,725of a flexible band712with the flexible band situated in the same channel724of the accessory rail clamp716that receives an accessory rail (not shown inFIG. 11) of a surgical table (not shown inFIG. 11) such that a portion of the flexible band712will be adjacent the accessory rail.

Referring now toFIG. 12, an embodiment810includes a flexible band812having a through hole813and a rail clamp816having a post817protruding from a vertical wall815of rail clamp816. Rail clamp816also has an L-shaped corner locator819protruding from the vertical wall815. A corner827of band812nests within the corner locator819and post817is received in hole813when band812is attached to clamp816. In some embodiments, post817has a slightly enlarged head that snaps through hole813when band812is being attached to clamp816or detached from clamp816. In other embodiments, the end of post817may be staked or headed to enlarge the end of post817by a sufficient amount after band812has been attached to permanently attach band812to clamp816.

FIG. 13has five views, labeled A-E, showing an end region of five different flexible bands1012a-1012eeach having a different tab shape. The topmost view with will be referred to as the first view ofFIG. 13and the bottommost view will be referred to as the fifth view ofFIG. 13with similar numerical designators from top to bottom ofFIG. 13. In the first view ofFIG. 13, band1012ahas a notch1013aalong its top edge1023asuch that a generally square-shaped tab portion1018aof band1012ais defined next to a necked down portion1026aof band1012a. In the second view ofFIG. 13, band1012bhas an undercut notch1013balong its top edge1023bsuch that a barbed tab portion1018bof band1012bis defined next to a necked down portion1026bof band1012b. Barbed tab portion1018bhas an arcuate upper edge1019b. In the third view ofFIG. 13, band1012cis substantially similar to band412ofFIG. 4and has a rounded tab1018cnext to a necked down portion1026c. Notches1013cand1015care provided in an upper edge1023cand bottom edge1025cof band1012cto define necked down portion1026c. Tab1018chas a diamond shaped opening1017c.

In the fourth view ofFIG. 13, band1012dhas a spade shaped tab1018dnext to a necked down portion1026d. Notches1013dand1015dare provided in an upper edge1023dand bottom edge1025dof band1012dto define necked down portion1026d. Tab1018dhas a somewhat diamond shaped opening1017d. In the fifth view ofFIG. 13, band1012ehas a rounded tab1018enext to a necked down portion1026e. Notches1013eand1015eare provided in an upper edge1023eand bottom edge1025eto define necked down portion1026e. Tab1018ehas a horizontal slot1017eprovided along a longitudinal centerline of band1012e.

FIG. 14has twelve views, labeled A-L, showing cross sections of different rail clamps1116A-1116L contemplated by this disclosure with each of the different rail clamps being attachable to a standard-sized accessory rail1100of a surgical table. Clamp1116A has an upside down U-shaped upper jaw portion1118A and an upwardly inclined lower jaw portion1120A. Clamp1116B has an upside down V-shaped upper jaw portion1118B and a V-shaped lower jaw portion1120B. Clamp1116C has a downwardly inclined upper jaw portion1118C, an upwardly inclined lower jaw portion1120C, and a straight vertical wall1122C. Clamp1116D has an upside down U-shaped upper jaw portion1118D and U-shaped lower jaw portion1120D. Clamp1116E has an upside down U-shaped upper jaw portion1118E and an L-shaped lower jaw portion1120E.

Clamp1116F has a downwardly arced upper jaw portion1118F and an upwardly arced lower jaw portion1120F. Clamp1116G has an upside down L-shaped upper jaw portion1118G and an upwardly arced lower jaw portion1120G. Clamp1116H has an upside down U-shaped upper jaw portion1118H and a V-shaped lower jaw portion1120H. Clamp1116I has an upside down L-shaped upper jaw portion1118I with a downwardly inclined lip extension1119I and an L-shaped lower jaw portion1120I with an upwardly inclined lip extension1121I. Clamp1116J has an upside down L-shaped upper jaw portion1118J with a downwardly inclined lip extension1119J and a V-shaped lower jaw portion1120J. Clamp1116K has a tilted upside down V-shaped upper jaw portion1118K and a tilted V-shaped lower jaw portion1120K. Clamp1116L has an upside down tilted V-shaped upper jaw portion1118L and an L-shaped lower jaw portion1120L with an upwardly inclined lip extension1121L.

FIG. 15has two views, labeled A and B, showing cross sections of different flexible bands1212A and1212B contemplated by this disclosure. Band1212A has an upright solid rectangular cross section. Band1212B has an upright hollow rectangular cross section.

Referring now toFIG. 16, a urology drainage bag1300is attached to a roll-away cart1302. Bag1300and cart1302can be used in the place of a urology bag that is attached to an OR table. The cart1302has a base1304supported on a set of corner casters1306. Cart1302has a pair of upright A-frames1308extending upwardly from base1304on opposite side of cart1302. Urology bag1300has an integrated flexible band1312at its upper opening. Bag1300also includes a flap1301extending out from band1312and configured to overlie an end region of an OR table or table mattress (not shown). Portions of band1312attach to the upper ends of A-frames1308. A drainage hose1350extends from a bottom of bag1300to a fluid collection canister1352that is supported by base1304. Fluid collected in bag1300during surgery drains into hose1350through a bottom opening1310of bag1300A trash receptacle1354is also supported by base1304.

Referring now toFIG. 17, an embodiment1410has integrated clamps1416, flexible band1412, and urology drainage bag1400arranged for attachment to a pair of accessory rails1420at the end of an OR table1422in the direction of the pair of double arrows1423. A mesh screen1425is positioned in drainage bag1400to block non-liquids from exiting drainage bag1400. The integrated clamps1416, band1412, and bag1400are attached to the accessory rails1420of the OR table1422inFIG. 18. Also inFIG. 18, a flap1402of the drainage bag1400is shown moved to a position overlying an end region of an OR table mattress1407with a transition region1401of drainage bag1400interconnecting the flap1402and main bag portion of bag1400.

Referring now toFIG. 19, a user's hands are holding rail clamps2216of an integrated clamp2216, band2212, and drainage bag2200system2210in a position for generally simultaneous attachment of the clamps2216of the integrated system2210to accessory rails2220of an OR table2222. After attaching system2210to rails2220, the rail clamps2216of the integrated system2210are squeezed in the direction of arrows2204to secure the rail clamps2216to the accessory rails2220.

FIG. 20illustrates the general concept of removing a rail clamp2816from an accessory rail2820by sliding lower and upper rail clamp2814,2818portions horizontally in opposite directions, indicated by arrows2802, along the accessory rail2820to achieve separation of the rail clamp portions2814,2818for removal.

An embodiment3010in which a drainage bag3000is integrated with a flexible band3012via heat (i.e., RF or sonic welding) or adhesive material (i.e., glue or cement) is shown inFIG. 21. An embodiment3110in which a drainage bag3100is integrated with a flexible band3112by forming a pocket3102at a top region of the bag by using adhesive, heat seal, hook-and-loop type fasteners, or sewing, and then feeding the flexible band3112through the pocket3102is shown inFIG. 22. To complete the integrated embodiment3110, ends3113of the flexible band3112are attached to rail clamps3116, only one of which is shown inFIG. 22.

In theFIG. 23example, an integrated bag3300and band3312combination is separated from a pair of rail clamps3316for disposal.

Referring now toFIG. 24, a rail clamp3416has a top section3418with a downwardly extending toothed tab3450and a bottom section3414having a channel3452that accepts the toothed tab3450. Teeth3456of the toothed tab3450are ramped. A pair of ramped teeth3458are provided at the upper end of the channel3452for intermeshing with the teeth of the tab3450as shown best inFIG. 24. Rail clamp3416is clamped onto an accessory rail3420by inserting the toothed tab3450into an upper region of the channel3452and then vertical squeezing portions3414,3418together.

After the rail clamp3416is completely clamped onto the accessory rail3420, the toothed tab3450is fully ratcheted downwardly into the channel3452of the bottom section3414as shown inFIG. 36. To remove clamp3416from rail3420, portions3414,3418of clamp3416are slid horizontally in opposite directions along the accessory rail3420until portions3414,3418are slid horizontally by a sufficient amount to be separated from one another. Each of portions3414,3418of clamp3416has a finger tab3464that can be pressed or gripped by a user to facilitate the horizontal sliding movement of portions3414,3418.

Referring now toFIG. 25, a clampless system4010includes an integrated bag4000and band4012. To attach system4010to accessory rails4020of an OR table4022, ends4013of band4012are inserted (with the bag4000attached) generally vertically downwardly between the OR table4022and the accessory rails4020in front of standoffs4021of the accessory rail4020. Then, the band4012and bag4000are rotated in the direction of counterclockwise double arrows4002so that ends4013of the band4012catch onto a bottom of the rail standoffs4021. Further rotation of the band4012and bag4000thereafter cause a looped portion4015of the band4012to rest atop the accessory rail4020with a majority of the flexible band4012being held in a horizontal orientation.

As shown inFIG. 25, an upper edge4017of each end portion4013of band4012has a notch4019that receives the rail standoff4021when the system4010is mounted to OR table4022. A distal tab4018defined to the right of notch4019inFIG. 25prevents system4010from sliding horizontally off of the accessory rails4020when system4010is in use during a surgical procedure.

In the example ofFIGS. 26A-26C, an upside down U-shaped rail clamp5916has an inclined, inwardly projecting flange5902extending from one of a pair of vertical walls5904of the rail clamp. As clamp5916is moved downwardly in the direction of arrows5906onto an accessory rail5920, the inclined flange5902first contacts an upper left corner region of the accessory clamp5920(seeFIG. 26B). Further downward movement of clamp5916over accessory rail5920causes flange5902and the associated wall5904to flex outwardly. When clamp5916is fully inserted downwardly onto the accessory rail5930, the inclined flange5902extends beneath the accessory rail5920to retain the rail clamp5916on the accessory rail5920.

Referring now toFIGS. 27 and 28, a rail clamp7616has a molded clamp body7602that slips onto an end of an accessory rail7620and has a threaded knob7604that threads through a vertical wall7606of the clamp body7602. The tip of threaded knob7604projects through a hole7613(shown inFIG. 28in phantom) in a flexible band7612to engage a vertical surface of an accessory rail7620to mount the rail clamp7616and the flexible band7612to the accessory rail7620. Clamp body7602has stepped lower and upper jaws7614,7618with a first set of upper and lower shoulders7650(seeFIG. 28) defining upper and lower band receiving grooves adjacent the vertical wall7606of the clamp body7602and a second set of upper and lower shoulders7652(seeFIG. 28) defining rail receiving channels that receive the accessory rail7620. Retention tips7654are defined adjacent shoulders7654. Tips7654are adjacent a vertical surface of the accessory rail7620.

A drainage bag (not shown) couples to flexible band7612. Rail clamp7616is attached to an accessory rail7620of an OR table (not shown). Rail clamps7616and flexible band7612are attached to accessory rails7620of an OR table (not shown) and arrows7660show the rotational direction of tightening the threaded knobs7604so that knob7604is turned away from the user to secure the rail clamps7616to the rails7620. To accomplish this, the patient's left clamp7616has a clockwise thread and the patient's right clamp7616as a counterclockwise thread.

Referring now toFIGS. 29 and 30, a plastic coupler8402has an elongated post8404of X-shaped or cross-shaped cross section and a rectangular band receiving portion8406at the end of the elongated post8404. A flexible band attached to the rectangular band receiving portion8406via a press fit into a cavity8408of portion8406. A urology drainage bag8400attaches to the flexible band8412that has its ends attached to respective plastic couplers8402. The post8404of the plastic coupler8402is sized for press fit insertion into a horizontal socket8490provided in a frame member8492of an OR table8422as shown best inFIG. 30.

In theFIG. 31example, a flexible band9612has separate tips9613that are molded to include a rounded end9615and a through hole9617. Tips9613have band receiving pockets9650sized to receive the main band member with a press fit. In alternative embodiments, heat or adhesive is used to couple the main band member to tips9613.

Referring now toFIGS. 32-36, a reusable rail clamp9716has a lever9702attached to a main clamp body9704. Lever9702can be pushed to permit a flexible band9712to be detached from the rail clamp9716. Clamp9716has a vertically oriented threaded knob9706that can be tightened against the bottom of an accessory rail (not shown) to retain clamp9716on the rail. Lever9702has a protrusion9708(seeFIG. 35) that is received in a hole9713of band9712to retain band9712relative to main body9704of clamp9716. Lever9702can have a pocket9740(seeFIG. 38) or channel9742(seeFIG. 39) to indicate where a user should push on lever9702to pivot the lever9702about a pin9744.FIG. 35shows cross sections of reusable rail9716with clamp body9704having a spring9977biasing pivotable lever9702to a locking position in which a projecting pin9708at its upper end is received in the through hole9713of flexible band9712to retain the flexible band9712in place relative to the rail clamp body9704.

Although certain illustrative embodiments have been described in detail above, many embodiments, variations and modifications are possible that are still within the scope and spirit of this disclosure as described herein and as defined in the following claims.