2. Description of the Background Operating room tables which pivot or articulate to allow surgeons to place their patients in a particular position is suitable for a particular surgical or other procedure are well known in the art. Hall (U. S. Patent No. 4,865,303) describes one such table having a number of pivot points and pivot actuators which allow the table to pivot from end to end about a vertical plane (see Figs. 13 and 14). Many other tables, having similar features, are known in the art.

Over the years, physicians have found these tables to be useful when it is necessary to conduct surgical procedures which require the positioning of the patient in either a Trendelenberg's position or a reverse Trendelenberg's position. The Trendelenberg's position is generally employed in laparoscopy procedures in the pelvic region. In this position, the patient's pelvis is elevated above the patient's head so that the intestines are drawn away from the pelvis toward the upper abdomen. In a reverse Trendelenberg's position, the head is elevated above the abdomen allowing the intestines to fall toward the pelvis making it easier to conduct laparoscopic procedures in the upper abdomen. Common laparoscopic procedures conducted when the patient in is in a Trendelenberg's position include procedures in the pelvic region

involving the uterus, the ovaries, and other pelvic organs. Laparoscopic procedures directed to the upper abdomen which are generally conducted in the reverse Trendelenberg's position include procedures relating to the gall bladder, hiatal hernias, liver biopsies, lymph node sampling around the stomach and the upper aorta, and the like. Laparoscopic surgical techniques employing these positions were advanced during the late 1970s. When patients undergo procedures in the Trendelenberg's position, they are generally provided with a shoulder brace of one kind or another to support them and prevent them from sliding offthe table. The length of these procedures, as with most surgical procedures, is believed to influence the quantity and type of morbidity. Lengthy procedures where the patient is in a 20-40% Trendelenberg's position in shoulder braces, may provide unequal shoulder support or permit abduction of the arm to about 90° or more, and may also predispose patients to a variety of neurologic sequelae. One of the most common causes of post-operative upper extremity neuropathy is compression and/or stretching of the brachial plexus which can result from such a procedure (see, for example Romanowski, L. et al., Brachial Plexus Neuropathies After Advanced Laparoscopic Surgery, Fertility and Sterility, 1993,60 : 729-732; Westin, B, Prevention of Upper-Limb Nerve Injuries in Trendelenberg's position Acta Chire Scand, 1959,108,61-67; Wright, I. S., The Neurovascular Syndrome Produced by Hyper abduction of the Arms, AM. Heart J. 1949,29: 1-19; and Costly, D. O., Peripheral Nerve Injury, INT. Anesthesiol. Clin., 1972, Ken: 189-206.) It is believed that neuropathic injury, specifically brachial plexus injury, may persist as a relatively common operative complication unless the current generation of gynecological surgeons and other health care providers are familiar with both the etiology risk factors and preventive measures for brachial plexus stretch and/or injuries. A significant risk factor associated with laparoscopic

gynecological procedures conducted when the patient is in the Trendelenberg's position, as commonly practiced, is using pivotal surgical tables equipped with shoulder braces, harnesses or other devices designed to support or catch the subject's shoulders in order to prevent the subject from sliding off the table.

It will be appreciated, therefore, that improvements over the presently available surgical or operating room tables, which could minimize the frequency of brachial plexus neuropathies and other neuropathies associated with laparoscopic gynecological procedures conducted in the Trendelenberg's position, would be a welcomed contribution to medical practice, and that prior art operating room or surgical tables present problems which are in need of solution. The present invention provides solutions for these and other problems.

SUMMARY OF THE INVENTION The present invention is directed to a pivotal operating room table having a main surface and an elongated support member. The main surface preferably lies generally in a first plane and is pivotal end to end such that the first plane can pass through a second generally vertical plane as the main surface pivots to end to end. The second plane is generally perpendicular to the first plane. The elongated support member is adjustably interconnected with the operating room table, and provides a support surface lying generally in a third plane which is generally perpendicular to the second plane when the elongated support member is interconnected with the table. In preferred embodiments the elongated support member is adjustably interconnectable with the table at a plurality of heights above the main surface and it further includes an elongated support bar and an inflatable bladder resting above the elongated support bar. In preferred embodiments the operating room table will include a pair of elongated, parallel attachment bars on opposite sides of the main surface and interconnected with the main surface and generally

parallel thereto. The elongated support bar is adjustably interconnectable with each of the attachment bars. In alternate embodiments, the third plane may be oriented at an angle to the first plane, however, in preferred embodiments, such as those illustrated herein, the third plane will be generally parallel with the first plane. As will be appreciated, the support bar may also be adjustably pivotal so that the third plane can pivot with respect to the horizon in alternate embodiments.

In other embodiments, the present invention provides an elongated support attachment for attachment for a pivotal operating room table. The preferred support attachment includes an elongated support member interconnected to a pivotal operating room table at a number of heights above a main surface of the table. The elongated support member has a relatively hard underlying support surface and a relatively soft compressible overlying support covering above the underlying support surface. The overlying support covering preferably includes relatively soft support materials such that the overlying support covering can be compressed when bearing weight. The support materials preferably include an expandable bladder which can be inflated and deflated so as to contain varying amounts of air and to provide varying amounts of compressible cushioning capacity.

The present invention also provides methods of supporting a patient on a pivotal surface during a surgical procedure. In one embodiment, the method includes providing a pivotal operating room table having a main surface and an elongated support member adjustably interconnected therewith which provides an elongated support surface which can be adjustably secured relative to the main surface such that the main surface and the elongated support surface are fixedly oriented with respect to each other once the elongated support bar is secured relative to the pivotal main surface. The elongated support surface preferably has two edges on opposite

sides and the elongated support bar is adjustably secured relative to the main surface such that the elongated support surface is generally located above the main surface. This embodiment preferably includes positioning the patient supine on both the pivotal main surface and the elongated support surface such that the elongated support surface is in contact with the lower lumbar region of the patient's back; and orienting the pivotal main surface such that the patient's buttocks are elevated above the patient's head in a Trendelenberg's position; wherein the elongated support surface is positioned immediately below the lower lumbar region of the patient's back and the upper portion of the patient's buttocks rests at least partially against at least one of the edges of the elongated surface to resist gravitational forces biasing the patient in a generally downward direction. In preferred embodiments, the step of positioning includes inflating the bladder to permit the elongated surface to conform in part to the shape of the patient's back proximate the lower lumbar region of the patient's back where the elongated surface comes into contact therein.

In a further embodiment, the method includes positioning the patient supine on both the pivotal main surface and the elongated support surface such that the elongated support surface is in contact with a lower portion of the patient's buttocks; and orienting the pivotal main surface such that the patient's head is elevated above the patient's buttocks in a reverse Trendelenberg's position; wherein the elongated support surface is positioned immediately below the patient's buttocks and the lower portion of the patient's buttocks rests at least partially against at least one of the edges of the elongated surface to resist gravitational forces biasing the patient in a generally downward direction. In preferred embodiments, the step of positioning includes inflating the bladder to permit the elongated surface to conform in part to the shape of the

patient's back proximate the lower portion of the patient's buttocks where the elongated surface comes into contact therein.

It is an object of the present invention to provide a pivotal operating room table which will permit the physician to conduct a laparoscopic surgical procedure when the patient is in preferably either a Trendelenberg's position or a reverse Trendelenberg's position, while minimizing the chance of creating brachial plexus injuries due to brachial plexus stretching and/or compression.

These and various other advantages of novelty that characterize the present invention are pointed out with particularity in the claims and appended hereto and forming a part hereof. For better understanding of the present invention, however, its advantages and other objects attained by its use, reference should be made to the drawings, which form a further part hereof, and to the accompanying descriptive matter, in which there is illustrated and described preferred embodiments of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS The present invention will be described in connection with the accompanying drawings, in which the reference numerals refer to the same or similar parts of the respect embodiments: Fig. 1 A is a side view of a patient in a Trendelenberg's position on an operating room table of the present invention; Fig. 1 B is a side view similar to that shown in Fig. 1 A showing a patient in a reverse Trendelenberg's position on an operating table of the present invention which is similar to the table shown in Fig. 1A ; Fig. 2 is an enlarged perspective view of an elongated support member similar to that shown in Figs. 1A and 1B ;

Fig. 3 is an exploded perspective view of the elongated support member shown in Fig. 2; Fig. 4 is an end view of the elongated support member is shown in Fig. 2; Fig. 5 is a cross sectional view of the elongated support member shown in Fig. 2 as seen from the Line 5-5 of Fig. 2; Fig. 6 is a top plan view of the support bar shown in Fig. 3, with the attachment bars assembled; Fig. 7 is a partially cut away side view of the elongated support bar shown in Fig. 3 as seen from the line 7-7 of Fig. 3 ; Fig. 8 is a bottom plan view of the elongated support bar shown in Fig. 3 showing the attachment bar and the attachment bar receiving slot partially in phantom; Fig. 9 is a schematic representation of an alternate elongated support member attached to an operating room table and lying on the top of the main surface thereof ; the elongated support member is shown with the inflatable bladder in a deflated state, while the inflated profile shown in phantom ; Fig. 10 is a schematic view similar to that shown in Fig. 9, but showing the elongated support member in a raised position above and not in contact with the main surface of the operating room table; Fig. 11 is a further partial schematic view of an alternate operating room table having a separated main surface providing a recess for the elongated support member and showing the elongated support member in a deflated condition wherein the support surface of the elongated support member is flush with the main surface, while showing the inflated profile in phantom; and

Fig. 12 is a further partial schematic end view of the operating room table shown in Fig.

11 but showing the elongated support member in a raised orientation above the main surface of the operating room table and showing the elongated support member in an inflated state where the bladder has been inflated.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to Fig. 1 A, a pivotal operating room table 10 of the present invention is shown. A patient 12 is shown lying supine on the patient's back on the main surface 38 of the operating room table 10 in a Trendelenberg's position. The patient's buttocks 16 is elevated above the patient's head 18 and shoulders 19, and the patient's legs 20 are up in stirrups 22. The table 10 has elongated side rails 32 to which an elongated support member 34 is adjustably secured. The patient's back 14 includes the patient's shoulders 19 and the lumbar region 26, which includes the upper lumbar region 27 and the lower lumbar region 28, immediately adjacent the buttocks 16. Lower lumbar region 28 is engaged with an upper surface 36 of the elongated support member 34 prior to laparoscopic procedures in the pelvic region. Healthcare professionals can position the patient 12 supine on both the main surface 38 of the operating room table 10 and the upper surface 36 of the elongated support member 34 in preparation for laparoscopic surgical procedures. Preferably, the patient will be awake and relatively alert when the patient is first placed on the operating room table 10. The operating room table 10 will generally be in a horizontal orientation (not shown) when the patient is first positioned on the table 10. The elongated support member 34 may be already raised to a height above the main surface 38 believed to be sufficient to provide the necessary resistance to gravitational forces placed upon the patient, which would otherwise cause the patient to slide downward along the main surface 38 when the table is tilted to put the patient 12 in the Trendelenberg's position

shown in Fig. 1 A. Once anaesthesia is provided to the patient, the bladder 40, shown in Fig. 3 can be inflated using the bulb 42 and check valve 43 mechanism 41 which is similar to, and works in the same manner as, a bulb compression pump (not shown) of the type used in an arm cuff for taking blood pressure readings. It will be appreciated that other well known methods for inflating bladders may be used in substitution for this mechanism and that these mechanisms are well within the scope of the present invention.

Referring now also to Fig. 1B, a similar operating room table 10'is shown in which a patient 12'is shown in a reverse Trendelenberg's position wherein the patient 10'is in a supine position upon the main surface 38'and the patient's buttocks 16'is up against an edge 35'of the upper surface 36'of the elongated support member 34'.

Referring now also to Fig. 2-8, the preferred elongated support member 34, of Figure 1 A, having an outer encasement 46 is shown. The outer encasement is preferably made from a rubberized washable fabric which is soft to the touch and provides a non-sticky engagement surface on the elongated support member 34. In preferred embodiments, this washable fabric is made of a Super-soft Dartex cover material from the Dartex Corporation in the United Kingdom and available from Dynamic Systems, Incorporated, Leichaster, NC. This material is preferably impregnated with an antimicrobial agent or agents, is water impermeable up to 250 mmhg to keep extraneous fluids from entering the material As shown particularly in the exploded view shown in Fig. 3, a memory foam pad 48 and an inflatable bladder 40 are inserted within an open ended chamber 52 in the outer encasement 46. The outer encasement 46 is then assembled around a block material 54 which is secured to a pair of attachment bars 56 which are slidably engaged within attachment bar receiving slots 57

within the block material 54 and are secured with screws 58 in, the manner illustrated in Fig. 3.

The outer casement 46 is secured around the block material 54 once the memory foam pad 48 and the inflatable bladder 40 are inserted within the open-ended chamber 52. The outer casement 46 is secured to the block material 54 by a plurality of snap connectors 59 secured to an outer edge 47 of the outer encasement 46 which are disconnectably individually secured to a plurality of snap receiving screws 60 secured to the bottom side of 55 of the block material 54. A cross- sectional view of the elongated support member 34 is shown in Fig. 5 when the bladder 40 is fully inflated. The snap connectors 59 pass through connector openings 61 in the outer encasement 46 to connect with the snap receiving screws 60. The preferred Dartex cover material preferably stretches numerous directions to accommodate the expansion of an end view of the elongated support member 34 is shown in Fig. 4 when the bladder 40 is completely deflated and a cross-sectional view, showing one of the snap receiving screws 60 in phantom, is shown in Figure 5 where the bladder 40 is fully inflated. The preferred side rails 32 and the attachment bars 56 of the present invention are heavy gauge steel support bars made of stainless steel or any other suitable material which can provide the necessary support without breaking, bending or otherwise malfunctioning. In alternate embodiments (not shown) other metal materials, composite materials and even hardened polymeric materials and combinations thereof can be used for these parts.

The manner of attaching the attachment bars 56 to the block material 54 is illustrated in Figs. 3-8. The block material 54 is made of relatively hard material such as an inflexible polymeric material, composite materials, metals such as stainless steel wood or wood composites, and combinations of these materials, preferably ultra-high molecular weight UHMW plastic materials such as polyethylene, polycarbonate and the like which are very strong, yet

lightweight, inexpensive and easily cleansed. The insertion ends 66 of the attachment bars 56 insert into attachment bar receiving slots 57 in the respective ends 67 of the block material 54.

The respective attachment bar receiving slots 57 each have an upper slot 68 and a lower channel 69 in communication with the respective receiving slot 57. The head 71 of a catch screw 72 secured in a screw receiving opening 73 in the insertion end 66 of each attachment bar 56 acts to slidably retain the insertion end 66 of the attachment bar 56 within the receiving slot 57. In this way the length of the support member 34 is easily extended to adjust to differing widths to differing surgical tables (not shown). The attach the support member 34 to the operating room table 10, the attachment bars 56 are slidably adjusted within the receiving slots 57 so that the securing ends 65 of the attachment bars 56 can slide into securing clamps 75 on elongated side rails 32 of the operating room table 10. The clamps 75 are tightened to lock the support member 34 in place relative to the operating room table 10 such that the upper surface 36 of the support member 34 is secured in a position relative to a position of the main surface 38. The elongated support member 34 is secured to elongated side rails 32 using clamps 42 similar to that shown in Fig. 2, however, any known clamps will suffice to secure the support member 34 to the side rail 32 so long as the clamps grip both the attachment bars 56 and the elongated side rails 32 so that the support member 34 cannot be raised or lowered with respect to the main surface 38 or slide with respect tot eh side rails 32 once the clamps are tightened down to fully grip the attachment bars 56 and the side rails 32. Any well known clamp which will do this is well within the scope of the present invention.

In Figs. 9 and 10, schematic partial side views of an operating room table 10 like that shown in Fig. 1 A is provided. The elongated support member 34 is shown resting upon the main surface 36 of the operating room table 10 in Fig. 9 and the support member 34 is shown in an

inflated orientation only in phantom. In Fig. 10, the support member 34 is elevated above the main surface 36 and the bladder (not shown) is inflated. As discussed above, the support member 34 can be raised and lowered by loosening the securing clamp 75 to allow the attachment bars 56 to slide up or down with respect to the side rails 32 so as to position the upper surface 36 of the support member 34 at different relative heights (e. g. Xla, X2) above the main surface 38. As shown in phantom in Figure 9, raising the height of the upper surface 36 with respect to the main surface 38 can also be accomplished by inflating the bladder (not shown) within the outer encasement 46 of the elongated support member 34 (see Xlb).

In Figs. 11 and 12, an alternate operating room table 10"is shown having a recess 44 in which the elongated support member may reside as shown in Fig. 11 so that the upper surface 36"of elongated support member 34"may be flush with the main surface 38"when the elongated support member is in a deflated orientation. As in the other embodiment, the height of the upper surface 36"can be raised to a height X3 above the main surface 38"by inflating the inflatable bladder (not shown). As shown in Fig. 12, however, the elongated support member 34"may be raised and adjustably secured to the elongated side rails 32"to raise the upper surface 36"to a height X4 above the main surface 38". The support member 34"of the alternate embodiment shown in Fig. 12, preferably has all the elements of the support member 34 shown in Figs. 2-8 and the operating room table 10 has similar elements as well, with the addition of the recess 44"which creates a main surface 38 which is a split.

It will be appreciated that the preferred operating room tables 10,10', 10"shown in the drawings are pivotal so that the main surface 38, 38'and 38"can pivot end to end through a vertical plane consistent with the plane of the paper upon which the illustrations of the operating room table 10, 10', 10"are provided herein. In this way, the preferred operating room tables 10,

10', 10"can be pivoted in the manner shown in Figs. lA and 1B, respectively, to provide a main surface 38 lying in a first plane Al which is slanted to place the patient in a Trendelenberg's position (see Fig. 1 A) and to provide a main surface 38'lying in a second plane A2 which is slanted to place the patient in a reverse Trendelenberg's position (see Fig. 1B). In each case, the first and second planes A, and A2 are preferably perpendicular to the vertical plane in which the operating table 10,10', 10"and the main surface 38, 38', 38"pivot end to end.

It is to be understood, however, that even though numerous characteristics and advantages of the present invention have been set forth in the foregoing description, together with details of the structure and function of the present invention. Sequence or order of the specific steps or actual composition materials used may vary somewhat, furthermore, it will be appreciated that this disclosure is illustrative only and that changes may be made in detail, especially matters of shape, size, arrangement of parts or the sequence or elements of aspects of the invention will fall within the principles of the invention to the fullest extent indicated by the broad general meaning of the terms of which the appended claims, which form a further part hereof, are expressed.