Knee restraint system

Abstract

An improved method and apparatus for restraining a patient's leg during knee surgery or similar procedure features and improved restraining member that is attachable to an operating room table. The restraining member has a lower concave portion that engages the upper portion and sides of the patient's leg. The restraining member has an upper convex portion that is reinforced with a plurality of ridges. The concave portion can be fitted with an inflatable bladder. The concave portion in other embodiments is fitted with a belt arrangement that enables different degrees of constriction to be imparted to the leg. In one embodiment, a base or cradle supports the leg from below. A top arc member is removably attachable to the base or cradle (pivotal connection or sliding connection). The top arc member is movable between open and closed positions.

Claims

1. A leg restraining apparatus for use in knee surgery and in combination with a surgical table upon which a patient is resting, comprising: a) a restraining member removably attached to the table, the restraining member having a base member having a first end and a second end, wherein the second end has a pair of spaced apart, vertically extending flanges with a recess portion in between said flanges, each said flange having an upper end and said base member having a curved concave section that is positioned to cradle part of the patient's leg; b) the restraining member including a curved arc member having a constant diameter and having open and closed positions, wherein the arc member includes a first end portion that is a free end, wherein the free end abuts a surface of the base member first end in the closed position, wherein the free end is removably connected to the base member via a latch; c) the curved arc member including a second end portion that is a thickened section, wherein said second end portion is positioned in the recess portion in between said flanges and attached to the base member with a pivotal connection on said base that is below said flange upper ends, wherein the arc member is movable between said open and closed positions via said pivotal connection; d) wherein said arc member first end portion is disconnected from the base member in the open position, and wherein the restraining member prevents substantial movement of the patient's leg when the curved arc member is in the closed position; e) the restraining member having a connector that enables connection to the table; f) the open position of the curved arc member enabling a surgeon to flex the patient's leg and knee, including elevating the patient's leg above the base; and g) wherein at least part of said thickened portion occupies said recess between said flanges in both said open and closed positions and the flanges extend above the thickened portion in the open position.

2. The leg restraining apparatus constructed in accordance with claim 1 further comprising an inflatable cuff attached to said restraining member.

3. The leg restraining apparatus constructed in accordance with claim 1 wherein the base is a cradle having an upwardly facing concavity that cradles the patient's leg from below.

4. The leg restraining apparatus constructed in accordance with claim 1 wherein the restraining member is of a polycarbonate material.

5. The leg restraining apparatus constructed in accordance with claim 4 wherein the restraining member is of a glass polycarbonate blend.

6. The leg restraining apparatus constructed in accordance with claim 4 wherein the restraining member is of in excess of 50% long strand glass and polycarbonate plastic material.

7. The leg restraining apparatus of claim 1 wherein the restraining member base member does not encircle the patient's leg.

8. The leg restraining apparatus of claim 1 wherein the pivotal connection includes a pin removably inserted through one of said base member flanges, into the second end portion of the curved arc member, and through the other of said base member flanges.

9. The leg restraining apparatus of claim 1, further comprising a latch on the first end of the base member for securing the free end of the curved arc member in the closed position.

10. The leg restraining apparatus of claim 1, wherein the curved arc member does not encircle the patient's leg.

11. A leg restraining apparatus for use in knee surgery and in combination with a surgical table upon which a patient is resting, comprising: a) a restraining member removably attached to the table, the restraining member having a connecting portion that includes a flange and that attaches to the table, a cradle section having first and second end portions, and a concave portion that is positioned to cradle part of the patient's leg, wherein the second end portion includes a pair of spaced apart, vertically extending flanges having a recess in between said flanges, each said flange having a flange upper end; b) the restraining member including a curved top arc having a constant diameter and having open and closed positions, wherein the arc includes a first end that is a free end that is detachable from said cradle section via interlocking surfaces of the free end and the cradle section, wherein the free end is secured to the cradle section with a locking mechanism; c) the arc including a second end that is a thickened section and that is positioned in between said pair of spaced apart flanges and in the recess; d) wherein the curved top arc second end is pivotally attached to the cradle at a pivotal connection that is below said flange upper ends; e) wherein said arc rotates between said open and closed positions, wherein said arc first end is disconnected from the cradle section in the open position; f) wherein the restraining member prevents substantial movement of the patient's leg when the curved arc member is in the closed position; g) the open position of the curved top arc enabling a surgeon to flex the patient's leg and knee, including elevating the patient's leg above the cradle section; and h) wherein at least part of said thickened portion occupies said recess between said flanges in both said open and closed positions and the flanges extend above the thickened portion in the open position.

12. The leg restraining apparatus of claim 11, further comprising an inflatable cuff attached to said restraining member.

13. The leg restraining apparatus of claim 11, wherein the cradle section has an upwardly facing concavity that cradles the patient's leg from below.

14. The leg restraining apparatus of claim 11, wherein the restraining member is of a polycarbonate material.

15. The leg restraining apparatus of claim 14, wherein the restraining member is of a glass polycarbonate blend.

16. The leg restraining apparatus of claim 14, wherein the restraining member is of in excess of 50% long strand glass and polycarbonate plastic material.

17. The leg restraining apparatus of claim 11, wherein the cradle section does not encircle the patient's leg.

18. The leg restraining apparatus of claim 11, wherein the curved top arc is connected to the cradle section via a removable pin that is inserted through one of said flanges, into the second end portion of the curved top arc, and through the other of said flanges.

19. The leg restraining apparatus of claim 11, further comprising a latch on the cradle section first end for securing the curved top arc in the closed position.

20. The leg restraining apparatus of claim 11, wherein the curved top arc does not encircle the patient's leg.

Description

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

(1) For a further understanding of the nature, objects, and advantages of the present invention, reference should be had to the following detailed description, read in conjunction with the following drawings, wherein like reference numerals denote like elements and wherein:

(2) FIG. 1 is a fragmentary perspective view of an embodiment of the apparatus of the present invention;

(3) FIG. 2 is a sectional view taken along lines 2-2 of FIG. 1;

(4) FIG. 3 is a sectional view taken along lines 3-3 of FIG. 1;

(5) FIG. 4 is a top view taken along lines 4-4 of FIG. 1;

(6) FIG. 5 is a partial perspective view of an embodiment of the apparatus of the present invention;

(7) FIG. 6 is a partial perspective view of an embodiment of the apparatus of the present invention;

(8) FIG. 7 is a partial perspective view of an embodiment of the apparatus of the present invention;

(9) FIG. 8 is a perspective view of an embodiment of the apparatus of the present invention;

(10) FIG. 9 is a fragmentary perspective exploded view of an embodiment of the apparatus of the present invention;

(11) FIG. 10 is a close-up perspective view of an embodiment of the apparatus of the present invention;

(12) FIG. 11 is a fragmentary perspective view of an embodiment of the apparatus of the present invention illustrating a different construction for the restraining member;

(13) FIG. 12 is a fragmentary perspective view of an embodiment of the apparatus of the present invention illustrating a different construction for the restraining member;

(14) FIG. 13 is a fragmentary perspective view of an embodiment of the apparatus of the present invention illustrating a different construction for the restraining member;

(15) FIG. 14 is a perspective view of an alternate embodiment of the apparatus of the present invention;

(16) FIG. 15 is a perspective view of an alternate embodiment of the apparatus of the present invention;

(17) FIG. 16 is a sectional elevation view of a second embodiment of the apparatus of the present invention;

(18) FIG. 17 is a fragmentary sectional view of a second embodiment of the apparatus of the present invention;

(19) FIG. 18 is an exploded perspective view of a second embodiment of the apparatus of the present invention;

(20) FIG. 19 is a perspective view of a third embodiment of the apparatus of the present invention;

(21) FIG. 20 is a perspective view of a third embodiment of the apparatus of the present invention;

(22) FIG. 21 is a sectional view taken along lines 21-21 of FIG. 19;

(23) FIG. 22 is a side view of an air bladder attached to a leg restraint;

(24) FIG. 23 is an elevation side view of an alternate embodiment of the apparatus of the present invention showing the patient's leg in an extended, horizontal position with restraint closed;

(25) FIG. 24 is an elevation side view of an alternate embodiment of the apparatus of the present invention showing the patient's leg in a flexed 90 degree position wherein the restraint has been opened;

(26) FIG. 25 is a schematic diagram of an alternate embodiment of FIGS. 23-24 showing patient prone on table, patient with top arc opened and patient with leg flexed about 90 degrees;

(27) FIGS. 26-27 are perspective views of an alternate embodiment of FIGS. 23-25;

(28) FIG. 28 is a perspective view of an alternate embodiment of the apparatus of the present invention showing the bottom section of the device;

(29) FIG. 29 is an elevation view of an alternate embodiment of the present invention wherein top arc is in the form of a sliding member or bar that slides to separate from the restraint base;

(30) FIG. 30 is an elevation view of an alternate embodiment of the present invention wherein the top arc is in the form of a sliding member or bar that slides to separate from the restraint base;

(31) FIG. 31 is a schematic view of an air bladder that is preferably connectable to the restraint apparatus of FIGS. 23-30;

(32) FIG. 32 is a perspective view showing another embodiment of the apparatus of the present invention;

(33) FIG. 33 is a view of an air bladder in an inflated configuration; and

(34) FIG. 34 is a view of an air bladder attached to another embodiment of the apparatus of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

(35) FIGS. 1-10 show an embodiment of the apparatus of the present invention designated generally by the numeral 10 in FIG. 8.

(36) Leg restraint apparatus 10 is shown in use in FIG. 8 with a standard operating room table 11 having an upper surface 12 that is receptive of a patient 13. During certain types of orthopedic examination procedures or surgeries, it is necessary to restrain or immobilize a patient's leg 14. A locking mechanism 15 is used in combination with table 11 to hold the leg 14 of a patient 13. The locking mechanism 15 includes a body 16 that is mounted to the table 11. The body 16 provides a vertical slot 17 intersected laterally with an internally threaded opening 18 that is receptive of threaded set screw 19. In this fashion, restraining member 20 or 20A or 20B can be inserted into slot 17 and then clamped and rigidly held to body 16 when set screw 19 is tightened relative to body 16. Operating room tables 11 typically have instrumentation holders for varied apparatus that slide along table rails for positioning, then clamped down in accordance with the patient's height/size.

(37) The restraining member 20, 20A, 20B can include a vertical or mounting flange 22 to which is integrally attached a thickened section 23 and a curved section 21. The restraining member 20, 20A, 20B is of a disposable plastic material, such as of injection molded plastic.

(38) Curved section 21 provides an upper surface 24 that is reinforced with a plurality of longitudinal webs 25 and a plurality of diagonally positioned webs 26. Lower surface 27 of curved section 21 is preferably smooth, as shown in FIGS. 1 and 2. As seen in FIG. 2, flange 22 has inner surface 22a and outer surface 22b. Thickened section 23 has surfaces 23a, 23b, 23c. Surfaces 22a, 23b form a first obtuse angle. Surfaces 22b, 23c form a second obtuse angle that is larger than the first obtuse angle.

(39) The first obtuse angle created by surfaces 22a and 23b can be preferably 121-125, and most preferably 123. The second obtuse angle created by surfaces 22b and 23c can be preferably 141-145, and most preferably 143. This is preferably the angle range at which the thickened section 23 can be molded and therefore maintain the required rigidity and strength of the brace arc. A different angle could be used based on the different size of the overall arc/brace required, for example, to accommodate smaller or larger leg mass based on the size of a person. Adjusting the angle to a greater or a smaller angle would result in a reduced or increased arc facilitating the overall size of the brace and its use with different leg sizes. This variation of angle ranges would allow for extreme sizes and possibly rigidity and strength issues when made with hybrid materials. The angles as specified herein fit approximately 95% of the population due to the design and use of the air bladder/tourniquet technique. The design is further unique in that this angle arc interface allows for a singular device to address such a large population of patients requiring no further adjustment in order to perform the surgical procedures of meniscectomy and/or ACL repair. Furthermore, it allows for the implementation of a technique that does not require a tourniquet by applying partial restrictive pressure to blood vessels via the air bladder, combined with cold saline, to perform meniscus repairs (the air bladder does not circumvent the patient limb/leg). The aspect that the air bladder does not circumvent the limb is also unique, as other devices with air bladders and/or foam padding circumvent the limb.

(40) Opening 28 extends between the upper surface 24 and lower surface 27. The leg restraining member 20 provides sides 29, 30 that are preferably flat and generally parallel.

(41) In FIGS. 3-10, restraining member 20 is provided with an inflatable bladder 31. The bladder 31 can be supplied with air through a valve 32. As indicated by arrow 33 in FIG. 5, valve 32 can extend through opening 28. Inflatable bladder 31 can be attached to restraining member 20 using adhesive 34 as indicated by arrow 35 in FIG. 5.

(42) Inflatable bladder 31 can be attached to restraining member 20 using a hook and loop or Velcro.sub.C type connection, the hook fasteners 36 being attached for example to inflatable bladder 31 while the loop fasteners 37 are provided on the curved surface 27 of restraining member 20. Arrow 38 in FIG. 7 illustrates an attachment of bladder 31 to restraining member 20 using a hook fastener 36 and loop fastener 37 connection.

(43) In FIGS. 11-13, other arrangements of a restraining member are shown. In FIG. 11, restraining member 20A provides an ell shaped flanged member 40 that is separate from curved section 21, the parts 21, 40 being joined with a connection 39 that is formed by a plurality of openings 41 in flanged member 40 that align with openings 43 through flanges 45, 46 of curved section 21. The parts 21 and 40 being secured with one or more bolted connections that can include a plurality of bolts 42 and nuts 44 as shown in FIG. 11. Slot 47 provides a space in between the flanges 45, 46 that is receptive of flange member 40.

(44) In FIGS. 12 and 13, the restraining member 20B is first threaded through a leg cradle 48 having a projection 49 that cooperates with and connects to a socket 50 provided on the restraining member 20B. In FIG. 13, the connection has been complete, the vertical flange 22 of restraining member 20B extending through opening 73 of cradle 48 and then being connectable to the body 16 as with the embodiment of FIGS. 1-10.

(45) FIGS. 14-18 show another embodiment of the apparatus of the present invention, designated generally by the numeral 51.

(46) Leg restraining apparatus 51 provides a vertical flange 52 that is connectable to the vertical slot 17 of body 16 using threaded set screw 19 and internally threaded opening 18 as with the embodiment of FIGS. 1-13. In FIG. 14, a cradle 53 has a flat underside that can be rested upon upper surface 12 of operating room table 11. Cradle 53 provides a concavity 55 defined by curved surface 56 of cradle 53. Cradle 53 provides a curved slot 57 that is receptive of belt 58. The belt 58 can include multiple belt sections 69, 70.

(47) A belt free end portion 59 forms a connection with another belt free end portion 60. Outer surface 61 of each belt section 69, 70 can be provided with transverse grooves 62 for increasing belt 58 flexibility. Each belt section 69, 70 has an inner surface 63 that is generally smooth and curved as shown. However, the inner surface 63 of each belt 58 or belt section 69, 70 can also be provided with transverse grooves 64 as shown.

(48) The belt free end portion 60 provides a handle 65 that enables a user to tighten the free end portion 60 relative to the free end portion 59. In that regard, the free end portion 59 provides upwardly facing teeth 66, while the free end portion 60 provides downwardly facing teeth 67 as shown in FIGS. 14-18. If the belt 58 is formed of multiple belt sections 69, 70, the curved slot 57 can provide teeth at 74 that form a connection with the teeth 71, 72 of the belt sections 69, 70.

(49) In FIGS. 15-16, the patient's leg 14 is shown secured within the belt sections 69, 70. A donut shaped pad 68 can be placed as an interface between the belt sections 69, 70 and cradle 53 and the patient's leg 14.

(50) FIGS. 19-21 show another embodiment of the apparatus of the present invention. In FIGS. 19-20, leg restraining apparatus 75 provides a vertical flange 76 that is integrally attached to cradle 77. Cradle 77 provides a flat surface or underside 78 that can rest upon the operating room table 11 upper surface 12. Cradle 77 provides a concavity 79 defined by curved surface 80. The curved surface 80 can extend a full 180 degrees as shown in FIG. 20 or can be less than 180 degrees as shown in FIG. 19. An ell shaped channel 81 extends through cradle 77 as shown in FIG. 19. Channel 81 extends to pinion gear 82 and then exits via outlet 96. The free end portion of belt 84 can be gripped at d-ring 89 by a user as shown in FIG. 19, illustrated schematically by the arrow 97. Belt 84 is a toothed belt, having a toothed surface 87 that engages teeth 83 of pinion gear 82. Belt anchor pin 85 anchors belt 84 to cradle 77 as shown in FIGS. 19 and 20. Belt anchor pin 85 is secured to pin opening 86, also extending through an opening at an end portion of the belt 84.

(51) Pinion gear 82 has a gear shaft 90 that is mounted to opposing sides of cradle 77 as shown in FIG. 21. Locking pin 91 can be used to form an interlocking connection with an opening 95 in gear plate 94 that is attached to and rotates with pinion gear 82. Locking pin 91 can provide a knob 92 and spring 93. The spring 93 normally holds the locking pin 91 in a locking position as is shown in FIG. 21. Knob 92 enables a user to pull the pin away from pinion gear 82 for unlocking the pinion gear and enabling a user to tighten the belt 84. When a user releases the knob 92, spring action provided by spring 93 thrusts the locking pin 91 back into engagement with one of the openings 95 in plate 94 of gear 82.

(52) The embodiment of FIGS. 19-21 can also be used with a donut shaped pad 68, as is shown in FIGS. 15-16.

(53) FIGS. 22 and 33 show another embodiment of the present invention including an air bladder 100 that can be attached to the arc 101 of an arthroscopic knee restraint 110 by threading the support arc 101 through the air bladder sleeve 102 and actual air membrane. Air bladder 100 can be made of a plastic material with an air intake hose 104 attached for the purpose of inflation and deflation of air bladder 100 as needed for surgical support during arthroscopic knee surgery with a leg restraint 110.

(54) Air bladder 100 can be encased in an outer envelope or sleeve 102 with a slot opening 105 proximal to the air intake attachment 104 and another slot opening 106 distally close to the distal end of the air bladder housing 102. The outer envelope 102 can be of a different material from air bladder 100. The two slots 105, 106 allow for the threading of the arc 101 of leg restraint 110 to be placed into the proximal slot 105 first and threaded through to the distal slot 106, thus providing an encasing mechanism directly to leg restraint 110, and the air attachment tube 104 can be threaded through a hole provided in the leg restraint to further anchor the air bladder 100 to the leg restraint 110 (see for example FIGS. 22, 33).

(55) The inside portion or member 107 of the air bladder 100 can cover the entire inside surface of arc 101 of the arthroscopic knee restraint 110, from its proximal point all the way to the distal end (see for example FIG. 22). This portion 107 preferably inflates, as indicated by the arrows in FIG. 33, to facilitate sizing of all patient legs to the arthroscopic knee restraint 110. The inflated portion 107 allows the brace to be used for different leg sizes. FIG. 33 shows inner portion or member 107 in an inflated configuration. The shaded area shows the envelope or member 107 inflated to preferably size a patient's leg to the brace. The use of the inflated portion 107 preferably immobilizes the leg 14 in between the inflated member 107 and the top of the operating table 11, so that surgery can be performed arthroscopically.

(56) Bladder 100 can be held in the correct position by an air attachment tube 104 at the proximal end. The outside portion of the air bladder sleeve 102 preferably does not cover the arc 101 of the leg restraint structure fully, extending distal of the air attachment tube 104 location all the way distally to the end of the arc of the structure of the arthroscopic knee restraint 110. Air bladder sleeve 102 can include straps or sleeves to hold the inside portion 107 to the inner surface of leg restraint arc 101.

(57) This novel method of attachment preferably allows for rapid set-up of the operative leg restraint to perform knee arthroscopy; preferably permits easy replacement of air bladders for multiple surgery procedures; and preferably allows for rapid flash sterilization of the leg restraint between surgical procedures. The scope and purpose of the novel air bladder attachment method is to facilitate the surgical procedure, increase efficiency and efficacy, and reduce the overall cost of performing knee arthroscopy.

(58) The primary benefit to this novel air bladder attachment method is preferably to provide improved set-up time for operative procedures, eliminate complex attachment methods such as Velcro, and readily enable quick surgical sterilization and facilitate sterility flash process of the air bladder 100 and arthroscopic knee restraint 110.

(59) In various embodiments, the air bladder 100 of the present invention can be preferably used with any leg restraint embodiment disclosed herein. Alternatively, the air bladder can be preferably used with any restraint that has an arc and a hole for the air bladder inflation and deflation; and can preferably fit other leg restraints that might be developed in the future similar to the restraint disclosed herein.

(60) The air bladder 100 can be preferably a single use device, and disposable, so as to maintain the highest level of cleanliness.

(61) In another embodiment, a knee restraint device can preferably allow a surgeon to raise a knee joint post ACL repair (as many do today) thus fully covering all aspects of the knee arthroscopy surgical process (see FIG. 24). This embodiment preferably incorporates a top arc that would slide off post implant of the ACL ligament, and preferably allow the surgeon to raise the knee joint past 90 degrees, testing the implant integrity. The apparatus can be preferably useful for the surgeons that use this approach, as compared to the procedure of sitting and merely letting the lower leg flex downward to 90 degrees as previously used. The top arc break/opening feature can allow a surgeon to test the knee flexibility post ACL repair by preferably opening the top arc and flexing the knee joint about 90 degrees, while the patient is laying prone on an operating room (OR) table (see FIGS. 23-25).

(62) The operational principle of this improved design embodiment and other embodiments is basically the same. One difference is that the improved design preferably allows for the leg to be bent at the knee about 90 degrees by opening of a top arc which can be preferably hinged and has a release push-pull button/cap on the one end, or removably connected, when operating on a horizontal plane. During regular operating room (OR) surgery, the top arc can be locked in place and holding the full circle closed. An air bladder 100 can be preferably used to provide a sizing mechanism for different leg sizes. Upon completion of surgery, especially to test a ACL repair that is being performed on a horizontal plane (the OR table is preferably flat) by a surgeon that prefers to operate standing up, the top arc can be released to allow the surgeon to flex the patients repaired knee ACL to 90 degrees, testing the new implanted and attached ACL (see FIGS. 23-25).

(63) This same method would preferably be used when performing a meniscectomy in a horizontal position with a standing operative surgery method.

(64) Some of the other models/embodiments show diverse methods for attaching the top arc, but essentially all perform the same tasks in the same fashion.

(65) The device internal (inside diameter of device) diameters would preferably be about a 8 to 9-inch size, although it could change for very large legs should it be necessary. The width of the structure is the same as the original leg restraint, about 1th inches, and the materials for manufacturing can preferably be polycarbonates with long strand glass fibers and/or polycarbonates with carbon fibers (new material that is much stronger).

(66) In one embodiment, a top arc can be preferably capable of sliding off during surgery for this crucial test, and then preferably replaced again should further intervention be required. The attachment can be preferably via ball point on the arc, for example, and a corresponding slot in the leg restraint support arms on both sides, as seen in FIGS. 29-30. The major pressure point can be preferably on either lateral support, for example, and less towards the top and/or upward pressure.

(67) The edges of the structure/support arms can be preferably rounded on both sides in order to increase patient safety and comfort while the surgeon manipulates the leg/knee joint during surgery. The device can preferably employ a similar air bladder 100 as previously used as well to better size patient's thighs.

(68) In an embodiment of the leg restraint, two sliding locks can be preferably used to hold the top arc in place during surgery. The top arc can be preferably opened up to allow the surgeon to operate on a horizontal OR table set-up, and flex the knee joint upwards following ACL repair to test the integrity of the new ACL ligament following attachment. This embodiment may also be used by those surgeons that prefer to operate standing up on a flat OR table rather than seated. The materials are similar, although today there are some new versions that incorporate carbon fibers that make the material substantially stronger and more rigid that the other polycarbonate material (EMS Grivory 7H).

(69) In an embodiment, the final approach to testing the knee is by flexing it upward from a flat OR Table versus one with the end at 90 degrees plus. The advantage is for those performing ACL repairs on a flat OR Table (horizontal) and having the ease of swinging the upper arc out of the way to perform the flex test after attaching a new ACL. This system versus the current ones is much easier, self-contained without having to remove any parts, and readily locks back in place should it be required to continue the surgical repair. Also, it is extremely light weight, easy to operate, and has all the properties of a SS device (strength and rigidity) without the cumbersome aspects of a heavy and robust device.

(70) Various embodiments can be preferably manufactured with carbon fiber polycarbonates, for example, resulting in weight loss and increased strength and rigidity, upping the benefits and features of this model. The material can preferably include polycarbonate with long glass fibers and polycarbonates with carbon fibers, which is new material much stronger than existing glass fiber material.

(71) FIGS. 23-32 show various embodiments of the apparatus of the present invention. In FIGS. 23-25 there can be seen an operating room table 11 with a patient 13 preferably lying on the upper surface 12 of the table 11. This arrangement of patient 13 and table 11 can be an arrangement suitable for certain leg surgery procedures such as anterior cruciate ligament or ACL repair. In FIG. 23, the patient 13 has a leg 14 that is secured with clamp apparatus 120, 140, or 160.

(72) The embodiments seen in FIGS. 23-32 can weigh between 1 and 2 pounds, more preferably between 1.5 and 2 pounds, and most preferably about 2 pounds. The embodiments seen in FIGS. 23-32 are preferably molded of polycarbonates with long strand glass fibers, and/or carbon fibers for maximum strength, rigidity, and structural integrity.

(73) In FIG. 23, the patient 13 is in a prone position on the operating room table 11 upper surface 12 with legs 14 outstretched. The patient's leg 14 is preferably secured in restraint 120, 140 or 160. In FIG. 24, the clamp apparatus 120, 140, 160 has been opened or moved to an open position (see for example FIG. 26). The patient's leg 14 is flexed about 90 degrees. The open position of the apparatus preferably allows a surgeon to flex the patient's leg 14 about 90 degrees to check the ACL repair.

(74) FIG. 25 is a schematic diagram, similar to embodiments of FIGS. 23-24, showing patient 13 prone on table 11, patient 13 with top arc opened and patient 13 with leg 14 flexed about 90 degrees.

(75) FIGS. 26-28 show leg restraint apparatus 120 in more detail. The restraint apparatus 120 preferably has a cradle or base 121 with flat underside 122 that preferably engages upper surface 12 of table 11 during use. Cradle or base 121 preferably has a concave portion or concavity 123 that preferably cradles the patient's leg 14. Top arc 124 can be preferably pivotally connected to cradle or base 121 at pivot or pivotal connection 125. Pivot or pivotal connection 125 can preferably utilize a pin or removable pin 126 having head 127. Pin 126 can be preferably removed from base 121 to preferably allow complete removal of arc 124, as seen in FIG. 28.

(76) Top arc 124 can be preferably pivotally attached to the cradle or base 121. The patient's leg 12 can be confined with the base/cradle 121 and top arc 124, wherein the top arc 124 preferably covers the top and part of the sides of the patient's leg 14, but does not engage the underside of the patient's leg 14. The cradle or base 121 can preferably be placed under but does not encircle the patient's leg 14. The top arc 124 can be opened or closed to selectively restrain or enable release of the patient's leg such as when a surgeon wants to flex the leg after knee surgery on the patient.

(77) The dimensions (diameter) horizontally of the interior of restraint apparatus 120 are preferably made up by concavity 123 and top arc 124, and can be preferably about 8-9 inches and the vertical diameter dimension can be preferably about 8-9 inches, which preferably accommodates preferably about 95% of legs being operated on today. An air bladder can be preferably used and can act in a manner to secure the leg by sizing the leg to the brace so that it is held firmly in place.

(78) Base or cradle 121 preferably has a pair of spaced apart flanges 128, 129 preferably opposite pivot 125 with a recess 130 between the flanges. The distance between flange 128 to flange 129 can be about 2 inches. These flanges 128, 129 are preferably on opposing sides of top arc 124 and preferably provide rigidity to the apparatus 120 during use.

(79) Latch 132 preferably enables closure of top arc 124 in recess 131 when top arc 124 moves from the open position 133 to the closed position 134 (FIGS. 26, 27). Opening 135 preferably allows latch 132 to be attached to base or cradle 121 in order to secure arc 124 in place.

(80) An air bladder can be preferably used on apparatus 120 with including an opening 163 for placement on the opposite side of the inflation port.

(81) Another embodiment of the leg restraint apparatus is designated generally by the numeral 140 in FIGS. 29-30. Restraint apparatus 140 preferably has a base or cradle 141 with a flat underside 142 that preferably rests upon upper surface 12 of operating room table 11. Base or cradle 141 preferably has a concave position or concavity 143. Top arc/top sliding bar 144 preferably connects to base/cradle 141 with spaced apart connections 146, 147. Each connection 146, 147 can be a ball and socket/sliding connection enabling separation of the top arc/bar from base or cradle 141 by sliding the arc longitudinally such as toward the patient's head or toward the patient's feet. Base/cradle 141 can preferably have an air connector hole 145 for an air bladder attachment.

(82) Top arc 144 can preferably slide on and affix to base 141 preferably via a ball joint 164, 165 sliding into an oval cavity 166, 167 of similar dimensions with enough play to allow for smooth horizontal movement on and off. The top arc attachment can be preferably via ball point 164, 165 on the arc 144, and preferably a corresponding slot 166, 167 in the leg restraint support arms 168, 169 on both sides, as seen in FIGS. 29, 30. The major pressure point can preferably be on either lateral support 168, 169, and less towards the top and/or upward pressure. The edges of the structure/support arms 168, 169 can be preferably rounded on both sides in order to increase patient safety and comfort while the surgeon manipulates the leg/knee joint during surgery. Leg restraint 140 can preferably employ a similar air bladder as the other embodiments as well to better size a patient's thigh/leg.

(83) In FIG. 31, a dispersible air bladder 148 can be provided that can preferably be fastened to either base or cradle 121, 141 or to top arc 124, 144 or to both. Air bladder 148 preferably has inflation hose 149 that can be inserted through an air connector hole 145 in base/cradle 121 or 141 or to top arc 124, 144 or to both. Air bladder 148 can have sleeve parts 150 and open areas 151. The leg restraint apparatus embodiments can be used either with an air bladder sleeve, or a foam sleeve surrounding the leg.

(84) FIGS. 32 and 34 show another embodiment of the present invention showing a latch arrangement apparatus 160 wherein top arc 184 and cradle or base 181 have interlocking portions 161, 162. Top arc 184 seen in FIGS. 32, 34 can be preferably pivotally connected to cradle or base 181 at pivot or pivotal connection 185. Interlocking portions 161, 162 connect together and preferably secure the arc 184 to base 181.

(85) Top arc 184 can be preferably pivotally attached to the cradle or base 181 at attachment connection 185. A patient's leg 14 can be confined with the base/cradle 181 and top arc 184, wherein the top arc 184 preferably covers the top and part of the sides of the patient's leg 14, but does not engage the underside of the patient's leg 14. The cradle or base 181 can preferably be placed under but does not encircle the patient's leg 14. The top arc 184 can be opened or closed to selectively restrain or enable release of the patient's leg 14 such as when a surgeon wants to flex the leg after knee surgery on the patient.

(86) Air bladder 100 can be attached to apparatus 160 as seen in FIG. 34. Sleeves or straps 102 can be used to hold inner member 107 to the inside portion of arc 184 or both arc 184 and base 181. The inner portion or member 107 allows the brace 160 to be used for different leg sizes. FIG. 34 shows inner portion or member 107 in an inflated configuration in dotted lines. The use of the inflated portion 107 preferably immobilizes the leg 14 in between the inflated member 107 and base portion 181, so that surgery can be performed arthroscopically.

(87) FIG. 27 shows structural struts of the leg restraint apparatus and the structural design of the leg restraint, which enhances strength and rigidity to the entire apparatus when used during surgery. The vertical portion/flange 52 can be about 1 3/16 inches wide and about 5/16 inches thick. The distance between flange 128 to flange 129 or base 121 can be about 2 inches.

(88) The embodiments of the leg restraint of the present invention are an innovative advantage in supporting the surgeon and patient during arthroscopic knee procedures. The system preferably includes: leg restraint device, air bladder, and operating room rail clamp, with no moving parts, extremely light weight, and easy to use.

(89) The embodiments of the leg restraint are designed as a unique mechanical surgical assistance device to preferably support the distal thigh and preferably allow full manipulation and stressing of the knee joint during arthroscopy and arthroscopic surgery. The apparatus can be made of a unique polycarbonate material, and a separate disposable air bladder preferably connects to standard tourniquet inflation devices (150 mmHg).

(90) The apparatus can be readily draped out of the sterile field due to its trim and conforming design, and preferably does not restrict surgical approach to the knee joint.

(91) A patient should preferably be positioned so that the patella is placed just distal to the knee break on the operating room table. A folded blanket can preferably be placed under the knee joint for added padding, if so needed. Routine preparation procedures are performed.

(92) Following prep, the tourniquet is preferably placed over the thigh proximal to the knee break; after which the leg restraint apparatus preferably with an attached air bladder, is placed over the tourniquet (the arc of the brace preferably encircles the tourniquet and the stem of the leg restraint is threaded thru the operating room table rail clamp provided with the device). The leg restraint apparatus is preferably pushed downward tightly, and the rail clamp is preferably engaged accordingly. Both the tourniquet and air bladder are preferably connected to air supply monitors/consoles. The air bladder can be inflated to not exceed 150 mmHg. The air bladder preferably acts as a sizing mechanism for patients with small leg diameters. The patient's leg is then preferably sterile draped.

(93) The knee portion of the operating room table is preferably flexed beyond 90 degrees; allowing the surgeon to come forward and sit at the end of the extremity. By placing the distal foot on either side of the surgeon, the surgeon preferably has complete control over the amount of vargus or valgus stress applied to the knee joint.

(94) Clinical experience to date has indicated marked ease of use as compared to other leg restraints and/or FIG. 4 techniques, reduced operative time, and resulted in increased comfort to both the patient and surgeon. The apparatus of the present invention is a safe, simple, and successful arthroscopy technique.

(95) The following is a list of parts and materials suitable for use in the present invention.

(96) TABLE-US-00001 PARTS LIST Part Number Description 10 leg restraint apparatus 11 operating room table 12 upper surface 13 patient 14 leg 15 locking mechanism 16 body 17 vertical slot 18 internally threaded opening 19 threaded set screw 20 restraining member 20A restraining member 20B restraining member 21 curved section 22 vertical flange/mounting flange 22a inner surface 22b outer surface 23 thickened section 23a surface 23b surface 23c surface 24 upper surface 25 longitudinal web 26 diagonal web 27 lower surface 28 opening 29 side 30 side 31 inflatable bladder 32 valve 33 arrow 34 adhesive 35 arrow 36 hook fastener 37 loop fastener 38 arrow 39 connection 40 flanged member 41 opening 42 bolt 43 opening 44 nut 45 flange 46 flange 47 slot 48 leg cradle 49 projection 50 socket 51 leg restraining apparatus 52 vertical flange 53 cradle 54 flat underside 55 concavity 56 curved surface 57 curved slot 58 belt 59 free end portion 60 free end portion 61 outer surface 62 transverse groove 63 inner surface 64 transverse groove 65 handle 66 teeth 67 teeth 68 pad 69 belt section 70 belt section 71 teeth 72 teeth 73 opening 74 teeth 75 leg restraining apparatus 76 vertical flange 77 cradle 78 flat underside 79 concavity 80 curved surface 81 ell shaped channel 82 pinion gear 83 tooth 84 belt 85 belt anchor pin 86 pin opening 87 toothed surface 88 smooth surface 89 d-ring 90 gear shaft 91 locking pin 92 knob 93 spring 94 gear plate 95 opening 96 outlet 97 arrow 100 air bladder 101 support arc 102 sleeve/envelope/housing/strap 103 air membrane 104 intake hose 105 slot/opening 106 slot/opening 107 air bladder inner portion 110 leg restraint 120 leg restraint apparatus 121 cradle/base 122 flat underside 123 concavity/concave portion 124 top arc 125 pivot/pivotal connection 126 pin/removable pin 127 head 128 flange 129 flange 130 recess 131 recess 132 latch 133 open position 134 closed position 135 opening 140 leg restraint apparatus 141 cradle 142 flat underside 143 concavity/concave portion 144 top arc/top sliding bar 145 air connector hole 146 connection 147 connection 148 air bladder 149 inflation hose 150 sleeve 151 open area 160 latch 161 interlocking portion on base or cradle 181 162 interlocking portion on top arc 184 164 joint/ball joint 165 joint/ball joint 166 slot/cavity 167 slot/cavity 168 arm 169 arm 181 cradle/base 184 top arc 185 pivot/pivotal connection

(97) All measurements disclosed herein are at standard temperature and pressure, at sea level on Earth, unless indicated otherwise. All materials used or intended to be used in a human being are biocompatible, unless indicated otherwise.

(98) The foregoing embodiments are presented by way of example only; the scope of the present invention is to be limited only by the following claims.