This application relates to several inventions concerning operating tables and accessories designed to facilitate surgical procedures on a limb, especially, but not exclusively, orthopaedic procedures involving the distraction, dislocation or replacement of a joint.
Many of the inventions presented here were first conceived with reference to a particular surgical procedure. Whilst it has been realised that these inventions are of wider applicability than in the surgical procedure for which they were first conceived, it is nevertheless convenient to describe that procedure so that the reader can gain an understanding of the inventions in that context.
The procedure for which the inventions presented here were first conceived is a form of hip replacement surgery, known as “anterior approach” total hip replacement surgery. Whereas the majority of hip replacement surgeries are conducted through an incision in the side or the back of the hip, the anterior approach uses a small incision at the front of the hip. One advantage associated with this is that, postoperatively, the patient will not have to sit on the incision site, so convalescence is less painful. In addition, the anterior approach differs from the lateral or posterior approaches in that it does not require the major muscles of the hip, such as the gluteal muscles or the hip abductors, to be detached during the operation. Instead, the surgeon is able to work between the muscles from the front, thus sparing the soft tissues from trauma. The approach is known as a “tissue-sparing” procedure for this reason.
The incision site is determined using the anterior superior iliac spine as a reference. An incision is made close to the intermuscular space between the tensor fascia lata and the sartorius muscle. The fascia overlying the tensor fascia lata is then incised in line with the skin incision. The intermuscular space is enlarged by hand until the hip capsule can be felt. Using retractors on the hip abductors and the medial femoral neck, an anterior-superior capsulotomy is then performed to aid in visualization and femoral mobilization.
Next, an osteotomy of the femur is performed and, once the final neck cut has been made at the preoperatively planned osteotomy level, the femoral head can be twisted to rupture the ligamentum teres. This facilitates later dislocation of the joint. Distraction and external rotation of the leg can also be applied to create room for the removal of the femoral head.
With the femoral head removed, retractors are used to expose the acetabulum, which is then reamed and a new acetabular cup is implanted in the conventional way. The leg is then positioned in slight adduction and significant external rotation to expose the proximal femur. The femur is progressively lifted until the osteotomy plane can be reached through the skin incision. The femur can be lifted in a number of ways, such as manually with a bone hook.
A wedge of cancellous bone is removed from the cut end of the femur, creating an entry into the femoral canal. Broaching is then performed with progressive broach sizes, beginning with a smaller broach than the planned prosthesis. Once the final broach is in place, calcar planing can be performed, to remove bone protruding above the level of the impacted broach.
Next, a process of trial reduction is performed. The appropriate neck trial is placed in a hole on the upper face of the broach. An appropriate femoral head trial is selected and assembled for trial reduction. After components are selected, the hip is dislocated and the trial components are removed, along with the broach.
The appropriate femoral stem is chosen and placed into the prepared broach cavity. The femoral stem is impacted and another trial reduction can be performed with the final femoral stem and the femoral head trial. Next, the selected femoral head component is placed onto the taper of the femoral stem and secured using an impactor or, in the case of a ceramic head, by hand. The hip is reduced and a final check of leg length, and hip motion and stability should be made. The incision is then closed and the procedure is complete.
Evidence is now beginning to accumulate that the anterior approach enjoys a number of benefits as compared with the more conventional lateral or posterior approaches. Patients recover more quickly because their major muscles are not detached during the operation. Minimal muscle damage also means that there are fewer postoperative restrictions on joint mobility. The procedure helps patients to bend their hips more freely and to bear their full weight very soon after surgery. Scarring is reduced because of the use of a relatively small incision, and postoperative joint stability may be improved partly because the major muscles have not been disturbed.
In addition to these benefits, using the anterior approach, an incision is made closer to the hip joint and at a location where subcutaneous fat and other tissue layers are typically thinner than elsewhere. This means that more patients, particularly overweight patients, may be candidates for hip replacement surgery using this technique than with other techniques.
Operations of the complexity of total hip replacement, including the anterior approach, are seldom performed without the assistance of specifically designed or modified operating tables. The requirement to support, rotate, distract, adduct and otherwise manipulate the operative leg whilst continuing to support the weight of the patient means that such tables or accessories are seldom simple in design.
Such an operating table is briefly and incompletely described in US patent publication no. 2006/0064103 (“Matta”). The table is the “PRO fx” table manufactured by Orthopedic Systems, Inc., which also manufactures the “Hana” table for anterior approach total hip replacements. These tables each have leg supports that cantilever off an operating table at one end and are capable of being set down on the ground at their other end. Another specially designed operating table can be found in U.S. Pat. No. 6,286,164 (“Lamb”). Specially designed operating tables such as these tend to be extremely expensive, and for this reason some attention has been paid in the recent past to the design of accessories for pre-existing operating tables, which can be bolted up to the table when required and removed when they are no longer needed.
Possibly the simplest design of operating table accessory designed to facilitate surgery on a limb is described and illustrated in US patent publication no. 2010/0263129 (“Aboujaoude”). This is a device designed to be bolted up to the lateral accessory rail that is a universal feature of modern day operating tables, and to immobilise and position the leg. The device has a rail mount clamp that attaches to the operating table rail. A telescopic arm extends vertically upwards from the rail mount clamp. A lower leg cradle support base is affixed to the top of the arm and a lower leg cradle body pivots on the lower leg cradle support base, allowing for rotational adjustment and fixation along the direction of the operating table rail. This device allows a number of adjustments to be made to the position of patient's leg, but its design is not such as to make it useful in anterior approach total hip replacement surgery. The device of Aboujaoude always immobilises the leg in a position of hip flexion, above the surface of the operating table, whereas the anterior approach requires the hip to be neutral or extended.
A similar accessory is described in U.S. Pat. No. 7,316,040 (“Siccardi”). The accessory of Siccardi bolts directly to a fixed point on an operating table and includes a joint that is said to provide three degrees of freedom of movement, but only seems to provide two. A track extends from that joint, to which limb support components are attached, and there appears to be a support leg with a wheel at the bottom and a telescopic strut attached to the leg, although the purpose of these components is unclear.
A more sophisticated table-mounted accessory is described in international patent publication no. WO2007/080454 (“Smith & Nephew”), this accessory being designed to bolt up to and be supported by a lateral rail of an operating table and to provide distraction of the hip at both supine and lateral positions of the patient on the table. One of the problems with accessories such as this is that they are cumbersome and time-consuming to set up on the operating table. They are very heavy and often require several technicians to assemble them in position. They transfer all of their own weight and that of the patient's limb through the lateral rail of the operating table.
The operating table accessory described in international patent publication no. 2006/051077 (“Memminger”) is one attempt to deal with the problems identified above and consists of a floor standing section that can be wheeled up to and attached to a patient trolley to provide support and distraction to the patient's leg. Another such accessory, albeit more complex, is described in U.S. Pat. No. 4,527,555 (“Ruf”).
However, one thing that is always to be borne in mind when undertaking surgical procedures of the kind described, is that things do not always go according to plan. Virtually all modern operating tables have an emergency tilt position into which they can be put if the patient suffers a cardiac arrest or other life-threatening emergency. The emergency tilt position is one in which the table tilts so that the patient lies at an angle of 10° to 15° with his head lower than his feet, and the surgeon needs to be able to put him into this position at a moment's notice. Neither Memminger nor Ruf allows this.
One of the inventions that has been conceived allows the use of an operating table accessory that is easy for a single person to set up relative to the operating table, yet still permits the table to adopt its emergency tilt position.
To that end, there is provided an operating table accessory for use during surgery on a limb, comprising a component to be mounted on an operating table and including a patient support, a floor-standing component including an articulated limb support, and cooperating locating features on the two components, adapted to locate the components relative to each other such that with the patient support supporting at least some of the weight of the patient, the articulated limb support is properly positioned to support and manipulate the limb, the cooperating locating features being so configured as to allow the table to be tilted relative to the floor-standing component while continuing to locate the components relative to each other.
Because the floor-standing component is floor-standing, it is coupled to the table by the locating features, but is not cantilevered from it, or in other words it does not require the table to bear its weight. It is a self-supporting component. This means there will be no need for the technicians to lift it into place before it can be coupled to the operating table. This makes it particularly easy to set up, but the invention improves upon previously-proposed floor-standing accessories by the use of cooperating locating features that accommodate tilting of the table relative to the floor-standing component.
One way of implementing such cooperating locating features is for one component to comprises a first part having a notch as a locating feature and the other component to comprise a second part having a pair of outwardly facing guide channels on either side as a locating feature, each guide channel having an outwardly facing base surface, the notch and the guide channels being adapted to locate the two components relative to each other by receipt of the second part into the notch and by receipt of the margins of the first part adjacent to the sides of the notch into respective guide channels. In this case, the guide channels and the margins of the first part adjacent to the sides of the notch should be so shaped as to allow the two parts to tilt relative to one another, thus allowing the table to be tilted relative to the floor-standing component while continuing to locate the components relative to each other. The first part can be a part of the table-mounted component and the second part, a part of the floor-standing component.
Because the accessory of this invention was originally conceived for use in surgery that involves limb distraction, although it should be clear that it can be used in other procedures too, the floor-standing component may comprise a substantially vertical reaction post and a thrust element that can be mounted on the reaction post. The reaction post provides a reference against which the distraction forces can be applied and the thrust element provides the surface against which the reaction forces from another part of the patient's body will be exerted. As an alternative, the thrust element may comprise the substantially vertical reaction post, which can then be mounted on the floor-standing component. For example, in the case of the anterior approach to total hip replacement, the thrust element will receive the reaction forces from the perineum as the distraction forces are applied to the lower leg. In the case of a shoulder arthroscopy where it is convenient to distract the glenohumeral joint, the distraction forces may be applied at the wrist and the thrust element will receive the reaction forces from the armpit. In one implementation, the thrust element is a thrust spacer having a vertical bore for sliding receipt of the reaction post and a thrust surface horizontally spaced from the vertical bore. In the alternative mentioned above, the bore may be in the floor-standing component, for sliding receipt of the reaction post affixed to the thrust element.
The use of a reaction post in the floor-standing component enables the second of the inventions presented here, which is independent of the first. Virtually every piece of equipment in an operating theatre is movable, because the theatre needs to be reconfigured as required, but what this can mean is that the surgeon's instruments, even if placed in an instrument tray, will ultimately be placed on a movable piece of equipment, such as a trolley, and may be moved. As anyone who has even so much as misplaced a screwdriver in his workshop will know, this can be extremely frustrating, and that is a state of mind that it would be better for a surgeon to avoid. However, once the accessory previously discussed has been arranged and located relative to the operating table, the reaction post provides what may be the only stationary point in the whole operating theatre. This invention takes advantage of that.
Thus, to provide a secure and fixed location for the surgeon's instruments, there is provided an operating table accessory for use during surgery on a limb, comprising a component to be mounted on an operating table and including a patient support, a floor-standing component including a substantially vertical reaction post, and an articulated limb support, cooperating locating features on the two components, adapted to locate the components relative to each other such that with the patient support supporting at least some of the weight of the patient, the articulated limb support is properly positioned to support and manipulate the limb, an instrument tray, and means for reversibly attaching the instrument tray to the reaction post.
Where a reaction post and thrust element are present, the thrust element can be used to provide the locating feature of the floor-standing component. In particular, the accessory may be designed so that the patient support has a notch as a locating feature, the thrust element has a pair of outwardly facing guide channels on either side as a locating feature, each guide channel having an outwardly facing base surface, the notch and the guide channels being adapted to locate the two components relative to each other by receipt of the thrust element into the notch and by receipt of the margins of the patient support adjacent to the sides of the notch into respective guide channels. In this case, the guide channels and the margins of the patient support adjacent to the sides of the notch should be so shaped as to allow the patient support and the thrust element to tilt relative to one another, thus allowing the table to be tilted relative to the floor-standing component while continuing to locate the components relative to each other.
The use of a thrust element that slides up and down the reaction post allows the table to be raised and lowered relative to the floor-standing component while the locating features continue to locate the components relative to each other. It also means that a greater degree of tilt of the table, or a tilt about an axis that is a greater distance from the locating features can be accommodated.
For reasons of convenience as well as visualisation, the thrust element may be a thrust spacer having upper and lower sections and a vertical bore for sliding receipt of the reaction post, the upper section having a thrust surface horizontally spaced from the vertical bore and the lower section having the guide channels on either side.
Given that the patient support and the thrust element are both going to be in the vicinity of the joint of interest, especially in the case of total hip replacement or shoulder arthroscopy, the patient support and the thrust element may be radiolucent. This facilitates X-ray imaging of the operative joint and is especially useful in the case where the thrust surface of the thrust element is spaced from the vertical reaction post, which itself is likely to be made from metal or other radiopaque material.
This allows the introduction of the third of the inventions presented here, which is concerned with facilitating the X-ray imaging of an operative joint during surgery, and is independent of the ability to accommodate tilting of the operating table or ability to put an instrument tray in a fixed position. To that end, there is provided an operating table accessory for use during surgery on a limb, comprising a component to be mounted on an operating table and including a patient support, a floor-standing component including a substantially vertical reaction post, a thrust spacer having a thrust surface, the thrust spacer being adapted to be mounted on the reaction post so that the thrust surface is horizontally spaced from the reaction post, and an articulated limb support, and cooperating locating features on the patient support and the thrust spacer, adapted to locate the components relative to each other such that with the patient support supporting at least some of the weight of the patient, the articulated limb support is properly positioned to support and manipulate the limb, wherein the patient support and the thrust spacer are radiolucent.
For the purposes of improved operative visualisation, the accessory may further comprise an X-ray grid for attachment to the patient support, or the patient support may incorporate an X-ray grid.
In the case where the locating features include guide channels and margins adjacent to the sides of a notch, so shaped as to allow the two parts to tilt relative to one another, the said margins may be substantially flat and the guide channels, crowned. The guide channels may be crowned on both their upper and lower surfaces.
To assist with proper alignment of the component parts, the sides of the notch and the base surfaces of the guide channels can cooperate to constrain relative rotation between the first part or patient support and the second part or thrust element, as the case may be, about a vertical axis. One way of achieving this is for the sides of the notch and the base surfaces of the guide channels to be substantially straight, and the angle between the sides of the notch to be substantially equal to the angle between the base surfaces of the guide channels. The sides of the notch may be substantially parallel and the base surfaces of the guide channels may be substantially parallel too, although it may be better for there to be an included angle to assist in initial location of the components.
For additional security, the operating table accessory may further comprise means for reversibly retaining the two components in a position such that with the patient support supporting at least some of the weight of the patient, the articulated limb support is properly positioned to support and manipulate the limb.
To allow the patient's limb to be manipulated during surgery, the limb support may be adapted to swivel substantially horizontally relative to the floor-standing component, for example by being mounted on and adapted to swivel with respect to the reaction post. To secure the limb in position, means may be provided for reversibly locking the limb support to prevent it from swivelling.
Vertical articulation of the limb can be accommodated by a proximal articulation of the limb support. So that the surgeon or other personnel need not bear the whole weight of the limb, the limb support may be biased upwards, for example by means of a gas strut. To prevent the limb from being dropped accidentally while attached to the limb support, the proximal articulation may comprise a releasable ratchet mechanism that permits the limb support to be raised, but not lowered until the ratchet mechanism is released. The limb support may comprise a distal release actuator operable to release the ratchet mechanism.
A bilateral version of the operating table accessory can be provided by furnishing the floor-standing component with a second articulated limb support. The first and second articulated limb supports may be laterally displaced from one another by being mounted, for example, to either side of the reaction post.
So as to provide at least gross adjustments to the length of the limb that the limb support can accommodate, the floor-standing component may further comprise a carriage movable with respect to the limb support along a predetermined path and adapted to engage a receptacle that holds the limb, and an interlock device adapted to lock the carriage to the limb support in any one of a number of positions distributed along the predetermined path, thus to prevent movement of the carriage along the path.
The interlock device may include a movable component and a stationary component, one on the carriage and the other on the limb support, the movable component being movable between an active position in which it engages the stationary component and an inactive position in which it does not, and the stationary component including a plurality of recesses adapted to receive the movable component when in its active position.
It is typical in equipment of this sort for the parts to be manufactured to extremely high tolerances. Witness, for example, the abstract of Aboujaoude, “ . . . a device or fixture for positioning and manipulating a patient's lower extremity for surgical and diagnostic procedures where alignment is critical and minute adjustments may be required.” However, what is little suspected or little known, is that these critical and minute adjustments are rarely needed. In a total hip replacement, for example, so long as the postoperative leg is different in length from the preoperative leg by no more than about 10 mm (more in some cases), the patient simply will not notice the difference. Thus, lower precision parts can be used and the carriage can be mounted on the limb support with a degree of play such that a limited range of movement of the carriage relative to the limb support is possible without moving the carriage along the predetermined path. The interlock device should then be so constructed as to accommodate the said degree of play, and be capable of locking the carriage to the limb support throughout the said limited range of movement.
A fourth of the inventions presented here takes advantage of the fact that critical tolerances are rarely required in equipment such as that described in this application. Again, it is independent of the inventions previously presented. To that end, there is provided an operating table accessory for use during surgery on a limb, comprising a limb support, a carriage movable with respect to the limb support along a predetermined path and adapted to engage a receptacle that holds the limb, and an interlock device adapted to lock the carriage to the limb support in any one of a number of positions distributed along the predetermined path, thus to prevent movement of the carriage along the path, wherein the carriage is mounted on the limb support with a degree of play such that a limited range of movement of the carriage relative to the limb support is possible without moving the carriage along the predetermined path, and wherein the interlock device is so constructed as to accommodate the said degree of play, and is capable of locking the carriage to the limb support throughout the said limited range of movement.
A fifth of the inventions presented here is concerned with the retention of the limb receptacle on the limb support. Again, it is independent of the inventions previously presented. Conventional mechanisms are not very convenient to use and typically require the limb receptacle to be mounted before the limb is attached, or involve an attachment mechanism that is difficult to use once the limb has been attached. To this end, there is provided an operating table accessory for use during surgery on a limb, comprising a limb support, a receptacle adapted to hold the limb, and cooperating retention features on the limb member and the limb receptacle, one of the retention features comprising a channel with an open end for receipt of the other retention feature and a closed end including means for reversibly retaining the other retention feature, wherein the size of the channel increases from the closed end to the open end, so as to facilitate receipt of the other retention feature into the open end of the channel, whereupon the other retention feature can be conveyed and guided along channel to the closed end to be retained in position at the closed end by the reversible retaining means.
The retention feature with the channel may be provided on the limb receptacle since in that way the other retention feature can be guided into closer proximity with the limb receptacle. Thus, there is provided a limb receptacle adapted to hold a limb and comprising a retention channel with an open end for receipt of a retention feature of a limb support and a closed end including means for reversibly retaining the retention feature, wherein the size of the channel increases from the closed end to the open end, so as to facilitate receipt of the other retention feature into the open end of the channel, whereupon the other retention feature can be conveyed and guided along the channel to the closed end to be latched into position at the closed end by the reversible retaining means.
The retention feature on the limb support may be a retention feature on a carriage that is movable with respect to the limb support along a predetermined path, including a carriage mounted on the limb support with a degree of play as previously mentioned.
The limited range of movement of the carriage relative to the limb support allowed by the degree of play may include limited rocking of the carriage transversely to the predetermined path. As stated above, the interlock device may include a movable component and a stationary component, one on the carriage and the other on the limb support, the movable component being movable between an active position in which it engages the stationary component and an inactive position in which it does not, and the stationary component including a plurality of recesses adapted to receive the movable component when in its active position. In this case, the size of the recesses measured in the direction of the predetermined path should exceed the corresponding size of the movable component by an amount that is less than the amount by which the size of the recesses measured in the direction transverse to the predetermined path exceeds the corresponding size of the movable component.
The predetermined path may be defined by a track on the limb support, the carriage including a chassis that movably engages the track. The limited rocking of the carriage is most discernable in the case where the carriage is reconfigurable between a first configuration in which its centre of mass lies to one side of the contact between the follower and the track and a second configuration in which its centre of mass lies to the other side. This may be the case where the accessory is reconfigurable from a left-handed to a right-handed configuration to allow an operation to proceed on the left or the right hip, as the case may be. The carriage may be reconfigurable by virtue of its further including a superstructure adapted to engage the limb receptacle and mounted on the chassis for movement between first and second positions corresponding to the first and second configurations of the carriage respectively.
To allow finer adjustments to the limb length, or to provide for distraction of the limb, the carriage may include both a retention feature adapted to engage a corresponding retention feature on the limb receptacle and means for advancing and retracting the retention feature relative to the carriage in a direction substantially aligned with the predetermined path.
As is typical, the means for advancing and retracting the retention feature may include a lead screw actuator. The lead screw may be driven by a hand wheel, and the retention feature connected to the lead screw nut.
In addition, to provide internal or external rotation of the limb, the retention feature on the limb carriage may be rotatable relative to the limb support, thus allowing the limb receptacle to rotate relative to the carriage. Locking means may be provided for preventing the rotation of the retention feature.
Although, as previously explained, exact tolerances are rarely required in equipment such as this, it is nevertheless useful for a surgeon to have some idea of the relative positions of the operative limb and the rest of the patient's body, since this will help him to ensure that the postoperative limb is about as long as it was preoperatively. The sixth of the inventions presented here is directed to that end and provides an operating table accessory for use during surgery on a limb, comprising a limb support, a carriage movable with respect to the limb support along a predetermined path and adapted to engage a receptacle that holds the limb, a scale along or adjacent to the predetermined path on the limb support, and a display device on the carriage adapted to read the scale and display information indicative of the position of the carriage along the predetermined path. Again, the sixth invention is independent of the inventions previously presented.
The scale may comprise a series of equally spaced detectable markers and the display device comprises means for counting the number of markers past which it has moved and to display information indicative of that number. For example, the detectable markers may be optically or magnetically detectable, and the display device comprise an optical or magnetic detector. To allow the surgeon to “zero” the display preoperatively, the information indicative of the position of the carriage along the predetermined path can be reset at any position of the carriage, for example by resetting the count maintained by the counting means. To this end, the display device may include a reset button for resetting the information or count.
It is useful in anterior approach total hip replacement to provide some means for elevating the proximal end of the cut femur, to facilitate the broaching and installation of the femoral neck. Similar means for elevating the limb are equally useful in other procedures. Thus, the floor-standing component may further include a proximal limb pad, wherein the cooperating locating features on the two components are adapted to locate the components relative to each other such that the proximal limb pad lies below a proximal portion of the limb, and means for reversibly raising the limb pad relative to the limb receptacle to apply a lifting force to the proximal portion of the limb.
The seventh of the inventions presented here relates to the provision of a proximal limb pad. Again, it is independent of the inventions previously presented. To that end, there is provided an operating table accessory for use during surgery on a limb, comprising a component to be mounted on an operating table and including a patient support, a floor-standing component including an articulated limb support, a receptacle adapted to hold the limb, and cooperating retention features on the limb support and the limb receptacle, a proximal limb pad on one of the two components, cooperating locating features on the two components, adapted to locate the components relative to each other such that with the patient support supporting at least some of the weight of the patient and the limb receptacle holding the limb, the articulated limb support is properly positioned to support and manipulate the limb and the proximal limb pad lies below a proximal portion of the limb, and means for reversibly raising the limb pad relative to the limb receptacle to apply a lifting force to the proximal portion of the limb.
The means for reversibly raising the limb pad relative to the limb receptacle may comprise means for fixing the limb pad in a plurality of vertical positions relative to the limb support, which would require manual adjustment, or it may comprise a motor. Alternatively, the raising of the limb pad relative to the limb receptacle may be achieved by moving the receptacle rather than the pad, for example by means of a proximal articulation of the limb support that allows the limb support to be raised and lowered. Here, the proximal limb pad may be on the floor-standing component.
As an alternative, the limb pad may be mounted for rotation about an eccentric pivot and the means for reversibly raising the limb pad relative to the limb receptacle comprise means for reversible rotating the limb pad about its eccentric pivot. This may be achieved by means for fixing the limb pad in a plurality of angular positions about its eccentric pivot. Here, the proximal limb pad may be on the table-mounted component. The proximal limb pad may be mounted onto the table-mounted component in such a way that the position of the eccentric pivot relative to the table-mounted component is adjustable.
Whilst the inventions presented here have in many cases been discussed with reference to a first component that is adapted to be mounted on an operating table, it will be understood that that component may be an integral feature of the table itself. Thus, alternative statements of the first, second, third and seventh inventions are as follows.
In respect of the first invention, there is also provided operating room equipment for use during surgery on a limb, comprising an operating table, a floor-standing accessory including an articulated limb support, and cooperating locating features on the table and the accessory, adapted to locate them relative to each other such that with the operating table supporting the weight of the patient, the articulated limb support is properly positioned to support and manipulate the limb, the cooperating locating features being so configured as to allow the table to be tilted relative to the accessory while continuing to locate the table and the accessory relative to each other.
In respect of the second invention, there is also provided operating room equipment for use during surgery on a limb, comprising an operating table, a floor-standing accessory including a substantially vertical reaction post and an articulated limb support, cooperating locating features on the table and the floor-standing accessory, adapted to locate them relative to each other such that with the table supporting the weight of the patient, the articulated limb support is properly positioned to support and manipulate the limb, an instrument tray, and means for reversibly attaching the instrument tray to the reaction post.
In respect of the third invention, there is also provided operating room equipment for use during surgery on a limb, comprising an operating table including a locating extension, a floor-standing accessory including a substantially vertical reaction post, a thrust spacer having a thrust surface, the thrust spacer being adapted to be mounted on the reaction post so that the thrust surface is horizontally spaced from the reaction post, and an articulated limb support, and cooperating locating features on the locating extension and the thrust spacer, adapted to locate the table and the floor-standing accessory relative to each other such that with the table supporting the weight of the patient, the articulated limb support is properly positioned to support and manipulate the limb, wherein the locating extension and the thrust spacer are radiolucent.
In respect of the seventh invention, there is also provided operating room equipment for use during surgery on a limb, comprising an operating table, a floor-standing component including an articulated limb support, a receptacle adapted to hold the limb, cooperating retention features on the limb support and the limb receptacle, and a proximal limb pad, cooperating locating features on the table and the floor-standing accessory, adapted to locate them relative to each other such that with the table supporting the weight of the patient and the limb receptacle holding the limb, the articulated limb support is properly positioned to support and manipulate the limb and the proximal limb pad lies below a proximal portion of the limb, and means for reversibly raising the limb pad relative to the limb receptacle to apply a lifting force to the proximal portion of the limb.
This invention also encompasses an operating table accessory to be mounted on an operating table for use during surgery on a limb, comprising a patient support adapted to support at least some of the weight of the patient, and a proximal limb pad mounted on the accessory for rotation about an eccentric pivot, such that rotation of the limb pad about the eccentric pivot reversibly raises the limb pad to apply a lifting force to a proximal portion of a limb.
An accessory component including a patient support may be mounted on the table and the locating feature on the table may then be a locating feature of the table-mounted accessory component. For example, the accessory component may be mounted on the table so as to be extendable from it and the locating features, so configured as to allow them to be approximated and to locate the components relative to each other such that with the patient support supporting at least some of the weight of the patient, the articulated limb support is properly positioned to support and manipulate the limb, by extension of the accessory component from the table.
Returning to the first of the inventions presented here, an improved method of preparing an operating table for surgery can be implemented. The method includes positioning a floor-standing accessory including an articulated limb support adjacent to the operating table, and offering a locating feature on the table up to a cooperating locating feature on the floor-standing accessory, to locate them relative to each other such that with the table supporting the weight of the patient, the articulated limb support is properly positioned to support and manipulate the limb, the cooperating locating features being so configured as to allow the table to be tilted relative to the floor-standing component while continuing to locate the components relative to each other.
The method may further comprise mounting an accessory component including a patient support on the table, in which the locating feature on the table is a locating feature of the table-mounted accessory component. Mounting the accessory component on the table may involve offering the locating feature of the table-mounted accessory component up to the cooperating locating feature on the floor-standing accessory.
As an alternative to this, the table may have mounted on it an extendable accessory component including a patient support, and the locating feature on the table is then offered up to the cooperating locating feature on the floor-standing accessory by extending the extendable accessory component. As previously discussed, the extendable accessory component may have a notch as a locating feature and the floor-standing accessory may comprise a locating part having a pair of outwardly facing guide channels on either side as a locating feature, each guide channel having an outwardly facing base surface. The guide channels and the margins of the patient support adjacent to the sides of the notch are so shaped as to allow the patient support and the thrust element to tilt relative to one another, thus allowing the table to be tilted relative to the floor-standing component while continuing to locate the components relative to each other. Thus, the notch and the guide channels are offered up to one another by receiving the locating part into the notch and by receiving the margins of the extendable accessory component adjacent to the sides of the notch into respective guide channels. In one implementation, the floor-standing component comprises a substantially vertical reaction post, and a thrust element that can be mounted on the reaction post, and the thrust element is the locating part.
The inventions presented here will be described with reference to the accompanying drawings, in which:
a shows the mounting of a patient support plate on the side frame members;
b and 4c show details from
a and 5b show how the patient support plate is clamped in place;
a and 12b illustrate how the limb support is able to swivel about the reaction post;
As illustrated in
The table-mounted component includes an aluminium left side frame member 101 and an aluminium right side frame member 102, each of which is designed to be affixed to a lateral accessory rail of an operating table 300. The left and right side frame members 101, 102 extend beyond the end of the operating table and are spanned by a radiolucent patient support plate 103. As will be described later, the patient support plate 103 is locked in place on each side frame member 101, 102 by an aluminium channel-section clamp plate 104. The right side frame member 102 is longer than the left side frame member 101 and on the end of the right side frame member is an additional, passive leg support plate 105 upon which the non-operative leg is supported during the operation.
The floor-standing component 200 includes an aluminium T-shaped base 201 with three height-adjustable feet 202, one at the end of the uptight of the T and the other two at respective ends of the cross-member. An aluminium box-section upright 203 extends vertically from the base 201 and a steel (or carbon fibre with a steel insert) vertical reaction post 204 extends out of the top of the box section upright 203. An aluminium support beam 205 is mounted on the reaction post 204 in such a way as to be able to swivel horizontally about the post 204. Vertical motion of the support beam 205 is permitted by means of a proximal articulation 206, which provides a horizontal axis about which the support beam 205 can be pivoted. The support beam is itself supported by a gas strut 207, linking a midpoint of the support beam 205 to the base 201. On top of the distal end of the support beam 205 is an aluminium track 208, along which a chassis 209 is able to slide. The chassis carries a superstructure including a lead screw mechanism 210, to the free end of which is attached a boot 211 that is adapted to retain the patient's foot. A perineal thrust spacer 212 is received on the reaction post 204 and is able to slide vertically with respect to it. With the exception of the reaction post 204, which will be made of steel, many of the remaining major components of the operating table accessory can be made of aluminium as already mentioned, or of a lighter weight carbon fibre composite material to aid in transportation.
The attachment of the side frame members 101, 102 of the table-mounted component 100 to the operating table is illustrated in
Each of the frame members 101, 102 is a simple box section with multiple pairs of apertures 107 along an outermost face. A pair of bolts (not shown) has been inserted through the apertures 107, and through smaller holes in the innermost face of the side frame member to be screwed into corresponding threaded bores in the E-shaped frame hangers 106. Each of the multiple pairs of apertures 107 along the outermost face is lined up with a pair of smaller apertures in the innermost face, thus allowing the hangers 106 to be positioned in multiple positions. This is useful because not all operating table rails 310 are continuous as illustrated in the figure; the ability to move the hangers 106 means that discontinuities in the rail 310 can be accommodated.
Each of the E-shaped hangers 106 includes in upper threaded hole 112, and a corresponding lower threaded hole 113, the purpose of which is to permit the insertion of a fixing screw (not shown) that clamps down onto the lower surface of the rail 310, preventing the frame member from sliding relative to the rail. As shown, the hangers 106 are reversible and this facilitates the reconfiguration of the whole assembly when swapping from an operation of the right hip to an operation on the left hip.
As illustrated in
As shown in
The shape of the patient support plate is best shown in
The structure of the thrust spacer 212 is illustrated in
The patient support plate 103 and the thrust spacer 212 are adapted to locate one another in the way illustrated in
The difference between the thickness of the patient support plate (15 mm) and the minimum distance between the crowned surfaces 218, 219 of the guide channels 217 (18 mm), together with the existence of the crowning on those surfaces, means that the patient support plate 103 and the thrust spacer 212 can remain engaged and located even when the patient support plate 103 has been tilted by an angle of 152 to 202. Because the thrust spacer 212 can slide upwards on the reaction post 204, the operating table can be tilted into its emergency tilt position about a transverse axis that is some distance from the engagement between the patient support plate 103 and the thrust spacer 212. The slide of the thrust spacer 212 on the reaction post 204 also allows the height of the operating table to be adjusted whilst the patient support plate 103 and the thrust spacer 212 remain engaged and located.
Both the patient support 103 and the thrust spacer 212 are constructed from a radiolucent material, such as reinforced polymer composites (e.g. glass fibre or carbon fibre composites), epoxy, polyether-ether-ketone (PEEK), thermoplastics, polyketones or polycarbonates, or any other radiolucent material with suitable mechanical properties, thus enabling X-ray imaging of the hip joint during surgery.
To help the surgeon to ascertain whether the pelvis has moved during the operation and otherwise to aid visualisation, an X-ray grid may be provided for attachment to the patient support, or the patient support may incorporate such a grid. The grid may be a simple mesh of radiopaque material, such as a metallic mesh, which can be fastened or screwed to the underside of the patient support plate 103, or insert-moulded or otherwise incorporated into the structure of the patient support plate 103.
Once the patient support plate and the thrust spacer have located one another, they can be retained in position by a reversible retaining mechanism. One such mechanism is illustrated in
An alternative reversible retaining mechanism would use a two or three-stage dual-claw reversible latch and striker bolt, similar to those used in car doors, such as that shown in
A further alternative reversible retaining mechanism is illustrated in
The patient support plate 103 is in this case furnished with a distally projecting tongue 510, which slides beneath the thrust spacer 212 as the two parts are brought into engagement. This tongue 510 has a vertical latching bore 512 which, when the thrust spacer 212 and the patient support plate 103 are properly engaged, is in alignment with the latching rod 500, thus allowing the latching rod 500 to drop into the latching bore 512. As can be seen from
For reasons that have already been discussed, it may be advantageous to provide an instrument tray that can be reversibly attaching to the reaction post. This may be achieved using a tubular extension on the bottom of the instrument tray and a bayonet or similar fitting by means of which it can be affixed to the top of the reaction post 204.
Sandwiched between the two pieces of the swivel housing 225, 226 is a ratchet gear 234 having upper and lower arms 235, each with a lug 236 through each of which one of the fixing bolts 229 passes. The gear 234 includes a toothed, part-circular outer surface 237 and in inwardly facing tab. A shape corresponding to that of the ratchet gear is let into each of the two pieces of the swivel housing 225, 226, so as to retain the gear securely in place.
a shows upper and lower bearing blocks 238, 239 mounted on the bearing tube 233 and
The two-piece articulation housing 224 is also illustrated in
Many of the same components are shown enlarged in
As shown in
Because it has been discovered that tight tolerances will not be needed, the track 208 can be a low-beam traveller track of the kind used on sailboats and the chassis 209 can be mounted on sailboat travellers 256 with recirculating ball bearings. Suitable tracks and travellers are manufactured by Harken, Inc., and by other sailboat hardware manufacturers. When subjected to a thrust load transverse to the track, these travellers will tip in a rocking motion by an angle of 2° to 5° or more, and this may result in transverse movement of the point at which the foot receptacle is attached by at least 10 mm, sometimes 20 mm or even 25 mm or more. To take care of the misalignment that occurs between the recesses 254 in the track 208 and the pin that is raised and lowered by the cam lever 255, a number of things can be done. The first and simplest is to enlarge the recesses 254 laterally, but this requires machining of all the recesses 254. An alternative is to fix the pin against rotation, for example by a key and keyway, and then to taper the pin laterally so that it is less wide at its base than it is thick. The degree of enlargement of the recesses or of tapering of the pin will depend upon the circumstances.
As shown in
The lead screw actuator is used in the conventional way to advancing and retract the clevis 263 and pin 266 in the direction of the track 208. As shown, the lead screw is driven by a hand wheel and the clevis 263 is connected to the lead screw nut. The clevis as also rotatable relative to the lead screw mechanism about an axis substantially aligned with the predetermined path, thus allowing the limb receptacle to rotate relative to the limb support, and can be locked using a mechanism similar to that used to lock the bearing tube 233, the handle 268 for which can be seen in
In a different design, the femoral lift pad support structure could be fixed directly to the top of the vertical post so that it does not go up and down with the operating table. In this case it can be brought into effect by lowering the whole operating table and the patient using the normal controls of a typical modern operating table. This may gives a better angle with the broaches, impactors, etc.
As has already been discussed, the patient support plate 103 may be an integral feature of the operating table rather than a separate component. In either case, It may be fixed relative to the table or extendable from it.
The reaction post 204 can be constructed in two pieces, a first piece that extends up as far as the bearing tube 233, and a second piece that is screwed into the first.
With the equipment just described, an operating table can be prepared for surgery on a limb easily and quickly. The floor-standing accessory component 200 is positioned adjacent to the operating table and the notch on the patient support plate 103 is offered up to the guide channels 217 on the thrust spacer 212 to locate them relative to each other. If the patient support plate is on a separate table-mounted accessory component, then it can be offered up to the thrust spacer 212 as part of the process of attaching it to the side frame members 101, 102. If it is extendable relative to the table, however, it is easier to assemble it to the table and then to extend it towards the thrust spacer 212 of the floor-standing component.
Before the operation is performed, the patient has to be prepared, gowned, pre-medicated if necessary, sedated and anaesthetised. For a procedure involving the equipment presented here, this process will involve fitting the boot 211 to the foot of the operative leg. Velcro straps may be provided for this purpose, for example overlying a shaped carbon-fibre tongue insert 280 (
The patient is wheeled into theatre and, in the case where the patient support plate 103 is offered up to the thrust spacer 212 as part of the process of attaching it to the side frame members 101, 102, the patient will be transferred from the trolley to the operating table by use of a board in the conventional way. This is facilitated by prior removal of the second, upper piece of the reaction post 204 so that the patient can be slid across into position, and the upper piece of the reaction post 204 subsequently screwed into place. Alternatively, if the patient support plate 103 is extendable relative to the table, however, the patient can moved onto the table before the patent support plate 103 and the thrust spacer 212 are approximated. Here, it is not necessary for the upper piece of the reaction post 204 to have been removed, and indeed the reaction post 204 can be a single piece.
Next, the boot 211 is attached to the lead screw mechanism 210. At this point, the lead screw mechanism, and the carriage upon which it is mounted, may be freely movable along the track 208, or it may have been fixed in a templated position. The boot is positioned so that the end of the open channel in the retention element 264 attached to its sole is over the clevis pin 266 at the free end of the channel. Owing to the shape of the channel, accurate alignment is not critical. The boot 211 is lowered, whereupon the clevis pin 266 is guided along channel to the closed end. The clevis pin 266 pushes the retractable sprung peg 265 out of the way and then seats in the lateral terminal recess 267 at the closed end of the channel, whereupon the retractable sprung peg 265 returns to its extended position and latches the clevis pin 266 into the lateral terminal recess 267. The clevis pin 266 is free to rotate in the lateral terminal recess 267 to allow dorsiflexion and plantar flexion of the foot. The passive, non-operative leg is strapped onto its support plate 105.
The default height of the femur pad, if used, is now set with reference to the patient's anatomy. Usually, there will be at least 30 mm of movement available, or 50 mm or more in some cases. The upper part of the reaction post 204, if it has been removed, would typically be replaced at this point. The lead screw chassis 209 is fixed in position, if necessary, with the patient's leg straight.
The incision site is exposed and a self-adhesive surgical drape is applied. As before, the incision site is determined using the anterior superior iliac spine as a reference. The leg is lifted slightly to slacken the muscle tone at the front of the thigh. Typically, the foot is raised by about 15 cm, by lifting the support beam 205 about its articulation 206. An incision is made close to the intermuscular space between the tensor fascia lata and the sartorius muscle. The fascia overlying the tensor fascia lata is then incised in line with the skin incision. The intermuscular interval is developed down to the hip capsule and an anterior capsulotomy is performed to aid in visualization and femoral mobilization.
Traction is applied to the base of the boot 211 using the lead screw mechanism 210, retracting the foot by about 10 mm to 20 mm. The surgeon makes a note of the muscle tone or the subjective amount of force applied to the hand-wheel to estimate the amount of traction applied. He also zeroes the display of the digital position display device 271 that is attached to the carriage.
With the traction applied the femoral neck osteotomy is performed with the applied traction helping complete, and opening, the osteotomy of the femoral neck. Once the final neck cut has been made at the preoperatively planned osteotomy level the foot is externally rotated to achieve, say, 45° of external rotation at the hip. This exposes the cut surface of the head aiding the insertion of a cork screw to remove the femoral head. Distraction of the leg is applied using the hand wheel and external rotation, using the rotation handles 269 on the lead screw mechanism 210.
With the femoral head removed, the acetabulum is prepared. Exposure can be helped by placing the leg in neutral rotation and abducting the limb towards the midline by swivelling the beam 205 about the reaction post 204.
Once the acetabular component is inserted, the traction is released and the leg is lowered to the floor using the pawl release handle 253 to release the pawl 249 from the gear wheel 234, allowing the beam 205 to be lowered against the upward restoring force of the gas strut 207. By swivelling the beam 205 about the reaction post 204, the leg is adducted by, for example, 12 cm at the foot towards the passive leg. Again, using the rotation handles 269 on the lead screw mechanism 210, the leg is positioned in 45° of external rotation at the knee to expose the proximal femur. In this position, the foot might be 180°-270° externally rotated. The femoral lift pad 272 is at this point progressively lifted to raise the proximal femur until the osteotomy plane can be reached through the skin incision.
A wedge of cancellous bone is removed from the cut end of the femur, creating an entry into the femoral canal. Broaching is then performed with progressive broach sizes, beginning with a smaller broach than the planned prosthesis. Once the final broach is in place, a process of trial reduction is performed. The appropriate neck trial is placed in a hole on the upper face of the broach. An appropriate femoral head trial is selected and assembled for trial reduction. The process of trial reduction involves manipulation of the beam 205 to lift the leg to a neutral position applying traction and internally rotate the foot, knee and hip using the rotation handles 269. After the components are selected, the hip is dislocated by applying traction and external rotation, as described before, and a bone hook around the trial neck. The trial components are removed, along with the broach.
The appropriate femoral stem is chosen and placed into the prepared broach cavity. The femoral stem is impacted and another trial reduction can be performed with the final femoral stem and the femoral head trial. At this point, the surgeon uses the hand wheel to apply a subjectively similar amount of traction as was applied when the display of the digital positioning device 272 was zeroed, and checks the reading on the device. If the reading shows a figure greater than +/−10 mm, or such figure as the surgeon may select, different component may have to be chosen. With this done, the chosen femoral head component is placed onto the taper of the femoral stem and secured using an impactor or, in the case of a ceramic head, by hand. The hip is reduced and a final check of leg length, and hip motion and stability should be made. The incision is then closed and the procedure is complete. All implant positions are checked using image intensification.
A bilateral version of the floor-standing component may be constructed as shown in
The handed table-mounted component can also be improved for greater convenience when a bilateral hip operation is to be performed. For example, the table-mounted component 100 of
The stationary portion 401 includes a pair of countersunk slots 407, each of which is designed for two or more bolts to pass through and be bolted into hangers (not shown) that can be similar to the hangers 106 of
Each of the movable portions 402 has its own leg support plate 408 and this plate is movable from the stowed position shown in
With side frame members of this improved design, the process of preparing the patient for surgery can be substantially improved, even when bilateral surgery is not needed. Having both side frame members and their leg support plates deployed at the outset enables the patient to be moved from a trolley to the operating table so that he ends up with one leg on each leg support plate. This is done before the floor-standing component is offered up to the table-mounted component and typically the patient will already be wearing the boot on the foot of the operative leg. Once the floor-standing component has been wheeled into place and coupled to the table-mounted component, the patient is repositioned, the boot is coupled to the carriage on the limb support and the leg support plate and side frame member upon which the operative leg had been resting are stowed. It is a significant advantage to be able to reposition the patient while both legs are supported, especially because it reduces the risk of injury to those who are responsible for the repositioning.
These side frame members also permit the assembly to be reconfigured during bilateral surgery by stowing one of the side frame members and deploying the other, and then just reversing the patient support plate 103. A further improvement uses a symmetrical patient support plate with bilateral cut-aways, so there is no need to reverse this component either.
As is best seen in
The adjustment knob 416, slot 417 and the eccentric mounting of the roller 414 on the spindle 420, together with the angular positioning features, enable the position of the femoral pad defined by the roller 414 to be set both horizontally and vertically, as desired. Thus, it can be used to raise the proximal end of the severed femur to provide access to the femoral canal. The roller that is on the non-operative side may be stowed in a retracted position or may be positioned flush with the upper surface of the patient support plate 413.
As shown in
A second extension 560 of the mounting bracket 548 houses a rotatable control knob 562, rotation of which will turn a pulley 564 mounted on a common spindle 566. A belt (not shown) links this pulley to a second pulley on the roller spindle, so that rotation of the control knob 562 also rotates the roller 554 about its eccentric mount. The pulley 564 that rotates with the knob 562 is typically one third the diameter of that on the roller spindle, and this, together with friction in the rotation of the knob 562 may be enough to retain the roller in the desired angular position. Alternatively, a ratchet mechanism or sprag clutch could be used to achieve the desired effect.
Number | Date | Country | Kind |
---|---|---|---|
1115391.3 | Sep 2011 | GB | national |
1118051.0 | Oct 2011 | GB | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/GB2012/052197 | 9/6/2012 | WO | 00 | 4/11/2014 |