1. Field of the Invention
The present invention relates generally to medical methods and systems. More particularly, the present invention relates to a system and method of its use for distracting and pre-positioning a leg and distracting a hip joint to allow access for hip arthroscopy, open surgery, and other surgical and non-surgical procedures, as well as for examination.
To gain access to a hip joint to perform hip arthroscopy, the femoral head must be pulled away (distracted) from the socket in the pelvis. A variety of devices and protocols are known to provide such distraction. Typically, the patient is placed in a supine (lying on the back) or lateral (lying on the side) position, and the hip is anchored by attachment to a surgical table, use of a peroneal post (a post positioned between the patient's legs), or often a combination of both. Tension is then applied to the ankle or other region of the leg, with the leg straight or slightly bent to position the femoral head relative to the socket while the joint remains distracted.
While functional, these methods and systems suffer from certain shortcoming. During distraction, the nerves in and around the hip joint are stretched, and the duration of the procedure must be limited in order to prevent injury to these nerves. The pressure against the peroneal post during distraction can reduce or entirely block blood flow to the lower leg, increasing the risk of deep vein thrombosis. Additionally, most or all present distraction systems limit movement of the leg while the hip joint is distracted, thus necessitating repeated cycles of distraction and release from distraction should repositioning of the femoral head be desired. Third, to the extent existing distraction mechanisms allow the leg to pivot and rotate, the point of rotation of those system lies several inches away from the true center of the femoral head. Such displacement will disproportionately change the degree of distraction and greatly limit the physician from repositioning the leg without the need to release the joint from distraction, as discussed above.
These limitations, when taken together, not only increase the risk to the patients, they also lengthen the procedure time and make the procedure more complex for the treating physician. To overcome these difficulties, some physicians will distract the hip joint more than might otherwise be necessary. Distracting hip joint more than the procedure requires can also risk unnecessary injury to the patient.
For all these reasons, it would be desirable to provide improved methods and systems for distracting the hip during hip arthroplasty and other surgical interventions. It would be particularly desirable if the methods and systems permitted the physician to conveniently distract the hip joint at the beginning of the procedure, allow the physician to freely reposition the leg and the hip joint during the procedure while maintaining the initial distraction with minimum disturbance, and allow the physician to freely access the hip joint to perform a desired surgical procedure regardless of the degree of distraction and position of the leg and hip joint. At least some of these objectives will be met by the inventions described below.
2. Description of the Background Art
Relevant patents and published applications include: U.S. Pat. No. 7,947,006; U.S. Pat. No. 7,832,401; U.S. Pat. No. 7,677,249; U.S. Pat. No. 5,802,641; (Reissue Pat. No. 41,412); U.S. Pat. No. 5,608,934; U.S. Pat. No. 5,162,039; U.S. Pat. No. 5,025,802; US2011/0190676; US2009/0182340; US2009/0105710; and US2006/0100562.
The present invention provides methods and systems for distracting a hip joint during hip arthroscopy and other surgical and examination procedures. The methods and systems of the present invention are particularly advantageous since they allow a very simple protocol for the initial distraction of the hip joint, provide the physician with the freedom to reposition the hip joint during the surgical procedure while maintaining the initial distraction, allowing the physician to periodically relieve distraction during the procedure, and providing the physician with complete access to the hip joint with minimal or no interference from the system used for the hip distraction.
In a first aspect of the present invention, methods for distracting a patient's hip joint comprise supporting a leg on a repositionable leg support with the knee bent and the hip distracted. The leg support may be freely repositioned in a first plane, typically to allow the hip joint to move in a first plane in the medial and lateral directions (referred to as adduction and abduction) while the hip joint remains distracted and located at a fixed point of rotation. The method further comprises repositioning the leg support in a second plane perpendicular to the first plane, to allow flexion and extension of the hip joint while the hip joint remains distracted and located at the fixed point of rotation. The methods still further comprise rotating the leg support about an axis generally aligned with the femur and intersecting the fixed point of rotation, typically to provide internal and external rotation of the hip joint, while the hip joint remains distracted and located at the fixed point of rotation.
The ability of the present invention to manipulate the leg support in such a way that the hip joint is caused to rotate about a fixed point of rotation which coincides with the physiological point of rotation of the hip joint itself, opens new possibilities to physicians and provides better access to certain areas of the hip joint. The present invention allows the leg to be distracted in an anatomically easier position and the leg to then be moved to a surgically or otherwise convenient position. Such movement will lower the maximum pressure applied in the groin area during the distraction, thus minimizing the risk of injuries. The present invention further allows for rapid and precise distraction and release of distraction, which in return can reduce the total time distraction is applied during the procedure and reduce trauma to nerves and soft tissue in the hip joint area. In preferred aspects, the present invention further allows for “indexing” of the system so that, after temporary release of distraction, the system can be returned to a previous configuration to return the leg to the same position and level of distraction as before the release.
The methods may further comprise bending the knee while the leg support engages the lower leg at a point below the knee so that the lower leg acts as a lever and applies tension to the upper leg and femur to distract the hip joint. This aspect of the invention allows the physician to conveniently establish the initial hip joint distraction and further allows the initial distraction to be maintained (or re-established as noted above) by simply holding or locking the knee in the initial bent position throughout the remainder of the procedure.
In other specific aspects of this method, the leg support may be selectively locked or otherwise be prevented from movement in any one or more of the first or second planes or rotational aspects. Typically, the leg support will be selectively locked to prevent movement in the first and second planes as well as to prevent rotation while the arthroscopy or other surgical procedure is being performed. Additionally, the leg support will typically be locked in at least two of the available repositioning and rotating movements while it is being repositioned and the other of the movements. This allows the leg support and hip joint to be effectively repositioned in only one of the three degrees of freedom (while the remaining two remain locked). Alternatively, in other embodiments of the present invention, the leg support and hip joint may be repositionable and rotatable in all three movements simultaneously, allowing the hip to be freely repositioned and subsequently locked when the desired position is reached.
In a second aspect of the present invention, a method for distracting a patient's hip joint comprises immobilizing the patient's hip joint on a table with the hip joint at a point of rotation. Tension is applied to the patient's femur to distract the hip joint, and the lower leg and femur may then be pivoted on a first plane while the hip joint remains distracted and at the point of rotation, typically to allow adduction and abduction of the joint. The lower leg and femur may further be pivoted in a second plane perpendicular to the first plane while the hip joint remains distracted and at the point of rotation, typically to allow flexion and extension of the hip joint. Finally, the lower leg may be located about an axis of rotation aligned with the femur and intersecting the point of rotation while the hip joint remains distracted and at the point of rotation, typically to allow internal and external rotation of the hip joint.
The methods of the present invention may be performed with the patient lying in a supine or lateral position, and the patient will typically be positioned over a peroneal post or other structure immobilizing the patient's groin.
Tension may be applied to the femur in at least three ways. As illustrated in the drawings hereinafter, tension may be applied by flexing the knee with a location on the lower leg held against a fulcrum structure so that the knee is drawn away from the torso to apply tension to the femur (thigh or upper leg) to distract the hip joint. Usually, the fulcrum structure comprises the upper end of a leg support which holds the lower leg. Alternatively, the fulcrum structure may be moved away from the hip to push the lower leg and apply tension on the knee support to distract the hip joint. In a third embodiment, the structure may combine both methods by applying tension on the knee support while flexing the knee.
Pivoting the lower leg and the femur in the first plane typically comprises engaging the lower leg or the upper leg and moving the leg through an arc in the first plane, typically in a lateral plane when the patient is in the supine position. The leg is typically secured in a leg support which is mechanically constrained to allow movement of the leg in the first plane without moving the location of the hip joint. The leg may be engaged either by manually repositioning the leg and the leg support or by actuating a mechanism to move the leg support which in turn repositions the leg. This mechanism may be controlled by a level mechanism or other mechanical actuator extending outside of a draped area over the patient. The draped area usually extends from the patient's abdomen and over the thigh. The lever may pass through portal(s) in the drape which allow access to the hip for performing the operation.
Pivoting the lower leg and femur in the second plane typically comprises engaging the lower leg or upper leg and moving the leg to an arc in the second plane. The second plane is typically a vertical plane while the patient is in the supine position. Engaging the leg usually comprises securing the leg in a leg support which is mechanically constrained to allow movement of the leg in the second plane without moving the location of the hip joint. Engaging the leg may comprise manually repositioning the leg and the leg support or may further comprise actuating a mechanism to move the leg support which in turn moves the leg. The mechanism may be controlled by a lever or other mechanical actuator that extends out of the draped area.
Rotating the lower leg about the axis of rotation typically comprises engaging the lower leg and applying torque to the lower leg to move the lower leg in a plane normal to the axis of rotation (when the leg is bent). Engaging typically comprises securing the leg and the leg support which is mechanically constrained to allow rotation of the lower leg without moving the location of the hip joint. Engaging may further comprise manually repositioning the lower and/or the leg support, or may further comprise actuating a mechanism to move the leg support which in turn rotates the lower leg. The rotation mechanism may be controlled by a lever or other mechanical actuator that extends out of the draped area.
In the further aspect of the present invention, a system for distracting and repositioning a hip joint comprises a frame, a leg support, a first pivot assembly, a second pivot assembly, and a rotation assembly. The pivotal and rotational assemblies are arranged to define a virtual point of rotation (which is located at a point in space away from all components of the system). The frame usually has markers to help position the patient so that the virtual point of rotation is coincident with the patient's hip joint. By “coincident, is meant that the virtual point of rotation is aligned closely or identically with the physiological center of rotation of the hip joint. It will be appreciated, of course, that some variance in the locations of the virtual and physiological centers will typically be present.
The leg support comprises a lower leg attachment member and a bracket. The lower leg attachment member is pivotally secured to the bracket, thus allowing bending of the knee and distraction of the hip joint as will be described in more detail hereinafter.
The first pivot assembly mechanically couples the bracket of the leg support to the frame and constrains the leg support to travel in an arc-like path in the first plane relative to the virtual point of rotation. The first pivot assembly will typically be directly attached to the frame, but in other embodiments could be attached indirectly to the frame.
The second pivot assembly mechanically couples the bracket of the leg support to the frame and constrains the leg support to travel in an arcuate path in a second plane which is perpendicular to the first plane. The second pivot assembly will typically be attached between the first pivot assembly and the rotation assembly, although any one of positions of these three assemblies may be interchanged.
The rotation assembly mechanically couples the bracket to the frame and constrains the bracket to be rotated about an axis extending radially from the virtual point of rotation, typically being aligned with the patient's femur. The rotation assembly is typically attached between the second pivot assembly and the leg support, but as noted above the positions of these assemblies may be interchanged.
In order to allow the leg and hip joint to be both repositioned and to be locked during the procedure, each of the first pivot assembly, the second pivot assembly, and the rotation assembly will include a locking mechanism so that the pivotal and rotational movement of the leg support can be selectively allowed and prevented. The locks may be active locking assemblies or alternatively may be frictional drivers which prevent movement of the assembly when they are not actively being actuated.
Additional locks or indexing mechanisms may be provided to allow the system to be returned to a previous configuration, typically after distraction has been temporarily released and/or the leg has been temporarily repositioned. Indexing systems may be as simple as providing indicia on the components so that an initial position can be recorded and subsequently re-established based on the indices. Often, the indexing system will comprise collars, pins, locks, or other components which may be set at any system configuration and allow any one or more of the pivotal and rotational assemblies to be returned to that set configuration. For motorized systems, the indexed configuration can be recorded by the system controller and be automatically re-established at any time. Thus, a variety of manual, automatic, and programmable indexing mechanisms can be utilized alone or in combination.
A particular advantage of this system is that the virtual point of rotation may be sufficiently offset from all mechanical components of the system to allow the hip joint to remain surgically accessible during the procedure regardless of the position of the leg support. In that way, the physician may freely reposition the leg and hip joint by manipulating the leg support without limiting his or her ability to perform the desire hip arthroscopy or other surgical procedure.
The frame may be constructed as a stand-alone surgical table, but will more typically be adapted to be removably secured to existing and conventional surgical tables.
As with the repositioning and rotation assemblies, the leg support will typically comprise a lock for selectively immobilizing the leg attachment member relative to the bracket. This allows the knee to be bent at a selective angle in order to provide a desired degree of hip joint distraction and to then be locked at that position during the remainder of the procedure and/or repositioned during the procedure if a different level of distraction is desired. The leg support may also comprise an indexing mechanism as described above.
The lower leg member will be adapted so that the lower leg may be secured at different positions or locations on the lower leg member so that the knee can be raised and lowered relative to the bracket. By raising and lowering the leg relative to the bracket, a different mechanical leverage can be obtained on the knee joint and femur to allow the physician to adjust the degree of hip distraction provided when the knee joint is bent, as described in the methods above.
In a specific embodiment of the system, the first pivot assembly comprises a support arm and a linkage assembly. The linkage assembly is attached to the frame, and the support arm is coupled to the second pivot assembly. The linkage assembly allows the support arm to reposition the leg support around the virtual point of rotation in the first plane. Such movement of the leg, of course, allows the hip joint to be adducted or abducted as described above in connection with the methods.
The second pivot assembly typically comprises a linkage assembly which is attached between the first pivot assembly and the rotation assembly. The second pivot assembly allows the leg support to be repositioned in the second plane about the virtual point of rotation. Such repositioning, of course, allows the hip joint to be flex or extended as described above in connection with the methods of the present invention. The linkage assembly of the second pivot assembly may comprise a parallelogram support structure, and the second pivot assembly may further comprise a driver adapted to manipulate the parallelogram structure to effect movement of the leg support.
The rotation assembly typically comprises a rocker assembly attached between the second pivot assembly and the bracket of the leg support. A rocker assembly allows the leg support to be rotated about the axis. The rocker assembly is useful since it allows the point of attachment of the rotation assembly to be offset from the axis of the leg supported on the leg support while still having the axis of rotation be aligned with the femur of the leg.
While the system and method as described above are particularly suitable for distracting a hip and repositioning the leg while the hip remains distracted, the systems are also used for hip distraction alone and for leg repositioning alone. In particular, the system can be used without distraction to collect data, track rehabilitation, map the anatomy, examine the patient, and for other activities before, during, and after surgical intervention.
The systems of the present invention will comprise at least the first and second pivotal assemblies and the rotation assembly. These assemblies will be mechanically coupled to the main frame either directly or indirectly, i.e., in tandem. Each of the assemblies may be actuated manually, via pre-loaded springs, using motors, or in any other way that such mechanical systems may be driven. The illustrated embodiments are suitable for manual actuation but could readily be adapted for motorized and/or automatic control.
The systems of the present invention could also be adapted to be driven to apply continuous or discontinuous motion to the leg for purposes of diagnosing and/or therapy for the hip and/or the knee.
In further embodiments, the motion of any of the movable assemblies can be free or be balanced by a spring, and the ranges of motion can be limited to allow leg and joint movements over certain ranges of motion but prevent them over other ranges of movement. All systems described herein could be used for rehabilitation purposes, after certain injuries or in relation with any medical intervention in the area of the joints.
The first and second pivotal assemblies, the rotation assembly, and the distraction assembly are all movable assemblies that can be actuated in a variety of ways, including manually, utilizing preloaded springs or using motors. In one embodiment of the present invention, the movement of each one of the movable assemblies can be controlled manually by the operator.
In further embodiments of the present invention, motors can be used to move any one or all of the moveable assemblies. The range of motion for each assembly can be pre-programmed, and the systems can be used to apply continuous motion to both hip and knee joints. The motion of any of the movable assemblies can be set to be free or to be balanced by a spring, and the range of motion can be limited to allow leg movements and movement of the joints in one area but prevent movement in other areas. The embodiments as described above individually or in combination, could be used for rehabilitation purposes, after certain injuries or in relation with any medical intervention in the area of the joints.
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The abduction carriage 245 shown in
The abduction carriage 245 as shown in
A parallelogram mechanism 230 is shown in
The parallelogram mechanism 230 is shown in a position corresponding to leg extension in
Rotation support plate 210 houses two pivots 221 connecting the arms 222 of the leg rotation mechanism 220 to the upper leg length adjustment bracket 211 used to control and compensate for differences in the length of the upper leg, as shown in
The leg rotation mechanism 220 is shown in two positions relative to rotation support plate 210 of distraction frame 224 and the upper leg length adjustment bracket 211 in
Distraction assembly 200 along with distraction frame 224 are shown in positions which are to the left of the central position when viewed from atop rotational plate 210 in
Distraction assembly 200 along with distraction frame 224 are shown in positions which are to the right of the central position when viewed from atop rotational plate 210 in
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Distraction assembly 200 rotates around pivots 225 relative to distraction frame 224 and is shown in a relatively horizontal position in
Distraction assembly 200 rotates around pivots 225 relative to distraction frame 224 and is shown in a relatively vertical position, which may be the final distraction position in
The peroneal post 285 comprises components 282, 283, 287, 288 and 289 as shown in
A passive leg support subframe 265 attached to the main frame 250 is shown in
A patient placed on the PDA with a right leg to be distracted and a left passive leg is shown in
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This application claims the benefit of provisional application No. 61/454,583 (Attorney Docket No. 42628-703.101), filed on Mar. 21, 2011, the full disclosure of which is incorporated herein by reference.
Number | Date | Country | |
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61454583 | Mar 2011 | US |