Not applicable
Not applicable
Not applicable
1. Field of the Invention
The present invention relates generally to orthopedic surgery, and more particularly to a system and method for performing replacement or arthroplasty of a ball and socket joint.
2. Description of the Background of the Invention
There are two major types of ball and socket joints in human anatomy, two hip joints and two shoulder joints. There are a number of surgical approaches to repair of these ball and socket joints. For the hip joint, total hip arthroplasty (THA) or replacement surgery is used to provide increased mobility to patients who have significant problems with one or both of their hip joints, including injury, arthritis, bone degeneration, cartilage damage or loss, and the like. The classic THA surgery involves the dislocation of the hip joint following an incision to access the joint. Following dislocation of the joint, the femoral head is removed from the femur by cutting the femur through the femoral neck. The hip socket or acetabulum is then reamed out using a power tool and reaming attachment to remove the cartilage remaining within the acetabulum and to prepare the acetabulum to accept the acetabular implant component or cup. Typically, the reamer attachment is sized to prepare the acetabulum to accept a particular type of implant cup or component. The implant cup is held in place by cement, special screws and or by a mesh that accepts bone growth to firmly affix the cup to the pelvis.
The femur is then prepared by reaming the femoral canal using specialized rasps or similar instruments to shape the femoral canal to accept the fermoral stem implant. The femoral stem implant is then placed in the reamed out canal and affixed in place in a manner similar to the acetabular cup. The last step in the classic procedure is to attach a metal ball to the stem to act as the hip pivot point within the cup.
For the shoulder joint, total replacement surgery is less common, and typical replacement surgery may only replace the ball of the humerus and often does not involve any cup implant. In this case, the surgery typically will replace the ball of the humerus and sometimes make various levels of modification to the surface of the glenoid socket.
Because the relative size and configuration of the implants can affect the length and offset of the leg or arm, care must be taken in the choice of the particular implants chosen. In addition, care must be taken in reaming out the socket, whether the glenoid or the acetabulum, at an appropriate position/orientation to achieve desired kinematics. Often, prior to affixing the permanent implants in place, trial implants are placed in position to assist the surgeon to gauge the impact of the replacement surgery on the patient's mobility, range of motion, and quality of life. These issues include for the hip joint, making sure the leg length closely matches the length of the non-operative leg, making sure the offset of the replacement hip joint is satisfactory so that the appearance of the leg matches the non-operative leg, and making sure the replacement joint is sufficiently stable so that normal activity by the patient will not cause the hip to dislocate or cause the leg not to be able to properly support the patient during walking and other normal routine activities. For the shoulder, the length of the arm, the offset, and range of motion of the arm and shoulder must match the non-operative arm and shoulder and the operative shoulder must not dislocate under normal activity. One concern with the use of trial implants is that these trial devices are used after all preparation of the bone has taken place. If the trial indicates that the depth of the preparation is too great the surgeon is left with using implants of a different configuration to attempt to address the situation. This requires having a greater inventory of implants on hand before the surgery begins in order to address contingencies that may occur.
In addition, the classic surgical technique presents the surgeon with a number of other challenges. The use of surgical navigation and appropriate pre-surgical planning can minimize these challenges, but even with the use of these tools, care must be taken to insure appropriate modifications to the bone are made during the surgery. For instance with hip replacement surgery, it is necessary to prepare the acetabulum to a suitable depth to accept a certain acetabular implant cup, but at the same time avoid violating or compromising the medial wall of the acetabulum. At the same time, it is necessary to make sure that the acetabulum is prepared to properly accept the implant cup. If the cup does not sit well within the prepared acetabulum, for instance, if the prepared acetabulum is deeper than the depth of the cup or the cup can not be placed sufficiently deep within the acetabulum, the cup will either become loose over time or the pelvic structure may be damaged as the cup is impacted into place. There can be similar concerns for the shoulder if the glenoid is resurfaced or modified.
In addition to concerns relating to limb length and offset mentioned above, many surgeons may rely on mechanical guides to orient implants in position relative to the patient's anatomy, which can result in imprecise and less than optimal joint function. Lastly, the surgeon must rely on experience to assess the finished range of motion and stability of the completed joint and the consequent potential for the joint to dislocate under normal everyday activities.
One embodiment of the present invention relates to a method of performing an arthroplasty of a stem-ball and socket joint with a surgical navigation system. The method comprises the steps of digitizing landmarks to provide geometrical parameters of the joint and a limb depending there from, including digitizing aspects of a socket region and the stem of the limb; determining a range of motion parameter; and determining a soft tissue tension parameter. The method further includes the step of computing a functional goal based on landmark data, the range of motion parameter, the soft tissue tension parameter, and a database of potential implants. Next, the method includes solving for an optimal socket orientation to minimize impingement taking into account stability constraints based on an identified center of rotation of the socket; choosing an implant components combination and positioning to match the functional goals; solving for an optimal socket position to minimize impingement taking into account stability constraints based on an identified stem position and the identified center of rotation of the socket; and solving for an optimal components combination and positioning to match the functional goals based on the optimal socket position; In addition, the method also has the steps of solving for an optimal components combination and orientation to match the functional goals based on the optimal socket position and the identified stem position; choosing a final components combination and a final orientation of the components to match the functional goals; preparing of the joint to receive the final implant components; and installing the final implant components into the joint.
A further embodiment of the present invention is directed to a method of selecting and positioning an implant into a ball and socket joint by taking into account both geometrical parameters and soft tissue tension parameters with a surgical navigation system. The method comprises the steps of digitizing geometrical parameters and range of motion data; measuring a soft tissue tension parameter; and selecting a first socket position that provides adequate stability and minimal potential for impingement. The method further includes the steps of establishing an acceptable tolerance range from the first socket position with regard to limb length, distal/proximal displacement, and lateral/medial displacement; selecting an initial implant combination of components; and calculating and graphically displaying attributes of the initial implant combination of components and a position of the initial implant combination of components relative to a range of additional potential attributes for additional potential implant combinations of components and for additional positions of the initial combination of components. Lastly, the method includes the step of modifying the initial implant combination of components and the initial position of the initial combination of components to arrive at a final implant combination of components and a final position of the final combination of components for optimal functional properties of the joint while staying within the tolerance range.
A still further embodiment of the present invention is directed to a method of performing an arthroplasty of a joint with a surgical navigation system. The method comprises the steps of establishing and tracking a functional plane of the joint relative to a predetermined at rest position; and establishing and tracking a plumb line relative to the functional plane. The method further includes the steps of preparing the joint to receive implant components; choosing implant components that minimize impingement and maximize range of motion; and inserting the chosen implant components into the prepared joint.
Other aspects and advantages of the present invention will become apparent upon consideration of the following detailed description.
Functional driven positioning of one or more implant components takes into account range of motion and muscular tension to establish the orientation and position of the implants. In a conventional surgical procedure, orientation and positioning of an implant component may involve adhering to standardized position values that are not patient-specific and hence may result in less than optimal positioning and orientation from a functional standpoint. For example, in a conventional hip replacement procedure, a surgeon may adhere to a standard value of 20° of anteversion and 45° of inclination relative to the anatomical frontal plane for a cup implant as is well known in the art. Available medical literature shows that the anatomical references used during a surgical procedure for these fixed average values of 20° and 45° may be somewhat arbitrary because these values are averages and may not correspond to the optimal function of the joint. For example, for a patient having a tilted pelvis when standing upright, the conventional approach would dictate an amount of cup inclination and anteversion based on the frontal plane of the pelvis as measured while the patient is lying down without taking into account that when the patient stands the pelvis is flexed.
To achieve the optimum results in a joint arthroplasty procedure for a ball and socket joint, there are several interrelated goals the surgeon strives for. The first goal is sufficient stability of the socket. For example in a hip procedure, an acetabular cup implant must be well seated in the bone and positioned and oriented appropriately to withstand years of loading. The cup implant must not be bored so deeply into the pelvic wall to compromise the structural integrity of same. Alternatively, in a shoulder procedure, the glenoid 154 (shoulder socket shown in
The second goal is minimal tendency or risk of impingement/dislocation. For example, it is desirable in a hip procedure to position and orient a cup implant such that a neck implant does not impinge against a rim of the cup implant during the expected normal movement of the limb, potentially causing the ball of the neck implant (which ball fits within the cup implant) to dislocate (i.e., pop out) from the cup implant during expected normal movement of the limb. These first two goals of (1) stability and (2) minimal risk of impingement/dislocation are typically the most important considerations for the socket because insufficient stability and a tendency for impingement and dislocation could severely impair the function of the joint.
There are additional goals or factors to consider, discussed hereinbelow, that are also affected by the orientation and positioning of the socket or socket implant. Once the surgeon has determined a first position and orientation of the socket/socket implant that would be sufficient from a stability and impingement/dislocation standpoint, the surgeon may consider how much she may reasonably deviate from this first socket position/orientation to achieve the additional goals. The surgeon may then fine-tune or tweak the positioning and orientation from the first position/orientation to achieve or at least approach the additional goals.
The additional goals include a third goal of arriving at a socket position and orientation that results in matching the lateral-medial displacement of the operative limb to the non-operative limb (i.e., the contralateral side) or at least approaching lateral-medial displacement similar to the contralateral side. A fourth goal includes positioning/orienting the socket such that the distal-proximal placement of the operative limb matches or approaches the contralateral side. A fifth goal is to match the length of the operative limb to the contralateral side. A sixth goal includes matching (or approaching) the center of rotation of the contralateral side. It should be noted that matching the center of rotation to the contralateral side may be considered less important than matching the leg length or other of the goals. For example, the surgeon may establish an arbitrary center of rotation/first socket position that ignores precisely matching the socket position of the contralateral side but provides optimal stability for the socket. As discussed hereinbelow, the surgeon may then use left over degrees of freedom to fine-tune from the first socket position to achieve an optimal function and desired limb length A seventh goal is matching the kinematics of contralateral side (i.e., similar range of motion). However, depending on the anatomical constraints of the patient matching the kinematics may be less important than other of the goals. As should be evident from the “approaching” language above, the surgeon may have to compromise slightly or substantially on one or more of these additional goals in order to arrive at position and orientation of the socket that is optimal regarding the majority of the first through seventh goals. The degree to which one or more of the seven goals need be compromised may depend in large part on the anatomical constraints of the patient.
Besides socket positioning/orienting, the selection of implant(s) affects the aforementioned goals. The particular dimensions (i.e., size) and geometry (e.g., angles) of the selected implant(s) are an important consideration relative to achieving one or more of the first through seventh goals. For example, in a hip procedure, a particular implant may have a neck length longer or shorter than other available implants. The particular length of the neck affects the lateral-medial and distal-proximal displacement of the operative femur relative to the contralateral side. In addition, the particular angle the neck makes with a femoral stem implant affects the lateral-medial and distal-proximal displacements.
Referring to
The surgeon may then establish an acceptable tolerance range from the first socket position/orientation within which the surgeon feels comfortable adjusting from the first socket position/orientation. Referring to
The soft tissue tension data are collected by the system by any suitable pressure sensor built into the acetabular cup, or into the femoral head or neck implant of the trial implants. The pressure sensors are conventional strain gauges that are built into the trial components. These trial components enable the surgeon to test the configuration to confirm that the optimum solution is in fact optimal for the patient. The pressure values can be transmitted to the system 100 wirelessly and can be related to the respective limb position. As part of the process of gathering soft tissue tension data, the surgeon may use trial implant components that have not only the above pressure sensors but motorized parts that adjust one or more implant features such as neck offset/length or neck angle, and the system 100 could calculate soft tissue tension parameters relative to various values of neck length or neck offset angle. During movement of the limb 122, the system is provided with lift-off data upon the system detecting displacement of the center of rotation of the joint 124 as is well known in the art.
The performance of trials with a pressure sensor may be conducted after the system 100 determines the first socket position/first implant(s). For example, the surgeon could manipulate the neck angle and/or neck length and display a further function graph similar or identical to the graph 130 of
A typical scenario would be as follows. The surgeon captures preoperative range of motion. The surgeon prepares the acetabulum or glenoid and places a swivel trial. The surgeon reams a trial broach into the femur. According to a first option or procedure, the surgeon reams to a final position in terms of depth and anteversion, thus decreasing the degrees of freedom for later optimization. The surgeon next places a trial neck and head and performs a further range of motion. The system 100 then derives an optimal neck angle, head offset, anteversion, and inclination of cup.
According to a second option or procedure, the surgeon places a preliminary broach in place rather than reaming to the final position in terms of depth and anteversion. According to this second option or procedure, maximum degrees of freedom are provided because the position is not final. The surgeon next tests the trial neck and head and performs a range of motion analysis therefor. The system 100 derives an optimal stem anteversion and all of the above. The surgeon next verifies the proposed femoral components. Verification includes the assembly of the selected components in situ or if a automatically adjustable device is in place then the degrees of freedom of the device are adjusted accordingly. The trial neck with proposed angle and head with proposed offset are mounted manually. The surgeon performs one or more smart trials, utilizing motorized implant components as discussed above to adjust the proposed neck angle, offset, and anteversion in situ. Additional force data is collected, allowing further transformations and further graphical displays such as the graphical display 130 by the system 100, and thus allowing the surgeon to fine-tune the implant component(s) geometry. The trial implant could include an extensible femoral neck and a force sensor that communicates force data to the system so that during registration of the second movement the surgeon can assess the affect of soft tissue tension on the neck length. The surgeon may vary the neck length in the performance of movement analyses and transmit force data for various neck lengths. Based on the acquired force data, the surgeon can use the system to determine an optimal neck length that provides suitable tension while also resulting in an offset that is cosmetically acceptable (i.e., within appropriate geometrical parameters). Finally, the surgeon navigates final components to the optimized positions. Depending on surgeon preferences, the above options or procedures can differ in order and degrees of freedom available for optimization.
Sometimes initial kinematics of the patient are taken into account. They can be used as a reference to document the improvement of the surgical measure. Sometimes, when the disease permits, it will be desirable to reestablish center of rotation, range of motion and soft tissue tension. The most common situation though will be to try to optimize the ipsilateral side regardless of the initial state such that the surgeon establishes an arbitrary first socket position/center of rotation as discussed above. In cases where reestablishment of the original center of rotation is desired, a first kinematic analysis is performed by moving the contralateral limb about the joint to obtain first kinematic data and the operative limb 124 is moved about the joint 122 to obtain second kinematic data that is compared to the first kinematic data.
Referring to
Referring to
Referring to
Referring to
An easy method to establish the plumb line plane P intraoperatively, uses one or more suitable levels 230 to level an operating table 235. The table 235 includes one or more suitable tracking markers 240 to enable the system to track the position and orientation of the table 235. The table 235 is moved from a first height position A to a second height position B, and the table position is digitized at each of these positions A and B to establish the plumb line plane P. As discussed before a previously established functional frontal plane can now be tracked relative to the plumb line plane. The position and orientation of this plane may then be assessed relative to the plumb line plane P as illustrated in
For shoulders, the reference position is a neutral stance. This provides information relative to the appropriate positioning of the shoulder joint to maximize post operative flexibility and stability.
The surgical navigation system 100 includes appropriate software and circuitry to execute the disclosed functions. The computer program of the system may include any suitable user interface screens for executing the various features discussed herein.
Numerous modifications to the present invention will be apparent to those skilled in the art in view of the foregoing description. For example, virtual trials may be performed at any time during an arthroplasty procedure such as before of after dislocation of the limb from the joint. Accordingly, this description is to be construed as merely exemplary of the inventive concepts taught herein and is presented for the purpose of enabling those skilled in the art to make and use the invention and to teach the best mode of carrying out same. The exclusive rights to all modifications which come within the scope of the appended claims are reserved.
Number | Name | Date | Kind |
---|---|---|---|
4323459 | Quinlan | Apr 1982 | A |
4396945 | DiMatteo et al. | Aug 1983 | A |
4722056 | Roberts et al. | Jan 1988 | A |
4869247 | Howard, III et al. | Sep 1989 | A |
4923459 | Nambu | May 1990 | A |
4945914 | Allen | Aug 1990 | A |
4951653 | Fry et al. | Aug 1990 | A |
4991579 | Allen | Feb 1991 | A |
5016639 | Allen | May 1991 | A |
5094241 | Allen | Mar 1992 | A |
5097839 | Allen | Mar 1992 | A |
5119817 | Allen | Jun 1992 | A |
5142930 | Allen et al. | Sep 1992 | A |
5178164 | Allen | Jan 1993 | A |
5186174 | Schlondorff et al. | Feb 1993 | A |
5197488 | Kovacevic | Mar 1993 | A |
5198877 | Schulz | Mar 1993 | A |
5211164 | Allen | May 1993 | A |
5222499 | Allen et al. | Jun 1993 | A |
5230338 | Allen et al. | Jul 1993 | A |
5309101 | Kim et al. | May 1994 | A |
5383454 | Bucholz | Jan 1995 | A |
5394875 | Lewis et al. | Mar 1995 | A |
5397329 | Allen | Mar 1995 | A |
5494034 | Schlondorff et al. | Feb 1996 | A |
5515160 | Schulz et al. | May 1996 | A |
5551429 | Fitzpatrick et al. | Sep 1996 | A |
5575794 | Walus et al. | Nov 1996 | A |
5590215 | Allen | Dec 1996 | A |
5595193 | Walus et al. | Jan 1997 | A |
5617857 | Chader et al. | Apr 1997 | A |
5622170 | Schulz | Apr 1997 | A |
5638819 | Manwaring et al. | Jun 1997 | A |
5665090 | Rockwood et al. | Sep 1997 | A |
5682886 | Delp et al. | Nov 1997 | A |
5690635 | Matsen, III et al. | Nov 1997 | A |
5695501 | Carol et al. | Dec 1997 | A |
5704897 | Truppe | Jan 1998 | A |
5711299 | Manwaring et al. | Jan 1998 | A |
5730130 | Fitzpatrick et al. | Mar 1998 | A |
5752513 | Acker et al. | May 1998 | A |
RE35816 | Schulz | Jun 1998 | E |
5769789 | Wang et al. | Jun 1998 | A |
5797924 | Schulte et al. | Aug 1998 | A |
5799099 | Wang et al. | Aug 1998 | A |
5851183 | Bucholz | Dec 1998 | A |
5871445 | Bucholz | Feb 1999 | A |
5880976 | DiGioia III et al. | Mar 1999 | A |
5891034 | Bucholz | Apr 1999 | A |
5891157 | Day et al. | Apr 1999 | A |
5907395 | Schulz et al. | May 1999 | A |
5916164 | Fitzpatrick et al. | Jun 1999 | A |
5921992 | Costales et al. | Jul 1999 | A |
5954648 | Van Der Brug | Sep 1999 | A |
5970499 | Smith et al. | Oct 1999 | A |
5987349 | Schulz | Nov 1999 | A |
5995738 | DiGioia et al. | Nov 1999 | A |
6073044 | Fitzpatrick et al. | Jun 2000 | A |
6081336 | Messner et al. | Jun 2000 | A |
6112113 | Van Der Brug et al. | Aug 2000 | A |
6205411 | DiGioia, III et al. | Mar 2001 | B1 |
6385475 | Cinquin et al. | May 2002 | B1 |
6430434 | Mittelstadt | Aug 2002 | B1 |
6453190 | Acker et al. | Sep 2002 | B1 |
6569169 | De La Barrera et al. | May 2003 | B2 |
6595997 | Axelson, Jr. et al. | Jul 2003 | B2 |
6676706 | Mears et al. | Jan 2004 | B1 |
6695850 | Diaz | Feb 2004 | B2 |
6702821 | Bonutti | Mar 2004 | B2 |
6711431 | Pratt et al. | Mar 2004 | B2 |
6827723 | Carson | Dec 2004 | B2 |
6859661 | Tuke | Feb 2005 | B2 |
6877239 | Leitner et al. | Apr 2005 | B2 |
7275218 | Petrella et al. | Sep 2007 | B2 |
7427200 | Noble et al. | Sep 2008 | B2 |
7657298 | Moctezuma de la Barrera et al. | Feb 2010 | B2 |
7662113 | Pearl et al. | Feb 2010 | B2 |
20010034530 | Malackowski et al. | Oct 2001 | A1 |
20020133160 | Axelson, Jr. et al. | Sep 2002 | A1 |
20030153829 | Sarin et al. | Aug 2003 | A1 |
20030153978 | Whiteside | Aug 2003 | A1 |
20040034313 | Leitner | Feb 2004 | A1 |
20040102866 | Harris et al. | May 2004 | A1 |
20040105086 | Leitner et al. | Jun 2004 | A1 |
20040106861 | Leitner | Jun 2004 | A1 |
20040106869 | Tepper | Jun 2004 | A1 |
20040106916 | Quaid et al. | Jun 2004 | A1 |
20040117026 | Tuma et al. | Jun 2004 | A1 |
20040147927 | Tsougarakis et al. | Jul 2004 | A1 |
20040152972 | Hunter | Aug 2004 | A1 |
20040171924 | Mire et al. | Sep 2004 | A1 |
20050065617 | Moctezuma de la Barrera et al. | Mar 2005 | A1 |
20050101966 | Lavallee | May 2005 | A1 |
20050113720 | Cinquin et al. | May 2005 | A1 |
20050119661 | Hodgson et al. | Jun 2005 | A1 |
20050203384 | Sati et al. | Sep 2005 | A1 |
20050234332 | Murphy | Oct 2005 | A1 |
20060235538 | Rochetin et al. | Oct 2006 | A1 |
20070179626 | de la Barrera et al. | Aug 2007 | A1 |
Number | Date | Country |
---|---|---|
39 04 595 | Apr 1990 | DE |
0 326 768 | Aug 1989 | EP |
0 705 075 | Apr 1999 | EP |
0 705 074 | May 2000 | EP |
1399707 | Mar 2004 | EP |
1417941 | May 2004 | EP |
3-267054 | Nov 1991 | JP |
06-282889 | Oct 1994 | JP |
06-282890 | Oct 1994 | JP |
WO 9005494 | May 1990 | WO |
WO 0039576 | Jul 2000 | WO |
WO 02063236 | Aug 2002 | WO |
03041566 | May 2003 | WO |
WO 03041611 | May 2003 | WO |
03065949 | Aug 2003 | WO |
WO 03073951 | Sep 2003 | WO |
WO 03079940 | Oct 2003 | WO |
WO 2004014219 | Feb 2004 | WO |
WO 2004030556 | Apr 2004 | WO |
WO 2004030559 | Apr 2004 | WO |
2005072629 | Aug 2005 | WO |
Number | Date | Country | |
---|---|---|---|
20060095047 A1 | May 2006 | US |