The present invention is directed to minimally invasive surgery, and more particularly to an acetabular prosthetic cup impactor tool for use in minimally invasive hip replacement surgery.
Approximately 200,000 hip replacements are performed each year in the United States and the number is expected to continue to grow as the population continues to age. The usual reasons for hip replacement are osteoarthritis, rheumatoid arthritis and traumatic arthritis, all of which can cause pain and stiffness that limit mobility and the ability to perform daily living activities. Hip replacement surgery is usually performed where other measures (e.g. physical therapy, medications, and walking aids) are unable to overcome the chronic pain and disability associated with these conditions.
Obesity is an increasingly common health concern in the United States. According to the Center for Disease Control and Prevention (CDC), about one third of the U.S. population is obese. Studies have suggested that obesity is linked to the development of joint ailments, particularly of the hip and knee. These studies disclosed, for example, that obesity increases the risk for developing osteoarthritis in the hip and the knee, and suggest that obesity plays a role in initiating and accelerating hip and knee osteoarthritis. The development of osteoarthritis occurs either directly by the increased load on a joint or indirectly because obesity is associated with a variety of metabolic disorders. Additionally, the added weight of an obese person contributes to the stresses that are applied to a person's joints thereby increasing joint wear, and in so doing accelerating the need for replacement. Therefore, there is an increasing need to address joint ailments for obese patients as well.
Various techniques are used by orthopedic surgeons to perform hip replacements. These include the following approaches: anterior, antero-lateral, lateral, postero-lateral and posterior. The posterior and postero-lateral approaches account for approximately 60%-70% of hip replacement surgeries.
Traditional hip replacement surgery involves an open surgical procedure and extensive surgical dissection. However, such procedures require a longer recovery period and rehabilitation time for the patient. The average hospital stay for open hip replacement procedures is 4-5 days, followed in most cases by extensive rehabilitation.
More recently, there has been considerable interest and research done in Minimally invasive Surgery (MIS), including the use of MIS procedures in connection with hip replacement surgery. In comparison with the traditional open surgical approach, MIS hip replacement surgeries involve fewer traumas to the muscles surrounding the hip joint. Specifically, fewer muscles that help to stabilize the hip joint are cut in MIS hip replacement surgeries, reducing the risk of dislocation of the hip surgery and speeding recovery. Patients spend less time in the hospital and return to normal life activities more quickly.
MIS approaches use smaller surgical openings, which require specialized instruments to perform hip replacement procedures. As such, these MIS procedures are beneficial since they are less traumatic to the body. However, these MIS procedures are particularly difficult to perform with obese patients. The increased body mass and overall tissue volume of obese patients add additional complications in performing MIS procedures, particularly in accessing the surgical site.
In these cases, the incision is especially deep as there are thicker and deeper masses of soft tissue. Traditional acetabular cup impactors provide some clearance of soft tissue. However, traditional impactors provide inadequate clearance particularly when performing a MIS procedure on an obese patient. Accordingly, there is a need for an improved impactor tool for use in MIS orthopedic procedures (e.g., hip replacement surgery) with obese patients that addresses some of the shortcomings in the existing surgical impactors noted above.
In accordance with one embodiment, an orthopedic cup impactor for use in minimally invasive hip replacement surgical procedures is provided. The impactor comprises a handle, residing at a proximal end portion and a cup engagement sub-assembly located at a distal portion. A shaft resides therebetween. The shaft portion is designed with a large radius of curvature that provides added clearance when inserting the impactor in obese patients. The shaft portion is further designed with a curved underside surface and a planar top surface with beveled side edges. These features aid in the insertion of the impactor and provide surfaces to aid in the leverage of the tissue.
In accordance with another embodiment, the impactor of the present invention features an offset between the handle portion and the distal portion. The offset between the handle portion and the distal end allows for a much deeper insertion of the cup impactor into obese patients than traditional impactors with obese patients.
In accordance with an additional embodiment, the impactor of the present invention features a shaft with a curved cross-section. This feature enables the impactor access into an obese patient with increased efficiency. Furthermore, the shaft's curved cross-section helps to retard tissue necrosis.
In accordance with yet another embodiment, the impactor features a cup engagement subassembly comprising a drive shaft having multiple degrees of freedom. This drive shaft design feature, comprising a series of “U” and “H” joints, provides full rotation at differing bend angles when inserting an orthopedic implant. Furthermore, in yet another embodiment, the drive train may be designed to be removable from the cup impactor. Such a feature allows for efficient and thorough cleaning of the drive train after a surgical procedure.
Now turning to the figures,
The cup impactor 10 has an impactor length 22 and an impactor height 24 (
In an embodiment, the shaft 20 is curved between the handle 12 residing at the proximal end 14 and the distal end 19 of the impactor 10. Preferably, the shaft 20 is curved similarly to that of an arc 26 with an apex 28 positioned at about its maximum height. In a preferred embodiment, the arc 26 has a radius of curvature 30 that ranges from about 10 cm to about 20 cm as measured with respect to an inner surface 32 thereof.
The shaft 20 preferably has a planar top surface 34. Beveled top side edges 36, 38 transition from the top surface 34 to respective left and right sidewalls 40, 42 of the shaft 20 (
In a preferred embodiment, the inner surface 32 has curved inner surface side edges 50, 52. These side edges 50, 52 are designed such that they fluidly transition into the left and right sidewalls 40, 42 of the shaft 20, as illustrated in
Alternatively, the shaft 20 could be constructed such that it has a curved cross-section and more preferably, a round cross-section. As such, the shaft 20 may have a diameter that ranges from about 1 cm to about 10 cm. The curved cross-section of the shaft 20 is beneficial because it reduces the physical resistance of the cup impactor 10 as it is inserted within the body of a patient. Reduced resistance is especially beneficial when the impactor 10 is inserted within an obese human body of a large mass and volume. The curved surfaces of the impactor 10 allow the user to turn and rotate the instrument more efficiently. Furthermore, the arc design of the shaft 20 provides for improved access to the hip area of the patient.
In a preferred embodiment, the handle 12 is positioned such that it is about coplanar with that of the distal end 19 of the impactor 10. As illustrated in
Furthermore, the distal end 19 of the impactor 10 may be constructed such that it is offset from longitudinal axis A-A. In an additional embodiment, a distal end offset angle 58 is established between axis C-C, an axis extending longitudinally through the center of the distal end 19 of the impactor 10, and imaginary line D-D (
It is further contemplated that the cup impactor 10 may or may not have an offset handle angle 56 or a distal end offset angle 58 or a distal end offset distance 59. Furthermore, the respective offset angles 56, 58 of the impactor 10 may be offset at angles that are similar or different from each other.
The cup engagement sub-assembly 16 comprises a drive train 60 that extends to a rod end 62 as shown in
The cavity preferably extends from the distal end 19 of the impactor 10 to a region proximate the distal end 19. The cavity 64 preferably furthermore resides within the top surface 34 of the shaft 20 of the impactor 10. In a preferred embodiment, the cavity 64 has a cavity depth 66 from about 1 cm to about 4 cm, a cavity length 68 from about 10 cm to about 20 cm and a cavity width 70 from about 1 cm to about 5 cm. Left and right cavity sidewalls 72, 74 extend along the length 68 of the cavity 64. The cavity 64 is further positioned such that it extends through the distal end 19 of the impactor 10 creating an opening 76 thereof. The opening 76 is preferably dimensioned such that at least a portion of the distal end of the cup engagement sub-assembly 16, particularly the rod 62 of the sub-assembly 16, extends therethrough. In a preferred embodiment, the opening 76 at the distal end 19 may have a diameter that ranges from about 0.5 cm to about 2 cm. In a preferred embodiment, the cavity 64 ends at a position that is distal of the apex 28 of the middle shaft portion and provides for receiving a driver tool 78 for rotating the drive shaft with the threaded rod 62 being at an angle 80 from about 40° to about 60°, preferably at about 55° with respect to a major shaft 82 of the drive train 60.
Furthermore, the depth 66 of the cavity 64 may be designed such that it gradually increases from the proximal end 18 to the distal end 19 of the impactor 10. The maximum cavity depth 66 is achieved at the opening 76 of the distal end 19 of the impactor 10. This design feature of the cavity 64 allows for improved unobstructed motion of the drive train 60 within the cavity 64 and provides an improved means of accessing the drive train 60 within the body of the patient.
The cavity 64 further has a series of slots 84 that extend through each of the cavity sidewalls 72, 74 and bottom surface 32 of the shaft 20. These slots 84 are designed to allow for efficient and thorough cleaning of the cavity 64. Furthermore, the cavity 64 has an additional opening 86 extending through the inner surface 32 of the shaft 20 distal of the slot openings 84. This additional opening 86 is preferably positioned along a bend 88 where the distal end 19 transitions into the arc 28 of the shaft 20. The opening 86 provides for easy access to the cup engagement sub-assembly 16 to allow for efficient and through cleaning thereof.
As particularly shown in
The proximal shaft end 90 preferably has a socket 100 therewithin designed to engage the drive tool 78 (
As particularly shown in
The drive train 60 further includes an H-shaped joint 118 comprising a cylindrical intermediate section 120 supporting opposed first and second pairs of yoke plates 122, 124 and 126, 128. Respective openings 130, 132 and 134, 136 are provided in the yoke plates. A proximal pivot block 138 (
Pin 146 is received in the openings 110, 112 in the yoke plates 106 and 108 of the U-joint 102 and the opening 142 in the pivot block 138, and a pin 148 is received in the opening 142 of the pivot block 138 and the openings 110, 112 of the yoke plates 122, 124 of the H-plate 118 to thereby pivotably secure the proximal U-joint 102 to the first end of the H-joint 118. It is noted that only one of the pins 146 or 148 extends completely from one face of the pivot block 138 to the other face. As passage from one face to the other is blocked by the first pin, the other of the two pins 146 or 148 is two “half pins”.
As shown in
A distal pivot block 166, similar in structure to the proximal pivot block 138, comprises two pairs of perpendicularly opposed openings 168 and 170. Pin 174 is received in the openings 158, 160 in the respective yoke plates 154, 156 of the distal U-joint 150 and the opening 168 in the pivot block 166, and a pin 172 is received in the openings 134, 136 of the respective yoke plates 126, 128 of the H-joint 118 and opening 168 of the pivot block 166 to thereby pivotably secure the distal U-joint 150 to the second or distal end of the H-joint 118. As with the pivotable connection between the H-joint 118 and the proximal U-joint 102, only one of the pins 172, 174 extends the full width of the pivot block 166 from one face to an opposite face thereof. The other pin is provided as two partial length pins.
In this manner, the drive train 60 comprising the drive shaft 82, the proximal U-joint 102, the first pivot block 138, the H-joint 118, the second pivot block 166 and the distal U-joint 150 provides for transmission of rotational motion imparted to the proximal end of the shaft 82 to the base plate 162 and its supported rod 62.
Although the H-joint 118 is preferred, it is contemplated that the drive train 60 may be constructed without the H-joint 118. In this embodiment, the drive train 60 would comprise the drive shaft 82, the proximal U-joint 102, the first pivot block 138 and the distal U-joint 150. It is further contemplated that the drive train 60 may comprise a flexible shaft design such as wire wound shaft or a shaft that is laser cut.
The threaded rod 62 extends through the distal end 19 of the impactor 10. The threaded rod 62 preferably engages with an orthopedic implant 176. Prior to the surgical procedure, a connection between the threaded rod 62 and the orthopedic implant 176 is established. In a preferred embodiment, the threaded rod 62 is mated with corresponding grooves (not shown) of the implant 176. Once the implant is secured to the distal end 19 of the impactor 10, the implant 176 is inserted into a patient. Once the implant 176 is correctly positioned within the body, the drive shaft 82 is rotated in a reverse direction with respect to the threads of the rod 62. Typically, the rod 62 is provided with right hand threads so that counterclockwise rotation disengages the implant 176 from the impactor 10.
Additionally, a series of slots 178, as shown in
The drive train 60 may be designed without pins 98 such that it is removable from the cavity 64 of the impactor 10. A removable drive shaft 82 is beneficial in that it provides for more efficient and thorough cleaning of the cup engagement sub-assembly 16. As shown in an alternate embodiment of
Furthermore, it is contemplated that a plurality of pads may be positioned around the perimeter of the major shaft 82 of the drive train 60 and/or positioned along the inside surface of the cavity sidewalls 72, 74. These pads are designed to provide an additional interference fit within the cavity 64 such that the drive train 60 remains within the cavity 64 during the surgical procedure.
Of course, the forgoing description is that of certain features, aspects and advantages of the present invention, to which various changes and modifications can be made without departing from the spirit and scope of the present invention. Moreover, the cup impactors need not feature all of the objects, advantages, features and aspects discussed above. Thus, for example, those of skill in the art will recognize that the invention can be embodied or carried out in a manner that achieves or optimizes one advantage or a group of advantages as taught herein without necessarily achieving other objects or advantages as may be taught or suggested herein. In addition, while a number of variations of the invention have been shown and described in detail, other modifications and methods of use, which are within the scope of this invention, will be readily apparent to those of skill in the art based upon this disclosure. It is contemplated that various combinations or sub-combinations of these specific features and aspects of embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of embodiments may be made and still fall within the scope of the invention. Accordingly, it should be understood that various features and aspects of the disclosed embodiments can be combined with or substituted for one another in order to form varying modes of the discussed cup impactor embodiments.
This application claims priority from U.S. Provisional Patent Application Ser. No. 61/370,487, filed Aug. 4, 2010.
Number | Date | Country | |
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61370487 | Aug 2010 | US |