Patients often require a total hip arthroplasty in the event of arthritis, instability, joint pain, femoral fracture, and the like that a patient may experience. A typical hip prosthesis used in a total hip arthroplasty includes a stem which functions as the base for proximal head replacement of the femur. Stems generally require a resection of the femur in preparation for implantation. With metaphyseal/diaphyseal engaging stems, a surgeon would typically resect a significant amount of good quality healthy bone stock to fit the stem into the femoral canal. Due to the loss of such healthy bone stock, press-fitted cement-less stems are inserted deeper into the canal than may be required otherwise in order to generate adequate fixation and stability. In this regard, conventional stems load the femur relatively distally, and therefore extend deep into the femoral canal to achieve sufficient initial stability and long-term fixation in the metaphyseal region. Consequently, the conventional stem often requires significant preparation of narrow femoral canals up to depths very often exceeding 100 millimeters. Such preparation typically involves extensive instrumentation, such as a family of sequentially increasing sizes of broaches, to prepare the femoral canal up to the required depth. Such instrumentation not only leads to excess equipment used in surgery, but may also lead to decreased stability due to repetitive insertion and removal of broaches of increasing size. Further, in order to be able to present such instruments to the femoral canal, the standard level of resection is distal of the femoral neck such that it leaves little to no bone remaining at the femoral neck. Therefore, further improvements are desirable.
The present disclosure describes a hip prosthesis having a curved, tapering stem including rasp teeth on a distal-lateral surface capable of self-broaching upon implantation. The stem may extend into the canal slightly past the level of the lesser trochanter, having a length relatively shorter than the conventional tapered wedge and other anatomic stems. The disclosed stem provides more anatomic loading on the medial calcar region of the proximal femur and promotes preservation of bone stock in the femoral neck during a total hip arthroplasty. The implant as described herein provides several benefits that improve the outcome of the procedure, such as a reduced moment arm, improved implant load distribution via greater anatomic loading on the implant, reduced potential for trochanteric fractures, greater head offset and increased joint stability, improved bone remodeling due to less bone resorption in the proximal femur, potential for reduced blood loss, greater preservation of soft tissue in the trochanteric region and potential to reduce thigh pain and improve the timing and experience of rehabilitation and recovery for the patient. Another potential benefit is that a greater amount of bone preserved in the neck may enable easier revisions for patients in the event of failure because there remains good bone stock proximal to the conventional resection level, which can subsequently be removed and revised with a conventional stem.
Preparation of the neck region of the femoral canal proximal to the level of the lesser trochanter may be performed robotically (e.g., with a rotary cutting tool such as a burr that removes cancellous bone) based on a CT-based 3D plan of the patient, which would enable initial stem insertion into the canal. The stem is intended to be self-broaching to simplify the surgical workflow. In other words, the stem itself can carve its own path in the bone and may not require initial shaping of the canal with other instruments, such as an associated family of sequentially increasing sizes of broaches. This may be achieved with the help of the proximal robotic preparation as well as one or more cutting rasp teeth features disposed on a relief surface on the distal-lateral portion of the stem, as will be discussed below in greater detail. For some patients, preparation of the neck region of the femoral canal may include the formation of a pilot hole using an instrument such as a curved awl, which is also discussed below in greater detail.
In certain embodiments, a femoral implant may include a spherical head positioned a proximal end of the implant. The femoral implant may further include a neck coupled to the head, the neck extending distally from the head. The femoral implant may further include a stem extending distally from the neck. The stem may have a medial side adapted to face a medial extent of the femur and a lateral side adapted to face a lateral extent of the femur when implanted therein. The medial side may have a concave curvature and the lateral side may have a convex curvature. The stem may include a plurality of teeth disposed on a distal portion of the lateral side of the stem such that the stem is configured to be self-broaching when implanted into the femur. The plurality of teeth may be arranged in a plurality of columns on the lateral side. The plurality of teeth may be arranged in an array forming straight rows and columns of teeth on the lateral side, the teeth spaced equally apart from one another. The plurality of teeth may be arranged on the lateral side in an array having a plurality of rows wherein the teeth of every other row are aligned in columns and the teeth of adjacent rows are offset.
The stem may include a flange between the distal end of the neck and the proximal end of the stem, the flange having a larger cross-section than the neck defining a peripheral lip. The proximal portion of the stem may include a porous structure. The porous structure may be positioned more proximally on the lateral side of the proximal stem portion than the medial side of the proximal stem portion. The medial side may have a transition point where the medial side changes from the first radius of curvature to the second radius of curvature, and the stem may define a transition plane between the porous structure and a non-porous portion of the stem, wherein the transition point may be located proximal to the transition plane. The stem may include an anterior side adapted to face an anterior extent of the femur and a posterior side adapted to face a posterior extent of the femur, and the stem may taper in both the medial-lateral direction and the anterior-posterior direction as the stem extends distally. The plurality of teeth may be disposed on a relief surface located on the lateral side of the stem. The relief surface may extend toward a central axis of the stem in a distal direction. The relief surface may intersect the convex curvature of the stem. The relief surface may be located at a relief portion of the stem. The relief portion of the stem may have a polygonal cross section. A distal portion of the stem may be polished. The concave curvature of the stem may extend from a proximal extent of the stem to a distal extent of the stem. The neck and stem may be monolithic, and the spherical head may be a modular piece coupleable to the neck and stem. The medial side of the stem may define a first radius of curvature on a proximal portion of the medial side of the stem. The medial side may further define a second radius of curvature on a distal portion of the medial side of the stem. The lateral side of the stem may define a third radius of curvature. The second and third radii of curvature may be different than the first radius of curvature.
In certain alternative embodiments, a femoral component may include a spherical head positioned at a proximal end of the implant. The femoral implant may further include a neck coupled to the head. The neck may extend distally from the head. The femoral implant may further include a stem extending distally from the neck. The stem may have a medial side adapted to face a medial extent of the femur and a lateral side adapted to face a lateral extent of the femur. The medial side may have a concave curvature and the lateral side may have a convex curvature. The concave curvature may be defined by a first and a second radius of curvature and the convex curvatures may be defined by a third radius of curvature. The stem may further include a relief surface intersecting the convex curvature and extending distally therefrom. The relief surface may have a plurality of teeth such that the stem is configured to be self-broaching when implanted into the femur.
In certain embodiments, a method of implanting a femoral prosthesis may include resecting a femur through a neck thereof between a head and greater trochanter of the femur such that a portion of the neck is preserved; impacting a femoral implant into the femur, the femoral implant including a stem having a porous bone-ingrowth portion and a convex lateral side that is defined by a radius of curvature and a plurality of teeth disposed on a distal portion of the lateral side; and cutting the bone using the plurality of teeth which is performed concurrently with the impacting step. The method may further include the step of planning the implantation using a CT-based 3D plan of a patient. The resecting step may include the use of a burr to resect the femur. The resecting step may be performed robotically. The method may further include creating a pilot hole that includes the use of a curved entry instrument to form the hole. The impacting step may include impacting the implant until the implant forms a press-fit with the resected portion of the femur. The impacting step may include impacting the implant until a flange disposed at the proximal end of the stem is on or within 2 millimeters of the resection level of the femur.
In certain alternative embodiments, a method of implanting a femoral implant may include planning procedure resection location on a femoral neck using a 3D CT scan of a patient; removing a proximal portion of the femoral neck using a robotically controlled high-speed burr so as to leave a distal portion of the femoral neck; preparing a pilot hole that extends into the femoral canal using a curved instrument; and impacting a femoral implant into the pilot hole, wherein the implant includes a plurality of teeth disposed on the distal-lateral surface of the implant to allow for self-broaching. The step of removing a proximal portion of the femoral neck may include robotically tracking the removal of the bone to ensure the bone removal accords with the surgical plan.
The present disclosure will now be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all aspects of the disclosure are shown. Indeed, the disclosure may be embodied in many different forms and should not be construed as being limited to the aspects set forth herein. Like numbers refer to like elements throughout.
As used herein, the term “proximal,” when used in connection with a device or components of a device, refers to the end of the device closer to the surgeon or user when the device is being used and implanted as intended. On the other hand, the term “distal,” when used in connection with a device or components of a device, refers to the end of the device farther away from the surgeon or user when the device is being used and implanted as intended. As used herein, the terms “substantially,” “generally,” “approximately,” and “about” are intended to mean that slight deviations from absolute are included within the scope of the term so modified.
At proximal end 102, implant 100 includes a head receiving portion 110, which is configured to receive a modular prosthetic spherical head (see
A stem 130 is coupled to and extends distally from the distal end of neck 120. Stem 130 includes a proximal stem portion 134 and a distal stem portion 136. The proximal end of stem 130 includes a flange 125 where stem is coupled to neck 120. Flange 125 is generally stadium-shaped, i.e., flange 125 generally forms a rectangle with rounded corners. It is contemplated that the flange may define any shape that is suitable to prevent subsidence and does not substantially overhang the neck, such as an oval, rectangle, or the like. Flange 125 has a length and width which are each greater than the second diameter of neck 120, forming a peripheral shoulder at the connection between neck 120 and stem 130. When implant 100 is fully implanted, flange 125 sits at the neck resection level to provide initial stability and prevent subsidence of the stem after final seating. Stem 130 has a medial side 106 which, when the prosthesis is implanted as intended, will face toward a medial extent of the femur and the middle of the patient's body. Stem 130 further has a lateral side 108 which, when the prosthesis is implanted as intended, will face toward a lateral extent of the femur and the outside of the patient's body. Stem 130 further has an anterior side 107 which will face the front of the patient's body, and a posterior side 109 which will face the rear of a patient's body. It should be noted that the anterior and posterior sides are not limited to facing in their respective directions as defined above, but are merely defined this way for ease of illustration. Implant 100 may be implanted into a first femur on one side of the patient with the anterior side facing frontward and the posterior side facing rearward. However, implant 100 may be implanted into a second femur on the opposing side of the patient with the anterior side facing rearward and the posterior side facing frontward.
As stem 130 extends distally, stem 130 curves toward medial side 106. Thus, medial side 106 has a concave curvature which may transfer load to the proximal femoral neck and medial calcar region and may improve the press fit between stem 130 and the femoral neck. Lateral side 108 has a convex curvature, which may conserve bone at the femoral neck, improve press fit, and improve stem insertion by clearing the lateral cortices within the femoral shaft. As illustrated in
Proximal stem portion 134 may have a cross-sectional shape that is generally quadrilateral, such that the taper of proximal stem portion 134 clears all of the cortices of the femoral neck upon insertion except the general medial calcar region, which is approximately where proximal stem portion 134 is seated after insertion. As proximal stem portion 134 extends distally, the length and width of stem portion 134 taper, wherein the length is defined by the distance between medial side 106 and lateral side 108 and the width is defined by the distance between anterior side 107 and the posterior side 109. The anterior-posterior taper is illustrated more clearly in
It is also contemplated that the entire stem 130 may taper in length and width. Proximal stem portion 134 includes a 3D porous coating to enable bone ingrowth and long-term fixation of implant 100 within the femur. A boundary between the porous coating and non-porous stem extends medially-laterally at an oblique angle relative to an axis of the stem such that the boundary is more proximal on the lateral side than on the medial side. Thus, the porous coating extends along a longer length on the medial side than on the lateral side. In this regard, the lateral side provides a longer smoother surface in order to provide clearance to enable the stem to fully seat within the canal, whereas the medial side provides greater fixation due to the additional porous surface area. The porous coating may be made from titanium or any biocompatible material such as hydroxyapatite or the like. Distal stem portion 136 is polished to avoid bony in-growth at the distal end of implant 100 and reduce stress shielding. Referring back to
As illustrated in
As shown in
It is contemplated that the pre-surgical plan of the patient may use any means of imaging, such as X-Ray, MRI, or the like, and the plan may also include 3D modeling of the implant and/or the femur of the patient through the use of CAD or similar software. It is also contemplated that any appropriate cutting means may be used to resect the femur, such as a reciprocating saw or the like. In some examples, the resection of the femur may be performed manually by a surgeon rather than robotically. It is contemplated that not all of the steps as described above are required for implantation. For example, a pilot hole may not be formed prior to implantation, but rather the implant may be impacted into the femur after the step of resecting.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
This application claims the benefit of the filing date of U.S. Provisional Application No. 63/092,547 filed Oct. 16, 2020, the disclosure of which is hereby incorporated by reference herein in its entirety.
Number | Date | Country | |
---|---|---|---|
63092547 | Oct 2020 | US |