The present disclosure relates generally to implantable devices and methods for hip replacement surgery.
Joints such as hip joints can become damaged. This damage can be caused by a variety of factors including age, injury, etc. It can also result in pain and limited mobility. Various medical devices and methods have been developed to treat damaged hip joints, including totally or partially replacing the hip joint with prostheses. However, these devices and methods have their shortcomings. As such, there is a need for improved devices and methods for hip replacement procedures.
The present disclosure is directed toward methods and apparatuses relating to hip replacement surgery, specifically relating to devices, assemblies, and methods for stabilizing a femoral hip stem.
Certain embodiments of the disclosure concern a hip prosthesis having a femoral component that includes a stem member configured to extend into a femur of a patient. The stem member includes a channel having a first opening and a second opening that is distal to the first opening. The channel has a longitudinal axis that intersects a longitudinal axis of the stem member.
Certain embodiments of the disclosure also concern an assembly including a femoral component and a locking member. The femoral component includes a stem member configured to extend into a femur of a patient. The locking member is configured to extend through the femoral component to affix the stem member to the femur.
Certain embodiments of the disclosure further concern a method for implanting a hip prosthesis. The method includes inserting a stem member of a femoral component into a femur of a patient and inserting a locking member through a channel of the stem member. The locking member is longer than the channel such that a tip portion of the locking member penetrates the femur.
The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
For purposes of this description, certain aspects, advantages, and novel features of the embodiments of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed embodiments require that any one or more specific advantages be present or problems be solved.
Typical devices and methods for hip replacement procedures have their shortcomings. As such, there is a need for improved devices and methods these procedures. Such devices and methods are disclosed herein.
In total hip replacement, the damaged bone and cartilage are removed and replaced with prosthetic components. Specifically, the articular surfaces of the normal hip joint are replaced with new bearings which are fixed to the bone. These bearings form a ball-and-socket joint and are fixed to the corresponding bones, the hipbone and the femur, using different geometries. For the cup, the implant typically has a spherical type geometry which can mate with a spherically reamed bone. For the femoral component, the implant can have an extended stem for fixation within the canal of the femur following broaching the canal. Fixation of the implants can also be different with some implants being cemented into the bone while others are press fit with porous surfaces for long-term fixation through bone ingrowth.
With press fit applications, the bone must be strong enough to support the implant. Support is primarily afforded by trabecular bone (spongy bone) and secondarily by cortical bone (hard, compact bone). During the first few weeks following the press fit surgery, the bone must keep the implant stable with minimal motion providing the opportunity for the bone to grow into the porous structure of the implants. As the quality of the bone reaches a minimum strength, surgeons make the decision to cement the implant instead of press fitting. However, between the good strength bone and the insufficient strength bone lies a questionable zone of bone quality which may or may not be able to support a press fit application. In those patients, if the preference is to press fit, the stability of the femoral implant may be questionable.
The loading of the acetabular implant is primarily in compression and offers the option for press fitting most of the time. However, the stem of the femoral implant is pressed into a bed of trabecular bone within the femoral canal and in some cases, that bone may not be able to resist torsional, compressive and shear loads. Complications from this inadequacy include subsidence of the stem (i.e., it moves further into the femoral canal) and/or torsional movement of the stem (i.e., it rotates within the canal). In either case, this type of gross motion can lead to poor biomechanics leading to instability and subluxation (the head comes out of the acetabular implant) requiring revision surgery. It can also lead to a fibrous tissue ingrowth, rather than bone ingrowth, into the implant. Thus, it will not provide sufficient long-term stability for the implant. Accordingly, such complications can result in revision surgery, delayed fixation of the implants, delayed return to normal activities, infection and compromised return to normal function.
Thus, it is desirable to improve the design of the femoral implant to allow the surgeon to stabilize the stem of the femoral implant in those cases where there are questions about the strength of the femoral bone.
In a hip replacement procedures (also known as hip arthroplasty), the damaged bone and cartilage are removed and replaced with one or more prosthetic components. As illustrated in
As shown in
The femoral component 30 can be formed of various biocompatible materials. In some embodiments, the femoral component 30 can be formed of titanium alloys, such as ASTM F-136 (Ti6Al4V ELI Titanium Alloy). In other embodiments, the femoral component 30 can be formed using other biocompatible materials, such as cobalt chromium, stainless steel, and/or various composite materials or polymers.
The stem member 40 can have a proximal portion 44 and a distal portion 46. The stem member 40 can have a generally tapered shape such that the distal portion 46 has a smaller cross-sectional area than the proximal portion 44.
In some embodiments, the neck member 70 and the stem member 40 can be integrally formed from a single piece of material. In some embodiments, the neck member 70 and the stem member 40 can be made of different materials but are fixedly coupled together to form a unitary piece (e.g., by welding, adhesive, etc.). In other embodiments, the neck member 70 and the stem member 40 can be detachably coupled to each other, such as with fasteners.
The proximal portion 44 can have a porous region 48 configured to promote bone ingrowth, creating mechanical interlocking between the femur 10 and the stem member 40. Such bone ingrowth can improve the long term stability of the femoral component 30 by reducing stress concentrations and bone resorption, as well as improving the torsional strength of the femoral component 30 and reducing the likelihood of the need for revision surgery. Various methods of creating porous surface at the porous region 48 can be employed, as disclosed in U.S. Patent Application Publication No. 2014/0067080, which is incorporated herein by reference.
The stem member 40 of the femoral component 30 can be coupled to the femur 10 in various ways. For example, the stem member 40 can be secured in the femoral canal 18 of the femur 10 with an adhesive (e.g., bone cement) and/or a frictional fit (e.g., press fit).
The stem member 40 needs to resist the loads exerted upon it such that the stem member 40 resists motion between the implant and bone. In some instances, even minimal motion (e.g., greater than about 75-100 microns) between the implant and the bone can cause the implant to be ingrown by fibrous tissue rather than bone tissue. That interface with fibrous tissue can, in some cases, lead to aseptic loosening of the implant, which typically requires revision surgery.
For example, as illustrated in
In addition, as shown in
Similar to the femoral component 30 described above, the femoral component 130 comprises a stem member 140 and a neck member 170 extending from a proximal end portion 138 of the stem member 140. The neck member 170 has a longitudinal axis 172 that intersects a longitudinal axis 142 of the stem member 140. The stem member 140 can have a generally tapered shape such that a distal portion 146 of the stem member 140 has a smaller cross-sectional area than a proximal portion 144 of the stem member 140. In addition, the proximal portion 144 can have a porous region 148 that is configured to promote bone ingrowth.
Unlike the femoral component 30, the femoral component 130 further comprises a channel 150 extending through the stem member 140. As described more fully below, a locking member can extend through the channel 150 to affix the stem member 140 to the femur 10 in lieu of or in additional to securing the stem member 140 within the femoral canal 18 by frictional engagement and/or adhesive.
The channel 150 has a body portion 158 extending between a first opening 154 (also referred to as a “proximal opening”) and a second opening 156 (also referred to as a “distal opening”), the second opening 156 being distal to the first opening 154. In the embodiment depicted in
In the depicted embodiments, the longitudinal axis 152 of the channel 150 is configured to intersect the longitudinal axis 172 of the neck member 170. In other embodiments (not shown), the longitudinal axis 152 of the channel 150 can be generally parallel to the longitudinal axis 172 of the neck member 170.
As depicted in
In some embodiments, the distal opening 156 is generally located at the proximal portion 144 of the stem member 140 such that the distal opening 156 can abut an interior bone tissue adjacent to a lateral cortex of the femur 10 when the stem member 140 extends into the femur 10. As shown in
In an alternative embodiment, as shown in
Although it is not shown, it should be understood that the channel 150 can be oriented in other different angles with respect to the longitudinal axis 142 so long as it allows a locking member to extend through and affix the stem member 140 to the femur 10. For example, the proximal opening 154 can be located on the lateral side 136 of the stem member 140 whereas the distal opening 156 can be located on a medial side 134 of the stem member 140.
In some embodiments, as illustrated in
In some embodiments, the proximal opening 154 can be internally threaded. In other embodiments, the proximal opening 154 can have no internal threads. In some embodiments, the body portion 158 of the channel 150 is internally threaded. In some embodiments, the body portion 158 of the channel 150 has no internal threads. Yet in other embodiments, at least one part of the body portion 158 has internal threads and at least another part of the body portion 158 has no internal threads.
The locking member 180 includes a head portion 182, a tip portion 184, and a body portion 186 extending between the head portion 182 and the tip portion 184. Generally, the head portion 182 has a larger diameter than the tip portion 184 and the body portion 186.
In some embodiments, the locking member 180 can have a length ranging from about 8 mm to about 80 mm. In some embodiments, the diameter of the body portion 186 of the locking member 180 can range from about 1.5 mm to about 4.5 mm. In some embodiments, the diameter of the channel 150 is about the same or slightly larger than the diameter of the body portion 186 so as to allow insertion of the locking member 180 into the channel 150.
In an exemplary embodiment, the locking member 180 is longer than the channel 150 inside the stem member 140. Thus, when the locking member 180 is disposed in the channel 150 and the head portion 182 is aligned with the proximal opening 154, the tip portion 184 can protrude beyond the distal opening 156.
In some embodiments, the head portion 182 of the locking member 180 is configured to mate with the proximal opening 154 of the channel 150. For example, when the proximal opening 154 is internally threaded, the head portion 182 can be externally threaded such that the head portion 182 can be threadably coupled to the proximal opening 154. Optionally, a washer (not shown) may be inserted into the first opening 154 before inserting the locking member 180 into the channel 150.
Alternatively, the head portion 182 can mate with the proximal opening 154 by other means. For example, a non-threaded head portion 182 can be detachably coupled to a non-threaded proximal opening 154 by means of interference fit, snap fit, or a tongue-and-groove locking mechanism, etc.
The tip portion 184 can be adapted to penetrate bone of different strength. For example, the tip portion 184 can be configured to have various shapes such as oval, cone, half-tipped, plain cup, flat, etc. The head portion 182 can be configured to be compatible with different screw types such as slotted, Phillips, hex, Torx, etc.
In the embodiment depicted in
In the depicted embodiment, the locking member 180 passes through the posterior (caudal) portion of the great trochanter 14 and the tip portion 184 protrude out of the lateral cortex 16 of the femur 10.
Optionally, a restraining member (not shown), such as a nut or a washer, can be attached to the tip portion 184 to prevent movement of the locking member 180 relative to the femur 10. Other restraining mechanisms, e.g., attaching hinged flaps to the tip portion 184 to form a toggle bolt, can also be employed to securely hold the locking member 180 to the femur 10.
In other embodiments (not shown), the locking member 180 is configured to penetrate the posterior (caudal) portion of the great trochanter 14, but the tip portion 184 does not protrude out of the lateral cortex 16.
Optionally, the locking member 180 can be configured to be expandable after penetrating the femur 10 so as to further secure the locking member 180 in place. In one exemplary embodiment, the body portion 186 of the locking member 180 can include one or more self-expandable barbs or wings, e.g., being made of shape-memory alloy (e.g. Nitinol), that can change from a collapsed configuration and to an expanded configuration after implantation.
In some embodiments, the locking member 180 can have areas that are coated with a porous material that is configured to facilitate bone ingrowth, which can further secure the locking member 180 within the femur 10.
Optionally, after affixing the stem member 140 to the femur 10 with the locking member 180, the proximal opening 154 of the channel 150 can be covered with a cap (not shown) or sealed with a biocompatible material to cover the head portion 182 of the locking member 140.
As illustrated in
In one embodiment, a distal end portion 164 of the guide member 160 can be configured to mate with the proximal opening 154 of the channel 150. For example, the distal end portion 164 of the guide member 160 can be tapered and externally threaded so as to mate with the internal threads of the proximal opening 154. In another example, the distal end portion 164 of the guide member 160 can snap fit into the proximal opening 154.
In other embodiments, the distal end portion 164 of the guide member 160 can be configured to engage with the body portion 158, or even the distal opening 156, of the channel 150. For example, the distal end portion 164 of the guide member 160 can have a smaller diameter than the body portion 158 so that the guide member 160 can be inserted into the body portion 158 channel 150. The proximal end portion 166 of the guide member 160 can have a larger diameter than the body portion 158 so that the proximal end portion 166 can remain outside the channel 150 for receiving the drill member 168.
After inserting the drill member 168 into the channel 150 through the guide member 160, a hand drill can be employed to drive the drill member 168 into the femur 10. Thus, a hole 26 can be created (pre-drilled) in the femur 10 to facilitate insertion of the locking member 180.
In one exemplary embodiment, the hole 26 has a diameter that is smaller than that of the locking member 180. After removing the drill member 168 and the guide member 160, the locking member 180 can extend through the channel 150 and be screwed into the hole 26, thus affixing the stem member 140 to the femur 10.
In alternative embodiments, the hole 26 can have a diameter that is comparable or slightly larger than that of the locking member 180. For example, an expandable anchor plug (not shown) can be inserted into the hole 26, and then the locking member 180 can be inserted through the anchor plug, thereby expanding the anchor plug to securely anchor the locking member 180 within the hole 26. In another example, the locking member 180 can be expandable. For example, the locking member 180 can be configured as a molly fastener that includes one or more sleeves that can be expanded after being inserted into the hole 26.
In certain embodiments, one or more of the steps shown in process 200 may be combined, and/or performed in different sequences. In certain embodiments, one or more of the steps of the process 200 may be optional. In other embodiments, one or more additional steps can be performed before and/or after one or more the steps of the process 200. For example, instead of using a guide member 160 to guide the insertion of the drill member 168, in certain embodiments, the drill member 168 can be inserted directly into the channel 150 for drilling the hole 26. In another example, the step of predrilling the hole 26 may be omitted. Instead, the locking member 180 can be directly drilled into the femur 10 for affixing the stem member 140 to the femur 10.
It should be understood that the disclosed embodiments can be adapted to deliver and implant prosthetic devices in orthopedic surgical procedures other than hip arthroplasty, such as shoulder arthroplasty, knee arthroplasty, elbow arthroplasty, ankle arthroplasty, etc.
Although the inventive subject matter disclosed herein is described in the context of implanting a hip prosthesis in a patient, it should be understood that the same general principles and various embodiments disclosed above can be adapted to deliver and implant the hip prosthesis in non-human animals, such as canine, swine, bovine, equine, etc.
As used herein, with reference to the stem member and the neck member, “proximal” refers to a position, direction, or portion of a device that is closer to an acetabulum of a pelvis, while “distal” refers to a position, direction, or portion of a device that is further away from the acetabulum. The terms “longitudinal” and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.
As used herein, the term “porous” means a structure having one or more openings, gaps, or other such surfaces that allow bone to grow into the structure and mechanically interlock with the structure. “Bone ingrowth” refers to the growing of bone tissue into a porous structure in a manner that allows the bone to interlock with the structure.
As used herein, the term “smooth” means a structure lacking in openings, gaps, or other such surfaces that would allow bone to grow into the structure.
As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the term “includes” means “comprises.” Further, the terms “coupled” and “connected” generally mean physically, mechanically, chemically, magnetically, and/or electrically linked and do not exclude the presence of intermediate elements between the coupled or connected items absent specific contrary language.
As used herein, the term “approximately” and “about” means the listed value and any value that is within 20% of the listed value. For example, “about 8 mm” means any value between about 6.4 mm and about 9.6 mm, inclusive.
Directions and other relative references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inside,” “outside,”, “top,” “down,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. As used herein, “and/or” means “and” or “or”, as well as “and” and “or”.
Although the operations of some of the disclosed embodiments are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.
In view of the many possible embodiments to which the principles of the disclosure may be applied, it should be recognized that the illustrated embodiments are only examples and should not be taken as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.
This application claims the benefit of U.S. Provisional Application No. 62/632,843, filed Feb. 20, 2018, which is incorporated by reference herein.
Number | Date | Country | |
---|---|---|---|
62632843 | Feb 2018 | US |