Patent Grant
12303396
All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
Problems of the patella-femoral joint are a common cause of knee pain. The pain may arise from issues such as poor alignment of the patella or from cartilage breakdown (chondromalacia or arthritis) behind the patella or on the opposing articular surface of the femoral groove (trochlea). Conventional surgical options for treating patella-femoral pain caused by malalignment, chondromalacia or arthritis may include realignment of the patella. For example tracking of the patella may be changed by tilting the patella or by moving the patella to one side or the other. Moving the patella forward (i.e., anteriorly) through a surgical procedure provides another conventional option for treating these conditions. This conventional technique is thought to decrease force across the patella-femoral joint and thus diminish the pain arising from excess force against a worn-out patellar or trochlear cartilage.
Although available, surgical options to realign the patella may be very invasive. For example, surgeries may involve cutting and fixating the bony attachment of the patellar tendon. In particular, conventional techniques may include detaching the patellar tendon from the tibia, then reattaching the patellar tendon at a new location to obtain the desired alignment of the patella. Such invasive surgical techniques may also result in prolonged recovery times. Consequently, an improved mechanism for treating patella-femoral joint problems such as patella-femoral pain, chondromalacia, and/or arthritis is desired.
U.S. Pat. No. 9,808,289 discloses embodiments of a patellar tendon realignment implant configured to be placed between the patellar tendon and the tibia in proximity to the patella to elevate and/or tilt the patellar tendon. Each of the implants has a fixed height and cannot be adjusted prior to, or after, implantation to meet the patient's needs.
Some activities result in higher tension or compression of the patellar tendon. For example, stair climbing and jumping increase the tension on the patellar tendon, and kneeling or sudden impacts to the knee increase patellar tendon compression. It may be desirable to temporarily change the shape of a patellar tendon realignment implant during application of a tension load on the patellar tendon (e.g., during stair climbing, jumping, etc.) or application of a compression load on the patellar tendon (e.g., during kneeling, a sudden impact to the knee, etc.).
One aspect of the invention provides an orthopedic implant with an inferior portion having a tibia contact surface configured to extend over a tibia; a superior portion opposite to the inferior portion having a tendon contact surface configured to change a position of a patellar tendon by lifting or tilting the patellar tendon when the curved surface of the first portion is engaged with the tibia; a fixation mechanism adapted to attach the orthopedic implant to the tibia; and an adjustment mechanism adapted to change a distance between the tendon contact surface and the tibia contact surface.
In some embodiments, the orthopedic implant also has a hinge or pivot connecting the superior portion to the inferior portion.
In some embodiments, the adjustment mechanism includes a piston disposed between the superior portion and the inferior portion. In some such embodiments, the adjustment mechanism includes a port fluidly connected with an interior of the piston through which fluid can be added or removed from the interior of the piston. In other such embodiments, the piston has a threaded connection between a superior piston element and an inferior piston element.
In some embodiments, the adjustment mechanism includes a rotatable cam disposed between the superior portion and the inferior portion.
In some embodiments, the adjustment mechanism includes an adjustable connection between the superior portion and the inferior portion adapted and configured to enable a user to move the superior portion along a ramp to change the distance between the tendon contact surface and the tibia contact surface. In some such embodiments, the adjustment mechanism includes a sliding connection between the ramp and the superior portion, wherein moving the superior portion along the sliding connection changes the distance between the tendon contact surface and the tibia contact surface. In some or all such embodiments, the adjustment mechanism also has a lock with a first configuration adapted to hold a position of the superior portion with respect to the inferior portion and a second configuration adapted to permit the superior portion to be moved with respect to the inferior portion.
In some embodiments, the adjustment mechanism comprises a column fixed to, and extending up from, the inferior portion, and a plurality of connection slots to which the superior portion can be selectively engaged. In some such embodiments, the adjustment mechanism also has a tab supported by the superior portion and biased by a spring, the spring biasing the tab into one of the connection slots to prevent relative movement between the superior portion and the inferior portion, the tab being movable against the spring out of the one of the connection slots to permit movement of the superior portion with respect to the inferior portion. The orthopedic implant may also have a button operatively connected to the tab to move the tab against the spring. In other such embodiments, the adjustment mechanism further has a rotatable connection between the superior portion and the column, the rotatable connection having a first position permitting movement of the superior portion to a second connection position and a second position preventing movement of the superior portion from the first connection position to the second connection position.
In some embodiments, the orthopedic implant has a sealed cavity disposed between the superior portion and the inferior portion, the adjustment mechanism comprising a port in fluid communication with the sealed cavity.
Another aspect of the invention provides a method for repositioning a patellar tendon of a patient. In some embodiments, the method includes the steps of inserting an orthopedic implant in a first configuration between the patellar tendon and a tibia; engaging a tibia contact surface of an inferior portion of the orthopedic implant with the tibia; engaging a tendon contact surface of a superior portion of the orthopedic implant with the patellar tendon; changing a distance between the tendon contact surface and the tibia contact surface; and changing a position of the patellar tendon
In some embodiments, the step of changing a distance between the tendon contact surface and the tibia contact surface is performed after the steps of engaging the tibia contact surface with the tibia and engaging the tendon contact surface with the patellar tendon. In some such embodiments, the changing step includes the step of inserting a tool through a skin opening to engage an adjustment mechanism. Such methods may also include the step of piercing the skin with the tool.
In some embodiments, the step of changing a distance between the tendon contact surface and the tibia contact surface includes the step of moving the superior portion along a ramp.
In some embodiments in which a first end of the superior portion is connected to the inferior portion with a hinge or pivot, the step of changing a distance between the tendon contact surface and the tibia contact surface includes the step of moving a second end of the superior portion about the hinge or pivot.
In some embodiments, the step of changing a distance between the tendon contact surface and the tibia contact surface comprises changing a height of a piston extending between the superior portion and the inferior portion, such as by changing the height of the piston comprises adding or removing fluid from an interior of the piston or rotating a ring engaged with threads on the piston.
In some embodiments, the step of changing a distance between the tendon contact surface and the tibia contact surface includes the step of changing a position of a cam disposed between the superior portion and the inferior portion.
In embodiments in which the orthopedic implant has a column disposed between the inferior portion and the superior portion, the step of changing a distance between the tendon contact surface and the tibia contact surface may include the step of disengaging a tab from a slot in the column. In some such embodiments, the step of disengaging a tab from a slot in the column includes the step of moving the tab against a spring, and the step of changing a distance between the tendon contact surface and the tibia contact surface includes the step of permitting the spring to move the tab back into a slot of the column. In other such embodiments, the step of disengaging a tab from a slot in the column includes the step of rotating the superior portion with respect to the inferior portion.
In embodiments in which the orthopedic implant has an expandable cavity disposed between the tendon contact surface and the tibia contact surface, the step of changing a distance between the tendon contact surface and the tibia contact surface may include the step of adding or removing fluid from the expandable cavity.
In some embodiments, the step of changing a distance between the tendon contact surface and the tibia contact surface is performed before the steps of engaging the tibia contact surface with the tibia and engaging the tendon contact surface with the patellar tendon.
Some embodiments include the further step of locking the orthopedic implant after changing the distance between the tendon contact surface and the tibia contact surface.
The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:
The superior portion 20 of the implant has a tendon contact surface 22 on its top side. Two side portions 28 and 29 extend between the inferior portion and the superior portion. In this embodiment, the anterior end 24 of the implant 10 is taller than the posterior end 26 of the implant. When in place on the patient, the anterior end 24 is placed closer to the patient's patella 27 than the posterior end 26 is, as shown in
Superior portion 20 may be extended or retracted along a ramp 32 extending between the side portions 28 and 29 to change the distance between the tibia contact surface and the tendon contact surface by changing the effective height of the anterior end of the implant in order to provide the desired upward lift of the patellar tendon. A pin 11 extending from superior portion 20 through a slot 15 in the ramp 32 limits the motion of superior portion 20 along the ramp 32. Thereafter, locks 34 (such as, e.g., a movable screw) may be engaged to prevent further movement. The implant's effective height may be set prior to implantation, or, as shown in
The orthopedic implant 40 of
The orthopedic implant 80 shown in
The orthopedic implant 120 shown in
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This application claims the benefit of priority of U.S. Provisional Application No. 63/022,977, filed May 11, 2020, herein incorporated by reference in its entirety.
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