The present invention relates to an ankle prosthesis implant, and is more specifically directed to a talar implant, mating bearing component, and tibial implant.
Ankle prosthetic implants are well known. Some known existing implants are disclosed by U.S. Pat. Nos. 8,715,362 and 9,925,054; and US Pub. 2014/0107799. One specific design for ankle prosthetic implants includes a talar implant component that defines a saddle shaped bearing surface.
Known talar implants suffer from limitations regarding articulation. In particular, there is a need for a talar implant that provides improved flexion and extension of the ankle joint, as well as the requisite internal and external rotation. Existing implants only allow for limited flexion and extension (i.e. hinging motion).
It would be desirable to provide an ankle prosthetic device that both allows a patient to move their repaired ankle within the desired range of motion, and specifically provides a wide range of axial rotation and planar rotation.
An ankle prosthesis implant is disclosed herein. The ankle prosthesis implant includes a talar implant defining a superior bearing surface. The superior bearing surface includes a convex portion or curvature and a concave portion or curvature. The convex portion is defined in an anterior-posterior direction when viewed from a sagittal plane and has a neutral axis (X1) defined in a coronal plane approximately at the anterior-posterior midline of the talar implant and extending in a medial-lateral direction. The term approximately, as used in this context, means in the middle 50% (+/−5%) of the anterior-posterior length of the talar implant. The concave portion is defined in the medial-lateral direction when viewed from the coronal plane, and the concave portion is swept about a secondary axis (X2) that is angled relative to the neutral axis (X1) upwards in the medial-lateral direction towards a medial end of the talar implant by an angle (θ).
In one embodiment, the angle (θ) of the secondary axis (X2) relative to the neutral axis (X1) is between 1° to 30°. In another embodiment, the angle (θ) of the secondary axis (X2) relative to the neutral axis (X1) is tilted upwards by 5° to 10° toward the medial end of the talar implant. The angle (θ) of the secondary axis (X2) relative to the neutral axis (X1) can also be tilted upwards 7° toward the medial end of the talar implant. In another embodiment, the angle (θ) of the secondary axis (X2) relative to the neutral axis (X1) is tilted upwards by at least 5° toward the medial end of the talar implant.
In one embodiment, the concave portion has a single radius of curvature when viewed from the coronal plane. In other embodiments, the concave portion has multiple radii of curvature when viewed from the coronal plane.
The geometry of the talar implant is selected to provide maximum bone coverage and appropriate range of motion. The width (WS) of the concave portion in the medial-lateral direction when viewed from an axial plane is preferably less than an overall width (WO) of the talar implant in the medial-lateral direction when viewed from the axial plane.
Siderails can be provided at a lateral end and a medial end of the concave portion, and the siderails each partially define an outermost medial edge and an outermost lateral edge of the talar implant. The siderails are angled by a siderail angle (β) from a vertical plane (P) extending in a superior-inferior direction when viewed from the coronal plane. In one embodiment, the siderail angle (β) is between −30° to 60°. The siderails preferably each have a siderail height (HSR) in a superior-inferior direction when viewed in the coronal plane that is at least 0.5 mm. In another embodiment, the siderail height (HSR) is at least 1%-15% of a total height (HT) of the talar implant in the superior-anterior direction when viewed in the coronal plane.
The contour of the convex portion can include varying degrees of curvature. In one embodiment, the convex portion has a single radius of curvature when viewed from the sagittal plane. In another embodiment, the convex portion has multiple radii of curvature. In another embodiment, the convex portion has a region at its anterior end where the convex curvature transitions to a concave curvature
The talar implant defines an inferior bone contacting region that includes at least one bone attachment protrusion. The at least one bone attachment protrusion is dimensioned to extend inside of a bone.
The ankle prosthesis implant also includes a bearing component defining a mating surface that abuts the superior bearing surface and articulates with the talar implant. The mating surface of the bearing component includes a concave bearing surface when viewed in the sagittal plane and a convex bearing surface when viewed in the coronal plane. In one embodiment the bearing surface has a width in the medial-lateral direction that is less than the width of the talar component in the medial-lateral direction.
The ankle prosthesis implant also includes a tibial implant. The tibial implant includes at least one dorsal fin that extends in the medial-lateral direction and extends perpendicular from a superior planar surface of the tibial implant. The at least one dorsal fin includes at least one of a void, opening, or hole, which promotes attachment with a patient's bone.
The ankle prosthesis implant disclosed herein generally provides axial rotation with flexion and extension of the ankle joint, as well as planar rotation, i.e. when the ankle is pointed downward.
The ankle prosthesis implant also allows for the overall axis of rotation to move, such that movement is not constrained to a single cylindrical plane.
Additional embodiments are disclosed herein.
The foregoing Summary and the following Detailed Description will be better understood when read in conjunction with the appended drawings, which illustrate a preferred embodiment of the invention. In the drawings:
Certain terminology is used in the following description for convenience only and is not limiting. The words “front,” “upper” and “lower” designate directions in the drawings to which reference is made. A reference to a list of items that are cited as “at least one of a, b, or c” (where a, b, and c represent the items being listed) means any single one of the items a, b, or c, or combinations thereof.
The coronal, sagittal, and axial planes are illustrated throughout the drawings and referenced throughout this disclosure. These directional terms are used according to their generally accepted definitions as used in the medical field unless explicitly clarified herein. The terms superior/inferior, medial/lateral, and posterior/anterior are similarly used according to the generally accepted definitions as used in the medical field, unless explicitly clarified herein. The drawings include further clarifications regarding these directions and planes to the extent it is believed necessary. The terms top/bottom are sometimes used interchangeably with superior/inferior, and the term side is sometimes used interchangeably with medial/lateral.
As shown in
The talar implant 100 defines an inferior bone contacting region 101 (shown in
The superior bearing surface 102 includes a convex portion or curvature 104 and a concave portion or curvature 106. The convex portion 104 and the concave portion 106 are both defined in various regions of the bearing surface 102, depending on which direction and through which plane that the bearing surface 102 is viewed from.
In one aspect, the superior bearing surface 102 has a hyperbolic paraboloid profile, and more specifically has a truncated hyperbolic paraboloid profile. The surface 102 is formed as doubly ruled surface. In other words, the profile includes two sets of mutually skewed lines to form the surface 102, and forms a “saddle surface.” More details of the surface 102 are provided herein.
The convex portion 104 is defined in an anterior-posterior direction when viewed from the sagittal plane and has a neutral axis (X1) defined in the coronal plane at approximately the anterior-posterior midline of the talar implant and extending in the medial-lateral direction. As explained above, the term approximately means the middle 50% (+/−5%) of the anterior-posterior length of the talar implant. The positioning of the neutral axis (X1) is best shown in
In one embodiment, the convex portion 104 can consist entirely of a single convex profile in any given sagittal plane. The convex portion 104 is illustrated with a single radius of curvature (Z) when viewed from the sagittal plane, as shown in
As shown in
The concave portion 106 is defined in the medial-lateral direction when viewed from the coronal plane. The concave portion 106 is swept about a secondary axis (X2) that is angled relative to the neutral axis (X1) in the medial-lateral direction by an angle (θ). In other words, the secondary axis (X2) is angled relative to the sagittal plane and the axial plane, and the angle of the secondary axis (X2) effectively sweeps the concave portion 106 to form a saddle profile for the superior bearing surface 102. The secondary axis (X2) is the primary axis upon which the bearing component can articulate about the talar component. The concave portion 106 is formed by rotating the concave portion 106 about the secondary axis (X2). One of ordinary skill in the art would understand that the concave portion 106 could be formed in a variety of ways, e.g. 3-D printing. When the bearing component 200 articulates on the talar implant 100 it follows the secondary axis (X2). However, because the bearing component 200 is free to slide in the medial and lateral directions, there is not a single axis of rotation of the bearing component 200 relative to the talar implant 100.
As shown in
This angle (θ) provides a sweeping profile of the concave portion 106, and allows for internal rotation of the talar implant 100 with plantar flexion. The specific values of the angle (θ) were selected as providing improved range of motion. Specifically, this angle (θ) gives coupled plantar flexion with internal rotation of the talar implant 100 and dorsal flexion with external rotation of the talar implant 100. This range of motion in multiple directions is critical for walking and mobility in a patient after the ankle prosthesis implant 1 is implanted.
The ankle prosthesis implant 1 provides independent inversion and eversion through the range of motion, as well as in the dorsiflexed, plantarflexed, and neutral foot. This is a result of the concave saddle shape of the talar implant being continuous from the medial to lateral direction. Existing implants prevent medial-lateral motion. The embodiments disclosed herein prevent the medial and lateral motion at the edges via the siderails, or simply as a result of the concavity. The ankle prosthesis implant 1 provides the approximate flexion angle range when heel striking occurs during a person's gait, as well as absorption of a person's foot impacting the ground during a wide range of required motion, such as smaller steps or shuffling, pivoting, uneven terrain environments, etc.
The saddle shape of the talar implant 100 generally provides a specific amount independent range of motion, for inversion and eversion, that is not coupled with flexion-extension or internal-external rotation. The saddle shape of the talar implant 100 reduces the forces and stresses on both the bone-implant interface and stabilizing soft tissues, by providing an extra degree of freedom.
Additional features of the concave portion 106 are described herein. In one embodiment, as shown in
In other embodiments, such as shown in
The width of the bearing component 200 is less than the width of the talar implant 100. This allows distinct inversion-eversion motion of the bearing component 200 relative to the talar implant 100, while still maintaining substantial contact between the articulating surfaces. In other words, the bearing component 200 can rotate or translate up the side surfaces formed by the saddle profile of the talar implant 100. The length (L) of the talar implant influences flexion-extension range of motion, but not varus-valgus. Varus-valgus (also described as inversion-eversion) is dictated by the width (WS) of the talar implant, the width of the articulating surface of the bearing component, and the radii of curvature of the concave surface on the talar implant.
In one embodiment, the width (WS) of the concave portion 106 in the medial-lateral direction when viewed from an axial plane is less than an overall width (WO) of the talar implant 100 in the medial-lateral direction when viewed from the axial plane. The overall width (WO) of the talar implant 100 is defined between an outermost medial edge 105a and an outermost lateral edge 105b. In one embodiment, the width (WS) is between 80%-99% of the overall width (WO).
As shown in
One of ordinary skill in the art would understand that the respective surfaces on the talar implant 100 and the bearing component 200 may not include tapered profiles.
As best shown in
As shown in
In one embodiment the siderails are omitted and do not exist. The amount of constraint, or limitation on the range of motion or translation in the medial lateral direction is a function of the siderail in addition to the concave surface. The addition of a siderail provides additional constraint to the implant construct limiting excessive motion that may be present when normal range of motion is exceeded (i.e. walking on uneven ground, spraining or “rolling the ankle”, etc.).
In one embodiment, as shown in
Although not explicitly annotated, the angle of the sidewall taper can also be the same in the other embodiments.
The bearing component 200 articulates with at least the talar implant 100 and also possibly with the tibial implant 300. The bearing component 200 defines a mating surface 201 that abuts the superior bearing surface 102 and articulates with the talar implant 100. As shown in
Referring to
In another embodiment, outer portions of the convex bearing surface 202 of the bearing component 200 (i.e. end surfaces 201a, 201c) are offset from the concave portion 106 of the talar implant 100 in a variable manner. In other words, the end surfaces 201a, 201c are not complementary or congruent to the concave portion 106 of the talar implant 100. The offset portions 201a, 201c are illustrated as outer sections of the convex bearing surface 202.
The bearing component 200 further includes a bearing lock surface 204, and support regions 206a, 206b that are adapted and dimensioned to interface with the tibial implant 300. The combination of the bearing lock surface 204 and support regions 206a, 206b allows the bearing component 200 to be slid into engagement with correspondingly shaped regions of the tibial implant 300, which are described in more detail herein. In another embodiment, the bearing component is designed to articulate with the tibial component and does not include a lock surface or additional support regions.
The tibial implant 300 is more clearly shown in
The at least one dorsal fin 302a, 302b further includes at least one of a void, opening, or hole 303. Although three voids, openings, or holes 303 are illustrated in the drawings, one of ordinary skill in the art would understand based on the present disclosure that any number of voids, openings, or holes 303 can be provided. These voids, openings, or holes 303 are generally provided to promote adhesion or attachment of the tibial implant 300 with a patient's bone.
The tibial implant 300 further includes a channel 304 defined on a lower or inferior surface. The channel 304 is defined by at least two siderails 306a, 306b that are dimensioned to receive a portion of the bearing component 200. The channel 304 is dimensioned to receive a portion of the bearing component 200, and more specifically receives the support regions 206a, 206b of the bearing component 200. A lock slot 308 is defined on the inferior surface of the tibial implant 300 and is dimensioned to receive the bearing lock surface 204. Although specific shapes, sizes, and geometries are illustrated for the mating features of the bearing component 200 (i.e. the bearing lock surface, support regions 206a, 206b, etc.) and the tibial implant 300 (i.e. the channel 304, siderails 306a, 306b, lock slot 308, etc.), one of ordinary skill in the art would understand based on the present disclosure that these components may be modified. Each of these corresponding features on the bearing component 200 and the tibial implant 300 are generally shaped to be complementary to each other.
Although a single talar implant 100 is shown and described herein, one of ordinary skill in the art would understand from this disclosure that a similar talar implant 100 would be provided for a patient's opposite ankle. The talar implant for an opposite ankle would include identical features, but oriented to conform to the patient's opposite ankle. One of ordinary skill in the art would also recognize from this disclosure that the size of the talar implant can vary, depending on the size of the patient in which the talar implant is being used.
Additionally, the talar implant 100 can be used independently of any tibial implant 300.
The embodiments disclosed herein generally provide flexion and extension of the ankle joint (when viewed in the sagittal plane), along with internal/external rotation (i.e. rotation about a vertical axis of a patient's foot) that is coupled with the flexion/extension and along with independent inversion and eversion. The embodiments disclosed herein generally provide at least 3° of total rotation coupled with flexion and 3° of rotation coupled with extension.
Having thus described the present invention in detail, it is to be appreciated and will be apparent to those skilled in the art that many physical changes, only a few of which are exemplified in the detailed description of the invention, could be made without altering the inventive concepts and principles embodied therein.
It is also to be appreciated that numerous embodiments incorporating only part of the preferred embodiment are possible which do not alter, with respect to those parts, the inventive concepts and principles embodied therein.
The present embodiment and optional configurations are therefore to be considered in all respects as exemplary and/or illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all alternate embodiments and changes to this embodiment which come within the meaning and range of equivalency of said claims are therefore to be embraced therein.
The following document is incorporated by reference as if fully set forth herein: U.S. Provisional Patent Application 62/901,068, filed Sep. 16, 2019.
Number | Date | Country | |
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62901068 | Sep 2019 | US |