US20210338449A1 - Stabilized total ankle prosthesis - Google Patents
Stabilized total ankle prosthesis Download PDFInfo
- Publication number
- US20210338449A1 US20210338449A1 US17/376,242 US202117376242A US2021338449A1 US 20210338449 A1 US20210338449 A1 US 20210338449A1 US 202117376242 A US202117376242 A US 202117376242A US 2021338449 A1 US2021338449 A1 US 2021338449A1
- Authority
- US
- United States
- Prior art keywords
- component
- articulation
- tibial component
- attachment
- articulation surface
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 210000003423 ankle Anatomy 0.000 title claims abstract description 64
- 239000000463 material Substances 0.000 claims description 25
- 210000002303 tibia Anatomy 0.000 claims description 12
- 210000004233 talus Anatomy 0.000 claims description 11
- 238000006073 displacement reaction Methods 0.000 claims description 6
- 210000004872 soft tissue Anatomy 0.000 abstract description 24
- 230000033001 locomotion Effects 0.000 abstract description 21
- 230000001010 compromised effect Effects 0.000 abstract description 19
- 230000000087 stabilizing effect Effects 0.000 abstract 1
- 210000000544 articulatio talocruralis Anatomy 0.000 description 11
- 239000007943 implant Substances 0.000 description 11
- 210000003041 ligament Anatomy 0.000 description 11
- 238000002513 implantation Methods 0.000 description 8
- 210000003484 anatomy Anatomy 0.000 description 4
- 208000037873 arthrodesis Diseases 0.000 description 4
- 241001227561 Valgus Species 0.000 description 3
- 241000469816 Varus Species 0.000 description 3
- 201000008482 osteoarthritis Diseases 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 230000004927 fusion Effects 0.000 description 2
- 238000003780 insertion Methods 0.000 description 2
- 230000037431 insertion Effects 0.000 description 2
- 210000001503 joint Anatomy 0.000 description 2
- 238000010883 osseointegration Methods 0.000 description 2
- -1 polyethylene Polymers 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 230000006641 stabilisation Effects 0.000 description 2
- 238000011105 stabilization Methods 0.000 description 2
- 208000031638 Body Weight Diseases 0.000 description 1
- 208000010392 Bone Fractures Diseases 0.000 description 1
- 238000002266 amputation Methods 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 230000002917 arthritic effect Effects 0.000 description 1
- 206010003246 arthritis Diseases 0.000 description 1
- 230000037396 body weight Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 229910010293 ceramic material Inorganic materials 0.000 description 1
- 210000004439 collateral ligament Anatomy 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 230000003278 mimic effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 210000000963 osteoblast Anatomy 0.000 description 1
- 229940124583 pain medication Drugs 0.000 description 1
- 238000000554 physical therapy Methods 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 239000011148 porous material Substances 0.000 description 1
- 238000002271 resection Methods 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- 210000005065 subchondral bone plate Anatomy 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
- A61F2/4202—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for ankles
- A61F2002/4207—Talar components
Definitions
- An ankle joint may become severely damaged and painful due to arthritis from prior ankle surgery, bone fracture, infection, osteoarthritis, posttraumatic osteoarthritis or rheumatoid arthritis, for example.
- Options for treating the injured ankle have included anti-inflammatory and pain medications, braces, physical therapy, amputation, joint arthrodesis, and total ankle replacement.
- arthrodesis In the past the main-stay of ankle arthrosis has been joint arthrodesis, due to the poor prosthetic survival rate of total ankle replacements. This is primarily due to the clinical results of early ankle designs. Therefore, arthrodesis has been the only choice for many surgeons and patients. Arthrodesis improves stability and reduces pain, but also severely inhibits normal function of the ankle joint. Although some patients have very good results from ankle fusion, surrounding joints above and below the fusion may become arthritic and painful because the lack of ambulation places additional stress on these joints.
- the Agility ankle is an example of an early implant design. It is comprised of two components—one part is cemented to the tibia and the other part is cemented to the talus.
- An issue with the design of the early ankle prostheses is that although they allow for some dorsiflexion/plantarflexion motion, the articulation surfaces restrict varus/valgus and rotation motions.
- Another problem surrounding early implant designs is their reliance on the surrounding soft tissues of the ankle to stabilize the implant. As a result, they are not well suited for implantation in individuals with compromised soft tissues.
- Salto Talaris ankle device which is a fixed-bearing ankle prosthesis.
- This two-component ankle system utilizes a conical talar component with two different radii of curvature and a curved groove in the sagittal plane. The medial radius is smaller than the lateral to allow equal tensioning of the collateral ligaments.
- the tibial component is designed for a fixed insertion of a polyethylene bearing piece that is replaceable.
- STAR Scandinavian Total Ankle Replacement
- the tibial component is designed for less bone resection and has two parallel bars for insertion into the subchondral bone.
- the talar component is meant to mimic the talar dome and has a central ridge for stabilization of a polyethylene piece.
- the STAR prosthesis inhibits inversion/eversion coupling with plantarflexion/dorsiflexion motion. This leads to straining and potential damage to the deltoid ligaments on the medial side of the ankle.
- Another issue with this device is edge loading, which puts a great amount of stress on the ridge of the implant and results in the implant retracting from the talus.
- U.S. Pat. No. 7,625,409 discloses a prosthesis designed to allow full range of motion while minimizing edge loading and subsidence.
- this prosthesis fails to address the need for an implant for use in patients with compromised soft tissues in the ankle.
- FIG. 1 shows an anterior view of an ankle prosthesis according to an embodiment of the present invention
- FIG. 2 shows an anterior view of an ankle joint and surrounding soft tissues
- FIG. 3 shows an anterior view of exemplary means of attachment of an ankle prosthesis according to an embodiment of the present invention
- FIG. 4 shows a posterior view of an ankle prosthesis according to an embodiment of the present invention.
- FIG. 5 shows a medial view of an ankle prosthesis according to an embodiment of the present invention.
- An ankle joint is a very complex joint having three motions that occur simultaneously: dorsiflexion/plantarflexion, varus/valgus, and internal/external rotation.
- the ankle joint relies on soft tissues, including ligaments, to provide stability.
- soft tissues include, for example, an anterior inferior tibiofibular ligament, a calcaneal-fibular ligament, a posterior talo-fibular ligament, a syndesmotic ligament, an anterior capsule of the ankle joint (which helps keep the ankle from anterior movement), and a deltoid ligament.
- These soft tissues contribute to the overall function of the ankle by ensuring joint stability.
- an ankle replacement prosthesis prevents stretching these ligaments beyond their natural range of motion. Further, because the ankle joint absorbs a stress greater than four times the body's weight with every step, an ankle replacement prosthesis ideally will be able to withstand the pressures associated with weight-bearing and motion.
- An ankle prosthesis 1 of the present invention addresses these and additional problems.
- Ankle prosthesis 1 of the present invention provides adequate range of motion for the primary degrees of freedom of the talar joint, including movement in a frontal plane and a sagittal plane. Additionally, ankle prosthesis 1 of the present invention provides stability for implantation into an ankle joint with compromised soft tissues by constraining movement in the general direction of compromised soft tissues.
- the natural anatomy of a talus bone 3 has a bicondylar contour 5 .
- the ankle prosthesis of the present invention comprises a talar component and a tibial component.
- the talar component mimics the natural anatomy of the talus bone and the tibial component comprises a complimentary contour.
- the natural anatomy is mimicked in a reverse orientation, where a bicondylar contour is on a tibial component 7 and a talar component 9 comprises a complimentary contour.
- ankle prosthesis 1 comprises a two-component design which is sufficiently sized to prevent subsidence.
- ankle prosthesis 1 comprises tibial component 7 and talar component 9 .
- Tibial component 7 is configured for attachment to a tibia 11 .
- tibial component 7 comprises an attachment surface 13 positioned on a proximal portion of tibial component 7 and an articulation surface 15 positioned on a distal portion of tibial component 7 , wherein at least a portion of attachment surface 13 is configured for attachment to tibia 11 .
- the attachment surface and the articulation surface of tibial component 7 may comprise a unitary piece, or in an alternative embodiment the surfaces may be two distinct units attached to one another by any suitable means of attachment.
- Tibial component 7 may be attached to tibia 11 by any suitable means of attachment, e.g., one or more screws or one or more rods.
- An exemplary means of attachment 17 may be seen with reference to FIG. 3 .
- tibial component 7 functions as the “male” component of ankle prosthesis 1 .
- FIGS. 1-10 For example, referring to FIGS.
- articulation surface 15 of tibial component 7 comprises at least one convex contour 19 extending anteriorly-posteriorly on a medial portion of tibial component 7 , at least one convex contour 21 extending anteriorly-posteriorly on a lateral portion of tibial component 7 , and at least one concave contour 23 extending anteriorly-posteriorly in a sagittal plane of tibial component 7 .
- articulation surface 15 comprises a bicondylar contour which mimics the natural anatomy of the proximal portion of talus bone 3 .
- Radii of curvature of the at least one convex contour 19 on the medial portion and the at least one convex contour 21 on the lateral portion of articulation surface 15 of tibial component 13 may be the same, or in an alternative embodiment a radius of curvature of the medial portion may be greater, or in another embodiment a radius of curvature of the lateral portion may be greater.
- tibial component 7 functions as the “female” component of ankle prosthesis 1 .
- articulation surface 15 of tibial component 7 comprises at least one concave contour extending anteriorly-posteriorly on a medial portion of tibial component 7 , at least one concave contour extending anteriorly-posteriorly on a lateral portion of tibial component 7 , and at least one convex contour extending anteriorly-posteriorly in a sagittal plane of tibial component 7 .
- articulation surface 15 comprises a contour which is complimentary to a bicondylar contour.
- Radii of curvature of the at least one concave contour on the medial portion and the at least one concave contour on the lateral portion of articulation surface 15 of tibial component 13 may be the same, or in an alternative embodiment a radius of curvature of the medial portion may be greater, or in another embodiment a radius of curvature of the lateral portion may be greater.
- Complimentary talar component 9 is configured for attachment to talus 3 .
- Talar component 9 comprises an attachment surface 25 on a distal portion of the component and an articulation surface 27 on a proximal side of the component. At least a portion of attachment surface 25 is configured for attachment to talus 3 .
- the attachment surface and the articulation surface of talar component 9 may comprise a unitary piece, or in an alternative embodiment the surfaces may be two distinct units attached to one another by any suitable means of attachment.
- Talar component 9 may be attached to talus 3 by any suitable means of attachment, e.g., one or more screws or one or more rods.
- An exemplary means of attachment 29 may be seen with reference to FIG. 3 .
- Articulation surface 27 of talar component 9 is configured to compliment articulation surface 15 of tibial component 7 , and accordingly may comprise the “female” or “male” component of ankle prosthesis 1 depending on the configuration of tibial component 7 .
- Articulation surface 27 of talar component 9 comprises a contour for receiving articulation surface 15 of tibial component 7 .
- articulation surface 27 of talar component 9 has at least one concave contour 31 extending anteriorly-posteriorly on a medial portion of talar component 9 , at least one concave contour 33 extending anteriorly-posteriorly on a lateral portion of talar component 9 , and at least one convex contour 35 extending anteriorly-posteriorly on a sagittal plane of talar component 9 .
- Convex contour 35 is configured to compliment the at least one concave contour 23 on the sagittal plane of articulation surface 15 of tibial component 7 .
- At least one concave contour 31 on medial portion of articulation surface 27 of talar component 9 is configured to compliment the at least one convex contour 19 on the medial portion of articulation surface 15 of tibial component 7 and the at least one concave contour 33 on the lateral portion of articulation surface 27 of talar component 9 is configured to compliment the at least one convex contour 21 on the lateral portion of articulation surface 15 of tibial component 7 .
- Radii of curvature of the at least one concave contour 31 on the medial portion of talar component 9 and the at least one concave contour 33 on the lateral portion of talar component 9 may be the same, or in an alternative embodiment a radius of curvature on the medial portion may be greater, or in another embodiment a radius of curvature of the lateral portion may be greater.
- talar component 9 comprises the “male” component of ankle prosthesis 1 .
- articulation surface 27 of talar component 9 has at least one convex contour extending anteriorly-posteriorly on a medial portion of talar component 9 , at least one convex contour extending anteriorly-posteriorly on a lateral portion of talar component 9 , and at least one concave contour extending anteriorly-posteriorly on a sagittal plane of talar component 9 .
- Concave contour is configured to compliment the at least one convex contour on the sagittal plane of articulation surface 15 of tibial component 7 .
- At least one convex contour on medial portion of articulation surface 27 of talar component 9 is configured to compliment the at least one concave contour on the medial portion of articulation surface 15 of tibial component 7
- the at least one convex contour on the lateral portion of articulation surface 27 of talar component 9 is configured to compliment the at least one concave contour on the lateral portion of articulation surface 15 of tibial component 7 .
- Radii of curvature of the at least one convex contour on the medial portion of talar component 9 and the at least one convex contour 33 on the lateral portion of talar component 9 may be the same, or in an alternative embodiment a radius of curvature on the medial portion may be greater, or in another embodiment a radius of curvature of the lateral portion may be greater.
- Articulation surface 15 of tibial component 7 and articulation surface 27 of talar component 9 form an articulation interface 37 . Congruence of the articulation surfaces is maintained in all positions of an ankle joint movement, including dorsiflexion/plantarflexion, inversion/eversion, and internal/external rotation.
- one embodiment of the present invention comprises a lip on the female component.
- the lip is configured to maintain congruence of the articulation surfaces in patients having compromised soft tissues by at least partially limiting mobility in a direction toward the compromised soft tissue. Congruence of the articulation surfaces may be maintained when the articulation surfaces correspond to one another and are in agreement for each direction of motion.
- a lip 39 is configured to stabilize prosthesis 1 when implanted in patients with compromised soft tissues on a medial side of the ankle.
- lip 39 may be configured for implantation in a patient with a compromised deltoid ligament 41 (depicted in FIG. 2 with talar component 9 being the “female” component).
- lip 39 comprises a raised surface on a medial edge 43 of articulation surface 27 of talar component 9 such that the raised surface extends to a position which is in superior relation to a medial edge 45 of articulation surface 15 of tibial component 7 .
- the raised surface constrains movement in a medial direction, or eversion of the implant.
- the lip comprises a raised surface on a medial edge of articulation surface of tibial component 7 such that the raised surface extends to a position which is in inferior relation to a medial edge of the articulation surface of talar component 9 (not depicted).
- the lip is configured to stabilize prosthesis 1 when implanted in patients with compromised soft tissues on a lateral side of the ankle, such as a compromised anterior inferior tibiofibular ligament 47 (depicted in FIG. 2 ), for example.
- a lip 49 comprises a raised surface on a lateral edge 51 of talar component 9 such that the raised surface extends to a position which is in superior relation to a lateral edge 53 of articulation surface 15 of tibial component 7 .
- the raised surface constrains movement in a lateral direction, or inversion of the implant.
- the lip comprises a raised surface on a lateral edge of articulation surface of tibial component 7 such that the raised surface extends to a position which is in inferior relation to a lateral edge of the articulation surface of talar component 9 (not depicted).
- prosthesis 1 is provided for implantation in patients with compromised soft tissues on both the medial and lateral sides of the ankle.
- the lip comprises a first raised surface 39 on medial edge 43 of talar component 9 such that the raised surface extends to a position which is in superior relation to medial edge 45 of articulation surface 15 of tibial component 7 and a second raised surface 49 on lateral edge 51 of talar component 9 such that the raised surface extends to a position which is in superior relation to lateral edge 53 of articulation surface 15 of tibial component 7 .
- varus/valgus freedom of movement is constrained, but there is freedom of movement for dorsiflexion/plantarflexion.
- tibial component 7 is the “female” component and comprises the lip.
- prosthesis 1 is provided for implantation in patients with compromised soft tissue on a posterior side of the ankle.
- the lip comprises a raised surface (see FIG. 5 ) on a posterior edge 55 of talar component 9 such that the raised surface extends to a position which is in superior relation to a posterior edge 57 of articulation surface 15 of tibial component 7 .
- posterior displacement of tibial component 7 is prevented.
- tibial component 7 is the “female” component and comprises the lip to prevent posterior displacement of talar component 9 .
- the lip may also be configured for implantation in patients with compromised soft tissue on an anterior side of the ankle.
- the lip comprises a raised surface (see FIG. 5 ) on an anterior edge of talar component 9 such that the raised surface extends to a position which is in superior relation to an anterior edge of articulation surface 15 of tibial component 7 .
- anterior displacement of tibial component 7 is prevented.
- tibial component 7 is the “female” component and comprises the lip to prevent anterior displacement of talar component 9 .
- prosthesis 1 is provided for implantation in patients with compromised soft tissue such that stabilization of the implant and constraint of movement is necessary in more than one direction of mobility.
- the lip comprises a raised surface (not shown) extending from medial edge 43 of articulation surface 27 of talar component 9 posteriorly curving to lateral edge 51 of articulation surface 27 of talar component 9 and continuing around returning to medial edge 43 .
- the lip extends to a position which is in superior relation to articulation surface 15 of tibial component 7 .
- the lip comprises a general cup-like contour providing stabile implantation in patients with more severe soft tissue impairment.
- tibial component 7 is the “female” component and comprises the cup-like lip.
- articulation surface 15 of tibial component 7 is comprised of a first material and articulation surface 27 of talar component 9 is comprised of a second material.
- the first material and the second material may be substantially the same.
- first and second material are substantially different.
- tibial component and talar component are each comprised of an attachment surface and an articulation surface.
- the articulation surface and attachment surface of tibial component 7 may comprise materials which are substantially the same, or in an alternative embodiment the surfaces may comprise materials which are substantially different.
- the articulation surface and attachment surface of talar component 9 may comprise materials which are substantially the same, or in an alternative embodiment the surfaces may comprise materials which are substantially different.
- one embodiment of the present invention comprises a material of construction which promotes osseointegration.
- the material may comprise pores into which osteoblasts and supporting tissues can migrate.
Abstract
The present invention relates to a stabilized ankle prosthesis configured for use in patients with compromised soft tissue in the ankle. The prosthesis of the present invention is a two-component design comprising a stabilizing lip configured to constrain movement in the general direction of compromised soft tissue.
Description
- This application is a continuation of U.S. patent application Ser. No. 13/674,504, filed on Nov. 12, 2012, the entirety of which is incorporated herein by reference for all purposes.
- An ankle joint may become severely damaged and painful due to arthritis from prior ankle surgery, bone fracture, infection, osteoarthritis, posttraumatic osteoarthritis or rheumatoid arthritis, for example. Options for treating the injured ankle have included anti-inflammatory and pain medications, braces, physical therapy, amputation, joint arthrodesis, and total ankle replacement.
- In the past the main-stay of ankle arthrosis has been joint arthrodesis, due to the poor prosthetic survival rate of total ankle replacements. This is primarily due to the clinical results of early ankle designs. Therefore, arthrodesis has been the only choice for many surgeons and patients. Arthrodesis improves stability and reduces pain, but also severely inhibits normal function of the ankle joint. Although some patients have very good results from ankle fusion, surrounding joints above and below the fusion may become arthritic and painful because the lack of ambulation places additional stress on these joints.
- There have been numerous ankle joint replacement prostheses developed over the last 30 years. The Agility ankle is an example of an early implant design. It is comprised of two components—one part is cemented to the tibia and the other part is cemented to the talus. An issue with the design of the early ankle prostheses is that although they allow for some dorsiflexion/plantarflexion motion, the articulation surfaces restrict varus/valgus and rotation motions. Another problem surrounding early implant designs is their reliance on the surrounding soft tissues of the ankle to stabilize the implant. As a result, they are not well suited for implantation in individuals with compromised soft tissues.
- Another example is the Salto Talaris ankle device, which is a fixed-bearing ankle prosthesis. This two-component ankle system utilizes a conical talar component with two different radii of curvature and a curved groove in the sagittal plane. The medial radius is smaller than the lateral to allow equal tensioning of the collateral ligaments. The tibial component is designed for a fixed insertion of a polyethylene bearing piece that is replaceable. Some issues with the fixed-bearing prostheses include high wear rate of the articulation surfaces, ambulatory constraint, and loosening of the implant.
- Another ankle replacement device is the Scandinavian Total Ankle Replacement (STAR). In this device the tibial component is designed for less bone resection and has two parallel bars for insertion into the subchondral bone. The talar component is meant to mimic the talar dome and has a central ridge for stabilization of a polyethylene piece. The STAR prosthesis inhibits inversion/eversion coupling with plantarflexion/dorsiflexion motion. This leads to straining and potential damage to the deltoid ligaments on the medial side of the ankle. Another issue with this device is edge loading, which puts a great amount of stress on the ridge of the implant and results in the implant retracting from the talus.
- More modern designs have attempted to increase the range of motion while maintaining the integrity of the surrounding soft tissues of the ankle. For example, U.S. Pat. No. 7,625,409 discloses a prosthesis designed to allow full range of motion while minimizing edge loading and subsidence. However, this prosthesis fails to address the need for an implant for use in patients with compromised soft tissues in the ankle.
-
FIG. 1 shows an anterior view of an ankle prosthesis according to an embodiment of the present invention; -
FIG. 2 shows an anterior view of an ankle joint and surrounding soft tissues; -
FIG. 3 shows an anterior view of exemplary means of attachment of an ankle prosthesis according to an embodiment of the present invention; -
FIG. 4 shows a posterior view of an ankle prosthesis according to an embodiment of the present invention; and -
FIG. 5 shows a medial view of an ankle prosthesis according to an embodiment of the present invention. - Although detailed embodiments of the present invention are disclosed herein, it is to be understood that the invention is not restricted to the details of the embodiments. Many changes in design, composition, configuration and dimensions are possible without departing from the spirit and scope of the instant invention. Further, the figures are not necessarily to scale. Some features may be exaggerated to show details of particular components. Specific structural and functional details disclosed herein are not to be interpreted as limiting, but as an aid for teaching one skilled in the art how to variously employ the present invention. Accordingly, it should be readily understood that the embodiments described and illustrated herein are illustrative only, and are not to be considered as limitations upon the scope of the present invention.
- An ankle joint is a very complex joint having three motions that occur simultaneously: dorsiflexion/plantarflexion, varus/valgus, and internal/external rotation. In a healthy ankle, the ankle joint relies on soft tissues, including ligaments, to provide stability. These tissues include, for example, an anterior inferior tibiofibular ligament, a calcaneal-fibular ligament, a posterior talo-fibular ligament, a syndesmotic ligament, an anterior capsule of the ankle joint (which helps keep the ankle from anterior movement), and a deltoid ligament. These soft tissues contribute to the overall function of the ankle by ensuring joint stability.
- In a healthy ankle these ligaments naturally stretch according to specific ankle motions in order to keep the joint secure. It is desirable that an ankle replacement prosthesis prevents stretching these ligaments beyond their natural range of motion. Further, because the ankle joint absorbs a stress greater than four times the body's weight with every step, an ankle replacement prosthesis ideally will be able to withstand the pressures associated with weight-bearing and motion.
- In a patient with healthy soft tissue in the ankle, this tissue will provide stability to a prosthesis. However, when the soft tissue is compromised, a prosthesis can fail for various reasons, including instability. Therefore, there exists a need for an implant that provides ambulation of the ankle joint similar to that of a natural ankle and that remains stable when implanted in a patient with compromised soft tissues.
- An
ankle prosthesis 1 of the present invention addresses these and additional problems.Ankle prosthesis 1 of the present invention provides adequate range of motion for the primary degrees of freedom of the talar joint, including movement in a frontal plane and a sagittal plane. Additionally,ankle prosthesis 1 of the present invention provides stability for implantation into an ankle joint with compromised soft tissues by constraining movement in the general direction of compromised soft tissues. - As may be seen with reference to
FIG. 2 , the natural anatomy of atalus bone 3 has abicondylar contour 5. The ankle prosthesis of the present invention comprises a talar component and a tibial component. In one embodiment, the talar component mimics the natural anatomy of the talus bone and the tibial component comprises a complimentary contour. In another embodiment depicted inFIG. 1 , the natural anatomy is mimicked in a reverse orientation, where a bicondylar contour is on atibial component 7 and atalar component 9 comprises a complimentary contour. - In one embodiment of the present invention,
ankle prosthesis 1 comprises a two-component design which is sufficiently sized to prevent subsidence. With reference toFIG. 1 ,ankle prosthesis 1 comprisestibial component 7 andtalar component 9.Tibial component 7 is configured for attachment to atibia 11. As may be seen inFIG. 3 ,tibial component 7 comprises anattachment surface 13 positioned on a proximal portion oftibial component 7 and an articulation surface 15 positioned on a distal portion oftibial component 7, wherein at least a portion ofattachment surface 13 is configured for attachment totibia 11. The attachment surface and the articulation surface oftibial component 7 may comprise a unitary piece, or in an alternative embodiment the surfaces may be two distinct units attached to one another by any suitable means of attachment. -
Tibial component 7 may be attached totibia 11 by any suitable means of attachment, e.g., one or more screws or one or more rods. An exemplary means ofattachment 17 may be seen with reference toFIG. 3 . In one embodiment,tibial component 7 functions as the “male” component ofankle prosthesis 1. For example, referring toFIGS. 1 and 3 , articulation surface 15 oftibial component 7 comprises at least oneconvex contour 19 extending anteriorly-posteriorly on a medial portion oftibial component 7, at least oneconvex contour 21 extending anteriorly-posteriorly on a lateral portion oftibial component 7, and at least oneconcave contour 23 extending anteriorly-posteriorly in a sagittal plane oftibial component 7. In this embodiment, articulation surface 15 comprises a bicondylar contour which mimics the natural anatomy of the proximal portion oftalus bone 3. Radii of curvature of the at least oneconvex contour 19 on the medial portion and the at least oneconvex contour 21 on the lateral portion of articulation surface 15 oftibial component 13 may be the same, or in an alternative embodiment a radius of curvature of the medial portion may be greater, or in another embodiment a radius of curvature of the lateral portion may be greater. - In an alternative embodiment,
tibial component 7 functions as the “female” component ofankle prosthesis 1. In this embodiment articulation surface 15 oftibial component 7 comprises at least one concave contour extending anteriorly-posteriorly on a medial portion oftibial component 7, at least one concave contour extending anteriorly-posteriorly on a lateral portion oftibial component 7, and at least one convex contour extending anteriorly-posteriorly in a sagittal plane oftibial component 7. In this embodiment, articulation surface 15 comprises a contour which is complimentary to a bicondylar contour. Radii of curvature of the at least one concave contour on the medial portion and the at least one concave contour on the lateral portion of articulation surface 15 oftibial component 13 may be the same, or in an alternative embodiment a radius of curvature of the medial portion may be greater, or in another embodiment a radius of curvature of the lateral portion may be greater. -
Complimentary talar component 9 is configured for attachment totalus 3.Talar component 9 comprises anattachment surface 25 on a distal portion of the component and anarticulation surface 27 on a proximal side of the component. At least a portion ofattachment surface 25 is configured for attachment totalus 3. The attachment surface and the articulation surface oftalar component 9 may comprise a unitary piece, or in an alternative embodiment the surfaces may be two distinct units attached to one another by any suitable means of attachment. -
Talar component 9 may be attached totalus 3 by any suitable means of attachment, e.g., one or more screws or one or more rods. An exemplary means ofattachment 29 may be seen with reference toFIG. 3 .Articulation surface 27 oftalar component 9 is configured to compliment articulation surface 15 oftibial component 7, and accordingly may comprise the “female” or “male” component ofankle prosthesis 1 depending on the configuration oftibial component 7.Articulation surface 27 oftalar component 9 comprises a contour for receiving articulation surface 15 oftibial component 7. In one embodiment of the present invention in which talarcomponent 9 comprises the “female” component ofankle prosthesis 1,articulation surface 27 oftalar component 9 has at least oneconcave contour 31 extending anteriorly-posteriorly on a medial portion oftalar component 9, at least oneconcave contour 33 extending anteriorly-posteriorly on a lateral portion oftalar component 9, and at least oneconvex contour 35 extending anteriorly-posteriorly on a sagittal plane oftalar component 9.Convex contour 35 is configured to compliment the at least oneconcave contour 23 on the sagittal plane of articulation surface 15 oftibial component 7. At least oneconcave contour 31 on medial portion ofarticulation surface 27 oftalar component 9 is configured to compliment the at least oneconvex contour 19 on the medial portion of articulation surface 15 oftibial component 7 and the at least oneconcave contour 33 on the lateral portion ofarticulation surface 27 oftalar component 9 is configured to compliment the at least oneconvex contour 21 on the lateral portion of articulation surface 15 oftibial component 7. Radii of curvature of the at least oneconcave contour 31 on the medial portion oftalar component 9 and the at least oneconcave contour 33 on the lateral portion oftalar component 9 may be the same, or in an alternative embodiment a radius of curvature on the medial portion may be greater, or in another embodiment a radius of curvature of the lateral portion may be greater. - In an alternative embodiment,
talar component 9 comprises the “male” component ofankle prosthesis 1. In this embodiment,articulation surface 27 oftalar component 9 has at least one convex contour extending anteriorly-posteriorly on a medial portion oftalar component 9, at least one convex contour extending anteriorly-posteriorly on a lateral portion oftalar component 9, and at least one concave contour extending anteriorly-posteriorly on a sagittal plane oftalar component 9. Concave contour is configured to compliment the at least one convex contour on the sagittal plane of articulation surface 15 oftibial component 7. At least one convex contour on medial portion ofarticulation surface 27 oftalar component 9 is configured to compliment the at least one concave contour on the medial portion of articulation surface 15 oftibial component 7, and the at least one convex contour on the lateral portion ofarticulation surface 27 oftalar component 9 is configured to compliment the at least one concave contour on the lateral portion of articulation surface 15 oftibial component 7. Radii of curvature of the at least one convex contour on the medial portion oftalar component 9 and the at least oneconvex contour 33 on the lateral portion oftalar component 9 may be the same, or in an alternative embodiment a radius of curvature on the medial portion may be greater, or in another embodiment a radius of curvature of the lateral portion may be greater. - Articulation surface 15 of
tibial component 7 and articulation surface 27 oftalar component 9 form anarticulation interface 37. Congruence of the articulation surfaces is maintained in all positions of an ankle joint movement, including dorsiflexion/plantarflexion, inversion/eversion, and internal/external rotation. - In order to maintain congruence of the articulation surfaces of
prosthesis 1 when implanted in an ankle with compromised soft tissue, one embodiment of the present invention comprises a lip on the female component. The lip is configured to maintain congruence of the articulation surfaces in patients having compromised soft tissues by at least partially limiting mobility in a direction toward the compromised soft tissue. Congruence of the articulation surfaces may be maintained when the articulation surfaces correspond to one another and are in agreement for each direction of motion. - In one embodiment of the present invention, a
lip 39 is configured to stabilizeprosthesis 1 when implanted in patients with compromised soft tissues on a medial side of the ankle. For example,lip 39 may be configured for implantation in a patient with a compromised deltoid ligament 41 (depicted inFIG. 2 withtalar component 9 being the “female” component). In this embodiment,lip 39 comprises a raised surface on amedial edge 43 ofarticulation surface 27 oftalar component 9 such that the raised surface extends to a position which is in superior relation to amedial edge 45 of articulation surface 15 oftibial component 7. In this embodiment, the raised surface constrains movement in a medial direction, or eversion of the implant. In an alternative embodiment in whichtibial component 7 is the “female” component, the lip comprises a raised surface on a medial edge of articulation surface oftibial component 7 such that the raised surface extends to a position which is in inferior relation to a medial edge of the articulation surface of talar component 9 (not depicted). - In another embodiment of the present invention, the lip is configured to stabilize
prosthesis 1 when implanted in patients with compromised soft tissues on a lateral side of the ankle, such as a compromised anterior inferior tibiofibular ligament 47 (depicted inFIG. 2 ), for example. In this embodiment, alip 49 comprises a raised surface on alateral edge 51 oftalar component 9 such that the raised surface extends to a position which is in superior relation to alateral edge 53 of articulation surface 15 oftibial component 7. In this embodiment, the raised surface constrains movement in a lateral direction, or inversion of the implant. In an alternative embodiment in whichtibial component 7 is the “female” component, the lip comprises a raised surface on a lateral edge of articulation surface oftibial component 7 such that the raised surface extends to a position which is in inferior relation to a lateral edge of the articulation surface of talar component 9 (not depicted). - In another embodiment,
prosthesis 1 is provided for implantation in patients with compromised soft tissues on both the medial and lateral sides of the ankle. In this embodiment, the lip comprises a first raisedsurface 39 onmedial edge 43 oftalar component 9 such that the raised surface extends to a position which is in superior relation tomedial edge 45 of articulation surface 15 oftibial component 7 and a second raisedsurface 49 onlateral edge 51 oftalar component 9 such that the raised surface extends to a position which is in superior relation tolateral edge 53 of articulation surface 15 oftibial component 7. In this embodiment, varus/valgus freedom of movement is constrained, but there is freedom of movement for dorsiflexion/plantarflexion. In an alternative embodiment,tibial component 7 is the “female” component and comprises the lip. - With reference to
FIGS. 4 and 5 , in anotherembodiment prosthesis 1 is provided for implantation in patients with compromised soft tissue on a posterior side of the ankle. In this embodiment, the lip comprises a raised surface (seeFIG. 5 ) on aposterior edge 55 oftalar component 9 such that the raised surface extends to a position which is in superior relation to aposterior edge 57 of articulation surface 15 oftibial component 7. In this embodiment, posterior displacement oftibial component 7 is prevented. In an alternative embodiment,tibial component 7 is the “female” component and comprises the lip to prevent posterior displacement oftalar component 9. - The lip may also be configured for implantation in patients with compromised soft tissue on an anterior side of the ankle. In this embodiment, the lip comprises a raised surface (see
FIG. 5 ) on an anterior edge oftalar component 9 such that the raised surface extends to a position which is in superior relation to an anterior edge of articulation surface 15 oftibial component 7. In this embodiment, anterior displacement oftibial component 7 is prevented. In an alternative embodiment,tibial component 7 is the “female” component and comprises the lip to prevent anterior displacement oftalar component 9. - In another embodiment,
prosthesis 1 is provided for implantation in patients with compromised soft tissue such that stabilization of the implant and constraint of movement is necessary in more than one direction of mobility. The lip comprises a raised surface (not shown) extending frommedial edge 43 ofarticulation surface 27 oftalar component 9 posteriorly curving tolateral edge 51 ofarticulation surface 27 oftalar component 9 and continuing around returning tomedial edge 43. The lip extends to a position which is in superior relation to articulation surface 15 oftibial component 7. In this configuration, the lip comprises a general cup-like contour providing stabile implantation in patients with more severe soft tissue impairment. In an alternative embodiment,tibial component 7 is the “female” component and comprises the cup-like lip. - Another consideration for providing a successful total ankle replacement prosthesis is the material or materials of construction. In order to reduce wearing of the components, and therefore failure of the prosthesis, it is desirable to use a material, or a combination of materials, which create minimal friction between the two components. Suitable materials include those which minimize friction and resultant wear of the articulation surfaces. Some exemplary materials include a metal, a polymer, or a ceramic material. However, other suitable materials are contemplated within the spirit and scope of the present invention. In one embodiment of the present invention, articulation surface 15 of
tibial component 7 is comprised of a first material and articulation surface 27 oftalar component 9 is comprised of a second material. The first material and the second material may be substantially the same. In an alternative embodiment, the first and second material are substantially different. Further, tibial component and talar component are each comprised of an attachment surface and an articulation surface. The articulation surface and attachment surface oftibial component 7 may comprise materials which are substantially the same, or in an alternative embodiment the surfaces may comprise materials which are substantially different. Likewise, the articulation surface and attachment surface oftalar component 9 may comprise materials which are substantially the same, or in an alternative embodiment the surfaces may comprise materials which are substantially different. - Additionally, it may be desirable to use a material which promotes osseointegration, so that a direct interface between
attachment surface 25 oftalar component 9 andtalus 3, and in betweenattachment surface 13 oftibial component 7 andtibia 11, are formed. To this end, one embodiment of the present invention comprises a material of construction which promotes osseointegration. For example, the material may comprise pores into which osteoblasts and supporting tissues can migrate.
Claims (13)
1.-20. (canceled)
21. An ankle prosthesis comprising:
a tibial component configured for attachment to a tibia, comprising a body having at least one side and an attachment surface on a proximal portion, the at least one side tapers inwardly toward the attachment surface, the at least one side and the attachment surface of the body being adapted to fit a recess formed in a resected tibia, the tibial component having an articulation surface on a distal portion that is wider than the attachment surface; and
a talar component configured for attachment to a talus, comprising an attachment surface on a distal portion, an articulation surface on a proximal portion, and a raised surface on a medial portion, wherein the raised surface is configured to:
(i) be superior in relation to the articulation surface and
(ii) limit eversion, wherein the articulation surface of the talar component complements the articulation surface of the tibial component.
22. The ankle prosthesis of claim 21 , wherein the talar component further includes a second raised surface on a lateral portion, wherein the second raised surface is configured to be superior in relation to the articulation surface and is configured to limit inversion.
23. The ankle prosthesis of claim 21 , wherein the talar component includes a first raised surface on a posterior edge configured to be superior in relation to the articulation surface of the tibial component to limit posterior displacement of the tibial component, and the talar component includes a second raised surface on an anterior edge, wherein the second raised surface is configured to be superior in relation to the articulation surface of the tibial component to limit anterior displacement of the tibial component.
24. The ankle prosthesis of claim 21 , wherein the articulation surface of the tibial component comprises a first material and the articulation surface of the talar component comprises a second material, wherein the first and second material are different.
25. The ankle prosthesis of claim 21 , wherein the proximal portion of the tibial component is convex and shaped to fit a concave opening formed in the tibia.
26. The ankle prosthesis of claim 21 , wherein the articulation surface of the tibial component has a bicondylar contour.
27. An ankle prosthesis comprising:
a tibial component configured for attachment to a tibia, comprising a body having at least one side and an attachment surface on a proximal portion, the at least one side tapers inwardly toward the attachment surface, the at least one side and the attachment surface of the body being adapted to fit a recess formed in a resected tibia, the tibial component having an articulation surface on a distal portion that is wider than the attachment surface; and
a talar component configured for attachment to a talus, comprising an attachment surface on a distal portion, an articulation surface on a proximal portion, and a raised surface on a lateral portion wherein the raised surface is configured to (i) be superior in relation to the articulation surface and (ii) limit inversion, wherein the raised surface is configured to be superior in relation to the articulation surface and limit eversion.
28. An ankle prosthesis comprising:
a tibial component configured for attachment to a tibia, including an attachment surface on a proximal portion, an articulation surface on a distal portion, and at least one side extending between the proximal portion and the distal portion, the at least one side tapering inward toward the attachment surface, the at least one side and the attachment surface adapted to fit into a recess formed in a resected tibia, the articulation surface being wider than the attachment surface, a first surface located on a posterior edge configured to be superior in relation to the articulation surface and a second surface on an anterior edge configured to be superior in relation to the articulation surface;
a talar component having an attachment surface on a distal portion and an articulation surface on a proximal portion, wherein the articulation surface includes a medial portion and a lateral portion, the medial portion having a first convex contour, the lateral portion having a second convex contour, wherein a concave contour is located between the first and second convex contours;
wherein the articulation surface of the tibial component comprises a medial portion having a second concave contour and a lateral portion having a third concave contour such that a third convex contour may be located between the second and third concave contours, and the articulation surface of the talar component complements the articulation surface of the talar component.
29. The ankle prosthesis of claim 28 , wherein the tibial component includes a raised surface on the medial portion, and wherein the raised surface is configured to be superior in relation to the articulation surface and configured to limit eversion.
30. The ankle prosthesis of claim 28 , wherein the tibial component includes a raised surface on the lateral portion, and wherein the raised surface is configured to be superior in relation to the articulation surface of the tibial component and to limit inversion.
31. The ankle prosthesis of claim 29 or 30 , wherein the tibial component includes a raised surface on the medial portion, and wherein the raised surface on the medial portion is configured to be superior in relation to the articulation surface of the talar component to limit eversion, and the tibial component further includes a raised surface on the lateral portion, and wherein the raised surface on the lateral portion is configured to be superior in relation to the articulation surface of the talar component and is configured to limit inversion.
32. The ankle prosthesis of claim 29 or 30 , wherein the articulation surface of the tibial component is comprised of a first material and the articulation surface of the talar component is comprised of a second material, wherein the first and second material are different.
Priority Applications (1)
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US17/376,242 US20210338449A1 (en) | 2012-11-12 | 2021-07-15 | Stabilized total ankle prosthesis |
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US13/674,504 US9750613B2 (en) | 2012-11-12 | 2012-11-12 | Stabilized total ankle prosthesis |
US15/688,371 US10413417B2 (en) | 2012-11-12 | 2017-08-28 | Stabilized total ankle prosthesis |
US16/534,218 US11219529B2 (en) | 2012-11-12 | 2019-08-07 | Stabilized total ankle prosthesis |
US17/376,242 US20210338449A1 (en) | 2012-11-12 | 2021-07-15 | Stabilized total ankle prosthesis |
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US16/534,218 Active 2033-05-21 US11219529B2 (en) | 2012-11-12 | 2019-08-07 | Stabilized total ankle prosthesis |
US17/376,242 Abandoned US20210338449A1 (en) | 2012-11-12 | 2021-07-15 | Stabilized total ankle prosthesis |
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US16/534,218 Active 2033-05-21 US11219529B2 (en) | 2012-11-12 | 2019-08-07 | Stabilized total ankle prosthesis |
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WO2014149952A1 (en) * | 2013-03-15 | 2014-09-25 | Drexel University | Prosthetic ankle with conic saddle shaped joint |
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JP6745804B2 (en) | 2015-01-08 | 2020-08-26 | メダクタ・インターナショナル・ソシエテ・アノニム | Joint prosthesis with removal device |
CN105030385A (en) * | 2015-08-27 | 2015-11-11 | 江苏奥康尼医疗科技发展有限公司 | All-organic high molecular material ankle joint prosthesis |
FR3070593A1 (en) * | 2017-09-05 | 2019-03-08 | In2Bones | PROSTHESIS OF IMPROVED ANKLE |
EP3784148A4 (en) | 2018-04-24 | 2022-01-19 | Paragon 28, Inc. | Implants and methods of use and assembly |
TWI786139B (en) * | 2018-06-22 | 2022-12-11 | 財團法人工業技術研究院 | Artificial joint |
USD920517S1 (en) | 2020-01-08 | 2021-05-25 | Restor3D, Inc. | Osteotomy wedge |
USD920515S1 (en) | 2020-01-08 | 2021-05-25 | Restor3D, Inc. | Spinal implant |
US11806028B1 (en) | 2022-10-04 | 2023-11-07 | Restor3D, Inc. | Surgical guides and processes for producing and using the same |
US11960266B1 (en) | 2023-08-23 | 2024-04-16 | Restor3D, Inc. | Patient-specific medical devices and additive manufacturing processes for producing the same |
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US10413417B2 (en) | 2019-09-17 |
US11219529B2 (en) | 2022-01-11 |
US9750613B2 (en) | 2017-09-05 |
US20190358047A1 (en) | 2019-11-28 |
US20140135939A1 (en) | 2014-05-15 |
US20180008425A1 (en) | 2018-01-11 |
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