EP4719280A1 - Anterior tibial approach for total ankle replacement - Google Patents

Anterior tibial approach for total ankle replacement

Info

Publication number
EP4719280A1
EP4719280A1 EP24832823.9A EP24832823A EP4719280A1 EP 4719280 A1 EP4719280 A1 EP 4719280A1 EP 24832823 A EP24832823 A EP 24832823A EP 4719280 A1 EP4719280 A1 EP 4719280A1
Authority
EP
European Patent Office
Prior art keywords
fixation component
prosthetic implant
fixation
height
arm
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.)
Pending
Application number
EP24832823.9A
Other languages
German (de)
French (fr)
Inventor
Maris PRIEDITIS
Chris Powell
Braham Dhillon
Mihaela Morar
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Arthrex Inc
Original Assignee
Arthrex Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Arthrex Inc filed Critical Arthrex Inc
Publication of EP4719280A1 publication Critical patent/EP4719280A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/42Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4202Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for ankles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30884Fins or wings, e.g. longitudinal wings for preventing rotation within the bone cavity
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
    • A61F2002/30891Plurality of protrusions
    • A61F2002/30892Plurality of protrusions parallel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3092Special external or bone-contacting surface, e.g. coating for improving bone ingrowth having an open-celled or open-pored structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/3093Special external or bone-contacting surface, e.g. coating for improving bone ingrowth for promoting ingrowth of bone tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/3094Designing or manufacturing processes
    • A61F2002/30985Designing or manufacturing processes using three dimensional printing [3DP]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/42Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
    • A61F2/4202Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for ankles
    • A61F2002/4205Tibial components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00023Titanium or titanium-based alloys, e.g. Ti-Ni alloys

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

The present disclosure provides prosthetic implants for tibial fixation in a total ankle replacement device. Methods including the devices are also disclosed.

Description

Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO ANTERIOR TIBIAL APPROACH FOR TOTAL ANKLE REPLACEMENT CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of priority to U.S. Provisional Application No. 63/511,255 entitled “Anterior Tibial Approach for Total Ankle Replacement,” filed on June 30, 2023, the contents of which are hereby incorporated by reference in their entirety. BACKGROUND [0002] Total ankle replacement (TAR) requires fixation of the tibial component to the tibia of a patient, and further requires fixation of the talar component to the talus of the patient. Improving time zero fixation by the inclusion of high retention force features my aide in the long term survival of the prosthetic implant. Accordingly, disclosed herein are prosthetic implants that provide a high retention force to aid in preventing loosening after initial implantation. SUMMARY [0003] Total ankle replacement (TAR) requires a prosthesis to replace resected bone and eroded joint cartilage. The component that replaces the distal tibia historically has left room for improvement for initial fixation (time zero fixation) to bone. Some of the challenges lay within the exposure required to use instruments that would adequately prepare the bone for the final implant. Fixation that includes vertical pegs are the most difficult prepare due to lack of exposure in the ankle joint space. Angled pegs have been used to solve the issue of exposure: however, the time zero fixation for such design leaves room for improvement. Other previous designs have used an anterior approach where the anterior cortex is breached using drills and osteotomes. These drills are large in size and create large bone voids that require back filling with autograft, allograft, or synthetic bone void fillers once the implant is seated. Accordingly, such designs have raised concerns of weakening the weight bearing anterior cortical bone. [0004] Accordingly, the present disclosure provides a tibial tray that incorporates an anterior approach but with a minimal breach of bone tissue. The fixation would also be designed in a manner that when impacted to final position, the tibial tray provides compression with respect to the resected bone, thereby helping to improve time zero fixation. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO [0005] Thus, in one aspect, a prosthetic implant includes a body comprising a first side and a second side opposite the first side. The first side comprises a bone contact surface, and the second side is configured to be coupled to an articulation surface. The prosthetic implant also includes at least one fixation component extending away from the first side of the body. The at least one fixation component includes a first end and a second end opposite the first end, and the first end of the at least one fixation component includes a cutting surface. [0006] In one example embodiment of the first aspect, the first end of the at least one fixation component has a first width, and the second end of the at least one fixation component has a second width that is greater than the first width. [0007] In another example embodiment of the first aspect, the body includes a first end and a second end opposite the first end, and the first end of the at least one fixation component is offset from the first end of the body. [0008] In another example embodiment of the first aspect, the second end of the at least one fixation component is offset from the second end of the body. [0009] In another example embodiment of the first aspect, the second end of the at least one fixation component is aligned with the second end of the body. [0010] In another example embodiment of the first aspect, the body comprises a first material, and the at least one fixation component comprises a second material that is different from the first material. [0011] In another example embodiment of the first aspect, the first material comprises titanium, and wherein the second material comprises a nickel-titanium alloy. [0012] In another example embodiment of the first aspect, the at least one fixation component includes one or more through-holes between the first end and the second end. [0013] In another example embodiment of the first aspect, the at least one fixation component includes a first side and a second side opposite the first side, and the first side and the second side of the at least one fixation component each include a plurality of indents positioned between the first end and the second end. [0014] In another example embodiment of the first aspect, the at least one fixation component includes a first side and a second side opposite the first side, and the first side and the second side of the at least one fixation component each include a plurality of channels extending from the first end to the second end. [0015] In another example embodiment of the first aspect, the at least one fixation component includes a bottom portion coupled to the first side of the body and a top portion Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO coupled to the bottom portion, and a width of the top portion is greater than a width of the bottom portion. [0016] In another example embodiment of the first aspect, the top portion includes a first side and a second side opposite the first side, and the first side and the second side of the top portion each include a serrated edge. [0017] In another example embodiment of the first aspect, the at least one fixation component comprises a first fixation component and a second fixation component, the first fixation component includes a first end and a second end opposite the first end, wherein the first end of the first fixation component comprises a first cutting surface, the second fixation component includes a first end and a second end opposite the first end, and the first end of the second fixation component comprises a second cutting surface. [0018] In another example embodiment of the first aspect, the first cutting surface and the second cutting surface are serrated. [0019] In another example embodiment of the first aspect, a height of the first end of the first fixation component is less than a height of the second end of the first fixation component, and a height of the first end of the second fixation component is less than a height of the second end of the second fixation component. [0020] In another example embodiment of the first aspect, the first fixation component curves towards a centerline of the body with a radius of curvature greater than zero, and the second fixation component curves towards the centerline of the body with the radius of curvature. [0021] In another example embodiment of the first aspect, the first fixation component curves away from a centerline of the body with a radius of curvature greater than zero, and wherein the second fixation component curves away from the centerline of the body with the radius of curvature. [0022] In another example embodiment of the first aspect, a height of the first end of the at least one fixation component is less than a height of the second end of the at least one fixation component. [0023] In another example embodiment of the first aspect, the at least one fixation component includes a bottom portion coupled to the first side of the body and a top portion coupled to the bottom portion. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO [0024] In another example embodiment of the first aspect, the top portion includes a first arm extending vertically and laterally away from the bottom portion and a second arm extending vertically and laterally away from the bottom portion. [0025] In another example embodiment of the first aspect, the first arm has a radius of curvature greater than zero, and the second arm has the radius of curvature. [0026] In another example embodiment of the first aspect, each of the first arm and the second arm are substantially straight. [0027] In another example embodiment of the first aspect, the prosthetic implant further comprises a first channel positioned between the first arm and the second arm. [0028] In another example embodiment of the first aspect, the prosthetic implant further comprises a second channel positioned through at least a portion of the bottom portion. [0029] In another example embodiment of the first aspect, the at least one fixation component is configured to be positioned within a tibia of a patient. [0030] In another example embodiment of the first aspect, a height of the first end of the at least one fixation component is greater than a height of the second end of the at least one fixation component to thereby provide dynamic compression after implantation. [0031] In another example embodiment of the first aspect, the prosthetic implant further comprises one or more modular fixation elements configured to be coupled to the first side of the body. [0032] In a second aspect, a method can include (i) forming a channel in an anterior side of a tibia, and (ii) positioning a cutting surface of a fixation component of a prosthetic implant into the channel, wherein the prosthetic implant includes a body comprising a first side and a second side opposite the first side, wherein the fixation component extends away from the first side, wherein the second side is configured to be coupled to an articulation surface, wherein the fixation component includes a first end and a second end opposite the first end, and wherein the first end of the fixation component includes the cutting surface. [0033] In one example embodiment of the second aspect, the channel does not extend entirely through the tibia. [0034] In another example embodiment of the second aspect, positioning the cutting surface of the fixation component of the prosthetic implant into the channel comprises using one or more impaction instruments. [0035] In another example embodiment of the second aspect, the channel is formed using a sharp broach. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO BRIEF DESCRIPTION OF THE DRAWINGS [0036] Figure 1A provides a front perspective view of an example prosthetic device. [0037] Figure 1B provides a rear view of the example prosthetic device of Figure 1A. [0038] Figure 1C provides a side view of the example prosthetic device of Figure 1A. [0039] Figure 1D provides a rear perspective view of the example prosthetic device of Figure 1A. [0040] Figure 1E provides a front view of the example prosthetic device of Figure 1A. [0041] Figure 1F provides a top view of the example prosthetic device of Figure 1A. [0042] Figure 2A provides a front perspective view of another example prosthetic device. [0043] Figure 2B provides a rear view of the example prosthetic device of Figure 2A. [0044] Figure 2C provides a side view of the example prosthetic device of Figure 2A. [0045] Figure 2D provides a rear perspective view of the example prosthetic device of Figure 2A. [0046] Figure 2E provides a front view of the example prosthetic device of Figure 2A. [0047] Figure 2F provides a top view of the example prosthetic device of Figure 2A. [0048] Figure 3A provides a front perspective view of another example prosthetic device. [0049] Figure 3B provides a rear view of the example prosthetic device of Figure 3A. [0050] Figure 3C provides a side view of the example prosthetic device of Figure 3A. [0051] Figure 3D provides a rear perspective view of the example prosthetic device of Figure 3A. [0052] Figure 3E provides a front view of the example prosthetic device of Figure 3A. [0053] Figure 3F provides a top view of the example prosthetic device of Figure 3A. [0054] Figure 4A provides a front perspective view of another example prosthetic device. [0055] Figure 4B provides a rear view of the example prosthetic device of Figure 4A. [0056] Figure 4C provides a rear perspective view of the example prosthetic device of Figure 4A. [0057] Figure 4D provides a front view of the example prosthetic device of Figure 4A. [0058] Figure 4E provides a top view of the example prosthetic device of Figure 4A. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO [0059] Figure 5A provides a front perspective view of another example prosthetic device. [0060] Figure 5B provides a rear view of the example prosthetic device of Figure 5A. [0061] Figure 5C provides a side view of the example prosthetic device of Figure 5A. [0062] Figure 5D provides a rear perspective view of the example prosthetic device of Figure 5A. [0063] Figure 5E provides a front view of the example prosthetic device of Figure 5A. [0064] Figure 5F provides a top view of the example prosthetic device of Figure 5A. [0065] Figure 6A provides a front perspective view of another example prosthetic device. [0066] Figure 6B provides a rear view of the example prosthetic device of Figure 6A. [0067] Figure 6C provides a side view of the example prosthetic device of Figure 6A. [0068] Figure 6D provides a rear perspective view of the example prosthetic device of Figure 6A. [0069] Figure 6E provides a front view of the example prosthetic device of Figure 6A. [0070] Figure 6F provides a top view of the example prosthetic device of Figure 6A. DETAILED DESCRIPTION [0071] With reference to the Figures, Figures 1A-6F each illustrate various embodiments of a prosthetic implant 100 configured to be positioned within a tibia of a patient. Each of the prosthetic implants 100 of Figures 1A-6F are designed for fixation to a bone (e.g., a tibia or a talus) of a patient using an anterior approach. [0072] As shown in Figures 1A-6F, the prosthetic implant 100 includes a body 102 comprising a first side 104 and a second side 106 opposite the first side 104. The first side 104 comprises a bone contact surface, and the second side 106 is configured to be coupled to an articulation surface. The prosthetic implant 100 further includes at least one fixation component 108 extending away from the first side 104 of the body 102. The at least one fixation component 108 includes a first end 110 and a second end 112 opposite the first end 110, and the first end 110 of the at least one fixation component 108 includes a cutting surface 114. Such a first end with a cutting surface 114 having a lower width may form a sharp cutting edge and allow for better cutting with lower cutting forces. The cutting surface 114 may make the prosthetic implant 100 self-cutting into solid bone material or into a pre-formed groove therein. The first Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO side 104 and the second side 106 may comprise at least essentially flat sections which may at least essentially be parallel to each other. [0073] In an example, the first end 110 of the at least one fixation component 108 has a first width, and the second end 112 of the at least one fixation component 108 has a second width that is greater than the first width. In an example, the body 102 includes a first end 116 and a second end 118 opposite the first end 116, and the first end 110 of the at least one fixation component 108 is offset from the first end 116 of the body 102. This may allow to seat the prosthetic implant 100 in a bone while having a bone wall between the first end 110 of the at least one fixation component 108 and a first end 116 of the body 102 When implanted into a bone, the cutting surface may remain completely within the bone. In one such example, the second end 112 of the at least one fixation component 108 is offset from the second end 118 of the body 102. When implanted into a bone, the fixation component 108 may remain entirely within the bone. In another such example, the second end 112 of the at least one fixation component 108 is aligned with the second end 118 of the body 102. Such an alignment may form an approximately even surface at the second end 112 providing a better contact surface for a mounting tool. [0074] In an example, the body 102 comprises a first material, and the at least one fixation component 108 comprises a second material that is different from the first material. In one such example, the first material comprises titanium, and the second material comprises a nickel-titanium alloy. The superelastic material properties of the nickel-titanium alloy may provide a better fixation in bone. In one example, the prosthetic implant 100 comprises a single-piece design that is 3D printed with a porous structure. In another example, the prosthetic implant 100 comprises a two or three-piece design that is supplied to the user as an assembled system. In another example, prosthetic implant 100 comprises a two or three-piece design that is supplied to the user in parts and is assembled on the back table by a medical professional prior to use. This may allow for a modular design and deliverey of a kit with modular exchangeable parts. [0075] With reference to the Figures, as shown in Figures 1A-1F, in an example the at least one fixation component 108 includes one or more through-holes 120 between the first end 110 and the second end 112. Such through holes may provide a better fixation by screws. As further shown in Figures 1A-1F, in an example the at least one fixation component 108 includes a first side 122 and a second side 124 opposite the first side 122, and the first side 122 and the second side 124 of the at least one fixation component 108 each include a plurality of indents Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO 126 positioned between the first end 110 and the second end 112. The plurality of indents 126 may help prevent removal of the prosthetic implant 100 after implantation. In another example as shown in Figures 1A-1F, the first side 122 and the second side 124 of the at least one fixation component 108 each include a plurality of channels 128 extending from the first end 110 to the second end 112. Such channels 128 may also provide a better locking in the bone and a better bone ingrowth. The channels 128 may have a sawtooth or barb shape to further improve locking. [0076] As shown in Figures 2A-2F, in an example the at least one fixation component 108 includes a bottom portion 130 coupled to the first side 104 of the body 102 and a top portion 132 coupled to the bottom portion 130, where a width of the top portion 132 is greater than a width of the bottom portion 130. Such an enlarged top portion 132 may provide a significant higher retention force, e.g. orthogonal to the second side 106 of the body, holding the implant better in the bone material. In one such example, the top portion 132 includes a first side 136 and a second side 138 opposite the first side 136, and the first side 136 and the second side 138 of the top portion 132 each include a serrated edge, which may further improve fixation in the bone. [0077] As shown in Figures 3A-4F, in an example the at least one fixation component 108 comprises a first fixation component 108A and a second fixation component 108B. The first fixation component 108A includes a first end 110A and a second end 112A opposite the first end 110A, and the first end 110A of the first fixation component 108A comprises a first cutting surface 114A. Similarly, the second fixation component 108B includes a first end 110B and a second end 112B opposite the first end 110B, and the first end 110B of the second fixation component 108B comprises a second cutting surface 114B. The first fixation component 108A and the second fixation component 108B may be mirror-symmetrical with respect to a centerline of the body. They may provide a stronger fixation compared to a single fixation component. [0078] In one such example, as shown in Figures 3A-3F, the first cutting surface 114A and the second cutting surface 114B are serrated, which may improve fixation in the bone. In one example, as shown in Figures 3A-3F, a height of the first end 110A of the first fixation component 108A is less than a height of the second end 112A of the first fixation component 108A, and a height of the first end 110B of the second fixation component 108B is less than a height of the second end 112B of the second fixation component 108B. This may provide a cutting edge for better cutting into the bone. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO [0079] In one example, as shown in Figures 3A-3F, the first fixation component 108A curves towards a centerline of the body 102 with a radius of curvature greater than zero, and the second fixation component 108B curves towards the centerline of the body 102 with the radius of curvature. Such a curvature may provide a higher retention force orthogonal to the second side of the body. [0080] In another example, as shown in Figures 4A-4E, the first fixation component 108A curves away from a centerline of the body 102 with a radius of curvature greater than zero, and the second fixation component 108B curves away from the centerline of the body 102 with the radius of curvature. Also, such a curvature may provide a higher retention force orthogonal to the second side of the body. [0081] In one example, as shown in Figures 5A-6F, a height of the first end 110 of the at least one fixation component 108 is less than a height of the second end 112 of the at least one fixation component 108. This may provide a cutting edge for better cutting into the bone. As further shown in Figures 5A-6F, in one example the at least one fixation component 108 includes a bottom portion 130 coupled to the first side 104 of the body 102 and a top portion 132 coupled to the bottom portion 130. This may provide a higher retention force orthogonal to the second side of the body. In one such example, the top portion 132 includes a first arm 140 extending vertically and laterally away from the bottom portion 130 and a second arm 142 extending vertically and laterally away from the bottom portion 130. As shown in Figures 5A- 5F, in one example the first arm 140 has a radius of curvature greater than zero, and the second arm 140 has the radius of curvature. As shown in Figures 6A-6F, in another example each of the first arm 140 and the second arm 142 are substantially straight. [0082] In an example, as shown in Figures 5A-6F, the prosthetic implant 100 includes a first channel 144 positioned between the first arm 140 and the second arm 142. In another example, as shown in Figures 6A-6F, the prosthetic implant 100 includes a second channel 146 positioned through at least a portion of the bottom portion 130. Such a channel 146 may allow a better fixation by a screw and/or better bone ingrowth. [0083] In an example, if the at least one fixation component 108 is parallel to the body 102, then instrumentation providing an upward/superior force may be required during impaction. In another example, the at least one fixation component 108 may be designed such that the geometry provides a slope allowing for upward pressure to be applied while the prosthetic implant 100 is being impacted. In one such example, a height of the first end 110 of the at least one fixation component 108 is greater than a height of the second end 112 of the at Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO least one fixation component 108 to thereby provide dynamic compression after implantation. Further compression can be achieved by the at least one fixation component 108 bending slightly during impaction, thereby acting like a spring and therefore providing dynamic compression after impact. [0084] In an example, the prosthetic implant 100 includes one or more modular fixation elements configured to be coupled to the first side 104 of the body 102. These one or more modular fixation elements may take the form of pegs, as a non-limiting example. The one or more modular fixation elements may be inserted perpendicular to the body 102, in one example. The one or more modular fixation elements may be self-cutting or press fit, and may further be designed to aid in counter-acting the shear forces in the ankle. [0085] Methods disclosed herein can be used with any of the embodiments of the prosthetic implant 100 as described herein. [0086] A method includes fixing a prosthetic implant to a tibia of a patient. A method can include drilling a channel in a tibia. In an example, the channel does not extend entirely through the tibia. A method can also include positioning a cutting surface of a fixation component of a prosthetic implant into the channel. The prosthetic implant includes a body comprising a first side and a second side opposite the first side. The fixation component extends away from the first side, and the second side is configured to be coupled to an articulation surface. The fixation component includes a first end and a second end opposite the first end, and the first end of the fixation component includes the cutting surface. [0087] In an example, positioning the cutting surface of the fixation component of the prosthetic implant into the channel comprises using one or more impaction instruments. In another example, the channel is formed using a sharp broach. [0088] It should be understood that arrangements described herein are for purposes of example only. As such, those skilled in the art will appreciate that other arrangements and other elements (e.g. machines, interfaces, functions, orders, and groupings of functions, etc.) can be used instead, and some elements may be omitted altogether according to the desired results. Further, many of the elements that are described are functional entities that may be implemented as discrete or distributed components or in conjunction with other components, in any suitable combination and location, or other structural elements described as independent structures may be combined. [0089] While various aspects and examples have been disclosed herein, other aspects and examples will be apparent to those skilled in the art. The various aspects and examples Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope being indicated by the following claims, along with the full scope of equivalents to which such claims are entitled. It is also to be understood that the terminology used herein is for the purpose of describing particular examples only, and is not intended to be limiting. [0090] Example methods and systems are described herein. It should be understood that the words “example,” “exemplary,” and “illustrative” are used herein to mean “serving as an example, instance, or illustration.” Any example or feature described herein as being an “example,” being “exemplary,” or being “illustrative” is not necessarily to be construed as preferred or advantageous over other examples or features. The examples described herein are not meant to be limiting. It will be readily understood that the aspects of the present disclosure, as generally described herein, and illustrated in the figures, can be arranged, substituted, combined, separated, and designed in a wide variety of different configurations, all of which are explicitly contemplated herein. [0091] Furthermore, the particular arrangements shown in the Figures should not be viewed as limiting. It should be understood that other examples may include more or less of each element shown in a given Figure. Further, some of the illustrated elements may be combined or omitted. Yet further, an example may include elements that are not illustrated in the Figures. [0092] In the following description, numerous specific details are set forth to provide a thorough understanding of the disclosed concepts, which may be practiced without some or all of these particulars. In other instances, details of known devices and/or processes have been omitted to avoid unnecessarily obscuring the disclosure. While some concepts will be described in conjunction with specific examples, it will be understood that these examples are not intended to be limiting. [0093] As used herein, “coupled” means associated directly as well as indirectly. For example, a member A may be directly associated with a member B, or may be indirectly associated therewith, e.g., via another member C. It will be understood that not all relationships among the various disclosed elements are necessarily represented. [0094] Unless otherwise indicated, the terms “first,” “second,” etc. are used herein merely as labels, and are not intended to impose ordinal, positional, or hierarchical requirements on the items to which these terms refer. Moreover, reference to, e.g., a “second” item does not require or preclude the existence of, e.g., a “first” or lower-numbered item, and/or, e.g., a “third” or higher-numbered item. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO [0095] Reference herein to “one embodiment” or “one example” means that one or more feature, structure, or characteristic described in connection with the example is included in at least one implementation. The phrases “one embodiment” or “one example” in various places in the specification may or may not be referring to the same example. [0096] As used herein, a system, apparatus, structure, article, element, component, or hardware “configured to” perform a specified function is indeed capable of performing the specified function without any alteration, rather than merely having potential to perform the specified function after further modification. In other words, the system, apparatus, structure, article, element, component, or hardware “configured to” perform a specified function is specifically selected, created, implemented, utilized, programmed, and/or designed for the purpose of performing the specified function. As used herein, “configured to” denotes existing characteristics of a system, apparatus, structure, article, element, component, or hardware which enable the system, apparatus, structure, article, element, component, or hardware to perform the specified function without further modification. For purposes of this disclosure, a system, apparatus, structure, article, element, component, or hardware described as being “configured to” perform a particular function may additionally or alternatively be described as being “adapted to” and/or as being “operative to” perform that function. [0097] The limitations of the following claims are not written in means-plus-function format and are not intended to be interpreted based on 35 U. S. C. § 112(f), unless and until such claim limitations expressly use the phrase “means for” followed by a statement of function void of further structure. [0098] By the term “about,” “approximately,” or “substantially” with reference to amounts or measurement values described herein, it is meant that the recited characteristic, parameter, or value need not be achieved exactly, but that deviations or variations, including for example, tolerances, measurement error, measurement accuracy limitations and other factors known to those of skill in the art, may occur in amounts that do not preclude the effect the characteristic was intended to provide. For example, in one embodiment, the term “about” can refer to ± 5% of a given value. [0099] Illustrative, non-exhaustive examples, which may or may not be claimed, of the subject matter according the present disclosure are provided below.

Claims

Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO CLAIMS What is claimed is: 1. A prosthetic implant comprising: a body comprising a first side and a second side opposite the first side, wherein the first side comprises a bone contact surface, and wherein the second side is configured to be coupled to an articulation surface; and at least one fixation component extending away from the first side of the body, wherein the at least one fixation component includes a first end and a second end opposite the first end, and wherein the first end of the at least one fixation component includes a cutting surface. 2. The prosthetic implant of claim 1, wherein the first end of the at least one fixation component has a first width, and wherein the second end of the at least one fixation component has a second width that is greater than the first width. 3. The prosthetic implant of any one of claims 1-2, wherein the body includes a first end and a second end opposite the first end, and wherein the first end of the at least one fixation component is offset from the first end of the body. 4. The prosthetic implant of claim 3, wherein the second end of the at least one fixation component is offset from the second end of the body. 5. The prosthetic implant of any one of claim 3, wherein the second end of the at least one fixation component is aligned with the second end of the body. 6. The prosthetic implant of any one of claims 1-5, wherein the body comprises a first material, and wherein the at least one fixation component comprises a second material that is different from the first material. 7. The prosthetic implant of claim 6, wherein the first material comprises titanium, and wherein the second material comprises a nickel-titanium alloy. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO 8. The prosthetic implant of any one of claims 1-7, wherein the at least one fixation component includes one or more through-holes between the first end and the second end. 9. The prosthetic implant of any one of claims 1-8, wherein the at least one fixation component includes a first side and a second side opposite the first side, and wherein the first side and the second side of the at least one fixation component each include a plurality of indents positioned between the first end and the second end. 10. The prosthetic implant of any one of claims 1-9, wherein the at least one fixation component includes a first side and a second side opposite the first side, and wherein the first side and the second side of the at least one fixation component each include a plurality of channels extending from the first end to the second end. 11. The prosthetic implant of any one of claims 1-10, wherein the at least one fixation component includes a bottom portion coupled to the first side of the body and a top portion coupled to the bottom portion, and wherein a width of the top portion is greater than a width of the bottom portion. 12. The prosthetic implant of claim 11, wherein the top portion includes a first side and a second side opposite the first side, and wherein the first side and the second side of the top portion each include a serrated edge. 13. The prosthetic implant of any one of claims 1-12, wherein the at least one fixation component comprises a first fixation component and a second fixation component, wherein the first fixation component includes a first end and a second end opposite the first end, wherein the first end of the first fixation component comprises a first cutting surface, wherein the second fixation component includes a first end and a second end opposite the first end, and wherein the first end of the second fixation component comprises a second cutting surface. 14. The prosthetic implant of claim 13, wherein the first cutting surface and the second cutting surface are serrated. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO 15. The prosthetic implant of any one of claims 13-14, wherein a height of the first end of the first fixation component is less than a height of the second end of the first fixation component, and wherein a height of the first end of the second fixation component is less than a height of the second end of the second fixation component. 16. The prosthetic implant of any one of claims 13-15, wherein the first fixation component curves towards a centerline of the body with a radius of curvature greater than zero, and wherein the second fixation component curves towards the centerline of the body with the radius of curvature. 17. The prosthetic implant of any one of claims 13-15, wherein the first fixation component curves away from a centerline of the body with a radius of curvature greater than zero, and wherein the second fixation component curves away from the centerline of the body with the radius of curvature. 18. The prosthetic implant of any one of claims 1-17, wherein a height of the first end of the at least one fixation component is less than a height of the second end of the at least one fixation component. 19. The prosthetic implant of any one of claims 1-18, wherein the at least one fixation component includes a bottom portion coupled to the first side of the body and a top portion coupled to the bottom portion. 20. The prosthetic implant of claim 19, wherein the top portion includes a first arm extending vertically and laterally away from the bottom portion and a second arm extending vertically and laterally away from the bottom portion. 21. The prosthetic implant of claim 20, wherein the first arm has a radius of curvature greater than zero, and wherein the second arm has the radius of curvature. 22. The prosthetic implant of claim 20, wherein each of the first arm and the second arm are substantially straight. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO 23. The prosthetic implant of any one of claims 20-22, further comprising a first channel positioned between the first arm and the second arm. 24. The prosthetic implant of any one of claims 19-23, further comprising a second channel positioned through at least a portion of the bottom portion. 25. The prosthetic implant of any one of claims 1-24, wherein the at least one fixation component is configured to be positioned within a tibia of a patient. 26. The prosthetic implant of any one of claims 1-25, wherein a height of the first end of the at least one fixation component is greater than a height of the second end of the at least one fixation component to thereby provide dynamic compression after implantation. 27. The prosthetic implant of any one of claims 1-26, further comprising: one or more modular fixation elements configured to be coupled to the first side of the body. 28. A method comprising: forming a channel in an anterior side of a tibia; and positioning a cutting surface of a fixation component of a prosthetic implant into the channel, wherein the prosthetic implant includes a body comprising a first side and a second side opposite the first side, wherein the fixation component extends away from the first side, wherein the second side is configured to be coupled to an articulation surface, wherein the fixation component includes a first end and a second end opposite the first end, and wherein the first end of the fixation component includes the cutting surface. 29. The method of claim 28, wherein the channel does not extend entirely through the tibia. 30. The method of any one of claims 28-29, wherein positioning the cutting surface of the fixation component of the prosthetic implant into the channel comprises using one or more impaction instruments. Arthrex 2022-071-DEX-PCT MBHB 22-1986-WO 31. The method of any one of claims 28-30, wherein the channel is formed using a sharp broach.
EP24832823.9A 2023-06-30 2024-06-26 Anterior tibial approach for total ankle replacement Pending EP4719280A1 (en)

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US11540928B2 (en) * 2017-03-03 2023-01-03 Engage Uni Llc Unicompartmental knee arthroplasty
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