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WO2025026774A1 - Prosthetic adapter device - Google Patents

Prosthetic adapter device Download PDF

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Publication number
WO2025026774A1
WO2025026774A1 PCT/EP2024/070628 EP2024070628W WO2025026774A1 WO 2025026774 A1 WO2025026774 A1 WO 2025026774A1 EP 2024070628 W EP2024070628 W EP 2024070628W WO 2025026774 A1 WO2025026774 A1 WO 2025026774A1
Authority
WO
WIPO (PCT)
Prior art keywords
adapter
implant component
tibial implant
protrusion
knee prosthesis
Prior art date
Application number
PCT/EP2024/070628
Other languages
French (fr)
Inventor
Klaus Dmuschewsky
Marco Iredi
Dario LUPO
Original Assignee
Waldemar Link Gmbh & Co. Kg
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 Waldemar Link Gmbh & Co. Kg filed Critical Waldemar Link Gmbh & Co. Kg
Publication of WO2025026774A1 publication Critical patent/WO2025026774A1/en

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
    • A61F2/38Joints for elbows or knees
    • A61F2/389Tibial 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
    • 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
    • A61F2/38Joints for elbows or knees
    • A61F2/3859Femoral components

Definitions

  • knee prostheses are used in orthopedic surgeries to replace damaged or diseased knee joints and/or portions thereof.
  • the prostheses are designed to mimic the shape and function of a natural knee joint.
  • Knee prostheses are commonly used to treat various conditions that cause joint pain and stiffness, such as osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis.
  • the replacement surgery for implanting the knee prostheses into a patient involves removing the damaged entirety, or portion thereof, of the knee joint and replacing it with a prosthesis.
  • Knee implants can significantly improve mobility and quality of life for patients with knee pain.
  • knee implant surgery carries certain risks and complications, such as infection, blood clots, and implant failure. Thus, it can occur that after implantation, a portion of a knee prosthesis must be replaced.
  • the tibial sided component must be replaced on a patient.
  • this replacement procedure would require removal of both the femoral component as well as the tibial component, so that the replaced tibial sided component would mate and operate with the femoral component, as these components are designed to complement each other in size/shape and degree of freedom.
  • an adapter configured for use with a knee prosthesis.
  • the adapter comprising an upper surface configured to contact a portion of a femur implant, wherein the upper surface comprises a protrusion, a distal end of the protrusion being a distance away from the upper surface; a lower surface configured to contact a portion of a lower leg implant, the lower surface opposite the upper surface; and at least one opening that extends from the upper surface to the lower surface.
  • FIG. 1 is an image of a knee prosthesis system, in a separated configuration, of an embodiment of the present disclosure
  • FIG. 4 is an underside perspective view of an adapter of an embodiment of the present disclosure
  • FIG. 5 is a side view of an adapter of an embodiment of the present disclosure.
  • FIG. 6 is a cross-sectional and side view of an adapter, a spacer and a tibial implant component, in a secured configuration, of an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE DISCLOSURE
  • the term “substantially” or “substantial”, is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result.
  • a surface that is “substantially” flat would either be completely at, or so nearly flat that the effect would be the same as if it were completely flat.
  • each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters describing the broad scope of the disclosure are approximations, the numerical values in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains standard deviations that necessarily result from the errors found in the numerical value's testing measurements.
  • any numerical range expressly includes each numerical value (including fractional numbers and whole numbers) encompassed by that range.
  • reference herein to a range of “at least 50” or “at least about 50” includes whole numbers of 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, etc., and fractional numbers 50.1, 50.2 50.3, 50.4, 50.5, 50.6, 50.7, 50.8, 50.9, etc.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (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 includes a knee prosthesis system. The system includes an adapter, the adapter including a lower surface and an upper surface, the lower surface opposite the upper surface, the lower surface configured to contact a tibial implant component or a femur implant component, the upper surface comprising a protrusion, wherein a distal end of the protrusion is a distance away from the upper surface, wherein the adapter is configured to attach to the tibial implant component or the femur implant component.

Description

PROSTHETIC ADAPTER DEVICE
[0001] This application claims the benefit and priority from United States Provisional Patent Application No. 63/517,218, filed August 2, 2023; the disclosure of which is incorporated herein by reference in its entirety.
BACKGROUND OF THE DISCLOSURE
[0002] Various knee prostheses are used in orthopedic surgeries to replace damaged or diseased knee joints and/or portions thereof. The prostheses are designed to mimic the shape and function of a natural knee joint. Knee prostheses are commonly used to treat various conditions that cause joint pain and stiffness, such as osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis. The replacement surgery for implanting the knee prostheses into a patient involves removing the damaged entirety, or portion thereof, of the knee joint and replacing it with a prosthesis.
[0003] Knee implants can significantly improve mobility and quality of life for patients with knee pain. However, like any surgical procedure, knee implant surgery carries certain risks and complications, such as infection, blood clots, and implant failure. Thus, it can occur that after implantation, a portion of a knee prosthesis must be replaced.
[0004] For example, the tibial sided component must be replaced on a patient. Typically, this replacement procedure would require removal of both the femoral component as well as the tibial component, so that the replaced tibial sided component would mate and operate with the femoral component, as these components are designed to complement each other in size/shape and degree of freedom.
[0005] Knee prostheses are known whose femoral and tibial components have different degrees of freedom relative to one another. The less the residual stability of the knee to be fitted with the prosthesis, the greater the stability that the prosthesis must provide and the smaller the number of degrees of freedom that can be given to the relative movement between the two components, and vice versa. The restriction on the degrees of freedom is achieved by a coupling device which acts between the femoral component and the tibial component.
[0006] The femoral component, tibial component and coupling device all complement each other and can be limited in operability to each other. Thus, if any component is to be replaced, all must be, which leads to a greater surgical procedure and removal of otherwise satisfactory components. [0007] Therefore, what is desired is a device to operate as an adapter between any design of femoral component and any design of tibial component, so that is one component is to be replaced, the other component can remain implanted.
SUMMARY OF THE DISCLOSURE
[0008] In accordance with one or more embodiments, devices and methods are provided.
[0009] In one embodiment an adapter is provided that is configured for use with a knee prosthesis. The adapter comprising an upper surface configured to contact a portion of a femur implant, wherein the upper surface comprises a protrusion, a distal end of the protrusion being a distance away from the upper surface; a lower surface configured to contact a portion of a lower leg implant, the lower surface opposite the upper surface; and at least one opening that extends from the upper surface to the lower surface.
[0010] The disclosure further relates to a method for producing, and a method of implanting, an adapter of the present disclosure.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure, and, together with the summary given above, and the detailed description of the embodiments below, serve as a further explanation and disclosure to explain and/or illustrate embodiments of the disclosure.
[0012] FIG. 1 is an image of a knee prosthesis system, in a separated configuration, of an embodiment of the present disclosure;
[0013] FIG. 2 is a perspective view of an adapter of an embodiment of the present disclosure;
[0014] FIG. 3 is a perspective view of an adapter of an embodiment of the present disclosure;
[0015] FIG. 4 is an underside perspective view of an adapter of an embodiment of the present disclosure;
[0016] FIG. 5 is a side view of an adapter of an embodiment of the present disclosure; and
[0017] FIG. 6 is a cross-sectional and side view of an adapter, a spacer and a tibial implant component, in a secured configuration, of an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE DISCLOSURE
[0018] It is noted that the drawings of the present application are provided for illustrative purposes only and, as such, the drawings are not drawn to scale. It is also noted that like and corresponding elements are referred to by like reference numerals.
[0019] In the following description, numerous specific details are set forth, such as particular structures, components, materials, dimensions, processing steps and techniques, in order to provide an understanding of the various embodiments of the present application. However, it will be appreciated by one of ordinary skill in the art that various embodiments of the present application may be practiced without these specific details. In other instances, well-known structures or processing steps have not been described in detail in order to avoid obscuring the present application.
[0020] As used herein, the term “substantially” or “substantial”, is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result. For example, a surface that is “substantially” flat would either be completely at, or so nearly flat that the effect would be the same as if it were completely flat.
[0021] As used herein, terms defined in the singular are intended to include those terms defined in the plural and vice versa.
[0022] As used in this specification and its appended claims, terms such as “a”, “an” and “the” are not intended to refer to only a singular entity but include the general class of which a specific example may be used for illustration, unless the context dictates otherwise. The terminology herein is used to describe specific embodiments of the disclosure, but their usage does not delimit the disclosure, except as outlined in the claims. [0023] Unless otherwise indicated, all numbers expressing quantities of ingredients, properties such as molecular weights, reaction conditions, and so forth as used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters in the specification and claims are approximations that may vary depending upon the desired properties sought to be obtained by the present disclosure. At the very least, and without limiting the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters describing the broad scope of the disclosure are approximations, the numerical values in the specific examples are reported as precisely as possible. Any numerical value, however, inherently contains standard deviations that necessarily result from the errors found in the numerical value's testing measurements.
[0024] Thus, reference herein to any numerical range expressly includes each numerical value (including fractional numbers and whole numbers) encompassed by that range. To illustrate, reference herein to a range of “at least 50” or “at least about 50” includes whole numbers of 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, etc., and fractional numbers 50.1, 50.2 50.3, 50.4, 50.5, 50.6, 50.7, 50.8, 50.9, etc. In a further illustration, reference herein to a range of “less than 50” or “less than about 50” includes whole numbers 49, 48, 47, 46, 45, 44, 43, 42, 41, 40, etc., and fractional numbers 49.9, 49.8, 49.7, 49.6, 49.5, 49.4, 49.3, 49.2, 49.1, 49.0, etc. In yet another illustration, reference herein to a range of from “5 to 10” includes whole numbers of 5, 6, 7, 8, 9, and 10, and fractional numbers 5.1, 5.2, 5.3, 5,4, 5,5, 5.6, 5.7, 5.8, 5.9, etc.
[0025] In the discussion and claims herein, the tern “about” indicates that the value listed may be somewhat altered, as long as the alteration does not result in nonconformance of the process or structure to the illustrated embodiment. For example, for some elements the term “about” can refer to a variation of ±0.1%, for other elements, the term “about” can refer to a variation of ±1% or ±10%, or any point therein.
[0026] Reference now will be made in detail to embodiments of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the disclosure. For instance, features illustrated or described as part of one embodiment can be used on another embodiment to yield a still further embodiment.
[0027] An embodiment of an adapter of the present disclosure is shown in FIG. 1, in a separated configuration. FIG. 1 includes a femur implant component 2 of a knee prosthesis 100. This femur implant component 2 can be any suitable femur implant component, or a portion thereof, that is configured to be implanted into a patient’s femur, from any manufacturer. The knee prosthesis 100 also include a tibial implant component 4. This tibial implant component 4 can be any suitable tibial implant component, or a portion thereof, that is configured to be implanted into a patient’s lower leg and/or tibia, from any manufacturer.
[0028] Between the femur implant component 2 and the tibial implant component 4 a spacer 6 can be included in the knee prosthesis 100. The spacer 6 can be formed of any suitable material, such as a biocompatible material, metal(s), ceramic(s), carbon based material(s), plastic(s), etc., and combinations thereof. The spacer 6 can be any suitable shape, from any suitable manufacturer, and can be secured to the femur implant component 2 or the tibial implant component 4 with a fixation device 8 through any one or more suitable openings. The fixation device 8 can be any suitable device able to maintain the spacer 6 in contact with the femur implant component 2 or the tibial implant component 4, such as a screw, clip, a rivet, a press fit connecter, a nail, a peg, a bolt, or any other suitable fastener and/or an adhesive.
[0029] An adapter 10 is included as a component of the knee prosthesis 100. In this embodiment, the adapter 10 is configured to be fixed and/or attached to the tibial implant component 4, by at least one fixation device 12, however, in other embodiments, the adapter 10 can be configured to be fixed and/or attached to the femur implant component 2. The adapter 10 can be formed of any suitable material, such as a biocompatible material, metal(s), ceramic(s), carbon based material(s), plastic(s), etc., and combinations thereof.
[0030] As used herein, the term “biocompatible” or “biocompatible material” refers to any material which upon implantation into a mammal’s body that does not elicit a substantial detrimental response in vivo, and/or a material exhibiting essentially no cytotoxicity or immunogenicity while in contact with body fluids, tissues and/or bones. For example, the biocompatible material can be selected from the group consisting of titanium (of any grade), Nitinol®, steel, surgical steel, calcium, copper, zinc, iron, cobalt, magnesium, manganese, vanadium, molybdenum, silicate, strontium, tungsten, chromium, nickel, aluminum, and ceramics, composites, alloys (such as TiA16V4), compounds, and mixtures thereof.
[0031] In FIG. 1, if the femur implant component 2 is first implanted into a patient and is later to be removed, the tibial implant component 4 could remain implanted during the procedure. The procedure would include removal of the previously implanted femur implant component, if a pervious adapter was present, removal of that adapter, selection of a to be implanted femur implant component 2, and then selection of the adapter 10. The adapter 10 would include appropriately sized and placed opening(s) to connect the adapter 10 to one of the replacing femur implant component 2 and the tibial implant component 4, an appropriately sized and shaped perimeter 24 to substantially coordinate with a distal end 5 of the femur implant component 2, or to substantially coordinate with a proximal end 3 of the tibial implant component 4, specifically an upper surface 7 of the proximal end 3 of the tibial implant component 4. The adapter 10 also includes a protrusion to coordinate with the proximal end 3 of the tibial implant component 4, or to coordinate with the distal end 5 of the femur implant component 2. [0032] A more details view of the adapter 10 is shown in FIG. 2, which a perspective view of an upper surface 14 of the adapter 10. The upper surface 14 of the adapter 10 is configured to contact a portion of the femur implant component (2 of FIG. 1) (or contact an intermediary material between the adapter 10 and the femur implant 2, such as a spacer). The upper surface 14 includes a protrusion 16 that is either integral with the rest of the adapter 10, or is fixed to the adapter 10, with a distal end 18 of the adapter 10 being a distance away from the upper surface 14. The size and/or shape of the protrusion 16 can be configured to correspond to a cavity of the distal end 5 of the femur implant component 2, or the protrusion 16 can be configured to correspond to a cavity of the proximal end 3 of the tibial implant component 4, depending on which implant component the adapter 10 is fixed.
[0033] In FIG. 2, three openings 20 are shown, with each opening 20 extending from the upper surface 14 to the lower surface (seen in FIG. 4). Each of the openings 20 is sized and located on the adapter 10 in locations that correspond to locations of fixation on the corresponding implant component. Each of the openings 20 can be smooth or substantially smooth, and/or each of the openings may have grooves, ridges, and/or threads that are configured to accept a screw’s thread.
[0034] The upper surface 14 also can include, optionally, an indentation 22 that is configured to correspond to the shape of a corresponding protrusion of the spacer 6.
[0035] In the embodiment of FIG. 2, the protrusion 16 is in the shape that allows for a degree of yaw/axial rotation between the tibial implant component 4 and the femur implant component 2. In other embodiments, the protrusion 16 can be configured into other shapes based on the desired movements of the knee prosthesis 100.
[0036] As one example of another embodiment wherein the protrusion is a different shape, an adapter 10’ including a protrusion 16’ is shown in FIG. 3. This protrusion 16’ can be referred to as a “hinge” type protrusion to correspond to the distal end 5 of the femur implant component 2, or the protrusion 16’ can be configured to correspond to the proximal end 3 of the tibial implant component 4, depending on which implant component the adapter 10 is fixed. Protrusion 16’ is configured to limit or eliminate yaw/axial rotation between the tibial implant component 4 and the femur implant component 2.
[0037] Rather than extend into a corresponding cavity, as protrusion 16 is configured to do, protrusion 16’ is configured with a transverse opening 21, through which a pin or the like can extend through, along with extending through the distal end 5 of the femur implant component 2, or the proximal end 3 of the tibial implant component 4, depending on which implant component the adapter 10 is fixed, so that the femur implant component 2 and the tibial implant component 4 can rotate relative to each other along the axis of the transverse opening 21. Other shapes and configurations of the protrusion may be included in other embodiments, as desired and/or as intended based on various design outcomes.
[0038] A view of the lower surface 26 of another embodiment of an adapter 10” is shown in FIG. 4. The lower surface 26 of the adapter 10” is configured to contact either a portion of the tibial implant component 4 (or contact an intermediary material between the adapter 10” and the tibial implant component 4, such as a spacer) or a portion of the femur implant component 2 (or contact an intermediary material between the adapter 10” and the tibial implant component 2, such as a spacer). In this embodiment, perimeter 24’ is not ovular and includes an indentation 25, as an example of the different shapes adapter 10” can be. In other embodiments, the adapter could include two or more indents of differing sizes and shapes as desired and/or as intended based on various design outcomes.
[0039] A side view of the adapter 10 is shown in FIG. 5. In some embodiments a plane of the upper surface 14 and a plane of the lower surface 26 are parallel or substantially parallel. In other embodiments, such as the one shown in FIG. 5, the plane of the upper surface 14 and the plane of the lower surface 26 are at an angle 0 to one another and intersect. 9 can be any suitable angle within any suitable range, such as about 0.01° to about 45°, about 0.1° to about 30°, about 0.2° to about 20°, about 0.3° to about 10°, about 0.5° to about 8°, about 1° to about 5 °, about 2°, about 3°, or about 4°, and all points within any of these ranges.
[0040] In the embodiment of FIG. 5, the angle between the plane of the upper surface 14 and the plane of the lower surface 26 is such that on a side of the adapter 10 further from the location of the protrusion 16 the planes are angled toward each other. In other embodiments, the angle is in the opposite direction (opposite direction from what is shown in FIG. 5), from the side of the adapter 10 furthest from the location of the protrusion 16, towards the protrusion 16. In other embodiments, the plane of the upper surface 14 and the plane of the lower surface 26 are angled towards each other along any other point along the perimeter 24 of the adapter 10.
[0041] FIG. 6 is a partial cross-sectional view of the adapter 10 in a secured configuration with the tibial implant component 4, with the adapter 10 between the spacer 6 and the tibial implant component 4. In other embodiments, the adapter 10 can be in a secured configuration with the femur implant component 2. In FIG. 6, the hatched areas are cross sectional-views, while the un-hatched areas are a side view. As seen in FIG. 6, a tibial post 28 is included with tibial implant component 4, which is representative of all structures extending away from the tibial implant component 4 to provide support between the prosthesis and the lower leg bone(s).
[0042] The adapter 10 and the tibial implant component 4 are maintained in the secured configuration of FIG. 6 by the fixation device 8 and the fixation device 12. In this embodiment both the fixation device 8 and the fixation device 12 are screws.
[0043] To supplement connection between the adapter 10 and the tibial implant component 4, a lower portion of the adapter 10 can include a lower protrusion 32, which can extend between the adapter 10 and a lower extension 30 of the tibial implant component 4 and reduce and/or eliminate vertical (up to down direction of FIG. 6) separation between the adapter 10 and the tibial implant component 4.
[0044] To supplement connection between the adapter 10 and the spacer 6, the adapter 10 can also include an upper protrusion 34 which can extend between the adapter 10 and an extension 36 of the spacer 6, and reduce and/or eliminate vertical separation between the adapter 10 and the spacer 6.
[0045] The spacer 6 can also include a spacer abutment 39 that is configured to contact or nearly contact an upper adapter abutment 41 of the adapter 10 to reduce and/or eliminate horizontal movement (left to right direction of FIG. 6) between the adapter 10 and the tibial implant component 4.
[0046] The adapter 10 can also include a lower adapter abutment 38 that is configured to contact or nearly contact a tibial implant abutment 40. The lower adapter abutment 38 is configured to reduce and/or eliminate horizontal movement (left to right direction of FIG. 6) between the adapter 10 and the spacer 6.
[0047] The fixation device 12 can be configured with a fixation bevel edge 42 that is configured to interact with an adapter bevel edge 44. This contact between the fixation bevel edge 42 and the adapter bevel edge 44 can provide both some flexibility in placement of the adapter 10 relative to the tibial implant component 4, and a relatively secure joint caused by the inclined interaction between the fixation bevel edge 42 and the adapter bevel edge 44. For example, the inclined interaction caused by the movement of the fixation bevel edge 42 in the downward direction of FIG. 6 causes the fixation bevel edge 42 to contact the adapter bevel edge 44 and cause the adapter 10 to move in the right (horizontal) direction of FIG. 6 (in this example the movement is in the right direction, but in other embodiments and configurations, the movement can be in any suitable direction). This right direction movement thus presses the lower protrusion 32 into the space between the tibial implant component 4 and the lower extension 30. Such movement in the right direction creates a fixation gap 46 between the fixation bevel edge 42 and the adapter bevel edge 44.
[0048] These features of the interaction between the fixation bevel edge 42 and the adapter bevel edge 44, as well as the other structural features of the tibial implant component 4, the spacer 6 and the adapter 10 interacting with each other can also reduce micromovements between the components, which can cause abrasions and potentially loosening of the components.
[0049] The present disclosure also includes methods of implanting disclosed embodiments of the knee prosthesis system 100, methods of removing from an implanted state, one of the femur implant component 2 or the tibial implant component 4 of embodiments of the knee prosthesis system 100, and methods of assembling, in situ or ex situ, embodiments of the knee prosthesis system 100.
[0050] In one embodiment the knee prosthesis system 100 can be implanted into a patient. The method for implantation can include inserting the tibial implant component 4 into a tibial implant implanted location of the patient’s tibia. Then, a lower protrusion 32 of the adapter 10 can be moved into a space between a lower extension 30 of the tibial implant component 4 and the tibial implant component 4. Next, the adapter 10 can be fixed to the tibial implant component 4 with any suitable fixation device, such as fixation device 12. After fixation, the spacer 6 can be moved into contact with the adapter 10 and then be fixed to the adapter 10 with any suitable fixation device, such as fixation device 8. Then, the protrusion 16 can be moved into contact with a portion of the femur implant component 2.
[0051] In this method of implantation, the knee prosthesis system 100 can include a fixation device, such as the fixation device 12, which can comprise a fixation bevel edge 42. The adapter 10 of the knee prosthesis system 100 can include an adapter bevel edge 44. Thus, the method of implanting can include fixing the adapter 10 to the tibial implant component 4 with the fixation device 12, which can cause the adapter 10 to move in a horizontal direction (left to right direction of FIG. 6) relative to the tibial implant component 4.
[0052] Another embodiment of the disclosure includes a method of removing, from an implanted state, one of the femur implant component 2 or the tibial implant component 4. In this embodiment, just one of the femur implant component 2 or the tibial implant component 4 needs to be replaced during a procedure, so that the non-replaced component can remain implanted, with a new femur implant component or tibial implant component implanted thereafter. In this subsequent implantation, the same adapter 10 can be used if it is the correct size and shape, a new adapter 10 of the same size and shape can be used, or a differently sized and/or shaped adapter can be included.
[0053] This method includes a step a) of moving the protrusion 16 of the adapter 10 from contacting a portion of the femur implant component 2, followed by step b) of removing a fixation device, such as fixation device 8. Then in step c) moving the spacer 6 from contacting a portion of the adapter 10, followed by step d) of removing a fixation device, such as fixation device 12. Next, in step e) the method includes moving a lower protrusion 32 of the adapter 10 out of a space between a lower extension 30 of the tibial implant component 4 and the tibial implant component 4 and then in step f), moving the adapter 10 from contacting a portion of the tibial implant component 4.
[0054] Depending on which one of the femur implant component 2 or the tibial implant component 4 is to be removed and replaced, either between steps a. and b., the method can further include removing from the implanted state, the femur implant component 2, or the method can include, after step f., removing from the implanted state, the tibial implant component 4.
[0055] After this removal, the method can further include implanting either an alternative femur implant or an alternative tibia implant, and moving an alternative adapter that is differently sized and/or shaped as compared to adapter 10, or the same adapter 10, or a new adapter 10 of the same size and shape or a differently sized and/or shaped adapter can be included into contact with the portion of the tibial implant component 4. The alternative adapter that is differently sized and/or shaped as compared to adapter 10 can be any suitable size and/or shape to compensate for the difference in size and or shape of the newly implanted, alternative femur implant or alternative tibia implant.
[0056] Another embodiment of the disclosure includes a method of assembling a knee prosthesis system 100. This assembly can occur either, in situ at the site of implantation or ex situ in any suitable location, such as in a surgical theater.
[0057] This method of assembly includes moving a lower protrusion 32 of the adapter 10 into a space between a lower extension 30 of the tibial implant component 4 and the tibial implant component 4, followed by fixing the adapter 10 to the tibial implant component 4 with a suitable fixation device, such as fixation device. Next in the method, the spacer 6 is moved into contact with the adapter 10, the spacer 6 is fixed to the adapter 10 with any suitable fixation device, such as fixation device 8 and then the protrusion 16 of the adapter 10 is moved into contact with a portion of the femur implant component 2.
[0058] The described embodiments and examples of the present disclosure are intended to be illustrative rather than restrictive and are not intended to represent every embodiment or example of the present disclosure. While the fundamental novel features of the disclosure as applied to various specific embodiments thereof have been shown, described and pointed out, it will also be understood that various omissions, substitutions and changes in the form and details of the devices illustrated and, in their operation, may be made by those skilled in the art without departing from the spirit of the disclosure. For example, it is expressly intended that all combinations of those elements and/or method steps which perform substantially the same function in substantially the same way to achieve the same results are within the scope of the disclosure. Moreover, it should be recognized that structures and/or elements and/or method steps shown and/or described in connection with any disclosed form or embodiment of the disclosure may be incorporated in any other disclosed or described or suggested form or embodiment as a general matter of design choice. Further, various modifications and variations can be made without departing from the spirit or scope of the disclosure as set forth in the following claims both literally and in equivalents recognized in law.

Claims

1. A knee prosthesis system, the system comprising: an adapter, the adapter comprising a lower surface and an upper surface, the lower surface opposite the upper surface, the lower surface configured to contact a tibial implant component or a femur implant component, the upper surface comprising a protrusion, wherein a distal end of the protrusion is a distance away from the upper surface, wherein the adapter is configured to attach to the tibial implant component or the femur implant component.
2. The knee prosthesis system of claim 1, further comprising a spacer that is configured to contact a femur implant component, wherein the spacer is configured to attach to the adapter.
3. The knee prosthesis system of any one of the preceding claims, wherein the adapter comprises one or more openings that are configured to correspond to locations of fixation on one or both of the femur implant component and the tibial implant component.
4. The knee prosthesis system of any one of the preceding claims, wherein the protrusion is configured to correspond to a cavity of a distal end of the tibial implant component or to correspond to a cavity of a proximal end of the femur implant component.
5. The knee prosthesis system of any one of the preceding claims combined with claim 2, wherein the upper surface of the adapter comprises an indentation that is configured to correspond to a shape of a portion of the spacer.
6. The knee prosthesis system of any one of the preceding claims, wherein the protrusion is configured for yaw/axial rotation between the tibial implant component and the femur implant component.
7. The knee prosthesis system of any one of the preceding claims, further comprising a pin, wherein the protrusion comprises a transverse opening, wherein the pin is configured to extend through both the transverse opening and one of the distal end of the tibial implant component, or a proximal end of the femur implant component.
8. The knee prosthesis system of claim 7, wherein the protrusion is configured to limit or eliminate yaw/axial rotation between the tibial implant component and the femur implant component.
9. The knee prosthesis system of any one of the preceding claims, wherein a plane of the upper surface and a plane of a lower surface of the adapter are parallel or substantially parallel.
10. The knee prosthesis system of any one of the preceding claims, wherein a plane of the upper surface and a plane of a lower surface of the adapter are at an angle 9 to one another and intersect, wherein the angle 9 is about 0.2° to about 20°.
11. The knee prosthesis system of any one of the preceding claims, wherein the adapter comprises a lower protrusion, wherein the tibial implant component comprises a lower extension a distance from the upper surface of the tibial implant component, wherein lower protrusion extends into a space between an upper surface of the tibial implant component and the lower extension in a secured configuration.
12. The knee prosthesis system of any one of the preceding claims combined with claim 2, wherein the adapter further comprises an upper protrusion, wherein the spacer comprises an extension, and wherein the upper protrusion extends between the adapter and the extension of the spacer, in a secured configuration.
13. The knee prosthesis system of any one of the preceding claims combined with claim 2, further comprising a fixation device, wherein the fixation device comprises a fixation bevel edge, wherein the adapter further comprises an adapter bevel edge, and wherein the fixation bevel edge is configured to contact the adapter bevel edge in a secured configuration.
14. The knee prosthesis system of claim 13, wherein in the secured configuration, a fixation gap is formed between the fixation bevel edge and the adapter bevel edge.
15. The knee prosthesis system of any one of the preceding claims, wherein the adapter further comprises a lower adapter abutment, the tibial implant component further comprises a tibial implant abutment, wherein the lower adapter abutment is configured to contact or nearly contact the tibial implant abutment in a secured configuration.
16. Method of implanting the knee prosthesis system of any one of the preceding claims combined with claim 2, the method comprising: inserting the tibial implant component into a tibial implant implanted location; moving a lower protrusion of the adapter into a space between a lower extension of the tibial implant component and the tibial implant component; fixing the adapter to the tibial implant component with a fixation device; moving the spacer into contact with the adapter; fixing the spacer to the adapter with a fixation device; and moving the protrusion into contact with a portion of the femur implant component.
17. The method of claim 16, wherein the fixation device comprises a fixation bevel edge , wherein the adapter further comprises an adapter bevel edge, wherein fixing the adapter to the tibial implant component with the fixation device moves the adapter in a horizontal direction relative to the tibial implant component.
18. Method of removing, from an implanted state, one of the femur implant component or the tibial implant component of any one of the preceding claims combined with claim 2, the method comprising: a. moving the protrusion from contacting a portion of the femur implant component; b. removing a fixation device; c. moving the spacer from contacting a portion of the adapter; d. removing a fixation device; e. moving a lower protrusion of the adapter out of a space between a lower extension of the tibial implant component and the tibial implant component; and f. moving the adapter from contacting a portion of the tibial implant component.
19. The method of claim 18, further comprising between steps a. and b., removing from the implanted state, the femur implant, or, after step f., removing from the implanted state, the tibial implant component.
20. The method of claim 19, further comprising implanting either an alternative femur implant or an alternative tibia implant and moving an alternative adapter to contact the portion of the tibial implant component.
PCT/EP2024/070628 2023-08-02 2024-07-19 Prosthetic adapter device WO2025026774A1 (en)

Applications Claiming Priority (2)

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US202363517218P 2023-08-02 2023-08-02
US63/517,218 2023-08-02

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160374814A1 (en) * 2010-07-30 2016-12-29 Howmedica Osteonics Corp. Stabilized knee prosthesis
US20180125667A1 (en) * 2016-11-07 2018-05-10 John Bodeker Savage Prosthetic apparatus and systems for total knee arthroplasty
US20190091030A1 (en) * 2017-09-26 2019-03-28 Stephen J. Incavo Knee arthroplasty with modular femoral adapters
US20200368030A1 (en) * 2018-05-02 2020-11-26 Depuy Ireland Unlimited Company Orthopaedic prosthetic system for a hinged-knee prosthesis

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160374814A1 (en) * 2010-07-30 2016-12-29 Howmedica Osteonics Corp. Stabilized knee prosthesis
US20180125667A1 (en) * 2016-11-07 2018-05-10 John Bodeker Savage Prosthetic apparatus and systems for total knee arthroplasty
US20190091030A1 (en) * 2017-09-26 2019-03-28 Stephen J. Incavo Knee arthroplasty with modular femoral adapters
US20200368030A1 (en) * 2018-05-02 2020-11-26 Depuy Ireland Unlimited Company Orthopaedic prosthetic system for a hinged-knee prosthesis

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