Insert for locking screw adaptation

Abstract

A surgical implant aperture insert for use in a surgical implant system; and a surgical implant system for use in arthroplasty, the surgical implant system comprising an aperture and a surgical implant aperture insert. The insert increases the surface area of a surgical component that can be used for bone regrowth, and a mating component may be provided to allow for use of different fixtures within the aperture.

Description

[0001] Cross-referencing

[0002] This application relates to a currently unknown co-pending application serial number entitled "Insert for Setting Cement Mantle Thickness" filed on the same date with the same applicant at the same patent office. These applications and the resulting patents are incorporated herein by reference, including their specifications and drawings. Technical Field

[0003] This specification relates to an insert for positioning within a screw hole of a surgical device. More particularly, it relates to an insert for adapting a screw hole suitable for a non-locking screw to a screw hole suitable for a locking screw. This disclosure also relates to a kit comprising at least two implants of this disclosure. This disclosure further relates to a method for adapting a screw hole suitable for a non-locking screw to a screw hole suitable for a locking screw during surgery. Background Technology

[0004] Arthroplasty is a well-known surgical procedure that replaces a diseased and / or damaged natural joint with a prosthetic joint. For example, in hip arthroplasty, a patient's natural hip joint is partially or completely replaced by an artificial hip prosthesis.

[0005] Sometimes revision hip arthroplasty is necessary. In such revision surgeries, the previously implanted hip prosthesis is surgically removed and a replacement hip prosthesis is implanted. In some revision surgeries, all components of the previously implanted hip prosthesis may be surgically removed, including, for example, the femoral stem, neck component, and acetabular cup. In other revision surgeries, only a portion of the previously implanted hip prosthesis may be removed and replaced.

[0006] The placement of locking screws and non-locking screws in surgical implants depends on the type and location of the implant and whether the surgery is a revision.

[0007] Typically, implants such as acetabular shells only provide screw holes for non-locking screws. This means that even if a surgeon prefers to use locking screws, the provided implant may not be usable. This is because locking and non-locking screws are sized differently. Locking screw holes are generally smaller and have tighter tolerances than non-locking screw holes.

[0008] The acetabular shell and other types of surgical implants used during revision surgery typically contain multiple different screw holes, allowing the surgeon to select the location with the most suitable bone. Surgeons do not usually place screws in every available screw hole. The total surface area of ​​a surgical implant that promotes bone ingrowth is reduced by the number of screw holes present. SUMMARY

[0009] According to a first aspect of the present disclosure, there is provided a surgical implant system, the system comprising:

[0010] one or more surgical implants, at least one of the surgical implants having a distal surface and a proximal surface, a surgical implant aperture extending between the distal surface and the proximal surface;

[0011] one or more surgical fixations; and

[0012] one or more surgical implant aperture inserts;

[0013] wherein at least one of the surgical implant aperture inserts comprises:

[0014] a body portion providing a distal surface and a proximal surface, the body portion further providing an intermediate surface extending between the distal surface and the proximal surface;

[0015] a through-hole extending between the distal surface and the proximal surface, the through-hole being defined by a through-hole surface;

[0016] wherein the intermediate surface comprises a surgical implant aperture contact portion;

[0017] wherein the through-hole surface comprises a surgical fixation contact portion.

[0018] The surgical implant aperture insert can further comprise, wherein the intermediate surface defines a first cross-sectional profile in a plane, wherein the through-hole surface defines a second cross-sectional profile in the plane, and wherein the second profile is within the first profile.

[0019] The surgical implant can be an orthopaedic implant. The surgical implant can be one or more of: an acetabular shell; a partial acetabular shell; an acetabular cage; a femoral implant. The surgical implant can be a trauma treatment implant, such as a trauma plate.

[0020] The surgical implant can be provided with an aperture surface provided with one or more insert retaining elements.

[0021] The surgical implant can be provided with one or more insert retaining elements that are male retaining elements and / or female retaining elements, for example adapted to engage with complementary elements provided on the insert, for example on an intermediate surface of the insert. The surgical implant can be provided with a plurality of radially recessed female retaining elements, such as grooves or recesses.

[0022] The surgical implant, for example the surgical implant aperture thereof, can be provided with threaded insert retaining elements.

[0023] The surgical kit can comprise two or more surgical fixings comprising at least one first type of fixing and at least one second type of fixing. For example, one or more screw fixings can be provided comprising one or more non-locking fixings as the first type and / or one or more lockable fixings as the second type.

[0024] The first type of fixing can differ from the second type of fixing in one or more characteristics of the threaded portion of the fixing. The one or more characteristics can be selected from: handedness; form; angle; lead; pitch; start; major diameter; minor diameter; mean diameter; thread depth; or taper.

[0025] The first type of fixing can differ from the second type of fixing in head profile and / or length and / or thread segment length and / or tip profile.

[0026] The first type of fixing can differ from the second type of fixing in one or more dimensions of the fixing. One of the dimensions can comprise a diameter of the fixing, for example a diameter of a portion of the fixing that contacts an aperture in an insert. One of the dimensions can comprise a cross-sectional profile of the fixing, for example a portion of the fixing that contacts an aperture in an insert.

[0027] The surgical kit can comprise a plurality of different surgical implant aperture inserts. The inserts can differ from one another in one or more or all of: a body portion; a distal surface; a proximal surface; an intermediate surface extending between the distal surface and the proximal surface; a through-hole extending between the distal surface and the proximal surface; a through-hole surface; a surgical implant aperture contact portion; a surgical fixing contact portion. The difference can be one or more or all of: material composition; porosity; dimension; spacing between features; size of features; extent of features; shape or profile of features.

[0028] The difference can be or comprise a tilt of the hole. The insert can have an insert axis. The insert axis can extend from distal to proximal, for example perpendicular to the proximal surface of the insert and / or perpendicular to the distal surface of the insert. The through-hole can have a hole axis. The hole axis can be parallel to and for example correspond to the insert axis. The hole axis can be tilted or have a tilt relative to the insert axis. The tilt can be between 0 degrees and 25 degrees relative to the insert axis. The tilt can be between 0 degrees and 17 degrees relative to the insert axis.

[0029] The first aspect of the present disclosure can comprise any of the features, options and possibilities set out elsewhere in this document, including in the other aspects and descriptions of embodiments. In particular, the surgical implant aperture insert can comprise any of the features, options or possibilities set out in the second aspect.

[0030] According to a second aspect of the disclosure, there is provided a surgical implant orifice insert, the insert comprising:

[0031] a body portion providing a distal surface and a proximal surface, the body portion further providing an intermediate surface extending between the distal surface and the proximal surface;

[0032] a through-hole extending between the distal surface and the proximal surface, the through-hole being defined by a through-hole surface;

[0033] wherein the intermediate surface comprises a surgical implant orifice contact portion;

[0034] wherein the through-hole surface comprises a surgical fixation contact portion;

[0035] wherein the intermediate surface defines a first cross-sectional profile in a plane, wherein the through-hole surface defines a second cross-sectional profile in the plane, and wherein the second profile lies within the first profile.

[0036] At least a portion of the insert can be formed of a porous material. The porous material can be selected and / or adapted to promote bone ingrowth.

[0037] At least a portion of the insert can be formed of a deformable material. The deformable material can be selected and / or adapted to deform upon engagement by a surgical fixation. The deformable material can be selected and / or adapted to deform upon engagement with a surgical implant orifice.

[0038] The porous material and the deformable material can be the same material or can be different materials.

[0039] The insert can provide a first portion of the body portion formed of a first material, and a second portion of the body portion formed of a second material. The first material and the second material can differ from each other in their porosity and / or deformability. The first portion of the body portion can define the through-hole surface. The second portion of the body portion can define the intermediate surface. The distal surface and / or the proximal surface can be defined in part by the first material and in part by the second material. The body portion can comprise a core of the first material. The body portion can comprise the core radially surrounded by the second material.

[0040] At least a portion of the insert can be formed of a deformable material having a first pre-deformation state for the through-hole surface. The deformable material can have a first post-deformation state for the through-hole surface. The shape of the through-hole surface in the first post-deformation state can be different than the shape of the through-hole surface in the first pre-deformation state. For example, the shape of the through-hole surface can be deformed to engage with a surgical fixation member (e.g., one or more contact surfaces thereof, e.g., a thread provided by the surgical fixation member, e.g., a head of the surgical fixation member). The insert can provide the through-hole surface in the first post-deformation state adapted to engage with one or more surfaces of the surgical fixation member.

[0041] The insert can provide that the through-hole surface comprises a bone-engaging surgical fixation member contact portion. The contact portion can be provided by deformation of the through-hole surface and / or by a thread provided by the through-hole surface and / or by a surgical fixation member cutting a thread in the through-hole surface.

[0042] At least a portion of the insert can be formed of a deformable material having a second pre-deformation state for the intermediate surface. The deformable material can have a second post-deformation state for the intermediate surface. The shape of the intermediate surface in the second post-deformation state can be different than the shape of the intermediate surface in the second pre-deformation state. For example, the shape of the intermediate surface can be deformed to engage with a surgical implant aperture (e.g., one or more contact surfaces thereof, e.g., a through-hole thereof). The insert can provide a through-intermediate surface in the second post-deformation state adapted to engage with one or more surfaces of the surgical implant aperture. The one or more surfaces can comprise or can be: a surface defining the surgical implant aperture; a surface defining a through-hole in the surgical implant; a distal surface of the surgical implant; a proximal surface of the surgical implant.

[0043] One or both of the distal surface and / or the proximal surface of the insert can be shaped as a continuation of and / or complementary to a segment of the surgical implant, e.g., shaped to the profile of an adjacent segment of the surgical implant in use. The segment of the surgical implant can be planar or can be curved, e.g., partially hemispherical. The curvature of one or both of the distal surface and / or the proximal surface of the insert can have a radius, e.g., the same radius as the segment of the surgical implant.

[0044] One or both of the distal surface and / or the proximal surface of the insert can be shaped to be flush with a segment of the surgical implant, e.g., to the profile of an adjacent segment of the surgical implant in use. The segment of the surgical implant can be planar or can be curved, e.g., partially hemispherical.

[0045] One or both of the distal surface and / or the proximal surface of the insert can be shaped to be recessed relative to a segment of the surgical implant, for example to be flush with a profile of an adjacent segment of the surgical implant in use. The segment of the surgical implant can be planar or can be curved, for example partially hemispherical. The curvature of one or both of the distal surface and / or the proximal surface of the insert can have a radius, for example a radius that is greater than a radius of the segment of the surgical implant.

[0046] One or both of the distal surface and / or the proximal surface of the insert can be shaped to be convex of a segment of the surgical implant, for example to be convex of a profile of an adjacent segment of the surgical implant in use. The convex element of the insert can be a head segment or a flange segment. The segment of the surgical implant can be planar, for example a flange, or can be curved, for example a plate configured to correspond to a bone location.

[0047] The intermediate surface can define a first cross-sectional profile in a plane that is a regular shape, for example a circle. The through-hole surface can define a second cross-sectional profile in the plane that is a regular shape, possibly of the same type of regular shape, for example a circle. The regular shapes can be concentric, for example concentric circles. The insert can provide that the first cross-sectional profile in the plane is a circular profile. The insert can provide that the second cross-sectional profile in the plane is also a circular profile. The insert can provide that the diameter of the second cross-sectional profile is smaller than the diameter of the first cross-sectional profile.

[0048] The insert can provide that the cross-section of the second cross-sectional profile decreases along the axis of the through-hole and / or along the axis of the body portion. The second cross-sectional profile can taper away from the distal end and / or towards the proximal end, for example by tapering the bore from the distal end to the proximal end.

[0049] The insert can provide a tapered through-hole, for example with threads.

[0050] The insert can provide that the cross-section of the first cross-sectional profile decreases along the axis of the through-hole and / or along the axis of the body portion. The profile can decrease due to a tapering of the intermediate surface over a portion of the transition from the distal end to the proximal end. The intermediate surface can have a maximum first cross-sectional profile at the distal surface. The intermediate surface can have a minimum first cross-sectional profile at the proximal surface. The intermediate surface can have the minimum first cross-sectional profile from an intermediate location to the proximal surface, for example to provide a cylindrical segment. The intermediate surface can transition from the maximum cross-sectional profile to the minimum cross-sectional profile to provide a curved intermediate surface, for example a bowl-shaped segment.

[0051] The insert can have an insert axis. The insert axis can extend from distal to proximal, e.g. perpendicular to a proximal surface of the insert and / or perpendicular to a distal surface of the insert. The through hole can have a hole axis. The hole axis can be parallel to and e.g. correspond to the insert axis. The hole axis can be tilted with respect to the insert axis or have a tilt with respect to the insert axis.

[0052] By having an insert with multiple rotational positions, a plurality of different orientations of the tilt can be provided, e.g. with respect to the insert and / or with respect to the surgical implant. The insert can have a first rotational position for a first orientation of the tilt and a second rotational position for a second orientation of the tilt. The tilt of the insert can be the same in one or more or all of the multiple rotational positions.

[0053] The tilt can be between 0 and 25 degrees with respect to the insert axis. The tilt can be between 0 and 17 degrees with respect to the insert axis.

[0054] The insert can be provided with an intermediate surface provided with one or more surgical implant holding elements.

[0055] The insert can be provided with one or more surgical implant holding elements being male holding elements and / or female holding elements, e.g. adapted to engage with complementary elements provided on the surgical implant, e.g. within a surface defining a surgical implant aperture. The insert can be provided with a plurality of radially extending male holding elements, e.g. cylindrical protrusions.

[0056] The insert can be provided with threaded surgical implant holding elements.

[0057] The insert can be a 3D printed insert. The insert can be 3D printed together with one or more other components, e.g. a surgical implant aperture and / or a surgical implant.

[0058] A second aspect of the present disclosure can comprise any of the features, options and possibilities set out elsewhere in this document, including in the other aspects and descriptions of embodiments.

[0059] According to a third aspect of the present disclosure, there is provided a method of configuring a surgical implant aperture in a surgical implant, the method comprising

[0060] a) selecting a surgical fixation to be inserted into the surgical implant aperture;

[0061] b) inserting a surgical implant aperture insert into the surgical implant aperture;

[0062] c) inserting the surgical fixation through the insert and through the aperture, wherein the insert comprises:

[0063] a body portion providing a distal surface and a proximal surface, the body portion further providing an intermediate surface extending between the distal surface and the proximal surface;

[0064] a through-hole extending between the distal surface and the proximal surface, the through-hole being defined by a through-hole surface;

[0065] wherein the intermediate surface comprises a surgical implant orifice contact portion that contacts the surgical implant orifice after insertion of the insert into the orifice;

[0066] wherein the through-hole surface comprises a surgical fixation member contact portion that contacts the surgical fixation member after insertion of the surgical fixation member into the hole.

[0067] The method can comprise the insert further providing that the intermediate surface defines a first cross-sectional profile in a plane, wherein the through-hole surface defines a second cross-sectional profile in the plane, and wherein the second profile is within the first profile.

[0068] The method can comprise the insert providing at least a portion of the insert being formed of a deformable material. The method can comprise deforming the deformable material by engagement of the surgical fixation member with the deformable material and / or by insertion of the surgical fixation member into the through-hole.

[0069] The method can further comprise the insert providing at least a portion of the insert being formed of a deformable material, the deformable material having a first pre-deformation state for the through-hole surface and a first post-deformation state for the through-hole surface. The method can further provide that a shape of the through-hole surface in the first post-deformation state is different from a shape of the through-hole surface in the first pre-deformation state. The difference in shape can be caused by engagement of the surgical fixation member with the deformable material and / or by insertion of the surgical fixation member into the through-hole.

[0070] The method can further comprise the insert providing the through-hole surface in the first post-deformation state, the through-hole surface being engaged with one or more surfaces of the surgical fixation member.

[0071] The method can provide that the through-hole surface comprises a bone-engaging surgical fixation member contact portion.

[0072] The method can further provide that the insert provides at least a portion of the insert being formed of a deformable material, the deformable material having a second pre-deformation state for the intermediate surface and a second post-deformation state for the intermediate surface. The method can further provide that a shape of the intermediate surface in the second post-deformation state is different from a shape of the intermediate surface in the second pre-deformation state. The difference in shape can be caused by engagement of the surgical implant orifice with the deformable material and / or by insertion of the insert into the surgical implant orifice.

[0073] The method can further provide that the insert provides an intermediate surface in the second deformed post-state, the intermediate surface engaging one or more surfaces of the surgical implant aperture.

[0074] The method can comprise selecting:

[0075] a) one or more surgical implant apertures for receiving a first size or first type of fixation member, e.g. for insertion of an insert into the surgical implant aperture;

[0076] b) one or more surgical implant apertures for receiving an insert but not a surgical fixation member;

[0077] c) one or more surgical implant apertures for receiving a second size or second type of fixation member, e.g. for insertion of a surgical implant aperture without an insert.

[0078] The method can comprise providing different types of inserts in two or more apertures. The different types can differ from each other in one or more or all of: body portion; distal surface; proximal surface; intermediate surface extending between the distal surface and the proximal surface; through hole extending between the distal surface and the proximal surface; through hole surface; surgical implant aperture contact portion; surgical fixation member contact portion. The difference can be one or more or all of: material composition; porosity; size; spacing between features; size of features; extent of features; shape or profile of features.

[0079] The difference can be or comprise a tilt of the hole. The insert can have an insert axis. The insert axis can extend from distal to proximal, e.g. perpendicular to the proximal surface of the insert and / or perpendicular to the distal surface of the insert. The through hole can have a hole axis. The hole axis can be parallel to and e.g. correspond to the insert axis. The hole axis can be tilted or have a tilt relative to the insert axis. The tilt can be between 0 and 25 degrees relative to the insert axis. The tilt can be between 0 and 17 degrees relative to the insert axis.

[0080] The difference can be a rotational position of the insert, in particular in the case of a tilted hole being provided.

[0081] A third aspect of the present disclosure can include any of the features, options and possibilities set out elsewhere in this document, including in the other aspects and descriptions of embodiments.

[0082] According to a fourth aspect of the present disclosure, there is provided a method of implanting a surgical implant, the method comprising:

[0083] a) selecting a surgical implant, the surgical implant having at least one surgical implant aperture;

[0084] b) implanting a surgical implant at a surgical site in a patient's body;

[0085] c) selecting a surgical fixation to insert into a surgical implant orifice;

[0086] d) selecting a surgical implant orifice insert to insert into an orifice of a surgical implant;

[0087] e) inserting the surgical implant orifice insert into the orifice of the surgical implant;

[0088] f) inserting the surgical fixation through the insert and through the orifice and into a site in the patient's body;

[0089] wherein the implant comprises:

[0090] a body portion providing a distal surface and a proximal surface, the body portion further providing an intermediate surface extending between the distal surface and the proximal surface;

[0091] a through hole extending between the distal surface and the proximal surface, the through hole being defined by a through hole surface;

[0092] wherein the intermediate surface comprises a surgical implant orifice contact portion that contacts the surgical implant orifice after insertion of the insert into the orifice;

[0093] wherein the through hole surface comprises a surgical fixation contact portion that contacts the surgical fixation after insertion of the surgical fixation into the hole.

[0094] The method can comprise; the insert further providing that the intermediate surface defines a first cross-sectional profile in a plane, wherein the through hole surface defines a second cross-sectional profile in the plane, and wherein the second profile is within the first profile.

[0095] The method can comprise; the insert providing at least a portion of the insert being formed of a deformable material. The method can comprise deforming the deformable material by engagement of the surgical fixation with the deformable material and / or by insertion of the surgical fixation into the through hole.

[0096] The method can further comprise; the insert providing at least a portion of the insert being formed of a deformable material, the deformable material having a first pre-deformation state for the through hole surface and a first post-deformation state for the through hole surface. The method can further provide; a shape of the through hole surface in the first post-deformation state being different from a shape of the through hole surface in the first pre-deformation state. The difference in shape can be caused by engagement of the surgical fixation with the deformable material and / or insertion of the surgical fixation into the through hole.

[0097] The method can further include the insert providing a through-hole surface in the first post-deformation state, the through-hole surface engaging one or more surfaces of the surgical implant aperture.

[0098] The method can provide that the through-hole surface comprises a bone-engaging surgical implant contact portion.

[0099] The method can further provide that the insert provides at least a portion of the insert formed of a deformable material, the deformable material having a second pre-deformation state for the intermediate surface and a second post-deformation state for the intermediate surface. The method can further provide that a shape of the intermediate surface in the second post-deformation state is different than a shape of the intermediate surface in the second pre-deformation state. The difference in shape can be caused by engagement of the surgical implant aperture with the deformable material and / or by insertion of the insert into the surgical implant aperture.

[0100] The method can further provide that the insert provides an intermediate surface in the second post-deformation state, the intermediate surface engaging one or more surfaces of the surgical implant aperture.

[0101] The method can include selecting:

[0102] d) one or more surgical implant apertures for receiving a first size or first type of fixation member, e.g., for insertion of an insert into the surgical implant aperture;

[0103] e) one or more surgical implant apertures for receiving an insert but not a surgical fixation member;

[0104] f) one or more surgical implant apertures for receiving a second size or second type of fixation member, e.g., for insertion of a surgical implant aperture without an insert.

[0105] The method can include providing different types of inserts in two or more apertures. The different types can differ from one another in one or more or all of: body portion; distal surface; proximal surface; intermediate surface extending between the distal surface and the proximal surface; through-hole extending between the distal surface and the proximal surface; through-hole surface; surgical implant aperture contact portion; surgical fixation member contact portion. For such features, the difference can be one or more or all of: material composition; porosity; size; spacing between features; size of features; extent of features; shape or profile of features.

[0106] The difference can be or include a tilt of the bore. The insert can have an insert axis. The insert axis can extend from distal to proximal, e.g. perpendicular to a proximal surface of the insert and / or perpendicular to a distal surface of the insert. The through bore can have a bore axis. The bore axis can be parallel to and e.g. correspond to the insert axis. The bore axis can be tilted or have a tilt relative to the insert axis. The tilt can be between 0 and 25 degrees relative to the insert axis. The tilt can be between 0 and 17 degrees relative to the insert axis.

[0107] The difference can be a rotational position of the insert, in particular in case of a tilted bore.

[0108] A third aspect of the present disclosure can include any of the features, options and possibilities set out elsewhere in this document, including in the other aspects and descriptions of embodiments. BRIEF DESCRIPTION OF DRAWINGS

[0109] Embodiments of the present disclosure will be described below, by way of example only, with reference to the drawings in which like reference numerals relate to like elements, and in which:

[0110] Figure 1 is an illustration of various surgical implants to which the present disclosure is applicable;

[0111] Figure 2a is a side view of an interference fit insert according to a first embodiment;

[0112] Figure 2b is a cross-sectional view of the interference fit insert of Figure 2a ;

[0113] Figure 2c is a cross-sectional view of the interference fit insert of Figure 2b ;

[0114] Figure 3 is an illustration of various sizes and types of fixation elements that can be used with the present disclosure;

[0115] Figure 4 is a cross-sectional elevation view of another embodiment of an insert, shown inserted into a through bore of an acetabular shell;

[0116] Figure 5a is an illustration of another embodiment of the present disclosure used in the context of an acetabular cage;

[0117] Figure 5b is an illustration of another embodiment of the present disclosure also used in the context of an acetabular shell, wherein the insert incorporates a flange engagement head;

[0118] Figures 6a to 6eis an illustration of further embodiments of the disclosure in which different portions of the insert are formed from different materials and / or in different ways;

[0119] Figure 7a is a side view of an insert having mating features;

[0120] Figure 7b is a perspective view of an acetabular cup having a screw hole with mating features and an insert with mating features inserted into the screw hole of the acetabular shell;

[0121] Figure 8a is a cross-sectional side view of an embodiment of an insert having a first through-hole orientation; and

[0122] Figure 8b is a cross-sectional side view of an embodiment of an insert having a second through-hole orientation. DETAILED DESCRIPTION

[0123] Referring to the drawings, Figure 1 A series of perspective views showing examples of surgical implants, an acetabular revision cage 2, a partial acetabular cup 4, and an acetabular cup 6. Each of these surgical implants 2, 4, 6 is provided with a large number of through-holes 8 to accommodate fixation members [not shown] in use. In most surgical cases, only a small number of the through-holes 8 are used, while the others are left as open through-holes 8.

[0124] These surgical implants are merely some examples of the many surgical implants to which the present disclosure is directed, for example, the present disclosure can be used for trauma implants, such as trauma plates, and for other orthopedic examples, such as femoral implants, including distal locking femoral stems.

[0125] Figure 2a A side perspective view of an embodiment of an insert 20 is provided, described with reference to an acetabular use environment. The insert 20 includes a body portion 22 having a distal surface 24 provided with a distal opening 26 at a distal end of a through-hole 28 extending through the body portion 22 to a proximal opening 30 provided in a proximal surface 32 of the body portion 22; see Figure 2b .

[0126] The insert 20 is suitable for insertion into through-holes 8 of various surgical implants, such as acetabular shells, cages, trauma plates, and / or distal locking femoral stems.

[0127] To retain the insert 20 in the surgical implant 2, 6, 8, the outer diameter dl of at least the section S of the insert 20 is interference fit with a complementary section of the surgical implant 2, 4, 6. This section can be another section to the section S shown, or can be the entire profile of the outer surface 34. This retention provides a first level of retention of the insert 20 relative to the surgical implant 2, 6, 8. Further and increased levels of retention are described below.

[0128] The insert 20 is formed of a porous material for promoting bone ingrowth. In this embodiment, the entire body portion 22 is formed of a porous material for promoting bone ingrowth. Thus, providing the insert 20 in the through hole 8 in the surgical component 2, 4, 6 has the benefit of increasing the surface area of the surgical component 2, 4, 6 available for bone ingrowth. The insert 20 can be used to fill the through hole 8 to a large extent even if the insert 20 is not further used.

[0129] The insert 20 can also act as an adapter to allow different sizes and / or types of fixation to cooperate with the insert 20, and thus with the surgical implant 2, 4, 6, compared to fixation that would normally cooperate directly with the surgical implant 2, 4, 6 by being inserted in the through hole 8 without any insert 20. The diameter d2 of the through hole 28 is smaller than the diameter of the through hole 8 of the surgical device 2, 4, 6; this diameter is equal to the outer diameter dl of the insert 20 plus a tolerance. By way of example only, a typical diameter for d2 would be 2mm to 3.5mm.

[0130] While in the absence of the insert 20, the through hole 8 can securely receive a fixation having an outer diameter matching dl, in the presence of the insert 20, the through hole 28 allows a smaller diameter fixation, such as a locking screw, to securely engage with the through hole 8, and thus with the surgical implant 2, 4, 6. This provides a second level of retention of enhanced level. This means that the surgeon can select from the whole set of such through holes 8 those through holes 8 that: best receive a larger size or first type of fixation; best receive a smaller size or second type of fixation, and thus should be provided with the insert 20; and through holes 8 that do not need to be provided with a fixation, but where the insert 20 is to be provided to promote bone ingrowth. The surgeon can still choose some through holes 8 to receive no fixation or insert 20. This flexibility of choice allows for good stability of the implant, optimal fixation means and / or type to be used, and / or maximum bone ingrowth to be promoted.

[0131] Figure 2b The thread 36 is shown formed over the entire length of the sidewall 38. In other examples, not shown, the thread 36 can extend only partially along the length of the sidewall 38. Figure 2a and Figure 2bThe thread 36 in the insert 20 has a constant diameter and is complementary to the external thread of a fixing member such as a locking screw.

[0132] As Figure 2c shown, when the fixing member 40 is inserted into this form of insert 20, the threads 41 and 21 engage with each other respectively and there is no deformation of the material of the insert 20 or fixing member 40.

[0133] The insert 20 in any of the embodiments can be 3D printed. The insert 20 can be 3D printed so that it is already in situ within the through hole 8 of the surgical implant 2, 4, 6 or can be inserted separately into a particular through hole 8.

[0134] Figure 3 A series of typical fixing members 40a, 40b, 40c, 40d and 40e are shown for direct cooperation with the surgical implant 2, 4, 6 which can cooperate with the insert 20 as an adapter in reduced diameter form and thus with the surgical component 2, 4, 6.

[0135] The example fixing member 40e is a locking screw. The diameter d2 of the through hole 28 corresponds to the diameter d3 of the locking screw head 30 but the diameter d3 is slightly increased to cause deformation of the insert 20 upon insertion of the fixing member. The level of deformation of the surface of the insert 20 relative to the implant base is entirely sufficient to obtain an interference fit, for example in the range of 1 to 5%. The insert 20 is slightly larger in size to allow for the deformation. The deformation is controlled by the configuration of the insert 20 and its structure. This can be controlled via porosity, strut length and thickness, for example if the insert is 3D printed or it can be controlled via material properties if, for example, the material is solid.

[0136] As Figure 4 shown, the present disclosure provides another embodiment in which the insert 20 is shown in place within an opening in a surgical implant such as the through hole 8, in this case in the form of a hip cup 6.

[0137] The geometry of the insert 20 is shaped so that its distal surface 24 is complementary to and represents a continuation of the surrounding distal surface 50 of the hip cup 6 into which it is inserted. In this way, in use, there is no interference with the intended profile of the distal surface 50 and there is no interference with the opposing parts of the surgical implant system (not shown). In Figure 4 In the example shown, the distal surface 24 of the body portion 22 is concave so that when the insert 20 is positioned within the through hole 8, the curvature of the hip cup shell 6 is continuous over the surface of the distal surface 24 of the body portion 22.

[0138] In this embodiment, as previously described with respect to the previous embodiment, the through-hole 28 of the insert 20 still extends through the through-hole 8 of the surgical implant 6, but in doing so, it narrows the diameter of the receiving fixation member to the diameter d2 of the through-hole 28. In this embodiment, the diameter of the through-hole 28 is reduced to a minimum value d3 as the through-hole 28 tapers from distal to proximal. When the fixation member (in this case, the locking screw) is driven through the through-hole 28 of the insert 20, the locking screw deforms the porous material forming the insert 20, such that the head of the locking screw 22 is captured within the deformed material, thereby locking the insert 20 in place of both the locking screw and the surgical implant 6.

[0139] like Figure 4 As shown, the through-hole 8 of the surgical implant 6 is tapered. Thus, the main body portion 22 of the insert 20 can have a tapered and complementary shape corresponding to the through-hole 8, such that the insert 20 fills the through-hole 8 once inserted.

[0140] like Figure 5a As shown, the insert 20 is depicted in one of a plurality of through holes 8 in the plate section 54 of the acetabular cage 2. The insert 20 can be used in various configurations to provide an adapter and promote bone growth.

[0141] exist Figure 5b In the illustrated embodiment, the insert 20 has a flange section 52 on its proximal side. The flange section 52 may be formed of a porous material to facilitate inward bone growth. The insert 20 is disposed in a through-hole 8 in a plate section 54 of the acetabular cage 2. The diameter d4 of the proximal flange section 52 is larger than the diameter d5 of the through-hole 8 in the plate section 54 at its widest point. In use, this flange section 52, particularly its distal side 56, engages with the proximal side 58 of the plate section 54. The flange section 52 is particularly useful for inserts 20 used for cage or plate applications because the insert 20 can be positioned such that the flange section 52 is located between the surgical implant and the bone. This increases the bone contact area to facilitate inward bone growth. When the flange is positioned on the upper end 12 of the body portion 4, the flange section 52 prevents the insert 2 from being forced through the screw holes 10 of the surgical device 20. As shown in the figure, a distal flange section 59 is also provided, the diameter of which is larger than the diameter d5 of the through hole 8. This helps to retain the insert 20 in the acetabular cage 2.

[0142] Flange segment 52 can be planar, such as... Figure 5b As shown, it may be concave or convex, such that it complements the surgical device intended to be inserted therein. For example, the flange section 52 may be concave and / or convex, such that when the insert 20 is positioned within the through-hole 8, the curvature of the surgical device is continuous on the surface of the flange and on the upper end 12 or lower end 14 of the body portion 4.

[0143] For any of the embodiments of the insert 20, the material making up the insert can also be deformable in surgical use. This deformability can apply to the entire insert 20. Alternatively, in Figures 6a to 6e In the illustrated embodiment, different regions of the body portion 22 of the insert are formed of different materials. For example, the outer volume 60 of the body portion 22 can be formed of a first material for providing strength to the insert 20, while the inner volume 62 of the body portion 22 including the through-hole 28 can be formed of a different material (e.g., a porous and / or optimized for deformation material), and potentially also support bone ingrowth. The different materials can be non-porous materials, or porous materials having different properties than the non-porous material of the outer volume 60. The material of the outer volume can be a different porous material. The different materials can differ from one another by controlling the type of lattice, the type of material, the lattice size, the pore size, etc.

[0144] Referring to Figure 6a and Figure 6b , a first configuration is used having a structural outer layer 60 and a surface lattice 62 located within it. The surface lattice 62 defines the proximal portion of the through-hole 8, and the structural outer layer 60 defines the distal portion of the through-hole 8. The fixture 40 will engage with both, possibly causing deformation of the surface lattice 62 and / or the structural layer 60.

[0145] In Figure 6c , a second configuration is used having a structural layer 60 and a more fine and thus less porous 3D lattice 62 within it.

[0146] In Figure 6d and Figure 6e , a third configuration is provided having a structural outer layer 60 and an inner DPSAffixium TM 3D lattice 62.

[0147] Figure 7a and Figure 7b shows another optional configuration of the present disclosure. As Figure 7a shown, the insert 20 includes a body portion 22 having a distal surface 24 provided with a distal opening 26 at a distal end of a through-hole 28 extending through the body portion 22 to a proximal opening 30 provided in a proximal surface 32 of the body portion 22. The diameter d 10 of the through-hole 28 is smaller than the diameter d 11 of the through-hole 8 of the surgical implant 6, again allowing different sizes or types of fixtures to engage with the through-hole 28, and then with the bone.

[0148] In this embodiment, the insert 20 includes a plurality of mating features 70 disposed on the outer surface 34 of the body portion 22 for locking the insert 20 to, for example Figure 7b surgical implants 2, 4, 6 of the type shown. The mating features 70 can be female or male, with the male version shown. In Figure 7a and Figure 7b the example shown, the mating features 70 are bayonet fittings in the form of protrusions from the outer surface 34. In other examples, not shown, the mating features can be threads.

[0149] The insert 20 is provided with a through hole 28 having a first section 72 and a narrower section 74 closer to the proximal end. The first section 72 is for receiving the head of the fixation member which is of a larger diameter than the shaft of the fixation member in use.

[0150] The insert 20 is configured to be insertable into the through hole 8 of a variety of surgical devices (e.g. acetabular shells 4, cages 2, trauma plates and / or distal locking femoral stems) where the through hole 8 of the surgical implant 2, 4, 6 has been modified to receive the mating features 70 of the insert 20. As Figure 7b shown, in this case, the acetabular cup 6 has a plurality of through holes 8. Some of the through holes, such as through hole 8*, are unaltered and thus not suitable for receiving the insert 20 with protrusions 70. The through hole 8' has been provided with a modified design and thus includes a plurality of complementary female mating features 76 for engaging with the male mating features 70 of the insert 20. In this case, each female mating feature 76 has a first recessed section 78 which allows for axial movement of the male mating portion 70 relative to the insert 20, then a curved section 80 which encourages the insert 20 to begin to rotate relative to the surgical implant 6 and finally a retention section 82. The retention section 82 resists any axial movement of the insert 20 and the surgical implant 6 relative to each other. The retention recessed section 82 is provided in a common plane perpendicular to the axis of the through hole 8 along with the other retention recessed sections 82.

[0151] The insert 20 is shown in the retained position in the through hole 8 + with the male retention feature 70 in the retention section of the female retention feature 76.

[0152] As Figure 7a shown, the insert 20 provides a through hole 28 of a smaller diameter than the through holes 8' and 8* in the surgical implant 6, thereby narrowing the diameter of the through hole 28 and thus the through hole into which the fixation member for fastening the surgical device 2, 4, 6 and the bone is inserted.

[0153] As Figure 7bAs shown, the through hole 8 of the surgical implant 6 can be tapered. As such, the proximal body portion of the insert 20 has a corresponding tapered and complementary shape so that the insert 20 once inserted fills the through hole 8.

[0154] In Figure 7a and Figure 7b the configuration shown, the through hole 28 is unthreaded. In this configuration, the threads of the fixation member, such as a locking screw, can be self-tapping and cut into the sidewall 36 of the hole to secure the fixation member to the insert 20.

[0155] In other configurations, not shown, the through hole 28 can include threads formed in the sidewall 36 along at least a portion of its length. In other configurations, also not shown, the threads can extend only partially along the length of the sidewall 36. The threads are complementary to the threads of the fixation member

[0156] The mating features 70, 76 can be positioned to allow the surgeon to change the insertion angle of the surgical implant 2, 4, 6 and / or the insert 20. The change in insertion angle allows the surgeon to also change the insertion angle of the through hole 28 so that it is not aligned with the through hole 8, 10 of the surgical implant 2, 4, 6. The change in insertion angle allows the surgeon to insert a fixation member, such as a locking screw or non-locking screw, at a different angle than was available in the original through hole 8, for example, to access a higher quality area of the bone. If desired, changing the insertion angle can allow the insert 20 to protrude from the surgical implant 2, 4, 6.

[0157] Referring to Figure 8a and Figure 8b different alignment options are provided for the through hole 8 in the insert 20. In Figure 8a the case, the axis F-F of the through hole 8 extends only distally and proximally relative to the insert 20. Thus, the fixation member 40 upon insertion will also follow the alignment of the axis F-F. In Figure 8b the case, the axis P-P of the through hole 8 extends distally and proximally but is also offset or tilted relative to the insert 20. Thus, the fixation member 40 upon insertion will follow the alignment of the axis F-F and be tilted relative to the axis I-I of the insert 20.

[0158] Potentially, in case the insert is a solid material and not deformable, the angle of the through hole 8 containing the corresponding locking feature (fixation 40) can be manufactured with zero offset or with an angular offset within a range. In general, a plurality of inserts 20 with different degrees of offset can be provided, for example up to the varying level that can be used for non-locking fixations, typically 17 degrees, for example in increments of 5 degrees (thus examples of 5 degrees, 10 degrees, 15 degrees). The insert 20 can of course be rotated to different positions within the through hole 8, thus only one angular variant is needed at each offset, as the insert 8 can be rotated to allow the desired angle in the desired direction.

[0159] If the insert is deformable, it can be chosen with a pre-fabricated offset similar to the one described above, but without a mating feature in the through hole 8, as the locking will be achieved by the fixation 40 biting into the material of the insert 20. In another option, the through hole 8 of the insert 20 is made with a high level of porosity and thus very easily deformable. Thus, the user can angle the fixation 40 in the through hole 8 as needed and drive the fixation 40 through the insert 20 at the desired angle. In this case, the maximum angle will be limited by the larger aperture that receives the insert 20.

[0160] The present disclosure also relates to a method of adapting a through hole 8 suitable for a fixation of a first size or type, such as a non-locking screw, to be suitable for a fixation of a second size or type, such as a locking screw. The method comprises the steps of first providing a surgical implant comprising through holes 8, for example for non-locking screw holes, then providing an insert 20 according to any of the examples provided above. Then, the insert 20 is inserted into one of the through holes 8 for non-locking screw holes, and a fixation of the second type, for example a locking screw, is inserted into the through hole 28 of the insert 20.

[0161] A kit for adapting a through hole 8 suitable for example for a non-locking screw to be a through hole 8 suitable for example for a locking screw is also provided. The kit comprises at least two inserts 20 according to the insert described above and at least two different types of fixations.

[0162] While specific embodiments of the present disclosure have been described, it is to be understood that many modifications, additions and / or substitutions can be made within the scope of the claims. While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that there is no intent to limit the concepts of the present disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure and the appended claims.

Claims

1. A surgical implant system, the system comprising: one or more surgical implants, at least one of the surgical implants having a distal surface and a proximal surface, a surgical implant bore extending between the distal surface and the proximal surface; one or more surgical fixations; and one or more surgical implant bore inserts; wherein at least one of the surgical implant bore inserts comprises: a body portion providing a distal surface and a proximal surface, the body portion further providing an intermediate surface extending between the distal surface and the proximal surface; a through-hole extending between the distal surface and the proximal surface, the through-hole being defined by a through-hole surface; wherein the intermediate surface comprises a surgical implant bore contact portion; wherein the through-hole surface comprises a surgical fixation contact portion.

2. The surgical implant system according to claim 1, wherein the surgical implant bore insert, wherein the intermediate surface defines a first cross-sectional profile in a plane, wherein the through-hole surface defines a second cross-sectional profile in the plane, and wherein the second profile lies within the first profile.

3. The surgical implant system according to claim 1 or claim 2, further comprising two or more surgical fixations, including at least one first type of fixation and at least one second type of fixation.

4. The surgical implant system according to claim 3, wherein one or more screw fixations are provided, including one or more non-lockable fixations as the first type and / or one or more lockable fixations as the second type.

5. The surgical implant system according to claim 3 or claim 4, wherein the first type of fixation differs from the second type of fixation in one or more properties of a threaded portion of the fixation.

6. The surgical implant system according to any one of claims 3 to 5, wherein the first type of fixation differs from the second type of fixation in one or more dimensions of the fixation, such as a diameter of the fixation.

7. The surgical implant system according to any preceding claim, further comprising a plurality of different surgical implant bore inserts, the inserts differing from one another in one or more or all of: the body portion; the distal surface; the proximal surface; the intermediate surface extending between the distal surface and the proximal surface; the through-hole extending between the distal surface and the proximal surface; the through-hole surface; the surgical implant bore contact portion; the surgical fixation contact portion.

8. The surgical implant system according to any preceding claim, further comprising a plurality of different surgical implant bore inserts, the inserts differing from one another in one or more or all of: material composition; porosity; dimensions; spacing between features; size of features; extent of features; shape or profile of features.

9. A surgical implant system according to any preceding claim, further comprising a plurality of different surgical implant aperture inserts, the inserts differing from one another in terms of the inclination of the aperture.

10. A surgical implant system according to claim 9, the inserts having an insert axis extending distally to proximally, the through hole having a hole axis which is inclined relative to the insert axis.

11. A surgical implant system according to claim 10, wherein the inclination is between 0 and 25 degrees relative to the insert axis.

12. A surgical implant system according to any preceding claim, wherein the surgical implant is one or more of: an acetabular shell; a partial acetabular shell; an acetabular cage; a femoral implant; a trauma treatment implant.

13. A surgical implant system according to any preceding claim, wherein the surgical implant is provided with an aperture surface, the aperture surface being provided with one or more insert retaining elements.

14. A surgical implant aperture insert, the insert comprising: a body portion providing a distal surface and a proximal surface, the body portion further providing an intermediate surface extending between the distal surface and the proximal surface; a through hole extending between the distal surface and the proximal surface, the through hole being defined by a through hole surface; wherein the intermediate surface comprises a surgical implant aperture contact portion; wherein the through hole surface comprises a surgical fixation contact portion; wherein the intermediate surface defines a first cross-sectional profile in a plane, wherein the through hole surface defines a second cross-sectional profile in the plane, and wherein the second profile lies within the first profile.

15. A surgical implant aperture insert according to claim 14, wherein at least a portion of the insert is formed from a porous material adapted to promote bone ingrowth.

16. A surgical implant aperture insert according to claim 14 or claim 15, wherein at least a portion of the insert is formed from a deformable material adapted to deform upon engagement by a surgical fixation.

17. A surgical implant aperture insert according to any of claims 14 to 16, wherein at least a portion of the insert is formed from a deformable material having a first pre-deformation state for the through hole surface and a first post-deformation state for the through hole surface, the shape of the through hole surface in the first post-deformation state being different to the shape of the through hole surface in the first pre-deformation state.

18. A surgical implant aperture insert according to claim 17, wherein the through hole surface in the first post-deformation state is adapted to engage one or more surfaces of a surgical fixation.

19. A surgical implant aperture insert according to any of claims 14 to 18, wherein the through hole surface comprises a bone-engaging surgical fixation contact portion.

20. The surgical implant orifice insert according to any one of claims 14 to 19, wherein at least a portion of the insert is formed from a deformable material having a second pre-deformation state for the intermediate surface and a second post-deformation state for the intermediate surface, the shape of the intermediate surface in the second post-deformation state being different from the shape of the intermediate surface in the second pre-deformation state.

21. The surgical implant orifice insert according to claim 20, wherein the intermediate surface in the second post-deformation state is adapted to engage with one or more surfaces of a surgical implant orifice.

22. The surgical implant orifice insert according to any one of claims 14 to 21, wherein one or both of the distal surface and the proximal surface are shaped as a continuation of and / or complementary to a profile of an adjacent section of a surgical implant in use.

23. The surgical implant orifice insert according to any one of claims 14 to 22, wherein the through-hole surface is provided with a thread.

24. The surgical implant orifice insert according to any one of claims 14 to 23, wherein the first cross-sectional profile in a plane is a circular profile, and wherein the second cross-sectional profile in the plane is also a circular profile and the second cross-sectional profile has a diameter that is smaller than the diameter of the first cross-sectional profile.

25. The surgical implant orifice insert according to any one of claims 14 to 24, wherein the cross-section of the second cross-sectional profile decreases along the axis of the through-hole, e.g. due to a tapering of the bore from a distal end to a proximal end.

26. The surgical implant orifice insert according to any one of claims 14 to 25, wherein the cross-section of the first cross-sectional profile decreases along the axis of the through-hole, e.g. due to a tapering of the intermediate surface over a portion of the transition from a distal end to a proximal end.

27. The surgical implant orifice insert according to any one of claims 14 to 26, wherein the intermediate surface is provided with one or more surgical implant retaining elements.

28. The surgical implant orifice insert according to any one of claims 14 to 27, wherein the one or more surgical implant retaining elements are male retaining elements and / or female retaining elements adapted to engage with complementary elements provided on a surgical implant, e.g. within a surface defining a surgical implant orifice.

29. The surgical implant orifice insert according to any one of claims 14 to 28, wherein the insert is 3D-printed.

30. The surgical implant orifice insert according to any one of claims 14 to 29, wherein a first portion of the body portion is formed from a first material and a second portion of the body portion is formed from a second material, the first material and the second material differing from each other in their porosity and / or deformability.

31. The surgical implant orifice insert of any of claims 14 to 30, wherein the insert has an insert axis extending distally to proximally, and the through-hole has a hole axis that is tilted relative to the insert axis.

32. A method of configuring a surgical implant orifice, the method comprising a) selecting a surgical fixation to insert into a surgical implant orifice; b) inserting a surgical implant orifice into the surgical implant orifice; c) inserting the surgical fixation through the insert and through the orifice, wherein the insert comprises: a body portion providing a distal surface and a proximal surface, the body portion further providing an intermediate surface extending between the distal surface and the proximal surface; a through-hole extending between the distal surface and the proximal surface, the through-hole being defined by a through-hole surface; wherein the intermediate surface comprises a surgical implant orifice contact portion that contacts the surgical implant orifice after inserting the insert into the orifice; wherein the through-hole surface comprises a surgical fixation contact portion that contacts the surgical fixation after inserting the surgical fixation into the hole; optionally, wherein the intermediate surface defines a first cross-sectional profile in a plane, wherein the through-hole surface defines a second cross-sectional profile in the plane, and wherein the second profile is within the first profile.

33. A method of implanting a surgical implant, the method comprising: a) selecting the surgical implant, the surgical implant having at least one surgical implant orifice; b) implanting the surgical implant at a surgical site in a patient; c) selecting a surgical fixation to insert into a surgical implant orifice; d) selecting a surgical implant orifice insert to insert into the orifice of the surgical implant; e) inserting the surgical implant orifice insert into the orifice of the surgical implant; f) inserting the surgical fixation through the insert and through the orifice and into one site in the patient; wherein the insert comprises: a body portion providing a distal surface and a proximal surface, the body portion further providing an intermediate surface extending between the distal surface and the proximal surface; a through-hole extending between the distal surface and the proximal surface, the through-hole being defined by a through-hole surface; wherein the intermediate surface comprises a surgical implant orifice contact portion that contacts the surgical implant orifice after inserting the insert into the orifice; wherein the through-hole surface comprises a surgical fixation contact portion that contacts the surgical fixation after inserting the surgical fixation into the hole.

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