Inserts for setting the thickness of the cement mantle

Abstract

A surgical implant opening insert (20) for use in a surgical implant system is provided, as well as a surgical implant system for use in arthroplasty, comprising an opening (8) and the surgical implant opening insert. The insert can increase the surface area of ​​surgical components available for bone regrowth and provide fitting means to allow the use of different fixation devices within the opening.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application is related to the application number of a currently unknown co - pending application entitled "Insert for Locking Screw Adaption", filed on the same day as this application by the same applicant with the same patent office. These applications and the patents arising therefrom are incorporated herein by reference, including their specifications and drawings.

[0002] (Field of the Invention) This specification relates to an insert for positioning a through - hole of a surgical device internally. In particular, an insert for setting the thickness of a cement mantle is provided. The disclosure also relates to a kit comprising at least two inserts of the disclosure. The disclosure also relates to a method for setting the thickness of the cement mantle of a liner fixed with cement during surgery.

Background Art

[0003] Arthroplasty is a well - known surgical procedure in which a diseased and / or damaged living joint is replaced by an artificial joint. For example, in hip arthroplasty surgery, the patient's natural hip joint is partially or entirely replaced by an artificial hip prosthesis.

[0004] Orthopedic implants used in arthroplasty can be fixed in place in contact with bone using a cement composition (e.g., polymethylmethacrylate cement). The cement composition can also be used to fix in place two cooperating implants, such as an acetabular cup and a liner used during hip arthroplasty.

[0005] The cement / implant interface and the bone / cement interface form a mechanical interlock interface involved in implant fixation.

[0006] When securing liners with cement, it is necessary to ensure that there is sufficient cement mantle around them. If there is insufficient cement mantle, the increased shear force risks damaging the cement locking mechanism, which could lead to the collapse of the structure.

[0007] The cement mantle is the space required between the first surgical implant and the second surgical implant, or between the first surgical implant and the bone, and this space will be filled with cement for fixation, stability, and strength.

[0008] The minimum cement mantle thickness is the minimum space required between the first and second surgical implants, providing adequate fixation, stability, and strength within this minimum space. If the cement mantle is too thin, the durability and fixation strength of the prosthesis may be reduced, while if it is too thick, the risk of heat-induced osteonecrosis may increase.

[0009] A proper cemented mantle can be achieved by ensuring that the diameter of the acetabular shell and the liner are a good match. For example, if the liner is too large, this will prevent the formation of a proper cemented mantle between the liner and the shell. Conversely, if the liner is too small, the cemented mantle may be too thick in at least part of the mantle. [Overview of the project] [Means for solving the problem]

[0010] According to a first aspect of this disclosure, a surgical implant opening insert is provided, the insert is, Including a main body portion, the main body portion provides a distal surface and a proximal surface, and the main body portion further provides an intermediate surface extending between the distal surface and the proximal surface. The proximal portion of the intermediate surface includes the surgical implant opening contact portion. A distal portion of the intermediate surface is provided, which is located distal to and extends beyond the surgical implant contact portion, and the distal portion of the intermediate surface provides a cement contact portion. The distal surface is the portion that faces further surgical implants.

[0011] The main body may have an axial range, such as height. The axial range may be considered between the distal and proximal surfaces of the insert and / or along the axis of the surgical implant opening and / or along the axis of the insert. The axial range, such as height, may be greater than the axial range, such as height, of the surgical implant opening.

[0012] The extent of the distal portion of the intermediate surface and / or the extent of the cement contact portion can define the minimum thickness of the cement mantle.

[0013] The insert may provide a proximal portion of a main body having an axial range or height h1, which may be at least the same size as the axial range or height of the surgical implant opening. The insert may also provide a distal portion having an axial range or height h2, which may provide space in use above the distal surface around the surgical implant to set the minimum cement mantle thickness.

[0014] The distal surface of the insert may be shaped to protrude from a section of the surgical implant, for example, from the outline of an adjacent section of the surgical implant when in use. The section of the surgical implant may be flat, for example, like a flange, or curved, for example, like a plate. If inserts are provided having different axial ranges, for example, height h2, to set different minimum cement mantle thicknesses, the distal surface of the insert may be shaped to distinguish the insert from other distal surfaces of inserts having larger or smaller axial ranges. For example, the distal surface of the insert may be dome-shaped, pyramidal, or cubic in shape.

[0015] At least a portion of the insert may be formed of a porous material. The porous material may be selected and / or fitted to facilitate cement interlocking. In addition, some or all of the porous material may be selected and / or fitted to promote internal bone growth.

[0016] At least a portion of the insert may be formed from a deformable material. The deformable material may be selected and / or adapted to deform upon engagement with a surgical fixation device. The deformable material may be selected and / or adapted to deform upon engagement with a surgical implant opening.

[0017] The porous material and the deformable material may be the same material or different materials.

[0018] The insert may provide a first portion of a body formed of a first material and a second portion of a body formed of a second material. The first and second materials may differ from each other in their porosity and / or deformability. The distal portion may be formed of a material having higher porosity than the proximal portion. The distal surface and / or proximal surface may be partially defined by the first material and partially defined by the second material. The body portion may include a core of the first material. The body portion may include a core radially surrounded by the second material.

[0019] The distal surface and / or the surface facing the further surgical implant may be shaped to be complementary to the shape of the adjacent section of the further surgical implant when in use, and the further surgical implant may be, for example, an acetabular cup liner that can be positioned within the acetabular cup when in use.

[0020] The distal surface and / or the surface facing further surgical implants, or the shape of the distal portion, can be angled to accommodate the curved portion of further surgical implants such as acetabular cups and / or acetabular cup liners. The distal portion may be convex or concave.

[0021] Further surgical implant-facing surfaces may be further surgical implant-contacting surfaces.

[0022] The distal portion of the insert may include the outline of a first cross-section in a plane. The proximal portion of the insert may define the outline of a second cross-section in a plane. The outline of the first cross-section may be larger than the outline of the second cross-section. The outline of the first cross-section may be a regular shape, such as a circle. The outline of the second cross-section may be a regular shape, potentially of the same type, such as a circle. The regular shape may be concentric, such as concentric circles. The insert may provide that the outline of the first cross-section in a plane is a circular outline. The insert may provide that the outline of the second cross-section in its plane is also a circular outline. The insert may provide that the outline of the second cross-section has a smaller diameter than the diameter of the outline of the first cross-section.

[0023] The distal portion may be wedge-shaped, for example, the distal portion of the insert may include a third cross-sectional shape in a plane perpendicular to the outlines of the first and second cross-sectional shapes, and a fourth cross-sectional shape in a plane perpendicular to the outlines of the first and second cross-sectional shapes. The outline of the third cross-section may be a regular shape, such as a triangle. The outline of the second cross-section may be a regular shape, potentially of the same type, such as a triangle. The outline of the third cross-section may be larger than the outline of the fourth cross-section.

[0024] The distal portion of the insert may further comprise a flange portion. The flange may include a distal surface and a proximal surface. The distal surface of the flange may be shaped to be complementary to the shape of adjacent sections when used with further surgical implants, such as acetabular cup liners. The proximal surface of the flange may be shaped to be complementary to the shape of adjacent sections when used with surgical implants, such as acetabular cups.

[0025] One or both of the distal surface and / or the proximal surface of the flange may be shaped to be coplanar with the outer shape of at least one section of a surgical implant, for example, a section of a surgical implant that is adjacent in use. The section of the surgical implant may be planar or may be curved, for example, may be partially hemispherical. The curvature of one or both of the distal surface and / or the proximal surface of the insert may have a radius that is greater than the radius of, for example, the section of the surgical implant.

[0026] The proximal surface of the insert may be shaped to be concave with respect to a section of a surgical implant, for example, with respect to the outer shape of a section of a surgical implant that is adjacent in use. The section of the surgical implant may be planar or may be curved, for example, may be partially hemispherical.

[0027] The insert may further include a through-hole that extends between the distal surface and the proximal surface. The through-hole may be defined by a through-hole surface. The through-hole surface may include a surgical fixture contact portion. The intermediate surface may define the outer shape of a first cross-section within a plane. The through-hole surface may define the outer shape of a second cross-section within its plane. The second outer shape may be within the first outer shape.

[0028] At least a portion of the insert may be formed of a deformable material. The deformable material may have a first pre-deformed state for the through-hole surface and a first post-deformed state for the through-hole surface. The shape of the through-hole surface may be different in the first post-deformed state from the shape of the through-hole surface in the first pre-deformed state. The through-hole surface in the first post-deformed state may be adapted to engage with one or more surfaces of a surgical fixture. The through-hole surface may include a bone-engaging surgical fixture contact portion.

[0029] The insert may provide that the through-hole surface includes a bone-engaging surgical fixture contact portion. The contact portion may be provided by deformation of the through-hole surface and / or by threads provided by the through-hole surface and / or by a surgical fixture that cuts threads into the through-hole surface.

[0030] At least a portion of the insert may be formed of a deformable material, the deformable material having a second pre-deformation state for the intermediate surface. The deformable material may have a second post-deformation state for the intermediate surface. The shape of the intermediate surface in the second post-deformation state may differ from the shape of the intermediate surface in the second pre-deformation state. For example, the shape of the intermediate surface may be deformed to engage with a surgical implant opening, for example, one or more of its contact surfaces, for example, its through-hole. The insert may provide that the through-intermediate surface in the second post-deformation state is adapted to engage with one or more surfaces of the surgical implant opening. One or more surfaces may include, or may include, a surface defining the surgical implant opening, a surface defining the through-hole in the surgical implant, the distal surface of the surgical implant, and the proximal surface of the surgical implant.

[0031] The surface of the through-hole may, for example, be a tapered hole having screw threads.

[0032] The outer shape of the first cross-section in the plane of the intermediate surface may be circular. The outer shape of the second cross-section in the plane of the through-hole surface is circular and may have a smaller diameter than the outer shape of the first cross-section.

[0033] The cross-sectional shape of the second cross-section may decrease along the axis of the through-hole, for example, due to a taper of the hole from the distal end to the proximal end. The cross-sectional shape of the first cross-section may decrease along the axis of the through-hole, for example, due to a taper of the intermediate surface over a portion of the transition from the distal end to the proximal end. The intermediate surface may have the largest first cross-sectional shape at the distal surface. The intermediate surface may have the smallest first cross-sectional shape at the proximal surface. The intermediate surface may have the smallest first cross-sectional shape from the intermediate position to the proximal surface to provide, for example, a cylindrical portion. The intermediate surface may transition from the largest cross-sectional shape to the smallest cross-sectional shape to provide a curved intermediate surface, for example, a bowl-shaped cross-section.

[0034] The insert may be a 3D printed insert. The insert may be 3D printed together with one or more other components, such as a surgical implant opening and / or a surgical implant.

[0035] The first aspect of this disclosure may include any of the features, options, or possibilities set out elsewhere in this specification, including descriptions of other aspects and embodiments.

[0036] According to a second aspect of this disclosure, a surgical kit is provided, the kit is, One or more surgical implant opening inserts, Including a main body portion, the main body portion provides a distal surface and a proximal surface, and the main body portion further provides an intermediate surface extending between the distal surface and the proximal surface. The proximal portion of the intermediate surface includes the surgical implant opening contact portion. A distal portion of the intermediate surface is provided, which is located distal to and extends beyond the surgical implant contact portion, and the distal portion of the intermediate surface provides the cement contact portion. The distal surface includes one or more surgical implant opening inserts, the distal surface of which is a portion opposed to a further surgical implant. The kit further includes one or more surgical implants, at least one of which includes at least one surgical implant opening.

[0037] The surgical implant may also be an orthopedic implant. The surgical implant may be one or more of the following: an acetabular shell, a partial acetabular shell, an acetabular shell liner, or an acetabular cage.

[0038] A surgical implant, for example, its surgical implant opening, may include a threaded insert retaining element.

[0039] A surgical implant may include at least one surgical implant opening that is a through hole and at least one surgical implant opening that is a blind hole. The surgical implant may include a grid of blind hole surgical implant openings.

[0040] The surgical kit may further include one or more additional surgical implants, for example, different types and / or the same type of surgical implants in different sizes. For example, the surgical kit may further include one or more acetabular cup liners of different sizes. When in use, the liner may be inserted, for example, into the acetabular cup, thereby preventing the insert inserted into the opening of the acetabular cup from directly contacting the liner with the acetabular cup. The insert provides space between the surgical implant and any additional surgical implants where cement may be placed, and this space is the minimum cement mantle.

[0041] The surgical kit may further include one or more surgical fixation devices, such as one or more screw fixation devices, such as one or more non-locking fixation devices and / or one or more locking fixation devices. Two or more different types and / or different sizes of surgical fixation devices may be provided.

[0042] The kit includes at least two surgical implant opening inserts, each containing a distal portion of the surgical implant that is shaped to be complementary to the external shape of different portions of adjacent sections when in use.

[0043] The kit may include a first surgical implant opening insert having a distal portion with an axial range, e.g., height, and a second surgical implant opening insert having a distal portion with an axial range, e.g., height, and the axial range, e.g., height of the first surgical implant opening insert may be greater than the axial range, e.g., height of the second surgical implant opening insert. The kit may include a variety of inserts with different axial ranges, e.g., height. The axial range, e.g., height, may be in the range of 1 mm to 7 mm. The kit may include a variety of inserts with different axial ranges, e.g., height, suitable for insertion into blind hole surgical implant openings, and / or the kit may include a variety of inserts with different axial ranges, e.g., height, suitable for insertion into through-hole surgical implant openings.

[0044] The kit may include a first surgical implant opening insert having a distal portion molded to complement a specific area of ​​the surgical implant surface, and a second surgical implant opening insert having a distal portion molded to complement a different specific area of ​​the surgical implant surface. The kit may include a variety of inserts having various different shapes to accommodate, for example, surgical implants with angled surfaces. The variety of inserts may include inserts having cement contact portions of different shapes. Different shapes may be used by the surgeon to distinguish inserts of different sizes, and size may refer to different axial ranges of the insert, such as height.

[0045] The kit may include one or more surgical implants, each containing at least one stop surgical implant opening for use with various inserts.

[0046] A second aspect of this disclosure may include any of the features, options, or possibilities set out elsewhere in this specification, including descriptions of other aspects and embodiments.

[0047] According to a third aspect of the present disclosure, an orthopedic implant system is provided which includes one or more orthopedic implants and one or more surgical implant opening inserts according to any part of the first aspect, wherein at least one of the orthopedic implants includes at least one surgical implant opening.

[0048] Orthopedic implant systems are a. One or more orthopedic implants include a first orthopedic implant having a concave inner surface, a convex outer surface located opposite the concave inner surface, and at least one surgical implant opening extending between the concave inner surface and the convex outer surface, wherein the at least one surgical implant opening extends over the length between the concave inner surface and the convex outer surface, and / or b. The surgical implant opening insert may have an axial length greater than the length of at least one surgical implant opening, thereby providing that when the surgical implant opening insert is connected to the first orthopedic implant, the surgical implant opening insert extends beyond the concave inner surface in an axial range or height, and that the axial range or height defines the minimum cement mantle thickness.

[0049] The orthopedic implant system may further include a second orthopedic implant having a convex outer surface. a. The concave inner surface of the first orthopedic implant defines a cavity of a size that accommodates the second orthopedic implant, and / or b. The convex outer surface of the second orthopedic implant is sized to engage with a cement mantle positioned on the concave inner surface of the first orthopedic implant, which has the minimum cement mantle thickness.

[0050] A third aspect of this disclosure may include any of the features, options, or possibilities set out elsewhere in this specification, including descriptions of other aspects and embodiments.

[0051] A fourth aspect of this disclosure provides a method for fitting a surgical implant opening to create a minimum cement mantle, the method being provided. a) Selecting a surgical implant opening insert for insertion into the surgical implant opening of the first surgical implant, b) Inserting a surgical implant opening insert into the surgical implant opening, c) Apply the cement to the surgical implant so that the cement is level with the distal surface of the insert. d) Inserting a further surgical implant into the first surgical implant, wherein the insert is Including a main body portion, the main body portion provides a distal surface and a proximal surface, and the main body portion further provides an intermediate surface extending between the distal surface and the proximal surface. The proximal portion of the intermediate surface includes the surgical implant opening contact portion. A distal portion of the intermediate surface is provided, which is located distal to and extends beyond the surgical implant contact portion, and the distal portion of the intermediate surface provides a cement contact portion. The distal surface is the portion that faces further surgical implants.

[0052] This method, a) One or more surgical implant opening inserts corresponding to the minimum cement mantle required for a specific surgical procedure, b) One or more surgical implant opening inserts corresponding to the specific external shape of one or more surgical implants, c) One or more surgical implant openings that accept an insert but do not accept a surgical fixation device, d) One or more surgical implant openings for receiving a first size or first type of fixation device for insertion into an insert within a surgical implant opening, e) This may include selecting one or more surgical implant openings for receiving a second size or second type of fixation device, for example, for insertion into a surgical implant opening lacking an insert.

[0053] The method may include the first surgical implant comprising one or more through-hole surgical implant openings and one or more blind-hole surgical implant openings.

[0054] This method may include providing multiple blind foramen surgical implant openings, and having the multiple blind foramen surgical implant openings arranged in a grid pattern.

[0055] This method may include selecting one or more through-hole surgical implant openings for receiving an insert. This method may include selecting one or more blind-hole surgical implant openings for receiving an insert. This method may include selecting a combination of through-hole surgical implant openings and blind-hole surgical implant openings for receiving an insert.

[0056] The method may include providing an insert that is at least a portion of an insert formed from a porous material. The method may also include selecting an insert having a specific porosity that is suitable for optimal cement interlocking.

[0057] The method may include providing an insert that further provides a distal portion which is a flange portion. The method may include selecting an insert having a flange formed to be complementary to the external shape of adjacent sections of a surgical implant, and a proximal surface of the flange formed to be complementary to the external shape of adjacent sections of different surgical implants.

[0058] The method may further provide that the insert has an intermediate surface that defines the outline of a first cross-section in a plane, and a through-hole surface that defines the outline of a second cross-section in that plane, with the second outline being within the first outline.

[0059] The method may include providing an insert that is formed of a deformable material, at least a portion of the insert. The method may include a deformable material that is deformed by engagement with a surgical fixation device and / or by insertion of the insert into a surgical implant opening.

[0060] The method may further include the insert providing a through-hole surface that engages with one or more surfaces of a surgical fixation device.

[0061] The method further includes providing an insert that comprises at least a portion of an insert 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 further may provide that the shape of the through-hole surface in the first post-deformation state is different from the shape of the through-hole surface in the first pre-deformation state. The difference in shape may be caused by engagement of a surgical fixation device with the deformable material and / or insertion of a surgical fixation device into the through-hole.

[0062] This method may provide that the surface of the through-hole includes a contact portion for a bone-engagement surgical fixation device.

[0063] This method may provide that the insert includes a cement contact portion, and a first insert of a first size has a cement contact portion with a different shape from that of a second insert of a second size.

[0064] The method may further provide that the insert provides at least a portion of an 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 may further provide that the shape of the intermediate surface in the second post-deformation state is different from the shape of the intermediate surface in the second pre-deformation state. The difference in shape may be caused by engagement of the deformable material with the surgical implant opening and / or insertion of the insert into the surgical implant opening.

[0065] The deformable material may be polymethyl methacrylate (PMMA) cement. The PMMA insert may be 3D printed or injection molded.

[0066] The method may further provide that the insert provides a second deformed intermediate surface that engages with one or more surfaces of the surgical implant opening.

[0067] A fourth aspect of this disclosure may include any of the features, options, or possibilities described elsewhere in this specification, including descriptions of other aspects and embodiments.

[0068] According to a fifth aspect of the present invention, a method for implanting a first surgical implant and a further surgical implant is provided, the method is a) Selecting a first surgical implant, wherein the first surgical implant has at least one surgical implant opening, b) Implanting the first surgical implant into the patient's surgical site, c) Selecting a surgical implant opening insert for insertion into the surgical implant opening of the first surgical implant, d) Inserting a surgical implant opening insert into the surgical implant opening of the first surgical implant, e) Applying cement to the first surgical implant, f) Inserting a further surgical implant into the first surgical implant in order to implant a further surgical implant into the patient's surgical site, The insert is Including a main body portion, the main body portion provides a distal surface and a proximal surface, and the main body portion further provides an intermediate surface extending between the distal surface and the proximal surface. The proximal portion of the intermediate surface includes the surgical implant opening contact portion. A distal portion of the intermediate surface is provided, which is located distal to and extends beyond the surgical implant contact portion, and the distal portion of the intermediate surface provides a cement contact portion. The distal surface is the portion that faces further surgical implants.

[0069] In the implantation method, step e) provides applying cement to the first surgical implant so that the cement is flush with the distal surface of the insert. The implantation method wherein the surgical implant opening creates a minimum cement mantle between the first and second surgical implants.

[0070] The implantation method may provide that steps c) and / or d) are provided before step b). The implantation method may provide that steps c) and / or d) are provided after step b). The implantation method may provide that step e) is applied to the first surgical implant before step b). The implantation method may provide that step e) is applied to the first surgical implant after step b).

[0071] The method of planting is, a) One or more surgical implant opening inserts corresponding to the minimum cement mantle required for a specific surgical procedure, b) One or more surgical implant opening inserts corresponding to the specific external shape of one or more surgical implants, c) One or more surgical implant openings that accept an insert but do not accept a surgical fixation device, d) One or more surgical implant openings for receiving a first size or first type of fixation device for insertion into an insert within a surgical implant opening, e) This may include using one or more surgical implant openings for receiving a second size or second type of fixation device for insertion into a surgical implant opening lacking an insert, for example.

[0072] The implantation method may include the first surgical implant comprising one or more through-hole surgical implant openings and one or more blind-hole surgical implant openings.

[0073] The implantation method may include providing multiple blind-hole surgical implant openings, and having the multiple blind-hole surgical implant openings arranged in a grid pattern.

[0074] The implantation method may include providing one or more inserts within one or more through-hole surgical implant openings. The implantation method may include providing one or more inserts within one or more blind-hole surgical implant openings for receiving the inserts. The implantation method may include providing one or more inserts in a combination of through-hole surgical implant openings and blind-hole surgical implant openings.

[0075] The implantation method may include the use of one or more inserts that provide at least a portion of an insert formed of a porous material. The implantation method may include the use of one or more inserts having a specific porosity adapted to optimal cement interlocking.

[0076] The implantation method may include using one or more inserts that further provide a distal portion which is a flange portion. The implantation method may include using one or more inserts having a flange formed to be complementary to the external shape of adjacent portions of a surgical implant, and a proximal surface of a flange formed to be complementary to the external shape of adjacent portions of different surgical implants.

[0077] The implantation method may include using one or more inserts, the intermediate surface defining the outline of a first cross-section in a plane, the through-hole surface defining the outline of a second cross-section in its plane, and further providing that the second outline is within the first outline.

[0078] The implantation method may include using one or more inserts that provide at least a portion of an insert formed of a deformable material. The implantation method may include using a deformable material that is deformed by engagement with a surgical fixation device and / or by insertion of an insert into a surgical implant opening.

[0079] The implantation method may further include using one or more inserts that provide through-hole surfaces that engage with one or more surfaces of a surgical fixation device.

[0080] The implantation method may further include using one or more inserts that provide at least a portion of an insert 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 implantation method may further provide that the shape of the through-hole surface in the first post-deformation state is different from the shape of the through-hole surface in the first pre-deformation state. The difference in shape may be caused by engagement of a surgical fixation device with the deformable material and / or insertion of a surgical fixation device into the through-hole.

[0081] The implantation method may involve using one or more inserts, the through-hole surface of which includes a bone engagement surgical fixation device contact portion.

[0082] The planting method may involve using one or more inserts, wherein the insert includes a cement contact portion, and a first insert of a first size has a cement contact portion of a different shape than a second insert of a second size.

[0083] The implantation method may use one or more inserts, each providing at least a portion of an insert formed of a deformable material, the deformable material further having a second pre-deformation state for the intermediate surface and a second post-deformation state for the intermediate surface. The implantation method may use one or more inserts, each providing that the shape of the intermediate surface in the second post-deformation state is different from the shape of the intermediate surface in the second pre-deformation state. The difference in shape may be caused by engagement of the deformable material with the surgical implant opening and / or by insertion of the insert into the surgical implant opening.

[0084] The implantation method may involve using a deformable material, which may be polymethyl methacrylate (PMMA) cement. The PMMA insert may be 3D printed or injection molded.

[0085] The implantation method may involve using one or more inserts, further providing that the insert provides a second post-deformed intermediate surface that engages with one or more surfaces of the surgical implant opening.

[0086] A fifth aspect of this disclosure may include any of the features, options, or possibilities described elsewhere in this specification, including descriptions of other aspects and embodiments. [Brief explanation of the drawing]

[0087] Embodiments of the present disclosure are described below, so to speak, by reference to the accompanying drawings, where similar reference numerals in the drawings relate to similar elements. [Figure 1] This disclosure shows various surgical implants that are useful. [Figure 2a] This is a side view of the insert according to the first embodiment. [Figure 2b] Figure 2a is a cross-sectional view of the insert. [Figure 3] This is a diagram of a further embodiment of the present disclosure in which different parts of the insert are formed of different materials. [Figure 4]This is a cross-sectional elevation view of one embodiment of an insert, shown inserted into a through-hole in the acetabular shell. [Figure 5] This is a cross-sectional view of one embodiment of an insert, shown inserted into a through-hole of an acetabular shell having a liner (cement not shown) fixed in place with cement. [Figure 6] This is a perspective view of an acetabular cup having an insert of the first embodiment inserted into a screw hole in the acetabular shell. [Figure 7a] These are diagrams of various sizes and types of fasteners that can be used in conjunction with this disclosure. [Figure 7b] These are diagrams of various sizes and types of fasteners that can be used in conjunction with this disclosure. [Figure 8] This is a diagram of an acetabular cup having an inserted insert and a locking screw screwed into the through-hole of the insert. [Figure 9a] This is a cross-sectional view of the acetabular shell, including a blind-hole surgical implant opening in addition to a through-hole surgical implant opening. [Figure 9b] These are cross-sectional views of three different insert shapes, each shown inserted into the blind foramen surgical implant opening of the acetabular shell in Figure 9a. [Modes for carrying out the invention]

[0088] Referring to the drawings, Figure 1 shows a series of perspective views of examples of surgical implants, which are an acetabular revision cage 2, a partial acetabular cup 4, and an acetabular cup 6. Each of these surgical implants 2, 4, and 6 has a number of through-holes 8 for accommodating fixation devices (not shown) when in use. In most surgical cases, only a few of the through-holes 8 are used, and the other through-holes 8 are left as open through-holes 8.

[0089] These are just a few examples of the wide variety of surgical implants to which this disclosure relates. For example, this disclosure can be used in surgical implants where a minimal cement mantle is required between two components, such as an acetabular cup and a liner 70. The minimum cement mantle ranges from 1 mm to 7 mm, depending on the type and location of the implant.

[0090] Figure 2a provides a side perspective view of one embodiment of an insert 20, described in reference to the use of an acetabular joint. The insert 20 includes a body portion 22 having a distal surface 24, the distal surface 24 having a distal opening 26 located at the distal end of a through hole 28, the through hole 28 extending through the body portion 22 to a proximal opening 30 provided on the proximal surface 32 of the body portion 22. See Figure 2b.

[0091] The insert 20 is suitable for insertion into through-holes 8 of various surgical implants, such as acetabular shells, component shells, or cages.

[0092] To retain the insert 20 within the surgical implants 2, 4, and 6, at least the outer diameter d1 of section S of the insert 20 is in an interlocking fit with a complementary section of the surgical implants 2, 4, and 6. This section may be a different section from the illustrated section S, or it may be the entire outer shape of the outer surface 34. This retention provides a first level of retention of the insert 20 relative to the surgical implants 2, 4, and 6. Further, increased levels of retention are described below.

[0093] The main body portion 22 of the insert 20 includes a proximal portion 21 and a distal portion 23, as shown in Figure 4. The total height of the main body portion 22 is greater than the height of the through-hole 8 of the surgical implants 2, 4, 6, so that when the implants are held within the implants 2, 4, 6, the distal portion 23 of the insert 20 protrudes from the distal surface 50 around the acetabular cup 6, as shown in Figure 4. The proximal portion 21 of the insert 20 has a height h1 that includes the height of the complementary portion of the surgical implants 2, 4, 6. The distal portion 23 of the insert 20 has a height h2 that provides the minimum cement mantle thickness when the liner 70 is positioned inside the surgical implants 2, 4, 6 and in contact with the distal surface 24. A typical height of the distal portion 23 would be, for example, 1 mm to 7 mm beyond the inner surface of the shell.

[0094] The minimum cement mantle thickness is the minimum space required between the first and second surgical implants, which will be filled with cement for fixation, stability, and strength. If the cement mantle is too thin, the durability and fixation strength of the prosthesis may be reduced, while if it is too thick, the risk of heat-induced osteonecrosis may increase.

[0095] The insert 20 is formed from a porous material to enable cement interlocking. Cement interlocking is the penetration of cement into the bone or implant. The depth of interlocking depends on factors such as the porosity of the bone or implant, the viscosity of the bone cement, and the temperature and humidity of the surgical environment. Porous materials can promote bone growth, for example, on the proximal surface.

[0096] In this embodiment, the entire body portion 22 is formed from a porous material to facilitate cement interlocking. Therefore, providing the insert 20 in the through-hole 8 within the surgical components 2, 4, and 6 has the advantage of increasing the surface area of ​​the surgical components 2, 4, and 6 available for cement interlocking. Beyond its role in defining the minimum cement mantle thickness, the insert 20 can be largely used to fill the through-hole 8 without further use of the insert 20, and the minimum cement mantle thickness is shown in Figure 4, corresponding to the height in parentheses of the distal portion 23 projecting above the surgical component 6.

[0097] In the embodiment shown in Figure 3, the main body portion 22 of the insert is formed from different materials in different regions. For example, the outer volume 60 of the main body portion 22 may be formed from a porous material to facilitate cement interlocking, and the inner volume 62 of the main body portion 22, which may contain through-holes 28, may be formed from a different material optimized for deformation, for example. The different material may be a non-porous material or a porous material having different properties from the porous material of the outer volume 60. In any of the embodiments of the insert 20, the material from which it is constructed may also be deformable during surgical use. This deformability may apply to the entire insert 20.

[0098] As shown in Figures 4 and 6, the insert 20 is positioned within an opening, such as a through-hole 8, of a surgical implant in the form of an acetabular cup 6.

[0099] The shape of the insert 20 is molded such that its distal surface 24 is complementary to the proximal surface 71 of the cement liner 70, as shown in Figure 5. In this way, the distal portion 23 of the insert 20 provides the smallest cement mantle that does not interfere with the seating of the liner 70 during use.

[0100] In the example shown in Figure 5, the distal surface 24 of the main body portion 22 is concave such that the curved portion of the liner 70 is complementary to the distal surface 24 of the main body portion 22 when the insert 20 is positioned in the through hole 8 and the liner 70 is positioned on top.

[0101] The height h2 of the distal portion 23 may vary so that different minimum cement mantle thicknesses can be selected to suit the surgical procedure. In some examples, each insert 20 positioned within the through-hole 8 of the surgical implant has a single height, thereby ensuring that the same minimum cement mantle thickness, e.g., 2 mm, is present across the surface of the liner 70 when the liner 70 is positioned on top.

[0102] Alternatively, inserts 20 having different heights can be used to vary the minimum cement mantle thickness around the surface of the surgical implant, resulting in a structure with an eccentric bearing and shell center that reduces the incidence of transposition and / or reduces joint pain.

[0103] For example, inserts 20 of different heights can bias the liner 70, for instance, 1 mm downward or 7 mm upward, to change the head center relative to the cup. In this example, the head center would be changed by 3 mm relative to the cup.

[0104] The inserts 20 may also be used to alter the joint tension. For example, if an insert 20 that yields a minimum cement mantle of 7 mm is inserted into the pole, and an insert 20 that yields a minimum cement mantle of 2 mm is inserted into the through-hole 8 around the surgical implant, the effect is to orient the bearing laterally, which will increase the joint tension.

[0105] As shown in Figure 6, the through-hole 8 of the surgical implant 6 is tapered. Therefore, the main body portion 22 of the insert 20 may have a shape complementary to the corresponding taper and through-hole 8, so that when inserted, at least the proximal portion 21 of the insert 20 fills the through-hole 8.

[0106] Insert 20 can also function as an adapter that allows a different size and / or type of fixation device, which would normally work directly with the surgical implants 2, 4, 6 by being inserted into the through-hole 8 in the absence of any insert 20, to work with the insert 20, and therefore with the surgical implants 2, 4, 6. As shown in Figure 4, the through-hole 28 has a diameter d2 smaller than the diameter of the through-hole 8 of the surgical devices 2, 4, 6, which is equal to the outer diameter d1 of the insert 20 plus tolerance. A typical diameter of d2 is, for example, 2 mm to 3.5 mm.

[0107] A through-hole 8 without insert 20 can reliably receive a fixation device having an outer diameter matching d1, but with insert 20 present, the through-hole 28 allows smaller diameter fixation devices, such as locking screws, to reliably engage with the through-hole 8 and therefore with the surgical implants 2, 4, 6. This provides a second enhanced level of retention. This means that a surgeon can select from a set of such through-holes 8 which are best suited to receiving larger sizes or first types of fixation devices, which are best suited to receiving smaller sizes or second types of fixation devices and should therefore have insert 20, and which do not need to have a fixation device but are provided with insert 20 to provide the minimum cement mantle across the surface of the implant 6. The surgeon may still select several through-holes 8 to receive either a fixation device or insert 20. This flexibility of selection allows for the provision of the minimum cement mantle across the surface of the implant, good stability for the implant, the optimal size and / or type of fixation device to be used, and the maximum cement-to-cement mating that is facilitated.

[0108] In some embodiments not shown, the through-hole 28 does not have threads. In this configuration, the threads of the fastener, such as a locking screw, may be self-tapping screws, or threads may be cut into the side wall 36 of the hole to secure the fastener to the insert 20.

[0109] In other configurations not shown, the through-hole 28 may include threads formed in its side wall 36 along at least a portion of its length. Similarly, in other configurations not shown, the threads may only extend partway along the length of the side wall 36. The threads are complementary to the threads of the fastener.

[0110] Figure 2b shows the threads 36 formed along the entire length of the side wall 38. The threads 36 in Figures 2a and 2b have a constant diameter and are complementary to the male threads of a fastener such as a locking screw. When the fastener, in this case a locking screw, is screwed in through the through hole 28 of the insert 20, the locking screw deforms the porous material on which the insert 20 is formed, and as a result the head of the locking screw 22 is trapped within the deformed material, locking the insert 20 into place with respect to both the locking screw and the surgical implant 6.

[0111] In the embodiment shown in Figure 4, as described above in 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 this case the diameter for receiving the fixation device is narrowed to the diameter d2 of the through-hole 28. In this embodiment, the diameter is reduced to a minimum value d3 by the taper of the through-hole 28 from distal to proximal. When the fixation device, in this case a locking screw, is screwed through the through-hole 28 of the insert 20, the locking mechanism deforms the porous material on which the insert 20 is formed, and as a result the head of the locking screw 22 is trapped within the deformed material, locking the insert 20 into place in both the locking screw and the surgical implant 6.

[0112] Figure 7a shows a typical fixation device 40 for direct cooperation with surgical implants 2, 4, and 6.

[0113] Figure 7b shows a fixed fixture 42 with a reduced diameter compared to the typical fixation in Figure 7a, for use with the insert 20 as an adapter and thus with the surgical components 2, 4, and 6. 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 as the fixed fixture is inserted. The deformation is controlled by the structure, porosity, and density of the material of the insert 20. Both fixed fixtures 42 are shown partially inserted and therefore still protruding above the distal surface 24. When fully inserted, the distal ends of the fixed fixtures 42 are either coplanar with the distal surface 42 of the insert 20 or recessed relative to the distal surface 42.

[0114] Figure 8 shows a surgical implant 6 with two inserts, in which insert 20 is inserted and a locking screw 42 is screwed into the through hole 28 of insert 20. When the head of the locking screw 42 enters the distal end of the hole 28, the hole 28 and the surrounding portion of the distal surface 42 deform to adapt to and allow for the coplanar or recessed positioning of the head of the fixation device 42.

[0115] Figure 9a shows a surgical implant 10, such as a partial acetabular cup or acetabular cup. These are just some examples of the wide variety of surgical implants to which this disclosure relates. For example, this disclosure can be used for surgical implants where a minimum cement mantle is required between two components, such as an acetabular cup and a liner 70. The minimum cement mantle ranges from 1 mm to 7 mm, depending on the type and location of the implant.

[0116] Similar to the surgical devices described above, the surgical implant 10 shown in the embodiment of Figure 9a has a number of through-holes 8 for accommodating fixation devices (not shown) when in use. In most surgical cases, only a few of the through-holes 8 are used, and the others are left as open through-holes 8. In addition to the through-holes 8, the surgical implant 10 also has several surgical implant openings 80. At least some of the surgical implant openings 80 are blind holes that do not penetrate the entire thickness of the implant 10.

[0117] In some embodiments, the blind-hole surgical implant openings 80 are evenly spaced across the surface of the surgical implant 10. In some embodiments, the blind-hole surgical implant openings 80 are distributed to form a grid across the surface of the surgical implant 10. For example, the grid may consist of two or more levels, with at least four or more blind-hole surgical implant openings 80 evenly spaced around the implant 10 at each level.

[0118] As shown in Figure 9a, the blind-hole surgical implant openings 80 are the same diameter, although they may be different. As shown in Figure 9a, the surgical implant openings 80 have a diameter equal to the outer diameter of the surgical implant opening contact portion of inserts 20a and 20c plus a tolerance. Typical diameters, as just an example, would be 2 mm to 3.5 mm. Insert 20b includes a tapered surgical implant opening contact portion. In some examples, the surgical implant openings 80 are tapered (not shown).

[0119] As described above, inserts 20a, 20b, and 20c provide a distal portion having an axial range or height h2 that provides space above the distal surface around the surgical implant to set the minimum cement mantle thickness when in use. The distal portion is the cement contact portion. Figure 9a shows inserts 20a, 20b, and 20c having cement contact portions of different shapes. Different shapes may be used by surgeons to distinguish inserts of different sizes. For example, insert 20a has a distal portion with an axial range, e.g., height, and insert 20b has a distal portion with an axial range, e.g., height that is greater than the axial range, e.g., height of insert 20a. Similarly, the axial range, e.g., height of insert 20c is greater than the axial range, e.g., height of inserts 20b and 20a.

[0120] At least a portion of the inserts 20a, 20b, and 20c may be formed of a deformable material. The deformable material may be selected and / or adapted to deform upon engagement of the surgical implant with the surgical implant opening 80. The deformable material may be PMMA. Alternatively, or additionally, at least a portion of the inserts 20a, 20b, and 20c may include a slit (not shown) perpendicular to the axis of the insert to facilitate deformation when inserting the inserts 20a, 20b, and 20c into the surgical implant opening 80.

[0121] In the embodiment shown in Figure 9a, the surgeon can select from a full set of such through-holes 8: those blind surgical implant openings 80 that are best suited and sized to receive inserts 20a, 20b, and 20c; those through-holes 8 that are best suited to receive larger sizes or first-type fixators, and those that are best suited to receive smaller sizes or second-type fixators and should therefore have inserts 20; and those through-holes 8 that do not require a fixator but are provided with inserts 20 to provide minimal cement mantle across the surface of the implant 6. The surgeon may still select several through-holes 8 and / or blind surgical implant openings 80 that do not receive fixators or inserts 20, 20a, 20b, and 20c. This flexibility of selection allows for minimal cement mantle across the surface of the implant, good stability for the implant, the optimal size and / or type of fixator used, and the provision of maximum cement interlocking facilitated.

[0122] The insert 20 in any of the embodiments may be 3D printed. The insert 20 may be 3D printed so that it is already in situ within the through-hole 8 of the surgical implants 2, 4, and 6, or it may be separately inserted into a particular through-hole 8.

[0123] The disclosure also relates to a method for adapting through-holes 8 in a surgical device to create a minimum cement mantle. The method further includes the step of adapting the through-holes 8, which are suitable for a first size or type of fastener such as a non-locking screw, to be suitable for a second size or type of fastener such as a locking screw. The method includes first providing a surgical implant including through-holes 8 for, for example, a non-locking screw hole, and then providing an insert 20 according to one of the examples provided above. The insert 20 is then inserted into one of the through-holes 8 and the liner 70 is cemented into place. If it is preferred to use a second type of fastener before the liner 70 is cemented into place, an additional step includes inserting the second type of fastener, for example a locking screw, into the through-hole 28 of the insert 20 and then cementing the liner 70 into place.

[0124] This disclosure also relates to a method for fitting a blind hole surgical implant opening in a surgical device to create a minimum cement mantle. The method further includes the step of fitting a through hole 8 in a surgical device suitable for a first size or type of fastener, such as a non-locking screw, to be suitable for a second size or type of fastener, such as a locking screw. The method includes first providing a surgical implant including a blind hole surgical implant opening 80, and then providing inserts 20, 20a, 20b, 20c according to one of the examples provided above. Next, the inserts 20, 20a, 20b, 20c are inserted into one of the surgical implant openings 80, and the liner 70 is cemented into place. If the surgical implant also includes a through hole 8 for, for example, a non-locking screw hole, it may be preferable to use a second type of insert before the liner 70 is cemented into place. An additional step includes providing insert 20 according to one of the examples provided above. Next, the insert 20 is inserted into one of the through holes 8, and the liner 70 is cemented into place. If it is preferable to use a second type of fastening before the liner 70 is cemented into place, a further additional step includes inserting a second type of fastening, such as a locking screw, into the through hole 28 of the insert 20, and then cementing the liner 70 into place.

[0125] A kit is also provided for fitting the through-hole 8 to create the smallest possible cement mantle between the implant and the liner 70. The kit includes at least two inserts 20 with the aforementioned inserts, and at least two different types of fasteners.

[0126] A kit is also provided for creating a minimum cement mantle between the implant and the liner 70. The kit includes a surgical implant with a blind hole surgical implant opening and at least two inserts 20, 20a, 20b, 20c with the inserts described above. The kit may include inserts 20a, 20b, 20c having different axial ranges or heights to vary the thickness of the minimum cement mantle. The kit may further include at least two inserts 20 with the inserts described above and at least two different types of fixation for fitting the through hole 8 to create a minimum cement mantle between the implant and the liner 70.

[0127] While specific embodiments of this disclosure have been described, it will be understood that many modifications, additions, and / or substitutions are possible within the claims. Various modifications and alternative forms are conceivable for the concepts of this disclosure, specific embodiments of which are illustrated in the drawings and described in detail herein. However, it should be understood that it is not the intention of this disclosure to limit the concepts to the specific forms disclosed, but rather to encompass all modifications, equivalents, and alternatives included in this disclosure and the attached "Claims."

[0128] [Implementation Method] (1) A surgical implant opening insert, Including a main body portion, the main body portion provides a distal surface and a proximal surface, and the main body portion further provides an intermediate surface extending between the distal surface and the proximal surface, The proximal portion of the intermediate surface includes the surgical implant opening contact portion, A distal portion of the intermediate surface is provided, which is located distal to and extends beyond the surgical implant contact portion, and the distal portion of the intermediate surface provides a cement contact portion. A surgical implant opening insert, wherein the distal surface is a further surgical implant-opposing support portion. (2) The surgical implant opening insert according to Embodiment 1, wherein the proximal portion has an axial range or height h1 which is at least the same as the axial range or height of the surgical implant opening, and the distal portion has an axial range or height h2 which provides space above the distal surface around the surgical implant to set the minimum cement mantle thickness when in use. (3) The surgical implant opening insert according to Embodiment 1 or 2, wherein at least a portion of the insert is formed of a porous material, and the porous material is adapted to facilitate cement interlocking. (4) A surgical implant opening insert according to any one of embodiments 1 to 3, wherein a first portion of the main body is formed of a first material, and a second portion of the main body is formed of a second material, and the first material and the second material differ from each other in their porosity and / or deformability. (5) The surgical implant opening insert according to any one of embodiments 1 to 4, wherein the distal portion is formed of a material having higher porosity than the proximal portion.

[0129] (6) The surgical implant opening insert according to any one of embodiments 1 to 5, wherein the distal surface is shaped to be complementary to the shape of adjacent sections of the surgical implant when in use. (7) A surgical implant opening insert according to any one of embodiments 1 to 6, wherein the distal portion defines the outline of a first cross-section in a plane, the proximal portion defines the outline of a second cross-section in a plane, and the outline of the first cross-section is larger than the outline of the second cross-section. (8) A surgical implant opening insert according to any one of embodiments 1 to 7, wherein the distal portion is a flange portion, the flange has a distal surface and a proximal surface, the distal surface of the flange is shaped to be complementary to the shape of an adjacent portion of a further surgical implant when in use, and the proximal surface of the flange is shaped to be complementary to the shape of an adjacent portion of the surgical implant when in use. (9) Further comprising a through hole extending between the distal surface and the proximal surface, wherein the through hole is defined by the through hole surface, The surface of the through-hole includes the portion that comes into contact with the surgical fixation device. A surgical implant opening insert according to any one of embodiments 1 to 8, wherein the intermediate surface defines the outline of a first cross-section within a plane, and the through-hole surface defines the outline of a second cross-section within that plane, and the second outline is located within the first outline. (10) A surgical implant opening insert according to any one of embodiments 1 to 9, wherein at least a portion of the insert is 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, and the shape of the through-hole surface in the first post-deformation state is different from the shape of the through-hole surface in the first pre-deformation state.

[0130] (11) The surgical implant opening insert according to Embodiment 9, wherein the through-hole surface in the first deformed state is adapted to engage with one or more surfaces of a surgical fixation device. (12) The surgical implant opening insert according to any one of embodiments 1 to 11, wherein the through-hole surface includes a bone engagement surgical fixation device contact portion. (13) A surgical implant opening insert according to any one of embodiments 1 to 12, wherein at least a portion of the insert is 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 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. (14) The surgical implant opening insert according to Embodiment 13, wherein the intermediate surface in the second deformed state is adapted to engage with one or more surfaces of a surgical implant opening. (15) A surgical implant opening insert according to any one of embodiments 1 to 14, wherein the surface of the through hole is provided with threads.

[0131] (16) A surgical implant opening insert according to any one of embodiments 1 to 15, wherein the outer shape of the first cross-section in the plane of the intermediate surface is circular, and the outer shape of the second cross-section in the plane of the through-hole surface is also circular and has a diameter smaller than the diameter of the outer shape of the first cross-section. (17) A surgical implant opening insert according to any one of embodiments 1 to 16, wherein the cross-section of the outer shape of the second cross-section decreases along the axis of the through-hole, for example due to a taper of the hole from the distal end to the proximal end. (18) A surgical implant opening insert according to any one of embodiments 1 to 17, wherein the cross-section of the outer shape of the first cross-section is reduced along the axis of the through hole due to a taper of the intermediate surface over a portion of the transition from the distal end to the proximal end, for example. (19) A surgical implant opening insert according to any one of embodiments 1 to 18, wherein the insert is 3D printed. (20) A surgical kit comprising one or more surgical implant opening inserts described in any of embodiments 1 to 19, and one or more surgical implants, wherein at least one of the surgical implants includes at least one surgical implant opening.

[0132] (21) The surgical kit according to Embodiment 20, wherein the surgical implant is one or more of the following: an acetabular shell, a partial acetabular shell, an acetabular shell liner, and an acetabular cage. (22) The surgical kit according to Embodiment 20 or 21, wherein the kit includes at least two surgical implant opening inserts, each having a distal portion molded to be complementary to the external shape of different portions of adjacent sections of the surgical implant when in use. (23) The surgical kit according to any of embodiments 20 to 22, wherein the kit comprises a first surgical implant opening insert having a distal portion having an axial range and a second surgical implant opening insert having a distal portion having a second axial range, the first axial range being greater than the second axial range. (24) The surgical kit according to any one of embodiments 20 to 23, wherein the kit further comprises one or more surgical fixation devices. (25) The surgical kit according to any one of embodiments 20 to 23, wherein one or more surgical implants include at least one blind hole surgical implant opening.

[0133] (26) An orthopedic implant system comprising one or more surgical implant opening inserts according to any of Embodiments 1 to 19 and one or more orthopedic implants, wherein at least one of the orthopedic implants includes at least one surgical implant opening. (27) a. The one or more orthopedic implants include a first orthopedic implant having a concave inner surface, a convex outer surface located on the opposite side of the concave inner surface, and at least one surgical implant opening extending between the concave inner surface and the convex outer surface, wherein the at least one surgical implant opening extends over the length between the concave inner surface and the convex outer surface, b. An orthopedic implant system of Embodiment 26, wherein the surgical implant opening insert has an axial length greater than the length of the at least one surgical implant opening, so that when the surgical implant opening insert is connected to the first orthopedic implant, the surgical implant opening insert extends beyond the concave inner surface over an axial range or height, the axial range or height defining the minimum cement mantle thickness. (28) Further comprising a second orthopedic implant having a convex outer surface, a. The concave inner surface of the first orthopedic implant defines a cavity sized to receive the second orthopedic implant, and b. The orthopedic implant system according to Embodiment 27, wherein the convex outer surface of the second orthopedic implant is sized to engage with a cement mantle positioned on the concave inner surface of the first orthopedic implant, having the minimum cement mantle thickness. (29) A method for fitting a surgical implant opening to create the smallest possible cement mantle, a) Selecting a surgical implant opening insert for insertion into the surgical implant opening of the first surgical implant, b) Inserting a surgical implant opening insert into the surgical implant opening, c) Applying the cement to the surgical implant so that the cement is at the same height as the distal surface of the insert, d) inserting a further surgical implant into the first surgical implant, wherein the insert is Including a main body portion, the main body portion provides a distal surface and a proximal surface, and the main body portion further provides an intermediate surface extending between the distal surface and the proximal surface, The proximal portion of the intermediate surface includes the surgical implant opening contact portion, A distal portion of the intermediate surface is provided, which is located distal to and extends beyond the surgical implant contact portion, and the distal portion of the intermediate surface provides a cement contact portion. A method wherein the distal surface is a portion facing a further surgical implant. (30) A method for implanting a first surgical implant and a further surgical implant, a) Selecting the first surgical implant, wherein the first surgical implant has at least one surgical implant opening, b) implanting the first surgical implant into the patient's surgical site, c) Selecting a surgical implant opening insert for insertion into the surgical implant opening of the first surgical implant, d) Inserting the surgical implant opening insert into the surgical implant opening of the first surgical implant, e) Applying the cement to the first surgical implant, f) Inserting the additional surgical implant into the first surgical implant in order to implant the additional surgical implant into the patient's surgical site, The aforementioned insert Including a main body portion, the main body portion provides a distal surface and a proximal surface, and the main body portion further provides an intermediate surface extending between the distal surface and the proximal surface, The proximal portion of the intermediate surface includes the surgical implant opening contact portion, A distal portion of the intermediate surface is provided, which is located distal to and extends beyond the surgical implant contact portion, and the distal portion of the intermediate surface provides a cement contact portion. A method wherein the distal surface is a portion facing a further surgical implant.

Claims

1. A surgical implant opening insert, Including a main body portion, the main body portion provides a distal surface and a proximal surface, and the main body portion further provides an intermediate surface extending between the distal surface and the proximal surface, The proximal portion of the intermediate surface includes the surgical implant opening contact portion, A distal portion of the intermediate surface is provided, which is located distal to and extends beyond the surgical implant contact portion, and the distal portion of the intermediate surface provides a cement contact portion. A surgical implant opening insert, wherein the distal surface is a further surgical implant-opposing support portion.

2. The surgical implant opening insert according to claim 1, wherein the proximal portion has an axial range or height h1 which is at least the same as the axial range or height of the surgical implant opening, and the distal portion has an axial range or height h2 which provides space above the distal surface around the surgical implant to set the minimum cement mantle thickness when in use.

3. The surgical implant opening insert according to claim 1 or 2, wherein at least a portion of the insert is formed of a porous material, and the porous material is adapted to facilitate cement interlocking.

4. The surgical implant opening insert according to claim 1, wherein a first portion of the main body is formed of a first material, and a second portion of the main body is formed of a second material, and the first material and the second material differ from each other in their porosity and / or deformability.

5. The surgical implant opening insert according to claim 1, wherein the distal portion is formed of a material having higher porosity than the proximal portion.

6. The surgical implant opening insert according to claim 1, wherein the distal surface is shaped to be complementary to the outer shape of the adjacent section of the surgical implant when in use.

7. The surgical implant opening insert according to claim 1, wherein the distal portion defines the outline of a first cross-section in a plane, and the proximal portion defines the outline of a second cross-section in a plane, and the outline of the first cross-section is larger than the outline of the second cross-section.

8. The surgical implant opening insert according to claim 1, wherein the distal portion is a flange portion, the flange has a distal surface and a proximal surface, the distal surface of the flange is shaped to be complementary to the external shape of an adjacent portion when used with a further surgical implant, and the proximal surface of the flange is shaped to be complementary to the external shape of an adjacent portion when used with the surgical implant.

9. The present invention further includes a through-hole extending between the distal surface and the proximal surface, wherein the through-hole is defined by the through-hole surface. The surface of the through-hole includes the portion that comes into contact with the surgical fixation device. The surgical implant opening insert according to claim 1, wherein the intermediate surface defines the outer shape of a first cross-section within a plane, and the through-hole surface defines the outer shape of a second cross-section within that plane, and the second outer shape is located within the first outer shape.

10. The surgical implant opening insert according to claim 1, wherein at least a portion of the insert is 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, and the shape of the through-hole surface in the first post-deformation state is different from the shape of the through-hole surface in the first pre-deformation state.

11. The surgical implant opening insert according to claim 9, wherein the through-hole surface in the first deformed state is adapted to engage with one or more surfaces of a surgical fixation device.

12. The surgical implant opening insert according to claim 1, wherein the surface of the through-hole includes a portion that contacts a bone engagement surgical fixation device.

13. The surgical implant opening insert according to claim 1, wherein at least a portion of the insert is 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, and the shape of the intermediate surface in the second post-deformation state is different from the shape of the intermediate surface in the second pre-deformation state.

14. The surgical implant opening insert according to claim 13, wherein the intermediate surface in the second deformed state is adapted to engage with one or more surfaces of a surgical implant opening.

15. The surgical implant opening insert according to claim 1, wherein the surface of the through-hole is provided with screw threads.

16. The surgical implant opening insert according to claim 1, wherein the outer shape of the first cross-section in the plane of the intermediate surface is circular, and the outer shape of the second cross-section in the plane of the through-hole surface is also circular and has a diameter smaller than the diameter of the outer shape of the first cross-section.

17. The surgical implant opening insert according to claim 1, wherein the cross-section of the outer shape of the second cross-section decreases along the axis of the through-hole, for example due to the taper of the hole from the distal end to the proximal end.

18. The surgical implant opening insert according to claim 1, wherein the cross-section of the outer shape of the first cross-section is reduced along the axis of the through hole due to a taper of the intermediate surface, for example, over a portion of the transition from the distal end to the proximal end.

19. The surgical implant opening insert according to claim 1, wherein the insert is 3D printed.

20. A surgical kit comprising one or more surgical implant opening inserts as described in claim 1, and one or more surgical implants, wherein at least one of the surgical implants includes at least one surgical implant opening.

21. The surgical kit according to claim 20, wherein the surgical implant is one or more of the following: an acetabular shell, a partial acetabular shell, an acetabular shell liner, and an acetabular cage.

22. The surgical kit according to claim 20 or 21, wherein the kit includes at least two surgical implant opening inserts, each having a distal portion molded to be complementary to the external shape of different portions of adjacent sections of the surgical implant when in use.

23. The surgical kit according to claim 20, comprising a first surgical implant opening insert having a distal portion having an axial range and a second surgical implant opening insert having a distal portion having a second axial range, wherein the first axial range is greater than the second axial range.

24. The surgical kit according to claim 20, wherein the kit further comprises one or more surgical fixation devices.

25. The surgical kit according to claim 20, wherein one or more surgical implants include at least one blind-hole surgical implant opening.

26. An orthopedic implant system comprising one or more surgical implant opening inserts according to claim 1 and one or more orthopedic implants, wherein at least one of the orthopedic implants includes at least one surgical implant opening.

27. a. The one or more orthopedic implants include a first orthopedic implant having a concave inner surface, a convex outer surface located on the opposite side of the concave inner surface, and at least one surgical implant opening extending between the concave inner surface and the convex outer surface, wherein the at least one surgical implant opening extends over the length between the concave inner surface and the convex outer surface, b. The orthopedic implant system of claim 26, wherein the surgical implant opening insert has an axial length greater than the length of the at least one surgical implant opening, so that when the surgical implant opening insert is connected to the first orthopedic implant, the surgical implant opening insert extends beyond the concave inner surface over an axial range or height, the axial range or height defining the minimum cement mantle thickness.

28. Further including a second orthopedic implant having a convex outer surface, a. The concave inner surface of the first orthopedic implant defines a cavity sized to receive the second orthopedic implant, and b. The orthopedic implant system according to claim 27, wherein the convex outer surface of the second orthopedic implant is sized to engage with a cement mantle positioned on the concave inner surface of the first orthopedic implant, having the minimum cement mantle thickness.

29. A method for fitting a surgical implant opening to create the smallest possible cement mantle, a) Selecting a surgical implant opening insert for insertion into the surgical implant opening of the first surgical implant, b) Inserting a surgical implant opening insert into the surgical implant opening, c) Applying the cement to the surgical implant so that the cement is at the same height as the distal surface of the insert, d) inserting a further surgical implant into the first surgical implant, wherein the insert is Including a main body portion, the main body portion provides a distal surface and a proximal surface, and the main body portion further provides an intermediate surface extending between the distal surface and the proximal surface, The proximal portion of the intermediate surface includes the surgical implant opening contact portion, A distal portion of the intermediate surface is provided, which is located distal to and extends beyond the surgical implant contact portion, and the distal portion of the intermediate surface provides a cement contact portion. A method wherein the distal surface is a portion facing a further surgical implant.

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