Temporary antimicrobial adhesive spacers, components, kits, and manufacturing methods

Abstract

This disclosure relates to temporary antimicrobial eluting adhesive spacer implants (1) and components, kits, and methods for forming said spacer implants. Particularly preferred disclosures relate to modular spacers, components, and kits, and methods of manufacturing them, wherein the modular nature of said spacers allows for selection of spacers of specific desired lengths and specific selection of antimicrobial compounds and dosages, as well as the parts and processes for forming them.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 074,516, filed on September 4, 2020, in the name of Navarro Vale et al., the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure relates to temporary antimicrobial eluting adhesive spacer implants, components, kits, and methods of forming them. Particularly preferred disclosures are modular spacer implants, components, and kits, and methods of manufacturing them, wherein the modular nature of the spacer allows for selection of spacers of specific desired lengths and specific selection of antimicrobial agent compounds and dosages, as well as the components and processes used to form them. Background Technology

[0004] Currently in the United States, there are no regulatory-approved products suitable as temporary intramedullary antimicrobial eluting spacers for treating localized infections of the intramedullary canal in long bones such as the tibia, while simultaneously filling cavities created by infected nails. For many years, surgeons have resorted to using available off-label products to create such implants with limited stability compared to intramedullary locking nails and limited control over the local release rate of antimicrobial drugs.

[0005] Current treatment options consist of a poly(methyl methacrylate) (PMMA) adhesive mixed with an antimicrobial agent to produce a bone adhesive with drug-eluting properties. This bone adhesive is then shaped using a chest tube or hand-rolled with an insertable metal core to achieve rigidity and anchoring. Surgically fabricated handmade tibial spacer nails present numerous challenges, including: the time and complexity required for implant fabrication during surgery; the possibility of adhesive breakage; a lack of mechanisms to capture broken adhesive during removal; unevenness of implants between patients; the complexity of implant fabrication; and the occasional need for re-fabrication due to insufficient or irregular adhesive coverage.

[0006] Therefore, there is a need for standardized care that will provide surgeons with the reliable ability to fabricate intramedullary spacers loaded with antimicrobial agents during surgery and to reliably remove these spacers once the infection treatment regimen has ended. Summary of the Invention

[0007] Therefore, this disclosure relates to the treatment of surgical site infections (SSIs) involving infected implantable medical devices. More specifically, this disclosure relates to temporary antimicrobial wash-off adhesive spacer implants and components, kits, and methods for forming said spacer implants. Particularly preferred disclosures are modular spacers, components, and kits, and methods of manufacturing them, wherein the modular nature of the spacer allows for selection of spacers of specific desired lengths and specific selection of antimicrobial compounds and dosages, as well as the components and processes for forming them. A particular benefit is the ability of surgeons or other qualified healthcare professionals to design spacers specific to the patient's condition present at the time of surgery during the perioperative period.

[0008] These temporary spacer implants are typically used in cases of infected orthopedic implants requiring revision surgery; for example, for intramedullary nails in the femur or tibia.

[0009] According to this disclosure, an antimicrobial elution temporary adhesive spacer is disclosed, the temporary adhesive spacer comprising:

[0010] Spacer core, the spacer core comprising

[0011] A rod, the rod defining a central axis of the spacer core and having a proximal rod end and a distal rod end opposite the proximal rod end along the central axis, the rod further defining an outer rod surface extending between the proximal rod end and the distal rod end;

[0012] A locking member defining a distal locking end and a proximal locking end opposite the distal locking end along the central axis, the distal locking end being attached to the rod at the proximal rod end; the locking member further defining at least one locking hole extending radially through the locking member relative to the central axis, the at least one locking hole being configured to receive a locking screw; and

[0013] A cap-shaped member defining a proximal cap-shaped end and a distal cap-shaped end opposite the proximal cap-shaped end along the central axis, the proximal cap-shaped end being attached to the distal rod end; and

[0014] An adhesive coating that surrounds at least a portion of the surface of the outer rod, the adhesive coating comprising a mixture of an adhesive material and one or more antimicrobial agents;

[0015] The cap-shaped member is configured to define the front end of the temporary spacer during implantation.

[0016] According to a particular embodiment, the outer rod surface includes a threaded surface at the proximal rod end, and wherein the distal locking end defines a distal locking opening configured to thread-engage with the proximal rod end. In another embodiment, the outer rod surface includes a threaded surface at the distal rod end, and wherein the proximal cap-like end defines a proximal cap-like opening configured to thread-engage with the distal rod end. In still other embodiments, the outer surface of the rod includes a continuous threaded surface extending from the distal rod end to the proximal rod end.

[0017] According to a particular implementation, the at least one locking hole includes a plurality of locking holes.

[0018] According to a particular embodiment, the locking member extends axially from the distal locking end to the proximal locking end, such that the proximal locking end can be offset radially relative to the central axis at an angle θ. In a particular embodiment, the angle of offset is in the range of about 5 degrees to about 20 degrees.

[0019] In a particular embodiment, the cap-shaped member is defined in a cross-sectional area in a plane perpendicular to the central axis, and wherein the cross-sectional area of ​​the cap-shaped member defines the maximum cross-sectional area of ​​the temporary spacer.

[0020] According to a particular embodiment, the temporary spacer includes one or more centering members extending radially outward from the surface of the outer rod. In other embodiments, each of the one or more centering members defines four arms, each arm extending radially outward from the surface of the outer rod.

[0021] According to another embodiment, the locking member defines an outer locking surface extending from the proximal locking end to the distal locking end. In other embodiments, the outer locking surface may define at least one planar portion extending in a direction from the proximal locking end to the distal locking end. In other embodiments, the at least one planar portion comprises a plurality of planar portions, each of the plurality of planar portions being equidistant from another planar portion along the outer locking surface.

[0022] According to another embodiment, the outer locking surface further defines at least one surface channel extending in a direction from the proximal locking end to the distal locking end. In a particular further embodiment, the at least one surface channel is directly adjacent to at least one of the at least one planar portions. According to a particular embodiment, the at least one surface channel includes a plurality of surface channels, such that each of the plurality of surface channels is directly adjacent to the at least one planar portion.

[0023] According to a particular embodiment, the cap-shaped member defines a plurality of windows extending through the cap-shaped member from the distal end to the proximal end in a direction substantially coaxial with the central axis. In a particular embodiment, the plurality of windows are evenly distributed around the cap-shaped member.

[0024] According to a specific implementation, the curable polymer material includes poly(methyl methacrylate) (PMMA) or copolymers thereof.

[0025] According to a specific embodiment, the antimicrobial agent includes antibiotics, antifungal agents, or combinations thereof. For example, suitable antibiotic classes may include aminoglycoside antibiotics and glycopeptide antibiotics. Specific agents may include, for example, gentamicin, tobramycin, vancomycin, amikacin, rifampin, clindamycin, erythromycin, colistin, linezolid, daptomycin, fosfomycin, and amphotericin B, or combinations thereof. Preferred agents may include gentamicin, tobramycin, and vancomycin, or combinations thereof.

[0026] According to a particular embodiment, the rod comprises a metal or metal alloy, or a thermoplastic polymer material. According to other embodiments, the locking member comprises a metal or metal alloy, or a thermoplastic polymer material. In other embodiments, the cap-like member comprises a metal or metal alloy, or a thermoplastic polymer material.

[0027] According to this disclosure, a mold assembly for forming the temporary adhesive spacer is disclosed, the mold assembly comprising:

[0028] Spacer core, the spacer core comprising

[0029] A rod, the rod defining a central axis of the mold assembly and having a proximal rod end and a distal rod end opposite the proximal rod end along the central axis, the rod further defining an outer rod surface extending between the proximal rod end and the distal rod end;

[0030] A locking member defining a distal locking end and a proximal locking end opposite the distal locking end along the central axis, the distal locking end being attached to the rod at the proximal rod end; the locking member further defining at least one locking hole extending radially through the locking member relative to the central axis, the at least one locking hole being configured to receive a locking screw; and

[0031] A mold body extending along a central axis defines a proximal mold end and a distal mold end opposite to the proximal mold end along the central axis, the proximal mold end including a proximal mold opening and the distal mold end including a proximal mold opening, wherein the mold body defines an inner mold surface extending between the proximal mold opening and the distal mold opening, wherein the inner surface defines a mold cavity, wherein the spacer core is disposed within the mold cavity such that the locking member is disposed within the mold cavity at the proximal mold end;

[0032] At least one plug, the at least one plug being disposed in the at least one locking hole; and

[0033] An adapter configured to be operatively coupled to the mold body at the distal mold end, the adapter being configured to operatively couple the mold body to a bone cement injection device to provide a fluid pathway from the cement injection device through the distal mold opening to the mold cavity.

[0034] According to a particular embodiment, the at least one locking hole includes a plurality of locking holes. In a particular embodiment, the at least one hole plug includes a plurality of hole plugs. In a particular further embodiment, each of the plurality of locking holes has a hole plug disposed therein among the plurality of hole plugs, such that the number of the plurality of locking holes is equal to the number of the plurality of hole plugs. In an alternative embodiment, a first portion of the plurality of locking holes has the plurality of hole plugs disposed therein, and a second portion of the plurality of locking holes does not have the plurality of hole plugs disposed therein.

[0035] According to a particular embodiment, the mold body further includes at least one mold hole extending radially through the mold body and the mold cavity relative to the central axis, and wherein the at least one plug is configured to be disposed in the at least one mold hole. In a particular embodiment, the at least one mold hole is aligned with the at least one locking hole such that the at least one plug can be disposed within both the at least one locking hole and the at least one mold hole. In a particular embodiment, the at least one mold hole includes a plurality of mold holes.

[0036] According to a particular embodiment, the mold body includes a separation device extending axially from the proximal mold end to the distal mold end along the mold body. In a particular embodiment, the mold body further defines an outer mold surface extending between the proximal mold end and the distal mold end, and wherein the separation device includes a plurality of perforations, a groove in the outer mold surface, or a strip of material or a combination thereof disposed within the mold body. In a particular embodiment, the mold body also includes one or more reinforcing members. In other embodiments, the mold assembly further includes one or more tabs disposed at the proximal mold end or the distal mold end of the mold body.

[0037] According to a particular embodiment, the spacer core also includes a cap-shaped element configured to be operatively coupled to the distal end of the rod.

[0038] According to a particular embodiment, the adapter defines a proximal end operably coupled to the distal end of the mold body and defining a proximal opening. Additionally, the adapter further defines an opposing distal end configured operably coupled to the bone cement injection device and having a distal opening, such that the adapter includes an adapter recess extending between the distal and proximal openings, the adapter recess providing the continuous fluid passage. In a particular further embodiment, the adapter includes an inner wall defining an adapter reservoir with a reservoir opening, and wherein the distal end of the rod is disposed within the adapter reservoir.

[0039] According to a particular embodiment, the mold assembly further includes a cap-like member configured to be operatively coupled to the distal end of the spacer core. In a particular embodiment, the cap-like member defines a plurality of windows extending axially through the cap-like member from the distal end to the proximal end.

[0040] According to this disclosure, a kit for forming temporary adhesive spacers is disclosed, the kit comprising:

[0041] At least one rod, the at least one rod defining a proximal rod end and a distal rod end opposite to the proximal rod end;

[0042] A locking member configured to be operably coupled to the rod, the locking member defining a distal locking end and a proximal locking end opposite the distal locking end, the distal locking end being configured to be attached to the rod at the proximal rod end, the locking member further defining at least one locking hole extending through the locking member and configured to receive a locking screw, wherein the at least one rod and the locking member are configured to form a spacer core when operably coupled;

[0043] At least one hole plug, the at least one hole plug being configured to be removably disposed within the at least one locking hole;

[0044] A mold body defining a proximal mold end and a distal mold end opposite to the proximal mold end, and an outer mold surface extending from the proximal mold end and the distal mold end, the mold body further defining a proximal mold opening at the proximal mold end and a distal mold opening at the distal mold end, and an inner mold surface extending between the proximal mold opening and the distal mold opening, the inner mold surface defining a mold cavity extending therebetween, wherein the spacer core is configured to be disposed in the mold cavity;

[0045] An adapter configured to operably connect to the mold body at the distal mold end, wherein the adapter is further configured to connect a bone cement injection device to the distal mold opening to provide a fluid pathway from the cement injection device to the mold cavity; and

[0046] A cap-shaped member, which is configured to be operatively attached to the distal end of the rod.

[0047] According to certain other embodiments, the at least one rod includes a plurality of rods, each of which has a length measured between the proximal rod end and the distal rod end, and wherein each rod length is different from any other rod length among the plurality of rods. In a particular embodiment, the at least one rod defines an outer rod surface extending from the proximal rod end to the distal rod end, and further, wherein the outer rod surface includes a continuous threaded surface.

[0048] According to a particular embodiment, the at least one hole plug includes a plurality of hole plugs.

[0049] According to a particular embodiment, the kit also includes at least one locking bone screw, wherein the at least one locking screw is configured to be disposed in the at least one locking hole and is further configured to secure the temporary spacer to the bone.

[0050] According to a particular embodiment, the kit includes an insertion device configured to be operatively coupled to the proximal end of the locking member, wherein the insertion device is configured to implant the temporary spacer.

[0051] According to this disclosure, a method for forming an antimicrobial elution temporary adhesive spacer is described, the method comprising the following steps:

[0052] A spacer core is inserted into the inner cavity of the mold body. The spacer core includes a rod and a locking component connected to the rod, wherein the locking component includes at least one locking hole.

[0053] An adapter is used to connect the bone cement injection device to the mold body to provide a fluid passage from the bone cement injection device to the cavity of the mold body;

[0054] At least one plug is placed into the at least one locking hole;

[0055] Bone cementing material comprising one or more antimicrobial agents is injected into the cavity of the mold body through the fluid passage and along at least a portion of the outer surface of the rod;

[0056] The bone adhesive material is cured on the surface of the outer rod to form an adhesive coating on the spacer core, thereby forming the antimicrobial elution temporary adhesive spacer;

[0057] Disconnect the bone cement injection device from the mold body;

[0058] Remove the at least one hole plug from the at least one locking hole; and

[0059] Separate the mold body from the antimicrobial elution temporary adhesive spacer.

[0060] According to a particular embodiment, the method further includes connecting the rod to the locking member prior to the step of inserting the spacer core into the mold cavity. In a particular embodiment, the method further includes operably coupling the proximal end of the rod to the distal end of the locking member.

[0061] According to a particular embodiment, the rod has a rod length measured from the proximal rod end to the opposite distal rod end, and the method further includes removing a portion of the rod length from the proximal rod end or the distal rod end prior to the step of inserting the spacer core.

[0062] According to another embodiment, the mold body defines a mold length measured from a proximal mold end to an opposite distal mold end, and the method includes removing a portion of the mold body length from either the proximal mold end or the distal mold end.

[0063] According to a particular embodiment, the mold body defines an outer mold surface extending from the proximal mold end to the distal mold end, and the mold body includes at least one mold hole extending from the outer mold surface through the mold cavity, the method including aligning the at least one locking hole with the at least one mold hole. According to other embodiments, the step of disposing the at least one hole plug in the at least one locking hole further includes disposing the at least one hole plug in the at least one mold hole.

[0064] According to a particular embodiment, the method may further include attaching a cap-like element to the rod. In another embodiment, the step of attaching the cap-like element occurs after the step of disengaging the mold body from the bone cement injection device.

[0065] In certain other embodiments, the cap-like member defines a proximal cap-like member end and an opposing distal cap-like member end, the proximal cap-like member end being operatively coupled to the distal end of the rod, the cap-like member including a plurality of windows extending through the cap-like member from the distal cap-like member end to the proximal cap-like member end, and the plurality of windows being configured to provide fluid passage from the adhesive injection device to the mold cavity, the method further comprising injecting bone adhesive material into the mold cavity through the cap-like member windows. Attached Figure Description

[0066] Figure 1A This is a side view photograph of a temporary adhesive spacer according to an embodiment of this disclosure;

[0067] Figure 1B It is a side view of a spacer core including a rod, a locking component, and a cap-shaped component according to a specific embodiment;

[0068] Figure 1C It is based on Figure 1B An exploded view of the spacer core shows the threaded outer surfaces at the proximal and distal ends of the rod;

[0069] Figure 1D This is an exploded view of an alternative implementation scheme, showing the fully threaded outer surface of the rod;

[0070] Figure 2A yes Figure 1C A cross-sectional side view of the locking component shown;

[0071] Figure 2BIt is viewed from the proximal end. Figure 1C The cross-section of the locking component shown;

[0072] Figure 2C This is a perspective view of an alternative locking component, showing multiple offset radial holes;

[0073] Figure 3 yes Figure 1B A cross-sectional side view of the cap-shaped component shown;

[0074] Figure 4A yes Figure 3 A side view of an alternative embodiment of the cap-shaped member, showing multiple axial window openings;

[0075] Figure 4B This is a cross-sectional side view of the cap-shaped component of 4A;

[0076] Figure 5A This is a perspective view of a mold assembly according to an embodiment of this disclosure;

[0077] Figure 5B yes Figure 5A An exploded view of the mold assembly shown;

[0078] Figure 6 It is a cross-sectional side view of the mold body according to a specific embodiment, showing a plurality of perforations extending axially along the mold body;

[0079] Figure 7 This is a perspective view of an alternative embodiment of the mold body according to a particular embodiment, showing two material strips embedded in the mold body and extending axially;

[0080] Figure 8A This is a perspective view of another alternative embodiment of the mold body, showing a pair of axially extending grooves along the outer surface of the mold body;

[0081] Figure 8B yes Figure 8A A cross-sectional view of the mold body shown;

[0082] Figure 8C -D is Figure 8A -B shows a cross-sectional view of an alternative mold body, illustrating reinforcement of the mold body;

[0083] Figure 9A It uses an adapter to connect to the bone cement injection device. Figure 5A A cross-sectional side view of the mold assembly;

[0084] Figure 9B yes Figure 9A An enlarged view of the area within circle A;

[0085] Figure 9C yes Figure 9A A perspective view of the distal end of the adapter;

[0086] Figure 9D yes Figure 9A A perspective view of the proximal end of the adapter;

[0087] Figure 10A It is a cross-sectional side view of an alternative embodiment of the adapter, bone cement injection device and mold body according to a specific embodiment;

[0088] Figure 10B yes Figure 10A A perspective view of the distal end of the adapter shown;

[0089] Figure 11 yes Figure 5A An exploded perspective view of the proximal end of the mold body assembly, showing the insertion handle.

[0090] Figure 12 This is an exploded perspective view of a mold assembly according to another embodiment of this disclosure;

[0091] Figure 13A is Figure 12 A perspective view of the locking component of the mold assembly shown;

[0092] Figure 13B is a cross-sectional end view of the locking component taken along section lines 13B-12B in Figure 13A;

[0093] Figure 13C This is a perspective view of the proximal end of the locking component shown in Figure 13A;

[0094] Figure 13D This is a cross-sectional perspective view of the proximal end of the locking member shown in FIG13A according to another embodiment of the present disclosure, the proximal end having an end plug therewith;

[0095] Figure 14A is Figure 12 A perspective view of the cap-shaped part of the mold assembly shown;

[0096] Figure 14B is another perspective view of the cap-shaped member shown in Figure 14A, showing the adhesive channel defined by the cap-shaped member;

[0097] Figure 14C is a cross-sectional end view of the cap-shaped piece taken along section line 14C-14C in Figure 14A;

[0098] Figure 15A yes Figure 12 A side view of the mold body of the mold assembly shown;

[0099] Figure 15B yes Figure 15A A cross-sectional side view of a portion of the mold body within circle 15B;

[0100] Figure 16A shows the cutting method. Figure 15A A perspective view of the cutting tool for the mold body shown;

[0101] Figure 16B is another perspective view of the cutting tool shown in Figure 16A, showing the cutting tool oriented to perform a transverse cut on the mold body;

[0102] Figure 16C is another perspective view of the cutting tool shown in Figure 16A, showing the cutting tool oriented to perform a longitudinal cut along the length of the mold body;

[0103] Figure 17 It is used for cutting Figure 15A A perspective view of another embodiment of the cutting tool for the mold body shown;

[0104] Figure 18A yes Figure 12 A perspective view of the adapter of the mold assembly shown;

[0105] Figure 18B yes Figure 18A The adapter shown is a cross-sectional side view;

[0106] Figure 18C It is connected to Figure 15A The mold body shown Figure 18A Cross-sectional perspective view of the adapter shown;

[0107] Figure 19A Is with Figure 18A A perspective view of the handle component used with the adapter shown;

[0108] Figure 19B It is connected to Figure 18C The adapter shown Figure 19A A perspective view of the handle component shown;

[0109] Figure 20A shows the method for removing [the item]. Figure 12 A perspective view of the forming tool with excess adhesive in the mold assembly shown;

[0110] Figure 20B is a cross-sectional side view of the forming tool shown in Figure 20A;

[0111] Figure 20C This is a partial cross-sectional side view of the forming tool in Figure 20A, showing its engagement with the cap-shaped piece shown in Figure 14A;

[0112] Figure 21 It includes Figure 12A plan view of the mold assembly kit shown; and

[0113] Figure 22 It is by Figures 12 to 21 A perspective view of the temporary spacers constructed from the mold assembly and related components shown. Detailed Implementation

[0114] This disclosure relates to temporary antimicrobial eluting adhesive spacer implants and components, kits, and methods for forming said spacer implants for treating surgical site infections (SSIs). Typically, these temporary spacer implants are formed from an antimicrobial agent mixed into a polymeric or ceramic adhesive material and are used in cases of infected orthopedic implants requiring revision surgery; for example, for intramedullary nails in the femur or tibia. The temporary spacer typically approximates the shape of the removed infected implant. Once the infected implant has been removed, the temporary antimicrobial eluting spacer implant is inserted into the same location, and the adhesive material comprising the antimicrobial agent provides a local drug reservoir that elutes the antimicrobial agent to reduce infection and prevent bacterial growth on the spacer at the implant site. Once the infection has been resolved, the temporary spacer is removed, and a new, permanent revision implant is then placed in the location.

[0115] This disclosure specifically relates to modular temporary spacers, wherein the modular nature of the spacer allows for both selection of spacers of a specific desired length and specific selection of the antimicrobial compound and dosage to be mixed into the adhesive material. Additionally, the temporary adhesive spacer can be used in conjunction with locking screws to secure the spacer to adjacent bone, providing the benefit of maintaining the position and stability of the temporary spacer in the desired location. Essentially, the temporary spacers of this disclosure can be customized to the specific criteria of an individual patient and can be properly secured once implanted. An additional benefit is the ability of surgeons or other qualified healthcare professionals to design temporary spacers according to this disclosure during the perioperative period and to form them during or near surgery. Therefore, surgeons can assess the situation when removing infected implants and simultaneously prepare temporary spacer implants to most appropriately address the surgical site condition.

[0116] As will be described in more detail below, this disclosure includes components and kits comprising a mold body and a spacer core for forming a temporary spacer. The mold body has an inner cavity configured to accommodate the spacer core and receive injected antimicrobial adhesive material that cures and hardens to form an adhesive coating around the spacer core, and thus the mold body is configured to substantially define the shape of the temporary spacer. This disclosure further describes a method of forming a temporary spacer using the mold body, spacer core, and antimicrobial adhesive material.

[0117] Terms and phrases indicating anatomical reference, such as “proximal” and “distal,” may be used throughout this disclosure with reference to the implants, components, kits, and methods described herein, as well as the natural anatomy of the patient. Such terms have well-known meanings in the fields of anatomical studies and orthopedic surgery. Unless otherwise specified, such terms as used in the specification and claims are intended to conform to their well-known meanings.

[0118] Based on this disclosure and with reference to Figures 1A to 1D Disclosed is an antimicrobial elution temporary spacer 1, comprising a spacer core 5 and an antimicrobial adhesive coating 85 surrounding at least a portion of the spacer core 5. The adhesive coating 85 comprises an adhesive material and is configured for treating infection; the adhesive material comprises a curable polymeric material or a curable ceramic material that can be mixed with one or more antimicrobial agents. The temporary spacer core 5 is configured to provide a structural frame for the temporary spacer 1 and includes a rod 20, a locking member 40, and a cap 60. The locking member 40 and the cap 60 are configured to engage opposite ends (i.e., proximal and distal ends) of the rod 20, as will be explained in more detail below.

[0119] According to a specific implementation, the curable polymer material includes poly(methyl methacrylate) (PMMA) or copolymers thereof.

[0120] According to a specific implementation, antimicrobial agents include antibiotics, antifungal agents, or combinations thereof. For example, suitable antibiotic classes may include aminoglycoside antibiotics and glycopeptide antibiotics. Specific agents may include, for example, gentamicin, tobramycin, vancomycin, amikacin, rifampin, clindamycin, erythromycin, colistin, linezolid, daptomycin, fosfomycin, and amphotericin B, or combinations thereof. Preferred agents may include gentamicin, tobramycin, and vancomycin, or combinations thereof.

[0121] According to a particular embodiment, the rod 20 comprises a metal or metal alloy, or a thermoplastic polymer material. According to other embodiments, the locking member 40 comprises a metal or metal alloy, or a thermoplastic polymer material. In other embodiments, the cap 60 comprises a metal or metal alloy, or a thermoplastic polymer material. Suitable metals may include, for example, standard orthopedic implant-grade metals or alloys, such as 316L stainless steel, titanium, Ti-6Al-4V alloy, Ti-6Al-7Nb alloy, or cobalt-chromium alloy. Suitable thermoplastics may include, for example, any polymer or copolymer of the polyaryletherketone family, such as polyetheretherketone (PEEK), as well as polyethylene, polypropylene, or nylon.

[0122] refer to Figure 1A-D, rod 20 is elongated in the longitudinal direction L and defines the central axis C of both the spacer core 5 and the temporary spacer 1 extending in the longitudinal direction. As used herein, terms such as “axial” or “axially” or their derivatives are intended to define the directional component that extends substantially or completely together with the central axis C.

[0123] The rod 20 further defines a proximal rod end 22 and a distal rod end 24 opposite to the proximal rod end 22 along the central axis C, as well as an outer rod surface 26 extending from the proximal rod end 22 to the distal rod end 24.

[0124] The lever 20 is configured to be attached to the locking member 40 at the proximal end 22. The lever 20 is also configured to be attached to the cap 60 at the distal end 24. Therefore, refer to... Figure 1C A portion of the outer rod surface 26 at the proximal end 22 may be configured as a threaded surface 28, allowing it to thread-engage with the locking member 40. Additionally, a portion of the outer rod surface 26 at the distal end 24 may be configured as a threaded surface 28, allowing it to thread-engage with the cap member 60. Alternatively, and referring to… Figure 1D Essentially, the entire outer rod surface 26 can be configured as a threaded surface 28. As used herein with respect to the threaded surface 28, "essentially" means at least 50% to up to 100% (such as 50%, 60%, 70%, 80%, 90%, or 100%, or any suitable subrange derived from the percentages listed herein) of the outer rod surface 26 is a threaded surface 28. For example, as... Figure 1D As shown, 100% of the outer rod surface 26 is configured as a threaded surface 28, such that the outer rod surface 26 can be described as a continuous threaded surface 28 extending from the distal rod end 24 to the proximal rod end 22. This particular example of the continuous threaded rod 20 provides the benefits of the modular nature of the temporary spacer 1 previously described. Using the continuous threaded rod 20, the surgeon can cut the rod 20 to any desired length while still maintaining the threaded surface 28 at both the proximal rod end 22 and the distal rod end 24 for threaded engagement with both the locking member 40 and the cap 60, respectively.

[0125] refer to Figures 1B to 2CThe spacer core 5 includes a locking member 40 configured to attach to the rod 20 at the proximal rod end 22. The locking member 40 is configured to provide a structure for locking screws to secure the temporary spacer 1 to adjacent bone, as will be explained in more detail below. The locking member 40 is generally elongated in the axial direction (i.e., elongated along the central axis C in the same direction as the rod 20). The locking member 40 includes a distal locking end 44 configured to attach to the proximal rod end 22 and a proximal locking end 42 opposite to the distal locking end 44 along the central axis C. An outer locking surface 46 extends from the proximal locking end 22 to the distal locking end 46.

[0126] The distal locking end 46 is configured to be operably coupled to the proximal rod end 22 and may include a distal locking opening 32 and an inner distal locking surface 33 defining a distal locking recess 35 extending proximally from the distal locking opening 32 toward the proximal locking end 42. The distal locking recess 35 is configured to receive the proximal rod end 22 such that when the rod 20 is operably coupled to the locking member 40, the proximal rod end 22 is at least partially disposed in the distal locking recess 35. In a particular example, such as Figure 2A As shown, the inner distal locking surface 33 may be threaded and configured to be threadedly connected to the corresponding threaded surface 28 of the proximal rod end 22 (as previously described).

[0127] refer to Figure 1C , Figure 2A and Figure 2C The locking component 40 includes at least one locking hole 55 configured to receive a locking screw for securing the temporary spacer 1 to adjacent bone. Locking screws are well known in the field of orthopedic implants and are used to pass through openings in implants and secure to bone adjacent to the implant. One advantage of using the locking component 40, which includes at least one locking hole, is the ability to provide a degree of stability once implanted in a patient by using the locking screw. While the use of locking screws is not intended to provide the same load-bearing stability as they do in standard orthopedic implants, the ability to partially stabilize the temporary spacer 1 minimizes the possibility that the spacer may be damaged or otherwise migrate from its intended location during implantation in a patient.

[0128] Continue to refer to Figure 1C , Figure 2A and Figure 2CThe at least one locking hole 55 of the locking member 20 extends through the locking member 40 in the radial direction R relative to the central axis C. As used herein, terms such as “radial” or “radially” or their derivatives are directions or locations defined relative to the central axis C and may include both radially inward directions toward the central axis C and radially outward directions away from the central axis C. In a particular example, the radial direction is oriented perpendicular to the central axis C, and in other examples, the radial direction may be angularly offset from the direction perpendicular to the central axis C but not coaxial with or parallel to the central axis C. Preferably, the radial extension of the at least one locking hole 55 is perpendicular to the central axis C.

[0129] refer to Figures 1C to 1D as well as Figure 2A and Figure 2C The at least one locking hole 55 may include multiple locking holes 55, such as two, three, four, or up to six locking holes 55. The advantage of multiple locking holes 55 is that they provide the surgeon with multiple methods for securing the temporary spacer 1 to adjacent bone using locking screws or multiple locking screws as needed. It should be understood that the anatomical area receiving the temporary spacer 1 has suffered from invasive infection and symptoms associated with the removal of the infected primary implant. Therefore, tissue damage may exist, particularly in damaged bone tissue in the area where the surgeon will typically attempt to secure the temporary spacer 1 using locking screws. Therefore, providing multiple options for positioning healthy bone tissue for fixation is beneficial for the surgeon to successfully implant the temporary spacer 1.

[0130] The locking component 40 may be further configured to engage with one or more insertion devices that assist a surgeon or other medical professional in placing the temporary spacer 1 into the patient's desired anatomical position. In one example, such as... Figure 2A As shown, the proximal locking end 42 includes a proximal locking opening 50 and a proximal locking inner surface 51, the proximal locking inner surface defining a proximal locking recess 53 extending distally from the proximal locking opening 50 toward the distal locking end 44. In a particular example, such as Figure 11 As shown and explained in further detail below, the proximal locking end 42 is configured to receive the insertion device 300 within the proximal locking recess 53. In a particular example, the proximal locking inner surface 51 may be threaded and configured to connect with a corresponding threaded part or surface thread of the insertion device 300.

[0131] In a specific example, such as Figure 1BAs shown, the locking member 40 may extend axially from the distal locking end 44 to the proximal locking end 42, such that the proximal locking end 42 may be radially offset by an angle θ from the distal locking end 44 relative to the direction of the central axis C. The purpose of this angular offset is to better align the shape of the temporary spacer 1 with the natural anatomy of the patient's bone, where appropriate, both in terms of the insertion of the temporary spacer 1 and in maintaining proper anatomical alignment after implantation. In a particular embodiment, the angular offset θ may be any value within the range of about 5 degrees to about 20 degrees (e.g., from about 5 degrees to about 15 degrees, or from about 8 degrees to 12 degrees, or within any sub-combination of the endpoints of the ranges listed herein).

[0132] refer to Figures 1B to 1D as well as Figures 3 to 4B The cap-shaped member 60 defines a proximal end 62, which is configured to attach to the rod 20 at the distal end 24 of the rod. The cap-shaped member 60 further defines a cross-sectional area measured in a plane perpendicular to the central axis C, and the cross-sectional area of ​​the cap-shaped member 60 defines the maximum cross-sectional area of ​​the temporary spacer 1. In other words, the cap-shaped member 60 is designed preferably to be the widest portion of the temporary spacer 1, but in other embodiments, a locking member may define the maximum cross-sectional area of ​​the temporary spacer 1. Defining the maximum cross-sectional area by the cap-shaped member 60 provides two benefits. First, during implantation, the cap-shaped member 60 is configured as the front end of the temporary spacer 1 and is therefore frequently subjected to significant mechanical forces, such as compressive and shear forces. Therefore, the cap-shaped member 60 provides forward support to absorb those forces and clear the passage as the temporary spacer 1 penetrates into the desired anatomical location. This protects portions of the adhesive coating 85 from cracking or otherwise detaching from the temporary spacer 1 and impairing its function in vivo. Second, as previously stated, the temporary spacer 1 of this disclosure needs to be removed once the clinically prohibited period of antimicrobial treatment has expired. The function of the cap 60 during removal is to collect any debris of the adhesive coating 85 generated. In other words, the cap 60 is preferably designed such that, when the temporary spacer 1 is removed from the patient, the cap 60 is used to push upwards (or collect) any broken adhesive fragments from the adhesive coating 85 that have detached or broken during or before the removal of the temporary spacer 1.

[0133] Continue to refer to Figure 3 as well as Figures 4A to 4BThe cap-shaped member 60 includes a distal cap-shaped member end 64 opposite to the proximal cap-shaped member end 62 along a central axis C. An outer cap-shaped member surface 66 extends from the proximal cap-shaped member end 62 to the distal cap-shaped member end 64. The proximal cap-shaped member end 62 includes a cap-shaped member opening 70 and an inner cap-shaped member surface 71 defining a cap-shaped member recess 73 that extends in the distal direction D from the cap-shaped member opening 70 toward the distal cap-shaped member end 64 into the cap-shaped member 60, such that the cap-shaped member recess 73 can be said to extend distally from the cap-shaped member opening 70. The cap-shaped member recess 73 is configured to receive a distal rod end 24 such that, when coupled, the distal rod end 24 is at least partially disposed within the cap-shaped member recess 73. In a particular example, such as Figure 3 and Figure 4B As shown, the inner cap-shaped surface 71 may be threaded and configured to be threadedly connected to the corresponding threaded surface 28 of the distal rod end 24.

[0134] refer to Figures 1B to 1C In a particular example, the spacer core 5 of the temporary spacer 1 may include one or more centering members 31 extending radially outward from the outer rod surface 26. As will be explained in more detail below, a mold assembly 100 is disclosed, wherein the spacer core 5 is configured to be inserted into the mold body 120 to form, for example, the temporary spacer 1, such as... Figure 5A As shown in the diagram. Therefore, in a particular example, there is an element of the spacer core 5 that interacts with the mold body 120 during the formation of the temporary spacer 1. In a particular embodiment, the centering member 31 may be attached to the rod 20, and in another embodiment, the rod 20 and the centering member 31 may be formed as a single monolithic structure. The centering member 31 serves to provide offset between the rod 20 and the mold body 120, and to keep the rod aligned along the central axis C when it is positioned within the mold body 120 (e.g., as shown in the diagram). Figure 5A (As shown in the diagram). This alignment of the rod 20 longitudinally along the central axis C helps to form a uniform distribution of adhesive material for forming the adhesive coating 85 around the spacer core 5, because the rod 20 will be centered within the mold body 120.

[0135] Centering member 31 may include at least a single arm extending radially outward from rod 20. For example, each centering member 31 may include multiple arms. The arms of centering member 31 may be circumferentially spaced apart from each other around an outer surface. For example, as Figures 1B to 1C (as well as Figures 5A to 5BAs shown in the diagram, two centering members 31 are attached to the rod 20 and have a generally cross-shaped (or X-shaped) cross section, wherein four (4) arms extend radially outward from the rod 20. This cross-shaped design provides space between the arms of the centering members to allow adhesive material to flow through the centering members 31 and coat the outer rod surface 26 during the process of forming the adhesive coating 85. It should also be understood that the centering members 31 may adopt any suitable cross-sectional geometry, provided that they do not obstruct or otherwise inhibit the flow of fluid adhesive material.

[0136] As previously described, the temporary spacer 1 of this disclosure is designed to have a modular function that allows the surgeon to use a rod 20 of a desired length based on the specific condition of the patient's anatomy. Therefore, it should be understood that more or fewer centering members 31 may extend from the rod 20 depending on the desired length selected for it. For example, 1, 2, 3, 4, 5, or up to 8 centering members 31 may extend outward from the rod 20.

[0137] refer to Figure 1B -C and Figure 2A -C, the outer locking surface 46 may define at least one planar portion 48 extending in a direction from the proximal locking end 42 to the distal locking end 44. This is an additional element of the spacer core 5, which is configured to work together with the mold body 120 to form a temporary spacer 1. A potential benefit of the planar portion 48 is that, when the spacer core 5 is disposed within the mold body 120, it creates a gap or void between the mold body 120 and the locking member 40. This gap or void provides space for entry along a portion of the outer locking surface 46 when adhesive material is injected into the mold body 120 to form an adhesive coating 85. In a particular example, such as Figure 2B As shown, the outer locking surface 46 may include a plurality of planar surfaces 48, such as two planar portions 48. In a preferred embodiment, the planar portions 48 are disposed equidistantly from each other on the locking outer surface 46.

[0138] In certain other implementations, and continuing to refer to Figure 2A-C, the outer locking surface 46 may define at least one surface channel 47 extending in a direction from the proximal locking end 42 to the distal locking end 44. The advantage of including a surface channel 47 along the outer surface 46 is that when the fluid adhesive material forming the adhesive coating 85 flows into the mold body 120, it can fill and harden the at least one surface channel 47, and once hardened, it will provide resistance to forces (e.g., torsional forces) acting on the adhesive coating 85 during implantation or removal, which could cause the adhesive coating 85 to crack or delaminate from the locking member 40. In other words, a portion of the adhesive coating 85 is shielded within the surface channel 47 from mechanical forces that could unintentionally pry, detach, or crack the adhesive coating 85 from the spacer core 5 during implantation and removal. In one example, as... Figure 2B As shown, the at least one surface channel 47 is adjacent to the planar portion 48. The at least one surface channel 47 may include multiple surface channels 47, such as two, three, four, five, six, or up to eight surface channels 47. In some preferred embodiments, the at least one surface channel 47 may be disposed on the outer locking surface 46, directly adjacent to the planar portion 48. In a particularly preferred embodiment, the planar portion 48 has two directly adjacent surface channels 47, one surface channel 47 being directly adjacent to one side of the planar portion 48, and the second surface channel 47 being directly adjacent to the opposite side of the planar portion 48.

[0139] In a specific example, and referring to Figure 3 The cap-shaped member 60 can be formed as a solid body. In an embodiment where the cap-shaped member 60 is a solid body, the cap-shaped member 60 will be attached to the rod 20 after the fluid binder material has been injected into the mold body 120. However, in an alternative embodiment, and referring to... Figures 4A to 4B The cap 60 may include a plurality of windows 12. The windows 12 are configured to allow fluid adhesive material to flow into the mold body 120 to form an adhesive coating 85. The advantage of the cap 60 having windows 12 is that the cap 60 can be attached to the rod 20 before the spacer core 5 is inserted into the mold body 120, while still providing one or more fluid passages at the distal cap end 64 into the mold body 120 for introducing adhesive material into the mold body 120 to form the adhesive coating 85.

[0140] Continue to refer to Figure 4A -B, the plurality of window openings 12 extend from the distal cap end 64 through the cap 60 to the proximal cap end 62. In a particular embodiment, the window openings 12 extend in a direction substantially coaxial with the central axis C. In a particular embodiment, the window openings extend in a substantially linear direction. In a particular example, such as Figure 4AAs shown in -B, the openings 12 are evenly distributed around the cap 60; however, it should be understood that any number of openings 12 of any type of geometry or shape may exist, provided that they provide a fluid passage from the distal end 64 of the cap 60 into the mold body 120.

[0141] Based on this disclosure and with reference to Figure 5A -B describes a mold assembly 100 for forming a temporary adhesive spacer 1, the mold assembly comprising: a mold body 120; a previously described spacer core 5 configured to be disposed within the mold body 120; at least one hole plug 155 configured to be disposed within the at least one locking hole 55 of a locking member 40; and an adapter 180 configured to operatively connect the mold body 120 to a bone adhesive injection device that fills the mold body 120 with adhesive material forming an adhesive coating 85 of the spacer core 1.

[0142] For the purposes of discussing mold assembly 100 and for the sake of brevity, all features and embodiments, combinations and sub-combinations previously described above with respect to spacer core 5 (e.g., rod 20, locking member 40, cap 60, etc.) are considered to be within the scope of the disclosure concerning mold assembly 100 and any subsequent disclosures relating to kits and manufacturing methods.

[0143] As previously described, this disclosure provides a modular aspect of manufacturing the temporary spacer 1, such that at least one benefit is providing surgeons with the ability to customize the length of the temporary spacer 1 to match the patient's anatomy. Thus, according to a particular embodiment, once the surgeon determines the appropriate length of the rod 20, and therefore the appropriate length of the spacer core 5, the mold body 120 is configured such that its length can be customized to match that desired length. Therefore, the mold body 120 is configured to remove a portion of its length if necessary to correspond to the determined length of the temporary spacer 1. In one example, the mold body 120 can be cut to the desired length using surgical scissors or a surgical scalpel. In a particular embodiment, the mold body 120 may include spacer markings or notches corresponding to a specific length (e.g., a 1 mm spacer) to provide visual assistance in determining the desired length. Therefore, it is preferred that the mold body 120 is formed of a material comprising one or more elastomers. Suitable elastomer materials may include, for example, silicone or polyurethane (PUR) or copolymers thereof. In a particular further embodiment, the mold body 120 comprises one or more thermoplastic materials. Suitable thermoplastic materials may include, for example, polytetrafluoroethylene (PTFE), perfluoroalkoxyalkane (PFA), polyethylene, polypropylene, nylon, thermoplastic polyurethane (TPU), or copolymers thereof.

[0144] Regarding the following disclosure of the mold body 120, for the convenience and ease of describing the mold body 120 or its directional relationships and positions, all references will be related to the previously identified directional identifiers for the temporary spacers 1 and spacer cores 5. This is primarily because the mold assembly 100 includes spacer cores 5 disposed within the mold body 120. Therefore, for example, the use of terms such as “axial,” “radial,” “proximal,” “distal,” “longitudinal,” and any derivative thereof is intended to correspond between the previously defined temporary spacers 1 and spacer cores 5 and the mold assembly 100 and mold body 120, which will be further described. For example, as will be described below, the central axis C of the mold body 120 is intended to be the same as previously described with respect to the temporary spacers 1 and spacer cores 5. Thus, the mold assembly 100 includes a mold body 120 that is elongated in the same longitudinal direction L as the rod 20, such that the central axis C defined by the rod 20 also defines the central axis C of the mold body 120. The mold body 120 further defines a proximal mold end 121 and a distal mold end 123 opposite to the proximal mold end 121 along the central axis C, and an outer mold surface 124 extending therebetween.

[0145] The mold body 120 further defines a proximal mold opening 131 at a proximal mold end 121 and a distal mold opening 133 at a distal mold end 123, and an inner mold surface 138 extending therebetween. The inner mold surface 138 defines a mold cavity 136. The mold cavity 136 is configured to have a spacer 5 disposed therein. In other words, the mold assembly 100 includes a spacer core 5 disposed within the mold cavity 136, for example... Figure 5A As shown in the image.

[0146] Continue to refer to Figures 5A to 5B The mold assembly 100 also includes at least one plug 155 configured to be disposed within the at least one locking hole 55 of the locking member 40. The function of the at least one plug 155 is to fill the at least one locking hole 55. Because the locking hole 55 is configured to receive one or more locking screws for securing the temporary spacer 1 to the bone, the function of the at least one plug 155 is to prevent any adhesive material from becoming stuck in the locking hole 55 during the injection of adhesive material into the mold body 120 during the formation of the adhesive coating 85. The at least one plug 155 can be inserted into the at least one locking hole 55 before any adhesive material is injected into the mold body 120, and is configured to be removed from the at least one locking hole 55 once the temporary spacer 1 has been formed.

[0147] In a specific example, the spacer core 5 may include more locking holes 55 than the locking screws will utilize during implantation. As previously described, the locking component 40 of the spacer core 5 may include multiple locking holes 55 to provide the surgeon with various options for securing the temporary spacer 1 to adjacent bone using locking screws or multiple locking screws. Thus, the surgeon or other medical professional can determine which one or how many locking holes 55 will be designated to receive the locking screws before forming the temporary spacer 1, and therefore fill those designated locking holes 55 with a corresponding number of hole plugs 155. Therefore, those locking holes 55 not designated to receive hole plugs 155 can remain open, and adhesive material can thus fill the unused radial holes 55. This can facilitate further strengthening of the adhesion between the adhesive coating 85 and the spacer core 5. Thus, it can be said that a first portion of the plurality of locking holes 55 includes hole plugs 155 disposed therein, and a second portion of the locking holes 55 is open, or does not include hole plugs 155 disposed therein.

[0148] Alternatively, a surgeon or other medical professional may not be able to determine which one or how many locking holes 55 they will need to use to receive the locking screw until they simultaneously assess the anatomy at the implantation site. In such examples, to maintain the availability of each locking hole 55 for the locking screw, each locking hole 55 may be filled with a hole plug 155.

[0149] Continue to refer to Figures 5A to 5B The mold body 120 may include at least one mold hole 145 configured to receive a hole plug 155. The at least one mold hole 145 is also configured to align with at least one locking hole in the locking holes 55 when the spacer core 5 is disposed within the mold body 120. The at least one mold hole 145 extends radially through the mold cavity 136 relative to the central axis C. As previously stated, the directional modifiers used with respect to the mold body 120 should be understood to be used consistently with respect to the spacer core 5, such that the use of the terms "radial" or "radially" or their derivatives is a direction or location defined with respect to the central axis C, and may include both a radially inward direction toward the central axis C and a radially outward direction away from the central axis C. In a particular example, the radial direction R is oriented perpendicular to the central axis C, and in other examples, the radial direction R may be angularly offset from the direction perpendicular to the central axis C but not coaxial with or parallel to the central axis C.

[0150] The function of the at least one mold hole 145 is to allow the at least one plug 155 to be inserted into the at least one locking hole 55 when the spacer core 5 is disposed within the mold body 120, and further to allow the at least one plug 155 to be removed from the at least one locking hole 55 after the temporary spacer 1 is formed (i.e., after the adhesive material has been injected into the mold body 120 and the adhesive coating 85 has been formed) while the temporary spacer 1 is still disposed within the mold body 120. One advantage of configuring the plug 155 to engage with either the at least one locking hole 55 of the spacer core 5 or the at least one mold hole 145 of the mold body 120 is that such a mold assembly 100 can be used as a self-aligning feature. In other words, when the spacer core 5 is disposed within the mold body 120, and when the mold hole 145 and the locking hole 55 of the spacer core 5 are aligned with each other and capable of receiving the plug 155, it can be considered that the mold body 120 and the spacer core 5 are properly oriented and aligned relative to each other, such as, for example, in… Figure 5A As can be seen in the image. Therefore, it can be said that, in a particular example of the mold assembly 100, the at least one hole plug 155 is disposed within and extends through both the at least one locking hole 55 and the at least one mold hole 145.

[0151] In a particular embodiment, the number of mold holes 145 is the same as the number of locking holes 55. In an alternative embodiment, the number of mold holes 145 is less than the number of locking holes 55. As previously described, the spacer core 5 may include a plurality of locking holes 55, which will exceed the actual number of locking screws that the surgeon will utilize. Therefore, in a particular embodiment, the mold body 120 may be configured to include a smaller number of mold holes 145 than the corresponding number of locking holes 55 formed in the spacer core 5. For example, in embodiments where a plurality of locking holes 55 are present, there may be specific locking hole 55 locations in the spacer core 5 with a higher percentage or likelihood of being utilized in the surgical procedure, and specific locking hole 55 locations in the spacer core 5 with a lower percentage of being used. Thus, the mold body 120 may, on the one hand, include the same precise number of mold holes 145 as the locking holes 55 of the spacer core 5, or alternatively may have fewer mold holes. A potential benefit of having fewer mold holes is that this minimizes the number of locations where adhesive material may potentially leak along the mold body 120 (which could potentially compromise the integrity of the resulting adhesive coating 85).

[0152] According to a particular embodiment, the at least one orifice plug 155 may include a plurality of orifice plugs 155, such as two, three, four, five, six, or even up to eight orifice plugs 155. For example, as Figures 5A to 5B As shown, there are two radial plugs 155 configured to fit into each of the two mold holes 145 and the corresponding two locking holes 55 of the spacer core 5.

[0153] Continue to refer to Figures 5A to 5B as well as Figures 9A to 9D and Figures 10A to 10B The mold assembly 100 may also include an adapter 180 configured to operatively connect the mold body 120 to the adhesive injection device 210 to provide a continuous fluid passage from the adhesive injection device 210 to the mold cavity 136 in which the spacer core 5 is disposed for forming an adhesive coating 85 on the spacer core 5, and thus forming a temporary spacer 1. Although the following description and figures of the adapter 180 depict an adapter 180 operatively connected to the distal mold end 123 of the mold body 120, it should be understood that the adapter 180 may also be connected to the proximal mold end 121 of the mold body 120.

[0154] As shown, when connected to the distal mold end 123, the adapter 180 extends from the mold body 120 in the longitudinal direction L, such that the adapter 180 is aligned with the mold body 120 along the central axis C. The adapter 180 defines a proximal adapter end 181 configured to connect to the distal mold end 123, and a distal adapter end 183 opposite to the proximal adapter end 181 along the central axis C. As shown, the distal adapter end 183 is configured to be operatively connected to the adhesive injection device 210. Furthermore, the adapter 180 further defines a distal adapter opening 193 at the distal adapter end 183, and an adapter inner wall 188 extending from the distal adapter opening 193 toward the proximal adapter end 181. The adapter inner wall 188 defines an adapter recess 186. The adapter recess 186 provides a continuous fluid passage from the adhesive injection device 210 to the mold body cavity 136. According to, for example... Figures 9A to 9D In the specific embodiment shown, the inner wall 188 of the adapter may be threaded, such that operably connecting the adapter 180 to the adhesive injection device 210 includes threading the adapter 180 to the adhesive injection device 210. Alternatively, such as Figures 10A to 10B As shown, adapter 180 may include clamps to securely attach adhesive injection device 210 to distal mold end 123.

[0155] Continue to refer to Figures 9A to 9DThe inner wall 188 may further include an adapter reservoir 195 disposed within the adapter recess 186 and extending proximally toward the mold body 120. The adapter reservoir 195 may have a reservoir opening 196 facing the proximal adapter end 181. In a particular embodiment, the distal rod end 24 may be configured to engage with and be disposed therein in the reservoir opening 196. The function of the reservoir opening 196 is to properly center the rod 20 within the mold body when the distal rod end 24 is positioned within the reservoir opening 196, so as to better allow the formation of a uniform adhesive coating 85 along the outer surface 26 of the rod. According to a particular embodiment, the adapter reservoir 195 may have an internally threaded surface, and the distal rod end 24 may be threadedly engaged in the adapter reservoir 195.

[0156] Referring to Figures 5 through 8, in certain cases, the mold body 120 includes a separation device extending generally along the central axis C from the proximal mold end 121 to the distal mold end 123, which is configured to separate the mold body 120. The function of the separation device is to separate or otherwise detach the mold body 120 in order to provide a way for the temporary spacer 1 to detach from the mold body 120 without damage after the adhesive coating 85 has cured.

[0157] In a particular implementation scheme, and with reference to Figure 5A -B and Figure 6 The separation device includes a plurality of perforations 148 arranged in a row, extending axially along the mold body 120 from a proximal mold end 121 toward a distal mold end 123. In a particular embodiment, multiple rows of the plurality of perforations 148 may be present along the mold body 120, for example, as shown in the figure. Figure 6 As shown in the embodiment depicted, two separate rows of perforations 148 may extend axially along the mold body 120 between the proximal mold end 121 and the distal mold end 123.

[0158] Alternatively, and take into consideration Figure 7 The separation device may include at least one material strip 149, which extends axially and is disposed within the mold body 120 between the outer mold surface 124 and the inner mold surface 138. For example, as Figure 7 As shown, there are two material strips 149 extending axially between the proximal mold end 121 and the distal mold end 123.

[0159] In other alternative implementation schemes, such as Figures 8A to 8D As shown, the mold body 120 may include a groove 147 or a plurality of grooves 147 (such as two grooves 147) formed in the outer mold surface 124, the grooves extending axially along the length of the mold body 120 from the proximal mold end 121 toward the distal mold end 123. Reference Figure 8C-D, the mold body 120 may additionally include one or more reinforcing members 152 disposed within the mold body 120, which, in conjunction with the groove 147, are configured to allow controlled guided separation of the mold body 120 along the groove 147. In other words, including the reinforcing member 152 in the mold body 120 guides the mold body to separate along the path of the groove 147, thereby reducing the possibility of the mold body 120 tearing in an unintended direction.

[0160] Referring again to Figures 5 through 8, the mold body 120 may further include one or more tabs 141 disposed at a proximal mold end 121 or a distal mold end 123. These tabs 141 are configured to be grasped, for example, manually or mechanically, and pulled to initiate separation of the mold body 120 along the direction of the separation device. For example, a user may grasp and pull the tabs 141 to apply a force that will cause the separation device to separate the mold body 120 along the defined separation device. For example, when the mold body 120 includes, as... Figures 5A to 5B and Figure 6 When the perforations 148 shown in Figure 148 or the grooves 147 shown in Figure 8 are pulled, pulling the one or more protrusions 141 will apply force along the row of perforations 148 or grooves 147 to the mold body 120, thereby causing the mold body 120 to separate along the separating device. When the mold body 120 includes material strips 149, such as Figure 7 As shown, the user can pull the tab 141, thereby causing the strip 149 to cut the mold body 120 along the lines of the strip 149.

[0161] As previously described, in certain embodiments, the locking member 40 may be offset by an angle θ relative to the central axis C. In embodiments where the locking member 40 is offset, the proximal mold end 121 (where the locking member 40 is disposed in the mold assembly 100) may also be offset by the same angle θ from the central axis C (see, for example...). Figure 9A ).

[0162] According to this disclosure, a kit for forming a temporary adhesive spacer 1 is disclosed. The kit may include a mold body 120, at least one adapter 180, a locking member 40, at least one plug 155, at least one rod 20, and a cap 60. It should be understood that each of the disclosed components may be provided as a separate component in the kit. Alternatively, each kit component may be provided in the kit in a manner consistent with previously described, connected to a corresponding component or plurality of components. For example, the rod 20, locking member 40, and cap 60 have been described as connected elements of the spacer core 5. Thus, any combination of these three components may be provided in the kit in a connected manner, such that the kit may be provided as including a rod 20 connected to the locking member 40, a rod 20 connected to the cap 60, or a rod 20 connected to both the locking member 40 and the cap 60. Again, the kit may be provided with a separate mold body 120 and adapter 180, or alternatively, the adapter 180 may be configured to be connected to the mold body 120.

[0163] In a particular example, a kit may be provided in which the at least one bar 20 may comprise a plurality of bars 20, such as two, three, four, five, six, seven, eight, nine, or ten bars 20. In a preferred embodiment, each of the plurality of bars 20 has a length measured between a proximal bar end and a distal bar end, and each of the plurality of bars 20 has a length different from any other bar length among the plurality of bars 20. In other words, the kit is provided with a plurality of bars 20 of different lengths. As previously disclosed, in one aspect, the temporary spacer 1 of this disclosure is configured to be modular with respect to its length and the surgeon's ability to determine and customize the length of the spacer core 5. Thus, by providing a plurality of bars 20, wherein each of the bars 20 has a different length, the surgeon is able to customize the spacer core 5 to have a desired length that most closely approximates the patient's anatomical dimensions.

[0164] Alternatively, as previously described, the rod 20 may include an outer surface 26 that includes a substantially or even entirely threaded surface 28. In such cases, the kit may include a single rod 20 that includes a continuous threaded surface 28, and the surgeon may determine the appropriate length of the rod 20 and cut it to the desired length.

[0165] The kit may also include at least one locking bone screw, or, for example, the kit may include multiple locking screws, such as two, three, four, five, six, seven or eight locking screws, which are configured to be disposed in locking holes 55 and to secure the temporary spacer 1 to the bone.

[0166] refer to Figure 11 The kit may include an insertion device 300 configured to be operatively coupled to the locking member 40. For example... Figure 11 As shown, by placing the insertion screw 303 into the proximal locking recess 53, the insertion device 300 is operatively coupled to the proximal locking end 42.

[0167] This disclosure further describes a method for forming an antimicrobial elution temporary adhesive spacer. The method may include the following steps:

[0168] A spacer core is inserted into the inner cavity of the mold body. The spacer core includes a rod and a locking member connected to the rod, wherein the locking member includes at least one locking hole.

[0169] An adapter is used to connect the bone cement injection device to the mold body to provide a fluid pathway from the bone cement injection device to the cavity of the mold body;

[0170] At least one plug is placed into the at least one locking hole;

[0171] Bone cementing material, comprising one or more antimicrobial agents, is injected into the cavity of the mold body through a fluid passage along at least a portion of the outer surface of the rod.

[0172] Bone cementitious material is cured onto the surface of the outer rod to form a cementitious coating, thereby forming a temporary cementitious spacer that is resistant to microbial elution;

[0173] Disconnect the bone cement injection device from the mold body;

[0174] Remove the at least one hole plug from the at least one locking hole; and

[0175] Separate the mold body from the antimicrobial wash-off temporary adhesive spacer.

[0176] The method may also include, prior to the step of inserting the spacer core 5 into the mold cavity 136, connecting the rod 20 to the locking member 40, such as, as previously described, operably connecting the proximal rod end 22 to the distal locking end 44.

[0177] As previously stated, rod 20 has a rod length, and the method may further include removing a portion of the length of rod 20 from either the proximal rod end 22 or the distal rod end 24. In a preferred embodiment, after the removal step, the length of spacer core 5 is less than or equal to the length of mold body 120. Additionally, as previously stated, mold body 120 has a length, and the method may further include removing a portion of the length of mold body 120 from either the proximal mold end 122 or the distal mold end 124.

[0178] According to another embodiment, the mold body 120 includes at least one mold hole 145, and the step of inserting the spacer core 5 into the mold cavity 136 may further include aligning the at least one mold hole 145 with the at least one locking hole 55. Additionally, the step of disposing of at least one plug 155 into the at least one locking hole 55 may further include disposing of the at least one plug 155 into both the at least one mold hole 145 and the at least one locking hole 55. In a particular other embodiment, where the at least one locking hole 55 comprises a plurality of locking holes 55, the method includes disposing of a plurality of plugs 155 into each of the plurality of locking holes 55. Alternatively, where the at least one locking hole 55 comprises a plurality of locking holes, the method may include inserting at least one plug 155 into the plurality of locking holes 55 such that at least one of the plurality of locking holes 55 does not receive the plug 155. In embodiments where at least one locking hole 55 does not receive the plug 155, the step of injecting bone cement material may include filling the at least one locking hole 55 that does not receive the plug 155 with the bone cement material. In other embodiments, where the at least one mold body hole 145 includes a plurality of mold holes 145, the method includes disposing the plurality of hole plugs 155 into each of the plurality of mold holes 145.

[0179] As previously described, in a particular embodiment, the cap 60 is configured to attach to the distal rod end 24, such that in this case, the spacer core 5 can be said to include the rod 20, the locking member 40, and the cap 60. Therefore, the method may also include the step of attaching the cap 60 to the distal rod end 24 of the rod 5. Additionally, as described, if the distal rod end 24 includes a threaded surface 28, this step may include screwing the cap 60 onto the threaded surface 28 of the distal rod end 24. As previously described, the cap 60 may include a plurality of windows 12 extending through the cap 60. Therefore, if the cap 60 includes windows 12, the step of attaching the cap 60 to the rod 20 may occur at any time before the step of injecting the bone cement material and after the step of disengaging the bone cement injection device 210 from the mold body 120. Therefore, if the cap 60 includes windows 12, the step of injecting the bone cement material may include injecting the bone cement material through the windows 12.

[0180] Now for reference Figure 12A further embodiment of a mold assembly 400 for forming a temporary adhesive spacer 1 is described. The mold assembly 400 includes a mold body 520 and a temporary spacer core 405 configured to be disposed within the mold body 520. The spacer core 405 is configured to provide a structural frame for the temporary spacer 1 and includes a rod 420, a locking member 440, and a cap 460. The mold assembly includes at least one orifice plug 555 configured to be disposed within at least one locking orifice 455 of the locking member 440. The mold assembly 400 also includes an adapter 580 configured to operatively connect the mold body 520 to a bone adhesive injection device that fills the mold body 520 with adhesive material forming an adhesive coating 485 of the spacer core 1. The mold assembly 400 may also include a proximal plug member 470 configured to engage with a proximal end of the locking member.

[0181] For the purposes of discussing mold assembly 400 and for the sake of brevity, all features, embodiments, combinations, and sub-assemblies described above with respect to spacer core 5 (e.g., rod 20, locking member 40, cap 60, etc.) are considered to be within the scope of the disclosure relating to mold assembly 400 and any subsequent disclosures relating to kits and manufacturing methods. The following disclosure will focus on mold assembly 400 and its components relative to the above references. Figures 1A to 11 The differences between the mold components and parts are described.

[0182] The rod 420 is constructed similarly to the rod 20 described above. The rod 420 defines a proximal rod end 22, a distal rod end 24 opposite the proximal rod end 22 along the central axis C, and an outer rod surface 26 extending from the proximal rod end 22 to the distal rod end 24. The proximal rod end 22 is configured to attach to the locking member 440. For example, a portion of the outer rod surface 26 at the proximal rod end 22 may define a locking feature, such as a threaded surface 28, which can lock with a complementary locking feature of the locking member 440 (such as an inner distal locking surface 33). The distal rod end 24 is configured to attach to the cap 460. For example, a portion of the outer rod surface 26 at the distal rod end 24 may define a locking feature, such as a threaded surface 28, which can lock with a complementary locking feature of the cap 60 (such as a threaded inner cap surface 71). In this embodiment, the outer rod surface 26 is preferably smooth and has no protrusions between the threaded surfaces 28 at the proximal rod end 22 and the distal rod end 24. For example, the outer rod surface 26 in this embodiment may not have a centering member, such as the centering member 31 described above.

[0183] Now refer to Figure 13A to Figure 13DThe locking member 440 is constructed similarly to the locking member 40 described above. Therefore, the locking member 440 may include the various associated features described above, including, for example, a proximal locking end 42, a proximal locking opening 50, a proximal locking inner surface 51, a proximal locking recess 53, a distal locking end 44, a distal locking opening 32, an inner distal locking surface 33, a distal locking recess 35, an outer locking surface 46, one or more locking holes 55, and an offset angle θ.

[0184] However, a difference in this embodiment is that the outer locking surface 46 may define one or more protrusions 49 that define radially outward portions of the one or more locking holes 55. These one or more protrusions 49 may also be referred to as “boobs” or “islands” and may each define an outer protrusion surface 451 that is spaced outwardly from the main recessed surface portion 449 of the outer locking surface 46 by a distance R1 measured in the radial direction R. When the spacer core 405 is disposed within the mold body 520, these one or more protrusions 49 advantageously increase the clearance or void volume between the mold body 520 and the locking member 440. This increased clearance or void volume provides additional space along the outer locking surface 46 to receive and be occupied by adhesive material injected into the mold body 520 for forming the adhesive coating 85.

[0185] In the illustrated embodiment, the one or more protrusions 49 may include a first pair of radially opposing protrusions 49a along at least a first locking hole 55a and a second pair of radially opposing protrusions 49b along at least a second locking hole 55b. It should be understood that each protrusion 49 may extend along a single locking hole 55 or along multiple locking holes 55. Additionally or alternatively, the one or more protrusions 49 may extend along other features, such as along the proximal locking end 42. For example, the one or more protrusions 49 may include a proximal mounting protrusion 49c configured to engage with a complementary geometry of an instrument, such as an insertion instrument 300. The proximal mounting protrusion 49c may define one or more surface channels 447 configured to expel gas (e.g., air) as the adhesive 85 advances through the mold. The one or more surface channels 447 can also advantageously provide a visual indication of when the mold is filled (or at least substantially filled) with adhesive 85, and can additionally provide a simplified “clean” feature through which excess adhesive 85 can be extruded from the mold and discarded. As shown, the proximal mounting protrusion 49c can define a single surface channel 447 having a dovetail cross-sectional profile, which can be configured to retain the adhesive 85 therein after curing. Alternatively, the surface channel 447 can have other profile shapes, such as a U-shaped or V-shaped cross-sectional profile as non-limiting examples. It should be understood that the proximal locking end 42 is preferably configured to selectively mount to multiple instruments, such as various insertion instruments 300 (e.g., various aiming arms, etc.). In this way, the spacer core 405 can be mounted to various types of surgical instruments based on patient needs.

[0186] The one or more protrusions 49 may also define retaining structures for engagement with the injected adhesive after hardening, to enhance the stability of the engagement between the adhesive coating 85 and the locking member 440. Such retaining structures may include inwardly tapering surfaces or “notches” along one or more different sides and / or ends of the protrusions 49. For example, one or both of the first pair of radially opposing protrusions 49a may include tapering side surfaces 453 that taper inward toward each other as they extend radially inward toward the central axis C. Alternatively, one or both of the second pair of radially opposing protrusions 49b may include tapering side surfaces 457 that taper inward toward each other as they extend radially inward toward the central axis C. These tapering side surfaces 457 may also define channels, similar to the channels 47 described above, that may receive portions of the adhesive coating 85 and provide shielding against mechanical forces occurring during implantation and removal. Additionally, the tapered side surfaces 453, 457 allow the corresponding outer protrusion surface 451 to radially overhang the corresponding portion of the main recessed surface 449. This facilitates retention of the adhesive coating 85 along the locking member 440, particularly during implantation or removal under forces (e.g., torsion) acting on the adhesive coating 85 that could cause it to crack or delaminate from the locking member 440. It should be understood that other retention geometry may be employed along the one or more protrusions 49.

[0187] like Figure 13D As shown, the proximal plug member 470 may be configured to temporarily engage with the proximal locking inner surface 51 of the locking member 440. The proximal plug member 470 may include a distal insertion portion 472 for insertion into the proximal locking recess 53. Preferably, the distal insertion portion 472 is externally threaded for threaded engagement with the internal threads of the proximal locking inner surface 51. Thus, during adhesive injection, the proximal plug member 470 may block and prevent adhesive 85 from flowing into the proximal locking opening 50. Therefore, the proximal plug member 470 may also be referred to as a "threaded protector" for the proximal locking end 42 of the locking member 440.

[0188] Referring now to Figures 14A to 14C, the cap-shaped member 460 is constructed similarly to the cap-shaped member 60 described above. Therefore, the cap-shaped member 460 may include the various associated features described above, including, for example, a proximal cap-shaped member end 62, a proximal cap-shaped member opening 70, an inner cap-shaped member surface 71, a cap-shaped member recess 73, a distal cap-shaped member end 64, and an outer cap-shaped member surface 66. However, in this embodiment, the cap-shaped member 460 may include a distal cap-shaped member opening 75 instead of a window 12, which is preferably centered relative to the central axis C. The distal cap-shaped member end 64 is defined by a distal cap-shaped member portion 461, which is connected to the proximal hub portion 463 by a plurality of arms 465 circumferentially spaced apart from each other around the central axis C. Thus, the cap 460 defines openings or channels 466 circumferentially positioned between the arms 465 and in fluid communication with the distal cap opening 75 to facilitate the flow of adhesive 85 therethrough. One advantage of this configuration of the cap 460 is that the channels 466 can be wider and present a smaller contact surface area along the body of the cap 460 compared to a window (such as the aforementioned window 12), thus providing less resistance to the adhesive 85 during injection. The proximal hub portion 463 may define the proximal cap end 62, the cap opening 70, the inner cap surface 71, and the cap recess 73, which may be constructed as described above.

[0189] As shown, the cap 460 may have three (3) arms, which are preferably circumferentially spaced evenly (i.e., at 120-degree intervals) from each other about a central axis C. It should be understood that in other embodiments, the cap 640 may have one (1), two (2), four (4), five (5), or more than five arms 465, which may be evenly or unevenly spaced from each other. As shown, the arms 465 preferably define a distal surface 467 that tapers to a leading edge 469 to reduce resistance (e.g., drag) to the adhesive 85 injected through the distal cap opening 75. The leading edge 469 of the arms 463 may also taper radially inward from the distal cap portion 461 to the proximal hub portion 463. The distal surface 471 of the proximal hub portion 463 may be circular or otherwise configured to facilitate the flow of adhesive 85 through the cap 460.

[0190] The cap-shaped member 460 may define a maximum cap-shaped member cross-sectional area similar to the maximum cross-sectional area of ​​the temporary spacer 1. For example, the maximum cap-shaped member cross-sectional area may be in the range of 70% to 100% of the maximum cross-sectional area of ​​the temporary spacer 1, or more particularly in the range of 85% to 95% of the maximum cross-sectional area of ​​the temporary spacer 1, or preferably in the range of about 88% to about 92% of the maximum cross-sectional area of ​​the temporary spacer 1. It should be understood that, for the foregoing exemplary range, the maximum cross-sectional area of ​​the temporary spacer 1 may be defined by the locking member 440.

[0191] Now for reference Figure 15A As shown in Figure 15C, the mold body 520 is constructed similarly to the mold body 120 described above for forming the temporary spacer 1. Therefore, for example, the mold body 520 may include the various associated features described above, including, for example, a proximal mold end 121, a proximal mold opening 131, an outer mold surface 124, a distal mold end 123, a distal mold opening 133, a mold cavity 136, a mold inner surface 138, and one or more mold holes 545. Similar to the mold body 120 described above, the mold body 520 of this embodiment is configured such that its length can be customized to match the desired length of the spacer core 405. Therefore, the mold body 520 preferably includes visual markings, such as a series of marks 525 spaced at intervals corresponding to a specific length (e.g., 1 mm intervals), to provide visual assistance in determining the desired length. The marks 525 may be drawn, sprayed, etched, anodized, and / or engraved on the outer surface 524 of the mold. Preferably, the mold body 520 is also formed of a translucent or at least partially translucent material, thereby allowing the surgeon or other qualified medical professional to observe the spacer core 405 and / or adhesive disposed within the mold body 520 during the formation process. It should be understood that, based on the selected length of the rod 420, when the spacer core 405 is positioned adjacent to the mold body 520, the distal cap-shaped end 64 is preferably substantially aligned with one of the marks 525. Thus, the surgeon can visually reference the distal cap-shaped end 64 adjacent to the mold body 520 to identify the desired customized length of the mold body 520. Furthermore, the surgeon may optionally designate one of the visual marks as the desired location for cutting the mold body 520. The mold body 520 preferably defines a weakened portion, such as a notch, along the mark 525 to facilitate or otherwise guide the cutting at the selected mark 525.

[0192] Referring now to Figures 16A through 16C, the mold body 520 is configured to cut to a desired length using a cutting device (such as the multi-functional cutting device or “cutter” 550 of the mold assembly 400). It should be understood that the mold body 520 is also configured to facilitate cutting to a desired length using other cutting devices (as non-limiting examples, such as surgical scissors or scalpels). The multi-functional cutter 550 of this embodiment includes a first support member 552 having a guide forming 554 for removable engagement with the mold body 520 for multi-functional cutting (e.g., selective multi-directional cutting), as described in more detail below. The cutter 550 includes a second support member 556 that carries a cutting member such as a blade 558 and is pivotally connected to the first support member 552 via a hinge structure 560. In this embodiment, the hinge structure 560 is a compliant (i.e., flexible) member that may be defined by a plurality of gaps or holes configured to cause bending along the hinge structure 560. The hinge structure 560 can be integrated with the first support member 552 and the second support member 556, as shown in the figure.

[0193] The guide forming member 554 may be configured to perform multi-directional cutting by defining a first mounting forming member and a second mounting forming member for performing the first and second corresponding cuts along a first and a second corresponding cut direction. For example, the first mounting forming member may be a first pair of slots 562 aligned along a first guide axis X1, which is configured to be substantially coaxial with a central axis C as the mold body 520 extends through the first pair of slots 562, thereby aligning the blade 558 (and thus the first cut direction) in a transverse direction T substantially perpendicular to the longitudinal direction L. Thus, the mold body 520 can be inserted through the first pair of slots 562 for cutting the mold body 520 to a desired length. The guide forming member 554 may also include a reference forming member, such as one or more visual protrusions 566 defining a gap therebetween, which may be configured to provide the surgeon with a visual reference to the cutting path of the blade 558. Thus, when performing a length-determining cut on the mold body 520, the surgeon can use the reference forming member 566 to align the cutting path with a desired mark 525. The second mounting element may be a second pair of slots 564 aligned along a second guide axis X2, which is configured to be substantially coaxial with the central axis C as the mold body 520 extends through the second pair of slots 564, thereby aligning the blade 558 in the longitudinal direction L (and thus the second cutting direction). In this way, the mold body 520 can be inserted through the second pair of slots 564 for longitudinally cutting (e.g., slicing) the mold body along its length to disengage the mold body 520 from the temporary spacer 1 after the adhesive coating 85 has cured.

[0194] Now for reference Figure 17 In another embodiment of the cutter 550, the hinge structure 560 may employ a pivot pin 568 that pivotally engages the first support member 552 and the second support member 556. In this embodiment, the proximal ends 570 of the first support member 552 and the second support member 556 may be pressed toward each other about the pivot pin 568, which serves as a fulcrum, to open the cutter 550 for insertion into the mold body 520 through one of the first pair of slots 562 or the second pair of slots 564. The cutter 550 of this embodiment may otherwise be constructed in a manner similar to the cutter 550 described above with reference to Figures 16A to 16C.

[0195] Now for reference Figures 18A to 18C The adapter 580 is constructed in a manner generally similar to the adapter 180 described above for operatively connecting the mold body 520 to a component of the adhesive injection device 210, such as the injection tube 212 of the syringe 210. Therefore, the adapter 580 includes various features of the adapter described above, including a proximal adapter end 181 configured to connect to the distal mold end 123, and a distal adapter end 183 opposite to the proximal adapter end 181 along the central axis C. As described above, the distal adapter end 183 is configured to operatively connect to the injection tube 212. Furthermore, the adapter 580 further defines a proximal adapter opening 191 at the proximal adapter end 181, a distal adapter opening 193 at the distal adapter end 183, and an adapter inner wall 188 extending from the proximal adapter opening 191 to the distal adapter opening 193. The adapter inner wall 188 defines an adapter cavity 186 that provides a continuous fluid passage from the injection tube 212 to the mold body cavity 136. The adapter 580 also defines an adapter outer surface 587, which may define a mounting form, such as an external recess 589, which may extend circumferentially around the circumference or part of the circumference of the adapter 580.

[0196] In this implementation plan, such as Figure 18BAs shown, the adapter 580 may include one or more internal retaining features, such as a first retaining feature 582 and a second retaining feature 584, which are configured to securely clamp the mold body 520 and the adhesive injection device 210 respectively when fully inserted or "placed" within the adapter cavity 186. For example, the first retaining feature 582 and the second retaining feature 584 may each be an annular retaining ring having a plurality of fingers or teeth 586 extending radially inward toward the central axis C. The retaining rings 582, 584 may reside within corresponding annular recesses 585 within the adapter inner wall 188. The teeth 586 may have a geometry configured to non-destructively clamp the respective outer surfaces of the mold body 520 and the injection tube 212. For example, the teeth 586 may be formed of a flexible material that can clamp the mold body 520 and the injection tube 212 respectively, wherein the holding force is sufficient to “hold” the mold body 520 and the injection tube 212 in the proper position within the adapter cavity 186 during the adhesive injection process, but also allows the mold body 520 and the injection tube 212 to be subsequently non-destructively disengaged from the teeth 586.

[0197] Preferably, the adapter 580 further includes one or more release members, such as a first release member 588 for releasing the mold body 520 from the adapter 580 and a second release member 590 for releasing the injection tube 212 from the adapter 580. One or both of the first release member 588 and the second release member 590 may include a tubular insert body 592 and an actuator, such as an actuating flange 594 extending radially outward from the tubular insert body 592. The first release member 588 and the second release member 590 in… Figure 18B The figures are shown in the corresponding intermediate positions. By pressing the corresponding actuating flange 594 in a manner that pushes the tubular insert body 592 further into the adapter cavity 186, the inner end 596 of the tubular insert body 592 is pressed against the teeth 586 of the corresponding retaining rings 582, 584, and the release members 588, 590 can be selectively actuated to the release position. Thus, when in the release position, the tubular insert body 592 can deflect the teeth 586 to disengage from the mold body 520 or the injection tube 212 respectively, thereby allowing the surgeon to retract the corresponding mold body 520 or injection tube 212 from the adapter 580 as needed.

[0198] Preferably, the tubular insert body 592 defines internal surfaces 598 that define corresponding cavities 599, the dimensions of which are configured to tightly receive one, but not both, of the mold body 520 and the injection tube 212. For example, the internal surface 598 of the first release member 588 may define an inner diameter D1 substantially equal to the outer diameter of the distal mold end 123, such that the distal mold end 123 can be tightly received within the cavity 599 of the first release member 588. This diameter may be larger than the inner diameter D2 of the internal surface 598 of the second release member 590, which in turn may be substantially equal to the outer diameter of the injection tube 212, such that the injection tube 212 can be tightly received within the cavity 599 of the second release member 590. Thus, the distal mold end 123 will not fit within the cavity 599 of the second release member 590, thereby ensuring that the distal mold end 123 is inserted into the appropriate end of the adapter 580 (i.e., the proximal adapter end 181). Therefore, once the distal mold end 123 is inserted into the adapter 580, the injection tube 212 can only be inserted into its associated end (i.e., the distal adapter end 183) of the adapter 580. It should be understood that in other embodiments, the injection tube 212 may have an outer diameter larger than the outer diameter of the distal mold end 123. In yet another embodiment, the injection tube 212 and the distal mold end 123 may have substantially equal outer diameters D1, D2, and each may fit tightly within the cavities 599 of the two release members 588, 590.

[0199] It should be understood that the distal adapter end 183 is preferably configured to connect with a standard syringe, which provides significant benefits such as the ability to use the adapter 580 to perform injections with a wide variety of injection devices employing such standard syringes.

[0200] Now for reference Figures 19A to 19B The mold assembly 400 may include a clamping or "handle" member 600, such as for use with the adapter 580 to provide clamping support to the surgeon during adhesive injection. The handle member 600 may include a central mount 602 and a pair of extensions 604 extending opposite it in a lateral direction T. The central mount 602 may define a slot 605 for engaging complementary structures of the adapter 580, such as an external recess 589. The extensions 604 may include clamping formations 606, such as fan-shaped notches configured to provide finger retention, which provide clamping support for the surgeon's fingers to effectively grasp the adapter 580 during adhesive injection.

[0201] Now refer to Figure 20A to Figure 20CThe mold assembly 400 may include a forming tool 610 for removing excess adhesive 85 from the distal end of the temporary spacer core 405. The forming tool 610 has a proximal end 612, an opposing distal end 614 spaced apart from the proximal end 612 in the longitudinal direction L, and a clamping portion 616 extending from the distal end 614 toward the proximal end 612. The clamping portion 616 preferably defines a clamping feature 618, such as a recess, knurling, etc., to facilitate surgical manipulation. The forming tool 610 includes a removal forming member 620 at the proximal end 612. Figure 20C As shown, the cleaning form 620 is configured to be inserted into the mold cavity 136 at the distal mold end 123 to engage the distal cap end 64. The cleaning form 620 defines an engagement surface 622, which preferably has a concave geometry complementary to the geometry of the distal end 64 of the cap 460. The cleaning form 620 also defines a plurality of channels 624 for conveying excess adhesive away from the cap 460. The channels 624 may extend along a helical path and may be in fluid communication with a tool cavity 626 extending from the cleaning form 620 to the distal end 614. The channels 624 are preferably configured to receive and contain excess adhesive 85 detached from the cap 460, and also preferably guide the excess adhesive 85 inward into the tool cavity 626 for containment. It should be understood that although channel 624 may guide some of the excess adhesive through cavity 626 and away from distal end 614, such transport away from distal end 614 is not necessary for forming tool 610 to adequately remove excess adhesive from cap 460.

[0202] Now for reference Figure 21 The mold assembly 400 may be disposed in the kit 700 for forming the temporary adhesive spacer 1. The kit 700 of this embodiment may include a mold body 520, at least one adapter 580, a locking member 440, at least one plug 555, at least one rod 420, and a cap 460. It should be understood that various combinations of the foregoing components may optionally be provided connectedly in the kit 700, as described above. In some embodiments of the kit 700, the at least one rod 420 may include a plurality of rods 420, such as two (2), three (3), four (4), five (5), six (6), seven (7), eight (8), nine (9), ten (10), or more than ten rods 420. In a preferred embodiment, each of the plurality of rods 420 has a length different from the length of each of the other rods 420. Therefore, kit 700 allows surgeons or other medical professionals to select a bar 420 with a desired bar length for forming a temporary spacer 1 with a desired spacer length, thereby allowing surgeons to customize the spacer core 405 based on the patient's specific anatomy.

[0203] It should be understood that kit 700 may be a disposable kit containing the entire system for forming the temporary spacer 1. In such embodiments, kit 700 may include a adhesive injection device 210, an adhesive mixing device, and one or more pre-packaged quantities of adhesive material. Disposable kit 700 of such embodiments may also include components for implanting the formed temporary spacer 1 into the patient's anatomy. For example, kit 700 may include an insertion device 300 and an accompanying insertion screw 303 for attachment to the proximal end of locking component 440. Kit 700 may also include at least one locking bone screw, such as multiple locking screws, such as two (2), three (3), four (4), five (5), six (6), seven (7), eight (8), or more than eight locking screws configured to be disposed in locking holes 555 and to secure the temporary spacer 1 to the bone.

[0204] Kit 700 can be used in methods of performing surgical revision surgery, such as for the removal and temporary replacement of implants. The surgery may include methods of forming or otherwise constructing an antimicrobial eluting temporary adhesive spacer 1. An example of such a method for constructing a temporary spacer includes the step of selecting a rod 420 of a desired length from the plurality of rods 420 in kit 700, as a non-limiting example, such as selecting from seven (7) rods 420 having corresponding lengths of 285 mm, 315 mm, 330 mm, 345 mm, 360 mm, 375 mm, and 405 mm. The surgeon can assemble the spacer core 405 by attaching the proximal rod end 22 of the selected rod 420 to the locking member 440 and the distal rod end 24 to the cap 460 in the manner described above. The desired length of the mold body 520 can be determined, for example, by placing the assembled spacer core 405 next to the mold body 520 and marking the mold body 520 with a mark 525 aligned with the distal cap end 64. The surgeon prepares the mold body 520 for cutting at the corresponding mark 525 by inserting the mold body 520 into the first pair of slots 562 of the cutter 550, aligning the reference forming element 566 with the corresponding mark 525. The mold body 520 can then be cut at the mark 525 using a blade 558. The cutter 550 can then be removed from the mold body 520.

[0205] The surgeon can then begin assembling the mold, such as by inserting the assembled spacer core 405 through the proximal mold opening 131 into the cavity 136. The surgeon can align the locking hole 55 of the locking member 440 with the associated mold hole 145 in the mold body 520 and insert one or more plugs 555 through the corresponding mold hole 145 and the corresponding locking hole 55. It should be understood that each plug 555 ensures proper orientation of the spacer core 405 in the mold body 520 and also prevents the spacer core 405 from moving relative to the mold body 520 in response to pressure generated during the injection of bone cement into the mold body 520. An adapter 580 can be coupled to the mold body 520. Specifically, the distal mold end 123 can be inserted into the proximal adapter opening 191 until it is fully positioned within the adapter cavity 186. At this stage, the mold can be characterized as fully constructed, or at least substantially fully constructed. The constructed mold can be set aside while the bone cement is mixed and prepared for injection into the mold.

[0206] To facilitate adhesive injection, the injection tube 212 of the injection device 210 can be inserted into the distal adapter opening 193 until it is fully positioned within the adapter cavity 186 and in fluid communication with the mold cavity 136. Preferably, once the adhesive is mixed, the injection device 210 injects the mixed adhesive through the injection tube 212 into the mold, specifically through the distal cap opening 75 and along the channel 466 into the annular space between the outer surface 26 of the rod and the inner mold surface 138, preferably at a constant rate. During injection, the surgeon preferably observes the adhesive advancing through the mold through the translucent mold body 520. Injection continues such that the adhesive is pushed along the main recessed surface portion 449 of the locking member 440 and around one or more of its protrusions 49. Preferably, injection continues at least until the adhesive reaches the channel 447 at the proximal end of the locking member 440. If necessary, a proximal plug member 470 can be inserted into the proximal locking inner surface 51 to prevent the threads therein from contacting the adhesive.

[0207] After the mold is filled, the mold body 520 can be removed from the adapter 580, which can be facilitated by pressing the first release member 588 as described above. Once removed, the adapter 580 and the injection device 210 can be discarded. After the adapter 580 is removed from the mold body 520, a forming tool 610 is used to remove excess adhesive from the distal cap-shaped end 64. Specifically, the removal forming member 620 can be inserted into the mold cavity 136 such that the mating surface 622 engages the distal cap-shaped end 64, as described above. The surgeon can rotate the forming tool 610 about the central axis C to remove excess adhesive. It should be understood that the removal step can be repeated several times as the adhesive cures and may have to be repeated during the curing process until the adhesive reaches a dough-like state. Preferably, the distal cap-shaped end 64 will be visible at the end of the removal step. The fully assembled injection mold can be set aside until the bone adhesive has completely cured.

[0208] After the adhesive has cured, the surgeon can remove the one or more orifice plugs 555 and proximal plug member 470 to prepare for removal of the mold body 520 from the spacer core 405. For removal, the mold body 520 can be inserted into the second pair of slots 564 of the cutter 550, and a first longitudinal slit can be cut along the length of the mold body 520 using a blade 558. After cutting the first longitudinal slit, the mold body 520 can be rotated relative to the cutter 550 about a central axis C, such as by 180 degrees, and a second longitudinal slit can be cut along the length of the mold body 520 in a similar manner. After cutting the first and second full-length slits, the surgeon can grasp the opposite portions of the cut mold body and separate the mold body from the spacer core 405. Figure 22 The temporary spacer 1 formed according to the aforementioned steps is shown in the figure. The surgeon can then prepare the temporary spacer 1 for implantation, such as by attaching the temporary spacer 1 to the insertion device 300, as described above.

[0209] It should be understood that the various features of the aforementioned temporary spacer 1, mold assembly, and components are provided as exemplary features of a surgical system. These features may be adjusted as needed without departing from the scope of this disclosure.

[0210] It should also be understood that when numerical prepositions (e.g., "first," "second," "third") are used herein to refer to an element, component, dimension, or feature thereof (e.g., "first" component, "second" component, etc.), such numerical prepositions are used to distinguish the element, component, dimension, and / or feature from another such element, component, dimension, and / or feature, and are not limited to the specific numerical preposition used in this case. For example, without departing from the scope of this disclosure, a "first" component may also be referred to as a "second" component in different contexts, as long as the component remains appropriately distinguished in the context in which the numerical preposition is used.

[0211] Although this disclosure has been described in detail, it should be understood that various changes, substitutions, and modifications may be made herein without departing from the spirit and scope of the invention as defined by the appended claims. Furthermore, the scope of this disclosure is not intended to be limited to the specific embodiments described herein. Specifically, one or more features from the foregoing embodiments may be used in other embodiments herein. Those skilled in the art will readily appreciate that existing or future processes, machines, manufactures, material compositions, apparatuses, methods, or steps may be utilized according to this disclosure to perform substantially the same function or achieve substantially the same results as the corresponding embodiments described herein.

Claims

1. A temporary adhesive spacer, comprising: Spacer core, the spacer core comprising: A rod, the rod defining a central axis of the spacer core and having a proximal rod end and a distal rod end opposite the proximal rod end along the central axis, the rod further defining an outer rod surface extending between the proximal rod end and the distal rod end; A locking member defining a distal locking end and a proximal locking end opposite the distal locking end along the central axis, the distal locking end being attached to the rod at the proximal rod end; the locking member further defining at least one locking hole extending radially through the locking member relative to the central axis, the at least one locking hole being configured to receive a locking screw; and A cap-shaped member defining a proximal cap-shaped end and a distal cap-shaped end opposite the proximal cap-shaped end along the central axis, the proximal cap-shaped end being attached to the distal rod end; and An adhesive coating that surrounds at least a portion of the surface of the outer rod, the adhesive coating comprising a mixture of an adhesive material and one or more antimicrobial agents; The cap-shaped member is configured to define the front end of the temporary adhesive spacer during implantation, and The cap-shaped member includes a distal cap-shaped member opening centrally positioned around the central axis, the cap-shaped member defining a plurality of channels in fluid communication with the distal cap-shaped member opening and extending from the distal cap-shaped member opening toward the proximal cap-shaped member end.

2. The temporary adhesive spacer according to claim 1, wherein: The outer rod surface includes a threaded surface at the proximal rod end, and the distal locking end defines a distal locking opening configured to thread-engage with the proximal rod end; and The outer rod surface includes another threaded surface at the distal rod end, and wherein the proximal cap end defines a proximal cap opening configured to thread into the distal rod end.

3. The temporary adhesive spacer according to claim 1 or claim 2, wherein the locking member extends axially from the distal locking end to the proximal locking end such that the proximal locking end is angularly offset relative to the central axis in the range of 5 to 20 degrees.

4. The temporary adhesive spacer according to claim 1 or claim 2, wherein the cap-shaped member is defined in a cross-sectional area in a plane perpendicular to the central axis, and wherein the cross-sectional area of ​​the cap-shaped member is at least 90% of the maximum cross-sectional area of ​​the temporary adhesive spacer.

5. The temporary adhesive spacer according to claim 1 or claim 2, wherein the locking member defines an outer locking surface extending from the proximal locking end to the distal locking end.

6. The temporary adhesive spacer according to claim 5, wherein a majority of the outer locking surface defines a main recessed surface portion and at least one protrusion surrounding the at least one locking hole, the at least one protrusion defining an outer surface radially spaced outward from the main recessed surface portion, wherein the adhesive coating: (1) extends radially outward from the main recessed surface portion and (2) is flush with the surface of the outer protrusion.

7. The temporary adhesive spacer of claim 6, wherein the main recessed surface portion extends from the distal locking end toward the proximal locking end and also extends around the entire outer circumference of the locking member.

8. The temporary adhesive spacer according to claim 6 or claim 7, wherein the at least one protrusion defines opposing sides that taper inward toward each other and toward the central axis.

9. The temporary cement spacer of claim 1 or claim 2, wherein the cap defines: a distal cap portion defining the distal cap opening. The proximal hub is spaced proximally from the distal cap-shaped portion; and a plurality of arms extending proximally from the distal cap portion to the proximal hub, wherein the channel is circumferentially defined between corresponding adjacent arms in the arms.

10. A mold assembly for forming temporary spacers, comprising: Spacer core, the spacer core comprising: A rod, the rod defining a central axis of the mold assembly and having a proximal rod end and a distal rod end opposite the proximal rod end along the central axis, the rod further defining an outer rod surface extending between the proximal rod end and the distal rod end; A locking member defining a distal locking end and a proximal locking end opposite the distal locking end along the central axis, the distal locking end being attached to the rod at the proximal rod end; the locking member further defining at least one locking hole extending radially through the locking member relative to the central axis, the at least one locking hole being configured to receive a locking screw; and A mold body extending along a central axis defines a proximal mold end and a distal mold end opposite to the proximal mold end along the central axis, the proximal mold end including a proximal mold opening and the distal mold end including a distal mold opening, wherein the mold body defines an inner mold surface extending between the proximal mold opening and the distal mold opening, the inner mold surface defining a mold cavity, and the spacer core disposed within the mold cavity such that the locking member is disposed within the mold cavity at the proximal mold end; At least one plug, the at least one plug being disposed in the at least one locking hole; and An adapter configured to operably connect to the mold body at the distal mold end, the adapter being configured to operably connect the mold body to a bone cement injection device to provide a fluid pathway from the bone cement injection device through the distal mold opening to the mold cavity; and A cap-shaped member configured to be operatively coupled to a distal end of the spacer core, wherein the cap-shaped member includes a distal cap-shaped member opening centrally positioned about the central axis, the cap-shaped member defining a plurality of channels in fluid communication with the distal cap-shaped member opening and extending from the distal cap-shaped member opening toward a proximal cap-shaped member end.

11. The mold assembly of claim 10, wherein the mold body further includes at least one mold hole extending radially through the mold body and the mold cavity relative to the central axis, and wherein the at least one hole plug is configured to be disposed in the at least one mold hole.

12. The mold assembly of claim 11, wherein the at least one mold hole is aligned with the at least one locking hole, and the at least one plug is disposed within both the at least one locking hole and the at least one mold hole.

13. The mold assembly according to any one of claims 10 to 12, further comprising a cutting device having a blade configured to cut the mold body to a desired length measured in a longitudinal direction, wherein the central axis is oriented in the longitudinal direction and the radial direction is perpendicular to the longitudinal direction.

14. The mold assembly of claim 13, wherein the cutting device has a first mounting form configured to receive the mold body and hold the mold body relative to the blade such that the blade is oriented in a transverse direction perpendicular to the longitudinal direction.

15. The mold assembly of claim 13, wherein the cutting device further comprises a second mounting form configured to receive the mold body and hold the mold body relative to the blade such that the blade is oriented in the longitudinal direction, wherein the blade is configured to longitudinally cut the mold body from the proximal mold end to the distal mold end.

16. A kit for forming temporary adhesive spacers, comprising: At least one rod, the at least one rod defining a proximal rod end and a distal rod end opposite to the proximal rod end; A locking member configured to be operably coupled to the rod, the locking member defining a distal locking end and a proximal locking end opposite the distal locking end, the distal locking end being configured to be attached to the rod at the proximal rod end, the locking member further defining at least one locking hole extending through the locking member and configured to receive a locking screw, wherein the at least one rod and the locking member are configured to form a spacer core when operably coupled; At least one hole plug, the at least one hole plug being configured to be removably disposed within the at least one locking hole; A mold body defining a proximal mold end and a distal mold end opposite to the proximal mold end, and an outer mold surface extending from the proximal mold end and the distal mold end, the mold body further defining a proximal mold opening at the proximal mold end and a distal mold opening at the distal mold end, and an inner mold surface extending between the proximal mold opening and the distal mold opening, the inner mold surface defining a mold cavity extending therebetween, wherein the spacer core is configured to be disposed in the mold cavity; An adapter configured to be operably coupled to the mold body at the distal mold end, wherein the adapter is further configured to couple a bone cement injection device to the distal mold opening to provide a fluid passage from the cement injection device to the mold cavity. as well as A cap-shaped member configured to be operatively coupled to the distal end of the rod, wherein the cap-shaped member includes a distal cap-shaped member opening centrally positioned about a central axis, the cap-shaped member defining a plurality of channels in fluid communication with the distal cap-shaped member opening and extending from the distal cap-shaped member opening toward the proximal cap-shaped member end.

17. The kit of claim 16, wherein the at least one rod comprises a plurality of rods, wherein each of the plurality of rods has a length measured between the proximal rod end and the distal rod end, and wherein the length of each rod is different from any other rod length of the plurality of rods.

18. The kit of claim 16 or claim 17 further includes an insertion device configured to be operatively coupled to the proximal locking end of the locking member, wherein the insertion device is configured to implant the temporary adhesive spacer.

19. The kit of claim 16 or claim 17, further comprising a tool having a proximal tool surface having a geometry complementary to the distal cap surface of the cap, the tool defining a plurality of channels recessed from the proximal tool surface, wherein the tool is configured such that the distal cap surface engages with the proximal tool surface in a manner that removes excess adhesive from the cap, wherein the plurality of channels are configured to guide at least some of the excess adhesive away from the cap.

20. A method for preparing an antimicrobial elution temporary adhesive spacer, the method comprising: A spacer core is inserted into the inner cavity of the mold body. The spacer core includes a rod and a locking component connected to the rod, wherein the locking component includes at least one locking hole. The bone cement injection device is connected to the mold body via an adapter to provide a fluid passage from the bone cement injection device to the cavity of the mold body; At least one plug is placed into the at least one locking hole; Bone cementing material comprising one or more antimicrobial agents is injected into the cavity of the mold body through the fluid passage and along at least a portion of the outer rod surface of the rod; The bone adhesive material is cured on the surface of the outer rod to form an adhesive coating on the spacer core, thereby forming the antimicrobial elution temporary adhesive spacer; Disconnect the bone cement injection device from the mold body; Remove the at least one hole plug from the at least one locking hole; and Separate the mold body from the antimicrobial elution temporary adhesive spacer. The method further includes attaching a cap-shaped member to the rod, wherein the cap-shaped member defines a proximal cap-shaped member end and an opposing distal cap-shaped member end, wherein the proximal cap-shaped member end is operatively coupled to a distal end of the rod, wherein the step of injecting bone cement material includes advancing the bone cement material through a plurality of channels extending through the cap-shaped member from the distal cap-shaped member end toward the proximal cap-shaped member end, and The step of injecting bone cement material includes pushing the bone cement material through the distal cap opening, through the plurality of channels and into the mold cavity.

21. The method of claim 20, further comprising: Prior to the step of inserting the spacer core into the mold cavity, the rod is connected to the locking member, wherein the connection step includes operably coupling the proximal end of the rod to the distal end of the locking member.

22. The method of claim 20 or claim 21, wherein the mold body defines a mold length measured from a proximal mold end to an opposite distal mold end, the method comprising removing a portion of the mold body length from the proximal mold end or the distal mold end.

23. The method of claim 20 or claim 21, wherein the mold body defines an outer mold surface extending from a proximal mold end to a distal mold end, and wherein the mold body includes at least one mold hole extending from the outer mold surface through the mold cavity, the method comprising aligning the at least one locking hole with the at least one mold hole, and the step of disposing the at least one hole plug in the at least one locking hole further comprising disposing the at least one hole plug in the at least one mold hole.

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