Taper connection separation device and method

Abstract

An impactor (100) for separation and removal of a tray from a stem of an implant assembly can include a strike plate (106) defining a strike plate outer dimension (D1). The assembly can also include a piston (104) connected to a distal portion of the strike plate, where the piston can define a piston (D2) outer dimension that is smaller than the strike plate outer dimension. The piston can include a groove (114) extending radially inward from an outer surface (116) of the piston. The groove can be located near a distal portion of the piston opposite the strike plate. The assembly can include a seal (118) positionable at least partially within the groove.

Description

TAPER CONNECTION SEPARATION DEVICE AND METHODCLAIM OF PRIORITY

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 619,976, filed on January 11, 2024, the benefit of priority of which is claimed hereby, and which is incorporated by reference herein in its entirety.BACKGROUND

[0002] Implants can be implanted, inserted, or otherwise secured to humans or animals for various purposes. Some implants can be used to replace one or more bones or tissues of a joint that has failed or that no longer provides a full range of motion without pain. For example, in a shoulder that needs to be replaced, the humeral head can be resected, and a replacement head implant can be secured to the humerus and a glenoid implant can be used to replace the glenoid cavity of the scapula. In a reverse shoulder replacement or arthroplasty, a projection can be secured to the scapula and a tray and bearing can be secured to the humerus.BRIEF DESCRIPTION OF THE DRAWINGS

[0003] In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.

[0004] FIG. 1 illustrates an isometric view of an impactor.

[0005] FIG. 2 illustrates an isometric view of an impactor.

[0006] FIG. 3 illustrates an isometric view of an implant assembly.

[0007] FIG. 4 illustrates a cross-sectional view of an implant assembly.

[0008] FIG. 5 illustrates an isometric view of an implant assembly and an impactor.

[0009] FIG. 6 illustrates a cross-sectional view of an implant assembly and an impactor.

[0010] FIG. 7 illustrates a cross-sectional view of an implant assembly and an impactor.

[0011] FIG. 8 illustrates a cross-sectional view of an implant assembly and an impactor.

[0012] FIG. 9 illustrates a cross-sectional view of an implant assembly and an impactor.

[0013] FIG. 10 illustrates a schematic view of a method.

[0014] FIG. 11 illustrates an isometric view of an impactor.

[0015] FIG. 12 illustrates an isometric view of an impactor.

[0016] FIG. 13 illustrates an isometric view of an implant assembly.

[0017] FIG. 14 illustrates an isometric view of an impactor.

[0018] FIG. 15 illustrates a cross-sectional view of an implant assembly.

[0019] FIG. 16 illustrates an enlarged cross-sectional view of an implant assembly.DETAILED DESCRIPTION

[0020] In a reverse shoulder humeral implant assembly, the humeral implant can include a stem that is insertable into an intramedullary canal of a humerus. The assembly can also include a tray that can be secured to the stem. The tray can be configured to receive a bearing for engagement with a glenoid implant. The tray can be secured to the stem via an interference fit such as a taper-to-taper fit (e.g., Morse taper). Such a connection can be relatively difficult to separate when separation is required (such as intraoperatively or during a revision).

[0021] The present disclosure can help to address these issues by including an impactor that uses fluid and hydraulic force(s) to separate the tray from the stem. The impactor can include a shaft or piston insertable into a bore of the tray and a bore of the stem to interact with an incompressible fluid (e.g., water) filling the bores of the stem and tray. The impactor can be struck with a striking tool (e.g., mallet or hammer) to deliver force to the fluid. Because the fluid is incompressible, force can be transferred to the stem or projection of the tray to cause separation from the stem of the implant assembly, allowing the tray to be quickly and easily removed from the stem. Also, because theimpactor can fit into a bore of many implants, the impactor can be used for separation of various implant assemblies, as opposed to requiring specialized tools for each component or implant assembly.

[0022] For example, an impactor for separation and removal of a tray from a stem of an implant assembly can include a handle defining a handle outer dimension. The assembly can also include a strike plate connected to a proximal portion of the handle. The assembly can also include a piston connected to a distal portion of the handle opposite the strike plate, where the piston can define a piston outer dimension that is smaller than the handle outer dimension. The piston can include a groove extending radially inward from an outer surface of the piston. The groove can be located near a distal portion of the piston opposite the handle. The assembly can include a seal positionable at least partially within the groove. The seal can be configured to extend beyond the outer surface of the piston in an uncompressed state and the seal and the piston can together be insertable into a bore of the tray to compress the seal and form a hydraulic seal between the impactor and the tray, the piston configured to deliver an impaction force from the strike plate to a hydraulic fluid within the bore to separate the tray from the stem.

[0023] The above discussion is intended to provide an overview of subject matter of the present patent application. It is not intended to provide an exclusive or exhaustive explanation of the invention. The description below is included to provide further information about the present patent application.

[0024] FIG. 1 illustrates an isometric view of an impactor 100. FIG. 2 illustrates an isometric view of the impactor 100. FIGS. 1 and 2 are discussed together below. FIGS. 1 and 2 also show orientation indicators Proximal and Distal. The impactor 100 can be used to separate components of an implant assembly using hydraulic fluids, as discussed in further detail below. Though the impactor 100 is discussed as being primarily used to separate a tray from a stem of a shoulder arthroplasty implant assembly, the impactor 100 can be used to separate many or various implants that are connected by taper connections or interference connections, such as a tibial tray to stem extension connection for one ormore knee prostheses, or such as a stem to femoral head connection for one or more hip prostheses.

[0025] The impactor 100 can include a handle 102 defining a handle outer dimension DI. The impactor 100 can include a piston 104 connected to a distal portion of the handle 102 where the piston 104 can define an outer dimension D2 that can be smaller than the dimension DI. The impactor 100 can also include a strike plate 106 connected to a proximal portion of the handle 102.

[0026] One or more of the components of the impactor 100 can be rigid or semi-rigid members made of materials such as one or more of metals, plastics, foams, elastomers, ceramics, composites, or the like. The handle 102, the piston 104, or the strike plate 106 can be integrally formed (e.g., machined, cast, or additively manufactured) or can be one or more pieces that are connected (e.g., welded, adhered, or fastened).

[0027] The strike plate 106 can be a plate-like member that can be connected to the handle 102 and can be configured to receive a force (e.g., impact or strike) and transmit the force to the handle 102 and the piston 104. The strike plate 106 can be sized sufficiently to provide a target for striking, but can be sized to be small enough to limit a moment transferred from the strike plate 106 to the handle 102 caused by an off-center strike.

[0028] The handle 102 can be sized and shaped to be grasped and operated. An outer surface of the handle can include scallops, grooves, fluting, serrations, or other surface treatments configured to increase friction between a user’s hand and the handle 102. The piston 104 can be connected to a distal portion of the handle 102 opposite the strike plate 106. The strike plate 106 can be connected to the handle 102 by a radiused surface 108. The handle 102 can be connected to the piston 104 by a radiused surface 110. The radiused surfaces or portions of the impactor 100 can be configured to reduce stress in transfer of forces during impacting. The handle 102 can have a shape of a cylinder but can be or have other shapes in other examples, such as an octagonal prism, hexagonal prism, or the like.

[0029] The piston 104 can be cylindrical in shape such as to mate or be complimentary with a cylindrical bore, but the piston 104 can be other shapes in otherexamples. The piston 104 can include a distal tip 112 that can be rounded or curved. The distal tip 112 can help to guide the piston 104 into a bore of the tray or stem. The distal tip 112 being curved or rounded can help prevent scraping or otherwise damaging the piston 104 or a bore of the tray during use of the impactor 100 to separate the tray from the stem. The piston 104 can also include or can define a groove 114 extending radially inward from an outer surface 116 of the piston 104. The groove 114 can be located near the distal tip 112 (or a distal portion of the piston 104) such as opposite the handle 102. The groove 114 can extend around an entirety of the piston 104.

[0030] The impactor 100 can also include a seal 118 positionable or locatable at least partially within the groove 114. The seal 118 can be a gasket, O-ring, or any other type of seal configured to form a seal between the piston 104 and a bore. The seal 118 can be made of metal, polymer, rubber, or the like. For example, the seal 118 can be a rubber gasket or O-ring. In another example, the groove 114 can be omitted and the seal 118 can be a metallic ring seal (e.g., a piston ring seal). Optionally, the seal 118 can be configured to extend beyond the outer surface 116 of the piston 104 in an uncompressed state. And, the seal 118 can be configured to compress or deform to form a hydraulic seal between the impactor 100 and a tray, as discussed in further detail below.

[0031] As shown in FIG. 2, a distance D3 between the groove 114 (or the seal 118) and the distal tip 112 can be between 1 time and 4 times a diameter (or outer dimension D2) of the piston 104. Optionally, the distance D3 can be about 1.5-2.5 times time the diameter D2. Optionally, the distance D3 can be about 2 times the diameter D2 of the piston 104. The distance D3 can be at a distance sufficient to provide a seal between the groove 114 and the bore 60 while allowing the cavity or bore to be filled or mostly filled with hydraulic fluid (or incompressible fluid). The distance D3 can be at a distance sufficient to allow a user to align the piston 104 along the axis A with the bore 60 before the seal 118 engages the bore 60.

[0032] Optionally, a diameter D4 of the groove 114 can be between 1 millimeter (mm) and 5 mm. Optionally, a diameter D4 of the groove 114 can be between 2.5 mm and 3.5 mm. Optionally, a diameter D4 of the groove 114 can be between 2.9 mm and 3.1 mm. Optionally, a diameter D4 of the groove 114 can be about 3 mm. Optionally, the groove114 can have an axial length of between 0.5 mm and 3 mm. Optionally, the groove 114 can have an axial length of between 1 mm and 2 mm. Optionally, the groove 114 can have an axial length of about 1.35 mm. Optionally, the piston outer dimension D2 can be between 2 mm and 10 mm. Optionally, the outer dimension D2 can be between 4 mm and 6 mm. Optionally, the outer dimension D2 can be between 4.5 mm and 5.5 mm. Optionally, the outer dimension D2 can be about 4.8 mm.

[0033] FIG. 3 illustrates an isometric view of an implant assembly 50. FIG. 4 illustrates a cross-sectional view of the implant assembly 50. FIGS. 3 and 4 are discussed together below. FIGS. 3 and 4 show that the implant assembly 50 can include a tray 52 and a stem 54. The stem 54 can be insertable into an intramedullary canal (e.g., a humeral IM canal). The tray 52 can be secured or connected to the stem 54 through a taper-to- taper connection (e g., a taper friction fit or interference fit) that can be installed using a mallet or impactor to seat or secure the taper connection. A load or force required to unseat the connection is directly proportion to the load or force used to make the connection.

[0034] The tray 52 can include a projection 56 or stem that can be insertable into a bore 58 of the stem 54. The projection 56 and the bore 58 can each be tapered having complementary shapes to form a taper-to-taper connection. The tray 52 can also define a tray bore 60 that can extend at least partially through the projection 56 and that can be coaxial with the bore 58, such as along an axis A.

[0035] FIGS. 3 and 4 show how the tray 52 can be connected to the stem 54 such that the projection 56 is inserted into the bore 58. FIG. 4 also shows that the tray bore 60 and the bore 58 can be filled with fluid FL, which can be an incompressible fluid or liquid, such as water, distilled water, saline, or the like. The fluid can be inserted into the tray bore 60 and the bore 58 to mostly fill the tray bore 60 or to fill the tray bore 60 and the bore 58 to a level higher than an end 62 of the bore 58 and higher than a termination of the projection 56.

[0036] FIG. 5 illustrates an isometric view of the implant assembly 50 and the impactor 100. FIG. 6 illustrates a cross-sectional view of the implant assembly 50 and the impactor 100. FIGS. 5 and 6 are discussed together below. FIGS. 5 and 6 also show theaxis A and the fluid FL. The impactor 100 and the implant assembly 50 can be similar or consistent with the impactor 100 discussed above. FIGS. 5 and 6 show steps of how the impactor 100 can be used.

[0037] For example, FIGS. 5 and 6 show that the tip 112 of the piston 104 can be inserted into the tray bore 60 until the distal tip 112 crosses the fluid line FL within the tray bore 60. Prior to insertion of the distal tip 112 into the tray bore 60, a user can align the piston 104 with the tray bore 60, such as along the axis A. Once the distal tip 112 is inserted, the seal 118 can form a seal between the piston 104 and the tray bore 60 such that fluid cannot escape (or cannot easily escape) between the piston 104 and the tray bore 60, such as during impacting of the impactor 100.

[0038] FIG. 7 illustrates an isometric view of the implant assembly 50 and the impactor 100. FIG. 8 illustrates a cross-sectional view of the implant assembly 50 and the impactor 100. FIGS. 7 and 8 are discussed together below. FIGS. 5 and 6 also show the axis A and the various forces. The impactor 100 and the implant assembly 50 can be similar or consistent with the impactor 100 and implant assembly 50, respectively, discussed above; FIGS. 7 and 8 show steps of how the impactor 100 can be used.

[0039] For example, FIG. 7 shows that a force Fl or a force parallel to the arrow of Fl (such as along the axis A) can be applied to the impactor 100 (e.g., to the strike plate 106). The force Fl can be transmitted from the strike plate 106, to the handle 102, and to the piston 104. The force Fl can then be transferred to transmitted to the fluid FL within the tray bore 60. Because the fluid FL is incompressible, the force Fl can be transferred to the fluid FL and can result in reaction forces created by the fluid and applied in every direction, or increasing a pressure of the fluid FL. This can include a reaction force F2 applied in a direction opposite the force Fl (such as long the axis A). Due to the shape and size of the projection 56, the projection 56 can be exposed to the force F2 via the bore 58. This can allow the force F2 to be applied to the projection 56 and can cause the tray 52 to separate from the stem 54 (e.g., the projection 56 to separate from the bore 58).

[0040] Then, as shown in FIG. 8, following separation of the tray 52 from the stem 54, a force F3 can be applied to the tray 52 to remove the tray 52 from the stem 54. The force F3 can be applied to the tray 52 by a hand instrument, e.g., operated by a user or surgeon.Optionally, the force F3 can be applied by the handle 102 to the tray 52 via the engagement between the tray bore 60 and the seal 118.

[0041] FIG. 9 illustrates a cross-sectional view of an implant assembly 50 and an impactor 900. The implant assembly 50 can be consistent with the implant assembly 50 discussed above. The impactor 900 can be similar to the impactor 100 discussed above in that the impactor 900 can include a handle, a strike plate, and a piston 904. The impactor 900 can include a distal tip that forms a seal between the tray bore 60 and the impactor 900. Any of the impactors discussed above or below can include the features of the impactor 900.

[0042] More specifically, the piston 904 can be made of a material configured to form a seal between the piston 904 and the tray bore 60, such as a polymer, such as Polyphenyl sulfone (PPSU). The polymer (or other material) can be sufficiently rigid to transfer the force from the strike plate to the incompressible fluid, but can be flexible enough such that a seal 918 between a distal tip 912 of the piston 904 and the tray bore 60 can be formed. In some examples, the distal tip 912 can be shaped such that a radially outer portion 920 of the distal tip 912 can be relatively thin and can be configured to elastically deflect or change shapes to conform to the tray bore 60 and to form a seal between the piston 904 and the tray bore 60 to allow the impactor 900 to be used to transfer force(s) to a fluid within the tray bore 60 to separate the tray 52 from the stem 54.

[0043] FIG. 10 illustrates a schematic view of the method 1000, in accordance with at least one example of this disclosure. The method 1000 can be a method of separating a first implant from a second implant (or a first implant component from a second implant component). More specific examples of the method lOOOare discussed below. The steps or operations of the method 1000 are illustrated in a particular order for convenience and clarity; many of the discussed operations can be performed in a different sequence or in parallel without materially impacting other operations. The method 1000, as discussed includes operations performed by multiple different actors, devices, or systems. It is understood that subsets of the operations discussed in the method 1000 can beattributable to a single actor, device, or system could be considered a separate standalone process or method.

[0044] The method 1000 can be a method of separating and removing a tray of an implant assembly from a stem of the implant assembly. However, the steps of the method 1000 can also be used to separate implant assembly components of other implant assemblies, such as a femoral hip arthroplasty implant assembly, a humeral shoulder arthroplasty implant assembly, one or more components of a compress implant assembly, or any other implant assembly including components secured through an interference fit (or an adhesive) and including one or more bores to receive an impactor therein.

[0045] The method 1000 can begin at a step 1002 which can be to fill, at least partially, incompressible fluid into a bore of a first component and a bore of a second component. For example, the fluid FL can be added to the tray bore 60 or the bore 58. During or after filling, the implant can be oriented at least partially vertically to help allow compressible fluids (e.g., air) to escape from the bores (e.g., the bores 58 and 60). Optionally, if orientation of the bores at least partially vertically is not possible, an incompressible fluid with a relatively higher viscosity can be used to help retain the fluid within the bores 58 and 60. At a step 1004, a piston of an impactor can be aligned with one or more bores of the first component or the second component. For example, the piston 104 can be aligned with the tray bore 60 or the bore 58, such as along the axis A.

[0046] At a step 1006, the piston or shaft of the impactor can be inserted at least partially into the bores of the first and second components. For example, the piston 104 can be inserted at least partially into the tray bore 60 and the bore 58. At a step 1008, a seal can be formed between the impactor and a bore of the implant, such as a tray or other implant component. For example, a seal can be formed between the piston 104 and the tray bore 60. Optionally, as part of the step 1008, a gasket can be compressed between the piston and the first component to form the seal between the piston, the first component, and the second component. For example, the seal 118 can be compressed between the piston 104 and the tray bore 60 to form the seal between the piston 104, the tray 52, and the stem 54.

[0047] At step 1010, the components can be separated by impacting a strike plate of the impactor to generate a hydraulic reaction force on the first component and the second component to cause separation therebetween. For example, the tray 52 and the stem 54 can be separated by impacting the strike plate 106 of the impactor 100 to generate a hydraulic reaction force on the tray 52 and the stem 54 to cause separation therebetween. Optionally, as part of the step 1010, force can be transferred from the piston to the incompressible fluid to the first component and the second component to cause separation of the first component from the second component. For example, force can be transferred from the piston 104 to the fluid FL to the tray 52 and the stem 54 to cause separation of the stem 54 from the projection 56.

[0048] FIG. 11 illustrates an isometric view of an impactor 1100. FIG. 12 illustrates an isometric view of the impactor 1100. FIGS. 11 and 12 are discussed together below. FIGS. 11 and 12 also show orientation indicators Proximal and Distal. The impactor 1100 can be similar to the impactor 100 discussed above, such that the impactor 1100 can be used to separate components of an implant assembly using hydraulic fluids. The impactor 1100 can be an impactor that does not include a handle. Any of the impactors discussed above or below can include the features of the impactor 1100.

[0049] The impactor 1100 can include a piston 1104 and a strike plate 1106. The piston 1104 can be connected to a distal portion of the strike plate 1106. The piston 1104 can define an outer dimension D2 and the strike plate 1106 can define a dimension D5 where the dimension D2 can be smaller (e.g., significantly smaller) than the dimension D5, as discussed in further detail below. One or more of the components of the impactor 1100 can be rigid or semi-rigid members made of materials such as one or more of metals, plastics, foams, elastomers, ceramics, composites, or the like. The piston 1104 or the strike plate 1106 can be integrally formed (e.g., machined, cast, or additively manufactured) or can be one or more pieces that are connected (e.g., welded, adhered, or fastened).

[0050] The strike plate 1106 can be a plate-like member that can be connected to the piston 1104 and can be configured to receive a force (e.g., impact or strike) and transmit the force to the piston 1104. The strike plate 1106 can be sized sufficiently to provide atarget for striking, but can be sized to be small enough to limit a moment transferred from the strike plate 1106 to the piston 1104 caused by an off-center strike. Also, because the impactor 1100 does not include a handle, and because the piston 1104 can be used to properly align and position the impactor 1100 within a bore of an implant assembly, the impactor 1100 can help to reduce or eliminate off-center strikes that can occur when a physician holds a handle in such a way where the piston is not axially aligned with the bore.

[0051] The piston 1104 can be cylindrical in shape such as to mate or be complimentary with a cylindrical bore, but the piston 1104 can be other shapes in other examples. The piston 1104 can include a distal tip 1112 that can be rounded or curved. The distal tip 1112 can help to guide the piston 1104 into a bore of the tray or stem. The distal tip 1112 being curved or rounded can help limit scraping or otherwise damaging the piston 1104 or a bore of the tray during use of the impactor 1100 to separate the tray from the stem.

[0052] The piston 1104 can also include or can define a groove 1114 extending radially inward from an outer surface 1116 of the piston 1104. The groove 1114 can be located near the distal tip 1112 (or a distal portion of the piston 1104) such as opposite the strike plate 1106. The groove 1114 can extend around an entirety of the piston 1104. The impactor 1100 can also include a seal 1118 positionable or locatable at least partially within the groove 1114. The seal 1118 can be a gasket, O-ring, or any other type of seal configured to form a seal between the piston 1104 and a bore. The seal 1118 can be made of metal, polymer, rubber, or the like. For example, the seal 1118 can be a rubber gasket or O-ring. In another example, the groove 1114 can be omitted and the seal 1118 can be a metallic ring seal (e.g., a piston ring seal). Optionally, the seal 1118 can be configured to extend beyond the outer surface 1116 of the piston 1104 in an uncompressed state. And, the seal 1118 can be configured to compress or deform to form a hydraulic seal between the impactor 1100 and a tray, as discussed in further detail below.

[0053] The strike plate 1106 can be connected to the piston 1104 by a radiused surface 1108, which can help to transmit a force from the strike plate 1106 to the piston 1104 without cracking or fracturing of the impactor 1100. The strike plate 1106 can alsoinclude a proximal surface 1122 (shown in FIG. 12). The proximal surface 1 122 can be curved or shaped such that the proximal surface 1122 is convex or rounded towards the distal end of the strike plate 1106 as the strike plate 1106 extends radially outward. The convex shape of the strike plate 1106 can help to direct force toward the piston 1104 (e g., along the axis A) during off-center strikes applied to the strike plate 1106.

[0054] The proximal surface 1122 of the strike plate 1106 can also be connected to the radiused surface 1108 by a radially outer surface 1124 of the strike plate 1106. The radially outer surface 1124 can be curved, radiused, rounded or the like, which can help to reduce sharp edges or comers to help reduce damage caused by engagement between the radially outer surface 1124 and any nearby tissue or component during placement, removal, or striking operations.

[0055] As shown in FIG. 12, the distance D3 between the groove 1114 (or the seal 1118) and the distal tip 1112 can be between 1 time and 10 times a diameter (or outer dimension D2) of the piston 1104, such as between 2 times and 8 times the diameter of the piston 104, or such as between 3 times and 6 times the diameter of the piston 1104. Optionally, the distance D3 can be about 3 times the diameter D2 of the piston 1104. The distance D3 can be a distance sufficient to provide a seal between the groove 1114 and the bore 60 while allowing the cavity or bore to be filled or mostly filled with hydraulic fluid (or incompressible fluid). The distance D3 can be at a distance sufficient to allow a user to align the piston 1104 along an axis of the bore 60 before the seal 1118 engages the bore 60. Optionally, a diameter of the groove 1114 can be similar to that of the groove 114 discussed above. Similarly, an outer dimension of the piston 1104 can be similar to that of the piston 104. The dimension D3 between the groove 1114 (or the seal 1118) and the distal tip 1112 can also help to hold the piston 1104 in a proper orientation for striking without the need to hold the impactor 1100 during striking.

[0056] FIG. 13 illustrates an isometric view of an implant assembly 50, which can include a tray 52 and a stem 54. FIG. 13 also shows orientation indicators Proximal and Distal. The implant assembly 50 can be similar to the implant assembly 50 discussed above. FIG. 13 shows how the piston 1104 of the impactor 1100 can be insertable into the tray bore 60 such that when the bore 58 is filled with fluid, the strike plate 1106 can bestruck with a striking device to separate the tray 52 from the stem 54. Because the impactor 1100 does not include a handle, and because the piston 1104 can be used to properly align and position the impactor 1100 within the tray bore 60, the impactor 1100 can help to reduce or eliminate off-center strikes that from occurring.

[0057] FIG. 14 illustrates an isometric view of an impactor 1400. FIG. 14 also shows orientation indicators Proximal and Distal. The impactor 1400 can be similar to the impactors 100 or 1400 discussed above, such that the impactor 1400 can be used to separate components of an implant assembly using hydraulic fluids, as discussed in further detail below. The impactor 1400 can be an impactor that includes integral projections. Any of the impactors discussed above or below can include the features of the impactor 1100.

[0058] The impactor 1400 can include a handle 1402 defining a handle outer dimension DI. The impactor 1400 can include a piston 1404 connected to a distal portion of the handle 102 where the piston 1404 can define an outer dimension D2 that can be smaller than the dimension DI. The impactor 1400 can also include a strike plate 1406 connected to a proximal portion of the handle 1402.

[0059] One or more of the components of the impactor 1400 can be rigid or semi-rigid members made of materials such as one or more of metals, plastics, foams, elastomers, ceramics, composites, or the like. The handle 1402, the piston 1404, or the strike plate 1406 can be integrally formed (e.g., machined, cast, or additively manufactured) or can be one or more pieces that are connected (e.g., welded, adhered, or fastened).

[0060] The strike plate 1406 can be connected to the handle 1402 at a proximal portion thereof and can be configured to receive a force (e.g., impact or strike) and transmit the force to the handle 1402 and the piston 1404. The strike plate 1406 can be sized sufficiently to provide a target for striking, but can be sized to be slightly smaller than the handle 1402 such as to limit a moment transferred from the strike plate 1406 to the handle 1402 caused by an off-center strike.

[0061] The handle 1402 can be sized and shaped to be grasped and operated. The handle 1402 can have a shape of a cylinder but can be or have other shapes in other examples, such as an octagonal prism, hexagonal prism, or the like. An outer surface ofthe handle can include scallops, grooves, fluting, serrations, or other surface treatments configured to increase friction between a user’s hand and the handle 1402.

[0062] A collar 1407 can be connected to a distal end or distal portion of the handle 1402 and a proximal end or portion of the piston 1404 opposite the strike plate 1406. The collar 1407 can have a dimension D6 that is larger than the dimension DI of the handle. The collar 1407 can be connected to the piston 1404 by a radiused surface 1410. The radiused surfaces or portions of the impactor 100 can be configured to reduce stress in transfer of forces during impacting. Because the collar 1407 can be relatively wider (e.g., the dimension D6 is larger than the dimension DI), the radiused surface 1410 can be a more gradual transition to the piston 1404, which is a much smaller diameter or size D2 than DI, as the size DI is optimized or designed for grasping while the size D2 is made to fit within an implant bore. This can help to further reduce stress between the handle 1402 and the piston 1404 during impacting. The collar 1407 also provides an indexing location for support hand placement to help avoid striking of the support hand during impacting operations.

[0063] The piston 1404 can be cylindrical in shape such as to mate or be complimentary with a cylindrical bore, but the piston 1404 can be other shapes in other examples. The piston 1404 can include a distal tip 1412 that can be rounded or curved. The distal tip 1412 can help to guide the piston 1404 into a bore of the tray or stem. The distal tip 1412 being curved or rounded can help prevent scraping or otherwise damaging the piston 1404 or a bore of the tray during use of the impactor 1400 to separate the tray from the stem.

[0064] The piston 1404 can also include or can define projections 1426 and 1428 that can extend radially outward from an outer surface 1416 of the piston 1404. The projections 1426 and 1428 can have an outer size or diameter that is slightly larger than the dimension D2 of the piston 1404. For example, the outer dimension or diameter of the projections 1426 and 1428 can be 0.1 mm larger than the size D2. The difference in size or dimension can be 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8. 0.9, 1 mm, or the like. The difference can also be 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.08, 0.09 mm, or the like. The difference can fall in a range such as between 0.01 mm and 0.2 mm. In some examples, the rangecan be between 0.025mm and 0.102 mm. The projections 1426 1428 can also be located close to each other, such as to help form a seal between the piston 1404 and the surrounding bore (e.g., the tray bore 60). Though FIG. 14 shows two of the projections 1426 and 1428, the piston 1404 can include 1 projection or 3, 4, 5, 6, 7, 8, 9, 10, or the like. The quantity and size of the projections relative to the dimension D2 and the size of the bore (e.g., the tray bore 60) can be optimized for a hydraulic seal that is still able to be manually released following separation of the tray from the stem.

[0065] FIG. 15 illustrates a cross-sectional view of the implant assembly 50 and the impactor 1400. FIG. 16 illustrates an enlarged cross-sectional view of the implant assembly 50 and the impactor 1400. FIGS. 15 and 16 are discussed together below. FIG. 14 also shows orientation indicators Proximal and Distal. The implant assembly 50 can be similar to the implant assembly 50 discussed above. FIG. 15 shows how the piston 1404 of the impactor 1400 can be insertable into the tray bore 60 such that when the bore 58 is filled with fluid, the strike plate 1106 can be struck with a striking device to separate the tray 52 from the stem 54. The projections 1426 and 1428 of the piston 1404 can form a seal between the tray bore 60 and the piston 1404.

[0066] As shown more clearly in FIG. 16, the projections 1426 and 1428 can extend just radially beyond the outer surface 1416 of the piston 1404 allowing the projections 1426 and 1428 to form an interference fit or seal between the piston 1404 and the tray bore 60 to allow hydraulic forces to be used to separate the tray 52 from the stem 54, as discussed above. Because the projections 1426 and 1428 are integral to the impactor 1400, no disassembly is required before the impactor 1400 is cleaned or sterilized. Also, the projections 1426 and 1428 can increase a strength of the piston 1404 and can be relatively easier (or have a lower cost) to manufature.NOTES AND EXAMPLES

[0067] The following, non-limiting examples, detail certain aspects of the present subject matter to solve the challenges and provide the benefits discussed herein, among others.

[0068] Example 1 is an impactor for separation and removal of a tray from a stem of an implant assembly, the impactor comprising: a strike plate defining a strike plate outer dimension; a piston connected to a distal portion of the strike plate, the piston defining a piston outer dimension that is smaller than the strike plate outer dimension, the piston including a groove extending radially inward from an outer surface of the piston, the groove located near a distal portion of the piston opposite the strike plate; and a seal positionable at least partially within the groove, the seal configured to extend beyond the outer surface of the piston in an uncompressed state, and the seal and the piston together insertable into a bore of the tray to compress the seal and form a hydraulic seal between the impactor and the tray, the piston configured to deliver an impaction force from the strike plate to a hydraulic fluid within the bore to separate the tray from the stem.

[0069] In Example 2, the subject matter of Example 1 optionally includes wherein the strike plate is connected to the piston by a radiused surface.

[0070] In Example 3, the subject matter of any one or more of Examples 1-2 optionally include wherein the distal portion includes a distal tip that is rounded or chamfered.

[0071] In Example 4, the subject matter of Example 4 optionally includes wherein a distance between the groove and the distal tip is between three times the piston outer dimension and 6 times the piston outer dimension.

[0072] In Example 5, the subject matter of Example 4 optionally includes wherein a diameter of the groove is between 2.5 millimeters and 3.5 millimeters and wherein the piston outer dimension is between 4 millimeters and 6 millimeters.

[0073] In Example 6, the subject matter of any one or more of Examples 4-5 optionally include wherein the piston outer dimension is between 4.5 millimeters and 5.5 millimeters..

[0074] In Example 7, the subject matter of any one or more of Examples 1-6 optionally include wherein a proximal surface of the strike plate is convex.

[0075] In Example 8, the subject matter of Example 7 optionally includes wherein the distal portion includes a distal tip that is rounded.

[0076] In Example 9, the subject matter of Example 8 optionally includes wherein the piston has a cylindrical shape.

[0077] In Example 10, the subject matter of Example 9 optionally includes wherein the strike plate is connected to the piston by a radiused surface.

[0078] In Example 11, the subject matter of any one or more of Examples 7-10 optionally include wherein a radially outer surface of the strike plate is curved or radiused.

[0079] In Example 12, the subject matter of any one or more of Examples 1-11 optionally include wherein the seal is annular.

[0080] In Example 13, the subject matter of Example 12 optionally includes wherein the seal is an O-ring.

[0081] Example 14 is a method of separating and removing a tray of an implant assembly from a stem of the implant assembly, the method comprising: filling, at least partially, incompressible fluid into a tray bore of the tray and a stem bore of the stem; inserting a piston of an impactor at least partially into the tray bore and the stem bore; forming a seal between the impactor, the tray bore, and the stem bore; and separating the tray from the stem by impacting a strike plate of the impactor to generate a hydraulic reaction force on the stem and the tray to cause separation therebetween.

[0082] In Example 15, the subject matter of Example 14 optionally includes aligning, axially, the piston with the tray bore.

[0083] In Example 16, the subject matter of any one or more of Examples 14-15 optionally include compressing a gasket between the piston and the tray bore to form the seal between the piston, the tray bore, and the stem bore.

[0084] In Example 17, the subject matter of Example 16 optionally includes wherein the seal is at least partially located within a groove in an outer surface of the piston of the impactor.

[0085] In Example 18, the subject matter of Example 17 optionally includes wherein a diameter of the groove is between 2.5 millimeters and 3.5 millimeters and wherein a piston outer dimension is between 4 millimeters and 6 millimeters.

[0086] In Example 19, the subject matter of any one or more of Examples 14-18 optionally include transferring force from the piston to the incompressible fluid to the stem and the tray to cause separation of the tray from the stem.

[0087] In Example 20, the subject matter of any one or more of Examples 14-19 optionally include removing the tray from the stem using the piston of the impactor.

[0088] Example 21 is an impactor for separation and removal of a tray from a stem of an implant assembly, the impactor comprising: a handle defining a handle outer dimension; a strike plate connected to a proximal portion of the handle; a piston connected to a distal portion of the handle opposite the strike plate, the piston defining a piston outer dimension that is smaller than the handle outer dimension, the piston including a groove extending radially inward from an outer surface of the piston, the groove located near a distal portion of the piston opposite the handle; and a seal positionable at least partially within the groove, the seal configured to extend beyond the outer surface of the piston in an uncompressed state, and the seal and the piston together insertable into a bore of the tray to compress the seal and form a hydraulic seal between the impactor and the tray, the piston configured to deliver an impaction force from the strike plate to a hydraulic fluid within the bore to separate the tray from the stem.

[0089] In Example 22, the subject matter of Example 21 optionally includes wherein the strike plate is connected to the handle by a radiused surface.

[0090] In Example 23, the subject matter of any one or more of Examples 21-22 optionally include wherein the handle is connected to the piston by a radiused surface.

[0091] In Example 24, the subject matter of any one or more of Examples 21-23 optionally include wherein the distal portion includes a distal tip that is rounded or chamfered.

[0092] In Example 25, the subject matter of Example 24 optionally includes wherein a distance between the groove and the distal tip is two times the piston outer dimension.

[0093] In Example 26, the subject matter of any one or more of Examples 24-25 optionally include wherein an outer surface of the handle is scalloped or fluted.

[0094] In Example 27, the subject matter of any one or more of Examples 24-26 optionally include wherein a diameter of the groove is between 2.5 millimeters and 3.5millimeters and wherein the piston outer dimension is between 4 millimeters and 6 millimeters.

[0095] In Example 28, the subject matter of any one or more of Examples 24-27 optionally include wherein the piston outer dimension is between 4.5 millimeters and 5.5 millimeters.

[0096] Example 29 is an impactor for separation and removal of a first component of an implant assembly from a second component of an implant assembly, the impactor comprising: a handle defining a handle outer dimension; a strike plate connected to a proximal portion of the handle; a piston connected to a distal portion of the handle opposite the strike plate, the piston defining a piston outer dimension that is smaller than the handle outer dimension, the piston including a groove extending radially inward from an outer surface of the piston, the groove located near a distal portion of the piston opposite the handle; and a seal positionable at least partially within the groove, the seal configured to extend beyond the outer surface of the piston in an uncompressed state, and the seal and the piston together insertable into a bore of the first component to compress the seal and form a hydraulic seal between the impactor and the first component, the piston configured to deliver an impaction force from the strike plate to a hydraulic fluid within the bore to separate the first component from the second component.

[0097] In Example 30, the subject matter of Example 29 optionally includes wherein the distal portion includes a distal tip that is rounded.

[0098] In Example 31, the subject matter of Example 30 optionally includes wherein a distance between the groove and the distal tip is two times the piston outer dimension.

[0099] In Example 32, the subject matter of Example 31 optionally includes wherein an outer surface of the handle is scalloped or fluted.

[0100] In Example 33, the subject matter of Example 32 optionally includes wherein a diameter of the groove is between 2.5 millimeters and 3.5 millimeters and wherein the piston outer dimension is between 4 millimeters and 6 millimeters.

[0101] In Example 34, the apparatuses or method of any one or any combination of Examples 1 - 33 can optionally be configured such that all elements or options recited are available to use or select from.

[0102] The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” Such examples can include elements in addition to those shown or described. However, the present inventors also contemplate examples in which only those elements shown or described are provided. Moreover, the present inventors also contemplate examples using any combination or permutation of those elements shown or described (or one or more aspects thereof), either with respect to a particular example (or one or more aspects thereof), or with respect to other examples (or one or more aspects thereof) shown or described herein.

[0103] In the event of inconsistent usages between this document and any documents so incorporated by reference, the usage in this document controls. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim.

[0104] In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In this document, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, composition, formulation, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.

[0105] The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. § 1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description as examples or embodiments, with each claim standing on its own as a separate embodiment, and it is contemplated that such embodiments can be combined with each other in various combinations or permutations. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.

Claims

CLAIMS:

1. An impactor for separation and removal of a tray from a stem of an implant assembly, the impactor comprising: a strike plate defining a strike plate outer dimension; a piston connected to a distal portion of the strike plate, the piston defining a piston outer dimension that is smaller than the strike plate outer dimension, the piston including a groove extending radially inward from an outer surface of the piston, the groove located near a distal portion of the piston opposite the strike plate; and a seal positionable at least partially within the groove, the seal configured to extend beyond the outer surface of the piston in an uncompressed state, and the seal and the piston together insertable into a bore of the tray to compress the seal and form a hydraulic seal between the impactor and the tray, the piston configured to deliver an impaction force from the strike plate to a hydraulic fluid within the bore to separate the tray from the stem.

2. The impactor of claim 1, wherein the strike plate is connected to the piston by a radiused surface.

3. The impactor of claim 1, wherein the distal portion includes a distal tip that is rounded or chamfered.

4. The impactor of claim 3, wherein a distance between the groove and the distal tip is between three times the piston outer dimension and 6 times the piston outer dimension.

5. The impactor of claim 4, wherein a diameter of the groove is between 2.5 millimeters and 3.5 millimeters and wherein the piston outer dimension is between 4 millimeters and 6 millimeters.

6. The impactor of claim 4, wherein the piston outer dimension is between 4.5 millimeters and 5.5 millimeters.

7. The impactor of claim 1, wherein a proximal surface of the strike plate is convex.

8. The impactor of claim 7, wherein the distal portion includes a distal tip that is rounded.

9. The impactor of claim 8, wherein the piston has a cylindrical shape.

10. The impactor of claim 9, wherein the strike plate is connected to the piston by a radiused surface.

11. The impactor of claim 7, wherein a radially outer surface of the strike plate is curved or radiused.

12. The impactor of claim 1, wherein the seal is annular.

13. The impactor of claim 12, wherein the seal is an O-ring.

14. A method of separating and removing a tray of an implant assembly from a stem of the implant assembly, the method comprising: filling, at least partially, incompressible fluid into a tray bore of the tray and a stem bore of the stem; inserting a piston of an impactor at least partially into the tray bore and the stem bore; forming a seal between the impactor, the tray bore, and the stem bore; andseparating the tray from the stem by impacting a strike plate of the impactor to generate a hydraulic reaction force on the stem and the tray to cause separation therebetween.

15. The method of claim 14, comprising: aligning, axially, the piston with the tray bore.

16. The method of claim 14, comprising: compressing a gasket between the piston and the tray bore to form the seal between the piston, the tray bore, and the stem bore.

17. The method of claim 16, wherein the seal is at least partially located within a groove in an outer surface of the piston of the impactor.

18. The method of claim 17, wherein a diameter of the groove is between 2.5 millimeters and 3.5 millimeters and wherein a piston outer dimension is between 4 millimeters and 6 millimeters.

19. The method of claim 14, comprising: transferring force from the piston to the incompressible fluid to the stem and the tray to cause separation of the tray from the stem.

20. The method of claim 14, comprising: removing the tray from the stem using the piston of the impactor.

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