Reusable and customizable instruments for artificial shoulder joint replacement

Abstract

Systems and methods for a customized reusable guide for artificial shoulder joint replacement. In an exemplary embodiment, the method includes providing an alignment compass base configured to allow a rotational orientation of a radius offset insert and a K-wire guide tube relative to a guide base, inserting a guide base component into the alignment compass base, inserting the radius offset insert into the guide base component, using a first alignment tool to rotate the radius offset insert to a first orientation angle relative to the guide base component, inserting the K-wire guide tube into the radius offset insert, and using a second alignment tool to rotate the K-wire guide tube to a second orientation angle relative to the guide base component.

Description

Technical Field

[0001] (Priority) This application claims priority from U.S. Provisional Patent Application No. 63 / 369,678, filed on July 8, 2022, the content of which is hereby incorporated by reference in its entirety. Any and all applications in which claims of foreign or domestic priority are identified in the application data sheet filed with this application are hereby incorporated by reference in this specification under 37 CFR 1.57 of the United States Patent Rules.

Background Art

[0002] Total shoulder arthroplasty is a commonly performed medical treatment for various conditions. During the treatment, a reamer is typically used to prepare the surface of the glenoid fossa to receive a shoulder implant. Prior to reaming, a guide pin or wire, often referred to as a "K-wire," is first inserted into the glenoid fossa. The K-wire is positioned at a predetermined location and angular orientation to ensure proper preparation of the glenoid fossa surface. The reamer is advanced over the K-wire so that the reamer prepares the glenoid fossa surface at the appropriate location and angular orientation. The appropriate location and angular orientation of the K-wire can be determined in advance using surgical planning software. Surgical planning software can enable the custom manufacturing of a surgical guide that is positioned relative to the glenoid fossa to assist in accurately positioning the K-wire. However, it can take several hours to several days to fabricate a customized surgical guide, and it needs to be individually sterilized and stored prior to surgery. This makes it impossible to adjust the guide immediately before surgery. In addition, once fabricated in this way (e.g., by a 3D printer), the customized components cannot be modified and are thus discarded after use. This results in additional costs for clinicians and patients.

[0003] There is a need for a guide that allows the placement and orientation of artificial organs to be customized, thereby enabling a healthcare provider to assemble a guide in which the placement and orientation of the K-wires are customized for the patient and, if necessary, to quickly adjust the size immediately before or during the surgery.

Summary of the Invention

Means for Solving the Problems

[0004] Various embodiments described herein relate to systems, devices, and methods for enabling rotation of a radius offset insert and a K-wire guide tube relative to a guide base. In some embodiments, the method comprises providing an alignment compass base configured to enable rotational orientation of a radius offset insert and a K-wire guide tube relative to a guide base, inserting a guide base component into the alignment compass base, inserting a radius offset insert into the guide base component, using a first alignment tool to rotate the radius offset insert to a first orientation angle relative to the guide base component, inserting a K-wire guide tube into the radius offset insert, and using a second alignment tool to rotate the K-wire guide tube to a second orientation angle relative to the guide base component.

[0005] In some embodiments, the guide base component includes an opening configured to receive a key, and the step of inserting the radius offset insert into the guide base component includes expanding the opening by rotating the key.

[0006] In some embodiments, the step of rotating the radius offset insert to the first orientation angle further includes contracting the opening by rotating the key of the opening.

[0007] In some embodiments, the radial offset insert includes an opening configured to receive a key, and the step of inserting the K-wire guide tube into the radial offset insert includes expanding the opening by rotating the key of the opening.

[0008] In some embodiments, the step of rotating the radial offset insert to a first orientation angle further includes contracting the opening by rotating the key of the opening.

[0009] In some embodiments, the first alignment tool is a disk or plate.

[0010] In some embodiments, the first alignment tool includes an opening shaped to receive the perimeter of a portion of the radial offset insert and is configured to contact the side surface of the radial offset insert when rotated. In some embodiments, the second alignment tool is a disk or plate.

[0011] In some embodiments, the second alignment tool includes an opening shaped to receive the outer peripheral portion of the K-wire guide tube and is configured to contact the side surface of the radial offset insert when rotated.

[0012] In some embodiments, the method further includes rotating the first alignment tool and the second alignment tool relative to the alignment compass base.

[0013] In some embodiments, a customizable prosthetic shoulder replacement instrument device includes an alignment compass base configured to allow rotational orientation of a radius offset insert and a K-wire guide tube relative to a guide base, a guide base component configured to be inserted into the alignment compass base, a radius offset insert configured to be inserted into the guide base component and rotatable to a first orientation angle relative to the guide base component using a first alignment tool, and a K-wire guide tube configured to be inserted into the radius offset insert and rotatable to a second orientation angle relative to the guide base component using a second alignment tool.

[0014] In some embodiments, the guide base component includes an opening configured to receive a key, and the radius offset insert can be adapted to the guide base component by expanding the opening by rotating the key.

[0015] In some embodiments, the radius offset insert can be adapted to the guide base component by contracting the opening by rotating the key of the opening.

[0016] In some embodiments, the radius offset insert includes an opening configured to receive a key, and the step of inserting the K-wire guide tube into the radius offset insert includes the step of expanding the opening by rotating the key of the opening.

[0017] In some embodiments, the step of rotating the radius offset insert to the first orientation angle further includes the step of contracting the opening by rotating the key of the opening.

[0018] In some embodiments, the first alignment tool is a disk or plate.

[0019] In some embodiments, the first alignment tool includes an opening shaped to receive an outer peripheral portion of the radius offset insert and is configured to contact a side surface of the radius offset insert when rotating.

[0020] In some embodiments, the second alignment tool is a disk or plate.

[0021] In some embodiments, the second alignment tool includes an opening shaped to receive an outer peripheral portion of the K-wire guide tube and is configured to contact a side surface of the radius offset insert when rotating.

[0022] In some embodiments, the first alignment tool and the second alignment tool rotate relative to an alignment compass base.

[0023] In some embodiments, a customizable instrument kit for total shoulder arthroplasty comprises an alignment compass base configured to enable rotational orientation of one radius offset insert and one K-wire guide tube relative to one guide base, and one guide base component of a plurality of guide base components configured to be inserted into the alignment compass base, the plurality of guide base components including guide base components of different sizes, One of a plurality of radius offset inserts configured to fit a guide base component, the plurality of radius offset inserts including radius offset inserts of different sizes, the one radius offset insert being rotatable to a first orientation angle with respect to a guide base component using a first alignment tool; and one of a plurality of K-wire guide tubes configured to fit the one radius offset insert, the plurality of K-wire guide tubes including K-wire guide tubes of different sizes, the plurality of K-wire guide tubes being rotatable to a second orientation angle with respect to a guide base component using a second alignment tool. Including.

[0024] In some embodiments, one guide base component includes an opening configured to receive a key, and inserting one radius offset insert into one guide base component includes expanding the opening by rotating the key.

[0025] In some embodiments, one radius offset insert can be inserted into one guide base component by contracting the opening by rotating the key of the opening.

[0026] In some embodiments, one radius offset insert includes an opening configured to receive a key, and inserting one K-wire guide tube into one radius offset insert includes expanding the opening by rotating the key of the opening.

[0027] In some embodiments, rotating one radius offset insert to a first orientation angle further includes contracting the opening by rotating the key of the opening.

[0028] In some embodiments, the first alignment tool is a disk or plate.

[0029] In some embodiments, the first alignment tool includes an opening shaped to receive an outer peripheral portion of one radius offset insert and is configured to contact a side surface of one radius offset insert when rotating.

[0030] In some embodiments, the second alignment tool is a disk or plate.

[0031] In some embodiments, the second alignment tool includes an opening shaped to receive an outer peripheral portion of one K-wire guide tube and is configured to contact a side surface of one radius offset insert when rotating.

[0032] In some embodiments, the first alignment tool and the second alignment tool rotate relative to an alignment compass base.

[0033] Here, various features will be described with reference to the following drawings. Throughout the drawings, reference numerals may be reused to indicate the correlation between the referenced elements. The drawings are provided to illustrate the examples described herein and are not intended to limit the scope of the present disclosure.

Brief Description of the Drawings

[0034]

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DETAILED DESCRIPTION OF THE INVENTION

[0035] An embodiment of the user interface of the shoulder implant surgical planning system 100 is illustrated in FIG. 1. The shoulder implant planning system 100 is configured to receive an image of a patient's glenoid fossa, generate a three-dimensional virtual model 105 of the glenoid fossa 110, and enable a clinician to select a suitable shoulder implant 115 and simulate the placement, orientation, and implantation of the shoulder implant system 115 within the virtual model 105 of the glenoid fossa 110. The image may include a computerized tomography (CT) scan, X-rays, or multiple slices or images from other imaging systems.

[0036] During the surgical planning and simulation phase, the clinician selects the desired implant 115 and positions it at the desired location within the virtual model 105 of the glenoid fossa 110. The shoulder implant planning system 100 then determines the appropriate implant instruments, instrument orientation components, and parameters 120 that will be used by the clinician during the actual surgery to achieve the simulated implant implantation performed using the shoulder implant planning system 100.

[0037] For example, with a shoulder implant planning system 100, the position of the center of an implant pin (or center post or peg) is determined within two dimensions (e.g., vertical and anteroposterior). Also, the angular orientation of the implant pin relative to the glenoid surface is determined by this system. This angular orientation is also determined within two dimensions (e.g., rotation and tilt). Using this calculated center position and angular orientation of the pin, appropriate instrument components are identified and selected, and the orientation of each instrument component relative to one another during use is determined.

[0038] In the embodiment illustrated in FIG. 1, it has been determined that the shoulder implant planning system 100 should use a large-sized tripod component (which may also be referred to as a base component or guide base component), and a radius offset component having a 2.5 mm offset (which may also be referred to as a radius offset bushing or radius offset insert), and a K-wire guide tube having a 15-degree angle (which may also be referred to as a K-wire guide tube insert). Also, it has been determined that the radius component should be oriented at 75 degrees relative to the tripod component, and the K-wire guide tube should be oriented at an angle of 120 degrees relative to the tripod component. The identification of these components and the orientation angles are used by the user to quickly assemble a K-wire guiding instrument, as will be described in more detail below.

[0039] FIG. 2 illustrates one embodiment of a set or kit of instrument components 200 configured to be used with the shoulder implant planning system 100 of FIG. 1. In some embodiments, the instrument components 200 include a guide base component 205, a radius offset insert 210, and a K-wire guide tube insert 215. The guide base component 205 may be provided in the form of a tripod having three pointed legs 220, 222, 224 for placement in the patient's glenoid fossa to establish a reference plane relative to the glenoid fossa surface. The guide base component 205 may be available in different sizes (e.g., small, medium, large, extra-large) and is generally selected by the shoulder implant planning system based on the size of the patient's glenoid fossa groove.

[0040] Figure 3 illustrates guide base components 205 of different sizes. In some embodiments, the guide base component 205 may include one pin-shaped leg 220 disposed on the upper surface of the guide base component 205 and two pin-shaped legs 222, 224 disposed on the lower surface of the guide base component 205. In some embodiments, the guide base component 205 may generally have an annular or circular shape and may include a circular opening 226 that extends along its central axis through its thickness. In some embodiments, the two lower legs 222, 224 may be spaced apart based on the size of the guide base component. In one embodiment, as shown in FIG. 3, the lower legs 222, 224 of the small base are 13.4 mm apart, the lower legs 222, 224 of the medium base are 15.7 mm apart, the lower legs 222, 224 of the large base 205 are 17.5 mm apart, and the legs 222, 224 of the extra-large base are 19.8 mm apart. The distance from the upper leg 110 of the base 205 to the imaginary line extending between the tips that contact the sockets of the two lower legs 222, 224 can likewise be varied based on the size of the guide base component. In one embodiment, as shown in FIG. 3, this distance is 23.6 mm, 26.8 mm, 29.8 mm, or 32.8 mm for small, medium, large, and extra-large guide base components, respectively. Also, the guide base component may include a locking mechanism (not shown), such as a screw and slot wall, that causes the circular opening 226 to contract as two portions of the guide base component 205 move closer together, compressing the radius offset insert 210 and the K-wire guide tube insert 215 (not shown in FIG. 3) when inserted into the opening 226, thereby locking them in place and preventing further movement.

[0041] Figures 4 to 10 illustrate further embodiments of the guide base component 205. For example, FIG. 4 illustrates a guide base component 205 with a key-operated locking mechanism. As shown in FIG. 4, the guide base component 205 may include a support 230 having a circular opening 226 and pointed legs 220, 222, 224. The key-operated locking mechanism may be implemented as a base slot 402 and a base notch 404, or in some cases, only the base slot 402 may be implemented.

[0042] In some embodiments, a key (not shown) may be used to expand the diameter of the circular opening 226 so that a radius offset insert (e.g., the radius offset insert 210 of FIG. 11) can be received. In some embodiments, the key has a rectangular cross-sectional shape such that at its end, it is small enough to fit inside the slot 402 at its narrow dimension and large enough at its wider dimension to push the walls of the slot 402 apart to expand the diameter of the opening 226. The notch 404 provides additional flexibility to the support 230 and helps facilitate the expansion of the diameter of the opening 226. The key may be inserted into and rotated in the slot 402 so that the circular opening 226 expands to accommodate the radius offset insert 210 ("open configuration"). In some embodiments, after the radius offset insert 210 is placed, the key is removed from the base slot 402 to compress the circular opening 226 and compress the radius offset insert 210 when inserted into the opening 226, thereby locking the radius offset insert 210 in place and preventing the radius offset insert 210 from rotating further relative to the base 205.

[0043] Figures 5 - 10 illustrate additional views of the guide base component 205 having the key lock mechanism described above with respect to Figure 4. Figure 5 illustrates a top view or bird's eye view of the guide base component 205. Figure 6 illustrates a bottom view of the guide base component 205. Figures 7 and 8 illustrate side views of the guide base component 205. Figures 9 and 10 illustrate further side views of the guide base component 205.

[0044] Referring again to Figure 2, the radius offset insert 210 is disposed within the circular opening 226 of the guide base component 205 and is configured to rotate to a desired orientation. The radius offset insert 210 includes an offset plate 232 and a circular guide portion 234. The circular guide portion 234 includes a cylindrical cavity 236 configured to receive a corresponding portion 240 of the K - wire guide tube insert 215. The circular guide portion 234 has a circular outer dimension 238 configured to be disposed within the circular opening 226 of the guide base component 205. The central longitudinal axis of the cylindrical cavity 236 is offset by a predetermined distance from the central longitudinal axis of the circular guide portion 234. The value of this offset distance may be engraved within the offset plate 232 of the radius offset insert or otherwise indicated. In a particular embodiment, the radius offset insert 210 has an offset dimension value (r) of 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, or 5.0 mm.

[0045] Figures 11 to 18 illustrate additional views of the radius offset insert 210 of FIG. 2. FIG. 11 shows the radius offset insert 210 and the offset (r) between the central longitudinal axis 233 of the offset plate 232 and the central longitudinal axis 235 of the circular guide portion 234. The offset r may be 0.5, 1.5, 2.5, 3.0 mm, or may be within the range defined by any two of these values. FIG. 11 also illustrates the base 205 and the orientation angle (beta) between the base 205 and the radius offset insert 210. The ring 207 shown within the base 205 corresponds to the possible center position of the offset plate 232 of the radius offset insert 210 when inserted into the base 205. For example, the innermost ring corresponds to the possible center position of the offset plate 232 of the radius offset insert 210 having an offset r value of 0.5 mm. Moving outward, the next ring corresponds to the possible center position of the offset plate 232 of the radius offset insert 210 having an offset r value of 1.5 mm. The outermost ring corresponds to the possible center position of the offset plate 232 of the radius offset insert 210 having an offset r value of 2.5 mm.

[0046] FIG. 12 illustrates a radius offset insert 210 having a locking mechanism similar to the locking mechanism of the base component 205 of FIG. 4. The radius offset insert 210 of FIG. 12 can be used with the guide base component 205 of FIG. 4. Similar to the description of the base slot 402 and the key with respect to FIG. 4, the radius offset insert 210 may use a similar locking mechanism (not shown) for fixing the radius offset insert 210 to the K-wire guide tube insert 215. For example, the radius offset insert 210 may include a radius offset slot 1202 and an optional radius offset notch (not shown, but which may optionally be disposed opposite the radius offset slot 1202). In some embodiments, the key may be inserted into the slot 1202 and rotated so that the cylindrical cavity 236 expands to accommodate the K-wire guide tube 215 (“open configuration”). In some embodiments, after the K-wire guide tube insert 215 is disposed, the key may be rotated to the closed position so that the walls of the slot 1202 can move closer to each other. The key is then removed from the radius offset slot 1202 to contract the cylindrical cavity 236 and compress the K-wire guide tube insert 215 when inserted into the cylindrical cavity 236. By tightening the cylindrical cavity 236 around the K-wire guide tube insert 215, they are locked in place relative to each other and prevented from further moving or rotating relative to each other. In some embodiments, the same key may be used to open and close the base slot 402 of the base 205 and the radius offset slot 1202 of the radius offset insert 210.

[0047] Figures 13 to 18 illustrate additional views of the radius offset insert 210 of FIG. 12. FIG. 13 illustrates a top view or bird's-eye view of the radius offset insert 210. FIG. 14 illustrates a bottom view of the radius offset insert 210. FIGS. 15 and 16 illustrate side views of the radius offset insert 210. FIGS. 17 and 18 illustrate front and rear views of the radius offset insert 210.

[0048] The rear surface 242 of the offset plate 232 can be configured to contact the front surface 244 (see FIG. 4) of the guide base component 205 and rotate circumferentially around the front surface 244 when the radius offset insert 210 is inserted into the guide base component 205 and angularly / rotationally oriented with respect to the guide base component 205. For example, the shoulder implant planning system 100 can determine a parameter 120 including the offset dimension (r) and rotational orientation (beta, β) of the appropriate radius offset insert of the radius insert 210 with respect to the guide base component 205 based on the implant and implant orientation specified by the clinician during the surgical planning phase. Indicators on the radius offset insert 210 and / or the guide base component 205 or alignment disk (described in more detail below) may be used to place the radius offset insert 210 in the correct rotational orientation (beta, β) with respect to the guide base component 205. The indicator may be displayed in degrees of rotation (e.g., 0 to 360 degrees) or clock time units (e.g., 0 to 12 o'clock).

[0049] Referring again to FIG. 2, the K-wire guide tube insert 215 includes a guide tube 250 and a tube plate 260. The guide tube 250 includes a central lumen sized to receive a K-wire (e.g., a 2.4 mm diameter K-wire, or a K-wire of another diameter). The angular orientation (alpha, α) of the K-wire guide tube insert 215 relative to the tube plate 260 varies based on the particular K-wire guide tube insert 215 identified by the shoulder implant planning system. The K-wire guide tube insert 215 can have an angular orientation (alpha, α) of 0, 5, 10, 15, 20 degrees, or other angles relative to its tube plate 260, as shown in FIG. 19.

[0050] FIGS. 19-26 illustrate additional views of the K-wire guide tube insert 215. FIG. 19 shows the K-wire guide tube insert 215 of FIG. 2. The illustrated inclination angle of the K-wire guide tube insert 215 is 15 degrees; however, the insert 215 may comprise a tube 250 oriented at 0, 5, 10, 15 degrees, or any other angle relative to the plate 255. FIG. 19 also illustrates a radius offset insert 210 inserted into the guide base component 205 and oriented at an angle β relative to the guide base component 205. FIG. 19 also illustrates the K-wire guide tube insert 215 inserted into the radius offset insert 210 and disposed inside the guide base component 205. The K-wire guide tube insert 215 is oriented at an angle lambda (λ) relative to the guide base component 205. The method of orienting the radius offset insert 210 and the K-wire guide tube insert 215 relative to the guide base component 205 will be described in more detail below with respect to FIGS. 29-52.

[0051] Figures 20 - 26 illustrate additional views of the K - wire guide tube insert 215 that can be used with the radius offset insert 210 of FIG. 12 and the guide base component 205 of FIG. 4. FIG. 20 illustrates a perspective view of the K - wire guide tube insert 215 of FIG. 19. FIG. 21 illustrates a top view or bird's - eye view of the K - wire guide tube insert 215 of FIG. 20. FIG. 22 illustrates a bottom view of the K - wire guide tube insert 215 of FIG. 20. FIGS. 23 and 24 illustrate side views of the K - wire guide tube insert 215 of FIG. 20. FIGS. 25 and 26 illustrate front and rear views of the K - wire guide tube insert 215 of FIG. 20.

[0052] The selected K - wire guide tube 250 also has a cylindrical mounting region 240 sized to fit and rotate within the cylindrical cavity 236 of the radius offset insert 210 (see, for example, FIG. 13). The K - wire guide tube insert 215 may optionally have an indicator (e.g., located on its tube plate 260) that enables rotational alignment of the K - wire guide tube insert 215 with respect to the guide base component. The angular rotational alignment (lambda, δ) may be expressed in degrees (e.g., 0 - 360 degrees) or in terms of clock time (e.g., 0 - 12 o'clock).

[0053] Figures 27 and 28 both illustrate selected components of the instrument components of FIG. 2 that are assembled and oriented relative to each other according to parameters 120 determined by the shoulder implant planning system 100 of FIG. 1. FIG. 27 illustrates a customizable and reusable alignment tool assembled from the guide base component 205, radius offset insert 210, and K-wire guide tube insert 215 described above. When components 205, 210, 215 are assembled and fixed together, they can be used by a clinician to guide the placement and angular orientation of the K-wire relative to the patient's glenoid fossa. To orient the radius offset insert 210 and the K-wire guide tube insert 215 relative to the guide base component 205, it can be accomplished using one or more alignment plates, or orientation guides, as described in more detail below with respect to FIGS. 29-52.

[0054] Figures 29 to 35 illustrate an exemplary alignment compass base 800. As shown in Figure 29, the alignment compass base 800 includes a base component 205 and an opening 802 configured to receive a rotational orientation marker (in degrees). In some embodiments, the alignment compass base 800 may be configured to receive the guide base component 205 such that the pin-shaped leg 220 disposed on the upper surface of the guide base component 205 can be at 0 degrees. On the front side of the alignment compass base 800, markings are included that indicate the angular orientation of the radius offset insert 210 and the K-wire guide tube insert 215 relative to the guide base component 205. In some embodiments, as described below, the radius offset insert 210 and subsequent components can be arranged and oriented while the guide base component 205 is being placed within the alignment compass base 800. Figures 30 to 35 illustrate additional views of the alignment compass base 800 that can be used to rotationally orient the guide base component 205, the radius offset insert 210, and the K-wire guide tube insert 215 relative to each other. Figure 30 illustrates a top view or bird's-eye view of the alignment compass base 800. Figure 31 illustrates a bottom view of the alignment compass base 800. Figures 32 and 33 illustrate side views of the alignment compass base 800. Figures 34 and 35 illustrate a top view and a bottom view of the alignment compass base 800.

[0055] Figure 36 illustrates the arrangement of the guide base component 205 within the opening 802 of the alignment compass base 800. The guide base component 205 is oriented at 0 degrees relative to the alignment compass base 800 when inserted into the opening 802.

[0056] Figures 37-39 illustrate an exemplary radius pointer, or alignment plate 3700, that can be used to align the radius offset insert 210 with respect to the guide base component 205. As shown in FIG. 37, the radius pointer 3700 includes a radius offset insert opening 3701 and an angle indicator tip 3702. In some examples, the radius pointer 3700 may be configured to rotate the radius offset insert 210 with respect to the guide base component 205. For example, after inserting the guide base component 205 into the alignment compass base 800 and adjusting it to the "open configuration", the radius offset insert 210 is inserted into the opening of the guide base component 205. The radius pointer 3700 is temporarily placed on the radius offset insert 210 and rotated with respect to the alignment compass base 800 until the angle indicator tip 3702 is aligned with the desired angle indicator on the alignment compass base 800. When in a fixed position, the radius offset insert 210 is locked in place (e.g., by rotating a key to the closed position and removing it from the slot 402 of the guide base component 205). FIG. 40 illustrates the placement of the radius offset insert 210 within the guide base component 205, disposed within the alignment compass base 800. In some examples, the radius offset notch 3701 can be adapted around the radius offset insert 210 such that the side of the offset plate 232 can contact the side of the radius offset insert opening 3701. When the radius offset insert opening 3701 is placed over the radius offset insert 210, the radius pointer 3700 can be rotated to change the angular orientation of the radius offset insert 210 with respect to the guide base component 205. FIG. 41 illustrates the placement of the radius pointer 3700 on the radius offset insert 210 in an exemplary configuration.

[0057] As described above, the shoulder implant planning system 100 can determine parameters 120 including the offset dimension (r) and rotational orientation (beta, β) of the appropriate radius offset insert for the radius insert 210 relative to the guide base component 205, based on the implant and implant orientation specified by the clinician during the surgical planning phase. In some embodiments, the radius tip 3702 may be used to set the rotational orientation of the radius offset insert 210. For example, the angular orientation of the radius offset insert 210 can be adjusted by rotating the radius pointer 3700 such that the radius tip 3702 aligns in a row with a particular scale of the rotational orientation marker on the alignment compass base 800.

[0058] Figures 42-44 illustrate an exemplary K-wire pointer, or alignment plate 4200. As shown in Figure 42, the K-wire pointer 4200 includes an opening 4201 for the K-wire guide tube, a K-wire pointer tip, or angular alignment indicator tip 4202. In some examples, the K-wire pointer 4200 may be configured to rotate the K-wire guide tube insert 215 relative to the radius offset insert 210 and the guide base component 205. For example, after orienting and locking the radius offset insert 210 directly above the guide base component 205, a key may be inserted into and rotated within a slot 1202 of the radius offset insert 210 to configure the radius offset insert 210 in an open configuration. Next, as shown in Figure 45, the K-wire guide tube insert 215 may be disposed within a cylindrical cavity 236 of the radius offset insert 210.

[0059] Next, as shown in FIG. 46, the K-wire pointer 4200 may be placed on the K-wire guide tube insert 215. In this example, the K-wire pointer 4200 can be used to orient the K-wire guide tube insert 215 to a desired angle before locking the K-wire guide tube insert 215 in place (e.g., before rotating the key to close and removing it from the radius offset insert 210). In some examples, the K-wire pointer 4200 can be adapted around the K-wire guide tube insert 215 such that the side of the tube plate 260 contacts the side of the opening 4201 for the K-wire guide tube. In some embodiments, when the opening 4201 for the K-wire guide tube is placed on the K-wire guide tube insert 215, the tip 4202 of the K-wire pointer can be rotated so that the angular orientation of the K-wire guide tube insert 215 relative to the radius offset insert 210 and the guide base component 205 is changed. FIG. 46 illustrates the placement of the K-wire pointer 4200 on the K-wire guide tube insert 215 in an exemplary configuration.

[0060] With the shoulder implant planning system 100, the rotation and inclination of the implant during the surgical planning and simulation stages are likewise determined. With the shoulder implant planning system, the rotation and inclination of the implant are determined based on the placement and orientation of the implant used by the clinician in the virtual glenoid fossa model. The shoulder implant planning system 100 can convert the rotation and inclination of the implant into corresponding angular orientations (alpha, α) and rotational orientations (delta, δ) of the K-wire tube 250 of the K-wire guide tube insert 215 relative to the guide base component 205. This angular orientation and rotational orientation of the K-wire tube 250 relative to the guide base component 205 ensures that when the K-wire 255 is inserted into the K-wire tube 250, it is placed in the correct orientation. With the correct orientation, it becomes possible to drill the glenoid fossa to achieve the position and orientation of the implant pins specified by the clinician via the shoulder implant planning system 100. In some embodiments, the K-wire pointer tip 4202 can be used to set the rotational orientation of the K-wire guide tube insert 215 relative to the guide base component 205. For example, the angular orientation of the K-wire guide tube insert 215 can be adjusted by adjusting the K-wire pointer 4202 such that the K-wire pointer tip 4200 aligns with a specific scale of the rotational orientation marker on the alignment compass base 800.

[0061] Figures 47-52 illustrate additional views of the fully assembled selected components of the instrument components of FIG. 2 and the orientation guide.

[0062] The shoulder implant planning system 100 and the instrument components 200 can be used for a clinician to plan and simulate an artificial shoulder joint replacement surgical procedure, specify the exact instruments to be used to complete the surgical procedure, accurately specify how each component of the instrument should be oriented relative to each other (as shown in FIG. 27), and then enable the clinician to complete the surgical procedure using the specified instruments. For example, to achieve the same results achieved during planning and simulation with a virtual glenoid model, once completed, the K-wire guide tube is placed in the patient's glenoid and angularly oriented so that the clinician can insert the K-wire 255 into the K-wire guide tube 250, remove all the instrument components 200, and complete the implant surgery.

[0063] In one embodiment, a surgical planning method 5300 using the shoulder implant planning system 100 is illustrated in FIG. 53. The shoulder joint implant planning system receives an image of the patient's glenoid 5304 and generates a virtual glenoid model 5306. The shoulder implant planning system also receives an indication of a desired implant, the position of the desired implant, and the angular orientation (e.g., rotation and tilt) of the desired implant 5308. Using this information, the shoulder implant planning system determines (1) an appropriate guide base component having a predetermined size, (2) an appropriate radius offset insert having a predetermined offset value (r), (3) an appropriate rotational orientation (beta, β) of the radius offset insert relative to the guide base component, (4) an appropriate K-wire guide tube insert having a guide tube angled at a predetermined angular orientation (alpha, α) relative to the tube base plate, and (5) an appropriate rotational orientation (delta, δ) of the K-wire guide tube insert relative to the guide base component 5310, 5312. The identification of these values and components can be provided to the clinician via the output display of the shoulder implant planning system.

[0064] During the surgical procedure, the clinician selects the appropriate guide base component, radius offset insert, and K-wire guide tube from a stock or kit of standard, reusable instrument components. The clinician surgically accesses the patient's glenoid fossa and positions the guide base component in place. The radius offset component is inserted into the guide base component and rotated to a specific rotational orientation (beta, β) relative to the guide base component. The K-wire guide tube insert is inserted into the cylindrical cavity of the radius offset insert and rotated to a specific rotational orientation (delta, δ) relative to the guide base component. The clinician then actuates the locking mechanism of the guide base component to lock the instrument components in a fixed position relative to each other.

[0065] The clinician can then insert a K-wire through the guide tube of the K-wire guide tube insert into the patient's glenoid fossa. When the guide base component, radius offset insert, and K-wire guide tube are removed, the K-wire remains implanted at the target position and angular orientation relative to the patient's glenoid fossa. The glenoid fossa can further be prepared for implantation of the surgical implant by drilling an opening along the axis of the K-wire. The diameter and depth of the opening are sized to accommodate a peg, post, or pin located on the upper side of the base plate of the shoulder implant.

[0066] In some embodiments, a method of preparing an instrument guide includes receiving parameters related to a guide base component 205 (e.g., size such as small, medium, large, extra-large, etc.), a radius offset insert 210 (e.g., offset value), and a K-wire guide tube insert 215 (e.g., angle of the tube relative to the plate) and orientation values (e.g., angular orientation of the radius offset insert 210 relative to the guide base component 205 and angular orientation of the K-wire guide tube insert 215 relative to the guide base component 205, etc.). The method also includes assembling and orienting relative to each other the guide base component 205, the radius offset insert 210, and the K-wire guide tube insert 215 as described above.

[0067] (Other considerations) In some embodiments, systems and components as described herein can take the form of a computing system that communicates with one or more computing systems and / or one or more data sources via one or more networks. A computing system may be used to implement one or more of the systems and methods described herein. Although various embodiments illustrating computing systems and components are described herein, it is recognized that the functions provided within the components and modules (which may also be referred to herein as engines) of a computing system may be combined into fewer components and modules, or further separated into additional components and modules. Examples of modules include components such as software components, object-oriented software components, class components and task components, processes, functions, attributes, procedures, subroutines, segments of program code, drivers, firmware, microcode, circuits, data, databases, data structures, tables, arrays, and variables. Any module can be executed on one or more CPUs.

[0068] The software module may be linked to an executable program by compilation, installed in a dynamic link library, or written in an interpreted programming language such as BASIC, Perl, or Python (registered trademark), for example. It will be understood that the software module may be called from other modules or from itself and / or launched in response to detected events or interrupts. The software instructions may be embedded in firmware such as an EPROM. It will further be understood that the hardware module may be composed of connected logic units such as gates and flip-flops and / or programmable units such as programmable gate arrays or processors. The modules described herein can be implemented as software modules, but can also be represented by hardware or firmware. Generally, the modules described herein refer to logical modules that may be combined with other modules or divided into sub-modules regardless of their physical configuration or physical storage. In addition, all methods described herein may be executed as instructions on a CPU and may cause operations or transformations of data.

[0069] In some embodiments, the hardware components of the system include a CPU, which may include one, two, or more conventional microprocessors. The system further includes memories such as random access memory ("RAM") for temporarily storing information and read-only memory ("ROM") for permanently storing information, and mass storage devices such as hard drives, flash drives, floppy disks, or optical media storage devices. Typically, the modules of the system are connected using a standard-based bus system. In different embodiments, the standard-based bus system can be, for example, Peripheral Component Interconnect ("PCI"), Micro Channel, Small Computer System Interface ("SCSI"), Industrial Standard Architecture ("ISA"), and Extended ISA ("EISA").

[0070] In some embodiments, the system and their components can be operably coupled to destination modalities that can be, for example, email or other messaging modalities; SAMBA, Windows® or other file sharing modalities; FTP or SFTP server modalities; VPN; printers, etc. According to some embodiments, the system can be a software or a hardware-software system. For example, the system can include a communication engine configured to receive and transmit information.

[0071] According to some embodiments, the communication engine may be any software or hardware-software system configured to receive and / or transmit data. The communication engine may be configured to transmit and receive data on various network interfaces including wired and wireless networks or combinations thereof, for example, via Ethernet®, 802.1lx, Bluetooth®, FireWire®, GSM, CDMA, LTE®, etc. The communication engine may also be configured to transmit and / or receive data by file transfer protocols such as TCP / IP, and by various encryption protocols such as, for example, WEP, WPA, WPA2, etc.

[0072] Needless to say, various other modifications, adaptations, and alternative designs are possible in view of the above teachings. Therefore, it should be understood that the present invention may be practiced otherwise than as specifically described herein within the scope of the appended claims. It is contemplated that various combinations or sub-combinations of the specific features and aspects of the embodiments disclosed above may be made and still be included within one or more of the present inventions. Further, the disclosure herein of any specific features, aspects, methods, characteristics, features, qualities, attributes, elements, etc. related to an embodiment can be used in all other embodiments described herein. Therefore, it should be understood that the various features and aspects of the disclosed embodiments can be combined with or replaced by each other to form various modes of the disclosed invention. Therefore, it is intended that the scope of the invention disclosed herein should not be limited to the specific disclosed embodiments described above. Further, while the present invention is capable of receiving various modifications, alternative forms, specific examples thereof are shown in the drawings and described in detail herein. However, the present invention is not limited to the specific forms or methods disclosed, but on the contrary, the present invention encompasses all modifications, equivalents, and alternatives included within the spirit and scope of the various embodiments described and the appended claims. Any method disclosed herein need not be performed in the order explicitly recited. The scope disclosed herein includes any and all overlaps, sub-ranges, and combinations thereof. Words such as "maximum", "at least", "more than", "less than", "between ~" include the stated numbers. As used herein, terms such as "approximately", "about", and "substantially" preceding a number include the specified number (e.g., about 10% = 10%) and also represent an amount close to the specified amount that still performs the desired function or achieves the desired result. For example, the terms "approximately", "about", and "substantially" can refer to amounts within the range of less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the specified amount.

Claims

1. Providing an alignment compass base configured to enable rotational orientation of a radius offset insert and a K-wire guide tube with respect to a guide base; Inserting the guide base component into the alignment compass base; Inserting the radius offset insert into the guide base component; Rotating the radius offset insert to a first orientation angle with respect to the guide base component using a first alignment tool; Inserting the K-wire guide tube into the radius offset insert; Rotating the K-wire guide tube to a second orientation angle with respect to the guide base component using a second alignment tool; A method comprising the above steps.

2. The guide base component includes an opening configured to receive a key, The step of inserting the radius offset insert into the guide base component includes the step of expanding the opening by rotating the key, according to the method of Claim 1.

3. The step of rotating the radius offset insert to the first orientation angle further includes the step of contracting the opening by rotating the key of the opening, according to the method of Claim 2.

4. The radius offset insert includes an opening configured to receive a key, The step of inserting the K-wire guide tube into the radius offset insert includes the step of expanding the opening by rotating the key of the opening, according to the method of Claim 1.

5. The step of rotating the radius offset insert to the first orientation angle further includes the step of contracting the opening by rotating the key of the opening, according to the method of Claim 4.

6. The first alignment tool is a disk or plate, according to the method of Claim 1.

7. The first alignment tool includes an opening shaped to receive an outer peripheral portion of the radius offset insert and configured to contact the side surface of the radius offset insert when rotating, according to the method of Claim 1.

8. The second alignment tool is a disk or plate, according to the method of Claim 1.

9. The method according to claim 8, wherein the second alignment tool includes an opening shaped to receive an outer peripheral portion of the K-wire guide tube and is configured to contact a side surface of the radius offset insert when rotating.

10. The method according to claim 1, further comprising the step of rotating the first alignment tool and the second alignment tool relative to the alignment compass base.

11. A customizable artificial shoulder joint replacement device, An alignment compass base configured to enable rotational orientation of a radius offset insert and a K-wire guide tube relative to a guide base, The guide base component configured to be inserted into the alignment compass base, The radius offset insert configured to be inserted into the alignment compass base, wherein the radius offset insert can be rotated to a first orientation angle relative to the guide base component using a first alignment tool, The K-wire guide tube configured to be inserted into the radius offset insert, wherein the K-wire guide tube can be rotated to a second orientation angle relative to the guide base component using a second alignment tool, A customizable artificial shoulder joint replacement device comprising the above.

12. The guide base component includes an opening configured to receive a key, The customizable artificial shoulder joint replacement device according to claim 11, wherein the radius offset insert can be adapted to the guide base component by expanding the opening by rotating the key in the opening.

13. The customizable artificial shoulder joint replacement device according to claim 12, wherein the radius offset insert can be adapted to the guide base component by contracting the opening by rotating the key in the opening.

14. The radius offset insert includes an opening configured to receive a key, The step of inserting the K-wire guide tube into the radius offset insert includes the step of expanding the opening by rotating the key of the opening, the customizable artificial shoulder joint replacement device according to claim 11.

15. The step of rotating the radius offset insert to the first orientation angle further includes the step of contracting the opening by rotating the key of the opening, the customizable artificial shoulder joint replacement device according to claim 14.

16. The first alignment tool is a disk or plate, the customizable artificial shoulder joint replacement device according to claim 11.

17. The first alignment tool includes an opening shaped to receive an outer peripheral portion of the radius offset insert and is configured to contact a side surface of the radius offset insert when rotating, the customizable artificial shoulder joint replacement device according to claim 16.

18. The second alignment tool is a disk or plate, the customizable artificial shoulder joint replacement device according to claim 11.

19. The second alignment tool includes an opening shaped to receive an outer peripheral portion of the K-wire guide tube and is configured to contact a side surface of the radius offset insert when rotating, the customizable artificial shoulder joint replacement device according to claim 18.

20. The first alignment tool and the second alignment tool rotate relative to the alignment compass base, the customizable artificial shoulder joint replacement device according to claim 11.

21. A customizable artificial shoulder joint replacement kit, An alignment compass base configured to enable rotational orientation of one radius offset insert and one K-wire guide tube relative to one guide base, The one guide base component among a plurality of guide base components configured to be inserted into the alignment compass base, the plurality of guide base components including guide base components of different sizes, the one guide base component Said one radius offset insert among a plurality of radius offset inserts configured to fit said one guide base component, said plurality of radius offset inserts include radius offset inserts of different sizes, said one radius offset insert, which can be rotated to a first orientation angle with respect to said one guide base component using a first alignment tool, said one K-wire guide tube among a plurality of K-wire guide tubes configured to fit said one radius offset insert, said plurality of K-wire guide tubes include K-wire guide tubes of different sizes, said plurality of K-wire guide tubes, said one K-wire guide tube, which can be rotated to a second orientation angle with respect to said one guide base component using a second alignment tool, A customizable artificial shoulder joint replacement instrument kit comprising.

22. Said one guide base component includes an opening configured to receive a key, The kit according to claim 21, wherein the step of inserting said one radius offset insert into said one guide base component includes the step of expanding said opening by rotating said key.

23. The kit according to claim 22, wherein said one radius offset insert can be inserted into said one guide base component by contracting said opening by rotating said key of said opening.

24. Said one radius offset insert includes an opening configured to receive a key, The kit according to claim 21, wherein the step of inserting said one K-wire guide tube into said one radius offset insert includes the step of expanding said opening by rotating said key of said opening.

25. The kit according to claim 24, wherein the step of rotating said one radius offset insert to said first orientation angle further includes the step of contracting said opening by rotating said key of said opening.

26. The kit according to claim 21, wherein said first alignment tool is a disk or a plate.

27. The kit according to claim 26, wherein the first alignment tool includes an opening shaped to receive an outer peripheral portion of the one radius offset insert and is configured to contact a side surface of the one radius offset insert when rotating.

28. The kit according to claim 21, wherein the second alignment tool is a disk or a plate.

29. The kit according to claim 28, wherein the second alignment tool includes an opening shaped to receive an outer peripheral portion of the one K-wire guide tube and is configured to contact a side surface of the one radius offset insert when rotating.

30. The kit according to claim 21, wherein the first alignment tool and the second alignment tool rotate with respect to the alignment compass base.

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