Implants, Instruments, Systems, and Methods of Use
Patent Information
- Application Number
- JP2024506468
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-08-02
- Filing Date
- 2022-08-02
- Publication Date
- 2025-07-02
AI Technical Summary
Current treatments for bone deformities in the foot and ankle, such as ankle fusion surgeries, face challenges with unpredictable bone loss patterns, difficulty in achieving a proper fit due to variable bone defects, and complications from existing implants like femoral head allografts and custom PSI, which can lead to resorption, structural weakness, or leg shortening.
The development of implants with an inner frame, outer frame, and lattice structure, along with insertion tools and precision guides, allows for precise implant placement and secure fixation, addressing bone deformities by providing a customizable and stable solution.
The implants and systems enable accurate correction of bone deformities, minimizing healthy bone resection and reducing complications, while ensuring a stable and secure fit, thereby improving surgical outcomes.
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Abstract
Description
[Technical field]
[0001] The present invention relates generally to general surgical, podiatric, and orthopedic implants and instruments used to insert implants for correcting bone deformities. More specifically, but not by way of limitation, the present invention relates to implants, instruments, and systems for correcting bone deformities, and methods for using the implants, instruments, and systems. [Background technology]
[0002] Ankle fusion surgeries are commonly performed using a combination of hardware including screw fixation, intramedullary nails, and plate-screw combinations. These surgeries are most typically performed to treat osteoarthritis and Charcot.
[0003] A portion of ankle fusion cases involve large bone defects in the hindfoot whereby any number of factors result in a talar void that must be filled prior to fusion or result in shortening of the leg due to tibial-calcaneal union. Pathologies that can lead to large talar voids include Charcot, failed total ankle replacement (TAR) that must be removed, and / or avascular necrosis of the talus.
[0004] Currently, standard of care to fill these voids and associated shortcomings include femoral head allograft, custom patient specific instrumentation (PSI), or talocalcaneal (TC) fusion. The use of femoral head allograft surgery can result in resorption and structural weakness. Custom PSI can result in annual limitations on the number of surgeries and increased demands on preoperative planning. On the other hand, TC fixation can result in leg shortening.
[0005] Furthermore, for all currently available options, minimizing resection of healthy bone during preparation can be difficult as the patterns of bone loss associated with these cases are highly variable and unpredictable. Even with PSI, achieving a proper fit can be very challenging due to the gap between the expected cavity shape and / or size from preoperative planning and the intraoperative clinical reality.
[0006] Thus, new implants, instruments, systems, and procedures are needed to improve the insertion of implants to correct bone deformities. Summary of the Invention [Problem to be solved by the invention]
[0007] Embodiments of the present invention provide implants, devices, systems, and methods for correcting bone deformities of the foot and / or ankle. [Means for solving the problem]
[0008] In one aspect, provided herein is an implant that includes an internal frame, an external frame surrounding the internal frame, and a lattice structure extending between at least a portion of the internal frame and the external frame.
[0009] In another aspect, provided herein is a system including an implant and an insertion instrument coupled to an external frame of the implant, the implant including an internal frame, an external frame surrounding the internal frame, and a lattice structure extending between at least a portion of the internal frame and the external frame.
[0010] In yet another aspect, provided herein is an insertion instrument including a handle, an outer shaft coupled to the handle at a first end, and an inner shaft rotatably received within the outer shaft.
[0011] In yet another aspect, provided herein is a precision guide. The precision guide includes an arm and a guide tube housed within the arm. The arm includes a first portion, a second portion, and a connecting portion connected to the first portion at a first end and to the second portion at a second end, the connecting portion angling the first portion relative to the second portion.
[0012] In another aspect, provided herein is a precision guide. The precision guide includes a frame, a guide tube housed within the frame, and at least one angle wing housed within the frame.
[0013] In a further aspect, provided herein is a surgical method. The surgical method includes exposing a joint of a patient and forming a cavity in the joint to receive an implant. The method also includes inserting a trial implant into the cavity to select a desired implant size, and selecting an implant corresponding to the trial implant having the desired implant size. The method further includes coupling the implant to an insertion instrument and inserting the implant coupled to the insertion instrument into the cavity. Additionally, the method includes manipulating the coupled implant and insertion instrument in at least one of rotation and translation to a desired position, and securing the implant to the joint.
[0014] These and other objects, features and advantages of the present invention will become apparent from the following detailed description of the various embodiments of the invention, which is to be read in conjunction with the accompanying drawings. [Brief description of the drawings]
[0015] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present invention and, together with the detailed description herein, serve to explain the principles of the present invention. The drawings are only for the purpose of illustrating preferred embodiments and are not to be construed as limiting the present invention. It is emphasized that, in accordance with standard industry practice, various features are not drawn to scale. In fact, dimensions of various features may be arbitrarily increased or decreased for clarity of illustration. These and other objects, features and advantages of the present invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings.
[0016] [Figure 1] FIG. 1 is a first perspective view of an implant according to one embodiment of the present disclosure. [Diagram 2] FIG. 2 is a second perspective view of the implant of FIG. 1 according to one embodiment of the present disclosure. [Diagram 3] FIG. 2 is a first end view of the implant of FIG. 1 according to one embodiment of the present disclosure. [Figure 4] FIG. 2 is a second end view of the implant of FIG. 1 according to one embodiment of the present disclosure. [Diagram 5] FIG. 2 is a first side view of the implant of FIG. 1 according to one embodiment of the present disclosure. [Figure 6] FIG. 2 is a second side view of the implant of FIG. 1 according to one embodiment of the present disclosure. [Figure 7] FIG. 2 is a top view of the implant of FIG. 1 according to one embodiment of the present disclosure. [Figure 8] FIG. 2 is a bottom view of the implant of FIG. 1 according to one embodiment of the present disclosure. [Figure 9] 9 is a cross-sectional view of the implant of FIG. 1 taken along line 9-9 of FIG. 5 according to one embodiment of the present disclosure. [Figure 10] 1 along line 10-10 of FIG. 3 according to one embodiment of the present disclosure. [Figure 11] 2 is another perspective view of the implant of FIG. 1 including a lattice structure inserted into an opening of the implant of FIG. 1 according to one embodiment of the present disclosure. [Figure 12]FIG. 12 is a top view of a portion of a lattice structure inserted into the implant of FIG. 11 according to one embodiment of the present disclosure. [Figure 13] FIG. 13 is a first perspective view of another implant according to one embodiment of the present disclosure. [Figure 14] FIG. 14 is a second perspective view of the implant of FIG. 13 according to one embodiment of the present disclosure. [Figure 15] FIG. 14 is a first end view of the implant of FIG. 13 according to one embodiment of the present disclosure. [Figure 16] FIG. 14 is a second end view of the implant of FIG. 13 according to one embodiment of the present disclosure. [Figure 17] FIG. 14 is a first side view of the implant of FIG. 13 according to one embodiment of the present disclosure. [Figure 18] FIG. 14 is a second side view of the implant of FIG. 13 according to one embodiment of the present disclosure. [Figure 19] FIG. 14 is a top view of the implant of FIG. 13 according to one embodiment of the present disclosure. [Figure 20] FIG. 14 is a bottom view of the implant of FIG. 13 according to one embodiment of the present disclosure. [Figure 21] 21 is a first end view of a cross-section of the implant of FIG. 13 taken along line 21-21 of FIG. 17 according to one embodiment of the present disclosure. [Figure 22] 22 is a second end view of a cross-section of the implant of FIG. 13 taken along line 22-22 of FIG. 18 according to one embodiment of the present disclosure. [Figure 23] 23 is a side view of a cross-section of the implant of FIG. 13 taken along line 23-23 of FIG. 15 according to one embodiment of the present disclosure. [Figure 24] FIG. 13 is a first perspective view of yet another implant according to an embodiment of the present disclosure. [Diagram 25] FIG. 25 is a second perspective view of the implant of FIG. 24 according to one embodiment of the present disclosure; and [Figure 26] FIG. 25 is a first end view of the implant of FIG. 24 according to one embodiment of the present disclosure. [Figure 27] FIG. 25 is a second end view of the implant of FIG. 24 according to one embodiment of the present disclosure. [Figure 28]FIG. 25 is a first side view of the implant of FIG. 24 according to one embodiment of the present disclosure. [Figure 29] FIG. 25 is a second side view of the implant of FIG. 24 according to one embodiment of the present disclosure. [Diagram 30] FIG. 25 is a top view of the implant of FIG. 24 according to one embodiment of the present disclosure. [Diagram 31] FIG. 25 is a bottom view of the implant of FIG. 24 according to one embodiment of the present disclosure. [Diagram 32] 22 is a first end view of a cross-section of the implant of FIG. 24 taken along line 32-32 of FIG. 28 according to one embodiment of the present disclosure. [Diagram 33] 33 is a second end view of a cross-section of the implant of FIG. 24 taken along line 33-33 of FIG. 29 according to one embodiment of the present disclosure. [Diagram 34] 34 is a side view of a cross-section of the implant of FIG. 24 taken along line 34-34 of FIG. 26 according to one embodiment of the present disclosure. [Diagram 35] FIG. 13 is a first perspective view of another implant according to one embodiment of the present disclosure. [Diagram 36] FIG. 36 is a second perspective view of the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 37] FIG. 36 is a first end view of the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 38] FIG. 36 is a second end view of the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 39] FIG. 36 is a first side view of the implant of FIG. 35 according to one embodiment of the present disclosure. [Diagram 40] FIG. 36 is a second side view of the implant of FIG. 35 according to one embodiment of the present disclosure. [Diagram 41] FIG. 36 is a top view of the implant of FIG. 35 according to one embodiment of the present disclosure. [Diagram 42] FIG. 36 is a bottom view of the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 43A] FIG. 43A is a first end view of a cross-section of the implant of FIG. 35 taken along line 43A-43A of FIG. 39 according to one embodiment of the present disclosure. [Figure 43B]43B is a second end view of a cross-section of the implant of FIG. 35 taken along line 43B-43B of FIG. 40 according to one embodiment of the present disclosure. [Figure 44A] 44A is a first side view of a cross-section of the implant of FIG. 35 taken along line 44A-44A of FIG. 37 according to one embodiment of the present disclosure. [Figure 44B] 44B is a second side view of a cross-section of the implant of FIG. 35 taken along line 44B-44B of FIG. 38 according to one embodiment of the present disclosure. [Diagram 45] FIG. 36 is a perspective view of the implant of FIG. 35 including a lattice structure inserted into an opening of the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 46] FIG. 2 is a side view of a reamer according to one aspect of the present disclosure. [Figure 47] FIG. 47 is a bottom view of the reamer of FIG. 46 according to one embodiment of the present disclosure. [Figure 48] FIG. 47 is a first cross-sectional view of the reamer of FIG. 46 and a reamer driver coupled to the reamer, according to one embodiment of the present disclosure. [Figure 49] FIG. 47 is a second cross-sectional view of the reamer of FIG. 46 and a reamer driver coupled to the reamer, according to one embodiment of the present disclosure. [Figure 50] FIG. 47 is a top perspective view of the two reamers of FIG. 46 according to one embodiment of the present disclosure. [Figure 51] FIG. 47 is a bottom perspective view of the reamer of FIG. 46 according to one embodiment of the present disclosure. [Figure 52] FIG. 1 is a first perspective view of an insertion tool according to one embodiment of the present disclosure. [Figure 53] FIG. 53 is a second perspective view of the insertion instrument of FIG. 52 according to one embodiment of the present disclosure. [Figure 54] FIG. 53 is a first side view of the insertion instrument of FIG. 52 according to one embodiment of the present disclosure. [Figure 55] FIG. 53 is a second side view of the insertion instrument of FIG. 52 according to one embodiment of the present disclosure. [Figure 56] FIG. 53 is an end view of the insertion instrument of FIG. 52 according to one embodiment of the present disclosure. [Figure 57] FIG. 53 is a top view of the insertion instrument of FIG. 52 according to one embodiment of the present disclosure. [Figure 58]FIG. 53 is a bottom view of the insertion instrument of FIG. 52 according to one embodiment of the present disclosure. [Figure 59] FIG. 53 is an exploded perspective view of the insertion tool of FIG. 52 according to one embodiment of the present disclosure. [Figure 60] 53 is a first perspective view of the implant of FIG. 35 being inserted into a patient's ankle using the insertion tool of FIG. 52 according to one embodiment of the present disclosure. [Figure 61] FIG. 36 is a lateral view of the implant of FIG. 35 implanted in a patient's ankle according to one embodiment of the present disclosure. [Figure 62] FIG. 36 is a front view of the implant of FIG. 35 implanted in a patient's ankle according to one embodiment of the present disclosure. [Figure 63] FIG. 36 is a first perspective view of the implant of FIG. 35 implanted in a patient's ankle according to one embodiment of the present disclosure. [Figure 64] FIG. 53 is a top view of an insertion system including the insertion instrument, alignment member, guide tube, and bone screw of FIG. 52 according to one embodiment of the present disclosure. [Figure 65] FIG. 65 is a first end view of the insertion system of FIG. 64 according to one embodiment of the present disclosure. [Figure 66] FIG. 65 is a perspective view of the insertion system of FIG. 64 according to one embodiment of the present disclosure. [Figure 67] 65 is an exploded top view of the insertion instrument of FIG. 52, the alignment member of FIG. 64, and the guide tube of FIG. 64 according to one embodiment of the present disclosure. [Figure 68] FIG. 68 is an exploded perspective view of the insertion tool of FIG. 67 according to one embodiment of the present disclosure. [Figure 69] FIG. 68 is an exploded end view of the insertion tool of FIG. 67 according to one embodiment of the present disclosure. [Figure 70] FIG. 65 is a lateral side view of the insertion system of FIG. 64 coupled to a patient's ankle and the implant of FIG. 35 inserted into the patient's ankle, according to one embodiment of the present disclosure. [Figure 71] FIG. 71 is an anterior view of the ankle of the patient of FIG. 70 with the insertion system of FIG. 64 and the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 72]FIG. 71 is a lateral perspective view of the ankle of the patient of FIG. 70 with the insertion system of FIG. 64 and the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 73] FIG. 65 is an end view of the insertion system of FIG. 64 and the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 74] FIG. 65 is a first perspective view of the insertion system of FIG. 64 and the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 75] FIG. 65 is a second perspective view of the insertion system of FIG. 64 and the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 76] FIG. 65 is a bottom view of the insertion system of FIG. 64 and the implant of FIG. 35 according to one embodiment of the present disclosure. [Figure 77] FIG. 65 is a perspective view of the implant of FIG. 35 being inserted into a patient's ankle using the insertion system of FIG. 64 according to one embodiment of the present disclosure. [Figure 78] FIG. 78 is a medial side view of FIG. 77 according to one embodiment of the present disclosure. [Figure 79] FIG. 78 is a front perspective view of FIG. 77 according to one embodiment of the present disclosure. [Figure 80] 36 is an image of the implant of FIG. 35 inserted into a patient's ankle according to one embodiment of the present disclosure. [Figure 81] FIG. 13 is a first perspective view of another implant according to one embodiment of the present disclosure. [Figure 82] FIG. 82 is a second perspective view of the implant of FIG. 81 according to one embodiment of the present disclosure. [Figure 83] FIG. 82 is a first end view of the implant of FIG. 81 according to one embodiment of the present disclosure. [Figure 84] FIG. 82 is a second end view of the implant of FIG. 81 according to one embodiment of the present disclosure. [Figure 85] FIG. 82 is a first side view of the implant of FIG. 81 according to one embodiment of the present disclosure. [Figure 86] FIG. 82 is a second side view of the implant of FIG. 81 according to one embodiment of the present disclosure. [Figure 87] FIG. 82 is a top view of the implant of FIG. 81 according to one embodiment of the present disclosure. [Figure 88] FIG. 82 is a bottom view of the implant of FIG. 81 according to one embodiment of the present disclosure. [Figure 89] 89 is a cross-sectional view of the implant of FIG. 81 taken along line 89-89 of FIG. 85 according to one embodiment of the present disclosure. [Figure 90] 80 is a cross-sectional view of the implant of FIG. 81 taken along line 90-90 of FIG. 8 according to one embodiment of the present disclosure. [Figure 91] FIG. 13 is a first perspective view of yet another implant according to an embodiment of the present disclosure. [Figure 92] FIG. 92 is a second perspective view of the implant of FIG. 91 according to one embodiment of the present disclosure. [Figure 93] FIG. 92 is a first end view of the implant of FIG. 91 according to one embodiment of the present disclosure. [Figure 94] FIG. 92 is a second end view of the implant of FIG. 91 according to one embodiment of the present disclosure. [Figure 95] FIG. 92 is a first side view of the implant of FIG. 91 according to one embodiment of the present disclosure. [Figure 96] FIG. 92 is a second side view of the implant of FIG. 91 according to one embodiment of the present disclosure. [Figure 97] FIG. 92 is a top view of the implant of FIG. 91 according to one embodiment of the present disclosure. [Figure 98] FIG. 92 is a bottom view of the implant of FIG. 91 according to one embodiment of the present disclosure. [Figure 99] FIG. 99 is a cross-sectional view of the implant of FIG. 91 taken along line 99-99 of FIG. 97 according to one embodiment of the present disclosure. [Figure 100] 90 is a cross-sectional view of the implant of FIG. 91 taken along line 100-100 of FIG. 98 according to one embodiment of the present disclosure. [Figure 101] 97 is a cross-sectional view of the implant of FIG. 91 taken along line 101-101 of FIG. 97 according to one embodiment of the present disclosure. [Figure 102] 92 is a cross-sectional view of the implant of FIG. 91 taken along line 102-102 of FIG. 98 according to one embodiment of the present disclosure. [Figure 103] FIG. 92 is a perspective view of the implant of FIG. 91 having a lattice structure within the implant according to one embodiment of the present disclosure. [Figure 104] 1 illustrates one embodiment of a surgical method for inserting an implant into a patient's ankle, according to one aspect of the present disclosure. [Figure 105] FIG. 1 illustrates a perspective view of a trial implant system from the anterior according to one aspect of the present disclosure. [Figure 106] FIG. 106 is an enlarged front-side-top perspective view of a trial component of the trial implant system of FIG. 105 according to one embodiment of the present disclosure. [Figure 107] FIG. 107 is an enlarged rear-side-bottom perspective view of the trial component diagram of FIG. 106 according to one embodiment of the present disclosure. [Figure 108] FIG. 107 is a front plan view of the trial component diagram of FIG. 106 according to one embodiment of the present disclosure. [Fig. 109] FIG. 107 is a front plan cross-sectional view of the trial component diagram of FIG. 106 according to one embodiment of the present disclosure. [Figure 110] FIG. 107 is a side cross-sectional view of the trial component diagram of FIG. 106 according to one embodiment of the present disclosure. [Figure 111] FIG. 106 is a perspective view of an insertion tool of the trial implant system of FIG. 105 according to one embodiment of the present disclosure. [Figure 112] FIG. 112 is a side view of the insertion tool of FIG. 111 according to one embodiment of the present disclosure. [Figure 113] FIG. 112 is a front plan view of the insertion tool of FIG. 111 according to one embodiment of the present disclosure. [Fig. 114] FIG. 112 is a top or bottom view of the insertion tool of FIG. 111 according to one embodiment of the present disclosure. [Figure 115] FIG. 1 illustrates an anterior-lateral-proximal / superior perspective view of an implant, an insertion instrument, and a first anterior precision guide according to one embodiment of the present disclosure. [Fig. 116] FIG. 116 is a front view of the implant, insertion instrument, and first anterior precision guide of FIG. 115 according to one embodiment of the present disclosure. [Figure 117] FIG. 116 is a medial side view of the implant, insertion instrument, and first anterior precision guide of FIG. 115 according to one embodiment of the present disclosure. [Fig. 118] FIG. 116 is a perspective exploded view of the first anterior precision guide of FIG. 115 according to one embodiment of the present disclosure. [Figure 119] FIG. 116 is a perspective view of a portion of the first anterior precision guide of FIG. 115 according to one embodiment of the present disclosure. [Figure 120] FIG. 120 is an outer side view of a portion of the first anterior precision guide of FIG. 119 according to one embodiment of the present disclosure. [Figure 121] FIG. 120 is a medial side view of a portion of the first anterior precision guide of FIG. 119 according to one embodiment of the present disclosure. [Figure 122] FIG. 120 is a front view of a portion of the first anterior precision guide of FIG. 119 according to one embodiment of the present disclosure. [Figure 123] FIG. 120 is a rear view of a portion of the first anterior precision guide of FIG. 119 according to one embodiment of the present disclosure. [Figure 124] FIG. 120 is a proximal / top plan view of a portion of the first anterior precision guide of FIG. 119 according to one embodiment of the present disclosure. [Fig. 125] FIG. 120 is a bottom / distal view of a portion of the first anterior precision guide of FIG. 119 according to one embodiment of the present disclosure. [Fig. 126] FIG. 1 illustrates an anterior-lateral-proximal / superior perspective view of an implant, an insertion instrument, and a second anterior precision guide according to one embodiment of the present disclosure. [Figure 127] FIG. 127 is a front view of the implant, insertion instrument, and second anterior precision guide of FIG. 126 according to one embodiment of the present disclosure. [Figure 128] FIG. 127 is a medial side view of the implant, insertion instrument, and second anterior precision guide of FIG. 126 according to one embodiment of the present disclosure. [Figure 129] FIG. 127 is a perspective exploded view of the second anterior precision guide of FIG. 126 according to one embodiment of the present disclosure. [Fig. 130] FIG. 127 is a perspective view of a portion of the second anterior precision guide of FIG. 126 according to one embodiment of the present disclosure. [Fig. 131] FIG. 131 is an outer side view of a portion of the second anterior precision guide of FIG. 130 according to one embodiment of the present disclosure. [Fig. 132] FIG. 131 is a medial side view of a portion of the second anterior precision guide of FIG. 130 according to one embodiment of the present disclosure. [Fig. 133]FIG. 131 is a front view of a portion of the second anterior precision guide of FIG. 130 according to one embodiment of the present disclosure. [Fig. 134] FIG. 131 is a rear view of a portion of the second anterior precision guide of FIG. 130 according to one embodiment of the present disclosure. [Fig. 135] FIG. 131 is a proximal / top plan view of a portion of the second anterior precision guide of FIG. 130 according to one embodiment of the present disclosure. [Fig. 136] FIG. 131 is a bottom / distal view of a portion of the second anterior precision guide of FIG. 130 according to one embodiment of the present disclosure. [Fig. 137] FIG. 1 illustrates a perspective view of a trial implant system from the outside, according to one aspect of the present disclosure. [Figure 138] FIG. 1 illustrates an anterior-lateral-proximal / superior perspective view of an implant, an insertion instrument, and a first outer precision guide according to one embodiment of the present disclosure. [Figure 139] FIG. 139 is a front view of the implant, insertion instrument, and first outer precision guide of FIG. 138 according to one embodiment of the present disclosure. [Fig. 140] FIG. 139 is an outer side view of the implant, insertion instrument, and first outer precision guide of FIG. 138 according to one embodiment of the present disclosure. [Fig. 141] FIG. 1 illustrates an anterior-lateral-proximal / superior perspective view of an implant, an insertion instrument, and a second, lateral precision guide, according to one embodiment of the present disclosure. [Fig. 142] FIG. 142 is a front view of the implant, insertion instrument, and second outer precision guide of FIG. 141 according to one embodiment of the present disclosure. [Fig. 143] FIG. 142 is an outer side view of the implant, insertion instrument, and second outer precision guide of FIG. 141 according to one embodiment of the present disclosure. [Fig. 144] FIG. 142 is an elevated perspective exploded view of the implant, insertion instrument, and second outer precision guide of FIG. 141 according to one embodiment of the present disclosure. [Fig. 145] FIG. 142 is a perspective view of a portion of the second outer precision guide of FIG. 141 according to one embodiment of the present disclosure. [Fig. 146] FIG. 146 is an outer side view of a portion of the second outer precision guide of FIG. 145 according to one embodiment of the present disclosure. [Fig. 147]FIG. 146 is a medial side view of a portion of the second outer precision guide of FIG. 145 according to one embodiment of the present disclosure. [Fig. 148] FIG. 146 is a front view of a portion of the second outer precision guide of FIG. 145 according to one embodiment of the present disclosure. [Figure 149] FIG. 146 is a rear view of a portion of the second outer precision guide of FIG. 145 according to one embodiment of the present disclosure. [Fig. 150] FIG. 146 is a proximal / top plan view of a portion of the second outer precision guide of FIG. 145 according to one embodiment of the present disclosure. [Fig. 151] FIG. 146 is a bottom / distal view of a portion of the second outer precision guide of FIG. 145 according to one embodiment of the present disclosure. [Fig. 152] FIG. 1 illustrates a perspective view of a posterior trial implant system according to one aspect of the present disclosure. [Fig. 153] FIG. 1 illustrates a posterior-medial-proximal / superior perspective view of an implant, an insertion instrument, and a first posterior precision guide according to one embodiment of the present disclosure. [Fig. 154] FIG. 154 is a rear view of the implant, insertion instrument, and first posterior precision guide of FIG. 153 according to one embodiment of the present disclosure. [Fig. 155] FIG. 154 is an outer side view of the implant, insertion instrument, and first posterior precision guide of FIG. 153 according to one embodiment of the present disclosure. [Fig. 156] FIG. 13 illustrates a posterior-medial-proximal / superior perspective view of an implant, an insertion instrument, and a second posterior precision guide according to one embodiment of the present disclosure. [Fig. 157] FIG. 157 is a rear view of the implant, insertion instrument, and second posterior precision guide of FIG. 156 according to one embodiment of the present disclosure. [Fig. 158] FIG. 157 is an outer side view of the implant, insertion instrument, and second posterior precision guide of FIG. 156 according to one embodiment of the present disclosure. [Fig. 159] FIG. 157 is an elevated perspective exploded view of the implant, insertion instrument, and second posterior precision guide of FIG. 156 according to one embodiment of the present disclosure. [Fig. 160] FIG. 157 is a perspective view of a portion of the second posterior precision guide of FIG. 156 according to one embodiment of the present disclosure. [Fig. 161]FIG. 161 is a rear view of a portion of the second posterior precision guide of FIG. 160 according to one embodiment of the present disclosure. [Fig. 162] FIG. 161 is a front view of a portion of the second posterior precision guide of FIG. 160 according to one embodiment of the present disclosure. [Fig. 163] FIG. 161 is an outer side view of a portion of the second posterior precision guide of FIG. 160 according to one embodiment of the present disclosure. [Fig. 164] FIG. 161 is a medial side view of a portion of the second posterior precision guide of FIG. 160 according to one embodiment of the present disclosure. [Fig. 165] FIG. 161 is a bottom / distal plan view of a portion of the second posterior precision guide of FIG. 160 according to one embodiment of the present disclosure. [Fig. 166] FIG. 161 is a proximal / top view of a portion of the second posterior precision guide of FIG. 160 according to one embodiment of the present disclosure. [Fig. 167] FIG. 13 is a front-side-top perspective view of another trial component of the trial implant system according to one aspect of the present disclosure. [Fig. 168] FIG. 168 is a rear-side-bottom perspective view of the trial component diagram of FIG. 167 according to one embodiment of the present disclosure. [Fig. 169] FIG. 168 is a front plan view of the trial component diagram of FIG. 167 according to one embodiment of the present disclosure. [Fig. 170] FIG. 168 is a side view of the trial component diagram of FIG. 167 according to one embodiment of the present disclosure. [Fig. 171] FIG. 168 is a front plan cross-sectional view of the trial component diagram of FIG. 167 according to one embodiment of the present disclosure. [Fig. 172] FIG. 168 is a side cross-sectional view of the trial component diagram of FIG. 167 according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0017] Generally speaking, disclosed herein are implants, instruments, and systems for correcting bone deformities. Additionally, surgical methods for using the implants, instruments, and systems for correcting bone deformities are discussed.
[0018] In this detailed description and in the claims that follow, the terms proximal, distal, anterior or plantar, posterior or dorsal, medial, lateral, superior and inferior are defined by their standard usage to designate specific sites or portions of a bone or an instrument according to the relative placement of natural bones or directional terms of reference. For example, "proximal" refers to the portion of the instrument or instrument closest to the torso, and "distal" refers to the portion of the instrument or instrument furthest from the torso. With respect to directional terms, "anterior" refers to a direction toward the front of the body, "posterior" refers to a direction toward the back of the body, "medial" refers to a direction toward the midline of the body, "lateral" refers to a direction toward either side of the body or away from the midline, "superior" refers to a direction above, and "inferior" refers to a direction below another object or structure. Furthermore, with particular reference to the foot, the term "dorsal" refers to the top portion of the foot, and the term "plantar" refers to the bottom of the foot.
[0019] Similarly, a location or orientation may be used herein with reference to an anatomical structure or surface. For example, the implants, instruments, systems, and methods of the present invention are described herein with respect to use with the bones of the foot, ankle, and lower leg, which may be used to describe the surfaces, locations, directions, or orientations of the implants, instruments, systems, and methods. Furthermore, the implants, devices, instrumentation, systems, and methods disclosed herein, as well as their aspects, components, features, etc., are described with respect to one side of the body for brevity. However, since the human body is relatively symmetrical or mirror image with respect to an axis of symmetry (the midline), it is hereby expressly contemplated that the implants, devices, instrumentation, systems, and methods described and / or exemplified herein, as well as their aspects, components, features, etc., may be changed, mutated, modified, reconfigured, or otherwise altered for use with or in association with another side of the body for the same or similar purposes without departing from the spirit and scope of the present invention. For example, the implants, devices, instrumentation, systems, and methods described herein with respect to the right foot, as well as their aspects, components, features, etc., may be mirror-inverted so that they function similarly with the left foot. Additionally, although the implants, devices, instrumentation, systems and methods disclosed herein, and aspects, components, features, etc., are described with respect to the foot and ankle for simplicity, it will be understood that the implants, devices, instrumentation, systems and methods may be used with other bones and / or joints of the body having a similar structure.
[0020] Referring to the drawings, in which like reference numbers are used to indicate like or similar components throughout the several views, and with particular reference to FIGS. 1-12, one embodiment of an implant 100 is illustrated. The implant 100 may include a first side or top surface 102, a second side or bottom surface 104, a third side or right surface 106, a fourth side or left surface 108, a fifth side or first end surface 110, and a sixth side or second end surface 112. The first side 102 may extend generally parallel to the second side 104, for example. The third side 106 may extend generally parallel to the fourth side 108, for example. The fifth side 110 may extend generally parallel to the sixth side 112, for example. The implant 100 may also include an inner body 120 surrounded by a frame or housing 150.
[0021] 1-12, the inner body 120 can include an intermediate portion 122 that extends through the implant 100 from the first side 102 to the second side 104. The intermediate portion 122 can define a through hole 123 that extends through the inner body 120, as shown in FIGS. 1, 2, and 5-11. The inner body 120 can also include a first guide hole or first access opening 124 and a second guide hole or second access opening 126. The first guide hole 124 can be, for example, partially recessed into the first side 102 and the third side 106 of the implant 100 and extend through the implant 100 from the first side 102 to the second side 104 at at least one angle. Similarly, the second guide hole 126 may, for example, be partially recessed into the first side 102 and the fourth side 108 of the implant 100 and extend through the implant 100 from the first side to the second side 104 at at least one angle.
[0022] 1, 2, and 7-10, the first guide hole 124 can include at least a first upper portion 128, a first lower portion 132, and a second lower portion 134. As shown in FIGS. 1, 2, and 7-10, the second guide hole 126 can include at least a second upper portion 130, a third lower portion 136, and a fourth lower portion 138.
[0023] The at least one first upper portion 128 may be configured or sized and shaped, for example, to allow a fastener (not shown) to be inserted through the first upper portion 128 of the first guide hole 124 at two or more angles. For example, the two or more insertion angles may be at least one first angle forming at least one first path from the first upper portion 128 to the third lower portion 136 or at least one second angle forming at least one second path from the first upper portion 128 to the fourth lower portion 138.
[0024] The at least one second upper portion 130 may be configured or sized and shaped, for example, to allow a fastener (not shown) to be inserted through the second upper portion 130 of the second guide hole 126 at two or more angles. For example, the two or more angles may be at least one first angle forming at least one first path from the second upper portion 130 to the first lower portion 132 or at least one second angle forming at least one second path from the second upper portion 130 to the second lower portion 134.
[0025] 1, 9, and 10, the intermediate portion 122 of the inner body 120 may also include at least one first channel or slot 140 disposed on a first side of the intermediate portion 122 and at least one second channel or slot 142 disposed on a second side of the intermediate portion 122. The at least one first channel 140 may be disposed opposite the at least one second channel 142, for example. In addition, the first and second channels 140, 142 may be disposed between the first guide hole 124 and the second guide hole 126. The first channel 140 may be shaped, for example, such that a first portion near the first side 102 of the implant 100 has a smaller width than a second portion near the second side 104 of the implant 100. The second channel 142 may also be shaped, for example, such that a first portion near the first side 102 of the implant 100 has a smaller width than a second portion near the second side 104 of the implant 100. The first portions of the first and second channels 140, 142 may be, for example, generally rectangular or oval in shape, and the second portions of the first and second channels 140, 142 may be, for example, generally triangular in shape. The first portions of the channels 140, 142 extend into the second portions of the channels 140, 142.
[0026] The frame 150 may include supports 152, 154, 156, 158, 160, 162, 164 on the third side 106 of the implant 100, as shown in FIG. 6. The first support, first base or first linear member 152 may be disposed, for example, at the lower end of the third side 106, i.e., where the third side 106 engages the second side 104. The first arm, second linear member or second support 154 may extend from a first end of the first support 152, for example, perpendicular to the first support 152. The first arm 154 may be disposed, for example, where the third side 106 engages the fifth side 110. The second arm, third linear member or third support 156 may extend from a second end of the first support 152, for example, perpendicular to the first support 152. The fourth linear member or fourth support 158 may extend from the first end of the first arm 154 toward the first guide hole 124 of the middle portion 122. The fifth linear member or fifth support 160 may extend from the first end of the second arm 156 toward the first guide hole 124 of the middle portion 122. The first guide hole member or sixth support 162 may extend, for example, between the fourth linear member 158 and the fifth linear member 160. The first guide hole member 162 may be coupled to or integral with the outer surface of the first upper portion 128 of the first guide hole 124 of the middle portion 122, for example. The first guide hole member 162 may be curved, for example. The curved portion of the first guide hole member 162 may be a concave curved portion, for example. The third arm, sixth linear member, or seventh support 164 may be coupled at a first end to a middle portion of the first guide hole member 162 and at a second end to the first base 152. The third arm 164 may be coupled, for example, to a distal-most portion of the first guide hole member 162. The first arm 154, the second arm 156, and the third arm 164 may each extend parallel to one another, for example, as the arms 154, 156, 164 extend from the bottom surface 104 toward the top surface 102. The third side 106 may also include at least one first window 166 and at least one second window 168, as shown in FIGS. 2 and 6.At least one first window 166 may be disposed, for example, between a portion of the first base 152, the first arm 154, the fourth linear member 158, a portion of the first guide hole member 162, and the third arm 164. Thus, the first base 152, the first arm 154, the fourth linear member 158, a portion of the first guide hole member 162, and the third arm 164 provide an enclosure structure for forming at least one first window 166 extending through the third side surface 106. At least one second window 168 may be disposed, for example, between a portion of the first base 152, the second arm 156, the fifth linear member 160, a portion of the first guide hole member 162, and the third arm 164. Thus, the first base 152, the second arm 156, the fifth linear member 160, a portion of the first guide hole member 162, and the third arm 164 provide an enclosure structure for forming at least one second window 168 extending through the third side 106.
[0027] 5, the frame 150 may also include supports 170, 172, 174, 176, 178, 180, 182 on the fourth side 108 of the implant 100. The eighth support, second base or seventh linear member 170 may be disposed, for example, at the lower end of the fourth side 108, i.e., where the fourth side 108 engages the second side 104. The fourth arm, eighth linear member or ninth support 172 may extend from a first end of the eighth support 170, for example, perpendicular to the eighth support 170. The fourth arm 172 may be disposed, for example, where the fourth side 108 engages the fifth side 110. The fifth arm, ninth linear member or tenth support 174 may extend from a first end of the second base 170, for example, perpendicular to the second base 170. The tenth linear member or eleventh support 176 may extend from the first end of the fourth arm 172 toward the second guide hole 126 of the middle portion 122. The eleventh linear member or twelfth support 176 may extend from the first end of the fourth arm 172 toward the second guide hole 126 of the middle portion 122. The second guide hole member or thirteenth support 180 may extend, for example, between the tenth linear member 176 and the eleventh linear member 178. The second guide hole member 180 may be coupled to or integral with the outer surface of the second upper portion 130 of the second guide hole 126 of the middle portion 122, for example. The second guide hole member 180 may be curved, for example. The curved portion of the second guide hole member 180 may be a concave curved portion, for example. The sixth arm, twelfth linear member or fourteenth support 182 may be connected at a first end to a middle portion of the second guide hole member 180 and at a second end to the second base 170. The sixth arm 182 may be connected, for example, to a distal-most portion of the second guide hole member 180. The fourth arm 172, the fifth arm 174 and the sixth arm 182 may each extend parallel to one another, for example, as the arms 172, 174, 182 extend from the bottom surface 104 toward the top surface 102. The fourth side 108 may also include at least one third window 184 and at least one fourth window 186, as shown in FIGS. 1 and 5.At least one third window 184 may be disposed, for example, intermediately between a portion of the second base 170, the fourth arm 172, the tenth linear member 176, a portion of the second guide hole member 180, and the sixth arm 182. At least one fourth window 186 may be disposed, for example, intermediately between a portion of the second base 170, the fifth arm 174, the eleventh linear member 178, a portion of the second guide hole member 180, and the sixth arm 182.
[0028] 3, the frame 150 may include a first support member 190 on the fifth side 110 of the implant 100. The first support member 190 may include a first recessed area 192 extending from the fifth side 110 into a middle portion. The first recessed area 192 may have, for example, a length, a width, and a height, where the length may be greater than the height. The height may extend in a direction between the top surface 102 and the bottom surface 104, the length may extend in a direction between the third side 106 and the fourth side 108, and the width may extend in a direction between the first end surface 110 and the second end surface 112. The first support member 190 may also include a first through hole 194 extending through the first support member 190. The first through hole 194 may extend, for example, completely through the fifth side 110 of the implant 100. The first through hole 194 may, for example, include threads 196 on an inner surface. The first support member 190 may also include at least one fifth window, top window, or opening 198 extending through the first support member 190. The at least one fifth window 198 may, for example, include two parallel sides, a base portion connecting the two parallel sides at a first end, and a top portion connecting the two parallel sides at a second end. The top portion may, for example, be sloped as it extends between the two sides. The at least one fifth window 198 may, for example, be at least two windows 198 disposed on the inner and outer sides of the fifth side 110. As shown in the illustrated embodiment, the two fifth windows 198 may be disposed near the top end of the implant 100 such that they are mirror images of each other. The first support member 190 may also include at least one sixth window, lower window, or opening 200 extending through the first support member 190. The at least one sixth window 200 may include, for example, two parallel sides, a base portion connecting the two parallel sides, and a top portion connecting the two parallel sides. The base portion may be sloped, for example, as it extends between the two sides. The at least one sixth window 200 may be, for example, at least two windows 200 disposed on the inside and outside of the fifth side 110. As shown in the illustrated embodiment, the two sixth windows 200 may be disposed near the bottom end of the fifth side 110 of the implant 100 such that they are mirror images of each other.The first support member 190 may also include at least one seventh window, intermediate window or opening 202. The at least one seventh window 202 may be located, for example, adjacent to the first recessed region 192. In the illustrated embodiment, the at least one seventh window 202 is one seventh window 202 located below the recessed region 192, between the recessed region 192 and the bottom surface 104.
[0029] 4, the frame 150 may include a second support member 204 on the sixth side 112 of the implant 100. The second support member 204 may include a second recessed region 206 extending from the sixth side 112 into a middle portion. The second recessed region 206 may have, for example, a length, a width, and a height, where the length may be greater than the height. The height may extend in a direction between the top surface 102 and the bottom surface 104, the length may extend in a direction between the third side 106 and the fourth side 108, and the width may extend in a direction between the first end surface 110 and the second end surface 112. The second support member 204 may also include a second through hole 208 extending through the second support member 204. The second through hole 208 may extend completely through the sixth side 112 of the implant 100, for example. The second through hole 208 may include, for example, a thread 210 disposed on an inner surface of the second through hole 208. The second support member 204 may also include at least one eighth window, top window, or opening 212 extending through the second support member 204. The at least one eighth window 212 may include, for example, two parallel sides, a base portion connecting the two parallel sides at a first end, and a top portion connecting the two parallel sides at a second end. The top portion may be sloped, for example, as it extends between the two sides. The at least one eighth window 212 may be, for example, at least two windows 212 disposed on the inside and outside of the sixth side 112. As shown in the illustrated embodiment, the two eighth windows 212 may be disposed near the top end of the implant 100 such that they are mirror images of each other. The second support member 204 may also include at least one ninth window, bottom window, or opening 214 extending through the second support member 204. The at least one ninth window 214 may include, for example, two parallel sides, a base portion connecting the two parallel sides, and a top portion connecting the two parallel sides. The base portion may be sloped, for example, as it extends between the two sides. The at least one ninth window 214 may be, for example, at least two windows 214 disposed on the inside and outside of the sixth side 112.As shown in the illustrated embodiment, two ninth windows 214 may be located near the bottom end of the sixth side 112 of the implant 100 to be mirror images of one another. The second support member 204 may also include at least one tenth window, intermediate window or opening 216. The at least one tenth window 216 may be located adjacent to the second recessed region 206, for example. In the illustrated embodiment, the at least one tenth window 216 is one tenth window 216 located below the second recessed region 206, between the second recessed region 206 and the bottom surface 104, for example.
[0030] 1, 7, 8, and 10, the frame 150 may also include a first or internal protrusion 218 extending away from the inner surface of the fifth side 110. The first protrusion 218 may be located, for example, intermediate the third side 106 and the fourth side 108. The top surface of the first protrusion 218 may be sloped as the top surface extends from the first side 102 toward the second side 104, for example, as shown in FIGS. 1 and 10. The bottom surface of the first protrusion 218 may also be sloped as the bottom surface extends from the second side 104 toward the first side 102. A first through hole 194 may extend through the first protrusion 218.
[0031] 2, 7, 8, and 10, the frame 150 may include a second or internal protrusion 220 extending away from the inner surface of the sixth side 112. The second protrusion 220 may be located, for example, midway between the third side 106 and the fourth side 108. The top surface of the second protrusion 220 may be sloped as the top surface extends from the first side 102 toward the second side 104, for example, as shown in FIGS. 2 and 10. The bottom surface of the second protrusion 220 may also be sloped as the bottom surface extends from the second side 104 toward the first side 102. The second through hole 208 may extend through the second protrusion 220.
[0032] 1, 2, and 7-11, the implant 100 may also include a first passageway 222 extending between the frame 150 and the inner body 120 near the first end surface 110. The first passageway 222 opens from the first side surface 102 to the second side surface 104. The first through hole 194 and openings 198, 200, 202 extend from the outer surface of the frame 150 to the passageway 222. The implant 100 may further include a second passageway 224 extending between the frame 150 and the inner body 120 near the second end surface 112. The second passageway 224 opens from the first side surface 102 to the second side surface 104. The second through hole 208 and openings 212, 214, 216 extend from the outer surface of the frame 150 to the passageway 224.
[0033] As shown in Figures 11 and 12, the implant 100 may also include a lattice structure 230 disposed within the openings 166, 168, 184, 186, 198, 200, 202, 212, 214, 216, 222, 224 of the implant 100. The lattice structure 230 may be disposed within the first and second passages 222, 224, for example, to aid in bone fusion. The lattice structure 230 may include a plurality of recessed areas or grooves 232 between a plurality of raised portions 234, for example, as shown enlarged in Figure 12. Alternatively, the lattice structure may be printed within the passages 222, 224, for example. The lattice structure may be, for example, a non-nodal randomized web-based matrix. The lattice structure matrix may have a pore size of, for example, about 4 mm to about 5 mm. The lattice structure may include, for example, rough elements extending between structures forming the passages 222, 224. The lattice structure 230 may be offset from the outer frame, for example, by about 0.5 mm to the inside of the frame, so that the frame of the implant 100 is the only bone-contacting element after implantation, and the lattice structure 230 does not directly contact the bone.
[0034] 13-23, another implant 250 is shown. The implant 250 can include a first side or top surface 252, a second side or bottom surface 254, a third side or right surface 256, a fourth side or left surface 258, a fifth side or first end surface 260, and a sixth side or second end surface 262. The second side surface 254 can be inclined with respect to the first side surface 252, for example, when the first and second sides 252, 254 extend between the first end surface 260 and the second end surface 262. The third side surface 256 can extend, for example, generally parallel to the fourth side surface 258. The fifth side surface 260 can extend, for example, generally parallel to the sixth side surface 262. The height of the fifth side surface 260 is less than the height of the sixth side surface 262, for example. The height may be measured between the top surface 252 and the bottom surface 254. The implant 250 may also include an inner body 270 surrounded by a frame or housing 300.
[0035] 13-23, the inner body 270 can include an intermediate portion 272 that extends through the implant 250 from the first side 252 to the second side 254. The intermediate portion 272 can define a through hole 273 that extends through the inner body 270, as shown in FIGS. 13, 14, and 17-23. The inner body 270 can also include a first guide hole or first access opening 274 and a second guide hole or second access opening 276. The first guide hole 274 can be, for example, partially recessed into the first side 252 and the third side 256 of the implant 250 and extend through the implant 250 from the first side 252 to the second side 254 at at least one angle. Similarly, the second guide hole 276 may, for example, be partially recessed into the first side 252 and the fourth side 258 of the implant 250 and extend through the implant 250 from the first side 252 to the second side 254 at at least one angle.
[0036] 1, 2, and 7-10, the first guide hole or access opening 274 may include at least a first upper portion 278, a first lower portion 282, and a second lower portion 284. The second lower portion 284 may also include a first recess 285, for example, recessed into the second lower portion 284 from the bottom surface 254. As shown in FIG. 1, 2, and 7-10, the second guide hole or access opening 276 may include at least a second upper portion 280, a third lower portion 286, and a fourth lower portion 288. The fourth lower portion 288 may also include a second recess 289, for example, recessed into the fourth lower portion 288 from the bottom surface 254.
[0037] The at least one first upper portion 278 may be configured or sized and shaped, for example, to allow a fastener (not shown) to be inserted through the first upper portion 278 of the first guide hole 274 at two or more angles. For example, the two or more angles may be at least one first angle forming at least one first path from the first upper portion 278 to the third lower portion 286 or at least one second angle forming at least one second path from the first upper portion 278 to the fourth lower portion 288.
[0038] The at least one second upper portion 280 can be configured or sized and shaped, for example, to allow a fastener (not shown) to be inserted through the second upper portion 280 of the second guide hole 276 at two or more angles. For example, the two or more angles can be at least one first angle forming at least one first path from the second upper portion 280 to the first lower portion 282 or at least one second angle forming at least one second path from the second upper portion 280 to the second lower portion 284.
[0039] 1, 9, and 10, the intermediate portion 272 of the inner body 270 may also include at least one first channel or slot 290 disposed on a first side of the intermediate portion 272 and at least one second channel or slot 292 disposed on a second side of the intermediate portion 272. The at least one first channel 290 may be disposed opposite the at least one second channel 292, for example. In addition, the first and second channels 290, 292 may be disposed between the first guide hole 274 and the second guide hole 276. The first channel 290 may be shaped, for example, such that a first portion near the first side 252 of the implant 250 has a smaller width than a second portion near the second side 254 of the implant 250. The second channel 292 may also be shaped, for example, such that a first portion near the first side 252 of the implant 250 has a smaller width than a second portion near the second side 254 of the implant 250. The first portions of the first and second channels 290, 292 may be, for example, generally rectangular or oval in shape, and the second portions of the first and second channels 290, 292 may be, for example, generally triangular in shape. The first portions of the channels 290, 292 extend into the second portions of the channels 290, 292.
[0040] The frame 300 may include supports 302, 304, 306, 308, 310, 312, 314 on the third side 256 of the implant 250, as shown in FIG. 17. The first support, first base or first linear member 302 may be disposed, for example, at the lower end of the third side 256, i.e., where the third side 256 engages the second side 254. The first arm, second linear member or second support 304 may extend from a first end of the first support 302. The first arm 304 may be disposed, for example, where the third side 256 engages the fifth side 260. The second arm, third linear member or third support 306 may extend from a second end of the first support 302. The fist arm 304 may be disposed parallel to the second arm 306, for example, as the arms 304, 306 extend from the first support 302 toward the top surface 252 of the implant 250. The fourth linear member or fourth support member 308 may extend from the first end of the first arm 304 toward the first guide hole 274 of the middle portion 272. The fifth linear member or fifth support 310 may extend from the first end of the second arm 306 toward the first guide hole 274 of the middle portion 272. The first guide hole member or sixth support 312 may extend between the fourth linear member 308 and the fifth linear member 310, for example. The first guide hole member 312 may be coupled to or integral with an outer surface of the first top portion 278 of the first guide hole 274 of the middle portion 272, for example. The first guide hole member 312 may be curved, for example. The curved portion of the first guide hole member 312 may be a concave curved portion, for example. The third arm, sixth linear member, or seventh support 314 may be connected at a first end to a middle portion of the first guide hole member 312 and at a second end to the first base 302. The first arm 304, the second arm 306, and the third arm 314 may each extend, for example, parallel to each other. The third side 256 may also include at least one first window 316 and at least one second window 318, as shown in FIG. 14 and FIG. 17.At least one first window 316 may be disposed, for example, intermediately between a portion of the first base 302, the first arm 304, the fourth linear member 308, a portion of the first guide hole member 312, and the third arm 314. At least one second window 318 may be disposed, for example, intermediately between a portion of the first base 302, the second arm 306, the fifth linear member 310, a portion of the first guide hole member 312, and the third arm 314.
[0041] 18, the frame 300 may also include supports 320, 322, 324, 326, 328, 330, 332 on the fourth side 258 of the implant 250. The eighth support, second base or seventh linear member 320 may be disposed, for example, at the lower end of the fourth side 258, i.e., where the fourth side 258 engages the second side 254. The second base 320 may be sloped, for example, between the first end surface 260 and the second end surface 262. The fourth arm, eighth linear member or ninth support 322 may extend from the first end of the second base 320. The fourth arm 322 may be disposed, for example, where the fourth side 258 engages the fifth side 260. The fifth arm, ninth linear member or tenth support 324 may extend from the second end of the second base 320. The tenth linear member or fourth support 326 may extend from the first end of the fourth arm 322 toward the second guide hole 276 of the middle portion 272. The eleventh linear member or twelfth support 328 may extend from the first end of the fifth arm 324 toward the second guide hole 276 of the middle portion 272. The second guide hole member or thirteenth support 330 may extend, for example, between the tenth linear member 326 and the eleventh linear member 328. The second guide hole member 330 may be coupled to or integral with the outer surface of the second upper portion 280 of the second guide hole 276 of the middle portion 272, for example. The second guide hole member 330 may be curved, for example. The curved portion of the second guide hole member 330 may be, for example, a concave curved portion. The sixth arm, the twelfth linear member, or the fourteenth support 332 may be connected at a first end to a middle portion of the second guide hole member 330 and at a second end to the second base 320. The fourth arm 322, the fifth arm 324, and the sixth arm 332 may extend, for example, parallel to each other. The fourth side 258 may also include at least one third window 334 and at least one fourth window 336, as shown in FIG. 13 and FIG. 18. The at least one third window 334 may be disposed, for example, intermediate between a portion of the second base 320, the fourth arm 322, the tenth linear member 326, a portion of the second guide hole member 330, and the sixth arm 332.At least one fourth window 336 can be disposed, for example, intermediate a portion of the second base 320, the fifth arm 324, the eleventh linear member 328, a portion of the second guide hole member 330, and the sixth arm 332.
[0042] 15, the frame 300 may include a first support member 340 on the fifth side 260 of the implant 250. The first support member 340 may include a first recessed area 192 extending from the fifth side 260 into a middle portion. The first recessed area 192 may be as described in more detail above with respect to the implant 100. The first support member 340 may also include a first through hole 194 extending therethrough. The first through hole 194 may, for example, extend completely through the fifth side 260 of the implant 250. The first through hole 194 may include, for example, a thread 196. The first support member 340 may also include at least one fifth window, upper window, or opening 198 extending therethrough. The at least one fifth window 198 may include, for example, two parallel sides, a base portion connecting the two parallel sides at a first end, and a top portion connecting the two parallel sides at a second end. The base portion may be inclined, for example, as it extends between the two sides. The at least one fifth window 198 may be, for example, at least two windows 198 disposed on the inside and outside of the fifth side 260. As shown in the illustrated embodiment, the two fifth windows 198 may be disposed near the top end of the implant 250 such that they are mirror images of each other. The first support member 340 may also include at least one sixth window, lower window, or opening 200 extending through the first support member 340. The at least one sixth window 200 may include, for example, two parallel sides, a base portion connecting the two parallel sides, and a top portion connecting the two parallel sides. The base portion may be, for example, sloped as it extends between the two sides. The at least one sixth window 200 may be, for example, at least two windows 200 disposed on the inside and outside of the fifth side 260. As shown in the illustrated embodiment, the two sixth windows 200 may be disposed near the bottom end of the fifth side 260 of the implant 250 such that they are mirror images of each other. The first support member 340 may also include at least one seventh window, intermediate window or opening 202. The at least one seventh window 202 may be disposed adjacent the first recessed region 192, for example.In the illustrated embodiment, the at least one seventh window 202 is one seventh window 202 disposed below the recessed area 192 .
[0043] 16, the frame 300 may include a second support member 342 on the sixth side 262 of the implant 250. The second support member 342 may include a second recessed area 206 extending from the sixth side 262 into a middle portion. The second recessed area 206 may have, for example, a length, a width and a height, and the length may be greater than the height. The second support member 342 may also include a second through hole 208 extending through the second support member 342. The second through hole 208 may, for example, extend completely through the sixth side 262 of the implant 250. The second through hole 208 may include, for example, a thread 210. The second support member 342 may also include at least one eighth window, upper window, or opening 212 extending through the second support member 342. The at least one eighth window 212 may include, for example, two parallel sides, a base portion connecting the two parallel sides at a first end, and a top portion connecting the two parallel sides at a second end. The base portion may be inclined, for example, as it extends between the two sides. The at least one eighth window 212 may be, for example, at least two windows 212 disposed on the inside and outside of the sixth side 262. As shown in the illustrated embodiment, the two eighth windows 212 may be disposed near the top end of the implant 250 such that they are mirror images of each other. The second support member 342 may also include at least one ninth window, lower window, or opening 214 extending through the second support member 342. The at least one ninth window 214 may include, for example, two parallel sides, a base portion connecting the two parallel sides, and a top portion connecting the two parallel sides. The base portion may be, for example, sloped as it extends between the two sides. The at least one ninth window 214 may be, for example, at least two windows 214 disposed on the inner and outer sides of the sixth side 262. As shown in the illustrated embodiment, the two ninth windows 214 may be disposed near the bottom end of the sixth side 262 of the implant 250 such that they are mirror images of each other. The second support member 342 may also include at least one tenth window, intermediate window or opening 216. The at least one tenth window 216 may be disposed adjacent the second recessed region 206, for example.In the illustrated embodiment, the at least one tenth window 216 is, for example, one tenth window 216 disposed below the second recessed area 206 .
[0044] 14, 19, 20, and 23, the frame 300 may also include a first or internal protrusion 218 extending away from the inner surface of the fifth side 252. The first protrusion 218 may be disposed, for example, intermediate the third side 256 and the fourth side 258. The top surface of the first protrusion 218 may be sloped, for example, as the top surface extends between the first side 252 and the second side 254, as shown in FIG. 23. The bottom surface of the first protrusion 218 may also be sloped, for example, as the bottom surface extends between the second side 254 and the first side 252. A first through hole 194 may extend through the first protrusion 218.
[0045] 13, 19, 20, and 23, the frame 300 may include a second or internal protrusion 220 extending away from the inner surface of the sixth side 262. The second protrusion 220 may be disposed, for example, midway between the third side 256 and the fourth side 258. The top surface of the second protrusion 220 may be sloped, for example, as the top surface extends between the first side 252 and the second side 254, as shown in FIGS. 13 and 23. The bottom surface of the second protrusion 220 may also be sloped, for example, as the bottom surface extends between the second side 254 and the first side 252. The second through hole 208 may extend through the second protrusion 220.
[0046] 13, 14, and 19-23, the implant 250 may also include a first passageway 222 extending between the frame 300 and the inner body 270 near the first end surface 260. The first passageway 222 opens from the first side surface 252 to the second side surface 254. The first through hole 194 and openings 198, 200, 202 extend from the outer surface of the frame 300 to the passageway 222. The implant 250 may further include a second passageway 224 extending between the frame 300 and the inner body 270 near the second end surface 254. The second passageway 224 opens from the first side surface 252 to the second side surface 254. The second through hole 208 and openings 212, 214, 216 extend from the outer surface of the frame 300 to the passageway 224.
[0047] The implant 250 may also include a lattice structure 230, as shown in Figures 11 and 12. The lattice structure 230 may be disposed, for example, in the openings 316, 318, 334, 336, 198, 200, 202, 212, 214, 216, 222, 224 of the implant 250. The lattice structure 230 may be disposed, for example, in the first and second passages 222, 224 to aid in bone fusion. As described above in more detail with respect to Figure 12, but not described again here for brevity, the lattice structure 230 may include, for example, a plurality of recessed areas or grooves 232 between a plurality of raised portions 234, or alternatively may be printed, for example, in the passages 222, 224. The lattice structure 230 may be offset, for example, from the outer frame of the implant 250. The lattice structure 230 may be offset by about 0.5 mm to the inside of the frame of the implant 250. Thus, the frame of the implant 250 is the only bone-contacting element once implanted; the lattice structure 230 does not directly contact the bone.
[0048] 24-34, another implant 350 is shown. The implant 350 can include a first side or top surface 352, a second side or bottom surface 354, a third side or right surface 356, a fourth side or left surface 358, a fifth side or first end surface 360, and a sixth side or second end surface 362. The first side 352 and the second side 354 can each be curved in opposite directions, for example, to give the implant 350 a generally cylindrical or bullet shape. The third side 356 can extend generally parallel to the fourth side 358, for example. The fifth side 360 can extend generally parallel to the sixth side 362, for example. The fifth side 360 and the sixth side 362 may have, for example, a round, circular, circular or disk shape, and the diameter of the fifth side 360 may be greater than the diameter of the sixth side 362. The implant 350 may also include an inner body 370 surrounded by or disposed within the frame or housing 410.
[0049] The inner body 370 can include an intermediate portion 372 that extends through the implant 350 from the first side 352 to the second side 354, as shown in Figures 24, 25, and 28-34. The intermediate portion 372 can define a through hole 374 that extends through the inner body 370, as shown in Figures 24, 25, 30, and 31. The inner body 370 can also include a first guide hole or first access opening 376 and a second guide hole or second access opening 378. The first guide hole 376 can be angled, for example, in a first direction, and the second guide hole 378 can be angled, for example, in a second direction. The first and second directions can include tracks that extend in opposite directions. The trajectories of the first guide hole 376 and the second guide hole 378 may overlap as the trajectories extend through the implant 350 from the first side 352 to the second side 354 .
[0050] 24-34, the first guide hole 376 may include a first support member 380 coupled to the middle portion 372 and extending away from the middle portion 372. The first support member 380 may be, for example, circular or rounded in shape. As shown in FIGS. 27-28, the first support member 380 may be, for example, curved as it extends away from the middle portion 372. The first guide hole 376 may also include a recessed area 384 and a first lower portion 388. The first lower portion 388 may, for example, extend away from the middle portion 372 and may have a semicircular shape. The first lower portion 388 may, for example, be tapered from a proximal-most attachment point to its free end. The first lower portion 388 may, for example, be disposed on a second side of the middle portion 372. The recessed area 384 may extend into the middle portion 372 on a first side. The recessed area 384 may extend downwardly, for example, to a point that allows a fastener (not shown) inserted into an opening formed by the first support member 380 to travel on a track between the opening formed by the first support member 380 and a recess formed by the first lower portion 388.
[0051] The second guide hole 378 may include a second support member 382 coupled to the middle portion 372 and extending away from the middle portion 372. The second support member 382 may be, for example, circular, or rounded in shape. As shown in FIG. 27 and FIG. 29, the second support member 382 may be, for example, curved as it extends away from the middle portion 372. The second guide hole 378 may also include a recessed area 386 and a second lower portion 390. The second lower portion 390 may, for example, extend away from the middle portion 372 and may have a semicircular shape. The second lower portion 390 may, for example, be tapered from the proximal-most attachment point to its free end. The second lower portion 390 may be disposed on, for example, a first side of the middle portion 372. The recessed area 386 may extend into the middle portion 372 on a second side of the middle portion 372. The recessed area 386 may extend downwardly, for example, to a point that allows a fastener (not shown) inserted into an opening formed by the second support member 382 to move on a track between the opening formed by the second support member 382 and a recess formed by the second lower portion 390.
[0052] 24-29, 32 and 33, the middle portion 372 of the inner body 370 may also include a first portion 392 and a second portion 394 extending between the first arm member 380 and the second lower portion 390 on one side and between the second arm member 382 and the first lower portion 388 on the other side. The middle portion 372 may also include at least one first channel or slot 396, 398 disposed on the first side 392 of the middle portion 372 and at least one second channel or slot 400 disposed on the second side 394 of the middle portion 372. The at least one first channel 396, 398 may be disposed on an opposite side of the at least one second channel 400, for example. In addition, the first and second channels 396, 398, 400 may be disposed between the first support member 380 and the second support member 382.
[0053] As shown in FIG. 33, the at least one first channel 396, 398 may include at least one first proximal channel 396 and at least one first distal channel 398. The first proximal channel 396 may be shaped, for example, as one of a rectangle, an oval, or a rectangle with rounded edges. The first distal channel 398 may be shaped, for example, as a generally triangular shape with straight or curved sides and sharp or flat corners. As shown in FIG. 32, the second channel 400 may be shaped, for example, such that a first portion disposed near the top or bottom surface 352, 354 of the implant 350 has a smaller width than a second portion near the midpoint of the implant 350. The second channel 400 may have, for example, a first end and an opposite second end, and a first side and a second side extending from a free end of the second side toward the first side. The second channel 400 may also include a third side extending between a first side of the end not connected to the second end and a free end of the first end. The third side may be curved, for example, as the third side extends between the first side and the first end. The second channel 400 may further include a fourth side extending between a second side of the end not connected to the second end and a free end of the first side opposite the third side. The fourth side may be curved, for example, as the fourth side extends between the second side and the first end.
[0054] 24-34, the frame 410 may include a first base or first support 412 disposed on a first end surface of the frame 410 and a second base or fifth support 434 disposed on a second end surface of the frame 410. The first support 412 may be, for example, a circular or oval shaped ring having an outer surface, an inner surface, a first end surface or outer surface, and a second end surface or inner surface. The frame 410 may also include a second support or cross member 414 having a first end surface and a second end surface. The first and second ends of the second support 414 are connected to the inner surface of the first base 412, for example, near the midpoint between the top surface 352 and the bottom surface 354 of the implant 350. The second support 414 may include a first portion 416, a second portion 418, and a connecting portion 420. The first portion 416 is coupled to the inner surface of the first base 412 on the third side 356 of the implant 350 and extends from the inner surface of the first base 412 toward the midpoint, and the second portion 418 is coupled to the inner surface of the first base 412 on the fourth side 358 and extends from the inner surface of the first base 412 toward the midpoint. The first portion 416 is coupled to the second portion 418 by a coupling portion 420 disposed, for example, at the midpoint of the first base 412. The coupling portion 420 may have, for example, a height in a direction between the top surface 352 and the bottom surface 354 that is greater than the height of each of the first portion 416 and the second portion 418. The first base 412 and the second support 414 may have, for example, the same width in a direction between the first end surface 360 and the second end surface 362.
[0055] The connecting portion 420 may also include a recessed area 422 recessed within the connecting portion 420 from the first end surface 360 toward the inner surface of the first base 412, as shown in FIGS. 24, 26, and 34. Additionally, the connecting portion 420 may include a through hole 424 extending through the connecting portion 420 from the first end surface 360 toward the inner surface of the first base 412. The through hole 424 may be centered, for example, on the recessed area 422. Thus, the through hole 424 may overlap the recessed area 422 in the connecting portion 420. The first base 412 may also include a first opening 426 and a second opening 428 extending through the first base 412 from the first end surface 360 toward the second end surface 362. The first opening 426 may, for example, be disposed above the second portion 418, and the second opening 428 may, for example, be disposed below the second portion 418. The first and second openings 426, 428 may, for example, be mirror images of each other.
[0056] The first base 412 is connected to the second base 434 by a third support or first arm 430 and a fourth support or second arm 432. The first arm 430 may be disposed on a first side and the second arm 432 may be disposed on a second side opposite the first side. The first arm 430 may be disposed on a left side 356 of the implant 350, for example, and the second arm 432 may be disposed on a right side 358 of the implant 350. The first arm 430 is disposed opposite and parallel to the second arm 432. The second base 434 may have a round or circular cross-sectional shape, for example. The first and second arms 430, 432 may be connected to the second base 434 near the midline of the second base 434.
[0057] The implant 350 may also include a lattice structure 230, as shown in Figures 11 and 12. The lattice structure 230 may be disposed, for example, in an opening between the inner body 370 and the housing 410. The lattice structure 230 may be disposed, for example, in a space between the inner body 370 and the housing 410 to aid in bone fusion. As described above in more detail with respect to Figure 12, and not described again here for brevity, the lattice structure 230 may include, for example, a plurality of recessed areas or grooves 232 between a plurality of raised portions 234, or alternatively, may be printed, for example, in the opening between the inner body 370 and the housing 410. The lattice structure 230 may be offset, for example, from the outer frame of the implant 350. The lattice structure 230 may be offset about 0.5 mm inward of the frame of the implant 350. Thus, the frame of the implant 350 is the only bone-contacting element after implantation, and the lattice structure 230 does not directly contact the bone.
[0058] 35-45, another implant 450 is shown. The implant 450 may include a first side or top surface 452, a second side or bottom surface 454, a third side or right surface 456, a fourth side or left surface 458, a fifth side or first end surface 460, and a sixth side or second end surface 462. The first side 452 and the second side 454 may each be curved in opposite directions, for example, to give the implant 350 a generally circular or ball shape. The third side 456 and the fourth side 458 may also each be curved in opposite directions, for example. Additionally, the fifth side 460 and the sixth side 462 may also each be curved in opposite directions, for example. The implant 450 may also include an inner body 370 surrounded by or disposed within a frame or housing 470. Inner body 370 may be as described in more detail above with respect to implant 350, and will not be described again here for the sake of brevity.
[0059] 35 to 45, the housing 470 may include a plurality of coupling portions 472 and a plurality of support arms 482, 484, 486, 488 coupled to the coupling portions 472 and connecting the coupling portions 472. The coupling portions 472 may be disposed, for example, on the third side 456, the fourth side 458, the fifth side 460, and the sixth side 462. The coupling portion 472 disposed on the third side 456 faces the coupling portion 472 disposed on the fourth side 458. The coupling portion 472 disposed on the fifth side 460 faces the coupling portion 472 disposed on the sixth side 462. The first support arm 482 may extend between the coupling portion 472 on the fifth side 460 and the coupling portion 472 on the third side 456 and connect them. The second support arm 484 may extend between and connect the connecting portion 472 of the third side 456 and the connecting portion 472 of the sixth side 462. The third support arm 486 may extend between and connect the connecting portion 472 of the sixth side 462 and the connecting portion 472 of the fourth side 458. Finally, the fourth support arm 488 may extend between and connect the connecting portion 472 of the fourth side 458 and the connecting portion 472 of the fifth side 460.
[0060] The connecting portion 472 of the housing 470 and the arms 482, 484, 486, 488 together form a ring around the inner body 370. The housing 470 can be coupled to at least a portion of the inner body 370, for example. For example, the first arm member 380 can be coupled to a top of the connecting portion 472 disposed on the third side 456 of the implant 450. The second arm member 382 can be coupled to a top of the connecting portion 472 disposed on the fourth side 458 of the implant 450, for example. The connecting portion 472 can have a first height extending in a direction between the first side 452 and the second side 454 and a first width extending from the outer surface to the inner surface. The arms 482, 484, 486, 488 can have a second height extending in a direction between the first side 452 and the second side 454 and a second width extending from the outer surface to the inner surface. The first height of the connecting portion 472 can be, for example, greater than the second height of the arms 482, 484, 486, 488. The first width of the connecting portion 472 can be, for example, the same as or greater than the second width of the arms 482, 484, 486, 488.
[0061] Each of the connecting portions 472 may also include a recessed area 474 recessed within the connecting portion 472 from the first end surface 460 toward the inner surface of the housing 470. Additionally, the connecting portions 472 may also include a through hole 476 extending through each connecting portion 472 from the first end surface 460 toward the inner surface of the housing 470. The through hole 476 may be centered about the recessed area 474, for example. Thus, the through hole 476 may overlap the recessed area 474 at the connecting portion 472. The implant 450 may also include a first opening 478 extending between the inner body 370 and the housing 470 on a first side of the implant 450, and a second opening 480 extending between the inner body 370 and the housing 470 on a second side of the implant 450. The openings 478, 480 allow for the insertion of graft material to aid in fixation of the implant 450 to the patient's ankle bone.
[0062] The implant 450 may also include a lattice structure 230, as shown in Figures 12 and 45. The lattice structure 230 may be disposed, for example, in the openings 478, 480 between the inner body 370 and the housing 470. The lattice structure 230 may be disposed, for example, in the space between the inner body 370 and the housing 470 to aid in bone fusion. As described above in more detail with respect to Figure 12, and not described again here for brevity, the lattice structure 230 may include, for example, recessed areas or grooves 232 between the raised portions 234, or alternatively may be printed, for example, in the openings 478, 480 between the inner body 370 and the housing 470. The lattice structure 230 may be offset, for example, from the outer frame of the implant 450. The lattice structure 230 may be offset about 0.5 mm to the inside of the frame of the implant 450. Thus, the frame of the implant 450 is the only bone-contacting element once implanted; the lattice structure 230 does not directly contact the bone.
[0063] 46-51, a reaming tool 500 is shown. The reaming tool 500 may include a reaming head 502 and a reamer driver (not shown). The reamer driver may optionally include a tissue protector (not shown). The reaming head 502 may be attached to the reamer driver by a ball detent, such as the ball detent 530 shown in FIGS. 48-49. The reaming head 502 may have, for example, a hemispherical shape, a convex shape, or a shape corresponding to the shape of a spherical or cylindrical cage or implant, such as the implant 350, 450. The reaming head 502 may include an outer engagement surface or exterior surface 504 of the reaming head 502 and an inner surface 512 opposite the engagement surface 504. The engagement surface 504 may include a plurality of openings 506 spaced apart on the engagement surface 504. In some embodiments, the plurality of openings 506 may be evenly or uniformly spaced across the engagement surface 504, for example, while in other embodiments, the openings 506 may be spaced across only a portion of the engagement surface 504. The openings 506 may extend from the outer surface 504 through the reaming head 502 to the inner surface 512. Each of the openings 506 of the plurality of openings 506 may include an edge or portion 508, which may be, for example, a cutting edge or portion or a sharp edge or portion. The reaming head 502 may also include at least one guidewire or k-wire opening 510 that extends through the reaming head 502 from the outer surface 504 to the inner surface 512. The inner surface 512 may also have, for example, a hemispherical shape that corresponds to the shape of the engagement surface 504. Thus, the inner surface 512 may form a cavity or recess having, for example, a concave shape. The inner surface 512 may terminate in a rim 515 that connects the engagement surface 504 to the inner surface 512 at the end of the reaming head 502.
[0064] 46-51, the reaming head 502 may also include an engagement or coupling member 516 that extends from one side of the reaming head 502 to another side. The engagement member 516 may, for example, be coupled to a first portion of the inner surface 512 at a rim 515 on one side and to a second portion of the inner surface 512 at a rim 515 on the opposite side to position the engagement member 516 extending across the cavity 514 of the inner surface 512. The engagement member 516 may include a first support arm 518 that extends from the first side toward the second side of the inner surface 512, and a second support arm 520 that extends from the second side of the inner surface 512 toward the first side. The first support arm 518 may be coupled to the second support arm 520 by a coupling member 522. The first and second support arms 518, 520 can have various widths, for example, from the inner surface 512 of the reaming head 502 to the connecting member 522. For example, the sides of the arms 518, 520 can each have a concave curvature as the arms 518, 520 extend between the inner surface 512 and the connecting member 522. The connecting member 522 can include a first side 524, a second side 526, and a through hole 528 extending between the first side 524 and the second side 526. Both the first side 524 and the second side 526 extend between and connect the first support arm 518 and the second support arm 520.
[0065] 48-49, the ball detent 530 includes a housing 532 with a protrusion 534 extending away from a portion of the housing 532. The protrusion 534 engages the coupling member 522 of the reaming head 502. In addition, the housing 532 includes at least one opening 536 for receiving at least one spring 538. The at least one opening 536 is positioned to align the at least one opening 536 with at least one of the first side 524 and the second side 526 of the coupling member 522. The at least one spring 538 is depressed when the ball detent 530 is inserted into the through hole 528 of the coupling member 522 and exerts a force on one of the first side 524 and the second side 526 to couple the reaming head 502 and the ball detent 530. The ball detent 530 also includes a cannula 540 that extends through the ball detent 530 from the first end to the second end. The ball detent 530 is inserted to align the cannula 540 with a guidewire opening 510 in the reaming head 502. The cannula 540 and opening 510 allow a guidewire or k-wire to be inserted through the reaming instrument 500 and into the bone to be reamed. The ball detent 530 may also include a lead-in or tapered region 542 disposed at the second end. The tapered region 542 extends from the majority diameter of the cannula 540 to a wider diameter at the second end of the ball detent 530.
[0066] 52-60, an insertion tool 550 is shown. The insertion tool 550 includes a handle 556, a shaft 558 coupled to the handle 556, and an inner shaft 590 rotatably received within the shaft 558. The handle 556 is disposed at a first end 552 of the insertion tool 550. The handle 556 can include an opening 557 extending through at least a portion of the handle 556 for receiving and coupling the shaft 558 to the handle 556. The shaft 558 can include a first portion 560, a knob housing 562, and a second portion 566. The first portion 560 is disposed at a first end of the shaft 558 and couples to the handle 556, extending from the handle 556 to a second end 554 of the insertion tool 550. The knob housing 562 is coupled to the first portion 560 at a first end of the knob housing 562 and to the second portion 566 at a second end. The knob housing 562 includes an opening 564 that extends through the knob housing 562 from a first side to a second side. The knob housing 562 includes a width and a height. The width and height of the knob housing 562 can be greater than the diameters of the first and second portions 560, 566 of the shaft 558, for example. The opening 564 can be sized and shaped to accommodate the knob 584, for example. The second portion 566 extends from the second end of the knob housing 562 toward the second end 554 of the insertion instrument 550. The second portion 566 can include at least one through hole 568 extending therethrough in a direction perpendicular to a longitudinal axis of the shaft 558 extending between the first end 552 and the second end 554 of the insertion instrument 550. The at least one through hole 568 can be aligned with the longest portion of the handle 556, for example. The at least one through hole 568 can be, for example, two through holes 568, although alternative numbers of through holes 568 are contemplated. It is also contemplated that the through holes 568 can be positioned to extend through the second portion 566 in any orientation, for example.
[0067] 52-60, the second portion 566 also includes a precision guide mounting portion 570. The mounting portion 570 may include an engagement or mounting surface 572 for engaging a precision guide, such as the precision guide 600. The mounting portion 570 may also include a first protrusion 574 at a first end of the engagement surface 572 and a second protrusion 576 at a second end of the engagement surface 572. The first and second protrusions 574, 576 may extend circumferentially away from the second portion 566 of the shaft 558. The first and second protrusions 574, 576 aid in retaining the precision guide 600 in a desired position along the shaft 558 of the insertion instrument 550. The mounting portion 570 also includes a bore 578 extending into the engagement surface 572. The bore 578 may extend through at least a portion of the second portion 566 to one side of the engagement surface 572. The second portion 566 can also include at least one recessed region 580 at the second end of the shaft 558. The at least one recessed region 580 can be, for example, two recessed regions 580 disposed on opposite sides of the second portion 566. The at least one recessed region 580 can be, for example, tapered, curved, or arched, extending from a location offset from the second end 554 of the insertion instrument 550 to the second end of the second portion 566.
[0068] In addition, the shaft 558 may include a passageway 582 extending from the second end of the second portion 566 of the shaft 558 to the opening 564 of the knob housing 562. The passageway 582 may be sized and shaped, for example, to accommodate the inner shaft 590. The knob 584 may be sized and shaped, for example, to be rotatably accommodated within the opening 564 of the knob housing 562. The knob 584 may be, for example, cylindrical in shape and may include a number of grooves or other textures on an outer surface to aid in rotation of the knob 584. The knob 584 may include a through hole 586 extending through the knob 584 from the first end to the second end along the longitudinal axis. The knob 584 may also include a fastening hole 588 extending through the knob 584 perpendicular to the through hole 586. The fixation hole 588 may, for example, extend from the exterior textured surface through a first side of the knob 584 into the through hole 586 and through at least a portion of a second side of the knob 584 opposite the first side hole 588. The fixation hole 588 may be sized and shaped to accommodate, for example, a pin or similar coupling member for securing the inner shaft 590 to the knob 584.
[0069] As best seen in FIG. 59 , the inner shaft 590 can include a first end 592 and a second or engagement end 596. The first end 592 can include a through hole 594 for receiving a pin or similar coupling member to secure the inner shaft 590 to the knob 584. The engagement end 596 can be threaded to engage and couple to the implant 100, 250, 350, 450, for example, for insertion into a patient. The inner shaft 590 can also include a groove 598 disposed adjacent the threads 597 of the engagement end 596. The inner shaft 590 can be inserted into the passage 582 to position the through hole 594 within the knob 584 disposed within the knob housing 562. A pin can be inserted through at least a portion of the first side of the knob 584, the through hole 594 of the inner shaft 590, and the second side of the knob 584 to secure the inner shaft 590 to the knob 584. Once coupled together, rotation of knob 584 also rotates inner shaft 590. Engagement end 596 can extend at least partially from second portion 566 of shaft 558. Specifically, engagement end 596 can be positioned such that threads 597 of inner shaft 590 extend from passageway 582 to engage an implant, such as implants 100, 250, 350, 450.
[0070] 60-63, implants 350, 450 are shown inserted into a patient's ankle. After the bone of the ankle has been prepared for an implant, such as implants 350, 450, the implants 350, 450 may be coupled to an insertion tool 550 and inserted into the patient's ankle. The engagement end 596 of the insertion tool 550 may be inserted, for example, into the through holes 424, 476 of the implants 350, 450, respectively. A guide, such as guide 600, may then be coupled to the mounting portion 570 of the insertion tool 550 for inserting bone screws 640 through the implants 350, 450 and across the joint.
[0071] 60 and 64-69, a guide 600 is shown. The guide 600 may be a precision guide for cross screw placement, such as, for example, an anterior cross screw guide. The guide 600 may be, for example, an anterior cross screw guide. The guide 600 may include an arm 602 and a guide tube 630. The arm 602 may include, for example, a first portion 604 and a second portion 612 connected to the first portion 604 at a connecting portion 610. The connecting portion 610 may be angled, for example, to position the first portion 604 at an angle relative to the second portion 612. The angle between the first portion 604 and the second portion 612 may be, for example, between 75 degrees and 135 degrees, more preferably between 90 degrees and 120 degrees. The arms 602 may each have a polygonal cross section, such as, for example, a generally square or rectangular cross section.
[0072] As best seen in FIGS. 67-69, the first portion 604 can include an alignment portion 606 at a first end of the first portion 604 and a connecting portion 610 at a second end of the first portion 604. The alignment portion 606 can extend from the first portion 604 generally perpendicular to a longitudinal axis of the first portion 604 extending between the connecting portion 610 and the first end. The alignment portion 606 can also include a through hole 608 extending through the alignment portion 606 from the top surface to the bottom surface. The alignment portion 606 can be positioned to align the through hole 608 with the through holes 123, 273, 374 of the implants 100, 250, 350, 450, respectively, for insertion of a bone screw 640, for example.
[0073] 67-69, the second portion 612 may include an attachment portion 614 at a second end of the second portion 612 and a connecting portion 610 at a first end of the second portion 612. The attachment portion 614 may extend from the second portion 612. The attachment portion 614 may include a first leg 616 disposed on an upper side of the attachment portion 614 and a second leg 618 disposed on an underside of the attachment portion 614. The first leg 616 may be spaced apart from the second leg 618 forming a channel 620. The channel 620 may be sized and shaped to accommodate, for example, an engagement surface 572 of the attachment portion 570 of the insertion tool 550. Additionally, at least one of the first leg 616 and the second leg 618 may also include a through hole 622 extending entirely through the first leg 616 and / or the second leg 618. In one embodiment, the through hole 622 may extend, for example, completely through at least one of the first leg 616 and the second leg 618 and then partially through the other of the first leg 616 and the second leg 618. The through hole 622 may be aligned with the hole 578 of the insertion instrument 550, and a fixation pin 624 may be inserted through the hole 622 and the hole 578 to couple the precision guide 600 to the insertion instrument 550. Once the precision guide 600 is coupled to the insertion instrument 550, any rotation and / or translation of the implant 100, 250, 350, 450 is immediately applied to the position of the guide 600 to adjust the cross thread trajectory to match the adjustment of the implant 100, 250, 350, 450.
[0074] 64-69, the guide tube 630 may include a head 632 at a first end of the guide tube 630 and a shaft 634 extending from the head 632 to a second end of the guide tube 630. The guide tube 630 may also include a cannula or throughbore 636 extending through the guide tube 630 from the first end face to the second end face along the longitudinal axis of the guide tube 630. The guide tube 630 may be a tissue protector, k-wire guide, drill guide, etc., as known to those skilled in the art, for example, to aid in the insertion of bone screws 640 using the precision guide 600.
[0075] 70-76, another insertion system 650 is shown. The insertion system 650 includes a precision guide for placing an intramedullary fastener, such as a lateral nail guide. The guide 650 may be, for example, an lateral cross-screw guide. The guide 650 may include a frame 652, a guide tube 630, and at least one angle wing 698. The frame 652 may include a base member 654, a foot 656 at one end of the base member 654, and an arm 682 at another end of the base member 654. The base member 654, the foot 656, and the arm 682 may each have a polygonal cross-section, such as, for example, a generally square or rectangular cross-section.
[0076] As shown in FIGS. 73-76, the foot 656 includes a first foot portion 658 extending in a first direction from the base member 654. The first foot portion 658 extends to a foot connector 660 that couples the first foot portion 658 to a second foot portion 662. The connector 660 is angled, for example, at or about 90 degrees to position the second foot portion 662 extending in the second direction. The second foot portion 662 is coupled to the foot connector 660 at a first end and includes a sleeve 664 at a second end. The sleeve 664 extends from a bottom surface of the second end of the second foot portion 662 past a top surface of the second foot portion 662 and away from the top surface of the second foot portion 662. The sleeve 664 may be, for example, cylindrical in shape. The sleeve 664 may also have a through hole 666 extending from a top surface to a bottom surface of the sleeve 664. The through hole 666 may be sized and shaped to accommodate the guide tube 630, for example, as described in more detail above, but not described again here for brevity. In addition, the sleeve 664 may include a channel 668 extending from an outer surface of the sleeve 664 into the through hole 666. The channel 668 may be spaced apart, for example, from the attachment point of the sleeve 664 to the second foot portion 662. The channel 668 may extend from a top surface to a bottom surface of the sleeve 664. The channel 668 may have a width less than a diameter of the guide tube 630, for example.
[0077] 73-76, the base member 654 may also include an attachment portion 670 for coupling to the attachment portion 570 of the insertion instrument 550. The attachment portion 670 may include a first leg 672 and a second leg 674. The legs 672, 674 each extend away from the base member 654 in a first direction. The first leg 672 may be spaced from the second leg 674 along the length of the base member 654 forming a channel 676 extending between the legs 672, 674 and the base member 654, for example. The channel 676 may be sized and shaped to accommodate the engagement surface 572 of the attachment portion 570, for example. The first leg 672 may include a first through hole 678 extending through a free end of the first leg 672 from the top surface to the bottom surface. The second leg 674 may include a second through hole 680 that extends through a free end of the second leg 674 from the top surface to the bottom surface. The through holes 678, 680 may be aligned with the hole 578 of the insertion instrument 550, and a fixation pin 697 may be inserted through the first hole 678, the hole 578, and the second hole 680 to couple the precision guide 650 to the insertion instrument 550, as shown in FIG. 72. When the precision guide 650 is coupled to the insertion instrument 550, any rotation and / or translation of the implant 100, 250, 350, 450 is immediately applied to the position of the guide 650 to adjust the cross thread trajectory to match the adjustment of the implant 100, 250, 350, 450.
[0078] Additionally, as shown in FIGS. 73-76, an arm 682 may be coupled to the base member 654 at a first end of the base member 654. The arm 682 may include a first arm portion 684 and a second arm portion 692 coupled to the first arm portion 684 by an arm connector 690. The base member 654 may be coupled to the first arm portion 684 between the first and second ends of the first arm portion 684. The first arm portion 684 may extend away from the base member 654 in both a first direction and a third direction opposite the first direction. The first end of the first arm portion 684 may include a first alignment portion 686 extending away from a top surface of the first arm portion 684. The first alignment portion 686 may include a first opening 688 extending into the first alignment portion 686 toward the first arm portion 684. The first opening 688 may be sized and shaped to accommodate, for example, an angle wing 698. The arm connector 690 may be positioned to change the orientation of the second arm portion 692 relative to the first arm portion 684, for example, with the first arm portion 684 extending in a first and third direction and the second arm portion 692 extending in a second direction. The connector 690 may also be angled, for example, to position the first arm portion 684 at an angle relative to the second arm portion 692. The angle between the first arm portion 684 and the second arm portion 692 may be, for example, between 80 degrees and 110 degrees, more preferably about 90 degrees.
[0079] 73-76, a second arm portion 692 is coupled at a first end to the arm connector 690 and at a second end to a second alignment portion 694. The second end of the second arm portion 692 can include a second alignment portion 694 that extends away from a top surface of the second arm portion 692. The second alignment portion 694 can include a second opening 696 that extends into the second alignment portion 694 toward the second arm portion 692. The second opening 696 can be sized and shaped to accommodate, for example, an angle wing 698. The two angle wings 698 can aid in aligning the frame 652 with respect to the patient's bone. The arms 682 can each have a polygonal cross-section, such as, for example, a generally square or rectangular cross-section.
[0080] As shown in FIG. 104, a surgical method for ankle fusion surgery to insert one of the implants 100, 250, 350, 450 includes preparing the joint. In the case of the implants 100, 250, the joint may be prepared by, for example, using a combination of an oscillating, reciprocating saw blade (not shown) and a cutting guide to form a cavity or pocket to accommodate the selected implant 100, 250. The cutting guide may be, for example, a size and shape that allows the joint to be cut to the shape of the implant 100, 250. In the case of the implants 350, 450, the joint may be prepared using a reaming instrument such as a reaming instrument 500 including a hemispherical reaming head 502. The reaming instrument 500 may be used by hand or over a k-wire to shape an existing bone void to form a cavity or pocket sized to accommodate the implant 350, 450. The autograft bone chips formed using the reaming instrument 500 may be collected from the reaming instrument 500 and stored for later use in graft packing. It is also contemplated that the reaming instrument 500 may be used with a parallel reaming guide, for example, to ensure that the reaming passage is formed perpendicular to the long axis of the tibia. The parallel reaming guide may be configured to directly or indirectly engage the reaming instrument 500, for example, and may be used to ensure that the reamer is inserted to form a reaming passage perpendicular to the long axis of the tibia. Ensuring that the reaming passage is perpendicular allows the intramedullary nail to be accurately aligned and placed through the implant 350, 450. The parallel reaming guide may include openings that allow the guide to be secured to the tibia in multiple positions. Optionally, fluoroscopy may be used to help ensure that the parallel reaming guide is placed perpendicular to the tibia while reaching the correct depth of the bone with the reaming instrument 500.
[0081] The method then includes trying out the implant 100, 250, 350, 450 to determine the correct size for the prepared joint. The trial implant 490 may be attached to an insertion instrument 550 and inserted into the reaming channel to determine the size and shape of the implant 100, 250, 350, 450 that will best fit within the cavity or pocket within the joint, as shown in FIG. 77. Once a particular size and shape of implant 100, 250, 350, 450 has been selected, it may be removed from the insertion instrument 550 and the selected implant 100, 250, 350, 450 may be coupled to the inserter 550. The selected implant 100, 250, 350, 450 is coupled to the inserter 550 by inserting and threading the threaded end 596 of the insertion tool 550 into the first through hole 194, 424, 476 of the implant 100, 250, 350, 450 and inserting the recessed area 580 of the shaft 558 of the insertion tool 550 into the recessed area 192, 422, 474 of the selected implant 100, 250, 350, 450, as shown in Figure 77. By inserting the recessed area 580 of the shaft 558 into the recessed area 192, 422, 272 of the selected implant 100, 250, 350, 450, the surgeon may manipulate the implant 100, 250, 350, 450 in rotation and translation in all planes. The threaded end 596 of the inserter 550 is threaded into the through hole 194 , 424 , 476 of the implant 100 , 250 , 350 , 450 by rotating the knob 584 of the inserter 550 until the threads 597 of the inserter 550 engage the threads of the through hole 194 , 424 , 476 .
[0082] The method then includes coupling the precision guide 600, 650 to the inserter 550 for fixation. Fixation may involve, for example, an intramedullary nail or a cross screw and plate. The plate may be, for example, a plate as described in U.S. Provisional Application No. 63 / 227,138, entitled SPAN BONE PLATES, filed July 29, 2021, which is incorporated by reference in its entirety. As described above in more detail, but not described again here for brevity, the mounting portion 614, 670 of the precision guide 600, 650 may be coupled to the precision guide mounting portion 570 of the inserter 550 to insert a cross screw or an intramedullary nail through the implant 100, 250, 350, 450 across the joint. Once the guide 600, 650 is coupled to the inserter 550, any translation or rotation of the inserter 550 and coupled implant 100, 250, 350, 450 is immediately applied to the position of the guide 600, 650 without further manipulation by the surgeon. The implants 100, 250, 350, 450 may all be translated. In addition, the implant 450 may be rotated in all planes and the implant 350 may be rotated in one plane. Thus, the trajectory of the cross thread or intramedullary nail from the guide 600, 650 is maintained as the inserter 550 and coupled implant 100, 250, 350, 450 are moved.
[0083] In one embodiment, once the desired position of the implant 100, 250, 350, 450 is achieved, a k-wire may be inserted through the guide tube 630 of the guide 600 across the joint, as shown in FIG. 78. After the k-wire is placed, the guide 600 may be removed and a drill may be inserted through the joint over the k-wire. After the opening is drilled, a cross screw may be inserted into the opening across the joint. In another embodiment, once the desired position of the implant 100, 250, 350, 450 is achieved, the central nail hole in the implant 100, 250, 350, 450 may be aligned with the long axis of the tibia using the angle wings 698 and fluoroscopy in both the anterior-posterior and medial-lateral views. Once aligned, the guide 650 may be temporarily secured to the bone, as shown in FIG. 79. A k-wire 492 may then be inserted through the guide tube 630 of the guide 650 into the tibial tunnel, as shown in FIG. 80. After placing the k-wire, the guide 650 can be removed and a drill can be inserted over the k-wire and through the joint. After the opening has been drilled, an intramedullary nail can be inserted into the opening across the joint.
[0084] 81-90, another implant 700 is shown. The implant 700 can include a first side or top surface 702, a second side or bottom surface 704, a third side or right surface 706, a fourth side or left surface 708, a fifth side or first end surface 710, and a sixth side or second end surface 712. The first side 702 can extend, for example, generally parallel to the second side 704. The third side 706 can extend, for example, generally parallel to the fourth side 708. The fifth side 710 can extend, for example, generally parallel to the sixth side 712. The implant 700 can also include an internal frame 720 surrounded by an external frame or housing 750. The sides 702, 704, 706, 708, 710, 712 can form the external frame 750. The outer frame 750 may be, for example, prismatic in shape.
[0085] 81-90, the internal frame 720 may include a first intermediate portion 722 disposed on the top of the implant 700 between the first end surface 710 and the midpoint, a second intermediate portion 730 disposed on the bottom of the implant 700 between the midpoint and the second end surface 712, and a third intermediate portion or bottom member 740. The first intermediate portion 722 includes a first segment 724, a second segment 726, and a third segment 728. A first end of the first segment 724 is coupled to the third side 706 of the implant 700. The second segment 726 is coupled to the first segment 724 at a first end. A first end of the third segment 728 is coupled to the second end of the second segment 726, and a second end of the third segment 728 is coupled to the fourth side 708 of the implant 700. Thus, the first intermediate portion 722 extends between the third side 706 and the fourth side 708 of the implant 700. Each of the first, second, and third segments 724, 726, 728 may be curved, for example, between a first end and a second end of each segment 724, 726, 728. The segments 724, 726, 728 may include a concave surface disposed to face the through hole 738, for example. The second intermediate portion 730 includes a fourth segment 732, a fifth segment 734, and a sixth segment 736. A first end of the fourth segment 732 is coupled to the third side 706 of the implant 700. The fifth segment 734 is coupled to the fourth segment 732 at a first end. A first end of the sixth segment 736 is coupled to a second end of the fifth segment 734, and a second end of the sixth segment 736 is coupled to the fourth side 708 of the implant 700. Thus, the second intermediate portion 730 extends between the third side 706 and the fourth side 708 of the implant 700. Each of the fourth, fifth and sixth segments 732, 734, 736 may be curved, for example, between the first and second ends of each segment 732, 734, 736. The segments 732, 734, 736 may include, for example, a concave surface disposed to face the through hole 738. The bottom member 740 is disposed in alignment with, for example, the bottom surface 704 of the implant 700.In addition, the bottom member 740 is disposed, for example, between the third side 706 and the fourth side 708, and between the fifth side 710 and the sixth side 712. The through holes 738 also extend through the bottom member 740. The bottom member 740 may be, for example, circular, oval or round in shape. The bottom member 740 may be sized and shaped to allow, for example, a cross screw or intramedullary nail to be inserted through the bottom surface 704 of the implant 700.
[0086] The external frame or housing 750 may include supports 752, 754, 756, 758, 760, 762, 764 on the third side 706 of the implant 700, as shown in FIG. 86. The first support, first base or first linear member 752 may be disposed, for example, at the lower end of the third side 706, i.e., where the third side 706 engages the second side 704. The first arm, second linear member or second support 754 may extend from a first end of the first support 752, for example, perpendicular to the first support 752. The first arm 754 may be disposed, for example, where the third side 706 engages the fifth side 710. The second arm, third linear member or third support 756 may extend from the second end of the first support 752, for example, perpendicular to the first support 752. The fourth linear member or fourth support 758 may extend from the first end of the first arm 754 toward the through hole 738 of the internal frame 720. The fifth linear member or fifth support 760 may extend from the first end of the second arm 756 toward the through hole 738 of the internal frame 720. The first guide hole member or sixth support 762 may extend, for example, between the fourth linear member 758 and the fifth linear member 760. The first guide hole member 762 may be curved, for example. The curved portion of the first guide hole member 762 may be a concave curved portion, for example. The first guide hole member 762 may be sized and shaped to allow, for example, a cross thread to be inserted through the implant 700 at an angle that extends beyond the first guide hole member 762 during insertion from the third side 706. The third arm, sixth linear member or seventh support 764 may be coupled at a first end to an intermediate portion of the first guide hole member 762 and at a second end to the first base 752. The third arm 764 may be coupled, for example, to a distal-most portion of the first guide hole member 762. The first arm 754, second arm 756 and third arm 764 may each extend parallel to one another, for example, as the arms 754, 756, 764 extend from the bottom surface 704 toward the top surface 702. The third side 706 may also include at least one first window 766 and at least one second window 768, as shown in FIGS.At least one first window 766 may be disposed, for example, between a portion of the first base 752, the first arm 754, the fourth linear member 758, the first portion of the first guide hole member 762, and the third arm 764. Thus, the first base 752, the first arm 754, the fourth linear member 758, the first portion of the first guide hole member 762, and the third arm 764 provide an enclosure structure for forming at least one first window 766 extending through the third side surface 706. At least one second window 768 may be disposed, for example, between a portion of the first base 752, the second arm 756, the fifth linear member 760, the second portion of the first guide hole member 762, and the third arm 764. Thus, the first base 752, the second arm 756, the fifth linear member 760, the second portion of the first guide hole member 762, and the third arm 764 provide an enclosure structure for forming at least one second window 768 extending through the third side 706.
[0087] 85, the internal frame 720 may also include supports 770, 772, 774, 776, 778, 780, 782 on the fourth side 708 of the implant 700. The eighth support, second base or seventh linear member 770 may be located, for example, at the bottom end of the fourth side 708, i.e., where the fourth side 708 engages the second side 704. The fourth arm, eighth linear member or ninth support 772 may extend from a first end of the eighth support 770, for example, perpendicular to the eighth support 770. The fourth arm 772 may be located, for example, where the fourth side 708 engages the fifth side 710. A fifth arm, ninth linear member or tenth support 774 may extend from a first end of the second base 770, for example, perpendicular to the second base 770. A tenth linear member or eleventh support 776 may extend from a first end of the fourth arm 772 toward the through hole 738 of the internal frame 720. The eleventh support 776 may extend between the fourth arm 772 and the third segment 728 of the first intermediate portion 722. An eleventh linear member or twelfth support 778 may extend from a first end of the fifth arm 774 toward the through hole 738 of the internal frame 720. The twelfth support 778 may extend between the fifth arm 774 and the sixth segment 736 of the second intermediate portion 730. The second guide hole member or thirteenth support 780 can extend between the tenth linear member 776 and the eleventh linear member 778, for example. The second guide hole member 780 can be curved, for example. The curve of the second guide hole member 780 can be a concave curve, for example. The second guide hole member 780 can be sized and shaped to allow, for example, cross threads to be inserted through the implant 700 at an angle that extends beyond the second guide hole member 780 during insertion from the fourth side 708. The sixth arm, twelfth linear member or fourteenth support 782 can be coupled at a first end to a middle portion of the second guide hole member 780 and at a second end to the second base 770. The sixth arm 782 can be coupled, for example, to a distal-most portion of the second guide hole member 780.The fourth arm 772, the fifth arm 774, and the sixth arm 782 may each extend parallel to one another, for example, as the arms 772, 774, 782 extend from the bottom surface 704 toward the top surface 702. The fourth side 708 may also include at least one third window 784 and at least one fourth window 786, as shown in FIGS. 81 and 85. The at least one third window 784 may be disposed intermediate the second base 770, the fourth arm 772, the tenth linear member 776, the first portion of the second guide hole member 780, and the sixth arm 782, for example. Thus, the second base 770, the fourth arm 772, the tenth linear member 776, the first portion of the second guide hole member 780, and the sixth arm 782 provide an enclosure structure for forming at least one third window 784 extending through the fourth side surface 708. The at least one fourth window 786 may be disposed, for example, intermediate between a portion of the second base 770, the fifth arm 774, the eleventh linear member 778, the second portion of the second guide hole member 780, and the sixth arm 782. Thus, the second base 770, the fifth arm 774, the eleventh linear member 778, the second portion of the second guide hole member 780, and the sixth arm 782 provide an enclosure structure for forming at least one fourth window 786 extending through the fourth side surface 708.
[0088] 83, the external frame 750 may also include a first support member 790 on the fifth side 710 of the implant 700. The first support member 790 may include a first recessed region 792 extending from the fifth side 710 into a middle portion. The first recessed region 792 may have, for example, a length, a width, and a height, where the length may be greater than the height. For the first recessed region 792, the height may extend in a direction between the top surface 702 and the bottom surface 704, the length may extend in a direction between the third side 706 and the fourth side 708, and the width may extend in a direction between the first end surface 710 and the second end surface 712. The first recessed region 792 may have, for example, a flat bottom surface and be rounded or curved between a first end and a second end of the flat bottom surface. The first recessed area 792 may be, for example, oval, elliptical, or sideways D-shaped. The first recessed area 792 may be, for example, a non-circular shape. The first support member 790 may also include a first through hole 794 extending through the first support member 790. The first through hole 794 may, for example, extend completely through the fifth side 710 of the implant 700. The first through hole 794 may include threads 796 on an inner surface, for example.
[0089] The first support member 790 may also include at least one fifth window, top window, or opening 798 extending through the first support member 790. The at least one fifth window 798 may include, for example, two parallel sides, a top portion connecting the two parallel sides at a first end, and a base portion connecting the two parallel sides at a second end. The top and bottom portions may be parallel to each other, for example, as they extend between the two sides. The at least one fifth window 798 may be, for example, at least two windows 798 disposed on the inside and outside of the fifth side 710. As shown in the illustrated embodiment, the two fifth windows 798 may be disposed near the top end of the implant 700 such that they are mirror images of each other.
[0090] The first support member 790 may also include at least one sixth window, lower window, or opening 800 extending through the first support member 790, as shown in FIG. 83. The at least one sixth window 800 may include, for example, two parallel sides, a top portion connecting the two parallel sides at a first end, and a base portion connecting the two parallel sides at a base end. The top and bottom portions may be parallel to each other, for example, as they extend between the two sides. The at least one sixth window 800 may be, for example, at least two windows 800 disposed on the inner and outer sides of the fifth side 710. As shown in the illustrated embodiment, the two sixth windows 800 may be disposed near the lower end of the fifth side 710 of the implant 700 such that they are mirror images of each other. The first support member 790 may also include at least one seventh window, middle window, or opening 802. The at least one seventh window 802 can be located, for example, adjacent to the first recessed region 792. In the illustrated embodiment, the at least one seventh window 802 is one seventh window 802 located below the recessed region 792, between the recessed region 792 and the bottom surface 704 of the implant 700.
[0091] 84, the frame 750 may include a second support member 804 on a sixth side 712 of the implant 700. The second support member 804 may include a second recessed region 806 extending from the sixth side 712 into a middle portion. The second recessed region 806 may have, for example, a length, a width, and a height, where the length may be greater than the height. The height may extend in a direction between the top surface 702 and the bottom surface 704, the length may extend in a direction between the third side 706 and the fourth side 708, and the width may extend in a direction between the first end surface 710 and the second end surface 712. The second recessed region 806 may have, for example, a flat bottom surface and be rounded or curved between a first end and a second end of the flat bottom surface. The second recessed region 806 may be, for example, oval, elliptical, or sideways D-shaped. The second recessed area 806 may, for example, be a non-circular shape. The second support member 804 may also include a second through hole 808 extending therethrough. The second through hole 808 may, for example, extend completely through the sixth side 712 of the implant 700. The second through hole 808 may, for example, include threads 810 disposed on an inner surface of the second through hole 808.
[0092] The second support member 804 may also include at least one eighth window, top window, or opening 812 extending through the second support member 804. The at least one eighth window 812 may include, for example, two parallel sides, a top portion connecting the two parallel sides at a first end, and a base portion connecting the two parallel sides at a second end. The top portion and base portion may be disposed parallel to each other, for example, as they extend between the two sides. The at least one eighth window 812 may be, for example, at least two windows 812 disposed on the inside and outside of the sixth side 712. As shown in the illustrated embodiment, the two eighth windows 812 may be disposed near the top end of the implant 700 such that they are mirror images of each other.
[0093] The second support member 804 may also include at least one ninth window, lower window, or opening 814 extending through the second support member 804. The at least one ninth window 814 may include, for example, two parallel sides, a top portion connecting the two parallel sides at a first end, and a base portion connecting the two parallel sides at a second end. The top portion and the base portion may be parallel to each other, for example, as they extend between the two sides. The at least one ninth window 814 may be, for example, at least two windows 814 disposed on the inner and outer sides of the sixth side 712. As shown in the illustrated embodiment, the two ninth windows 814 may be disposed near the lower end of the sixth side 712 of the implant 700 such that they are mirror images of each other. The second support member 804 may also include at least one tenth window, middle window, or opening 816. The at least one tenth window 816 can be disposed adjacent to the second recessed region 806, for example. In the illustrated embodiment, the at least one tenth window 816 is, for example, one tenth window 816 disposed below the second recessed region 806, between the second recessed region 806 and the bottom surface 704. In the illustrated embodiment, the windows 798, 800, 802, 812, 814, 816 can be, for example, square or rectangular in shape, although alternative shapes are contemplated as disclosed above with respect to the implant 100 and will not be described again here for the sake of brevity.
[0094] 81 and 85-90, the frame 750 may also include a first protrusion, internal protrusion, or first screw housing 818 extending away from the inner surface of the fifth side 710. The first protrusion 818 may be located, for example, intermediate the first and second sides 702 and 704 and the third and fourth sides 706 and 708. The first protrusion 818 may have a cylindrical or elliptical cylindrical shape as the first protrusion 818 extends from the fifth side 710 toward the sixth side 712, as shown in FIGS. 81, 89, and 90. A first through hole 794 may extend through the first protrusion 818.
[0095] 82 and 87-90, the frame 750 may include a second protrusion, internal protrusion, or second screw housing 820 extending away from the inner surface of the sixth side 712. The second protrusion 820 may be located, for example, intermediate the first and second sides 702 and 704 and the third and fourth sides 706 and 708. The second protrusion 820 may have a cylindrical or elliptical cylindrical shape as the second protrusion 820 extends from the sixth side 712 toward the fifth side 710, as shown in FIG. 82 and 90. The second through hole 808 may extend through the second protrusion 820.
[0096] 81 and 87-90, the implant 700 may also include a first passageway 822 extending between the outer frame 750 and the inner frame 720 near the first end surface 710. The first passageway 822 opens from the first side surface 702 to the second side surface 704. The first through hole 794 and openings 798, 800, 802 extend from the outer surface of the frame 750 to the passageway 822. The implant 700 may further include a second passageway 824 extending between the outer frame 750 and the inner frame 720 near the second end surface 712. The second passageway 824 opens from the first side surface 702 to the second side surface 704. The second through hole 808 and openings 812, 814, 816 extend from the outer surface of the frame 750 to the passageway 824.
[0097] Although not shown, the implant 700 may also include a lattice structure disposed within the openings 766, 768, 784, 786, 798, 800, 802, 812, 814, 816, 822, 824 of the implant 700. The lattice structure may be disposed within the first and second passageways 822, 824, for example, to aid in bone fusion. The lattice structure may be in a plane with the sides 702, 704, 703, 708, 710, 712 of the implant 700, for example, or may be recessed into the implant 700 from the exterior surface of the sides 702, 704, 703, 708, 710, 712. The lattice structure may be printed within the first and second passageways 822, 824, for example. The lattice structure may be a non-nodal randomized web-based matrix, for example. The lattice structure matrix may have a pore size of, for example, about 4 mm to about 5 mm. The lattice structure may include, for example, coarse elements spanning between structures forming the passages 822, 824. The lattice structure may be offset from the outer frame of the implant 700, for example. The lattice structure may be offset by about 0.5 mm to the inside of the frame of the implant 700. Thus, the frame of the implant 700 is the only bone contacting element after implantation, and the lattice structure does not directly contact the bone.
[0098] The implant 700 may be inserted into the patient's ankle as described in more detail above with respect to the surgical method for the implant 100, which will not be described again here for brevity. Specifically, the implant 700 may be inserted into the patient using an anterior approach. In addition, the implant 700 may use cross screws, cross screws and a plate, or an intramedullary nail to secure the implant 700 in the patient's ankle.
[0099] 91-102, another implant 850 is shown. The implant 850 may include a first side or top surface 852, a second side or bottom surface 854, a third side or right surface 856, a fourth side or left surface 858, a fifth side or first end surface 860, and a sixth side or second end surface 862. The first side 852 and the second side 854 may each be curved in opposite directions, for example, to give the implant 850 a generally circular or ball shape. The third side 856 and the fourth side 858 may also each be curved in opposite directions, for example. Additionally, the fifth side 860 and the sixth side 862 may also each be curved in opposite directions, for example. The implant 850 may also include an internal frame 870 surrounded by or disposed within an external frame or housing 900. The outer frame 900 may be, for example, spherical in shape.
[0100] The internal frame 870 may include a first intermediate portion 872 and a second intermediate portion 884, as shown in Figs. 91-102. The first intermediate portion 872 may be disposed, for example, on the top surface 852 of the implant 850, and the second intermediate portion 884 may be disposed, for example, on the bottom surface 854 of the implant 850. The first intermediate portion 872 may include a first ring segment or first lobe 874, a second ring segment or second lobe 876, and two connecting segments 878, 880 extending between the first lobe 874 and the second lobe 876. The first intermediate portion 872 may be curved, for example, as it extends between the third side 856 and the fourth side 858. The first lobe 874 is disposed on the third side 856 of the implant 850, and the second lobe 876 is disposed on the fourth side 858. The lobes 874, 876 may, for example, be curved from their connection points with the connecting segments 878, 880 as they extend to the third and fourth sides 856, 858, respectively. The lobes 874, 876 may, for example, be horseshoe-shaped, open-ring-shaped, or U-shaped segments connected to one another by the connecting segments 878, 880 to form a through hole 882. The through hole 882 may, for example, have three overlapping circles: a first circle formed by the first lobe 874, a second circle formed by the first and second connecting segments 878, 880, and a third circle formed by the second lobe 876. A first end of the first connecting segment 878 is connected to a first end of the first lobe 874, and a second end of the first connecting segment 878 is connected to a first end of the second lobe 876. A first end of the second connecting segment 880 is connected to a second end of the first lobe 874, and a second end of the second connecting segment 880 is connected to a second end of the second lobe 876.
[0101] 91-102, the second intermediate portion 884 can include a body 886 having a first lobe 888 and a second lobe 890. The body 886 can be disposed on the second side 854 of the implant 850, for example. The first lobe 888 can extend away from a portion of the body 886 intermediate the third side 856 and the sixth side 862 of the implant 850. The second lobe 890 can extend away from a portion of the body 886 intermediate the fourth side 858 and the sixth side 862. The first lobe 888 can be spaced from the second lobe 890 between the third side 856 and the fourth side 858 on the sixth side 862. The body 886, the first lobe 888, and the second lobe 890 may form an exterior structure surrounding a through hole 882 extending from the first intermediate portion 872. The through hole 882 extends through the implant 850 to accommodate a cross screw or an intramedullary nail. The first lobe 874 of the first intermediate portion 872 may be angled to align with the second lobe 890 of the second intermediate portion 884 in a first direction. The second lobe 876 of the first intermediate portion 872 may be angled to align with the first lobe 888 of the second intermediate portion 884 in a second direction. The first direction and the second direction may include tracks extending in opposite directions. A first trajectory extending between the first lobe 874 and the second lobe 890 may overlap with a second trajectory extending between the second lobe 876 and the first lobe 888 as the trajectories extend through the implant 850 from the first side 852 to the second side 854. The positioning of the lobes 874, 876, 888, 890 may allow, for example, cross screws to be inserted at an angle as they pass through the joint.
[0102] As shown in FIGS. 91 to 102, the external frame 900 may include a plurality of connecting portions 902 and a plurality of support arms 912, 914, 916, 918 that are connected to the connecting portions 902 and connect the connecting portions 902. The connecting portions 902 may be disposed, for example, on the third side 856, the fourth side 858, the fifth side 860, and the sixth side 862. The connecting portion 902 disposed on the third side 856 faces the connecting portion 902 disposed on the fourth side 858. The connecting portion 902 disposed on the fifth side 860 faces the connecting portion 902 disposed on the sixth side 862. The first support arm 912 may extend between the connecting portion 902 on the fifth side 860 and the connecting portion 902 on the third side 856 and connect them. The second support arm 914 may extend between and connect the connecting portion 902 of the third side 856 and the connecting portion 902 of the sixth side 862. The third support arm 916 may extend between and connect the connecting portion 902 of the sixth side 862 and the connecting portion 902 of the fourth side 858. Finally, the fourth support arm 918 may extend between and connect the connecting portion 902 of the fourth side 858 and the connecting portion 902 of the fifth side 860. The connecting portion 902 and the arms 912, 914, 916, 918 of the outer frame 900 together form a ring around the inner frame 870.
[0103] The outer frame 900 may also include cross members 920, 924, 928 connecting the first intermediate portion 872, the second intermediate portion 884, and at least one of the connecting portion 902 and / or the arms 912, 914, 916, 918. For example, as shown in FIGS. 92-95, 97-99, and 101-102, the first cross member 920 may connect at a first end to the first intermediate portion 872, extend through the second arm 914, and connect at a second end to the second intermediate portion 884. The first cross member 920 extends beyond the second arm 914 to form a first node 922. The first node 922 forms an enlarged portion near the midpoint of the second arm 914. The second cross member 924 may be connected to the first intermediate portion 872 at a first end, extend through the third arm 916, and connect to the second intermediate portion 884 at a second end. The second cross member 924 extends beyond the third arm 916 to form a second node 926. The second node 926 forms an enlarged portion near the midpoint of the third arm 916. The third cross member 928 may be connected to the first intermediate portion 872 at a first end, engage both sides of the connecting portion 902 near the midpoint, and connect to the second intermediate portion 884 at a second end. As shown in FIGS. 91-96 and 100, the third cross member 928 engages the connecting portion 902 at a fifth side 860 of the implant 850. The third cross member 928 may include two supports 830, 832. The two supports may be a seventh support 830 and an eighth support 832. The seventh support 830 may be connected at a first end to the first intermediate portion 872 and at a second end to the connecting portion 902, while the eighth support 832 may be connected at a first end to the connecting portion 902 and at a second end to the second intermediate portion 884, as shown in FIGS. 91, 93, 95, 96, and 100. The cross members 920, 924, 928 connect the inner frame 870 to the outer frame 900. In addition, the cross members 920, 924, 928 may be spaced apart around the implant 850. The spacing of the cross members 920, 924, 928 may be, for example, evenly spaced around the outer surface of the implant 850 or unequally spaced around the outer surface of the implant 850.
[0104] The connecting portion 902 can have a first height extending in a direction between the first side 852 and the second side 854 and a first width extending from an outer surface to an inner surface of the implant 850. The arms 912, 914, 916, 918 can have a second height extending in a direction between the first side 852 and the second side 854 and a second width extending from an outer surface to an inner surface of the implant 850. The first height of the connecting portion 902 can be greater than the second heights of the arms 912, 914, 916, 918, for example. The first width of the connecting portion 902 can be the same as or greater than the second widths of the arms 912, 914, 916, 918, for example.
[0105] Each of the connecting portions 902 may also include a recessed area 904 recessed into the connecting portion 902 from the outer surface to the inner surface of the external frame 900. The recessed area 904 may extend from the outer surface of the implant 850 into the connecting portion 902 to the inner surface 906 of the recessed area 904. The recessed area 904 may have, for example, a flat bottom surface and be rounded or curved between a first end and a second end of the flat bottom surface. The recessed area 904 may have, for example, an oval, elliptical, or sideways D-shape. Additionally, the connecting portions 902 may include a through hole 908 extending through each connecting portion 902 from the inner surface 906 of the recessed area 904 to the inner surface of the external frame 900. The through hole 908 may be centered about the recessed area 904. Thus, the through hole 908 may overlap the recessed area 904 in the connecting portion 902. The through hole 908 may be threaded to engage, for example, an inserter, such as inserter 550, which will not be described again here for the sake of brevity, or a similar inserter having a threaded portion for engaging the threads of the through hole 908.
[0106] The implant 850 may also include openings 934, 936, 938, 940, 942, 944 that extend through the implant between the inner frame 870 and the outer frame 900. A first opening 934 may extend between the first intermediate portion 872 and the connecting portion 902, the arms 912, 914 and the cross members 920, 928 of the outer frame 900, as shown in FIG. More specifically, the first opening 934 extends between the first arm 912, a portion of the second arm 914 extending between the connecting portion 902 of the third side 856 and the first node 922, a portion of the first cross member 920 extending between the first node 922 and the second connecting segment 880, a portion of the second connecting segment 880 extending between the first cross member 920 and the first lobe 876, a portion of the first connecting segment 878 extending between the first lobe 876 and the seventh support 930, and the seventh support 930. The second opening 936 may extend between the connecting portion 902, the arms 912, 914, and the cross members 920, 928 of the outer frame 900 and the second intermediate portion 884, as shown in FIG. Specifically, the second opening 936 extends through a portion of the body 886 extending between the eighth support 932 of the third cross-member 928 and the first cross-member 920, a portion of the first cross-member 920 extending between the first lobe 888 of the second intermediate portion 884 and the connecting portion 902 of the sixth side 862, the second arm 914 between the first node 922 and the connecting portion 902 of the third side 856, the first arm 912, and the eighth support 932 of the third cross-member 928. The third opening 938 can extend between the connecting portion 902, the arms 916, 918, and the cross-members 924, 928 of the outer frame 900 and the first intermediate portion 872, as shown in FIG.Specifically, the third opening 938 extends between a portion of the third arm 916 extending between the second node 926 and the connecting portion 902 of the fourth side 858, the fourth arm 918, the seventh support 930 of the third cross member 928, a portion of the first connection segment 878 extending between the seventh support 930 and the second lobe 876, the second lobe 876, a portion of the second connection segment 880 extending between the second lobe 876 and the first end of the second cross member 924, and a portion of the second cross member 924 extending from the second connection segment 880 to the second node 926. 96 , the fourth opening 940 can extend between the connecting portion 902, the arms 916, 918, and the cross members 924, 926 of the outer frame 900 and the second intermediate portion 884. Specifically, the fourth opening 940 extends between a portion of the body 886 extending between the second cross member 924 and the eighth support 932 of the third cross member 928, the fourth arm 918, the connecting portion 902 of the fourth side 858 of the implant 850, a portion of the third arm 916 extending between the connecting portion 902 and the second node 926, and a portion of the second cross member 924 extending between the second node 926 and the second intermediate portion 884. The fifth opening 942 may extend between the fourth connecting portion 902 of the sixth side 862, portions of the arms 914, 916, portions of the cross members 920, 924, and the second connecting segment 880, as shown in FIG. Specifically, the fifth opening 942 extends between a portion of the second connection segment 880 between the first cross member 920 and the second cross member 924, a portion of the first cross member 920 extending between the second connection segment 880 and the first node 922, a portion of the second arm 914 extending between the first node 922 and the fourth linking portion 902, the fourth linking portion 902, a portion of the third arm 916 extending between the fourth linking portion 902 and the second node 926, and a portion of the second cross member 924 extending between the second node 926 and the second connection segment 880. The sixth opening 944 may extend between the fourth linking portion 902, portions of the arms 914, 916, portions of the cross members 920, 924, and the second intermediate portion 884, as shown in FIG.Specifically, the sixth opening 944 extends between a portion of the second arm 914 extending between the first node 922 and the fourth connecting portion 902, the fourth connecting portion 902, a portion of the third arm 916 extending between the fourth connecting portion 902 and the second node 926, a portion of the second cross member 924 extending between the second node 926 and the second lobe 890 of the second intermediate portion 884, the body 886 between the second cross member 924 and the first cross member 902, and a portion of the first cross member 902 extending between the first lobe 888 of the second intermediate portion 884 and the first lobe 922.
[0107] As shown in FIG. 103, the implant 850 may also include a lattice structure 950 disposed within the openings 934, 936, 938, 940, 942, 944 of the implant 850. The lattice structure 950 may be the same as or similar to any other lattice structure shown and described in this application, for example. In addition, the lattice structure 950 may be composed of randomly organized elements, for example. The lattice structure 950 may also have a surface roughness that varies across the elements that make up the lattice structure 950, for example. Furthermore, the lattice structure 950 may not include defined nodes and / or linear struts, for example. The lattice structure 950 may be offset from the outer frame of the implant 850, for example. The lattice structure 950 may be offset about 0.5 mm to the inside of the frame of the implant 850. Thus, the frame of the implant 850 is the only bone-contacting element after implantation, and the lattice structure 950 does not directly contact the bone.
[0108] 103, the lattice structure 950 may be positioned within the openings 934, 936, 938, 940, 942, 944, for example, to aid in bone fusion. The lattice structure 950 may be aligned with a spherical outer surface, for example, on the sides 852, 854, 856, 858, 860, 862 of the implant 850, or may be recessed below the spherical outer surface of the implant 850. The lattice structure 950 may have an outer boundary that is recessed from the spherical outer surface by, for example, about 0.5 mm to 3 mm (e.g., recessed such that one or more outer boundaries of the lattice structure 950 are disposed radially inward from the spherical outer surface of the implant). Additionally, the lattice structure may be recessed from the spherical outer surface of the implant by about 1 mm. In some aspects, the lattice structure 950 may be consistently recessed from the spherical outer surface as shown and described with reference to FIGS. 91-102, or may be variably recessed (e.g., different portions of the lattice structure 950 may be recessed varying distances from the spherical outer surface of the implant 850, with the radially outermost point of the lattice structure 950 being recessed at least 0.5 mm from the spherical outer surface). The implant 850 may also be fabricated such that the external frame 900 protrudes relative to the lattice structure 950. In certain embodiments, this may be accomplished by creating the lattice structure 950 within the external frame 900.
[0109] The lattice structure 950 may be printed, for example, within the openings 934, 936, 938, 940, 942, 944. The lattice structure 950 may be, for example, a non-nodal randomized web-based matrix. The lattice structure matrix 950 may have a pore size, for example, of about 4 mm to about 5 mm. The lattice structure 950 may also include coarse elements that span between the structures that form the openings 934, 936, 938, 940, 942, 944, for example.
[0110] The implant 850 may be inserted into the patient's ankle as described in more detail above with respect to the surgical method for the implant 100, which will not be described again here for brevity. Specifically, the implant 850 may be inserted into the patient using either an anterior, lateral, or posterior approach. In addition, the implant 850 may be secured in the patient's ankle using cross screws, cross screws and a plate, or an intramedullary nail.
[0111] Each lattice structure 230, 950 is an acyclic, organically generated geometry. The ends of the lattice structures 230, 950 are mixed and randomized throughout the interior of the implant. The lattice structures 230, 950 can be formed to accept, for example, demineralized bone matrix, bone cement, or other biologics. In addition to the lattice structures, the implants disclosed herein can also include one or more openings extending through the implant to allow for the passage of various fixation elements, for example, intramedullary nails, cross screws, and the like. The one or more openings for accepting fixation elements can be positioned, for example, at an oblique angle to the vertical. Each of the implants disclosed herein can also be customizable to a particular patient's anatomy. In the case of patient-specific implants, the implant geometry can be designed to be complementary to the patient's anatomy, for example, to address voids, cysts, or other abnormalities in bone, including the distal tibia.
[0112] 105-110, a trial implant 1000 is shown. The trial implant 1000 includes an outer surface 1002 having a spherical shape, an upper surface 1004, and a bottom surface 1006. The upper surface 1004 and the bottom surface 1006 are, for example, flat surfaces disposed on opposite sides of the outer surface 1002. The trial implant 1000 includes an inserter opening 1008 recessed into the outer surface 1002 of the trial 1000. The inserter opening 1008 includes a recessed area 1010 extending from the outer surface 1002 into the trial 1000, and a through hole 1012 extending from an inner surface of the recessed area 1010 into the trial 1000. The through hole 1012 may be threaded to engage and couple with a threaded portion of the inserter 1030, for example. The recessed area 1010 may have a size larger than the size of the through hole 1012, for example, to receive the end of the inserter 1030. The trial product 1000 may also include a plurality of holes 1014 for receiving radiopaque markers 1016. The opening for receiving the insertion tool 550 in the implant 100, 450, 700, 850 may include an inserter opening 1008 in place of the inserter opening described in more detail above.
[0113] 111-114, another embodiment of an insertion tool 1030 is shown. The insertion tool 1030 is similar to the insertion tool 550, as described in more detail above. The tool 1030 includes a first end 1032 and a second end 1034. The tool 1030 also includes a handle 1036, a shaft 1040 coupled to the handle 1036, and an inner shaft 590 rotatably received within the shaft 1040. The inner shaft 590 is as described above with reference to the tool 550, and will not be described again here for the sake of brevity. The handle 1036 is disposed at the first end 1032 of the insertion tool 1030. The handle 1036 includes a plurality of openings 1038 extending therethrough from the tool's first end 1032 to a second end 1034 disposed on either side of the shaft 1040. The handle 1036 may include an opening for receiving the shaft 1040, or alternatively, the shaft 1040 may be integrally coupled to the handle 1036, for example. The shaft 1040 may include a first portion 560, a knob housing 562, and a second portion 1042. The first portion 560 is disposed at a first end of the shaft 1040 and is coupled to the handle 1036, extending from the handle 1036 to the second end 1034 of the insertion instrument 1030. The knob housing 562 is coupled to the first portion 560 at a first end of the knob housing 562 and to the second portion 1042 at a second end of the knob housing 562. The first portion 560 and the knob housing 562 are as described above with reference to the instrument 550 and will not be described again here for brevity. The second portion 1042
[0114] The second portion 1042 extends from the second end of the knob housing 562 toward the second end 1034 of the insertion instrument 1030. The second portion 1042 can include at least one through hole 568 extending through the second portion 1042 in a direction perpendicular to a longitudinal axis of the shaft 1040 extending between the first end 1032 and the second end 1034 of the insertion instrument 1030. The at least one through hole 568 can be aligned with the longest portion of the handle 1036, for example. The at least one through hole 568 can be, for example, three through holes 568, although alternative numbers of through holes 568 are also contemplated. It is also contemplated that the through holes 568 can be positioned to extend through the second portion 1042 in any orientation, for example.
[0115] 111-114, the second portion 1042 also includes a precision guide mounting portion 570. The mounting portion 570 may be as described above with reference to the instrument 550 and will not be described again here for brevity. The first and second protrusions 574, 576 aid in holding a guide, such as guides 1050, 1120, 1140, 1180, in a desired position along the shaft 1040 of the insertion instrument 1030. The mounting portion 570 also includes a bore 578 extending into the engagement surface 572. The bore 578 may extend through at least a portion of the second portion 1042 to one side of the engagement surface 572. The second portion 1042 may also include a recessed region 1044 at the second end of the shaft 1040. The recessed region 1044 may be located on a side of the second portion 1042 perpendicular to the opening 564, for example. The recessed area 1044 may be, for example, tapered, curved, or arcuate extending from a location offset from the second end 1034 of the insertion instrument 1030 to the second end of the second portion 1042. In addition, the shaft 1040 may include a passageway 582 that extends from the second end of the second portion 1042 of the shaft 1040 to the opening 564 in the knob housing 562. The passageway 582 may be sized and shaped to accommodate, for example, an inner shaft 590.
[0116] 115-125, a precision guide 1050 is shown. The guide 1050 includes a body 1052 having a first end 1054 and a second end 1056. The body 1052 may be shaped, for example, to have a main member with two extensions extending in the same direction from the first end 1054 and the second end 1056. The first end 1054 of the body 1052 includes a first alignment arm 1058 that extends away from the body 1052 in a first direction. The alignment arm 1058 includes a free or alignment end 1060 for receiving at least one k-wire 1048. The k-wire 1048 may be received, for example, through at least one of a plurality of through holes 1062 extending through the alignment end 1060. The through hole 1062 may be sized and shaped to receive, for example, the guide tube 630 for inserting the k-wire 1048 into the patient. The alignment end 1060 also includes a protrusion 1064 extending away from a top surface of the alignment end 1060. The protrusion 1064 may extend away from the arm 1058, for example, perpendicular to the through hole 1062. The protrusion 1064 may include an opening 1066 extending from the first end toward the arm 1058. The opening 1066 may be threaded to receive an alignment member 1068, for example, to aid in aligning the guide and implant during surgery.
[0117] The first end 1054 of the body 1052 may also include a connecting member 1070 having a body 1072, a mounting portion 614, and a second alignment end 1086, as shown in FIGS. 115-125. The body 1072 may have, for example, a rectangular shape with four members extending away from the body 1052. The mounting portion 614 may be coupled to and extend from the body 1072. The mounting portion 614 is as described in more detail above and will not be described again here for brevity. The mounting portion 614 may include a through hole 622 extending through the legs 616, 618 and sized and shaped or configured to receive the connecting member 1078. The connecting member 1078 may include a head 1080 and a shaft 1082 extending from the head 1080. The shaft 1082 may be received within the through hole 622 and may include a threaded portion 1084 for coupling to the inserter 1030. The alignment end 1086 may include a number of through holes 1088 extending therethrough. The through holes 1088 may be sized and shaped to receive, for example, the guide tube 630 for inserting the k-wire 1048 into the patient. The alignment end 1086 also includes a protrusion 1090 extending away from a top surface of the alignment end 1086. The protrusion 1090 may extend in a direction away from the top surface of the coupling member 1078, for example perpendicular to the through hole 1088. The protrusion 1090 may include an opening 1092 extending from the first end toward the number of through holes 1088. The opening 1092 may be threaded to receive, for example, the alignment member 1068 to aid in aligning the guide and implant during surgery.
[0118] 115-125, the body 1052 may also include an alignment portion 1094 extending from a second end 1056 of the body 1052. The alignment portion 1094 may have a frame 1096 coupled to and extending from the body 1052. The frame 1096 may be coupled to the body 1052 with at least one fastener 1104. The frame 1096 may have an alignment hub 1098 coupled to the second end of the frame 1096. The alignment hub 1098 may have a round or circular shape, for example. The alignment hub 1098 may include a plurality of through holes 1100 extending through the alignment hub 1098 from a top surface to a bottom surface. The through holes 1100 may be circumferentially spaced about the alignment hub 1098. The through hole 1100 may be sized and shaped to receive, for example, a guide tube 630 for inserting a k-wire 1048 into a patient. The alignment hub 1098 may also include a protrusion 1102 extending away from a bottom surface of the alignment hub 1098. The protrusion 1102 may be disposed, for example, in the center of the alignment hub 1098 and may include a through hole 1106 extending through the alignment hub 1098 and the protrusion 1102. The through hole 1106 may be sized and shaped or configured to receive, for example, a drill guide 1108 for drilling an opening to receive an intramedullary nail.
[0119] After the patient's bone has been prepared, a trial implant, such as trial implant 1000, may be coupled to the inserter 1030 and inserted into the prepared bone to determine the appropriate size implant 100, 450, 700, 850 to be used, as shown in FIG. 105. Imaging may be used to determine the location of the radiopaque marker 1020 on the trial implant 1000 while evaluating the fit of the implant 100, 450, 700, 850. Once selected, the implant 100, 450, 700, 850 may be, for example, implant 100, 450, 700, 850. Then, as shown in FIGS. 115-117, a precision guide 1050 may be coupled and used to insert the nail after the implant 100, 450, 700, 850 has been inserted using an anterior approach.
[0120] 126-136, another precision guide 1120 is shown. The guide 1120 includes a body 1122, an arm 1124 extending away from a first end of the body 1122 in a first direction, and a base 1132 disposed at a second end of the body 1122. The arm 1124 includes an alignment end 1126 extending from the arm 1124 at an opposite end of the body 1122. The alignment end 1126 may extend perpendicularly away from the arm 1124, for example. The arm 1126 may include a protrusion 1128 extending away from a bottom surface of the alignment end 1126. The protrusion 1128 may include an opening 1130 extending through the protrusion 1128 and the alignment end 1126. The opening 1130 may be sized and shaped or configured, for example, to receive a guide tube 630 for inserting a k-wire into a patient.
[0121] The base 1132 of the guide 1120 may include an alignment member 1134 extending in a first direction away from a first end of the base 1132. The alignment member 1134 may include a plurality of openings 1136 extending through the alignment member 1134 from a first side to a second side perpendicular to a length of the alignment member 1134. The openings 1136 may be sized and shaped or configured to receive, for example, a guide tube 630 for inserting a k-wire into a patient. The base 1132 may also include a mounting portion 614 also extending in a first direction away from a second end of the base 1132. The alignment member 1134 is disposed above the mounting portion 614. The mounting portion 614 has been described in more detail above and will not be described again here for brevity. The mounting portion 614 is configured to couple the guide 1120 to an insertion instrument 1030.
[0122] After the patient's bone has been prepared, a trial implant, such as trial implant 1000, may be coupled to an inserter 1030 and inserted into the prepared bone to determine the appropriate size implant 100, 450, 700, 850 to be used, as shown in FIG. 105. Imaging may be used to determine the location of the radiopaque markers 1020 on the trial implant 1000 while assessing the fit of the implant 100, 450, 700, 850. Once selected, the implant 100, 450, 700, 850 may be coupled to the inserter 1030 and inserted into the prepared bone. The implant 100, 450, 700, 850 may be, for example, implant 100, 450, 700, 850. Then, as shown in FIGS. 126-128, the precision guide 100, 450, 700, 850 may be coupled and used for cross-screw insertion after the implant 100, 450, 700, 850 has been inserted using an anterior approach.
[0123] 137-140, the patient's bone may be prepared and a trial implant, such as trial implant 1000, may be coupled to an inserter 1030 and inserted into the prepared bone to determine the appropriate size implant 100, 450, 700, 850 to be used, as shown in FIG. 137. Imaging may be used to determine the location of the radiopaque markers 1020 on the trial implant 1000 while assessing the fit of the implant 100, 450, 700, 850. Once selected, the implant 100, 450, 700, 850 may be coupled to the inserter 1030 and inserted into the prepared bone. The implant 100, 450, 700, 850 may be, for example, the implant 100, 450, 700, 850. Then, as shown in FIGS. 138-140, after the implant 100, 450, 700, 850 has been inserted using the lateral approach, a precision guide 1050 may be coupled and used for nail insertion.
[0124] 141-151, another precision guide 1140 is shown. The guide 1140 includes a body 1142 having a first end 1144 and a second end 1146. The guide 1140 includes a first alignment member 1148 disposed at and extending from the first end 1144. The first alignment member 1148 extends perpendicularly from the body 1142. The first alignment member 1148 has a plurality of openings 1150 extending from a first side to a second side of the first alignment member 1148. The plurality of openings 1150 may be, for example, three openings, although alternative numbers of openings 1150 are contemplated. The openings 1150 may be sized and shaped or configured to receive a guide tube 630 for inserting a k-wire into a patient, for example. The guide 1140 also includes an attachment portion 614 for coupling to the insertion instrument 1030. The attachment portion 614 is coupled to and extends from the body 1142 between a first end 1144 and a second end 1146. The attachment portion 614 has been described in more detail above and will not be described again here for brevity. The guide 1140 also includes a second alignment member 1152 coupled to and extending from the body 1142. The second alignment member 1152 is coupled to the body 1142 using a fastener 1156. The fastener 1156 engages a tab 1157 extending from a side of the second alignment member 1152. The second alignment member 1152 includes a plurality of openings 1154 extending through the second alignment member 1152 from a first side to a second side. The second alignment member 1152 may have, for example, a rectangular shape and may have openings 1154 evenly spaced across the member 1152. The second alignment member 1152 is disposed between the mounting portion 614 and the second end 1146 of the body 1142. The openings 1154 may be sized and shaped or configured to receive, for example, a guide tube 630 for inserting a k-wire into a patient.
[0125] 141-151 , the guide 1140 also includes a lower member 1158 extending from the second end 1146 of the body 1142. The lower member 1158 includes a first leg 1160 extending from the body 1142 in a direction perpendicular to the direction of the first and second alignment members 1148, 1152 and the mounting portion 614. The first leg 1160 extends from the body 1142 at an angle away from the body 1142. The lower member 1158 also has a second leg 1162 extending away from the second end of the first leg 1160. The second leg 1162 extends vertically from the first leg 1160 toward the first and second alignment members 1148, 1152 and the mounting portion 614 to position the alignment end 1164 above the members 1148, 1152 and the mounting portion 614. The alignment end 1164 is coupled to a second end of the second leg 1162. The alignment end 1164 can extend vertically away from the second leg 1162, for example. The alignment end 1164 can include a protrusion 1166 extending away from a bottom surface of the alignment end 1164. The protrusion 1166 can include a through hole 1168 extending through the protrusion 1166 and the alignment end 1164. The through hole 1168 may be sized and shaped or configured to receive a guide tube 630 for inserting a k-wire into a patient, for example.
[0126] 137 and 141-143, the patient's bone may be prepared and a trial implant, such as trial implant 1000, may be coupled to an inserter 1030 and inserted into the prepared bone to determine the appropriate size implant 100, 450, 700, 850 to be used, as shown in FIG. 137. Imaging may be used to determine the location of the radiopaque marker 1020 on the trial implant 1000 while assessing the fit of the implant 100, 450, 700, 850. Once selected, the implant 100, 450, 700, 850 may be coupled to the inserter 1030 and inserted into the prepared bone. The implant 100, 450, 700, 850 may be, for example, implant 100, 450, 700, 850. Then, as shown in FIGS. 141-143, the precision guide 100, 450, 700, 850 may be coupled and used for cross-screw insertion after the implant 100, 450, 700, 850 has been inserted using the lateral approach.
[0127] 152-155, the patient's bone may be prepared and a trial implant, such as trial implant 1000, may be coupled to an inserter 1030 and inserted into the prepared bone to determine the appropriate size implant 100, 450, 700, 850 to be used, as shown in FIG. 152. Imaging may be used to determine the location of the radiopaque markers 1020 on the trial implant 1000 while assessing the fit of the implant 100, 450, 700, 850. Once selected, the implant 100, 450, 700, 850 may be coupled to the inserter 1030 and inserted into the prepared bone. The implant 100, 450, 700, 850 may be, for example, the implant 100, 450, 700, 850. Then, as shown in Figures 153-155, after the implant 100, 450, 700, 850 has been inserted using a posterior approach, a precision guide 1050 may be coupled and used for nail insertion.
[0128] 156-166, another precision guide 1180 is shown. Guide 1180 includes a body 1186 having a first end 1182 and a second end 1184. Guide 1180 also includes an alignment member 1188 coupled to and extending from the first end 1182 of the body 1186. Alignment member 1188 extends in a first direction perpendicular to a portion of the body 1186. Guide 1180 also includes a mounting portion 614 extending from the body 1186. Mounting portion 614 extends from body 1186 between alignment member 1188 and second end 1184. Mounting portion 614 may be as described above with reference to guide 550 and will not be described again here for the sake of brevity.
[0129] The guide 1180 also includes an arm 1192 extending away from the second end 1184 of the body 1186 in a second direction perpendicular to the body 1186, alignment member 1188, and mounting portion 614. The arm 1192 includes an alignment end 1194 extending from the arm 1192 at an opposite end of the body 1186. The alignment end 1194 may, for example, extend perpendicularly away from the arm 1192. The alignment end 1194 may include a protrusion 1196 extending away from a top surface of the alignment end 1194. The protrusion 1196 may include a through hole 1198 extending through the protrusion 1196 and the alignment end 1194. The through hole 1198 may be sized and shaped or configured to receive a guide tube 630 for inserting a k-wire into a patient, for example.
[0130] The base 1132 of the guide 1120 may include an alignment member 1134 extending in a first direction away from a first end of the base 1132. The alignment member 1134 may include a plurality of openings 1136 extending through the alignment member 1134 from a first side to a second side perpendicular to a length of the alignment member 1134. The openings 1136 may be sized and shaped or configured to receive, for example, a guide tube 630 for inserting a k-wire into a patient. The base 1132 may also include a mounting portion 614 also extending in a first direction away from a second end of the base 1132. The alignment member 1134 is disposed above the mounting portion 614. The mounting portion 614 has been described in more detail above and will not be described again here for brevity. The mounting portion 614 is configured to couple the guide 1120 to an insertion instrument 1030.
[0131] 167-172, another trial implant 1200 is shown. The trial implant 1200 includes an outer surface 1202 having a rectangular shape, a top surface 1204, a bottom surface 1206, a front surface 1208, a rear surface 1210, a first side surface 1212, and a second side surface 1214. The trial implant 1200 includes an inserter opening 1008 recessed into the outer surface 1202 of the trial 1200. The inserter opening 1008 includes a recessed area 1010 extending into the trial 1200 from the outer surface 1202, and a through hole 1012 extending into the trial 1200 from an inner surface of the recessed area 1010. The through hole 1012 may be threaded to engage and couple with a threaded portion of an inserter 1030, for example. The recessed area 1010 may have a size larger than the size of the through hole 1012, for example, to receive the end of the inserter 1030. The trial product 1200 may also include a number of holes 1014 for receiving radiopaque markers 1016.
[0132] The present invention has been described with reference to preferred embodiments. It will be understood that the architectural and operational embodiments described herein are illustrative of multiple possible configurations for providing the same general features, characteristics, and general system operations. Modifications and alterations will occur to others upon reading and understanding the foregoing detailed description. It is intended that the present invention be construed to include all such modifications and alterations.
[0133] As can be recognized by those skilled in the art based on the teachings herein, numerous changes and modifications may be made to the above and other embodiments of the present disclosure without departing from the scope of the present disclosure. The components of the instruments, implants, and / or systems disclosed herein, including the accompanying abstract and drawings, may be replaced with alternative component(s) or feature(s), such as those disclosed in another embodiment, which serve the same, equivalent, or similar purpose, to achieve the same, equivalent, or similar result with such alternative component(s) or feature(s), as known to those skilled in the art, to provide similar functionality for the intended purpose. In addition, the instruments, implants, and / or systems may include more or fewer components or features than the embodiments described and illustrated herein. Thus, this detailed description of the presently preferred embodiments should be interpreted as illustrative, as opposed to restrictive, of the present disclosure.
[0134] When an element is referred to as being "on" another element, it will be understood that it can be directly on the other element or that there may be intervening elements between the elements. In contrast, when an element is referred to as being "directly on" another element, there are no intervening elements. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.
[0135] Terms such as first, second, third, etc. may be used herein to describe various elements, components, regions, layers, and / or portions, but it will be understood that these elements, components, regions, layers, and / or portions should not be limited by these terms. These terms are used only to distinguish one element, component, region, layer, and / or portion from another element, component, region, layer, and / or portion. Thus, a first element, component, region, layer, and / or portion described below can also be referred to as a second element, component, region, layer, and / or portion without departing from the teachings of the present disclosure.
[0136] The terms used herein are merely for the purpose of describing particular embodiments and are not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural unless the context clearly dictates otherwise. It will be further understood that the terms "comprises" and / or "comprising" or "includes" and / or "including" as used herein specify the presence of the stated features, regions, integers, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and / or groups thereof. The transitional term "comprising" encompasses the transitional terms "consisting of" and "consisting essentially of". The term and / or is used herein to mean both "and" and "or". For example, "A and / or B" is interpreted to mean A, B or A and B.
[0137] Furthermore, relative terms such as "lower" or "bottom" and "upper" or "top" may be used herein to describe the relationship of one element to another element illustrated in the figures. It will be understood that the relative terms are intended to encompass different orientations of the device in addition to the orientation depicted in the figures. For example, if a device in one of the figures is flipped over, an element described as being on the "lower" side of the other element would be oriented on the "upper" side of the other element. Thus, the exemplary term "lower" can encompass both an orientation of "lower" and "upper," depending on the particular orientation of the figure. Similarly, if a device in one of the figures is flipped over, an element described as being "below" or "beneath" the other element would be oriented "above" the other element. Thus, the exemplary terms "lower" or "beneath" can encompass both an orientation of upper and lower.
[0138] Exemplary embodiments are described herein with reference to cross-sectional views, which are schematic illustrations of idealized embodiments. Thus, variations from the shapes of the illustrations as a result of, for example, manufacturing techniques and / or tolerances, are to be expected. Thus, the embodiments described herein should not be construed as limited to the particular shapes of regions as illustrated herein, but should include, for example, deviations in shapes that result from manufacturing. For example, a region illustrated or described as flat may typically have rough and / or non-linear features. Additionally, sharp angles that are illustrated may be rounded. Thus, the regions illustrated in the figures are schematic in nature, and their shapes are not intended to illustrate the exact shapes of the regions, and are not intended to limit the scope of the claims.
[0139] Various numerical ranges are disclosed herein. These ranges include the endpoints, as well as the values between these endpoints. Values within these ranges are interchangeable.
[0140] The corresponding structures, materials, operations, and equivalents of all means-plus-function or step-plus-function elements in the following claims are intended to include any structures, materials, or operations to perform functions in combination with other specifically claimed claim elements, if any. The description of one or more embodiments has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the disclosed forms. Many modifications and variations will be apparent to those skilled in the art. The embodiments have been selected and described to best explain various aspects and practical applications and to enable those skilled in the art to understand various embodiments with various modifications suitable for the particular use contemplated.
Claims
1. An inner frame, an outer frame surrounding the inner frame, and a lattice structure extending between at least a part of the inner frame and the outer frame An implant comprising the above.
2. The inner frame is at least one first intermediate portion disposed on the upper surface of the implant, and a second intermediate portion disposed on the bottom surface of the implant The implant according to claim 1, comprising the above.
3. The implant according to claim 2, wherein the at least one first intermediate portion is not directly connected to the second intermediate portion.
4. The implant according to claim 2, wherein the at least one first intermediate portion is connected to the outer frame on the upper surface of the implant, and the second intermediate portion is connected to the outer frame on the bottom surface of the implant.
5. The at least one first intermediate portion is at least one first segment extending between a first side surface and a second side surface, and at least one second segment spaced apart from the at least one first segment by a first distance and extending between the first side surface and the second side surface The implant according to claim 4, comprising the above.
6. The implant according to claim 5, wherein a first end of the at least one first segment is connected to a first end of the at least one second segment by a first guide hole member, and a second end of the at least one first segment is connected to a second end of the at least one second segment by a second guide hole member.
7. The implant according to claim 6, wherein the first guide hole member is curved from the upper surface toward the bottom surface, and the second guide hole member is curved from the upper surface toward the bottom surface.
8. A first track extends through the first guide hole member on the upper surface, the implant, and the second intermediate portion on the bottom surface, and a second track extends through the second guide hole member on the upper surface, the implant, and the second intermediate portion on the bottom surface. The implant according to claim 7.
9. The implant according to claim 5, wherein the second intermediate portion has an oval shape with a length longer than the first distance between the at least one first segment and the at least one second segment of the at least one first intermediate portion.
10. The implant according to claim 4, wherein the at least one first intermediate portion and the second intermediate portion are connected to the outer frame by the lattice structure.
11. The at least one first intermediate portion is a first lobe disposed on a first side surface of the implant, a second lobe disposed on a second side surface of the implant, a first connection segment having a first end and a second end, wherein the first end of the first connection segment is connected to the first end of the first lobe, and the second end of the first connection segment is connected to the first end of the second lobe, and a second connection segment having a first end and a second end, wherein the first end of the second connection segment is connected to the second end of the first lobe, and the second end of the second connection segment is connected to the second end of the second lobe The implant according to claim 4, comprising.
12. The implant according to claim 11, wherein the first lobe is curved between the first connection segment and the second connection segment, and the second lobe is curved between the first connection segment and the second connection segment.
13. The implant according to claim 12, wherein the first lobe and the second lobe are in a horseshoe shape.
14. The implant according to claim 11, wherein the first lobe is disposed to curve along the circumference of the outer surface of the implant, and the second lobe is disposed to curve along the circumference of the outer surface of the implant.
15. The implant according to claim 11, wherein the first connection segment and the second connection segment are curved so as to be separated from each other when the first connection segment and the second connection segment extend between the first lobe and the second lobe.
16. The implant according to claim 11, wherein at least one track extends through the at least one first intermediate portion at the top of the implant and the second intermediate portion at the bottom of the implant.
17. The second intermediate portion is a body, a first lobe extending from a first portion of the body, and a second lobe extending from a second portion of the body The implant according to claim 16, comprising.
18. The implant according to claim 17, wherein the body has a circular shape.
19. The implant according to claim 17, wherein the first lobe is spaced apart from the second lobe, and the first lobe and the second lobe are disposed between a first side surface and a second side surface.
20. A first track is formed between the first lobe of the at least one first intermediate portion and the second lobe of the second intermediate portion, and a second track is formed between the second lobe of the at least one first intermediate portion and the first lobe of the second intermediate portion. The implant according to claim 19.
21. The implant according to claim 20, wherein the first track intersects the second track when the first track and the second track extend between the upper surface and the bottom surface of the implant.
22. The outer frame is a first side surface, a second side surface disposed on the opposite side of the first side surface, a third side surface extending between a first end of the first side surface and a first end of the second side surface, and a fourth side surface extending between a second end of the first side surface and a second end of the second side surface, wherein the third side surface is on the opposite side of the fourth side surface. The implant according to claim 2, comprising a fourth side surface The implant according to claim 2, comprising.
23. The outer frame is an upper surface extending between each first end of the first side surface, the second side surface, the third side surface, and the fourth side surface, and connected to each first end of the first side surface, the second side surface, the third side surface, and the fourth side surface; and a bottom surface extending between each second end of the first side surface, the second side surface, the third side surface, and the fourth side surface, and connected to each second end of the first side surface, the second side surface, the third side surface, and the fourth side surface. The implant according to claim 22, further comprising.
24. The first side surface includes at least one first window that penetrates the first side surface and extends from the outer surface of the first side surface into the interior of the implant, and the second side surface includes at least one second window that penetrates the second side surface and extends from the outer surface of the second side surface into the interior of the implant. The implant according to claim 22.
25. The at least one first window is two first windows of the same size and shape arranged as mirror images of each other on the first side surface, and the at least one second window is two second windows of the same size and shape arranged as mirror images of each other on the second side surface. The implant according to claim 24.
26. The third side surface includes at least one third window that penetrates the third side surface and extends from the outer surface of the third side surface into the interior of the implant, and the fourth side surface includes at least one fourth window that penetrates the third side surface and extends from the outer surface of the fourth side surface into the interior of the implant. The implant according to claim 24.
27. The at least one third window is two inner third windows arranged inside the third side surface, two outer third windows arranged outside the third side surface, and one distal third window arranged near the bottom of the third side surface between at least one of the two inner third windows and at least one of the two outer third windows The implant according to claim 26.
28. The at least one fourth window is two inner fourth windows arranged inside the fourth side surface, two outer fourth windows arranged outside the fourth side surface, and one distal fourth window arranged near the bottom of the fourth side surface between at least one of the two inner fourth windows and at least one of the two outer fourth windows The implant according to claim 27.
29. The third side surface is a first protrusion extending away from the inner surface of the third side surface, a first concave region extending from the outer surface into the third side surface, penetrating a part of the first protrusion, and extending toward the interior of the implant, and a first through hole extending through the first protrusion from the inner surface of the first concave region to the interior of the implant The implant according to claim 28.
30. The fourth side surface is A second protrusion extending away from the inner surface of the fourth side surface; A second concave region extending from the outer surface into the third side surface, passing through a portion of the second protrusion, and extending toward the interior of the implant; A second through-hole extending through the second protrusion from the inner surface of the second concave region to the interior of the implant; The implant according to claim 29, further comprising the above.
31. The implant according to claim 30, wherein the first concave region has a width and a height larger than those of the first through-hole, and the second concave region has a width and a height larger than those of the second through-hole.
32. The implant according to claim 31, wherein the first through-hole is threaded, and the second through-hole is threaded.
33. The implant according to claim 32, wherein the first through-hole and the second through-hole each have a non-circular shape.
34. A first passage is formed between the first end of the internal frame, the third side surface, a portion of the first side surface, and a portion of the second side surface, and at least a portion of the lattice structure is formed in the first passage. A second passage is formed between the second end of the internal frame, the fourth side surface, a portion of the first side surface, and a portion of the second side surface, and at least a portion of the lattice structure is formed in the second passage. The implant according to claim 22.
35. The outer frame is A plurality of connecting portions circumferentially spaced around the implant between the at least one first intermediate portion and the second intermediate portion; A plurality of arms connecting each of the plurality of connecting portions to each other, arranged in a circular shape between the plurality of connecting portions; The implant according to claim 2, comprising the above.
36. The plurality of connecting portions are A first connecting portion on the first side surface of the implant; A second connecting portion on the second side surface of the implant opposite to the first connecting portion; A third connecting portion on the third side surface of the implant between the first connecting portion and the second connecting portion; A fourth connecting portion on the fourth side surface of the implant opposite to the third connecting portion; The implant according to claim 35, comprising the above.
37. The plurality of arms are A first arm connecting the fourth connecting portion to the first connecting portion; A second arm for connecting the first connecting portion to the second connecting portion, A third arm for connecting the second connecting portion to the third connecting portion, A fourth arm for connecting the third connecting portion to the fourth connecting portion The implant according to claim 36, comprising:
38. The implant according to claim 37, wherein the connecting portion and the arm are connected to each other so as to form a ring disposed near the midpoint between the upper surface and the bottom surface of the implant.
39. The outer frame is A first cross member connected to the at least one first intermediate portion at a first end, to the second intermediate portion at a second end, and to the second arm near the midpoint of the first cross member; A second cross member connected to the at least one first intermediate portion at a first end, to the second intermediate portion at a second end, and to the third arm near the midpoint of the second cross member; A third cross member connected to the at least one first intermediate portion at a first end and to the second intermediate portion at a second end The implant according to claim 37, further comprising:
40. The third cross member is An upper portion connected to the at least one first intermediate portion at a first end and to the third connecting portion at a second end; A lower portion connected to the third connecting portion at a first end and to the second intermediate portion at the second end The implant according to claim 39, comprising:
41. The outer frame is Extending from the outer surface of the implant to the inner surface of the implant, and a plurality of openings disposed between the connecting portion, the arm, and the cross member The implant according to claim 40, further comprising:
42. The implant according to claim 41, wherein the lattice structure is formed within the plurality of openings.
43. An inner frame, An outer frame surrounding the inner frame, A lattice structure extending between at least a portion of the inner frame and the outer frame An implant comprising: An insertion instrument connected to the outer frame of the implant A system comprising:
44. The insertion instrument is A handle, An outer shaft connected to the handle at a first end, An inner shaft rotatably received within the outer shaft The system according to claim 43, comprising:
45. The outer shaft is A knob housing disposed between a first end and a second end of the outer shaft, the knob housing including an opening extending from a first side to a second side through the knob housing, the knob housing; A passage extending from the second end of the knob housing through the outer shaft to the opening; A guide attachment portion disposed on an outer surface of the outer shaft between the second end and the knob housing; The system according to claim 44, comprising:
46. The system according to claim 45, wherein the second end of the outer shaft includes at least one recessed region for engaging a portion of the implant.
47. The system according to claim 46, wherein the knob housing has a width, and the width of the knob housing is greater than a diameter of the outer shaft.
48. The insertion instrument, The knob having a through hole extending from a first end to a second end through the knob, the knob being rotatably disposed within the opening of the knob housing; The system according to claim 46, further comprising:
49. The system according to claim 48, wherein a first end of the inner shaft is inserted into the through hole of the knob and is connected to the knob.
50. The inner shaft, A through hole for connecting the inner shaft to the knob; An engaging end portion of the second end of the inner shaft, the engaging end portion being configured to be connected to the implant for insertion, and at least a portion of the engaging end portion extending beyond the second end of the outer shaft; The system according to claim 49, further comprising:
51. The system according to claim 50, wherein the engaging end portion is threaded.
52. The inner shaft, A groove inserted into the inner shaft above the engaging end portion adjacent to the engaging end portion; The system according to claim 50, further comprising:
53. The guide attachment portion, An engaging surface; A first protrusion disposed at a first end of the engaging surface and extending beyond the engaging surface; A second protrusion disposed at a second end of the engaging surface and extending beyond the engaging surface; The system according to claim 50, comprising:
54. The guide attachment portion, A hole extending within the engaging surface and disposed intermediate the first protrusion and the second protrusion; The system according to claim 53, further comprising
55. A guide removably connected to the insertion instrument The system according to claim 54, further comprising
56. The guide is An arm, A guide tube housed within the arm The system according to claim 55, comprising
57. The arm is A first part, A second part, A connecting part connected to the first part at a first end and to the second part at a second end, the connecting part angling the first part with respect to the second part The system according to claim 56, comprising
58. The first part is An alignment part extending in the first direction away from a first end of the first part, A through hole extending from the top surface to the bottom surface through the alignment part, the guide tube extending through the through hole The system according to claim 57, comprising
59. The second part is A mounting part for housing the guide mounting part of the insertion instrument, the mounting part extending away from a second end of the second part The system according to claim 58, comprising
60. The mounting part is A first leg disposed on the top surface of the mounting part, A second leg disposed on the bottom surface of the mounting part, the second leg extending parallel to the first leg from the second part, A channel extending from a second end of the mounting part into the mounting part between the first leg and the second leg The system according to claim 59, comprising
61. The first leg is A through hole extending from the top surface of the mounting part through the first leg to the channel The system according to claim 60, comprising
62. For fixing the guide to the insertion instrument, a pin is inserted through the through hole of the first leg of the guide into the hole of the guide mounting part, the system according to claim 61
63. The guide tube is A head, A shaft having a first end connected to the head, A cannula extending from the first end to the second end through the guide tube The system according to claim 62, comprising
64. The guide is A frame, A guide tube housed within the frame, At least one angled wing housed within the frame and The system according to claim 55, comprising.
65. The frame is A base member, A foot portion connected to a second end of the base member and extending in a first direction away from the second end of the base member, An arm connected to a first end of the base member and extending away from the first end of the base member, An attachment portion extending away from the base member The system according to claim 64, comprising.
66. The foot portion is A first foot portion, wherein a first end of the first foot portion is connected to the second end of the base member, A foot connector having a first end and a second end, wherein the first end is connected to a second end of the first foot portion, A second foot portion, wherein a first end of the second foot portion is connected to the second end of the foot connector The system according to claim 65, comprising.
67. The foot portion is A sleeve connected to a second end of the second foot portion and extending from the second end of the second foot portion, the sleeve including a through hole for receiving the guide tube The system according to claim 66, further comprising.
68. The sleeve is A channel extending from an outer surface of the sleeve to the through hole along a longitudinal axis of the sleeve The system according to claim 67, further comprising.
69. The attachment portion is A first leg portion extending from the base member in the first direction, A second leg portion extending from the base member in the first direction and spaced apart from the first leg portion, A channel extending within the attachment portion between the first leg portion and the second leg portion The system according to claim 68, comprising.
70. The first leg portion is A through hole extending through the first leg portion from an upper surface of the attachment portion to the channel The system according to claim 69, comprising.
71. In order to fix the guide to the insertion instrument, a pin is inserted into the hole of the guide attachment portion through the through hole of the first leg portion of the guide, the system according to claim 70.
72. The arm is A first arm portion having a first end and a second end, wherein the first arm is connected to the first end of the base member between the first end and the second end of the first arm. The first arm portion, An arm connector having a first end and a second end, wherein the first end of the arm connector is connected to the second end of the first arm portion. The arm connector, A second arm portion having a first end and a second end, wherein the first end of the second arm portion is connected to the second end of the arm connector, and the arm connector positions the first arm portion angled with respect to the second arm portion. The second arm portion The system according to claim 71, comprising:
73. The arm is A first alignment portion extending away from the upper surface of the first arm portion at the first end of the first arm portion. A second alignment portion extending away from the upper surface of the second arm portion at the second end of the second arm portion. The system according to claim 72, further comprising:
74. The first alignment portion includes a first opening extending from the upper surface to the bottom surface of the first alignment portion into the first alignment portion, and the first opening receives a first angle wing of the at least one angle wing. The system according to claim 73.
75. The second alignment portion includes a second opening extending from the upper surface to the bottom surface of the second alignment portion into the second alignment portion, and the second opening receives a second angle wing of the at least one angle wing. The system according to claim 74.