WO2024257101A1

WO2024257101A1 - Methods and apparatus for hip resurfacing and hip replacement procedure using a guiding jig

Info

Publication number: WO2024257101A1
Application number: PCT/IL2024/050582
Authority: WO
Inventors: Amit ZABTANI; Or BENIFLA
Original assignee: Sheba Impact Ltd
Current assignee: Sheba Impact Ltd
Priority date: 2023-06-12
Filing date: 2024-06-11
Publication date: 2024-12-19
Anticipated expiration: 2025-12-12
Also published as: WO2024257100A3; WO2024257102A1; WO2024257100A2

Abstract

The present invention, in some embodiments thereof, relates to a surgical guiding joint integration group (JIG) and, more particularly, but not exclusively, to a surgical guiding JIG to be used on the femur head and/or neck.

Description

METHODS AND APPARATUS FOR HIP RESURFACING AND HIP REPLACEMENT

PROCEDURE USING A GUIDING JIG

RELATED APPLICATION/S

This application claims the benefit of priority of U.S. Provisional Patent Application No. 63/472,397 filed on June 12, 2023, U.S. Provisional Patent Application No. 63/472,392 filed on June 12, 2023, and U.S. Provisional Patent Application No. 63/472,602 filed on June 13, 2023 the contents of which are incorporated herein by reference in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

Additional background art includes scientific publication “a custom-made guide-wire positioning device for Hip Surface Replacement Arthroplasty: description and first results ”, by Raaijmaakers, Martijn, et al. disclosing that “...Pilot testing of a custom made jig for use during SRA indicated that the device was (1) successfully applied and user friendly and (2) allowed for accurate guide wire placement according to the preoperative plan.”.

SUMMARY OF THE INVENTION

Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multipel examples, also if not expressly listed below.

Example 1. A guiding JIG for use during hip resurfacing, comprising: a. a JIG body, shaped and sized to be mounted on the femur head; b. a guiding conduit positioned on the JIG body and defining a path into the center of the femur head; and c. an osteotomy guide positioned on the JIG body and defining a path for cutting the femur head.

Example 2. The guiding JIG according to example 1, wherein the guiding conduit directs a guide implement.

Example 3. The guiding JIG according to example 1 or example 2, wherein the guiding conduit has cylindrical shape to receive a guide implement, having diameter less than 2 mm. Example 4. The guiding JIG according to any one of example 1-3, wherein cutting using the guide osteotomy results in a truncated shape of the femur head; and wherein said truncated shape fits steady within a hip resurfacing implant.

Example 5. The guiding JIG according to any one of example 1-4, wherein the guide osteotomy comprises a cutting slot.

Example 6. The guiding JIG according to example 5, wherein the guide osteotomy comprises a cutting slot for a saw.

Example 7. The guiding JIG according to example 6, wherein the saw is 1.1mm thick.

Example 8. The guiding JIG according to any one of example 1-7, wherein the JIG body comprises inner surface having a geometry which complements the geometry of the femur head of the patient, at the treatment site.

Example 9. The guiding JIG according to any one of example 1-8, wherein the JIG body at least partially surrounds the femur head.

Example 10. The guiding JIG according to example 9, wherein the JIG body has a grip on the femoral head.

Example 11. A method for performing hip resurfacing procedure on a femur head using a single guiding JIG, said single guiding JIG comprising: a. a JIG body, shaped and sized to be mounted on the femur head; b. a guiding conduit positioned on the JIG body and defining a path into the center of the femur head; and c. an osteotomy guide positioned on the JIG body and defining a path for cutting the femur head; said method comprising: d. mounting the guiding JIG on the femur head; e. inserting a guide implement into the center of the femur head through guiding conduit for a guide implement; f. cutting the femoral bone through a cutting slot, using the selected cutting tool, to create a bone portion separating from the femur head.

Example 12. The method according to example 11, wherein the JIG body further comprises an inner surface having geometry which completes the geometry of the femur head; and wherein the method further comprises aligning the guiding JIG on the femur head by fitting the geometry of the inner surface of the JIG with the geometry of the femur head.

Example 13. A guiding JIG for use on a femur head, comprises: a. a JIG body; and b. an osteotomy guide, on the JIG body, comprises: i. a cutting slot, shaped and sized to receive a selected cutting tool; ii. a frame defining the cutting slot; wherein the cutting slot directs the selected cutting tool to cut the femoral bone in a desired path, and wherein a location of the cutting slots defines a location for the osteotomy.

Example 14. The guiding JIG according to example 13, wherein the location of guide osteotomy defined by a selected implant and by the femur anatomy of the patient.

Example 15. The guiding JIG according to example 13 or example 14, wherein the cutting slot defining a path to cut the femur head, away from the femur neck.

Example 16. The guiding JIG according to any one of examples 13-15, wherein the guiding JIG is used for hip resurfacing procedure.

Example 17. The guiding JIG according to any one of examples 13-16, wherein the selected implant is an implant for hip resurfacing procedure.

Example 18. The guiding JIG according to any one of examples 13-17, wherein the cutting slot defining a path to cut the femur neck and/or to cut the femur head at proximity to the femur neck.

Example 19. The guiding JIG according to any one of examples 13-18, wherein the guiding JIG is used for hip replacement procedure.

Example 20. The guiding JIG according to any one of examples 13-19, wherein the selected implant is an implant for hip replacement procedure.

Example 21. A method for designing a guiding JIG, comprising: a. creating a patient specific 3D simulation of the femur head; b. identifying features of the femur head; c. creating a footprint; and d. designing guiding elements.

Example 22. The method according to example 21, wherein the patient specific 3D simulation of the femur head is based on a scan image of the femur head.

Example 23. The method according to example 21 or example 22, wherein features of the femur head comprises the femur neck.

Example 24. The method according to any one of examples 21-23, wherein features of the femur head comprises the femoral neck-head axis.

Example 25. The method to any one of examples 21-24, wherein said method further comprises further thickening the footprint to represent a JIG body. Example 26. The method to any one of examples 21-25, wherein said method further comprises positioning the guiding elements on the footprint, each defining a path thereinto.

Example 27. The method to any one of examples 21-26, wherein the guiding elements comprises one or more of: a. a guiding conduit for guide implement; and b. an osteotomy guide comprises a cutting slot, shaped and sized to receive a cutting tool.

Example 28. The method according to example 26, wherein said positioning the guiding conduit for a guide implement comprises positioning in-line with the femoral neck-head axis, and protruding from the bone.

Example 29. The method according to example 26, wherein said positioning comprises positioning a cutting slot perpendicular to the femoral neck-head axis.

Example 30. The method according to example 29, wherein locating the cutting slot on the femur head, in a distance from the femur neck.

Example 31. The method according to any one of examples 21-30, further comprising using the guiding JIG during hip resurfacing procedure.

Example 32. The method according to example 29, further comprising positioning the cutting slot on the femur neck and/or in proximity to the femur neck.

Example 33. The method according to any one of examples 21-32, further comprising using the guiding JIG during hip replacement procedure.

Example 34. The method according to any one of examples 21-33, further comprising receiving an input from a physician.

Example 35. The method according to example 34, wherein the input from the physician comprises a selected implant, which defines the location of a cutting slot along the femoral neckhead axis.

Example 36. A guiding JIG for use during hip replacement, comprising: a. a JIG body, shaped and sized to be mounted on the femur neck; b. an osteotomy guide positioned on the JIG body and defining a path for cutting the femur head.

Example 37. The guiding JIG according to example 36, wherein the guide osteotomy comprises a cutting slot for a saw.

Example 38. The guiding JIG according to example 37, wherein the saw is 1.1mm thick, defining a cutting slot of 3.5 mm.

Example 39. A guiding JIG for use during hip resurfacing, comprising: a. a JIG body, shaped and sized to be mounted on the femur head; b. a guiding conduit positioned on the JIG body and defining a path into the center of the femur head; and c. at least one osteotomy guide positioned on the JIG body and defining a path for cutting the femur head.

Example 40. The guiding JIG according to example 39, wherein the guiding conduit is sized and shaped to receive and direct a guide implement.

Example 41. The guiding JIG according to example 39 or 40, wherein the guiding conduit comprises a slit extending along a wall of said conduit, from a proximal end of said wall, facing away from a femur neck, to a distal end of said wall, facing toward a femur neck, and ends at a portion of said wall not connected to the JIG body.

Example 42. The guiding JIG according to any of examples 39-41 , wherein the guide osteotomy comprises a cutting slot.

Example 43. The guiding JIG according to any of examples 39-42 , wherein the guide osteotomy comprises a supporting frame.

Example 44. The guiding JIG according to example 43, wherein said frame comprises at least one sturdy surface, positioned therewithin.

Example 45. The guiding JIG according to any of examples 39-44 , wherein the JIG body comprises an inner surface having a geometry which complements the geometry of the femur head of the patient, at the treatment site.

Example 46. The guiding JIG according to any of examples 39-45 , wherein the JIG body at least partially surrounds the femur head.

Example 47. The guiding JIG according to any of examples 39 to 8 , wherein the JIG body has a grip on the femoral head.

Example 48. The guiding JIG according to any of examples 39-47 , wherein the JIG body at least partially covers the femur neck.

Example 49. The guiding JIG according to any of examples 39-48 , comprising a measurable mark, designed to have a specific size and shape, configured to be measured to indicate that said guiding JIG is produced according to a desired design.

Example 50. A guiding JIG deployable in parts on a bone, comprising: a. a JIG body comprising more than one JIG parts, shaped and sized to be mounted on the bone; and b. at least one guiding element positioned on the JIG body.

Example 51. The guiding JIG according to example 50, wherein more than one JIG part comprises a first JIG part and a second JIG part, wherein said first JIG part comprises an inner surface having a geometry that complements the geometry of bone at the treatment site, and wherein said second JIG part configured to be aligned with the first JIG part.

Example 52. The guiding JIG according to example 51, wherein said second JIG part comprises an an inner surface having a geometry that complements the geometry of bone at the treatment site.

Example 53. The guiding JIG according to example 51, wherein said first JIG part comprises a first geometry that interacts with a second geometry of said second JIG part; wherein said first geometry and said second geometry are complementary to each other.Example 54.

The guiding JIG according to any of example 53, wherein said first geometry comprises one or more protrusions and wherein said second geometry comprises one or more recesses shaped and sized to accommodate said one or more protrusions.

Example 55. The guiding JIG according to any of examples 53-54, wherein said first geometry comprises one or more recesses and wherein said second geometry comprises one or more protrusions shaped and sized to occupy said one or more protrusions.

Example 56. The guiding JIG according to any of examples 50-55, at least one guiding element comprises one or more of: at least one guiding conduit shape and sized to direct a guide implement into the bone and at least one osteotomy guide, sized and shaped to direct a cutting tool into the bone.

Example 57. The guiding JIG according to example 56, wherein said at least one guiding conduit is positioned on the JIG body, defining a path into the center of the femur head, and wherein said at least one osteotomy guide is positioned on the JIG body defining a path for cutting the femur head or neck.

Example 58. The guiding JIG according to any of examples 50 -57, wherein the bone is a femur head and the JIG is designed for a hip resurfacing procedure.

Example 59. The guiding JIG according to any of examples 50-57, wherein the bone is a femur neck and the JIG is designed for a hip replacement procedure.

Example 60. A guiding JIG having an adjustable osteotomy guide, comprising: a. a JIG body, shaped and sized to be mounted on a bone; and b. at least one osteotomy guide, comprising a first cutting surface and a second cutting surface, defining a cutting slot therebetween, wherein at least one of said first cutting surface or said second cutting surface is removable.

Example 61. The guiding JIG according to example 60, wherein the JIG body comprises more than one JIG portion, wherein more than one JIG portion comprises a first JIG portion comprises said first cutting surface and a second JIG portion comprises said second cutting surface, wherein one of said first JIG portion or said second JIG portion is removable.

Example 62. The guiding JIG according to example 61, wherein said first JIG portion is removable and comprises one or more grip holes, wherein said one or more grip holes are shaped and sized to accommodate a gripping tool.

Example 63. The guiding JIG according to example 62, wherein said second JIG portion comprises at least one fixating guide, sized and shaped for directing a fixator therethrough into the bone.

Example 64. The guiding JIG according to any of examples 60-63, comprising at least one detachable connection point between said first cutting surface and said second cutting surface.

Example 65. The guiding JIG according to example 64, wherein said at least one detachable connection point is defined by a sliding pin of said first cutting surface and a groove of said second cutting surface, wherein said groove is sized and shaped to receive the sliding pin and includes an opening that allows the sliding pin to exit therefrom upon movement.

Example 66. A guiding JIG for use during hip resurfacing or hip replacement procedure, comprising: a. a JIG body, shaped and sized to be mounted on the femur head; b. a plurality of osteotomy guides positioned on the JIG body wherein each osteotomy guide of said plurality of osteotomy guides defines a path for cutting the femur head.

Example 67. The guiding JIG according to example 66, wherein said plurality of osteotomy guides is in the form of a plurality of cutting slots

Example 68. The guiding JIG according to example 66, wherein said plurality of osteotomy guides are in the form of a plurality of a pair of tubular guiding conduits.

Example 69. The guiding JIG according to any of examples 66-68, comprising a guiding conduit positioned on the JIG body and defining a path into the center of the femur head.

Example 70. A method for performing a hip resurfacing procedure on a femur head using a single guiding JIG, wherein said single guiding JIG comprises: a. a JIG body, shaped and sized to be mounted on the femur head; b. a guiding conduit positioned on the JIG body and defining a path into the center of the femur head; and c. an osteotomy guide positioned on the JIG body and defining a path for cutting the femur head; said method comprising: d. mounting the guiding JIG on the femur head; e. inserting a guide implement into the center of the femur head through guiding conduit for a guide implement; f. cutting the femoral bone through a cutting slot, using the selected cutting tool, to create a bone portion separating from the femur head.

Example 71. The method according to example 70, wherein the JIG body further comprises an inner surface having geometry which completes the geometry of the femur head; and wherein the method further comprises aligning the guiding JIG on the femur head by fitting the geometry of the inner surface of the JIG with the geometry of the femur head.

Example 72. A method for designing a guiding JIG, comprising: a. creating a patient specific 3D simulation of the femur head; b. identifying features of the femur head; c. creating a footprint; and d. designing guiding elements.

Example 73. The method according to example 72, wherein the patient- specific 3D simulation of the femur head is based on a scan image of the femur head.

Example 74. The method according to example 72 or example 73, wherein said identifying comprises identifying the femur neck.

Example 75. The method according to any of examples 72-74 , wherein said identifying comprises identifying the femoral neck-head axis.

Example 76. The method according to any of examples 72 to 37 , further comprising thickening the footprint to represent a JIG body.

Example 77. The method accoding to any of examples 72-76, further comprising positioning the guiding elements on the footprint, each defining a path thereinto.

Example 78. The method according to any of examples 72 to 39 , wherein said designing comprises designing one or more of: a. a guiding conduit for guide implement; and b. an osteotomy guide comprises a cutting slot, shaped and sized to receive a cutting tool.

Example 79. The method according to example 77, wherein said positioning the guiding conduit for a guide implement comprises positioning in-line with the femoral neck-head axis, and protruding from the bone.

Example 80. The method according to example 77 or example 79, wherein said positioning comprises positioning a cutting slot perpendicular to the femoral neck-head axis.

Example 81. The method according to any to example 80, wherein said positioning locating the cutting slot on the femur head, at a distance from the femur neck. Example 82. The method according to example 80, further comprising positioning the cutting slot on the femur neck and/or in proximity to the femur neck.

Example 83. The method according to any of examples 72-82 , further comprising receiving an input from a physician.

Example 84. The method according to example 83, wherein the input from the physician comprises a selected implant, which defines the location of a cutting slot along the femoral neckhead axis.

Example 85. The method according to any of examples 72-84, further comprises positioning at least one measurable geometry on the JIG.

Example 86. A guiding JIG, for femur head or neck surgery, obtained by a process comprising: a. creating a patient-specific 3D simulation of the femur head; b. identifying features of the femur head in the simulation; c. creating a footprint based on the identified features; and d. designing guiding elements that are integrated into the guiding jig based on the footprint; and e. producing the guiding JIG.

Example 87. The guiding JIG according to example 86, wherein said identifying comprises identifying the femur neck and the femoral neck-head axis.

Example 88. The guiding JIG according to example 86 or example 87, wherein said designing comprises designing one or more of at least one guiding conduit for a guide implement, and at least an osteotomy guide comprises a cutting slot, shaped and sized to receive a cutting tool.

Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

As will be appreciated by one skilled in the art, some embodiments of the present invention may be embodied as a system, method or computer program product. Accordingly, some embodiments of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a “circuit,” “module” or “system.” Furthermore, some embodiments of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon. Implementation of the method and/or system of some embodiments of the invention can involve performing and/or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of some embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware and/or by a combination thereof, e.g., using an operating system.

For example, hardware for performing selected tasks according to some embodiments of the invention could be implemented as a chip or a circuit. As software, selected tasks according to some embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to some exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data. Optionally, a network connection is provided as well. A display and/or a user input device such as a keyboard or mouse are optionally provided as well.

Any combination of one or more computer readable medium(s) may be utilized for some embodiments of the invention. The computer readable medium may be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium may be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium would include the following: an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium may be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

A computer readable signal medium may include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal may take any of a variety of forms, including, but not limited to, electromagnetic, optical, or any suitable combination thereof. A computer readable signal medium may be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

Program code embodied on a computer readable medium and/or data used thereby may be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

Computer program code for carrying out operations for some embodiments of the present invention may be written in any combination of one or more programming languages, including an object-oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider).

Some embodiments of the present invention may be described below with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks. The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

Some of the methods described herein are generally designed only for use by a computer, and may not be feasible or practical for performing purely manually, by a human expert. A human expert who wanted to manually perform similar tasks, such as designing a JIG, might be expected to use completely different methods, e.g., making use of expert knowledge and/or the pattern recognition capabilities of the human brain, which would be vastly more efficient than manually going through the steps of the methods described herein.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

In the drawings:

Figures 1A-C are perspective views of a guiding JIG for a hip resurfacing procedure, in accordance with some exemplary embodiments of the invention;

Figure ID is a rear view of a guiding JIG for a hip resurfacing procedure, in accordance with some exemplary embodiments of the invention;

Figure 2A-C are perspective views of a guiding JIG for a hip replacement procedure, in accordance with some exemplary embodiments of the invention;

Figure 3 is a concise flowchart describing the design of a guiding JIG, in accordance with some exemplary embodiments of the invention;

Figures 4A-B are flowchart describing the identification of the femoral neck-head axis, in accordance with some exemplary embodiments of the invention;

Figure 5 is a flowchart describing the creation of a footprint for hip resurfacing guiding JIG, in accordance with some exemplary embodiments of the invention;

Figures 6A-C are flowchart describing the design of guiding elements for hip resurfacing guiding JIG, in accordance with some exemplary embodiments of the invention; Figure 7 is a flowchart describing the creation of a footprint for hip replacement guiding JIG, in accordance with some exemplary embodiments of the invention;

Figures 8A-B are a flowchart describing the design of guiding elements for hip replacement guiding JIG, in accordance with some exemplary embodiments of the invention.

Figures 9A-G are illustrations of the identification of the femoral neck-head axis, in accordance with some exemplary embodiments of the invention;

Figures 10A-C are illustrations of the footprint creation, for hip resurfacing guiding JIG, in accordance with some exemplary embodiments of the invention;

Figures 11A-C are illustrations of the footprint creation, for hip replacement guiding JIG, in accordance with some exemplary embodiments of the invention;

Figures 12A-G are illustrations of designing guiding elements for hip resurfacing guiding JIG, in accordance with some exemplary embodiments of the invention;

Figures 13A-C are illustrations of designing guiding elements for hip replacement guiding JIG, in accordance with some exemplary embodiments of the invention;

Figure 14 is a flowchart describing a workflow of a surgeon using guiding JIG during hip resurfacing procedure, in accordance with some exemplary embodiments of the invention;

Figure 15 is a flowchart describing a workflow of a surgeon using guiding JIG during hip replacement procedure, in accordance with some exemplary embodiments of the invention;

Figures 16A-B are perspective views of guiding JIG having more than one osteotomy guide for a hip resurfacing procedure, in accordance with some exemplary embodiments of the invention;

Figures 17A-B are perspective views of guiding JIG 1700 having more than one osteotomy guide for a hip resurfacing procedure, in accordance with some exemplary embodiments of the invention;

Figures 18A-C are perspective views of guiding JIG 1800 deployable in parts, in accordance with some exemplary embodiments of the invention;

Figures 19A-B are perspective views of a disassemblable guiding JIG 1900 for a hip replacement procedure, in accordance with some exemplary embodiments of the invention;

Figures 20A-C are perspective views of a disassemblable guiding JIG 2000 for a hip replacement procedure, in accordance with some exemplary embodiments of the invention;

Figures 21A-C are perspective views of a guiding JIG 2100 having a sturdy guiding element, in accordance with some exemplary embodiments of the invention;

Figure 2 ID is a perspective view of a sturdy surface(s) for a guiding JIG, in accordance with some exemplary embodiments of the invention; Figure 2 IE, is a view of a sturdy surface(s) before being folded to achieve a three- dimensional form of the sturdy surface(s), in accordance with some exemplary embodiments of the invention;

Figure 22 is a front view of an exemplary guiding JIG for plate fixation of distal radius fracture, in accordance with some exemplary embodiments of the invention; and

Figures 23A-B, are perspective views of a guiding JIG 2300 for osteotomy and resection surgeries (e.g., orthopedic oncology),.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

As used herein the terms “Guiding JIG” and/or “Surgical navigator” and/or “Surgical guide” and/or “patient- specific instrument (PSI) means a “Surgical JIG”.

Overview

An aspect of some embodiments of the invention relates to a single surgical navigator for insertion into a location within the femur head, for example, the center of the femur head and/or for cutting along the femoral neck-head axis of the femur head. In some embodiments, the cut is directed to the femur head, optionally, for a hip resurfacing procedure. In some embodiments, the cut is directed to the femur head, optionally, for a hip replacement procedure. In some embodiments, the surgical navigator includes a passageway directing a selected guide into the center of the femur head, optionally in a single desired pathway, alternatively or additionally, in a range of desired pathways. In some embodiments, the surgical navigator comprises a recess for a cutting tool directing a selected cutting tool into the femur head and/or femur neck, optionally in a single desired pathway, alternatively or additionally, in a range of desired pathways. In some embodiments of the invention, the surgical navigator is patient-specific. In some embodiments, the surgical navigator conforms to the bone geometry, optionally, a surface of the surgical navigator fits onto the femur head, optionally in a single steady configuration. In some embodiments, the single surgical navigator may direct the insertion of a guide tool into the femur head in any desired path and/or from any desired insertion location. As previously noted, in common practice the desired insertion path within the femur head is along a axis defining the central of the femur head (e.g., femoral neck-head axis), optionally, based on input from a surgeon. However, in some embodiments, another path is required. For example, the patient's congenital bone structure, previous treatments and/or implants, damage, and/or injuries to the bone may require an insertion path other than along said axis. In another example, a structure of a selected implant structure may require another insertion path than along said axis.

In some embodiments, the required insertion path through the bone and/or insertion point over the bone is required by the patient’s physician, alternatively or additionally, said required insertion path and/or said insertion point is recommended by a computer program (optionally, comprises a ML component) which evaluate the bone structure (e.g., the bone Image, such as a CT scan) and offers a path therewithin. An aspect of some embodiments of the invention relates to a surgical navigator used for cutting the femur head and/or neck. In some embodiments, the surgical navigator has a recess for cutting the bone therethrough. In some embodiments, the recess is positioned to direct a cutting tool to cut on the femur head, resulting in truncating the femur head. Alternatively or additionally, the recess is positioned to direct a cutting tool to cut the femur neck, resulting in the removal of the femur head. An aspect of some embodiments of the invention relates to a surgical navigator that allows and/or simplifies the removal thereof without removing a tool (e.g., a guide tool and/or an operating tool) deposited therewithin and inserted into the bone, from the bone.

In some embodiments, the surgical navigator comprises a passageway for directing a guide tool into a bone, and a wall defining said passageway. In some embodiments, a first end (e.g., first opening) of the wall is facing an operator, and a second end (e.g., second opening) is partially connected and/or partially positioned on the body of the surgical navigator. This partial positioning allows a portion of the wall and/or a portion of the wall’s second end to be free of the surgical navigator’s body. In some embodiments, the wall comprises a slit and/or a cut extending from said first end to said free portion of the second end, allowing the wall to be opened and passing a guide tool inserted within the bone therethrough. In some embodiments, the wall is provided with said slit. Alterantively or additionally said slit is formed after inserting the guide tool through the passageway. In some embodiments, the wall comprises a line and/or an area designated to be cut/opened. Alternatively or additionally, the wall comprises marking for directing the formation of the slit.

In some embodiments, the slit is relatively wide, defining an opening on the wall for a tool to pass therethrough. In some embodiments, the opening is sufficiently small to maintain the passageway defined by the wall.

In some embodiments, the surgical navigator is designed such that the wall is positioned near and/or at an edge of the surgical navigator’s body, allowing the formation of said free portion. This configuration has the potential advantage of facilitating the removal of the surgical navigator. Alternatively or additionally, the body comprises an opening and/or a gap, located next to said free portion, allowing the free portion to be free (e.g., unconnected) to the surgical navigator’s body. This configuration has the potential advantage of enabling the wall to be positioned at any desired location on the surgical navigator body.

In some embodiments, the tool remaining within the bone can be further used. For example, a guide tool inserted within a femur head may be used for loading a cylinder cutter thereon, for example, as commonly performed during hip resurfacing procedures. In another example, a guide tool inserted within a femur head may be used for mounting a chisel thereon, for example, as commonly performed during VDRO procedures.

In some embodiments, the surgical navigator’s body is configured to be cut and/or torn around the inserted tool. In some embodiments, the body comprises lines and/or areas of thin material and/or spaced holes for directing and/or facilitating said cut and/or teat. In some embodiments, such lines and/or areas are marked for directing an operator while cutting the surgical navigator.

In some embodiments, the surgical navigator is comprised of segments, such that the connection of the segments forms the wall. For example, in some embodiments, each segment includes a part of the wall, and when the segments interface, the wall is assembled. After introducing a tool via the wall into the bone, the segments can be disconnected, disassembling the wall and freeing the tool from the surgical navigator (e.g., during the removal of the surgical navigator) while the tool remains inserted within the bone.

An aspect of some embodiments of the invention relates to a surgical navigator for performing osteotomy on a bone, defining a plurality (e.g., more than one) cutting paths within the bone, optionally, for an operator to select from.

In some embodiments, the surgical navigator comprises one or more osteotomy guides, wherein each osteotomy guide comprises a plurality of recesses (e.g., cutting slots) for directing a cutting tool therethrough. Each recess defines a different path into the bone, optionally, a single pathway.

In some embodiments, the surgical navigator comprises a plurality of passageways, each defining a different location on the bone and guiding a tool into the bone that is used as a mark for performing osteotomy, optionally by using an additional surgical navigator that defines a cutting angle at the marked location. A surgical navigator comprising a plurality of passageways has the potential advantage or reducing and/or avoiding impairment of the mechanical strength of the surgical navigator while enabling path selection. In some embodiments, the surgical navigator comprises at least one recess and at least one passageway. For example, a recess defining a desired path into the bone and one or more passageways as alternatives, if needed.

In some embodiments, the surgical navigator comprises a plurality of recesses and/or passageways for directing osteotomy on the femur head and/or neck, for example during hip resurfacing and/or hip replacement procedure.

An aspect of some embodiments of the invention relates to a surgical navigator sturdy upon contact with sharp objects, such as sharp tools (guide tools and/or working tools), and/or sharp bone residues. In some embodiments, the surgical navigator comprises a passageway for directing a guide tool and/or a fixator (such as a screw and/or a k-wire) and/or a recess for directing a cutting tool, defined by a wall. In some embodiments, the wall is sturdy when contacted by a sharp object, optionally introduced thereinto. The term “sturdy” referres to herein, inter alia, as being resistant and/or substantially resistant to cuts, scratches and/or any other damage from contact with a sharp object. It should be noted that the term “sturdy” does not limit the material, properties and/or structure of the wall. For example, in some embodiments, the wall can comprise and/or be formed from a rigid material, alternatively or additionally, the wall can comprise and/or be formed from a resilient material, optionally soft material.

In some embodiments, the wall comprises a sturdy element, such as one or more sturdy surfaces deployed therewithin. In some embodiments, the one or more sturdy surfaces conform to the shape of the wall’s inner surface. In some embodiments the one or more sturdy surfaces comprises and/or formed of a metal, such as stainless steel. In some embodiments, one or more surfaces are flat, to potentially fit within a wall defining a recess for a cutting tool. In some embodiments, one or more surfaces are tubular, to potentially fit within a wall defining a passageway for a guide tool

An aspect of some embodiments of the invention relates to a surgical navigator mountable on a bone in parts and/or steps. In some embodiments, the surgical navigator is comprised of more than one segment where at least one segment is configured to be positioned on the bone, and at least one additional segment is configured to be positioned on the bone by connecting and/or interfacing with the at least one segment. In some embodiments, the at least one segment comprises an inner surface that fits steady on the bone surface, optionally, by having a geometry that complements the surface geometry of the bone. In some embodiments, the at least one additional segment comprises one or more geometry that can interact with (e.g., connect to) a corresponding geometry on the at least one segment. Mounting first the at least one segment and then the at least one additional segment potentially simplifies the deployment of the surgical navigator, having a particular use for relatively large surgical navigators. In some embodiments, the at least one additional segment comprises an inner surface having a geometry that complements the surface geometry as well. Mounting the segments in steps has the potential advantage of simplifying the match between the surgical navigator and the bone, having a particular use for relatively large surgical navigators.

An aspect of some embodiments of the invention relates to an adjustable osteotomy guide, for directing bone osteotomy. In some embodiments, the osteotomy guide comprises two cutting surfaces defining a recess therebetween for introducing a cutting tool therethrough. In some embodiments, the two surfaces are connected, optionally to form a frame. The recess is located and/or oriented on the surgical navigator for directing a cutting tool in a desired path into the bone, optionally, a single path. In some embodiments, the distance between the two surfaces is sufficient to enable the entrance of a cutting tool but small enough to avoid lateral movements thereof.

During surgery, the need to increase the degrees of freedom of the operator and/or to improve its access to the bone may arise. In some embodiments, one of the cutting surfaces can be removed, such that osteotomy can performed using a single cutting slot, thereby potentially increasing the operator degrees of freedom. In some embodiments, a cutting surface can be removed by disconnecting the two surfaces. In some embodiments, the first surface comprises one or more sliding pins and the second surface comprises one or more grooves shaped and/or sized to accommodate the one or more sliding pins. In some embodiments, upon pulling one surface in parallel to the other, one or more sliding pins slide out of the grooves and disconnect the two surfaces.

In some embodiments, the surgical navigator is comprised of at least two segments, optionally, two segments, each including one of the cutting slots. Removing one of the segments results in a single remaining cutting surface. Removing said segment potentially reveals the bone underneath, thereby potentially further increasing the operator's degrees of freedom. In some embodiments, the removed segment is selected according to an area of the bone that needs to be reviled. In addition, removing a segment of the surgical navigator has the potential advantage of simplifying the removal of a cutting surface. In some embodiments, one or both of the segments comprise one or more grip holes, optionally, shaped and/or sized according to a gripping tool.

An aspect of some embodiments of the invention relates to a surgical navigator having at least one verification component for evaluating the reliability of a produced surgical navigator. In some embodiments, at least one verification component (e.g., a mark on the surgical navigator) is designed to have a specific size and/or shape. A produced surgical navigator having a verification component sized and/or shaped according to the design thereof indicates that the produced surgical navigation is reliable (e.g., shaped and/or sized according to a desired design). In some embodiments, at least one verification component comprises a geometry design to have measurable shape and/or size. For example, the verification component is a coin, designed to have a specific diameter. In some embodiments, the surgical navigator is provided with a designated measurement tool, for example, which comprises a recess shape and/or sized to receive a verification coin. In some embodiments, the surgical navigator comprises more than one verification component, optionally, located distance from each other, optionally, on different portions of the surgical navigator, optionally, next to guiding elements of the surgical navigator. The more than one verification component has the potential advantage of improving the probability of detecting a faulty surgical navigator.

An aspect of some embodiments of the invention relates to a method for designing a surgical navigator for osteotomy on the femur head. In some embodiments, the method comprises identifying the femoral neck-head axis and designing a passageway for a guide implement inline therewith. In some embodiments, this passageway directs the insertion of the guide implement along the femoral neck-head axis, having the potential advantage of minimizing performance errors. In some embodiments, the method comprises identifying the femur neck. In some embodiments, the femur neck is used as reference for defining cutting path through the bone, optionally, parallel to a plane of the femur neck, on the femur head, alternatively, at the femur neck. In some embodiments, the method comprises creating a patient specific body for the surgical navigator, comprising a surface with a geometry which conforms to the bone. In some embodiments, the method comprises designing a surgical navigator customized to a specific set of tools and/or selected surgical approach. In some embodiments, the passageways and/or recesses for operating tools are shaped and/or sized to adjust to selected set of tools and/or surgical approach.

Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

Referring now to the drawings, Figures 1A-C showing perspective views of guiding JIG 100 for a hip resurfacing procedure, in accordance with some exemplary embodiments of the invention. Referring also to figure ID, showing a rear view of guiding JIG 100 for a hip resurfacing procedure, in accordance with some exemplary embodiments of the invention. In some embodiments, guiding JIG 100 comprises a JIG body 102 and guiding elements positioned thereon.

In some embodiments, JIG body 102 comprises a distal end 104 facing the femur neck and a proximal end 106, facing away from the femur neck, towards the femur head.

In some embodiments, JIG body 102 further comprises an inner surface 105 (shown for example in Figure ID) and an outer surface 103. In some embodiments, the inner surface 105 is configured to face the bone (e.g., the femur head), and the outer surface 103 is configured to face the operator. In some embodiments, the geometry of the inner surface 105 complements the geometry of the bone at the treatment site, so that guiding JIG 100 can be positioned steady thereon, optionally, in a single possible configuration. In some embodiments, outer surface 103 comprises at least one mark designed to indicate (e.g., sign and/or point to) familiar anatomical landmarks upon properly placing guiding JIG 100 on the bone. Herein, proper placing of the guiding JIG on the bone is referred, inter alia, to aligning the JIG such that the geometry of its inner surface 105 matches the geometry of the bone. For example, guiding JIG 100 comprises at least one mark on outer surface 103 that points to the greater trochanter and/or lesser trochanter. This at least one mark potentially directs an operator to place the JIG over the bone and/or indicates proper and/or improper positioning.

In some embodiments, JIG body 102 is sized and/or shaped to be deployed on a portion of the target bone (e.g., femur head) at a site intended for treatment.

In some embodiments, guiding JIG body 102 partially circumferentially surrounds the femur head, relative to the femoral neck-head axis (also referred to herein as the center of the femur head axis). In some embodiments, optionally, the geometry of the JIG (surrounding the femur head) provides a natural grip of the JIG on the bone. In some embodiments, this grip has the potential advantage of minimizing the need for invasive fixating onto the bone.

In some embodiments, the contact surface with the bone of JIG body 102 is sufficiently large to enable a steady positioning of JIG 100 on the bone. In some embodiments, This steady positioning is achieved by the match between the geometry of the contact surface and the geometry of the bone surface. In some embodiments, the match optionally enables a single steady positioning. In some embodiments, the JIG body 102 is as small as possible (e.g., minimized) to potentially reduce the extent of required bone exposure, while still enabling steady positioning. In some embodiments, JIG body 102 is designed such that inner surface 105 includes a relatively complex 'topographic' area of the bone for potentially improving and/or facilitating the steady positioning of JIG 100. In addition, JIG 100 designed to include a complex 'topographic' area of the bone potentially enables to decrease the size of JIG body 102 required for achieving said steady positioning, having the potential advantage of further reducing the extent of required bone exposure. For example, in some embodiments, JIG body 102 is designed to cover at least a portion of the femur neck and/or other are showing topographical change, optionally patient- specific areas. In some embodiments, JIG body 102 encompasses and/or at least partially surrounds a portion of the femur head together with a portion of the femur neck, having the potential advantage of improving the match to the bone and/or facilitating achieving a steady positioning. In other embodiments, JIG body 102 encompasses and/or at least partially surrounds a portion of the femur head, potentially reducing and/or avoiding exposure of the femur neck.

In some embodiments, JIG body 102 comprises an aperture 101, for viewing the bone therethrough. In some embodiments, aperture 101 allows the surgeon to evaluate if the guiding JIG has been deployed tightly on the bone, having the potential advantage of additional indication of the alignment of JIG body 102 on the femur head.

In some embodiments of the invention aperture 101, has the potential advantage of easing the deployment of guiding JIG 100 onto the femur head. In some embodiments, aperture 101 further fixes JIG 102 onto the femur head, optionally, by a bone portion protruding from aperture

101, and mechanically obstructing the movement of JIG body 102.

In some embodiments, as mentioned above, guiding elements (e.g., at least one of guiding conduit 112, osteotomy guide 120, and fixating guiding element 218) are positioned on JIG body

102. In some embodiments, the location and/or orientation of the guiding elements define a pathway into the bone for operating tools applied therethrough. In some embodiments, the shape and/or size of the guiding elements corresponds to the shape and/or size of the selected operating tools.

In some embodiments, guiding JIG 100 comprises a guiding conduit 112 for a guide implement (the guide implement is not shown), directing the insertion of the guide implement into the center of the femur head.

In some embodiments, guiding conduit 112 comprises an inner lumen 114, and a wall 116. In some embodiments, inner lumen 114 is shaped according to the shape of a selected guide implement. In some embodiments, inner lumen 114 is sized according to the size of a reducer, optionally shaped as a sleeve (not shown), optionally, a metal sleeve, comprises an inner lumen for inserting the selected guide implement therethrough. In some embodiments, the reducer (e.g., sleeve) defines a cylindrical shape to guiding conduit 112. In some embodiments, the reducer is placed within guiding conduit 112 and reduces the effective diameter thereof. The reducer comprises an inner lumen for inserting a K-wire thereto and into the bone, directed according to the position and/or orientation of guiding conduit 112. After inserting the K-wire into the bone, the reducer can be removed from the proximal opening of guiding conduit 112.

In some embodiments, the size of inner lumen 114 is large enough to accommodate the selected guide implement and/or the selected sleeve, but limited to prevent lateral movement and/or rotation therewithin.

In some embodiments, the location and the orientation of guiding conduit 112 direct the progress of the guide implement into a location and/or a path within the femur head, for example, the center of the femur head, optionally in a single possible path, alternatively, in a range of possible paths. In some embodiments, guiding conduit 112 is in line with the femoral head-neck axis (see below).

In some embodiments, wall 116 comprises a slit 118 (shown in Figures 1C and ID) extending along the longitudinal axis thereof. In some embodiments, this slit has the potential advantage of easing the removal of the guiding JIG while the guide implement (e.g., a sleeve and/or a guide implement such as a Kirschner wire, also referred to herein as K-wire) remains inserted into the femur head. Optionally, a K-wire is passed through slit 118 after removal of a reducer.

In some embodiments, guiding JIG 100 comprises an osteotomy guide 120 including a cutting slot 122, and a support frame 124. In some embodiments, osteotomy guide 120 is configured to direct a cutting implement, cutting the proximal portion of the femur head. In some embodiments, cutting slot 122 is sized and/or shaped to receive a cutting implement, such as a cutting saw, according to the size and/or shape of the first selected implement.

In some embodiments, cutting slot 122 is located and/or oriented to direct a cutting implement to truncate the top of the femur head to fit the inner structure of a selected implant.

In some embodiments, the osteotomy guide 120 directs a cutting tool to truncate the head of the femur, so that the head of the femur will fit steady within the inner structure of the implant. In some embodiments, osteotomy guide 120 directs the progress of a cutting implement cutting the femur head, optionally in a single possible pathway, alternatively or additionally, in a range of possible pathways.

In some embodiments, cutting slot 122 is perpendicular to the femoral neck-head axis. In some embodiments, the location of cutting slot 122 along the femoral neck-head axis defines the size of the removed bone portion. In some embodiments, the location of cutting slot 122 along the femoral neck-head axis is customized and defined by the inner structure of the implant.

In some embodiments, the opening of the cutting slot can be positioned at any location radially to the femoral neck-head axis. In some embodiments, the positioning is customized according to the selected surgical approach (anterior or posterior), in light of the femur head anatomy.

In some embodiments, cutting slot 122 is wide enough to accommodate a selected cutting implement, but sufficiently narrow to limit lateral movement therewithin. For example, the cutting slot is 4mm wide (for example, 3mm, 3.5mm, 4.1mm, 4.5mm), optionally, between about 5 mm and about 3mm. Optionally between about 5.5mm and about 3.5mm, optionally between about 3.5mm and about 3mm. In anoter example, the cutting slot is about 1mm wide (for example, 1mm, 1.5mm, 0.8mm, 1.5mm), optionally, between about 1 mm and about 2mm. Optionally between about 1.5mm and about 5mm, optionally between about 0.5mm and about 2mm. In another example, the cutting slots are 1 mm wide (for example, 0.5mm, 0.7mm, 1.1mm, 1,5mm), optionally, between about 2 mm and about 0.1mm. Optionally between about 1.5mm and about 0.5mm, optionally between about 3mm and about 1mm.

In some embodiments, cutting slot 122 is conically shaped with a wider opening at the entrance of the slot, gradually narrowing towards the bone, having the potential advantage of easing the entrance of the cutting implement.

In some embodiments, optionally, at least one fixating guiding element, such as a guiding conduit for a fixator, is added to guiding JIG 100.

Referring to Figures 2A-C, showing perspective views of guiding JIG 200 for a hip replacement procedure, in accordance with some exemplary embodiments of the invention.

In some embodiments, guiding JIG 200 comprises a JIG body 202 and guiding elements, such as an osteotomy guide 220 positioned thereon.

In some embodiments, JIG body 202 comprises a proximal end 204 facing the femur head and a distal end 206, facing away from the femur head.

In some embodiments, JIG body 202 further comprises an inner surface (not shown) and an outer surface 203. In some embodiments, the inner surface is configured to face the femur neck, and the outer surface is configured to face the operator. In some embodiments, the geometry of the inner surface complements the geometry of the bone at the treatment site, so that guiding JIG 200 can be positioned steady thereon, optionally, in a single possible configuration.

In some embodiments, guiding JIG body 202 partially circumferentially surrounds the femur neck, relative to the femoral neck-head axis. In some embodiments, optionally, the geometry of the JIG (surrounding the femur neck) provides a natural grip of the JIG on the bone. This grip has the potential advantage of minimizing the need for invasive fixating onto the bone.

In some embodiments, JIG body 202 encompasses and/or partially surrounds a portion of the femur neck together with an adjacent portion of the femur head, for potentially increasing the contact surface of JIG 202 and/or for better defining a single steady positioning of JIG 202 on the femur neck. In some embodiments, JIG body 202 is minimized to potentially reduce the extent of bone exposure, optionally, while still sufficiently large to potentially enable said steady positioning.

In some embodiments, guiding JIG 200 comprises an osteotomy guide 220 including at least one cutting slot 222, and a support frame 224. In some embodiments, osteotomy guide 220 is configured to direct a cutting implement, cutting through the femur neck. In some embodiments, osteotomy guide 220 is perpendicular to the femoral neck-head axis, and/or poisoned adjacent to the femur neck.

In some embodiments, the location and/or orientation of cutting slot 222 directs the progress of a cutting implement, cutting the femur neck in a desired pathway, optionally in a single possible pathway, alternatively or additionally, in a range of possible pathways.

In some embodiments, cutting slot 222 is sized and/or shaped to receive a cutting implement, such as a cutting saw, according to the size and/or shape of the first selected implement.

In some embodiments, cutting slot 222 is wide enough to accommodate a selected cutting implement, but sufficiently narrow to limit lateral movement therewithin. For example, the cutting slot is 4mm wide (for example, 3mm, 3.5mm, 4.1mm, 4.5mm), optionally, between about 5 mm and about 3mm. Optionally between about 5.5mm and about 3.5mm, optionally between about 3.5mm and about 3mm. In another example, the cutting slot is about 1mm wide (for example, 1mm, 1.5mm, 0.8mm, 1.5mm), optionally, between about 1 mm and about 2mm. Optionally between about 1.5mm and about 5mm, optionally between about 0.5mm and about 2mm.. In aother example the cutting slots are 1 mm wide (for example, 0.5mm, 0.7mm, 1.1mm, 1,5mm), optionally, between about 2 mm and about 0.1mm. Optionally between about 1.5mm and about 0.5mm, optionally between about 3mm and about 1mm.

In some embodiments, cutting slot 222 is conically shaped with a wider opening at the entrance of the slot, gradually narrowing towards the bone, having the potential advantage of easing the entrance of the cutting implement.

In other embodiments, osteotomy guide 220 comprises a surface (e.g., a cutting surface) configured for directing a cutting tool to cut the bone parallel and adjacent to the plane of the surface., In some embodiments, said surface is shaped and/or sized according to a shape and/or size of a selected cutting tool. For example, said surface may be flat, for directing a straight and/or flat cutting tool, such as a saw. In another example, said surface may be round and/or curved for directing a round and/or curved cutting tool. In another example, said surface may be jagged for directing a jagged cutting tool. In some embodiments of the invention, optionally, guiding JIG 200 further comprises at least one fixating guiding element 218, for directing the insertion of at least one fixator. In some embodiments, the least one fixating guiding element fixes JIG body 202 onto the femur neck, having the potential advantage of reducing the risk for undesired guiding JIG movements during procedure. In some embodiments, at least one fixating guiding element 218 is positioned between cutting slot 222 and proximal end 204. This positioning potentially directs at least one fixator to penetrate a portion of the bone that is intended for removal, having the potential advantage of reducing and/or avoiding injuring the unremoved bone. In some embodiments, at least one fixating guiding element 218 is orientated on JIG body 202 such that a fixator inserted into the bone therethrough will not collide with the osteotomy path.

Alternatively or additionally, at least one fixating guiding element 218 is positioned between cutting slot 222 and proximal end 204. This positioning potentially directs at least one fixator to penetrate a remaining portion of the bone, having the potential advantage of maintaining JIG 202 positioned on the bone and/or improving the JIG stability on the bone during and/or after cutting through cutting slot 222.

In some embodiments of the invention, the guiding JIG (100 and/or 200) is adjusted to be used by a robotic arm.

In some embodiments, the guiding JIG comprises a camera for directing the robotic arm, optionally, the JIG body comprises a designated site for mounting the camera, optionally, shaped and/or sized according to the selected camera.

In some embodiments, the JIG body comprises at least one label, detectable by a camera of the robotic arm. In some embodiments labels on the JIG body direct the progression of the robotic arm. In some embodiments the at least one label is attached to the JIG body after production thereof, alternatively or additionally, the at least one label is inherently printed into the JIG body, optionally, during production thereof.

In some embodiments, the location of the robotic arm is calibrated prior to operation, optionally by determining a desired distance between the robotic arm and the guiding JIG.

In some embodiments, the JIG body comprises a marker, such as a metal screw, for evaluating the alignment of the guiding JIG onto the bone by visualization.

In some embodiments of the invention, the progress of the robotic arm is monitored using a visualization device, such as X-ray device. The robotic arm is updated with a preoperative plane, including the desired path and/or paths into the femur head and/or neck. The robotic arm compares the progress thereof with the preoperative plane and alert for deviations from the desired path and/or paths into the bone. In some embodiments, the guiding elements of the guiding JIG have a conical shape, which widens towards the entrance thereof. This conical shape has the potential advantage of enhancing tolerance for the insertion of operating tools by the robotic arm.

In some embodiments, the guiding elements are elongated, optionally, emerging out of the body. This has the potential advantage of allowing the robotic arm space for movement, external to the body. An additional potential advantage is minimizing the risk of the robotic arm injuring the bone and/or tissues.

Optionally, the elongated guiding elements are supported with sufficient structural support to maintain the stability thereof.

In some embodiments, the guiding elements comprise signs, for the detection thereof by the robotic arm and/or for directing the entrance thereinto. In some embodiments the wall of a guiding element comprises a colored sign, such as a red sign, detectable by a camera of the robotic arm. Alternatively, or additionally, the robotic arm comprises an X-ray device, and the wall of a guiding element comprises a metal sign detectable by X-ray.

In some embodiments, the wall of the guiding elements comprises plurality of marks, for example, parallel lines and/or rings, along the longitudinal axis thereof. The marks are configured to be bent and/or deformed if the guiding elements are bent and/or deformed. This has the potential advantage of indicating if the robotic arm enters into a guiding element improperly.

In some embodiments, the guiding JIG comprises a barcode for updating the robotic arm with the preoperative plane, such as the selected plate type, the selected fixation angle of the plate, the selected set of tools, the selected surgical approach, specific surgical instructions, the location of the guiding elements on the guide body, the distance between the guiding elements, the order of guiding elements to access, which guiding elements to access, depth limitation for insertion, optionally different limitation for each guiding element and/or any combination thereof.

In some embodiments, the barcode refers the robotic arm to external database including the preoperative plane. Optionally, or additionally, the barcode comprises an IFRD element including the preoperative plate.

Referring to Figure 3, showing a concise flowchart describing an exemplary method for designing a guiding JIG, in accordance with some exemplary embodiments of the invention.

At 302, the femoral neck-head axis is identified. In some embodiments, the femoral neckhead axis defines a desired pathway for insertion into the femur head. This pathway has the potential advantage of minimizing deviation from the femoral neck-head axis defined by relatively uniform stress distribution within the femur when the implant is inserted along thereof. In some embodiments, insertion to the femur head through the femoral neck-head axis has the potential advantage of minimizing the risk of bone damage. In some embodiments, the femoral neck-head axis is defined by two points, the center of the femur head and the center of the femur neck.

At 304, a footprint is created. In some embodiments, the footprint is a 3D representation of the femur, simulating the bone geometry of a specific patient. In some embodiments, the creation of the footprint is based on a scan image of the patient, such as a CT scan. This has the potential advantage of requiring measurements of the exposed femoral bone.

In some embodiments, the footprint allows to design a patient specific guiding JIG, having the potential advantage of easing the alignment of the guiding onto the femur head.

At 306, guiding elements are designed. In some embodiments, the guiding elements limit the operation freedom of an operator, optionally, a human surgeon, alternatively or additionally, a robotic arm. In some embodiments, the guiding elements direct operating instruments applied on the femoral bone, therethrough. In some embodiments, the guiding element’s location and/or orientation define a desired pathway into the bone, optionally, a single possible pathway, alternatively or additionally, a range of possible pathways.

At 308, the guiding JIG design is produced, optionally, by 3D printing.

In some embodiments, the 3D printing is based on SLS technology, which uses powder as the source material for printing. Alternatively, or additionally, 3D printing is based on SLA technology, which uses resin as the source material for printing.

In some embodiments, the guiding JIG is printed from biocompatible materials, approved for subcutaneous contact. In some embodiments, the material used is PA12 (Nylon 12 or polyamide 12), optionally, used in SLS technology.

In some embodiments, other biocompatible materials are used, optionally in SLS, technology, alternatively or additionally, in other technologies, such as SLA technology.

In some embodiments, using additional and/or different materials requires adjustment of the thicknesses of the guiding JIG body and/or structural support elements and/or walls of guiding elements thereof, optionally, to obtain a stable guiding JIG structure and/or desired level of flexibility and/or rigidity thereof. For example, if using SLA technology, a relatively thicker JIG body is required.

In some embodiments, the materials are durable for a sterilization process and/or relatively easy to disinfect. In some embodiments, the material(s) are selected according to an input from a surgeon, optionally, input regarding the sterilization process. In some embodiments, the production is fully automated, alternatively or additionally, the production is semi-automated.

In some embodiments, the production is subsequent to the design process. In some embodiments, the guiding JIG produced in a time interval from the design process based on a digitized file of the design.

In some embodiments, the method for designing a guiding JIG is similar and/or as described in Provisional Patent Application No. 63/472,602 filed on June 13, 2023, and/or in the PCT application derived therefrom, having a docket number of 100411, and the contents of which are hereby incorporated by reference.

In some embodiments, said designing a guiding JIG is performed using a user interface (UI) and/or a graphical user interface (GUI) as described in Provisional Patent Application No. 63/472,602 filed on June 13, 2023, and/or in the PCT application derived therefrom, having a docket number of 100411, and the contents of which are hereby incorporated by reference.

In some embodiments, the 3D representation of the JIG is automatically designed without necessarily requiring manual input. The features of the femur and/or foot print and/or guiding elements and/or other parameters described herein may be automatically selected according to a surgical plan defining a surgical indication. A 3D representation of the JIG may be automatically generated to comply with the surgical plan and/or features of the femur and/or foot print and/or guiding elements and/or other parameters described herein. A user may manually adapt the surgical plan and/or features of the femur and/or foot print and/or guiding elements and/or other parameters described herein, which may trigger an automatic adaption of the 3D representation of the JIG, rather than adapting the 3D representation of the JIG directly. For example, the user may adapt the location and/or shape of the footprint for automatically generating the adapted JIG, rather than adapting the JIG to fit the adapted footprint. The JIG may be 3D printed by a 3D printed according to the 3D representation.

Referring to Figures 4A-B are a flowchart describing an exemplary method for the identification of the femoral neck-head axis, in accordance with some exemplary embodiments of the invention.

At 402 a scan image of the patient's femur is received. In some embodiments, a CT scan, alternatively or additionally, an X-ray scan is received.

At 404, a 3D mesh file is created, defining a 3D anatomical model of the femur. In some embodiments, the mesh file represents the anatomy of the patient’s femoral bone, resulting from segmentation of the scan image, defining a representation of the patient’s bone anatomy 900 (shown in figure 9A).

At 406, the mesh file which represents the anatomy of the femur, is deconstructed to naked lines and naked points, as shown in Figure 9A.

At 408, the naked vertices are compiled into a list, optionally including all the naked vertices, alternatively, including the majority of the naked vertices.

At 410, the list of naked vertices is sorted according to Z-values which represent height, with respect to a longitudinal axis of the femur, optionally, in descending order. Alternatively, or additionally, the list of naked vertices is filtered by height, with respect to a longitudinal axis of the femur, to include the highest values.

At 412, the points from the naked vertices list, having the highest Z-value are compiled into a sup list. The sup list represents the proximal portion of the femur head 902, shown in Figure 9B. In some embodiments, the sup list includes about 500 points of the highest Z-values from the naked vertices list.

At 414, a fit sphere 904 (shown in figure 9C), which represents the femur head is created, by using a maximum number of naked points from the sup list, possible to represent the femur head.

At 416, a midpoint 910 at the center of the femur head is identified, as shown in Figure 9F.

At 418, a second sphere 906 (shown in Figure 9D), is created based on fit sphere 904. The second sphere is co-centered with the fit sphere. In some embodiments, the size of the second sphere is expanded relative to the fit sphere, optionally, one and a half times larger than the fit sphere.

In some embodiments, the size of the second sphere can be adjusted to obtain an area where the geometry (boundary) thereof intersects in the femur neck, as shown in Figure 9D. Optionally, by a human user, alternatively or additionally, by machine learning.

At 420, a contour 908, which represents the center of the femur head, is identified. In some embodiments, the contour is at the intersection between the second sphere and the bone geometry, as shown in Figure 9E.

At 422, a midpoint 910 located at the center of the area defined by contour 908, is identified (shown in figure 9F), representing the center of the femur neck.

At 424, the femoral neck-head axis 912 is represented by a line between the center of the fit sphere 914, and the midpoint representing the center of the femur neck 910, as shown in figure 9G. Referring to Figure 5, showing a flowchart describing an exemplary method for the generation of a footprint for hip resurfacing guiding JIG, in accordance with some exemplary embodiments of the invention.

At 502, a representation of an implant is placed 1002 (shown in Figure 10A) onto the femur head. In some embodiments, the size of the implant is determined by the program according to the size of the femur head.

At 504, the representation of the implant is aligned onto the femur head. The longitudinal midline of the implant 1004 (shown in Figure 10A) is aligned with the femoral neck-head axis 910, such that midline 1004 is in line with the femoral neck-head axis 910. The inner geometry of the implant defines the location of a cutting slot (shown in Figure 12E) along the femoral neck-head axis.

At 506, a reference cylindrical geometry is created. The reference cylinder 1006 has a diameter equivalent to the diameter of fit sphere 904, representing the femur head. The proximal base 1008 of cutting plane 1210 (shown in Figure 12E) overlaps with the cutting slot. The distal base is located 1010 at the femur neck.

At 508, a footprint 1012 (shown in Figure 12C) is created. The overlap between an elongated and/or expanded cylinder (not shown) relative to the cylindrical reference geometry, and the femoral bone anatomy defines the footprint.

Referring to Figures 6A-C showing a flowchart describing an exemplary method for the design of guiding elements for hip resurfacing guiding JIG, in accordance with some exemplary embodiments of the invention.

At 602, a cylinder 1202 (shown in figure 12A) is created. In some embodiments, cylinder 1202 represents a guide implement inserted into the center of the femur head and protruding therefrom. In some embodiments cylinder 1202 is in line with the femoral neck-head axis 910. In some embodiments, the size and/or shape of cylinder 1202 represents the size and/or shape of a selected guiding implement. In some embodiments of the invention cylinder 1202 has a diameter of 2.

At 604, a second hollow cylinder 1204 (shown in figure 12B) is created based on cylinder 1202, hollow cylinder 1204 representing the guiding conduit for a guide implement. In some embodiments, hollow cylinder 1204 is concentered with cylinder 1202, having an inner diameter greater than the diameter of cylinder 1202. In some embodiments, the difference between the inner diameter of hollow cylinder 1204 and the diameter of cylinder 1202 is a representation of the tolerance for inserting the selected guide implement into the guiding conduit for guide implement. In some embodiments of the invention, the thickness of the walls of hollow cylinder 1204 represents the thickness of the walls of a guiding conduit for a guide implement. In some embodiments hollow cylinder 1204 is 2 mm thick and/or has an inner diameter of 10 mm.

At 606, a reduced sphere 1206, relative to fit sphere 904 which represents the femur head is created. In some embodiments, reduced sphere 1206 defines an aperture on the JIG body. In some embodiments, the reduced sphere is located at the center of the footprint. In some embodiments, reduced sphere 1206 is about 50% of the size of fit sphere 904, as shown in Figure 12C.

At 608, the reduced sphere 1206 is subtracted from footprint 1012, defining an aperture 1208 on the JIG body, as shown in Figure 12D.

At 610, a cutting plane 1210 is created. In some embodiments, the cutting plane 1210 is perpendicular to the femoral neck-head axis. In some embodiments, cutting plane 1210 is placed along the femoral neck-head axis according to the implant, optionally according to a cutting protocol of the implant.

At 612, cutting plane 1210 (shown in figure 12E) is thickened to create a representation of a cutting slot 1212. In some embodiments, the thickness of the representation of cutting plane 1210 is defined by the size of a selected cutting implement, such as a saw. In some embodiments of the invention, the thickness of the representation of the cutting plane is a combination of the size of a selected cutting instrument and the level of desired tolerance. In some embodiment cutting plane 1210 is thickened to 1.1 mm.

At 614, cutting plane 1210 is further thickened to create a representation of an osteotomy guide frame 1214 (shown in Figure 12F). In some embodiments cutting plane 1210 is thickened proximally and distally, uniformly. In some embodiments, the representation of the osteotomy guide frame is co-centered with the representation of cutting slot 1212. In some embodiments osteotomy guide frame 1214 is 3 mm thick.

At 616, the representation of osteotomy guide frame 1214 is rotated around the femoral neck-head axis, to position the representation of cutting slot 1212, according to a selected surgical approach, as shown in Figure 12F.

At 618, the footprint is thickened to create a representation of the JIG body.

At 620, the representation of the JIG body is combined with hollow cylinder 1204.

At 622, the representation of the JIG body is further combined with the representation of the osteotomy guide frame 1214.

At 624, the representation of cutting slot 1212 is subtracted from the combined model. At 626, the representation of cylinder 1202, representing a guide implement (such as a K- wire) , is further reduced from the combined model.

At 628, the representation of the bone anatomy 900 is further reduced from the combined model to receive a representation of the guiding JIG 1216, shown in Figure 12G.

At 630, optionally, creating a representation of a slit along the walls of hollow cylinder 1204. Optionally by subtracting a portion of the guiding JIG, such that a slit is created along the longitudinal axis of the cylinder.

At 632, optionally, a draft angle for the guiding JIG is designed. In some embodiments, a representation of a volume from the inner structure of the guiding JIG is reduced, optionally, apportion of the JIG body representing the anatomy of the bone. In some embodiments, larger reduced volumes allow larger draft angle. In some embodiments, the draft angle is 5 degrees in the direction opposite to the direction of approach. In some embodiments, the amount of reduced volume is adjusted to correspond to the desired draft angle.

At 634, the guiding JIG is produced, as described in step 308 of Figure 3.

Referring to Figure 7, showing a flowchart describing an exemplary method for the generation of a footprint for hip replacement guiding JIG, in accordance with some exemplary embodiments of the invention.

At 702, a cutting plane 1102 (shown in figure 11 A) is created. In some embodiments, cutting plane 1102 is perpendicular to the femoral neck-head axis 910 (shown in Figure 11A). In some embodiments, the cutting plane can be located at any point between the center of the femur head and the center of the femur neck, along the femoral neck-head axis. In some embodiments, this location is defined by a selected implant and/or by an input from a physician, optionally, based on a desired final leg length and/or additional surgical and/or anatomical reasons. In some embodiments, cutting plane 1102 is positioned at the center of the femur neck. In some embodiments, cutting plane 1102 is positioned at the midpoint the center of the femur head, and the center of the femur neck as shown in figure 11A. At 704, a box reference geometry 1104 is created, over the cutting plane, as shown in figure 11B. In some embodiments, the cross-section surface of box reference geometry 1104 is equivalent to the surface of cutting plane 1102. In some embodiments, box reference geometry 1104 is thickened relatively to the femoral neck-head axis 910, optionally to 20 mm.

At 706 a footprint 1106 is created, in some embodiments, the overlap between box reference 1104 geometry and the femoral bone anatomy defines footprint 1106, as shown in Figure 11C. Referring to Figures 8A-B showing a flowchart describing an exemplary method for the design of guiding elements for hip replacement guiding JIG, in accordance with some exemplary embodiments of the invention.

At 802, a JIG body 1302 is created by thickening footprint 1012 (previously described in Figure 6B). In some embodiments footprint 1012 is thickened radially to the femoral neck-head axis 910, optionally, to 3.5 mm thick.

At 804, cutting plane 1102 (previously described in figure 7), is thickened longitudinally radially to the femoral neck-head axis 910, to create a representation of a cutting slot 1304 (shown in Figure 13C).

In some embodiments, the direction of the opening of representation of a cutting slot 1304 is according to the selected surgical approach.

At 806, the cutting plane 1102 is further is thickened longitudinally radially to the femoral neck-head axis 910, to create a representation of an osteotomy guide 1306 (shown in figures 13B- C). In some embodiments, the representation of an osteotomy guide 1306 is thickened such that osteotomy guide 1306 is co-centered with the representation of cutting slot 1304.

In some embodiments, optionally cutting plane 1102 can be first thickened to create a representation of an osteotomy guide 1306, and then less thickened to create a representation of cutting slot 1304 (as shown in figures 13B-C).

At 808, the representation of JIG body 1302 is combined with the representation of an osteotomy guide 1304.

At 810, the representation of cutting slot 1304 is subtracted from the combined model.

At 812, representation of bone anatomy 900, further subtracted from the combined model.

At 814, optionally, a draft angle for the guiding JIG is designed, as described in step 632, figure 6C.

At 816, the guiding JIG is produced, as described in step 308 of Figure 3.

Referring to Figure 14 showing a flowchart describing a workflow of a surgeon using guiding JIG during a hip resurfacing procedure, in accordance with some exemplary embodiments of the invention.

At 1402, the guiding JIG is mounted on the femur head. The guiding JIG is placed on the femur head and is configured to act as a guide for an operator, optionally, by a human operator, alternatively or additionally by a robotic arm.

In some embodiments, the guiding JIG is further aligned on the femur head. In some embodiments, since the inner surface of the JIG body comprises geometry which complements the geometry of the bone, the guiding JIG can be placed steady thereon in a single possible configuration. This alignment has the potential advantage of minimizing further errors caused by incorrect placement of the guiding JIG. An additional potential advantage is that the alignment can potentially be performed by operators having less or no training.

In some embodiments, the operator is viewing the bone through the aperture of the JIG body, to evaluate if the JIG body is placed sufficiently tight on the bone. This as a potential advantage of further minimizing alignment errors.

In some embodiments, the guiding JIG is designed based on a scan image of the patient’s femur, less requiring and/or not requiring measurements of the exposed bone. This has the potential advantage of minimizing measurement errors which might cause further errors while applying operating tools on the bone. An additional potential advantage is minimizing the period of time in which the patient is cut open and/or reducing the duration of the procedure.

In some embodiments, the insertion of a bulky measurement device is not required, alternatively or additionally, exposure of the entire femur head for measuring the circumferential thereof is not required, having the potential advantage of reducing the required incision size.

In some embodiments the guiding JIG comprises guiding elements for directing operating tools inserted therethrough into the bone, once the JIG body is placed and/or aligned on the bone, the guiding elements are positioned to direct an insertion therethrough in a desired pathway into the bone. A potential advantage of the guiding elements position is that hip resurfacing procedures can potentially be performed by operators having less or no training.

At 1404, a guiding sleeve, optionally, a reducer in the form of a metal sleeve is inserted into the guiding conduit. The guiding conduit has a cylindrical shape according to the shape of the sleeve so that the guiding sleeve is mounted steady within the guiding conduit

At 1405, a guiding implement is inserted through the metal sleeve mounted within the guiding conduit of the guiding JIG. In some embodiments, the insertion of the guide implement through the metal sleeve has the potential advantage of minimizing damage to the guiding JIG during the insertion of the guide implement. In some embodiments, the orientation and/or location of the guiding conduit define a pathway into the bone, having the potential advantage of minimizing performance errors resulting in a deviation from the desired pathway.

In some embodiments, the guiding conduit directs a guide into the center of the femur neck, optionally, in line with the femoral neck-head axis. A potential advantage of this direction is that less visualization and/or no visualization is required. A potential advantage of minimizing visualization is the reduction of exposure to x-ray radiation. In some embodiments the pathway is based on a computed 3D simulation of the patient’s anatomy, having the potential advantage of minimizing errors in evaluations of the pathway into the center of the femur neck.

In some embodiments inserting a guide implement through the guiding conduit of the guiding JIG less and/or not requiring prior insertion of an additional guide, for the guide implement to be loaded thereon, this has the potential advantages of simplifying the procedure and/or reducing the duration of the procedure.

At 1406, osteotomy on the femur head is performed, through a cutting slot of the guiding JIG. The femur head is truncated by a cutting tool, such as a saw, cutting the femur head through the cutting slot, resulting in a bone portion separated from the femur head. The location and/or orientation of the cutting slot is defined by the implant.

In some embodiments, the cut of the bone is performed around the guiding implement, inserted into the bone. Alternatively, or additionally, the osteotomy can be preformed prior to the insertion of the guide implement into the center of the femur head, having the potential advantage of simplifying the cutting.

In some embodiments subsequent to the osteotomy, the sleeve is removed from the inner lumen, optionally by using the slit along the guiding conduit. In some embodiments, subsequently, the guiding JIG is removed from the bone while remining the guiding JIG inserted into the center of the femur head and protruding thereof, optionally, by using the slit along the guiding conduit

In some embodiments, a cylinder cutter is further applied on the femur head to shape thereof to fit to the inner geometry of the implant.

In some embodiments, further preparations are performed on the bone using the guide implement inserted into the femur head, optionally, by applying operating tools loaded on the guide implement.

At 1408, an implant is mounted on the femur head. The implant is selected according to the femur head size, optionally by a program designing the guiding JIG.

In some embodiments, the implant is inserted through a cavity into bone resulting from inserting a guide implement through the guide conduit direct into the center of the femur neck. In some embodiments, the longitudinal midline of the implant is in line with the femoral neck-head axis, having the potential advantage of minimizing the risk for loosening of the implant and/or non- uniform distribution of stresses that might result in fracture of the femur neck.

Referring to figure 15, showing a flowchart describing a workflow of a surgeon using guiding JIG during a hip replacement procedure, in accordance with some exemplary embodiments of the invention. At 1502, the guiding JIG is mounted of the femur neck. The guiding JIG is placed on the femur neck and is configured to act as a guide for an operator, optionally, by a human operator, alternatively or additionally by a robotic arm.

In some embodiments of the inventions, an input from the surgeon is received optionally describing the selected implant, the length of the selected implant defines the location of the cutting slot of the osteotomy guide.

In some embodiments, the guiding JIG comprises an osteotomy guide for directing a cutting tool inserted therethrough into the femur neck, once the JIG body is placed and/or aligned onto the femur neck, the osteotomy guide is positioned to direct insertion therethrough in a desired pathway into the bone. A potential advantage of the guide osteotomy position is that hip replacement procedures can potentially be performed by operators having less or no training.

At 1506, osteotomy on the femur neck is performed, through a cutting slot of the guiding JIG. The femur neck is cut by a cutting tool, such as a saw, cutting the femur neck through the cutting slot, resulting in the removal of the femur head femur head. In some embodiments, the location and/or orientation of the cutting slot along the femur neck is defined by the implant. This has the potential advantage of minimizing over- shortening and/or under- shortening of the femur neck, which might result in incompatibility with the implant and/or undesired leg length.

. In some embodiments, the cutting slot of the guiding JIG defines the geometry of the bone surface coming in touch with the implant. In some embodiments cutting through the cutting slot results in a surface having a geometry which completes the geometry of the surface of the implant that comes in contact with the femur neck. A plurality of osteotomy guide

Referring now to figures 16A-C showing perspective views of guiding JIG 1600 having a plurality (e.g., more than one) of osteotomy guides for a hip resurfacing procedure, in accordance with some exemplary embodiments of the invention.

It should be understood that the feature of a plurality of osteotomy guides is demonstrated on guiding JIG 2600 to allow a person having skills in the art to understand the invention and is not intended to limit the invention in any way. The feature of a plurality of osteotomy guides can be employed on various other guiding JIGs.

Guiding JIG 1600 and guiding JIG 100 are similar to each other in their features. The same reference numerals have been used to denote parts that are similar to those described for guiding JIG 100, with the prefix 16 replacing the prefix 1.

Guiding JIG 1600 shows one or more of the following additional features:

In some embodiments, guiding JIG 1600 comprises a plurality (e.g., more than one osteotomy guide 1620). In some embodiments, plurality of osteotomy guides 1620 potentially defines more than one osteotomy path, for an operator (e.g., a surgeon and/or a robotic arm) to select therefrom, optionally during surgery. Alternatively or additionally, the operator may cut the bone through more than one osteotomy guide. For example, the operator may first cut the bone according to a relatively proximal osteotomy guide; if the removed bone portion is insufficient (e.g., for the bone to fit within a selected implant) the operator can re-position the JIG and cut the bone according to a more distal osteotomy guide. In some embodiments, JIG 1600 comprises at least one fixating guiding element 1618 (e.g., similar to fixating guiding element 218, shown for example in Figure 2B) for inserting a fixator therethrough. In some embodiments, the at least one fixating guiding element 1618 and/or a cavity formed on the bone by inserting a fixator therethrough, may be used to align JIG 1600 on the bone during the repositioning thereof.

In some embodiments, each osteotomy guide of plurality of osteotomy guides 1626 differs by one or more of its axial positions relative to the center of the femur head axis, radial position relative to the center of the femur head axis, and/or the cutting angle relative to a surface perpendicular to the center of the femur head axis.

In some embodiments, plurality of osteotomy guides 1620 are in the form of a plurality of cutting slots 1622, as shown for example in Figures 16-17. In some embodiments, at least one cutting slot of the plurality of cutting slots 1622 comprises a support frame (e.g., support frame 124 shown for example in figure 1C), optionally, a relatively short frame for potentially allowing access to each cutting slot of said plurality of cutting slots 1622. In other embodiments, at least one and/or all of the cutting slots of the plurality of cutting slots 1622 lack a supporting frame, potentially improving access to each cutting slot and/or allowing JIG 1600 to include more cutting slots.

In some embodiments, the location and/or orientation of the plurality of cutting slots 1622 is determined by a surgeon during the JIG design. Alternatively or additionally, the location and/or orientation of plurality of cutting slots 1622 is determined by a design program/system.

In some embodiments, plurality of cutting slots 1622 is in the form of a pair of cutting slots, as shown for example in figures 16A-B.

In some embodiments, guiding JIG 1600 (and/or any other JIG described herein) comprises one or more structural supports 1626 for potentially supporting guiding conduit 1612. It is to be noted that one or more structural supports 1626 may have a particular use of supporting guiding JIG 1600 having more than one cutting slots 1622.

In some embodiments, guiding conduit 1612 comprises a slit 1618 extending from proximal end 1618 of guiding JIG 1600, (defined by the proximal end of conduit 1612), to the distal end of the conduit, at a circumferential location thereon where there is no connection to JIG body 1602. Slit 118 potentially enables inserting a guide implement (e.g., a K-wire and/or a sleeve shaped reducer) therethrough and then removing guiding JIG 1600 while said guide implement remains inserted within the femur head.

In some embodiments, slit 118 is relatively wide, defining an opening in wall 1614 (e.g., a distance between circumferential ends 1613, 1615 of wall 1614), as shown for example in figures 16A-B. This opening potentially enables and/or facilitates the removal of a guiding JIG while a guide implement is inserted through conduit 1612. In some embodiments, slit 1618 is sufficiently narrow for a reducer, optionally shaped as a cylindrical sleeve, to occupy lume 1614 without passing through slit 1618. In some embodiments, slit 1618 is sufficiently wide for allowing a guide implement (such as a K-wire), inserted into the reducer, to pass through slit 1618, after the reducer is removed. In some embodiments, the diameter of inner lumen 1618 is about 12.5 mm for accommodating a reducer (e.g., a sleeve) having a diameter of about 12 mm. For example, 5-12 mm, or 10-15 mm, or 4- 13mm or about 11 mm, or lower or higher or intermediate ranges or diameters. In som embodiments, the arc length of slit 1618 is about 4 mm potentially allowing a K-wire having a diameter of about 3 mm to pass therethrough. For example, 3.5-4.5 mm, or 2.5-5 mm, or 2-6mm or about 3.2 mm, or lower or higher or intermediate arc lengths.

In some embodiments, slit 1618 is relatively thin, allowing wall 1614 to maintain a tubular shape (e.g., allowing the circumferential ends 1613, 1615 of wall 1614 to contact each other) during the insertion of a guide conduit 1612 and to be opened when removing guiding JIG 1600. Alternatively or additionally, slit 1618 is defined by a line on wall 1614, intended to be cut/torn while and/or before removing JIG 1600. In some embodiments, slit 118 and/or a portion thereof comprises a thin layer of material, and/or spaced holes that define said line. In some embodiments, said line is in the form of a straight, alternatively or additionally, the line can have any other shape, such as curved and/or jagged.

In some embodiments, slit 1618 extends parallel to the longitudinal axis of guiding conduit 1612, alternatively or additionally , slit 1618 at least partially surrounds conduit 1612.

Referring now to Figures 17A-B, showing perspective views of guiding JIG 1700 having more than one osteotomy guide for a hip resurfacing procedure, in accordance with some exemplary embodiments of the invention.

Guiding JIG 1700 and guiding JIG 1600 are similar to each other in their features. The same reference numerals have been used to denote parts that are similar to those described for guiding JIG 1600, with the prefix 17 replacing the prefix 16.

Guiding JIG 1700 shows one or more of the following additional features:

In some embodiments, an osteotomy guide is defined by a pair of guiding conduits 1728 (as shown in figures 17A-B). Pairs of guiding conduits 1728 (and/or guide implements inserted therethrough) define a line therebetween. This line defines a mark for cutting the bone such that a cutting tool can be placed and/or aligned thereon. In some embodiments, the distance between the guiding conduits of Pair of guiding conduits 1728 is sized according to a selected cutting tool.

In some embodiments, guide implements introduced to pairs of guiding conduits 1728 can also function as fixators, anchoring JIG 1700 to the bone. Pairs of guiding conduits 1728 have the potential advantage of reducing and/or avoiding further intrusive fixations.

In some embodiments, plurality of osteotomy guides 1720 is in the form of a plurality of pairs of guiding conduits 1728 for directing guide implements. Plurality of pairs of guiding conduits 1728 potentially allows guiding JIG 1700 to comprise a plurality of osteotomy guides (e.g., more than one) while reducing and/or avoiding impairing the structural strength of the JIG.

Each Pair of guiding conduits directs guide implements to penetrate the bone at a desired location along the center of the femur axis (e.i., a distance from the proximal end of the femur head along the axis representing the center of the femur). Then, the JIG is removed while the guide implements remain inserted within the bone, defining said line.. In some embodiments, the osteotomy is performed by setting a desired cutting angle with respect to the center of the femur axis, for example, a cutting angle of 90. In some embodiments, The osteotomy is performed using a designated cutting tool that can set said cutting angle, alternatively or additionally, The osteotomy is performed using an additional JIG which directs the osteotomy angle. In some embodiments guide implements (e.g., elongated guide implements) placed within pairs of guiding conduits 1728 define a plane therebetween. In some embodiments, pairs of guiding conduits 1728 are oriented such that said plane directs a desired orientation of a cutting tool.

In some embodiments, each osteotomy guide of plurality of osteotomy guides 1720 is in the form of guiding conduit 1728, having the potential advantage of allowing JIG 1700 to comprise a relatively high quantity of osteotomy guides 1720. Each guiding conduit 1720 differs from another by the distance thereof from the proximal end of the femur head, along the the center of the femur head axis.

In other embodiments, at least one osteotomy guide is in the form of a cutting slot (e.g., cutting slot 1622) and the rest of the osteotomy guides are in the form of guiding conduits 1728 for directing bone osteotomy. For example, a main desired osteotomy path is defined by a cutting slot at least one alternative path is defined by said guiding conduit.

A guiding JIG deployable in parts

Referring now to figures 18A-C, showing perspective views of guiding JIG 1800 deployable in parts, in accordance with some exemplary embodiments of the invention.

It should be understood that the feature of deployable in parts is demonstrated on guiding JIG 1800 to allow a person having skills in the art to understand the invention and is not intended to limit the invention in any way. The feature of deployable in parts can be employed on various other guiding JIGs, for example, on any of the guiding JIGs described herein.

Guiding JIG 1800 and guiding JIG 200 are similar to each other in their features. The same reference numerals have been used to denote parts that are similar to those described for guiding JIG 100, with the prefix 18 replacing the prefix 1.

In some embodiments, guiding JIG 1800 (e.g., JIG body 1802) is comprised of more than one JIG portion (e.g., JIG parts) allowing thereof to be deployed on a target site in parts. This deployment has a potential advantage of facilitating mounting JIG 1800 on the bone, potentially, while not comprising the match, optionally a singular steady match, between the guiding JIG and the bone at the treatment site. It is to be noted that said deployment in parts may have a particular use in guiding JIGs having relatively large and/or complex JIG body 1802.

In some embodiments, guiding JIG 1800 comprises at least one portion 1830 (e.g., at least one part and/or a segment) configured to be aligned with the bone geometry and at least one additional portion 1832 (e.g., at least one additional part and/or a segment) configured to be aligned with at least one portion 1830. Alternatively or additionally, at least one additional portion 1832 is configured to be aligned with the bone geometry as well.

In some embodiments, at least one portion 1830 comprises an inner surface configured to face the bone (e.g., femur head) having a geometry that complements the geometry of the bone at the treatment site. This complementation allows guiding JIG 1800 to be positioned steady on the bone, optionally, in a single possible configuration. In some embodiments, at least one portion 1830 is selected and/or defined according to the bone surface and/or structure. For example, at least one portion 1830 is configured to be deployed on a bone portion having protrusions and/or depression, potentially simplifying the alignment of at least one portion 1830 over the bone.

In some embodiments, at least one portion 1830 comprises at least one engagement point 1834 for aligning at least one additional portion 1832 thereto, optionally or additionally, at least one engagement point 1834 enables additional portion 1832 to connect to at least one portion 1830. This connection has the potential advantage of reducing and/or avoiding the insertion of fixator(s) for fixing additional portion 1832.

In some embodiments, at least one engagement point 1834 comprises a geometry that interacts with a complementary geometry 1836 of at least one additional portion 1832. The interaction geometrically interferes with relative movements between the geometry of engagement point 1834 and complementary geometry 1836, thereby fixing and/or anchoring at least one additional portion 1832 to at least one portion 1830 and/or to the bone.

For example, at least one engagement point 1834 comprises at least one protrusion shaped and/or sized to fit within at least one recess of complementary geometry 1836. Alternatively or additionally, at least one engagement point 1834 comprises at least one recess shaped and/or sized to accommodate at least one protrusion of complementary geometry 1836.

In some embodiments, at least one additional portion 1832 is configured to partially cover at least one portion 1830. In some embodiments, at least one engagement point 1834 is positioned on an outer surface of portion 1830 configured to be covered by at least one portion 1832 whereas complementary geometry 1836 is positioned on an inner surface of portion 1832 configured to cover at least one portion 1832. Alternatively or additionally, at least one additional portion 1832 is configured to be adjacent to at least one portion 1830, optionally, not covering at least one portion 1830. In such embodiments, at least one engagement point 1834 and complementary geometry 1836 are located at the contact interface between at least one additional portion 1832 and to at least one portion 1830.

In some embodiments, guiding JIG 1800 enables a removal thereof in parts, having the potential advantage of facilitating the JIG removal procedure. A disassemblable guiding JIG

Referring now to figures 19A-B, showing perspective views of a disassemblable guiding JIG 1900 for a hip replacement procedure, in accordance with some exemplary embodiments of the invention.

It should be understood that the feature of being disassemblable is demonstrated on guiding JIG 1900 to allow a person having skills in the art to understand the invention and is not intended to limit the invention in any way. It should be also understood that the feature of a JIG that is deployable in parts can be employed on various other guiding JIGs, for example, on any of the guiding JIGs described herein.

Guiding JIG 1900 and guiding JIG 200 are similar to each other in their features. The same reference numerals have been used to denote parts that are similar to those described for guiding JIG 200, with the prefix 19 replacing the prefix 2.

In some embodiments, guiding JIG 1900 comprises an osteotomy guide 1920 defined by two surfaces 1924, and 1925 (also referred to herein as cutting surfaces) forming a cutting slot 1922 therebetween. A potential advantage of cutting slot 1922 (as well as for cutting slot 212 shown in figures 2A-C) is reducing and/or avoiding undesired lateral movements of a cutting tool introduced thereinto.

In some embodiments, surfaces 1924, 1925 are parallel to each other, defining cutting slot 1922 having a uniform opening. In other embodiments, surfaces 1924, 1925 are positioned to have a space that narrows as it approaches the bone, having the potential advantage of simplifying the introduction of an operating tool.

In some embodiments, guiding JIG 1900 can be disassembled to include an osteotomy guide 1920 defined by a single cutting surface 1924 or 1925. In some embodiments, osteotomy guide 1920 (defined by two surfaces 1924, 1925) potentially enables the removal of one of surfaces 1924, 1925. A single cutting surface has the potential advantage of facilitating the cutting procedure. An additional potential advantage is to increase the operator's (e.g., a surgeon and/or a robotic arm) degrees of freedom (e.g., allow lateral movements of the cutting tool), for example, if necessary during surgery.

In some embodiments, guiding JIG 1900 comprises two portions, 1930 and 1932, such that portion 1930 comprises cutting surface 1924 and portion 1932 comprises cutting surface 1925. In some embodiments, guiding JIG 1900 is configured for disassembling (e.g., removing) cutting surface 1915, so portion 1930 comprises at least one fixating guiding element 1918 (as shown for example in figures 19A-B). this potentially allows the removal of portion 1932 while reducing and/or avoiding the removal of fixator(s) and/or while allowing portion 1930 to remain anchored to the bone. In other embodiments, guiding JIG 1900 is configured for disassembling (e.g., removing) cutting surface 1924, so portion 1932 comprises at least one fixating guiding element 1918.

Referring now to figures 20A-C, showing perspective views of a disassemblable guiding JIG 2000 for a hip replacement procedure, in accordance with some exemplary embodiments of the invention.

Guiding JIG 2000 and guiding JIG 1900 are similar to each other in their features. The same reference numerals have been used to denote parts that are similar to those described for guiding JIG 1900, with the prefix 20 replacing the prefix 19.

In some embodiments, guiding JIG 2000 (and/or any other guiding JIG described herein) comprises one or more grip holes 2040 for holding guiding JIG 2000, optionally using a gripping tool. For example, guiding JIG 2000 may be gripped at one or more grip holes during a positioning, repositioning, alignment, and/or removal of guiding JIG 2000 and/or a portion thereof. Optionally, one or more grip holes 2040 are shaped and/or sized according to a selected gripping tool.

In some embodiments, guiding JIG 2000 comprises a portion 2032 intended for removal before osteotomy and a portion 2030 intended to remain during and/or direct the osteotomy. In some embodiments, portion 2032 comprises one or more grip holes 2040, having a potential advantage or simplifying the removal thereof.

In some embodiments, guiding JIG 2000 including both portion 2030 and portion 2032 comprises a total JIG body 2002 is sufficiently large to potentially enable steady positioning of JIG 2000 on the bone, optionally a single steady possible positioning. In some embodiments, said total JIG body 2002 potentially encompasses a portion of the femur neck together with an adjacent portion of the femur head, for potentially increasing the contact surface of JIG 200 and/or for better defining a single steady positioning of JIG 2000 on the femur neck.

In some embodiments, after positioning, portion 2032 which includes a cutting surface, for example cutting surface 2025, is removed, optionally, by gripping thereof via one or more grip holes 2040. Then, an osteotomy can be performed using a cutting surface, for example, cutting surface 2024. Alternatively or additionally, an osteotomy can be performed without removing a JIG portion, by cutting the bone through cutting slot 2022, defined between cutting surfaces 2024 and 2025.

In some embodiments, guiding JIG 2000 comprises at least one connection point 2042 for connecting between portion 2032 and portion 2030. This connection potentially enables deploying guiding JIG 2000 as a single unit, optionally, having a sufficient contact surface for aligning the JIG body 2002 on the bone surface. In some embodiments, at least one connection point 2042 is defined by a geometry on portion 2032 (e.g., on surface 2025) and a complementary geometry on portion 2030 (e.g., on surface 2024). For example, in some embodiments, portion 2032 comprises one or more protrusions, while portion 2030 comprises one or more recesses shaped and/or sized to accommodate these protrusions, and/or vice versa. In some embodiments, these protrusions are in the form of sliding pins, shaped and/or sized to be moved along channel- shaped recesses with an open end to allow disconnection. In some embodiments, said geometries are located at a center portion of osteotomy guide 2020, as shown for example in the figures. In other embodiments, said geometries are located at one and/or both sides of osteotomy guide 2020, for potentially allowing to cut through cutting slot 2022.

Alternatively or additionally, cutting surfaces 2024, 2025 are produced (e.g., 3D printed) connected at at least one connecting point 2040, optionally, intended to be cut and/or tom, thereby separating portion 2032 from portion 2030. In some embodiments, osteotomy guide 2020 is produced as a frame that can be cut to form separated cutting surfaces 2024, 2025. In some embodiments, at least one connecting point 2040 is marked for directing cutting thereof. In some embodiments, at least one connecting point 2040 comprises spaced holes over JIG body 2002 and/or a thin layer of JIG body 2002 for potentially directing and/or facilitating the cut.

In some embodiments, a guiding JIG for a hip replacement procedure (e.g., guiding JIG 200, 1900, 2000) and/or a guiding JIG for hip resurfacing procedure (e.g., guiding JIG 100, 1600, 1700) is configured for applying an anterior approach (as shown for example for JIGs 200 and/or 1900. In other embodiments, the guiding JIG is configured for applying a posterior approach (as shown for example for JIG 2000).

The anterior approach is referred to herein as accessing the hip joint from the front of the hip (e.g., through an incision made at the front of the hip), whereas the posterior approach is referred to herein as accessing the hip joint from the back of the hip (e.g., through an incision made at the back of the hip).

In other embodiments, a guiding JIG for hip procedures may be configured for various surgical approaches (other than the anterior and/or the posterior approach), for example, approaching the hip joint from the side.

The JIG body (e.g., JIG body 202 and/or 1902) the inner surface thereof, and/or the positions (e.g., location and/or orientation) of the guiding element are designed according to a selected surgical approach. Sturdy guiding elements

Referring now to Figures 21A-C, showing perspective views of a guiding JIG 2100 having a sturdy guiding element, in accordance with some exemplary embodiments of the invention. The term sturdy is referred to herein, inter alia, as being capable of withstanding contact with sharp objects and/or being resistant to scratches and/or cuts upon contact with sharp objects.

Referring also to Figure 2 ID, showing a perspective view of a sturdy surface(s) for a guiding JIG, in accordance with some exemplary embodiments of the invention.

Referring also to Figure 2 IE, showing a sturdy surface(s) before being folded to achieve a three-dimensional form of the sturdy surface(s), in accordance with some exemplary embodiments of the invention.

It should be understood that the feature of a sturdy guiding element (e.g., sturdy osteotomy guide) is demonstrated on guiding JIG 2100 to allow a person having skills in the art to understand the invention and is not intended to limit the invention in any way. The feature of a sturdy guiding JIG can be employed on various other guiding JIGs, for example, on any of the guiding JIGs described herein.

Guiding JIG 2100 and guiding JIG 200 are similar to each other in their features. The same reference numerals have been used to denote parts that are similar to those described for guiding JIG 200, with the prefix 21 replacing the prefix 2.

In some embodiments, guiding JIG 2100 (e.g., and/or any other guiding JIG described herein) comprises one or more guiding elements, resistant to contact with a sharp operating tool and/or sharp bone residues formed during surgery. This resistance has the potential advantage of reducing and/or avoiding damaging the JIG during surgical procedures which might impair the function thereof. An additional potential advantage is reducing and/or avoiding the creation of JIG residues (segments and/or crumbles from the JIG) that may undesirably remain within the patient’s body.

In some embodiments, guiding JIG 2100 comprises a sturdy osteotomy guide 2120.

In some embodiments, the inner lumen of supporting frame 2124 and/or a portion thereof is covered by one or more sturdy surface(s) 2144, defining a sturdy contact surface(s). Said sturdy contact surface(s), potentially having resistance to scratches and cuts when operating tools and/or sharp bone residues contacting thereof. In some embodiments, one or more sturdy surface(s) 2144 are, shaped and/or sized to be mounted within supporting frame 2124, optionally, according to the shape of supporting frame 2124. In other embodiments, osteotomy guide 2120 comprises a cutting surface (e.g., a single cutting surface) (for example cutting surface 1924 and/or 1925) so one or more sturdy surface(s) 2144 are, shaped and/or sized to be mounted on said cutting surface, optionally, shaped as a surface. In some embodiments, one or more sturdy surface(s) 2144 comprises two sturdy surface(s), optionally parallel to each other, as shown for example in Figure 2 ID. Optionally, the two sturdy surface(s) are connected at a connection area and/or line 2149.

In some embodiments, one or more sturdy surface(s) 2144 comprises and/or is made of metal, such as stainless steel and/or titanium alloys.

In some embodiments, a guiding JIG may comprise a sturdy guiding conduit (e.g., guiding conduit 112). In some embodiments, sturdy guiding conduit e comprises a sturdy surface therewithin, optionally, shaped as a tube and or a tube segment. A sturdy guiding conduit may have a particular use upon drilling therethrough and/or upon introducing sharp and/or rough implements, such as screws.

In some embodiments, one or more sturdy surface(s) 2144 are customized (e.g., shaped and/or sized) according to a selected operating tool and/or according to a guiding JIG design. In some embodiments, the guiding JIG is designed (e.g., shaped and/or sized) to fit onto one or more sturdy surface(s) 2144, optionally, customized sturdy surface(s) 2144, alternatively or additionally, a shelf sturdy surface(s) 2144. For example, in some embodiments, supporting frame 2124 is shaped and/or sized to accommodate one or more sturdy surface(s) 2144, such that one or more sturdy surface(s) 2144 are positioned adjacent to the inner walls of supporting frame 2124.

In some embodiments, one or more sturdy surface(s) 2144 comprises at least one anchor for connecting to a guiding element (e.g., support frame 2124 and/or cutting surfaces). In some embodiments, at least one anchor is in the form of at least one folded end 2146 of one or more sturdy surface(s) 2144, optionally two folded ends, shaped and/or sized to grip the edges of the guiding element (e.g., the edges of support frame 2144). Alternatively or additionally, one or more sturdy surface(s) 2144 comprises additional anchor 2148 optionally in the form of a plate and/or an arm which presses the outer surface of the support frame 2144 against the one or more sturdy surface(s) 2144. This press potentially allows sturdy surface(s) 2144 to cling to the inner surface of support frame 2144 and/or grip a wall of the support frame 2144 (and/or a cutting surface) by pressing it between additional anchor 2148 and the support frame 2124.

In some embodiments, one or more sturdy surface(s) 2144 is produced in a flat form, as shown for example in Figure 2 IE. For example, in some embodiments, one or more sturdy surface(s) 2144 is manufactured and/or cut to have a flat foldable form. In some embodiments, the flat form is folded, for example at the center thereof (e.g., at connection area/line 2149) to obtain a desired three-dimensional shape. Verification elements

Referring still to figure 21C, showing, inter alia, a perspective view of guiding JIG having a verification element 2150, in accordance with some exemplary embodiments of the invention.

In some embodiments, a guiding JIG (e.g., each of the guiding JIGs described herein, such as guiding JIG 100 and/or 200) comprises a verification element 2150 for potentially evaluating that a produced JIG is shaped and/or sized according to a desired design (also referred to herein as a proper production of JIG and/or a JIG properly produced).

In some embodiments, verification element 2150 (e.g., a measurable mark) comprises dimensional elements, designed to have a specific size and/or shape. A produced guiding JIG having a verification element that presents deviation from the pre-designed shape and/or size thereof may indicate improper production on the JIG and/or undesired deformation thereof. This deviation can be detected for example by measuring and/or observing the verification element 2150. This detection potentially indicates to that a produced guiding JIG may be defective, having the potential advantage of reducing and/or avoiding the risk of performing surgery and/or any other medical procedures using a defective JIG.

For example, the verification element may be in the form of a round coin designed to have a specific diameter, a ring with a specific outer and inner diameter, a triangle any quadrilateral with defined side lengths, and/or any other shape having defined dimensions.

In some embodiments, the JIG is provided with a dedicated measuring device that comprises a recess, shaped and/or sized according to the pre-designed shape and/or size of the verification element. A verification element of a produced JIG that fits within said recess and complements the shape and/or size thereof potentially indicates proper production of the JIG (e.g., a production achieving a desired design).

Alternatively or additionally, distortion of the shape and/or size of the verification element and/or of a shape printed thereon can be evaluated using image processing of the JIG.

In some embodiments, the guiding JIG comprises more than one verification element, optionally, distance for each other, optionally on different portions of the guiding JIG body. Identification of the proper production of more than one verification element potentially improves the induction reliability of a proper JIG production. In some embodiments, a verification element is positioned on and/or next to each guiding element of the JIG.

In some embodiments, alternatively or additionally to dimensional elements, the verification element comprises resolution elements, optionally in the form of fine details such as small features, thin walls, and intricate patterns. The resolution elements can be visually inspected (by the human eye and/or by image processing) optionally under magnification, to evaluate the production resolution. In some embodiments, the resolution elements are designed to indicate the reliability of relatively fine features such as the details of the JIG’s inner surface, such as inner surface 105 (e.g., that should match the topography of the bone).

Additional exemplary JIGs

Referring now to Figure 22, showing a front view of an exemplary guiding JIG 2200 for plate fixation of distal radius fractures, in accordance with some exemplary embodiments of the invention.

Guiding JIG 2200 comprises features similar to the other guiding JIGs described herein. The same reference numerals have been used to denote parts that are similar to those described for the other guiding JIGS with the prefix 22.

In some embodiments, guiding JIG 2200 differs from the other guiding JIGs described herein, inter alia, by the following features:

In some embodiments, Guiding JIG 2200 comprises a JIG body 2202 sized and/or shaped to be positioned on a patient’s wrist, at a location of a distal radius fracture. In some embodiments, JIG body 2202 comprises an end 2206 facing the wrist joint and an end 2204 facing away from the wrist joint.

JIG body 2202 comprises an inner surface (not shown) similar in the function thereof to inner surface. In some embodiments, the geometry of the inner surface complements the geometry of at least a portion of the patient’s distal radius, so that potentially guiding JIG 2200 can be positioned steady thereon, optionally, in a single possible configuration.

In some embodiments, JIG 2200 comprises one or more guiding apertures for directing the implantation of a plate. In some embodiments, the one or more guiding apertures are located, oriented, and/or spaced according to a structure of a selected plate (e.g., according to the location, orientation, and/or spaces between the plate screws and/or any other fixators). In some embodiments, JIG 2200 is configured to direct a volar locking plate (also called distal volar radial anatomical plates). In some embodiments, the one or more guiding apertures comprise an aperture 2260 optionally an oval aperture, shaped, sized, and/or positioned according to an oval aperture of the plate. Aperture 2260 directs the drilling of the plate’ s locking screws and/or directs the insertion of other implements (such as a k-wire) for creating at least one opening and/or a hole in the bone intended to receive a locking screw of the plate.

In some embodiments, JIG 2200 is mounted on a patient’s wrist, and at least one opening in the bone is formed by penetrating the bone through aperture 2260. Then, JIG 2200 is removed from the bone and a plate is implanted by inserting at least one of the plate’s locking screws through said opening. This opening/bone potentially directs the implantation of the plate and/or determines a desired positioning of the plate thereon.

In some embodiments, the plate can be implanted over JIG 2200, such that aperture 2260 directs the drilling of the plate locking screws. Then, JIG 2200 is removed from underneath the plate, for example by tearing and/or disassembling thereof (for example, by using similar mechanisms as shown for guiding JIG 1800, shown Figures 18A-C), and the plate is fastened on the bone.

Referring now to Figures 23A-B, showing perspective views of a guiding JIG 2300 for osteotomy and resection surgeries (e.g., orthopedic oncology), in accordance with some embodiments of the present invention.

Guiding JIG 2300 comprises features similar to the other guiding JIGs described herein. The same reference numerals have been used to denote parts that are similar to those described for the other guiding JIGS with the prefix 23.

In some embodiments, guiding JIG 2300 differs from the other guiding JIGs described herein, inter alia, by the following features:

It should be understood that guiding JIG 2300 is demonstrating a guiding JIG for osteotomy and resection surgeries (e.g., orthopedic oncology), to allow a person having skills in the art to understand the invention and is not intended to limit the invention in any way.

Guiding JIG 2300 is designed for the excision of a bone portion (for example, from an acetabulum), optionally a bone portion comprising a tumor. In some embodiments, Guiding JIG 2300 comprises a JIG body 2302 sized and/or shaped to be positioned on a patient’s acetabulum, located adjacent to a tumor. In some embodiments, the size and/or shape of the tumor defines the size and/or shape of JIG body 2302.

In some embodiments, JIG body 2302 comprises an inner surface 2305 that faces and/or contacts the acetabulum. Optionally, JIG body 2302 is concave to potentially enable said contact, as shown for example in Figure 23 B.

In some embodiments, the geometry of the inner surface complements the geometry of at least a portion of the patient’s acetabulum, so that potentially guiding JIG 2300 can be positioned steady thereon, optionally, in a single possible configuration. In some embodiments, the location of the tumor determines the surgical approach and/or the bone portion defining JIG body 2302 and/or the geometry of inner surface 2305.

In some embodiments, JIG 2300 comprises an osteotomy guide 2320 comprising a cutting slot 2322 and optionally a support frame 2324, for example as described herein. The location and/or orientation of osteotomy guide 2320 is defined by the location and/or orientation of the tumor. In some embodiments, the length of the osteotomy guide 2320 is defined by the size of the tumor and/or the size of a selected cutting tool (e.g., the size of the cutting tool is selected according to the size of the tumor).

In some embodiments, guiding JIG 2300 comprises at least one guiding conduit 2318 (and/or guiding aperture) for inserting a guide implement and/or a fixator therethrough, such as a K-wire. In some embodiments, JIG body 2302 comprises an end 2304 facing the tumor and an end 2306 facing away from the tumor. At least one guiding conduit 2318 is placed between osteotomy guide 2320 and end 2306, potentially allowing the guiding JIG to be fixed to the bone during and/or after the osteotomy. In some embodiments, at least one guiding conduit 2318 directs guide implement(s) for guiding the deployment of an implant. In some embodiments, the amount (e.g., number) of at least one guiding conduit 2318 and the position thereof over JIG body 2302 is determined according to a selected implant and/or according to the bone anatomy (e.g., which may define a location for implantation). Figure 23A shows for example a guiding JIG comprises three guiding conduits 2318. In some embodiments, the at least one guiding conduit 2318 is positioned according to a structure of a second JIG which directs an implant onto the bone. In some embodiments, after osteotomy, guiding JIG 2300 is removed without removing from the bone the guide implement(s) inserted therethrough. Then the second guiding JIG is loaded over the guide implements and directs an implant onto the acetabulum.

General

As used herein with reference to quantity or value, the term “about” means “within ± 20 % of’.

The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

The term “consisting of’ means “including and limited to”.

The term “consisting essentially of’ means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.

As used herein, the singular forms “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.

Throughout this application, embodiments of this invention may be presented with reference to a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as “from 1 to 6” should be considered to have specifically disclosed subranges such as “from 1 to 3”, “from 1 to 4”, “from 1 to 5”, “from 2 to 4”, “from 2 to 6”, “from 3 to 6”, etc.; as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range/ranging/ranges between” a first indicate number and a second indicate number and “range/ranging/ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numbers therebetween.

Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art.

As used herein the term “method” refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

As used herein, the term “treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements. Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is/are hereby incorporated herein by reference in its/their entirety.

Claims

WHAT IS CLAIMED IS:

1. A guiding JIG for use during hip resurfacing, comprising: a. a JIG body, shaped and sized to be mounted on the femur head; b. a guiding conduit positioned on the JIG body and defining a path into the center of the femur head; and c. at least one osteotomy guide positioned on the JIG body and defining a path for cutting the femur head.

2. The guiding JIG according to claim 1, wherein the guiding conduit is sized and shaped to receive and direct a guide implement.

3. The guiding JIG according to claim 2, wherein the guiding conduit comprises a slit extending along a wall of said conduit, from a proximal end of said wall, facing away from a femur neck, to a distal end of said wall, facing toward a femur neck, and ends at a portion of said wall not connected to the JIG body.

4. The guiding JIG according to claim 1, wherein the guide osteotomy comprises a cutting slot.

5. The guiding JIG according to claim 4, wherein the guide osteotomy comprises a supporting frame.

6. The guiding JIG according to claim 5, wherein said frame comprises at least one sturdy surface, positioned therewithin.

7. The guiding JIG according to claim 1, wherein the JIG body comprises an inner surface having a geometry which complements the geometry of the femur head of the patient, at the treatment site.

8. The guiding JIG according to claim 7, wherein the JIG body at least partially surrounds the femur head.

9. The guiding JIG according to claim 8, wherein the JIG body has a grip on the femoral head.

10. The guiding JIG according to claim 9, wherein the JIG body at least partially covers the femur neck.

11. The guiding JIG according to claim 1, comprising a measurable mark, designed to have a specific size and shape, configured to be measured to indicate that said guiding JIG is produced according to a desired design.

12. A guiding JIG deployable in parts on a bone, comprising: a. a JIG body comprising more than one JIG parts, shaped and sized to be mounted on the bone; and b. at least one guiding element positioned on the JIG body.

13. The guiding JIG according to claim 12, wherein more than one JIG part comprises a first JIG part and a second JIG part, wherein said first JIG part comprises an inner surface having a geometry that complements the geometry of bone at the treatment site, and wherein said second JIG part configured to be aligned with the first JIG part.

14. The guiding JIG according to claim 13, wherein said second JIG part comprises an an inner surface having a geometry that complements the geometry of bone at the treatment site.

15. The guiding JIG according to claim 13, wherein said first JIG part comprises a first geometry that interacts with a second geometry of said second JIG part; wherein said first geometry and said second geometry are complementary to each other.

16. The guiding JIG according to claim 15, wherein said first geometry comprises one or more protrusions and wherein said second geometry comprises one or more recesses shaped and sized to accommodate said one or more protrusions.

17. The guiding JIG according to claim 15, wherein said first geometry comprises one or more recesses and wherein said second geometry comprises one or more protrusions shaped and sized to occupy said one or more protrusions.

18. The guiding JIG according to claim 12, at least one guiding element comprises one or more of: at least one guiding conduit shape and sized to direct a guide implement into the bone and at least one osteotomy guide, sized and shaped to direct a cutting tool into the bone.

19. The guiding JIG according to claim 18, wherein said at least one guiding conduit is positioned on the JIG body, defining a path into the center of the femur head, and wherein said at least one osteotomy guide is positioned on the JIG body defining a path for cutting the femur head or neck.

20. The guiding JIG according to claim 19, wherein the bone is a femur head and the JIG is designed for a hip resurfacing procedure.

21. The guiding JIG according to claim 18, wherein the bone is a femur neck and the JIG is designed for a hip replacement procedure.

22. A guiding JIG having an adjustable osteotomy guide, comprising: a. a JIG body, shaped and sized to be mounted on a bone; and b. at least one osteotomy guide, comprising a first cutting surface and a second cutting surface, defining a cutting slot therebetween, wherein at least one of said first cutting surface or said second cutting surface is removable.

23. The guiding JIG according to claim 22, wherein the JIG body comprises more than one JIG parts, wherein more than one JIG part comprises a first JIG part comprises said first cutting surface and a second JIG part comprises said second cutting surface, wherein one of said first JIG part or said second JIG part is removable.

24. The guiding JIG according to claim 23, wherein said first JIG part is removable and comprises one or more grip holes, wherein said one or more grip holes are shaped and sized to accommodate a gripping tool.

25. The guiding JIG according to claim 24, wherein said second JIG part comprises at least one fixating guide, sized and shaped for directing a fixator therethrough into the bone.

26. The guiding JIG according to claim 22, comprising at least one detachable connection point between said first cutting surface and said second cutting surface.

27. The guiding JIG according to claim 26, wherein said at least one detachable connection point is defined by a sliding pin of said first cutting surface and a groove of said second cutting surface, wherein said groove is sized and shaped to receive the sliding pin and includes an opening that allows the sliding pin to exit therefrom upon movement.

28. A guiding JIG for use during hip resurfacing or hip replacement procedure, comprising: a. a JIG body, shaped and sized to be mounted on the femur head; b. a plurality of osteotomy guides positioned on the JIG body wherein each osteotomy guide of said plurality of osteotomy guides defines a path for cutting the femur head.

29. The guiding JIG according to claim 28, wherein said plurality of osteotomy guides is in the form of a plurality of cutting slots

30. The guiding JIG according to claim 28, wherein said plurality of osteotomy guides are in the form of a plurality of pairs of tubular guiding conduits.

31. The guiding JIG according to claim 28, comprising a guiding conduit positioned on the JIG body and defining a path into the center of the femur head.

32. A method for performing a hip resurfacing procedure on a femur head using a single guiding JIG, wherein said single guiding JIG comprises: a. a JIG body, shaped and sized to be mounted on the femur head; b. a guiding conduit positioned on the JIG body and defining a path into the center of the femur head; and c. an osteotomy guide positioned on the JIG body and defining a path for cutting the femur head; said method comprising: d. mounting the guiding JIG on the femur head; e. inserting a guide implement into the center of the femur head through guiding conduit for a guide implement; f. cutting the femoral bone through a cutting slot, using the selected cutting tool, to create a bone portion separating from the femur head.

33. The method according to claim 32, wherein the JIG body further comprises an inner surface having a geometry which completes the geometry of the femur head; and wherein the method further comprises aligning the guiding JIG on the femur head by fitting the geometry of the inner surface of the JIG with the geometry of the femur head.

34. A method for designing a guiding JIG, comprising: a. creating a patient-specific 3D simulation of the femur head; b. identifying features of the femur head; c. creating a footprint; and d. designing guiding elements.

35. The method according to claim 34, wherein the patient-specific 3D simulation of the femur head is based on a scan image of the femur head.

36. The method according to claim 34, wherein said identifying comprises identifying the femur neck.

37. The method according to claim 36, wherein said identifying comprises identifying the femoral neck-head axis.

38. The method according to claim 37, further comprising thickening the footprint to represent a JIG body.

39. The method according to claim 38, further comprising positioning the guiding elements on the footprint, each defining a path thereinto.

40. The method according to claim 34, wherein said designing comprises designing one or more of: a. a guiding conduit for a guide implement; and b. an osteotomy guide comprises a cutting slot, shaped and sized to receive a cutting tool.

41. The method according to claim 39, wherein said positioning the guiding conduit for a guide implement comprises positioning in-line with the femoral neck-head axis, and protruding from the bone.

42. The method according to claim 39, wherein said positioning comprises positioning a cutting slot perpendicular to the femoral neck-head axis.

43. The method according to claim 42, wherein said positioning comprises locating the cutting slot on the femur head, at a distance from the femur neck.

44. The method according to claim 42, further comprising positioning the cutting slot on the femur neck and/or in proximity to the femur neck.

45. The method according to claim 43, further comprising receiving an input from a physician.

46. The method according to claim 45, wherein the input from the physician comprises a selected implant, which defines the location of a cutting slot along the femoral neck-head axis.

47. The method according to claim 40, further comprises positioning at least one measurable geometry on the JIG.

48. A guiding JIG, for femur head or neck surgery, obtained by a process comprising: a. creating a patient-specific 3D simulation of the femur head; b. identifying features of the femur head in the simulation; c. creating a footprint based on the identified features; and d. designing guiding elements that are integrated into the guiding jig based on the footprint; and e. producing the guiding JIG.

49. The guiding JIG according to claim 48, wherein said identifying comprises identifying the femur neck and the femoral neck-head axis.

50. The guiding JIG according to claim 49, wherein said designing comprises designing one or more of at least one guiding conduit for a guide implement, and at least an osteotomy guide comprises a cutting slot, shaped and sized to receive a cutting tool.