Robotic assisted laser surgery system

Abstract

A system for processing biological tissue, the system comprising: a tool including a laser operable to perform at least one processing action; a positioning member for positioning the tool relative to the biological tissue to perform the at least one processing action; a controller; a storage device storing electronic program instructions for controlling the controller; and an input member; wherein the controller is operable under the control of the electronic program instructions to: receive input via the input member; process the input; and, based on the processing, control the positioning member and the tool to process the biological tissue.

Description

[0001] Related applications

[0002] This application is a divisional application of the invention patent application filed on August 9, 2017, with international application number PCT / AU2017 / 050840, national application number 201780062416.8, and entitled "Robot-Assisted Laser Surgery System". Technical Field

[0003] This invention generally relates to performing laser reshaping processes relative to biological tissues containing bones.

[0004] Although the invention will be described with particular reference to treatments involving one or more actions of a dynamic surgical procedure performed on biological materials including living human tissues, it should be understood that embodiments of the invention may be used with respect to other biological tissues and for treatments including additional and / or alternative actions. Background Technology

[0005] Any discussion of the background art throughout this specification should not be construed as an admission that such background art is prior art, nor should it be construed as an admission that such background art is widely known or forms part of common knowledge in Australia or worldwide.

[0006] Biological tissues can be difficult to process.

[0007] One type of difficult-to-process biological tissue is bone. From a materials processing perspective, hard biological tissues such as bone are disadvantageous materials due to their complex physical properties (based on multi-component (calcium phosphate (ceramic), collagen (organic), and water) and layered structure).

[0008] Osteotomy is the surgical cutting of bone. This technique is routinely used in orthopedic surgery, such as during arthroplasty, where a portion of a joint suffering from arthritis or damage is removed and replaced with one or more components, such as implants / prostheses, designed to replicate the movement of a normal, healthy joint.

[0009] The osteotomy process is one of the important bone reshaping procedures during orthopedic surgery. Successful arthroplasty depends on accurate and precise osteotomy to ensure component alignment and safe fixation to the bone. The accuracy and quality of bone preparation are key factors for long-term implant survival and good clinical outcomes.

[0010] For example, the outcome of a total knee replacement (TKR) surgery depends heavily on the accuracy of a set of resections performed as part of the procedure in matching the internal geometry of the prosthesis implant. Each resection may differ from the ideal cut plane in position, angle, and the flatness of the resulting surface. Inaccuracies in position and angle lead to poorer prosthesis function and potential loosening of the implant. Inaccuracies in the flatness of any surface result in “point loading,” which can damage the bone and affect implant positioning—thus reducing implant durability and the patient’s stated quality of life.

[0011] To elaborate further, current joint surgery techniques lack the accuracy for precise localization and resection. It has been reported that 20% of total knee replacement patients are dissatisfied with their surgical outcomes, and aseptic loosening persists, becoming the leading cause of revisions within 10 years of surgery.

[0012] Orthopedic surgery has come a long way in adapting to and integrating modern tools, such as sensors and computer-aided design (CAD) tools that generate patient-specific joint designs and bone machining (shaping / cutting) parameters. Nevertheless, surgeons currently use traditional mechanical tools such as saws, drills, hammers, ultrasonic cutters, chisels, and grinders to perform osteotomies. These instruments have several drawbacks, including a lack of accuracy and sub-millimeter precision, potential for thermal damage, transmission of vibrations and biomechanical stress to adjacent bone, and the possibility of bone fragmentation.

[0013] Specifically, conventional sawing techniques produce uneven bone surfaces with gaps large enough to affect implant fixation and positioning. Modern surgical instruments incorporate various features (e.g., narrow grooves to guide the saw blade) designed to improve resection accuracy. Nevertheless, achieving precise bone cuts using current instruments in a clinical setting is difficult, with reported varus-valgus cut errors of 4 degrees and fiexion-extension errors of 10 degrees. Clinical studies have demonstrated that successful bone ingrowth into porous cladding necessitates adequate dose-bone juxtaposition to the porous surface and sufficient initial fixation of the implant. Furthermore, the heat generated by mechanical osteotomy due to friction and heavy mechanical loading can lead to tissue necrosis (death). Tissue necrosis adversely affects bone integration within the implant, thereby reducing long-term implant survival.

[0014] Current orthopedic surgeons rely on a combination of mechanical cutting tools with cutting clamps, computer navigation, and patient-fitted cutting blocks. While these tools are currently widely accepted as the gold standard, each has an inherent degree of error. When additional factors such as the surgeon's experience and skill level are considered, the cumulative effect of this error multiplies exponentially.

[0015] In reality, traditional approaches to orthopedic surgery are associated with human and tool properties that often potentially increase the risk of thermal damage (necrosis). This situation, in turn, leaves considerable room for further development of manipulatory tools and techniques. Further development is needed to address the adverse effects of orthopedic surgery, including (but not limited to): 1) severe damage to tissues within and around the repaired / manipulated area, 2) low precision in final dimensional tolerances on the repaired / manipulated bone, 3) relatively slow surgical procedures, 4) postoperative tissue trauma, 5) severe pain, and 6) in some cases, postoperative complications requiring further surgery and associated increased costs, and 7) low precision in final component positioning.

[0016] Cutting saws and bone chisels are traditional tools used for bone cutting during orthopedic surgery. Newer techniques incorporate burrs. As manual operations, they involve human error and require experienced surgeons, making reproducibility difficult to achieve. In addition to these variability issues, other problems associated with their use exist, such as temperature rise due to prolonged physical contact between the cutting / shaping tool and the bone (leading to friction / abrasion between the tool and bone), and the aforementioned heat-driven tissue necrosis caused by the heavy mechanical loading of the bone during conventional mechanical shaping / cutting. Generally, cutting saw blades are much rougher than cutting burrs, causing bone temperatures to rise above 100°C. This temperature increase is due to the large contact area between the bone and the saw teeth. Furthermore, numerous cuts are required to reshape the bone. Although cutting operations using burrs produce moderate temperatures (50-80°C), burr cutting is limited to shallow cuts and is therefore not an ideal replacement for cutting saws.

[0017] To address the issue of elevated temperatures and prevent associated necrosis, numerous remedies have been explored, primarily focusing on (a) changes in tool design, (b) improved operating procedures, and most importantly (c) the use of saline cooling. Of these, (a) and (b) still require careful operating procedures to achieve lower heat generation. In case of (c), while temperature elevation can be controlled, an effective cooling system must be designed. For cutting tools, internally cooled tools have been reported to be superior to external jet / mist cooling in terms of heat control. Finely designed tools and careful temperature and flow rate control are required to achieve low heat generation. Furthermore, due to the physical contact between the mechanical cutting tool and the bone, extremely careful sterilization processes are necessary to avoid any risk of infection. In addition to these issues, traditional bone shaping / cutting also involves post-operative tissue trauma, severe pain, and long healing / recovery times.

[0018] Osteoarthritis (OA) is the leading cause of disability in developed countries. In Australia, it affects 16.5% of the adult population (3.9 million Australians). Total arthroplasty is considered a treatment option for late-stage osteoarthritis. The number of total arthroplasty procedures performed in Australia has doubled in the past decade, with over 80,000 surgeries performed in 2014, costing the Australian health system over AUD 1 billion.

[0019] According to the World Health Organization (WHO), by 2050, 130 million people worldwide will suffer from osteoarthritis (OA), of whom 40 million will be severely disabled due to the disease.

[0020] Notable demographic trends such as a growing, aging, and increasingly employed population, along with rising obesity rates, are expected to be key drivers of the continued growth of osteoarthritis (OA). According to the United Nations, by 2050, people aged 60 and over will comprise more than 20% of the world's population. Of this 20%, a conservative estimate suggests that 15% will have symptomatic OA, and one-third of these individuals will be severely disabled. According to the WHO, in 2014, it was estimated that more than 1.9 billion adults (aged 18 and over) were overweight. Of these, more than 6 billion were obese. According to the American Journal of Epidemiology, obese women are nearly four times more likely to develop knee OA than non-obese women, and obese men are nearly five times more likely to develop knee OA than non-obese men.

[0021] For the most severe cases of osteoarthritis (OA) where patients experience extreme pain, joint reconstruction surgery may be necessary. Joint reconstruction involves removing the bone surrounding the affected joint and inserting one or more artificial implants as a replacement for the affected bone. According to Knowledge Enterprises, the global market for joint replacement products as a whole (including knee, hip, elbow, wrist, finger / toe, and shoulder) was estimated to be close to $14.9 billion in 2013. According to Frost & Sullivan, the global joint implant market was $34.9 billion in 2014, with knee and hip implant systems being the two largest segments.

[0022] It is against this background that the present invention was developed. Summary of the Invention

[0023] One objective of this invention is to overcome or improve at least one or more of the disadvantages of the prior art, or to provide a useful alternative.

[0024] Throughout this specification, unless the context otherwise requires, the word “comprise / comprises / comprising” shall be understood to imply that it includes the stated steps or elements or a group of steps or elements, but does not exclude any other steps or elements or any other group of steps or elements.

[0025] As used herein, any of the terms “comprising,” “which includes,” or “this includes” are open-ended terms, meaning that at least the elements / features following the term are included, but other elements / features are not excluded. Therefore, “comprising” is synonymous with “including” and means “includes.”

[0026] In the claims, the above description of the invention, and the following detailed description, all transitional phrases such as "comprising," "including," "with," "having," "containing," "involving," "holding," and "consisting of" should be understood as open-ended, meaning "including but not limited to." Only the transitional phrases "consisting of" and "substantially consisting of" should be closed or semi-closed transitional phrases, respectively.

[0027] The term "real-time," such as "displaying real-time data," refers to displaying data without intentional delay, given the processing limitations of a given system and the time required to accurately measure the data.

[0028] While any methods and materials similar to or equivalent to those described herein may be used to practice or test the invention, preferred methods and materials are described. It should be understood that the methods, apparatus, and systems described herein can be implemented in a variety of ways and for a variety of purposes. The specific embodiments described herein are by way of example only.

[0029] The various methods or processes outlined in this article can be decoded into software executable on one or more processors employing any of a variety of operating systems or platforms. Furthermore, such software can be written using any of a variety of suitable programming languages ​​and / or programming or scripting tools, and can also be assembled into executable machine language code or intermediate code that executes on a framework or virtual machine.

[0030] In this regard, various inventive concepts can be embodied in a computer-readable storage medium (or multiple computer-readable storage media) encoded with one or more programs (e.g., a computer memory, one or more floppy disks, compressed optical disks, optical disks, magnetic tapes, flash memory, field-programmable gate arrays or other semiconductor devices, or other non-transitory media or tangible computer storage media), which, when executed on one or more computers or other processors, perform methods for implementing the various embodiments of the invention discussed above. The computer-readable medium may also be transportable, such that the programs stored thereon can be loaded onto one or more different computers or other processors to implement the various aspects of the invention discussed above.

[0031] Throughout this document, the terms "program" or "software" are used in a general sense to refer to any type of computer code or set of computer-executable instructions that can be used to program a computer or other processor to implement various aspects of the embodiments discussed above. Furthermore, it should be understood that, according to one aspect, one or more computer programs that perform the methods of the invention when implemented do not necessarily reside on a single computer or processor, but can be distributed in a modular manner across a variety of different computers or processors to implement various aspects of the invention.

[0032] Computer-executable instructions can take many forms, such as program modules that are executed by one or more computers or other devices. Typically, a program module contains routines, programs, objects, components, data structures, etc., that perform a specific task or implement a specific abstract data type. In various embodiments, the functionality of program modules can typically be combined or distributed as needed.

[0033] Furthermore, data structures can be stored in any suitable form on a computer-readable medium. For simplicity, a data structure can be shown as having fields related by their location within the data structure. Such relationships can also be implemented by assigning storage to fields that have locations in a computer-readable medium that convey the relationships between the fields. However, any suitable mechanism can be used to establish relationships between information in the fields of a data structure, including the use of pointers, labels, or other mechanisms for establishing relationships between data elements.

[0034] Furthermore, various inventive concepts may be embodied in one or more methods, examples of which have been provided. Actions performed as part of a method may be ordered in any suitable manner. Therefore, embodiments in which actions are performed in an order different from that described can be constructed, which may include the simultaneous execution of some actions, even those shown as sequential in the illustrative embodiments.

[0035] As used herein in the specification and in the claims, the phrase “and / or” should be understood to mean “any one or both” of the elements so combined, that is, the elements are combined in some cases and separate in others. Multiple elements listed with “and / or” should be interpreted in the same way, that is, “one or more” of the elements are so combined. Other elements may optionally be present, whether related to or unrelated to those specifically identified by the “and / or” clause. Thus, as a non-limiting example, when used in conjunction with open-ended language such as “comprising,” a reference to “A and / or B” may refer to only A (optionally including elements other than B) in one embodiment, only B (optionally including elements other than A) in another embodiment, both A and B (optionally including other elements) in yet another embodiment, and so on.

[0036] As used herein in the specification and claims, “or” should be understood to have the same meaning as “and / or” as defined above. For example, when separating items in a list, “or” or “and / or” will be interpreted as inclusive, that is, including several elements or at least one of the elements in the list, and including several elements or more than one of the elements in the list, and optionally including additional elements not listed. Only terms that explicitly indicate the opposite, such as “only one of…” or “exactly one of…” or “consisting of…” when used in the claims, will refer to including several elements or exactly one of the elements in the list. In general, when the term “or” as used herein is preceded by an exclusive term such as “any,” “one of…,” “only one of…,” or “exactly one of…,” it should be interpreted only to indicate an exclusive alternative (i.e., “one or the other but not both”). “Substantially consisting of…” when used in the claims should have its ordinary meaning as used in the field of patent law.

[0037] As used herein in the specification and claims, the phrase “at least one” in relation to a list of one or more elements should be understood to mean at least one element selected from any one or more elements in the element list, but does not necessarily include at least one of every element specifically listed in the element list, and does not exclude any combination of elements in the element list. This definition also allows for the optional presence of elements other than those specifically identified by the phrase “at least one” in the element list, whether or not they are related to those specifically identified elements. Thus, as a non-limiting example, “at least one of A and B” (or equivalently, “at least one of A or B”, or equivalently, “at least one of A and / or B”) in one embodiment may refer to at least one (optionally including more than one) A, with no B (and optionally including elements other than B); in another embodiment may refer to at least one (optionally including more than one) B, with no A (and optionally including elements other than A); in yet another embodiment may refer to at least one (optionally including more than one) A and at least one (optionally including more than one) B (and optionally including other elements); and so on.

[0038] For the purposes of this specification, when method steps are described in sequence, the sequence does not necessarily mean that the steps will be performed in chronological order in the sequence, unless there is no other logical way to interpret the sequence.

[0039] Furthermore, where features or aspects of the invention are described in the manner of the Markush group, those skilled in the art will recognize that the invention is therefore also described in the form of any individual member or subgroup of the Markush group.

[0040] The embodiments of the present invention are intended to overcome or at least improve one or more of the deficiencies of the prior art mentioned above, or to provide consumers with a useful or commercially available option.

[0041] Other advantages of embodiments of the invention will become apparent from the following description taken in conjunction with the accompanying drawings, in which preferred embodiments of the invention are disclosed by way of illustration and example.

[0042] According to a first aspect of the invention, a robot-assisted laser osteotomy system is provided for laser reshaping of biological tissue containing bone. The system may include a tool comprising a laser operable to perform at least one processing action. The system may further include a positioning member for positioning the tool relative to the biological tissue to perform the at least one processing action. The system may further include a controller. The system may further include a storage device storing electronic program instructions for controlling the controller. The system may further include an input member. The controller is operable under the control of the electronic program instructions to receive input via the input member. The controller may be further operable to process the input. Based on the processing, the controller may be further operable to control the positioning member and the tool to process the biological tissue.

[0043] According to a specific arrangement of the first aspect, a robot-assisted laser osteotomy system is provided for laser reshaping of biological tissues containing bone, the system comprising:

[0044] The tool includes a laser operable to perform at least one processing action;

[0045] A positioning component for positioning the tool relative to the biological tissue to perform the at least one treatment action;

[0046] Controller;

[0047] A storage device storing electronic program instructions for controlling the controller; and

[0048] Input components;

[0049] The controller can operate under the control of the electronic program instructions to:

[0050] Input is received via the input component;

[0051] The input is processed, and based on the processing, the positioning component and the tool are controlled to process the biological tissue.

[0052] Embodiments and implementations of the aspects described above and those described below may incorporate one or more of the following optional features.

[0053] The processing of the input performed by the controller may include analysis of the input and decision-making based on the analysis. Once a decision has been made, the controller can operate under the control of the electronic program instructions to control the positioning element and the tool to process the biological tissue based on the decision-initiated action.

[0054] In one embodiment, as at least part of the analysis, the controller may operate under the control of the electronic program instructions to: generate one or more criteria related to the at least one processing action based on input, or receive one or more criteria related to the at least one processing action as input; and use the criteria to make the decision.

[0055] In another embodiment, the criteria include at least one of the following: the speed of the at least one processing action; the accuracy of the at least one processing action; the safety of the at least one processing action; and the cleanliness of the at least one processing action.

[0056] As at least part of the analysis, the controller may operate under the control of the electronic program instructions to generate a representation of the biological tissue based on input or to receive a representation of the biological tissue as input. The controller may be further operable to generate another representation of the biological tissue based on input or to receive another representation of the biological tissue as input, wherein the other representation of the biological tissue is a different representation of the biological tissue. The controller may be further operable to make an evaluation based on the representation of the biological tissue and the other representation of the biological tissue, and to use the evaluation to make the decision.

[0057] The representation of the biological tissue may include a representation of the state of the biological tissue. The state of the biological tissue may correspond to the planned state of the biological tissue after the at least one processing action has been performed on the biological tissue.

[0058] The other representation of the biological tissue may include a representation of another state of the biological tissue. This other state of the biological tissue may correspond to the actual state of the biological tissue after the at least one treatment action has been performed on it.

[0059] Making the assessment may include comparing the actual state of the biological tissue after the at least one treatment action has been performed on the biological tissue with the planned state of the biological tissue.

[0060] The input component may include at least one sensor, which may be part of a sensor system or sensor group. Individual sensors within the sensor group are operable to monitor, sense, and collect or measure sensor data and / or information associated with or related to one or more characteristics, properties, and / or parameters of the system, the biological tissue and its surrounding environment, or components, systems, or devices associated with or connected thereto.

[0061] The sensors in the sensor group may include those based on: Raman spectroscopy; hyperspectral imaging; optical imaging; thermal imaging; fluorescence spectroscopy; microscopy; acoustic, 3D measurement, optical coherence tomography, laser power, and any non-invasive sensing.

[0062] The operations performed by the system can occur semi-automatically under the control of a surgeon, or automatically without human intervention.

[0063] The at least one treatment action may be a surgical procedure, and preferably a part of an orthopedic surgical procedure.

[0064] The tool may include a laser operable to perform ablation as one of the at least one processing actions.

[0065] In one embodiment, the processing of the input includes optimizing the operation of the laser to increase the ablation rate based on the interaction dynamics between the radiation beam generated by the laser and the biological tissue.

[0066] In another embodiment, optimization includes attempting to increase or maximize the volume of the eroded biological tissue, taking into account criteria that include at least one of safety and accuracy.

[0067] In another embodiment, the radiation beam is generated by the laser in the form of pulses, and the laser pulses are batched for the ablation process, which includes a set of pre-calculated pulses spanning different locations across the biological tissue.

[0068] In one embodiment, the control includes operating the laser at lower power after the ablation has been performed on the biological tissue to reduce or mitigate damage to the final surface of the biological tissue.

[0069] In another embodiment, the system includes a cooling component for cooling one or more components of the system.

[0070] In another embodiment, the cooling component includes a coolant freezer for freezing the coolant used to cool the laser.

[0071] In one embodiment, the optimized operation of the laser includes an ejector for spraying liquid onto the biological tissue to assist laser ablation and at least partially protect the biological tissue from thermal damage.

[0072] In another embodiment, the ejector liquid comprises water or a water-derived solution (e.g., physiological saline) and is preferably sterilized before use. In an alternative embodiment, the ejector liquid comprises a biocompatible (i.e., non-toxic and inert) solution suitable for acting as a coolant for the biological tissue and capable of absorbing laser radiation to assist the ablation process.

[0073] In another embodiment, the cooling component includes a bundle of at least two segmented insulated conduits.

[0074] In one embodiment, the system includes a shield for providing protection during the treatment of the biological tissue.

[0075] In another embodiment, the shielding element includes a consumable shielding element.

[0076] In another embodiment, the consumable shield includes a particle collector and / or a series of filters and / or traps for filtering and storing particulate matter.

[0077] In one embodiment, the positioning component includes a robotic arm.

[0078] In another embodiment, the processing portion of the tool is provided on the end effector of the robotic arm.

[0079] In another embodiment, the system includes a fine motion component for guiding the processing portion of the tool with increased accuracy.

[0080] In one embodiment, when the input includes input from a 3D measurement sensor, the processing includes using the input to map the geometry of the biological tissue and its surrounding environment.

[0081] In another embodiment, the processing further includes reducing the dimensions of a three-dimensional (3D) geometry to a set or series of two-dimensional (2D) maps based on a plane, sphere, cylinder, or any other coordinate system used for transformation between 3D and 2D.

[0082] In another embodiment, the processing further includes overlaying other sensor information onto the same 2D map.

[0083] In one embodiment, when the input includes input from a hyperspectral sensor, Raman spectroscopy sensor, microscopic sensor, optical imaging sensor, or optical coherence tomography, the processing includes using the input to distinguish the components of biological tissue from those of potential ground materials.

[0084] In another embodiment, when the input includes input from a thermal sensor, the processing includes using the input to determine any temperature effects (e.g., thermal damage) on the treated biological tissue, as well as any further effects that are likely to occur with further processing.

[0085] In another embodiment, when the input includes input from an acoustic sensor, the process includes using the acoustic sensor input to detect whether the tool has treated a non-determined or unintended biological tissue or material.

[0086] In another embodiment, when the input includes input from a laser power sensor, the process includes using the input to determine the actual power being generated by the laser beam.

[0087] In another embodiment, the system includes a reference marker provided by the laser on the biological tissue for tracking the biological tissue.

[0088] In one embodiment, when the input includes input from at least one sensor, the process includes using the sensor input to improve control of the positioning member and the tool to process the biological tissue.

[0089] In another embodiment, the controller includes an intelligent controller for providing intelligent control of the system.

[0090] In another embodiment, the intelligent controller includes a master system coordinator for controlling the operation of the system, including one or more simulation, testing, and data entry operations.

[0091] In another embodiment, the intelligent controller includes artificial intelligence (AI) software that incorporates (but is not limited to) machine perception or machine learning.

[0092] In another embodiment, the system further includes a dynamic focusing optics and a dynamic focusing optics controller; the dynamic focusing optics is operable to dynamically change its focal length via the dynamic focusing optics controller and focus the beam diameter of the laser beam at a target distance determined as desired by the controller.

[0093] According to a second aspect of the invention, a method for processing biological tissue is provided. The method may include the step of storing electronic program instructions for controlling a controller. The method may include another step of controlling the controller via the electronic program instructions to receive input via an input member. The method may include another step: controlling the controller via the electronic program instructions to process the input, and based on the processing, controlling a tool operable to perform at least one processing action and a positioning member for positioning the tool relative to the biological tissue to perform the at least one processing action, thereby processing the biological tissue.

[0094] According to a specific arrangement of the second aspect, a method for processing biological tissue is provided, the method comprising:

[0095] Storing electronic program instructions for controlling the controller; and

[0096] The controller is controlled via the electronic program instructions to:

[0097] Receive input via input component; and

[0098] The input is processed, and based on the processing, a tool operable to perform at least one processing action and a positioning member for positioning the tool relative to the biological tissue to perform the at least one processing action are controlled, thereby processing the biological tissue.

[0099] According to a third aspect of the invention, a computer-readable storage medium is provided that stores instructions thereon, which, when executed by a computing component, cause the computing component to perform a method according to the second generalized aspect as described above.

[0100] According to a fourth aspect of the invention, a computing component is provided, which is programmed to implement the method according to the second generalized aspect as described above.

[0101] According to a fifth aspect of the invention, a data signal is provided that includes at least one instruction capable of being received and interpreted by a computing system, wherein the instruction implements the method according to the second generalized aspect described above.

[0102] According to a sixth aspect of the present invention, a computer program product having a computer-readable medium is provided, the computer-readable medium having a computer program recorded thereon for processing biological tissue, the computer-readable medium including instructions for controlling a controller, the computer program product comprising: a computer program code component for controlling the controller via electronic program instructions; a computer program code component for receiving input via an input component; and a computer program code component for processing the input, and based on the processing, controlling a tool operable to perform at least one processing action and a positioning component for positioning the tool relative to a material to perform the at least one processing action, thereby processing the biological tissue.

[0103] According to a seventh aspect of the present invention, a computer program for processing biological tissue is provided, the program comprising: code for retrieving instructions for controlling a controller, the instructions being stored in a computer-readable medium; code for controlling the controller via electronic program instructions; and code for receiving input via an input member; and code for processing the input and being operable, based on the processing control, to perform at least one processing action, and a positioning member for positioning the tool relative to a material to perform the at least one processing action thereby processing the biological tissue.

[0104] According to an eighth aspect of the present invention, an electronic device is provided, the electronic device comprising: an input component configured to receive input from a user; an output component configured to provide output to the user; a processor coupled to the input component and the output component; and a computer-readable storage medium containing program instructions that, when executed by the processor, cause the processor to: retrieve instructions for controlling a controller, the instructions being stored in the computer-readable medium to control the controller via electronic program instructions to: receive input via the input component; and process the input, and based on the processing, control a tool operable to perform at least one processing action and a positioning member for positioning the tool relative to a material to perform the at least one processing action, thereby processing the biological tissue. Attached Figure Description

[0105] Although any other form may fall within the scope of this invention, one or more preferred embodiments of the invention will now be described by way of example only with reference to the accompanying drawings, in which:

[0106] Figure 1 A high-level physical system architecture is described for embodiments of systems according to various aspects of the present invention;

[0107] Figure 2A Depicting Figure 1 A specific embodiment of the end effector of the system;

[0108] Figure 2B Depicting the reshaping of a patient's bone tissue during surgical procedures. Figure 1 The system's end effector instance uses the configuration;

[0109] Figure 3 , 4 And 5 depict Figure 1 Alternative embodiments of the end effector of the system;

[0110] Figure 6 Described to Figure 1 An alternative embodiment of laser emission from the end effector of the system;

[0111] Figure 7 Depicting Figure 1 Examples of sensors and sensor controllers for the end effector of a system;

[0112] Figure 8 Depicting the removal of bone from implants used in total knee replacement surgery;

[0113] Figure 9 Depicting Figure 1 The location and internal structure of the system's consumable shielding / particle collector;

[0114] Figure 10 Depicting Figure 1 The basic unit of a system;

[0115] Figure 11 A graphical representation depicting the risk of erosion processes in both target and non-target "collateral" organizations;

[0116] Figure 12A and 12B Depicting Figure 1 The laser beam ablation size and pattern of the system;

[0117] Figure 13 Depicting Figure 1 The architecture of the system's controller;

[0118] Figure 14 Depicting Figure 1 A flowchart of the actions taken during the system's watchdog (hardware fault protection) procedure;

[0119] Figure 15 Depicting by Figure 13 A flowchart of the actions performed by the system coordinator of the controller;

[0120] Figure 16 Depicted in Figure 13 A flowchart of the actions performed during the mapping operation of the controller;

[0121] Figure 17 Depicted in Figure 13 A flowchart of the actions performed during the controller's planned operation;

[0122] Figure 18 Depicted in Figure 17 A flowchart of the actions performed during the landmark alignment operation in the planning process;

[0123] Figure 19 Depicted in Figure 17 A flowchart of the actions performed during the material positioning operation in the planning operation;

[0124] Figure 20 Depicted in Figure 17 A flowchart of the actions performed during the standby positioning operation of the planning operation;

[0125] Figure 21 Depicting and utilizing Figure 17 The flowchart of the coordinated and aligned operation of the planning operation for the removal of a set of prosthetic components;

[0126] Figure 22 Depicted in Figure 21 A flowchart of the actions performed during the planned resection operation;

[0127] Figure 23 Depicted in Figure 22 A flowchart of the actions performed during the 3D-to-2D projection of the excision surface in the excision operation;

[0128] Figure 24 Depicted in Figure 22 A flowchart of the actions performed during the 2D to 3D projection of the excision surface in the excision operation;

[0129] Figure 25 Depicted in Figure 1 The controller's surface removal analysis operation and Figure 22 A flowchart of the actions performed during the operation;

[0130] Figure 26 Depicted in Figure 21 A flowchart of the actions performed during the fitting and alignment analysis of the prosthesis components in the prosthesis removal procedure;

[0131] Figure 27 Depicted in Figure 13 A flowchart of the actions performed by the controller during bioanalysis operations;

[0132] Figure 28 Depicted in Figure 13 A flowchart of the actions performed by the controller during acoustic analysis operation;

[0133] Figure 29 Depicted in Figure 13 A flowchart of the actions performed by the controller during laser optimization operation; and

[0134] Figure 30 A computing device is depicted above which various embodiments described herein may be implemented according to an embodiment of the present invention. Detailed Implementation

[0135] The scope of this invention is not limited to the specific embodiments described below. This detailed description is intended for illustrative purposes only. Functionally equivalent products, components, and methods are within the scope of the invention as described herein. In this regard, those skilled in the art will understand that the invention described herein allows for variations and modifications other than the specific descriptions, and it should be understood that the invention encompasses all such variations and modifications. The invention also includes all steps, features, components, and compounds individually or collectively mentioned or indicated in this specification, as well as any one and all combinations or any two or more of said steps or features.

[0136] Further features of the invention are described more fully in the examples herein. However, it should be understood that this detailed description is contained for illustrative purposes only and should not be construed in any way as limiting the broad description of the invention as set forth above.

[0137] The complete disclosure of all publications listed herein (including patents, patent applications, journal articles, laboratory manuals, books, or other documents) is hereby incorporated by reference. It is not acknowledged that any of the references constitutes prior art or part of common general knowledge to those skilled in the art to which this invention pertains.

[0138] Throughout this specification, unless otherwise specified herein, the words “comprise” or variations such as “comprises” or “comprising” should be understood to imply inclusion of the stated whole or group of wholes, but not to exclude any other whole or group of wholes.

[0139] Furthermore, throughout this specification, unless otherwise specified herein, the word “include” or variations such as “includes” or “including” should be understood to imply inclusion of the stated whole or group of wholes, but not to exclude any other whole or group of wholes.

[0140] Other definitions of the selected terms used herein are to be considered applicable within and throughout the specific embodiments of the invention. Unless otherwise defined, all other scientific and technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0141] The invention described herein may encompass one or more value ranges (e.g., magnitude, displacement, and field strength). A value range will be understood to include all values ​​within the range, including the value defining the range, and values ​​adjacent to the range that result in the same or substantially the same result as the value immediately adjacent to the boundary of the defining range. For example, those skilled in the art will understand that a 10% variation in the upper or lower limit of the range is perfectly appropriate and covered by this invention. More precisely, the variation in the upper or lower limit of the range will be 5%, or as is generally understood in the art, whichever is larger.

[0142] Throughout this specification, relative language such as “approximately” and “about” is used. This language attempts to incorporate at least 10% variability relative to a specified number or range. This variability can be positive or negative 10% of the specified particular number.

[0143] In the diagram, similar features have been referenced using labels similar to those in the attached diagram.

[0144] As is evident from the background art discussion herein, traditional cutting / shaping techniques, despite their drawbacks, remain in use. Embodiments of the present invention attempt to improve this situation by eliminating (a) complex system arrangements, (b) variability introduced by human factors, and (c) the physical contact between the cutting / shaping tools and the bone.

[0145] To this end, the implementation scheme employs different methods to attempt an optimal shaping / cutting operation. This is based on using a high-intensity laser beam with an extremely short duration, non-physical contact as the energy source for shaping / cutting. The pulse width (or pulse duration) of the laser pulse from laser module 130 can be in the range of approximately 0.1 to 1000 μs. The average output power of the laser from laser module 130 can be in the range of approximately 0.1 to 2000 W. This high-intensity focused laser beam can advantageously remove bone material in an extremely short duration without causing any or at least reducing thermal necrosis and mechanical damage to the material surrounding the bone-laser interaction region 63. The laser beam 30 is focused onto a point on the biomaterial 12, with a spot size typically between approximately 300 and 1000 μm in diameter to deliver laser energy to the biomaterial 12 at a concentration of approximately 0.1 to 1000 J / cm². 2 Laser energy for material ablation within a range of energy density (flux), typically between approximately 10 and 150 J / cm² under normal operating conditions. 2 Within the range between [specific ranges]. Furthermore, as will be described in more detail, the disclosed laser-based bone reshaping / cutting techniques are highly suitable for automation and reductions in human intervention and operation time, while increasing the precision of the reshaping / cutting. In addition, these inherent advantages can generate secondary benefits such as rapid patient recovery and cost reduction.

[0146] Any type of laser suitable for bone shaping / cutting operations can be used, such as gas lasers, like CO2 lasers (with emission wavelengths between about 9 μm and about 12 μm); or solid-state lasers, including ErYAG lasers (wavelength: 2940 nm), Nd:YAG lasers (wavelength: 1064 nm), Tm:YAG lasers (wavelength: 2000 nm), Hg:YAG lasers (wavelength: 2100 nm), or other suitable laser systems as a skilled reader will understand, preferably having an emission wavelength compatible with the absorption of water abundantly present in biological tissues, and which can also be applied to the interaction site to increase the efficiency of the ablation process via the interaction between laser radiation 30 and the water-based solution. Water has a significant absorption coefficient of about 3 μm, so laser sources capable of laser emission near this absorption peak (e.g., Er:YAG lasers, which emit at 2940 nm) are particularly suitable for laser ablation processes in biological material 12. It should be understood that the proposed laser-based shaping method is well-suited for semi-automation or full automation.

[0147] exist Figure 1 The present invention depicts an embodiment of a system 10 for processing biological tissue 12 according to various aspects thereof, which is shown at a high level as an interconnected set of physical components.

[0148] In the described embodiment, the biological tissue 12 is a dynamic material comprising a patient 14 who is a living human being. The treatment includes one or more actions of a surgical procedure to be performed on the patient 14. The biological tissue 12 comprises soft tissue (e.g., cartilage) and hard tissue (e.g., bone), subsegments of which can be ablated by system 10 to create a resection surface, which, for arthroplasty, is ideal for prosthetic implantation. The so-called “dynamic” nature of the biological tissue 12 indicates that it may shift or move during surgery, and this needs to be taken into account in the ablation method to ensure that the surface is accurately targeted (discussed in more detail below).

[0149] System 10 can be referred to as the Intelligent Robot-Assisted Reduction Laser Ablation System (IRASLAS) TM And as will be described, it is operable to use computer-controlled robotic positioning, precise laser ablation, and sensors to evaluate the process and report the resulting geometry to perform one or more resections required for osteotomy, arthroplasty, or any other orthopedic or reconstructive surgery.

[0150] However, it should be understood that the present invention is not limited to the biological tissue being treated, the purpose of the treatment, or the actions performed during the treatment, and in alternative embodiments, the invention can be applied to treating additional and / or alternative materials, including dynamic and static materials, via treatments that include additional and / or alternative actions beyond those described. Depending on the embodiment, the material may be the body of a living organism or one or more parts thereof, or the body of an inanimate object or one or more parts thereof.

[0151] System 10 includes multiple components, subsystems and / or modules operably coupled via appropriate circuitry, computer chips (integrated circuits), transceiver / receiver antennas, software and connections to enable system 10 to advantageously combine the precision of computer-controlled devices with the fidelity of a laser when performing the functions and operations described herein.

[0152] To be precise, and as Figure 1 As shown, system 10 includes: a tool 24 operable to perform at least one treatment action; a positioning member 25 for positioning the tool 24 relative to biological tissue 12 and a guided laser beam 30 to perform the at least one treatment action required as part of a surgical procedure; a computing member, in this embodiment including a controller 100 and a storage device 18 storing electronic program instructions and information and / or data for controlling the controller 100; a display 20 for displaying a user interface 21 and an input member 22 for the surgeon 16 to interact with system 100; and hardware components stored in a basic unit 27 of the tool connected via a conduit 26.

[0153] The positioning member 25 may include any component or combination of components operable to move the tool 24 and / or biological tissue 12 relative to each other, such that the tool 24 can perform the at least one treatment action on the biological tissue 12.

[0154] In a preferred embodiment, tool 24 includes an end effector 28 operably attached to the working end of robotic arm 105, which includes positioning member 25. The end effector 28 is a hardware assembly comprising several components and sensors (as described further herein) to form and guide a laser beam 30 operable to perform actions required on biological tissue 12 during surgical procedures, and to sense the results. These actions include surgical ablation (removal of material).

[0155] The robotic arm 105 includes a manipulator 23 and a robotic arm controller 106, which is specifically designed to operate and control the manipulator 23. In an embodiment, the robotic arm 105 advantageously allows the end effector 28 to be optimally positioned and stabilized relative to the biological tissue 12 by the system 10, thereby enabling the proper execution of the at least one processing action. The robotic arm 105 is securely mounted to the base unit 27, thereby providing a sufficiently stable platform for the range of motion required during operation of the system 10. The robotic arm 105 has at least five degrees of freedom and includes safety features that allow it to be used in close proximity to a human by sensing resistance to movement. The robotic arm controller 106 is connected to a controller 100, which is operable to guide and monitor its activities.

[0156] The controller 100 operates under the control of electronic program instructions from the storage device 18 to receive input via input member 22, combine and interpret input including safety, positioning, surgical planning, and sensor data in real time, and process the input by utilizing and controlling sensing for precision control, safety and positioning, representation of biological tissue 12, and pending processing via machine sensing and other members, and controls positioning member 25 and tool 24 based on the processing to process biological tissue 12 under the supervision of surgeon 16. The biological tissue 12 is processed by performing at least one processing action on it using tool 24. In an embodiment, the controller 100 includes a computer system that enables system components to communicate and control system components.

[0157] In this embodiment, the components of system 10 required for the operation of tool 24 reside primarily in the housing including basic unit 27. These components, including laser-related components, particle filter-related components, water jet components, controller 100, sensor controller 103, dynamic focusing optics controller 137, storage device 18, hardware fault protection watchdog 175, control system, and power-related components of system 10, will be discussed in more detail below.

[0158] System 10 uses a positioning sensor 170, also known as a computer-assisted surgery (CAS) navigation sensor, to track the position and movement of the biological tissue 12 being treated in three dimensions. The positioning sensor 170 is operatively positioned at an elevated location, attached to a top plate, wall, arm, or standing position, providing a clear field of view of the biological tissue 12 and its surrounding environment. Several existing systems are commercially available and used in current surgical techniques. A typical procedure for computer-guided TKR involves inserting pins into the femur and tibia and attaching reference markers 70—an array of reflective markers that can be identified and oriented by the positioning sensor 170. Reference marker 70 position data is streamed from the positioning controller 171 to the controller 100 to aid in proper positioning and alignment of the resection. This input data is a primary method for understanding the position and movement of the biological tissue 12 being treated during surgery using system 10. The reference markers 70 are also attached to surgical instruments used in the surgery, serving as the current gold standard for positioning the resection in the correct location with proper alignment.

[0159] System 10 can also use a laser to mark one or more visually traceable patterns on biological tissue in an indelible manner, thereby creating laser-processed (i.e., laser-formed, e.g., laser-engraved) reference marks 71. A sufficiently high-speed (e.g., operating at frequencies greater than about 60 Hz) optical imaging sensor can provide high-resolution imaging, which System 10 can use to detect movement of the marks by comparison with previous images, particularly laterally from the tool's perspective, where the greatest risk lies in errors during the aiming at the biological tissue 12 used for ablation. The laser-processed reference marks 71 complement the tracking provided by the aforementioned reference marks 70.

[0160] The input to system 10 is adapted to the biological tissue 12 to be processed and the processing to be performed. In an embodiment, the input includes details and / or associated details of the biological tissue 12, the patient 14, the orthopedic surgical procedure, one or more components of system 10, and one or more of the surrounding environment. The details include relevant data and / or information.

[0161] The data and / or information may be obtained through one or more operations of retrieving, receiving, extracting, sensing, and identifying from one or more sources. The one or more data and / or information sources may be part of system 10, reside on a component of system 10 such as storage device 18, and / or be located or reside elsewhere remote from system 10.

[0162] The data and / or information includes: experimental and historical data; preoperative data, including coherent medical imaging of biological tissue 12 and patient 14, and clinical / surgical planning for patient 14; and data acquired during surgery via intraoperative sensing (discussed further below). The data and / or information may include joint kinematic data generated via gait analysis using at least one inertial measurement unit (IMU). An IMU is an electronic device operable to measure and report specific forces, angular velocities, and sometimes magnetic fields around the body using a combination of accelerometers and gyroscopes (and sometimes magnetometers). In embodiments of the invention, data and / or information may also be generated and / or obtained from devices including, for example, activity trackers (e.g., activity trackers provided under the trademark FITBIT™), smart braces, and smart splints.

[0163] In an embodiment of the invention, the display 20 for showing the user interface 21 and the user input component 22 are integrated into the touchscreen. In an alternative embodiment, these components may be provided as discrete elements or items.

[0164] The touchscreen display 20 is operable to sense or detect the presence and location of a touch within the display area of ​​the system 10. Input commands to the system 10 in the form of a "touch" sensed by the touchscreen display 20 are input to the system 10 as commands or instructions and transmitted to the controller 100. It should be understood that the user input element 22 is not limited to including a touchscreen, and in alternative embodiments of the invention, any suitable device, system, or machine for receiving input, commands, or instructions and enabling controlled interaction can be used, including, for example, a keypad or keyboard, pointing devices or composite devices, and systems including voice activation, voice and / or thought control and / or holographic / projective imaging.

[0165] Typically, the user is an individual with the appropriate knowledge, skills, and experience to use system 10 to perform treatments on biological tissue 12, such as an orthopedic surgeon 16 in this embodiment. The user is a trained medical professional who supervises and guides system 10 via the touchscreen display 20 of user interface 21.

[0166] The display 20 and user interface 21 are positioned in a convenient location close to the surgeon 16 to maintain good visibility and easy interaction.

[0167] Schematic Figure 2A A preferred embodiment of the tool 24, which is depicted as an end effector 28, includes various components and connections to other components in the base unit 27 via conduit 26.

[0168] The laser module 130 is operable to emit a coherent beam 30 at a predefined wavelength suitable for the ablation of biological tissue 12.

[0169] Laser current source 131 is operable to supply the current required to generate beam 30 to laser module 130. Controller 100 is operable to select different parameters in laser current source 131 to modify the resulting beam 30.

[0170] A cooling component in the form of a freezer 140 is operable to cool the laser module 130 via a circulating coolant 40 to prevent the laser module 130 and other components of the system 10 (including the scanning head 117 and water 55) from overheating, as discussed in more detail below.

[0171] The laser shield 133 is operable to prevent light from being accidentally emitted from the laser module 130 by using a switchable physical barrier that blocks the beam 30.

[0172] The laser mask controller 134 is operable to control the laser mask 133 to operate as directed by the controller 100.

[0173] The dynamic focusing optics 136 is operable to dynamically change the focal length and, via the dynamic focusing optics controller 137, focuses the beam diameter of the beam 30 at a target distance determined by the controller 100 as desired.

[0174] Mirror 33 is operable to reflect beam 30 in a aligned manner so that the dynamic focusing optics 136 can operate correctly. The mounting position of mirror 34 is adjustable to ensure that the alignment can be calibrated depending on the position of laser module 130 and the correct path to the dynamic focusing optics 136.

[0175] In a preferred embodiment, mirror 33 is partially reflective, making it operable to split the emitted beam 31 at a very small predetermined ratio to laser power sensor 128, which is operable to sense the power output of laser module 130. Controller 100 can calculate the total power output of laser module 130 by compensating for a known ratio of sensed emitted energy. In another embodiment, where dynamic sensing of laser energy is not required, mirror 33 may be fully reflective.

[0176] Mirror 34 is a dual-color filter operable to reflect light within the wavelength band of beam 30 into the beam inlet of scan head 117 and to emit light outside the wavelength band along optical path 32. The mounting position of mirror 34 is adjustable to allow for calibration of the reflection alignment depending on the path of beam 30 through dynamic focusing optics 136 and the correct path into scan head 117.

[0177] The current level of technology does not provide sufficient precision for the robotic arm 105 to be the sole method for guiding the laser beam 30 from the end effector 28 to the biological tissue 12 for ablation. A secondary method, employing fine motion components, allows for the directional aiming of the laser beam 30 with micrometer-level accuracy.

[0178] In a preferred embodiment, two galvanometer scanners are typically included, with the scanning heads 117 aligned with a mirror (not shown) as fine motion components, such as... Figure 1 The laser is rapidly re-aimed at by the scan head controller 160, operated by the fine motion controller 111. The scan head 117 typically has an f-θ lens that corrects the focal length across a flat target plane; however, since our target will be of arbitrary shape, the embodiment does not require an f-θ lens and instead uses a dynamic focusing optics 136. Other embodiments with different fine motion components, such as rotating polygonal mirrors, tilting / inclined mirrors, or Stuart platforms, will be discussed in more detail below.

[0179] Mirror 35 is operable to reflect the light path 32 to the sensor assembly 101 in a direct line of sight to the path of the laser beam 30. The mounting position of mirror 35 is adjustable to allow the reflection alignment to be calibrated with the path of the beam 30 and the sensor assembly 101.

[0180] The sensor assembly 101 includes multiple components that are required to sense and / or emit light along the same path as the laser beam 30 directed to the ablation target on the biological tissue. The sensor assembly 102 includes multiple components positioned on the surface of the end effector 28, operable to sense and / or interact with biological tissue or the environment from their own advantageous position. For safety, positioning, and precision shaping during surgery, it is required to non-invasively identify the biological tissue 12 prior to laser shaping. The sensors will be discussed in more detail below.

[0181] The light source 80 is operable to provide illumination so that the sensor array 101 / 102 can accurately and optimally sense the biological tissue 12 and the environment. For various sensors, such as the hyperspectral imaging sensor 180, which will be discussed in more detail below, this illumination will be operable across the range of wavelengths and modes of positive sensing.

[0182] A laser suitable for surgical ablation generates a beam 30 at a wavelength strongly absorbed by water (a common and abundant component of biological tissue 12). Water has a strong absorption peak at a wavelength of approximately 3 μm. Example laser sources operating within this specific wavelength range, and particularly suitable for laser ablation procedures such as those disclosed herein, comprise Er:YAG solid-state laser systems with an emission wavelength of approximately 2940 nm. The instantaneous heating of the water is the process by which material is ablated from the surface of the biological tissue 12. If there is insufficient water to effectively absorb the energy of the laser beam 30, the ablation effect is reduced, and the biological tissue 12 is at risk of merely carbonizing. If there is too much water, merely flash-boiling the water wastes too much energy, and the ablation effect is again reduced, however, the risk of carbonization of the biological tissue 12 is minimal. Given these two extreme cases, there exists an optimal amount of water such that most of the biological tissue 12 is ablated without carbonization, and the amount of energy used in the beam 30 is minimized.

[0183] When there is excessive water on the biological tissue 12, the system 10 of this embodiment does not have a direct way to reduce the water except by expending additional energy to vaporize it using the beam 30. An indirect approach would be to rely on the surgical team to use suction near the target point to remove some of the water.

[0184] It is easier to introduce additional water into the biological tissue 12 than to remove water. In a preferred embodiment, this includes a suitably sterile water supply 155 supplied via a consumable container or pipe, and said water supply is operable to provide water 55 for spraying onto the surface of the biological tissue 12 to be ablated.

[0185] In a preferred embodiment, the ejector liquid comprises a solution such as water or a water-derived solution or the like, as a skilled reader will understand. A suitable solution will preferably have strong absorption of light at the wavelength of the laser beam generated by the laser module 130, in order to achieve instantaneous heating of the ejector liquid, which assists the ablation process, making it more efficient, while simultaneously acting as a coolant for the biological tissue 12 to prevent carbonization of the biological tissue 12.

[0186] A guide member in the form of a water jet 157 is operable to flush the biological tissue 12. This advantageously allows for more efficient ablation and helps prevent carbonization of the biological tissue 12. In an alternative embodiment of the invention, a liquid may be used instead of water or as a supplement to water.

[0187] Compressed air supply 156 is operable to propel water 55 through water jet 167. In a preferred embodiment, this includes a compressor that obtains sterile air from the surgical environment, subsequently compresses the sterile air, and the compressed air 56 is injected into the water jet 157. In an alternative embodiment of the invention, a container or conduit supply may be used as compressed air supply 166.

[0188] The ablation of biological tissue 12 results in a plume 50 of vaporized and fragmented material ejected from the surface. This plume comprises sub-millimeter and submicron particles. Some of these fine particles pose a health hazard to surgical staff near system 10 and patient 14, as inhaled particles can damage the respiratory system. A preferred solution to this problem is that system 10 includes an extraction component to capture and filter the plume 50.

[0189] In a preferred embodiment, the extraction components include a particle collector 150, a particle filter 151, a fine particle filter 152, and a vacuum 153, operable to capture the plume and extract particles via filtration.

[0190] The particle collector 150 includes multiple openings operatively positioned near the location from which the ejected ablation plume 50 exits to ensure that it collects most or all of the particles. The plume 50 initially passes through a particle filter 151, which progressively filters out smaller particles—given the volume of the ablation material, it is important not to overcrowd a single high-efficiency (fine) filter. Filtered air 51, with significantly reduced particle volume, is then injected into a fine particle filter 152, which filters and retains any remaining, finer particles not captured by the particle filter 151. A vacuum 153 provides pressure to draw air into the filtration system, and the clean air 53 expelled from the fine particle filter is injected into the environment.

[0191] In a preferred embodiment, particle filter 151 retains most of the particles in the plume 50 and is the consumable filter shield 43 discussed in more detail herein, which can be replaced for each operation. Fine particle filter 152 includes a high-efficiency particulate air (HERA) filter.

[0192] Figure 2B Depicting the use during the surgical procedure Figure 1 or Figure 2A The system 10's end effector 28 is configured to reconstruct an instance of a patient's bone tissue. A laser beam 30 from laser module 130 impacts a biomaterial (e.g., bone) 12 with a spot size 64 defining an interaction zone 63. Typical spot sizes used for operation of the systems and methods disclosed herein range from about 300 to about 1000 μm to provide the necessary laser beam flux in the interaction zone 63 for effective operation of the system 10, for laser ablation processes of biomaterials 12 such as bone.

[0193] Schematic Figure 3 An embodiment of a tool 24 serving as an end effector 28 of system 10, utilizing a rotating polygonal mirror array 115 as an alternative fine motion component, wherein the rotating polygonal mirror array is composed of... Figure 1 The fine motion controller 111 is operated by the polygonal mirror array controller 161.

[0194] The polygonal mirror array 115 is a group of mirrors arranged at increasing angles around a polygon rotating at a precise constant speed.

[0195] The corners of the mirror mean that the light path 32 sweeps across several lines with stride distances between them (which somewhat resembles a square barcode with lines of equal width and spacing). Finally, after one complete rotation of the array, the light path 32 returns to the beginning of the first line, and the pattern repeats.

[0196] The controller 100 times the beam 30 pulses to coincide with the polygonal mirror array 115 when it is aimed at the surface location to be etched.

[0197] The advantage of this fine motion method is that the rotating polygonal mirror array 115 is simple and requires fewer expensive components.

[0198] The disadvantage of this method is that the controller 100 needs to wait until the polygonal mirror array 115 rotates to the desired aiming position and a set of etch patterns is present, which may be inconvenient for ideal etching in the minimum required time.

[0199] Schematic Figure 4 An embodiment of a tool 24 as an end effector 28 of system 10 is depicted, utilizing a tilting / tilting mirror 119 as an alternative fine motion component, the tilting / tilting mirror being... Figure 1 The fine motion controller 111 operates the tilt / tilt controller 162.

[0200] The tilting / tilting mirror 119 is a small device with a piezoelectrically controlled mirror at its end. The tilting / tilting mirror 119 can be angled in the X / Y axes.

[0201] This is similar to the 117 scanning head, but may be faster, with the downside of a lower aiming angle range.

[0202] In an embodiment of the invention using the tilting / tilting mirror 119, the tilting / tilting mirror 119 is aligned at 45° to the laser beam 30 such that when the tilting / tilting mirror 119 is in a “neutral” position, the laser beam 30 is reflected directly downwards (at 90° to the incident light path). In this way, the tilting / tilting mirror 119 redirects the laser beam 30 within a conical aiming range.

[0203] The main advantage of this technology is the near-instantaneous and precise aiming of the laser beam 30. The rapidly moving tilting / tilting mirror 119 means that the system 10 can reposition the laser beam 30 and fire laser pulses more quickly, resulting in the ablation of larger volumes of biological tissue 12.

[0204] A drawback is that the aiming cone's range is smaller than that of the laser scanning head 117. Placing the tilting / tilting mirror 119 as close as possible to the top of the end effector 28 to maximize the aiming angle would be advantageous, but this could also result in an outward-opening shield, thus weakening the protective effect of preventing the target from obstructing the laser beam 30.

[0205] The advantages resulting from the use of the tilting / tilting mirror 119 include: small inertial mass (the effect of acceleration is almost zero), rapid movement of the laser beam 30, and ease of implementation.

[0206] Schematic Figure 5 An embodiment of tool 24 as end effector 28 of system 10 is described, utilizing an actuator in the form of a Stuart platform 113, which can also be referred to as a "hexagonal block" and is composed of... Figure 1 The precision motion controller 111 is operated by the Stewart platform controller 163.

[0207] The Stewart platform 113 is a type of parallel robot with six prismatic actuators, which can be, for example, hydraulic connectors or electric actuators, attached in pairs to three locations on the base plate of the Stewart platform 113, spanning to three mounting points on the top plate of the Stewart platform 113. Items such as devices placed on the top plate can move in six degrees of freedom, making it possible to move the freely suspended body. These are three linear movements x, y, and z (lateral, longitudinal, and vertical), and three rotational movements: pitch, roll, and lateral turn.

[0208] Using the Stewart platform 113 provides a solution that allows for extremely precise XY linear movement, while the benefit of Z linear movement is the ability to maintain a set distance from the target surface profile as needed. Depending on the solution, it also allows for 30° angled and linear movement of the laser beam. Given sufficient load-bearing capacity, it may also allow for the direct mounting of other components and coverings.

[0209] The advantages provided by using the Stewart platform 113 include: a large range of motion; 3D movement (maintaining focus); and all tools (water jet 157, plume collector 150, laser module 130, and sensors of the sensor groups 101 and 102) maintaining the same movement.

[0210] Disadvantages may arise from using the Stewart platform 113, such as: inertial mass; acceleration and deceleration (complex laser control); complex implementation schemes in the overall system (minimum 12DOF); and confusion with other sensors on the end effector 28.

[0211] The main drawback of inertial mass has a significant impact on the amount of time spent guiding the laser beam 30 to the next target location on the biological tissue 12. The scanning head 117 or the tilting / tilting mirror 119 can target at least 400 laser pulses / second across any geometry, which the Stewart platform 113 cannot match.

[0212] The mass of the end effector means that even a moderate weight of a few kilograms can potentially cause momentum problems. Moving the platform with micrometer-level accuracy can cause it to "overshoot," as it may not be able to stop moving accurately and in a timely manner, or it may cause the opposite recoil problem. Some of these problems can be mitigated by having the end effector 28 catch up with the speed before ablation to keep it moving at a set speed and by firing the laser beam 30 in a timed manner (e.g., like a pendulum).

[0213] It should be understood that alternative laser power emission from the end effector 28 is possible. (See diagram) Figure 6 In an alternative embodiment of the invention depicted, instead of mounting the laser module 130 in the end effector 28, it is possible to emit the light beam 30 from the laser module 130 mounted within the base unit 27 to the end effector 28 via an optical fiber 36 having fiber-coupled optics 138. The use of the optical fiber 36 should only be considered as a preferred embodiment of standard methods for emitting laser energy, which include (but are not limited to) waveguides or articulated arms.

[0214] Similarly, in the diagram Figure 6 In an alternative embodiment of the invention depicted, the sensor group 101 may be housed in the basic unit 27, and the optical path 32 is emitted from the end effector 28 via the optical fiber 36.

[0215] The advantages of this alternative approach include requiring less space in the end effector 28 and reducing weight. Depending on the components that need to be incorporated into the end effector 28, physical space may not be available, or the required alignment with the dynamic focusing optics 136 may not be feasible. In such embodiments, instead of wide cabling for carrying power and water from the base unit 27, only a single thin optical fiber 68 is required.

[0216] This advantage may be minimal in embodiments requiring, for example, wiring for drawing and sterilizing air / water.

[0217] It should be noted that at the end effector 28, there may be more complex coupling optics required to inject the laser beam 30 into the fiber 36 and decouple the laser beam 30 back from the fiber 68. There may also be considerable laser power loss due to coupling via the fiber. Generally, the fiber 68 itself can have 25% power loss, and the required coupling / decoupling optics can contribute another 23% loss. These factors mean that a more powerful laser current source 131 is needed, which in turn has higher cost and operating power requirements. Furthermore, optical fibers are generally fragile and will break if bent too far or impacted with sufficient force.

[0218] Schematic Figure 7 Embodiments of sensor groups 101 and 102 in end effector 28 are depicted, having a connection via conduit 26 to an associated controller in sensor group controller 103 in base unit 27. It should be noted that in some embodiments, the sensors may be located in sensor group 101, operatively positioned to sense light in the line of sight of light path 32, and / or from another advantageous point as part of sensor group 102 to sense biological tissue.

[0219] During the process of providing input to and being guided by controller 100, individual sensors may be operated to monitor, sense, and collect or measure sensor data and / or information that are associated with or related to one or more characteristics, properties, and / or parameters of system 10, biological tissue 12, patient 14, surrounding environment, components, systems, or devices associated with or connected thereto.

[0220] The guide laser 122 allows the system 10 to provide visual feedback to an observer (e.g., surgeon 16 and members of the surgical team) regarding the proposed ablation target area on the biological tissue 12. This advantageously increases the user's confidence in the system 10 by clearly providing visual feedback about the biological tissue 12, rather than solely via the display 20. Without the guide laser 122, it may sometimes be unclear what exact location the system 10 is planning to ablate or is currently ablating, as the ablation laser beam 30 is invisible to the naked eye in this embodiment. The guide laser 122 is operated by the controller 100. The guide laser is a visible light laser, and in a preferred embodiment, the guide laser is a red laser.

[0221] The Raman spectroscopy sensor 182 is operable to observe vibrations, rotations, and other low-frequency patterns in biological tissue 12, as guided by the controller 100 via the Raman spectroscopy controller 183.

[0222] Raman spectroscopy relies on the inelastic scattering of monochromatic light, typically from a laser source, and is operable to provide additional information from a single point on biological tissue 12. System 10 is operable to use Raman spectroscopy for material identification in surgical procedures. In addition to acting as a guide, the beam of the aforementioned guiding laser 122 serves a secondary purpose as a red laser source for Raman spectroscopy. During Raman scattering, a small fraction of the red laser beam photons are inelastically scattered, meaning they lose energy to the molecules that make up the target sample. The amount of energy lost per photon is related to the vibrational energy of the molecules. Thus, for example, bone containing hydroxyapatite (Ca5(PO4)3(OH)) and PO bound together has a diameter of 959 cm. -1 The characteristic Raman line at the site. The presence of this line in the Raman scattered light indicates that the guiding laser 122 is on the bone. Depending on the processing action to be performed and the analysis and control decisions made (discussed in further detail below), if the bone is the target and other conditions are met, the controller 100 can be operated to activate the laser beam 30 and ablate the biological tissue 12. Furthermore, other joint tissues, such as cartilage and ligaments, have similar characteristic Raman spectra that allow them to be identified.

[0223] The microscopic sensor 186 is operable to provide detailed magnified visual images of the biological tissue 12, as guided by the controller 100 via the microscopic controller 187. The system 10 is operable to use the information collected by the microscopic sensor 186 to assist in the detection of components of the biological tissue 12 by visual comparison with known samples. The resulting detailed resolution images can also be provided to the surgical team to offer a better viewpoint of targets that might not be visible from a vertical orientation, given the necessity of positioning the end effector 28.

[0224] The hyperspectral imaging sensor 180 is operable to detect the intensity and frequency of reflected or absorbed light across a broad spectrum (beyond the visual range), as guided by the controller 100 via the hyperspectral imaging controller 181. A sample of reflected light can be obtained by illuminating the target with a light source 80 that covers the spectral range of the hyperspectral imaging sensor 180, in a preferred embodiment using a spectral range of 400 nm to 1000 nm.

[0225] Different intensities contain characteristic signatures, which are used by system 10 to predict the type and components of biological tissue 12. This prediction can be performed using machine learning, as will be described in more detail.

[0226] Hyperspectral data can be used in conjunction with machine learning to identify the type, properties, and components of biological tissues12

[0227] Thermal sensor 184 is operable to detect radiation in the mid-to-long infrared range of the electromagnetic spectrum to determine the temperature of biological tissue 12, as guided by controller 100 via thermal sensor controller 185. During and after laser ablation, system 10 is operable to non-invasively assess thermal shock, and the results can be used to optimize the selection of laser parameters in subsequent ablation processes.

[0228] Optical imaging sensor 188 is operable to provide visual images of biological tissue 12. These images can be analyzed to aid in the prediction of the type and composition of biological tissue 12. It can also be used at high speeds to track targets in the field of view, such as those guided by controller 100 via optical imaging controller 189. The aforementioned laser-processed reference marker 71 can also be tracked using the optical imaging sensor.

[0229] The 3D measurement sensor 190 is operable to detect the geometry of the surface of the biological tissue 12, as guided by the controller 100 via the 3D measurement controller 191. The information collected by it is used by the system 10 to determine the geometry of the surface without contact. The geometry of the surface of the biological tissue 12 is extremely important for the system 10 to determine the shape before and after ablation.

[0230] Several different types of techniques exist for sensing 3D geometry, including time-of-flight, laser triangulation, structured light projection, and modulated light. To achieve the required micrometer-level resolution, system 10 uses structured light projection, line profile sensors, or point profile sensors (e.g., chromatic confocal sensors). In one embodiment, a structured light scanner projects a light pattern onto an object, and two offset cameras examine the deformation across the surface—a process that takes fractions of a second and can quickly scan relatively large areas. In a preferred embodiment, a chromatic confocal sensor is part of the sensor group 101 and acquires readings as finely moving components cross the surface through the light beam 30, thereby establishing the complete geometry over time.

[0231] Optical coherence tomography (OCT) sensor 192 is operable to capture micron-resolution three-dimensional images of biological tissue 12, as guided by controller 100 via OCT controller 193. OCT uses light to capture micron-resolution three-dimensional images based on low-coherence-interference measurements. This allows it to penetrate scattering media, such as biological tissue, to approximately 1000 to 2000 μm below the surface of biological tissue 12 to obtain data on the underlying structure of the tissue to be ablated. The system uses the data obtained from OCT sensor 192 as a mechanism to detect surface and underlying tissue components for planning the ablation process, achieving maximum ablation efficiency and minimal thermal impact on surrounding tissue (which could lead to thermally induced damage to surrounding tissue).

[0232] When ablation occurs, system 10 will be unable to sense the environment within the same microsecond timeframe, and there is a risk that the targeted material may differ from the expected material or that foreign objects may be introduced into beam 30. One possible way to mitigate this risk, and one utilized in this embodiment, is to use an acoustic sensor 178, operable to measure pressure waves from the environment and the surrounding biological tissue 12. (Reference) Figure 28 Method 2800 measures the dissimilar pressure waves exerted by the laser beam 30 on the ablated material (e.g., biological tissue 12), and through analysis of the measured data, system 10 can be operated via acoustic controller 179 to determine in real time whether unintended material has been hit. The sound of hard biological tissue differs from that of soft biological tissue and any other type of material. By examining (preferably, consistently) the sound of previous pulse ablation, if any sound is encountered that is inconsistent with the expected sound of the material type targeted for ablation, it is possible to stop the operation of system 10. This safety feature does not prevent the first laser pulse from hitting unintended material, but it prevents subsequent laser pulses that would otherwise occur before any overall resensing.

[0233] The sensing technology described above is used in embodiments of the present invention to identify and monitor biological tissue 12, and is combined with shaping laser operation to achieve a safe, highly accurate and precise system 10 under intelligent control.

[0234] As will be described in more detail, system 10 is operable to perform ablation laser ablation, taking into account one or more relevant factors, including thermal shock (i.e., the biomass of residual tissue – non-local), the biocomposition of the bone being ablated, the flatness of the residual surface, planar alignment, and relation to mechanical axes (global alignment). The laser beam 30 can also ablate defined channels or cavities in the bone, or other suitable shapes that will allow / accommodate an implant / prosthesis or one or more parts or components 13 thereof, as illustrated in the figure. Figure 8 As depicted in the text, Figure 8 The matched resection of the joint ends of the tibia and femur is shown 60.

[0235] In addition to bones, the laser beam 30 can also be operated to cut all human tissues, including the patient's skin, muscles, fat, meniscus, tendons, connective tissue, articular cartilage, cysts, ligaments and fascia.

[0236] The reference diagram is shown below. Figure 9 Description of consumable filter shield 43.

[0237] In this embodiment, the end effector 28 operates at a distance between 150 and 300 mm from the biological tissue 12. This distance is within the common operating range of the sensor and the beam fine motion component, and it also allows for a physical gap from which the ablation plume can exit without immediately enveloping the outer surface of the end effector 28 (which would cause contamination).

[0238] However, while the distance helps prevent contamination, it increases the risk of providing space for the target (and more precisely, parts of the human body other than patient 14) to be accidentally positioned between the end effector 28 and the biological tissue 12. The main danger is that the laser beam 30 could damage the soft biological tissue (of the human body other than patient 14) that happens to be blocking the target when the laser beam is fired. Although the risk of injury decreases exponentially with increasing distance from the focal point of the laser beam 30 (because of the energy density or flux in joules (i.e., per cm⁻¹)...) 2 While the laser energy is reduced as it moves away from the focal point, it still poses a risk to members of the surgical team during surgery. Another risk is that reflective or mirror-like non-human objects can cause specular reflection of the laser energy. However, this is a very small risk, as any reflected laser energy will most likely be scattered rather than focused; in this embodiment, additional protection of the eyes by surgical staff is mandated during use with safety goggles.

[0239] To create a physical barrier over the danger zone defined by the vertical space between the biological tissue 12 and the end effector 28, the system 10 includes a shield for providing protection, which in an embodiment takes the form of a conical consumable filter shield 43 with an open end. The larger open end of the consumable filter shield 43 is attached to the end effector 28 via an attachment point 45, thus firmly holding the consumable filter shield 43 in place. The smaller open end of the consumable filter shield 43 provides space or gap between itself and the target biological tissue 12. This gap is advantageous in that it allows for easy visual inspection by the user of the system 10 (e.g., surgeon 16) during ablative action; acts as a preventative measure against collision between the displaced biological tissue 12 and the consumable filter shield 43; and allows for workspace for, for example, retractors, suction, irrigation, or other surgical instruments.

[0240] Water 55 (or a suitable alternative) is applied to the biological tissue 12 via a plurality of water jets 157, which are operable to enhance the ablative process and act as a coolant for the biological tissue 12.

[0241] As mentioned above, the fine particles of the ablation plume 50 pose a health hazard to personnel and patients 14 of system 10, as inhalation of these particles can damage the lungs. A preferred solution to this problem is that the consumable filter shield 43 includes a particle collector 150 in the form of multiple openings, operatively positioned relatively close to the location from which the ablation vapor is ejected, to ensure that it collects a majority of the particulate material from the plume 50. A vacuum 153 draws the plume 50 into the particle collector 150 and into a spiral conduit 46 surrounding the consumable filter shield 43.

[0242] The consumable filter shield 43 is operable to direct compressed air 56 away from the smaller open end, serving as a plume control component 149. The compressed air 56 directs the plume away from the beam 36 and toward the particle collector 150.

[0243] The initial method for filtering and collecting abraded material is via a series of "traps" and filters 151 constructed into a spiral conduit 46 around a consumable filter shield 43. Thus, the consumable filter shield 43 is not a suitable single-layer material (e.g., plastic), but has an outer and inner layer. In such embodiments, as shown in the figure... Figure 9 As shown, the tilt separator can thus have a series of angled filters 151, which will allow progressive filtration (from largest to smallest particles) of the abrasive material and collect the abrasive material in an area away from the guided suction airflow.

[0244] The cross-section of the particle collector 150 is preferably extremely narrow. This results in a high airflow rate (i.e., a strong vacuum). As the spiral conduit 46 travels upward along the consumable filter shield 43, the height of the spiral conduit 46 can increase. This, in turn, reduces the airflow as the cross-section increases, and heavier abrasive material will slow down and fall to the bottom of the spiral conduit 46. Through an angled filter having a trap 151 positioned along the spiral conduit 46, the abrasive material will accumulate without sliding back down. By controlling the rate of increase in the cross-section of the spiral conduit 46, the volume of abrasive material collected at each point can be controlled based on studying the relative percentage distribution of the abrasive material density. Preferably, the cross-section of the spiral conduit 46 increases significantly as it reaches the cavity in which the vacuum tube is connected, and even fine abrasive material can be collected.

[0245] In this embodiment, by collecting a portion of the ablative material in the consumable filter shield 43 for disposal after each procedure involving system 10, the total ablative material required to be collected by the fine particle filter 152 is reduced. Approximately 60 cm of the ablative biological tissue 12 is ablated in a given TKR. 3In this case, this advantageously extends the service life of the more expensive fine particle filter 162, which would otherwise be clogged by abrasive material in a very short time.

[0246] Schematic Figure 10 An embodiment of the basic unit 27 is depicted, which contains all the devices and consumables that constitute system 10 but are not mounted in the end effector 28. Some of these devices are large and heavy, making it ideal to position them low within the basic unit 27 to lower the center of gravity and stabilize system 10 for easy operation.

[0247] The communication and conduit with the end effector 28 is via a bundled cable, which is secured to or within the robotic arm 105. Specifically, the bundled cable contains power 41; coolant 40 (in / out); partially filtered air 51; water 55; compressed air 56; control wiring and / or fiber optic components 36. By dividing the cable bundle into insulated conduits, coolant 40 from the chiller 140 can be tightly compacted with the water 55 conduit along the length of the bundled cable. This advantageously allows the water 55 to be cooled solely by means of its arrangement within the bundled cable, thereby reducing the complexity of the system 10 and eliminating the need for a separate cooling process for the water 55.

[0248] Schematic Figure 11 A cross-section of the biological tissue 12 is depicted, with the planned excision 60 marked as a dashed line. The amount of material to be eroded above the line indicates the amount of biological tissue 12 above the line, while the material below the line should remain undamaged.

[0249] Each laser pulse ablates a very small volume of material. Given that a complete resection requires a very large volume to be ablated, it is evident that a very large number of laser pulses would be required.

[0250] For a resection 60 to be completed within the required time period, the system 10 of the embodiment preferably executes these laser pulses almost as quickly as the generated attenuated laser beam 30 and the fine motion components will allow.

[0251] However, there are conflicting requirements to perform ablation safely and accurately. The dominant method by which system 10 senses the biological tissue 12 and its surrounding processing environment is by utilizing the imaging or scanning sensors of the sensor groups 101 and 102. This provides system 10 with a rich dataset to confidently analyze and determine the points where laser pulses are guided to ablate the correct material and where no other material is present in the path. However, some of the imaging and scanning sensors of sensor groups 101 and 102 take tens to hundreds of milliseconds to sense their environment. If system 10 uses these sensing methods between each laser pulse, an unacceptable amount of time will be spent completing the resection 60. Therefore, resenting the biological tissue 12 between each single laser pulse in the described embodiment is undesirable.

[0252] The solution of this embodiment is to divide the laser pulses into batches of ablation processes 62, each ablation process 62 comprising a set of pre-calculated pulses across different locations on the surface of the biological tissue 12. The system 10 is operable to perform each ablation process 62 after sensing the environment. Resection is performed in multiple ablation processes 62, which progressively reduce the tissue surface until the desired final resection 60 is achieved. This operation provides an optimal balance between sensing (guarantee) and speed.

[0253] like Figure 11 As depicted, the risk of incidental tissue damage is greatest around the edge of the volume of the eroded biological tissue 12, indicating the danger of beam 30 missing its target. Furthermore, the risk of surface tissue damage is greatest near the final resection position 60, indicating the danger of continuing to erode the surface beyond the ideal point.

[0254] The laser parameters of system 10 will now be described.

[0255] System 10 interacts with the surgical environment via a plurality of actuators, including a laser module 130, a fine motion component (in a preferred embodiment, a laser scanning head 117), a robotic arm 105, a plume control 149, and a water jet 157. Each of these components has a plurality of control parameters. These control parameters include:

[0256]

[0257] The ranges listed immediately following each parameter in the table above are estimates of the upper, lower, and typical ranges for each parameter in an embodiment where a reasonable resection is expected to be performed.

[0258] The laser parameters include: average output power (in watts) - the laser power of the generated beam 30; pulse duration (in microseconds) - the amount of time for each pulse of the laser to be generated; spot size (in micrometers) - the diameter of the focused beam 36; energy density (in joules per square centimeter) - the laser energy delivered per unit area; and pulse frequency (cycles per second) - the number of pulses generated per second.

[0259] For flat plane ablation with a circular beam profile, in order to produce a smooth surface, laser ablation must overlap in a pattern or grid so that the surface is reduced uniformly.

[0260] The inventors’ indicative research shows that beam diameters of 200 to 600 micrometers and overlapping patterns are sufficient to produce flat etched surfaces.

[0261] This means that any given point on the surface will be eroded multiple times simply due to overlap, even before any consideration of the desired erosion depth. This necessitates a rapid method for firing a laser beam 30 at the surface.

[0262] Schematic Figure 12A An example of a preferred laser beam ablation channel size is depicted. When creating a channel, the beam diameter or spot size 64 indicates the channel width by the overlap of subsequent pulses with the first pulse (with a gap 65). By continuing in this manner, ablation channels are created in the material. To produce a final flat surface, multiple channels can be created, with strides 66 between them to allow removal of the sides of the channels.

[0263] However, the cumulative thermal shock from multiple laser pulses across the surface in this manner could damage the biological tissue 12, which is particularly undesirable in the final removal of the 60 surface.

[0264] Alternative ablation patterns are staggered grids of laser pulses spanning the surface, such as... Figure 12B As depicted in the text.

[0265] The first series of pulses 74, marked with "1", are spaced apart to prevent the accumulation of thermal shock in the same local area. The second series of pulses 75, marked with "2", are spaced apart from the first series. The third and fourth series of pulses 76 and 77, marked with "3" and "4" respectively, overlap and ensure the surface between the first and second series is intact. In this way, optimal coverage is achieved with minimal thermal shock.

[0266] Schematic Figure 13 Describe the architecture of the controller.

[0267] The controller 100 includes system management software running on a computer. The controller 100 further includes software for managing the system 10. Optionally, the controller 100 further includes an artificial intelligence control system operable to integrate and interpret real-time received input to the operating system 10.

[0268] The responsibilities of controller 100 include the following areas: communicating with the hardware components of system 10; processing various information to determine the action to be taken in a given situation; transmitting the current operating status of system 10 to user interface 21; and loading and storing data to and from storage device 18.

[0269] Specifically, controller 100 is operable to utilize and control: sensors of sensor groups 101 and 102, one or more of a plurality of representations concerning biological tissue 12 and the processing to be performed, machine sensing, robotic arm 105, and laser-related components. In this way, controller 100 is operable to perform actions based on decisions made and commands received.

[0270] The controller 100 includes a processing component in the form of a processor.

[0271] Storage device 18 includes read-only memory (ROM) and random access memory (RAM). Specifically, storage device 18 provides patient-specific data and surgical planning for system 10 to perform.

[0272] System 10 is capable of receiving instructions that can be stored in ROM or RAM and executed by a processor. The processor is operable to perform actions under the control of electronic program instructions, as will be described in further detail below, including processing / executing instructions and managing data streams and information through system 10.

[0273] In this embodiment, the electronic program instructions of system 10 are provided via software stored on storage device 18. As will be described in more detail, system 10 is operable to perform functions via software, including: extracting, transforming and combining data, and recording all real-time data passing through system 10.

[0274] All collected data and information are distributed within System 10 for use as described herein.

[0275] System 10 also includes an operating system capable of issuing commands and configured to interact with software, causing the system to perform corresponding steps, functions, and / or procedures according to embodiments of the invention described herein. The operating system is suitable for system 10.

[0276] System 10 is operable to communicate via one or more communication links, which may be connected in various ways to one or more remote devices, such as servers, personal computers, terminals, wireless or handheld computing devices, terrestrial communication devices, or mobile communication devices such as mobile (cellular) phones. At least one of the multiple communication links may be connected to an external computing network via a telecommunications network.

[0277] The software and other electronic instructions or programs for the computing components of system 10 can be written in any suitable language, as is well known to those skilled in the art. In embodiments of the invention, the electronic program instructions may be provided as a standalone application, as a set of or multiple applications, via a network, or added as middleware, depending on the requirements of the implementation or embodiment.

[0278] In alternative embodiments of the invention, the software may include one or more modules and may be implemented in hardware. In this case, for example, the module may be implemented using any one or a combination of the following techniques (each well known in this art): discrete logic circuits having logic gates for implementing logic functions on data signals, application-specific integrated circuits (ASICs) having appropriately combined logic gates, programmable gate arrays (PGAs), field-programmable gate arrays (FPGAs), etc.

[0279] The computing component can be any suitable type of system, including: programmable logic controllers (PLCs); digital signal processors (DSPs); microcontrollers; personal, laptop, or tablet computers, or dedicated servers or networked servers.

[0280] The processor can be any one or a combination of the following: one or more custom or commercially available processors, a central processing unit (CPU), a graphics processing unit (GPU), a data signal processor (DSP), or an auxiliary processor, and several processors associated with the computing component. In embodiments of the invention, the processing component can be, for example, a semiconductor-based microprocessor (in the form of a microchip) or a large-scale processor.

[0281] In embodiments of the invention, the storage device may include any one or a combination of the following: volatile memory elements (e.g., random access memory (RAM), such as dynamic random access memory (DRAM), static random access memory (SRAM)); and non-volatile memory elements (e.g., read-only memory (ROM), erasable programmable read-only memory (EPROM), electronically erasable programmable read-only memory (EEPROM), programmable read-only memory (PROM), magnetic tape, compressed optical disc read-only memory (CD-ROM), etc.). The corresponding storage device may incorporate electronic, magnetic, optical, and / or other types of storage media. Furthermore, the storage device may have a distributed architecture, in which various components are remotely located relative to each other but accessible by a processing component. For example, the ROM may store various instructions, programs, software, or applications executed by the processing component to control the operation of the system 10, and the RAM may temporarily store variables or results of said operations.

[0282] The use and operation of computers using software applications are well known to those skilled in the art and need not be described in any further detail herein unless relevant to this invention.

[0283] Furthermore, any suitable communication protocol may be used to facilitate connection and communication between system 10 and any subsystems or components of other devices or systems, including wired and wireless connections and communications, as is well known to those skilled in the art and need not be described in any further detail herein except in connection with the present invention.

[0284] When the words “store,” “hold,” and “preserve,” or similar words are used in the context of this invention, they should be understood to include referring to data or information being permanently and / or temporarily retained or held in a storage element, device, or medium for later retrieval, as well as temporarily or momentarily, for example, as part of a processing operation being performed.

[0285] Furthermore, when the terms “system,” “device,” and “machine” are used in the context of this invention, they should be understood to include any group of functionally related, interactive, interdependent, or associated components or elements that can be located close to, separated from, integrated, or discretely positioned with each other.

[0286] Furthermore, in embodiments of the present invention, the term "determine" should be understood to include receiving or accessing relevant data or information.

[0287] The system coordinator 200 covers the entire controller 100 and forms the "backbone" of organizing and interconnecting all software components of the system 10.

[0288] The responsibilities of the system coordinator 200 include, and it is operable to, perform the following: configure the components of system 10; manage the lifetime of the components; provide runtime services to the components; and enforce overall system security.

[0289] The components of the system 10 that facilitate operation under the guidance of the system coordinator 200 include: a fine motion component 204; a robot motion component 202; a laser control component 206; a planning component 208; a bioanalysis component 210; a laser optimization component 214; a mapping component 212; and a resection surface analysis component 216.

[0290] More specifically, the system coordinator 200 is operable to facilitate the following functions.

[0291] Configuration: The operation of system 10 is determined by a specific set of components included and configured by system coordinator 200.

[0292] Component Type: Each component of System 10 has a designated interface used by System Coordinator 200 to access its functionality. Because System Coordinator 200 controls the configuration and initialization of components, it is possible for any component to be replaced by a specially crafted alternative that implements the component's interface but performs a different function. This is useful for activities that include development, testing, verification, quality control, and simulation.

[0293] Development: In the early stages of development of System 10, most components may exist in a form that does not perform any actual functions but exists purely to meet interface requirements (having non-functional "stubs"). These "stub" components allow the System Coordinator 200 to facilitate the development of specific single field components, while the rest of System 10 remains functionally neutral.

[0294] Simulation: A model that creates a simulation of a component, "replaying" pre-recorded or manufactured functionality and data. The primary purpose of this type of component is to support integration testing and functional verification under both success and failure scenarios. A secondary purpose of this type can be the re-creation and analysis of previously recorded field processes.

[0295] Site: A single site configuration exists for each component used in the production construction of an embodiment. This provides the real-world functionality required for the deployed product.

[0296] Management: The System Coordinator 200 is operable to manage the operation and lifespan of each component.

[0297] Component isolation: The runtime environment of each component can be set and controlled by the system coordinator 200 depending on the specific purpose and circumstances. For development, each component may be executed serially to aid debugging and simplify data flow for deterministic timing. However, for testing, verification, and field environments, it is possible to set up a separate processing thread for each component to allow for finer control over time-critical functionality.

[0298] State Management: The system coordinator 200 is operable to maintain the state of system 10 as it transitions between tasks. This will invoke various functionalities in each component as needed for the current operation of the task at hand.

[0299] Component Coordination / Data Flow: In this embodiment, data is not sent directly between components, but rather via system coordinator 200. This allows for loose coupling between components, facilitating easier development and testing. It also provides insertion points where system coordinator 200 can perform additional functions on the data during transmission, such as full inspection, logging, and data recording.

[0300] Runtime services: In this embodiment, each component needs access to global functionality that is common and synchronized across system 10. This may also include platform-dependent functionality of underlying services. This set of functionality is provided to each component by the system coordinator 200.

[0301] Entry: Centralized entry allows each component to provide runtime status information that can be directed to several different destinations, such as the console, log files, or databases. This entry can be configured by the system coordinator 200 to rigorous, detailed, and granular levels.

[0302] Data logging: For any specific process in System 10, the data flow between components can be logged to a database for later analysis, verification, or replay. This data logging can be used to configure simulation components in later processes.

[0303] Timing (High-Resolution Clock): Several operations of System 10 require accurate timing. A high-resolution clock is provided, operable to allow timing at least at the microsecond level. When System 10 is in analog mode, this clock can be synchronized with external sources such as provided data recordings.

[0304] Safety: Safety of System 10 is paramount, and in the described embodiment, System Coordinator 200 is ultimately responsible for enforcing the fault protection procedure. When a safety issue is detected, System Coordinator 200 is operable to ensure that each component enters orderly fault protection, and that System 10 is placed in a safe posture for further instruction from personnel. Several ways in which System Coordinator 200 can detect issues that would cause System 10 to enter fault protection are described in more detail.

[0305] Active component failure: In this embodiment, each component may actively report a failure to the system coordinator 200, which will initiate system failure protection. This may be attributed, for example, to one or more of the following: detected hardware failure, operation outside of safety parameters, or unexpected or unknown operational situations.

[0306] Component passive failure: In this embodiment, each component consistently reports correct operation and function. If a component fails to report in a timely manner within the required specifications, the system coordinator 200 may operate to consider it to be in an undesirable, unhealthy, or unknown state and initiate fault protection.

[0307] The system coordinator 200 does not consider itself faultless and, in this embodiment, must report its own correct operation to an independent hardware device, referred to herein as watchdog 175, which will reset a hardware timer upon receiving each successful report. If the system coordinator 200 fails to report within the required time period, watchdog 175 can operate to trigger a hardwired shutdown of all hardware in system 10. For the robotic arm 105, this may include safety circuitry, and for the laser subsystem, this may include activating a shield and disabling associated power relays.

[0308] Regarding the watchdog 175, the system 10 of the embodiment cannot rely solely on the correct operation of the controller 100 software, the base operating system, the driver, or the hardware. There is always a possibility of failure in any of these layers, which may or may not be detectable by the running software.

[0309] Schematic Figure 14 A flowchart depicting the method 1400 for describing the actions taken during the watchdog (hardware fault protection) procedure of system 10.

[0310] The watchdog 175 is initiated by the controller 100 during system 10 initialization 1401. It is configured with a safety threshold (in microseconds) 1403 and the timer is reset to zero 1405.

[0311] For each reading from the high-resolution real-time clock, the amount of time elapsed is incremented by 1407 to the timer. The timer represents the number of microseconds that have elapsed since System 10 last reported itself to be in a known good state.

[0312] The timer is compared with the safety threshold 1409.

[0313] If it has not yet exceeded the threshold, it will loop back to check if it has received the 1411 timer reset signal from controller 100. When a reset signal is received, the timer is reset back to zero.

[0314] If it exceeds the threshold, the fault protection shutdown process 1413 is initiated. For system 10 of the described embodiment, this includes activating emergency stop 1415 on two components with critical risk: laser current source 131 and robot arm 105 (robot arm controller 106). This action will immediately stop the laser beam 30 from firing and prevent the robot arm 105 from moving.

[0315] Figure 15 A flowchart depicting the method 1500 for actions performed by the system coordinator 200.

[0316] System coordinator 200 starts from a paused state.

[0317] The surgeon 16 loads a plan 1502 for the action to be performed from the storage device 18 into the guidance system coordinator 200 1501. The plan 1502 consists of patient-specific data 1504 and surgical procedure data 1506.

[0318] If surgeon 16 chooses to restart system 10 and a plan has been loaded, plan 1502 will be executed by the running planning process 1503.

[0319] During the planning process 1503, the hardware fault protection watchdog 175 continuously sends a 1505 "all OK" signal, which prevents the fault protection from being activated. If the system coordinator 200 fails to send a signal within the threshold timeout period, the system 10 is considered to be in an unknown state, and the hardware is set to a safe state, as described above in reference method 1400.

[0320] In this embodiment, the input processing performed by the system coordinator 200 includes input analysis and decision-making based on the analysis. Once a decision has been made, the system coordinator 200 can operate to control the robotic arm 105 and the laser to process the biological tissue 12 based on the decision-initiated action.

[0321] As part of the analysis, the system coordinator 200 is operable to generate and / or receive, as input, at least one first representation of the biological tissue 12. In an embodiment, the at least one first representation of the biological tissue 12 includes a representation of a first or pre-action (initial) state of the biological tissue 12 corresponding to its actual state before the at least one processing action is performed on the biological tissue. The at least one first representation of the biological tissue 12 includes parameters that describe or provide indications of one or more characteristics of the biological tissue 12.

[0322] In an embodiment, the at least one first representation of the biological tissue 12 includes a map or model of the pre-action state of the biological tissue 12.

[0323] Figure 16A flowchart depicting a method 1600 for actions performed during the mapping operation of a system 10 to generate a map.

[0324] The system 10 of this embodiment needs to understand the 3D surface and components of the biological tissue 12 and its surrounding environment. This representation of physical reality is used by several subsystems of system 10 to infer and plan the actions to be performed. Importantly, the accuracy of the mapping is sufficient to enable system 10 to safely and correctly perform the resection of hard biological tissue.

[0325] There are several ways in which system 10 senses the map drawing information required, as follows.

[0326] As described herein, system 10 is operable to organize all this information and incorporate it into the cohesive model, so that parts of system 10 can be inferred given their own requirements.

[0327] The at least one first representation may include a plan for a process to be performed, which may include the setting of parameters that define one or more features or characteristics of the process.

[0328] The system 10 of the embodiment is operable to use planning components to coordinate the actions required to properly perform necessary actions, including, in the embodiment, the resection of a surgical procedure.

[0329] Figure 17 A flowchart depicting the method 1700 for the actions performed during the planning operation of system 10.

[0330] The planning process controls the sequential actions that occur when following the plan 1502 loaded from the storage device 18.

[0331] The next step is retrieved from the plan 1701, and the matching step process is executed.

[0332] Repeat this process until all planning steps have been completed. In an embodiment, the planning steps may include:

[0333] Waiting operation step 1703; landmark alignment operation step 1705; material positioning operation step 1707; standby positioning operation step 179; and prosthesis removal operation step 1711.

[0334] Figure 18A flowchart depicts a method 1800 of actions performed during a landmark alignment operation in system 10. The landmark alignment process involves the stepwise alignment of points in three-dimensional space by surgeon 16 using a tool with attached reference markers 70. As the user interface 21 prompts for each point, position sensor 170 determines the position of the working end of the tool. In an embodiment, in the context of a surgical procedure on the knee of patient 14, the points sequentially comprise the following locations 1801 between the start and end of the landmark alignment process: femoral mechanical pivot point; medial epicondyle; lateral epicondyle; lateral anterior femoral cortex; white border line; surface of medial femoral condyle; surface of lateral femoral condyle; medial malleolus; lateral malleolus; anterior tibial point; medial tibial condyle; lateral tibial condyle; and tibial inclination.

[0335] Figure 19 A flowchart depicting a method 1900 for performing actions during a positioning operation on the material of system 10.

[0336] The material positioning process 1900 ensures that the robotic arm 105 is safely manipulated to the correct relative position above the biological tissue 12.

[0337] First, check 1901 is performed to determine whether the robotic arm 105 is within the surgical field of view, which includes a defined conical volume of space that originates at and extends vertically from the biological tissue 12, such that the sides of the cone are at 45°. If the robotic arm 105 is not within the surgical field of view, it is repositioned 1903 by raising the end effector 28 upward to its extension limit while moving the end effector 28 laterally toward the biological tissue 12 until it is within the surgical field of view positioned above the biological tissue material to be treated.

[0338] Once the robotic arm 105 is within the surgical field of view 1905, the robotic arm will begin to lower the end effector 28 to the correct position above the biological tissue 12 1907. Once the end effector is in the correct position, it will stop moving the robotic arm 105 1911.

[0339] If the robotic arm 105 encounters an obstacle at any stage (e.g., detected by an increase in torque on one or more joints of the manipulator 23, or by the operation of one or more pressure-sensitive pads on the outer side of a section of the manipulator 23), it will stop 1911 to prevent it from hitting the worker or other targets in the environment.

[0340] Figure 20 A flowchart depicting a method 2000 for performing actions during a standby positioning operation in system 10.

[0341] This ensures that the robotic arm 105 is safely manipulated away from the biological tissue 12 to the ready position.

[0342] If the robotic arm 105 is within the surgical field of view 2001, the end effector 28 is repositioned by raising the end effector upward toward the extension limit of the robotic arm 105 while moving the end effector laterally in the direction of the ready position. In this embodiment, the ready position is the position of the robotic arm 105 above the base unit 27, such that it cannot become an obstacle to or interfere with any reasonable actions to be performed in the surgical work area.

[0343] Once the robotic arm 105 is outside the surgical field of view above the standby position 2005, the end effector 28 lowers towards the standby position 2007 while continuing to move laterally in the same direction until it reaches it. It then stops 2011.

[0344] With Figure 19 The flowchart of method 2100, which performs the action described in method 1900, is in the same manner. If the robotic arm 105 encounters an obstacle at any stage, it will stop in 2011.

[0345] Figure 21 A flowchart depicting a method 2100 for actions performed during a prosthesis removal procedure in system 10.

[0346] Procedure 2100 retrieves the next prosthesis component to be removed from plan 1502 (2101). The order of removal in the plan has been determined by the surgical procedure data, such as... Figure 17 As seen in the text.

[0347] The surgeon is given the opportunity 2103 to modify or alter the planned resection before the system 10 takes action. This may include, for example, adjusting the parameters of the resection or selecting a different resection to be performed next.

[0348] If surgeon 16 does not wish to change the resection procedure, system 10 can operate as shown in [reference]. Figure 22 The resection 2105 was performed in more detail.

[0349] If all cuts in the plan have not yet been executed, the process will retrieve 2101 for the next cut from the plan until all cuts have been executed.

[0350] Once all planned excisions have been performed, system 10 can be operated to perform prosthesis assembly fitting and alignment analysis 2107.

[0351] In this embodiment, this evaluation is performed by system 10 through prosthesis component fitting and alignment analysis, as will be seen in [reference]. Figure 26 To describe in more detail.

[0352] If the removal of all components does not meet the fit and alignment tolerances required for adequate positioning, system 10 is operable to modify the 2109 plan to perform a corrective removal step to correct the deviation between the ideal fit and alignment and the current geometric fit and alignment.

[0353] If the fit and alignment analysis of the prosthesis components is sufficient, the surgeon is given the opportunity to independently review the analysis and optionally modify the resection plan to achieve variations in fit and alignment. This may be important after testing the prosthesis and determining, for example, that joint flexion and extension do not provide proper clearance and adjustments to the resection or that a different size prosthesis component is required.

[0354] Figure 22 A flowchart depicting a method 2200 for actions performed during a resection operation of system 10. In an embodiment, the planned state of the biological tissue 12 after the at least one processing action has been performed includes the need for an ideal plane or mesh in the 3D space exposed on the biological tissue 12 via subtractive erosion. An ideal plane or mesh is provided for the resection process.

[0355] Process confirmation 2201: The robotic arm 105 is positioned correctly above the biological tissue 12. While the biological tissue 12 is not completely stationary, it is necessary to continuously check and readjust 2203 the absolute position of the end effector 28 as described herein to maintain the same relative position. The position of the biological tissue 12 is retrieved from the mapping component, which in turn retrieves the position of the reference marker 70 via the position sensor controller 171.

[0356] The "safe operating area" is a virtual zone from which the robotic arm 105 is not permitted to leave. If the robotic arm 105 attempts to reposition itself outside this safe operating area, the system 10 can be operated to be placed in a paused state until released by the user. This is an added safety mechanism to prevent the robotic arm 105 from making physical contact with, for example, surgical personnel.

[0357] At the correct relative position, system 10 is operable to scan the geometry of the target using 3D measurement sensor 190. Several sensors in sensor groups 101 and 102 then scan 2205 biological tissue 12 to determine its composition. These sensors include those for hyperspectral imaging, Raman spectroscopy, thermal imaging, microscopy, acoustic imaging, and optical imaging. The overall results of the scans are analyzed, combined, and stored by system 10, making them available for use by the mapping component.

[0358] The excised surface is transformed from 3D information 2207 into a 2D mapping to extract unnecessary data for surface configuration and composition in the analysis of the excised surface. The geometry is simplified into a 2D height map, in which the associated hyperspectral and thermal 2D maps are superimposed in the same coordinate space.

[0359] Process analysis 2209 uses a height map and mapping of the geometry to be removed to determine the current consistency of the surface with the tolerance required for an accurate removal. If the surface is intact within the tolerance, the removal is complete 2211.

[0360] Otherwise, system 10 can be operated to calculate the ablation process 2230 – a series of laser ablation processes that will reduce the surface by one layer of material.

[0361] System 10 is operable to perform an analysis of the degree to which the post-action state of biological tissue 12 aligns with the planned state of biological tissue 12, in order to determine the parameters of the required ablation process.

[0362] Specifically, in this embodiment, the process combines the mapping component results with 3D surface data, component data, and any thermal data retrieved from previous ablation to analyze the excised volume 2209 to determine the current consistency of the sensed geometry with a set of optimal parameters of the laser beam 30, in order to perform the ablation process 2230 to safely and effectively reduce the surface of the biological tissue 12 without burning or causing necrosis.

[0363] As part of the analysis, ( Figure 13 The system coordinator 200 is operable to generate and / or receive, as input, at least one third representation of the biological tissue 12. In an embodiment, the at least one third representation of the biological tissue 12 includes a representation (evaluation 2909) corresponding to the state of the biological tissue 12 after the at least one processing action has been performed on the biological tissue, or to its final state. The at least one third representation of the biological tissue 12 includes parameters that describe or provide indications of one or more characteristics of the biological tissue 12, and in an embodiment includes a map or model of the post-action state of the biological tissue 12.

[0364] System 10 is operable to initialize the starting coordinates 2215 on the target biological tissue 12 for initiating the erosion process.

[0365] During the ablation process, system 10 is operable to adjust laser parameters such as current and pulse duration parameters 2213 to pre-calculated values ​​for each target coordinate in real time.

[0366] The process calculates the position of the 2D map target coordinates in 3D space.

[0367] A precision motion component (in a preferred embodiment, the scanning head 117) is operable to reorient the laser beam 30 to a target on the surface of the biological tissue 12. In this embodiment, each firing sequence of the laser beam 30 needs to be aimed at a point on the biological tissue 12 with micrometer-level precision.

[0368] System 10 is operable to check to ensure, in the embodiment, that the surgeon 16 has not stopped system 10 before each shot of laser beam 30.

[0369] The laser current source 131 is guided to fire the laser beam 30 using the current parameter settings.

[0370] If the erosion process is not yet complete, select the next coordinate in the map 2217, adjust the laser parameters 2213, and system 10 repeats the repositioning 2219 and firing 2221 of laser beam 30.

[0371] Once the ablation process is complete, the surface 2223 is sensed by thermal sensor 184 to check for thermal shock. The thermal data 2225 generated by such sensing can then be used by the laser optimization components for future ablation processes.

[0372] The location of biological tissue 12 is examined to locate the end effector 28, and the mapping, analysis, and ablation processes are repeated.

[0373] Regarding robot movement, system 10 is operable to position the sensors, laser optics, and assistive tools in end effector 28 above and at a predetermined relative distance from biological tissue 12.

[0374] Positioning depends on the joint angle of the robotic arm 105. The calculation of the joint angle for the final position and all intermediate positions involves inverse kinematics.

[0375] Preferably, system 10 will rely on and use the inverse kinematics infrastructure provided in the robotic arm 105 to determine the joint angle and movement required to move the end effector 28 from one Cartesian point to another. This will make the robot motion components a facade for the aforementioned functionality.

[0376] If the robot arm controller 106 does not provide the required functionality, it will be necessary to use an existing or custom library that supports inverse kinematics calculations.

[0377] Figure 23 A flowchart depicting a method 2300 for describing the actions performed during 3D-to-2D projection of a cut surface.

[0378] While resection is being performed, system 10 is operable to maintain awareness of the sensed geometry: it is suitable for the reduction process that shrinks biological tissue 12 to the desired geometry.

[0379] The mapping component maintains the mesh and other auxiliary data describing the geometry and components of the biological tissue 12. The projection process uses this information to generate a specialized data source for guided resection parameters.

[0380] The process is operable to retrieve 2301 geometry and component data from the mapping component.

[0381] When the resection surface is planar, the mapping geometry is rotated 2303 around the center of the femoral superior malleolus axis so that the coordinates of the resection plane are aligned with the zero axis of the X and Y coordinates (where Z is up / down).

[0382] Calculate the intersection volume between the 2205 mapped geometry and the positive Z region above the X / Y plane. The skeletal portion of this volume is the segment that needs to be ablated in a subtractive manner. The remaining volume may be blocking material that needs to be preserved and should not be ablated, nor should it conform to the ray projection calculation between the laser beam origin and any target points to be ablated.

[0383] Because the bone volume X / Y plane is aligned to the excision plane, the Z value can be simply viewed as a grid at different heights above the desired flattened result. Height maps can be interpolated from the grid by applying a raster with the minimum resolution required to perform flattened planar erosion.

[0384] In cases where the resection surface is not planar, a 2307 geometric mesh is calculated in spherical coordinates from the center of the condyle (e.g., defined as a % or % position on the femoral epicondyle axis, depending on which condyle the resection surface is located on).

[0385] The angles φ and θ are sampled at sufficiently small degrees, such that the grid spacing is approximately 50 micrometers at the average distance from the surface. Essentially, this allows the sampled φ to become the x-axis on a 2D map, and the angle θ to become the y-axis. The ideal excised surface is considered to be at zero height, and any existing biological tissue above zero height is considered a positive height value. This newly created height map can then be analyzed and processed in the same way as if the excise had occurred in a plane.

[0386] The process can then be operated to determine the occlusion geometry 2309 by removing any geometry that does not exist within the intersection of the mapped geometry and the containing shape.

[0387] For the femoral head, the shapes include the following intersections:

[0388] (1) Two ellipses centered at the 1 / 4 and 3 / 4 positions of the femoral superior malleolus axis, having a width radius (along) the axis of the 1 / 4 femoral superior malleolus axis and a height radius of the femoral superior malleolus axis; and

[0389] (2) A solid cylinder with the long axis and height of the femoral superior malleolus axis and the radius of 3 / 4 of the femoral superior malleolus axis.

[0390] For the tibial plateau, the shape includes a solid cylinder, wherein the major axis is aligned with the radius of the cortical layer having a distance equal to the width of the plateau.

[0391] The process can then be operated to create a set of 2D maps 2311 in the same coordinate space for height, hyperspectral values, and calorific values. This reduced-dimensional data is used by various components of system 10 to analyze the excision process and determine laser optimization for ablation.

[0392] As part of the analysis, ( Figure 13 The system coordinator 200 is operable to compare a representation of the post-action state of the biological tissue 12 with a representation of the planned state of the biological tissue 12 to assess the degree to which the state of the biological tissue 12 after the at least one treatment action has been performed on the biological tissue aligns with the planned state of the biological tissue 12 (i.e., Figure 22 Mapping step 2205 and Figure 23 Method 2300), thereby assessing the degree to which the action has been successfully formed. The degree of alignment and coordination between the representation of the post-action state of the biological tissue 12 and the representation of the planned state of the biological tissue 12 provides a measure of success within specified tolerances. This process can be summarized as determining how the sensed reality should be represented internally in a useful manner for processing and identifying the laser ablation object. Figure 23 As can be seen, there are four (4) representations 2311 further used by the planning 2313 and laser optimization 2315 processes: “2D height map of the excised surface” 2311a, “2D hyperspectral map of the excised surface” 2311b, “2D thermal map of the excised surface” 2311c, and “2D acoustic map of the excised surface” 2311d.

[0393] Figure 24 A flowchart depicts a method 2400 that performs the reverse action of a 3D-to-2D projection to reduce the dimensionality of the data. System 10 requires the 3D position of each target coordinate on a 2D map to locate the laser beam 30 to ablate the correct biological tissue 12.

[0394] The process is operable to retrieve the 2401 X / Y target coordinates from the erosion process and height map data in the 2D map. It also retrieves 2403 local geometry data from the mapping component.

[0395] If the surface to be removed is planar, the X / Y target coordinates are rotated 2405 from horizontal alignment back to alignment with the removal plane. The 3D target coordinates can then be determined at a height distance orthogonal to the now rotated plane.

[0396] If the excised surface is not planar, the process can be operated to transform the X / Y coordinates 2409 to condylar-centered angular spherical coordinates of φ and θ. The 3D target coordinates 2411 can then be determined at the height distance 2411 at angles φ and θ along a ray from the condylar center.

[0397] The resulting 3D coordinates are made usable (2413), so that system 10 can subsequently aim at biological tissue 12 at the correct position in the world coordinate system.

[0398] Figure 25 A flowchart depicting the method 2500 for the actions performed during the surface resection analysis operation in system 10.

[0399] System 10 is operable to calculate the distance between two tolerance planes for all geometries of the 2501 enclosing surface. This provides a quantification of the overall flatness of the geometry.

[0400] System 10 is also operable to calculate the slope of geometry 2503 by adapting the plane to the vertices. This slope information is important for the overall alignment of the prosthesis assembly.

[0401] System 10 is operable to subsequently quantify the specific deviations and consistency of the 2505 surface geometry compared to the ideal geometry planned for the surface. This includes a basic profile, roughness profile, fluctuation profile, and shape profile determined using standard methods of surface property analysis.

[0402] As part of the analysis, the system coordinator 200 is operable to generate and / or receive as input at least one second representation of the biological tissue 12. In an embodiment, the at least one second representation of the biological tissue 12 includes a representation of the state of the biological tissue 12 corresponding to a planned or predetermined state of the biological tissue 12 after the at least one processing action is performed on the biological tissue. The at least one second representation of the biological tissue 12 includes parameters describing or providing indications of one or more characteristics of the biological tissue 12, and in an embodiment includes a map or model of the planned state of the biological tissue 12.

[0403] The resulting analysis dataset is provided to the planning system for prosthesis component fit and alignment analysis.

[0404] Figure 26 A flowchart depicting a method 2600 for actions performed during prosthetic component fitting and alignment analysis operations in system 10.

[0405] The loaded plan retrieves the prosthesis component geometry 2601 for processing against the retrieved mapped geometry. System 10 is operable to simulate the prosthesis component 2603 onto the mapped geometry using the finite element method to detect / calculate 2605 the stresses and deformations that may affect the fit and subsequent alignment of the component with the mechanical axis of the patient 14.

[0406] The quantified consistency, fit, and alignment data of 2607 are made available to system 10 for automation and for surgeon 16 to make decisions regarding the resection being performed. The results are also presented to surgeon 16 via display 20.

[0407] Figure 27 A flowchart depicts a method 2700 for actions performed during a bioanalysis operation of system 10, wherein sensor information is analyzed to obtain component characteristics of biological tissue 12. This helps prevent system 10 from targeting soft tissue or otherwise causing collateral damage to portions of patient 14 that should not be removed.

[0408] The mapping component 2701 has aligned all sensor data 2703 onto the geometric surface to take into account the different viewpoints from which the sensors are placed in the biological tissue 12.

[0409] In an embodiment of the invention, the data may be preprocessed 2705 to remove noise and artifacts from the sensed information that would obscure feature detection.

[0410] System 10 is operable to perform feature extraction 2707 on data by comparing the data signal with a known signature already determined from previous tests. This can be done across the various measuring sensors of the sensor groups 101 and 102 for the same target location to predict the composition at each point.

[0411] System 10 is operable to subsequently apply the bioanalysis prediction 2709 back to the mapping component to provide additional metadata for use by parts of System 10 to guide decisions and actions.

[0412] Figure 28 A flowchart depicting a method 2800 for performing actions during acoustic sound analysis operations in system 10.

[0413] The bioanalysis component also uses an acoustic sensor 178 to determine whether erosion has been performed on hard biological tissue.

[0414] The acoustic profile produced by laser ablation of bone differs from that produced by other materials. System 16 is operable to utilize this to increase overall safety during the ablation process. Method 2800 includes the steps of: receiving 2861 acoustic data 177 picked up by acoustic sensor 178 at the treatment site from the environment and surrounding biological tissue 12; and analyzing 2803 the acoustic data to determine whether the received acoustic data when the laser strikes the bone material matches the expected sound. When an unexpected sound is received and analyzed, system 10 is operable to stop 2805 ablation. Due to the speed of the laser pulse, this does not prevent several faster laser bursts from striking non-bone surfaces before the processing of the previous acoustic profile is complete, but it prevents further damage.

[0415] System 10 is operable to detect whether the laser beam 30 has just been fired and accesses acoustic data from acoustic sensor 178, including sound waves. The sound waves are analyzed to detect whether they match the profile of the hard biological tissue being eroded by means of different frequencies and amplitudes.

[0416] If the voices do not match, a message is sent to system 10 to stop the operation.

[0417] Figure 29 A flowchart depicting a method 2900 for actions performed during laser optimization operation of system 10. The purpose of this component is to perform risk-sensitive decisions for autonomous control of laser parameters in a minimally observable environment.

[0418] The ablation laser is controlled via several dependent parameters that influence how it interacts with different materials. Laser-based machining is a complex task because it involves tuning these parameters to suit the material being ablated. This material varies between patients, depending on the type of bone and its components (minerals, collagen, and water content), as well as factors such as sex, age, and ethnicity. Laser optimization determines the optimal set of parameters for the laser beam 30 to safely ablate hard tissue. Furthermore, the system 10 is operable to quantify its confidence level at each stage of the decision-making process and is capable of outputting human-understandable diagnostic information.

[0419] The laser optimization component retrieves 2901 data points from the excised surface analysis component. This data has been preprocessed into a series of 2D maps: height, hyperspectral, bioanalytical, thermal, and acoustic. The 2D maps are oriented excised planes, or maps derived from the spherical coordinates of the excised surface.

[0420] Based on this data foundation, the component can classify the data 2903 into known material types. As a low-level function, it generates 2905 a set of candidate laser parameters predicted to produce the desired result. These candidate laser parameters are tested in the model to determine 2907 which candidates are the most likely to produce the desired result.

[0421] The applicability of those consequences is then evaluated. In some cases, undesirable results may be predicted, so the component may choose to relax some of the restrictions on parameter selection in 2911 before generating a new set of parameters for testing in 2905.

[0422] When a component has exceeded the time frame of an experimental alternative, object 2913 can be modified to facilitate parameter selection that enables partial solutions rather than no solutions.

[0423] If a component runs out of time for alternative parameters and no solution has been reached, system 10 is stopped (2915).

[0424] The security, monitoring, and verification operations of System 10 include:

[0425] • Correct cutting position;

[0426] • Expected organization type; and

[0427] • Expected effects (heat, stress, material removal).

[0428] The consequences and results of operations that may originate from System 10 include:

[0429] • Efficiency, including cutting / shaping speed;

[0430] • Geometric effects, including aspects of cutting physical properties; and

[0431] Side effects, including thermal shock:

[0432] Methods 1400 to 2900 (and Figures 14 to 29 The associated methods described in the text can be used, for example... Figure 30 The computing device / computer system 3000 shown in the figure is implemented, wherein Figures 14 to 29 The process can be implemented as software, such as one or more application programs executable within a computing device 3000. Specifically, the steps of the methods disclosed herein are implemented by instructions in software implemented within a computer system 3000. These instructions can be formed as one or more code modules, each code module for performing one or more specific tasks. The software can also be divided into two separate parts, wherein a first part and its corresponding code modules execute the described methods, and a second part and its corresponding code modules manage the user interface between the first part and the user. The software can be stored in a computer-readable medium, such as a storage device comprising the storage described below. The software is loaded from the computer-readable medium into the computer system 3000 and then executed by the computer system 3000. A computer-readable medium having such software or a computer program recorded thereon is a computer program product. The use of the computer program product in the computer system 3000 preferably enables an advantageous apparatus for laser shaping of biological tissues containing bone.

[0433] refer to Figure 30 An exemplary computing device 3000 is shown. The example computing device 3000 may include (but is not limited to) one or more central processing units (CPUs) 3001 including one or more processors 3002, system memory 3003, and a system bus 3004 connecting various system components, including the system memory 3003, to the processing unit 3001. The system bus 3004 may be any of several types of bus architectures, including a memory bus or memory controller using any of a variety of bus architectures, a peripheral bus, and a local bus.

[0434] The computing device 3000 also typically includes a computer-readable medium, which may include any usable medium accessible by the computing device 3000 and includes both volatile and non-volatile media, as well as removable and non-removable media. By way of example and not limitation, a computer-readable medium may include computer storage media and communication media. A computer storage medium includes media implemented in any way or by any technique for storing information such as computer-readable instructions, data structures, program modules, or other data. A computer storage medium includes (but is not limited to) RAM, ROM, EEPROM, flash memory or other memory technologies, CD-ROM, digital versatile optical disc (DVD) or other optical disc storage devices, magnetic tape, magnetic tape, disk storage devices or other magnetic storage devices, or any other medium that can be used to store desired information and is accessible by the computing device 3000. A communication medium typically embodies computer-readable instructions, data structures, program modules, or other data in the form of modulated data signals such as a carrier wave or other transmission mechanisms, and includes any information delivery medium. By way of example and not limitation, communication media include wired media, such as wired networks or direct wired connections; and wireless media, such as acoustic, RF, infrared, and other wireless media. Any combination of the above should also be included within the scope of computer-readable media.

[0435] System memory 3003 includes computer storage media in the form of volatile and / or non-volatile memory, such as read-only memory (ROM) 3005 and random access memory (RAM) 3006. A basic input / output system 3007 (BIOS), containing basic routines that facilitate the transfer of information between components within computing device 3000 (e.g., during startup), is typically stored in ROM 3005. RAM 3006 typically contains data and / or program modules that can be immediately accessed by processing unit 3001 and / or currently operated by processing unit 3001. By way of example and not limitation, Figure 30 The diagram shows the operating system 3008, other program modules 3009, and program data 3010.

[0436] The computing device 3000 may also include other removable / non-removable, volatile / non-volatile computer storage media. (This is just one example.) Figure 30 This illustrates a hard disk drive 3011 that reads from or writes to a non-removable, non-volatile magnetic medium. Other removable / non-removable, volatile / non-volatile computer storage media that can be used with an instance computing device include (but are not limited to) magnetic tape, flash memory cards, digital universal optical discs, digital video tapes, solid-state RAM, solid-state ROM, etc. Hard disk drive 3011 is typically connected to system bus 3004 via a non-removable memory interface such as interface 3012. The above discussion and Figure 30The drive and its associated computer storage medium shown provide storage for computer-readable instructions, data structures, program modules, and other data of the computing device 3000. Figure 30 For example, hard disk drive 3011 is shown storing operating system 3013, other program modules 3014, and program data 3015. It should be noted that these components may be the same as or different from operating system 3008, other program modules 3009, and program data 3010. Operating system 3013, other program modules 3014, and program data 3015 are given different numbers here to indicate, at a minimum, that they are different copies.

[0437] The computing device also includes one or more input / output (I / O) interfaces 3030 connected to the system bus 3004, including an audio-video interface coupled to an output device including one or more of a video display 3034 and a speaker 3035. The input / output interface 3030 is also coupled to one or more input devices, including, for example, a mouse 3031, a keyboard 3032, or a touch-sensitive device 3033 (e.g., a smartphone or tablet computer device).

[0438] As described below, the computing device 3000 can operate in a networked environment using a logical connection to one or more remote computers. For simplicity of explanation, the computing device 3000... Figure 30 The diagram shows a connection to network 3020, which is not limited to any particular network or networking protocol, but may include, for example, Ethernet, Bluetooth, or IEEE 802.X wireless protocols. Figure 30 The logical connection depicted is a general network connection 3021, which can be a local area network (LAN), a wide area network (WAN), or other network (e.g., the Internet). The computing device 3000 is connected to the general network connection 3021 via a network interface or adapter 3022, which in turn is connected to the system bus 3004. In a networked environment, program modules depicted relative to the computing device 3000 or parts thereof or peripheral devices may be stored in the memory of one or more other computing devices, which are communicatively coupled to the computing device 3000 via the general network connection 3021. It should be understood that the network connection shown is merely an example, and other means of establishing communication links between computing devices may be used.

[0439] In embodiments of the invention, one or more of the described additional and / or alternative operations performed by system 10 occur semi-automatically or automatically without human intervention.

[0440] It is understood that, in the described implementation, the laser is coupled to the robot and this pair is integrated with optical and mechanical sensors to provide a closed loop for the skeletal system (machine) to reduce laser-assisted machining, thereby taking into account computationally derived process parameters for the design and selection of operating parameters during real orthopedic surgery in a clinical setting (in order to obtain rapid and accurate results).

[0441] It should be understood that the embodiments described in this invention offer several advantages.

[0442] Embodiments of System 10 are capable of machining hard biological tissues with sub-millimeter precision and include the following features: non-invasive real-time optical sensing; intelligent and dynamic control of laser parameters; and bioverification after machining.

[0443] Embodiments of the present invention include: using non-invasive optical sensing to ensure precise control, safety, and positioning of lasers; developing and teaching artificial intelligence systems to control the laser shaping process in real time; optimizing laser parameter verification against cellular and molecular assessments; and optimizing the performance of integrated systems.

[0444] Embodiments of the present invention may allow for surgeries with the following improvements: improved cutting accuracy, improved sub-millimeter precision of cutting, new safety improvements attributable to monitoring capabilities, avoidance of collateral damage, and improved bio-quality of the cutting surface by optimizing laser parameters through the use of analysis and machine learning techniques.

[0445] It is anticipated that, in the First World alone, more than 2 million patients will benefit annually from the technology of embodiments of the present invention.

[0446] Embodiments of the present invention provide high accuracy and sub-millimeter precision through intelligent adaptive shaping, low thermal and biomechanical effects, vibration-free shaping, and multiple redundancy safety features.

[0447] Embodiments of the present invention provide real-time optimized patient-specific laser ablation. The system of the embodiments receives continuous feedback from sensors, as well as model and post-ablation assessments (the biological state of residual tissue), and adjusts laser parameters to their optimal levels. This results in maximum or improved tissue removal, and absolutely minimal or reduced thermal shock.

[0448] Through system implementation, laser ablation can be provided in a manner that is customized for each patient; has zero / minimum / reduced thermal shock (biomass); is geometrically precise; has real-time adjustable parameters; and has multiple levels of safety (including guide laser, sensors, post-cutting sensing, and surgeon control).

[0449] The sub-millimeter precision, low mechanical and thermal shock provided by embodiments of the present invention can advantageously revolutionize implant manufacturing and also achieve significant improvements in patient outcomes and quality of life.

[0450] Embodiments of the present invention enable minimal orthopedic surgery with the following features: minimal human intervention, semi-automatic or fully automatic, high precision, rapid surgery, minimal invasive tissue damage, reduced or no blood transfusion, improved implant integration, and reduced cost.

[0451] Embodiments of the present invention advantageously use lasers to ablate biological tissue, performing the procedure quickly, safely, accurately, and cleanly within the same time constraints as surgery.

[0452] To rapidly ablate hard biological tissue within the same surgical time constraints, the described embodiments take into account both safety and accuracy, increasing or maximizing the volume of removable material. It enables rapid ablation of material in any situation where the hard biological material surrounding the target location would be damaged and would later need to be removed. It binds the liquid applied to the tissue during the ablation procedure for cooling the tissue with a cold coolant from the base unit to the end effector for cooling the liquid. Laser optimization is based on the dynamics of interaction with the hard biological tissue to increase or maximize the rate of machining. It performs ablation in "processes," which consist of a series of laser ablations in the form of rapid bursts between sensing actions. This operation provides an optimal balance between sensing (guarantee) and speed.

[0453] To safely ablate hard biological tissue, the described embodiments prevent damage (necrosis / thermal shock / cracking) to the surface of the ultimately removed tissue. This is achieved by using low laser power to ensure no damage to the final surface or minimizing damage to the final surface, and by introducing cold water into the material using a water jet to assist laser ablation and prevent thermal damage to the material. This is further achieved by protecting personnel with consumable shielding that helps prevent accidental injury or damage from contact with the laser beam.

[0454] To accurately ablate hard biological tissue, the described embodiment uses a robotic arm to position an end effector above the target, followed by a scanning head to guide the laser with greater accuracy. Furthermore, it uses 3D measurement sensors to map the geometry of the material. In this respect, it reduces the dimensionality of the 3D geometry to a series of 2D maps based on a planar or spherical coordinate system, thus providing surgeons16 a faster and more easily understood display. All other sensor information can be overlaid on the same 2D map. Analysis of the excision surface allows for optimal patient fit and alignment. It uses hyperspectral sensors to distinguish tissue types. It uses acoustic sensors to detect whether the laser has struck an unintended target. It uses laser-treated reference marks on the material to allow for extremely accurate tracking (far exceeding tracking with position sensors). It uses feedback from sensor data to improve the laser machining process and has a master system coordinator that allows for simulation, testing, and data entry (big data), thus providing intelligent control over the ablation process.

[0455] To cleanly ablate hard biological tissue, the described embodiment incorporates a particle collector, acting as a vacuum bag, into a consumable shield. Furthermore, it utilizes a series of traps and filters to store particulate matter, thereby preventing the final HERA filter from quickly becoming clogged with large particles.

[0456] Those skilled in the art will understand that variations and modifications to the invention described herein will be apparent without departing from the spirit and scope of the invention. It is believed that obvious variations and modifications will fall within the broad scope and limits of the invention as set forth herein.

[0457] Furthermore, future patent applications may be filed in Australia or overseas based on or claiming priority to this application. It should be understood that the appended provisional claims are provided by way of example only and are not intended to limit the scope of any such claims that may be made in future applications. Features may be added to or omitted from the provisional claims at a later date to further define or redefine the invention.

Claims

1. A laser osteotomy system for reshaping hard biological tissue containing bone, the system comprising: The tool includes a laser operable to perform at least one processing action, including laser ablation; A positioning member for positioning the tool relative to the hard biological tissue to perform the at least one treatment action; An input component, the input component including an optical sensor operable to measure light interacting with the sclerobiosis and the environment surrounding the sclerobiosis; as well as Controller, the controller: Input is received via the input component, the input including, but not limited to, the light measured by the optical sensor. The input is processed to map and identify the sclerothelial tissue and the environment surrounding the sclerothelial tissue. The mapping process includes analyzing the light to determine the configuration of the hard biological tissue and its surrounding environment, as well as the proximity of the hard biological tissue to the tool. The identification process includes analyzing the association between reflected light and one or more spectral markers of biological tissues, and Based on the processing of the input, the positioning component and the tool are controlled to process the hard biological tissue; and The system described therein is suitable for performing modeling and corrections.

2. The system of claim 1, wherein the processing of the received input by the controller under the control of electronic program instructions comprises: The received input is analyzed and decisions are made based on the analysis and criteria related to the at least one processing action to control the positioning member and the tool to process the hard biological tissue; The criteria mentioned therein include at least one of the following: the speed of the at least one processing action; the accuracy of the at least one processing action; the safety of the at least one processing action; and the cleanliness of the at least one processing action.

3. The system of claim 2, wherein, as at least part of the analysis, the controller operates to: The first representation of the sclerobial tissue is generated based on the input, or the first representation of the sclerobial tissue is received as input. A second representation of the sclerobial tissue is generated, the second representation including the planned state of the sclerobial tissue after the at least one processing action; as well as An evaluation is made based on the first representation and the second representation of the sclerobial tissue, and the evaluation is used to make a decision.

4. The system of claim 1, wherein the input component comprises at least one sensor system, the sensor system comprising a sensor group, wherein individual sensors within the sensor group are operable to monitor, sense, collect, or measure sensor data and / or information associated with or related to one or more characteristics, properties, and / or parameters of one or more of the laser osteotomy system, the hard biological tissue, the surrounding environment, components, systems, or devices associated with or connected thereto, systems, or devices. The sensors in the sensor group include sensors based on one or more of the following: optical imaging, thermal imaging, acoustic, measurement, and laser power.

5. The system of claim 1, wherein the input component comprises at least one sensor system, the sensor system comprising a sensor group, wherein individual sensors within the sensor group are operable to monitor, sense, collect, or measure sensor data and / or information associated with or related to one or more characteristics, properties, and / or parameters of one or more of the laser osteotomy system, the hard biological tissue, the surrounding environment, components, systems, or devices associated with or connected thereto, systems, or devices. The sensors in the sensor group include those based on one or more of the following: Raman spectroscopy, hyperspectral imaging, fluorescence spectroscopy, microscopy, and optical coherence tomography.

6. The system of claim 1, wherein the input component comprises at least one sensor system, the sensor system comprising a sensor group, wherein individual sensors within the sensor group are operable to monitor, sense, collect, or measure sensor data and / or information associated with or related to one or more characteristics, properties, and / or parameters of one or more of the laser osteotomy system, the hard biological tissue, the surrounding environment, components, systems, or devices associated with or connected thereto, systems, or devices. The sensors in the sensor group include sensors based on non-invasive sensing.

7. The system of claim 1, wherein the operations performed by the system occur semi-automatically under the control of the surgeon, or occur automatically without human intervention.

8. The system of claim 1, wherein processing of the input includes optimizing the operation of the laser to increase the ablation rate based on the dynamics of the interaction between the radiation beam generated by the laser and the hard biological tissue. in, The optimization includes taking into account criteria that include at least one of safety and accuracy in an attempt to increase or maximize the volume of eroded hard biological tissue. The control includes operating the laser at a lower power after the ablation has been performed on the hard biological tissue to reduce or mitigate damage to the surface of the hard biological tissue.

9. The system of claim 1, wherein the radiation beam is generated by the laser in the form of pulses, and the laser pulses are batched into an ablation process comprising a set of pre-calculated pulses spanning different locations across the hard biological tissue.

10. The system of claim 1, wherein the tool includes the laser, the laser including a jetting device for jetting liquid onto the hard biological tissue to assist laser ablation and at least to some extent prevent thermal damage to the hard biological tissue.

11. The system of claim 1, wherein the system includes a cooling component for cooling one or more components of the system and the liquid.

12. The system of claim 1, comprising a shield for providing protection during the treatment of the sclerothelial tissue, wherein one or more components are shielded to provide one or more of the following: providing personal protection; filtering and / or capturing and storing particulate matter; and protecting the system from contamination by encapsulation.

13. The system of claim 1, wherein the positioning member comprises a robotic arm, and the processing portion of the tool is provided on the end effector of the robotic arm.

14. The system of claim 1, wherein the positioning member includes a fine motion controller adapted to accurately guide the processing portion of the tool.

15. The system of claim 1, wherein when the input includes input from a 3D measurement sensor, processing the input includes using the input to map the geometry of the hard biological tissue and its surrounding environment.

16. The system of claim 1, wherein processing of the input includes using the input to infer the type and components of a biological tissue.

17. The system of claim 1, wherein when the input includes input from an acoustic sensor, processing the input includes using the input from the acoustic sensor to detect whether the tool has processed non-determined or unintended biological tissue or material.

18. The system of claim 1, wherein the laser is adapted to form one or more reference marks on the hard biological tissue for tracking the hard biological tissue.

19. The system of claim 1, wherein the controller includes artificial intelligence (AI) software incorporating machine perception or machine learning.

20. The system of claim 1, wherein the tool includes a dynamic focusing optics operable to dynamically change the focal length and focus the beam diameter of the laser beam at a target distance.

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