Drilling apparatus, system and method

Abstract

Apparatuses, systems, and methods for drilling anatomical elements are provided. A drill bit can include a coaxial hollow shaft in communication with a plurality of orifices disposed on a surface of the drill bit. A fluid inlet can be in fluid communication with the coaxial hollow shaft via a selectively openable valve. The fluid inlet can be configured to receive pressurized fluid. When the valve is open, the pressurized fluid can be released into the coaxial hollow shaft, and when at least one of the plurality of orifices is unobstructed, the pressurized fluid can be released through the at least one of the plurality of orifices.

Description

Technical Field

[0001] This technology relates generally to drilling apparatus, and more specifically to drill bits for drilling anatomical elements. Background Technology

[0002] Surgical robots can assist surgeons or other healthcare providers in performing surgical procedures, or they can perform one or more surgical procedures autonomously. During such procedures, surgical tools can be used on one or more anatomical elements. These tools can be oriented and operated by the surgical robot and / or the surgeon or other healthcare provider. Summary of the Invention

[0003] Exemplary aspects of this disclosure include: An apparatus for drilling anatomical elements according to at least one embodiment of the present disclosure includes: a drill bit including a coaxial hollow shaft in communication with a plurality of orifices disposed on a surface of the drill bit, one of the orifices being disposed at a tip of the drill bit and one or more of the orifices being angled to the axis of the coaxial hollow shaft; a fluid inlet in fluid communication with the coaxial hollow shaft via a selectively openable valve, the fluid inlet being configured to receive pressurized fluid; and wherein when the valve is open, the pressurized fluid is released into the coaxial hollow shaft, and the pressurized fluid is released through the at least one of the plurality of orifices when the at least one of the plurality of orifices is not blocked.

[0004] In any aspect of this document, the device further includes: at least one processor; and a memory storing instructions for execution by the at least one processor, which, when executed, cause the at least one processor to: rotate and advance the drill bit, open the valve, and monitor the pressure of the fluid via a pressure sensor in fluid communication with the coaxial hollow shaft.

[0005] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: receive sensor data from the pressure sensor; and compare the sensor data with a predetermined threshold.

[0006] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to advance the drill bit when the pressure of the fluid is above the predetermined threshold.

[0007] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further instruct the at least one processor to open the valve once the drill bit has been activated for a predetermined time period, the drill bit has reached a predetermined drilling depth, or a predetermined drilling time has elapsed.

[0008] In any aspect of this document, the device further includes: at least one processor; and a memory storing instructions for execution by the at least one processor, which, when executed, cause the at least one processor to: rotate and advance the drill bit, open the valve, and monitor the flow rate of the fluid via a flow sensor in fluid communication with the coaxial hollow shaft.

[0009] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: receive sensor data from the flow sensor; and compare the sensor data with a predetermined threshold.

[0010] An apparatus for drilling anatomical elements according to at least one embodiment of the present disclosure includes: a drill bit including a coaxial hollow shaft communicating with a plurality of orifices disposed on a surface of the drill bit, one of the plurality of orifices being disposed at a tip of the drill bit; at least one processor; and a memory storing instructions for execution by the at least one processor, the instructions, when executed, causing the at least one processor to: rotate the drill bit; open a valve to release pressurized fluid into the coaxial hollow shaft; and monitor the pressure of the fluid to detect the release of the pressurized fluid through one or more of the plurality of orifices.

[0011] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to: receive sensor data from a sensor configured to measure the pressure of the fluid; and identify a decrease in the pressure of the fluid based on the sensor data.

[0012] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to advance the drill bit until the decrease in the pressure of the fluid is detected.

[0013] In any aspect of this document, the memory stores additional instructions for execution by the at least one processor, which, when executed, further cause the at least one processor to stop the drill bit when it detects a drop in the pressure of the fluid.

[0014] Any aspect of this article, wherein the plurality of orifices have a non-circular cross-section.

[0015] A system for drilling an anatomical element according to at least one embodiment of the present disclosure includes: a drill bit configured to drill an anatomical element, the drill bit including a coaxial hollow shaft in communication with at least one orifice disposed on a surface of the drill bit; a fluid system in fluid communication with the coaxial hollow shaft, the fluid system being configured to pressurize a fluid and distribute the pressurized fluid into the coaxial hollow shaft; a motor operatively connected to the drill bit; a user interface for selectively operating the motor; at least one processor; and a memory storing instructions for execution by the at least one processor, the instructions, when executed, causing the at least one processor to: cause the motor to rotate the drill bit, cause the fluid system to pressurize the fluid and distribute the pressurized fluid into the coaxial hollow shaft, and monitor the pressure of the fluid to detect the release of the pressurized fluid through the at least one orifice.

[0016] Any aspect of this article, wherein the at least one orifice is coaxial with the hollow shaft.

[0017] In any aspect of this document, the at least one orifice is a plurality of orifices, and one or more of the plurality of orifices are not coaxial with the hollow shaft.

[0018] Any aspect of this article, wherein the fluid is at least one of water or salt water.

[0019] In any aspect of this article, the system also includes a robotic arm configured to orient the drill bit.

[0020] In any aspect of this document, the fluid system is configured to distribute pressurized fluid into the coaxial hollow shaft after a predetermined time period following drill bit activation, at a predetermined drilling depth, or after a predetermined drilling time.

[0021] In any aspect of this document, the system further includes: a pressure sensor configured to monitor the pressure of the fluid, and wherein the motor is configured to stop when the pressure sensor detects a pressure drop.

[0022] In any aspect of this document, when the pressure sensor detects the pressure drop, a warning is generated and communicated via the user interface.

[0023] Any aspect combined with one or more other aspects.

[0024] Any one or more of the features disclosed in this article.

[0025] This article generally discloses one or more of the features.

[0026] Any one or more of the features generally disclosed in this article are combined with any one or more other features generally disclosed in this article.

[0027] Any one of the aspects / features / implementations may be combined with any one or more other aspects / features / implementations.

[0028] Use any one or more of the aspects or features disclosed herein.

[0029] It should be understood that any feature described herein may be combined with any other feature described herein to claim protection, regardless of whether the feature comes from the same described implementation.

[0030] Details of one or more aspects of this disclosure are set forth in the following drawings and description. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the specification and drawings.

[0031] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that possess both connective and disjoint qualities in operation. For example, the expressions “at least one of A, B, and C,” “at least one of A, B, or C,” “one or more of A, B, and C,” “one or more of A, B, or C,” and “A, B, and / or C” all mean only A, only B, only C, A and B together, A and C together, B and C together, or A, B, and C together. When each of A, B, and C in the above expressions refers to an element such as X, Y, and Z, or such as X1-X… n Y1-Y m and Z1-Z o When referring to a class of elements, the phrase is intended to mean a single element selected from X, Y, and Z; a combination of elements selected from the same class (e.g., X1 and X2); and elements selected from two or more classes (e.g., Y1 and Z). o () combination.

[0032] The term "a / an" refers to one or more of the same entity. Therefore, the terms "a / an," "one or more," and "at least one" are used interchangeably herein. It should also be noted that the terms "comprising / including" and "having" are used interchangeably.

[0033] The foregoing is a simplified overview of this disclosure to provide an understanding of some aspects thereof. This summary is neither a broad nor an exhaustive overview of this disclosure and its various aspects, embodiments, and configurations. It is not intended to identify key or essential elements of this disclosure, nor to define its scope, but rather to present selected concepts in a simplified form as an introduction to the more detailed description presented below. It should be understood that other aspects, embodiments, and configurations of this disclosure may utilize one or more of the features set forth above or described in detail below, individually or in combination.

[0034] Many additional features and advantages of the invention will become apparent to those skilled in the art upon consideration of the embodiments described below. Attached Figure Description

[0035] The accompanying drawings are incorporated in and form part of this specification to illustrate several examples of this disclosure. These drawings, together with the description, explain the principles of this disclosure. The drawings illustrate only preferred and alternative examples of how to implement and use this disclosure, and these examples should not be construed as limiting this disclosure solely to the examples shown and described. Further features and advantages will become apparent from the following more detailed description of various aspects, embodiments, and configurations of this disclosure, as illustrated by the accompanying drawings referenced below.

[0036] Figure 1 This is a schematic cross-sectional view of a drilling system according to at least one embodiment of the present disclosure; Figure 2 It is a block diagram of a system according to at least one embodiment of the present disclosure; Figure 3A This is a cross-sectional view of a drilling system according to at least one embodiment of the present disclosure; Figure 3B This is a cross-sectional view of a drilling system according to at least one embodiment of the present disclosure; Figure 3C This is a cross-sectional view of a drilling system according to at least one embodiment of the present disclosure; and Figure 4 It is a flowchart of at least one embodiment according to this disclosure. Detailed Implementation

[0037] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example or embodiment, certain actions or events of any process or method described herein may be performed in a different order, and / or may be added, combined, or omitted entirely (e.g., implementing the disclosed technology may not require all described actions or events depending on the different embodiments of this disclosure). Furthermore, although some aspects of this disclosure are described for clarity as being performed by a single module or unit, it should be understood that the technology of this disclosure can be performed by a combination of units or modules associated with, for example, computing devices and / or medical devices.

[0038] In one or more examples, the described methods, processes, and techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality may be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. A computer-readable medium may include a non-transitory computer-readable medium, which corresponds to a tangible medium, such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and is accessible by a computer).

[0039] The instructions can be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors (e.g., Intel Core i3, i5, i7, or i9 processors; Intel Celeron processors; Intel Xeon processors; Intel Pentium processors; AMD Ryzen processors; AMD Athlon processors; AMD Phenom processors; Apple A10 or 10X Fusion processors; Apple A11, A12, A12X, A12Z, or A13 Bionic processors; or any other general-purpose microprocessors), graphics processing units (e.g., Nvidia GeForce RTX 2000 series processors, Nvidia GeForce RTX 3000 series processors, AMD Radeon RX 5000 series processors, AMD Radeon RX 6000 series processors, or any other graphics processing units), application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Therefore, the term "processor" as used herein can refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, this technology can be fully implemented in one or more circuit or logic elements.

[0040] Before explaining any embodiment of this disclosure in detail, it should be understood that this disclosure is not limited in its application to the construction details and component arrangements set forth in the following description or shown in the accompanying drawings. This disclosure can have other embodiments and can be practiced or implemented in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “including / comprising” or “having” and variations thereof herein is intended to cover the items listed thereafter and their equivalents, as well as additional items. In addition, this disclosure may use examples to illustrate one or more aspects thereof. Unless otherwise expressly stated, the use or listing of one or more examples (which may be indicated by “for example,” “by means of an example,” “e.g.,” “such as,” or similar language) is not intended to, and does not limit, the scope of this disclosure.

[0041] During surgical procedures, drilling devices (such as drill bits) may be used to drill through bone (such as vertebrae). In some procedures (such as decompression procedures), there can be serious risks associated with the use of drill bits. For example, drill bits may be used to drill through hard tissue (such as bone, including vertebrae or the skull) adjacent to sensitive soft tissues that need protection (such as the dura mater, spinal cord, brain tissue, etc.). In some decompression procedures, such as drilling through a lamina foramen, preparation for laminectomy or laminatomy, as the drill penetrates the lamina and, if the drill penetrates much further than intended, it may penetrate the ligamentum flavum and / or the dura mater, potentially causing damage to the patient's spinal region.

[0042] At least one embodiment is provided as a potential solution to the risks to the dura mater and / or ligamentum flavum during initial drilling of the lamina. According to embodiments of this disclosure, two different measures are taken to prevent such injury: (1) sensing when the drill bit breaks through the lamina and enters the spinal canal, and (2) forming a protective barrier layer between the sharp drill tip and soft tissue. In some embodiments, a method is provided comprising drilling a hole in the lamina using a hollow drill bit configured such that water (or other fluids, such as, for example, viscous fluids) can pass through a central hole in the drill bit and exit near the tip of the drill bit (and / or allow water or other fluids to pass through other peripheral holes extending from the central hole to the outer edge of the drill bit and exit through the side surfaces of the drill bit). Water or other fluids are introduced into the hollow drill bit under pressure (e.g., a reasonable pressure that will not cause damage to body tissues) before breaking through the other side of the lamina. Bone and / or other hard anatomical tissues prevent fluid from escaping from the hollow drill bit until the drill bit breaks through the cortical bone near the dura mater, at which point water from the drill bit is discharged through one or more holes in the drill bit, splashing onto the outside of the lamina and pushing soft tissue away from the sharp edge of the drill bit. In addition, real-time measurements of fluid pressure and / or flow rate can be used as a sensing method to determine when to stop advancing the drill bit (e.g., based on measuring the time of a decrease in fluid pressure or an increase in flow rate (even if temporary).

[0043] The embodiments disclosed herein provide technical solutions to one or more of the following problems: (1) preventing damage to sensitive anatomical materials, (2) sensing when a drill bit breaks through an anatomical element, and (3) increasing patient safety during surgical procedures.

[0044] First go to Figure 1 A schematic diagram of a drilling system 100 and a cross-sectional view of a drill bit are shown. The drilling system 100 can be used to drill into any anatomical element and may be particularly useful where cutting or drilling may occur near any sensitive and / or soft tissue. In some embodiments, the drilling system 100 is used when cutting or drilling into hard tissue (such as bone) near soft tissue. The drilling system 100 advantageously protects sensitive soft tissue from damage when adjacent hard tissue is cut or drilled. The drilling system 100 includes a drill bit 102, a fluid system 104, a motor 106, and at least one sensor 132. Drilling systems according to other embodiments of this disclosure may include more or fewer components than the drilling system 100 (e.g., the system may also include a user interface 310, a processor 304, or a memory 306, each shown in Figure 3).

[0045] Drill bit 102 includes a shaft 108 extending from a first end 110 to a second end 112. Shaft 108 may be hollow and configured to receive fluid. In other words, shaft 108 may act as a fluid channel. In the illustrated embodiment, shaft 108 is coaxial with an axis 114 extending through the center of drill bit 102. In other embodiments, all or part of shaft 108 may not be coaxial with axis 114. For example, all or part of shaft 108 may be offset from axis 114. In the illustrated embodiment, shaft 108 is cylindrical in shape. In other embodiments, all or part of shaft 108 may not be cylindrical. For example, all or part of shaft 108 may be helical to increase the channel diameter without compromising the strength or drilling capability of drill bit 102. This increased channel diameter allows for lower pressure input to drill bit 102. Shaft 108 may have an opening 116 at the first end 110. In the illustrated embodiment, opening 116 is coaxial with axis 114. In other embodiments, opening 116 may not be coaxial with axis 114 and may be positioned at any angle to axis 114. In some embodiments, opening 116 is in fluid communication with fluid source 128 of fluid system 104. Opening 116 may be in fluid communication with fluid source 128 via a hose or pipe. In other embodiments, opening 116 is in fluid communication with fluid source 128 via fluid inlet 118 and valve 120. In the illustrated embodiment, fluid inlet 118 and valve 120 are coaxial with axis 114. In other embodiments, fluid inlet and / or valve 120 are not coaxial with axis 114. In such embodiments, fluid inlet and valve may each be positioned at any angle to axis 114.

[0046] The shaft 108 is also in fluid communication with at least one orifice 122 disposed on the surface 126 of the drill bit 102. In some embodiments, the at least one orifice 122 may have a circular cross-section. In other embodiments, the at least one orifice 122 may have a non-circular cross-section. In embodiments where the at least one orifice 122 comprises a plurality of orifices, each of the plurality of orifices may have the same cross-section, may have different cross-sections, or some of the plurality of orifices may have the same cross-section while others have different cross-sections.

[0047] Shaft 108 may be in fluid communication with one, two, or more orifices. In the illustrated embodiment, at least one orifice 122 includes a first orifice 122A, a second orifice 122B, and a third orifice 122C. The first orifice 122A may be coaxial with axis 114 and opens at a second end 112 to the tip 124 of drill bit 102. The second orifice 122B and the third orifice 122C may not be coaxial with axis 114. In other words, the second orifice 122B and the third orifice 122C may be angled relative to axis 114 and may be referred to as peripheral orifices.

[0048] During use, pressurized fluid moves from fluid source 128 to shaft 108 of drill bit 102. The fluid can be a gas (e.g., oxygen, air, carbon dioxide, a helium-oxygen mixture) or a liquid (e.g., water, brine, or another flushing agent). In embodiments including fluid inlet 118 and valve 120, fluid inlet 118 is configured to receive pressurized fluid, and when valve 120 is opened, pressurized fluid is released into shaft 108. Fluid may initially fill shaft 108 and / or any passage from shaft 108 to any peripheral orifice 122. As will be described more fully below, as drill bit 102 drills through anatomical elements (such as bone), at least one orifice 122 may be blocked by the anatomical element. As drill bit 102 begins to appear on one side of the anatomical element, one or more orifices may become unblocked by the anatomical element, and thus fluid can be released through one or more unblocked orifices. In other words, fluid is released through any one or more unblocked orifices 122.

[0049] The fluid can be pressurized and delivered by pump 130 of fluid system 104. Pump 130 can be any type of pump, including centrifugal pumps or positive displacement pumps. Pump 130 can also be submerged inside fluid source 128 or can be located outside fluid source 128. In some embodiments, pump 130 can be driven by a motor. In other embodiments, pump 130 can be a manual pump and can be operated manually.

[0050] System 100 may also include a motor 106 configured to rotate the drill bit 102. Motor 106 may be an electric motor, a pneumatic motor, a hydraulic motor, or another type of motor. In some embodiments, motor 106 includes a geared motor. In other embodiments, motor 106 includes any type of motor, including AC brushless motors, DC brushed motors, DC brushless motors, and servo motors. Motor 106 may include (or be operatively connected to) an electronic speed controller configured to control the rotational speed of the motor.

[0051] System 100 may also include at least one sensor 132 configured to monitor the pressure and / or flow rate of a fluid. Sensor 132 may be in fluid communication with shaft 108. In some embodiments, sensor 132 may be located on or within drill bit 102. In other embodiments, sensor 132 may be located on or within pump 130, fluid source 128, fluid inlet 118, or valve 120. In still other embodiments, sensor may be located regarding... Figure 2On any component of the drilling system 100 or system 200 described in detail. At least one sensor 132 may be any kind of sensor 132 for sensing fluid pressure and / or flow rate. Sensor 132 may include one or more of the following or any combination thereof: electrical components, mechanical components, electromechanical components, magnetic components, electromagnetic components, etc. Sensor 132 may include one or more of the following: flow sensor, barometer sensor, pressure gauge sensor, pressure transducer, strain gauge pressure transducer, capacitive pressure transducer, potentiometric pressure transducer, etc. In embodiments where sensor 132 includes at least a flow sensor, the flow sensor may be configured to measure the flow rate of fluid (e.g., entering drill bit 102, passing through drill bit 102) and may be configured to sense the time when drill bit 102 breaks through the dissecting element (e.g., by detecting the change in flow rate caused by fluid flowing out of drill bit 102). In some embodiments, sensor 132 may include a memory for storing sensor data. Still in other examples, sensor 132 may be directed to one or more sources (e.g., Figure 2 The computing device 202, processor 204 or memory 206 shown outputs signals (e.g., sensor data).

[0052] Go to Figure 2 The diagram illustrates a block diagram of a system 200 according to at least one embodiment of the present disclosure. System 200 can be used to monitor and control drilling of a anatomical element using a drill bit, and to detect when the drill bit breaks through one side of the anatomical element. System 200 can also be used to perform one or more other aspects of one or more methods disclosed herein.

[0053] System 200 includes the above-mentioned... Figure 1 The described components include a drilling system 100, a computing device 202, a robot 214, a navigation system 218, a database 230, and / or a cloud or other network 234. The drilling system 100 may be operated automatically or partially automatically by system 200 (e.g., with assistance and / or input from a surgeon or operator). Systems according to other embodiments of this disclosure may include more or fewer components than system 200. For example, system 200 may not include robot 214, navigation system 218, one or more components of computing device 202, database 230, and / or cloud 234.

[0054] The computing device 202 includes a processor 204, a memory 206, a communication interface 208, and a user interface 210. Other embodiments of the computing device according to this disclosure may include more or fewer components than the computing device 202.

[0055] The processor 204 of the computing device 202 may be any processor described herein or any similar processor. The processor 204 may be configured to execute instructions stored in the memory 206, which may cause the processor 204 to perform one or more computational steps using or based on data received from the robot 214, the navigation system 218, the database 230 and / or the cloud 234.

[0056] Memory 206 may be or include RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory used to store computer-readable data and / or instructions. Memory 206 may store information or data that can be used to perform any steps of, for example, the method 400 described herein or any other method. Memory 206 may store, for example, one or more surgical plans 220 and / or one or more instruction sets 222. In some embodiments, such instructions 222 may be organized into one or more applications, modules, packages, layers, or engines. Instructions 222 may cause processor 204 to manipulate data stored in memory 206 and / or received from or via drilling system 100, robot 214, database 230, and / or cloud 234.

[0057] The computing device 202 may also include a communication interface 208. The communication interface 208 can be used to receive data (such as sensor data) or other information from external sources (such as robot 214, navigation system 218, database 230, cloud 234, and / or any other system or component not part of system 200), and / or to transmit instructions or other information to external systems or devices (e.g., another computing device 202, robot 214, navigation system 218, database 230, cloud 234, and / or any other system or component not part of system 200). The communication interface 208 may include one or more wired interfaces (e.g., USB port, Ethernet port, FireWire port) and / or one or more wireless transceivers or interfaces (configured to transmit and / or receive information, for example, via one or more wireless communication protocols such as 802.11a / b / g / n, Bluetooth, NFC, ZigBee, etc.). In some implementations, the communication interface 208 can be used to enable the device 202 to communicate with one or more other processors 204 or computing devices 202, whether to reduce the time required to complete computationally intensive tasks or for any other reason.

[0058] The computing device 202 may also include one or more user interfaces 210. User interfaces 210 may be or may include a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and / or any other means for receiving information from a user (such as predetermined pressure and / or flow rate thresholds, borehole depth, borehole duration, etc.) and / or for providing information to a user. User interfaces 210 may be used, for example, to receive user selections or other user input regarding any step of any method described herein. Nevertheless, any required input for any step of any method described herein may be automatically generated by system 200 (e.g., by processor 204 or another component of system 200) or received by system 200 from a source external to system 200. In some embodiments, user interfaces 210 may be used to allow surgeons or other users to modify instructions to be executed by processor 204, and / or modify or adjust settings of other information displayed on or corresponding to user interfaces 210, according to one or more embodiments of this disclosure.

[0059] Although user interface 210 is shown as part of computing device 202, in some embodiments, computing device 202 may utilize user interface 210, which may be housed separately from one or more other components of computing device 202. In some embodiments, user interface 210 may be located near one or more other components of computing device 202, while in other embodiments, user interface 210 may be located away from one or more other components of computing device 202.

[0060] During operation, navigation system 218 can provide navigation for the surgeon and / or surgical robot. Navigation system 218 can be any currently known or future-developed navigation system, including, for example, the Medtronic StealthStation™ S8 surgical navigation system or any subsequent product thereof. Navigation system 218 may include one or more cameras or other sensors for tracking one or more reference markers, navigation trackers, or other objects within the operating room or other room where part or all of system 200 is located. The one or more cameras may be optical cameras, infrared cameras, or other cameras. In some embodiments, the navigation system may include one or more electromagnetic sensors. In various embodiments, navigation system 218 can be used to track the position and orientation (i.e., attitude) of robot 214 and / or robotic arm 216 and / or one or more surgical tools (such as drill 102) (or more specifically, for tracking the attitude of navigation trackers directly or indirectly attached in a fixed relationship to one or more of the aforementioned components). Navigation system 218 may include a display for displaying one or more images from an external source (e.g., computing device 202 or other sources) or for displaying images and / or video streams from one or more cameras or other sensors of navigation system 218. In some embodiments, system 200 may operate without using navigation system 218. Navigation system 218 may be configured to provide guidance to the surgeon or other users of system 200 or its components, to robot 214, or to any other element of system 200 regarding the posture of, for example, one or more anatomical elements and / or whether a drill (such as drill 102) is in the appropriate trajectory, and / or how to move drill 102 into the appropriate trajectory to perform surgical tasks according to preoperative or other surgical plans (such as surgical plan 220).

[0061] Robot 214 can be any surgical robot or surgical robot system. Robot 214 can be, or may include, for example, a Mazor X™ Stealth Robot Guidance System. Robot 214 can be configured to position and orient a drill bit (such as drill bit 102) in one or more precise locations, and / or return drill bit 102 to the same location and orient at a later time. Robot 214 may additionally or alternatively be configured to manipulate surgical instruments such as drill bit 102 (whether or not based on guidance from navigation system 218) to perform or assist surgical tasks. In some embodiments, robot 214 may be configured to hold and / or manipulate anatomical elements during or in conjunction with surgical procedures. Robot 214 may include one or more robotic arms 216. In some embodiments, robotic arms 216 may include a first robotic arm and a second robotic arm, but robot 214 may include more than two robotic arms. In some embodiments, one or more of the robotic arms 216 may be used to hold and / or manipulate drill bit 102.

[0062] The robot 214, together with the robotic arm 216, may have, for example, one, two, three, four, five, six, seven, or more degrees of freedom. Furthermore, the robotic arm 216 can be in any pose, planar, and / or focally positioned or localizable. This pose includes position and orientation. Therefore, the drill 102, surgical instrument, or other object held by the robot 214 (or more specifically, held by the robotic arm 216) can be precisely positioned in one or more desired and specific locations and orientations.

[0063] The robotic arm 216 may include one or more sensors that enable the processor 204 (or the processor of the robot 214) to determine the precise orientation of the robotic arm (and any object or element held or attached to the robotic arm) in space.

[0064] In some embodiments, reference markers (i.e., navigation markers) may be placed on robot 214 (including, for example, on robotic arm 216) or on any other object in the surgical space. The reference markers may be tracked by navigation system 218, and the results of the tracking may be used by the operator of robot 214 and / or system 200 or any of its components. In some embodiments, navigation system 218 may be used to track other components of the system, and the system may operate without using robot 214 (e.g., a surgeon may manually manipulate drill 102 and / or one or more surgical instruments, for example, based on information and / or instructions generated by navigation system 218).

[0065] System 200 or a similar system may be used, for example, to perform one or more aspects of the methods 400 described herein. System 200 or a similar system may also be used for other purposes.

[0066] Go to Figures 3A to 3C The image shows the drill bit 302 of the drilling system 300 in three positions: a first position, a second position, and a third position, to illustrate exemplary use of the drilling system 300. The drilling system 300 can be used in conjunction with the methods described above. Figure 1 The drilling system 100 described is the same as or similar to that described above, and the drill bit 302 is also related to the drilling system 100 described above. Figure 1 The drill bit 102 described is the same as or similar. As previously described, the drilling system 300 can be used to drill into any anatomical element and may be particularly useful where cutting or drilling may occur near any sensitive and / or soft tissue. In some embodiments, the drilling system 300 is used when adjacent soft tissue is cutting or drilling into hard tissue, such as bone. When adjacent hard tissue is cut or drilled, the drilling system 300 advantageously protects sensitive soft tissue from damage.

[0067] like Figure 3AAs shown, drill 302 rotates and advances through lamina 304 of vertebra 306. Although vertebra 306 is shown for illustrative purposes, drill 302 can drill through any anatomical element, particularly any hard tissue anatomical element. For example, in other embodiments, drill 302 can drill through or cut through the skull, where it is desirable to protect brain tissue adjacent to the skull. Drill 302 can be rotated by a motor (such as motor 106). As drill 302 penetrates lamina 304, drill 302 is exposed to anatomical material 310 (such as dura mater, spinal cord, brain tissue, and / or other sensitive tissues) that is sensitive to tearing or damage from drill 302.

[0068] like Figure 3B and Figure 3C As shown, pressurized fluid can be delivered to the hollow shaft 308 of drill bit 302 by a fluid system (such as fluid system 104), and released through orifice 322 of drill bit 302 when drill bit 302 penetrates vertices 304. More specifically, Figure 3B The diagram shows the situation where the tip 324 of the drill bit 302 initially breaks through the lamina 304 and the fluid protective anatomical material 310 is discharged from the orifice 322. Figure 3C This illustrates a scenario where pressurized fluid pushes anatomical material 310 (e.g., dura mater) away from the tip 326 of drill bit 302 to create space for drill bit 302 to complete drilling. As shown, the pressurized fluid can form a barrier 312 between the tip 324 of drill bit 302 and anatomical material 310 to prevent contact between the drill bit 302 and anatomical material 310, which could damage the anatomical material 310. In some cases, pressurized fluid can push anatomical material 310 away from drill bit 302, such as... Figure 3C As shown.

[0069] In some embodiments, orifice 322 is located at the tip 324 of drill bit 302, and once tip 324 penetrates lamina 304, fluid flowing from orifice 322 forms barrier 312. In other embodiments, multiple orifices may be located on surface 326 of drill bit 302. In cases where a different portion of drill bit 302 (e.g., a portion of drill bit 302 not part of tip 324, such as the circumference of drill bit 302) first penetrates lamina 304 (whether due to drilling angle or other reasons), fluid may flow from the orifice that is first exposed (and no longer blocked by lamina 304) to form barrier 312. In other words, fluid may flow from the orifice that first penetrates lamina 304 to form barrier 312.

[0070] As described in more detail below, pressurized fluid may be delivered before the drill bit 302 penetrates the lamina 304 (or any hard tissue) so that a barrier 312 is formed once the drill bit 302 penetrates the lamina 304. Furthermore, the pressure and / or flow rate of the fluid may be monitored to detect changes in fluid pressure and / or flow rate, which may indicate penetration of the lamina 304. Once a decrease in fluid pressure and / or an increase in flow rate is detected, the drill bit 302 may be advanced a predetermined additional distance into the lamina or other tissue to completely drill an exit hole before retraction. During at least the initial period of such advancement and subsequent retraction, pressurized fluid continues to flow from one or more orifices in the drill bit 302 to prevent contact between the drill bit 302 and anatomical material 310, such as the dura mater (or other sensitive anatomical tissue).

[0071] Figure 4 A method 400 is described that can be used, for example, to drill holes in anatomical elements during surgical procedures. In some embodiments, the anatomical element may be a vertebra, and method 400 can be used to prepare a lamina for decompression procedures such as laminectomy or laminectomy. In other embodiments, the anatomical element may be any hard tissue. Method 400 can also be used to drill holes in any hard tissue adjacent to sensitive soft tissue, where it is necessary to protect the sensitive soft tissue or prevent damage to it.

[0072] Method 400 (and / or one or more steps thereof) may be performed, for example, by at least one processor or otherwise. The at least one processor may be the same as or similar to processor 204 of the computing device 202 described above. The at least one processor may be part of a robot (such as robot 214) or a navigation system (such as navigation system 218). Processors other than any of the processors described herein may also be used to perform method 400. The at least one processor may perform method 400 by executing instructions stored in memory (such as memory 206). These instructions may correspond to one or more steps of method 400 described below.

[0073] Method 400 includes a directional drill bit (step 404). The drill bit may be the same as or similar to drill bits 102, 302. The drill bit may be oriented at an anatomical element. In some embodiments, the anatomical element is a vertebra. In other embodiments, the anatomical element may be any hard tissue, such as bone. In some embodiments, a robotic arm (such as robotic arm 216) may automatically oriented the drill bit. Alternatively, a surgeon or user may instruct the robotic arm to oriented the drill bit. In other embodiments, a surgeon or user may manually oriented the drill bit.

[0074] In some embodiments, the robotic arm may orient the drill along a predetermined trajectory based on a surgical plan (such as surgical plan 220). In at least one embodiment, instructions (such as instruction 222) may be generated based on the surgical plan and transmitted to the robotic arm to orient the drill. In other embodiments, the robotic arm may orient the drill based on input from a surgeon or user (e.g., using one or more coordinates, pose information, position information, or orientation information) (which may be received from, for example, a user interface (such as user interface 210)).

[0075] Method 400 also includes rotating the drill bit (step 408). A motor (such as motor 106) can rotate the drill bit. In some embodiments, a processor (such as processor 204) can automatically control the motor to rotate the drill bit. In other embodiments, the motor can rotate the drill bit based on input from a surgeon or user (which may be received from, for example, a user interface). For example, a surgeon or other user can press a trigger or otherwise activate motor 106.

[0076] Step 408 may also include advancing the drill bit. In some embodiments, the drill bit may be advanced by a robotic arm. Alternatively, a surgeon or user may instruct the robotic arm to advance the drill bit. In other embodiments, a surgeon or user may manually advance the drill bit.

[0077] The drill bit can be rotated and advanced for a predetermined time period or distance. A navigation system (such as navigation system 218) can be used to provide indication of the drill bit's drilling depth. The predetermined time period or distance can be based on a surgical plan (such as surgical plan 220) or can be received as input from a surgeon or user via a user interface (such as user interface 210). Alternatively, the surgeon or user can monitor the drill bit (whether by imaging, measuring penetration depth, or otherwise) and advance the drill bit accordingly.

[0078] Method 400 further includes delivering pressurized fluid to a shaft (such as shaft 108 of a drill bit) (step 412). In some embodiments, the drill bit may be in fluid communication with a valve (such as valve 120) that is in fluid communication with a fluid inlet (such as fluid inlet 118). The fluid inlet may be configured to receive pressurized fluid, and the valve may control the delivery of pressurized fluid to the shaft. In some embodiments, step 412 may include opening the valve to release pressurized fluid into the shaft. After the fluid has been delivered to the shaft, fluid is released through at least one orifice (such as at least one orifice 122, 322 disposed on a surface (such as surface 126, 226 of the drill bit)) when it becomes unblocked.

[0079] In some embodiments, fluid may be delivered to the shaft (either by direct delivery of pressurized fluid to the shaft and / or by supplying pressurized fluid to a fluid inlet), and a valve may be opened once the drill bit has been activated for a predetermined time period, reached a predetermined drilling depth, or elapsed for a predetermined drilling time. In other words, the drill bit may drill through a portion of the anatomical element before pressurized fluid is delivered to the shaft. The predetermined time period, predetermined drilling length, and / or predetermined drilling time may be based on a surgical plan (such as surgical plan 220). In other embodiments, fluid may be delivered to the shaft based on input received from a surgeon or user via a user interface (such as user interface 210). In an alternative embodiment, fluid may be continuously delivered to the shaft throughout the drilling process.

[0080] Method 400 further includes monitoring the pressure and / or flow rate of the fluid (step 416). Step 416 may also include receiving sensor data from a sensor (such as sensor 132). The sensor may be any sensor configured to sense the pressure of the fluid (e.g., a pressure sensor) or any sensor configured to measure the flow rate of the fluid (e.g., a flow sensor or flow meter). In some embodiments, the sensor may continuously transmit sensor data to a processor that monitors the pressure and / or flow rate. In other embodiments, the sensor may transmit sensor data to the processor at specific intervals (whether time intervals, depth intervals, etc.). The sensor data may be automatically monitored by the processor and / or, in some cases, displayed on a user interface (such as user interface 210), where the surgeon or user may manually monitor the pressure and / or flow rate.

[0081] The sensor may be in fluid communication with the shaft. In some embodiments, the sensor may be located on the drill bit. In other embodiments, the sensor may be located on a pump, fluid source, fluid inlet, or valve. In still other embodiments, the sensor may be located on any component of a drilling system (such as drilling system 100) or a system (such as system 200).

[0082] Method 400 also includes comparing sensor data with a predetermined threshold (step 420). The predetermined threshold may be obtained from a surgical plan (such as surgical plan 220). In other embodiments, the predetermined threshold may be received from a surgeon or user via a user interface. In some embodiments, the predetermined threshold may be obtained preoperatively or intraoperatively by measuring the pressure and / or flow rate of the pressurized fluid when pressurized fluid is delivered to the shaft (whether by opening a valve or directly to the shaft) and the drill orifice is blocked (by bone, a blockage, or otherwise). In some embodiments, the predetermined threshold may be a relative threshold rather than an absolute threshold. In other words, the predetermined threshold may be a 5% pressure drop, such that once the pressure drop and / or flow rate increase by 5%, the predetermined threshold has been reached.

[0083] Method 400 further includes identifying a decrease in fluid pressure and / or an increase in flow rate based on sensor data (step 424). A decrease in fluid pressure and / or an increase in flow rate can be identified by comparing the fluid pressure and / or flow rate performed in step 420 with a predetermined threshold. When the fluid pressure and / or flow rate reaches or exceeds the predetermined threshold (in an upward or downward direction, as appropriate), an assumption can be made that the drill bit has broken through the bone or other hard tissue being drilled based on the decrease in pressure and / or increase in flow rate. In other embodiments, a decrease in pressure and / or an increase in flow rate can be identified by a surgeon or user viewing the pressure and / or flow rate on a user interface and identifying a decrease in pressure or an increase in flow rate. The surgeon or user can then input the decrease in pressure and / or increase in flow rate via the user interface.

[0084] A decrease in fluid pressure and / or an increase in flow rate indicates when pressurized fluid is released through one or more orifices of the drill bit. More specifically, as the drill bit penetrates an anatomical element (such as bone), the orifices become blocked by bone, and therefore fluid cannot be released through the orifices. When the drill bit penetrates the anatomical element and at least one orifice is exposed to anatomical material less rigid than bone (e.g., dura mater, spinal cord, tissue, brain tissue), fluid is released through at least one orifice, and the fluid pressure decreases and the fluid flow rate increases. When one or both of these changes are detected, it indicates that the drill bit is no longer penetrating bone. It should be understood that some fluid may leak or be released from at least one orifice when the drill bit penetrates an anatomical element (such as bone). Such leakage or release may not be sufficient to cause the fluid pressure to drop to a predetermined threshold. Furthermore, the predetermined threshold may account for such leakage.

[0085] Method 400 further includes advancing the drill bit until a decrease in pressure and / or an increase in flow rate is detected, or the pressure and / or flow rate exceeds a predetermined threshold (in an upward or downward direction, as appropriate) (step 428). In some embodiments, the processor may generate instructions (such as instruction 222) and transmit these instructions to the motor and / or the robotic arm to cause the motor to continue rotating the drill bit and / or to cause the robotic arm to continue advancing the drill bit. In other embodiments, the processor may generate instructions and communicate these instructions to the surgeon or user (e.g., via a user interface) to instruct the surgeon or user to continue advancing the drill bit and / or to continue operating the motor to rotate the drill bit. In still other embodiments, the processor may generate instructions and transmit these instructions to the robotic arm and / or the motor, and generate instructions and communicate these instructions to the surgeon or user. For example, the processor may generate instructions and transmit these instructions to the motor to cause the motor to rotate the drill bit, and may generate instructions and communicate these instructions to the surgeon or user to advance the drill bit.

[0086] Method 400 further includes stopping the drill bit (step 432) when a decrease in pressure and / or an increase in flow rate is detected, and / or when the change in fluid pressure and / or flow rate has reached or exceeded a predetermined threshold. In some embodiments, the processor may generate instructions (such as instruction 222) and transmit these instructions to the motor and / or robotic arm to stop the motor from rotating the drill bit and / or stop the robotic arm from advancing the drill bit. In other embodiments, the processor may generate instructions and communicate these instructions to the surgeon or user (e.g., via a user interface) to instruct the surgeon or user to stop advancing the drill bit and / or stop operating the motor. In still other embodiments, the processor may generate instructions and transmit these instructions to the robotic arm and / or motor, and generate instructions and communicate these instructions to the surgeon or user. For example, the processor may generate instructions and transmit these instructions to the motor to stop the motor from rotating the drill bit, and may generate instructions and communicate these instructions to the surgeon or user to stop advancing the drill bit.

[0087] Step 432 may also include retracting the drill bit. In some embodiments, the processor may generate instructions and transmit these instructions to the robotic arm to retract the drill bit. In other embodiments, the processor may generate instructions and communicate these instructions to a surgeon or user (e.g., via a user interface) to instruct the surgeon or user to retract the drill bit. In some embodiments, pressurized fluid is continuously delivered to the shaft throughout the entire drill bit retraction period. In other embodiments, pressurized fluid is delivered to the shaft for a portion of the drill bit retraction period. For example, pressurized fluid may be delivered to the shaft until the tip of the drill bit penetrates into an anatomical element, such as bone. This ensures that a barrier is in place to protect sensitive anatomical material until the drill bit is no longer at risk of contact with sensitive anatomical material.

[0088] This disclosure covers embodiments of method 400 that include more or fewer steps than those described above, and / or one or more steps that differ from those described above.

[0089] As stated above, this disclosure covers those with less than Figure 4 The method includes all steps identified in the diagram (and the corresponding description of method 400), as well as steps exceeding... Figure 4 The additional steps identified in the document (and the corresponding description of method 400) are methods. This disclosure also covers methods that include one or more steps from one method described herein and one or more steps from another method described herein. Any correlation described herein may be or includes registration or any other correlation.

[0090] The foregoing is not intended to limit this disclosure to the one or more forms disclosed herein. In the foregoing specific embodiments, for example, for the purpose of simplifying this disclosure, various features of this disclosure are grouped together in one or more aspects, embodiments, and / or configurations. Features of aspects, embodiments, and / or configurations of this disclosure may be combined in alternative aspects, embodiments, and / or configurations other than those discussed above.

[0091] Furthermore, while the foregoing has already included descriptions of one or more aspects, embodiments, and / or configurations, as well as certain variations and modifications, other variations, combinations, and modifications may be made within the scope of this disclosure, for example, within the skill and knowledge of those skilled in the art, upon understanding of this disclosure. It is intended to obtain, to the permissible extent, rights including alternative aspects, embodiments, and / or configurations, including alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps of those claimed, regardless of whether such alternative, interchangeable, and / or equivalent structures, functions, scopes, or steps are disclosed herein, and not to disclose for use in any patentable subject matter.

Claims

1. An apparatus for drilling anatomical elements, the apparatus comprising: A drill bit, the drill bit including a coaxial hollow shaft, the coaxial hollow shaft communicating with a plurality of orifices disposed on the surface of the drill bit, one of the plurality of orifices being disposed at the tip of the drill bit and one or more of the plurality of orifices being angularly disposed with respect to the axis of the coaxial hollow shaft; A fluid inlet, which is in fluid communication with the coaxial hollow shaft via a selectively openable valve, is configured to receive pressurized fluid; and When the valve is opened, the pressurized fluid is released into the coaxial hollow shaft, and when at least one of the plurality of orifices is not blocked, the pressurized fluid is released through the at least one of the plurality of orifices.

2. The apparatus according to claim 1, further comprising: At least one processor; and A memory storing instructions for execution by the at least one processor, the instructions causing the at least one processor, when executed, to: The drill bit is rotated and advanced. To open the valve, and The pressure of the fluid is monitored via a pressure sensor that is in fluid communication with the coaxial hollow shaft.

3. The apparatus of claim 2, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: Receive sensor data from the pressure sensor; and The sensor data is compared with a predetermined threshold.

4. The apparatus of claim 3, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: When the pressure of the fluid is higher than the predetermined threshold, the drill bit is advanced.

5. The apparatus of claim 2, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: The valve is opened once the drill bit has been activated for a predetermined time period, the drill bit has reached a predetermined drilling depth, or the predetermined drilling time has elapsed.

6. The apparatus according to claim 1, further comprising: At least one processor; and A memory storing instructions for execution by the at least one processor, the instructions causing the at least one processor, when executed, to: The drill bit is rotated and advanced. To open the valve, and The flow rate of the fluid is monitored via a flow sensor that is in fluid communication with the coaxial hollow shaft.

7. The apparatus of claim 6, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: Receive sensor data from the flow sensor; and The sensor data is compared with a predetermined threshold.

8. An apparatus for drilling anatomical elements, the apparatus comprising: A drill bit, the drill bit including a coaxial hollow shaft, the coaxial hollow shaft communicating with a plurality of orifices disposed on the surface of the drill bit, one of the plurality of orifices being disposed at the tip of the drill bit; At least one processor; and A memory storing instructions for execution by the at least one processor, the instructions causing the at least one processor, when executed, to: Rotate the drill bit. Open the valve to release the pressurized fluid into the coaxial hollow shaft, and The pressure of the fluid is monitored to detect the release of the pressurized fluid through one or more of the plurality of orifices.

9. The apparatus of claim 8, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: Receive sensor data from a sensor configured to measure the pressure of the fluid; and The decrease in pressure of the fluid is identified based on the sensor data.

10. The apparatus of claim 9, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions, when executed, further causing the at least one processor to: The drill bit is advanced until the decrease in the pressure of the fluid is detected.

11. The apparatus of claim 9, wherein the memory stores additional instructions for execution by the at least one processor, the additional instructions further causing the at least one processor, when executed, to: When a decrease in the pressure of the fluid is detected, the drill bit is stopped.

12. The apparatus of claim 9, wherein the plurality of orifices have a non-circular cross-section.

13. A system for drilling anatomical elements, the system comprising: A drill bit configured to drill a anatomical element, the drill bit including a coaxial hollow shaft communicating with at least one orifice disposed on a surface of the drill bit; A fluid system in fluid communication with the coaxial hollow shaft, the fluid system being configured to pressurize a fluid and distribute the pressurized fluid into the coaxial hollow shaft; A motor, operably connected to the drill bit; User interface, the user interface being used to selectively operate the motor; At least one processor; and A memory storing instructions for execution by the at least one processor, the instructions causing the at least one processor, when executed, to: The motor rotates the drill bit. The fluid system pressurizes the fluid and distributes the pressurized fluid into the coaxial hollow shaft, and The pressure of the fluid is monitored to detect the release of the pressurized fluid through the at least one orifice.

14. The system of claim 13, wherein the at least one orifice is coaxial with the coaxial hollow shaft.

15. The system of claim 13, wherein the at least one orifice is a plurality of orifices, and one or more of the plurality of orifices are not coaxial with the coaxial hollow shaft.

16. The system of claim 13, wherein the fluid is at least one of water or salt water.

17. The system of claim 13, further comprising: A robotic arm configured to orient the drill bit.

18. The system of claim 13, wherein the fluid system is configured to distribute the pressurized fluid into the coaxial hollow shaft after a predetermined time period following drill bit activation, at a predetermined drilling depth, or after a predetermined drilling time.

19. The system of claim 13, further comprising: A pressure sensor configured to monitor the pressure of the fluid, wherein the motor is configured to stop when the pressure sensor detects a pressure drop.

20. The system of claim 19, wherein when the pressure sensor detects the pressure drop, a warning is generated and the warning is communicated via the user interface.

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