Systems and methods for forming and injecting reinforcement material into a cavity

Abstract

A system for forming a cavity in an anatomical element according to at least one embodiment of the present disclosure includes: a catheter having an elongate body and an articulated tip, a bore extending through the elongate body to an opening at the articulated tip, and a ball end positioned at the opening, the ball end capable of compressing the anatomical element at the ball end, the ball end removable from the catheter; a robotic arm capable of orienting and operating the catheter; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: cause the robotic arm to operate the catheter to form a cavity in the anatomical element using the ball end, and cause the robotic arm to operate the catheter to insert reinforcement material into the cavity via the bore.

Description

SYSTEMS AND METHODS FOR FORMING AND INJECTING REINFORCEMENTMATERIAL INTO A CAVITYTECHNICAL FIELD

[0001] The present disclosure is generally directed to forming a cavity and injecting reinforcement material such as bone cement into the cavity, and relates more particularly to improved systems and methods for forming and injecting the reinforcement material in a custom formed cavity using a single tool.BACKGROUND

[0002] Flowable reinforcement material such as bone cement may be injected into anatomical elements such as bone to provide support and / or stabilization in weakened, fractured, or broken bone. The flowable reinforcement material may be injected into a void or cavity formed in the bone by a surgeon or other medical provider and may harden after curing.BRIEF SUMMARY

[0003] Example aspects of the present disclosure include:

[0004] A system for forming a cavity in an anatomical element according to at least one embodiment of the present disclosure comprises: a catheter having an elongate body and an articulated tip, a bore extending through the elongate body to at least one opening at the articulated tip, and a ball end positioned at a first opening of the at least one opening, the ball end configured to compress the anatomical element at the ball end, the ball end removable from the catheter; a robotic arm configured to orient and operate the catheter; a processor; and a memory storing data for processing by the processor, the data, when processed, causes the processor to: cause the robotic arm to operate the catheter to form a cavity in the anatomical element using the ball end, and cause the robotic arm to operate the catheter to insert reinforcement material into the cavity via the bore.

[0005] Any of the aspects herein, wherein the anatomical element comprises a vertebral bone.

[0006] Any of the aspects herein, further comprising: an imaging device configured to obtain one or more images of at least the articulated tip and at least a portion of the anatomical element, wherein the one or more images are used to orient the articulated tip relative to the anatomical element.

[0007] Any of the aspects herein, further comprising: a navigation system configured to track a position of the articulated tip based on the one or more images received from the imaging device.

[0008] Any of the aspects herein, wherein the ball end is positioned at an end of a rod, the rod configured to be extended through the bore.

[0009] Any of the aspects herein, wherein the ball end is at least one of fixed or releasably fixed to the end of the rod.

[0010] Any of the aspects herein, wherein the memory stores further data for processing by the processor that, when processed, causes the processor to: cause the robotic arm to remove the ball end from the catheter, wherein the articulated tip remains in the anatomical element while the ball end is removed from the catheter.

[0011] Any of the aspects herein, wherein the at least one opening comprises a plurality of openings.

[0012] A method for forming a cavity in an anatomical element according to at least one embodiment of the present disclosure comprises: forming the cavity in the anatomical element using a ball end of a catheter, the catheter having an elongate body and an articulated tip, a bore extending through the elongate body to an opening at the articulated tip, and the ball end positioned at the opening, the ball end configured to compress the anatomical element at the ball end, the ball end removable from the catheter; removing the ball end from the catheter; and inserting reinforcement material into the cavity via the bore and the opening.

[0013] Any of the aspects herein, further comprising: orienting the catheter at the anatomical element prior to forming the cavity; and removing the catheter from the cavity after the reinforcement material is inserted into the cavity.

[0014] Any of the aspects herein, wherein orienting the catheter and removing the catheter is performed by at least one of a user, a robotic arm of a robot, or a combination of the robotic arm and the user.

[0015] Any of the aspects herein, wherein the forming the cavity includes articulating the ball end of the catheter to compress the anatomical element at the ball end.

[0016] Any of the aspects herein, wherein the ball end of the catheter is operated and oriented by a robotic arm of a robot.

[0017] Any of the aspects herein, wherein the ball end is removed from the catheter by at least one of a robotic arm or a user.

[0018] Any of the aspects herein, wherein the anatomical element comprises a vertebral bone.

[0019] Any of the aspects herein, further comprising: receiving one or more images of at least the articulated tip and at least a portion of the anatomical element from an imaging device, wherein the one or more images are used to orient the articulated tip relative to the anatomical element.

[0020] Any of the aspects herein, further comprising: tracking, using a navigation system, a position of the articulated tip based on the one or more images received from the imaging device.

[0021] Any of the aspects herein, wherein the ball end is positioned at an end of a rod, the rod configured to be extended through the bore.

[0022] A method for forming a cavity in an anatomical element according to at least one embodiment of the present disclosure comprises: orienting a catheter at an anatomical element, the catheter having an elongate body and an articulated tip, a bore extending through the elongate body to an opening at the articulated tip, and a ball end positioned at the opening and articulable by the articulated tip, the ball end configured to compress the anatomical element at the ball end, the ball end removable from the catheter; articulating the ball end to form a cavity in the anatomical element; removing the ball end from the catheter; inserting reinforcement material into the cavity via the bore and the opening; and removing the catheter from the cavity.

[0023] Any of the aspects herein, wherein the catheter is oriented and operated by at least one of a user, a robotic arm of a robot, or a combination of the robotic arm and the user.

[0024] Any aspect in combination with any one or more other aspects.

[0025] Any one or more of the features disclosed herein.

[0026] Any one or more of the features as substantially disclosed herein.

[0027] Any one or more of the features as substantially disclosed herein in combination with any one or more other features as substantially disclosed herein.

[0028] Any one of the aspects / features / embodiments in combination with any one or more other aspects / features / embodiments.

[0029] Use of any one or more of the aspects or features as disclosed herein.

[0030] It is to be appreciated that any feature described herein can be claimed in combination with any other feature(s) as described herein, regardless of whether the features come from the same described embodiment.

[0031] The details of one or more aspects of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the techniques described in this disclosure will be apparent from the description and drawings, and from the claims.

[0032] The phrases “at least one”, “one or more”, and “and / or” are open-ended expressions that are both conjunctive and disjunctive in operation. For example, each of the expressions “at least oneof 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” means A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B and C together. When each one of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or class of elements, such as Xl-Xn, Yl-Ym, and Zl-Zo, the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., XI and X2) as well as a combination of elements selected from two or more classes (e.g., Y1 and Zo).

[0033] The term “a” or “an” entity refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein. It is also to be noted that the terms “comprising”, “including”, and “having” can be used interchangeably.

[0034] The preceding is a simplified summary of the disclosure to provide an understanding of some aspects of the disclosure. This summary is neither an extensive nor exhaustive overview of the disclosure and its various aspects, embodiments, and configurations. It is intended neither to identify key or critical elements of the disclosure nor to delineate the scope of the disclosure but to present selected concepts of the disclosure in a simplified form as an introduction to the more detailed description presented below. As will be appreciated, other aspects, embodiments, and configurations of the disclosure are possible utilizing, alone or in combination, one or more of the features set forth above or described in detail below.

[0035] Numerous additional features and advantages of the present disclosure will become apparent to those skilled in the art upon consideration of the embodiment descriptions provided hereinbelow.BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0036] The accompanying drawings are incorporated into and form a part of the specification to illustrate several examples of the present disclosure. These drawings, together with the description, explain the principles of the disclosure. The drawings simply illustrate preferred and alternative examples of how the disclosure can be made and used and are not to be construed as limiting the disclosure to only the illustrated and described examples. Further features and advantages will become apparent from the following, more detailed, description of the various aspects, embodiments, and configurations of the disclosure, as illustrated by the drawings referenced below.

[0037] Fig. l is a block diagram of a system according to at least one embodiment of the present disclosure;

[0038] Fig. 2 is a view of an end of a catheter according to at least one embodiment of the present disclosure;

[0039] Fig. 3 is a cross-sectional view of the end of the catheter of Fig. 2 and a ball end according to at least one embodiment of the present disclosure;

[0040] Fig. 4 is another cross-sectional view of the end of the catheter of Fig. 2 according to at least one embodiment of the present disclosure;

[0041] Fig. 5 is another view of the end of the catheter according to at least one embodiment of the present disclosure; and

[0042] Fig. 6 is a flowchart according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0043] It should be understood that various aspects disclosed herein may be combined in different combinations than the combinations specifically presented in the description and accompanying drawings. It should also be understood that, depending on the example or embodiment, certain acts or events of any of the processes or methods described herein may be performed in a different sequence, and / or may be added, merged, or left out altogether (e.g., all described acts or events may not be necessary to carry out the disclosed techniques according to different embodiments of the present disclosure). In addition, while certain aspects of this disclosure are described as being performed by a single module or unit for purposes of clarity, it should be understood that the techniques of this disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0044] Before any embodiments of the disclosure are explained in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The disclosure is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Further, the present disclosure may use examples to illustrate one or more aspects thereof. Unless explicitly stated otherwise, the use or listing of one or more examples (which may be denoted by “for example,” “by way of example,” “e.g.,” “such as,” or similar language) is not intended to and does not limit the scope of the present disclosure.

[0045] The terms proximal and distal are used in this disclosure with their conventional medical meanings, proximal being closer to the operator or user of the system, and further from the region of surgical interest in or on the patient, and distal being closer to the region of surgical interest in or on the patient, and further from the operator or user of the system.

[0046] Vertebral augmentation procedures are minimally invasive surgical procedures in which reinforcement material such as bone cement is injected into the vertebral body. The reinforcement material may provide support to the weakened vertebra and may, for example, relieve back pain caused by a vertebral compression fracture. When performing a vertebral augmentation procedure, conventionally multiple tools may be used to form a cavity (e.g. a balloon catheter in the case of balloon kyphoplasty) and inject the bone cement. Further, conventional methods typically require insertion of the tool(s) in at least two sides due to the fixed tip end of the tool used to form the cavity. In other words, the use of a tool with a fixed tip end may result in an asymmetrical cavity and / or cement delivery when using one insertion point. Alternatively, when performing a kyphoplasty procedure in which a balloon is used to form the cavity, the balloon may form a cavity that is larger than desired. Further, the balloon may cause further issues such as, for example, inflating irregularly and causing undesirable modification or damage to the endplates or cortical walls of the vertebra. Additionally, the balloon may unexpectedly break and result in an undesired cavity shape and / or size as well as filling the vertebral body with contrast material. Such contrast material may lead to challenges when using fluoroscopy to image the vertebra.

[0047] Systems and methods for forming a cavity and filling the cavity with reinforcement material using the same catheter are provided. The catheter may include an articulated tip having a ball end for forming the cavity and a bore for delivering reinforcement material to the cavity. Additionally or alternatively, the bore may also be used to remove a sample such as, for example, tissue and / or fluids with or without the use of a vacuum. The removed sample may be used in any application such as, for example, a biopsy. The ball end can be removed after forming the cavity to deliver the reinforcement material through the bore and to the cavity. The catheter can be oriented and operated manually, autonomously by a robotic system, or semi-autonomously by the robotic system and the user. The catheter enables the formation of a cavity of a desirable size and shape through one incision (rather than two as required in conventional methods) and the delivery of reinforcement material through the same catheter.

[0048] Embodiments of the present disclosure provide technical solutions to one or more of the problems of (1) reducing a number of surgical tools or instruments used during a vertebroplasty procedure, (2) forming a custom sized cavity during the vertebral augmentation procedure, (3)reducing operating time, (4) increasing patient safety, and (5) reducing exposure to ionizing radiation.

[0049] Turning first to Fig. 1, a block diagram of a system 100 according to at least one embodiment of the present disclosure is shown. The system 100 may be used to orient and / or operate one or more catheter(s) 122 to form a cavity and to insert a reinforcement material into the cavity, and / or carry out one or more other aspects of one or more of the methods disclosed herein. The system 100 comprises a computing device 102, one or more imaging devices 112, the one or more catheter(s) 122, a robot 114, a navigation system 118, a database 130, and / or a cloud or other network 134. Systems according to other embodiments of the present disclosure may comprise more or fewer components than the system 100. For example, the system 100 may not include the robot 114, the imaging device 112, the navigation system 118, one or more components of the computing device 102, the database 130, and / or the cloud 134.

[0050] The computing device 102 comprises a processor 104, a memory 106, a communication interface 108, and a user interface 110. Computing devices according to other embodiments of the present disclosure may comprise more or fewer components than the computing device 102.

[0051] The processor 104 of the computing device 102 may be any processor described herein or any similar processor. The processor 104 may be configured to execute instructions stored in the memory 106, which instructions may cause the processor 104 to carry out one or more computing steps utilizing or based on data received from the robot 114, the navigation system 118, the database 130, and / or the cloud 134.

[0052] The memory 106 may be or comprise RAM, DRAM, SDRAM, other solid-state memory, any memory described herein, or any other tangible, non-transitory memory for storing computer- readable data and / or instructions. The memory 106 may store information or data useful for completing, for example, any step of the method 600 described herein, or of any other methods. The memory 106 may store, for example, instructions and / or machine learning models that support one or more functions of the robot 114. For instance, the memory 106 may store content (e.g., instructions and / or machine learning models). Such content, if provided as in instruction, may, in some embodiments, be organized into one or more applications, modules, packages, layers, or engines. Alternatively or additionally, the memory 106 may store other types of content or data (e.g., machine learning models, artificial neural networks, deep neural networks, etc.) that can be processed by the processor 104 to carry out the various method and features described herein. Thus, although various contents of memory 106 may be described as instructions, it should be appreciated that functionality described herein can be achieved through use of instructions, algorithms, and / ormachine learning models. The data, algorithms, and / or instructions may cause the processor 104 to manipulate data stored in the memory 106 and / or received from or via the robot 114, the imaging device 112, the database 130, and / or the cloud 134.

[0053] The memory 106 may also store a surgical plan 120. Additionally or alternatively, the surgical plan 120 may also be stored in the database 130. The surgical plan 120 may comprise, for example, one or more steps for performing a surgical procedure such as, for example, a vertebroplasty procedure. For example, the surgical plan 120 may comprise one or more surgical steps for orienting and operating the catheter 122 prior to forming a cavity in an anatomical element such as, for example, a vertebra and filling the cavity with a reinforcement material using the catheter 122.

[0054] The computing device 102 may also comprise a communication interface 108. The communication interface 108 may be used for receiving image data or other information from an external source (such as the robot 114, the imaging device 112, the navigation system 118, the database 130, the cloud 134, and / or any other system or component not part of the system 100), and / or for transmitting instructions, images, or other information to an external system or device (e.g., another computing device 102, the imaging device 112, the robot 114, the navigation system 118, the database 130, the cloud 134, and / or any other system or component not part of the system 100). The communication interface 108 may comprise one or more wired interfaces (e.g., a USB port, an Ethernet port, a Firewire port) and / or one or more wireless transceivers or interfaces (configured, for example, to transmit and / or receive information via one or more wireless communication protocols such as 802.11a / b / g / n, Bluetooth, NFC, ZigBee, and so forth). In some embodiments, the communication interface 108 may be useful for enabling the device 102 to communicate with one or more other processors 104 or computing devices 102, whether to reduce the time needed to accomplish a computing-intensive task or for any other reason.

[0055] The computing device 102 may also comprise one or more user interfaces 110. The user interface 110 may be or comprise a keyboard, mouse, trackball, monitor, television, screen, touchscreen, and / or any other device for receiving information from a user and / or for providing information to a user. The user interface 110 may be used, for example, to receive a user selection or other user input regarding any step of any method described herein. Notwithstanding the foregoing, any required input for any step of any method described herein may be generated automatically by the system 100 (e.g., by the processor 104 or another component of the system 100) or received by the system 100 from a source external to the system 100. In some embodiments, the user interface 110 may be useful to allow a surgeon or other user to modify instructions to be executed by theprocessor 104 according to one or more embodiments of the present disclosure, and / or to modify or adjust a setting of other information displayed on the user interface 110 or corresponding thereto.

[0056] Although the user interface 110 is shown as part of the computing device 102, in some embodiments, the computing device 102 may utilize a user interface 110 that is housed separately from one or more remaining components of the computing device 102. In some embodiments, the user interface 110 may be located proximate one or more other components of the computing device 102, while in other embodiments, the user interface 110 may be located remotely from one or more other components of the computing device 102.

[0057] The imaging device 112 may be operable to image anatomical feature(s) (e.g., a bone, veins, tissue, etc.) and / or other aspects of patient anatomy to yield image data (e.g., image data depicting or corresponding to a bone, veins, tissue, etc.). “Image data” as used herein refers to the data generated or captured by an imaging device 112, including in a machine-readable form, a graphical / visual form, and in any other form. In various examples, the image data may comprise data corresponding to an anatomical feature of a patient, or to a portion thereof and / or any objects (e.g., the catheter 122). The image data may be or comprise a preoperative image, an intraoperative image, a postoperative image, or an image taken independently of any surgical procedure. In some embodiments, a first imaging device 112 may be used to obtain first image data (e.g., a first image) at a first time, and a second imaging device 112 may be used to obtain second image data (e.g., a second image) at a second time after the first time. The imaging device 112 may be capable of taking a 2D image or a 3D image to yield the image data. The imaging device 112 may be or comprise, for example, an ultrasound scanner (which may comprise, for example, a physically separate transducer and receiver, or a single ultrasound transceiver), an O-arm, a C-arm, a G-arm, or any other device utilizing X-ray -based imaging (e.g., a fluoroscope, a CT scanner, or other X-ray machine), a magnetic resonance imaging (MRI) scanner, an optical coherence tomography (OCT) scanner, an endoscope, a microscope, an optical camera, a thermographic camera (e.g., an infrared camera), a radar system (which may comprise, for example, a transmitter, a receiver, a processor, and one or more antennae), or any other imaging device 112 suitable for obtaining images of an anatomical feature of a patient. The imaging device 112 may be contained entirely within a single housing, or may comprise a transmitter / emitter and a recei ver / detector that are in separate housings or are otherwise physically separated.

[0058] In some embodiments, the imaging device 112 may comprise more than one imaging device 112. For example, a first imaging device may provide first image data and / or a first image, and a second imaging device may provide second image data and / or a second image. In still otherembodiments, the same imaging device may be used to provide both the first image data and the second image data, and / or any other image data described herein. The imaging device 112 may be operable to generate a stream of image data. For example, the imaging device 112 may be configured to operate with an open shutter, or with a shutter that continuously alternates between open and shut so as to capture successive images. For purposes of the present disclosure, unless specified otherwise, image data may be considered to be continuous and / or provided as an image data stream if the image data represents two or more frames per second.

[0059] The catheter 122 (which will be discussed in more detail in Figs. 2-5) includes an articulated end 202 and a ball end 206 that is removable from the catheter 122. The ball end 206 can form a cavity in an anatomical element by compressing the anatomical element at the ball end 206. It will be appreciated that in addition to the ball end 206, any portion of the catheter 122 can be used to form the cavity such as, for example, the entire catheter hemisphere formed at an articulated end 202 of the catheter 122. Additionally or alternatively, the catheter 122 may exert force axially to compress one or more features in the cavity. The catheter 122 also includes a bore 208 through which reinforcement material may be delivered to the cavity. Additionally or alternatively, the bore may also be used to remove a sample such as, for example, tissue and / or fluids with or without the use of a vacuum. Thus, the catheter 122 can be used to both form the cavity and to fill the cavity with the reinforcement material through a single opening formed in the patient and the anatomical element.

[0060] The robot 114 may be any surgical robot or surgical robotic system. The robot 114 may be or comprise, for example, the Mazor X™ Stealth Edition robotic guidance system. The robot 114 may be configured to position the catheter 122 at one or more precise position(s) and orientation(s). The robot 114 may additionally or alternatively be configured to manipulate a surgical tool other than the catheter 122 (whether based on guidance from the navigation system 118 or not) to accomplish or to assist with a surgical task. In some embodiments, the robot 114 may be configured to hold and / or manipulate an anatomical element during or in connection with a surgical procedure. The robot 114 may comprise one or more robotic arms 116. In some embodiments, the robotic arm 116 may comprise a first robotic arm and a second robotic arm, though the robot 114 may comprise more than two robotic arms. In some embodiments, one or more of the robotic arms 116 may be used to hold and / or maneuver the catheter 122. Each robotic arm 116 may be positionable independently of the other robotic arm. The robotic arms 116 may be controlled in a single, shared coordinate space, or in separate coordinate spaces.

[0061] The robot 114, together with the robotic arm 116, may have, for example, one, two, three, four, five, six, seven, or more degrees of freedom. Further, the robotic arm 116 may be positioned or positionable in any pose, plane, and / or focal point. The pose includes a position and an orientation. As a result, a catheter 122, surgical tool, or other object held by the robot 114 (or, more specifically, by the robotic arm 116) may be precisely positionable in one or more needed and specific positions and orientations.

[0062] The robotic arm(s) 116 may comprise one or more sensors that enable the processor 104 (or a processor of the robot 114) to determine a precise pose in space of the robotic arm (as well as any object or element held by or secured to the robotic arm).

[0063] In some embodiments, reference markers (e.g., navigation markers) may be placed on the robot 114 (including, e.g., on the robotic arm 116), the catheter 122, or any other object in the surgical space. The reference markers may be tracked by the navigation system 118, and the results of the tracking may be used by the robot 114 and / or by an operator of the system 100 or any component thereof. In some embodiments, the navigation system 118 can be used to track other components of the system and the system can operate without the use of the robot 114 (e.g., with the surgeon manually manipulating the catheter 122 and / or one or more surgical tools, based on information and / or instructions generated by the navigation system 118, for example).

[0064] The navigation system 118 may provide navigation for a surgeon and / or a surgical robot during an operation. The navigation system 118 may be any now-known or future-developed navigation system, including, for example, the Medtronic Stealth Station™ S8 surgical navigation system or any successor thereof. The navigation system 118 may include one or more cameras or other sensor(s) for tracking one or more reference markers, navigated trackers, or other objects within the operating room or other room in which some or all of the system 100 is located. The one or more cameras may be optical cameras, infrared cameras, or other cameras. In some embodiments, the navigation system 118 may comprise one or more electromagnetic sensors. In various embodiments, the navigation system 118 may be used to track a position and orientation (e.g., a pose) of the catheter 122, the robot 114 and / or robotic arm 116, and / or one or more surgical tools (or, more particularly, to track a pose of a navigated tracker attached, directly or indirectly, in fixed relation to the one or more of the foregoing). The navigation system 118 may include a display for displaying one or more images from an external source (e.g., the computing device 102, or other source) or for displaying an image and / or video stream from the one or more cameras or other sensors of the navigation system 118. In some embodiments, the system 100 can operate without the use of the navigation system 118. The navigation system 118 may be configured to provide guidanceto a surgeon or other user of the system 100 or a component thereof, to the robot 114, or to any other element of the system 100 regarding, for example, a pose of one or more anatomical elements, whether or not a tool (such as, for example, the catheter 122) is in the proper trajectory, and / or how to move a tool into the proper trajectory to carry out a surgical task according to a preoperative or other surgical plan.

[0065] The database 130 may store information that correlates one coordinate system to another (e.g., one or more robotic coordinate systems to a patient coordinate system and / or to a navigation coordinate system). The database 130 may additionally or alternatively store, for example, one or more surgical plans (including, for example, pose information about a target and / or image information about a patient’s anatomy at and / or proximate the surgical site, for use by the robot 114, the navigation system 118, and / or a user of the computing device 102 or of the system 100); one or more images useful in connection with a surgery to be completed by or with the assistance of one or more other components of the system 100; and / or any other useful information. The database 130 may be configured to provide any such information to the computing device 102 or to any other device of the system 100 or external to the system 100, whether directly or via the cloud 134. In some embodiments, the database 130 may be or comprise part of a hospital image storage system, such as a picture archiving and communication system (PACS), a health information system (HIS), and / or another system for collecting, storing, managing, and / or transmitting electronic medical records including image data.

[0066] The cloud 134 may be or represent the Internet or any other wide area network. The computing device 102 may be connected to the cloud 134 via the communication interface 108, using a wired connection, a wireless connection, or both. In some embodiments, the computing device 102 may communicate with the database 130 and / or an external device (e.g., a computing device) via the cloud 134.

[0067] The system 100 or similar systems may be used, for example, to carry out one or more aspects of any of the method 600 described herein. The system 100 or similar systems may also be used for other purposes.

[0068] Figs. 2-5 depict the catheter 122 according to at least one embodiment of the present disclosure. The catheter 122 includes an elongate body 204 having the articulated end 202 and a bore 208 (shown in Figs. 3 and 4) extending through the elongate body 204. The catheter 122 includes an opening 216 through which reinforcement material may be delivered from the catheter 122. It will be appreciated that in some embodiments the opening 216 may include more than one opening. Forexample, the opening 216 may include an axial opening (as shown in the illustrated embodiments), one or more radial openings, or a combination thereof.

[0069] During formation of a cavity in an anatomical element (such as, for example, a vertebra), the ball end 206 may be inserted through the bore 208 and positioned at the opening 216 of the elongate body 204, as shown in Fig. 4. As shown, the ball end 206 may be connected to an end of a rod 214. In some embodiments, the ball end 206 may be fixed to the rod 214, though it will be appreciated that in other embodiments, the ball end 206 may be releasably fixed to the rod 214. For example, the rod 214 may be used to position the ball end 206 at the opening, then detached from the ball end 206 and removed from the catheter 122. The rod 214 can then be inserted in the catheter 122, attached to the ball end 206 and used to remove the ball end 206 from the opening 216 and the catheter 122. In some embodiments, the ball end 206 is not attached to a rod and may be, for example, simply inserted into the opening 216 and / or removed from the opening 216.

[0070] In some embodiments, the catheter 122 may include one or more ball ends 206 that are interchangeable. For example, a first ball end may include a smooth or spherical ball end and a second ball end may include a roughened or irregular surface. In another example, the ball end 206 may include a conical tip. The different ball end (s) may be used for, for example, drilling, grinding, deburring, etc. the cavity. The different ball end(s) may also be used to, for example, produce different surface finishes in the cavity. Thus, the catheter 122 may be used with one or more ball ends 206 with different tips and / or finishes.

[0071] The articulated end 202, and thus the ball end 206, is movable by one or more push-pull tendons that can be actuated to move the articulated end 202 in a corresponding direction, as shown in Fig. 5. The articulated end 202 and the ball end 206 (or any portion of the catheter 122) can form a cavity in an anatomical element by compressing the anatomical element at the ball end 206. In at least one embodiment, to achieve the desired force to compress the anatomical element and form the cavity, multiple push-pull tendons 212 may be used for each degree of freedom of the articulated end 202. Further, the catheter 122 may include an inner tube 210 positioned within the elongate body 204 that has a thicker wall than the elongate body 204 to enable the inner tube 210 to receive higher loads from the push-pull tendons 212. In other words, the inner tube 210 is nested in the elongate body 204 to form two concentric tubes and the push-pull tendons 212 are positioned between the two tubes. When a push-pull tendon 212 is actuated, the push-pull tendon 212 pushes against the inner tube 210, which bends the inner tube 210 and the elongate body 204, and thus bends the articulated end 202. It will be appreciated that the desired forces may be achieved using other designs not described in this disclosure.

[0072] The ball end 206 can be used to form an opening in the anatomical element, then the ball end 206 can be used to form a cavity in the anatomical element. Because the articulated end 202 and the ball end 206 are articulable in any direction, the cavity can be formed to any custom shape and / or size. Further, the cavity can be formed from a single incision or opening formed in the patient and the anatomical element. It will be appreciated that in other embodiments the ball end 206 along with the articulated end 202 (or any portion of the catheter 122) may form the cavity by, for example, cutting or drilling the anatomical element. In other embodiments, the ball end 206 and / or the articulated end 202 may form the cavity using any combination of cutting, drilling, and / or compressing the anatomical element.

[0073] In some examples, the ball end 206 may be formed of a material different than the elongate body 204 of the catheter 122. In other examples, the ball end 206 may be formed with the same material as the elongate body 204. The elongate body 204 and / or the ball end 206 may be formed from, for example, a biocompatible material. The biocompatible material may be, for example, medical grade stainless steel or any medical grade polymer.

[0074] After the cavity is formed in the anatomical element, the ball end 206 may be removed from the opening 216. In some embodiments, the ball end 206 is removed while the catheter 122 is still in place and the articulated end 202 is in the cavity. In other embodiments, the ball end 206 may be removed after the catheter 122 is removed from the anatomical element, then the catheter 122 may be reinserted into the anatomical element. Reinforcement material may then be delivered to the cavity through the bore 208 and out of the opening 216 into the cavity. The reinforcement material may be, for example, bone cement, bone filler, or any other material that can be hardened when cured. In some embodiments, the bone cement may be, for example, Polymethyl methacrylate (PMMA) based bone cements, Calcium Phosphate, Calcium Sulphate, or other cements. It will be appreciated that other fluids and / or solids may alternatively or additionally be inserted through the bore 208 - or removed from an area near the opening 216. In other words, the catheter 122 may deliver any fluids and / or solids to the opening 216 and / or remove any fluids and / or solids from the opening 216. For example, fluids may be delivered to the opening 216 to flush the cavity. In another example, fluids and / or particulates may be suctioned or vacuumed from the cavity.

[0075] It will be appreciated that the catheter 122 can be manually oriented and / or operated by a user, autonomously oriented and / or operated by, for example, the robotic arm 116 and the robot 114, and / or semi-autonomously oriented and / or operated by the user, the robotic arm 116, and the robot 114.

[0076] Fig. 6 depicts a method 600 that may be used, for example, for forming a cavity in an anatomical element and injecting a reinforcement material into the cavity. The method 600 may use a system such as the system 100 to execute one or more steps of the method 600. In some embodiments, one or more steps may be executed automatically by, for example, a robot such as the robot 114 of the system. In other embodiments, one or more steps may be executed manually by a user such as, for example, a surgeon or other medical provider. In still other embodiments, one or more steps may be executed semi-autonomously by the robot and the user. For example, a step may require the input or approval of the user before being executed by the robot. It will be appreciated that the method 600 may include any combination of steps being performed autonomously by the robot, semi-autonomously by the robot and the user, and / or manually by the user.

[0077] The method 600 comprises positioning a catheter (step 604). The catheter may be the same as or similar to the catheter 122. The catheter may include an elongate body such as the elongate body 204 extending to an articulated tip such as the articulated end 202 and a bore such as the bore 208 that extends through the elongate body to an opening such as the opening 216. The catheter may include a ball end such as the ball end 206 that may be inserted through the bore and positioned at the opening. The ball end can be used to, for example, compress material in an anatomical element to form an opening or port in the anatomical element and to form a cavity in the anatomical element. In some embodiments, the catheter may include one or more ball ends that are interchangeable. For example, a first ball end may include a smooth or spherical ball end and a second ball end may include a roughened or irregular surface. The different ball end(s) may be used for, for example, drilling, grinding, deburring, etc. the cavity. The different ball end(s) may also be used to, for example, produce different surface finishes in the cavity.

[0078] The catheter can be positioned manually by a user such as, for example, a surgeon or other medical provider or autonomously by a robotic arm such as the robotic arm 116 of a robot such as the robot 114. In other examples, the catheter may be positioned semi-autonomously using the robot and the user. The catheter may be positioned at, for example, a target anatomical element which may be a vertebra. It will be appreciated that in other embodiments, the anatomical element may be any anatomical element such as, for example, any bone, hard tissue, organ, or soft tissue. The catheter may be positioned based on one or more target poses stored in, for example, a surgical plan such as the surgical plan 120. In other embodiments, the target poses may be determined based on, for example, imaging of the target anatomical element taken preoperatively or intraoperatively.

[0079] In any example, the catheter may be positioned using imaging obtained from, for example, an imaging device such as the imaging device 112. The images may be used to determine a pose ofthe catheter and / or a pose of the articulated tip with respect to the target anatomical element. The images may also be used by, for example, a navigation system such as the navigation system 118 to provide navigation of the catheter to the robot, robotic arm, and / or the user. In some embodiments, the images may be ultrasound images obtained from an ultrasound imaging device. In other embodiments, the images may be X-ray images obtained from an X-ray imaging device. The navigation system may, in other instances, use sensors such as, for example, electromagnetic sensors on the catheter to determine the pose of the catheter and / or the articulated tip.

[0080] The method 600 also comprises forming a cavity with the catheter (step 608). The cavity may be formed using the articulated tip and the ball end. As previously described, the articulated tip and the ball end are movable by one or more push-pull tendons such as the one or more push-pull tendons 212 that can be actuated to move the articulated tip in a corresponding direction. The one or more push-pull tendons may be actuated manually by the user, automatically by the robotic arm, or semi-autonomously by the user and the robotic arm. The ball end and / or the articulated end (or any portion of the catheter) can form the cavity in the anatomical element by compressing the anatomical element at the ball end and / or the articulated end. Because the articulated tip and the ball end are articulable in any direction, the cavity can be formed to any custom shape and / or size.

[0081] A target shape and / or size of the cavity may be stored in, for example, the surgical plan. In other embodiments, the shape and / or size of the cavity may be determined based on images of the anatomical element obtained preoperatively and / or intraoperatively.

[0082] The method 600 also comprises removing the ball end from the catheter (step 610). The ball end may be connected to an end of a rod such as the rod 214. In some embodiments, the ball end may be fixed to the rod, though it will be appreciated that in other embodiments, the ball end may be releasably fixed to the rod. For example, the rod may be used to position the ball end at the opening, then detached from the ball end and removed from the catheter. The rod can then be inserted in the catheter, attached to the ball end and used to remove the ball end from the opening and the catheter. In other embodiments, the ball end may not be attached to a rod and may be inserted or removed from the articulated tip without the rod. In any embodiment, the ball end may be removed from the catheter without removing the catheter from the anatomical element, which beneficially reduces operating time as two separate tools do not need to be removed and inserted.

[0083] In some embodiments, it will be appreciated that a balloon may be inserted into the cavity and inflated to further shape and form the cavity. In other embodiments, the balloon may not be inserted into the cavity.

[0084] The method 600 also comprises inserting a reinforcement material into the cavity (step 612). Reinforcement material may be delivered to the cavity through the bore and out of the opening into the cavity. The reinforcement material may be, for example, bone cement, bone filler, or any other material that can be hardened when cured. A predetermined amount of reinforcement material may be inserted based on a volume of the cavity. In other embodiments, the reinforcement material may be inserted until the cavity is full and reinforcement material can no longer be inserted. In some embodiments, the location of delivery of the reinforcement material may be controlled by the articulated end. In other words, the articulated end may be articulated during delivery of the reinforcement material to control the location of the reinforcement material within the cavity.

[0085] The method 600 also comprises removing the catheter from the cavity (step 616). The catheter may be removed from the cavity and the patient manually by the user, automatically by the robotic arm, or semi-autonomously by the user and the robotic arm.

[0086] The present disclosure encompasses embodiments of the method 600 that comprise more or fewer steps than those described above, and / or one or more steps that are different than the steps described above.

[0087] As noted above, the present disclosure encompasses methods with fewer than all of the steps identified in Fig. 6 (and the corresponding description of the method 600) as well as methods that include additional steps beyond those identified in Fig. 6 (and the corresponding description of the method 600). The present disclosure also encompasses methods that comprise 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 comprise a registration or any other correlation.

[0088] The catheter 122 beneficially increases a patient’s safety during a surgical procedure such as, for example, a vertebroplasty procedure. The formation of a cavity and insertion of reinforcement material into the cavity can be achieved with a single catheter 122 and without removal of the catheter 122 from the cavity, thus reducing time needed to perform the surgical procedure. Further the surgical procedure can be done through a single opening or port formed in the anatomical element, as opposed to conventional procedures which typically require the formation of two or more openings or ports in the anatomical element. Additionally, the catheter 122 enables the formation of a custom cavity, thereby preventing undesired compression of the anatomical element.

[0089] The foregoing is not intended to limit the disclosure to the form or forms disclosed herein. In the foregoing Detailed Description, for example, various features of the disclosure are grouped together in one or more aspects, embodiments, and / or configurations for the purpose of streamlining the disclosure. The features of the aspects, embodiments, and / or configurations of the disclosure maybe combined in alternate aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that the claims require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed aspect, embodiment, and / or configuration. Thus, the following claims are hereby incorporated into this Detailed Description, with each claim standing on its own as a separate preferred embodiment of the disclosure.

[0090] Moreover, though the foregoing has included description of one or more aspects, embodiments, and / or configurations and certain variations and modifications, other variations, combinations, and modifications are within the scope of the disclosure, e.g., as may be within the skill and knowledge of those in the art, after understanding the present disclosure. It is intended to obtain rights which include alternative aspects, embodiments, and / or configurations to the extent permitted, including alternate, interchangeable and / or equivalent structures, functions, ranges or steps to those claimed, whether or not such alternate, interchangeable and / or equivalent structures, functions, ranges or steps are disclosed herein, and without intending to publicly dedicate any patentable subject matter.

[0091] A set of example statements is provided below:

[0092] Statement 1 : A system for forming a cavity in an anatomical element, the system comprising: a catheter (122) having an elongate body (204) and an articulated tip (202), a bore (208) extending through the elongate body (204) to at least one opening (216) at the articulated tip (202), and a ball end (206) positioned at a first opening of the at least one opening (216), the ball end (206) configured to compress the anatomical element at the ball end (206), the ball end (206) removable from the catheter (122); a robotic arm (116) configured to orient and operate the catheter (122); a processor (104); and a memory (106) storing data for processing by the processor (104), the data, when processed, causes the processor (104) to: cause the robotic arm (116) to operate the catheter (122) to form a cavity in the anatomical element using the ball end (206), and cause the robotic arm (116) to operate the catheter (122) to insert reinforcement material into the cavity via the bore (208).

[0093] Statement 2: The system of Statement 1, wherein the anatomical element comprises a vertebral bone.

[0094] Statement 3: The system of any of Statements 1-2, further comprising: an imaging device (112) configured to obtain one or more images of at least the articulated tip (202) and at least a portion of the anatomical element, wherein the one or more images are used to orient the articulated tip (202) relative to the anatomical element.

[0095] Statement 4: The system of Statement 3, further comprising: a navigation system (118) configured to track a position of the articulated tip (202) based on the one or more images received from the imaging device (112).

[0096] Statement 5: The system of any of Statements 1-4, wherein the ball end (206) is positioned at an end of a rod (214), the rod (214) configured to be extended through the bore (208).

[0097] Statement 6: The system of Statement 5, wherein the ball end (206) is at least one of fixed or releasably fixed to the end of the rod (214).

[0098] Statement 7: The system of any of Statements 1-6, wherein the memory (106) stores further data for processing by the processor (104) that, when processed, causes the processor (104) to: cause the robotic arm (116) to remove the ball end (206) from the catheter (122), wherein the articulated tip (202) remains in the anatomical element while the ball end (206) is removed from the catheter (122).

[0099] Statement 8: The system of any of Statements 1-7, wherein the at least one opening (216) comprises a plurality of openings.

[0100] Statement 9: A method for forming a cavity in an anatomical element, the method comprising: forming the cavity in the anatomical element using a ball end (206) of a catheter (122), the catheter (122) having an elongate body (204) and an articulated tip (202), a bore (208) extending through the elongate body (204) to an opening (216) at the articulated tip (202), and the ball end (206) positioned at the opening (216), the ball end (206) configured to compress the anatomical element at the ball end (206), the ball end (206) removable from the catheter (122); removing the ball end (206) from the catheter (122); and inserting reinforcement material into the cavity via the bore (208) and the opening (216).

[0101] Statement 10: The method of Statement 9, further comprising: orienting the catheter (122) at the anatomical element prior to forming the cavity; and removing the catheter (122) from the cavity after the reinforcement material is inserted into the cavity.

[0102] Statement 11 : The method of Statement 10, wherein orienting the catheter (122) and removing the catheter (122) is performed by at least one of a user, a robotic arm (116) of a robot (114), or a combination of the robotic arm (116) and the user.

[0103] Statement 12: The method of any of Statements 9-11, wherein the forming the cavity includes articulating the ball end (206) of the catheter (122) to compress the anatomical element at the ball end (206).

[0104] Statement 13: The method of Statement 12, wherein the ball end (206) of the catheter (122) is operated and oriented by a robotic arm (116) of a robot (114).

[0105] Statement 14: The method of any of Statements 9-13, wherein the ball end (206) is removed from the catheter (122) by at least one of a robotic arm (116) or a user.

[0106] Statement 15: The method of any of Statements 9-14, wherein the anatomical element comprises a vertebral bone.

[0107] Statement 16: The method of any of Statements 9-15, further comprising: receiving one or more images of at least the articulated tip (202) and at least a portion of the anatomical element from an imaging device (112), wherein the one or more images are used to orient the articulated tip (202) relative to the anatomical element.

[0108] Statement 17: The method of Statement 16, further comprising: tracking, using a navigation system (118), a position of the articulated tip (202) based on the one or more images received from the imaging device (112).

[0109] Statement 18: The method of any of Statements 9-17, wherein the ball end (206) is positioned at an end of a rod (214), the rod (214) configured to be extended through the bore (208).

[0110] Statement 19: A method for forming a cavity in an anatomical element, the method comprising: orienting a catheter (122) at an anatomical element, the catheter (122) having an elongate body (204) and an articulated tip (202), a bore (208) extending through the elongate body (204) to an opening (216) at the articulated tip (202), and a ball end (206) positioned at the opening (216) and articulable by the articulated tip (202), the ball end (206) configured to compress the anatomical element at the ball end (206), the ball end (206) removable from the catheter (122); articulating the ball end (206) to form a cavity in the anatomical element; removing the ball end (206) from the catheter (122); inserting reinforcement material into the cavity via the bore (208) and the opening (216); and removing the catheter (122) from the cavity.[OHl] Statement 20: The method of Statement 19, wherein the catheter (122) is oriented and operated by at least one of a user, a robotic arm (116) of a robot (114), or a combination of the robotic arm (116) and the user.

Claims

CLAIMS1. A system for forming a cavity in an anatomical element, the system comprising: a catheter (122) having an elongate body (204) and an articulated tip (202), a bore (208) extending through the elongate body (204) to at least one opening (216) at the articulated tip (202), and a ball end (206) positioned at a first opening of the at least one opening (216), the ball end (206) configured to compress the anatomical element at the ball end (206), the ball end (206) removable from the catheter (122); a robotic arm (116) configured to orient and operate the catheter (122); a processor (104); and a memory (106) storing data for processing by the processor (104), the data, when processed, causes the processor (104) to: cause the robotic arm (116) to operate the catheter (122) to form a cavity in the anatomical element using the ball end (206), and cause the robotic arm (116) to operate the catheter (122) to insert reinforcement material into the cavity via the bore (208).

2. The system of claim 1, wherein the anatomical element comprises a vertebral bone.

3. The system of any of claims 1-2, further comprising: an imaging device (112) configured to obtain one or more images of at least the articulated tip (202) and at least a portion of the anatomical element, wherein the one or more images are used to orient the articulated tip (202) relative to the anatomical element.

4. The system of claim 3, further comprising: a navigation system (118) configured to track a position of the articulated tip (202) based on the one or more images received from the imaging device (112).

5. The system of any of claims 1-4, wherein the ball end (206) is positioned at an end of a rod (214), the rod (214) configured to be extended through the bore (208).

6. The system of claim 5, wherein the ball end (206) is at least one of fixed or releasably fixed to the end of the rod (214).

7. The system of any of claims 1-6, wherein the memory (106) stores further data for processing by the processor (104) that, when processed, causes the processor (104) to: cause the robotic arm (116) to remove the ball end (206) from the catheter (122), wherein the articulated tip (202) remains in the anatomical element while the ball end (206) is removed from the catheter (122).

8. The system of any of claims 1-7, wherein the at least one opening (216) comprises a plurality of openings.

9. A method for forming a cavity in an anatomical element, the method comprising: forming the cavity in the anatomical element using a ball end (206) of a catheter (122), the catheter (122) having an elongate body (204) and an articulated tip (202), a bore (208) extending through the elongate body (204) to an opening (216) at the articulated tip (202), and the ball end (206) positioned at the opening (216), the ball end (206) configured to compress the anatomical element at the ball end (206), the ball end (206) removable from the catheter (122); removing the ball end (206) from the catheter (122); and inserting reinforcement material into the cavity via the bore (208) and the opening (216).

10. The method of claim 9, further comprising: orienting the catheter (122) at the anatomical element prior to forming the cavity; and removing the catheter (122) from the cavity after the reinforcement material is inserted into the cavity.

11. The method of claim 10, wherein orienting the catheter (122) and removing the catheter (122) is performed by at least one of a user, a robotic arm (116) of a robot (114), or a combination of the robotic arm (116) and the user.

12. The method of any of claims 9-11, wherein the forming the cavity includes articulating the ball end (206) of the catheter (122) to compress the anatomical element at the ball end (206).

13. The method of claim 12, wherein the ball end (206) of the catheter (122) is operated and oriented by a robotic arm (116) of a robot (114).

14. The method of any of claims 9-13, wherein the ball end (206) is removed from the catheter (122) by at least one of a robotic arm (116) or a user.

15. A method for forming a cavity in an anatomical element, the method comprising: orienting a catheter (122) at an anatomical element, the catheter (122) having an elongate body (204) and an articulated tip (202), a bore (208) extending through the elongate body (204) to an opening (216) at the articulated tip (202), and a ball end (206) positioned at the opening (216) and articulable by the articulated tip (202), the ball end (206) configured to compress the anatomical element at the ball end (206), the ball end (206) removable from the catheter (122); articulating the ball end (206) to form a cavity in the anatomical element; removing the ball end (206) from the catheter (122); inserting reinforcement material into the cavity via the bore (208) and the opening (216); and removing the catheter (122) from the cavity.

Images