Surgical robotic tools providing arm stabilization and tissue protection

Abstract

A tool combines both stabilization and shielding components for protecting a patient's sensitive tissues, such as a spinal cord, during robotic spinal and other procedures. The combination stabilization-shielding tool is mounted on a first surgical robot arm and an operative surgical tool is mounted on a second surgical robot arm. The first surgical robot arm is positioned both to engage the stabilizing element against a stabilizing location on the patient's bony anatomy and to locate the shielding element between a target location and the sensitive tissue. The second surgical robot arm is positioned to place the operative surgical tool at the target location, and the robotic surgical procedure is performed while the stabilizing element remains engaged with the stabilizing location on the patient's bony anatomy and the shielding element remains positioned between the target anatomy and the sensitive tissue.

Description

Atorney Docket No. 67551-721601; P403074WOSURGICAL ROBOTIC TOOLS PROVIDING ARM STABILIZATION AND TISSUE PROTECTIONCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This PCT application claims the benefit of U.S. Provisional Application 63 / 697,239[Attorney Docket No. 67551-721.101], filed on September 20, 2024, the full disclosure of which is incorporated herein by reference.BACKGROUND

[0002] 1, Field. The disclosed technology relates generally to medical apparatus and methods and, more particularly, to surgical robotic tools, systems, and methods for stabilizing surgical robotic arms and protecting adjacent tissues during surgical robotic procedures.

[0003] Robotic surgery and surgical robots are now in common use. A typical robotic surgical procedure uses multiple surgical tools deployed on two, three, or more surgical robotic arms under the control of a surgical robotic controller. The surgical robotic arms and the tools they carry are typically navigated using robotically controlled cameras and / or other sensors, often in combination with kinematic tracking and placement of the surgical robotic arms and surgical tools.

[0004] Certain robotic surgical procedures require that the robotic arms apply large forces to the patient anatomy. For example, milling bone for spinal decompression and drilling a vertebra for pedicle screw placement both exert significant force and torque on the spine, resulting in counter forces that can displace the drills and screwdrivers being used. Even a small displacement can deviate the intended trajectory of the drill and / or pedicle screw which can materially reduce the quality of the screw placement. In addition to the potential loss of surgical tool trajectory, the application of high forces to the bony or other anatomy increases the risk of injury to sensitive organs, such as nerves in the spinal column which are adjacent to areas that may be milled.

[0005] To address these concerns, surgical robots which are intended for use in spinal and other orthopedic procedure which involve drilling, sawing, and grinding bone will utilize heavy- duty robot arms which can resist significant counter forces. It has been found, however, that the counter forces encountered in some spinal and other robotic surgical procedures can exceed the capability of even heavy-duty robotic arms to hold a stable trajectory by themselves.Attorney Docket No. 67551-721601; P403074WO

[0006] A first approach for maintaining of tool trajectory in robotic spinal surgical procedures is described in commonly owned U.S. Patent Publication No. 2024 / 0358460 (Application No. 18 / 767,761), filed on July 9, 2024, entitled TWO-TOOL ANATOMY STABILIZATION, the full disclosure of which is incorporated herein by reference. That application describes stabilizing a vertebral body or other bony anatomy location by engaging a first location on the bony anatomy with a first tool or implant held by a first robotic arm while a second tool held by a second robotic arm performs a procedure on the vertebral body. The first tool optionally penetrates the bony anatomy at the first location to stabilize the position of the vertebral body relative to the second tool thus reducing deviations from the intended second tool trajectory relative to the vertebral body.

[0007] A second approach for improving the maintenance of tool trajectory in spinal surgical procedures has been described in commonly owned PCT Publication W02005 / 036864 (Application No. PCT / EP2024 / 072673), filed on August 09, 2024, entitled STABILIZATION OF ROBOTIC ARMS, the full disclosure of which is incorporated herein by reference. This application describes coupling a stabilization member held by a first robotic surgical arm with a second surgical robotic arm to stabilize a trajectory for a tool held by the second arm.

[0008] In addition to disruption of a tool’s trajectory, the application of high tool forces increases both the risk and the extent of potential damage to adjacent nerves and other sensitive tissues. One approach for protecting adjacent sensitive tissue uses a protective barrier or shield supported by an additional surgical robotic arm as described in commonly owned US Publication US2024 / 0261046 (U.S. Patent Application No. 18 / 613,961), filed on September 18, 2023, entitled SYNCHRONIZED ROBOTIC BONE MILLING, the full disclosure of which is incorporated herein by reference.

[0009] While very effective for their intended purposes, both the use of separate stabilization tools and shielding tools occupies two separate surgical robotic arms in addition to the arm(s) which are deploying the drills, grinders, drivers or other operative tools performing the surgical procedure.

[0010] For these reasons, there is a need for surgical robotic apparatus, systems, and methods that both stabilize the surgical robotic arms which carry the operative tools and protect adjacent sensitive nerves and other tissues which are in proximity to the operative tolls while in use. Such surgical robotic apparatus, systems, and methods should require the use of only a single robotic arm to achieve both the stabilization and protective functions, and in some instances at leastAtorney Docket No. 67551-721601; P403074WO might be implemented by a surgical robotic arm that supports another function, such as holding a camera, another operative tool, or the like. These surgical robotic apparatus, systems, and methods should be useful in a variety of robotic surgical settings and should not be limited to use in spinal and other heavy duty surgical procedures. Such apparatus, systems and methods should preferably require minimum or no modification to the surgical robotic system itself and should instead allow existing (non-modified) components of the surgical robotic systems, such as a single non-modified surgical robotic arm, to be used both to stabilize the patient bony or other anatomy and to protect sensitive patient tissues while another tool held by another surgical arm is performing an operation on the anatomy. At least some of these objectives will be met by the technologies disclosed herein.

[0011] 2, Background Art. Commonly owned publications and applications describing surgical robots and tools include US2024 / 0358460; PCT Publications: WO2025 / 036864;WO2022 / 195460; WO2023 / 067415; WO2023 / 118984; WO2023 / 118985; WO2023 / 144602; WO2023 / 152561; WO2023 / 223215; WO2023 / 237922; WO2025 / 036864; US2024 / 0358460;PCT Applications: PCT / IB2023 / 055439; PCT / IB2023 / 055662; PCT / EP2024 / 052338;PCT / IB2023 / 055663; PCT / EP2024 / 052338; PCT / IB2023 / 056911; PCT / EP2024 / 052353; PCT / EP2024 / 068766; and US Provisional Applications: 63 / 568,102, 63 / 578,395; 63 / 606,001; 63 / 609,490; 63 / 615,076; 63 / 634161, the full disclosures of which are incorporated herein by reference. Articulated arms for holding surgical tools during surgical procedures are described in US Patent Nos. 4,431,329; US3,910,538 and US D644085, assigned to Baitella AG and are commercially available under the Fisso tradename. Other relevant patent publications include US 9763741 to Alvarez et al. and US 11786206 to Steines et al.SUMMARY

[0012] The present disclosure provides methods and apparatus used while performing robotic surgical procedures on a patient’s anatomy. The term “procedure” as used herein designates any step or series of steps a robotic surgery that is performed by a surgical robot on a patient anatomy, such as but not limited to a bony anatomy such as the patient’s spine. Exemplary procedures include but are not limited to decompression, laminectomy, drilling, grinding, distraction, inserting screws and implants, and the like, performed on the spine adjacent to a patient’s spinal cord. Other target bony anatomies include hips, knees, ankles, and procedures including prosthetic implantations.Atorney Docket No. 67551-721601; P403074WO

[0013] In a first aspect, the technologies disclosed herein provide methods for performing a robotic surgical procedure at a target location on a patient’s bony or other anatomy where the target location is typically adjacent to nerves or other sensitive tissues. The methods are particularly useful for protecting a patient’s spinal cord or other nerves during robotic spinal procedures. The methods comprise mounting a combination stabilization-shielding tool on a first surgical robot arm, mounting an operative surgical tool on a second surgical robot arm, and positioning the first surgical robot arm to engage a stabilizing element of the combination stabilization-shielding tool against a stabilizing location on the patient’s bony anatomy and locate a shielding element of the combination stabilization-shielding tool between the target location on the patient’s bony anatomy and the sensitive tissue. A second surgical robot arm is positioned to place the operative surgical tool at the target location, and the robotic surgical procedure is performed at a target location with the operative surgical tool while the stabilizing element remains engaged with the stabilizing location on the patient’s bony anatomy and the shielding element remains positioned between the target location on the patient’s bony anatomy and the sensitive tissue.

[0014] In some instances, the stabilizing element may penetrate the bony or other anatomy.

[0015] In other instances, the stabilizing element may engage the bony or other anatomy without penetration.

[0016] The operative procedures may comprise one or more of decompression, laminectomy, drilling, grinding, distraction, and screwing.

[0017] The operative procedures may further comprise placing an implant.

[0018] In some instances, the target and stabilizing locations are in a single vertebra.

[0019] In other instances, the target and stabilizing locations are in separate vertebra.

[0020] These methods are typically implemented using a robotic surgical controller which is part of the surgical robot. In most cases the surgical robot arms and / or the surgical tools will be operated by the surgeon using an interface such as a display screen on the surgical robot, a remote workstation including optical and / or other sensor-based imaging and tracking capabilities, or the like. In other instances, control of the surgical robot arms and / or the surgical tools may be performed partly or entirely automatically by the surgical robotic controller, for example according to a pre-planned robotic surgical procedure.

[0021] In a second aspect, the technologies disclosed herein provide combination stabilizationshielding tools, typically configured for use with a surgical robot. Such tools typically comprise aAtorney Docket No. 67551-721601; P403074WO structure configured to be held by an arm of the surgical robot, where the structure comprises a stabilizing element and a shielding element. The stabilizing element is typically configured to be engaged against a stabilizing location on a patient’s bony anatomy, and the shielding element is typically configured to be positioned between a target location on the patient’s bony anatomy and a sensitive tissue location adjacent to the target location when the stabilizing element is engaged against the stabilizing location.

[0022] In some instances, the structure is configured to be held by a tool holder mounted on a distal end of the surgical robot arm.

[0023] In some instances, the stabilizing element and the shielding element are repositionable relative to each other. For example, the stabilizing element and the shielding element may be manually repositionable. Alternatively, the stabilization-shielding tool may comprise a motor configured to reposition the stabilizing element relative to the shielding element.

[0024] In some instances, the stabilizing element may comprise a shaft having a distal end configured to engage the stabilizing location on a patient’s bony anatomy. For example, the shaft may be configured to be removably positioned in a gripper of a tool holder.

[0025] In some instances, the shielding element may comprise a semi-cylindrical barrier having an open trough for receiving a milling tool.

[0026] In some instances, the stabilizing element and the shielding element are joined by an adjustable mechanical linkage.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The novel features of the disclosure are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present disclosure will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the disclosure are utilized, and the accompanying drawings of which:

[0028] FIG.1 is a perspective view of a prior art surgical robot having first and second surgical robotic arms which carry operative tools and a third surgical robotic arm carrying a navigation camera, in accordance with some embodiments.

[0029] FIG. 2 is a side view illustrating a combination stabilization-shielding tool incorporating the disclosed technologies, in accordance with some embodiments.Atorney Docket No. 67551-721601; P403074WO

[0030] FIG. 3 is a perspective view illustrates the combination stabilization-shielding tool of FIG. 2 with a tool holder, in accordance with some embodiments.

[0031] FIG. 4 illustrates the combination stabilization-shielding tool of FIGS. 2 and 3 as used in a method according to the disclosed technologies, in accordance with some embodiments.DETAILED DESCRIPTION

[0032] With reference now to the figures and several representative embodiments of the disclosure, the following detailed description is provided.

[0033] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs.

[0034] As used herein, the singular forms “a,” “an,” and “the” include plural references unless the context clearly dictates otherwise. Any reference to “or” herein is intended to encompass “and / or” unless otherwise stated.

[0035] As used herein, the term “about” in some cases refers to an amount that is approximately the stated amount.

[0036] As used herein, the term “about” refers to an amount that is near the stated amount by 10%, 5%, or 1%, including increments therein.

[0037] As used herein, the term “about” in reference to a percentage refers to an amount that is greater or less the stated percentage by 10%, 5%, or 1%, including increments therein.

[0038] As used herein, 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 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” 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.

[0039] An exemplary robotic surgical system 10 suitable for use with the stabilizing members and methods of the disclosed technology is shown in FIG. 1. The robotic surgical system 10 comprises a chassis 12, typically a single, rigid frame, which provides a base or platform for three robotic arms 20, 22 and 24 that are placed relatively far apart on opposite longitudinal ends 14 and 16 of an upper surface 18 of the chassis 12, typically approximately one meter apart, thus allowing for desirable attributes such as reachability, maneuverability, and an ability to apply significant force. In the illustrated embodiment, robotic surgical arm 20 is on the first end 14 of the chassis 12 and robotic surgical arms 22 and 24 are on the second end 16 of the chassis. TheAttorney Docket No. 67551-721601; P403074WO chassis is often but not necessarily a mobile, e.g. being in the form of a mobile cart as described in commonly owned WO2022 / 195460, previously incorporated herein by reference. In other embodiments and implementations, the surgical arms 20, 22 and 24 could be mounted on a base or other structure of a surgical table. Placement of the robotic surgical arms on a common, stable platform allows the arms to be moved kinematically or otherwise within a common robotic coordinate system under the control of a surgical robotic controller, typically an on-board controller (not shown) having a user interface, such as display screen. Alternatively, the controller could be located at a remote workstation.

[0040] The single, rigid chassis of the disclosed technology will usually comprise, consist of, or consist essentially of a single mobile cart, as disclosed for example in commonly owned WO2022 / 195460, the full disclosure of which has been previously incorporated herein by reference. In other instances, however, the single, rigid chassis may comprise separate modules, platforms, or components, that are assembled at or near the surgical table, as described for example in commonly owned PCT Application PCT / EP2024 / 052353, entitled Integrated MultiArm Mobile Surgical Robotic System, filed on January 29, 2024, the full disclosure of which is incorporated herein by reference. The only requirement of the single, rigid chassis is that it provide a stable base for all the surgical arms so that they may be accurately and precisely kinematically positioned and tracked by the surgical robotic controller in a single surgical robotic coordinate space.

[0041] The chassis 12 of the robotic surgical system 10 is optionally configured to be temporarily placed under a surgical table 26 when performing the robotic surgical procedure, allowing the robotic surgical system 10 to be stored remotely before and after the procedure. The robotic arms 20, 22, and 24 may optionally be configured to be retracted into the chassis 12 of the robotic surgical system, allowing the system to be moved into or out of the surgical field in a compact configuration.

[0042] The robotic surgical arms 20, 22 and 24 are typically “multilink” structures with arms 20 and 22 having flanges 30 and 32 which are configured to hold tools, tool holders, flanges, end effectors, or the like, depending on the specific construction of the robot arm. For simplicity of explanation, FIG. 1 illustrates these components as flanges 30 and 32 of the robotic arms 20 and 22 which directly hold grinding tools 40 and 42. In other embodiments, not illustrated, grinders or other surgical tools could be held by tool holders as described, for example, in commonly owned PCT Publication W02025 / 008416 (Application PCT / EP2024 / 068766), filed on July 4,Atorney Docket No. 67551-721601; P403074WO2024, entitled MECHANICAL GEARBOX FOR ROBOTIC APPLICATIONS, the full disclosure of which is incorporated herein by reference. In place of or in addition to the tool holders, flanges (not illustrated) could be mounted at the distal links of either or both robotic surgical arms 20 and 22. Such flanges could contain electronics and other sensitive system components that cannot be sterilized under harsh condition. The third surgical robotic arm 24 will typically carry a navigation camera 34 or other sensor for monitoring the robotic surgical space.

[0043] While the exemplary mobile chassis 12 shown in FIG. 1 is intended to be deployed beneath a surgical table (not shown), the tool stabilization and shielding technologies disclosed and claimed hereinafter can also be incorporated into non-mobile surgical robots, such as those incorporated into a surgical table frame, as well as mobile surgical robotic carts and chasses which are not configured to extend beneath a surgical table. For example, surgical robotic carts and chasses incorporating the disclosed technologies can be configured to be deployed adjacent to a side, head, and / or foot of a surgical bed.

[0044] An exemplary stabilization and tissue protection tool 100 incorporating the disclosed technologies is illustrated in FIG. 2. The tool 100 comprises a tool hub 102 which is attached to a tool shaft 103 and a tool driver 104. A stabilizing element 107 having a distal tip 106 projects coaxially from a distal end 105 of the tool shaft 103. A shielding assembly 108, which carries a shielding element 109, extends laterally from a side of the shaft 103.

[0045] The shielding element 109 includes a proximal tubular section 110 and a distal trough section 112, and the shielding assembly 108 further comprises a first link 114 and a second link 116. The first link 114 is joined to the shaft 103 by a pivotal connector 120 and a distal end of the second link 116 is joined to the shielding element 109 by a connector 124. The inner, adjacent ends of the first link 114 and the second leak 116 are joined by a universal joint 122, thus allowing up to six degrees of motion between the shaft 104 and the shielding element 109, depending on the particular construction of each of the connectors. Although not shown, the connectors and joints 120, 122, and 124 will usually be motorized and powered so that the shielding assembly 108 can selectively position the shielding element 109, typically under the control of the surgical robotic controller (not shown).

[0046] Referring now to FIG. 3, the stabilization and tissue protection tool 100 may be configured to be mounted in a robotic surgical tool holder 150, such as the tool holder described in commonly owned PCT Publication W02025 / 008416 (Application No. EP2024 / 068766), filedAtorney Docket No. 67551-721601; P403074WO on July 4, 2024, entitled MECHANICAL GEARBOX FOR ROBOTIC APPLICATIONS, the full disclosure of which has been incorporated herein by reference. The surgical tool holder 150 comprises a housing 152 having a base 154 and an input drive member 156 on the base. The base 154 and input drive member 156 are configured to be removably (detachably) attached to an interface, such as flange 30 or 32, at the distal end of robotic surgical arm 20 or 22, as shown in FIG. 1. The input drive member 156 is configured to be coupled to an output drive member (not shown) disposed on the flange 30 or 32 when the tool holder 150 is mounted on the robotic surgical arm. The output drive member is typically powered, driven and controlled by the surgical robot, usually but not necessarily being driven by a motor mounted in the flange. A mechanical drive train is disposed in the housing 152 and is configured to selective drive both a gripper mechanism and a tool driver mechanism, as described in more detail in PCT / EP2024 / 068766, previously incorporated herein by reference.

[0047] A tool-receiving opening 158, typically having a gap 160 along one side thereof, is formed in an upper surface and near a distal end of the tool holder 150, and a separate tool driver port 162 is also formed on the upper surface of the tool holder and typically disposed a short distance proximally of the tool receiving opening 108. The tool-receiving opening 158 is configured to receive the tool driver 106 of the stabilization and tissue protection tool 100.

[0048] Referring now to FIG. 4, use of the stabilization and tissue protection tool 100 while milling bone in a patient's vertebra V using a surgical grinder 200 will be described. The surgical grinder 200 will be held in an operative tool holder 190, similar to the tool holder 150 described previously, while the stabilization and tissue protection tool 100 is used to locate the shielding element 109 of the shielding assembly 108 adjacent “sensitive tissue,” e.g., the patient's spinal cord SC. The distal tip 106 of the stabilizing element 107 engages a location on the same vertebra V (or in some cases an adjacent vertebra) to inhibit displacement of the vertebra during the milling procedure. The distal tip 106 will often be sharpened or threaded to penetrate the bone surface to enhance the grip and stabilizing effect.Atorney Docket No. 67551-721601; P403074WO

[0049] List of Reference Numbers.Atorney Docket No. 67551-721601; P403074WO

[0050] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the disclosure. It should be understood that various alternatives to the embodiments of the disclosure described herein may be employed in practicing the disclosure. One of skill in the art will realize that several variations on the disclosed embodiments are possible while staying within the bounds of the current disclosure. Solely by way of example, different variations in the number of navigation cameras, robotic arms, markers and end effectors can be used without departing from the current disclosure. As another example, markers of varying sizes can be used. The embodiments provided are representative in nature.

Claims

Atorney Docket No. 67551-721601; P403074WOCLAIMSWHAT IS CLAIMED IS:

1. A method for performing a robotic surgical procedure at a target location on a patient’s anatomy adjacent to sensitive tissue, the method comprising: mounting a combination stabilization-shielding tool on a first surgical robot arm; mounting an operative surgical tool on a second surgical robot arm; positioning the first surgical robot arm to engage a stabilizing element of the combination stabilization-shielding tool against a stabilizing location on the patient’s anatomy and locate a shielding element of the combination stabilization-shielding tool between the target location on the patient’s bony anatomy and the sensitive tissue; positioning a second surgical robot arm to place the operative surgical tool at the target location; performing the robotic surgical procedure at the target location with the operative surgical tool while the stabilizing element remains engaged with the stabilizing location on the patient’s bony anatomy and the shielding element remains positioned between the target location on the patient’s anatomy and the sensitive tissue.

2. The method of claim 1 , wherein the stabilizing element penetrates a bony anatomy.

3. The method of claim 1, wherein the stabilizing element engages a bony or other anatomy without penetration.

4. The method of any one of claims 1 to 3, wherein the operative procedure comprises one or more of decompression, laminectomy, drilling, grinding, distraction, or screwing.

5. The method of any one of claims 1 to 4, wherein the first procedure comprises placing an implant.

6. The robotic method of any one of claims 1 to 5, wherein the target and stabilizing locations are in a single vertebra.

7. The robotic method of any one of claims 1 to 5, wherein the target and stabilizing locations are in separate vertebra.Atorney Docket No. 67551-721601; P403074WO8. A combination stabilization-shielding tool configured for use with a surgical robot, the tool comprising: a structure configured to be held by an arm of the surgical robot, the structure comprising; a stabilizing element configured to be engaged against a stabilizing location on a patient’s anatomy; and a shielding element configured to be positioned between a target location on the patient’s anatomy and a sensitive tissue location adjacent to the target location when the stabilizing element is engaged against the stabilizing location.

9. The combination stabilization-shielding tool of claim 8, wherein the structure is configured to be held by a tool holder mounted on a distal end of the surgical robot arm.

10. The combination stabilization-shielding tool of claim 8 or 9, wherein the stabilizing element and the shielding element are repositionable relative to each other.

11. The combination stabilization-shielding tool of claim 10, wherein the stabilizing element and the shielding element are manually repositionable.

12. The combination stabilization-shielding tool of claim 10, further comprising a motor configured to reposition the stabilizing element relative to the shielding element.

13. The combination stabilization-shielding tool of any one of claims 8 to 12, wherein the stabilizing element comprises a shaft having a distal end configured to engage the stabilizing location on the patient’s anatomy.

14. The combination stabilization-shielding tool of claim 13, wherein the shaft is configured to be removably positioned in a gripper of a tool holder.

15. The combination stabilization-shielding tool of any one of claims 8 to 14, wherein the shielding element comprises a semi-cylindrical barrier having an open trough for receiving a milling tool.

16. The combination stabilization-shielding tool of any one of claims 8 to 15, wherein the stabilizing element and the shielding element are joined by an adjustable mechanical linkage.

17. The combination stabilization-shielding tool of any one of claims 8 to 16, wherein the stabilizing element is configured to be engaged against the stabilizing location on the patient’s anatomy.Atorney Docket No. 67551-721601; P403074WO18. The combination stabilization-shielding tool of any one of claims 8 to 16, wherein the stabilizing element is configured to penetrate the stabilizing location on the patient’s anatomy.

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