Patent Description:
A technique commonly referred to as spinal fixation is employed for fusing together and/or mechanically immobilizing vertebrae of the spine. Spinal fixation may also be used to alter the alignment of adjacent vertebrae relative to one another so as to change the overall alignment of the spine. Such techniques have been used effectively to treat many degenerative conditions and, in most cases, to relive pain suffered by the patient.

In some applications, a surgeon will install implants, such as pedicle screws, into the pedicles of adj acent vertebrae (along one or multiple levels of the spine) and thereafter connect the screws with a spinal rod in order to immobilize and stabilize the vertebral column. Whether conducted in conjunction with interbody fusion or across single or multiple levels of the spine, the use of pedicle screws connected by fixation rods is an important treatment method employed by surgeons.

Prior to implantation of the implant, a surgeon or other medical professional must first make an incision through the soft tissue to access the pedicle screw implant location. This access allows for the cutting tool, e.g. drill or burr, to access the bone where the hole will be drilled. However, the cutting tool may be deflected away from the desired trajectory by cantilever forces from the soft tissue. This may contribute to inaccurate and/or inefficient placement of the implant.

Document <CIT> discloses a surgical knife blade for forming an incision in bodily tissue comprising a body having a cutting edge terminating at a distal tip, said cutting edge including opposing cutting edge segments extending distally to meet at said tip, said cutting edge being configured by blending a first and second radii. Documents <CIT>, <CIT>, <CIT> and <CIT> disclose various other blade designs for a surgical incision tool.

Documents <CIT> and <CIT> disclose surgical robotic systems with robotic end effectors to which surgical tools can be attached.

There remains room for improvement in the design and use of incision tools particularly for surgical efficiency while maintaining safety and accuracy during implant insertion.

The invention is disclosed in claim <NUM>, dependent claims disclosing preferred embodiments of the invention.

The present disclosure includes a system for surgery which provides accurate and efficient placement of an implant during surgery, such as spinal surgery. In some instances, the system includes an insertion tool may be used in spinal surgery in order to make an incision through the soft tissue to allow for access to the pedicle bone. The system allows for trajectory alignment of the incision and the subsequent drilling tool and also may allow for rotational alignment so that the orientation of the incision is controlled, as desired.

According to a first aspect of the present disclosure, a tool for creating an incision at a surgical site includes a body for use with a robotic end effector having a proximal end and a distal end, and a blade positioned at the distal end of the body, the blade having a proximal end and a distal end, the blade having a cutting edge defining a first portion extending outwardly from or adjacent to the proximal end to a maximum width and a second portion extending inwardly from the maximum width to a sharp distal tip.

In other aspects, the first portion may be convex. The second portion may be convex. The second portion may have a first side having a convex curve and a second side may have a concave curve. The blade may be detachable from the body. The distal end of the body may include an elongated projection and the blade includes a corresponding elongated recess for receiving the elongated projection of the body to attach the blade to the body. The blade may have a longitudinal axis extending along a direction from the proximal end to the distal end and the cutting portion of the blade is symmetric about the longitudinal axis. The blade may have a longitudinal axis extending along a direction from the proximal end to the distal end and the cutting portion of the blade is asymmetric about the longitudinal axis. The proximal portion of the body may have a C-shaped cross-section. A proximal portion of the body may have an attachment assembly to detachably secure the tool to the end effector. The attachment assembly may be a clip assembly including a spring-loaded leaf. The clip assembly may include a base having a first flange and the leaf has a second flange. An opening may be defined between the base and the leaf, wherein the clip assembly is moveable between a closed configuration and an open configuration and the opening is larger in the open configuration than in the closed configuration. The tool may be a first tool and in the closed configuration, a second tool is positionable within the first tool and the first tool is operatively secured to the end effector. The attachment assembly may be a hinged assembly including a hinged leaf. The tool may be part of a system that includes the tool and a guide tube attachable to a robotic arm, the tool may be configured to be positioned within the guide tube.

According to a second aspect of the present disclosure, a system for incising an opening in a patient includes a first tool having a first longitudinal axis and engageable with a robotic end effector, an incision tool having a body defining a channel for receiving the first tool and a distal portion, and a blade attached to the distal portion of the body of the incision tool, a first central axis defined by the channel of the incision tool is co-axial with a second central axis defined by the blade.

In other aspects, a proximal portion of the body of the incision tool may have a C-shaped cross-section. The incision tool may be configured to translate relative to the first tool along the first central axis. The blade may have a proximal end and a distal end, the blade having a cutting edge defining a first portion extending outwardly from or adjacent to the proximal end to a maximum width and a second portion extending inwardly from the maximum width to a sharp distal tip. The incision tool may include a finger ring for holding the incision tool. The incision tool may be configured to clip onto the first tool to attach the incision tool to the first tool. The body may include a proximal portion at least partially surrounding the channel, the proximal portion sized and configured to fit around an outer diameter of the first tool. The body of the incision tool may include a hinged attachment member having a closed configuration in which the hinged attachment member presses on the first tool to secure the incision tool to the first tool. The first tool may be a drill bit, screwdriver, or burr. The system may include an implant configured to be attached to a distal end of the first tool.

According to another aspect of the present disclosure, a method of incising an opening in a subject includes the steps of attaching an incision tool to a first tool so that a proximal portion of the incision tool at least partially surrounds a portion of the first tool, the incision tool having a blade attached to a distal end thereof, a central axis of the blade being co-axial with a longitudinal axis of the first tool; driving the incision tool along the first tool to cut tissue with the blade to incise an opening for inserting an implant; and retracting the blade out of the opening.

In other aspects, the method may include the step of driving the first tool into the opening to form a bore for receiving an implant. The driving step may include translating the incision tool distally along an outer surface of the first tool. The method may include the step of attaching the blade to a distal end of the incision tool. The method may include the step of moving an attachment assembly of the incision tool to a closed configuration in which a leaf of the hinged assembly applies a force on the first tool to secure the incision tool to the incision tool. The method may include the step of moving the attachment assembly of the incision tool to an open configuration in which the incision tool is detached from the first tool. The first tool may be a screwdriver and an implant may be attached to a distal end of the screwdriver. The method may include the step of driving the implant into bone.

According to yet another aspect of the present disclosure, a method of incising an opening in a subject includes the steps of positioning a first portion of an incision tool within a robotic end effector, and advancing the incision tool distally so that a blade attached to a distal end of the incision tool cuts into tissue along a first trajectory. The method may include the step of removing the incision tool from the robotic end effector. The method may include the steps of positioning a cutting tool within the robotic end effector and advancing the cutting tool into bone along the first trajectory. The cutting tool may be a drill bit. The end effector may include a guide tube configured to receive the incision tool. Methods of incising tissue of a subject do not form part of the present invention.

The present disclosure generally relates to incision tools and blades able to be used in conjunction with such incision tools for incision of a subject along an accurate trajectory, particularly during spinal surgery. Those of skill in the art will recognize that the following description is merely illustrative of the principles of the disclosure, which may be applied in various ways to provide many different alternative aspects. <FIG> and <FIG> show embodiments in accordance with the claimed invention.

In describing certain aspects of the present disclosures, specific terminology will be used for the sake of clarity. However, the disclosures are not intended to be limited to any specific terms used herein, and it is to be understood that each specific term includes all technical equivalents, which operate in a similar manner to accomplish a similar purpose. In the drawings and in the description which follows, the term "proximal" refers to the end of the fixation members and instrumentation, or portion thereof, which is closest to the operator in use, while the term "distal" refers to the end of the fixation members and instrumentation, or portion thereof, which is farthest from the operator in use.

The various aspects of the tools described below are designed to facilitate efficient and accurate implant insertion during surgery. <FIG> depict a first aspect of an incision system <NUM> including an incision tool <NUM> and a blade <NUM>. Blade <NUM> is designed to removably attach to distal end <NUM> of incision tool <NUM>.

Incision tool <NUM> extends along a longitudinal axis from distal end <NUM> to proximal end <NUM> and includes proximal shaft <NUM> and distal shaft <NUM>. Controlling diameter <NUM> connects proximal shaft <NUM> to distal shaft <NUM>. In the illustrated aspect, proximal shaft <NUM> has a circular cross-sectional shape while distal shaft <NUM> has a non-circular cross-sectional shape. Proximal shaft <NUM> is designed to be passed through end effector <NUM> to mate with controlling diameter <NUM> such that the end effector is capable of translating incision tool <NUM> along the haptic line when the incision tool is received within the robotic end effector <NUM>, as described in further detail below. Proximal shaft <NUM> includes aperture <NUM> for receiving a corresponding protrusion feature to enable quick connecting of a modular handle <NUM>.

Distal shaft <NUM> includes first portion <NUM> and second portion <NUM> which forms the distal end of incision tool <NUM>. Second portion <NUM> has a relatively smaller diameter than first portion <NUM>, such that shoulder <NUM> is formed at the transitional point between the first and second portions. Second portion <NUM> is an attachment portion that forms a quick connect feature with blade <NUM> such that the blade attaches to the distal end of incision tool <NUM>. The details of the connection are described in further detail below.

Blade <NUM> generally has a spade-like shape, as shown in <FIG> and best shown in <FIG>. Blade <NUM> includes distal end <NUM> and proximal end <NUM>. Proximal end <NUM> includes terminating edge <NUM> connecting two lateral sides <NUM>. Terminating edge <NUM> extends along a nonperpendicular angle with respect to a longitudinal axis of the blade, the longitudinal axis extending along the proximal to distal direction while sides <NUM> extend in a direction substantially parallel to the longitudinal axis. Although in other aspects, sides <NUM> may be non-parallel to the longitudinal axis and the terminating edge <NUM> may be extend substantially perpendicular to the longitudinal axis. Blade <NUM> includes front cutting edge <NUM>, e.g. when moving in the distal direction and/or toward the tissue, and rear cutting edge <NUM>, e.g. when moving in the proximal direction and/or retracting from the bone. Rear cutting edge <NUM> extend from sides <NUM> and flare outward to hips <NUM> that define the widest diameter of the blade, defined in a direction transverse to the longitudinal axis of the blade. Hips <NUM> extend inward distally to define front cutting edge <NUM> which extends to a sharp distal tip <NUM>. In this example, rear cutting edge <NUM> is convex to hips <NUM> and front cutting edge <NUM> is concave from hips <NUM> to distal tip <NUM>.

Blade <NUM> includes substantially planar upper and lower surfaces <NUM>, <NUM>. Blade <NUM> defines elongated aperture <NUM> that is elongated in the direction of the longitudinal axis of the blade. Elongated aperture <NUM> is designed to allow a portion of distal shaft <NUM> of incision tool <NUM> to fit, by for example an interference fit, within the elongated aperture. In this regard, second portion <NUM> of distal shaft <NUM> includes raised portion <NUM> and a depressed portion <NUM>, which is in the form of a channel extending across the width of second portion <NUM> and defined by opposing axially spaced apart inner surfaces <NUM>.

Incision tool <NUM> is designed to be used in conjunction with blades previously known in the art other than the novel blades disclosed herein. For example, <FIG> shows incision tool <NUM> with blade <NUM> connected to the second portion <NUM> of distal shaft <NUM> via a connection between elongated aperture <NUM> and raised portion <NUM>. Alternative blades that may be used with the incision tools of the present disclosure are disclosed in <CIT>.

Incision tool <NUM> may be used with robotic systems during spinal surgery. Robotic systems such as robotic device <NUM> may be used throughout the pre-operative and intra-operative stages of the surgery. Preoperative planning for surgeries may include determining the bone quality in order to optimize bone preparation. Bone quality information, such as bone density or elastic modulus, can be ascertained from preoperative scans, e.g. CT scans. The bone quality data can be used to determine optimal properties for effective implant engagement. Examples of such methods are found in <CIT>, entitled "Patient Specific Bone Preparation for Consistent Effective Fixation Feature Engagement," <CIT>, entitled "Implant Design Using Heterogeneous Bone Properties and Probabilistic Tools to Determine Optimal Geometries for Fixation Features," and <CIT>, entitled "Implant Placement Planning". In addition to preoperative imaging, robotic surgery techniques may employ imaging, such as fluoroscopy, during surgery. In such cases, systems integrating the surgical system with the imaging technologies facilitate flexible and efficient intraoperative imaging. Exemplary systems are described in <CIT>, entitled "System for Image-Based Robotic Surgery".

Robotic systems and methods may be used in the performance of spine surgeries. In some such instances, robotic systems and methods may be used in the performance of spine surgeries to facilitate the insertion of implants in the patient's spine as in, for example, <CIT>, entitled "Robotic Spine Surgery System and Methods". The robotic system generally includes a manipulator and a navigation system to track a surgical tool relative to a patient's spine. The surgical tool may be manually and/or autonomously controlled. Examples of robotic systems and methods that employ both a manual and a semi-autonomous are described in <CIT>, and entitled "Robotic System and Method for Transitioning Between Operating Modes," and <CIT>, entitled "Surgical Manipulator Capable of Controlling a Surgical Instrument in Multiple Modes".

A robotic controller may be configured to control the robotic arm to provide haptic feedback to the user via the robotic arm. This haptic feedback helps to constrain or inhibit the surgeon from manually moving the incision tool beyond predefined virtual boundaries associated with the surgical procedure. Such a haptic feedback system and associated haptic objects that define the virtual boundaries are described in, for example, <CIT>, entitled "Haptic Guidance System and Method," and <CIT>, entitled "Systems and Methods for Haptic Control of a Surgical Tool," and <CIT>, entitled "System and Method for Manipulating an Anatomy".

In some cases of autonomous positioning, a tool center point (TCP) of a surgical tool, such as incision tools <NUM>, <NUM>, is brought to within a predefined distance of a starting point of a line haptic object that provides the desired trajectory. Once the tool center point is within the predefined distance of the starting point, actuation of an input causes the robotic arm to autonomously align and position the surgical tool on the desired trajectory. Once the surgical tool is in the desired position, the robotic system may effectively hold the rotational axis of the surgical tool on the desired trajectory by tracking movement of the patient and autonomously adjusting the robotic arm as needed to keep the rotational axis on the desired trajectory. Such teachings can be found in <CIT>, entitled "Systems and Methods for Haptic Control of a Surgical Tool".

During operation of a robotic surgical system, the operation of the surgical tool can be modified based on comparing actual and commanded states of the tool relative to the surgical site is described in <CIT>, entitled Techniques for Modifying Tool Operation in a Surgical Robotic System Based on Comparing Actual and Commanded States of the Tool Relative to a Surgical Site". Further, robotic systems may be designed to respond to external forces applied to it during surgery, as described in <CIT>, entitled "Robotic System and Method for Backdriving the Same".

Further, because of the non-homogeneity of bone, applying a constant feed rate, a uniform tool path, and a constant rotational speed may not be efficient for all portions of bone. Systems and methods for controlling tools for such non-homogenous bone can be advantageous as described in <CIT>, entitled "Robotic Systems and Methods for Controlling a Tool Removing Material From a Workpiece".

<FIG> and <FIG> show incision tool <NUM> in use with robotic device <NUM> including robotic end effector <NUM> into which proximal end <NUM> is positioned and attached via the attachment feature, such as the one discussed above. During use of robotic device <NUM> of the present disclosure, the robotic end effector <NUM> may be moved into a haptic control trajectory or positioned along a predetermined static trajectory. Incision tool <NUM> and distal tip <NUM> of blade <NUM> are coaxial with the longitudinal axis of the opening of the robotic end effector. As robotic end effector <NUM> is positioned near the target location, sharp distal tip <NUM> punctures the tissue to create the initial opening within the tissue.

When blade <NUM> rather than blade <NUM> is used with incision tool <NUM> and robotic end effector <NUM>, front cutting edge <NUM> cuts through the tissue as the blade is advanced distally. Once the blade is advanced to meet the bone, or a desired depth within the soft tissue, the blade <NUM> can be retracted along the same trajectory, e.g. haptic control trajectory or predetermined static trajectory. Rear cutting edge <NUM> cuts any tissue that crept over the entry incision. This allows the incision and dissection to be completed in one pass along the trajectory of the robotic end effector resulting in efficiently producing an incision that is the desired width and depth as well as orientation. Further, the fewer passes that an incision tool makes, the less opportunity for skiving to occur which reduces the likelihood of an inaccurate trajectory. Additionally, the coaxial nature of the incision and the robot guided trajectory creates a soft tissue envelop that is coaxial to the planned screw trajectory which reduces the soft tissue forces and reduces the potential for skiving.

Further, robotic end effector <NUM> can be advanced to a position which is a fixed distance from the soft tissue surface. This helps to assess the tissue depth, maintain tactile feedback, and reduce the likelihood of inadvertent advancement of the robotic end effector while sliding the incision tools of the present disclosure along an instrument.

<FIG> show incision system <NUM> which includes incision tool <NUM> and blade <NUM>, identical to blade <NUM>. Incision tool <NUM> includes many similar features as incision tool <NUM>, with similar features sharing the same reference numeral, although represented in the <NUM> series.

Incision tool <NUM> is designed to be used with an instrument and/or implant and robotic device <NUM>, as shown in <FIG>. An instrument, shown as drill bit <NUM>, can be inserted within and engaged with robotic end effector <NUM> such that the drill bit <NUM> extends distally from end effector <NUM> along a longitudinal axis of the drill bit. Incision tool <NUM> has a generally C-shaped cross-section to surround a portion of the instrument or drill bit <NUM> to releasably attach the incision tool <NUM> to the drill bit <NUM>. Incision tool <NUM> hugs an outer diameter of the drill bit <NUM>, and with a surgeon manually holding the incision tool <NUM> to the drill bit <NUM>, the incision tool can be translated both distally and proximally along outer surface <NUM> of drill bit <NUM>, as discussed in greater detail below, and can be positioned on the drill bit <NUM> in the desired orientation, e.g. vertical or horizontal, to allow the surgeon to choose the orientation of the incision based on the anatomy.

Incision tool <NUM> includes body <NUM> extending along a longitudinal axis. Body <NUM> includes a proximal portion <NUM> and a distal end, which includes attachment portion <NUM> substantially identical to second portion <NUM> of incision tool <NUM> which allows for a quick connection between the incision tool and a blade. Body <NUM> includes opposing exterior surface <NUM> and interior surface <NUM> each extending from the proximal portion to the distal portion. Interior surface <NUM> is generally concave along proximal portion <NUM> and first portion <NUM> of distal portion <NUM> to form valley <NUM>, shown in <FIG>. Interior surface <NUM> is generally smooth, while a portion of exterior surface includes raised bars <NUM> evenly spaced apart and extending in a direction transverse to the longitudinal axis of body <NUM>. Raised bars <NUM> provide for a better grip on the device.

Proximal portion <NUM> of body <NUM> is generally C-shaped such that the widest diameter of the proximal portion, in a direction transverse to the longitudinal axis, is spaced apart from the terminal edges <NUM>, as the terminal edges curl slightly back radially inwardly. <FIG> shows the arc shaped cross-section of proximal portion <NUM>. Distal portion <NUM> may also be substantially C-shaped or it may alternatively be substantially U-shaped. Proximal portion <NUM> forms an opening or channel <NUM> such that drill bit <NUM> can occupy the passage when incision tool <NUM> is attached to the drill bit. The shape of the body allows for incision tool <NUM> to fit around drill bit <NUM> while still allowing the incision tool to translate relative to the instrument.

As shown in <FIG>, second portion <NUM> of distal portion <NUM> is not flush with valley <NUM> of body <NUM> extends further radially inward than the valley such that when blade <NUM> is attached to second portion <NUM> it too is positioned radially inward of valley <NUM> of body <NUM>. As a result, a central axis of blade <NUM> is positioned substantially co-axial with the central longitudinal axis of drill bit <NUM> when outer surface <NUM> is in contact with interior surface <NUM>, i.e. when incision tool <NUM> is assembled to drill bit <NUM>.

The incision tools described herein, including incision tool <NUM>, can be used in conjunction with a variety of blades, with quick attachment features provided at the distal ends of the incision tool. For example, <FIG> shows incision tool <NUM> with blade <NUM> attached to the distal end.

<FIG> show incision system <NUM> in use with robotic device <NUM> and drill bit <NUM>. Although shown with drill bit <NUM>, other similar instruments may be used in conjunction with incision tool <NUM>, such as a screwdriver and burr.

Drill bit <NUM> is loaded and secured within the robotic end effector <NUM>. Incision tool <NUM> is placed onto the drill bit such that the drill bit is positioned within passageway <NUM>. The surgeon can place incision tool <NUM> onto the drill bit in the desired orientation. A surgeon or other user manually slides incision tool <NUM> distally, shown in a comparison of <FIG> and <FIG>, to incise the tissue in a manner co-axial with the haptic control trajectory or predetermined static control trajectory set for the robotic device for which drill bit <NUM> is positioned along. The opening in tissue is incised in a single pass due to the front cutting edge and rear cutting edge of the blade, as described above. With drill bit <NUM> positioned against the opening and along the desired trajectory, incision tool <NUM> can be translated proximally and then detached from drill bit <NUM>. After tool <NUM> is removed, robotic end effector <NUM> can be actuated to torque drill bit <NUM> to drill along the trajectory of the incision.

<FIG> depict incision system <NUM> which includes incision tool <NUM> and blade <NUM>, in accordance with the claimed invention. Blade <NUM> is similar to blade <NUM> described above, except that front cutting edge <NUM> has a convex shape rather than the concave shape of front cutting edge <NUM>.

Incision tool <NUM> includes elongated body <NUM> including proximal portion <NUM> of body <NUM> which has a substantially C-shaped cross-section. Proximal portion <NUM> includes an attachment assembly for attaching the incision tool to another instrument for use during the surgery. In this embodiment, the attachment assembly includes hinged assembly <NUM>, which includes leaf <NUM> secured to elongated body <NUM> by pin <NUM> received within at least one knuckle <NUM>. Knuckle <NUM> curves radially outward from body <NUM> and leaf <NUM> curves radially back inward toward and extending over interior surface <NUM> of body <NUM> such that hinged assembly <NUM> of proximal portion <NUM> has a substantially C-shaped cross-section that drill bit <NUM> can be positioned within. Leaf <NUM> defines opening <NUM> for receiving pin <NUM> and the leaf is rotatable relative to pin <NUM>. Proximal portion <NUM> further defines opening <NUM>, shown in <FIG>, for receiving a tool, such as drill bit <NUM>. When drill bit <NUM> is positioned within opening <NUM> defined by proximal portion <NUM> of incision tool <NUM>, leaf <NUM> is movable from a first open configuration in which the drill bit is not engaged with and/or limited in movement by incision tool and a second closed configuration in which leaf <NUM> is moved relatively further radially inward to impart a clamping force on drill bit <NUM> to engage the drill bit that is positioned within the incision tool <NUM>. Leaf <NUM> is designed to allow a varying amount of force on drill bit <NUM> so that a surgeon has greater control on the positive connection between the drill bit and the incision tool which provides tactile feedback when the drill bit and the incision tool <NUM> are operatively coupled to one another.

Incision tool <NUM> further includes finger ring <NUM> disposed on exterior surface <NUM> and extending away from body <NUM>. Finger ring <NUM> allows a surgeon to grasp the ring while also maintaining pressure on leaf <NUM> to control the connection between incision tool <NUM> and drill bit <NUM>.

As shown in <FIG> and <FIG>, incision tool <NUM> includes attachment portion <NUM> at the distal end of the incision tool for attaching blade <NUM> to the incision tool. Attachment portion <NUM> is designed to easily and securely position blade <NUM> in engagement with incision tool <NUM>. Attachment portion <NUM> includes raised portion <NUM> which is positionable within elongated aperture <NUM> of blade <NUM>. Proximal to raised portion <NUM> is depressed portion or channel <NUM> extending across the width of attachment portion <NUM> and defined by opposing axially spaced apart inner surfaces <NUM>. Interior surface <NUM> of elongated body 520connects to attachment portion <NUM> at ski jump <NUM> which extends outwardly from interior surface <NUM> such that the attachment portion is raised relative to the interior surface <NUM> of the elongated body <NUM>, as shown in <FIG>.

When blade <NUM> is secured to attachment portion <NUM>, a central axis of the blade is co-axial with the central axis of the incision tool but is raised with respect to the plane on which the interior surface <NUM> extends, as shown in <FIG>. Further, when system <NUM> is assembled with cutting tool <NUM> positioned within incision tool <NUM>, blade <NUM> is co-axial with the central axis of the cutting tool, as shown in <FIG>, and <FIG>.

In use, blade <NUM> is attached to incision tool <NUM>. Drill bit <NUM> is loaded and secured within the robotic end effector <NUM>. Incision tool <NUM> is positioned with hinged assembly <NUM> in the open configuration and positioned around drill bit <NUM>. Leaf <NUM> of hinged assembly <NUM> is then moved radially inward into contact with drill bit <NUM> to engage the drill bit and provide an operative connection between the drill bit and the incision tool <NUM>. Incision tool <NUM> is then translated distally along drill bit <NUM> and driven through a patient's soft tissue to make an incision. Incision tool <NUM> is translated proximally and blade <NUM> retracted out of the skin. Hinged assembly <NUM> is moved to the open configuration to disconnect the incision tool from drill bit <NUM>. Drill bit <NUM> is then robotically powered to drill the opening that is in trajectory and/or rotational alignment with the incision for implanting the implant, e.g. screw. Although described with reference, to drill bit <NUM>, the method can also be employed using a screwdriver, burr, or other similar tool.

Turning to <FIG>, incision system <NUM> includes incision tool <NUM>, blade <NUM>, and screwdriver <NUM> with screw <NUM> for implanting into a spine according to another embodiment of the claimed invention. Incision tool <NUM> has many similar features as incision tool <NUM>, with similar features having the same reference numeral except in the <NUM> series. Incision tool <NUM> includes proximal portion <NUM> of body <NUM>, which includes attachment assembly in the form of spring-loaded clip assembly <NUM> for loading the incision tool onto screwdriver <NUM>.

Clip assembly <NUM> includes base <NUM> defined by opposing first and second lateral edges 622a and 622b. As shown in <FIG>, pin <NUM> is received within at least one knuckle <NUM> and at least partially surrounded by spring <NUM>. Spring <NUM> is positioned within recess <NUM> of proximal portion <NUM>, as shown in <FIG>. Base <NUM> includes first flange <NUM> extending outwardly from second lateral edge 622b and which forms part of the clip member. Leaf <NUM> is rotatably connected to pin <NUM> and includes inner edge 632a and second flange <NUM> extending outwardly from outer edge 632b of leaf <NUM>. Leaf <NUM> and base <NUM> define opening <NUM> therebetween for receiving screwdriver <NUM>.

First and second flanges <NUM>, <NUM> can be grasped by a surgeon to move the clip assembly <NUM>, and in particular to move second flange <NUM>, from a closed configuration in which inner edge 632a of leaf <NUM> is relatively closer to first lateral edge 622a of base <NUM> and an open configuration in which inner edge 632a of leaf <NUM> is relatively farther from first lateral edge 622a of base <NUM> which increases the size of opening <NUM>. Further, during the transition from the closed configuration to the open configuration, second flange <NUM> moves in a direction toward first flange <NUM>. Clip assembly <NUM> is biased such that at rest the assembly is in the closed configuration to hug an outer diameter of the screwdriver <NUM>.

Handle <NUM> is attached to proximal portion <NUM> and has a substantially tubular shape to allow for easy gripping by a surgeon. In the illustrated embodiment, handle includes a threaded end <NUM> to screw into threaded opening <NUM> within base <NUM>, which provides for detachment of the handle, if necessary.

Attachment portion <NUM> of incision tool <NUM> is substantially similar to attachment portion <NUM> of incision tool <NUM>, the details of which are described in detail above.

In use, screw <NUM> is inserted onto distal end <NUM> of screwdriver <NUM>, and screwdriver <NUM> is loaded into robotic end effector <NUM>, as shown in <FIG>. Incision tool <NUM> (with blade <NUM> attached), and in particular clip assembly <NUM>, is moved from the closed configuration to the open configuration to enlarge opening <NUM> so that screwdriver <NUM> fits within opening <NUM> and is by a surgeon pressing on first and second flanges <NUM>, <NUM> to move second flange <NUM> to the open configuration. Second flange <NUM> is then released to move the clip assembly <NUM> to the closed configuration such that the screwdriver <NUM> is positioned within the incision tool <NUM>, as shown in <FIG>.

The surgeon, or other medical professional, can then hold handle <NUM> to translate incision tool <NUM> distally, shown in <FIG>, to make an incision through the patient's tissue and subsequently retracted in a proximal direction along screwdriver <NUM> to create an incision that is formed in a single pass. The incision created within the patient is co-axial with the trajectory of the longitudinal axis that the screwdriver <NUM> and screw <NUM> extend along. Clip assembly <NUM> is transitioned into the open configuration to detach the incision tool <NUM> from the screwdriver <NUM>. The screwdriver is then actuated by the robotic end effector <NUM> to drive screw <NUM> into bone along the trajectory of the incision.

<FIG> show enlarged views of various aspects of single pass blades designed for easy attachment to any one of the incision tools described above. Such aspects are similar to blade <NUM>, shown in <FIG> and described in detail above with reference <FIG> and <FIG>; only the differences of each aspect will be described below.

<FIG> show blade <NUM> which is substantially spade shaped. Blade <NUM> includes distal end <NUM> and proximal end <NUM>. Proximal end <NUM> includes terminating edge <NUM> connecting two lateral sides <NUM>. Blade <NUM> includes front cutting edge <NUM>, e.g. when moving in the distal direction and/or into the tissue, and rear cutting edge <NUM>, e.g. when moving in the proximal direction and/or retracting from the bone. Rear cutting edge <NUM> extend from sides <NUM> and flare outward to hips <NUM> that define the maximum width of the blade, defined in a direction transverse to the longitudinal axis of the blade. Hips <NUM> extend inward distally to define front cutting edge <NUM> and extend to a concave sharp distal tip <NUM>. In this example, front cutting edge <NUM> is convex and rear cutting edge <NUM> is convex or linear. Blade <NUM> includes similar attachment features to attach the blade to the incision tools described herein.

<FIG> shows blade <NUM> which is substantially similar to blade <NUM>, except that distal tip <NUM> is relatively more rounded than distal tip <NUM> of blade <NUM>. <FIG> shows blade <NUM> which differs from blades <NUM> and <NUM> in that front cutting edge <NUM> is substantially linear, which may contribute to lower cutting forces and smoother insertion. <FIG> shows blade <NUM> which is asymmetrical about the longitudinal axis of the blade such that first portion 1064a of front cutting edge <NUM> is concave and second portion 1064b of front cutting edge <NUM> is convex. Second portion 1064b may provide a smoother cut while first portion 1064a provides a sharp tip.

<FIG> show incision system <NUM> according to another aspect of the present disclosure. Incision system <NUM> includes incision tool <NUM> configured to be received within end effector guide tube <NUM> attached to a robotic arm <NUM> of a robotic system and engageable with the end effector guide tube <NUM> to translate the incision tool to form an incision in the patient. System <NUM> is designed to facilitate the trajectory alignment of various tools during the surgery, including for example, the incision tool, the drill, and the screwdriver. Further, system <NUM> allows for rotational alignment of the various tools so that the orientation of the incision can be controlled based on the needs for the surgery. Each tool is designed to be positioned within the end effector guide tube <NUM>, which enables the trajectories or each tool to be the same relative to one another. For example, with incision tool <NUM> within the guide tube, the incision tool is able to be angulated to control the rotational orientation of the blade during incision.

As shown in <FIG>, incision tool <NUM> is sized and shaped to be positioned within end effector guide tube <NUM>. Incision tool <NUM> includes body <NUM> extending between proximal end <NUM> and distal end <NUM>. At proximal end <NUM>, body <NUM> includes handle <NUM> for a user to grip and control the tool. At distal end <NUM>, body <NUM> includes attachment portion <NUM> substantially similar to second portion <NUM> of incision tool <NUM>, and allows for a quick connection between the incision tool <NUM> and a blade. In the illustrated aspect, incision tool is shown in conjunction with blade <NUM>.

Body <NUM> includes central portion <NUM> between proximal end <NUM> and distal end <NUM> which is sized and configured to fit within guide tube <NUM> of the robotic system such that the central portion is able to translate axially and rotate freely within guide tube <NUM>. This enables the surgeon to be able to control the angulation of the incision tool <NUM> and blade <NUM> for the angle of insertion.

Guide tube <NUM> includes longitudinal slots <NUM>, shown in <FIG>, which allow for clearance for blade <NUM> as the blade passes through the guide tube <NUM>. After the blade is passed through the distal end of the guide tube, the system allows for control of the trajectory and angulation/rotation of the incision tool including blade <NUM>. Incision tool <NUM> may include a laser marking to indicate when the blade is in a certain position.

As shown in <FIG> and <FIG>, with blade <NUM> attached at the distal end <NUM>, incision tool <NUM> is positioned within end effector guide tube <NUM> of the robotic system. By allowing angulation and rotation of the incision tool <NUM> within guide tube <NUM>, the surgeon is able to control the orientation of the blade upon insertion. The incision tool makes an incision in the soft tissue via blade <NUM> along the desired trajectory. After the incision is made, incision tool <NUM> is removed by pulling it proximally, and the subsequent steps of surgery are performed with the respective tools travelling through the guide tube along the same desired trajectory for accurate and efficient placement of the implant, e.g. tapping, drilling, and driving the implant.

Claim 1:
A tool (<NUM>, <NUM>) for creating an incision at a surgical site comprising:
a body (<NUM>, <NUM>) for use with a robotic end effector (<NUM>) having a proximal end and a distal end; and
a blade (<NUM>, <NUM>) positioned at the distal end of the body (<NUM>, <NUM>), the blade (<NUM>, <NUM>) having a proximal end and a distal end, the blade (<NUM>, <NUM>) having a cutting edge defining a first portion extending outwardly from or adjacent to the proximal end to a maximum width and a second portion extending inwardly from the maximum width to a sharp distal tip,
wherein a proximal portion (<NUM>, <NUM>) of the body (<NUM>, <NUM>) has an attachment assembly (<NUM>, <NUM>) ) to detachably secure the tool (<NUM>, <NUM>) to the end effector (<NUM>),
characterized in that:
the attachment assembly is a clip assembly (<NUM>) including a spring-loaded leaf (<NUM>) or a hinged assembly (<NUM>) including a hinged leaf (<NUM>).