Patent Description:
The present invention relates to surgical systems; and more particularly, to a surgical sensor anchor system for use in surgical procedures utilizing robotic devices, the system having one or more components for housing a sensor, a sensor anchor, and one or more tools for anchor or sensor delivery.

Surgical procedures, such as those performed on the spine, are well known in the art. The central nervous system is a vital part of the human physiology that coordinates human activity. It is primarily made up of the brain and the spinal cord. The spinal cord is made up of a bundle of nerve tissue which originates in the brain and branches out to various parts of the body, acting as a conduit to communicate neuronal signals from the brain to the rest of the body, including motor control and sensations. Protecting the spinal cord is the spinal, or vertebral, column. Anatomically, the spinal column is made up of several regions, including the cervical, thoracic, lumbar and sacral regions. Each of the vertebrae associated with the various spinal cord regions are made up of a vertebral body, a posterior arch, and transverse processes.

While most people have fully functional spinal cords, it is not uncommon for individuals to suffer some type of spinal ailment or disorder which requires some type of surgical intervention. There are many different approaches taken to alleviate or minimize severe spinal disorders. One surgical procedure commonly used is a spinal fusion technique. Several surgical approaches have been developed over the years, and include the Posterior Lumbar Interbody Fusion (PLIF) procedure which utilizes a posterior approach to access the patient's vertebrae or disc space, the Transforaminal Lumbar Interbody Fusion (TLIF) procedure which utilizes a posterior and lateral approach to access the patient's vertebrae or disc space, and the Anterior Lumbar Interbody Fusion (ALIF) which utilizes an anterior approach to access the patient's vertebrae or disc space. Using any of these surgical procedures, the patient undergoes spinal fusion surgery in which two or more vertebrae are linked or fused together through the use of a bone spacing device and/or use of bone grafts. The resulting surgery eliminates any movement between the spinal sections which have been fused together. In addition to the spinal implants or use of bone grafts, spinal fusion surgery often utilizes spinal instrumentation or surgical hardware, such as pedicle screws, plates, or spinal rods. Once the spinal spacers and/or bone grafts have been inserted, a surgeon places the pedicle screws into a portion of the spinal vertebrae and attaches either rods or plates to the screws as a means for stabilization while the bones fuse. Currently available systems for inserting the rods into pedicle screws can be difficult to use, particularly in light of the fact that surgeons installing these rods often work in narrow surgical fields.

Moreover, since patients can vary with respect to their internal anatomy, resulting in varying curvatures of the spine, a surgeon may not always have a linear path, or may have anatomical structures that must be maneuvered around in order to properly insert the surgical rods into the pedicle screw assemblies. In addition to requiring surgical skill, difficulty in placing the rods correctly into the pedicle screws can result in unnecessary increases in the time it takes a surgeon to complete the surgical procedure. Prolonged surgery times increase the risk to the patient. More importantly, improperly aligning the rods and pedicle screw assemblies often results in post surgery complications for the patient and requires corrective surgical procedures.

Surgery is often required to repair broken skeletal components. Some bones are easier to put into place for healing than others. For example, a pelvis is plate like, having a large surface area for a given volume and, when broken, can have multiple fragments that need to be reassembled in place so that the bone fragments can grow back together. Skulls also have plate like configuration. This is unlike setting a femur or the like, since they typically do not fragment. Further, when a large surface area bone such as the pelvis or skull breaks into multiple fragments, it is difficult to determine where a particular fragment goes; and, if the trauma to the body is severe, the fragments can move about and not be in the same orientation they were in before breaking. Such breaking can occur in car accidents, falls and industrial accidents. It is left up to the skill of the surgeon to determine where a fragment goes and its orientation relative to other fragments. It is often difficult for a surgeon to hold these bone fragments in place to secure them in their proper orientation as with plates, screws, adhesives or the like. The more fragments, the more difficult the surgeon's job is. To further complicate such reconstruction, time spent doing the surgery should be as short as possible to help avoid surgical complications. Generally, the longer the surgical procedure, the higher the risk to the patient. Additionally, the more fragments, the more hands are needed to effect the reconstruction. The more human hands participating, the more difficult the surgery from a space standpoint.

In addition to requiring surgical skill, difficulty in placing the fragments can result in unnecessary increases in the time it takes a surgeon to perform the surgical procedure. Prolonged surgery times increase the risk to the patient. More importantly, improperly alignment of the fragments or placing them in an incorrect position can result in post-surgery complications for the patient and might require complex corrective surgical procedures later. Robotic surgery, computer-assisted surgery, and robotically-assisted surgery are terms for technological developments that use robotic systems to aid in surgical procedures. Robotically-assisted surgery was developed to overcome the limitations of pre-existing minimally-invasive surgical procedures and to enhance the capabilities of surgeons performing open surgery.

In the case of robotically-assisted minimally- invasive surgery, instead of directly moving the instruments, the surgeon uses one of two methods to control the instruments; either a direct telemanipulator or through computer control. A telemanipulator is a remote manipulator that allows the surgeon to perform the normal movements associated with the surgery while the robotic arms carry out those movements using end-effectors and manipulators to perform the actual surgery on the patient. In computer- controlled systems, the surgeon uses a computer to control the robotic arms and its end-effectors, though these systems can also still use telemanipulators for their input. One advantage of using the computerized method is that the surgeon does not have to be present, but can be anywhere in the world, leading to the possibility for remote surgery. One drawback relates to the lack of tactile feedback to the surgeon. Another drawback relates to visualization of the surgical site. Because the surgeon may be remote or the surgery may be percutaneous, is it difficult for the surgeon to view the surgery as precisely as may be needed.

In the case of enhanced open surgery, autonomous instruments (in familiar configurations) replace traditional steel tools, performing certain actions (such as rib spreading) with much smoother, feedback-controlled motions than could be achieved by a human hand. The main object of such smart instruments is to reduce or eliminate the tissue trauma traditionally associated with open surgery.

While robots are fully capable of repetitive tasks and work well in planned, routine settings, such environments are not always possible during a surgical procedure. In addition, robots are unintelligent in that they must be programmed to perform their functionality. However, this can be problematic when the environments they are programmed to function in are not static. As robotic systems become more prevalent in the surgical field, there exists a need for such robotic-assisted procedures to be performed safely and more intelligently, and capable of modifications in real time. <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, , <CIT> and <CIT> describe systems known in the art.

According to the invention it is provided a surgical sensor anchor system for use in surgical procedures utilizing robotic devices having the features of claim <NUM>. Further advantageous aspects of the invention are set forth in the dependent claims.

The present invention provides systems for use with robotically assisted surgery. The invention provides a surgical sensor anchor system for use in surgical procedures utilizing robotic devices. The disclosure further provides methods of performing a robotically assisted surgical procedure. The system and method utilizes a surgical sensor anchor having a sensor for use in tracking movement of at least one portion of a body structure undergoing a surgical procedure, or tracking movement of a body structure near a surgical site. The tracked movement can then be used to adjust directions of the robot in real time.

The present invention further provides systems for use with robotically assisted surgery. The invention provides a robotic system and surgical sensor anchor system for use in surgical procedures utilizing one or more robotic devices. The disclosure further describes but does not fall within the scope of the invention methods of performing a robotically assisted skeletal surgical procedure. The system and method can utilize a surgical sensor anchor having a sensor for use in tracking movement of at least one portion of a body structure undergoing a surgical procedure, effecting movement of a body structure near a surgical site and retaining it in a selected location for reconnection. The body structure movement can be manually controlled and/or robotically controlled in real time. The invention is particularly useful in orthopedic skeletal surgery.

Accordingly, it is an objective of the invention to provide a system for use with robotically assisted surgery.

It is an objective of the invention to provide a system for use with robotically assisted surgery where the robot can be used manually and with a controller.

There are described but do not fall within the scope of the invention methods for use with robotically assisted surgery.

It is yet another objective of the invention to provide a surgical sensor anchor system for use in surgical procedures utilizing robotic devices.

There are described but do not fall within the scope of the invention methods of performing a robotically assisted surgical procedure using one or more robots.

There are described but do not fall within the scope of the invention methods of performing a robotically assisted surgical procedure.

It is a further objective of the invention to provide a system that utilizes a surgical sensor anchor having a sensor for use in tracking movement of at least one portion of a body structure undergoing a surgical procedure or tracking movement of a body structure near a surgical site.

It is yet another objective of the invention to provide a system that utilizes tracked movement to adjust directions of the robot during a surgical procedure in real time.

There are described but do not fall within the scope of the invention a method of performing a robotically assisted surgical procedure that utilizes a surgical sensor anchor having a sensor for use in tracking movement of at least one portion of a body structure undergoing a surgical procedure or tracking movement of a body structure near a surgical site.

There are described but do not fall within the scope of the invention a a method of performing a robotically assisted surgical procedure that utilizes tracked movement to adjust directions of the robot during a surgical procedure in real time.

There are described but do not fall within the scope of the invention a redundant monitoring system that utilizes at least two types of fiducial markers.

There are described but do not fall within the scope of the invention a monitoring system that utilizes electromagnetic as well as optical sensors to monitor the position of a body structure.

There are described but do not fall within the scope of the invention a method of performing a robotically assisted surgical procedure that utilizes a surgical sensor anchor having a sensor for identifying a skeletal part and tracking movement of at least one portion of a skeletal part undergoing a surgical procedure.

There are described but do not fall within the scope of the invention a method of performing a robotically assisted surgical procedure that utilizes tracked movement and/or skeletal part orientation to adjust directions of the robot during a surgical procedure in real time.

There are described but do not fall within the scope of the invention a monitoring system that utilizes electromagnetic as well as optical sensors to monitor the position and orientation of a skeletal part relative to other skeletal parts.

There are described but do not fall within the scope of the invention a method to program a computer to control movements of one or more robots used in the surgery. There are described but do not fall within the scope of the invention a method to program a computer and connect it to a vision system to identify skeletal parts and have the computer identify their positional relationship to at least one of the body structure parts, and optionally control movement of at least one of the parts by a surgical robot to position the part for reassembly.

Other objectives and advantages of this invention will become apparent from the following description taken in conjunction with any accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. Any drawings contained herein constitute a part of this specification, include exemplary embodiments of the present invention, and illustrate various objects and features thereof.

While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred, albeit not limiting, embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated.

Referring to <FIG>, a schematic, block diagram illustration of a system, referred to generally as a surgical sensor anchor system <NUM> is illustrated. The surgical sensor anchor system <NUM> may comprise of any one element alone, or any two or more components in combination. The surgical sensor anchor system <NUM> is comprised of a surgical anchor <NUM>, a sensor <NUM>, an anchor delivery tool <NUM>, surgical equipment, such as a surgical robot <NUM> with software <NUM> to drive robotic functionality, and visualizing equipment <NUM>, such as a CT scan, ultrasound or fluoroscopy, and a sensor power source <NUM> and sensor control system <NUM>.

In use, the system and methods provide a mechanism for a safer and controlled robotically-assisted surgical procedure, as the robot will be able to respond to changes in the surgical environment and modify its programmed actions. This will be beneficial in the situation where a patient's body, and therefore the surgical site, is moved during a surgical procedure. When undertaken by a human, such action is not problematic, as humans have the capability to problem solve in real time. That is, the surgeon understands and processes that the body is moved and either moves it back or continues on the path knowing that the body is positioned differently. For a robot that is programmed to do an action, it does not understand such action and will continue to do what it is programmed to do, regardless of where the surgical site has been placed. This continued path can result in incomplete actions, or more importantly, performing an action on the wrong surgical site or body part/portion. Accordingly, if the body shifts, it would be necessary to stop the procedure and reprogram the robot pathway, resulting in increased surgical times and possible mistakes. As an illustrative example, the sensor <NUM> may be an electromagnetic sensor which can be temporarily attached to at least one portion of a body structure undergoing a surgical procedure or tracking movement of a body structure near a surgical site. For example, the surgical anchor <NUM> having a sensor <NUM> (or surgical sensor anchor <NUM>/<NUM> to be described later) may be temporarily fixed to each vertebra level during a spinal surgery. In a three-level fusion procedure, the surgeon temporarily anchors in three (<NUM>) separate surgical anchors <NUM> having a sensor <NUM> (or surgical sensor anchor <NUM> or <NUM>) at each level. The sensor may be used with an electromagnetic tracking system (see NDI Medical (Ontario, Canada) electromagnetic tracking system). In the utilization of the temporary sensors, i.e. sensor anchor <NUM>/<NUM>/<NUM> with sensor <NUM> on each vertebra level, the surgeon would provide an initial registration to plot the robot pathway using ultrasound or other known methods. Once the robot path system is determined and programmed, each sensor <NUM> would be turned on during cutting, drilling, and screwing into that particular level. The sensor would preferably track six degrees of freedom, i.e. in spinal procedure, flexion, extension, axial rotation, latero-lateral shear, anteroposterior shear, axial compression/decompression, and track any movement of the vertebra, providing feedback to the robot. The feedback information would then be used by the robot to adjust direction in real-time, or act accordingly, such as stopping the surgical procedure until human input is performed.

The sensor <NUM> can be an electromagnetic sensor which can be temporarily attached to at least one portion of a skeletal structure undergoing a surgical procedure or tracking movement of a skeletal part near a surgical site. For example, the surgical anchor <NUM> having a sensor <NUM> (or surgical sensor anchor <NUM>/<NUM> to be described later) may be temporarily fixed to a skeletal part during surgery as with a screw threaded portion. In a pelvis reconstruction procedure, the surgeon temporarily anchors in the appropriate number of surgical anchors <NUM>, optionally having a sensor <NUM> (or surgical sensor anchor <NUM> or <NUM>) at each level, into the skeletal parts to be repositioned for reconstruction, i.e., to assemble the broken parts back into as near a whole pelvis <NUM> as practicable. While the term pelvis is used herein, it is to be understood that other skeletal components can be treated with the herein described system and method, and in particular, plate like components including the pelvis and skull. The sensor <NUM> may be used with an electromagnetic tracking system (see NDI Medical (Ontario, Canada) electromagnetic tracking system). In the utilization of the sensors <NUM>, i.e. sensor anchor <NUM>, <NUM>, <NUM> with sensor <NUM> on each skeletal part, the surgeon would provide an initial registration to plot the robot pathway using ultrasound or other known methods.

Once the robot path system is determined and programmed, each sensor <NUM> would be turned on during the surgical procedure. The sensor (s) <NUM> would preferably track six degrees of freedom, i.e. in the reconstruction procedure, providing feedback to the robot to either move a particular skeletal part or to hold it in position for securement in proper place. The feedback information could also be used by the robot to adjust position or movement in real-time, or act accordingly, such as stopping the surgical procedure until human input is performed. The visualization system <NUM>, described in more detail below, can also be used to track movement of the various skeletal portions 1201A-1201D of a broken pelvis <NUM>.

Referring to <FIG>, an illustrative embodiment of a surgical anchor <NUM> for use in a surgical procedure and configured to house a sensor therein, referred to generally as a surgical anchor <NUM>, is illustrated. The surgical anchor <NUM> comprises a main body <NUM> having a first end <NUM> configured to engage with a body part or organ, such as a vertebra, and an opposing second end <NUM> positioned away from the body part when inserted therein. While the main body <NUM> is shown having a generally tubular shape, such shape is illustrative only and not limiting. The second end <NUM> contains an opening <NUM>. The opening <NUM> preferably has a diameter sufficient to allow the sensor <NUM> (shown with an electrical wire <NUM>) to be inserted into and stored within a lumen <NUM> in the interior region <NUM> of the surgical anchor <NUM>.

The first end <NUM> of the surgical anchor <NUM> may contain an initial insertion portion <NUM> constructed to aid in insertion into, for example, a vertebra. The partially threaded portion <NUM> allows the surgical anchor <NUM> to be screwed into and thereby secured to the vertebra. Positioned at or near the second end <NUM> is an insertion tool engaging member <NUM>. The insertion tool engaging member <NUM> is illustrated herein as an elongated flange <NUM> arranged in a generally parallel orientation relative to the anchor longitudinal axis <NUM> and extending inwardly towards a center of the surgical anchor <NUM>. The elongated flange <NUM> may comprise an angled or ramped surface <NUM> for guiding an insertion tool at one end, and end in a circumferential flange <NUM>. The circumferential flange <NUM> is illustrated having a generally circular shape or profile and extending around a perimeter of the anchor <NUM> main body <NUM>.

<FIG> illustrates an embodiment of the anchor, in accordance with the invention, for use in a surgical procedure and configured to house a sensor therein, referred to generally as a surgical sensor anchor <NUM>. The surgical sensor anchor <NUM> comprises a main body <NUM> having a first end <NUM> configured to engage with a body part or organ, such as a vertebra, and an opposing second end <NUM> positioned away from the body part when inserted therein. While the main body <NUM> is shown having a generally tubular shape, such shape is illustrative only and not limiting. The second end <NUM> contains an opening <NUM>. The opening <NUM> preferably has a diameter sufficient to allow the sensor <NUM> to be inserted into and stored within an interior region <NUM> of the surgical sensor anchor <NUM>. The first end <NUM> of the surgical sensor anchor <NUM> may contain an initial insertion portion <NUM> constructed to aid in insertion into, for example, a vertebra. A threaded portion <NUM> allows the surgical sensor anchor <NUM> to be screwed into and secured to the vertebra. The insertion portion <NUM> terminates in an initial body part engaging portion, illustrated herein as a sharp or pointed tip <NUM>. At, near, or extending from the first end <NUM>, preferably prior to the threaded portion <NUM>, is a circumferential flange <NUM>. The circumferential flange <NUM> is illustrated having a generally circular shape or profile and extending around a perimeter of the surgical sensor anchor <NUM> main body <NUM>.

Positioned along the outer surface <NUM> of the main body <NUM> is an insertion tool engaging member <NUM>. The insertion tool engaging member <NUM> is illustrated herein as an elongated body or flange <NUM> extending out from the outer surface <NUM> and arranged in a generally parallel orientation relative to the surgical anchor longitudinal axis <NUM>. The elongated body or flange <NUM> may comprise a first end <NUM>, shown having a generally rounded <NUM> profile, and a second, opposing end <NUM>, having a partial triangular profile with two surfaces <NUM> and <NUM> diverging from an edge or edge surface <NUM>. While the anchors <NUM>, <NUM> (and <NUM>) are shown as using a threaded shank to effect attachment to a skeletal component, it is to be understood that other forms of attachment can be used, such as adhesive attachment.

<FIG> illustrates an embodiment of an anchor delivery tool, referred to generally as a surgical anchor insertion tool <NUM> configured to engage with the surgical sensor anchor <NUM> or <NUM> (or <NUM>), delivering the surgical sensor anchor <NUM> or <NUM> (or <NUM>) to the required portion of the body in need of a surgical procedure. The surgical anchor insertion tool <NUM> comprises a first end <NUM>, configured to engage with the surgical sensor anchor <NUM> or <NUM> (or <NUM>), a second end <NUM>, and a main body shaft <NUM>. A handle <NUM>, shown as a T-shaped handle, is attached to or integrally formed to the second end <NUM>. As illustrated in <FIG>, the first end <NUM> has an opening <NUM> sized and shaped to receive and secure at least a portion of the surgical anchor <NUM> (<NUM>, <NUM>). The first end <NUM> comprises a slotted opening <NUM> running along the length of the shaft. The length of the slotted opening <NUM> is larger than the insertion tool engaging member <NUM>/<NUM> so the insertion tool engaging member <NUM>/<NUM> fits therein. The slotted opening <NUM> also allows the electrical wire <NUM> of the sensor <NUM> to be inserted into and rest therein.

<FIG> and <FIG> illustrate an alternative embodiment of the anchor delivery tool, referred to generally as a surgical anchor insertion tool with vertical spool <NUM>. The surgical anchor insertion tool with vertical spool <NUM> has a similar construction as described above for the surgical anchor insertion tool <NUM>. The surgical anchor insertion tool with vertical spool <NUM> comprises a first end <NUM> configured to engage with a secondary shaft <NUM>, a second end <NUM>, and a main body shaft <NUM>. A handle <NUM>, shown as a T-shaped handle, is attached to or integrally formed to the second end <NUM>. The secondary shaft <NUM> is configured to include, as a free standing, connectable component, or integrally formed thereto, a surgical anchor engaging member <NUM>. The surgical anchor engaging member <NUM> is configured to receive and secure the surgical sensor anchor <NUM>/<NUM>/<NUM> thereto. Attached to at least a portion of the main body shaft <NUM> is a vertical spool <NUM>.

Referring to <FIG> and <FIG>, an illustrative example of the vertical spool <NUM> is shown. The vertical spool <NUM> comprises two flanged members <NUM> and <NUM> separated by a hub (not shown) ; the hub being a sufficient size to allow the electrical wires of the sensor to be wrapped or unwrapped. The spool flanged member <NUM> comprises a first indented or recessed portion <NUM> sized and shaped to store a sensor connector <NUM> (<FIG>) therein. Sensor connector clasp prongs <NUM> maintain the connector in place when secured thereto. The spool flanged member <NUM> may also include side recessed portions, <NUM> and <NUM>. The side recessed portions <NUM> and <NUM> allow a user's finger (s) to easily grasp the sensor connector <NUM>, thereby providing a mechanism for easy removal.

The surgical sensor anchor <NUM> can be secured to the flanged member <NUM> through sensor clasp cradle prongs <NUM>. A hood cover <NUM> covers the sharp end of the surgical sensor anchor <NUM>. The spool flanged member <NUM> may contain a plurality of main body cradle prongs <NUM>, see <FIG>, each sized and shaped to allow portions of the main body shaft <NUM> to secure thereto. A vertical rib <NUM> may be used, and placed within the sensor clasp cradle prongs <NUM>, to prevent the vertical spool <NUM> from spinning.

Referring to <FIG>, the vertical spool <NUM> is shown with the surgical sensor anchor <NUM> slid out of the hood cover <NUM>. The user can remove the surgical sensor anchor <NUM> by snapping it out of sensor clasp cradle prongs <NUM>. The user can then uncoil enough of the wire <NUM> to insert the surgical sensor anchor <NUM> into the distal end of the surgical anchor insertion tool with vertical spool <NUM>, i.e. the surgical anchor engaging member <NUM>. As illustrated in <FIG>, the main body shaft <NUM> and the secondary shaft <NUM> comprise a body having a slotted opening <NUM> for main body shaft <NUM>, and a slotted opening <NUM> for the secondary shaft <NUM>. The slotted openings <NUM> and <NUM> are sized and shaped to receive and store therein the sensor electrical wire <NUM>. A wire retainer, illustrated herein as a rotatable sheath <NUM>, can be rotated to secure the wire therein, see <FIG>.

Once the surgical sensor anchor <NUM> is secured to the target site, i.e. a desired body portion that requires a surgical procedure, the user can snap the sensor connector <NUM> out of the spool <NUM>, see <FIG>, and uncoil the remainder of the sensor electrical wire <NUM>. The wire retainer rotatable sheath <NUM> is released, see <FIG>, and with a slight counterclockwise motion, the surgical anchor insertion tool with vertical spool <NUM> is released from the surgical sensor anchor <NUM>. The surgical anchor insertion tool with vertical spool <NUM> may then be removed from the surgical site. If needed, the sensor electrical wire <NUM> and the sensor connector <NUM> can be left on the vertical spool <NUM> and detached from the surgical anchor insertion tool with vertical spool <NUM> if the surgical sensor anchor <NUM> is not connected to sensor equipment, see <FIG>.

Referring back to <FIG>, the surgical sensor anchor <NUM> is removed from the surgical anchor insertion tool with vertical spool <NUM>, thereby exposing the surgical anchor engaging member <NUM>. The surgical anchor engaging member <NUM> includes a generally cylindrical body <NUM> having a longitudinal slot <NUM> running the length of the cylindrical body <NUM> and terminating in an opening <NUM>. A portion of the longitudinal slot <NUM> contains cut-outs <NUM> which are sized and shaped to receive the insertion tool engaging member <NUM> of the surgical sensor anchor <NUM>. The opening <NUM> is sized and shaped to be larger than the diameter of the surgical sensor anchor <NUM>. To rest securely in the surgical anchor engaging member <NUM>, the surgical sensor circumferential flange <NUM> is sized to have a larger diameter than the diameter of the opening <NUM> so as not to be fully inserted therein.

Referring to <FIG>, an alternative embodiment of the anchor delivery tool, referred to generally as a surgical anchor insertion tool with horizontal spool <NUM> is illustrated. The surgical anchor insertion tool with horizontal spool <NUM> has a similar construction as described above for the surgical anchor insertion tool <NUM> or <NUM>. The surgical anchor insertion tool with horizontal spool <NUM> comprises a first end <NUM> configured to engage with a secondary shaft <NUM>, a second end <NUM>, and a main body shaft <NUM>. A handle <NUM>, shown as a T-shaped handle, is attached to or integrally formed to the second end <NUM>. The secondary shaft <NUM> is configured to include, as a free standing, connectable component, or integrally formed thereto, a surgical anchor engaging member <NUM>. The surgical anchor engaging member <NUM> is configured to receive and secure the surgical sensor anchor <NUM>/<NUM>/<NUM> thereto. Each of the components described above comprise the same features and construction as that describe for the surgical anchor insertion tool with vertical spool <NUM>.

Attached to at least a portion of the main body shaft <NUM> is a horizontal spool <NUM>. The horizontal spool <NUM> comprises a first flanged member <NUM>, a second flanged member <NUM>, and a hub (not shown, but preferably in the shape of a spool drum) separating the two flanged members. The hub is of a sufficient size to allow the electrical wires of the sensor to be wrapped or unwrapped. The horizontal spool first flanged member <NUM> may be configured to store one or more components, such as the surgical sensor anchor <NUM> or the surgical sensor connector <NUM>. Accordingly, the horizontal spool first flanged member <NUM> may comprise a sensor anchor cradle with prongs <NUM> configured to maintain the surgical sensor anchor <NUM> in place, when secured thereto, and a hood <NUM>. The horizontal spool first flanged member <NUM> may further comprise a sensor connector cradle with prongs <NUM> configured to maintain the sensor connector <NUM> in place when secured thereto.

<FIG> illustrates the horizontal spool <NUM> configured for transporting of one or more components. In this configuration, the surgical sensor <NUM> is mounted into the surgical sensor anchor <NUM>. The surgical sensor anchor <NUM> is snapped into the sensor cradle with prongs <NUM> on the spool for transport. The hood <NUM> covers the sharp tip of the surgical sensor anchor <NUM>. The sensor wire <NUM> is coiled onto the spool <NUM>, and then the connector <NUM> is snapped into its cradle <NUM>. The anchor delivery tool and T-shaped handle may or may not be included with the kit. As illustrated, the secondary shaft <NUM>, main body shaft <NUM>, and the surgical anchor engaging member <NUM> are shown secured to the horizontal spool <NUM>. The T-shaped handle <NUM> is shown secured to the second flanged <NUM> member, see <FIG>. As illustrated, the main body <NUM> has a hex shaped end <NUM> sized and shaped to secure to the corresponding T-shaped handle hex-shaped coupler <NUM>.

The horizontal spool <NUM> comprises a central opening <NUM>, see for example <FIG>. The central opening <NUM> has a sufficient diameter to allow portions of the surgical anchor insertion tool <NUM> to pass therethrough. Accordingly, a user can separate the main body <NUM> and T-shaped handle <NUM>, see <FIG>, from the horizontal spool <NUM>, if necessary, and insert the main body <NUM> into the central opening <NUM> with the tool delivery components attached thereto, facing away from the distal end (the end furthest away from a user when the user is engaging the T-shaped handle). A central support member <NUM>, having a generally cylindrical shape with a slotted cut out <NUM>, supports portions of the main body <NUM> when inserted therein, see <FIG> and <FIG>. The slotted cut out <NUM> is sized and shaped so as to align with the slotted opening <NUM> of secondary shaft <NUM> of the main body <NUM>. To aid in dispensing or storing of the sensor electrical wire <NUM>, the horizontal spool first flanged member <NUM> also contains a cut out channel <NUM>.

Referring to <FIG>, an alternative embodiment of the anchor delivery tool, referred to generally as a pass through surgical anchor insertion tool <NUM> is illustrated. The pass through surgical anchor insertion tool <NUM> has the same construction as described above for the surgical anchor insertion tool <NUM> or <NUM>, differing in the handle portion. The pass through surgical anchor insertion tool <NUM> comprises a first end <NUM> configured to engage with a secondary shaft <NUM>, a second end <NUM>, a main body shaft <NUM>, and a surgical anchor engaging member <NUM>. A handle <NUM> is attached to or integrally formed to the second end <NUM>. Except for the handle <NUM>, each of the components described above comprise the same features and construction as that described for the surgical anchor insertion tools, <NUM> or <NUM>. The handle <NUM> comprises a handle body <NUM> having an open slot <NUM> running the entire length. The open slot <NUM> is sized and shaped to receive and hold a portion of the sensor electrical wire <NUM>. At the top surface <NUM> is a handle wire retaining member <NUM>. Rotating the wire retaining member <NUM> by gripping the tabs <NUM> and <NUM> locks the sensor surgical wire <NUM> in place, see <FIG>. <FIG> illustrates a cross sectional view of the handle wire retaining member <NUM>. The handle wire retaining member <NUM> contains an inwardly sloping funnel surface <NUM>, ending in an offset <NUM>. The offset <NUM> cams into place to trap the sensor electrical wire <NUM>, see <FIG>.

Referring to <FIG>, an alternative embodiment of the anchor delivery tool, referred to generally as a surgical anchor insertion tool with spool <NUM> is illustrated. The surgical anchor insertion tool with spool <NUM> comprises the same features as any of the other delivery tools described herein, differing in the spool connection, and having a first end <NUM> configured to engage with a secondary shaft <NUM>, a main body shaft <NUM>, a surgical anchor engaging member <NUM>, and a handle <NUM>. The spool <NUM> comprises a first flanged member <NUM>, a second flanged member <NUM>, and a drum <NUM> (shown with electrical wire <NUM> wrapped around). The spool <NUM> preferably secures to portions of the main body shaft <NUM>.

Each of the sensor anchor delivery tools described herein are configured to allow a user to deliver the surgical sensor anchor <NUM> or <NUM> to the required portion of the body in need of a surgical procedure. <FIG> illustrates the use of the surgical anchor insertion tool <NUM> to deliver the surgical anchor <NUM> to one or more vertebral bodies <NUM> of the spinal cord <NUM>. <FIG> illustrates the insertion of multiple surgical sensor anchors <NUM>, each with an electrical wire <NUM> attached thereto, to independent vertebral bodies, <NUM>. In addition to being utilized by a human user, i.e. a surgeon, the surgical sensor anchor delivery tools can be adapted to be used by a surgical robot. <FIG> illustrates the surgical anchor insertion tool with horizontal spool <NUM> with the handle removed, attached to a surgical robot <NUM>. Preferably, the robot (s) <NUM> is a mini robot so multiple robots <NUM> can be used simultaneously. While only one robot <NUM> is shown, it is to be understood that a plurality of robots can be used. Such surgical robots are well known in the art and have multiple axes of freedom, for example, six or seven axes of freedom. The robot <NUM> includes a base <NUM> and an arm, designated generally <NUM>, which is comprised of a plurality of relatively movable sections 1156A-1156C and a head <NUM>. The head <NUM> has a free end portion <NUM> that is configured to hold various end effectors and/or manipulators, such as tools and grippers, or as shown, an anchor <NUM>. The base <NUM> is provided to support the arm portions 1156A-1156C and the head <NUM>. While an anchor <NUM> is shown as being manipulated by the robot <NUM>, it is to be understood that other tools, such as a gripper, can be mounted to the head <NUM> for gripping and/or manipulating an anchor <NUM>, <NUM>, or to grip a bone fragment directly for manipulation by the robot <NUM>.

The surgical system, designated generally <NUM> and illustrated in <FIG>, includes at least one robot <NUM>, a computer <NUM> having a memory <NUM>, and a processor <NUM>, and is preferably a digital computer. The surgical system <NUM> also includes a manually operated controller, such as a telemanipulator <NUM>, for use by a surgeon or other medical personnel. The surgical system <NUM> also includes a display device <NUM>, such as a touch screen monitor. The surgical system <NUM> also includes the visualization system <NUM>. The visualization system <NUM>, controller <NUM>, display <NUM> and robot <NUM> are operably connected together via the computer <NUM>. The computer <NUM> is programmed to effect the following described functions.

When performing surgery on a skeletal component, such as a pelvis <NUM>, the surgical site is exposed as is known in the art. The visualization system <NUM> can be used to create an image of the surgical site to provide an image thereof on the display <NUM> to determine the degree of damage and the location of the various fragments, such as the fragments 1201A-1201D. If needed, one or more of the robots <NUM> can be used to install anchors <NUM>, <NUM>, or to grip a fragment with a suitable gripping device, such as a pair of jaws mounted to one or more of the robots <NUM>. The selection of the use of an anchor or a gripping device can be determined by the surgeon and/or the computer <NUM> in accordance with the computer programming. Depending on the type of scan of the surgical area to be made, the scan can be accomplished prior to opening the surgical site and/or after opening the surgical site as instructed by the surgeon. The computer <NUM> can be programmed to process the information from the scan to determine how the various skeletal fragments are to be repositioned for reconstruction of the broken skeletal component, such as a pelvis. The computer <NUM> can be programmed to at least initially determine whether the skeletal component will be gripped with a gripping device or have an anchor installed therein. An image from the scan can be displayed on the display device <NUM> to provide information to the surgeon or other medical personnel. The computer <NUM> can also be programmed to determine which fragment <NUM> goes in which position relative to the other fragments. The moving of the fragments 1201A-1201D into their appropriate positions for reconstruction can be done robotically and/or by the surgeon or other medical personnel.

Additionally, the surgeon can manually control a robot <NUM> to move a tool into position to grip a fragment, either by gripping the fragment itself or an anchor <NUM> as described above. The surgeon can manually move a fragment <NUM> into its appropriate position through the controller <NUM>, through a touchscreen on the display <NUM>, or by manual manipulation of the robot <NUM>. The robot <NUM> can then be instructed by the surgeon or other medical personnel to maintain that position, i.e. the robot can learn from the instruction what its function should be; for example, hold the fragment in place or move the fragment to another position. This can be done via the controller <NUM> or a touchscreen <NUM>. Further, control elements such as an input switch can be provided on the robot <NUM> to assist in instructing the robot <NUM> what to do, which would then be controlled by the computer <NUM>. Fragment identification can be through the sensor <NUM> embedded in an anchor <NUM>, <NUM> as described above. It is to be noted that the reconstruction process can utilize more than one robot <NUM> simultaneously and independently at one time. It is also to be understood that more than one medical personnel can be utilized to effect operation of the surgical system <NUM>. For example, the surgeon could move a fragment into place and instruct other personnel to instruct the computer <NUM> to learn. Learning can utilize more than one instruction, for example, a first instruction would be to learn and a second instruction would be to hold in place. Visualization can be at the beginning of the surgical process, intermittently during the surgery, or continuously throughout the surgery.

Once the fragments are properly positioned, the robot or robots <NUM> can maintain the fragments in their appropriate position while the surgeon can secure the fragments in place with either screws, adhesive or other means, as is well known in the art. Alternatively, additional robots can connect the bone fragments utilizing bone plates, screws and the like. After the reconstruction, the surgical site can be closed. Also, the visualization can include a scan of the completed reconstruction.

<FIG> illustrates an alternative embodiment of the anchor for use in a surgical procedure, which may be configured to house a sensor therein, referred to generally as a surgical sensor anchor <NUM>. The surgical sensor anchor <NUM> comprises a main body <NUM> having a first end <NUM> configured to engage with a body part or organ, such as a vertebra, and an opposing second end <NUM> positioned away from the body part when inserted therein. While the main body <NUM> is shown having a generally tubular shape, such shape is illustrative only and not limiting. The second end <NUM> includes a geometric shape <NUM>. The geometric shape <NUM> is sized and shaped to include a surface finish configured to cooperate with an inspection camera <NUM> secured in close proximity to the anchor. The inspection camera is of the type typically utilized for inspecting production line parts in real time. Such inspection systems are currently utilized for determining part orientation, tolerance monitoring and part presence, and are manufactured by at least ATS Automation, <NUM> Fountain St. , Building #<NUM>, Cambridge ON. N3H 4R7 Canada. These cameras typically use pixel differentiation, contrast algorithms, or the like, to determine the size of a part as it/s viewed by the camera from a fixed distance. This type of inspection camera system is modified from its typical inspection use to track movement of the part in place of one of the typical functions, such as part tolerance monitoring. Movement, including orientation and yaw of the geometric shape, is monitored to determine how far the anchor <NUM>, and thus the body part, has moved or rotated. In at least one embodiment, the anchor <NUM> is provided with an opening <NUM> sized to allow the sensor <NUM> to be inserted into and stored within an interior region <NUM> of the surgical sensor anchor <NUM>. In addition to the electromagnetic sensors <NUM>, small gyroscopes or inertia sensors, such as those found in cell phones, may be inserted into the hollow shank of the anchor <NUM>. The first end <NUM> of the surgical sensor anchor <NUM> may contain an initial insertion portion <NUM> constructed to aid in insertion into, for example, a vertebra. A threaded portion <NUM> allows the surgical sensor anchor <NUM> to be screwed into and secured to the vertebra or other anatomical structure. The insertion portion <NUM> terminates in an initial body part engaging portion, illustrated herein as a sharp or pointed tip <NUM>. At, near, or extending from the first end <NUM>, preferably prior to the threaded portion <NUM>, is a circumferential flange <NUM>. The circumferential flange <NUM> is illustrated having a generally circular shape or profile and extending around a perimeter of the surgical sensor anchor <NUM> main body <NUM>.

Positioned along the outer surface <NUM> of the main body <NUM> is an insertion tool engaging aperture <NUM>. The insertion tool engaging aperture <NUM> is illustrated herein as a non-limiting TORX drive and arranged in a generally parallel orientation relative to the surgical anchor longitudinal axis <NUM>. It should be noted that the TORX driver is illustrated; however, any inwardly or outwardly extending shape suitable for inserting the anchor into the anatomy could be substituted without departing from the scope of the art.

Referring to <FIG>, an alternative embodiment of the surgical sensor anchor <NUM> is illustrated. This embodiment includes an outwardly extending secondary geometric shape <NUM> that may also be monitored by one or more cameras <NUM> to provide additional axes of monitoring. The secondary geometric shape <NUM> preferably includes a protuberance shape <NUM> that allows for the camera to monitor rotation and yaw angle of the anchor about the longitudinal axis <NUM> in addition to the X, Y and Z monitoring provided by geometric shape <NUM>, and thus the anatomy to which it is attached. The protuberance shape also allows for insertion of the anchor by providing a driving surface <NUM>. It should also be noted that a single shaped surface in combination with a single inspection camera <NUM> can be used to measure up to six (<NUM>) degrees of freedom of movement by modifying or combining geometric shapes. An example of such a shape is parallelepiped or cylindrical. <FIG> illustrates the surgical sensor anchor <NUM> in which the geometric shape <NUM> and the secondary geometric shape <NUM> are both cylindrical. Although not illustrated, an embodiment of the surgical sensor anchor <NUM> may include just the geometric shape <NUM> having a shape that is not round, such as cylindrical.

The sensor control system <NUM> preferably includes one or more sensor control modules. Each sensor control module is a software-based interactive processing program that interacts with surgical personnel through a graphical user interface presented on an output display device. The sensor control module allows a user to create and store positions, e.g. define, sensor anchors as fiducial markers with respect to known fiducial points of the patient' s anatomy, and particularly the skeletal structure. To monitor the stored positions, the sensor control module may include a boundary definition function that allows the user
marker an; sensor anchors,, and may additionally hide extraneous image data that is outside the bounded area. In this manner, the user can define a boundary for movement of the fiducial marker that may trigger alarms, stop the surgical procedure tor realignment or recalibration, or may adjust the positioning and movements of the robot (s) to compensate for the monitored movement of the anatomy.

<FIG> illustrate an embodiment of the surgical sensor anchor <NUM> which comprises an antenna fiducial <NUM>. The antenna fiducial <NUM> may contain a support structure <NUM> and two or more geometrical shapes, <NUM> and <NUM>. Geometric shape <NUM> and geometric shape <NUM> are sized and shaped to include a surface finish configured to cooperate with an inspection camera <NUM> secured in close proximity to the anchor and can be used to measure up to six (<NUM>) degrees of freedom of movement. As shown, geometric shape <NUM> and geometric shape <NUM> are orientated in a generally linear manner, or at least in the same plane. Geometric shape <NUM> and geometric shape <NUM> are also orientated in a generally linear manner, or at least in the same plane. Relative to geometric shape <NUM>, geometric shape <NUM> is oriented in a different plane and is off center from surgical anchor longitudinal axis <NUM>. The antenna fiducial <NUM> may be permanently attached.

Alternatively, the antenna fiducial <NUM> may be configured to be removably attached. In this manner, the antenna fiducial <NUM> can be left in for use in measuring various degrees of freedom of movement or removed for single geometric shape sensing.

<FIG> is a cross sectional view of the embodiment of the surgical sensor anchor <NUM> illustrated in <FIG>, taken along the surgical anchor longitudinal axis <NUM>, with geometric shape <NUM> and second geometric shape <NUM>. The internal lumen or area <NUM> is shown housing sensor <NUM> and primary sensor wire <NUM> (out through port <NUM>) and optionally a secondary electrical wire <NUM>, (out through optional secondary wire port <NUM>. The surgical sensor anchor <NUM> may include an optional secondary sensor (s) <NUM>, to provide for both electromagnetic (<NUM>) and optical (<NUM>) sensing, such as an accelerometer sensor, an ultrasound sensor, or multiple sensors, such as a combination of accelerometer and ultrasound sensors.

<FIG> illustrate an alternative embodiment of the anchor delivery tool, referred to generally as surgical anchor insertion tool with ball shaped spool <NUM>, shown adapted to interact with the surgical sensor anchor <NUM>. The surgical anchor insertion tool with ball shaped spool <NUM> comprises a first end <NUM>, a second end <NUM>, and a main body shaft <NUM>. A handle <NUM>, shown as a T-shaped handle, is attached to or integrally formed to the first end <NUM>. The second end <NUM> includes surgical anchor engaging member <NUM>. The surgical anchor engaging member <NUM> is configured to receive and secure the surgical sensor anchor <NUM> (or sensor anchor <NUM>/<NUM>) thereto. In this embodiment, the surgical anchor engaging member <NUM> is sized and shaped to fit within or engage with at least a portion of the surgical sensor anchor <NUM>, preferably the insertion tool engaging aperture <NUM>, see <FIG> and <FIG>. Attached to at least a portion of the main body shaft <NUM> is a ball shaped spool <NUM>. The ball shaped spool <NUM> comprises a support frame <NUM> which is sized and shaped to engage with and secure to at least a portion of the main body shaft <NUM>.

The ball shaped spool <NUM> contains a main compartment <NUM> having various securing members, illustrated herein as clasp cradle prongs <NUM> for securing the surgical sensor anchor <NUM> or the sensor connector <NUM> in place. Secondary compartments 528A and 528B can be used to store or secure the sensor electrical wire <NUM>. The main body shaft <NUM> contains a slot <NUM> which allows the sensor electrical wire <NUM> to remain in place. Sleeve <NUM>, surrounding a portion of the main body shaft <NUM> contains a slotted opening <NUM>. The sleeve <NUM> maintains the sensor electrical wire <NUM> in place during attachment of the surgical sensor anchor <NUM>. Rotation of the sleeve <NUM> allows the sensor electrical wire <NUM> freedom to be moved away from the main body shaft <NUM>. Sleeve <NUM> may be locked in place via a sleeve locking member, illustrated herein as sleeve slot <NUM> and pin <NUM>.

All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains.

It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention, and the invention is not to be considered limited to what is shown and described in the specification and any drawings/ figures included herein.

Claim 1:
A surgical sensor anchor system (<NUM>) for use in surgical procedures utilizing robotic devices comprising:
- a surgical sensor anchor (<NUM>, <NUM>, <NUM>), said surgical sensor anchor (<NUM>,<NUM>,<NUM>) comprising:
- a main body (<NUM>,<NUM>) having a first end (<NUM>,<NUM>) configured to engage with a body part or organ, said first end comprising a threaded portion (<NUM>,<NUM>), and an opposing second end (<NUM>,<NUM>) positioned at a distance from said body part when the surgical sensor anchor (<NUM>,<NUM>,<NUM>) is inserted therein; and
- the main body (<NUM>,<NUM>) separating said first end (<NUM>,<NUM>) and said second end (<NUM>,<NUM>), and said main body (<NUM>, <NUM>) having a tubular shape, an interior region (<NUM>), an outer surface (<NUM>) and an insertion tool engaging member (<NUM>,<NUM>) configured for engaging with an insertion tool and positioned along the outer surface (<NUM>) of the main body (<NUM>, <NUM>),
- wherein the body part is a skeletal structure and the system comprises an electromagnetic sensor (<NUM>), said electromagnetic sensor being housed within said interior region (<NUM>) of said main body (<NUM>,<NUM>) so as to be temporarily attached to at least one portion of a skeletal structure undergoing a surgical procedure for use in tracking movement of at least one portion of a body structure undergoing a surgical procedure or tracking movement of a skeletal part near a surgical site, characterized in that
- the insertion tool engaging member (<NUM>) is an elongated flange (<NUM>) extending out from the outer surface (<NUM>) and arranged in a generally parallel orientation relative to a surgical anchor longitudinal axis (<NUM>) and
- the elongated flange (<NUM>) comprises a first end (<NUM>) having a generally rounded (<NUM>) profile, and a second opposing end (<NUM>) having a partial triangular profile with two surfaces (<NUM>, <NUM>) diverging from an edge or edge surface (<NUM>).