Patent Description:
A dilation introducer for orthopedic surgery is described in document <CIT> for minimally invasive access for insertion of an intervertebral implant. The dilation introducer may be used to provide an access position through Kambin's triangle form a posterolateral approach. A first dilator tube with a first longitudinal axis is provided. A second dilator tube may be introduced over the first, advanced along a second longitudinal axis parallel to but offset from the first. A third dilator tube may be introduced over the second, advanced along a third longitudinal axis parallel to but offset from both the first and the second. An access cannula may be introduced over the third dilator tube. With the first, second, and third dilator tubes removed, surgical instruments may pass through the access cannula to operate on an intervertebral disc and/or insert an intervertebral implant.

Document <CIT> discloses tissue dilation systems providing percutaneous access to one or more target structures located in a patient's body. The tissue dilation systems include two or more tissue dilation tubes telescopically arranged and movable relative to each other. The tissue dilation tubes can be reassembled prior to use by utilizing a dilation tube retention assembly which can maintain the dilation tubes in a substantially fixed position and release the tubes therefrom in order to dilate a patient's tissue.

Document <CIT> is directed to a sequential dilator for use in surgery and a method for using the sequential dilator. The sequential dilator may have a bullet-shaped dilator and a plurality of dilator tubes with a removable handle. The method may include inserting a guide wire through an incision into a patient's vertebra and subsequently inserting the bullet-shaped dilator and dilator tubes with tapered ends and of increasing size into the incision to increase the size of the incision.

A method and apparatus to perform a procedure that can include a processor assisted surgical procedure. During the procedure patient space and image space can be registered to allow for tracking of various tracking sensors. A dynamic reference frame can be used to maintain localization of the patient space with the image space. The dynamic reference frame can be fixedly interconnected with a bone portion of the anatomy.

The multi-stage dilator and cannula assembly of the invention, for use in surgical procedures, including minimally invasive surgical procedures, to provide tissue dilation and opening of a portal to enable the surgeon to access and provide treatment to anatomical feature of interest is defined in claim <NUM>.

The multi-stage dilator and cannula assembly of claim <NUM> includes a plurality of elongated members in a nested configuration that are slidable relative to one another along a central axis, each member having a length dimension between a head end and a tip end of the member, and each successive member of the plurality of members extending radially outward from a central member has a larger outer dimension and a shorter length dimension than the preceding member.

In various embodiments, the plurality of elongated members is configured such that an application of a force in a first direction on the head end of a first member causes the first member and any members of the assembly located radially outward of the first member to move in the first direction, such as into the body of a patient. The first member and any members located radially outward of the first member may be moved in the first direction relative to any members of the assembly located radially inward of the first member. In embodiments, the application of a force on the first member in a second direction opposite the first direction causes the first member to move in the second direction relative to any members of the assembly located radially outward of the first member.

Other features and advantages of the present invention will be apparent from the following detailed description, taken in conjunction with the accompanying drawings of which:.

References made to particular examples and implementations are for illustrative purposes, and are not intended to limit the scope of the invention as defined in the claims.

An embodiment of a multi-stage dilator and cannula assembly <NUM> is illustrated in <FIG> and <FIG>. The assembly <NUM> includes a plurality of elongated members <NUM>, <NUM>, <NUM> in a nested configuration such that the members <NUM>, <NUM> and <NUM> may slide relative to one another along a longitudinal axis, a. The first member <NUM> may have either a hollow or solid interior and may comprise a needle, a cannula or a similar elongated structure. The second member <NUM> may comprise a cannula having a central opening extending lengthwise through the second member <NUM> and sized and shaped to receive the first member <NUM> in sliding engagement. The third member <NUM> may also comprise a cannula having a central opening extending lengthwise through the third member <NUM> and sized and shaped to receive the second member <NUM> in sliding engagement.

Each of the members <NUM>, <NUM> and <NUM> has a length extending between a first end (i.e., a head end <NUM>) and a second end (i.e., a tip end <NUM>) of the member. Proximate to the head end <NUM> of each of the members may be one or more features, such as a handle, knob, flange, etc., that may enable a user to easily grip and manipulate the members. The lengths of the members <NUM>, <NUM> and <NUM> may vary, such that the length of the first member <NUM> may be greater than the length of the second member <NUM>, and the length of the second member <NUM> may be greater than the length of the third member <NUM>. <FIG> illustrates the assembly <NUM> with the head ends <NUM> of the members <NUM>, <NUM> and <NUM> positioned adjacent to one another. In this configuration, the tip end <NUM> of the first member <NUM> extends beyond the tip end <NUM> of the second member <NUM> by a distance, d<NUM>, and the tip end <NUM> of the second member <NUM> extends beyond the tip end <NUM> of the third member <NUM> by a distance, d<NUM>. <FIG> illustrates the assembly <NUM> in a different configuration where the tip ends <NUM> of the members <NUM>, <NUM> and <NUM> are substantially coincident with one another and the head ends <NUM> of the members <NUM>, <NUM> and <NUM> are spaced apart.

A multi-stage dilator and cannula assembly <NUM> according to various embodiments may include a plurality of nested tubular or hollow members (e.g., cannulas) around a central (e.g., pilot) member, where extending radially outward from the central member, each successive member may have a relatively larger outer dimension (i.e., diameter) and a relatively shorter length dimension. In one non-limiting example, the first or central member <NUM> may have an outer diameter of approximately <NUM> (e.g., <NUM>-<NUM>), the second member <NUM> which surrounds the first member <NUM> may have an inner diameter of approximately <NUM> (e.g., <NUM>-<NUM>) and an outer diameter of approximately <NUM> (e.g., <NUM>-<NUM>), and the third member <NUM> which surrounds the second member <NUM> may have an inner diameter of approximately <NUM> (e.g., <NUM>-<NUM>) and an outer diameter of approximately <NUM> (e.g., <NUM>-<NUM>). When the assembly <NUM> is configured as shown in <FIG>, the tip end <NUM> of the first or central member <NUM> may extend beyond the tip end <NUM> of the second member <NUM> by a distance of approximately <NUM> (e.g., <NUM>-<NUM>) and the tip end <NUM> of the second member <NUM> may extend beyond the tip end <NUM> of the third member <NUM> by a distance of approximately <NUM> (e.g., <NUM>-<NUM>). The assembly <NUM> as a whole may be relatively rigid, with the larger-diameter and relatively stiffer outer cannula members <NUM> and <NUM> surrounding and supporting the smaller-diameter central (e.g., pilot) member <NUM> over a large portion of its length (e.g., > <NUM>%, such as <NUM>-<NUM>%) when the assembly <NUM> is in the configuration shown in <FIG>.

As discussed above, each of the members <NUM>, <NUM> and <NUM> may include a feature such as a handle, knob, flange, etc., which may be located proximate the head end <NUM> of the member that may enable a user to easily grip and manipulate the members, such as by applying a downward force on a member in the direction of arrow A, or an upward force on a member in the direction of arrow B. In the exemplary embodiment of <FIG>, the first member <NUM> includes a handle <NUM> at the head end <NUM>, and the second member <NUM> includes a flange <NUM> at the head end <NUM> that extends transverse to the length dimension of the member <NUM>, and the third member <NUM> also includes a flange <NUM> at the head end <NUM> that extends transverse to the length dimension of the member <NUM>. In this embodiment, the third member <NUM> also includes a c-shaped protrusion <NUM> that extends from flange <NUM> in the direction of the handle <NUM> of the first member <NUM> and which may facilitate grasping and holding of the entire assembly <NUM> by a user.

At least some of the members in the assembly <NUM> may include one or more features that are configured to "capture" one or more members located radially outward from that member in the nested assembly <NUM>, such that when a particular member having such a feature is pushed in a first direction (e.g., a force is applied to the member in the direction of arrow A in <FIG>), the member being pushed also pushes on the one or more members of the nested assembly <NUM> located radially-outward from the member being pushed, causing the member being pushed and the member(s) located radially-outward from that member to move together in the direction of the applied force. Any member(s) located radially inward from the member being pushed may not be similarly "captured," and thus may not move together with the member being pushed in the direction of the applied force.

In the embodiment shown in <FIG>, for example, the handle <NUM> of the first member <NUM> is larger than the opening in the second member <NUM> in a direction transverse to the length dimension of the second member <NUM>, so that when first member <NUM> is pushed in the direction of arrow A, the handle <NUM> of the first member <NUM> pushes down on and captures the second member <NUM>, thereby causing the second member <NUM> to advance in the direction of arrow A in conjunction with the first member <NUM>. Similarly, the flange <NUM> of the second member <NUM> is dimensioned larger than the opening in the third member <NUM> so that when the second member <NUM> is pushed in the direction of arrow A (i.e., either by the second member <NUM> being directly pushed or by it being "captured" by the advancement of the first member <NUM>), the flange <NUM> of the second member <NUM> pushes down on an captures the third member <NUM>, thereby causing the third member to advance in the direction of arrow A in conjunction with the second member <NUM>.

It is noted that in this embodiment, advancing a member in the direction of arrow A does not result in the member pushing down on and "capturing" any member that is located radially-inward from the member being pushed in the nested assembly <NUM>. For example, when the third member <NUM> is advanced in the direction of arrow A, such as by a user directly applying a force to the flange <NUM> of the third member <NUM>, the third member <NUM> may freely slide in the direction of arrow A relative to the first and second members <NUM>, <NUM>, which are located radially-inward from the third member <NUM>. Similarly, applying a direct force in the direction of arrow A to the flange <NUM> of the second member <NUM> will "capture" the third member <NUM> (which is located radially-outward from the second member <NUM>) but does not capture the first member <NUM> (which is located radially-inward from the second member <NUM>). Thus, the second and third members <NUM> and <NUM> may be advanced together in the direction of arrow A relative to the first member <NUM>, which is not similarly advanced.

It is further noted that in the nested assembly <NUM> of <FIG>, the members to not "capture" any of the members that are located radially-outward when the member is moved in the direction of arrow B. For example, the first or central member <NUM> may move freely with respect to the second and third members <NUM> and <NUM> in the direction of arrow B and may be removed from the assembly <NUM>. Similarly, the second member <NUM> may move freely with respect to the third member <NUM> in the direction of arrow B and may also be removed from the outermost member <NUM> assembly <NUM>.

Although the multi-stage dilator and cannula assembly <NUM> of <FIG> illustrates three members <NUM>, <NUM> and <NUM> in a nested configuration, it will be understood that an assembly <NUM> in various embodiments may include only two nested members (e.g., members <NUM> and <NUM>) or may include more than three nested members (e.g., one or more additional members may be located radially outwards from third member <NUM>).

The embodiment of <FIG> also includes a marker device <NUM> which may be used for a motion tracking/surgical navigation system, as described in further detail below. Various systems and technologies exist for tracking the position (including location and/or orientation) of objects as they move within a three-dimensional space. Such systems may include a plurality of active or passive markers fixed to the object(s) to be tracked and a sensing device that detects radiation emitted by or reflected from the markers. A 3D model of the space may be constructed in software based on the signals detected by the sensing device.

The marker device <NUM> of <FIG> includes a set of markers <NUM> secured to a rigid support structure <NUM>. The markers <NUM> may comprise passive markers that are configured to reflect light at particular wavelengths (e.g., IR light) or may be active markers having a light source (e.g., LED source) for generating light in a particular wavelength or wavelength range that may be sensed by a sensing device (e.g., one or more cameras) as described above. The markers <NUM> may be secured to the support structure <NUM> to provide a fixed, known geometric relationship of the markers <NUM> to each other and to the assembly <NUM>, which may enable both the position (x, y, z) and the orientation (yaw, pitch, roll) of the assembly <NUM> to be fully resolved. The particular geometric pattern of the markers <NUM> may be associated with the assembly <NUM> in the motion tracking software, and may enable the motion tracking system to identify and track the assembly <NUM> in three-dimensional space. In this embodiment, the marker device <NUM> is secured to the c-shaped protrusion <NUM> of the third member <NUM> of the assembly <NUM>, although it would be understood that the marker device may be secured at another position on the assembly <NUM>. In embodiments, the support structure <NUM> of the marker device <NUM> may be integrally formed with a component of the assembly <NUM>.

A multi-stage dilator and cannula assembly <NUM> such as shown in <FIG> may be used in surgical procedures, including minimally invasive surgical procedures, to provide tissue dilation and opening of a portal to enable the surgeon to access and provide treatment to anatomical feature of interest. <FIG> schematically illustrate an assembly <NUM> such as described above used to perform a surgical procedure. In the non-limiting embodiment of <FIG>, the assembly <NUM> is used to perform a minimally-invasive spinal surgical procedure, although it will be understood that an assembly <NUM> of the present disclosure is not limited to use in such procedures, and may be used in a wide variety of surgical procedures, including, without limitation, various types of orthopedic, neurological, cardiothoracic and general surgical procedures.

<FIG> illustrates a patient <NUM> supported in a prone position, such as on a surgical table (not shown for clarity). A holding mechanism <NUM> configured to receive a multi-stage dilator and cannula assembly <NUM> as described above is located above the patient <NUM>. The holding mechanism <NUM> is preferably attached to a suitable support structure (not shown in <FIG> for clarity) that may maintain the position and orientation of the holding mechanism <NUM> with respect to the patient <NUM>. In some embodiments, the support structure may be a moveable arm or boom to which the holding mechanism <NUM> is attached, and which may be locked in place when the holding mechanism <NUM> is moved to a desired position and orientation with respect to the patient <NUM>. In some embodiments, such as described with reference to <FIG> below, the support structure may be a robotic arm and the holding mechanism <NUM> may comprise an end effector <NUM> attached to the end of the robotic arm <NUM> (see <FIG>). The robotic arm may be controlled to move the end effector to a desired position and orientation with respect to the patient <NUM>. The end effector/holding mechanism <NUM> may include a marker device <NUM> similar to the marker device <NUM> described above with reference to <FIG> to enable the position and/or orientation of the end effector/holding mechanism <NUM> to be tracked using a motion tracking system.

The end effector/holding mechanism <NUM> may include a hollow tube or cannula <NUM> that may be sized and shaped to receive a multi-stage dilator and cannula assembly <NUM> as described above. <FIG> illustrates the multi-stage dilator and cannula assembly <NUM> inserted into the hollow tube or cannula <NUM>. The assembly <NUM> is configured as shown in <FIG>, with the head ends <NUM> of the nested members <NUM>, <NUM>, <NUM> positioned adjacent to one another, the tip end <NUM> of the first (i.e., pilot) member <NUM> projecting a short distance (e.g., approximately <NUM>) below the tip end <NUM> of the second member <NUM>, and the tip end <NUM> of the second member <NUM> projecting a short distance (e.g., approximately <NUM>) below the tip end <NUM> of the third member <NUM>.

The surgeon may then push down on the head end <NUM> of the first (i.e., pilot) member <NUM> of the assembly, causing the tip end of <NUM> of the first member <NUM> to enter a small, previously-made incision <NUM> in the patient's skin and create a pilot hole within the patient's body. As the first member <NUM> advances, the head end <NUM> of the first member <NUM> pushes down on and "captures" the second and third members <NUM> and <NUM> of the assembly, causing all three members of the assembly to advance together. As the assembly <NUM> advances, the tip of the second member <NUM> enters the patient through the incision <NUM>. The tip end of the second member <NUM> follows behind the first member <NUM> and may partially dilate the pilot hole created by the first member <NUM> as the assembly <NUM> continues to advance into the patient, as shown in <FIG>.

In <FIG>, the first (i.e., pilot) member <NUM> of the multi-stage dilator and cannula assembly <NUM> is advanced until it reaches a target position within the patient's body. The target position may be a particular portion of the patient's spine, such as a surface of a vertebral bone. In embodiments, the first member <NUM> may be guided to the target position using an image guided surgery system. For example, one or more diagnostic images of the patient's anatomy may be obtained pre-operatively or intra-operatively using an imaging device (e.g., an x-ray CT or fluoroscopic imaging system, an MRI system, an ultrasound imaging system, etc.). The diagnostic image(s) may be registered to the coordinate space of a motion tracking system using known surgical navigation techniques. Thus, by tracking the position and/or orientation of instruments within the surgical area, the position of the instruments relative to anatomic features in the diagnostic image(s) may be determined. For example, the marker device <NUM> may be used to track the motion of the multi-stage dilator and cannula assembly <NUM> as the first member <NUM> is advanced into the patient. Based on the tracked movement and known geometry of the assembly <NUM>, the image guided surgery system may be used to determine when the tip of the first member <NUM> is located at a target position in the patient's body.

When the first (i.e., pilot) member <NUM> of the multi-stage dilator and cannula assembly <NUM> has reached the target position within the patient's body, the surgeon may then push down on the head end <NUM> of the second member <NUM> of the assembly, causing the second member <NUM> and third member <NUM> to continue to advance simultaneously into the patient's body while the first member <NUM> remains in place. The second member <NUM> continues to partially dilate the pilot hole, while the third member <NUM> provides additional dilation as the third member <NUM> is advanced into the patient's body.

In <FIG>, the second member <NUM> of the multi-stage dilator and cannula assembly <NUM> is advanced until it reaches the target position within the patient's body, such that the tip ends of the first (i.e., pilot) member <NUM> and the second member <NUM> are coincident proximate to the target position. In embodiments, the second member <NUM> may be guided to the target position using an image guided surgery system as described above. For example, the marker device <NUM> may be tracked by the motion tracking system as the second and third members <NUM> and <NUM> are advanced into the patient. The image guided surgery system may be used to determine when the tip of the second member <NUM> is located at the target position based on the detected motion of the marker device <NUM> and the known geometry of the assembly <NUM>.

The surgeon may then push down on the head end <NUM> of the third member <NUM> of the assembly, causing the third member <NUM> to advance further into the patient's body while the first member <NUM> and the second member <NUM> remain in place. The third member <NUM> may fully dilate the pilot hole as the third member <NUM> is advanced to the target position in the patient's body.

In <FIG>, the third member <NUM> of the multi-stage dilator and cannula assembly <NUM> is advanced until it reaches the target position within the patient's body, such that the tip ends of the first, second and third members are all coincident proximate to the target position. In embodiments, the third member <NUM> may be guided to the target position using an image guided surgery system as described above. For example, the marker device <NUM> may be tracked by the motion tracking system as the third member <NUM> is advanced into the patient. The image guided surgery system may be used to determine when the tip of the third member <NUM> is located at the target position based on the detected motion of the marker device <NUM> and the known geometry of the assembly <NUM>.

In <FIG>, the first (i.e., pilot) member <NUM> of the multi-stage dilator and cannula assembly <NUM> may be removed from the assembly <NUM> by sliding the first member <NUM> up and out through the opening <NUM> in the second member <NUM>. The opening <NUM> of the second member <NUM> may thus provide an open portal or passageway to the target position in the patient's body. The opening <NUM> may be sized to enable the surgeon to insert one or more invasive surgical tools (e.g., a drill bit, a screw, a needle, a cannula, a tool for gripping or cutting, an electrode, an implant, a radiation source, a drug and an endoscope) through the opening <NUM> to the target position. For example, the opening <NUM> may be used to guide a drill bit to the surface of the patient's bone, such as a vertebral bone, where the surgeon may use the drill bit to form a pilot hole in the bone for the subsequent insertion of a screw (e.g., a pedicle screw) or other implant. In one non-limiting embodiment, the opening <NUM> in the second member <NUM> may have a diameter of approximately <NUM> (e.g., <NUM>-<NUM>). The one or more surgical tools may then be removed from the opening <NUM>.

In <FIG>, the second member <NUM> of the multi-stage dilator and cannula assembly <NUM> may be removed from the assembly <NUM> by sliding the second member <NUM> up and out through the opening <NUM> in the third member <NUM>. The opening <NUM> in the third member <NUM> may be larger than the opening <NUM> in the second member <NUM>, and may thus provide an enlarged portal or passageway to the target position in the patient's body. The opening <NUM> may enable the surgeon to insert one or more additional surgical tools (e.g., a drill bit, a screw, a needle, a cannula, a tool for gripping or cutting, an electrode, an implant, a radiation source, a drug and an endoscope) to reach the target position. The one or more additional surgical tools inserted through opening <NUM> may optionally be larger than the surgical tool(s) inserted through opening <NUM>. For example, the opening <NUM> may be used to guide a screw (e.g., a pedicle screw) and screw driver or another implant or tool down to the surface of the patient's bone, where the surgeon may insert the screw into the patient's bone using the previously-drilled pilot hole in the bone. In one non-limiting embodiment, the opening <NUM> in the second member <NUM> may have a diameter of approximately <NUM> (e.g., <NUM>-<NUM>). The one or more additional surgical tools may then be removed from the opening <NUM>.

The third member <NUM> of the multi-stage dilator and cannula assembly <NUM> may then be removed from the patient's body. The assembly <NUM> may then be reassembled by inserting the first and second members <NUM>, <NUM> into the third member <NUM>. Optionally, the end effector/holding mechanism <NUM> may be moved to another location above the patient's body and the process may be repeated.

<FIG> illustrates a system <NUM> for performing robotically-assisted image-guided surgery using a multi-stage dilator and cannula assembly <NUM> according to various embodiments. The system <NUM> in this embodiment includes a robotic arm <NUM>, an imaging device <NUM> and a motion tracking system <NUM>. The robotic arm <NUM> may comprise a multi joint arm that includes a plurality of linkages connected by joints having actuator(s) and optional encoder(s) to enable the linkages to bend, rotate and/or translate relative to one another in response to control signals from a robot control system. The robotic arm <NUM> may be fixed to a support structure at one end and may have an end effector <NUM> at the other end of the robotic arm <NUM>. A multi-stage dilator and cannula assembly <NUM> is supported by the end effector <NUM>, as described above with reference to <FIG>.

The imaging device <NUM> may be used to obtain diagnostic images of a patient <NUM>, which may be a human or animal patient. In embodiments, the imaging device <NUM> may be an x-ray computed tomography (CT) imaging device. The patient <NUM> may be positioned within a central bore <NUM> of the imaging device <NUM> and an x-ray source and detector may be rotated around the bore <NUM> to obtain x-ray image data (e.g., raw x-ray projection data) of the patient <NUM>. The collected image data may be processed using a suitable processor (e.g., computer) to perform a three-dimensional reconstruction of the object. In other embodiments, the imaging device <NUM> may comprise one or more of an x-ray fluoroscopic imaging device, a magnetic resonance (MR) imaging device, a positron emission tomography (PET) imaging device, a single-photon emission computed tomography (SPECT), or an ultrasound imaging device. In embodiments, image data may be obtained pre-operatively (i.e., prior to performing a surgical procedure) or intra-operatively (i.e., during a surgical procedure) by positioning the patient <NUM> within the bore <NUM> of the imaging device <NUM>. In the system <NUM> of <FIG>, this may be accomplished by moving the imaging device <NUM> over the patient <NUM> to perform a scan while the patient <NUM> may remain stationary.

The motion tracking system <NUM> in this embodiment includes a plurality of marker devices <NUM>, <NUM> and <NUM> and a stereoscopic optical sensor device <NUM> that includes two or more cameras (e.g., IR cameras). The optical sensor device <NUM> may include one or more IR sources (e.g., diode ring(s)) that direct radiation (e.g., IR radiation) into the surgical field, where the radiation may be reflected by the marker devices <NUM>, <NUM> and <NUM> and received by the cameras. A computer <NUM> may be coupled to the sensor device <NUM> and may determine the positions and orientations of the marker devices <NUM>, <NUM>, <NUM> detected by the cameras using, for example, triangulation techniques. A 3D model of the surgical space may be generated and continually updated using motion tracking software implemented by the computer <NUM>. In embodiments, the computer <NUM> may also receive image data from the imaging device <NUM> and may register the image data to a common coordinate system with the motion tracking system <NUM> using image registration techniques as are known in the art. In embodiments, a reference marker device <NUM> (e.g., reference arc) may be rigidly attached to a landmark in the anatomical region of interest (e.g., clamped or otherwise attached to the spinous process of a patient's vertebrae) to enable the anatomical region of interest to be continually tracked by the motion tracking system <NUM>. Another marker device <NUM> may be rigidly attached to the robotic arm <NUM>, such as on the end effector <NUM> of the robotic arm <NUM>, to enable the position of robotic arm <NUM> and end effector <NUM> to be tracked using the motion tracking system <NUM>. The computer <NUM> may include software configured to perform a transform between the joint coordinates of the robotic arm <NUM> and the common coordinate system of the motion tracking system <NUM>, which may enable the position and orientation of the end effector <NUM> of the robotic arm <NUM> to be controlled with respect to the patient <NUM>.

The system <NUM> may also include a display device <NUM> as schematically illustrated in <FIG>. The display device <NUM> may display image data of the patient's anatomy obtained by the imaging device <NUM>. The display device <NUM> may facilitate planning for a surgical procedure, such as by enabling a surgeon to define one or more target positions in the patient's body and/or a path or trajectory into the patient's body for inserting surgical tool(s) to reach a target position while minimizing damage to other tissue or organs of the patient. The position and/or orientation of one or more objects tracked by the motion tracking system <NUM> may be shown on the display <NUM>, and may be shown overlaying the image data. For example, the position and/or orientation of a multi-stage dilator and cannula assembly <NUM> with respect to the patient's anatomy may be graphically depicted on the display <NUM> based on the tracked position/orientation of the marker device <NUM> fixed to the assembly <NUM> and the known geometry of the assembly <NUM>, which may be pre-registered with the motion tracking system <NUM>.

<FIG> is a process flow diagram that illustrates a method <NUM> for performing a robotically-assisted image-guided surgical procedure using a multi-stage dilator and cannula assembly <NUM> according to one embodiment. The multi-stage dilator and cannula assembly <NUM> may include a plurality of elongated members in a nested configuration, as described above with reference to <FIG>. The method <NUM> may be performed using a system <NUM> as described above with reference to <FIG>.

In step <NUM> of method <NUM>, a multi-stage dilator and cannula assembly <NUM> may be positioned over a patient. The assembly <NUM> includes a plurality of elongated members in a nested configuration, including a central member and at least one additional member located radially outward of the central member. In various embodiments, the multi-stage dilator and cannula assembly <NUM> may be secured to an end effector of a robotic arm. The robotic arm may move the end effector to a position and orientation such that the multi-stage dilator and cannula assembly <NUM> may be inserted into the patient's body and advanced to a pre-determined target position in the patient's anatomy. The target position may be defined by a surgeon using image data obtained from an imaging device, as described above.

In step <NUM> of method <NUM>, the surgeon may be prompted to push down on a first end of the central member of the multi-stage dilator and cannula assembly to advance the central member and at least one additional member located radially outward of the central member towards the pre-determined target position. The surgeon may be prompted via instructions provided on a display device, such as the display device <NUM> illustrated in <FIG>, and/or by another perceptible means, such as by an audible instruction.

In step <NUM>, the movement of the multi-stage dilator and cannula assembly may be tracked using a motion tracking system as the assembly is advanced towards the pre-determined target position. In step <NUM>, an indication that the tip end of the central member of the assembly is proximate to (e.g., within <NUM> of, such as within about <NUM> of) the pre-determined target position may be provided.

In step <NUM>, the surgeon may be prompted to push down on the next (i.e., adjacent) member of the assembly that is located radially outward from the central member. In step <NUM>, the movement of the assembly may be tracked and in step <NUM>, an indication that the tip end of the next member is proximate to the pre-determined target position may be provided.

In response to determining that there is at least one additional member in the assembly (i.e., determination block <NUM>= "Yes"), then steps <NUM> through <NUM> may be repeated for each member of the nested assembly until the tip end of the outermost member of the assembly is advanced proximate to the pre-determined target position.

In response to determining that there are no additional members of the assembly (i.e., determination block <NUM> = "No"), then in step <NUM> at least one member of the assembly may be removed from the outermost member to provide an open passageway to the pre-determined target position.

In various embodiments, the nested members of the multi-stage dilator and cannula assembly may be advanced to the target position in a simple and virtually continuous motion. As the assembly is advanced, it may provide progressive dilation of an opening in the patient's tissue to a desired target depth. The various members may then be selectively removed from the assembly to provide open passageways or cannula openings having different dimensions (e.g., diameters) for performing various steps of a surgical procedure. Following the surgical procedure, the outermost member of the assembly may be removed. The robotic arm may optionally move the end effector and the multi-stage dilator and cannula assembly to another location over the patient to perform a subsequent surgical procedure.

<FIG> schematically illustrate a method and system for performing a robot-assisted surgical procedure. The surgical procedure may be a spinal surgical procedure, such as a surgical procedure performed on the cervical spine (e.g., vertebrae C1-C7). The surgical procedure may be a minimally-invasive percutaneous surgical procedure, such as a minimally invasive cervical posterior fusion. It will be understood that other types of surgical procedures, such as thoracic or lumbar spinal procedures, could be performed using the systems and methods of the various embodiments.

<FIG> illustrates an end effector <NUM> of a robotic arm (not illustrated) positioned over a pre-determined target trajectory <NUM>. The end effector <NUM> may include a marker device <NUM> that enables the end effector <NUM> to be tracked using a motion tracking system <NUM> as described above. Another tracking device <NUM> may be fixed to the patient <NUM>. For example, tracking device <NUM> may be attached to a bone of the patient proximate to the surgical area, such as by clamping the tracking device <NUM> to the spinous process of a nearby vertebral level. Additional marker devices may be fixed to various tools used during the surgical procedure, as described further below. Each of the tools and their corresponding marker devices may be pre-registered and calibrated within a surgical navigation/image guided surgery system. Alternately or in addition, tools may be registered and calibrated by the navigation/image guided surgery system during the course of a surgical procedure. By continuously tracking the end effector <NUM>, surgical tools and patient marker device <NUM> using the motion tracking system <NUM>, each of the tracked objects may be located in three-dimensional space within a common coordinate system. In embodiments, the common coordinate system may have an origin or zero point that may be considered to be fixed relative to the surgically-relevant portion of the patient's anatomy (e.g., based on the tracked position/orientation of patient marker device <NUM>), and may also be referred to the patient coordinate system.

The end effector <NUM> may include a tool holder portion <NUM> (e.g., a hollow tube) that is configured to hold a tool. The trajectory <NUM> may be defined by the surgeon during surgical planning based on pre-operative patient images (e.g., x-ray CT or fluoroscopic images, MR images, etc.). The patient images and the pre-defined trajectory may be registered or synced within the same coordinate system (e.g., the patient coordinate system) as the end effector <NUM> of the robotic arm. The robotic arm may be controlled to move the end effector <NUM> such that the central axis of the tool holder portion <NUM> of the end effector <NUM> is aligned with the defined trajectory <NUM> as shown in <FIG>. Alternately, a target location may be defined based on the patient images and the end effector <NUM> may be moved such that the central axis of the tool holder portion <NUM> intersects the target location. The robotic arm may be controlled so as to hold the trajectory defined by the end effector during a portion of the surgical procedure, such as the insertion of a surgical implant (e.g., a pedicle screw) in a target location in the patient's anatomy.

The surgeon may make a small incision through the skin of the patient overlaying the target location.

As shown in <FIG>, a dilator <NUM> may be provided within the tool holder portion <NUM> of the end effector <NUM>. The dilator <NUM> have an outer diameter that substantially corresponds with the inner diameter of the tool holder portion <NUM>. The dilator <NUM> may be slidable within the tool holder portion <NUM>. The dilator <NUM> may include an opening <NUM> extending lengthwise through the dilator <NUM> as shown in <FIG>. The opening <NUM> may be configured to receive one or more tools, such as tool <NUM> shown in <FIG>.

In some embodiments, the dilator <NUM> may be a multi-stage dilator and cannula assembly <NUM> including a plurality of nested members, as described above with reference to <FIG>. Alternately, the dilator <NUM> may comprise a single member as shown in <FIG>. The dilator <NUM> may include a handle portion <NUM> to enable the dilator to be grasped and manipulated by a surgeon. The dilator <NUM> may optionally include a marker device (not shown for clarity) to enable the dilator <NUM> to be tracked using the motion tracking system <NUM>.

Also shown in <FIG> is a tool <NUM> inserted through the opening <NUM> in the dilator <NUM>. The tool <NUM> may be an awl or similar device (e.g., a needle) having a narrow pointed tip end <NUM>, a relatively wider collar portion <NUM>, and a handle <NUM>. The collar portion <NUM> may have an outer diameter that substantially corresponds with the diameter of the opening <NUM> of the dilator <NUM>. The tool <NUM> may be slidable within the dilator <NUM>. The tool <NUM> may also include a marker device <NUM> fixed to the tool <NUM> to enable the tool <NUM> to be tracked using the motion tracking system <NUM>. The tool <NUM> may be registered and calibrated within the surgical navigation/image guided surgery system such that the position and/or orientation of the tip end <NUM> of the tool <NUM> may be known within the patient coordinate system based on the tracked position and/or orientation of the marker device <NUM>.

In <FIG>, the surgeon may push down on the handle <NUM> of the tool <NUM> to advance the tip end <NUM> of the tool <NUM> through the incision in the patient's skin and into the patient's body. The end effector <NUM> and cannula <NUM> may guide the movement of the tool <NUM> as the collar portion <NUM> slides within the opening <NUM> of the cannula <NUM> such that the tip end <NUM> of the tool <NUM> advances along the trajectory to the target position within the patient. In embodiments, the surgeon may be prompted to push down on the tool <NUM> via instructions provided on a display device, such as the display device <NUM> illustrated in <FIG>, and/or by another perceptible means, such as by an audible instruction. The movement of the tool <NUM> may be tracked by the motion tracking system <NUM> as the tip end <NUM> is advanced towards the pre-determined target position. An indication that the tip end <NUM> of the tool is proximate to (e.g., within <NUM> of, such as within about <NUM> of) the pre-determined target position may also be provided.

<FIG> illustrates the tool <NUM> pushed down such that the tip end <NUM> contacts a bone <NUM> surface of the patient <NUM>. In some embodiments, the surgeon may continue to push down on the tool <NUM> such that the tip end <NUM> may break the cortical surface and create a preliminary pilot hole in the bone <NUM>. Alternately, the surgeon may remove the tool <NUM> from the dilator <NUM> and may use another tool (e.g., a Jamshidi needle) for this purpose.

Alternately, the tool <NUM> having a pointed tip end <NUM> may be integrated with a multi-stage dilator and cannula assembly <NUM>, such as described above with reference to <FIG>. In various embodiments, the first (i.e., pilot) member <NUM> of the multi-stage dilator and cannula assembly <NUM> may have a narrow pointed tip end <NUM>, as with the tool <NUM> shown in <FIG>. Pushing down on the on the pilot member <NUM> may cause the pointed tip end <NUM> to advance into the patient while also capturing and advancing one or more outer stages of the dilator into the patient, as described above. In embodiments, the integrated tool and dilator assembly may be calibrated and registered with the image guided surgery system, such that the position of the tip end <NUM> of the tool <NUM> may be known based on the tracked position of a marker fixed to the dilator assembly.

In <FIG>, the dilator <NUM> may be pushed down relative to the end effector <NUM> to advance the dilator <NUM> into the patient <NUM> and to dilate the opening previously made by one or more other tools (e.g., tool <NUM>). As shown in <FIG>, the dilator <NUM> may be pushed down over the tool <NUM>. Alternately, the tool <NUM> may be removed from the dilator <NUM> before the dilator <NUM> is pushed down. The dilator <NUM> may be advanced into the patient <NUM> until the tip end <NUM> of the dilator <NUM> docks against the bone <NUM> surface, as shown in <FIG>. In some embodiments, the tip end <NUM> of the dilator <NUM> may be angled or contoured to facilitate mating with the bone <NUM>. In embodiments, the tip end <NUM> may include cleats or other features to dig into and/or grip the bone surface.

In embodiments, the surgeon may be prompted to push down on the dilator <NUM> via instructions provided on a display device, such as the display device <NUM> illustrated in <FIG>, and/or by another perceptible means, such as by an audible instruction. In embodiments where the dilator <NUM> is tracked, the movement of the dilator <NUM> may be tracked by the motion tracking system <NUM> and displayed on a display device as the dilator <NUM> is advanced towards the bone <NUM>. For a multi-stage dilator, each nested cannula may be advanced to the bone <NUM> to provide progressive dilation of the surgical opening.

When the dilator <NUM> is docked against the bone <NUM>, the tool <NUM> (e.g., an awl) may be removed from the dilator <NUM>, leaving the opening <NUM> in the dilator <NUM> providing a port to the surface of the bone <NUM>. For a multi-stage dilator, one or more inner stages of the dilator may be removed to leave the dilator with an opening having a desired inner diameter. In embodiments of a multi-stage dilator, the inner diameter of each nested cannula may correspond with the outer diameter of particular tools and/or implants that are intended to be inserted through the cannula during the surgical procedure.

In <FIG>, a drill <NUM> is shown inserted through the opening <NUM> in the dilator <NUM>. The drill <NUM> may include a drill bit <NUM> at a tip end <NUM> of the drill, a collar portion <NUM>, and a handle <NUM>. The collar portion <NUM> may have an outer diameter that substantially corresponds with the diameter of the opening <NUM> of the dilator <NUM>. The drill <NUM> may also include a marker device <NUM> fixed to the drill <NUM> to enable the drill <NUM> to be tracked using the motion tracking system <NUM>. The drill <NUM> may be registered and calibrated within the surgical navigation/image guided surgery system such that the position and/or orientation of the tip end <NUM> of the drill <NUM> may be known within the patient coordinate system based on the tracked position and/or orientation of the marker device <NUM>.

The drill <NUM> may be used to create a pilot hole within the bone <NUM> for a surgical implant (e.g., a screw). The depth of the pilot hole may be tracked by the motion tracking system <NUM> (i.e., based on the position of the tip end <NUM> of the drill <NUM>) and an indication of the depth may be provided on the display device <NUM>. In some embodiments, the surgeon may be instructed to insert the drill <NUM> into the dilator <NUM> and may be prompted to use the drill <NUM> to create a pilot hole via instructions provided on the display device <NUM>, and/or by another perceptible means, such as by an audible instruction. An indication that the pilot hole has reached a pre-determined depth may also be provided. After the pilot hole is created, the drill <NUM> may be removed from the dilator <NUM>.

In <FIG>, a screw <NUM> and screw driver <NUM> are shown inserted through the opening <NUM> in the dilator <NUM>. The screw <NUM> may include a threaded tip end <NUM> extending from a screw head <NUM>, and a tab portion <NUM> extending from the screw head <NUM> opposite the threaded tip end <NUM>. At least one of the tab portion <NUM> and the screw head <NUM> may include an outer diameter that substantially corresponds with the diameter of the opening <NUM> of the dilator <NUM>. This may enable the threaded tip end <NUM> of the screw <NUM> to align with a pilot hole created by a drill <NUM> as shown in <FIG>. The screw driver <NUM> may include a tip end <NUM> that is sized and shaped to engage with a corresponding portion of the screw <NUM> so as to enable the screw driver <NUM> to apply a torque to the screw <NUM>. The screw driver <NUM> may include features to enable the screw driver <NUM> to mate with the tab portion <NUM> of the screw <NUM> and may also include a collar <NUM> having an outer diameter that substantially corresponds with the diameter of the opening <NUM> of the dilator <NUM>.

The screw driver <NUM> may also include handle <NUM> to enable the screw driver <NUM> to be gripped and manipulated (e.g., rotated) by a surgeon. A marker device <NUM> may be fixed to the screw driver <NUM> to enable the screw driver <NUM> to be tracked using the motion tracking system <NUM>. In some embodiments, the screw driver <NUM> may be registered and calibrated within the surgical navigation/image guided surgery system such that the position and/or orientation of the tip of the screw driver <NUM> may be known within the patient coordinate system based on the tracked position and/or orientation of the marker device <NUM>. The offset distance between the tip of the screw driver <NUM> and the tip end of the screw <NUM> when the screw driver <NUM> engages the screw <NUM> may also be calibrated to enable the depth of the screw within the patient's bone <NUM> to be determined. A graphical depiction of the screw <NUM> and its position within the patient may be shown overlaying the patient images on the display device <NUM>.

The screw driver <NUM> may be used to insert the screw <NUM> within the bone <NUM>. The depth of the insertion may be tracked by the motion tracking system <NUM> (i.e., based on the position of the tip of the screw driver <NUM> and/or the rotational displacement of the screw driver <NUM> as the screw driver <NUM> screws the screw <NUM> into the bone <NUM>). An indication of the depth of screw insertion may be provided on the display device <NUM>. In some embodiments, the surgeon may be instructed to insert the screw <NUM> and screw driver <NUM> into the dilator <NUM> and may be prompted to use the screw driver <NUM> to insert the screw <NUM> via instructions provided on the display device <NUM>, and/or by another perceptible means, such as by an audible instruction. An indication that the screw <NUM> has been inserted to a pre-determined depth may also be provided.

After the screw <NUM> has been inserted into the bone <NUM>, the screw driver <NUM> may be removed from the dilator <NUM>. The dilator <NUM> may then be slid upwards within the end effector <NUM> over the screw <NUM> and out of the patient <NUM>, as shown in <FIG>. The screw <NUM> may remain fixed to the bone <NUM>, with a portion of the tab portion <NUM> extending outside of the patient <NUM>.

After a screw <NUM> has been placed in the patient <NUM>, the robotic arm may optionally move the end effector <NUM> to a next target position/trajectory over the patient <NUM>, and the above-described process may be repeated for the insertion of another screw <NUM>.

In embodiments, the positions of each screw <NUM> within the patient coordinate system may be saved within the surgical navigation/image guided surgery system, which may facilitate rod placement, including the curvature and/or insertion pathway for one or more rods. In embodiments, the tab portions <NUM> of the screws <NUM> may be used to secure the rods (such as by inserting and/or tightening a set screw or other fastening mechanism against a rod through the tab portions <NUM>). The tab portions <NUM> may then be removed (e.g., using tab breakers), leaving the rest of the screw <NUM> in place.

<FIG> is a system block diagram of a computing device useful to perform functions of a processing control unit, such as computer <NUM> described above with reference to <FIG>. While the computing device <NUM> is illustrated as a laptop computer, a computing device providing the functional capabilities of the computer device <NUM> may be implemented as a workstation computer, an embedded computer, a server computer, a desktop computer or a handheld computer (e.g., tablet, a smartphone, etc.). A typical computing device <NUM> may include a processor <NUM> coupled to an electronic display <NUM>, a speaker <NUM> and a memory <NUM>, which may be a volatile memory as well as a nonvolatile memory (e.g., a disk drive). When implemented as a laptop computer or desktop computer, the computing device <NUM> may also include a floppy disc drive, compact disc (CD) or DVD disc drive coupled to the processor <NUM>. The computing device <NUM> may include an antenna <NUM>, a multimedia receiver <NUM>, a transceiver <NUM> and/or communications circuitry coupled to the processor <NUM> for sending and receiving electromagnetic radiation, connecting to a wireless data link, and receiving data. Additionally, the computing device <NUM> may include network access ports <NUM> coupled to the processor <NUM> for establishing data connections with a network (e.g., LAN coupled to a service provider network, etc.). A laptop, desktop or workstation computer <NUM> typically also includes a keyboard <NUM> and a mouse pad <NUM> for receiving user inputs.

The foregoing method descriptions are provided merely as illustrative examples and are not intended to require or imply that the steps of the various embodiments must be performed in the order presented. Words such as "thereafter," "then," "next," etc. are not necessarily intended to limit the order of the steps; these words may be used to guide the reader through the description of the methods.

In one or more exemplary aspects, the functions described may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on as one or more instructions or code on a non-transitory computer-readable medium. The steps of a method or algorithm disclosed herein may be embodied in a processor-executable software module executed which may reside on a non-transitory computer-readable medium. Non-transitory computer-readable media includes computer storage media that facilitates transfer of a computer program from one place to another. By way of example, and not limitation, such non-transitory computer-readable storage media may comprise RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that may be used to carry or store desired program code in the form of instructions or data structures and that may be accessed by a computer. Disk and disc, as used herein, includes compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk, and blu-ray disc where disks usually reproduce data magnetically, while discs reproduce data optically with lasers. Combinations of the above should also be included within the scope of non-transitory computer-readable storage media. Additionally, the operations of a method or algorithm may reside as one or any combination or set of codes and/or instructions on a machine readable medium and/or computer-readable medium, which may be incorporated into a computer program product.

Claim 1:
A multi-stage dilator and cannula assembly (<NUM>), comprising:
a plurality of elongated members (<NUM>, <NUM>, <NUM>) in a nested configuration that are slidable relative to one another along a central axis (a), each member (<NUM>, <NUM>, <NUM>) having a length dimension between a head end (<NUM>) and a tip end (<NUM>) of the member (<NUM>, <NUM>, <NUM>), and each successive member (<NUM>, <NUM>) of the plurality of members (<NUM>, <NUM>, <NUM>) extending radially outward from a central member (<NUM>) has a larger outer dimension and a shorter length dimension than the preceding member (<NUM>, <NUM>), wherein the central member (<NUM>) is a first member of the plurality of elongated members (<NUM>, <NUM>, <NUM>), and the plurality of elongated members (<NUM>, <NUM>, <NUM>) further includes successive second and third members (<NUM>, <NUM>), each of the plurality of elongated members (<NUM>, <NUM>, <NUM>) includes at least one feature located proximate the head end (<NUM>) of the member (<NUM>, <NUM> , <NUM>) enabling a user to grip and manipulate the members (<NUM>, <NUM>, <NUM>), with the first member (<NUM>) including a handle (<NUM>) at the head end (<NUM>), and each of the second and third members (<NUM>, <NUM>) including a flange (<NUM>, <NUM>) at the head end (<NUM>), respectively, the flange (<NUM>, <NUM>) extending transverse to the length extension of the member (<NUM>, <NUM>),
characterized in that
the third member (<NUM>) further includes a c-shaped protrusion (<NUM>) extending from its flange (<NUM>) in the direction of the handle (<NUM>) of the first member (<NUM>), said protrusion (<NUM>) allowing the user to grasp and hold the entire assembly (<NUM>).