Patent Description:
Some example embodiments described herein relate to surgical robotics, and in particular to control of medical instruments which have an insertion action, such as a biopsy needle or ablation tool.

Cancer diagnosis and treatment can require the medical practitioner to be able to pin point a suspicious lesion within the patient. After the area is located, the next step in a typical treatment process can include a biopsy procedure to identify the pathology, which can be performed in the operating room, with the patient under general anesthetic. In other instances, biopsy procedures can include the implementation of core needle biopsy procedures using minimally invasive core needle extraction methods.

Difficulties can arise in performing of a conventional procedure. As an example, for breast biopsy with magnetic resonance imaging (MRI) systems, the patient may have to be shuttled in and out of the magnet several times before a biopsy is actually performed. During this time, the contrast agent could have already lost some of its effect and image quality could suffer. This process itself may be time consuming and cumbersome, especially in a time-sensitive environment.

In addition, contrast laden blood from a hematoma as well as an air pocket at the biopsy site can make it difficult to subsequently verify that the correct site identified from the imaging system was biopsied, or to rapidly confirm that the sample obtained has a suspect morphology. This practice could also require removal of a relatively large volume of tissue, with a fraction of that assumed to be from the lesion. Documents <CIT>, <CIT> and <CIT> disclose relevant background art.

It would be advantageous to provide a medical insertion device which may be used within an imaging system in real-time or near real-time.

Example embodiments relate to a medical insertion device which may be used with or installed within an imaging system, such as a magnetic resonance imaging (MRI) system to plan the best approach to the target tissue. The medical insertion device can generally be used to retain, position and effect insertion of a medical instrument, for example a biopsy device or an ablation treatment device. The device can generally provide linear, rotational and/or angular degrees of freedom for positioning of the medical instrument prior to an insertion of the medical instrument. Embodiments include performance in real-time imaging environment (i.e. "in-bore" imaging). Additional embodiments include data/software integration into the system, allowing a user to pull images taken and employ a 2D or 3D target planning algorithm to provide coordinates for device positioning.

In an example embodiment, there is provided a robotic system, including an insertion device having an interface for interfacing with a medical instrument, one or more mechanisms for effecting insertion of the medical instrument or a part of the medical instrument in an insertion direction, and for effecting pitch and yaw of the insertion device, and a controller in communication with the detector subsystem and configured to automatically control the one or more mechanisms based on the received spatial information.

In another example embodiment, there is provided a medical insertion device which includes a mounting arm, an interface connected to the mounting arm for interfacing with a medical instrument, a mechanism for movement of the medical instrument or a part of the medical instrument in an insertion direction, a carriage connected to a distal end of the mounting arm, and a pivot connection between the carriage and the distal end of the mounting arm to permit pitch or yaw of the mounting arm.

In another example embodiment, there is provided a method for facilitating insertion of a medical instrument, which includes: interfacing the medical instrument with an interface, the interface being connected to a mounting arm, pivoting the mounting arm at a pivot connection connected between a carriage and a distal end of the mounting arm to effect pitch or yaw of the mounting arm, and moving the medical instrument or a part of the medical instrument in an insertion direction.

In another example embodiment, there is provided a dispenser system for use with an imaging system, which includes a dispenser frame adjoined to the imaging system, the dispenser frame including or defining at least one instrument holder for holding and releasably providing of a medical instrument.

Reference will now be made, by way of example, to the accompanying drawings which show example embodiments, and in which:.

Similar reference numerals may be used in different figures to denote similar components.

Cancer diagnosis or procedures can include using a biopsy tool to retrieve a tissue sample for further analysis. A difficulty with some existing medical systems is that the health practitioner may not be able to work within a CT or MRI system during scanning for procedures such as biopsy or ablation therapy.

Many imaging systems may also have limited space constraints for placement of robotic systems.

Some example embodiments relate to an image guided, automated surgical robotic system having a manipulator, and associated workstations for the purpose of obtaining a biopsy sample and/or treating an identified lesion/pathology. The system can interface with existing clinical diagnostic imaging systems such as magnetic resonance imaging (MRI) to help chose a specific target and then automatically or semi-automatically drive a medical instrument such as a percutaneous coring needle biopsy device or ablation tool, under real-time or near-real-time image guidance.

In an example embodiment, there is provided a robotic system, including an insertion device having an interface for interfacing with a medical instrument, one or more mechanisms for effecting insertion of the medical instrument or a part of the medical instrument in an insertion direction, and for effecting pitch and yaw of the insertion device, a detector subsystem for determining spatial information, and a controller in communication with the detector subsystem and configured to automatically control the one or more mechanisms based on the received spatial information.

In another example embodiment, there is provided a method for facilitating insertion of a medical instrument, or the use of the medical instrument, which includes: interfacing the medical instrument with an interface, the interface being connected to a mounting arm, pivoting the mounting arm at a pivot connection connected between a carriage and a distal end of the mounting arm to effect pitch or yaw of the mounting arm, and moving the medical instrument or a part of the medical instrument in an insertion direction.

Reference is first made to <FIG> and <FIG>, which show a medical insertion device <NUM> in accordance with an example embodiment. Generally, the medical insertion device <NUM> may be used with or installed within an imaging system (not shown here), such as a magnetic resonance imaging (MRI) system, during scanning. The medical insertion device <NUM> can generally be used to retain, position and effect insertion of a medical instrument <NUM>, for example a biopsy device <NUM> as shown, or for example a treatment device. The device <NUM> can generally provide linear, angular and/or rotational degrees of freedom for positioning of the medical instrument <NUM> prior to insertion of the medical instrument <NUM>.

As shown in <FIG>, the medical insertion device <NUM> includes a frame <NUM> which acts to house the medical insertion device <NUM>. The medical insertion device <NUM> further includes a linear slide assembly <NUM> mounted or connected to the frame <NUM>. The medical insertion device further includes a rotary drive assembly <NUM> for generally driving the linear slide assembly <NUM>, and a carriage assembly <NUM> for moving along the linear slide assembly <NUM>. The carriage assembly <NUM> also generally supports the medical instrument <NUM> for positioning and insertion thereof.

Referring still to <FIG>, the frame <NUM> will now be described in greater detail. The frame <NUM> includes a baseplate <NUM> and a drive support plate <NUM> connected thereto to at least partially form a housing of the medical insertion device <NUM>. Other sidewalls or plates (not shown) may also form part of the frame <NUM>. The frame <NUM> also includes a drive plate strengthening bracket <NUM> for strengthening of the connection between the baseplate <NUM> and the drive support plate <NUM>. Other strengthening brackets (not shown) may also be used. The baseplate <NUM> may also include alignment fiducials <NUM> or other alignment markers for correlating the physical world with an imaging system (not shown here). An additional alignment fiducial 113a or fiducials may be placed on the elongate mounting arm <NUM> (e.g. device holder <NUM>), or on the medical instrument <NUM> itself (not shown), for correlating or registration purposes. In some example embodiments, the alignment fiducials can include MR molecular tagging. In some example embodiments, the frame <NUM> encloses almost an entirety of the medical insertion device <NUM>, save for the frame <NUM> further including or defining an opening at the front for passage of the medical instrument <NUM> there through. In yet further embodiments, the frame <NUM> is integrated into or forms part of a same frame (not shown here) of the particular imaging system (not shown here). The frame <NUM> can be panel shaped to fit within restricted environments having a limited height.

Referring still to <FIG>, the carriage assembly <NUM> includes an elongate mounting arm <NUM>, wherein the mounting arm <NUM> includes an insertion track <NUM> which runs along a length of the mounting arm <NUM>. An insertion carriage <NUM> includes a mechanism such as a pneumatic or piezoelectric motor which can move or step the carriage <NUM> along the insertion track <NUM>. The insertion carriage <NUM> is therefore slideably mounted to the insertion track <NUM>. A device holder <NUM> is connected to the carriage <NUM>. The device holder <NUM> is generally tubular shaped and acts as an interface to receive or interface with the medical instrument <NUM>. As shown in <FIG>, the device holder <NUM> includes a sheath to receive a corresponding tubular-shaped main body <NUM> of the medical instrument <NUM>. Thus, movement of the insertion carriage <NUM> along the insertion track <NUM> causes the medical instrument <NUM> to move in an insertion direction <NUM>. In the example shown, the mounting arm <NUM> also defines the insertion direction <NUM>. In some example embodiments, the mounting arm <NUM> and/or the device holder <NUM> includes a force sensor(s) to detect the tissue being penetrated, and for prevention of accidental excursion into the incorrect tissue (e.g. chest wall).

Referring still to <FIG>, the medical instrument <NUM> typically includes the main body <NUM> and an elongate member <NUM> such as a needle which extends from the main body <NUM>. In example embodiments, the elongate member <NUM> is formed from MR compatible materials such as carbon fibre, ceramic, or tritanium. One example of the medical instrument <NUM> is a biopsy tool <NUM>, such as a vacuum assisted biopsy (VAB) device available from ATEC (TM), as would be understood in the art. The elongate member <NUM> can also include an ablative tool such as Radio Frequency (RF) ablation, focused ultrasound, cryotherapy, laser and other ablative technologies that are administered within the cancerous region causing cell destruction with minimal damage to surrounding tissues. In some example embodiments, the medical instrument <NUM> may also include a detector such as a probe, ultrasound probe, or fiber optic probe. The detector can also include an MRI coil to provide higher resolution in situ imaging. In yet further example embodiments, the medical instrument <NUM> may be integrated with the device holder <NUM> to result in a dedicated-purpose insertion device. In yet further example embodiments, the medical instrument <NUM> can include an end effector or end effectors.

Reference is now made to <FIG>, which shows the medical instrument <NUM> in a retraction configuration or orientation. As shown, the insertion carriage <NUM> is located at a proximal end of the insertion track <NUM>, which therefore has retracted the medical instrument <NUM> backwards along the insertion direction <NUM> (with respect to <FIG>). From this position, the insertion carriage <NUM> can move along the insertion track <NUM> to the distal end of the insertion track <NUM>, resulting in the medical instrument <NUM> moving in the insertion direction <NUM> to an insertion configuration or orientation as shown in <FIG>.

In example embodiments, referring again to <FIG>, the carriage assembly <NUM> generally includes one or more carriages which including pivot connections and/or slideable connections for effecting positioning of the mounting arm <NUM>, and therefore positioning of the medical instrument <NUM>. Once at the desired position, the next step is typically an insertion step through the skin which includes movement of the insertion carriage <NUM> along the insertion track <NUM> in the insertion direction <NUM>.

In the example shown in <FIG>, the carriage assembly <NUM> includes a first carriage coupling <NUM> and a second carriage coupling <NUM>. The first carriage coupling <NUM> includes a first carriage <NUM> and a second carriage <NUM>. The second carriage coupling <NUM> includes a third carriage <NUM> and a fourth carriage <NUM>. As shown, the first carriage <NUM> via first sway arm <NUM> is connected to a distal end of the mounting arm <NUM> using a ball-and-socket pivot connection, which is defined by a ball <NUM> of the mounting arm <NUM> and a corresponding socket <NUM> of the first sway arm <NUM>. Such a pivot connection therefore permits pitch or yaw of the mounting arm <NUM> in operation. The first carriage <NUM> also itself includes a pivoting (e.g. hinged) connection <NUM> with the first sway arm <NUM> at the linear slide assembly <NUM>. The first sway arm <NUM> is also hingedly connected to a first coupling arm <NUM>. The first coupling arm <NUM> is hingedly connected to the second carriage <NUM>.

The third carriage <NUM> is connected to a proximal end of the mounting arm <NUM> via a second sway arm <NUM>, using a pivoting connection <NUM> such as a first hinge coupled with a second hinge, as shown. The second sway arm <NUM> is hingedly connected to a second coupling arm <NUM>. The second coupling arm <NUM> is hingedly connected to the fourth carriage <NUM>. The third carriage <NUM> also includes a pivoting (e.g. hinged) connection <NUM> to the second sway arm <NUM> at the linear slide assembly <NUM>.

Referring still to <FIG>, the linear slide assembly <NUM> provides a support for the carriage assembly <NUM>, and includes a first track system <NUM> and a second track system <NUM> having mechanisms for individually or collectively controlling of the positioning of the carriages <NUM>, <NUM>, <NUM>, <NUM>. As shown, the first track system <NUM> supports the first carriage coupling <NUM> and the second track system <NUM> supports the second carriage coupling <NUM>. The first and second track systems <NUM>, <NUM> include straightly moveable or slideable connections with the respective carriages <NUM>, <NUM>, <NUM>, <NUM> for facilitating linear translation of the carriages <NUM>, <NUM>, <NUM>, <NUM>.

Referring to the first track system <NUM>, this includes four rails 164a-d, which correspond respectively to channels 166a-d defined by the first carriage <NUM> and channels 168a-d defined by the second carriage <NUM>, as shown in <FIG>. In the example embodiment shown, first and fourth rails 164a and 164d are smooth rails which act as guide rails for sliding of the first carriage <NUM> and the second carriage <NUM>. Thus, channels 166a, 166d, 168a, and 168d may also have smooth inner surfaces. Second rail 164b includes a lengthwise screw thread definition which engages corresponding anti-backlash nut (not shown) within channel 166b of the first carriage <NUM>. Channel 168b of second carriage <NUM> has a smooth inner surface. Thus, rotation of second rail 164b results in horizontal translation of first carriage <NUM> while not affecting the second carriage <NUM>. Similarly, third rail 164c includes a lengthwise screw thread definition which engages corresponding anti-backlash nut (not shown) within channel 168c of the second carriage <NUM>. Channel 166c of first carriage <NUM> has a smooth inner surface. Thus, rotation of the third rail 164c results in horizontal translation of the second carriage <NUM> along the first rail system <NUM> while not affecting the first carriage <NUM>.

In example embodiments, a similar configuration may be used for the second track system <NUM>, which includes four rails 170a-d, which correspond respectively to channels 172a-d defined by the third carriage <NUM> and channels 174a-d defined by the fourth carriage <NUM>, as shown in <FIG>. In the example embodiment shown, first and fourth rails 170a and 170d are smooth rails which act as guide rails for sliding of the third carriage <NUM> and the second carriage <NUM>. Thus, channels 172a, 172d, 174a, and 174d may also have smooth inner surfaces. Second rail <NUM> includes a lengthwise screw thread definition which engages corresponding screw threads of channel 172b of the third carriage <NUM>. Channel 174b of fourth carriage <NUM> has a smooth inner surface. Thus, rotation of second rail 170b results in horizontal translation of third carriage <NUM> while not affecting the fourth carriage <NUM>. Similarly, third rail 170c includes a lengthwise screw thread definition which engages corresponding screw threads of channel 174c of the fourth carriage <NUM>. Channel 172c of third carriage <NUM> has a smooth inner surface. Thus, rotation of the third rail 170c results in horizontal translation of the fourth carriage <NUM> along the second rail system <NUM> while not affecting the third carriage <NUM>.

Referring still to <FIG>, reference is now made to the rotary drive assembly <NUM>, which acts to drive the various tracks of the linear slide assembly <NUM>, for driving of the various carriages <NUM>, <NUM>, <NUM>, <NUM> of the carriage assembly <NUM>. In the example embodiment shown, the rotary drive assembly <NUM> includes four rotary drive units 180a-d (each or individually referred to as <NUM>) each corresponding to a respective rotary drive belt 182a-d. As shown, rotary drive unit 180a is coupled to rail 164b, rotary drive unit 180b is coupled to rail 164c, rotary drive unit 180c is coupled to rail 170b, and rotary drive unit 180d is coupled to rail 170c.

Reference is now made to <FIG>, which show a rotary drive unit <NUM> in greater detail, in accordance with an example embodiment. As shown in <FIG>, the drive unit <NUM> includes, in sequential adjoining order, a pulley <NUM> for engaging the drive belt 182a-d, a retaining ring <NUM>, a ceramic bearing <NUM>, a front motor plate <NUM>, a ceramic ring <NUM>, a drive shaft <NUM>, a second ceramic ring <NUM>, a second ceramic bearing <NUM>, one or more spacer plates <NUM> (two shown), a back motor plate <NUM>, and a controller such as a microcontroller or encoder <NUM>. Four motors such as ultrasonic motors <NUM> can be used to drive the drive shaft <NUM>, which are controllable by the encoder <NUM>. An example suitable ultrasonic motor <NUM> is a HR2 motor by Nanomotion Ltd. , as would be understood in the art. In other example embodiments, vacuum-actuated drivers or hydraulic drivers may be used.

Referring still to <FIG>, various modes of operation of the medical insertion device <NUM> can be effected to position the medical instrument <NUM> by slideably moving at least one of the carriages <NUM>, <NUM>, <NUM>, <NUM>. For example, for each carriage coupling <NUM>, <NUM> the individual carriages may be moved so that relative motion (left or right) between two carriages will raise one end of the mounting arm <NUM> up or down, either linearly or in a slightly curved trajectory. The slightly curved trajectory also results in axial rotation of the medical instrument <NUM>. Translation of the two carriages couplings <NUM>, <NUM> in unison results in a linear translation left and right. A differential motion left and right between the first carriage coupling <NUM> and the second carriage coupling <NUM> results in a horizontal angular motion (yaw), while a differential vertical motion between the first carriage coupling <NUM> and the second carriage coupling <NUM> results in a vertical angle (pitch). Raising or lowering the first carriage coupling <NUM> and the second carriage coupling <NUM> in unison results in a combined vertical motion.

Reference is thus made to <FIG>, which show the medical insertion device <NUM> in a pitch up configuration. As shown, to effect the pitch up configuration, the first carriage <NUM> and the second carriage <NUM> are slideably moved relatively towards each other. In some embodiments, only one of the first carriage <NUM> and the second carriage <NUM> is moved towards the other, resulting in a slightly curved pitch up trajectory. This slightly curved trajectory also results in axial rotation of the medical instrument <NUM>. In another example embodiment (not shown), a pitch down may be effected by having the first carriage <NUM> and the second carriage <NUM> slideably moved relatively away from each other.

Reference is also made to <FIG>, which show the medical insertion device <NUM> in a straight insertion configuration. As shown, to effect the straight insertion configuration, at least one of the carriages <NUM>, <NUM>, <NUM>, <NUM> are slideably moved to cause the medical instrument <NUM> to be horizontally oriented, which would be rectilinear to the insertion target.

Reference is now made to <FIG>, which show the medical insertion device <NUM> in a translated configuration. As shown, all of the carriages <NUM>, <NUM>, <NUM>, <NUM> are slideably moved at the same displacement in a direction, for example left (as shown) or right.

Reference is now made to <FIG> and <FIG>, which show the medical insertion device <NUM> in a yaw configuration. As best shown in <FIG>, the carriages <NUM>, <NUM> of the second carriage coupling <NUM> can be collectively moved leftwardly relative to the first carriage coupling <NUM> to result in the medical instrument <NUM> being angled in a yaw right direction. Similarly, the carriages <NUM>, <NUM> of the second carriage coupling <NUM> can be collectively moved rightwardly relative to the first carriage coupling <NUM> to result in the medical instrument <NUM> being angled in a yaw left direction (not shown).

Referring again to <FIG>, it can be appreciated that the medical insertion device <NUM> can effect various insertion angles of the medical instrument <NUM> which vary from a straight insertion. It may be appreciated that the various insertion angles may provide flexibility in performing the particular procedure. Further, it may be appreciated that the medical insertion device <NUM> may provide a stable insertion angle for the subsequent insertion step. In addition, the medical instrument <NUM> may for example be able to reach additional target regions such as those near the edges of the frame <NUM> (e.g. at regions beyond the linear slide assembly <NUM> closer to the baseplate <NUM>).

It may also be appreciated that a difficulty with some existing conventional systems is that conventional articulated or snake-like robotic arms may not be able to provide the required stability or control for performing such a procedure within an imaging system, and especially for the final subcutaneous insertion step of the needle through the skin and tissue.

Referring again to <FIG>, in another mode of operation, it can be appreciated that the device holder <NUM> can be reversed, in that the body <NUM> of the medical instrument <NUM> can be inserted into the other opening <NUM> of the device holder <NUM>. For example, the configuration shown in <FIG> may be used for superior (from the head) insertion at the right breast in a "right side" configuration. The entire medical instrument <NUM> (e.g. the frame <NUM>) can then be reversed with the body <NUM> of the medical instrument <NUM> inserted into the other opening <NUM> of the device holder <NUM> for superior insertion at the left breast in a "left side" configuration. Of course, in the "left side" configuration the references herein to proximal and distal would be reversed. It may be appreciated that such a reversible configuration could provide operation of the device <NUM> in a limited space environment such as within an MRI (not shown here).

Suitable materials for the various described assemblies and subsystems of the device <NUM> include magnetic resonance (MR) compatible materials, ceramics, thermo-plastics and thermo-sets. Additional example materials may also include carbon fiber, ceramic, composites, nanoparticle composites, aluminium, titanium, and stainless steel. Examples of MR compatible motors include piezoelectric motors, pneumatic, vacuum-actuated drivers or hydraulic drivers.

Variations may be made to the device <NUM> in example embodiments. For example, in some example embodiment, an insertion mechanism may be used to move the entire linear slide assembly <NUM> in the insertion direction <NUM> to provide the insertion step (rather than from the insertion track <NUM>). In some additional embodiments, some medical instruments <NUM> may include their own insertion or injection mechanism, which may be automated or manually controlled. For example, in some example embodiments, only a part of the medical instrument <NUM> such as the elongate member <NUM> (e.g. a needle) is independently controllable by a mechanism for insertion.

Reference is now made to <FIG>, which shows a dispenser system <NUM> in accordance with an example embodiment. The dispenser system <NUM> can for example be used with an imaging system (not shown here) to dispense one or more medical instruments 302a-h (each or individually referred to as <NUM>) to the medical insertion device <NUM> (<FIG>). As shown, the dispenser system <NUM> includes a dispenser frame <NUM> which can be adjoined or attached to the particular imaging system. The dispenser frame <NUM> includes or defines a plurality of instrument holders 306a-h (each or individually referred to as <NUM>) for respectively holding the medical instruments 302a-h. The instrument holders 306a-h can also releasably secure the medical instruments 302a-h using a retaining mechanism (not shown).

As shown in <FIG>, the dispenser system <NUM> can also include a receiver <NUM> which can receive the desired medical instrument <NUM> for dispensing, in this example medical instrument 302a. The receiver <NUM> can include a mechanism or a vacuum or air pump (not shown) for obtaining the medical instrument 302a from the particular instrument holder 306a. The receiver <NUM> can also include appropriate sterilization mechanisms (not shown) such as an alcohol spray, etc..

As shown in <FIG>, each instrument holder <NUM> is arranged on the dispenser frame <NUM> around a centre of rotation <NUM> of the dispenser frame <NUM>. The dispenser frame <NUM> can further include a rotating mechanism (not shown) for rotating of the dispenser frame <NUM> around the centre of rotation <NUM>. Thus, for example, rotation of the dispenser frame <NUM> can be effected until the desired medical instrument <NUM> is aligned with the receiver <NUM> for dispensing.

In some example embodiments, each of the medical instruments 302a-h can have a universal body which can each interchangeably be used with the medical insertion device <NUM>. In the example embodiments shown, the medical instruments 302a-h can each have a similar elongate cylindrical body for interfacing with a corresponding shape of the device holder <NUM> (<FIG>). It can be appreciated that the dispenser system <NUM> therefore generally acts as a holster for the medical instruments 302a-h.

Reference is now made to <FIG>, which show a dispenser assembly <NUM> in accordance with another example embodiment. <FIG> shows a lateral mode of dispensing while <FIG> shows an upper mode of dispensing. In the lateral mode (<FIG>) the instrument holders <NUM> are directed laterally (sideways) for accessing of the medical instruments <NUM>. In the upper mode (<FIG>) the instrument holders <NUM> are directed upwardly for accessing of the medical instruments <NUM>. As shown, the dispenser system <NUM> is mounted onto a stand <NUM>. The stand <NUM> includes a plurality of wheels <NUM> (e.g. five), which are lockable once wheeled to the desired position. The stand <NUM> also includes a swivel mechanism <NUM>, which can swivel and lock the dispenser system <NUM> between the lateral mode (<FIG>) and the upper mode (<FIG>).

Reference is now made to <FIG>, which show a robotic surgical system <NUM> including a magnetic resonance imaging (MRI) system <NUM> in accordance with an example embodiment. As shown, a breast imaging assembly <NUM> can be used with a patient support table <NUM>. The patient lies prone on top of the assembly <NUM> with the sternum resting on a central support beam (not shown). The patient's head is supported by head support <NUM>. The patient's shoulders are supported by shoulder supports <NUM>. The patient's breasts extend down into the breast imaging assembly <NUM>. As shown, the patient may be put into the magnet bore hole of the MRI system <NUM> head first. Alternatively, the patient may be inserted feet first into the MRI system <NUM>.

The breasts are compressed by compression plates <NUM>, wherein the compression plates <NUM> may compress the breast either in a head/feet direction or a lateral direction. When compressing, the compression plates <NUM> act as a breast stabilization mechanism. In other example embodiments, the compression plates <NUM> can include a plastic plate with a grid of finely-spaced needle guide holes. In the example embodiment shown in <FIG>, the compression plates <NUM> are oriented along the head/feet direction. The compression plates <NUM> can further include a plastic plate with large rectangular access windows, which is advantageous when used for positioning of the medical instruments <NUM>. In yet further embodiments, a non-compressive stabilization device may be used.

As best shown in <FIG>, the medical insertion device <NUM> can be dimensioned to be positioned in the limited space located between the head support <NUM> and the patient support table <NUM>, typically having a restricted height as shown.

In an alternate embodiment, the compression plates <NUM> are oriented along the lateral direction and the medical insertion device <NUM> is positioned laterally for procedures to be performed outside of the magnet bore hole of the MRI system <NUM>.

The position of the alignment fiducials <NUM> (<FIG>) relative to the tumor is measured or located on the MR images. The appropriate position and/or angle of the medical instrument <NUM> can then be determined, and the medical instrument <NUM> is moved to that position and/or angle using the medical insertion device <NUM>. In another example embodiment, a proper needle entry hole can be determined by determining which hole in the compression plate <NUM> is closest to the desired entry point, as would be understood in the art.

It can be appreciated that the closed geometry RF coils may be used with a plurality of windings, which can interfere with a lateral or medial biopsy approach direction in some existing conventional systems.

Generally, the tip of the biopsy device (or ablative device) may be seen in the image and can be accurately steered towards a suspected lesion location as imaging continues. This will allow adjustments to the trajectory of the biopsy device which are necessary if the lesion location moves for any reason. In the case of ablative therapy, the robotic manipulation system allows the tool to be repositioned as necessary, in-situ, in order to achieve the goals of the intervention. As mentioned, alignment fiducials (not shown) may also be placed onto the medical instrument <NUM> to assist in registration.

Referring to <FIG>, in some example embodiments, the dispenser system <NUM> can be mounted onto a front of the frame of the MRI system <NUM>. In such embodiments, the medical insertion device <NUM> can be swung out or otherwise controlled to access the dispenser system <NUM>. In another example embodiment, also shown in <FIG>, the dispenser assembly <NUM> can be rolled and locked into position adjacent to the front of the MRI system <NUM>. In other example embodiments, the dispenser system <NUM> can be integrated within or attached to the patient support table <NUM> for dispensing of the various medical instruments <NUM>. In such embodiments, the medical insertion device <NUM> may, for example, pitch down into the table <NUM> to obtain or replace the medical instrument <NUM>.

As shown in <FIG>, in some example embodiments, the dispenser system <NUM> can be mounted onto a rear side of the frame of the MRI system <NUM>, for example in the upper mode of dispensing. In another example embodiment, also shown in <FIG>, the dispenser assembly <NUM> can be rolled and locked into position adjacent to the rear side of the MRI system <NUM>.

Reference is now made to <FIG>, which show a robotic surgical system <NUM> including a mammography system <NUM> in accordance with an example embodiment. The mammography system <NUM> can, for example, include an X-Ray based system, an MBI system, or a positron emission mammography (PEM) based system. In PEM/MBI, prior to imaging, an agent is injected into the patient which assists in detection of the lesion. Compression plates 504a, 504b are used to provide stability and immobilization of the breasts. The compression plates 504a, 504b can also include PEM detectors mounted thereon.

As shown in <FIG>, there is a limited space in the region transverse to the patient between the compression plates 504a, 504b. In example embodiments, the medical insertion device <NUM> is dimensioned to fit in this transverse region between the compression plates 504a, 504b. Referring briefly again to <FIG>, a height of the drive support plate <NUM> of the frame <NUM> can be dimensioned to fit within the transverse space between the compression plates 504a, 504b. In another embodiment (not shown), the medical insertion device <NUM> is mounted onto the lower compression plate 504b within this transverse region.

As shown, a robotic arm <NUM> has one end mounted to the mammography system <NUM> and the other end has the medical insertion device <NUM> mounted thereon. The robotic arm <NUM> can, for example, place the medical insertion device <NUM> between the compression plates 504a, 504b at the appropriate time of the procedure. In other embodiments (not shown), the robotic arm <NUM> can place the medical insertion device <NUM> for superior insertion (e.g., from the head) with the compression plates 504a, 504b mounted transversely (for transverse compression) or otherwise suitably modified.

In some example embodiments, as shown in <FIG>, the dispenser system <NUM> can be mounted within the frame of the mammography system <NUM>. In such embodiments, the medical insertion device <NUM> can controlled or maneuvered to access the dispenser system <NUM> using the robotic arm <NUM>. In some example embodiments, the dispenser system <NUM> does not rotate but rather the robotic arm <NUM> is used to retrieve the medical instrument <NUM> from the appropriate instrument holder <NUM>.

As shown in <FIG>, grid marks <NUM> may be shown in the virtual image to guide the medical insertion device <NUM> to the target site.

After the core biopsy is performed, the medical insertion device <NUM> provides an opportunity for other minimally invasive diagnostic procedures and treatments. Examples include: (<NUM>) gamma detectors; (<NUM>) energized tunneling tips to reduce tunneling forces; (<NUM>) inserts to aid in reconstruction of removed tissue (e.g., one or two sided shaver inserts); (<NUM>) spectroscopy imaging devices; (<NUM>) general tissue characterization sensors {e.g., (a) mammography; (b) ultrasound, sonography, contrast agents, power Doppler; (c) PET and FDG ([Flourine-<NUM>]-<NUM>-deoxy-<NUM>-fluoro-glucose); (d) MRI or NMR, breast coil; (e) mechanical impedance or elastic modulus; (f) electrical impedance; (g) optical spectroscopy, raman spectroscopy, phase, polarization, wavelength/frequency, reflectance; (h) laser-induced fluorescence or auto-fluorescence; (i) radiation emission/detection, radioactive seed implantation; (j) flow cytometry; (k) genomics, PCR (polymerase chain reaction)-brcal, brca2; (I) proteomics, protein pathway}; (<NUM>) tissue marker sensing device; (<NUM>) inserts or devices for MRI enhancement; (<NUM>) bishops on-a-stick; (<NUM>) endoscope; (<NUM>) diagnostic pharmaceutical agents delivery devices; (<NUM>) therapeutic anti-cancer pharmaceutical agents delivery devices; (<NUM>) radiation therapy delivery devices, radiation seeds; (<NUM>) anti-seeding agents for therapeutic biopsies to block the release of growth factors and/or cytokines (e.g., chlorpheniramine (CPA) is a protein that has been found to reduce proliferation of seeded cancer cells by <NUM>% in cell cultures. ); (<NUM>) fluorescent tagged antibodies, and a couple fiber optics to stimulate fluorescence from a laser source and to detect fluorescence signals for detecting remaining cancer cells; (<NUM>) positive pressure source to supply fluid to the cavity to aid with ultrasound visualization or to inflate the cavity to under the shape or to reduce bleeding; (s6) biological tagging delivery devices (e.g., (a) functional imaging of cellular proliferation, neovacularity, mitochondrial density, glucose metabolism; (b) immunohistochemistry of estrogen receptor, herzneu; (c) genomics, PCR (polymerase chain reaction)-brca1, brca2; (d) proteomics, protein pathway); (<NUM>) marking clips; (<NUM>) mammotome; and (zg) obturator trocar; (<NUM>) ablative therapies (cryo, RF, laser, etc.).

Reference is now made to <FIG>, which shows a block diagram of a robotic surgical system <NUM> to which example embodiments may be applied. The system <NUM> includes a surgical robot <NUM> for use in a surgical environment. The surgical robot <NUM> is in communication with a control station <NUM> either over a communications network <NUM> (as shown), or via a direct connection. Generally, the surgical robot <NUM> includes one or more robotic instrument(s) <NUM> which can be operational in a limited size operating environment defined by an imaging system such as magnetic resonance imaging (MRI). At least one of the robotic surgical instruments <NUM> may include the medical insertion device <NUM> as shown in <FIG>.

Referring still to <FIG>, the surgical robot <NUM> includes a controller <NUM> for controlling operation of the surgical robot <NUM>, a communications module or subsystem <NUM> for communicating with the control station <NUM> over the network <NUM>, and robotic surgical instruments <NUM> which are controllable by the control station <NUM> over the network <NUM>. In an example embodiment, the robotic surgical instruments may be haptically controllable which can include force-feedback or touch-feedback control. The controller <NUM> can include one or more microprocessors or processors that are coupled to a storage <NUM> (e.g. computer readable storage medium) that includes persistent and/or transient memory. The storage <NUM> stores information and software enabling the microprocessor(s) of controller <NUM> to control the subsystems and implement the functionality described herein. The surgical robot <NUM> includes a detector subsystem <NUM> for determining spatial information relating to a surgical environment of the surgical robot <NUM> (including a subject patient) and sending/relaying said information to the control station <NUM> over the network <NUM>. As shown, in some example embodiments the detector <NUM> may include a camera <NUM> (for capturing video and/or audio information), an x-ray system <NUM>, an ultrasound system <NUM>, an MRI <NUM>, or others such as Positron Emission Tomography (PET), Positron Emission Mammography (PEM), CT laser mammography, or a GE (TM) molecular biological imager. In some example embodiments, the controller <NUM> is configured to operate or provide a local control loop between at least one of the subsystems and the robotic surgical instruments <NUM>.

The control station <NUM> includes a controller <NUM> for controlling operation of the control station <NUM> and a communications subsystem <NUM> for communicating with the surgical robot <NUM> over the network <NUM>. The controller <NUM> is coupled to a storage <NUM>. A control console <NUM> provides an interface for interaction with a user, for example a surgeon. The control console <NUM> includes a display <NUM> (or multiple displays), and a user input <NUM>. In some embodiments, the user input <NUM> may further include haptic controllers (not shown) for allowing the user to haptically control the robotic surgical instruments <NUM> of the surgical robot <NUM>, for example with force-feedback or touch control. Although only one control station <NUM> is shown, in other embodiments two or more control stations may be used, each configured for controlling at least part of the surgical robot <NUM>. An example interface is shown in <FIG>, which in example embodiments includes a graphical user interface (GUI) for interfacing with the user.

Generally, the system <NUM> can be used to perform a procedure by breaking down a procedure into a series of interconnected sub-tasks. Some of the sub-tasks are performed automatically by the surgical robot <NUM> to control the robotic instruments <NUM> and the subsystems to perform the particular sub-task. Some of the other sub-tasks are "semi-automated", meaning having some control from the control station <NUM> as well as some local control from the controller <NUM>.

Each defined sub-task may for example be stored in a storage <NUM> accessible by the controller <NUM>, the storage <NUM> including a library. The library includes a sequence of sub-tasks (both automated and "semi-automated"). Specifically, some of the sub-tasks have instructions to automatically control the robotic instruments <NUM> and the subsystems to perform the sub-task. During automated control, the controller <NUM> may automatically perform the surgical functions by providing the local control loop with the subsystems. Some of the other sub-tasks may be "semi-automated", meaning having some control from the control station <NUM> as well as some local automation (with the controller <NUM> providing local control loops as described herein). During semi-automated control, the control station <NUM> and the subsystems may be in a master-slave relationship. In example embodiments, such semi-automated control may be configured in an external control loop as between the subsystems and the robotic instruments <NUM>, which are facilitated by the control station <NUM>.

The sub-task may be selectively retrieved from the library and combined into a defined sequence or sequences to perform the surgical procedure. The flow from one sub-task to another is stored in the library. Each sub-task may use imagery and other parameters to verify sub-task completion. In some example embodiments, each of the sub-tasks in a particular entire procedure may be automatically performed by the surgical robot <NUM>.

For example, for a breast biopsy a first sub-task may be the semi-automated positioning of the medical insertion tool <NUM> by the surgeon in front of the desired insertion region, while the second sub-task may be the automated insertion of the biopsy needle subcutaneously into the target site.

Referring again to <FIG>, the robotic surgical instruments <NUM> may include any number or combination of controllable mechanisms. The robotic surgical instruments <NUM> include end effectors such as grippers, cutters, manipulators, forceps, bi-polar cutters, ultrasonic grippers & probes, cauterizing tools, suturing devices, etc. The robotic surgical instruments <NUM> generally include small lightweight actuators and components. In some example embodiments, the robotic surgical instruments <NUM> include pneumatic and/or hydraulic actuators. Such actuators may further assist in providing motion stability, as further described below. In some example embodiments, various lightweight radiolucent materials for robotic arms as well as the range joint torques, forces, frequency response, ROM, weight and size of different actuators to achieve the maximum function in the surgical robot <NUM>. In another example embodiment, the robotic surgical instrument <NUM> may be configured to include a therapeutic tool utilizing the administration of high intensity focused ultrasound (HIFU) to control haemorrhage and treat solid tumours. Both the HIFU and the ultrasound <NUM> (for detecting the surgical environment) may be implemented within the same robotic surgical instrument <NUM>.

Referring still to <FIG>, the detector subsystem <NUM> will now be described in greater detail. The incorporation of intra-operative image guidance into surgical robotics provides an additional capability to refine the precision of a surgical procedure. Pre-operative diagnostic imagery may be utilized to plan surgical procedures with the assumption that these diagnostic images will represent tissue morphology at the time of surgery. Along with this pre-operative planning, intra-operative imagery may also be used to modify or refine a present surgical procedure or administer minimally invasive treatment such as HIFU ultrasound therapy used to control bleeding.

One aspect of such image-guided surgery in accordance with example embodiments is registering multiple images to each other and to the patient, tracking instruments intra-operatively and subsequently translating this imagery for real time use in the robot space. The incorporation of medical imagery into surgical planning for the system <NUM> facilitates the identification of a defined work envelope for single or multiple robotic arms. Intra-operative tracking of the position of the robotic surgical instruments <NUM> within the defined work envelope can be utilized to develop local control loop systems between the detector <NUM> and the robotic surgical instruments <NUM> to define keep-out and work within zones for surgical tasks. This data is incorporated into known algorithms developed for collision avoidance of the multiple robotic arms and optimization of the position of instrumentation for completion of the surgical task.

Different technologies that incorporate a physical marker, such as MR, X-Ray, IR (Infrared) markers or RF (Radiofrequency) devices, or chemical markers, may be used for image registration of specific anatomical landmarks for both the intra-operative tracking of the surgical robot <NUM> in relation to the patient as well as tracking the surgical instrumentation. Image-based registration is less sensitive to calibration and tracking errors as it provides a direct transformation between the image space and the instrument space. The information from anatomical landmarks can be registered with the diagnostic imagery used to plan the surgical procedure and subsequently translated into the robotic space for completion of an image guided surgical procedure. This translation is performed using a registration procedure between the robot and the imaging device. The incorporation of real-time intra-operative tracking of anatomical landmarks provides a mechanism of incorporating compensatory motion of the robotic arm to accommodate patient movement thereby enhancing the precision of the robotic task.

In another example embodiment, the detector subsystem <NUM> includes the incorporation of image guidance into the robotic surgery, including predetermined marker shapes and positions that provide optimal accuracy for fiducial marker monitoring and tracking of anatomical landmarks, instrument position and the position of the robotic arms under the constraints imposed by the imaging device and the limited volume available in the surgical work envelope.

Imagery can also be incorporated as one of many parameters used to provide local control loop feedback in performing autonomous robotic tasks. In some example embodiments, the control station <NUM> and the surgical robot <NUM> operate in a master slave relationship. Such embodiments may incorporate semi-autonomous surgical robotics wherein the surgical robot <NUM> may autonomously perform some specified surgical tasks that are part of a sequence of a larger task comprising the surgical procedure, for example using a locally controlled loop implemented by the controller <NUM>. This may for example enables the surgeon to selectively perform techniques best undertaken with a master slave relationship while using automated robotics to perform specific tasks that require the enhanced precision of a surgical robot. For example, such tasks may include the precision placement of brachytherapy for cancer treatment or the precision drilling and intra-operative positioning of hardware in orthopaedic surgery.

In another aspect the control station <NUM> displays diagnostic images, uploaded from a diagnostic workstation (such as CT, MRI, or the like), such that a clinician may select start (insertion point) and end (lesion) location points. A 3D representation of the 2D image slice data with controllable view angle enables the clinician to plan an optimal path avoiding blood vessels and other tissue structures. The avoidance of hematoma can be important with regard to post biopsy image quality for target confirmation.

The control station <NUM> calculates the linear and angular motions necessary to move the surgical robotic manipulator over the planned trajectory and send appropriate commands to plurality of motors to move the medical instrument.

Referring still to <FIG>, the communications network <NUM> may further include a direct wireless connection, a satellite connection, a wide area network such as the Internet, a wireless wide area packet data network, a voice and data network, a public switched telephone network, a wireless local area network (WLAN), or other networks or combinations of the forgoing.

In one aspect the surgical robot <NUM> can move the medical instrument <NUM> while diagnostic images are being acquired. This can reduce the targeting confirmation time can be critical in light of contrast enhancement degradation issues. In addition, targeting errors as a result of lesion motion due to the force of the advancing needle, for example, can also be adjusted with the patient remaining within the magnet bore hole. The automated steering uses targeting software as well as force sensors to prevent accidental excursion into the wrong tissue. The software allows the medical practitioner to plan the full trajectory of the needle or ablation instrument from the skin surface down to the lesion and to steer the medical instrument <NUM> using real time MR. Again, MR fiducials as well as of MR molecular tagging may also be used to improve targeting accuracy.

In yet another aspect a remote control station <NUM> can enable control of the robotic instruments <NUM> from a distance such that an expert in the breast biopsy and ablation procedures will direct the procedure from a distance. The remote control station <NUM> can connect to one or more local workstations such that one physician may perform procedures at a plurality of remote sites (the master controller is at the remote site). Alternatively, the local workstation may control the procedure and a remote station will monitor the procedure for teaching purposes, for example. Examples of various systems which can use local and remote workstations collaboratively are described in the <CIT>.

In some example embodiments, rather than the breast biopsy or ablative procedures described herein, additional procedures can be performed using several imaging modalities such as MRI, CT, PET, PEM, BSGI, X-ray, or sonography, or other modalities where there is an advantage to accurately target a pathology for biopsy or ablation. It would also be appreciated that in some example embodiments other areas of the body can be targeted other than the breast. Such applications include liver, axilla (sentinel node biopsy), lung, kidney, prostate, uterus, and neurological.

Claim 1:
A system comprising:
a mounting arm (<NUM>);
a linear slide assembly (<NUM>) including a first track system (<NUM>) and a second track system (<NUM>);
a first carriage coupling (<NUM>), including a first carriage (<NUM>) pivotally connected to a distal portion of the mounting arm (<NUM>) via a first sway arm (<NUM>) using a ball-and-socket pivot connection, which is defined by a ball (<NUM>) of the mounting arm (<NUM>) and a corresponding socket (<NUM>) of the first sway arm (<NUM>), and a
a second carriage (<NUM>) pivotally connected to the distal portion of the mounting arm (<NUM>), and a first coupling arm (<NUM>) is hingedly connected to the second carriage (<NUM>) and to the first sway arm (<NUM>), the first carriage (<NUM>) and the second carriage (<NUM>) being slideably connected to the first track system (<NUM>); and
a second carriage coupling (<NUM>), including a fourth carriage (<NUM>) pivotally connected to a proximal end of the mounting arm (<NUM>) via a second sway arm (<NUM>) and a third carriage (<NUM>) pivotally connected to a proximal end of the mounting arm (<NUM>) via a second sway arm (<NUM>), using a pivoting connection (<NUM>), wherein the second sway arm (<NUM>) is hingedly connected to a second coupling arm (<NUM>), and the second coupling arm (<NUM>) is hingedly connected to a fourth carriage (<NUM>),
wherein the third carriage (<NUM>) and the fourth carriage (<NUM>) being slideably connected to the second track system (<NUM>); and
a device holder (<NUM>) slidably connected to the mounting arm (<NUM>) for interfacing with a medical instrument (<NUM>, <NUM>); and
a first mechanism which moves an insertion carriage (<NUM>) to which the device holder (<NUM>) is connected along an insertion track (<NUM>) of the mounting arm (<NUM>); and
a rotary drive assembly (<NUM>) driving the linear slide assembly (<NUM>) for slideably driving the first, second, third and fourth carriages (<NUM>, <NUM>, <NUM>, <NUM>) along the first (<NUM>) and second (<NUM>) track systems to effect pitch and yaw motion of the medical instrument (<NUM>) attached to the device holder (<NUM>).