Automated in-bore MR guided robotic diagnostic and therapeutic system

A medical insertion device which may be used with or installed within an imaging system, such as magnetic resonance imaging (MRI). 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 and/or angular degrees of freedom for positioning of the medical instrument prior to an insertion of the medical instrument. The medical insertion device 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.

FIELD

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.

BACKGROUND

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.

SUMMARY

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 co-ordinates 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.

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

DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

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 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, 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.

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 is first made toFIGS. 1A and 1B, which show a medical insertion device100in accordance with an example embodiment. Generally, the medical insertion device100may 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 device100can generally be used to retain, position and effect insertion of a medical instrument102, for example a biopsy device103as shown, or for example a treatment device. The device100can generally provide linear, angular and/or rotational degrees of freedom for positioning of the medical instrument102prior to insertion of the medical instrument102.

As shown inFIG. 1B, the medical insertion device100includes a frame104which acts to house the medical insertion device100. The medical insertion device100further includes a linear slide assembly106mounted or connected to the frame104. The medical insertion device further includes a rotary drive assembly108for generally driving the linear slide assembly106, and a carriage assembly110for moving along the linear slide assembly106. The carriage assembly110also generally supports the medical instrument102for positioning and insertion thereof.

Referring still toFIG. 1B, the frame104will now be described in greater detail. The frame104includes a baseplate112and a drive support plate114connected thereto to at least partially form a housing of the medical insertion device100. Other sidewalls or plates (not shown) may also form part of the frame104. The frame104also includes a drive plate strengthening bracket116for strengthening of the connection between the baseplate112and the drive support plate114. Other strengthening brackets (not shown) may also be used. The baseplate112may also include alignment fiducials113or other alignment markers for correlating the physical world with an imaging system (not shown here). An additional alignment fiducial113aor fiducials may be placed on the elongate mounting arm120(e.g. device holder126), or on the medical instrument102itself (not shown), for correlating or registration purposes. In some example embodiments, the alignment fiducials can include MR molecular tagging. In some example embodiments, the frame104encloses almost an entirety of the medical insertion device100, save for the frame104further including or defining an opening at the front for passage of the medical instrument102there through. In yet further embodiments, the frame104is integrated into or forms part of a same frame (not shown here) of the particular imaging system (not shown here). The frame104can be panel shaped to fit within restricted environments having a limited height.

Referring still toFIG. 1B, the carriage assembly110includes an elongate mounting arm120, wherein the mounting arm120includes an insertion track122which runs along a length of the mounting arm120. An insertion carriage124includes a mechanism such as a pneumatic or piezoelectric motor which can move or step the carriage124along the insertion track122. The insertion carriage124is therefore slideably mounted to the insertion track122. A device holder126is connected to the carriage124. The device holder126is generally tubular shaped and acts as an interface to receive or interface with the medical instrument102. As shown inFIG. 1B, the device holder126includes a sheath to receive a corresponding tubular-shaped main body128of the medical instrument102. Thus, movement of the insertion carriage124along the insertion track122causes the medical instrument102to move in an insertion direction127. In the example shown, the mounting arm120also defines the insertion direction127. In some example embodiments, the mounting arm120and/or the device holder126includes 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 toFIG. 1B, the medical instrument102typically includes the main body128and an elongate member130such as a needle which extends from the main body128. In example embodiments, the elongate member130is formed from MR compatible materials such as carbon fibre, ceramic, or tritanium. One example of the medical instrument102is a biopsy tool103, such as a vacuum assisted biopsy (VAB) device available from ATEC™, as would be understood in the art. The elongate member130can 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 instrument102may 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 instrument102may be integrated with the device holder126to result in a dedicated-purpose insertion device. In yet further example embodiments, the medical instrument102can include an end effector or end effectors.

Reference is now made toFIG. 2, which shows the medical instrument102in a retraction configuration or orientation. As shown, the insertion carriage124is located at a proximal end of the insertion track122, which therefore has retracted the medical instrument102backwards along the insertion direction127(with respect toFIG. 1A). From this position, the insertion carriage124can move along the insertion track122to the distal end of the insertion track122, resulting in the medical instrument102moving in the insertion direction127to an insertion configuration or orientation as shown inFIG. 1A.

In example embodiments, referring again toFIG. 1B, the carriage assembly110generally includes one or more carriages which including pivot connections and/or slideable connections for effecting positioning of the mounting arm120, and therefore positioning of the medical instrument102. Once at the desired position, the next step is typically an insertion step through the skin which includes movement of the insertion carriage124along the insertion track122in the insertion direction127.

In the example shown inFIG. 1B, the carriage assembly110includes a first carriage coupling131and a second carriage coupling132. The first carriage coupling131includes a first carriage134and a second carriage136. The second carriage coupling132includes a third carriage138and a fourth carriage140. As shown, the first carriage134via first sway arm135is connected to a distal end of the mounting arm120using a ball-and-socket pivot connection, which is defined by a ball142of the mounting arm120and a corresponding socket144of the first sway arm135. Such a pivot connection therefore permits pitch or yaw of the mounting arm120in operation. The first carriage134also itself includes a pivoting (e.g. hinged) connection148with the first sway arm135at the linear slide assembly106. The first sway arm135is also hingedly connected to a first coupling arm146. The first coupling arm146is hingedly connected to the second carriage136.

The third carriage138is connected to a proximal end of the mounting arm120via a second sway arm139, using a pivoting connection150such as a first hinge coupled with a second hinge, as shown. The second sway arm139is hingedly connected to a second coupling arm152. The second coupling arm152is hingedly connected to the fourth carriage140. The third carriage138also includes a pivoting (e.g. hinged) connection154to the second sway arm139at the linear slide assembly106.

Referring still toFIG. 1B, the linear slide assembly106provides a support for the carriage assembly110, and includes a first track system160and a second track system162having mechanisms for individually or collectively controlling of the positioning of the carriages134,136,138,140. As shown, the first track system160supports the first carriage coupling131and the second track system162supports the second carriage coupling132. The first and second track systems160,162include straightly moveable or slideable connections with the respective carriages134,136,138,140for facilitating linear translation of the carriages134,136,138,140.

Referring to the first track system160, this includes four rails164a-d, which correspond respectively to channels166a-ddefined by the first carriage134and channels168a-ddefined by the second carriage136, as shown inFIG. 1B. In the example embodiment shown, first and fourth rails164aand164dare smooth rails which act as guide rails for sliding of the first carriage134and the second carriage136. Thus, channels166a,166d,168a, and168dmay also have smooth inner surfaces. Second rail164bincludes a lengthwise screw thread definition which engages corresponding anti-backlash nut (not shown) within channel166bof the first carriage134. Channel168bof second carriage136has a smooth inner surface. Thus, rotation of second rail164bresults in horizontal translation of first carriage134while not affecting the second carriage136. Similarly, third rail164cincludes a lengthwise screw thread definition which engages corresponding anti-backlash nut (not shown) within channel168cof the second carriage136. Channel166cof first carriage134has a smooth inner surface. Thus, rotation of the third rail164cresults in horizontal translation of the second carriage136along the first rail system160while not affecting the first carriage134.

In example embodiments, a similar configuration may be used for the second track system162, which includes four rails170a-d, which correspond respectively to channels172a-ddefined by the third carriage138and channels174a-ddefined by the fourth carriage176, as shown inFIG. 1B. In the example embodiment shown, first and fourth rails170aand170dare smooth rails which act as guide rails for sliding of the third carriage138and the second carriage140. Thus, channels172a,172d,174a, and174dmay also have smooth inner surfaces. Second rail170includes a lengthwise screw thread definition which engages corresponding screw threads of channel172bof the third carriage138. Channel174bof fourth carriage140has a smooth inner surface. Thus, rotation of second rail170bresults in horizontal translation of third carriage138while not affecting the fourth carriage140. Similarly, third rail170cincludes a lengthwise screw thread definition which engages corresponding screw threads of channel174cof the fourth carriage140. Channel172cof third carriage138has a smooth inner surface. Thus, rotation of the third rail170cresults in horizontal translation of the fourth carriage140along the second rail system162while not affecting the third carriage138.

Referring still toFIG. 1B, reference is now made to the rotary drive assembly108, which acts to drive the various tracks of the linear slide assembly106, for driving of the various carriages134,136,138,140of the carriage assembly110. In the example embodiment shown, the rotary drive assembly108includes four rotary drive units180a-d(each or individually referred to as180) each corresponding to a respective rotary drive belt182a-d. As shown, rotary drive unit180ais coupled to rail164b, rotary drive unit180bis coupled to rail164c, rotary drive unit180cis coupled to rail170b, and rotary drive unit180dis coupled to rail170c.

Reference is now made toFIGS. 3A and 3B, which show a rotary drive unit180in greater detail, in accordance with an example embodiment. As shown inFIG. 3B, the drive unit180includes, in sequential adjoining order, a pulley200for engaging the drive belt182a-d, a retaining ring202, a ceramic bearing204, a front motor plate206, a ceramic ring208, a drive shaft210, a second ceramic ring212, a second ceramic bearing214, one or more spacer plates216(two shown), a back motor plate218, and a controller such as a microcontroller or encoder220. Four motors such as ultrasonic motors222can be used to drive the drive shaft210, which are controllable by the encoder220. An example suitable ultrasonic motor222is 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 toFIG. 1B, various modes of operation of the medical insertion device100can be effected to position the medical instrument102by slideably moving at least one of the carriages134,136,138,140. For example, for each carriage coupling131,132the individual carriages may be moved so that relative motion (left or right) between two carriages will raise one end of the mounting arm120up or down, either linearly or in a slightly curved trajectory. The slightly curved trajectory also results in axial rotation of the medical instrument102. Translation of the two carriages couplings131,132in unison results in a linear translation left and right. A differential motion left and right between the first carriage coupling131and the second carriage coupling132results in a horizontal angular motion (yaw), while a differential vertical motion between the first carriage coupling131and the second carriage coupling132results in a vertical angle (pitch). Raising or lowering the first carriage coupling131and the second carriage coupling132in unison results in a combined vertical motion.

Reference is thus made toFIGS. 4A and 4B, which show the medical insertion device100in a pitch up configuration. As shown, to effect the pitch up configuration, the first carriage134and the second carriage136are slideably moved relatively towards each other. In some embodiments, only one of the first carriage134and the second carriage136is moved towards the other, resulting in a slightly curved pitch up trajectory. This slightly curved trajectory also results in axial rotation of the medical instrument102. In another example embodiment (not shown), a pitch down may be effected by having the first carriage134and the second carriage136slideably moved relatively away from each other.

Reference is also made toFIGS. 5A and 5B, which show the medical insertion device100in a straight insertion configuration. As shown, to effect the straight insertion configuration, at least one of the carriages134,136,138,140are slideably moved to cause the medical instrument102to be horizontally oriented, which would be rectilinear to the insertion target.

Reference is now made toFIGS. 6A and 6B, which show the medical insertion device100in a translated configuration. As shown, all of the carriages134,136,138,140are slideably moved at the same displacement in a direction, for example left (as shown) or right.

Reference is now made toFIGS. 7A,7B and7C, which show the medical insertion device100in a yaw configuration. As best shown inFIG. 7C, the carriages138,140of the second carriage coupling132can be collectively moved leftwardly relative to the first carriage coupling131to result in the medical instrument102being angled in a yaw right direction. Similarly, the carriages138,140of the second carriage coupling132can be collectively moved rightwardly relative to the first carriage coupling131to result in the medical instrument102being angled in a yaw left direction (not shown).

Referring again toFIG. 1B, it can be appreciated that the medical insertion device100can effect various insertion angles of the medical instrument102which 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 device100may provide a stable insertion angle for the subsequent insertion step. In addition, the medical instrument102may for example be able to reach additional target regions such as those near the edges of the frame104(e.g. at regions beyond the linear slide assembly106closer to the baseplate112).

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 toFIG. 1B, in another mode of operation, it can be appreciated that the device holder126can be reversed, in that the body128of the medical instrument102can be inserted into the other opening184of the device holder126. For example, the configuration shown inFIG. 1Bmay be used for superior (from the head) insertion at the right breast in a “right side” configuration. The entire medical instrument102(e.g. the frame104) can then be reversed with the body128of the medical instrument102inserted into the other opening184of the device holder126for 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 device100in a limited space environment such as within an MRI (not shown here).

Suitable materials for the various described assemblies and subsystems of the device100include 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 device100in example embodiments. For example, in some example embodiment, an insertion mechanism may be used to move the entire linear slide assembly106in the insertion direction127to provide the insertion step (rather than from the insertion track122). In some additional embodiments, some medical instruments102may 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 instrument102such as the elongate member130(e.g. a needle) is independently controllable by a mechanism for insertion.

Reference is now made toFIGS. 8A and 8B, which shows a dispenser system300in accordance with an example embodiment. The dispenser system300can for example be used with an imaging system (not shown here) to dispense one or more medical instruments302a-h(each or individually referred to as302) to the medical insertion device100(FIG. 1A). As shown, the dispenser system300includes a dispenser frame304which can be adjoined or attached to the particular imaging system. The dispenser frame304includes or defines a plurality of instrument holders306a-h(each or individually referred to as306) for respectively holding the medical instruments302a-h. The instrument holders306a-hcan also releasably secure the medical instruments302a-husing a retaining mechanism (not shown).

As shown inFIG. 8A, the dispenser system300can also include a receiver308which can receive the desired medical instrument302for dispensing, in this example medical instrument302a. The receiver308can include a mechanism or a vacuum or air pump (not shown) for obtaining the medical instrument302afrom the particular instrument holder306a. The receiver308can also include appropriate sterilization mechanisms (not shown) such as an alcohol spray, etc.

As shown inFIG. 8A, each instrument holder306is arranged on the dispenser frame304around a centre of rotation310of the dispenser frame304. The dispenser frame304can further include a rotating mechanism (not shown) for rotating of the dispenser frame304around the centre of rotation310. Thus, for example, rotation of the dispenser frame304can be effected until the desired medical instrument302is aligned with the receiver308for dispensing.

In some example embodiments, each of the medical instruments302a-hcan have a universal body which can each interchangeably be used with the medical insertion device100. In the example embodiments shown, the medical instruments302a-hcan each have a similar elongate cylindrical body for interfacing with a corresponding shape of the device holder126(FIG. 1A). It can be appreciated that the dispenser system300therefore generally acts as a holster for the medical instruments302a-h.

Reference is now made toFIGS. 8C and 8D, which show a dispenser assembly320in accordance with another example embodiment.FIG. 8Cshows a lateral mode of dispensing whileFIG. 8Dshows an upper mode of dispensing. In the lateral mode (FIG. 8C) the instrument holders306are directed laterally (sideways) for accessing of the medical instruments302. In the upper mode (FIG. 8D) the instrument holders306are directed upwardly for accessing of the medical instruments302. As shown, the dispenser system300is mounted onto a stand322. The stand322includes a plurality of wheels324(e.g. five), which are lockable once wheeled to the desired position. The stand322also includes a swivel mechanism324, which can swivel and lock the dispenser system300between the lateral mode (FIG. 8C) and the upper mode (FIG. 8D).

Reference is now made toFIGS. 9A to 9C, which show a robotic surgical system400including a magnetic resonance imaging (MRI) system402in accordance with an example embodiment. As shown, a breast imaging assembly404can be used with a patient support table406. The patient lies prone on top of the assembly404with the sternum resting on a central support beam (not shown). The patient's head is supported by head support408. The patient's shoulders are supported by shoulder supports410. The patient's breasts extend down into the breast imaging assembly404. As shown, the patient may be put into the magnet bore hole of the MRI system402head first. Alternatively, the patient may be inserted feet first into the MRI system402.

The breasts are compressed by compression plates412, wherein the compression plates412may compress the breast either in a head/feet direction or a lateral direction. When compressing, the compression plates412act as a breast stabilization mechanism. In other example embodiments, the compression plates412can include a plastic plate with a grid of finely-spaced needle guide holes. In the example embodiment shown inFIG. 9A, the compression plates412are oriented along the head/feet direction. The compression plates412can further include a plastic plate with large rectangular access windows, which is advantageous when used for positioning of the medical instruments302. In yet further embodiments, a non-compressive stabilization device may be used.

As best shown inFIG. 9C, the medical insertion device100can be dimensioned to be positioned in the limited space located between the head support408and the patient support table406, typically having a restricted height as shown.

In an alternate embodiment, the compression plates412are oriented along the lateral direction and the medical insertion device100is positioned laterally for procedures to be performed outside of the magnet bore hole of the MRI system402.

The position of the alignment fiducials113(FIG. 1B) relative to the tumor is measured or located on the MR images. The appropriate position and/or angle of the medical instrument102can then be determined, and the medical instrument102is moved to that position and/or angle using the medical insertion device100. In another example embodiment, a proper needle entry hole can be determined by determining which hole in the compression plate412is 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 instrument102to assist in registration.

Referring toFIG. 9A, in some example embodiments, the dispenser system300can be mounted onto a front of the frame of the MRI system402. In such embodiments, the medical insertion device100can be swung out or otherwise controlled to access the dispenser system300. In another example embodiment, also shown inFIG. 9A, the dispenser assembly320can be rolled and locked into position adjacent to the front of the MRI system402. In other example embodiments, the dispenser system300can be integrated within or attached to the patient support table406for dispensing of the various medical instruments302. In such embodiments, the medical insertion device100may, for example, pitch down into the table406to obtain or replace the medical instrument102.

As shown inFIG. 9B, in some example embodiments, the dispenser system300can be mounted onto a rear side of the frame of the MRI system402, for example in the upper mode of dispensing. In another example embodiment, also shown inFIG. 9B, the dispenser assembly320can be rolled and locked into position adjacent to the rear side of the MRI system402.

Reference is now made toFIGS. 10A to 10C, which show a robotic surgical system500including a mammography system502in accordance with an example embodiment. The mammography system502can, 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 plates504a,504bare used to provide stability and immobilization of the breasts. The compression plates504a,504bcan also include PEM detectors mounted thereon.

As shown inFIG. 10C, there is a limited space in the region transverse to the patient between the compression plates504a,504b. In example embodiments, the medical insertion device100is dimensioned to fit in this transverse region between the compression plates504a,504b. Referring briefly again toFIG. 1A, a height of the drive support plate114of the frame104can be dimensioned to fit within the transverse space between the compression plates504a,504b. In another embodiment (not shown), the medical insertion device100is mounted onto the lower compression plate504bwithin this transverse region.

As shown, a robotic arm506has one end mounted to the mammography system502and the other end has the medical insertion device100mounted thereon. The robotic arm506can, for example, place the medical insertion device100between the compression plates504a,504bat the appropriate time of the procedure. In other embodiments (not shown), the robotic arm506can place the medical insertion device100for superior insertion (e.g., from the head) with the compression plates504a,504bmounted transversely (for transverse compression) or otherwise suitably modified.

In some example embodiments, as shown inFIG. 10B, the dispenser system300can be mounted within the frame of the mammography system502. In such embodiments, the medical insertion device100can controlled or maneuvered to access the dispenser system300using the robotic arm506. In some example embodiments, the dispenser system300does not rotate but rather the robotic arm506is used to retrieve the medical instrument302from the appropriate instrument holder306.

As shown inFIG. 10C, grid marks510may be shown in the virtual image to guide the medical insertion device100to the target site.

After the core biopsy is performed, the medical insertion device100provides an opportunity for other minimally invasive diagnostic procedures and treatments. Examples include: (1) gamma detectors; (2) energized tunneling tips to reduce tunneling forces; (3) inserts to aid in reconstruction of removed tissue (e.g., one or two sided shaver inserts); (4) spectroscopy imaging devices; (5) general tissue characterization sensors {e.g., (a) mammography; (b) ultrasound, sonography, contrast agents, power Doppler; (c) PET and FDG ([Flourine-18]-2-deoxy-2-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)-brca1, brca2; (l) proteomics, protein pathway}; (6) tissue marker sensing device; (7) inserts or devices for MRI enhancement; (8) bishops on-a-stick; (9) endoscope; (10) diagnostic pharmaceutical agents delivery devices; (11) therapeutic anti-cancer pharmaceutical agents delivery devices; (12) radiation therapy delivery devices, radiation seeds; (13) 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 sells by 75% in cell cultures.); (14) 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; (15) 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; (16) biological tagging delivery devices (e.g., (a) functional imaging of cellular proliferation, neovacularity, mitochondrial density, glucose metabolism; (b) immunohistochemistry of estrogen receptor, her2neu; (c) genomics, PCR (polymerase chain reaction)-brca1, brca2; (d) proteomics, protein pathway); (17) marking clips; (18) mammotome; and (19) obturator trocar; (20) ablative therapies (cryo, RF, laser, etc.).

Reference is now made toFIG. 11, which shows a block diagram of a robotic surgical system10to which example embodiments may be applied. The system10includes a surgical robot12for use in a surgical environment. The surgical robot12is in communication with a control station16either over a communications network18(as shown), or via a direct connection. Generally, the surgical robot12includes one or more robotic instrument(s)24which 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 instruments24may include the medical insertion device100as shown inFIG. 1A.

Referring still toFIG. 11, the surgical robot12includes a controller20for controlling operation of the surgical robot12, a communications module or subsystem22for communicating with the control station16over the network18, and robotic surgical instruments24which are controllable by the control station16over the network18. In an example embodiment, the robotic surgical instruments may be haptically controllable which can include force-feedback or touch-feedback control. The controller20can include one or more microprocessors or processors that are coupled to a storage21(e.g. computer readable storage medium) that includes persistent and/or transient memory. The storage21stores information and software enabling the microprocessor(s) of controller20to control the subsystems and implement the functionality described herein. The surgical robot12includes a detector subsystem28for determining spatial information relating to a surgical environment of the surgical robot12(including a subject patient) and sending/relaying said information to the control station16over the network18. As shown, in some example embodiments the detector28may include a camera30(for capturing video and/or audio information), an x-ray system32, an ultrasound system34, an MRI36, or others such as Positron Emission Tomography (PET), Positron Emission Mammography (PEM), CT laser mammography, or a GE™ molecular biological imager. In some example embodiments, the controller20is configured to operate or provide a local control loop between at least one of the subsystems and the robotic surgical instruments24.

The control station16includes a controller40for controlling operation of the control station16and a communications subsystem42for communicating with the surgical robot12over the network18. The controller40is coupled to a storage41. A control console44provides an interface for interaction with a user, for example a surgeon. The control console44includes a display46(or multiple displays), and a user input48. In some embodiments, the user input48may further include haptic controllers (not shown) for allowing the user to haptically control the robotic surgical instruments24of the surgical robot12, for example with force-feedback or touch control. Although only one control station16is shown, in other embodiments two or more control stations may be used, each configured for controlling at least part of the surgical robot12. An example interface is shown inFIG. 12, which in example embodiments includes a graphical user interface (GUI) for interfacing with the user.

Generally, the system10can 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 robot12to control the robotic instruments24and the subsystems to perform the particular sub-task. Some of the other sub-tasks are “semi-automated”, meaning having some control from the control station16as well as some local control from the controller20.

Each defined sub-task may for example be stored in a storage21accessible by the controller20, the storage21including 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 instruments24and the subsystems to perform the sub-task. During automated control, the controller20may 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 station16as well as some local automation (with the controller20providing local control loops as described herein). During semi-automated control, the control station16and 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 instruments24, which are facilitated by the control station16.

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 robot12.

For example, for a breast biopsy a first sub-task may be the semi-automated positioning of the medical insertion tool100by 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 toFIG. 11, the robotic surgical instruments24may include any number or combination of controllable mechanisms. The robotic surgical instruments24include end effectors such as grippers, cutters, manipulators, forceps, bi-polar cutters, ultrasonic grippers & probes, cauterizing tools, suturing devices, etc. The robotic surgical instruments24generally include small lightweight actuators and components. In some example embodiments, the robotic surgical instruments24include 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 robot12. In another example embodiment, the robotic surgical instrument24may 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 ultrasound34(for detecting the surgical environment) may be implemented within the same robotic surgical instrument24.

Referring still toFIG. 11, the detector subsystem28will 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 system10facilitates the identification of a defined work envelope for single or multiple robotic arms. Intra-operative tracking of the position of the robotic surgical instruments24within the defined work envelope can be utilized to develop local control loop systems between the detector28and the robotic surgical instruments24to 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 robot12in 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 subsystem28includes 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 station16and the surgical robot12operate in a master slave relationship. Such embodiments may incorporate semi-autonomous surgical robotics wherein the surgical robot12may 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 controller20. 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 station16displays 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 station16calculates 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 toFIG. 11, the communications network18may 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 robot12can move the medical instrument100while 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 we 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 instrument100using 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 station16can enable control of the robotic instruments24from a distance such that an expert in the breast biopsy and ablation procedures will direct the procedure from a distance. The remote control station16can 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 PCT Patent Application No. WO 2007/121,572, the contents of which are herein incorporated by reference.

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.

The various example embodiments described as systems would similarly apply to methods, and vice-versa.

Variations may be made to some example embodiments, which may include combinations and sub-combinations of any of the above. The various embodiments presented above are merely examples and are in no way meant to limit the scope of this disclosure. Variations of the innovations described herein will be apparent to persons of ordinary skill in the art, such variations being within the intended scope of the present disclosure. In particular, features from one or more of the above-described embodiments may be selected to create alternative embodiments comprised of a sub-combination of features which may not be explicitly described above. In addition, features from one or more of the above-described embodiments may be selected and combined to create alternative embodiments comprised of a combination of features which may not be explicitly described above. Features suitable for such combinations and sub-combinations would be readily apparent to persons skilled in the art upon review of the described embodiments. The subject matter described herein intends to cover and embrace all suitable changes in technology.