US20220039876A1

US20220039876A1 - Sensored surgical tool and surgical intraoperative tracking and imaging system incorporating same

Info

Publication number: US20220039876A1
Application number: US17/450,741
Authority: US
Inventors: Yanhui BAI; Michael Frank Gunter WOOD; Cameron Anthony Piron
Original assignee: Synaptive Medical Inc
Current assignee: Synaptive Medical Inc
Priority date: 2017-02-15
Filing date: 2021-10-13
Publication date: 2022-02-10
Also published as: CA2957977A1; CA3028792C; CA2957977C; CA3028792A1; US11172993B2; US20180228553A1

Abstract

A sensored surgical tool, surgical intraoperative tracking and imaging system incorporating same, and methods, involving a rigid elongate tool body having a substantially rigid tool tip to be displaced and tracked within the surgical cavity so to reproducibly locate the tool tip within the cavity. The tool has one or more tool tip cameras and/or pressure sensors operatively disposed along the body at or proximal to the tool tip.

Description

CROSS REFERENCE TO RELATED APPLICATION(S)

This document is a continuation application, claiming the benefit of, and priority to, the following documents: U.S. patent application Ser. No. 15/896,516, entitled “SENSORED SURGICAL TOOL AND SURGICAL INTRAOPERATIVE TRACKING AND IMAGING SYSTEM INCORPORATING SAME,” filed on Feb. 14, 2018, and Canadian Patent Application No. 2,957,977, entitled “SENSORED SURGICAL TOOL AND SURGICAL INTRAOPERATIVE TRACKING AND IMAGING SYSTEM INCORPORATING SAME,” and filed Feb. 15, 2017, all of which are hereby incorporated by reference herein in their entirety.

FIELD

The present disclosure relates to surgical instruments, tools and systems, and, in particular, to a sensored surgical tool for use, for example, within a surgical cavity, such as an open port-based or visually accessible surgical cavity, and a surgical system incorporating such tool, such as a surgical intraoperative tracking and imaging system.

BACKGROUND

In the related art, various surgical site imaging techniques and tools have been developed to improve the accuracy and ultimate success of a given surgical procedure. Related art imaging tools for visually closed-access surgical procedures, for example, are those channeled through an anatomical lumen, e.g., vascular, intestinal procedures, may include fiber optic scopes, optical coherence tomography (OCT) probes, micro ultrasound transducers, and the like, wherein a generally flexible tool is inserted and channeled to a surgical site of interest.
Visually open-access surgical sites, for example, employing a surgical access port or the like, generally rely on related art external imaging devices, such as an overhead down-cavity surgical microscope or an external videoscope and display system. Accordingly, surgical site imaging is generally limited to the different fields of view and view angles available to the external scope and/or surgical microscope, which not only generally limits visibility to down-port images but is also subject to visibility issues when blood or other fluids immerse the surgical cavity or port bottom. Given the limited working space within the port/cavity, and particularly for neurosurgical applications, the highly critical nature of any down-port maneuvers and/or tissue interactions, limited visibility can result in significant surgical challenges, particularly, for example, when seeking to blindly locate and address a bleeding site or evaluate externally visually inaccessible areas within the cavity, such as areas blocked by visually interfering tissue.
Currently, a surgeon will generally seek to reduce the volume of visually interfering fluids using a related art suction tool in an attempt to identify and address a bleeding/leaking site, for example, before the cavity/port is re-immersed with fluid. As for gaining visibility around or below visually interfering tissue, the surgeon may rather seek to re-angle the external scope or microscope, albeit within field of view, and view angle limits prescribed by the external equipment and surgical cavity/port. Accordingly, significant challenges remain in the related art for adequately visualizing, characterizing, and addressing visually inaccessible, obscured, or obstructed portions of the surgical cavity.
Therefore, a need exists for technologies addressing the foregoing challenges experienced in the related art.

SUMMARY

In addressing at least some of the foregoing challenges experienced in the related art, the subject matter of the present disclosure involves a sensored surgical tool, an intraoperative tracking and imaging system, and their methods.
In accordance with an embodiment of the present disclosure, a surgical tool, operable with an external data processing unit, for use within an open surgical cavity, comprises: a rigid elongate tool body comprising a substantially rigid tool tip configured to be displaced and tracked within the open surgical cavity for reproducibly locating the substantially rigid tool tip within the open surgical cavity, the rigid elongate tool body configured to operate with at least one pressure sensor, at least one camera, and the external data processing unit; and a suction tool comprising a suction tool tip portion, the suction tool configured to operate with at least one other pressure sensor, at least one other camera, and the external data processing unit, wherein imaging, locating, and mapping inner cavity characteristics are considered by the external data processing unit in real-time during a surgical procedure, the external data processing unit operable to: associate at least one pressure reading, corresponding to at least one sensor signal from the at least one pressure sensor, with at least one location of each at least one pressure sensor within the open surgical cavity; associate at least one pressure reading, corresponding to at least one sensor signal from the at least one other pressure sensor, with at least one location of each at least one other pressure sensor within the open surgical cavity; and associate at least one respective inner-cavity image with at least one location of the substantially rigid tool tip and at least one location of the suction tool tip portion.
In accordance with an embodiment of the present disclosure, a method of providing a surgical tool, operable with an external data processing unit, for use within an open surgical cavity, comprises: providing a rigid elongate tool body comprising a substantially rigid tool tip configured to be displaced and tracked within the open surgical cavity for reproducibly locating the substantially rigid tool tip within the open surgical cavity, the rigid elongate tool body configured to operate with at least one pressure sensor, at least one camera, and the external data processing unit; and providing a suction tool comprising a suction tool tip portion, the suction tool configured to operate with at least one other pressure sensor, at least one other camera, and the external data processing unit, wherein imaging, locating, and mapping inner cavity characteristics are considered by the external data processing unit in real-time during a surgical procedure, the external data processing unit operable to: associate at least one pressure reading, corresponding to at least one sensor signal from the at least one pressure sensor, with at least one location of each at least one pressure sensor within the open surgical cavity; associate at least one pressure reading, corresponding to at least one sensor signal from the at least one other pressure sensor, with at least one location of each at least one other pressure sensor within the open surgical cavity; and associate at least one respective inner-cavity image with at least one location of the substantially rigid tool tip and at least one location of the suction tool tip portion.
In accordance with an embodiment of the present disclosure, a method of imaging, locating, and mapping inner cavity characteristics within an open surgical cavity by way of a surgical tool, operable with an external data processing unit, comprises: providing the surgical tool, providing the surgical tool comprising: providing a rigid elongate tool body comprising a substantially rigid tool tip configured to be displaced and tracked within the open surgical cavity for reproducibly locating the substantially rigid tool tip within the open surgical cavity, the rigid elongate tool body configured to operate with at least one pressure sensor, at least one camera, and the external data processing unit; and providing a suction tool comprising a suction tool tip portion, the suction tool configured to operate with at least one other pressure sensor, at least one other camera, and the external data processing unit; and considering imaging, locating, and mapping inner cavity characteristics in real-time during a surgical procedure by the external data processing unit, considering comprising: associating at least one pressure reading, corresponding to at least one sensor signal from the at least one pressure sensor, with at least one location of each at least one pressure sensor within the open surgical cavity; associating at least one pressure reading, corresponding to at least one sensor signal from the at least one other pressure sensor, with at least one location of each at least one other pressure sensor within the open surgical cavity; and associating at least one respective inner-cavity image with at least one location of the substantially rigid tool tip and at least one location of the suction tool tip portion.
Other aspects, features and/or advantages will become more apparent upon reading the following non-restrictive description of specific embodiments thereof, given by way of example only with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWING(S)

Several embodiments of the present disclosure are provided, by way of examples only, with reference to the appended drawings, wherein:

FIG. 1 is a diagram illustrating a perspective view of a navigation system, such as a medical navigation system, comprising a patient reference device, in an environmental context, such as an operation room;

FIG. 2 is a schematic diagram illustrating a navigation system, such as a medical navigation system, comprising a patient reference device;

FIG. 3 is a schematic diagram illustrating a sensored surgical tool and associated control and processing unit;

FIG. 4A is a schematic diagram illustrating a cross-sectional view of a disposable tool tip portion of the sensored surgical tool, as shown in FIG. 3;

FIG. 4B is a schematic illustrating a top plan view of the disposable tool tip portion, as shown in FIG. 4A;

FIG. 5 is a diagram illustrating an access port-based surgical procedure being conducted by way of a navigation system;

FIG. 6A is a diagram illustrating a perspective view of a trackable pointing tool having distinctly configured tracking markers;

FIG. 6B is a diagram illustrating a perspective view of a trackable pointing tool having distinctly configured tracking markers;

FIG. 6C is a diagram illustrating a perspective view of a trackable pointing tool having distinctly configured tracking markers;

FIG. 6D is a diagram illustrating a perspective view of a trackable pointing tool having distinctly configured tracking markers;

FIG. 6E is a diagram illustrating a perspective view of a trackable surgical access port having a set of tracking markers;

FIG. 6F is a diagram illustrating a front elevation view of a trackable surgical access port having a set of tracking markers;

FIG. 6G is a diagram illustrating a side view of a trackable surgical access port having a set of tracking markers;

FIG. 6H is a diagram illustrating a top plan view of a trackable surgical access port having a set of tracking markers;

FIG. 7 is a diagram illustrating a perspective view of the pointing tool, as shown in FIG. 6C, engaged with a trackable access port;

FIG. 8 is a schematic diagram illustrating a relationship among components of an overall surgical navigation system;

FIG. 9 is a schematic diagram illustrating a preoperative surgical planning system for use with a medical navigation system;

FIG. 10 is a schematic diagram illustrating an intraoperative surgical management system for use with a medical navigation system;

FIG. 11 is a flow diagram illustrating a method of providing a surgical tool, operable with an external data processing unit, for use within an open surgical cavity; and

FIG. 12 is a flow diagram illustrating a method of imaging, locating, and mapping inner cavity characteristics within an open surgical cavity by way of a surgical tool operable with an external data processing unit.

Elements in the several figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the figures may be emphasized relative to other elements for facilitating understanding of the various presently disclosed embodiments. Also, common, but well-understood elements that are useful or necessary in commercially feasible embodiment are often not depicted in order to facilitate a less obstructed view of these various embodiments of the present disclosure.

DETAILED DESCRIPTION

The embodiments described herein provide different examples of a sensored to surgical tool, and system incorporating same. The tools, systems and methods described herein may be useful in the field neurosurgery, including oncological care, neurodegenerative disease, stroke, brain trauma, and orthopedic surgery. However, the subject matter of the present disclosure may extend or apply to other conditions or fields of medicine, and such extensions or applications are encompassed by the present disclosure. For example, the tools, systems and methods described herein encompass surgical processes that are applicable to surgical procedures for brain, spine, knee, and any other region of the body that will benefit from the use of an access port or small open orifice to define and access a surgical cavity within the interior of an animal body, such as a human body.
Various tools, systems, apparatuses, devices, or processes are below-described and provide examples of sensored surgical tools, and systems incorporating same, in accordance with embodiments of the present disclosure. None of the below-described embodiments limits any claimed embodiment; and any claimed embodiment may also encompass tools, systems, apparatuses, devices, or processes that may differ from the below-described examples. The embodiments of the present disclosure are not limited to tools, systems, apparatuses, devices, or processes having all of the features of any one of the below-described tools, systems, apparatuses, devices, or processes or to features common to some or all of the below-described tools, systems, apparatus, devices, or processes.
Furthermore, this Detailed Description sets forth numerous specific details in order to provide a thorough understanding of the various embodiments described throughout the present disclosure. However, embodiments described herein may be practiced without these specific details. In other instances, well-known methods, procedures and components have not been described in detail so as not to obscure the embodiments described herein.
For instance, in accordance with some aspects of the present disclosure, a sensored surgical tool is described for use in a surgical cavity to provide increased intraoperative inner-cavity visibility and characterization to supplement external imaging device capabilities, for example, to access, image and/or characterize obscured, obstructed or otherwise externally visually inaccessible regions of the surgical cavity. In some aspects, such enhanced inner-cavity characterization may improve intraoperative imaging of the cavity while also assisting in locating and addressing inner-cavity bleeding or other fluid immersions, for example, by location-tracking and mapping imaging and characterization capabilities of the herein-described tools and systems.
In accordance with one aspect, there is provided a surgical tool for use within a surgical cavity, the surgical tool comprising: a rigid elongate tool body having a substantially rigid tool tip to be displaced and tracked within the surgical cavity so to reproducibly locate said tool tip within the cavity; and a pressure sensor operatively disposed along said body at or proximal to said tool tip and responsive to pressure variations applied thereto from within the surgical cavity to output a sensor signal representative thereof as the tool is displaced within the cavity, wherein said sensor signal is externally communicable to associate respective inner-cavity pressure readings with tracked tool tip locations.
In accordance with some embodiments of the present disclosure embodiment, at least one of: the pressure sensor is laterally oriented relative to said tip, the surgical tool further comprises two or more said pressure sensor at or proximate said tool tip, the surgical tool further comprises a set of fiducial markers externally coupled in a fixed configuration to an externally extending portion of said elongate body, wherein said markers are trackable by an external tracking system to automatically determine said tracked tool tip locations with reference to the cavity based on a respective tracked position of said markers, the surgical tool further comprises a radio frequency transmitter to wirelessly communicate said sensor signal, the pressure sensor comprises two or more pressure sensors collocated at or toward said tool tip, the surgical tool further comprises a suction tool at or proximal to said tip to concurrently provide suction within the surgical cavity around said tip, and the surgical cavity is externally visible to an external camera aligned therewith, and wherein said tip is operable as a trackable pointer within the cavity.
In accordance with some embodiments of the present disclosure embodiment, at least one of: the surgical tool further comprises at least one camera disposed and laterally-oriented along said body at or proximal to said tip so to capture lateral images from within the surgical cavity, wherein said lateral images are externally communicable to associate respective inner-cavity images with tracked tool tip locations, and the surgical tool further comprises at least one complementary camera disposed along said body at or proximal to said tip so to capture complementary images of the surgical cavity along a complementary imaging axis angled downwardly relative to said laterally-oriented camera so to construct a 3D inner-cavity mapping or an enlarged field of view image of the surgical cavity from said lateral images and said complementary images.
In accordance with some embodiments of the present disclosure embodiment, at least one of: the surgical cavity is visibly accessible to an external camera or scope aligned therewith, and wherein said inner-cavity images are complementary to external images captured by said external camera or scope in enhancing inner-cavity visualization, the tip is movable within the cavity to track pressure variations resulting from inner-cavity bleeding in locating a bleeding site within the cavity, and the tool body comprises a reusable tool shaft portion and a disposable tool tip portion removably operatively connectable to said shaft portion, wherein said tip portion comprises said tip and said pressure sensor.
In accordance with another aspect, there is provided a surgical system for performing surgery through an externally accessible surgical cavity, the system comprising: a surgical tool comprising: a rigid elongate tool body having a substantially rigid tool tip to be displaced and tracked within the surgical cavity so to reproducibly locate said tool tip within the cavity; and a pressure sensor operatively disposed along said body at or proximal to said tool tip and responsive to pressure variations applied thereto from within the surgical cavity to output a sensor signal representative thereof as the tool is displaced within the cavity; an external tracking system operatively interfacing with said surgical tool to automatically track a location of said tool tip within the cavity; and an external data processing unit operable to associate a given pressure reading associated with said sensor signal with a corresponding location of said pressure sensor within the cavity.
In accordance with some embodiments of the present disclosure embodiment, at least one of: the system further comprises a set of fiducial markers externally coupled in a fixed configuration to an externally extending portion of said elongate body, and wherein said markers are trackable by an external surgical navigation system to automatically associate said corresponding location of said pressure sensor within the cavity based on a respectively tracked position of said markers, and the pressure sensor is laterally oriented relative to said tip.
In accordance with another aspect, there is provided a surgical tool for use within a surgical cavity, the surgical tool comprising: a rigid elongate tool body having a substantially rigid tool tip to be displaced and tracked within the surgical cavity so to reproducibly locate said tool tip within the cavity; and at least one laterally-oriented camera operatively disposed along said body at or proximal to said tip so to capture lateral inner-cavity images of the surgical cavity for output as the tool is displaced within the cavity, wherein said lateral inner-cavity images are externally communicable to associate respective lateral inner-cavity images with tracked tool tip locations.
In accordance with some embodiments of the present disclosure embodiment, at least one of: the surgical tool further comprises a set of fiducial markers externally coupled in a fixed configuration to an externally extending portion of said elongate body, wherein said markers are trackable by an external tracking system to automatically determine said tracked tool tip locations with reference to the cavity based on a respective tracked position of said markers, the surgical tool further comprises a radio frequency transmitter to wirelessly communicate said lateral inner-cavity images, and the surgical tool further comprises a suction tool at or proximal to said tip to concurrently provide suction within the surgical cavity around said tip.
In accordance with some embodiments of the present disclosure embodiment, at least one of: the surgical tool further comprises at least one complementary camera disposed along said body at or proximal to said tip so to capture complementary images of the surgical cavity along a complementary imaging axis angled downwardly relative to said laterally-oriented camera so to construct a 3D inner-cavity mapping or an enlarged field of view image of the surgical cavity from said lateral images and said complementary images, the surgical cavity is visibly accessible to an external camera or scope aligned therewith, and said inner-cavity images are complementary to external images captured by said external camera or scope in enhancing inner-cavity visualization, and the tool body comprises a reusable tool shaft portion and a disposable tool tip portion removably operatively connectable to said shaft portion, wherein said tip portion comprises said tip and said camera.
In accordance with another aspect, there is provided a surgical system for performing surgical procedures via a surgical cavity, the system comprising: a surgical tool comprising: a rigid elongate tool body having a substantially rigid tool tip to be displaced and tracked within the surgical cavity so to reproducibly locate said tool tip within the cavity; and at least one laterally-oriented camera operatively disposed along said body at or proximal to said tip so to capture lateral inner-cavity images of the surgical cavity for output as the tool is displaced within the cavity, wherein said lateral inner-cavity images are externally communicable to associate respective lateral inner-cavity images with tracked tool tip locations; an external tracking system operatively interfacing with said surgical tool to automatically track a location of said tool tip within the cavity; and an external image processing unit operable to associate a given lateral inner-cavity image captured via said camera with a corresponding location of said camera within the cavity.
In accordance with some embodiments of the present disclosure embodiment, at least one of: the system further comprises an external imaging device axially aligned with the surgical cavity to capture downward images thereof; wherein said image processing unit is further operable to concurrently render downward images and lateral images of the surgical cavity as the surgical tool is moved, the camera has a footprint no greater than about 2 mm×2 mm, or no greater than about 1 mm×1 mm, the camera operates in a spectral region selected from visible and a near infrared, the surgical cavity is at least partially defined by a surgical port.
In one embodiment, the system further comprises a set of fiducial markers externally coupled in a fixed configuration to an externally extending portion of said elongate body; wherein said markers are trackable by said external tracking system to automatically determine said tracked tool tip locations with reference to the cavity based on a respective tracked position of said markers.
In one embodiment, the image processing unit is further operable to map an internal region of the surgical cavity by digitally assembling a set of said lateral images corresponding to said region and mapped thereto via each said corresponding location.
In one embodiment, the tool further comprises at least one complementary camera disposed along said body at or proximal to said tip so to capture complementary images of the surgical cavity along a complementary imaging axis angled downwardly relative to said laterally-oriented camera so to construct a 3D inner-cavity mapping or an enlarged field of view image of the surgical cavity from said lateral images and said complementary images.
Referring to FIGS. 1 and 2, together, this diagram illustrates a port-based surgical system incorporating a sensored surgical tool, and in accordance with embodiments of the present disclosure. The sensored surgical tool is described herein within the context of a port-based surgical system and associated tracking/navigation system, may also be amenable to other similar or alternate surgical systems and procedures, and that, without departing from the general scope and nature of the present disclosure. The utility and applicability of the herein-described sensored surgical tool is not limited to port-based and/or neurological procedures, but rather, may prove particularly useful and desirable in a number of surgical environments in which one or more tracked surgical tools are to be operated within a given surgical cavity where inner-cavity imaging and/or characterization is otherwise obscured or hidden from the surgeon or other medical practitioner.
Still referring to FIGS. 1 and 2, together, in the illustrated examples, the surgical system encompasses an exemplary surgical navigation system 200 operable to track various patient reference devices, in an environmental context, such as an operation room (OR). The system 200 supports, facilitates, and enhances minimally invasive access port-based surgery using a minimally invasive access port-based surgical procedure, though non port-based procedures may equally be considered herein as noted above.
Still referring to FIGS. 1 and 2, together, by example only, a surgeon 101 conducts a minimally invasive access port-based surgery on a subject, such as a patient 102, in an OR environment. The navigation system 200 generally includes an equipment tower 201, a robotic arm 202 to support an external optical scope 204, and at least one display or monitor 205, 211 for respectively displaying video images 205 a, 211 a. By example only, an operator 103 is also present to operate, control, and provide assistance for the system 200.
Referring to FIG. 2, the equipment tower 201 is generally mountable on a frame, e.g., a rack or a cart, and is configured to accommodate a power supply, e.g., an AC adapter power supply, and at least one computer or controller operable by at least one a set of instructions, storable in relation to at least one non-transitory memory device, corresponding to at least one of surgical planning software, navigation/tracking software, or robotic software for managing at least one of the robotic arm 202 and at least one instrument, such as a surgical instrument, e.g., the access port 206, the introducer 210, and/or one or more other downstream (instrumented) surgical tools (not shown) used during the procedure. For example, the computer comprises at least one of a control unit and a processing unit, such as control and processing unit 400 or 1530, as respectively shown in FIGS. 8 and 3.
Still referring to FIG. 2, in the illustrated embodiment, the equipment tower 201 comprises a single tower configured to facilitate coupling of the at least one display device, e.g., a primary display device 211 and a secondary display device 205, with the at least one piece of equipment. However, other configurations are also encompassed by the present disclosure, such as the equipment tower 201 comprising dual towers configured to facilitate coupling of a single display, etc. The equipment tower 201 is also configurable to accommodate an uninterruptible power supply (UPS) for providing emergency power.
Still referring to FIG. 2, to maintain constant positioning of the patient's anatomy of interest during a given procedure, the patient's anatomy may be held in place by a holder appropriate for the procedure in question. For example, in a port-based neurosurgical procedure, a patient's head can be retained by a head holder 217. A craniotomy is performed; and a dura flap is formed and retracted. The access port 206 and the introducer 210 can then be inserted into the patient's brain 102 b; and the planned procedure is executed while the patient's head remains effectively immobile.
Still referring to FIG. 2 and referring back to FIG. 1, the system also includes a tracking system 213 that is generally configured to track at least one instrument, such as a surgical instrument or tool. The tracking system is initially utilized to track the access port 206 and the introducer 210 while the access port is being introduced within the patient's brain so to ultimately locate and define the surgical site and surrounding surgical cavity. However, other sensored or non-sensored intraoperative surgical tools, such as, but not limited to, inner-cavity pointing tools, suction tools, tissue probes, e.g., Raman, OCT probes, etc., resection tools and the like, are also advantageously tracked by the tracking system to enhance accuracy and precision of executed operative procedures. Instrument tracking can thus significantly assist the surgeon 101 during the minimally invasive access port-based surgical procedure (or like procedures) both in guiding and confirming procedural actions, but also in aligning real-time surgical cavity imaging and characterization, as detailed below within the context of tip-sensored surgical tools, with preoperative imaging data and intraoperative external imaging, e.g., captured via external optical scope 204 and/or other cameras discussed below. Accordingly, tracking sensored tools such as pointing and/or suction tools can significantly benefit enhanced or complementary inner-cavity imaging, localization, characterization and/or mapping.
Still referring to FIG. 2, accordingly, the tracking system 213 is configured to track and determine, e.g., in real-time by way of a set of instructions corresponding to tracking software and storable in relation to at least one non-transitory memory device, the location of the one or more tracked instruments during the surgical procedure, while also generally tracking a position of the robotic arm 202. The tracking system 213 generally comprises at least one sensor (not shown) for detecting at least one fiducial marker 212 disposable in relation the one or more OR items, e.g., surgical arm 202, and/or surgical instruments (introducer 210) to be tracked. In one example, the tracking system 213 comprises a three-dimensional (3D) optical tracking stereo camera, such as a Northern Digital Imaging® (NDI) optical tracking stereo camera, which can be configured to locate reflective sphere tracking markers 212 in 3D space.
Still referring to FIG. 2, in another example, the tracking camera 213 comprises a magnetic camera, such as a field transmitter, where receiver coils are used to locate objects in 3D space. Accordingly, location data of the mechanical arm 202, the access port 206, the introducer 210, and its associated pointing tool, and/or other tracked instruments/tools, may be determined by the tracking camera 213 by automated detection of tracking markers 212 placed on these tools, wherein the 3D position and the orientation of these tools is effectively inferred and tracked by tracking software from the respective position of the tracked markers 212.
Still referring to FIG. 2, the secondary display 205 provides an output of the tracking camera 213, which may include, but is not limited to, axial, sagittal and/or coronal views as part of a multi-view display, for example, and/or other views as may be appropriate, such as views oriented relative to the at least one tracked instrument, e.g., perpendicular to a tool tip, in-plane of a tool shaft, etc. These and other views may be considered in various single or multi-view combinations, without departing from the general scope and nature of the present disclosure.
Still referring to FIG. 2, minimally invasive brain surgery using access ports is a recent method of performing surgery on brain tumors. In order to introduce an access port 206 into a brain, such as the patient's brain 102 b, of a patient's head 102 a, an introducer, e.g., the introducer 210, comprises an atraumatic tip disposable within the access port 206 to facilitate positioning the access port 206 within the patient brain 102 b. The introducer 210 further comprises at least one fiducial marker 212 for facilitating tracking by the tracking system 213. Generally, tracked tools, such as introducer 210, include a plurality of fiducial markers to enhance trackability in 3D space.
Still referring to FIG. 2, after the introducer 210 and the access port 206 are inserted into the brain 102 b, the introducer 210 is removed to facilitate access to the tissue of the brain 102 b through the central opening of the access port 206. However, after the introducer 210 is removed, the access port 206 is no longer being tracked by the tracking system 213. However, the access port 206 is indirectly trackable by way of additional pointing tools (not shown) configured for identification by the navigation system 200.
Still referring to FIG. 2, the navigation system 200 further comprises a guide clamp 218 for retaining the access port 206. The guide clamp 218 is configured to optionally engage and disengage the access port 206, eliminating the need to remove the access port 206 from the patient 102. In some embodiments, the access port 206 is configured to slide up and down within the guide clamp 218 in a closed position. The guide clamp 218 further comprises a locking mechanism (not shown), the locking mechanism being attachable or integrable in relation to the guide clamp 218, and the locking mechanism being optionally manually actuatable, e.g., using one hand as further below described.
Still referring to FIG. 2, the navigation system 200 further comprises an articulating arm 219, such as a small articulating arm, configured to couple with the guide clamp 218. The articulating arm 219 comprises up to six (6) degrees of freedom for facilitating positioning of the guide clamp 218. The articulating arm 219 is attachable at a location in relation to the head holder 217, or in relation to any other suitable patient support structure, to ensure, when locked in place, that the guide clamp 218 is fixed in relation to the patient's head 102 a. The articulating arm 219 comprises an interface 219 a disposable in relation to the guide clamp 218, wherein the interface 219 a is at least one of flexible or lockable into place. Flexibility of the interface 219 a facilitates movability of the access port 206 into various positions within the brain 102 b, yet still maintains rotatability about a fixed point.
Still referring to FIG. 2, the navigation system 200 further, or alternatively, comprises a plurality of wide-field cameras, e.g., two additional wide-field cameras (not shown) being implemented with video overlay information, wherein one camera is mountable in relation to the optical scope 204 and the other camera is mountable in relation to the navigation system 213, e.g., within the context of an electromagnetic tracking system. In the case of the navigation system 213 comprising an optical tracking device, a video image can be directly extracted therefrom. Video overlay information can then be used to enhance available intraoperative information, for example, by providing an image displaying a physical space and confirming tracking system registration alignment and optional corresponding text and/or indicia, an image displaying a motion range of the robotic arm 202 holding the optical scope 204 and optional corresponding text and/or indicia, and/or an image displaying a guide head positioning and a patient positioning and optional corresponding text and/or indicia.
Referring to FIGS. 3, 4A, and 4B, together, FIG. 3 is a schematic diagram illustrates a sensored surgical tool and associated control and processing unit, in accordance with an embodiment of the present disclosure, FIG. 4A is a schematic cross-sectional view of a disposable tool tip portion of the sensored surgical tool, as shown in FIG. 3, in accordance with an embodiment of the present disclosure, and FIG. 4B is a schematic top plan view of the disposable tool tip portion, as shown in FIG. 4A, in accordance with an embodiment of the present disclosure. Other image overlays, as below described in greater detail, further comprise intraoperative cavity imaging and/or characterization data, e.g., colour mapping, partial image transparency overlay, text and/or indicia, such as provided by a sensored tool, for example including, but not limited to, real-time inner cavity images, e.g., visible, near infrared (IR), etc., provided by tool tip mounted camera(s), real-time inner cavity pressure readings (e.g., localized fluid pressure readings, pressure gradients, pressure mappings, etc.) provided by tool tip mounted pressure sensor(s) and/or sensor arrays, and other such readings of interest given the application at hand. Using such real-time intraoperative inner cavity imaging and characterization data may not only enhance other intraoperative images, such as those rendered by overhead scopes and/or cameras, but also seamlessly integrate with preoperative images and/or data, for instance, acquired pre-operatively using one more imaging techniques. Accordingly, the surgeon and/or other surgical equipment operator can execute procedures and/or actions with greater clarity, certainty and visibility, thus leading to improved outcomes and risk reduction.
Referring to FIG. 5, this diagram illustrates an access port-based surgical procedure conducted by way of the navigation system 200, in accordance with an embodiment of the present disclosure. In this example, a surgeon 501 is resecting a tumor from the brain of a patient 502 through an access port 504. An external scope 505 is coupled with a robotic arm 504, and is used to view down port 504 at a sufficient magnification to allow for enhanced visibility down port 504. The output of external scope 505 is rendered on a visual display.
Referring to FIG. 5, the procedure involves disposing active or passive fiduciary markers, respectively, 507, 508, e.g., spherical markers, in relation to at least one of the access port 504 or the external scope 505 for facilitating their tracking (location of these tools) by the tracking system, e.g., tracking system 213, as shown in FIG. 2. The active or passive fiduciary markers 507, 508 are sensed by sensors of the tracking system 213, whereby identifiable points are provided. A tracked instrument is typically indicated by sensing a grouping of active or passive fiduciary markers 507, 508, whereby a rigid body, such as a tool, is identified by the tracking system 213, and whereby the position and orientation in 3D of a tracked instrument, such as a tool, is determinable. A substantially rigid tool is tracked in 3D space to effectively locate and orient the tool and its various segments and constituent components, provided such segments/components are previously defined and stored against the tracked tool type. Accordingly, a tracked tool invokes not only general tracking, but also tracking, for example, of the tool's tip or body, and any sensors, as will be detailed below, that may be operatively coupled thereto in a designated configuration, e.g., at or near a tool tip, angled relative to a tool tip or shaft, displaced and/or angled relative to other tool-mounted sensors, etc. Typically, a minimum of three active or passive fiduciary markers 507, 508 are placed on a tracked tool to define the instrument. In the several figures included herewith, four active or passive fiduciary markers 507, 508 are used to track each tool, by example only.
Still referring to FIG. 5, in one particular example, the fiduciary markers comprise reflective sphere markers in combination with an optical tracking system to determine spatial positioning of the surgical instruments within the operating field. The spatial position of automated mechanical arm(s) or robotic arm(s) used during surgery may also be tracked in a similar manner. Differentiation of the types of tools and targets and their corresponding virtual geometrically accurate volumes can be determined by the specific orientation of the reflective spheres relative to one another giving each virtual object an individual identity within the navigation system. The individual identifiers can relay information to the system as to the size and virtual shape of the tool within the system. The identifier can also provide information such as the tool's central point, the tools' central axis, the tool's tip, etc. The virtual tool may also be determinable from a database of tools provided to the navigation system 200. The marker positions can be tracked relative to an object in the operating room such as the patient. Other types of markers that can be used may include, but are not limited to, radio frequency (RF), electromagnetic (EM), pulsed and un-pulsed light-emitting diodes (LED), glass spheres, reflective stickers, unique structures and patterns, wherein the RF and EM would have specific signatures for the specific tools to which they would be attached. The reflective stickers, structures, and patterns, glass spheres, LEDs could all be detected using optical detectors, while RF and EM could be detected using antennas. Advantages to using EM and RF tags may include removal of the line of sight condition during the operation, where using the optical system removes the additional noise from electrical emission and detection systems.
Still referring to FIG. 5, in a further embodiment, printed or 3D-configuration markers are used for detection by an auxiliary camera and/or external scope. The printed markers are also used as a calibration pattern to provide distance information (3D) to the optical detector. These identification markers comprise distinct configurations, such as concentric circles with different ring spacing, and/or different types of bar codes. Furthermore, in addition to using markers, the contours of known objects, e.g., side of the port, top ring of the port, shaft of pointer tool, etc., can be made recognizable by the optical imaging devices through the tracking system 213. Similarly, or in addition thereto, structural information relating to each tool (size, dimensions, distance and geometric orientation relative to markers) is used to extrapolate the position and orientation various tool segments, such as the tool tip, and various sensors that are operatively mounted thereon or associated therewith.
Still referring to FIG. 5, while a number of tracking techniques and related marker types are herein listed, other techniques, including future techniques, are considered within the present disclosure to support and enhance operation of the tracked surgical tools, e.g., sensored tools, as herein described. The tracking technique for each instrument generally enables tracking of the instrument's position and orientation within a given frame of reference, in which the position and the orientation can be tracked, relayed, and/or rendered on the surgical system's one or more displays to visually locate the tool, or data/images acquired thereby, within the context of the procedure taking place and/or any otherwise available preoperative and/or intraoperative images/details.
Referring to FIG. 6A, this diagram illustrates, in a perspective view, a trackable tool, such as a tracked pointing tool 601, having distinctly configured tracking markers, such as a set of tracking markers 610, in accordance with an embodiment of the present disclosure. The tool 601 comprises a rigid pointer or pointing tool 600 rigidly coupled with a set of tracking markers 610 fixedly disposed relative thereto in a designated configuration geometry that is recognizable by the tracking system, e.g., tracking system 213, as shown in FIG. 2, in accordance with an embodiment of the present disclosure. In this example, the markers 610 are fixedly coupled with the tracked pointing tool 600 via respective connector beams 615 attached to respective laterally extending arms 620 forming a box-like configuration in a plane of the tool's handle 625.
Referring to FIG. 6B, this diagram illustrates, in a perspective view, a trackable tool, such as a tracked surgical tool 602, having distinctly configured tracking markers, such as a set of tracking markers 610, in accordance with an embodiment of the present disclosure. The surgical tool 602, again is defined by a pointer or pointing tool 640 and related tracking markers, such as a set of 610; however, in this embodiment, the tracked surgical tool 602 is rigidly coupled with the pointing tool 640 via a laterally splayed support arm structure 642.
Referring to FIG. 6C, this diagram illustrates, in a perspective view, a trackable tool, such as a tracked surgical tool 603, having distinctly configured tracking markers, such as a set of tracking markers 610, in accordance with an embodiment of the present disclosure. The tracked surgical tool 603 is defined by a pointer or pointing tool 650 and related tracking markers, such as the set of markers 610, and is rigidly coupled with the pointing tool 650 via an intersecting support arm structure 652.
Referring to FIG. 6D, this diagram illustrates, in a perspective view, a trackable pointing tool, such as a tracked surgical tool 604, having distinctly configured tracking markers, such as a set of tracking markers 610, in accordance with an embodiment of the present disclosure. The tracked surgical tool 604 is defined by a pointer or pointing tool 660 and related tracking markers, such as the set of markers 610, and is time rigidly coupled with the pointing tool 660 via a T-shaped support arm structure 662.
Referring back to FIGS. 6A-6D, in each of the examples shown therein, the tracked tool comprises a pointing tool, although other surgical instruments may also be used and encompassed by the present disclosure to provide a like effect. For instance, a suction or resection tool, or other surgical probe, may also be considered in which tracking is effectively provided by appropriate markers and a tracking system, and whereby a position and orientation of the tracked tool may be adequately tracked, relayed and rendered during the procedure. As detailed further below, the further instrumentation of the surgical tool, e.g., sensored tool tip, either a pointing or other tool, to acquire inner-cavity data and/or images, as considered herein, may also apply to enhance real-time intraoperative data/imaging resources.
Referring to FIGS. 6E-6H, together, FIG. 6E is a diagram illustrating a perspective view of a trackable surgical access port having a set of tracking markers, FIG. 6F is a diagram illustrating a front elevation view of a trackable surgical access port having a set of tracking markers, FIG. 6G is a diagram illustrating a side view of a trackable surgical access port having a set of tracking markers, and FIG. 6H is a diagram illustrating a top plan view of a trackable surgical access port having a set of tracking markers, in accordance with embodiments of the present disclosure.
Still referring to FIGS. 6E-6H, together, for completeness, other surgical devices may also be intraoperatively tracked, as noted above. For example, these figures respectively provide perspective, front elevation, side and top plan views of a surgical port 680 rigidly associated with a corresponding set of markers 610 coupled therewith via a support structure 682. The arrangement enables clear visibility of the fiducial or tracking markers 610 to the tracking system 213, while ensuring that the markers 610 do not interfere with surgical tools that are inserted through the access port 680. The non-uniform structure of the extended arm 682 for the markers 610 enables the tracking system 213 to discern both the position and the orientation of the access port 680 in response to instructions corresponding to the tracking software, for example.
Referring to FIG. 7, this diagram illustrates, in a perspective view, the pointing tool 603, as shown in FIG. 6C, engaged with a trackable access port 690, whereby the tracking markers 610 rigidly associated with the pointing tool 650 via support structure 652 are automatically discernible by the tracking/navigation system from the tracking markers 692 rigidly associated with the access port 690 via distinct support structure 694, in accordance with an embodiment of the present disclosure. Accordingly, the pointing tool 650 and access port 690 are separately trackable by the tracking system 213 of the navigation system 200 and are differentiable as unique objects in images rendered on the display device 205.
Still referring to FIG. 7, as noted above, by mapping each instrument's position and orientation, the tracking system, e.g., system 213, as shown in FIG. 2, also generally extrapolates a location and orientation of the instrument's various segments, such as an instrument's tip, for example, when located and used within the surgical cavity, e.g., down-port location and orientation in the context of a port based procedure. Accordingly, by instrumenting the tip or other segment of a trackable tool, instrumentation-related (sensor) data may also be dynamically associated with the tracked position and orientation of the tool, e.g., the tool tip, and effectively mapped in relation thereto even when the tool tip location is obscured to the external viewer/scope. Therefore, a tracked sensored tool, e.g., the tool tip, provides real-time intraoperative visibility otherwise unavailable by using preoperative imaging and intraoperative external scope or camera view angles. Using video and image overlays, as herein described, tracked tool tip instrumentation may further accentuate available intraoperative data by enhancing real-time data available during the procedure, which is otherwise unavailable using an external scope and cameras.
Still referring to FIG. 7, for example, a tracked sensored tool tip may be enhanced via the disposition of one or more cameras, e.g., miniature camera with a micro lens, at the tool tip to provide real-time intraoperative inner-cavity or down-port (within the context of a port-based procedure) images. For example, such down-port or inner-cavity real-time visible intraoperative imaging may allow for the real-time capture of otherwise obscured or challenging inner-cavity views.
Still referring to FIG. 7, alternatively, or in combination therewith, the tracked tool tip may be sensored with one or more sensors, e.g., micro-sensors, such as a pressure sensor or the like to capture distinct or further inner-cavity or down-port characterizations otherwise unavailable. For example, a tracked displaceable down-port or inner-cavity pressure sensor may allow for the effective location of an obscured bleeding site, for example, which can then be more effectively addressed, e.g., via bipolar or other method, as compared to current methods, which generally require a blind or mostly obscured visual extra-cavity assessment. These examples will be expanded on further below, with reference to specific embodiments.
Referring back to FIG. 3, a sensored surgical tool, e.g., a tool 1500, generally comprises a rigid elongate tool body 1502 having a substantially rigid tool tip 1504. In this embodiment, the tip 1504 forms part of a detachable/disposable sensored tool tip portion 1506 and is operatively coupled partway up the tool body 1502, e.g., with a tool shaft or rod 1503. The tool shaft 1503 integrally leads to a tool body handle 1508 and tracking portion, such as tracking marker tree 1510 encompassing a set of configurationally and recognizably predisposed tracking markers 1512, e.g., fiducial markers, such as those described and shown in relation to FIGS. 6A-6D.
Still referring back to FIG. 3, for instance, the tool's tracking marker tree 1510 comprises a set of tracking markers 1512 rigidly mounted in a distinctly recognizable geometric configuration via a designated support structure, e.g., an instrument-specific marker configuration and/or type for automated tool type recognition and comprehensive real-time tracking/display. The various tracking techniques, marker types and configurations described above are equally applicable in this example.
Still referring back to FIG. 3, the tool's body handle 1508 is configured and adapted for its intended use, either for manual operation or for guided or automated operation by a robotic arm or the like, that is, amenable for operative coupling to a robotic arm coupler, grip or clasp, as the case may be. In this particular example, the body handle 1508 and tracking portion 1510 are shaped and oriented relative to the tool body shaft 1503 and tip portion 1506 so to remain visible to the tracking system, e.g., optical tracking system 213, as shown in FIG. 2, and related overhead camera(s), while limiting a potential obstruction thereof to the external scope and/or cameras, e.g., so not to overly obstruct a surgeon's external overhead view angles. These and other tracking portion configurations, as shown in FIGS. 6A-6D, may be considered.
Referring back to FIGS. 4A and 4B, the detachable/disposable tip portion 1506 comprises one or more tool tip sensors, the tool tip sensors comprising one or more imaging sensors, such as cameras 1516, one or more pressure sensors 1518, or like pressure-sensitive transducers. Each camera and/or sensor is operatively mounted at or near the tip 1504 to capture inner-cavity images and/or measurements, respectively, which can be relayed in real-time, in this embodiment, via respective embedded wiring 1520 and corresponding contacts 1521, e.g., quick connect contact points, operatively disposed on the detachable tip portion 1506 to cooperate with corresponding contacts (not shown) and wiring on the reusable tool body shaft 1503 (FIG. 3). Different types of contacts 1521 may be considered, such as pressure-fitting or magnetized contacts, or again touch contact spots solidly connected via a cooperative engagement or coupling linking the removable tip portion 1506 and tool body shaft 1503, e.g., snap coupling, pressure-fitted coupling, mating engagement fitting, etc. These and other contact and component coupling techniques is readily applied within the context of the illustrated embodiment without departing from the general scope and nature of the present disclosure. Likewise, while distinct “four-channel” contacts are illustrated to communicatively link the various tool tip sensors to the RF transmitter via respective wiring, different signaling configurations are also be encompassed, such as joint cabling and connector configurations, as well as multiplexing data channeling configurations relying, at least in part, on tip-based data preprocessing and communication hardware, for example.
Still referring back to FIGS. 4A and 4B, while not explicitly illustrated, appropriate power can also be delivered to the sensors, as appropriate, to operate same. Likewise, an appropriate illumination source, such as a miniature LED light source or the like, may be directly mounted at, near or in relation to the tip, or the illumination thereof relayed thereto via an appropriate waveguide or fiber, as needed, and as will be readily appreciated by the skilled artisan, to provide appropriate illumination for image capture if such illumination is not sufficiently available from external illumination sources.
Referring back to FIGS. 3, 4A, and 4B, in the illustrated embodiment, the embedded wiring is routed to a wireless communication device, for instance comprising a radio frequency (RF) antenna 1522 and RF circuitry 1524 operable to relay data signals produced by the tip sensor(s) 1516, 1518 to a corresponding RF receiver and antenna 1526 associated with a (wireless) input/output (I/O) device and interface 1527 and related communication interface(s) 1528 of the surgical system's control and processing unit 1530, or a subcomponent or module thereof, for example.
Still referring back to FIGS. 3, 4A, and 4B, for instance, sensor data signals can be processed, e.g., via processor 1532 and memory 1534 of the processing unit 1530, in conjunction with the system's tracking/navigation system 1536 and related image processing and display functions, e.g., schematically depicted as display submodule 1538, in real-time for display alone or in combination with one or more other procedure-related visualizations, e.g., preoperative and/or intraoperative image overlays, pressure data mappings and/or localizations, etc. Tool tip inner-cavity imaging and/or pressure characterizations are externally communicated via the illustrated wiring 1520 and RF communication hardware 1524, 1522, or again via other direct or indirect communication means, such as via one or more electrical, optical and/or wireless data relays, and the like, embedded or, otherwise, operatively coupled with the sensored tool 1500.
Still referring back to FIGS. 3, 4A, and 4B, the detachable tool tip portion 1506 comprises a rigid, e.g., metal or plastic, sheath 1542 within which the sensor wiring 1520 is embedded or relayed, and which forms the surface of the tip 1504 that interfaces with the patient's inner-cavity, e.g., down-port, tissues/fluids. Embedded within, on, and/or through this sheath 1542 toward the tip 1504, e.g., on or at least partly embedded within or through a laterally, or mostly laterally, oriented surface of the sheath tip portion 1506 at or toward the tip 1504, are located the camera(s) 1516 and/or pressure sensor(s) 1518 in operative connection with their respective wiring 1520.
Still referring back to FIGS. 3, 4A, and 4B, the tip portion 1506 includes two cameras 1516 juxtaposed lengthwise along and toward the tip 1504 such that the camera closest to the tip 1504 is angled (A) longitudinally/downwardly, e.g., toward a cavity bottom in operation, relative to the camera farthest from the tip 1504. This configuration allows, in some examples, for distinct inner cavity intraoperative view angles that can, when processed, provide different down-cavity view-points to enhance visibility and a visual explorative imaging capacity of the sensored tool 1500 (FIG. 3), and/or be combined to construct, or contribute to the construction of, a 3D intraoperative down-cavity image. For example, one camera of the cameras is particularly oriented to capture surgical cavity sidewall images, whereas the other camera of the cameras seeks to predominantly capture cavity bottom views. In some examples, images captured from respective tip cameras can be stitched together to enlarge a field of view of the cavity sidewall. In different embodiments, the two cameras may be juxtaposed side-by-side, on opposite sides of the tip 1504, or consist of a single tip camera, to name a few examples.
Still referring back to FIGS. 3, 4A, and 4B, the tip portion 1506 further includes at least one, and in this case two, pressure sensors 1518, one disposed on either side of the longitudinally disposed cameras 1516. Again, distinct pressure readings may be used to provide distinctly localized pressure readings, combined to provide an average reading corresponding to a general location of the tip 1504, or used and/or processed in different combinations, such as to compute real-time localized pressure gradients and/or variations, to name a few examples. A pressure sensor array may also be used to further enhance pressure reading versatility. As for the images relayed from the cameras 1516, pressure readings are used to pinpoint localized pressure readings of interest, e.g., anomalously high pressure readings, such as corresponding to a bleeding site or the like, sharp pressure gradients leading to anomalous down-cavity issues, again such as a bleeding site, etc., or again generate a localized down-cavity pressure mapping, with such results ultimately displayable alone or in concert with other preoperative and/or intraoperative images, readings and/or measurements. Again, while two pressure sensors 1518 are shown, a single pressure sensor or a plurality of pressure sensors in varying configurations may be used to enhance pressure readings and sensory data complexity. For example, a pressure sensor array is used to more accurately map pressure variations within the cavity and, thus, more readily pinpoint a bleeding site, e.g., from a vein or artery hole, for example, or other anomalous pressure point.
Still referring back to FIGS. 3, 4A, and 4B, various cameras are amenable for use in the embodiments of the present disclosure, provided that such various cameras have a sufficiently small footprint to accommodate the size and area available at the tool tip 1504. For example, a complementary metal oxide semiconductor (CMOS) camera with an integrated micro lens is particularly amenable for use in embodiments of the present disclosure to generate high-resolution inner cavity images. For example, the minimal form factor image sensor NanEye 2D by Awaiba® (http://www.cmosis.com/products/product_detail/naneye) provides one example of a system on a chip camera having a footprint of approximately 1 mm². For a tool tip portion having a diameter in a range of approximately 4 mm to approximately 5 mm, a camera footprint of this order is suitable, even when combining two cameras and two pressure sensors in the same tip area. Clearly, where a single camera is used, a larger footprint, for example in a range of at least approximately 4 mm²is suitable.
Still referring back to FIGS. 3, 4A, and 4B, furthermore, each of the one or more cameras may consist of self-contained camera units, thus comprising any and all circuitry to implement the camera and capture images, e.g., pixelated/digital images, therewith, as well as any necessary optics, e.g., micro lens, integrally formed therewith. In other embodiments, additional components, such as external lenses or the like, may be provided, for example within the sheath illustrated herein, or again, as an add-on component, to provide a desired imaging effect. Generally, the camera(s) will be sealed in a waterproof configuration to ensure proper operation within the surgical environment and reduce the likelihood of camera failures. Likewise, while identical though distinctly oriented cameras are shown in the illustrated embodiments, different camera characteristics may be considered to provide complementary effects, e.g., narrow angle lens vs. wide angle lens, different image spectrum sensitivity such as narrow band vs. broadband and/or visible vs. near infrared cameras, etc. Furthermore, while not explicitly illustrated, the sensored tip further comprises an integrated illumination device, such as a miniature LED light source or the like to provide required or complementary, e.g., complementary to external illumination, inner-cavity illumination for effective image capture. In yet another example, the tool further comprises a directional light source such as a laser light source to gauge a distance to the imaged or characterized tissue by measuring reflected laser light travel times, for example.
Still referring back to FIGS. 3, 4A, and 4B, likewise, different pressure sensor technologies may be invoked to provide an appropriate tool tip sensor. For example, different Fabry-Perot, piezoresistive, nanotube and/or optical microelectromechanical (MEMS) pressure sensors may be amenable to the herein-described application. Examples of such sensors are respectively described by G. C. Hill, et al. 2007, SU-8 MEMS Fabry-Perot pressure sensor, Sensors and actuators A 138(2007) 52-62; Jialin Yao, et al., 2016, A flexible and highly sensitive piezoresistive pressure sensor based on micropatterned films coated with carbon nanotubes, Journal of Nanomaterials, Volume 2016; and Yixian Ge, et al., An optical MEMS pressure sensor based on a phase demodulation method, Sensors and actuators A 143(2008) 224-229; the entire contents of each of which are hereby incorporated herein by reference. Other pressure sensor types may also be considered, without departing from the general scope and nature of the present disclosure.
Still referring back to FIGS. 3, 4A, and 4B, as noted above, other surgical tools are effectively sensored and tracked by the surgical system's tracking hardware to provide enhanced inner cavity characterization and/or imaging. For example, a suction tool is used when the surgical cavity is immersed in blood or fluid in order to seek out a bleeding or leaking site to be addressed. Accordingly, such suction tool may be advantageously fitted with one or more cameras and/or pressure sensors, as noted above, to improve inner cavity assessment while using the tracked suction tool. Much like the pointing tool described herein, the suction tool comprises a sensored tip, e.g., laterally oriented sensors operatively mounted on an axially or opposing laterally directed suction tool. Alternatively, the suction tool may be combined with a distinct pointing tool portion, much as described above, to provide dual functions. Such as described above, a suction tool tip portion may consist of a disposable tip portion that may be replaced for each new procedure. Other surgical tools may equally benefit from sensor borne tool tips as described above, not only to improved inner cavity imaging/characterization intraoperatively, but also to accelerate certain surgical site processes by accurately imaging, locating and mapping inner cavity characteristics to be addressed or considered in real-time during the surgical procedure.
Referring back to FIG. 3, the illustrative control and processing unit 1530, which may consist of a standalone or subcomponent of an overall surgical system processing and control unit, may include, but is not limited to comprising one or more processors 1532 (for example, a CPU/microprocessor or a graphical processing unit, or a combination of a central processing unit or graphical processing unit), bus 1544, memory 1534, which may include random access memory (RAM) and/or read only memory (ROM), one or more internal storage devices 1546, e.g., a hard disk drive, compact disk drive or internal flash memory, a power supply 1548, one more communications interfaces 1528, optional external storage 1550, display image/data processing 1538, and one or more input/output devices and/or interfaces 1527, e.g., a wireless receiver/transmitter and antenna 1526, a speaker, a display, e.g., one or more displays 205, 211, as shown in FIG. 2, and/or a linked graphical user interface (GUI) or the like), an imaging sensor, such as those used in a digital still camera or digital video camera, a clock, an output port, a user input device, such as a keyboard, a keypad, a mouse, a position tracked stylus, a foot switch, and/or a microphone for capturing speech commands).
Still referring back to FIG. 3, the control and processing unit 1530 is programmed with programs, subroutines, applications or modules, which include executable instructions, which when executed by the processor, causes the system to perform one or more methods described in the disclosure. Such instructions may be stored, for example, in memory 1534 and/or internal storage 1546. In particular, in the exemplary embodiment shown, image processing module 1538 includes computer executable instructions for analyzing output tool tip sensor data (images and/or pressure readings). For example, computer readable instructions may be provided for processing image and/or pressure data obtained at different inner-cavity spatial locations and tool tip orientations in order to image/characterize otherwise potentially obscured regions of the surgical cavity. The spatial location/orientation may be correlated with the recorded image/pressure data via the tracking of the position and orientation of tool 1500, for instance tracked via illustrated tracking and navigation module 1536. For example, the tracking and navigation module 1536 may include executable instructions for processing tracking data, and/or for rendering a navigation user interface on a display, as above discussed.
Still referring back to FIG. 3, although only one of each unit component is illustrated, any number of each component can be included in the control and processing unit 1530. For example, a computer typically contains a number of different data storage media. Furthermore, although the bus 1544 is depicted as a single connection between all of the components, the bus 1544 may represent one or more circuits, devices, or communication channels which link two or more of the components. For example, in personal computers, the bus 1544 often includes or is a motherboard. Control and processing unit 1530 may include many more or less components than those shown. One or more external subsystems, such as a tool tip sensor data processing device, may be distinctly implemented and communicatively linked to an overall surgical system control and processing unit, or form an integral part thereof.
Still referring back to FIG. 3, in one embodiment, the control and processing unit 1530 may be, or include, a general purpose computer or any other hardware equivalents. The control and processing unit 1530 may also be implemented as one or more physical devices that are coupled with the processor 1532 through one of more communications channels or interfaces. For example, the control and processing unit 1530 is implemented using application specific integrated circuits (ASICs). Alternatively, control and processing unit 1530 is implemented as a combination of hardware and software, where the software is loaded into the processor from the memory or over a network connection.
Referring to FIG. 8, this schematic diagram illustrates a relationship among components of an overall surgical navigation system 200, such as a control and processing unit 400, a tracking system 213, a data storage device 442 for the tracking system 213, and system devices 420, and medical instruments 460, and medical tools, in accordance with an embodiment of the present disclosure. The control and processing unit 400 comprises at least one processor 402, a memory 404, such as a non-transitory memory device, a system bus 406, at least one input/output interface 408, a communications interface 410, and storage device 412. The control and processing unit 400, which may encompass or interface with control and processing unit 1530, as shown in FIG. 3, is interfaced with other external devices, such as the tracking system 213, the data storage device 442 for the tracking system 213, and the external user input and output devices 444, optionally comprising, for example, at least one of a display device, such as display devices 211, 205, a keyboard, a mouse, a foot pedal, a microphone, and a speaker.
Still referring to FIG. 8, the data storage 442 comprises any suitable data storage device, such as a local or remote computing device, e.g., a computer, hard drive, digital media device, or server, having a database stored thereon. The data storage device 442 stores identification data 450 for identifying at least one medical instrument 460 and configuration data 452 for associating customized configuration parameters with at least one medical instrument 460. The data storage device 442 further stores at least one of preoperative image data 454 and medical procedure planning data 456. Although the data storage device 442 is shown as a single device, in other embodiments, the data storage device 442 comprises multiple storage devices. The data storage device 442 is also configured to store data in a custom data structure corresponding to various 3D volumes at different resolutions, wherein each may be captured with a unique time-stamp and/or quality metric. This custom data structure provides the system 200 (FIGS. 1 and 2) with an ability to move through contrast, scale, and time during the surgical procedure.
Still referring to FIG. 8, the medical instruments (tools) 460 are identifiable by the control and processing unit 400, wherein the medical instruments 460 are coupled with, and controlled by, the control and processing unit 400. Alternatively, the medical instruments 460 are operable or otherwise independently employable without the control and processing unit 400. The tracking system 213 may be employed to track at least one of the medical instruments 460 and spatially register the at least one medical instrument 460 in relation to an intraoperative reference frame. The tracking system 213, thus, furnishes the requisite position, orientation, and location data to associate sensored tool data with corresponding locations within the surgical cavity.
Still referring to FIG. 8, the control and processing unit 400 is also interfaceable with a number of configurable devices, and intraoperatively reconfigure at least one such device based on configuration parameters obtained from configuration data 452. Examples of devices 420 include, but are not limited to, at least one external imaging device 422, at least one illumination device 424, robotic arm 202, at least one projection device 428, and at least one display device, such as display devices 211, 205.
Still referring to FIG. 8, the control and processing unit 400 is operable by the at least one processor 402 and the at least one memory 404. For example, the functionalities described herein are at least partially implemented via hardware logic in processor 402 by way of the instructions stored in memory 404 though at least one processing engine 470. Examples of processing engines 470 include, but are not limited to, user interface engine 472, tracking engine 474, motor controller 476, image processing engine 478, image registration engine 480, procedure planning engine 482, navigation engine 484, and context analysis module 486.
Still referring to FIG. 8 and referring back to FIGS. 1 and 2, understood is that the system 200 is not intended to be limited to the components shown in the several figures of the Drawing. One or more components of the control and processing 400 may be provided as an external component or device. In an alternative embodiment, the navigation module 484 is provided as an external navigation system that is integrated with the control and processing unit 400. Embodiments of the system 200, as shown in FIG. 2, may be implemented by using the processor 402 without additional instructions stored in the memory 404. Embodiments may also be implemented, using the instructions stored in the memory 404, for execution by one or more general purpose microprocessors.
Referring to FIG. 9, this schematic diagram illustrates a preoperative surgical planning system 900 for use with a navigation system 200, in accordance with an embodiment of the present disclosure. The preoperative surgical planning system 900 comprises components and inputs for planning and scoring surgical paths.
Referring to FIG. 10, this schematic diagram illustrates an intraoperative surgical management system 1000 for use with a navigation system 200, in accordance with an embodiment of the present disclosure. The intraoperative surgical management system 1000 comprises components and inputs for navigation along the surgical paths produced by the preoperative surgical planning system 900, as shown in FIG. 9. The intraoperative surgical management system 1000 are used as a surgical planning and navigation tool in the preoperative and intraoperative stages. Data input(s) of the surgical planning steps and surgical procedures, as shown in FIG. 9, are used as input(s) to the intraoperative navigation stage performable by the intraoperative surgical management system 1000.
Still referring to FIG. 10, the intraoperative surgical management system 1000 of the navigation system 200 provides a user, such as a surgeon, with a unified technique for navigating through a surgical region by utilizing preoperative data input(s) and updated intraoperative data input(s). The processor(s), such as the at least one processor 402, is operable by way of a set of instructions and/or algorithms storable in relation to a non-transitory memory device, such as the at least one memory 404, wherein the at least one processor 402 is configured to: analyze preoperative data input(s) and intraoperative data input(s) and update surgical plans during the course of surgery accordingly.
Still referring to FIG. 10, for example, if intraoperative input(s) in the form of newly acquired images identified a previously unknown or unidentified nerve bundle or a previously unknown or unidentified fiber track, the at least one processor 402 can use these intraoperative input(s), if desired, for updating the surgical plan during surgery to avoid contacting the nerve bundle. The intraoperative input(s) may include a variety of input(s), including local data gathered using a variety of sensor(s), such as at least one intraoperative imaging sensor (not shown). In some embodiments, the intraoperative surgical management system 1000 of the navigation system 200 may provide continuously updated, e.g., in real-time, intraoperative input(s) in the context of a specific surgical procedure by way of the at least one intraoperative imaging sensor to: validate tissue position, update tissue imaging after tumor resection, and update surgical device position during surgery.
Still referring to FIG. 10, the intraoperative surgical management system 1000 of the navigation system 200 may provide for re-formatting of the image, for example, to warn of possible puncture of, or collision with, critical tissue structures with a surgical tool during surgery. In addition, the intraoperative surgical management system 1000 may provide imaging and input updates for any shifts or surgical errors that might occur from a needle deflection, tissue deflection, or patient movement as well as provide analysis and transformation of data to correct for imaging distortions, e.g., in real-time. The magnitude of these combined shifts or surgical errors is clinically significant and may regularly exceed 2 cm. Some of the most significant distortions are magnetic resonance imaging (MRI) based distortions such as gradient non-linearity, susceptibility shifts, and eddy current artifacts, which may exceed 1 cm on standard MRI scanners (1.5 T and 3.0 T systems). The intraoperative surgical management system 1000 mitigates, and may eliminate, these combined shifts or surgical errors.
Still referring to FIG. 10, in accordance with some embodiments of the present disclosure, by using the intraoperative surgical management system 1000, a variety of intraoperative imaging techniques are implemented to generate intraoperative input(s) by way of a variety of imaging devices, including anatomy specific MRI devices, surface array MRI scans, endo-nasal MRI devices, anatomy specific ultrasound (US) scans, endo-nasal US scans, anatomy specific computerized tomography (CT) or positron emission tomography (PET) scans, port-based or probe based photo-acoustic imaging, sensored tool imaging and/or characterization, as well as optical imaging done with remote scanning, or probe based scanning, whereby multi-modal imaging and data are providable and transformable into useful images and data in real-time.
Referring back to FIGS. 1-4B, these diagrams, together, illustrate a surgical tool 1500, operable with an external data processing unit, e.g., the control and processing unit 1530, for use within an open surgical cavity (not shown), in accordance with an embodiment of the present disclosure. The surgical tool 1500 comprises: a medical instrument of the medical instruments 460, e.g., a rigid elongate tool body 1502 comprising a substantially rigid tool tip 1504 configured to be displaced and tracked within the open surgical cavity for reproducibly locating the substantially rigid tool tip 1504 within the open surgical cavity, the rigid elongate tool body 1502 configured to operate with at least one pressure sensor, e.g., of the pressure sensors 1518, at least one camera, e.g., of the cameras 1516, and the external data processing unit, e.g., the control and processing unit 1530; and another medical instrument of medical instruments 460, e.g., a suction tool comprising a suction tool tip portion, the suction tool configured to operate with at least one other pressure sensor, e.g., of the pressure sensors 1518, at least one other camera, e.g., of the cameras 1516, and the external data processing unit, e.g., the control and processing unit 1530, wherein imaging, locating, and mapping inner cavity characteristics are considered by the external data processing unit, e.g., the control and processing unit 1530, in real-time during a surgical procedure, the external data processing unit, e.g., the control and processing unit 1530, operable to: associate at least one pressure reading, corresponding to at least one sensor signal from the at least one pressure sensor, e.g., of the pressure sensors 1518, with at least one location of each at least one pressure sensor, e.g., of the pressure sensors 1518, within the open surgical cavity; associate at least one pressure reading, corresponding to at least one sensor signal from the at least one other pressure sensor, e.g., of the pressure sensors 1518, with at least one location of each at least one other pressure sensor, e.g., of the pressure sensors 1518, within the open surgical cavity; and associate at least one respective inner-cavity image, e.g., the images 205 a, 211 a, with at least one location of the substantially rigid tool tip 1504 and at least one location of the suction tool tip portion.
Still referring back to FIGS. 1-4B, the surgical tool 1500 further comprises the at least one camera, e.g., of the cameras 1516, the at least one camera disposed, and laterally-oriented, along the rigid elongate tool body 1502 in one of at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504 to capture at least one lateral image (not shown) from within the open surgical cavity (not shown), the at least one lateral image externally communicable to associate at least one respective inner-cavity image with the at least one location of the substantially rigid tool tip 1504, and the at least one camera, e.g., of the cameras 1516, operable in a near-infrared wavelength range.
Still referring back to FIGS. 1-4B, the surgical tool 1500 further comprises the at least one pressure sensor, e.g., of the pressure sensors 1518, the at least one pressure sensor operatively disposed along the rigid elongate tool body 1502 at a position in one of at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504, the pressure sensor responsive to pressure variations applied thereto from within the open surgical cavity to output a sensor signal representative thereof as the substantially rigid tool tip 1504 is displaced within the open surgical cavity, the sensor signal externally communicable to associate respective inner-cavity pressure readings with locations of the substantially rigid tool tip 1504. The surgical tool 1500 further comprises a set of fiducial markers, e.g., the tracking markers 1512, externally coupled in a fixed configuration to an externally extending portion of the rigid elongate tool body 1502, the markers trackable by an external tracking system, e.g., the tracking and navigation module 1536, to automatically determine the at least one location of the substantially rigid tool tip 1504, with reference to the open surgical cavity, based on a respective tracked position of the set of fiducial markers, e.g., the tracking markers 1512. The surgical tool 1500 further comprises a radio frequency transmitter to wirelessly communicate the sensor signal, e.g., via a wireless receiver/transmitter and antenna 1526.
Still referring back to FIGS. 1-4B, the pressure sensor, e.g., of the pressure sensors 1518, is laterally oriented relative to the substantially rigid tool tip 1504. In some embodiments, the pressure sensor, e.g., of the pressure sensors 1518, comprises at least one of: a Fabry-Perot pressure sensor, a piezoresistive pressure sensor, nanotube pressure sensor, and an optical microelectromechanical (MEMS) pressure sensor. In some embodiments, the pressure sensor comprises a plurality of pressure sensors disposed at a position in one of: at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504. In some embodiments, the pressure sensor comprises a plurality of pressure sensors collocated at a position in one of: at the substantially rigid tool tip and toward the substantially rigid tool tip.
Still referring back to FIGS. 1-4B, in the surgical tool 1500, at least one of: the suction tool tip portion comprises a disposable tip portion; the suction tool is disposed at a position, in one of: at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504, to concurrently provide suction within the surgical cavity around the substantially rigid tool tip 1504; at least one external camera is configured to align with, and view, the open surgical cavity, and the substantially rigid tool tip 1504 is operable as a trackable pointer within the open surgical cavity.
Still referring back to FIGS. 1-4B, the surgical tool 1500 further comprises at least one complementary camera disposed along the rigid elongate tool body 1502 at a position, in one of at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504, to capture complementary images of the open surgical cavity along a complementary imaging axis angled toward a cavity bottom relative to at least one camera, e.g., of the cameras 1516, to construct one of a 3D inner-cavity mapping and an enlarged field of view image of the open surgical cavity from the at least one lateral image and the complementary images.
Still referring back to FIGS. 1-4B, at least one of the at least one external camera and a scope is configured to align with, and view, the open surgical cavity. The at least one inner-cavity image is complementary to at least one external image captured by at least one of the at least one external camera and the scope in enhancing inner-cavity visualization. The substantially rigid tool tip 1504 is movable within the open surgical cavity to track at last one pressure variation resulting from inner-cavity bleeding in locating a bleeding site within the open surgical cavity. The rigid elongate tool body 1502 comprises a reusable tool shaft portion and a disposable tool tip portion removably operatively connectable to the shaft portion. The disposable tool tip portion comprises the substantially rigid tool tip 1504 and the pressure sensor, e.g., of the pressure sensors 1518.
Referring to FIG. 11, this flow diagram illustrates a method M1 of providing a surgical tool 1500, operable with an external data processing unit, e.g., the control and processing unit 1530, for use within an open surgical cavity (not shown), in accordance with an embodiment of the present disclosure. The method M1 comprises: providing a medical instrument of the medical instruments 460, e.g., a rigid elongate tool body 1502, comprising a substantially rigid tool tip 1504 configured to be displaced and tracked within the open surgical cavity for reproducibly locating the substantially rigid tool tip 1504 within the open surgical cavity, the rigid elongate tool body 1502 configured to operate with at least one pressure sensor, e.g., of the pressure sensors 1518, at least one camera, e.g., of the cameras 1516, and the external data processing unit, e.g., the control and processing unit 1530, as indicated by block 1101; and providing another medical instrument of medical instruments 460, e.g., a suction tool comprising a suction tool tip portion, the suction tool configured to operate with at least one other pressure sensor, e.g., of the pressure sensors 1518, at least one other camera, e.g., of the cameras 1516, and the external data processing unit, e.g., the control and processing unit 1530, as indicated by block 1102, wherein imaging, locating, and mapping inner cavity characteristics are considered by the external data processing unit, e.g., the control and processing unit 1530, in real-time during a surgical procedure, the external data processing unit, e.g., the control and processing unit 1530, operable to: associate at least one pressure reading, corresponding to at least one sensor signal from the at least one pressure sensor, e.g., of the pressure sensors 1518, with at least one location of each at least one pressure sensor, e.g., of the pressure sensors 1518, within the open surgical cavity; associate at least one pressure reading, corresponding to at least one sensor signal from the at least one other pressure sensor, e.g., of the pressure sensors 1518, with at least one location of each at least one other pressure sensor, e.g., of the pressure sensors 1518, within the open surgical cavity; and associate at least one respective inner-cavity image, e.g., the images 205 a, 211 a, with at least one location of the substantially rigid tool tip 1504 and at least one location of the suction tool tip portion.
Still referring to FIG. 11, the method M1 further comprises providing the at least one camera, e.g., of the cameras 1516, providing the at least one camera comprising disposing, and laterally-orienting, the at least one camera along the rigid elongate tool body 1502 in one of at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504 to capture at least one lateral image from within the open surgical cavity, the at least one lateral image externally communicable to associate at least one respective inner-cavity image, e.g., the images 205 a, 211 a, with the at least one location of the substantially rigid tool tip 1504, and the at least one camera operable in a near-infrared wavelength range, as indicated by block 1103.
Still referring to FIG. 11, the method M1 further comprises providing the at least one pressure sensor, e.g., of the pressure sensors 1518, providing the at least one pressure sensor comprising operatively disposing the at least one pressure sensor along the rigid elongate tool body 1502 at a position in one of at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504, the pressure sensor responsive to pressure variations applied thereto from within the open surgical cavity to output a sensor signal representative thereof as the substantially rigid tool tip 1504 is displaced within the open surgical cavity, the sensor signal externally communicable to associate respective inner-cavity pressure readings with locations of the substantially rigid tool tip 1504, as indicated by block 1104.
Still referring to FIG. 11, the method M1 further comprises providing a set of fiducial markers, e.g., the tracking markers 1512, externally coupled in a fixed configuration to an externally extending portion of the rigid elongate tool body 1502, the markers trackable by an external tracking system, e.g., the tracking and navigation module 1536, to automatically determine the at least one location of the substantially rigid tool tip 1504, with reference to the open surgical cavity, based on a respective tracked position of the set of fiducial markers, e.g., the tracking markers 1512, as indicated by block 1105. The method M1 further comprises providing a radio frequency transmitter to wirelessly communicate the sensor signal, as indicated by block 1106.
Still referring to FIG. 11, in the method M1, at least one of: providing the at least one pressure sensor, e.g., of the pressure sensors 1518, as indicated by block 1104, comprises laterally orienting the at least one pressure sensor relative to the substantially rigid tool tip; providing the at least one pressure sensor, e.g., of the pressure sensors 1518, as indicated by block 1104, comprises providing at least one of: a Fabry-Perot pressure sensor, a piezoresistive pressure sensor, nanotube pressure sensor, and an optical microelectromechanical (MEMS) pressure sensor; providing the at least one pressure sensor, e.g., of the pressure sensors 1518, as indicated by block 1104, comprises providing a plurality of pressure sensors disposed at a position in one of: at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504; providing the at least one pressure sensor, e.g., of the pressure sensors 1518, as indicated by block 1104, comprises collocating a plurality of pressure sensors 1518 at a position in one of: at the substantially rigid tool tip 1504 and toward the substantially rigid tool tip 1504; providing another medical instrument of medical instruments 460, e.g., a suction tool, as indicated by block 1102, comprises providing the suction tool tip portion as a disposable tip portion, providing another medical instrument of medical instruments 460, e.g., a suction tool, as indicated by block 1102, comprises disposed the suction tool at a position, in one of: at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504, to concurrently provide suction within the surgical cavity around the substantially rigid tool tip 1504; providing the at least one camera, e.g., of the cameras 1516, as indicated by block 1103, comprises providing at least one external camera configured to align with, and view, the open surgical cavity; and providing the medical instrument of the medical instruments 460, e.g., a rigid elongate tool body 1502, comprises providing the substantially rigid tool tip 1504 being operable as a trackable pointer within the open surgical cavity, the at least one external camera and a scope is configured to align with, and view, the open surgical cavity, the at least one inner-cavity image is complementary to at least one external image captured by at least one of the at least one external camera and the scope in enhancing inner-cavity visualization, the substantially rigid tool tip 1504 is movable within the open surgical cavity to track at last one pressure variation resulting from inner-cavity bleeding in locating a bleeding site within the open surgical cavity, the rigid elongate tool body 1502 comprises a reusable tool shaft portion and a disposable tool tip portion removably operatively connectable to the shaft portion, and the disposable tool tip portion comprises the substantially rigid tool tip 1504 and the pressure sensor 1518.
Still referring to FIG. 11, the method M1 further comprises providing at least one complementary camera, providing the at least one complementary camera comprising disposing the at least one complementary camera along the rigid elongate tool body 1502 at a position, in one of at the substantially rigid tool tip 1504 and proximate the substantially rigid tool tip 1504, to capture complementary images of the open surgical cavity along a complementary imaging axis angled toward a cavity bottom relative to at least one camera to construct one of a 3D inner-cavity mapping and an enlarged field of view image of the open surgical cavity from the at least one lateral image and the complementary images, as indicated by block 1107.
Referring to FIG. 12, this flow diagram illustrates a method M2 of imaging, locating, and mapping inner cavity characteristics within an open surgical cavity by way of a surgical tool 1500 operable with an external data processing unit, e.g., the control and processing unit 1530, in accordance with an embodiment. The method M2 comprises: providing the surgical tool 1500, as indicated by block 1200, providing the surgical tool 1500 comprising: providing a rigid elongate tool body 1502 comprising a substantially rigid tool tip 1504 configured to be displaced and tracked within the open surgical cavity for reproducibly locating the substantially rigid tool tip 1504 within the open surgical cavity, the rigid elongate tool body 1502 configured to operate with at least one pressure sensor, e.g., of the pressure sensors 1518, at least one camera, e.g., of the cameras 1516, and the external data processing unit, e.g., the control and processing unit 1530, as indicated by block 1201; and providing another medical instrument of medical instruments 460, e.g., a suction tool comprising a suction tool tip portion, the suction tool configured to operate with at least one other pressure sensor, e.g., of the pressure sensors 1518, at least one other camera, e.g., of the cameras 1516, and the external data processing unit, e.g., the control and processing unit 1530, as indicated by block 1202; and considering imaging, locating, and mapping inner cavity characteristics in real-time during a surgical procedure by the external data processing unit, e.g., the control and processing unit 1530, as indicated by block 1203, considering comprising: associating at least one pressure reading, corresponding to at least one sensor signal from the at least one pressure sensor, e.g., of the pressure sensors 1518, with at least one location of each at least one pressure sensor, e.g., of the pressure sensors 1518, within the open surgical cavity, as indicated by block 1204; associating at least one pressure reading, corresponding to at least one sensor signal from the at least one other pressure sensor, e.g., of the pressure sensors 1518, with at least one location of each at least one other pressure sensor, e.g., of the pressure sensors 1518, within the open surgical cavity, as indicated by block 1205; and associating at least one respective inner-cavity image, e.g., the images 205 a, 211 a, with at least one location of the substantially rigid tool tip 1504 and at least one location of the suction tool tip portion, as indicated by block 1206.
Thus, the present disclosure is not limited to a specific configuration of hardware, firmware, and/or software. While some embodiments can be implemented in fully functioning computers and computer systems, various embodiments are capable of being distributed as a computing product in a variety of forms and are capable of being applied regardless of the particular type of machine or computer readable media used to actually effect the distribution. At least some aspects disclosed can be embodied, at least in part, in software. That is, the techniques may be carried out in a computer system or other data processing system in response to its processor, such as a microprocessor, executing sequences of instructions contained in a memory, such as ROM, volatile RAM, non-volatile memory, cache or a remote storage device. A computer readable storage medium can be used to store software and data which when executed by a data processing system causes the system to perform various methods. The executable software and data may be stored in various places including for example ROM, volatile RAM, nonvolatile memory and/or cache. Portions of this software and/or data may be stored in any one of these storage devices.
The preceding exemplary embodiments involve systems and methods in which a device is intra-operatively configured based on the identification of a medical instrument. In other example embodiments, one or more devices may be automatically controlled and/or configured by determining one or more context measures associated with a medical procedure. A “context measure”, as used herein, refers to an identifier, data element, parameter or other form of information that pertains to the current state of a medical procedure. In one example, a context measure may describe, identify, or be associated with, the current phase or step of the medical procedure. In another example, a context measure may identity the medical procedure, or the type of medical procedure, that is being performed. In another example, a context measure may identify the presence of a tissue type during a medical procedure. In another example, a context measure may identify the presence of one or more fluids, such as biological fluids or non-biological fluids, e.g., wash fluids, during the medical procedure, and may further identify the type of fluid. Each of these examples relate to the image-based identification of information pertaining to the context of the medical procedure.
Examples of computer-readable storage media include, but are not limited to, recordable and non-recordable type media such as volatile and non-volatile memory devices, ROM, RAM, flash memory devices, floppy and other removable disks, magnetic disk storage media, optical storage media, e.g., compact discs (CDs), digital versatile disks (DVDs), etc., among others. The instructions can be embodied in digital and analog communication links for electrical, optical, acoustical or other forms of propagated signals, such as carrier waves, infrared signals, digital signals, and the like. The storage medium may be the internet cloud, or a computer readable storage medium such as a disc.
At least some of the methods described herein are capable of being distributed in a computer program product comprising a computer readable medium that bears computer usable instructions for execution by one or more processors, to perform aspects of the methods described. The medium may be provided in various forms such as, but not limited to, one or more diskettes, compact disks, tapes, chips, USB keys, external hard drives, wire-line transmissions, satellite transmissions, internet transmissions or downloads, magnetic and electronic storage media, digital and analog signals, and the like. The computer usable instructions may also be in various forms, including compiled and non-compiled code.
While the present disclosure describes various embodiments for illustrative purposes, such description is not intended to be limited to such embodiments. On the contrary, the applicant's teachings described and illustrated herein encompass various alternatives, modifications, and equivalents, without departing from the embodiments, the general scope of which is defined in the appended claims. Except to the extent necessary or inherent in the processes themselves, no particular order to steps or stages of methods or processes described in this disclosure is intended or implied. In many cases the order of process steps may be varied without changing the purpose, effect, or import of the methods described.
Information as herein shown and described in detail is fully capable of attaining the above-described object of the present disclosure, the presently preferred embodiment of the present disclosure, and is, thus, representative of the subject matter which is broadly contemplated by the present disclosure. The scope of the present disclosure fully encompasses other embodiments which may become apparent to those skilled in the art, and is to be limited, accordingly, by nothing other than the appended claims, wherein any reference to an element being made in the singular is not intended to mean “one and only one” unless explicitly so stated, but rather “one or more.” All structural and functional equivalents to the elements of the above-described preferred embodiment and additional embodiments are hereby expressly incorporated by reference and are intended to be encompassed by the present claims.
Moreover, no requirement exists for a system or method to address each and every problem sought to be resolved by the present disclosure, for such to be encompassed by the present claims. Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public, regardless of whether the element, component, or method step is explicitly recited in the claims. However, that various changes and modifications in form, material, work-piece, and fabrication material detail may be made, without departing from the spirit and scope of the present disclosure, as set forth in the appended claims, are also encompassed by the disclosure.

Claims

What is claimed:

1. A surgical tool, operable with an external data processing unit, for use within an open surgical cavity, the surgical tool comprising:

a rigid elongate tool body comprising a substantially rigid tool tip configured to be displaced and tracked within the open surgical cavity for reproducibly locating the substantially rigid tool tip within the open surgical cavity, the rigid elongate tool body configured to operate with at least one pressure sensor, at least one camera, and the external data processing unit; and

a suction tool comprising a suction tool tip portion, the suction tool configured to operate with at least one other pressure sensor, at least one other camera, and the external data processing unit,

wherein imaging, locating, and mapping inner cavity characteristics are considered by the external data processing unit in real-time during a surgical procedure, the external data processing unit operable to:

associate at least one pressure reading, corresponding to at least one sensor signal from the at least one pressure sensor, with at least one location of each at least one pressure sensor within the open surgical cavity;

associate at least one pressure reading, corresponding to at least one sensor signal from the at least one other pressure sensor, with at least one location of each at least one other pressure sensor within the open surgical cavity; and

associate at least one respective inner-cavity image with at least one location of the substantially rigid tool tip and at least one location of the suction tool tip portion.

2. The surgical tool of claim 1, further comprising the at least one camera, the at least one camera disposed, and laterally-oriented, along the rigid elongate tool body in one of at the substantially rigid tool tip and proximate the substantially rigid tool tip to capture at least one lateral image from within the open surgical cavity, the at least one lateral image externally communicable to associate at least one respective inner-cavity image with the at least one location of the substantially rigid tool tip, and the at least one camera operable in a near-infrared wavelength range.

3. The surgical tool of claim 1, further comprising the at least one pressure sensor, the at least one pressure sensor operatively disposed along the rigid elongate tool body at a position in one of at the substantially rigid tool tip and proximate the substantially rigid tool tip, the pressure sensor responsive to pressure variations applied thereto from within the open surgical cavity to output a sensor signal representative thereof as the substantially rigid tool tip is displaced within the open surgical cavity, the sensor signal externally communicable to associate respective inner-cavity pressure readings with locations of the substantially rigid tool tip.

4. The surgical tool of claim 1, further comprising a set of fiducial markers externally coupled in a fixed configuration to an externally extending portion of the rigid elongate tool body, the markers trackable by an external tracking system to automatically determine the at least one location of the substantially rigid tool tip, with reference to the open surgical cavity, based on a respective tracked position of the set of fiducial markers.

5. The surgical tool of claim 1, further comprising a radio frequency transmitter to wirelessly communicate the sensor signal.

6. The surgical tool of claim 3, wherein at least one of:

the pressure sensor is laterally oriented relative to the substantially rigid tool tip,

the pressure sensor comprises at least one of: a Fabry-Perot pressure sensor, a piezoresistive pressure sensor, nanotube pressure sensor, and an optical microelectromechanical (MEMS) pressure sensor,

the pressure sensor comprises a plurality of pressure sensors disposed at a position in one of: at the substantially rigid tool tip and proximate the substantially rigid tool tip, and

the pressure sensor comprises a plurality of pressure sensors collocated at a position in one of: at the substantially rigid tool tip and toward the substantially rigid tool tip.

7. The surgical tool of claim 1, wherein at least one of:

the suction tool tip portion comprises a disposable tip portion, and

the suction tool is disposed at a position, in one of: at the substantially rigid tool tip and proximate the substantially rigid tool tip, to concurrently provide suction within the surgical cavity around the substantially rigid tool tip.

8. The surgical tool of claim 1, wherein at least one of:

at least one external camera is configured to align with, and view, the open surgical cavity, and

the substantially rigid tool tip is operable as a trackable pointer within the open surgical cavity.

9. The surgical tool of claim 2, further comprising at least one complementary camera disposed along the rigid elongate tool body at a position, in one of at the substantially rigid tool tip-and proximate the substantially rigid tool tip, to capture complementary images of the open surgical cavity along a complementary imaging axis angled toward a cavity bottom relative to at least one camera to construct one of a 3D inner-cavity mapping and an enlarged field of view image of the open surgical cavity from the at least one lateral image and the complementary images.

10. The surgical tool of claim 8,

wherein at least one of the at least one external camera and a scope is configured to align with, and view, the open surgical cavity, and

wherein the at least one inner-cavity image is complementary to at least one external image captured by at least one of the at least one external camera and the scope in enhancing inner-cavity visualization.

11. The surgical tool of claim 1, wherein the substantially rigid tool tip is movable within the open surgical cavity to track at last one pressure variation resulting from inner-cavity bleeding in locating a bleeding site within the open surgical cavity.

12. The surgical tool of claim 1,

wherein the rigid elongate tool body comprises a reusable tool shaft portion and a disposable tool tip portion removably operatively connectable to the shaft portion, and

wherein the disposable tool tip portion comprises the substantially rigid tool tip and the pressure sensor.

13. A method of providing a surgical tool, operable with an external data processing unit, for use within an open surgical cavity, the method comprising:

providing a rigid elongate tool body comprising a substantially rigid tool tip configured to be displaced and tracked within the open surgical cavity for reproducibly locating the substantially rigid tool tip within the open surgical cavity, the rigid elongate tool body configured to operate with at least one pressure sensor, at least one camera, and the external data processing unit; and

providing a suction tool comprising a suction tool tip portion, the suction tool configured to operate with at least one other pressure sensor, at least one other camera, and the external data processing unit,

14. The method of claim 13, further comprising providing the at least one camera, providing the at least one camera comprising disposing, and laterally-orienting, the at least one camera along the rigid elongate tool body in one of at the substantially rigid tool tip and proximate the substantially rigid tool tip to capture at least one lateral image from within the open surgical cavity, the at least one lateral image externally communicable to associate at least one respective inner-cavity image with the at least one location of the substantially rigid tool tip, and the at least one camera operable in a near-infrared wavelength range.

15. The method of claim 13, further comprising providing the at least one pressure sensor, providing the at least one pressure sensor comprising operatively disposing the at least one pressure sensor along the rigid elongate tool body at a position in one of at the substantially rigid tool tip and proximate the substantially rigid tool tip, the pressure sensor responsive to pressure variations applied thereto from within the open surgical cavity to output a sensor signal representative thereof as the substantially rigid tool tip is displaced within the open surgical cavity, the sensor signal externally communicable to associate respective inner-cavity pressure readings with locations of the substantially rigid tool tip.

16. The method of claim 13, further comprising a set of fiducial markers externally coupled in a fixed configuration to an externally extending portion of the rigid elongate tool body, the markers trackable by an external tracking system to automatically determine the at least one location of the substantially rigid tool tip, with reference to the open surgical cavity, based on a respective tracked position of the set of fiducial markers.

17. The method of claim 13, further comprising a radio frequency transmitter to wirelessly communicate the sensor signal.

18. The method of claim 15, wherein:

the pressure sensor comprises a plurality of pressure sensors disposed at a position in one of: at the substantially rigid tool tip and proximate the substantially rigid tool tip,

the pressure sensor comprises a plurality of pressure sensors collocated at a position in one of: at the substantially rigid tool tip and toward the substantially rigid tool tip,

the suction tool tip portion comprises a disposable tip portion,

the suction tool is disposed at a position, in one of: at the substantially rigid tool tip and proximate the substantially rigid tool tip, to concurrently provide suction within the surgical cavity around the substantially rigid tool tip,

the substantially rigid tool tip is operable as a trackable pointer within the open surgical cavity

the at least one external camera and a scope is configured to align with, and view, the open surgical cavity,

the at least one inner-cavity image is complementary to at least one external image captured by at least one of the at least one external camera and the scope in enhancing inner-cavity visualization,

the substantially rigid tool tip is movable within the open surgical cavity to track at last one pressure variation resulting from inner-cavity bleeding in locating a bleeding site within the open surgical cavity,

the rigid elongate tool body comprises a reusable tool shaft portion and a disposable tool tip portion removably operatively connectable to the shaft portion, and

the disposable tool tip portion comprises the substantially rigid tool tip and the pressure sensor.

19. The method of claim 13, further comprising providing at least one complementary camera, providing the at least one complementary camera comprising disposing the at least one complementary camera along the rigid elongate tool body at a position, in one of at the substantially rigid tool tip and proximate the substantially rigid tool tip, to capture complementary images of the open surgical cavity along a complementary imaging axis angled toward a cavity bottom relative to at least one camera to construct one of a 3D inner-cavity mapping and an enlarged field of view image of the open surgical cavity from the at least one lateral image and the complementary images.

20. A method of imaging, locating, and mapping inner cavity characteristics within an open surgical cavity by way of a surgical tool operable with an external data processing unit, the method comprising:

providing the surgical tool, providing the surgical tool comprising:

providing a suction tool comprising a suction tool tip portion, the suction tool configured to operate with at least one other pressure sensor, at least one other camera, and the external data processing unit; and

considering imaging, locating, and mapping inner cavity characteristics in real-time during a surgical procedure by the external data processing unit, considering comprising:

associating at least one pressure reading, corresponding to at least one sensor signal from the at least one pressure sensor, with at least one location of each at least one pressure sensor within the open surgical cavity;

associating at least one pressure reading, corresponding to at least one sensor signal from the at least one other pressure sensor, with at least one location of each at least one other pressure sensor within the open surgical cavity; and

associating at least one respective inner-cavity image with at least one location of the substantially rigid tool tip and at least one location of the suction tool tip portion.