The present disclosure generally relates to introducers for minimally invasive surgeries. The present disclosure specifically relates to an image guidance of steerable introducers into anatomical regions.
Introducers are used to provide an intervention instrument channel for minimally invasive “key-hole” surgery. An example of such introducers are neuro-introducers for endoscopic neurosurgery (e.g., ventriculetomy, tumor resection, shunt procedures) or trocars for surgery (e.g., cardiac, abdominal, lung, ENT).
Some of these introducers include a printed scale on a straight introducer sheath that is used to gauge a depth of instrument introduction into an anatomical region to thereby provide safe access of the anatomical region. For example, stereotactic frames or frameless navigation are implemented to assist a surgeon in controlling an insertion point and angle of insertion of the neuro-introducer at a desired depth.
One issue with introducers is straight introducer sheaths do not provide sufficient dexterity for obstacle avoidance. Additionally, the placement of the straight introducer sheaths is usually blind and not guided by live images of the anatomical region, which further decreases safety and increases risk of injury to important anatomical structures within the region.
The present disclosure provides inventions utilizing an image guidance based placement control of numerous and various types of minimally invasive procedures incorporating a steerable introducer for providing an interventional instrument tunnel into an anatomical region (e.g., a thoracic region, a cranial region, an abdominal region, a dorsal region or a lumbar region).
One form of the inventions of the present disclosure is a system employing an articulated steerable introducer, an imaging controller and a steerable introducer controller. The articulated steerable introducer includes a plurality of linkages and one or more joints interconnecting the linkages. The imaging controller controls a planning of a distal steering motion of the articulated steerable introducer to a target position within an anatomical region. The steerable introducer controller controls an actuation of the joint(s) to distally steer the articulated steerable introducer to the target position within the anatomical region as planned by the imaging controller.
A second form of the inventions of the present disclosure is a method for placing an articulated steerable introducer within an anatomical region, the articulated steerable introducer including a plurality of linkages and one or more joints interconnecting the linkages. The method involves an imaging controller controlling a planning of a distal steering motion of an articulated steerable introducer to a target position within the anatomical region. The method further involves a steerable introducer controller controlling an actuation of the joint(s) to distally steer the articulated steerable introducer to the target position within the anatomical region as planned by the imaging controller.
For purposes of the inventions of the present disclosure, terms of the art including, but not limited to, “introducer”, “image registration”, “imaging modality”, “planning image”, “treatment image”, “stereotactic frame”, “fiducial markers”, “interventional instrument”, “path planner”, “image register”, “signal driver” and “visual servo” are to be interpreted as understood in the art of the present disclosure and as exemplary described herein.
For purposes of the inventions of the term “planned introducer path” broadly encompasses, as understood in the art of the present disclosure and exemplary described herein, a straight line segment for inserting an articulated steerable introducer to a placement position within an anatomical region, and a steering motion segment for distally steering articulated steerable introducer from a placement positon to a target position within anatomical region.
For purposes of the inventions of the present disclosure, the term “articulated steerable introducer” broadly encompasses any introducer structurally configured, entirely or partially, with motorized control of one or more joints (e.g., a pivot joint) serially connected with rigid linkages including a proximal linkage, a distal linkage and optionally one or more intermediate linkages.
For purposes of the present disclosure, the term “controller” broadly encompasses all structural configurations of an application specific main board or an application specific integrated circuit housed within or linked to a workstation for controlling an application of various inventive principles of the present disclosure as subsequently described herein. The structural configuration of the controller may include, but is not limited to, processor(s), computer-usable/computer readable storage medium(s), an operating system, application module(s), peripheral device controller(s), slot(s) and port(s).
For purposes of the present disclosure, the labels “introducer”, “planning imaging”, and “treatment imaging” used herein for the term “controller” distinguishes for identification purposes a particular controller from other controllers as described and claimed herein without specifying or implying any additional limitation to the term “controller”.
For purposes of the inventions of the present disclosure, the term “workstation” is to be broadly interpreted as understood in the art of the present disclosure and as exemplary described herein. Examples of a “workstation” include, but are not limited to, an assembly of one or more computing devices, a display/monitor, and one or more input devices (e.g., a keyboard, joysticks and mouse) in the form of a standalone computing system, a client computer, a desktop or a tablet.
For purposes of the present disclosure, the term “application module” broadly encompasses a module incorporated within or accessible by a controller consisting of an electronic circuit and/or an executable program (e.g., executable software stored on non-transitory computer readable medium(s) and/firmware) for executing a specific application.
The foregoing forms and other forms of the present disclosure as well as various features and advantages of the present disclosure will become further apparent from the following detailed description of various embodiments of the present disclosure read in conjunction with the accompanying drawings. The detailed description and drawings are merely illustrative of the present disclosure rather than limiting, the scope of the present disclosure being defined by the appended claims and equivalents thereof.
To facilitate an understanding of the present disclosure, the following description of
Referring to
Still referring to
For all embodiments, one or more treatment images 21b are registered to planning image 21a as known in the art.
In a stereotactic frame registration embodiment, a registration of a stereotactic frame 30 to planning image 21a as known in the art involves a generation of the treatment image 21b illustrative of stereotactic frame 30 affixed to a head and/or a neck of patient 10, or alternatively illustrative of a marker placement of a subsequent affixation of stereotactic frame 30 to the head and/or the neck of patient 10. The registration of stereotactic frame 30 to planning image 21a is accomplished by one of the controllers 22a and 22b in accordance with the following equation [1]:
DI
T
SF=TITSF*PITTI [1]
where TITSF is the transformation of stereotactic frame 30 to treatment image 21b,
where PITH is the transformation of treatment image 21b to planning image 21a, and
where PITSF is the transformation of stereotactic frame 30 to planning image 21a.
In a frameless stereotactic registration embodiment, a registration of a fiducial markers 31 to planning image 21a as known in the art involves a generation of a treatment image 21b illustrative of fiducial markers 31 affixed to a head of patient 10. The registration of fiducial markers 31 to planning image 21a is accomplished by one of the controllers 22a and 22b in accordance with the following equation [2]:
DI
T
FM=TITFM*PITTI [2]
where TITFM is the transformation of fiducial markers 31 to treatment image 21b,
where PITH is the transformation of treatment image 21b to planning image 21a, and
where PITFM is the transformation of fiducial markers 31 to planning image 21a.
Still referring to
In a treatment image insertion embodiment, a surgeon inserts introducer 40 into the entry point while viewing a treatment image 21b illustrative of an insertion of introducer 40 through the entry point into the cranial region of patient 10 and/or viewing an overlay of introducer 40 on the registered planning image 21a as introducer 40 is inserted through the entry point into brain 11 of patient 10.
In a stereotactic frame insertion embodiment, stereotactic frame 30 is affixed to the head and/or the neck of patient 10 as registered to planning image 21a, and adjusted to 3D coordinates of the entry point as illustrated in planning image 21a. The surgeon inserts introducer 40 via stereotactic frame 30 through the entry point into brain 11 of patient 10 as known in the art.
In a frameless stereotactic insertion embodiment, fiducial markers 31 are affixed to the head of patient 10 as registered to planning image 21a, and utilized to compute the 3D coordinates of the entry point as illustrated in planning image 21a. The surgeon inserts introducer 40 via stereotactic frame 30 through the computed entry point into brain 11 of patient 10 as known in the art.
Still referring to
In a treatment image steering embodiment, a steerable introducer controller 41 executes a visual servo control of the distal steering of introducer 40 along the pitch segment and/or the yaw segment of the registered planning image 21a to the target position within brain 11 of patient 10 as will be further described herein.
In a stereotactic frame/frameless stereotactic steering embodiments, steerable introducer controller 41 executes an autonomous driving control of the distal steering of introducer 40 along the pitch segment and/or the yaw segment of the registered planning image 21a to the target position within brain 11 of patient 10 as will be further described herein.
Still referring to
In practice, planning imaging modality 20a and treatment imaging modality 20b may or may not be the same type of imaging modality, or may be the same imaging modality
Also in practice, treatment imaging modality 20b may be operated to image the stereotactic frame/frameless stereotactic insertion and distal steering of the minimally invasive transcranial endoscopic neurosurgery.
Further in practice, the controllers of
For example,
Also by example,
By further example,
To facilitate a further understanding of the present disclosure, the following description of
Generally, an articulated steerable introducer of the present disclosure employs a proximal linkage, a distal linkage and optionally one or more intermediate linkages. The articulated steerable introducer further includes joint(s) interconnecting the linkages in a complete or partial serial arrangement, and each pivot joint is controllable by a steerable introducer controller of the present disclosure.
In practice, a joint may be of any type of joint as known in the art including, but not limited to, a translational joint, a ball and socket joint, a hinge joint, a condyloid joint, a saddle joint and a rotary joint.
Also in practice, each pivot joint may be equipped with a motor for controlling a pose of each linkage, and/or a position sensor of any type (e.g., an encoder) for generating pose data informative of a pose (i.e., orientation and/or location) of the distal linkage relative to the proximal linkage.
For example, referring to
Motorized pivot joint 42a is equipped with a rotary encoder (not shown) to generate an encoded pitch signal ESP informative of a pitch orientation of distal link 41d within pitch envelope 43p relative to proximal linkage 41p.
By further example, referring to
Motorized pivot joint 42b is equipped with a rotary encoder (not shown) to generate an encoded pitch signal ESY informative of a yaw orientation of intermediate linkage 41i and distal linkage 41d within yaw envelope 47Y relative to proximal linkage 41p.
Referring to
Motorized pivot joint 42c is equipped with a rotary encoder (not shown) to generate an encoded pitch signal ESP informative of a pitch orientation of distal link 41d within pitch envelope 43p relative to intermediate linkage 41i.
In practice, motorized pivot joints 42b and 42c may be adjacent or spaced as exemplary shown in
Also in practice, a translational joint may interconnect proximal linkage 41p and intermediate linkage 41i to thereby translate intermediate linkage 41i and distal linkage 41d during an insertion of introducer 40b into an anatomical region.
Further in practice, the linkages of an articulated steerable introducer of the present disclosure may be structurally designed with one or more internal and/or external channels for interventional instruments.
For example,
By further example,
To facilitate a further understanding of the present disclosure, the following description of
Referring to
Specifically, stage S72 of flowchart 70 encompasses (1) a planning scan of the patient, (2) a delineation of traversable area(s) by an introducer of the present disclosure an anatomical structure within the anatomical region to a target position, (3) a computation of all possible introducer path(s) through the traversable area(s) to the target position, and (4) a selection of a planned introducer path through a traversable area to the target position.
Each introducer path includes a straight line segment for inserting an introducer of the present disclosure to a placement position within the anatomical region. Each introducer path further includes a pitch segment and/or a yaw segment for distally steering an introducer of the present disclosure into the anatomical region to a target position within the anatomical region.
For example,
Thereafter, a surgeon interfaces with path planner 80 to delineate the traversable areas, such as, for example, a traversable area 83a and a traversable area 83b through by working model 81 of brain 11 to a target position represented by a gray star as shown in
In practice, traversable areas will overlap around the target position as exemplary shown in
The surgeon further interfaces with path planner 80 to compute all possible introducer path(s) through the traversable area(s) to the target position, such as, for example, an introducer path 84a through traversable area 83a to the target position and an introducer path 84b through traversable area 83b to the target position as shown in
The surgeon further interfaces with path planner 80 to select one of the computed introducer paths based on various factors relevant to the particular procedure including, but not limited to, an optimization to minimize distance between the introducer and sensitive structures, and an optimization to minimize the steering motion of the introducer.
In practice, path planner 80 may implement any virtual planning technique(s) known in the art that is suitable for the particular type of minimally invasive procedure being performed.
Also in practice, path planner 80 may be an application module of planning imaging controller 22a and/or treatment imaging controller 22b.
Referring back to
For example, an image register 90 as shown in
The image registration(s) facilitates the identification on the patient of the entry point into the anatomical region as known in the art.
In practice, image register 90 may be implement any known transformation technique(s) as known in the art suitable for the particular type of minimally invasive procedure being performed.
Also in practice, image register 90 may be an application module of planning imaging controller 22a and/or treatment imaging controller 22b.
Referring back to
For example, as shown in
In practice, signal driver 100 is an application module of steerable introducer controller 41.
Also by example, as shown in
In practice, visual servo 110 is an application module of steerable introducer controller 41.
Referring back to
Referring to
Furthermore, as one having ordinary skill in the art will appreciate in view of the teachings provided herein, features, elements, components, etc. described in the present disclosure/specification and/or depicted in the drawings may be implemented in various combinations of electronic components/circuitry, hardware, executable software and executable firmware and provide functions which may be combined in a single element or multiple elements. For example, the functions of the various features, elements, components, etc. shown/illustrated/depicted in the drawings can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared and/or multiplexed. Moreover, explicit use of the term “processor” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor (“DSP”) hardware, memory (e.g., read only memory (“ROM”) for storing software, random access memory (“RAM”), non-volatile storage, etc.) and virtually any means and/or machine (including hardware, software, firmware, circuitry, combinations thereof, etc.) which is capable of (and/or configurable) to perform and/or control a process.
Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (e.g., any elements developed that can perform the same or substantially similar function, regardless of structure). Thus, for example, it will be appreciated by one having ordinary skill in the art in view of the teachings provided herein that any block diagrams presented herein can represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, one having ordinary skill in the art should appreciate in view of the teachings provided herein that any flow charts, flow diagrams and the like can represent various processes which can be substantially represented in computer readable storage media and so executed by a computer, processor or other device with processing capabilities, whether or not such computer or processor is explicitly shown.
Furthermore, exemplary embodiments of the present disclosure can take the form of a computer program product or application module accessible from a computer-usable and/or computer-readable storage medium providing program code and/or instructions for use by or in connection with, e.g., a computer or any instruction execution system. In accordance with the present disclosure, a computer-usable or computer readable storage medium can be any apparatus that can, e.g., include, store, communicate, propagate or transport the program for use by or in connection with the instruction execution system, apparatus or device. Such exemplary medium can be, e.g., an electronic, magnetic, optical, electromagnetic, infrared or semiconductor system (or apparatus or device) or a propagation medium. Examples of a computer-readable medium include, e.g., a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), flash (drive), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk-read only memory (CD-ROM), compact disk-read/write (CD-R/W) and DVD. Further, it should be understood that any new computer-readable medium which may hereafter be developed should also be considered as computer-readable medium as may be used or referred to in accordance with exemplary embodiments of the present disclosure and disclosure.
Having described preferred and exemplary embodiments of novel and inventive steerable introducers for minimally invasive procedures (which embodiments are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons having ordinary skill in the art in light of the teachings provided herein, including the drawings. It is therefore to be understood that changes can be made in/to the preferred and exemplary embodiments of the present disclosure which are within the scope of the embodiments disclosed herein.
Moreover, it is contemplated that corresponding and/or related systems incorporating and/or implementing the device or such as may be used/implemented in a device in accordance with the present disclosure are also contemplated and considered to be within the scope of the present disclosure. Further, corresponding and/or related method for manufacturing and/or using a device and/or system in accordance with the present disclosure are also contemplated and considered to be within the scope of the present disclosure.
Filing Document | Filing Date | Country | Kind |
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PCT/EP2017/065124 | 6/20/2017 | WO | 00 |
Number | Date | Country | |
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62353311 | Jun 2016 | US |