Plan-specific instrument templates for percutaneous interventional procedures

Abstract

A plan-specific instrument template system employs an interventional guide base (20) and an instrument guide design controller (60), the instrument guide design controller being used to control the design of a plan-specific instrument template (40), the plan-specific instrument template comprising one or more planned instrument guides for guiding one or more interventional instruments during a percutaneous intervention. In operation, the controller (60) generates and positions a general instrument template (30) relative to an image segmentation of the interventional guide base (20). A geometric representation of the plan-specific instrument template (40) of one or each general instrument guide of the instrument, the one or each instrument guide of the general instrument template (30) having a general position and a general orientation relative to a general configuration of a platform of the general instrument template (30). The controller (60) also controls at least one of repositioning, reorienting and / or reconfiguring of the general instrument guide of the general instrument template (30) relative to the platform of the general instrument template (30) to the plan-specific instrument template (40) according to a treatment plan associated with the percutaneous intervention.

Description

Technical Field

[0001] The present disclosure generally relates to accurate positioning of instruments via instrument guides during percutaneous interventional procedures. The present disclosure particularly relates to the formation and generation of plan-specific instrument templates for percutaneous interventional procedures. Background Art

[0002] Percutaneous interventional procedures involve positioning multiple elongated instruments (e.g., needles or electrodes) within the patient according to the treatment plan. Examples of such percutaneous interventional procedures include, but are not limited to, transperineal prostate brachytherapy or biopsy, lumbar spine radiofrequency or microwave ablation, facet joint injections, and irreversible electroporation using multiple electrodes.

[0003] Most percutaneous interventional procedures are very challenging because such long and thin instruments need to be positioned with a particular accuracy according to the treatment plan. More specifically, the main challenges of percutaneous interventional procedures are related to long procedure times, excessive use of contrast media and imaging radiation (e.g., X-rays), and difficulties in integrating and reproducing very complex multi-instrument treatment plans into intraoperative clinical situations.

[0004] One solution for accurately positioning elongated instruments according to a treatment plan during a percutaneous interventional procedure is the use of a stereotactic interventional navigation system. Generally, the availability of a preoperative treatment plan and its alignment with the current surgical site are great advantages of stereotactic interventional navigation systems, and several clinical sites have successfully introduced stereotactic interventional navigation systems for complex multi-needle procedures into their every day practice. However, these stereotactic interventional navigation systems are typically cumbersome to use and require significant changes to existing clinical workflows, especially due to their strong reliance on general anesthesia. More specifically, stereotactic interventional navigation systems for multi-instrument percutaneous needle interventions are difficult to set up and integrate into existing clinical workflows, especially when the use of general anesthesia is imposed, and are expensive due to the expensive tracking technology incorporated into the system.

[0005] Another solution for accurately positioning the elongated instrument according to the treatment plan during the percutaneous intervention process is the use of a general rigid template with multiple through guide holes. In general, the general rigid template has been successfully deployed in the percutaneous intervention process (e.g., perineal prostate intervention, including short-distance radiotherapy, biopsy and electroporation). Although the general rigid template is considered to be less expensive than the stereotactic intervention navigation system but is sufficiently robust for the percutaneous intervention process, there are several major limitations of the general rigid needle template for the percutaneous intervention process. One such limitation is the large and bulky design of the rigid template due to its general nature (the rigid template needs to cover a relatively large surgical access area and provide sufficient flexibility in the selection of the needle entry point). Another limitation is the specificity of the general rigid template to (one or more) specific applications (e.g., the general rigid template is specifically designed for perineal prostate intervention), whereby such templates have guide holes of a certain diameter, non-configurable needle orientation angles and uniform but non-configurable spacing between holes. The result is that the non-configurable spacing in the template forces an undesirable needle entry point. Yet another limitation is the inflexibility of the general rigid template in terms of workflow, since the general rigid template needs to be deployed prior to image acquisition, and the planning of the instrument trajectory is constrained by the evenly spaced through-holes on the general rigid template.

[0006] U.S. patent application No. US2017 / 0020623A1, entitled “Systems, Methods and Devices For Assisting Or Performing Guided Interventional Procedures Using Custom Templates” by Glossop et al. (hereinafter “the Glossop Patent Application”) addresses the challenges of stereotactic interventional navigation systems and rigid templates in general by providing a method for utilizing preoperative scans of a patient's anatomy to identify targets and critical structures as a basis for generating a virtual template comprising one or more guide elements and manufacturing a physical template as a replica of the virtual template. Summary of the invention

[0007] The invention disclosed herein addresses the challenges of stereotactic interventional navigation systems and general rigid templates and improves upon the Glossop patent application by providing a plan-specific instrument template for percutaneous interventions involving multiple elongated interventional instruments (e.g., needles or electrodes). The plan-specific instrument template disclosed herein is designed based on preoperative or intraoperative imaging of a guide base fixed relative to the patient to support the development of a treatment plan for the patient and can be generated preoperatively or intraoperatively using an additive manufacturing process or a subtractive manufacturing process.

[0008] One embodiment of aspects of the present disclosure is a plan-specific instrument template system that employs an interventional guide base and an instrument guide design controller for controlling the design of a plan-specific instrument template, the plan-specific instrument template comprising a platform and one or more planned instrument guides extending through the platform for guiding one or more interventional instruments during percutaneous intervention.

[0009] In operation, the controller generates and positions a general instrument template relative to image segmentation of the interventional guide base, the general instrument template comprising one or more general instrument guides, and the one or each general tube guide of the general instrument template having a general position and a general orientation relative to a general configuration of the platform of the general instrument template.

[0010] The controller also controls the repositioning, reorientation and / or reconfiguration of the one or each general instrument guide of the general instrument template relative to the guide surface of the general instrument template in accordance with a treatment plan associated with the percutaneous intervention, thereby forming the general instrument template into a geometric representation of the plan-specific instrument template.

[0011] A second embodiment of aspects of the present disclosure is an instrument guide design controller for controlling the design of a plan-specific instrument template, wherein the plan-specific instrument template includes a platform and one or more planned instrument guides, wherein the one or more planned instrument guides extend through the platform for guiding one or more interventional instruments during a percutaneous intervention.

[0012] The instrument guide design controller adopts a general instrument template generator, which is configured to generate and position the general instrument template relative to the image segmentation of the interventional guide base, the general instrument template includes one or more general instrument guides, and the one general instrument guide or each general instrument guide of the general instrument template has a general position and general orientation relative to the general configuration of the platform of the general instrument template.

[0013] The instrument guide design controller also employs a plan-specific instrument template designer, which is configured to control the repositioning, reorientation and / or reconfiguration of the one or each general instrument guide of the general instrument template relative to the platform of the general instrument template according to the treatment plan associated with the percutaneous intervention, thereby forming the general instrument template into a geometric representation of the plan-specific instrument template.

[0014] A third embodiment of aspects of the present disclosure is an instrument guide design method for designing a plan-specific instrument template, wherein the plan-specific instrument template includes a platform and one or more planned instrument guides, wherein the one or more planned instrument guides extend through the platform for guiding one or more interventional instruments during percutaneous intervention.

[0015] The instrument guide design method includes the instrument guide design controller generating and positioning the general instrument template relative to the image segmentation of the interventional guide base, the general instrument template including one or more general instrument guides, and the one general instrument guide or each general instrument guide of the general instrument template having a general position and a general orientation relative to the general configuration of the platform of the general instrument template.

[0016] The instrument guide design method also includes the instrument guide design controller controlling at least one of the repositioning, the reorientation and / or the reconfiguration of the one or each general instrument guide of the general instrument template relative to the platform of the general instrument template according to a treatment plan associated with the percutaneous intervention, thereby forming the general instrument template into a geometric representation of the plan-specific instrument template.

[0017] For the purposes of describing and claiming the disclosed invention:

[0018] (1) Terms in the art including but not limited to "percutaneous intervention", "interventional instrument", "image segmentation", "computer mesh" and "elastic deformation" should be interpreted as known in the field of the present disclosure and as exemplarily described in the present disclosure;

[0019] (2) Examples of interventional instruments suitable for treatment include, but are not limited to, radiofrequency instruments, microwave or electroporation electrodes, facet joint injection needles, biopsy needles, local ablation applicators, endoscopes, intraoperative imaging modalities (e.g., ultrasound transducers), treatment applicators, and pedicle screws;

[0020] (3) The term "instrument guide" broadly encompasses any and all structures for guiding an interventional instrument to a target location in an anatomical object as known in the art of the present disclosure and hereinafter contemplated. Examples of instrument guides include, but are not limited to, needle guides, acoustic window guides for ultrasound probes, and guide holes with or without specific areas.

[0021] (4) the term "instrument guide base" broadly encompasses all structures known in the art of the present disclosure and hereinafter contemplated that may be mounted to a patient's body for supporting an instrument guide in accordance with the inventive principles of the present disclosure;

[0022] (5) the term "generic instrument template" broadly encompasses any and all geometric representations of instrument guide(s) generally configured for percutaneous interventions in accordance with the inventive principles of the present disclosure as known in the art of the present disclosure and hereinafter contemplated;

[0023] (6) the term "plan-specific instrument template" broadly encompasses any and all instrument guide(s) known in the art of the present disclosure and hereinafter contemplated that are manufactured in accordance with the inventive principles of the present disclosure from the configuration of a general instrument template according to a treatment plan for a specific percutaneous intervention;

[0024] (7) an instrument guide associated with a general instrument template is claimed herein as a general instrument guide, and a guide associated with a plan-specific instrument guide is claimed herein as a planned instrument guide;

[0025] (8) the term "percutaneous interventional system" broadly encompasses any and all percutaneous interventional systems as known in the art of the present disclosure and hereinafter contemplated, and the term "plan-specific instrument template system" broadly encompasses a percutaneous interventional system incorporating the inventive principles of the present disclosure;

[0026] (9) the term "percutaneous interventional method" broadly encompasses any and all percutaneous interventional methods as known in the art of the present disclosure and hereinafter contemplated, and the term "plan-specific instrument template method" broadly encompasses percutaneous interventional methods incorporating the inventive principles of the present disclosure;

[0027] (10) The term "controller" broadly encompasses all structural configurations of a dedicated motherboard or application specific integrated circuit as understood in the art of the present disclosure and as exemplarily described in the present disclosure for controlling the application of the various inventive principles of the present disclosure as exemplarily described in the present disclosure. The structural configuration of a controller may include, but is not limited to, processor(s), computer usable / computer readable storage medium(s), operating system(s), application module(s), peripheral device controller(s), slot(s), and port(s);

[0028] (11) The term "application module" broadly encompasses an application comprised of circuits (e.g., electronic components and / or hardware) and / or executable processes (e.g., executable software and / or firmware stored on (one or more) non-transitory computer-readable media) for executing a particular application that is contained within or accessible by a controller;

[0029] (12) descriptive labels used for application modules described and claimed herein to facilitate distinction between application modules as described and claimed herein without specifying or implying any additional limitation on the term “controller”;

[0030] (13) The term "data" broadly encompasses all forms of detectable physical quantities or pulses (e.g., voltage, current, or magnetic field strength) as understood in the art of the present disclosure and as exemplarily described in the present disclosure for transmitting information and / or instructions supporting the application of various inventive principles of the present disclosure as subsequently described in the present disclosure. Data communications of various components of the present disclosure may involve communication methods as known in the art of the present disclosure, including but not limited to data transmission / reception over any type of wired or wireless data link and reading of data uploaded to a computer-usable / computer-readable storage medium; and

[0031] (14) The descriptive labels used for the term "data" described and claimed herein facilitate distinction between the data as described and claimed herein without specifying or implying any additional limitation of the term "data."

[0032] The above-mentioned embodiments and other embodiments of the invention disclosed herein and various structures and advantages of the invention disclosed herein will become more apparent by reading the following detailed description of various embodiments of the invention disclosed herein in conjunction with the accompanying drawings. The detailed description and the accompanying drawings are merely illustrative of the invention disclosed herein and are not limiting. The scope of the invention disclosed herein is defined by the claims and their equivalents. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1A An exemplary embodiment of the planning phase of a percutaneous intervention incorporating a general instrument template and an intervention guide base in accordance with the inventive principles of the present disclosure is illustrated.

[0034] Figure 1B An exemplary embodiment of a planning phase of an intervention phase including a plan-specific instrument template and an intervention guidance base according to the inventive principles of the present disclosure is illustrated.

[0035] Figure 2A An exemplary embodiment of an interventional guide base according to the inventive principles of the present disclosure is illustrated.

[0036] Figure 2B An exemplary embodiment of a general instrument template according to the inventive principles of this disclosure is illustrated.

[0037] Figure 2C An exemplary embodiment of a plan-specific instrument template base according to the inventive principles of this disclosure is illustrated.

[0038] Figure 3A The invention according to the present disclosure is illustrated Figure 2C Exemplary design of a program-specific instrument template.

[0039] Figure 3B The invention according to the present disclosure is illustrated Figure 2CDemonstration fabrication of a program-specific instrument template.

[0040] Figure 3C The invention according to the present disclosure is illustrated. Figure 2C An exemplary intervention with a program-specific instrument template.

[0041] Figure 4 An exemplary instrument guide design controller according to the inventive principles of this disclosure is illustrated.

[0042] Figure 5 An exemplary flow chart of an instrument guide design method according to the inventive principles of the present disclosure is illustrated.

[0043] Figure 6A-6B Pictured Figure 5 An exemplary execution of the flowchart of FIG.

[0044] Figure 7 An exemplary embodiment of an instrument guide design system according to the inventive principles of this disclosure is illustrated.

[0045] Figure 8 An exemplary embodiment of an instrument guide design controller according to the inventive principles of this disclosure is illustrated.

[0046] FIG. 9A illustrates an exemplary ultrasound array as known in the art of the present disclosure.

[0047] Fig. 9B An exemplary embodiment of an intervention phase of a percutaneous intervention incorporating a plan-specific instrument template and an ultrasound array according to the inventive principles of the present disclosure is illustrated. DETAILED DESCRIPTION

[0048] In order to facilitate the understanding of the various inventions disclosed herein, Figure 1A and 1B The following description teaches the basic inventive principles of the planning phase and the intervention phase of percutaneous intervention according to the present disclosure. From this description, those skilled in the art will recognize how to apply the inventive principles of the present disclosure to additional embodiments of percutaneous intervention according to the inventive principles of the present disclosure.

[0049] refer to Figure 1A The planning stage of a percutaneous intervention according to the present disclosure includes imaging of an intervention guide base 20 relative to an anatomical object 10 that is the subject of the percutaneous intervention. In practice, the imaging can be performed by a imaging modality as known in the art of the present disclosure (e.g., computed tomography ("CT"), cone beam CT, magnetic resonance imaging, ultrasound, positron emission tomography, and single photon emission computed tomography).

[0050] After imaging of the interventional guide base 20 relative to the anatomical object 10, the interventional guide base 20 is segmented by the image, wherein a general instrument template 30 is generated in the form of a computer grid positioned on the segmented interventional guide base 20. The general instrument template 30 includes a platform 31 positioned on the segmented interventional guide base 20. The general instrument template 30 also includes instrument guides 32 extending through the platform, wherein each instrument guide 32 has a general position, general orientation, and general configuration (i.e., shape and size) relative to the platform 31. More specifically, the position, orientation, and configuration of each instrument guide 32 are independent of the percutaneous intervention of the object.

[0051] After the generation and positioning of the generic instrument template 30, a treatment plan is developed to delineate within the image the instrument trajectories of one or more interventional instruments (e.g., needle(s) and / or electrode(s)) that sequentially pass through the generic instrument template 30 and the interventional guide base 20 to reach a target location within the anatomical object 10. For example, Figure 1A As shown in FIG. 1 , two (2) instrument trajectories 50 are delineated to reach two (2) corresponding target locations 11 a and 11 b within the anatomical object 10 through the general instrument template 30 and the interventional guide base 20 .

[0052] For each delineated instrument trajectory 50, the present disclosure provides for repositioning and / or reorienting the instrument guide 32 relative to the platform 31 corresponding to the delineated instrument trajectory. Figure 1A As shown in FIG. 5 , instrument guide 32a may be laterally displaced to a position corresponding to the delineated instrument trajectory 50a, and instrument guide 32e may be laterally displaced to a position corresponding to the delineated instrument trajectory 50b and tilted to an orientation corresponding to the delineated instrument trajectory 50b.

[0053] Moreover, for each delineated instrument trajectory 50, the present disclosure provides for reconfiguration of the shape and / or size of the instrument guide 32 corresponding to the delineated instrument trajectory relative to the platform 31. For example, the length and diameter of a specific instrument guide in the instrument guides 32 can be adjusted to take into account the length and diameter of a specific interventional instrument passing through that specific instrument guide in the instrument guides 32 along the corresponding delineated instrument trajectory, and thereby guide the user not only with respect to the position and orientation of the trajectory but also with respect to the insertion depth. For example, for shallow target locations, the instrument guide can be lengthened and / or narrowed, thereby limiting the depth of the interventional instrument into the anatomical space, and for deeper target locations, the instrument guide can be shortened and / or widened, thereby increasing the depth of the interventional instrument into the anatomical space. Alternatively, the interventional instrument can be marked for deep insertion.

[0054] The present disclosure also provides for the fabrication of a plan-specific instrument template based on each repositioning, each reorientation, and / or each reconfiguration of the instrument guide 32 relative to the platform 31 corresponding to the delineated instrument trajectory 50, and the removal of any unused instrument guide 32 from the platform 31. For example, Figure 1B As shown in the figure, the manufactured plan-specific instrument template 40 includes an instrument guide 42a positioned and oriented relative to platform 41 based on the repositioning of instrument guide 32a relative to platform 31, and also includes an instrument guide 42b positioned and oriented relative to platform 41 based on the repositioning, reorientation and reconfiguration of instrument guide 32e relative to platform 31 and the lengthening of instrument guide 32e.

[0055] refer to Figure 1B The interventional phase of a percutaneous intervention according to the present disclosure includes positioning of a plan-specific instrument template 40 onto an interventional guide base 20, which is positioned relative to an anatomical object 10 as in the planning phase of the percutaneous intervention. After positioning of the plan-specific instrument template 40 onto the interventional guide base 20, an interventional instrument 51a may be sequentially inserted through the instrument guide 42a and the interventional guide base 20 to a target location 11a within the anatomical object 10, and an interventional instrument 51b may be sequentially inserted through the instrument guide 42b and the interventional guide base 20 to a target location 11b within the anatomical object 10. In practice, such insertion of the interventional instrument 51 may be monitored via imaging of the interventional instrument 51 as known in the art of the present disclosure (e.g., computed tomography ("CT"), cone beam CT, magnetic resonance imaging, ultrasound, positron emission tomography, or single photon emission computed tomography) and / or tracking of the interventional instrument 41 as known in the art of the present disclosure (e.g., electromagnetic tracking, optical tracking, optical shape sensing, or marker-based tracking). Also in practice, as previously described, each instrument guide may be lengthened or shortened during the planning phase to thereby adjust the insertion depth of the corresponding interventional instrument.

[0056] refer to Figure 1A and 1B In practice, the interventional guide base 20 can have a material composition and geometric configuration suitable for one or more specific types of percutaneous interventions. Also in practice, the interventional guide base 20 can be attached to the patient's body, mounted on the patient's body, or otherwise attached to the patient's body during the planning and intervention stages of the percutaneous interventions of the present disclosure.

[0057] exist Figure 2AIn one embodiment shown in , the interventional guide base 120 employs a frame 121 having an instrument channel 122, wherein the frame 121 also has a degree of flexibility to conform to the shape of the patient's body. The frame 121 includes a set of uniquely spaced attachment pins 123 located on the top surface to enable easier assembly of the interventional guide base to the plan-specific instrument template 40. The lower surface of the frame 121 includes a self-adhesive tape (not shown), for example, hypoallergenic tape used in urology or under electrocardiogram electrodes as known in the field of the present disclosure. Optionally, in order to achieve accurate segmentation of the interventional guide base 20 within the volumetric image, the frame 121 can include a set of internal radiopaque markers or other materials that can be distinguished from the human tissue attenuation coefficient.

[0058] In addition, the self-adhesive base can be reinforced with an attachment strap that wraps around the patient's body as is known in the art of the present disclosure. Such a strap can also allow for dynamic placement of multiple instrument guide bases for different parts of a procedure, and can also allow for quick clipping and removal of different instrument guide bases in the event of intraoperative changes.

[0059] refer to Figure 1A In practice, the generic instrument template 30 is a computer mesh that geometrically represents a planning-specific instrument template for one or more specific types of percutaneous interventions.

[0060] exist Figure 2B In one embodiment shown in FIG. 1 , a generic instrument template 130 includes a platform 131 in the form of a general 3D triangular mesh with a set of generally positioned and oriented, evenly spaced models of instrument guides 132 on the platform 131. This general mesh is deformable based on information from both the volumetric image and the treatment plan as previously described in the present disclosure, and the plan-specific instrument template 140 ( Figure 2C )’s geometric representation.

[0061] Further, the lower surface of the platform 131 includes a pin ( Figure 2A )A set of holes (not shown) in a unique configuration defined by the adhesive tape. Other possible attachment mechanisms (such as self-adhesive tape) are also possible.

[0062] refer to Figure 1B In practice, the deformed general instrument template 30 is input into an additive manufacturing system (e.g., a 3D printer) or a subtractive manufacturing system to manufacture the planning-specific instrument template 40 therefrom.

[0063] In such Figure 2B and 2CIn one embodiment shown in , the deformed general instrument template 130 is stored in a file format (e.g., an STL file format, an .OBJ file format, or a .VRML file format) that can be used by an additive manufacturing system or a subtractive manufacturing system, wherein the file format is used to manufacture a plan-specific instrument template 140.

[0064] Although the instrument guide 142 is shown as having a tubular section extending from the platform 141 , in reality the instrument guide may be completely integrated into the platform 141 without any extending tubular section.

[0065] Furthermore, in practice, the instrument guide 142 may be made of a flexible material, so that the user can adjust the position, orientation, and / or configuration of the instrument guide 142 as needed. Moreover, the instrument guide 142 may be a combination of a rigid material and a flexible material, wherein the user can slightly adjust the position, orientation, and / or configuration of the instrument guide 142 within a specific range as needed.

[0066] Also in practice, the multi-material instrument guide 142 can be manufactured to measure the insertion depth of the interventional instrument relative to the target location. For example, in the case of a semi-flexible instrument guide 142, the material can compress to indicate the proximity to the target location. In addition, the instrument guide 142 can also be printed with a fixed motion ball joint to accommodate motion in one or more planes (e.g., only allowing 'x' degrees of motion in certain planes).

[0067] refer to Figure 1B , the plan-specific instrument template 40 will typically be designed and manufactured preoperatively during the planning phase. In practice, however, the plan-specific instrument template 40 may be designed preoperatively during the planning phase and manufactured intraoperatively during the interventional phase. Issues associated with intraoperative manufacturing of the plan-specific instrument template 40 during the interventional phase include (1) speed of manufacturing, (2) biocompatibility, and (3) sterilization after production.

[0068] For example, a high-speed additive manufacturing process or a high-speed subtractive manufacturing process as known in the art of the present disclosure can be used to meet the time constraints of the percutaneous intervention (e.g., a few minutes). Further, although the planning-specific instrument template 40 will generally have limited contact with the patient's body and a very short exposure time, the planning-specific instrument template 40 should have a material composition according to medical regulatory standards (e.g., PolyJet photopolymer MED610). Finally, the interventional guide base 20 can be sterilized prior to the percutaneous intervention, during the manufacturing process, the planning-specific instrument template 40 is sterilized using a steam autoclave or plasma or using ethanol (70%) as a sterilant.

[0069] To further understand Figure 2A-2CAn embodiment of Figures 3A-3C An exemplary percutaneous intervention of a patient's spine 110 including an intervention guide base 120 , a generic instrument template 130 , and a plan-specific instrument template 140 is illustrated.

[0070] Figure 3A The illustration shows an image segmented interventional guide base 120 flexibly and adhesively attached to a patient's body 112 whereby a treatment plan of two (2) instrument paths 150a and 150b is planned to a target location within the spine 111 to thereby facilitate deformation of the instrument guides 132a and 132b of a general instrument template 130 according to the treatment plan.

[0071] Figure 3B The fabrication of a planning-specific interventional template 140 with two instrument guides 142a and 142b prior to attachment of the planning-specific interventional template 140 to the interventional guide base 120 is illustrated.

[0072] Figure 3C The installation of a plan-specific interventional guide 140 onto the interventional guide base 120 is illustrated, whereby an interventional instrument 151 can be accurately guided to a target location in the spine 110 .

[0073] In order to facilitate further understanding of the various inventions disclosed herein, Figure 4 and 5 The following description teaches the basic inventive principles of the instrument guide design controller and the instrument guide design method of the present disclosure. Based on this description, those skilled in the art will recognize how to apply the inventive principles of the present disclosure to additional embodiments of making and using the instrument guide design controller and the instrument guide design method of the present disclosure.

[0074] refer to Figure 4 The instrument guide design controller 60 of the present disclosure inputs the interventional guide base image file 220 (including the interventional guide base of the present disclosure (eg, Figure 2A The apparatus further comprises: inputting (or alternatively storing) a general instrument template file 230 (including a general instrument template for the present disclosure (e.g., Figure 2B Based on the input, the instrument guide design controller 60 outputs a plan-specific instrument template file 240 (including a plan-specific instrument template for the present disclosure (e.g., Figure 2C Data for additive or subtractive manufacturing of a plan-specific instrument template 140) shown in FIG.

[0075] Generally, the instrument guide design controller 60 is configured to (a) segment the interventional guidance base of the present disclosure from a preoperative volume image or an intraoperative volume image, (b) define a treatment plan including multiple instrument trajectories / paths via a general instrument template of the present disclosure, and (c) design a plan-specific instrument template of the present disclosure.

[0076] During the segmentation process, the instrument guide design controller 60 automatically segments the interventional guide base of the present disclosure from the volumetric image using one of the methods known in the art of the present disclosure (e.g., thresholding, level set, or active contour segmentation algorithms) or via manual segmentation by outlining of the interventional guide base.

[0077] Defining a treatment plan includes identifying an interventional instrument trajectory / path by a user of the instrument guide design controller 60 via a graphical user interface on a volumetric image (e.g., CT, CBCT, MRI, PET-CT, etc.). Examples of interventional instruments suitable for treatment include, but are not limited to, radiofrequency instruments, microwave or electroporation electrodes, facet injection needles, biopsy needles, local ablation applicators, endoscopes, intraoperative imaging modalities (e.g., ultrasound transducers), treatment applicators, and pedicle screws. The instrument path is defined as a point-to-point needle entry path to reach the clinical site percutaneously, and the instrument path consists of a target location and a skin entry point. Preferably, the trajectory is manually defined by a user of the instrument guide design controller 60, but other automatic methods that include both the location of the instrument guide base and anatomical knowledge of the surgical site may be applied as known in the art of the present disclosure.

[0078] The design of the plan-specific instrument template is derived from variations of the general instrument template according to the treatment plan as previously described in this disclosure.

[0079] In one embodiment, the instrument guide design controller 60 performs the following steps: Figure 5 100 is a flowchart of the instrument guide design method of the present disclosure. Figure 2A-2C An exemplary percutaneous intervention of a patient's spine using the interventional guide base 120, the general instrument template 130, and the plan-specific instrument template 140 is described, but those skilled in the art should recognize how to apply the flowchart 100 to any embodiment of the interventional guide base, the general instrument template, and the plan-specific instrument template of the present disclosure.

[0080] refer to Figure 5, prior to image acquisition, stage S102 of flowchart 100 includes the physician / clinician attaching the self-adhesive instrument guide base 120a over the surgical site. In practice, the physician / clinician's determination of the correct position of the instrument guide base 120a over the surgical site may require (one or more) prior diagnostic scans or the use of wires previously attached around the surgical site. For this example, the surgical site is a level in the spine where pedicle screws will be implanted. In one embodiment, the instrument guide base 120a is used in an area of ​​the patient's body that is not susceptible to respiratory motion and soft tissue deformation. Due to any degree of rigidity of the instrument guide base 120, respiratory motion can significantly affect the instrument positioning accuracy of the plan-specific instrument template 140 due to organ motion. In another embodiment, coupling or registration of the instrument guide base 120 with a real-time imaging modality can improve the ability of the plan-specific instrument template 140 in dynamic motion of the patient's body.

[0081] After placement of the instrument guide base 120, a volumetric image data set is acquired and transmitted as a file 220 to the instrument guide design controller 60 ( Figure 4 ). Fig. 6A Exemplary imaging 200 of instrument guide base 120 relative to spine 211 is illustrated.

[0082] Still reference Figure 5 , stage S104 of flowchart 100 includes the instrument guide design controller 60 generating a model 120b of the instrument guide base 120a via image segmentation 201, such as Figure 6B More specifically, during image segmentation, voxels belonging to a particular object are grouped and labeled using an arbitrary scalar value. The use of a material made of the instrument guide base 120b that has a unique attenuation coefficient compared to human tissue can simplify the process. After segmentation, stage S140 also includes the instrument guide design controller 60a generating a method known in the art of the present disclosure (e.g., Delaunay triangulation) such as Figure 6C 2. As a post-processing step, the generic instrument template 130a may be simplified and cleaned using an extraction method.

[0083] Still reference Figure 5 , stage S106 of flowchart 100 includes instrument guide design controller 60 facilitating a defined treatment plan within image 203 including single or multiple instrument trajectories (e.g., Fig.6D150a and 150b shown in FIG. 150b). In one embodiment, the instrument trajectory is manually defined by a physician / clinician. Alternatively, in another embodiment, other automated methods that include both the position of the model 120b of the instrument guide base 120a and anatomical knowledge of the surgical site may be used by the instrument guide design controller 60 to define the instrument trajectory.

[0084] Still reference Figure 5 , stage S108 of 100 includes the instrument guide design controller 60 planning the 3D model 140a of the specific multi-needle template 140 based on the model 120b of the instrument guide base 120a, the general instrument template 130a, and the treatment plan design including the desired instrument trajectory.

[0085] In one embodiment, the instrument guide design controller 60 introduces the general instrument template 130a to elastic deformation using one of the deformable model algorithms (e.g., deformable surface or level set) known in the field of the present disclosure and successfully applied in non-rigid image registration, finite element analysis and other simulations. During elastic deformation, the internal deformation energy can expand the general mesh under the constraints imposed by the upper surface of the model 120b of the instrument guide base 120a and the attachment pins. In a simplified version, the upper surface of the model 120b of the instrument guide base 120a will define the lower surface of the general instrument template 130a, wherein the lower surface of the general instrument template 130a will be expanded in the opposite direction of the patient's body to reach a certain thickness (e.g., 2 mm). The attachment pins on the model 120b will generate their counterparts - attachment holes on the lower surface of the general instrument template 130. The location of the through hole (entry point) for the needle is defined as the intersection between the instrument trajectory and the upper surface of the general instrument template 130a. The diameter of the through hole of the instrument guide is defined by the known diameter of the instrument (known a priori from an internal database). The length of the instrument guide is defined by subtracting the length of the vector defined by the entry point on the upper surface of the target and generic instrument template 130a from the instrument length (known a priori from an internal database). The orientation of the instrument guide is calculated according to the instrument orientation angle derived from the treatment plan.

[0086] After termination of the flowchart 100 , the plan-specific instrument template file 240 enables additive or subtractive manufacturing of the plan-specific instrument template 140 .

[0087] In order to facilitate further understanding of the various inventions disclosed herein, Figure 4 and 5 The following description teaches the basic inventive principles of the instrument guide design system of the present disclosure. From this description, those skilled in the art will recognize how to apply the inventive principles of the present disclosure to make and use additional embodiments of the instrument guide design system of the present disclosure.

[0088] refer to Figure 8 The instrument guide design controller 60 of the present disclosure is installed in an application server 80 that can be accessed by multiple clients (for example, client 81 and client 82 as shown in the figure), and / or is installed in a workstation 83 using a monitor 84, a keyboard 85 and a computer 86.

[0089] In operation, the instrument guide design controller 60 inputs an instrument guide base image file 220 ( Figure 4 ) to output a plan-specific instrument template file 240 ( Figure 4 ), the plan-specific instrument template file 240 is transmitted by the controller 60 to one or more manufacturing sources 90 (including but not limited to an additive manufacturing system 91 (e.g., a 3D printer) and a subtractive manufacturing system 92 (e.g., a CNC machine)).

[0090] In practice, the instrument guide design controller 60 may be implemented as hardware / circuitry / software / firmware.

[0091] 9, the instrument guide design controller 160 includes a processor 161, a memory 162, a user interface 163, a network interface 164, and a storage device 165 interconnected via one or more system buses 166. In practice, the actual organization of the components 161-165 of the controller 160a will be more complex than illustrated.

[0092] Processor 161 may be any hardware device capable of executing instructions stored in a memory or storage device or otherwise processing data. Therefore, processor 161 may include a microprocessor, a field programmable gate array (FPGA), an application specific integrated circuit (ASIC) or other similar device.

[0093] Memory 162 may include various memories, such as L1, L2 or L3 cache or system memory. Therefore, memory 162 may include static random access memory (SRAM), dynamic RAM (DRAM), flash memory, read-only memory (ROM) or other similar memory devices.

[0094] User interface 163 may include one or more devices for implementing communication with a user (such as an administrator). For example, user interface 163 may include a display, a mouse, and a keyboard for receiving user commands. In some embodiments, user interface 163 may include a command line interface or a graphical user interface that may be presented to a remote terminal via network interface 164.

[0095] The network interface 164 may include one or more devices for implementing communication with other hardware devices. For example, the network interface 164 may include a network interface card (NIC) configured to communicate according to the Ethernet protocol. In addition, the network interface 164 may implement a TCP / IP stack for communicating with the TCP / IP protocol. Various alternative or additional hardware or configurations for the network interface will be apparent.

[0096] The storage device 165 may include one or more machine-readable storage media, including but not limited to read-only memory (ROM), random access memory (RAM), magnetic disk storage media, optical storage media, flash memory devices, or similar storage media. In various embodiments, the storage device 165 may store instructions for execution by the processor 161 or data that the processor 161 may operate on. For example, the storage device 165 may store a basic operating system for controlling various basic operations of the hardware.

[0097] More specifically to the present disclosure, the storage device 165 also stores a control module 167 .

[0098] The first control module 167 is used to perform image segmentation of the base of the instrument guide of the present disclosure and mesh generation of the general instrument template of the present disclosure (e.g., Figure 5 104 ) of the general instrument template generator 167 a of stage S104 of the flowchart 100 shown in FIG.

[0099] The second control module 167 is used to perform instrument trajectory drawing (e.g., Figure 5 The treatment planner 167b of stage S106 of the flowchart 100 shown in FIG.

[0100] The third control module 167 is for performing mesh generation of the general instrument template of the present disclosure according to the deformation of the treatment plan to thereby design the plan-specific instrument template of the present disclosure (e.g., Figure 5 100 of stage S106) shown in the flowchart 100 of the plan-specific instrument template designer 167c.

[0101] refer to Figure 1A and 1B Although instrument guide base 20 of the present disclosure is important to the planning phase of the percutaneous intervention of the present disclosure, alternative devices may replace instrument guide base 20 during the intervention phase of the percutaneous intervention of the present disclosure.

[0102] For example, FIG. 9A illustrates a bottom view of a large ultrasound array 300 having an instrument through hole 301 as known in the art of the present disclosure, and Fig. 9BThe mounting of a plan-specific instrument template 40 onto the top surface of a large ultrasound array 300 is illustrated, whereby the instrument trajectories extend through through-holes 301 of the large ultrasound array 300. This exemplary embodiment provides a real-time guidance and safety means for instrument insertion, especially when the clinical site is in respiratory motion.

[0103] 1-9, those skilled in the art will recognize the many benefits of the presently disclosed invention, including but not limited to configurable instrument guides supporting more accurate insertion of interventional instruments into a surgical site than non-configurable instrument guides as known in the art of the present disclosure.

[0104] In addition, in view of the teachings provided herein, those skilled in the art will appreciate that the structures, elements, components, etc. described in this disclosure / specification and / or depicted in the accompanying drawings can be implemented in various combinations of hardware and software, and provide functions that can be combined in a single element or multiple elements. For example, the functions of the various structures, elements, components, etc. shown / illustrated / depicted in the accompanying drawings can be provided by using dedicated hardware and hardware capable of running software associated with appropriate software for adding functionality. When provided by a processor, the function can be provided by a single dedicated processor, a single shared processor, or multiple individual processors, some of which can be shared and / or reused. In addition, the explicit use of the term "processor" or "controller" should not be interpreted as exclusively referring to hardware capable of running software, and may implicitly include, but is not limited to, digital signal processor ("DSP") hardware, memory (e.g., read-only memory ("ROM"), random access memory ("RAM"), non-volatile memory, etc. for storing software) and any module and / or machine (including hardware, software, firmware, and combinations thereof, etc.) that can (and / or can be configured to) execute and / or control a process.

[0105] In addition, all statements of the principles, aspects and embodiments of the present invention and its specific examples are intended to cover both its structure and functional equivalents herein. In addition, such equivalents are intended to include currently known equivalents and equivalents developed in the future (for example, any element of the developed function that can perform the same or substantially similar function, regardless of structure). Therefore, for example, in view of the teaching provided herein, those skilled in the art will appreciate that any block diagram presented herein can represent the conceptual view of the illustrative system components and / or circuits realizing the principles of the present invention. Similarly, in view of the teaching provided herein, those of ordinary skill in the art should appreciate that any flow chart, flow diagram, etc. can represent various processes, and the various processes can be represented in a computer-readable storage medium substantially, and therefore operated by a computer, a processor or other devices with processing power, regardless of whether such a computer or a processor is explicitly shown.

[0106] Having described preferred and exemplary embodiments of various and many inventions of the present disclosure (which embodiments are intended to be illustrative rather than restrictive), it should be noted that modifications and variations may be made by those skilled in the art in view of the teachings provided herein including the drawings. It should therefore be understood that the preferred and exemplary embodiments of the present disclosure may be changed within the scope of the embodiments disclosed herein.

[0107] In addition, it is contemplated that corresponding and / or related systems that incorporate and / or implement the devices / systems or such as can be used / implemented in / with devices according to the present disclosure are also contemplated and considered to be within the scope of the present disclosure. In addition, corresponding and / or related methods for making and / or using devices and / or systems according to the present disclosure are also contemplated and considered to be within the scope of the present disclosure.

Claims

1. A plan-specific instrument template system for percutaneous intervention, the plan-specific instrument template system comprising: An intervention guide base (20); as well as An instrument guide design controller (60) for controlling the design of a plan-specific instrument template (40), the plan-specific instrument template comprising a platform and at least one planned instrument guide (42), the at least one planned instrument guide extending through the platform for guiding at least one interventional instrument during the percutaneous intervention, wherein the instrument guide design controller (60) is configured to: generating and positioning a general instrument template (30) relative to the image segmentation of the interventional guide base (20), The general instrument template (30) comprises a platform (31) and at least one general instrument guide (32), and wherein the one or each general instrument guide (32) of the general instrument template (30) has a general position and a general orientation relative to the general configuration of the platform (31) of the general instrument template (30); and controlling at least one of repositioning, reorienting or reconfiguring the one or each general instrument guide (32) of the general instrument template (30) relative to the platform (31) of the general instrument template (30) in accordance with a treatment plan associated with the percutaneous intervention, Therein, the general instrument template (30) forms a geometric representation of the plan-specific instrument template (40).

2. The plan-specific instrument template system according to claim 1, wherein: The instrument guide design controller (60) is also configured to: inputting a volume image data set indicating an image of the interventional guidance base (20); and Image segmentation is performed on the interventional guidance base (20).

3. The plan-specific instrument template system of claim 1, wherein: The instrument guide design controller (60) is also configured to: At least one of the following: inputting and storing a general instrument template data set used to generate the general instrument template (30).

4. The plan-specific instrument template system of claim 1, wherein: The instrument guide design controller (60) is also configured to: Delineation of at least one instrument trajectory sequentially extending through the generated guide instrument guide and the interventional guide base (20) is controlled according to the treatment plan.

5. The plan-specific instrument template system of claim 4, wherein: The instrument guide design controller (60) is also configured to: At least one of the repositioning, reorientation and reconfiguration of the one general instrument guide (32) or each general instrument guide (32) of the general instrument template (30) relative to the platform (31) of the general instrument template (30) is controlled based on the at least one outlined instrument trajectory.

6. The plan-specific instrument template system of claim 1, wherein: The instrument guide design controller (60) is also configured to: The geometric configuration of the platform (31) of the generic instrument template (30) is elastically deformed to correspond to the geometric configuration of the interventional guide base (20).

7. The plan-specific instrument template system of claim 4, wherein: The instrument guide design controller (60) is also configured to: The plan-specific instrument template data set is output for at least one of additive manufacturing and subtractive manufacturing of the plan-specific instrument template (40).

8. The plan-specific instrument template system of claim 4, wherein: The instrument guide design controller (60) is installed in one of an application server or a workstation.

9. An instrument guide design controller (60) for controlling the design of a plan-specific instrument template (40), the plan-specific instrument template comprising a platform and at least one planned instrument guide (42), the at least one planned instrument guide extending through the platform for guiding an instrument during a percutaneous intervention, the instrument guide design controller (60) comprising: a general instrument template (30) generator configured to generate and position the general instrument template (30) relative to the image segmentation of the interventional guidance base (20), The general instrument template (30) comprises a platform (31) and at least one general instrument guide (32), and wherein the one or each general instrument guide (32) of the general instrument template (30) has a general position and a general orientation relative to the general configuration of the platform (31) of the general instrument template (30); and a plan-specific instrument template (40) designer configured to control at least one of repositioning, reorienting or reconfiguring the one or each general instrument guide (32) of the general instrument template (30) relative to the platform (31) of the general instrument template (30) in accordance with a treatment plan associated with the percutaneous intervention, Therein, the general instrument template (30) forms a geometric representation of the plan-specific instrument template (40).

10. The instrument guide design controller (60) according to claim 9, wherein: The general instrument template (30) generator is further configured to: inputting a volume image data set indicating an image of the interventional guidance base (20); and Image segmentation is performed on the interventional guidance base (20).

11. The instrument guide design controller (60) according to claim 9, wherein: The general instrument template (30) generator is further configured to: At least one of the following: inputting and storing a general instrument template data set used to generate the general instrument template (30).

12. The instrument guide design controller (60) according to claim 9, further comprising: A treatment planner is configured to control the delineation of at least one instrument trajectory sequentially extending through the generated guide instrument guide and the interventional guide base (20) according to the treatment plan.

13. The instrument guide design controller (60) according to claim 12, wherein: The plan-specific instrument template (40) designer is further configured to: At least one of the repositioning, reorientation and reconfiguration of the one general instrument guide (32) or each general instrument guide (32) of the general instrument template (30) relative to the platform (31) of the general instrument template (30) is controlled based on the at least one outlined instrument trajectory.

14. The instrument guide design controller (60) according to claim 9, wherein: The general instrument template (30) generator is further configured to: The geometric configuration of the platform (31) of the generic instrument template (30) is elastically deformed to correspond to the geometric configuration of the interventional guide base (20).

15. The instrument guide design controller (60) according to claim 9, wherein: The plan-specific instrument template (40) designer is further configured to: The plan-specific instrument template data set is output for at least one of additive manufacturing and subtractive manufacturing of the plan-specific instrument template (40).

Images