WO2017122076A2

WO2017122076A2 - Flexible patient specific instrument

Info

Publication number: WO2017122076A2
Application number: PCT/IB2016/058093
Authority: WO
Inventors: David Paul Noonan; Aleksandra Popovic; Neriman Nicoletta Kahya
Original assignee: Koninklijke Philips NV
Current assignee: Koninklijke Philips NV
Priority date: 2016-01-15
Filing date: 2016-12-30
Publication date: 2017-07-20
Anticipated expiration: 2018-07-15
Also published as: WO2017122076A3

Abstract

A method for designing and manufacturing a base operating configuration of a flexible patient specific instrument (91) to follow an anatomical path relative to an anatomical structure. The method involves generating a diagnostic scan of the anatomical structure, and delineating an instrument design path relative to the anatomical structure based on a scanned configuration of the anatomical path as illustrated in the diagnostic scan of the anatomical structure. The method further involves rendering a design of the base operating configuration of the flexible patient specific instrument (91) following a portion or an entirety of the instrument design path, and additive manufacturing and/or subtractive manufacturing of flexible patient specific instrument (91) in the base operating configuration and/or a mold of the flexible patient specific instrument (91) in the base operating configuration.

Description

FLEXIBLE PATIENT SPECIFIC INSTRUMENT

FIELD OF THE INVENTION

The present disclosure generally relates to flexible instruments for performing any type of medical procedure. The present disclosure specifically relates to flexible patient specific instrument having a base operating configuration following an anatomical path through and/or traversing across an anatomical structure as illustrated in a diagnostic scan of the anatomical structure.

BACKGROUND OF THE INVENTION

In-patient flexible tubing has many applications within the medical domain.

For example, referring to FIG. 1, a nasogastric tubing 40 of a patient 10 provides an access route to a stomach 11 through a nasal cavity 12. Typical use cases of nasogastric tubing 40 include patients in Intensive Care Unit (ICU) who are unable to swallow food due to sedation/paralysis, or patients with degenerative muscular disease who are unable to swallow or induce peristaltic motion. Such tubing can be left in place for short or medium term durations.

By further example, still referring to FIG. 1, an endotracheal intubation tubing 41 provides access to the upper airways of the lung (not shown) via passage through a mouth 21 of a patient 20 and stabilization next to an esophagus 22 of patient 12. Endotracheal intubation tubing 41 is used in conjunction with a ventilator (not shown) to facilitate ventilation of the lungs. Typical use cases of endotracheal intubation tubing 20 include the ICU, where the ventilator 'breathes' for the patient, or in surgery, where gaseous anesthesia is added to the oxygen rich air which is forced into the patients lungs.

For nasogastric tubing 40 and endotracheal intubation tubing 41 as known in the art, the tubing involved is produced from silicone, polyurethane or similar material, with the nasogastric tubing 40 being considerably more flexible than the endotracheal intubation tubing 41. The material properties of the tubing is related to the pathways the tubing must follow inside the body, and the manner of introduction into the body. Currently clinicians deploy such tubing by either blindly feeding it in through the nose in the case of nasogastric tubing 40) or using tools such as a laryngoscope in the case of intubation tubing 41. Distance markings along the tubing indicate the depth inside the patient. Once in place, the tubing being generalized for a multitude of patients either adapts to the natural anatomical pathways of the body, displaces the soft tissue, or a combination of both. In certain cases the displacement of the soft tissue and crude insertion methodology may cause significant patient discomfort and clinical complications. Additionally, once set in place the tubing is typically tied or taped to the patient's face to prohibit additional movement. There is considerable clinical risk to the patient if the tubing is deployed at the wrong location, or if the tubing moves during a procedure.

A Cox-maze procedure is a surgical procedure to treat atrial fibrillation. During this procedure, a surgeon ablates atrium of patient's heart in a maze like pattern as known in the art. In a traditional Cox-maze procedure, a sternotomy and rib spreading is required to access the atrium of the heart. Due to invasiveness of this procedure, it is rarely performed as a stand-alone treatment. Open Cox-maze is usually done adjacent to other heart procedures, such as bypass or valve surgery.

Minimally invasive procedures attempt to solve this problem by accessing the heart through small ports between the ribs.

For example, as shown in FIG. 1, a minimally invasive Cox-maze procedure involves accessing a heart 30 through small ports between the ribs (not shown) and passing a flexible ablation probe 42 around heart 30 until flexible ablation probe 42 'wraps' around left and right pulmonary veins 31 adjacent chambers 32 of heart 30. This is a complex procedure which involves multiple incisions and insertion of rigid devices from both sides in an attempt to pass the electrode around heart 30. Additionally, when flexible ablation probe 42 is in place, it is challenging to ensure the ablative elements of probe 42 are fully in contact with the epicardial surface of heart 30 and there are limited options available to a clinician when not all ablation elements of probe 42 are in contact with the epicardial surface of heart 30.

SUMMARY OF THE INVENTION

The present disclosure provides inventive systems, controllers and methods utilizing diagnostic scans of an anatomical structure to produce flexible patient specific instruments having a base operating configuration optimized to a natural anatomical pathway through or traversing across the anatomical structure of a specific patient.

One form of the inventions of the present disclosure is a system for designing a base operating configuration of a flexible patient specific instrument to follow an anatomical path relative to an anatomical structure. The system employs a path planner controller and an instrument design controller.

In operation, the path planning controller controls a delineation of an instrument design path relative to the anatomical structure based on a scanned configuration of the anatomical path as illustrated in a diagnostic scan of the anatomical structure, and the instrument design controller, responsive to a delineation by the path planning controller of the instrument design path, controls a rendering of a design of the base operating configuration of the flexible patient specific instrument following a portion or an entirety of the instrument design path.

A second form of the invention is a system for designing and manufacturing a base operating configuration of a flexible patient specific instrument to follow an anatomical path relative to an anatomical structure. The system employs a diagnostic imaging system and a workstation. The system further employs an additive manufacturing device and/or a subtractive manufacturing device.

In operation, the diagnostic imaging system operable generates a diagnostic scan of the anatomical structure.

The workstation includes a path planning controller, responsive to a generation by the diagnostic imaging system of the diagnostic scan of the anatomical structure, controlling a delineation of an instrument design path relative to the anatomical structure based on a scanned configuration of the anatomical path as illustrated in the diagnostic scan of the anatomical structure.

The workstation further includes an instrument design controller, responsive to a delineation by the path planning controller of the instrument design path, controlling a rendering of a design of the base operating configuration of the flexible patient specific instrument following a portion or an entirety of the instrument deign path.

The additive manufacturing device and a subtractive manufacturing device, responsive to a rendering of the design by the instrument design controller of the base operating configuration of the flexible patient specific instrument, manufacture the flexible patient specific instrument in the base operating configuration and/or a mold of the flexible patient specific instrument in the base operating configuration.

A third form of the inventions of the present disclosure is a method for designing and manufacturing a base operating configuration of a flexible patient specific instrument to follow a scanned configuration of an anatomical path relative to an anatomical structure.

The method involves generating a diagnostic scan of the anatomical structure, and delineating an instrument design path relative to the anatomical structure based on a scanned configuration of the anatomical path as illustrated in the diagnostic scan of the anatomical structure.

The method further involves rendering a design of the base operating configuration of the flexible patient specific instrument following a portion or an entirety of the instrument design path, and additive manufacturing and/or subtractive manufacturing of flexible patient specific instrument in the base operating configuration and/or a mold of the flexible patient specific instrument in the base operating configuration.

For purposes of the present disclosure,

(1) the term "flexible patient specific instrument" broadly encompasses, as understood in the art of the present disclosure and as exemplary described herein, an instrument produced for any medical procedure and having a base operating configuration optimized to follow a natural anatomical pathway through or traversing across an anatomical structure of a specific patient, and the term "base operating configuration" broadly encompasses an original configuration of a flexible patient specific instrument established by a material composition of the instrument having a memory property. Examples of the material composition include, but is not limited to, any shape memory alloy (e.g., Nickel- titanium alloy);

(2) the term "controller" broadly encompasses all structural configurations, as understood in the art of the present disclosure and as exemplary described herein, of an application specific main board or an application specific integrated circuit 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). The controller may be housed or linked to a workstation. Examples of a workstation include, but are not limited to, an assembly of one or more computing devices (e.g., a client computer, a desktop and a tablet), a display/monitor, and one or more input devices (e.g., a keyboard, joysticks and mouse);

(3) any descriptive labeling of a controller herein (e.g., a "path planning" controller, and a "instrument design " controller) serves to identify a particular controller as described and claimed herein without specifying or implying any additional limitation to the term "controller";

(4) the term "module" broadly encompasses a component of the controller consisting of an electronic circuit and/or an executable program (e.g., executable software and/firmware) for executing a specific application;

(5) any descriptive labeling of an application module herein (e.g., a "path planning" module and an "instrument design" module etc.) serves to identify a particular application module as described and claimed herein without specifying or implying any additional limitation to the term "application module"; (6) the term "diagnostic imaging system" broadly encompasses any system, as understood in the art of the present disclosure and as exemplary described herein, utilized for imaging purpose during any type of medical/surgical procedure. Examples of a diagnostic imaging system include, but are not limited to, an X-ray imaging system, a computed tomography imaging system, a magnetic resonance imaging system, an ultrasound imaging system, and an endoscopic imaging system;

(7) the term "additive manufacturing device" broadly encompasses any device, as understood in the art of the present disclosure and as exemplary described herein, for a computer-aided synthesizing of a three-dimensional (3D) object based on a 3D model of the object or other electronic data source (e.g., a fusing of material layers to produce the 3D object as set forth in a computer-aided design of the 3D object). An example of an additive manufacturing device includes, but is not limited to, a 3D printer;

(8) the term "subtractive manufacturing device" broadly encompasses any device, as understood in the art of the present disclosure and as exemplary described herein, for a computer-aided sculpting of a three-dimensional (3D) object based on a 3D model of the object or other electronic data source (e.g., a removal of layers from the 3D object as set forth in a computer-aided design of the 3D object). An example of a subtractive manufacturing device includes, but is not limited to, a CNC machine;

(9) additional terms of the art, including but are not limited to, "anatomical path", "anatomical structure", "path planning", "instrument design", and "scanned configuration", and any tenses thereof broadly encompass such terms as understood in the art of the present disclosure and as exemplary described herein; and

(10) the term "follow" or any tense thereof broadly encompasses, as understood in the art of the present disclosure and as exemplary described herein, an equivalency, a correspondence, a substantial/exact copy, a mirror image and all other synonyms thereof.

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.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates an exemplary nasogastric tubing, an exemplary endotracheal intubation and an exemplary epicardial ablation as known in the art. FIG. 2 illustrates an exemplary nasogastric tubing, an exemplary endotracheal intubation and an exemplary epicardial ablation in accordance with the inventive principles of the present disclosure.

FIG. 3 illustrates a flowchart representative of an exemplary embodiment a designing and manufacturing method for producing a flexible patient specific instrument in accordance with the inventive principle of the present disclosure.

FIG. 4 illustrates an exemplary design and manufacture of flexible patient specific nasogastric tube in accordance with the inventive principles of the present disclosure.

FIG. 5 illustrates an exemplary design and manufacture of flexible patient specific endotracheal intubation tube in accordance with the inventive principles of the present disclosure.

FIG. 6 illustrates an exemplary design and manufacture of flexible patient specific epicardial ablation probe in accordance with the inventive principles of the present disclosure.

FIGS. 7 A and 7B illustrate exemplary embodiments of a designing and manufacturing system for producing a flexible patient specific instrument in accordance with the inventive principles of the present disclosure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

To facilitate an understanding of the present disclosure, the following description of FIG. 2 teaches basic inventive principles of a flexible patient specific instrument of the present disclosure. From this description, those having ordinary skill in the art will appreciate how to apply the inventive principles of the present disclosure to numerous and various types of flexible patient specific instruments of the present disclosure.

Referring to FIG. 2, a flexible patient specific nasogastric feeding tube 13 of the present disclosure is shown wherein the patient specific nasogastric feeding tube 13 is designed to follow an anatomical pathway from nasal passage 12 to stomach 11 of a specific patient 10. For this embodiment, tube 13 is flexible to enable insertion into the anatomical pathway, yet returns to its original shape once tube 13 is in a final position established by a custom proximal position marker 14 that fits into a nose of patient 10, thus effectively registering the position of tube 13 with respect to patient 10 and a diagnostic scan.

Still referring to FIG. 2, a flexible patient specific intubation tube 23 of the present disclosure is shown wherein the flexible patient specific intubation 23 is designed to follow an anatomical pathway from mouth 21 to esophagus 22 of a specific patient 10. For this embodiment, tube 23 is flexible to enable insertion into the anatomical pathway, yet returns to its original shape once tube 23 is in a final position established by a custom proximal position marker 24 which fits into mouth 21 of the patient 20, thus effectively registering the position of tube 23 with respect to patient 20 and a diagnostic scan.

Still referring to FIG. 2, a flexible patient specific ablation probe 33 of the present disclosure has been navigated into position on an epicardial surface of the heart 30 around pulmonary veins 31. As with tubes 14 and 24, probe 33 is produced from a flexible material with shape retention capability (i.e. probe 33 may be deformed but is designed to

substantially return to the original or deployed shape of probe 33). During insertion probe 33 is straightened using a deployment tool (not shown) and advanced around heart 30 from a single incision into the patient. Due to its shape retention properties, probe 33 will naturally want to return to a minimized energy state and will do so once navigated into position. The shape defined by probe 33 will ensure adequate contact between an electrode of probe 33 and the surface of heart 30, thus ensuring complete electrical isolation following ablation.

The purpose of the description of FIG. 2 was to generally establish a basis for specifying distinctions between the known flexible generalized instruments of FIG. 1 and the inventive flexible patient specific instruments of FIG. 2 whereby such distinctions are impractical to visualize relative to an anatomical structure.

To facilitate a further understanding of the present disclosure based on the specified distinctions of FIG. 2, the following description of FIG. 3 shows certain embodiments to teach basic inventive principles of a method for designing and manufacturing flexible patient specific instruments of the present disclosure as represented by a flowchart 50. From this description, those having ordinary skill in the art will further appreciate how to apply the inventive principles of the present disclosure to numerous and various types of flexible patient specific instruments of the present disclosure.

Referring to FIG. 3, a stage S52 of flowchart 50 encompasses a diagnostic imaging system 60 being operated to generate a diagnostic scan 61 of an anatomical structure (e.g., the tubular structure shown in FIG. 3) that is communicated to a path planning controller 70 for delineating an instrument design path along the scanned configuration of the anatomical structure as illustrated in diagnostic scan 61.

In practice, the imaging modality of diagnostic imaging system 60 will be dependent to a degree upon the particular anatomical structure to be diagnostically scanned by diagnostic imaging system 60.

Also in practice, path planning controller 70 incorporates a path planning module for providing an interface facilitating an operator delineation of the instrument design path along the scanned configuration of the anatomical structure as illustrated in diagnostic scan 61 in terms of one or more dimensions (e.g., length, height, width, thickness, etc.). Thus, in certain embodiments, the operator will have the option to modify or adjust the delineated path to meet additional needs. The interface will be dependent to a degree upon the particular imaging modality of system diagnostic imaging system 60. Further in practice, path planning controller 70 may incorporate a custom accessory module for specifying an accessory to be attached to or integrated with the flexible specific patient instrument as will be exemplary described herein, and may incorporate a custom tool module for specifying a tool to be attached to or integrated with the flexible specific patient instrument as will be exemplary described herein.

FIG. 4 illustrates an example of stage S52 (FIG. 3) for a nasogastric procedure. As shown, a diagnostic scan 61a of the anatomical pathway from a nasal cavity 12 to a stomach 11 of a patient 10 facilitates an operator delineation of a path 113 through the anatomical pathway in terms of one or more dimensions. Additionally, the operator may specific a custom accessory, such as, for example, a proximal position marker 114 as shown.

FIG. 5 illustrates an example of stage S52 (FIG. 3) for an endotracheal intubation procedure. As shown, a diagnostic scan 61b of the anatomical pathway from a mouth 21 to an esophagus 22 of a patient 20 facilitates an operator delineation of a path 123 through the anatomical pathway in terms of one or more dimensions. Additionally, the operator may specific a custom accessory, such as, for example, a proximal position marker 124 as shown.

FIG. 6 illustrates an example of stage S52 (FIG. 3) for an epicardial ablation procedure. As shown, a diagnostic scan 61c of the anatomical pathway traversing across chambers 32 of a heart 30 under pulmonary veins 32 facilitates an operator delineation of a path 133 along the anatomical pathway in terms of one or more dimensions. Additionally, the operator may specific a custom tool, such as, for example, an electrode (not shown).

Referring back to FIG. 3, a stage S54 of flowchart 50 encompasses path planning controller 70 generating an instrument design plan 71 informative of the delineation of an instrument design path along the scanned configuration of the anatomical structure as illustrated in diagnostic scan 61. Path planning controller 70 communicates instrument design plan 71 to an instrument design controller 80 whereby instrument design controller 80 controls a design rendering of a base configuration of the flexible patient specific instrument following the instrument design path.

In one embodiment, instrument design controller 80 converts instrument design plan 71 into an instrument design specification file 81 suitable for a computer-aided manufacture of the flexible patient specific instrument. More particularly, independent design controller 80 incorporates a conversion module for converting instrument design plan 71 to instrument design specification file 81 whereby a format of instrument design specification file 81 is dependent upon the particular type of additive/subtractive manufacturing device for manufacturing the flexible patient specific instrument as will be further described herein. In one embodiment, the format of instrument design specification file 81 is a computer-aided design (CAD) specifying curves and figures in two-dimensional (2D) space, and/or curves, surfaces, and solids in three-dimensional (3D) space.

Further in practice, independent design controller 80 may incorporate a custom accessory module for specifying an accessory to be attached to or integrated with the flexible specific patient instrument as will be exemplary described herein, and may incorporate a custom tool module for specifying a tool to be attached to or integrated with the flexible specific patient instrument as will be exemplary described herein.

FIG. 4 illustrates an example of stage S54 (FIG. 3) for a nasogastric procedure. As shown, instrument design plan 71a is converted to instrument design specification file 81a specifying a 3D object including an instrument 213 in a base operating configuration following the instrument design path and thereby following the anatomical pathway.

Additionally, the 3D object includes proximal position marker 214.

FIG. 5 illustrates an example of stage S54 (FIG. 3) for an endotracheal intubation procedure. As shown, instrument design plan 71b is converted to instrument design specification file 81b specifying a 3D object including an instrument 223 in a base operating configuration following the instrument design path and thereby following the anatomical pathway. Additionally, the 3D object includes proximal position marker 224.

FIG. 6 illustrates an example of stage S54 (FIG. 3) for an epicardial ablation procedure. As shown, instrument design plan 71c is converted to instrument design specification file 81c specifying a 3D object including an instrument 233 in a base operating configuration following the instrument design path and thereby following the anatomical pathway as best shown in a top view. Additionally, the 3D object includes a groove within instrument 233 as best shown in cross-sectional view whereby an electrode 135 may be press- fitted into subsequent to the manufacture of the flexible patient specific instrument.

Referring back to FIG. 3, a stage S56 of flowchart 50 encompasses a manufacturing by an additive and/or subtractive manufacturing device 90 in accordance with the instrument design specification file 81.

In one embodiment, manufacturing device 90 is a 3D printer for a computer-aided synthesizing of flexible patient specific instrument 90 or a mold thereof. In a second embodiment, manufacturing device 90 is a CNC machine for a computer- aided sculpting of flexible patient specific instrument 90 or a mold thereof.

In a third embodiment, manufacturing device 90 incorporates both a 3D printer and a CNC machine for a computer-aided synthesizing and sculpting of flexible patient specific instrument 90 or a mold thereof.

FIG. 4 illustrates an example of stage S56 (FIG. 3) for a nasogastric procedure. As shown, flexible patient specific tube 13 (FIG. 2) and proximal positon marker 14 (FIG. 2) are manufactured with a base operating configuration 13a of tube 13 following the instrument design path and thereby following the anatomical pathway of patient 10. In practice, flexible patient specific tube 13 may be deformed as tube 13 is inserted in patient 10 (e.g., a straightening 13b of tube 13 as shown) whereby tube 13 returns to the base operating configuration 13a upon reaching a target position as established by proximal position marker 114 being anchored on the nose of patient 10. FIG. 4 further illustrates an optional tool 15 attached to a distal end of tube 13.

FIG. 5 illustrates an example of stage S54 (FIG. 3) for an endotracheal intubation procedure. As shown, flexible patient specific tube 23 (FIG. 2) and proximal positon marker 24 (FIG. 2) are manufactured with a base operating configuration 23 a of tube 23 following the instrument design path and thereby following the anatomical pathway of patient 20. In practice, flexible patient specific tube 23 may be deformed as tube 23 is inserted in patient 20 (e.g., a straightening 23b of tube 23 as shown) whereby tube 23 returns to the base operating configuration 23a upon reaching a target position as established by proximal position marker 24 being anchored on the nose of patient 10. FIG. 5 further illustrates an optional cuff 25 attached to a distal end of tube 13.

FIG. 6 illustrates an example of stage S56 (FIG. 3) for an epicardial ablation procedure. As shown, flexible patient specific probe 33 (FIG. 2) is manufactured with a base operating configuration 33a of probe 33 following the instrument design path and thereby following the anatomical pathway of traversing chambers 32 of heart 30 underneath veins 31. In practice, flexible patient specific probe 33 may be deformed as probe 33 is inserted in the patient (e.g., a straightening 33b of probe 33 as shown) whereby probe 33 returns to the base operating configuration 33a upon being wrapped around chambers 32 of heart 30 underneath veins 31.

Referring back to FIG. 3, flowchart 50 is terminated upon a satisfactory manufacture of a flexible patient specific instrument of the present disclosure.. Referring to FIGS. 2-6, those having ordinary skill in the art will appreciate numerous benefits of the present disclosure including, but are not limited to, the novel and unique design and manufacture of numerous and various flexible patient specific instruments applicable to medical procedures.

In practice, the controllers of FIG. 3 may be installed within a single workstation or distributed across multiple workstations and/or systems.

For example, FIG. 7 A illustrates workstation 100 having path planning controller 70 and instrument design controller 80 installed therein. Controller 70 and 80 may be segregated or integrated within workstation 100. Workstation 100 is in communication with diagnostic imaging system 60 to receive diagnostic scan 61 therefrom, and in communication with addition/subtractive manufacturing device 90 to transmit instrument configuration design 81 thereto.

By further example, FIG. 7B illustrates path planning controller 70 installed within diagnostic imaging system 60, and instrument design controller 80 installed within additive/subtractive manufacturing device 90. Path planning controller 70 may be segregated from or integrated with other controllers of diagnostic imaging system 60. Similarly, instrument design controller 80 may be segregated from or integrated with other controllers of additive/subtractive manufacturing device 90. Diagnostic imaging system 60 is in communication with addition/subtractive manufacturing device 90 to transmit instrument design plan 71 thereto.

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 FIGS. 2-7 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 FIGS. 2-7 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 design and manufacture of flexible patient specific instruments (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 FIGS. 2-7. 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.

Claims

Claims 1. A system for designing a base operating configuration of a flexible patient specific instrument (91) to follow an anatomical path relative to an anatomical structure, the system comprising:

a path planning controller (70) operable to control a delineation of an instrument design path relative to the anatomical structure based on a scanned configuration of the anatomical path as illustrated in a diagnostic scan of the anatomical structure; and

an instrument design controller (80) operable, responsive to a delineation by the path planning controller (70) of the instrument design path, to control a rendering of a design of the base operating configuration of the flexible patient specific instrument (91) following at least a portion of the instrument design path.

2. The system of claim 1,

wherein the anatomical structure is tubular;

wherein the anatomical path at least partially extends through the anatomical structure; and

wherein the path planning controller (70) is operable to control the delineation of the instrument design path along at least a portion of the at least partial extension by the anatomical path through the anatomical structure as illustrated in the diagnostic scan of the anatomical structure.

3. The system of claim 1,

wherein the anatomical structure has a perimeter;

wherein the anatomical path at least partially traverses across the perimeter of the anatomical structure; and

wherein the path planning controller (70) is operable to control the delineation of the instrument design path along at least a portion of the at least partial traversal by the anatomical path across the perimeter of the anatomical structure as illustrated in the diagnostic scan of the anatomical structure.

4. The system of claim 1, wherein the path planning controller (70) is further operable to control a specification of an accessory to the instrument design path; and

wherein the instrument design controller (80) is further operable, responsive to a specification by the path planning controller (70) of the accessory, to control the rendering of the design of the base operating configuration of the flexible patient specific instrument (91) inclusive of the accessory.

5. The system of claim 1,

wherein the path planning controller (70) is further operable to control a specification of a tool relative to the instrument design path; and

wherein the instrument design controller (80) is further operable, responsive to a specification by the path planning controller (70) of the tool, to control the rendering of the design of the base operating configuration of the flexible patient specific instrument (91) inclusive of the tool.

6. The system of claim 1,

wherein the instrument design controller (80) is further operable, responsive to the delineation by the path planning controller (70) of the instrument design path, to control a specification of an accessory to the instrument design path and to control the rendering of the design of the base operating configuration of the flexible patient specific instrument (91) inclusive of the accessory.

7. The system of claim 1,

wherein the instrument design controller (80) is further operable, responsive to the delineation by the path planning controller (70) of the instrument design path, to control a specification of a tool relative to the instrument design path and to control the rendering of the design of the base operating configuration of the flexible patient specific instrument (91) inclusive of the tool.

8. The system of claim 1, further comprising:

a workstation, wherein at least one of the path planning controller (70) and the instrument design controller (80) is installed on the workstation.

9. The system of claim 1, further comprising: a diagnostic imaging system operable to generate the diagnostic scan of the anatomical structure.

10. The system of claim 9,

wherein at least one of the path planning controller (70) and the instrument design controller (80) is installed on the diagnostic imaging system.

11. The system of claim 1, further comprising:

an additive manufacturing device operable, responsive to a design by the instrument design controller (80) of the base operating configuration of the flexible patient specific instrument (91), to manufacture at least one of the flexible patient specific instrument (91) in the base operating configuration and a mold of the flexible patient specific instrument (91) in the base operating configuration.

12. The system of claim 1,

wherein at least one of the path planning controller (70) and the instrument design controller (80) is installed on the additive manufacturing device.

13. The system of claim 1, further comprising:

a subtractive manufacturing device operable, responsive to a design by the instrument design controller (80) of the base operating configuration of the flexible patient specific instrument (91), to manufacture at least one of the flexible patient specific instrument (91) in the base operating configuration and a mold of the flexible patient specific instrument (91) in the base operating configuration.

14. The system of claim 1,

wherein at least one of the path planning controller (70) and the instrument design controller (80) is installed on the subtractive manufacturing device.

15. A system for designing and manufacturing a base operating configuration of a flexible patient specific instrument (91) to follow an anatomical path relative to an anatomical structure, the system comprising:

a diagnostic imaging system operable to generate a diagnostic scan of the anatomical structure;

a workstation including a path planning controller (70) operable, responsive to a generation by the diagnostic imaging system of the diagnostic scan of the anatomical structure, to control a delineation of an instrument design path relative to the anatomical structure based on a scanned configuration of the anatomical path as illustrated in the diagnostic scan of the anatomical structure, and

an instrument design controller (80) operable, responsive to a delineation by the path planning controller (70) of the instrument design path, to control a rendering of a design of the base operating configuration of the flexible patient specific instrument (91) following at least a portion of the flexible patient specific instrument (91); and

at least of an additive manufacturing device and a subtractive manufacturing device operable, responsive to a design by the instrument design controller (80) of the base operating configuration of the flexible patient specific instrument (91), to manufacture at least one of the flexible patient specific instrument (91) in the base operating configuration and a mold of the flexible patient specific instrument (91) in the base operating configuration.

16. A method for designing and manufacturing a base operating configuration of a flexible patient specific instrument (91) to follow an anatomical path relative to an anatomical structure, the method comprising:

receiving a diagnostic scan of the anatomical structure;

delineating an instrument design path relative to the anatomical structure based on an scanned configuration of the anatomical path as illustrated in the diagnostic scan of the anatomical structure;

rendering a design of the base operating configuration of the flexible patient specific instrument (91) following at least a portion of the instrument design path; and

at least one of

additive manufacturing at least one of the flexible patient specific instrument (91) in the base operating configuration and a mold of the flexible patient specific instrument (91) in the base operating configuration; and

subtractive manufacturing the at least one of the flexible patient specific instrument (91) in the base operating configuration and the mold of the flexible patient specific instrument (91) in the base operating configuration.

17. The method of claim 16,

wherein the anatomical structure is tubular; wherein the anatomical path at least partially extends through the anatomical structure; and

wherein instrument design path is delineated along at least a portion of the least partial extension by the anatomical path through the anatomical structure as illustrated in the diagnostic scan of the anatomical structure.

18. The method of claim 16,

wherein the anatomical structure has a perimeter;

wherein instrument design path is delineated along at least a portion of the at least partially traversal by the anatomical path across the perimeter of the anatomical structure as illustrated in the diagnostic scan of the anatomical structure.

19. The system of claim 16, further comprising:

specifying an accessory to the instrument design path,

wherein the rendering of the design of the base operating configuration of the flexible patient specific instrument (91) inclusive of the accessory.

20. The system of claim 16, further comprising:

specifying a tool relative to the instrument design path,

wherein the rendering of the design of the base operating configuration of the flexible patient specific instrument (91) inclusive of the tool.