Patent ID: 12194251

While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

DETAILED DESCRIPTION OF THE DRAWINGS

Disclosed herein are devices, systems and methods for steering conventional guidewires or catheters during endovascular interventions and catheterizations. The proposed system can comprise an electromechanical steering device and a software graphical user interface (GUI) running on a computer. Further disclosed herein are devices, systems and methods directed to a minimally invasive medical imaging probe that also allows for positioning and tracking of an interventional device relative to the anatomy and reconstructed images. The proposed system can comprise an electromechanical steering device with an integrated transducer and sensor, and a software for rendering and visualizing the images as well as a GUI running on a computer for diagnosis, procedure planning, and navigation guidance. Further, disclosed herein are devices, systems and methods for steering and navigation of devices for cardiovascular interventions. The proposed system can comprise an electromechanical steering device, and a software for a GUI running on a computer for diagnosis, procedure planning, and navigation guidance.

FIG.1depicts a steering device100according to an embodiment. Steering device100may alternatively or additionally be referred to as an imaging probe. Further, steering device100may additionally be referred to as a steering mechanism at times in this disclosure.

In one embodiment, steering device100includes a handle110at proximal end102, a sheath122at least partially covering an internal catheter130, and an expandable structure112at a distal end104. In embodiments, handle110is configured to be held by the operator at proximal end102and further act as the controller portion of steering device100and/or steerable imaging probe. The expandable structure112at the distal end104is configured to enter a lumen of a body and is configured to be controlled by the operator via handle110.

FIGS.2and3show close-up views of the expandable structure112and distal end104of steering device100, according to an embodiment. In one embodiment, expandable structure112consists of a set or a plurality of expandable branches120(also alternatively referred to as expansible branches120). Branches120are mechanically biased to apply circumferential force and expand to a certain diameter. In an initial condition, branches120are mechanically constrained within a sheath122. When the branches120are extracted from the sheath122they expand within the vessel lumen and apply circumferential force towards a vessel wall (or cardiac chamber)123and may anchor and become relatively fixed with respect to the lumen, or chamber, once they have expanded (anchoring function). Once expanded, or fixated against a vessel wall or cardiac chamber, the tip of each one of these branches120acts as a mechanical leverage or anchor point124.

Although devices with a set of expandable branches as a type of expandable structure are primarily discussed in this disclosure, other sets of and forms of expandable structure are contemplated as well, including various expanding meshes, surfaces, components, projections or features. Further, anchor points124may be referred to as pivot points in this disclosure as well. These anchor points124each support a plurality of strings126that are connected to an eyelet128of an internal catheter130. Throughout this disclosure, references to “strings” should be understood to broadly refer to any type of strings, pull-wires, or similar manipulable components made of metal, fabrics, polymers, or crystals. In an initial condition, without any force exerted on strings126, eyelet128is concentric to sheath122and the vessel wall123.

Eyelet128is generally a structure having a ring-shaped perimeter and a central opening. Eyelet is generally surrounded by the expandable branches120and is supported around its ring-shaped perimeter by the distal end of strings126. Further, a guidewire or catheter132, passes through the internal catheter130and therefore may extend through the central opening and out from the eyelet128. It should be understood that guidewires132and catheters are examples of interventional devices that can be used with the steering devices100disclosed herein. Steering devices100can position such interventional devices within a vessel lumen or cardiac chamber of a patient, for example. The base of the branches120are connected to the internal catheter/tube130and they are all initially positioned within the sheath122. It is the motion of internal catheter130relative to sheath122that results in the extraction of branches120from sheath122and their expansion, or retraction of branches120into sheath122and their compression. In an embodiment, there are transmitters and, or, receivers that serve as sensors134integrated within the internal catheter130. The sensors134can be used to obtain measurements from the surrounding anatomy and particularly from the space in front of the sensor134.

In the embodiment inFIG.3, branches120of the expandable structure112at the distal end of the device are illustrated in an open and anchored position where they are pressing against the vessel wall123. The guidewire132passes through the lumen of the internal catheter130and through the eyelet128. Eyelet128is located in the center of the device and is steered by manipulation of strings126.

Branches120, as depicted inFIG.3, may be constructed by deforming and welding a rod (e.g. stainless steel or nitinol) to the desired shape using laser welding techniques. In an embodiment, branches120may be welded to a metallic cylinder, and embedded at the tip of an internal tube as depicted inFIG.3. Alternatively, branches120may be laser-cut from a tube of the desired material.

In general, by using the set of strings126, the eyelet128can be manipulated with two degrees of freedom and permit control of the position of the interventional device in a geometrically-defined area relative to a vessel lumen or cardiac chamber at a location of the set of expandable structures. In some embodiments, the eyelet128may be positioned in a plane perpendicular to the vessel lumen or cardiac chamber at a location of the expandible branches120. In some embodiments, the eyelet128may be positioned according to a surface shape or other geometry, such as a dome-shape.

FIGS.4to5Bdisclose a first embodiment of a handle110A and other components of a steering device100.FIGS.6and7disclose additional alternate embodiments of similar handles110B and110C of a steering device100. At times in this disclosure, any of these handles110A,110B and/or110C may be generically referred to individually or collectively as a handle110. Further, similar components in these handles110are referred to with the same reference numerals in some instances.FIGS.8-12Bprovide depictions of generally internal mechanisms for use with one or more of these handles110. The mechanisms should be viewed as being broadly contemplated and applicable to any of the handle arrangements or similar configurations to which they may apply or can be implemented.

FIG.4is a close-up view of handle110A of steering device100according to an embodiment. In embodiments, handle110A includes an opening140for the insertion of a catheter or guidewire132. Handle110A can include a top roller wheel142and a bottom roller wheel144that use a set of mechanisms to allow for steering of eyelet128. Top roller wheel142can be rotated along an axis perpendicular to the main axis of handle110A. Bottom roller wheel144rotates along an axis parallel to the main axis of the handle110A. A slide146is coupled to the internal catheter130and allows for the extraction or insertion of branches120. Slide146also has a locking mechanism achieved with a fastening screw148that allows locking of the position of internal catheter130relative to sheath122. The locking feature allows for controlling the extraction amount of branches120. In alternative embodiments, depending on the number of strings126that are manipulated, the number of rollers and corresponding mechanisms may vary.

FIG.5Adepicts an end view of handle110A of the steering device100.FIG.5Bdepicts a cross-section view of handle110A of steering device100viewed from section A-A ofFIG.5A. In the embodiment ofFIG.5A, top roller wheel142includes a boss159for coupling to a first string loop162. Top roller wheel142is also mechanically coupled to an encoder shaft164through another coupling mechanism166. Encoder shaft164is coupled to a magnet holder168that is configured to hold magnet171of magnetic encoder sensor173at a fixed distance from magnetic encoder sensor173. A tensioning mechanism175, which includes a spring, may be used to maintain tension on first string loop162. In other embodiments of the mechanism coupling string126to top roller wheel142, tensioning and sensing methods may vary.

In embodiments, bottom roller wheel144has an extension boss181for coupling to a second string loop182. Bottom roller wheel144is also mechanically coupled to another encoder magnet holder184. Magnet holder184is positioned to hold magnet186of a magnetic encoder sensor188at a fixed distance from magnetic encoder sensor188. A tensioning mechanism191, including a spring may be used to maintain tension on second string loop182. In other embodiments of the mechanism coupling string126to bottom roller wheel144, tensioning and sensing methods may vary.

In embodiments, slide146and tensioning screw148allow for extraction and withdrawal of internal catheter130within the sheath122. Slide146is extended and has an opening193which couples to internal catheter130. Slide146can travel along a slit opening195in the handle body.

In an embodiment, handle110A also houses a circuit board197, that contains all the necessary electronics and embedded systems to capture the position of the encoders and transmit that information to a host computer through a port198(e.g. USB) or wirelessly.

FIG.6is a close-up view of handle110B of steering device100according to an embodiment. In embodiments, handle110B comprises a sealing valve141for the insertion of a catheter or guidewire132. Handle110B can include a top roller wheel142and a bottom roller wheel144that use a set of mechanisms to allow for steering of eyelet128or internal catheter130. Top roller wheel142can be rotated along an axis perpendicular to the main axis of handle110B. Bottom roller wheel144rotates along an axis parallel to the main axis of the handle110B. A slide146is coupled to the internal catheter130and allows for the extraction or retraction of branches120. In an embodiment, slide146also has a locking mechanism achieved with a fastening screw148that allows locking of internal catheter130position relative to sheath122. The locking feature allows for controlling the extraction range of the branches120. A knob149allows for applying tension on strings connected to the tip of the outer sheath122. With different indentation hardness along the length of the sheath, the tension on the strings, created by rotation of the knob, leads to deflection of the softer distal segment of the sheath. In alternative embodiments, depending on the number of strings126that are manipulated, the number of rollers and corresponding mechanisms may vary.

In an alternative embodiment, shown inFIG.7, a handle110C has a slide146for advancing the internal catheter130and allows for extraction or retraction of branches120. Handle110C further includes a steering mechanism160.

FIGS.8A and8Bshow the slide146from multiple perspectives. A slide146similar to this could be used with handle110C or variations of the other handle100designs. This slide146allows for extracting or retracting of the internal catheter130and the branches120within the sheath122. In an embodiment, the slide146of the handle110, uses two opposing surfaces150that are gripped by the user. An extension152of the opposing surfaces150are pressed against a surface154by use of springs158inside the cavity156within the handle110. The application of force from the springs158, creates friction between two surfaces152and154and prevents the slide146from moving. The user can adjust the extraction of the internal catheter130by pushing on the opposing surfaces150to relieve the friction between the two surfaces152and154and allow moving the slide146and therefore extracting or retracting the internal catheter130.

In one embodiment, the handle110utilizes a steering mechanism160to allow for deflecting the distal end of the outer sheath122as shown inFIG.9AandFIG.9B. A steering mechanism160similar to this could be used with handle110C or variations of the other handle100designs. As is illustrated, the steering mechanism160utilizes a rotary dial170connected to a spiral gear172. The spiral gear172engages with a nut174that is constrained with two guide rails176to travel axially as the nut174and spiral gear172engage. A string178which connects to one end of the distal end of the sheath122is connected to the nut174. Travel of the nut175allows for creating tension on the string178and allows for deflecting the distal end of the sheath122. In an embodiment, the sheath122may have two strings on opposite sides of the sheath122to allow for bi-directional steering.

In an embodiment, the second string180may be connected as illustrated inFIG.9Band initially during assembly of the catheter handle110the second string180can be tensioned such that the distal end of the sheath122is biased in the direction of the corresponding guidewire. This permits bi-directional steering by relaxing or applying tension on the first string178through actuation of the rotary dial170and the travel of nut174.

FIG.10demonstrates an embodiment of the internal mechanism within a handle110that can be used for pulling on the strings126and sensing their position. Typically, two sets of such a mechanism would be inside the device handle110and would allow the user to manipulate the internal catheter130and the eyelet128with two degrees of freedom. In the embodiment depicted inFIG.10, the free ends of strings126are connected to gears192and during assembly, the gears192can be rotated to allow for tensioning of the strings126to a desired level. A spring or other tensioning mechanism could also be used to apply further tension on the strings126. The central gear194is mechanically coupled to the wheels142or144to be manipulated by the user. The gear196is coupled to the previous gears and is connected to a position sensor such as an encoder wheel to permit sensing the actuation of the strings126. This design facilitates the assembly of the device and allows for the assembler to tension the strings126as desired before placing the other gears194and196which would fixate the relative position of gears192and maintain the set tension on strings126.

FIGS.11A-Cshow an alternative embodiment of the internal mechanism200for manipulation of the strings126and sensing their position. This embodiment utilizes a spring mechanism202to tension the strings126as desired during the assembly process. The strings126are coupled to the tensioning mechanism202through roller wheels204. The roller wheels204are pushed outward for tensioning by an array of springs208. The strings126are also connected to a main roller206that is mechanically coupled to the roller wheel142or144actuated by the user.

An embodiment having an arrangement of two such internal mechanisms200for controlling two independent strings126is shown inFIGS.12A and12B.

In some embodiments, handle110also houses a circuit board, that contains all the necessary electronics and embedded systems to capture the position of the encoders and transmit that information to a host computer through a port (e.g. USB) or wirelessly.

FIG.13Adepicts a system250for steering a catheter or guidewire132according to an embodiment. As indicated, a user, such as an interventionalist252, can manipulate the catheter or guidewire132with seven DOF. The user can push/pull and rotate (two DOF) the guidewire by manipulating it remotely from the section outside the catheter handle110. The outer sheath122that supports the catheter can be manipulated itself with three DOF (Push/Pull, rotation and deflection of distal end) and the two extra DOFs are provided by the steering mechanism of the expandable structure112as described previously. The latter two DOF, i.e., up/down and left/right, can be manipulated by the user with the aid of a user interface254which displays position data of the guidewire132or catheter tip.

FIGS.13B-13Care flowcharts260and270, respectively, of a program which can run on an embedded system in the device100and on a host computer. According toFIG.13B, the code for the embedded system on the device100(e.g. a microcontroller-based circuit), is primarily in charge of measuring the encoder values and transmitting them to a host computer. According toFIG.13C, the host computer software is in charge of visualizing the position of the device100relative to a virtual vessel. The position of the guidewire132is captured in real-time and overlaid on the virtual vessel map and visualized for the user.

Flow chart260generally consists of steps with respect to the device100. It includes initializing parameters at step262, followed by performing calibration at264, then tracking position(s) at266, and transmitting the position(s) to the host at268. The method cycles back to tracking further positions at266.

Flow chart270generally consists of steps with respect to a host computer. It includes initializing parameters at step272, followed by visualizing the vessel, current position, and recorded positions at step274. This may include a medical image overlay of the patient. Next, at276the host receives position data from the device100, followed by overlaying tip position on the visualization at278, and finally an inquiry as to whether there is a request for a position recording at280. If no request is made at280, the method returns to step274. If a request is made at280, the host records the position at282before cycling back to step274.

In embodiments, the user recorded positions can also be captured and visualized for the user (e.g. with different colors). Further, the user recorded positions can indicate the positions that the guidewire has been previously to indicate previous locations of interest. In some embodiments, the virtual vessel map may be augmented by an overlay of registered patient data, that may be obtained during or prior to a procedure. For example, such images may be acquired using Magnetic Resonance Imaging or X-ray computed Tomography and registered and overlaid on the virtual map based on the corresponding position of the device's distal end within the patient anatomy.

FIGS.14A and14Bdepict an example of a virtual vessel map displayed on a graphical user interface. In embodiments, a circle290represents the vessel lumen. A square292represents the workspace of the steering device and corners294of the square represent the anchor points of branches120. A dark dot296represents the current position of the tip or eyelet128. Dark dot296can be continuously updated in real time. A plurality of lighter dots298represent the previous positions of the tip or eyelet128that have been recorded. A medical image (e.g. MRI) overlay299on the visual interface is depicted inFIG.14B. In this example image, the dark locations on the image are the openings within an occlusion which is the hypothetical target for guidewire tip navigation. In an embodiment, the display may be mounted directly on handle110(e.g., LCD or LED screen) or may comprise a number of discrete light-emitting diodes arranged to represent the device's workspace and with different colors of LEDs being used to represent the previous and current positions of the device.

FIG.15depicts an example of a graphical user interface300. In embodiments, a circular shape310virtually represents the vessel lumen. A rectangle312represents the workspace of the steering device100and corners of the rectangle represent the anchor points124of the branches. A star314represents the current position of the tip or eyelet128which is updated in real-time. The arcs318represent the length of the strings that have been tracked and their intersection estimates the current position of the eyelet128that is represented by314. Dark dots316represent the previous locations of interest that have been recorded by the user.

FIGS.16A,16B and16Ccollectively depict the concept for utilizing the proposed device for the purpose of imaging. In an embodiment, eyelet128containing the sensor134and/or transmitter can be moved to a different location320and at each location a transmission, such as an ultrasound burst of signal322, can be transmitted and reflected from a target tissue of interest324. The reflected signal325can then be picked up by the sensor134. By moving the eyelet128containing the sensor/transmitter to different locations, such as320, a desired area of interest can be scanned, and measurements can be obtained for the purpose of reconstructing an image such as 3D ultrasound image. As shown in these figures, transmitter signals are noted as T11-Tmn and represent transmitter signals at various arrayed locations. Likewise, reflected signals shown in these figures are noted as R11-Rmn and represent reflected signals at various corresponding arrayed locations as well.

In an embodiment, as depicted inFIGS.17A,17B, and17C, an independent device may be inserted into the internal catheter130. This device may be equipped with a transceiver or sensor330. In an embodiment, this sensor330may be a force sensor and may be used to apply a known mechanical excitation to the tissue of interest to obtain a mechanical response that can be measured with the sensor330. By scanning and moving the eyelet128, and therefore the sensor330to different locations, a desired area of interest can be scanned, and measurements can be obtained for imaging (e.g. elastography). As shown in these figures, the known mechanical excitation is noted as V11, and likewise, indications F11-Fmn denote mechanical responses at various arrayed locations.

FIGS.18A and18Bdescribe flowchart400A and400B of a program which can run on an embedded system in the device and on a host computer. According toFIG.18A, the known positions of the device can be used to cover and obtain measurements from a complete surface of interest. In an embodiment, the position of the device can be moved by the user manually or alternatively automatically by actuators coupled to the mechanisms within the handle110.FIG.18Bdescribes a flowchart of a software that can be run on the embedded system in the device and on the host computer. The software describes how the device's known position together with potentially other measurements, such as measurements from sensors134at the tip of the device and/or a sensor tracking the insertion length of a desired device of interest, such as a guidewire132, within the internal catheter130can be used to provide a virtual 3D visualization of the tip of the guidewire132relative to the branches124and within the device's workspace. Such information may be overlaid on images constructed based on methods described previously and in the flowchart ofFIG.18A.

Flowchart400A generally consists of calibration and initialization (n=1) at402, followed by moving the tip (containing a sensor) to a position (xn, yn) at404. The next step406relates to acquiring a measurement with a sensor at (xn, yn). Next at408the system checks whether the entire surface is covered. If not, the method cycles to step404. If yes, the method proceeds to reconstructing the map based on all n measurements at410.

Flowchart400B generally consists of rendering and loading the reconstructed map or registered image at412followed by measuring the inner catheter's (x, y) position at414. Next at416is measuring axial insertion of the device100within the inner catheter, if available. Finally, at418is overlaying the virtual rendered device image on the map or registered image based on (x, y, z) measurements.

Accordingly, methods for positioning and tracking a device100within a vessel lumen or cardiac chamber of a patient can be understood. Some methods required providing an electromechanical steering device system that guides the guidewire132or interventional device. A electromechanical steering device system can include: a catheter132with expandable branches120and a eyelet128at its distal tip that is controlled by a set of strings126actuated by a handle110. The system may also include a plurality of sensors attached to one or more of: the interventional device, the catheter132, and the set of strings126; and a computing device communicatively coupled with the plurality of sensors. A computing device can include: at least one processor and memory operably coupled to the at least one processor and configured to store instructions invoked by the at least one processor and a positioning and tracking engine configured for tracking interventional device position and communications for rendering and visualization of images; and a GUI display communicatively coupled with the computing device. Methods can includes moving a tip of an interventional device to a desired position(s) by actuating the handle110. The methods can include acquiring measurements from the plurality of sensors at the desired position(s). Methods can further include reconstructing a map of the vessel lumen or cardiac chamber of interest based on the acquired measurements. Methods also can include rendering and loading a virtual rendered device image using the position and tracking engine. Methods can also include measuring the catheter position from the plurality of sensors and measuring the axial insertion of the interventional device within the catheter from the plurality of sensors. Finally, some methods further include overlaying the virtual rendered device image on the map based on the measurements in an overlaid image presented on the GUI display.

FIG.19Adepicts the expandable structure positioned inside a stent graft420that is deployed within an abdominal aortic aneurysm422and suggests how the device may be used as part of the treatment procedure. Using the steering device100, the guidewire132can be navigated for the purposes of navigating towards the branches or openings of the stent424to connect the main stent420to the branched arteries such as the renal arteries426for gate cannulation purposes.

FIG.19Adepicts the expandable structured positioned inside a stent graft420that is deployed within an abdominal aortic aneurysm422and suggests how the device may be used as part of the treatment procedure. Using the steering device100, the guidewire132can be navigated for the purposes of navigating towards the branches or openings of the stent424to connect the main stent420to the branched arteries such as the renal arteries426for gate cannulation purposes.

FIG.19Bsuggests an alternative application of the steering device100and possible position of deployment for the purposes of gate cannulation as part of an endovascular abdominal aortic aneurysm repair procedure. In this setup, the expandable structure112is positioned close to the opening of the superior femoral artery430and is used to navigate the guidewire132to the purposes of gate cannulation.

FIG.20illustrates an alternative embodiment for the expandable structure112. As shown, the structure can be formed constructed such that when it is advanced out of the sheath122or deployed, it orients itself in a specific direction that may facilitate the specific intervention, such as gate cannulation for EVAR procedures.

FIG.21illustrates the expandable structure112positioned within the aorta for facilitating the navigation of a guidewire/catheter for crossing the aortic valve440and suggests an application as part of transcatheter aortic valve implantation.

FIG.22Ashows the expandable structure112positioned in the left atrium for the purposes of navigating a guidewire or catheter as part of mitral valve442implantation procedure or for the purposes of performing a catheterization procedure in left ventricle444.

FIG.22Bshows the expandable structure112positioned in the left atrium. As an example, in cardiac catheterization procedure for the treatment of atrial fibrillation, the steering device may be used to position, track and navigate an ablation catheter446at the desired target locations.

FIG.23depicts the expandable structure112deployed in the right atrium for the purposes of navigation of a needle450for accurate and reliable interatrial membrane452transseptal puncture.

FIG.24depicts an alternative embodiment for the expandable structure112where a mesh like structure is used for expansion and support of the strings126to permit the steering and navigation of the internal catheter and its eyelet128or tip.

FIG.25depicts a sideview of an alternative embodiment for the expandable structure112. As it is illustrated in this embodiment, a balloon462may be connected to internal catheter130. The channels for the balloon462may run along the length of internal catheter130. The balloon462may be inflated, and their inflation will apply pressure onto the expandable structure or the branches120according to an embodiment. This mechanism may be used to expand the self-expanding structure, when it is not able to do it on itself relying only on the material mechanical properties.

In an alternative embodiment, two sets of steering mechanisms can be used at different positions along the length of the device to allow for bending of the guidewire as well as its positioning. In such an embodiment, a second steering mechanism, similar to the one shown inFIGS.2and3, could be integrated into the device at a fixed, or variable, offset from the first steering mechanism. By controlling each steering mechanism independently and depending on the distance between the two eyelets where the guidewire passes, the bending of the guidewire and its position may be controlled simultaneously.

In yet another alternative embodiment, an imaging device, such as an ultrasonic transducer could be connected to the steered section of eyelet128to allow for tracking the position of the imaging device for volumetric image reconstructions (e.g. 2D ultrasound from 1 ultrasound transducer). In another embodiment, an imaging probe, such as an array of ultrasonic transducers, or optical imaging devices, can be connected to the sheath or branches120, to allow for imaging the anatomy, simultaneously to guidewire or catheter navigation and tracking.

In yet another alternative embodiment, various imaging sensors, or combinations thereof, such as an optical sensor, ultrasound sensor/transducer, a radioactivity detector, scintillator, photomultiplier, radiofrequency antenna, with a collimator or filter or combination thereof may be used as a sensor134. In another embodiment, a laser source may be positioned within the internal catheter130to provide means of delivering therapy at known desired targets based on obtained tracking information with or without image information obtained with the device.

In other embodiments, the actuation method for steering may be electromagnetic instead of mechanical (i.e. strings126). In such an embodiment, an electric field or magnetic field generator (e.g. coil) may be connected to the branches120or to eyelet128to generate relative force between the branches and the steered opening to allow for positioning of the eyelet relative to the branches. In an alternative embodiment, the strings may be replaced with nitinol wire which may be expanded and retracted using electric current to control the position of the eyelet128.

In an embodiment, the sheath122would be steerable and another string connected to the tip of sheath122would be actuated (i.e. pulled) in the handle to allow for another degree of freedom in steering and navigation of sheath122.

In alternative embodiments, there may be one, two, or three strings126that are used for steering the internal catheter130.

In an alternative embodiment, a balloon may be integrated into the internal catheter and it may be inflated and used to anchor the internal catheter130relative to the anatomy as desired.

In an embodiment the wheels142,144on the device handle110can be pressed, or clicked by the user to allow interaction with the graphical user interface for applications such as recording the current position of interest.

Devices, systems and methods described herein can be used in various applications. For example, the described system can be used for navigation of guidewires for angioplasty procedures. In one application, the above system can be used for navigation of guidewires in EVAR or transcatheter aortic valve implantation (TAVI). In one application, the above system can be used for navigation of catheters in catheterization procedures (e.g. cardiac ablation or cryoablation, or lead placement) or for positioning needles for trans-septal puncture in cardiac catheterization procedures. In yet another example, the above system can be used to manipulate and navigate a drug delivery catheter (e.g. injection needle) for targeted delivery of drugs or stems cells in cardiac therapy in a systematic and controllable approach. In yet another example, the proposed systems and methods can be used for biopsy or delivery of therapy for applications in oncology (e.g. lung biopsy or colonoscopy).

Devices, systems, and methods disclosed herein provide catheter and guidewire steering capability without modification of the guidewires or catheters. The proposed approach also allows for accurately tracking the position of the guidewire, or catheter, and therefore allows for its visualization with respect to the vessel lumen, or cardiac chamber. This invention allows for accurate 5-DOF continuous position control of the guidewire or catheter. This novel approach provides two extra DOF in motion control relative to conventional guidewire or catheter manipulation techniques together with unique features that permit accurate local position control and tracking ability as well as support and anchoring.

In embodiments, the devices disclosed herein and/or their components or systems include computing devices, microprocessors and other computer or computing devices, which can be any programmable device that accepts digital data as input, is configured to process the input according to instructions or algorithms, and provides results as outputs. In an embodiment, computing and other such devices discussed herein can be, comprise, contain or be coupled to a central processing unit (CPU) configured to carry out the instructions of a computer program. Computing and other such devices discussed herein are therefore configured to perform basic arithmetical, logical, and input/output operations.

Computing and other devices discussed herein can include memory. Memory can comprise volatile or non-volatile memory as required by the coupled computing device or processor to not only provide space to execute the instructions or algorithms, but to provide the space to store the instructions themselves. In embodiments, volatile memory can include random access memory (RAM), dynamic random access memory (DRAM), or static random access memory (SRAM), for example. In embodiments, non-volatile memory can include read-only memory, flash memory, ferroelectric RAM, hard disk, floppy disk, magnetic tape, or optical disc storage, for example. The foregoing lists in no way limit the type of memory that can be used, as these embodiments are given only by way of example and are not intended to limit the scope of the invention.

In embodiments, the system or components thereof can comprise or include various engines, each of which is constructed, programmed, configured, or otherwise adapted, to autonomously carry out a function or set of functions. The term “engine” as used herein is defined as a real-world device, component, or arrangement of components implemented using hardware, such as by an application specific integrated circuit (ASIC) or field-programmable gate array (FPGA), for example, or as a combination of hardware and software, such as by a microprocessor system and a set of program instructions that adapt the engine to implement the particular functionality, which (while being executed) transform the microprocessor system into a special-purpose device. An engine can also be implemented as a combination of the two, with certain functions facilitated by hardware alone, and other functions facilitated by a combination of hardware and software. In certain implementations, at least a portion, and in some cases, all, of an engine can be executed on the processor(s) of one or more computing platforms that are made up of hardware (e.g., one or more processors, data storage devices such as memory or drive storage, input/output facilities such as network interface devices, video devices, keyboard, mouse or touchscreen devices, etc.) that execute an operating system, system programs, and application programs, while also implementing the engine using multitasking, multithreading, distributed (e.g., cluster, peer-peer, cloud, etc.) processing where appropriate, or other such techniques. Accordingly, each engine can be realized in a variety of physically realizable configurations, and should generally not be limited to any particular implementation exemplified herein, unless such limitations are expressly called out. In addition, an engine can itself be composed of more than one sub-engines, each of which can be regarded as an engine in its own right. Moreover, in the embodiments described herein, each of the various engines corresponds to a defined autonomous functionality; however, it should be understood that in other contemplated embodiments, each functionality can be distributed to more than one engine. Likewise, in other contemplated embodiments, multiple defined functionalities may be implemented by a single engine that performs those multiple functions, possibly alongside other functions, or distributed differently among a set of engines than specifically illustrated in the examples herein.

Various embodiments of systems, devices, and methods have been described herein. These embodiments are given only by way of example and are not intended to limit the scope of the claimed inventions. It should be appreciated, moreover, that the various features of the embodiments that have been described may be combined in various ways to produce numerous additional embodiments. Moreover, while various materials, dimensions, shapes, configurations and locations, etc. have been described for use with disclosed embodiments, others besides those disclosed may be utilized without exceeding the scope of the claimed inventions.

Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. § 112(f) are not to be invoked unless the specific terms “means for” or “step for” are recited in a claim.