CN116669804A - Double-hinged catheter - Google Patents

Abstract

An articulating catheter defines a first bend at a distal portion of the catheter and a second bend proximal to the first bend.

Description

Double-hinged catheter

Background

Technical Field

The present disclosure relates to the field of navigation catheters, and in particular to navigation catheters capable of dual articulation and user defined curvature to facilitate navigation and target acquisition.

Description of related Art

There are several commonly used medical procedures, such as endoscopic or minimally invasive procedures, for treating various diseases affecting organs, including liver, brain, heart, lung, gall bladder, kidney and bone. Typically, a clinician employs one or more imaging modalities such as Magnetic Resonance Imaging (MRI), ultrasound imaging, computed Tomography (CT), or fluoroscopy, to identify and navigate to a region of interest and a final target for biopsy or treatment within a patient. In some procedures, pre-operative scanning may be utilized for target identification and intra-operative guidance. However, real-time imaging may be required to obtain a more accurate and current image of the target region. Furthermore, it may be desirable to display the current position of the medical device relative to the target and real-time image data of its surroundings to navigate the medical device to the target in a safe and accurate manner (e.g., without causing damage to other organs or tissues).

For example, endoscopic methods have proven to be useful in navigating to a region of interest within a patient's body, and in particular for regions within a body's luminal network (such as the lungs). To implement endoscopic methods and more particularly bronchoscopic methods in the lungs, intrabronchial navigation systems have been developed that use previously acquired MRI data or CT image data to generate three-dimensional (3D) renderings, models or volumes of specific body parts, such as the lungs.

The resulting volume generated from the MRI scan or CT scan may be utilized to create a navigation plan to facilitate advancement of a navigation catheter (or other suitable medical device) through a bronchoscope and branches of a patient's bronchi to a region of interest. A positioning or tracking system, such as an Electromagnetic (EM) tracking system, may be used in conjunction with, for example, CT data to facilitate guiding a navigation catheter through a branch of the bronchi to a region of interest. In some cases, the navigation catheter may be positioned within one of the airways adjacent to or within the region of interest of the branched cavity network to provide access to one or more medical devices.

Accurate placement of the catheter is important to ensure that tools such as biopsy and treatment tools interact with the desired tissue. Improvements to current navigation catheter systems are desired.

Disclosure of Invention

One aspect of the present disclosure relates to:

drawings

Various aspects and embodiments of the disclosure are described below with reference to the drawings, in which:

FIGS. 1A-1C depict a distal portion of a catheter having a preformed curvature;

fig. 2A-2C depict a distal portion of a catheter having a variable curvature according to the present disclosure;

FIG. 3 depicts an articulating mechanism for incorporation into a catheter according to the present disclosure;

fig. 4 depicts a distal portion of a catheter with an alternative articulation mechanism in accordance with the present disclosure;

FIG. 5 depicts a drive mechanism for acting on one or more wires in accordance with the present disclosure;

FIG. 6 depicts an alternative drive mechanism for acting on one or more pull wires in accordance with the present disclosure;

FIG. 7 depicts other alternatives for applying one or more pull wires according to the present disclosure;

FIG. 8 depicts an intracavity navigation system according to the present disclosure;

fig. 9 depicts a schematic of a workstation for use with an intra-cavity navigation system in accordance with the present disclosure.

Detailed Description

The present disclosure relates to an articulating catheter for navigation of a luminal network (such as the airways of the lung). The articulation, in particular the two-point articulation, allows the user to ensure the orientation of the distal portion of the catheter in the desired direction. Such an orientation may be particularly useful when tools such as biopsy and treatment tools (e.g., microwave ablation catheters) are passed through the catheter to diagnose or treat the desired tissue. The use of two hinge points allows for a vigorous manipulation of the distal portion of the catheter and a milder articulation of the more proximal portion of the catheter. In combination, the dual articulation mechanism allows the catheter to assume a variety of curvatures and shapes to improve positioning of the catheter. To reduce the complexity of the design, a two-point articulation system may be implemented using only a single guidewire.

The catheter typically has a fixed or adjustable curvature at the distal tip. The center of curvature is typically 2-4 cm posterior to the distal tip and has a radius of curvature of 1-2 cm. This curvature is used to aid in endoluminal navigation by pointing the distal tip towards the lumen branch. The user rotates the catheter to align the tip with the desired branch and then advances the catheter into the branch.

Fig. 1A-1C depict versions of a generic curved catheter 10 for navigating within an airway of a patient. Catheter 10 has a 45 ° bend in fig. 1A, a 90 ° bend in fig. 1B, and a 180 ° bend at the distal portion of catheter 10 in fig. 1C. Different amounts of curvature of the catheter may be used to navigate to different portions of the patient's airway. For example, a catheter comprising a 180 ° bend may be used to navigate to the rear of the upper lobe of the patient's airway. In practice, through the rotation and pushing process, the clinician may manipulate the bend in catheter 10 so that it is directed to the desired lumen in the airway. Once so oriented, pushing or advancing the catheter ensures access to the desired airway. This process may be repeated multiple times to follow a path plan described in more detail below to a desired location in the airway.

While such a wide curvature is useful for lumen navigation, it does not help direct the distal tip away from the general axis of the catheter. This is especially true in smaller chambers where the walls of the chamber resist a wide curvature. In such cases, a sharper device articulating the distal tip provides the desired change of direction. The articulation is typically within the first 0.5-1 cm of the distal tip and has a sharp articulation of 5-30 degrees. This smaller articulation is also useful in combination with a wider curvature during navigation.

There are two additional aspects of pre-curved catheter 10 that can be challenging. First, the clinician must decide which catheter 10 to use throughout the procedure, and once selected, must use the catheter 10 throughout the procedure. Second, in the last few centimeters of navigation, the curvature that aids in navigation at this point makes it challenging to align the opening in catheter 10 with the target. Rotation of the curved catheter 10 causes the distal end and the opening formed therein to rotate in an arc about the target, rather than changing the alignment to conform to the target.

It is possible to construct a catheter combining both types of articulation. A pull wire embodiment using one or a pair of pull wires for an articulation joint may be employed. The wires are hinged substantially in a single plane. A curvature similar to that shown in fig. 2A to 2C is achieved in the articulating catheter and improved alignment characteristics are achieved.

Fig. 2A-2C depict a catheter 20 having two hinge points according to the present disclosure. Catheter 20 includes a catheter tube 22. A pull wire lumen 24 is formed in the catheter tube 22 for allowing a pull wire 26 to pass therethrough. Also formed in the catheter tube 22 are a first pull ring 28 and a second pull ring 30, to which the pull wire 26 is permanently secured (e.g., by welding, gluing, or other means). The second tab 30 includes an aperture 32 through which the pull wire 26 passes. A stopper 34 is formed on the wire 26. When the pull wire 26 is pulled proximally, the pull wire 26 acts on the first pull ring 28. The result of this initial translation of pull wire 26 proximally (e.g., toward the user) is a change in the shape of distal-most portion D2 of catheter 20, as seen in fig. 2B. The pull wire 26 translates through the aperture 32 in the second pull ring 30, but does not change the shape of the catheter 20 at the second pull ring 30. Further retraction of the pull wire 26 causes the stop 34 to reach the aperture 32, but because it is sized not to pass through the aperture 32. Once the stop 34 is secured in the aperture 32, tensioning the pull wire 26 causes the catheter tube 22 to flex and create a second bend at the second pull ring 30, as seen in FIG. 2C. The spacing between the position of the stop 34 and the point at which the stop 34 is received in the aperture 32 when the catheter 20 is straight (fig. 2A) defines a delay between the onset of articulation of the distal portion D2 and the onset of articulation of the more proximal portion D1.

In one embodiment, the conduit 22 may be formed of a material having a uniform hardness level along the entire length. However, the catheter tube 22 may have different stiffness in regions D1 and D2 to allow for different amounts of articulation of the catheter 20. In some embodiments, the proximal portion D1 may be formed from a material having a shore a hardness ranging from about 30 to about 80. The distal portion D2 may be formed of a material having a shore a hardness scale of from about 30 to about 63. As will be appreciated, other ranges may also be employed without departing from the scope of the present disclosure. In other embodiments, stop 34 may be eliminated and two bends may be achieved by virtue of the difference in stiffness between distal portion D2 and distal portion D1.

The difference in material selection may result in catheter 20 having memory. That is, when the tension on the pull wire 26 is released, the catheter 20 has a tendency to return to its un-articulated shape (e.g., straight as depicted in fig. 2A). Additionally or alternatively, the pull wire 26 may be formed from a material (e.g., nitinol) that has a tendency to return to its unstressed state. Still further, the pull wire may be selected from materials having sufficient column strength to allow the pull wire 26 to push the catheter 20 back to its un-articulated position.

Fig. 3 depicts a perspective view of the actuation mechanism of catheter 20 with catheter tube 22 removed to more clearly depict the interaction of these components. The stop 34 may be adhered to the pull wire 26 via an adhesive, swaged to the pull wire 26, knotted to the pull wire 26, or welded to the pull wire 26. Additionally or alternatively, the stop 34 may have a profile that is substantially different from the profile of the aperture 32. For example, the stop 34 may be rectangular or cross-shaped, while the aperture 32 is substantially circular.

Those skilled in the art will recognize that the actuation mechanism may be disposed on the proximal end of the catheter 20. Some motorized actuation mechanisms are described in more detail herein below in connection with a dual wire system, and may also be deployed in the single wire system of fig. 2A-2C. Further, the actuation mechanism may be a manual actuation mechanism (such as a lever system mounted on the proximal portion of the catheter 20) and configured to act on the pull wire 26 to retract the pull wire in a proximal direction to achieve a curvature of the catheter 20.

An alternative embodiment of the present disclosure can be seen in fig. 4. While the single pull wire embodiment shown in fig. 2A-3 is beneficial, a dual pull wire system may also be employed. As shown in fig. 4, a catheter 40 having a catheter tube 22 and two pull rings 28 and 30 is depicted. Catheter 40 includes two pull wire lumens 24A and 24B. Extending in the first wire cavity 24A is a wire 26A permanently attached to the second tab 30. Within the second wire lumen 24B is a second wire 26B that is permanently attached to the first pull ring 28. In such a configuration, the first pull wire 26A or the second pull wire 26B may be retracted or pulled proximally to achieve a desired curvature or double curvature of the catheter 40. The pull wires 26A and 26B should be separated by a distance L that is as small as practical so that the forces applied by the pull wires 26A and 26B to the catheter tube 22 are substantially aligned to achieve the desired curvature.

Fig. 5 depicts an exemplary actuation mechanism for the embodiment of fig. 4 that employs two pull wires 26A and 26B. As shown in fig. 5, the shuttle 50 rides on a lead screw 52. The lead screw 52 may be driven by a motor 54. As the lead screw 52 rotates, the shuttle 50, which has threads that mate with the lead screw 52, advances in the direction of the distal end of the catheter or retracts toward the motor 54. When shuttle 50 is retracted in the direction of motor 54, pull wire 26B permanently attached to pull ring 28 at the distal end of catheter 40 and permanently attached to shuttle 50 causes the distal portion of the catheter to bend to a position similar to that shown in fig. 2B. The pull wire 26A attached to the pull ring 30 is slidingly engaged in a cavity 56 formed in the shuttle 50. Further retraction of the shuttle in the direction of the motor 54 causes a stop 58 formed on the proximal end of the pull wire 26A to abut the lumen 56, but the stop 58 is sized or shaped to prevent it from passing through the lumen 56. Further retraction of the shuttle causes the catheter 40 to assume a shape similar to that depicted in fig. 2C. In this way, the shuttle 50 acting on the two pull wires 26A and 26B enables the catheter to bend in a similar manner to the single pull wire system shown in fig. 2A-3.

One of ordinary skill in the art will recognize that the shuttle 50, lead screw 52, and motor 54 may also be used on the proximal end of the catheter 20. But the shuttle 50 will have only a single pull wire 26 permanently attached to the shuttle. Retraction of the shuttle 50 then causes the shape of fig. 2A-2C to change because retraction of the pull wire 26 acts first on the first pull ring 28 and then on the second pull ring 30 when the stopper 34 engages the aperture 32 as described above.

As depicted in fig. 6, two pulleys or wheels 60 may be used to employ other alternative embodiments using a dual pull wire system. Pulley 60 may be motor driven and mounted in a housing. In one embodiment, the pulleys 60 are of different sizes. Rotation of the different sized pulleys 60 results in different retraction rates of the pull wire and thus different articulation rates. Alternatively, the pulleys may be the same size but engaged at different times to act on the tab 28 or the tab 30 at different times.

An alternative embodiment can be seen in fig. 7, which uses a single motor 54 coupled to a pulley 60 via a shaft 62. Pulley 62 includes a cam 64. The second pulley 63 is not driven by the motor 54 but may also ride on the shaft 62. After the pulley 62 rotates a certain amount, the cam 64 acts on a similar cam 66 on the second pulley 63. The second pulley 63 is driven only by the interaction of the cam 64 acting on the cam 66. As a result, the first pulley 60 begins to rotate before the cam 64 can act on the cam 66 to begin rotation of the second pulley 63. This delay in retraction of the pull wire 26A, as compared to immediate retraction of the pull wire 26B, achieves a similar articulation as the embodiment described in connection with fig. 5.

The catheter 20, 40 may be used in a portion of a system for in vivo navigation of a luminal network (e.g., a patient's lungs). In accordance with the present disclosure, a 3D volume of another suitable portion of a patient's lungs or anatomy may be generated from a previously acquired scan, such as a CT scan. These scans may be used to generate a 3D model of the anatomy. The 3D model and related scan data are used to identify a target, e.g., a potential lesion for biopsy or treatment, and to generate a path plan through the anatomy to reach the target.

Once the path plan is generated and accepted by the clinician, the navigation system can utilize the path plan to drive the catheter 20, 40 through the anatomy along the path plan to reach the desired target. The driving of the catheter 20, 40 along the path plan may be manual, or it may be robotic, or a combination of both. The manual system comprises an illumite navigation system sold by Medtronic PLC (Medtronic PLC), and the robotic system comprises an ION system sold by intuitive surgery company (Intuitive Surgical inc.) and a MONARCH system sold by Auris Health, inc. In a single program plan, registration of the path plan with the patient and navigation are performed to enable the medical device (e.g., catheter 20, 40) to be navigated along the planned path to reach the target (e.g., lesion) so that a biopsy or treatment of the target may be completed.

Fig. 8 is a perspective view of an exemplary system for facilitating navigation of a medical device (e.g., catheter 20, 40) to a soft tissue target through an airway of a lung. The system 100 may be further configured to construct fluoroscopic-based three-dimensional volumetric data of the target region from the 2D fluoroscopic image to confirm navigation to the desired location. The system 100 may be further configured to facilitate approaching a medical device to a target area using electromagnetic navigation (EMN) and for determining a position of the medical device relative to the target. One such EMN system is the illumite system, but other systems for intra-luminal navigation are also considered to be within the scope of the present disclosure as described above.

One aspect of the system 100 is a software component for viewing Computed Tomography (CT) image scan data that has been acquired separately from the system 100. Viewing of the CT image data allows a user to identify one or more targets, plan a path to the identified targets (planning phase), navigate the catheter 20, 40 to the targets using a user interface on the computing device 122 (navigation phase), and confirm placement of the sensor 104 housed in the catheter 20, 40 relative to the targets. The target may be tissue of interest identified by examining the CT image data during a planning phase. After navigation, a medical device, such as a biopsy tool or other tool, may be inserted into the catheter 20, 40 to obtain a tissue sample from tissue at or near the target.

As shown in fig. 8, the catheters 20, 40 are part of a catheter guidance assembly 106. In practice, the catheters 20, 40 may be inserted into the bronchoscope 108 to access the luminal network of the patient P. In particular, the catheters 20, 40 of the catheter guide assembly 106 may be inserted into the working channel of the bronchoscope 108 for navigation through the patient's luminal network. Alternatively, the catheter guide assembly 106 may be navigated through a lumen network of a patient without using the bronchoscope 108 without departing from the scope of the present disclosure. The sensor 104 may be located on a distal portion of the catheter 20, 40. The positioning and orientation of the sensor 104, and thus the distal portion of the catheter 20, 40, with respect to the reference frame within the electromagnetic field can be obtained.

The system 100 generally includes: an operating table 112 configured to support a patient P, and a monitoring device 114 coupled to the bronchoscope 108 or the catheter guide assembly 106 (e.g., a video display for displaying video images received from a video imaging system of the bronchoscope 108); a positioning or tracking system 114 comprising a positioning module 116, a plurality of reference sensors 118, and an emitter pad 120 comprising a plurality of incorporated markers; and a computing device 122 comprising software and/or hardware for facilitating identification of a target, path planning to a target, navigation of a medical device to a target, and/or confirmation and/or determination of placement of the catheter 20, 40 or a suitable device passing therethrough relative to a target. The computing device 122 may be similar to the workstation 401 of fig. 9.

Also included in this particular aspect of the system 100 is a fluoroscopic imaging device 124 capable of acquiring fluoroscopic or X-ray images or video of the patient P. The images, image sequences, or videos captured by the fluoroscopic imaging device 124 may be stored within the fluoroscopic imaging device 124 or transmitted to the computing device 122 for storage, processing, and display. In addition, the fluoroscopic imaging device 124 may be moved relative to the patient P such that images may be acquired from different angles or perspectives relative to the patient P to create a sequence of fluoroscopic images, such as fluoroscopic video. The pose of fluoroscopic imaging device 124 relative to patient P and at the time of capturing the image may be estimated via markers incorporated with emitter pad 120. Markers are positioned beneath patient P, between patient P and console 112, and between patient P and the radiation source or sensing unit of fluoroscopic imaging device 124. The markers incorporated with the emitter pad 120 may be two separate elements that may be fixedly coupled or alternatively may be manufactured as a single unit. The fluoroscopic imaging device 124 may include a single imaging device or more than one imaging device.

Computing device 122 may be any suitable computing device including a processor and a storage medium, wherein the processor is capable of executing instructions stored on the storage medium. The computing device 122 may also include a database configured to store patient data, CT datasets including CT images, fluoroscopic datasets including fluoroscopic images and video, fluoroscopic 3D reconstruction, navigation plans, and any other such data. Although not explicitly shown, the computing device 122 may include input or may be otherwise configured to receive CT datasets, fluoroscopic images/video, and other data described herein. In addition, computing device 122 includes a display configured to display a graphical user interface. The computing device 122 may be connected to one or more networks through which one or more databases may be accessed.

With respect to the planning phase, the computing device 122 utilizes pre-acquired CT image data to generate and view a three-dimensional model or rendering of the airway of the patient P, enabling identification (automatically, semi-automatically, or manually) of the target on the three-dimensional model, and allowing determination of the path through the airway of the patient P to the tissue located at and surrounding the target. More specifically, CT images acquired from previous CT scans are processed and assembled into a three-dimensional CT volume, which is then utilized to generate a three-dimensional model of the airway of patient P. The three-dimensional model may be displayed on a display associated with computing device 122, or in any other suitable manner. Using the computing device 122, various views of the three-dimensional model or the enhanced two-dimensional image generated by the three-dimensional model are presented. The enhanced two-dimensional images may have some three-dimensional capabilities because they are generated from three-dimensional data. The three-dimensional model may be manipulated to facilitate identification of a target on the three-dimensional model or two-dimensional image, and selection of a suitable path through the airway of the patient P into tissue located at the target may be made. Once selected, the path plan, the three-dimensional model, and the images derived therefrom may be saved and exported into a navigation system for use during the navigation phase. The illumite software suite currently marketed by the meiton force company contains one such planning software.

With respect to the navigation phase, registration of the images and navigation paths are performed using a six degree of freedom electromagnetic positioning or tracking system 114 or other suitable system for determining the positioning and orientation of the distal portion of the catheter 20, 40. Tracking system 114 includes a tracking module 116, a plurality of reference sensors 118, and an emitter pad 120 (including markers). The tracking system 114 is configured for use with the catheters 20, 40 and in particular the sensor 104.

The emitter pad 120 is positioned below the patient P. The transmitter pad 120 generates an electromagnetic field around at least a portion of the patient P within which the positioning of the plurality of reference sensors 118 and sensors 104 may be determined using the tracking module 116. One or more of the reference electrodes 118 are attached to the chest of the patient P. Registration is typically performed to coordinate the three-dimensional model and two-dimensional images from the planning phase with the position of the airway of patient P as observed through bronchoscope 108, and to allow the navigation phase to proceed with knowledge of the position of sensor 104.

Registration of the position of patient P on emitter pad 120 may be performed by moving sensor 104 through the airway of patient P. More particularly, data relating to the position of the sensor 104 as the catheter 20, 40 moves through the airway is recorded using the emitter pad 120, the reference sensor 118, and the tracking system 114. The shape resulting from the position data is compared with the transferred internal geometry of the three-dimensional model generated in the planning phase and a position correlation between the shape based on the comparison and the three-dimensional model is determined, for example, using software on the computing device 122. In addition, the software identifies non-tissue spaces (e.g., air-filled cavities) in the three-dimensional model. The software aligns or registers the image representing the position of the sensor 104 with the three-dimensional model and/or the two-dimensional image generated by the three-dimensional model, based on the recorded position data and the assumption that the sensor 104 is still positioned in the non-tissue space in the airway of the patient P. Alternatively, a manual registration technique may be employed by: the bronchoscope 108 with sensor 104 is navigated to a pre-specified location in the patient's P lungs and the image from the bronchoscope is manually correlated with the model data of the three-dimensional model.

As described herein above, the catheter 20, 40 may contain one or more pull wires 26 that may be used to manipulate the distal portion of the catheter 20, 40. The pull wire 26 may be manually operated, power assisted, and robotically driven. Although certain pull wire systems are described in detail herein, the present disclosure is not so limited, and the same principles of extension and retraction of the pull wire may be employed by manual manipulation to change the shape of the distal portion of the catheter without departing from the scope of the present disclosure.

Although described herein with respect to an EMN system using an EM sensor, the present disclosure is not limited thereto and may be used in conjunction with a shape sensor, a flexible sensor, an ultrasonic sensor, or with other types of sensors. Additionally, the methods described herein may be used in conjunction with robotic systems to cause robotic actuators to drive the catheter 102 or bronchoscope 108 toward a target, as described in more detail below.

During navigation, upon reaching the bifurcation point, the catheter 20/40 is shaped to achieve the desired curvature of the shape of the catheter 20/40 to achieve rotation of the catheter 102 such that the distal end of the catheter 20/40 is aligned with the particular branch through which navigation is intended. Advancement of catheter 20/40 then ensures that the bends are so aligned that navigation will continue in the desired branch. The curvature of the catheter 20/40 may be adjusted based on the need for the curvature to reach a particular airway (e.g., when navigating the upper lobe of the lung).

Referring now to fig. 9, which is a schematic diagram of a system 200 configured for use with the methods of the present disclosure, including the method of fig. 4. The system 200 may include a workstation 201 and optionally a fluoroscopic imaging device or fluoroscope 215. In some embodiments, the workstation 201 may be coupled directly or indirectly with the fluoroscope 215, for example, through wireless communication. The workstation 201 may include a memory 202, a processor 204, a display 206, and an input device 210. The processor or hardware processor 204 may include one or more hardware processors. Workstation 201 may optionally include an output module 212 and a network interface 208. Memory 202 may store applications 218 and image data 214. The application 218 may include instructions executable by the processor 204 for performing the methods of the present disclosure.

The application 218 may also include a user interface 216. The image data 214 may include CT scans, fluoroscopic 3D reconstruction of the generated target region, and/or any other fluoroscopic image data and/or one or more slices of the generated 3D reconstruction. The processor 204 may be coupled with the memory 202, the display 206, the input device 210, the output module 212, the network interface 208, and the fluoroscope 215. The workstation 201 may be a stationary computing device such as a personal computer, or a portable computing device such as a tablet computer. The workstation 201 may embed a plurality of computer devices.

Memory 202 may include any non-transitory computer readable storage medium for storing data and/or software including instructions executable by processor 204 and which control the operation of workstation 201 and, in some embodiments, also control the operation of fluoroscope 215. In accordance with the present disclosure, fluoroscope 215 may be used to capture a sequence of fluoroscopic images based on which a fluoroscopic 3D reconstruction is generated and to capture a live 2D fluoroscopic view. In one embodiment, the memory 202 may include one or more storage devices, such as solid state storage devices, e.g., flash memory chips. Alternatively, or in addition to the one or more solid state storage devices, the memory 202 may include one or more mass storage devices connected to the processor 204 through a mass storage controller (not shown) and a communication bus (not shown).

Although the description of computer-readable media contained herein refers to a solid state storage device, it should be appreciated by those skilled in the art that computer-readable storage media can be any available media that can be accessed by the processor 204. That is, computer-readable storage media may include non-transitory, volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, program modules or other data. For example, a computer-readable storage medium may include RAM, ROM, EPROM, EEPROM, flash memory or other solid state memory technology, CD-ROM, DVD, blu-ray or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and which can be accessed by the workstation 1001.

The application 218, when executed by the processor 204, may cause the display 206 to present a user interface 216. The user interface 216 may be configured to present a single screen to a user that includes a three-dimensional (3D) view of a 3D model of a target from a perspective of a tip of the medical device, a real-time two-dimensional (2D) fluoroscopic view displaying the medical device, and a target marker corresponding to the 3D model of the target overlaid on the real-time 2D fluoroscopic view. The user interface 216 may be further configured to display the target mark in different colors depending on whether the medical device tip is aligned with the target in three dimensions.

The network interface 208 may be configured to connect to a network, such as a Local Area Network (LAN), a Wide Area Network (WAN), a wireless mobile network, a bluetooth network, and/or the internet, comprised of wired and/or wireless networks. The network interface 208 may be used to connect between the workstation 201 and the fluoroscope 215. The network interface 208 may also be used to receive image data 214. The input device 210 may be any device that a user may use to interact with the workstation 201, such as, for example, a mouse, keyboard, foot pedal, touch screen, and/or voice interface. The output module 212 may include any connection port or bus, such as, for example, a parallel port, a serial port, a Universal Serial Bus (USB), or any other similar connection port known to those skilled in the art. From the foregoing and with reference to the various figures, it will be appreciated by those skilled in the art that certain modifications may be made to the disclosure without departing from the scope of the disclosure.

Although detailed embodiments are disclosed herein, the disclosed embodiments are merely examples of the disclosure that may be embodied in various forms and aspects. For example, embodiments of an electromagnetic navigation system incorporating target coverage systems and methods are disclosed herein; however, the target overlay system and method may also be applied to other navigation or tracking systems or methods known to those skilled in the art. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.

Claims (20)

1. An endoluminal navigation catheter, the endoluminal navigation catheter comprising:

a catheter tube;

a first pull ring secured to the catheter tube and positioned proximate a distal end of the catheter tube;

a second pull ring secured to the catheter tube, the second pull ring being proximal to the first pull ring and including a lumen formed therein,

a pull wire permanently secured to the first pull ring;

a stop attached to the pull wire between the first pull ring and the second pull ring, the stop sized to prevent travel through the lumen in the second pull wire; and

an actuator operably connected to the pull wire, wherein the actuator is configured to retract the pull wire to initially cause bending in a distal portion of the catheter, and upon further retraction, to cause the stop to strike the second pull ring to cause bending of the catheter in a portion proximal to the first bending.

2. The endoluminal navigation catheter of claim 1 wherein the actuator is motor driven.

3. The endoluminal navigation catheter of claim 2 wherein the motor is robotically initialized.

4. The endoluminal navigation catheter of claim 2 wherein the motor is manually initialized.

5. The endoluminal navigation catheter of claim 1 wherein the stop is cross-shaped.

6. The endoluminal navigation catheter according to claim 1, wherein a pull wire is secured to a shuttle operably connected to a lead screw driven by a motor to advance and retract the pull wire.

7. The endoluminal navigation catheter according to claim 1, wherein the pull wire is fixed to a pulley, wherein the pulley retracts or advances the pull wire by rotation of a motor.

8. An endoluminal navigation catheter, the endoluminal navigation catheter comprising:

a catheter tube;

a first pull ring secured to the catheter tube and positioned proximate a distal end of the catheter tube;

a second pull ring secured to the catheter tube, the second pull ring being proximal to the first pull ring and including a lumen formed therein,

a first pull wire permanently secured to the first pull ring;

a second pull wire permanently secured to the second pull ring;

an actuator operably connected to the first pull wire and the second pull wire, wherein the actuator is configured to retract the first pull wire to cause a first bend in a distal portion of the catheter and is operably connected to the second pull wire to retract the second pull wire to cause a bend in a portion of the catheter proximal to the first bend.

9. The endoluminal navigation catheter of claim 8 further comprising a shuttle fixedly connected to the first pull wire and slidingly connected to the second pull wire.

10. The endoluminal navigation catheter according to claim 9, further comprising a stop formed on the second pull wire.

11. The endoluminal navigation catheter of claim 10, wherein the stop is formed on a proximal end of the second pull wire, wherein the shuttle is operably connected to a lead screw driven by a motor, wherein retraction of the shuttle actuates the first pull wire to cause the bend at the distal end of the catheter, and further retraction causes the stop to strike the shuttle to cause the catheter to cause a bend in a portion proximal to the first bend.

12. The endoluminal navigation catheter of claim 8 further comprising two pulleys, one pulley operatively connected to the first pull wire and one pulley operatively connected to the second pull wire, wherein retraction of the second pull wire begins after retraction of the first pull wire.

13. The endoluminal navigation catheter of claim 8 further comprising two pulleys, a first pulley operatively connected to the first pull wire and a second pulley operatively connected to the second pull wire, wherein the second pulley is smaller than the first pulley.

14. The endoluminal navigation catheter of claim 8 further comprising two pulleys, a first pulley operatively connected to the first pull wire and a second pulley operatively connected to the second pull wire, the first pulley comprising a first cam and the second pulley comprising a second cam, wherein rotation of the first pulley causes the first cam to act on the second cam to effect rotation of the second pulley.

15. An endoluminal navigation system, the endoluminal navigation system comprising:

a catheter, the catheter comprising

A catheter tube;

a sensor formed in a distal portion of the catheter tube;

a first pull ring secured to the catheter tube and positioned proximate a distal end of the catheter tube;

a second pull ring secured to the catheter tube, the second pull ring being proximal to the first pull ring and including a lumen formed therein,

a pull wire permanently secured to the first pull ring;

a stop attached to the pull wire between the first pull ring and the second pull ring, the stop sized to prevent travel through the lumen in the second pull wire;

a motor driven actuator operably connected to the pull wire, wherein the motor driven actuator is configured to retract the pull wire to cause bending in a distal portion of the catheter, and upon further retraction, to cause the stop to strike the second pull ring to cause bending of the catheter in a portion proximal to the first bend;

a tracking system configured to detect a location of the sensor; and

a computing device configured to depict the detected position of the sensor in a user interface on a display.

16. The endoluminal navigation system of claim 15, wherein the user interface displays one or more of a three-dimensional model of a luminal network, a fluoroscopic image, a computer tomogram, and a location of the sensor in the luminal network.

17. The endoluminal navigation system of claim 15 wherein the sensor is an electromagnetic sensor.

18. The endoluminal navigation system of claim 15 wherein the sensor is a shape sensor.

19. The endoluminal navigation system of claim 15 wherein the motor-driven actuator is robotically driven.

20. The endoluminal navigation of claim 15 further comprising a shuttle operably connected to the pull wire.