Wire navigation system with direct visualization features

Abstract

A navigation system with remote visualization elements is disclosed for navigation in remote spaces using a variety of imaging modalities including direct visualization in medical and non-medical applications.

Description

[0001] This application is a divisional application of Chinese patent application No. 201680055271.4, filed on March 22, 2018, entitled "Wire Navigation System with Direct Visualization Features".

[0002] Cross-references to related applications This application claims the benefit of U.S. Provisional Application No. 62 / 195,662, filed July 22, 2015, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to a medical device, and more specifically to a wire navigation system having an integrated visualization feature that enables a user to guide the medical device toward a remote space and make the medical device visible when navigating to the remote space. Background Technology

[0004] Leads are currently used in medical procedures to guide catheters, cannulas, sheaths, or other devices from remote sites to treatment sites within the patient. These treatment sites can sometimes be difficult to reach, being narrow, restricted areas with winding pathways. In a typical procedure, a lead is inserted from a distal part of the body through the patient's lumen toward the treatment site until it encounters an obstruction. When this occurs, an exchange catheter is advanced along the lead, the lead is withdrawn, and a new lead of a different (usually larger) size is advanced to the end of the exchange catheter. The catheter is then withdrawn, and the new lead is advanced further until it can no longer be advanced, or until a different size lead is needed. At this point, the exchange cycle repeats itself, using the exchange catheter to replace the lead of different sizes until the target is reached. This is typically performed under fluorescein guidance, is time-consuming, and requires the physician to rely on two-dimensional imaging for his or her decision-making.

[0005] Therefore, it is desirable to provide a wire navigation system having a visualization feature integrated into the system itself, enabling the execution of wire and conduit exchange cycles without the need for additional fluorescent guidance or any further visualization guidance, unless such additional guidance is desired. Summary of the Invention

[0006] This disclosure provides a navigation system with directly visualized features. The system may include multiple sliding members of different sizes and flexibility. The system can be advanced and retracted to change the diameter, flexibility, and stiffness of the entire system. Locks are also included to secure the system members to each other in relative positions. These properties of the system allow the system to navigate to a target location without engaging in multiple wire exchanges and without relying on a single imaging modality.

[0007] In some embodiments, a navigation system with a remote visualization element is provided for navigation in remote space in both medical and non-medical applications. The system may include multiple components to allow navigation without the need to exchange wires, catheters, and other navigation instruments to access a desired navigation point. This system eliminates the need to exchange between multiple devices to successfully navigate to a desired navigation point, while also providing a system with therapeutic capabilities for further diagnosis and treatment of diseases.

[0008] The system may include internal components comprising a remote visualization element. This visualization element is connected to a processor and a light source for imaging tissue or other material at a remote distance from the user. The navigation system may also include one or more external components, which may be coaxial or otherwise configured. These external components are configured for navigation within the lumen and for increasing the overall diameter and stiffness of the system as needed at any point during the procedure, without requiring instrument exchanges, such as to turn, navigate bifurcation, and traverse tortuous anatomy. The system is also configured such that its stiffness can be adjusted to support the propulsion of larger instruments on the navigation system.

[0009] The visualization feature incorporated into this system allows it to function as a "seeing" navigation system, enabling independent navigation via direct visualization through convoluted anatomy, cavities, and other hard-to-reach locations. It also allows for alteration of the system's overall diameter, stiffness, and flexibility, as well as the injection of infusible materials. The system also incorporates radiopaque materials, allowing navigation to be performed in other ways, including combining fluorescein guidance, ultrasound guidance, electromagnetic guidance, and direct visualization as needed, thereby enhancing the system's ability to navigate through diverse environments. This feature offers advantages over existing technologies that typically involve navigation using a single imaging modality such as fluorescein, and a single navigation capability, such as navigating one medical lead at a time and then engaging in exchanges between multiple leads to achieve different diameter and stiffness levels. This system provides a way to navigate using multiple imaging modalities and multiple navigation features, including the ability to change size, diameter, and stiffness in flight, without the time-consuming practice of using catheters to exchange one lead for another, which is currently the norm.

[0010] This system can be used in medical applications, particularly in gastrointestinal, vascular, coronary, urological, gynecological, pulmonary, ENT, neurological, orthopedic, and minor or minimally invasive surgical applications. It can also be used in non-medical applications where remote navigation and visualization are beneficial, particularly for inspecting gas lines, pipelines, hydraulic lines, viewing distant corners, and especially lower openings.

[0011] In an exemplary embodiment, the internal component having the remote visualization element has a diameter of less than 0.014 inches, and the system has an overall diameter of 0.035 inches or less. In other embodiments, the dimensions of the various components may be larger or smaller, including the overall diameter of the system.

[0012] In another exemplary embodiment, the visualization element may be located in one or more of the external elements of the system.

[0013] Visualization elements may include the ability to alter the spectrum to enhance the system's ability to examine, diagnose, and process substances. In some embodiments, visualization elements may be able to participate in narrowband imaging, high-resolution imaging, infrared imaging, ultrasound, and other forms of imaging and spectroscopy to improve the information provided to the user through the visualization element.

[0014] The system may include one or more locking mechanisms to hold the components together, so that the system can be navigated and used as a large-diameter guide with remote visibility, and can be unlocked for use, so that the individual components can move forward and backward as needed to propel the system.

[0015] In some embodiments, the third component may be part of the system to act as a reinforcement between the first and second components, and the third component may also act as a lock to secure the components together for navigation as a single system with adjustable flexibility and stiffness. In other embodiments, the system may include a lock as a fourth element of the system.

[0016] The component may be made of biocompatible materials, including, for example, metals (such as steel, nickel-titanium, cobalt-chromium) and other materials (such as polyetheretherketone (PEEK), polymers, and other elastic materials). The component may be rigid or flexible, partially or entirely helical-cut, and fully or partially covered with a coating. In some embodiments, the coating may include polytetrafluoroethylene (PTFE), polyethylene terephthalate (PET), and other biocompatible materials. The coating may also include coatings that alter the properties of materials in a fluid, including hydrophobic, superhydrophobic, and hydrophilic coatings, as well as anti-inflammatory, antibacterial, antimicrobial coatings, and electroresponsive coatings.

[0017] One or more components may be steerable. This can be achieved by having external components or by having steerable internal components, the external components having steerability to rotate and guide the system, and the external components then advancing on the internal components to adjust flexibility, stiffness, and diameter. Furthermore, by using locking mechanisms, the components of the system can be locked together, thus, based on the combined features formed by locking or fixing the system components, the system uniquely possesses unique properties associated with the combined / locked features of the system, including steerability, flexibility, diameter, imaging, and visualization capabilities.

[0018] In some embodiments, the system's steering capability can be achieved through torque transmission by twisting one or more components at their proximal ends and transmitting torque to the system to cause the distal ends of one or more components to rotate. The system can also be steerable by a combination of components having external or internal components, or components having cables, piezoelectric materials, electroactivated polymers, interlocking components, or other elements, to selectively transmit forces across a portion of the system or across the entire system to cause it to rotate in one or more directions. The system can also be steerable by having small robotic elements (including ultrasonically driven or electric motors and / or organic conductors) with the ability to change shape as intended to steer one or more components of the device. The device can be directly navigated and articulated by a user, or as part of an automated or robotic system where user input is transmitted through the system via various means, including, for example, cables, power connectors, motors, electromagnetic energy, sliding sheaths, tactile feedback, computer guidance and orientation input, and other means, to guide and direct the device to its intended location, including to targets in specific diagnostic and treatment patients, or to desired remote locations in non-medical applications.

[0019] The internal components may also have variations that may or may not include visualization. The internal components may have a cutting blade that is fixed or can be advanced and withdrawn to cut, remove, or dissect tissue, plaque, or other material. In some embodiments, the blade may be straight, curved, spiral, or other shapes for removing, cutting, or dissecting tissue or other material.

[0020] One of the components may have a gripping element for biopsy of tissue, or one of the components may include a brush to capture cells or other substances. The internal components may also be solid elements, and one or more of the components may have the ability to be powered to affect tissue and other substances, including blood clots. The energy may be directed to specific tissue or other substances (such as blood clots or cancerous tumors), including forming an electromagnetic field focused on a specific treatment or diagnostic area to facilitate the guidance of instruments or drugs in response to energy directed to the target location.

[0021] One or more components may have pressure or temperature sensors to provide the user with additional feedback on the area in which the system is navigating, diagnosing, and treating. One or more sensors may be arranged to form a three-dimensional or four-dimensional image.

[0022] The system may include infusion management capabilities to infuse various fluids, gases, imaging agents, and other infusible substances. This includes infusing contrast agents, carbon dioxide, oxygen, water, pharmaceuticals, adhesives, and other infusible substances. The infusion system includes valves to prevent the inflow of air or other unwanted substances and to prevent backflow of substances once they have entered the system. The infusion system may include flushing ports to remove substances from the system, thus allowing the infusion of additional infusible substances without mixing multiple types of infusible substances. The infusion management system may include one or more ports with locking elements for connection to bags, syringes, or other retainers and dispensers of infusible substances. The infusion management system may also include mixing elements to combine infusible substances prior to infusion or to infuse multiple substances simultaneously. If the infusible substance contains toxic elements, such as chemotherapeutic agents or radioactive isotopes (such as radiospheres used to treat liver cancer), the infusion management system may include shielding materials to protect healthcare workers, including shielding materials composed of lead and other protective materials.

[0023] The injection system can be connected to other components via connectors aligned with the system's axis or at an angle to the system's axis. The ability to inject non-fusible materials into the system can also be integrated into system components, including as part of a locking mechanism that can also inject materials, or as components of the system that can change the system's diameter, stiffness, and flexibility and inject materials.

[0024] The injection system can be detached from the wire navigation system, or all or part of the injection system can be an attached or integrated part of the system.

[0025] An injection management system may include the ability to systematically inject a substance within a defined time period. One example is an injection bead, which has been mixed with a chemotherapeutic agent and a contrast agent by the injection management system and then injected into a liver tumor within a set injection time to ensure proper dispersion at the tumor site. In some embodiments, timed delivery may involve an injection element connected to an inlet as part of the injection management system. In some embodiments, timed delivery may occur via an electric motor, spring, gravity supply system, or pump-based system, wherein the electric motor generates pressure to propel the infusible substance sequentially or otherwise, the spring mechanically releases over time to apply pressure to a plunger or other element to inject the substance, in the gravity supply system the infusible substance is timed to be released from the gravity supply system, or the pump-based system pumps the infusible substance into the system in a programmable or user-determined manner.

[0026] In some embodiments, the fluid management system may consist of a hemostatic valve and one or more luer locks and stopcocks with Y-shaped connectors to manage and inject fluid flows, drugs, beads (including microparticles and nanoparticles) and other substances through the lumen of the navigation system.

[0027] The system may include biopsy instruments for sampling tissue or other substances at one or more locations. In some embodiments, the biopsy element may be an internal or other component of the system, or it may be contained within a sheath that is pulled back to remove tissue or exposed as one of the external components of the system. The biopsy instrument may have a capture element that draws the removed tissue to the outside of the system via the biopsy element, or the biopsy element may have an internal element for capturing biopsy tissue, enabling multiple biopsies to be performed while in a patient. In some embodiments, the tissue contact aspect of the biopsy element may involve a jaw, an articulated jaw, a core element (which removes tissue by means of a penetrating and rotating device that can remove tissue directly in front of the element through penetration), or have a dissection or articulated arm element for removing tissue. In some embodiments, the system may include a brush as part of a component to advance and capture cells for diagnostics and testing.

[0028] In some embodiments, the system may include a component capable of capturing stones or other substances in a basket or other capturing element. In some embodiments, the basket may be capable of hinged, closed, and opened, including the ability to use the system's visualization capabilities to precisely position the basket to advance over and grasp or capture the stones. In other embodiments, the system may include a laser element to ablate the stones before removal.

[0029] In some embodiments, the system may include components capable of articulating and cutting tissue, including pathways for widening bile ducts or similar anatomical structures. The cutting may occur mechanically, such as with a cutting component comprising a sharp element for cutting the tissue. Alternatively, the cutting may be achieved by various means to cut tissue, such as by delivering energy, including with a blade, thread, or the edge of a component, or by a combination of these elements. The energy form may include monopolar energy, bipolar energy, microwave energy, and ultrasonic energy.

[0030] In some embodiments, a navigation system is provided having an inner member and an outer member having an inner diameter larger than the outer diameter of the inner member. The outer member may include a flexible tube with different flexible regions. The system may further include a lumen between the inner and outer members and an alternative lumen passing through the outer member. One of the members may have imaging capabilities, including ultrasound, magnetic imaging, remote visualization elements, or other forms of visualization or imaging in addition to fluorescence microscopy. In some embodiments, one of the members includes a cutting line. In other embodiments, one of the members includes a needle knife for dissection and tissue energization. In other embodiments, the system can be remotely steered via one or more of its members.

[0031] It should be understood that the foregoing general description and the following detailed description are merely exemplary and explanatory, and not intended to limit the scope of this disclosure. Additional features of this disclosure will be set forth in part in the following description, or may be learned by practice of this disclosure. Attached Figure Description

[0032] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present disclosure and, together with the specification, serve to explain the principles of the present disclosure.

[0033] Figure 1 A perspective view of an exemplary embodiment of the conductor system of this disclosure is shown.

[0034] Figure 2 A perspective view of another exemplary embodiment of the conductor system of this disclosure is shown.

[0035] Figure 3 A perspective view of another exemplary embodiment of the conductor system of this disclosure is shown.

[0036] Figure 4 A perspective view of another exemplary embodiment of the conductor system of this disclosure is shown.

[0037] Figure 5 An exploded perspective view of an exemplary embodiment of the conductor system of this disclosure is shown.

[0038] Figure 6 An enlarged perspective view of an exemplary embodiment of the external components of this disclosure is shown.

[0039] Figure 7 An exploded perspective view of another exemplary embodiment of the conductor system of this disclosure is shown.

[0040] Figure 8 An exploded perspective view of another exemplary embodiment of the conductor system of this disclosure is shown.

[0041] Figure 9A perspective view of another exemplary embodiment of the conductor system of this disclosure is shown.

[0042] Figure 10 A perspective view of another exemplary embodiment of the conductor system of this disclosure is shown.

[0043] Figure 11 A perspective view of another exemplary embodiment of the conductor system of this disclosure is shown. Detailed Implementation

[0044] Now turn to the attached image. Figure 1 An exemplary embodiment of the guiding system of this disclosure is shown. System 100 may include an internal component 110 and an external component 120. The internal component 110 may incorporate a visualization element 130 connected to an imaging system 140. This enables direct visualization and imaging during navigation.

[0045] The external component 120 may further include a coating 124. As described, the coating 124 may include PTFE, PET, or other biocompatible materials. The coating 124 may also alter the properties of materials in the fluid, such as by acting as a hydrophobic, superhydrophobic, or hydrophilic coating. The coating 124 may also be anti-inflammatory, antibacterial, antimicrobial, and / or electroresponsive.

[0046] Figure 2 Another exemplary embodiment of the wire system of this disclosure is shown. System 200 may include an internal component 210 and an external component 220. The internal component 210 may have an ultrasonic sensor 230 and / or a pressure sensor 234 or more sensors integrated therein, and then it is connected to an ultrasonic processor 240 and / or a pressure monitor 244. Similar to Figure 1 In system 100, the external component 220 may also include a coating 224. The coating may include PTFE, PET, or other biocompatible materials. In one exemplary embodiment, the internal component 210 and the external component 220 may include coatings. The materials of the coatings may be the same or different. For example, the internal component 210 may have a PTFE coating while the external component may have a PET coating, or vice versa.

[0047] Figure 3 Another exemplary embodiment of the wire system of this disclosure is shown. System 300 may include an internal component 310 and an external component 320. The internal component 310 may have a cutting or dissecting element 330 incorporated therein, which may be connected to an external power source. To facilitate the process, the external component 320 may have a camera or visualization feature 350 incorporated therein. The internal component 310 or the external component 320 may have a coating as previously described.

[0048] Figure 4Another exemplary embodiment of the conductor system of this disclosure is illustrated. System 400 may include an internal component 410, an intermediate component 420, and an external component 430. The external component 430 may have, as for Figure 1 The coating is described in the external component 110 of system 100. The internal component 410 may have a visualization element 440 incorporated therein, which is then connected to a similar... Figure 1 The imaging system of system 100 described herein (not shown). However, system 400 may also include an external member 430 having a retrieval element 460. As shown, the retrieval element 460 may include a basket for collecting tissue and biological material. The basket may be configured to be collapsible and deployable if desired.

[0049] One intended use of system 400 is to capture stones (e.g., kidney stones) or other substances in basket 460. In some embodiments, basket 460 may have the ability to hinge, close, and open, including the ability to use the visualization element 440 of system 400 to precisely position basket 400 to advance and grasp or capture stones. Additionally, a laser element (not shown) may be incorporated into system 400 to allow for the ablation of stones prior to capture and removal from the patient. The laser element may be incorporated into internal component 410 or into a separate component as shown.

[0050] Figure 5 Another exemplary embodiment of the wire system of this disclosure is shown. System 500 may include an internal component 510, an intermediate component 520, and an external component 530. The external component 530 may have, as for Figure 1 The coating is described in the outer component 110 of system 100. The inner component 510 may have a visualization element 540 incorporated therein, which is then connected to a similar... Figure 1 The imaging system (not shown) of system 100 described herein.

[0051] Additionally, system 500 may include tissue cutting or excision and removal features. For example, as shown, internal member 510 and external member 530 may have cutting elements such as a blade 550 and a biopsy forceps 560 at their distal ends 512, 532. As previously described, internal member 510 may have a blade 550 that is fixed or can be advanced and withdrawn to cut, excise, or dissect tissue, plaque, or other material. In some embodiments, the blade may be straight, curved, spiral, or other shapes for excising, cutting, or dissecting tissue or other material. As shown, external member 530 may have a biopsy forceps 560 at its distal end 532 to remove excised tissue and is in communication with a biopsy forceps controller 564.

[0052] Figure 6An exemplary embodiment of an external member 600 that can be used in any system of this disclosure is shown. In some applications, the external member 600 may also be used as an intermediate member. As shown, the external member 600 may include a series of tapered laser cutouts 620, which allow selected areas of the member 600 to have different flexibility than adjacent areas. This feature contributes to the steering and navigation of the entire system.

[0053] Additionally, the external component 600 may further include a coating 640. As described, the coating 640 may include PTFE, PET, or other biocompatible materials. The coating 640 may also alter the properties of materials in the fluid, such as by acting as a hydrophobic, superhydrophobic, or hydrophilic coating. The coating 640 may also be anti-inflammatory, antibacterial, antimicrobial, and / or electroresponsive, such as by including an electroactivated polymer.

[0054] As described above, the system disclosed herein may include one or more locking mechanisms to secure the components together, thus enabling the system to be navigated and used as a large-diameter guide with remote visibility, and to be unlocked for use, allowing the individual components to move forward and backward as needed to propel the system. By using the locking mechanisms, the components of the system can be locked together, thus, based on the combined features formed by locking or securing the system components, the system uniquely possesses unique properties associated with the combined / locked features of the system, including steerability, flexibility, diameter, and visibility.

[0055] Furthermore, as described above, the system may include infusion management capabilities to infuse various fluids, gases, imaging agents, and other infusible substances through the system. This includes infusing contrast agents, carbon dioxide, oxygen, water, pharmaceuticals, adhesives, and other infusible substances. The infusion system includes valves to prevent the inflow of air or other unwanted substances and to prevent backflow of substances once they have entered the system. The infusion system may include flushing ports to remove substances from the system, thus allowing the infusion of additional infusible substances without mixing multiple types of infusible substances. The infusion management system may include one or more ports with locking elements for connection to bags, syringes, or other retainers and dispensers of infusible substances. The infusion management system may also include mixing elements to combine infusible substances prior to infusion or to infuse multiple substances simultaneously. If the infusible substance contains toxic elements, such as chemotherapeutic agents or radioactive isotopes (such as radiospheres used to treat liver cancer), the infusion management system may include shielding materials to protect healthcare workers, including shielding materials composed of lead and other protective materials.

[0056] The injection system can be connected to other components via connectors aligned with the system's axis or at an angle to the system's axis. The ability to inject non-fusible materials into the system can also be integrated into system components (including as part of a locking mechanism that can also inject materials), or into components of the system that can change the system's diameter, stiffness, and flexibility and inject materials. The injection system can be detached from the system, or all or part of the injection system can be an attached or integrated part of the navigation system.

[0057] Figure 7 and Figure 8 These principles are illustrated. For example... Figure 7 As shown, system 700 may include an internal component 710 and an external component 720. The internal component 710 may have a visualization element 730 incorporated therein, which is connected to an imaging system (not shown) to enable direct visualization during navigation.

[0058] As further shown, system 700 may include connector 740, such as a Y-connector having one or more injection ports 744. The Y-connector may include a valve 750, such as a hemostatic valve 750, at one end. This valve 750 may be configured as part of a lock, or it may be configured to be connected to the internal member 710 with a locking member 760. The other end of the Y-connector may be attached to a fluid source for injecting a non-fusible material.

[0059] Figure 8 An exemplary embodiment of a wiring system 800 is shown, wherein the inner member 810, the intermediate member 820, and the outer member 830 may include locking elements 812, 822, 832 to lock together and operate consistently as a single member. (As shown in...) Figure 7 In system 700, system 800 may incorporate an injection feature. For example, locking member 812 may also connect internal member 810 to other components, such as valve 840 attached to connector 850 with one or more ports 854 for injecting flowable material. Connector 850 may be in fluid communication with other components, such as mixer 860, timing injection element 870, and flushing element 880. In cases where the material to be injected contains toxic elements, mixer 860 may have a shield 864 to protect the user.

[0060] Figure 9Another exemplary embodiment of the lead system 900 is shown, wherein the system 900 includes an imaging element 912, which may be, for example, a direct visualization element, an ultrasound element, or other visualization or imaging element. In one embodiment, the imaging element 912 is associated with an internal member 910. The lead system 900 may have a steerable external element 940, and in one embodiment, the external element 940 is associated with an external member 930. In some embodiments, the system 900 may also include a cutting element 950 (such as bipolar or monopolar wire) for cutting tissue or other materials. As shown, the cutting element 950 may be associated with a portion of the external element 940.

[0061] Figure 10 Another exemplary embodiment of the lead system 1000 is shown, wherein the system 1000 may include a cutting element 1050 for cutting tissue (such as, for example, an energized needle knife). In some embodiments, the cutting element 1050 may be associated with an internal member 1010. Additionally, the system 1000 may have an imaging element 1012, which may be a direct visualization element, an ultrasound element, or other visualization or imaging element. The imaging element 1012 may be associated with an external member 1030. The external member 1030 may also have an associated steerable element 1040 for steering the system 1000, and the ability to transmit concentrated electromechanical energy to guide the delivery of the needle knife 1050 or other instruments. It is contemplated that the needle knife 1050 may be configured to cut mechanically, or to cut tissue or other materials using energy from a bipolar or monopolar energy source. As previously described, one or both of the internal and external members may further include a coating.

[0062] Figure 11 Further exemplary embodiments of the lead system 1100 are shown, wherein the internal component has been withdrawn (not shown) and the external component 1130 is configured for injection. For example, as shown, the external component 1130 may have an internal lumen 1160 for injecting materials, such as delivering a drug. The external component 1130 may also include aggregated electromechanical energy elements to focus electromechanical energy on a target such as a blood clot or tumor to guide the delivery of the injected medium or substance (e.g., a drug having magnetizable nanoparticles) to the blood clot, tumor, or other target. Similar to the previous system, the external component 1130 may also have an associated steerable element 1140 for steering the steering system 1100. As previously described, one or both of the internal and external components may further include a coating.

[0063] Other embodiments will be apparent to those skilled in the art from the description and practice of the embodiments disclosed herein. The specification and examples are intended to be considered exemplary only, and the true scope and spirit of these embodiments are indicated by the following claims.

Claims

1. A navigation system comprising: Internal components; An external component having an inner diameter larger than the outer diameter of the internal component, the external component comprising a flexible tube with different flexible regions; A lumen between the inner component and the outer component; One of the components has a visualization element configured to provide an optical field of view of an area adjacent to or close to one of the components; as well as A locking element for securing the internal component to the external component.

2. The navigation system according to claim 1, wherein, The external component includes a series of tapered cuts, which allow selected areas of the external component to have different flexibility than adjacent areas.

3. The navigation system according to claim 1, wherein, The internal components include wires.

4. The navigation system according to claim 3, wherein, The system comprises a series of internal components with different diameters or stiffnesses.

5. The navigation system according to claim 1 further includes an ultrasonic sensor.

6. The navigation system according to claim 1 further includes a pressure sensor.

7. The navigation system according to claim 1 further includes a tissue resection or ablation element.

8. The navigation system according to claim 1 further includes a camera element.

9. The navigation system according to claim 1 further includes an organization retraction element.

10. The navigation system according to claim 7, wherein, The tissue removal or ablation element includes a scalpel, blade, cutting line, or laser.

11. The navigation system according to claim 9, wherein, The tissue recovery element includes a basket or clamps.

12. The navigation system according to claim 1, wherein, One or more of the components include a coating.

13. The navigation system according to claim 12, wherein, The coating includes PTFE, PET, hydrophobic coating, superhydrophobic coating, hydrophilic coating, anti-inflammatory coating, antibacterial coating, antimicrobial coating, or electroresponsive coating.

14. The navigation system according to claim 1 further includes a fluid management system.

15. The navigation system according to claim 14, wherein, The fluid management system includes a fluid connector with an injection port.

16. The navigation system according to claim 14, wherein, The fluid management system includes a mixer.

17. The navigation system according to claim 14, wherein, The fluid management system includes a timed injection element.

18. The navigation system according to claim 14, wherein, The fluid management system includes flushing elements.

19. The navigation system according to claim 14, wherein, One or more components in the fluid management system include a protective cover.

20. The navigation system according to claim 1, wherein, One of the components is configured to deliver directional magnetic energy for guiding drug delivery or devices to a target site.

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