WO2016001782A1

WO2016001782A1 - Integrated active fixation system for scope navigation

Info

Publication number: WO2016001782A1
Application number: PCT/IB2015/054497
Authority: WO
Inventors: Gregory Cole; Vijay Parthasarathy; Hao SU
Original assignee: Koninklijke Philips N.V.
Priority date: 2014-06-30
Filing date: 2015-06-15
Publication date: 2016-01-07

Abstract

A fixation system includes a securing system (104) mountable in operative proximity to a subject and configured to receive a device (102) to be navigated inside an orifice of the subject. A control module (110) is coupled to the securing system and configured to activate an active restraint of the securing system to restrain the device in accordance with at least one of sensor feedback or a control device activated by a user. A feedback system (106) is configured to provide information to the control module or the user regarding a status of device-to-subject interaction.

Description

INTEGRATED ACTIVE FIXATION SYSTEM FOR SCOPE NAVIGATION

BACKGROUND:

Technical Field

This disclosure relates to medical instruments and, more particularly, to integrated device fixation systems for use in medical and other applications.

Description of the Related Art

Peripheral lung lesions are not reachable with the use of standard bronchoscopy techniques. Navigation bronchoscopy, a method to extend the reach of a bronchoscope, relies on using real-time guidance of tools beyond the reach of a bronchoscope. During a bronchoscopy procedure, a clinician often employs both hands to operate a bronchoscope: one to feed the bronchoscope into the patient, and the other to rotate the handle and flex a steering lever. During such a procedure, there are a variety of other tasks the clinician must accomplish, which involve the use of the clinician's hands. These tasks may necessitate the clinician to delegate the task to another attendant, or have an attendant hold the bronchoscope in place while they perform the task themselves. Current bronchoscopic systems involve manual clamping mechanisms or require the use of assistants to temporarily hold the bronchoscope.

With navigational bronchoscopy procedures, in addition to the regular bronchoscope, there may be a steerable catheter that must be manipulated. The use of such catheters in the workflow makes procedures more cumbersome. This reduces the chances for adopting such techniques for such procedures in the future. SUMMARY

In accordance with the present principles, a fixation system includes a securing system mountable in operative proximity to a subject and configured to receive a device to be navigated inside an orifice of the subject. A control module is coupled to the securing system and configured to activate an active restraint of the securing system to restrain the device in accordance with at least one of sensor feedback or a control device activated by a user. A feedback system is configured to provide information to the control module or the user regarding a status of device-to-subject interaction.

Another fixation system includes a processor and memory coupled to the processor. A securing system is configured to receive a device to be navigated inside an orifice of a subject. A control module is included in the memory, the control module being configured to activate an active restrictive element of the securing system to restrain the device in accordance with at least one of sensor feedback or a control device activated by a user. A feedback system is configured to provide information to at least one of the control module or the user regarding a status of device-to-subject interaction. The feedback system includes a display for displaying feedback information to the user.

A method for fixation of a device includes passing a device through a securing system mounted in proximity of an orifice of a subject; positioning the device to reach a target region through the orifice; activating an active element of the securing system to restrain the device in accordance with at least one of sensor feedback or a control device activated by a user; and providing feedback to at least one of a control module or the user regarding a status of device-to-subject interaction.

These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings. BRIEF DESCRIPTION OF DRAWINGS

This disclosure will present in detail the following description of preferred

embodiments with reference to the following figures wherein:

FIG. 1 is a block/flow diagram showing a system/method for fixation of a

bronchoscope in accordance with one illustrative embodiment;

FIG. 2 is a diagram showing a display screen or dashboard for relaying feedback and providing controls to a user in accordance with one illustrative embodiment;

FIG. 3 is a diagram showing a clamping or securing system for a bronchoscope in accordance with another illustrative embodiment;

FIG. 4 is a diagram showing a clamping or securing system using a pneumatic cylinder for a bronchoscope in accordance with another illustrative embodiment;

FIG. 5 is a diagram showing a linear electronic actuator, which can be employed as a substitute for the pneumatic cylinder in FIG. 4, in accordance with another illustrative embodiment;

FIG. 6 is a diagram showing a clamping or securing system using a friction wheel assembly for a bronchoscope in accordance with another illustrative embodiment;

FIG. 7 is a diagram showing two views of a support or positioning armature employed for supporting the clamping or securing system in accordance with one illustrative

embodiment;

FIG. 8 is a flow diagram showing a method for device fixation to permit greater autonomy of a user in accordance with an illustrative embodiment; and

FIG. 9 is a flow diagram showing another method for device fixation to permit greater autonomy of a user in accordance with another illustrative embodiment. DETAILED DESCRIPTION OF EMBODIMENTS

In accordance with the present principles, securing or clamping systems and methods are described to assist a user during a procedure, operation, task, etc. In one embodiment, an actively triggered securing system is provided to enable a "third hand" for engaging a bronchoscope fixation system or other device or system. The securing system includes a device or devices that lock down or resist motion to a medical device or the like. An advanced control system provides force sensing (and/or displacement sensing) control integrated into the clamp or securing mechanism that can be used for providing force feedback to reduce patient trauma. A feedback system provides feedback to the clinician on patient status and other feedback, such as haptic feedback, may be employed for guidance.

It should be understood that the present invention will be described in terms of medical instruments; however, the teachings of the present invention are much broader and are applicable to any securing instruments. In some embodiments, the present principles are employed in navigating, tracking or analyzing complex biological or mechanical systems. In particular, the present principles are applicable to internal tracking and operating procedures of biological systems and/or procedures in all areas of the body such as the lungs, gastrointestinal tract, excretory organs, blood vessels, etc. The elements depicted in the FIGS, may be implemented in various combinations of hardware and software and provide functions which may be combined in a single element or multiple elements.

The functions of the various elements shown in the FIGS, can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared. Moreover, explicit use of the term "processor" or "controller" should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor ("DSP") hardware, read-only memory ("ROM") for storing software, random access memory

("RAM"), non-volatile storage, etc.

Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Thus, for example, it will be appreciated by those skilled in the art that the block diagrams presented herein represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, it will be appreciated that any flow charts, flow diagrams and the like represent various processes which may be substantially represented in computer readable storage media and so executed by a computer or processor, whether or not such computer or processor is explicitly shown.

Furthermore, embodiments of the present invention can take the form of a computer program product accessible from a computer-usable or computer-readable storage medium providing program code for use by or in connection with a computer or any instruction execution system. For the purposes of this description, a computer-usable or computer readable storage medium can be any apparatus that may include, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device. The medium can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device) or a propagation medium. Examples of a computer-readable medium include a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk - read only memory (CD-ROM), compact disk - read/write (CD-R/W), Blu-Ray™ and DVD.

Referring now to the drawings in which like numerals represent the same or similar elements and initially to FIG. 1, a system 100 for performing a procedure using an active fixation system is illustratively shown in accordance with one embodiment. System 100 may include a workstation or console 1 12 from which a procedure is supervised and/or managed. Workstation 1 12 preferably includes one or more processors 1 14 and memory 1 16 for storing programs and applications. Memory 1 16 may store an image, data and/or signal processing module 136 configured to interpret feedback signals from one or more sensors (e.g., sensors 107, 109) or systems. In one embodiment, a bronchoscope 102 is employed for navigating the lungs and/or performing surgical procedures. It should be understood that other scopes and medical instruments may be employed instead of or in addition to the bronchoscope 102. For example, the device 102 may include a catheter, a guidewire, a probe, an endoscope, a robot, an electrode, a filter device, a balloon device, or other medical component, etc., or the device 102 may be employed in conjunction with one or more of these or other instruments.

An active fixation system 105 includes an active securing system 104, a control system or module 1 10 and a feedback system or mechanism 106 (e.g., one or more sensors of a same or different type). The control system or module 1 10 may be incorporated into the memory 1 16 or may include a stand-alone unit. For example, the active securing system 104, control system 110 and feedback system 106 may be integrated with or partially integrated with software in a scope navigation and control module 122. The fixation system 105 provides a secure position to dock the bronchoscope 102 and or a distal end portion 108 of the scope 102. The securing system 104 and feedback system 106 (e.g., a sensor) can be employed to sense insertion force of the distal end portion 108 to enhance patient safety and reduce trauma. In addition, the feedback system 106 can provide feedback to guide navigation (e.g., haptic feedback, etc.).

In one embodiment, a lung navigation system may be employed, which employs an electromagnetically tracked navigation system (e.g., Philips® Invivo™) for performing peripheral lung biopsies. By employing the present principles, the use of such a system reduces complicated workflow and high procedure costs. The workflow is streamlined and costs reduced by at least reducing the number of personnel hours for a procedure.

In one embodiment, workstation 1 12 includes the image/data processing module 136 configured to receive feedback from the bronchoscope 102, the feedback system 106 and/or the control system 1 10. The image/data processing module 136 can generate images and/or displays on a display device 138. Workstation 1 12 includes the display 138 for viewing internal images of a subject (patient) 130 or target volume 132 and may include an overlay image or other rendering of the positions of the bronchoscope 102. Display 138 may also permit a user to interact with the workstation 1 12 and its components and functions, or any other element within the system 100. This is further facilitated by an interface 120 which may include a keyboard, mouse, a joystick, a haptic device, or any other peripheral or control to permit user feedback from and interaction with the workstation 1 12.

In particularly useful embodiments, the securing system 104 may include an actively triggered clamping system that preferably employs a hands-free trigger, such as a foot pad, or a sound or voice recognition application. For example, in particularly useful devices, the hands-free trigger may include a foot pedal, allowing the clinician to continue to use both hands to control the bronchoscope until it is secured; a switch or button integrated into one of the buttons on the bronchoscope using a software application; a voice command, requiring no physical interaction, but employing a microphone and speech recognition software; a software trigger, responding to an event predetermined by the software or user (e.g., a position of the scope); etc. The hands-free trigger may fix the bronchoscope upon activation of the trigger or upon release of the trigger.

By making the securing system 104 active instead of passive, the "third hand" problem of engaging a bronchoscope fixation system can be addressed. Active clamping means that the bronchoscope is held fast or is fixed by the system whether the clinician holds the bronchoscope or not, and the fixation force is generated by an actuated device and not the user. The securing system 104 may also provide resistive forces to a particular motion or displacement. This may include permitting movement but restricting speed or the amount of displacement or rotation. The securing system 104 may employ one or more different actuation technologies including but not limited to pneumatic cylinders, hydraulics, solenoids, piezoelectric actuators, gear systems, wheels, motors, etc. The securing system 104 may include chucks that directly engage the device 102 to hold the device fast to resist or prevent rotation and/or translation of the device 102 when the chucks are engaged.

The control system 1 10 may employ a force sensor or sensors (feedback system 106) integrated into the securing system 104 and, in particular the chucks, for providing force feedback to reduce patient trauma and control the type and amount of motion of the device 102. The control system 1 10 provides an advanced control mechanism in addition to providing binary on/off states for the securing system 104. The control system 1 10 employs the feedback system 106 to set power, speed, force, displacement, etc. of the securing system 104. The feedback system 106 may include force sensors 109, depth or position sensors 107 or other sensors embedded in or coupled to the securing system 104 (or elsewhere). The advanced control mechanism (1 10) may provide intermediate states between binary on/off states to increase/decrease force or displacement or other parameters of the securing system 104.

The sensing or feedback system 106 can be employed to provide the following features. The sensing system 106 includes insertion force detection, which, when used in conjunction with the securing system 104, can permit the user to modulate the insertion force of the bronchoscope 102 or other device. The securing system 104 may be configured to reduce trauma during a procedure. The sensing system 106 can provide force-feedback control by using the securing system 104 with sensor 109 to detect the force being exerted by the subject 130 on the bronchoscope 102. Trauma can be avoided during times when the securing system 104 is being used to support the bronchoscope 102. This can be accomplished through adjustment of the control parameters of the system 100, whether it is a holding force on the bronchoscope 102, or positional adjustment of the securing system 104 via motion enabled through a supporting arm 124, which may be secured to a platform 134, e.g., a gurney, a table or bed.

The sensing or feedback system 106 may include sensors 107, etc. that can be employed for position feedback. Information from the depth sensors 107 can be used both for closed loop control of the bronchoscope 102 via actuated motion or to give additional position and motion feedback for navigation. The feedback system 106 can also provide feedback to the clinician on patient status, status of the device 102 and also provide haptic feedback for guidance. Haptic guidance may include vibrations propagated through the device to indicate a particular condition (e.g., scope advanced too far, too much force on scope, etc.).

The data from the control system 1 10 and the sensing system 106 can then be displayed as part of an overall navigation package, e.g., as a dashboard in FIG. 2. Data like the insertion force and insertion depth can be displayed to the user as part of the visualization platform.

Using this data, the user can choose to operate the control system 1 10, which adds sensitivity to the patient status so that the bronchoscope 102 can be released without causing damage to the patient. In addition, haptic navigation guidance can also be provided if the user chooses to activate this feature. If the user attempts to go out of the prescribed navigation path as defined by a virtual fixture constraint (as tracked by the system 100), the resistance in the securing system 104 can be increased as a method to provide feedback to the user. Other features are also contemplated.

Referring to FIG. 2, an illustrative display screen 170 depicts an exemplary screen shot for a bronchoscopy procedure. A plurality of panes 172 depicts camera images, models, airways, phantom images and any other useful image for conducting or preparing for a procedure. An additional pane or dashboard 174 provides the feedback from the sensing or feedback systems 106, 107, 109, etc. The pane 174 displays a patient status relative to the securing system 104. The pane 174 may include a plurality of indicators or soft switches or devices. For example, a first indicator 176 may display an insertion force, a second indicator 178 may display an insertion depth and a soft switch or button 180 may be employed to activate a haptic feedback/guidance feature, a voice recognition feature, etc. of the

bronchoscope 102.

Referring to FIG. 3, one illustrative embodiment of an actively triggered securing system 104 is shown. The active securing system 104 can be triggered to fix the device 102. In this embodiment, a fixation clamp 202 secures the position of the bronchoscope or device 102 with respect to the patient' s anatomy, via integrating an active clamping mechanism (securing system 104) with a patient's mouth guard 204. An activation cable 206 may be provided to carry a control signal or force to activate the securing system 104 (e.g., pneumatic cable, electrical wire, etc.). The securing system 104 can be mounted on the mouth guard 204, on a trans-nasal guard or other apparatus. The clamp 202 can be implemented with different mechanisms and actuation methods as described herein.

Referring to FIG. 4, in one embodiment, a pneumatic cylinder 302 may be employed. The cylinder 302 may be controlled by a valve or valves 304 and is used to drive linear stroke motion of the cylinder 302. A foot switch 306 may be employed to control the direction of the valve 304 to regulate the air cylinder motion. In one state of the foot switch 306, the clamp (104) would be in "release mode" allowing the bronchoscope 102 to freely translate and rotate with respect to the patient. In a second state of the foot switch 306, the clamp 104 would be in "clamp mode" where the clamp would actively restrict the bronchoscope 102 from moving and/or rotating. Other states may include translation without rotation, or rotation without translation.

The cylinder 302 drives a rod or ram 316, which is advanced and retracted in accordance with the cylinder pressure as controlled by the foot switch 306 or other hands free mechanism. The cylinder 302 is mounted to a frame 312, in this example a ring-shaped frame, although other shapes are contemplated. The rod 316 supports an engagement portion 314, which can be configured for a specific device or devices or may include rubber or another soft material to adapt to the device 102. A corresponding anvil portion 308 is mounted in the frame 312 and may also be configured for a specific device or devices or may include rubber or another soft material 310 to adapt to the device 102.

It should be understood that the frame 312 or other features may be configured to receive more than one securing system 104 and be employed to secure more than one tool or scope. The additional securing system (104) may include its own control module 110 or share a control model with another securing system 104. In addition, the frame 312 may include features (clips, holes, hooks, etc.) to passively hold or support additional instruments to further assist a user during a procedure.

Referring to FIG. 5, in another embodiment, electronic actuation is employed to activate the clamp 104 instead of the hydraulic cylinder 302 depicted in FIG. 4. In one embodiment, a solenoid or other electrically actuated device 402 is employed to drive a plunger or ram 404. In one example, a solenoid 402 includes an electromagnetic coil (not shown) with a plunger 404. When the coil is energized, a force is imparted on the plunger 404. The solenoid 402 and plunger 404 can be used to electronically generate the force needed to secure the bronchoscope 102 in place as a direct replacement for the pneumatic cylinder 302 and the rod 316 in FIG. 4.

It should also be understood that other technologies and materials may be employed for electronic actuation. For example, piezoelectric actuators, motor-controlled gears, etc. may also be employed for clamping, restraining or securing.

Referring to FIG. 6, another embodiment may employ a frictional wheel assembly 502 for a bronchoscope securing system 104. The assembly 502 may include two or more wheels including a clamping wheel 504 and a controlled wheel 506. One of the wheels 504 or 506 preferably includes a compliant material or may be spring loaded to prevent damage to the bronchoscope 102, which is disposed between the wheels 504, 506 for advancement or retraction. The frictional wheel assembly 502 is applied to the bronchoscope 102 to couple the rotation of the frictional wheel(s) 504, 506 to linear motion of the bronchoscope 102. The control of the rotation (including restrictive motion) of the frictional wheels 504, 506 can be used to secure the insertion depth and rotation of the bronchoscope 102. The controlled wheel 506 can be controlled by a controller 508, which can be carefully tracked and control the rotation of wheel 506 and therefore, the bronchoscope 102. Controller 508 may include, e.g., an encoder/motor device. Tracking of the wheel rotation can be used to estimate bronchoscope insertion depth, in addition to actively controlling the wheel to impart motion or force control. The frictional wheel assembly 502 acting as a clamp or fixation device is particularly relevant to robotic applications.

Referring to FIG. 7, in one embodiment, a support arm 602 may be employed to support the securing system 104 and assist in support or positioning of other devices and equipment, for example, for supporting a portion of the bronchoscope 102. In one embodiment, the support arm 602 includes a patient bedrail attachment 604 with an adjustable armature 606 that locates the bronchoscope body clamp or securing system 104 at a correct or desired position. The adjustable armature 606 may include an ergonomic portion 608 for interfacing between a subject and the securing system 104.

Due to the bimanual nature of operating a conventional bronchoscope, whenever a clinician performs bronchoscopic navigation or intervention, the clinician is typically required to perform another task and must hand off control of the bronchoscope to another person or withdraw the bronchoscope from the patient. Therefore, conventional bronchoscopic procedures require multiple people for proper performance. Whether the clinician hands are on or off the bronchoscope, preparation of the procedural materials needs to be done. In conventional systems, an additional person (assistant) is required for the same amount of time as the clinician during the procedure.

In accordance with the present principles, the bronchoscope position can be fixed and remain within the clinician's control, but not requiring the clinician's hands. This significantly reduces the amount of assistance needed from other people. In addition, by making the engagement of this fixation system active and reactive, the system can be triggered by a software system that can react in a preset manner to conditions that may arise and be potentially harmful to the patient.

The support arm 602 is targeted to be easily maneuvered to adjust the position of the clamp/securing system 104 with respect to an entry point of the patient 130 and then can easily be locked in place. The adjustable or positioning armature arm 606 of the arm 602 may be configured to secure the bronchoscope handle to conveniently support the bronchoscope during a procedure. While the support arm 602 is illustratively depicted, it should be noted that this is merely one example of such a support mechanism, there are many styles of kinematic chains which could accomplish positioning of the securing system 104 at the entry point including, e.g., six degree of freedom (6 DOF) serial linkages, etc.

The arm 602 can be positioned or can be released for compliant placement of the securing system 104, which may include a bronchoscope body holder 609, and locked into place once the desired position has been achieved. The bronchoscope body holder 609 may include a flat, a clamp, a hook or other element and may be included to dock the handle of the bronchoscope 102. When the bronchoscope body is secured by the holder 609, the clinician can use both hands for other tasks while maintaining control of the bronchoscope 102.

The present principles may be employed with or for any bronchoscopy or endoscopic procedure where a clinician has multiple tasks to perform. The present principles are particularly useful where a clinician is forced to use assistants, especially where such procedures involve more than just navigation and visual inspection (e.g., any form of interventional, biopsy, or therapeutic procedure is performed).

Referring to FIG. 8, a block/flow diagram shows a workflow for navigating a bronchoscope in accordance with illustrative embodiments of the present principles. In block 702, a bronchoscope or other scope is passed through a clamping or securing system in accordance with the present principles and navigated to a position is accordance with a procedure or plan. A target region is reached. In block 704, the clamping system is engaged to fix the scope for one or more degrees or freedom. The fixation of the clamping system is preferably carried out by a hands-free device (e.g., a foot pedal, speech recognition, etc.). In this way, the fixation and procedural tasks may be carried out by a single person without the need for assistance by an assistant. In block 705, feedback is received from one or more sensor devices to assist the clinician. Such feedback may include insertion depth, insertion forces, haptic feedback, etc.

In block 706, tools are prepped for the procedure. The tool prepping may be carried out by the clinician without the need for assistance since the scope or device is actively fixed in position. In block 708, the procedure tasks are performed. In block 710, the scope or device is disengaged from the clamping system for removal. In block 712, the procedure is continued by repositioning and fixing the scope or device in a next region.

Referring to FIG. 9, a block/flow diagram shows a workflow for fixation of a device in accordance with illustrative embodiments of the present principles. In block 802, a device, such as a bronchoscope (or other scope or navigated instrument), is passed through a clamping or securing system mounted in proximity of an orifice of a subject. In block 804, the device is positioned to reach a target region through the orifice. This may include the use of feedback as described herein. In block 805, positioning the device may include adjusting a support armature for adjustably mounting the clamping mechanism relative to the orifice.

In block 806, an active clamp of the clamping system is activated to restrain the device in accordance with at least one of sensor feedback or a control device activated by a user. Restraining the device may include restraining one or more degrees of freedom of the device. In block 807, activating the active clamp of the clamping system may include activating one or more of a pressure driven rod, a friction wheel system, an electrically actuated system or other mechanism employed to clamp the device.

In block 809, activating the active clamp by the user may include activating the active clamp using a hands-free device to free the hands of the user to enable other tasks by the user. The hands-free device may include a foot switch, a software application, such as voice or gesture recognition software, etc.

In block 812, feedback is provided to at least one of a control module or the user regarding a status of device-to-subject interaction. In block 814, the feedback may include determining whether the device should be restricted based upon sensor measurements and criteria, e.g., at least one of force or position criteria. This may include a threshold for force or positional limits which should not be exceeded based on anatomy, safety of the patient, user preference, etc. In block 816, haptic feedback may be provided to assist the user in navigating the device. The amount of vibrational feedback may be made proportional to any number of parameters and conditions, e.g., force or positional limits which should not be exceeded based on anatomy, safety of the patient, user preference, etc.

In block 820, procedural tasks are performed with the device fixed. After the needed tasks are complete, the securing or clamping mechanism is deactivated (released). In block 822, the procedure can continue with the moving of the device to a new location/target or the removal of the device from the orifice.

In interpreting the appended claims, it should be understood that:

a) the word "comprising" does not exclude the presence of other elements or acts than those listed in a given claim;

b) the word "a" or "an" preceding an element does not exclude the presence of a plurality of such elements;

c) any reference signs in the claims do not limit their scope;

d) several "means" may be represented by the same item or hardware or software implemented structure or function; and

e) no specific sequence of acts is intended to be required unless specifically indicated.

Having described preferred embodiments for integrated active fixation system for scope navigation (which are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons skilled in the art in light of the above teachings. It is therefore to be understood that changes may be made in the particular embodiments of the disclosure disclosed which are within the scope of the embodiments disclosed herein as outlined by the appended claims. Having thus described the details and particularity required by the patent laws, what is claimed and desired protected by Letters Patent is set forth in the appended claims.

Claims

CLAIMS:

1. A fixation system, comprising:

a securing system (104) mountable in operative proximity to a subject and configured to receive a device (102) to be navigated inside an orifice of the subject;

a control module (1 10) coupled to the securing system and configured to activate an active restraint of the securing system to restrain the device in accordance with at least one of sensor feedback or a control device activated by a user; and

a feedback system (106) configured to provide information to at least one of the control module or the user regarding a status of device-to-subject interaction.

2. The fixation system as recited in claim 1, wherein the securing system (104) includes a pressure driven rod employed to clamp the device.

3. The fixation system as recited in claim 1, wherein the securing system (104) includes a friction wheel system employed to restrict the device.

4. The fixation system as recited in claim 1, wherein the securing system (104) includes an electrically actuated system employed to clamp the device.

5. The fixation system as recited in claim 1, wherein the control module (110) monitors feedback to determine if the device should be restricted based upon at least one of force or position criteria.

6. The fixation system as recited in claim 1, wherein the feedback system (106) includes one or more of a force sensor or a position sensor.

7. The fixation system as recited in claim 1, wherein the feedback system (106) includes haptic feedback to assist the user in navigating the device.

8. The fixation system as recited in claim 1, wherein the control device (1 10), activated by the user, includes a hands-free device.

9. The fixation system as recited in claim 1, further comprising a support armature (124) or adjustably mounting the securing mechanism relative to the orifice of the subject.

10. A fixation sy stem, compri sing :

a processor (1 14);

memory (1 16) coupled to the processor;

a securing system (104) configured to receive a device (102) to be navigated inside an orifice of a subject;

a control module (122) included in the memory, the control module being configured to activate an active restrictive element of the securing system to restrain the device in accordance with at least one of sensor feedback or a control device activated by a user; and a feedback system (106) configured to provide information to at least one of the control module or the user regarding a status of device-to-subject interaction, the feedback system including a display (138) for displaying feedback information to the user.

1 1. The fixation system as recited in claim 10, wherein the securing system (104) includes at least one of a pressure driven rod, a friction wheel system, and an electrically actuated system.

12. The fixation system as recited in claim 10, wherein the feedback system (106) includes one or more of a force sensor or a position sensor and the control module monitors feedback to determine if the device should be restricted based upon at least one of force or position criteria.

13. The fixation system as recited in claim 10, wherein the feedback system (106) includes haptic feedback to assist the user in navigating the device.

14. The fixation system as recited in claim 10, wherein the control module (122), activated by the user, includes a hands-free function.

15. The fixation system as recited in claim 10, further comprising a support armature (124) for adjustably mounting the securing mechanism relative to the orifice of the subject.

16. A method for fixation of a device, comprising:

passing (802) a device through a securing system mounted in proximity of an orifice of a subject;

positioning (804) the device to reach a target region through the orifice;

activating (806) an active element of the securing system to restrain the device in accordance with at least one of sensor feedback or a control device activated by a user; and providing (812) feedback to at least one of a control module or the user regarding a status of device-to-subject interaction.

17. The method as recited in claim 16, wherein activating (806) the active element of the securing system includes activating one or more of a pressure driven rod, a friction wheel system, an electrically actuated system employed to restrict the device.

18. The method as recited in claim 16, wherein providing (812) feedback includes determining (814) if the device should be restricted based upon at least one of force or position criteria.

19. The method as recited in claim 16, wherein providing (812) feedback includes providing (816) haptic feedback to assist the user in navigating the device.

20. The method as recited in claim 16, wherein activating (806) the active element by the user includes activating the active element using a hands-free device to free the hands of the user to enable other tasks by the user.

21. The method as recited in claim 16, wherein positioning (804) the device includes adjusting (805) a support armature for adjustably mounting the securing mechanism relative to the orifice.