The present disclosure relates to devices and methods for interventional medicine, and more specifically to navigation of medical devices through the body to an operating region.
Interventional medicine is the collection of medical procedures in which access to the site of treatment is made through one of the patient's blood vessels, body cavities or lumens. Interventional medicine technologies have been applied to the manipulation of instruments which contact tissues during surgical procedures. Several presently available interventional medical systems for navigating an interventional medical device through a subject's lumens direct and orient the device distal tip by means of a navigation mechanism, such as magnetic navigation, using computer assisted navigation and an imaging system to provide real-time imaging of the device and blood vessels and tissues. Such systems can control the navigation of a medical device, such as a catheter, to a target destination in an operating region using a computer and controlled navigation mechanism to orient and guide the distal tip through blood vessels and tissue. To reach the target destination, a navigation system must accurately control the device tip as it approaches the target before advancing the remaining distance to reach the given target. In some cases, the device tip may not reach the desired target due to inaccuracies in the system or due to difficulties in navigating the device.
Embodiment of the present invention provides for controllably extending and retracting the distal end of a medical device that is adapted to be magnetically navigated within a subject's body. In one aspect of the present invention, a magnetically navigable medical device is provided that has a proximal end, an elongated lumen, and a distal end having an extendable and retractable tip. The distal tip element is configured to be retracted prior to advancing the distal end of the medical device near to a target area within the subject's body, and to be controllably extended towards the target area within the subject's body. An actuation means is provided for controllably extending the tip element, which enables fine control of the advancement of the tip of the medical device towards a target location within a subject's body. The actuation means can be selected from the group comprising hydraulic pressure application to an expandable volume, electrical current application to a material that responsively changes length, electrical current application to an electromagnet for responsively repelling and displacing a magnet, and mechanical force application for displacing a spring-loaded mechanism. The actuation means is either under control of a physician, or under computer control for automatic extension and retraction. In either case, feedback information is available to the user or computer in the form of real-time imaging or real-time positioning of the device distal tip with respect to the subject anatomy. Additional feedback information of use in navigation in specific embodiments include data from an ultrasound probe, contact monitoring probe, or force-sensing probe, all such probes being located at or near the distal tip element.
In another aspect of the present invention, a method for controllably advancing a medical device having a retractable and extendable tip element is provided. The method provides for controllably advancing the medical device towards a target area within a subject's body, whereby the method includes introducing the distal end of the medical device into a subject's body, and navigating the distal end towards a target area within the subject's body. The method provides for retracting the retractable tip element prior to advancing the distal end of the medical device near the target area within the subject's body, and controllably extending the tip element toward the target area. Extending the retractable and extendable tip a minute distance towards a target area can be finely controlled and achieved by at least one actuation means under physician or computer control. The fine control of the retractable and extendable tip element can be achieved by controlling an actuation means selected from the group comprising hydraulic pressure application to an expandable volume, electrical current application to a material that responsively changes length, electrical current application to an electromagnet for responsively repelling and displacing a magnet, and mechanical force application for displacing a spring mechanism, to retract and extend a tip element.
Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features.
In the various embodiments, a navigable elongated medical device having a proximal end and a distal end is provided that is adapted to be navigated through a subject's body, and to be controllably extended towards a target area within the subject's body. The elongated medical device includes an extendable and retractable tip element that is disposed on the distal end of the medical device. The extendable and retractable tip element may be finely controlled to extend the tip a minute distance, for controlling the approach of the medical device towards a target area. The medical device is adapted to be inserted into a subject's vasculature and navigated towards a target destination, such as the heart for example. The extendable tip element of the medical device is adapted to be retracted, and is preferably in a retracted state prior to advancing the distal end of the medical device to the target area. Where the elongate medical device has encountered several turns through the subject's body during navigation towards a target area, the degree of advancement control may be greatly reduced. To advance the tip with finesse, the extendable tip element is adapted to be controllably extended. The tip element may be finely controlled to extend the tip towards a target area within the subject's body that may be difficult to locate. Examples of such situations may include a tiny side vessel of the vasculature, or when the tip must be extremely near or in contact with moving heart wall tissue. In the various embodiments, the tip element is controllably contracted or extended by an actuation means selected from the group consisting of hydraulic pressure application to an expandable volume, electrical current application to a material that responsively changes length, electrical current application to an electromagnet for responsively repelling and displacing a magnet, and mechanical force application for displacing a spring mechanism.
One embodiment of a medical device 150 having a proximal end 152 and a distal end 154 is provided for use in an interventional system 100 is shown in
As shown in
In specific embodiments, device tip 156 can have sensor(s), such as strain gauges or similar devices located at or near the device tip to provide force data information to estimate the amount of pressure applied on the target tissue, as feedback to system 100 in determining the device tip extension or retraction; other sensors might include an ultrasound device or other device appropriate for the determination of distance from the device tip to the tissue. Feedback data from the tip element and the device distal end are processed by feedback block 194 which in turns communicates with the tip element control block 192 as well as with computer 110. Further device tip feedback data can include relative tip and tissues positions information provided by an imaging system, predictive device modeling, or device localization system. In closed loop implementation, the device tip control 192 provides input commands to the device tip actuation mechanism based on feedback data and previously provided input instructions; in semi-closed loop implementations, the physician also contributes to the navigation, based in part upon feedback data. Control commands and feedback data may be communicated from the user interface and control 192 to the device and from the device tip back to the feedback block 194, through cables or other means, such a wireless communications and interfaces. As known in the art, control block 192 comprises an electromechanical device advancer (not shown), capable of precise device advance and retraction based on corresponding control commands.
In another aspect of the invention, a method is disclosed that enables magnetic navigation of an interventional device to a region of operation and subsequent acquisition of diagnostic information and/or treatment of specific conditions.
If the intervention is for the acquisition of diagnostic heart information, such as in the case of planned cardiac tissue ablation for the treatment of arrhythmia in electro-physiology (EP) applications, 260, the device tip is positioned in the neighborhood of the heart wall tissue to be evaluated or treated, 262. The quasi-periodic motion of the heart wall is monitored, for example using ultrasound technology, 264, and a corresponding dynamic tip extension/retraction sequence is programmed for the device, 266. The tip is then advanced to contact the tissue with appropriate force, 268, and upon contact (as determined, for example, from a contact sensor measuring electrical currents), the quasi-periodic motion sequence is activated with the appropriate phase to match the tissue motion. If necessary, adjustments are made to the programmed quasi-periodic tip sequence so that contact pressure is maintained and remains within safe values. Then, diagnostic data are collected or treatment, such as tissue ablation, is performed, 270. Once this step is completed, the method iterates to the next selected contact point, 272, or terminates, 274. Even though only two specific applications are illustrated in this method flow-chart, other interventions are possible by application of the disclosed method.
In a first device embodiment as shown in
In a second device embodiment as shown in
In a third device embodiment as shown in
In a fourth device embodiment as shown in
In the various embodiments of a medical device described above, the tip element further comprises at least one magnetically responsive element 350 disposed in the distal end of the medical device. The magnetically responsive element 350 can be made of a permanent magnetic material or a permeable magnetic material, and is configured to provide for magnetic navigation of the distal end of the medical device. In the presence of an applied magnetic field, the distal end of the medical device will tend to align with the field direction to the extent allowed by the flexibility of the medical device. The magnetically responsive element 350 is of sufficient size and shape to cause the distal end of the medical device to align in a selected direction with a magnetic field applied from an external source magnet. Suitable permanent magnetic materials include neodymium-iron-boron (Nd—Fe—B), Suitable permeable magnetic materials include magnetic stainless steel, such as a 303 or 304 stainless steel, or other alloys such as Hiperco. Permeable magnetic materials may be used as a substitute for but preferably in combination with permanent magnetic materials. The size and material of the magnetically responsive element 350 are selected so that the distal end of the guide wire can be reoriented by the application of a magnetic field of no more than about 0.10 Tesla, and more preferably no more than about 0.08 Tesla, and more preferably no more than about 0.06 Tesla. In the preferred embodiment, the length of the magnetically responsive element 350 is preferably at least 1.0 millimeter, but may alternatively be any length in the range of 0.5 to 5 millimeters.
In another aspect of the present invention, organ motion tracking is achieved by dynamically retracting and advancing the entire device from its proximal end. Given a known device length inserted in the subject's body, and modeled transfer function relating input advancer increments to device tip travel distances, a sequence of advancer commands is programmed into device control block 192. Adjustments to the sequences are made based on feedback inputs from the device tip to the feedback processing block 194 and control block 192. In such a way, dynamic tracking of an organ is achieved by proximally advancing and retracting the entire device inserted length, without need for a separate extendable tip element.
Dynamic and adaptive organ wall motion tracking can also be achieved by other means. In one embodiment of the present invention, a device is provided with a set of pull-wires, extending from the device proximal end to various wire termination points along the device length, as known in the art. The predicted wall motion is processed by control block 192, and sequences of pull-wire retractions and releases are programmed into pull-wire servo-motors. Adjustments to the sequences are made based on feedback inputs from the device tip to the feedback processing block 194 and control block 192. In such a way, dynamic tracking of an organ is achieved by relying on the pull action of the wires acting against the device mechanical flexibility and associated recoil behavior, without need for a separate extendable tip element. Dynamic pull-wire activation sequences can be combined with dynamic proximal device advances and retraction, thereby permitting organ motion tracking with increased flexibility and over larger motion ranges than possible with either of these two approaches separately.
Either one of the embodiments just described, using proximal device advance and retraction, pull-wire activation sequences, or combination thereof, can be combined with a separately actuated device tip element extension and retraction, to achieve tracking of an organ motion over distances that might not otherwise be achievable.
These various mechanical embodiments of a device allowing organ motion tracking can also be combined with magnetic navigation. Magnetic navigation enables finer control of the device distal tip by ensuring that contact is maintained or repeated within a small area of the tissue, typically within a millimeter. Magnetic navigation also enables small controlled dynamic adjustments that might be difficult to achieve by mechanical means only, thereby providing quick response to changes in body parameters, such as heart rate, or changes in local blood flow patterns.
Although the present invention has been described with respect to several exemplary embodiments, there are many other variations of the above-described embodiments that will be apparent to those skilled in the art, even where elements have not explicitly been designated as exemplary. It is understood that these modifications are within the teaching of the present invention, which is to be limited only by the claims appended hereto.
This application claims benefit of U.S. Provisional Patent Application Ser. No. 60/793,027, filed Apr. 19, 2006, the entire disclosure of which is incorporated by reference.
Number | Date | Country | |
---|---|---|---|
60793027 | Apr 2006 | US |