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[0001] This Application is a divisional application of U.S. patent application Ser. No. 09/211,723, filed Dec. 14, 1998, (incorporated herein by reference), which claims priority of Provisional Patent Application Ser. No. 60/107,144 filed Nov. 3, 1998, (incorporated herein by reference).
[0002] This invention relates to a magnetic surgery system, and in particular to an open magnetic surgery system that provides greater access to the patient for imaging and other purposes.
[0003] A wide variety of minimally invasive surgical procedures have been developed which employ catheters, endoscopes, or other similar devices that can be navigated remotely from their distal ends. The catheter, endoscope or other medical device is manipulated through the tissue or through an existing body lumen or cavity using a guide wire or other mechanical means. Examples of such procedures include the treatment of aneurysms, arterial ventricular malformations, atrial fibrillation, ureteral stones, and investigations of lumen such as sigmoidoscopies and colonoscopies, ERCP's; and biliary duct examinations. While these procedures are highly beneficial to the patient, they are difficult and time consuming for the physician. Some procedures can only be performed by the most skilled surgeons.
[0004] Several attempts have been made to use magnets to assist in such surgeries, as documented in “A New Magnet System for “Intravascular Navigation’,” Shyam B. Yodh et al., Med. And Biol. Engrg., Vol. 6, pp. 143-147 (1968); “Magnetically Controlled Intravascular Catheter,” John Alksne, Surgery, Vol. 61, no. 1, 339-345 (1968); “The ‘Pod’, a New Magnetic Device for Medical Applications,” E. H. Frei et al., in Proceedings of 16th Ann. Conference on Engineering in Medicine and Biology, Vol. 5, Nov. 18-20, 1963, pp. 156-157; “Magnetic Propulsion of Diagnostic or Therapeutic Elements Through the Body Ducts of Animal or Human Patients,” U.S. Pat. No. 3,358,676, issued Dec. 19, 1967 to E. H. Frei et al.; “Selective Angiography with a Catheter Guided by a Magnet,” H. Tillander, IEEE Transactions on Magnetics, Vol. Mag-6, No. 2, 355-375 (1970); and “Cerebral Arterioveneous Malformations Treated with Magnetically Guided Emboli,” Jack Driller et al., in Proc. of 25th Ann. Conf. On Engineering and Biology, Vol. 14 (1972), p. 306.
[0005] For various reasons these previous attempts at magnetically assisted surgery have not proven to be successful, nor are they widely used. One reason has been the inability of the previous systems to adequately guide the probes within the vessels, partly for mechanical and hydrodynamic reasons, partly from the lack of adequate computer and control technology, and partly because of an inability to provide adequate real time imaging for the procedures. Because of the small size of the vessels to be navigated, extremely high resolution and flexibly moveable fluoroscopes are needed to provide adequate imaging. These fluoroscopes are large instruments. Even now, accessibility of adequate imaging in the presence of the large magnets needed to move small magnetic guiding “seeds” on medical devices is difficult.
[0006] Systems have been disclosed for magnetic guidance of catheters and guidewires to facilitate navigation of difficult vascular turns. An example of such a system is provided in U.S. utility patent application Ser. No. 09/020,934, filed Feb. 9, 1998, entitled “Method and Apparatus Using Shaped Field of Repositionable Magnet to Guide Implant,” incorporated by reference herein in its entirety. Other effective magnetic surgical systems have required relatively large magnets. Often, superconducting magnets with associated cooling systems are used to generate the most effective magnetic fields, and two magnets for each spatial direction have been provided for a total of six magnets, each having an associated cooling system. Such a system is disclosed in U.S. patent application Ser. No. 08/920,446, filed Aug. 29, 1997, entitled “Method and Apparatus for Magnetically Controlling Motion Direction of a Mechanically Pushed Catheter,” incorporated by reference herein in its entirety.
[0007] Imaging means can be used in conjunction with magnetically guided surgery. An example of such a system is described in U.S. utility patent application Ser. No. 09/020,798, filed Feb. 9, 1998, entitled “Device and Method for Specifying Magnetic Field for Surgical Applications,” incorporated by reference herein in its entirety. While magnetically guided surgery with such systems is practical, the sheer bulk and size of their magnetic systems results in less accessibility of the operating region of the patient than a surgeon might prefer. Also, imaging equipment (such as X-ray equipment) for observing the operating region has been fixed to the magnetic system assembly, or otherwise been immobile or of limited mobility relative to the magnets and/or the patient. This relative immobility tends to reduce the ability of the surgeons to see the medical operating device in the patient, making the operation somewhat more difficult for the surgeon and somewhat riskier for the patient than might otherwise be the case. Another difficulty with using magnetic systems for these purposes is that the conventional fluoroscopes cannot be used in magnetic fields of any significant magnitude. It would therefore be desirable to provide an apparatus for magnetically-assisted surgery that provides flexibility of both the imaging and of the magnetic field application.
[0008] A difficulty associated with magnetic guidance is that relatively large magnetic fields are needed to guide the small magnets that can fit within the small vessels and body lumens. The large superconducting coils employed in previous systems to provide these relatively large magnetic fields put huge amounts of energy into the fields. Because of the tendency for the coils to quench if ramped (powered) up or down too rapidly, the rate at which current can be applied or removed from the coils is limited, even with advantageous ramping methods such as the “constant power ramp.” See U.S. patent application Ser. No. 08/921,298, filed Aug. 29, 1997, entitled “Method and Apparatus for Rapidly Changing a Magnetic Field Produced by Electromagnets,” incorporated by reference herein in its entirety. The distance between the coil and the operating region is also a factor in ramping time, and thus it is desirable to provide a system having coils located and sized so as to optimize both the “openness” described above in terms of the accessibility to the surgeon of an operating region of a patient, and the rapidity of field directional changes.
[0009] Unless otherwise noted, all referenced issued patents, patent applications, and other documents are hereby incorporated by reference in their entirety.
[0010] The present invention provides an open system for navigating a magnetic medical device within that part of a patient located within an operating region of the system. Generally, the system comprises a plurality of magnets configured and arranged to provide a magnetic field effective within the operating region to navigate the magnetic medical device within the operating region, while providing access to the patent for imaging and other purpose.
[0011] The magnets are preferably electromagnetic coils, and more preferably superconducting electromagnetic coils. The magnets are preferably capable of generating a magnetic field of at least about 0.1 Tesla in an operating region of at least about two inches by two inches by two inches, and more preferably in an operating region of at least about five inches by five inches by five inches. In a preferred embodiment, the magnets can generate a field of about 0.3 Tesla in any direction within the operating region. The operating region is preferably at least about twelve inches from each of the magnets, such that the system can accommodate a sphere having a radius of about twelve inches to provide sufficient room for a patient and imaging apparatus.
[0012] Generally, a single magnet is arranged and configured to provide a magnetic field along at least one of a plurality of oblique axes extending through the operating region, and one or more magnets are arranged and configured to provide a magnetic field along each of the other of said oblique axes, said magnetic fields being effective to controllably navigate the magnetic medical device within substantially the entirety of the operating region. Preferably there are three magnets in three mutually perpendicular planes, arranged such that their axes converge in the operating region, and more preferably they are arranged so that their axes intersect in the operating region. The magnets are arranged in an open configuration, i.e., the patient typically does not have to extend through a magnet coil to reach the operating region, as was required in previous magnetic surgery systems. The coils are sized and positioned so that their respective near field lines are substantially straight within the operating region.
[0013] The coils are preferably fixed relative to each other, but may be moveable relative to the patient. The magnets are preferably enclosed within a concave housing sufficiently large to accommodate the patient and imaging devices, yet small enough to fit within the conventional supports for imaging devices. In the most preferred embodiment, the shell has a generally hemispherical shape, with an inner diameter of at least about twenty-four inches and an outer diameter of no more than about fifty inches. The generally hemispherical shell is mounted so that its axis is at an angle between vertical and horizontal and thus faces generally downwardly, but so that the shell can be rotated about a generally vertical axis.
[0014] To increase the flexibility of the system, there is preferably an opening in the housing, aligned with one of the coils, through which a portion of the patient's body can extend to bring another portion of the patient's body into the system's operating region. The system can include a patient support for supporting and for moving the patient relative to the operating region of the system.
[0015] The system further comprises an imaging system for providing images of the operating region. The imaging system comprises at least one, and preferably two imaging devices. Each imaging device comprises an imaging plate and an x-ray imaging source. The imaging plates are preferably ones that are minimally affected by magnetic fields, such as amorphous silicon imaging plates. The imaging devices are preferably fixedly mounted with respect to each other, in mutually perpendicular directions to provide perpendicular bi-planar imaging of the operating region.
[0016] The imaging devices are mounted on a movable support, independently of the magnet coils. The support allows the imaging devices to be moved about three axes, and may be, for example a conventional C-arm support. This allows the imaging devices to be moved relative to the operating region, to provide the surgeon the most advantageous view of the procedure. The three axes of movement of the imaging devices preferably intersect, and more preferably they intersect in the operating region, and most preferably they intersect at the same point where the axes of the magnets coils intersect. This provides the greatest flexibility of imaging in the operating region.
[0017] More specifically, the system of this invention provides for navigating a magnetic medical device within that portion of a patient within an operating region of the system. The system includes a support for at least a portion of the patient. The system also includes a magnet assembly including electromagnetic coils arranged and configured so that the axes of the coils converge, and a magnet mount holding the magnet assembly so that the center of the operating region (i.e., the convergence of the axes) is within the desired portion of the patient on the patient support. An imaging assembly for providing an image of the operating region comprises at least one imaging plate and an imaging beam source mounted on an imaging support to be on opposite sides of the operating region, and a mechanism for selectively pivoting the support about three mutually perpendicular axes.
[0018] In the preferred embodiment, a total of three super conducting magnets coils are configured so that each of their central axes lies generally along an axis of an orthogonal coordinate system having its origin approximately centered within the operating region. The magnets are supported by a generally hemispherical housing and each magnet is of sufficient strength to provide a magnetic field in the direction of its respective central axis having a generally consistent strength of about 0.3 Tesla throughout substantially the entirety of the operating region. A control adjusts the strength of the magnetic field of each of said magnet coils to thereby controllably navigate the magnetic medical device within that part of a patient within the operating region.
[0019] The method of navigating according to this invention includes applying a magnetic field to the magnetic medical device in the operating region with at least three electromagnetic coils contained within a magnet housing to navigate the medical device within the operating region; and providing an image of the magnetic medical device in the operating region with an imaging apparatus comprising at least one imaging plate and an imaging beam source, the imaging plate and imaging beam source being on opposite sides of the operating region, with the imaging plate being positioned between the operating region and the magnet housing. The imaging plate and imaging beam source are movable about three mutually perpendicular axes which extend through the operating region. These axes preferably extend through the point of intersection of the axes of the magnets.
[0020] The present invention also includes a method of determining a distribution of ramping times for the electromagnetic coils in the system. This method includes calculating for a selected magnetic field magnitude and direction, the currents needed in each coil to provide the selected magnetic field magnitude and direction at a point in an operating region; estimating, for each of the calculated currents, a ramping time required to reach the calculated current; and repeating the current calculating step and the ramping time estimating step for a plurality of different points in the operating region, and for selected magnetic field magnitudes and directions to obtain a distribution of ramping times as a function of selected magnetic field magnitude and direction for the system.
[0021] The present invention also includes a method of optimizing the design of the system, comprising selecting a maximum ramping time not to be exceeded by a selected percentage of navigational direction changes of the magnetic medical device; determining a distribution of ramping times; determining a percentage of ramping times in the distribution of ramping times that the selected maximum ramping time is exceeded; and modifying at least one property of at least one of the electromagnetic coils, the at least one property including at least one property selected from the group consisting of coil radius, coil cross-sectional area, coil distance from the operating region, and coil aspect ratio; and repeating the computing, determining, and modifying steps until the percentage of ramping times in the distribution of ramping times that the selected minimum ramping time is exceeded is not more than the selected percentage of navigational direction changes.
[0022] A magnetic resonance imaging system comprising an electromagnet for generating a magnetic field in the vicinity of the a body for making a magnetic resonance image of a portion of the body and an x-ray image apparatus, comprising an x-ray image source and an x-ray image plate, for making an image of the portion of the body, at least the x-ray image plate being within the magnetic field generated by the electromagnet.
[0023] Thus the system of the present invention provides for effective magnetic guidance of magnetic medical devices within the body for performing medical procedures. The system is capable of providing magnetic fields of sufficient strength for orientation and even movement of magnetic medical devices, within a sufficiently large operating region to allow practical medical procedures to be completed with magnetic assistance. However, the magnets are arranged so that the operating region of the system can be positioned in any portion of the body. The system provides open access so that imaging plates can be interposed between the patient and the magnets to provide high-quality images of the operating region. The imaging apparatus can be moved independently of the magnets to provide the best possible views of the operating region.
[0024] These and other features and advantages will be in part apparent and in part pointed out hereinafter.
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[0082] Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
[0083] A first embodiment of an inventive open field magnetic surgical system constructed according to the principles of this invention is indicated generally as
[0084] The patient support
[0085] The magnet assembly
[0086] The magnet coils
[0087] As best shown in FIGS.
[0088] The magnet coils
[0089] The magnet assembly
[0090] The magnet support
[0091] The housing
[0092] The imaging assembly
[0093] As shown in the Figures, C-arm
[0094] The C-shaped support
[0095] The C-arm
[0096] As best shown in
[0097] The magnet coils
[0098] Sizing and Locating the Electromagnet Coils
[0099] The method by which the size and location of the coils can be selected is as follows: It is to be understood that use of the same method, with different compromises or initial assumptions, may result in a system having coils of somewhat different sizes and locations, but still within the principles of this invention.
[0100] Using the Biot-Savart Law, it is possible to calculate the magnetic field everywhere for a coil having a given shape, size, and total number of ampere-turns. To arrive at the particular combination of size and location described above, the inventors started with the assumption that three coils would provide the best compromise between being too large and too close to provide a needed internal exclusion volume for imaging equipment and beams, while not being too weak to provide the needed strength in a given operating region or procedure volume inside the patient. The three coil choice follows from experience with six coil systems, and, in accordance with the invention, provides much more freedom for physicians and imaging.
[0101] The inventors also intended for the body-axis coil (coil
[0102] These qualitative requirements dictate the approximate size and shape of the three coils. If the coils are huge, they would provide great freedom for the imaging devices and for the surgeon, but the coil would be heavy, expensive and have long ramping times for field changes. If the coils are too small, they would interfere with the location and motion of the imaging plates
[0103] Added to this, the coils must be large enough, individually, that their near field lines do not bend severely in the operating region, which is centered near the intersection of their axes. Otherwise, it becomes difficult to attain the field strengths needed at the needed distances from the coils, for certain directions of the field.
[0104] An exact determination of the coil sizes and locations is achieved by iterative computer modeling in conjunction with the CAD plots. On a computer, a first trial size is chosen for the three coils of the set, and the fields are calculated at various angles and distances from the coil, assuming a current density (e.g., 14,000 Amperes per square cm) that is suitable for the superconducting coils of these strengths. From this choice, field lines and lines of equal field strength at full current for one coil (e.g., the axial coil,
[0105]
[0106] Given a target field strength requirement, e.g., 0.3 Tesla, it can be determined, from the iterative computer modeling or by some other method, whether the individual coils have sufficient strength to cover, or nearly cover, the operating region, when appropriately combined. If the coils are too strong, the ramp time and weight will be too great, and their cross section can be reduced.
[0107] Each coil supplies most of the field strength for the direction along its axis. The general requirement of small field curvature for the field lines leads to the fact that the coils act predominantly independently for each axis. That is, orthogonal coils do not contribute an operatively significant field component along the direction of the axis of the other coils in the operating region. And, curved lines fail to achieve sufficient strength along bisecting planes between coils. The total field at any location in the operating region, and at any required angle, therefore, will be, for purposes of magnetically-assisted surgery, the sum of the individual fields from each of the three coils. While this “vector sum” model which assumes straight field lines is only approximately correct, a computer can make accurate, detailed calculations of the total fields of the system with any given set of currents. A final determination of meeting field requirements in the operating region involves only modest changes from the trials just described. The final determination of coil sizes and locations, subject to the general considerations stated above, uses a computer program to calculate the magnetic fields and resultant ramping times as follows.
[0108] The operating region can be broken into small segments or “nodes,” for example, of about 20 along each side, so that a cubical-shaped operating region would have about 8,000 nodes. For about 20 random directions, in each node, the computer calculates the three coil currents needed to provide the required magnetic field strength at each direction, should the operating point be in the center of that node. Consequently, a total of 20×8,000 calculations are made to provide this sampling of the total operating region. (only two angles are needed to specify any direction in space, for example, a polar and an azimuthal angle. Therefore, there are only three unknown currents in each calculation, and the magnetic field strength and direction constitute three unknowns, so the calculation is a simple matrix solution. Information about such matrix calculations is provided in patent application Ser. No. 08/920,446, filed Aug. 29, 1997, on “Method and Apparatus for Magnetically Controlling Motion Direction of a Mechanically Pushed Catheter,” incorporated by reference herein in its entirety.
[0109] In using these calculations, it is often important to the physician in a particular application to be able to make use of a statistical statement about the distribution of coil currents, and consequently, the ramping time. For the purpose of determining the time needed for ramping, the maximum current of each set, is chosen in a sequence of turns in navigating to a target, and a model of the ramping needs is used. In one application, the essential ramping sequence has the following steps: (1) determine the previous field direction at the magnetic object location, (2) determine the desired new direction and the angle of the change, (3) using knowledge of the field needed to make a turn of this magnitude, set the new field direction and magnitude, (4) execute the new ramp, and (5) upon completion of the ramp and turn, ramp the current down.
[0110] Each of these five-step sequences can be evaluated for the total ramp-up, ramp-down time. The computer can do the estimates for each of the above-stated 160,000 cases, and perform plots of either the overall probability distribution of ramp times, or it can plot binned probabilities for turns of 0-10°, 10-20°, etc. Such plots can inform the surgeon of the time needed for a given angle of turn. And, with an intuitive display, such as a thermometer type representation on a screen, the surgeon can quickly decide whether magnetic assist is necessary or useful on any given turn, thereby increasing the efficiency and effectiveness of the overall procedure.
[0111] When the optimum compromise of coil size, location and coil power is determined, the dimensions and magnetic requirements are met, the design goes to a succeeding stage. From mechanical application of the Biot-Savart law, it is possible to calculate the stresses on each coil due to the interaction of currents in it and in the other coils. Textbooks (e.g.,
[0112] Then the three components of dF are entered into a finite element analysis program “FEA” dealing with stresses and forces, e.g. “pro/MECHANICA”®, Parametric Technology Corp., Waltham Mass., which can be used by one skilled in the art on any inputted structure supporting the three coils. An individual coil force is transmitted from its surround, a “bobbin,” to the supporting structure. In one simple but not preferred embodiment, three plates are welded together, each supporting one of the coils in the appropriate location. The results of calculation are often plotted as colored graphs, where regions of different stresses in the support structure (responding to the magnetic forces) are shown in different color. In addition, the program can determine deflections by summing reaction deflection to the stresses in individual elements of the structures. Then the designer tries different support struts which can alleviate excessive stresses or deflections in the first, simpler trial design. By an iterative process, and standard experience in mechanical design, the designer arrives at design shapes and/or structure details that minimize the overall weight of the structure, while exhibiting no excessive stresses and deflections.
[0113] In addition to the structural support and strength, the coil mounting system for superconducting systems must consider the cryogenic materials and transfer of heat and cryogens. Those skilled in the art have methods and programs to calculate heat transfer. They also have methods for most efficiently arranging insulation, vacuum spaces, intermediate heat shields, and ducting for liquid cryogen transfer, as well as cold gas exit, if the system is not recondensing and recirculating.
[0114] Several overall cryogenic systems in common practice are suitable for the practice of this invention. One such system simply uses liquid helium to cool the superconducting coils. The liquid helium evaporates and goes out as a gas. This system usually employs a 77° Kelvin shield attached to a liquid nitrogen reservoir. Another method uses a cryogenic cooler that cools an object down to the approximately 4.5° Kelvin needed to maintain superconducting wires in the superconducting state. This cryogenic cooler may either be attached solidly to the coil bobbin or it may, for flexibility, be coupled with liquid helium, which may either be totally enclosed or may need occasional replenishing. A cryogenic cooler may be used to cool a shield to intermediate temperatures. The cryogenic cooler may be attached solidly to the shield, or with a gas coupling, such as liquid neon. Cryogenic coolers have been designed to have two or more stages so as to supply more heat removing power at the higher, intermediate temperatures, and a lower cooling rate at the liquid helium temperatures. The selection of which system to use depends upon both economical and technical features, because cryocoolers are, at present, relatively expensive. Liquid helium is also expensive, however, and both space and weight are important considerations. Therefore, recirculating systems, which can be smaller and lighter, may be preferred.
[0115] As is known, the coils may have a split or two piece construction to better accommodate thermal contraction upon cooling, and to facilitate coolant.
[0116] A second embodiment of an inventive open field magnetic surgical system constructed according to the principles of this invention is indicated generally as
[0117] The patient support
[0118] The magnet assembly
[0119] The magnet coils
[0120] As best shown in FIGS.
[0121] Coils
[0122] The housing
[0123] The imaging assembly
[0124] The imaging devices
[0125] A third embodiment of an inventive open field magnetic surgery system constructed according to the principles of this invention is indicated generally as
[0126] The patient support
[0127] The magnet assembly
[0128] The magnet coils
[0129] As best shown in
[0130] Coils
[0131] The housing
[0132] An alternate construction of the magnet assembly of this third embodiment is indicated generally as
[0133] Coils
[0134] The housing
[0135] The housing
[0136] The imaging assembly
[0137] The imaging devices
[0138] The Fourth Embodiment
[0139] A fourth embodiment of an inventive open field magnetic surgery system constructed according to the principles of this invention is indicated generally as
[0140] The patient support
[0141] The magnet assembly
[0142] The imaging assembly
[0143] It should be noted that the same or a very similar magnetic and imaging equipment and arrangement may be used to provide for parenchymal navigation for neurosurgical procedures in brain tissue, such as for implanting catheters or introducing tubes in curved paths. See Werp et al., “Method of and apparatus for intraparenchymal positioning of medical devices,” App. Ser. No. 08/969,165, filed Nov. 12, 1997; “Apparatus for and Method of Controlling an Electromagnetic Coil System,” App. Ser. No. 08/682,867, filed Jul. 8, 1996; Ritter et al., “Control Method for Magnetic Stereotaxis System,” U.S. Pat. No. 5,654,864, issued Aug. 5, 1997; Howard et al., “Magnetic Stereotactic System for Treatment Delivery,” U.S. Pat. No. 5,125,888, issued Jun. 30, 1992; Howard et al., “Magnetic Stereotactic System for Treatment Delivery,” U.S. Pat. No. 5,707,335, issued Jan. 13, 1998; Howard et al., “Video Tumor Fighting System,” U.S. Pat. No. 4,869,247, issued Sep. 26, 1989; Howard et al., “Magnetic Stereotactic System for Treatment Delivery,” U.S. Pat. No. 5,779,694, issued Jul. 14, 1998; Howard et al., “Magnetic Stereotactic System for Treatment Delivery,” App. Ser. No. 09/114,414, filed Jul. 13, 1998; “Method and Apparatus for Magnetically Controlling Motion Direction of a Mechanically Pushed Catheter,” App. Ser. No. 08,920,446, filed Aug. 29, 1997; and Ritter et al., “Method and Apparatus for Rapidly Changing a Magnetic Field Produced by Electromagnets,” App. Ser. No. 08/921,298, filed Aug. 29, 1997. Further applications of the inventive apparatus include the introduction of biopsy tools, electrodes for palidotomy, or stimulators for other treatment of Parkinson's disease, and the introduction of drug infusion apparatus.
[0144] A combination of a magnetic resonance imaging device and a bi-planar imaging device is shown in FIGS.
[0145] It will be recognized by one skilled in the art that the various embodiments shown and described herein are intended to be exemplary, that many modifications may be made within the spirit and scope of the invention. It should also be clear that embodiments are possible that incorporate some, but not all, of the features of the invention, such as, by way of example only, providing fewer directions of motion for a C-arm. Such embodiments may still fall within the scope and spirit of the invention, even though achieving only some of the objectives and advantages thereof. The scope of the invention should therefore be determined from the claims, including all legal equivalents thereto, with reference to the specification and the examples and figures provided therein.