1. Field of the Invention
The present invention generally relates to catheters, which are introduced into a biological duct, blood vessel, hollow organ, body cavity, or the like, during a medical procedure. More particularly, the present invention relates to catheters that employ one or more RF antennas to improve the visibility of the catheter and the surrounding tissue for various diagnostic and/or therapeutic purposes in an MRI environment.
2. Discussion of the Related Art
Catheters have long been used for the purpose of providing localized therapy by advancing a surgical tool (e.g., a needle, suturing device, stent or angioplasty balloon, delivering drugs, biological materials, etc.) through surrounding anatomy (e.g., the lumen of a blood vessel) to a desired, target area (e.g., a blood vessel occlusion). However, advancement of the catheter requires constant monitoring to ensure that the catheter is advanced through the surrounding anatomy, without kinking, causing injury or failing mechanically. These interventional procedures are often guided by x-ray fluoroscopy imaging.
However, there are a number of limiting characteristics associated with conventional X-ray imaging. X-ray imaging is a 2D projection imaging and cannot identify tortuosity of vasculature. Also, soft tissue visualization by x-ray imaging is not possible. First, conventional X-ray does not provide a full and complete visualization of the vascular geometry. Specifically, X-ray only visualizes a vascular lumen, and only when filled with radiographic contrast. X-ray does not provide an image of the occluded portion of a blood vessel since the contrasting agent injected into the vasculature does not penetrate the occluded segment of the blood vessel. X-ray never visualizes the external (adventitial) border or contour of a vessel. As such, the practitioner does not know the geometry of the occluded portion of the blood vessel. In addition, conventional X-Ray only provides a two dimensional projections. Another limiting feature associated with conventional X-Ray is its inability to provide cross-sectional images of the vasculature. Still another less desirable feature is the exposure of the patient to potentially harmful X-Ray radiation.
Unlike conventional X-Ray, MRI's excellent soft tissue contrast is very capable of providing full and complete images of the vasculature geometry in two or three dimensions, including the outer contour and any occluded portion thereof. Furthermore, MRI can provide multiplaner imaging e.g. axial, sagittal and coronal images, which may enable the accurate guidance of interventional procedures.
Thus excellent soft tissue contrast and multiplaner imaging capability of MRI will enable superior anatomical imaging, however, conventional commercially available interventional devices cannot be visualized in an MRI environment and may not be safe to use in an MRI environment for safety concerns (e.g. RF heating, ferromagnetic issues). Interventional devices may be made visible in an MRI environment by incorporating susceptibility artifacts creating materials in the catheters or by incorporating RF antennas in the catheters. Examples of such devices can be found, for example, in U.S. Pat. No. 5,699,801 and co-pending patent application Ser. No. 10/769,994, the contents of which are incorporated herein by reference. However, there is an ongoing need to further improve the visibility of such devices within the surrounding anatomy to better assist the practitioner.
The present invention provides various catheter configurations which incorporate one or more RF antennas to improve the visibility of the catheter and the surrounding anatomy in an MR image. In one configuration, the catheter incorporates one or more loop antennas. In another configuration, the catheter incorporates a loopless antenna. In yet another configuration, the catheter incorporates one or more loop antennas and a loopless antenna. The specific configurations described below provide brighter, more clearly distinguishable signals within the MR image that can be used to better visualize the interventional devices and enable navigating through blood vessels.
Accordingly, one advantage of the present invention is improved MR guidance by providing MR images in which the position of the catheter is more clearly distinguishable in relation to the surrounding anatomy. For example, the present invention provides guide catheters that are visible in MR images along the length of the catheter, and whereby the distal end of the catheter has enhanced visibility in MR images. This is important in vascular procedures such as chronic total occlusion recanalization, in which enhanced visualization helps prevent inadvertent perforation of the blood vessel wall.
Another advantage of the present invention is improved MR guidance by providing MR images in which a distal section of the catheter tip is clearly distinguishable in the surrounding anatomy.
Still another advantage of the present invention is improved MR guidance by providing MR images in which at least a substantial portion of the catheter, including the tip and the shaft of the catheter are clearly distinguishable within the MR image.
In accordance with a first aspect of the present invention, the aforementioned and other advantages are achieved through a guide catheter, which comprises a loop antenna disposed at the distal end of the guide catheter, and a loopless antenna disposed on the guide catheter.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the invention as claimed.
The accompanying drawings, which are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description serve to explain the principles of the invention.
The present invention involves the use of an inductor loop coil in conjunction with a guide catheter such that the inductor loop coil (hereinafter “coil”) acts as an antenna that is matched and tuned to the Larmor frequency of MRI (0.25 Tesla-11 Tesla). This antenna receives RF signal from the surrounding tissue generated in response to external RF energy applied by the MRI system, which the MRI system subsequently detects and displays in MR images.
As used herein, “microcoaxial cable” refers to a cable having an inner conductor and a shield, wherein the cable has a diameter that makes it suitable for minimally invasive medical use, such as in a catheter.
In a particular embodiment, the loop coil has an approximate length of between 0.5-50 cm, and a diameter of about 0.25-15 mm, with a pitch 140 (distance between each turn of the coil) of about 0.05 to 10 mm. The loop wire 122 may be made of a non-magnetic conductive wire, such as copper, gold, gold-platinum, or platinum-iridium. The loop wire 122 should be non-magnetic in order to prevent susceptibility artifacts in acquired MR imagery. One end of the loop wire 125 is connected to the inner conductor 122 of the microcoaxial cable 120, and the other end is connected to the shield 130 of the microcoaxial cable 120.
The loop coil 145 should be formed as close as possible to the distal end of the guide catheter 100, such as within 0.01 mm of the distal end. The loop coil 145 may be wound such that loop wire 122 coils in a direction toward the distal end of catheter 100, or it may coil in a direction toward the proximal end. The loop coil 145 may be coated with a thin polymeric insulation to prevent the loop coil 145 from in contact with body fluids. Although
The guide catheter 100 preferably includes a bend having a bend angle θ, which substantially enables an operator to steer the guide catheter 100 within a vascular structure by rotating and steering. The bend angle θ may be between about 20° and about 90°. In a particular embodiment, the bend angle θ is approximately 30°. Alternatively, single loop coil guide catheter 100 may have no such bend, in which case the single loop coil guide catheter 100 may by a deflectable tip catheter, wherein the distal end of the catheter is capable of deflection in one or more directions.
As stated, multiple coil guide catheter 200 includes a second loop coil 225, which is formed of a second coil wire 217. One end of second coil wire 217 is connected to the inner conductor 216 of the second coaxial cable 210, and the other end is connected to the shield 220 of microcoaxial cable 210. Loop coils 145 and 225 may be in close proximity to each other and separated by a distance of 1 mm or more.
In a particular embodiment, length 240 is approximately equal to the diameter of the guide catheter shaft (or the diameter of the coil 230a, 230b, or 230c) so that each coil 230a-c may appear as a “square” feature in MR imagery. Thus, image processing software can more easily determine the centroid corresponding to each of loop coils 230a-c. Loop coils 230a-c may be evenly spaced from each other by distance 235. This in turn makes it easier for the image processing software to determine the distances between the centroids of each of the coils and compare them with the known distance 235. This may be useful for various reasons. For example, if the image processing software determines that two centroids are considerably closer together than known distance 235, it may be because the guide catheter 200 is buckling or is kinked.
Loop coils 230a-c may have as tight a pitch as possible in order to maximize RF flux impinging on each of the coils by having as many turns as possible within length 240.
In the exemplary embodiment illustrated in
In an alternate embodiment, the inner conductor 125 may be substantially straight. In this case, the inner conductor may be similar to a standard dipole.
The loopless antennas described above may be formed of an inner conductor 125 of a microcoaxial cables, or may be formed of separate nonmagnetic conducting material that is connected to the inner conductor 125.
The microcoaxial cables 456, 458, and 460 are connected at the proximal end to matching tuning circuitry which matches and tunes the output of the antennas to the Larmor frequency (used in MRI) and decouples the output of the antennas during RF transmit by the MRI scanner.
For purposes of illustration, hybrid guide catheter 450 has two loop coils 462 and 464. It will be readily apparent to one of ordinary skill that one loop coil or multiple loops coils are possible and within the scope of the invention.
In hybrid guide catheter 450, the inner braid 454 and the outer shield braid 452 form a loopless antenna 457, in which the inner braid 454 serves as the positive conductor of the loopless antenna, and the outer shield braid 452 serves as a shield.
The mechanical characteristics of the inner braid 454 and the outer shield braid 452 offers the advantage of efficiently transferring torque from the proximal end to the distal end of hybrid guide catheter 450, and substantially evenly distributing axial forces along its length (i.e., “pushability”). These mechanical characteristics are desirable in any guide catheter in that they affect an operator's ability to steer the distal end of the hybrid guide catheter 450 during procedures in which precise steering of the guide catheter 450 is required, such as in chronic total occlusion recanalization and other vascular interventions. In chronic total occlusion recanalization, precise steering of a guide catheter is required to, among other things, prevent inadvertent perforation of a blood vessel wall.
The presence of RF chokes 472 prevents an RF standing wave from occurring along the guide catheter 470, which may cause RF-induced heating of the guide catheter 470. This, in turn, could pose a sefety hazard for the patient. This is particularly important for long guide catheters, for example, guide catheters that are longer than 50 cm. Accordingly, RF chokes 472 may enhance the safety of the guide catheter 470 by substantially preventing RF heating of the catheter in an MRI environment.
RF antenna configuration 505 includes a straight loopless antenna, which is described above. The inner conductor 125 of the microcoaxial cable 120 extends beyond the shield 130 of the microcoaxial cable 120, preferably by a distance of λ/4, where λ is the RF wavelength to be received by the RF antenna configuration 505. The MRI visibility curve, and thus the sensitivity of the antenna, corresponds to a current density induced within the inner conductor 125 in response to RF energy of wavelength λ impinging on the inner conductor 125. Since the loopless antenna is not an inductor loop, there is no net current flow; therefore the current density (and thus the MRI visibility) is substantially zero at the distal end of the inner conductor 125, as illustrated.
MRI visibility curve 510 may represent the sensitivity of loopless antenna 457 formed by the inner braid 454 and the outer shield braid 452 of hybrid guide catheters 450 and 470.
RF antenna configuration 515 corresponds to the forward-coiled loopless guide catheter 300, which is described above and illustrated in
RF antenna configuration 525 corresponds to the rearward-coiled loopless guide catheter 350 illustrated in
RF antenna configuration 535 corresponds to single loop coil guide catheter 100 illustrated in
RF antenna configuration 545 corresponds to hybrid guide catheter 400 illustrated in
The guidewire 600 may have an overall length of about 120 cm, with 40 cm of that distance constituting the distal section of the guidewire 600. The distal section of the guidewire 600 may be made flexible by heat treating it at 450° C. for 90 minutes. The shield 605 may be made of Nitinol, although other non-ferrous flexible conductive materials may be used that have mechanical characterics, such as the ability to efficiently transfer torque and equally distribute and transfer axial torque (i.e., “pushability”). The shield 605 may be in the form of a tube or a closely wound coil. Further, the distal section may also be a closely wound wire instead of a tubing. The insulator 620 and 625 disposed on inner conductors 620 and 625 may include FEP (fluorinated ethylene propylene).
Loop coil 640 is formed of inner conductor 610, which is connected to the shield 605 at the other end of its loop. Loop coil 645 is formed of inner conductor 615, which connects to the shield 605 at the other end of its loop. Both inner conductors 610 and 615 may include materials such as pt-ir, gold-ir, and MP35N. Loop coils 640 and 645 may each have a length between about 0.2-10 cm. between In a particular embodiment, loop coils 640 and 645 respectively have a length 650 and 655 of less than about 0.5 cm and are spaced apart by a distance 660 about 0.5 cm, although distance 660 may be as high as 1 cm.
Although guidewire 600, as illustrated in
If coil 640 is configured as a loopless coil, inner conductor 610 terminates without being connected to shield 605. In this case, both the coil 640 and the inner conductor 610 will behave as an RF antenna, which may be represented by MRI visibility curve 530 illustrated in
Guidewire 600 may employ braids and RF chokes in a manner substantially similar to guide catheters 360 and 370 respectively illustrated in
Any of the above configuration of guidewire 600 may be used with any of the guide catheters described above. However, the configuration of guidewire 600 with the loop coil 640 may be preferable in that it may be less prone to RF coupling with the coils on the guide catheter.
Accordingly, the susceptibility artifact markers 700 may serve as passive fiducial markers whereby the position and curvature of the guide catheter may be determined in the MR imagery. These markers may supplement the coils described above in providing MR imagery of the guide catheter. Further, the passive nature of the susceptibility artifact markers 700 may provide as a reliable “backup” for identifying the guide catheter in MR imagery in the event of coil failure, for example, a break in a microcoaxial cable or a failure in an impedance matching circuit.
Guide catheter 805 may be any one of the exemplary guide catheters described above. Each coil in the guide catheter 805 may be connected to a corresponding matching circuit 840. The matching circuit 840 matches and tunes the output of the coils on the guide catheter and the guidewire to the Larmor frequency (used in MRI). The matching circuit also includes a decoupling circuit, which detunes each coil during RF transmit by the RF source 812. The matching circuit may be incorporated on the guide catheter 805 or may be housed separately. The matching circuit includes a separate circuit for each individual coil in guide catheter 805.
The data system 835 may include one or more computers that may operate remotely over a network. The software may be stored and executed on the data system 835 or may be stored and executed in a distributed manner between the data system 835 and the user interface 845.
The user interface 845 may include a workstation that is connected directly to the data system 835 or may include computers that are remotely located and connected over a network. It will be apparent to one skilled in the art that many data system and user interface configurations are possible and within the scope of the invention.
The blood vessel 820 may be visible in each image, as illustrated in
It will be apparent to those skilled in the art that various modifications and variation can be made in the present invention without departing from the spirit or scope of the invention. Thus, it is intended that the present invention cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.
This application claims the benefit of U.S. Provisional Patent Application No. 60/572,038 filed on May 18, 2004, which is hereby incorporated by reference for all purposes as if fully set forth herein.
The research and development effort associated with the subject matter of this patent application was supported by the NIH Division of Intramural Research under Z01-HL005062-01 CVB and HL57483.
Number | Date | Country | |
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60572038 | May 2004 | US |