WO2008007350A1

WO2008007350A1 - A tool and method for optimal positioning of a device within a tubular organ

Info

Publication number: WO2008007350A1
Application number: PCT/IL2006/000793
Authority: WO
Inventors: Didi Sazbon; Moshe Klaiman; Michael Zarkh
Original assignee: Paieon Inc.
Priority date: 2006-07-09
Filing date: 2006-07-09
Publication date: 2008-01-17

Abstract

A novel tool for real-time registration between a tubular organ and a device, and a method that utilizes the proposed tool for presenting the device within a reference model of the tubular organ are disclosed. The proposed tool or markers attached thereto, and the device are shown by one imaging modality and the tubular organ is shown by a different imaging modality, but no imaging modality shows both. Due to the usage of the proposed tool, the registration between the device and the tubular organ is significantly simplified and thus, increasing both speed and accuracy.

Description

A TOOL AND METHOD FOR ENHANCED POSITIONING OF A DEVICE WITHIN A TUBULAR ORGAN

RELATED APPLICATIONS

The present invention relates to International patent application serial number PCT/ILO 1/00201 titled "SYSTEM AND METHOD FOR THREE- DIMENSIONAL RECONSTRUCTION OF AN ARTERY" published on 15 November, 2001, to International patent application serial number PCT/IL2005/000360 titled "METHOD AND APPARATUS FOR POSITIONING A DEVICE IN A TUBULAR ORGAN" filed on 31 March, 2005, and to International patent application serial number PCT/IL2004/000632, titled "METHOD AND SYSTEM FOR IDENTIFYING OPTIMAL IMAGE WITHIN A SERIES OF IMAGES THAT DEPICT A MOVING ORGAN" published on 27 January, 2005, the contents of all are incorporated herein by reference.

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION

The present invention relates to medical devices in general, and to a method and apparatus for positioning and presenting a device in a tubular organ, in particular.

DISCUSSION OF THE RELATED ART

Patients suffering from physiological abnormalities such as lumen stenosis or aneurysm may undergo procedures involving interventional cardiology. For example, in order to treat a stenotic coronary artery, a balloon mounted on a guide wire is inserted into the vessel and inflated at the stenosis position, thus dilating the vessel by compressing atherosclerotic plaque against the vessel wall. Sometimes a balloon is insufficient and a tubular prosthesis, i.e. a stent is also mounted on the guide wire and positioned at the stenosis area in order to hold the vessel open. Positioning a device in the appropriate location relative to the stenosis is a challenging task even for a skilled physician, even in cases of good vessel imaging conditions (e.g. the vessel is not tortuous, no occlusions, no side branches in the region of interest, easy to arrive at with a catheter). This is caused by the physician being able to see only one of the two data sources at a time: the device, through radiopaque markers attached to it in an x-ray image; or the tubular organ with its stenotic area in an angiogram involving the injection of contrast material, but not both of them simultaneously. An organ can not be seen in an x- ray image, unless contrast material is present, while the device can not be seen when contrast material is present (for example in an angiogram). The lack of possibility to view the stenosis, the vessel, and the device simultaneously, occasionally results in excess contrast material injections, since the physician iteratively advances the device to the estimated position of the stenosis, and then applies an injection in order to validate the device's position in the vessel, until reaching the optimal position. The lack of possibility can also result in suboptimal or even dangerous positioning of the device, which sometimes calls for an additional device insertion. Bi- ventricular pacer lead insertion is yet another interventional radiology procedure where accurate positioning of a device is crucial. By placing a pacer lead in different positions in the coronary vein tree and checking the heart response to discharges of electric impulses, the physician chooses the optimal position to insert the lead. In addition to the above mentioned difficulty of merging information from two sources, an additional challenge concerns the navigation of the pacer back to the exact position in which the best result was encountered. In this case an automatic navigation system that fuses the morphology of the coronary vein tree and the current position of the lead would clearly facilitate the procedure considerably. Another difficulty in such tasks results from the tubular organs being subject to movements, both arbitrary, for example caused by the subject's movements and periodical, such as motion created by blood flow, breathing or the like.

Several previously known positioning systems have been introduced for the use in positioning a device in a vessel. Some of these systems use dedicated equipment based on optical, electromagnetic, ultrasonic principles or the like, for device localization. A major drawback of these systems, when applicable, is that they employ independent sensors and transducers for measuring the relative distance of the device from an origin, which requires a complicated calibration procedure. Moreover, an added modality considerably increases the overall complexity and cost of the procedure.

International patent application serial number PCT/IL2005/000360 titled "METHOD AND APPARATUS FOR POSITIONING A DEVICE IN A TUBULAR ORGAN" filed on 31 March, 2005, proposed a computational solution to the registration, i.e. the correspondence between a device and a tubular organ. However, there is a difficulty with this approach, since the exact location of the device relatively to the tubular organ is estimated, in order to define a region of interest in which the device is present. Based on the estimate, a finer search is performed, and when the device is detected, it is positioned on an image of the tubular organ. This approach is computationally expensive, and provides inaccurate results.

Guide wires that carry markers which are visible in an x-ray have been introduced. However, such guide wires can only serve as rulers for measuring features. A major drawback is that when only a small section of the guide wire, consisting of part of the markers, is seen in an x-ray image, a physician can not tell the exact location of a specific marker in relation to the tubular organ. In particular, one can not tell if the guide wire has moved during the procedure.

In view of these limitations, it would be desirable to provide a tool and a method that would enable the registration between a tubular organ, seen in one imaging modality and the device, seen by another imaging modality. It would also be desirable to provide a method that uses the proposed tool in order to position the device on a model of the tubular organ. The method and tool should provide accurate navigational and positional capabilities by being computationally efficient and by using no additional equipment to what is commonly used in such procedures.

SUMMARY OF THE PRESENT INVENTION

It is an object of the present invention to provide a novel tool for registering an image showing a device with an image showing a tubular organ, which overcomes the disadvantages of the prior art. In accordance with the present invention, there is thus provided a tool passing through a tubular organ comprising one or more characteristics seen in one or more images taken by an imaging modality, for registration between a tubular organ and a device delivered to the tubular organ. The characteristics of the tool can radiopacity. The tool can comprise one or more radiopaque sections, or the tool can be uniformly radiopaque. In yet another alternative, the characteristic can be one or more marker groups comprising one or more markers, the at least one marker viewable by the imaging modality. Each marker group is uniquely distinguished in an image taken by the imaging modality, from an at least one other marker group. Alternatively, one or more marker groups can repeat at a different location along the tool. Within the tool, the imaging modality can be x-ray, CT, ultrasound, or MRI. The tool can be a catheter; a balloon; an electrode; a prosthesis; a guide wire; a stent; a device delivered to the tubular organ; or a device delivered through the tubular organ. The device can be a catheter; a guide wire; a device delivered to the tubular organ; or a device delivered through the tubular organ. The tubular organ can be the aorta, an artery, a vein, a capillary, a blood vessel, or a tube-like body organ.

Another aspect of the disclosed invention relates to a method for presenting a device within a tubular organ of a subject on a reference image comprising the tubular organ, the device comprising an at least one marker viewable by an imaging modality, the method comprising the steps of: receiving a reference model comprising the tubular organ; generating an at least one first reference image of the tubular organ; inserting a tool comprising an at least one characteristic viewable by an imaging modality into the tubular organ; selecting an at least one first image showing the tubular organ; generating a first registration between the at least one first reference image with the at least one first image showing the tubular organ; selecting an at least one second image showing the at least one characteristic of the tool, taken by the imaging . modality; generating a second registration between the first image and the second image; generating a second reference image showing the tool and the tubular organ; if the device is separate from the tool, delivering the device to the tubular organ; receiving one or more third reference images, taken by the imaging modality showing the characteristic of the tool and one or more markers of the device; registering the first reference image with the second reference image; registering the third reference image with the second reference image; creating a combined image by registering the third reference image with the first reference image and presenting a combined image of the device on the first reference image. The method can further comprise a step of selecting a position for the device within the tubular organ, based on the combined image. The device can be a catheter; a balloon; an electrode; a prosthesis; a guide wire; a stent; or a device delivered by means of the tool. The tool can be a catheter; a balloon; an electrode; a prosthesis; a guide wire; or a stent. The imaging modality can be x-ray, CT, ultrasound, or MRI. The tool can be coded guide wire. Within the method, the step of generating the first reference image can comprises selecting a first image, the first image used during construction of the reference model. The tubular organ can be the aorta, an artery, a vein, a capillary, a blood vessel, or a tube-like body organ. BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be understood and appreciated more folly from the following detailed description taken in conjunction with the drawings in which:

Fig. 1 is a schematic illustration of a front view of a coded guide wire, in accordance with a preferred embodiment of the disclosed invention;

Fig. 2 is a schematic illustration of a front view of a coded guide wire, in accordance with another preferred embodiment of the disclosed invention; and Fig.3 is a flowchart showing the main steps in a method that uses a coded guide wire for positioning a device in a tubular organ, in accordance with a preferred embodiment of the disclosed invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The present invention overcomes the disadvantages of the prior art by providing a tool passing through a tubular organ, for registration between the tubular organ and a device delivered to the tubular organ. The tool can be any tool inserted into a tubular organ, known today or that will become known in the future, with an addition or enhancement to the tool or a part thereof, of characteristics viewed on an image taken by an imaging modality, such as one or more radiopaque markers or change on opacity level, such that the marker or the tool itself or a part thereof are shown in an image taken by an imaging modality. The tool can be a catheter, a balloon, a stent, a guide wire or any other tool inserted into a tubular organ. The present invention further discloses a method using the proposed tool for presenting the device on an image of the tubular organ. The device could be the tool itself. Alternatively, the tool can be an auxiliary tool, used for registering a device, which is independent from the tool. The proposed invention discloses a tool comprising characteristics of radiopacity, for example a tool which is a fully or alternately radiopaque guide wire, i.e. a guide wire which is fully radiopaque, or a guide wire that comprises one or more radiopaque sections. Since the tool passes through the tubular organ, the tool shows the outline of the tubular organ in an image which does not show the tubular organ. Having a tool which shows the general outline of the tubular organ in an imaging modality, enables the disclosed method, for registering an image showing the tool and a second image showing the tubular organ.

In a preferred embodiment the proposed tool is a coded guide wire. A coded guide wire is a guide wire used for delivering a device to a desired location within a tubular organ, wherein the wire comprises uniquely distinguishable radiopaque markers along its span, which uniquely identify an exact position along the wire. The markers can be spanned along the guide wire in a coded manner, as is detailed in association with Fig. 1 and Fig. 2 below. In an alternative embodiment, the guide wire is fully radiopaque. In yet another embodiment, guide wires comprising non distinguishable radiopaque markers or sections can be used. In the last two embodiments, the guide wire enables the registration between the tubular organ and the tool, due to the common outline of the guide wire and the tubular organ. The device to be delivered can be a catheter, a guide wire, a pacer, aprosthesis, an electrode, a stent, a pacer lead, a balloon or any other device currently known or that will become known in the future to be delivered to a tubular organ.

When the tool is used to deliver a device to the tubular organ, the tool and the device, for example a stent, also carrying radiopaque markers, are registered with an image of a reference source showing a body area of the subject containing the tubular organ. The distinguishable markers, or the shape of the wire, enable the exact detection and positioning of the device while delivered along the wire. The exact positioning of the device in the required location is performed by: first registering an image of the tool with an image of the relevant area of the tubular organ as taken by an angiogram after a contrast material injection, and then by using x-ray images following the device delivered using the tool until the device reaches the desired position relatively to the relevant markers.

The present invention can be implemented, but is not restricted to a catheterization procedure and bi-ventricular pacing. When the tubular organ under discussion is an artery, the device is usually an intravascular therapeutic device, such as a stent, a balloon, a pacing lead, or the like. However, in a catheterization procedure, the device and the tool coincide.

The present invention can also be implemented, but is not restricted, to other procedures such as intra-vascular ultra-sound, where there is a need for navigation and localization of the ultra-sound transducer. It could also be implemented to other procedures such as valve replacements, in which localization of the valve position in crucial, etc. The present invention can also be implemented to navigation and localization of other devices with radiopaque characteristics, such as catheters or could employ such devices as part of the method. Referring to Fig. 1 and Fig. 2, showing two preferred embodiments of coded guide wires generally referenced 10 and 50, respectively. Part 12 of guide wire 10 and part 52 of guide wire 50 represent, respectively, the distal part of guide wires 10 and 50. Parts 14 and 54 represent, respectively the tips of guide wires 10 and 50. Marker combination 16, 20, 24 and 28 on guide wire 10, and marker combination 56, 60, 64 and 68 on guide wire 50 illustrate a possible arrangement of the markers which are uniquely distinguishable. Markers 16, 20, 24 and 28 consist of marker pairs of different widths in various combinations, whereas markers 56, 60, 64 and 68 consist of collections of markers consisting of different number of markers. The coded guide wires depicted in Fig. 1 and in Fig.2 are representative coded guide wires but the coding is not restricted to these specific arrangements. The markers and marker combinations can vary in length, material, number, shape, number of markers in a group, opacity level under x-ray, or other parameters as long as they can be uniquely distinguished. The spaces between markers belonging to the same group, such as within marker groups 16, 20, 56, 60 or others, can be of equal length or variable lengths. Similarly, the distances between marker groups, such as distances 32, 36, 40, 72, 76, or 80 can be equal or vary. The coded guide wire comprises a guide wire and markers. The guide wire can have similar characteristic to currently used guide wires or guide wires that will be used in the future, such as a diameter of between 0.008 inches and 0.03 inches, and typically about 0.014 inches. The guide wire is preferably tapered toward its flexible tip. The markers can be substantially circular, and substantially encircle the perimeter of the guide wire. In an alternative embodiment, the markers can be attached to a predetermined part of the wire, as long as they can be seen under the imaging modality. The markers can be attached to an internal or an external part of the wire. In yet another alternative, part of the wire itself can be made of a material having different radiopacity characteristics than the rest of the wire. The markers are preferably made of a material that is shown under the same modality that shows the markers on the used device. For example, if the used modality is x-ray, the markers should be made of radiopaque materials, that preferably include platinum, rhodium, palladium, and rhenium, such as tungsten, gold, silver, tantalum or any alloys of these metals. The width of each marker is typically, but not constrained to 1-2 mm and the overall length of each group of markers is typically but not constrained to 10-20 mm. It is also possible to use a coded guide wire comprising a set of marker groups, which repeats twice or more along the guide wire. For example, a predetermined collection of distinguishable marker groups can stretch along 50 cm or another length. Since positioning a device is measured in much smaller distances, repetition of the pattern after 50 cm is not likely to confuse a physician, and the ability to distinguish a certain marker is preserved. While preferred embodiments of the coded guide wire are described above, it would be apparent to a person having ordinary skill in the art that various changes and modifications may be made therein without departing from the spirit of the invention. The appended claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention. Referring now to Fig. 3, showing a preferred embodiment of a method for positioning a device within a tubular organ. For example, the method can be used for positioning a stent mounted on a coded guide wire, on a reference model of a vessel. The method is described in detail in International patent application serial number PCT/IL2005/000360 titled "METHOD AND APPARATUS FOR POSITIONING A DEVICE IN A TUBULAR ORGAN" filed on 31 March, 2005. However, the steps dealing with registration of an image showing the device with an image showing the tubular organ, are implemented by the disclosed invention in an enhanced manner. The method described below comprises steps for selecting an image from a series of images, according to criteria such as the phase of a periodical motion in which an image was taken. The method is based on periodicity analysis of one or more features seen in a series of images. The method is detailed in International patent application serial number PCT/IL2004/000632, titled "METHOD AND SYSTEM FOR IDENTIFYING OPTIMAL IMAGE WITHIN A SERIES OF IMAGES THAT DEPICT A MOVING ORGAN" published on 27 January, 2005. In the method detailed in PCT/IL2004/000632 the moving organ is used as a feature for determining periodicity. However, other features, including elements detectable in one or more images, such as a therapeutic device, a guide wire or a tip thereof, a part of an organ or the like can be used. Preferably, the method of the present invention comprises a diagnostic stage 300 and a therapeutic stage 320. During diagnostic stage 300, a three dimensional model of the tubular organ is constructed at step 304 from two angiograms of the tubular organ taken from two different views. The two angiograms are preferably selected from two sequences of angiograms (hereinafter: the R sequences), such that the angiograms depict the tubular organ at the same phase of the periodical movement, caused for example by the heart beat or by breathing. The model construction is detailed in International patent application serial number PCT/IL01/00201 titled "SYSTEM AND METHOD FOR THREE-DIMENSIONAL RECONSTRUCTION OF AN ARTERY" published on 15 November, 2001. Once the model is constructed, at step 308 one of the two angiograms used for constructing the model is selected as a reference image (hereinafter: the R-image). Alternatively, a third image, which can be a synthetic image such as a projection of the model on a predetermined plane is generated as the R-image. All possible R-images share the same phase according to the phase of the selected angiograms, which was determined by periodicity analysis of one of the R sequences. The therapeutic stage can be performed minutes, hours, or days after the diagnostic stage, and typically follows the diagnostic stage in 1-60 minutes). In another preferred embodiment, the method avoids diagnostic stage 300 and employs therapeutic stage 320 only, during which the system receives a model that was generated or otherwise acquired earlier. During a typical therapeutic stage, a guide wire is navigated along the tubular organ. Then a therapeutic device is mounted on the guide wire and is delivered through the guide wire to the tubular organ. The device is detected by following the movement of radiopaque markers located thereon, in a sequence of x-ray images. Positioning the device appropriately is a complex task since the tubular organ is only seen in angiograms, in the presence of contrast material, whereas the device is only seen in x-ray images, in the absence of contrast material. In order to overcome this problem, the operator alternatively injects contrast material and advances the device in short steps. This manipulation is unfavorable, since it implies both excessive injections of contrast material, and trial-and-error on the side of the physician. Therefore, there is a need to synthesize a common image, displaying both type of information. However, synthesizing such an image is also a complex task because images are static while the tubular organ is constantly moving due at least to heart beats and breathing. Using the coded guide wire of the disclosed invention facilitates the positioning task. During therapeutic stage 320, at step 324 a coded guide wire as shown in Fig. 1, Fig. 2, or as described in association with Fig. 1 or Fig. 2 above, is inserted into the tubular organ and is advanced through it. The coded guide wire is advanced until it is stopped, or otherwise reaches an unmoving position. Then at step 328 the system acquires a sequence of x-ray images depicting the coded guide wire within the tubular organ (hereinafter: the CGW-sequence). The sequence preferably lasts approximately two heart beat cycles, and is followed by a sequence of angiograms taken after a contrast material injection, depicting the tubular organ (hereinafter: the WI- sequence). The WI-sequence preferably lasts approximately two heart beat cycles, too. At step 332 periodicity analysis is performed on the WI-sequence (angiograms) using the tubular organ as a feature, the resulting periodicity is synchronized with the periodicity resulting from the periodicity analysis of sequence R as performed during model construction step 304, and a frame corresponding in phase to the R-image is selected from the WI sequence (hereinafter the WI-image). Similarly, periodicity analysis is performed on the CGW sequence based on the markers of the guide wire as features, and a corresponding image is selected (hereinafter: the CGW-image). The radiopaque markers are identified in the selected image. At step 336 WI-image and CGW- image are registered, resulting in a synthetic image (hereinafter: the CGW&WI- image), that consists of both the coded guide wire and the tubular organ. Since WI-image and R-image are synchronized, registration between the R-image and the WI-image is performed, and the registration between the WI-image and the CGW&WI-image is already established, the combination of which provides the registration between the R-image and the CGW&WI-image. At this point, the proposed method achieved a registration between the model of the tubular organ and the proposed coded guide wire. This registration is achieved since the proposed coded guide wire is seen in CGW image, in contrast to the prior art, where the commonly used guide wire is not seen in x-ray. At step 340, the therapeutic device, such as a stent, a pace maker or another is mounted on and delivered through the coded guide whilst seen on an x-ray image. Then the device positioning is initiated. At step 344 the device and the coded guide wire are detected and tracked in one or more sequences of x-ray images (hereinafter: the DVC&CGW sequence). Each image in the x-ray sequence (hereinafter the DVC&CGW-image), undergoes detection of both markers that are attached to the device, and markers attached to the coded guide wire. Then, the device's location relatively to the coded guide wire is determined. Since the markers of the coded guide wire are uniquely distinguishable, the mapping from each DVC&CGW image to the CGW&WI-image is established, and the device's position relatively to the coded guide wire in the CGW&WI image is determined. The mapping between the device and the tubular organ, was previously demonstrated in International patent application serial number PCT/IL2005/000360 titled "METHOD AND APPARATUS FOR POSITIONING A DEVICE IN A TUBULAR ORGAN" filed on 31 March, 2005. The difference between the prior art and the proposed mapping technique is evident when the device moves. When the device is moving along the coded guide wire its position is seen and tracked relative to the coded guide wire. At this point the mapping between the coded guide wire and the R-image was established at step 336, while the prior art should compute this mapping for each frame independently. Then, at step 348, since the mapping from CGW&WI image to R-image is already established, the device's position in the R-image is determined, too, and the device is displayed on the reference source. At this point, the physician can determine the position of the device and verify that the device is placed at an appropriate location.

When the device is the tool, for example in catheterization procedures, the exact location of the tool, relatively to a previous location can be determined, since the correspondence between the tubular organ and hence of the catheter is available based on the previously performed periodicity analysis. When the guide wire is uniformly radiopaque, or comprises non-distinguishable markers, the mapping between the CGW- image and the WI-image is performed based on comparing and matching the shape of the guide wire with the shape of the tubular organ.

The proposed invention discloses a method for positioning a device in a tubular organ. The proposed invention further discloses a tool in order to register an image showing the proposed tool with an image showing the tubular organ. The proposed tool is preferably seen under the same imaging modality that shows the device. The invention comprises an optional stage in which a model of the tubular organ is constructed, or alternatively, such a model can be received from an external source. In a subsequent stage, a device that is delivered by means of the proposed tool, is detected, tracked, positioned and presented in the model provided by the previous stage. The disclosed method uses the disclosed tool in order to supply a well needed registration between an image showing the device and an image showing the tubular organ. Since further registration between the image showing the tubular organ and a reference model of the tubular organ is also available, it is thus possible to show the location of the device on the reference image. The device and method do not require additional equipment in excess of what is commonly used in the relevant types of procedures, and moreover minimizes the application of harmful contrast material and radiation dose to the patient.

The description above suggests a possible implementation of the proposed method. It is clear that other divisions of the process into steps which perform parts of the methods in different order, or perform them with changes not departing from the spirit of the current invention can be employed as well. It will also be appreciated that the tool and method can be applied to any tubular organ and to any device, since no reliance is made on specific features associated with a certain tubular organ or a certain device. The disclosed tool is not limited to being used under x-ray imaging modality. Rather, using the same materials to represent the device and to represent the tool will supply the same effect as both will be shown on the same image and will be used as the DVC&CGW image. In yet another alternative, the tool and the device can be seen under different modalities and matched. A person skilled in the art will appreciate that the described method could employ, in whole or in part, a tool with different radiopaque characteristics. For example, the discussed guide wire could be partially opaque, as some of the guide wires are today, fully opaque (from proximal end to distal tip), could present identical markers or, in the preferred embodiment, present coded markers. The method described above will apply, in while or in part, for any of those tools. A tool with coded markers will probably provide the best combination in terms of speed and accuracy. In yet another alternative, the markers or the characteristics of the tool can be made of a material seen under an imaging modality such as a CT, MRI, ultrasound, or another modality, currently known or that will become known in the future, wherein the same type of modality is used during the procedure. It will also be appreciated that the disclosed tool can be any tool currently inserted into tubular organ, with an addition or enhancement of characteristics viewed on an image taken by an imaging modality, for example a radiopaque marker, or radiopacity of the tool itself. The tool can be used in any tubular organ, such as the aorta, an artery, a vein, a capillary, a blood vessel, or any other tube-like body organ.

■ It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined only by the claims which follow.

Claims

CLAIMS What is claimed is:

1. A tool passing through a tubular organ comprising an at least one characteristic seen in an at least one image taken by an imaging modality, for registration between a tubular organ and a device delivered to the tubular organ.

2. The tool of claim 1 wherein the at least one characteristic is radiopacity.

3. The tool of claim 1 wherein the tool comprises an at least one radiopaque section.

4. The tool of claim 1 wherein the tool is uniformly radiopaque.

5. The tool of claim 1 wherein the characteristic viewable by the imaging modality is an at least one marker group comprising an at least one marker, the at least one marker viewable by the imaging modality.

6. The tool o claim 5 wherein each of the at least one marker group is uniquely distinguished in an image taken by the imaging modality, from an at least one other marker group.

7. The tool of claim 5 wherein the at least one marker group repeats at a different location along the tool.

8. The tool of claim 1 wherein the imaging modality is taken from the group consisting of: x-ray, CT, ultrasound, or MRI.

9. The tool of claim 1 wherein the tool is any of the group consisting of: a catheter; a balloon; an electrode; a prosthesis; a guide wire; a stent; a device delivered to the tubular organ; or a device delivered through the tubular organ.

10. The tool of claim 1 wherein the device is any of the group consisting of: a catheter; a guide wire; a device delivered to the tubular organ; or a device delivered through the tubular organ.

11. The tool of claim 1 wherein the tubular organ is the aorta, or an artery, or a vein, or a capillary, or any blood vessel, or any tube like body organ.

12. A method for presenting a device within a tubular organ of a subject on a reference image comprising the tubular organ, the device comprising an at least one marker viewable by an imaging modality, the method comprising the steps of: receiving a reference model comprising the tubular organ; generating an at least one first reference image of the tubular organ; inserting a tool comprising an at least one characteristic viewable by an imaging modality into the tubular organ; selecting an at least one first image showing the tubular organ; generating a first registration between the at least one first reference image with the at least one first image showing the tubular organ; selecting an at least one second image showing the characteristic of the tool, taken by the imaging modality; generating an at least one second registration between the at least one first image and the at least one second image; generating an at least one second reference image showing the tool and the tubular organ; if the device is separate from the tool, delivering the device to the tubular organ, otherwise advancing the device inside the tubular organ; receiving an at least one third reference image, taken by the imaging modality showing the at least one characteristic of the tool and at least one marker of the device; registering the first reference image with the second reference image; registering the third reference image with the second reference image; creating a combined image by performing the steps of: registering the third reference image with the first reference image; and presenting a combined image of the at least one device on the at least one first reference image.

13. The method of claim 12 further comprising the step of selecting a position for the device within the tubular organ, based on the combined image.

14. The method of claim 12 wherein the device is a catheter; a balloon; an electrode; a prosthesis; a guide wire; a stent;, or a device delivered by means of the tool.

15. The method of claim 12 wherein the tool is catheter; a balloon; an electrode; a prosthesis; a guide wire; or a stent,

16. The method of claim 12 wherein the imaging modality is taken from the group consisting of: x-ray, CT, ultrasound, or MRI.

17. The method of claim 12 wherein the tool is a coded guide wire.

18. The method of claim 12 wherein the step of generating the at least one first reference image comprises selecting an at least one first image, the at least one first image used during construction of the reference model.

19. The method of claim 12 wherein the tubular organ is the aorta, or an artery, or a vein, or a capillary, or any blood vessel, or any tube like body organ.