ENERGY DIRECTION MARKERS
BACKGROUND OF THE INVENTION
There are various medical procedures where energy is directed toward subject tissue under fluoroscopic guidance. One example is an ablation procedure for cardiac arrhythmias. In that procedure, an energy emitting device is drawn through a vessel under fluoroscopic guidance. Preferably photonic diffusing tip catheters with gold reflectors on one side are used to preferentially direct energy to subject tissue. An example of such a device can be seen in U.S. Patent 5,908,415 at Fig. 5. In that figure, reflector 62 causes energy to be directed in a certain direction, h order to determine in which direction the energy is directed, the operator must first observe the device under fluoroscopy, then rotate the device and lastly, view it under fluoroscopy a second time. The direction of energy emission is then determined from how the fluoroscopic view of the device changed from the first observation to the second. The operator observes how the gold reflector has moved from the first view to the second, thus revealing the direction of energy emission.
These extra steps that must be taken prior to treating the subject tissue delay the treatment, lengthen the overall procedure, and are somewhat subjective relying on operator judgment. Thus there is a need for energy emitting devices to possess methods to indicate the direction of the energy.
SUMMARY OF THE INVENTION
The present invention addresses the foregoing need of the prior art. In particular, the present invention provides energy direction markers which quickly and accurately indicate the direction in which energy will be emitted when initially viewed under fluoroscopy while minimizing the need for operator judgment. The invention catheter system includes: an elongated rotatable tube being rotatable about a longitudinal axis and having a distal end and a proximal end; an energy emitter located at the distal end of the elongated rotatable tube;
and at least one energy direction marker at the distal end of the elongated rotatable tube, which is visible under fluoroscopy and indicates the direction of energy emission from the energy emitter, such that the direction of energy emission can be varied and is indicated as a function of rotation of the elongated rotatable tube about a longitudinal axis.
The energy direction marker may be a band that is fully circumferential around the distal end of the elongated tube and is located adjacent to an energy emitter.
The energy direction marker may be made from gold, platinum, tantalum or radiopaque ink. The catheter system may emit ultrasound energy, cryothermal energy, radiofrequency energy or microwave energy.
The energy emitter can be a light diffuser and may include an energy reflecting element.
The energy direction marker may be integrated into the energy reflecting element and may be a protrusion from the energy reflecting element or a void in the energy reflecting element which is the result of a cut-away. The protrusion or void is of a shape or geometry which when viewed under fluoroscopy indicates orientation of the energy emitter and hence direction of energy emission.
Alternatively, the energy direction marker may be separate from the energy reflecting element.
The energy reflecting element may be made from gold.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing and other objects, features and advantages of the invention will be apparent from the following more particular description of preferred embodiments of the invention, as illustrated in the accompanying drawings in which like reference characters refer to the same parts throughout the different views. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention.
Fig. 1 is a schematic diagram of a catheter system of the present invention as used in a vein, an artery or any other anatomical duct.
Fig. 2A is a diffuser tip with an energy reflector and a solid circumferential band serving as an energy direction marker of the present invention. Fig. 2B is a cross-sectional view of the diffuser tip of Fig. 2A when viewed under fluoroscopy.
Fig. 3 is a diffuser tip with triangular energy direction markers that are integrated into the energy reflector.
Fig. 3 A is a view of the diffusing material when laid flat and having energy direction markers on both longitudinal sides.
Fig. 4 is a diffuser tip with semi-circular energy direction markers created by cutaways in the energy reflector.
Fig. 5 is a diffuser tip with triangular energy direction markers created by cutaways in the energy reflector. Fig. 6 is diffuser tip with triangular energy direction markers created by protrusions from the energy reflector.
Fig. 7 and 7 A are schematic views of the light diffusing tip employed in the preferred embodiment.
DETAILED DESCRIPTION OF THE INVENTION A description of preferred embodiments of the invention follows.
In each of these examples, a fluoroscopic view that is in a plane perpendicular to the desired energy direction presents the best view of the Energy Direction Markers. Under fluoroscopy, the only material that can be seen is the radiopaque material, usually gold, out of which the energy reflector or solid circumferential band serving as an energy direction marker is made.
Illustrated in Figure 1 is a catheter system embodying the present invention. The catheter system 1 is formed of an elongated body 2 rotatable about a longitudinal axis, an energy reflector 4 at the distal end 3 of the elongated rotatable tube 2 and at least one energy direction marker 5 at the distal end 3 of the elongated rotatable tube 2. In the
preferred embodiment, the energy reflecting element (energy reflector) 4 is a diffusing tip 60 such as that described in U.S. Patent No. 5,908,415 and illustrated herein in Figures 7 and 7 A. The illustrated light diffusing tip 60 utilizes a reflector 62 placed on one side of the diffusing tip (about 180 degrees radially or extending around about half the circumference, throughout the length of the energy emitter 63, or other circumferential reflector angles may be used). The reflector 62 is preferably formed of gold foil or other material of high reflectance and relatively low hardness such that it is easily formed into shape. The reflector 62 blocks and reflects light back towards the scattering media (energy emitter) 63 of the light diffusing tip 60. As such, the energy emitting element 63 with such a reflector 62 causes more energy to be directed toward the tissue of interest. The direction of energy emission is indicated by arrows radially throughout about 180° in Fig. 7A.
Figure 2A shows a diffusing tip 3 that uses a solid circumferential band 5 to indicate the direction of energy. This solid circumferential band 5 has a diameter very similar to that of the entire diffusing tip 3. The energy reflector 4 is of semi-cylindrical shape like reflector 62 of Fig. 7 and 7 A and is located adjacent to the solid circumferential band 5. Figure 2B is a profile view of the diffusing tip of Figure 2 A when viewed under fluoroscopy. The circumferential band appears as a line the length of its diameter. The energy reflector 4 appears as a long rectangle in the axial direction and indicates the length of the diffusing tip, its width depending on the current rotation of the diffusing tip 3 and varying from half of the diameter of the solid circumferential band 5 when the energy direction is either straight up or down, to nearly the full diameter of the solid circumferential band 5 when the energy direction is either straight into or out of the page. If the energy reflector 4 appears to be aligned with the lower portion of the solid circumferential band 5, then the direction of energy emission is upward. Likewise, if the energy reflector 4 appears to be aligned with the upper portion of the solid circumferential band 5, then the direction of energy emission is downward. Thus, as the catheter 1 and hence the diffusing tip 3 is rotated, the operator can instantly know in which direction the energy will be emitted.
The energy direction markers can also be integrated into the energy reflector itself, obviating the need for a separate object such as the solid circumferential band 5 of Fig. 2A and 2B. Figure 3 shows one such embodiment where the energy reflector 25 is extended longitudinally from both ends of the reflector 25 beyond the area 21 in which energy is emitted. The extended portions 22 of the energy reflector 25 are shaped to indicate the direction in which energy is emitted. The shape demonstrated in Figure 3 consists of (i) a triangular cutout 23 pointing down from the edge of the elongated portion of the reflector in series with (ii) half of another triangular cutout 24 pointing down, thus leaving a triangular shaped portion of the elongated portion of the energy reflector 26 pointing up (away from the reflector edge) and indicating the direction of energy emission. Thus, when viewed under fluoroscopy, the shape of these extended portions of the reflector ends 22 serve as energy direction markers which instantly reveal the direction of energy emission. The energy reflector 25 can be extended on one longitudinal side only so that it's fluoroscopic image will not be blocked by any part of the reflector 25 on the other side, or it can be extended on both longitudinal sides, in which case the energy direction markers will be visible when the diffusing tip 60 is rotated such that the energy direction markers are in alignment when viewed from the side. Figure 3 A shows the shape of the diffusing material when laid flat and where there are energy direction markers on both longitudinal sides. Figures 4 and 5 show other variations of energy direction markers that consists of portions of the energy reflector 31 and 41 that are cut away and show as voids 32 and 42 in the energy reflector's profile when viewed under fluoroscopy. These voids 32 and 42 are made by cutting away a portion of the energy reflector 31 and 41 from the area that would appear as the bottom of the reflector when viewed in an orientation where energy emission is upward. In Figure 4, the shape cut away is that of a semi-circle and in Figure 5 the shape cut away is a triangle. The arch or point, respectively, of these cut-away shapes thus provides a visual indication under fluoroscopy of the direction in which the reflector is oriented and hence the direction in which energy is emitted.
Figure 6 shows an alternative to cut-aways in the energy reflector. In particular, Fig. 6 shows pointed protrusions 52 from the edge of the energy reflector 51 that serve as
direction indicators. Triangular shapes are shown in Figure 6, but many shapes will sufficiently indicate energy direction.
While this invention has been particularly shown and described with references to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the invention encompassed by the appended claims.
For example, the energy direction markers of Figures 3 through 6 need not be integrated with the energy reflector. The energy direction markers can be separate elements from the energy reflector. The energy direction markers can be located elsewhere in the elongated rotatable tube provided they are still visible under fluoroscopy at the same time as the energy reflector. The energy direction markers need not protrude or be cut away from the upper or lower profile edge of the energy reflector, but may also extend or be cut away from the sides of the energy reflector. The energy direction marker need not be any specific geometric shape that "points" to the direction of energy emission, rather it can be an entirely separate piece of radiopaque material that is in such proximity to the energy reflecting element such that when viewed under fluoroscopy, the relationship of the piece of radiopaque material to the energy reflecting element renders the direction of energy emission obvious upon initial view.