Chronic total occlusions (CTO) can be found in coronary angiography, occurring in approximately 18-33% of patients with documented coronary artery disease. Percutaneous revascularization (angioplasty) is attempted in less than 10% of CTOs. Approximately 25% of cases undergo bypass surgery, while the majority (approximately 65%) are treated medically. The main reasons for not attempting percutaneous revascularization include the frequent presence of multi-vessel disease, and the complexity and time requirements of performing these technically challenging percutaneous procedures.
About 70% of percutaneous revascularization procedures are successful. This is primarily due to the difficulty in crossing the occlusion with guidewires in the antegrade direction. A challenge is crossing the fibrotic and often calcified material that is occluding the artery and then re-entering the true lumen beyond the occluded segment. In some cases, the guidewire immediately re-enters the true lumen at the end of the CTO (just past the distal end), which is known as true-true crossing. However, in many cases, the guidewire cannot cross the occlusion, but is in a subintimal position after the occlusion and has to re-enter the true lumen further downstream—so called true to false to true. In some cases, downstream re-entry can be done by reshaping the tip of CTO specialty guidewires advanced through a central lumen microcatheter (such as finecross or corsair) and directing the guidewire back into the true lumen. Also, angulated microcatheters can be used, but control of the angle of the tip can be challenging in the subintimal space.
More recently, a specialized CTO device has been introduced that first involves advancing a catheter (known as the CrossBoss), which is a proximal torque device that utilizes bidirectional rotation with a fast-spin technique, in order to advance across the occlusion as the spin reduces the push required. Although this catheter can be advanced within the luminal space, it is usually advanced within the subintimal space and then the CrossBoss catheter is replaced with a special flat balloon that has two holes at different orientations (Stingray balloon) through which the operator advances a very stiff guidewire (Stingray wire) to re-enter the artery. This is a technically challenging procedure that requires extensive training and has been restricted so far to highly expert operators.
Subintimal positioning of the guidewire (i.e. inside the wall of the coronary artery rather than the true lumen) after crossing the occlusion is a major problem and common failure more in CTO PCI, and highlights the need for additional options to facilitate re-entry into the true lumen of the artery after the occlusion.
The present disclosure addresses the aforementioned challenges by providing a catheter device designed for lumen re-entry, which may be used for percutaneous CTO revascularization and other applications, such as angioplasty procedures where it can be challenging to position a guidewire in a side branch vessel with a difficult angulation.
It is an aspect of the present disclosure to provide a catheter that includes a catheter shaft having a tubular wall that extends from a proximal end to a distal end along a longitudinal axis to define a lumen. The tubular wall having formed therein an inner lumen that extends from the proximal end to the distal end of the catheter shaft. The catheter device also includes a deflection member coupled to the distal end of the catheter shaft and in fluid communication with the inner lumen such that fluid provided to the inner lumen causes the deflection member to expand from a first volume to a second volume that is larger than the first volume. When the deflection member is in the second volume, it extends from a surface of the tubular wall towards the longitudinal axis of the catheter shaft to provide a surface for deflecting an interventional device extending through the lumen and outward from the distal end of the catheter shaft at a deflection angle.
The foregoing and other aspects and advantages of the invention will appear from the following description. In the description, reference is made to the accompanying drawings which form a part hereof, and in which there is shown by way of illustration a preferred embodiment of the invention. Such embodiment does not necessarily represent the full scope of the invention, however, and reference is made therefore to the claims and herein for interpreting the scope of the invention.
By way of overview and introduction, a catheter device that can provide subintimal orientation and re-entry into a lumen is generally illustrated in
Referring now to
The wall of the catheter shaft 12 has formed therein an inner lumen 26 extending from the proximal end 14 to the distal end 16 of the catheter 10. The inner lumen 26 receives a hypotube 28 that is in fluid communication with the deflection member 22. The deflection member 22 generally spans an aperture 30 formed as the distal end of the inner lumen 26, or any hypotube 28 provided to the inner lumen 26. The aperture 30 can be formed in the distal end of the inner lumen 26, as shown in
In some other embodiments, more than one deflection member 22 can be provided at the distal end 16 of the catheter 10. In these configurations, a similar number of inner lumens 26 are formed in the wall of the catheter shaft 12 such that a different hypotube 28 may be provided to each inner lumen 26 to be in fluid communication with one of the deflection members 22.
In some embodiments, the wall of the catheter shaft 12 does not include an inner lumen 26; rather, the hypotube 28 is provided to the interior surface of the lumen 20 of the catheter shaft 12. In such configurations, it will be appreciated that more than one hypotube 28 can be similarly provided to the interior surface of the lumen 20 of the catheter shaft 12. It will also be appreciated that in some embodiments a hypotube 28 can be provided to both an inner lumen 26 formed in the wall of the catheter shaft 12, and to the interior surface of the lumen 20 of the catheter shaft 12 itself.
The wall of the catheter shaft 12 can be chamfered or beveled such that the wall slopes proximally toward the distal opening 24 of the catheter 10, thereby defining an angled surface 32. The angled surface 32, in turn, defines a maximum deflection angle at which a guidewire, or other interventional device, can be deflected upon exiting the opening 24 at the distal end 16 of the catheter 10. In some configurations, the exterior surface of the catheter shaft 12 may be inwardly tapered distal to a taper line 36 towards the distal end 16 of the catheter 10.
As mentioned above, and as shown in
The deflection member 22 is generally constructed as an expandable membrane that spans the aperture 30 in the catheter shaft 12 formed by the inner lumen 26. In some other configurations, the deflection member 22 can be constructed as an expandable membrane that spans the opening of the hypotube 28. That is, the deflection member 22 can be coupled to the catheter shaft 12 or to the hypotube 28. As described above, fluid is provided to the deflection member 22 via the hypotube 28 to expand the deflection member from a first volume to a second volume. The deflection member 22 can have a partially spherical shape; although, other shapes can also be implemented, such as partially ellipsoidal shapes and the like. The deflection member 22 can extend outwardly from the distal end 16 of the catheter 10 along a direction perpendicular, or nearly perpendicular, to the angled surface 32 of the catheter shaft 12.
In some embodiments, the deflection member 22 can be constructed as an extruded sleeve that spans the aperture 30 in the catheter shaft 12 formed by the inner lumen 26. Alternatively, the extruded sleeve can span a first aperture that is formed in the hypotube 28, which is aligned with a suitable second aperture in the catheter shaft 12, such as aperture 30. An example of this configuration in an undeployed state is shown in
In some other embodiments, the deflection member 22 can be constructed as a patch 52 made by an extruded sleeve that spans the aperture 30 in the catheter shaft 12 formed by the inner lumen 26. Alternatively, the patch 52 can span a first aperture that is formed in the hypotube 28, which is aligned with a suitable second aperture in the catheter shaft 12, such as aperture 30. The patch 52 can also be formed by dipping the catheter shaft 12 or hypotube 28 in an expandable material that spans the aperture 30 in the catheter shaft, or an aperture formed in the hypotube 28. An example of this configuration is shown in an undeployed state in
As described above, when a fluid is provided to the deflection member 22 via the hypotube 28, the deflection member 22 expands from the first volume to a second volume. When the deflection member 22 has the second volume it partially extends into the opening 24 at the distal end 16 of the catheter 10, thereby providing a surface that will deflect a guidewire, or other interventional device, passing through the opening 24 at the distal end 16 of the catheter 10. As one non-limiting example, when the deflection member 22 has the first volume, the deflection member 22 has a substantially flat shape. That is, the deflection member 22 can be relatively flat against the angled surface 32 of the catheter shaft 12. In some other embodiments, the deflection member 22 can be partially protruding from, or partially recessed relative to, the angled surface 32 of the catheter shaft 12. As the pressure supplied to the deflection member 22 by the fluid is decreased, the deflection member 22 can begin to compress and transition from the expanded shape at the second volume to the flatter shape against the angled surface 32 at the first volume. It should be appreciated that the deflection member 22 can be partially expanded, thereby expanding the deflection member 22 into an intermediate position.
In some embodiments, the catheter 10 is constructed to be a microcatheter. As one example, the catheter 10 can be constructed as a microcatheter for use in coronary arteries. Thus, in some non-limiting examples, the catheter 10 can be sized at 4.5 Fr (1.5 mm) or less. As another example, the catheter 10 can be constructed to be a microcatheter for use in peripheral arteries, which can allow a larger outer diameter than in coronary microcatheter implementations.
Referring to
In some embodiments, the catheter can be composed of more than one material. As one example, the catheter shaft can have first layer composed of a first material and a second layer composed of a second material. In such embodiments, the first layer can correspond to the inner surface of the catheter shaft 12 and the second layer can correspond to the outer surface of the catheter shaft 12. The first layer can be thin, such as 0.001″, and the second layer can be molded around the first layer and any hypotubes 28 positioned in the wall of the catheter shaft 12. As one benefit, this two-layered composition can facilitate creating a varied outer diameter for the catheter shaft 12, such as creating a tapered outer surface for the catheter shaft 12, as described above. In these embodiments, the deflection member 22 can be molded into the first layer. In other embodiments, the deflection member 22 can be formed by applying a thin membrane (e.g., a thin membrane of latex plastic or other such material) across a hypotube 28.
Referring to
The catheter shaft 12 can be constructed to have an extended portion 42 of the wall of the catheter shaft 12 that extends distally beyond the opening 24. As shown, the extended portion 42 of the wall of the catheter shaft 12 extends more distal on the first side 38 of the catheter shaft. The portion of the wall of the catheter shaft 12 that does not include the extended portion 42 may be tapered to a thinner thickness than an opposing portion of the wall of the catheter shaft 12. The extended portion 42 of the catheter shaft 12 can span one-half of a circumference of the catheter shaft 12, or may span more or less than one-half of the circumference of the catheter shaft 12.
In these embodiments, the inner lumen 26 terminates in the extended portion 42 of the catheter shaft 12 without opening to the distal end 16 of the catheter shaft 12. However, an aperture 30 is formed on the inner surface of the catheter shaft 12, such that the inner lumen 26 is open to the inner surface of the catheter shaft 12 by way of the aperture 30. The deflection member 22 in this configuration can be coupled to the inner surface of the catheter shaft 12 and can be made to span the aperture 30 such that the deflection member 22 is in fluid communication with a hypotube 28 provided to the inner lumen 26. The deflection member 22 can have a generally hemi-spherical shape that provides a deflection member 22 that is “side-firing” in the sense that the deflection member 22 expands into the lumen 20 of the catheter shaft 12 towards the longitudinal axis 18 of the catheter 10 when expanding from the first volume to the second volume.
The deflection member 22 is coupled to the aperture 30, such that the aperture 30 provides fluid communication between the deflection member and the hypotube 28 positioned in the inner lumen 26 to provide a fluid to the deflection member 22. The fluid provided to the deflection member 22 can facilitate expansion of the deflection member 22 to the second volume as described above. The deflection member 22 at the second volume partially extends into the distal opening 24 of the catheter 10 to provide a surface that will deflect a guidewire or other interventional device extending through the lumen 20 of the catheter shaft 12 by a projection angle, θ. At the first volume, the deflection member 22 can have a substantially flat shape. As fluid is removed from the deflection member 22 its volume will decrease again from the second volume to the first volume. It should be appreciated that the deflection member 22 can be partially expanded, thereby expanding the deflection member 22 to an intermediate volume.
One example of the embodiment of the catheter 10 as described above can be sized at 4.5 Fr (1.5 mm). In such embodiments, the catheter 10 can be a referred to as a microcatheter. In some implementations, the catheter 10 may be sized for use in coronary arteries, and in some other implementations the catheter 10 may be sized for use in peripheral arteries.
In another embodiment, the catheter shaft 12 can be constructed to be angled at its distal end 16, as shown in
In another embodiment of the catheter 10, a positioning member 44 can be coupled to the catheter shaft 12 at the distal end 16 of the catheter 10, as shown in
As one example of the embodiments described above, the catheter 10 can be sized at 4.5 Fr (1.5 mm). In some implementations, the catheter 10 may be sized for use in coronary arteries, and in some other implementations the catheter 10 may be sized for use in peripheral arteries.
In operation, the catheter 10 should be properly oriented within the subintimal space, so as to ensure that the guidewire, or other interventional device, extending through the lumen 20 of the catheter 10 will be deflected back into the true lumen of the blood vessel. To this end, the catheter 10 can be constructed to include a radiopaque orientation marker that uniquely indicates the orientation of the catheter shaft 12 within the subintimal space. The catheter 10 can also include a realignment assembly that can be used to reorient the catheter 10 while it resides in the subintimal space, such that the deflection of the guidewire, or other interventional device, will be made into the true lumen of the blood vessel.
Referring now to
To adjust the orientation of the catheter 10, a realignment assembly can be implemented. As shown in
In the embodiment shown in
In one embodiment, shown in
In another embodiment shown in
Referring to
Having generally described the features of the various embodiments of the catheter 10, a discussion of its general mode of operation is provided. By way of example, the operation of the various embodiments of the catheter 10 will be described with respect to treatment of chronic total occlusions in a patient. The catheter 10 can be configured as a re-entry component for re-entering a true lumen of a patient once the catheter 10 has been oriented at a desired orientation in the subintimal space. In percutaneous revascularization therapy, it is desirable to have the catheter 10 positioned after the chronic total occlusion(s) prior to re-entry in order to facilitate the procedure. As noted above, it should be appreciated by those skilled in the art that the catheter 10 can be employed for other procedures.
The catheter 10 can be positioned in the subintimal space of a patient near an occlusion designated for treatment. The deflection member 22 receives fluid from a hypotube 28 disposed within the inner lumen 26 or provided to the interior surface of the lumen 20 of the catheter shaft 12, and the fluid causes the deflection member 22 to expand from the first volume to the second volume. The fluid supplied to the deflection member 22 can be controlled by a user at a proximal end 14 of the catheter 10. As one example, the fluid can be supplied via a syringe, similar to those used in balloon catheters.
When the deflection member 22 is expanded to the second volume, it partially extends into the distal opening 24 of the catheter 10 to provide a surface that will deflect a guidewire or other interventional instrument by a projection angle, θ. It will be appreciated that during a percutaneous revascularization procedure multiple different guidewires can be interchangeably used with the catheter 10. For instance, the guidewire can be changed for a stiffer or slippery guidewire to penetrate through the subintimal tissue to facilitate reentry into the vessel lumen. The deflection surface can be positioned on an interior side of the deflection member 22 such that when the guidewire 34 extends through the distal opening 24 of the lumen 20 of the catheter 10, the guidewire 34 will make contact with and be deflected by the surface of the deflection member. Contact between the surface of the deflection member 22 and the guidewire 34 deflects the guidewire 34 through the distal opening 24 along the projection angle, θ. The guidewire 34 may also contact the angled surface 32 that provides proximal support to the guidewire 34 when deflected through the distal opening 24. The guidewire 34 can extend distally from the distal end 16 of the catheter device along the projection angle, θ. The projection angle, θ, can be determined by a user pre-operatively or during operation in order to facilitate re-entry into the true lumen beyond the occlusion and can be selectively controlled by adjusting the volume of the deflection member 22 as needed. The catheter 10 can then be advanced over the guidewire 34 into the true lumen beyond the occlusion.
During revascularization therapy using the catheter devices described in the present disclosure, it is generally desirable for the user to understand an orientation of the catheter device in order to determine the proper projection angle and to ensure the catheter device is oriented properly such that the projection angle is positioned for re-entry into the true lumen. Accordingly, the radiopaque orientation marker 60 described above and shown in
Rotation of the catheter 10 to a desired orientation can be achieved using the realignment assembly described above. By causing rotation of the rod 64 while it is interfaced with the receiving portion 66 of the catheter shaft, the catheter 10 can be rotated between different orientations. The rod 64 can be stiff and allow for increased translation of rotation applied by a user at the handle 78 located at the proximal end of the rod 64. The rod 64 can also provide support along the length of the catheter shaft 12 to rotate the catheter shaft 12 without kinking. Once the desired orientation is achieved, the rod 64 can be removed from the lumen 20 of the catheter shaft 12 and then be replaced with a guidewire for re-entry into the true lumen as discussed above.
Thus, as one non-limiting example of its use, the catheter 10 will be oriented in the proper direction beyond the occlusion using the radiopaque orientation marker 60 and the orientation rod 64. A guidewire will be advanced to the tip of the catheter 10, beside the uninflated deflection member 22. The deflection member 22 will then be expanded, angling the guidewire into the vessel lumen. The guidewire will then be advanced into the true lumen beyond the occlusion. The catheter 10 will then be advanced over the guidewire and into the true lumen to secure the position. After the guidewire has been advanced into the distal lumen, the catheter 10 in the subintimal space may be exchanged for a balloon catheter or different microcatheter while maintaining the wire position in the distal lumen.
As described, the catheter 10 can be used in CTO interventions, specifically directing a guidewire from the subintimal space towards the true lumen. The catheter 10 can also be used for directing a guidewire down a difficult to access side branch (in narrowed but not occluded arteries), for example.
Referring now to
Referring now to
One advantage of the catheter 10 described in the present disclosure is that the configuration can be constructed to maintain the outer dimensions of a microcatheter, and will have a lower risk of causing harm to the artery or the subintimal space when used in the coronary arteries. That is, the deflection member 22 and other components of the catheter 10 described in the present disclosure are located within the catheter shaft 12, and the dimensions of these components can thus be sized so as not to exceed the microcatheter outer diameter. The ability of the catheter 10 to direct the guidewire out of the distal tip also allows for the catheter 10 to be advanced across a lesion without requiring the catheter 10 to be replaced.
The catheter 10 described in the present disclosure can enable cardiologists to successfully perform percutaneous coronary interventions for complex chronic total occlusions. The catheter 10 can allow for an alternative method for directing a guidewire from the subintimal space into the true lumen that can reduce procedural costs and have a lower risk of complications as compared to current devices. Another advantage is that because the catheter 10 stays in place throughout the subintimal entry, little to no blood will track through the subintimal plane of tissue, which can otherwise occur when the a device (e.g., the CrossBoss described above) is removed and replaced with another device (e.g., the Stingray described above). As a result, the subintimal space will be prevented from filling up with blood and compressing the true lumen. In turn, the subintimal entry is made easier because the true lumen beyond the CTO is maintained. If the true lumen is compressed by blood tracking in the subintimal space, the distal lumen may become very difficult to visualize.
The present invention has been described in terms of one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 62/556,610, filed on Sep. 11, 2017, and entitled “CATHETER DEVICE CATHETER DEVICE FOR LUMEN RE-ENTRY AND METHODS FOR USE THEREOF,” which is herein incorporated by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/CA2018/051124 | 9/11/2018 | WO | 00 |
Number | Date | Country | |
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62556610 | Sep 2017 | US |