Single Fiber, Excimer Laser, Lesion Crossing System

Abstract

Vascular lesion crossing device 10 includes a single optical fiber or fiber optic bundle 12 configured for insertion through a lesion in a blood vessel, the single optical fiber or fiber optic bundle being coupleable to an associated laser generator 18. The single optical fiber or fiber optic bundle has a diameter of 1.5 mm or less.

Description

[Technical field]

[0001] The following relates generally to catheter, catheter guidewire, vascular treatment, lesion treatment, and related technologies. [Background technology]

[0002] In catheter-based vascular treatment, the catheter carries one or more tools at its distal end, such as angioplasty balloons, laser opening or cutting tools for thrombectomy or atherectomy, and / or stents and associated stent deployment hardware. First, a guidewire is inserted into the blood vessel and advanced until it crosses past the treatment area (e.g., clot, thrombus, aneurysm, etc.). A catheter has a guidewire lumen and is inserted into the blood vessel along the guidewire, moving the catheter tip to the treatment area. However, complete (or near complete) occlusions in the vasculature (e.g., artery or vein) are very difficult to cross. This may force the operator (e.g., doctor or surgeon) to protrude from the main lumen of the vessel to bypass the occlusion. If the occlusion can be crossed, it generally takes a very long time for the guidewire to slowly push through the occlusion. In addition, the occlusion has a stronger material than the vessel wall, which means it is easy to cause a rupture in the vessel while attempting to cross the occlusion, which requires additional intervention to correct. Moreover, in some cases, the physician is completely unable to cross the blockage, in which case the catheter-based procedure is discontinued. Summary of the Invention [Problem to be solved by the invention]

[0003] Transverse endovascular lesions are often the most time-consuming part of an endovascular procedure. It can typically take 30 to 90 minutes to perform, even in experienced hands. In inexperienced hands, this often leads to failure of the procedure.

[0004] The following discloses specific improvements that overcome these and other problems. [Means for solving the problem]

[0005] In some embodiments disclosed herein, a vascular lesion crossing device includes a single optical fiber or fiber optic bundle configured for insertion through a lesion in a blood vessel, the single optical fiber or fiber optic bundle being coupleable to an associated laser generator, the single optical fiber or fiber optic bundle having a diameter of 1.5 mm or less.

[0006] In some embodiments disclosed herein, a vascular treatment method includes inserting an optical fiber or fiber bundle through a blood vessel to position an end of the optical fiber or fiber bundle at a lesion within the blood vessel; energizing the optical fiber or fiber bundle with a laser generator to at least partially form an opening in the lesion by laser ablation using light from the laser generator passing through the optical fiber or fiber bundle; inserting a vascular treatment device, different from the optical fiber or fiber bundle, through the blood vessel to position the vascular treatment device at the lesion within the blood vessel; and performing treatment at the lesion within the blood vessel using the vascular treatment device.

[0007] In some embodiments disclosed herein, a vascular lesion crossing device includes an optical fiber configured to be inserted through a lesion in a blood vessel, the optical fiber being coupleable to an associated laser generator, and a support catheter insertable into the blood vessel and having a central lumen sized to pass the optical fiber therethrough.

[0008] One advantage is to provide a guidewire insertion device and corresponding method of guidewire insertion that provides efficient and safe guidewire crossing of a vascular occlusion or lesion.

[0009] Another advantage is to provide such a guidewire insertion device with a support sheath to increase the ease with which the insertion device can be pushed through the lesion.

[0010] Another advantage resides in activating the guidewire insertion device to allow the insertion device to cross the lesion.

[0011] Another advantage resides in reducing the amount of time required for the guidewire insertion device to cross a lesion or occlusion.

[0012] A given embodiment may provide none, one, two, more, or all of the aforementioned advantages, and / or other advantages that will become apparent to those of ordinary skill in the art upon reading and understanding this disclosure.

[0013] The disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the disclosure. [Brief description of the drawings]

[0014] [Figure 1] 1 illustrates a schematic diagram of a crossing device according to the present disclosure; [Figure 2A] 2 illustrates a schematic diagram of another embodiment of a single optical fiber or fiber bundle of the traversing device of FIG. 1; [Figure 2B] 2 illustrates a schematic diagram of another embodiment of a single optical fiber or fiber bundle of the traversing device of FIG. 1; [Figure 2C] 2 illustrates a schematic diagram of another embodiment of a single optical fiber or fiber bundle of the traversing device of FIG. 1; [Diagram 3] 2 illustrates diagrammatically the crossing device of FIG. 1 at the point where a single optical fiber or fiber bundle has made a transverse penetration through the lesion. [Figure 4] 4 shows a schematic of a vascular treatment step after the point in FIG. 3, where the single optical fiber or fiber bundle is withdrawn and a guidewire is inserted through a transverse penetration through the lesion. [Diagram 5] FIG. 5 diagrammatically illustrates a vascular treatment stage subsequent to that of FIG. 4, in which a vascular treatment device has been inserted into the blood vessel along a guidewire and positioned to treat the lesion. [Figure 6] 2 illustrates diagrammatically how a vascular treatment method can be performed using the device of FIG. 1; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] In an intravascular procedure to treat a lesion in a blood vessel, a thin guidewire is first inserted and extended to and through the lesion. A treatment device is then inserted to the lesion with the guidewire passing through the central lumen of the treatment device. The treatment device is then manipulated to treat the lesion, for example, by removal (cutting with a rotary cutter, ablation with an excimer laser, etc.) or by remodeling with an angioplasty balloon, etc.

[0016] The passage of a guidewire through an intravascular lesion is referred to as crossing the lesion. This is typically done by mechanical force performed by a skilled vascular surgeon, but nevertheless, crossing can take well over an hour and in some cases cannot be accomplished at all, resulting in the abandonment of the intervascular procedure. Crossing a lesion using a guidewire typically relies on a perforating / shearing force applied by the tip of the guidewire to mechanically separate the lesion and allow passage. If the lesion surface is not flat or perpendicular to the trajectory of the guidewire or other crossing tool, it can deflect, leading to vessel perforation, or entering the subintimal plane.

[0017] The following discloses an approach in which, in some contemplated embodiments, lesion crossing is accomplished using an optical fiber of diameter comparable to or slightly larger than the guidewire, e.g., diameter of 0.05 inches or less. The optical fiber is inserted to position the end of a single optical fiber or fiber bundle (specifically the distal end of the fiber or fiber bundle acting as the light output end) at the lesion within the vessel, and then activated using an excimer laser operating at 308 nm, an ultraviolet (UV) laser operating at 355 nm, or another type of ablation laser. Advantageously, the laser can be the same as the laser generator used to drive the treatment device that uses laser ablation.

[0018] Since the optical fiber does not need to have significant mechanical strength (as it is not used to physically puncture the lesion), it may be fed through the support catheter. In this approach, the support catheter is inserted until it reaches the lesion, and then the optical fiber is inserted through the support catheter to extend a few millimeters from the support catheter and optically engages the lesion to perform the traversal by laser ablation. After the optical fiber and support catheter have traversed the lesion by laser ablation (optionally together with auxiliary mechanical pressure that can be provided using the support catheter), the optical fiber is withdrawn from the support catheter, and a regular guidewire is inserted through the support catheter and through the lesion through the laser ablated opening created by the optical fiber. The support catheter is then withdrawn, and the treatment device is inserted with the guidewire through the central lumen to reach the lesion, and the treatment is performed as usual.

[0019] In some embodiments disclosed herein, a single fiber is disclosed, which has advantages including providing a more focused and uniform laser beam for ablation to traverse the lesion, and optionally being able to be coupled to a laser generator using a quick connect / disconnect iris coupling. However, in other embodiments, the optical fiber can be permanently mechanically fixed to the coupling device. The optical fiber can also be a fiber bundle without a central lumen.

[0020] Although described herein primarily for crossing intravascular lesions in peripheral arteries and veins, the disclosed systems and methods may also be applied to cross lesions in other types of vasculature, such as the heart and neurovascular systems.

[0021] Referring to FIG. 1, an exemplary lesion crossing device 1 is shown in schematic form. As shown in FIG. 1, device 1 includes a single optical fiber or fiber bundle 12 insertable into a vascular treatment device 10 that is insertable into a blood vessel V to treat a lesion L (or blood clot, or occlusion, etc.) in the blood vessel V. Crossing device 10 may, for example, have a single optical fiber or fiber bundle 12 configured for insertion through a lesion in a blood vessel. Optical fiber 12 has a diameter of 1.5 mm or less (e.g., in some embodiments, ranging from 0.356 mm to 0.889 mm). Optical fiber 12 includes a distal end 14 that functions as an optical output aperture 14 and a proximal end 16 operably coupled to a laser generator 18. Laser generator 18 is configured to activate optical fiber 12 with a laser beam that passes through single optical fiber or fiber bundle 12 and exits optical output end 14 of fiber 12 to treat lesion L.

[0022] In particular, the single optical fiber or fiber bundle 12 is a lesion crossing device. It is not a vascular treatment device such as a laser ablation treatment device or a lesion removal device of the type used in thrombectomy or atherectomy. The single optical fiber or fiber bundle 12 has a small diameter of 1.5 mm or less, and the laser light 19 output from the distal end 14 of the single optical fiber or fiber bundle 12 has a small diameter comparable to the blood vessel diameter and can only form a penetrating PT in a lesion L of a similar small diameter, so it is not feasible to use it to perform thrombectomy or atherectomy. (FIG. 1 is schematic and not drawn to scale, a penetrating PT is typically on the order of 1-2 mm or less in diameter). In contrast, a laser ablation catheter of the type used in vascular treatment such as thrombectomy or atherectomy typically has a larger diameter fiber bundle to carry the high power delivered over a large cross-sectional area. The fiber bundle of a laser ablation catheter also typically has an internal lumen for receiving a guidewire. In contrast, the single optical fiber or fiber bundle 12 is a single optical fiber or a fiber bundler having a narrow diameter of no more than 1.5 mm.

[0023] On the other hand, the large diameter of the optical fiber bundle of the laser ablation catheter, together with the typical requirement for delivery into the blood vessel along a guidewire, means that the laser ablation catheter typically cannot be used to perform an initial crossing of the lesion in order to deliver the guidewire through the lesion. In contrast, a single optical fiber or fiber bundle 12 having a small diameter comparable to or slightly larger than the diameter of a typical guidewire (e.g., in the range of 0.356 mm to 0.889 mm for some standard guidewire diameters) is effective for crossing the lesion L, i.e., for creating a small diameter penetrating PT that is insufficient to constitute a clinical treatment of the lesion L (because a small diameter penetrating PT is insufficient to carry substantial blood flow), but is then suitable for passing a guidewire through the lesion L.

[0024] 2A-2C, with continued reference to FIG. 1, different embodiments of a single optical fiber or fiber bundle 12 are shown. FIG. 2A shows a side view of an optical fiber 12 (which in this embodiment constitutes a single optical fiber) having a light output end 14 with a square tip, while FIG. 2B shows an optical fiber 12 (also as a single optical fiber) having a light output end 14 with a beveled tip. FIGS. 2A and 2B show the layers comprising the optical fiber 12. The core of the optical fiber 12 comprises a glass core layer 20. A cladding layer 22 surrounds the glass core layer 20, and a polyimide buffer layer (or similar material) 24 surrounds the cladding layer 22. In some embodiments, a hydrophilic coating 26 can surround the polyimide buffer layer 24.

[0025] In contrast to the embodiment of Figures 2A-2B in which the single optical fiber or fiber bundle 12 has a single optical fiber, Figure 2C illustrates an embodiment in which the single optical fiber or fiber bundle 12 has an optical fiber bundle that does not have an internal lumen (unlike a typical laser ablation catheter). Each optical fiber 12 in the bundle can have any of the characteristics shown in Figures 2A-2B (e.g., a square tip, a beveled tip, layers 20, 22, 24, 26 shown in Figure 2B, etc.).

[0026] Referring back to FIG. 1 , the crossing device 1 further includes a support catheter 28 insertable into the blood vessel V and configured to deliver the single optical fiber or fiber bundle 12 to the lesion L. (FIG. 1 illustrates only the distal end of the support catheter 28, but as shown in FIG. 1 , it is fed through the blood vessel V into a vascular penetration and positions its end at the lesion L.) The support catheter 28 includes a central lumen 30 sized to pass the optical fiber 12 through the lesion L. A vascular treatment device 32 (e.g., a cutter, an ablation laser, a remodeling device, etc.) different from the optical fiber 12 is also configured to be delivered to the lesion L and is insertable into the blood vessel via the support catheter 12 to treat the lesion L.

[0027] 3, the crossing device 10 of FIG. 1 is again shown, but now with the transverse penetration PT of FIG. 1 laser ablated to produce an extended transverse penetration PT through the lesion L. cross FIG. 3 therefore shows the point at which the lesion L has been transected. In particular, the transverse penetration PT cross Lesion L has not yet been clinically treated because it is only about 1-2 mm in diameter and does not provide therapeutically acceptable blood flow.

[0028] 4, after the lesion L has been crossed as shown in FIG. 3, the single optical fiber or fiber bundle 12 is withdrawn from the support catheter 28 and the guidewire 36 is passed through the support catheter 28 and through the transverse penetrating PT cross 4 , is inserted through the vessel L and across the lesion L. In this illustrative example, the same support catheter 28 is used to insert the guidewire 36 that was used to insert the single optical fiber or fiber bundle 12, although in an alternative embodiment, the support catheter 28 may be withdrawn prior to insertion of the guidewire 36, in which the guidewire 36 is inserted through the vessel L and across the lesion L without the use of the support catheter 28. cross is inserted through

[0029] 5, a vascular treatment device 34, different from the single optical fiber or fiber bundle 12, is inserted along a guidewire 36 through the blood vessel to position the vascular treatment device 12 at a lesion L within the blood vessel V. The exemplary vascular treatment device 34 is a laser ablation catheter 34 having an annular optical fiber bundle 40 surrounding a central lumen 42 through which the guidewire 36 passes. The annular optical fiber bundle 40 has a distal end 44 proximal to the lesion L (now being traversed) for outputting laser light to ablate the lesion L to perform a thrombectomy, atherectomy, or other vascular treatment procedure. The proximal end 46 of the laser ablation catheter 34 is suitably connected to the same laser generator 18 used to drive the single optical fiber or fiber bundle 12 to perform the traversal, as previously described with reference to FIGS. 1 and 3. However, compared to the smaller (e.g., 1.5 mm or less) diameter of a single optical fiber or fiber bundle 12, the larger diameter of the annular optical fiber bundle 40 enables the laser ablation catheter 34 to deliver more optical power over a larger cross-sectional area to ablate a therapeutically useful amount of lesion L so as to substantially restore blood flow through blood vessel V.

[0030] 6, an exemplary embodiment of a vascular treatment method 100 using the vascular treatment device 1 is shown generally as a flow chart. In optional embodiment 101, a support catheter 28 is inserted through a blood vessel V and positions an opening where a central lumen 30 terminates at a lesion L. In operation 102, an optical fiber 12 is inserted through the blood vessel V and positions an optical output end 14 of the optical fiber 12 at the lesion L within the blood vessel V. When operation 101 is performed, the optical fiber 12 is inserted through the central lumen 30 of the support catheter 28 and reaches the lesion L.

[0031] In operation 104, the laser generator 18 is configured to activate the optical fiber 12 to form an opening (i.e., a penetration PT) in the lesion L with a laser beam. For example, the laser beam can have a wavelength in the range of 308 nm to 355 nm to activate the optical fiber 12.

[0032] In optional operation 105, once an opening has been formed in the lesion L, the optical fiber 12 and / or support catheter 28 can be retracted from the blood vessel V and a guidewire 36 can be inserted through the blood vessel V through the opening in the lesion L.

[0033] In operation 106, vascular treatment device 34 is inserted through blood vessel V to position vascular treatment device 34 at lesion L. In some embodiments, when operation 105 is performed, vascular treatment device 34 is inserted through blood vessel V along guidewire 36.

[0034] In operation 108, treatment is performed on the lesion L with the vascular treatment device 34. The treatment may include, for example, one or more of a cutting operation, a laser ablation operation, or a remodeling operation.

[0035] The present disclosure has been described with reference to the preferred embodiment. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiments be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. a single optical fiber or optical fiber bundle configured for insertion through a lesion in a blood vessel and capable of being coupled to an associated laser generator; and the single optical fiber or optical fiber bundle has a diameter of 1.5 mm or less; Vascular lesion crossing device.

2. 10. The vascular lesion crossing device of claim 1, wherein the single optical fiber or optical fiber bundle is a single optical fiber.

3. 3. The vascular lesion crossing device of claim 2, wherein the single optical fiber has a light output end with a square tip or a beveled tip.

4. The single optical fiber a glass core layer; a cladding layer surrounding the glass core layer; a polyimide buffer layer surrounding the cladding layer; 3. The vascular lesion crossing device of claim 2, comprising:

5. The vascular lesion crossing device of claim 2 , wherein the single optical fiber has a hydrophilic coating.

6. 10. The vascular lesion crossing device of claim 1, wherein the single optical fiber or optical fiber bundle is an optical fiber bundle without an internal lumen.

7. a support catheter insertable into the blood vessel and having a central lumen sized to pass the single optical fiber or optical fiber bundle; 10. The vascular lesion crossing device of claim 1, further comprising:

8. A vascular lesion crossing device according to any one of claims 1 to 7; a vascular treatment device configured to treat the lesion within the blood vessel, distinct from the single optical fiber or optical fiber bundle of the vascular lesion crossing device; A vascular treatment device having:

9. inserting the optical fiber or fiber bundle through the blood vessel to position an end of the optical fiber or fiber bundle at a lesion within the blood vessel; activating the optical fiber or fiber bundle with a laser generator to form an opening in the lesion at least in part by laser ablation with light from the laser generator passing through the optical fiber or fiber bundle; inserting the vascular treatment device, different from the optical fiber or fiber bundle, through the blood vessel to position the vascular treatment device at the lesion within the blood vessel; performing treatment for the lesion in the blood vessel using the vascular treatment device; A vascular treatment method comprising:

10. after forming the opening in the lesion, retracting the optical fiber or fiber bundle from the blood vessel and inserting a guidewire through the blood vessel and through the opening in the lesion; and the vascular treatment device is inserted through the blood vessel along the guidewire; The vascular treatment method according to claim 9.

11. The insertion of the optical fiber or fiber bundle is inserting a support catheter through the blood vessel and positioning an opening of the support catheter at the lesion; Including, The optical fiber or fiber bundle is inserted through a central lumen of the support catheter. The method for vascular treatment according to claim 10.

12. removing the support catheter from the blood vessel; inserting the vascular treatment device using the guidewire and performing treatment on the lesion; The method of claim 11 further comprising:

13. The vascular treatment method of claim 9 , wherein the treatment comprises one or more of a cutting operation, a laser ablation operation, or a remodeling operation.

14. The activation activating the at least one optical fiber with a laser having a wavelength in the range of 308 nm to 355 nm; The vascular treatment method according to claim 9, comprising:

15. an optical fiber configured for insertion through a lesion in a blood vessel and capable of being coupled to an associated laser generator; a support catheter insertable into the blood vessel and having a central lumen sized to carry the optical fiber; A vascular lesion crossing device having:

16. 16. The vascular lesion crossing device of claim 15, wherein the optical fiber has a diameter of 1.5 mm or less.

17. 16. The vascular lesion crossing device of claim 15, wherein the optical fiber has a light output end with a square tip or a beveled tip.

18. The optical fiber is a glass core layer; a cladding layer surrounding the glass core layer; a polyimide buffer layer surrounding the cladding layer; 16. The vascular lesion crossing device of claim 15, comprising:

19. 16. The vascular lesion crossing device of claim 15, wherein the optical fiber has a hydrophilic coating.

20. 20. A vascular lesion crossing device according to any one of claims 15 to 19; a vascular treatment device configured to treat the lesion within the blood vessel, the vascular treatment device being different from the single optical fiber or optical fiber bundle; A vascular treatment device having:

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