Laser catheter acoustic waves guidable with focusing chamber

Abstract

An endovascular treatment device (10) comprises: a laser catheter (12) comprising at least one optical fiber (14) extending through the laser catheter, the at least one optical fiber terminating at a laser output aperture (16); a containment sheath (18) surrounding the laser catheter and configured for containing a contrast mixture (20), the containment sheath being longitudinally movable relative to the laser catheter so as to cover or expose the laser aperture, whereby laser light output at the laser output aperture effectively initiates acoustic energy in the contrast mixture when the containment sheath covers the laser aperture; and a focusing chamber (22) arranged on the containment jacket, the focusing chamber comprising at least one acoustic energy aperture (24) on one side of the focusing chamber, the focusing chamber being configured for directing acoustic energy out of the at least one acoustic energy aperture.

Description

Technical Field

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

[0002] In catheter-based vascular treatment, laser catheters utilize a 308nm laser that is transmitted down the catheter to the distal tip, where the light ablates tissue. The laser may be used with a contrast agent mixture. The laser breaks down the contrast agent and, in the process, generates sound waves. The sound waves are emitted in a circular wave around the tip of the laser catheter. When emitted in a calcified lesion, the sound waves create cracks in the calcium. However, due to the circular nature of the wave, if there is a specific portion of the calcified lesion that does not fully encase the vessel, much of the energy generated from the pressure wave may bypass the targeted calcium.

[0003] Current laser catheter devices can generate pressure waves in the form of circular waves around the tip of the laser catheter. However, due to the circular nature of the wave, if there is a specific portion of a calcified lesion that does not completely envelop the vessel, much of the energy generated from the pressure wave may bypass the targeted calcium. Using a device that can focus the pressure wave to the desired portion can potentially improve the clinical effectiveness of the device and allow for more treatment options. However, the device also amplifies the amplitude of the pressure wave in a specific direction, allowing the device to potentially break up a larger amount of calcium deposits.

[0004] The following discloses some improvements to overcome these and other problems. Summary of the invention

[0005] In some embodiments disclosed herein, an intravascular treatment device includes: a laser catheter, which includes at least one optical fiber extending through the laser catheter, the at least one optical fiber terminating at a laser output hole; a containment sheath, which surrounds the laser catheter and is configured to contain a contrast agent mixture, the containment sheath being able to move longitudinally relative to the laser catheter so as to cover or expose the laser hole, whereby when the containment sheath covers the laser hole, laser light output at the laser output hole effectively induces acoustic energy in the contrast agent mixture; and a focusing chamber, which is arranged on the containment sheath, the focusing chamber including at least one acoustic energy hole located on one side of the focusing chamber, the focusing chamber being configured to guide the acoustic energy out of the at least one acoustic energy hole.

[0006] In some embodiments disclosed herein, an intravascular treatment device includes: a laser catheter, which includes at least one optical fiber extending through the laser catheter, the at least one optical fiber terminating at a laser output hole; a containment sheath, which surrounds the laser catheter and is configured to contain a contrast agent mixture, the containment sheath being able to move longitudinally relative to the laser catheter to cover or expose the laser hole, whereby when the containment sheath covers the laser hole, the laser output at the laser output hole effectively induces acoustic energy in the contrast agent mixture; and a focusing chamber, which is arranged on the containment sheath, the focusing chamber including at least one acoustic energy hole located on one side of the focusing chamber, the focusing chamber being configured to guide acoustic energy out of the at least one acoustic energy hole. The focusing chamber is configured to move longitudinally along the length of the laser catheter so as to align the at least one acoustic energy hole longitudinally with the laser output hole.

[0007] In some embodiments disclosed herein, an intravascular treatment method includes: inserting a catheter assembly including a laser catheter surrounded by a containment sheath and also including a focusing chamber into a blood vessel so as to position the focusing chamber at an intravascular treatment site having a calcified occlusion; and after the insertion, treating the calcified occlusion by simultaneously performing the following operations: inputting a laser into the laser catheter so as to emit the laser at a laser hole located inside the focusing chamber; allowing a contrast agent mixture to flow into the focusing chamber through the containment sheath, whereby the laser induces acoustic energy in the contrast agent mixture located within the containment sheath; and directing the acoustic energy out of the acoustic energy hole of the focusing chamber through the focusing chamber.

[0008] One advantage resides in directing acoustic energy to an occlusion in a blood vessel.

[0009] Another advantage resides in the use of the focusing chamber with a laser catheter to direct acoustic energy to an occlusion in a blood vessel.

[0010] Another advantage resides in the use of a focusing chamber with holes to direct acoustic energy to an occlusion in a blood vessel.

[0011] Another advantage resides in moving the focusing chamber along the length of the laser catheter to direct the acoustic energy to an occlusion in a blood vessel.

[0012] A given embodiment may provide none, one, two, more, or all of the advantages described above, and / or may provide other advantages that will become apparent to one of ordinary skill in the art upon reading and understanding the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0014] Figure 1 A vascular treatment device according to the present disclosure is schematically shown.

[0015] Figures 2 to 4 Shows Figure 1 Embodiment of a focusing chamber of a device.

[0016] Figure 5 Schematically shows the use of Figure 1 Device for vascular treatment methods. DETAILED DESCRIPTION

[0017] The following relates to an intravascular laser ablation system in which a contrast agent mixture is broken down by a laser, thereby generating acoustic waves that can debulk hardened calcium deposits. The contrast agent mixture is also used to provide imaging contrast. To generate the acoustic waves, the contrast agent includes a substance that absorbs the laser (e.g., iodine in the case of a 308 nm excimer laser), and an outer sheath surrounding the laser catheter is used to contain the contrast agent mixture. The outer sheath can be retracted to expose the laser directly to the clot in order to operate in a conventional laser ablation mode, or moved forward to contain the contrast agent in an acoustic wave-mediated calcification procedure. The outer sheath is typically a plastic material that confines the contrast agent mixture but transmits the acoustic waves.

[0018] The following provides an acoustic energy focusing chamber in the form of a stainless steel hypotube (i.e., a tube with thin walls) with an opening on the side. The acoustic energy focusing chamber is used to concentrate the sound waves and preferentially emit them out of the side opening. This both increases the sound energy directed out of the opening and reduces or eliminates the sound energy flowing in other directions. By rotating the conduit carrying the acoustic energy focusing chamber, a directional emission of the sound energy can be achieved.

[0019] In one embodiment, the acoustic energy focusing chamber is mounted at the end of an existing outer sheath used to contain the contrast agent mixture during calcium debulking. In another embodiment, the acoustic energy focusing chamber is mounted on a third concentric catheter surrounding the outer sheath (which in turn surrounds the laser catheter).

[0020] A further modification would be to provide for rotation of the catheter carrying the acoustic energy focusing chamber. This is simple and can be achieved by adding a knob or the like to enable rotation of the outer sheath or an additional sheath added around the outer sheath.

[0021] The exemplary acoustic energy focusing chamber is a tube, but other acoustic energy focusing chamber geometries are also contemplated, such as shaping the acoustic energy focusing chamber to enhance the concentration of the acoustic energy. The exemplary acoustic energy focusing chamber has an open distal end, but in variant embodiments, the distal end can be closed by a normally closed hinged door that will be opened during the passage of the acoustic energy focusing chamber over the laser catheter, but will spring back closed when the acoustic energy focusing chamber moves beyond the end of the laser catheter.

[0022] Further variations include acoustic waves generated by another mechanism, such as rapid reciprocating motion of a laser catheter within an outer sheath.

[0023] Reference Figure 1 , schematically shows an exemplary intravascular treatment device 10 that can be inserted into a blood vessel for treating a lesion (or clot, occlusion, etc.) in the blood vessel. Figure 1 As shown, the device 10 includes a laser catheter 12, which includes at least one optical fiber 14 extending through the laser catheter 12 (at Figure 1 The at least one optical fiber terminates in a laser output hole 16 (shown as an optical fiber ring).

[0024] The containment sheath 18 surrounds the laser catheter 12 and is configured to contain a contrast medium mixture 20 (i.e., iodine) ( Figure 1 16). The containment sheath 18 can be longitudinally moved relative to the laser catheter 12 to cover or expose the laser hole 16. When the containment sheath 18 covers the laser hole 16, the laser output at the laser output hole 16 effectively induces acoustic energy in the contrast agent mixture 20. The laser light can be generated by a laser generator (not shown) and can have a wavelength of 308 nm.

[0025] Figure 1 Also shown is a control 28 (ie, a knob) disposed at the proximal end of the device 10. The control 28 is configured for rotating the focusing chamber 22 about the laser catheter 18.

[0026] Reference by inclusion Figure 1 , Figure 2 The focusing chamber 22 is shown to be arranged on the housing jacket 18 (the focusing chamber 22 is Figure 1 18 (shown schematically as an elongated rectangle in the drawings). The focusing chamber 22 comprises a stainless steel tube. The focusing chamber 22 comprises at least one acoustic energy hole 24 located on one side of the focusing chamber 22. The focusing chamber 22 is configured to direct acoustic energy out of the at least one acoustic energy hole 24. The focusing chamber 22 does not surround the periphery of the laser catheter 12. The portion of the laser catheter 12 without the focusing chamber 22 will allow the pressure wave to leave more easily. In one example, the focusing chamber 22 is attached to the outside of the containment sheath 18. In another example, the focusing chamber 22 is attached to an additional sheath 26 ( Figure 1 ).

[0027] At least one acoustic energy hole 24 includes (i) at least one opening, or (ii) at least one acoustic energy transmission window. Figure 3 As shown, the focusing chamber 22 includes a normally closed hinged door 30 ( Figure 3The door 30 is shown open) and is configured to cover the at least one acoustic energy aperture 24 when acoustic energy is not being transmitted through the laser catheter 12. To direct the acoustic energy out of the at least one acoustic energy aperture 24, the focusing chamber 22 is configured to move longitudinally along the length of the laser catheter 12 so as to longitudinally align the at least one acoustic energy aperture 24 with the laser output aperture 16 of the laser catheter 12.

[0028] like Figure 3 As shown, the focusing chamber 22 allows the device 10 to potentially more effectively treat areas with heavy calcium and reduce possible treatment in areas that do not need treatment. The focusing chamber 22 can allow a physician to direct the pressure waves (labeled as reference numeral 32) generated within the focusing chamber 22 to the desired treatment area. Moreover, the pressure waves can be amplified in a desired direction and reduced in areas that may not need to be treated as much.

[0029] Figure 4 Schematic diagram of hydrophone test of device 10 is shown. Figure 4 As shown, three hydrophones (labeled as reference numerals 1, 2, and 3) are positioned around the catheter, offset 45 degrees relative to the center of the laser catheter 12. Hydrophone 3 is directly in line with the outlet of the focusing chamber 22 (i.e., 0 degrees), hydrophone 2 is offset 45 degrees relative to the outlet of the focusing chamber 22, and hydrophone 1 is offset 90 degrees relative to the outlet. Tests were conducted without the focusing chamber 22 around the end of the laser catheter 12 (as a control) and with the focusing chamber 22 around the end. The test results show that the amplitude changes of the hydrophones are -51% for hydrophone 1, +20% for hydrophone 2, and +55% for hydrophone 3. These results demonstrate that the use of the focusing chamber 22 can amplify the amplitude of the sound wave in the direction in which the sound wave is pointed and attenuate the sound wave in the area away from the outlet.

[0030] Reference Figure 5 , an exemplary embodiment of an intravascular treatment method or process 100 using the device 10 is schematically shown as a flow chart. At operation 102, the device 10 is inserted into a blood vessel so as to position the focusing chamber 22 at an intravascular treatment site having a calcified occlusion. The calcified occlusion is then treated. To this end, at operation 104, a laser is input into the laser catheter 12 so as to emit the laser at the laser hole 24 located inside the focusing chamber 22. At operation 106, a contrast agent mixture 20 is caused to flow from the containment sheath 18 into the focusing chamber 22. The laser induces acoustic energy in the contrast agent mixture 20 located in the containment sheath 18. At operation 108, the focusing chamber 22 directs the acoustic energy out of the acoustic energy hole 24 and to the calcified occlusion.

[0031] The device 10 can potentially be used in peripheral, coronary or any part of the body in applications for breaking up calcium or hard materials in the body. The device 10 can potentially be used in indeed any treatment that requires breaking up hard materials via pressure waves.

[0032] The present disclosure has been described with reference to preferred embodiments. Various modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiments be interpreted as including all such modifications and alterations as long as they fall within the scope of the appended claims or their equivalents.

Claims

1. An intravascular treatment device (10), comprising: A laser catheter (12) comprising at least one optical fiber (14) extending through the laser catheter, the at least one optical fiber terminating at a laser output aperture (16); a containment sheath (18) surrounding the laser catheter and configured to contain a contrast medium mixture (20), the containment sheath being longitudinally movable relative to the laser catheter to cover or uncover the laser aperture, whereby when the containment sheath covers the laser aperture, laser light output at the laser output aperture effectively induces acoustic energy in the contrast medium mixture; as well as A focusing chamber (22) is arranged on the containing jacket, the focusing chamber comprising at least one acoustic energy hole (24) located on one side of the focusing chamber, the focusing chamber being configured to guide the acoustic energy out of the at least one acoustic energy hole.

2. The device (10) according to claim 1, wherein: The at least one acoustic energy aperture (24) of the focusing chamber (22) comprises at least one opening or at least one acoustic energy transmission window.

3. The device (10) according to any one of claims 1 and 2, wherein: The focusing chamber (22) comprises a stainless steel tube.

4. The device (10) according to any one of claims 1 to 3, wherein: The focusing chamber (22) is attached to the exterior of the containment jacket (18).

5. The device (10) according to any one of claims 1 to 3, wherein: The device also includes an additional sheath (26) surrounding the containment sheath (18), the focusing chamber (22) being attached to the additional sheath.

6. The device (10) according to any one of claims 1 to 5, wherein: The device also includes: A control (28) is disposed at the proximal end of the device and is configured to rotate the focusing chamber (22) around the laser catheter (12).

7. The device (10) according to any one of claims 1 to 6, wherein: The focusing chamber (22) is configured to move longitudinally along the length of the laser catheter (12) to longitudinally align the at least one acoustic energy aperture (24) with the laser output aperture (16).

8. The device (10) according to any one of claims 1 to 7, wherein: The focusing chamber (22) includes a normally closed hinged door (30) located at a distal end of the focusing chamber.

9. An intravascular treatment device (10), comprising: A laser catheter (12) comprising at least one optical fiber (14) extending through the laser catheter, the at least one optical fiber terminating in a laser output aperture (16); a containment sheath (18) surrounding the laser catheter and configured to contain a contrast medium mixture (20), the containment sheath being longitudinally movable relative to the laser catheter to cover or uncover the laser aperture, whereby when the containment sheath covers the laser aperture, laser light output at the laser output aperture effectively induces acoustic energy in the contrast medium mixture; as well as a focusing chamber (22) disposed on the containment jacket, the focusing chamber comprising at least one acoustic energy hole (24) located on one side of the focusing chamber, the focusing chamber being configured to direct the acoustic energy out of the at least one acoustic energy hole; The focusing chamber is configured to move longitudinally along the length of the laser catheter (12) so as to align the at least one acoustic energy aperture (24) longitudinally with the laser output aperture (16).

10. The device (10) according to claim 9, wherein: The at least one acoustic energy aperture (24) of the focusing chamber (22) comprises at least one opening or at least one acoustic energy transmission window.

11. The device (10) according to any one of claims 9 and 10, wherein: The focusing chamber (22) comprises a stainless steel tube.

12. The device (10) according to any one of claims 9 to 11, wherein: The focusing chamber (22) is attached to the exterior of the containment jacket (18).

13. The device (10) according to any one of claims 9 to 11, wherein: The device also includes an additional sheath (26) surrounding the containment sheath (18), the focusing chamber (22) being attached to the additional sheath.

14. The device (10) according to any one of claims 9 to 13, wherein: The device also includes: A control (28) is disposed at the proximal end of the device and is configured to rotate the focusing chamber (22) around the laser catheter (12).

15. The device (10) according to any one of claims 9 to 14, wherein: The focusing chamber (22) includes a normally closed hinged door (30) located at a distal end of the focusing chamber.

16. An intravascular treatment method (100), comprising: inserting a catheter assembly including a laser catheter (12) surrounded by a containment sheath (18) and also including a focusing chamber (22) into a blood vessel so as to position the focusing chamber at an intravascular treatment site having a calcified occlusion; and After insertion, the calcified occlusion is treated by simultaneously performing the following procedures: Inputting laser light into the laser guide tube so as to emit the laser light at a laser hole (24) disposed inside the focusing chamber; causing a contrast agent mixture (20) to flow through the containment sheath into the focusing chamber, whereby the laser induces acoustic energy in the contrast agent mixture located in the containment sheath; as well as The acoustic energy is directed through the focusing chamber and out of an acoustic energy hole of the focusing chamber.

17. The method (100) of claim 16, wherein: The method further comprises: The laser aperture (24) disposed inside the focusing chamber (22) is aligned with the laser output aperture (16) of the laser catheter (12) to direct the acoustic energy.

18. The method (100) according to any one of claims 16 and 17, wherein: The method further comprises: The focusing chamber (22) is rotated about the laser catheter (12) to direct the acoustic energy.

19. The method (100) according to any one of claims 16 to 18, wherein: The frequency of the laser is 308 nm.

20. The method (100) according to any one of claims 16 to 19, wherein: The contrast agent (20) includes iodine.

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