Multidirectional laser ablation conduit

Abstract

The invention provides a multidirectional laser ablation conduit, which comprises an outer tube and an inner tube which are coaxially sleeved, a laser optical fiber and a laser direction adjusting device, and is characterized in that the laser optical fiber comprises a first optical fiber layer and a second optical fiber layer which are sequentially arranged between the inner tube and the outer tube in a penetrating manner from inside to outside; the laser direction adjusting device comprises a light-transmitting tube and a direction adjusting tube, the light-transmitting tube is made of a material with the ultraviolet band light transmittance being 90% or above, the direction adjusting tube comprises a reflecting tube, the near end of the light-transmitting tube is connected to the far end of the outer tube, the reflecting tube is of a taper tube structure with openings in the two ends, the radial size is gradually increased from the near end to the far end, and the reflecting tube is arranged in the light-transmitting tube; the side wall directly faces the tail end of the second optical fiber layer; the laser emitted from the first optical fiber layer is emitted forwards from the opening of the reflecting tube, and the laser emitted from the second optical fiber layer is reflected by the side wall of the reflecting tube and then is emitted laterally along the conduit through the side wall of the light-transmitting tube. The laser ablation conduit provided by the invention can emit laser in the forward direction and the lateral direction of the conduit at the same time, and the application range of the laser ablation conduit is expanded.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a multidirectional laser ablation catheter. Background Technology

[0002] Coronary artery calcification is a very challenging condition to treat with interventional procedures and represents a bottleneck in cardiovascular disease management. Traditional methods for treating calcified plaques include high-pressure balloons, cutting balloons, spinous process balloons, and plaque rotational ablation / reduction devices. However, these devices each have limitations, and most can only treat superficial intimal calcifications, while remaining ineffective against medial calcifications, eccentric calcified nodules, or severe calcifications.

[0003] Laser ablation technology has received widespread attention as a commonly used method for treating endovascular calcification lesions. However, traditional laser ablation catheters can only emit lasers from the tip of the catheter, and are mainly used to open narrowed or occluded lesion areas. They cannot effectively treat complex lesions such as tortuous vessels, eccentric calcification, diffuse calcification, or complete coronary artery occlusion. In addition, the volume reduction range of ablation catheters that emit lasers from the tip is limited by the catheter diameter. All of these factors limit the ablation effect of the catheter, thus making the treatment limited. Summary of the Invention

[0004] Therefore, it is necessary to provide a multi-directional laser ablation conduit that can simultaneously achieve forward and lateral ablation functions.

[0005] The purpose of this invention is to provide a multidirectional laser ablation conduit, comprising: The inner tube extends axially from the proximal end to the distal end; An outer tube is coaxially sleeved outside the inner tube, and an annular receiving cavity is formed between the inner wall of the outer tube and the outer wall of the inner tube; The laser fiber is inserted into the annular cavity and includes a first fiber layer and a second fiber layer. The first fiber layer includes multiple optical fibers that extend axially along the inner tube and are uniformly arranged circumferentially on the outer side of the outer wall of the inner tube. The second fiber layer includes multiple optical fibers that extend axially along the inner tube and are uniformly arranged circumferentially on the outer side of the first fiber layer. A laser alignment device includes a light-transmitting tube and an alignment tube. The light-transmitting tube is made of a material with a light transmittance of more than 90% in the ultraviolet band. The alignment tube includes a reflector tube. The proximal end of the light-transmitting tube is connected to the distal end of the outer tube. The reflector tube is a tapered tube structure with openings at both ends, and its radial dimension gradually increases from the proximal end to the distal end. The reflector tube is disposed inside the light-transmitting tube, and the sidewall of the reflector tube faces the end of the second optical fiber layer. The laser emitted from the first optical fiber layer is emitted forward from the far end opening of the reflector tube, and the laser emitted from the second optical fiber layer is reflected by the side wall of the reflector tube and then emitted laterally along the guide tube through the side wall of the light-transmitting tube.

[0006] Furthermore, the directional tube also includes a developing sleeve, which is made of developing material and has a tapered tube structure with openings at both ends. Its proximal end wall is sealed and connected to the distal end wall of the reflector tube, and the radial dimension of the developing sleeve gradually increases from the proximal end to the distal end.

[0007] Furthermore, the angle α between the sidewall of the reflector and the axis is 30-45 degrees.

[0008] Furthermore, the light-transmitting tube is connected to the outer tube and the directional tube through the end walls at both ends, and the light-transmitting tube is made of quartz glass, magnesium fluoride, or calcium fluoride.

[0009] Furthermore, the developing sleeve is made of platinum-iridium alloy, tantalum, or titanium alloy.

[0010] Furthermore, the outer wall of the reflector tube is provided with a dielectric reflector coating, which is formed by electrodeposition of silicon dioxide or magnesium fluoride on the outer wall of the reflector tube.

[0011] Furthermore, the dielectric reflector coating has 2 to 5 layers, and the total thickness of the dielectric reflector coating is 1 μm to 5 μm.

[0012] Furthermore, the thickness tolerance of each of the dielectric reflector coatings is ±0.1 μm.

[0013] Furthermore, the sidewall of the developing sleeve has an arc-shaped structure with an opening facing inward, and the length of the developing sleeve is 1 mm to 5 mm.

[0014] Furthermore, the first optical fiber layer includes at least one layer of optical fiber, and the second optical fiber layer includes at least one layer of optical fiber.

[0015] The laser ablation catheter provided by this invention can emit laser light both forward and laterally along the catheter, making it suitable for opening narrowed or occluded lesion areas. It also has good therapeutic effects on complex lesions such as tortuous vessels, eccentric calcification, diffuse calcification, or complete coronary artery occlusion. In addition, lateral ablation can expand the ablation area of ​​the diseased vessel, thereby expanding the application range of the laser ablation catheter. Attached Figure Description

[0016] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the laser ablation conduit in the first embodiment of the present invention.

[0018] Figure 2 This is a schematic diagram of the laser ablation conduit assembly in the first embodiment of the present invention.

[0019] Figure 3 This is a cross-sectional view of the laser ablation conduit along the plane containing the axis in the first embodiment of the present invention.

[0020] Figure 4 for Figure 3 A magnified view of a portion of region A in the middle.

[0021] Figure 5 This is a schematic diagram of the directional tube in the first embodiment of the present invention.

[0022] Figure 6 This is a schematic diagram of a section of the directional pipe along its axis. Detailed Implementation

[0023] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] In this instruction manual, the proximal end refers to the end closer to the operator during the procedure, and the distal end refers to the end further away from the operator during the procedure.

[0025] refer to Figures 1 to 6 One embodiment of the present invention provides a laser ablation conduit that can emit laser light forward and laterally towards the conduit, comprising: Inner tube 1 extends axially from the proximal end to the distal end; The outer tube 2 is coaxially sleeved on the outside of the inner tube 1, and an annular receiving cavity is formed between the inner wall of the outer tube 2 and the outer wall of the inner tube 1. The laser fiber is inserted into the annular cavity and includes a first fiber layer 3 and a second fiber layer 4. The first fiber layer 3 includes multiple optical fibers that extend axially along the inner tube 1 and are uniformly arranged circumferentially on the outer side of the outer wall of the inner tube 1. The second fiber layer 4 includes multiple optical fibers that extend axially along the inner tube 1 and are uniformly arranged circumferentially on the outer side of the first fiber layer 3. The laser alignment device 5 is connected to the far end of the outer tube 2 and includes a light-transmitting tube 51 and an alignment tube 52. The light-transmitting tube 51 is made of a material with a light transmittance of more than 90% in the ultraviolet band. The alignment tube 52 includes a reflective tube 521 and a developing sleeve 522 connected together. Both the reflective tube 521 and the developing sleeve 522 are tapered tube structures with openings at both ends. The outer diameter of the reflective tube 521 gradually increases from the near end to the far end. The developing sleeve 522 is made of developing material and its outer diameter gradually decreases from the near end to the far end. The two ends of the light-transmitting tube 51 are connected to the far end of the outer tube 2 and the alignment tube 52, respectively. At least part of the reflective tube 521 is located inside the light-transmitting tube 51, and the sidewall of the reflective tube 521 is directly opposite the end of the second optical fiber layer 4. The laser emitted from the first fiber layer 3 is emitted forward along the guide tube through the openings of the inner cavity of the reflector tube 521 and the developing sleeve 522; the laser emitted from the second fiber layer 4 is reflected by the side wall of the reflector tube 521 and then emitted laterally along the guide tube through the side wall of the light-transmitting tube 51.

[0026] The laser ablation catheter provided by this invention can simultaneously emit laser light both forward and laterally. The forward-emitted laser can efficiently open occlusions and quickly restore blood flow channels; the lateral-emitted laser can further broaden the treatment area, making it particularly suitable for treating extended calcifications or plaques around the lesion. Furthermore, for complex lesions such as tortuous vessels, eccentric calcifications, diffuse calcifications, or complete coronary artery occlusion, the energy generated by the lateral-emitted laser can act evenly on the vessel wall, effectively overcoming the limitation of traditional laser ablation catheters in comprehensively covering lesions, thereby reducing the need for repeated catheter position adjustments during surgical procedures.

[0027] In this invention, the lumen of the inner tube 1 is used to insert a guide wire.

[0028] In this invention, the inner tube 1 and the outer tube 2 can be made of polymer materials such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), polyethylene (PE), polyurethane (PU), and polyamide (nylon).

[0029] The inner diameter of the inner tube 1 is 0.38 mm to 0.5 mm, and the wall thickness on one side is 0.06 mm to 0.1 mm.

[0030] The first fiber layer 3 and the second fiber layer 4 can be fiber layers composed of a single layer of optical fiber or fiber layers composed of multiple layers of optical fiber.

[0031] The optical fibers that make up the first optical fiber layer 3 and the second optical fiber layer 4 are multimode optical fibers with an outer diameter of 50 μm to 150 μm. The optical fiber includes an optical fiber core, a cladding, and a coating layer. The optical fiber core and cladding are made of quartz, and the coating layer is made of polyimide.

[0032] The optical fiber is fixed in the annular cavity between the inner tube 1 and the outer tube 2 by adhesive.

[0033] In this invention, the light-transmitting tube 51 can be made of quartz glass, magnesium fluoride, or calcium fluoride. The light-transmitting tube 51 provided by this solution has good support while also providing good laser transmission.

[0034] The reflector tube 521 and the developing sleeve 522 can be made of the same material or different materials, such as biocompatible metal materials like platinum-iridium alloy, tantalum, and titanium alloy.

[0035] Furthermore, a dielectric reflector coating can be provided on the outer wall of the reflector tube 521. The dielectric reflector coating is formed by electrodeposition of a dielectric material with high reflectivity, such as silicon dioxide or magnesium fluoride, onto the outer surface of the reflector tube 521. This solution can improve laser reflection efficiency.

[0036] Furthermore, the dielectric mirror coating can have multiple layers, with a total thickness of 1 μm to 5 μm; the thickness tolerance of each dielectric mirror coating is ±0.1 μm.

[0037] Furthermore, the dielectric reflector coating has 2 to 5 layers.

[0038] Furthermore, the angle α between the sidewall of the reflector tube 521 and the axis is 30 to 45°. This design ensures both optical reflection performance and structural stability.

[0039] Furthermore, the sidewall of the contrast-enhancing cannula 522 has an arcuate structure with the center of the ball facing the catheter axis. This catheter structure is less likely to damage blood vessels. The contrast-enhancing cannula 522 can serve as a contrast marker for the distal working area during interventional therapy, and simultaneously as the distal insertion portion of the catheter; its smooth structure minimizes the risk of vascular damage.

[0040] Furthermore, the length of the imaging sleeve 522 is 1 mm to 5 mm. Within this length range, the catheter can have good passage.

[0041] Furthermore, the light-transmitting tube 51 is connected to the end of the outer tube 2 and the directional tube 52 by means of bonding or welding.

[0042] It should be noted that, in an alternative embodiment of the present invention, the directional tube 52 may consist only of the reflector tube 521. This design simplifies the structure of the laser ablation conduit.

[0043] The above-mentioned shockwave balloon catheter is further illustrated below through specific embodiments and comparative examples. Example 1

[0044] A multidirectional laser ablation conduit includes an outer tube 2 and an inner tube 1 coaxially sleeved. A single-layer first optical fiber layer 3 and a single-layer second optical fiber layer 4 are provided in the annular receiving cavity between the inner tube 1 and the outer tube 2. The first optical fiber layer includes 19 optical fibers, and the second optical fiber layer includes 25 optical fibers. The diameter of the optical fibers is 70 μm, and the outer diameter of the conduit is 0.9 mm. A laser orientation device 5 is connected to the distal end of the outer tube, including a light-transmitting tube 51 and an orientation tube 52. The light-transmitting tube 51 is made of quartz glass, and the orientation tube 52 includes a connected reflective tube 521. The reflective tube 521 is disposed inside the light-transmitting tube 51 and is a tapered tube structure with a taper of 45°. Its outer diameter gradually increases from the proximal end to the distal end.

[0045] A 10mm long and 4mm thick bovine bone was placed in a silicone tube, which was then filled with physiological saline. An Nd:YAG 355nm laser with an output frequency of 40Hz and an energy density of 60mJ / mm² was used. 2 The energy was used to advance the laser ablation catheter in the silicone tube at a speed of 1 mm / s. The ablation time of the calcified lesion model (bovine bone) was 98s, and the minimum diameter of the lumen obtained was 1.9 mm. Example 2

[0046] A multidirectional laser ablation conduit includes an outer tube 2 and an inner tube 1 coaxially sleeved together. A single-layer first optical fiber layer 3 and a single-layer second optical fiber layer 4 are disposed in an annular receiving cavity between the inner tube 1 and the outer tube 2. The first optical fiber layer includes 19 optical fibers, and the second optical fiber layer includes 25 optical fibers. The diameter of the optical fibers is 70 μm, and the outer diameter of the conduit is 0.9 mm. A laser orientation device 5 is connected to the distal end of the outer tube, including a light-transmitting tube 51 and an orientation tube 52. The light-transmitting tube 51 is made of quartz glass, and the orientation tube 52 includes a reflective tube 521 and a developing sleeve 522 connected together. The reflective tube 521 is disposed inside the light-transmitting tube 51 and has a tapered tube structure with a taper of 45°. Its outer diameter gradually increases from the proximal end to the distal end. The developing sleeve 522 has a length of 5 mm and its outer diameter gradually decreases from the proximal end to the distal end.

[0047] A 10mm long and 4mm thick bovine bone was placed in a silicone tube, which was then filled with physiological saline. An Nd:YAG 355nm laser with an output frequency of 40Hz and an energy density of 60mJ / mm² was used. 2 The energy was used to advance the laser ablation catheter in the silicone tube at a speed of 1 mm / s. The ablation time of the calcified lesion model (bovine bone) was 178 s, and the minimum diameter of the lumen obtained was 1.9 mm. Example 3

[0048] A multidirectional laser ablation conduit includes an outer tube 2 and an inner tube 1 coaxially sleeved. An annular cavity between the inner tube 1 and the outer tube 2 contains four first fiber layers 3 and two second fiber layers 4. The first fiber layer includes 124 optical fibers, and the second fiber layer includes 100 optical fibers. The optical fiber diameter is 70 μm. The outer diameter of the conduit is 1.7 mm. A laser orientation device 5 is connected to the distal end of the outer tube, including a light-transmitting tube 51 and an orientation tube 52. The light-transmitting tube 51 is made of quartz glass, and the orientation tube 52 includes a connected reflective tube 521 located inside the light-transmitting tube 51. The reflective tube 521 is a tapered tube structure with a taper of 45°, and its outer diameter gradually increases from the proximal end to the distal end.

[0049] A 10mm long and 4mm thick bovine bone was placed in a silicone tube, which was then filled with physiological saline. An Nd:YAG 355nm laser with an output frequency of 40Hz and an energy density of 60mJ / mm² was used. 2 The energy was used to advance the laser ablation catheter in the silicone tube at a speed of 1 mm / s. The ablation time of the calcified lesion model (bovine bone) was 72s, and the minimum diameter of the lumen obtained was 3.1 mm. Example 4

[0050] A multidirectional laser ablation conduit includes an outer tube 2 and an inner tube 1 coaxially sleeved together. A single-layer first optical fiber layer 3 and a single-layer second optical fiber layer 4 are disposed in an annular receiving cavity between the inner tube 1 and the outer tube 2. The first optical fiber layer includes 19 optical fibers, and the second optical fiber layer includes 25 optical fibers. The diameter of the optical fibers is 70 μm, and the outer diameter of the conduit is 0.9 mm. A laser orientation device 5 is connected to the distal end of the outer tube, including a light-transmitting tube 51 and an orientation tube 52. The light-transmitting tube 51 is made of quartz glass, and the orientation tube 52 includes a reflective tube 521 and a developing sleeve 522 connected together. The reflective tube 521 is disposed inside the light-transmitting tube 51 and has a tapered tube structure with a taper of 30°. Its outer diameter gradually increases from the proximal end to the distal end. The developing sleeve 522 has a length of 5 mm and its outer diameter gradually decreases from the proximal end to the distal end.

[0051] A 10mm long and 4mm thick bovine bone was placed in a silicone tube, which was then filled with physiological saline. An Nd:YAG 355nm laser with an output frequency of 40Hz and an energy density of 60mJ / mm² was used. 2 The energy was used to advance the laser ablation catheter in the silicone tube at a speed of 1 mm / s. The ablation time of the calcified lesion model (bovine bone) was 129 s, and the minimum diameter of the lumen obtained was 1.7 mm. Comparative Example 1

[0052] A laser ablation conduit includes an outer tube 2 and an inner tube 1 coaxially sleeved together. A single-layer first optical fiber layer 3 and a single-layer second optical fiber layer 4 are provided in the annular receiving cavity between the inner tube 1 and the outer tube 2. The first optical fiber layer includes 19 optical fibers, and the second optical fiber layer includes 25 optical fibers. The diameter of the optical fibers is 70 μm, and the outer diameter of the conduit is 0.9 mm.

[0053] A 10mm long and 4mm thick bovine bone was placed in a silicone tube, which was then filled with physiological saline. An Nd:YAG 355nm laser with an output frequency of 40Hz and an energy density of 60mJ / mm² was used. 2 The energy was used to advance the laser ablation catheter in the silicone tube at a speed of 1 mm / s, and the ablation time of the calcified lesion model (bovine bone) was 76 s, with a minimum lumen diameter of 1.4 mm.

[0054] The experimental results of Examples 1-3 and Comparative Example 1 of this invention show that: Laser ablation conduits equipped with laser orientation devices can emit lasers laterally, resulting in a larger lumen diameter, but the ablation time is slightly longer.

[0055] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A multidirectional laser ablation conduit, characterized in that, include: The inner tube extends axially from the proximal end to the distal end; An outer tube is coaxially sleeved outside the inner tube, and an annular receiving cavity is formed between the inner wall of the outer tube and the outer wall of the inner tube; The laser fiber is inserted into the annular cavity and includes a first fiber layer and a second fiber layer. The first fiber layer includes multiple optical fibers that extend axially along the inner tube and are uniformly arranged circumferentially on the outer side of the outer wall of the inner tube. The second fiber layer includes multiple optical fibers that extend axially along the inner tube and are uniformly arranged circumferentially on the outer side of the first fiber layer. A laser alignment device includes a light-transmitting tube and an alignment tube. The light-transmitting tube is made of a material with a light transmittance of over 90% in the ultraviolet band. The alignment tube includes a reflector tube. The proximal end of the light-transmitting tube is connected to the distal end of the outer tube. The reflector tube is a tapered tube structure with openings at both ends, and its outer diameter gradually increases from the proximal end to the distal end. The reflector tube is disposed inside the light-transmitting tube, and the sidewall of the reflector tube faces the end of the second optical fiber layer. The laser emitted from the first optical fiber layer is emitted forward from the far end opening of the reflector tube, and the laser emitted from the second optical fiber layer is reflected by the side wall of the reflector tube and then emitted laterally along the guide tube through the side wall of the light-transmitting tube.

2. The multidirectional laser ablation conduit according to claim 1, characterized in that, The directional tube also includes a developing sleeve, which is made of developing material and is a tapered tube structure with openings at both ends. Its proximal end wall is sealed and connected to the distal end wall of the reflector tube. The radial dimension of the developing sleeve gradually increases from the proximal end to the distal end.

3. The multidirectional laser ablation conduit according to claim 1, characterized in that, The angle α between the sidewall of the reflector and the axis is 30-45 degrees.

4. The multidirectional laser ablation conduit according to claim 1, characterized in that, The light-transmitting tube is connected to the outer tube and the directional tube through the end walls at both ends. The light-transmitting tube is made of quartz glass, magnesium fluoride, or calcium fluoride.

5. The multidirectional laser ablation conduit according to claim 2, characterized in that, The developing sleeve is made of platinum-iridium alloy, tantalum, and titanium alloy materials.

6. The multidirectional laser ablation conduit according to claim 1, characterized in that, The outer wall of the reflector tube is provided with a dielectric reflector coating, which is formed by electrodeposition of silicon dioxide or magnesium fluoride on the outer wall of the reflector tube.

7. The multidirectional laser ablation conduit according to claim 6, characterized in that, The dielectric reflector coating has 2 to 5 layers, and the total thickness of the dielectric reflector coating is 1 μm to 5 μm.

8. The multidirectional laser ablation conduit according to claim 7, characterized in that, The thickness tolerance of the coating of each of the aforementioned dielectric reflectors is ±0.1 μm.

9. The multidirectional laser ablation conduit according to claim 2, characterized in that, The developing sleeve has an arc-shaped structure with an opening facing inward on its sidewall, and the length of the developing sleeve is 1 mm to 5 mm.

10. The multidirectional laser ablation conduit according to claim 1, characterized in that, The first optical fiber layer includes at least one layer of optical fiber, and the second optical fiber layer includes at least one layer of optical fiber.

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