High-strength calcified plaque fragmentation device

Abstract

The high-strength calcified plaque fragmentation device comprises a shock wave guide pipe and a main machine, and one end of the shock wave guide pipe is installed on the main machine; the shock wave catheter comprises a catheter body, a guide wire cavity, an optical fiber and a balloon, the balloon is located at the far end of the catheter body, the guide wire cavity and the optical fiber are located in the catheter body, and a light outlet of the optical fiber is located in the balloon. The host comprises a laser used for emitting laser to the optical fiber. According to the high-strength calcified plaque breaking device, shock waves are generated in a laser mode to beat the high-strength calcified plaque in the blood vessel, calcification can be broken and stripped, and therefore the blood vessel compliance is improved, and the treatment efficiency is improved. The optical fiber light outlet emits laser, the laser is combined with liquid in the balloon to generate shock waves, cavitation bubbles generated along with the shock waves can be limited in the balloon, the probability that the balloon swells, collapses and is broken due to the shock waves and the cavitation bubbles is small, complications can be reduced, and safety is high.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to a high-strength calcified plaque fragmentation device. Background Art

[0002] With the change of lifestyle and the arrival of an aging society, the incidence of cardiovascular diseases has increased year by year. Intravascular atherosclerotic plaque is a high-intensity calcified plaque and is one of the main causes of cardiovascular disease. At present, traditional treatments such as drug therapy, balloon angioplasty and stent implantation have certain limitations. Drug therapy has limited effect, and balloon angioplasty and stent implantation may cause complications such as restenosis of blood vessels.

[0003] In the prior art, intravascular electrolithotripsy uses electric discharge to generate shock waves to break calcium deep in the arterial wall. This technology uses the electric arc on the electrode ring to cavitate the surrounding fluid, and the bubbles formed generate shock waves when they burst. Although this technology is widely used in clinical practice, it has certain drawbacks. The outer diameter of the treatment tube is relatively large. The smallest outer diameter of the electric shock wave catheter in the industry is 1.2mm. It is difficult for a catheter of this diameter to enter a smaller space of calcified areas. According to statistics, the average inner diameter of blood vessels in many calcified areas is only 0.8mm. It is difficult to achieve intravascular electrolithotripsy at such a diameter.

[0004] Therefore, a more efficient and safer treatment method is needed to solve the problems of lumen stenosis caused by severe calcification and inability of catheter to pass, so as to break and peel off the calcification and increase vascular compliance. Summary of the invention

[0005] The purpose of the present invention is to provide an efficient and safe fragmentation device to break up high-intensity calcified plaques in blood vessels.

[0006] The present invention is implemented as follows: a high-intensity calcified plaque fragmentation device includes a shock wave guide tube and a main unit, one end of the shock wave guide tube is installed on the main unit; the shock wave guide tube includes a catheter body, a guide wire cavity, an optical fiber and a balloon, the balloon is located at the distal end of the catheter body, the guide wire cavity and the optical fiber are located inside the catheter body, and the light outlet of the optical fiber is located in the balloon; the main unit includes a laser, and the laser is used to emit laser to the optical fiber.

[0007] Furthermore, the host also includes a driving mechanism, which is transmission-connected to the optical fiber, and can drive the optical fiber to rotate and / or move.

[0008] Furthermore, a metal target is provided inside the balloon or on the inner wall of the balloon to enhance the intensity of the shock wave.

[0009] Furthermore, the shock waveguide tube includes a plurality of optical fibers, which are arranged around the periphery of the guide wire cavity, and the tip of each optical fiber is plated with a microlens, which is used to focus the emitted laser onto the metal target.

[0010] Furthermore, the metal target is annular and is sleeved on the periphery of the guidewire cavity; a plurality of conical protrusions are provided on the metal target, the number of the protrusions is consistent with the number of optical fibers and corresponds one-to-one with the microlenses at the tip of the optical fiber, and the apex of the protrusion is located at the focus of the corresponding microlens.

[0011] Furthermore, the tip of the optical fiber is connected to a metal mesh bag, and a plurality of thorn-like protrusions are distributed on the metal mesh bag.

[0012] Furthermore, the tip of the optical fiber is plated with a microlens and connected to a metal mesh bag, the metal mesh bag covers the periphery of the microlens, the metal mesh bag is provided with a thorn-shaped protrusion facing the center of the optical fiber, and the microlens can focus the outgoing laser onto the thorn-shaped protrusion.

[0013] Furthermore, a plurality of optical fibers are arranged in the catheter, and the plurality of optical fibers form an optical fiber bundle. The end of the optical fiber bundle is plated with a lens as a whole. An annular metal target is sleeved on the periphery of the guide wire cavity, and a conical protrusion is provided on the metal target, and the protrusion corresponds to the end of the optical fiber bundle.

[0014] Furthermore, a plurality of optical fibers are arranged in the shock waveguide tube, and the plurality of optical fibers form an optical fiber bundle. A lens is plated on the end of the optical fiber bundle as a whole. An annular metal target is sleeved on the periphery of the guide wire cavity, and a plurality of conical protrusions are provided on the metal target. The driving mechanism can drive the optical fiber bundle to rotate along the periphery of the guide wire cavity, thereby making the lens correspond to the protrusions at different positions.

[0015] Furthermore, each optical fiber tip is provided with a hemispherical structure capable of focusing the emitted laser laterally, and a plurality of metal target protrusions are provided on the inner wall of the balloon.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] The high-intensity calcified plaque fragmentation device provided by the present invention uses a laser to generate shock waves to hit the high-intensity calcified plaques in the blood vessels, which can cause the calcification to break and peel off, thereby increasing the compliance of the blood vessels and improving the treatment efficiency. The optical fiber light outlet emits laser, and the laser combines with the liquid in the balloon to generate shock waves. The cavitation generated by the shock wave can be confined in the balloon. The probability of the balloon collapsing and breaking due to the shock wave and cavitation expansion is low, which can reduce the occurrence of complications and has higher safety. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 This is a schematic structural diagram of a high-strength calcified plaque fragmentation device provided in Example 1 of the present invention;

[0019] Figure 2 It is a structural schematic diagram of a high-strength calcified plaque fragmentation device provided in the second embodiment of the present invention;

[0020] Figure 3 This is a schematic diagram of the structure of the optical fiber tip of a high-intensity calcified plaque fragmentation device provided in Embodiment 3 of the present invention;

[0021] Figure 4 This is a schematic diagram of the structure of the optical fiber tip of a high-intensity calcified plaque fragmentation device provided in Embodiment 4 of the present invention;

[0022] Figure 5 This is a schematic diagram of the structure of a high-strength calcified plaque fragmentation device provided in Embodiment 5 of the present invention;

[0023] Figure 6 yes Figure 5 A schematic cross-sectional view of the optical fiber position in the device shown;

[0024] Figure 7 yes Figure 5 A schematic cross-sectional view of the metal target position in the device shown;

[0025] Figure 8 This is a schematic structural diagram of a high-strength calcified plaque fragmentation device provided in Example 6 of the present invention;

[0026] Fig. 9 yes Figure 8 A schematic cross-sectional view of the optical fiber position in the device shown;

[0027] Fig.10 yes Figure 8 A schematic cross-sectional view of the metal target position in the device shown;

[0028] Fig.11 This is a schematic structural diagram of a high-strength calcified plaque fragmentation device provided in Embodiment 7 of the present invention;

[0029] Fig.12 This is a schematic structural diagram of a high-strength calcified plaque fragmentation device provided in Embodiment 8 of the present invention;

[0030] Fig.13 yes Fig.12 A schematic diagram of the side structure of the optical fiber in the device shown;

[0031] Fig.14 yes Fig.12Schematic cross-section of the optical fiber position in the device shown. DETAILED DESCRIPTION

[0032] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0033] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "front", "rear", "vertical", "horizontal", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention; the terms "first", "second", and "third" are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance; in addition, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be directly connected, or indirectly connected through an intermediate medium, or it can be a connection between the two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0034] Embodiment 1:

[0035] See also Figure 1 , showing a high-strength calcified plaque fragmentation device provided in this embodiment, including a shock wave guide tube and a main unit, one end of the shock wave guide tube is installed on the main unit, in this embodiment, the shock wave guide tube is plug-connected to the main unit, in addition to the plug-in method, other connection methods such as socket connection and threaded connection can also be used.

[0036] The shock wave catheter comprises a catheter body, a guidewire cavity 1, an optical fiber 2 and a balloon 3. The balloon 3 is located at the end of the catheter body away from the main machine. The guidewire cavity 1 and the optical fiber 2 are located inside the catheter body. The optical fiber 2 is attached to the outside of the guidewire cavity 1, and the light outlet of the optical fiber 2 is located in the balloon 3. One or more optical fibers 2 can be provided. When multiple optical fibers 2 are provided, the multiple optical fibers 2 are arranged around the periphery of the guidewire cavity 1.

[0037] The host includes a laser, which is used to emit 355nm laser to the optical fiber 2. The optical fiber 2 transmits the laser to the light outlet at its tip to generate a shock wave.

[0038] The high-intensity calcified plaque fragmentation device provided in this embodiment uses a laser to generate shock waves to hit the high-intensity calcified plaques in the blood vessels, which can cause the calcification to break and peel off, thereby increasing the compliance of the blood vessels and improving the treatment efficiency. The light outlet of the optical fiber 2 emits laser, and the laser combines with the liquid in the balloon 3 to generate shock waves. The cavitation energy generated by the shock wave can be confined in the balloon 3. The probability of the balloon 3 expanding, collapsing and breaking due to the shock wave and cavitation is small, which can reduce the occurrence of complications and has higher safety; and can achieve a higher peak pressure (200atm) than that reported by E-IVL (50atm in the coronary artery and 100atm in the peripheral blood vessel).

[0039] Embodiment 2:

[0040] This embodiment provides a high-strength calcified plaque fragmentation device, see Figure 2 The fragmentation device of this embodiment is based on the first embodiment, and a microlens 4a is plated on the tip of each optical fiber 2. The microlens 4a can focus the outgoing laser to increase the energy density of the laser, thereby generating a stronger shock wave and further improving the treatment efficiency.

[0041] Embodiment three:

[0042] This embodiment provides a high-strength calcified plaque fragmentation device, see Figure 3 The fragmentation device of this embodiment is based on the first embodiment. A metal mesh bag 5 is connected to the tip of each optical fiber 2. A plurality of thorn-like protrusions 51 are distributed on the metal mesh bag 5. The thorn-like protrusions 51 can act as a target, enhance the intensity of the shock wave, and further improve the treatment efficiency.

[0043] Embodiment 4:

[0044] This embodiment provides a high-strength calcified plaque fragmentation device, see Figure 4 The fragmentation device of this embodiment is based on the embodiment 1. A microlens 4a is plated on the tip of each optical fiber 2 and is connected to a metal mesh bag 5. The metal mesh bag 5 covers the periphery of the microlens 4a. A thorn-like protrusion 51 facing the center of the optical fiber is provided on the metal mesh bag 5. The thorn-like protrusion 51 can act as a target, and the microlens 4a can focus the emitted laser onto the thorn-like protrusion 51, thereby achieving a greater energy density, thereby generating a stronger shock wave and further improving the treatment efficiency.

[0045] Embodiment five:

[0046] This embodiment provides a high-strength calcified plaque fragmentation device, see Figures 5 to 7 The fragmentation device of this embodiment is provided with a metal target 6 in addition to the embodiment 2.

[0047] The metal target 6 is annular and is sleeved on the periphery of the guidewire cavity 1. The metal target 6 is provided with a plurality of conical protrusions 61. The number of protrusions 61 is consistent with the number of optical fibers 2 and corresponds one-to-one with the microlenses 4a at the tip of the optical fibers 2. The apex of the protrusion 61 is located at the focus of the corresponding microlens 4a. The laser emitted from each optical fiber 2 is focused on the apex of the conical protrusion 61, which can increase the intensity of the shock wave generated by the laser and further improve the treatment efficiency.

[0048] Embodiment six:

[0049] This embodiment provides a high-strength calcified plaque fragmentation device, see Figures 8 to 10 The fragmentation device of this embodiment is based on the first embodiment, and multiple optical fibers 2 are combined into an optical fiber bundle 20. The optical fiber bundle is located on the upper side of the guide wire cavity 1 and is tangent to the guide wire cavity 1. The end of the optical fiber bundle 20 is plated with a lens 4b. The guide wire cavity 1 is located on the lower side of the catheter body and is close to the inner wall of the catheter body. An annular metal target 6 is sleeved on the periphery of the end of the guide wire cavity 1, and a conical protrusion 61 is provided on the metal target 6.

[0050] The protrusion 61 corresponds to the lens 4b at the end of the optical fiber bundle 20. The laser emitted from the optical fiber bundle 20 can be focused by the lens 4b onto the protrusion 61 of the metal target 6, thereby increasing the intensity of the shock wave generated by the laser and further improving the treatment efficiency.

[0051] Embodiment seven:

[0052] This embodiment provides a high-strength calcified plaque fragmentation device, see Fig.11 The fragmentation device of this embodiment is additionally provided with a driving mechanism on the basis of the sixth embodiment, and a plurality of conical protrusions 61 are provided on the metal target 6.

[0053] The driving mechanism can drive the optical fiber bundle 20 to be connected to the optical fiber bundle 20, and the driving mechanism can output rotational motion, thereby driving the optical fiber bundle 20 to rotate along the periphery of the guidewire cavity 1, and then making the lens 4b correspond to the protrusions 61 at different positions, so that the optical fiber bundle 20 can be rotated to the position of the calcified lesion in a targeted manner, thereby improving the treatment efficiency. In this embodiment, a motor is used as the power source of the driving mechanism. In other embodiments, the driving method can also be mechanical traction, electric drive, hydraulic or pneumatic system, electromagnetic drive, etc.

[0054] Embodiment eight:

[0055] This embodiment provides a high-strength calcified plaque fragmentation device, see Figure 12 to Figure 14 The fragmentation device of this embodiment is additionally provided with a driving mechanism on the basis of the first embodiment. At the same time, a hemispherical structure 7 capable of laterally focusing the outgoing laser is provided at the tip of each optical fiber 2, and a plurality of metal target protrusions 62 are provided on the inner wall of the balloon 3.

[0056] One or more optical fibers 2 may be provided. When multiple optical fibers 2 are provided, the multiple optical fibers 2 surround the guidewire cavity 1 in one or more circles. The hemispherical structure 7 at the tip of the optical fiber 2 can focus the emitted laser laterally. When there is only one optical fiber 2, a driving mechanism is connected to the optical fiber 2, and the driving mechanism can output rotational motion and linear motion. In this embodiment, the power source of the driving mechanism is a motor. In other embodiments, the driving method can also be mechanical traction, electric drive, hydraulic or pneumatic system, electromagnetic drive, etc. The optical fiber 2 can be accurately controlled to rotate along the guidewire cavity 1 and move back and forth in the balloon 3, so that the light beam emitted by the optical fiber 2 can be focused laterally onto any metal target protrusion on the balloon 3, thereby realizing comprehensive 360-degree shock wave therapy. Fig.12 As shown, when the guidewire cavity 1 is surrounded by one or more circles of optical fiber 2, the optical fiber 2 corresponds one-to-one with the metal target protrusion 62 on the balloon 3, so that the light beam emitted by each optical fiber 2 can be focused laterally onto the corresponding metal target protrusion 62 on the balloon 3, realizing comprehensive 360-degree shock wave therapy.

[0057] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. A high-strength calcified plaque fragmentation device, characterized in that: The invention comprises a shock wave catheter and a host, wherein one end of the shock wave catheter is mounted on the host; the shock wave catheter comprises a catheter body, a guide wire cavity, an optical fiber and a balloon, wherein the balloon is located at the distal end of the catheter body, the guide wire cavity and the optical fiber are located inside the catheter body, and the light outlet of the optical fiber is located inside the balloon; the host comprises a laser, and the laser is used to emit laser light to the optical fiber.

2. The high-strength calcified plaque fragmentation device according to claim 1, characterized in that: The host also includes a driving mechanism, which is transmission-connected to the optical fiber and can drive the optical fiber to rotate and / or move.

3. The high-strength calcified plaque fragmentation device according to claim 1, characterized in that: A metal target is arranged inside the balloon or on the inner wall of the balloon to enhance the intensity of the shock wave.

4. The high-strength calcified plaque fragmentation device according to claim 3, characterized in that: The shock waveguide tube comprises a plurality of optical fibers, which are arranged around the periphery of the guide wire cavity. The tip of each optical fiber is plated with a microlens, which is used to focus the emitted laser onto the metal target.

5. The high-strength calcified plaque fragmentation device according to claim 4, characterized in that: The metal target is annular and is sleeved on the periphery of the guidewire cavity; a plurality of conical protrusions are provided on the metal target, the number of which is consistent with the number of optical fibers and corresponds one-to-one to the microlenses at the tip of the optical fiber, and the apex of the protrusion is located at the focus of the corresponding microlens.

6. The high-strength calcified plaque fragmentation device according to claim 1, characterized in that: The tip of the optical fiber is connected to a metal net bag, and a plurality of thorn-like protrusions are distributed on the metal net bag.

7. The high-strength calcified plaque fragmentation device according to claim 1, characterized in that: The tip of the optical fiber is plated with a microlens and connected with a metal net bag, the metal net bag covers the periphery of the microlens, and the metal net bag is provided with a thorn-shaped protrusion facing the center of the optical fiber, and the microlens can focus the emitted laser onto the thorn-shaped protrusion.

8. The high-strength calcified plaque fragmentation device according to claim 1, characterized in that: A plurality of optical fibers are arranged in the catheter, and the plurality of optical fibers form an optical fiber bundle. The end of the optical fiber bundle is plated with a lens as a whole. An annular metal target is sleeved on the periphery of the guidewire cavity, and a conical protrusion is provided on the metal target, and the protrusion corresponds to the end of the optical fiber bundle.

9. The high-strength calcified plaque fragmentation device according to claim 2, characterized in that: A plurality of optical fibers are arranged in the shock waveguide tube, and the plurality of optical fibers form an optical fiber bundle. A lens is plated on the end of the optical fiber bundle as a whole. An annular metal target is sleeved on the periphery of the guide wire cavity, and a plurality of conical protrusions are arranged on the metal target. The driving mechanism can drive the optical fiber bundle to rotate along the periphery of the guide wire cavity, thereby making the lens correspond to the protrusions at different positions.

10. The high-strength calcified plaque fragmentation device according to claim 1 or 2, characterized in that: The tip of each optical fiber is provided with a hemispherical structure capable of focusing the emitted laser laterally, and the inner wall of the balloon is provided with a plurality of metal target protrusions.

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