Laser balloon catheter to inhibit vascular restenosis

Abstract

The present invention discloses a laser balloon catheter for inhibiting restenosis of a vascular lumen, comprising a catheter structure and a balloon. The catheter structure comprises a guidewire lumen located inside an outer tube, a low-power optical fiber bundle, and a trachea, wherein the low-power optical fiber bundle and the trachea are both located outside the guidewire lumen; the front end of the low-power optical fiber bundle and the front end of the guidewire lumen both extend out of the outer tube, and the front end side of the low-power optical fiber bundle is used to output a low-power laser; the balloon is sheathed on the front end of the catheter structure, forming a balloon air cavity between the balloon and the catheter structure, and the balloon air cavity is connected to the front end of the trachea so that gas is transported to the balloon air cavity through the trachea to inflate the balloon, thereby achieving expansion of the blood vessel; the balloon is made of a light-transmitting material so that the low-power laser output from the front end side of the low-power optical fiber bundle can pass through the balloon and irradiate the inner wall of the blood vessel. The present invention achieves the effect of inhibiting restenosis of the vascular lumen while expanding the narrowed part of the blood vessel.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, in particular to a laser balloon catheter for inhibiting restenosis of a blood vessel lumen. Background Art

[0002] The emergence of minimally invasive intravascular interventional therapy has provided a powerful treatment option for conditions such as intravascular thromboembolism and atherosclerosis. However, the problem of restenosis of the vascular lumen, which is prone to occur after surgery, is one of the major challenges currently faced. When using intravascular interventional devices for intravascular interventional therapy, the inner wall of the blood vessel will inevitably be damaged, subjected to friction and other stimuli, which can easily lead to cell proliferation on the inner wall of the blood vessel, causing the re-formation of thrombus, atherosclerotic plaques or stenosis of the blood vessel itself after surgery, which can easily lead to the recurrence of angina symptoms and the need for further surgery. Some patients may also develop acute coronary syndrome, re-form arteriovenous thrombosis in peripheral blood vessels, and re-initiate arteriosclerosis obliterans, etc., greatly reducing the expected clinical effect of the surgery and causing pain to the patient. Summary of the Invention

[0003] The present invention aims to solve at least one of the technical problems existing in the prior art. To this end, one object of the present invention is to provide a laser balloon catheter for inhibiting restenosis of the vascular lumen, which can dilate the stenotic part of the blood vessel while inhibiting restenosis of the vascular lumen.

[0004] The laser balloon catheter for inhibiting restenosis of a vascular lumen according to an embodiment of the present invention comprises:

[0005] A catheter structure comprising a guidewire cavity located inside an outer tube, a low-power optical fiber bundle, and an airway, wherein the low-power optical fiber bundle and the airway are both located outside the guidewire cavity; a front end of the low-power optical fiber bundle and a front end of the guidewire cavity both extend out of the outer tube, and a side surface of the front end of the low-power optical fiber bundle is used to output a low-power laser;

[0006] A balloon is sleeved on the front end of the catheter structure, forming a balloon air cavity between the balloon and the catheter structure, and the balloon air cavity is connected to the front end of the trachea so that gas can be transported to the balloon air cavity through the trachea to expand the balloon, thereby expanding the blood vessel; the balloon is made of a light-transmitting material so that the low-power laser output from the front end side of the low-power optical fiber bundle can pass through the balloon and irradiate the inner wall of the blood vessel.

[0007] The laser balloon catheter for inhibiting restenosis of the vascular lumen according to the embodiment of the present invention has the following advantages: first, the inner wall of the blood vessel is expanded by setting a transparent inflatable balloon, and the front end side of the low-power optical fiber bundle located in the balloon is set to output low-power laser to irradiate the inner wall of the blood vessel, thereby achieving the effect of better inhibiting restenosis in the vascular lumen while expanding the narrowed part of the blood vessel, greatly reducing the possibility of patients forming arteriovenous thrombosis again after surgery and inducing arteriosclerosis obliterans again, improving the expected clinical effect of the operation and reducing the patient's pain; second, the present invention can inject drugs into the blood vessel through the guidewire cavity to obtain a better effect of inhibiting restenosis of the blood vessel; third, the laser balloon catheter for inhibiting restenosis of the vascular lumen of the present invention has a simple structure and is easy to operate, is compatible with laser equipment, and is conducive to popularization.

[0008] According to some embodiments of the present invention, the balloon is made of a light-transmitting polymer material.

[0009] According to some embodiments of the present invention, the balloon is made of light-transmitting nylon material.

[0010] According to some embodiments of the present invention, the diameter of the balloon before expansion is 1.5-2 mm, and the maximum diameter after expansion is 3-4 mm.

[0011] According to some embodiments of the present invention, the laser balloon catheter for inhibiting restenosis of a vascular lumen further comprises an X-ray-proof metal ring, and the X-ray-proof metal ring is axially docked with the front end of the balloon.

[0012] According to some embodiments of the present invention, the X-ray opaque metal ring is a platinum ring.

[0013] According to some embodiments of the present invention, a reflector for reflecting low-power laser light is provided at the front end face of the low-power optical fiber bundle.

[0014] According to some embodiments of the present invention, the front end of the low-power optical fiber bundle is wrapped with a transparent film on the outside, and the transparent film separates the front end of the low-power optical fiber bundle from the balloon air cavity.

[0015] According to some embodiments of the present invention, the low-power optical fiber bundle is arranged in a single-layer ring shape outside the guidewire cavity.

[0016] According to some embodiments of the present invention, a connector is further included, which is connected to the rear end of the catheter structure. The connector has a guidewire interface, a pressure interface and a fiber optic bundle interface. The guidewire interface is connected to the rear end of the guidewire cavity, the pressure interface is connected between the rear end of the trachea and the air pump, and the fiber optic bundle interface is used for the low-power fiber optic bundle to pass through and connect to an external low-power laser.

[0017] Additional aspects and advantages of the present invention will be set forth in part in the description which follows and, in part, will be obvious from the description which follows, or may be learned by practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the following description of the embodiments with reference to the accompanying drawings, in which:

[0019] Figure 1 Schematic diagram of the structure of a laser balloon catheter for inhibiting restenosis of a vascular lumen according to an embodiment of the present invention.

[0020] Figure 2 2 is a cross-sectional view of the front end and balloon of the catheter structure according to an embodiment of the present invention.

[0021] Figure 3 It is a longitudinal cross-sectional view of the front end and balloon of the catheter structure according to an embodiment of the present invention.

[0022] Reference numerals:

[0023] Laser Balloon Catheter 1000 for Inhibiting Vascular Restenosis

[0024] Catheter structure 1

[0025] Guidewire cavity 101 Low-power optical fiber bundle 102 Reflector 1021 Transparent film 1022

[0026] Balloon 2 Balloon air cavity 3 Metal ring 4

[0027] Connector 5

[0028] Guidewire interface 501 Pressure interface 502 Fiber bundle interface 503

[0029] Guidewire A Air pump B DETAILED DESCRIPTION

[0030] The following describes embodiments of the present invention in detail. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended only to explain the present invention and are not to be construed as limiting the present invention.

[0031] The following combination Figures 1 to 3 The laser balloon catheter 1000 for inhibiting restenosis of a vascular lumen according to an embodiment of the present invention will be described.

[0032] like Figures 1 to 3As shown, the laser balloon catheter 1000 for inhibiting restenosis of the vascular cavity according to an embodiment of the present invention comprises a catheter structure 1 and a balloon 2. The catheter structure 1 comprises a guidewire cavity 101 located inside an outer tube, a low-power optical fiber bundle 102, and a trachea (not shown in the figure). The low-power optical fiber bundle 102 and the trachea are both located outside the guidewire cavity 101. The front end of the low-power optical fiber bundle 102 and the front end of the guidewire cavity 101 both extend out of the outer tube. The side surface of the front end of the low-power optical fiber bundle 102 is used to output low-power laser light. Figure 2 and Figure 3 As shown, the balloon 2 is sleeved on the front end of the catheter structure 1, and a balloon air cavity 3 is formed between the balloon 2 and the catheter structure 1. The balloon air cavity 3 is connected to the front end of the trachea, so that gas can be transported to the balloon air cavity 3 through the trachea to expand the balloon 2, thereby expanding the blood vessel; the balloon 2 is made of a light-transmitting material, so that the low-power laser output from the front end side of the low-power optical fiber bundle 102 can pass through the balloon 2 and irradiate the inner wall of the blood vessel.

[0033] Specifically, the catheter structure 1 includes a guidewire lumen 101 located inside an outer tube, a low-power fiber bundle 102, and a trachea. Both the low-power fiber bundle 102 and the trachea are located outside the guidewire lumen 101. It will be appreciated that the guidewire lumen 101, the low-power fiber bundle 102, and the trachea are all enclosed within the outer tube, which serves to protect and centrally secure the guidewire lumen 101, the low-power fiber bundle 102, and the trachea. The guidewire lumen 101 provides a passage for the guidewire A, allowing it to guide the catheter structure 1, allowing the tip of the catheter structure 1 to quickly, accurately, and conveniently reach the site of atrophied blood vessels. Furthermore, it serves as a channel for injecting drugs, such as paclitaxel, into the blood vessels, thereby improving the effectiveness of inhibiting restenosis within the vascular lumen. The low-power fiber bundle 102 transmits low-power laser light, allowing it to enter the blood vessels along the low-power fiber bundle 102 and directly illuminate the atrophied blood vessel walls. Preferably, the low-power laser is a low-power He-Ne laser with a wavelength of 632 nm or a low-power doubled frequency fiber laser with a wavelength of 515 nm.

[0034] The front end of the low-power optical fiber bundle 102 and the front end of the guidewire lumen 101 both extend out of the outer tube, and the side surface of the front end of the low-power optical fiber bundle 102 is used to output low-power laser light. It is understood that extending the front end of the low-power optical fiber bundle 102 out of the outer tube ensures that the low-power laser light output from the side surface of the front end is not blocked by the outer tube, effectively irradiating the inner wall of the blood vessel to inhibit intimal hyperplasia and prevent restenosis. The front end of the guidewire lumen 101 and the low-power optical fiber bundle 102 extend out of the outer tube together, making this structure more convenient to manufacture.

[0035] Optionally, the front side surface of the low-power optical fiber bundle 102 can be subjected to special treatment such as polishing to achieve light emission from the front side surface.

[0036] like Figure 2 and Figure 3 As shown, the balloon 2 is sheathed over the front end of the catheter structure 1, forming a balloon air chamber 3 between the balloon 2 and the catheter structure 1. The balloon air chamber 3 is in communication with the front end of the trachea, allowing gas to be delivered to the balloon air chamber 3 via the trachea to inflate the balloon 2, thereby dilating the blood vessel. It will be appreciated that the balloon 2 inherently has excellent expansion properties and the ability to recover from deformation, thereby enabling the balloon 2 in a deflated state to be delivered into or removed from a blood vessel, as well as enabling the inflated balloon 2 to dilate the blood vessel. Therefore, when dilating a region of atrophic blood vessels, the balloon 2 on the front end of the catheter structure 1 is first placed in an uninflated state or in a negative pressure state. The front end of the catheter structure 1 and the balloon 2 are then brought to the region of atrophic blood vessels. Then, gas is delivered to the balloon air chamber 3 via the trachea to inflate the balloon air chamber 3, thereby dilating the atrophic blood vessels.

[0037] The balloon 2 is made of a light-transmitting material so that the low-power laser light outputted from the front end side of the low-power optical fiber bundle 102 can pass through the balloon 2 and irradiate the inner wall of the blood vessel (such as Figure 3 That is, while the inflated balloon cavity 3 dilates the atrophied blood vessel, the front end side of the low-power optical fiber bundle 102 can also output a low-power laser. The low-power laser transmitted through the balloon 2 irradiates the inner wall of the blood vessel, inducing apoptosis of smooth muscle cells in the blood vessel, thereby inhibiting intimal hyperplasia and achieving the effect of preventing restenosis in the blood vessel cavity. This greatly reduces the possibility of patients developing arteriovenous thrombosis again after surgery, re-inducing arteriosclerosis obliterans, etc., thereby improving the expected clinical effect of the surgery and reducing the patient's pain.

[0038] The following describes the specific use process of the laser balloon catheter 1000 for inhibiting restenosis of the vascular lumen according to an embodiment of the present invention. First, before the operation, the vascular lesion condition is evaluated by angiography, and the laser balloon catheter 1000 for inhibiting restenosis of the vascular lumen according to the embodiment of the present invention and the catheter sheath of the appropriate size are selected. The front end of the guidewire A is lubricated and inserted into the guidewire cavity 101 of the catheter structure 1 until it extends from the front end of the guidewire cavity 101. The low-power optical fiber bundle 102 and the trachea are respectively connected to the external low-power laser and the external air pump B; then, a suitable site is selected for puncturing the blood vessel, and the catheter sheath is placed at the puncture site. The guidewire A passes through the catheter sheath into the blood vessel and moves along the blood vessel until the front end of the guidewire A passes through the atrophy of the vascular lesion; then, the laser balloon catheter 1000 for inhibiting restenosis of the vascular lumen according to the embodiment of the present invention is moved along the guidewire A until the balloon 2 reaches the blood vessel. The lesion is atrophied, and then the trachea is used to deliver gas to the balloon 2 to expand the balloon 2, so that the external low-power laser delivers low-power laser to the low-power optical fiber bundle 102, and the low-power laser is output from the front end side of the low-power optical fiber bundle 102 to irradiate the inner wall of the blood vessel at the atrophy of the vascular lesion for 30-60 seconds; finally, the air pump B is adjusted to negative pressure, and the gas in the balloon air cavity 3 will be drawn out to make the balloon 2 completely shrink, and then the low-power laser continues to irradiate the blood vessel wall, and an appropriate amount of paclitaxel and other drugs that can inhibit vascular wall hyperplasia and restenosis are injected into the guide wire A cavity. After 60 seconds, the external low-power laser is turned off, and the laser balloon catheter 1000 for inhibiting vascular lumen restenosis and the guide wire A of the embodiment of the present invention are withdrawn in turn. The operation is simple and the effect of inhibiting vascular lumen restenosis is good.

[0039] The laser balloon catheter 1000 for inhibiting restenosis of the vascular cavity according to the embodiment of the present invention has the following advantages. First, the inner wall of the blood vessel is expanded by providing a transparent inflatable balloon 2, and the front end side of the low-power optical fiber bundle 102 located in the balloon 2 is provided to output low-power laser to irradiate the inner wall of the blood vessel, thereby achieving the effect of better inhibiting restenosis in the vascular cavity while expanding the narrowed part of the blood vessel, greatly reducing the possibility of patients forming arteriovenous thrombosis again after surgery and inducing arteriosclerosis obliterans again, improving the expected clinical effect of the operation and reducing the pain of patients; second, the present invention can inject drugs into the blood vessel through the guidewire cavity 101 to obtain a better effect of inhibiting restenosis of the blood vessel; third, the laser balloon catheter structure 1000 for inhibiting restenosis of the vascular cavity of the present invention is simple and easy to operate, and is compatible with laser equipment, which is conducive to promotion and popularization.

[0040] According to some embodiments of the present invention, the balloon 2 is made of a light-transmitting polymer material. The use of the light-transmitting polymer material to make the balloon 2, on the one hand, makes the balloon 2 have good deformation ability, so that the uninflated balloon 2 can be easily delivered into or taken out of the blood vessel cavity, and at the same time, it will deform after inflation to expand the inner wall of the blood vessel cavity well; on the other hand, the polymer material is low in cost, stable, has good toughness, is not easy to be damaged, and can avoid rejection reactions to a certain extent.

[0041] According to some embodiments of the present invention, balloon 2 is made of a translucent nylon material. Using translucent nylon to make balloon 2 provides excellent deformability, allowing for easy insertion and removal of the uninflated balloon 2 into and from the vascular lumen. Furthermore, after inflation, the balloon 2 deforms to effectively expand the vascular lumen. Furthermore, translucent nylon is low-cost, stable, and tough, making it difficult to damage and, to a certain extent, preventing rejection.

[0042] According to some embodiments of the present invention, the diameter of the balloon 2 before expansion is 1.5-2 mm, and the maximum diameter after expansion is 3-4 mm. It is understood that the 1.5-2 mm diameter of the balloon 2 before expansion facilitates insertion of the unexpanded balloon 2 into the blood vessel lumen; the 3-4 mm maximum diameter of the balloon 2 after expansion effectively supports and dilates the blood vessel, is less likely to damage the vessel, and is less likely to shift the position of the balloon 2.

[0043] According to some embodiments of the present invention, Figure 3 As shown, the laser balloon catheter 1000 for inhibiting vascular restenosis further includes an X-ray opaque metal ring 4, which is axially connected to the front end of the balloon 2. It should be noted that the X-ray opaque metal ring 4 is provided to determine the position of the front end of the balloon 2 during angiography of the blood vessel, thereby visually determining whether the balloon 2 has reached the lesion.

[0044] According to some embodiments of the present invention, the radiopaque metal ring 4 is a platinum ring. The platinum ring is used to determine the position of the leading end of the balloon 2 during vascular angiography, thereby determining whether the balloon 2 has reached the lesion. Furthermore, platinum metal has excellent biocompatibility, preventing vascular allergies or rejection of the metal. Alternatively, the radiopaque metal ring 4 can be a titanium ring, which also exhibits excellent biocompatibility.

[0045] According to some embodiments of the present invention, Figure 3 As shown, a reflector 1021 for reflecting low-power laser light is provided at the front end face of the low-power optical fiber bundle 102 to improve the uniformity of the low-power laser light, reduce the loss of the low-power laser light, and improve the radiation efficiency.

[0046] According to some embodiments of the present invention, Figure 2 As shown, the front end of the low-power optical fiber bundle 102 is wrapped with a transparent film 1022, which separates the front end of the low-power optical fiber bundle 102 from the balloon air cavity 3. It can be understood that the use of the transparent film 1022 to separate the front end of the low-power optical fiber bundle 102 from the balloon air cavity 3 can ensure the airtightness of the balloon air cavity 3 to a certain extent. At the same time, the transparent film 1022 can fix the front end of the low-power optical fiber bundle 102, making the processing of the laser balloon catheter 1000 for inhibiting vascular restenosis according to the embodiment of the present invention simpler and more convenient.

[0047] According to some embodiments of the present invention, Figure 2 As shown, the low-power optical fiber bundle 102 is arranged in a single-layer ring outside the guidewire cavity 101. The ring-shaped arrangement of the low-power optical fiber bundle 102 allows the low-frequency laser to be evenly irradiated on the inner wall of the blood vessel in a circumferential direction, effectively inhibiting restenosis of the inner wall of the blood vessel cavity. In addition, the low-power optical fiber bundle 102 can also be arranged in multiple layers, but the structure of a single-layer optical fiber bundle is simpler and the emission efficiency of the low-power laser is also higher.

[0048] According to some embodiments of the present invention, Figure 1 As shown, the laser balloon catheter 1000 for inhibiting vascular restenosis further includes a connector 5, which is connected to the rear end of the catheter structure 1. The connector 5 has a guidewire interface 501, a pressure interface 502, and an optical fiber bundle interface 503. The guidewire interface 501 is connected to the rear end of the guidewire cavity 101, so that a guidewire A can be delivered from the guidewire interface 501 to the guidewire cavity 101, facilitating operation. The pressure interface 502 is connected between the rear end of the trachea and the air pump B. In other words, the pressure interface 502 is used to connect the rear end of the trachea and the air pump B, so that the air pump B is connected to the trachea. In this way, the pressure in the balloon cavity 3 can be controlled by adjusting the air pump B. For example, the balloon cavity 3 can be inflated by the air pump B to expand the balloon 2 to dilate the stenotic lesion. By adjusting the air pump B to a negative pressure, the balloon 2 is completely deflated, so that the balloon 2 can be easily delivered into or removed from the blood vessel. The fiber bundle interface 503 is used for the low-power fiber bundle 102 to pass through to connect to an external low-power laser. It can be understood that the low-power fiber bundle 102 can be fixed on the fiber bundle interface 503 to prevent the low-power fiber bundle 102 from unnecessary movement; or the fiber bundle interface 503 is only used to provide an opening for the low-power fiber bundle 102 to pass through the connector 5 to facilitate operation of the low-power fiber bundle 102.

[0049] According to some embodiments of the present invention, low-power fiber bundle 102 is a single-mode fiber or a multimode fiber, and the diameter of a single fiber in low-power fiber bundle 102 is 50-75 μm. Preferably, low-power fiber bundle 102 is a single-mode fiber. The use of single-mode fiber can reduce the loss of low-power laser light during transmission and improve transmission efficiency. At the same time, the smaller diameter of single-mode fiber can be easily combined into a smaller diameter low-power fiber bundle 102 for placement into a blood vessel. The diameter of a single fiber in low-power fiber bundle 102 is 50-75 μm, which facilitates coupling operations and has strong practical applicability.

[0050] Throughout this specification, references to terms such as "one embodiment," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples" indicate that the specific features, structures, or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

[0051] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to the embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the claims and their equivalents.

Claims

1. A laser balloon catheter for inhibiting restenosis of a vascular lumen, characterized in that: include: A catheter structure comprising a guidewire cavity located inside an outer tube, a low-power optical fiber bundle, and a trachea, wherein the low-power optical fiber bundle and the trachea are both located outside the guidewire cavity; a front end of the low-power optical fiber bundle and a front end of the guidewire cavity both extend out of the outer tube; a reflector for reflecting low-power laser light is provided at the front end face of the low-power optical fiber bundle; a side surface of the front end of the low-power optical fiber bundle is used to output low-power laser light; the guidewire cavity is used to provide a channel for the guidewire to pass through, and the guidewire cavity also serves as a channel for injecting drugs into the blood vessel; A balloon is sheathed over the front end of the catheter structure, forming a balloon air cavity between the balloon and the catheter structure, the balloon air cavity being in communication with the front end of the trachea so that gas is delivered to the balloon air cavity through the trachea to inflate the balloon, thereby dilating the blood vessel; the balloon is made of a light-transmitting material so that the low-power laser output from the front side of the low-power optical fiber bundle can pass through the balloon and irradiate the inner wall of the blood vessel; The front end of the low-power optical fiber bundle is wrapped with a transparent film on the outside, and the transparent film separates the front end of the low-power optical fiber bundle from the balloon air cavity.

2. The laser balloon catheter for inhibiting vascular restenosis according to claim 1, characterized in that: The balloon is made of light-transmitting polymer material.

3. The laser balloon catheter for inhibiting vascular restenosis according to claim 2, characterized in that: The balloon is made of light-transmitting nylon material.

4. The laser balloon catheter for inhibiting vascular restenosis according to claim 2, characterized in that: The diameter of the balloon before expansion is 1.5-2 mm, and the maximum diameter after expansion is 3-4 mm.

5. The laser balloon catheter for inhibiting vascular restenosis according to claim 1, characterized in that: It also includes an X-ray-proof metal ring, which is axially connected to the front end of the balloon.

6. The laser balloon catheter for inhibiting vascular restenosis according to claim 5, characterized in that: The X-ray-proof metal ring is a platinum ring.

7. The laser balloon catheter for inhibiting vascular restenosis according to any one of claims 1 to 6, characterized in that: The low-power optical fiber bundle is arranged in a single-layer ring shape outside the guidewire cavity.

8. The laser balloon catheter for inhibiting vascular restenosis according to any one of claims 1 to 6, characterized in that: It also includes a connector, which is connected to the rear end of the catheter structure. The connector has a guidewire interface, a pressure interface and an optical fiber bundle interface. The guidewire interface is connected to the rear end of the guidewire cavity, the pressure interface is connected between the rear end of the trachea and the air pump, and the optical fiber bundle interface is used for the low-power optical fiber bundle to pass through and connect to an external low-power laser.

Images