Laser treatment equipment used in blood vessel cavity

Abstract

The invention relates to the field of medical instruments, in particular to a laser treatment device used in a blood vessel cavity, which comprises a flexible waveguide tube with a near end connected with a laser light source and a far end suitable for being placed in a blood vessel; the far end of the waveguide tube is provided with at least one radiation emission structure and a cover piece, the cover piece wraps and is fixedly connected to the far end of the waveguide tube, the inner surface of the cover piece is provided with a light absorption structure, the light absorption structure is axially opposite to the radiation emission structure, and the radiation emission structure is arranged on the inner surface of the cover piece. The radiation is axially propagated along the long axis direction of the waveguide tube and arrives at the long axis direction of the waveguide tube; moreover, a gap between the far end of the waveguide tube and the inner cavity of the cover piece is filled with a curable fluid material, so that a solid-solid optical interface is formed; the solid-solid optical interface is arranged between the radiation emission structure and the cover piece, so that light refraction and deviation from a preset emission path can be effectively avoided.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically to a laser therapy device for use in blood vessels. Background Technology

[0002] The human lower limb venous system is primarily composed of a superficial venous system and a deep venous system, both connected by perforating veins. The superficial venous system includes the large and small saphenous veins, while the deep venous system includes the anterior tibial vein and the posterior tibial vein, which converge to form the popliteal vein near the knee. The popliteal vein then becomes the femoral vein where it joins the small saphenous vein.

[0003] The venous system includes valves that allow unidirectional blood flow back to the heart. The venous valves are the mitral valves, with each cusp forming a blood reservoir. The mitral venous valves push their free surfaces together under retrograde blood pressure. When functioning properly, this prevents retrograde blood flow, allowing only antegrade flow towards the heart. The mitral valves become ineffective when their cusps fail to seal properly under a retrograde pressure gradient. When retrograde blood flow occurs, the pressure in the inferior venous portion increases, which can dilate the vein and cause additional valve failure.

[0004] Valve failure, commonly known as venous insufficiency, is a chronic condition that can cause skin discoloration, varicose veins, pain, swelling, and ulceration. Varicose veins are blood vessels that have become dilated and tortuous, and whose walls gradually lose elasticity. Due to the widening of the vessels, the valves cannot close completely, and the veins lose their ability to carry blood back to the heart. This leads to blood pooling within the vessels, which further dilates and tortuouss the veins. Varicose veins are typically bluish or purplish and can protrude from the skin's surface in a tortuous form, causing a distinctive and unsightly appearance. Varicose veins generally form in the superficial veins of the legs, which are subjected to high pressure when standing. Other types of varicose veins include venous lakes, reticular veins, and capillary dilatations.

[0005] Another minimally invasive treatment for varicose veins in the prior art is endovascular laser ablation (“ELA”). In a typical prior art ELA procedure, an optical fiber is introduced into the vein to be treated via an insertion sheath. The optical fiber has a flat emitting surface at its distal end. An exemplary prior art ELA procedure includes the following steps: First, preferably by means of an insertion needle, a guide wire is inserted into the vein to be treated. Second, the insertion sheath is introduced and advanced via the guide wire to the treatment site. Then, the guide wire is removed, leaving the insertion sheath in place. Subsequently, the optical fiber (coupled to a laser source) is inserted through the insertion sheath and positioned such that the flat emitting surface at the distal end of the fiber and the sheath are at the same point. Subsequently, tumescent anesthesia is applied to the tissue surrounding the vein to be treated. Before laser emission, the sheath is pulled back a distance from the flat emitting surface, sufficient to prevent the emitted laser energy from damaging the sheath. The laser is then emitted to deliver laser energy through the flat emitting surface and allow it to directly enter the blood and / or vein wall in front of the emitting surface. As the laser energy is emitted, the laser fiber and the insertion sheath are withdrawn together to treat and close the vein to the desired length. Laser energy is absorbed by blood and / or vein wall tissue, which in turn thermally damages the veins and causes fibrosis.

[0006] For example, patent application CN200980107138.9 discloses a device for endovascular treatment of blood vessels, comprising: a flexible waveguide defining an elongated axis, a proximal end optically connectable to a laser source, a distal end receptacle within a blood vessel and including a radiation-emitting surface, and a cover, the radiation-emitting surface emitting radiation from the laser source laterally relative to the elongated axis of the waveguide onto an angular extension of the peripheral blood vessel wall, the cover being fixedly fastened to the waveguide and sealing the waveguide, the cover encapsulating the emitting surface within it and defining a gas-waveguide interface that laterally refracts the emitted radiation relative to the elongated axis of the waveguide onto the surrounding blood vessel wall. In this patented solution, there is a gas-waveguide interface between the cover and the radiating surface. When the laser passes through different media, it will inevitably be refracted, causing the light to deviate at an angle. The optical fiber cannot accurately illuminate the target position as expected. Furthermore, the coaxiality requirement is extremely high when the cover is assembled with the optical fiber head end; otherwise, the light emission path will also be deviated.

[0007] In summary, while the cover in the existing technology can prevent the sharp tip of the optical fiber from puncturing blood vessels, there are other problems such as the gas-waveguide interface between the cover and the transmitting surface causing the light path to deviate, and the extremely high requirement for coaxiality during assembly, which is not conducive to mass production. Summary of the Invention

[0008] This application is made in view of the above and other ideas.

[0009] One of the purposes of this application is to overcome the shortcomings of the prior art, such as the existence of a gas-waveguide interface between the cover and the emitting surface causing the light path to deviate, and the extremely high requirements for coaxiality during assembly, which are not conducive to mass production, and to provide a laser treatment device for intravascular cavity.

[0010] The technical solution adopted to solve the technical problem of the present invention is to provide a laser treatment device for intravascular cavity, including a flexible waveguide, the proximal end of which is used to connect a laser source and the distal end is adapted to be inserted into a blood vessel; the distal end of the waveguide is provided with at least one radiation emitting structure and a cover, the cover covering and fixed to the distal end of the waveguide, the inner surface of the cover being provided with a light absorption structure, the light absorption structure being axially opposite to the radiation emitting structure and being used to absorb radiation that propagates axially along the long axis of the waveguide and reaches there; and the gap between the distal end of the waveguide and the inner cavity of the cover is filled with a solidified fluid material to form a solid-solid optical interface.

[0011] As a further improvement of the present invention, the curable fluid material is a UV-curable adhesive, epoxy resin, or silicone rubber. As a further improvement of the present invention, the light absorption structure is disposed on the top of the inner surface of the cover; the light absorption structure includes a central conical portion and two side conical portions symmetrically distributed on both sides thereof; the central conical portion corresponds axially to the tip of the radiation emitting surface at the distal end of the waveguide; the side conical portions are spaced apart from the central conical portion by a predetermined distance, thereby forming a channel between them.

[0012] As a further improvement of the present invention, the radiation emission structure includes at least two radiation emission surfaces, and the two radiation emission surfaces form an angle of 60° to 80° between them, so that the distal end of the waveguide presents a symmetrical conical structure.

[0013] As a further improvement of the invention, the channel formed by the interval between the side cone portion and the central cone portion is configured to first refract radiation arriving there laterally.

[0014] As a further improvement of the present invention, the outer surface of the channel is coated with black medical epoxy resin / adhesive.

[0015] As a further improvement of the present invention, during assembly, a curing fluid material is first injected into the inner cavity of the cover, and then the distal end of the waveguide is inserted into the inner cavity of the cover. Some of the curing fluid material in the inner cavity of the cover will overflow. Wipe away the overflowing curing fluid material, let it stand for a moment, and wait for the curing fluid material in the inner cavity of the cover to be fixed, so that the distal end of the waveguide and the inner cavity of the cover form a solid-solid optical interface.

[0016] As a further improvement of the invention, the laser source provides laser radiation of at least one wavelength between about 1470 nm and about 1950 nm, each ± ​​about 30 nm, at a power of less than or equal to about 10 W, wherein the proximal end of the waveguide is optically coupled to the at least one laser source, and wherein the radiation emission structure of the waveguide emits radiation laterally onto the peripheral blood vessel wall in an axially extending annular pattern relative to the elongated axis of the waveguide.

[0017] As a further improvement of the present invention, the distal end of the cover is shaped into a spherical, smooth surface to avoid causing mechanical damage to the inner wall of the blood vessel when it enters the blood vessel.

[0018] As another embodiment of the present invention, a flexible waveguide is included, the proximal end of which is used to connect to a laser light source and the distal end is adapted to be inserted into a blood vessel; the distal end of the waveguide is provided with at least one radiation emission structure and a cover, the cover covering and fixed to the distal end of the waveguide, the inner surface morphology of the cover matching the outer surface morphology of the radiation emission structure, so that the distal end of the waveguide and the cover form a solid-solid optical interface.

[0019] As a further improvement of the present invention, an optical coupling medium is filled between the distal end of the waveguide and the inner cavity of the cover, so that the radiation emitted from the radiation emission structure is directly coupled to the cover via the solid-solid optical interface and emitted laterally about the long axis of the waveguide.

[0020] As a further improvement of the present invention, the distal end of the cover is provided with a spherical guide head, which is used to smoothly push aside tissue when traveling in blood vessels to avoid puncture.

[0021] As a further improvement of the present invention, a light absorption point is provided at the far end inside the cover, and the position of the light absorption point corresponds axially to the tip of the radiation emitting surface at the far end of the waveguide, and is used to absorb the laser light emitted axially from the waveguide.

[0022] In the prior art, the gas-waveguide interface between the cover and the emitting surface causes the light path to deviate. According to a concept of this application, a solidified fluid material is injected between the distal end of the waveguide and the inner cavity of the cover. On the one hand, this can form a solid-solid optical interface between the cover and the distal end of the waveguide (i.e., the radiation emission structure). This allows the laser light path to pass through the distal end of the waveguide - the solidified fluid layer - the cover - and then be emitted to the target treatment position. The laser light path always propagates within the solid optical interface and will not be deviated in angle due to passing through different media. On the other hand, injecting a solidified fluid material into the inner cavity of the cover not only unifies the propagation medium but also facilitates production and processing, making it highly practical.

[0023] According to a concept of this application, the radiation-emitting structure is symmetrically conical. When light passes through the radiation-emitting structure, it is refracted and emitted in a circumferential direction to form a light ring, which corresponds to a specific area in the blood vessel that needs treatment. However, in actual manufacturing, the tip of the radiation-emitting structure has a flat surface, causing some laser light to be emitted axially along the tip, damaging the blood vessel. Therefore, a light-absorbing structure needs to be set inside the cover to absorb the axially emitted laser light. The light-absorbing structure includes a central conical part and two symmetrically distributed side conical parts on both sides. There is a reserved gap between the side conical parts and the central conical part to form a channel. The axially emitted light enters the channel and undergoes multiple refractions within the channel. The channel is coated with a light-absorbing material, and the light is completely absorbed after multiple refractions, effectively avoiding the problem of axial light damaging the blood vessel.

[0024] According to one concept of this application, the distal end of the cover is a spherical smooth surface or the distal end of the cover is provided with a spherical guide head, which prevents the waveguide from causing mechanical damage to the blood vessel when it is pushed into the blood vessel.

[0025] The embodiments of this application can achieve other advantageous technical effects not listed one by one. These other technical effects may be partially described below and can be expected and understood by those skilled in the art after reading this application. Attached Figure Description

[0026] The above-described features and advantages, as well as other features and advantages, and the ways in which they are implemented, of these embodiments will become more apparent and the embodiments of this application will be better understood by referring to the following description in conjunction with the accompanying drawings, in which: Figure 1 and Figure 2 This is a schematic diagram of the structure of Embodiment 1 of the present invention.

[0027] Figure 3 This is a schematic diagram of the structure of Embodiment 2 of the present invention.

[0028] The features represented by the numbers in the attached diagram are as follows: Waveguide, 11-Radiation emission structure, 111-Radiation emission surface, 2-Cover, 21-Light absorption structure, 211-Central cone, 212-Side cone, 213-Channel, 22-Spherical smooth surface, 23-Light absorption point, 3-Cease fluid material, 4-Solid-solid optical interface, 5-Optical coupling medium, 6-Guide head. Detailed Implementation

[0029] The details of one or more embodiments of this application will be set forth in the following description of the accompanying drawings and specific embodiments. Other features, objects, and advantages of this application will become clear from these descriptions, drawings, and claims.

[0030] It should be understood that the illustrated and described embodiments are not limited in application to the details of the construction and arrangement of the components set forth in the following description or illustrated in the accompanying drawings. The illustrated embodiments may be other embodiments and can be implemented or performed in various ways. The examples are provided by way of explanation rather than limitation of the disclosed embodiments. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the embodiments of this application without departing from the scope or spirit of this disclosure. For example, features illustrated or described as part of one embodiment may be used with another embodiment to still produce another embodiment. Therefore, this disclosure covers such modifications and variations that fall within the scope of the appended claims and their equivalents.

[0031] Similarly, it is understood that the phrases and terms used in this document are for descriptive purposes and should not be considered restrictive. The use of “including,” “contains,” or “has,” and their variations, in this document is intended to include, in an open-ended manner, the items listed thereafter, their equivalents, and any additional items.

[0032] The present application will now be described in more detail with reference to various embodiments and examples of several aspects thereof.

[0033] One of the objectives of the embodiments described below is to address the aforementioned deficiencies, as well as other problems.

[0034] Example 1: In this example, the laser treatment device is used to treat varicose veins. A laser treatment device for use within blood vessels, such as... Figure 1As shown, the device includes a flexible waveguide 1, with its proximal end for connecting to a laser source and its distal end suitable for insertion into a blood vessel. The distal end of the waveguide 1 has at least one radiation-emitting structure 11 and a cover 2, which covers and is fixed to the distal end of the waveguide 1. The inner surface of the cover 2 has a light-absorbing structure 21, which is axially opposite to the radiation-emitting structure 11 and is used to absorb radiation propagating axially along the long axis of the waveguide 1 and reaching that location. Furthermore, the gap between the distal end of the waveguide 1 and the inner cavity of the cover 2 is filled with a solidifying fluid material 3 to form a solid-solid optical interface 4. During assembly, the solidifying fluid material 3 is first injected into the inner cavity of the cover 2, and then the distal end of the waveguide 1 is inserted into the inner cavity of the cover 2. Some of the solidifying fluid material 3 in the inner cavity of the cover 2 will overflow. The overflowing solidifying fluid material 3 is wiped away, and the device is left to stand for a moment until the solidifying fluid material 3 in the inner cavity of the cover 2 is fixed, thus forming a solid-solid optical interface 4 between the distal end of the waveguide 1 and the inner cavity of the cover 2.

[0035] In this embodiment, the curable fluid material 3 is a UV-curable adhesive, epoxy resin, or silicone rubber.

[0036] In this embodiment, as Figure 2 As shown, the light absorption structure 21 is disposed on the top of the inner surface of the cover 2; the light absorption structure 21 includes a central conical portion 211 and two side conical portions 212 symmetrically distributed on both sides thereon; the central conical portion 211 corresponds axially to the tip of the radiation emitting surface 111 at the distal end of the waveguide 1; the tips of the side conical portions 212 are spaced apart from the tips of the central conical portion 211 by a predetermined distance, thereby forming a channel 213 between them.

[0037] In this embodiment, the waveguide 1 is made of a single optical fiber component, and the cover 2 is made of silicon dioxide material.

[0038] In this embodiment, the radiation emission structure 11 includes at least two radiation emission surfaces 111, and the two radiation emission surfaces 111 form an angle of 60° to 80°, so that the distal end of the waveguide 1 presents a symmetrical conical structure.

[0039] In this embodiment, the channel 213 formed by the interval between the side cone portion 212 and the central cone portion 211 is configured to first refract the radiation arriving there laterally.

[0040] In this embodiment, the outer surface of the channel 213 is coated with black medical epoxy resin / adhesive.

[0041] In this embodiment, the laser source provides laser radiation at least one wavelength of about 1470 nm and about 1950 nm, each ± ​​about 30 nm, with a power of less than or equal to about 10 W, wherein the proximal end of the waveguide is optically coupled to the at least one laser source, and wherein the radiation emitting structure 11 of the waveguide emits radiation laterally onto the peripheral blood vessel wall in an axially extending annular pattern relative to the elongated axis of the waveguide. Example

[0042] Example 2 is largely the same as Example 1, except that the inner cavity shape of the cover 2 is designed to match the distal shape of the waveguide 1.

[0043] like Figure 3 The illustration shows a laser therapy device for intravascular cavity, including a flexible waveguide 1, the proximal end of which is used to connect to a laser source, and the distal end which is adapted to be inserted into a blood vessel; the distal end of the waveguide 1 is provided with at least one radiation emitting structure 11 and a cover 2, the cover 2 covering and fixed to the distal end of the waveguide 1, the inner surface morphology of the cover 2 matching the outer surface morphology of the radiation emitting structure 11, so that the distal end of the waveguide 1 and the cover 2 form a solid-solid optical interface 4.

[0044] In this embodiment, an optical coupling medium 5 is filled between the distal end of the waveguide 1 and the inner cavity of the cover 2, so that the radiation emitted from the radiation emission structure 11 is directly coupled to the cover 2 via the solid-solid optical interface 4 and emitted laterally about the long axis of the waveguide 1.

[0045] In this embodiment, the optical coupling medium 5 is an optical gel material.

[0046] In this embodiment, the distal end of the cover 2 is provided with a spherical guide head 6, which is used to smoothly push aside tissue when traveling in blood vessels to avoid puncture.

[0047] In this embodiment, a light absorption point 23 is provided at the far end inside the cover 2. The position of the light absorption point 23 corresponds to the tip axis of the radiation emitting surface 111 at the far end of the waveguide 1, and is used to absorb the laser light emitted axially from the waveguide 1.

[0048] In this regard, the relevant construction and concept of Embodiment 2 are similar to those of Embodiment 1, and therefore will not be described again here.

[0049] The foregoing description of the embodiments described above is provided for illustrative purposes. This foregoing description is not intended to be exhaustive, nor is it intended to limit the application to the precise configurations, constructions, and / or steps disclosed. Clearly, many modifications and variations can be made in light of the teachings above. The scope of the invention and all its equivalents are intended to be defined by the appended claims.

Claims

1. A laser therapy device for intravascular cavity, comprising a flexible waveguide, the proximal end of which is connected to a laser source, and the distal end of which is adapted for insertion into a blood vessel; the distal end of the waveguide is provided with at least one radiation-emitting structure, characterized in that: A cover is provided, which covers and is fixed to the distal end of the waveguide. The inner surface of the cover is provided with a light-absorbing structure, which is axially opposite to the radiation-emitting structure and is used to absorb radiation that propagates axially along the long axis of the waveguide and reaches there. Furthermore, the gap between the distal end of the waveguide and the inner cavity of the cover is filled with a solidified fluid material to form a solid-solid optical interface.

2. The laser therapy device for intravascular cavity according to claim 1, characterized in that: The light-absorbing structure is disposed on the top of the inner surface of the cover; the light-absorbing structure includes a central conical part and two side conical parts symmetrically distributed on both sides thereon; the central conical part corresponds axially to the tip of the radiation emitting surface at the distal end of the waveguide; the side conical parts are spaced apart by a predetermined distance from the central conical part, thereby forming a channel between them.

3. The laser therapy device for intravascular cavity according to claim 2, characterized in that: The channel formed by the gap between the side cone and the central cone is configured to first refract radiation arriving there laterally.

4. A laser therapy device for intravascular cavity according to claim 3, characterized in that: The outer surface of the channel is coated with black medical epoxy resin / adhesive.

5. A laser therapy device for intravascular cavity according to claim 1, characterized in that: The laser source provides laser radiation at least one wavelength of about 1470 nm and about 1950 nm, each ± ​​about 30 nm, with a power of less than or equal to about 10 W, wherein the proximal end of the waveguide is optically coupled to the at least one laser source, and wherein the radiation emission structure of the waveguide emits radiation laterally onto the peripheral blood vessel wall in an axially extending annular pattern relative to the elongated axis of the waveguide.

6. A laser therapy device for intravascular cavity according to claim 1, characterized in that: The radiation emission structure includes at least two radiation emission surfaces, with an angle of 60° to 80° between the two radiation emission surfaces, so that the distal end of the waveguide presents a symmetrical conical structure.

7. A laser therapy device for intravascular cavity according to claim 1, characterized in that: The distal end of the cap is shaped into a smooth spherical surface to avoid mechanical damage to the inner wall of the blood vessel when it enters the blood vessel.

8. A laser therapy device for intravascular cavity, comprising a flexible waveguide, the proximal end of which is connected to a laser source, and the distal end of which is adapted for insertion into a blood vessel; the distal end of the waveguide is provided with at least one radiation-emitting structure, characterized in that: A cover is provided, which covers and is fixed to the distal end of the waveguide. The inner surface morphology of the cover matches the outer surface morphology of the radiation emission structure, so that the distal end of the waveguide and the cover form a solid-solid optical interface.

9. A laser therapy device for intravascular cavity according to claim 8, characterized in that: The distal end of the waveguide is filled with an optical coupling medium between itself and the inner cavity of the cover, such that radiation emitted from the radiation-emitting structure is directly coupled to the cover via the solid-solid optical interface and emitted laterally about the long axis of the waveguide.

10. A laser therapy device for intravascular cavity according to claim 9, characterized in that: The distal end of the cap is provided with a spherical guide head, which is used to smoothly push aside tissue when traveling within the blood vessel to avoid puncture.

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