Catheter system for transarterial chemoembolization and photodynamic therapy

Abstract

The invention provides a catheter system for transarterial chemoembolism and photodynamic therapy, which comprises a catheter main body capable of being inserted into an artery, namely an inner tube and an outer tube annularly arranged outside the inner tube, a cavity for storing and conveying medicine is formed in the inner tube, an optical fiber connected with the laser light source is arranged between the inner tube and the outer tube, and laser transmitted by the optical fiber can be output through the front end between the inner tube and the outer tube. The inner tube is used for releasing chemical drugs, embolism materials and photosensitizers, laser output by the optical fiber between the inner tube and the outer tube is used for activating the photosensitizers in tumor tissue, and TACE and PDT are achieved at the same time. PDT is applied to clinical treatment of liver cancer for the first time, the PDT and TACE are combined in a catheter system, TACE and PDT can be conducted at the same time through one-time intubation, the innovative composite interventional therapy technology is combined with minimally invasive interventional medicine and photodynamic therapy technologies, the feasibility of treatment of deep liver tumors is improved, the intubation frequency of a patient is reduced, and the treatment cost is reduced. And the treatment process is simplified.

Description

Technical Field

[0001] The invention belongs to the technical field of medical devices, and in particular relates to a catheter system for trans-arterial chemoembolization and photodynamic therapy. Background Art

[0002] Transarterial chemoembolization (TACE) and photodynamic therapy (PDT) are two effective local treatments for tumors.

[0003] TACE directly kills tumor cells and interrupts blood supply by delivering chemotherapy drugs and embolic materials directly to the tumor blood supply artery, such as the microcatheter for transcatheter arterial chemoembolization (TACE) disclosed in CN201710103523.2, or a catheter for hepatic artery perfusion chemotherapy disclosed in CN202321780835.4, or an inferior epigastric artery chemotherapy catheter disclosed in CN201120315174.9. However, due to the blood supply characteristics of the tumor and the uneven distribution of chemotherapy drugs, some areas may not be able to obtain sufficient drug concentrations, resulting in uneven treatment effects, often leading to treatment failure or recurrence.

[0004] PDT is a technology that uses the photodynamic effect to diagnose and treat diseases. First, photosensitive substances are used to mark target tissue cells, and then lasers of a specific wavelength are used to activate the photosensitizer to generate reactive oxygen species (ROS). Excessive ROS can cause oxidative damage to the mitochondria and DNA of cancer cells, thereby killing cancer cells. For example, CN202120619251.3 discloses a light guide rod and photodynamic therapy device for photodynamic therapy, or CN202322170145.3 discloses a therapeutic device for photodynamic therapy. The aggregation and activation of photosensitizers in tumor tissues are the key to PDT, which mainly uses ultraviolet light or visible light as an excitation light source. However, photons within this wavelength range are easily absorbed or quenched by biological tissues, resulting in a low tissue penetration depth, which seriously limits PDT treatment and is also very likely to cause photodamage effects in biological tissues, making the application of PDT limited to the treatment of superficial sites or small tumors, and difficult to be widely used in the deep part of the body.

[0005] In terms of clinical application, TACE is already quite mature in the clinical treatment of liver cancer, while PDT is still mainly in the research stage. The aforementioned patented device is non-invasive and difficult to be widely used in the deep part of the body. Liver cancer is a deep tumor in the body, so PDT has not yet been widely used in the clinical treatment of liver cancer. Therefore, there is an urgent need for an innovative composite interventional catheter system that can combine TACE with PDT to improve the treatment effect and expand the application potential of PDT in the treatment of liver cancer. Summary of the invention

[0006] The present invention aims to solve the technical problems in the prior art of arterial chemoembolization and photodynamic therapy, such as lack of an efficient integrated catheter system, inconvenient operation, limited treatment effect, and inability to act deep inside the body. The purpose of the present invention is to provide a catheter system for arterial chemoembolization and photodynamic therapy.

[0007] To achieve the above-mentioned purpose, the present invention adopts the following technical scheme: a catheter system for transarterial chemoembolization and photodynamic therapy, comprising a catheter body that can be inserted into an artery, the catheter body comprising an inner tube and an outer tube arranged outside the inner tube; the inner tube has a cavity for storing and transporting drugs, the front end of the inner tube has a drug outlet communicating with the cavity, and the inner tube also has a drug addition port communicating with the cavity; an optical fiber connected to a laser light source is arranged in the space between the inner tube and the outer tube, and the light output by the optical fiber can be output through the front end between the inner tube and the outer tube.

[0008] In the above technical solution, during TACE, the inner tube is used to release chemical drugs and embolic materials and deliver them to the tumor supply artery. During PDT, the inner tube is used to deliver photosensitizers; the laser emitted by the optical fiber between the inner tube and the outer tube is used to activate the photosensitizer in the tumor tissue, generate reactive oxygen, and kill tumor cells. The present invention achieves PDT deep in the body in a minimally invasive interventional manner by arranging an optical fiber between the inner tube and the outer tube. This is the first time that photodynamic therapy (PDT) has been applied to the clinical treatment of liver cancer in an interventional manner, which is interventional photodynamic therapy; and TACE and PDT are combined in a catheter system, and TACE and PDT can be performed with one intubation, which reduces the number of intubations for patients, simplifies the treatment process, and improves the comfort of patients. The present invention creatively integrates photodynamic therapy (PDT) with transarterial chemoembolization (TACE), and is an innovative composite interventional treatment technology that belongs to the category of comprehensive treatment strategies.

[0009] In a preferred embodiment of the present invention, a microvalve for controlling the release rate is provided at the drug outlet; and / or a sealing cap for sealing the drug addition port is provided at the drug addition port.

[0010] The above technical solution, by setting a microvalve and adjusting the opening of the microvalve to control the release rate of drugs (including chemotherapy drugs, embolic materials and photosensitizers), ensures that the drugs can be released quickly and accurately during TACE and PDT; and by setting a cover, external contaminants are prevented from entering the cavity, which is more hygienic.

[0011] In a preferred embodiment of the present invention, the optical fiber is a solid optical fiber or a hollow optical fiber; the optical fiber includes a plurality of optical fibers arranged in the space between the inner tube and the outer tube, and the plurality of optical fibers are arranged at intervals along the circumference of the inner tube; or the optical fiber includes a hollow optical fiber arranged in the space between the inner tube and the outer tube.

[0012] The above technical solution provides two implementation methods: one is to set multiple optical fibers and the other is to set a hollow optical fiber, which can be selected according to actual conditions.

[0013] In a preferred embodiment of the present invention, the end of the optical fiber is a tapered structure.

[0014] In the above technical solution, the end of the optical fiber is tapered, which can enhance the divergence angle of light, ensure that the laser can deeply irradiate the tumor tissue, and improve the effectiveness of photodynamic therapy.

[0015] In a preferred embodiment of the present invention, a light-guiding prism is provided at the front end between the inner tube and the outer tube, and the light output by the optical fiber can be emitted after passing through the light-guiding prism and form a light spot.

[0016] The above technical solution adjusts the angle of the laser emitted by the optical fiber by setting a light-guiding prism to meet different treatment needs.

[0017] In another preferred embodiment of the present invention, the front end of the inner tube extends out of the outer tube, the front end of the inner tube is hemispherical, and the front end of the outer tube smoothly transitions to the outer wall of the inner tube.

[0018] The above technical solution, with its hemispherical shape and smooth transition, is more conducive to the insertion of the catheter body into the artery and reduces damage to the patient compared with a flat surface and steps.

[0019] In another preferred embodiment of the present invention, the medicine outlet hole is a side hole provided on the side wall of the inner tube extending out of the outer tube.

[0020] In the above technical solution, the drug outlet hole is arranged on the side wall of the inner tube, which can reduce the damage of the side wall of the drug outlet hole to the patient when the catheter body is inserted into the artery.

[0021] In another preferred embodiment of the present invention, the front end of the inner tube is also provided with a guide head connected to a monitoring device for guiding the catheter body to be inserted into the artery, and a force conduction identification device.

[0022] The above technical solution, by setting up a guide head and a force conduction identification device, can observe the state of the catheter body in real time during the insertion and positioning process, while realizing the measurement of direction and size, and accurately positioning to the proximal end of the tumor tissue (such as liver cancer cells, liver malignant tumors) without affecting the normal blood vessels nearby, thereby reducing damage to the patient.

[0023] In another preferred embodiment of the present invention, the end of the outer tube away from the medicine outlet is fixedly connected to a wire holder located outside the inner tube, the input end of the optical fiber passes through the wire holder and is connected to a plug connector, and the optical fiber is connected to the laser light source through the plug connector.

[0024] In the above technical solution, the wire seat plays a guiding and limiting role, which is conducive to the smooth passage of the optical fiber out of the outer tube; the plug connector is provided to facilitate the quick connection of the optical fiber and the laser light source.

[0025] Compared with the prior art, the preferred technical solution of the present invention has the following beneficial effects:

[0026] 1) Innovative integrated design: Combining TACE and PDT in one catheter system achieves the synergistic effect of the two treatment methods. This innovative composite interventional treatment technology combines minimally invasive interventional medicine and photodynamic therapy technology, improves the uniformity and pertinence of the treatment effect, and increases the feasibility of treating deep liver tumors. It is the first time that PDT therapy has been used in the clinical treatment of deep tumors (such as liver cancer), which has promoted the application of photodynamic therapy in the treatment of hepatocellular carcinoma and provided patients with a safer and more effective new treatment option.

[0027] 2) Precision treatment: By combining chemotherapy drugs, precise delivery of embolic materials and photodynamic therapy, the treatment effect of hepatocellular carcinoma can be improved and the recurrence rate can be reduced.

[0028] 3) Simplified operation process: The catheter system is integratedly designed, and TACE and PDT can be performed with one intubation, which reduces the number of intubations for patients, simplifies the treatment process, reduces the medical risks of patients, improves the convenience and comfort of treatment, and improves the overall treatment experience of patients.

[0029] Additional aspects and advantages of the present invention will be given in part in the following description and in part will be obvious from the following description, or will be learned through practice of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The above and / or additional aspects and advantages of the present invention will become apparent and easily understood from the description of the embodiments in conjunction with the following drawings, in which:

[0031] Figure 1 It is a schematic diagram of the structure of the catheter system for transarterial chemoembolization and photodynamic therapy of the first embodiment.

[0032] Figure 2 yes Figure 1 AA partial section diagram Figure 1 .

[0033] Figure 3 yes Figure 1 AA partial section diagram Figure 2 .

[0034] Figure 4 It is a schematic diagram of the structure of the catheter system for transarterial chemoembolization and photodynamic therapy of the second embodiment.

[0035] The reference numerals in the drawings of the specification include: catheter body 1, inner tube 2, cavity 21, drug outlet hole 22, drug addition port 23, outer tube 3, optical fiber 4, wire holder 5, plug connector 6, guide head 7, light guide prism 8. DETAILED DESCRIPTION

[0036] Embodiments of the present invention are described in detail below, and 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 only used to explain the present invention, and cannot be understood as limiting the present invention.

[0037] In the description of the present invention, it is to be understood that the terms “longitudinal”, “lateral”, “vertical”, “up”, “down”, “front”, “back”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside” and “outside” etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0038] In the description of the present invention, unless otherwise specified and limited, it should be noted that the terms "installed", "connected" and "connected" should be understood in a broad sense. For example, it can be a mechanical connection or an electrical connection, or it can be the internal connection between two components. It can be a direct connection or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to the specific circumstances.

[0039] Embodiment 1

[0040] The present invention provides a catheter system for transarterial chemoembolization and photodynamic therapy, such as Figure 1 As shown, in a preferred embodiment, the catheter system comprises a catheter body 1 that can be inserted into an artery, and the rear end ( Figure 1 The upper end shown in the figure is connected to the operating handle for the operator to hold and operate the movement of the catheter body 1; the catheter body 1 is a microcatheter, which is made of biocompatible material and has good flexibility, and is easy to operate in a blood vessel. For example, the material of the microcatheter disclosed in CN201710103523.2 is used, which is a prior art and will not be described in detail here.

[0041] The catheter body 1 comprises an inner tube 2 and an outer tube 3 arranged around the inner tube 2. The inner tube 2 and the outer tube 3 are both circular tubes and are arranged coaxially. The inner tube 2 has a plurality of parallel cavities 21 extending along its length for delivering drugs. The front end ( Figure 1The lower end of the inner tube 2 is shown as having a medicine outlet 22 communicating with each cavity 21, and the rear end of the inner tube 2 is provided with a medicine adding port 23 communicating with each cavity 21. An optical fiber 4 connected to an external laser light source is provided in the space between the inner tube 2 and the outer tube 3. The front end between the inner tube 2 and the outer tube 3 is closed and made of a light-transmitting material, and the light output by the optical fiber 4 can be output through the front end between the inner tube 2 and the outer tube 3. The optical fiber 4 is a hollow optical fiber or a solid optical fiber. The material of the optical fiber can adopt the existing technology, which is not the innovation of the present invention and will not be described in detail here.

[0042] When using the catheter system, under the guidance of imaging, the catheter body 1 is inserted into the patient's artery (such as the hepatic artery, for the treatment of hepatocellular carcinoma) to ensure its accurate position. The specific insertion method can adopt existing technology.

[0043] Drug and embolic material release during the TACE process: the drug enters the cavity 21 in the inner tube 2 from the drug adding port 23. Specifically, the drug can be injected into the cavity 21 from the drug adding port 23 by a drug adding pump or a syringe. The chemotherapy drug is directly delivered to the tumor blood supply artery from the drug outlet 22 through the cavity 21. At the same time, the embolic material (such as microspheres, gelatin sponge) is released through the cavity 21 to block the blood supply to the tumor.

[0044] Activation photodynamic therapy of the PDT process: the photosensitizer is delivered to the tumor tissue through the cavity 21, and then the laser light source is turned on to provide laser light of a specific wavelength, and the laser light is guided to the optical fiber 4 surrounded by the inner tube 2 and the outer tube 3. The optical fiber 4 emits the laser light to the tumor tissue, and the laser light activates the photosensitizer to generate reactive oxygen species, which further damages the tumor cells.

[0045] During the treatment, the blood flow status and light intensity of the liver need to be monitored in real time, and drug release and laser intensity need to be adjusted if necessary to ensure the best treatment effect.

[0046] It should be noted that, in order to facilitate the insertion of the catheter body 1, a guide wire can be provided for guidance, which is a conventional technique in the art and will not be described in detail herein. In addition, the catheter system can be provided with various sizes and specifications according to different age groups, genders, disease types, etc.

[0047] When inserting the vascular access, the patient is routinely placed in the supine position, the puncture site is disinfected, a drape is laid, and local infiltration anesthesia is performed. The femoral artery access is usually selected, and the radial artery access can also be selected if conditions permit. The Seldinger method is often used for percutaneous puncture and the catheter sheath is inserted. During arterial angiography, the celiac artery or common hepatic artery angiography is performed, and the angiographic image acquisition should include the arterial phase, the parenchymal phase, and the venous phase. If it is found that the blood vessels in the liver area are sparse / absent or the tumor staining is incomplete, arterial angiography of the superior mesenteric artery, the left gastric artery, the inferior phrenic artery, the renal artery, the internal thoracic artery, the intercostal artery, the lumbar artery, etc. should be performed to find the ectopic origin of the hepatic artery and the collateral supply vessels of the extrahepatic artery.

[0048] During surgery, all the blood supplying arteries of the tumor need to be found and identified. Cone beam CT (CBCT) examination is recommended. Combined with preoperative imaging examination, the angiographic findings should be carefully analyzed to clarify the location, size, number, and blood supplying arteries of the tumor (evidence level 2, recommendation strength A). In addition, attention should be paid to the effects of different angiographic parameters on DSA images. For patients with severe liver cirrhosis and tumor thrombus in the main trunk and first-level branches of the portal vein, indirect portal vein angiography via the superior mesenteric artery or splenic artery is recommended to understand the portal vein blood flow.

[0049] The present invention provides multiple parallel cavities 21 extending along the length direction of the inner tube 2. When chemotherapy drugs and embolic materials need to be delivered separately, the chemotherapy drugs and embolic materials can be delivered by two cavities 21 respectively. When chemotherapy drugs and embolic materials can be delivered simultaneously or they do not need to be delivered by two separate cavities 21, the chemotherapy drugs and embolic materials can be delivered by one cavity 21. The specific use of chemotherapy drugs and embolic materials needs to be determined according to clinical decisions. Considering that the photosensitizer may react with the chemotherapy drugs or affect the effect, the photosensitizer is delivered by another parallel cavity. When X-ray development is used, contrast agents can also be added to the inner tube 2. At this time, another parallel cavity needs to be set up for delivering contrast agents. When X-ray development is not used, this cavity for delivering contrast agents alone may not be set up.

[0050] In another preferred embodiment, a microvalve (not shown in the figure) for controlling the release speed is provided at the drug outlet 22. During chemotherapy, the opening of the microvalve is controlled to control the release amount and speed of the drug, ensuring that the chemotherapy drug and embolic material can be quickly released during the TACE process. Preferably, a cover for sealing the drug addition port 23 is provided, and the cover is detachably connected to the drug addition port 23, such as threaded connection or clamping fixation.

[0051] like Figure 1 As shown, in the present invention, the front end of the inner tube 2 extends out of the outer tube 3, and the medicine outlet hole 22 is a side hole provided on the side wall of the inner tube 2 extending out of the outer tube 3; the front end of the inner tube 2 is hemispherical, and the front end of the outer tube 3 smoothly transitions with the outer wall of the inner tube 2, which is conducive to smoother insertion of the catheter body 1 into the artery.

[0052] In another preferred embodiment, the front end of the inner tube 2 is also provided with a guide head 7 connected to a monitoring device for guiding the catheter body 1 to be inserted into the artery. Specifically, ultrasound imaging, optical imaging or electrophysiological imaging can be used to guide the catheter body 1 to be inserted into the artery, which are all prior art and will not be described in detail here. Further preferably, a powerful conduction identification device (not shown in the figure) is provided at the front end of the inner tube 2, such as a method of identifying the front end force of a guide wire used by an optical fiber interventional guide wire that can realize multi-dimensional force measurement at the tip disclosed in CN202310253782.9, which is prior art and will not be described in detail here.

[0053] like Figure 1 As shown, in the present invention, the end of the outer tube 3 away from the medicine outlet 22 is fixedly connected to a wire holder 5 located outside the inner tube 2, and the input end of the optical fiber 4 passes through the wire holder 5 and is connected to a plug connector 6, and the optical fiber 4 is connected to the laser light source through the plug connector 6. When in use, the plug connector 6 is connected to the laser light source to achieve a quick connection between the optical fiber 4 and the laser light source. Preferably, the plug connector 6 is a quick-release connector for easy disassembly and maintenance.

[0054] like Figure 2 As shown, in one embodiment, the optical fiber 4 includes a plurality of optical fibers arranged in the space between the inner tube 2 and the outer tube 3, and the plurality of optical fibers 4 are arranged circumferentially at intervals along the outer circumference of the inner tube 2; Figure 3 As shown, in one embodiment, the optical fiber 4 includes a hollow optical fiber arranged in the space between the inner tube 2 and the outer tube 3.

[0055] In another preferred embodiment, the end of the optical fiber 4 is a tapered structure to increase the divergence angle of light.

[0056] Embodiment 2

[0057] The structural principle of this embodiment is basically the same as that of the first and second embodiments, except that Figure 4 As shown, in this embodiment, a light guide prism 8 is provided at the front end between the inner tube 2 and the outer tube 3. The light guide prism 8 is fixed (for example, glued) on the inner wall of the outer tube 3. The light output by the optical fiber 4 can be emitted after passing through the light guide prism 8 and form a light spot to irradiate the tumor site. In practice, according to different treatment needs, different light guide prisms 8 can be configured to change the angle of the laser output from the optical fiber 4, such as using a focusing prism (Fresnel lens) to make the laser energy output from the optical fiber 4 more concentrated, and using a diverging prism (Powell prism) to make the laser output from the optical fiber 4 diverge and evenly disperse to the edge.

[0058] In the description of this specification, the description with reference to the terms "preferred embodiment", "one embodiment", "some embodiments", "example", "specific example" or "some examples" etc. means that the specific features, structures, materials 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, the schematic representation of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner.

[0059] Although the 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 present invention, and that the scope of the present invention is defined by the claims and their equivalents.

Claims

1. A catheter system for transarterial chemoembolization and photodynamic therapy, characterized in that: The invention comprises a catheter body capable of being inserted into an artery, wherein the catheter body comprises an inner tube and an outer tube arranged around the inner tube; The inner tube has a plurality of parallel cavities extending along its length for delivering drugs, the front end of the inner tube has a drug outlet communicating with each cavity, and the inner tube is also connected to a drug adding port communicating with each cavity; An optical fiber connected to a laser light source is arranged in the space between the inner tube and the outer tube, and the light output by the optical fiber can be output through the front end between the inner tube and the outer tube.

2. The catheter system for transarterial chemoembolization and photodynamic therapy according to claim 1, characterized in that: A micro valve for controlling the release speed is provided at the medicine outlet; And / or the drug adding port is provided with a sealing cover for sealing the drug adding port.

3. The catheter system for transarterial chemoembolization and photodynamic therapy according to claim 1, characterized in that: The optical fiber is a solid optical fiber or a hollow optical fiber; The optical fiber includes a plurality of solid optical fibers arranged in the space between the inner tube and the outer tube, and the plurality of optical fibers are arranged circumferentially at intervals along the outer circumference of the inner tube; or the optical fiber includes a hollow optical fiber arranged in the space between the inner tube and the outer tube.

4. The catheter system for transarterial chemoembolization and photodynamic therapy according to claim 1, characterized in that: The end of the optical fiber is a tapered structure.

5. The catheter system for transarterial chemoembolization and photodynamic therapy according to any one of claims 1 to 4, characterized in that: A light-guiding prism is arranged at the front end between the inner tube and the outer tube, and the light output by the optical fiber can be emitted after passing through the light-guiding prism and form a light spot.

6. The catheter system for transarterial chemoembolization and photodynamic therapy according to any one of claims 1 to 4, characterized in that: The front end of the inner tube extends out of the outer tube, the front end of the inner tube is hemispherical, and the front end of the outer tube smoothly transitions to the outer wall of the inner tube.

7. The catheter system for transarterial chemoembolization and photodynamic therapy according to claim 6, characterized in that: The medicine outlet hole is a side hole arranged on the side wall of the inner tube extending out of the outer tube.

8. The catheter system for transarterial chemoembolization and photodynamic therapy according to any one of claims 1 to 4, characterized in that: The front end of the inner tube is also provided with a guide head connected to a monitoring device for guiding the catheter body to be inserted into an artery, and a force conduction identification device.

9. The catheter system for transarterial chemoembolization and photodynamic therapy according to any one of claims 1 to 4, characterized in that: The end of the outer tube away from the medicine outlet is fixedly connected with a wire holder located outside the inner tube, the input end of the optical fiber passes through the wire holder and is connected with a plug connector, and the optical fiber is connected to the laser light source through the plug connector.

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