Photodynamic balloon dilatation catheter and laser transmitter

Abstract

The invention relates to the technical field of interventional medical instruments, and discloses a photodynamic balloon dilatation catheter and a laser transmitter. The balloon is connected to the periphery of the far end of the catheter, and the balloon has a full state and a folded state; the outer surface of the balloon is suitable for being coated with a photosensitizer; the optical fiber assembly is arranged in the balloon, and the optical fiber assembly comprises an optical fiber and a shading tube arranged outside the optical fiber in a sleeving mode; the shading tube and the optical fiber are driven to slide relatively, so that the length of the optical fiber exposed out of the shading tube is adjusted. The light shielding tube and the optical fiber are driven to slide relatively, so that the light emitting length of the optical fiber in the balloon can be adjusted, and the treatment universality of the photodynamic balloon dilatation catheter is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a photodynamic balloon dilatation catheter. Background Art

[0002] Percutaneous interventional therapy has become one of the commonly used treatment technologies worldwide. For intravascular stenosis lesions, balloon dilatation or stent implantation is usually used for treatment in the existing technology. However, for balloon dilatation treatment, after balloon dilatation, the endothelial damage and elastic fiber rupture of the dilated artery segment will cause thrombosis and intimal hyperplasia; and the balloon has a short expansion time during use and lacks long-term support, which leads to problems of elastic retraction and remodeling of the vessel wall. In addition, for stent implantation treatment, the long-term placement of vascular stents will also act as foreign bodies and produce a proliferative response in the body, leading to restenosis in the vascular stent.

[0003] In order to solve the above problems, a new vascular treatment technology has emerged in recent years for intravascular stenosis lesions: natural vascular stents. The natural vascular stent treatment technology is to apply a photosensitizer on the surface of a balloon, transport the balloon to the target location of the blood vessel, and then expand the balloon and extend the photosensitizer to the blood vessel wall. After that, the optical fiber emits light of a specific wavelength to activate the photosensitizer, thereby inducing cross-linking of amino acid residues in the blood vessel wall, so that collagen and elastin are quickly combined, a stent is formed in situ, the lumen is kept unobstructed, and the blood vessel is healed and repaired. For example, the patent document with publication number CN114514046A discloses a catheter system for creating a natural vascular stent and repairing tissue function. It discloses that the drug on the balloon after expansion is activated by an optical fiber, thereby forming a stent in situ. However, the photodynamic balloon dilation catheter in the prior art cannot adjust the light emission length of the optical fiber according to the actual situation of different lesion sites of the patient. As a result, the operator cannot adjust the light emission length of the optical fiber according to the actual needs of different lesion sites of the patient, thereby activating the vascular repair material attached to the blood vessel wall through the balloon, thereby inducing cross-linking of proteins in the blood vessel wall to form a natural vascular stent. The problem of uncontrollable optical fiber light emission length in the prior art will seriously affect the therapeutic versatility of the photodynamic balloon dilatation catheter.

[0004] Therefore, how to realize an optical fiber for activating vascular repair materials with an adjustable luminous length, thereby solving the lack of versatility of existing photodynamic balloon dilatation catheter treatment, is a technical problem that needs to be solved urgently in this field. Summary of the invention

[0005] The present invention aims to provide a photodynamic balloon dilatation catheter to solve the defects of the existing photodynamic balloon dilatation catheter, that is, the optical fiber light emitting length cannot be adjusted and the catheter has poor versatility. To this end, the present invention provides a photodynamic balloon dilatation catheter, comprising:

[0006] Catheter;

[0007] A balloon, connected to the outer periphery of the distal end of the catheter, the balloon having a filled state and a folded state; the outer surface of the balloon is adapted to be coated with a photosensitizer; the photosensitizer is a catalyst for activating cross-linking of amino acid residues in the blood vessel wall, so that collagen and elastin are quickly combined to form a scaffold in situ;

[0008] An optical fiber assembly, disposed within the balloon, the optical fiber assembly comprising: an optical fiber, and a light-shielding tube sleeved outside the optical fiber; the light-shielding tube and the optical fiber are driven to slide relative to each other, so as to adjust the length of the optical fiber exposed from the light-shielding tube.

[0009] Optionally, the photodynamic balloon dilation catheter further comprises:

[0010] An optical fiber fixing member, fixedly connected to the optical fiber, a sliding gap is formed between the light-shielding tube and the optical fiber fixing member, so that the light-shielding tube is driven to slide relative to the optical fiber, thereby adjusting the length of the optical fiber exposed from the light-shielding tube.

[0011] Optionally, the optical fiber fixing member is an optical fiber connector;

[0012] The optical fiber connector is disposed at the proximal position of the optical fiber, one end of the optical fiber connector is fixedly connected to the optical fiber, and the other end is connected to a laser emitter.

[0013] Optionally, the photodynamic balloon dilation catheter further comprises:

[0014] A catheter hub, at the position of the optical fiber interface on the catheter hub, there is provided an optical fiber fixing valve for fixing the optical fiber assembly, blocking the fluid medium for filling the balloon from flowing out of the catheter hub; and the optical fiber fixing valve is frictionally slidably connected to the light-shielding tube on the optical fiber assembly;

[0015] When adjusting the distal end light-emitting length of the optical fiber, the optical fiber connector fixes the optical fiber to keep it stationary, the light-shielding tube is driven to slide, and is dynamically sealed with the optical fiber fixing valve to adjust the exposed length of the optical fiber;

[0016] After the adjustment of the distal end light-emitting length of the optical fiber is completed, the optical fiber fixing valve is used to fix the positions of the light-shielding tube and the optical fiber.

[0017] Optionally, the photodynamic balloon dilation catheter further comprises:

[0018] A scale indicating member, correspondingly arranged with the light-shielding tube, for indicating the light-emitting length of the optical fiber.

[0019] Optionally, the scale indicating component is disposed at a proximal position of the light-shielding tube between the fiber optic connector and the fiber optic fixing valve;

[0020] The scale indicating component is a scale disposed along the sliding path of the light-shielding tube.

[0021] Optionally, the photodynamic balloon dilation catheter further includes:

[0022] An identification code, which communicates with the laser emitter; the laser emitter identifies the model of the photodynamic balloon dilation catheter through the identification code, and the host of the laser emitter automatically adjusts the adapted treatment parameter information according to the identification code and recommends the light-emitting length parameter of the fiber optic exposed from the light-shielding tube; and, the laser emitter needs to identify the identification code before allowing laser emission, thereby ensuring the safety of laser operation.

[0023] Optionally, the identification code is a UDI two-dimensional code provided on the catheter seat.

[0024] Optionally, the catheter includes: an inner tube and an outer tube; a gap between the inner tube and the outer tube forms a balloon inflation cavity communicating with the balloon; the balloon inflation cavity communicates with a balloon inflation interface on the catheter seat to allow the balloon to switch between a fully inflated state and a folded state by inflating and discharging a fluid medium;

[0025] The inner cavity of the inner tube is a guide wire cavity for the guide wire to pass through; one end of the inner tube is a guide wire outlet, and the other end of the inner tube extends to the balloon.

[0026] Optionally, the light-shielding tube is made of PTFE material; and / or,

[0027] The inner cavity wall of the light-shielding tube is further provided with a smooth coating to reduce the relative friction between the light-shielding tube and the fiber optic; and / or,

[0028] The photosensitizer is naphthalimide dimer and its derivatives; and / or,

[0029] The outer surface of the balloon is further coated with a drug for inhibiting vascular restenosis for treating vascular stenosis and occlusion; the drug for inhibiting vascular restenosis includes: macrolide immunosuppressants, macrolide antibiotics, rapamycin, structural derivatives and functional analogs of rapamycin, everolimus, structural derivatives and functional analogs of everolimus, paclitaxel, taxanes, temsirolimus compounds, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus or temsirolimus or temsirolimus compounds, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus or temsirolimus compounds; and / or,

[0030] The light emitted from the distal end of the optical fiber has a wavelength of 400 nm to 500 nm to activate the photosensitizer. The light with a wavelength of 400 nm to 500 nm can crosslink amino acid residues in the blood vessel wall, enabling the rapid binding of collagen and elastin to form a scaffold in situ, forming a natural blood vessel scaffold to maintain the dilated blood vessel.

[0031] A laser emitter, comprising:

[0032] A laser, connected to the optical fiber, for realizing laser output and controlling the light emission at the distal end of the optical fiber;

[0033] An identification module, which is communicatively connected to the identification code on the photodynamic balloon dilation catheter to obtain the treatment parameter information of the photodynamic balloon dilation catheter.

[0034] Optionally, the identification module further comprises:

[0035] An interface status feedback module, for detecting the interface status of the laser and verifying the treatment parameter information of the photodynamic balloon dilation catheter.

[0036] Optionally, the laser emitter further comprises:

[0037] A power supply module, for providing the power required for the operation of each device;

[0038] Power management, for controlling the voltage of different power supplies to achieve current distribution;

[0039] Power control, the power control adjusts the power in a PWM manner and uses a power tube for power adjustment to meet the different power requirements during the operation of the laser emitter;

[0040] A main control board, for performing power monitoring, power control, temperature control, temperature monitoring, etc.; stopping laser output when the power exceeds the limit and the temperature exceeds the limit to ensure laser safety;

[0041] A display module, for realizing human-machine interaction.

[0042] A method for using a photodynamic balloon dilation catheter, comprising the following steps:

[0043] Step S1, guiding the photodynamic balloon dilation catheter to the blood vessel lesion site through a guide wire, and the balloon located at the outer peripheral position of the distal end of the catheter corresponds to the lesion site;

[0044] Step S2, injecting a fluid medium into the balloon through the balloon inflation interface into the balloon inflation cavity formed by the gap between the inner tube and the outer tube, so that the balloon is in a filled state; the filled balloon contacts the lesion tissue, and the photosensitizer and the drug for inhibiting blood vessel restenosis are applied to the lesion tissue position;

[0045] Step S3: Use a laser emitter to scan the UDI two-dimensional code on the catheter seat; the laser emitter identifies the model of the photodynamic balloon dilation catheter through the identification code and automatically adjusts the adapted treatment parameter information according to the identification code; meanwhile, the UDI two-dimensional code recommends the fiber optic luminescence length parameter of the photodynamic balloon dilation catheter to the operator.

[0046] Step S4: The operator pulls the light-shielding tube from the distal end to the proximal end of the photodynamic balloon dilation catheter according to the fiber optic luminescence length value provided by the scale indicating component, thereby increasing the luminescence length of the fiber in the balloon exposed from the light-shielding tube; or the operator pushes the light-shielding tube from the proximal end to the distal end of the photodynamic balloon dilation catheter, thereby reducing the luminescence length of the fiber in the balloon exposed from the light-shielding tube.

[0047] Step S5: Connect the fiber optic connector to the laser emitter to connect the laser to the fiber optic; the distal luminous part of the fiber optic emits light with a wavelength of 400 nm to 500 nm. Through the catalytic action of the photosensitizer, the amino acid residues in the blood vessel wall are activated to crosslink, so that collagen and elastin quickly combine to form a stent in situ, enabling the blood vessel dilated by the balloon to maintain the dilated state.

[0048] Step S6: Drain the fluid medium in the balloon through the above-mentioned balloon inflation cavity. After the balloon is depressurized, it is converted from the inflated state to the folded state; then, the photodynamic balloon dilation catheter is withdrawn from the body.

[0049] The technical solution of the present invention has the following advantages:

[0050] 1. For the photodynamic balloon dilation catheter provided by the present invention, a light-shielding tube is sleeved outside the fiber optic. And, relative sliding is allowed between the fiber optic and the light-shielding tube. The above structural setting can effectively achieve: the operator can adjust the length of the fiber optic in the balloon exposed from the light-shielding tube as needed. Furthermore, it enables the operator to adjust the fiber optic luminescence length according to the actual needs of different lesion sites of the patient. Thus, after the photosensitizer and the drug for inhibiting blood vessel restenosis are coated on the lesion tissue position through balloon inflation, the photosensitizer at the lesion tissue position is activated by the fiber optic with an adjustable luminescence length, and crosslinking of the amino acid residues in the blood vessel wall is induced at the accurate position to form a stent in situ. It effectively solves the problem that the fiber optic luminescence length of the photodynamic balloon dilation catheter in the prior art cannot be adjusted as needed, resulting in insufficient versatility in the treatment of the photodynamic balloon dilation catheter.

[0051] 2. For the photodynamic balloon dilation catheter provided by the present invention, the position of the fiber optic is fixed through the fiber optic connector, and a sliding gap is formed between the light-shielding tube and the fiber optic fixing member, thereby achieving: the light-shielding tube can be driven to slide relative to the length extension direction of the fiber optic. Through the above structure, the length of the fiber optic exposed from the light-shielding tube can be effectively adjusted.

[0052] In addition, the optical fiber connector in the present invention is also connected to a laser emitter, so as to receive the laser emitted by the laser emitter, so that the light-emitting part at the distal end of the optical fiber emits light with a wavelength of 400 nm to 500 nm. Through the catalytic action of the photosensitizer, the amino acid residues in the blood vessel wall are activated to crosslink, so that collagen and elastin are quickly combined to form a scaffold in situ.

[0053] 3. The photodynamic balloon dilation catheter provided by the present invention is provided with an optical fiber fixing valve at the optical fiber interface position of the catheter seat. The above-mentioned optical fiber fixing valve can block the outflow of the fluid medium used to inflate the balloon from the catheter seat, and at the same time, realize dynamic sealing of the light-shielding tube that can slide relative to the optical fiber, so as to ensure that the fluid medium will not overflow from the optical fiber interface position during the sliding process of the light-shielding tube relative to the optical fiber. And when the distal end light-emitting length of the optical fiber is adjusted, the optical fiber fixing valve can also be used to fix the positions of the light-shielding tube and the optical fiber.

[0054] 4. The photodynamic balloon dilation catheter provided by the present invention further includes: a scale indicating component. Through the above-mentioned scale indicating component, the light-emitting length parameter of the optical fiber can be effectively displayed, so as to facilitate the operator to correspondingly adjust the distal end light-emitting length of the optical fiber according to the prompt information or actual operation needs.

[0055] 5. The laser emitter provided by the present invention includes: an identification module corresponding to the identification code on the photodynamic balloon dilation catheter. Through the above-mentioned identification module, the laser emitter can effectively obtain the treatment parameter information of the photodynamic balloon dilation catheter. And according to the parameter information, the host of the laser emitter automatically completes the adjustment of the adapted treatment parameter information according to the identification code, and recommends the light-emitting length parameter of the optical fiber to the operator. BRIEF DESCRIPTION OF THE DRAWINGS

[0056] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0057] Figure 1 It is a schematic structural diagram of the photodynamic balloon dilation catheter provided by the present invention in a balloon inflated state;

[0058] Figure 2 It is an enlarged schematic diagram of the internal structure of the balloon in the photodynamic balloon dilation catheter provided by the present invention;

[0059] Figure 3Schematic diagram of the state of the photodynamic balloon dilation catheter provided by the present invention when the optical fiber exposes the light-shielding tube;

[0060] Figure 4 Provided by the present invention Figure 3 In it, a partially enlarged schematic diagram of the balloon in part A;

[0061] Figure 5 Schematic diagram of the component module of the laser emitter provided by the present invention.

[0062] Explanation of reference numerals:

[0063] 1 - Catheter; 2 - Balloon; 3 - Optical fiber; 4 - Light-shielding tube; 5 - Optical fiber connector; 6 - Catheter hub; 7 - Optical fiber fixing valve; 8 - Scale indicating component; 9 - Identification code; 10 - Inner tube; 11 - Outer tube; 12 - Drug coating; 13 - Vessel wall; 14 - Balloon inflation interface. Specific embodiments

[0064] Next, the technical solutions of the present invention will be clearly and completely described in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of them. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.

[0065] In the description of the present application, it should be understood that the terms "proximal end" and "distal end" throughout the text refer to near and far relative to the operator. When the present invention is in use, the end close to the doctor or operator is the "proximal end", that is, the end where the operator is located, and the end far from the doctor or operator is the "distal end", that is, the end where the balloon is located. The above-mentioned orientation description is only for the convenience of describing the present application 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 should not be construed as a limitation to the present application.

[0066] Refer to Figure 1 The schematic diagram of the structure of the photodynamic balloon dilation catheter in the embodiment of the present invention shown, in the balloon inflation state. The photodynamic balloon dilation catheter includes: a catheter 1, a balloon 2 and an optical fiber assembly; the above-mentioned balloon 2 is connected to the outer periphery of the distal end of the catheter 1, and the balloon 2 has an inflation state and a folded state; the outer surface of the balloon 2 is suitable for coating with a photosensitizer. The above-mentioned photosensitizer is a catalyst for activating the cross-linking of amino acid residues in the vessel wall, so that collagen and elastin quickly combine to form a scaffold in situ. As Figure 2As shown, the optical fiber component in the present invention is disposed within the balloon 2. The optical fiber component includes: an optical fiber 3, and a light-shielding tube 4 sleeved outside the optical fiber 3. The light-shielding tube 4 is made of PTFE material. The light-shielding tube 4 and the optical fiber 3 are driven to slide relative to each other, so as to adjust the length of the optical fiber 3 exposed from the light-shielding tube 4, thereby activating the photosensitizer at the position of the diseased tissue according to the actual needs of the position of the diseased tissue, and inducing cross-linking of amino acid residues in the blood vessel wall at an accurate position to form a stent in situ. This effectively solves the problem in the prior art that the light-emitting length of the optical fiber of the photodynamic balloon dilation catheter cannot be adjusted as needed, resulting in insufficient versatility in the treatment of the photodynamic balloon dilation catheter.

[0067] In this embodiment, the position of the optical fiber 3 is fixed by an optical fiber connector 5 disposed at the proximal end of the optical fiber 3. At the same time, the connection between the optical fiber 3 and the laser emitter is realized through the optical fiber connector 5, and further the optical fiber 3 is enabled to receive the laser emitted by the laser emitter, so that the light-emitting part at the distal end of the optical fiber 3 emits light with a wavelength of 400 nm to 500 nm, activating the photosensitizer and triggering cross-linking of proteins in the blood vessel wall, thereby forming a natural blood vessel stent. In this embodiment, one end of the optical fiber connector 5 is fixedly connected to the optical fiber 3, and the other end is connected to the laser emitter. The optical fiber connector 5 fixes the position of the optical fiber 3 and forms a sliding gap between the light-shielding tube 4 and the optical fiber fixing member, so that the light-shielding tube 4 is driven to slide relative to the optical fiber 3, thereby adjusting the length of the optical fiber 3 exposed from the light-shielding tube 4. The operator can adjust the length of the optical fiber 3 exposed from the light-shielding tube 4 within the balloon 2 as needed, and further enable the operator to adjust the light-emitting length of the optical fiber according to the actual needs of different diseased parts of the patient.

[0068] During the actual use process, it includes the following operation steps: Step S1, guiding the photodynamic balloon dilation catheter to the position of the blood vessel lesion through a guide wire, and the balloon 2 located at the distal outer peripheral position of the catheter 1 corresponds to the lesion position. Step S2, injecting a fluid medium into the balloon 2 through the balloon filling interface 14 into the balloon filling cavity surrounded by the gap between the inner tube 10 and the outer tube 11, so that the balloon 2 is in a filled state; the filled balloon 2 contacts the diseased tissue, and the photosensitizer and the drug for inhibiting blood vessel restenosis are coated on the position of the diseased tissue. Step S3, the operator adjusts the light-emitting length of the optical fiber 3 as needed. Such as Figure 3As shown, specifically: pull the light-shielding tube 4 from the distal end to the proximal end of the photodynamic balloon dilation catheter, thereby increasing the luminous length of the optical fiber 3 exposed from the light-shielding tube 4 in the balloon 2; or, the operator pushes the light-shielding tube 4 from the proximal end to the distal end of the photodynamic balloon dilation catheter, thereby reducing the luminous length of the optical fiber 3 exposed from the light-shielding tube 4 in the balloon 2. Step S4: Connect the optical fiber connector 5 to the laser emitter, and send laser light to the light-emitting part at the head of the optical fiber 3 through the laser emitter, so that the light-emitting part at the distal end of the optical fiber 3 emits light with a wavelength of 400 nm to 500 nm, activate the photosensitizer, and trigger the cross-linking of proteins in the blood vessel wall, thereby forming a natural blood vessel stent, so that the blood vessel dilated by the balloon 2 maintains the dilated state. Step S5: Drain the fluid medium in the balloon 2 through the above-mentioned balloon filling cavity. After the balloon 2 is depressurized, it is converted from the inflated state to the folded state; then, withdraw the photodynamic balloon dilation catheter from the body.

[0069] Further, in a specific embodiment, a smooth coating is further provided on the inner cavity wall of the light-shielding tube 4 to reduce the relative friction between the light-shielding tube 4 and the optical fiber 3.

[0070] In another specific embodiment, the light-shielding tube 4 can also be kept stationary, and the optical fiber 3 is driven to expand and contract in the light-shielding tube 4, so as to realize the adjustment of the length of the optical fiber 3 exposed from the light-shielding tube 4.

[0071] In another specific embodiment, the light-shielding tube 4 can also be adjusted to other materials with a smooth inner cavity according to needs.

[0072] In this embodiment, further, since the balloon 2 needs to be filled with a fluid medium, it is also necessary to seal the position of the optical fiber interface on the catheter seat 6 to prevent the fluid medium from flowing out of the catheter seat 6. This requires dynamic sealing of the light-shielding tube 4 slidably arranged relative to the optical fiber 3, so as to ensure that the fluid medium does not overflow from the optical fiber interface position during the sliding of the light-shielding tube 4 relative to the optical fiber 3. Refer to Figure 3 The state diagram of the photodynamic balloon dilation catheter shown when the optical fiber is exposed from the light-shielding tube. The photodynamic balloon dilation catheter further includes: a catheter seat 6. At the position of the optical fiber interface on the catheter seat 6, there is an optical fiber fixing valve 7 for fixing the optical fiber assembly to prevent the fluid medium for filling the balloon 2 from flowing out of the catheter seat 6; and the optical fiber fixing valve 7 is frictionally slidably connected to the light-shielding tube 4 on the optical fiber assembly. When adjusting the luminous length of the distal end of the optical fiber 3, the optical fiber connector 5 fixes the optical fiber 3 to keep it stationary, and the light-shielding tube 4 is driven to slide, and is dynamically sealed with the optical fiber fixing valve 7 to adjust the exposed length of the optical fiber 3;

[0073] After the adjustment of the luminous length of the distal end of the optical fiber 3 is completed, the optical fiber fixing valve 7 is used to fix the positions of the light-shielding tube 4 and the optical fiber 3.

[0074] In another specific embodiment, the optical fiber fixing valve 7 can also be arranged inside the catheter seat 6 according to needs instead of at the optical fiber interface position on the catheter seat 6.

[0075] In this embodiment, further, when an operator adjusts the distal light-emitting length of the optical fiber 3, a scale indication mark is also required to tell the operator the length of the light-emitting of the optical fiber 3. The photodynamic balloon dilation catheter in this embodiment further includes: a scale indication component 8, which is correspondingly arranged with the light-shielding tube 4 and is used to indicate the light-emitting length of the optical fiber 3. As Figure 1 and Figure 3 shown, the scale indication component 8 is arranged between the optical fiber connector 5 and the optical fiber fixing valve 7 and at the proximal position of the light-shielding tube 4. The above scale indication component 8 is a scale arranged along the sliding path of the light-shielding tube 4.

[0076] In another specific embodiment, the specific value of the light-emitting length of the optical fiber 3 exposed from the light-shielding tube 4 can also be directly detected by a position sensor.

[0077] In this embodiment, further, in order to help the operator complete the adjustment work of the host parameters of the laser emitter. And recommend the reference data of the light-emitting length of the optical fiber 3 to the operator. On the catheter seat 6 of the photodynamic balloon dilation catheter in this embodiment, an identification code is also set, and this identification code can be a UDI two-dimensional code. This identification code 9 communicates with the laser emitter; the laser emitter identifies the model of the photodynamic balloon dilation catheter through the identification code 9, and the host of the laser emitter automatically completes the adjustment of the adapted treatment parameter information according to the identification code 9 and recommends the light-emitting length parameter of the optical fiber 3 exposed from the light-shielding tube 4; and, the laser emitter needs to identify the above identification code 9 before it can allow laser emission, thereby ensuring the safety of laser work.

[0078] In another specific embodiment, the identification code 9 can also be set as a bar code or other coding forms according to needs. At the same time, the identification code 9 can be set at other positions of the photodynamic balloon dilation catheter according to needs, such as on the instruction manual.

[0079] In this embodiment, specifically, as Figure 1 and Figure 2 shown, the catheter 1 includes: an inner tube 10 and an outer tube 11; the gap between the inner tube 10 and the outer tube 11 forms a balloon inflation cavity communicating with the balloon 2; the balloon inflation cavity communicates with the balloon inflation interface 14 on the catheter seat 6 to switch the balloon 2 between the inflated state and the folded state by inflating and discharging a fluid medium; the inner cavity of the inner tube 10 is a guide wire cavity for the guide wire to pass through; one end of the inner tube 10 is a guide wire outlet, and the other end of the inner tube 10 extends to the balloon 2.

[0080] In this embodiment, specifically, as Figure 3 andFigure 4 As shown, the drug coating 12 coated on the outer surface of the balloon 2 includes: the drug coating 12. When the balloon 2 is in the inflated state, the drug coating 12 adheres to the blood vessel wall 13. The drug coating 12 includes: a photosensitizer and a drug for inhibiting vascular restenosis. The photosensitizer is naphthalimide dimer and its derivatives. In addition, the drug for inhibiting vascular restenosis is used to treat vascular stenosis and occlusion. The drug for inhibiting vascular restenosis includes: macrolide immunosuppressants, macrolide antibiotics, rapamycin, structural derivatives and functional analogs of rapamycin, everolimus, structural derivatives and functional analogs of everolimus, paclitaxel, taxanes, temsirolimus compounds, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus or temsirolimus or temsirolimus compounds, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus or temsirolimus compounds.

[0081] In this embodiment, the photodynamic balloon dilation catheter system includes: a photodynamic balloon dilation catheter and a laser emitter cooperatively connected to the photodynamic balloon dilation catheter.

[0082] A laser emitter, as Figure 5 shown, which includes:

[0083] A power supply module for providing the power required for the operation of each device;

[0084] Power management for controlling the voltages of different power supplies to achieve current distribution;

[0085] A laser, connected to the optical fiber 3, for realizing laser output and controlling the light emission at the distal end of the optical fiber 3;

[0086] Power control, where the power control adjusts the power in a PWM manner and uses a power transistor for power adjustment to meet the different power requirements during the operation of the laser emitter;

[0087] A main control board for performing power monitoring, interface monitoring, temperature control, temperature monitoring, etc.; stopping the laser output when the power exceeds the limit and the temperature exceeds the limit to ensure laser safety;

[0088] A display module for realizing human-machine interaction.

[0089] In this embodiment, further, the laser emitter further includes:

[0090] An identification module, which is communicatively connected to the identification code 9 on the photodynamic balloon dilation catheter to obtain the treatment parameter information of the photodynamic balloon dilation catheter; through the above-mentioned identification module, the laser emitter can effectively obtain the treatment parameter information of the photodynamic balloon dilation catheter. And according to this parameter information, the host of the laser emitter automatically adjusts the adapted treatment parameter information according to the identification code 9, and recommends the light-emitting length parameter of the optical fiber 3 to the operator;

[0091] An interface status feedback module, which is used to detect the interface status of the laser and verify the treatment parameter information of the photodynamic balloon dilation catheter.

[0092] A method for using a photodynamic balloon dilation catheter, comprising the following steps:

[0093] Step S1, guiding the photodynamic balloon dilation catheter to the vascular lesion position through a guide wire, and the balloon 2 located at the distal peripheral position of the catheter 1 corresponds to the lesion position;

[0094] Step S2, injecting a fluid medium into the balloon 2 through the balloon inflation interface 14 into the balloon inflation cavity surrounded by the gap between the inner tube 10 and the outer tube 11, so that the balloon 2 is in a filled state; the filled balloon 2 contacts the diseased tissue, and the photosensitizer and the drug for inhibiting vascular restenosis are applied to the diseased tissue position;

[0095] Step S3, using the laser emitter to scan the identification code on the catheter seat 6; the laser emitter identifies the model of the photodynamic balloon dilation catheter through the identification code 9, and automatically adjusts the adapted treatment parameter information according to the identification code 9; at the same time, the UDI two-dimensional code recommends the light-emitting length parameter of the optical fiber 3 of the photodynamic balloon dilation catheter to the operator;

[0096] Step S4, the operator pulls the light-shielding tube 4 from the distal end to the proximal end of the photodynamic balloon dilation catheter according to the light-emitting length value of the optical fiber 3 provided by the scale indicating component 8, thereby increasing the light-emitting length of the optical fiber 3 exposed from the light-shielding tube 4 in the balloon 2; or, the operator pushes the light-shielding tube 4 from the proximal end to the distal end of the photodynamic balloon dilation catheter, thereby reducing the light-emitting length of the optical fiber 3 exposed from the light-shielding tube 4 in the balloon 2;

[0097] Step S5, connecting the optical fiber connector 5 to the laser emitter, so that the laser is connected to the optical fiber 3; the distal light-emitting part of the optical fiber 3 emits light with a wavelength of 400 nm to 500 nm, activating the photosensitizer and triggering the cross-linking of proteins in the blood vessel wall, thereby forming a natural blood vessel stent, so that the blood vessel dilated by the balloon 2 maintains the dilated state;

[0098] Step S6, discharging the fluid medium in the balloon 2 through the above-mentioned balloon inflation cavity, and after the balloon 2 is depressurized, it is converted from the filled state to the folded state; then, the photodynamic balloon dilation catheter is withdrawn from the body.

[0099] Obviously, the above embodiments are merely examples for clear illustration and not limitations on the implementation manners. For those of ordinary skill in the art, other different forms of changes or alterations can be made based on the above description. It is not necessary and impossible to enumerate all implementation manners here. And the obvious changes or alterations derived therefrom still fall within the protection scope of the present invention.

Claims

1. A photodynamic balloon dilatation catheter, characterized in that: include: Catheter (1); A balloon (2) connected to the outer periphery of the distal end of the catheter (1), the balloon (2) having a filled state and a folded state; The outer surface of the balloon (2) is suitable for coating a photosensitizer; An optical fiber assembly is arranged in the balloon (2), and comprises: an optical fiber (3), and a light shielding tube (4) sleeved outside the optical fiber (3); The light-shielding tube (4) and the optical fiber (3) are driven to slide relative to each other, thereby adjusting the length of the optical fiber (3) exposed from the light-shielding tube (4).

2. The photodynamic balloon dilatation catheter according to claim 1, characterized in that: Photodynamic balloon dilatation catheter, also includes: An optical fiber fixing part is fixedly connected to the optical fiber (3), and a sliding gap is formed between the light-shielding tube (4) and the optical fiber fixing part, so that the light-shielding tube (4) is driven to slide relative to the optical fiber (3), thereby adjusting the length of the optical fiber (3) exposed from the light-shielding tube (4).

3. The photodynamic balloon dilatation catheter according to claim 2, characterized in that: The optical fiber fixing part is an optical fiber connector (5); The optical fiber connector (5) is arranged at the proximal end of the optical fiber (3); one end of the optical fiber connector (5) is fixedly connected to the optical fiber (3), and the other end is connected to the laser emitter.

4. The photodynamic balloon dilatation catheter according to claim 3, characterized in that: Also includes: A catheter seat (6), wherein a fiber optic fixing valve (7) for fixing the fiber optic assembly is provided at the fiber optic interface position on the catheter seat (6) to prevent the fluid medium for filling the balloon (2) from flowing out of the catheter seat (6); and the fiber optic fixing valve (7) is frictionally and slidably connected to the light shielding tube (4) on the fiber optic assembly; When adjusting the far-end luminous length of the optical fiber (3), the optical fiber connector (5) fixes the optical fiber (3) to keep it stationary, and the light shielding tube (4) is driven to slide and dynamically seal with the optical fiber fixing valve (7) to adjust the exposed length of the optical fiber (3); When the distal light emitting length of the optical fiber (3) is adjusted, the optical fiber fixing valve (7) is used to fix the positions of the light shielding tube (4) and the optical fiber (3).

5. The photodynamic balloon dilatation catheter according to claim 4, characterized in that: Also includes: a scale indicating component (8), arranged corresponding to the light shielding tube (4) and used to indicate the luminous length of the optical fiber (3); The scale indicating component (8) is arranged between the optical fiber connector (5) and the optical fiber fixing valve (7) and at the proximal end of the light shielding tube (4); The scale indicating component (8) is a scale ruler arranged along the sliding path of the light shielding tube (4).

6. The photodynamic balloon dilatation catheter according to claim 4, characterized in that: Also includes: an identification code (9), the identification code (9) communicating with the laser transmitter; The laser transmitter identifies the model of the photodynamic balloon dilatation catheter through the identification code (9), and the host of the laser transmitter automatically completes the adjustment of the adapted treatment parameter information according to the identification code (9), and recommends the luminous length parameter of the optical fiber (3) exposed from the light-shielding tube (4); and the laser transmitter is required to identify the identification code (9) before allowing laser emission.

7. The photodynamic balloon dilatation catheter according to claim 1, characterized in that: The catheter (1) comprises: an inner tube (10) and an outer tube (11); a gap between the inner tube (10) and the outer tube (11) forms a balloon filling cavity connected to the balloon (2); the balloon filling cavity is connected to a balloon filling interface (14) on the catheter seat (6) so as to switch the balloon (2) between a filled state and a folded state by filling and discharging a fluid medium; The inner cavity of the inner tube (10) is a guidewire cavity for a guidewire to pass through; one end of the inner tube (10) is a guidewire outlet, and the other end of the inner tube (10) extends to the balloon (2).

8. The photodynamic balloon dilatation catheter according to claim 1, characterized in that: The light shielding tube (4) is made of PTFE; and / or, The inner cavity wall of the light-shielding tube (4) is also provided with a smooth coating to reduce the relative friction between the light-shielding tube (4) and the optical fiber (3); and / or, The photosensitizer is naphthalimide dimer and its derivatives; and / or, The outer surface of the balloon (2) is also coated with a drug for inhibiting vascular restenosis; the drug for inhibiting vascular restenosis includes: macrolide immunosuppressants, macrolide antibiotics, rapamycin, structural derivatives and functional analogs of rapamycin, everolimus, structural derivatives and functional analogs of everolimus, paclitaxel, taxanes, temsirolimus compounds, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus or temsirolimus or temsirolimus compounds, zotarolimus, everolimus, sirolimus, biolimus, tacrolimus or temsirolimus compounds; and / or, The light emitted from the far end of the optical fiber (3) has a wavelength of 400nm to 500nm to activate the photosensitizer.

9. A laser transmitter, characterized in that: include: A laser connected to the optical fiber (3) for realizing laser output and controlling the light emission at the far end of the optical fiber (3); An identification module, wherein the identification module is communicatively connected to an identification code (9) on the photodynamic balloon dilatation catheter according to any one of claims 1 to 8 to obtain treatment parameter information of the photodynamic balloon dilatation catheter.

10. The laser transmitter according to claim 9, characterized in that: The identification module also includes: The interface status feedback module is used to detect the interface status of the laser and verify the treatment parameter information of the photodynamic balloon dilatation catheter.

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