CN117462241A - Vascular repair system and control method - Google Patents
Vascular repair system and control method Download PDFInfo
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- CN117462241A CN117462241A CN202210869431.6A CN202210869431A CN117462241A CN 117462241 A CN117462241 A CN 117462241A CN 202210869431 A CN202210869431 A CN 202210869431A CN 117462241 A CN117462241 A CN 117462241A
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- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
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- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
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- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
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Abstract
The invention relates to the technical field of medical equipment, and provides a vascular repair system and a control method, wherein the vascular repair system comprises: the laser generation module is used for generating first laser for repairing the inner wall of the blood vessel and second laser for ablating target tissues in the blood vessel, and the wavelength range of the first laser is 600 nm-1064 nm; and the output module is used for being intervened in a blood vessel and transmitting the first laser and the second laser. The repair system integrates the functions of vascular wall repair and vascular ablation, improves the ablation efficiency and safety, reduces the operation risk to the minimum, improves the treatment effect by using laser repair, solves the problem that the vascular wall repair is not timely after the ablation commonly existing in vascular operation, improves the effectiveness and reliability of the operation, greatly reduces postoperative complications and dependence on medicines after the operation, and reduces the infection rate and the vascular restenosis hidden trouble during and after the operation.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a vascular repair system and a control method.
Background
Atherosclerosis is a chronic lesion of the inner wall of blood vessels characterized by lipid accumulation and inflammation, which is well developed in large and medium arteries, and its pathological processes include vascular inflammation, endothelial injury, phenotypic transformation and migration proliferation of vascular smooth muscle cells, foam cell formation, cell death, lipid and cholesterol accumulation, thrombosis, etc.
The existing treatment mode of atherosclerosis is usually mechanical thrombus taking, and the mechanical thrombus taking has the advantages of high vascular recanalization rate, low cerebral hemorrhage incidence rate, recanalization time, prolonged treatment time window and the like. Mechanical thrombolysis also has the defects of low accuracy, delayed vascular recanalization due to operation preparation and operation, high requirements on operators and equipment, and the like.
On the basis, a mode of treating atherosclerosis by laser angioplasty is provided, and the mode utilizes a laser product to combine with optical fibers for carrying out vascular treatment on atherothrombosis and hemi atherothrombosis, and particularly, the optical fibers are conveyed into blood vessels, laser is transmitted through the optical fibers, and the atherothrombosis and the thrombi of coronary arteries and peripheral blood vessels are opened through the laser, so that an effective and novel treatment means are opened by vascular recanalization. The laser ablates atheromatous plaque tissues to form blood vessels according to the emission characteristics of radioactive substances and the mode of energy transfer to tissues through thermal effect, photoacoustic injury, photochemistry and other action mechanisms, and the main mechanism is to destroy and ablate target tissues through photochemistry and photomechanical action.
Although laser angioplasty can remove thrombus by laser, the safety problem of embolism still exists at present, and laser can easily damage the inner wall of a blood vessel while removing plaque and thrombus, and the restenosis of the blood vessel after the vascular operation is easy to occur in the processes of wound healing and proliferation.
Disclosure of Invention
The invention aims to provide a vascular repair system and a control method, wherein the vascular repair system integrates the functions of repairing the inner wall of a blood vessel and ablating and recanalizing the blood vessel, can repair the inner wall of the blood vessel after ablating and recanalizing, and lightens the thickening degree of an intima in the repair process of a vascular injury so as to prevent restenosis after ablation.
The present invention provides a vascular repair system comprising:
the laser generation module is used for generating first laser for repairing the inner wall of the blood vessel and second laser for ablating target tissues in the blood vessel, and the wavelength range of the first laser is 600 nm-1064 nm;
and the output module is used for being intervened in a blood vessel and transmitting the first laser and the second laser.
Further, the energy density of the first laser generated by the laser generating module is adjustable.
Further, the wavelength range of the second laser is 198nm to 400nm.
Further, the output module includes a first output member for transmitting the first laser light and irradiating the first laser light to an inner wall of the blood vessel, and a second output member for transmitting the second laser light and irradiating the second laser light to a target tissue within the blood vessel.
Further, the vascular repair system further includes a delivery catheter for implantation within the vessel to form a delivery channel, the delivery catheter having a lumen for introducing the first delivery member or the second delivery member into the vessel through the lumen; alternatively, the delivery catheter has two lumens for simultaneously introducing the first and second delivery members into the vessel through the two lumens, respectively.
Further, the first output piece is a dispersion optical fiber, a bundling optical fiber or a lateral output optical fiber; and/or, the second output piece is a bundled optical fiber.
Further, the laser generating module includes a semiconductor laser for generating the first laser light and an ultraviolet laser for generating the second laser light.
Further, the vascular repair system further comprises a control module, wherein the control module is in communication connection with the laser generation module and is used for controlling the light emitting mode of the laser generation module, and the light emitting mode at least comprises a first laser independent light emitting mode, a second laser independent light emitting mode and a first laser and second laser simultaneous light emitting mode.
Further, the control module is further configured to: and controlling the starting of the first laser single light emitting mode to be after the starting of the second laser single light emitting mode.
Further, the vascular repair system further comprises a power supply module, wherein the power supply module is used for supplying power to the laser generation module and the control module.
Further, the vascular repair system further comprises a blood pressure acquisition unit and an alarm module, wherein the blood pressure acquisition unit and the alarm module are both in communication connection with the control module, and the control module is further configured to: and receiving the blood pressure value of the intervened blood vessel acquired by the blood pressure acquisition unit, judging whether the blood pressure value is smaller than a set value, and controlling the alarm module to give an alarm if the blood pressure value is smaller than the set value.
The invention also provides a control method of the vascular repair system,
controlling the laser generation module to start and outputting a first laser for vascular repair and/or a second laser for ablation of target tissue in a blood vessel; and/or the number of the groups of groups,
and controlling the second laser to be independently output into the blood vessel, and controlling the first laser to be independently output into the blood vessel after delaying for a preset time.
Further, collecting blood pressure values in blood vessels, and judging the sizes of the blood pressure values relative to a set value;
and if the blood pressure value is greater than or equal to the set value, controlling the laser generating module to generate the first laser and/or the second laser.
In summary, the vascular repair system provided in the present invention includes:
the laser generation module is used for generating first laser for repairing the inner wall of the blood vessel and second laser for ablating target tissues in the blood vessel, and the wavelength range of the first laser is 600 nm-1064 nm;
and the output module is used for being intervened in a blood vessel and transmitting the first laser and the second laser.
So configured, the output module can irradiate laser light with a certain wavelength range on the inner wall of the blood vessel, and by utilizing the photo-biological regulation effect, energy and microstructure changes are generated depending on the absorption of light by chromophores existing in mitochondria and intracellular ion channels, so that cell signals are activated, transcription factors are up-regulated, and expression of protective genes is increased. Vascular endothelial cells are the main regulator of vascular tension balance and vascular growth, and play a very important role in cardiovascular diseases, while photo-biological regulation has a protective effect on endothelial cells, and is mainly reflected in the aspects of stimulating cell proliferation, resisting inflammatory apoptosis and the like. In addition, the vascular smooth muscle cells are main components of the arterial wall, and the smooth muscle cells apoptosis induced by the laser with the corresponding wavelength direction is beneficial to reducing the thickening degree of the intima in the repair process of the vascular injury, so that the restenosis after the ablation operation is prevented.
The repairing system integrates the functions of vascular wall repairing and vascular ablation, and improves the safety problem and the effectiveness problem of vascular ablation by single ultraviolet laser in the past; the vascular injury problem after ultraviolet ablation can be repaired by the dual-wavelength laser, and an integral solution of vascular plaque ablation and vascular wall repair by one laser operation is realized by a set of repair system. Through the application of two kinds of lasers in the operation, the ablation efficiency and the safety are improved, the operation risk is reduced to the minimum, the treatment effect is improved by utilizing laser repair, the problem that the vascular wall is not repaired timely after the ablation commonly existing in the vascular operation is solved, the effectiveness and the reliability of the operation are improved, the postoperative complications and the dependence on medicines after the operation are greatly reduced, and the infection rate during the operation and the hidden danger of vascular restenosis are reduced.
Drawings
FIG. 1 is a schematic diagram of a structural system I according to an embodiment 1 of the present invention;
FIG. 2 is a schematic diagram of a structural system II according to embodiment 1 of the present invention;
FIG. 3 is a schematic structural diagram of embodiment 1 of the present invention;
fig. 4 is a schematic structural diagram of a first output member according to embodiment 1 of the present invention;
fig. 5 is a schematic structural diagram of a second output member according to embodiment 1 of the present invention;
FIG. 6 is a schematic view showing the structure of a delivery catheter according to embodiment 1 of the present invention;
FIG. 7 is a schematic view showing the structure of a delivery catheter according to embodiment 2 of the present invention;
wherein, the reference numerals are as follows:
10-a laser generating module; 11-a semiconductor laser; 12-an ultraviolet laser;
20-an output module; 21-a first output member; 211-dispersion optical fiber; 212-a first conduit; 213-first linker; 22-a second output member; 221-quartz bundled optical fiber; 222-luer fitting; 223-second linker;
30-a control module;
40-an alarm module;
50-a power supply module; 51-a first driving power supply; 52-a second driving power supply; 53-switching power supply;
60-delivery catheter, 61-lumen; 61' -a first lumen; 62' -second lumen.
Detailed Description
The wafer alignment device according to the present invention will be described in further detail with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for convenience and clarity in aiding in the description of embodiments of the invention.
In the invention, the outer diameter and the inner diameter correspond to the diameter size for a circular structure, the inner diameter refers to the diameter of an inscribed circle of the circular structure for a non-circular structure, and the outer diameter refers to the diameter of an circumscribed circle of the circular structure; the axial direction corresponds to the direction of the central axis of the cylindrical rod body, and the axial direction corresponds to the length direction of the rod body when the rod body is not cylindrical; the radial direction in the invention is the radial direction when taking the sleeve or the implanted rod as a reference and taking the sleeve as a reference in practice;
in the present invention, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions relative to one another from the perspective of a physician using the product, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to the end of the product that is proximal to the physician during normal operation, and "distal" generally refers to the end that first enters the patient.
In the present invention, the definition of parallel and vertical should not be interpreted as being in a narrow sense as an absolute vertical or an absolute parallel relationship, and should be interpreted as allowing an error of a set angle, typically ±5°, under the corresponding vertical or parallel precondition, the specific value of the set angle being determined according to the required use conditions;
as used in this disclosure, the singular forms "a," "an," and "the" include plural referents, the term "or" are generally used in the sense of comprising "and/or" and the term "several" are generally used in the sense of comprising "at least one," the term "at least two" are generally used in the sense of comprising "two or more," and the term "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying any relative importance or number of features indicated. Thus, a feature defining "a first", "a second", "a third" may include one or at least two such features, either explicitly or implicitly. Furthermore, as used in this disclosure, "mounted," "connected," and "disposed" with respect to another element should be construed broadly to mean generally only that there is a connection, coupling, mating or transmitting relationship between the two elements, and that there may be a direct connection, coupling, mating or transmitting relationship between the two elements or indirectly through intervening elements, and that no spatial relationship between the two elements is to be understood or implied, i.e., that an element may be in any orientation, such as internal, external, above, below, or to one side, of the other element unless the context clearly dictates otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances. Furthermore, directional terms, such as above, below, upper, lower, upward, downward, left, right, etc., are used with respect to the exemplary embodiments as they are shown in the drawings, upward or upward toward the top of the corresponding drawing, downward or downward toward the bottom of the corresponding drawing.
The elastic fiber of the membrane in the blood vessel wall has the function of retracting the dilated blood vessel, and the collagen fiber has the function of maintaining tension and has the supporting function. The amorphous matrix in connective tissue of the vessel wall contains proteoglycans, which vary slightly in composition and water content depending on the type of vessel. Restenosis, as a response to injury to the inner wall of a blood vessel, can be considered, at least in part, as a problem with proliferation or as a special wound healing process. Restenosis is the result of multifactorial effects the primary pathological change is intimal smooth muscle cell proliferation and intimal migration and the creation of large amounts of matrix to cause vascular remodeling that significantly thickens the intima, reduces the lumen and even completely occludes.
Based on the above technical problems, this embodiment provides a vascular repair system, including:
a laser generating module 10 for generating a first laser beam for repairing an inner wall of a blood vessel and a second laser beam for ablating a target tissue in the blood vessel;
an output module 20 for intervention in a blood vessel and for transmitting a first laser light to irradiate the inner wall of the blood vessel with the first laser light for vascular repair; and the laser is also used for transmitting second laser, the second laser irradiates the target tissue in the blood vessel to ablate the target tissue, the wavelength range of the first laser is 600 nm-1064 nm, and the wavelength range of the second laser is 198 nm-400 nm.
The laser generating module 10 generally adopts a conventional laser, the output module 20 is used for delivering laser, and a medium for delivering laser is an optical fiber.
The existing implantation mode can be adopted for the intervention of the output module 20 into the blood vessel, the puncture of the conveying catheter is needed for the existing vascular recanalization minimally invasive operation to build a conveying system, the common clinic generally uses the modes of femoral artery puncture and radial artery puncture, firstly, a guide wire and the conveying catheter are required to be inserted, the conveying catheter is driven by the guide wire to finally reach the target blood vessel along the arterial access, and the output module 20 reaches a guiding position through the conveying system built by the conveying catheter;
the laser with a certain wavelength range irradiates human tissues, can cause mitochondria to generate biological photochemical action, and can increase the activity of catalase of the mitochondria. Thus, it can increase metabolism of cells, increase glycogen content, increase protein synthesis and adenosine triphosphate decomposition, so that it can promote cell synthesis, promote healing of wound and ulcer, promote healing of fracture, accelerate regeneration of damaged nerve, and increase phagocytosis of white blood cells. Meanwhile, the special photosensitive dressing is matched, and the composition can also be used for treating acne. Red light or near infrared light can stimulate the ATP growth of human body, and cytochrome C oxidase absorbs light, so that the fluorescent dye can promote vascular injury repair, enhance the function of immune defense system, promote metabolism, reduce blood viscosity, regulate blood fat, accelerate the removal of inflammatory mediators, promote the absorption of tissue edema and the like.
In the natural repair process of the inner wall of the blood vessel, the secretion of the vascular cell adhesion molecules-1 and the intercellular adhesion molecules-1 is increased, and the leucocytes migrate and adhere to the endothelial injury under the mediation of various chemotactic factors, so that the leucocytes gather under the endothelium, and the local chronic inflammatory reaction of the blood vessel is triggered by the inflammatory mediators secreted by the leucocytes, so that plaque formation is mediated. The present study shows that the red light or near infrared light with high and low energy density is used for irradiating the inner wall of the blood vessel, and the light biological regulation effect is mainly utilized, so that the energy density of the first laser generated by the laser generating module 10 is adjustable, and the low energy density promotes the vascular endothelial cell proliferation and anti-inflammatory apoptosis. Vascular smooth muscle cells are the main component of the arterial wall, and red light or near infrared light induced smooth muscle cell apoptosis with high energy density is beneficial to reducing the thickening degree of an intima after angioplasty so as to prevent restenosis after ablation; these effects may be related to the following mechanisms: affecting intracellular calcium ion flow, promoting NO release, and stabilizing and activating mitochondria.
The wavelength of the first laser is 600 nm-1064 nm, which has good effect on vascular repair and restenosis prevention, preferably 635nm or 810nm, the output average power is 200 mW, and the energy density is 0.2-5J/cm 2 Wherein the low energy density is generally 0.2 to 1J/cm 2 The high and low energy density is generally 1-3J/cm 2 The first laser may be output continuously or pulsed.
The invention further enables the laser light generation module 10 to be used for generating a second laser light; wherein the laser generating module 10 includes a semiconductor laser 11 for generating a first laser light and an ultraviolet laser 12 for generating a second laser light, the ultraviolet laser 12 being provided on the semiconductor laser 11.
The semiconductor laser 11 can be selected from KD type multi-wavelength pluggable semiconductor laser, the energy density of red light or near infrared light generated by the semiconductor laser 11 can be adjusted, and the low energy density range is preferably 0.2-1J/cm 2 Vascular repair can be performed by low energy promotion of vascular endothelial cell proliferation to reduce inflammatory response, or by more than 1J/cm 2 The high energy of (2) inhibits smooth muscle cell proliferation and inhibits plaque reformation, wherein specific values of low energy density and high energy density can be adaptively adjusted according to individual differences.
The ultraviolet laser 12 can be a Gama type high-frequency ultraviolet pulse laser, the wavelength range generated by the ultraviolet laser is 198-400 nm, an ultraviolet high-repetition frequency pulse laser with 355nm wavelength is preferred, the laser is a solid ultraviolet laser, the single pulse energy can reach 125mj, the pulse width is 10ns, the repetition frequency is 100Hz, the step is adjustable, the repeated frequency is high, the effect is achieved on different types of plaques, the noise is relatively low, the preheating time is short, the ultraviolet lasers in the model series can output multiple wavelength lasers through a switching frequency multiplication module, and the free switching of the lasers with different wavelengths can be realized.
For the application of the second laser, the ultraviolet high-energy laser with nanosecond pulse width is led into the vascular cavity by utilizing an optical fiber, so that the ultraviolet high-energy laser directly acts on the narrow occlusion, and the target tissue at the narrow occlusion is crushed into micron-sized particles for ablation by means of multiple effects such as photochemistry, photo-thermal and photo-mechanical, so that the volume reduction and the lumen expansion are realized, and the effect of minimally invasive treatment is realized. This example uses 355nm frequency-tripled Nd: the YAG solid laser source has short laser pulse width, can obtain higher peak power with smaller laser energy, and can effectively ablate plaque target tissues; at the same time, the thermal effect is small, and the risk of vascular perforation is reduced.
The device has simple structure, is easy to operate, and can debug out the adaptive output laser parameters according to the treatment of different cavity diseases.
Wherein the first laser light may be generated after the second laser light such that the first laser light is used to irradiate the inner wall of the ablated vessel.
In order to improve the efficiency of laser ablation of target tissues and the capability of completely calcified plaque, the energy of the second laser is improved as much as possible, but the risk brought by improving the laser energy is that the probability of damaging the inner wall of a blood vessel is increased, and thus, the restenosis of the blood vessel is brought with great hidden trouble. Therefore, although the laser operation device is widely applied to a plurality of clinics at present, the defects of single curative effect, low precision and large damage exist, and the application of the laser operation device in high-precision operation is limited.
In general, the principle of treatment of main artery vascular injury after laser ablation surgery is mainly to restore the continuity of arteries, and the earlier and better repair of the damaged arteries is preferably performed immediately after ablation, and the time delay greatly increases the chance of intravascular thrombosis or infection, thereby reducing the possibility of restoring blood circulation; in the embodiment, the treatment principle of main arterial vessel injury after operation can be just satisfied due to the functions of repairing the inner wall of the vessel and ablating and recanalizing the vessel; the vascular repair function in the system can carry out irradiation repair on the inner wall position of the blood vessel after ablation, solves the contradiction between laser energy and laser efficiency, improves the curative effect of minimally invasive surgery and is beneficial to expanding the application field of laser surgery.
For example, after target tissue is removed by using 355nm wavelength second laser ablation, 635nm or 810nm wavelength first laser can be introduced into the inner wall of the blood vessel, and irradiation repair treatment is performed on the position on the inner wall of the blood vessel after the target tissue is ablated, so that the vascular repair and the ablation function of the target tissue are complementary, the problem of contradiction between the ablation efficiency and the damage of the inner wall of the blood vessel in the ablation process is solved, the laser ablation operation effect is improved, and the application range of the laser operation is widened.
In addition, in other alternative embodiments, the first laser may be used alone, and the first laser may irradiate the inner wall of the blood vessel early in the disease. The first laser irradiation can prevent thrombosis in the initial stage, reduce vasoconstriction active substances, promote vasoconstriction active substances, reduce venous thrombosis in blood, and is beneficial to preventing cardiovascular and cerebrovascular thrombosis diseases such as cerebral apoplexy, cerebral infarction, myocardial infarction, coronary heart disease, etc.
In the embodiment, the functions of vascular wall repair and vascular ablation are integrated in the vascular repair system, and the vascular repair system is actually a dual-wavelength laser plaque ablation combined vascular wall repair system, and the multifunctional vascular repair system improves the safety problem and the effectiveness problem of vascular ablation by single ultraviolet laser in the past; the vascular injury problem after ultraviolet ablation can be repaired by the dual-wavelength laser, and an integral solution of vascular plaque ablation and vascular wall repair by one laser operation is realized by a set of repair system. Through the application of two kinds of lasers in the operation, the ablation efficiency and the safety are improved, the operation risk is reduced to the minimum, the treatment effect is improved by utilizing laser repair, the problem that the vascular wall is not repaired timely after the ablation commonly existing in the vascular operation is solved, the effectiveness and the reliability of the operation are improved, the postoperative complications and the dependence on medicines after the operation are greatly reduced, and the infection rate during the operation and the hidden danger of vascular restenosis are reduced.
Further, the output module 20 includes a first output member 21 and a second output member 22, the first output member 21 being configured to transmit a first laser light and irradiate the first laser light to an inner wall of a blood vessel for vascular repair, the second output member 22 being configured to transmit a second laser light and irradiate the second laser light to a target tissue in the blood vessel to ablate the target tissue; the first output member 21 and the second output member 22 are optical fibers.
The first laser has extremely strong biological tissue penetrability in a narrow spectrum, the first laser is directly transmitted into a blood vessel through the first output piece 21, the first output piece 21 can be a dispersion optical fiber, a bundling optical fiber and a lateral output optical fiber, and the head of the first output piece 21 is preferably a dispersion optical fiber after special treatment so that the first laser uniformly irradiates on the inner wall of the blood vessel.
Referring to fig. 4, the first output element 21 includes a dispersion fiber 211, a first catheter 212, and a first connector 213, where a proximal end of the dispersion fiber is located in the first catheter 212, the proximal end of the first catheter 212 is connected to the first connector 213, and the proximal end of the dispersion fiber is connected to the first connector 213, the first connector 213 is used to connect to the semiconductor laser 11, so that a first laser generated in the semiconductor laser 11 enters the dispersion fiber and is transmitted, a distal end of the dispersion fiber is a dispersion end, and the first laser emits light through a distal end of the dispersion fiber in a dispersion manner, so that the first laser irradiates on an inner wall of a blood vessel uniformly.
The second output piece 22 is an ultraviolet laser fiber bundle, and the ultraviolet laser fiber bundle enters the blood vessel for treatment through the catheter; the second output member 22 is preferably a quartz bundle optical fiber, the quartz bundle optical fiber is fastened together by a plurality of optical fibers, please refer to fig. 5, the second output member 22 includes a quartz bundle optical fiber 221, a luer connector 222 and a second connector 223, wherein the quartz bundle optical fiber 221 is connected with the luer connector 222 and the second connector 223, the luer connector 222 can inject saline through a syringe, the saline is used for cooling, reducing thermal effect, and also can be used for cleaning a treatment surface, wherein the second connector 223 is connected with the ultraviolet laser 12; the second output member 22 may be purchased from existing equipment, for example, the second output member 22 may be of the UVLC type, the second output member 22 is a laser ablation catheter having a nominal outer diameter of 1.54mm and a nominal length of 3m, a tensile strength of 10N, a minimum bend radius of 500mm, and the second output member 22 is sterilized with ethylene oxide.
The structures of the first joint and the second joint can adopt the existing joint structures, the semiconductor laser 11 and the ultraviolet laser 12 are purchased by the existing equipment, and the connection mode of the first joint and the semiconductor laser 11 and the connection mode of the second joint and the ultraviolet laser 12 are both the prior art and are not repeated here;
the first output piece 21 and the second output piece 22 can enter the blood vessel of the human body through the sheath tube by the guide wire on the conveying catheter, and the conveying catheter reaches the lesion part along the guide wire;
in this embodiment, the first output member 21 and the second output member 22 are in a split structure, so that in the ablation procedure, the first output member 21 and the second output member 22 enter the blood vessel in sequence, the second output member 22 is conveyed to the vicinity of the target tissue through the blood vessel first, ablation is started, and after the ablation is finished, the second output member 22 is controlled to withdraw the corresponding catheter and withdraw from the blood vessel of the human body; after being retracted, the first output piece 21 is conveyed into the blood vessel for irradiation after ablation so as to repair the wall of the blood vessel; in another alternative embodiment, the first output member 21 and the second output member 22 may be integrated, both delivered simultaneously to the interior of the blood vessel, and selectively generate either the first laser light or the second laser light based on the needs of the procedure.
Further, the vascular repair system further comprises a control module 30, and the control module 30 is in communication connection with the laser generation module 10 and is used for controlling an emergent mode of the laser generation module 10, wherein the emergent mode at least comprises a first laser emergent mode alone, a second laser emergent mode alone and a first laser and second laser emergent mode simultaneously.
The vascular repair system further comprises a power supply module 50, the power supply module 50 being adapted to power the laser generating module 10 and the control module 30.
Referring to fig. 2, the control module 30 is communicatively connected to the semiconductor laser 11 and the ultraviolet laser 12;
the power supply module 50 comprises a first driving power supply 51, a second driving power supply 52 and a switching power supply 53, wherein the first driving power supply 51 is electrically connected with the semiconductor laser 11 and is used for supplying power to the semiconductor laser 11, the second driving power supply 52 is electrically connected with the ultraviolet laser 12 and is used for supplying power to the ultraviolet laser 12, the switching power supply 53 is electrically connected with the control module 30 and is used for supplying power to the switching power supply 53, the first output piece 21 is connected with the semiconductor laser 11, and the second output piece 22 is connected with the ultraviolet laser 12; wherein the first driving power source 51 and the second driving power source 52 may be pulse width modulated IGBT chopper power sources.
The control module 30 preferably adopts a dual wavelength control system, the control module 30 can adopt a PLC or a singlechip, please refer to FIG. 3, the control module 30 comprises a main control board, an LCD operation screen, a preparation/emission indicator lamp, a foot switch, a water flow switch and a water temperature sensor, wherein the foot switch is connected with the main control board for starting and closing the control module 30, the water flow switch is connected with the main control board for controlling the starting and closing of the cooling system and the cooling flow, the water temperature sensor is connected with the main control board, the water temperature sensor is used for acquiring the water temperature information at the designated position of the cooling system and transmitting the water temperature information to the main control board, the water temperature information is displayed on the LCD operation screen, the LCD operation screen is connected with the main control board in a communication way, the LCD operation panel is used for displaying related information, such as water temperature information of a cooling system, on information of the semiconductor laser 11 and the ultraviolet laser 12, current of the power supply module 50, information of output time length, and the like, and is also used for outputting operation instructions for controlling the power supply module 50 and the laser generating module 10, for example, the LCD operation panel can be used for inputting current magnitude and output time length parameters of the first driving power supply 51 or the second driving power supply 52, and for example, the LCD operation panel can be used for controlling and switching light emitting modes and treatment time of different lasers, and can also be used for controlling parameters such as energy density, pulse width, heavy frequency and the like of laser emission to control the efficiency of intravascular ablation; the preparation/emission indicator lamp is used for displaying the laser emission state, and when the preparation/emission indicator lamp is lighted, the preparation/emission indicator lamp represents that the laser is ready to emit or is emitting;
referring to fig. 3, a first driving power supply 51 and a second driving power supply 52 are integrated in the laser power supply in fig. 3, the red light laser in fig. 3 is the semiconductor laser 11, the ultraviolet laser is the ultraviolet laser 12, the laser power supply is in communication connection with the main control board, the first driving power supply 51 in the laser power supply is electrically connected with the red light laser, the second driving power supply 52 in the laser power supply is electrically connected with the ultraviolet laser, and the active board is in communication connection with the ultraviolet laser and the red light laser;
referring to fig. 3, the vascular repair system of the present embodiment further includes a cooling system, an emergency stop switch, a key switch, and an air switch, where the cooling system is connected to the red laser and the ultraviolet laser, and is used to provide cooling liquid for the two lasers, and the cooling system is further electrically connected to the switching power supply 53; the emergency stop switch is electrically connected with the laser power supply and the switching power supply 53 and is used for emergently disconnecting the laser power supply and the switching power supply 53 so as to emergently stop; the air switch is connected with the key switch, and the key switch is connected with the emergency switch;
with continued reference to fig. 3, in order to better improve the light-emitting effect, in this embodiment, an optical module, such as an optical fiber coupling device, is further provided, and the optical performance of the laser is improved by the optical module;
the optical module may further include a beam combining device for combining the aiming light with the second laser beam and a PBS attenuation device; the PBS attenuation device consists of a half-wave plate, PBS and a beam terminator, and the laser energy coupled into the optical fiber can be controlled by rotating the half-wave plate; the coupling device consists of a DOE homogenizing sheet and a coupling lens, and is used for homogenizing laser and then coupling the laser into an optical fiber through the coupling lens.
Wherein the control module 30 controls the first driving power supply 51 and the second driving power supply 52 simultaneously or in a time-sharing manner, thereby driving the semiconductor laser 11 and the ultraviolet laser 12 to emit laser light; the control mode has a first laser single light emitting mode, a second laser single light emitting mode and a first laser second laser simultaneous light emitting mode, wherein the first laser single light emitting mode is that the semiconductor laser 11 singly emits first laser, at the moment, the first laser single light emitting mode is that the ultraviolet laser 12 singly emits second laser, at the moment, the second laser single light emitting mode is that the semiconductor laser 11 and the ultraviolet laser 12 simultaneously generate corresponding laser, at the moment, the first laser and the second laser simultaneously output and act on a target position.
Preferably, the control module controls the start of the first laser single light emitting mode to be after the start of the second laser single light emitting mode, that is, after the first laser is generated after the second laser, and then the first laser is generated after the second laser is generated for vascular ablation recanalization, so that the first laser is generated for repairing the inner wall at the vascular ablation site.
The vascular repair system further comprises a delivery catheter 60, the delivery catheter 60 being for implantation into the blood vessel to form a delivery channel, the delivery catheter 60 having one lumen for introducing the first output member 21 or the second output member 22 into the blood vessel through the lumen, or having two lumens for introducing the first output member 21 and the second output member 22 into the blood vessel through both of the lumens simultaneously.
Referring to fig. 6, the delivery catheter 60 has a lumen 61 for introducing only a single instrument at a time, so that the first output member 21 and the second output member 22 have a sequential order of introduction, for example, the second output member 22 is introduced, the second output member 22 is removed after the operation is completed, and the first output member 21 is introduced;
referring to fig. 7, the delivery catheter 60 has two lumens, a first lumen 61 'and a second lumen 62', respectively, so that the first output member 21 can be introduced through the first lumen 61 'and the second output member 22 can be introduced through the second lumen 62', and thus, the first output member 21 and the second output member 22 can be introduced at the target site at the same time, and then the first laser light and the second laser light can be simultaneously applied at the target site;
the vascular repair system further comprises a blood pressure acquisition unit and an alarm module 40, wherein the blood pressure acquisition unit and the alarm module 40 are both in communication connection with the control module 30; the control module 30 is further configured to: and receiving the blood pressure value of the intervened blood vessel acquired by the blood pressure acquisition unit, judging whether the blood pressure value is smaller than a set value, and controlling the alarm module 40 to give an alarm if the blood pressure value is smaller than the set value.
The alarm module 40 is in communication or electrically connected with the control module 30, the alarm module 40 may be integrated on the laser generating module 10 or integrated in the control module 30, the alarm module 40 being configured to issue a warning, for example, by audio tones, visual signals, tactile feedback and/or controlling the shutdown of the laser generating module 10 to form an audible/visual alarm or other warning; for example, the alarm module 40 may be an alarm lamp, and the alarm module 40 may flash to alarm through the alarm lamp, or the alarm module 40 may be a buzzer, and the alarm module 40 may also be a warning mark integrated on a display interface of an LCD operation screen through sounding to alarm;
the blood pressure acquisition unit is a pressure sensor, for example, a FOP type optical fiber pressure sensor is adopted, the sensor is widely applied to cardiovascular department, the application of the sensor is the prior art, and the description is omitted here; the pressure sensor may be integrated on the first output member 21 and the second output member 22 and delivered to the blood vessel to be intervened in the blood vessel as the first output member 21 and the second output member 22 are delivered to detect the blood pressure of the blood vessel, or the pressure sensor may be integrated on the delivery catheter and delivered to the blood vessel to be intervened in the blood vessel as the delivery catheter is delivered to detect the blood pressure of the blood vessel; the pressure sensor is in communication connection with the control module, so as to send the acquired blood pressure value to the control module for comparison with a set value, so as to avoid clinical risks, for example, if the pressure sensing threshold of the carotid sinus is 0.08-0.24atm, which is far smaller than the standard working pressure of a clinically used balloon, the alarm module 40 alarms, because the balloon is required to slowly increase and slowly release pressure in the expanding process, but the risk of hypotension and cerebral ischemia in operation exists, the set value of the blood pressure is obtained according to the pressure safety boundary, and the clinical safety is ensured by the alarm module 40.
The device solves the problems of bleeding after ablation and untimely vascular wall repair which are commonly existed in vascular surgery, improves the effectiveness of the surgery, greatly reduces complications and dependence on medicines, can adjust laser parameters emitted by the semiconductor laser 11 and the ultraviolet laser 12 through the control module 30, is beneficial to minimizing the risk of the surgery according to actual operation conditions, and reduces the infection rate in the surgery and after the surgery by repairing the blood vessel by using second laser.
In addition, the present embodiment also provides a control method of the vascular repair system, which controls the laser generating module 10 to start through the control module 30, and outputs a first laser for vascular repair and/or a second laser for ablation of target tissue in the blood vessel; and/or the number of the groups of groups,
and controlling the second laser to be independently output into the blood vessel, and controlling the first laser to be independently output into the blood vessel after delaying for a preset time.
The delay preset time can be set through the control module, or can be manually determined according to an actual site of an actual operation, wherein the first laser and the second laser can be independently output for use, or the first laser and the second laser can be mutually matched for use, one mode is that the first laser and the second laser are simultaneously output for irradiation, the other mode is that the first laser and the second laser are sequentially output, and the second laser is positioned behind the first laser; since the first laser is generated by the semiconductor laser 11 and the second laser is generated by the ultraviolet laser 12, the starting sequence of the semiconductor laser 11 and the ultraviolet laser 12 can be manually controlled by a human so as to control the delay preset time, and the output mode and the output sequence of the first laser and the second laser can be controlled by a control module;
for example, in the same operation, the ultraviolet laser 12 is controlled to emit the second laser light, the second laser light is used for intravascular ablation through the second output piece 22, then the semiconductor laser 11 is controlled to emit the first laser light, the first laser light is used for vascular wall repair after ablation through the first output piece 21, the functions of intravascular plaque ablation and vascular wall repair after ablation are respectively realized through time-sharing control of the control module 30 in action time, or only the semiconductor laser 11 is controlled to emit the first laser light, and the first laser light is used for vascular wall repair through the first output piece 21.
The control method further comprises the steps of collecting blood pressure values in blood vessels and judging the sizes of the blood pressure values relative to a set value; and if the blood pressure value is greater than or equal to the set value, controlling the laser generating module 10 to generate the first laser and/or the second laser.
Specifically, the pressure sensor integrated on the first output piece, the second output piece or the conveying catheter is used for acquiring the blood pressure value of the blood vessel, the pressure sensor transmits the acquired blood pressure value to the control module for comparison with a set value, and if the blood pressure value is greater than or equal to the set value, the laser generating module 10 is controlled to generate the first laser and/or the second laser; in the real-time detection process, if the blood pressure value is smaller than the set value, the blood pressure value is indicated not to be suitable for the operation environment, and the laser generating module 10 is turned off to stop generating laser.
In summary, the vascular repair system provided in the present invention includes:
the laser generation module is used for generating first laser and second laser, and the wavelength range of the first laser is 600 nm-1064 nm;
and the output module is used for being implanted into a blood vessel, transmitting the first laser for repairing the inner wall of the blood vessel and transmitting the second laser for ablating target tissues in the blood vessel.
So configured, the output module 20 irradiates the inner wall of the blood vessel with laser light in a certain wavelength range, mainly using the photo-biological regulation function, and the vascular smooth muscle cells are the main components of the arterial wall, and the laser-induced smooth muscle cells apoptosis in the corresponding wavelength direction is beneficial to reducing the thickening degree of the intima after the angioplasty so as to prevent and treat restenosis after the ablation;
the repairing system integrates the functions of vascular wall repairing and vascular ablation, and improves the safety problem and the effectiveness problem of vascular ablation by single ultraviolet laser in the past; the vascular injury problem after ultraviolet ablation can be repaired by the dual-wavelength laser, and an integral solution of vascular plaque ablation and vascular wall repair by one laser operation is realized by a set of repair system. Through the application of two kinds of lasers in the operation, the ablation efficiency and the safety are improved, the operation risk is reduced to the minimum, the treatment effect is improved by utilizing laser repair, the problem that the vascular wall is not repaired timely after the ablation commonly existing in the vascular operation is solved, the effectiveness and the reliability of the operation are improved, the postoperative complications and the dependence on medicines after the operation are greatly reduced, and the infection rate during the operation and the hidden danger of vascular restenosis are reduced.
In the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different point from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other.
The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the appended claims.
Claims (13)
1. A vascular repair system, comprising:
the laser generation module is used for generating first laser for repairing the inner wall of the blood vessel and second laser for ablating target tissues in the blood vessel, and the wavelength range of the first laser is 600 nm-1064 nm;
and the output module is used for being intervened in a blood vessel and transmitting the first laser and the second laser.
2. The vascular repair system of claim 1, wherein an energy density of the first laser light generated by the laser light generation module is adjustable.
3. The vascular repair system of claim 1, wherein the second laser has a wavelength in the range of 198nm to 400nm.
4. The vascular repair system of claim 1, wherein the output module includes a first output for transmitting the first laser light and causing the first laser light to impinge on an inner wall of the blood vessel and a second output for transmitting the second laser light and causing the second laser light to impinge on target tissue within the blood vessel.
5. The vascular repair system of claim 4, further comprising a delivery catheter for implantation within the vessel to form a delivery channel, the delivery catheter having a lumen for introducing the first delivery member or the second delivery member into the vessel through the lumen; alternatively, the delivery catheter has two lumens for simultaneously introducing the first and second delivery members into the vessel through the two lumens, respectively.
6. The vascular repair system of claim 4, wherein the first output member is a dispersion fiber, a bundling fiber, or a lateral output fiber; and/or, the second output piece is a bundled optical fiber.
7. The vascular repair system of claim 1, wherein the laser generation module includes a semiconductor laser for generating the first laser light and an ultraviolet laser for generating the second laser light.
8. The vascular repair system of claim 1, further comprising a control module communicatively coupled to the laser generation module for controlling an exit mode of the laser generation module, the exit mode including at least a first laser individual exit mode, a second laser individual exit mode, and a first laser second laser simultaneous exit mode.
9. The vascular repair system of claim 8, wherein the control module is further configured to: and controlling the starting of the first laser single light emitting mode to be after the starting of the second laser single light emitting mode.
10. The vascular repair system of claim 8, further comprising a power module for powering the laser generation module and the control module.
11. The vascular repair system of claim 8, further comprising a blood pressure acquisition unit and an alarm module, each in communication with the control module, the control module further configured to: and receiving the blood pressure value of the intervened blood vessel acquired by the blood pressure acquisition unit, judging whether the blood pressure value is smaller than a set value, and controlling the alarm module to give an alarm if the blood pressure value is smaller than the set value.
12. A control method of a vascular repair system is characterized in that,
controlling the laser generation module to start and outputting a first laser for vascular repair and/or a second laser for ablation of target tissue in a blood vessel; and/or the number of the groups of groups,
and controlling the second laser to be independently output into the blood vessel, and controlling the first laser to be independently output into the blood vessel after delaying for a preset time.
13. The control method according to claim 12, wherein,
collecting blood pressure values in blood vessels, and judging the sizes of the blood pressure values relative to a set value;
and if the blood pressure value is greater than or equal to the set value, controlling the laser generating module to generate the first laser and/or the second laser.
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| CN202210869431.6A CN117462241A (en) | 2022-07-22 | 2022-07-22 | Vascular repair system and control method |
| PCT/CN2023/108114 WO2024017288A1 (en) | 2022-07-22 | 2023-07-19 | Vascular repair system and control method |
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| CN202210869431.6A CN117462241A (en) | 2022-07-22 | 2022-07-22 | Vascular repair system and control method |
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