Degradable drug coating tectorial membrane balloon catheter and application method thereofTechnical Field
The invention relates to the technology of medical instruments, in particular to a degradable drug coating tectorial membrane balloon catheter and a use method thereof.
Background
Coronary aneurysms are a relatively rare type of cardiovascular disease, but have potential fatal risks, including thrombosis, massive hemorrhage caused by tumor body rupture, coronary interruption caused by tumor body pressure, and the treatment of coronary aneurysms, which can only be resected by surgical operation in the cardiovascular field at present;
Coronary artery perforation in coronary artery operation is a serious complication, and can lead to acute pericardial packing and death, and common reasons include that when a guide wire is perforated and a balloon is expanded, the blood vessel is broken due to hidden calcification in the blood vessel or improper balloon selection or excessive pressure, and the blood vessel is broken due to stent expansion;
The treatment mode in the prior art is as follows:
1. the common pre-expanded saccule is placed at the coronary artery rupture site to be expanded for blocking, so that the rupture site can be blocked with a certain probability;
however, if the treated blood vessel is originally smooth and only has partial stenosis, the balloon is used for blocking, and the balloon can cause blood interruption at the moment to cause ischemia symptoms, heart failure or malignant arrhythmia, and when the through balloon catheter is used for treatment, the prepared through balloon catheter model is not necessarily matched with the size of the rupture of the ruptured blood vessel;
2. after the test plugging of the common pre-expanded saccule is successful, the break is small, but blood outflow still exists, and at the moment, a double-layer bracket is often adopted for secondary plugging;
However, the problems of difficult delivery of the second layer stent and difficult endothelialization of the double layer stent, and the need for combination therapy with two antiplatelet drugs for life;
3. The stent is stuck to seal the breach, but the stent is expensive and has the problem of difficult endothelialization in later period, and the prior art reports that after the problem is treated by using the stent product which is already marketed, the restenosis rate in the stent is obviously increased within ten years of patients, so that the patients receive coronary artery operation again and face the risks of heart failure, arrhythmia and recurrent myocardial infarction;
The 3M transfusion film is wound on the middle section of the bracket to self-prepare the film-covered bracket, but the winding position, the winding number and the winding force of the 3M transfusion film are completely based on individual experience, so that the future health condition or disease development trend of patients can not be clearly assessed, endothelialization can not be realized, and the combination therapy of two antiplatelet medicines is required for the whole life.
Disclosure of Invention
The invention aims to provide a degradable drug coating tectorial membrane balloon catheter and a use method thereof, which are used for solving the defect that the aneurysm is positioned at a vascular position and is difficult to stop bleeding when in coronary aneurysm operation in the prior art.
In order to achieve the purpose, the invention provides the technical scheme that the degradable drug coating tectorial membrane balloon catheter comprises a Y-shaped connecting valve, wherein a guide catheter is arranged at the connecting end of the Y-shaped connecting valve, and the degradable drug coating tectorial membrane balloon catheter further comprises:
the double-cavity balloon catheter is movably arranged on the inner side of the guide catheter and can extend to the outer side of the guide catheter, and a guide wire cavity and an expansion cavity are arranged on the inner side of the double-cavity balloon catheter;
the guide wire is movably arranged at the inner side of a guide wire cavity formed in the double-cavity balloon catheter, and can extend to the outer side of the double-cavity balloon catheter;
the balloon component is arranged at the tail end of the double-cavity balloon catheter, and the outer side of the balloon component is coated with a drug covering film.
Further, the balloon assembly includes:
the balloon is fixedly arranged at the tail end of the double-cavity balloon catheter, the inner cavity of the balloon is communicated with the expansion cavity of the double-cavity balloon catheter, the outer side of the balloon is coated with a drug covering film, and the drug covering film is connected with the outer side of the balloon.
Further the medicine covering film comprises a covering film and a medicine coating layer coated on the outer side of the covering film.
Further, the covering film is formed by compounding carboxymethyl chitosan and low-molecular-weight polylactic acid-glycolic acid copolymer.
Further, the drug of the drug coating is rapamycin.
The method for using the degradable medicine coating film covered balloon catheter is suitable for the degradable medicine coating film covered balloon catheter, and is used for using the degradable medicine coating film covered balloon catheter and comprises the following steps of:
S1, preparing a Y-shaped connecting valve, a guide catheter, a guide wire and a double-cavity balloon catheter, ensuring that the parts of the Y-shaped connecting valve, the guide catheter, the guide wire, the balloon coated with a drug covering film on the double-cavity balloon catheter and the like are intact, and ensuring that all connecting parts are firm and reliable;
s2, sterilizing the Y-shaped connecting valve, the guide catheter, the guide wire and the double-cavity balloon catheter, ensuring sterile operation, and checking whether a drug coating on the drug covering film is uniform and complete;
S3, carrying out anesthesia treatment on the patient, and leading the patient to take proper body position for guiding catheter insertion and operation;
inserting a guide wire into a guide wire cavity of the double-cavity balloon catheter through the Y-shaped connecting valve until the guide wire extends to the outer side of the double-cavity balloon catheter and reaches a target position;
under the guidance of the guide wire, the double-cavity balloon catheter is inserted into the body along the guide catheter until reaching the preset treatment position;
S4, injecting a proper amount of liquid into the balloon through the expansion cavity of the double-cavity balloon catheter, so that the balloon assembly is expanded and clings to the vessel wall or the treatment area, pre-expanding is carried out on the vascular lesion position, meanwhile, the medicine covering film coated on the outer side of the balloon is adhered to the inner wall of the vessel, and the medicine of the medicine covering film begins to be released and acts on the treatment part;
S5, extracting liquid in the balloon assembly through the expansion cavity of the double-cavity balloon catheter, retracting the balloon assembly and restoring the balloon assembly, adhering and staying on the inner wall of the blood vessel by the drug covering film to ensure that the drug is fully released and acts, and withdrawing the guide wire, the double-cavity balloon catheter and the guide catheter from the patient.
Compared with the prior art, the degradable drug coating covered balloon catheter and the application method thereof have the advantages that for coronary rupture in coronary intervention operation, the drug coating can be adhered to the coronary rupture by means of balloon opening, so that the coronary rupture is blocked, blood in the coronary can not enter the tumor, the time for interrupting coronary blood flow is reduced, the risk caused by coronary interruption is avoided, serious complications such as ventricular tachycardia and ventricular fibrillation are prevented, meanwhile, the risk of secondary coronary tumor formation possibly left after operation is completely blocked, health of a patient is further ensured, for coronary tumor, the drug coating can be adhered to the opening of the inner side of an aneurysm, the drug coating can completely cover the opening of the inner side of the blood vessel, so that blood flow in the coronary cannot enter the tumor, the blood in the coronary stops flowing and solidifies, the tumor can not grow any more, the coronary intervention rupture is prevented, in detail, the risk of coronary rupture caused by coronary intervention operation, the coronary vascular flow can be prevented from being seriously damaged by the coronary rupture, the coronary rupture is prevented from being seriously, and the time for coronary intervention operation is not required, the coronary rupture is prolonged, and the coronary injury caused by the coronary rupture is prevented, and the coronary rupture is prevented from being seriously, and the coronary rupture is prevented from being expanded, and the coronary injury is prevented. Furthermore, the tectorial membrane of tectorial membrane sacculus has degradable performance, and degradation product is nontoxic to the human body, and degradation time is within 1-3 months and the tectorial membrane thickness is very thin, does not influence the endothelialization of follow-up implantation support and the wall problem of support adherence, simultaneously also can reduce the risk that the tumor body breaks, adopts intervention to coronary aneurysm, avoids the operation of opening, and need not to use the support, has realized that the vascular wall fuses better, reduces rejection and the risk of thrombosis to improve treatment effect and patient's quality of life, and then need not to worry the restenosis that the tectorial membrane support brought, realizes keeping vascular patency for a long time, this helps reducing patient's retreatment rate and complication incidence, improves patient's quality of life and prognosis.
Drawings
In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for the embodiments will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments described in the present application, and other drawings may be obtained according to these drawings for a person having ordinary skill in the art.
FIG. 1 is a schematic diagram of an overall structure according to an embodiment of the present invention;
Fig. 2 is an enlarged view of a in fig. 1 provided in an embodiment of the present invention.
Reference numerals illustrate:
1. y-shaped connecting valve, 2, guiding catheter, 3, double-cavity balloon catheter, 4, guide wire, 5, balloon and 6, medicine covering film.
Detailed Description
In order to make the technical scheme of the present invention better understood by those skilled in the art, the present invention will be further described in detail with reference to the accompanying drawings.
Embodiment one:
referring to fig. 1 and 2, a degradable drug coating tectorial membrane balloon catheter, which comprises a Y-shaped connecting valve 1, wherein a guiding catheter 2 is arranged at the connecting end of the Y-shaped connecting valve 1, and is characterized by further comprising:
The double-cavity balloon catheter 3 is movably arranged on the inner side of the guide catheter 2 and can extend to the outer side of the guide catheter 2, and a guide wire cavity and an expansion cavity are arranged on the inner side of the double-cavity balloon catheter 3;
The guide wire 4 is movably arranged at the inner side of a guide wire cavity formed in the double-cavity balloon catheter 3, and the guide wire 4 can extend to the outer side of the double-cavity balloon catheter 3;
the balloon component is arranged at the tail end of the double-cavity balloon catheter 3, and the outer side of the balloon component is coated with a drug covering film 6.
The Y-shaped connecting valve 1 is used for guiding, placing and locking the guiding catheter 2 and the guide wire 4, the Y-shaped connecting valve 1 and the guiding catheter 2 are connected through a catheter connector, the connection modes include, but are not limited to, rotation, screwing or pressing, the connection modes comprise firmness and tightness of the connection, the double-cavity balloon catheter 3 is provided with double cavities, the double-cavity balloon catheter comprises a guide wire cavity and an expansion cavity, the guide wire cavity is used for guiding a moving path of the guide wire 4, the expansion cavity is used for flushing and releasing liquid to the balloon assembly, and the drug covering membrane 6 can be adhered to the inner wall of a blood vessel wall.
The balloon assembly includes:
The balloon 5 is fixedly arranged at the tail end of the double-cavity balloon catheter 3, the inner cavity of the balloon 5 is communicated with the expansion cavity of the double-cavity balloon catheter 3, the outer side of the balloon 5 is coated with the drug covering film 6, and the drug covering film 6 is connected with the outer side of the balloon 5.
The specific implementation mode is that the balloon 5 is a medical expansion balloon, the balloon 5 is communicated with an expansion cavity of the double-cavity balloon catheter 3, liquid is injected into the expansion cavity of the double-cavity balloon catheter 3, the liquid comprises but is not limited to contrast agent, the balloon 5 is inflated, the drug covering film 6 is unfolded and covered on the wall of the blood vessel while the blood vessel is expanded, and is adhered to the wall of the blood vessel, when the balloon 5 is contracted, the drug covering film 6 is separated from the balloon 5, and the drug covering film 6 can cover a coronary artery tumor rupture position, so that blood in the blood vessel does not enter a tumor body any more, and spontaneous thrombus formation in the tumor body is promoted.
The medicine cover film 6 includes a cover film and a medicine coating layer applied to the outside of the cover film.
The covering film is formed by compounding carboxymethyl chitosan and low molecular weight polylactic acid-glycollic acid copolymer.
The drug of the drug coating is rapamycin.
The specific implementation mode is as follows: the covering film is a high-performance covering film material compounded by modified chitosan, particularly carboxymethyl chitosan and low molecular weight polylactic acid-glycollic acid copolymer, wherein the carboxymethyl chitosan is taken as a main component, the ratio reaches 60% -70%, the high substitution degree is more than 80%, the water solubility and the adhesiveness of the material are ensured, the covering film can be tightly attached to the inner wall of a blood vessel at 37 ℃, meanwhile, the covering film can be rapidly degraded into non-toxic and good-biocompatibility glucosamine, the support is provided for early repair, the low molecular weight PLGA has a molecular weight of 3-5kDa, the lactic acid/glycollic acid ratio of 50:50 is taken as an auxiliary component, the ratio is 30% -40%, the mechanical strength and the flexibility of the covering film are enhanced, the covering film is prevented from being broken or deformed in the balloon expanding process, and the covering film is completely degraded within 1 month by regulating the degradation rate, the degradation products of lactic acid and glycolic acid are nontoxic and have definite metabolic paths, the thickness of the covering film is controlled between 10-20 mu m, good adherence performance is ensured, blood flow dynamics is not disturbed, the drug coating is rapamycin coating, the rapamycin coating provides short-term drug release by directly spraying on the surface of the film at the drug concentration of 1-2 mu g/mm2, 70% -80% of the drug can be rapidly released within 1 week, the rest of the drug is completely released within 2 weeks, vascular smooth muscle cell proliferation is effectively inhibited, the restenosis problem in the stent during the degradation of the covering film can be ensured, and complex slow release technology is not needed, because the covering film has water solubility, the covering film contacts with blood and gradually dissolves to enable the outer surface of the covering film to have viscosity, after the air bag 5 is unfolded, the covering film is adhered to the opening of the vessel inner wall aneurysm in the vessel, and when the air bag 5 is contracted, the contact surface of the air bag 5 and the covering film is dry, the covering film does not follow the contraction of the air bag 5 but moves along with the contraction of the air bag 5, and the covering film is separated from the air bag 5.
Embodiment two:
The embodiment provides a technical scheme based on the first embodiment, the application method of the degradable medicine coating film covered balloon catheter is suitable for the degradable medicine coating film covered balloon catheter, and the application method of the degradable medicine coating film covered balloon catheter is used for using the degradable medicine coating film covered balloon catheter and comprises the following steps:
S1, preparing a Y-shaped connecting valve 1, a guide catheter 2, a guide wire 4 and a double-cavity balloon catheter 3, ensuring that the parts of the Y-shaped connecting valve 1, the guide catheter 2, the guide wire 4, the balloon 5 coated with a drug covering film 6 on the double-cavity balloon catheter 3 and the like are intact, and ensuring that all the connecting parts are firm and reliable;
S2, sterilizing the Y-shaped connecting valve 1, the guide catheter 2, the guide wire 4 and the double-cavity balloon catheter 3, ensuring sterile operation, and checking whether a drug coating on the drug covering film 6 is uniform and complete;
S3, carrying out anesthesia treatment on the patient, and allowing the patient to take a proper body position for guiding the insertion and operation of the catheter 2;
inserting a guide wire 4 into a guide wire cavity of the double-cavity balloon catheter 3 through the Y-shaped connecting valve 1 until the guide wire 4 extends to the outer side of the double-cavity balloon catheter 3 and reaches a target position;
Under the guidance of the guide wire 4, the double-cavity balloon catheter 3 is inserted into the body along the guide catheter 2 until reaching the preset treatment position;
S4, injecting a proper amount of liquid into the balloon 5 through the expansion cavity of the double-cavity balloon catheter 3, so that the balloon assembly is expanded and clings to the vessel wall or the treatment area, pre-expanding is carried out on the vascular lesion position, meanwhile, the medicine covering film 6 coated on the outer side of the balloon 5 is adhered to the inner wall of the vessel, and the medicine of the medicine covering film 6 is released and acts on the treatment position;
S5, extracting the liquid in the balloon assembly through the expansion cavity of the double-cavity balloon catheter 3, retracting the balloon assembly and restoring the balloon assembly, adhering and staying the medicine covering film 6 on the inner wall of the blood vessel to ensure that the medicine is fully released and acts, and withdrawing the guide wire 4, the double-cavity balloon catheter 3 and the guide catheter 2 from the patient.
While certain exemplary embodiments of the present invention have been described above by way of illustration only, it will be apparent to those of ordinary skill in the art that modifications may be made to the described embodiments in various different ways without departing from the spirit and scope of the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive of the scope of the invention, which is defined by the appended claims.