CN115999024A - Drug release control device - Google Patents
Drug release control device Download PDFInfo
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- CN115999024A CN115999024A CN202310294657.2A CN202310294657A CN115999024A CN 115999024 A CN115999024 A CN 115999024A CN 202310294657 A CN202310294657 A CN 202310294657A CN 115999024 A CN115999024 A CN 115999024A
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- release control
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract
The invention relates to the technical field of medical instruments and discloses a drug release control device, which comprises a balloon catheter, wherein an inflatable isolation layer is wrapped outside a balloon of the balloon catheter, a plurality of openings are formed in the surface of the isolation layer, the initial size of each opening is smaller than the size of drug particles of a drug coating, the balloon drives the external isolation layer to expand in an inflated state, and the expanded size of each opening allows the drug particles to enter a target position through the openings; the balloon catheter is internally provided with a drug release control element. The device can control the accurate release of the medicine, improve the utilization rate of the medicine and reduce the waste; avoiding thrombus caused by large-particle medicines or carriers easily entering blood vessels; the balloon is prevented from losing a large amount of medicines in the conveying process, and the utilization rate of the medicines is low; can perform targeted therapy and prevent drugs from performing non-targeted blood vessels; the isolating layer absorbs excessive energy to avoid vascular damage.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to a drug release control device.
Background
Balloon dilation is an important technical means in the field of interventional operations, and has been studied and widely applied to the treatment of coronary heart disease, cerebral vessels, arteriosclerosis of lower limbs and other diseases. The balloon, an important component of balloon dilation catheters and stent delivery systems, is given more functional requirements in the face of more complex, difficult lesions.
Along with the progress of science and technology, interventional therapy technology of coronary arteries and peripheral blood vessels is rapidly developed. Patients benefit tremendously from initial percutaneous balloon dilation catheterization, to the placement of bare metal stents and drug eluting stents. However, new problems are also created. Although drug eluting stents significantly reduce the incidence of restenosis within the stent, it is still not completely avoided and once drug eluting stent restenosis occurs, treatment is more difficult. In addition, delayed vascular endothelial healing, poor adhesion of late stent, thrombosis in stent, new atherosclerosis, etc. caused by drug eluting stent become new problems affecting clinical prognosis. The new technology, namely the drug balloon dilation catheter, which is developed in recent years, realizes the effects of treating serious lesions, improving blood supply and vascular functions of peripheral blood vessels of coronary arteries, and avoiding a series of problems caused by stent implantation without leaving permanent implants in the blood vessels, and also provides possibility for receiving and retreating the lesion blood vessels.
At present, companies such as Belgo medical treatment, medun force, maidelid, belgo medical treatment, beijing first Ruida, liaoning boundary medical treatment and the like develop drug coating balloons successively, the surface structure of the existing balloon enables the transfer rate of the surface drug of the balloon to be lower, the loss of the drug in the balloon conveying and expanding process is more than 80%, the drug quantity penetrating into blood vessels directly influences the treatment effect, the smaller the drug quantity contained in the drug coating influences the product effectiveness, meanwhile, if the quantity of the dropped particles is large, the dropped particles easily cause complications such as occlusion, embolism and the like of a cavity or a tube body with a smaller far end, and amputation can be caused by serious patients. The main influencing factors of the influence of blood vessels and blood flow on the drug balloon include: the erosion of the coating of the drug balloon by the blood flow, the friction of the drug balloon in the blood vessel, several factors correspond to the primary property of the balloon being the firmness of the coating. Meanwhile, when the medicine balloon catheter is withdrawn from the body, the residual medicine is still on the balloon, and the medicine actually released to the human body is less than 10%.
The prior art has the advantages that the drug balloon catheter, the drug balloon catheter system and the control method thereof provided by the publication No. CN 113117220A are improved, but the particle size of the fallen substances cannot be controlled, the impact wave energy is small, the drug coating is not fallen or falls off in a large block form, and the large particles are easy to cause thrombus; the energy is large, the medicine coating is smashed and falls off, thrombus cannot be caused, but the blood vessel is easily damaged due to the too high energy.
Disclosure of Invention
In order to solve the problems, the invention provides the following technical scheme:
the balloon catheter comprises a balloon catheter, wherein an inflatable isolation layer is wrapped outside the balloon of the balloon catheter, a drug coating is arranged on the outer surface of the balloon, and the drug coating is positioned between the balloon and the isolation layer;
the surface of the isolating layer is provided with a plurality of openings, the initial size of each opening is smaller than the size of the drug particles of the drug coating, the balloon drives the external isolating layer to expand in an expanded state, and the expanded size of each opening allows the drug particles to pass through the openings and enter the target position;
a drug release control element is arranged in the balloon and is used for promoting the release of the drug;
the isolation layer is used for buffering the energy of the drug release control element and reducing vascular injury in the drug release process;
the drug release control element is connected with an external drug release control mechanism;
in the initial state, the saccule is in a folding state, the isolating layer is sleeved outside the saccule, and two ends of the isolating layer are respectively connected with two ends of the saccule.
As a further description of the above technical solution, the expanded size is not larger than the size of the drug particles, and the expanded size is larger than the size of the small particles into which the drug particles are dispersed.
As further description of the technical scheme, the isolation layer is made of elastic damping materials, and the expansion rate of the isolation layer is 100% -1000%.
As a further description of the above technical solution, the material of the isolation layer is selected from silica gel, TPU, TPE, PVC or latex.
As a further description of the above technical solution, the drug coating is an active drug, and the drug coating is adhered to the surface of the balloon by an excipient.
As a further description of the above technical solution, the balloon surface is formed with a plurality of pit structures for adhering the drug particles.
As a further description of the above technical solution, the drug coating layer is formed by coating crystalline drug particles on the surface of the balloon.
As a further description of the above technical solution, the drug particles on the surface of the drug coating layer are wrapped in hydrogel microspheres and coated on the surface of the balloon by an excipient.
As a further description of the above technical solution, the drug particles of the drug coated surface are coated with the outer surface of the balloon by means of a bio-adhesive hydrogel sheet.
As a further description of the above technical solution, the drug release control element is a shock wave generator or a light beam emitter, and the corresponding drug release control mechanism is a high-voltage generator or a control light source.
Advantageous effects
Compared with the prior art, the invention provides a drug release control device, which has the following beneficial effects:
1. according to the invention, the drug coating is arranged on the surface of the balloon, the isolation layer is wrapped outside the drug coating, micropores and/or micro-seams are formed on the surface of the isolation layer, and the isolation layer can isolate the blood vessel from the drug coating when the balloon is conveyed in the blood vessel.
2. According to the invention, the drug layer on the surface of the saccule is released by the shock wave emitter to act, the drug carrying layer can be dispersed into fine particles, when the size of the drug carrying particles is smaller than that of the holes or slits, the drug carrying particles can enter the inner wall of a blood vessel to act through the holes or slits, at the moment, the drug carrying layer can act as a sieve to prevent large particles from entering the blood vessel to cause complications such as thrombus, at the moment, the dispersion efficiency of the drug can be controlled by controlling the input energy of equipment, the release efficiency of the drug can be controlled, meanwhile, the penetrability of the drug entering the inner wall of the blood vessel can be improved by the energy and the release frequency of the shock wave, the absorption of the blood vessel can be promoted, and the release of the drug to non-target lesions can be avoided by independently controlling the shock wave emitter of the control equipment according to the lesion conditions;
3. when the energy input of the control equipment is controlled according to pathological conditions, the isolation layer has the functions of absorbing part of energy and protecting blood vessels in order to prevent the pulse energy released by the shock wave transmitting element from damaging the blood vessels.
Drawings
FIG. 1 is a schematic view of a first embodiment of the present invention;
FIG. 2 is a schematic view of the balloon according to the first embodiment of the present invention after inflation;
FIG. 3 is a cross-sectional view of the balloon of the present invention mated with a drug coating and barrier layer prior to inflation of the balloon;
FIG. 4 is a cross-sectional view of the balloon of the present invention mated with a drug coating and barrier layer after inflation of the balloon;
FIG. 5 is a schematic view of micropores formed in the surface of the isolation layer according to the present invention;
FIG. 6 is a schematic view of micro-cracks formed in the surface of the isolation layer of the present invention;
FIG. 7 is a schematic illustration of the drug particles of the present invention adhering to the surface of a balloon;
FIG. 8 is another schematic illustration of the drug particles of the present invention adhered to the surface of a balloon;
FIG. 9 is another schematic illustration of the drug particles of the present invention adhered to the surface of a balloon;
FIG. 10 is a schematic diagram of a second embodiment of the present invention;
fig. 11 is a schematic structural diagram of the balloon according to the second embodiment of the present invention after inflation.
In the figure: 1. a balloon catheter; 101. an outer tube; 102. an inner tube; 2. a balloon; 3. an isolation layer; 31. micropores; 32. micro-joint; 4. a drug coating; 401. an excipient; 402. drug particles; 403. gel microspheres; 404. a gel sheet; 7. a drug release control element; 8. a wire rod; 9. a drug slow release control mechanism; 10. a developing ring; 11. and a connecting seat.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Referring to fig. 1-9, an embodiment of the present invention is provided: a drug release control device comprises a balloon catheter 1, wherein an inflatable isolation layer 3 is wrapped outside a balloon 2 of the balloon catheter 1, two ends of the isolation layer 3 are fixed at two ends of the balloon 2 and used for absorbing energy of multiple aftershock waves, the connection mode of the isolation layer 3 and the balloon 2 can be one of gluing, thermal welding or laser welding, the balloon 2 can be selected according to actual conditions, in an unexpanded state, the number of folded wings is different according to the diameter of the balloon 2. The balloon catheter 1 comprises an inner tube 102 and an outer tube 101, wherein developing rings 10 are fixed at two ends of the inner tube 102 inside the balloon 2, the positions of the balloon 2 can be identified in an auxiliary mode through the developing rings 10, a drug coating 4 is arranged on the outer surface of the balloon 2, and the drug coating 4 is positioned between the balloon 2 and the isolation layer 3;
referring to fig. 5 to 6, a plurality of openings are formed on the surface of the isolation layer 3, the openings can be micropores 31 and/or micro-slits 32, wherein the micropores 31 can be round holes, elliptical holes or square holes, etc., the micro-slits 32 can be transversely or longitudinally formed, the initial size of the micropores 31 and/or micro-slits 32 is smaller than the size of the drug particles 402 of the drug coating 4, the balloon 2 drives the external isolation layer 3 to expand in a liquid-filled expansion state, the size of the micropores 31 and/or micro-slits 32 is larger than the size of the drug particles 402 or smaller than the size of the drug particles 402, only the size of the micropores 31 and/or micro-slits 32 is required to be ensured to be larger than the size of the dispersed drug particles 402, the drug particles 402 penetrate through the micropores 31 and/micro-slits 32 to enter the target position, the isolation layer 3 can be made of elastic damping materials such as silica gel, TPU, TPE, PVC or latex, etc., so that when the balloon 2 expands through the liquid or gas entering through the gaps, the external isolation layer 3 can expand together, and after the isolation layer 3 expands, the size of the micropores 31 and/or micro-slits 32 is larger than the size of the drug particles 4, thereby realizing the effect of releasing drug particles from the drug particles and the drug particles 4 through the size control of the drug particles and the original size expansion of the drug particles 4; meanwhile, when the balloon 2 is conveyed in a blood vessel, blood and the drug coating 4 can be isolated through the isolating layer 3, so that the loss of the drug in the conveying process is avoided; under the action of the shock wave, the separation layer 3 can absorb part of energy emitted by the drug release control element 7 while accelerating the fragmentation of the drug, releasing the drug to the lesion and penetrating the lesion, so as to prevent the pulse energy released by the shock wave transmitting god element from damaging the blood vessel and protect the blood vessel.
In order to keep the balloon 2 small in passing outside diameter, the drug balloon 2 is folded and then the isolation layer 3 is installed as shown in fig. 3 during the product processing. As shown in fig. 8, the drug particles 402 on the drug coating 4 can be active drugs, and firmly adhere to the surface of the balloon 2 under the action of strong excipient, and the size of the drug particles 402 is controlled to be larger than the size of the holes and/or slits on the isolation layer 3 before expansion and smaller than the size of the holes and/or slits after expansion and expansion of the isolation layer 3, and due to the existence of the isolation layer 3, the drug loss of the device in the conveying process can be reduced, when the device is placed in a lesion position, the drug falls off from the surface of the balloon 2 under the action of vibration waves after the balloon 2 is expanded and enters the lesion, and the transmission of the drug and the absorption of the drug by the lesion blood vessel can be accelerated under the action of the vibration waves; or the active medicine is made into crystal particles which are directly coated on the outer surface of the saccule 2, as shown in figure 9, the size of the medicine particles 402 is larger than the size of the separation layer 3 before expansion, after the saccule 2 is expanded, the pore diameter on the separation layer 3 is enlarged, and the medicine with proper size can be directly released to the lesion blood vessel. Under the action of the vibration wave, on one hand, the absorption of the medicine released to the lesion can be promoted, on the other hand, the large-particle medicine can be crushed so as to enter the lesion vessel and be absorbed by tissues, and meanwhile, as the medicine is crushed, the size of the medicine is reduced, the balloon does not need to be expanded to an excessive size so that micropores 31 and/or micro-slits 32 on the surface can pass through the large-size particles, the trafficability of the balloon in the narrow vessel can be improved, and the damage to the narrow vessel is reduced. Or the active medicine and the medicine carrier form a crystal mixture to be coated on the surface of the saccule 2; or the medicine is wrapped in hydrogel microspheres 403 and coated on the surface of the balloon 2 under the action of an excipient 401 as shown in fig. 7; or the surface of the saccule 2 or the medicine is modified respectively to form hydrogen bonds, so that the medicine is firmly adhered to the surface of the saccule 2, the medicine coating 4 can be firmly fixed on the surface of the saccule 2 in the mode, the medicine is not easy to release, and the aim of slow release can be achieved under the action of vibration waves. In order to allow a uniform diffusion distribution of the drug while avoiding dissolution and washout of the drug by the blood during delivery, excipient 401 is preferably a triglyceride, triacetate, caprate or caprylic acid triglyceride having hydrophobicity and biocompatibility, and more preferably a triglyceride, so that the entire drug coating 4 of balloon 2 is rendered hydrophobic. The drug is preferably a macrolide immunosuppressant, a macrolide antibiotic, rapamycin, a structural derivative and functional analogue of rapamycin, everolimus, a structural derivative and functional analogue of everolimus, paclitaxel, a taxane, a temsirolimus compound, zolsirolimus, everolimus, sirolimus, myolimus, deforolimus, tacrolimus or a structure of temsirolimus or a temsirolimus compound. The microsphere is hydrogel, is a three-dimensional network structure formed by polyvinyl alcohol, polylactic acid and the like, and can effectively wrap active drugs. In order to increase the firmness of the drug and the surface of the balloon 2, the surface of the balloon 2 may be in a pit structure.
To illustrate that the balloon 2 has a smaller passing outer diameter, the present invention directly sleeves the isolation layer 3 outside the balloon 2 in the folded state, and under the same specification (i.e. the thickness of the isolation layer 3 and the thickness of the balloon 2 are the same as those of the outer balloon and the inner balloon in the prior art, the isolation layer 3 corresponds to the outer balloon, and the balloon 2 corresponds to the inner balloon), the cross-sectional dimension of the balloon in the initial state in the present invention is smaller than that of the balloon in the initial state in the prior art, and the specific principle is that: the thickness of the inner and outer balloons is necessarily larger than the folded size of the single inner balloon, the unfolded isolation layer 3 is sleeved on the outer surface of the single folded balloon 2, and the thickness of the isolation layer 3 in the unfolded state is necessarily smaller than that of the folded outer balloon in the prior art, so that the cross-sectional size of the balloon 2 in the initial state is smaller than that of the balloon in the initial state in the prior art, the balloon in the initial state has better vascular passing performance than that of the balloon in the prior art, the application range of the balloon in the application can be wider and more comprehensive, and if the balloon in the application range of the application is required to enter the narrower vascular, the thickness of the inner and outer balloons can be changed only to reduce the cross-sectional size of the balloon in the prior art, so that the cross-sectional size of the balloon in the initial state can be correspondingly reduced, but the thickness of the inner and outer balloons can be changed, and the inflation performance of the balloon can be influenced for subsequent use.
Referring to fig. 10-11, the drug release control element 7 is fixed on the inner tube 102 inside the balloon 2, and the drug release control element 7 is electrically connected with the external drug release control mechanism 9 through the wire 8, in this embodiment, the drug release control element 7 is a shock wave emitting element, and the wire 8 is a wire with an insulating sheath, the drug release control mechanism is a high voltage generator, the specific shock wave emitting element is composed of an electrode pair and a non-conductive gap, the shock wave emitting element can be composed of one or more groups of electrodes, after assembly connection, the shock wave emitting element only leaves a channel discharging in the radial direction, and is connected to the drug release control device (high voltage generator) through the wire, two electrodes of each group of electrodes of the shock wave emitting element can be communicated in the radial direction through conductive solutions such as normal saline and/or contrast agents, the shock wave emitting element can be controlled by the drug release control device (high voltage generator), after the balloon 2 is expanded by using the solution such as normal saline and/or contrast agents, and each group of electrodes of the shock wave emitting element can perform pulse release on the surface of the conductive medium section in the radial direction through the channel in the radial direction. The shock wave catheter is connected to a drug slow-release control device (high-voltage generator) through an extension line or a control handle, and the release of the pulse can be controlled through a button or a foot switch on the control handle.
In other embodiments, the drug release control element 7 may be a light beam emitter, the wire 8 is an optical fiber, and the corresponding drug release control mechanism 9 is a control light source, where the drug release control element is one end of an optical fiber bundle, and the other end extends from the connection seat 11 and may be connected to the control light source. Near infrared light is transmitted into the balloon 2 by an optical fiber, the outer surface of the balloon 2 is provided with a drug layer, the drug layer is composed of microspheres with photo-thermal response materials and an excipient 401 which encapsulate active drugs, as shown in fig. 7, the photo-thermal response materials have near infrared response, can convert light into heat, and promote melting of gel microspheres 403, thereby promoting release of the drugs. Alternatively, as shown in fig. 8, the active agent is coated on the balloon 2 through a bio-adhesive hydrogel sheet 404, the bio-adhesive gel sheet 404 can be controlled by near infrared, and the active agent is released to the lesion site after detachment.
Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made therein without departing from the principles and spirit of the invention, the scope of which is defined in the appended claims and their equivalents.
Claims (10)
1. A drug release control device comprising a balloon catheter, characterized in that: an inflatable isolation layer is wrapped outside the balloon of the balloon catheter, a drug coating is arranged on the outer surface of the balloon, and the drug coating is positioned between the balloon and the isolation layer;
the surface of the isolating layer is provided with a plurality of openings, the initial size of each opening is smaller than the size of the drug particles of the drug coating, the balloon drives the external isolating layer to expand in an expanded state, and the expanded size of each opening allows the drug particles to pass through the openings and enter the target position;
a drug release control element is arranged in the balloon and is used for promoting the release of the drug;
the isolation layer is used for buffering the energy of the drug release control element and reducing vascular injury in the drug release process;
the drug release control element is connected with an external drug release control mechanism;
in the initial state, the saccule is in a folding state, the isolating layer is sleeved outside the saccule, and two ends of the isolating layer are respectively connected with two ends of the saccule.
2. The drug release control device according to claim 1, wherein: the expanded size is not greater than the size of the drug particles, and the expanded size is greater than the size of the small particles into which the drug particles are dispersed.
3. The drug release control device according to claim 1, wherein: the isolation layer is made of elastic damping materials, and the expansion rate of the isolation layer is 100% -1000%.
4. A drug release control device as in claim 3, wherein: the material of the isolation layer is selected from silica gel, TPU, TPE, PVC or latex.
5. The drug release control device according to claim 1, wherein: the drug coating is an active drug and is adhered to the surface of the balloon by an excipient.
6. The drug release control device according to claim 1, wherein: the surface of the balloon is formed with a plurality of pit structures for adhering drug particles.
7. The drug release control device according to claim 1, wherein: the drug coating is formed by coating crystalline drug particles on the surface of the balloon.
8. The drug release control device according to claim 1, wherein: the drug particles on the surface of the drug coating are wrapped in hydrogel microspheres and are coated on the surface of the balloon through an excipient.
9. The drug release control device according to claim 1, wherein: the drug particles on the surface of the drug coating are coated with the outer surface of the balloon by a bio-adhesive hydrogel sheet.
10. The drug release control device according to claim 1, wherein: the medicine release control element is a shock wave generator or a light beam emitter, and the corresponding medicine release control mechanism is a high-voltage generator or a control light source.
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CN202310294657.2A CN115999024A (en) | 2023-03-24 | 2023-03-24 | Drug release control device |
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CN202310294657.2A CN115999024A (en) | 2023-03-24 | 2023-03-24 | Drug release control device |
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CN113440215A (en) * | 2021-07-23 | 2021-09-28 | 上海佳沐垚医疗科技有限公司 | Shock wave generating device and conduit system |
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