Microneedle ultrasonic self-perfusion medicine balloon

Abstract

The invention relates to a microneedle ultrasonic self-perfusion medicine balloon which comprises a medicine combination balloon body, the medicine combination balloon body comprises a medicine feeding balloon body and an expansion balloon body which are arranged in a split mode, the medicine feeding balloon body is arranged on the outer side of the expansion balloon body, and a gap between the expansion balloon body and the medicine feeding balloon body forms a medicine feeding cavity of the medicine combination balloon body; the dilation balloon is provided with a microneedle, a balloon body of the drug delivery balloon comprises a microporous permeable membrane, the microporous permeable membrane is provided with a water-soluble microneedle hole membrane, and the position of the microneedle is opposite to the position of the water-soluble microneedle hole membrane in the radial direction of the drug combination balloon. According to the microneedle ultrasonic self-perfusion drug balloon, different structures of the balloon can be in contact with a vascular lesion site for drug administration, so that the drug is fully and completely released without loss, the acting time of the drug balloon is prolonged, the drug administration condition of the drug balloon can be improved to the greatest extent, and the drug administration absorptivity is improved.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a microneedle ultrasonic self-infusion drug balloon. Background Art

[0002] Drug-eluting balloons are commonly used to treat cardiovascular diseases. They can inhibit the proliferation of dilated vascular smooth muscle cells and prevent restenosis after vascular dilation. Drug-eluting balloons have significant therapeutic effects in interventional treatment. The drug coating is applied to the surface of the balloon, and the balloon is delivered to the lesion site through a catheter. The balloon expands in the blood vessel. The balloon expansion time is short. It is necessary to ensure that the drug coating is transferred to the blood vessel wall during the balloon inflation period and that the drug can be effectively released to improve the absorption of water-insoluble therapeutic agents; at the same time, the integrity of the drug coating must be ensured during the delivery of the drug balloon.

[0003] Traditional drug balloons lose too much drug during the delivery process and cannot be accurately released at the lesion site. Some drug particles also fall off, causing distal embolism.

[0004] Traditional drug balloons spray drugs on the outer surface of the balloon. The drug content is fixed, the expansion time does not exceed 60s, and the drug content released at the lesion site is low, and the absorption rate is low.

[0005] If the drug-eluting balloon is inflated for too long, the blood vessels will be completely blocked when the balloon is in a compressed state, causing discomfort such as chest tightness in the patient.

[0006] The traditional drug balloon delivery method acts directly on the inner wall of the blood vessel, and the lesion site is passively absorbed with a low absorption rate. Summary of the invention

[0007] The purpose of the present application is to provide a microneedle ultrasonic self-perfusion drug balloon, which can improve the drug administration condition of the drug balloon and increase the absorption rate of the drug in the lesion site.

[0008] In order to achieve the above-mentioned object, the present invention provides a microneedle ultrasonic self-perfusion drug balloon, comprising: a drug-combined balloon, the drug-combined balloon comprising a separately arranged drug-delivery balloon and an expansion balloon, the drug-delivery balloon being arranged outside the expansion balloon, and the gap between the expansion balloon and the drug-delivery balloon constituting a drug-delivery cavity of the drug-combined balloon;

[0009] The expansion balloon is provided with a microneedle, the capsule body of the drug administration balloon includes a microporous permeable membrane, a water-soluble microneedle pore membrane is provided on the microporous permeable membrane, and the microneedle and the water-soluble microneedle pore membrane are opposite to each other in the radial direction of the drug binding balloon;

[0010] After the expansion balloon is pressurized and expanded, the microneedles can pierce the water-soluble microneedle pore membrane and protrude and expose on the outer surface of the drug delivery balloon;

[0011] The microneedle comprises a drug storage bag and a microneedle head with a hollow structure, the drug storage bag is filled with drugs, the microneedle head is connected to the space of the drug storage bag and a microneedle hole is arranged on the microneedle head;

[0012] The expansion balloon comprises a sound-conducting liquid cavity, the sound-conducting liquid cavity is penetrated by an inner tube, an electrode ring is arranged on the inner tube, the electrode ring is connected to an electrode plug through a wire, and the electrode plug is externally connected to an ultrasonic generator;

[0013] The distal tube opening of the inner tube is arranged at the balloon tip of the drug-integrated balloon and communicates with the outside world, and the proximal tube opening is arranged on the outer tube of the drug-integrated balloon and connected to the outer tube at the guide wire opening of the balloon catheter. The outer tube is provided with a self-infusion hole, and the self-infusion hole is arranged at the distal end of the guide wire opening and communicates with the lumen of the inner tube.

[0014] In an optional embodiment, the microneedles are disposed on the outer surface of the expansion balloon and arranged in a linear array, including multiple rows disposed in the circumferential direction of the expansion balloon, and the microporous permeable membrane includes multiple channels disposed on the drug delivery balloon, and each channel of the microporous permeable membrane is opposite to the position of each column of the microneedles.

[0015] In an optional embodiment, the expansion balloon comprises a compliant balloon, the drug administration balloon comprises a non-compliant balloon, and the diameter of the drug administration balloon is greater than the diameter of the expansion balloon;

[0016] The microneedle head comprises a pointed cone-shaped structure. After the expansion balloon is pressurized and expanded, the microneedle head with the pointed cone-shaped structure pierces through the water-soluble microneedle pore membrane and is tightly embedded in the microporous permeable membrane of the drug delivery balloon.

[0017] In an optional embodiment, the drug storage bag includes an elastic bag body, the elastic bag body is bonded to the outer surface of the expansion balloon, and the microneedle hole is arranged on the annular side wall of the microneedle head;

[0018] The expansion balloon and the medication balloon are overlapped inside and outside, and the expansion balloon and the medication balloon are respectively arranged in petals. In the conveying state, the medication balloon and the expansion balloon are curled and wrapped.

[0019] In an optional embodiment, the outer tube is arranged at the proximal end of the drug binding balloon, and a drug storage control ring is connected between the drug binding balloon and the outer tube, the drug storage control ring includes an internal drug storage ring cavity, the drug storage ring cavity is communicated with the drug delivery cavity, and the outer tube includes a drug delivery lumen for supplying drugs to the drug delivery cavity, and the drug delivery lumen is communicated with the drug storage ring cavity.

[0020] In an optional embodiment, the drug storage control ring includes at least one axial length, and two diaphragm valve plates are disposed opposite to each other at the proximal end of the drug storage ring cavity, each diaphragm valve plate includes a semicircular ring structure, and the two diaphragm valve plates can be staggered and overlapped to seal and isolate the drug storage ring cavity from the drug delivery lumen;

[0021] The diaphragm valve plate is connected to the inner side wall of the outer tube, and a return spring is arranged between the connection roots of the outer tube and the diaphragm valve plate. The return spring has an elastic tendency to force the diaphragm valve plate to overlap in a staggered manner.

[0022] In an optional embodiment, the sound-conducting liquid cavity is sealed and isolated from the drug delivery cavity, the inner tube runs through the entire axial direction of the sound-conducting liquid cavity, and the electrode rings include a plurality of electrode rings, which are respectively sleeved on the outer side wall of the inner tube and are evenly spaced in the length direction of the inner tube.

[0023] In an optional embodiment, the outer tube includes a pressurized tube cavity for filling the sound-conducting liquid cavity with sound-conducting liquid, the pressurized tube cavity is connected to the sound-conducting liquid cavity, each of the electrode rings is electrically connected to the electrode plug via an electrode wire, a temperature sensor is provided in the sound-conducting liquid cavity, the temperature sensor is electrically connected to the electrode plug via a sensing wire, the electrode wire and the sensing wire extend outward through the pressurized tube cavity, and the electrode plug is pluggably installed on the ultrasonic generator.

[0024] In an optional embodiment, the proximal end of the outer tube is connected to a Y-shaped catheter seat, and the Y-shaped catheter seat is provided with a drug delivery port and a charging port, the drug delivery port is communicated with the drug delivery lumen, and the charging port is communicated with the charging lumen.

[0025] In an optional embodiment, a timer is provided on the ultrasonic generator, and the frequency of the ultrasonic generator is 20kHz-3MHz, and the intensity is 0.5-2W / cm 2 , output pulse ultrasonic wave;

[0026] The height of the microneedle is 800 μm to 1200 μm, and the diameter of the bottom of the drug storage capsule is 200 μm to 400 μm;

[0027] The material of the water-soluble micro-pinhole membrane is any one of polytetrafluoroethylene, polymethyl methacrylate and glass fiber paper;

[0028] The outer surface of the inner tube is sleeved with a developing marking ring.

[0029] The separately arranged drug delivery balloon and expansion balloon can make the expansion balloon expand the drug delivery balloon, drive the overall expansion of the drug-combined balloon, and make the drug delivery balloon fit the diseased part of the blood vessel.

[0030] The squeezing force exerted by the expansion balloon on the drug delivery balloon causes the drug delivery cavity formed by the gap between the two to be subjected to bidirectional compression from the inside to the outside, thereby releasing the drug in the drug delivery cavity outward through the microporous permeable membrane and directly acting on the outside of the lesion site, greatly reducing the scouring loss of the drug balloon during the delivery process and achieving precise drug release.

[0031] The microneedle can pierce the drug-delivery balloon after the expansion balloon is pressurized and expanded, protruding from the outer surface of the drug-delivery balloon and piercing into the interior of the lesion. Combined with the drug storage capsule and the microneedle head with a hollow structure, the drug storage capsule can be squeezed under the action of double-layer compression. During the squeezing process, the liquid drug in the drug storage capsule can be released through the microneedle holes on the microneedle head, so that the released drug can directly act on the interior of the lesion, thereby realizing the precise release of the drug on the other hand.

[0032] By setting the microporous permeable membrane as a part of the capsule structure of the drug delivery balloon itself, it is possible to construct a microporous structure on the drug delivery balloon, so that the released drug in the drug delivery cavity can act on the vascular lesion site to which the drug delivery balloon is attached.

[0033] The water-soluble microneedle pore membrane is arranged on the microporous permeable membrane. The microneedle and the water-soluble microneedle pore membrane are opposite in radial direction of the drug-binding balloon, which can accurately perform puncture operation and facilitate the combination of the expansion balloon and the drug-delivery balloon through embedding.

[0034] The expansion balloon is expanded by pressurizing the sound-conducting liquid cavity and filling it with sound-conducting liquid. The electrode ring on the inner tube in the sound-conducting liquid cavity generates ultrasonic waves through the cooperation of an ultrasonic generator, an electrode plug and a wire, thereby performing ultrasonic operations.

[0035] The microbubbles in the sound-conducting liquid will vibrate and burst under the action of ultrasound. The shock waves and microjets generated during the vibration and burst can increase the permeability of diseased tissues and cells and promote the entry of drugs into cells.

[0036] Ultrasound can form temporary micropores on the cell membrane, making it easier for drugs to enter the cells, increasing the concentration of drugs in target cells and tissue cells in the lesion area, and enhancing the therapeutic effect.

[0037] A self-perfusion hole is arranged on the outer tube, and the self-perfusion hole is arranged at the distal end of the guide wire port and communicated with the lumen of the inner tube, so that a self-perfusion channel for blood can be formed between the proximal and distal ends of the drug-combined balloon, thereby achieving uninterrupted blood supply, prolonging the fitting time between the drug balloon and the outside of the lesion site of the blood vessel wall, and the penetration time of the microneedle head inside the lesion site, and combined with the simultaneous execution of ultrasonic operation, the absorption rate of microneedle drug administration and release drug administration is improved to the greatest extent.

[0038] Through the microneedle ultrasonic self-perfusion drug balloon in the present invention, the different structures of the balloon can contact the vascular lesion site and deliver the drug, so that the drug can be fully and completely released without loss, extending the action time of the drug balloon, and at the same time being able to improve the drug delivery conditions of the drug balloon to the greatest extent and increase the absorption rate of the drug delivery.

[0039] Other features and advantages of the present application will be described in detail in the subsequent detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0041] Figure 1 This is a schematic diagram of the overall structure of the microneedle ultrasonic self-infusion drug balloon in this application;

[0042] Figure 2 Schematic diagram of the structure of the microneedle on the expansion balloon;

[0043] Figure 3 This is a schematic diagram of the structure of the microporous permeable membrane on the drug delivery balloon;

[0044] Figure 4 It is a structural schematic diagram of the diaphragm valve plate;

[0045] Figure 5 It is a schematic diagram of the structure of the diaphragm valve plate in the medicine storage ring cavity in the medicine injection state;

[0046] Figure 6 It is a schematic diagram of the structure of the expansion balloon and the drug delivery balloon after being pressurized and deployed.

[0047] icon:

[0048] 1- expansion balloon; 11- microneedle; 11a- microneedle head; 11b- drug storage capsule; 11c- microneedle hole;

[0049] 2-drug delivery balloon; 21-patch; 22-microporous permeable membrane; 23-water-soluble microneedle pore membrane;

[0050] 3-drug delivery cavity; 31-drug delivery lumen;

[0051] 4-sound-conducting liquid cavity; 41-pressurized tube cavity;

[0052] 5-wire guide port;

[0053] 6-drug storage control ring; 61-reset spring; 62-diaphragm valve plate; 63-drug storage ring cavity;

[0054] 7-inner tube; 71-development marking ring;

[0055] 8-catheter seat;

[0056] 9-ultrasonic generator; 91-electrode plug; 92-electrode ring; 93-electrode wire; 94-sensing wire; 95-timer; 96-temperature sensor;

[0057] 10-Self-priming holes. DETAILED DESCRIPTION

[0058] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application described and shown in the drawings here can be arranged and designed in various different configurations.

[0059] In the description of this application, it should be noted that the terms "inside", "outside", etc. indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the application is usually placed when in use, which is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application. In addition, the terms "first", "second", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0060] In the description of this application, it should also be noted that, unless otherwise clearly specified and limited, the terms "disposed" and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0061] The microneedle ultrasonic self-perfusion drug balloon in this application is mainly used to treat the lesion site in the vascular cavity. By setting a microneedle structure on the inner balloon and a microporous permeable membrane on the outer balloon, combined with the ultrasonic effect acting on the drug balloon as a whole, the drug administration conditions are improved and the absorption rate of the drug in the lesion site is increased. At the same time, combined with the self-perfusion hole set on the drug balloon catheter, an uninterrupted blood flow supply is formed, the expansion time of the drug balloon is prolonged, and the drug absorption is promoted.

[0062] See also Figure 1 , and combined with Figure 2-Figure 6The microneedle ultrasonic self-perfusion drug balloon of the present invention has a main structure including a drug-binding balloon, which includes a separately arranged drug-delivery balloon 2 and an expansion balloon 1. The drug-delivery balloon 2 is arranged on the outside of the expansion balloon 1, and the gap between the expansion balloon 1 and the drug-delivery balloon 2 constitutes a drug-delivery cavity 3 of the drug-delivery balloon.

[0063] By separately setting up the medication balloon 2 and the expansion balloon 1, and setting the medication balloon 2 on the outside of the expansion balloon 1, the expansion balloon 1 can expand the medication balloon 2 during the expansion process, and make the medication balloon 2 relatively squeezed inward, thereby driving the overall expansion of the drug-combined balloon and making the medication balloon 2 fit the diseased part of the blood vessel.

[0064] By the squeezing force generated by the expansion balloon 1 on the drug delivery balloon 2, the drug delivery cavity 3 formed by the gap between the two is subjected to relative internal and external bidirectional compression, that is, the expansion balloon 1 is expanded outwardly, and the drug delivery balloon 2 is squeezed inwardly, so that the drug in the drug delivery cavity 3 is released outwardly through the micropores on the drug delivery balloon 2, and then acts on the diseased part that fits the blood vessel wall, which can greatly reduce the scouring loss of the drug balloon during the transportation process, and can make the drug act directly on the outside of the diseased part, so as to achieve accurate release of the drug.

[0065] The expansion balloon 1 is provided with microneedles 11, and the capsule body of the drug administration balloon 2 includes a microporous permeable membrane 22, on which a water-soluble microneedle pore membrane 23 is provided. The microneedles 11 and the water-soluble microneedle pore membrane 23 are opposite in radial direction of the drug binding balloon.

[0066] After the expansion balloon 1 is pressurized and expanded, the microneedle 11 can pierce the water-soluble microneedle hole membrane 23 and protrude and expose on the outer surface of the drug delivery balloon 2. The microneedle 11 includes a drug storage capsule 11b and a hollow microneedle head 11a, the drug storage capsule 11b is filled with drugs, the microneedle head 11a is connected to the space of the drug storage capsule 11b, and a microneedle hole 11c is arranged on the microneedle head 11a.

[0067] The microneedles 11 arranged on the expansion balloon 1 can pierce the water-soluble microneedle pore membrane 23 of the drug administration balloon 2 after the expansion balloon 1 is pressurized and expanded, protrude from the outer surface of the drug administration balloon 2, and penetrate into the interior of the lesion under the outward expansion effect of the expansion balloon 1.

[0068] Combined with the drug storage capsule 11b and the hollow microneedle head 11a included in the microneedle 11, the drug storage capsule 11b with high elastic force can be bidirectionally squeezed under the double-layer compression action of the outward expansion of the expansion balloon 1 and the inward squeezing of the drug delivery balloon 2. The space of the microneedle head 11a and the drug storage capsule 11b is connected. During the squeezing process of the drug storage capsule 11b, the liquid drug in the drug storage capsule 11b can be released through the microneedle hole 11c on the microneedle head 11a that penetrates into the lesion site. At another angle, the released drug directly acts on the inside of the lesion site, thereby realizing further precise release of the drug.

[0069] By setting the microporous permeable membrane 22 as a part of the capsule structure of the drug delivery balloon 2, it is possible to construct a microporous structure on the drug delivery balloon 2, so that the released drug in the drug delivery cavity 3 can act on the vascular lesion site to which the drug delivery balloon 2 is attached.

[0070] The water-soluble microneedle pore membrane 23 is arranged on the microporous permeable membrane 22, which is conducive to the puncture operation of the microneedle 11. The microneedle 11 and the water-soluble microneedle pore membrane 23 are relative to each other in the radial direction of the drug-binding balloon, and the puncture operation can be performed accurately, and it is also conducive to the subsequent combination of the expansion balloon 1 and the drug-delivery balloon 2 through the microneedle 11.

[0071] The expansion balloon 1 includes a sound-conducting liquid cavity 4, and the expansion balloon 1 is expanded by pressurizing the sound-conducting liquid cavity 4 and filling it with sound-conducting liquid. The sound-conducting liquid cavity 4 is penetrated by an inner tube 7, and an electrode ring 92 is provided on the inner tube 7. The electrode ring 92 is connected to an electrode plug 91 through a wire, and the electrode plug 91 is externally connected to an ultrasonic generator 9. The ultrasonic generator 9 can be combined with the electrode plug 91 and the wire to make the electrode ring 92 on the inner tube 7 in the sound-conducting liquid cavity 4 generate ultrasonic waves, thereby performing ultrasonic operations.

[0072] The microbubbles in the sound-conducting liquid will vibrate and burst under the action of ultrasound. When the microneedle 11a penetrates into the lesion site, the shock waves and microjets generated during the vibration and burst can increase the permeability of the lesion tissue and cells and promote the entry of drugs into the cells.

[0073] Ultrasound can form temporary micropores on the cell membrane, making it easier for drugs to enter the cells. This operating mechanism increases the concentration of drugs in target cells and tissue cells at the site of disease, enhancing the therapeutic effect.

[0074] By setting the distal tube opening of the inner tube 7 at the balloon tip of the drug-binding balloon and communicating with the outside, and setting the proximal tube opening of the inner tube 7 on the outer tube of the drug-binding balloon and connecting the outer tube to the guidewire opening 5 of the balloon catheter, it is possible to facilitate the guiding and threading of the guidewire, and by setting a self-infusion hole 10 on the outer tube, combined with the self-infusion hole 10 being set at the distal end of the guidewire opening 5 and communicating with the lumen of the inner tube 7, a self-infusion channel for blood between the proximal and distal ends of the drug-binding balloon can be formed. When the drug-binding balloon is inflated and expanded, normal blood circulation between its proximal and distal ends is maintained, uninterrupted blood supply is achieved, the adhesion time between the drug balloon and the outside of the lesion site on the blood vessel wall, and the insertion time of the microneedle 11a inside the lesion site are prolonged, and combined with the simultaneous execution of ultrasonic operation, the absorption rate of drug administration and release of the microneedle 11 is improved to the greatest extent.

[0075] In one specific embodiment, the microneedles 11 are disposed on the outer surface of the expansion balloon 1 and arranged in a linear array. Furthermore, the microneedles 11 include multiple columns arranged circumferentially of the expansion balloon 1, and each column of microneedles 11 extends axially along the expansion balloon 1. Through this arrangement, the microneedles 11 in this embodiment include three columns evenly spaced circumferentially, and each column of microneedles 11 includes a plurality of equidistantly arranged microneedle structures, which can widen the coverage area of ​​the microneedles 11 on the expansion balloon 1, and further can stably puncture into the internal tissue of the lesion site.

[0076] The microporous permeable membrane 22 includes multiple layers arranged on the drug delivery balloon 2. Specifically, the microporous permeable membrane 22 is in the form of a patch 21 structure, which is a part of the structure of the drug delivery balloon 2 itself. Each microporous permeable membrane 22 is opposite to the position of each column of microneedles 11, so that each column of microneedles 11 can pierce the water-soluble microneedle hole membrane 23 on each microporous permeable membrane 22.

[0077] Preferably, the thickness of the water-soluble micro-needle hole membrane 23 is smaller than that of the microporous permeable membrane 22 , and the material of the water-soluble micro-needle hole membrane 23 is any one of polytetrafluoroethylene, polymethyl methacrylate and glass fiber paper, which can facilitate the microneedle 11a to puncture through the water-soluble micro-needle hole membrane 23 .

[0078] The expansion balloon 1 includes a compliant balloon. As the filling pressure increases, the diameter of the expansion balloon 1 increases, which enables the expansion balloon 1 to be pressurized and expanded, while expanding the drug-delivery balloon 2 outward, further driving the microneedle 11 to expand and move outward in the radial direction until it pierces the drug-delivery balloon 2 and penetrates the lesion.

[0079] The drug-delivery balloon 2 comprises a non-compliant balloon, which does not undergo obvious radial outward expansion deformation under the outward expansion action of the expansion balloon 1. Furthermore, the diameter of the drug-delivery balloon 2 is larger than the diameter of the expansion balloon 1, and can form an inward extrusion of the drug-delivery balloon 2 relative to the expansion balloon 1 during the outward expansion process of the expansion balloon 1, so as to enhance the extrusion of the elastic drug storage bag 11b.

[0080] In order to facilitate the microneedle 11a to puncture the capsule of the drug delivery balloon 2, the microneedle 11a includes a pointed cone structure. After the expansion balloon 1 is pressurized and expanded, the microneedle 11a with the pointed cone structure punctures through the water-soluble microneedle hole membrane 23 and is tightly embedded in the microporous permeable membrane 22 of the drug delivery balloon 2.

[0081] Specifically, after the microneedle head 11a with a pointed cone structure pierces through the water-soluble microneedle hole membrane 23, its tip portion penetrates into the interior of the lesion site, and the root portion with a larger diameter is tightly embedded in the microporous permeable membrane 22 of the drug delivery balloon 2, so that the drug delivery balloon 2 and the expansion balloon 1 can be combined into a whole. When the balloons are removed, the shrinkage of the expansion balloon 1 drives the drug delivery balloon 2 to shrink synchronously, which is conducive to the overall removal of the two.

[0082] Furthermore, the height of the microneedle 11a is 800 μm to 1200 μm, and the diameter of the bottom of the drug storage capsule 11b is 200 μm to 400 μm. Although the microneedle 11 is an invasive drug delivery method, it can still be considered as a drug delivery method that does not damage the human body because of its micron-scale volume.

[0083] The internal drug administration form of microneedle 11 puncture does not conflict with the external drug administration form of adhesion and penetration promotion, and they can be used in combination to improve the efficiency of transdermal drug administration.

[0084] By using micron-level microneedles 11, macromolecular drugs can act directly inside the lesion, complementing external drug delivery, jointly improving drug delivery conditions, and maximizing overall drug utilization.

[0085] The drug storage bag 11b includes an elastic bag body with high elasticity. The elastic bag body is bonded to the outer surface of the expansion balloon 1 and can release the liquid medicine contained therein under the dual squeezing of the drug delivery balloon 2 and the expansion balloon 1. Based on the puncture of the water-soluble microneedle hole membrane 23 by the microneedle head 11a, in order to prevent the water-soluble microneedle hole membrane 23 from clogging the microneedle hole 11c, the microneedle hole 11c is arranged on the annular side wall of the microneedle head 11a. Preferably, the microneedle hole 11c is arranged on the annular side wall near the tip of the pointed cone-shaped microneedle head 11a, so that when the microneedle head 11a penetrates the inner side of the lesion, the liquid medicine is released to improve the effect of the medicine.

[0086] The expansion balloon 1 and the drug-delivery balloon 2 are overlapped inside and outside, and the expansion balloon 1 and the drug-delivery balloon 2 are respectively arranged in petals. In the conveying state, the drug-delivery balloon 2 and the expansion balloon 1 are curled and wrapped to wrap the microneedles 11 on the outer surface of the expansion balloon 1 to prevent them from piercing the capsule body of the drug-delivery balloon 2 during the conveying process.

[0087] It should be pointed out that the balloon structure in the wrapped state does not affect the corresponding relationship between the positions of the microneedle 11 and the microporous membrane 22. The outer tube can be connected to the inner and outer balloons in a relative state so that the inner and outer balloons can restore the corresponding relationship in the process of inflation and extension.

[0088] The outer tube is arranged at the proximal end of the drug-binding balloon, and a drug storage control ring 6 is connected between the drug-binding balloon and the outer tube. The drug storage control ring 6 mainly plays the role of storing drugs and controlling drug feeding. Specifically, the drug storage control ring 6 includes a drug storage ring cavity 63 located inside, and the drug storage ring cavity 63 is communicated with the drug delivery cavity 3, so that the delivered drug can enter the drug delivery cavity 3 through the drug storage ring cavity 63.

[0089] The outer tube includes a drug delivery lumen 31 for supplying drugs to the drug delivery lumen 3, and the drug delivery lumen 31 communicates with the drug storage annular lumen 63. When administering drugs, drugs can be injected into the drug delivery lumen 31 through an external syringe, and further administered into the drug storage annular lumen 63.

[0090] The drug storage control ring 6 includes at least one axial length, which can ensure the drug storage space of the drug storage ring cavity 63. Combined with the microporous permeable membrane 22 set on the cavity wall of the drug delivery cavity 3, it can achieve the drug storage sustained release effect, so that this part of the drug is sustained-released on the surface of the lesion site.

[0091] Two diaphragm valve plates 62 are arranged opposite to each other at the proximal end of the drug storage ring cavity 63. Each diaphragm valve plate 62 includes a semicircular ring structure. The two diaphragm valve plates 62 can be staggered and overlapped to seal and isolate the drug storage ring cavity 63 from the drug administration lumen 31. During drug administration, the diaphragm valve plates 62 are double-opened under the action of external pressure to allow the drug in the drug administration lumen to enter the drug storage ring cavity.

[0092] The diaphragm valve plate 62 is connected to the inner wall of the outer tube, and a return spring 61 is arranged between the connection roots of the outer tube and the diaphragm valve plate 62. The return spring 61 has an elastic tendency to force the diaphragm valve plate 62 to overlap alternately. Through this arrangement, after stopping the drug administration, the return spring 61 tends to overlap the double-opened diaphragm valve plate 62 alternately, thereby closing the drug inlet channel. Further combined with the drug storage pressure of the previous drug administration, the drug is slowly released through the microporous permeable membrane 22 under the action of the drug storage pressure, and the drug can act on the lesion position of the blood vessel without loss.

[0093] From the perspective of ultrasonic operation, the sound-conducting liquid cavity 4 is sealed and isolated from the drug delivery cavity 3, that is, the sound-conducting liquid in the sound-conducting liquid cavity 4 and the drug in the drug delivery cavity 3 do not affect each other. The inner tube 7 runs through the overall axial direction of the sound-conducting liquid cavity 4 to provide an installation basis for the electrode ring 92. At the same time, the outer surface of the inner tube 7 is sleeved with a developing marking ring 71, which can facilitate the overall marking and positioning of the drug-binding balloon.

[0094] The electrode rings 92 include a plurality of electrode rings 92, which are respectively sleeved on the outer wall of the inner tube 7 and are evenly spaced in the length direction of the inner tube 7. The uniformity of ultrasonic distribution can be enhanced by using a plurality of evenly spaced electrode rings 92, which is conducive to maximizing the utilization of the mechanical energy generated by ultrasonic waves.

[0095] The outer tube includes a pressurized tube cavity 41 for filling the sound-conducting liquid cavity 4 with sound-conducting liquid. The pressurized tube cavity 41 is connected to the sound-conducting liquid cavity 4. Each electrode ring 92 is electrically connected to the electrode plug 91 through an electrode wire 93. The electrode plug 91 is arranged on the proximal outside of the pressurized tube cavity 41 to facilitate connection with the ultrasonic generator 9.

[0096] A temperature sensor 96 is provided in the acoustic liquid chamber 4, and the temperature sensor 96 is electrically connected to the electrode plug 91 through the sensing wire 94. The electrode wire 93 and the sensing wire 94 extend outward through the charging tube chamber 41. The electrode wire 93 and the sensing wire 94 are relatively insulated from each other, and are also relatively insulated from the filled acoustic liquid to avoid electrical interference. The electrode plug 91 is pluggable and installed on the ultrasonic generator 9, which is convenient for external docking and operation.

[0097] During the ultrasonic operation, the temperature of the ultrasonic generator 9 is set to 37-42°C, which is controlled by the timer 95 set on the ultrasonic generator 9. The temperature sensor 96 can transmit the detected sound-conducting liquid temperature to the control unit of the ultrasonic generator 9 through the electrode plug 91. If the temperature exceeds the set temperature, the control unit controls to turn off the ultrasonic generator 9 and stop the ultrasonic operation in time.

[0098] The ultrasonic generator 9 setting parameters are as follows:

[0099] 1) Frequency: Low-frequency ultrasound (20kHz-3MHz) is usually selected. Low-frequency ultrasound has strong penetrating power and significant mechanical effect, and can effectively cause microbubble oscillation and pore-forming effect in the sound-conducting liquid.

[0100] 2) Intensity: Low to medium intensity (0.5-2W / cm 2 ) is commonly used for drug delivery. Too high an intensity may cause thermal effects and tissue damage, while too low an intensity may not effectively activate the microbubbles in the acoustic-conducting fluid and enhance drug penetration.

[0101] 3) Pulsed mode: Pulsed ultrasound is not a continuous wave and is often used for drug delivery because it can reduce heat accumulation while maintaining effective mechanical effects.

[0102] 4) Duration: Set the duration of ultrasound action to ensure that the drug can fully penetrate into the vascular endothelium and the lesion site, and adjust it according to the specific treatment needs and patient conditions.

[0103] The proximal end of the outer tube is connected to a Y-shaped catheter seat 8, which is provided with a drug delivery port and a pressure charging port. The drug delivery port is communicated with the drug delivery lumen, and the pressure charging port is communicated with the pressure charging lumen 41. Normal pressure charging and drug delivery operations can be performed by improving the Y-shaped catheter seat 8.

[0104] The microneedle ultrasonic self-perfusion drug balloon in the present invention can achieve integrated, portable and precise drug delivery during treatment through the microneedle 11. In addition, the microneedle 11 is integrated with the micro-machined drug delivery chamber 3 module, combined with ultrasonic operation, to achieve intelligent and multifunctional integration of the drug system.

[0105] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0106] The above description is only the preferred embodiment of the present application and is not intended to limit the present application. For those skilled in the art, the present application may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A microneedle ultrasonic self-infusion drug balloon, characterized in that: include: A drug-combined balloon, the drug-combined balloon comprising a separately arranged drug-delivery balloon and an expansion balloon, the drug-delivery balloon being arranged outside the expansion balloon, and the gap between the expansion balloon and the drug-delivery balloon constituting a drug-delivery cavity of the drug-combined balloon; The expansion balloon is provided with a microneedle, the capsule body of the drug administration balloon includes a microporous permeable membrane, a water-soluble microneedle pore membrane is provided on the microporous permeable membrane, and the microneedle and the water-soluble microneedle pore membrane are opposite to each other in the radial direction of the drug binding balloon; After the expansion balloon is pressurized and expanded, the microneedles can pierce the water-soluble microneedle pore membrane and protrude and expose on the outer surface of the drug delivery balloon; The microneedle comprises a drug storage bag and a microneedle head with a hollow structure, the drug storage bag is filled with drugs, the microneedle head is connected to the space of the drug storage bag and a microneedle hole is arranged on the microneedle head; The expansion balloon comprises a sound-conducting liquid cavity, the sound-conducting liquid cavity is penetrated by an inner tube, an electrode ring is arranged on the inner tube, the electrode ring is connected to an electrode plug through a wire, and the electrode plug is externally connected to an ultrasonic generator; The distal tube opening of the inner tube is arranged at the balloon tip of the drug-integrated balloon and communicates with the outside world, and the proximal tube opening is arranged on the outer tube of the drug-integrated balloon and connected to the outer tube at the guide wire opening of the balloon catheter. The outer tube is provided with a self-infusion hole, and the self-infusion hole is arranged at the distal end of the guide wire opening and communicates with the lumen of the inner tube.

2. The microneedle ultrasonic self-infusion drug balloon according to claim 1, characterized in that: The microneedles are arranged on the outer surface of the expansion balloon and in a linear array, including multiple rows arranged in the circumferential direction of the expansion balloon. The microporous membrane includes multiple paths arranged on the drug delivery balloon, and each path of the microporous membrane is opposite to the position of each row of the microneedles.

3. The microneedle ultrasonic self-infusion drug balloon according to claim 1, characterized in that: The expansion balloon comprises a compliant balloon, the drug administration balloon comprises a non-compliant balloon, and the diameter of the drug administration balloon is greater than the diameter of the expansion balloon; The microneedle head comprises a pointed cone-shaped structure. After the expansion balloon is pressurized and expanded, the microneedle head with the pointed cone-shaped structure pierces through the water-soluble microneedle pore membrane and is tightly embedded in the microporous permeable membrane of the drug delivery balloon.

4. The microneedle ultrasonic self-infusion drug balloon according to claim 1, characterized in that: The drug storage bag comprises an elastic bag body, the elastic bag body is bonded to the outer surface of the expansion balloon, and the microneedle hole is arranged on the annular side wall of the microneedle head; The expansion balloon and the medication balloon are overlapped inside and outside, and the expansion balloon and the medication balloon are respectively arranged in petals. In the conveying state, the medication balloon and the expansion balloon are curled and wrapped.

5. The microneedle ultrasonic self-infusion drug balloon according to any one of claims 1 to 4, characterized in that: The outer tube is arranged at the proximal end of the drug-binding balloon, and a drug storage control ring is connected between the drug-binding balloon and the outer tube. The drug storage control ring includes a drug storage ring cavity located inside, and the drug storage ring cavity is communicated with the drug delivery cavity. The outer tube includes a drug delivery lumen for supplying drugs to the drug delivery cavity, and the drug delivery lumen is communicated with the drug storage ring cavity.

6. The microneedle ultrasonic self-infusion drug balloon according to claim 5, characterized in that: The drug storage control ring includes at least one axial length, and two diaphragm valve plates are disposed opposite to each other at the proximal end of the drug storage ring cavity, each diaphragm valve plate includes a semicircular ring structure, and the two diaphragm valve plates can be staggered and overlapped to seal and isolate the drug storage ring cavity from the drug delivery tube cavity; The diaphragm valve plate is connected to the inner side wall of the outer tube, and a return spring is arranged between the connection roots of the outer tube and the diaphragm valve plate. The return spring has an elastic tendency to force the diaphragm valve plate to overlap in a staggered manner.

7. The microneedle ultrasonic self-infusion drug balloon according to claim 5, characterized in that: The sound-conducting liquid cavity is sealed and isolated from the drug delivery cavity, the inner tube runs through the entire axial direction of the sound-conducting liquid cavity, and the electrode rings include a plurality of electrode rings, which are respectively sleeved on the outer side wall of the inner tube and are evenly spaced in the length direction of the inner tube.

8. The microneedle ultrasonic self-infusion drug balloon according to claim 5, characterized in that: The outer tube includes a charging tube cavity for filling the sound-conducting liquid cavity with sound-conducting liquid, the charging tube cavity is connected to the sound-conducting liquid cavity, each of the electrode rings is electrically connected to the electrode plug through an electrode wire, a temperature sensor is arranged in the sound-conducting liquid cavity, the temperature sensor is electrically connected to the electrode plug through a sensing wire, the electrode wire and the sensing wire extend outward through the charging tube cavity, and the electrode plug is pluggably installed on the ultrasonic generator.

9. The microneedle ultrasonic self-infusion drug balloon according to claim 8, characterized in that: The proximal end of the outer tube is connected with a Y-shaped catheter seat, and the Y-shaped catheter seat is provided with a drug delivery port and a pressure charging port, the drug delivery port is communicated with the drug delivery lumen, and the pressure charging port is communicated with the pressure charging lumen.

10. The microneedle ultrasonic self-infusion drug balloon according to claim 1, characterized in that: The ultrasonic generator is provided with a timer, and the frequency of the ultrasonic generator is 20kHz-3MHz, and the intensity is 0.5-2W / cm 2 , output pulse ultrasonic wave; The height of the microneedle is 800 μm to 1200 μm, and the diameter of the bottom of the drug storage capsule is 200 μm to 400 μm; The material of the water-soluble micro-pinhole membrane is any one of polytetrafluoroethylene, polymethyl methacrylate and glass fiber paper; The outer surface of the inner tube is sleeved with a developing marking ring.

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