Microneedle balloon catheter and microneedle balloon catheter system

Abstract

The invention relates to a microneedle balloon catheter and a microneedle balloon catheter system. The microneedle balloon catheter comprises a catheter body, a balloon, a plurality of drug-loading microneedles and electrode pairs. The balloon is arranged at the far end of the catheter body, and an inner cavity of the balloon is communicated with the conveying channel of the catheter body. The plurality of medicine carrying microneedles are connected with the outer wall of the balloon; the balloon is filled with an ionic solution; the electrode pair is positioned on the catheter main body in the balloon and is used for puncturing the ion-carrying solution to generate shock waves. The ion-carrying solution is punctured through the electrode pair so as to discharge and generate shock waves, and the shock waves are conducted to the calcification through the ion-carrying solution and the balloon, so that the calcification generates cracks. Therefore, under the action of dilatation pressure of the balloon, the drug-loaded microneedle which is originally abutted against the calcification can penetrate through cracks on the calcification to penetrate into the blood vessel wall, so that the drug-loaded microneedle is easy to penetrate into the blood vessel wall and then slowly releases drugs to the blood vessel wall, and the treatment effect is improved.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a microneedle balloon catheter and a microneedle balloon catheter system. Background Art

[0002] Lower extremity arteriosclerosis obliterans is often accompanied by hypertension and diabetes, and calcification is usually relatively severe and difficult to treat. In the treatment of calcification, drugs and devices are usually used to act on the artery to inhibit the proliferation of smooth muscle cells. Currently, special balloons on the market, such as chocolate balloons, spiky balloons, scored balloons, cutting balloons, microneedle balloons, etc., have poor treatment effects on calcification, and are prone to induce dissection and have a high perforation risk during treatment at higher pressures.

[0003] Among them, the microneedle balloon can improve the drug utilization rate and prolong the drug release time by pressing the drug-loaded microneedles into the blood vessel wall. However, the microneedle balloon needs to directly act on the blood vessel wall with the drug-loaded microneedles to achieve better treatment effects. In the case of calcification on the blood vessel wall, the calcification becomes an obstacle for the drug-loaded microneedles to reach the blood vessel wall, making it difficult for the drug-loaded microneedles to penetrate the blood vessel wall and affecting the treatment effect. Summary of the Invention

[0004] Based on this, it is necessary to provide a microneedle balloon catheter and a microneedle balloon catheter system for the problem that in the case of calcification on the blood vessel wall, the calcification becomes an obstacle for the drug-loaded microneedles to reach the blood vessel wall, making it difficult for the drug-loaded microneedles to penetrate the blood vessel wall and affecting the treatment effect.

[0005] In the first aspect of this application, a microneedle balloon catheter is provided. The microneedle balloon catheter includes: a catheter body, a balloon, a plurality of drug-loaded microneedles, and an electrode pair;

[0006] The balloon is arranged at the distal end of the catheter body, and the inner cavity of the balloon is communicated with the delivery channel of the catheter body;

[0007] A plurality of drug-loaded microneedles are connected to the outer wall of the balloon;

[0008] The balloon is used to fill with an ionic solution; the electrode pair is located on the catheter body inside the balloon and is used to break down the ionic solution to generate shock waves.

[0009] In one embodiment, the microneedle balloon catheter further includes a base corresponding to each drug-loaded microneedle. The base is fixed to the outer wall of the balloon, and the drug-loaded microneedle is arranged on the corresponding base.

[0010] In one embodiment, the outer surface of the drug-loaded microneedle is coated with a protective layer, and the protective layer is made of a soluble material.

[0011] In one embodiment, the maximum cross-sectional area of the base is greater than or equal to the maximum cross-sectional area of the drug-loaded microneedle.

[0012] In one embodiment, the base is provided with a card slot, and the drug-loaded microneedle is snap-fitted into the card slot. The card slot has an opening facing away from the balloon, and the opening is used for the drug-loaded microneedle to move out.

[0013] In one embodiment, the microneedle balloon catheter further includes a thermoswelling structure, and the thermoswelling structure is located between the drug-loaded microneedle and the balloon; the heat generated by the electrode pair breaking down the ionic solution can cause the thermoswelling structure to swell, so as to push the drug-loaded microneedle away from the balloon.

[0014] In one embodiment, the microneedle balloon catheter further includes an adhesive material, and the adhesive material is a soluble material; the drug-loaded microneedle can be adhered to the balloon through the adhesive material, and the heat generated by the electrode pair breaking down the ionic solution and the shock wave can promote the dissolution of the adhesive material, so that the drug-loaded microneedle can be separated from the balloon.

[0015] In one embodiment, the adhesive material is a water-soluble material, and the water-soluble material is any one or a combination of hyaluronic acid, carboxymethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, dextran, chondroitin sulfate, etc.

[0016] In one embodiment, the number of the electrode pairs is multiple pairs, and all the electrode pairs are arranged at intervals in sequence along the axial direction of the catheter body.

[0017] In one embodiment, the catheter body includes an inner tube and an outer tube, the inner tube is inserted through the outer tube, and the distal end of the inner tube extends out of the distal end of the outer tube; the balloon is sleeved on the part of the inner tube extending out of the distal end of the outer tube, and the distal end of the balloon is hermetically connected to the distal end of the inner tube, and the proximal end of the balloon is hermetically connected to the distal end of the outer tube.

[0018] In one embodiment, the microneedle balloon catheter further includes a wire, the wire is inserted through the catheter body, the distal end of the wire is connected to the electrode pair, and the proximal end of the wire is used for electrical connection with a generating power source.

[0019] In one embodiment, the microneedle balloon catheter further includes a connection seat, and the connection seat includes a main pipe and a wiring branch pipe. The main pipe is connected to the proximal end of the catheter body; one end of the wiring branch pipe is connected to the side wall of the main pipe, and the other end of the wiring branch pipe is provided with a first electrical connection structure, and the first electrical connection structure is electrically connected to the proximal end of the wire and is used for accessing the generating power source.

[0020] The second aspect of the present application provides a microneedle balloon catheter system, which includes the microneedle balloon catheter as described in any of the above embodiments and a generating power source; the generating power source is located outside the balloon and the catheter body and is electrically connected to the electrode pair, and the generating power source is used to drive the electrode pair to break down the ionic solution.

[0021] When the above-mentioned microneedle balloon catheter and microneedle balloon catheter system are in use, the microneedle balloon catheter is implanted into a human blood vessel, and the electrode pair is electrically connected to the generating power source. An ionic solution can be filled into the balloon through the delivery channel of the catheter body to expand the balloon to a set pressure, so that the drug-loaded microneedles on the outer wall of the balloon are in contact with the calcification. The ionic solution is broken down by the electrode pair to generate a shock wave through discharge, and the shock wave is conducted to the calcification through the ionic solution via the balloon, so that cracks are generated in the calcification. In this way, under the action of the expansion pressure of the balloon, the drug-loaded microneedles originally in contact with the calcification can penetrate the cracks in the calcification and pierce into the blood vessel wall, making it easier for the drug-loaded microneedles to pierce into the blood vessel wall, and then slowly releasing the drug to the blood vessel wall to improve the treatment effect. It can be seen that through the dual action of the shock wave and the drug-loaded microneedles, the balloon can accurately release the drug to the lesion area under low-pressure expansion, improve the treatment effect, and reduce the operation time. Description of the Drawings

[0022] Figure 1 It is a schematic structural diagram of a microneedle balloon catheter system according to an embodiment.

[0023] Figure 2 It is a schematic diagram when the drug-loaded microneedles of a microneedle balloon catheter according to an embodiment are in contact with the calcification.

[0024] Figure 3 It is a schematic diagram when the drug-loaded microneedles of a microneedle balloon catheter according to an embodiment penetrate the calcification and pierce into the blood vessel wall.

[0025] Figure 4 For Figure 3 A partial enlarged view of area A in

[0026] Figure 5 It is a schematic diagram of the connection relationship of the base, adhesive material, drug-loaded microneedles and protective layer according to an embodiment.

[0027] Figure 6 It is a schematic diagram of the connection relationship of the base, thermally swellable structure, drug-loaded microneedles and protective layer according to an embodiment.

[0028] Description of the attached drawing reference numerals: 10, blood vessel wall; 20, calcification; 30, crack; 31, channel; 100, inner tube; 200, outer tube; 300, balloon; 400, drug-loaded microneedle; 410, base; 411, card slot; 412, opening; 420, adhesive material; 430, thermally swellable structure; 440, protective layer; 500, electrode pair; 600, generating power supply; 610, cable; 710, main pipe; 720, wiring branch pipe; 730, infusion branch pipe. Detailed implementation manners

[0029] To make the above objects, features, and advantages of the present application more obvious and understandable, the following will describe the detailed implementation manners of the present application with reference to the accompanying drawings. Many specific details are set forth in the following description to fully understand the present application. However, the present application can be implemented in many other ways different from those described herein. Those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0030] In the description of the present application, it should be understood that if these terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present application.

[0031] In addition, if these terms "first", "second" appear, these terms are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined with "first", "second" may explicitly or implicitly include at least one of such features. In the description of the present application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

[0032] In this application, unless otherwise clearly defined and limited, if terms such as "installed", "connected", "joined", "fixed", etc. appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0033] In this application, unless otherwise clearly defined and limited, if there is a description such as a first feature being "on" or "under" a second feature, its meaning can be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on" the second feature can be that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature is at a higher horizontal level than the second feature. The first feature being "under", "beneath" and "underneath" the second feature can be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature is at a lower horizontal level than the second feature.

[0034] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or there can also be an intermediate element. If an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If so, the terms "vertical", "horizontal", "up", "down", "left", "right" and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation manner.

[0035] In the embodiments of this application, terms such as "distal end" and "proximal end" are used. Among them, the proximal end is the end of each component of the microneedle balloon catheter close to the operator, and the distal end refers to the other end opposite to the proximal end.

[0036] Please refer to Figure 1 , an embodiment of this application provides a microneedle balloon catheter, which includes: a catheter body, a balloon 300, a plurality of drug-loaded microneedles 400 and at least a pair of electrode pairs 500. The balloon 300 is disposed at the distal end of the catheter body. The inner cavity of the balloon 300 is in communication with the delivery channel of the catheter body. A plurality of drug-loaded microneedles 400 are connected to the outer wall of the balloon 300. An ionic solution (not shown) is used to be filled in the balloon 300, and the electrode pair 500 is located on the catheter body inside the balloon 300 and is used to break down the ionic solution to generate shock waves.

[0037] When the above-mentioned microneedle balloon catheter is used, it is implanted into the human blood vessel, and the electrode pair 500 is electrically connected to the power generator 600. Combining Figures 2 to 4 , an ionic solution can be filled into the balloon 300 through the delivery channel of the catheter body to expand the balloon 300 to a set pressure, so that the drug-loaded microneedles 400 on the outer wall of the balloon 300 are in contact with the calcification 20. The power generator 600 can drive the electrode pair 500 to break down the ionic solution to generate a shock wave by discharging. The shock wave is conducted to the calcification 20 through the ionic solution via the balloon 300, so that cracks 30 are generated in the calcification 20. Thus, under the action of the expansion pressure of the balloon 300, the drug-loaded microneedles 400 originally in contact with the calcification 20 can penetrate the cracks 30 in the calcification 20 and pierce into the blood vessel wall 10, so that the drug-loaded microneedles 400 are easy to pierce into the blood vessel wall 10, and then slowly release drugs to the blood vessel wall 10 to improve the treatment effect. It can be seen that through the dual action of the shock wave and the drug-loaded microneedles 400, the balloon 300 can accurately release drugs to the lesion area under low-pressure expansion, improve the treatment effect, and reduce the operation time.

[0038] It can be understood that the electrode pair 500 includes a positive electrode and a negative electrode arranged at intervals. The positive electrode and the negative electrode are respectively electrically connected to the positive and negative poles of the power generator 600, so that the power generator 600 can apply a voltage to the positive electrode and the negative electrode to break down the ionic solution between the positive electrode and the negative electrode, and then discharge to generate a shock wave. Among them, the specific structures and arrangement manners of the positive electrode and the negative electrode can refer to the prior art and will not be elaborated here.

[0039] Before implanting the microneedle balloon catheter into the blood vessel, a protection umbrella can be pre-implanted into the blood vessel so that the protection umbrella is located at the distal end of the microneedle balloon catheter. Thus, when the shock wave impacts the calcification 20 to generate cracks 30, if there is exfoliated calcification, it can be recovered by the protection umbrella to prevent the exfoliated calcification from falling to the distal end of the blood vessel. The structure and working principle of the protection umbrella can adopt the prior art and will not be elaborated here.

[0040] The drug-loaded microneedles 400 have the property of being biodegradable and can be autonomously degraded without residue after continuously releasing drugs. The drugs loaded in the drug-loaded microneedles 400 are, for example, rapamycin, paclitaxel, etc.

[0041] The materials used for the drug-loaded microneedles 400 are, for example, materials with certain flexibility such as gelatin, chitosan, sodium alginate, polyethylene glycol, PLGA (poly(lactic-co-glycolic acid)), PCL (Polycaprolactone), PMMA (Polymethyl Methacrylate), PGA (Polyglycolide acid), PLA (polylactic acid), PEA (poly(ester amide)), PDLA (Poly(D-lactide)), PLLA (Poly-L-lactic acid), PDLLA (Poly(D,L-lactide)), hyaluronic acid, etc. The flexibility can yield and deform during the implantation process of the microneedle balloon catheter to avoid damaging the blood vessels.

[0042] Please refer to Figure 1 , in one embodiment, the catheter body includes an inner tube 100 and an outer tube 200. The inner tube 100 is disposed through the outer tube 200, and the distal end of the inner tube 100 extends out of the distal end of the outer tube 200. The balloon 300 is sleeved on the part of the inner tube 100 that extends out of the distal end of the outer tube 200, and the distal end of the balloon 300 is hermetically connected to the distal end of the inner tube 100, and the proximal end of the balloon 300 is hermetically connected to the distal end of the outer tube 200.

[0043] In other embodiments, the catheter body can also be in other forms, and no limitation is made thereto.

[0044] In one embodiment, the microneedle balloon catheter further includes a wire (not shown). The wire is disposed through the catheter body, and the distal end of the wire extends into the balloon 300 and is connected to the electrode pair 500, and the proximal end of the wire extends out of the outer tube 200 and is used for electrically connecting to the generating power source 600. In some of these embodiments, the wire can be disposed between the outer tube 200 and the inner tube 100.

[0045] It can be understood that the positive electrode and the negative electrode of the electrode pair 500 can be electrically connected to the generating power source 600 through their respective corresponding wires.

[0046] Please refer to Figure 1 , in one embodiment, the microneedle balloon catheter further includes a connection base. The connection base includes a main pipe 710 and a wiring branch pipe 720. The main pipe 710 is connected to the proximal end of the catheter body. One end of the wiring branch pipe 720 is connected to the side wall of the main pipe 710, and the other end of the wiring branch pipe 720 is provided with a first electrical connection structure (not shown). The first electrical connection structure is electrically connected to the proximal end of the wire and is used for connecting to the generating power source 600.

[0047] When the microneedle balloon catheter is in use, the cable 610 of the power generator 600 is electrically connected to the first electrical connection structure. Also, since the first electrical connection structure is electrically connected to the proximal end of the wire, the power generator 600 is electrically connected to the electrode pair 500 via the cable 610, the first electrical connection structure, the wire, thus facilitating the electrical connection between the power generator 600 and the electrode pair 500.

[0048] Specifically, a second electrical connection structure is provided at the end of the cable 610. The second electrical connection structure is in plug-in fit with the second electrical connection structure. For example, one of the second electrical connection structures is a plug and the other is a socket. Thus, it is convenient to electrically connect the power generator 600 and the electrode pair 500.

[0049] In other embodiments, the first electrical connection structure is not limited to a plug and a socket, as long as it can electrically connect the cable 610 and the wire.

[0050] Please refer to Figure 1 , in one embodiment, the microneedle balloon catheter further includes a connection seat, and the connection seat includes a main pipe 710 and an infusion branch pipe 730. The main pipe 710 is connected to the proximal end of the catheter body and communicates with the infusion channel. The infusion branch pipe 730 is connected to the side wall of the main pipe 710. In this way, the infusion branch pipe 730 is used to connect with an infusion device (such as a syringe, etc.), so that an ionic solution can be input into the main pipe 710 through the infusion branch pipe 730, and the ionic solution enters the inner cavity of the balloon 300 through the main pipe 710 and into the infusion channel. Conversely, when it is necessary to relieve the pressure of the balloon 300, the ionic solution can be extracted from the infusion branch pipe 730, and then the ionic solution is drawn away from the infusion branch pipe 730 after entering the main pipe 710 from the balloon 300 through the infusion channel.

[0051] In other embodiments, the infusion branch pipe may not be provided, and the ionic solution can be input and extracted from the main pipe.

[0052] Please refer to Figure 1 , in one embodiment, the proximal end of the inner tube 100 extends out of the proximal end of the outer tube 200. The main pipe 710 is sleeved on the part where the proximal end of the inner tube 100 extends out of the proximal end of the outer tube 200. The proximal end of the main pipe 710 is hermetically connected to the proximal end of the outer tube 200, and the distal end of the main pipe 710 is hermetically connected to the proximal end of the inner tube 100.

[0053] Please refer to Figure 1, in one embodiment, the number of electrode pairs 500 is multiple pairs, and all the electrode pairs 500 are arranged at intervals in sequence along the axial direction of the catheter body. When the microneedle balloon catheter is implanted into a blood vessel, the axial direction of the catheter body is the length direction of the blood vessel. By arranging multiple pairs of electrode pairs 500 along the axial direction, shock waves can be generated within a relatively long range in the length direction of the blood vessel, so that calcifications within a relatively long range in the length direction of the blood vessel can be impacted to generate cracks, and further, more drug-loaded microneedles 400 can be inserted into the blood vessel wall, improving the treatment effect.

[0054] In some embodiments, the electrode pairs 500 are arranged on the inner tube 100.

[0055] Please refer to Figure 3 and Figure 4 , in one embodiment, the microneedle balloon catheter further includes bases 410 corresponding one-to-one to the drug-loaded microneedles 400. The bases 410 are fixed to the outer wall of the balloon 300, and the drug-loaded microneedles 400 are arranged on the corresponding bases 410.

[0056] After the shock wave is conducted to the calcification 20 through the ionic solution via the balloon 300, causing the calcification 20 to generate cracks 30, under the expansion pressure of the balloon 300, the drug-loaded microneedles 400 originally in contact with the calcification can penetrate through the cracks 30 in the calcification and insert into the blood vessel wall 10. Among them, during the process of the drug-loaded microneedles 400 passing through the cracks 30, the bases 410 simultaneously expand the cracks 30 to form channels 31 and get stuck at the channels 31, thereby providing a moving channel for the drug-loaded microneedles 400 and reducing the resistance when the drug-loaded microneedles 400 pass through the cracks 30. At the same time, under the expansion pressure of the balloon 300, the bases 410 can push the drug-loaded microneedles 400 to penetrate through the cracks 30 and insert into the blood vessel wall 10.

[0057] Figure 4 As shown, the thickness of the calcification 20 is relatively thin. For the case where the calcification 20 is relatively thick, the dimension of the base 410 in the thickness direction of the calcification 20 can be adjusted so that the thickness of the base 410 also increases, so that the base 410 can still push the drug-loaded microneedles 400 to penetrate through the cracks 30 and insert into the blood vessel wall 10.

[0058] The materials used for the base 410 are, for example, materials with certain flexibility such as gelatin, chitosan, sodium alginate, polyethylene glycol, PLGA (poly(lactic-co-glycolic acid)), PCL (Polycaprolactone), PMMA (Polymethyl Methacrylate), PGA (Polyglycolide acid), PLA (polylactic acid), PEA (poly(ester amide)), PDLA (Poly(D-lactide)), PLLA (Poly-L-lactic acid), PDLLA (Poly(D,L-lactide)), hyaluronic acid, etc. The flexibility can cause yield deformation during the implantation of the microneedle balloon catheter to avoid damaging the blood vessel.

[0059] Please refer to Figure 3 and Figure 4 , in one embodiment, the maximum cross-sectional area of the base 410 is greater than or equal to the maximum cross-sectional area of the drug-loaded microneedle 400, so that the channel 31 formed when the base 410 spreads the crack 31 can be larger, making it easier for the drug-loaded microneedle 400 to pass through.

[0060] In the embodiments of the present application, the cross-section of the base 410 refers to the section in the base 410 parallel to the axial direction of the catheter body. Correspondingly, the cross-section of the drug-loaded microneedle 400 refers to the section in the drug-loaded microneedle 400 parallel to the axial direction of the catheter body.

[0061] In Figure 4 the shown embodiment, along the direction in which the drug-loaded microneedle 400 pierces the blood vessel wall 10, the cross-sectional area of the base 410 is tapered, so that the cross-sectional area at the connection between the base 410 and the balloon 300 is the maximum cross-sectional area of the base 410, and the connection between the base 410 and the balloon 300 is reliable.

[0062] In Figure 4 the shown embodiment, along the direction in which the drug-loaded microneedle 400 pierces the blood vessel wall 10, the cross-sectional area of the drug-loaded microneedle 400 is tapered, so that the end thereof piercing the blood vessel wall 10 is a tip, and the cross-sectional area at the connection between the drug-loaded microneedle 400 and the base 410 is the maximum cross-sectional area of the drug-loaded microneedle 400.

[0063] In other embodiments, along the direction in which the drug-loaded microneedle pierces the blood vessel wall, the cross-sectional area of the base can also be uniform.

[0064] Please refer to Figure 5, in one embodiment, the drug-loaded microneedle 400 can be adhered to the balloon 300 through the adhesive material 420. The heat and shock waves generated by the electrode pair 500 breaking down the ionic solution can promote the dissolution of the adhesive material 420, enabling the drug-loaded microneedle 400 to detach from the balloon 300.

[0065] Specifically, when the power supply 600 drives the electrode pair 500 to break down the ionic solution to discharge and generate shock waves, and the shock waves are conducted to the calcification 20 causing the calcification 20 to generate cracks 30, the heat generated by the electrode pair 500 breaking down the ionic solution and the vibration brought by the shock waves can simultaneously promote the dissolution of the adhesive material 420. The dissolution of the adhesive material 420 can then release the adhesion between the drug-loaded microneedle 400 and the balloon 300. Thus, under the expansion pressure of the balloon 300, after the drug-loaded microneedle 400 penetrates into the blood vessel wall 10, the bonding force between the drug-loaded microneedle 400 and the blood vessel wall 10 can cause the drug-loaded microneedle 400 to detach from the balloon 300.

[0066] Please refer to Figure 5 , in one embodiment, the drug-loaded microneedle 400 is bonded to the base 410 through the adhesive material 420, so that the drug-loaded microneedle 400 is indirectly bonded to the outer wall of the balloon 300.

[0067] In other embodiments, the base may not be provided, and the drug-loaded microneedles may be directly bonded to the outer wall of the balloon.

[0068] In one embodiment, the adhesive material 420 is a water-soluble material with good biocompatibility. For example, hyaluronic acid, carboxymethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, dextran, chondroitin sulfate, etc.

[0069] In other embodiments, the adhesive material may also be a heat-soluble material.

[0070] Please refer to Figure 6 , in one embodiment, the base 410 is provided with a card slot 411, and the drug-loaded microneedle 400 is snap-fitted into the card slot 411. The card slot 411 has an opening 412 facing away from the balloon 300, and the opening 412 is used for the drug-loaded microneedle 400 to move out of the card slot 411. After the calcification 20 generates cracks 30, the drug-loaded microneedle 400 can move out of the card slot 411 from the opening 412 and penetrate into the blood vessel wall 10.

[0071] Make the clamping force between the drug-loaded microneedle 400 and the card slot 411 less than the bonding force between the drug-loaded microneedle 400 and the blood vessel wall 10. After the drug-loaded microneedle 400 penetrates into the blood vessel wall 10, the bonding force between the drug-loaded microneedle 400 and the blood vessel wall 10 is used to cause the drug-loaded microneedle 400 to detach from the card slot 411.

[0072] Please refer to Figure 6, in one embodiment, the microneedle balloon catheter further includes a thermally swellable structure 430. The thermally swellable structure 430 is disposed between the drug-loaded microneedles 400 and the balloon 300. During the process in which the power supply 600 drives the electrode pair 500 to break down the ionic solution to discharge and generate a shock wave, and the shock wave is conducted to the calcification 20 to cause cracks 30 in the calcification 20, the heat generated by the breakdown of the ionic solution by the electrode pair 500 simultaneously causes the thermally swellable structure 430 to swell. Thus, the thermally swellable structure 430 pushes the drug-loaded microneedles 400 away from the balloon 300 and pierces into the blood vessel wall 10. The material of the thermally swellable structure 430 is, for example, ePTFE (expended polytetrafluoroethylene).

[0073] In Figure 6 the illustrated embodiment, the thermally swellable structure 430 is located within the card slot 411 and, after swelling, can push the drug-loaded microneedles 400 out of the card slot 411 from the opening 412 and thus pierce into the blood vessel wall 10.

[0074] In other embodiments, the base may not be provided. Card slots are provided on the outer wall of the balloon, and the drug-loaded microneedles are snap-fitted into the card slots. The drug-loaded microneedles can also move out of the card slots and pierce into the blood vessel wall. In this case, a thermally swellable structure may also be provided within the card slots on the outer wall of the balloon, and the swelling of the thermally swellable structure is used to push the drug-loaded microneedles out of the card slots and thus pierce into the blood vessel wall.

[0075] Please refer to Figure 5 and Figure 6 , in some embodiments, a protective layer 440 is coated outside the drug-loaded microneedles 400, and the protective layer 440 is made of a soluble material. During the process of implanting the microneedle balloon catheter into the blood vessel, since the protective layer 440 coats the drug-loaded microneedles 400, it can prevent the drug-loaded microneedles 400 from stabbing the blood vessel wall. In some of these implementation manners, the outer surface of the protective layer 440 is arc-shaped or spherical.

[0076] The protective layer 440 may specifically adopt a water-soluble material, which has good biocompatibility. For example, hyaluronic acid, carboxymethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, dextran, chondroitin sulfate, etc.

[0077] In some embodiments, by reasonably setting the parameters of the protective layer 440, the protective layer 440 can be made to dissolve before the calcification 20 generates cracks 30, so as to expose the drug-loaded microneedles 400 in a timely manner, such that the drug-loaded microneedles 400 can pass through the cracks 30 in a timely manner after the calcification 20 generates cracks 30. The dissolution rate of the water-soluble material can be adjusted by adjusting the chemical composition and physical structure of the material, so as to achieve the dissolution of the protective layer 440 between the generation of cracks 30 in the calcification 20.

[0078] Please refer to Figure 1, an embodiment of the present application provides a microneedle balloon catheter system, which includes a generating power source 600 and the microneedle balloon catheter of any of the above embodiments. The generating power source 600 is located outside the balloon 300 and the outer tube 200, and the generating power source 600 is electrically connected to the electrode pair 500 for driving the electrode pair 500 to break down the ionic solution.

[0079] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope recorded in this specification.

[0080] The above embodiments only represent several implementation manners of the present application. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several deformations and improvements can be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A microneedle balloon catheter, characterized in that, The microneedle balloon catheter includes: a catheter body, a balloon, a plurality of drug-loaded microneedles, and an electrode pair; The balloon is disposed at the distal end of the catheter body, and the inner cavity of the balloon is communicated with the delivery channel of the catheter body; A plurality of drug-loaded microneedles are connected to the outer wall of the balloon; The balloon is used to be filled with an ionic solution; The electrode pair is located on the catheter body within the balloon and is used to break down the ionic solution to generate shock waves.

2. The microneedle balloon catheter according to claim 1, wherein the microneedle balloon catheter further includes a base corresponding to each drug-loaded microneedle, the base is fixed to the outer wall of the balloon, and the drug-loaded microneedle is disposed on the corresponding base; and / or, a protective layer is coated outside the drug-loaded microneedle, and the protective layer is made of a soluble material.

3. The microneedle balloon catheter according to claim 2, wherein the maximum cross-sectional area of the base is greater than or equal to the maximum cross-sectional area of the drug-loaded microneedle; or, the base is provided with a card slot, the drug-loaded microneedle is clamped in the card slot, the card slot has an opening facing away from the balloon, and the opening is used for the drug-loaded microneedle to move out.

4. The microneedle balloon catheter according to any one of claims 1 to 3, characterized in that, It further includes a thermoswelling structure, and the thermoswelling structure is located between the drug-loaded microneedle and the balloon; the heat generated by the electrode pair breaking down the ionic solution can cause the thermoswelling structure to swell, so as to push the drug-loaded microneedle away from the balloon.

5. The microneedle balloon catheter according to any one of claims 1 to 3, characterized in that, The drug-loaded microneedle can be bonded to the balloon through an adhesive material, and the heat and shock waves generated by the electrode pair breaking down the ionic solution can promote the dissolution of the adhesive material, so that the drug-loaded microneedle can be separated from the balloon.

6. The microneedle balloon catheter according to claim 5, characterized in that, The adhesive material is a water-soluble material, and the water-soluble material is any one or a combination of hyaluronic acid, carboxymethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, dextran, chondroitin sulfate, etc.

7. The microneedle balloon catheter according to claim 1, characterized in that, The number of the electrode pairs is multiple pairs, and all the electrode pairs are arranged at intervals in sequence along the axial direction of the catheter body; and / or, The catheter body includes an inner tube and an outer tube, the inner tube is inserted through the outer tube, and the distal end of the inner tube extends out of the distal end of the outer tube; the balloon is sleeved on the part of the inner tube extending out of the distal end of the outer tube, and the distal end of the balloon is hermetically connected to the distal end of the inner tube, and the proximal end of the balloon is hermetically connected to the distal end of the outer tube.

8. The microneedle balloon catheter according to claim 1, wherein, It further includes a wire, the wire is inserted through the catheter body, the distal end of the wire is connected to the electrode pair, and the proximal end of the wire is used to be electrically connected to a generating power source.

9. The microneedle balloon catheter according to claim 8, wherein It further includes a connector, the connector includes a main pipe and a wiring branch pipe, the main pipe is connected to the proximal end of the catheter body; one end of the wiring branch pipe is connected to the side wall of the main pipe, and the other end of the wiring branch pipe is provided with a first electrical connection structure, and the first electrical connection structure is electrically connected to the proximal end of the wire and is used to access the generating power source.

10. A microneedle balloon catheter system, characterized in that, The microneedle balloon catheter system includes the microneedle balloon catheter according to any one of claims 1 to 9 and a generating power source; the generating power source is located outside the balloon and the catheter body and is electrically connected to the electrode pair, and the generating power source is used to drive the electrode pair to break down the ionic solution.

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