Ultrasonic permeation-promoting self-perfusion medicine balloon catheter and ultrasonic permeation-promoting treatment device

Abstract

The invention relates to an ultrasonic infiltration-promoting self-perfusion medicine balloon catheter and an ultrasonic infiltration-promoting treatment device. The ultrasonic infiltration-promoting self-perfusion medicine balloon catheter comprises a medicine balloon, a balloon catheter body and a medicine conveying system. The drug delivery system comprises a drug release tube, a drug delivery tube and a drug storage ring, and a drug supply balloon is arranged on the outer side of the drug storage ring; the drug release tube is connected to the balloon main body, and nano-scale drug release micropores are uniformly distributed in the drug release tube; the medicine storage ring is annularly hooped on the outer side of the outer tube; the near end of the medicine conveying pipe is connected to the medicine storage ring, and a pipe cavity of the medicine conveying pipe is communicated with a ring cavity of the medicine storage ring. And the medicine supply balloon comprises a non-compliant balloon. According to the invention, the washing loss of medicine particles and the embolism risk caused by the washing loss in the conveying process can be avoided, the absorption of the medicine at the diseased region in the blood vessel can be promoted, the long-time uninterrupted administration can be realized, and the administration amount can be adjusted in a targeted manner according to the specific and actual lesion degree.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an ultrasonic osmosis self-perfusion drug balloon catheter and an ultrasonic osmosis treatment device. 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] The traditional drug delivery method is mainly to spray the drug directly on the balloon surface, and a few have the theory of adhering nano drug-loaded microspheres on the balloon surface. Regardless of the form, there is a problem of drug particles falling off during balloon delivery. At the same time, due to the flushing of blood during delivery, the drug loss rate is very large, and the effective drug reaching the lesion is very low. At the same time, the drug particles that fall off during delivery will also cause distal embolism.

[0004] The drug balloon simply relies on balloon inflation to squeeze the blood vessel wall, sticking the drug to the inner wall of the blood vessel, which is automatically absorbed by the patient. The actual drug content that acts on the lesion is low and the absorption rate is low.

[0005] The expansion time of traditional drug balloons is short, and the drug on the balloon cannot be fully released. At the same time, the drug content on traditional drug balloons is limited and cannot be adjusted according to the specific degree of lesions. Summary of the invention

[0006] The purpose of the present application is to provide an ultrasonic osmosis self-infusion drug balloon catheter and an ultrasonic osmosis treatment device, which can avoid the washout loss of drug particles and the risk of embolism during the delivery process, promote the absorption of drugs in the lesion site in the blood vessel, and can achieve long-term uninterrupted drug administration, and adjust the dosage in a targeted manner according to the specific actual degree of the lesion.

[0007] In order to achieve the above-mentioned object, in a first aspect, the present invention provides an ultrasound-enhanced self-perfusion drug balloon catheter, comprising: a drug balloon, a balloon catheter and a drug delivery system;

[0008] The drug delivery system comprises a drug release tube, a drug delivery tube and a drug storage ring which are arranged in sequence from far to near, and a drug supply balloon is arranged on the outer side of the drug storage ring;

[0009] The drug balloon comprises a balloon body, a distal cone section and a proximal cone section, the drug release tube is connected to the balloon body and extends along the axial direction of the balloon body, and the drug release tube is uniformly distributed with nano-scale drug release micropores;

[0010] The balloon catheter comprises an outer tube, the drug delivery tube is connected to the outer tube and the proximal cone section, and the drug storage ring is arranged at the proximal side of the drug balloon and is an annular clamp on the outer side of the outer tube;

[0011] The proximal end of the drug delivery tube is connected to the drug storage ring, and the lumen of the drug delivery tube is in communication with the annular lumen of the drug storage ring;

[0012] The drug supply balloon comprises a non-compliant balloon, the two ends of which are respectively sealed and connected to the drug storage ring and the outer side wall of the outer tube, the outer tube is provided with a drug delivery cavity, the drug delivery cavity is communicated with the inner cavity of the drug supply balloon, and the drug storage ring is provided with a drug inlet capable of communicating with the inner cavity of the drug supply balloon;

[0013] An inner tube is arranged inside the outer tube, and a plurality of self-infusion holes are arranged between the inner tube and the outer tube, the self-infusion holes are communicated with the lumen of the inner tube, the inner tube passes through the entire length direction of the drug balloon and is communicated with the balloon tip of the drug balloon, and the self-infusion holes are arranged at the proximal side of the drug supply balloon;

[0014] The drug balloon comprises a balloon guide wire cavity and a balloon sound-conducting liquid cavity, and an ultrasonic component is arranged inside the balloon sound-conducting liquid cavity.

[0015] In an optional embodiment, the drug release tube is welded or bonded to the outer wall of the balloon body, the drug delivery tube is welded or bonded to the outer wall of the outer tube and the outer wall of the proximal cone section, and the inner annular wall of the drug storage ring is fully welded and heat-sealed to the outer wall of the outer tube.

[0016] In an optional embodiment, the distal end of the medicine supply balloon is connected to the outer side wall of the medicine storage ring at the proximal end, and the proximal end of the medicine supply balloon is connected to the outer side wall of the outer tube.

[0017] In an optional embodiment, the drug inlet is arranged on the end face of the drug storage ring located on the proximal side, and the drug inlet includes an annular drug inlet, the annular drug inlet is arranged concentrically with the drug storage ring, and the width of the annular drug inlet is not greater than one quarter of the width of the drug storage ring, and a plurality of reinforcing ribs are connected to the end face of the proximal side of the drug storage ring, and the plurality of reinforcing ribs are welded to the outer side wall of the outer tube;

[0018] The proximal end of the reinforcing rib is connected to the connection point of the medicine supply balloon on the outer tube, and the distal end of the reinforcing rib is connected to the end surface of the proximal end of the medicine storage ring and is connected to the radial root of the medicine storage ring where the medicine inlet is not opened.

[0019] In an optional embodiment, the drug release tube and the drug delivery tube are the same pipeline, including a plurality of tubes arranged at intervals, and the plurality of drug release tubes and the drug delivery tubes are evenly distributed around the circumference of the drug balloon.

[0020] In an optional embodiment, the drug release tube, the drug delivery tube and the drug storage ring are made of the same material, including a flexible polymer material, and the diameter of the drug release tube and the drug delivery tube is 30%-100% of the wall thickness of the drug balloon.

[0021] In an optional embodiment, the material of the drug supply balloon includes polyethylene, polyester, polyethylene terephthalate, nylon or polyurethane.

[0022] In an optional embodiment, the ultrasonic component includes one or more groups disposed inside the drug balloon, and each group of the ultrasonic components includes an ultrasonic cable and an ultrasonic electrode sheet;

[0023] The outer tube comprises a cable cavity, and the ultrasound cable extends from the interior of the drug balloon and is connected to an external ultrasound device through the cable cavity.

[0024] In an optional embodiment, the balloon sound-conducting liquid cavity is filled by filling the sound-conducting liquid, and the outer tube includes a pressure-filling cavity for filling the sound-conducting liquid, and the pressure-filling cavity is connected to the balloon sound-conducting liquid cavity;

[0025] The proximal end of the outer tube is connected with an operating joint, and the operating joint includes a charging port, a cable port and a drug filling port. The drug filling port is connected with the drug delivery cavity, the charging port is connected with the charging cavity, and the cable port is connected with the cable cavity.

[0026] In a second aspect, the present invention provides a sono-osmotic treatment device, comprising an ultrasonic device and a sono-osmotic self-perfusion drug balloon catheter as described in any one of the aforementioned embodiments, wherein the ultrasonic device is electrically connected to the ultrasonic component via an ultrasonic cable;

[0027] The proximal end of the inner tube is connected to the outer tube at the guide wire port, the tail end of the guide wire is inserted into the balloon tip and extended out of the guide wire port, and the ultrasound-enhanced self-perfusion drug balloon catheter is sent into the blood vessel through the operating joint under the guidance of the guide wire;

[0028] When the drug balloon reaches the lesion site, the sound-conducting liquid is filled into the drug balloon so that the drug balloon fits the lesion site after being filled, and the liquid drug is pressurized and filled into the drug storage ring through the drug delivery cavity on the outer tube, and the ultrasonic device is turned on;

[0029] Under the pressure of the drug storage ring, drug delivery tube and drug release tube, the filled liquid drug is released at the lesion site through the nano-scale drug release micropores evenly distributed on the drug release tube. At the same time, the ultrasonic wave generated by the ultrasonic component forms temporary micropores on the cell membrane of the lesion site, so that the released liquid drug acts on the lesion site and is absorbed;

[0030] During the treatment, the blood at the proximal end of the drug balloon enters the inner tube through the self-perfusion hole and flows normally from the balloon tip to the distal end downstream of the drug balloon;

[0031] After the treatment is finished, the ultrasonic perfusion liquid in the drug balloon is sucked out, the pressurized drug supply is stopped, and after the drug balloon is deflated, the ultrasonic perfusion drug balloon catheter is completely withdrawn from the blood vessel.

[0032] By setting up a drug delivery system, it is possible to deliver the drug balloon catheter into the blood vessel and then administer the drug before the treatment process. Compared with the traditional method of encapsulating and delivering the drug, it can fundamentally avoid the erosion of the drug by the blood flow and reduce the risk of embolism.

[0033] The drug delivery system includes a drug release tube, a drug delivery tube and a drug storage ring which are arranged in sequence and interconnected, and combined with a non-compliant drug supply balloon arranged on the outside of the drug storage ring, a certain connection drug supply and storage effect can be formed. Through the form of pressurized drug supply in vitro, combined with the drug supply pressure that the non-compliant drug supply balloon can bear, liquid drugs can be stored in the drug supply balloon under static pressure, and a certain drug extrusion pressure can be formed in the drug supply balloon due to the incompressible property of liquid drugs. Further combined with the communication between the drug storage ring and the inner cavity of the drug supply balloon, and the nano-scale drug release micropores of the drug release tube arranged on the balloon body, liquid drugs can be released at the lesion site.

[0034] By circumferentially clamping the drug storage ring on the outside of the outer tube and arranging the drug storage ring on the proximal side of the drug balloon, the drug storage ring can be effectively and stably fixed and installed, while reducing the distance and pressure drop between the drug release tube and the drug storage ring, so that the liquid drug can be efficiently and directly released under the static pressure squeezing of the drug supply balloon.

[0035] The self-perfusion hole set on the balloon catheter can maintain normal blood circulation when the drug balloon is inflated and expanded, thereby ensuring safety during the treatment process.

[0036] By setting a balloon sound-conducting liquid cavity inside the drug balloon and setting an ultrasonic component in the balloon sound-conducting liquid cavity, a good ultrasonic permeation effect can be formed to promote efficient absorption of the drug.

[0037] The ultrasonic osmosis self-perfusion drug balloon catheter in the present invention can continuously supply drugs in the form of pressurized liquid drugs through the drug delivery system, breaking through the factor of limited amount of drugs attached to traditional drug balloons, and combining with the flow form of blood self-perfusion, it can achieve full release of drugs on the balloon under the condition of prolonging the treatment time.

[0038] The use of ultrasound components that promote penetration can promote the absorption of drugs in blood vessels and increase the effectiveness of drugs in lesions.

[0039] Other features and advantages of the present application will be described in detail in the subsequent specific implementation section. 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 structure of the ultrasonic osmosis self-perfusion drug balloon catheter of this application;

[0042] Figure 2 It is a schematic diagram of the structure of the drug release tube on the drug balloon;

[0043] Figure 3 It is a schematic structural diagram of the proximal end surface of the drug storage ring;

[0044] Figure 4 It is a schematic diagram of the structure of the ultrasound component on the drug balloon;

[0045] Figure 5 Schematic diagram of the cross-sectional structure of the outer tube.

[0046] icon:

[0047] 1-drug balloon; 11-balloon body; 12-distal cone section; 13-proximal cone section; 14-balloon tip; 15-balloon acoustic liquid cavity;

[0048] 2-drug release tube; 21-drug release micropore;

[0049] 3-Drug delivery tube;

[0050] 4-drug storage ring; 41-drug inlet; 42-reinforcement rib;

[0051] 5-Medication balloon;

[0052] 6-outer tube; 61-drug delivery cavity; 62-cable cavity; 63-pressurization cavity;

[0053] 7-inner tube; 71-self-infusion hole; 72-balloon guidewire cavity;

[0054] 8-ultrasound component; 81-ultrasound cable; 82-ultrasound electrode sheet;

[0055] 9-operating connector; 91-charging port; 92-cable port; 93-medicine filling port. DETAILED DESCRIPTION

[0056] 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.

[0057] 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.

[0058] 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.

[0059] The ultrasound-enhanced self-perfusion drug balloon catheter in this application is used in the treatment of cardiovascular diseases. It mainly provides a necessary drug delivery system and combines it with the continuous supply of liquid drugs. It can administer drugs after the drug balloon catheter enters the blood vessel, and can prolong the treatment time and enhance the drug permeation effect.

[0060] See also Figure 1 , and combined with Figure 2 The ultrasonic osmosis self-perfusion drug balloon catheter of the present invention has a main structure comprising: a drug balloon 1, a balloon catheter and a drug delivery system;

[0061] The drug delivery system comprises a drug release tube 2, a drug delivery tube 3 and a drug storage ring 4 which are arranged in sequence from far to near, and a drug supply balloon 5 is arranged on the outer side of the drug storage ring 4;

[0062] The drug storage ring 4 and the drug supply balloon 5 are arranged on the outer tube 6 , and are mainly used to provide the functions of pressurized drug supply and static pressure storage and drug administration, so that the pressurized liquid drug is connected and buffered in the drug supply balloon 5 and the drug storage ring 4 .

[0063] The drug release tube 2 and the drug delivery tube 3 are connected between the drug balloon 1 and the drug storage ring 4. Specifically, the drug release tube 2 and the drug delivery tube 3 are the same pipeline, which is mainly used to transmit and release the liquid drug with a certain static pressure in the drug supply balloon 5 and the drug storage ring 4.

[0064] The drug balloon 1 includes a balloon body 11, a distal cone section 12 and a proximal cone section 13. The drug release tube 2 is connected to the balloon body 11. After the drug balloon 1 is pressurized and expanded, the balloon body 11 can correspond to the lesion site and make the drug release tube 2 fit the lesion site.

[0065] The drug release tube 2 extends axially along the balloon body 11, and can be in contact with the lesion site in a linear form protruding from the outer wall of the balloon body 11. By evenly distributing nanoscale drug release micropores 21 on the drug release tube 2, the liquid drug can be released at the lesion site under the squeezing force of static pressure.

[0066] The balloon catheter includes an outer tube 6 , and the drug delivery tube 3 is connected to the outer tube 6 and the proximal cone section 13 to achieve the connection of the drug delivery tube 3 .

[0067] The drug storage ring 4 is arranged at the proximal side of the drug balloon 1 and is an annular hoop on the outside of the outer tube 6. By arranging the drug storage ring 4 at the proximal side of the drug balloon 1, that is, arranging the drug storage ring 4 at the proximal side close to the drug balloon 1, the distance between the drug storage ring 4 and the drug delivery tube 3 and the drug release tube 2 can be reduced, and the pressure loss from the drug storage ring 4 to the drug delivery tube 3 can be reduced accordingly, which can maximize the effect of drug release and enable the liquid drug to be fully released under the static pressure of the drug supply balloon 5 and the drug storage ring 4. At the same time, the annular hoop of the drug storage ring 4 is on the outside of the outer tube 6, which can ensure the stable installation of the drug storage ring 4.

[0068] The proximal end of the drug delivery tube 3 is connected to the drug storage ring 4, and the lumen of the drug delivery tube 3 is communicated with the annular lumen of the drug storage ring 4, forming a phase sequence communication of the pressure space.

[0069] Based on the above-mentioned ability of the drug supply balloon 5 to bear the pressure of external pressurized drug administration and to provide static pressure for drug supply to the downstream, the drug supply balloon 5 includes a non-compliant balloon. The function of the non-compliant balloon is to exert its ability to not undergo elastic deformation after being pressurized and to generate a strong static pressure.

[0070] In order to form an effective static pressure space, the two ends of the medicine supply balloon 5 are respectively closed and connected to the outer side walls of the medicine storage ring 4 and the outer tube 6. At the same time, a drug delivery cavity 61 is provided on the outer tube 6. By connecting the drug delivery cavity 61 with the inner cavity of the medicine supply balloon 5, combined with the incompressibility of liquid drugs, it is possible to convert external pressurized drug supply into static pressure drug delivery of the medicine supply balloon 5. By providing a drug inlet 41 on the medicine storage ring 4 that can communicate with the inner cavity of the medicine supply balloon 5, the internal ring cavity of the medicine storage ring 4 can maintain the same static pressure drug delivery pressure as that of the inner cavity of the medicine supply balloon 5, thereby facilitating the formation of static pressure extrusion of the drug delivery tube 3 and the drug release tube 2.

[0071] The balloon catheter also includes an inner tube 7 arranged inside the outer tube 6, and a plurality of self-infusion holes 71 are arranged between the inner tube 7 and the outer tube 6, and the self-infusion holes 71 are communicated with the lumen of the inner tube 7. After the inner tube 7 passes through the entire length direction of the drug balloon 1, it is connected to the balloon tip 14 of the drug balloon 1. Through this arrangement, the self-infusion effect of the drug balloon catheter in the present application is constituted. After the drug balloon 1 is inflated and expanded, the blood at the proximal end of the drug balloon 1 can flow into the inner tube 7 through the plurality of self-infusion holes 71 and flow out from the balloon tip 14 to the distal downstream of the drug balloon 1, thereby maintaining normal blood flow during treatment and reducing the risk of discomfort to the patient.

[0072] By arranging the self-perfusion hole 71 at the proximal side of the medicine supplying balloon 5 , the risk of the medicine supplying balloon 5 occupying a position in the blood vessel and affecting the blood flow can be avoided, while the blood not affected by the medicine supplying balloon 5 can flow into the self-perfusion hole 71 sufficiently and smoothly.

[0073] The balloon guidewire cavity 72 included in the drug balloon 1 can allow the guidewire to pass through, ensuring the guiding insertion of the entire drug balloon catheter.

[0074] At the same time, the balloon sound-conducting liquid cavity 15 can be expanded by filling it with sound-conducting liquid. Combined with the ultrasonic component 8 arranged inside the balloon sound-conducting liquid cavity 15, it can have an ultrasonic permeation effect on the liquid medicine acting on the lesion site.

[0075] From the perspective of mechanism, in the process of ultrasonic penetration, the present invention mainly uses the cavitation effect of ultrasound. The cavitation effect is that under the action of ultrasound, the vibration of cavitation bubbles at the interface of corneocytes and lipid molecular layers causes the vibration of the lipid bilayer of the stratum corneum, and at the same time, the shock wave generated by the rupture of cavitation bubbles at the interface will cause the disorder of the arrangement of lipids in the stratum corneum. The vibration of cavitation bubbles can penetrate a large amount of water into the disordered lipid area to form aqueous channels, and the drug diffuses faster through these channels.

[0076] Ultrasound-assisted drug delivery is used in tumor treatment. By increasing the permeability of chemotherapy drugs at the tumor site through ultrasound, the drug's killing effect on tumor cells can be improved and the side effects on healthy cells can be reduced.

[0077] The ultrasonic component 8 in the present invention uses ultrasound to enhance the permeability of the released liquid drug to act on the lesion site. The combination of precise ultrasound parameter settings and microbubble technology of "ultrasound-assisted drug delivery" in the vascular endothelium can significantly improve the local penetration and therapeutic effect of the drug.

[0078] The drug delivery system is completely carried out in independent structural pipelines and different cavities during the delivery process, which avoids drug loss and drug particles falling off in the human body to form blood clots, and improves the effective utilization rate and safety of drugs.

[0079] Ultrasonic waves can form temporary micropores on the cell membrane, making it easier for the liquid drug released by the drug release tube 2 to enter the cells at the lesion site. This increases the concentration of the drug in the target cells and enhances the therapeutic effect. The microbubbles in the sound-conducting liquid will vibrate and rupture under the action of ultrasound (200-2000kpa). The shock waves and microjets generated during the rupture can increase the permeability of tissues and cells and promote the entry of drugs into cells.

[0080] Under the action of ultrasound, microbubbles in the sound-conducting liquid will vibrate and burst, and the shock waves and micro-jets generated during the bursting will act precisely on the lesion location. Under the joint action of the ultrasound device, the microbubbles will burst, and the shock waves generated will act on the liquid drug released by the drug release tube 2, making it act precisely on the lesion location, greatly improving the drug absorption rate.

[0081] Combination Figure 2-Figure 3 In one specific embodiment, in order to fix the drug release tube 2 and the drug delivery tube 3 on the drug balloon 1 and part of the outer tube 6, the drug release tube 2 is welded or bonded to the outer wall of the balloon body 11, and the drug delivery tube 3 is welded or bonded to the outer wall of the outer tube 6 and the outer wall of the proximal cone section 13, preferably a welding connection.

[0082] Based on the closed connection between the distal end of the medicine supply balloon 5 and the outer wall of the medicine storage ring 4, and the annular clamp of the medicine storage ring 4 on the outer tube 6, in order to enable the medicine supply balloon 5 to form a relatively sealed balloon space and prevent leakage in the gap between the medicine storage ring 4 and the outer tube 6, the inner annular wall of the medicine storage ring 4 and the outer wall of the outer tube 6 are fully welded and heat-sealed. Through this arrangement, the pressure-bearing performance of the medicine supply balloon 5 can be guaranteed to the greatest extent.

[0083] The connection angle of the medicine supply balloon 5 is such that the distal end of the medicine supply balloon 5 is connected to the outer side wall of the medicine storage ring 4 at the proximal end, and the proximal end of the medicine supply balloon 5 is connected to the outer side wall of the outer tube 6 .

[0084] Specifically, the proximal end of the medicine supply balloon 5 is connected to the outer side wall of the outer tube 6, which can ensure the sealing reliability in the form of annular contact. The distal end of the medicine supply balloon 5 is connected to the outer side wall of the medicine storage ring 4 at the proximal end mainly from two aspects.

[0085] First, from the perspective of being able to reliably form a sealed connection, by welding the distal annular surface of the drug supply balloon 5 to the annular surface of the outer wall of the drug storage ring 4 at the proximal end, the influence of the drug delivery tube 3 on the sealed connection can be reduced compared to the connection at the distal end of the drug storage ring 4. The welding connection form of the two annular surfaces can ensure the reliability of the seal.

[0086] Secondly, from the perspective of being able to provide strong static pressure extrusion, referring to the attached figure, the end of the distal cone section 12 of the medicine supply balloon 5 is connected to the radial outer side wall of the medicine storage ring 4 at the proximal end, which can concentrate the pressure of the medicine supply balloon 5 on the proximal part of the medicine storage ring 4, thereby ensuring the static pressure effect of the medicine supply balloon 5 on the inside of the medicine storage ring 4, making the pressure inside the medicine storage ring 4 equal to the internal pressure of the medicine supply balloon 5 to the greatest extent, and ensuring the force for squeezing the medicine downstream.

[0087] On the premise that the pressure of the medicine supply balloon 5 is concentrated on the proximal portion of the medicine storage ring 4 , in order to make the pressure inside the medicine storage ring 4 equal to the internal pressure of the medicine supply balloon 5 , the medicine inlet 41 is arranged on the end face of the medicine storage ring 4 on the proximal side.

[0088] Furthermore, in order to ensure the interconnected space between the drug storage ring 4 and the drug supply balloon 5 and to restore the pressure of the two different spaces to be the same, the drug inlet 41 includes an annular drug inlet 41, which is concentrically arranged with the drug storage ring 4 to ensure uniform drug administration.

[0089] At the same time, the width of the annular drug inlet 41 is not greater than one-fourth of the width of the drug storage ring 4. This setting angle is mainly carried out from two aspects. On the one hand, it can enable the drug to be input and stored in the drug storage ring 4, and on the other hand, it does not affect the structural strength of the drug storage ring 4 itself.

[0090] Furthermore, in order to maintain the connection between the drug storage ring 4 and the outer tube 6, the present embodiment fully considers the anchoring of the drug storage ring 4 structure. Specifically, a plurality of reinforcing ribs 42 are connected to the annular end face on the proximal side of the drug storage ring 4, and the plurality of reinforcing ribs 42 are welded to the outer wall of the outer tube 6.

[0091] The proximal end of the reinforcing rib 42 is connected to the connection point of the medicine supplying balloon 5 on the outer tube 6, that is, the medicine storage ring 4, the reinforcing rib 42, the medicine supplying balloon 5 and the outer tube 6 can be connected.

[0092] The distal end of the reinforcing rib 42 is connected to the end face of the proximal end of the drug storage ring 4 and is connected to the radial root of the drug storage ring 4 where the drug inlet 41 is not provided. This arrangement corresponds to the full welding and heat sealing of the inner annular wall of the drug storage ring 4 and the outer wall of the outer tube 6. More preferably, each reinforcing rib 42 and the outer wall of the outer tube 6 are also fully welded and heat-sealed, which can stably and reliably anchor the drug storage ring 4 and ensure that the drug storage ring 4 is connected to the inside of the drug supply balloon 5, avoiding the risk of loosening of the drug storage ring 4 and formation of gaps between it and the outer tube 6.

[0093] In another specific embodiment, the drug release tube 2 and the drug delivery tube 3 are the same pipeline, including a plurality of drug release tubes 2 and drug delivery tubes 3 arranged at intervals, and the plurality of drug release tubes 2 and drug delivery tubes 3 are evenly distributed around the circumference of the drug balloon 1 .

[0094] Through the above-mentioned arrangement, it is possible to ensure uniform drug delivery around the drug balloon 1, form a three-dimensional drug delivery state at the lesion site inside the blood vessel, and meet the treatment needs.

[0095] From the perspective of facilitating connection and enabling the drug delivery system to follow the bending of the balloon, the drug release tube 2, the drug delivery tube 3 and the drug storage ring 4 are made of the same material, including a flexible polymer material. It should be pointed out that following the bending of the balloon does not mean following the contraction and deformation of the balloon. Based on the efficiency of drug release under static pressure, the shapes of the drug release tube 2 and the drug delivery tube 3 in this embodiment do not change. They can only follow the deformation of the balloon to change their retracted and released positions in the radial direction of the balloon, so that they can achieve the purpose of delivering and releasing drugs under pressure.

[0096] The diameters of the drug release tube 2 and the drug delivery tube 3 are 30%-100% of the wall thickness of the drug balloon 1 and can be adjusted according to the pressure conditions.

[0097] Based on the structural perspective that the medicine supplying balloon 5 is non-compliant and does not deform, the material of the medicine supplying balloon 5 includes polyethylene, polyester, polyethylene terephthalate, nylon or polyurethane.

[0098] Combination Figure 4-Figure 5From the perspective of ultrasonic permeation, the ultrasonic component 8 includes one or more groups arranged inside the drug balloon 1, and each group of the ultrasonic component 8 includes an ultrasonic cable 81 and an ultrasonic electrode sheet 82. Multiple groups of ultrasonic components 8 can be evenly spaced around the circumference of the drug balloon 1, which can enhance the uniformity of ultrasonic permeation.

[0099] The outer tube 6 includes a cable cavity 62 , and the ultrasound cable 81 extends from the inside of the drug balloon 1 and is connected to an external ultrasound device through the cable cavity 62 .

[0100] The balloon sound-conducting liquid cavity 15 is filled by filling the sound-conducting liquid. The outer tube 6 includes a pressure-charging cavity 63 for filling the sound-conducting liquid. The pressure-charging cavity 63 is communicated with the balloon sound-conducting liquid cavity 15 .

[0101] From the perspective of facilitating control, the proximal end of the outer tube 6 is connected to an operating connector 9, which includes a charging port 91, a cable port 92 and a drug filling port 93. The drug filling port 93 is connected to the drug delivery cavity 61, the charging port 91 is connected to the charging cavity 63, and the cable port 92 is connected to the cable cavity 62.

[0102] By docking the external charging device with the charging port 91, connecting the ultrasonic cable 81 extending from the cable port 92 to the external ultrasonic device, and connecting the charging port 93 to the external pressurized charging component, the filling of the sound-conducting liquid, ultrasonic control and pressurized charging operations can be performed respectively.

[0103] Paclitaxel liquid drugs can be introduced into the drug filling port 93 through the external pressurized drug filling component, and delivered to the drug supply balloon 5 and the drug storage ring 4 through the drug delivery cavity 61 of the outer tube 6, so that the external pressurized drug filling component can maintain the static pressure of the drug supply balloon 5 and the drug storage ring 4 in the form of continuous drug delivery and static pressure, thereby continuously releasing the liquid drug under the action of static pressure extrusion.

[0104] At the same time, during the operation, the drug content and drug components of the administered drugs can be dynamically changed to achieve the technical effect of specifically adjusting the drug administration and dosage according to the specific actual degree of the lesion.

[0105] The present invention also provides an ultrasonic osmosis treatment device for continuous administration of liquid medicine and improving the treatment effect under the action of ultrasonic osmosis.

[0106] The ultrasonic osmosis treatment device includes an ultrasonic device and the ultrasonic osmosis self-perfusion drug balloon catheter mentioned above. The ultrasonic device is electrically connected to the ultrasonic component 8 through an ultrasonic cable 81.

[0107] The proximal end of the inner tube 7 is connected to the outer tube 6 at the guide wire port. During use, the tail end of the guide wire is inserted into the balloon tip 14 and extended out of the guide wire port. Under the guidance of the guide wire, the ultrasonic osmosis self-infusion drug balloon catheter is sent into the blood vessel through the operating connector 9.

[0108] When the drug balloon 1 reaches the lesion site, the sound-conducting liquid is filled into the drug balloon 1 through the filling port 91 so that the drug balloon 1 fits the lesion site after being filled, and the liquid drug is pressurized into the drug storage ring 4 through the filling port 93 and the drug delivery cavity 61 on the outer tube 6, and the ultrasonic equipment is turned on.

[0109] Under the pressurized action of the drug storage ring 4, the drug delivery tube 3 and the drug release tube 2, the filled liquid drug is continuously released at the lesion site through the nano-scale drug release micropores 21 evenly distributed on the drug release tube 2. At the same time, the ultrasonic wave generated by the ultrasonic component 8 forms temporary micropores on the cell membrane of the lesion site, so that the released liquid drug acts on the lesion site and is absorbed.

[0110] In order to ensure the safety of treatment, during the treatment process, the blood at the proximal end of the drug balloon 1 enters the inner tube 7 through the self-infusion hole 71 and flows normally from the balloon tip 14 to the distal downstream of the drug balloon 1;

[0111] After the treatment is finished, the sound-conducting liquid in the drug balloon 1 is sucked out, and the pressurized drug supply is stopped. After the drug balloon 1 is deflated, the sonophoresis self-perfusion drug balloon catheter is completely withdrawn from the blood vessel.

[0112] The ultrasonic permeation treatment device of the present invention can deliver liquid drugs in the vascular endothelium by using the ultrasonic effect, relying on ultrasound and microbubble technology, and significantly improving the local penetration and therapeutic effect of drugs under the premise of improving the drug administration conditions.

[0113] The ultrasonic component 8 is installed on the inner tube 7 inside the drug balloon 1. At the same time, a temperature sensor also installed on the inner tube 7 is also arranged inside the balloon acoustic liquid chamber 15, which can be used for real-time monitoring during the treatment process. The ultrasonic temperature generator of the ultrasonic equipment is set at 37-42°C, and the ultrasonic technical parameters are set as follows:

[0114] The frequency of low-frequency ultrasound is 20kHz-3MHz, which can effectively cause microbubble oscillation and pore-forming effect.

[0115] By using low to medium intensity, preferably 0.5-2 W / cm 2 , for drug delivery. Too high an intensity may cause thermal effects and tissue damage, while too low an intensity may not effectively activate microbubbles and enhance drug penetration.

[0116] Incorporating pulsed mode rather than continuous wave for drug delivery reduces heat accumulation while maintaining effective mechanical effects.

[0117] It should be noted that, in the absence of conflict, the features in the embodiments of this application may be combined with each other.

[0118] 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 sonophoresis self-perfusion drug balloon catheter, characterized in that: include: Drug-eluting balloons, balloon catheters, and drug delivery systems; The drug delivery system comprises a drug release tube, a drug delivery tube and a drug storage ring which are arranged in sequence from far to near, and a drug supply balloon is arranged on the outer side of the drug storage ring; The drug balloon comprises a balloon body, a distal cone section and a proximal cone section, the drug release tube is connected to the balloon body and extends along the axial direction of the balloon body, and the drug release tube is uniformly distributed with nano-scale drug release micropores; The balloon catheter comprises an outer tube, the drug delivery tube is connected to the outer tube and the proximal cone section, and the drug storage ring is arranged at the proximal side of the drug balloon and is an annular clamp on the outer side of the outer tube; The proximal end of the drug delivery tube is connected to the drug storage ring, and the lumen of the drug delivery tube is in communication with the annular lumen of the drug storage ring; The drug supply balloon comprises a non-compliant balloon, the two ends of which are respectively sealed and connected to the drug storage ring and the outer side wall of the outer tube, the outer tube is provided with a drug delivery cavity, the drug delivery cavity is communicated with the inner cavity of the drug supply balloon, and the drug storage ring is provided with a drug inlet capable of communicating with the inner cavity of the drug supply balloon; An inner tube is arranged inside the outer tube, and a plurality of self-infusion holes are arranged between the inner tube and the outer tube, the self-infusion holes are communicated with the lumen of the inner tube, the inner tube passes through the entire length direction of the drug balloon and is communicated with the balloon tip of the drug balloon, and the self-infusion holes are arranged at the proximal side of the drug supply balloon; The drug balloon comprises a balloon guide wire cavity and a balloon sound-conducting liquid cavity, and an ultrasonic component is arranged inside the balloon sound-conducting liquid cavity.

2. The ultrasound-enhanced self-perfusion drug balloon catheter according to claim 1, characterized in that: The drug release tube is welded or bonded to the outer wall of the balloon body, the drug delivery tube is welded or bonded to the outer wall of the outer tube and the outer wall of the proximal cone section, and the inner annular wall of the drug storage ring is fully welded and heat-sealed to the outer wall of the outer tube.

3. The ultrasound-enhanced self-perfusion drug balloon catheter according to claim 1, characterized in that: The distal end of the medicine supply balloon is connected to the outer side wall of the medicine storage ring at the proximal end, and the proximal end of the medicine supply balloon is connected to the outer side wall of the outer tube.

4. The ultrasound-enhanced self-perfusion drug balloon catheter according to claim 1, characterized in that: The drug inlet is arranged on the end surface of the drug storage ring located on the proximal side, and the drug inlet includes an annular drug inlet, the annular drug inlet is arranged concentrically with the drug storage ring, and the width of the annular drug inlet is not greater than one quarter of the width of the drug storage ring, and a plurality of reinforcing ribs are connected to the end surface of the proximal side of the drug storage ring, and the plurality of reinforcing ribs are welded to the outer side wall of the outer tube; The proximal end of the reinforcing rib is connected to the connection point of the medicine supply balloon on the outer tube, and the distal end of the reinforcing rib is connected to the end surface of the proximal end of the medicine storage ring and is connected to the radial root of the medicine storage ring where the medicine inlet is not opened.

5. The sono-osmotic self-perfusion drug balloon catheter according to any one of claims 1 to 4, characterized in that: The drug release tube and the drug delivery tube are of the same root, including a plurality of tubes arranged at intervals, and the plurality of drug release tubes and the drug delivery tubes are evenly distributed around the circumference of the drug balloon.

6. The sonophoresis self-perfusion drug balloon catheter according to claim 5, characterized in that: The drug release tube, the drug delivery tube and the drug storage ring are made of the same material, including flexible polymer material. The diameters of the drug release tube and the drug delivery tube are 30%-100% of the wall thickness of the drug balloon.

7. The sonophoresis self-perfusion drug balloon catheter according to claim 5, characterized in that: The material of the medicine supplying balloon includes polyethylene, polyester, polyethylene terephthalate, nylon or polyurethane.

8. The ultrasound-enhanced self-perfusion drug balloon catheter according to claim 5, characterized in that: The ultrasonic assembly includes one or more groups arranged inside the drug balloon, and each group of the ultrasonic assembly includes an ultrasonic cable and an ultrasonic electrode sheet; The outer tube comprises a cable cavity, and the ultrasound cable extends from the interior of the drug balloon and is connected to an external ultrasound device through the cable cavity.

9. The sonophoresis self-perfusion drug balloon catheter according to claim 8, characterized in that: The balloon sound-conducting liquid cavity is filled by filling the sound-conducting liquid, and the outer tube includes a pressure-charging cavity for filling the sound-conducting liquid, and the pressure-charging cavity is connected to the balloon sound-conducting liquid cavity; The proximal end of the outer tube is connected with an operating joint, and the operating joint includes a charging port, a cable port and a drug filling port. The drug filling port is connected with the drug delivery cavity, the charging port is connected with the charging cavity, and the cable port is connected with the cable cavity.

10. A sonophoresis treatment device, characterized in that: The invention comprises an ultrasonic device and an ultrasonic osmosis self-perfusion drug balloon catheter according to any one of claims 1 to 9, wherein the ultrasonic device is electrically connected to the ultrasonic component through an ultrasonic cable; The proximal end of the inner tube is connected to the outer tube at the guide wire port, the tail end of the guide wire is inserted into the balloon tip and extended out of the guide wire port, and the ultrasound-enhanced self-perfusion drug balloon catheter is sent into the blood vessel through the operating joint under the guidance of the guide wire; When the drug balloon reaches the lesion site, the sound-conducting liquid is filled into the drug balloon so that the drug balloon fits the lesion site after being filled, and the liquid drug is pressurized and filled into the drug storage ring through the drug delivery cavity on the outer tube, and the ultrasonic device is turned on; Under the pressure of the drug storage ring, drug delivery tube and drug release tube, the filled liquid drug is released at the lesion site through the nano-scale drug release micropores evenly distributed on the drug release tube. At the same time, the ultrasonic wave generated by the ultrasonic component forms temporary micropores on the cell membrane of the lesion site, so that the released liquid drug acts on the lesion site and is absorbed; During the treatment, the blood at the proximal end of the drug balloon enters the inner tube through the self-perfusion hole and flows normally from the balloon tip to the distal end downstream of the drug balloon; After the treatment is finished, the ultrasonic perfusion liquid in the drug balloon is sucked out, the pressurized drug supply is stopped, and after the drug balloon is deflated, the ultrasonic perfusion drug balloon catheter is completely withdrawn from the blood vessel.

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